Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash, Syncope, Tachycardia
Clinical narrative: Angina pectoris; When goes to wave, almost fell/Collapsed twice; dyspnoea exertional; lethargy; Painful respiration; chest discomfort; Unknown rash going up both arm.; Date of positive COVID-19 test: 09Dec2021; Sprained both ankles; On loop recorder, showed heart ratewent from 200 bpm and shut off then restarted 7 seconds later/Went to ER and her heart stopped; swelling in legs; Started getting pins and needles all up and down arm; still dizzy; Now has bradycardia; low blood pressure/dropped to 80/30; Since getting the Moderna vaccine, had 3 episodes of syncope or near-syncope/while going up stairs, looks down and collapsed/Collapsed twice/First syncope event/Turned a gray color and then her color came back ~15 minutes later; High blood pressure/high/Blood pressure was 115-125/60; Palpitations; if walk any length of time, out of breath/still short of breath; Feels like a bobble head; Itting in truck and goes from freezing to sweating; Rapid headache; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ANGINA PECTORIS (Angina pectoris), BRADYCARDIA (Now has bradycardia), HYPOTENSION (low blood pressure/dropped to 80/30) and SYNCOPE (Since getting the Moderna vaccine, had 3 episodes of syncope or near-syncope/while going up stairs, looks down and collapsed/Collapsed twice/First syncope event/Turned a gray color and then her color came back ~15 minutes later) in a 58-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.     The patient's past medical history included Defibrillator/pacemaker insertion (has a pacemaker/defibrillator.). Previously administered products included for Product used for unknown indication: flu vaccine (bad reaction to flu vaccine. 8 or 10 years ago and got the flu vaccine and had a bad reaction to the "old version" of the flu vaccine.). Past adverse reactions to the above products included Adverse reaction with flu vaccine. Concomitant products included OMEPRAZOLE, LEVOTHYROXINE, LOSARTAN, AMBROXOL HYDROCHLORIDE, CLENBUTEROL HYDROCHLORIDE (NADOL [AMBROXOL HYDROCHLORIDE;CLENBUTEROL HYDROCHLORIDE]) and MELOXICAM for an unknown indication.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jul-2021, the patient experienced HYPERHIDROSIS (Itting in truck and goes from freezing to sweating) and HEADACHE (Rapid headache). On 28-Jul-2021, the patient experienced BRADYCARDIA (Now has bradycardia) (seriousness criterion medically significant), HYPOTENSION (low blood pressure/dropped to 80/30) (seriousness criterion medically significant), SYNCOPE (Since getting the Moderna vaccine, had 3 episodes of syncope or near-syncope/while going up stairs, looks down and collapsed/Collapsed twice/First syncope event/Turned a gray color and then her color came back ~15 minutes later) (seriousness criterion medically significant), HYPERTENSION (High blood pressure/high/Blood pressure was 115-125/60), PALPITATIONS (Palpitations), DYSPNOEA (if walk any length of time, out of breath/still short of breath), FEELING ABNORMAL (Feels like a bobble head), LIGAMENT SPRAIN (Sprained both ankles), TACHYCARDIA (On loop recorder, showed heart ratewent from 200 bpm and shut off then restarted 7 seconds later/Went to ER and her heart stopped), PERIPHERAL SWELLING (swelling in legs), PARAESTHESIA (Started getting pins and needles all up and down arm) and DIZZINESS (still dizzy). On an unknown date, the patient experienced ANGINA PECTORIS (Angina pectoris) (seriousness criterion medically significant), FALL (When goes to wave, almost fell/Collapsed twice), DYSPNOEA EXERTIONAL (dyspnoea exertional), LETHARGY (lethargy), PAINFUL RESPIRATION (Painful respiration), CHEST DISCOMFORT (chest discomfort), RASH (Unknown rash going up both arm.) and COVID-19 (Date of positive COVID-19 test: 09Dec2021). At the time of the report, ANGINA PECTORIS (Angina pectoris), BRADYCARDIA (Now has bradycardia), HYPOTENSION (low blood pressure/dropped to 80/30), SYNCOPE (Since getting the Moderna vaccine, had 3 episodes of syncope or near-syncope/while going up stairs, looks down and collapsed/Collapsed twice/First syncope event/Turned a gray color and then her color came back ~15 minutes later), HYPERTENSION (High blood pressure/high/Blood pressure was 115-125/60), PALPITATIONS (Palpitations), DYSPNOEA (if walk any length of time, out of breath/still short of breath), FEELING ABNORMAL (Feels like a bobble head), HYPERHIDROSIS (Itting in truck and goes from freezing to sweating), LIGAMENT SPRAIN (Sprained both ankles), TACHYCARDIA (On loop recorder, showed heart ratewent from 200 bpm and shut off then restarted 7 seconds later/Went to ER and her heart stopped), PERIPHERAL SWELLING (swelling in legs), FALL (When goes to wave, almost fell/Collapsed twice), DYSPNOEA EXERTIONAL (dyspnoea exertional), LETHARGY (lethargy), PAINFUL RESPIRATION (Painful respiration), CHEST DISCOMFORT (chest discomfort), PARAESTHESIA (Started getting pins and needles all up and down arm), DIZZINESS (still dizzy), RASH (Unknown rash going up both arm.), HEADACHE (Rapid headache) and COVID-19 (Date of positive COVID-19 test: 09Dec2021) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 15-125/60 15-125/60, 80/30 dropped to 80/30., 167/107 167/107, high high and low bp low bp. On an unknown date, Heart rate: 200 bpm 200 bpm and shut off and restarted restarted 7 seconds later.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment:  This spontaneous case concerns a 58-year-old female patient with no relevant medical history, who experienced the unexpected serious (medically significant) adverse events of Syncope, Angina pectoris, Bradycardia, Hypotension, and unexpected non-serious adverse event of special interest COVID-19.  The events Syncope, Bradycardia, and Hypotension occurred 3 months after receiving 2nd dose of mRNA-1273 vaccine.  The event Angina pectoris occurred on an unknown date, and COVID-19 occurred 7 months and 11 days after administration of the same dose of vaccine.  Patient experienced 3 episodes of syncope associated with drop in blood pressure to 80/30 mmHg, palpitations, shortness of breath, dizziness and pins and needles of the arm.  Patient had 4 emergency room visits and was put on loop recorder which at one point showed a heart rate of 200 bpm.  Patient subsequently underwent pacemaker/defibrillator insertion. Patient previously received first dose of mRNA-1273 vaccines in the month prior to current mRNA-1273 vaccine (interval cannot be established). The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-572767, MOD-2022-572790 (Patient Link).; Sender's Comments: This spontaneous case concerns a 58-year-old female patient with no relevant medical history, who experienced the unexpected serious (medically significant) adverse events of Syncope, Angina pectoris, Bradycardia, Hypotension, and unexpected non-serious adverse event of special interest COVID-19.  The events Syncope, Bradycardia, and Hypotension occurred 3 months after receiving 2nd dose of mRNA-1273 vaccine.  The event Angina pectoris occurred on an unknown date, and COVID-19 occurred 7 months and 11 days after administration of the same dose of vaccine.  Patient experienced 3 episodes of syncope associated with drop in blood pressure to 80/30 mmHg, palpitations, shortness of breath, dizziness and pins and needles of the arm.  Patient had 4 emergency room visits and was put on loop recorder which at one point showed a heart rate of 200 bpm.  Patient subsequently underwent pacemaker/defibrillator insertion. Patient previously received first dose of mRNA-1273 vaccine in the month prior to current mRNA-1273 vaccine (interval cannot be established). The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.