Received Mar 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
| MMR | MEASLES + MUMPS + RUBELLA (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | X011441 | OT / RL |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | X025482 | OT / RL |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | 1 | — | — |
No additional AE reported; products that experienced temperature excursion were administered to patient; This spontaneous report was received from a registered nurse and refers to a 12-month-old male patient. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 08-JAN-2025 (conflicting information: also reported as 08-JAN-2024), the patient was vaccinated with improperly stored doses of the following vaccines: first dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot #, expiration date, exact dose route and site of administration was not reported) reconstituted with sterile diluent (lot # and expiration date were not reported); first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine (M-M-R II) lot # X011441 was confirmed to be valid, expiration date 19-APR-2025, subcutaneously at right thigh (exact dose was not reported) reconstituted with sterile diluent (lot # and expiration date were not reported); first dose of Hepatitis A Vaccine, Inactivated (VAQTA) lot # X025482 was confirmed to be valid, expiration date 12-APR-2025, intramuscularly at right thigh (exact dose was not reported) fourth dose of Pneumococcal vaccine conj 20v lot # reported as HN2630, expiration date reported as 30-AUG-2025, intramuscularly at right thigh (exact dose was not reported) first doe of Haemophilus influenzae type b vaccine lot # reported as M94PZ, expiration date reported as 14-JUN-2026, intramuscularly at left thigh (exact dose was not reported) all vaccines administered for prophylaxis. The temperature excursion was a result of a reading from a digital data logger, however no details were provided. No additional adverse event was reported. Lot # is being requested and will be submitted if received.