Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Investigation, Sleep disorder, Weight
Clinical narrative: Dose 1=Dose 2=Dose 3=CoviShield and Dose 4=Pfizer; immunocompromised; coughing; couldn't sleep; they had an asthma attach or exacerbation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  An 80-year-old male 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 80 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "scarring in lungs" (unspecified if ongoing); "Asthma" (unspecified if ongoing), notes: He had already had asthma trouble as he was growing up, but never had attacks that; "Sulfonamide allergy" (unspecified if ongoing), notes: Caller's dad is allergic to sulfa drugs; "fibrosis" (unspecified if ongoing), notes: Caller thinks it was fibrosis, some evidence of fibrosis; "COVID", start date: Apr2021 (unspecified if ongoing), notes: was in ICU for Covid for 3 weeks in Apr2021 after having Covid Vaccine manufactured by CoviShield.; "hospitalization", start date: Apr2021 (unspecified if ongoing); "diabetes", start date: Apr2021 (ongoing). Concomitant medication(s) included: METFORMIN taken for diabetes mellitus, start date: Apr2021 (ongoing); FENOFIBRATE, start date: Apr2021 (ongoing); ATORVASTATIN (ongoing); LEVODOPA CARBIDOPA taken for tremor (ongoing). Past drug history included: Insulin, notes: Prior to hospitalization, he was not a diabetic. He was on insulin. Vaccination history included: covishield (First dose given on 19Mar2021), administration date: 19Mar2021, when the patient was 78-year-old, for COVID-19 immunization, reaction(s): "COVID"; covishield (second dose given on 15Sep2021), administration date: 15Sep2021, when the patient was 79-year-old, for COVID-19 immunization; covishield (third dose given on 17Jun2022), administration date: 17Jun2022, when the patient was 79-year-old, for COVID-19 immunization. The following information was reported: ASTHMA (medically significant) with onset Nov2022, outcome "unknown", described as "they had an asthma attach or exacerbation"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose 1=Dose 2=Dose 3=CoviShield and Dose 4=Pfizer"; IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "immunocompromised"; COUGH (non-serious), outcome "unknown", described as "coughing"; SLEEP DISORDER (non-serious), outcome "unknown", described as "couldn't sleep". The patient underwent the following laboratory tests and procedures: Chest X-ray: Unknown results; Influenza virus test: Unknown results, notes: Did a flu swab and he did not have flu at that time; examined ears and throat and listened to his lungs: Unknown results; Thrombocytopenia: n/a, notes: Thrombocytopenia: n/a; Weight: 53 or 54 kilograms, notes: 53 or 54 kilograms. Therapeutic measures were taken as a result of asthma.  Clinical information: Caller 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? Is there data on a second dose being given in immunocompromised patients?. Caller is reporting after the bivalent dose their 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 provided by transfer agent and states the doctor also prescribes a few more medications along with the Prednisone. Reporter did not  know if the vaccine was causing the asthma exacerbation. This report is for the 80 year old, which is caller's dad. Asthma Exacerbation started a week after he received the Pfizer vaccine. It gradually got worse. He tried a few things. A week after the exacerbation started, he went to the doctor. Treatment: was given Prednisone and a few more medications. was in ICU for Covid for 3 weeks in Apr2021. Was started on Metformin while there. He was given so much steroids while in the hospital. Prior to hospitalization, he was not a diabetic. He was on insulin, but now just on Metformin. had scaring in lungs after Covid. He had already had asthma trouble as he was growing up, but never had attacks that caller remembers in his life. Scarring in his lungs was post Covid, but caller doesn't remember the medical terms. Reporter thaught it was fibrosis, some evidence of fibrosis. The doctor didn't do blood work. The doctor did a chest X-ray and examination. The doctor examined ears and throat and listened to his lungs. no doctor called for follow up and said if no marked improvement in 3-4 days for caller's dad to go to ER due to his age and the timing. His dad did not have to go to ER. At the same time this occurred there was a flu thing going on and RSV thing. His dad didn't have that, but it was going around at the time. Did a flu swab and he did not have flu at that time. Physician Office: went to clinic. Caller is curious if flare up of asthma has been reported before. His mom never had asthma prior to having Covid or after. Caller initially asked about his parents getting one more shot because caller was worried about about them having Prednisone for 10 days and now being immunocompromised.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300003907 Same reporter/vaccine/event, different patient;