Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: When she came home from hospital, she had another asthma attack and stayed for another week in hospital; Asthma attack due to a reaction to second Covid shot; Diabetic; Poor peripheral circulation; Bruising of leg; Swelling; patient received  first dose on 11-Feb-2021 and second dose on 01-Mar-2021; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Asthma attack due to a reaction to second Covid shot), DIABETES MELLITUS (Diabetic) and ASTHMA (When she came home from hospital, she had another asthma attack and stayed for another week in hospital) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Family history included Polyps (RUN ON MOMS SIDE OF THE FAMILY) since an unknown date. Concurrent medical conditions included Asthma (In Nov 2020, patient diagnosed with Asthma after starting Humira.) since November 2020.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 01-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received  first dose on 11-Feb-2021 and second dose on 01-Mar-2021). In April 2021, the patient experienced ASTHMA (Asthma attack due to a reaction to second Covid shot) (seriousness criterion hospitalization). On an unknown date, the patient experienced DIABETES MELLITUS (Diabetic) (seriousness criterion medically significant), ASTHMA (When she came home from hospital, she had another asthma attack and stayed for another week in hospital) (seriousness criterion hospitalization), POOR PERIPHERAL CIRCULATION (Poor peripheral circulation), CONTUSION (Bruising of leg) and SWELLING (Swelling). The patient was treated with PREDNISONE for Breathing difficult, at an unspecified dose and frequency and INSULIN for Diabetes, at an unspecified dose and frequency. In 2021, ASTHMA (Asthma attack due to a reaction to second Covid shot) was resolving. At the time of the report, DIABETES MELLITUS (Diabetic) and POOR PERIPHERAL CIRCULATION (Poor peripheral circulation) had not resolved and ASTHMA (When she came home from hospital, she had another asthma attack and stayed for another week in hospital), CONTUSION (Bruising of leg), SWELLING (Swelling) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received  first dose on 11-Feb-2021 and second dose on 01-Mar-2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 01-Dec-2020, patient had 3rd Covid test with unknown results.  The reporter's causality for the events of asthma attack, pneumonia and diabetic with Humira was no reasonable possibility and bruised leg on outside and poor circulation , sting and painful, swelling went down and asthma issue or asthma was acting up or asthma flare was not provided.  This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in  Company comment: This is a spontaneous case reported by a consumer. A 74-year-old female patient, with concurrent medical conditions of asthma and rheumatoid arthritis, completed a two-dose primary series of mRNA-1273 vaccine with an interval of 18 days between doses and experienced serious event of asthma attack after second dose. Exact onset date of the event was not provided; hence, latency cannot be assessed. Se was hospitalized for two weeks, treatment included prednisone and not specified breathing treatment. It was also reported that she took insulin for diabetes, but it is unknown if this was a pre-existing medical condition. When she came home from hospital, she had another asthma attack and stayed for another week in hospital. She required three liters of oxygen 24/7. On an unknown day, patient was treated with antibiotics due to bruised leg and poor circulation. Patient stated that she experienced asthma attacks and pneumonia after first COVID shot but no more information regarding this events was provided. It is unknown if patient was exposed to asthma attack triggers such as tobacco smoke, pollen, mold and stress. Regarding Adalimumab, which was reported as co-suspect drug, it could be a contributory factor for asthma and pneumonia. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-625120 (Patient Link).; Sender's Comments: This is a spontaneous case reported by a consumer. A 74-year-old female patient, with relevant concurrent conditions of asthma and rheumatoid arthritis, completed a two-dose primary series of mRNA-1273 vaccine with an interval of 18 days between doses and experienced serious event of asthma attack after second dose. Exact onset date of the event was not provided; hence, latency cannot be assessed. Se was hospitalized for two weeks, treatment included prednisone and not specified breathing treatment. It was also reported that she took insulin for diabetes, but it is unknown if this was a pre-existing medical condition. When she came home from hospital, she had another asthma attack and stayed for another week in hospital. She required three liters of oxygen 24/7. On an unknown day, patient was treated with antibiotics due to bruised leg and poor circulation. Patient stated that she experienced asthma attacks and pneumonia after first COVID shot but no more information regarding this events was provided. It is unknown if patient was exposed to asthma attack triggers such as tobacco smoke, pollen, mold and stress. Regarding Adalimumab, which was reported as co-suspect drug, it could be a contributory factor for asthma and pneumonia. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.