Received Mar 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | IM / LA |
was like four days of discoloration/color turned to purple/light purple color; the area tender; The patient received the first dose of SHINGRIX in July 2023; red circular rash appeared about 2.5 inches in diameter which was below the injection site; Blisters; Flu-like symptoms; Cognitive dysfunction; color turned to blue; extreme swelling; hot to the touch; strain; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose of Shingrix in ??-JUL-2023) and Varicella vaccine (received Chicken Pox Vaccine on an unknown date). On 26-FEB-2025, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid). In FEB-2025, less than a day after receiving Shingrix, the patient experienced swelling (Verbatim: extreme swelling), blister (Verbatim: Blisters) and influenza-like symptoms (Verbatim: Flu-like symptoms). On 26-FEB-2025, the patient experienced injection site rash (Verbatim: red circular rash appeared about 2.5 inches in diameter which was below the injection site) and drug dose administration interval too long (Verbatim: The patient received the first dose of SHINGRIX in July 2023). On an unknown date, the patient experienced feeling hot (Verbatim: hot to the touch), strain (Verbatim: strain), skin discoloration (Verbatim: was like four days of discoloration/color turned to purple/light purple color), blue skin (Verbatim: color turned to blue), cognitive disturbance (Verbatim: Cognitive dysfunction) and tenderness (Verbatim: the area tender). The outcome of the injection site rash and blister were unknown and the outcome of the swelling, feeling hot, strain and cognitive disturbance were resolved (duration 5 days) and the outcome of the skin discoloration and tenderness were not resolved and the outcome of the blue skin was resolved (duration 4 days) and the outcome of the influenza-like symptoms was resolved and the outcome of the drug dose administration interval too long was not applicable. It was unknown if the reporter considered the injection site rash, swelling, feeling hot, strain, skin discoloration, blue skin, blister, influenza-like symptoms, cognitive disturbance and tenderness to be related to Shingrix. It was unknown if the company considered the injection site rash, swelling, feeling hot, strain, skin discoloration, blue skin, blister, influenza-like symptoms, cognitive disturbance and tenderness to be related to Shingrix. Additional Information: GSK Receipt Date: 10-MAR-2025 The reporter reported that the patient had extreme swelling and hot to the touch with strain around the bandage site where the pharmacist placed the injection that lasted for 5 days of swelling and heat, that was like four days of discoloration. The patient received the second dose of Shingrix on Wednesday. About 2 hours after the injection, a red circular rash appeared about 2.5 inches in diameter which was below the injection site. During the night swelling appeared and the patient experienced flu-like symptoms The swelling of the injected arm was the size of a large grapefruit. The reporter reported, this area was hot and bright / dark red which lasted for 5 days and the color turned to purple and blue for 3 to 4 more days and the swelling went down. The patient had left the bandage on that was placed by the pharmacist after the shot. During the swelling, blisters appeared around the perimeter of the bandage. The patient also experienced cognitive dysfunction after the shot which last for 5 days. The patient went to Urgent Care for treatment. At the time of reporting, the area tender, was a light purple color and the area is flat. The patient states she never had Chicken Pox. The patient had the Chicken Pox Vaccine. The patient received 2nd dose of Shingrix longer than the recommended interval which led to lengthening of vaccination schedule.