Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Impaired quality of life, Inflammation, Malaise, Myalgia
Clinical narrative: severe abdominal  gastrointestinal inflammation persistent; develop a heart murmur/got diagnose with the heart murmur; had  a super ventricular taquicardia; neurological issues; persistent visual impairment/sees start going through field of vision/huge blind spot in the vision of field; persistent lung pleurisy; malaise; feel like is burning; persistent headache; pain in  the muscle  all over the body; persistent exhaustion; inflation of the lung; massive inflation of the body/basically caused  inflammation all over his body; couldn't get out of bed for 4 days; many adverse event that destroy his quality of life; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL INFLAMMATION (severe abdominal  gastrointestinal inflammation persistent), CARDIAC MURMUR (develop a heart murmur/got diagnose with the heart murmur), SUPRAVENTRICULAR TACHYCARDIA (had  a super ventricular taquicardia), NEUROLOGICAL SYMPTOM (neurological issues), VISUAL IMPAIRMENT (persistent visual impairment/sees start going through field of vision/huge blind spot in the vision of field), IMPAIRED QUALITY OF LIFE (many adverse event that destroy his quality of life), PNEUMONITIS (inflation of the lung) and PLEURISY (persistent lung pleurisy) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011f21a and 014f21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pericarditis (No cause found and was Hospitalized on 24 Dec 2018 to 25 Dec 2018) in December 2018. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LIOTHYRONINE and ANAKINRA for an unknown indication.   On 02-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced IMPAIRED QUALITY OF LIFE (many adverse event that destroy his quality of life) (seriousness criterion medically significant), INFLAMMATION (massive inflation of the body/basically caused  inflammation all over his body) and BEDRIDDEN (couldn't get out of bed for 4 days). On 31-Oct-2021, the patient experienced GASTROINTESTINAL INFLAMMATION (severe abdominal  gastrointestinal inflammation persistent) (seriousness criterion medically significant), CARDIAC MURMUR (develop a heart murmur/got diagnose with the heart murmur) (seriousness criterion medically significant), SUPRAVENTRICULAR TACHYCARDIA (had  a super ventricular taquicardia) (seriousness criterion medically significant), NEUROLOGICAL SYMPTOM (neurological issues) (seriousness criterion medically significant), VISUAL IMPAIRMENT (persistent visual impairment/sees start going through field of vision/huge blind spot in the vision of field) (seriousness criterion medically significant), PNEUMONITIS (inflation of the lung) (seriousness criterion medically significant), PLEURISY (persistent lung pleurisy) (seriousness criterion medically significant), MALAISE (malaise), FEELING HOT (feel like is burning), HEADACHE (persistent headache), MYALGIA (pain in  the muscle  all over the body) and FATIGUE (persistent exhaustion). The patient was treated with APIXABAN (ELIQUIS) at an unspecified dose and frequency; DILTIAZEM (CARDIZEM [DILTIAZEM]) at an unspecified dose and frequency; PREDNISONE at an unspecified dose and frequency and Surgery (shock heart to get back to rhythm back) for Supraventricular tachycardia. At the time of the report, GASTROINTESTINAL INFLAMMATION (severe abdominal  gastrointestinal inflammation persistent), CARDIAC MURMUR (develop a heart murmur/got diagnose with the heart murmur), SUPRAVENTRICULAR TACHYCARDIA (had  a super ventricular taquicardia), NEUROLOGICAL SYMPTOM (neurological issues), VISUAL IMPAIRMENT (persistent visual impairment/sees start going through field of vision/huge blind spot in the vision of field), IMPAIRED QUALITY OF LIFE (many adverse event that destroy his quality of life), PNEUMONITIS (inflation of the lung), INFLAMMATION (massive inflation of the body/basically caused  inflammation all over his body), PLEURISY (persistent lung pleurisy), MALAISE (malaise), FEELING HOT (feel like is burning), HEADACHE (persistent headache), MYALGIA (pain in  the muscle  all over the body) and FATIGUE (persistent exhaustion) had not resolved and BEDRIDDEN (couldn't get out of bed for 4 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported he had many adverse event that destroyed his quality of life and everything still had persistent. Patient had to shock the heart to get back to rhythm back and was diagnosed with Heart Murmur on 23 Nov 2021.  Company comment: This Spontaneous case concerns a 49-year-old, male patient, with medical history of pericarditis, who experienced the unexpected, serious (medically significant) events of impaired quality of life, cardiac murmur, gastrointestinal inflammation, neurological symptom, visual impairment, pleurisy, pneumonitis and AESI supraventricular tachycardia. The patient had many adverse events that destroy his quality of life as he couldn't get out of bed for 4 days after receiving the second dose of mRNA-1273 vaccine. He reported a massive inflation of the body in the fourth day and also developed supraventricular tachycardia that required cardioversion to get back to rhythm. Evolved with a heart murmur, severe abdominal  gastrointestinal inflammation and  also   neurological issues that were not specified along with myalgia, feeling of burning,  visual impairment, persistent  headache, persistent lung pleurisy, inflation of the lung, exhaustion and malaise. The rechallenge was not applicable, as no additional dose information was disclosed. The medical history of pericarditis remains as a confounder. The benefit -risk relationship of mRNA -1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-423702 (Patient Link).; Sender's Comments: This Spontaneous case concerns a 49-year-old, male patient, with medical history of pericarditis, who experienced the unexpected, serious (medically significant) events of impaired quality of life, cardiac murmur, gastrointestinal inflammation, neurological symptom, visual impairment, pleurisy, pneumonitis and AESI supraventricular tachycardia. The patient had many adverse events that destroy his quality of life as he couldn't get out of bed for 4 days after receiving the second dose of mRNA-1273 vaccine. He reported a massive inflation of the body in the fourth day and also developed supraventricular tachycardia that required cardioversion to get back to rhythm. Evolved with a heart murmur, severe abdominal  gastrointestinal inflammation and  also   neurological issues that were not specified along with myalgia, feeling of burning,  visual impairment, persistent  headache, persistent lung pleurisy, inflation of the lung, exhaustion and malaise. The rechallenge was not applicable, as no additional dose information was disclosed. The medical history of pericarditis remains as a confounder. The benefit -risk relationship of mRNA -1273 Vaccine is not affected by this report.