Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood pressure increased, Hypertension, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp (patient). A 60-year-old female patient received BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: ER8729, Expiration Date: UNKNOWN), via an unspecified route of administration, in left arm, on 19Apr2021 (at the age of 60-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient included atrial fibrillation from Jun2020 and ongoing patient stated she was diagnosed after the heart surgery, heart surgery on 20May2020 patient stated she had a new Tricuspid valve placed and she was in the hospital for two weeks during the surgery and she was still having some problems from the heart surgery, ongoing BP elevation patient stated about two weeks ago, her heart doctor kept her on a blood pressure medication, and she cannot provide the name, stroke on 27Feb2020 and ongoing, had hole in heart from birth and unknown if ongoing. The concomitant medications of the patient included apixaban (ELIQUIS) taken as blood thinners from Jun2020 and ongoing and metoprolol (METOPROLOL) taken for heart issues from Jun2020 and ongoing. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: ER2613, Expiration Date: UNKNOWN), via an unspecified route of administration, in left arm, on 26Mar2021, as single dose for COVID-19 immunisation and she also received flu shot on an unspecified date in Oct2020 (at the age of 59-years-old) and reported arm sore. There was no investigation assessment. There were no additional vaccines administered on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. The family medical history relevant to AE(s) was not provided. The relevant tests were reported as none. AEs prior vaccination was reported as arm sore. On 04May2021, the patient reported she's had severe arm pain on the arm with the injection (left). She stated she is still having the pain. it's like someone punched you in the arm with their fist, the pain was running my blood pressure so i had to go to the hospital/blood pressure elevated, 212/109 and atrial fibrillation on an unspecified date. The patient reported that her arm hurt so bad, pain, cannot put her arm behind her back, after second vaccine, it had been over 2 months since her arm hurting her, and she went to the emergency room and her blood pressure went way up and she had some heart issues and had atrial fibrillation two to 3 weeks after the second shot, and it lasted one day. She asked how long the pain will last and was anyone else reporting arm pain for this period of time. The patient was hospitalized as a result of events from 06May2021 to an unknown date. The patient visited emergency room. The patient underwent lab tests and procedures which included Blood Pressure elevated: 212/109 on 06May2021. Therapeutic measures were taken as a result of events that included, she took Tylenol. She reported that she was given medication in the hospital, cannot provide the name and the medication did help to bring her blood pressure down and she also did get a shot of a steroid states the steroid did help to relieve some of the arm pain. The outcome of the events having the pain. it's like someone punched you in the arm with their fist and the pain was running my blood pressure so i had to go to the hospital/blood pressure elevated, 212/109 was reported as unknown and the patient recovered from atrial fibrillation on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected. ; Sender's Comments: A causal association between BNT162B2 and the reported events atrial fibrillation, blood pressure increased and pain in arm cannot be completely excluded based on information provided. However, patient's underlying medical conditions atrial fibrillation, septal defect, heart surgery, hypertension and advanced age were confounders. 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.