Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Myalgia, Peripheral swelling
Clinical narrative: some swelling in her legs and feet/Swelling in the legs below knee; muscle pain; joint pain; This is a spontaneous report received from contactable reporter(s) (Physician).  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation; dupilumab (DUPIXENT), (Batch/Lot number: unknown) at 300 mg, subcutaneous for asthma. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ELIDEL; PREDNISONE taken for asthma; EUCRISA; PULMICORT; FLONASE [FLUTICASONE PROPIONATE]; TRIAMCINOLONE ACETONIDE; PROVENTIL [SALBUTAMOL]. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization.  The following information was reported: ARTHRALGIA (non-serious) with onset 10Oct2022, outcome "unknown", described as "joint pain"; MYALGIA (non-serious) with onset 10Oct2022, outcome "unknown", described as "muscle pain"; PERIPHERAL SWELLING (non-serious) with onset 10Oct2022, outcome "recovered" (11Oct2022), described as "some swelling in her legs and feet/Swelling in the legs below knee". The action taken for dupilumab was unknown. Therapeutic measures were not taken as a result of peripheral swelling.  Additional information: This case involved a 69 year old female patient who had some swelling in her legs below knee, muscle pain and joint pain, while being treated with dupilumab (Dupixent) via dupilumab pre-filled syringe and Tozinameran (Pfizer BioNtech COVID-19 vaccine). The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant medications included pimecrolimus (Elidel); Prednisone(Prednisone); Crisaborole(Eucrisa); Budesonide(Pulmicort); Fluticasone Propionate (Flonase Fluticasone propionate); Triamcinolone acetonide (Triamcinolone acetonide); Salbutamol (Proventil (salbutamol); and Prednisone(Prednisone) for asthma. On an unknown date, the patient started taking Dupixent (dupilumab) Solution for injection strength: 300mg/2ml at a dose of 300 mg, freguency: other via subcutaneous route (with an unknown batch number, expiry date) for Asthma delivered pre-filled syringe. Information. On 10Oct2022 the patient developed a non-serious event "some swelling in her legs and feet/swelling in the legs below knee" (peripheral swelling) unknown latency following the first dose intake of Dupilumab and 10 days following the first dose intake of Tozinameran. On 10Oct2022 the patient developed a non-serious event "muscle pain" (myalgia) unknown latency following the first dose intake of Dupilumab and 10 days following the first dose intake of Tozinameran. On 10Oct2022 the patient developed a non-serious event "joint pain" (arthralgia) unknown latency following the first dose intake of Dupilumab and 10 days following the first dose intake of Tozinameran. It was reported "Reporter stated that: Spoke with patient she felt the by swell with due to covid booster she received 2 weeks before, she has taken her Dupixent has had no swelling Reaction: Swelling in the legs below knee outcome: 2 days-went away without no treatment. It is unknown if there were lab data/results available." Action taken with Dupilumab (Dupixent) and Tozinameran (Pfizer BioNtech COVID-19 vaccine) was unknown for all events. It was not reported if patient received a corrective treatment for all the reported events. At time of reporting, the outcome was unknown for all the reported events except recovered/resolved for the event Peripheral swelling.  No follow-up attempts are Needed. Information on Lot/Batch number cannot be obtained. No further information is expected.