FDA -
Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:
11/03/97 ISR Number: 1000000548-7 Report Type: Expedited (15-Day) Company Report # 8558/20246 Age: Gender:
I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Death Abortion Spontaneous
Nos Consumer Depo-Provera PS INTRAMUSCULAR
Complications Of
Maternal Company
Exposure To
Therapeutic Representative
Drugs
Drug Ineffective
Pregnancy Nos
Date:
11/03/97 ISR Number:
1000000668-7 Report Type: Expedited
(15-Day) Company Report # 4201/11839 Age:74 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Endometrial Cancer Nos Health Provera Tablets PS
ORAL 2.5MG/DAY;ORA
Initial or
Prolonged Menorrhagia Professional L
Premarin C
UNKNOWN
Hyzaar C
Date:
11/03/97 ISR Number:
1000000731-0 Report Type: Expedited
(15-Day) Company Report #
8-97283-014L Age:54 YR Gender:
Female I/FU: F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Disability Blindness Nos Health Prempro PS ORAL 1 TABLET ONCE
Retinal Vein Thrombosis Professional
DAILY ORAL
Company
Representative
Date:
11/03/97 ISR Number:
1000000742-5 Report Type: Expedited
(15-Day) Company Report # 9710/20246 Age:18 YR Gender: Female I/FU:
F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Chest Pain Consumer Depo-Provera PS INTRAMUSCULAR 150
Initial or
Prolonged Dyspnoea Nos Company
MG-1Q3MO;IM
Infertility
Female Representative
Ovarian Cyst
Pain Nos
Pulmonary Embolism
Date:
11/03/97 ISR Number:
1000000750-4 Report Type: Expedited
(15-Day) Company Report # 7743/20246 Age: Gender:
Male I/FU: F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Congenital
Anomaly Congenital Ear Consumer Depo-Provera PS INTRAMUSCULAR 150MG 1Q3MO;
Malformation Nos Company
IM
Representative
Date: 11/03/97 ISR Number: 1000000777-2 Report Type: Expedited (15-Day) Company Report # 9406/20246 Age:27 YR Gender: Female I/FU:
F
Outcome
Hospitalization
-
Initial or
Prolonged
21-Dec-2001 11:15 AM Page:
1
FDA -
Adverse Event Reporting System (AERS)
Freedom Of
Information (FOI) Report
Other
PT Report Source Product Role
Manufacturer Route Dose Duration
Convulsions Nos Health Depo-Provera PS INTRAMUSCULAR 150 MG - 1
Disturbance In
Attention Professional
DOSE; IM
Dizziness (Excl
Vertigo) Company
Grand Mal
Convulsion Representative
Hyperventilation Other
Hypoaesthesia
Insomnia
Mental Disorder Nos
Mood Swings
Nausea
Nervousness
Weight Increased
Date:
11/03/97 ISR Number: 3003320-0 Report Type: Periodic Company Report # WAES
97071639 Age:71 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route
Dose Duration
Abdominal
Distension Consumer Tab Fosamax PS ORAL 10MG/DAILY/PO
Dermatitis Nos Tab Provera SS ORAL PO
Flatulence Tab
Premarin SS ORAL PO
Date:
11/03/97 ISR Number: 3007672-7
Report Type: Periodic
Company Report # WAES 97081479
Age:75 YR Gender: Female
I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Breast Pain Consumer Fosamax PS ORAL 10 MG DAILY
Hiatus Hernia PO
Oesophageal Pain
Prempro SS
Cardizem Cd C
Acyclovir C
Centrum Silver C
Vitamin
E C
Zinc C
Linseed Oil C
Date:
11/03/97 ISR Number: 3010822-X Report Type: Periodic Company Report # WAES 97072139 Age:76 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Abdominal
Distension Consumer Fosamax PS ORAL 10MG/DAILY/PO
Constipation
Provera SS ORAL UNK/UNK/PO
Neck Pain
Vasotec C
Vaginal
Candidiasis
Premarin C
Tums C
Calcium C
Date:
11/03/97 ISR Number: 3028879-9 Report Type: Periodic Company Report # 8-97220-002S Age:68 YR Gender: Female I/FU:
I
Outcome PT Report Source
Product Role Manufacturer Route
Dose Duration
Other Abdominal Pain Nos Consumer Methotrexate
PS
ORAL 7.5 MG/WEEK
Pelvic Congestion
ORAL
Prempro SS ORAL 0.625 MG
DAILY ORAL
21-Dec-2001 11:15 AM Page:
2
FDA -
Adverse Event Reporting System (AERS)
Freedom Of
Information (FOI) Report
Date:
11/03/97 ISR Number: 3028927-6 Report Type: Periodic Company Report # 8-97223-021S Age:52 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Haemorrhage Nos Consumer Rheumatrex PS ORAL WEEKLY ORAL
Hot Flushes Nos
Premarin SS
Premphase 14/14 SS ONE DAILY
Accupril C
Avonex C
Baclofen C
Estratest C
Midrin C
Date:
11/05/97 ISR Number: 3012481-9 Report Type: Periodic Company Report # 2392/12541 Age:41 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Fungal Rash Nos Health Depo-Provera PS 400 MG
Localised
Exfoliation Professional
1Q1MO;IM
Pruritus Nos
Date:
11/05/97 ISR Number: 3012484-4 Report Type: Periodic Company Report # 2397/12541 Age:8 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Complications Of
Maternal Consumer Depo-Provera PS IM
Exposure To
Therapeutic Company
Drugs Representative
Decreased Interest
Disturbance In
Attention
Date:
11/05/97 ISR Number: 3012490-X Report Type: Periodic Company Report # 2400/12541 Age:36 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Abortion Induced
Nos Consumer Depo-Provera PS 400 MG/DAY;IM
Complications Of
Maternal Company Effexor C
Exposure To
Therapeutic Representative
Drugs
Depression Aggravated
Foetal Disorder Nos
Nausea
Post-Partum
Haemorrhage
Pyrexia
Date:
11/05/97 ISR Number: 3012497-2 Report Type: Periodic Company Report # 2402/12541 Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Depression Nos Consumer Depo-Provera PS 8 DOSE;IM
Osteoporosis Nos Company
Posture Abnormal Representative
21-Dec-2001 11:15 AM
Page: 3
FDA -
Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:
11/05/97 ISR Number: 3012500-X Report Type: Periodic Company Report # 2403/12541 Age:41 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Influenza Like Illness Health Depo-Provera PS 400 MG-1
Injection Site
Burning Professional DOSE;
IM
Injection Site
Erythema Company
Injection Site
Oedema Representative
Date:
11/05/97 ISR Number: 3012504-7 Report Type: Periodic Company Report # 2404/12541 Age:24 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Abdominal Pain Upper Health Depo-Provera Sterile
Fatigue Professional Aqueous Suspension PS INTRAMUSCULAR 200 MG-1
Injection Site
Infection
DOSE; IM
Injection Site Oedema
Pyrexia
Date: 11/05/97 ISR Number: 3030839-9 Report Type: Periodic Company Report # 2406/12541 Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Drug Ineffective Consumer Depo-Provera PS INTRAMUSCULAR 1 DOSE; IM
Menorrhagia
Date:
11/05/97 ISR Number: 3030842-9 Report Type: Periodic Company Report # 2408/12541 Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer
Route Dose Duration
Acne Nos Consumer Depo-Provera PS INTRAMUSCULAR 200 MG-1Q1MO;
Headache Nos Company
IM
Insomnia Representative
Night Sweats
Date:
11/05/97 ISR Number: 3030846-6 Report Type: Periodic Company Report # 240912541 Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Muscle Weakness
Nos Health Depo-Provera PS INTRAMUSCULAR 150 MG-1
Paraesthesia Professional
DOSE; IM, 1
Company
DO
Representative
Date:
11/05/97 ISR Number: 3030849-1 Report Type: Periodic Company Report # 2411/12541 Age:27 YR Gender: Female I/FU:
I
Outcome PT Report Source
Product Role Manufacturer Route
Dose Duration
Other Injection Site
Erythema Health Depo-Provera PS INTRAMUSCULAR IM
Injection Site
Mass Professional
Company
Representative
21-Dec-2001 11:15 AM Page:
4
FDA -
Adverse Event Reporting System (AERS)
Freedom Of Information
(FOI) Report
Date:
11/05/97 ISR Number: 3030852-1 Report Type: Periodic Company Report # 2412/12541 Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Bone Mass
Decreased Consumer Depo-Provera PS INTRAMUSCULAR IM
Company
Representative
Date:
11/05/97 ISR Number: 3030854-5 Report Type: Periodic Company Report # 2423/12541 Age: Gender:
Male I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Erectile Dysfunction Nos Health
Depo-Provera PS
Injury Nos Professional
Rectal
Haemorrhage Company
Representative
Date:
11/05/97 ISR Number: 3030857-0 Report Type: Periodic Company Report # 242812541 Age:50 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Burning Sensation Nos Consumer Depo-Provera
PS
INTRAMUSCULAR 250 MG-1Q
Disturbance In
Attention
1MO;IM
Epiglottitis Nos
Depo-Lupron C
Fatigue Zantac C
Hypersensitivity
Nos
Methylphenidate C
Injection Site
Erythema Ibuprofen C
Injection Site Multiple
Vitamins C
Inflammation
Tums C
Injection Site Oedema
Injection Site Pain
Lacrimation Increased
Lymphadenopathy
Pain Nos
Pharyngitis Nos
Postnasal Drip
Pyrexia
Rash Erythematous
Sedation
Sensation Of Pressure
Nos
Swelling Nos
Date:
11/05/97 ISR Number: 3030861-2 Report Type: Periodic Company Report # 2429/12541 Age: Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Injection Site
Reaction Health Depo-Provera PS IM
Nos Professional
Urticaria Nos
Company
Representative
Date:
11/05/97 ISR Number: 3030865-X Report Type: Periodic Company Report # 2430/12541 Age:26 YR Gender: Female I/FU:
I
Outcome PT
Other Abnormal Behaviour Nos
Dizziness (Excl
Vertigo)
Migraine Nos
21-Dec-2001 11:15 AM Page:
5
FDA -
Adverse Event Reporting System (AERS)
Freedom Of
Information (FOI) Report
Mood Swings
Photophobia
Vertigo Report Source Product Role
Manufacturer Route Dose
Duration
Vomiting Nos Health Depo-Provera PS 1 DOSE
Professional
Company
Representative
Date:
11/05/97 ISR Number: 3030868-5 Report Type: Periodic Company Report # 2431/12541 Age:21 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Drug Ineffective Health Depo-Provera PS INTRAMUSCULAR 150
Professional
MG-1Q3MO;IM
Company Augmentin C
Representative Biaxin C
Meclizine C
Vancenase Aq C
Date:
11/05/97 ISR Number: 3030871-5 Report Type: Periodic Company Report # 2434/12541 Age: Gender: Female
I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Injection Site
Necrosis Health Depo-Provera PS INTRAMUSCULAR IM
Professional
Company
Representative
Date:
11/05/97 ISR Number: 3030873-9 Report Type: Periodic Company Report # 2436/12451 Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Acne Nos Health Depo-Provera PS INTRAMUSCULAR 1 DOSE (S)-1
Alopecia Professional
DOSE; IM
Hair Growth
Abnormal Company
Scar Representative
Date:
11/05/97 ISR Number: 3030876-4 Report Type: Periodic Company Report # 2444/12541 Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Alopecia Health Depo-Provera PS INTRAMUSCULAR IM,(A) 2
MON
Professional
Provera C
Company
Representative
Date: 11/05/97 ISR Number: 3030879-X Report Type: Periodic Company Report # 2446/12541 Age:41 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Injection Site
Erythema Health Depo-Provera PS INTRAMUSCULAR 300 MG-1
Injection Site Mass Professional
DOSE; IM
Injection Site
Pain Company Sinemet C
Representative Glyburide C
21-Dec-2001 11:15 AM
Page: 6
FDA - Adverse
Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:
11/05/97 ISR Number: 3030881-8 Report Type: Periodic Company Report # 2449/12541 Age:52 YR
Gender: Male I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Pain In Limb Health Depo-Provera PS INTRAMUSCULAR 400
Professional MG-1Q1MO;IM
Company
Representative
Date:
11/05/97 ISR Number: 3030884-3 Report Type: Periodic Company Report # 2452/12541 Age:58 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Breast Enlargement Consumer
Depo-Provera PS INTRAMUSCULAR 200
Weight Increased Company MG-1Q1MO;IM 2
MON
Representative Zoloft C
Date:
11/05/97 ISR Number: 3030885-5 Report Type: Periodic Company Report # 2455/12541 Age:52 YR Gender: Male I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Pain In Limb Health Depo-Provera PS INTRAMUSCULAR 400
Professional
MG-1Q1MO;IM,
(A)
Multiple Psychiatric
Medications C
Date:
11/05/97 ISR Number: 3030888-0 Report Type: Periodic Company Report # 2388/12541 Age: Gender:
Female I/FU: F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Abdominal Distension Consumer Od-Depo-Provera
PS
INTRAMUSCULAR OD-1000 MG-1
Accidental
Overdose Company
DOSE;IM
(Therapeutic
Agent) Representative Depo-Provera SS INTRAMUSCULAR 200
Bursitis
MG-1Q3MO;IM
Headache Nos
Zoloft C
Date:
11/05/97 ISR Number: 3030894-6 Report Type: Periodic Company Report # 2390/12541 Age: Gender: Female I/FU:
F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Abdominal Pain
Nos Consumer Depo-Provera
PS
INTRAMUSCULAR 400
Dysmenorrhoea Company
MG-1Q1MO;IM,
Fatigue Representative
(A)
Galactorrhoea
Zoloft C
Irritability
Depakote C
Loss Of Libido
Mood Alteration Nos
Vaginal Haemorrhage
Date:
11/06/97 ISR Number: 3005479-8 Report Type: Direct Company Report # Age: Gender: Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Uterine Cancer
Nos
Prempro PS
21-Dec-2001 11:15 AM
Page: 7
FDA -
Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:
11/06/97 ISR Number: 3005483-X Report Type: Direct Company Report # Age: Gender: Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Endometrial Cancer
Stage
Prempro PS
Ii
Date:
11/10/97 ISR Number:
1000002108-0 Report Type: Expedited
(15-Day) Company Report #
8-97307-003R Age:48 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Abdominal Distension Consumer Premphase Tablets
PS
ORAL 1 TABLET ONCE
Initial or
Prolonged Cervical Carcinoma Nos DAILY
ORAL
Other Pain Nos
Aleve C
PRN
Weight Increased
Date:
11/10/97 ISR Number: 3020290-X
Report Type: Periodic
Company Report # JAUSA-27604
Age:35 YR Gender: Female
I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Albumin Globulin Ratio Health Sporanox PS ORAL 200 MG DAILY
Increased Professional
ORAL, ON
Gamma-Glutamyltransferase
SPORANOX
Increased
Provera SS
Mean Cell Volume
Increased
Date:
11/12/97 ISR Number: 3000038-5 Report Type: Expedited (15-Day) Company Report # Age:74 YR
Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Endometrial Cancer Nos Health Provera Tablets PS
ORAL 2.5
Initial or
Prolonged Menorrhagia Professional
MG/DAY;ORAL
Permarin SS ORAL .625
MG/DAY;ORAL
Hyzaar C
Date:
11/12/97 ISR Number: 3000254-2 Report Type: Expedited (15-Day) Company Report # 10045/20246 Age: Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Accidental
Overdose Foreign Od-Depo-Provera
(Therapeutic
Agent) Health Contraceptive
Condition
Aggravated Professional Injection (150 Mg/Ml
PS
INTRAMUSCULAR OD-150
Psychotic Disorder
Nos Company
MG-1Q2WK;IM
Representative
Date:
11/12/97 ISR Number: 3000257-8 Report Type: Expedited (15-Day) Company Report # 10006/20246 Age: Gender:
I/FU: I
Outcome PT Report Source
Product Role Manufacturer Route
Dose Duration
Death Accidental Exposure Health Depo-Provera
Intra-Uterine
Death Professional
Contraceptive
Injection (150 Mg/Ml
) PS INTRAMUSCULAR 150
MG-1
DOSE; IM
21-Dec-2001 11:15 AM Page:
8
FDA -
Adverse Event Reporting System (AERS)
Freedom Of
Information (FOI) Report
Date:
11/12/97 ISR Number: 3000264-5 Report Type: Expedited (15-Day) Company Report # 9795/20246 Age:43 YR Gender: Female I/FU:
I
Outcome PT Report Source
Product Role Manufacturer Route
Dose Duration
Life-Threatening Asthma Aggravated Foreign Depo-Provera
Hospitalization
- Chest Pain Health
Contraceptive
Initial or
Prolonged Cough Professional Injection (150
Other Lower Respiratory
Tract Company Mcg/Ml) PS 150
Infection Nos Representative
MG-1Q3MO;IM
Pulmonary
Embolism Terbutaline C
Sputum Abnormal
Nos
Beclomethasone C
Date:
11/12/97 ISR Number: 3000515-7 Report Type: Expedited (15-Day) Company Report # 9244/20246 Age: Gender: Male
I/FU: F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Apgar Score Low Foreign Depo-Provera
Initial or
Prolonged Breech Delivery Health Contraception
Complications Of
Maternal Professional Injection PS INTRAMUSCULAR 150 MG-1
Exposure To
Therapeutic Company
DOSE; IM
Drugs Representative
Infection Nos
Date:
11/12/97 ISR Number: 3097789-3 Report Type: Expedited (15-Day) Company Report # 001-0945-970414 Age: Gender:
I/FU: F
Outcome PT Report Source Product Role Manufacturer
Route Dose Duration
Congenital
Anomaly Blood Creatinine Health Neurontin PS 400 MG,TID, /
Increased Professional
EXPOSURE
Complications Of
Maternal INUTERO
Exposure To
Therapeutic
Tegretol SS ORAL 400 MG,TID,
Drugs EXPOSURE
IN
Hydronephrosis
UTERO
Multiple Congenital Depo-Provera SS STOPPED 1
Abnormalities
MONTH BEFORE
Vesico-Ureteric
Reflux
CONCEPTION
Prenatal Vitamins SS
Date:
11/17/97 ISR Number: 3000849-6 Report Type: Expedited (15-Day) Company Report # 8-97310-001R Age:53 YR Gender: Female I/FU:
I
Outcome PT Report Source
Product Role Manufacturer Route
Dose Duration
Other Endometrial Cancer Nos Consumer Prempro
PS
ORAL 1 TABLET ONCE
Uterine Cancer
Nos
DAILY ORAL
Prozac C
Various
Antidepressants C
Date:
11/17/97 ISR Number: 3000997-0 Report Type: Expedited (15-Day) Company Report # 8-97315-001R Age:65 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Hospitalization
- Cerebral Infarction Foreign Premique PS ORAL 1 TABLET ONCE
Initial or
Prolonged Transient Ischaemic Health DAILY ORAL
Attack Professional
21-Dec-2001 11:15 AM
Page: 9
FDA -
Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:
11/18/97 ISR Number: 3005302-1 Report Type: Direct Company Report # Age:26 YR Gender:
Female I/FU: I
Outcome PT Report Source Product Role Manufacturer
Route Dose Duration
Life-Threatening Amenorrhoea Nos Depo
Provera PS Upjohn INTRAMUSCULAR
Hospitalization
- Amnesia
Initial or
Prolonged Anxiety Nec
Disability Appetite Disorder Nos
Other Confusion
Delusion Nos
Depression Nos
Feeling Abnormal
Feeling Cold
Hot Flushes Nos
Irritability
Panic Attack
Thirst
Date:
11/19/97 ISR Number: 3001783-8 Report Type: Expedited (15-Day) Company Report # 4213/11839 Age:50 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Abdominal Pain Nos Foreign Provera PS ORAL 1200 MG/DAY;
Initial or
Prolonged Renal Infarct Health
ORAL
Other
Professional
Doxifluridine C
Company
Morphine C
Representative Morphine C
Date:
11/19/97 ISR Number: 3001825-X Report Type: Expedited (15-Day) Company Report # 8-97251-002R Age:50 YR Gender: Female I/FU:
F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Drug Ineffective Health Prempro Tablets PS
ORAL 1 TABLET ONCE
Initial or
Prolonged Menorrhagia Professional
DAILY ORAL
Other Vaginal Haemorrhage Tenormin C
Required
Norvasc C
Intervention
to
Zocor C
Prevent
Permanent
Impairment/Damage
Date:
11/19/97 ISR Number: 3001835-2 Report Type: Expedited (15-Day) Company Report # 9750/20246 Age: Gender:
I/FU: F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Death Abortion Spontaneous
Nos Health Depo-Provera
Hospitalization
-
Professional Contraceptive
Initial or
Prolonged
Company Injection
150mg/Ml PS INTRAMUSCULAR
Representative
Date:
11/19/97 ISR Number: 3001836-4 Report Type: Expedited (15-Day) Company Report # 9962/20246 Age:48 YR Gender: Female I/FU:
F
Outcome PT
Hospitalization
- Anaemia Nos
Initial or
Prolonged Bundle Branch Block Left
Other Chest Pain
Coronary Artery
Disease
Nos
21-Dec-2001 11:15 AM
Page: 10
FDA -
Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Dyspepsia
Feeling Cold
Feeling Hot Report Source Product Role
Manufacturer Route Dose Duration
Hypercholesterolaemia
Foreign
Depo-Provera
Insomnia Health Contraceptive
Myocardial
Infarction Professional Injection 150mg PS INTRAMUSCULAR 150 MG
Nausea Company
1Q12WK;IM
Representative Estraderm
Patch C
Date:
11/19/97 ISR Number: 3001837-6 Report Type: Expedited (15-Day) Company Report # 9749/20246 Age: Gender:
I/FU: F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Death Abortion Spontaneous
Nos Health Depo-Provera
Hospitalization
-
Professional Contraceptive
Initial or
Prolonged
Company Injection
150mg PS INTRAMUSCULAR
Representative
Date:
11/19/97 ISR Number: 3001838-8 Report Type: Expedited (15-Day) Company Report # 8910/20246 Age: Gender:
Female I/FU: F
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Abortion Spontaneous
Nos Consumer Depo-Provera
Aggression Company Conctraceptive
Alopecia Representative
Injection 150 Mg PS INTRAMUSCULAR 150 MG- 1
Depression Nos
DOSE; IM
Hostility
Date:
11/21/97 ISR Number: 3002366-6 Report Type: Expedited (15-Day) Company Report # 8-97317-006R Age:46 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Menorrhagia
Prempro PS ORAL 1 TABLET ONCE
Initial or
Prolonged
DAILY ORAL/ 8
MIU QD SC
Betaseron SS SUBCONJUNCTIVAL 8 MIU QD SC
Zoloft C
Amantadine C
Date:
11/21/97 ISR Number: 3002558-6 Report Type: Expedited (15-Day) Company Report # 8-97318-009R Age:75 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Adenocarcinoma Nos
Health Prempro
Tablets PS ORAL TABLET ONCE
Cyst Nos Professional DAILY ORAL
Menorrhagia
Date:
11/26/97 ISR Number: 3002768-8 Report Type: Expedited (15-Day) Company Report # 8-97318-006R Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Endometrial Cancer Nos Health Prempro PS
ORAL 1 TABLET ONCE
Professional
DAILY ORAL
21-Dec-2001 11:15 AM Page:
11
FDA -
Adverse Event Reporting System (AERS)
Freedom Of
Information (FOI) Report
Date:
11/26/97 ISR Number: 3002864-5 Report Type: Expedited (15-Day) Company Report # 10107/20246 Age: Gender:
I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Death Abortion Induced Foreign Depo-Provera PS INTRAMUSCULAR
150MG -
Incomplete Nos Health
1Q3MO;IM
Complications Of
Maternal Professional Tylenol C
Exposure To
Therapeutic Company Vitamins C
Drugs Representative
Date:
11/26/97 ISR Number: 3002870-0 Report Type: Expedited (15-Day) Company Report # 8207/20246 Age: Gender: Male I/FU:
F
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Congenital
Anomaly Complications Of
Maternal Health Depo-Provera PS 150 MG-1Q3MO;
Exposure To
Therapeutic Professional IM
Drugs Company
Hypospadias Representative
Date:
12/01/97 ISR Number: 3003181-X Report Type: Expedited (15-Day) Company Report # 4221/11839 Age: Gender: Male I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Congenital
Anomaly Attention Consumer Provera PS ORAL ORAL
Deficit/Hyperactivity
Company
Disorder Representative
Date:
12/01/97 ISR Number: 3003184-5 Report Type: Expedited (15-Day) Company Report # 4201/11839 Age:74 YR Gender: Female I/FU:
F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Endometrial Cancer Nos Health Provera PS ORAL 2.5 MG/DAY;
Initial or
Prolonged
Professional
ORAL
Premarin SS ORAL .625 MG/DAY;
ORAL
Hyzaar C
Date:
12/01/97 ISR Number: 3003240-1 Report Type: Expedited (15-Day) Company Report # 9440/20246 Age:20 YR Gender: Female I/FU:
F
Outcome PT Report Source
Product Role Manufacturer Route
Dose Duration
Hospitalization
- Abdominal Pain Nos Health Depo-Provera PS INTRAMUSCULAR 150
Initial or
Prolonged Blood Glucose
Increased Professional
MG-1Q12WK; IM
Other Nervousness Company
Pain Nos Representative
Thyrotoxicosis
Date:
12/01/97 ISR Number: 3052950-9 Report Type: Periodic Company Report # 8-97220-025N Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Drug Effect Decreased Health Prempro PS ORAL 1 TABLET ONCE
Professional
DAILY
Company
Representative
21-Dec-2001 11:15 AM
Page: 12
FDA - Adverse
Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:
12/04/97 ISR Number: 3004166-X Report Type: Expedited (15-Day) Company Report # MPI-97622 Age: Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Disability Limb Deformities Nos Other Ionamin PS TRANSPLACENTAL UNKNOWN,
Congenital
Anomaly Limb Reduction Defect TRANSPLACENTA
L
Hydrodiuril SS
Valium SS
Demerol SS
Ornade SS
Donnatal SS
Provera SS
Delalutin SS
Temaril SS
Date:
12/05/97 ISR Number: 3004236-6 Report Type: Expedited (15-Day) Company Report # 97J--10298 Age:55 YR Gender: Female I/FU:
F
Outcome PT Report Source Product
Role Manufacturer
Route Dose Duration
Hospitalization
- Chest Pain Foreign Estraderm Tts
Initial or
Prolonged Dyspnoea Nos Health Trans-Therapeutic-Sy
Pulmonary
Infarction Professional stem PS TOPICAL 25 MCG, DAILY
Other TOPICAL/LOCAL
Medroxyprogesterone
Acetate SS
Date:
12/09/97 ISR Number: 3004576-0 Report Type: Expedited (15-Day) Company Report # 9710/20246 Age:18 YR Gender: Female I/FU:
F
Outcome PT Report Source Product Role
Manufacturer Route Dose Duration
Hospitalization
- Chest Pain Consumer Depo-Provera PS INTRAMUSCULAR 150
Initial or
Prolonged Dyspnoea Nos Company
MG-1Q3MO;IM
Pain Nos Representative
Pulmonary Embolism
Date:
12/09/97 ISR Number: 3004579-6 Report Type: Expedited (15-Day) Company Report # 9084/20246 Age:23 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route
Dose Duration
Disability Dehydration Health Depo-Provera PS INTRAMUSCULAR 150 MG 1 Q
Diarrhoea Nos Professional
3MO; IM
Disability Nos Company
Dry Mouth Representative
Fatigue
Headache Nos
Hot Flushes Nos
Hypertension Nos
Insomnia
Nausea
Nervousness
Night Sweats
Rigors
Weakness
Weight Increased
21-Dec-2001 11:15 AM
Page: 13
FDA -
Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:
12/09/97 ISR Number: 3004938-1 Report Type: Expedited (15-Day) Company Report # 4160/11839 Age:64 YR Gender: Female I/FU:
F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Breast Cancer Female Nos Consumer Provera
PS
ORAL ORAL
Initial or
Prolonged
Estraderm
Patch C
Disability
Date:
12/15/97 ISR Number: 3008744-3 Report Type: Expedited (15-Day) Company Report # 4102/11839 Age: Gender:
Female I/FU: F
Outcome PT Report Source
Product Role Manufacturer Route
Dose Duration
Death Abdominal Mass Nos Consumer Provera
PS
ORAL 5 MG 1Q 1DY;
Congenital
Anomaly Arrhythmia Nos
Neonatal Company
ORAL
Chorioamnionitis Representative Unspecified
Complications Of
Maternal
Anti-Emetic C
Exposure To
Therapeutic
Prenatal Vitamins C
Drugs Unspecified Iron
Connective Tissue
Supplement C
Disorder Nos
Intra-Uterine Death
Limb Reduction Defect
Date:
12/15/97 ISR Number: 3008795-9 Report Type: Expedited (15-Day) Company Report # 10180/20246 Age: Gender:
I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Congenital
Anomaly Complications Of
Maternal Consumer Depo-Provera PS INTRAMUSCULAR 150 MG/DAY;
Exposure To Therapeutic Company
IM
Drugs Representative
Congenital Clubfoot
Hydrocephalus Nos
Spina Bifida
Date:
12/15/97 ISR Number: 3008800-X Report Type: Expedited (15-Day) Company Report # 9223/20246 Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Benign Intracranial Consumer Depo-Provera
PS INTRAMUSCULAR 1 DOSE; IM
Initial or
Prolonged Hypertension Company
Headache Nos Representative
Vision Blurred
Date:
12/17/97 ISR Number: 3034571-7 Report Type: Periodic Company Report #
8-97317-015N Age:62 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Abdominal Pain Lower Consumer Prempro
PS
ORAL 1 TABLET ONCE
Alopecia DAILY
ORAL
Breast
Enlargement
Women'S Vitamin
Headache Nos
Supplement C
Uterine
Haemorrhage
Asa C
Vitamin E C
21-Dec-2001 11:15 AM Page:
14
FDA -
Adverse Event Reporting System (AERS)
Freedom Of
Information (FOI) Report
Date:
12/17/97 ISR Number: 3034573-0 Report Type: Periodic Company Report # 8-97317-016N Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Dermatitis Nos Health Prempro PS ORAL 1 TABLET ONCE
Hypersensitivity
Nos Professional
DAILY ORAL
Skin Irritation Company
Representative
Date:
12/17/97 ISR Number: 3034575-4 Report Type: Periodic Company Report # 8-97317-017N Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Constipation Health Prempro PS
ORAL 1 TABLET ONCE
Swelling Nos Professional
DAILY ORAL
Urethral Syndrome Company
Representative
Date:
12/17/97 ISR Number: 3034576-6 Report Type: Periodic Company Report # 8-97318-001N Age:74 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Vocal Cord Polyp Consumer Prempro PS
ORAL 1 TABLET ONCE
DAILY ORAL
Zantac C
Aspirin C
Azmacort C
Date:
12/17/97 ISR Number: 3034579-1 Report Type: Periodic Company Report # 8-97318-001R Age:40 YR Gender: Female I/FU:
I
Outcome PT Report Source Product Role
Manufacturer Route Dose Duration
Other Drug Ineffective Health Prempro PS ORAL 1 TABLET ONCE
Professional
DAILY ORAL
Diflucan C
Levoxyl C
Date:
12/17/97 ISR Number: 3034581-X Report Type: Periodic Company Report # 8-97318-002N Age:48 YR Gender: Female I/FU:
I
Outcome PT
Report Source
Product Role Manufacturer Route
Dose Duration
Other Arthralgia Consumer Premphase PS ORAL
TABLET ONCE
DAILY ORAL
Nonprescription
Arthritis Medication C
Date:
12/17/97 ISR Number: 3034583-3 Report Type: Periodic Company Report # 8-97318-003N Age:66 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Intermenstrual Bleeding Consumer Prempro
PS ORAL 1 TABLET ONCE
DAILY ORAL
Vitamin C
21-Dec-2001 11:15 AM
Page: 15
FDA -
Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:
12/17/97 ISR Number: 3034586-9 Report Type: Periodic Company Report #
8-97318-004N Age:51 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Drug Interaction Nos Consumer Prempro
PS
ORAL 1 TABLET ONCE
Fatigue DAILY
ORAL
Feeling Of
Relaxation
Inderal SS ORAL 20 MG TWICE
DAILY ORAL
Date:
12/17/97 ISR Number: 3034587-0 Report Type: Periodic Company Report #
8-97318-004R Age:57 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Breast Pain Consumer Prempro PS ORAL 1 TABLET ONCE
Oedema Lower Limb
DAILY ORAL
Sweating
Increased
Antibiotic
Vaginal Disorder
Nos
(Unspecified) C
Neurontin C
Date:
12/17/97 ISR Number: 3034589-4 Report Type: Periodic Company Report # 8-97318-005N Age:75 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Breast Pain Consumer Prempro PS ORAL 1 TABLET
ONCE
Nipple Pain
DAILY ORAL
Zocor C
Metoprolol C
Norvasc C
Aspirin C
Relafen C
Date:
12/17/97 ISR Number: 3034591-2 Report Type: Periodic Company Report # 8-97318-008N Age:83 YR
Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Intermenstrual Bleeding Consumer
Prempro PS ORAL 1 TABLET ONCE
DAILY ORAL
Date:
12/17/97 ISR Number: 3034593-6 Report Type: Periodic Company Report # 8-97318-009N Age:45 YR Gender: Female I/FU:
I
Outcome PT Report Source
Product Role Manufacturer Route
Dose Duration
Other Convulsions Nos Health Prempro PS ORAL 1 TABLET ONCE
Professional
DAILY ORAL 4 DAY
Company
Representative
Date:
12/17/97 ISR Number: 3034594-8 Report Type: Periodic Company Report # 8-97318-010N Age:41 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Abdominal Pain Nos Consumer Prempro
PS ORAL 1 TABLET ONCE
Hot Flushes Nos
DAILY ORAL
Intermenstrual
Bleeding
21-Dec-2001 11:15 AM
Page: 16
FDA -
Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:
12/17/97 ISR Number: 3034597-3 Report Type: Periodic Company Report # 8-97318-011N Age:60 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Abdominal Distension Consumer Prempro
PS
ORAL 1 TABLET ONCE
Intermenstrual
Bleeding
DAILY ORAL
Nausea Aspirin C
Multi Vitamin C
Date:
12/17/97 ISR Number: 3034599-7 Report Type: Periodic Company Report # 8-97321-001N Age:60 YR
Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Abdominal Distension Consumer Prempro
PS
ORAL 1 TABLET ONCE
Breast Tenderness DAILY
ORAL
Intermenstrual
Bleeding
Synthroid C
Date:
12/17/97 ISR Number: 3034601-2 Report Type: Periodic Company Report # 8-97321-002N Age:78 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Vaginal Haemorrhage Consumer Prempro
PS ORAL 1 TABLET ONCE
DAILY ORAL
Aerosept C
Unspecified
Antiemetic C
Date:
12/17/97 ISR Number: 3034604-8 Report Type: Periodic Company Report # 8-97321-002R Age: Gender:
Female I/FU: I
Outcome PT Report Source
Product Role Manufacturer Route
Dose Duration
Other Intermenstrual
Bleeding Health Prempro PS ORAL 1 TABLET ONCE
Professional
DAILY ORAL
Date:
12/17/97 ISR Number: 3034606-1 Report Type: Periodic Company Report # 8-97321-003N Age:
Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Intermenstrual
Bleeding Health Prempro PS ORAL 1 TABLET ONCE
Professional DAILY ORAL 12
MON
Date:
12/17/97 ISR Number: 3034608-5 Report Type: Periodic Company Report # 8-97321-004N Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Intermenstrual
Bleeding Consumer Prempro PS ORAL 1
TABLET ONCE
DAILY ORAL
Date:
12/17/97 ISR Number: 3034610-3 Report Type: Periodic Company Report #
8-97321-005N Age:59 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Intermenstrual
Bleeding Consumer Prempro PS ORAL 1 TABLE ONCE
Menorrhagia DAILY ORAL
21-Dec-2001 11:15 AM
Page: 17
FDA -
Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:
12/17/97 ISR Number: 3034613-9 Report Type: Periodic Company Report #
8-97321-006N Age: Gender: Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Hypoglycaemia Nos Health Prempro PS ORAL 1 TABLET ONCE
Professional DAILY ORAL 2
YR
Date:
12/17/97 ISR Number: 3034616-4 Report Type: Periodic Company Report # 8-97321-007N Age:58 YR Gender: Female I/FU:
I
Outcome PT
Report Source
Product Role Manufacturer Route
Dose Duration
Other Alopecia Consumer Prempro PS ORAL
1 TABLET ONCE
DAILY ORAL
Date:
12/17/97 ISR Number: 3034617-6 Report Type: Periodic Company Report #
8-97321-008N Age: Gender: Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Alopecia Health Prempro PS ORAL 1 TABLET ONCE
Professional DAILY ORAL
Synthroid C
Date:
12/17/97 ISR Number: 3034620-6 Report Type: Periodic Company Report #
8-97321-009N Age:50 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Depression Nos Consumer Prempro
PS
ORAL 1 TABLET ONCE
Libido Decreased
DAILY
ORAL
Estrogen C
Date:
12/17/97 ISR Number: 3034621-8 Report Type: Periodic Company Report # 8-97321-010N Age:52 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Breast Tenderness Consumer
Premphase PS ORAL 1 TABLET ONCE
DAILY ORAL
Date:
12/17/97 ISR Number: 3034624-3 Report Type: Periodic Company Report # 8-97321-011N Age:43 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Breast Lump Nos Consumer Prempro PS ORAL 1 TABLET ONCE
Chest Pain
DAILY ORAL
Date:
12/17/97 ISR Number: 3034626-7 Report Type: Periodic Company Report # 8-97321-012N Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Intermenstrual Bleeding Consumer Prempro
PS ORAL 1 TABLET ONCE
DAILY ORAL
Glucotrol C
Pravachol C
Aspirin C
21-Dec-2001 11:15 AM
Page: 18
FDA - Adverse
Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:
12/17/97 ISR Number: 3034631-0 Report Type: Periodic Company Report # 8-97321-013N Age:53 YR
Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Abdominal Pain Nos Consumer Prempro
PS
ORAL 1 TABLET ONCE
Erythema
DAILY ORAL
Intermenstrual
Bleeding
Lipitor C
Date:
12/17/97 ISR Number: 3034634-6 Report Type: Periodic Company Report # 8-97321-014N Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Intermenstrual
Bleeding Health Prempro PS ORAL 1 TABLET ONCE
Professional DAILY ORAL
Company
Representative
Date:
12/17/97 ISR Number: 3034636-X Report Type: Periodic Company Report # 8-97321-015N Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Haemorrhage Nos Health Premphase PS ORAL 1 TABLET ONCE
Professional DAILY ORAL
Company
Representative
Date:
12/17/97 ISR Number: 3034638-3 Report Type: Periodic Company Report # 8-97321-016N Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Thrombocythaemia Health Prempro PS ORAL 1 TABLET ONCE
Professional DAILY ORAL
Agrylin C
Date:
12/17/97 ISR Number: 3034640-1 Report Type: Periodic Company Report # 8-97321-017N Age:69 YR Gender: Female
I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Breast Tenderness Consumer Prempro PS ORAL 1 TABLET ONCE
Dermatitis Nos
DAILY ORAL
Provera SS
Aleve C
Calcium C
Levoxyl C
Date:
12/17/97 ISR Number: 3034642-5 Report Type: Periodic Company Report # 8-97321-018N Age:
Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Appetite Increased Nos Consumer Prempro
PS ORAL 1 TABLET ONCE
DAILY ORAL
21-Dec-2001 11:15 AM
Page: 19
FDA -
Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:
12/17/97 ISR Number: 3034644-9 Report Type: Periodic Company Report # 8-97321-019N Age:66 YR
Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Disturbance In Attention Consumer Prempro
PS ORAL 1 TABLET ONCE
Fatigue
DAILY ORAL
Lethargy
Nervousness
Date:
12/17/97 ISR Number: 3034646-2 Report Type: Periodic Company Report # 8-97321-020N Age:52 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Unevaluable Reaction Health Prempro PS ORAL 1 TABLET ONCE
Professional
DAILY ORAL
Date:
12/17/97 ISR Number: 3034648-6 Report Type: Periodic Company Report #
8-97321-021N Age: Gender: Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Withdrawal Bleeding Health Premphase PS ORAL 1 TABLET ONCE
Professional DAILY
ORAL
Company
Representative
Date:
12/17/97 ISR Number: 3034651-6 Report Type: Periodic Company Report # 8-97321-022N Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Blood Glucose
Increased Consumer Premphase PS ORAL 1 TABLET ONCE
Intermenstrual
Bleeding DAILY
ORAL
Glucotrol C
Pravachol C
Aspirin C
Date:
12/17/97 ISR Number: 3034652-8 Report Type: Periodic Company Report # 8-97321-023N Age:51 YR Gender: Female
I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Libido Decreased Health Prempro PS ORAL 1 TABLET ONCE
Professional
DAILY ORAL
Ternomin C
Date:
12/17/97 ISR Number: 3034655-3 Report Type: Periodic Company Report # 8-97321-024N Age:55 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Blood Pressure
Increased Consumer Prempro PS ORAL 1 TABLET ONCE
Headache Nos
DAILY ORAL
Lethargy
Cardizem C
Muscle Twitching
Vasotec C
Lipitor C
Lasix C
Multivitamins C
21-Dec-2001 11:15 AM Page:
20
FDA -
Adverse Event Reporting System (AERS)
Freedom Of
Information (FOI) Report
Date:
12/17/97 ISR Number: 3034656-5 Report Type: Periodic Company Report # 8-97321-025N Age:54 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Hypoaesthesia Consumer Prempro PS ORAL 1 TABLET ONCE
DAILY ORAL
Cozaar C
Prilosec C
Toprol C
Date:
12/17/97 ISR Number: 3034657-7 Report Type: Periodic Company Report # 8-97321-026N Age:68 YR Gender: Female I/FU:
I
Outcome PT Report Source Product Role
Manufacturer Route Dose Duration
Other Breast Tenderness Consumer Prempro PS ORAL 1 TABLET ONCE
DAILY
ORAL
Caltrate C
Date:
12/17/97 ISR Number: 3034660-7 Report Type: Periodic Company Report #
8-97321-027N Age:55 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Alopecia Consumer Prempro PS ORAL 1 TABLET ONCE
DAILY
ORAL
Calcium C
Multivitamin C
Date:
12/17/97 ISR Number: 3034662-0 Report Type: Periodic Company Report # 8-97321-029N Age: Gender:
Female I/FU: I
Outcome PT Report Source
Product Role Manufacturer Route
Dose Duration
Other Intermenstrual
Bleeding Health Prempro PS ORAL 1 TABLET ONCE
Professional
DAILY ORAL
Company
Representative
Date:
12/17/97 ISR Number: 3034665-6 Report Type: Periodic Company Report # 8-97321-030N Age: Gender:
Female I/FU: I
Outcome PT Report Source
Product Role Manufacturer Route
Dose Duration
Other Alopecia Consumer Prempro PS ORAL 1 TABLET ONCE
Intermenstrual
Bleeding
DAILY ORAL
Date:
12/17/97 ISR Number: 3034666-8 Report Type: Periodic Company Report #
8-97321-031N Age:75 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Rash Erythematous Consumer
Prempro PS ORAL 1 TABLET ONCE
Rash Pruritic
DAILY ORAL
Calcium C
Vitamins C
21-Dec-2001 11:15 AM
Page: 21
FDA -
Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:
12/17/97 ISR Number: 3034668-1 Report Type: Periodic Company Report # 8-97321-032N Age:47 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Myalgia Consumer Prempro
PS
ORAL 1 TABLET ONCE
DAILY ORAL
Iron C
Date:
12/17/97 ISR Number: 3034671-1 Report Type: Periodic Company Report # 8-97321-033N Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Drug Ineffective Consumer Prempro PS ORAL 1 TABLET ONCE
DAILY ORAL
Date:
12/17/97 ISR Number: 3034672-3 Report Type: Periodic Company Report # 8-97321-034N Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Uterine Haemorrhage Consumer Prempro
PS
ORAL 1 TABLET ONCE
DAILY
ORAL
Date:
12/17/97 ISR Number: 3034675-9 Report Type: Periodic Company Report # 8-97321-035N Age:62 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Breast Pain Consumer Prempro PS ORAL 1 TABLET ONCE
Dysfunctional
Uterine
DAILY ORAL
Bleeding Fosamax C
Date:
12/17/97 ISR Number: 3034677-2 Report Type: Periodic Company Report # 8-97321-036N Age:73 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Pain In Limb Consumer Prempro PS ORAL 1 TABLET ONCE
DAILY ORAL
Date:
12/17/97 ISR Number: 3034679-6 Report Type: Periodic Company Report # 8-97321-037N Age:
Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Antinuclear Factor Health Prempro PS ORAL 1 TABLET ONCE
Positive Professional DAILY
ORAL
Pruritus Nos
Rash Generalised
Date:
12/17/97 ISR Number: 3034681-4 Report Type: Periodic Company Report # 8-97321-038N Age:73 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Drug Ineffective Consumer Prempro PS ORAL 1 TABLET ONCE
DAILY ORAL
21-Dec-2001 11:15 AM
Page: 22
FDA -
Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:
12/17/97 ISR Number: 3034683-8 Report Type: Periodic Company Report # 8-97321-039N Age: Gender: Female
I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Intermenstrual
Bleeding Consumer Premphase PS ORAL 1 TABLET ONCE
DAILY ORAL
Date:
12/17/97 ISR Number: 3034684-X Report Type: Periodic Company Report # 8-97321-041N Age: Gender:
Female I/FU: I
Outcome PT Report Source Product Role
Manufacturer Route Dose Duration
Other Intermenstrual
Bleeding Health Prempro PS ORAL 1 TABLET ONCE
Vaginal
Haemorrhage Professional
DAILY ORAL
Company
Representative
Date:
12/17/97 ISR Number: 3034686-3 Report Type: Periodic Company Report # 8-97321-042N Age:68 YR Gender: Female I/FU:
I
Outcome PT Report Source Product Role
Manufacturer Route Dose Duration
Other Abdominal Distension Consumer Prempro
PS
ORAL 1 TABLET ONCE
Back Pain
DAILY ORAL
Intermenstrual
Bleeding
Menorrhagia
Muscle Cramps
Date:
12/17/97 ISR Number: 3034687-5 Report Type: Periodic Company Report # 8-97321-043N Age:68 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Alopecia Consumer Prempro PS ORAL 1 TABLET ONCE
DAILY
ORAL
Elavil C
Klonopin C
Prozac C
Synthroid C
Date:
12/17/97 ISR Number: 3034688-7 Report Type: Periodic Company Report # 8-97321-044N Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Mood Swings Consumer Premphase PS ORAL 1 TABLET ONCE
DAILY
ORAL
Date:
12/17/97 ISR Number: 3034689-9 Report Type: Periodic Company Report # 8-97321-045N Age:66 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Bone Disorder Nos Consumer
Prempro PS ORAL 1 TABLET ONCE
Drug Ineffective
DAILY ORAL
21-Dec-2001 11:15 AM
Page: 23
FDA -
Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:
12/17/97 ISR Number: 3034690-5 Report Type: Periodic Company Report # 8-97321-046N Age:50 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Vaginal Haemorrhage Consumer
Prempro PS ORAL 1 TABLET ONCE
DAILY ORAL
Date:
12/17/97 ISR Number: 3034691-7 Report Type: Periodic Company Report # 8-97321-047N Age:56 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Abdominal Distension Consumer Prempro
PS
ORAL 1 TABLET ONCE
Abdominal Pain Nos
DAILY ORAL
Intermenstrual
Bleeding
Synthroid C
Urinary Frequency
Urine Osmolarity
Increased
Date:
12/17/97 ISR Number: 3034692-9 Report Type: Periodic Company Report # 8-97321-048N Age:73 YR Gender: Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Breast Tenderness Consumer Prempro PS ORAL 1 TABLET ONCE
Intermenstrual
Bleeding
DAILY ORAL
Oophoritis
Lescol C
Date:
12/17/97 ISR Number: 3034693-0 Report Type: Periodic Company Report # 8-97321-049N Age:53 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Diarrhoea Nos Consumer Prempro PS ORAL
1 TABLET ONCE
Hot Flushes Nos
DAILY ORAL
Hunger
Sweating Increased
Date:
12/17/97 ISR Number: 3034694-2 Report Type: Periodic Company Report # 8-97322-001N Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Intermenstrual
Bleeding Health Prempro PS ORAL 1 TABLET ONCE
Professional
DAILY ORAL
Company
Representative
Date:
12/17/97 ISR Number: 3034695-4 Report Type: Periodic Company Report # 8-97322-001R Age:58 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Hirsutism Consumer Prempro PS ORAL 1 TABLET ONCE
DAILY
ORAL
21-Dec-2001 11:15 AM
Page: 24
FDA -
Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:
12/17/97 ISR Number: 3034697-8 Report Type: Periodic Company Report # 8-97322-002N Age:61 YR Gender: Female I/FU:
I
Outcome PT Report Source Product Role Manufacturer
Route Dose Duration
Other Breast Enlargement Health Prempro PS ORAL 1 TABLET ONCE
Professional
DAILY ORAL
Date:
12/17/97 ISR Number: 3034698-X Report Type: Periodic Company Report # 8-97322-002R Age:43 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Agitation Consumer Prempro
PS ORAL 1 TABLET ONCE
Feeling Hot
DAILY ORAL
Mood Swings
St.John'S Wort C
Panic Attack
Zoloft C
Progestin
Creams C
Wild Yams C
Date:
12/17/97 ISR Number: 3034700-5 Report Type: Periodic Company Report #
8-97322-003N Age: Gender: Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Hypertension Nos Health Premphase PS ORAL 1 TABLET ONCE
Professional DAILY ORAL
Date:
12/17/97 ISR Number: 3034701-7 Report Type: Periodic Company Report # 8-97322-003R Age:66 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Breast Lump Nos Consumer Prempro PS ORAL 1 TABLET ONCE
Dizziness (Excl
Vertigo)
DAILY ORAL
Aspirin C
Vitamins C
Calcium C
Fiorinal C
Date:
12/17/97 ISR Number: 3034702-9 Report Type: Periodic Company Report # 8-97322-004N Age: Gender:
Female I/FU: I
Outcome PT Report Source
Product Role Manufacturer Route
Dose Duration
Other Tachycardia Nos Consumer Prempro PS ORAL 1 TABLET ONCE
DAILY ORAL
Date:
12/17/97 ISR Number: 3034704-2 Report Type: Periodic Company Report #
8-97322-004R Age:44 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Alopecia Consumer Premphase
PS
ORAL 1 TABLET ONCE
Dermatitis Nos
DAILY ORAL
Zantac C
21-Dec-2001 11:15 AM
Page: 25
FDA -
Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:
12/17/97 ISR Number: 3034705-4 Report Type: Periodic Company Report # 8-97322-005N Age: Gender:
Female I/FU: I
Outcome PT Report Source Product Role Manufacturer
Route Dose Duration
Other Amenorrhoea Nos Consumer Prempro PS ORAL 1 TABLET ONCE
DAILY
ORAL
Date:
12/17/97 ISR Number: 3034706-6 Report Type: Periodic Company Report # 8-97322-005R Age:48 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Drug Effect Decreased Health Premphase PS ORAL 1 TABLET ONCE
Drug Interaction
Nos Professional
DAILY ORAL
Feldene C
Prozac C
Cleocin
Topical
Solution C
Date:
12/17/97 ISR Number: 3034708-X Report Type: Periodic Company Report # 8-97322-006R Age:50 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Hypersensitivity Nos Consumer Premphase
PS ORAL 1 TABLET ONCE
Vision Blurred
DAILY ORAL
Date:
12/17/97 ISR Number: 3034709-1 Report Type: Periodic Company Report # 8-97322-007N Age:66 YR Gender: Female I/FU:
I
Outcome PT Report Source Product Role Manufacturer
Route Dose Duration
Other Angioneurotic Oedema Health Prempro PS ORAL 1 TABLET ONCE
Aggravated Professional
DAILY ORAL
Blood Pressure
Increased
Oedema Lower Limb
Date: 12/17/97 ISR Number: 3034712-1 Report Type: Periodic Company Report #
8-97322-007R Age:16 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Weight Increased Health Premphase PS ORAL 1 TABLET ONCE
Professional
DAILY ORAL
Date:
12/17/97 ISR Number: 3034713-3 Report Type: Periodic Company Report # 8-97322-008N Age:44 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Abdominal Pain Nos Consumer Prempro PS ORAL 1 TABLET ONCE
Diarrhoea Nos
DAILY ORAL
Nausea
Vomiting Nos
Date:
12/17/97 ISR Number: 3034715-7 Report Type: Periodic Company Report # 8-97322-009N Age:54 YR Gender: Female I/FU:
I
Outcome PT
Other Abdominal Distension
Abdominal Pain Nos
21-Dec-2001 11:15 AM
Page: 26
FDA - Adverse
Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Breast Tenderness
Fatigue
Irritability Report Source Product Role
Manufacturer Route Dose Duration
Nausea Consumer Prempro
PS
ORAL 1 TABLET ONCE
Restlessness
DAILY ORAL
Calcitonin C
Date:
12/17/97 ISR Number: 3034716-9 Report Type: Periodic Company Report # 8-97322-010N Age:54 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Dermatitis Nos Consumer Prempro PS ORAL 1 TABLET ONCE
Intermenstrual
Bleeding
DAILY ORAL
Premarin SS ORAL 0.3MG ONCE
DAILY ORAL
Vitamins C
Date:
12/17/97 ISR Number: 3034719-4 Report Type: Periodic Company Report # 8-97322-011N Age:53 YR Gender: Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Muscle Twitching Consumer Prempro PS ORAL 1 TABLET ONCE
DAILY ORAL
Vitamins C
Vitamins C
Date:
12/17/97 ISR Number: 3034720-0 Report Type: Periodic Company Report # 8-97322-012N Age:67 YR
Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Haematuria Consumer Prempro
PS
ORAL 1 TABLET ONCE
DAILY ORAL
Date:
12/17/97 ISR Number: 3034722-4 Report Type: Periodic Company Report # 8-97322-013L Age:71 YR Gender: Female I/FU:
I
Outcome PT Report Source
Product Role Manufacturer Route
Dose Duration
Other Headache Nos Consumer Prempro PS ORAL
1 TABLET ONCE
Nausea
DAILY ORAL
Vomiting Nos Xanax C
Effexor C
Date:
12/17/97 ISR Number: 3034724-8 Report Type: Periodic Company Report # 8-97322-013N Age:55 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Abdominal Pain Nos Consumer Premphase PS ORAL 1 TABLET ONCE
Intermenstrual
Bleeding
DAILY ORAL
Date: 12/17/97 ISR Number: 3034726-1 Report Type: Periodic Company Report #
8-97322-014N Age:55 YR Gender:
Female I/FU: I
Outcome PT
Other Abdominal Pain Lower
Colitis Ischaemic
21-Dec-2001 11:15 AM
Page: 27
FDA -
Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Diarrhoea Nos
Rectal Haemorrhage
Report Source Product Role
Manufacturer Route Dose Duration
Consumer
Prempro PS ORAL 1 TABLET ONCE
DAILY ORAL
Date:
12/17/97 ISR Number: 3034727-3 Report Type: Periodic Company Report # 8-97322-015L Age:70 YR
Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Intermenstrual
Bleeding Health Prempro PS ORAL 1 TABLET ONCE
Professional DAILY ORAL
Mevacor C
Cozaar C
Tenormin C
Nitroglycerin C
Date:
12/17/97 ISR Number: 3034729-7 Report Type: Periodic Company Report #
8-97322-015N Age:60 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Breast Enlargement Consumer Prempro
PS
ORAL 1 TABLET ONCE
DAILY
ORAL
Date:
12/17/97 ISR Number: 3034731-5 Report Type: Periodic Company Report # 8-97322-016L Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Intermenstrual
Bleeding Health Prempro PS ORAL
1 TABLET ONCE
Professional
DAILY ORAL
Date:
12/17/97 ISR Number: 3034734-0 Report Type: Periodic Company Report #
8-97322-016N Age:54 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Anxiety Nec Consumer Prempro PS ORAL 1 TABLET ONCE
Faecal Abnormality
Nos
DAILY ORAL
Irritability
Paraesthesia
Weight Decreased
Date:
12/17/97 ISR Number: 3034735-2 Report Type: Periodic Company Report # 8-97322-017L Age:63 YR
Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Haemorrhage Nos Consumer Prempro PS ORAL TABLET ONCE
DAILY ORAL 6
MON
Date:
12/17/97 ISR Number: 3034737-6 Report Type: Periodic Company Report # 8-97322-017N Age:55 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Vaginal Haemorrhage Health Prempro PS ORAL
TABLET ONCE
Professional
DAILY ORAL
21-Dec-2001 11:15 AM Page:
28
FDA -
Adverse Event Reporting System (AERS)
Freedom Of Information
(FOI) Report
Date:
12/17/97 ISR Number: 3034739-X Report Type: Periodic Company Report # 8-97322-018N Age:50 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Depression Aggravated Health Prempro PS ORAL TABLET ONCE
Professional
DAILY ORAL
Imipramine C
Buspar C
Date:
12/17/97 ISR Number: 3034741-8 Report Type: Periodic Company Report # 8-97322-019L Age: Gender: Female
I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Weight Increased Consumer Prempro PS ORAL 1 TABLET ONCE
DAILY ORAL
Date:
12/17/97 ISR Number: 3034743-1 Report Type: Periodic Company Report # 8-97322-019N Age:70 YR Gender: Female I/FU:
I
Outcome PT Report Source Product Role
Manufacturer Route Dose Duration
Other Drug Ineffective Health Prempro PS ORAL 1 TABLET ONCE
Professional
DAILY ORAL
Company
Fosamax SS
Representative
Date:
12/17/97 ISR Number: 3034744-3 Report Type: Periodic Company Report # 8-97322-020N Age:56 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Intermenstrual
Bleeding Consumer Prempro PS ORAL 1 TABLET ONCE
DAILY ORAL
Flaxid Oil C
Trace Mineral C
Date:
12/17/97 ISR Number: 3034746-7 Report Type: Periodic Company Report # 8-97322-021L Age: Gender: I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Intermenstrual
Bleeding Health Prempro
PS
ORAL 1 TABLET ONCE
Professional
DAILY ORAL
Date:
12/17/97 ISR Number: 3034749-2
Report Type: Periodic
Company Report # 8-97322-021N
Age:50 YR Gender: Female
I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Abdominal Pain Lower Health Prempro PS ORAL 1 TABLET ONCE
Intermenstrual Bleeding Professional
DAILY ORAL
Date:
12/17/97 ISR Number: 3034750-9 Report Type: Periodic Company Report # 8-97322-022N Age:65 YR Gender: Female I/FU:
I
Outcome PT
Other Abnormal Dreams
Feeling Jittery
Genital Pruritus
Female
Phlebitis Nos
21-Dec-2001 11:15 AM Page:
29
FDA -
Adverse Event Reporting System (AERS)
Freedom Of Information
(FOI) Report
Tenderness Nos
Vaginal Discharge
Report Source
Product Role
Manufacturer Route Dose Duration
Consumer
Prempro PS ORAL 1 TABLET ONCE
DAILY
ORAL
Inderal C
Date:
12/17/97 ISR Number: 3034752-2 Report Type: Periodic Company Report #
8-97322-023L Age: Gender: Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Diplopia Consumer Prempro PS ORAL 1 TABLET ONCE
Dizziness (Excl
Vertigo) DAILY
ORAL
Myasthenia Gravis
Nausea
Date:
12/17/97 ISR Number: 3034753-4 Report Type: Periodic Company Report #
8-97322-024L Age:48 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Blood Triglycerides Consumer
Premphase PS ORAL 1 TABLET ONCE
Increased
DAILY
ORAL
Date:
12/17/97 ISR Number: 3034754-6 Report Type: Periodic Company Report # 8-97322-025L Age:65 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Weight Decreased Consumer Prempro PS ORAL 1 TABLET ONCE
Weight Increased
DAILY ORAL
Persantine C
Synthroid C
Date:
12/17/97 ISR Number: 3034757-1 Report Type: Periodic Company Report # 8-97322-026L Age:51 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Dizziness (Excl
Vertigo) Consumer Prempro
PS
ORAL 1 TABLET ONCE
Motion Sickness
DAILY ORAL
Cardizem
Cd C
Lopressor C
Date:
12/17/97 ISR Number: 3034759-5 Report Type: Periodic Company Report # 8-97322-027L Age:58 YR
Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Intermenstrual
Bleeding Consumer Prempro PS ORAL TABLET ONCE
DAILY ORAL
Synthroid C
Monopril C
Aspirin C
21-Dec-2001 11:15 AM
Page: 30
FDA -
Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:
12/17/97 ISR Number: 3034761-3 Report Type: Periodic Company Report #
8-97323-001N Age:40 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Intermenstrual
Bleeding Health Prempro PS ORAL 1 TABLET ONCE
Professional
DAILY ORAL
Unspecified Allergy
Medications C
Date:
12/17/97 ISR Number: 3034762-5 Report Type: Periodic Company Report # 8-97323-001R Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Intermenstrual
Bleeding Health Prempro PS ORAL 1 TABLET ONCE
Professional
DAILY ORAL
Company
Representative
Date:
12/17/97 ISR Number: 3034767-4 Report Type: Periodic Company Report # 8-97323-002N Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Vaginal Haemorrhage Consumer Prempro
PS
ORAL 1TABLET ONCE
DAILY ORAL
Premarin SS ORAL ORAL
Date:
12/17/97 ISR Number: 3034769-8 Report Type: Periodic Company Report # 8-97323-002R Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Nausea Health Prempro PS ORAL 1 TABLET ONCE
Professional
DAILY ORAL
Company
Representative
Date:
12/17/97 ISR Number: 3046076-8 Report Type: Periodic Company Report # 8-97269-002R Age:57 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Allergy To Insect Sting Health Prempro PS ORAL TABLET ONCE
Initial or
Prolonged Hypotension Nos Professional
DAILY ORAL
Pruritus Nos Glucophage C
Pulse Absent
Amantadine C
Urticaria Nos
Multi-Vitamin C
B12 Injection C
Date:
12/17/97 ISR Number: 3046080-X Report Type: Periodic Company Report # 8-97283-001R Age:60 YR Gender: Female I/FU:
I
Outcome PT
Report Source
Product Role Manufacturer Route
Dose Duration
Hospitalization
- Gallbladder Disorder Nos Consumer Prempro
PS ORAL 1 TABLET ONCE
Initial or
Prolonged Polymenorrhoea
DAILY ORAL
21-Dec-2001 11:15 AM Page:
31
FDA -
Adverse Event Reporting System (AERS)
Freedom Of
Information (FOI) Report
Date:
12/17/97 ISR Number: 3046084-7 Report Type: Periodic Company Report # 8-97302-003R Age:68 YR Gender: Female I/FU:
I
Outcome PT
Report Source
Product Role Manufacturer Route
Dose Duration
Hospitalization
- Alopecia Consumer Prempro PS ORAL
1 TABLE ONCE
Initial or
Prolonged Phlebitis Nos
DAILY ORAL
Venous Thrombosis
Deep Coumadin C
Limb
Date:
12/17/97 ISR Number: 3046086-0 Report Type: Periodic Company Report # 8-97316-008R Age: Gender:
Female I/FU: I
Outcome PT
Report Source
Product Role Manufacturer Route
Dose Duration
Hospitalization
- Pancreatitis Nos Health Prempro PS ` ORAL
1 TABLET ONCE
Initial or
Prolonged
Professional
DAILY ORAL
Company Biaxin C
Representative
Date:
12/17/97 ISR Number: 3046089-6 Report Type: Periodic Company Report # 8-97234-003R Age:53 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Fluid Retention Health Prempro
PS
ORAL 1 TABLET ONCE
Hot Flushes Nos Professional
DAILY ORAL
Oedema Lower Limb
Pain In Limb
Date:
12/17/97 ISR Number: 3046094-X Report Type: Periodic Company Report # 8-97238-001R Age:66 YR Gender:
I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Abdominal Pain Upper Consumer Prempro
PS ORAL 1 TABLET ONCE
Difficulty In
Walking
DAILY ORAL
Date:
12/17/97 ISR Number: 3046097-5 Report Type: Periodic Company Report #
8-97241-011R Age:55 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Alopecia Consumer Premphase PS ORAL 1 TABLET ONCE
Yellow Skin DAILY ORAL
Date:
12/17/97 ISR Number: 3046098-7 Report Type: Periodic Company Report # 8-97247-003R Age:66 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Dysmenorrhoea Consumer Prempro PS ORAL 1 TABLET
ONCE
Dyspnoea Nos
DAILY ORAL
Intermenstrual
Bleeding
Pain In Limb
Date:
12/17/97 ISR Number: 3046100-2 Report Type: Periodic Company Report # 8-97247-005R Age: Gender:
I/FU: I
Outcome PT Report Source Product Role Manufacturer
Route Dose Duration
Other Cervical Polyp Consumer Prempro PS ORAL ORAL
8 MON
21-Dec-2001 11:15 AM
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FDA -
Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:
12/17/97 ISR Number: 3046111-7 Report Type: Periodic Company Report # 8-97247-006R Age:70 YR Gender: Female
I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Intermenstrual
Bleeding Consumer Prempro PS ORAL 1 TABLET ONCE
Vaginal
Haemorrhage
DAILY ORAL
Posamax C
Vitamins C
Date:
12/17/97 ISR Number: 3046113-0 Report Type: Periodic Company Report #
8-97247-007R Age:69 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Candidal Infection Nos Consumer Prempro
PS
ORAL 1 TABLET ONCE
DAILY ORAL
Cardizem C
Mevacor C
Synthroid C
Date:
12/17/97 ISR Number: 3046116-6 Report Type: Periodic Company Report # 8-97247-009R Age: Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Alopecia Consumer Prempro
PS
ORAL 1 TABLET ONCE
Vision Blurred
DAILY ORAL 2 YR
Date:
12/17/97 ISR Number: 3046136-1 Report Type: Periodic Company Report # 8-97247-010R Age: Gender:
I/FU: I
Outcome PT Report Source Product
Role Manufacturer
Route Dose Duration
Other Breast Enlargement Health Prempro PS ORAL 1 TABLET ONCE
Breast Tenderness Professional
DAILY ORAL
Date:
12/17/97 ISR Number: 3046140-3 Report Type: Periodic Company Report # 8-97276-002R Age: Gender:
I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Libido Decreased Consumer Prempro PS ORAL 1 TABLET ONCE
Weight Decreased
DAILY ORAL
Date:
12/17/97 ISR Number: 3046143-9 Report Type: Periodic Company Report # 8-97283-002R Age:60 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Tremor Consumer Premphase PS ORAL 1 TABLET ONCE
Weakness
DAILY ORAL
Date:
12/17/97 ISR Number: 3046146-4 Report Type: Periodic Company Report # 8-97295-001R Age:45 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Muscle Cramps Consumer Premphase PS ORAL 1 TABLET ONCE
Muscle Twitching
DAILY ORAL
Trazodone C
Acyclovir C
21-Dec-2001 11:15 AM Page:
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FDA -
Adverse Event Reporting System (AERS)
Freedom Of
Information (FOI) Report
Date:
12/17/97 ISR Number: 3046147-6 Report Type: Periodic Company Report # 8-97295-002R Age:47 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Rheumatoid Arthritis Health Prempro PS ORAL 1
TABLET ONCE
Aggravated Professional
DAILY ORAL 30 DAY
Methotrexate Weekly
Injections C
Prednisone C
Date: 12/17/97 ISR Number: 3046150-6 Report Type: Periodic Company Report #
8-97295-003R Age:51 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Alopecia Consumer Prempro PS ORAL 1 TABLET ONCE
Dizziness (Excl Vertigo)
DAILY ORAL
Dysmenorrhoea
Date:
12/17/97 ISR Number: 3046187-7 Report Type: Periodic Company Report # 8-97295-004R Age:52 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Breast Enlargement Health Prempro PS ORAL 1 TABLET ONCE
Breast Tenderness Professional DAILY ORAL
Pruritus Nos
Several Inhalers C
Theophylline C
Date:
12/17/97 ISR Number: 3046189-0 Report Type: Periodic Company Report #
8-97295-005R Age: Gender: Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Urinary Incontinence Consumer Prempro
PS
ORAL 1 TABLET ONCE
DAILY
ORAL
Date:
12/17/97 ISR Number: 3046191-9 Report Type: Periodic Company Report # 8-97295-006R Age:60 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Acne Nos Consumer Prempro 14/14 PS
ORAL TABLET ONCE
DAILY ORAL
Otc
Anthistamine/Deconge
stants C
Date:
12/17/97 ISR Number: 3046193-2 Report Type: Periodic Company Report #
8-97295-007R Age:45 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Menorrhagia Consumer Premphase 14/14 PS ORAL 1 TABLET ONCE
DAILY
ORAL
21-Dec-2001 11:15 AM
Page: 34
FDA -
Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date: 12/17/97 ISR Number: 3046194-4 Report Type: Periodic Company Report #
8-97295-008R Age:52 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Abdominal Distension Consumer Prempro
PS
ORAL 1 TABLET ONCE
Abdominal Pain Nos
DAILY ORAL
Amenorrhoea Nos
Intermenstrual
Bleeding
Menorrhagia
Date:
12/17/97 ISR Number: 3046197-X
Report Type: Periodic
Company Report # 8-97296-002R
Age:75 YR Gender: Female
I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Breast Pain Consumer Prempro 14/14 PS ORAL 1 TABLET ONCE
Intermenstrual
Bleeding
DAILY ORAL
Lipitor C
Date:
12/17/97 ISR Number: 3046198-1 Report Type: Periodic Company Report #
8-97296-003R Age:45 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Abdominal Pain Lower Consumer Prempro
PS
ORAL 1 TABLET ONCE
Menorrhagia DAILY
ORAL
Date:
12/17/97 ISR Number: 3046200-7 Report Type: Periodic Company Report # 8-97296-004R Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Dermatitis Nos Consumer Prempro PS ORAL 1 TABLET ONCE
Photosensitivity
Reaction
DAILY ORAL
Nos Multivitamins C
Date:
12/17/97 ISR Number: 3046203-2 Report Type: Periodic Company Report # 8-97297-001R Age:47 YR Gender: Female I/FU:
I
Outcome PT Report Source
Product Role Manufacturer Route
Dose Duration
Other Blood Prolactin
Increased Health Prempro PS ORAL
1 TABLET ONCE
Professional
DAILY ORAL
Atenolol C
Lescol C
Claritin Prn C
Date:
12/17/97 ISR Number: 3046205-6 Report Type: Periodic Company Report #
8-97297-002R Age:54 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Migraine Aggravated Consumer Prempro
PS
ORAL 1 TABLET ONCE
Vision Blurred DAILY
ORAL
Fosamax C
21-Dec-2001 11:15 AM Page:
35
FDA -
Adverse Event Reporting System (AERS)
Freedom Of
Information (FOI) Report
Date:
12/17/97 ISR Number: 3046207-X Report Type: Periodic Company Report # 8-97297-003R Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Genital Pruritus
Female Consumer Prempro PS ORAL 1
TABLET ONCE
DAILY ORAL
Date:
12/17/97 ISR Number: 3046210-X Report Type: Periodic Company Report #
8-97297-004R Age: Gender: I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Drug Hypersensitivity Health Premphase PS ORAL 1 TABLET ONCE
Professional
DAILY ORAL
Company
Representative
Date:
12/17/97 ISR Number: 3046212-3 Report Type: Periodic Company Report #
8-97297-005R Age:52 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Drug Ineffective Health Prempro PS ORAL 1 TABLET ONCE
Professional
DAILY ORAL
Date:
12/17/97 ISR Number: 3046214-7 Report Type: Periodic Company Report # 8-97300-001R Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Drug Ineffective Health Prempro PS
ORAL 1 TABLET ONCE
Professional
DAILY ORAL
Date:
12/17/97 ISR Number: 3046216-0 Report Type: Periodic Company Report #
8-97300-002R Age:59 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Breast Tenderness Health Prempro PS ORAL 1 TABLET ONCE
Fluid Retention Professional DAILY ORAL
Intermenstrual
Bleeding
Antihypertensives C
Irritability
Date:
12/17/97 ISR Number: 3046217-2 Report Type: Periodic Company Report #
8-97300-003R Age:53 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Asthma Aggravated Consumer Prempro PS ORAL 1 TABLET ONCE
Breast Pain
DAILY
ORAL
Night Sweats
Accolate C
Theo-Dur C
Aerobid C
Proventil Inhaler C
Lorazepam C
21-Dec-2001 11:15 AM
Page: 36
FDA - Adverse Event
Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:
12/17/97 ISR Number: 3046218-4 Report Type: Periodic Company Report #
8-97300-004R Age:53 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Back Pain Consumer Prempro PS ORAL 1 TABLET ONCE
Haemorrhage Nos
DAILY ORAL
Date:
12/17/97 ISR Number: 3046219-6 Report Type: Periodic Company Report # 8-97300-006R Age:53 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Hypoglycaemia Nos Consumer Prempro 14/14 PS ORAL 1
TABLET ONCE
DAILY ORAL
Zestril C
Date:
12/17/97 ISR Number: 3046220-2 Report Type: Periodic Company Report # 8-97300-007R Age:65 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Menometrorrhagia Health Prempro Tablets PS
ORAL 1 TABLET ONCE
Professional
DAILY ORAL
Company
Representative
Date:
12/17/97 ISR Number: 3046222-6 Report Type: Periodic Company Report # 8-97300-008R Age:67 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Haemorrhage Nos Consumer Prempro PS ORAL 1 TABLET ONCE
Pain In Limb
DAILY ORAL
Vitamins C
Date:
12/17/97 ISR Number: 3046223-8 Report Type: Periodic Company Report # 8-97301-001R Age:80 YR Gender: Female I/FU:
I
Outcome PT Report Source Product Role Manufacturer
Route Dose Duration
Other Breast Pain Consumer Prempro PS ORAL 1 TABLET ONCE
Intermenstrual Bleeding
DAILY ORAL
Atenol C
Paxil C
Calcium Supplement C
Vitamin D And
Multi-Vitamin C
Date:
12/17/97 ISR Number: 3046224-X Report Type: Periodic Company Report # 8-97301-002R Age: Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Intermenstrual
Bleeding Health Prempro 14/14
PS
ORAL 1 TABLET ONCE
Irritability Professional
DAILY ORAL
21-Dec-2001 11:15 AM
Page: 37
FDA -
Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:
12/17/97 ISR Number: 3046225-1 Report Type: Periodic Company Report # 8-97301-003R Age: Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Hirsutism Consumer Prempro
PS
ORAL 1 TABLET ONCE
DAILY ORAL
Depakote C
Date:
12/17/97 ISR Number: 3046226-3 Report Type: Periodic Company Report # 8-97301-004R Age:64 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Migraine Nos Consumer Prempro PS ORAL 1 TABLET ONCE
Visual Disturbance
Nos
DAILY ORAL
Blood Pressure
Medication
(Unspecified) C
Date:
12/17/97 ISR Number: 3046464-X Report Type: Periodic Company Report #
8-97301-007R Age:59 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Breast Pain Consumer Prempro PS ORAL 1 TABLET ONCE
Headache Nos DAILY ORAL
Muscle Spasms
Fosamax C
Photopsia
Visual Acuity Reduced
Date:
12/17/97 ISR Number: 3046469-9 Report Type: Periodic Company Report # 8-97303-002R Age:51 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Chloasma Consumer Prempro PS ORAL 1 TABLET ONCE
DAILY ORAL
Claritin C
Atrovent C
Date:
12/17/97 ISR Number: 3046472-9 Report Type: Periodic Company Report # 8-97303-003R Age:71 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Blood Glucose
Increased Consumer Prempro PS ORAL 1 TABLET ONCE
DAILY ORAL
Tenormin C
Pravachol C
Date:
12/17/97 ISR Number: 3046474-2 Report Type: Periodic Company Report #
8-97303-004R Age:82 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Breast Engorgement Consumer
Prempro PS ORAL 1 TABLET ONCE
DAILY ORAL
21-Dec-2001 11:15 AM
Page: 38
FDA - Adverse
Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:
12/17/97 ISR Number: 3046479-1 Report Type: Periodic Company Report # 8-97307-004R
Age:53 YR Gender: Female
I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Asthma Aggravated Consumer
Premphase PS ORAL 1 TABLET ONCE
DAILY ORAL
Accolate C
Theodur C
Aerobid
Inhaler C
Proventil Inhaler C
Lorazepam C
Date:
12/17/97 ISR Number: 3046481-X Report Type: Periodic Company Report # 8-97311-001R Age:57 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Breast Disorder Nos Consumer Prempro
PS
ORAL 1 TABLET ONCE
Feeling Hot
DAILY ORAL
Antibiotic
(Unspecified) C
Date:
12/17/97 ISR Number: 3046483-3 Report Type: Periodic Company Report # 8-97314-001R Age:50 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Intermenstrual
Bleeding Consumer Prempro PS
ORAL 1 TABLET ONCE
DAILY ORAL
Synthroid C
Date:
12/17/97 ISR Number: 3046486-9 Report Type: Periodic Company Report # 8-97314-003R Age:72 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Breast Atrophy
Prempro PS ORAL 1
TABLET ONCE
Loss Of Libido
DAILY ORAL
Date:
12/17/97 ISR Number: 3046489-4 Report Type: Periodic Company Report #
8-97314-005R Age: Gender: Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Intermenstrual
Bleeding Consumer Prempro PS ORAL 1 TABLET ONCE
Menorrhagia
DAILY ORAL
Date:
12/17/97 ISR Number: 3046492-4 Report Type: Periodic Company Report # 8-97314-006R Age:59 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Dizziness (Excl
Vertigo) Consumer Prempro PS ORAL 1
TABLET ONCE
Nausea
DAILY ORAL
Pain In Limb
Vein Disorder Nos
21-Dec-2001 11:15 AM
Page: 39
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:
12/17/97 ISR Number: 3046495-X Report Type: Periodic Company Report # 8-97315-002R Age:62 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Alopecia Consumer Prempro
PS ORAL 1 TABLET ONCE
DAILY ORAL
Inhaler
(Unspecified) C
Gamma
Globulin
Monthly Infusion C
Date:
12/17/97 ISR Number: 3046498-5 Report Type: Periodic Company Report # 8-97315-003R Age:47 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Intermenstrual Bleeding Consumer Prempro
PS ORAL 1 TABLET ONCE
DAILY ORAL
Date:
12/17/97 ISR Number: 3046500-0 Report Type: Periodic Company Report # 8-97315-006R Age: Gender:
Female I/FU: I
Outcome PT Report Source Product Role
Manufacturer Route Dose Duration
Other Colitis Ischaemic Health Prempro PS ORAL 1 TABLET ONCE
Professional
DAILY ORAL
Date:
12/17/97 ISR Number: 3046502-4 Report Type: Periodic Company Report # 8-97315-007R Age:63 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Alopecia Consumer
Prempro PS ORAL 1 TABLET ONCE
DAILY ORAL
Date:
12/17/97 ISR Number: 3046504-8 Report Type: Periodic Company Report # 8-97315-008R Age:65 YR Gender: Female I/FU:
I
Outcome PT Report Source Product Role
Manufacturer Route Dose Duration
Other Acne Nos Consumer Prempro PS ORAL 1 TABLET ONCE
Intermenstrual Bleeding
DAILY ORAL
Menorrhagia
Date:
12/17/97 ISR Number: 3046507-3 Report Type: Periodic Company Report #
8-97316-001R Age:54 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Vision Blurred Consumer Prempro
PS
ORAL 1 TABLET ONCE
DAILY ORAL
Fosamax SS
UNKNOWN
Lopressor C
Multi-Vitamin C
Date:
12/17/97 ISR Number: 3046509-7 Report Type: Periodic Company Report # 8-97316-002R Age:65 YR Gender: Female
I/FU: I
Outcome PT
Other Muscle Cramps
Oedema Lower Limb
21-Dec-2001 11:15 AM
Page: 40
FDA -
Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Pain In Limb
Rash Erythematous
Report Source
Product Role Manufacturer Route
Dose Duration
Consumer
Prempro PS ORAL 1 TABLET ONCE
DAILY ORAL
Digoxin C
Spironolactone C
Furosemide C
Vitamin D, B, E, C C
Aspirin C
Date:
12/17/97 ISR Number: 3046512-7 Report Type: Periodic Company Report # 8-97316-003N Age:62 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Depressed Mood Consumer Prempro PS ORAL 1 TABLET ONCE
Fatigue
DAILY ORAL
Headache Nos Maxzide C
Weakness
Vasotec C
Verelan C
Zoloft C
Date:
12/17/97 ISR Number: 3046517-6 Report Type: Periodic Company Report # 8-97316-003R Age: Gender:
Female I/FU: I
Outcome PT
Report Source
Product Role Manufacturer Route
Dose Duration
Other Bleeding Tendency Health Prempro 14/14 PS ORAL 1 TABLET ONCE
Ecchymosis Professional
DAILY ORAL
Date:
12/17/97 ISR Number: 3046520-6 Report Type: Periodic Company Report #
8-97316-004N Age:60 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Abdominal Distension Consumer Prempro 14/14
PS
ORAL 1 TABLET
Breast Tenderness ONCE DAILY
ORAL
Vitamins C
Date:
12/17/97 ISR Number: 3046523-1 Report Type: Periodic Company Report # 8-97316-004R Age:66 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Headache Nos Health Prempro 14/14 PS ORAL 1 TABLET
ONCE
Professional
DAILY ORAL
Cardizem C
Synthroid C
Date:
12/17/97 ISR Number: 3046526-7 Report Type: Periodic Company Report # 8-97316-005N Age:68 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Breast Tenderness Consumer Prempro 14/14 PS ORAL 1 TABLET ONCE
Intermenstrual
Bleeding
DAILY ORAL
21-Dec-2001 11:15 AM
Page: 41
FDA -
Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:
12/17/97 ISR Number: 3046529-2 Report Type: Periodic Company Report # 8-97316-005R Age:61 YR Gender: Female
I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Breast Enlargement Consumer Prempro
PS
ORAL 1 TABLET ONCE
Irritability
DAILY ORAL
Nervousness Vitamins 1 Daily C
Date:
12/17/97 ISR Number: 3046532-2 Report Type: Periodic Company Report # 8-97316-006N Age:52 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Hoarseness Consumer Premphase PS ORAL 1 TABLET ONCE
DAILY ORAL
Premarin SS ORAL
0.625 MG IN
PM ORAL
Paxil C
Date:
12/17/97 ISR Number: 3046534-6 Report Type: Periodic Company Report # 8-97316-006R Age:59 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Vaginal Candidiasis Consumer Prempro PS ORAL 1 TABLET ONCE
DAILY ORAL
Tenex C
Bumex C
Date:
12/17/97 ISR Number: 3046537-1 Report Type: Periodic Company Report #
8-97316-007R Age:53 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Eye Disorder Nos Health Prempro PS ORAL 1 TABLET ONCE
Professional
DAILY ORAL
Date:
12/17/97 ISR Number: 3046540-1 Report Type: Periodic Company Report # 8-97316-008N Age:63 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Alopecia Consumer Prempro 14/14 PS ORAL 1
TABLET ONCE
Hair Texture
Abnormal
DAILY ORAL
Synthroid C
Date:
12/17/97 ISR Number: 3046542-5 Report Type: Periodic Company Report # 8-97316-012R Age:66 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Headache Nos Consumer Prempro 14/14 PS ORAL 1 TABLET ONCE
Hypersensitivity
Nos
DAILY ORAL
Pruritus Nos One A
Day Vitamin
Daily C
21-Dec-2001 11:15 AM
Page: 42
FDA -
Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:
12/17/97 ISR Number: 3046545-0 Report Type: Periodic Company Report #
8-97317-003N Age:63 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route
Dose Duration
Other Leg Ulcer (Excl
Varicose) Consumer Prempro PS ORAL 1 TABLET ONCE
DAILY
ORAL
Date:
12/17/97 ISR Number: 3046549-8 Report Type: Periodic Company Report # 8-97317-004R Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Uterine Fibroids Consumer Prempro 14/14 PS ORAL 1 TABLET ONCE
DAILY ORAL
Date:
12/17/97 ISR Number: 3046550-4 Report Type: Periodic Company Report #
8-97317-005N Age:50 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route
Dose Duration
Other Nausea Consumer Prempro PS ORAL 1 TABLET ONCE
Unexpected
Therapeutic DAILY
ORAL
Drug Effect
Xanax C
Weight Decreased Zoloft C
Date:
12/17/97 ISR Number: 3046553-X Report Type: Periodic Company Report # 8-97317-005R Age: Gender:
Female I/FU: I
Outcome PT Report Source
Product Role Manufacturer Route
Dose Duration
Other Breast Tenderness Consumer Prempro PS ORAL 1 TABLET ONCE
DAILY ORAL 2 WK
Date:
12/17/97 ISR Number: 3046556-5 Report Type: Periodic Company Report # 8-971317-006N Age:57 YR
Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Crying Consumer Prempro PS ORAL 1 TABLET ONCE
Extrasystoles Nos DAILY
ORAL
Serzone SS
Fosamax C
Date:
12/17/97 ISR Number: 3046559-0 Report Type: Periodic Company Report # 8-97317-007N Age:52 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer
Route Dose Duration
Other Abdominal Distension Consumer Prempro
PS
ORAL 1 TABLET ONCE
DAILY
ORAL
Date:
12/17/97 ISR Number: 3046562-0 Report Type: Periodic Company Report # 8-97317-008N Age:50 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Asthma Aggravated Consumer Prempro PS ORAL 1 TABLET ONCE
Drug Ineffective
DAILY ORAL
Dyspnoea Nos
21-Dec-2001 11:15 AM
Page: 43
FDA - Adverse Event
Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:
12/17/97 ISR Number: 3046565-6 Report Type: Periodic Company Report #
8-97317-009N Age:54 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Breast Pain Consumer Premphase PS ORAL 1 TABLET ONCE
Breast Tenderness
DAILY ORAL
Zantac C
Date:
12/17/97 ISR Number: 3046569-3 Report Type: Periodic Company Report # 8-97317-010N Age:
Gender: Female
I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Skin Discolouration Health Prempro PS ORAL 1 TABLET ONCE
Professional
DAILY ORAL
Date:
12/17/97 ISR Number: 3046575-9 Report Type: Periodic Company Report # 8-97317-011N Age:67 YR Gender: Female I/FU:
I
Outcome PT Report Source Product Role
Manufacturer Route Dose Duration
Vaginal
Haemorrhage Consumer Premphase PS ORAL 1 TABLET ONCE
DAILY
ORALL
Cordarone C
Coumadin C
Cozaar C
Zocor C
Date:
12/17/97 ISR Number: 3046633-9 Report Type: Periodic Company Report # 8-97317-012N Age:64 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Alopecia Health Prempro PS ORAL 1 TABLET ONCE
Professional
DAILY; ORAL
Date:
12/17/97 ISR Number: 3046637-6 Report Type: Periodic Company Report # 8-97317-013N Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Haemorrhage Nos Health Prempro PS ORAL 1 TABLET ONCE
Professional
DAILY; ORAL
Date:
12/17/97 ISR Number: 3046640-6 Report Type: Periodic Company Report # 8-97317-014N Age:52 YR Gender: Female I/FU:
I
Outcome PT Report Source Product Role Manufacturer
Route Dose Duration
Other Anger Consumer Prempro PS ORAL 1 TABLET ONCE
Breast Tenderness
DAILY; ORAL
Discomfort Nos
Amitriptyline C
Dyspnoea Nos Bactrim C
Nausea
Psychotic Disorder Nos
21-Dec-2001 11:15 AM Page:
44
FDA -
Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:
12/17/97 ISR Number: 3049814-3 Report Type: Periodic Company Report # 8-97323-003R Age: Gender:
Female I/FU: I
Outcome PT Report Source
Product Role Manufacturer Route
Dose Duration
Other Breast Tenderness Health Prempro PS ORAL 1 TABLET ONCE
Professional
DAILY ORAL
Company
Representative
Date:
12/17/97 ISR Number: 3049816-7 Report Type: Periodic Company Report # 8-97323-004N Age:62 YR Gender: Female I/FU:
I
Outcome PT Report Source
Product Role Manufacturer Route
Dose Duration
Other Ecchymosis Consumer Prempro PS ORAL 1 TABLET ONCE
DAILY ORAL
Topril C
Date:
12/17/97 ISR Number: 3049817-9 Report Type: Periodic Company Report # 8-97323-004R Age:66 YR Gender: Female I/FU:
I
Outcome PT Report Source Product Role Manufacturer
Route Dose Duration
Other Muscle Cramps Consumer Prempro PS ORAL 1 TABLET ONCE
DAILY
ORAL
Date:
12/17/97 ISR Number: 3049820-9 Report Type: Periodic Company Report # 8-97323-005N Age:62 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Abdominal Pain Nos Consumer Prempro
PS ORAL 1 TABLET ONCE
DAILY ORAL
CONTINUES
Capoten C
Insulin C
Date:
12/17/97 ISR Number: 3049824-6 Report Type: Periodic Company Report # 8-97323-005R Age:51 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Abdominal Distension Consumer Prempro PS ORAL 1 TABLET ONCE
Breast Pain
DAILY ORAL
Flatulence
CONTINUES
Vitamins And Mineral
Supplements C
Date:
12/17/97 ISR Number: 3049825-8 Report Type: Periodic Company Report # 8-97323-006N Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Condition Aggravated Consumer Prempro
PS ORAL 1 TABLET ONCE
Generalised
Anxiety
DAILY ORAL
Disorder Xanax C
Zestril C
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Date:
12/17/97 ISR Number: 3049828-3 Report Type: Periodic Company Report # 8-97323-006R Age:68 YR Gender: Female I/FU:
I
Outcome PT Report Source Product Role Manufacturer
Route Dose Duration
Other Intermenstrual
Bleeding Consumer Prempro PS ORAL 1 TABLET ONCE
DAILY
ORAL
Synthroid C
Amiloride C
Ziac C
Date:
12/17/97 ISR Number: 3049831-3 Report Type: Periodic Company Report #
8-97323-007N Age:78 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Abdominal Distension Consumer Prempro
PS
ORAL 1 TABLET ONCE
Appetite Increased
Nos
DAILY ORAL
Breast
Enlargement
CONTINUES
Breast Tenderness
Calcium C
Intermenstrual
Bleeding
Fosamax C
Weight Increased Xanax C
Date:
12/17/97 ISR Number: 3049833-7 Report Type: Periodic Company Report # 8-97323-009N Age:50 YR Gender: Female I/FU:
I
Outcome PT Report Source Product Role Manufacturer
Route Dose Duration
Other Condition Aggravated Consumer Premphase
PS
ORAL 1 TABLET ONCE
Muscle Spasms
DAILY ORAL
Pain In Limb
Rash Generalised
Rash Maculo-Papular
Vascular Skin Condition
Nos
Date:
12/17/97 ISR Number: 3049837-4 Report Type: Periodic Company Report # 8-97323-010N Age:55 YR Gender: Female I/FU:
I
Outcome PT
Report Source
Product Role Manufacturer Route
Dose Duration
Other Migraine Nos Consumer Prempro PS ORAL
1 TABLET ONCE
Vaginal
Haemorrhage
DAILY ORAL
Lescol C
Synthroid C
Date:
12/17/97 ISR Number: 3049841-6 Report Type: Periodic Company Report # 8-97051-019N Age:72 YR Gender: Female I/FU:
F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Menorrhagia Consumer Prempro
PS ORAL 1 TABLET ONCE
DAILY ORAL
Date:
12/17/97 ISR Number: 3049843-X Report Type: Periodic Company Report # 8-97134-007R Age:56 YR Gender: Female I/FU:
F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Auricular Swelling Health Prempro PS ORAL 1 TABLET ONCE
Hypoaesthesia Professional
DAILY ORAL
Rash Generalised Solaquin
Forte C
Vision Blurred Zantac C
21-Dec-2001 11:15 AM
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Clonidine C
Allegra C
Date:
12/17/97 ISR Number: 3049846-5 Report Type: Periodic Company Report #
8-97134-011R Age:49 YR Gender:
Female I/FU: F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Intermenstrual
Bleeding Health Prempro PS ORAL 1 TABLET ONCE
Urticaria Nos Professional DAILY ORAL
Monopril C
Unspecified Water
Pill C
Date:
12/17/97 ISR Number: 3049848-9 Report Type: Periodic Company Report # 8-97136-001R Age:66 YR Gender: Female I/FU:
F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Abdominal Mass Nos Consumer Prempro
PS ORAL 1 TABLET ONCE
Abdominal Pain
Lower
DAILY ORAL
Dysuria
Nausea
Urinary Frequency
Date:
12/17/97 ISR Number: 3049850-7 Report Type: Periodic Company Report # 8-97171-006N Age:56 YR Gender: Female I/FU:
F
Outcome PT Report Source
Product Role Manufacturer Route
Dose Duration
Other Polymenorrhoea Health Prempro PS ORAL 1 TABLET ONCE
Professional
DAILY ORAL
Daypro C
Aspirin C
Vitamin Supplements C
Date:
12/17/97 ISR Number: 3049854-4 Report Type: Periodic Company Report #
8-97175-004R Age:69 YR Gender:
Female I/FU: F
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Benign Breast Neoplasm Consumer Prempro
PS
ORAL 1 TABLET ONCE
Nos DAILY
ORAL
Breast Tenderness
Claritin C
Hypertension Nos Nasal Spray C
Multiple Vitamin C
Zinc C
Vitamin E C
Date:
12/17/97 ISR Number: 3049857-X Report Type: Periodic Company Report # 8-97199-029N Age:67 YR Gender: Female I/FU:
F
Outcome PT
Report Source
Product Role Manufacturer Route
Dose Duration
Other Condition Aggravated Consumer Prempro
PS ORAL 1 TABLET ONCE
Sensation Of
Heaviness
DAILY ORAL
Humulin Insulin C
Lescol C
Lotensin C
Paxil C
Synthroid C
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Date:
12/17/97 ISR Number: 3049859-3 Report Type: Periodic Company Report # 8-97213-003R Age: Gender:
Female I/FU: F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Intermenstrual
Bleeding Health Premphase PS ORAL 1 TABLET ONCE
Professional
DAILY ORAL
Date:
12/17/97 ISR Number: 3049864-7 Report Type: Periodic Company Report # 8-97216-026N Age:59 YR
Gender: Female I/FU:
F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Vaginal Discharge Health Prempro PS ORAL 1 TABLET ONCE
Professional DAILY ORAL
Micronase C
Date:
12/17/97 ISR Number: 3049866-0 Report Type: Periodic Company Report # 8-97217-002N Age:51 YR Gender: Female I/FU:
F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Alopecia Health Prempro PS ORAL 1 TABLET ONCE
Intermenstrual
Bleeding Professional DAILY ORAL
Altace C
Hydrochlorothiazide C
Date:
12/17/97 ISR Number: 3049868-4 Report Type: Expedited (15-Day) Company Report # 8-97217-088N Age:55 YR Gender: Female I/FU:
F
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Oedema Lower Limb Health Prempro PS ORAL 1 TABLET ONCE
Pruritus Nos Professional
DAILY ORAL
Vaginal Haemorrhage
Date:
12/17/97 ISR Number: 3051448-1 Report Type: Periodic Company Report # 8-97218-022N Age:56 YR Gender: Female
I/FU: F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Dysgeusia Consumer
Prempro PS ORAL 1 TABLET ONCE
DAILY ON DAYS
1 TO 25 ORAL
Calcium SS UNKNOWN UNKNOWN
Date:
12/17/97 ISR Number: 3051449-3 Report Type: Periodic Company Report # 8-97220-021N Age:50 YR Gender: Female I/FU:
F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Breast Tenderness Health Prempro PS
ORAL 1 TABLET ONCE
Intermenstrual
Bleeding Professional
DAILY ORAL
Night Sweats Claritin D C
Date:
12/17/97 ISR Number: 3051450-X Report Type: Periodic Company Report # 8-97223-030N Age:83 YR Gender: Female I/FU:
F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Intermenstrual
Bleeding Health Prempro PS ORAL 1 TABLET ONCE
Professional
DAILY ORAL
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Date:
12/17/97 ISR Number: 3051451-1 Report Type: Periodic Company Report # 8-97224-014N Age:61 YR Gender: Female I/FU:
F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Dermatitis Nos Health Prempro PS ORAL 1 TABLET ONCE
Drug Eruption Nos Professional
DAILY ORAL
Company
Representative
Date:
12/17/97 ISR Number: 3051452-3 Report Type: Expedited (15-Day) Company Report # 8-97227-005N Age:57 YR Gender: Female I/FU:
F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Alopecia Health Prempro PS ORAL 1 TABLET ONCE
Professional
DAILY ORAL
Nsaid C
Multi-Vitamin, B, C
& Calcium C
Date:
12/17/97 ISR Number: 3051453-5 Report Type: Expedited (15-Day) Company Report # 8-97227-006R Age:52 YR Gender: Female I/FU:
F
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Drug Interaction Nos Health Premphase PS ORAL 1 TABLET ONCE
Haemorrhage Nos Professional DAILY
ORAL
Hot Flushes Nos
Rheumatrex SS ORAL ^15 MG^
WEEKLY
ORAL
Baclofen C
Avonex C
Midrin C
Accupril C
Date:
12/17/97 ISR Number: 3051454-7 Report Type: Expedited (15-Day) Company Report # 8-97227-007R Age:45 YR Gender: Female I/FU:
F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Intermenstrual
Bleeding Consumer Prempro PS ORAL 1 TABLET ONCE
DAILY
ORAL
Date:
12/17/97 ISR Number: 3051455-9 Report Type: Expedited (15-Day) Company Report # 8-97231-016R Age:52 YR Gender: Female I/FU:
F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Intermenstrual Bleeding Consumer Prempro
PS ORAL 1 TABLET ONCE
Pruritus Nos
DAILY ORAL
Prinvil C
Fiorinal C
Date:
12/17/97 ISR Number: 3051456-0 Report Type: Expedited (15-Day) Company Report # 8-97043-018R Age:57 YR Gender: Female I/FU:
F
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other No Adverse Drug Effect Health Prempro PS ORAL 1 TABLET ONCE
Professional DAILY
ORAL
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Date:
12/17/97 ISR Number: 3051457-2 Report Type: Periodic Company Report #
8-97108-008R Age:63 YR Gender:
Female I/FU: F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Alopecia Health Prempro PS ORAL 1 TABLET ONCE
Professional DAILY
ORAL
Date:
12/17/97 ISR Number: 3051458-4 Report Type: Expedited (15-Day) Company Report # 8-97115-013R Age: Gender:
Female I/FU: F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other No Adverse Drug Effect Health Prempro PS ORAL 1 TABLET ONCE
Professional
DAILY ORAL
Company
Representative
Date:
12/19/97 ISR Number: 3009035-7 Report Type: Expedited (15-Day) Company Report # 10196/20246 Age:23 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Abdominal Pain Nos Consumer Depo-Provera
PS INTRAMUSCULAR 150MG 1 DOSE;
Initial or
Prolonged Convulsions Nos Company
IM
Diarrhoea Nos Representative
Fatigue
Haemorrhage Nos
Headache Nos
Intermenstrual
Bleeding
Muscle Cramps
Nervousness
Panic Attack
Syncope
Visual Field Defect
Nos
Weight Decreased
Date:
12/29/97 ISR Number: 3012831-3 Report Type: Expedited (15-Day) Company Report # 10180/20246 Age:
Gender: Unknown I/FU:
F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Congenital
Anomaly Complications Of
Maternal Consumer Depo-Provera PS INTRAMUSCULAR IM
Exposure To
Therapeutic Company
Drugs Representative
Congenital Clubfoot
Congenital
Hydrocephalus
Meningocele
Spina Bifida
Date:
12/31/97 ISR Number: 3013438-4 Report Type: Expedited (15-Day) Company Report # 8-97318-009R Age:74 YR Gender: Female I/FU:
F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Endometrial Cancer Nos Health Prempro PS ORAL 1 TABLET ONCE
Menorrhagia Professional
DAILY ORAL
Ovarian Cyst
Hyzaar C
21-Dec-2001 11:15 AM
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Date: 01/02/98 ISR Number: 3014134-X Report Type: Expedited (15-Day) Company Report # 8562/20246 Age: Gender:
I/FU: F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Life-Threatening Complications Of Maternal Consumer Depo-Provera
PS
INTRAMUSCULAR 150 MG
Congenital
Anomaly Exposure To Therapeutic Company
-1Q3MO;IM
Drugs Representative Intron A Injections C
Foetal Disorder Nos
Intra-Uterine Death
Date:
01/02/98 ISR Number: 3037177-9 Report Type: Periodic Company Report # 8373/20246 Age:24 YR Gender: Female I/FU:
I
Outcome PT Report Source
Product Role Manufacturer Route
Dose Duration
Hospitalization
- Anaphylactic Reaction Health Depo-Provera PS INTRAMUSCULAR 150
Initial or
Prolonged Arthralgia Professional
MG-1Q3MO;IM
Other Chest Pain Company Advil C
Chest Tightness Representative
Face Oedema
Immunocomplex Mediated
Hypersensitivity
Nausea
Urticaria Nos
Date:
01/02/98 ISR Number: 3037180-9 Report Type: Periodic Company Report # 8405/20246 Age:30 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Disability Intermenstrual Bleeding Consumer Depo-Provera
PS 1 DOSE
Menstruation
Irregular Company
Representative
Date:
01/02/98 ISR Number: 3037182-2 Report Type: Periodic Company Report # 8416/20246 Age:43 YR Gender: Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Disability Depression Nos Health Depo-Provera PS INTRAMUSCULAR 150 MG- 1
Other
Professional
DOSE ;IM
Company
Representative
Date:
01/02/98 ISR Number: 3037184-6 Report Type: Periodic Company Report # 8515/20246 Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Depression Nos Consumer Depo-Provera PS INTRAMUSCULAR 150
Initial or
Prolonged Menorrhagia Company
MG-1Q13WK;IM;
Premenstrual
Syndrome Representative
INJ
Date:
01/02/98 ISR Number: 3037185-8 Report Type: Periodic Company Report # 8586/20246 Age:31 YR Gender: Female I/FU:
I
Outcome
Life-Threatening
Hospitalization
-
Initial or
Prolonged
Other
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Required
Intervention
to
Prevent
Permanent PT Report Source Product Role
Manufacturer Route Dose Duration
Impairment/Damage Anaphylactic Reaction Health Depo-Provera PS INTRAMUSCULAR 150 MG - 1
Dizziness (Excl
Vertigo) Professional
DOSE;IM
Dyspnoea Nos Company
Flushing Representative
Hypotension Nos Other
Injection Site Pain
Muscle Spasms
Nausea
Pruritus Nos
Vomiting Nos
Weakness
Date:
01/02/98 ISR Number: 3037188-3 Report Type: Periodic Company Report # 8830/20246 Age:40 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Cerebrovascular Accident Health Depo-Provera PS INTRAMUSCULAR 150 MG -
Initial or
Prolonged Nos Professional
1Q3MO;IM
Other
Date:
01/02/98 ISR Number: 3037190-1 Report Type: Periodic Company Report # 8923/20246 Age:18 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route
Dose Duration
Life-Threatening Anaphylactic Shock Consumer Depo-Provera
PS
INTRAMUSCULAR 150 MG-1
Hospitalization
- Brain Damage (Excl Company DOSE;IM
Initial or
Prolonged Perinatal) Representative
Other Cardio-Respiratory Arrest
Required Cerebral Oedema
Intervention
to Coma
Prevent
Permanent Dizziness (Excl Vertigo)
Impairment/Damage Epistaxis
Eye Haemorrhage Nos
Fluid Retention
Haemorrhage Nos
Mouth Haemorrhage
Rash Erythematous
Swelling Nos
Date:
01/02/98 ISR Number: 3037192-5 Report Type: Periodic Company Report # 8925/20246 Age:31 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Disability Arthralgia Health Depo-Provera PS
INTRAMUSCULAR 150 MG- 1
Professional
DOSE;IM
Company
Representative
Date:
01/02/98 ISR Number: 3037194-9 Report Type: Periodic Company Report # 9025/20246 Age:21 YR Gender: Female I/FU:
I
Outcome PT
Hospitalization
- Blindness Transient
Initial or
Prolonged Cerebral Venous
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Thrombosis
Headache Nos
Intracranial Pressure
Increased Nos Report Source Product Role
Manufacturer Route Dose Duration
Nausea Health Depo-Provera PS INTRAMUSCULAR 150
Professional MG-1Q13WK;IM
Company
Representative
Date:
01/02/98 ISR Number: 3037197-4 Report Type: Periodic Company Report # 9274/20246 Age:22 YR
Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Abdominal Pain Nos Health Depo-Provera PS INTRAMUSCULAR 150 MG - 1
Initial or
Prolonged Drug Ineffective Professional DOSE; IM
Other Streptococcal Infection
Nos
Uterine Haemorrhage
Date:
01/02/98 ISR Number: 3037199-8 Report Type: Periodic Company Report # 9330/20246 Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Gastrointestinal Disorder Consumer Depo-Provera
PS 04 DO
Initial or
Prolonged Nos
Menorrhagia
Weight Decreased
Date:
01/02/98 ISR Number: 3037203-7
Report Type: Periodic
Company Report # 9478/20246
Age:20 YR Gender: Female
I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Dermatitis Nos Health Depo-Provera PS INTRAMUSCULAR 150 MG-
Initial or
Prolonged
Professional
1Q3MO;IM
Company
Representative
Date:
01/02/98 ISR Number: 3037205-0 Report Type: Periodic Company Report #
10007/20246 Age:34 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route
Dose Duration
Life-Threatening Cerebral Artery Health Depo-Provera PS INTRAMUSCULAR 150 MG-1Q3MO
Hospitalization
- Thrombosis Professional
(A);IM
Initial or
Prolonged Cerebrovascular
Accident Company
Disability Nos Representative
Other Coma
Required Difficulty In Walking
Intervention
to Hemiparesis
Prevent
Permanent Hemiplegia
Impairment/Damage Speech Disorder
Date:
01/02/98 ISR Number: 3037209-8 Report Type: Periodic Company Report #
10008/20246 Age:17 YR Gender:
Female I/FU: I
Outcome PT
Hospitalization
- Cerebrovascular Accident
Initial or
Prolonged Nos
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Chest Pain
Headache Nos
Hypoaesthesia Report Source Product Role
Manufacturer Route Dose Duration
Lower Respiratory
Tract Health Depo-Provera PS INTRAMUSCULAR 150 MG -1
Infection Nos Professional DOSE;IM
Paraesthesia Company
Representative
Date:
01/02/98 ISR Number: 3037214-1 Report Type: Periodic Company Report #
10009/20246 Age:37 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Disability Abdominal Pain Nos Consumer Depo-Provera
PS
INTRAMUSCULAR 1 DOSE;IM
Amenorrhoea Nos Company
Back Pain Representative
Dyspareunia Nos
Endometriosis
Insomnia
Intermenstrual
Bleeding
Muscle Cramps
Pelvic Inflammatory
Disease Nos
Date:
01/02/98 ISR Number: 3037220-7 Report Type: Periodic Company Report # 8346/20246 Age:26 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Ecchymosis Health Depo-Provera PS INTRAMUSCULAR 150
MG-
Skin Lesion Nos Professional
1Q3MO;IM
Company
Representative
Date:
01/02/98 ISR Number: 3037225-6 Report Type: Periodic Company Report # 8364/20246 Age: Gender:
Female I/FU: I
Outcome PT
Other Alopecia
Amenorrhoea Nos
Breast Enlargement
Dermatitis Nos
Dizziness (Excl
Vertigo)
Dyspnoea Nos
Gingivitis
Headache Nos
Hot Flushes Nos
Hypersensitivity Nos
Hypoaesthesia
Insomnia
Muscle Cramps
Oedema Lower Limb
Ovarian Pain
Pain Nos
Photosensitivity
Reaction
Nos
Pruritus Nos
Vision Abnormal Nos
Vomiting Nos
Weakness
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Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Weight Increased
Report Source Product Role
Manufacturer Route Dose Duration
Consumer
Depo-Provera PS
Company
Representative
Date:
01/02/98 ISR Number: 3037229-3 Report Type: Periodic Company Report # 8377/20246 Age:42 YR Gender: Female
I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Emotional Disturbance
Nos Health Depo-Provera PS INTRAMUSCULAR 150 MG - 1
Intermenstrual
Bleeding Professional
DOSE; IM
Premenstrual Syndrome Synthroid C
Date:
01/02/98 ISR Number: 3037232-3 Report Type: Periodic Company Report # 8392/20246 Age:18 YR Gender: Female I/FU:
F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Dyspnoea Nos Health Depo-Provera PS
INTRAMUSCULAR 150 MG
Feeling Abnormal Professional
-1Q3MO;IM
Hypersensitivity Nos Company
Nausea Representative
Swelling Nos
Vomiting Nos
Date:
01/02/98 ISR Number: 3037234-7 Report Type: Periodic Company Report # 8400/20246 Age:25 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Culture Throat Positive
Health
Depo-Provera PS INTRAMUSCULAR 150
Erythema Nodosum Professional MG-1Q3MO;IM
Streptococcal
Infection Company
Nos Representative
Date:
01/02/98 ISR Number: 3037236-0 Report Type: Periodic Company Report # 8415/20246 Age:22 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Injection Site
Erythema Health Depo-Provera PS 150 MG-
Professional
1Q1WK;IM
Date:
01/02/98 ISR Number: 3037239-6 Report Type: Periodic Company Report # 8424/20246 Age:23 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Pruritus Nos Health Depo-Provera PS INTRAMUSCULAR 150 MG - 1
Urticaria Nos Professional
DOSE; IM
Company
Representative
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Date:
01/02/98 ISR Number: 3037249-9 Report Type: Periodic Company Report # 8452/20246 Age:
Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Burning Sensation Nos Consumer Depo-Provera
PS
INTRAMUSCULAR 150 MG-1
Pain In Limb
DOSE; IM
Date:
01/02/98 ISR Number: 3037259-1 Report Type: Periodic Company Report # 8461/20246 Age:19 YR Gender: Female I/FU:
I
Outcome PT Report Source Product Role Manufacturer
Route Dose Duration
Other Dizziness (Excl
Vertigo) Health Depo-Provera PS INTRAMUSCULAR 150MG - 1
Dyspnoea Nos Professional
DOSE; IM
Intermenstrual
Bleeding Company
Migraine Nos Representative
Nausea
Photophobia
Rash Pruritic
Urticaria Nos
Date:
01/02/98 ISR Number: 3037260-8 Report Type: Periodic Company Report # 8463/20246 Age:21 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Abdominal Pain Nos Health Depo-Provera PS IM
Arthralgia Professional
Breast Pain Company
Dyspareunia Nos
Representative
Groin Pain
Injection Site Pain
Pain In Limb
Date:
01/02/98 ISR Number: 3037267-0 Report Type: Periodic Company Report # 8479/20246 Age:25 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Anxiety Nec Health Depo-Provera PS INTRAMUSCULAR 150 MG-1
Insomnia Professional DOSE;IM
Suicidal Ideation Company
Representative
Date:
01/02/98 ISR Number: 3037279-7 Report Type: Periodic Company Report # 8519/20246 Age:23 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Abortion Spontaneous Nos
Consumer
Depo-Provera PS INTRAMUSCULAR 150 MG -
Haemorrhage Nos Company 1Q12WK;IM
Pregnancy Nos Representative Pain Killers - - Not
Specified SS
Alcohol Abuse SS
Date:
01/02/98 ISR Number: 3037287-6 Report Type: Periodic Company Report # 8548/20246 Age:24 YR Gender: Female I/FU:
I
Outcome PT
Other Arthralgia
Injection Site Pain
21-Dec-2001 11:15 AM
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Freedom Of Information (FOI) Report
Nausea
Vomiting Nos
Report Source
Product Role Manufacturer Route
Dose Duration
Health Depo-Provera PS INTRAMUSCULAR 150 MG -
Professional
1Q12WK;IM
Midrin C
Date:
01/02/98 ISR Number: 3037302-X Report Type: Periodic Company Report # 8566/20246 Age:22 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Dermatitis Nos Health Depo-Provera PS INTRAMUSCULAR 150 MG -
Food Allergy Professional
1Q12WK;IM
Company
Representative
Date:
01/02/98 ISR Number: 3037308-0 Report Type: Periodic Company Report # 8571/20246 Age: Gender:
Female I/FU: I
Outcome PT
Report Source
Product Role Manufacturer Route
Dose Duration
Other Mood Swings Health Depo-Provera PS
Professional
Company
Representative
Date:
01/02/98 ISR Number: 3037314-6 Report Type: Periodic Company Report # 8580/20246 Age:1 DY Gender: Male I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Abdominal Pain Nos Health Depo-Provera PS INTRAMUSCULAR 150 MG-
Complications Of
Maternal Professional 1Q13WK;IM
Exposure To
Therapeutic Company
Drugs Representative
Drug Ineffective
Foetal Growth
Retardation
Pre-Eclampsia
Date:
01/02/98 ISR Number: 3037321-3 Report Type: Periodic Company Report # 8593/20246 Age:19 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Anxiety Nec Consumer Depo-Provera PS INTRAMUSCULAR IM
Cerebrovascular
Accident Company
Nos Representative
Coordination Abnormal
Nos
Disorientation
Dysarthria
Fall
Fatigue
Headache Nos
Hypoaesthesia
Muscle Cramps
Weakness
21-Dec-2001 11:15 AM
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57
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Freedom
Of Information (FOI) Report
Date:
01/02/98 ISR Number: 3037334-1 Report Type: Periodic Company Report # 8613/20246 Age:39 YR Gender: Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Condition Aggravated Health Depo-Provera PS INTRAMUSCULAR 150 MG-1
Crying Professional
DOSE; IM
Hostility Company
Mood Swings Representative
Date:
01/02/98 ISR Number: 3037338-9 Report Type: Periodic Company Report # 8623/20246 Age:29 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Aggression Health Depo-Provera PS 1 DOSE
Anger Professional Tegretol C
Depression Nos Company Claritin D C
Fatigue Representative
Nervousness
Suicidal Ideation
Date:
01/02/98 ISR Number: 3037343-2 Report Type: Periodic Company Report # 8635/20246 Age:37 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Urticaria Nos Health Depo-Provera PS INTRAMUSCULAR 150 MG- 1
Professional
DOSE;IM
Company
Norplant C
Representative
Date:
01/02/98 ISR Number: 3037352-3 Report Type: Periodic Company Report # 8692/20246 Age:35 YR
Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Injection Site Abscess Health Depo-Provera PS INTRAMUSCULAR 150 MG-
Injection Site
Infection Professional 1Q3MO;IM
Pseudomonas
Aeruginosa Company
Infection Nos Representative
Pyrexia
Rash Erythematous
Date:
01/02/98 ISR Number: 3037353-5 Report Type: Periodic Company Report # 8693/20246 Age:26 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Injection Site Abscess Health Depo-Provera PS INTRAMUSCULAR 150 MG -
Injection Site
Erythema Professional
1Q3MO;IM
Injection Site
Infection
Injection Site Pain
Date:
01/02/98 ISR Number: 3037355-9 Report Type: Periodic Company Report # 8694/20246 Age: Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Injection Site
Infection Health Depo-Provera PS INTRAMUSCULAR 150
Professional MG-1Q3MO;IM
Company
Representative
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Freedom Of
Information (FOI) Report
Date:
01/02/98 ISR Number: 3037356-0 Report Type: Periodic Company Report # 8695/20246 Age:23 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Injection Site
Infection Health Depo-Provera
Professional Contraceptive
Company Injection
(150
Representative Mg/Ml) PS INTRAMUSCULAR 150 MG -
1Q3MO; IM
Date:
01/02/98 ISR Number: 3037363-8 Report Type: Periodic Company Report # 8705/20246 Age:38 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Haemorrhage Nos Health Depo-Provera PS INTRAMUSCULAR 150MG
Hypoaesthesia Professional 1Q12WK;IM
Paralysis Nos Company
Representative
Date:
01/02/98 ISR Number: 3038393-2 Report Type: Periodic Company Report # 8787/20246 Age:22 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Pyrexia Health Depo-Provera PS INTRAMUSCULAR 150 MG 1Q 3
Visual Disturbance
Nos Professional MO ; IM
Date:
01/02/98 ISR Number: 3038397-X Report Type: Periodic Company Report # 8811/20246 Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Hypersensitivity Nos Health Depo-Provera PS
INTRAMUSCULAR 150 MG 1Q 3MO
Sneezing Professional
; IM
Urticaria Nos Company
Vomiting Nos Representative
Other
Date:
01/02/98 ISR Number: 3038429-9 Report Type: Periodic Company Report # 8892/20246 Age:21 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Grunting Health Depo-Provera
PS
INTRAMUSCULAR 150MG 1Q 3MO
Hypersensitivity
Nos Professional
; IM
Paraesthesia Company
Urticaria Nos Representative
Date:
01/02/98 ISR Number: 3038432-9 Report Type: Periodic Company Report # 8894/20246 Age:33 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Injection Site Health Depo-Provera
PS
INTRAMUSCULAR IM
Inflammation Professional
Injection Site
Oedema Company
Neck Stiffness Representative
Paraesthesia
21-Dec-2001 11:15 AM
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Freedom Of Information (FOI) Report
Date:
01/02/98 ISR Number: 3038446-9 Report Type: Periodic Company Report # 8931/20246 Age:21 YR
Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Hypersensitivity Nos Health Depo-Provera PS INTRAMUSCULAR 150 MG-1Q 3MO
Hypoaesthesia Professional ; IM
Injection Site
Irritation Company
Paraesthesia Representative
Swelling Nos
Urticaria Nos
Date:
01/02/98 ISR Number: 3038447-0 Report Type: Periodic Company Report # 8932/20246 Age:41 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer
Route Dose Duration
Other Arthralgia Health Depo-Provera PS
Muscle
Contractions Professional Ppa W/Guaifenesin La C
Involuntary Company Maxide C
Myalgia Representative
Pain In Limb
Sleep Disorder Nos
Weakness
Date:
01/02/98 ISR Number: 3038449-4 Report Type: Periodic Company Report # 8945/20246 Age:27 YR Gender: Female I/FU:
I
Outcome PT Report Source
Product Role Manufacturer Route
Dose Duration
Other Chest Tightness Health Depo-Provera PS INTRAMUSCULAR 150MG 1Q 3 MO
Cough Professional
; IM
Injection Site
Reaction Company Synthroid C
Nos Representative
Oral Pain
Sneezing
Urticaria Nos
Date:
01/02/98 ISR Number: 3038450-0 Report Type: Periodic Company Report # 8952/20246 Age:29 YR
Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Drug Interaction Nos Consumer Depo-Provera
PS
INTRAMUSCULAR 150MG- 1Q 13
Intermenstrual
Bleeding Company WK ; IM
Representative Redux SS ORAL ORAL
Another Unspeified
Weight Loss Med SS
Date:
01/02/98 ISR Number: 3038452-4 Report Type: Periodic Company Report # 8959/20246 Age:15 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Pain Nos Health
Depo-Provera PS INTRAMUSCULAR 150 MG-1
Weakness Professional
DOSE; IM
Company
Representative
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Date:
01/02/98 ISR Number: 3038474-3 Report Type: Periodic Company Report # 8978/20246 Age:19 YR Gender: Female I/FU:
I
Outcome PT Report Source Product Role
Manufacturer Route Dose Duration
Other Uterine Disorder Nos Health Depo-Provera PS INTRAMUSCULAR 150 MG 1 DOSE
Professional
IM
Company
Asthma-Cort C
Representative Ventolin C
Date:
01/02/98 ISR Number: 3038477-9 Report Type: Periodic Company Report # 8985/20246 Age:19 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Unintended Pregnancy Health Depo-Provera PS
INTRAMUSCULAR 150 MG 1
Professional
DOSE ; IM
Company
Representative
Date:
01/02/98 ISR Number: 3038509-8 Report Type: Periodic Company Report # 9054/20246 Age:32 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Diarrhoea Nos Health Depo-Provera PS INTRAMUSCULAR 150 MG
1Q 3
Hypertension Nos Professional
MO ; IM
Weight Increased Company
Representative
Date:
01/02/98 ISR Number: 3038522-0 Report Type: Periodic Company Report # 9133/20246 Age:20 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Abdominal Distension Consumer Depo-Provera
PS INTRAMUSCULAR 150 MG 1Q 3
Alopecia
MO ; IM
Depression Nos
Menorrhagia
Weight Increased
Date:
01/02/98 ISR Number: 3038530-X Report Type: Periodic Company Report # 9173/20246 Age:25 YR Gender: Female I/FU:
I
Outcome PT Report Source
Product Role Manufacturer Route
Dose Duration
Other Medication Error Health Depo-Provera PS INTRAMUSCULAR 150 MG 1 DOSE
Mood Swings Professional
; IM
Company Prenatal
Vitamins C
Representative
Date:
01/02/98 ISR Number: 3038531-1 Report Type: Periodic Company Report # 9176/20246 Age:26 YR Gender: Female I/FU:
I
Outcome PT
Other Amenorrhoea Nos
Required Dizziness (Excl Vertigo)
Intervention
to Headache Nos
Prevent
Permanent Hot Flushes Nos
Impairment/Damage Intermenstrual Bleeding
Menstruation Irregular
Palpitations
21-Dec-2001 11:15 AM
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Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Pruritus Nos
Vision Blurred
Weakness Report Source Product
Role Manufacturer Route Dose
Duration
Consumer
Depo-Provera PS
Company
Representative
Date:
01/02/98 ISR Number: 3038532-3 Report Type: Periodic Company Report # 9184/20246 Age:26 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Pruritus Nos Health
Depo-Provera PS INTRAMUSCULAR 150 MG-1
Professional
DOSE; IM
Other
Date:
01/02/98 ISR Number: 3039315-0 Report Type: Periodic Company Report # 9204/20246 Age:33 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Arthralgia Health Depo-Provera PS INTRAMUSCULAR 150MG
1Q 3 MO
Myalgia Professional
; IM
Company
Representative
Date:
01/02/98 ISR Number: 3039318-6 Report Type: Periodic Company Report # 9205/20246 Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Dermatitis Nos Health Depo-Provera PS INTRAMUSCULAR IM
Urticaria Nos Professional
Company
Representative
Date:
01/02/98 ISR Number: 3039325-3 Report Type: Periodic Company Report # 9218/20246 Age:16 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Drug Hypersensitivity Health Depo-Provera PS INTRAMUSCULAR 150 MG 1Q 3MO
Oedema Upper Limb Professional
; IM
Company
Methylphenidate C
Representative
Date:
01/02/98 ISR Number: 3039342-3 Report Type: Periodic Company Report # 9221/20246 Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer
Route Dose Duration
Other Pruritus Nos Health Depo-Provera PS
Professional
Company
Representative
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Date: 01/02/98 ISR Number: 3039345-9 Report Type: Periodic Company Report # 9222/20246 Age:16 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Erythema Nodosum Health Depo-Provera PS INTRAMUSCULAR 150 MG -
Professional
1Q3MO;IM
Company
Augmentin SS
Representative
Date:
01/02/98 ISR Number: 3039352-6 Report Type: Periodic Company Report # 9250/20246 Age:18 YR Gender: Female I/FU:
I
Outcome PT Report Source Product Role Manufacturer
Route Dose Duration
Other Abdominal Distension Health Depo-Provera PS INTRAMUSCULAR 150 MG- 1
Arthralgia Professional
DOSE; IM
Chest Pain Company
Pain In Limb Representative
Paraesthesia
Date:
01/02/98 ISR Number: 3039369-1 Report Type: Periodic Company Report # 9273/20246 Age:29 YR Gender: Female I/FU:
I
Outcome PT Report Source
Product Role Manufacturer Route
Dose Duration
Other Hypertension Nos Health Depo-Provera PS INTRAMUSCULAR 150 MG -
Migraine
Aggravated Professional
1Q3MO ; IM
Weight Increased Company
Representative
Date:
01/02/98 ISR Number: 3039378-2 Report Type: Periodic Company Report # 9282/20246 Age:19 YR Gender: Female I/FU:
I
Outcome PT Report Source
Product Role Manufacturer Route
Dose Duration
Other Dizziness (Excl
Vertigo) Health Depo-Provera PS INTRAMUSCULAR 150 MG - 1
Oedema Lower Limb Professional
DOSE ; IM
Pruritus Nos
Rash Papular
Urticaria Nos
Date:
01/02/98 ISR Number: 3039386-1 Report Type: Periodic Company Report # 9291/20246 Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Appetite Decreased Nos Health Depo-Provera PS 1 DOSE
Chest Pain Professional
Chest Tightness Company
Dizziness (Excl
Vertigo) Representative
Eye Pain
Flatulence
Neck Stiffness
Palpitations
Photosensitivity
Reaction
Nos
Pyrexia
Sweating Increased
Syncope
Tremor
Weakness
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Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:
01/02/98 ISR Number: 3039410-6 Report Type: Expedited (15-Day) Company Report # 9324/20246 Age:25 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Depression Nos Health Depo-Provera
Irritability Professional Contraceptive
Mood Swings Company Injection
PS
INTRAMUSCULAR 150 MG - 1
Representative
DOSE ; IM
Date: 01/02/98 ISR Number: 3039413-1 Report Type: Periodic Company Report # 9329/20246 Age:28 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Urticaria Nos Health Depo-Provera PS INTRAMUSCULAR 150
Professional
MG/ML/DAY;IM
Company
Representative
Date:
01/02/98 ISR Number: 3039423-4 Report Type: Periodic Company Report # 9362/20246 Age:30 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Drug Hypersensitivity Health Depo-Provera PS INTRAMUSCULAR IM
Injection Site
Reaction Professional
Nos
Paraesthesia
Rash Erythematous
Date:
01/02/98 ISR Number: 3039426-X Report Type: Periodic Company Report # 9371/20246 Age:19 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Anaphylactic Reaction Health Depo-Provera
PS
INTRAMUSCULAR 150 MG -
Blood Pressure
Decreased Professional
1Q12WK ; IM
Chest Pain Company Zoloft C
Feeling Hot Representative Ritalin C
Mottled Skin
Oedema Upper Limb
Pain In Limb
Pyrexia
Rash Erythematous
Throat Tightness
Urticaria Nos
Date:
01/02/98 ISR Number: 3039438-6 Report Type: Periodic Company Report # 9413/20246 Age:40 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Burning Sensation Nos Health Depo-Provera PS INTRAMUSCULAR 150 MG -
Drug
Hypersensitivity
Professional
1Q3M0 ; IM
Throat Irritation Company
Urticaria Nos Representative
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Date:
01/02/98 ISR Number: 3039440-4 Report Type: Periodic Company Report # 9417/20246 Age:19 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Headache Nos Health Depo-Provera PS INTRAMUSCULAR
150 MG -
Injection Site
Oedema Professional
1Q3MO ; IM
Injection Site
Pain Company
Rash Erythematous Representative
Rash Pruritic
Date:
01/02/98 ISR Number: 3039449-0 Report Type: Periodic Company Report # 9457/20246 Age:44 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Depression Nos Health Depo-Provera PS INTRAMUSCULAR 1 DOSE ; IM
Hypoaesthesia Professional Testoterone SS
Menorrhagia Company Zantac C
Representative
Date:
01/02/98 ISR Number: 3039452-0 Report Type: Periodic Company Report # 9477/20246 Age:24 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Urticaria Nos Health Depo-Provera PS
INTRAMUSCULAR 150 MG - 1
Professional
DOSE ; IM
Company
Representative
Date:
01/02/98 ISR Number: 3039455-6 Report Type: Periodic Company Report # 9488/20246 Age:22 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Injection Site
Irritation Health Depo-Provera PS
INTRAMUSCULAR 150 MG -
Muscle Cramps Professional
1Q3MO ; IM
Date:
01/02/98 ISR Number: 3039457-X Report Type: Periodic Company Report # 9493/20246 Age:22 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Required Bradycardia Foetal Health Depo-Provera PS INTRAMUSCULAR IM
Intervention
to Drug Ineffective Professional
Prevent
Permanent Polyhydramnios Company
Impairment/Damage Premature Labour Representative
Date:
01/02/98 ISR Number: 3039465-9 Report Type: Periodic Company Report # 9504/20246 Age:28 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Face Oedema Health Depo-Provera
PS
INTRAMUSCULAR 150 MG -
Urticaria Nos Professional
1Q13WK ; IM
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Date:
01/02/98 ISR Number: 3039478-7 Report Type: Periodic Company Report # 9525/20246 Age:26 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Dizziness (Excl
Vertigo) Health Depo-Provera
PS
INTRAMUSCULAR 150 MG - 1
Galactorrhoea Professional
DOSE ; IM
Hot Flushes Nos
Intermenstrual
Bleeding
Menorrhagia
Menstruation Irregular
Nausea
Night Sweats
Pain Nos
Date:
01/02/98 ISR Number: 3039482-9 Report Type: Periodic Company Report # 9531/20246 Age:34 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Hypotension Nos Health Depo-Provera PS INTRAMUSCULAR IM
Nausea Professional
Insulin C
Sweating
Increased Company Serzone C
Vomiting Nos Representative Cimetidine C
Reglan C
Lisinopril C
Date:
01/02/98 ISR Number: 3039490-8 Report Type: Periodic Company Report # 9551/20246 Age:28 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Chest Pain Health Depo-Provera PS INTRAMUSCULAR 150 MG -
Drug
Hypersensitivity
Professional
1Q13WK; IM
Haematoma Nos Company
Headache Nos Representative
Hypoaesthesia
Injection Site Erythema
Injection Site Pain
Injection Site
Pruritus
Injection Site
Reaction
Nos
Lymphadenopathy
Rash Erythematous
Scar
Urticaria Nos
Date:
01/02/98 ISR Number: 3039497-0 Report Type: Periodic Company Report # 9554/20246 Age:20 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Drug Hypersensitivity Health Depo-Provera
PS INTRAMUSCULAR 150 MG - 1
Urticaria Nos Professional
DOSE; IM
Date:
01/02/98 ISR Number: 3039506-9 Report Type: Periodic
Company Report # 9564/20246
Age:19 YR Gender: Female
I/FU: I
Outcome PT
Other Amenorrhoea Nos
Breast Enlargement
Galactorrhoea
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Ovarian Enlargement
Report Source Product Role
Manufacturer Route Dose Duration
Health
Depo-Provera PS INTRAMUSCULAR 150 MG -
Professional
1Q12WK; IM
Date:
01/02/98 ISR Number: 3039525-2 Report Type: Periodic Company Report # 9602/20246 Age: Gender: Female
I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Haemoglobin Decreased Health Depo-Provera PS
Haemorrhage Nos Professional
Company
Representative
Date:
01/02/98 ISR Number: 3039534-3 Report Type: Periodic Company Report # 9652/20246 Age:29 YR Gender: Female I/FU:
I
Outcome PT Report Source Product Role
Manufacturer Route Dose Duration
Other Feeling Cold Health Depo-Provera PS INTRAMUSCULAR 150 MG -
Hypoaesthesia Professional
1Q13WK ; IM
Company
Representative
Date:
01/02/98 ISR Number: 3039539-2 Report Type: Periodic Company Report # 9665/20246 Age:32 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer
Route Dose Duration
Other Back Pain Consumer Depo-Provera PS INTRAMUSCULAR 150 MG - 1
Lactose Intolerance Company
DOSE; IM
Nausea Representative Prenatal Vitamin C
Date:
01/02/98 ISR Number: 3039548-3 Report Type: Periodic Company Report # 9686/20246 Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Accidental Exposure Health Depo-Provera PS 150 MG - 1
Device Failure,
Defect Professional DOSE
;
Eye Irritation Company
TOPICAL
Madarosis Representative
Date:
01/02/98 ISR Number: 3039550-1 Report Type: Periodic Company Report # 9688/20246 Age:21 YR Gender: Female I/FU:
I
Outcome PT Report Source
Product Role Manufacturer Route
Dose Duration
Other Drug Hypersensitivity Health Depo-Provera PS INTRAMUSCULAR 150 MG
Hypoaesthesia Professional
-1Q12WK; IM
Injection Site Oedema
Injection Site Pain
Injection Site
Pruritus
Injection Site
Reaction
Nos
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Date:
01/02/98 ISR Number: 3039553-7 Report Type: Periodic Company Report # 9715/20246 Age:37 YR Gender: Female I/FU:
I
Outcome PT Report Source Product Role
Manufacturer Route Dose Duration
Other Urticaria Nos Consumer Depo-Provera PS INTRAMUSCULAR IM
Company
Representative
Date:
01/02/98 ISR Number: 3039560-4 Report Type: Periodic Company Report # 9761/20246 Age:16 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Dyspnoea Nos Health Depo-Provera PS
INTRAMUSCULAR 150 MG/ML 1
Palpitations Professional
DOSE; IM
Urticaria Nos Epsom Salt C
Date:
01/02/98 ISR Number: 3039563-X Report Type: Periodic Company Report # 9771/20246 Age:24 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Pregnancy Test False Health Depo-Provera PS INTRAMUSCULAR 150 MG -
Positive Professional
1Q3MO ; IM
Company
Representative
Date:
01/02/98 ISR Number: 3039565-3 Report Type: Periodic Company Report # 9772/20246 Age:37 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Diarrhoea Nos Health Depo-Provera PS INTRAMUSCULAR 150 MG -
Rectal
Haemorrhage Professional
1Q13WK ; IM
Company
Representative
Date:
01/02/98 ISR Number: 3040232-0 Report Type: Periodic Company Report # 9782/20246 Age:21 YR Gender: Female I/FU:
I
Outcome PT Report Source
Product Role Manufacturer Route
Dose Duration
Other Injection Site Oedema Health Depo-Provera PS INTRAMUSCULAR IM
Injection Site
Urticaria Professional
Date:
01/02/98 ISR Number: 3040251-4 Report Type: Periodic Company Report # 9811/20246 Age:37 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Intermenstrual
Bleeding Health Depo-Provera PS
INTRAMUSCULAR 150 MG -
Irritability Professional
1Q12WK ; IM
Company
Representative
Date:
01/02/98 ISR Number: 3040260-5 Report Type: Periodic Company Report # 9826/20246 Age:23 YR Gender: Female I/FU:
I
Outcome PT
Other Injection Site Dermatitis
Injection Site
Pruritus
21-Dec-2001 11:15 AM
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Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Photosensitivity Reaction
Nos
Report Source
Product Role Manufacturer Route
Dose Duration
Health Depo-Provera PS INTRAMUSCULAR 150 MG -
Professional
1Q12WK ; IM
Company
Representative
Date:
01/02/98 ISR Number: 3040263-0 Report Type: Periodic Company Report # 9861/20246 Age:20 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Drug Ineffective Health Depo-Provera PS INTRAMUSCULAR 150
Drug Interaction
Nos Professional
MG-1Q12WK;IM
Medication Error Company Intravenous Fluids SS INTRAVENOUS
Representative DRIP
IV
Date:
01/02/98 ISR Number: 3040264-2 Report Type: Periodic Company Report # 9860/20246 Age:35 YR Gender: Female I/FU:
I
Outcome PT Report Source
Product Role Manufacturer Route
Dose Duration
Other Injection Site
Erythema Health Depo-Provera PS INTRAMUSCULAR 150 MG -
Injection Site
Induration Professional
1Q12WK; IM
Injection Site
Oedema Company
Injection Site
Pruritus Representative
Injection Site
Vesicles
Date:
01/02/98 ISR Number: 3040278-2 Report Type: Periodic Company Report # 9891/20246 Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Injection Site
Erythema Health Depo-Provera PS
ORAL 150 MG -
Injection Site
Necrosis Professional
1Q2MO;ORAL
Injection Site Oedema Company
Injection Site
Pain Representative
Injection Site
Pruritus
Scab
Date:
01/02/98 ISR Number: 3040279-4 Report Type: Periodic Company Report # 9896/20246 Age:27 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Injection Site Oedema
Health
Depo-Provera PS INTRAMUSCULAR 150 MG - 1
Injection Site Professional DOSE; IM
Pigmentation
Changes Company
Injection Site
Vesicles Representative
Date:
01/02/98 ISR Number: 3040280-0 Report Type: Periodic Company Report # 9910/20246 Age:33 YR Gender: Female I/FU:
I
Outcome PT
Other Back Pain
Blood Pressure
Increased
Chest Pain
Dizziness (Excl Vertigo)
Dyspnoea Nos
21-Dec-2001 11:15 AM
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FDA - Adverse Event
Reporting System (AERS)
Freedom Of Information (FOI) Report
Feeling Hot And Cold
Hyperventilation
Muscle Tightness Report Source
Product Role Manufacturer Route
Dose Duration
Nausea Health Depo-Provera PS
INTRAMUSCULAR 150 MG - 1
Pallor Professional
DOSE ; IM
Palpitations
Paraesthesia
Paraesthesia Oral Nos
Sweating Increased
Tremor
Vasovagal Attack
Date:
01/02/98 ISR Number: 3040287-3 Report Type: Periodic Company Report # 9954/20246 Age:24 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Hypoaesthesia Consumer Depo-Provera PS INTRAMUSCULAR 150 MG - 1
Pain Nos DOSE ; IM
Visual Disturbance Nos
Date:
01/02/98 ISR Number: 3040290-3 Report Type: Periodic Company Report # 9961/20246 Age:20 YR Gender: Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Pruritus Nos Health Depo-Provera PS INTRAMUSCULAR 150 MG,
Urticaria Nos Professional
1Q3MO; IM
Company
Representative
Date:
01/02/98 ISR Number: 3040300-3 Report Type: Periodic Company Report # 9979/20246 Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Dry Eye Nos Health Depo-Provera
Professional
Contraceptive PS INTRAMUSCULAR 150MG-1Q12WK
Company
: IM
Representative
Date:
01/02/98 ISR Number: 3040315-5 Report Type: Periodic Company Report # 10014/20246 Age:21 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Injection Site Health Depo-Provera PS INTRAMUSCULAR 150 MG -
Haemorrhage Professional
1Q12WK; IM
Injection Site Company
Inflammation Representative
Injection Site Oedema
Injection Site Pain
Petechiae
Date: 01/02/98 ISR Number: 3040317-9 Report Type: Periodic Company Report #
10018/20246 Age:30 YR Gender:
Female I/FU: I
Outcome PT
Other Chest Tightness
Dyspnoea Nos
21-Dec-2001 11:15 AM
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FDA -
Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Injection Site
Urticaria
Report Source Product Role Manufacturer
Route Dose Duration
Health
Depo-Provera PS INTRAMUSCULAR 150 MG -
Professional
DOSE; IM
Company
Representative
Date:
01/02/98 ISR Number: 3040321-0 Report Type: Periodic Company Report # 10025/20246 Age:17 YR Gender: Female I/FU:
I
Outcome PT Report Source Product Role
Manufacturer Route Dose Duration
Other Injection Site
Dermatitis Health Depo-Provera PS INTRAMUSCULAR 150 MG -
Injection Site Professional
1Q3MO; IM
Hypersensitivity Company
Injection Site
Oedema Representative
Injection Site Pain
Medication Error
Date:
01/02/98 ISR Number: 3040322-2 Report Type: Periodic Company Report # 10028/20246 Age:19 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Akinesia Health Depo-Provera PS
INTRAMUSCULAR 150 MG -
Cellulitis Professional
1A3MO; IM
Injection Site Bruising
Injection Site
Inflammation
Injection Site
Necrosis
Injection Site Oedema
Injection Site Pain
Keloid Scar
Pregnancy Nos
Scar
Date:
01/02/98 ISR Number: 3040323-4 Report Type: Periodic Company Report # 10029/20246 Age:35 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other No Adverse Drug Effect Health Depo-Provera PS
INTRAMUSCULAR 150 MG - 1
Professional
DOSE; IM
Company
Representative
Date:
01/02/98 ISR Number: 3040326-X Report Type: Periodic Company Report # 10041/20246 Age:31 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Rheumatoid Arthritis Consumer Depo-Provera
PS INTRAMUSCULAR 150 MG
Aggravated Company
-1Q12WK; IM
Representative Methotrexate C
Plaquenil C
Tolmentin C
Folic Acid C
21-Dec-2001 11:15 AM
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FDA - Adverse
Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:
01/02/98 ISR Number: 3040328-3 Report Type: Periodic Company Report #
10055/20246 Age: Gender: Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Drug Ineffective Health Depo-Provera PS INTRAMUSCULAR IM
Professional Plasma
Donation
Company (Plasmapheresis) SS 690 - 880 ML
Representative - 2Q1WK
Date:
01/02/98 ISR Number: 3040329-5 Report Type: Periodic Company Report # 5618/20246 Age:22 YR Gender: Female I/FU:
I
Outcome PT Report Source
Product Role Manufacturer Route
Dose Duration
Other Abdominal Pain Nos Health Depo-Provera PS INTRAMUSCULAR 150 MG - 1
Face Oedema Professional
DOSE; IM
Nausea
Pruritus Nos
Urticaria Nos
Vaginal Haemorrhage
Date:
01/02/98 ISR Number: 3040332-5 Report Type: Periodic Company Report # 7177/20246 Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Appetite Decreased Nos Consumer Depo-Provera
PS INTRAMUSCULAR 150 MG-1Q3MO;
Dizziness (Excl
Vertigo) Company
IM
Headache Nos Representative
Loss Of Consciousness
Migraine Nos
Nausea
Visual Acuity Reduced
Date:
01/02/98 ISR Number: 3040341-6 Report Type: Periodic Company Report # 8159/20246 Age:21 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Injection Site
Dermatitis Health Depo-Provera PS INTRAMUSCULAR 150 MG -
Required Injection Site Erythema Professional
1Q3MO; IM
Intervention
to Injection Site Company
Prevent
Permanent Hypersensitivity Representative
Impairment/Damage Injection Site Pain
Injection Site
Reaction
Nos
Purpura Nos
Skin Vasculitis Nos
Date:
01/02/98 ISR Number: 3040346-5 Report Type: Periodic Company Report # 8220/20246 Age:19 YR Gender: Female I/FU:
F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Hepatitis Nos Health Depo-Provera PS
INTRAMUSCULAR 150 MG - 1
Jaundice Nos Professional
DOSE;IM
Liver Function Tests
Nos Company
Abnormal Representative
21-Dec-2001 11:15 AM
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Freedom Of Information (FOI) Report
Date:
01/02/98 ISR Number: 3040347-7 Report Type: Periodic Company Report # 8302/20246 Age:20 YR Gender: Female I/FU:
F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Anaemia Nos Consumer Depo-Provera PS INTRAMUSCULAR 150 MG - 1
Confusion Company DOSE;
IM
Depression Nos Representative
Menorrhagia
Mood Swings
Date:
01/03/98 ISR Number: 3037251-7 Report Type: Periodic Company Report # 8460/20246 Age:23 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Vaginal Haemorrhage Health Depo-Provera PS INTRAMUSCULAR 150 MG -
Professional
1Q13WK;IM
Company Septra
Ds SS ORAL ORAL
Representative
Date:
01/05/98 ISR Number: 3013579-1 Report Type: Expedited (15-Day) Company Report # 4145/11839 Age:49 YR Gender: Female I/FU:
I
Outcome PT Report Source
Product Role Manufacturer Route
Dose Duration
Disability Fibromyalgia Syndrome Health Provera PS ORAL
2.5-10MG-1Q1D
Other Pain Nos Professional
Y;
Required
Company
Estrogen C
Intervention
to
Representative
Prevent
Permanent
Impairment/Damage
Date:
01/05/98 ISR Number: 3014443-4 Report Type: Expedited (15-Day) Company Report # 9967/20246 Age:29 YR Gender: Female I/FU:
F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Death Cardio-Respiratory
Arrest Health Depo-Provera
PS
INTRAMUSCULAR 150
Life-Threatening Coagulation Disorder Nos Professional
MG-1Q3MO;IM
Hospitalization
- Convulsions Nos
Company Advil C
Initial or
Prolonged Electroencephalogram Representative Tylenol C
Required Abnormal
Intervention
to Electrolyte Imbalance
Prevent
Permanent Epistaxis
Impairment/Damage Gallbladder Disorder Nos
Hepatic Disorder Nos
Hepatic Encephalopathy
Hepatic Failure
Hepatitis B
Hypokalaemia
Jaundice Cholestatic
Mental Disorder Nos
Shock
Weakness
Date:
01/07/98 ISR Number: 3076895-3 Report Type: Periodic Company Report #
8-96352-001P Age:58 YR Gender: I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Pruritus Nos Consumer Cycrin PS ORAL 2.5 MG ONCE
DAILY ORAL
21-Dec-2001 11:15 AM
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Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Motrin C
Multiple Vitamin
Injection C
Premarin C
Vitamin E C
Date:
01/07/98 ISR Number: 3076896-5 Report Type: Periodic Company Report #
8-97063-003R Age:46 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Condition Aggravated
Health Cycrin PS ORAL 2.5 MG ONCE
Skin Atrophy Professional
DAILY ORAL
Skin
Hyperpigmentation
Estrace C
Date:
01/07/98 ISR Number: 3076903-X Report Type: Periodic Company Report # 8-97070-001N Age:50 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Vaginal Candidiasis Consumer
Cycrin PS ORAL 2.5 MG ONCE
DAILY ORAL
Premarin C
TAB
Date:
01/07/98 ISR Number: 3076904-1 Report Type: Periodic Company Report # 8-97092-002N Age:53 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Headache Nos Consumer Cycrin PS ORAL 2.5 MG ONCE
Hypoaesthesia
DAILY ORAL
Pain In Limb
Estrace C
Weakness
Weight Increased
Date:
01/07/98 ISR Number: 3076907-7 Report Type: Periodic Company Report #
8-97114-019R Age:53 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Drug Ineffective Consumer Cycrin PS ORAL 2.5 MG ONCE
Heat Rash DAILY ORAL
Localised
Exfoliation
Ortho-Est C
Pityriasis Rosea
Prozac C
Rash Erythematous
Rash Papular
Rash Pruritic
Rash Scaly
Rosacea
Date:
01/07/98 ISR Number: 3076910-7 Report Type: Periodic Company Report #
8-97135-007R Age:60 YR Gender:
Female I/FU: I
Outcome PT
Other Breast Enlargement
Breast Pain
Dermatitis Nos
Influenza
Markedly Reduced
Dietary
Intake
21-Dec-2001 11:15 AM
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Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Nervousness
Report Source
Product Role Manufacturer Route
Dose Duration
Consumer Cycrin PS ORAL 2.5 MG ORAL
Estrace SS 0.5
MG
Prilosec C
Synthroid C
Ambien C
Date:
01/07/98 ISR Number: 3076912-0 Report Type: Periodic Company Report # 8-97160-001R Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Blood Pressure
Increased Consumer Cycrin PS ORAL 2.5 MG ONCE
Genital Pruritus Female
DAILY ORAL
Vaginal Discharge
Estrogen SS
Vulvovaginal Discomfort
Date:
01/07/98 ISR Number: 3076914-4 Report Type: Periodic Company Report # 8-97161-001R Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Intermenstrual
Bleeding Health Cycrin PS ORAL 2.5 MG ORAL
Professional
Date:
01/07/98 ISR Number: 3076916-8 Report Type: Periodic Company Report # 8-97213-020N Age:61 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Migraine Nos Health Cycrin PS ORAL 2.5
MG ORAL
Professional
Premarin C
Date:
01/07/98 ISR Number: 3076917-X Report Type: Periodic Company Report # 8-97307-007R Age:51 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Hypersensitivity Nos Health
Cycrin PS ORAL 2.5 MG ONCE
Rash Erythematous Professional
DAILY ORAL
Rash Pruritic
Estraderm Patch 1
Patch Weekly C
Premarin C
Date:
01/07/98 ISR Number: 3076920-X Report Type: Periodic Company Report # 8-97351-001R Age:49 YR Gender: Female I/FU:
I
Outcome PT Report Source
Product Role Manufacturer Route
Dose Duration
Other Headache Nos Health Cycrin PS ORAL 2.5 MG ONCE
Professional
DAILY ORAL
Premarin SS ORAL 1.25 MG DAILY
ORAL
Redux SS ORAL 30 MG DAILY
ORAL
Accupril C
21-Dec-2001 11:15 AM
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Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:
01/07/98 ISR Number: 3076922-3
Report Type: Periodic
Company Report # 8-96298-006N
Age:66 YR Gender: Female
I/FU: F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Intermenstrual
Bleeding Health Cycrin PS ORAL 2.5 MG ONCE
Professional
DAILY ORAL
Date:
01/07/98 ISR Number: 3076925-9 Report Type: Periodic Company Report # 8-97112-004N Age:60 YR Gender: Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Dysmenorrhoea Health Cycrin PS 5 MG ONCE
Professional
DAILY
Date:
01/07/98 ISR Number: 3076927-2 Report Type: Periodic Company Report #
8-97178-004R Age:62 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Appetite Decreased Nos Consumer Cycrin
PS
ORAL 5.0 MG ONCE
Depression Nos DAILY
ORAL
Eye Pain
Aspirin C
Menorrhagia Melatonin C
Muscle Cramps
Premarin C
Muscle Weakness Nos
Pain Nos
Premenstrual Syndrome
Date:
01/07/98 ISR Number: 3076928-4 Report Type: Periodic Company Report # 8-97182-011R Age:61 YR Gender: Female I/FU:
I
Outcome PT Report Source Product Role
Manufacturer Route Dose Duration
Other Dysmenorrhoea Consumer Cycrin PS ORAL 5 MG ONCE
Intermenstrual
Bleeding
DAILY ORAL
Cardizem C
Date:
01/07/98 ISR Number: 3076931-4 Report Type: Periodic Company Report #
8-97218-027N Age:49 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route
Dose Duration
Other Palpitations Consumer Cycrin PS ORAL 2.5-5.0 MG
Syncope (DAYS
15-25)
ORAL
Estradiol C
Date:
01/07/98 ISR Number: 3088963-0 Report Type: Periodic Company Report # 8-96352-001P Age:58 YR Gender:
I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Pruritus Nos Consumer Cycrin PS ORAL 2.5 MG ONCE
DAILY ORAL
Motrin
Prn C
Multiple Vitamin
Injection C
Premarin C
Vitamin E C
21-Dec-2001 11:15 AM Page:
76
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Information (FOI) Report
Date:
01/07/98 ISR Number: 3088967-8 Report Type: Periodic Company Report # 8-97063-003R Age:46 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Skin Atrophy Health Cycrin PS ORAL 2.5
MG ONCE
Skin
Hyperpigmentation
Professional
DAILY ORAL
Estrace C
Date:
01/07/98 ISR Number: 3088971-X Report Type: Periodic Company Report # 8-97070-001N Age:50 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Vaginal Candidiasis Consumer Cycrin
PS
ORAL 2.5 MG ONCE
DAILY ORAL
Premarin C
Date:
01/07/98 ISR Number: 3088976-9 Report Type: Periodic Company Report # 8-97092-002N Age:53 YR Gender: Female I/FU:
I
Outcome PT Report Source Product Role
Manufacturer Route Dose Duration
Other Headache Nos Consumer Cycrin PS ORAL 2.5 MG ONCE
Hypoaesthesia
DAILY ORAL
Pain In Limb
Estrace C
Weakness
Weight Increased
Date:
01/07/98 ISR Number: 3088978-2 Report Type: Periodic Company Report # 8-97114-019R Age:53 YR Gender: Female I/FU:
I
Outcome PT Report Source
Product Role Manufacturer Route
Dose Duration
Other Drug Ineffective Consumer Cycrin PS ORAL 2.5 MG NCE
Heat Rash
DAILY ORAL
Localised
Exfoliation
Ortho-Est C
Pruritus Nos
Prozac C
Rash Erythematous
Rash Papular
Rash Scaly
Rosacea
Date:
01/07/98 ISR Number: 3088981-2 Report Type: Periodic Company Report # 8-97135-007R Age:60 YR Gender: Female I/FU:
I
Outcome PT Report Source Product Role
Manufacturer Route Dose Duration
Other Appetite Disorder Nos Consumer Cycrin
PS
ORAL 2.5 MG ORAL
Breast
Enlargement
Estrace SS 0.5
MG
Breast Pain
Estrace SS
Dermatitis Nos
Prilosec C
Influenza
Synthroid C
Nervousness
Ambien C
Rash Erythematous
Date:
01/07/98 ISR Number: 3088983-6 Report Type: Periodic Company Report # 8-97160-001R Age: Gender:
Female I/FU: I
Outcome PT
Other Blood Pressure Increased
Pruritus Nos
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FDA - Adverse
Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Vaginal Discharge
Vulvovaginal Discomfort
Report Source
Product Role Manufacturer Route
Dose Duration
Consumer Cycrin PS ORAL 2.5 MG ONCE
DAILY ORAL
Estrogen SS
Date:
01/07/98 ISR Number: 3088987-3 Report Type: Periodic Company Report # 8-97161-001R Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Intermenstrual
Bleeding Health Cycrin PS ORAL 2.5 MG ORAL
Professional
Date:
01/07/98 ISR Number: 3088991-5 Report Type: Periodic Company Report # 8-97213-020N Age:61 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Migraine Nos Health
Cycrin PS ORAL 2.5 MG ORAL
Professional
Premarin C
Date:
01/07/98 ISR Number: 3088996-4 Report Type: Periodic Company Report #
8-97307-007R Age:51 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Hypersensitivity Nos Health Cycrin PS ORAL 2.5 MG ONCE
Pruritus Nos Professional DAILY
ORAL
Rash Erythematous Estraderm
Patch C
Premarin C
Date:
01/07/98 ISR Number: 3088997-6 Report Type: Periodic Company Report # 8-97351-001R Age:49 YR Gender: Female I/FU:
I
Outcome PT Report Source Product Role Manufacturer
Route Dose Duration
Other Headache Nos Health Cycrin PS ORAL 2.5 MG ONCE
Neck Pain Professional
DAILY ORAL
Premarin SS ORAL
1.25 MG DAILY
ORAL
Redux Capsules SS ORAL 30 MG DAILY
ORAL
Accupril C
Date:
01/07/98 ISR Number: 3088998-8 Report Type: Periodic Company Report # 8-96298-006N Age:66 YR Gender: Female I/FU:
F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Intermenstrual
Bleeding Health Cycrin PS ORAL 2.5 MG ONCE
Professional
DAILY ORAL
Date:
01/07/98 ISR Number: 3088999-X Report Type: Periodic Company Report # 8-97112-004N Age:60 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Dysmenorrhoea Health Cycrin PS 5 MG ONCE
Professional DAILY
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Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:
01/07/98 ISR Number: 3089001-6 Report Type: Periodic Company Report #
8-97178-004R Age:62 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Appetite Decreased Nos Consumer Cycrin
PS
ORAL 5.0 MG ONCE
Depression Nos
DAILY ORAL
Eye Pain
Aspirin C
Menorrhagia
Melatonin C
Muscle Cramps
Premarin C
Muscle Weakness Nos
Pain Nos
Premenstrual Syndrome
Date:
01/07/98 ISR Number: 3089003-X Report Type: Periodic Company Report #
8-97182-011R Age:61 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Dysmenorrhoea Consumer Cycrin PS ORAL 5 MG ONCE
Intermenstrual
Bleeding DAILY
ORAL
Cardizem C
Date:
01/07/98 ISR Number: 3089005-3 Report Type: Periodic Company Report #
8-97218-027N Age:49 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Heart Rate Irregular Consumer Cycrin
PS
ORAL 2.5 - 5.0
Syncope (DAY 15-25)
ORAL
Estradiol C
Date:
01/12/98 ISR Number: 3016229-3 Report Type: Expedited (15-Day) Company Report # 8-97363-005R Age:54 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Abdominal Pain Nos Consumer Prempro
PS ORAL 1 TABLET ONCE
Initial or
Prolonged Cholelithiasis
DAILY ORAL
Gastrointestinal
Disorder
Nos
Date:
01/12/98 ISR Number: 3016563-7 Report Type: Expedited (15-Day) Company Report # 10196/20246 Age:23 YR Gender: Female I/FU:
F
Outcome PT Report Source Product Role
Manufacturer Route Dose Duration
Hospitalization
- Abdominal Pain Nos Health Depo-Provera PS INTRAMUSCULAR 150 MG - 1
Initial or
Prolonged Convulsions Nos Professional
DOSE; IM
Diarrhoea Nos Company
Fatigue Representative
Haemorrhage Nos
Headache Nos
Muscle Cramps
Nervousness
Panic Attack
Syncope
Visual Disturbance Nos
Weight Decreased
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Date:
01/13/98 ISR Number: 3015112-7 Report Type: Expedited (15-Day) Company Report # 8-98007-001R Age: Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Myocardial Infarction Consumer Premarin
PS
ORAL ORAL
Initial or
Prolonged
Provera SS ORAL
ORAL
Date:
01/13/98 ISR Number: 3015240-6 Report Type: Expedited (15-Day) Company Report # 606/20246 Age:25 YR Gender: Female I/FU:
F
Outcome PT Report Source
Product Role Manufacturer Route
Dose Duration
Hospitalization
- Amenorrhoea Nos Health Depo-Provera PS INTRAMUSCULAR 150MG- 1
Initial or
Prolonged Anxiety Nec Professional
DOSE; IM
Disability Borderline Personality Xanax C
Other Disorder
Depression Nos
Drug Withdrawal
Syndrome
Lethargy
Mood Swings
Panic Attack
Date:
01/14/98 ISR Number: 3016733-8 Report Type: Expedited (15-Day) Company Report # 4237/11839 Age:38 YR Gender: Male I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Life-Threatening Cerebral Infarction Foreign Provera PS ORAL 600MG/DAY;ORA
Hospitalization
- Coma Health
L 2 YR
Initial or
Prolonged Haemorrhagic Stroke Professional Doxifluridine C
Headache Nos Company
Epirubicin Hcl C
Nausea Representative Fluorouracil C
Visual Acuity Reduced
Vomiting Nos
Date: 01/14/98 ISR Number: 3016738-7 Report Type: Expedited (15-Day) Company Report # 10265/20246 Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Injection Site Abscess Foreign Depo-Provera PS IM
Initial or
Prolonged
Health
Professional
Company
Representative
Date:
01/15/98 ISR Number: 3016322-5 Report Type: Expedited (15-Day) Company Report # 8-97315-006R Age:62 YR Gender: Female I/FU:
F
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Hospitalization
- Colitis Ischaemic Health Prempro PS ORAL 1 TABLET ONCE
Initial or
Prolonged
Professional DAILY
ORAL
Other
Betapace C
Date:
01/15/98 ISR Number: 3018780-9 Report Type: Direct Company Report # Age:76 YR
Gender: Female I/FU:
I
Outcome PT
Life-Threatening Burning Sensation Nos
Dizziness (Excl
Vertigo)
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Erythema
Hypertension Nos
Malaise Report Source Product Role Manufacturer Route Dose
Duration
Nausea
Prempro PS W Ayerst Lab ORAL 1
A DAY- ORAL
Vision Blurred
Vomiting Nos
Date:
01/20/98 ISR Number: 3016265-7 Report Type: Expedited (15-Day) Company Report # 8-98014-002R Age:49 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Death Brain Stem Infarction Foreign Premelle PS ORAL 1 TABLET ONCE
Hospitalization
- Cerebral Artery Health
DAILY ORAL
Initial or
Prolonged Thrombosis Professional
Loss Of Consciousness
Thrombotic Stroke
Date:
01/20/98 ISR Number: 3017341-5 Report Type: Expedited (15-Day) Company Report # 2479/12541 Age:46 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Death Pulmonary Embolism Consumer Depo-Provera
PS INTRAMUSCULAR IM
Date:
01/20/98 ISR Number: 3017357-9 Report Type: Expedited (15-Day) Company Report # 9967/20246 Age:29 YR Gender: Female I/FU:
F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Death Cardio-Respiratory
Arrest Health Depo-Provera PS 150MG -
Life-Threatening Cardiogenic Shock Professional
1Q3MO;IM
Hospitalization
- Coagulation Disorder Nos Company Advil C
Initial or Prolonged Condition Aggravated Representative Tylenol C
Required Convulsions Nos
Intervention
to Depressed Level Of
Prevent
Permanent Consciousness
Impairment/Damage Electroencephalogram
Abnormal
Electrolyte Imbalance
Epistaxis
Gallbladder Disorder
Nos
Haemorrhage Nos
Hepatic Cirrhosis Nos
Hepatic Disorder Nos
Hepatic Failure
Hepatic Necrosis
Hepatitis B Antibody
Positive
Hypokalaemia
Hypoxia
Jaundice Cholestatic
Nephropathy Nos
Oedema Nos
Weakness
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Date:
01/20/98 ISR Number: 3017361-0 Report Type: Expedited (15-Day) Company Report # 10279/20246 Age:16 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Psychotic Disorder Nos Health Depo-Provera PS INTRAMUSCULAR 150 MG 1 DOSE
Initial or
Prolonged
Professional
IM
Company
Representative
Date:
01/20/98 ISR Number: 3017383-X Report Type: Expedited (15-Day) Company Report # 4190/11839 Age:54 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Haemorrhagic Stroke Consumer Provera
PS
ORAL ORAL
Initial or
Prolonged Hypoaesthesia Company Estrace SS ORAL ORAL
Other Pain Nos Representative
Date:
01/20/98 ISR Number: 3248540-5 Report Type: Periodic Company Report # 90606 Age:57 YR
Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Heart Rate Increased Health Posicor (Mibefradil)
Professional 50.000
Mg PS ORAL 50.0000 MG
DAILY ORAL
Prempro (Estrogens,
Conjugated/Medroxypr
ogesterone Acetate) SS ORAL ORAL
Date:
01/21/98 ISR Number: 3017773-5 Report Type: Expedited (15-Day) Company Report # 10279/20246 Age:15 YR Gender: Female I/FU:
I
Outcome PT Report Source Product Role Manufacturer
Route Dose Duration
Hospitalization
- Feeling Of Despair Health Depo-Provera PS INTRAMUSCULAR 150
Initial or
Prolonged Psychotic Disorder Nos Professional
MG-1Q13WK;IM
Other Suicide Attempt Company
Representative
Date:
01/26/98 ISR Number: 3019614-9 Report Type: Expedited (15-Day) Company Report # 10323/20246 Age: Gender:
Female I/FU: I
Outcome PT Report Source Product Role
Manufacturer Route Dose Duration
Hospitalization
- Hypersensitivity Nos Foreign Depo-Provera PS INTRAMUSCULAR 150MG -
Initial or
Prolonged Urticaria Nos Health
1DOSE; IM
Other
Professional
Company
Representative
Date:
01/27/98 ISR Number: 3094892-9 Report Type: Periodic Company Report # 8-97356-001R Age:21 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Menometrorrhagia Consumer Alesse-28 PS ORAL 1 TABLET
ONCE
DAILY ORAL
Provera SS 10 DAY
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Date:
01/28/98 ISR Number: 3020775-6 Report Type: Expedited (15-Day) Company Report # 10265-20246 Age:24 YR Gender: Female I/FU:
F
Outcome PT Report Source Product
Role Manufacturer Route
Dose Duration
Hospitalization
- Injection Site Abscess Foreign Depo-Provera PS INTRAMUSCULAR 150
Initial or
Prolonged Injection Site Health MG-1Q13WK;IM
Inflammation Professional
Company
Representative
Date:
01/28/98 ISR Number: 3020778-1 Report Type: Expedited (15-Day) Company Report # 10355/20246 Age:15 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Immunocomplex Mediated Health Depo-Provera PS 150 MG 1 DOSE
Initial or
Prolonged Hypersensitivity Professional
IM
Oedema Upper Limb Company
Pain In Limb Representative
Date:
01/28/98 ISR Number: 3020799-9 Report Type: Expedited (15-Day) Company Report # 4256/11839 Age: Gender:
Female I/FU: I
Outcome PT Report Source Product Role
Manufacturer Route Dose Duration
Alopecia Foreign Provera PS ORAL OD-100 MG
Depression Nos Health
12Q1MO; ORAL
Malaise Professional
Medication Error Company
Weight Increased Representative
Date:
01/28/98 ISR Number: 3021090-7 Report Type: Expedited (15-Day) Company Report # 8-98022-020N Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Myocardial Infarction Consumer Premarin
PS ORAL ORAL
Initial or
Prolonged
Provera SS ORAL ORAL
Aspirin C
Date:
01/29/98 ISR Number: 3110610-X Report Type: Expedited (15-Day) Company Report # 8-97287-002R Age:51 YR Gender: Female I/FU:
F
Outcome PT Report Source
Product Role Manufacturer Route
Dose Duration
Hospitalization
- Haematuria Health Prempro PS ORAL
1 TABLET ONCE
Initial or
Prolonged Raynaud'S Phenomenon Professional
DAILY ORAL
Required Skin Discolouration Diflucan C
Intervention
to
Prevent
Permanent
Impairment/Damage
Date:
01/29/98 ISR Number: 3110618-4 Report Type: Expedited (15-Day) Company Report # 8-98084-024A Age:50 YR Gender: Female I/FU:
F
Outcome PT
Hospitalization
- Depression Nos
Initial or
Prolonged Dizziness (Excl Vertigo)
Hypertension Nos
Libido Decreased
Menorrhagia
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Ovarian Cyst
Panic Attack
Photopsia Report Source Product Role
Manufacturer Route Dose Duration
Vision Abnormal
Nos Health Prempro PS ORAL 1 TABLET ONCE
Professional
DAILY ORAL
Date:
01/29/98 ISR Number: 3112086-5 Report Type: Periodic Company Report # 8-97197-024L Age:43 YR Gender: Female I/FU:
F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Galactorrhoea Health Redux
PS
ORAL 30 MG DAILY
Professional
ORAL
Depo
Provera SS INTRAMUSCULAR 400 MG IM
Date:
01/29/98 ISR Number: 3114666-X Report Type: Periodic Company Report # 8-97017-006L Age:43 YR Gender: Female I/FU:
F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Demyelination Nos Health
Redux PS ORAL 15-30 MG
Diplopia Professional
DAILY ORAL
Eye Movement Disorder
Nos
Prempro SS ORAL 1 DAILY ORAL
Hypoaesthesia
Synthroid C
Meningioma
Motrin C
Muscle Twitching
Nystagmus Nos
Optic Ischaemic
Neuropathy
Date:
02/02/98 ISR Number: 3021907-6 Report Type: Expedited (15-Day) Company Report # 6542/20246 Age:23 YR Gender: Female I/FU:
F
Outcome PT Report Source Product Role
Manufacturer Route Dose Duration
Hospitalization
- Appetite Decreased Nos Consumer Depo-Provera
PS 150MG-1Q3MO;I
Initial or
Prolonged Blood Creatine
M
Other Phosphokinase Mb
Increased
Difficulty In Walking
Medication Error
Muscle Weakness Nos
Myopathy
Pain Nos
Rhabdomyolysis
Weight Decreased
Date:
02/02/98 ISR Number: 3021909-X Report Type: Expedited (15-Day) Company Report # 10279/20246 Age:15 YR Gender: Female I/FU:
F
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Hospitalization
- Psychotic Disorder Nos Health Depo-Provera PS INTRAMUSCULAR 150 MG-1Q
Initial or
Prolonged Suicide Attempt Professional 13WK;
IM
Other
Company
Representative
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Date:
02/02/98 ISR Number: 3022335-X Report Type: Expedited (15-Day) Company Report # 7614/20246 Age:28 YR Gender: Female I/FU:
F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Anxiety Nec
Depo-Provera PS 150
MG- 1
Initial or
Prolonged Atrial Tachycardia
DOSE; IM
Disability Depression Nos
Other Fatigue
Irritable Bowel
Syndrome
Mitral Valve Disease
Nos
Nausea
Palpitations
Peptic Ulcer
Tachycardia Nos
Uterine Haemorrhage
Vomiting Nos
Date:
02/02/98 ISR Number: 3022613-4 Report Type: Expedited (15-Day) Company Report # 10196/20246 Age:23 YR Gender: Female I/FU:
F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Abdominal Pain Nos Health Depo-Provera PS INTRAMUSCULAR 150 MG -
Acne Nos Professional
1DOSE; IM
Alopecia Company
Back Pain Representative
Chest Pain
Convulsions Nos
Depression Nos
Diarrhoea Nos
Fatigue
Haemorrhage Nos
Headache Nos
Intermenstrual
Bleeding
Muscle Cramps
Myalgia
Nervousness
Panic Attack
Syncope
Visual Field Defect
Nos
Vomiting Nos
Weight Decreased
Date:
02/03/98 ISR Number: 3139478-2 Report Type: Periodic Company Report # 8-98034-017N Age:68 YR
Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Breast Pain Consumer Prempro PS ORAL 1 TABLET ONCE
DAILY ORAL
Vitamins C
Date:
02/04/98 ISR Number: 3022635-3 Report Type: Expedited (15-Day) Company Report # 4125/11839 Age:1 DY Gender: Male I/FU:
F
Outcome PT
Death Abnormal Palmar/Plantar
Hospitalization
- Creases
Initial or
Prolonged Akinesia
Disability Blindness Nos
Congenital
Anomaly Cataract Nos
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Complications Of
Maternal
Exposure To
Therapeutic
Drugs Report Source Product
Role Manufacturer Route Dose
Duration
Congenital Cardiac
Septal Consumer Provera PS ORAL ORAL
Defect Nos Company
Congenital
Clubfoot Representative
Congenital Infection
Nos
Congenital Joint
Malformation Nos
Congenital
Musculoskeletal
Abnormality Nos
Congenital Nose
Malformation Nos
Cryptorchism
Developmental Delay
Nos
Dysphagia
Facial Dysmorphism
Finger Deformity Nos
Genitalia External
Ambiguous
Hearing Impaired
Microcephaly
Microphthalmos
Multiple Congenital
Abnormalities
Neonatal Disorder Nos
Oesophageal Atresia
Posture Abnormal
Small For Dates Baby
Trismus
Date:
02/04/98 ISR Number: 3022651-1 Report Type: Expedited (15-Day) Company Report # 10382/20246 Age: Gender:
I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Death Abortion Spontaneous Health
Depo-Provera PS
150MG/DAY; IM
Life-Threatening Complete Nos Professional
Drug Ineffective
Date:
02/09/98 ISR Number: 3026076-4 Report Type: Expedited (15-Day) Company Report # 10349/20246 Age: Gender:
I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Death Abortion Spontaneous
Nos Foreign Depo-Provera PS INTRAMUSCULAR 150
Pelvic Pain Nos Health
MG/ML-1Q12WK;
Professional
IM
Company
Representative
Date:
02/09/98 ISR Number: 3026079-X Report Type: Expedited (15-Day) Company Report # 4264/11839 Age: Gender:
Female I/FU: I
Outcome PT Report Source
Congenital
Anomaly Unevaluable Reaction Foreign
Health
Professional
Company
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Representative
Product Role Manufacturer Route
Dose Duration
Provera PS ORAL ORAL
10 WK
Date:
02/09/98 ISR Number: 3026416-6 Report Type: Expedited (15-Day) Company Report # 8-98036-001R Age:68 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Adenocarcinoma Nos Health Prempro PS ORAL 1 TABLET ONCE
Initial or
Prolonged Intermenstrual
Bleeding Professional
DAILY ORAL
Other
Date:
02/12/98 ISR Number: 3039128-X Report Type: Expedited (15-Day) Company Report # 8-97363-005R Age:54 YR Gender: Female I/FU:
I
Outcome PT Report Source Product Role
Manufacturer Route Dose Duration
Hospitalization
- Abdominal Pain Nos Consumer Prempro
PS
ORAL 1 TABLET ONCE
Initial or
Prolonged Cholelithiasis
DAILY ORAL
Other
Date:
02/13/98 ISR Number: 3030276-7 Report Type: Expedited (15-Day) Company Report # 8-97322-008N Age:44 YR Gender: Female I/FU:
F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Abdominal Pain Nos Health
Prempro PS ORAL 1 TABLET ONCE
Initial or
Prolonged Abdominal Pain Upper Professional
DAILY ORAL
Other Cholelithiasis
Imitrex C
Diarrhoea Nos
Migraine C
Liver Function Tests
Nos Imitrex C
Abnormal
Nausea
Vomiting Nos
Date:
02/17/98 ISR Number: 3030744-8 Report Type: Expedited (15-Day) Company Report # 6542/20246 Age:23 YR Gender: Female I/FU:
F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Appetite Decreased Nos Consumer Depo-Provera
PS
INTRAMUSCULAR 150 MG-1Q3MO;
Initial or
Prolonged Blood Creatine
IM
Other Phosphokinase Increased
Difficulty In Walking
Injection Site Pain
Medication Error
Muscle Stiffness
Muscle Weakness Nos
Pain In Limb
Rhabdomyolysis
Weight Decreased
Date:
02/18/98 ISR Number: 3036429-6 Report Type: Direct Company Report # Age:37 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Urticaria Nos Depo Provera PS INTRAMUSCULAR IM 150 MGM
Q90D
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Date:
02/19/98 ISR Number: 3031877-2 Report Type: Expedited (15-Day) Company Report # 10455/20246 Age:30 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Akinesia Foreign Depo-Provera PS INTRAMUSCULAR 150MG-1Q12WK;
Initial or
Prolonged Depression Aggravated Health
IM
Muscle Rigidity Professional Psycho-Active Drugs
SS
Parkinsonism Company
Tremor Representative
Date:
02/23/98 ISR Number: 3034775-3 Report Type: Expedited (15-Day) Company Report # 4267/11839 Age:52 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Arrhythmia Nos Foreign Provera PS ORAL 15-300
Initial or
Prolonged Dyspnoea Nos Health MG/DAY/ORAL
Lethargy Professional
Weight Increased Company
Representative
Date:
02/23/98 ISR Number: 3034779-0 Report Type: Expedited (15-Day) Company Report # 10382/20246 Age: Gender:
I/FU: F
Outcome PT Report Source Product Role Manufacturer
Route Dose Duration
Death Abortion Spontaneous
Nos Health Depo-Provera PS INTRAMUSCULAR 150 MG/DAY;
Life-Threatening Drug Ineffective Professional
IM
Date:
02/23/98 ISR Number: 3036312-6 Report Type: Expedited (15-Day) Company Report # 4265/11839 Age:48 YR
Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Cardiac Failure Nos Foreign Provera PS ORAL ORAL
Initial or
Prolonged Cardiac Tamponade Health Doxifluridine C
Other Chest Pain Professional
Leuprorelin Acetate C
Pleural Effusion Company Cyclophosphamide C
Representative Tamoxifen
Citrate C
Date:
02/23/98 ISR Number: 3036437-5 Report Type: Expedited (15-Day) Company Report # M076321 Age:60 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Vaginal Discharge Consumer Estrace PS NI
Initial or
Prolonged Premarin SS ORAL 0.625MG OD
ORAL
Provera SS
Date:
02/23/98 ISR Number: 3036445-4 Report Type: Expedited (15-Day) Company Report # 4266/11839 Age:60 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Adenocarcinoma Nos Foreign Provera PS ORAL 200MG
Initial or
Prolonged Endometriosis Literature
-1Q1DY;ORAL
Other Health Royal Jelly ( Health
Required
Professional Food ) SS
Intervention
to
Company
Propolis SS
(Health Food)
Prevent
Permanent
Representative
Impairment/Damage
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Date:
02/23/98 ISR Number: 3036863-4
Report Type: Direct
Company Report #
Age:68 YR Gender: Female
I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Endometrial Cancer Nos Prempro PS ORAL 1 DAILY
Intermenstrual
Bleeding
Date:
02/23/98 ISR Number: 3036865-8 Report Type: Direct Company Report # Age:60 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer
Route Dose Duration
Abdominal Pain
Lower Health Prempro PS ORAL 1 DAILY
Endometrial Cancer
Nos Professional
Intermenstrual
Bleeding
Date:
02/26/98 ISR Number: 3037089-0 Report Type: Expedited (15-Day) Company Report # 8-98050-008R Age:44 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Stevens Johnson Syndrome Foreign Premique PS ORAL 1 TABLET ONCE
Initial or
Prolonged Urticaria Nos Health
DAILY ORAL
Professional Windcheaters SS ORAL 2 TABLETS 1
TIME ORAL
Date:
02/26/98 ISR Number: 3037092-0 Report Type: Expedited (15-Day) Company Report # 8-98022-020N Age: Gender:
Female I/FU: F
Outcome PT Report Source Product Role
Manufacturer Route Dose Duration
Hospitalization
- Myocardial Infarction Consumer Premarin
PS
ORAL ORAL
Initial or
Prolonged Provera SS ORAL ORAL
Aspirin C
Date:
02/26/98 ISR Number: 3037094-4 Report Type: Expedited (15-Day) Company Report # 8-95277-013A Age:58 YR Gender: Female I/FU:
F
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Life-Threatening Chest Pain Consumer Premarin
PS
ORAL 0.625 MG ONCE
Hospitalization
- Medication Error DAILY
ORAL
Initial or
Prolonged Myocardial Infarction
TAB
Other Upper Respiratory
Tract
Phenergan Vc With
Required Infection Nos
Codeine SS ORAL 2 TSP Q 6
Intervention
to HOURS
ORAL
Prevent
Permanent
Provera SS CYCLICALLY
Impairment/Damage
OR DAILY
Lorabid C
Provera Cyclic C
Date:
02/26/98 ISR Number: 3043837-6 Report Type: Expedited (15-Day) Company Report # 10455/20246 Age:30 YR Gender: Female I/FU:
F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Akinesia Foreign Depo-Provera
PS
INTRAMUSCULAR 150 MG - 1
Initial or
Prolonged Depression Aggravated Health
DOSE; IM
Other Muscle Rigidity
Professional Psycho
Active Drugs C
Parkinsonism Company
Tremor Representative
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Date:
02/26/98 ISR Number: 3043841-8 Report Type: Expedited (15-Day) Company Report # 9987/20246 Age: Gender:
Male I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Complications Of Maternal Health Depo-Provera PS INTRAMUSCULAR 1 DOSE; IM
Initial or
Prolonged Exposure To
Therapeutic Professional Unspecified Oral
Congenital
Anomaly Drugs
Contraceptive SS
Congenital Limb Anomaly
Nos
Date:
02/27/98 ISR Number: 3037642-4 Report Type: Expedited (15-Day) Company Report # 8-98050-009R Age:51 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Haemorrhagic Stroke Consumer Prempro
PS ORAL 1 TABLET ONCE
Initial or
Prolonged Loss Of Consciousness
DAILY ORAL
Oedema Lower Limb
Platelet Count Abnormal
Polymenorrhoea
Pulmonary Embolism
Thrombocythaemia
Venous Thrombosis Deep
Limb
Date:
02/27/98 ISR Number: 3043984-9 Report Type: Direct Company Report # Age:61 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Hypoaesthesia
Premarin PS
0.625 Q 2-3
Pain Nos DAY
Provera SS
2.5MG Q2 DAY
Doxepin C
Date:
03/02/98 ISR Number: 3129342-7 Report Type: Periodic Company Report # 9718577 Age:54 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Breast Pain Health Zoloft PS ORAL ORAL
Menometrorrhagia Professional Prempro SS ORAL 1.00
Menstrual Disorder
Nos TOTAL:DAILY:O
RAL
Synthroid C
Ginkgo Biloba C
Calcium With
Magnesium C
Vitamin C With Rose
Hips C
Vitamin E C
Date:
03/02/98 ISR Number: 3147142-9 Report Type: Periodic Company Report # 9706180 Age:52 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Amnesia
Health Zoloft PS ORAL TABLETS,
Anxiety Nec Professional 50.00 MG
Dizziness (Excl
Vertigo)
TOTAL:DAILY:O
Weight Decreased RAL
Prempro SS ORAL ORAL
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Date:
03/03/98 ISR Number: 3040078-3 Report Type: Expedited (15-Day) Company Report # 8-98054-001R Age:60 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Endometrial Cancer Nos Health Prempro
PS ORAL 1 TABLET ONCE
Intermenstrual
Bleeding Professional
DAILY ORAL
Muscle Cramps
Date:
03/03/98 ISR Number: 3040106-5 Report Type: Expedited (15-Day) Company Report # 8-98054-002R Age:68 YR Gender: Female I/FU:
I
Outcome PT Report Source Product Role
Manufacturer Route Dose Duration
Hospitalization
- Endometrial Cancer Nos Health Prempro PS ORAL 1 TABLET ONCE
Initial or
Prolonged Intermenstrual
Bleeding Professional
DAILY ORAL
Other
Date:
03/05/98 ISR Number: 3044349-6 Report Type: Expedited (15-Day) Company Report # 10501/20246 Age:
Gender: Female
I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Death Abortion Spontaneous
Nos Health
Depo-Provera PS INTRAMUSCULAR 150
Drug Ineffective Professional
MG-1Q12WK;IM 1 YR
Pregnancy Nos Company
Representative
Date:
03/05/98 ISR Number: 3044351-4 Report Type: Expedited (15-Day) Company Report # 4275/11839 Age:70 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Autoimmune Hepatitis Foreign
Provera PS ORAL 200
Initial or
Prolonged Hepatic Function
Abnormal Health
MG-2Q1DY;ORAL
Other Nos Professional Flurouracil SS
Jaundice Nos Company Radiotherapy C
Nausea Representative
Vomiting Nos
Date:
03/06/98 ISR Number: 3043944-8 Report Type: Expedited (15-Day) Company Report # 8-98013-005R Age:61 YR Gender: Female I/FU:
F
Outcome PT Report Source
Product Role Manufacturer Route
Dose Duration
Hospitalization
- Cervical Discharge Health Premarin PS ORAL
0.625 MG ONCE
Initial or
Prolonged Uterine Sarcoma Nos Professional
DAILY ORAL
Other
Estrace SS
Provera SS 10
MG
Date:
03/06/98 ISR Number: 3048899-8 Report Type: Expedited (15-Day) Company Report # 9804171 Age: Gender:
Female I/FU: I
Outcome PT
Required Angioneurotic Oedema
Intervention
to Blood Alkaline
Prevent
Permanent Phosphatase Nos
Increased
Impairment/Damage Dyspepsia
Dyspnoea Nos
Face Oedema
Haemochromatosis
Oedema Lower Limb
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Pruritus Nos
Serum Ferritin
Increased
Tongue Oedema Report Source Product Role
Manufacturer Route Dose
Duration
Urticaria Nos Consumer Zithromax PS ORAL 500.00 MG
Vaginitis TOTAL
DAILY
ORAL
Prempro SS ORAL ORAL
Lasix SS ORAL ORAL
Motrin C
Elavil C
Klonopin C
Date:
03/09/98 ISR Number: 3049388-7 Report Type: Expedited (15-Day) Company Report # 10524/20246 Age:39 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Agitation Foreign Depo-Provera PS 150 MG 1 DOSE
Initial or
Prolonged Anxiety Nec Health
IM
Other Confusion Professional Mylepsine
C
Delusion Nos Company
Libido Increased Representative
Date:
03/09/98 ISR Number: 3049392-9 Report Type: Expedited (15-Day) Company Report # 10522/20246 Age: Gender:
I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Death Abortion Spontaneous Nos
Health
Depo-Provera PS 150
MG- 1Q
Drug Ineffective Professional 12WK; IM
Company
Representative
Date:
03/09/98 ISR Number: 3051635-2 Report Type: Expedited (15-Day) Company Report # 1603/11839 Age:1 DY Gender: Female I/FU:
F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Congenital
Anomaly Complications Of
Maternal Consumer Provera PS ORAL ORAL
Exposure To
Therapeutic
Ampicillin SS 3000
Drugs
MG/DAY;IV;ORA
Congenital
Abnormality
L
Nos
Developmental Delay
Nos
Precocious Puberty Nos
Date:
03/11/98 ISR Number: 3056008-4 Report Type: Expedited (15-Day) Company Report # 8-97356-002R Age: Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Uterine Cancer Nos Consumer Prempro
PS
ORAL 1 TABLET ONCE
Initial or
Prolonged
DAILY
Other
Premarin SS ORAL 10 YR
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Date:
03/12/98 ISR Number: 3058541-8 Report Type: Direct Company Report # Age:24 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Dizziness (Excl
Vertigo)
Depo-Provera PS
Upjohn
INTRAMUSCULAR 150 IM R
Ecchymosis
DELTOID
Hypoaesthesia
Oedema Upper Limb
Pain Nos
Pruritus Nos
Date:
03/12/98 ISR Number: 3059180-5 Report Type: Direct Company Report # Age:68 YR Gender:
Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Breast Lump Nos Consumer Cycrin PS Esi
Lederle ORAL MON. WED.
Nipple Exudate
Bloody
FRI. X I
Skin Nodule
MONTH
Date:
03/12/98 ISR Number: 3139444-7 Report Type: Periodic Company Report # 8-98033-012N Age:52 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Insomnia Consumer Prempro
PS
ORAL 1 TABLET ONCE
Palpitations
DAILY ORAL
Date: 03/16/98 ISR Number: 3056210-1 Report Type: Expedited (15-Day) Company Report # 2488/12541 Age:30 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Dyspnoea Nos Foreign Depo-Provera PS INTRAMUSCULAR 150MG 1
Initial or
Prolonged Muscle Spasms Health
DOSE;IM
Other Nausea Professional
Sweating
Increased Company
Vomiting Nos
Representative
Date:
03/16/98 ISR Number: 3056213-7 Report Type: Expedited (15-Day) Company Report # 10539/20246 Age: Gender:
Female I/FU: I
Outcome PT Report Source
Product Role Manufacturer Route
Dose Duration
Congenital
Anomaly Cardiac Murmur Nos Consumer Depo-Provera
PS
INTRAMUSCULAR 150 MG
Cleft Palate Company
1Q13WK;IM
Complications Of
Maternal Representative
Exposure To Therapeutic
Drugs
Ear Malformation Nos
Hearing Impaired
Inflammation Nos
Multiple Congenital
Abnormalities
Pregnancy Nos
Smear Cervix Abnormal
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Date:
03/16/98 ISR Number: 3057417-X Report Type: Expedited (15-Day) Company Report # 10532/20246 Age:15 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route
Dose Duration
Disability Arthralgia Health Depo-Provera PS INTRAMUSCULAR 150 MG-1
Other Disability Nos Professional
DOSE; IM
Dizziness (Excl
Vertigo) Company
Fatigue Representative
Nausea
Pyrexia
Rash Pruritic
Date:
03/16/98 ISR Number: 3057496-X Report Type: Expedited (15-Day) Company Report # 8-97156-004R Age:48 YR Gender: Female I/FU:
F
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Abdominal Pain Nos Health Premphase PS
ORAL 1 TABLET ONCE
Initial or
Prolonged Burning Sensation Nos Professional
DAILY ORAL
Required Dizziness (Excl Vertigo) Biaxin
C
Intervention
to Feeling Hot
Steroid Dose Pack C
Prevent
Permanent Headache Nos
Claritin Prn C
Impairment/Damage
Hypoaesthesia
Nausea
Palpitations
Weakness
Date:
03/16/98 ISR Number: 3134825-X Report Type: Periodic Company Report # 8-97335-003N Age:66 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Disability Vision Abnormal Nos Consumer Prempro
PS
ORAL 1 TABLET ONCE
DAILY ORAL
Date:
03/16/98 ISR Number: 3134826-1 Report Type: Periodic Company Report #
8-97350-009R Age: Gender: Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Paraesthesia Consumer Premphase PS ORAL 1 TABLET ONCE
Required Phlebitis Nos
DAILY ORAL
Intervention
to
Premarin SS ORAL ORAL
Prevent
Permanent
Impairment/Damage
Date:
03/16/98 ISR Number: 3134827-3 Report Type: Periodic Company Report # 8-97350-010R Age:49 YR Gender: Female I/FU:
I
Outcome PT Report Source
Product Role Manufacturer Route
Dose Duration
Hospitalization
- Menometrorrhagia Consumer Premphase PS ORAL 1 TABLET ONCE
Initial or
Prolonged
DAILY ORAL
Date:
03/16/98 ISR Number: 3134828-5 Report Type: Periodic Company Report #
8-98006-005R Age:62 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Hypertension Nos Consumer Prempro PS ORAL 1 TABLET ONCE
Initial or
Prolonged Pulmonary Embolism DAILY ORAL
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Date:
03/16/98 ISR Number: 3134829-7 Report Type: Periodic Company Report #
8-98013-003R Age:49 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Hospitalization
- Breast Cancer Female Nos Consumer Premphase
PS
ORAL 1 TABLET ONCE
Initial or
Prolonged
DAILY ORAL
Other
Prempro SS ORAL 1 TABLET ONCE
DAILY
ORAL
Synthroid C
Prempro C
Date:
03/16/98 ISR Number: 3134831-5 Report Type: Periodic Company Report # 8-98020-003R Age:57 YR Gender: Female I/FU:
I
Outcome PT Report Source
Product Role Manufacturer Route
Dose Duration
Hospitalization
- Pulmonary Embolism Consumer Prempro 0.625 Mg/2.5
Initial or
Prolonged Mg PS ORAL 1 TABLET ONCE
DAILY ORAL
Date:
03/16/98 ISR Number: 3134833-9 Report Type: Periodic Company Report # 8-97364-002R Age: Gender:
Female I/FU: I
Outcome PT Report Source Product Role Manufacturer
Route Dose Duration
Other Drug Interaction Nos Health Prempro PS ORAL 1 TABLET ONCE
Vasodilatation
Professional
DAILY ORAL
Company Prozac SS
Representative
Date:
03/16/98 ISR Number: 3134834-0 Report Type: Periodic Company Report # 8-97364-003R Age:70 YR Gender: Female I/FU:
I
Outcome PT Report Source
Product Role Manufacturer Route
Dose Duration
Other Breast Pain Consumer Prempro 0.625 Mg/2.5
Menometrorrhagia Mg PS ORAL 1 TABLET ONCE
Skin
Discolouration
DAILY ORAL
Mevacor C
Multi-Vitamins C
Atrovent
Inhaler C
Date:
03/16/98 ISR Number: 3134836-4 Report Type: Periodic Company Report # 8-98002-002R Age:64 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Menometrorrhagia Health Prempro PS ORAL 1 TABLET
ONCE
Professional
DAILY ORAL
Date:
03/16/98 ISR Number: 3134840-6 Report Type: Periodic Company Report #
8-98002-004R Age:39 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Alopecia Consumer Prempro PS ORAL 1 TABLET ONCE
DAILY ORAL
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Date:
03/16/98 ISR Number: 3134841-8 Report Type: Periodic Company Report #
8-98002-005R Age:50 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Menometrorrhagia Health Prempro PS ORAL 1 TABLET ONCE
Vaginal Discharge Professional DAILY ORAL
Calcium C
Vitamins C
Date:
03/16/98 ISR Number: 3134843-1 Report Type: Periodic Company Report # 8-98006-001R Age:46 YR Gender: Female I/FU:
I
Outcome PT Report Source Product Role
Manufacturer Route Dose Duration
Other Alopecia Consumer Premphase PS ORAL 1 TABLET ONCE
Dermatitis Nos
DAILY ORAL
Vaginitis
Date:
03/16/98 ISR Number: 3134844-3 Report Type: Periodic Company Report #
8-98006-002R Age:73 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Asthenia
Consumer
Prempro PS ORAL 1 TABLET ONCE
Breast Pain
DAILY
ORAL
Flatulence
Date:
03/16/98 ISR Number: 3134846-7 Report Type: Periodic Company Report # 8-98006-003R Age:61 YR Gender: Female I/FU:
I
Outcome PT
Report Source
Product Role Manufacturer Route
Dose Duration
Other Emotional Disturbance
Nos Consumer Premphase PS ORAL
1 TABLET ONCE
Hostility
DAILY ORAL
Hypertonia
Date:
03/16/98 ISR Number: 3134847-9 Report Type: Periodic Company Report #
8-98006-004R Age:72 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Menometrorrhagia Consumer Prempro 0.625 Mg/2.5
Mg PS ORAL
1 TABLET ONCE
DAILY ORAL
Date:
03/16/98 ISR Number: 3134849-2 Report Type: Periodic Company Report #
8-98006-006R Age:51 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Flatulence Consumer Prempro 0.625 Mg/2.5
Mg PS ORAL 1 TABLET ONCE
DAILY ORAL
Date:
03/16/98 ISR Number: 3134850-9 Report Type: Periodic Company Report #
8-98006-007R Age:73 YR Gender:
Female I/FU: I
Outcome PT
Other Abdominal Distension
Asthenopia
Condition Aggravated
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Dizziness (Excl
Vertigo)
Dysgeusia
Feeling Jittery Report Source Product
Role Manufacturer Route Dose
Duration
Fluid Retention Consumer Prempro PS ORAL 1 TABLET ONCE
Hiatus Hernia
DAILY ORAL
Nervousness
Hydrochlorothiazide C
Oesophageal Stenosis Calcium C
Vitamin C
Date:
03/16/98 ISR Number: 3134851-0 Report Type: Periodic Company Report #
8-98006-008R Age:53 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Menometrorrhagia Consumer Prempro PS ORAL 1 TABLET ONCE
DAILY ORAL
Coumadin C
Betatrase C
Date:
03/16/98 ISR Number: 3134852-2 Report Type: Periodic Company Report # 8-98007-002R Age: Gender:
Female I/FU: I
Outcome PT Report Source Product Role
Manufacturer Route Dose Duration
Other Abdominal Pain Nos Consumer Prempro
PS
ORAL 1 TABLET ONCE
Breast Enlargement
DAILY ORAL
Menometrorrhagia
Date:
03/16/98 ISR Number: 3134855-8 Report Type: Periodic Company Report #
8-98016-008N Age: Gender: Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Menometrorrhagia Health
Prempro PS ORAL 1 TABLET ONCE
Professional DAILY ORAL
Company
Representative
Date:
03/16/98 ISR Number: 3134857-1 Report Type: Periodic Company Report #
8-98016-010N Age:50 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Alopecia Health Prempro PS ORAL 1 TABLET ONCE
Professional DAILY ORAL
Redux SS ORAL ORAL
Redux Capsules Oral C
Date:
03/16/98 ISR Number: 3134858-3 Report Type: Periodic Company Report # 8-98016-015N Age:76 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Dermatitis Nos Health Prempro PS ORAL 1 TABLET ONCE
Oedema Nos Professional
DAILY ORAL
Pruritus Nos
Prilosec C
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Date:
03/16/98 ISR Number: 3134859-5 Report Type: Periodic Company Report # 8-98020-007N Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Menometrorrhagia Health
Prempro PS ORAL 1 TABLET ONCE
Professional
DAILY ORAL
Company
Representative
Date:
03/16/98 ISR Number: 3134861-3 Report Type: Periodic Company Report # 8-98021-001R Age:74 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Menometrorrhagia Consumer
Prempro PS ORAL 1 TABLET ONCE
DAILY ORAL
Lopid C
Date:
03/16/98 ISR Number: 3134863-7 Report Type: Periodic Company Report # 8-98022-018N Age:60 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Abdominal Pain Nos Consumer Prempro PS ORAL 1 TABLET ONCE
Breast
Enlargement
DAILY ORAL
Breast Pain Aspirin C
Menometrorrhagia
Plendil C
Oedema Nos
Date:
03/16/98 ISR Number: 3134866-2 Report Type: Periodic Company Report #
8-98023-004N Age:51 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Migraine Nos Consumer Prempro PS ORAL 1 TABLET ONCE
DAILY
ORAL
Date:
03/16/98 ISR Number: 3134868-6 Report Type: Periodic Company Report # 8-98023-005N Age:68 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Breast Enlargement Consumer Prempro
PS ORAL 1 TABLET ONCE
Breast Pain
DAILY ORAL
Menometrorrhagia Levothyroid C
Weight Increased
Paravachol C
Date:
03/16/98 ISR Number: 3134870-4 Report Type: Periodic Company Report #
8-98023-006N Age:45 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Breast Pain Consumer Prempro PS ORAL 1 TABLET ONCE
Oedema Peripheral
DAILY ORAL
Date:
03/16/98 ISR Number: 3134871-6 Report Type: Periodic Company Report # 8-98023-007N Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Menometrorrhagia Consumer Prempro PS ORAL 1 TABLET ONCE
DAILY ORAL
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Date:
03/16/98 ISR Number: 3134874-1 Report Type: Periodic Company Report # 8-98023-008N Age:58 YR Gender: Female I/FU:
I
Outcome PT Report Source Product Role Manufacturer
Route Dose Duration
Other Back Pain Consumer Prempro PS ORAL 1 TABLET ONCE
Breast Pain
DAILY ORAL
Diarrhoea Nos
Levoxyl C
Dyspepsia
Pain Nos
Date:
03/16/98 ISR Number: 3134876-5 Report Type: Periodic Company Report # 8-98023-009N Age:58 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Breast Pain Consumer Prempro PS ORAL 1
TABLET ONCE
Menometrorrhagia
DAILY ORAL
Pruritus Nos
Vaginal Discharge
Date:
03/16/98 ISR Number: 3134878-9 Report Type: Periodic Company Report # 8-98023-010N Age:76 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Accommodation Disorder Consumer Prempro
PS
ORAL 1 TABLET ONCE
Dizziness (Excl Vertigo)
DAILY ORAL
Headache Nos
Asa C
Hypertension Nos Calcium C
Nausea
Centrum Vitamins C
Pain Nos Herbs: Garlic, Yucca
Vomiting Nos Ar,
Hawthorne Berrie
Dose Varies C
Vitamin E C
Date:
03/16/98 ISR Number: 3134879-0 Report Type: Periodic Company Report # 8-98023-012N Age:38 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Diarrhoea Nos Consumer Prempro PS ORAL 1
TABLET ONCE
DAILY ORAL
Calcium/Magnesium
Supplement C
Klonopin C
Unspecified
Multivitamin Daily C
Date:
03/16/98 ISR Number: 3134881-9 Report Type: Periodic Company Report #
8-98023-014N Age:74 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Dysmenorrhoea
Consumer
Prempro PS ORAL 1 TABLET ONCE
Flatulence
DAILY ORAL
Menometrorrhagia
Prevacid C
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Date:
03/16/98 ISR Number: 3134883-2 Report Type: Periodic Company Report # 8-98023-015N Age:51 YR Gender: Female I/FU:
I
Outcome PT Report Source Product Role Manufacturer
Route Dose Duration
Other Menometrorrhagia Consumer Prempro PS ORAL 1 TABLET ONCE
DAILY
ORAL
Date:
03/16/98 ISR Number: 3134885-6 Report Type: Periodic Company Report # 8-98023-017N Age:47 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Asthenia Consumer
Premphase PS ORAL 1 TABLET ONCE
Colitis Nos
DAILY ORAL
Conjunctivitis
Nos
Synthroid C
Dysgeusia
Vasotec C
Flatulence Xanax C
Nausea
Date:
03/16/98 ISR Number: 3134888-1 Report Type: Periodic Company Report # 8-98023-019N Age:51 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Menometrorrhagia Consumer Prempro PS ORAL 1 TABLET ONCE
DAILY ORAL
Date:
03/16/98 ISR Number: 3134890-X Report Type: Periodic Company Report #
8-98027-003N Age: Gender: Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Constipation Health Prempro PS ORAL 1 TABLET ONCE
Urinary Tract
Disorder Professional DAILY
ORAL
Nos Company
Representative
Date:
03/16/98 ISR Number: 3134891-1 Report Type: Periodic Company Report #
8-98028-004R Age: Gender: Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Endometrial
Hyperplasia Health Prempro PS ORAL ORAL
Professional
Company
Representative
Date:
03/16/98 ISR Number: 3134893-5 Report Type: Periodic Company Report # 8-98028-019N Age:75 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Menometrorrhagia Consumer Prempro
PS
ORAL 1 TABLET ONCE
DAILY ORAL
Ascriptin C
Hyzaar C
Toprol C
Vitamin E C
Zocor C
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Date:
03/16/98 ISR Number: 3139021-8 Report Type: Periodic Company Report # 8-98015-001N Age:67 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Vaginitis Health Prempro PS ORAL 1 TABLET ONCE
Professional
DAILY ORAL
Date:
03/16/98 ISR Number: 3139023-1 Report Type: Periodic Company Report #
8-98015-003N Age:52 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route
Dose Duration
Other Hypersensitivity Nos Consumer Prempro
PS
ORAL 1 TABLET ONCE
DAILY
ORAL
Date:
03/16/98 ISR Number: 3139026-7 Report Type: Periodic Company Report # 8-98015-004N Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Migraine Nos Consumer Prempro PS ORAL 1 TABLET ONCE
DAILY ORAL
Date:
03/16/98 ISR Number: 3139030-9 Report Type: Periodic Company Report #
8-98015-005N Age: Gender: Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route
Dose Duration
Other Menometrorrhagia Consumer Prempro PS ORAL 1 TABLET ONCE
DAILY
ORAL/1
TABLET ONCE
DAILY
Zertec C
Date:
03/16/98 ISR Number: 3139033-4 Report Type: Periodic Company Report #
8-98015-006N Age:73 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Hormone Level Nos Health Prempro PS ORAL 1 TABLET ONCE
Abnormal Professional
DAILY ORAL
Prozac C
Unspecified Thyroid
Medication C
Date:
03/16/98 ISR Number: 3139036-X Report Type: Periodic Company Report #
8-98015-007N Age:54 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Vision Abnormal Nos Consumer Prempro
PS
ORAL 1 TABLET ONCE
DAILY ORAL
Fosamax C
Date:
03/16/98 ISR Number: 3139039-5 Report Type: Periodic Company Report # 8-98015-008N Age:
Gender: Female
I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Tachycardia Nos Health Prempro PS ORAL 1 TABLET ONCE
Professional
DAILY ORAL
Tozicor SS
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Date:
03/16/98 ISR Number: 3139043-7 Report Type: Periodic Company Report #
8-98015-009N Age:55 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route
Dose Duration
Other Endometrial Disorder
Nos Consumer Prempro PS ORAL 1 TABLET ONCE
Menometrorrhagia DAILY
ORAL
Date:
03/16/98 ISR Number: 3139046-2 Report Type: Periodic Company Report # 8-98015-010N Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Chest Pain Consumer Prempro PS ORAL ORAL
18 MON
Pain Nos
Petechiae
Date:
03/16/98 ISR Number: 3139049-8 Report Type: Periodic Company Report # 8-98015-011N Age:53 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Alopecia Consumer Prempro
PS ORAL 1 TABLET ONCE
Oedema Peripheral
DAILY ORAL
Pain Nos
Date:
03/16/98 ISR Number: 3139051-6 Report Type: Periodic Company Report # 8-98015-013N Age:60 YR Gender: Female I/FU:
I
Outcome PT Report Source
Product Role Manufacturer Route
Dose Duration
Other Diabetes Mellitus Nos Consumer Prempro
PS
ORAL 1 TABLET ONCE
Syncope
DAILY ORAL
Humulin Insulin C
Regular Insulin C
Synthroid C
Date:
03/16/98 ISR Number: 3139054-1 Report Type: Periodic Company Report #
8-98015-014N Age:80 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Hirsutism Consumer Prempro PS ORAL 1 TABLET ONCE
DAILY
ORAL
Dyazide C
Mutivitamin C
Thyroid C
Date:
03/16/98 ISR Number: 3139055-3 Report Type: Periodic Company Report # 8-98015-015N Age:47 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Menometrorrhagia Consumer
Prempro PS ORAL 1 TABLET ONCE
DAILY ORAL
Date:
03/16/98 ISR Number: 3139057-7 Report Type: Periodic Company Report # 8-98015-016N Age:75 YR Gender: Female I/FU:
I
Outcome PT Report Source Product Role
Manufacturer Route Dose Duration
Other Capillary Fragility Consumer Prempro
PS
ORAL 1 TABLET ONCE
Increased
DAILY ORAL
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Cordarone C
Fioricet C
Date:
03/16/98 ISR Number: 3139060-7 Report Type: Periodic Company Report #
8-98015-017N Age:63 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Nausea Health Prempro PS ORAL 1 TABLET ONCE
Professional DAILY
ORAL
Date:
03/16/98 ISR Number: 3139063-2 Report Type: Periodic Company Report # 8-98015-018N Age:50 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Flatulence Consumer Prempro PS ORAL 1 TABLET ONCE
Headache Nos
DAILY ORAL
Menometrorrhagia Lasix C
Oedema Nos
Synthroid C
Date:
03/16/98 ISR Number: 3139067-X Report Type: Periodic Company Report # 8-98015-019N Age:58 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Amenorrhoea Nos Consumer Prempro PS ORAL 1 TABLET ONCE
Menometrorrhagia
DAILY ORAL
Date:
03/16/98 ISR Number: 3139069-3 Report Type: Periodic Company Report # 8-98015-020N Age:69 YR Gender: Female I/FU:
I
Outcome PT Report Source Product Role Manufacturer
Route Dose Duration
Other Breast Enlargement Consumer Prempro
PS
ORAL 1 TABLET ONCE
Breast Pain
DAILY ORAL
Osteoporosis Nos Glaucoma
Medication C
Date:
03/16/98 ISR Number: 3139072-3 Report Type: Periodic Company Report #
8-98015-021N Age:47 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Alopecia Consumer Prempro PS ORAL 1 TABLET ONCE
Breast Enlargement
DAILY ORAL
Breast Pain
Flatulence
Nausea
Date:
03/16/98 ISR Number: 3139074-7 Report Type: Periodic Company Report #
8-98015-022N Age: Gender: Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Menometrorrhagia Health Prempro PS ORAL 1 TABLET ONCE
Professional
DAILY ORAL
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Date:
03/16/98 ISR Number: 3139076-0 Report Type: Periodic Company Report #
8-98015-023N Age:67 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Asthenia Consumer Prempro PS ORAL 1 TABLET ONCE
Breast
Enlargement DAILY
ORAL
Breast Pain
Antibiotics
Depression Nos (Unspecified0 SS
Dermatitis Nos
Hygroton C
Dysmenorrhoea
Klonopin C
Insomnia
Vitamins C
Menometrorrhagia
Osteopetrosis
Uterine Cervical
Disorder
Nos
Date:
03/16/98 ISR Number: 3139079-6 Report Type: Periodic Company Report #
8-98015-024N Age:47 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route
Dose Duration
Other Menometrorrhagia Consumer Prempro PS ORAL 1 TABLET ONCE
DAILY
ORAL
Vitamin E SS 100
MG
Date:
03/16/98 ISR Number: 3139087-5 Report Type: Periodic Company Report #
8-98015-026N Age:69 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Breast Pain Consumer Prempro PS ORAL 1 TABLET ONCE
Dysmenorrhoea
DAILY ORAL
Headache Nos
Synthroid C
Oedema Peripheral
Date:
03/16/98 ISR Number: 3139092-9 Report Type: Periodic Company Report # 8-98015-027N Age:55 YR Gender: Female I/FU:
I
Outcome PT Report Source Product Role Manufacturer
Route Dose Duration
Other Alopecia Consumer Prempro PS ORAL 1 TABLET ONCE
DAILY
ORAL
Date:
03/16/98 ISR Number: 3139096-6 Report Type: Periodic Company Report # 8-98015-028N Age:
Gender: I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Multiple Sclerosis Health
Prempro PS ORAL 1 TABLET ONCE
Professional
DAILY ORAL
Date:
03/16/98 ISR Number: 3139099-1 Report Type: Periodic Company Report # 8-98015-029N Age:50 YR Gender: Female I/FU:
I
Outcome PT Report Source Product Role
Manufacturer Route Dose Duration
Other Alopecia Health Prempro PS ORAL 1 TABLET ONCE
Professional
DAILY ORAL
Unspecified Diet
Pills C
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Date:
03/16/98 ISR Number: 3139101-7 Report Type: Periodic Company Report #
8-98015-031N Age:52 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Menometrorrhagia Consumer Prempro PS ORAL 1 TABLET ONCE
DAILY ORAL
Valium C
Date:
03/16/98 ISR Number: 3139104-2 Report Type: Periodic Company Report #
8-98015-032N Age:55 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Menometrorrhagia
Consumer
Prempro PS ORAL 1 TABLET ONCE
DAILY
ORAL
Date:
03/16/98 ISR Number: 3139106-6 Report Type: Periodic Company Report # 8-98015-034N Age:68 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Menometrorrhagia Consumer Prempro PS ORAL 1 TABLET ONCE
DAILY ORAL
Altace C
Asa C
Axid C
Cardene C
Diabeta C
Micro K C
Provachol C
Synthroid C
Vitamin E C
Date:
03/16/98 ISR Number: 3139108-X Report Type: Periodic Company Report # 8-98015-037N Age:73 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Hypertonia Consumer Prempro PS ORAL 1 TABLET ONCE
Pain Nos
DAILY ORAL
Atenolol C
Date:
03/16/98 ISR Number: 3139110-8 Report Type: Periodic Company Report # 8-98015-039N Age:67 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Condition Aggravated Consumer Prempro
PS
ORAL 1 TABLET ONCE
DAILY
ORAL
Synthroid C
Date:
03/16/98 ISR Number: 3139132-7
Report Type: Periodic
Company Report # 8-98015-040N
Age:54 YR Gender: Female
I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Hypoaesthesia Consumer Prempro PS ORAL 1 TABLET ONCE
Pain Nos DAILY
ORAL
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Date:
03/16/98 ISR Number: 3139133-9
Report Type: Periodic
Company Report # 8-98015-041N
Age: Gender: Female
I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Alopecia Consumer Prempro PS ORAL 1 TABLET ONCE
DAILY
ORAL
Date:
03/16/98 ISR Number: 3139134-0 Report Type: Periodic Company Report # 8-98015-042N Age:55 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Condition Aggravated Health Prempro PS ORAL 1 TABLET ONCE
Depression Nos Professional
DAILY ORAL
Emotional Disturbance Nos
Date:
03/16/98 ISR Number: 3139136-4 Report Type: Periodic Company Report # 8-98015-043N Age:66 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Cholecystitis Nos Consumer Prempro PS ORAL 1 TABLET ONCE
Menometrorrhagia
DAILY ORAL
Iron C
Date:
03/16/98 ISR Number: 3139138-8 Report Type: Periodic Company Report # 8-98015-044N Age:67 YR Gender: Female I/FU:
I
Outcome PT Report Source Product Role
Manufacturer Route Dose Duration
Other Breast Pain Consumer Prempro PS ORAL 1 TABLET ONCE
Hypotonia
DAILY ORAL
Vision Abnormal
Nos
Fosamax C
Date:
03/16/98 ISR Number: 3139140-6 Report Type: Periodic Company Report #
8-98028-020N Age:67 YR Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route
Dose Duration
Other Abdominal Pain Nos Consumer Prempro
PS
ORAL 1 TABLET ONCE
Menometrorrhagia DAILY
ORAL
Oedema Peripheral Lasix C
Pain Nos Potassium C
Synthroid C
Date:
03/16/98 ISR Number: 3139142-X Report Type: Periodic Company Report # 8-98015-045N Age:67 YR
Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Menometrorrhagia Consumer
Prempro PS ORAL 1 TABLET ONCE
DAILY ORAL
Provera C
Date:
03/16/98 ISR Number: 3139143-1 Report Type: Periodic Company Report # 8-98028-023N Age:73 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Condition Aggravated Consumer Prempro PS ORAL 1 TABLET ONCE
Pain Nos
DAILY ORAL
Unspecified
Blood
21-Dec-2001 11:15 AM
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Pressure
Medicine C
Date:
03/16/98 ISR Number: 3139144-3 Report Type: Periodic Company Report # 8-98016-001N Age:50 YR Gender: Female I/FU:
I
Outcome PT Report Source
Product Role Manufacturer Route
Dose Duration
Other Alopecia Consumer Prempro PS ORAL
1 TABLET ONCE
DAILY ORAL
Date:
03/16/98 ISR Number: 3139146-7 Report Type: Periodic Company Report # 8-98028-024N Age:63 YR
Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Menometrorrhagia Consumer
Premphase PS ORAL 1 TABLET ONCE
DAILY ORAL
Moduretic C
Synthroid C
Tenormin C
Date:
03/16/98 ISR Number: 3139148-0 Report Type: Periodic Company Report # 8-98029-001R Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Palpitations Health Prempro PS
ORAL 1 TABLET ONCE
Professional
DAILY ORAL
Company
Representative
Date:
03/16/98 ISR Number: 3139149-2 Report Type: Periodic Company Report # 8-98016-002N Age:53 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Alopecia Health Prempro PS
ORAL 1 TABLET ONCE
Professional
DAILY ORAL
Antihypertensive
Agent C
Date:
03/16/98 ISR Number: 3139151-0 Report Type: Periodic Company Report # 8-98029-003R Age:65 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Menometrorrhagia Health Premphase PS ORAL 1 TABLET ONCE
Neoplasm Nos Professional DAILY ORAL
Lopid C
Cozaar C
Calcium C
Date:
03/16/98 ISR Number: 3139152-2 Report Type: Periodic Company Report # 8-98029-004N Age:76 YR Gender: Female I/FU:
I
Outcome PT
Report Source
Product Role Manufacturer Route
Dose Duration
Other Breast Pain Consumer Prempro PS ORAL
1 TABLET ONCE
DAILY ORAL
Lipitor C
Ziac C
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Date:
03/16/98 ISR Number: 3139153-4 Report Type: Periodic Company Report # 8-98016-003N Age:68 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Breast Pain Consumer Prempro PS ORAL 1 TABLET ONCE
DAILY
ORAL
Fosamax C
Orudis C
Date:
03/16/98 ISR Number: 3139155-8 Report Type: Periodic Company Report # 8-98029-004R Age: Gender:
Female I/FU: I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Alopecia Consumer Prempro PS ORAL 1 TABLET ONCE
DAILY ORAL
Date:
03/16/98 ISR Number: 3139157-1 Report Type: Periodic Company Report # 8-98029-005N Age:53 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose Duration
Other Condition Aggravated Consumer Prempro
PS
ORAL ORAL
Thyroid Disorder
Nos Levothyroid C
Tofranil C
Zoloft C
Hydrodiuril C
Date:
03/16/98 ISR Number: 3139158-3 Report Type: Periodic Company Report # 8-98016-004N Age:64 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Purpura Nos Consumer Prempro PS ORAL 1
TABLET ONCE
DAILY ORAL
Cuprimine C
Date:
03/16/98 ISR Number: 3139159-5 Report Type: Periodic Company Report # 8-98029-005R Age:74 YR Gender: Female I/FU:
I
Outcome PT Report Source Product
Role Manufacturer Route Dose
Duration
Other Hypercalcaemia Consumer Prempro PS ORAL 1 TABLET ONCE
DAILY ORAL
Levoxyn C
Date:
03/16/98 ISR Number: 3139161-3 Report Type: Periodic Company Report # 8-98016-005N Age:62 YR Gender: Female I/FU:
I