Received Oct 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 1 | 947931 | — |
Arthralgia; Muscle Cramping; Tingling in Fingers and Toes; Myalgia; Initial report received on 17-Sep-2025. A physician reported that a 35-year-old male received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient experienced paresthesia, myalgia, arthralgia, and muscle cramping. Medical history included an allergy to sulfa drugs. No concomitant medications were reported. On 08-Jul-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number947931, expiration date 15-May-2027and NDC number 43528-0003-05; site not provided)] intramuscularly. On an unknown date, after receiving HEPLISAV-B, the patient experienced paresthesia, myalgia, arthralgia, and muscle cramping. Paresthesia manifested as tingling in fingers and toes with no associated muscle weakness. The patient has not received the second dose. The outcome was not reported. No additional information was reported. Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Drug allergy (Sulfa)