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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126453091 | 12645309 | 1 | I | 20121127 | 20130101 | 20160811 | 20160811 | EXP | GB-MHRA-ADR 21963844 | GB-PFIZER INC-1549225 | PFIZER | 10.00 | MON | F | Y | 0.00000 | 20160811 | MD | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126453091 | 12645309 | 1 | PS | ERYTHROMYCIN. | ERYTHROMYCIN | 1 | 1 DF, UNK | U | UNK | 50609 | 1 | DF | POWDER FOR INJECTION | ||||||
| 126453091 | 12645309 | 2 | I | PHENYTOIN. | PHENYTOIN | 1 | Intravenous (not otherwise specified) | UNK | N | UNK | 89521 | SOLUTION FOR INJECTION | |||||||
| 126453091 | 12645309 | 3 | I | DIAZEPAM. | DIAZEPAM | 1 | Rectal | UNK | N | 0 | |||||||||
| 126453091 | 12645309 | 4 | I | MIDAZOLAM | MIDAZOLAMMIDAZOLAM HYDROCHLORIDE | 1 | Other | 2.5 MG, FREQ: AS NECESSARY | U | 0 | 2.5 | MG | |||||||
| 126453091 | 12645309 | 5 | C | LEVETIRACETAM. | LEVETIRACETAM | 1 | UNK | 0 | |||||||||||
| 126453091 | 12645309 | 6 | C | VALPROATE | VALPROIC ACID | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126453091 | 12645309 | 1 | Nasopharyngitis |
| 126453091 | 12645309 | 2 | Seizure |
| 126453091 | 12645309 | 3 | Seizure |
| 126453091 | 12645309 | 4 | Seizure |
| 126453091 | 12645309 | 5 | Epilepsy |
| 126453091 | 12645309 | 6 | Epilepsy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126453091 | 12645309 | HO |
| 126453091 | 12645309 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126453091 | 12645309 | Cardiac arrest neonatal | |
| 126453091 | 12645309 | Drug ineffective | |
| 126453091 | 12645309 | Drug interaction | |
| 126453091 | 12645309 | Hypoventilation | |
| 126453091 | 12645309 | Respiratory acidosis | |
| 126453091 | 12645309 | Tachycardia |
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 |
|---|---|---|---|---|---|---|
| 126453091 | 12645309 | 1 | 20121126 | 0 | ||
| 126453091 | 12645309 | 2 | 20121127 | 20121127 | 0 | |
| 126453091 | 12645309 | 3 | 20121127 | 20121127 | 0 |