Received Mar 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (HAVRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | t5727 | OT |
| HIBV | HIB (HIBERIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 437EK | OT |
| MMR | MEASLES + MUMPS + RUBELLA (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | Y008290 | OT / LA |
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y015108 | OT / RA |
no adverse event; Caller reported VARIVAX administered after temperature excursion. No other information provided. ? Names of vaccines involved (including lot/exp) VARIVAX Y015108 9/6/2026 ? Temperature (-2.1C) ? Time frame 6; This spontaneous report was received from a Other health professional and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 06-Feb-2025, the patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Y015108, expiration date: 06-Sep-2026) for prophylaxis. On 06-Feb-2025, the patient started therapy with sterile diluent (BAXTER STERILE DILUENT), for prophylaxis (lot # and expiration date were not reported). This vaccine underwent temperature excursion in -2.1 degree Celsius for 6 hours 45 minutes (Product storage error). Follow up information has been received on 06-FEB-2025. The patient experienced no adverse event. The route of administration for Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) was subcutaneously in the right arm. On the same date, the subject was vaccinated with improperly stored doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live lyophilisate (MMR-II) injection, subcutaneously in the left arm, lot number Y008290 which has been verified to be valid, expiration date reported and validated as 24-APR-2026 (doe, scheme, strength not provided). The patient was vaccinated with HIB vaccine conj (tet tox) (HIBERIX), intramuscular , left thigh, lot number 437EK, expiration date reported as 13-JUL-2026. Consequently, the patient was vaccinated with Hepatitis A vaccine (HARVIX) intramuscularly in the right thigh, lot number T5727, expiration date 05-MAY-2026 (doses, formulations, strengths not provided).
Sterile diluent