Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Blood test, Hepatic failure, Inappropriate schedule of product administration, Peripheral swelling
Clinical narrative: Arthritis/Arthritis sensitive to barometric changes; Swollen hands; Kidney and liver are shutting down; Kidney and liver are shutting down; 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; This is a solicited report from non-Pfizer sponsored program, Facilitated Collect received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program, the patient. based on information received by Pfizer from 21K-163-4134820-00.  A 41 year-old male patient received bnt162b2 (Pfizer BioNTech covid-19 vaccine (Tozinameran), Formulation: Solution for injection), intramuscular, administration date 15Apr2021 (Batch/Lot number: unknown) at the age of 40 years as dose 2, single for covid-19 immunisation; glucosamine, indometacin (INDOMETHACIN [GLUCOSAMINE;INDOMETACIN]), intramuscular (Batch/Lot number: unknown) for arthritis; adalimumab (HUMIRA), intramuscular (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose, Route of Admin: Intramuscular, Verbatim: swollen hands), administration date: 01Mar2021, when the patient was 40 years old, for Covid-19 Immunization, reaction(s): "swollen hands", "kidney and liver are shutting down", "kidney and liver are shutting down", "arthritis sensitive to barometric changes". The following information was reported: RENAL FAILURE (medically significant), HEPATIC FAILURE (medically significant) all with onset 2021, outcome "recovering" and all described as "Kidney and liver are shutting down"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 2021, outcome "unknown", described as "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"; ARTHRITIS (non-serious), outcome "unknown", described as "Arthritis/Arthritis sensitive to barometric changes"; PERIPHERAL SWELLING (non-serious), outcome "recovering", described as "Swollen hands". The patient underwent the following laboratory tests and procedures: blood test: (2021) unknown. The action taken for glucosamine, indomethacin and adalimumab was unknown. Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event(s) of kidney and liver are shutting down unknown onset, kidney and liver are shutting down unknown onset and swollen hands with Humira (ADALIMUMAB) was a reasonable possibility. Causality for bnt162b2 (Pfizer BioNTech covid-19 vaccine (Tozinameran),: Causality as per Mfr for the event(s) of Acute kidney injury, Hepatic failure as Not assessable. Causality as per Mfr for the event(s) Lethargy, Malaise, Arthritis, Peripheral swelling, Headache and Vomiting as No reasonable possibility. The reporter's causality for the event(s) of lethargic, ill, arthritis sensitive to barometric changes, headaches and vomiting was not provided. AbbVie'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. Regulatory Authority 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). Solicited report from the Regulatory Authority by a consumer of a 40 year old male with events of renal failure and liver failure and non-serious ill, lethargic, arthritis sensitive to barometric changes, headaches, vomiting and swollen hands with HUMIRA (ADALIMUMAB). There was no reported medical history. On unknown dates, the patient experienced arthritis sensitive to barometric changes and swollen hands. In 2021, the patient experienced renal failure, liver failure, ill, lethargic, headaches and vomiting. Pfizer BioNTech covid-19 vaccine (Tozinameran) and Indomethacin (Glucosamine; Indometacin) were also considered suspect. The patient was taking Indomethacin for arthritis. In 2021, he got blood work back and his kidney and liver were shutting down but then it was stabilized. Indomethacin was one of the medication that was causing his renal and liver failure. His arthritis sensitive to barometric changes. He had swollen hands which he soaked in hot water baths to help relieve. He took third covid shot and felt headaches, lethargic, by night he was ill and had vomiting. No information provided regarding other medications that was causing the side effects. He did not wanted to provide further information and did not agreed to have physician contacted. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 01Mar2021, he received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 15Apr2021, he received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. In 2021, he received 3rd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. The reporter's causality for the events of kidney and liver are shutting down, of ill, lethargic, arthritis sensitive to barometric changes, headaches, vomiting and swollen hands with Pfizer BioNTech Covid-19 Vaccine (TOZINAMERAN) was not reported. Since no determination has been received, the case is managed based on the company causality assessment. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of renal failure and liver failure with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of ill, lethargic, arthritis sensitive to barometric changes, headaches and vomiting was not provided. The reporter's causality for the event(s) of swollen hands with Humira (Adalimumab) was a reasonable possibility.  Regulatory Authority opinion is that the events of renal failure and liver failure are not assessable. Regulatory Authority opinion is that there is no reasonable possibility that the events of ill, lethargic, arthritis sensitive to barometric changes, headaches, vomiting and swollen hands are related to Humira (Adalimumab). Relevant Laboratory & Other Diagnostic Tests: 2021 Blood Work: Indomethacin related renal and kidney failure.  Change History: On 08Dec2021, received updates to patient demographics, event information, reporter opinion of causality, suspect drug information, concomitant drug information, laboratory/diagnostic procedures and narrative description. The event of "Kidney and Liver are Shutting Down" was amended to "renal failure". The event of "kidney and liver are shutting down" was amended to "liver failure. The reporter's assessment of the causal relationship of the events kidney and liver are shutting down, with the suspect product INDOMETHACIN(GLUCOSAMINE;INDOMETACIN) was not related. The reporter's causality for the events of ill, lethargic, arthritis sensitive to barometric changes, headaches, vomiting with INDOMETHACIN(GLUCOSAMINE;INDOMETACIN) was not reported. and swollen hands 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 information currently available,The causal association between the reported events and suspected vaccine 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.