Symptomtext
lack of drug effect; diarrhea; fever; Inappropriate age at vaccine administration; wrong vaccine administered; This spontaneous report was received from a consumer, concerning a 7-month-old male patient. No information was provided regarding the patient's relevant medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies. On 23-MAY-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), at a dose of 0.5 milliliter (ml), once in the left thigh by subcutaneous route (lot number, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 29-MAR-2023) (product administered to patient of inappropriate age) and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), 1 dosage form orally (lot number 1863317 is an invalid lot number for Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ). Lot number 1863317 does not match any Company product as confirmed by Lot Verification team. Furthermore, it was reported the patient was supposed to be vaccinated with diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VAXELIS), but he received diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (QUADRACEL), at a dose of 0.5 ml, once in the left vastus lateralis by intramuscular route (lot number: C5970AA, expiration date not reported) instead (wrong product administered). All the vaccines were administered as prophylaxis. On an unknown date, the patient experienced mild fever (pyrexia), diarrhea and lack of drug effect. At the time of the report, the outcome of the events was unknown. The causality between the events and diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VAXELIS) was not related. The causal relationship between events and the remaining suspect vaccines was related, further described as "expected side effects of given vaccines". This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2206USA006736: