Received May 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (INFANRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
| HIBV | HIB (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
| PNC | PNEUMO (PREVNAR) | PFIZER\WYETH | UNK | UNK | — |
type of palsy had a reaction to the 15 month shots; This serious case was reported by a other health professional via other manufacturer and described the occurrence of palsy in a 15-month-old female patient who received DTPa (Infanrix) for prophylaxis. Co-suspect products included Pneumococcal vaccine conj 20v (CRM197) (Prevenar 20) for prophylaxis and HIB vaccine for prophylaxis. On an unknown date, the patient received Infanrix, Prevenar 20 and HIB vaccine. On an unknown date, an unknown time after receiving Infanrix, the patient experienced palsy (Verbatim: type of palsy had a reaction to the 15 month shots) (serious criteria GSK medically significant). The outcome of the palsy was unknown. It was unknown if the reporter considered the palsy to be related to Infanrix and Infanrix Pre-Filled Syringe Device. The company considered the palsy to be unrelated 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: 06-MAY-2025 The Inbound warm transfer from agent with Pfizer Medical Information, agent relays she has a medical assistant on the line regarding DTaP (Infanrix) , HiB or Prevnar 20. The reporter stated they had a 15 month old female that had a reaction to the 15 month shots. They are trying to figure out if it is from the DTaP (Infanrix) , HiB or Prevnar 20 vaccine. The caller stated she has no patient information to provide and was just calling on behalf of the provider for information. The reporter stated the reaction was like a type of palsy. The child was followed by an allergist and this made the allergist think there was an egg or animal component that could have caused the episode. The caller was unable to clarify palsy further to include location on body. The reporter stated that the DTaP they get from GSK and HiB they get from Sanofi and does not know what doses in the series these were. The complainant does not have the product with them at the time of call. It was unknown if the reporter considered the palsy to be related to HiB or Prevnar 20 vaccine.; Sender's Comments: Paralysis is an unlisted event which is considered unrelated to GSK vaccine Infanrix and Infanrix PRE-FILLED SYRINGE DEVICE