Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Product use issue, Productive cough, Sinusitis
Clinical narrative: Worsened productive cough; sinus infection; experienced continued/worsened symptoms; Product use for unapproved combination; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 70-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 70 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA), on 04Oct2022 as single, vaccine: high-dose influenza, no. of previous doses: yearly (Lot number: UT7714CA) intramuscular, in left deltoid for immunisation. The patient's relevant medical history included: "Chronic Urticaria" (ongoing); "Chronic Osteoporosis" (ongoing); "Chronic Pre-diabetes" (ongoing); "Chronic Dyslipidemia" (ongoing); "Is the patient a smoker? No" (unspecified if ongoing), notes: Unknown if Former smoker; "Chronic rhinitis" (unspecified if ongoing); "Sinus infection prior to infection" (ongoing), notes: Diagnosed with sinus infection prior to infection. Concomitant medication(s) included: ALENDRONATE SODIUM oral taken for osteoporosis, start date: 01Dec2021 (ongoing); SPIRONOLACTONE oral (ongoing); CALCIUM oral taken for mineral supplementation (ongoing); VITAMIN D [COLECALCIFEROL] oral taken for vitamin supplementation (ongoing); FLONASE [FLUTICASONE PROPIONATE] nasal taken for supplementation therapy (ongoing). Vaccination history included: BNT162b2 (Dose 1, Single, Site of injection: Left arm, Route: IM (Intramuscular), COVID-19 Vaccine Name: Pfizer 12 plus Primary, Batch/Lot number: EN5318, Given by Pharmacy/State response), administration date: 05Feb2021, when the patient was 68-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Single, Site of injection: Left arm, Route: IM (Intramuscular) , COVID-19 Vaccine Name: Pfizer 12 plus Primary, Batch/Lot number: EL9266, Given by state response site), administration date: 26Feb2021, when the patient was 68-year-old, for COVID-19 immunization; BNT162b2 (Dose 3 (booster), single, Site of injection: Left arm, Route: IM (Intramuscular) , COVID-19 Vaccine Name: Pfizer 12 plus Primary, Batch/Lot number: FE3592, Given by Pharmacy), administration date: 15Oct2021, when the patient was 69-year-old, for COVID-19 immunization; BNT162b2 (Dose 4 (booster), single, Site of injection: Left arm (upper), Route: IM (Intramuscular) , COVID-19 Vaccine Name: Pfizer 12plus Primary, Batch/Lot number: FJ4991, Given by Pharmacy), administration date: 18May2022, when the patient was 69-year-old, for COVID-19 immunization; shingrix (Vaccine Name: Shingrix, Manufacturer: GSK, Batch/Lot#: 93FR9, Route: IM (Intramuscular), Anatomical Site of Infection: Left Deltoid, No. of Previous Doses: , 1. Shingrix, 2. Zostervax, Date: 04Jan2021), administration date: 04Jan2021, when the patient was 68-year-old, for Immunization; Zostervax (No. of Previous Doses: , 1. Shingrix, 2. Zostervax (two prior Zostervax given), Patient age: 68, 69, 70 Years), for Immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 04Oct2022, outcome "unknown", described as "Product use for unapproved combination"; CONDITION AGGRAVATED (non-serious) with onset 28Feb2023, outcome "unknown", described as "experienced continued/worsened symptoms"; SINUSITIS (non-serious) with onset 28Feb2023, outcome "unknown", described as "sinus infection"; PRODUCTIVE COUGH (non-serious), outcome "unknown", described as "Worsened productive cough". Therapeutic measures were taken as a result of sinusitis, condition aggravated.  Additional information: Diagnosed with sinus infection prior to infection. Experienced continued/worsened symptoms. Date of sinus infection reported to be 28Feb2023. The patient was given Amoxicillin for Sinus Infection via oral route from 28Feb2023 to 10Mar2023. The information on any new or worsened symptoms/signs during the COVID-19 illness experienced (including date of onset/ worsening) included other: congestion, fatigue, aches, malaise, nasal, nasal/sinus drainage (worsening symptoms on top of sinus infection). Worsened productive cough; initially started with sinus infection. Patient was not evaluated within office presumptive 'no' for unknown.