Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: Got 2 doses of the vaccine tested positive with the COVID-19 Virus; breakthrough infection/patient was just diagnosed last week Friday; Got 2 doses of the vaccine tested positive with the COVID-19 Virus; breakthrough infection/patient was just diagnosed last week Friday; Patient not feeling good; Severe Cold and Flu; Severe Cold and Flu; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EN6208), dose 1 via intramuscular route, administered in arm left on 26Mar2021 at 09:30 (at the age of 48-year-old) as dose 1, single and dose 2 (Batch/Lot Number: ER8729) via intramuscular route, administered in arm right on 16Apr2021 at 09:30 (at the age of 48-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included Levocetirizine as allergy medication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date in Jul2021, the patient experienced got 2 doses of the vaccine tested positive with the covid-19 virus; breakthrough infection/ patient was just diagnosed last week Friday and on an unspecified date in 2021, the patient not feeling good, severe cold and flu. The clinical course of the events was reported as: he mentioned that he got 2 doses of the vaccine and he was really glad to have the vaccine but unfortunately after that (incomplete sentence), well actually he got the 1st dose last 26Mar and the 2nd dose last 16Apr but unfortunately after a month he was tested positive with the COVID-19 Virus. He stated, he got diagnosed just last week and his shot were between 26Mar and 16Apr of this year and he did not have COVID before this ever. He stated that right now (as reported) since he was not feeling good he had some over the counter medication but when he first came down with this (COVID-19 Virus), the only thing I was taking was allergy medication. I take Levocetirizine (Intent: treatment), 5 mg and I take I once a day in the evening. Laboratory test: included sars-cov-2 test: positive on an unspecified date in Jul2021 and he stated, not for at least, he wanted to say 4 or 5 months, it was the last time he had lab test. Treatment in response to events: he stated, yes, he started on Nyquil and Dayquill and they were severe cold and flu. He took some Aspirin also. He added, that was everything, he just wanted to call and let Pfizer know what happened to see if they ever wanted more information. The outcome of the events was unknown.  Product quality complaints: Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EN6208 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EN6208, fill lot EN5338, and the formulated drug product lot EN5329. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.