Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Fatigue, Hypersomnia, Intentional product use issue
Clinical narrative: Intentional deviation from dosage regimen; fell twice; scrapped up her arms due to her fall; stability while walking due the neuropathy that ,possibly, might have been aggravated after the first dose; dizzy; slept a lot; really tired for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (stability while walking due the neuropathy that ,possibly, might have been aggravated after the first dose) in a 58-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.     The patient's past medical history included Fall (falls due to neuropathy). Concurrent medical conditions included Gout and Neuropathy peripheral (neuropathy in her feet).    On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced DIZZINESS (dizzy), HYPERSOMNIA (slept a lot) and FATIGUE (really tired for 3 days). In September 2021, the patient experienced NEUROPATHY PERIPHERAL (stability while walking due the neuropathy that ,possibly, might have been aggravated after the first dose) (seriousness criterion medically significant). On an unknown date, the patient experienced FALL (fell twice), LIMB INJURY (scrapped up her arms due to her fall) and INTENTIONAL PRODUCT USE ISSUE (Intentional deviation from dosage regimen). In August 2021, DIZZINESS (dizzy), HYPERSOMNIA (slept a lot) and FATIGUE (really tired for 3 days) had resolved. At the time of the report, NEUROPATHY PERIPHERAL (stability while walking due the neuropathy that ,possibly, might have been aggravated after the first dose) had not resolved, FALL (fell twice) and LIMB INJURY (scrapped up her arms due to her fall) outcome was unknown and INTENTIONAL PRODUCT USE ISSUE (Intentional deviation from dosage regimen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product information were provided by the reporter.  No treatment information was provided by the reporter.  The reporter said she is due for her second dose, which she is planning to skip since she has developed some symptoms.  Patient was been a week and half since has been feeling tingling, numbness in her feet up to her calves, worse sensation, dose not have good balance and stability while walking  Company Comment : This case concerns a 58-year-old female patient with a previous relevant medical history of Peripheral Neuropathy, who experienced the unexpected event of Peripheral neuropathy aggravated after Spikevax (mRNA- 1273 vaccine). Additionally, Intentional deviation from dosage regimen was captured. The onset of the events occurred approximately 13 days after the first dose of Spikevax. The rechallenge was not applicable since only information about the first dose was disclosed. Previous history of Peripheral Neuropathy remains a confounder. The benefit-risk relationship of Spikevax vaccine is not affected by this report.; Sender's Comments: This case concerns a 58-year-old female patient with a previous relevant medical history of Peripheral Neuropathy, who experienced the unexpected event of Peripheral neuropathy aggravated after Spikevax (mRNA- 1273 vaccine). Additionally, Intentional deviation from dosage regimen was captured. The onset of the events occurred approximately 13 days after the first dose of Spikevax. The rechallenge was not applicable since only information about the first dose was disclosed. Previous history of Peripheral Neuropathy remains a confounder. The benefit-risk relationship of Spikevax vaccine is not affected by this report.