Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC15, VARCEL, HEPA, MMR, PNC15, VARCEL
Symptoms: Death, Diarrhoea, Hypophagia, Malaise, Polymerase chain reaction negative
Clinical narrative: DIARRHOEA; HYPOPHAGIA; MALAISE; RESPIRATORY PATHOGEN PANEL; STREPTOCOCCUS TEST NEGATIVE; UNRESPONSIVE TO STIMULI; VOMITING; Information has been received from Health Authority Food and Drug Administration (agency # 2731576) on 07-MAR-2024, regarding a 1-year-old male patient.   The patient's medical history included hirschsprung's disease, and ostomy takedown. The patient's concurrent conditions included otitis media acute. Concomitant therapies included cholestyramine.  On 05-JAN-2024, the patient was vaccinated with the fourth dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, (lot #X020953, expiration date: 18-OCT-2025, valid lot number per internal review), administered intramuscularly, on the left thigth for prophylaxis (strength was not provided); with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, (lot #X017485, expiration date: 25-JUN-2025, valid lot number per internal review), administered subcutaneously in the right arm for prophylaxis (strength was not provided); with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant Human albumin (M-M-R II) subcutaneous injection, (lot #W031980, expiration date: 06-OCT-2024, valid lot number per internal review), administered subcutaneously for prophylaxis on the left arm (strength was not provided); and with the first dose of hepatitis a vaccine inact (HAVRIX), administered intramuscularly in the left thigh for prophylaxis lot number G79C4 (strength, formulation, and expiry date were not provided).  On 06-JAN-2024, the patient experienced hypophagia, diarrhoea, malaise, respiratory pathogen panel, unresponsive to stimuli, streptococcus test negative, vomiting. On 08-JAN-2024, per local emergency department (ED) report, the patient presented to the ED with diarrhea, vomiting, malaise, and decreased oral (PO) intake. Respiratory panel and streptococcus (reported as strep) polymerase chain reaction (PCR) were completed and were negative. On 10-JAN-2024, the patient presented to the local ED unresponsive and died on the same date (unspecified cause of death). It was unknown if an autopsy was performed.   The causal relationship between the events and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE), varicella virus vaccine live (oka/merck) (VARIVAX), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and hepatitis a vaccine inact (HAVRIX) was not provided.  An investigation into the manufacture of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Lot(s) W031980 and varicella virus vaccine live (oka/merck) (VARIVAX) Lot(s) X017485 was completed and confirmed that all in-process quality checks were satisfactory. The results indicated that the lot was manufactured in accordance with manufacturing site standard operating procedures. The lot was confirmed to have met the requirements for market release. Following medical review of the AE report and the Quality investigation, there were no identified concerns related to quality within the results of the investigation. ; Reported Cause(s) of Death: Death