Received May 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | IM / LA |
Injection site pain; redness at the injection site; swelling at the injection site; redness at the injection site that spread to the top of his left shoulder; swelling at the injection site that spread to the top of his left shoulder; dizzy spell; general malaise; joint pain; throat congestion; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received in FEB-2025, for tolerance refer linked case US2025063423). On 19-MAY-2025, the patient received the 2nd dose of Shingrix (intramuscular, left arm) .5 ml. On 20-MAY-2025, 1 days after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection site pain), injection site erythema (Verbatim: redness at the injection site), injection site swelling (Verbatim: swelling at the injection site), erythema of extremities (Verbatim: redness at the injection site that spread to the top of his left shoulder), swelling arm (Verbatim: swelling at the injection site that spread to the top of his left shoulder), dizzy spells (Verbatim: dizzy spell), general malaise (Verbatim: general malaise), joint pain (Verbatim: joint pain) and upper respiratory tract congestion (Verbatim: throat congestion). The patient was treated with celecoxib (Celebrex). Rechallenge with Shingrix was positive. The outcome of the injection site pain, injection site erythema, injection site swelling, erythema of extremities, swelling arm, general malaise, joint pain and upper respiratory tract congestion were not resolved and the outcome of the dizzy spells was resolved. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, erythema of extremities, swelling arm, dizzy spells, general malaise, joint pain and upper respiratory tract congestion to be related to Shingrix. It was unknown if the company considered the injection site pain, injection site erythema, injection site swelling, erythema of extremities, swelling arm, dizzy spells, general malaise, joint pain and upper respiratory tract congestion to be related to Shingrix. Linked case(s) involving the same patient: US2025063423 Additional Information: GSK Receipt Date: 21-MAY-2025 The patient self-reported this case for himself. The patient reported he received the second Shingrix vaccine and the next day he had injection site pain, redness and swelling at the injection site that spread to the top of his left shoulder that has not resolved. The patient had a dizzy spell when getting off his bike that has resolved in MAY-2025. The patient felt general malaise and joint pain that has not resolved. The patient also reported throat congestion that might or might not be related to the Shingrix. The patient took a Celebrex yesterday (day before reporting). The patient would contact his HCP if these symptoms were not resolved.; Sender's Comments: US-GSK-US2025063423:case for 1st dose