Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Haematochezia, Hypersensitivity, Pain in extremity, Pneumonia
Clinical narrative: every time eats lettuce, shows blood in stool; Pneumonia; reoccurring urinary tract infections; sick with allergies; bronchitis; sore arm; 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-163-4318495-00 (Agency).  A 65-year-old female patient received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years and on 08Apr2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1159438) at unk (citrate free), subcutaneous for colitis ulcerative, crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered", described as "sore arm"; HAEMATOCHEZIA (medically significant), outcome "recovered", described as "every time eats lettuce, shows blood in stool"; PNEUMONIA (medically significant), outcome "recovering"; URINARY TRACT INFECTION (non-serious), outcome "unknown", described as "reoccurring urinary tract infections"; HYPERSENSITIVITY (non-serious), outcome "recovered with sequelae", described as "sick with allergies"; BRONCHITIS (non-serious), outcome "recovering". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of haematochezia, pneumonia, pain in extremity, urinary tract infection, hypersensitivity, bronchitis.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of every time eats lettuce, shows blood in stool, sore arm, reoccurring urinary tract infections and sick with allergies with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of pneumonia and bronchitis was not provided.  Causality for Pfizer BioNTech COVID-19 vaccine (Tozinameran): The reporter's causality for the event(s) of every time eats lettuce, shows blood in stool, reoccurring urinary tract infections and sick with allergies, pneumonia and bronchitis was not provided. The reporter causality for the event "sore arm" was possible for Pfizer BioNTech COVID-19 vaccine (Tozinameran).  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 in the case report, a possible causal relationship between the reported events: "Blood in stool", "Pneumonia", "Pain in arm", "Recurrent urinary tract infection", "Allergy", "Bronchitis" and the suspect drug BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer drug 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.