Received Mar 10, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | X3Y25 | LA |
pain raising the affected arm; she had loss of range of motion in the left arm; still had pain at the injection site, she had loss of range of motion in the left arm; This non-serious case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number X3Y25, expiry date 16-JUN-2028) for prophylaxis. On 05-JAN-2026, the patient received Boostrix (left deltoid). On 05-JAN-2026, an unknown time after receiving Boostrix, the patient experienced injection site pain (Verbatim: still had pain at the injection site, she had loss of range of motion in the left arm). On 09-FEB-2026, the patient experienced pain in arm (Verbatim: pain raising the affected arm) and injected limb mobility decreased (Verbatim: she had loss of range of motion in the left arm). The outcome of the injection site pain, pain in arm and injected limb mobility decreased were not resolved. The reporter considered the injection site pain, pain in arm and injected limb mobility decreased to be related to Boostrix. It was unknown if the reporter considered the injection site pain, pain in arm and injected limb mobility decreased to be related to Boostrix Pre-Filled Syringe Device. The company considered the injection site pain, pain in arm and injected limb mobility decreased to be related to Boostrix. It was unknown if the company considered the injection site pain, pain in arm and injected limb mobility decreased to be related to Boostrix 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: 03-MAR-2026 The patient had a Boostrix vaccine. The patient called the healthcare professional called back on 19 Jan 2026 stating they still had pain at the injection site, she had loss of range of motion in the left arm, it was painful to raise the left arm. Caller reported they sent her to physical therapy on 09 Feb 2026. Caller stated the patient wants to ask GSK for reimbursement of the vaccine for all the expenses. The batch number was not provided and request for this information has been made.