Received May 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | LA |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | IM |
warmth at injection site; pain at injection site; redness at injection site; Itchy rash; Tiredness/she felt exhausted; hurting joints; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included ankylosing spondylitis (diagnosed in her mid 20's), covid-19 (positive for Covid after receiving her Covid vaccine) and shingles (diagnosed on 01-AUG-2024 on her buttocks and upper thigh and completely resolved.). Previously administered products included Covid-19 vaccine (received on 10-OCT-2024). On 30-APR-2025, the patient received the 2nd dose of Shingrix (left arm). On 19-DEC-2024, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid) .5 ml. On 19-DEC-2024, not applicable after receiving Shingrix and less than a day after receiving Shingrix, the patient experienced joint pain (Verbatim: hurting joints). On 01-MAY-2025, the patient experienced tiredness (Verbatim: Tiredness/she felt exhausted). On 02-MAY-2025, the patient experienced injection site warmth (Verbatim: warmth at injection site), injection site pain (Verbatim: pain at injection site), injection site erythema (Verbatim: redness at injection site) and itchy rash (Verbatim: Itchy rash). The patient was treated with clobetasol propionate (Clobetasol). The outcome of the injection site warmth, injection site pain, injection site erythema, itchy rash and joint pain were not resolved and the outcome of the tiredness was resolving. It was unknown if the reporter considered the injection site warmth, injection site pain, injection site erythema, itchy rash and tiredness to be related to Shingrix and Shingrix. It was unknown if the reporter considered the joint pain to be related to Shingrix. It was unknown if the company considered the injection site warmth, injection site pain, injection site erythema, itchy rash and tiredness to be related to Shingrix and Shingrix. It was unknown if the company considered the joint pain to be related to Shingrix. Additional Information: GSK Receipt Date: 05-MAY-2025 The patient self-reported this case. The patient received her first Shingrix vaccine in an unknown arm and her second Shingrix vaccine and she felt exhausted and tired which still has not completely resolved, but she was feeling a little better and also had pain at the injection site, it was red and warm to the touch. The patient had a rash that had traveled to her elbow and to the crease of her arm from the injection site and the rash was itchy. The patient had some Clobetasol Ointment left over from when she had shingles that she used on the rash and it seemed to help. The patient had take no meds for this disease, but did say her joints have hurt more since receiving the Shingrix vaccines and the patient will reach out to her HCP for next steps about the rash on her arm.
Medical History/Concurrent Conditions: Ankylosing spondylitis (diagnosed in her mid 20's); COVID-19 (positive for Covid after receiving her Covid vaccine); Shingles (diagnosed on 01-AUG-2024 on her buttocks and upper thigh and completely resolved.)