Received Apr 9, 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 |
optic pathway-hypothalamic glioma in child; This 15-month-old male subject was enrolled in a blinded study titled A Phase 3a, observer-blind, randomized, controlled study to evaluate the 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 16-DEC-2025 11:43, for prophylaxis. The subject received the 1st dose of MMR vaccine (subcutaneous, right deltoid) .5 ml on 16-DEC-2025 11:43, for prophylaxis. The subject received the 1st dose of Hepatitis A vaccine (intramuscular, right thigh) .5 ml on 16-DEC-2025 11:43, for prophylaxis. The subject received the 1st dose of Prevnar 13 (intramuscular, left thigh) .5 ml on 16-DEC-2025 11:43, for prophylaxis. Concurrent medical conditions included congenital nystagmus. On 01-APR-2026, 106 days after receiving Varicella VNS vs Varivax, MMR vaccine, Hepatitis A vaccine and Prevnar 13, the subject developed severe - grade 3 optic glioma (Verbatim: optic pathway-hypothalamic glioma in child). Serious criteria included life threatening and clinically significant/intervention required. The outcome of optic glioma was not resolved. The investigator considered that there was no reasonable possibility that the optic glioma 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 optic glioma may have been caused by Varicella VNS vs Varivax, MMR vaccine, Hepatitis A vaccine and Prevnar 13. GSK Receipt Date: 07-APR-2026 Child with medical history of nystagmus left esotropia since 4 months of age, seeing ophthalmology specialists. MD (Medical Doctor) ordered MRI (Magnetic Resonance Imaging) in JAN-2026 which was not completed until 01-APR-2026 which diagnosed a glioma. Subject had telehealth appointment with oncology on 06-APR-2026 diagnoses 5-month-old with a newly diagnosed bilateral optic pathway/hypothalamic glioma. No stigmata of NF1. Subject had nystagmus since 4 months old. Subject was otherwise generally healthy and had normal growth. Subject did had some mild global developmental delay, but no focal neurologic signs aside from visual loss. No labs or other information present as of today. Subject was in process of scheduling for biopsy and chemotherapy.; Sender's Comments: A case of Optic glioma, 106 days after receiving 1st dose of Varicella VNS vs Varivax, MMR vaccine, Hepatitis A vaccine and Prevnar 13 in a 15-month-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and absence of biological plausibility.
Congenital nystagmus