Received Mar 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | Y013583 | OT / LL |
no additional AE; received improperly stored PROQUAD since it "was stored in the refrigerator for months" instead of the freezer; This spontaneous report was received from a Nurse and refers to a(n) 4-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus (VAXELIS) Havrix (Hepatitis a vaccine inact), Fluarix quadrivalent (Influenza vaccine inact split 4v). On 02-Dec-2024, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Injection (lot #Y013583, expiration date: 03-Feb-2026), dose number 2, administered by subcutaneous route in Left Thigh together with sterile diluent (MERCK STERILE DILUENT) (expiration date, and lot # were not reported) as prophylaxis. The suspect vaccine "was stored in the refrigerator for months" instead of the freezer (incorrect product storage). There was no additional AE (no adverse event). Temperature excursion was reported as "Total time in the range 15°F to 46°F (-9°C to 8°C): 1488" (time units not reported).; Sender's Comments: Priority : 5 , Is case serious : No , Index user : @merck.com , Index date : 2025-02-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 10/xx/2020 , Central date : 2025-02-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Vaxelis; Havrix; Fluarix quadrivalent; sterile diluent