Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech.; product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech.; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group.  A 90-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Jan2021 as dose 1, single (Lot number: EK4176), on 05Feb2021 as dose 2, single (Lot number: EL9264) and on 27Sep2021 as dose 3 (booster), single (Lot number: EW0170) at the age of 89 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 03May2022 as dose 4 (booster), single (Lot number: 057M21A) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "adhesive capsulitis of the shoulder" (unspecified if ongoing); "carotid stenosis" (unspecified if ongoing); "cervical radiculitis" (unspecified if ongoing); "chronic sinusitis" (unspecified if ongoing); "HTN" (unspecified if ongoing); "GERD" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing); "idiopathic progressive polyneuropathy" (unspecified if ongoing); "lumbar radiculopathy" (unspecified if ongoing); "peripheral arterial occlusive disease" (unspecified if ongoing); "lumbar radi" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN ER oral, start date: 28Feb2020; METOPROLOL oral, start date: 29Jan2018; OMEPRAZOLE, start date: 06Mar2018; ROSUVASTATIN oral, start date: 20Feb2020; ZOLPIDEM, start date: 23Jan2018; OXYCODONE, start date: 29Aug2018. Past drug history included: Amitriptyline, reaction(s): "Allergy"; Bactrim, reaction(s): "Allergy"; Cymbalta, reaction(s): "Allergy"; Gabapentin, reaction(s): "Allergy"; Lisinopril, reaction(s): "Allergy"; Mybetric, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 31May2022, outcome "not recovered" and all described as "product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31May2022) Positive; (08Jun2022) Negative; (13Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received other medication in 2 weeks. Rebound Covid 19 after treatment with Paxlovid, tested positive for covid and start of sx on 31May2022; treated with Paxlovid starting evening of 31May2022; completed 5 day series on morning of 06Jun2022; felt better tested negative for Covid 19 by OTC method on 08Jun then Friday 10Jun patient redeveloped fever, congestion and cough, retested with OTC Covid test 13Jun2022 and again positive for Covid. The adverse event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to vaccination failure and COVID-19 cannot be ruled out.