Received Mar 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | Y013579 | OT / LA |
No additional adverse event; HCP reports multiple patients may have received improperly stored PROQUAD since it "was stored in the refrigerator for months" instead of the freeze; This spontaneous report has been received from a nurse, regarding a 7-year-old female patient. The patient's concomitant therapies included polio vaccine inact 3v (vero) (IPOL) and diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) tetanus vaccine toxoid) (BOOSTRIX). The patient's pertinent medical history, concurrent conditions, and previous drug reactions or allergies were not reported. On 08-JAN-2025, the patient was vaccinated with an improperly stored second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live lyophilisate and solvent for solution for injection (rHA [recombinant human albumin]) (PROQUAD) administered subcutaneously on the left arm as prophylaxis (Lot No. Y013579 has been verified to be a valid lot number for [measles, mumps, rubella and varicella (oka-merck) virus vaccine live lyophilisate and solvent for solution for injection], expiration date was not reported but upon internal validation established as 03-FEB-2026) (strength and vaccination scheme frequency were not reported) (product storage error) after a temperature excursion with a range of 15 degree Fahrenheit (F) to 46 degree Fahrenheit (F) (-9 degree Celsius to 8 degree Celsius during a time frame of 1344 (time units not provided). No previous temperature excursion was reported. No additional information or adverse events were provided (no adverse event).; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-02-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 04/12/2017 , Central date : 2025-02-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Inactivated Polio Virus (IPOL); Tdap (BOOSTRIX); Sterile Diluent