Received Feb 4, 2026
| 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 |
DEHYDRATION CAUSED BY GINGIVOSTOMATITIS; DEHYDRATION CAUSED BY GINGIVOSTOMATITIS; This 15-month-old female subject was enrolled in a blinded study 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 31-JUL-2025 11:54, for prophylaxis. The subject received the 1st dose of MMR vaccine (subcutaneous, right deltoid) .5 ml on 31-JUL-2025 11:54, for prophylaxis. The subject received the 1st dose of Hepatitis A vaccine (intramuscular, right thigh) .5 ml on 31-JUL-2025 11:56, for prophylaxis. The subject received the 1st dose of Prevnar 13 (intramuscular, left thigh) .5 ml on 31-JUL-2025 11:56, for prophylaxis. On 31-OCT-2025, 92 days after receiving Varicella VNS Vs Varivax, MMR vaccine, Hepatitis A vaccine and Prevnar 13, the subject developed severe - grade 3 gingivostomatitis (Verbatim: DEHYDRATION CAUSED BY GINGIVOSTOMATITIS). Serious criteria included hospitalization. Additional event(s) included severe - grade 3 dehydration (Verbatim: DEHYDRATION CAUSED BY GINGIVOSTOMATITIS) on 31-OCT-2025 with serious criteria of hospitalization. The subject was treated with aciclovir (Acyclovir), ibuprofen and paracetamol (Acetaminophen). The outcome of gingivostomatitis was resolved on 07-NOV-2025. The outcome(s) of the additional event(s) included dehydration (resolved on 07-NOV-2025). The investigator considered that there was no reasonable possibility that the gingivostomatitis and dehydration 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 gingivostomatitis and dehydration may have been caused by Varicella VNS Vs Varivax, MMR vaccine, Hepatitis A vaccine and Prevnar 13. GSK Receipt Date: 28-Jan-2026 Subject was hospitalized due to dehydration caused by gingivostomatitis.; Sender's Comments: A case of Stomatitis and Dehydration, 92 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 15-month-old female subject. 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.