Received Oct 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 1 | 946064 | IM |
Had a Dose of Recombivax then a Dose of HEPLISAV-B; Initial report received on 15-Sep-2025. A pharmacist reported that a 40-year-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after receiving RECOMBIVAX previously. Medical history included a sulfa allergy. No concomitant medications were reported. On 19-Jun-2025, the patient received dose 1 of a hepatitis B vaccine [RECOMBIVAX HB (lot number not available)]. On 19-Jul-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number 946064, expiration date 31-Aug-2027, and NDC number 43528-003-05; site not available)] intramuscularly. No other side effects were reported. No other information was available. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Drug allergy (Unknown reaction)
Recombivax