Received Jul 1, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (RECOMBIVAX HB) | MERCK & CO. INC. | UNK | Z015658 | — |
No additional AE reported; improperly stored vaccines were administered; This Spontaneous report was received from Other health professional and referred to a/an ( Race Unknown ) ( Ethnicity Unknown) patient of unknown age and gender. The patient's medical history was not reported. The patient's past medications were not reported. The patient's concomitant medications were not reported. On 08-Jun-2026, the patient started therapy with Hepatitis B Vaccine (Recombinant), 10 mcg/mL Suspension for injection 64457236:4094 (Batch/Lot Number: Z015658) (Expiration date: 14-Jul-2028). The patient started therapy with Hepatitis B Vaccine (Recombinant), 10 mcg/mL Suspension for injection 64457236:4094 for the treatment of prophylaxis, On 08-Jun-2026, the patient experienced improperly stored vaccines were administered (Product storage issue). On an unknown date, the patient experienced No additional AE reported (No adverse event). The Outcome of Product storage issue was not provided. The Outcome of No adverse event was not provided. The action taken with Hepatitis B Vaccine (Recombinant), 10 mcg/mL Suspension for injection 64457236:4094 regarding Product storage issue was Not applicable with Not Applicable dechallenge and rechallenge results. Case Assessments: Hepatitis B Vaccine (Recombinant), 10 mcg/mL Suspension for injection 64457236:4094 regarding No adverse event with Not Applicable dechallenge and rechallenge results. The Other health professional considered the event Product storage issue (,) to be not assessed to Hepatitis B Vaccine (Recombinant), 10 mcg/mL Suspension for injection 64457236:4094 and the event No adverse event (,) to be not assessed to Hepatitis B Vaccine (Recombinant), 10 mcg/mL Suspension for injection 64457236:4094 The Other health professional considered the event No adverse event to be non-serious and the event Product storage issue to be non-serious