Received Jul 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 1 | 945664 | IM / LA |
Got Their 1st Dose, Trying to Get Their 2nd Dose Over the One Month Mark; Initial report received on 21-Jul-2025. A pharmacist reported that a 60-year-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and was trying to get the second dose over one month after the first. No medical history or concomitant medications were reported. On 22-May-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number 945664, expiration date 31-Jan-2027 and NDC number 43528-003-05)] intramuscularly in the left deltoid. On 21-Jul-2025, 61 days after receiving the first dose of HEPLISAV-B, the patient presented to the same pharmacy location as the first dose and attempted to get the second dose. The reporter contacted medical information to ask if the patient needed to restart the series. The second dose was not administered. No adverse reactions were reported. No additional information was reported. Company Comment The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.