Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Blood pressure measurement, Chest pain, Condition aggravated, Electrocardiogram
Clinical narrative: High Blood Pressure 171/110 mmHg after half dose booster; Asthma symptoms got worst,Asthma flare up got worst after half dose booster; Heart rate increased, rapid heart rate 118 BPH after half dose booster; Chest Pain after half dose booster; Asthma symptoms got worst/Asthma flare up got worst after half dose booster; This spontaneous case was reported by a nurse and describes the occurrence of HYPERTENSION (High Blood Pressure 171/110 mmHg after half dose booster) and ASTHMA (Asthma symptoms got worst,Asthma flare up got worst after half dose booster) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer (last Medication cancer treatment was on FEB2021 (Letrozole)), Sinus infection (had a sinus infection, but no COVID) in 2021 and Mastectomy (Mastectomy and Breast Cancer medications in 2015). Concurrent medical conditions included Asthma. Concomitant products included LETROZOLE for Breast cancer.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2022, the patient experienced HYPERTENSION (High Blood Pressure 171/110 mmHg after half dose booster) (seriousness criterion medically significant), ASTHMA (Asthma symptoms got worst,Asthma flare up got worst after half dose booster) (seriousness criterion medically significant), TACHYCARDIA (Heart rate increased, rapid heart rate 118 BPH after half dose booster), CHEST PAIN (Chest Pain after half dose booster) and CONDITION AGGRAVATED (Asthma symptoms got worst/Asthma flare up got worst after half dose booster). The patient was treated with AMLODIPINE for Hypertension, at a dose of Unknown; LEVALBUTEROL HCL for Asthma, at a dose of Unknown and FLUTICASONE PROPIONATE (FLOVENT) for Asthma, at a dose of Unknown. At the time of the report, HYPERTENSION (High Blood Pressure 171/110 mmHg after half dose booster), ASTHMA (Asthma symptoms got worst,Asthma flare up got worst after half dose booster), TACHYCARDIA (Heart rate increased, rapid heart rate 118 BPH after half dose booster) and CHEST PAIN (Chest Pain after half dose booster) had not resolved and CONDITION AGGRAVATED (Asthma symptoms got worst/Asthma flare up got worst after half dose booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2022, Blood pressure measurement: 171/110 mmhg (High) 171/110 mmHg. On 08-Feb-2022, Heart rate: 118bpm (High) rapid heart rate 118BPM. On 09-Feb-2022, Electrocardiogram: normal (normal) EKG was normal at the ER and at the cardiologist office.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient visited the Emergency room and after a while, the blood pressure came down without using any medicine. Two hours after leaving the ER, all symptoms came back. The next day, she walked into doctor's office and the doctor started her on Amlodipine.  Patient had never had a positive COVID test. She states, to the best of her knowledge, she never had COVID disease, and she states that she had a diagnosis of Asthma prior to vaccination, but it never flared up unless if she had the flu. She never used a maintenance inhaler to manage Asthma.  She states that she does not have Pericarditis and Myocarditis.  The Asthma doctor started her on Levalbuterol Inhaler, and Flovent Inhaler. The cardiologist gave her a portable cardio monitor and she had a cat scan of the heart scheduled for APR-2022.  Patient was asking that has anyone else reported worsening of asthma symptoms after 2nd booster dose.  Company Comment : This is a spontaneous case concerning a 68-year-old female patient with relevant medical history of Asthma and Breast Cancer with Chemotherapy, who experienced the unexpected serious event of Hypertension and Asthma. The events were medically significant and occurred the same day after receiving the fourth booster dose of mRNA-1273 Vaccine. As reported, the patient has worsening symptoms of asthma, high blood pressure, chest pain, and tachycardia. She visited the emergency room where ECG was normal and symptoms resolved without treatment, however the symptoms came back two hours after her emergency room visit. She had a consultation at a doctor's clinic where she was given Amlodipine as treatment for hypertension. Her asthma doctor prescribed Levalbuterol and Flovent Inhaler asthma. It was reported that the outcome of the events has not resolved. The medical history of remains a confounder Asthma. A fourth dose of the mRNA-1273 was given to this patient considering her Immunocompromised state with Breast Cancer with Chemotherapy. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 68-year-old female patient with relevant medical history of Asthma and Breast Cancer with Chemotherapy, who experienced the unexpected serious event of Hypertension and Asthma. The events were medically significant and occurred the same day after receiving the fourth booster dose of mRNA-1273 Vaccine. As reported, the patient has worsening symptoms of asthma, high blood pressure, chest pain, and tachycardia. She visited the emergency room where ECG was normal and symptoms resolved without treatment, however the symptoms came back two hours after her emergency room visit. She had a consultation at a doctor's clinic where she was given Amlodipine as treatment for hypertension. Her asthma doctor prescribed Levalbuterol and Flovent Inhaler asthma. It was reported that the outcome of the events has not resolved. The medical history of remains a confounder Asthma. A fourth dose of the mRNA-1273 was given to this patient considering her Immunocompromised state with Breast Cancer with Chemotherapy. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.