Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Mixed connective tissue disease, Musculoskeletal stiffness, Nodule, Oropharyngeal pain
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4501257-00. A 60-year-old female patient received BNT162b2 (BNT162B2), on 02Dec2020 as dose 1, single (Batch/Lot number: unknown), on 07Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 04Feb2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years, all intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), since 01Oct2021 (ongoing) (Lot number: 1159488), oral for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MIXED CONNECTIVE TISSUE DISEASE (medically significant), outcome "not recovered"; AUTOIMMUNE THYROIDITIS (medically significant), outcome "not recovered", described as "Hashimoto's disease"; VIRAL INFECTION (non-serious), outcome "recovering"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Pain in arm"; ABDOMINAL DISCOMFORT (non-serious), outcome "not recovered", described as "Stomach upset"; BLOOD TEST ABNORMAL (non-serious), outcome "not recovered"; GINGIVAL INJURY (non-serious), outcome "not recovered", described as "Cuts on gum"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "not recovered", described as "Fingers stiffness"; NODULE (non-serious), outcome "not recovered", described as "Nodule on finger"; FOOT DEFORMITY (non-serious), outcome "not recovered", described as "Hammer toe"; RHINORRHOEA (non-serious), outcome "recovering", described as "Nasal discharge"; DIARRHOEA (non-serious), outcome "recovering", described as "Diarrhea"; HEADACHE (non-serious), outcome "recovering"; PYREXIA (non-serious), outcome "recovering", described as "low grade fever"; BLOOD CHOLESTEROL INCREASED (non-serious), outcome "not recovered", described as "High cholesterol"; OROPHARYNGEAL PAIN (non-serious), outcome "recovering", described as "Sore throat". The patient underwent the following laboratory tests and procedures: Blood cholesterol: high; Blood test: elevated; Body temperature: low grade fever. The action taken for upadacitinib was dosage not changed. Clinical course: On an unknown date, the patient experienced virus, sore arm, stomach upset, blood levels elevated, cut on gums felt like ulcers, both thumbs stiffness, nodules on knuckles, hammer toes on right foot, mixed connective tissue disease, Hashimoto, nasal drip, diarrhea, headache, low grade fever, high cholesterol and sore throat. Pfizer BioNTech covid-19 vaccine (tozinameran) was also considered suspect. The patient reported that Pfizer vaccine caused sore arm. It was unknown if she was enrolled in a covid-19 vaccine trial. The reporter's assessment of the causal relationship of "mixed connective tissue disease", "Hasimoto's disease", "viral infection", "stomach upset", "blood test abnormal", "cuts on gum", "fingers stiffness", "nodule on finger", "hammer toe", "nasal discharge", "diarrhea", "headache", "low grade fever", "high cholesterol" and "sore throat" 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. The reporter considered "pain in arm" related to BNT162b2. Causality for upadacitinib (RINVOQ): The reporter's causality for the event(s) of virus, sore arm, blood levels elevated, cut on gums felt like ulcers, mixed connective tissue disease, Hashimoto, nasal drip, diarrhea, headache, low grade fever, high cholesterol and sore throat with Rinvoq (Upadacitinib) was no reasonable possibility. The reporter's causality for the event(s) of stomach upset, both thumbs stiffness, nodules on knuckles and hammer toes on right foot with Rinvoq (Upadacitinib) was a reasonable possibility. 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, a possible contributory role of the suspect drug BNT162B2 to  the reported event Pain in arm, Diarrhea, Headache, Low grade fever cannot be completely excluded based on temporal association and known drug safety profile however, other event Mixed connective tissue disease, Hashimoto's disease, Viral infection, Stomach upset, Blood test abnormal, Gingival injury, Musculoskeletal stiffness, Nodule, Foot deformity, Rhinorrhea, Sore throat, High cholesterol is unrelated to suspect drug. 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