Person who experienced the adverse event (patient)
| Event ID | CASE | I F COD | FOLL SEQ | IMAGE | EVENT DT | MFR DT | FDA DT | REPT COD | MFR NUM | MFR SNDR | AGE | AGE COD | GNDR COD | E SUB | WT | WT COD | REPT DT | OCCP COD | DEATH DT | TO MFR | CONFID | REPORTER COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 5483634 | 6638868 | I | 5483634-5 | 20070912 | 20071004 | 20071010 | EXP | 2007331620 | JOHNSON AND JOHNSON GROUP OF CONSUMER COMPANIES | 62 | YR | F | N | 20071009 | CN | UNITED STATES |
Drug(s) used by person
| Event ID | DRUG SEQ | ROLE COD | DRUGNAME | VAL VBM | ROUTE | DOSE VBM | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 5483634 | 1009033239 | PS | BENADRYL CREAM EXTRA STRENGTH (DIPHENHYDRAMINE, ZINC ACETATE) | 2 | TOPICAL | 3 X A DAY, TOPICAL | Y | D | 559D61 | 19981201 | |
| 5483634 | 1009052437 | SS | BENADRYL CREAM EXTRA STRENGTH (DIPHENHYDRAMINE, ZINC ACETATE) | 2 | 459N6L | 20081101 | |||||
| 5483634 | 1009052438 | SS | PREDNISONE TAB | 1 | ORAL | 40MG, ORAL | U | U |
Indications of drugs used
| Event ID | DRUG SEQ | INDI PT |
|---|---|---|
| 5483634 | 1009033239 | DERMATITIS CONTACT |
| 5483634 | 1009052438 | DERMATITIS CONTACT |
Outcome of event
| Event ID | OUTC COD |
|---|---|
| 5483634 | OT |
Reactions reported
| Event ID | PT |
|---|---|
| 5483634 | CONDITION AGGRAVATED |
| 5483634 | DERMATITIS CONTACT |
| 5483634 | DRUG INEFFECTIVE |
| 5483634 | EYE SWELLING |
| 5483634 | INSOMNIA |
| 5483634 | LIP PAIN |
| 5483634 | PAIN |
| 5483634 | PRURITUS |
| 5483634 | RASH ERYTHEMATOUS |
| 5483634 | SKIN BURNING SENSATION |
| 5483634 | STOMATITIS |
| 5483634 | THROAT TIGHTNESS |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | RPSR COD |
|---|---|
| 5483634 | CSM |
Therapies reported
| Event ID | DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|
| 5483634 | 1009033239 | 20070901 |