Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Investigation, SARS-CoV-2 test
Clinical narrative: received 2 doses of the Pfizer COVID-19 vaccine and tested positive for COVID; received 2 doses of the Pfizer COVID-19 vaccine and tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient received BNT162b2 (BNT162B2), in Jun2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 13Jul2021 at 16:00 as dose 2, single (Batch/Lot number: unknown) at the age of 40 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14Jun2022, outcome "recovering" and all described as "received 2 doses of the Pfizer COVID-19 vaccine and tested positive for COVID". The events "received 2 doses of the pfizer covid-19 vaccine and tested positive for covid" required emergency room visit. The patient underwent the following laboratory tests and procedures: swabbed for flu: (unspecified date) Negative, notes: negative for flu; SARS-CoV-2 test: (14Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: On 14Jun2022 Paxlovid was taken as treatment drug for COVID (Batch/lot number GA5109) in pills form. Yes, the patient is also the reporter. Yes, the paxlovid was a Pfizer product. NDC number of Paxlovid: 0069-1085-30, Expiry Date of Paxlovid: Feb2023. Yes COVID-19 vaccine was a Pfizer product. Caller was calling about Paxlovid, the 5 day regimen for COVID-19. Caller had a question, caller was on the 4th day of the medication today, caller took the morning dose around 9AM and has been feeling better since yesterday, but was wondering if there are any bad side effects if call drinks alcohol tonight. Caller confirmed she had not had any alcohol yet, wanted to ask Pfizer, because caller knows that her doctor will say don't do it because caller had one more dose tonight and one more dose to take in the morning. Caller was feeling 100% better and has a gathering to go to tonight and took a test and was fine, caller was wondering if she can stop the medication or if caller needs to continue the medication?. Caller got 2 COVID shots awhile back, confirms she was referring to the Pfizer COVID-19 vaccine, caller got diagnosed awhile back with COVID at the emergency room on 14Jun2022. Caller confirms she was not admitted to the hospital, just had a swab test and was given the Paxlovid. Dose, route, frequency: Says 300mg-100mg, because one pill, ritonavir, was 100mg, and then there are 2 nirmatrelvir which are 150mg, by mouth, take one dose in the morning and one dose in the evening, 3 pills for each dose. Initially caller stated no, then while filling out the vaccine supplemental form caller stated that she just has GERD and anxiety. Tests: Caller was just swabbed for COVID and the flu, the flu was negative and COVID was positive. No, Vaccination administered was not at certain Facility. No, all vaccines administered on same date with the Pfizer vaccine considered as suspect hasn't gone for booster, was kind of nervous to get booster, should had gotten the booster. Caller went to the Emergency Room, was not admitted to the hospital, was swabbed for COVID and flu, positive for COVID, negative for flu. Given Paxlovid. Caller just had a sore throat, fever, chills, no breathing problems, thought it was strep or allergies. Caller works at a nursing home and there are a lot of people sick there, that is probably how she got COVID. No, other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Yes, there was a product complaint to report. Received 2 doses of the Pfizer COVID-19 vaccine and tested positive for COVID. NDC numbers, lot numbers, expiration dates: Unknown, caller did not have the information at the time of the call.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.