Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Pericarditis; Flu like symptoms; Dizziness like vertigo; Dizziness like vertigo; Balance issues; Blurry visions; Chest pain; Pain at his back; High blood pressure going crazy; Heart palpitation; Weakness; Car accident not long after the 1st dose; Shortness of breath; Difficulty sleeping; Felt he was getting worse; Difficult to do laundry/Difficult to do clean dishes/Difficult to do make dinner; 1st dose of the Moderna COVID 19 vaccine on 11MAR2021 & 2nd dose on 28MAY2021; Fatigue; Pain belowhis shoulder blade; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDITIS (Pericarditis) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERICARDITIS (Pericarditis) (seriousness criteria hospitalization and medically significant), INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS (Dizziness like vertigo), VERTIGO (Dizziness like vertigo), BALANCE DISORDER (Balance issues), VISION BLURRED (Blurry visions), CHEST PAIN (Chest pain), BACK PAIN (Pain at his back), HYPERTENSION (High blood pressure going crazy), PALPITATIONS (Heart palpitation), ASTHENIA (Weakness), ROAD TRAFFIC ACCIDENT (Car accident not long after the 1st dose), DYSPNOEA (Shortness of breath), INSOMNIA (Difficulty sleeping), FEELING ABNORMAL (Felt he was getting worse), MOBILITY DECREASED (Difficult to do laundry/Difficult to do clean dishes/Difficult to do make dinner), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of the Moderna COVID 19 vaccine on 11MAR2021 & 2nd dose on 28MAY2021), FATIGUE (Fatigue) and ARTHRALGIA (Pain belowhis shoulder blade). The patient was hospitalized from 26-Jun-2021 to 27-Jun-2021 due to PERICARDITIS. The patient was treated with IBUPROFEN for Pericarditis, at a dose of 1 dosage form and COLCHICINE at a dose of 0.6 mg. At the time of the report, PERICARDITIS (Pericarditis), INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS (Dizziness like vertigo), VERTIGO (Dizziness like vertigo), BALANCE DISORDER (Balance issues), VISION BLURRED (Blurry visions), CHEST PAIN (Chest pain), BACK PAIN (Pain at his back), HYPERTENSION (High blood pressure going crazy), PALPITATIONS (Heart palpitation), ASTHENIA (Weakness), ROAD TRAFFIC ACCIDENT (Car accident not long after the 1st dose), DYSPNOEA (Shortness of breath), INSOMNIA (Difficulty sleeping), FEELING ABNORMAL (Felt he was getting worse), MOBILITY DECREASED (Difficult to do laundry/Difficult to do clean dishes/Difficult to do make dinner), FATIGUE (Fatigue) and ARTHRALGIA (Pain belowhis shoulder blade) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of the Moderna COVID 19 vaccine on 11MAR2021 & 2nd dose on 28MAY2021) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) High. On an unknown date, Heart rate: abnormal (abnormal) Pulse - Abnormal.         No concomitant product information was provided.  Patient stated that he received his 1st dose of the Moderna COVID 19 vaccine on 11MAR2021 at grocery store and his 2nd dose on 28MAY2021 at supermarket. He did not receive his 2nd dose on the scheduled day because he got into a car accident not long after the 1st dose. He had flu like symptoms after the 2nd dose. Two weeks later, he started having other symptoms. These symptoms include dizziness like vertigo, balance issues, pulse issue related to his heart rate, blurry visions, chest pain, pain at his back, pain below his shoulder blade, high blood pressure going crazy, heart palpitation, shortness of breath, difficulty sleeping, weakness, and fatigue. On 26JUN2021, he went to the ER and was diagnosed with pericarditis. He spent the night in the hospital 26/27JJUN2021 and was discharged with Ibuprofen ON 27JUN2021. While at the hospital they did blood work and EKG to confirm that he was not having a heart attack. A week later he returned to the ER because he was not feeling better. He is not in a good place, he finds it difficult to do laundry, clean dishes or make dinner. He feels off and thinks he is getting worse and no one seems to be taking him serious. He does not have a primary care physician; he goes to a clinic and usually sees any doctor that is available. He is currently taking Ibuprofen and Colchicine 0.6 mg to help with the symptoms. He is still having the symptoms; he will be referred to a cardiologist. He regrets getting the 2nd dose. He gave consent for safety to follow-up with him.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. This also report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 with the associated AEs reported.   This case was linked to MOD-2021-266164 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. This also report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 with the associated AEs reported.