Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Eye infection syphilitic, Hepatic enzyme increased, Incorrect dose administered, Macular oedema, Magnetic resonance imaging
Clinical narrative: PANUVEITIS BOTH EYES; VITRITIS LEFT EYE; DISSEMINATED RETINITIS AND RETINOCHOROIDITIS; CHOROIDAL NEOVASCULARIZATION LEFT EYE; POSTERIOR VITREOUS DETACHMENT; Choroiditis; INTRARETINAL FLUID INCREASED; DISSEMINATED RETINITIS AND RETINOCHOROIDITIS; LOSING WEIGHT; EPIRETINAL MEMBRANE BOTH EYES; NUCLEAR SCLEROSIS RIGHT EYE; OCULAR HYPERTENSION LEFT EYE; MACULAR EDEMA BOTH EYES; OPTIC ATROPHY IN LEFT EYE; PANUVEITIS BOTH EYES; Patient took two doses of Moderna, an unknown dose and a booster.; LIVER ENZYMES ELEVATED; OPTIC DISC HAEMORRHAGE UNSPECIFIED IN LEFT EYE/OPTIC DISC HAEMORRHAGE; This spontaneous case was reported by a consumer and describes the occurrence of CATARACT NUCLEAR (NUCLEAR SCLEROSIS RIGHT EYE), OCULAR HYPERTENSION (OCULAR HYPERTENSION LEFT EYE), MACULAR OEDEMA (MACULAR EDEMA BOTH EYES), OPTIC ATROPHY (OPTIC ATROPHY IN LEFT EYE), OPTIC DISC HAEMORRHAGE (OPTIC DISC HAEMORRHAGE UNSPECIFIED IN LEFT EYE/OPTIC DISC HAEMORRHAGE), UVEITIS (PANUVEITIS BOTH EYES), VITRITIS (VITRITIS LEFT EYE), RETINITIS (DISSEMINATED RETINITIS AND RETINOCHOROIDITIS), CHOROIDAL NEOVASCULARISATION (CHOROIDAL NEOVASCULARIZATION LEFT EYE), VITREOUS DETACHMENT (POSTERIOR VITREOUS DETACHMENT), CHOROIDITIS (Choroiditis), RETINAL OEDEMA (INTRARETINAL FLUID INCREASED) and EYE INFECTION SYPHILITIC (DISSEMINATED RETINITIS AND RETINOCHOROIDITIS) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Panuveitis.    The patient's past medical history included Brain biopsy in 2000, Oligodendroglioma (RIGHT FRONTAL OLIGODENDROGLIOMA GRADE 2) on 06-Feb-2000, Testicle absent (LESION ON TESTICLE) on 21-Jul-2014, Intraocular pressure (INCREASED INTRAOCULAR PRESSURE IN SUNTENON STEROID) on 05-Jan-2015, Glaucoma steroid-induced (STEROID INDUCED GLAUCOMA,RESIDUAL STAGE,SUBSEQUENT ENCOUNTER) on 05-Jan-2015, Epiretinal membrane peel (EPIRETINAL MEMBRANE REMOVAL LEFT EYE) on 06-Aug-2015 and Posterior vitreous detachment (POSTERIOR VITREOUS DETACHMENT BOTH EYES) on 18-Oct-2016. Previously administered products included for Drug use for unknown indication: AZITHROMYCIN and DEMEROL. Past adverse reactions to the above products included No adverse event with AZITHROMYCIN and DEMEROL. Concurrent medical conditions included Seizures since 2000, Pneumonia since 20-Oct-2014, Hypercholesterolemia, Hypertension (SYSTEMIC HYPERTENSION), Drug allergy (DEMEROL ALLERGY), Allergy to antibiotic (AZITHROMYCIN ALLERGY), Non-tobacco user, Panuveitis and Brain neoplasm malignant. Concomitant products included PREDNISOLONE ACETATE, DORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE (DORZOLAMIDE + TIMOLOL), FOLIC ACID, NEPAFENAC (ILEVRO), VITAMIN D3, BRIMONIDINE, EZETIMIBE (ZETIA), CARBAMAZEPINE, ATORVASTATIN, HYDROCHLOROTHIAZIDE, LISINOPRIL and METHOTREXATE for an unknown indication.   On 19-Jan-2018, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to (1 in 2 wk), 40 Milligram. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On 16-Sep-2021, the patient experienced OPTIC DISC HAEMORRHAGE (OPTIC DISC HAEMORRHAGE UNSPECIFIED IN LEFT EYE/OPTIC DISC HAEMORRHAGE) (seriousness criterion medically significant). In December 2021, the patient experienced HEPATIC ENZYME INCREASED (LIVER ENZYMES ELEVATED). On an unknown date, the patient experienced CATARACT NUCLEAR (NUCLEAR SCLEROSIS RIGHT EYE) (seriousness criterion medically significant), OCULAR HYPERTENSION (OCULAR HYPERTENSION LEFT EYE) (seriousness criterion medically significant), MACULAR OEDEMA (MACULAR EDEMA BOTH EYES) (seriousness criterion medically significant), OPTIC ATROPHY (OPTIC ATROPHY IN LEFT EYE) (seriousness criterion medically significant), UVEITIS (PANUVEITIS BOTH EYES) (seriousness criterion medically significant), VITRITIS (VITRITIS LEFT EYE) (seriousness criterion medically significant), RETINITIS (DISSEMINATED RETINITIS AND RETINOCHOROIDITIS) (seriousness criterion medically significant), CHOROIDAL NEOVASCULARISATION (CHOROIDAL NEOVASCULARIZATION LEFT EYE) (seriousness criterion medically significant), VITREOUS DETACHMENT (POSTERIOR VITREOUS DETACHMENT) (seriousness criterion medically significant), CHOROIDITIS (Choroiditis) (seriousness criterion medically significant), RETINAL OEDEMA (INTRARETINAL FLUID INCREASED) (seriousness criterion medically significant), EYE INFECTION SYPHILITIC (DISSEMINATED RETINITIS AND RETINOCHOROIDITIS) (seriousness criterion medically significant), WEIGHT DECREASED (LOSING WEIGHT), EPIRETINAL MEMBRANE (EPIRETINAL MEMBRANE BOTH EYES), CONDITION AGGRAVATED (PANUVEITIS BOTH EYES) and INCORRECT DOSE ADMINISTERED (Patient took two doses of Moderna, an unknown dose and a booster.). At the time of the report, CATARACT NUCLEAR (NUCLEAR SCLEROSIS RIGHT EYE), OCULAR HYPERTENSION (OCULAR HYPERTENSION LEFT EYE), MACULAR OEDEMA (MACULAR EDEMA BOTH EYES), OPTIC ATROPHY (OPTIC ATROPHY IN LEFT EYE), OPTIC DISC HAEMORRHAGE (OPTIC DISC HAEMORRHAGE UNSPECIFIED IN LEFT EYE/OPTIC DISC HAEMORRHAGE), UVEITIS (PANUVEITIS BOTH EYES), VITRITIS (VITRITIS LEFT EYE), RETINITIS (DISSEMINATED RETINITIS AND RETINOCHOROIDITIS), CHOROIDAL NEOVASCULARISATION (CHOROIDAL NEOVASCULARIZATION LEFT EYE), VITREOUS DETACHMENT (POSTERIOR VITREOUS DETACHMENT), CHOROIDITIS (Choroiditis), RETINAL OEDEMA (INTRARETINAL FLUID INCREASED), EYE INFECTION SYPHILITIC (DISSEMINATED RETINITIS AND RETINOCHOROIDITIS), WEIGHT DECREASED (LOSING WEIGHT), EPIRETINAL MEMBRANE (EPIRETINAL MEMBRANE BOTH EYES), HEPATIC ENZYME INCREASED (LIVER ENZYMES ELEVATED), CONDITION AGGRAVATED (PANUVEITIS BOTH EYES) and INCORRECT DOSE ADMINISTERED (Patient took two doses of Moderna, an unknown dose and a booster.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2014, Magnetic resonance imaging: change in orbit and optics. In June 2020, Magnetic resonance imaging: no changes were observed. In December 2021, Hepatic enzyme increased: Mild/Moderate. On an unknown date, Magnetic resonance imaging: found out brain Cancer. and No multiple Sclerosis. On an unknown date, Weight: Decreased.         Patients relevant history included non alcoholic user and it was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporters causality for the events of nuclear sclerosis right eye, ocular hypertension left eye, macular edema both eyes, optic disc hemorrhage, optic atrophy in left eye, optic disc hemorrhage unspecified in left eye, accidentally gave double dose of covid booster, losing weight, panuveitis both eyes, vitritis left eye, disseminated retinitis and retinochoroiditis unknown onset, choroidal neovascularization left eye, epiretinal membrane both eyes, posterior vitreous detachment, disseminated retinitis and retinochoroiditis unknown onset, epiretinal membrane in both eyes, intraretinal fluid increased and liver enzymes elevated was not provided. The reporter's causality for the events of brain cancer/brain tumour with Humira 40mg/0.8ml(adalimumab) was no reasonable possibility.  Treatment medication included pills(unspecified).  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a spontaneous case concerning a 69-year-old male patient with medical history of Brain cancer and Panuveitis, who experienced the unexpected, serious (medically significant) events of Cataract nuclear, Ocular hypertension, Macular oedema, Optic atrophy, Optic disc haemorrhage, Uveitis, Vitritis, Retinitis, Choroidal neovascularization, Vitreous detachment, Choroiditis, Retinal oedema and Eye infection syphilitic, after receiving the booster dose of mRNA-1273 vaccine. Exact date of vaccination and onset date of the events, relevant diagnostic tests and further treatment details were not provided in the case. The outcome of the events were unknown at the time of the report.  Medical history of Brain cancer and Panuveitis remain as risk factors for the events. Incorrect dose administered was also reported as the patient received double dose of the booster dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.  Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2022: Follow up received contains updated suspect vaccine dose details of Moderna and suspect drug Humira, event updated and treatment mentioned. On 31-Mar-2022: Follow up received contains significant information, relevant history, lab data, concomitants, events and updated start date and stop date of suspect drug humira.; Sender's Comments: This is a spontaneous case concerning a 69-year-old male patient with medical history of Brain cancer and Panuveitis, who experienced the unexpected, serious (medically significant) events of Cataract nuclear, Ocular hypertension, Macular oedema, Optic atrophy, Optic disc haemorrhage, Uveitis, Vitritis, Retinitis, Choroidal neovascularization, Vitreous detachment, Choroiditis, Retinal oedema and Eye infection syphilitic, after receiving the booster dose of mRNA-1273 vaccine. Exact date of vaccination and onset date of the events, relevant diagnostic tests and further treatment details were not provided in the case. The outcome of the events were unknown at the time of the report.  Medical history of Brain cancer and Panuveitis remain as risk factors for the events. Incorrect dose administered was also reported as the patient received double dose of the booster dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.