Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Inappropriate schedule of product administration, Neuritis
Clinical narrative: Diagnosed with Tubular Neuritis after 2nd booster,Very Dizzy 2 days after 2nd booster; first and second dose were administered with an interval of 42 days; Sick to stomach 2 days after 2nd booster; This spontaneous case was reported by a patient and describes the occurrence of NEURITIS (Diagnosed with Tubular Neuritis after 2nd booster,Very Dizzy 2 days after 2nd booster) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L21B, 051F21A, 013A21A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ABDOMINAL DISCOMFORT (Sick to stomach 2 days after 2nd booster). On 29-Apr-2022, the patient experienced NEURITIS (Diagnosed with Tubular Neuritis after 2nd booster,Very Dizzy 2 days after 2nd booster) (seriousness criterion hospitalization). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first and second dose were administered with an interval of 42 days). The patient was hospitalized from 29-Apr-2022 to 03-May-2022 due to NEURITIS. On 29-Apr-2022, ABDOMINAL DISCOMFORT (Sick to stomach 2 days after 2nd booster) had resolved. At the time of the report, NEURITIS (Diagnosed with Tubular Neuritis after 2nd booster,Very Dizzy 2 days after 2nd booster) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first and second dose were administered with an interval of 42 days) had resolved.            No concomitant medications were reported. Two days after 2nd booster she  was very dizzy and sick to stomach which lasted for 5 days. On 08JUN2022, almost 7 weeks after the 2nd booster, she was still Dizzy. She went to the Hospital on 29APR2022 for Dizziness, and was Hospitalized for 5 days. They diagnosed her with Tubular Neuritis.   No treatment medications were reported.  Company Comment: This is a Spontaneous case concerning an 80-year-old female patient, with no medical history reported, who experienced the unexpected and serious (due to hospitalization) event of Neuritis, which occurred 1 week after the fourth dose of mRNA-1273 vaccine. Patient reported that 2 days after the fourth dose of mRNA-1273 vaccine, she was very dizzy and sick to stomach, which lasted for 5 days. She went to the hospital 1 week after vaccination for dizziness, where she was diagnosed with tubular neuritis and was hospitalized for 5 days. No information disclosed about diagnostic tests performed or treatments received. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case concerning an 80-year-old female patient, with no medical history reported, who experienced the unexpected and serious (due to hospitalization) event of Neuritis, which occurred 1 week after the fourth dose of mRNA-1273 vaccine. Patient reported that 2 days after the fourth dose of mRNA-1273 vaccine, she was very dizzy and sick to stomach, which lasted for 5 days. She went to the hospital 1 week after vaccination for dizziness, where she was diagnosed with tubular neuritis and was hospitalized for 5 days. No information disclosed about diagnostic tests performed or treatments received. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.