Received Sep 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | IM / RA |
her arm, at injection site was red; her arm, at injection site, was swollen; her arm, at injection site was painful; Slight fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Additional patient notes included No other conditions and products were reported. On 18-JUL-2025, the patient received the 1st dose of Shingrix (intramuscular, right arm). On 19-JUL-2025, 1 days after receiving Shingrix, the patient experienced injection site erythema (Verbatim: her arm, at injection site was red), injection site swelling (Verbatim: her arm, at injection site, was swollen), injection site pain (Verbatim: her arm, at injection site was painful) and fever (Verbatim: Slight fever). The outcome of the injection site erythema was not resolved and the outcome of the injection site swelling, injection site pain and fever were resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain and fever to be related to Shingrix. It was unknown if the company considered the injection site erythema, injection site swelling, injection site pain and fever to be related to Shingrix. Additional Information: GSK Receipt Date: 08-AUG-2025 The patient reported 24 hours later her arm, at injection site, was swollen, red, painful and she had a slight fever. She stated everything had resolved except for redness and was very concerned about the redness. She stated that she had been examined by her nurse practitioner and who advised her to apply ice to the affected area. However, she did not follow the advice and had not applied ice to the area. She did discuss the matter with the manager at the pharmacy where she received the injection.
Comments: No other conditions and products were reported