Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Magnetic resonance imaging, Neuropathy peripheral, Pain, Positron emission tomogram
Clinical narrative: Severe neuropathy; feels the pain is affecting her entire lower body; Feeling pain in the spine; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Severe neuropathy) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced SPINAL PAIN (Feeling pain in the spine). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Severe neuropathy) (seriousness criterion medically significant) and PAIN (feels the pain is affecting her entire lower body). At the time of the report, NEUROPATHY PERIPHERAL (Severe neuropathy) outcome was unknown and SPINAL PAIN (Feeling pain in the spine) and PAIN (feels the pain is affecting her entire lower body) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: not reported (Inconclusive) No results were provided. On an unknown date, Magnetic resonance imaging: not reported (Inconclusive) No results were provided. On an unknown date, Positron emission tomogram: not reported (Inconclusive) No results were provided. On an unknown date, X-ray: not reported (Inconclusive) No results were provided.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient is on concomitant medication but she didn´t give any specifications about them.  Patient reported experiencing a severe neuropathy after receiving the Moderna Covid-19 Vaccine. The patient stated that immediately after receiving both doses of the vaccine, she started feeling pain in her spine. Now she feels the pain is affecting her entire lower body. This sensation is still ongoing.   The patient didn´t mention any treatment given, but stated she went to doctor´s and surgeon´s appointments, had blood tests performed, MRI, PET scans and X-rays.   No information was provided about how the patient second dose was administered. Expiration date of doses is unknown.  Company Comment: This case concerns a 53-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of neuropathy peripheral. The event occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was unknown since no information regarding the third dose was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-416118 (Patient Link).; Sender's Comments: This case concerns a 53-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of neuropathy peripheral. The event occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was unknown since no information regarding the third dose was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.