Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cataract, Fatigue, Hysterotomy, Influenza like illness
Clinical narrative: Plaque psoriasis flare up; Itchy scalp flare up; Right ankle swelling flare up; Joints aches/pain flare up; Cataracts; Flu like symptoms; Achiness; Fatigue; Hysterotomy; This spontaneous case was reported by a consumer and describes the occurrence of CATARACT (Cataracts) in a 67-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) injection for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   In July 2018, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In December 2019, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In 2020, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 17-Oct-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. In May 2021, the patient experienced HYSTEROTOMY (Hysterotomy). On an unknown date, the patient experienced PSORIASIS (Plaque psoriasis flare up), PRURITUS (Itchy scalp flare up), JOINT SWELLING (Right ankle swelling flare up), ARTHRALGIA (Joints aches/pain flare up), CATARACT (Cataracts) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Achiness) and FATIGUE (Fatigue). The patient was treated with AMOXICILLIN at an unspecified dose and frequency; ACETAMINOPHEN at an unspecified dose and frequency; AZITHROMYCIN at an unspecified dose and frequency and HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) at an unspecified dose and frequency. At the time of the report, PSORIASIS (Plaque psoriasis flare up), PRURITUS (Itchy scalp flare up), JOINT SWELLING (Right ankle swelling flare up) and ARTHRALGIA (Joints aches/pain flare up) had not resolved and CATARACT (Cataracts), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Achiness), HYSTEROTOMY (Hysterotomy) and FATIGUE (Fatigue) outcome was unknown.            Concomitant Medication use information was not provided by reporter.  She was off Humira two weeks before and two weeks after the Hysterectomy. After she had her flu shot few weeks ago this Oct 2021, she waited a week before taking her next dose of Humira.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter causality of humira for the event(s) of hysterotomy, achiness, and fatigue was not provided, for the event(s) of cataracts, flu like symptoms and plaque psoriasis flare up with humira  was no reasonable possibility.   The reporter's causality for the event(s) of right ankle swelling flare up, joints aches/pain flare up and itchy scalp flare up with 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.  Company Comment: This is a spontaneous case concerning a 67-year-old female with medical history of psoriatic arthritis, who experienced the unexpected, serious (medically significant) event of Cataract, after receiving the second dose of mRNA-1273 vaccine. Exact onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Medical history of psoriatic arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-623435 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jan-2022: Follow up received that contains Non Significant information.; Sender's Comments: This is a spontaneous case concerning a 67-year-old female with medical history of psoriatic arthritis, who experienced the unexpected, serious (medically significant) event of Cataract, after receiving the second dose of mRNA-1273 vaccine. Exact onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Medical history of psoriatic arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.