Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Hepatomegaly, Inflammation, Splenomegaly
Clinical narrative: Pain increase to her upper abdomen; Spleen slightly enlarge; Liver was slightly enlarge; Excruciating back pain; Severe inflammatory reaction; Back pain felt like drop from a two-story house into a pavement; This spontaneous case was reported by a consumer and describes the occurrence of SPLENOMEGALY (Spleen slightly enlarge), HEPATOMEGALY (Liver was slightly enlarge), BACK PAIN (Excruciating back pain) and ABDOMINAL PAIN UPPER (Pain increase to her upper abdomen) in a 22-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.     No medical history information was reported.  Concurrent medical conditions included Analgesic effect (Patient has been taking PARACETAMOL and IBUPROFEN.).   On 08-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2021, the patient experienced BACK PAIN (Excruciating back pain) (seriousness criterion hospitalization). On 14-Jul-2021, the patient experienced SPLENOMEGALY (Spleen slightly enlarge) (seriousness criterion hospitalization) and HEPATOMEGALY (Liver was slightly enlarge) (seriousness criterion hospitalization). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Pain increase to her upper abdomen) (seriousness criterion hospitalization), INFLAMMATION (Severe inflammatory reaction) and BACK PAIN (Back pain felt like drop from a two-story house into a pavement). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, SPLENOMEGALY (Spleen slightly enlarge), HEPATOMEGALY (Liver was slightly enlarge), BACK PAIN (Excruciating back pain), ABDOMINAL PAIN UPPER (Pain increase to her upper abdomen), INFLAMMATION (Severe inflammatory reaction) and BACK PAIN (Back pain felt like drop from a two-story house into a pavement) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was hospitalized for 3 days.  Onan unknown date, CT scan showed that spleen and liver was slightly enlarge.  Her inflammatory marker was 72.9, the normal range below 9.  Concomitant products was not provided. The patient was taking other medication (unspecified).  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. However, the medical history/ occurrence of PARACETAMOL and IBUPROFEN could be a contributory factor.; 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. However, the medical history/ occurrence of PARACETAMOL and IBUPROFEN could be a contributory factor.