Received Mar 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
severe localized reaction of the injection site that had a large area of swelling that hardened; severe localized reaction of the injection site that had a large area of swelling that hardened; impacted the pigmentation of that area of the patient's arm; adult approximately 45 years of age received Shingrix; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site swelling in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site swelling (Verbatim: severe localized reaction of the injection site that had a large area of swelling that hardened), injection site induration (Verbatim: severe localized reaction of the injection site that had a large area of swelling that hardened), injection site pigmentation changes (Verbatim: impacted the pigmentation of that area of the patient's arm) and inappropriate age at vaccine administration (Verbatim: adult approximately 45 years of age received Shingrix). The outcome of the injection site swelling, injection site induration and injection site pigmentation changes were resolved and the outcome of the inappropriate age at vaccine administration was not applicable. It was unknown if the reporter considered the injection site swelling, injection site induration and injection site pigmentation changes to be related to Shingrix. It was unknown if the company considered the injection site swelling, injection site induration and injection site pigmentation changes to be related to Shingrix. Additional Information: GSK Receipt Date: 14-MAR-2025 An adult approximately 45 years of age patient had been vaccinated with Shingrix dose 1 which led to inappropriate age at vaccine administration. The patient indicated that he had a severe localized reaction of the injection site that had a large area of swelling that hardened and the swelling was so significant if impacted the pigmentation of that area of the patient's arm. It was unknown if this was dose 1 or dose 2 of Shingrix. If it was dose 1 then it was unknown if patient returned for dose 2. The patient had now recovered.