Received Jan 21, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 292H2 | — |
swelling all over his arm; arm started to hurt/ sore arm; burning sensation; Customer noted concerns that sterile procedure was not followed when he received his vaccine; itching at the injection site; redness at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 55-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 292H2, expiry date 03-JAN-2028) for prophylaxis. On 02-JAN-2026, the patient received Boostrix (unknown arm). On 02-JAN-2026, less than a day after receiving Boostrix, the patient experienced injection site itching (Verbatim: itching at the injection site), injection site erythema (Verbatim: redness at the injection site) and wrong technique in product usage process (Verbatim: Customer noted concerns that sterile procedure was not followed when he received his vaccine). On 09-JAN-2026, the patient experienced extensive swelling of vaccinated limb (Verbatim: swelling all over his arm), pain in arm (Verbatim: arm started to hurt/ sore arm) and burning sensation (Verbatim: burning sensation). On 09-JAN-2026, the outcome of the injection site itching was resolved (duration 7 days). The outcome of the extensive swelling of vaccinated limb, injection site erythema and pain in arm were resolving and the outcome of the burning sensation was resolved and the outcome of the wrong technique in product usage process was not applicable. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site itching, injection site erythema, pain in arm and burning sensation to be related to Boostrix. It was unknown if the company considered the extensive swelling of vaccinated limb, injection site itching, injection site erythema, pain in arm and burning sensation to be related to Boostrix. Additional Information: GSK Receipt Date: 12-JAN-2026 The patient self-reported this case for himself. The customer reported that 7 days after vaccination, his arm started to hurt, and he started to experience arm soreness, a burning sensation, and swelling all over his arm. In JAN-2026, the outcome of the burning sensation was resolved. No other products were received by the patient.