Received Jul 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 9K34M | — |
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | H4279 | — |
fainted seconds after receiving the vaccines; very limp; This serious case was reported by a pharmacist via other manufacturer and described the occurrence of fainting in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number H4279, expiry date 30-AUG-2027) for prophylaxis. Co-suspect products included HBV (Engerix B) (batch number 9K34M, expiry date 05-SEP-2025) for prophylaxis. On an unknown date, the patient received Boostrix .5 ml and Engerix B .5 ml. On an unknown date, an unknown time after receiving Boostrix and Engerix B, the patient experienced fainting (Verbatim: fainted seconds after receiving the vaccines) (serious criteria GSK medically significant) and limping (Verbatim: very limp). The outcome of the fainting and limping were not reported. It was unknown if the reporter considered the fainting and limping to be related to Boostrix and Engerix B. The company considered the fainting to be unrelated to Boostrix and Engerix B. It was unknown if the company considered the limping to be related to Boostrix and Engerix B. Additional Information: GSK Receipt Date: 14-JUL-2025 A pharmacist had called and reported an adverse event for Boostrix and Engerix. The healthcare professional had stated that a patient had come in to receive vaccines and had expressed nervousness and had been scared to receive an injection. The pharmacist had left the patient in the room with another pharmacist, but shortly after leaving the room, the healthcare professional (HCP) had heard a scream. The other pharmacist, who had been left in the room with the patient, had opened the door and requested assistance because the patient had fainted seconds after receiving the vaccines Boostrix and Engerix. The HCP had called an ambulance, and the patient had woken up upon arrival of the emergency personnel and had been able to answer questions but had appeared very limp. The patient had been transported to the hospital due to fainting, and the HCP had been unable to provide any additional details or information during the call.; Sender's Comments: A case of Syncope, after receiving Boostrix and Engerix B , in a patient. Based on the available information a possible causality that the events were caused by the GSK product cannot be ascertained. Further follow up information has been sought.