chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: X-ray
Clinical narrative: By the end of the day, my arm was sore to the touch. The next morning, I had a 6 inch red, goose egg on the inside of my left arm, running from my elbow to armpit. While the swelling and tenderness subsided by the following Monday, I continued to have a series of sharp pains and dull aches in my left arm for weeks. I contacted the provider who thought that I had reacted to the preservative in the vaccine. After about 6 weeks of the ongoing pain, I had x-rays, saw an orthopedic doc, had an MRI, saw the orthopedic doc again, was referred to a pain management specialist (he wanted me to have another in-depth MRI with dye on my shoulder), have had massage therapy, seen a reflexologist twice, seen a chiropractic provider four times and now working with a kinesiologist twice a week to get my arm retrained and strengthened. I had absolutely no underlying health issues before the vaccine and following my visit with the pain management doc, he too believes my issues are directly related to this vaccine. Believe me, if I'd had any indication this would occur, I would never have agreed to this vaccination. Subsequently, I have had two Moderna vaccinations in the past 6 weeks with absolutely no side effects other than a bit of soreness in my arm the following day.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus, Rash
Clinical narrative: Patient reports she was itchy the morning after vaccination and noticed a rash appearing on 03/04/2021 with worsening rash symptoms on 03/06/2021. Patient reports she waited until 03/08/2021 to see if rash would resolve, when it did not she report she went to  Urgent Care,  to checked. Patient reports UC provider treated her for allergic reaction and gave her a IM injection; which patient reports has helped her symptoms tremendously.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dermatitis diaper, Dry skin, Oral pain, Rash, Skin exfoliation
Clinical narrative: All reactions were on the left side of the body: Rash on neck, cracked toes and skin coming off the entire foot, vagina area affected, red and dry labia, diaper rash on the buttocks more to the left, mouth was sore, felt raw and cut, red spots on the entire face. Overall severe dry skin
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vulvovaginal dryness, Vulvovaginal erythema
Clinical narrative: All reactions were on the left side of the body: Rash on neck, cracked toes and skin coming off the entire foot, vagina area affected, red and dry labia, diaper rash on the buttocks more to the left, mouth was sore, felt raw and cut, red spots on the entire face. Overall severe dry skin
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Chest discomfort, Chest pain, Chills, Dyspnoea
Clinical narrative: Symptoms from vaccine did not start until Day 5. I woke up at 0900 with a sore arm, nausea, headache, generalized aches, chills. By that evening (unsure of time), started with my usual asthma flare-up symptoms. These include, soreness of breath, chest tightness and pain, wheezing. I started treatment at home with q4h DuoNeb breathing treatments and a decreasing prednisone prescription.  This treatment did not work so I followed up with my pulmonologist and his PA-C for a follow-up. They made the decision that this flare up was caused "by my immune response to the covid vaccine."
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pain in extremity, Vaccination complication
Clinical narrative: Symptoms from vaccine did not start until Day 5. I woke up at 0900 with a sore arm, nausea, headache, generalized aches, chills. By that evening (unsure of time), started with my usual asthma flare-up symptoms. These include, soreness of breath, chest tightness and pain, wheezing. I started treatment at home with q4h DuoNeb breathing treatments and a decreasing prednisone prescription.  This treatment did not work so I followed up with my pulmonologist and his PA-C for a follow-up. They made the decision that this flare up was caused "by my immune response to the covid vaccine."
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Symptoms from vaccine did not start until Day 5. I woke up at 0900 with a sore arm, nausea, headache, generalized aches, chills. By that evening (unsure of time), started with my usual asthma flare-up symptoms. These include, soreness of breath, chest tightness and pain, wheezing. I started treatment at home with q4h DuoNeb breathing treatments and a decreasing prednisone prescription.  This treatment did not work so I followed up with my pulmonologist and his PA-C for a follow-up. They made the decision that this flare up was caused "by my immune response to the covid vaccine."
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Migraine, Neuralgia, Pyrexia, Skin lesion
Clinical narrative: She received the vaccine, had a terrible migraine and laid in the bed for 2 days.  Had a fever, felt like she had the flu about 24 hours after she received the vaccine.  These symptoms went away and around the 3rd day was fine.   Then a week after that she developed shingles on her left butt cheek.  It started off as a shingles red rash, and now has lesions that she has to go to a wound clinic.  She developed a fever, and now has nerve pain due to the singles.  It is only on the side that she received the vaccine on, the left side.   She did a telemed appointment on 2/24/21, no 2/25/21 went to a respiratory clinic as they were concerned about COVID.  She then went back to the dr. last week as the lesion on her buttock is not healing, and now being referred to hospital to go to the wound clinic.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Pain in extremity, X-ray
Clinical narrative: Pain in left arm from shoulder to elbow. Can?t lift arm above head or behind back without intense pain.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: 3? x4? red rash at injection site Warm to touch Painful Chills and aches
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: 3? x4? red rash at injection site Warm to touch Painful Chills and aches
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Erythema, Herpes zoster, Rash
Clinical narrative: Patient experiences a shingles like rash after dose #1 .  STarted 6 days after vaccine.  Provider treated herpes zoster with acyclovir.  Rash - several blisters on left side of lower chest, erythema present.   Did receive 2nd dose on schedule.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: R thigh with erythema, warmth, tenderness, and induration
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adenovirus test, Cytomegalovirus test negative, Epstein-Barr virus antibody, Epstein-Barr virus antigen positive, Epstein-Barr virus test positive
Clinical narrative: Patient presented to BIDMC on 02/23/21 with ~5d of sore throat and intractable fever and was found to have fulminant myocarditis.  She required ICU stay with VA ECMO and Impella circulatory support from 02/25/21-03/03/21.  She received a course of hydrocortisone. Cause of myocarditis was unclear but felt to be viral or post-viral versus inflammatory.  As of this submission she has been transferred to the cardiac floor and seems to be recovering.  Symptoms started ~14d after 1st dose COVID vaccine.  She also had self limited COVID infection in early January, 2021.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Intensive care, Myocarditis, Oropharyngeal pain, Pyrexia, Respiratory viral panel
Clinical narrative: Patient presented to BIDMC on 02/23/21 with ~5d of sore throat and intractable fever and was found to have fulminant myocarditis.  She required ICU stay with VA ECMO and Impella circulatory support from 02/25/21-03/03/21.  She received a course of hydrocortisone. Cause of myocarditis was unclear but felt to be viral or post-viral versus inflammatory.  As of this submission she has been transferred to the cardiac floor and seems to be recovering.  Symptoms started ~14d after 1st dose COVID vaccine.  She also had self limited COVID infection in early January, 2021.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Patient presented to BIDMC on 02/23/21 with ~5d of sore throat and intractable fever and was found to have fulminant myocarditis.  She required ICU stay with VA ECMO and Impella circulatory support from 02/25/21-03/03/21.  She received a course of hydrocortisone. Cause of myocarditis was unclear but felt to be viral or post-viral versus inflammatory.  As of this submission she has been transferred to the cardiac floor and seems to be recovering.  Symptoms started ~14d after 1st dose COVID vaccine.  She also had self limited COVID infection in early January, 2021.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood culture, Blood pressure decreased, Blood pressure measurement, C-reactive protein, Cardiogenic shock
Clinical narrative: Patient presented to BIDMC on 02/23/21 with ~5d of sore throat and intractable fever and was found to have fulminant myocarditis.  She required ICU stay with VA ECMO and Impella circulatory support from 02/25/21-03/03/21.  She received a course of hydrocortisone. Cause of myocarditis was unclear but felt to be viral or post-viral versus inflammatory.  As of this submission she has been transferred to the cardiac floor and seems to be recovering.  Symptoms started ~14d after 1st dose COVID vaccine.  She also had self limited COVID infection in early January, 2021.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Ejection fraction, Haemorrhage, Interleukin-2 receptor assay, Investigation
Clinical narrative: Patient presented to BIDMC on 02/23/21 with ~5d of sore throat and intractable fever and was found to have fulminant myocarditis.  She required ICU stay with VA ECMO and Impella circulatory support from 02/25/21-03/03/21.  She received a course of hydrocortisone. Cause of myocarditis was unclear but felt to be viral or post-viral versus inflammatory.  As of this submission she has been transferred to the cardiac floor and seems to be recovering.  Symptoms started ~14d after 1st dose COVID vaccine.  She also had self limited COVID infection in early January, 2021.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Myocarditis, Peripheral swelling, Pyrexia, Respiratory failure
Clinical narrative: Patient presented to BIDMC on 02/23/21 with ~5d of sore throat and intractable fever and was found to have fulminant myocarditis.  She required ICU stay with VA ECMO and Impella circulatory support from 02/25/21-03/03/21.  She received a course of hydrocortisone. Cause of myocarditis was unclear but felt to be viral or post-viral versus inflammatory.  As of this submission she has been transferred to the cardiac floor and seems to be recovering.  Symptoms started ~14d after 1st dose COVID vaccine.  She also had self limited COVID infection in early January, 2021.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Serum ferritin, Thrombocytopenia, Thrombosis
Clinical narrative: Patient presented to BIDMC on 02/23/21 with ~5d of sore throat and intractable fever and was found to have fulminant myocarditis.  She required ICU stay with VA ECMO and Impella circulatory support from 02/25/21-03/03/21.  She received a course of hydrocortisone. Cause of myocarditis was unclear but felt to be viral or post-viral versus inflammatory.  As of this submission she has been transferred to the cardiac floor and seems to be recovering.  Symptoms started ~14d after 1st dose COVID vaccine.  She also had self limited COVID infection in early January, 2021.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site warmth, Migraine
Clinical narrative: Seven days after first dose, I developed migraine symptoms and shortly afterwards a "rash" bloomed around the vaccination site on my right arm. I took Advil for the headache, which diminished but didn't remove the pain/discomfort. But it lasted only 24 hours. The "rash" area became brighter and larger over 48 hours, and is now diminishing. The site was hot, itchy, tender. The arm's surface remained smooth.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Patient developed dizziness, lightheadedness, ~30 minutes after vaccine administration, which persisted despite conservative treatment for possible vasovagal episode.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Decreased appetite, Fatigue
Clinical narrative: Patient reported losing her "taste buds" and also did not feel hungry and was tired around 3 days after her second dose of the Pfizer-BioNTech COVID-19 vaccination. Patient said this has now resolved but did not state exactly when it resolved.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chapped lips, Chills, Hot flush, Pruritus
Clinical narrative: I almost immediately felt something behind my sinuses and at the injection site and ignored it, however, about 50 hours later I started itching around my neck and chest, then arms and back, face, and hands, knees, etc. I called the pharmacy on Saturday to make sure I could take Allegra for the itching and they said I could take what I had (Allegra). The itching did subside until Sunday afternoon and a stomach ache began. I have had stomachaches before, not infrequently, but this ache was more like acid indigestion. The stomach ache persisted and I took an antacid and fell asleep.  The ache has persisted and is still bothering me. Along with the itch came sneezing and a runny nose which has not been as persistent as the itch and stomachache, but still ongoing. I don't know if my chapped lips are due to the vaccine or not, but I seem to have chapped lips out of character. I have also experienced hot flashes and chills intermittently.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: I almost immediately felt something behind my sinuses and at the injection site and ignored it, however, about 50 hours later I started itching around my neck and chest, then arms and back, face, and hands, knees, etc. I called the pharmacy on Saturday to make sure I could take Allegra for the itching and they said I could take what I had (Allegra). The itching did subside until Sunday afternoon and a stomach ache began. I have had stomachaches before, not infrequently, but this ache was more like acid indigestion. The stomach ache persisted and I took an antacid and fell asleep.  The ache has persisted and is still bothering me. Along with the itch came sneezing and a runny nose which has not been as persistent as the itch and stomachache, but still ongoing. I don't know if my chapped lips are due to the vaccine or not, but I seem to have chapped lips out of character. I have also experienced hot flashes and chills intermittently.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death within 30 days of vaccination
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: "Covid Arm." Itchy, red, patch about 5 inches in diameter at injection site. Started 9 days after shot. Getting better, treated with antihistamine cream.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Hot flush, Influenza like illness, Myalgia
Clinical narrative: Flu like Muscle aches, hot flashes & chills,  lack of energy
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Back pain, Chills, Fatigue, Headache
Clinical narrative: My shot was at noon on March 5. That evening around 9 pm I started feeling very sore on my arm where the shot took place.  During the night and throughout the next day and night of March 6 I felt bad. I had a fever that ranged from 100.3 to 101.5. I had chills, a backache, headache, slight upset stomach, tiredness,  overall feeling of malaise, and a  sore arm at the shot site which became somewhat swollen and was red all around it. I really did not want to take Tylenol since I was concerned as to not knowing if it would interfere with antibody production.  After my first shot, I had to take Tylenol since my headache became unbearable. After this shot, it was not unbearable so I did not take any Tylenol.  When waking up at 8:00 am on March 7, I felt better. Only symptom that remained was redness and some soreness around shot area. That diminished each day for the next few days.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Malaise, Pyrexia
Clinical narrative: My shot was at noon on March 5. That evening around 9 pm I started feeling very sore on my arm where the shot took place.  During the night and throughout the next day and night of March 6 I felt bad. I had a fever that ranged from 100.3 to 101.5. I had chills, a backache, headache, slight upset stomach, tiredness,  overall feeling of malaise, and a  sore arm at the shot site which became somewhat swollen and was red all around it. I really did not want to take Tylenol since I was concerned as to not knowing if it would interfere with antibody production.  After my first shot, I had to take Tylenol since my headache became unbearable. After this shot, it was not unbearable so I did not take any Tylenol.  When waking up at 8:00 am on March 7, I felt better. Only symptom that remained was redness and some soreness around shot area. That diminished each day for the next few days.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Immediate post-injection reaction
Clinical narrative: immediate low blood pressure after  vaccine
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Lacrimation increased
Clinical narrative: watery eyes,  dizziness, headache  BP 140/61 HR 90 Pulse ox 96%on RA
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Fatigue, Feeling abnormal, Myalgia, Restlessness
Clinical narrative: Restless sleep, brain fog upon awakening, quite a bit of bone pain and muscular aches, fatigue . Lasted most of day after injection.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Restless sleep, brain fog upon awakening, quite a bit of bone pain and muscular aches, fatigue . Lasted most of day after injection.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Nausea, Pyrexia
Clinical narrative: 4 hours later, fever of 101, chills , muscle aches, nausea, continues 24 hours + later
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Fatigue, Malaise, Myalgia, Nausea
Clinical narrative: One hour and 15 min after the shot extreme fatigue began. Also my Left Arm was hurting. Then when I got in bed at 10pm, all of my muscles began hurting really badly, and I was awake most of the night, feeling sick with nausea, dry mouth, and pain all over. The next day I felt really wrecked, way worse than my usual Fibromyalgia/Anxiety symptoms. My body really hurt all over and I was really fatigued. I felt general malaise all day long and my left arm hurt a lot. That second night I slept better and the next day I was better except my left arm was still sore that day also.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Sleep disorder
Clinical narrative: One hour and 15 min after the shot extreme fatigue began. Also my Left Arm was hurting. Then when I got in bed at 10pm, all of my muscles began hurting really badly, and I was awake most of the night, feeling sick with nausea, dry mouth, and pain all over. The next day I felt really wrecked, way worse than my usual Fibromyalgia/Anxiety symptoms. My body really hurt all over and I was really fatigued. I felt general malaise all day long and my left arm hurt a lot. That second night I slept better and the next day I was better except my left arm was still sore that day also.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Dyspnoea, Lung opacity
Clinical narrative: I began experiencing shortness of breath  the day after the vaccine. I went to my primary care physician and he referred me for a chest xray. There was a small area of linear opacity near the right lung base. This could be related to atelectasis or acute infection. The remainder of the lungs clear, no pleural effusions. Heart size not enlarged. Normal contour of the mediastinum. No acute osseous findings.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Dizziness, Pruritus
Clinical narrative: Patient complained of itching all over, coughing, dizziness and chest pain. Happened about 7 minutes after her first dose of the Pfizer vaccine.  Vital signs were within normal range while evaluating her. EMS was called but patient refused to go to the hospital.  She stayed for a hour, while constantly being evaluated.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Limb discomfort, Pruritus, Rash erythematous
Clinical narrative: Itchy hands and feet. Red dots on hands and feet. Feels almost like blisters on toes. Hands feels like recovering from being ?burned? like on a stove.  - minor red spots, not fully covered - about 6 on my hands - about 4 on my feet   - unsure if vaccine caused this but wanted to report anyways  - happened  10/11 days after vaccine
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Skin warm
Clinical narrative: Patient experienced warm itchy rash that extended down past elbow
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Lethargy, Nausea, Pyrexia
Clinical narrative: Shaking fever and chills all night, waking up every two hours freezing cold despite lots of clothing and blankets. Woke up today feeling slightly better but still have a slight fever today, chills, and naesuea. Super lethargic and monitoring my condition daily.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Tremor
Clinical narrative: Shaking fever and chills all night, waking up every two hours freezing cold despite lots of clothing and blankets. Woke up today feeling slightly better but still have a slight fever today, chills, and naesuea. Super lethargic and monitoring my condition daily.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Patient reports sore arm and fatigue lasting 3 days post vaccine. On 03/9/2021 associate reports symptoms of headache and runny nose. Been tested for COVID-19 and awaiting results.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abnormal behaviour, Unresponsive to stimuli
Clinical narrative: After receiving vaccine patient became unresponsive and had ?posturing like behavior.  After a minute or two patient responded to strong sternal rub and was transported to ER for further evaluation.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Presyncope
Clinical narrative: After receiving vaccine patient became unresponsive and had ?posturing like behavior.  After a minute or two patient responded to strong sternal rub and was transported to ER for further evaluation.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abnormal behaviour, Unresponsive to stimuli
Clinical narrative: The patient transferred from Hospital's COVID-19 Vaccine Clinic to Emergency Department and evaluated by the provider for near syncope event post vaccination.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Presyncope
Clinical narrative: The patient transferred from Hospital's COVID-19 Vaccine Clinic to Emergency Department and evaluated by the provider for near syncope event post vaccination.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Presyncope
Clinical narrative: Patient developed dizziness, lightheadedness 30 minutes after vaccine. Was treated conservatively as vasovagal, without resolution and was transferred to local ER for further workup.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: THE PATIENT RECEIVED EXPIRED VACCINE ( OVER ROOM TEMP AFTER 6 HOURS).
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: There was fluid found in the cap of the 3ml syringe and the vaccinator suspected that less than 1/2 of the 0.5ml dose was administered.  The patient and family member were alerted immediately.Moderna was contacted and case created, and we were advised to call the patient back ASAP for vaccine admin of 0.5 ml in the opposite arm.  The patient is scheduled to return on 3/11/21 for vaccination.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site pruritus
Clinical narrative: The area was itchy and at this point around the shot it's black and blue.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Hot flush
Clinical narrative: brief dizziness followed by onset of chills and muscle aches that lasted for approximately 2 hours.  Now, approximately 22 hours later, I am experiencing fatigue, light nausea, headache, and hot flashes.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: brief dizziness followed by onset of chills and muscle aches that lasted for approximately 2 hours.  Now, approximately 22 hours later, I am experiencing fatigue, light nausea, headache, and hot flashes.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash papular
Clinical narrative: raised, red rash bilateral hands from inside of thumbs to mid-forarm.  provided 50mg of diphenhydramine.  observed patient for additional 30 minutes.  rash decreased in severity and there were no other symptoms (difficulty breathing, increased heart rate, etc)
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax, Dyspnoea
Clinical narrative: 24hours after immunization patient experienced dyspnea - called office 3-8-21 - referred for CTA chest given symptoms + for bilateral pulmonary emboli, NO history of such and NO obvious predisposing risk
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax, Pulmonary embolism
Clinical narrative: 24hours after immunization patient experienced dyspnea - called office 3-8-21 - referred for CTA chest given symptoms + for bilateral pulmonary emboli, NO history of such and NO obvious predisposing risk
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Swelling of injection sight area  red rash about 2 inches round and swelling about same.  I did take a picture of it.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Nausea, Sleep disorder
Clinical narrative: Next day nausea, tiredness, weakness, loss of sleep/ following day shortness of breath, sneezing-- asthmatic chronic affect treated with use of albuterol inhalant
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: Next day nausea, tiredness, weakness, loss of sleep/ following day shortness of breath, sneezing-- asthmatic chronic affect treated with use of albuterol inhalant
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Nausea, Psoriasis, Pyrexia, Rosacea
Clinical narrative: Nausea, low grade fevers, lethargy ,Psoriasis  Rosasea a few days after but dermatologist didn't think it was from the vaccine
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: COVID-19 Vaccine EUA  Slight consistent dizziness
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea
Clinical narrative: Chills, fatigue, nausea
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm
Clinical narrative: eye twitching; all day and sporadic the next day
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Computerised tomogram head, Disorientation, Dizziness, Dyspnoea
Clinical narrative: Dizzy, elevated  BP.  Her other vitals were normal. Pt was disoriented. Had taken BP meds that morning, had not eaten food since previous evening. During time pt was being monitored approx 45mins, she became nauseous, SOB, lightheaded and had chest pain with exertion.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Full blood count, Hypertension, Metabolic function test, Nausea
Clinical narrative: Dizzy, elevated  BP.  Her other vitals were normal. Pt was disoriented. Had taken BP meds that morning, had not eaten food since previous evening. During time pt was being monitored approx 45mins, she became nauseous, SOB, lightheaded and had chest pain with exertion.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness. Drank half cup of water, resolved. BPs 99/52 (pulse 78), 100/54 (pulse 72). O2 sats 100%.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: She started feeling dizzy and nauseous 2 to 3 minutes after receiving the vaccine. According to her mother, she is known to have hypoglycemia after any injections. She received a sip of coke and she started feeling better after 2 to 3 minutes. EMT checked on her and she refused to go to hospital to further getting checked up. She was able to walk with an assistance from one of the associates and go home with her mother.
Age: 67.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Feeling abnormal
Clinical narrative: I feel like I am dying. I really do not wish to take the second dose.  This is scary!
Age: 67.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Chills, Feeling abnormal, Hypophagia
Clinical narrative: I feel like I am dying. I really do not wish to take the second dose.  This is scary!
Age: 67.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Malaise, Pain, Renal pain
Clinical narrative: I feel like I am dying. I really do not wish to take the second dose.  This is scary!
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever (102.8), severe headache, moderate body aches, mild nausea.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Anxiety, Dyspnoea, Fatigue, Head discomfort
Clinical narrative: Neuropathy, Anxiety, Nausea, Vivid dreams, Head squeezing, Shortness of breath, Fatigue, Light Sensitivity. Going on a week now This was my first vaccine.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neuropathy peripheral, Photophobia
Clinical narrative: Neuropathy, Anxiety, Nausea, Vivid dreams, Head squeezing, Shortness of breath, Fatigue, Light Sensitivity. Going on a week now This was my first vaccine.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Cold sweat, Diarrhoea, Fatigue, Feeling hot
Clinical narrative: Three hours after shot: clear runny nose- constant drip. Around 11pm same evening: woke up clammy  6:30 next day: Headache. Very Sore . Felt like I?d been tubing on the lake all day. Took ibuprofen and felt better.  Very tired. 9:00 pm: very bad stomach cramps. Diarrhea started around 11pm. Many times. 7:30am  next morning (3/10): faster heart rate. Stomach hurt but not as bad. Little headache. Hot and clammy.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Pain, Rhinorrhoea
Clinical narrative: Three hours after shot: clear runny nose- constant drip. Around 11pm same evening: woke up clammy  6:30 next day: Headache. Very Sore . Felt like I?d been tubing on the lake all day. Took ibuprofen and felt better.  Very tired. 9:00 pm: very bad stomach cramps. Diarrhea started around 11pm. Many times. 7:30am  next morning (3/10): faster heart rate. Stomach hurt but not as bad. Little headache. Hot and clammy.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Injection site pain, Nausea, Pain, Pyrexia
Clinical narrative: Mild pain right after the injection lasted for about 30 seconds. About 8 hours later, I started getting some nausea and an upset stomach, along with some mild aches and pains. After taking a short nap, I woke up feeling a little feverish (though no fever).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pyrexia
Clinical narrative: fever for 12 hours  high temp 101.5,  joint pain,  tiredness    Felt normal 48 hours later
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: body aches starting the next day and lasting a full day
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Feeling abnormal
Clinical narrative: Tiredness, mind fog, diarrhea
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient received a COVID-19 vaccine on 06MAR21 @ 1030.  Approximately 2 hours later, she began developing a reddened area on her arm at the injection site which was hot to touch and became itchy.  She reached out to our onsite nurse on 08MAR21.  She iced the area and took Benadryl.  She was told to follow-up with our onsite nurse if her condition didn't improve.  On 10MAR21, she reported she has been taking Benadryl HS and the area is "almost completely cleared up."
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Diarrhoea, Headache, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: Dry heaves, loose stool, headache, body aches, fever (102), chills, sore arm, inflamed/sore lymph node in right armpit, sore throat (brief), and racing heart for first day.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Palpitations, Pyrexia, Retching
Clinical narrative: Dry heaves, loose stool, headache, body aches, fever (102), chills, sore arm, inflamed/sore lymph node in right armpit, sore throat (brief), and racing heart for first day.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Severe vomiting started approximately 13 hours after shot and lasted for about 10 hours.
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Bell's palsy, Blister, Deafness, Ear pain
Clinical narrative: herpes zoster oticus/Ramsey Hunt syndrome/vesicles in right ear/vertigo/problems with balance/ear pain; vomiting; Hearing loss; Shingles; Bell's Palsy/right sided facial weakness, tingling and numbness; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or around 24-OCT-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine adult health maintenance and for its intended purpose: the prevention of shingles (dose, dose number, route, anatomical site of vaccination, lot # and expiration date were not provided). On an unknown date (reported as shortly after receiving the vaccine), the patient suffered vesicles in right ear, vomiting, vertigo, problems with balance, hearing loss, ear pain, right sided facia weakness, tingling and numbness and was diagnosed with shingles (herpes zoster), Bell's Palsy (facial paralysis), Ramsey Hunt syndrome and herpes zoster oticus (herpes zoster oticus). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. In addition, the patient sustained severe and permanent personal injuries. Further, the patient had suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Finally, as direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of Herpes zoster oticus, herpes zoster, vomiting, deafness and facial paralysis was not recovered. The causal relationship between the events and zoster vaccine live (ZOSTAVAX) was assessed as related.  Herpes zoster oticus, herpes zoster, vomiting, deafness and facial paralysis were considered disabling event by the reporter.  Upon internal review, herpes zoster oticus, deafness and facial paralysis were considered medically significant events.
Sex: M
Vaccine: VARZOS
Symptoms: Facial paresis, Herpes zoster, Herpes zoster oticus, Hypoaesthesia, Paraesthesia
Clinical narrative: herpes zoster oticus/Ramsey Hunt syndrome/vesicles in right ear/vertigo/problems with balance/ear pain; vomiting; Hearing loss; Shingles; Bell's Palsy/right sided facial weakness, tingling and numbness; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or around 24-OCT-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine adult health maintenance and for its intended purpose: the prevention of shingles (dose, dose number, route, anatomical site of vaccination, lot # and expiration date were not provided). On an unknown date (reported as shortly after receiving the vaccine), the patient suffered vesicles in right ear, vomiting, vertigo, problems with balance, hearing loss, ear pain, right sided facia weakness, tingling and numbness and was diagnosed with shingles (herpes zoster), Bell's Palsy (facial paralysis), Ramsey Hunt syndrome and herpes zoster oticus (herpes zoster oticus). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. In addition, the patient sustained severe and permanent personal injuries. Further, the patient had suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Finally, as direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of Herpes zoster oticus, herpes zoster, vomiting, deafness and facial paralysis was not recovered. The causal relationship between the events and zoster vaccine live (ZOSTAVAX) was assessed as related.  Herpes zoster oticus, herpes zoster, vomiting, deafness and facial paralysis were considered disabling event by the reporter.  Upon internal review, herpes zoster oticus, deafness and facial paralysis were considered medically significant events.
Sex: M
Vaccine: VARZOS
Symptoms: Vertigo, Vomiting
Clinical narrative: herpes zoster oticus/Ramsey Hunt syndrome/vesicles in right ear/vertigo/problems with balance/ear pain; vomiting; Hearing loss; Shingles; Bell's Palsy/right sided facial weakness, tingling and numbness; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or around 24-OCT-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine adult health maintenance and for its intended purpose: the prevention of shingles (dose, dose number, route, anatomical site of vaccination, lot # and expiration date were not provided). On an unknown date (reported as shortly after receiving the vaccine), the patient suffered vesicles in right ear, vomiting, vertigo, problems with balance, hearing loss, ear pain, right sided facia weakness, tingling and numbness and was diagnosed with shingles (herpes zoster), Bell's Palsy (facial paralysis), Ramsey Hunt syndrome and herpes zoster oticus (herpes zoster oticus). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. In addition, the patient sustained severe and permanent personal injuries. Further, the patient had suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Finally, as direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of Herpes zoster oticus, herpes zoster, vomiting, deafness and facial paralysis was not recovered. The causal relationship between the events and zoster vaccine live (ZOSTAVAX) was assessed as related.  Herpes zoster oticus, herpes zoster, vomiting, deafness and facial paralysis were considered disabling event by the reporter.  Upon internal review, herpes zoster oticus, deafness and facial paralysis were considered medically significant events.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Cardiac disorder, Deafness, Herpes zoster, Post herpetic neuralgia, Staphylococcal infection
Clinical narrative: loss of hearing; resistant staph infection; postherpetic neuralgia; vision issues; heart complications; multiple outbreaks of herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently approximately 73-year-old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 29-OCT-2012, the patient was administered the zoster vaccine live (ZOSTAVAX) (dose, dose#, route of administration and anatomical location, lot#, expiration date were not specified) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unspecified date, the patient was treated by a provider for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: multiple outbreaks of herpes zoster, postherpetic neuralgia, vision issues, loss of hearing, heart complications and resistant staphylococcus infection. The outcome of the events was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the evens of loss of hearing and resistant staphylococcus infection were determined to be medically significant.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: loss of hearing; resistant staph infection; postherpetic neuralgia; vision issues; heart complications; multiple outbreaks of herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently approximately 73-year-old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 29-OCT-2012, the patient was administered the zoster vaccine live (ZOSTAVAX) (dose, dose#, route of administration and anatomical location, lot#, expiration date were not specified) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unspecified date, the patient was treated by a provider for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: multiple outbreaks of herpes zoster, postherpetic neuralgia, vision issues, loss of hearing, heart complications and resistant staphylococcus infection. The outcome of the events was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the evens of loss of hearing and resistant staphylococcus infection were determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: 24 hour fever; chills; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a 64-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (on eyelid, forehead and scalp two years ago from the reporting date, at the age of 62 years) and eye swelling. Previously administered products included shingrix with an associated reaction of pyrexia (1st dose received on an unknown date, reference case US2021AMR039283).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced fever and chills. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever and chills were recovered/resolved.   It was unknown if the reporter considered the fever and chills to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself/himself. The patient had the old shot and she/he did not understand at first why her/his eye was so swollen. The patient got it treated fast and it was not very painful. The age at vaccination was not reported. The patient received Shingrix shot which gave her/him 24 hour fever and chills and she/he stated that it was so far so good. The follow-up would not possible, as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR039283:Same reporter
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shingles 3 months post receiving a second /  Vaccine; Shingles 3 months post receiving a second /  Vaccine; This case was reported by a consumer and described the occurrence of vaccination failure in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 3rd December 2020, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On 1st March 2021, 88 days after receiving Shingrix and unknown after receiving Shingrix, 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 Shingrix and Shingrix.  Additional details were reported as follows: This case was reported by patient herself. The age at vaccination was not reported but it could be 69 or 70 years. The patient developed shingles 3 months post receiving a second adult zoster (Shingrix) vaccine. On 1st March 2021, the patient began treatment for shingles. The reporter stated that she understands that the vaccine claims a 97 percent prevention rate. Her interest in writing was to understand under what condition and/or circumstances that she could fall in the 3 percent who are susceptible to getting shingles post vaccine and asked to provide her with any information about the conditions and/or circumstances that contribute to this outlier
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Deafness, Fatigue, Headache
Clinical narrative: Loss of hearing in both ears; Fatigue; Joint pain; Headache; A spontaneous report was received from a Healthcare Professional concerning a 24 years old male patient who received Moderna COVID-19 vaccine (mRNA-1273) and experienced fatigue, joint pain, headache and loss of hearing in both ears.  The patient's medical history was not provided. Products known to have been used by the patient were Tylenol and Ibuprofen.  On 26 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient experienced the events fatigue, joint pain and headache.   On 28 Jan 2021, the patient experienced the loss of hearing in both ears.  The patient was treated with Tylenol and Ibuprofen.  No relevant laboratory details were included.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events include fatigue, joint pain and headache were unknown. The outcome of the event loss of hearing in both ears was not recovered.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.