Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: Feeling weak; Lost appetite; EKG with skipping beatings/irregular heartbeat; Flu like symptoms; Felt cold and hot; This spontaneous case was reported by a patient and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Felt cold and hot), ASTHENIA (Feeling weak), DECREASED APPETITE (Lost appetite), EXTRASYSTOLES (EKG with skipping beatings) and HEART RATE IRREGULAR (Irregular heartbeat) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056ARCA, 004S21A, 023MCOA and 041LCOA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient had never diagnosed or tested positive for COVID.  Concurrent medical conditions included Penicillin allergy, Food allergy (Spicy food), Thyroid disorder (thyroid problems) and Palpitation (heart palpitations due to thyroid problems). Concomitant products included CALCIUM for Supplementation therapy, CILNIDIPINE, OLMESARTAN MEDOXOMIL (BENICAR), LEVOTHYROXINE SODIUM (SYNTHROID), ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN, PANTOPRAZOLE, METFORMIN, HYDROXYCARBAMIDE (HYDROXYUREA) and VITAMIN D NOS for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2022, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Felt cold and hot) and INFLUENZA LIKE ILLNESS (Flu like symptoms). On 20-Apr-2022, the patient experienced HEART RATE IRREGULAR (Irregular heartbeat). On 24-Apr-2022, the patient experienced EXTRASYSTOLES (EKG with skipping beatings). On an unknown date, the patient experienced ASTHENIA (Feeling weak) and DECREASED APPETITE (Lost appetite). The patient was treated with PARACETAMOL (TYLENOL) for Feeling hot and cold and Flu like symptoms, at an unspecified dose and frequency and IBUPROFEN for Feeling hot and cold and Flu like symptoms, at an unspecified dose and frequency. At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (Felt cold and hot), ASTHENIA (Feeling weak) and DECREASED APPETITE (Lost appetite) had not resolved and EXTRASYSTOLES (EKG with skipping beatings), HEART RATE IRREGULAR (Irregular heartbeat) and INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2022, Electrocardiogram: normal with some skip beatings (normal) normal with some skip beatings. On 24-Apr-2022, Myocardial necrosis marker: normal (normal) Normal. On an unknown date, Cardiac stress test: results not reported heart activity was monitored for 2 weeks (from 25-Apr-2022 to 08-May-2022).         Patient received the second booster dose of Moderna Covid-19 vaccine on 19-Apr-2022.  On 20-Apr-2022, patient experienced an irregular heartbeat. Since patient did not had the symptoms of a heart attack, patient did not visited the medical center. It was reported that on 24-Apr-2022 she visited the emergency room where they did an EKG which was normal with some skip beatings. Patient was discharged but was told to visit the cardiac stress lab and her heart activity was monitored for 2 weeks.  Company Comment: This is a spontaneous case concerning  a  78-year-old, female patient with Concurrent medical conditions of Thyroid disorder (thyroid problems) and Palpitation (heart palpitations due to thyroid problems), who experienced the unexpected non-serious events of Feeling of body temperature change, Asthenia, Decreased appetite, Extrasystoles, Influenza like illness. The events Feeling of body temperature change, Influenza like illness occurred on the same day after the fourth dose of mRNA-1273 COVID 19 Vaccine. The event Extra systole  occurred  5 days after the fourth dose of mRNA-1273 COVID 19 Vaccine. On an unknown date events Asthenia, Decreased appetite occurred on an unknown date.  Patients laboratory test showed ECG: normal with some skip beats, Myocardial Necrosis marker: normal. At the time of report the events  Feeling of body temperature change, Asthenia, Decreased appetite were reported as not resolved,  extra systole and Influenza like illness outcome was unknown. Patient was treated with Paracetamol and Ibuprofen at an unspecified dose and frequency. The Concurrent medical conditions of Thyroid disorder (thyroid problems) and Palpitation (heart palpitations due to thyroid problems) remains a confounder. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.   This case was linked to MOD-2022-569008, MOD-2022-569007, MOD-2022-569005 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2022: Follow-up received contains no new information; Sender's Comments: Company Comment: This is a spontaneous case concerning  a  78-year-old, female patient with Concurrent medical conditions of Thyroid disorder (thyroid problems) and Palpitation (heart palpitations due to thyroid problems), who experienced the unexpected non-serious events of Feeling of body temperature change, Asthenia, Decreased appetite, Extrasystoles, Influenza like illness. The events Feeling of body temperature change, Influenza like illness occurred on the same day after the fourth dose of mRNA-1273 COVID 19 Vaccine. The event Extra systole  occurred  5 days after the fourth dose of mRNA-1273 COVID 19 Vaccine. On an unknown date events Asthenia, Decreased appetite occurred on an unknown date.  Patients laboratory test showed ECG: normal with some skip beats, Myocardial Necrosis marker: normal. At the time of report the events  Feeling of body temperature change, Asthenia, Decreased appetite were reported as not resolved,  extra systole and Influenza like illness outcome was unknown. Patient was treated with Paracetamol and Ibuprofen at an unspecified dose and frequency. The Concurrent medical conditions of Thyroid disorder (thyroid problems) and Palpitation (heart palpitations due to thyroid problems) remains a confounder. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.