Received Mar 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
out and sick for like a month; tummy issues; lethargy; This non-serious case was reported by a nurse via call center representative and described the occurrence of lethargy in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. Previously administered products included Covid vaccine (after the second dose). Concurrent medical conditions included autoimmune disorder, ehlers-danlos syndrome, lyme disease, drug allergy (gelatin) and meat allergy. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced lethargy (Verbatim: lethargy), sickness (Verbatim: out and sick for like a month) and abdominal disorder (Verbatim: tummy issues). The outcome of the lethargy was resolved (duration 3 weeks) and the outcome of the sickness and abdominal disorder were unknown. It was unknown if the reporter considered the lethargy, sickness and abdominal disorder to be related to Boostrix and Boostrix Pre-Filled Syringe Device. It was unknown if the company considered the lethargy, sickness and abdominal disorder 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. Additional Information: GSK Receipt Date: 05-MAR-2025 The retired nurse stated her spouse has a gelatin allergy and last year was given a dose of Tdap vaccine instead of just tetanus and had a bad reaction. This occurred last year, and she was out, and sick for like a month. The brand of Tdap administered was unknown. The patient had immediately had to hit the inhaler way more than she should have, which lasted for two days, use of Benadryl constantly and lethargy for three weeks after, as well as tummy issues, which she declined to provide further details about. The patient had a history of reaction to the Covid vaccine after the second dose, and her provider told her she should not get any booster doses. The patient had a history of untreated Lyme disease, which originated approximately 30 years ago, and resulted in gelatin, meat, and alpha gal allergies as well as EDS (clarified as Ehlers-danlos syndrome) and autoimmune issues. Brand of Tdap was unknown to nurse. It was difficult to keep the nurse on-topic, and specialist was unable to get permission for safety follow up. No further details were provided.
Autoimmune disorder; Drug allergy (gelatin); Ehlers-Danlos syndrome; Lyme disease; Meat allergy