Received Apr 28, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTPPVHBHPB | DTAP+IPV+HIB+HEPB (VAXELIS) | MSP VACCINE COMPANY | 1 | U7836AA | IM / RL |
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | MM0534 | IM / LL |
| RV1 | ROTAVIRUS (ROTARIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 94A7Z | PO / MO |
| DTPPVHBHPB | DTAP+IPV+HIB+HEPB (VAXELIS) | MSP VACCINE COMPANY | 1 | U7836AA | IM / RL |
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | MM0534 | IM / LL |
| RV1 | ROTAVIRUS (ROTARIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 94A7Z | PO / MO |
Spina bifida; RASH; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 20-APR-2026 with the following reference number: 2884285. The original narrative from the sender is as below: Patient started w/ rash around 11:30 pm on 1/22/26 from head torso and arms receded and was back again 1/23/24 thru 1-26-26. Per provider not sure if from vaccines or Tide pod. Patient has been diagnosed w/ spina bifida. Sent to Allergist. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events 'Spina bifida' and 'Rash'. No further information is expected.; Sender's Comments: Spina bifida was assessed as serious, due to being medically significant. Rash was reported as non-serious. Spina bifida is unlisted, whereas the Rash is listed for Vaxelis, as per the Reference Safety Information (CCDS). Considering the plausible temporal sequence (event occurred 1 day after the vaccination), the current knowledge of the vaccine (Rash is listed for Vaxelis), and despite the co-suspect vaccines (Prevnar 20 and Rotarix) as confounding factors, the causal relationship between Vaxelis and the event of Rash cannot be excluded and is assessed as related. Spina bifida is a congenital neural tube defect formed during early embryogenesis (weeks 34 of gestation), long before postnatal vaccination is administered. Therefore, the causal relationship between Vaxelis and the event of Spina bifida is assessed as not related. This single individual case safety report does not modify the benefit/risk balance of this product. Therefore, no change in the label or other measures is recommended at this time. However, the company will continue to monitor all respective reports received and, based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.
Prophylaxis