Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site swelling, Lethargy, Pyrexia, Tinnitus, Urticaria
Clinical narrative: COVID-19/Covid-19 test positive; COVID-19/Covid-19 test positive; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 29Jan2021 at 08:30 as dose 1, single (Lot number: EL0142), in right arm, on 19Feb2021 at 08:30 as dose 2, single (Lot number: EL926), in right arm and on 29Jun2022 at 10:30 as dose 3 (booster), single (Lot number: FJ4991) at the age of 71 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Migraine", start date: 2004 (ongoing); "Asthma", start date: 1980 (ongoing); "Takotsubo", start date: 2014 (ongoing), notes: Illness/AE: Takotsubo; "Cardiac spasm" (ongoing), notes: Illness/AE: Cardiac spasm; "Hiatal hernia with GERD", start date: 2019 (ongoing), notes: Hiatal hernia with GERD, Pertinent details: Had LINX surgery; "Fibromyalgia", start date: 1999 (ongoing); "Osteopenia/ perosis with joint pain" (ongoing), notes: Osteopenia/ perosis with joint pain; "Osteopenia/ perosis with joint pain" (ongoing), notes: Osteopenia/ perosis with joint pain; "Allergy" (unspecified if ongoing); "Leg cramps" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "sleep" (unspecified if ongoing), notes: sleep; "Blood pressure" (unspecified if ongoing); "constipation" (unspecified if ongoing); "Brain fog" (unspecified if ongoing); "Prevent bladder infections" (unspecified if ongoing); "Low vit-D" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Overactive bladder" (unspecified if ongoing); "Heart" (unspecified if ongoing), notes: Heart; "Prevent bladder infections" (unspecified if ongoing), notes: Prevent bladder infections; "Hiatal hernia with GERD", start date: 2019 (ongoing), notes: Hiatal hernia with GERD, Pertinent details: Had LINX surgery; "Prevent covid" (unspecified if ongoing), notes: Prevent covid; "Back pain" (unspecified if ongoing); "Hives", start date: 29Jun2022, stop date: 02Jul2022, notes: Duration of hives: 29Jun2022-02Jul2022; "Headaches" (unspecified if ongoing), notes: Headaches. Concomitant medication(s) included: OXYBUTYNIN oral taken for hypertonic bladder (ongoing); LYRICA oral taken for fibromyalgia (ongoing); CRESTOR oral taken for blood cholesterol increased (ongoing); MVI 118 oral (ongoing); CALCIUM oral taken for osteoporosis (ongoing); TURMERIC + oral taken for arthralgia (ongoing); D3 oral taken for hypovitaminosis; ASA oral taken for cardiac disorder (ongoing); METHENAMINE oral taken for cystitis (ongoing); COENZYME Q10+ oral taken for cardiac disorder (ongoing); B COMPLEX [VITAMIN B COMPLEX] oral taken for confusional state, arthralgia (ongoing); FIBER oral taken for constipation (ongoing); MAGNESIUM oral taken for muscle spasms (ongoing); VERAPAMIL oral taken for stress cardiomyopathy, cardiac disorder (ongoing); SINGULAIR oral taken for asthma (ongoing); BACOFEN oral taken for arthralgia, arthritis, muscle spasms (ongoing); ZERICA oral taken for covid-19 immunisation, start date: 2021; ALBUTEROL HFA taken for asthma (ongoing); FLONASE [FLUTICASONE PROPIONATE]; OXYCODON oral taken for back pain, arthralgia (ongoing); PRILOSEC [OMEPRAZOLE MAGNESIUM] oral taken for gastrooesophageal reflux disease (ongoing); BENADRYL oral taken for hypersensitivity, urticaria; ZYRTEC ALLERGY oral taken for hypersensitivity (ongoing); MELATONIN oral taken for sleep disorder (ongoing); UBRELVY oral taken for migraine, headache. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2022, outcome "unknown" and all described as "COVID-19/Covid-19 test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: I Had numerous other covid tests (nasal) & all other were negative & due to being admitted to Hospital; (Feb2022) Positive.  Clinical course: The patient was sick for 4 days & (Illegible) that when had covid in early Feb2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162b2 to the reported events of vaccination failure and COVID-19 cannot be ruled out given the known suspect product profile and temporal association.