Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Nasal congestion, Pulmonary congestion, Pyrexia
Clinical narrative: Is calling for himself. Stated that he tested positive for Covid 19 this morning; tested positive for COVID-19 this morning, that the caller had the 3 dose primary series and booster dose; chest congestion; Cough; nasal congestion.; that he is feeling nasal congestion and fever; This is a spontaneous report received from contactable reporter(s) (Physician) from medical information team and product quality group for a Pfizer sponsored program. The reporter is the patient.  A 76 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 22Sep2021 (Lot number: FF2188) at the age of 76 years as dose 3  (booster), single, administration date 26Jan2021 (Lot number: EN5318) as dose 2, single and administration date 05Jan2021 (Lot number: EJ1686) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 07Mar2022, outcome "unknown", described as "Is calling for himself. Stated that he tested positive for Covid 19 this morning"; COVID-19 (medically significant) with onset 07Mar2022, outcome "not recovered", described as "tested positive for COVID-19 this morning, that the caller had the 3 dose primary series and booster dose"; PULMONARY CONGESTION (medically significant) with onset 05Mar2022, outcome "not recovered", described as "chest congestion"; COUGH (medically significant) with onset 05Mar2022, outcome "not recovered", described as "Cough"; NASAL CONGESTION (non-serious) with onset 05Mar2022, outcome "not recovered", described as "nasal congestion."; PYREXIA (non-serious) with onset Mar2022, outcome "unknown", described as "that he is feeling nasal congestion and fever". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Mar2022) positive, notes: he tested positive with a Binax this morning. Therapeutic measures were not taken as a result of vaccination failure, covid-19, pulmonary congestion, cough, nasal congestion, pyrexia.  Clinical course: The report was related to a study or programme. There was no patient history. Medical doctor mentioned that he already got Covid 19 vaccine three doses (booster shot). Stated that he was feeling nasal congestion and fever and was calling for himself. Stated that he tested positive for Covid 19 this morning. Agent stated that he was interested in getting Paxlovid pill. Clarified that he had chest congestion, cough and nasal congestion. Stated that he tested positive with a Binax this morning and was a senior citizen. Stated that the symptoms began on Saturday. Stated that he told her he was trying to get ahold of course of Paxlovid for himself due to the high risk for his age and weight. Stated that he tried (withheld) and (withheld) and no one seems to have it. Wanted to prescribe it for himself. Stated that he wanted to start it before it got too far into the course. Stated that the symptoms within the last 48 hours. Clarified that he received both the primary and secondary doses in Jan2021 and got the booster after in Sep2021. Stated that it has been eight months since that time. Stated that he was just trying to locate the drug. Later clarified that that none of the Covid vaccine doses have no relation to his current situation. Product details included: Provided an additional probable lot for the booster dose of FF2188. Initially provided that the first dose was 26Jan2021 but later clarified that it was given on 05Jan2021 with lot number of EJ1686. Stated that the second dose was given on 26Jan2021 with a lot number of EN5318.  Relatedness of drug to reaction(s)/event(s): Reactions assessed: Chest congestion, cough, Nasal congestion, Stated that he tested positive for Covid 19 this morning ; Source of assessment: Primary Source Reporter; Method of assessment: Global Introspection; Drug result: Unrelated; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event and the use of suspect product BNT162B2 cannot be fully excluded.