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Report #2827190

Received Mar 13, 2025

A note on interpretation. VAERS reports are unverified and may be incomplete or coincidental. A report does not establish that a vaccine caused an event, and counts should not be used to calculate incidence or infer causation. Full disclaimer

Overview

Sex
Male
Age
12 yrs
State
ND
Recovered
Unknown
Vaccinated
Jan 6, 2025
Onset
Jan 6, 2025
Days to onset
0
Hospital days
—

Vaccines (6)

TypeNameManufacturerDoseLotRoute / Site
FLU4INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT)GLAXOSMITHKLINE BIOLOGICALS172RF2IM / RA
HEPHEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS195BJ9IM / LA
HEPAHEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS1T5727IM / RA
MMRVMEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.1Y013579SC / RA
MMRVMEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.UNKY013579OT / RA
MMRVMEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.UNK—OT

Symptoms (2)

Product storage errorNo adverse event

Symptom narrative

No adverse event; HCP reports multiple patients may have received improperly stored PROQUAD since it "was stored in the refrigerator for months" instead of freezer.; This spontaneous report was received from a nurse and refers to a 12-year-old male patient. The patient's medical history, concurrent conditions, drug reactions or allergies were not reported. Concomitant medications included Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Hepatitis b vaccine rHBsAg (yeast) (ENGERIX B), Influenza vaccine inact split 4v (FLUARIX QUADRIVALENT), Polio vaccine inact 3v (Vero) (IPOL), Diphtheria vaccine toxoid;Pertussis vaccine acellular 3-component;Tetanus vaccine toxoid (BOOSTRIX), Meningococcal vaccine A/C/Y/W conj (CRM197) (MENVEO), Hepatitis a vaccine inact (HAVRIX) . On 06-JAN-2025, the patient was vaccinated with the first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection (valid lot number Y013579, expiration date: 03-FEB-2026), administered by subcutaneous route in right arm, with sterile diluent (BAXTER STERILE DILUENT) for prophylaxis (dose and vaccination scheme were not provided), after a temperature excursion since it "was stored in the refrigerator for months" instead of freezer, with a total time in the range 15 degrees Fahrenheit (F) to 46 degrees F of 1296 (units not provided) since 13-NOV-2024 (reported as 2025, conflicting information) (product storage error). No additional adverse event (AE).

Other medications

Engerix B; Fluarix quadrivalent; IPOL; Boostrix; Menveo; Havrix; Gardasil 9