Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Polymerase chain reaction, SARS-CoV-2 test negative, Type 2 diabetes mellitus, Vaccination failure
Clinical narrative: Medical Information Potential AE; she did a PCR test that resulted yesterday as positive; COVID-19 rapid POC test negative; she did a PCR test that resulted yesterday as positive; Feeling sick; Coughs often throughout the call.; Diagnosed with type 2 Diabetes; This is a spontaneous report from a contactable consumer (patient). A 70-years old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6205), via an unspecified route of administration on 01Mar2021 (at the age of 70-years-old) as single dose and the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 08Feb2021 (at the age of 70-years-old) as single dose for COVID-19 immunisation. The family medical history was reported as none. The patient's medical history (including any illness at time of vaccination) was reported as none. The patient's concomitant medications were not reported. Historical vaccine included Pneumonia vaccine (PNEUMOCOCCAL VACCINE), via an unspecified route of administration on an unspecified date as dose number unknown, single for an unspecified indication and experienced arm went numb, like paralyzed, for a day. The history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as first dose of the Pfizer COVID 19 Vaccine given on 08Feb2021, Lot Number: EN6201 or EN6207, uncertain if the last number was a 1 or a 7, given in the caller's left arm. The caller denied any medications, labs or treatments relevant to report. Stated that, she was diagnosed with type 2 diabetes last month, she has otherwise been healthy. Prior vaccinations (within 4 weeks) was reported as none. Additional vaccines administered on same date of the Pfizer suspect was reported as none. It was reported that, the information was verified with the caller. She was called to report that, she has tested positive for COVID 19 after having both doses of the Pfizer COVID 19 Vaccine. She has had COVID-19 for over a week. She had three tests done on 09Jul2021. The rapid test for COVID 19 came back as negative. The PCR test done on that date yesterday, resulted as positive. She also had an antibody test, IgG or IgM. On an unspecified date in Jul2021, the caller has been feeling sick for a week. Coughs often throughout the call. The caller stated that, she believed she got COVID 19 in an outdoor setting over the weekend. It was an outdoor block party on 04Ju2021. A family of 5 came down with COVID along with some others, including the caller. The caller thinks the efficacy wore off or she contracted one of the variants. Stated that, she was the only one out of the people infected who was vaccinated. The caller stated that, she had 2 telehealth appointments with her doctor after testing positive for COVID 19. One of them was yesterday or the day before and one was today. For Lack of Efficacy, the primary infection site was reported as respiratory. Stated that, she just wanted to report her test and sickness to help with data on the people who are still getting sick after the vaccine and she just wanted to help with the information for the variants of the virus, which are highly contagious. Response included no inquiry was made by the caller. The caller declined to provide healthcare professional information at this time. On an unspecified date, medical information potential AE was reported. The description of complaint included was the caller tested positive for COVID 19 after both doses of Pfizer COVID 19 vaccine. The events required a visit to the emergency room was reported as no and physician office was reported as yes. On 09Jul2021, the patient underwent lab tests and procedures which included antibody test, resulted as either the IgG or IgM, COVID-19 PCR test positive, resulted as positive and COVID-19 rapid POC test negative, resulted as negative. The outcome of the events was unknown.