Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Neuropathy peripheral
Clinical narrative: Spikevax 2 weeks ago and since then her neuropathy has been very exacerbated; Spikevax 2 weeks ago and since then her neuropathy has been very exacerbated; This spontaneous case was reported by a patient and describes the occurrence of NEUROPATHY PERIPHERAL (Spikevax 2 weeks ago and since then her neuropathy has been very exacerbated) and CONDITION AGGRAVATED (Spikevax 2 weeks ago and since then her neuropathy has been very exacerbated) in a 68-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8059068) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (Patient had Covid-19 twice on Summer of 2022 and on June of 2023. This was after receiving Moderna vaccines. It wasn´t severe.). Concurrent medical conditions included Diabetes and Neuropathy.    On 02-Nov-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced NEUROPATHY PERIPHERAL (Spikevax 2 weeks ago and since then her neuropathy has been very exacerbated) (seriousness criterion medically significant) and CONDITION AGGRAVATED (Spikevax 2 weeks ago and since then her neuropathy has been very exacerbated) (seriousness criterion medically significant). At the time of the report, NEUROPATHY PERIPHERAL (Spikevax 2 weeks ago and since then her neuropathy has been very exacerbated) and CONDITION AGGRAVATED (Spikevax 2 weeks ago and since then her neuropathy has been very exacerbated) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. Patient received Spikevax 2 weeks ago and since then her neuropathy has been very exacerbated. She reported that she was certain that it was the vaccine because it has been worse since she had the vaccine. She experienced no other symptoms. She didn´t experience anything with the previous doses. Maybe her neuropathy was also a bit worse after those doses, but it was not unbearable, she could deal with it. But with this last shot, it was worse than ever, a lot worse. The treatment medication was not reported by reporter.  Company Comment: This is a Spontaneous case reported by a patient, concerning a 68-year-old female patient, with relevant medical conditions of neuropathy and diabetes, who experienced the unexpected and serious (due to medically significant) events of Neuropathy and Condition aggravated, which occurred after SPIKEVAX 2023-2024 vaccine, administered as fourth dose within COVID-19 vaccination schedule. As reported, since she received the vaccine, her neuropathy has been very exacerbated. She experienced no other symptoms. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the events had not resolved. Underlying diabetes and neuropathy could be risk factors for the events. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.   This case was linked to MOD-2023-749436, MOD-2023-749438 (Patient Link).   Reporter did not allow further contact