Received Jul 8, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | — | LA |
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | LA |
Skin lesions or lupus/skin lupus reaction; shrink and muscle caved in/ankles and feet have shrank/creasing the muscle mass in my left leg, it dented in my heels; muscle stiffened up it tightened up and painful; Skin lesions; muscle stiffened up it tightened up and painful; This serious case was reported by a consumer via call center representative and described the occurrence of cutaneous lupus erythematosus in a female patient who received RSVPreF3 adjuvanted (Arexvy) suspension for injection for prophylaxis. Co-suspect products included COVID-19 VACCINE for prophylaxis. The patient's past medical history included covid-19. On 16-OCT-2023, the patient received Arexvy (left arm) and COVID-19 VACCINE (left arm). On an unknown date, 3 months after receiving Arexvy and an unknown time after receiving COVID-19 VACCINE, the patient experienced cutaneous lupus erythematosus (Verbatim: Skin lesions or lupus/skin lupus reaction) (serious criteria GSK medically significant), muscle atrophy (Verbatim: shrink and muscle caved in/ankles and feet have shrank/creasing the muscle mass in my left leg, it dented in my heels), muscle stiffness (Verbatim: muscle stiffened up it tightened up and painful), skin lesion (Verbatim: Skin lesions) and muscle pain (Verbatim: muscle stiffened up it tightened up and painful). The outcome of the cutaneous lupus erythematosus, muscle atrophy, muscle stiffness, skin lesion and muscle pain were unknown. It was unknown if the reporter considered the cutaneous lupus erythematosus, muscle atrophy, muscle stiffness, skin lesion and muscle pain to be related to Arexvy. The reporter considered the cutaneous lupus erythematosus, muscle atrophy, muscle stiffness, skin lesion and muscle pain to be not reported if related to COVID-19 VACCINE. The company considered the cutaneous lupus erythematosus to be unrelated to Arexvy. The company considered the cutaneous lupus erythematosus, muscle atrophy, muscle stiffness, skin lesion and muscle pain to be not reported if related to COVID-19 VACCINE. Additional Information: GSK Receipt Date: 01-JUL-2026 The patient enquired whether complaints had been reported following RSV vaccination, including reports of skin lesions, lupus-like reactions, muscle loss, or allergic reactions. The patient reported that symptoms developed gradually following vaccination and initially believed they would resolve spontaneously. The patient stated that she received the RSV vaccine (Arexvy) and a SARS-CoV-2 (COVID-19) booster vaccine on the same day in October 2023. The patient reported that following vaccination in the left arm, she experienced symptoms affecting the left leg. She stated that the muscles in the left leg became stiff, tightened, and were painful. She reported that the symptoms progressed down the left leg into the ankles and feet. The patient stated that her ankles and heels appeared to have shrunk over time. She reported difficulty wearing shoes and stated that footwear became loose and came off while walking due to perceived shrinking of the left leg and foot. The patient stated that her physician advised that the symptoms could be related to a skin lesion or a lupus-related immune system reaction. She reported that she had never previously experienced similar symptoms and described herself as being in good health prior to vaccination. The patient stated that she received both vaccines after being advised that they could be administered together. She expressed concern that receiving the RSV vaccine and Moderna COVID-19 vaccine on the same day may have contributed to her symptoms. The patient reported that the condition continued to worsen rather than improve. She described a progressive decrease in muscle mass in the left leg. She reported indentations developing in the heels. The patient described a sensation of something moving around in the bottoms of her feet and heels. She stated that the symptoms began approximately 3 to 4 months after vaccination and gradually worsened thereafter. The patient reported that she did not initially seek follow-up medical evaluation because she believed the symptoms would resolve on their own. She stated that she had contracted COVID-19 in approximately February 2020 after exposure from a family member and subsequently recovered. The patient reported that healthcare providers later recommended a COVID-19 booster vaccination, and she followed that advice. The patient remained concerned about the ongoing loss of muscle mass and worsening symptoms affecting the left leg, ankle, foot, and heel following vaccination. The batch number was not provided upon follow up with the reporter; Sender's Comments: Cutaneous lupus erythematosus, 3 months after vaccination with Arexvy in a female patient. Case lacks further information on medical history, concurrent conditions and laboratory data. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought.
Medical History/Concurrent Conditions: COVID-19