Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Stress, Transient ischaemic attack, Ulcer
Clinical narrative: Ulcer; Stress; Flu like symptoms; Generalized aching; Headache; Eye ache; Generalized aching; Transient ischaemic attack; Elevated BP; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer. The reporter is the patient. Other Case identifier(s): 21K-163-4179914-00 (AbbVie).  A 45 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Apr2021 (Batch/Lot number: unknown) at the age of 45 years as dose 1, single, intramuscular, administration date 20May2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster) , single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) as citrate free for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: TRANSIENT ISCHAEMIC ATTACK (non-serious) with onset 2021, outcome "unknown", described as "Transient ischaemic attack"; ULCER (non-serious), outcome "recovering", described as "Ulcer"; BLOOD PRESSURE INCREASED (non-serious) with onset 2021, outcome "recovered" (2021), described as "Elevated BP"; INFLUENZA LIKE ILLNESS (non-serious) with onset May2021, outcome "recovered" (2021), described as "Flu like symptoms"; PAIN (non-serious), PAIN (non-serious) all with onset May2021, outcome "recovered" (2021) and all described as "Generalized aching"; HEADACHE (non-serious) with onset May2021, outcome "recovered" (2021), described as "Headache"; EYE PAIN (non-serious) with onset May2021, outcome "recovered" (2021), described as "Eye ache"; STRESS (non-serious), outcome "unknown", described as "Stress". The patient underwent the following laboratory tests and procedures: blood pressure abnormal: (2021) elevated. The action taken for adalimumab was unknown.  Clinical course: On unknown dates, the patient experienced ulcer flares and stress. in 2021, the patient experienced almost had a stroke after covid-19 vaccine and blood pressure escalated. in may 2021, the patient experienced felt like the flu, body ache, headache and eye ache. in 2021, the blood pressure escalated, felt like the flu, body ache, headache and eye ache resolved. The patient had no known allergies. It was unknown if patient was enrolled in a covid-19 vaccine trial. The reporter's causality for Humira (adalimumab) with all the events had no reasonable possibility. The reporter's causality for Pfizer BioNTech Covid-19 Vaccine with the event of Ulcer was not reported and all the other events was possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  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