Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Condition aggravated, Neuropathy peripheral
Clinical narrative: her neuropathy was also a bit worse after those doses/since then her neuropathy has been very exacerbated; her neuropathy was also a bit worse after those doses/since then her neuropathy has been very exacerbated; She had Covid-19 twice; She had Covid-19 twice; This spontaneous case was reported by a patient and describes the occurrence of NEUROPATHY PERIPHERAL (her neuropathy was also a bit worse after those doses/since then her neuropathy has been very exacerbated) and CONDITION AGGRAVATED (her neuropathy was also a bit worse after those doses/since then her neuropathy has been very exacerbated) in a 68-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. 012H21B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Neuropathy.    On 02-Dec-2021, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In 2022, the patient experienced the first episode of COVID-19 (She had Covid-19 twice). In June 2023, the patient experienced the second episode of COVID-19 (She had Covid-19 twice). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (her neuropathy was also a bit worse after those doses/since then her neuropathy has been very exacerbated) (seriousness criterion medically significant) and CONDITION AGGRAVATED (her neuropathy was also a bit worse after those doses/since then her neuropathy has been very exacerbated) (seriousness criterion medically significant). At the time of the report, NEUROPATHY PERIPHERAL (her neuropathy was also a bit worse after those doses/since then her neuropathy has been very exacerbated), CONDITION AGGRAVATED (her neuropathy was also a bit worse after those doses/since then her neuropathy has been very exacerbated) and the last episode of COVID-19 (She had Covid-19 twice) outcome was unknown.            It was reported that patient had no other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  It was reported that 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. She had Covid-19 twice, first episode on Summer of 2022 and second episode on Jun-2023. This was after receiving Moderna vaccines. It was not severe.  Treatment information was not provided.  Company Comment: This is a Spontaneous case concerning a 68-year-old female patient with relevant medical history of Diabetes and Neuropathy, who experienced the serious (per medically significant) unexpected events of Diabetes and Neuropathy which occurred after a dose of SPIKEVAX NOS received as the third dose for COVID-19 Vaccination. It was reported that her neuropathy was a bit worse after the doses, but it was not unbearable, she could deal with it. The mentioned medical history remains confounding. No further clinical information or diagnostic tests results were disclosed for analysis. No concomitant medication or treatment information was reported. The benefit-risk relationship of SPIKEVAX NOS is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-749431, US-MODERNATX, INC.-MOD-2023-749438 (E2B Linked Report). This case was linked to MOD-2023-749438, MOD-2023-749431 (Patient Link).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-749431:Same patient spikevax 2023-2024 vaccine US-MODERNATX, INC.-MOD-2023-749438:same patient Monovalent case