Age: 77.0
Sex: M
Vaccine: UNK
Symptoms: Anticoagulant therapy, Drug interaction, Drug-induced liver injury, Pyrexia
Clinical narrative: Possible (drug-vaccine interaction) moderna COVID-19 vaccine mediated enoxaparin-induced liver injury; Possible (drug-vaccine interaction) moderna COVID-19 vaccine mediated enoxapaarin-induced liver injury; low grade fever; This literature-non-study case was reported in a literature article and describes the occurrence of DRUG-INDUCED LIVER INJURY (Possible (drug-vaccine interaction) moderna COVID-19 vaccine mediated enoxaparin-induced liver injury) in a 77-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE:   Co-suspect product included non-company product ENOXAPARIN for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and ENOXAPARIN (unknown route) at an unspecified dose. On an unknown date, the patient experienced DRUG-INDUCED LIVER INJURY (Possible (drug-vaccine interaction) moderna COVID-19 vaccine mediated enoxaparin-induced liver injury) (seriousness criterion medically significant), DRUG INTERACTION (Possible (drug-vaccine interaction) moderna COVID-19 vaccine mediated enoxapaarin-induced liver injury) and PYREXIA (low grade fever). At the time of the report, DRUG-INDUCED LIVER INJURY (Possible (drug-vaccine interaction) moderna COVID-19 vaccine mediated enoxaparin-induced liver injury), DRUG INTERACTION (Possible (drug-vaccine interaction) moderna COVID-19 vaccine mediated enoxapaarin-induced liver injury) and PYREXIA (low grade fever) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered DRUG-INDUCED LIVER INJURY (Possible (drug-vaccine interaction) moderna COVID-19 vaccine mediated enoxaparin-induced liver injury), DRUG INTERACTION (Possible (drug-vaccine interaction) moderna COVID-19 vaccine mediated enoxapaarin-induced liver injury) and PYREXIA (low grade fever) to be related.    No concomitant and treatment medications were reported. Company comment This literature-non-study case concerns a 77-year-old male patient, with medical history of use of ENOXAPARIN as concomitant medication, who experienced the unexpected serious (medically significant) event of DRUG-INDUCED LIVER INJURY, which occurred on an unknown date after receiving the second dose of mRNA-1273 vaccine. Latency cannot be properly assessed. Patient experienced low-grade fever and a possible drug-vaccine interaction between Moderna COVID-19 vaccine and enoxaparin, which induced liver injury. ENOXAPARIN was considered as a co-suspect drug. Until this date no further information was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This literature-non-study case concerns a 77-year-old male patient, with medical history of use of ENOXAPARIN as concomitant medication, who experienced the unexpected serious (medically significant) event of DRUG-INDUCED LIVER INJURY, which occurred on an unknown date after receiving the second dose of mRNA-1273 vaccine. Latency cannot be properly assessed. Patient experienced low-grade fever and a possible drug-vaccine interaction between Moderna COVID-19 vaccine and enoxaparin, which induced liver injury. ENOXAPARIN was considered as a co-suspect drug. Until this date no further information was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.