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Write-up: gastritis; heart burn; Chest pain; The EKG said she had a heart attack; This is spontaneous report from a contactable nurse (patient). A 38-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 13:00 at single dose at right arm for covid-19 immunization. Medical history included heart attack from Apr2019 to an unknown date, covid-19 from Jul2020 to an unknown date (really sick with it). The patient''s concomitant medications were not reported. Patient didn''t receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient got the first COVID19 vaccine and a few days after started having chest pain on 02Jan2021 at 1:00AM, event was serious per medically significant. She went to the doctor and they did an EKG on 08Jan2021. The EKG said she had a heart attack. The heart attack was about the time she had chest pain after the first injection. Patient called her doctor on Monday, 04Jan2021. She had a televideo appointment on 06Jan2021. She went to the doctor''s office and had EKG on 08Jan2021 and was sent to the hospital. She didn''t get admitted because there were no beds. Outcome of the event chest pain, she would say she had recovered on 02Jan2021 with lasting effects because she was in the hospital again for the same thing. She went to the hospital the second time for chest pain that woke her up on 11Jan2021. It started at like 3AM. She thought it was heart burn. She tried to go back to sleep. It continued while she was at work. She told her supervisor who sent her to the hospital. They did not admit her. They did do an EKG on 11Jan2021 and it was abnormal, but not indicative of heart attack. Thought it was gastritis. Her doctor thought the heart attack was on the 02Jan2021. The same thing happened with her heart and she had a heart attack in Apr2019. History of all previous immunization with the Pfizer vaccine considered as suspect was none. No additional vaccines administered on same date of the Pfizer suspect. Patient stated she didn''t go to the ER, but called doctor''s office on the following Monday. There was no adverse event following prior vaccinations. Outcome of event chest pain was recovered with sequel, and outcome of other events was unknown. Information on lot/batch number has been requested.; Sender''s Comments: Based on the available information, a possible contributory role of the suspect BNT162B2 in the development of the events chest pain and heart attack cannot be excluded. The events are confounded by the patient''s underlying cardiovascular conditions. The impacts of this report on the benefit/risk profile of the 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.
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