Received May 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (INFANRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
colic might not be about an upset stomach/ was in agony for four months; Screaming; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of colic in a patient who received DTPa (Infanrix) for prophylaxis. On an unknown date, the patient received Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced colic (Verbatim: colic might not be about an upset stomach/ was in agony for four months) and screaming (Verbatim: Screaming). The outcome of the colic was not reported and the outcome of the screaming was resolved. The reporter considered the colic and screaming to be related to Infanrix and Infanrix Pre-Filled Syringe Device. The company considered the colic and screaming to be related to Infanrix and Infanrix Pre-Filled Syringe 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: 30-APR-2025 This case was reported by the reporter via interactive digital media. The reporter (parent) think colic might not be about an upset stomach. The parent stated that kid was in agony for four months and was screaming for hours. This case is linked with US2025AMR055504, reported by same reporter.; Sender's Comments: US-GSK-US2025AMR055504:same reporter