Received Jul 22, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | 501316 | IM / RL |
| MMR | MEASLES + MUMPS + RUBELLA (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | 605441 | SC / RA |
| PNC13 | PNEUMO (PREVNAR13) | PFIZER\WYETH | UNK | 704226 | IM / LL |
| VARCEL | VARICELLA (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | 325803 | SC / LA |
adenovirus; This 12-month-old male subject was enrolled in a blinded study titled. The subject received the 1st dose of Varicella VNS Vs Varivax (subcutaneous, left deltoid) (batch number 325803) on 28-MAY-2026 11:16, for Prophylaxis. The subject received the 1st dose of MMR vaccine (subcutaneous, right deltoid) (batch number 605441) on 28-MAY-2026 11:16, for Prophylaxis. The subject received the 1st dose of Hepatitis A vaccine (intramuscular, right thigh) (batch number 501316) on 28-MAY-2026 11:16, for Prophylaxis. The subject received Prevnar 13 (batch number 704226) on 28-MAY-2026 11:16, for Prophylaxis. On 02-JUL-2026, 35 days after receiving Varicella VNS Vs Varivax, MMR vaccine, Hepatitis A vaccine and Prevnar 13, the subject developed severe - grade 3 adenovirus infection (Verbatim: adenovirus). Serious criteria included hospitalization. The outcome of adenovirus infection was resolved on 14-JUL-2026. The investigator considered that there was no reasonable possibility that the adenovirus infection may have been caused by Varicella VNS Vs Varivax, MMR vaccine, Hepatitis A vaccine and Prevnar 13. Other possible cause(s) of the adenovirus infection included Hepatitis A vaccine PRE-FILLED SYRINGE DEVICE and MMR vaccine PRE-FILLED SYRINGE DEVICE. The company considered that there was no reasonable possibility that the adenovirus infection may have been caused by Varicella VNS Vs Varivax, MMR vaccine, Hepatitis A vaccine and Prevnar 13. Additional Information: GSK Receipt Date: 15-JUL-2026 Parent reports several episodes of nonbloody nonbilious emesis, he has been unable to tolerate P.O (oral intake) since start of symptoms. Out of concern he was brought to the ED (emergency department) for evaluation. Subject was admitted for rehydration.; Sender's Comments: A case of Adenovirus infection, 35 days after vaccination with 1st dose of Varicella VNS Vs Varivax, 1st dose of MMR vaccine, 1st dose of Hepatitis A vaccine and 1st dose of Prevnar 13, in a 12-month-old male patient. Based on the available information, a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow-up information has been sought.