Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure, X-ray
Clinical narrative: blood pressure; his heart rate was 140/heart was pounding; cough; feeling really bad; he had sweats; had an accelerated heart rate /rapid heart beat; he received the Pfizer COVID vaccine in Apr and then the second dose in May. Caller reported that he contracted COVID in Sep; he received the Pfizer COVID vaccine in Apr and then the second dose in May. Caller reported that he contracted COVID in Sep; couldn't get his breath; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A 52-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA Vaccine, solution for injection, Batch/Lot Number: ER8736; Expiration Date: 31Jul2021), via an unspecified route of administration, administered in Arm Left on 14May2021 14:00 (at the age of 52-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing Barrett's esophagus and had the flu vaccine in 2019. Concomitant medication included lansoprazole (PREVACID) taken for Barrett's esophagus from an unspecified start date and ongoing. Patient previously took first dose of bnt162b2 (Lot number: EW0162) administered in left arm on 23Apr2021 at 13:00 (at the age of 52-years-old) for covid-19 immunisation and patient experienced fatigue and sore arm. The patient received the pfizer covid vaccine in apr and then the second dose in may. Patient reported that he contracted covid on 01Sep2021 and had an accelerated heart rate /rapid heart beat on 13Sep2021. On 13Sep2021 20:00, he had sweats, so he took his temperature and it was normal; but his heart was pounding. He put on the pulse ox and his oxygen was fine but heart rate went from 80 to 140. On an unspecified date in Sep2021, he couldn't get his breath. On an unspecified date, blood pressure, his heart rate was 140 and had cough. The beginning of this month he was in the hospital diagnosed with COVID. The first time he went to the hospital he drove himself and was in the ER for observation. The other day he had to call an ambulance because his heart rate was out of control. The ER did give him an EKG and said his heart was fine. He was at the PCP office 31Aug2021, who referred him to the hospital, he thought he had bronchitis, but the doctor said he had no wheezing or rattles in his chest; and his EKG was fine. He sent him to the hospital to take a COVID test. They did blood work, EKG and COVID test and then let him drive home. He was prescribed 50mg prednisone and albuterol inhaler. After two weeks of the steroids was when he got the rapid heart rate. He had no other treatment. His test was positive on 1Sep2021. Then around Labor Day, 5Sep2021 or 6Sep2021 he was feeling really bad and couldn't get his breath and he called his doctor who sent him to the hospital to check his lungs, heart and make sure everything was okay. They did not admit him. They said if he had the vaccine he should be okay and his vitals were good and his oxygen was 98%. They told him the majority of people who are admitted are not vaccinated and have an O2Sat of 80. Then he went by ambulance on 13Sep2021 to the hospital. States his blood pressure was 155/94 and his heart rate was 140. He was evaluated for pneumonia and blood clots, they checked his heart and did a few other things. They released him to go back home. Now, today (on reporting date), he feels he is between persisting and recovered with the COVID. Some days he feels really good and then the next day he couldn't get out of bed. Since Monday he has felt pretty good but today is probably the best he has felt. Adds on average his heart rate is 50 to 60. Today it could be elevated to the 70s due to the steroids and the albuterol but he has not had anymore rapid heart rate; it was in the low 80s to upper 70s today but not going crazy. None of additional Vaccines were Administered on Same Date of the Pfizer Suspect. The patient had not received any other vaccine within 4 weeks, the Pfizer vaccine was the only thing he has had since he had the flu vaccine in 2019. Caller stated in 8 months the immunity was dropping, how much was it dropping each month. Is there a blood test to see how much of the vaccine was running through your body. Caller asked when will the booster dose be offered to everyone. Caller stated he heard on the news that after 8 months of second dose of covid vaccine people will be able to receive the third dose. Caller asked if there is any CDC guidelines on how to clean your home after covid 19 infection, Caller asked how long would a person be contagious after covid 19 infection (reporters question). The patient underwent lab tests and procedures which included blood pressure: 155/94 on 13Sep2021, blood work: unknown result on an unspecified date (they did blood work, EKG and COVID test and then let him drive home), EKG (electrocardiogram): normal on 01Sep2021, electrocardiogram: normal on 05Sep2021, electrocardiogram: normal on 13Sep2021, heart rate: 50 to 60 on an unspecified date, heart rate: 80 to140 on 13Sep2021, heart rate: 140 on 13Sep2021 heart rate was 140, heart rate: low 80s to upper 70s on 15Sep2021, oxygen saturation: fine % on 13Sep2021 (his oxygen was fine), oxygen saturation: 98 % on Sep2021, sars-cov-2 test: positive result on 01Sep2021, x-ray: unknown result on an unspecified date (did go to the hospital twice for x-rays). Therapeutic measures was given for COVID, he was prescribed prednisone and albuterol inhaler. After two weeks of the steroids was when he got the rapid heart rate. He had no other treatment. Outcome of events contracted covid in sep and accelerated heart rate /rapid heart beat was recovered on an unspecified date in 2021. Outcome of events he had sweats, he couldn't get his breath, blood pressure, his heart rate was 140, feeling bad were unknown while cough was not recovered.  Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot ER8736 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot ER8736, fill lot EP8688, and the formulated drug product lot EP8585. 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.  No follow-up attempts are possible. No further information is expected.