Sex: F
Vaccine: COVID19, UNK
Symptoms: Gait disturbance, Illness, Knee arthroplasty, Musculoskeletal disorder, Procedural pain
Clinical narrative: allergic reaction episode from covid vaccine; Dizziness; Fever; not able to walk very well; knee replacement and was still in pain; knee replacement and was still in pain; sick; limited control of hands/not able to use hands very well; RA pain; Swelling; sars-cov-2 test: (10Dec2020) positive; COVID-19; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-3926170-00 (Agency).  A 67 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1154341) at cf for rheumatoid arthritis. Relevant medical history included: "Covid-19", start date: 10Dec2020, stop date: 10Dec2020, notes: Recovered/Resolved. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "sars-cov-2 test: (10Dec2020) positive"; COVID-19 (medically significant), outcome "unknown", described as "COVID-19"; DRUG HYPERSENSITIVITY (hospitalization), outcome "recovered", described as "allergic reaction episode from covid vaccine"; DIZZINESS (hospitalization), outcome "recovered", described as "Dizziness"; PYREXIA (hospitalization), outcome "recovered", described as "Fever"; ILLNESS (hospitalization) with onset 2020, outcome "unknown", described as "sick"; KNEE ARTHROPLASTY (hospitalization) with onset 15Dec2021, outcome "recovering", GAIT DISTURBANCE (hospitalization), outcome "not recovered" and all described as "not able to walk very well"; PROCEDURAL PAIN (hospitalization), outcome "not recovered", described as "knee replacement and was still in pain"; MUSCULOSKELETAL DISORDER (non-serious), outcome "recovering", described as "limited control of hands/not able to use hands very well"; ARTHRALGIA (non-serious), outcome "not recovered", described as "RA pain"; SWELLING (non-serious), outcome "not recovered", described as "Swelling".  The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Dec2020) positive.Clinical comment: It was unknown if she was enrolled in a COVID-19 vaccine trial.   Causality for PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN), UNKNOWN) The reporter's causality for the event(s) of COVID-19 with PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN), UNKNOWN was possible for the events Allergic reaction to drug, Dizziness and not reported for the events Sickness, Knee replacement, Fever, Upper extremity dysfunction, Difficulty in walking, Swelling,COVID-19,Arthritic pains and Post procedural pain.  Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the events Allergic reaction to drug, Dizziness, Fever, Upper extremity dysfunction,Difficulty in walking and COVID-19  were no reasonable possibility and not reported for all other events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The reported COVID-19 positive after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2.  Based on the current available limited information in the case provided, the causal association between the events Drug hypersensitivity, Dizziness, Pyrexia, Illness, Knee arthroplasty, Gait disturbance, Musculoskeletal disorder, Arthralgia, Swelling and the use of suspect product BNT162B2 cannot be fully excluded. Procedural pain is assessed unrelated as it is as it is due to knee replacement.   The case will be reassessed once further information is available  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 RAs, Ethics Committees, and Investigators, as appropriate.