Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Chest X-ray, Cough, Immunodeficiency, Insomnia
Clinical narrative: they had an asthma attach or exacerbation/Pfizer BioNTech Bivalent COVID-19 Vaccine: asthma exacerbation/so her asthma exacerbation began a few days prior to caller's dad; She was coughing when laying down and couldn't sleep; She was coughing when laying down and couldn't sleep; she had more severe persistent cough and wheeze; immunocompromised; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group, Program ID: (159558).  A 78-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Nov2022 as dose 4 (booster), single (Lot number: GK0924) at the age of 77 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: Apr2021 (unspecified if ongoing), notes: she was hospitalized in Apr2021 for COVID, was not in ICU just in general unit. Concomitant medication(s) included: FENOFIBRATE (ongoing); ATORVASTATIN (ongoing). Vaccination history included: covishield (Dose 1, Single, CoviShield COVID vaccine: COVID), administration date: 19Mar2021, when the patient was 76-year-old, for COVID-19 immunisation, reaction(s): "COVID"; covishield (Dose 2, Single, CoviShield COVID vaccine: COVID), administration date: 17Aug2021, when the patient was 76-year-old, for COVID-19 immunisation, reaction(s): "COVID"; covishield (Dose 3, Single, CoviShield COVID vaccine: COVID), administration date: 18May2022, when the patient was 77-year-old, for COVID-19 immunisation, reaction(s): "COVID". The following information was reported: COUGH (non-serious), INSOMNIA (non-serious) all with onset 2022, outcome "unknown" and all described as "She was coughing when laying down and couldn't sleep"; IMMUNODEFICIENCY (medically significant) with onset 2022, outcome "unknown", described as "immunocompromised"; WHEEZING (non-serious) with onset 2022, outcome "unknown", described as "she had more severe persistent cough and wheeze"; ASTHMA (non-serious) with onset Nov2022, outcome "unknown", described as "they had an asthma attach or exacerbation/Pfizer BioNTech Bivalent COVID-19 Vaccine: asthma exacerbation/so her asthma exacerbation began a few days prior to caller's dad". The events "immunocompromised", "they had an asthma attach or exacerbation/pfizer biontech bivalent covid-19 vaccine: asthma exacerbation/so her asthma exacerbation began a few days prior to caller's dad", "she was coughing when laying down and couldn't sleep" and "she had more severe persistent cough and wheeze" required physician office visit. The patient underwent the following laboratory tests and procedures: Chest X-ray: (2022) lungs were clear, notes: for pneumonia; Viral test: (2022) did not have flu. Therapeutic measures were taken as a result of asthma included 10 days of Prednisone and some other medications.  Additional information: Case is serious as per reporter. Vaccine was administered in left shoulder in upper deltoid because she was right-handed. Reporter stated after the bivalent dose parents who are 80 and 78 years of age had asthma exacerbation or attacks about two weeks after the dose and took Prednisone for 10 days. Reporter confirmed details and stated the doctor also prescribes a few more medications along with the Prednisone. Reporter dose not know if vaccine was causing the asthma exacerbation. It was odd for them to both have it at the same time, so caller took both parents to the (withheld) Urgent Care. Patients asthma exacerbation began a few days prior to caller's dad and mom was more severe. It started probably 3-4 days after the Pfizer BioNTech Bivalent COVID-19 Vaccine. Patient was having coughing when laying down and couldn't sleep. They did a flu swab, and she did not have flu. There was no prior vaccinations (within 4 weeks). There was no family Medical History Relevant to Adverse Event. doctor told reporter to watch patient carefully because she had more severe persistent cough and wheeze. Reporter was seeking information on if the bivalent vaccine has been approved for a second dose or are they up to dose if they have only had 1 bivalent dose no matter how long ago. Asked if there was data on a second dose being given in immunocompromised patient. The report was not related to a study or programme.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300003744 Same reporter/vaccine/event, different patient;