Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Axillary mass, Drug ineffective, Fatigue, Musculoskeletal stiffness
Clinical narrative: feet neuropathy; more hand stiffness; trigger finger on the right hand; swelling in the armpit with the last two doses of booster vaccine; asymptomatic covid; asymptomatic covid; fatigue; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4431030-00.  A 50-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), from 03Dec2021 (Batch/Lot number: unknown) to 2022 at 40 mg, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization; Bnt162b2 (Dose: 03, Route of Administration: Intra-muscular), administration date: Dec2021, when the patient was 49 years old, for COVID-19 immunization, reaction(s): "Asymptomatic COVID-19", "Fatigue", "Limbs stiffness", "Peripheral neuropathy", "Local swelling", "Trigger finger". The following information was reported: DRUG INEFFECTIVE (medically significant), ASYMPTOMATIC COVID-19 (medically significant) all with onset 09Jun2022, outcome "unknown" and all described as "asymptomatic covid"; FATIGUE (non-serious) with onset Jun2022, outcome "not recovered"; NEUROPATHY PERIPHERAL (medically significant), outcome "not recovered", described as "feet neuropathy"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "not recovered", described as "more hand stiffness"; TRIGGER FINGER (non-serious), outcome "unknown", described as "trigger finger on the right hand"; AXILLARY MASS (non-serious), outcome "not recovered", described as "swelling in the armpit with the last two doses of booster vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jun2022) Positive. The action taken for adalimumab was dosage permanently withdrawn in 2022.  Additional information: Solicited report by a consumer of a 50 year old female with events of non-serious Fatigue, More Hand Stiffness, Trigger Finger on the Right Hand, Swelling in the Armpit with the Last Two Doses of Booster Vaccine, Feet Neuropathy and Asymptomatic Covid with Humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced More Hand Stiffness, Trigger Finger on the right hand, Axillary Mass and Feet Neuropathy. In Jun2022, the patient experienced Fatigue. On 09Jun2022, the patient experienced Asymptomatic Covid. Pfizer Biontech Covid-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.    Causality for Humira (Adalimumab): The reporter's causality for the event(s) of Fatigue, More Hand Stiffness, Trigger Finger On The Right Hand, Axillary mass, Feet Neuropathy and Asymptomatic Covid was not provided. Change History was, On 23Jun2022, received updates to event information, reporter opinion of causality, suspect drug information, concomitant drug information and narrative description. The events of "More Hand Stiffness", "Trigger Finger On The Right Hand", " Axillary Mass" and "Feet Neuropathy" were added. The event of "Positive For Covid" was amended to "Asymptomatic Covid". Causality for BNT162B2: The reporter's causality for the events of Fatigue, More Hand Stiffness, Trigger Finger On The Right Hand, Axillary mass, Feet Neuropathy and Asymptomatic Covid was not reported. The reporter's assessment of the causal relationship of "asymptomatic covid", "feet neuropathy", "fatigue", "more hand stiffness", "trigger finger on the right hand" and "swelling in the armpit with the last two doses of booster vaccine" 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 information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer drug 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.