Received May 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | IM / RA |
a big red circle rash at the injection site; Redness; "it is hot, hard and swollen; "it is hot, hard and swollen ( at injection site); "it is hot, hard and swollen ( at injection site); Sore throat; it was extremely itchy yesterday; soreness and pain at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of sore throat in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 28-APR-2025, the patient received Shingrix (intramuscular, right arm) .5 ml. On 28-APR-2025, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: soreness and pain at the injection site). On 30-APR-2025, the patient experienced injection site itching (Verbatim: it was extremely itchy yesterday). On 01-MAY-2025, the patient experienced sore throat (Verbatim: Sore throat). On an unknown date, the patient experienced injection site rash (Verbatim: a big red circle rash at the injection site), injection site erythema (Verbatim: Redness), injection site swelling (Verbatim: "it is hot, hard and swollen), injection site warmth (Verbatim: "it is hot, hard and swollen ( at injection site)) and injection site induration (Verbatim: "it is hot, hard and swollen ( at injection site)). The outcome of the sore throat, injection site erythema and injection site pain were not resolved and the outcome of the injection site rash, injection site itching, injection site swelling, injection site warmth and injection site induration were resolving. It was unknown if the reporter considered the sore throat, injection site rash, injection site erythema, injection site pain, injection site itching, injection site swelling, injection site warmth and injection site induration to be related to Shingrix. It was unknown if the company considered the sore throat, injection site rash, injection site erythema, injection site pain, injection site itching, injection site swelling, injection site warmth and injection site induration to be related to Shingrix. Additional Information: GSK Receipt Date 01-MAY-2025: It was reported that the patient received the 1st dose of Shingrix in her right arm on April 28th, 2025, at a local pharmacy. She reports she has "a big red circle rash at the injection site". She reports, "it is hot, hard and swollen." The patient reports soreness and pain at the injection site. The patient reports "it was extremely itchy yesterday, but it is getting better". The patient reports the symptoms have improved but the pain, redness, and soreness are still present. The patient reports, "on the reporting day I have a sore throat, asked is this related to the vaccine. The patient was referred to HCP.