chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: HIV antigen negative, Lymphadenopathy, Magnetic resonance imaging abnormal, Myocarditis, SARS-CoV-2 antibody test
Clinical narrative: Pt presented with 2 days of chest pain in conjunction with the expected body aches, chills and fatigue after his second Pfizer vaccine. Found to have elevated troponin and diagnosed with myopericarditis. Treated with NSAIDs, colchicine. Had normal cardiac MRI and CTA coronary. Relatively preserved EF on echo (53%) with no focal wall motion abnormalities.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test positive, Toxicologic test normal, Troponin increased
Clinical narrative: Pt presented with 2 days of chest pain in conjunction with the expected body aches, chills and fatigue after his second Pfizer vaccine. Found to have elevated troponin and diagnosed with myopericarditis. Treated with NSAIDs, colchicine. Had normal cardiac MRI and CTA coronary. Relatively preserved EF on echo (53%) with no focal wall motion abnormalities.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arteriogram coronary normal, Chest pain, Chills, Echocardiogram normal, Ejection fraction normal
Clinical narrative: Pt presented with 2 days of chest pain in conjunction with the expected body aches, chills and fatigue after his second Pfizer vaccine. Found to have elevated troponin and diagnosed with myopericarditis. Treated with NSAIDs, colchicine. Had normal cardiac MRI and CTA coronary. Relatively preserved EF on echo (53%) with no focal wall motion abnormalities.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Magnetic resonance imaging heart, Myocarditis, Pain, Troponin increased
Clinical narrative: Pt presented with 2 days of chest pain in conjunction with the expected body aches, chills and fatigue after his second Pfizer vaccine. Found to have elevated troponin and diagnosed with myopericarditis. Treated with NSAIDs, colchicine. Had normal cardiac MRI and CTA coronary. Relatively preserved EF on echo (53%) with no focal wall motion abnormalities.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Myocarditis
Clinical narrative: Pt presented with 2 days of chest pain in conjunction with the expected body aches, chills and fatigue after his second Pfizer vaccine. Found to have elevated troponin and diagnosed with myopericarditis. Treated with NSAIDs, colchicine. Had normal cardiac MRI and CTA coronary. Relatively preserved EF on echo (53%) with no focal wall motion abnormalities.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: Initially sore arm and sore left breast.  Then over next 2 hours  tingling and numbness on left arm and left side of head and then left leg.  So my Doctor ordered to go to to ER for fear of stroke.  Spent 4 hours in ER and tingling and numbness dissipated and all tests negative.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Breast pain, Computerised tomogram normal, Hypoaesthesia, Pain in extremity
Clinical narrative: Initially sore arm and sore left breast.  Then over next 2 hours  tingling and numbness on left arm and left side of head and then left leg.  So my Doctor ordered to go to to ER for fear of stroke.  Spent 4 hours in ER and tingling and numbness dissipated and all tests negative.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, X-ray normal
Clinical narrative: Initially sore arm and sore left breast.  Then over next 2 hours  tingling and numbness on left arm and left side of head and then left leg.  So my Doctor ordered to go to to ER for fear of stroke.  Spent 4 hours in ER and tingling and numbness dissipated and all tests negative.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Blood iron, Blood test, Chest discomfort, Contusion
Clinical narrative: Received vaccine on 4/7/2021. Starting next day-intense all over body itching...increased a few days. Skin flushes-arms, stomach, chest, lower back. Eye twitches. Pressure under left rib cage. Unexplained bruising-legs and arms. Inflamed veins..arms, legs, mouth. Vasculitis? Increased anxiety. Waking up in cold sweats. 2 weeks post vaccine-tongue started swelling up and develope pasty white coating, mouth lesions and blisters. Increased inflamed veins in mouth-Ongoing.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyskinesia, Feeling hot, Hypoaesthesia oral, Inflammation, Muscle twitching
Clinical narrative: Received vaccine on 4/7/2021. Starting next day-intense all over body itching...increased a few days. Skin flushes-arms, stomach, chest, lower back. Eye twitches. Pressure under left rib cage. Unexplained bruising-legs and arms. Inflamed veins..arms, legs, mouth. Vasculitis? Increased anxiety. Waking up in cold sweats. 2 weeks post vaccine-tongue started swelling up and develope pasty white coating, mouth lesions and blisters. Increased inflamed veins in mouth-Ongoing.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oral candidiasis, Oral discomfort, Pain in extremity, Platelet count, Pruritus
Clinical narrative: Received vaccine on 4/7/2021. Starting next day-intense all over body itching...increased a few days. Skin flushes-arms, stomach, chest, lower back. Eye twitches. Pressure under left rib cage. Unexplained bruising-legs and arms. Inflamed veins..arms, legs, mouth. Vasculitis? Increased anxiety. Waking up in cold sweats. 2 weeks post vaccine-tongue started swelling up and develope pasty white coating, mouth lesions and blisters. Increased inflamed veins in mouth-Ongoing.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, SARS-CoV-2 test, Skin burning sensation, Swollen tongue, Taste disorder
Clinical narrative: Received vaccine on 4/7/2021. Starting next day-intense all over body itching...increased a few days. Skin flushes-arms, stomach, chest, lower back. Eye twitches. Pressure under left rib cage. Unexplained bruising-legs and arms. Inflamed veins..arms, legs, mouth. Vasculitis? Increased anxiety. Waking up in cold sweats. 2 weeks post vaccine-tongue started swelling up and develope pasty white coating, mouth lesions and blisters. Increased inflamed veins in mouth-Ongoing.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: White blood cell count
Clinical narrative: Received vaccine on 4/7/2021. Starting next day-intense all over body itching...increased a few days. Skin flushes-arms, stomach, chest, lower back. Eye twitches. Pressure under left rib cage. Unexplained bruising-legs and arms. Inflamed veins..arms, legs, mouth. Vasculitis? Increased anxiety. Waking up in cold sweats. 2 weeks post vaccine-tongue started swelling up and develope pasty white coating, mouth lesions and blisters. Increased inflamed veins in mouth-Ongoing.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Blepharospasm, Cold sweat, Contusion, Discomfort
Clinical narrative: Received vaccine on 4/7/2021. Starting next day-intense all over body itching...increased a few days. Skin flushes-arms, stomach, chest, lower back. Eye twitches. Pressure under left rib cage. Unexplained bruising-legs and arms. Inflamed veins..arms, legs, mouth. Vasculitis? Increased anxiety. Waking up in cold sweats. 2 weeks post vaccine-tongue started swelling up and develope pasty white coating, mouth lesions and blisters. Increased inflamed veins in mouth-Ongoing.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Full blood count normal, Mouth ulceration, Platelet count, Pruritus
Clinical narrative: Received vaccine on 4/7/2021. Starting next day-intense all over body itching...increased a few days. Skin flushes-arms, stomach, chest, lower back. Eye twitches. Pressure under left rib cage. Unexplained bruising-legs and arms. Inflamed veins..arms, legs, mouth. Vasculitis? Increased anxiety. Waking up in cold sweats. 2 weeks post vaccine-tongue started swelling up and develope pasty white coating, mouth lesions and blisters. Increased inflamed veins in mouth-Ongoing.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Swollen tongue, Tongue blistering, Tongue coated, Vasculitis
Clinical narrative: Received vaccine on 4/7/2021. Starting next day-intense all over body itching...increased a few days. Skin flushes-arms, stomach, chest, lower back. Eye twitches. Pressure under left rib cage. Unexplained bruising-legs and arms. Inflamed veins..arms, legs, mouth. Vasculitis? Increased anxiety. Waking up in cold sweats. 2 weeks post vaccine-tongue started swelling up and develope pasty white coating, mouth lesions and blisters. Increased inflamed veins in mouth-Ongoing.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: First 48 hours, fever and chills on and off. Starting after the first 24 hours, I had a headache on and off since. I have had fever ever since the  shot  and the highest it got has been 100.0 - on the 29th - 02:41P MST . On May 12, I went to see my Dr. and she prescribed an antibiotic for sinus infection- Amox-clav - I took that for 5 days as directed. She encouraged me to contact her after 5 days for follow up. May 17, I called her back and told her I didn't feel any different and she changed me to Doxycycline and she had  Methylprednisolone- and I started both of those on the evening of May 17. I continue those until Wednesday evening. But I noticed bright redness on my face in the morning, and itching and hoarseness in my voice and I called her Thursday morning and she advised me to stop taking both medications the doxycycline and the Methylprednisolone. She advised I go to   Urgent care center - . I went on May 23, at 09:00 MST and I saw a physician assistant there -- and she examined me and I told her about my fever and headaches. She didn't know what to make of it - said she couldn't run a blood culture at the time because I had taken the steroids. She did still see signs of sinus infection. She gave me Cefdinir antibiotic and I'm still on that until this coming Sunday. I am still having fever and headaches - not as severe (as far as the headaches). My temperature is relatively low in the morning - starts out 98.3 and goes up to above 99 every day. It usually runs at 94.5 (my normal body temperature). That's what it was when I came home and tested it  right after the vaccine when I started documenting for v-safe. I still haven't had a normal body temperature for me since April 28.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Chills, Headache, Pyrexia, Sinusitis
Clinical narrative: First 48 hours, fever and chills on and off. Starting after the first 24 hours, I had a headache on and off since. I have had fever ever since the  shot  and the highest it got has been 100.0 - on the 29th - 02:41P MST . On May 12, I went to see my Dr. and she prescribed an antibiotic for sinus infection- Amox-clav - I took that for 5 days as directed. She encouraged me to contact her after 5 days for follow up. May 17, I called her back and told her I didn't feel any different and she changed me to Doxycycline and she had  Methylprednisolone- and I started both of those on the evening of May 17. I continue those until Wednesday evening. But I noticed bright redness on my face in the morning, and itching and hoarseness in my voice and I called her Thursday morning and she advised me to stop taking both medications the doxycycline and the Methylprednisolone. She advised I go to   Urgent care center - . I went on May 23, at 09:00 MST and I saw a physician assistant there -- and she examined me and I told her about my fever and headaches. She didn't know what to make of it - said she couldn't run a blood culture at the time because I had taken the steroids. She did still see signs of sinus infection. She gave me Cefdinir antibiotic and I'm still on that until this coming Sunday. I am still having fever and headaches - not as severe (as far as the headaches). My temperature is relatively low in the morning - starts out 98.3 and goes up to above 99 every day. It usually runs at 94.5 (my normal body temperature). That's what it was when I came home and tested it  right after the vaccine when I started documenting for v-safe. I still haven't had a normal body temperature for me since April 28.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Injection site bruising, Injection site pain, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: swelling in left arm, severe pain in neck, shoulder, and arm upper area. Not sure if its becausethe shot was given very low in the shoulder.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Neck pain, Pain in extremity, Peripheral swelling, Product administered at inappropriate site
Clinical narrative: swelling in left arm, severe pain in neck, shoulder, and arm upper area. Not sure if its becausethe shot was given very low in the shoulder.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Joint injury, Paraesthesia
Clinical narrative: Error: Wrong Route (SC, IM, etc.)
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Error: Wrong Route (SC, IM, etc.)
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Injection site pain
Clinical narrative: Unspecified lot, unspecified arm. Pain, swelling. Per patient: MELAS patient. First Shot Pfizer.    Pain in arm and chest.  Unilateral numness of face/tongue and unilateral swelling of lips.  One shot benadryl.  Improved swelling.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Hypoaesthesia, Hypoaesthesia oral, Lip swelling, Pain in extremity
Clinical narrative: Unspecified lot, unspecified arm. Pain, swelling. Per patient: MELAS patient. First Shot Pfizer.    Pain in arm and chest.  Unilateral numness of face/tongue and unilateral swelling of lips.  One shot benadryl.  Improved swelling.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure, Cerebrovascular accident, Death, Hypercapnia, Hypertensive urgency
Clinical narrative: Patient was hospitalized and died within 60 days of receiving a COVID vaccine series
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoxia
Clinical narrative: Patient was hospitalized and died within 60 days of receiving a COVID vaccine series
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Patient was hospitalized and died within 60 days of receiving a COVID vaccine series
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abnormal dreams, Amnesia, Confusional state, Dreamy state, Feeling abnormal
Clinical narrative: Confusion, memory loss, fatigue, acting abnormally
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hallucination, Nightmare
Clinical narrative: Confusion, memory loss, fatigue, acting abnormally
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abnormal behaviour, Alcohol test, Ammonia, Amnesia, Analgesic drug level
Clinical narrative: Confusion, memory loss, fatigue, acting abnormally
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood creatine phosphokinase, Blood glucose, Blood magnesium, Computerised tomogram head, Confusional state
Clinical narrative: Confusion, memory loss, fatigue, acting abnormally
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug screen, Fatigue, Full blood count, Magnetic resonance imaging head, Metabolic function test
Clinical narrative: Confusion, memory loss, fatigue, acting abnormally
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Urine analysis
Clinical narrative: Confusion, memory loss, fatigue, acting abnormally
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: NURSE GAVE A .6CC INJECTION AND IT SHOULD HAVE BEEN .3CC
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Saline diluent used a second time for a second pfizer vial . No adverse events reported
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular, Vaginal discharge
Clinical narrative: Moderna COVID?19 Vaccine EUA  Change in color and thickness of Vaginal discharge  Period started 2 weeks early, very heavy
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Saline diluent used a second time for a second pfizer vial . No adverse events reported
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: NURSE GAVE A .6CC INJECTION INSTEAD OF .3CC
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest X-ray normal, Chest pain, Chills, Fatigue
Clinical narrative: Aching intermittent Left-sided CP x 2-3 hours, started while sitting today, radiates to Lt shoulder, deep breath makes worse; J&J COVAX yesterday.23 yo m presents with chest pain that radiates to lt shoulder, chills last night. J&J COVAX yesterday
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: Aching intermittent Left-sided CP x 2-3 hours, started while sitting today, radiates to Lt shoulder, deep breath makes worse; J&J COVAX yesterday.23 yo m presents with chest pain that radiates to lt shoulder, chills last night. J&J COVAX yesterday
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: NURSE GAVE .6CC INJECTION INSTEAD OF .3CC
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: PT states getting J/J vaccine on tuesday, states lightheadedness and nausea today with headache and fever yesterday. 20-year-old male who reported to the emergency room with symptoms consistent with resolving side effects of coronavirus vaccine and/or mild dehydration.  Patient's nausea resolved after 4 mg of Zofran and he subjectively felt better after 1 L of normal saline hydration.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Dyspnoea, Raynaud's phenomenon, Tremor
Clinical narrative: I started having hives 10 days after the shot - about midnight.  It has been spreading around my body, changing locations, but has now lasted for almost 48 hours.  Last night it was around my ears, eyes and mouth, the first night around my bra and panty lines.  Today it is affecting mostly my arms and hands. I'm not having any difficulty breathing, but I have noticed that my Raynauds has worsened since I got the shot.  It was very bad of course when I had the chills and shakes 12 hours after being vaccinated. I am taking Benadryl and my doctor said she could prescribe me zyrtech so that I can work.  I can't wear any clothes because any contact seems to make the hives worse.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: I started having hives 10 days after the shot - about midnight.  It has been spreading around my body, changing locations, but has now lasted for almost 48 hours.  Last night it was around my ears, eyes and mouth, the first night around my bra and panty lines.  Today it is affecting mostly my arms and hands. I'm not having any difficulty breathing, but I have noticed that my Raynauds has worsened since I got the shot.  It was very bad of course when I had the chills and shakes 12 hours after being vaccinated. I am taking Benadryl and my doctor said she could prescribe me zyrtech so that I can work.  I can't wear any clothes because any contact seems to make the hives worse.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Bacterial infection, Dizziness, Headache, Intestinal obstruction, Nausea
Clinical narrative: PT states getting the COVID vaccine moderna x2 days ago with dizziness, nausea, and light headedness starting yesterday night. 19-year-old female comes to emergency room for 48 hours of nausea, vomiting and headache.  Her examination was not concerning for bowel obstruction or serious underlying bacterial infection.  She is subjectively improved after 2 L of normal saline hydration and Zofran 4 mg.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: PT states getting the COVID vaccine moderna x2 days ago with dizziness, nausea, and light headedness starting yesterday night. 19-year-old female comes to emergency room for 48 hours of nausea, vomiting and headache.  Her examination was not concerning for bowel obstruction or serious underlying bacterial infection.  She is subjectively improved after 2 L of normal saline hydration and Zofran 4 mg.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Depressed mood, Depression, Fatigue, Nausea
Clinical narrative: Night of receiving 2nd dose of vaccine, 5/11/21, awoke in the middle of the night with nausea, extreme restlessness, anxiety, and had minimal, fitful sleep with nightmares.  Experienced extreme fatigue, low mood, notable body aching and pains, and slight nausea the following day, 5/12/21, and continuing intense dreaming that evening. Experienced abnormally intense dreams every night for at least one week following the night of receiving 2nd dose of the vaccine on 5/11/21. Experienced increased feelings of depression and anxiety every day for at least two weeks following the day of receiving 2nd dose of vaccine (continuing up until now, current day of 5/26/21).  No treatment obtained for any adverse effects experienced, other than taking Ibuprofen to relieve aches and pains the first two days after receiving vaccine dose.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Nightmare, Pain, Restlessness, Sleep disorder
Clinical narrative: Night of receiving 2nd dose of vaccine, 5/11/21, awoke in the middle of the night with nausea, extreme restlessness, anxiety, and had minimal, fitful sleep with nightmares.  Experienced extreme fatigue, low mood, notable body aching and pains, and slight nausea the following day, 5/12/21, and continuing intense dreaming that evening. Experienced abnormally intense dreams every night for at least one week following the night of receiving 2nd dose of the vaccine on 5/11/21. Experienced increased feelings of depression and anxiety every day for at least two weeks following the day of receiving 2nd dose of vaccine (continuing up until now, current day of 5/26/21).  No treatment obtained for any adverse effects experienced, other than taking Ibuprofen to relieve aches and pains the first two days after receiving vaccine dose.
Age: 38.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Urticaria
Clinical narrative: itchiness and hives
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Chest discomfort, Chills, Diarrhoea, Eye pain
Clinical narrative: Chills, pain behind eyes, fever, body aches, nausea, vomiting, diarrhea, chest restriction, bloating, fatigue
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Chills, pain behind eyes, fever, body aches, nausea, vomiting, diarrhea, chest restriction, bloating, fatigue
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Atrial flutter, Atrioventricular block, Cardiac stress test, Echocardiogram, Heart rate irregular
Clinical narrative: March 22nd: ~6pm: Received 2nd dose of Pfizer Vax. March 23rd: ~12am:  Started to notice irregular heartbeats.  Used iWatch ECG feature and confirmed irregular heart beats. March 24th: 11pm: Went to urgent care for 12 lead EKG.  EKG showed signs of PAC and referred me to see cardiologist for further follow-up March 25-April 13th - Irregular heart beat episodes can last from 15 min - 12 hours.  Period between episodes varies from few hours to several days.  April 14: Met with healthcare provider at healthcare facility.  He prescribed an event monitor, stress test, and echocardiogram April 21: Started wearing heart monitor (ZioXT).  During 2 week wear period, experienced several episodes.  Monitor results showed 1st degree AV Block, SVT, Atrial Flutter (<1% burden), 2nd degree AV Block - Mobitz I May 19: Return to healthcare facility for stress test, and echocardiogram.  During stress test, experienced SVT. doctor referred me to another doctor for further evaluation.  Doctor recommended cardiac MRI - scheduled for Jun 7, 2021
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Supraventricular extrasystoles, Supraventricular tachycardia
Clinical narrative: March 22nd: ~6pm: Received 2nd dose of Pfizer Vax. March 23rd: ~12am:  Started to notice irregular heartbeats.  Used iWatch ECG feature and confirmed irregular heart beats. March 24th: 11pm: Went to urgent care for 12 lead EKG.  EKG showed signs of PAC and referred me to see cardiologist for further follow-up March 25-April 13th - Irregular heart beat episodes can last from 15 min - 12 hours.  Period between episodes varies from few hours to several days.  April 14: Met with healthcare provider at healthcare facility.  He prescribed an event monitor, stress test, and echocardiogram April 21: Started wearing heart monitor (ZioXT).  During 2 week wear period, experienced several episodes.  Monitor results showed 1st degree AV Block, SVT, Atrial Flutter (<1% burden), 2nd degree AV Block - Mobitz I May 19: Return to healthcare facility for stress test, and echocardiogram.  During stress test, experienced SVT. doctor referred me to another doctor for further evaluation.  Doctor recommended cardiac MRI - scheduled for Jun 7, 2021
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Hypomenorrhoea
Clinical narrative: My first done was April 27 and my second dose was May 25. Both times I was on my period. However, my current period came much lighter the previous period.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Antineutrophil cytoplasmic antibody negative, Cardiac tamponade, Chest X-ray abnormal, Echocardiogram abnormal, Electrocardiogram abnormal
Clinical narrative: eosinophilia, cardiac tamponade/ pericarditis. Pericardial fluid was eosinophilic. One month later, he developed patchy pulmonary infiltrates.but biopsy was not obtained and ANCA was negative.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Eosinophilia, Lung infiltration, Pericardial drainage, Pericardial effusion, Pericarditis
Clinical narrative: eosinophilia, cardiac tamponade/ pericarditis. Pericardial fluid was eosinophilic. One month later, he developed patchy pulmonary infiltrates.but biopsy was not obtained and ANCA was negative.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Right ventricular diastolic collapse
Clinical narrative: eosinophilia, cardiac tamponade/ pericarditis. Pericardial fluid was eosinophilic. One month later, he developed patchy pulmonary infiltrates.but biopsy was not obtained and ANCA was negative.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Thrombosis
Clinical narrative: Prolonged menstrual bleeding, unstoppable with blood clods.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Varicella zoster virus infection
Clinical narrative: Shingles. Herpes Zoster.  Reactivation of varicella-zoster virus along  C8 dermitome left side.   Responded to valacyclovir HCL 1 gram tablets 3x daily for 7 days.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle contractions involuntary, Pain
Clinical narrative: Mild deltoid pain with arm movement and muscle contraction persisting to more than 5 weeks post-vaccination.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Feeling like passing out. Evaluated by EMS-Refusal to transport.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Breaking out in hives a little Every evening since getting the 2nd shot
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, Chiropractic, Fatigue, Headache
Clinical narrative: After shot injection my left arm was extremely sore then soon after that my left arm including my armpit and side of left breast and my left arm from armpit to elbow became extremely painful to move as if it was  muscle strain. Any kind of movement is painful some days are mild and other days are severe. I have gone to seek chiropractic treatment with some relief but here I am 6 weeks later and still having same pain. I use topical pain relief gels and take ibuprofen. .. the next day after injection I did become extremely tired for 2 days but some mild to mod headaches but those have since gone away. I still dont know what else to do with the on going arm pain.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle strain, Pain, Pain in extremity
Clinical narrative: After shot injection my left arm was extremely sore then soon after that my left arm including my armpit and side of left breast and my left arm from armpit to elbow became extremely painful to move as if it was  muscle strain. Any kind of movement is painful some days are mild and other days are severe. I have gone to seek chiropractic treatment with some relief but here I am 6 weeks later and still having same pain. I use topical pain relief gels and take ibuprofen. .. the next day after injection I did become extremely tired for 2 days but some mild to mod headaches but those have since gone away. I still dont know what else to do with the on going arm pain.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram cerebral abnormal, Aphasia, Arteriogram carotid, Basilar artery occlusion, Cerebrovascular accident
Clinical narrative: Acute basilar artery occlusion resulting in CVA: Patient presented as a stroke alert with rapid onset of altered mental status with nonsensical speech, followed by aphasia. Initial NIH of 20. No history of stroke. No history of COVID.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head abnormal, Disorganised speech, Magnetic resonance imaging head, Mental status changes, NIH stroke scale score increased
Clinical narrative: Acute basilar artery occlusion resulting in CVA: Patient presented as a stroke alert with rapid onset of altered mental status with nonsensical speech, followed by aphasia. Initial NIH of 20. No history of stroke. No history of COVID.
Age: 65.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: Headache, joint pain, throat hurt, chills, and fatigue for 2 days.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: About 10 to 15 minutes after the injection, I had a slight pressure on the right side of my neck that went up to  my right jaw, and up in front of my right ear and up to my cheekbone.   That pressure lasted the rest of that day.  When I went to bed around 10:30 pm, I took one 325mg tylenol.  In the morning, the pressure was still there but lessened.  It continued on and off the second day but by nighttime was mostly gone.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness started after 9-10 days of receiving 2nd shot which is not going away till today. PL help what should I do to cure it. Thank you.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Pain, Pain in extremity
Clinical narrative: Left arm pain, a light throbbing chest pain near arm pit throughout the 2nd and 3rd day after shot.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Headache, Hot flush, Hyperhidrosis
Clinical narrative: chills, hot flashes that have persisted for more than 2 days, extremely hot/sweaty, constant headache/soreness at injection site.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: chills, hot flashes that have persisted for more than 2 days, extremely hot/sweaty, constant headache/soreness at injection site.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Stillbirth
Clinical narrative: Stillbirth at 39 weeks and 3 days
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein increased, Cerebral venous sinus thrombosis, Cerebral venous thrombosis, Computerised tomogram head abnormal, Fibrin D dimer increased
Clinical narrative: Headache onset 3-4 days after vaccine on 4/27/21. Subsequently developed visual changes (right homonymous hemianopsia/visual field cut) on 5/23/21 and presented to ED, diagnosed with cerebral venous thrombosis (left transverse, sigmoid and internal jugular thrombosis). On initial labs also had thrombocytopenia and mild leukocytosis.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haemoglobin normal, Headache, Hemianopia homonymous, Heparin-induced thrombocytopenia, Jugular vein thrombosis
Clinical narrative: Headache onset 3-4 days after vaccine on 4/27/21. Subsequently developed visual changes (right homonymous hemianopsia/visual field cut) on 5/23/21 and presented to ED, diagnosed with cerebral venous thrombosis (left transverse, sigmoid and internal jugular thrombosis). On initial labs also had thrombocytopenia and mild leukocytosis.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Leukocytosis, Magnetic resonance imaging, Magnetic resonance imaging head abnormal, Platelet count decreased, Thrombocytopenia
Clinical narrative: Headache onset 3-4 days after vaccine on 4/27/21. Subsequently developed visual changes (right homonymous hemianopsia/visual field cut) on 5/23/21 and presented to ED, diagnosed with cerebral venous thrombosis (left transverse, sigmoid and internal jugular thrombosis). On initial labs also had thrombocytopenia and mild leukocytosis.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Transverse sinus thrombosis, Visual field defect, Visual impairment, White blood cell count normal
Clinical narrative: Headache onset 3-4 days after vaccine on 4/27/21. Subsequently developed visual changes (right homonymous hemianopsia/visual field cut) on 5/23/21 and presented to ED, diagnosed with cerebral venous thrombosis (left transverse, sigmoid and internal jugular thrombosis). On initial labs also had thrombocytopenia and mild leukocytosis.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Lymphadenopathy
Clinical narrative: 7 days so far of swollen left armpit gland 7 days so far of morning or evening headache General fogginess
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Echocardiogram abnormal, Magnetic resonance imaging, Myocarditis, Palpitations
Clinical narrative: Heart beat racing . Severe palpitations. Mri done after several visits to be told i had Myocardiatis.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Positron emission tomogram
Clinical narrative: Heart beat racing . Severe palpitations. Mri done after several visits to be told i had Myocardiatis.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood creatine phosphokinase MB normal, C-reactive protein normal, Cardiac imaging procedure abnormal, Dyspnoea exertional, Echocardiogram
Clinical narrative: Heart beat racing . Severe palpitations. Mri done after several visits to be told i had Myocardiatis.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram abnormal, Ejection fraction decreased, Electrocardiogram QRS complex abnormal, Electrocardiogram QT prolonged, Electrocardiogram ST segment abnormal
Clinical narrative: Heart beat racing . Severe palpitations. Mri done after several visits to be told i had Myocardiatis.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Left atrial enlargement, Left ventricular enlargement, Lethargy, Magnetic resonance imaging heart
Clinical narrative: Heart beat racing . Severe palpitations. Mri done after several visits to be told i had Myocardiatis.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mitral valve incompetence, Mitral valve prolapse, Myocardial oedema, Myocarditis, N-terminal prohormone brain natriuretic peptide increased
Clinical narrative: Heart beat racing . Severe palpitations. Mri done after several visits to be told i had Myocardiatis.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Pericardial effusion, Red blood cell sedimentation rate normal, Right ventricular ejection fraction decreased, Sinus bradycardia
Clinical narrative: Heart beat racing . Severe palpitations. Mri done after several visits to be told i had Myocardiatis.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Troponin normal, Ventricular extrasystoles, Ventricular hypokinesia
Clinical narrative: Heart beat racing . Severe palpitations. Mri done after several visits to be told i had Myocardiatis.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Chills, Echocardiogram normal, Electrocardiogram normal, Fatigue
Clinical narrative: On 5/7, she developed fatigue, chills, palpitations. She felt unwell and presented to the ED on  5/12.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer increased, Malaise, Palpitations, Troponin increased
Clinical narrative: On 5/7, she developed fatigue, chills, palpitations. She felt unwell and presented to the ED on  5/12.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Diagnosed shingles. No prior health issues or immune compromising conditions.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Oedema, Palpitations
Clinical narrative: PITTING EDEMA BLE, HEART PALPITATION
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Insomnia, Tinnitus
Clinical narrative: My ears haven?t stopped ringing since I got the vaccine. It?s the first noise I hear in the morning it?s the last noise I hear before I fall asleep and every waking moment between, it?s maddening.  I can?t take it.  It?s anxiety causing and so disruptive I can barely concentrate or sleep, it?s louder than every ambient noise.  While the vac may or perhaps not be the cause, getting the J&J vaccine is the only thing in this timeline that I can pin point.  There have been no other changes in my life that would indicate it came from anywhere else.  What can I do to make it stop.  I can?t imagine living the next 40 years of my life this way, it?s unbearable.  Had I known this may have been a side effect I never would have done it. I lived through the peak of Covid but I don?t know how I?ll live productively with  this plaguing ringing in my ears.  Please suggest a remedy, if you know of one.  Signed, terribly regretful.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Dizziness, Insomnia, Pain in extremity, Tinnitus
Clinical narrative: My ears haven?t stopped ringing since I got the vaccine. It?s the first noise I hear in the morning it?s the last noise I hear before I fall asleep and every waking moment between, it?s maddening.  I can?t take it.  It?s anxiety causing and so disruptive I can barely concentrate or sleep, it?s louder than every ambient noise.  While the vac may or perhaps not be the cause, getting the J&J vaccine is the only thing in this timeline that I can pin point.  There have been no other changes in my life that would indicate it came from anywhere else.  What can I do to make it stop.  I can?t imagine living the next 40 years of my life this way, it?s unbearable.  Had I known this may have been a side effect I never would have done it. I lived through the peak of Covid but I don?t know how I?ll live productively with  this plaguing ringing in my ears.  Please suggest a remedy, if you know of one.  Signed, terribly regretful.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Gait disturbance, Headache
Clinical narrative: Woke in a.m. with heavy pressure pain mid chest and struggling to breathe, massive headache, could barely walk.  Got up and thought I'd better sleep somehow so tried to find best position to allow me to breathe with less pain. Up/down several times, finally got to sleep.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Heart rate increased, Nausea, Pyrexia
Clinical narrative: Extreme Chest pain in heart region, 103 degree fever, extreme chills, nausea, and high heart beat
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vitiligo
Clinical narrative: Vitiligo -auto immune issue (never had it before)
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Polymenorrhoea, Pregnancy test negative
Clinical narrative: Had a very early menstruation within 10 days of the previous menstruation when period has been regular and tracked for years using an app. In additon it was a very heavy cycle and very painful. Now I've not had menstration for 40 days. After multiple at home pregnancy tests. I went to a physician and was tested and results are negative for pregnancy. She stated she is seeing multiple patients who are having multiple periods early or no periods and has asked me to report my experience to CDC.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: About 1 day after receiving  my second dose of the moderne shot, my left arm where I got the shot started to get warm, itchy, swollen and red. 7 days after receiving my first dose of moderna I had the same adverse reaction.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Fatigue, Pain, Pain in extremity, Pyrexia
Clinical narrative: High fever 105. on and off. fever being treated with Tylenol and Motrin rotation. Fever does respond to the tylenol for 3 hours. Patient does have a history of high fevers when sick and has experienced a febrile seizure in the past.  Patient is experiencing fatigue. body aches (Soreness in both arms as expected).  Since the fever has been under control there has been no need for a ER visit at this time. However if her fevers continue over the next 24 hours I will follow-up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Hypersomnia, Loss of personal independence in daily activities
Clinical narrative: My first shot came with full body hives, sweats, and I slept for three days straight. Felt normal in a little over a week. My second shot, I work up the next morning with one of the worst headaches I've ever had. I started to develop a fever. 101.5. It spiked at 102. The fever was off and on for three days. I couldn't stop sleeping. I could only stay awake for a couple of hours at a time. That lasted for four days. Now today marks the two week anniversary and I can only stay awake for six or seven hours at a time, then I'll sleep for seven or eight, and repeat. I am SO tired I can barely function. I talked to a doctor friend who suggested I file a report here. I don't have health insurance and can't go to the doctor.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urticaria
Clinical narrative: My first shot came with full body hives, sweats, and I slept for three days straight. Felt normal in a little over a week. My second shot, I work up the next morning with one of the worst headaches I've ever had. I started to develop a fever. 101.5. It spiked at 102. The fever was off and on for three days. I couldn't stop sleeping. I could only stay awake for a couple of hours at a time. That lasted for four days. Now today marks the two week anniversary and I can only stay awake for six or seven hours at a time, then I'll sleep for seven or eight, and repeat. I am SO tired I can barely function. I talked to a doctor friend who suggested I file a report here. I don't have health insurance and can't go to the doctor.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Drug resistance, Vertigo
Clinical narrative: I began have episodes of severe vertigo and dizziness 4 days post vaccination. They are unresponsive to typical medications used for vertigo.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Chest pain, Chills
Clinical narrative: Fever, chills, chest pain, upper abdominal pain, aches, dizziness, weakness,  joint pain, fatigue
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Pain, Pyrexia
Clinical narrative: Fever, chills, chest pain, upper abdominal pain, aches, dizziness, weakness,  joint pain, fatigue
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever, myalgia, fatigue
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Ear discomfort, Fatigue, Headache, Hypoacusis
Clinical narrative: Side effects started about 8 hours after injection.  Included fever of 101.9, sore right arm, achy and very tired.  Fell asleep about 8pm on 3/29/21 with the TV on.  Was laying on my left side.  Woke up around 11pm and could not hear the TV very well.  I sat up and realized I could now hear fine.  Covered my left ear and again could not hear very well.  Because I felt terrible I just went back to sleep.  The next day I slept almost the entire day, not really eating or drinking anything.  On the 31st I noticed that I had a high-pitched hum in my right ear and a feeling of a clogged ear. I had a terrible headache that went away after I ate and drank something.  I thought the ear issues  were just related to lymph nodes being impacted by the vaccine.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Malaise, Pain, Pain in extremity, Pyrexia
Clinical narrative: Side effects started about 8 hours after injection.  Included fever of 101.9, sore right arm, achy and very tired.  Fell asleep about 8pm on 3/29/21 with the TV on.  Was laying on my left side.  Woke up around 11pm and could not hear the TV very well.  I sat up and realized I could now hear fine.  Covered my left ear and again could not hear very well.  Because I felt terrible I just went back to sleep.  The next day I slept almost the entire day, not really eating or drinking anything.  On the 31st I noticed that I had a high-pitched hum in my right ear and a feeling of a clogged ear. I had a terrible headache that went away after I ate and drank something.  I thought the ear issues  were just related to lymph nodes being impacted by the vaccine.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Side effects started about 8 hours after injection.  Included fever of 101.9, sore right arm, achy and very tired.  Fell asleep about 8pm on 3/29/21 with the TV on.  Was laying on my left side.  Woke up around 11pm and could not hear the TV very well.  I sat up and realized I could now hear fine.  Covered my left ear and again could not hear very well.  Because I felt terrible I just went back to sleep.  The next day I slept almost the entire day, not really eating or drinking anything.  On the 31st I noticed that I had a high-pitched hum in my right ear and a feeling of a clogged ear. I had a terrible headache that went away after I ate and drank something.  I thought the ear issues  were just related to lymph nodes being impacted by the vaccine.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Headache, Nausea, Pyrexia
Clinical narrative: Currently can?t get warm with body chills/shakes but probably have a fever. Headache and nausea. Took 2 ibuprofen 200mg/ea at 0130
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Currently can?t get warm with body chills/shakes but probably have a fever. Headache and nausea. Took 2 ibuprofen 200mg/ea at 0130
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: No additional AE; expired dose of VAQTA administered to a patient; Date of excursion: 20-JAN-2021; Temperature 46.2F; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.   On 05-MAY-2021, the patient was vaccinated with an expired and improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 50U/1ml, lot # reported as T014590, with expiration date 15-APR-2021 (both confirmed to be valid), 1 dose form for prophylaxis. The temperature excursion was 46.2 degrees Fahrenheit (F) for 10 minutes which occurred on 20-JAN-2021. There were no previous excursions reported. The digital data logger was not involved. No additional adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T014590; expirationdate: 15-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability