Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: has been home with COVID-19; has been home with COVID-19; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from product quality group. The reporter is the patient.  A 64-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: EN6201), on 27Feb2021 as dose 2, single (Lot number: EN6201) and on 31Dec2021 as dose 3 (booster), single (Lot number: FJ8766) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "sugar", start date: 2017 (unspecified if ongoing), notes: She started Metformin probably 5 years ago; "diabetic" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN 1000mg in the morning and 1000mg in evening with dinner taken for blood glucose increased, start date: 2017. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Jul2022, outcome "unknown" and all described as "has been home with COVID-19". The event "has been home with covid-19" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) negative, notes: On Saturday, she took a COVID test and was negative; (2022) negative, notes: she retested on Sunday and was negative; (25Jul2022) positive, notes: On Monday she did a test and was positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that, patient took paxlovid (3 tablets in the morning and 3 tablets in the afternoon) from 25Jul2022 to 29Jul2022 for COVID treatment. Additional Information for Other medicines Metformin: She started this probably 5 years ago. When she was pregnant, she had high sugar and was okay after she had her daughter and then started gaining weight and was started on Metformin. She has been home with COVID-19 and took Paxlovid and finished the 5 day course on Friday. On Saturday, she took a COVID test and was negative and she retested on Sunday and was negative. On Monday after her 3rd test, she showed positive and she knows for sure she has rebound COVID. She has had all the vaccines and booster shots and she was calling because she thinks she needs to be reporting this and knows the percentage of rebound COVID is a low percentage. She went to her doctor because she was a diabetic. She wants to go back to work and went to work yesterday because was negative Saturday and Sunday but was feeling really tired and she was usually a very hyper person. She went to the doctor and took a test and her doctor told her she was positive. She read about the medication and thought she had rebound. Today she was still tired. She just has the 3 shots. She has never had any symptoms or a bad experience with the 3 shots. Vaccine was not administered at facility. No additional vaccines administered on same date of the Pfizer suspect. AE was not related to emergency room. No prior vaccinations (within 4 weeks). AE(s) following prior vaccinations was reported as none. She had no fever or pain and other people have a lot of side effects but she had nothing. Patient's Medical History (including any illness at time of vaccination) was reported as none.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162b2 to the reported events of vaccination failure and COVID-19 cannot be ruled out given the known suspect product profile and temporal association.