Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, COVID-19, Cellulitis, Fatigue, Laboratory test
Clinical narrative: diagnosed with Covid-19 infection in August; diagnosed with Covid-19 infection in August/caught covid; Pneumonia; cellulitis; Afib; tired; This is a spontaneous report from a contactable consumer (patient). This 71-year-old male patient received bnt162b2 (Pfizer Covid Vaccine), dose 2 via an unspecified route of administration, administered in arm left on 15Feb2021 (Batch/Lot Number: EN6200; Expiration Date: Jun2021) as dose 2, single at the age of 70-year-old; dose 1 via an unspecified route of administration, administered in arm left on 26Jan2021 (Batch/Lot Number: EL3249; Expiration Date: May2021) as dose 1, single at the age of 70-year-old for covid-19 immunisation. Medical history included high cholesterol and high blood pressure. The patient previously took doxycycline hyclate and experienced feel like he was having a heart attack. Allergies: no but he cannot doxycycline hyclate, he was taking it one time, the urologist prescribed it and he couldn't take it, made him feel like he was having a heart attack, the doctor told him to throw it in the trash, he has no lot or expiry, it has been discarded. Patient states he believes he also had Covid-19 in Dec2019. Patient states he had his flu shot in Nov2019 and three weeks later was "as sick as a man could be." Patient states he had his nose swabbed and was diagnosed with a viral infection. Patient states he believes it to have been Covid-19, though this was not confirmed by a HCP or specific testing. Concomitant medication included he is seeing the cardiologist for high blood pressure, it is under control with medication that he is taking everyday. Patient states he was diagnosed with Covid-19 infection in Aug2021. Patient asking if he could or should get a booster dose of the Pfizer BioNTech Covid-19 Vaccine after having been infected with Covid-19. Patient states that he is calling about the Pfizer Covid Vaccine, he got vaccinated early in this new year, his first dose was Late Jan2021 and the second dose around was 01Mar2021 (later confirmed as 15Feb2021). Patient states that the vaccines didn't work, and he caught the covid virus around 01Aug2021. Patient states that he was in a hotel at # for 4 days, he had symptoms on 05Aug2021,06Aug2021, and 08Aug2021, when he came home he knew he had the vaccine so he thought he did not have the covid virus, but then he went to bed. He couldn't go on much anymore so then he went to Hospital, on 22Aug2021 he went to the Emergency Room, he was tested for the covid virus in the Emergency Room and then they admitted him on 22Aug2021, he was discharged on the evening of 24Aug2021. Patient confirms he was tested by a nasal Swab for the covd virus. Patient also add that he not only had covid but he also had pneumonia. Patient was probed if he was also tested for pneumonia, he states that he was so sick that he doesn't know. Patient states that he is calling today for the purpose of reporting, because he was vaccinated and still came down with covid. The first 2 vaccines didn't work. He also clarifies that when he went to the hospital, he did not see any physician that that he's been under care of, he saw hospitalists. Caught Covid Outcome: Patient is not sure if his covid virus has subsided, he is still tired, he doesn't know, his strength and energy is not back yet. His cardiologist also told him that he is going into Afib, he can't even say yes or no if he is in Afib. He also has swelling in the left leg and foot, but they told him it was cellulitis, they did an Ultrasound putting gel on his leg to look for blood clot, but there were no clots and the doctor said he had cellulitis there. The Afib and Cellulitis were observed after he came home from the hospital. When he was discharged from the hospital he came home with oxygen, it was a probe they stick up nose that he came home with for a while. Patient clarifies that he is gradually a little better. The heart doctor saw the Afib on 23Sep2021, during that appointment Afib was detected. He saw the heart doctor before on 24May2021 and everything was fine then, he did not have Afib then. he see's the heart doctor every 3-4 months. Patient does not know if the Afib is ongoing because he is going in and out of Afib and he is on medicine for that. The cellulitis was discovered on 30Sep2021, when he was at the heart doctor and he told them his foot was swollen, they were worried about the heart, and so they called the internist, and the internist wanted to have the foot checked. It's still swelling, and the more he's on his foot, the more it swells. He had medicine for it, it's not worsening, once he got back after the report and test they put him on medication, he is improving. The second dose was administered at a drive in clinic and so he knows it was on the left arm. He believes both vaccine were given in the left arm. Patient would like to see if its okay for him to get the booster. The patient was hospitalized for diagnosed with covid-19 infection in august/caught covid from 22Aug2021 to 24Aug2021. Therapeutic measures were taken as a result of afib and cellulitis. The outcome of event diagnosed with covid-19 infection in august/caught covid and cellulitis was recovering. The outcome of event tired was not recovered. The outcome of other event was unknown. Report from Product quality complaint included: This is a notification generated from the gQTS system. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according to in PQS Q1215 and/or Q1252. Refer to the below table for details: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EN6200 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EN6200, fill lot EN5332, and the formulated drug product lot EN5321. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL3249 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL3249, fill lot EL3232, and the formulated drug product lot EL3225. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.