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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125209201 | 12520920 | 1 | I | 20160527 | 20160701 | 20160701 | EXP | IN-JNJFOC-20160626285 | JANSSEN | SHAH KH, MEHTA NH. TRANSIENT LOSS OF VOICE DURING LABOUR ANALGESIA. INDIAN JOURNAL OF ANAESTHESIA. 2016;60(5):366-367. | 30.00 | YR | A | F | Y | 0.00000 | 20160701 | MD | IN | IN |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125209201 | 12520920 | 1 | PS | FENTANYL. | FENTANYL | 1 | Intrathecal | INJECTED VIA 26 G QUINCKE NEEDLE AT L3 ??AND L4 SPACE. | N | 0 | 10 | UG | INJECTION | ||||||
| 125209201 | 12520920 | 2 | SS | BUPIVACAINE. | BUPIVACAINE | 1 | Intrathecal | 1 CC OF 0.25% PRESERVATIVE FREE BUPIVACAINE DOUBLE DILUTED WITH STERILE NORMAL SALINE. | 0 | UNSPECIFIED | |||||||||
| 125209201 | 12520920 | 3 | SS | BUPIVACAINE. | BUPIVACAINE | 1 | Intrathecal | FOR EPISIOTOMY SUTURING | 0 | UNSPECIFIED | |||||||||
| 125209201 | 12520920 | 4 | C | NORMAL SALINE | SODIUM CHLORIDE | 1 | Intrathecal | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125209201 | 12520920 | 1 | Analgesic therapy |
| 125209201 | 12520920 | 2 | Analgesic therapy |
| 125209201 | 12520920 | 3 | Analgesic therapy |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125209201 | 12520920 | Aphonia | |
| 125209201 | 12520920 | Exposure during pregnancy | |
| 125209201 | 12520920 | Incorrect route of drug administration | |
| 125209201 | 12520920 | Off label use |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |