Received Nov 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | IM / LA |
still hurts today; Hurts/soreness; she received her first dose of Shingrix on 22-MAR-2019, and just received her second dose this past Saturday, 8-NOV-2025; Itchy; Discomfort; injection site was red and swollen; injection site was red and swollen; she still has discomfort; Red; Swollen; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 22-MAR-2019). On 08-NOV-2025, the patient received the 2nd dose of Shingrix (intramuscular, left arm) .5 ml. On 08-NOV-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: she received her first dose of Shingrix on 22-MAR-2019, and just received her second dose this past Saturday, 8-NOV-2025). On 09-NOV-2025, the patient experienced injection site pain (Verbatim: still hurts today) and pain (Verbatim: Hurts/soreness). In NOV-2025, the patient experienced injection site erythema (Verbatim: injection site was red and swollen), injection site swelling (Verbatim: injection site was red and swollen), injection site discomfort (Verbatim: she still has discomfort), erythema (Verbatim: Red), swelling (Verbatim: Swollen), pruritus (Verbatim: Itchy) and discomfort (Verbatim: Discomfort). The patient was treated with ibuprofen (Adavil) and arnica montana flower (Arnica). The outcome of the injection site erythema and injection site swelling were resolving and the outcome of the injection site pain, injection site discomfort, erythema, swelling, pain, pruritus and discomfort were not resolved and the outcome of the drug dose administration interval too long was not applicable. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain, injection site discomfort, erythema, swelling, pain, pruritus and discomfort to be related to Shingrix. It was unknown if the company considered the injection site erythema, injection site swelling, injection site pain, injection site discomfort, erythema, swelling, pain, pruritus and discomfort to be related to Shingrix. Additional Information: GSK Receipt Date: 13-NOV-2025 The reporter was the patient. The patient reports that either the night of the second dose of Shingrix or the next day, she was not sure, she noticed her arm at the injection site was red and swollen which was still present but much better than it was those concerns have subsided quite a bit. The patient reports that her arm started hurting at the injection site the day after receiving the second dose of Shingrix and still hurts, her arm was also itchy which started the first day after receiving the second dose of Shingrix and was still itching today. The patient states that she still had discomfort and soreness at the injection site but it was not impacting activity. The patient also reports that starting the second day after receiving the second dose of Shingrix, she started putting Arnica Cream on her arm for the adverse effects, and has used this cream every day since through yesterday, 12-NOV-2025 she would probably use the cream. The batch number was not provided and a request for this information has been made.