Received Nov 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | IM / RL |
| MMR | MEASLES + MUMPS + RUBELLA (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | SC / RA |
| PNC13 | PNEUMO (PREVNAR13) | PFIZER\WYETH | 1 | UNK | IM / LL |
| VARCEL | VARICELLA (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | SC / LA |
sapovirus; This 17-month-old male subject was enrolled in a blinded study titled A Phase 3a, observer-blind, randomized, controlled study to demonstrate lot-to-lot consistency and evaluate the immunogenicity and safety of an investigational varicella vaccine compared with Varivax, administered as a first dose to healthy children 12 to 15 months of age. The subject received the 1st dose of Varicella VNS Vs Varivax (subcutaneous, left deltoid) on 25-JUN-2025 11:37, for prophylaxis. The subject received the 1st dose of MMR vaccine (subcutaneous, right deltoid) .5 ml on 25-JUN-2025 11:37, for prophylaxis. The subject received the 1st dose of Hepatitis A vaccine (intramuscular, right thigh) .5 ml on 25-JUN-2025 11:37, for prophylaxis. The subject received the 1st dose of Prevnar 13 (intramuscular, left thigh) .5 ml on 25-JUN-2025 11:37, for prophylaxis. On 16-NOV-2025, 144 days after receiving Varicella VNS Vs Varivax, MMR vaccine, Hepatitis A vaccine and Prevnar 13, the subject developed severe - grade 3 sapovirus infection (Verbatim: sapovirus). Serious criteria included hospitalization. The outcome of sapovirus infection was resolving. The investigator considered that there was no reasonable possibility that the sapovirus infection may have been caused by Varicella VNS Vs Varivax, MMR vaccine, Hepatitis A vaccine and Prevnar 13. The company considered that there was no reasonable possibility that the sapovirus infection may have been caused by Varicella VNS Vs Varivax, MMR vaccine, Hepatitis A vaccine and Prevnar 13. GSK receipt date: 19-NOV-2025 gastroenteritis due to sapovirus. SAE (serious adverse event) was not related to Study Treatment.; Sender's Comments: A case of Sapovirus infection, 144 days after receiving 1st dose of Varicella VNS Vs Varivax, 1st dose of MMR vaccine, 1st dose of Hepatitis A vaccine, 1st dose of Prevnar 13, in a 17-month-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility