Received Jun 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
covid; covid/bad cough, secretions, nasal drippings; This is a spontaneous report received from a Physician from medical information team, Program ID. An 82-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cardiac disease" (unspecified if ongoing); "coronary artery disease" (unspecified if ongoing); "valvular artery disease" (unspecified if ongoing); "heart failure" (unspecified if ongoing); "atrial fibrillation" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "renal induced gout" (unspecified if ongoing); "Blood thinner" (unspecified if ongoing); "Kidney failure" (unspecified if ongoing); "Hypercholesterolemia" (unspecified if ongoing); "Blood pressure high" (unspecified if ongoing); "airways disease" (unspecified if ongoing), notes: always before exercise and it is for airway disease. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus; FEBUXOSTAT taken for gout; APIXABAN taken for anticoagulant therapy; LASIX [FUROSEMIDE] taken for renal failure; ATORVASTATIN taken for hypercholesterolaemia; LISINOPRIL taken for hypertension; FARXIGA; LEVALBUTEROL [LEVOSALBUTAMOL] taken for bronchial hyperreactivity. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered", described as "covid"; COVID-19 (medically significant), outcome "not recovered", described as "covid/bad cough, secretions, nasal drippings". The patient underwent the following laboratory tests and procedures: Blood test: Unknown results; Flu A: Unknown results; Unknown results; Respiratory syncytial virus test: Unknown results; SARS-CoV-2 test: Positive, notes: 3rd or 4th day tested; Positive, notes: 3rd or 4th day tested. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course : The caller is retired doctor, calling in to ask why they only got 5 days for taking the Paxlovid. Wanted to know the typical reaction for it and also had a shot for Pfizer Covid-19 vaccine but there was a case that he had a bad cough, had secretions and nasal drippings. Got better almost immediately for 3-5 days and on the 5th they stopped taking it and came back in spades and much worse than the beginning. As per transferring agent caller is a patient in this situation but caller is also a retired physician, transferring agent provided HCP contact information verbally per HCP (both him and his wife) came down with covid, 3rd or 4th day tested positive day were put on Paxlovid (both him and his wife) and symptoms went absolutely away progressively 5 days when they were on it, nasal drainage was much less, and it was putrid and coughing started to clear quite a bit after 5th day it was like a reticence of the disease and it was worse that we have ever had and next 2 or 3 days it was progressively worse and worse and worse we are now week after that and we seem to be doing well how many people get a rebound. The caller is a retired university doctor professor and a patient, took a course of Paxlovid and first time had Covid since the beginning of the year. They got a good dose about 3-4 days into it. Wanted to know if that is a typical reaction had a bad cough, had secretions in his nasal drippings and took it. He got better almost immediately and was incredible for about 3-5 days. They stopped taking it on the 5th day and disease came back in spades and much worse than in the beginning. He's also fully vaccinated and was a Pfizer vaccine and got worse because of Paxlovid, awful taste in his mouth and wanted to talk with somebody as to why they only get 5 days.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 omicron (kp.2) cannot be excluded for the reported LOE events.
Medical History/Concurrent Conditions: Anticoagulant therapy; Atrial fibrillation; Blood pressure high; Cardiac disorder; Combined valvular disease; Coronary artery disease; Diabetes; Gout; Heart failure; Hypercholesterolemia; Kidney failure; Reactive airways disease (always before exercise and it is for airway disease)
METFORMIN; FEBUXOSTAT; APIXABAN; LASIX [FUROSEMIDE]; ATORVASTATIN; LISINOPRIL; FARXIGA; LEVALBUTEROL [LEVOSALBUTAMOL]
Test Name: blood work; Result Unstructured Data: Test Result:Unknown results; Test Name: Flu A; Result Unstructured Data: Test Result:Unknown results; Test Name: Flu B; Result Unstructured Data: Test Result:Unknown results; Test Name: Respiratory Syncytial Virus; Result Unstructured Data: Test Result:Unknown results; Test Name: Covid-19; Test Result: Positive ; Comments: 3rd or 4th day tested; Test Name: Covid-19; Test Result: Positive ; Comments: 3rd or 4th day tested