Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Insomnia, Limb discomfort
Clinical narrative: Unusual heart rate; brain fatigue/ severe brain fog; 1st dose: 01Jan2021. and dose: 27Feb2021. extreme fatigue; bradycardia; Felt like my leg were knocked out from under me; insomnia; This spontaneous case was reported by a consumer and describes the occurrence of BRADYCARDIA (bradycardia) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included TIA (Patient  had a TIA in Feb 2017 TIA due to blockages in 2 of my stints.) in February 2017.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced BRADYCARDIA (bradycardia) (seriousness criterion medically significant), LIMB DISCOMFORT (Felt like my leg were knocked out from under me), INSOMNIA (insomnia) and FATIGUE (extreme fatigue). On an unknown date, the patient experienced HEART RATE ABNORMAL (Unusual heart rate), FEELING ABNORMAL (brain fatigue/ severe brain fog) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: 01Jan2021. and dose: 27Feb2021.). At the time of the report, BRADYCARDIA (bradycardia), LIMB DISCOMFORT (Felt like my leg were knocked out from under me), INSOMNIA (insomnia) and FATIGUE (extreme fatigue) had not resolved and HEART RATE ABNORMAL (Unusual heart rate), FEELING ABNORMAL (brain fatigue/ severe brain fog) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: 01Jan2021. and dose: 27Feb2021.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram ambulatory: Holter monitor showed bradycardia & unusual heart rate.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported.  Patient had Received Previous COVID-19 vaccination 1st dose on 01-Jan-2021 with Lot no EL3247 and  2nd dose on 27-Feb-2021 with Lot no EL9266.  The EEG and MRI performed with unknown result.    No treatment medication information was reported.  Company comment-This spontaneous case concerns a male patient aged 62 years with medical history of TIA in Feb 2017, who experienced the serious (medically significant) unexpected event of Bradycardia which occurred on the same day after the initial booster dose of mRNA-1273 vaccine administration. Patient also had unexpected non-serious events of Fatigue, Limb discomfort, Insomnia, Feeling Abnormal and Heart rate abnormal. Additionally Inappropriate schedule of product administration was noted as patient had received initial two doses of mRNA-1273 vaccine at an interval of about 57 days. EEG and MRI was done reports not available. Holter monitor showed bradycardia & unusual heart rate. No further information on risk factors, concurrent illness, detailed clinical course, investigations, treatment of the events was available in the report. The outcome of the event Bradycardia was reported as not resolved. It was reported that patient had a TIA in Feb 2017, TIA due to blockages in 2 of his stents, could be indicative of the underlying medical condition(cardiac disease) and remains a confounder.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a male patient aged 62 years with medical history of TIA in Feb 2017, who experienced the serious (medically significant) unexpected event of Bradycardia which occurred on the same day after the initial booster dose of mRNA-1273 vaccine administration. Patient also had unexpected non-serious events of Fatigue, Limb discomfort, Insomnia, Feeling Abnormal and Heart rate abnormal. Additionally Inappropriate schedule of product administration was noted as patient had received initial two doses of mRNA-1273 vaccine at an interval of about 57 days. EEG and MRI was done reports not available. Holter monitor showed bradycardia & unusual heart rate. No further information on risk factors, concurrent illness, detailed clinical course, investigations, treatment of the events was available in the report. The outcome of the event Bradycardia was reported as not resolved. It was reported that patient had a TIA in Feb 2017, TIA due to blockages in 2 of his stents, could be indicative of the underlying medical condition(cardiac disease) and remains a confounder.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.