Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neuropathy peripheral, Pain, Paraesthesia, Peripheral swelling
Clinical narrative: low blood pressure; Tremor/Shaking; Vertigo; Brain Fog; Swollen legs when standing; Insomnia/Interrupted sleep pattern; Muscle Spasm; Electric shocks; Tingling sensation; Noise sensitivity; Light sensitivity; Occasional Vision changes; Irritating pain/light touch is irritating or painful; Floppy reflex; Dizziness; Nausea; extreme/chronic fatigue; Headaches/light headedness; Neuropathy; Somedays she cannot get up from bed because of these symptoms other days she can just be sitting on the table; Feeling chest; Awful shortness of breath; Her heart rate was going everywhere; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy), DECREASED ACTIVITY (Somedays she cannot get up from bed because of these symptoms other days she can just be sitting on the table), CHEST DISCOMFORT (Feeling chest), DYSPNOEA (Awful shortness of breath) and HEART RATE ABNORMAL (Her heart rate was going everywhere) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), VITAMIN B NOS and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced CHEST DISCOMFORT (Feeling chest), DYSPNOEA (Awful shortness of breath) and HEART RATE ABNORMAL (Her heart rate was going everywhere). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy), DECREASED ACTIVITY (Somedays she cannot get up from bed because of these symptoms other days she can just be sitting on the table), HYPOTENSION (low blood pressure), TREMOR (Tremor/Shaking), VERTIGO (Vertigo), FEELING ABNORMAL (Brain Fog), PERIPHERAL SWELLING (Swollen legs when standing), INSOMNIA (Insomnia/Interrupted sleep pattern), MUSCLE SPASMS (Muscle Spasm), ELECTRIC SHOCK SENSATION (Electric shocks), PARAESTHESIA (Tingling sensation), HYPERACUSIS (Noise sensitivity), PHOTOPHOBIA (Light sensitivity), VISUAL IMPAIRMENT (Occasional Vision changes), PAIN (Irritating pain/light touch is irritating or painful), HYPOTONIA (Floppy reflex), DIZZINESS (Dizziness), NAUSEA (Nausea), FATIGUE (extreme/chronic fatigue) and HEADACHE (Headaches/light headedness). The patient was treated with FLUDROCORTISONE for Adverse event, at an unspecified dose and frequency; METOPROLOL TARTRATE for Adverse event, at an unspecified dose and frequency; THIAMINE for Adverse event, at an unspecified dose and frequency; CALCIUM ACETATE for Adverse event, at an unspecified dose and frequency; ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Adverse event, at an unspecified dose and frequency; BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy), DECREASED ACTIVITY (Somedays she cannot get up from bed because of these symptoms other days she can just be sitting on the table), CHEST DISCOMFORT (Feeling chest), DYSPNOEA (Awful shortness of breath), HEART RATE ABNORMAL (Her heart rate was going everywhere), HYPOTENSION (low blood pressure), TREMOR (Tremor/Shaking), VERTIGO (Vertigo), FEELING ABNORMAL (Brain Fog), PERIPHERAL SWELLING (Swollen legs when standing), INSOMNIA (Insomnia/Interrupted sleep pattern), MUSCLE SPASMS (Muscle Spasm), ELECTRIC SHOCK SENSATION (Electric shocks), PARAESTHESIA (Tingling sensation), HYPERACUSIS (Noise sensitivity), PHOTOPHOBIA (Light sensitivity), VISUAL IMPAIRMENT (Occasional Vision changes), PAIN (Irritating pain/light touch is irritating or painful), HYPOTONIA (Floppy reflex), DIZZINESS (Dizziness), NAUSEA (Nausea), FATIGUE (extreme/chronic fatigue) and HEADACHE (Headaches/light headedness) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: low low blood pressure.          No medical history was reported. Somedays patient cannot get up from bed because of these symptoms other days she can just be sitting on the table, the symptoms get better but never go away. Patient wears compression stockings all the time for her low blood pressure. Because of these symptoms patient visited the doctor who was cardiologist and they prescribed medication and ran some tests to check the heart function. The doctor said that patient heart had not a problem. But reporter confirms that the patient had not had COVID19 infection and neither has been diagnosed with myocarditis nor pericarditis. Treatment, Compression stockings. Company comment: This case concerns a 38-year-old female patient with no medical history provided, who experienced non serious unexpected events of Neuropathy peripheral (reported as neuropathy), Chest discomfort, Dyspnoea, Decreased activity ,Hypotension, Tremor, Vertigo, Feeling abnormal, Peripheral swelling, Insomnia, Muscle spasms, Heart rate abnormal, Electric shock sensation, Paraesthesia, Hyperacusis, Photophobia, Visual impairment, Pain and Hypotonia, as well as non serious expected events of Headache, Dizziness, Nausea, Fatigue. The events of Chest discomfort, Dyspnoea and Heart rate abnormal occurred during the same day (within 24 hours) after the patient had received the second dose of the mRNA-1273 vaccine. The exact start date for the remaining events was not provided. The patient developed and tremors, shaking, low blood pressure, lightheadedness, vertigo, dizziness, brain fog, swollen legs when standing, nausea, insomnia and interrupted sleep pattern, extreme/chronic fatigue, muscle spasm, electric shocks sensation, tingling sensation, noise and light sensitivity, neuropathy, occasional vision changes, irritating pain (event light touch was irritating or painful), floppy reflex and headaches. On some days the patient could not get up from bed because of the symptoms, and other days she could just be sitting on the table. It was stated that the symptoms get better but never went away. The patient visited the cardiologist who confirmed that the patient's heart function was normal. The patient was treated with Fludcortisone, Metoprolol tartrate, thiamine, calcium acetate, Excedrin, salt tablets, Benadryl, Pepto Bismol, Tylenol, Advil and Compression stockings. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. The event of Neuropathy peripheral is on list, however, as per case description and based on medical judgement, the event was assessed as non serious.   This case was linked to MOD-2022-473846 (Patient Link).; Sender's Comments: This case concerns a 38-year-old female patient with no medical history provided, who experienced non serious unexpected events of Neuropathy peripheral (reported as neuropathy), Chest discomfort, Dyspnoea, Decreased activity ,Hypotension, Tremor, Vertigo, Feeling abnormal, Peripheral swelling, Insomnia, Muscle spasms, Heart rate abnormal, Electric shock sensation, Paraesthesia, Hyperacusis, Photophobia, Visual impairment, Pain and Hypotonia, as well as non serious expected events of Headache, Dizziness, Nausea, Fatigue. The events of Chest discomfort, Dyspnoea and Heart rate abnormal occurred during the same day (within 24 hours) after the patient had received the second dose of the mRNA-1273 vaccine. The exact start date for the remaining events was not provided. The patient developed and tremors, shaking, low blood pressure, lightheadedness, vertigo, dizziness, brain fog, swollen legs when standing, nausea, insomnia and interrupted sleep pattern, extreme/chronic fatigue, muscle spasm, electric shocks sensation, tingling sensation, noise and light sensitivity, neuropathy, occasional vision changes, irritating pain (event light touch was irritating or painful), floppy reflex and headaches. On some days the patient could not get up from bed because of the symptoms, and other days she could just be sitting on the table. It was stated that the symptoms get better but never went away. The patient visited the cardiologist who confirmed that the patient's heart function was normal. The patient was treated with Fludcortisone, Metoprolol tartrate, thiamine, calcium acetate, Excedrin, salt tablets, Benadryl, Pepto Bismol, Tylenol, Advil and Compression stockings. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. The event of Neuropathy peripheral is on list, however, as per case description and based on medical judgement, the event was assessed as non serious.