Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Dyspnoea, Electrocardiogram, Heart rate, Heart sounds
Clinical narrative: Possible pericarditis; Tight chest; Sore throat; Chest pain; Sinus bradycardia; Laryngitis; Hypertension; Hoarseness/Hoarse voice/Loss of voice; Throat swelling; Palpitation; Shortness of breath; Burning sensation; This spontaneous case was reported by a physician and describes the occurrence of PERICARDITIS (Possible pericarditis) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Gastritis on 17-Apr-2020, Trigeminal neuralgia and Obstructive sleep apnea syndrome. Concurrent medical conditions included Hypertension, Hyperlipidemia since 21-Jul-2015, GERD since 31-Mar-2020 and Drug allergy (History of intolerance to multiple medications. Blood pressure test kit-adult extra large cuff.). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), LORATADINE (CLARITIN [LORATADINE]), COLCHICINE (MITIGARE) and OSELTAMIVIR PHOSPHATE for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced PHARYNGEAL SWELLING (Throat swelling), PALPITATIONS (Palpitation), DYSPNOEA (Shortness of breath) and BURNING SENSATION (Burning sensation). On 21-Jan-2021, the patient experienced DYSPHONIA (Hoarseness/Hoarse voice/Loss of voice). In February 2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), CHEST PAIN (Chest pain), SINUS BRADYCARDIA (Sinus bradycardia), LARYNGITIS (Laryngitis) and HYPERTENSION (Hypertension). On an unknown date, the patient experienced PERICARDITIS (Possible pericarditis) (seriousness criterion medically significant) and CHEST DISCOMFORT (Tight chest). In February 2021, PERICARDITIS (Possible pericarditis), CHEST DISCOMFORT (Tight chest), DYSPHONIA (Hoarseness/Hoarse voice/Loss of voice), PHARYNGEAL SWELLING (Throat swelling), PALPITATIONS (Palpitation), DYSPNOEA (Shortness of breath), BURNING SENSATION (Burning sensation), OROPHARYNGEAL PAIN (Sore throat), CHEST PAIN (Chest pain), SINUS BRADYCARDIA (Sinus bradycardia), LARYNGITIS (Laryngitis) and HYPERTENSION (Hypertension) had resolved with sequelae.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Electrocardiogram: normal (normal) normal. In January 2021, Oxygen saturation: 98-99 (normal) 98-99. In January 2021, Physical examination: normal (normal) normal. On 17-Feb-2021, Blood pressure measurement: 149/62. On 17-Feb-2021, Chest X-ray: normal. On 17-Feb-2021, Electrocardiogram: Showed sinus bradycardia. On 17-Feb-2021, Heart rate: 59 (Inconclusive) 59. On 17-Feb-2021, Heart sounds: (normal) Regular rate and rhythm with normal S1 and S2. No murmur, pericardial rub.. On 17-Feb-2021, Physical examination: normal (normal) normal. On 24-Feb-2021, Blood pressure measurement: 130/58. On 24-Feb-2021, Heart rate: 53 (Inconclusive) 53. On 24-Feb-2021, Heart sounds: (normal) Regular rate and rhythm with normal S1 and S2. No murmur, pericardial rub.. On 03-Mar-2021, Blood pressure measurement: 133/54. On 03-Mar-2021, Heart rate: 61 (Inconclusive) 61. On 03-Mar-2021, Heart sounds: Regular rate and rhythm with normal S1 and S2. No murmur, pericardial rub..     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PERICARDITIS (Possible pericarditis), CHEST DISCOMFORT (Tight chest), DYSPHONIA (Hoarseness/Hoarse voice/Loss of voice), PHARYNGEAL SWELLING (Throat swelling), PALPITATIONS (Palpitation), DYSPNOEA (Shortness of breath), BURNING SENSATION (Burning sensation), OROPHARYNGEAL PAIN (Sore throat), CHEST PAIN (Chest pain), SINUS BRADYCARDIA (Sinus bradycardia), LARYNGITIS (Laryngitis) and HYPERTENSION (Hypertension) to be probably related.    Treatment for the event included antibiotics, prednisone and colchicine. Medical Clinic Coordinator provided events were resolved in mid Feb 2021 with residual effects of hoarseness and tightness of chest.  Company comment Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities, further information required.   This case was linked to MOD-2021-046995 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Vaccine adverse event reporting form and medical records received.  Multiple fields updated.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities, further information required.