Received May 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 7kd5b | IM / LA |
| TDAP | TDAP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 7kd5b | — |
pain; Paralysis; hives; This serious case was reported by a consumer and described the occurrence of pain in a 37-year-old male patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number 7kd5b, expiry date 14-JUN-2027) for prophylaxis. On 18-APR-2025, the patient received Tdap Vaccine .5 ml. On 18-APR-2025, less than a day after receiving Tdap Vaccine, the patient experienced pain (Verbatim: pain) (serious criteria clinically significant/intervention required), paralysis (Verbatim: Paralysis) (serious criteria GSK medically significant and clinically significant/intervention required) and hives (Verbatim: hives) (serious criteria clinically significant/intervention required). The outcome of the pain, paralysis and hives were not resolved. It was unknown if the reporter considered the pain, paralysis and hives to be related to Tdap Vaccine. The company considered the pain and hives to be related to Tdap Vaccine. The company considered the paralysis to be unrelated to Tdap Vaccine. Additional Information: GSK Receipt Date: 03-MAY-2025 The reporter reported that the patient had this vaccine before with no issues. No issues with any other vaccines in his life. This was sudden and abrupt impeding his quality of life.; Sender's Comments: Pain and Urticaria are listed events which, due to the following criteria (insufficient information regarding medical history, concurrent conditions and concomitant medications) are considered unrelated to GSK Tdap vaccine. Paralysis is an unlisted event which is considered unrelated to GSK Tdap vaccine.