Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Liver function test, Pain, Pyrexia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: headache; chills; a temperature; body ache; a lot of head congestion; tiredness; Caller received vaccination with Pfizer primary series 06Jan2021 and 27Jan2021, now diagnosed COVID+; Caller received vaccination with Pfizer primary series 06Jan2021 and 27Jan2021, now diagnosed COVID+; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team and product quality group. The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administration date 27Jan2021 (Lot number: EL8982) at the age of 64 years as dose 2, single and administered in arm, administration date 06Jan2021 (Lot number: EK5730) as dose 1, single for covid-19 immunisation. Relevant medical history included: "cholesterol was a little high" (unspecified if ongoing); "kidney stones" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR taken for blood cholesterol increased (ongoing); ASPIRIN [ACETYLSALICYLIC ACID] (ongoing); HYDROCHLOROTHIAZIDE taken for nephrolithiasis (ongoing). The following information was reported: VACCINATION FAILURE (medically significant) with onset 08Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 08Jan2022, outcome "recovering" and all described as "Caller received vaccination with Pfizer primary series 06Jan2021 and 27Jan2021, now diagnosed COVID+"; HEADACHE (non-serious) with onset 09Jan2022, outcome "recovered" (Jan2022), described as "headache"; CHILLS (non-serious) with onset 09Jan2022, outcome "recovered" (Jan2022), described as "chills"; PYREXIA (non-serious) with onset 09Jan2022, outcome "recovered" (Jan2022), described as "a temperature"; PAIN (non-serious) with onset 09Jan2022, outcome "recovered" (Jan2022), described as "body ache"; CEREBRAL CONGESTION (non-serious) with onset 09Jan2022, outcome "recovering", described as "a lot of head congestion"; FATIGUE (non-serious) with onset 09Jan2022, outcome "recovering", described as "tiredness". The patient underwent the following laboratory tests and procedures: liver function test: (unspecified date) good, notes: she just had her annual physical and labs, like liver test and all those were good; sars-cov-2 test: (unspecified date) unknown results; (08Jan2022) positive. Therapeutic measures were taken as a result of covid-19, headache, chills, pyrexia, pain, cerebral congestion, fatigue.  Clinical course: The patient reported that the doses were given through hospital. The patient had a short test and the PCR test. She says the short test was the Quickvue SARS antigen FIA test and it was positive Saturday afternoon. She says she has not gotten the PCR test results yet, she is anticipating those will be there shortly, but she doesn't know the name of that. She says her illness has been not serious, she woke up feeling like a train wreck with chills, a temperature, body ache, and a lot of head congestion and headache on Sunday. She says she is feeling better now, her congestion and tiredness she would say are fairly mild. She says since she is 65 they put her on the Pfizer antiviral medication, when she was only two days into the illness, so she started her first dose on day two after being diagnosed, and took her second dose this morning, which is day three after diagnosis. She says she woke up with symptoms Saturday morning, which was the day before yesterday, so it has been 48 hours after, and she is feeling better. She was taking Crestor every other day, but she stopped taking that almost 36 hours before her first dose of Paxlovid since they suggested she not take it, coincidentally she is on the minimal dose and was already getting off it, it was the only thing they said would be contraindicated. She says she is also on low dose baby aspirin. She says she was taking the Crestor every other day, since she started the Paxlovid last evening she hasn't taken the Crestor. She says the Crestor came in an orange pharmacy bottle, and is actually the generic Crestor, 10mg. She has been taking it several years, the pharmacy label did not have LOT/EXP on it. She says the Crestor indication was her cholesterol was a little high, but it is much better controlled now so she was starting to wean off the Crestor. She says she also takes an 81mg baby aspirin daily, she has been taking this during COVID crisis since they recommended taking it. She says she also takes Hydrochlorothiazide 25mg, or HCTZ for short, one a day, but it is not for hypertension, it is to flush her kidneys out, she has a history of kidney stones. She says this medication was not contraindicated with taking Paxlovid, she has been taking it since about 10 years ago. Product Complaint: Caller who received the primary series of Pfizer COVID-19 vaccines and now has COVID. Pfizer COVID-19 vaccine NDC/EXP: Caller says these details were not provided for either dose on her typed vaccine card. She says she got her first dose 06Jan2021 of LOT: EK5730, and her second dose was given 27Jan2021 of LOT: EL8982. Caller says that they did a short test and the PCR test. She says the short test was the Quickvue SARS antigen FIA test and it was positive Saturday afternoon. She says she has not gotten the PCR test results yet, she is anticipating those will be there shortly, but she doesn't know the name of that. She says her illness has been not serious, she woke up feeling like a train wreck with chills, a temperature, body ache, and a lot of head congestion and headache on Sunday. She says she is feeling better now, her congestion and tiredness she would say are fairly mild. She says since she is 65 they put her on the Pfizer antiviral medication, when she was only two days into the illness, so she started her first dose on day two after being diagnosed, and took her second dose this morning, which is day three after diagnosis. She says she woke up with symptoms Saturday morning, which was the day before yesterday, so it has been 48 hours after, and she is feeling better.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events vaccination failure and covid19 cannot be totally excluded.