Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested + on 22Jul; Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Jan2021 as dose 1, single (Lot number: EK9231), in left arm, on 05Feb2021 as dose 2, single (Lot number: EL3247), in left arm, on 30Aug2021 as dose 3 (booster), single (Lot number: EW1087), in left arm and on 08Feb2022 as dose 4 (booster), single (Lot number: FJ5682) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Complex regional pain syndrome" (unspecified if ongoing); "s/p lyme disease" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: contrast iodine" (unspecified if ongoing); "known allergies: nightshade allergy" (unspecified if ongoing), notes: known allergies: nightshade allergy. Concomitant medication(s) included: OXYCODONE, start date: Jan2011; TRAZODONE, start date: Jan2011, stop date: 13Jul2022; ESTRADIOL, start date: Sep2001, stop date: 16Jul2022; ACYCLOVIR [ACICLOVIR], start date: Feb2009, stop date: 16Jul2022; ADDERALL, start date: 13Jun2022, stop date: 14Jul2022. Past drug history included: Morphiene, reaction(s): "Known allergies: Morphine"; Ativan, reaction(s): "adverse response", notes: adverse response to ativan & gabapentin; Gabapentin, reaction(s): "adverse response", notes: adverse response to ativan & gabapentin; Ativan, reaction(s): "Known allergies: Ativan", notes: adverse response to ativan & gabapentin; Gabapentin, reaction(s): "Known allergies: Gabapentin", notes: adverse response to ativan & gabapentin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Jul2022, outcome "recovered" (19Jul2022) and all described as "Covid-19"; DISEASE RECURRENCE (medically significant) with onset 22Jul2022, outcome "recovered" (27Jul2022), described as "tested + on 22Jul". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jul2022) Positive, notes: Initially tested + on PCR 14Jul; (19Jul2022) Negative, notes: Tested - on 19Jul; (22Jul2022) Positive, notes: tested + on 22Jul and 25Jul; (25Jul2022) Positive, notes: tested + on 22Jul and 25Jul; (27Jul2022) Negative, notes: Tested - on 27Jul. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Other medication received in 2 weeks. Paxlovid received as a treatment. Treatment Indication: Treatment of COVID-19. Adverse event: Had strong, bad taste, slight dizziness within 30 minutes of first dose. This waned after about 10 hrs. Worse side effects with 2nd dose plus nausea. Covid Sx of mild sore throat, tight chest & low O2 greatly improved. Mostly feeling the medication effects. Nausea slightly better after 11 hrs. 3rd dose had significant dizziness, nausea and bad taste plus vomiting. Unable to tolerate another dose and discontinued with PCP consult. It took two days for side effects to improve. Still have some fuzzy headedness. Initially tested + on PCR 14Jul. Tested - on 19Jul. Slight return of sniffles & tested + on 22Jul and 25Jul. Tested - on 27Jul. Started having chest pain and diaphragmatic spasms on 26Jul which has continued. O2 sat are normal. Still feeling mild nausea and GI discomfort. I may have better tolerated a lower dose better? I weigh 137 lbs. Every person I know of that has taken Paxlovid has had a rebound but have not reported it to my knowledge. Likely this is under reported.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of covid-19 and vaccination failure.