Sex: F
Vaccine: COVID19, COVID19
Symptoms: Audiogram, Diarrhoea, Nausea, Tinnitus, Vomiting
Clinical narrative: tinnitus; ear infection; This is a spontaneous report received from a Nurse from medical information team.  A 71-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "visually impaired" (unspecified if ongoing); "Diabetes Mellitus type II", start date: 1995 (unspecified if ongoing); "hypertension" (unspecified if ongoing); "DJD", start date: 1996 (unspecified if ongoing); "macular degeneration", start date: 2007 (unspecified if ongoing); "Tubolovillous adenoma polyp of colon", start date: 2010 (unspecified if ongoing); "asthma", start date: 05Mar2019 (unspecified if ongoing); "low back pain", start date: 08Apr2020 (ongoing); "deviated septum", start date: Jan2011 (unspecified if ongoing); "carpal tunnel syndrome" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "complication of anesthesia" (unspecified if ongoing); "OSA", start date: 1995 (unspecified if ongoing); "pure hypercholesterolemia" (unspecified if ongoing); "CKD stage 4", start date: 23Mar2017 (unspecified if ongoing); "hepatitis", start date: 1980 (unspecified if ongoing); "morbid obesity", start date: 03Mar2018 (ongoing); "cataract sugery", start date: 14Mar2017 (not ongoing); "gout", start date: 2016 (unspecified if ongoing); "tonsillectomy and adenoidectomy" (not ongoing); "carpal tunnel release", start date: 1988 (not ongoing); "lipoma resection" (not ongoing), notes: 1990s; "appendectomy", start date: 1959 (not ongoing); "ventral hernia repair", start date: 1981 (not ongoing); "cesarean" (not ongoing); "repair of knee joint", start date: 1980 (not ongoing), notes: 1980 and 2003; "interphalangeal joint replacement", start date: 2004 (not ongoing); "dialtion and curettge", start date: 1994 (not ongoing); "colonoscopy", start date: 06Feb2010 (unspecified if ongoing), notes: flexible, w/ removal of tumor(s), polyp(s) or other lesion(s); "rotator cuff repair", start date: 2003 (not ongoing), notes: 2003 and 2005; "cyst removal", start date: 16Feb2012 (not ongoing); "Destruc, ciliary body, cryotherapy", start date: 13Dec2012 (not ongoing); "former smoker", stop date: 08Jan2015, notes: 1 pack per day for 40 years; "injection", start date: 16Jan2014 (not ongoing), notes: PB injection, anesthetic/steroid, paravertebral Facet joint/nerve, lumbar/sacral; "shoulder replacement", start date: 26Feb2015 (not ongoing); "knee replacement", start date: 20Mar2017 (not ongoing); "cataract removal", start date: 05Feb2017 (not ongoing); "revision total knee arthroplasty", start date: 12Jun2018 (not ongoing); "orthopedic surgery", start date: 03May2022 (not ongoing); "knee replacement", start date: 14Mar2023 (not ongoing); "eye surgery", start date: 2017 (not ongoing), notes: 2017 and 2018; "joint replacement", start date: 26Jan2015 (not ongoing); "spine surgery", start date: 02Mar2020 (not ongoing), notes: Spinal fusion L3-L5; "tubal ligation", start date: 1980 (not ongoing); "nocturnal hypoxia", start date: 07Jun2017 (ongoing); "tobacco abuse", start date: 07Jun2017 (ongoing); "secondary hyperparathyroidism", start date: 02Jun2020 (ongoing); "nuts allergy", start date: 22Jul2013 (unspecified if ongoing), notes: respiratory distress; "wine spirit allergy", start date: 22Jul2013 (unspecified if ongoing); "black pepper allergy", start date: 22Jul2013 (unspecified if ongoing), notes: diarrhea; "Pepper allergy", start date: 06Oct2016 (unspecified if ongoing), notes: respiratory distress; "grape allergy", start date: 06Oct2016 (unspecified if ongoing), notes: respiratory distress; "cataract removal", start date: 02May2017 (not ongoing), notes: OD; "joint replacement", start date: 18Jun2017 (not ongoing); "joint replacement", start date: 12Jun2018 (not ongoing); "nerve block to left knee", start date: 09Jan2018 (not ongoing); "left knee neuroma removal", start date: 04Aug2017 (not ongoing); "macular subretinal hemorrhage for left eye", start date: 15Mar2018 (unspecified if ongoing); "Pain" (unspecified if ongoing); "wheezing" (unspecified if ongoing); "shortness of breath" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "constipation" (unspecified if ongoing); "Insomnia" (ongoing). The patient's concomitant medications were not reported. Past drug history included: Midazolam, start date: 17Feb2011, reaction(s): "drug allergy"; Pentazocine lactate, start date: 23Sep2011, reaction(s): "tongue swelling"; Propantheline, start date: 15Feb2012, reaction(s): "respiratory distress"; Hydrocodone-acetaminophen, start date: 02Apr2012, reaction(s): "mental status changes"; Hydrocodone-acetaminophen, start date: 02Apr2012, reaction(s): "dizziness"; Neomycin-bacit-polymyx-pramoxine, start date: 28Sep2012, reaction(s): "urticaria"; Neomycin-bacit-polymyx-pramoxine, start date: 28Sep2012, reaction(s): "rash"; Nitroglycerin, start date: 22Jul2013, reaction(s): "dizziness"; Morphine, start date: 22Jul2013, reaction(s): "narcotic intolerance". Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 30Jan2021, when the patient was 67-year-old, for COVID-19 immunization; hep b vaccine (DOSE NUMBER UNKNOWN, SINGLE), administration date: 20May2010, when the patient was 57-year-old, for Hepatitis immunization; hep b vaccine (DOSE NUMBER UNKNOWN, SINGLE), administration date: 14Dec2009, when the patient was 56-year-old, for Hepatitis immunization; hep b vaccine (DOSE NUMBER UNKNOWN, SINGLE), administration date: 13Nov2009, when the patient was 56-year-old, for Hepatitis immunization; influenza (flu) vaccine (DOSE NUMBER UNKNOWN, SINGLE), administration date: 23Sep2019, when the patient was 66-year-old, for influenza immunization; influenza (flu) vaccine (DOSE NUMBER UNKNOWN, SINGLE), administration date: 09Feb2017, when the patient was 63-year-old, for influenza immunization; influenza (flu) vaccine (DOSE NUMBER UNKNOWN, SINGLE), administration date: 11Jan2016, when the patient was 62-year-old, for influenza immunization; influenza (flu) vaccine (DOSE NUMBER UNKNOWN, SINGLE), administration date: 30Aug2016, when the patient was 63-year-old, for influenza immunization; influenza (flu) vaccine (DOSE NUMBER UNKNOWN, SINGLE), administration date: 14Sep2015, when the patient was 62-year-old, for influenza immunization; influenza (flu) vaccine (DOSE NUMBER UNKNOWN, SINGLE), administration date: 13Sep2015, when the patient was 62-year-old, for influenza immunization; influenza (flu) vaccine (DOSE NUMBER UNKNOWN, SINGLE), administration date: 17Oct2014, when the patient was 61-year-old, for influenza immunization; influenza (flu) vaccine (DOSE NUMBER UNKNOWN, SINGLE), administration date: 18Oct2013, when the patient was 60-year-old, for influenza immunization; influenza (flu) vaccine (DOSE NUMBER UNKNOWN, SINGLE), administration date: 28Sep2012, when the patient was 59-year-old, for influenza immunization; influenza (flu) vaccine (DOSE NUMBER UNKNOWN, SINGLE), administration date: 17Nov2011, when the patient was 58-year-old, for influenza immunization; influenza (flu) vaccine (DOSE NUMBER UNKNOWN, SINGLE), administration date: 10Jan2010, when the patient was 56-year-old, for influenza immunization; influenza (flu) vaccine (DOSE NUMBER UNKNOWN, SINGLE), administration date: 12Oct2023, when the patient was 70-year-old, for influenza immunization; influenza (flu) vaccine (quadrivalent) (DOSE NUMBER UNKNOWN, SINGLE), administration date: 01Oct2020, when the patient was 67-year-old, for influenza immunization; influenza (flu) vaccine (quadrivalent) (DOSE NUMBER UNKNOWN, SINGLE), administration date: 10Oct2018, when the patient was 65-year-old, for influenza immunization; influenza (flu) vaccine (high dose) (DOSE NUMBER UNKNOWN, SINGLE), administration date: 29Sep2019, when the patient was 66-year-old, for influenza immunization; influenza (flu) vaccine (high dose) (DOSE NUMBER UNKNOWN, SINGLE), administration date: 09Oct2018, when the patient was 65-year-old, for influenza immunization; influenza (flu) vaccine (monovalent) (DOSE NUMBER UNKNOWN, SINGLE), administration date: 13Nov2009, when the patient was 56-year-old, for influenza immunization; influenza (flu) vaccine (quadrivalent) (DOSE NUMBER UNKNOWN, SINGLE), administration date: 10Jan2020, when the patient was 66-year-old, for influenza immunization; influenza injectable quadrivalent, preserv free (DOSE NUMBER UNKNOWN, SINGLE), administration date: 09Jan2017, when the patient was 63-year-old, for influenza immunization; influenza injectable quadrivalent, preserv free (DOSE NUMBER UNKNOWN, SINGLE), administration date: 29Aug2016, when the patient was 63-year-old, for influenza immunization; influenza injectable quadrivalent, preserv free (DOSE NUMBER UNKNOWN, SINGLE), administration date: 29Sep2012, when the patient was 59-year-old, for influenza immunization; influenza injectable quadrivalent, preserv free (DOSE NUMBER UNKNOWN, SINGLE), administration date: 17Nov2011, when the patient was 58-year-old, for influenza immunization; pneumococcal vaccine (DOSE NUMBER UNKNOWN, SINGLE), administration date: 06Jan2018, when the patient was 64-year-old, for immunization; pneumococcal vaccine (pollyvalent) (DOSE NUMBER UNKNOWN, SINGLE), administration date: 06Apr2019, when the patient was 66-year-old, for immunization; tdap vaccine (DOSE NUMBER UNKNOWN, SINGLE), administration date: 10Sep2019, when the patient was 66-year-old, for immunization; tdap vaccine (DOSE NUMBER UNKNOWN, SINGLE), administration date: 09Nov2009, when the patient was 66-year-old, for immunization; BNT162b2 (at time 14:30, Route of Administration Intramuscular, Dose 2, Single), administration date: 20Feb2021, when the patient was 67-year-old, for COVID-19 immunization, reaction(s): "peroneal neuropathy", "right hip hematoma", "bilateral tinnitus/hissing tinnitus", "Triglyceride increased", "HDL low", "Hemoglobin A1C increased", "Potassium high", "BUN increased", "Creatinine increased", "Glucose high", "Albumin low", "Anxiety", "Balance disorder", "Head spinning", "Arthralgia", "Walking difficulty", "Fatigue", "Blurred vision", "Double vision", "Memory loss", "Eye disorder", "fever", "chills", "hearing difficulties", "Nausea", "vomiting", "Otalgia", "underlying insomnia". The following information was reported: TINNITUS (non-serious), outcome "unknown"; EAR INFECTION (non-serious), outcome "unknown". The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.