Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pericarditis
Clinical narrative: pericarditis; My husband was in a lot of pain; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDITIS (pericarditis) in a 70-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Dialysis.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced PERICARDITIS (pericarditis) (seriousness criterion medically significant) and PAIN (My husband was in a lot of pain). At the time of the report, PERICARDITIS (pericarditis) and PAIN (My husband was in a lot of pain) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported. No treatment information was provided.  Wife called to report that her 70-year-old husband received a bivalent booster on unknown date (About 3 months ago) and 2-3 weeks later had pericarditis and ended up in the hospital. Caller does not have the vaccination card and her husband is gone to dialysis right now. He has been on dialysis for 3 years. Wife states that he had a healthy heart prior to vaccination. Agent tried to get more information, but wife states to follow up via mail for more information from her husband. She states her husband was in a lot of pain and he could have died..  Company comment: This spontaneous case concerns a 70 year old male patient with no cardiovascular pathology identified, and no known prior COVID 19 infection, who experienced the expected, serious (medically significant) AESI of Pericarditis , about 2 to 3 weeks after receiving a dose (additional booster) with mRNA-1273.222 bivalent vaccine. The patient experienced pain along with the event and ended up in the hospital. No information on risk factors, detailed clinical course, investigations, treatment of the event, outcome and details pertaining to the previous doses was available in the report. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report.    This case was linked to US-MODERNATX, INC.-MOD-2022-689723.; Sender's Comments: This spontaneous case concerns a 70 year old male patient with no cardiovascular pathology identified, and no known prior COVID 19 infection, who experienced the expected, serious (medically significant) AESI of Pericarditis , about 2 to 3 weeks after receiving a dose (additional booster) with mRNA-1273.222 bivalent vaccine. The patient experienced pain along with the event and ended up in the hospital. No information on risk factors, detailed clinical course, investigations, treatment of the event, outcome and details pertaining to the previous doses was available in the report. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-689723:Wife's case