Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | B32NG | IM / LA |
Tetanus-like; Lockjaw; Clot blood; Muscle spasms; Chest pain; Shortness of breath; Breast cancer in 2024; This serious case was reported by a consumer via call center representative and described the occurrence of tetanus-like in a 53-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number B32NG, expiry date 13-JUN-2025) for prophylaxis. Concurrent medical conditions included hyperlipidemia and type ii diabetes mellitus (NIDDM). Concomitant products included rosuvastatin, ezetimibe (Zetia), fenofibrate and tirzepatide (Mounjaro). In APR-2023, the patient received Boostrix (intramuscular, left deltoid). On 05-MAR-2025, between 1 and 2 years after receiving Boostrix, the patient experienced tetanus-like (Verbatim: Tetanus-like) (serious criteria hospitalization and GSK medically significant), lockjaw (Verbatim: Lockjaw) (serious criteria hospitalization), clot blood (Verbatim: Clot blood) (serious criteria hospitalization and GSK medically significant), muscle spasm (Verbatim: Muscle spasms) (serious criteria hospitalization), chest pain (Verbatim: Chest pain) (serious criteria hospitalization) and shortness of breath (Verbatim: Shortness of breath) (serious criteria hospitalization). On an unknown date, the patient experienced breast cancer (Verbatim: Breast cancer in 2024) (serious criteria GSK medically significant). On 12-MAR-2025, the outcome of the tetanus-like, lockjaw, clot blood, muscle spasm, chest pain and shortness of breath were unknown (duration 7 days). The outcome of the breast cancer was resolved. It was unknown if the reporter considered the tetanus-like, lockjaw, clot blood, muscle spasm, chest pain, shortness of breath and breast cancer to be related to Boostrix. The company considered the tetanus-like, lockjaw, clot blood, muscle spasm, chest pain, shortness of breath and breast cancer to be unrelated to Boostrix. Additional Information: GSK Receipt Date: 19-MAR-2025 The patient self-reported this case. The patient reported that she received a Boostrix injection in April 2023. On 5-Mar-2025, she was admitted to the hospital with tetanus-like symptoms. She was not officially diagnosed with tetanus but suffered with lockjaw, blood clots, muscle spasms, chest pain and shortness of breath.; Sender's Comments: Tetanus, Trismus, Thrombosis, Muscle spasms, Chest pain, Dyspnoea and Breast cancer are unlisted events which are considered unrelated to GSK vaccine Boostrix.
Hyperlipidemia; Type II diabetes mellitus (NIDDM)
ROSUVASTATIN; ZETIA; FENOFIBRATE; MOUNJARO