Received May 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | UNK | Y000225 | — |
No additional AE/PQC.; MMR II turned clear after reconstitution; MMR II turned clear after reconstitutio. HCP is concerned she may have administered a clear colored MMR II to the patient along side the "normal looking yellow/gold colored vaccine that was assumed to be MMR II based on the color.; This spontaneous report was received from a health care professional (HCP) and refers to a 15-year-old patient of unknown gender. The patient's medical history, concurrent conditions, previous drugs reactions or allergies were not reported, concomitant therapies included Varicella Virus Vaccine Live (Oka-Merck) lyophilisate and solvent for solution for injection (VARIVAX) with its reconstituent sterile diluent (MERCK STERILE DILUENT). On 16-Apr-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (valid lot #Y000225, expiration date: 03-Jan-2026)at a dose of 0.5 mL, reconstituted with sterile diluent (BAXTER STERILE DILUENT) solution for injection pre-filled syringe (valid lot #Y020691, expiration date: 10-Nov-2027) (route of administration not provided) for prophylaxis; HCP stated her coworker reconstituted the vaccines in preparation for her to administer, the prepared reconstituted vaccines were given to her to administer to the patient, she administered a clear colored vaccine to the patient that HCP assumed to be Varicella Virus Vaccine Live (Oka-Merck) lyophilisate and solvent for solution for injection (VARIVAX) based on clear color appearance. HCP went to administer the second vaccine but noticed it was also a clear liquid. HCP knows Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), to be a yellow/gold color so she decided to not administer the second prepared clear colored syringe and obtained another prepared Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), syringe with a yellow/gold color liquid. It was unknown what was in either syringe as neither syringe was labeled. HCP was concerned the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) turned clear after reconstitution and that was why she had 2 clear colored liquid vaccines. HCP was concerned she might have administered a clear colored Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) to the patient alongside the "normal looking yellow/gold colored" vaccine that was assumed to be Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) based on the color (Poor quality product administered, Product colour issue). HCP reported it was unknown if the first vaccine she administered to patient could have been Varicella Virus Vaccine Live (Oka-Merck) lyophilisate and solvent for solution for injection (VARIVAX) or the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) because they were both clear and unlabeled. No symptoms reported; no additional adverse event (AE) (No adverse event). Follow-up information was received on 25-APR-2025. On 25-APR-2025, the sample was delivered to facility. The sample consisted of a vial matching the reported lot number. HCP reported the sample she returned was not lyophilized and reported it was the defective reconstituted vaccine. HCP reported she took the vaccine from the syringe and was able to put it back into the vials to send. HCP also reported the sterile diluent that she sent in was additional diluent from the lot used to reconstitute.
VARIVAX; varivax; Sterile diluent