Received Oct 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | UNK | LA |
| FLU3 | INFLUENZA (SEASONAL) (FLUBLOK) | SANOFI PASTEUR | UNK | UNK | IM / LA |
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | H4K3S | IM / RA |
pain at the injection site; Injection site swelling; Injection site bruising; Itchy/a itching on her left arm/ Injection site itching; Injection site redness; has lump the size of a golf ball/injection site mass; irritated; Her arm hurts to lift it; she experienced a itching on her left arm; dark/red; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number H4K3S) for prophylaxis. Co-suspect products included Influenza vaccine rHA 3v (baculovirus) (Flublok) for prophylaxis and COVID-19 VACCINE for prophylaxis. The patient's past medical history included covid-19 (COVID did attack her lungs and was aggravated bronchial asthma) and bronchial asthma (last time bronchial asthma affected the consumer was 15 years ago). Previously administered products included iron infusion. Concurrent medical conditions included blood pressure and thyroid disorder. On 16-SEP-2025, the patient received Boostrix (intramuscular, right arm), Flublok (intramuscular, left arm) and COVID-19 VACCINE (left arm). In SEP-2025, an unknown time after receiving Boostrix and not applicable after receiving Flublok and COVID-19 VACCINE, the patient experienced injection site pain (Verbatim: pain at the injection site), injection site swelling (Verbatim: Injection site swelling), injection site bruising (Verbatim: Injection site bruising), injection site itching (Verbatim: Itchy/a itching on her left arm/ Injection site itching), injection site erythema (Verbatim: Injection site redness), injection site lump (Verbatim: has lump the size of a golf ball/injection site mass), irritability (Verbatim: irritated), pain upon movement (Verbatim: Her arm hurts to lift it), pruritus (Verbatim: she experienced a itching on her left arm) and skin discoloration (Verbatim: dark/red). The patient was treated with hydrocortisone. The outcome of the injection site pain, injection site swelling, injection site bruising, injection site itching, injection site erythema, injection site lump, irritability, pain upon movement, pruritus and skin discoloration were not resolved. It was unknown if the reporter considered the injection site pain, injection site swelling, injection site bruising, injection site itching, injection site erythema, injection site lump, irritability, pain upon movement, pruritus and skin discoloration to be related to Boostrix and Boostrix Pre-Filled Syringe Device. It was unknown if the reporter considered the irritability, pain upon movement, pruritus and skin discoloration to be related to Flublok and COVID-19 VACCINE. It was unknown if the company considered the injection site pain, injection site swelling, injection site bruising, injection site itching, injection site erythema, injection site lump, irritability, pain upon movement, pruritus and skin discoloration to be related to Boostrix and Boostrix Pre-Filled Syringe Device. It was unknown if the company considered the irritability, pain upon movement, pruritus and skin discoloration to be related to Flublok and COVID-19 VACCINE. 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: 23-SEP-2025, 24-SEP-2025 and 25-SEP-2025. The consumer was the reporter. The reporter states she was vaccinated with a tetanus vaccine, flu vaccine and covid vaccine on 16 SEP 2025. She had the flu shot and covid vaccine administered in the left arm. The tetanus vaccine was administered in her right arm. The consumer was unable to provide the name/manufactures of the vaccines that were administered and could not provide the lot numbers. The consumer state that she experienced a itching on her left arm, however, that has resolved. The consumer state that a few days later her right arm started itching. The consumer stated that her right arm at the injection site is painful, itchy, swollen, red, bruised, has lump the size of a golf ball, is irritated and her arm hurts to lift it. The reporter stated that she went back to the vaccinating pharmacy for examination and was told to put a warm compress on the areas and apply hydrocortisone cream for the itching. Consumer stated that she took blood pressure medication, thyroid medication, and an iron infusion (name/frequency/dose not disclosed.)
Blood pressure; Thyroid disorder
Medical History/Concurrent Conditions: Bronchial asthma (last time bronchial asthma affected the consumer was 15 years ago); COVID-19 (COVID did attack her lungs and was aggravated bronchial asthma)