Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chest pain, Electrocardiogram, Heart rate increased
Clinical narrative: heart rate accelerated; blood pressure is elevated to 135/90 mmHg, which is abnormal for her/Blood pressure went up; Chest pain; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0161, Expiry date: unknown) intramuscular, administered in left arm on 10Apr2021 15:56 pm (age at vaccination was 28 years) at a single dose for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included betamethasone dipropionate, ketoconazole (KETO B). The caller reported that after receiving her first dose of Pfizer-Biontech covid19 vaccine on 10Apr2021 she had symptoms. Later that night her heart rate accelerated. She experienced chest pains and her blood pressure went up. She went to the urgent care and had an EKG. The result was normal with no abnormal findings. She reported increase heart rate latest for 4 days. The chest pain lasted for 5-6 days. She did not have a primary care provider. She was going to get her blood pressure checked today. On 15Apr2021, she reported that her blood pressure was elevated to 135/90 mmHg, which was abnormal for her and blood pressure went up. She asked whether she should she continue with the second dose. She had a side effect after the first dose of the vaccine. It was 135/90 at the Urgent Care. She was asking if she should move forward to get the second dose or stay with the one. She was not sure how it would effect her later on and she wanted to be safe. She asked whether she would experience harmful effects if she did not get the 2 doses of the vaccine. She received a response stating that there were no reports of increased heart rate or blood pressure during clinical trials. Further she received a response from HCP that stated as noted in the Fact Sheet for Recipients, she should not get the Pfizer-BioNTech COVID-19 Vaccine if she had a severe allergic reaction after a previous dose of the vaccine or if she had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. They referred her to speak to her healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Her healthcare provider knows her health situation and has access to information that can better help inform this decision. The patient reported AEs after receiving her first dose of Pfizer-Biontech covid19 vaccine on 10Apr2021. She wanted to know if she is at risk of any additional adverse events, if she were to only get one dose. She received a response which stated that the commonly reported AEs were reported after both the first and second doses.  Efficacy was determined 7 days after the second dose was given, no data on how well patients are protected by just one dose. Not aware of other risks for getting only one dose of vaccine instead of the recommended two. The patient did not have a history of previous immunization with the Pfizer vaccine considered as suspect. The patient did not receive 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 outcome of the events heart rate accelerated and blood pressure is elevated to 135/90 mmHg, which is abnormal for her/Blood pressure went up was unknown. The outcome of the event chest pain was recovered/resolved with sequel on 15Apr2021.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained. No further information is expected.  Follow up (20Apr2021): New information received from a contactable consumer in response to Non-HCP letter sent to consumer included: Added new event Chest pain and its details, onset date of the event (Blood pressure went up), concomitant medication (betamethasone dipropionate, ketoconazole (KETO B) and the clinical details.