Age: 66.0
Sex: M
Vaccine: RSV
Symptoms: Musculoskeletal stiffness, Skin odour abnormal, Sleep disorder, X-ray limb normal
Clinical narrative: simple movement, lifting, and normal daily activities difficult; felt generally unwell; normal daily activities difficult; he still felt nowhere near the level of health prior to the vaccine; I experienced severe pain around my midsection throughout the lower back / still feeling pain in my back and around the middle; abdominal pain; Hip pain; stiffness around my midsection throughout the lower back; stiffness around my midsection throughout the lower back, abdomen; hip stiffness; fatigue; irritability; change in appetite; apathy; unpleasant change in body odor; I also experienced a night where the muscles in my leg repeatedly cramped; This non-serious case was reported by a consumer via call center representative and described the occurrence of stiff back in a 66-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 34HY5, expiry date 21-FEB-2025) and (batch number 395Y3, expiry date 28-APR-2026) for prophylaxis.   The patient's past medical history included thoracic outlet syndrome.   On 31-OCT-2023, the patient received Arexvy. On 01-NOV-2023, 1 days after receiving Arexvy, the patient experienced stiff back (Verbatim: stiffness around my midsection throughout the lower back), abdominal rigidity (Verbatim: stiffness around my midsection throughout the lower back, abdomen), stiffness hip (Verbatim: hip stiffness), fatigue (Verbatim: fatigue), irritability (Verbatim: irritability), appetite disorder (Verbatim: change in appetite), apathy (Verbatim: apathy), body odor (Verbatim: unpleasant change in body odor), leg cramps (Verbatim: I also experienced a night where the muscles in my leg repeatedly cramped), low back pain (Verbatim: I experienced severe pain around my midsection throughout the lower back / still feeling pain in my back and around the middle), abdominal pain (Verbatim: abdominal pain) and pain in hip (Verbatim: Hip pain). On an unknown date, the patient experienced mobility decreased (Verbatim: simple movement, lifting, and normal daily activities difficult), feeling unwell (Verbatim: felt generally unwell), activities of daily living impaired (Verbatim: normal daily activities difficult) and general physical health deterioration (Verbatim: he still felt nowhere near the level of health prior to the vaccine). The patient was treated with acetaminophen, meloxicam, baclofen and prednisone acetate (Prednisone). The outcome of the stiff back, abdominal rigidity, stiffness hip, fatigue, leg cramps, feeling unwell, low back pain, abdominal pain, pain in hip and general physical health deterioration were not resolved and the outcome of the irritability, appetite disorder, apathy and body odor were not reported and the outcome of the mobility decreased and activities of daily living impaired were resolving.   It was unknown if the reporter considered the stiff back, abdominal rigidity, stiffness hip, fatigue, irritability, appetite disorder, apathy, body odor, leg cramps, mobility decreased, feeling unwell, low back pain, abdominal pain, pain in hip, activities of daily living impaired and general physical health deterioration to be related to Arexvy.   It was unknown if the company considered the stiff back, abdominal rigidity, stiffness hip, fatigue, irritability, appetite disorder, apathy, body odor, leg cramps, mobility decreased, feeling unwell, low back pain, abdominal pain, pain in hip, activities of daily living impaired and general physical health deterioration to be related to Arexvy.   Additional Information: GSK Receipt Date: 16-MAY-2024 The reporter reported that the symptoms started the next day. The patient experienced severe pain and stiffness around his midsection throughout the lower back, abdomen, and hips. Pain also extended at times up the back and abdomen on the left side. This was typically worse in the morning but also present at night and other times of day. Other symptoms included fatigue, irritability, change in appetite, apathy, and an unpleasant change in body odor (which reminded him of sweating out anesthetic following surgery).  The patient also experienced a night where the muscles in his leg repeatedly cramped. The pain was initially immobilizing and made simple movement, lifting, and normal daily activities difficult, and also prohibited exercise. The patient also felt fatigue and felt generally unwell. He used a heating pad, acetaminophen, meloxicam, baclofen, and stretched. The patient usually bike, walk, go up and down steps, use hand weights and bands, did core and leg exercises, and stretch. The patient was unable to continue exercise. He was unable to maintain basic routines, such as normal cooking and cleaning. After two months, he was still feeling pain in his back and around the middle. Sometimes it seemed to concentrate on the left side. It could be worse at night and in the morning. In December he began walk and stretch more. He also started to work some with light hand weights and bands. He did try some leg exercises, and while he expected some deconditioning after two months, the response in his body did not seem natural, but instead result in greater stiffness and pain than he would normally expect. He understood that his age was a factor, but to be honest, his experience after the vaccine was markedly different, it was sort of like he aged a good number of years overnight. At the time of reporting, he still felt nowhere near the level of health prior to the vaccine and had not been able to return to his previous level of health, fitness, and activity. He still had pain in his lower back in the morning, pain at night, which could prevent sleep, and difficulty exercising. He spoke with his doctor on 20th November 2023, and he referred him to an allergist, who believed he was not allergic to the vaccine, but that it was new, and not much was known. He also referred him to a neurologist, as he had a history of thoracic outlet syndrome. The neurologist unfortunately was a specialist in movement disorders, and found nothing related to the vaccine, as well as to blood tests related to inflammatory conditions. He saw his primary care doctor for annual physical and given the similarity of symptoms to primary myelofibrosis (PMF) / Polymyalgia rheumatica, had him to a trial dose of prednisone, had an x-ray of his hands in order to rule out arthritis, and perform blood tests prior. None of the results were abnormal or suggestive of a cause for my symptoms.  His primary care doctor referred him to a rheumatologist. Further blood tests as well as x-rays of the spine and hips were normal, and in the doctor's opinion, not indicative of Polymyalgia rheumatica (PMR). The rheumatologist referred him to physical therapy to strengthen his core. He did read about a new syndrome termed autoimmune/ inflammatory syndrome induced by adjuvants (ASIA) was defined in 2011 and was associated with individual genetic predisposition and results from exposure to factors triggering hyperactive immune responses, so he was curious about that. At the time of reporting, he would continue with physical therapy. He had a follow up appointment with his primary care doctor this month and would see what next steps there might be.