Received Jul 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
Immunosuppressed patient after Hep A vaccine; This serious case was reported by a nurse via call center representative and described the occurrence of immunocompromised in a male patient who received Hepatitis A vaccine solution for injection for prophylaxis. The patient received Hepatitis A vaccine. The patient experienced immunocompromised (Verbatim: Immunosuppressed patient after Hep A vaccine) (serious criteria GSK medically significant). The outcome of the immunocompromised was unknown. The reporter considered the immunocompromised to be unrelated to Hepatitis A vaccine. The company considered the immunocompromised to be unrelated to Hepatitis A vaccine. Additional Information: GSK Receipt Date: 10-JUL-2026 The reporter called about Havrix vaccine, registered nurse said that a patient was undergoing immunosuppressive therapy and later would be undergoing a bone marrow biopsy procedure. Registered Nurse wanted to know for how long they should wait after the biopsy procedure so the patient could get the vaccine. Registered Nurse said that the patient received Hep A when they were a child but did not specify the age. Brand of Hep A unknown. Registered Nurse stated that they were just reviewing the information provided to them by the oncology provider. When asked if the patient became immunocompromised taking immunosuppressant medication after vaccination with the Hepatitis A vaccine, registered nurse states they did not think so. Registered nurse stated that the immunosuppressant was from something else. It was not from the vaccine. Registered nurse stated that they thought they just wanted to get revaccinated and, if so, what the timeline was for that. registered nurse thought also the concern was that the patient was going to be traveling outside the country. Registered nurse stated that they did not have all the information on this patient. Registered nurse was just trying to get some preliminary information so they could provide to the provider. Healthcare Practitioner said that the patient received Hep A vaccine as a child but did not specify the date of the patient. We report this as a potential adverse event since the patient received the Hep A vaccine, and then, the patient started with immunosuppressive therapy and later would be undergoing a bone marrow biopsy procedure. Also, this was a potential adverse event because they didn't provide the Hep A vaccine brand name We set this as Havrix because the system did not allow to leave it in blank Follow-up contact was attempted, but the healthcare professional was unreachable. The batch number was not provided and a request for this information has been made.; Sender's Comments: A case of Immunodeficiency, on an unknown time after vaccination with unknown dose of Hepatitis A vaccine, in a male patient. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility and alternative etiology (patient is currently undergoing immunosuppressive therapy) based on medical history.