Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Dyspnoea, Headache, Oropharyngeal pain
Clinical narrative: pain localized to left knee; Respiratory difficulty; Sore throat; pain localized to her left arm; pain localized to her left arm and left knee/specifically to arm where vaccine was administered; Headache; Stomachache; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2), on 16Apr2021 as dose 1, single (Batch/Lot number: unknown) intramuscular, in left arm for covid-19 immunisation; adalimumab (HUMIRA), since 08Jan2020 (ongoing) (Batch/Lot number: unknown) at 0.4 mL, subcutaneous for rheumatoid arthritis. The patient's relevant medical history included: "Right knee replacement", start date: 2018 (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Apr2021, outcome "recovered"; DYSPNOEA (non-serious) with onset Apr2021, outcome "recovered", described as "Respiratory difficulty"; OROPHARYNGEAL PAIN (non-serious) with onset Apr2021, outcome "recovered", described as "Sore throat"; ABDOMINAL PAIN UPPER (non-serious) with onset Apr2021, outcome "recovered", described as "Stomachache"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "recovered", described as "pain localized to her left arm"; VACCINATION SITE PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "pain localized to her left arm and left knee/specifically to arm where vaccine was administered"; ARTHRALGIA (medically significant) with onset Apr2021, outcome "not recovered", described as "pain localized to left knee". The action taken for adalimumab was dosage not changed. Clinical course: The reporter reported events of KNEE PAIN and non-serious reaction to COVID-19 vaccine, respiratory difficulty, sore throat, pain localized to left arm left knee, headache, stomachache and leg inflammation with HUMIRA 40MG/0.4ML (ADALIMUMAB). In April 2021, the patient experienced reaction to COVID-19 vaccine, respiratory difficulty, sore throat, pain localized to left arm left knee, headache, stomachache. In 2022, the patient experienced knee pain. In July2022, the patient experienced leg inflammation. On unknown dates, respiratory difficulty, sore throat, pain localized to left arm left knee, headache, stomachache was resolved. BNT162B2 (TOZINAMERAN) was also considered suspect. Patient reported that pain localized to her left arm and left knee. She reported events occurred a few days after receiving Covid-19 vaccine in Apr2021, specifically to arm where vaccine was administered. Patient underwent a left knee replacement on 20Jul2022 and was recovering from surgery. Patient is receiving therapies as a treatment The event of knee pain was considered medically significant. Alternative etiology for event leg inflammation was reported as knee surgery. It was unknown if she was enrolled in a COVID-19 Vaccine Trial.  The reporter's assessment of the causal relationship of "respiratory difficulty", "sore throat", "pain localized to her left arm", "pain localized to left knee", "pain localized to her left arm and left knee/specifically to arm where vaccine was administered", "headache" and "stomachache" not related to Humira. The causality as per manufacturer for all the events was no reasonable possibility.  The reporter's assessment of the causal relationship of "pain localized to left knee" with the suspect product(s) BNT162b2 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 reporter considered "respiratory difficulty", "sore throat", "pain localized to her left arm", "pain localized to her left arm and left knee/specifically to arm where vaccine was administered", "headache" and "stomachache" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The events of headache, abdominal pain upper, vaccination site pain, oropharyngeal pain, pain in extremity, dyspnea are assessed as possibly related to the suspect drug BNT162b2 based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications.  The reported event - arthralgia, can be most plausibly explained by underlying condition -  rheumatoid arthritis, thus unrelated to suspect drug BNT162b2 .  The impact of this report on the benefit/risk profile of the Pfizer product 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.,Linked Report(s) : PR-PFIZER INC-PV202200062408 Same patient, same vaccine in different dose, partial same event;