Received Feb 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV1 | ROTAVIRUS (ROTARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | HP495 | — |
patient projectile vomited immediately after giving it to her; Accidental underdose; This non-serious case was reported by a nurse via call center representative and described the occurrence of vomiting projectile in a 2-month-old female patient who received Rota (Rotarix liquid formulation) (batch number HP495, expiry date 17-MAY-2026) for prophylaxis. On 17-JAN-2025, the patient received Rotarix liquid formulation. On 17-JAN-2025, immediately after receiving Rotarix liquid formulation, the patient experienced vomiting projectile (Verbatim: patient projectile vomited immediately after giving it to her) and accidental underdose (Verbatim: Accidental underdose). The outcome of the vomiting projectile and accidental underdose were unknown. It was unknown if the reporter considered the vomiting projectile to be related to Rotarix liquid formulation and Rotarix Pre-Filled Oral Applicator Device. It was unknown if the company considered the vomiting projectile to be related to Rotarix liquid formulation and Rotarix Pre-Filled Oral Applicator Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 17-JAN-2025 The registered nurse stated they attempted to administer Rotarix to 2 month old and the patient projectile vomited immediately after giving it to her which led to Accidental underdose. The vaccine administration facility is the same as primary reporter.