Received Jul 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
raised injection site; red area (a few square inches) at injection site; hot to touch the injection site; she is still tired; swollen fingers/ arm; tingling fingers; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site swelling in a female 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: raised injection site), injection site erythema (Verbatim: red area (a few square inches) at injection site), injection site warmth (Verbatim: hot to touch the injection site), tiredness (Verbatim: she is still tired), peripheral swelling (Verbatim: swollen fingers/ arm) and tingling of extremity (Verbatim: tingling fingers). The outcome of the injection site swelling, injection site erythema, injection site warmth and peripheral swelling were resolving and the outcome of the tiredness was not resolved and the outcome of the tingling of extremity was resolved. It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site warmth, tiredness, peripheral swelling and tingling of extremity to be related to Shingrix. It was unknown if the company considered the injection site swelling, injection site erythema, injection site warmth, tiredness, peripheral swelling and tingling of extremity to be related to Shingrix. Additional Information: GSK receipt date: 08-JUL-2025 The subject was the reporter, a physician, and the patient. She was a personal friend who shared that she received Shingrix the day before. In the arm where she received the injection, she had a raised, red area (a few square inches) that it was hot to the touch. She noted her fingers were swollen and tingling due to the swelling in that same arm. She had put cool compresses on the area which have helped. She had not taken any medication for this yet but planned to take Tylenol before bed. The reporter followed up with her this morning and she said the swelling was down, finger tingling was gone. She noted that she was still tired (which she did not mention originally). Overall, she said she was improved.