Received Aug 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
swelling of arm; redness of arm; This non-serious case was reported by a nurse via sales rep and described the occurrence of swelling arm in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Pneumococcal vaccine for prophylaxis. In JUL-2025, the patient received Shingrix (unknown arm) and Pneumococcal vaccine (unknown arm). In JUL-2025, an unknown time after receiving Shingrix and Pneumococcal vaccine, the patient experienced swelling arm (Verbatim: swelling of arm) and erythema of extremities (Verbatim: redness of arm). The patient was treated with antihistamines and steroids. The outcome of the swelling arm and erythema of extremities were resolving. It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to Shingrix and Pneumococcal vaccine. It was unknown if the company considered the swelling arm and erythema of extremities to be related to Shingrix and Pneumococcal vaccine. Additional Information: GSK receipt date: 04-AUG-2025 During a routine customer interaction, it was informed about a patient had a severe swelling reaction to her shoulder and arm requiring antihistamine and oral steroid treatment after receiving her Shingrix immunization. She also reported that she had received a pneumonia immunization at the same time in her other arm. Patient was described as female, mid 60s and that this occurred within the previous month. No other information was provided.