Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Oxygen saturation, Respiratory rate, SARS-CoV-2 test, Weight
Clinical narrative: Interchange of vaccine products; Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 72-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Dec2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 06May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23Jan2021 as dose 1, single (Batch/Lot number: unknown), on 20Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 08Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Nonrheumatic aortic valve insufficiency" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "Essential Hypertension" (unspecified if ongoing); "Dysmetabolic syndrom X" (unspecified if ongoing); "Multinodular goiter" (unspecified if ongoing); "Vitamin D deficiency" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Acquired Hypothyroidism" (unspecified if ongoing); "Vertigo Benign positional" (unspecified if ongoing); "Sensorineural hearing loss" (unspecified if ongoing), notes: Sensorineural hearing loss, bilateral; "Subjective tinnitus of both ears" (unspecified if ongoing); "Acute recurrent maxillary sinusitis" (unspecified if ongoing); "Diverticulosis" (unspecified if ongoing); "Esophagitis reflux" (unspecified if ongoing); "Hiatal Hernia" (unspecified if ongoing); "Laryngopharyngeal reflux" (unspecified if ongoing); "GI bleed" (unspecified if ongoing); "Schatzki's ring" (unspecified if ongoing); "Gastroesophageal reflux disease without esophagitis" (unspecified if ongoing); "Constipation" (unspecified if ongoing); "Postmenopausal atrophic vaginitis" (unspecified if ongoing); "Asymptomatic Postmenopausal status" (unspecified if ongoing); "Acute cystitis without hematuria" (unspecified if ongoing), notes: Acute cystitis without hematuria; "UTI" (unspecified if ongoing); "Lipoma" (unspecified if ongoing); "Iron deficiency anemia" (unspecified if ongoing), notes: Iron deficiency anemia due to chronic blood loss; "MGUS" (unspecified if ongoing); "West nile virus" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Osteopenia" (unspecified if ongoing); "Knee pain" (unspecified if ongoing); "Neck pain" (unspecified if ongoing); "Costochondritis" (unspecified if ongoing); "Psoriatic arthritis" (unspecified if ongoing); "Pain, Joint, Knee, right" (unspecified if ongoing); "Pain in right foot" (unspecified if ongoing); "Localized primary osteoarthritis" (unspecified if ongoing); "Carpometacarpal (CMC) joint of left wrist" (unspecified if ongoing), notes: Carpometacarpal (CMC) joint of left wrist; "Psoriatic arthropathy" (unspecified if ongoing); "Osteoarthritis of knee" (unspecified if ongoing); "Migraine headache" (unspecified if ongoing); "Polyneuropathy" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "Shortness of breath" (unspecified if ongoing); "Psoriasis" (unspecified if ongoing); "Tinea unguium" (unspecified if ongoing); "Ingrowing nail" (unspecified if ongoing); "Erythema nodosum" (unspecified if ongoing); "Blood transfusion", start date: Nov2018 (unspecified if ongoing); "Chest pain", start date: 30Apr2012 (unspecified if ongoing); "Acute upper respiratory infection", start date: 31May2009, stop date: 31Dec2010; "Anxiety with depression" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Benign paroxymal positional vertigo" (unspecified if ongoing); "Complication of anesthesia" (unspecified if ongoing); "Duodenal ulcer" (unspecified if ongoing); "Enlarged aorta" (unspecified if ongoing); "Esophageal Stricture" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Hypertension" (unspecified if ongoing), notes: Hypertension off medication since Weight loss; "Weight loss" (unspecified if ongoing), notes: Hypertension off medication since Weight loss; "Leaky heart valve aortic valve" (unspecified if ongoing); "Lower back pain" (unspecified if ongoing); "Motion sickness" (unspecified if ongoing); "nontoxic uninodular goiter" (unspecified if ongoing); "Osteopenia" (unspecified if ongoing); "PONV" (unspecified if ongoing); "Upper gastrointestinal endoscopy", start date: 17Mar2021 (unspecified if ongoing), notes: bottom of the esophagus showed GERD. Stomach and small bowel biopsies showed mild inflammation likely secondary to acid; "Colonoscopy", start date: 28Dec2018 (unspecified if ongoing); "Breast reduction surgery" (not ongoing); "esophagogastroduodenoscopy", start date: 2000 (unspecified if ongoing); "Hysterectomy" (not ongoing), notes: tah with bso before pt had complete Hysterectomy due to fibroids and AUB; "Unspecified vitamin D deficiency" (unspecified if ongoing); "Smoking Status Never" (unspecified if ongoing); "Anemia", start date: 14Nov2018 (unspecified if ongoing). The patient's family history included: "Diabetes" (unspecified if ongoing), notes: Father (De Diabetes Coronary artery disease , Hypertension , Cancer; "coronary artery disease" (unspecified if ongoing); "Thyroid disease had thyroid surgery" (unspecified if ongoing), notes: Mother (D Thyroid disease had thyroid surgery; "Colorectal Cancer" (unspecified if ongoing), notes: Brother Colorectal Cancer; "Kidney cancer" (unspecified if ongoing), notes: Brother Kidney cancer; "bleeding problem" (unspecified if ongoing); "Clotting disorder" (unspecified if ongoing); "Cancer" (unspecified if ongoing), notes: Father (De Diabetes Coronary artery disease , Hypertension , Cancer; "Hypertension" (unspecified if ongoing), notes: Father (De Diabetes Coronary artery disease , Hypertension , Cancer. The patient's concomitant medications were not reported. Past drug history included: Biaxin, reaction(s): "Itching"; Biaxin, reaction(s): "Drug allergy"; Ceftin, reaction(s): "Rash"; Ceftin, reaction(s): "Drug allergy"; Levaquin, reaction(s): "Drug allergy"; Vioxx, reaction(s): "Drug allergy". Vaccination history included: influenza virus vaccine, administration date: 15Oct2015, for influenza immunization; influenza virus vaccine, administration date: 13Oct2016, for influenza immunization; influenza virus vaccine, administration date: 14Oct2014, for influenza immunization; influenza virus vaccine, administration date: 01Nov2012, for influenza immunization; influenza virus vaccine, administration date: 26Sep2019, for influenza immunization; influenza virus vaccine, administration date: 08Oct2018, for influenza immunization; influenza virus vaccine, administration date: 15Sep2017, for influenza immunization; influenza virus vaccine, administration date: 20Sep2022, for influenza immunization; influenza virus vaccine, administration date: 29Sep2021, for influenza immunization; influenza virus vaccine, administration date: 16Sep2020, for influenza immunization; pneumococcal conjugate pcv 13, administration date: 17Feb2016, for Immunization; pneumococcal polysaccharide, administration date: 07Dec2017, for Immunization; pneumococcal polysaccharide, administration date: 29Nov2006, for Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown"; DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Blood calcium: (14Mar2023) Unknown Results; Body height: (16Feb2023) 1.575 m; (19Feb2023) 1.575 m; Body mass index: (01Jan2023) 24.07; (16Feb2023) 24.14; (19Feb2023) 23.78; Body surface area: (16Feb2023) 1.62 sq meteres; (19Feb2023) 1.61 sq meteres; Body temperature: (01Jan2023) 97.8 Fahrenheit; (16Feb2023) 98.9 Fahrenheit; (19Feb2023) 97.9 Fahrenheit; Endoscopy: (15Nov2018) Negative; (03Mar2020) Unknown Results; (17Mar2021) Upper gastrointestinal endoscopy bottom of the eso, notes: Upper gastrointestinal endoscopy bottom of the esophagus showed GERD; Full blood count: (14Mar2023) Unknown Results; Heart rate: (01Jan2023) 69; (16Feb2023) 69; (19Feb2023) 69; Oxygen saturation: (01Jan2023) RA; (19Feb2023) RA; Oxygen saturation: (01Jan2023) 96 %; (16Feb2023) 96 %; (19Feb2023) 94 %; Respiratory rate: (01Jan2023) 16; (16Feb2023) 16; (19Feb2023) 16; SARS-CoV-2 test: (unspecified date) Positive, notes: Reason for use: Covid+ve; Weight: (01Jan2023) 59.7 kg; (16Feb2023) 59.9 kg; (19Feb2023) 59 kg; X-ray: (13Mar2023) Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Took paxlovid 2 tablets for positive COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events interchange of vaccine products, Covid-19, and drug ineffective are related to BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5) cannot be excluded. This case will be reassessed should additional information become available.,Linked Report(s) : US-PFIZER INC-202300059050 same patient, different drug, different events.;