Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Drug ineffective, Liver function test, Renal function test, SARS-CoV-2 test
Clinical narrative: a specialist went to her house on 24May2022 for the PCR testreceived the results on 27May2022; a specialist went to her house on 24May2022 for the PCR testreceived the results on 27May2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "a specialist went to her house on 24May2022 for the PCR testreceived the results on 27May2022". The patient underwent the following laboratory tests and procedures: Body temperature: 99.9, notes: Caller had a fever that went up to 99.9 but went back to 98.6; 98.6, notes: Caller had a fever that went up to 99.9 but went back to 98.6; Liver function test: 6.15; Renal function test: 6.05, notes: Renal elimination 6.05; SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: No PQC Present. PQC Details: Request Name: REQ-813218. Product was PAXLOVID. Question: 79y/o female patient called stating that she called last Wednesday about PAXLOVID. Caller stated that she went to a room and felt exposed to COVID on 20May2022 or 21May2022. Caller feels that a nurse or someone who had COVID went to that room. Caller stated that she started coughing at night , had a sneezing attack, and inflammation at night. Caller stated that she had been spitting up a lot of thick mucus which she described as "like a thick pudding". Caller had lost smell for about an hour. Caller had a fever that went up to 99.9 but went back to 98.6. Caller waited until 23May2022 to request for a test. Caller stated that a specialist went to her house on 24May2022 for the PCR test. Caller received the results on 27May2022. Caller called her doctor around 30May2022 or 01Jun2022 and was prescribed with PAXLOVID. Caller called on 01Jun2022 and was told that PAXLOVID stops replication of the virus and did not do anything to the mucus. Caller stated that she spoke to (Name withheld). Caller stated that after taking PAXLOVID, her sneezing has gotten better, but she still has congestion around the chest and mucus. Caller also stated that she has been able to walk pretty fast and carry heavy things. Caller wanted to confirm whether PAXLOVID can make the mucus thinner. Caller was told by her uncle who is a pharmacist about a combination of ciprofloxacin, moxifloxacin, and fluoroquinolone given to COVID patients. Caller was told that a study was done which showed that the medication targets the center of the virus. Caller asked if we have information on this. Informed caller that there is no information on this. Advised caller to consult with her doctor. Caller stated that she had 1 booster and 2 doses of the Pfizer COVID-19 Vaccine. Caller stated that she had the booster in Oct2021. Caller asked how long the drug would go out of the body and how long the virus would go out of the body. Caller asked when she will test negative from COVID. Caller stated that she had a scheduled test on 15Jun2022. Caller asked how long she should wait before getting tested. Caller asked about getting a monocloncal antibody and if she can get it. Caller wanted to confirm about taking PAXLOVID 5 days from having symptom. Caller asked if she had been off. Responded as per PI: 12 CLINICAL PHARMACOLOGY, 12.1 Mechanism of Action: Nirmatrelvir is a peptidomimetic inhibitor of the SARS-CoV-2 main protease (Mpro), also referred to as 3C-like protease (3CLpro) or nsp5 protease. Inhibition of SARS-CoV-2 Mpro renders it incapable of processing polyprotein precursors, preventing viral replication. LAB-1492-7.0. Revised: 14April2022. Advised caller to consult with doctor for other treatment recommendations for her. Call was remotely disconnected before survey was offered. Elimination, Major route of elimination, Half-life (t1/2) (hr), mean, Renal elimination 6.05, Hepatic metabolism 6.15. 1 EMERGENCY USE AUTHORIZATION: The Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of the unapproved product PAXLOVID for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, and who are at high risk1 for progression to severe COVID-19. 2 DOSAGE AND ADMINISTRATION, 2.1 Dosage for Emergency Use of PAXLOVID: Completion of the full 5-day treatment course and continued isolation in accordance with public health recommendations are important to maximize viral clearance and minimize transmission of SARS-CoV-2. Advised caller to consult with doctor for other treatment recommendations for her. Provided caller with hotline to CDC. Caller asked about getting a monocloncal antibody and if she can get it. Caller stated that we people did a wonderful job. Caller stated we were very helpful. These are positive things we've told her. Responded as per PI: 12 CLINICAL PHARMACOLOGY, Cross-resistance is not expected between nirmatrelvir and anti-SARS-CoV-2 monoclonal antibodies or remdesivir based on their different mechanisms of action. Advised caller to consult with doctor for other treatment recommendations for her. Caller stated we people did a wonderful job. Response: Acknowledged and thanked the caller. Caller stated that we were very helpful. These were positive things we've told her.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.