Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Injury, Joint stiffness, Mental fatigue, Nervous system disorder
Clinical narrative: Cataracts in right eye; Internal hemorrhoids; Sarcoidosis with octal involvement of right eye; Uveitis flare up/right eye was slightly worsened/pressure and swelling in right eye; Pre glaucoma; Sarcoidosis with octal involvement of right eye; Photophobia; Nerve disorder; Hot flashes; Occasional soreness and achiness; high blood pressure; Anxiety; Vision a little worse; Flare up/stiffness in joints; Mentaly fatigued; Bruised on knees from falling; Stressed; Bruised on knees from falling; lowIron; Flare up/back and hip pain; Injury; Sinus infection; sweats; Sore arm/tender arm from moderna vaccinations; Flare up/back and hip pain; Fatigued from moderna vaccinations; Dose 1 administered on 19-Apr-2021 and then Dose 2 administered on 26-May-2021; This spontaneous case was reported by a consumer and describes the occurrence of CATARACT (Cataracts in right eye), HAEMORRHOIDS (Internal hemorrhoids), SARCOIDOSIS (Sarcoidosis with octal involvement of right eye), UVEITIS (Uveitis flare up/right eye was slightly worsened/pressure and swelling in right eye), GLAUCOMA (Pre glaucoma) and OCULAR SARCOIDOSIS (Sarcoidosis with octal involvement of right eye) in a 51-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Uveitis.    The patient's past medical history included Sweating, Blurred vision, Eye floaters, Eye pain, Eye redness and Photophobia. Concurrent medical conditions included Uveitis.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. On 01-Aug-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. On 26-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 19-Apr-2021 and then Dose 2 administered on 26-May-2021). On an unknown date, the patient experienced CATARACT (Cataracts in right eye) (seriousness criterion medically significant), HAEMORRHOIDS (Internal hemorrhoids) (seriousness criterion medically significant), SARCOIDOSIS (Sarcoidosis with octal involvement of right eye) (seriousness criterion medically significant), UVEITIS (Uveitis flare up/right eye was slightly worsened/pressure and swelling in right eye) (seriousness criterion medically significant), GLAUCOMA (Pre glaucoma) (seriousness criterion medically significant), OCULAR SARCOIDOSIS (Sarcoidosis with octal involvement of right eye) (seriousness criterion medically significant), PHOTOPHOBIA (Photophobia), NERVOUS SYSTEM DISORDER (Nerve disorder), HOT FLUSH (Hot flashes), PAIN (Occasional soreness and achiness), HYPERTENSION (high blood pressure), ANXIETY (Anxiety), VISUAL IMPAIRMENT (Vision a little worse), JOINT STIFFNESS (Flare up/stiffness in joints), MENTAL FATIGUE (Mentaly fatigued), CONTUSION (Bruised on knees from falling), STRESS (Stressed), FALL (Bruised on knees from falling), BLOOD IRON DECREASED (lowIron), BACK PAIN (Flare up/back and hip pain), INJURY (Injury), SINUSITIS (Sinus infection), HYPERHIDROSIS (sweats), VACCINATION SITE PAIN (Sore arm/tender arm from moderna vaccinations), ARTHRALGIA (Flare up/back and hip pain) and FATIGUE (Fatigued from moderna vaccinations). At the time of the report, CATARACT (Cataracts in right eye), HAEMORRHOIDS (Internal hemorrhoids), SARCOIDOSIS (Sarcoidosis with octal involvement of right eye), UVEITIS (Uveitis flare up/right eye was slightly worsened/pressure and swelling in right eye), GLAUCOMA (Pre glaucoma), PHOTOPHOBIA (Photophobia), NERVOUS SYSTEM DISORDER (Nerve disorder), HOT FLUSH (Hot flashes), PAIN (Occasional soreness and achiness), HYPERTENSION (high blood pressure), ANXIETY (Anxiety) and VISUAL IMPAIRMENT (Vision a little worse) had not resolved, OCULAR SARCOIDOSIS (Sarcoidosis with octal involvement of right eye), JOINT STIFFNESS (Flare up/stiffness in joints), MENTAL FATIGUE (Mentaly fatigued), CONTUSION (Bruised on knees from falling), STRESS (Stressed), FALL (Bruised on knees from falling), BLOOD IRON DECREASED (lowIron), BACK PAIN (Flare up/back and hip pain), INJURY (Injury), SINUSITIS (Sinus infection), VACCINATION SITE PAIN (Sore arm/tender arm from moderna vaccinations), ARTHRALGIA (Flare up/back and hip pain), FATIGUE (Fatigued from moderna vaccinations) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 19-Apr-2021 and then Dose 2 administered on 26-May-2021) outcome was unknown and HYPERHIDROSIS (sweats) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood iron: Low. On an unknown date, Blood pressure measurement: High. On an unknown date, Ophthalmological examination: Right eye vision was 20/70.         Suspect Moderna Covid-19 vaccine reported as Unknown.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Concomitant medication was not provided.  She had internal Hemorrhoids removed and anxiety, bruised on knees from falling and fall caused mild flare up of pain threw body. She had Sarcoidosis with octal involvement of right eye and had sinus infection with difficulty breathing.  The reporter's causality for the events of pre glaucoma and uveitis flare up/right eye was slightly worsened/pressure and swelling in right eye with adalimumab solution for injection was reasonable possibility. The reporter's causality for the events of anxiety, bruised on knees from falling, cataracts in right eye, fatigued from moderna vaccinations/fatigue in joints, flare up/back and hip pain unknown onset, flare up/stiffness in joints, high blood pressure, internal hemorrhoids, mentally fatigued, nerve disorder, occasional soreness and achiness, sarcoidosis with octal involvement of right eye, sore arm/tender arm from moderna vaccinations, stressed, hot flashes, injury with adalimumab solution for injection was no reasonable possibility.  Treatment medication information was not provided by the reporter.  Company comment: This spontaneous case concerns a 51-year-old female patient, in treatment with adalimumab due to uveitis, who received three doses of mRNA - 1273 original vaccine and experienced the unexpected, serious (medially significant) events of cataract, sarcoidosis, ocular sarcoidosis, uveitis, glaucoma, and haemorrhoids. Latency cannot be properly assessed since exact onset date was not provided. Inappropriate schedule of product administration (35 - days interval) was noted in the primary schedule. The report stated that the patient experienced a flare up of with back and hip pain, burry vision, fatigue, stiffness, and soreness in joints. Her right eye was slightly worsened (right eye vision was 20/70). She had "Pre-Glaucoma", cataracts in right eye, and sarcoidosis with involvement of right eye. On an unspecified date she had internal hemorrhoids removed. The outcome of cataract, sarcoidosis, uveitis, glaucoma, and hemorrhoids was not recovered. No further clinical details were provided for medical reviewing. Sarcoidosis represents a risk factor for ocular sarcoidosis and uveitis. Cataract formation and glaucoma could be complications of uveitis. Uveitis can flare as part of its natural history. Patient´s age could be confounder factor for haemorrhoids. Co-suspect product included non-company product adalimumab. The benefit-risk relationship of mRNA - 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 51-year-old female patient, in treatment with adalimumab due to uveitis, who received three doses of mRNA - 1273 original vaccine and experienced the unexpected, serious (medially significant) events of cataract, sarcoidosis, ocular sarcoidosis, uveitis, glaucoma, and haemorrhoids. Latency cannot be properly assessed since exact onset date was not provided. Inappropriate schedule of product administration (35 - days interval) was noted in the primary schedule. The report stated that the patient experienced a flare up of with back and hip pain, burry vision, fatigue, stiffness, and soreness in joints. Her right eye was slightly worsened (right eye vision was 20/70). She had "Pre-Glaucoma", cataracts in right eye, and sarcoidosis with involvement of right eye. On an unspecified date she had internal hemorrhoids removed. The outcome of cataract, sarcoidosis, uveitis, glaucoma, and hemorrhoids was not recovered. No further clinical details were provided for medical reviewing. Sarcoidosis represents a risk factor for ocular sarcoidosis and uveitis. Cataract formation and glaucoma could be complications of uveitis. Uveitis can flare as part of its natural history. Patient´s age could be confounder factor for haemorrhoids. Co-suspect product included non-company product adalimumab. The benefit-risk relationship of mRNA - 1273 vaccine is not affected by this report.