Age: 49.0
Sex: M
Vaccine: FLUC3
Symptoms: Sleep disorder, Spinal pain, X-ray
Clinical narrative: Inflammation; PMR; Sleep; Lime disease; Difficulty dressing, etc.; TMR; Widespread joint pain starting from his knees to his hands, shoulders and to his hips; Pain in upper spine; Thumb was aching; Could not kneel down/couldn't bend his knees/could not move, walk like a pinvin; Immobile; This spontaneous case was received on 16-Mar-2021 from other non-health professional (consumer) via Med Communication (reference number: SEQW21-01003) and concerned a 49-year-old, male patient.  The patient's previous historical vaccine included Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent) in 2019 after which the patient experienced goat. The patient's past medical history included bout of goat and back surgery. The patient fell in Sep-2020 and was admitted to hospital.  The patient's concomitant medication was Advil (ibuprofen), used for an unknown indication.   On 12-Sep-2020, the patient was vaccinated with Flucelvax Quadrivalent (dose: 0.5 ml, route of administration and anatomical location: not reported) for prevention of seasonal influenza. The batch number was not reported.   On an unspecified date in Sep-2020, within a week after receiving Flucelvax Quadrivalent, the patient could not kneel down, bend his knees and his thumb was aching.  On an unspecified date in Oct-2020, with each passing week after receiving Flucelvax Quadrivalent, the pain was progressing and the patient started having pain in upper spine and widespread joint pain starting from his knees to his hands, shoulders and down to his hips and his back. It was told that it was possible TMR (to be clarified), but that was difficulty diagnosing.  On an unspecified date in 2020, reported by Thanksgiving, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient was immobile.  On an unspecified date in early Oct-2020 and Nov-2020, the patient could not move and walk like a pinvin. The patient was treated with minocycline and had more movement.  On an unspecified date in Nov-2020, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient had difficulty dressing.  On an unspecified date, an unknown amount of time after receiving Flucelvax Quadrivalent, it was thought that it could be Lime's disease. The patient was also tested for autoimmune diseases and no result was provided. The patient was treated with prednisone, at a dose of 40 mg. It was a tapering dose which went down to 20 mg and after that the patient was receiving 15 mg, which the patient did not take as prescribed and splitted as the pain was worse in the morning and took 10 mg in the morning and 5 mg at night.   On an unspecified date, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient developed sleep disorder and was treated with Flexeril (cyclobenzaprine hydrochloride), a muscle relaxant for sleep disorder. The blood tests revealed inflammation. The X-ray and testing for testing for Lyme's disease revealed that the patient was diagnosed polymyalgia rheumatica (PMR).  At the time of initial reporting on 16-Mar-2021, the patient was recovering from the event 'mobility decreased'.  The outcome of all other events was not reported.  The reporter did not provide a causality assessment.  All events were assessed as serious due to seriousness criterion of medically significance.  This case is linked with case 202102012 (due to the same patient).  Company comment: A 49-year-old, male patient was vaccinated with Flucelvax Quadrivalent. Within a week after receiving Flucelvax Quadrivalent, the patient could not knee down, bend his knees and his thumb was aching. With each passing week after receiving Flucelvax Quadrivalent, the pain was progressing and the patient started having pain in upper spine and widespread joint pain starting from his knees to his hands, shoulders and down to his hips and his back. It was told that it was possible TMR (to be clarified, Adverse event). An unknown amount of time after receiving Flucelvax Quadrivalent, the patient was immobile. The patient could not move, had difficulty dressing. It was thought that it could be Lyme's disease. The patient developed sleep disorder and was treated with Flexeril. The blood tests revealed inflammation. The patient was diagnosed polymyalgia rheumatica (PMR). Based on biological and chronological plausibility, causality is assessed as possibly related for polymyalgia rheumatica, arthralgia, mobility decreased, immobile, spinal pain, pain in extremity, inflammation and activities of daily living impaired. Causality is unassessable for Adverse event, due to lack of information. Sleep disorder is assessed as not related to the suspect vaccine. The event of Lyme's disease is assessed as not related to the suspect vaccine, due to biological implausibility.; Sender's Comments: A 49-year-old, male patient was vaccinated with Flucelvax Quadrivalent. Within a week after receiving Flucelvax Quadrivalent, the patient could not knee down, bend his knees and his thumb was aching. With each passing week after receiving Flucelvax Quadrivalent, the pain was progressing and the patient started having pain in upper spine and widespread joint pain starting from his knees to his hands, shoulders and down to his hips and his back. It was told that it was possible TMR (to be clarified, Adverse event). An unknown amount of time after receiving Flucelvax Quadrivalent, the patient was immobile. The patient could not move, had difficulty dressing. It was thought that it could be Lyme's disease. The patient developed sleep disorder and was treated with Flexeril. The blood tests revealed inflammation. The patient was diagnosed polymyalgia rheumatica (PMR). Based on biological and chronological plausibility, causality is assessed as possibly related for polymyalgia rheumatica, arthralgia, mobility decreased, immobile, spinal pain, pain in extremity, inflammation and activities of daily living impaired. Causality is unassessable for Adverse event, due to lack of information. Sleep disorder is assessed as not related to the suspect vaccine. The event of Lyme's disease is assessed as not related to the suspect vaccine, due to biological implausibility.