Received Feb 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | LA |
pain at the injection site; redness on her left shoulder/ redness on her face around her cheekbones; swelling on her face around her cheekbones; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose of vaccine on an unknown date). In JAN-2025, the patient received the 2nd dose of Shingrix (left arm). In JAN-2025, less than a week after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at the injection site), redness (Verbatim: redness on her left shoulder/ redness on her face around her cheekbones) and facial swelling (Verbatim: swelling on her face around her cheekbones). The patient was treated with loratadine. The outcome of the injection site pain, redness and facial swelling were unknown. It was unknown if the reporter considered the injection site pain, redness and facial swelling to be related to Shingrix. It was unknown if the company considered the injection site pain, redness and facial swelling to be related to Shingrix. Additional Information: GSK Receipt Date: 08-JAN-2025 Reporter was the patient who received her second dose of Shingrix 3 days ago (from date of reporting). She experienced pain at the injection site (left arm) and redness on her left shoulder. She said that the pain was to the touch and did not restrict any daily activities. She also had redness and swelling on her face around her cheekbones. Her pharmacist recommended to start an antihistamine for the swelling and the patient took a 10 milligram dose of loratadine.