Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Hepatitis, Nausea, Pain
Clinical narrative: They also said I had some inflammation of the liver.; I had a huge amount of swelling underneath & above both my eyelids.; right back pain that went into the right shoulder blade.; I had vomiting; I had nausea; The pain radiated around my side to my back.; I started feeling a dull pain on my right side, above rib cage.; This spontaneous case was reported by a consumer and describes the occurrence of HEPATITIS (They also said I had some inflammation of the liver.), SWELLING OF EYELID (I had a huge amount of swelling underneath & above both my eyelids.), BACK PAIN (The pain radiated around my side to my back.), PAIN (I started feeling a dull pain on my right side, above rib cage.), ARTHRALGIA (right back pain that went into the right shoulder blade.), VOMITING (I had vomiting) and NAUSEA (I had nausea) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     The patient's past medical history included Gilbert's syndrome (blood disorder) and Kidney stones.    On 02-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced BACK PAIN (The pain radiated around my side to my back.) (seriousness criterion medically significant) and PAIN (I started feeling a dull pain on my right side, above rib cage.) (seriousness criterion medically significant). On 03-Sep-2021, the patient experienced HEPATITIS (They also said I had some inflammation of the liver.) (seriousness criterion medically significant), SWELLING OF EYELID (I had a huge amount of swelling underneath & above both my eyelids.) (seriousness criterion medically significant), ARTHRALGIA (right back pain that went into the right shoulder blade.) (seriousness criterion medically significant), VOMITING (I had vomiting) (seriousness criterion medically significant) and NAUSEA (I had nausea) (seriousness criterion medically significant). At the time of the report, HEPATITIS (They also said I had some inflammation of the liver.), SWELLING OF EYELID (I had a huge amount of swelling underneath & above both my eyelids.), BACK PAIN (The pain radiated around my side to my back.), PAIN (I started feeling a dull pain on my right side, above rib cage.), ARTHRALGIA (right back pain that went into the right shoulder blade.), VOMITING (I had vomiting) and NAUSEA (I had nausea) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Concomitant medication information not provided.  Treatment information not provided.  Patient was not been to work in a year, due to car wreck.   patient was to advised not to take another dose of the vaccine.  Company Comment: The report concerns a 53 year old female patient with medical history of gilbert's syndrome and kidney stones who experienced serious unexpected events of radiating back pain, dull aching pain, swelling of the eyelid, arthralgia, hepatitis, vomiting and nausea after vaccination with first dose of mRNA-1273 on the same day. It was reported that the  patient was advised not to take the second dose of the vaccine. The medical history of gilbert's syndrome remains a confounder for the reported events. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: The report concerns a 53 year old female patient with medical history of gilbert's syndrome and kidney stones who experienced serious unexpected events of radiating back pain, dull aching pain, swelling of the eyelid, arthralgia, hepatitis, vomiting and nausea after vaccination with first dose of mRNA-1273 on the same day. It was reported that the  patient was advised not to take the second dose of the vaccine. The medical history of gilbert's syndrome remains a confounder for the reported events. The benefit-risk relationship of mRNA-1273 is not affected by this report.