Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Investigation, Vaccination failure
Clinical narrative: Tested positive for COVID virus; Tested positive for COVID virus; This is a spontaneous report from a contactable consumer (patient's wife). A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), first dose via an unspecified route of administration on 17Feb2021 (at the age of 73-year-old, Lot number: EL9266), second dose via intramuscular in muscle left arm on 10Mar2021 (at the age of 73-year-old, Lot number: EN6208); Both as a single dose for COVID-19 immunization/ did not want to get COVID. The patient's medical history and concomitant medications were none. Family medical history relevant to adverse events was none. No previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No additional vaccines administered on same date of the Pfizer Suspect. No adverse events following prior vaccinations. No illness/adverse event. No relevant medical history including but not limited to these conditions: Diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patient was not a smoker/former smoker. The patient was not taking any medications routinely prior to the event being reported. No pre-existing diseases worsened during the SARS-CoV2 infection. The patient has not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. Reporter reported she and her husband were fully vaccinated with the COVID vaccine and then recently on 09May2021 they both tested positive for COVID virus. Received his first COVID vaccine on 17Feb2021 and the second dose on 10Mar2021 and then tested positive for COVID virus on 09May2021. He got the test where you know about results 10 hours later. Unsure which COVID testing he had done. States after he tested positive for COVID he experienced sore throat, severe cough for 3 weeks, fever that got up to 100, and for 2 weeks they were very careful to watch his oxygen levels with an oximeter at home. The patient just tested oxygen levels with oximeter at home. They were pretty paranoid on an unspecified date in 2021 for a while. He was also given monoclonal antibodies at (withheld) Hospital on Wednesday, 12May2021. States that the next day no one called them to ask anything, and she was wondering if this was an experimental treatment. The adverse events did not require emergency room and required physician office visit. It was unknown whether the patient have SARS-CoV2 antibodies at diagnosis or not. The patient was not hospitalized. The patient was not admitted to an intensive care unit. The patient did not experience respiratory, dyspnea, tachypnea, hypoxemia, COVID-pneumonia, respiratory failure, Acute Respiratory Distress Syndrome (ARDS), cardiovascular, heart failure, cardiogenic shock, acute myocardial infarction, arrhythmia, myocarditis, gastrointestinal/hepatic, vomiting, diarrhea, abdominal pain, jaundice, acute liver failure, vascular, deep vein thrombosis, pulmonary embolism, limb ischemia, vasculitis, renal, acute kidney injury, renal failure, neurological, altered consciousness, convulsions/seizures, encephalopathy, meningitis, cerebrovascular accident, hematological, disseminated intravascular coagulation, dermatological, chill blains, erythema multiforme, other (e.g. multisystem inflammatory syndrome (MIS)). Days from the SARS-CoV2 diagnosis it take before the SARS-CoV2 antigen test became negative was unknown. The patient underwent lab tests and procedures which included COVID testing: Positive on 09May2021, body temperature: 100 (fever that got up to 100) on an unspecified date in 2021. Only testing was initial COVID testing nothing post monoclonal antibodies. The patient received monoclonal antibodies as additional therapies for COVID-19 on 12May2021 same day results given. The events did not require the initiation of new medication or other treatment or procedure. The outcome of the events was recovered on an unspecified date in 2021.  Description of Product Complaint: Description of complaint: Fully vaccinated with COVID vaccine, first dose on 17Feb2021 with Lot: EL9266 and second dose on 10Mar2021 with Lot: EN6208 and tested positive for COVID virus on 09May2021.   Additional information has been requested.