Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drug ineffective, Dyspnoea, Fatigue
Clinical narrative: positive for COVID; positive for COVID; like a bad flu; shortness of breath with activity; Headache; head congestion; Fatigue; mild coughing to bring up flem; This is a spontaneous report from a contactable nurse (patient).   A 71-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6201, Expiry date: not reported), via an unspecified route of administration in left arm on Feb2021 as dose 1, single for covid-19 immunisation and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8730, Expiry date: not reported), via an unspecified route of administration in left arm on 29Mar2021 15:00 (at age of 71-years-old) as dose 2, single for covid-19 immunisation. Medical history included covid-19 from Dec2020 to an unknown date States he and his wife got the COVID virus back in Dec2020. Patient's medical history (including any illness at time of vaccination) were none. Family medical history relevant to adverse event were none. There were no concomitant medications. The patient had not received any other vaccine within 4 weeks. There were no adverse events following prior vaccinations. Additional vaccines administered on same date of the bnt162b2 suspect were none. On 15Sep2021, the patient experienced positive for covid, like a bad flu, shortness of breath with activity, headache, head congestion, fatigue, mild coughing to bring up flem. Registered nurse called regarding the bnt162b2 vaccine. Stated he and his wife got the COVID virus back in Dec2020. Added he thought he might have more immunity having had it and then getting the shot. Added their symptoms were very minimal and they were told to wait 90 days for the COVID vaccine. Reports they got the vaccine in Mar2021; then on the 16Sep2021 he was positive for COVID. Added he imagined it was the new variant. His wife also had symptoms at the same time. Patient mentioned that he ate a low carb diet, he had eliminated sugar, and had lost 90 pounds; he thought low sugar helps and that a high blood sugar puts you at risk. Reports he noticed symptoms of the virus and got tested on 15Sep2021. He experienced fatigue; shortness of breath with activity; headache; mild coughing to bring up flem; head congestion. Stated the head congestion had been the worst for him and wife. Rated his events all as medically significant. States he was improving. The adverse events did not result in Emergency Room or Physician office visit. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 15Sep2021. Treatment: Reports he tested positive for COVID and went into isolation. Therapeutic measures were taken as a result of the events. The outcome of the events like a bad flu, shortness of breath with activity, headache, head congestion, fatigue, mild coughing to bring up flem was recovering. Indication was he wanted to prevent COVID. When asked causality he stated no, not related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on available information and a possible contributory role of suspect product BNT162B2 to the development of events covid19, drug ineffective, influenza like illness, dyspnoea, headache, head discomfort, fatigue and cough cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.