Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Neuropathy peripheral, Pyrexia
Clinical narrative: Neuropathy came back/Body was on fire /Nervous system on fire/Body pain/Shaking; Fever 101F; Severe Headache; Chill / had Shaking Chills; This spontaneous case was reported by a nurse and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy came back/Body was on fire /Nervous system on fire/Body pain/Shaking) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AG7144B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised and Crohn's disease (For the past 2 years. It was under control prior to receiving the Moderna COVID-19 Vaccine.).    On 03-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Nov-2022, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy came back/Body was on fire /Nervous system on fire/Body pain/Shaking) (seriousness criterion medically significant), PYREXIA (Fever 101F), HEADACHE (Severe Headache) and CHILLS (Chill / had Shaking Chills). On 17-Nov-2022, PYREXIA (Fever 101F), HEADACHE (Severe Headache) and CHILLS (Chill / had Shaking Chills) had resolved. At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy came back/Body was on fire /Nervous system on fire/Body pain/Shaking) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 F.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. On 07-APR-2021, the patient received first dose of Moderna COVID-19 vaccine of batch number 031B21A. On 05-MAY-2021, the patient received second dose of Moderna COVID-19 vaccine of batch number 027C21A. On 23-DEC-2021, the patient received third dose of Moderna COVID-19 vaccine booster of batch number 059H21A. No treatment information was provided.  Company Comment: This is a spontaneous case concerning  a  61-year-old, female patient with no relevant medical history, who experienced the unexpected (medically sgnificant) serious events of Neuropathy peripheral and expected non-serious events of Pyrexia, Headache, Chills. The events occurred on the same day after the fourth dose mRNA-1273.222 Vaccine.  No further details on clinical course and treatment received were reported. Outcome of the events Pyrexia Headache and Chills had resolved, while Neuropathy Pheriperal outcome was unknown. The benefit-risk relationship of mRNA-1273.222 Vaccine, is not affected by this report.   This case was linked to MOD-2022-677400, MOD-2022-677449 (Patient Link).; Sender's Comments: This is a spontaneous case concerning  a  61-year-old, female patient with no relevant medical history, who experienced the unexpected (medically sgnificant) serious events of Neuropathy peripheral and expected non-serious events of Pyrexia, Headache, Chills. The events occurred on the same day after the fourth dose mRNA-1273.222 Vaccine.  No further details on clinical course and treatment received were reported. Outcome of the events Pyrexia Headache and Chills had resolved, while Neuropathy Pheriperal outcome was unknown. The benefit-risk relationship of mRNA-1273.222 Vaccine, is not affected by this report.