Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jan2021 at 17:00 as dose 1, single (Lot number: EL1284), in left arm, on 26Jan2021 at 17:00 as dose 2, single (Lot number: EL3246), in left arm, on 09Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FE2590), in left arm and on 04Apr2022 at 18:00 as dose 4 (booster), single (Lot number: FF9894) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "other medical history: Glaucoma" (unspecified if ongoing), notes: other medical history: Glaucoma and insomnia. Anxiety; "other medical history: insomnia" (unspecified if ongoing), notes: other medical history: Glaucoma and insomnia. Anxiety; "other medical history: Anxiety" (unspecified if ongoing), notes: other medical history: Glaucoma and insomnia. Anxiety; "known allergies: Gluten" (unspecified if ongoing), notes: known allergies: Gluten and milk; "known allergies: milk" (unspecified if ongoing), notes: known allergies: Gluten and milk; "Glaucoma med" (unspecified if ongoing). Concomitant medication(s) included: MIRTAZAPINE, start date: 01Mar2021 (ongoing); AMBIEN, start date: 01Jul2018 (ongoing); TIMOLOL taken for glaucoma, start date: 01Dec2019 (ongoing); BENTYL, start date: 21Mar2022 (ongoing); TYLENOL, start date: 04May2022, stop date: 07May2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 100.2 max, notes: temp 100.2 max; (unspecified date) 100.9, notes: Tylenol and ibuprofen together can bring temp down to 100 .9; (11May2022) 103.2, notes: chills/fever 103.2; SARS-CoV-2 test: (unspecified date) Positive, notes: tested positive with the rebound; (unspecified date) Negative, notes: I did test negative after finishing paxlovid; (03May2022) Positive, notes: Tested positive on 03May2022; (11May2022) Positive, notes: I did test negative after finishing paxlovid but then tested positive with the rebound. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid started on 04May2022 ended on 08May2022.  Clinical course: Husband tested positive 02May. They both had runny nose, sore throat temp 100.2 max. Tested positive on 03May2022. Started the paxlovid 04May and felt only minor head cold symptoms at end of day 08May. then the rebound 11May2022 3:00am chills/fever 103.2. Only Tylenol and ibuprofen together can bring temp down to 100 .9. Grinding migraine headache, horrible constant runny nose, can hardly swallow sore throat, chest congestion and tightness when coughing. Very sick w high fever for 3 days. 10 days out most symptoms resolved but taste is weird, metallic, food unappealing. Exhausted by minimal exertion. Husband came thru fine after 5 day course. She feel mentally foggy trying to remember something or simple math calculations. She had slowly increase exercising by walking 1 mile and rowing machine 20 minutes. After being up for 2 hrs she need to lay down and rest. The rebound was so much worse than first positive test. She did test negative after finishing paxlovid but then tested positive with the rebound.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Vaccination failure and Covid 19 and the role of suspect drug cannot be ruled out. The case will be reassessed once new information is available.