Received Aug 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (RECOMBIVAX HB) | MERCK & CO. INC. | UNK | X027728 | — |
No additional AE; Customer called to report TE.; This spontaneous report was received from a pharmacist, concerning to a neonate patient of unknown gender. The patient's medical history, patient's concurrent conditions and concomitant therapies were not reported. On an unknown date, the vaccine Hepatitis B Vaccine (Recombinant) experienced a temperature (TE) excursion at 11.5 C for 2 hours. On 18-Jun-2025, the patient was vaccinated with the vaccine involved in the TE, Hepatitis B Vaccine (Recombinant) (lot #X027728 has been verified to be valid as a pre-filled syringe, expiration date reported and confirmed as 16-Oct-2026) (dose and route were not provided), as prophylaxis (Product storage error). No additional adverse event reported (No adverse event).