Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Loss of consciousness, Lymphadenopathy, Physical examination, Presyncope
Clinical narrative: Patient felt semi unconcious/patient felt out of place/The patient felt out of place and semi unconscious; Heart was out of rythymn; Resumed his cycling workouts he felt like he was going to faint; Nonstop chills; Fever; Fatigued; Headaches; Swollen lymph nodes in right armpit/ swollen lymph nodes in left armpit/had swollen lymph nodes in his right and left armpits; Symptoms of rapid breathing; Rapid heart beat after each dose; Symptoms were worse after his second dose; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Patient felt semi unconcious/patient felt out of place/The patient felt out of place and semi unconscious), ARRHYTHMIA (Heart was out of rythymn), PRESYNCOPE (Resumed his cycling workouts he felt like he was going to faint), TACHYPNOEA (Symptoms of rapid breathing) and TACHYCARDIA (Rapid heart beat after each dose) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced TACHYPNOEA (Symptoms of rapid breathing), TACHYCARDIA (Rapid heart beat after each dose) and CONDITION AGGRAVATED (Symptoms were worse after his second dose). On 30-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Patient felt semi unconcious/patient felt out of place/The patient felt out of place and semi unconscious), ARRHYTHMIA (Heart was out of rythymn), PRESYNCOPE (Resumed his cycling workouts he felt like he was going to faint), CHILLS (Nonstop chills), PYREXIA (Fever), FATIGUE (Fatigued), HEADACHE (Headaches) and LYMPHADENOPATHY (Swollen lymph nodes in right armpit/ swollen lymph nodes in left armpit/had swollen lymph nodes in his right and left armpits). In April 2021, TACHYPNOEA (Symptoms of rapid breathing), TACHYCARDIA (Rapid heart beat after each dose) and CONDITION AGGRAVATED (Symptoms were worse after his second dose) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (Patient felt semi unconcious/patient felt out of place/The patient felt out of place and semi unconscious), ARRHYTHMIA (Heart was out of rythymn), PRESYNCOPE (Resumed his cycling workouts he felt like he was going to faint), CHILLS (Nonstop chills), PYREXIA (Fever), FATIGUE (Fatigued), HEADACHE (Headaches) and LYMPHADENOPATHY (Swollen lymph nodes in right armpit/ swollen lymph nodes in left armpit/had swollen lymph nodes in his right and left armpits) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, Physical examination: normal (normal) Everything was fine. On an unknown date, Antibody test: negative (Negative) It showed that the patient had no antibodies to COVID-19.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received the vaccine in his right arm shoulder deltoid muscle.  The patient was a cyclist and when he resumed his cycling workouts he felt like he was going to faint and that his heart was out of rhythm. The patient had symptoms of rapid breathing and rapid heart beat after each dose. Symptoms were worse after his second dose. The symptoms resolved few days after the second dose.  No concomitant product use was provided by the reporter.   No treatment medications were reported.  Company Comment: This case concerns a 34-year-old male patient, with no medical history reported, who experienced the unexpected events of Loss of consciousness (AESI), Arrhythmia (AESI), Dyspnea, Tachypnea, Tachycardia, Pre-syncope, and the expected events of Chills, Pyrexia, Fatigue, Headache and Lymphadenopathy. The events occurred on the same day after receiving the second dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was unknown. The rechallenge is not applicable since no further dosing is expected. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-442104 (Patient Link).; Sender's Comments: This case concerns a 34-year-old male patient, with no medical history reported, who experienced the unexpected events of Loss of consciousness (AESI), Arrhythmia (AESI), Dyspnea, Tachypnea, Tachycardia, Pre-syncope, and the expected events of Chills, Pyrexia, Fatigue, Headache and Lymphadenopathy. The events occurred on the same day after receiving the second dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was unknown. The rechallenge is not applicable since no further dosing is expected. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.