Received Feb 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
few spots around injection site; arm is hurting at the injection site; muscle aches; not feeling well; arm is painful; arm itching; having a hard time lifting her arm; Injection site bulge; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site lump in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose of Shingrix vaccine on unknown date). On 09-JAN-2025, the patient received the 2nd dose of Shingrix. On 09-JAN-2025, less than a day after receiving Shingrix, the patient experienced injection site lump (Verbatim: Injection site bulge). In JAN-2025, the patient experienced injection site erythema (Verbatim: few spots around injection site), injection site pain (Verbatim: arm is hurting at the injection site), muscle pain (Verbatim: muscle aches), feeling unwell (Verbatim: not feeling well), pain in arm (Verbatim: arm is painful), itchy upper limbs (Verbatim: arm itching) and injected limb mobility decreased (Verbatim: having a hard time lifting her arm). The outcome of the injection site lump was resolved (duration 2 days) and the outcome of the injection site erythema, injection site pain, pain in arm, itchy upper limbs and injected limb mobility decreased were unknown and the outcome of the muscle pain and feeling unwell were resolved. It was unknown if the reporter considered the injection site lump, injection site erythema, injection site pain, muscle pain, feeling unwell, pain in arm, itchy upper limbs and injected limb mobility decreased to be related to Shingrix. It was unknown if the company considered the injection site lump, injection site erythema, injection site pain, muscle pain, feeling unwell, pain in arm, itchy upper limbs and injected limb mobility decreased to be related to Shingrix. Additional Information: GSK Receipt Date: 23-JAN-2025 The reporter reported that she had her second dose of Shingrix administered on 9-JAN-2025. Immediately following the injection, the site of injection had a bulge that was present for a couple of days. Reporter stated after the injection she had muscle aches and was not feeling well. That symptoms did resolve within a few days. Two weeks after the injection her arm was painful, itching and her arm was hurting at the injection site. Also stated that she was having a hard time lifting her arm due to the pain when attempting to lift her arm. She had a few spots around the injection site.