Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pain in extremity, Pneumonia, Sinusitis, Ultrasound abdomen
Clinical narrative: lesions on her liver; pneumonia in her right lung; sinusitis; whole right side feels like there is something neurological; burning in right side of her right foot; sharp pain across her abdomen moving from one organ to the other; shooting pains in her right leg; she was sick; shooting pains into her brain; This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC LESION (lesions on her liver) and PNEUMONIA (pneumonia in her right lung) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A and 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Haemophilia (after a routine tonsillectomy that patient was a hemophiliac as a child, but blood clotting became normal as patient got older), Gallstones (20 years ago) and Anaphylaxis (tuberculosis vaccine, iodine contrast, and other medications). Concomitant products included EPINEPHRINE (EPIPEN) for Anaphylaxis.   On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEPATIC LESION (lesions on her liver) (seriousness criterion medically significant), PNEUMONIA (pneumonia in her right lung) (seriousness criterion medically significant), SINUSITIS (sinusitis), FEELING ABNORMAL (whole right side feels like there is something neurological), BURNING SENSATION (burning in right side of her right foot), ABDOMINAL PAIN (sharp pain across her abdomen moving from one organ to the other), PAIN IN EXTREMITY (shooting pains in her right leg), ILLNESS (she was sick) and HEADACHE (shooting pains into her brain). At the time of the report, HEPATIC LESION (lesions on her liver), PNEUMONIA (pneumonia in her right lung), SINUSITIS (sinusitis), FEELING ABNORMAL (whole right side feels like there is something neurological), BURNING SENSATION (burning in right side of her right foot), ABDOMINAL PAIN (sharp pain across her abdomen moving from one organ to the other), PAIN IN EXTREMITY (shooting pains in her right leg), ILLNESS (she was sick) and HEADACHE (shooting pains into her brain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Ultrasound abdomen: lesions on liver (abnormal) lesions on liver.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Lab tests included computerized tomography, magnetic resonance imaging for abdomen with unknown result.  Treatment for the events included strong dose of antibiotics.  Company Comment: This case concerns a 67-year-old, female patient with a medical history of Haemophilia, who experienced the unexpected serious events of Hepatic lesion and pneumonia. The events occurred approximately at an unknown time after the second dose of Spikevax. The rechallenge was not applicable as the events happened after the second dose and there is no information on further doses. The medical history of Haemophilia (although it is mentioned that blood clotting became normal as patient got older), remain a confounder for Hepatic lesion. The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-297358 (Patient Link).; Sender's Comments: This case concerns a 67-year-old, female patient with a medical history of Haemophilia, who experienced the unexpected serious events of Hepatic lesion and pneumonia. The events occurred approximately at an unknown time after the second dose of Spikevax. The rechallenge was not applicable as the events happened after the second dose and there is no information on further doses. The medical history of Haemophilia (although it is mentioned that blood clotting became normal as patient got older), remain a confounder for Hepatic lesion. The benefit-risk relationship of Spikevax is not affected by this report.