Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Spinal disorder, Vaccination failure
Clinical narrative: were fully vaccinated with the Pfizer vaccines all six (Pfizer COVID-19 Vaccine) of them including the one in SeptemberPCR tests came positive for me; were fully vaccinated with the Pfizer vaccines all six (Pfizer COVID-19 Vaccine) of them including the one in SeptemberPCR tests came positive for me; had very serious cervical spine surgery; This is a spontaneous report received from a Consumer or other non HCP.  A 70-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing), notes: controlled; "I have complex auto immune disorders (History)" (ongoing). Concomitant medication(s) included: SYNTHROID; DIOVAN taken for hypertension. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 01Apr2021, when the patient was 68-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE), administration date: 22Apr2021, when the patient was 68-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: 09Sep2021, when the patient was 68-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE), administration date: 05May2022, when the patient was 69-year-old, for COVID-19 immunization; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE), administration date: 26Oct2022, when the patient was 69-year-old, for COVID-19 immunization. The following information was reported: SPINAL DISORDER (medically significant) with onset 23Oct2023, outcome "unknown", described as "had very serious cervical spine surgery"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "were fully vaccinated with the Pfizer vaccines all six (Pfizer COVID-19 Vaccine) of them including the one in SeptemberPCR tests came positive for me". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2023) Negative, notes: until three or four days into my symptoms; (Dec2023) Positive, notes: and I came up positive the same time. Therapeutic measures were taken as a result of vaccination failure, covid-19 (as Paxlovid from 15Dec2023), spinal disorder. Clinical Course: Consumer stated she and her husband both were fully vaccinated with the Pfizer vaccines all six (Pfizer COVID-19 Vaccine) of them including the one in Sept. She do not come down with Covid positive until it was Wednesday night, Thursday morning or maybe Thursday, it would have been Thursday morning, Thursday night before the rapid as well as the PCR tests came positive for her. Her earlier symptoms were very mild. She had no fever her kind of mimicked, an allergy or a sinusitis attack and it was very mild. She was already with hypertension For some reason my antibodies were much stronger and higher in number than my husband were. 8 weeks ago she had very serious cervical spine surgery. She had specially the hypertension she was already hypertensive but controlled by. When paraphrased the concern: Consumer stated, "Yes, she had on 23Oct, she had cervical surgery for 4 hours in (withheld). Medication Name for Hypertension: Consumer stated, she was taking the Diovan. She had to stop her regular meds (Later clarified as Diazepam, Oxycodone and Acetaminophen) for the cervical spine surgery because of the Paxlovid interactions. Weight: Consumer stated, her weight was being fluctuating since surgery but can put probably 114. Other medical conditions and concomitant medications: Consumer stated, she took Synthroid, have been taking for do not know, 20 years, maybe more. Diovan: Consumer stated, she take Diovan 40 milligrams, twice a day.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.