Received May 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | UNK | Y013573 | — |
no symptoms reported; patient who was inadvertently administered PROQUAD at younger than indicated age on 04/25/2025; This spontaneous report was received from a registered nurse (R. N.) concerning a 6-month-old (reported as "6-months and 8-days old") patient of unspecified gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20), and Diphtheria vaccine toxoid (+) Hepatitis b vaccine rHBsAg (yeast) (+) Pertussis vaccine acellular 3-component (+) Polio vaccine inact 3v (Vero) (+) Tetanus vaccine toxoid (Pediarix) were administered concomitantly with the suspect vaccine. On 25-Apr-2025, the patient was inadvertently administered Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) at younger than indicated age (batch/lot number Y013573 has been verified to be a valid batch/lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, expiration date reported and upon internal validation established as 03-Feb-2026) 0.5 mL (0.5mL/dose) administered as prophylaxis (dosage regimen, anatomical location and route of administration were not reported) (product administered to patient of inappropriate age), which was diluted with sterile diluent (expiration date and lot # were not reported.) There were no symptoms or additional adverse events (AE) details reported. Lot # is being requested and will be submitted if received.
ROTATEQ; PEDVAXHIB; PREVNAR20; PEDIARIX; Sterile diluent