Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthrough COVID-19/she had all four Covid Shots; Breakthrough COVID-19/she had all four Covid Shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL3247), on 08Feb2021 as dose 2, single (Lot number: EL3302), on 21Sep2021 as dose 3 (booster), single (Lot number: 30135BA, Expiration Date: 30Nov2021) and on 13Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing); "she remembers having a hard time breathing", start date: 1994 (unspecified if ongoing); "she couldn't drive" (unspecified if ongoing); "She was covered in welts", start date: 1994 (unspecified if ongoing); "her brain was swollen", start date: 1994 (unspecified if ongoing), notes: her brain was swollen. Concomitant medication(s) included: WELLBUTRIN taken for depression, start date: 1999. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Jun2022, outcome "unknown" and all described as "Breakthrough COVID-19/she had all four Covid Shots". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jun2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Reporter stated that she had a severe reaction to Paxlovid. She took the first dose in the early evening on 17Jun2022. She woke up unable to breathe around 0200 on 18Jun2022. She went by ambulance and was hospitalized. Patient tested positive for COVID-19 on 17Jun2022 and was prescribed the Paxlovid.  She took her first dose that evening and she took the morning dose at the hospital on 18Jun2022. She had no reaction after taking the morning dose on 18Jun2022. It was stated that patient started reading up on side effects and decided that it was the Paxlovid that made her throat swell. Patient states that she doesn't remember going to the hospital or the ambulance; she doesn't remember anything and thinks that is weird. She only remembers not being able to breathe. patient stated that she doesn't even know what they did at the hospital. Patient stated that her discharge paperwork does not give her primary diagnosis. Patient stated that the only other medication she had a severe reaction to was Wellbutrin that she was taking for depression years ago. Patient also mentions she has had all four COVID shots, so this was a breakthrough of COVID. Patient states that when she was admitted to the hospital she weighed 130 pounds, but she has lost a few pounds over the last few weeks. It was reported that difficulty breathing, covered with welts, Brain was swollen patient states that she remembers this after she took Wellbutrin for depression. Patient states that her son was 11-year-old at the time, so it had to be in 1994.  Patient states that she remembers having a hard time breathing and she couldn't drive, she didn't call anyone she just went to bed.  The next morning she woke up and took her son to school, then went to an urgent care type facility. They could not believe she drove herself there. She got three epinephrine shots. She was covered in welts. She got an unspecified steroid pack from the doctors office and that didn't help, she still had problems.  She got a second unspecified steroid pack and that made it much better.  Patient states that the doctor told her that her brain was swollen. It was reported that no other medications, medical conditions, labs, testing, or treatments relevant to these events. Patient states they gave her an unspecified IV antibiotic in the hospital, and that was all that she knows.