Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Interchange of vaccine products, Joint arthroplasty, Limb discomfort, Musculoskeletal stiffness, Off label use
Clinical narrative: right knee replaced; arm felt heavy and stiff; arm felt heavy and stiff; COVID-19 Vaccine manufactured by Moderna/ COVID-19 Vaccine manufactured by Pfizer/BioNTech.; COVID-19 Vaccine manufactured by Moderna/ COVID-19 Vaccine manufactured by Pfizer/BioNTech.; 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-163-4130777-00.  A 65 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Apr2021 (Batch/Lot number: unknown) at the age of 64 years as dose 1, single and intramuscular, administration date 22Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), intramuscular (Batch/Lot number: unknown) as dose 2 (booster), single and intramuscular (Batch/Lot number: unknown) as dose 1 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous (Lot number: 1152121) and second regimen subcutaneous (Lot number: 1154443) for rheumatoid arthritis. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 01Apr2021, outcome "unknown" and all described as "COVID-19 Vaccine manufactured by Moderna/ COVID-19 Vaccine manufactured by Pfizer/BioNTech."; JOINT ARTHROPLASTY (medically significant), outcome "recovering", described as "right knee replaced"; MUSCULOSKELETAL STIFFNESS (medically significant), LIMB DISCOMFORT (medically significant), outcome "recovered" and all described as "arm felt heavy and stiff". The action taken for adalimumab was temporarily withdrawn. Therapeutic measures were taken as a result of joint arthroplasty.  Causality for Humira (Adalimumab) the reporter's causality for the event(s) of right knee replaced, arm felt heavy and stiff unknown onset, arm felt heavy and stiff unknown onset, fatigue and mild headache was not provided. Manufacturer opinion is that there is no reasonable possibility that the events of right knee replaced, arm felt heavy and stiff unknown onset, arm felt heavy and stiff unknown onset, fatigue and mild headache are related to Humira (Adalimumab). The Causality as per reporter (Drug/Vaccine) was not reported, action(s) taken with drug was unknown and Dechallenge was N/A for COVID-19 VACCINE MODERNA. The Causality as per reporter (Drug/Vaccine) for the events total knee replacement, heaviness in arm and limbs stiffness was not reported; action(s) taken with drug was unknown and Dechallenge was N/A for PFIZER BIONTECH COVID-19 VACCINE.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal association, the causal association between the events Off label use, interchange of vaccine, joint arthroplasty, Musculoskeletal stiffness and limb discomfort and the suspect drug BNT162B2 cannot be excluded  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