Received Aug 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (HAVRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | UNK | Z007853 | — |
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Z003767 | — |
No additional AE; FBE calling to report AE on behalf of HCP for PROQUAD and VARIVAX. HCP reported both vaccines were administered on 07/25/2025 in addition to the HAVRIX. Precautionary full AE as caller unable to confirm if patient was symptomatic or not. Patient also; This spontaneous report was received from a physician via Company employee and refers to a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 25-Jul-2025, the patient was vaccinated with both Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot #Z007853, expiration date: 19-Oct-2026), and Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE) (lot #Z003767, expiration date: 30-Jan-2027) as prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not provided). The patient also received HAVRIX (indication, expiration date, and lot # were not reported) on the same day (Vaccine overdose). No other information available at this moment. No additional adverse event (AE) (No adverse event).
Sterile Diluent