Sex: F
Vaccine: COVID19, UNK
Symptoms: Animal bite, Influenza like illness, Malaise
Clinical narrative: Fingers were mauled by a dog; Ill; Flu-like symptoms;   This is a solicited report received from contactable reporter (consumer) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4170330-00 (company).  A 36 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) intramuscular (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown) for moderate to severe rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANIMAL BITE (medically significant), outcome "recovering", described as "Fingers were mauled by a dog"; MALAISE (medically significant), outcome "recovered", described as "Ill"; INFLUENZA LIKE ILLNESS (medically significant), outcome "recovered", described as "Flu-like symptoms". The action taken for upadacitinib was unknown. Therapeutic measures were taken as a result of animal bite. On unknown dates, the patient experienced fingers were mauled by a dog, ill and flu-like symptoms. On unknown dates, ill and flu-like symptoms resolved. PFIZERBIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. The patient's fingers were mauled by a dog and had to undergo reattachment surgery. She was getting ill and had flu-like symptoms after Pfizer vaccination. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. She received dose of COVID-19 Vaccine manufactured by Pfizer/BioNTech.   Causality for RINVOQ (UPADACITINIB): The reporter's causality for the events of fingers were mauled by a dog, ill and flu-like symptoms with RINVOQ (UPADACITINIB) was no reasonable possibility. Company's opinion is that there is no reasonable possibility that the events of fingers were mauled by a dog, ill and flu-like symptoms are related to RINVOQ (UPADACITINIB).  Causality for PFIZER BIONTECH COVID-19 VACCINE: The reporter's causality for the events of fingers were mauled by a dog, ill and flu-like symptoms with BNT162B2 was not reported.  The reporter's assessment of the causal relationship of the events with the PFIZER BIONTECH COVID-19 VACCINE 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 known drug safety profile, there is no reasonable possibility of causal association between the event Animal bite and BNT162B2.  Based on known drug safety profile, there is reasonable possibility of causal association between the events Malaise and Influenza like illness  and BNT162B2.  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.