Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate, Palpitations, Presyncope
Clinical narrative: vaso-vagal; Rapid heartbeat with irregularity; did not feel right; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRESYNCOPE (vaso-vagal), PALPITATIONS (Rapid heartbeat with irregularity) and FEELING ABNORMAL (did not feel right) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 001A21A) for COVID-19 vaccination.     The patient's past medical history included Atrial flutter on 10-Mar-2020, Vasovagal symptoms and Cardiac ablation on 17-Apr-2020. Concurrent medical conditions included Penicillin allergy, Drug allergy (Allergic to aspirin), Hypertension since 10-Mar-2020 and Arthritis. Concomitant products included CHLORPHENAMINE MALEATE (CHLORTRIMETON) for Allergy, PARACETAMOL (TYLENOL ARTHRITIS) from 2021 to an unknown date for Arthritis, METOPROLOL from 2020 to an unknown date for Hypertension, ACICLOVIR SODIUM (ACYCLOVIR [ACICLOVIR SODIUM]), FISH OIL, CALCIUM and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 02-Feb-2021 at 9:40 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced PRESYNCOPE (vaso-vagal). 02-Feb-2021, the patient experienced PALPITATIONS (Rapid heartbeat with irregularity) and FEELING ABNORMAL (did not feel right). On 02-Feb-2021, PRESYNCOPE (vaso-vagal) and PALPITATIONS (Rapid heartbeat with irregularity) had resolved. At the time of the report, FEELING ABNORMAL (did not feel right) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2001, Heart rate: 94-96 heart beats per minute Inconclusive.         The patient consulted with her primary care physician who decided that her reactions were due to her history of presyncope.  No Treatment information for the event was provided.  The patient reported that she did not take anything to alleviate the symptoms; she just laid down and that helped.   Patient reported that she had no problems after taking the second dose.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Completed ADR Form received, added medical history, concomitant medications, event. Updated patient demographics, action taken, de-re-challenge, event outcome. On 05-Jul-2021: Event outcomes updated to recovered/resolved. This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Feb-2021. The most recent information was received on 05-Jul-2021 and was forwarded to Moderna on 05-Jul-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRESYNCOPE (vaso-vagal), PALPITATIONS (Rapid heartbeat with irregularity) and FEELING ABNORMAL (did not feel right) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 001A21A) for COVID-19 vaccination.     The patient's past medical history included Atrial flutter on 10-Mar-2020, Vasovagal symptoms and Cardiac ablation on 17-Apr-2020. Concurrent medical conditions included Penicillin allergy, Drug allergy (Allergic to aspirin), Hypertension since 10-Mar-2020 and Arthritis. Concomitant products included CHLORPHENAMINE MALEATE (CHLORTRIMETON) for Allergy, PARACETAMOL (TYLENOL ARTHRITIS) from 2021 to an unknown date for Arthritis, METOPROLOL from 2020 to an unknown date for Hypertension, ACICLOVIR SODIUM (ACYCLOVIR [ACICLOVIR SODIUM]), FISH OIL, CALCIUM and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 02-Feb-2021 at 9:40 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced PRESYNCOPE (vaso-vagal). 02-Feb-2021, the patient experienced PALPITATIONS (Rapid heartbeat with irregularity) and FEELING ABNORMAL (did not feel right). On 02-Feb-2021, PRESYNCOPE (vaso-vagal) and PALPITATIONS (Rapid heartbeat with irregularity) had resolved. At the time of the report, FEELING ABNORMAL (did not feel right) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2001, Heart rate: 94-96 heart beats per minute Inconclusive.         The patient consulted with her primary care physician who decided that her reactions were due to her history of presyncope.  No Treatment information for the event was provided.  The patient reported that she did not take anything to alleviate the symptoms; she just laid down and that helped.   Patient reported that she had no problems after taking the second dose.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Completed ADR Form received, added medical history, concomitant medications, event. Updated patient demographics, action taken, de-re-challenge, event outcome. On 05-Jul-2021: Event outcomes updated to recovered/resolved.