Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Calculus bladder, Chills, Fatigue, Malaise, Pain
Clinical narrative: Stone urinary bladder; Fever; Pain in arm; Ache; Vaccination site pain; Vaccination related malaise; Fatigue; Chills; Did not feel well; This is a solicited report received from a contactable consumer (patient) based on the information received by Pfizer from Regulatory Authority (Manufacturer Control No: 21K-163-3816612-00).   A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 20Feb2021 (Batch/Lot number was not reported), dose 2 intramuscular on 30Mar2021 (Batch/Lot number was not reported) both as a single dose for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at a single dose for an unspecified indication; adalimumab (HUMIRA, solution for injection in pre-filled pen), subcutaneous from an unspecified date (Batch/Lot number was not reported) and ongoing, at unknown dosage (Citrate Free) for Moderate to severe adult crohn's disease. Medical history included the patient had Surgery for bladder stone removal in 2020. The patient's concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient experienced stone urinary bladder (medically significant) on an unspecified date, fever, pain in arm, ache, vaccination site pain, vaccination related malaise, fatigue, chills, did not feel well in 2021. Solicited report from the RA by a consumer of a 65-year-old male with events of bladder stone and non-serious covid-19 vaccine reaction/fatigue/arm hurt and did not feel well, arm was sore after getting flu shot, chills, fever and achy with Humira (Adalimumab). On unknown dates, the patient experienced bladder stone and arm was sore after getting flu shot. In 2021, the patient experienced covid-19 vaccine reaction/fatigue/arm hurt and did not feel well, chills, fever and achy. On an unknown date, bladder stone resolved. Pfizer BioNTech covid-19 vaccine (Tozinameran) and Influenza (influenza vaccine) were also considered suspect. The patient had surgery for bladder stone removal in 2020. He had reaction with covid-19 vaccine. His arms hurt, had fatigue, did not feel well, had fever, achy and chills. The arm was sore after getting flu shot. The causality for the surgery was reported as no reasonable possibility. This report reported as serious: Other Medically Important Condition. The action taken in response to the events for adalimumab was dose not changed. The outcome of the event "Stone urinary bladder" was recovered. The outcome of other events was unknown.  The reporter's assessment of the causal relationship of the events "Stone urinary bladder" and "Feeling unwell" with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case was managed based on the company causality assessment.  Causality for BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE): The reporter's causality for event "Stone urinary bladder" was not reported, causality for events "Vaccination related malaise, Fatigue, Vaccination site pain, Chills, Pain in arm, Fever, Ache (Pain)" was possible.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of bladder stone was not provided. The reporter's causality for the event(s) of covid-19 vaccine reaction/fatigue/arm hurt and did not feel well onset in 2021, covid-19 vaccine reaction/fatigue/arm hurt and did not feel well onset in 2021, arm was sore after getting flu shot, chills, covid-19 vaccine reaction/fatigue/arm hurt and did not feel well onset in 2021, covid-19 vaccine reaction/fatigue/arm hurt and did not feel well onset in 2021, fever and achy with Humira (Adalimumab) was no reasonable possibility.   Regulatory Authority opinion is that there is no reasonable possibility that the events of bladder stone, covid-19 vaccine reaction/fatigue/arm hurt and did not feel well onset in 2021, covid-19 vaccine reaction/fatigue/arm hurt and did not feel well onset in 2021, arm was sore after getting flu shot, chills, covid-19 vaccine reaction/fatigue/arm hurt and did not feel well onset in 2021, covid-19 vaccine reaction/fatigue/arm hurt and did not feel well onset in 2021, fever and achy are related to Humira (Adalimumab).   No follow-up attempts are possible: information about lot/batch number cannot be obtained.; Sender's Comments: Based on the limited information in the case, a contributory effect of the vaccine BNT162B2 to the reported events cannot be ruled out. 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.