Received Mar 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Baby chocked; Turned blue; This serious case was reported by a nurse via sales rep and described the occurrence of choking in a patient who received Rotavirus vaccine for prophylaxis. On an unknown date, the patient received Rotavirus vaccine. On an unknown date, an unknown time after receiving Rotavirus vaccine, the patient experienced choking (Verbatim: Baby chocked) (serious criteria GSK medically significant) and cyanosis (Verbatim: Turned blue). The outcome of the choking and cyanosis were not reported. It was unknown if the reporter considered the choking and cyanosis to be related to Rotavirus vaccine and Rotarix Unspecified Oral Administation Device. The company considered the choking and cyanosis to be unrelated to Rotavirus vaccine and 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: 21-FEB-2025 The nurse gave Rotatix to the patient The patient chocked and turned blue.; Sender's Comments: Choking and Cyanosis are unlisted events which are considered unrelated to GSK vaccine Rotavirus vaccine and Rotarix UNSPECIFIED ORAL ADMINISTATION DEVICE.