Age: 78.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dry eye, Eye disorder, Parkinson's disease, Vaccination site pain, Vaccination site swelling
Clinical narrative: PARKINSONS DISEASE; BLISTER IN EYE; DRY EYE; SWELLED/SORE ARM FROM BOOSTER VACCINE; SWELLED/SORE ARM FROM BOOSTER VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of PARKINSON'S DISEASE (PARKINSONS DISEASE) in a 78-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.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Aug-2021, received third 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 mg/0.4 mL(40 Milligram, Solution for injection in pre-filled pen). On 18-Aug-2021, the patient experienced VACCINATION SITE PAIN (SWELLED/SORE ARM FROM BOOSTER VACCINE) and VACCINATION SITE SWELLING (SWELLED/SORE ARM FROM BOOSTER VACCINE). On an unknown date, the patient experienced PARKINSON'S DISEASE (PARKINSONS DISEASE) (seriousness criterion medically significant), EYE DISORDER (BLISTER IN EYE) and DRY EYE (DRY EYE). At the time of the report, PARKINSON'S DISEASE (PARKINSONS DISEASE), EYE DISORDER (BLISTER IN EYE), DRY EYE (DRY EYE), VACCINATION SITE PAIN (SWELLED/SORE ARM FROM BOOSTER VACCINE) and VACCINATION SITE SWELLING (SWELLED/SORE ARM FROM BOOSTER VACCINE) was resolving.            Concomitant medication was not reported.  The formulation for co-suspect product Humira was reported as Solution for injection in pre-filled pen. On unknown dates, the patient experienced Parkinson's disease, blister in eye and dry eye. On 18-Aug-2021, the patient experienced swelled/sore arm from booster vaccine. Treatment details not reported. The reporter's causality for the event(s) of Parkinson's disease, swelled/sore arm from booster vaccine, blister in eye and dry eye with Humira(adalimumab) was no reasonable possibility.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  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 78-year-old female patient with Rheumatoid arthritis on treatment with Adalimumab, who experienced the serious (medically significant) unexpected event Parkinson´s disease, on an unknown date after the third dose of mRNA-1273. Clinical findings, diagnostic tests and treatment details were not provided. Blister in eye, dry eye and vaccination site pain were also reported as events. At the time of the report, events were resolving. Events seriousness captured as per IME list. Adalimumab was reported as a co-suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Live follow-up attached. Dose information added.; Sender's Comments: Company comment: This is a spontaneous case concerning a 78-year-old female patient with Rheumatoid arthritis on treatment with Adalimumab, who experienced the serious (medically significant) unexpected event Parkinson´s disease, on an unknown date after the third dose of mRNA-1273. Clinical findings, diagnostic tests and treatment details were not provided. Blister in eye, dry eye and vaccination site pain were also reported as events. At the time of the report, events were resolving. Events seriousness captured as per IME list. Adalimumab was reported as a co-suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.