Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Sluggishness
Clinical narrative: Cataract; BACK PROBLEMS; COULD NOT RECALL EASILY; SLUGGISH; SLEEP PROBLEMS; HIDRADENITIS SUPPURATIVA OUTBREAK ON FEET; SIDE EFFECTS FROM MODERNA; This spontaneous case was reported by a consumer and describes the occurrence of CATARACT (Cataract) in a 58-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) for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate free. On an unknown date, the patient experienced CATARACT (Cataract) (seriousness criterion medically significant), MUSCULOSKELETAL DISCOMFORT (BACK PROBLEMS), MEMORY IMPAIRMENT (COULD NOT RECALL EASILY), SLUGGISHNESS (SLUGGISH), SLEEP DISORDER (SLEEP PROBLEMS), HIDRADENITIS (HIDRADENITIS SUPPURATIVA OUTBREAK ON FEET) and IMMUNISATION REACTION (SIDE EFFECTS FROM MODERNA). At the time of the report, CATARACT (Cataract), MUSCULOSKELETAL DISCOMFORT (BACK PROBLEMS), MEMORY IMPAIRMENT (COULD NOT RECALL EASILY), SLUGGISHNESS (SLUGGISH), SLEEP DISORDER (SLEEP PROBLEMS), HIDRADENITIS (HIDRADENITIS SUPPURATIVA OUTBREAK ON FEET) and IMMUNISATION REACTION (SIDE EFFECTS FROM MODERNA) outcome was unknown.            No concomitant medications provided by reporter. No treatment medications provided by reporter.  The symptoms Furuncle, Rash and pain subsumed under Hidradenitis  It was reported that patient had cataract surgery. Reporters causality for event Skin break out and pain was probable and for all other events was not reported with respect to Humira drug.  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 commentr-This spontaneous case concerns a female patient aged 58 years with no relevant medical history reported, who experienced the unexpected serious (medically significant) event of Cataract on unknown date in the context of mRNA-1273 vaccination. Patient had received 1st and booster doses of same vaccine on unknown dates. Latency cannot be assessed since vaccination date nor event onset date were provided. She had cataract surgery and could not recall easily. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the event was not known at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a female patient aged 58 years with no relevant medical history reported, who experienced the unexpected serious (medically significant) event of Cataract on unknown date in the context of mRNA-1273 vaccination. Patient had received 1st and booster doses of same vaccine on unknown dates. Latency cannot be assessed since vaccination date nor event onset date were provided. She had cataract surgery and could not recall easily. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the event was not known at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.