Received Mar 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 1 | 3044210 | IM / RL |
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | 2 | W1C831M | SC / RA |
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | 2 | Y013583 | SC / LA |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | Y013583 | OT / LA |
No adverse event; Product storage error; Information has been received from Business Partner/CRO on . This spontaneous report was received from a/an Nurse and refers to a(n) 6-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included Ipol (Polio vaccine inact 3v (Vero)), Moderna COVID-19 vaccine (Elasomeran) . On 09-Jan-2025, the patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y013583, expiration date: 03-Feb-2026), dose number 2, administered by Subcutaneous route in Left Arm. On 09-Jan-2022, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), administered by Subcutaneous route (indication, expiration date, and lot # were not reported). The patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), for the treatment of prophylaxis. On 09-Jan-2025, the patient experienced Product storage error. On an unknown date, the patient experienced No adverse event. At the reporting time, the outcome of Product storage error and No adverse event was unknown. The action taken with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live and sterile diluent was reported as not applicable. The causal relationship between the event of No adverse event and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live was unknown/not reported/not provided. The causal relationship between the event of Product storage error and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live was unknown/not reported/not provided. The causal relationship between the event of Product storage error and sterile diluent was unknown/not reported/not provided. The causal relationship between the event of No adverse event and sterile diluent was unknown/not reported/not provided.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-02-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 11/14/2018 , Central date : 2025-02-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
IPOL; COVID vaccine; Sterile diluent