Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis, Thyroid mass, Ultrasound thyroid
Clinical narrative: 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-163-4409204-00. A 62-year-old female patient received BNT162b2 (BNT162B2), on 15Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Batch/Lot number: unknown) at citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history included: "thyroid showed mass/mass in throat and enlarged lymph node", start date: 2019 (unspecified if ongoing), notes: In 2019, the patient experienced thyroid showed mass/mass in throat and enlarged lymph node.; "enlarged lymph node", start date: 2019 (unspecified if ongoing), notes: In 2019, the patient experienced thyroid showed mass/mass in throat and enlarged lymph node. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose:2, Date: 15Apr2021, Route: Intramuscular), administration date: 15Apr2021, when the patient was 61-year-old, for COVID-19 Immunization; BNT162b2 (Dose:1, Date: 15Mar2021, Route: Intramuscular), administration date: 15Mar2021, when the patient was 61-year-old, for COVID-19 Immunization. The following information was reported: THYROID MASS (non-serious) with onset 2022, outcome "not recovered", described as "the patient experienced thyroid showed mass and several nodules in throat/thyroid mass."; RHEUMATOID ARTHRITIS (medically significant), outcome "recovering", described as "Rheumatoid arthritis flare up". The patient underwent the following laboratory tests and procedures: Ultrasound thyroid: (2019) Masses, several nodules and enlarged lymph node; (2022) Mass on thyroid. The action taken for adalimumab was dosage not changed. Clinical course included: On 27Jun2022, received updates to event information and narrative description. The event of "ultrasound on thyroid showed mass" was amended to " thyroid showed mass/mass in throat ". The event of "ultrasound on thyroid showed mass and several nodules, enlarged lymph node" was amended to " thyroid showed mass and several nodules in throat/thyroid mass ". The event of "ultrasound on thyroid showed mass and several nodules, enlarged lymph node was amended to "enlarged lymph node". On 31Aug2022, received updates to event information, reporter opinion of causality, suspect drug information and narrative description. The event of "rheumatoid arthritis flare up " was added. The reporter considered "rheumatoid arthritis flare up" related to BNT162b2. The reporter's assessment of the causal relationship of "the patient experienced thyroid showed mass and several nodules in throat/thyroid mass" 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. Causality: For Humira, the reporter's causality for the event(s) of thyroid mass and rheumatoid arthritis flare up was not provided. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: As there is limited information in the case provided, the causal association between the events Rheumatoid arthritis and thyroid mass with the suspect product BNT162b2 cannot be excluded. The case will be reassessed once new information is available. 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.