Sex: M
Vaccine: COVID19, UNK
Symptoms: Lethargy, Malaise, Peripheral swelling, Vomiting
Clinical narrative: Kidney and liver are shutting down; Kidney and liver are shutting down; Lethargic; Ill feeling; Arthritis; Swollen hands; Headaches; Vomiting; This is a solicited report from non-Pfizer sponsored program, received from a contactable consumer, the patient, based on information received by Pfizer from facilitating company (21K-163-4134820-00).   A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 01Mar2021 (Batch/Lot number was not reported) as dose 1, single; intramuscular on 15Apr2021 (Batch/Lot number was not reported) as dose 2, single; intramuscular on an unspecified date in 2021 (Batch/Lot number was not reported) as dose 3 (booster), single for COVID-19 vaccination; and adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose and frequency (reported as "CF") for Moderate to severe Rheumatoid Arthritis. Medical history included arthritis. Concomitant medication included indometacin sodium (INDOMETHACIN) for arthritis. The patient experienced kidney and liver are shutting down, lethargic, ill feeling, arthritis, swollen hands, headaches, and vomiting on an unspecified date. It was reported that on an unspecified date, the patient experienced kidney and liver are shutting down, lethargic, ill, arthritis sensitive to barometric changes, swollen hands, headaches and vomiting. The patient took indomethacin for arthritis. He got blood work on an unspecified date in 2021 back and his kidney and liver were shutting down but it's stabilized, arthritis sensitive to barometric changes. He had swollen hands soaked in hot water baths for relief. He took third covid shot had headaches, lethargic, ill and vomiting. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 01Mar2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer and BioNTech. On 15Apr2021, patient received 2nd dose COVID-19  Vaccine manufactured by Pfizer and BioNTech. On unknown date in 2021, patient received 3rd dose COVID-19 Vaccine manufactured by Pfizer and BioNTech. The action taken in response to the events for adalimumab was unknown. The outcome of the events acute kidney injury and hepatic failure and hand swelling was recovering while the outcome of the rest of the events was unknown.   Facilitating Company's opinion is that the events of kidney and liver are shutting down unknown onset and kidney and liver are shutting down unknown onset are not assessable. Facilitating Company's opinion is that there is no reasonable possibility that the events of lethargic, ill, arthritis sensitive to barometric changes, swollen hands, headaches and vomiting are related to humira(adalimumab).   The reporter's causality for the events of kidney and liver are shutting down and swollen hands with humira (adalimumab) was a reasonable possibility. The reporter's causality for the events of lethargic, ill, arthritis sensitive to barometric changes, headaches and vomiting with humira (adalimumab) was not provided.   The reporter's assessment of the causal relationship of the event with the suspect product 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events kidney and liver are shutting down cannot be totally 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.