Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Paraesthesia, Pruritus, SARS-CoV-2 test, Tremor
Clinical narrative: terrible spasticity where muscles were constantly contracting becoming very stiff and hard in mainly legs, arm and torso which felt like it was strangling him to death; Terrible muscle spasm; Once the neuropathy started, the sensation in feet are like painful quick pin pricks that come and go, very brief; Sore throat sometimes; About a week later, woke up one morning with an excruciating headache and felt terrible again; A few weeks into it all, they started being very cold, hands especially fingers and toes were very very cold; whole body vibrates and they feel like if they put their hand on their leg, it makes them feel like they are vibrating, like a slight tremor to it; One night he woke up with his knees and elbow, excruciating burning pain, which has spread to hips, shoulders, ankles and wrists which they still deal with constantly; Then hands started hurting a lot. A lot of issues with joints in their hands, sometimes both hands and fingers. Severe pain in joints in hands; a lot of irregular heartbeats; Blood pressure swings that were dramatic, 150 over 90 and then the next day it might be 82 over 55; A lot of body aches; In the middle of Jul2022 caller started having sensations of neuralgia where their skin was painful, itchy skin on legs and arm; In the middle of Jul2022 caller started having sensations of neuralgia where their skin was painful, itchy skin on legs and arm; In May 2022, caller had a business trip and got Covid; Early Mar2022, a few toes in right foot started turning numb then all toes, then left foot and feet started hurting, extremely numbness and neuropathy.; Early Mar2022, a few toes in right foot started turning numb then all toes, then left foot and feet started hurting, extremely numbness and neuropathy; For several days he felt very very fatigued; For several days he felt typical flu symptoms,; For several days he felt absolutely no energy; He got sick that night on 30-Dec-2021 and could barely get out of bed for days; heart palpitations; This spontaneous case was reported by a patient and describes the occurrence of NEUROPATHY PERIPHERAL (Early Mar2022, a few toes in right foot started turning numb then all toes, then left foot and feet started hurting, extremely numbness and neuropathy) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (Dose 1) on 31-Mar-2021 and Pfizer vaccine (Dose 2) on 05-May-2021; for Drug use for unknown indication: Penicillin. Past adverse reactions to the above products included Adverse reaction with Penicillin; and No adverse event with Pfizer vaccine and Pfizer vaccine. Concurrent medical conditions included Esophageal acid reflux, Blood pressure high, Blood cholesterol and Hypothyroidism. Concomitant products included ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]) for Cholesterol, LEVOTHYROXINE for Hypothyroidism.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced ILLNESS (He got sick that night on 30-Dec-2021 and could barely get out of bed for days), PALPITATIONS (heart palpitations), ASTHENIA (For several days he felt absolutely no energy), INFLUENZA (For several days he felt typical flu symptoms,) and FATIGUE (For several days he felt very very fatigued). In March 2022, the patient experienced NEUROPATHY PERIPHERAL (Early Mar2022, a few toes in right foot started turning numb then all toes, then left foot and feet started hurting, extremely numbness and neuropathy) (seriousness criterion medically significant) and HYPOAESTHESIA (Early Mar2022, a few toes in right foot started turning numb then all toes, then left foot and feet started hurting, extremely numbness and neuropathy.). In May 2022, the patient experienced COVID-19 (In May 2022, caller had a business trip and got Covid). In July 2022, the patient experienced NEURALGIA (In the middle of Jul2022 caller started having sensations of neuralgia where their skin was painful, itchy skin on legs and arm) and PRURITUS (In the middle of Jul2022 caller started having sensations of neuralgia where their skin was painful, itchy skin on legs and arm). On an unknown date, the patient experienced MUSCLE SPASTICITY (terrible spasticity where muscles were constantly contracting becoming very stiff and hard in mainly legs, arm and torso which felt like it was strangling him to death), MUSCLE SPASMS (Terrible muscle spasm), PARAESTHESIA (Once the neuropathy started, the sensation in feet are like painful quick pin pricks that come and go, very brief), OROPHARYNGEAL PAIN (Sore throat sometimes), HEADACHE (About a week later, woke up one morning with an excruciating headache and felt terrible again), FEELING COLD (A few weeks into it all, they started being very cold, hands especially fingers and toes were very very cold), TREMOR (whole body vibrates and they feel like if they put their hand on their leg, it makes them feel like they are vibrating, like a slight tremor to it), PAIN (One night he woke up with his knees and elbow, excruciating burning pain, which has spread to hips, shoulders, ankles and wrists which they still deal with constantly), ARTHRALGIA (Then hands started hurting a lot. A lot of issues with joints in their hands, sometimes both hands and fingers. Severe pain in joints in hands), HEART RATE IRREGULAR (a lot of irregular heartbeats), BLOOD PRESSURE FLUCTUATION (Blood pressure swings that were dramatic, 150 over 90 and then the next day it might be 82 over 55) and MYALGIA (A lot of body aches). At the time of the report, NEUROPATHY PERIPHERAL (Early Mar2022, a few toes in right foot started turning numb then all toes, then left foot and feet started hurting, extremely numbness and neuropathy), MUSCLE SPASTICITY (terrible spasticity where muscles were constantly contracting becoming very stiff and hard in mainly legs, arm and torso which felt like it was strangling him to death), MUSCLE SPASMS (Terrible muscle spasm), NEURALGIA (In the middle of Jul2022 caller started having sensations of neuralgia where their skin was painful, itchy skin on legs and arm), PARAESTHESIA (Once the neuropathy started, the sensation in feet are like painful quick pin pricks that come and go, very brief), ILLNESS (He got sick that night on 30-Dec-2021 and could barely get out of bed for days), OROPHARYNGEAL PAIN (Sore throat sometimes), HEADACHE (About a week later, woke up one morning with an excruciating headache and felt terrible again), PALPITATIONS (heart palpitations), FEELING COLD (A few weeks into it all, they started being very cold, hands especially fingers and toes were very very cold), TREMOR (whole body vibrates and they feel like if they put their hand on their leg, it makes them feel like they are vibrating, like a slight tremor to it), PRURITUS (In the middle of Jul2022 caller started having sensations of neuralgia where their skin was painful, itchy skin on legs and arm), PAIN (One night he woke up with his knees and elbow, excruciating burning pain, which has spread to hips, shoulders, ankles and wrists which they still deal with constantly), COVID-19 (In May 2022, caller had a business trip and got Covid), ASTHENIA (For several days he felt absolutely no energy), ARTHRALGIA (Then hands started hurting a lot. A lot of issues with joints in their hands, sometimes both hands and fingers. Severe pain in joints in hands), HYPOAESTHESIA (Early Mar2022, a few toes in right foot started turning numb then all toes, then left foot and feet started hurting, extremely numbness and neuropathy.), INFLUENZA (For several days he felt typical flu symptoms,), FATIGUE (For several days he felt very very fatigued) and MYALGIA (A lot of body aches) had not resolved and HEART RATE IRREGULAR (a lot of irregular heartbeats) and BLOOD PRESSURE FLUCTUATION (Blood pressure swings that were dramatic, 150 over 90 and then the next day it might be 82 over 55) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: blood pressure swings that were dramatic, 150 over 90 and then the next day it might be 82 over 55. On an unknown date, Heart rate: a lot of irregular heartbeats. On an unknown date, SARS-CoV-2 test: Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient was taking a PPI off and on when needed. Patient takes a medication for blood pressure.  Patient went to the EENT. They got a strong antibiotic and steroids and that made him feel better off and on for a while. A few weeks into it all, they started being very cold, hands especially fingers and toes were very very cold. They have never had that problem before. Then hands started hurting a lot. A lot of issues with joints in their hands, sometimes both hands and fingers. Severe pain in joints in hands. Through most of it, patient had excruciating headaches off and on and it would sometimes last for days. Patient had major issues with brain fog, mental focus, it's a recurring issue and does not seem to be getting better. It was a dramatic change. Difficulty finishing tasks. Early Mar 2022, a few toes in right foot started turning numb then all toes, then left foot and feet started hurting, extremely numbness and neuropathy. Issues in hand started about the same time. Eventually went to check for nerve damage. Patient had to endure the pain and the numbness. It's came and gone, but sometimes worse than others. Patient went to a neurologist who gave a very strong dose of steroid and muscle relaxer which made them subside. Patient had multiple sclerosis so they had a spinal MRI but they confirmed he did not have it. The muscles spasms stopped after a few weeks. The steroids made him feel pretty good and normal. Patient was still left with neuralgia, headaches, burning pain in joints, terrible in their knees, some neuropathy but some has improved. Cold fingers and hands were constant and has gotten worse. Patient started having heart issues, blood pressure swings that were dramatic, 150 over 90 and then the next day it might be 82 over 55, heart palpitations, a lot of irregular heartbeats, whole body vibrates, and they feel like if they put their hand on their leg, it makes him felt like they are vibrating, like a slight tremor to it.   Company comment:  This is a spontaneous case concerning a 61-year-old male patient with a history of Blood pressure high, Blood cholesterol and Hypothyroidism, who experienced the serious (due to medically significant) unexpected, event of Neuropathy peripheral, which occurred approximately 3 months after a dose of mRNA-1273 vaccine, received as the third dose of COVID-19 vaccination schedule, together with other non-serious events. Doses 1 and 2 were with Pfizer COVID-19 vaccine. The mentioned medical history remains as confounders for non-serious events palpitations, Blood pressure fluctuation, asthenia, fatigue. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.