Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Product dose omission issue
Clinical narrative: Inappropriate schedule of vaccine; neuropathy symptoms; shock like sensation; tingling in hands and feet; progressed to tingling pain; burning sensation; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (neuropathy symptoms), ELECTRIC SHOCK SENSATION (shock like sensation), PARAESTHESIA (tingling in hands and feet), PAIN (progressed to tingling pain) and BURNING SENSATION (burning sensation) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced NEUROPATHY PERIPHERAL (neuropathy symptoms), ELECTRIC SHOCK SENSATION (shock like sensation), PARAESTHESIA (tingling in hands and feet), PAIN (progressed to tingling pain) and BURNING SENSATION (burning sensation). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Inappropriate schedule of vaccine). At the time of the report, NEUROPATHY PERIPHERAL (neuropathy symptoms), ELECTRIC SHOCK SENSATION (shock like sensation), PARAESTHESIA (tingling in hands and feet), PAIN (progressed to tingling pain) and BURNING SENSATION (burning sensation) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Inappropriate schedule of vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Medical History reported. Patient reported experiencing neuropathy symptoms which included tingling in hands and feet which progressed to tingling pain, shock-like sensation, and burning sensation starting a week and a half after getting the first dose. Patient reports her doctor just prescribed her with steroids but she hasn't taken them yet. Patient did not receive the second dose of the Moderna vaccine.  This case concerns  Product dose omission issue in a 30 year-old female patient with no reported medical history, who experienced the unexpected non-serious event of neuropathy symptoms. The event occurred an unknown number of days after the first dose of mRNA-1273 vaccine. The patient did not receive the second dose of vaccine. Manual override was done to remove Medically significant seriousness criteria based on medical judgement and review of source document that did not include information supporting the seriousness criteria. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This case concerns  Product dose omission issue in a 30 year-old female patient with no reported medical history, who experienced the unexpected non-serious event of neuropathy symptoms. The event occurred an unknown number of days after the first dose of mRNA-1273 vaccine. The patient did not receive the second dose of vaccine. Manual override was done to remove Medically significant seriousness criteria based on medical judgement and review of source document that did not include information supporting the seriousness criteria. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.