Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid today; tested positive for Covid today; 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 62-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing), notes: I am on two and half milligram Amlodipine for hypertension (Intent: History). The patient's concomitant medications were not reported. Past drug history included: Ondansetron, reaction(s): "I am allergic to four drugs", notes: I am allergic to four drugs, swollen tongue; Methergine, reaction(s): "I am allergic to four drugs", notes: I am allergic to four drugs, she developed rashy, itchy arms.; Oxycodone, reaction(s): "I am allergic to four drugs", notes: I am allergic to four drugs, she developed rashy, itchy arms.; Azo-gantrisin, reaction(s): "Drug allergy", notes: I am allergic to four drugs., one and the last one is Azo Gantrisin but that been taking two years ago. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02May2022, outcome "unknown" and all described as "tested positive for Covid today". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02May2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.   It was reported that Caller, female, aged 62, tested positive for Covid today and started developing symptoms last night. She has been prescribed Paxlovid. Initiate PAXLOVID treatment as soon as possible after diagnosis of COVID-19 and within 5 days of symptom onset. She is currently taking 2.5mg amlodipine and is allergic to four medications: ondansetron, methergine, oxycodone with acetaminophen although she can tolerate acetaminophen by itself, and Azo Gantrisin which she believes has since been discontinued. She is most allergic to ondansetron and that is the medication she is most concerned about. She developed a swollen tongue from that, it swole so much. With the metherine and oxycodone/acetaminophen she developed rashy, itchy arms. She's been taking tylenol for this terrible headache and she's been taking tylenol for years. The tylenol is barely taking her fever down right now though. Her fever was at 101F but is now down to 100F, but even after two hours it didn't go away. She has also had the third dose of the vaccine, the Pfizer booster. She has been going back and forth on whether or not to take the Paxlovid. She knows its not FDA approved but is concerned about the longer she doesn't take it. She doesn't want to feel like this- headaches, body aches and fever but she also is concerned about developing an allergic reaction. She started developing symptoms last night around midnight, so she states she has time if she wants to wait a couple days and see if it resolves without taking the Paxlovid. Upon Follow-up Additional Context: Concern: Consumer stated, "I took the home covid test and I am positive called my doctor and she prescribed Paxlovid because I am on two and half milligram Amlodipine for hypertension (Intent: History). But I called because I am allergic to four drugs and wanted to make sure it is no possibility if I take this I might be allergic to Paxlovid. Can I tell the names of 4 drugs? I am already on Ondansetron, Methergine, Oxycodone/Acetaminophen but I do take Acetaminophen but not the Oxycodone (hence, acetaminophen captured as suspect) one and the last one is Azo Gantrisin but that been taking two years ago." (Further not clarified appropriately if consumer has started consuming Paxlovid hence, Paxlovid captured as suspect) Consumer was informed about the role of Pfizer Drug Safety. When requested to probe further: Consumer stated, "Is it required? Because right now really I have bad headache and body ache." Consumer was unwilling to complete the report. Further probing could not be done. Hence, limited information available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.