Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Tremor
Clinical narrative: Diagnosed with Parkinson's Disease; This spontaneous case was reported by a patient and describes the occurrence of PARKINSON'S DISEASE (Diagnosed with Parkinson's Disease) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032?220A, 03910-2A, 032120A and 0391-2A) for COVID-19 vaccination.     Family history included Parkinson's disease (Father had Parkinson's disease). Concomitant products included PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]) and ATORVASTATIN for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced PARKINSON'S DISEASE (Diagnosed with Parkinson's Disease) (seriousness criterion medically significant). The patient was treated with PRIMIDONE for Tremor, at an unspecified dose and frequency. At the time of the report, PARKINSON'S DISEASE (Diagnosed with Parkinson's Disease) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient's medical history was not reported. After the very first primary shot, patient started having Tremors and stated that termors never went away, tremors continued with the same intensity after subsequent shots. The patient not started on any medications for Parkinson's Disease. The patient was prescribed with Primidone for Tremors but it did not help. It was reported that the doctor did a test looking for Parkinson's Gene and patient did not have the Parkinson's gene and sub-genes.  Company comment:  This spontaneous case concerns a 75-year-old female patient with concomitant use Paroxetine hydrochloride (PAXIL), who experienced the unexpected serious (medically significant) event of Parkinson's Disease on an unknown date after receiving the fourth dose of mRNA-1273 vaccine. Patient previously received 3 doses of mRNA-1273 vaccine consisting of a 2-dose primary series followed by first booster dose prior to current vaccine. Patient initially presented with tremors after the first dose of mRNA-1273 vaccine that continued with the same intensity after subsequent shots. Patient was diagnosed with Parkinson's disease approximately one month after current mRNA-1273 vaccination. Patient was not started on any medications for Parkinson's disease but was prescribed Primidone for tremors with no improvement.  The concomitant use Paroxetine hydrochloride (PAXIL) may contribute to the tremors of the patient. Though patient presented with family history of Parkinson's disease, tests conducted showed that patient did not have the Parkinson's gene and sub-genes. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-572193, MOD-2022-572224, MOD-2022-572261 (Patient Link).; Sender's Comments: This spontaneous case concerns a 75-year-old female patient with concomitant use Paroxetine hydrochloride (PAXIL), who experienced the unexpected serious (medically significant) event of Parkinson's Disease on an unknown date after receiving the fourth dose of mRNA-1273 vaccine. Patient previously received 3 doses of mRNA-1273 vaccine consisting of a 2-dose primary series followed by first booster dose prior to current vaccine. Patient initially presented with tremors after the first dose of mRNA-1273 vaccine that continued with the same intensity after subsequent shots. Patient was diagnosed with Parkinson's disease approximately one month after current mRNA-1273 vaccination. Patient was not started on any medications for Parkinson's disease but was prescribed Primidone for tremors with no improvement.  The concomitant use Paroxetine hydrochloride (PAXIL) may contribute to the tremors of the patient. Though patient presented with family history of Parkinson's disease, tests conducted showed that patient did not have the Parkinson's gene and sub-genes. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.