Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Back pain, Haemorrhage, Musculoskeletal stiffness, Rheumatoid arthritis
Clinical narrative: Flareups from Rheumatoid arthritis; Lower back pain; Anemia; Stiff in the morning; Bleed to death; Complications fro COVID shot/Almost had a heart attack; 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-163-4362077-00 (Agency).  A 42-year-old female patient received BNT162b2 (BNT162B2), on 09Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 42 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) till Mar2022 at unk, citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1:, Daily Dose: 1) First Dose (1 in 1 Once) , Route Of Administration: 1) Intramuscular , Indications For Use: COVID-19 Vaccination), administration date: 17Mar2021, when the patient was 42-year-old, for COVID-19 Vaccination. The following information was reported: VACCINATION COMPLICATION (non-serious) with onset 13Apr2021, outcome "recovering", described as "Complications fro COVID shot/Almost had a heart attack"; HAEMORRHAGE (medically significant) with onset 30May2021, outcome "unknown", described as "Bleed to death"; RHEUMATOID ARTHRITIS (medically significant), outcome "recovered", described as "Flareups from Rheumatoid arthritis"; BACK PAIN (non-serious), outcome "not recovered", described as "Lower back pain"; ANAEMIA (non-serious), outcome "unknown", described as "Anemia"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "Stiff in the morning". The action taken for adalimumab was unknown.  The reporter considered "bleed to death", "complications fro covid shot/almost had a heart attack" and "anemia" related to BNT162b2. The reporter's assessment of the causal relationship of "flareups from rheumatoid arthritis", "lower back pain" and "stiff in the morning" 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.  Causality for Humira (Adalimumab): The reporter's causality for the event (s) of complications from COVID shot/almost had a heart attack, bleed to death due to the COVID vaccine, anemia, flareups from rheumatoid arthritis and lower back pain with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event (s) of stiff in the morning was not provided.   Causality for Pfizer BioNTech COVID-19 vaccine(Tozinameran)(Tozinameran),unknown: The reporter's causality for the event (s) of complications from COVID shot/almost had a heart attack, bleed to death due to the COVID vaccine, anemia and Bleeding (Haemorrhage) with Pfizer BioNTech COVID-19 vaccine(Tozinameran)(Tozinameran),unknown  was Possible.The reporter's causality for the event (s)  flareups from rheumatoid arthritis ,lower back pain and  stiff in the morning with Pfizer BioNTech COVID-19 vaccine(Tozinameran)(Tozinameran),unknown was not provided.   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 available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available.  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.