Received Jun 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 1 | 945662 | IM / LA |
Pain at the Site; Low Grade Fever; Nausea; Headache; 15 year old Patient Was Given Heplisav-B; Initial report received on 07-May-2025. Additional information received on 05-Jun-2025 included confirmation that HEPLISAV-B was given in error, information on the second dose of a hepatitis B vaccine received, and the patient's date of birth. A physician reported that a 15-year-old male received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and reported pain at the site, a low-grade fever, nausea, and a headache the day following the injection. No medical history or concomitant medications were reported. On 09-Apr-2025, the patient received a dose of a hepatitis B vaccine HEPLISAV-B (lot number 945662, expiration date 31-Jan-2027, and NDC number 4352800301) intramuscularly in the left upper deltoid. This dose was ordered and given to the patient unintentionally. The patient was 15 years old when he received the HEPLISAV-B dose. On 10-Apr-2025, the day after having been vaccinated with HEPLISAV-B, the patient reported pain at the injection site, a low-grade fever, nausea, and a headache. On 07-May-2025, 29 days after receiving HEPLISAV-B, the patient received the second dose of a hepatitis B vaccine, ENGERIX-B (lot number and expiration date not provided). The patient received a pediatric dose to complete his hepatitis B series. 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.