Received Jun 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | UNK | Z016964 | — |
No symptoms were reported. No additional AE; PROQUAD was administered to the patient after it was improperly stored; This Spontaneous report was received from Administrator / Supervisor and referred to a/an ( Race Unknown ) ( Ethnicity Unknown) patient of unknown age and gender. The patient's medical history was not reported. The patient's past medications were not reported. The patient's concomitant medications were not reported. On 15-Jun-2026, the patient started therapy with sterile diluent Solution for injection 64466651:4175 (total) (Batch/Lot Number: 2171666) (Expiration date: 20-Dec-2027) dose form was Solution for injection. On 15-Jun-2026, the patient started therapy with MMR and Varicella (Oka-Merck) Virus Vaccine Live (0.50 mL) (total) (Batch/Lot Number: Z016964) (Expiration date: 04-May-2027) dose form was Powder and solvent for solution for injection/infusion. The patient started therapy with MMR and Varicella (Oka-Merck) Virus Vaccine Live for the treatment of Prophylaxis, The patient started therapy with sterile diluent Solution for injection 64466651:4175 for the treatment of Prophylaxis, On 15-Jun-2026, the patient experienced PROQUAD was administered to the patient after it was improperly stored (Product storage issue). On an unknown date, the patient experienced No symptoms were reported. No additional AE (No adverse event). Site Narrative: Temperature 14°F up to 46°F (36.3 F) Time frame 14°F up to 46°Ffor 1 hour 0 minutes 0 seconds; 6°F up to 14°F for 0 hours 30 minutes 0 seconds Previous temperature excursion? YES; 14°F up to 46°F (37.6 F) for 2 hour 15 minutes; 6°F up to 14°F for 0 hours 18 minutes 0 seconds. The Outcome of Product storage issue was not provided. The Outcome of No adverse event was not provided. The action taken with sterile diluent Solution for injection 64466651:4175 regarding Product storage issue was Not applicable with Not Applicable dechallenge and rechallenge results. The action taken with MMR and Varicella (Oka-Merck) Virus Vaccine Live regarding Product storage issue was Not applicable with Not Applicable dechallenge and rechallenge results. Case Assessments: MMR and Varicella (Oka-Merck) Virus Vaccine Live regarding No adverse event with Not Applicable dechallenge and rechallenge results. Case Assessments: sterile diluent Solution for injection 64466651:4175 regarding No adverse event with Not Applicable dechallenge and rechallenge results. The Administrator / Supervisor considered the event No adverse event (,) to be not assessed to MMR and Varicella (Oka-Merck) Virus Vaccine Live, the event Product storage issue (,) to be not assessed to sterile diluent Solution for injection 64466651:4175, the event No adverse event (,) to be not assessed to sterile diluent Solution for injection 64466651:4175, and the event Product storage issue (,) to be not assessed to MMR and Varicella (Oka-Merck) Virus Vaccine Live The Administrator / Supervisor considered the event Product storage issue to be non-serious and the event No adverse event to be non-serious Linked Case(s): Same Reporter: US-009507513-2440895 and Same Reporter: US-009507513-2440832
MERCK STERILE DILUENT