Received Oct 24, 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 |
HAND FOOT AND MOUTH DISEASE; This 12-month-old female subject was enrolled in a 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 30-SEP-2025 15:46, for prophylaxis. The subject received the 1st dose of MMR vaccine (subcutaneous, right deltoid) .5 ml on 30-SEP-2025 15:46, for prophylaxis. The subject received the 1st dose of Hepatitis A vaccine (intramuscular, right thigh) .5 ml on 30-SEP-2025 15:46, for prophylaxis. The subject received the 1st dose of Prevnar 13 (intramuscular, left thigh) .5 ml on 30-SEP-2025 15:46, for prophylaxis. Previously administered products included VAXELIS (Subject received VAXELIS 1st dose on 25-NOV-2024, 2nd dose on 30-JAN-2025, 3rd dose on 25-MAR-2025 0.5 ml single via intramuscular route for indication of prophylaxis.), PCV20 (Subject received PCV20 1st dose on 25-NOV-2025, 2nd dose on 30-JAN-2025, 3rd dose on 25-MAR-2025 0.5 ml single via Intramuscular route for indication of prophylaxis.) and ROTATEQ (Subject received ROTATEQ 1st dose on 25-NOV-2025, 2nd dose on 30-JAN-2025, 3rd dose on 25-MAR-2025 2 ml single via oral route for indication of prophylaxis.). On 06-OCT-2025, 6 days after receiving Varicella VNS Vs Varivax, MMR vaccine, Hepatitis A vaccine and Prevnar 13, the subject developed severe - grade 3 hand, foot and mouth disease (Verbatim: HAND FOOT AND MOUTH DISEASE). Serious criteria included hospitalization. The outcome of hand, foot and mouth disease was not resolved. The investigator considered that there was no reasonable possibility that the hand, foot and mouth disease 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 hand, foot and mouth disease may have been caused by Varicella VNS Vs Varivax, MMR vaccine, Hepatitis A vaccine and Prevnar 13. Linked case(s) involving the same subject: US2025GSK132358 GSK receipt date: 16-OCT-2025 On 16-OCT-2025, the case US2025GSK132358 was identified as duplicate of US2025135064. The case was US2025GSK132358 was prepared for deletion, all future correspondence will be added to the case US2025GSK132358.; Sender's Comments: A case of Hand-foot-and-mouth disease, 6 days after receiving 1st dose of Varicella VNS Vs Varivax, 1st dose of MMR vaccine and 1st dose of Hepatitis A vaccine, 1st dose of Prevnar 13, in a 12-month-old female subject. Causal relation is indeterminate considering multiple vaccines given concomitantly.