Received Sep 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 1 | — | IM / LA |
First Dose of HEPLISAV-B In May of 2025, Told to Wait 6 Months for Second; Injection Site Pain; Initial report received on 14-Aug-2025. A consumer in the US (TX) reported that her husband, an 80-year-old male (race and ethnicity not reported), received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and did not receive the second dose yet and experienced injection site pain. Medical history included allergies to amiodarone, propranolol, flecainide, MULTAQ (dronedarone), metoprolol, and sotalol. All medications caused throat swelling. No concomitant medications were reported. In May-2025, the patient received dose 1 of a hepatitis B vaccine HEPLISAV-B (lot #; expiration date and NDC #, route not available) in the left arm. In May-2025, after receiving HEPLISAV-B, the patient experienced injection site pain for two days. At the time of reporting, the patient had not received the second dose of HEPLISAV-B yet. The pharmacy instructed the patient to wait six months before receiving the second dose. No other information was available. Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Drug allergy (Flecainide; Causes throat swelling); Drug hypersensitivity (Sotolol; Causes throat swelling); Drug hypersensitivity (Propranolol; Causes throat swelling); Drug hypersensitivity (Multaq; Causes throat swelling); Drug hypersensitivity (Metoprolol; Causes throat swelling); Drug hypersensitivity (Amiodarone; Causes throat swelling)