Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: After getting the two doses of Pfizer vaccine, she tested positive with COVID; Positive with COVID; Sent me for a COVID test which came out positive; After getting the two doses of Pfizer vaccine, she tested positive with COVID; Positive with COVID; Sent me for a COVID test which came out positive; Fever; Got the fever; Feel like I am getting over cold, do not feel badly; This is a spontaneous report from a contactable Nurse (patient) reported herself that an 80-year-old female patient received bnt162b2 (formulation: solution for injection; NDC number; UPC number; Expiry Date: Unknown), dose 1 via intramuscular route administered in right deltoid on 27Feb2021 (Lot Number: EM9810) as dose 1, single and dose 2 via intramuscular route administered in right deltoid on 30Mar2021 (Lot Number: EN6206) as dose 2, single (both doses at the age of 80 years) for covid-19 immunisation. Medical history included ongoing hypertension, ongoing blood cholesterol increased and malignant melanoma from an unknown date, she reported that she had a history of malignant melanoma, but she has no malignant melanoma that is active now. Concomitant medications included bisoprolol fumarate/ hydrochlorothiazide (ZIAC) and atorvastatin taken for blood cholesterol increased, start and stop date were not reported. The patient mentioned that after getting the two doses of Pfizer vaccine, she tested positive with COVID. Now she would like to report that and she would like to know as well on what she needs to do since right now she was positive with COVID. Consumer stated, right, six months later. She had the vaccine in February and March then just last Wednesday the 11Aug2021, the night before she had a fever of 101 on 11Aug2021 and so she went to the doctor next day, they sent her for a COVID test which came out positive on 12Aug2021. They then gave her the monoclonal antibodies (treatment) on the next day, on the 12th and she had no reaction, no serious, any problem at all. She felt like she was getting over cold that were her symptoms but she do not feel badly in Aug2021. She reported that, her concern was 2 things mainly when can she safely be re-tested and know that it's accurate and how long does she have to, they told her 11 days to quarantine which she is doing now, she was staying in her house, not going anywhere, not doing anything except her housework. And so, she concerned about how long is safe to be anywhere out and do you know anything more about virus 'shedding' from this? And specially after she have had the monoclonal (incomplete sentence). She was concerned about how much virus shedding information she can get because she does not know how dangerous was, she to other people after quarantine. She reported that, it was just last week that she got the fever that dropped her to the doctor for the test. She will be 81 till January. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient stated that she has been digging answers for her questions yet, but she knows they have got all the information down she hopes she do not need to give it all again. She really needs to know when to be re-tested and how safe it would be. Consumer was informed that Pfizer Medical Information is the right department to answer that question. The patient underwent lab tests which included fever/ got the fever was 101 on 11Aug2021 and covid-19 was positive on 12Aug2021. Therapeutic measures were taken as a result of the events covid-19, pyrexia and nasopharyngitis with Monoclonal Antibody (It is Regen-Cov, that was the 'Casirivimab'). The outcome of the events fever and Cold was unknown at the time of report.  Causality: Consumer stated, "It didn't cause me any discomfort. I didn't have any problem at all with it, I get no reaction that was painful or discomforting or anything. I really didn't even get a swollen arm."; Sender's Comments: Based on the current available information, a possible role of the suspect product BNT162B2 to the development of events vaccination failure and covid19 cannot be totally 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.