Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Fatigue, Headache, Heart rate, Heart rate irregular
Clinical narrative: migraine type headache; fatigue/fatigue on exertion; dizziness; Headache/ Increased headache; nausea; hypertension; wheezing; heart racing with palpitations; chest tightness,feeling chest pressure; shortness of breath/worsening shortness of breath; Possible Atrial Fibrillation; This spontaneous case was reported by a nurse and describes the occurrence of ATRIAL FIBRILLATION (Possible Atrial Fibrillation) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H2H) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 09-Jan-2021. Previously administered products included for COVID-19 vaccination: Pfizer 1 (Pfizer 1 and 2 - Reactions (Patient experienced severe headache, nausea, heart racing with palpitations, hypertension, wheezing after Pfizer doses).) in March 2021, Pfizer 2 (Pfizer 1 and 2 - Reactions (Patient experienced severe headache, nausea, heart racing with palpitations, hypertension and wheezing after Pfizer doses).) in April 2021; for Product used for unknown indication: Flu Vaccine (Patient experienced severe headache, nausea, heart racing with palpitations, hypertension and wheezing after flu shot). Past adverse reactions to the above products included Adverse reaction with Flu Vaccine, Pfizer 1 and Pfizer 2. Concurrent medical conditions included Irritable bowel syndrome since 1995, Hypertension (Hypertension dx after Covid Vaccine 3/2021), Asthma since 1980, Allergy to vaccine (Flu Vaccine), Allergy to vaccine (Pfizer 1) and Allergy to vaccine (Pfizer 2). Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma, CHLOROTHIAZIDE (DIURIL [CHLOROTHIAZIDE]) from 12-Oct-2021 to an unknown date for Hypertension.    On 25-Jan-2022 at 1:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In January 2022, the patient experienced ATRIAL FIBRILLATION (Possible Atrial Fibrillation) (seriousness criterion medically significant). On 25-Jan-2022, the patient experienced CHEST DISCOMFORT (chest tightness,feeling chest pressure) and DYSPNOEA (shortness of breath/worsening shortness of breath). On 25-Jan-2022 at 1:35 PM, the patient experienced HYPERTENSION (hypertension), WHEEZING (wheezing), PALPITATIONS (heart racing with palpitations), DIZZINESS (dizziness), HEADACHE (Headache/ Increased headache) and NAUSEA (nausea). On 28-Jan-2022, the patient experienced FATIGUE (fatigue/fatigue on exertion). On 31-Jan-2022, the patient experienced MIGRAINE (migraine type headache). The patient was treated with ALBUTEROL [SALBUTAMOL] on 25-Jan-2022 for Wheezing and Shortness of breath, at a dose of 2 puffs and IBUPROFEN for Headache, at a dose of 200 milligram. At the time of the report, ATRIAL FIBRILLATION (Possible Atrial Fibrillation), CHEST DISCOMFORT (chest tightness,feeling chest pressure) and DYSPNOEA (shortness of breath/worsening shortness of breath) outcome was unknown and HYPERTENSION (hypertension), WHEEZING (wheezing), PALPITATIONS (heart racing with palpitations), MIGRAINE (migraine type headache), DIZZINESS (dizziness), HEADACHE (Headache/ Increased headache), NAUSEA (nausea) and FATIGUE (fatigue/fatigue on exertion) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2022, Blood pressure measurement: 154/95 (High) 154/95. On 25-Jan-2022, Oxygen saturation: 97-99 (normal) 97-99%. On 25-Jan-2022, Vital signs measurement: stable (normal) BP elevated at 154/95; rest of the vitals were stable. On 28-Jan-2022, Heart rate irregular: increased irregular beats (abnormal) increased irregular beats. On 31-Jan-2022, Electrocardiogram: nsr with pacs only on exertion (normal) NSR with PACs only on exertion. On an unknown date, Blood pressure measurement: 170/117 (High) Initial BP in Emergency Room was 170/117. On an unknown date, Electrocardiogram: nsr with pacs (normal) NSR with PACs and possible atrial fibrillation (abnormal) ECG in Emergency Room showed signs of possible Atrial Fibrillation after potassium IV changed to PACs. On an unknown date, Heart rate: 80 (normal) 80. On an unknown date, Heart rate irregular: abnormal (abnormal) abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered HYPERTENSION (hypertension), WHEEZING (wheezing), PALPITATIONS (heart racing with palpitations), HEADACHE (Headache/ Increased headache) and NAUSEA (nausea) to be related. No further causality assessments were provided for ATRIAL FIBRILLATION (Possible Atrial Fibrillation), MIGRAINE (migraine type headache), CHEST DISCOMFORT (chest tightness,feeling chest pressure), DYSPNOEA (shortness of breath/worsening shortness of breath), DIZZINESS (dizziness) and FATIGUE (fatigue/fatigue on exertion).    Patient height was reported as 5'6.8 and weight was reported as 134 pounds.  Patient took Pfizer first dose on 3/2021 and  second dose on  4/2021.  There were no acute illnesses at the time of vaccination and up to one month before.  It was unknown whether any other potential causes for the events (Severe Headache, nausea, heart racing with palpitations, hypertension, wheezing).  Reported that after 2 minutes of vaccination, patient had headache, nausea, dizziness. Within 10 minutes chest tightness, and shortness of breath and BP elevated at 154/95; rest of the vitals were stable. Patient started having wheezing and worsening shortness of breath, PACs 1hr after vaccination, so 2 puffs albuterol was given. Albuterol did not provide any relief. O2 saturation was normal at 97-99% during entire observation period.    Company comment: This spontaneous case concerns a 67-year-old female patient with history of Asthma, Hypertension, interchange of vaccine products (Pfizer Covid 19 vaccine), and allergy to vaccines (Pfizer Covid19 and Flu), experienced the unexpected serious AESI event Atrial fibrillation which occurred within five minutes of a dose of mRNA-1273(given as a third dose). The patient developed possible atrial fibrillation, migraine like headache, nausea, dizziness, chest tightness, and shortness of breath, and BP elevated. At the time of reporting the event outcome was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 67-year-old female patient with history of Asthma, Hypertension, interchange of vaccine products (Pfizer Covid 19 vaccine), and allergy to vaccines (Pfizer Covid19 and Flu), experienced the unexpected serious AESI event Atrial fibrillation which occurred within five minutes of a dose of mRNA-1273(given as a third dose). The patient developed possible atrial fibrillation, migraine like headache, nausea, dizziness, chest tightness, and shortness of breath, and BP elevated. At the time of reporting the event outcome was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.