Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Incorrect route of product administration, Memory impairment, Parkinson's disease, Somnolence
Clinical narrative: FORGETFUL; Not himself; Sleepy; USE ERROR INFUSED MEDICATION VIA G-TUBE/ PUMP WAS CONNECTED TO G-TUBE INSTEAD OF J-TUBE; PARKINSON DISEASE SYMPTOMS; This spontaneous case was reported by a consumer and describes the occurrence of PARKINSON'S DISEASE (PARKINSON DISEASE SYMPTOMS) in a 72-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product CARBIDOPA, LEVODOPA (DUOPA) gastroenteral suspension for an unknown indication.    The patient's past medical history included Speech disorder (In 2021, the patient experienced speech unclear) in 2021, Colon operation in 2010 and Pacemaker insertion (cardiac) in 2018. Concurrent medical conditions included Diabetic since 2010 and Insect bite allergy. Concomitant products included CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), HYDROXYUREA, TAMSULOSIN HYDROCHLORIDE (TAMSULOSINE [TAMSULOSIN HYDROCHLORIDE]), FUROSEMIDE SODIUM (LASIX [FUROSEMIDE SODIUM]), UBIDECARENONE (COENZYME Q 10), SOLIFENACIN SUCCINATE (VESICARE), TERBINAFINE HCL, LEVOTHYROXINE SODIUM (SYNTHROID), FINASTERIDE, ROSUVASTATIN CALCIUM (CRESTOR), ASPIRIN [ACETYLSALICYLIC ACID], VITAMIN D3 and RANOLAZINE (RANEXA [RANOLAZINE]) for an unknown indication.   On 12-Feb-2020, the patient started CARBIDOPA, LEVODOPA (DUOPA) (unknown route) at an unspecified dose. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jun-2022, the patient experienced PARKINSON'S DISEASE (PARKINSON DISEASE SYMPTOMS) (seriousness criterion medically significant) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (USE ERROR INFUSED MEDICATION VIA G-TUBE/ PUMP WAS CONNECTED TO G-TUBE INSTEAD OF J-TUBE). On an unknown date, the patient experienced MEMORY IMPAIRMENT (FORGETFUL), FEELING ABNORMAL (Not himself) and SOMNOLENCE (Sleepy). In June 2022, PARKINSON'S DISEASE (PARKINSON DISEASE SYMPTOMS) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (USE ERROR INFUSED MEDICATION VIA G-TUBE/ PUMP WAS CONNECTED TO G-TUBE INSTEAD OF J-TUBE) had resolved. At the time of the report, MEMORY IMPAIRMENT (FORGETFUL), FEELING ABNORMAL (Not himself) and SOMNOLENCE (Sleepy) had resolved.            Patient was non tobacco user and Abstains from Alcohol.  Route of administration for the Co-Suspect drug CARBIDOPA, LEVODOPA (DUOPA) was Percutaneous.    Treatment Drug was not provided.  Company Comment: This is an spontaneous case concerning a 72-years-old male patient with relevant medical history of speech unclear, medicated with tamsulosine, solifenacine and levodopa, who experienced the Serious Medically significant unexpected event of Parkinson disease; additionally, other non-serious adverse events were reported as Memory impairment, Feeling abnormal and somnolence that may suggest being in connection with the serious adverse event. Also, the special situation event of Product administration error was reported in this case. The event occurred in an unknown date in the context of the 2nd.  dose of mRNA-1273 vaccine. The concomitant use of levodopa suggests an underlying condition of Parkinson disease that remain as a confounder for this event. The concomitant use of tamsulosine and solifenacine  remain as a contributor for the event of somnolence. In 2021, the patient experienced speech unclear.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is an spontaneous case concerning a 72-years-old male patient with relevant medical history of speech unclear, medicated with tamsulosine, solifenacine and levodopa, who experienced the Serious Medically significant unexpected event of Parkinson disease; additionally, other non-serious adverse events were reported as Memory impairment, Feeling abnormal and somnolence that may suggest being in connection with the serious adverse event. Also, the special situation event of Product administration error was reported in this case. The event occurred in an unknown date in the context of the 2nd.  dose of mRNA-1273 vaccine. The concomitant use of levodopa suggests an underlying condition of Parkinson disease that remain as a confounder for this event. The concomitant use of tamsulosine and solifenacine  remain as a contributor for the event of somnolence. In 2021, the patient experienced speech unclear.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.