Age: 58.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Fall, Illness, Immunisation reaction, Joint noise
Clinical narrative: COVID SYMPTOMS; COVID SYMPTOMS; Meniscus tear; Vaccination related malaise; Fall; Sinus infection; felt sick after each Covid Vaccine; psoriasis; Joint noise; 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): 22K-163-4298801-00.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 01Aug2021 as dose 1, single (Batch/Lot number: unknown), on 29Aug2021 as dose 2, single (Batch/Lot number: unknown) and on 10Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), as unk, single (Batch/Lot number: unknown) subcutaneous for psoriatic arthropathy. The patient's relevant medical history included: "arthritis" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: JOINT NOISE (non-serious) with onset 2022, outcome "recovered"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "COVID SYMPTOMS"; MENISCUS INJURY (medically significant), outcome "not recovered", described as "Meniscus tear"; VACCINATION COMPLICATION (non-serious), outcome "recovered", described as "Vaccination related malaise"; FALL (non-serious), outcome "not recovered"; SINUSITIS (non-serious), outcome "recovering", described as "Sinus infection"; ILLNESS (non-serious), outcome "recovered", described as "felt sick after each Covid Vaccine"; PSORIASIS (non-serious), outcome "unknown". The action taken for adalimumab was unknown.  Clinical Course: On unknown dates, torn meniscus, covid symptoms after each one/ felt sick after each covid vaccine, fell on knee/ heard a popping sound and cold which turned into a sinus infection. In 2022, the patient experienced fell on knee/ heard a popping sound. Patient stated that she had a torn meniscus and had knee surgery on 23Mar2022. She stated that the doctor told her that her arthritis might have played a major part in this. On an unknown date, covid symptoms after each one/felt sick after each covid vaccine resolved. She kept getting sinus infections and she was off from Humira for knee surgery. Her doctor took her off of Humira. She also stated that the Humira was not clearing up her psoriasis. The event of "Torn Meniscus" is now considered serious. It was unknown if patient was enrolled in a COVID-19 vaccine trial.   Causality for Humira (Adalimumab): The reporter's causality for event Vaccination related malaise was No reasonable possibility. The reporter's causality for all the other event(s) with humira (Adalimumab) were not reported. As per agency, causality of all the event(s) with humira (Adalimumab) were No reasonable possibility.  Causality for PFIZER BIONTECH COVID-19 VACCINE: The reporter's causality for event Vaccination related malaise was reported as possible and for other events causality were not reported.  The reporter's assessment of the causal relationship of the event 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.  Follow-up attempts completed. No further information is expected.  Follow-up (08Apr2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  Follow-up (11Apr2022): This is a follow-up Solicited report based on information received by Pfizer (Manufacturer Control Number: 22K-163-4298801-00). A contactable consumer (patient) reported updated information included new event Psoriasis, event information, reporter opinion of causality, company alternative etiology, suspect drug information and RMH added.  Follow-up attempts completed. No further information is expected.; Sender's Comments: Based on the information provided there is a reasonable possibility of causal association between the events with the suspect product bnt162b2.