Age: 54.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Benign lymph node neoplasm, Body temperature, Computerised tomogram, Pyrexia, Thyroid neoplasm
Clinical narrative: Thyroid tumor; Benign neoplasm of lymph nodes; He also was sick with a fever of 101 for two days after he got his Covid vaccination.; MARKETING PROGRAM NAME NOT APPLICABLE  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-163-4402330-00 (Agency).  A 54-year-old male patient received BNT162b2 (BNT162B2), on 12Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 54 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Lot number: 1159933) at daily (citrate free), subcutaneous for psoriatic arthropathy, psoriasis. The patient's relevant medical history included: "patient had mild covid", start date: Oct2021 (unspecified if ongoing), notes: Oct2021, pt had mild covid.; "interchange of vaccine products", start date: 12Dec2021 (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: janssen covid-19 vaccine (Daily Dose: First Dose (1 in 1 Once), Route of Admin: Intramuscular), administration date: 20Mar2021, when the patient was 53-year-old, for COVID-19 Immunization. The following information was reported: THYROID NEOPLASM (medically significant), outcome "unknown", described as "Thyroid tumor"; BENIGN LYMPH NODE NEOPLASM (medically significant), outcome "unknown", described as "Benign neoplasm of lymph nodes"; PYREXIA (non-serious), outcome "recovered", described as "He also was sick with a fever of 101 for two days after he got his Covid vaccination.". The patient underwent the following laboratory tests and procedures: Body temperature: 101; Computerised tomogram: tumors in his thyroid and both lymph nodes, notes: He had Computed tomography scan done which showed tumors in his thyroid and both lymph nodes. The action taken for adalimumab was unknown. Clinical course: On unknown dates, the patient experienced tumors in thyroid, tumors in both lymph nodes and sick with fever. In Oct2021, the patient experienced Covid. On unknown dates, Covid and sick with fever resolved. Pfizer Biontech Covid-19 Vaccine (Tozinameran) was also considered suspect. In Oct2021, patient had mild covid. He also was sick with a fever of 101 for two days after he got his Covid vaccination. Patient's physician had cut one of his medications from 100 milligram to 50 milligram. He had Computed tomography scan done which showed tumors in his thyroid and both lymph nodes for which surgery was performed to remove 14 polyps and out of 14, eight were cancerous. Patient had discontinued an NSAID to before surgery. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.    The reporter's causality for the event(s) of tumors in thyroid and tumors in both lymph nodes was Not Reported and Causality as per reporter for event pyrexia was Possible with 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: As there is limited information in the case provided, the causal association between the events - benign lymph node neoplasm, thyroid neoplasm and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   Based on available information and known drug safety profile, the causality between the event pyrexia and the suspect drug BNT162B2 cannot be completely 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.