Received Jun 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | PO / MO |
regurgitated dose of Rotarix during or after administration; Accidental underdose; This non-serious case was reported by a nurse via sales rep and described the occurrence of regurgitation in a child patient who received Rotavirus vaccine for prophylaxis. On an unknown date, the patient received Rotavirus vaccine (oral). On an unknown date, immediately after receiving Rotavirus vaccine, the patient experienced regurgitation (Verbatim: regurgitated dose of Rotarix during or after administration) and accidental underdose (Verbatim: Accidental underdose). The outcome of the regurgitation was resolved and the outcome of the accidental underdose was not applicable. The reporter considered the regurgitation to be related to Rotavirus vaccine. It was unknown if the reporter considered the regurgitation to be related to Rotarix Unspecified Oral Administation Device. The company considered the regurgitation to be related to Rotavirus vaccine. It was unknown if the company considered the regurgitation to be related to Rotarix Unspecified Oral Administation 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: 29-MAY-2025 This report was submitted via the online direct entry reporting system. Healthcare professional (HCP) stated that 3 patients recently have regurgitated dose of Rotarix during or after administration, which led to accidental underdose.