Age: 73.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Myalgia
Clinical narrative: cannot walk; she is still experiencing breakthrough pain while sleeping at night.; Autoimmune response (per doctor); she started experiencing severe pain in shoulders, hips, knees, ankles, and muscle pain; she started experiencing severe pain in shoulders, hips, knees, ankles, and muscle pain; This serious case was reported by a consumer via call center representative and described the occurrence of autoimmune disorder in a 73-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number mz775, expiry date 22-FEB-2025) for prophylaxis.   Concurrent medical conditions included arthritis (Mild) and penicillin allergy (Allergic to Penicillin and Tetracycline). Concomitant products included estradiol valerate (Estradiol), cod-liver oil, retinol, tocopherol, ubidecarenone, vitamin d nos (Co Q 10), calcium fructoborate, chondroitin sulfate sodium, glucosamine hydrochloride, hyaluronic acid (Move Free Joint Health), thyroid (Armour Thyroid) and rosuvastatin calcium (Rosuvastatin).   On 26-NOV-2023, the patient received Arexvy (right arm). On 27-NOV-2023, 1 days after receiving Arexvy, the patient experienced autoimmune disorder (Verbatim: Autoimmune response (per doctor)) (serious criteria GSK medically significant), arthralgia (Verbatim: she started experiencing severe pain in shoulders, hips, knees, ankles, and muscle pain) and muscle pain (Verbatim: she started experiencing severe pain in shoulders, hips, knees, ankles, and muscle pain). On an unknown date, the patient experienced unable to walk (Verbatim: cannot walk) and breakthrough pain (Verbatim: she is still experiencing breakthrough pain while sleeping at night.). The patient was treated with methylprednisolone acetate, naproxen sodium (Naprosyn) and paracetamol (Tylenol). The outcome of the autoimmune disorder, arthralgia, muscle pain and unable to walk were unknown and the outcome of the breakthrough pain was not resolved.   It was unknown if the reporter considered the autoimmune disorder, arthralgia, muscle pain, unable to walk and breakthrough pain to be related to Arexvy.     It was unknown if the company considered the autoimmune disorder, arthralgia, muscle pain, unable to walk and breakthrough pain to be related to Arexvy.   Additional Information: GSK receipt date: 14-DEC-2023 The patient self-reported this case.  The reporter reported that received a steroid shot in left knee two weeks prior to receiving the Arexvy vaccine.  The reporter reported that the first 24 hours after having the Arexvy administered and experiencing severe pain in shoulders, hips, knees, ankles, and muscle pain.  The patient went to orthopedic specialist and was diagnosed with autoimmune response to having Arexvy vaccine. The consumer reported that for this condition (autoimmune condition) the physician put her on Methylprednisolone 4 mg, 6-day pack. Naprosyn 500 mg and Tylenol 325 mg both of those to be taken at bedtime for the condition.  The patient stated that pain was an 11 out of 10 on a pain scale. Other medications listed were provided by patient but had nothing to do with the autoimmune response.  The patient was experiencing breakthrough pain while sleeping at night.  The reporter consented to follow up.