Received Jan 21, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (HAVRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | Z012608 | — |
headache; pain; nausiness; malaise; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 55-year-old female patient who received HAV (Havrix) (batch number Z012608, expiry date 04-MAY-2027) for prophylaxis. On 16-JAN-2026, the patient received Havrix. On 16-JAN-2026, less than a day after receiving Havrix, the patient experienced headache (Verbatim: headache), pain (Verbatim: pain), nausea (Verbatim: nausiness) and malaise (Verbatim: malaise). The outcome of the headache, pain, nausea and malaise were unknown. It was unknown if the reporter considered the headache, pain, nausea and malaise to be related to Havrix and Havrix Pre-Filled Syringe Device. It was unknown if the company considered the headache, pain, nausea and malaise to be related to Havrix and Havrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 16-JAN-2026 The patient had received a Hepatitis A vaccine approximately one hour earlier. The reporter reported that the caller was unsure of the vaccine's brand name and believed it could have been either GSK or Merck. The reporter reported that the caller requested information using the lot number they had available.