Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Gait disturbance, Glycosylated haemoglobin, Headache
Clinical narrative: Almost passed out on the shower; Cardiac arrest and thought had stroke; Bipolar; Panic attack; Nausea; Almost passed out on the shower/collapsed on the bed; Tachycardia; Can't eat; Vomiting; Respiratory symptoms; Diagnosed with musculoskeletal disease; Tingling feeling; Feet are swollen, like balloons; feels like is going to die /brain fog; Very exhausted; Muscle pain; Can't walk; blisters on the balls of the feet / feet in the back they were like balloons, the whole area; Joint pain/knee very painful; Pain all over the her body/so much pain and agony / very painful to proceed; Headache; Chills; Fever; This spontaneous case was reported by a physician and describes the occurrence of CARDIAC ARREST (Cardiac arrest and thought had stroke) and LOSS OF CONSCIOUSNESS (Almost passed out on the shower/collapsed on the bed) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 312858, MOD 040A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee replacement (had knee replacement 2x).   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever). On 28-Oct-2021, the patient experienced GAIT DISTURBANCE (Can't walk), BLISTER (blisters on the balls of the feet / feet in the back they were like balloons, the whole area), PAIN (Pain all over the her body/so much pain and agony / very painful to proceed), ARTHRALGIA (Joint pain/knee very painful) and MYALGIA (Muscle pain). On 09-Nov-2021, the patient experienced RESPIRATORY SYMPTOM (Respiratory symptoms) and MUSCULOSKELETAL DISORDER (Diagnosed with musculoskeletal disease). On 12-Nov-2021, the patient experienced LOSS OF CONSCIOUSNESS (Almost passed out on the shower/collapsed on the bed) (seriousness criterion medically significant), TACHYCARDIA (Tachycardia), DECREASED APPETITE (Can't eat), NAUSEA (Nausea) and VOMITING (Vomiting). On 14-Nov-2021, the patient experienced CARDIAC ARREST (Cardiac arrest and thought had stroke) (seriousness criterion medically significant), BIPOLAR DISORDER (Bipolar) and PANIC ATTACK (Panic attack). In November 2021, the patient experienced PARAESTHESIA (Tingling feeling), PERIPHERAL SWELLING (Feet are swollen, like balloons), FEELING ABNORMAL (feels like is going to die /brain fog) and FATIGUE (Very exhausted). On an unknown date, the patient experienced PRESYNCOPE (Almost passed out on the shower). The patient was treated with LIDOCAINE for Adverse event, at an unspecified dose and frequency and PREDNISONE for Adverse event, at a dose of 3 pills for 5 days. On 27-Oct-2021, PYREXIA (Fever) had resolved. At the time of the report, CARDIAC ARREST (Cardiac arrest and thought had stroke), LOSS OF CONSCIOUSNESS (Almost passed out on the shower/collapsed on the bed), PRESYNCOPE (Almost passed out on the shower), GAIT DISTURBANCE (Can't walk), BLISTER (blisters on the balls of the feet / feet in the back they were like balloons, the whole area), RESPIRATORY SYMPTOM (Respiratory symptoms), MUSCULOSKELETAL DISORDER (Diagnosed with musculoskeletal disease), TACHYCARDIA (Tachycardia), DECREASED APPETITE (Can't eat), PARAESTHESIA (Tingling feeling), PERIPHERAL SWELLING (Feet are swollen, like balloons), FEELING ABNORMAL (feels like is going to die /brain fog), BIPOLAR DISORDER (Bipolar), PANIC ATTACK (Panic attack), PAIN (Pain all over the her body/so much pain and agony / very painful to proceed), NAUSEA (Nausea), ARTHRALGIA (Joint pain/knee very painful), VOMITING (Vomiting), MYALGIA (Muscle pain) and FATIGUE (Very exhausted) outcome was unknown and HEADACHE (Headache) and CHILLS (Chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Oct-2021, Ultrasound scan: normal (normal) went to the ultrasound to rule out DVT (deep vein thrombosis - cleared). On 09-Nov-2021, Antibody test: negative (Negative) Negative. On 09-Nov-2021, Blood test: normal (normal) Normal. On 09-Nov-2021, Culture throat: negative (Negative) swab tests-negative. On 09-Nov-2021, Urine analysis: normal (normal) Normal. On 12-Nov-2021, Blood test: normal (normal) Normal. On 12-Nov-2021, Heart rate: 130/bpm (High) Tachycardia. On 12-Nov-2021, Ventilation/perfusion scan: abnormal (abnormal) it rule out lung clotting. In November 2021, Blood pressure measurement: abnormal (abnormal) Blood pressure is back up. In November 2021, Glycosylated haemoglobin: 6.14 (abnormal) Abnormal. In November 2021, Vitamin D: 23 (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On November 9 to November 11, patient felt crippled and couldn't sleep because of the symptoms. Treatment included hot massage and warm compress on her legs, muscle relaxant cream, pain killer and muscle relaxant. On 12 Nov the patient had nausea and vomiting, almost passed out on the shower -  had tachycardia 130/bpm - didn't want to go to hospital, couldn't eat  -collapsed on the bed, stayed on the ER and thought there is something on her lungs and had lung scan but it rule out lung clotting Patient was self-medicating and taking heart and BP medications. Lab data included ECG, blood work and ECHO done on 15 Nov 2021. Patient went to hospital 5 times. caller called pressured speech, rambling speech, flights of ideas, disorganized thoughts/speech. Going from laughter to sobbing & crying profusely, to happy state of mind. This case concerns a 69-year-old, female patient with no relevant medical history reported, who experienced the unexpected serious events of Myocardial infarction, and Loss of consciousness which occurred approximately 18 and 16 days after the third dose of mRNA-1273, respectively along with other non serious events. It was reported that the patient had nausea and vomiting almost passed out on the shower. The patient had tachycardia 130/bpm  and didn't want to go to hospital, couldn't eat and collapsed on the bed, after which the patient stayed on the ER where lung clotting was ruled out. Two days later the patient reported cardiac arrest and thought she had stroke and called her cardiologist but wasn't able to reach her. As reported by the patient, patient's doctor also think she is bipolar and having panic attacks. The rechallenge was not applicable as events occurred after third dose and no further dosing was reported or planned, based on information provided. It is unclear if the patient had myocardial infarction as no information on treatment or diagnostic findings was provided. It was also reported that patient's physician considers the    Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2021: Follow Up information was received on 17-Nov-2021 Added lab data, added events. On 19-Nov-2021: Follow Up information was received on 19-Nov-2021 Added lab data, added events; Sender's Comments: This case concerns a 69-year-old, female patient with no relevant medical history reported, who experienced the unexpected serious events of Myocardial infarction, and Loss of consciousness which occurred approximately 18 and 16 days after the third dose of mRNA-1273, respectively along with other non serious events. It was reported that the patient had nausea and vomiting almost passed out on the shower. The patient had tachycardia 130/bpm  and didn't want to go to hospital, couldn't eat and collapsed on the bed, after which the patient stayed on the ER where lung clotting was ruled out. Two days later the patient reported cardiac arrest and thought she had stroke and called her cardiologist but wasn't able to reach her. As reported by the patient, patient's doctor also think she is bipolar and having panic attacks. The rechallenge was not applicable as events occurred after third dose and no further dosing was reported or planned, based on information provided. It is unclear if the patient had myocardial infarction as no information on treatment or diagnostic findings was provided. It was also reported that patient's physician considers the patient bipolar and was thinking the patient was having panic attack which could provide explanation for patient thinking about having stroke or myocardial infarction. It is likely the patient has bipolar disorder as per last follow up information the patient was having pressured speech, rambling speech, flights of ideas, disorganized thoughts/speech, going from laughter to sobbing and crying profusely, to happy state of mind. Bipolar disorder was captured as an event until further clarification. The benefit-risk relationship of mRNA-1273 is not affected by this report.