Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I picked up COVID; picked up BA5; I am boosted with Pfizer's shots; I picked up COVID; picked up BA5; I am boosted with Pfizer's shots; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, 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), COVID-19 (medically significant), outcome "unknown" and all described as "I picked up COVID; picked up BA5; I am boosted with Pfizer's shots". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical information: Consumer stated, no just wanted to share their experience to help guys absolutely. Patient do not see directly, dont work in that capacity. Patient was 100 percent mask compliance and just went to the airport with their kids on vacation and picked up BA5. Patient boosted with Pfizers shots (name of the shot could not be clarified over call hence suspect captured as Unspecified Shot conservatively) which was a huge fan and by the way as soon as patient get better the first thing and was going to do get the new Bivalent COVID Vaccine because patient have read and understand that, that one addresses the later lineages of Omicron and of course BA5, BA4, .5, .6 and Centaurus BA2.75, you know those, you know all three of those? Consumer stated, they dont have much time so, we are going to do this my way. Patient going to tell experience with Paxlovid and then was going to end the call. Okay so, here was what happened. Patient picked up COVID and decided on Wednesday to get Paxlovid, started at Wednesday night. If the call was recorded just listen to this recording. Wednesday night took it, immediately had the metallic taste in mouth which they told me about that said, you know you are going to have most likely some have the metallic taste. It was not an issue enjoyed you know, no big deal, did not affect their appetite, was still able to eat, still wanted food but it was immediate that had the taste in the mouth so, knew that was an issue right away. Then patient had diarrhea for the first two days of treatment and then that changed and that went away but the reason that am calling you guys was, because last night and the day before their voice went hoarse and that was dangerous. Patient lips and gums were somewhat swollen it was difficult to feel what was happening inside mouth because of the taste. Dont know that was able to feel what exactly was happening in mouth, but as yesterday continued patient called the emergency room about this because of voice, when you have a hoarse voice, that was a red flag that could mean that patient having a dangerous allergic reaction to it so, knew that. Patient researched everything clearly know more about the COVID strains than you do which was upsetting. You guys should be an expert on every strain of COVID, you should have known exactly what patient was talking about step by step. Patient dont see how did not or do you, are you an expert on COVID I mean, you have to be, right? Consumer was again informed about the role of Pfizer Drug Safety Department. Consumer stated, you got some kind of medical background in order to make cogent sense out of what am saying, there was no way you have no medical background. So, late last night patient called the emergency room because this thing was starting to make voice go more and more and more then and having trouble breathing so, patient decided to stop taking Paxlovid at day 4 of it because the taste in mouth and because of the experience of it, was that clear enough, see you later.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events drug ineffective  and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.