Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Aqueous humour leakage, Arthralgia, Back pain, Dyspnoea, Eye oedema
Clinical narrative: her right hip was hurting again; Osteoarthritis; Infected insect bite; Back muscle spasms; Back pain; Pain in arm; Vaccination site pain; FLUID IN LEFT EYE; Eye edema; Ulna fracture; Breathing difficult; This spontaneous case was reported by a consumer and describes the occurrence of AQUEOUS HUMOUR LEAKAGE (FLUID IN LEFT EYE) in a 63-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 Rheumatoid arthritis.    The patient's past medical history included Rheumatoid arthritis.   In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Aug-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Sep-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 received first dose of ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, received second dose of ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 1 dosage form, second dose of ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 1 dosage form and fourth dose of ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 1 dosage form. In 2021, the patient experienced AQUEOUS HUMOUR LEAKAGE (FLUID IN LEFT EYE) (seriousness criterion medically significant), EYE OEDEMA (Eye edema), ULNA FRACTURE (Ulna fracture) and DYSPNOEA (Breathing difficult). In September 2021, the patient experienced OSTEOARTHRITIS (Osteoarthritis), INFECTED BITE (Infected insect bite), MUSCLE SPASMS (Back muscle spasms), BACK PAIN (Back pain), PAIN IN EXTREMITY (Pain in arm) and VACCINATION SITE PAIN (Vaccination site pain). On an unknown date, the patient experienced ARTHRALGIA (her right hip was hurting again). At the time of the report, AQUEOUS HUMOUR LEAKAGE (FLUID IN LEFT EYE), EYE OEDEMA (Eye edema), PAIN IN EXTREMITY (Pain in arm) and ARTHRALGIA (her right hip was hurting again) outcome was unknown, OSTEOARTHRITIS (Osteoarthritis), MUSCLE SPASMS (Back muscle spasms) and DYSPNOEA (Breathing difficult) was resolving, INFECTED BITE (Infected insect bite) and VACCINATION SITE PAIN (Vaccination site pain) had resolved and BACK PAIN (Back pain) and ULNA FRACTURE (Ulna fracture) had not resolved.            No Concomitant medications were reported No treatment medications were reported. Patient had PLATELET RICH PLASMA SURGERY on back and it was in recovering mode. 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 spontaneous case concerns a 63-year-old female patient with no relevant medical history reported, who experienced the unexpected, serious event of aqueous humour leakage an unknown time after the first and second dose of mRNA-1273. Concomitant event of eye oedema could be a risk factor for the event. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Live significant follow-up appended - Event and Dose information added. On 17-Dec-2021: Live significant follow-up appended. New events were added.; Sender's Comments: This spontaneous case concerns a 63-year-old female patient with no relevant medical history reported, who experienced the unexpected, serious event of aqueous humour leakage an unknown time after the first and second dose of mRNA-1273. Concomitant event of eye oedema could be a risk factor for the event. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.