Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Illness, Myalgia, SARS-CoV-2 test
Clinical narrative: After both injections, my blood pressure was elevated for approx 21 days at 180's to 190's over 140's; increased fatigue; I ran a consistent temp of 99.8 to 100.3; muscle aches; ill; elevated heart rate; This is a spontaneous report received from a Nurse.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Feb2021 at 17:15 as dose 2, single (Lot number: EN9581) at the age of 54 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "Drug allergy: Morphine". Vaccination history included: BNT162b2 (Dose 1, single, Batch/Lot No: EL3247, at 17:15 Intramuscularly into the left arm), administration date: 22Jan2021, when the patient was 54-year-old, for Covid-19 immunization, reaction(s): "blood pressure was elevated for approx 21 days at 180's to 190's over 140's", "increased fatigue", "muscle aches", "heart rate stayed elevated", "ran a consistent temp of 99.8 to 100.3/I ran a temp of 100.0 to 100.8". The following information was reported: BLOOD PRESSURE INCREASED (medically significant), outcome "unknown", described as "After both injections, my blood pressure was elevated for approx 21 days at 180's to 190's over 140's"; FATIGUE (non-serious), outcome "unknown", described as "increased fatigue"; BODY TEMPERATURE INCREASED (non-serious), outcome "unknown", described as "I ran a consistent temp of 99.8 to 100.3"; MYALGIA (non-serious), outcome "unknown", described as "muscle aches"; ILLNESS (non-serious), outcome "unknown", described as "ill"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "elevated heart rate". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: elevated, notes: blood pressure was elevated for approx. 21 days at 180's to 190's over 140's; Move into High ranges; Body temperature: 100 to 100.8, notes: ran a temp of 100 to 100.8; Heart rate: stayed elevated; SARS-CoV-2 test: Negative.  Clinical course: It was reported that the patient's BP and heart rate began to normalize the week before the 2nd dose. However, after the 2nd dose she  experienced the same symptoms as the first dose, she ran a temp of 100 to 100.8, heart rate stayed elevated and BP moved to high range; blood pressure was elevated for approx 21 days at 180's to 190's over 140's. It was also reported that she was prone to increased BP when she was ill and with elevated heart rate.  No follow-up attempts are possible.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events BLOOD PRESSURE INCREASED and the suspect drug cannot be excluded. 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.,Linked Report(s) : US-PFIZER INC-202200346958 Same patient/drug/AE, different dose;