Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia, Polymyalgia rheumatica, Rebound eczema
Clinical narrative: he got stiff and sore muscles which continued to get worse; Eczema came back/rebound eczema; polymyalgia rheumatica; he got stiff and sore muscles which continued to get worse; This is a solicited report based on the information received by Pfizer. (Mfr Report Number: 2020SA132456). A contactable 68-year-old male consumer (patient) reported for himself that:  Initial information received on 19May2020 and live follow up was received on the same date regarding a solicited valid serious case received from a patient via nurse, in the scope of patient support program "withheld. This case involves 68 years old male patient who had polymyalgia rheumatica, he got stiff and sore muscles which continued to get worse, eczema came back and swelling in his groin area, above the genital on then left and right side but more pronounced on the right side; swollen, puffy lymph node while being treated with dupilumab (Dupixent) with the use of medical device dupilumab pre-filled syringe and tozinameran (Pfizer Biontech COVID-19 vaccine). The patients past medical history, medical treatment and family history were not provided. Concomitant medication: prednisone. On 08Jan2020, the patient started taking dupilumab injection of unknown strength at a loading dose of 600 mg once subcutaneously (lot number and expiry date: unknown) followed by 300 mg every other week subcutaneously since an unknown date in Jan2020 (lot-9L765A, expiry date: 31Oct2022) via dupilumab prefilled syringe for atopic dermatitis unspecified and eczema. First time used product: no. Information on batch number was requested. On an unknown date, the patient received 1st dose of tozinameran (strength, therapy details, lot details: unknown) for COVID-19 vaccination. On 16May2020 (Latency: 4 months 8 days), the patient experienced sweating in his groin area, above the genital on then left and right side but more pronounced on the right side, there was an egg sized hard lump (swelling) (mass). Reportedly, he developed swollen, puffy, partially hardened right groin lymph node, He tried to reach Dermatologists but was unsuccessful and now will try to reach the primary care physician to report for the event. This morning (19May2020), lump had gone down some. He added that during his last injection, he did not inject into his abdomen, but more into his lateral side and asked if that could cause the issues with the groin. He was referred to healthcare professional. After receiving the first dose of tozinameran, he had muscle ache, he went ahead got the 2nd dose of the vaccine and he was diagnosed of Polymyalgia Rheumatica (onset date: 2021 and latency: few months from receiving dupilumab and unknown from receiving tozinameran; it was a medically significant event). He was off on prednisone and his eczema came back (rebound eczema; onset date: 2021 and latency: few months from receiving dupilumab and unknown from receiving tozinameran). He stopped taking dupilumab and the doctor was not aware. He would follow up with his internal medicine physician and dermatologist to get back starting on dupilumab. Patient stopped taking dupilumab in Mar2021, before he took the Pfizer covid vaccine he called and asked if he could skip a dose of DUPIXENT or if he should avoid the Covid vaccine while on dupilumab, everyone said no, no problem so he took his dupilumab Injection then the next day he took the Pfizer covid vaccine, 5 to 7 days later he got stiff (Musculoskeletal stiffness) (condition aggravated) (onset: 2021; latency: unknown) and sore muscles which continued to get worse; he was still taking dupilumab when he took his second covid vaccine; it get got much worse and he was diagnosed with PMR, polymyalgia rheumatica; his doctor said to change some medication so he elected to go off dupilumab in Mar-2021. He does not know if him having PMR was related to dupilumab or just his bad luck, he had been on Prednisone for 5 months; Prednisone also controlled his eczema; he was now off Prednisone and hopefully cured of PMR, he will have a sed test next week to find out; his eczema was back so he could go back on Prednisone, but he was thinking about starting up dupilumab. Action taken: No action taken for swelling mass and drug withdrawn in Mar2021 for the rest for dupilumab and unknown for all events for tozinameran. Corrective treatment. Not reported. Outcome was recovering from mass, Musculoskeletal stiffness, Polymyalgia Rheumatica and not resolved for the rest. Reporter causality: un assessable for Musculoskeletal stiffness, Polymyalgia Rheumatica; Not reported for other. Company causality: Not reportable for swelling and mass and reportable for the rest. Additional information was received on 28Sep2021 from the patient via the patient support program call center through Lash: Case upgraded to serious due to the addition of the serious event of polymyalgia rheumatica. Other event of eczema added. Suspect product tozinameran added. Additional information was received on 27Sep2021 from patient via call center through Lash: event: Musculoskeletal stiffness added; verbatim of myalgia updated; reporter causality updated for Polymyalgia Rheumatica.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the events and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.