Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective
Clinical narrative: all Pfizer shots and third booster but not fourth booster; all Pfizer shots and third booster but not fourth booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 72-year-old male 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: "stents in heart" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "all Pfizer shots and third booster but not fourth booster". The patient underwent the following laboratory tests and procedures: Body temperature: (22Jul2022) 103, 103.5 maximum, notes: had a fever of 103, 103.5 maximum. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Caller states patient  was diagnosed with Covid four days ago, did not take Paxlovid, took Advil and Tylenol, and is now over Covid. Caller's 72-year-old husband got Covid the day after the caller's diagnosis, had a fever of 103, 103.5 maximum. Caller states she panicked, saw ad on TV, called husband's doctor to prescribe Paxlovid. Caller states her husband started taking Paxlovid the next day, had nausea, diarrhea, was tired and sleepy, couldn't function, started saying nonsense stuff", so yesterday the patient stopped taking the medication. Caller states husband is better again, has a low grade fever, he did have all Pfizer shots and third booster but not fourth booster. side effects are worse than what it (Covid) was. Caller states she was looking online, sees information stating do not stop taking Paxlovid. Caller states husband has taken only one sheet, two doses, has four sheets left.  Caller states now we're okay. Husband has stents in heart, is on blood thinner, takes cholesterol medication.  Caller asks husband during call how he is feeling and husband states he still has diarrhea.Report was not related to a study or program. Initial report type was selected and patient also the reporter. Other Conditions and Investigations was not provided. Covid 19 Vaccine a Pfizer product. And Pfizer is Covid 19 Vaccine manufacturer. NDC number of Covid 19 Vaccine was Not Provided. Expiry Date of Covid 19 Vaccine was not provided. Other products were not provided. Withheld states she has a consumer on the line calling about Paxlovid on behalf of her husband who is 72. Caller states the patient has had 2 doses, so 1 full day of medication. Patient started Paxlovid 1 day after Covid diagnosis. Caller reports the patient has had nausea, diarrhea, he is tired and sleepy, he could not function, and he was saying nonsense stuff. Caller states as of yesterday he stopped taking the medication. States the patient feels better although he still has a low-grade fever. Caller notes the patient has had all the Pfizer shots and the 3rd Booster but not the fourth booster. The caller was calling to find out about what happens if he stops taking the medication. She referred her to the patients HCP. Caller states they both got Covid, and she got it the day before he did. States she is 62 and he is 72. Caller states yesterday she was good and today she is 90% good. Caller states they eat the same thing and have been married for over 40 years. Caller states her husband has a stent in his heart. Caller states they have both had all of their shots up to the third booster, clarified 2 initial doses and one booster. Caller declines to complete a report. This is product complaint to report. Description of Product Complaint was reported as Tested positive for Covid 19 after receiving 3 doses of the Pfizer Covid 19 Vaccine. The patient finished one day and one night of Paxlovid and he has 4 tablet packs left. Caller states the patient took the first dose at night and then took a dose the next morning and a few hours later he was dizzy, sleepy, started having diarrhea and nausea and he didn't want to eat or drink anything. Caller states she told him to stop the medication because she was reading online those were side effects of the medication but then it also says don't stop the medication. Caller states that is why she is calling and she told the previous agent that since this is a new medication, her husband's doctor probably doesn't know much about it either so she wanted to contact Pfizer since they likely have more information about it. And she knows Covid can cause Diarrhea and sleepiness but the patient didn't' have those until he took Paxlovid. Caller asks call handler, is it okay for the patient to stop Paxlovid or should he continue Caller then asks, is it okay to stop this medication until tomorrow And then if he still continues to have the symptoms, they would know it is not a side effect from the Paxlovid, it would be from the Covid. Caller declines to complete a report, she states she thought this line could provide her with more information that she was looking for. Caller states she is going to call his physician and then maybe she will call back.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201015105 Same reporter, different patient/ drug/ AE;