Received Apr 28, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTPPVHBHPB | DTAP+IPV+HIB+HEPB (VAXELIS) | MSP VACCINE COMPANY | 1 | U8314AA | IM / LL |
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | 1 | MH1445 | IM / RL |
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | 1 | Z007664 | PO / MO |
| DTPPVHBHPB | DTAP+IPV+HIB+HEPB (VAXELIS) | MSP VACCINE COMPANY | 1 | U8314AA | IM / LL |
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | 1 | MH1445 | IM / RL |
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | 1 | Z007664 | PO / MO |
Staphylococcal scalded skin syndrome; Leukocytosis; Skin lesion; Rash; Blood culture negative; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 20-APR-2026 with the following reference number: 2886678. The original narrative from the sender is as below: Infant had a rash in diaper area, folds moist with a few satellite lesions perianal. Received vaccines Vaxelis, Prevnar 20, and Rota. Patient went to ER with spreading rash to her trunk on 2/5/2026. Leukocytosis and was admitted. Treated for Scalded Skin Syndrome. No fevers. Blood culture negative. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events 'Staphylococcal scalded skin syndrome', "Leukocytosis'', 'Skin lesion' and 'Rash'. Due to the nature of the events, the causality between 'Blood culture negative' and Vaxelis was not applicable. No further information is expected.; Sender's Comments: Staphylococcal scalded skin syndrome, Skin lesion and Rash were reported as serious. Leukocytosis and Blood culture negative were assessed as non-serious. Staphylococcal scalded skin syndrome, Skin lesion, Leukocytosis and Blood culture negative are unlisted, whereas Rash is listed for Vaxelis, as per the Reference Safety Information (CCDS). Considering the plausible temporal sequence (events occurred 10 days after the vaccination), the current knowledge of the vaccine (Rash is listed for Vaxelis), and despite the co-suspect vaccines (Prevnar 20 and Rotateq) as confounding factors, and despite the existence of alternative explanations (prior condition of diaper rash), the causal relationship between Vaxelis and the events of Staphylococcal scalded skin syndrome, Leukocytosis, Skin lesion and Rash cannot be excluded and is assessed as related. Blood culture negative causality is assessed as not applicable, per convention. 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
Medical History/Concurrent Conditions: Diaper rash