Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Bell's palsy, Lethargy, Nausea
Clinical narrative: stomach cramps; Lethargic; Nausea; Bells Palsy on right side of body; This is a report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.   A 49-year-old female patient received BNT162b2 (BNT162B2), on 27Dec2020 as dose 1, single (Batch/Lot number: unknown), on 20Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 20Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years, all intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (ongoing) (Lot number: 1157155), oral for psoriasis, rheumatoid arthritis, colitis ulcerative. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU [INFLUENZA VACCINE], in 2022 as dose number unknown, single. Past drug history included: Bactrim, reaction(s): "Drug hypersensitivity with BACTRIM", notes: Drug hypersensitivity with Bactrim; Morphine, reaction(s): "Drug hypersensitivity with MORPHINE", notes: Drug hypersensitivity with Morphine; Erythromycin, reaction(s): "Drug hypersensitivity with ERTHMYCIN", notes: Drug hypersensitivity with Erthmycin.  The following information was reported: BELL'S PALSY (medically significant) with onset 20Aug2021, outcome "recovered" (20Aug2021), described as "Bells Palsy on right side of body"; LETHARGY (non-serious) with onset 22Sep2022, outcome "recovering", described as "Lethargic"; NAUSEA (non-serious) with onset 22Sep2022, outcome "recovered" (23Sep2022); ABDOMINAL PAIN UPPER (non-serious), outcome "not recovered", described as "stomach cramps". The action taken for upadacitinib was unknown.  The reporter's assessment of the causal relationship of "bells palsy on right side of body", "lethargic", "nausea" and "stomach cramps" with the suspect product(s) 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.  Clinical course: On 23Sep2022, Nausea recovered/resolved. Pfizer/BioNTech covid vaccine was also considered suspect. Patient since starting the Rinvoq she was experiencing stomach cramping and nausea daily but it was getting better each day. The patient had bells palsy on right side of body after she took Covid Vaccine. In 2022, she also took her flu shot. The reporters causality for the event(s) of Bells Palsy on right side of body, Lethargic and Nausea with Upadacitinib Modified-Release Tablet was Not Provided. The reporters causality for the event(s) of stomach cramps with Upadacitinib Modified-Release Tablet was Reasonable Possibility. AbbVies opinion was that the causality for the event(s) of Bells Palsy on right side of body, stomach cramps, Lethargic and Nausea with Upadacitinib Modified-Release Tablet was Not Provided. Did Reaction Abate After Stopping Drug and Did Reaction Reappear After Reintroduction: Na.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information in the case , a possible causal association between  all  the reported events Bell's palsy, Lethargy, Nausea, Abdominal pain upper and the suspect drug cannot be 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 RAs, Ethics Committees, and Investigators, as appropriate.