Received Mar 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | LA |
that the vaccine ate her flesh and that her flesh turned black; She said that initially it was a large red ring, about 5 inches wide, and turned into an inch-wide spot; But then the patient put an unspecified salve on it and it is now irritated again; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site discoloration in a 90-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On 29-JAN-2025, the patient received RSV vaccine (left arm). On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced injection site discoloration (Verbatim: that the vaccine ate her flesh and that her flesh turned black), injection site erythema (Verbatim: She said that initially it was a large red ring, about 5 inches wide, and turned into an inch-wide spot) and injection site irritation (Verbatim: But then the patient put an unspecified salve on it and it is now irritated again). The outcome of the injection site discoloration, injection site erythema and injection site irritation were not resolved. It was unknown if the reporter considered the injection site discoloration, injection site erythema and injection site irritation to be related to RSV vaccine. It was unknown if the company considered the injection site discoloration, injection site erythema and injection site irritation to be related to RSV vaccine. Additional Information: GSK receipt date: 28-FEB-2025 The reporter was the granddaughter of the patient. The reporter reported that her grandmother was 90 years old and received the RSV vaccine made by Glasosmithkline on 29th January 2025. The brand name of the vaccine could not be confirmed and the lot number was not available. The reporter provided the name of the pharmacy (and location) of where the pharmacy where the shot was administered. The reporter could not find the pharmacy receipt to confirm the name of the product or the lot number though the pharmacy told her that it was the RSV vaccine that Glasosmithkline makes. The expiry date was not provided. The reporter stated that she had already reported the "site reaction" adverse event to the pharmacy. It was unknown if the pharmacy reported this event or not. The reporter states, that her grandmother's arm which received the injection was "rotting" and that the vaccine "ate her flesh" and that her flesh "turned black." She said that initially it was a large red ring, about 5 inches wide, and turned into an inch-wide spot. It was treated with A&D ointment and covered. When the bandage was taken off it was healing and had a scab. But then the patient put an unspecified salve on it and it was now irritated again and had left a "valley/indent" on the injected arm.