Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115393066 | 11539306 | 6 | F | 20160922 | 20150923 | 20160926 | PER | US-PFIZER INC-2015317485 | PFIZER | 11.00 | YR | M | Y | 0.00000 | 20160926 | MD | US | US |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115393066 | 11539306 | 1 | PS | GENOTROPIN | SOMATROPIN | 1 | Subcutaneous | 1.2 MG, DAILY | N | 20280 | 1.2 | MG | POWDER FOR SOLUTION FOR INJECTION | ||||||
| 115393066 | 11539306 | 2 | SS | GENOTROPIN | SOMATROPIN | 1 | 1.2 MG, DAILY, (EVERY NIGHT) | N | M47802 | 20280 | 1.2 | MG | POWDER FOR SOLUTION FOR INJECTION | ||||||
| 115393066 | 11539306 | 3 | SS | GENOTROPIN | SOMATROPIN | 1 | 0.8 MG, (RECEIVED A PARTIAL DOSE OF 0.8 MG OF THE 1.3 MG) | N | 20280 | .8 | MG | POWDER FOR SOLUTION FOR INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115393066 | 11539306 | 1 | Growth hormone deficiency |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115393066 | 11539306 | Mood altered | |
| 115393066 | 11539306 | Poor quality drug administered | |
| 115393066 | 11539306 | Product quality issue | |
| 115393066 | 11539306 | Sluggishness |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 115393066 | 11539306 | 1 | 201506 | 201506 | 0 | |
| 115393066 | 11539306 | 2 | 201506 | 0 | ||
| 115393066 | 11539306 | 3 | 201506 | 0 |