chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Balance disorder, Burning sensation, Discomfort, Eyelid irritation
Clinical narrative: Headache and body aches were mild. Then, began to have burning in eyelids and down side of nose started and continues until now. It decreased after dermatologist perscribed medication. On 3/13 went to hospital with severe chest pain. They determined it was muscular-sceletal. While in the hospital and to this day has burning in bottoms of feet. Has weakness and numbness in both legs and feet. The weakness decreases ability for activity- very uncomforatable and making her unsteady when up. She also has some weakness in her arms.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Muscular weakness, Musculoskeletal chest pain, Pain
Clinical narrative: Headache and body aches were mild. Then, began to have burning in eyelids and down side of nose started and continues until now. It decreased after dermatologist perscribed medication. On 3/13 went to hospital with severe chest pain. They determined it was muscular-sceletal. While in the hospital and to this day has burning in bottoms of feet. Has weakness and numbness in both legs and feet. The weakness decreases ability for activity- very uncomforatable and making her unsteady when up. She also has some weakness in her arms.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Muscle twitching, Syncope
Clinical narrative: Sitting down on bleachers immediatly after receiving COVID vaccine - started feeling lightheaded and had a witnessed syncopal episode.  Patient hit his head on the back of the bleacher and passed out for a few seconds. Reports twitching movements. Reportedly does have a history of passing out with injections and piercings in the past.  He had not had anything to eat or drink that day.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Computerised tomogram, Dizziness, Electrocardiogram normal, Ophthalmological examination normal
Clinical narrative: Dizziness, Vision got significantly worst out of nowhere, can't focus, Balance issues, Seems like vertigo, room spinning when laying down.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo, Visual impairment
Clinical narrative: Dizziness, Vision got significantly worst out of nowhere, can't focus, Balance issues, Seems like vertigo, room spinning when laying down.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Influenza virus test negative, Oropharyngeal pain, Rash, SARS-CoV-2 test negative
Clinical narrative: Sore throat starting the next day possibly connected to the high pollen count rash no itching just warm and red skin
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Streptococcus test negative
Clinical narrative: Sore throat starting the next day possibly connected to the high pollen count rash no itching just warm and red skin
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Full blood count normal, Headache, Hepatic enzyme, Malaise
Clinical narrative: After receiving my second dose, i started to feel very sick, by the second day after the vaccination, I had a severe headache, my eyes couldn't focus i was nauseous and i was vomiting, sever upper body pains,  it was the worst headache I have ever had in my life, my husband took me to the emergency room yesterday and i was there all day, I had a neurological exam, blood work and chest x-ray, everything came back negative, i was told my the attending physician that it was the side effects of the second dose of the Pfizer Vaccine.  I was given Motrin 600mg and  Metoclopramide via intravenous, several hours later, i was feeling a bit better and i was released from the hospital by 4:30pm.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neurological examination normal, Pain, Vision blurred, Vomiting
Clinical narrative: After receiving my second dose, i started to feel very sick, by the second day after the vaccination, I had a severe headache, my eyes couldn't focus i was nauseous and i was vomiting, sever upper body pains,  it was the worst headache I have ever had in my life, my husband took me to the emergency room yesterday and i was there all day, I had a neurological exam, blood work and chest x-ray, everything came back negative, i was told my the attending physician that it was the side effects of the second dose of the Pfizer Vaccine.  I was given Motrin 600mg and  Metoclopramide via intravenous, several hours later, i was feeling a bit better and i was released from the hospital by 4:30pm.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Mass, Rash erythematous
Clinical narrative: red rash around COVID moderna injection site and a hard lump appeared a week and a half after injection.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Computerised tomogram head, Deafness unilateral, Electrocardiogram, Magnetic resonance imaging head
Clinical narrative: Loss of hearing in right ear on 3/25/21, ringing in ear on 3/25/21, Vertigo on 3/26/21
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vertigo
Clinical narrative: Loss of hearing in right ear on 3/25/21, ringing in ear on 3/25/21, Vertigo on 3/26/21
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Idiopathic intracranial hypertension
Clinical narrative: Pain at injection site, severe stomach pain and dieherria 12 hours after injection for about one hour
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Headache, Pain
Clinical narrative: Vaccinated with Pfizer COVID vaccine on 12/26/2020.  On 1/6/2021 developed body aches, cough, and headache.   Positive for COVID.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure decreased, Dizziness
Clinical narrative: Patient stated she was dizzy and remained in bed for 5 days following vaccination. She said her blood pressure dropped from 140 to 100. She also experienced weakness.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Lymphadenopathy, Tinnitus
Clinical narrative: March 10 developed large lymphnode with pain under injected arm. Next day or so noted increased tinnitus. I had tinnitus before but not like this. Very intense and doesn?t stop
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Client stated she felt dizzy briefly after the vaccine .  she recovered quickly to base line and was released.  Advised to seek medical attention later if needed.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Myalgia
Clinical narrative: sore arm at injection site (lasted a day and a half) muscle/joint aches/pains - ongoing - first day my body felt "heavy and slow" then by the nighttime my joints started to ache and by the next day they felt like someone had crawled inside me and punched my bones. By the fourth day, most joints and muscles feel close to normal except left hip and thigh which are still intensely painful especially when getting up and down from lying/sitting.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lacrimation increased, Malaise, Vital signs measurement
Clinical narrative: 03/07/2021 at 13:33 pm Observed patient sitting with tears in her eyes, when asked if she felt ok patient stated she just does not feel well. V/S BP 141/102, HR 90. Advised patient to sit for additional 15 minutes so that I can closely monitor her. Water given to patient and had her sit, 13:45 pm V/S BP 123/90, HR 90.  Patient stated at 13:50 pm that she felt much better and good to go.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Tinnitus
Clinical narrative: increasing tinnitus, lingering headaches
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Loss of personal independence in daily activities, Pain in extremity, Skin warm
Clinical narrative: Woke with intermittent but very sore left knee pain. Might have been a little warm to touch but not sure.  No past h/o of knee pain or injury. To date, still experiencing intermittent left knee pain - not red, warm or swollen. Today (3/23) left shoulder is also very sore - couldn't open her vitamin jar and feels like she's been shoveling sand. No noted redness, swelling or warmth. Also noting intermittent bilateral hand and ankle pain. No other associated symptoms. Patient states she doesn't feel she needs to be seen by PCP at this time. Writer recommended Ibuprofen as directed every 6-8 hours as long as she has no contraindications to taking Ibuprofen (denies h/o kidney or GI issues). Recommend f/u with PCP for further evaluation if no improvement w/i 24-48 hours or if symptoms worsen. She is in agreement. Recommend discuss with PCP whether she should have 2nd vaccine.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Hypoaesthesia oral, Oral blood blister
Clinical narrative: DIZZINESS, NUMBNESS IN FOREHEAD, NOSE AND UPPER LIP, THE NEXT DAY A CLOT ON THE LOWER LIP
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: High fever. Chills. Exhaustion
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was only 17 years old when she received dose number one.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site inflammation, Injection site pruritus, Injection site warmth, Pain, Product administered to patient of inappropriate age
Clinical narrative: Patient was only 17 years old when she received dose number one.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Presyncope
Clinical narrative: Patient had a vasovagal reaction and passed out.  EMS was called and he was taken to the ED.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site irritation, Injection site pruritus, Nausea
Clinical narrative: 1st day: Headache and nausea (both mild). 2nd day:  Arm pain (slight); 101.6 fever (no other symtoms). 3rd day: Arm swelling and pain. 3rd-4th day: Itchiness/irritation at injection site (left arm). Presently (almost 2 weeks later), itchiness, less swollen after massaging arm on 3/19/21, huge red ring around injection site.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: 1st day: Headache and nausea (both mild). 2nd day:  Arm pain (slight); 101.6 fever (no other symtoms). 3rd day: Arm swelling and pain. 3rd-4th day: Itchiness/irritation at injection site (left arm). Presently (almost 2 weeks later), itchiness, less swollen after massaging arm on 3/19/21, huge red ring around injection site.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Rash below injection site. Red, hot, and swollen.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Nausea, Oral mucosal blistering, Pain
Clinical narrative: Fever, chills, severe headache, nausea, aches, mouth blistered (inside and outside)
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Fever, chills, severe headache, nausea, aches, mouth blistered (inside and outside)
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oral mucosal blistering
Clinical narrative: Fever, chills, severe headache, nausea, aches, mouth blistered (inside and outside)
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Itchy Rash on upper body. Medro Dose Pack and Mometasone Furoate  topical cream, Benedryl
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood lactic acid, Chest pain, Computerised tomogram, Computerised tomogram abdomen
Clinical narrative: severe upper abdominal pain (esophagus). it was painful to breathe. a cold shiver throughout my entire body when i exhaled. vomiting .. i could not hold down water. went to urgent care and they referred me to the hospital ER.  they could not find anything wrong.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Culture urine, Electrocardiogram, Full blood count, Metabolic function test, Prothrombin time
Clinical narrative: severe upper abdominal pain (esophagus). it was painful to breathe. a cold shiver throughout my entire body when i exhaled. vomiting .. i could not hold down water. went to urgent care and they referred me to the hospital ER.  they could not find anything wrong.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin I, Urine analysis, Vomiting
Clinical narrative: severe upper abdominal pain (esophagus). it was painful to breathe. a cold shiver throughout my entire body when i exhaled. vomiting .. i could not hold down water. went to urgent care and they referred me to the hospital ER.  they could not find anything wrong.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Fatigue, Irritable bowel syndrome, Myalgia
Clinical narrative: muscle pain, joint pain, stomach discomfort, extreme fatigue, symptoms of Irritable Bowel Syndrome
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Streptococcus test
Clinical narrative: soreness in arm, nausea
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: metallic taste in mouth starting around 11:30 and lasting for 3 hours.  Metallic taste went away after 3 hours.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: When attempting to schedule dose #2, was advised by the family that the patient passed away on 3/13/2021.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: States she continues to lose her hair several weeks after first dose of vaccine.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Broke out in Hives, 4 days after injection from the Johnson & Johnson Vaccine, Took Antihistamine, gone 6 days outbreak.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Red at injection site and itching, not painful unless touched directly
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain
Clinical narrative: I sat, clinician stood. Shot felt weird when it happened - Deep, numb feeling but no feeling of being pricked by needle. Seemed to take a little longer than expected. (I had seen my dad get his and counted to 3 each time and I kept counting with mine, not sure when it was over.) I felt that the injection was too high on my shoulder and told clinician this after. I said it felt weird. She said I should feel stinging and that it went into the muscle. I never felt a stinging. After 15 minutes, I asked a different worker if the injection was too high and she said 2 or 3 fingers was appropriate and that it seemed okay. (Injection looks to be at about where the third finger would be from my shoulder bone. It is higher than I have had shots before. There was a little discomfort but real pain set in about two hours later and has continued. Upper and forearm pain. Tried a heating pad. Holding arm still. it doesn't hurt but does feel sore. Movement means sharp pain, especially in the upper arm. Would like to take Ibuprofen but not sure if it will hurt vaccine's effectiveness.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Feeling abnormal, Hypoaesthesia, Pain in extremity
Clinical narrative: I sat, clinician stood. Shot felt weird when it happened - Deep, numb feeling but no feeling of being pricked by needle. Seemed to take a little longer than expected. (I had seen my dad get his and counted to 3 each time and I kept counting with mine, not sure when it was over.) I felt that the injection was too high on my shoulder and told clinician this after. I said it felt weird. She said I should feel stinging and that it went into the muscle. I never felt a stinging. After 15 minutes, I asked a different worker if the injection was too high and she said 2 or 3 fingers was appropriate and that it seemed okay. (Injection looks to be at about where the third finger would be from my shoulder bone. It is higher than I have had shots before. There was a little discomfort but real pain set in about two hours later and has continued. Upper and forearm pain. Tried a heating pad. Holding arm still. it doesn't hurt but does feel sore. Movement means sharp pain, especially in the upper arm. Would like to take Ibuprofen but not sure if it will hurt vaccine's effectiveness.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Injection site pain, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Four hours after vaccine, patient noted pain surrounding injection site.  By 8 hours after vaccine, patient noted pain  had spread and extended from shoulder to elbow. By 18 hours after vaccine, the patient noted moderate muscle pain (myalgia) and joint pain (arthralgia) limiting ADL unrelieved by over-the-counter agents (ibuprofen, acetaminophen). These symptoms persisted through the second day and the patient noted new neck pain and headache, again unrelieved by over-the-counter agents.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: Four hours after vaccine, patient noted pain surrounding injection site.  By 8 hours after vaccine, patient noted pain  had spread and extended from shoulder to elbow. By 18 hours after vaccine, the patient noted moderate muscle pain (myalgia) and joint pain (arthralgia) limiting ADL unrelieved by over-the-counter agents (ibuprofen, acetaminophen). These symptoms persisted through the second day and the patient noted new neck pain and headache, again unrelieved by over-the-counter agents.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Musculoskeletal stiffness, Tenderness
Clinical narrative: Recipient had tenderness and warm to the touch behind right ear and right side of neck.  Hard time swallowing.  Could not turn his head.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: moderate tinnitus
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death within 60 days of vaccination
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Pharyngeal paraesthesia, Urticaria
Clinical narrative: Symptoms began with tingling in back of throat on left side.  Within 30 minutes I was having difficulty swallowing and hives began to appear on chest and arms.  I was given Benadryl through IV about 10:45.  I was taken by ambulance to hospital and remained there for about an hour and a half until symptoms subsided
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Injection site pain, Pain, Pain in extremity
Clinical narrative: Weakness, body aches, joint pain, left arm in pain, intermittent pain in right thigh
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Bladder catheterisation, Death, Dyspnoea, Hypotension, Intensive care
Clinical narrative: Unknown adverse event from vaccination. 3/14/21 Informed by caregiver that client was sent by ambulance to ER and diagnosed with bilat pneumonia.  She developed difficulty breathing on 3/13/21.  She was seen at Walk In on 3/12/21 for toenail eviscerated and INR, and had been giving tylenol for pain control for toe. 3/15/21 Informed by caregiver client was in ICU, septic, bilat pneumonia, and low oxygen levels. 3/16/21 Informed by caregiver client not doing well authorized indwelling cath due to low blood pressure and ventilator.  Client transfered by med flight to ICU. 3/17/21 Informed by caregiver client death last night.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical ventilation, Nail injury, Oxygen saturation decreased, Pneumonia, Sepsis
Clinical narrative: Unknown adverse event from vaccination. 3/14/21 Informed by caregiver that client was sent by ambulance to ER and diagnosed with bilat pneumonia.  She developed difficulty breathing on 3/13/21.  She was seen at Walk In on 3/12/21 for toenail eviscerated and INR, and had been giving tylenol for pain control for toe. 3/15/21 Informed by caregiver client was in ICU, septic, bilat pneumonia, and low oxygen levels. 3/16/21 Informed by caregiver client not doing well authorized indwelling cath due to low blood pressure and ventilator.  Client transfered by med flight to ICU. 3/17/21 Informed by caregiver client death last night.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Metamorphopsia
Clinical narrative: Dizzy. Mild headache. Intermittent vision distortion
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Fatigue, Headache, Injection site erythema
Clinical narrative: Shaking, joint pain, fever of 101, loss of appetite, headache, tiredness, nausea, pain and redness at injection site. These symptoms persisted for 48 hours.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Nausea, Pyrexia, Tremor
Clinical narrative: Shaking, joint pain, fever of 101, loss of appetite, headache, tiredness, nausea, pain and redness at injection site. These symptoms persisted for 48 hours.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pyrexia
Clinical narrative: Low grade fever x 7 days, fatigue, nausea
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Injection site pain, Nausea, Pyrexia
Clinical narrative: Low fever (100 F), pain at injection site, nausea and dizziness.  It lasted about 12 hours. I took a Tylenol when nausea subsided (in the afternoon).
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased, Hyperhidrosis, Nausea
Clinical narrative: Patient received Pfizer COVID 19 vaccine at 8:42am. This was patient's first dose. He was observed in clinic for 18 minutes afterwards without concern and left approximately 9:00am. Patient returned to clinic at 9:28am with complaints of sweating, nausea and lightheadedness. RN took patient to private observation room and started assessment. VS 9:30am O2 100%, BP 147/78, HR 50. Patient is laid back on bed with head at 45 degrees and legs elevated. Patient was given 6oz of water and neurological assessment completed. Patient alert and oriented without changes. Patient denies SOB, scratchy or tight throat, hoarse voice, trouble swallowing or itching. VS 9:40am O2 100%, BP 151/77, HR 54. Patient given another 6 oz of water and continues to lie back with feet elevated. Patient took clonidine, sertraline, propranolol, Adderall and vraylar this AM. He ate breakfast. Is not a diabetic. Patient states his lightheadedness has subsided, still complains of sweating and nausea but states he is "feeling better and ready to go home". Patient has a ride and is going home to his parent's house where they will both stay with him all day. VS 9:45 O2 100%, BP 143/81, HR 61. Patient appears more comfortable, less anxious and HR has risen. States his nausea is lessening. Patient would like to leave. RN educated patient on emergency signs to seek 911 for and they include SOB, throat swelling, sudden emesis, increased lightheadedness or nausea, fainting, new dizziness or any other sudden change in condition. He voices understanding; plans to go home with parents, have toast for lunch, push fluids and rest. Patient escorted to the door and visualized entering vehicle with family.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Presyncope
Clinical narrative: Anxious following vaccine with vasovagal response but no syncope.  Reclined in car seat with pulse of 67 Blood pressure of 92/49 and oxygen saturation of 97%.  EMS and Dr on site.  Client felt better quickly and was released.  Advised to seek medical attention later if needed.  Client stated understanding.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatic enzyme increased
Clinical narrative: I didn't have any major issues until I had to get blood drawn for my visit with my Endocrinologist. It showed that my liver enzymes were elevated. I am not sure if it's related, but I wanted to report it just in case.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Moderna COVID-19 Vaccine EUA. Adverse side effect; diarrhea.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Laboratory test abnormal
Clinical narrative: ABNORMAL LAB CHEST PAIN SHORTNESS OF BREATH
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram normal, Antinuclear antibody increased, Cardiac stress test normal, Chest pain, Echocardiogram abnormal
Clinical narrative: ABNORMAL LAB CHEST PAIN SHORTNESS OF BREATH
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ejection fraction normal, Electrocardiogram abnormal, Fibrin D dimer increased, Pain, Pericarditis
Clinical narrative: ABNORMAL LAB CHEST PAIN SHORTNESS OF BREATH
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Patient received first dose of Pfizer and started having tingling in her hands and feet. EMS responded and took Vital Signs, BP 130/80, O2 sats 99, HR 105. Patient had taken her personal albuterol inhaler prior to EMS response she stated. Patient refused any further treatment and had recovered within few minutes.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu like symptoms:  chills, achy body, slight fever, tiredness, allergies
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dyspnoea, Headache, Pain
Clinical narrative: Patient vaccinated 12/22/2020.  On 12/23/2021 patient had body aches, cough, headache, pharyngitis, and shortness of breath without hypoxia.  Outpatient infusion of bamlanivimab administered.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngitis, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated 12/22/2020.  On 12/23/2021 patient had body aches, cough, headache, pharyngitis, and shortness of breath without hypoxia.  Outpatient infusion of bamlanivimab administered.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Heart rate abnormal, Myalgia, Nausea, Pain in extremity
Clinical narrative: 103 degree temperature for 5-6 days, nausea, muscle aches, rapid heart rate, entire upper arm swollen and hot and painful with redness encompassing almost entire upper arm. I called my Doctor on 2/31/21 and had a Telegraph appointment. He ordered a tapering dose of prednisone. On 4/3/21 I called him after hours and he ordered an extra 20 mg of prednisone because the redness had continued to spread and he extended the prednisone taper.  The fever broke on 4/2/21 after using Tylenol every 6 hours for a week. My arm started to improve on the prednisone after a few days. I saw my Doctor in person on March 18 and there was still some red blotchiness in my arm. My doctor recommended that I not get the second dose.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Rash macular, Skin warm
Clinical narrative: 103 degree temperature for 5-6 days, nausea, muscle aches, rapid heart rate, entire upper arm swollen and hot and painful with redness encompassing almost entire upper arm. I called my Doctor on 2/31/21 and had a Telegraph appointment. He ordered a tapering dose of prednisone. On 4/3/21 I called him after hours and he ordered an extra 20 mg of prednisone because the redness had continued to spread and he extended the prednisone taper.  The fever broke on 4/2/21 after using Tylenol every 6 hours for a week. My arm started to improve on the prednisone after a few days. I saw my Doctor in person on March 18 and there was still some red blotchiness in my arm. My doctor recommended that I not get the second dose.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Swollen tongue
Clinical narrative: Moderna COVID-19 Vaccine EUA  Swelling of lips and tongue 1-2 hours after receiving the vaccine.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Erythema, Headache, Immune system disorder, Peripheral swelling
Clinical narrative: Arm swollen could not touch it for 3 days with red spots fever sinus infection headache lower back pain with still hurts today.  I have been to Chiropractor 3 times for some relief My husband had Covid and he did not suffer like this.  I never tested positive during mu husbands covid. This vaccine totally broke down my immune system which was high and attached me and still today. I will NOT be taking the 2nd dose
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sinusitis, Tenderness
Clinical narrative: Arm swollen could not touch it for 3 days with red spots fever sinus infection headache lower back pain with still hurts today.  I have been to Chiropractor 3 times for some relief My husband had Covid and he did not suffer like this.  I never tested positive during mu husbands covid. This vaccine totally broke down my immune system which was high and attached me and still today. I will NOT be taking the 2nd dose
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea
Clinical narrative: Nausea and migraine (began after a couple hours of vaccine receipt and worsened the next day)
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Myalgia, Pyrexia
Clinical narrative: 12 hrs after vaccination, developed chills, total body muscle aches, fever/sweating, intense headache. Symptoms persisted throughout night, with no relief from multiple doses of acetaminophen.  After taking 2 ibuprofen in morning, muscle aches and headache subsided.
Age: 6.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Injection site swelling, Pyrexia
Clinical narrative: THE DAY FOLLOWING VACCINATION, 3/19/21, MON NOTICED SWELING AROUND INJECTION SITE AND LOW GRADE FEVER.  THE SWELLING AND REDNESS WORSENED OVER 3/20 AND 3/21.  IT EXTENDED AT ITS WORST TO TOP SHOULDER AND JUST ABOVE  ELBOW.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Injection site induration, Injection site pain
Clinical narrative: After Injection  pain,  swelling (hardness) in arm; Sunday side effects  joint pain; Monday  fatigue , awaken in sweat, dizziness, nausea and vomiting  for 10minutes; No fever; Tuesday fatigue, No fever 96.6; little dizziness and nausea.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Nausea, Night sweats, Vomiting
Clinical narrative: After Injection  pain,  swelling (hardness) in arm; Sunday side effects  joint pain; Monday  fatigue , awaken in sweat, dizziness, nausea and vomiting  for 10minutes; No fever; Tuesday fatigue, No fever 96.6; little dizziness and nausea.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Nausea
Clinical narrative: Had the injection 3/21/2021 at 2:30.  On 3/22/2021, the next morning after the injection had nausea, flu-like symptoms, and slept all day.  Took two advil and one tylenol at 6:30 am, 2:00 pm and again at 10 pm.   On 3/23/2021, woke up 7 am in the morning and felt fine.
Age: 18.0
Sex: F
Vaccine: FLU4, HEPA, HPV9, MENB, UNK
Symptoms: Headache, Pain in extremity
Clinical narrative: pain in both arm; headache; Information has been received from a healthcare professional via Food and Drug Administration (agency # 847291-1) on 22-OCT-2020 referring to an 18 years old female patient, who was not pregnant. The patient had no prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at the time of vaccination. Allergies to medications, food, or other products were unknown. The patient had none other illnesses at the time of vaccination and up to one month prior and no chronic or longstanding health conditions. The patient had no adverse event following any previous vaccine.  On 11-NOV-2019 at 8:00 am, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose 2, lot number 1314898 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast); dose was not reported) via intramuscular in the left arm for prophylaxis. Other suspect therapies included meningococcal b rfhbp rnada rnhba omv vaccine (e.coli) (BEXSERO) (lot# GSKABXA14AB, dose # 1) via intramuscular in the right arm for prophylaxis, influenza virus split virion 4v vaccine inactivated (FLUARIX QUADRIVALENT) (lot# GSK3GG33, dose # 1) via intramuscular in the right arm for prophylaxis and hepatitis a virus vaccine inactivated (HAVRIX) (lot# GSKBESS4, dose # 1) via intramuscular in the left arm for prophylaxis.      On 12-NOV-2019 at 9:00 am, the day after receiving vaccines, the patient came to the school health suite complaining of pain in both arms. School nurse administered 650mg acetaminophen. The patient returned after 2 hours saying that acetaminophen did not help arm pain and was now complaining of headache. The patient dismissed from school early. The patient returned to school the following day (2days after receiving vaccines). Result or outcome of adverse event was reported as none. None medical tests and laboratory results related to the adverse event(s) were performed. Outcome of the events was recovered.  The causal relationship between suspect products and the events was not reported.  Follow up information was received from the Nurse Practitioner, on 17-MAR-2021. The lot # for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, was 1614898 (expiration date not reported, but upon internal validation established as 15-NOV-2021).  Patient's demographics were updated. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Illness, Immune system disorder, Injection site pain, Injection site pruritus
Clinical narrative: Long line of itchy burning rash / Worse that the original shingles/Iitching at the site; My immune system went into overdrive; Low fever; Long line of itchy burning rash / Worse that the original shingles/ Burning / at the site; Felt sick for over a month; This case was reported by a consumer via interactive digital media and described the occurrence of itchy rash in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included shingles vaccine (1st dose received on an unknown date, non- gsk vaccine). Concurrent medical conditions included pain.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced itchy rash, immune system disorder, sickness, fever and burning sensation. On an unknown date, the outcome of the itchy rash, immune system disorder, sickness, fever and burning sensation were unknown.   It was unknown if the reporter considered the itchy rash, immune system disorder, sickness, fever and burning sensation to be related to Shingles vaccine.  Additional details were provided as follows: Age at vaccination was not reported. The age group was not reported but selected adult as per vaccine indication. The patient had shingles along the ribs on right side. It was caught early and had the oral medicines and than received the first vaccine. The patient was still having pain so when the new vaccine came, the patient received it. This was about 4 years after the original shingles outbreak. On the third day after the shot, the patient actually broke out with a long line of itchy burning rash, it was worse that the original shingles. The patient's doctor told to not to get the booster shot as patient's immune system went into overdrive. The patient felt sick for over a month with low fever and burning and itching at the site. The patient had been dealing with this now for about 4 years and at least twice a month it will itch and burn in that same area but no rash. The patient guess it would never go completely away and learned to grin and bear it. The patient did not consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia, Rash pruritic
Clinical narrative: Long line of itchy burning rash / Worse that the original shingles/Iitching at the site; My immune system went into overdrive; Low fever; Long line of itchy burning rash / Worse that the original shingles/ Burning / at the site; Felt sick for over a month; This case was reported by a consumer via interactive digital media and described the occurrence of itchy rash in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included shingles vaccine (1st dose received on an unknown date, non- gsk vaccine). Concurrent medical conditions included pain.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced itchy rash, immune system disorder, sickness, fever and burning sensation. On an unknown date, the outcome of the itchy rash, immune system disorder, sickness, fever and burning sensation were unknown.   It was unknown if the reporter considered the itchy rash, immune system disorder, sickness, fever and burning sensation to be related to Shingles vaccine.  Additional details were provided as follows: Age at vaccination was not reported. The age group was not reported but selected adult as per vaccine indication. The patient had shingles along the ribs on right side. It was caught early and had the oral medicines and than received the first vaccine. The patient was still having pain so when the new vaccine came, the patient received it. This was about 4 years after the original shingles outbreak. On the third day after the shot, the patient actually broke out with a long line of itchy burning rash, it was worse that the original shingles. The patient's doctor told to not to get the booster shot as patient's immune system went into overdrive. The patient felt sick for over a month with low fever and burning and itching at the site. The patient had been dealing with this now for about 4 years and at least twice a month it will itch and burn in that same area but no rash. The patient guess it would never go completely away and learned to grin and bear it. The patient did not consented to follow up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient had shingles after receiving the two shingles shots. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles and exact time to onset were unknown.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site nodule, Injection site pain, Injection site swelling, Insomnia, Muscle tightness
Clinical narrative: muscle pain presented in her right arm; muscle is tensing up; unable to sleep on her right side due to the pain; pain as though her muscle feels like it is in a bind and it won't pop out of it / pushes or pulls / intense pain / down her arm to the elbow; bump or knot at the injection site; shot itself was painful; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included sepsis (Lost fingers on right hand and all toes due to being septic) and streptococcal sore throat.   On 28th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 28th October 2020, immediately after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the patient experienced injection site swelling, myalgia upper extremities, muscle tension, sleeplessness and pain in arm. On an unknown date, the outcome of the injection site swelling and myalgia upper extremities were not recovered/not resolved and the outcome of the injection site pain was recovered/resolved and the outcome of the muscle tension, sleeplessness and pain in arm were unknown.   It was unknown if the reporter considered the injection site swelling, injection site pain, myalgia upper extremities, muscle tension, sleeplessness and pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient reported case for herself. The patient received vaccine in right arm. The patient said the shot itself was painful but she did not experience any other side effects until one month later when muscle pain presented in her right arm.  At first she thought it was her shoulder and had an x-ray but that did not show any damage.  She described the pain as though her muscle feels like it was in a bind and it would not pop out of it.  Like the muscle was tensing up.  When she pushes or pulls, an intense pain shoots down her arm to the elbow.  She was unable to sleep on her right side due to the pain. She reported that she could see a bump or knot at the injection site. The reporter consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, X-ray normal
Clinical narrative: muscle pain presented in her right arm; muscle is tensing up; unable to sleep on her right side due to the pain; pain as though her muscle feels like it is in a bind and it won't pop out of it / pushes or pulls / intense pain / down her arm to the elbow; bump or knot at the injection site; shot itself was painful; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included sepsis (Lost fingers on right hand and all toes due to being septic) and streptococcal sore throat.   On 28th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 28th October 2020, immediately after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the patient experienced injection site swelling, myalgia upper extremities, muscle tension, sleeplessness and pain in arm. On an unknown date, the outcome of the injection site swelling and myalgia upper extremities were not recovered/not resolved and the outcome of the injection site pain was recovered/resolved and the outcome of the muscle tension, sleeplessness and pain in arm were unknown.   It was unknown if the reporter considered the injection site swelling, injection site pain, myalgia upper extremities, muscle tension, sleeplessness and pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient reported case for herself. The patient received vaccine in right arm. The patient said the shot itself was painful but she did not experience any other side effects until one month later when muscle pain presented in her right arm.  At first she thought it was her shoulder and had an x-ray but that did not show any damage.  She described the pain as though her muscle feels like it was in a bind and it would not pop out of it.  Like the muscle was tensing up.  When she pushes or pulls, an intense pain shoots down her arm to the elbow.  She was unable to sleep on her right side due to the pain. She reported that she could see a bump or knot at the injection site. The reporter consented to follow up.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Bilateral pulmonary emboli; A spontaneous report  was received from a physician concerning an 80-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) experienced shortness of breath and oxygen level low.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received her first of two planned doses of mRNA-1273 (LOT: unknown) on 05-Feb-2021.  On 05-Mar-2021, approximately 1 day prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 048A21A) intramuscularly for prophylaxis of COVID-19 infection.    On 06-Mar-2021, the patient developed shortness of breath and her oxygen level was low.  On 09-Mar-2021, she was diagnosed with bilateral pulmonary embolisms. No hospitalization was required. The reporter stated that the patient had no history of blood clots.    Treatment for the event included apixaban.    The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: death 2 and half hours after receiving the first Moderna vaccine; A Spontaneous report was received from  a health care professional concerning a 61 year old male patient,who received Moderna's COVID-19 vaccine (mRNA-1273) and reported death.  The patient's medical history as provided by the reporter included diabetes, history of shortness of breath, cardiac history. Concomitant medications included metoprolol, metformin and glipizide.  On 05 Mar 2021, prior to the onset of events the patient received his first dose of their two planned doses of mRNA-1273 (Batch N0: 030a21a) intramuscularly for prophylaxis of covid 19 infection.  On 05 Mar 2021,it was reported that the patient died 2 and half hours after receiving the first Moderna vaccine. The patient had no symptoms during observation 15 minutes after receiving fist Moderna vaccine.The patient's PCP ordered an autopsy.  Treatment information not included.   Action taken with mRNA-1273 in response to the events was not applicable.  On 05 Mar 2021, it was reported that the patient died.; Reporter's Comments: This is a case of sudden death in a 61-year-old male subject with hx of diabetes, history of shortness of breath and cardiac history, who died 2 1/2 hours after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: unknown cause of death