Age: 60.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Blood test abnormal, Borrelia test negative, Headache, Immunology test normal
Clinical narrative: Muscle weakness/ her muscles, hips and both shoulders are still very weak; Severe Pain; she could not lift her arms/ can not hardly lift anything; severe pain in both shoulders, her hips; severe muscle pain; she had a headache that has lasted for 3 weeks now; Pharmacist that administered the vaccine had to stick her 3 times to get the Arexvy vaccine into her arm; bruised arm around injection site/ Bruised around injection site; Fever around injection site; she had extreme swelling of her upper arm around injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site bruising in a 60-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included diabetes.   On 29-SEP-2023, the patient received Arexvy (right arm). On 29-SEP-2023, less than a day after receiving Arexvy, the patient experienced headache (Verbatim: she had a headache that has lasted for 3 weeks now) and wrong technique in product usage process (Verbatim: Pharmacist that administered the vaccine had to stick her 3 times to get the Arexvy vaccine into her arm). On 29-SEP-2023 18:00, the patient experienced injection site bruising (Verbatim: bruised arm around injection site/ Bruised around injection site), injection site warmth (Verbatim: Fever around injection site), injection site swelling (Verbatim: she had extreme swelling of her upper arm around injection site), shoulder pain (Verbatim: severe pain in both shoulders, her hips) and muscle pain (Verbatim: severe muscle pain). On an unknown date, the patient experienced muscle weakness (Verbatim: Muscle weakness/ her muscles, hips and both shoulders are still very weak), pain (Verbatim: Severe Pain) and mobility decreased (Verbatim: she could not lift her arms/ can not hardly lift anything). The patient was treated with prednisone. In OCT-2023, the outcome of the injection site bruising, injection site warmth and injection site swelling were resolved (duration 12 days). The outcome of the shoulder pain, muscle pain, muscle weakness, pain and headache were not resolved and the outcome of the mobility decreased was not reported and the outcome of the wrong technique in product usage process was unknown.   It was unknown if the reporter considered the injection site bruising, injection site warmth, injection site swelling, shoulder pain, muscle pain, muscle weakness, pain, mobility decreased and headache to be related to Arexvy.     It was unknown if the company considered the injection site bruising, injection site warmth, injection site swelling, shoulder pain, muscle pain, muscle weakness, pain, mobility decreased and headache to be related to Arexvy.   Additional Information: GSK receipt date: 31-OCT-2023 The patient self-reported the case. The patient that received the Arexvy vaccine in her right arm and reported that same evening, 4-5 hours after receiving the vaccine, around 6 pm, she started having severe pain in both shoulders, her hips, and muscle pain, that all hurt so bad for the 1st week after receiving the vaccine, she could not lift her arms. Her muscles, hips and both shoulders were still very weak and painful today, 31-OCT-2023 (on the day of reporting), and she could not hardly lift anything, and used to be able to do this.  Patient also reported that same evening, around 6 pm, she had extreme swelling of her upper arm, fevered arm and bruised arm, all around the injection site, that lasted for 10-12 days. Patient did state that the pharmacist that administered the vaccine had to stick her 3 times to get the Arexvy vaccine into her arm, which led to wrong technique in product usage process. Patient also reported that starting on 29-SEP-2023, less than a day after, she had a headache that has lasted for 3 weeks now, and has eased off some as of today, 31-OCT-2023 (on the day of reporting).  Patient reported that she did saw a physician on 27-OCT-2023, had blood work, shoulder and hip x-rays, was tested for Auto Immune Disease, and Lyme Disease. The blood work was mostly normal except one thing (information not provided), the Auto Immune Disease and Lyme Disease were negative.  The patient was still waiting on the x-rays.  The patient was prescribed Prednisone 2.5 MG, 1 tablet by mouth twice a day for 5 days (unknown manufacturer information).  Patient did not have any lot/expiry information or the route of administration. The reporter consented to follow up.