Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Immunisation reaction, Insomnia, Pyrexia, Tremor
Clinical narrative: Exacerbation of asthma/Dyspnoea at rest/ Had shortness of breath/Dyspnoea (difficult/labored breathing)/ Painful respiration; Condition aggravated; Felt like she was shacking in bed/she was shaking; She could not sleep/it kept her awake all night; She got a a little bit of a reaction; Her heart was beating fats; Was really sick; Chest pain; Chest discomfort; Had fever; This spontaneous case was reported by a patient and describes the occurrence of ASTHMA (Exacerbation of asthma/Dyspnoea at rest/ Had shortness of breath/Dyspnoea (difficult/labored breathing)/ Painful respiration) and CONDITION AGGRAVATED (Condition aggravated) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy, Food allergy (and other products,), Environmental allergy, Allergy to molds, Dust allergy, Allergy to animal and Asthma (Patient did not have any asthma anymore because patient protected herself).   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced ASTHMA (Exacerbation of asthma/Dyspnoea at rest/ Had shortness of breath/Dyspnoea (difficult/labored breathing)/ Painful respiration) (seriousness criterion medically significant), CONDITION AGGRAVATED (Condition aggravated) (seriousness criterion medically significant), TREMOR (Felt like she was shacking in bed/she was shaking), INSOMNIA (She could not sleep/it kept her awake all night), IMMUNISATION REACTION (She got a a little bit of a reaction), HEART RATE INCREASED (Her heart was beating fats), ILLNESS (Was really sick), CHEST PAIN (Chest pain), CHEST DISCOMFORT (Chest discomfort) and PYREXIA (Had fever). On 09-Mar-2021, ASTHMA (Exacerbation of asthma/Dyspnoea at rest/ Had shortness of breath/Dyspnoea (difficult/labored breathing)/ Painful respiration), CONDITION AGGRAVATED (Condition aggravated), TREMOR (Felt like she was shacking in bed/she was shaking), INSOMNIA (She could not sleep/it kept her awake all night), IMMUNISATION REACTION (She got a a little bit of a reaction), HEART RATE INCREASED (Her heart was beating fats), ILLNESS (Was really sick), CHEST PAIN (Chest pain), CHEST DISCOMFORT (Chest discomfort) and PYREXIA (Had fever) had resolved.            Patient called because she had to go on a trip in two weeks, and she had to take the first booster and she did not want to. She stated that after the second dose, she had shortness of breath, felt like she was shacking in bed, she could not sleep, it kept her awake all night, she got a little bit of a reaction, she was shaking, her heart was beating fats, had fever, and was really sick, this went on from the 7March2021 to the 9Marhc2021. She had to get the booster and wants to know if she was going to have the same side effects and a very strong aggressive reaction. Patient not ever had COVID positive test or diagnosis. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. AE did not cause patient to seek medical care (office visit, Urgent care, ER, hospitalized). Patient had not experienced a similar event in the past. symptoms improved better after two days. there was no history of Myocarditis/pericarditis. No concomitant medication information was reported. No treatment medication information was reported.  Company comment: This spontaneous case concerns a 54-year-old female patient with relevant medical history of Asthma and Allergy to multiple antigens, who experienced the unexpected serious (medically significant) event of Asthma and Condition aggravated, one day after receiving the 2nd dose of mRNA-1273 vaccine. The outcome was reported as resolved. Details of clinical course, investigation reports and treatment were not provided. Medical history of Asthma and Allergy to multiple antigens remains a confounder. There was no information if the patient had similar events after the 1st dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 54-year-old female patient with relevant medical history of Asthma and Allergy to multiple antigens, who experienced the unexpected serious (medically significant) event of Asthma and Condition aggravated, one day after receiving the 2nd dose of mRNA-1273 vaccine. The outcome was reported as resolved. Details of clinical course, investigation reports and treatment were not provided. Medical history of Asthma and Allergy to multiple antigens remains a confounder. There was no information if the patient had similar events after the 1st dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.