Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EM9810), in arm, on 25Mar2021 as dose 2, single (Lot number: ER2613), in arm, on 05Nov2021 as dose 3 (booster), single (Lot number: FH8020), in arm and on 12May2022 at 13:00 as dose 4 (booster), single (Lot number: FK9729) at the age of 73 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (ongoing), notes: High blood pressure Diagnosed for 20 years; "High cholesterol" (ongoing), notes: High cholesterol Sort of has high cholesterol.States it wasn't really high,she had a stressful job. Had high cholesterol for the last 10 years. "Arthritis" (unspecified if ongoing), notes: Arthritis Diagnosed for last 5 years. It's been bothering her. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation as dose number unknown, single; LISINOPRIL taken for hypertension; SIMVASTATIN taken for blood cholesterol increased. Vaccination history included: Cortisone shot (Had a Cortisone shot to the right knee in Feb2022, before getting COVID-19.), for Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Jun2022, outcome "recovered" (15Jul2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 101 degrees; SARS-CoV-2 test: (30Jun2022) positive, notes: Clarified she tested positive for COVID-19 on 30Jun2022; (15Jul2022) negative, notes: Went to hospital, got a COVID-19 test there and was told her PCR was negative; (14Jul2022) positive, notes: She came home on 14Jul2022 and was positive on a rapid COVID-19 test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Caller got COVID-19 on 29Jun2022 and was COVID-19 negative 15Jul2022. Positive with the PCR test. Was inquiring about getting booster dose of Pfizer COVID-19 Vaccine. Her previous COVID-19 Vaccine doses were manufactured by Pfizer. Attempted to clarify details provided by the transfer agent, but caller began speaking over this DSU agent. The patient reported that she came home on 14Jul2022 and was positive on a rapid COVID-19 test. Went to hospital, got a COVID-19 test there and was told her PCR was negative, that she probably just had COVID-19 in her system but is not contagious at this point. Offered transfer to MI for her questions, but stated transfer agent addressed her questions advising her it's up to her if she feels comfortable to receive the COVID-19 Vaccine booster today. Her second COVID-19 Vaccine booster was 12May2022 and didn't get sick until 29Jun2022. She got COVID-19 on the plane ride, she went out of the country. Didn't have a fever until day she arrived. If airlines still had the rule in place about getting tested before she flew, probably would have known she was positive. Everyone wore masks was feeling fine. Clarifies it wasn't until she arrived at her destination on 30Jun2022 she felt she had fever. Clarified she tested positive for COVID-19 on 30Jun2022 when she arrived. Saw her doctor in Aug2022 or Sep2022, letting her doctor know she had COVID-19. States she didn't have any adverse reaction to the COVID-19. She had a fever for 2 days, but it was also 101 degrees. Hard to differentiate if it was the fever or the heat outside. Rapid test at home on 14Jul2022 when she arrived back home was positive. Went to the hospital just for a COVID-19 test and the PCR was negative. She reported that all of her friend she went on the trip with tested negative for COVID-19 on 09Jul2022. She traveled with 8 other people.Caller had ran out of rapid COVID-19 tests, but when she came home, was able to take a rapid test. She was the only 1 out of 8 that was COVID-19 positive. Had a cough that lasted a month, until end of Jul2022, had no other adverse reactions to the COVID-19. The same day as each of her Pfizer COVID-19 Vaccines, she took Tylenol three hours after the vaccine administration. She does this with any vaccine she gets. Tylenol:Dose: 500mg just once.Formulation: blue and red 250mg each capsule, Date Administered: Same day as each of her COVID-19 Vaccines.Time of Use: 3 hours after vaccine administration. History and Investigations: Given a gel injection for her right knee after she was negative for COVID-19. It had nothing to do with COVID-19. Had a Cortisone shot to the right knee in Feb2022, before getting COVID-19. Her right knee has been giving her problems. Bought cough medicine and aspirin 500mg when she arrived. The patient did not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) and did not had any AE(s). Just took the Flu shot 03Oct2022. She just has an ache to the arm and maybe a slight fever to other vaccines, but does not provide any product names. States she has taken many vaccinations as she travels a lot. Has never gotten really sick. The 8 of them just stayed to themselves. Five people in their group didn't have the same reaction from COVID-19 as caller and her friend had. The five people had a light cough, but didn't get a fever.Caller and 2 others got a fever and cough with their COVID-19. The 5 people were also taking something for COVID-19, clarified as extract of Oregano, which boosts the immune system. Caller had two days and two nights of fever. The five other friends had cough, a slight achiness in the body, which started on 03Jul2022. These five friends didn't get the severity that caller and the other two friends had. Caller met her five friends on 01Jul2022 and they didn't get sick until 03Jul2022. Caller states she is assuming these 5 friends were positive for COVID-19, however, they did not take a COVID-19 test. All of them were better within 5 days after. Caller and her two friends were better by the 4th day, they were fine. The five other friends were better 5 days after they initially got sick. Patient experienced COUGH (non-serious) with onset 30Jun2022, outcome "recovered" (Jul2022); PYREXIA (non-serious) with onset 30Jun2022, outcome "recovering", described as "fever".   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201240143 Same patient and drug, different event separated in time;