Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Investigation, Liver disorder, Oropharyngeal pain, Swelling, Tongue disorder
Clinical narrative: Diabetic; Hepatic disease; Tiredness; Sores lip; taste buds inflamed like they were burnt/bumps on the tongue/taste buds; Inflammation tongue; Neck swelling; Chills; Sore throat; This is a solicited report from a marketing program facilitated collect received from a consumer (patient) by Pfizer from AbbVie, Manufacturer control number: 21K-163-3984947-00.  A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular in Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 intramuscular in Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation; upadacitinib (RINVOQ), oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unknown dose for rheumatoid arthritis. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced diabetic. In 2021, the patient experienced sore on lip, taste buds inflamed like they were burnt/bumps on the tongue/taste buds, inflammation tongue, neck swelled, chills, felt tired, (tiredness) and sore throat. In Aug2021, the patient experienced liver disease. In 2021, the neck swelled resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. The patient had reaction to both covid vaccines. She had sore throat, chills, taste buds inflamed like they were burnt and a sore on her lip which came and gone. She had her neck swelled for 13 days on first shot. Second dosage caused her neck swelled again for over three months and had bumps on the tongue (taste buds). She did not want to get the booster. She was diagnosed with liver disease in Aug2021 and healthcare professional put her on strict diet (Mediterranean diet). She was feeling tired and healthcare professional advised it might be due to having liver disease. She was a diabetic. Her lab work came back good with RINVOQ. It was unknown if patient was enrolled in a covid-19 vaccine trial. The action taken for upadacitinib was unknown. The outcome of sores lip, inflammation tongue, chills and sore throat were recovering, outcome of neck swelling was recovered in 2021, outcome of other events was unknown.  Causality for RINVOQ (UPADACITINIB): The reporter's causality for the events of sore on lip, inflammation tongue, chills, sore throat was no reasonable possibility. The reporter's causality for the events of bumps tongue, hepatic disease, diabetic, neck swelling, tiredness was not provided. Causality for PFIZER BIONTECH COVID-19 vaccine: The reporter's causality for the events of sores lip, bumps tongue, inflammation tongue, neck swelling, chills, sore throat was possible. The reporter's causality for the events of hepatic disease, diabetic, tiredness was not reported.  The reporter's assessment of the causal relationship of the events of hepatic disease, diabetic and tiredness with the suspect 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 reasonable possibility of causal association between the events  sores lip, bumps tongue, inflammation tongue, neck swelling, chills, sore throat hepatic disease, diabetic, tiredness 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.