Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Gait inability, Intentional product use issue, Loss of personal independence in daily activities, Parkinson's disease
Clinical narrative: Did not get the second dose because of this symptoms; Symptoms of Parkinson's worsened after the shot; Felt weak/suddenly lost his strength and he needed to sit down or lay down; Couldn't even take a bath; Could not stand up or walk; This spontaneous case was reported by a consumer and describes the occurrence of PARKINSON'S DISEASE (Symptoms of Parkinson's worsened after the shot) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Parkinson's disease (since 6 years) since 2015. Concomitant products included CARBIDOPA, ENTACAPONE, LEVODOPA (CARBIDOPA, LEVODOPA AND ENTACAPONE), PRAMIPEXOL [PRAMIPEXOLE] and CARBIDOPA MONOHYDRATE, LEVODOPA (SINEMET) for Parkinson's disease, CIPROFLOXACIN HCL, ESCITALOPRAM, ENALAPRIL, TAMSULOSIN HCL and DONEPEZIL for an unknown indication.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced PARKINSON'S DISEASE (Symptoms of Parkinson's worsened after the shot) (seriousness criterion medically significant), ASTHENIA (Felt weak/suddenly lost his strength and he needed to sit down or lay down), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Couldn't even take a bath) and GAIT INABILITY (Could not stand up or walk). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Did not get the second dose because of this symptoms). In August 2021, GAIT INABILITY (Could not stand up or walk) had resolved. At the time of the report, PARKINSON'S DISEASE (Symptoms of Parkinson's worsened after the shot), ASTHENIA (Felt weak/suddenly lost his strength and he needed to sit down or lay down) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Couldn't even take a bath) was resolving and INTENTIONAL PRODUCT USE ISSUE (Did not get the second dose because of this symptoms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.  Patient stated that his Parkinson's disease was under control with medication prior to taking the vaccine. Post vaccination he would spend up to 8 hours in bed. His symptoms persisted till around 20-Jun-2021 when he started to get slowly better but had still not recovered 100%. Prior to vaccination, he would take his medications regularly and lived a normal life.   His doctor told him to get the second dose and was scheduled for the same on 31-Aug-2021.  Company comment: This report refers to a case of Intentional product use issue for mRNA-1273 (lot # 017C21A) with associated adverse events. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, more information is required for further assessment.; Sender's Comments: This report refers to a case of Intentional product use issue for mRNA-1273 (lot # 017C21A) with associated adverse events. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, more information is required for further assessment.