Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: diagnosed with Covid-19; diagnosed with Covid-19; This is a spontaneous report from a contactable consumer (Patient) via Medical Information Team. A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation, Solution for injection, Batch/Lot Number: EP7534; Expiration Date: 31Jul2021) via an unspecified route of administration, administered in right arm on 23Mar2021 (at the age of 59-years-old) as dose 1, single for COVID-19 immunisation.  Medical history included diabetes mellitus. He has been diabetic a long time. Concomitant medication(s) included metformin (MANUFACTURER UNKNOWN) taken for diabetes mellitus. There was no history of previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of Pfizer suspect. The patient did not receive any vaccines four weeks prior vaccination. It was reported that the patient received Pfizer covid vaccine on 23Mar2021. They made him sit for half an hour. He was supposed to get his second shot on 13Apr2021, but he was diagnosed with Covid-19 on the fourth or fifth of April. He went to the emergency Room during the night because he was not feeling that good. He waited for 3 hours and saw the doctor at 4 AM. Blood work has been good. Patient was hospitalized for the event. When he went to the hospital the doctor said the first shot was working and that was why his symptoms weren't so bad. Then they gave him the antibodies. He spent 3 days in the hospital. He did not have to have oxygen. Upon discharge the doctor said he had to wait 90 days to get the second shot. His primary care provider told him that he needs to start the series over. When the Patient went to receive the second dose, he was told that Pfizer told them that he should not get vaccinated. Patient clarified that his first dose was given by a man at the vaccine at a clinic at County College. The lady said to start over and he was willing to start over. When he went to Pharmacy he was told that he could not start over and he couldn't get the shot. He doesn't see Pfizer on the vaccination card, but they told him it was Pfizer. Patient asked if he could take the second dose of the vaccine or do have start over, since he had Covid and was treated with antibodies. Patient was asking if he could get the second dose, or will he be starting all over again. The patient underwent lab test in which blood test: good, and SARS-COV-2 test: Positive on an unspecified date. The patient received treatment for event. The outcome of the event was unknown.  Upon follow-up received from a Product Quality Complaint Group on 21Jul2021, the following was included: This report included Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EP7534 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 EP7534, fill lot EP7532, and the formulated drug product lot EP7528. A complaint sample was not returned, and photographs were not received. There were no deviations that may have caused a complaint of this nature. 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.  Follow-up attempts are completed. No further information is expected.