Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, COVID-19, Headache, Illness
Clinical narrative: tested positive for COVID after COVID-19 Vaccinations; tested positive for COVID after COVID-19 Vaccinations; got sick; headache; sick to her stomach; felt weak; Lost some pounds; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 79-year-old female patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL8982, Expiration Date: 31May2021), on 18Feb2021 as dose 2, single (Lot number: EL9264, Expiration Date: May2021) and on 02Nov2021 as dose 3 (booster), single (Lot number: 32030BD) at the age of 79 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "cataracts removed", start date: 2004 (unspecified if ongoing), notes: had her cataracts removed; "Cholesterol" (unspecified if ongoing); "reflux" (unspecified if ongoing), notes: reflux; "Anemia" (unspecified if ongoing). Concomitant medication(s) included: ZETIA taken for blood cholesterol increased (ongoing); NEXIUM 24HR taken for gastrooesophageal reflux disease (ongoing); VITAMIN B12 [CYANOCOBALAMIN] (ongoing); VITAMIN C [ASCORBIC ACID] (ongoing); GERITOL [VITAMINS NOS] taken for anaemia (ongoing). Vaccination history included: First shingles shot (got her first shingles shot before her COVID-19 Vaccinations); Pneumonia (gets her Pneumonia and Flu Shot in October every year, got the Pneumonia and Flu Shot last year in October), administration date: Oct2021; Flu shot (Flu Shot, gets her Pneumonia and Flu Shot in October every year, got the Pneumonia and Flu Shot last year in October), administration date: Oct2021. The following information was reported: VACCINATION FAILURE (medically significant) with onset 14May2022 at 01:30, outcome "unknown", COVID-19 (medically significant) with onset 14May2022 at 01:30, outcome "recovered" (2022) and all described as "tested positive for COVID after COVID-19 Vaccinations"; ASTHENIA (non-serious) with onset May2022, outcome "recovered" (2022), described as "felt weak"; ILLNESS (non-serious) with onset May2022, outcome "recovered" (May2022), described as "got sick"; HEADACHE (non-serious) with onset May2022, outcome "recovered" (2022); ABDOMINAL DISCOMFORT (non-serious) with onset May2022, outcome "recovered" (2022), described as "sick to her stomach"; WEIGHT DECREASED (non-serious) with onset 2022, outcome "unknown", described as "Lost some pounds". The events "tested positive for covid after covid-19 vaccinations", "got sick", "headache", "sick to her stomach" and "felt weak" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14May2022) Positive, notes: Unit: Not Provided at 01:30 Am; (2022) Negative, notes: Thursday evening; Weight: (unspecified date) lost some pounds. Therapeutic measures were taken as a result of covid-19, illness, headache, abdominal discomfort, asthenia, weight decreased.  Tested positive for COVID after COVID-19 Vaccinations. Her teeth in the root of her gums felt like something was in the root of her teeth. Additional Information for Other medicines Zetia: She has been taking Zetia for a long time for her elevated cholesterol and can't take statin drugs. Additional Information for Other medicines Nexium: This is over the counter and has been taking 4-6 years. Additional Information for Other medicines Geritol: This is over the counter and is a multivitamin, multi mineral supplement. Dosage and Relevant Information for Preser Vision: : in morning and at night. Dosage text for Areds 2: 1 in the morning and 1 at night. Additional Information for Other medicines Hydroxine: She takes this as needed and knows she didn't take any last week or this week. Additional information: Caller was calling about the antiviral medication that she took for COVID. She asked how long after she finished the 5 day treatment and after COVID can she get her second booster shot. Caller stated the medication was Paxlovid. She stated she was fully vaccinated and had one booster of the COVID-19 Vaccine and wants to go ahead and get the second booster. Caller turned 80 years old last Monday. She stated over a month ago was when she got COVID and went to the Emergency Room and tested positive and was given the antiviral for 5 days. Tested positive for COVID after COVID-19 Vaccinations: Caller stated Mother's day was 08May and she tested positive on Saturday morning, 14May2022, at 1:30am in the emergency room. She was not admitted to the hospital. She really thinks she got sick was because she didn't have the second COVID-19 Vaccine booster dose. She didn't have a high fever just a headache, sick to her stomach and felt weak and this is why she went to the emergency room. She knows she was exposed to COVID because she went to a neighbor's house after a passing of a neighbor and everyone in that house tested positive. She and her son tested Thursday evening but was negative but she got sick on Friday morning with a terrible headache. She went to the emergency room. Seriousness: She states her pre vaccination and booster was what kept her from being admitted to the hospital. Outcome: She recovered completely. She stated she wasn't sick after the first day and felt good after 2 or 3 days. Her teeth in the root of her gums felt like something was in the root of her teeth: She had a side effect from the Paxlovid which was her teeth in the root of her gums felt like something was in the root of her teeth. She knows nothing was there because she brushes her teeth everyday and flosses after every meal. She had this feeling well after she stopped taking the Paxlovid. She also mentioned her 2 front teeth are a little loose and her teeth weren't like that before the Paxlovid. Product Details: She put the Paxlovid in the trash after she finished the Paxlovid. Dose: 6 pills a day; She doesn't know the milligrams but took 3 in the morning and 3 at night. She took the Paxlovid at 9am and 9pm because she is a retired Registered nurse. Received her 1st and 2nd dose of the COVID-19 Vaccine at withheld. Received at withheld.She mainly takes vitamins and cholesterol medication every day. She takes over the counter eye drops too as a lubricant for her dry eyes. She had intraocular lens as she had her cataracts removed in 2004. The eye drops are daily for dry eyes. She was not taking any blood pressure medication and hasn't taken any blood pressure medication in over a year. She lost some pounds when she was sick with COVID and is hoping to keep the pounds off. She exercises daily and turned 80 years old Monday. Anatomical Location of Administration of Pfizer vaccine considered as suspect: In her arm; Left deltoid usually as that is her non-dominant arm. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): No; She needs her next shingles shot because she got her first shingles shot before her COVID-19 Vaccinations. She gets her Pneumonia and Flu Shot in October every year and got the Pneumonia and Flu Shot last year in October. AE(s) following prior vaccinations: None. Patient's Medical History (including any illness at time of vaccination): None. Family Medical History Relevant to AE(s): No. Relevant Tests: None. Is there a product complaint to report: Yes. Description of Product Complaint: Description of complaint: She is fully vaccinated and had one booster of the COVID-19 Vaccine. She tested positive on Saturday morning, 14May2022, at 1:30am in the emergency room. Packaging sealed and intact: For her booster dose the technician or pharmacist had already drawn up the vaccine in the syringe.; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded.