Received Oct 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 2ZF9N | — |
pneumonia; Rash in the right side of the body (specially chest and right arm pit); Muscle pain; Nerve pain; Soreness of shoulders; Soreness of neck; Nausea; Flu-like symptoms; Intense body pain; Tightness of shoulder; Tightness of neck; Brachial Neuritis; Boostrix possible three doses one in 2023; This serious case was reported by a consumer via call center representative and described the occurrence of pneumonia in a 55-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2ZF9N, expiry date 24-SEP-2023) for prophylaxis. Previously administered products included Boostrix with an associated reaction of essential tremor (received in MAR-2009 refer case US2025AMR126275) and Boostrix (received in 2015 with lot number-MO-a079B). On 02-FEB-2023, the patient received Boostrix. On 02-FEB-2023, an unknown time after receiving Boostrix, the patient experienced extra dose administered (Verbatim: Boostrix possible three doses one in 2023). On an unknown date, the patient experienced pneumonia (Verbatim: pneumonia) (serious criteria GSK medically significant), rash (Verbatim: Rash in the right side of the body (specially chest and right arm pit)), muscle pain (Verbatim: Muscle pain), nerve pain (Verbatim: Nerve pain), shoulder soreness (Verbatim: Soreness of shoulders), neck pain (Verbatim: Soreness of neck), nausea (Verbatim: Nausea), influenza-like symptoms (Verbatim: Flu-like symptoms), general body pain (Verbatim: Intense body pain), shoulder muscle stiffness (Verbatim: Tightness of shoulder), neck tightness (Verbatim: Tightness of neck) and brachial neuritis (Verbatim: Brachial Neuritis). The outcome of the pneumonia, rash, muscle pain, nerve pain, shoulder soreness, neck pain, nausea, influenza-like symptoms, general body pain, shoulder muscle stiffness, neck tightness and brachial neuritis were unknown and the outcome of the extra dose administered was not applicable. It was unknown if the reporter considered the pneumonia, rash, muscle pain, nerve pain, shoulder soreness, neck pain, nausea, influenza-like symptoms, general body pain, shoulder muscle stiffness, neck tightness and brachial neuritis to be related to Boostrix and Boostrix Pre-Filled Syringe Device. The company considered the pneumonia to be unrelated to Boostrix and Boostrix Pre-Filled Syringe Device. It was unknown if the company considered the rash, muscle pain, nerve pain, shoulder soreness, neck pain, nausea, influenza-like symptoms, general body pain, shoulder muscle stiffness, neck tightness and brachial neuritis to be related to Boostrix and 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. Linked case(s) involving the same patient: US2025AMR126275 Additional Information: GSK Receipt Date: 30-SEP-2025 A Member of the Public called asking for the contraindications of Boostrix and mentioning several side effects due to, as he thinks, a multiple administration of this vaccine although he only had the lot number of one of these. The symptoms described since the shot in 2023 was rash in the right side on the body including the right chest and a round circular rash in the right arm pit (the side where he received the vaccine), flu-like symptoms, nausea, pneumonia, tightness and soreness of neck and shoulders, muscle and nerve pain and brachial neuritis. The reporter consented to follow up.; Sender's Comments: A case of Pneumonia, unknown time after receiving unknown dose of Boostrix and Boostrix PRE-FILLED SYRINGE DEVICE in a 55-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility. US-GSK-US2025AMR126275:Same patient/Different dose