Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for the covid virus after having both doses of the vaccine; Tested positive for the covid virus after having both doses of the vaccine; This is a spontaneous report from a contactable consumer (patient herself). A 65-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL0142) via an unspecified route of administration in left arm on 22Dec2020 12:00 as dose 1, single and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL0142) via an unspecified route of administration in right arm on 12Jan2021 as dose 2, single (at the age of 65-years-old) for COVID-19 immunization. Vaccination Facility Type was reported as Hospital. Vaccine was not administered at a facility. Patient medical history included Diabetes which was family related and was nothing to the vaccine, cholesterol, Hashimoto disease (hypothyroidism). The concomitant medications included ongoing metformin from 2001 at a dose and frequency of 500 mg, 3x/day with a daily dosing of 1500 mg taken for diabetes mellitus, Sitagliptin (JANUVIA [SITAGLIPTIN]) from 2013 at a dose and frequency of 100 mg, daily taken for diabetes mellitus, pioglitazone from 2015 at a dose and frequency of 45 mg, daily taken for diabetes mellitus, pravastatin from 2011 at a dose and frequency of 20 mg, daily taken for cholesterol, levothyroxine sodium (SYNTHROID) from 2001 at a dose and frequency of 125 ug, daily taken for Hashimoto Disease, hydroxyzine from 2016 at a dose and frequency of 50 mg, 4x/day with a daily dosing of 200 mg taken for itchy skin from diabetes, dulaglutide (TRULICITY) at a dose and frequency of 0.75 mg, single weekly with a daily dosing of 0.107 mg taken for diabetes. Patient stated it had truly been very helpful in keeping her A1C low, it has been great. Patient had the covid vaccine, both doses in December, and she just tested positive for the covid virus yesterday (08Jul2021 at 12:30). She had the first one on 22Dec2020, and the second one the first week or so of January, as best as she can remember without getting out her card. She stated she was a rehab nurse, and clarified she was a registered nurse. She was just diagnosed yesterday, and her daughter was an ER nurse, and she said they see their worse side effects days seven through eleven, and she was not there yet. She added, to her it was all of the above because she did not know yet what it was going to be, but it was very significant, but could be life threatening.  She states, she got the vaccine hoping to protect her and she did not feel like the vaccine caused her to get it, but it did not prevent her from getting it. She stated, she was tested monthly for covid and for antibodies and she was told less than a month ago, she had full antibody protection from her Pfizer vaccine. She confirmed her most recent test for antibodies was done late May2021 or Jun2021. Patient thought there was a need for the booster dose as was suggested by Pfizer as she had tested positive for COVID-19 after getting the vaccine. Patient did not receive any treatment for the adverse events. The reported seriousness criteria for the event was other medically important condition, medically significant. Relatedness of drug to reactions/events: Tested positive for the covid virus after having both doses of the vaccine using global introspection as the method of assessment was reported as unrelated. The adverse events did not result in emergency room or physician office visit. The lab test and procedures included COVID-19 nasal swab test with result as positive on 08Jul2021, COVID-19 antibody test with result as full protection on an unspecified date in late May2021 or Jun2021. Description of complaint included patient tested positive for the covid virus after having both doses of the Pfizer vaccine. The outcome of the events was not recovered.; Sender's Comments: As per the available information, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available. 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.