Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Disorientation, Fatigue, Feeling hot, Gait disturbance
Clinical narrative: heart beat greater than 100 beats per minute; Right heel itched at night/localized itching; Heart started pounding; Vomiting; Feeling hot; Decreased level of consciousness; Diarrhea; Nausea; Stomach ache worsened/ frighteneing stomach issues and cramps; Chills; peripheral neuropathy/Skin was tingling; Disoriented; Severe dehydration; Anxiety attack over lack of improvement/ panic attack over stress of situation; Fatigue/ chronic fatigue; Hard to walk/ Walking and moving became more difficult , unstable, and painful; Mild joint pain; Systemic allergic reaction; Sleep was nearly impossible/ did not sleep well; Headache/Congested with a severe headache; No appetite; Woke up feeling like I had the flu/ flu like symptoms; Shoulder soreness had become full body muscle aches/Constant full body pain/ full body aches/ systemic pain; injection site muscle soreness; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach ache worsened/ frighteneing stomach issues and cramps), CHILLS (Chills), VOMITING (Vomiting), FEELING HOT (Feeling hot), DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of consciousness), DIARRHOEA (Diarrhea), NAUSEA (Nausea), NEUROPATHY PERIPHERAL (peripheral neuropathy/Skin was tingling), HYPERSENSITIVITY (Systemic allergic reaction), INSOMNIA (Sleep was nearly impossible/ did not sleep well), ANXIETY (Anxiety attack over lack of improvement/ panic attack over stress of situation), MYALGIA (Shoulder soreness had become full body muscle aches/Constant full body pain/ full body aches/ systemic pain), ARTHRALGIA (Mild joint pain), FATIGUE (Fatigue/ chronic fatigue), HEADACHE (Headache/Congested with a severe headache), PALPITATIONS (Heart started pounding), TACHYCARDIA (heart beat greater than 100 beats per minute) and PRURITUS (Right heel itched at night/localized itching) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L204) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.  Patient did not had anaphylaxis, hypersensitivity reactions, hives/urticaria, asthma and hay fever. No previous history of allergic/hypersensitivity reactions to vaccines or other allergic/hypersensitivity reactions (medications, foods, environmental, etc.) were reported. There were no acute illnesses at the time of vaccination and up to one month before and no other chronic/long-standing health conditions. No prescriptions, over-the-counter medications, dietary supplements, or herbal remedies were taken at time of vaccination.  On 31-Dec-2020 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced VACCINATION SITE PAIN (injection site muscle soreness). On 01-Jan-2021, the patient experienced MYALGIA (Shoulder soreness had become full body muscle aches/Constant full body pain/ full body aches/ systemic pain) (seriousness criterion medically significant). On 02-Jan-2021, the patient experienced CHILLS (Chills) (seriousness criterion hospitalization), DECREASED APPETITE (No appetite) and INFLUENZA LIKE ILLNESS (Woke up feeling like I had the flu/ flu like symptoms). On 04-Jan-2021, the patient experienced HEADACHE (Headache/Congested with a severe headache) (seriousness criterion medically significant). On 07-Jan-2021, the patient experienced INSOMNIA (Sleep was nearly impossible/ did not sleep well) (seriousness criterion medically significant). On 08-Jan-2021, the patient experienced HYPERSENSITIVITY (Systemic allergic reaction) (seriousness criterion medically significant). On 11-Jan-2021, the patient experienced ARTHRALGIA (Mild joint pain) (seriousness criterion medically significant). On 17-Jan-2021, the patient experienced GAIT DISTURBANCE (Hard to walk/ Walking and moving became more difficult , unstable, and painful). On 21-Jan-2021, the patient experienced PALPITATIONS (Heart started pounding) (seriousness criterion hospitalization). On 22-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach ache worsened/ frighteneing stomach issues and cramps) (seriousness criterion hospitalization) and NAUSEA (Nausea) (seriousness criterion hospitalization). On 27-Jan-2021, the patient experienced PRURITUS (Right heel itched at night/localized itching) (seriousness criterion hospitalization). On 01-Feb-2021, the patient experienced FATIGUE (Fatigue/ chronic fatigue) (seriousness criterion medically significant). On 03-Mar-2021, the patient experienced ANXIETY (Anxiety attack over lack of improvement/ panic attack over stress of situation) (seriousness criterion medically significant). On 04-Mar-2021, the patient experienced DEHYDRATION (Severe dehydration). On 16-Mar-2021, the patient experienced DISORIENTATION (Disoriented). On an unknown date, the patient experienced VOMITING (Vomiting) (seriousness criterion hospitalization), FEELING HOT (Feeling hot) (seriousness criterion hospitalization), DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of consciousness) (seriousness criteria hospitalization and medically significant), DIARRHOEA (Diarrhea) (seriousness criterion hospitalization), NEUROPATHY PERIPHERAL (peripheral neuropathy/Skin was tingling) (seriousness criterion medically significant) and TACHYCARDIA (heart beat greater than 100 beats per minute) (seriousness criterion hospitalization). The patient was hospitalized from 05-May-2021 to 07-May-2021 due to ABDOMINAL PAIN UPPER, CHILLS, DEPRESSED LEVEL OF CONSCIOUSNESS, DIARRHOEA, FEELING HOT, NAUSEA and VOMITING. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) 08-Jan-2021 at a dose of 25 milligram; PREDNISONE (oral) from 14-Jan-2021 to 18-Jan-2021 for Muscle pain, at a dose of 20 milligram twice a day; IBUPROFEN at a dose of 400 milligram; GABAPENTIN ENACARBIL (HORIZANT) on 21-Jan-2021 at a dose of 600 milligram; PREGABALIN (LYRICA) on 26-Jan-2021 at a dose of 200 milligram; TRAMADOL at a dose of 100 milligram twice a day; HYDROXYCHLOROQUINE from 04-Feb-2021 to 11-Feb-2021 at a dose of 200 milligram twice a day; TESTOSTERONE on 15-Mar-2021 at a dose of 100 milligram two times per week; LORAZEPAM (ATIVAN) on 21-Jan-2021 for Anxiety, at a dose of 2 milligram as required; LORAZEPAM (ATIVAN) (intravenous) on 05-May-2021 for Anxiety, at a dose of 1 dosage form; ONDANSETRON (ZOFRAN [ONDANSETRON]) at a dose of 8 milligram as required; ONDANSETRON (ZOFRAN [ONDANSETRON]) (intravenous) 05-May-2021 at a dose of 1 dosage form; DESVENLAFAXINE SUCCINATE MONOHYDRATE (PRISTIQ) at a dose of 25 milligram once a day; ANASTROZOLE (ANASTRAZOLE DENK) at a dose of .5 milligram two times per week; CAMPHOR, MENTHOL (BIOFREEZE [CAMPHOR;MENTHOL]) at a dose of 1 dosage form; GLYCINE at a dose of 1000 milligram; ASCORBIC ACID, SODIUM ASCORBATE (LIPOSOMAL VITAMIN C) at a dose of 1600 milligram; MORPHINE (intravenous) 05-May-2021 for Pain, at a dose of 1 dosage form; ACETYLCYSTEINE (NAC [ACETYLCYSTEINE]) on 31-May-2021 for Pain, at a dose of 1000 milligram; DICLOFENAC (topical) for Pain, at a dose of 1 dosage form; MAGNESIUM on 24-Jun-2021 at a dose of 400 milligram and BUPROPION HYDROCHLORIDE (WELLBUTRIN) on 03-May-2021 for Depression, at a dose of 100 milligram. On 06-Jan-2021, HEADACHE (Headache/Congested with a severe headache) had resolved. On 22-Jan-2021, PALPITATIONS (Heart started pounding) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (Stomach ache worsened/ frighteneing stomach issues and cramps), HYPERSENSITIVITY (Systemic allergic reaction), INSOMNIA (Sleep was nearly impossible/ did not sleep well), ANXIETY (Anxiety attack over lack of improvement/ panic attack over stress of situation), TACHYCARDIA (heart beat greater than 100 beats per minute), PRURITUS (Right heel itched at night/localized itching), DEHYDRATION (Severe dehydration), GAIT DISTURBANCE (Hard to walk/ Walking and moving became more difficult , unstable, and painful), DISORIENTATION (Disoriented) and VACCINATION SITE PAIN (injection site muscle soreness) outcome was unknown, CHILLS (Chills), VOMITING (Vomiting), FEELING HOT (Feeling hot), DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of consciousness), DIARRHOEA (Diarrhea), NAUSEA (Nausea), NEUROPATHY PERIPHERAL (peripheral neuropathy/Skin was tingling), MYALGIA (Shoulder soreness had become full body muscle aches/Constant full body pain/ full body aches/ systemic pain), ARTHRALGIA (Mild joint pain) and FATIGUE (Fatigue/ chronic fatigue) had not resolved, DECREASED APPETITE (No appetite) was resolving and INFLUENZA LIKE ILLNESS (Woke up feeling like I had the flu/ flu like symptoms) had resolved with sequelae.     DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jan-2021, Body temperature: 97.9 97.9 degrees Fahrenheit. On 02-Jan-2021, Heart rate: 90 heart beats per minute. On 02-Jan-2021, Respiratory rate: 14 breaths per minute. On 06-Jan-2021, COVID-19: (Negative) Negative. On 06-Jan-2021, Influenza A virus test: (Negative) Negative. On 06-Jan-2021, Influenza B virus test: (Negative) negative. On 11-Jan-2021, COVID-19: (Negative) negative. On 11-Jan-2021, Influenza A virus test: (Negative) negative. On 11-Jan-2021, Influenza B virus test: (Negative) negative. On 11-Jan-2021, Urine analysis: Urinalysis showed severe dehydration.. On 14-Jan-2021, Blood pressure measurement: 139/103 mmHg. On 14-Jan-2021, Body temperature: 97.5 97.5 degrees Fahrenheit. On 14-Jan-2021, Heart rate: 66 heart beats per minute. On 14-Jan-2021, Respiratory rate: 14 breaths per minute. On 21-Jan-2021, Heart rate: 100 heart beats per minute Greater than 100 heart beats per minute. On 15-Mar-2021, Blood pressure measurement: 145/97 mmHg. On 15-Mar-2021, Body temperature: 97.6 97.6 degrees Fahrenheit. On 15-Mar-2021, Heart rate: 65 heart beats per minute. On 15-Mar-2021, Respiratory rate: 15 breaths per minute. On 03-Jun-2021, Blood pressure measurement: 156/105 mmHg. On 03-Jun-2021, Body temperature: 97.6 97.6 degrees Fahrenheit. On 03-Jun-2021, Heart rate: 88 heart beats per minute. On 03-Jun-2021, Respiratory rate: 18 breaths per minute.  mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No concomitant medications were reported. The patient continued to experience lower back, hips, legs and knees pain. He was advised by his physician not to take the second dose of vaccine. Blood tests ordered by the physician on 14-Jan-2021 did not reveal any signs of inflammation. On 29-Jan-2021, patient consulted an immunologist. Specialized blood tests, unspecified, were normal. On 24-Feb-2021, rheumatologist was consulted. Physical examination and blood tests were done. No abnormality was revealed. On 04-May-2021, annual work wellness test was done. Patient was treated with intravenous fluids as he was found to be dehydrated. Patient had therapy appointments at regular intervals with the doctor once or twice a week. On 03-Jun-2021, he had his first appointment with the worker's compensation doctor. He began physical therapy from 14-Jun-2021 which included pool therapy, stretch exercises, weight training exercises, and physical breathing techniques. On 23-Jun-2021, he had an appointment with the neurologist. MRI (magnetic resonance imaging) was done on 25-Jun-2021. Patient's condition aggravated, now walking with a cane, bad dreams, patient felt jittery, hard time regulating body temperature, was hot but feet were ice cold and sweating. Full blood panel completed by immunologist, routine blood paqnels completed by doctors, ER, and hospital. Treatment also included collagen peptides, ice pack, heating pads and weighted blanket. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Case was confounded by anxiety and polypharmacy. It had now been over a year since this information was sent. The patient was still suffering from his vaccine injury, peripheral neuropathy. Immunology results were available upon request. Have requested ER and hospital results from May but had not yet received them.  Company comment: This spontaneous case concerns a 48-year-old, male patient with no reported medical history, who experienced the unexpected, serious (hospitalization) event of abdominal pain upper, chills, vomiting, feeling hot, depressed level of consciousness, diarrhoea, nausea along with the unexpected serious (medically significant) neuropathy peripheral, hypersensitivity, insomnia, anxiety, myalgia, arthralgia, fatigue and headache. The patient experienced a series of symptoms over the course of 6 months after receiving the first dose of mRNA1273, the timeline of the serious events reported in this case are as follows : myalgia at 1 day, chills at 2 days, headache 4 days, insomnia 7 days, hypersensitivity at 8 days, arthralgia at 11 days, abdominal pain and nausea at 22 days, fatigue (chronic fatigue) at 1month and anxiety at 2 months post vaccination. The rest of the events occurred at an unknown interval after vaccination of mRNA1273. The patient reported that the symptoms started 1 day post vaccination, he started having muscle soreness on the injection site and spread to become full body muscle pain. The following day still with muscle pain the patient had chills along with loss of appetite and fatigue. 2 days later headache started. About 1 week post vaccination the symptoms still persist now with difficulty in falling asleep. A health care provider suggested that the patient may have systemic allergic reaction to the vaccine and was advised to take Benadryl 25mg, the patient noted that his muscle pain became worse but he did not seek medical care. At around 11 days the patient started having mild joint pain most noticeable at the hips and knees. The patient reported to be still taking medications for pain such as ibuprofen but was later prescribed with gabapentin enacarbil (horizant), pregabalin (lyrica) and tramadol for better management. He was also treated with lorazepam (Ativan) for the difficulty sleeping and anxiety. Along with the previous symptoms the patient had stomach issues and cramps accompanied by nausea his physician gave Odansetron (Zofran) which relieved the condition. 2 months post vaccination the patient had an anxiety attack due to persistence of symptoms and lack of improvement. The patient was eventually admitted to a hospital approximately 5 months after the vaccine with complaints of pruritus, palpitations, tachycardia, abdominal cramping, chills, nausea/vomiting, feeling hot, depressed level of consciousness and diarrhoea. The patient was later on diagnosed with peripheral neuropathy and interventions were started including physical therapy, treatment with collagen peptides, ice pack, heating pads and weighted blanket. The symptoms were recurring and has not resolved at the time of the report. This case may be confounded by polypharmacy. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed as per medical judgment.  Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2022: Significant Follow-up appended: primary reporter, suspect vaccine and treatment medication details were updated. Event (peripheral neuropathy) was added.; Sender's Comments: This spontaneous case concerns a 48-year-old, male patient with no reported medical history, who experienced the unexpected, serious (hospitalization) event of abdominal pain upper, chills, vomiting, feeling hot, depressed level of consciousness, diarrhoea, nausea along with the unexpected serious (medically significant) neuropathy peripheral, hypersensitivity, insomnia, anxiety, myalgia, arthralgia, fatigue and headache. The patient experienced a series of symptoms over the course of 6 months after receiving the first dose of mRNA1273, the timeline of the serious events reported in this case are as follows : myalgia at 1 day, chills at 2 days, headache 4 days, insomnia 7 days, hypersensitivity at 8 days, arthralgia at 11 days, abdominal pain and nausea at 22 days, fatigue (chronic fatigue) at 1month and anxiety at 2 months post vaccination. The rest of the events occurred at an unknown interval after vaccination of mRNA1273. The patient reported that the symptoms started 1 day post vaccination, he started having muscle soreness on the injection site and spread to become full body muscle pain. The following day still with muscle pain the patient had chills along with loss of appetite and fatigue. 2 days later headache started. About 1 week post vaccination the symptoms still persist now with difficulty in falling asleep. A health care provider suggested that the patient may have systemic allergic reaction to the vaccine and was advised to take Benadryl 25mg, the patient noted that his muscle pain became worse but he did not seek medical care. At around 11 days the patient started having mild joint pain most noticeable at the hips and knees. The patient reported to be still taking medications for pain such as ibuprofen but was later prescribed with gabapentin enacarbil (horizant), pregabalin (lyrica) and tramadol for better management. He was also treated with lorazepam (Ativan) for the difficulty sleeping and anxiety. Along with the previous symptoms the patient had stomach issues and cramps accompanied by nausea his physician gave Odansetron (Zofran) which relieved the condition. 2 months post vaccination the patient had an anxiety attack due to persistence of symptoms and lack of improvement. The patient was eventually admitted to a hospital approximately 5 months after the vaccine with complaints of pruritus, palpitations, tachycardia, abdominal cramping, chills, nausea/vomiting, feeling hot, depressed level of consciousness and diarrhoea. The patient was later on diagnosed with peripheral neuropathy and interventions were started including physical therapy, treatment with collagen peptides, ice pack, heating pads and weighted blanket. The symptoms were recurring and has not resolved at the time of the report. This case may be confounded by polypharmacy. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed as per medical judgment.