Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sneezing, Vaccination failure
Clinical narrative: Tested positive for Covid/Had both Covid vaccines back maybe in April/May 2021 and tested positive for Covid on 01Aug2021; Tested positive for Covid/Had both Covid vaccines back maybe in April/May 2021 and tested positive for Covid on 01Aug2021; lots of sneezing; congestion; coughing that had gone through her chest; blood pressure was sky high and she doesn't have blood pressure issues; ECG on her Apple watch it keeps alerting her of a sinus rhythm problem; had a high heart rate; doesn't feel well; these are not mild symptoms; it's weird; This is a spontaneous report from a contactable consumer reported for a patient (reporter's friend). A 60-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in arm on an unknown date in 2021 (age at vaccination was 60 years) as dose 1, single and second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in arm on an unknown date in 2021 (age at vaccination was 60 years) as dose 2, single for COVID-19 immunization. The patient did not have any medical history or illness. The patient did not have any family history relevant to AE. Concomitant medications were not reported. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines were 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 reporter reported that she and her sister had a friend (patient) who was fully vaccinated with Pfizer COVID vaccine she believes back in April/May2021. The patient got both of the Pfizer vaccines not too long before around April/May2021 when they first opened the gates up for her to get it. She did what she was supposed to do and got it like she was supposed to and at the 21 days. The reporter was unable to provide dates vaccines given, NDC, Lot, or expiry for either dose. Unable to provide which area/arm vaccines were given in. On 30Jul2021, the patient had lots of sneezing that started immediately, recently and that was why the patient went to get tested. Then the congestion and coughing began (coughing that had gone through her chest). So, the sneezing, coughing, and congestion started. On an unknown date in Jul2021, her blood pressure was sky high, and she doesn't have blood pressure issues. On her ECG on her apple watch it keeps alerting her of a sinus rhythm problem. She had a high heart rate and didn't feel well, and these were not mild symptoms. The shy high blood pressure has been gradual and then she started having the sinus rhythm, heart rate, and it was weird within the last couple of days. Maybe the heart rate and sinus rhythm started the day before, was not really sure. She then went to get tested about 5 days before on 01Aug2021 because she wanted to be sure and knew that you can get COVID even being vaccinated, and that the variant was spreading. The test result on 01Aaug2021 came back positive. People think just because you get the vaccine you can't get COVID, but she knew enough still even after getting her vaccines she should be tested because she people did not test themselves. Believes friend had called her physician but did not know if she went in to be seen because usually when the patient was tested positive the doctors did not see the patient. The caller stated friend was like today and yesterday having more symptoms and was in the active disease phase if that makes sense. The was no new or worsened symptoms/signs during the COVID-19 illness experienced (including date of onset/worsening). It was unknown if the patient had SARS-CoV2 antibodies at diagnosis. The patient displayed clinical signs at rest indicative of severe systemic illness which included lots of sneezing, coughing, blood pressure shy high, doesn't feel well, ECG on her Apple watch it keeps alerting her of a sinus rhythm problem. The patient was not hospitalized nor admitted to an intensive care unit. The patient not required supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. The adverse did not require a visit to emergency room or physician office. The patient did not receive any additional therapies for COVID-19. The event did not require the initiation of new medication or other treatment or procedure. It was unknown that how many days from the SARS-CoV2 diagnosis did it take before the SARS-CoV2 antigen test became negative. The patient underwent lab tests which included COVID testing PCR: positive on 01Aug2021, blood pressure: high, (ECG) electrocardiogram: alerting her of a sinus rhythm problem and heart rate: high on an unknown date in Jul2021. The was a product complaint. The description of complaint was reported as had both COVID vaccines back maybe in April/May2021 and tested positive for COVID on 01Aug2021. Unable to provide dates, NDC, Lot, or expiry for either COVID dose. The patient was still in active disease phase. The outcome of the events was not resolved.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.