Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Cataract, Furuncle, Ophthalmological examination, Pain in extremity
Clinical narrative: After second Moderna COVID-19 vaccination pain in legs, hair breakage/four inches of hair was breaking, hair loss and breakouts under arms and groin area were red and boils; After second Moderna COVID-19 vaccination pain in legs, hair breakage/four inches of hair was breaking, hair loss and breakouts under arms and groin area were red and boils; cataract for both eyes/but left eye was completely blocked with cataract and much worse than the right eye; After second Moderna COVID-19 vaccination pain in legs, hair breakage/four inches of hair was breaking, hair loss and breakouts under arms and groin area were red and boils; This spontaneous case was reported by a consumer and describes the occurrence of CATARACT (cataract for both eyes/but left eye was completely blocked with cataract and much worse than the right eye) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M2DA and 027A21A) 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 Hidradenitis suppurativa and Panuveitis.    The patient's past medical history included Panuveitis and Hidradenitis suppurativa. Family history included Huntington's disease (had Huntington's disease which was a genetic condition got from her grandfather and grandmother) since an unknown date. Concurrent medical conditions included Seizure, Non-tobacco user and Abstains from alcohol. Concomitant products included VALPROATE SEMISODIUM (DEPAKOTE) and ZONISAMIDE for Seizure.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second 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 once a week. On 24-May-2021, the patient experienced CATARACT (cataract for both eyes/but left eye was completely blocked with cataract and much worse than the right eye) (seriousness criterion medically significant). In 2021, the patient experienced PAIN IN EXTREMITY (After second Moderna COVID-19 vaccination pain in legs, hair breakage/four inches of hair was breaking, hair loss and breakouts under arms and groin area were red and boils). On an unknown date, the patient experienced ALOPECIA (After second Moderna COVID-19 vaccination pain in legs, hair breakage/four inches of hair was breaking, hair loss and breakouts under arms and groin area were red and boils) and FURUNCLE (After second Moderna COVID-19 vaccination pain in legs, hair breakage/four inches of hair was breaking, hair loss and breakouts under arms and groin area were red and boils). At the time of the report, CATARACT (cataract for both eyes/but left eye was completely blocked with cataract and much worse than the right eye), ALOPECIA (After second Moderna COVID-19 vaccination pain in legs, hair breakage/four inches of hair was breaking, hair loss and breakouts under arms and groin area were red and boils) and FURUNCLE (After second Moderna COVID-19 vaccination pain in legs, hair breakage/four inches of hair was breaking, hair loss and breakouts under arms and groin area were red and boils) had not resolved and PAIN IN EXTREMITY (After second Moderna COVID-19 vaccination pain in legs, hair breakage/four inches of hair was breaking, hair loss and breakouts under arms and groin area were red and boils) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, Ophthalmological examination: Cataract for both eyes.   Company comment : This spontaneous case concerns a female patient aged 45 years with relevant medical history of panuveitis and hidradenitis suppurativa reported, who experienced the unexpected serious (medically significant) event of Cataract aggravated(cataract for both eyes/but left eye was completely blocked with cataract and much worse than the right eye), that occurred  81 days after second dose of mRNA-1273 vaccination. Patient had received initial two doses of mRNA-1273 at an interval of 28 days. No further information on clinical course, lab investigations and treatment received was available in the report. Outcome of the event was not resolved at the time of report. Relevant medical history of panuveitis remains a confounder to the event Cataract aggravated. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.      The co-suspect Humira concentration was reported as 40 MG/ 0.8 ML and formulation was reported as solution for injection in pre-filled pen. The patient had been climbing stairs in her home for 15 years. Patient had hair loss, thinning hair and hair breakage wherein four inches of hair was breaking from bottom up which started a couple of months after starting co-suspect Humira. patient had depth perception wherein patient could not find the stair but upon checking up with the physician, it was found that patient had cataract for both eyes but her left eye was completely blocked with cataract and much worse than the right eye and could not climb stairs as of 26-May-2021. She did not shot and issues with insurance. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was reported.  The reporter causality for the event cataract for both eyes/but left eye was completely blocked with cataract and much worse than the right eye with co-suspect Humira was not provided. The reporter causality for the event after second moderna covid-19 vaccination pain in legs, hair loss and breakouts under arms and groin area were red and boils with co-suspect Humira was no reasonable possibility. The reporter causality for the event hair breakage/four inches of hair was breaking with co-suspect Humira was a reasonable possibility.  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.; Sender's Comments: This spontaneous case concerns a female patient aged 45 years with relevant medical history of panuveitis and hidradenitis suppurativa reported, who experienced the unexpected serious (medically significant) event of Cataract aggravated(cataract for both eyes/but left eye was completely blocked with cataract and much worse than the right eye), that occurred  81 days after second dose of mRNA-1273 vaccination. Patient had received initial two doses of mRNA-1273 at an interval of 28 days. No further information on clinical course, lab investigations and treatment received was available in the report. Outcome of the event was not resolved at the time of report. Relevant medical history of panuveitis remains a confounder to the event Cataract aggravated. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.