Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Hypoaesthesia, Neuropathy peripheral, Paraesthesia, Product dose omission issue
Clinical narrative: did not receive second dose; She was diagnosed with neuropathy in her feet, experiencing on top of feet as well; Within a month or two after the shot she developed burning tingling and numbness in feet; Within a month or two after the shot she developed burning tingling and numbness in feet; Within a month or two after the shot she developed burning tingling and numbness in feet; This spontaneous case was reported by a physician and describes the occurrence of NEUROPATHY PERIPHERAL (She was diagnosed with neuropathy in her feet, experiencing on top of feet as well), HYPOAESTHESIA (Within a month or two after the shot she developed burning tingling and numbness in feet), BURNING SENSATION (Within a month or two after the shot she developed burning tingling and numbness in feet), PARAESTHESIA (Within a month or two after the shot she developed burning tingling and numbness in feet) and PRODUCT DOSE OMISSION ISSUE (did not receive second dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced NEUROPATHY PERIPHERAL (She was diagnosed with neuropathy in her feet, experiencing on top of feet as well), HYPOAESTHESIA (Within a month or two after the shot she developed burning tingling and numbness in feet), BURNING SENSATION (Within a month or two after the shot she developed burning tingling and numbness in feet) and PARAESTHESIA (Within a month or two after the shot she developed burning tingling and numbness in feet). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not receive second dose). At the time of the report, NEUROPATHY PERIPHERAL (She was diagnosed with neuropathy in her feet, experiencing on top of feet as well), HYPOAESTHESIA (Within a month or two after the shot she developed burning tingling and numbness in feet), BURNING SENSATION (Within a month or two after the shot she developed burning tingling and numbness in feet) and PARAESTHESIA (Within a month or two after the shot she developed burning tingling and numbness in feet) had not resolved and PRODUCT DOSE OMISSION ISSUE (did not receive second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication include Nature-throid, treatment to the events were not reported. The caller wanted to know that  his wife can receive a second dose of the Moderna COVID-19 vaccine given her side effects. vaccination facility   Company comment- This is a case of product dose omission issue of this 67-year-old, female patient, with no disclosed medical history, who experienced the non-serious, unexpected events of neuropathy peripheral, hypoesthesia, burning sensation, and paresthesia. The events occurred  on unknown date after first dose of Moderna vaccine. The rechallenge is not applicable as patient did not receive second dose. The benefit-risk relationship of Moderna vaccine is not affected by this report. Event neuropathy peripheral was automatically upgraded as serious as per IME list. However, based on information available and as per medical judgement (not disabling, no hospitalization) was assessed as non-serious.; Sender's Comments: This is a case of product dose omission issue of this 67-year-old, female patient, with no disclosed medical history, who experienced the non-serious, unexpected events of neuropathy peripheral, hypoesthesia, burning sensation, and paresthesia. The events occurred  on unknown date after first dose of Moderna vaccine. The rechallenge is not applicable as patient did not receive second dose. The benefit-risk relationship of Moderna vaccine is not affected by this report. Event neuropathy peripheral was automatically upgraded as serious as per IME list. However, based on information available and as per medical judgement (not disabling, no hospitalization) was assessed as non-serious.