chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Acute myocardial infarction, Angiogram pulmonary normal, Catheterisation cardiac normal, Chest pain, Dyspnoea exertional
Clinical narrative: Several days after vaccine administration on 12/05/23, he developed body aching, Fatigue, dyspnea on exertion. On 12/11/2023 in evening - he had onset of chest pain. He was admitted to hospital on 12/12/23 - 12/14/23 Presented to ER 12/12/2023 with chest pain diaphoresis and dyspnea on exertion. The initial Troponin I high sensivity value was 2,981 repeat Troponin was 3974. Cardiac catheterization 12/12/2023 showed normal left main and normal LAD and minimal luminal irregularities of left circumflex and right coronary artery - LV ejection fraction estimate = 60%. EKG 12/12/2023 = sinus rhythm with nonspecific T wave flattening. No significant change compared to 2014 EKG ECHOcardiogram 12/13/2023: Left ventricle normal systolic function low normal with EF 50-55% CTA thorax 12/12/2023 = normal. No CT evidence of thoracic aortic aneurysm or dissection. The discharge diagnosis was acute non ST segment myocardial infarction - he was started on Lisinopril, atorvastatin, Aspirin and clopidogrel. I think he had acute myocarditis due to the COVID vaccine.
Age: 45.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Echocardiogram normal, Ejection fraction normal, Electrocardiogram T wave amplitude decreased, Fatigue, Hyperhidrosis
Clinical narrative: Several days after vaccine administration on 12/05/23, he developed body aching, Fatigue, dyspnea on exertion. On 12/11/2023 in evening - he had onset of chest pain. He was admitted to hospital on 12/12/23 - 12/14/23 Presented to ER 12/12/2023 with chest pain diaphoresis and dyspnea on exertion. The initial Troponin I high sensivity value was 2,981 repeat Troponin was 3974. Cardiac catheterization 12/12/2023 showed normal left main and normal LAD and minimal luminal irregularities of left circumflex and right coronary artery - LV ejection fraction estimate = 60%. EKG 12/12/2023 = sinus rhythm with nonspecific T wave flattening. No significant change compared to 2014 EKG ECHOcardiogram 12/13/2023: Left ventricle normal systolic function low normal with EF 50-55% CTA thorax 12/12/2023 = normal. No CT evidence of thoracic aortic aneurysm or dissection. The discharge diagnosis was acute non ST segment myocardial infarction - he was started on Lisinopril, atorvastatin, Aspirin and clopidogrel. I think he had acute myocarditis due to the COVID vaccine.
Age: 45.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Pain, Sinus rhythm, Troponin, Troponin I increased
Clinical narrative: Several days after vaccine administration on 12/05/23, he developed body aching, Fatigue, dyspnea on exertion. On 12/11/2023 in evening - he had onset of chest pain. He was admitted to hospital on 12/12/23 - 12/14/23 Presented to ER 12/12/2023 with chest pain diaphoresis and dyspnea on exertion. The initial Troponin I high sensivity value was 2,981 repeat Troponin was 3974. Cardiac catheterization 12/12/2023 showed normal left main and normal LAD and minimal luminal irregularities of left circumflex and right coronary artery - LV ejection fraction estimate = 60%. EKG 12/12/2023 = sinus rhythm with nonspecific T wave flattening. No significant change compared to 2014 EKG ECHOcardiogram 12/13/2023: Left ventricle normal systolic function low normal with EF 50-55% CTA thorax 12/12/2023 = normal. No CT evidence of thoracic aortic aneurysm or dissection. The discharge diagnosis was acute non ST segment myocardial infarction - he was started on Lisinopril, atorvastatin, Aspirin and clopidogrel. I think he had acute myocarditis due to the COVID vaccine.
Age: 0.58
Sex: F
Vaccine: UNK
Symptoms: Underdose
Clinical narrative: While pulling the vaccine I realized I was pulling 0.5 mL syringe, the doctor ordered 1 mL. I thought there was an error with the ordering process, and I asked a coworker to message the immunization specialist to aware her of the issue and went to give the vaccine to the child. The vaccine specialist replied stated 1 mL was the correct dosage child should've received due to their weight and the child should come back in office before the day ends to receive the other half dose to equal out 1 mL. When I went back to the exam room the mother was gone. I called mothers phone number on file multiple times and left voicemails explaining the situation and to call back asap. A letter was sent to her home stating incident.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Incorrect route of product administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Vaccine given Sub Q instead of IM. Pt has redness, pain & swelling of Elbow right below injection sight.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Joint swelling
Clinical narrative: Vaccine given Sub Q instead of IM. Pt has redness, pain & swelling of Elbow right below injection sight.
Age: 4.0
Sex: M
Vaccine: FLU4, FLU4, FLU4, FLU4, FLU4, FLU4
Symptoms: Injection site swelling, Product administered at inappropriate site
Clinical narrative: Patient came in for a flu vaccination, after given immunization the patients arm swelled. Parents took child to doctors, doctor said vaccination was given to low on the arm. Advised parents to given benadryl and ice the arm until swelling goes down and to follow up if not.
Age: 58.0
Sex: M
Vaccine: UNK
Symptoms: Alopecia, Asthma, Disability, Dyspnoea, Fall
Clinical narrative: I was fine. Had covid and never missed a day of work. I was born on a military base and wanted to return and visit my sister. Had to have vacine to travel. I got it. Months later my health failed. I now have ashma. My lungs barely function. I cant breath. My doc i forms me u cant get asthma. U are born with it. Well pulminary expert says i have it. My hair is falling out. I tire very easily and once fell getting out of bed. Layed on floor for 6 hours as i couldnt move and no one was home.
Age: 58.0
Sex: M
Vaccine: UNK
Symptoms: Fatigue, General physical health deterioration, Housebound, Impaired work ability, Lung disorder
Clinical narrative: I was fine. Had covid and never missed a day of work. I was born on a military base and wanted to return and visit my sister. Had to have vacine to travel. I got it. Months later my health failed. I now have ashma. My lungs barely function. I cant breath. My doc i forms me u cant get asthma. U are born with it. Well pulminary expert says i have it. My hair is falling out. I tire very easily and once fell getting out of bed. Layed on floor for 6 hours as i couldnt move and no one was home.
Age: 58.0
Sex: M
Vaccine: UNK
Symptoms: Mobility decreased, Pulmonary function test decreased, Quality of life decreased
Clinical narrative: I was fine. Had covid and never missed a day of work. I was born on a military base and wanted to return and visit my sister. Had to have vacine to travel. I got it. Months later my health failed. I now have ashma. My lungs barely function. I cant breath. My doc i forms me u cant get asthma. U are born with it. Well pulminary expert says i have it. My hair is falling out. I tire very easily and once fell getting out of bed. Layed on floor for 6 hours as i couldnt move and no one was home.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Atrial fibrillation, Cardioversion
Clinical narrative: First time persistent a-fib
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Headache, Injection site swelling, Injection site warmth, Lymphadenopathy, Malaise
Clinical narrative: 36 hours post vaccine, injection site swelling with warmth, down to elbow still occuring                                                              Malaise for last 4 days                                                                                                                                                                                             Headache for 4 days since injection, relieved in part by naproxen. On Day 4, swollen gland/lymph node under right ear began.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash
Clinical narrative: Red rash on chest and legs
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Patient returned about 1.5 hours after her vaccine and stated she felt lightheaded. She denied shortness of breath, lip/tongue/throat itching and tingling. She denied chest pain, palpations, throat closing sensation.  Epi pen was not deemed clinically necessary. Patient was directed to lay on exam table. 911 was called and came to evaluate patient. She signed the EMS refusal form and left the clinic stating she was feeling better. She stated she had not slept well the night prior and had not drank much water during the day.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Musculoskeletal stiffness, Paraesthesia, Peripheral swelling
Clinical narrative: PATIENT COMPLAINS OF TIGHTNESS IN ARM, DIFFICULTY RAISING ARM, SWELLING, TINGLING SENSATION
Age: 43.0
Sex: F
Vaccine: PNC20
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Patient was vaccinated in right deltoid at approximately 10:20am and she came back to the counter at 10:55am stating that her right leg was numb.  She said that it happened right away as she walked down the dairy aisle.  She said it was only slightly tingly and she could walk fine.  I looked at the vaccination site (right ARM) and there was nothing out of the ordinary.   I suggested patient call her primary care doctor for advice.  I checked in with patient later in the day 3:55pm and she said her doctor referred her to the emergency room and they told her that it did not seem dangerous.  She said she was home and resting.
Age: 41.0
Sex: F
Vaccine: HPV9
Symptoms: Dehydration, Dyspnoea, Feeding disorder, Headache, Hyperhidrosis
Clinical narrative: Woke up 8 hours after shot with body aches, muscle cramps, muscle spasms, high fever, heavy sweating, unable to stay awake, passing out fainting, and inability to consume food or liquids. Laid in bed for 48 hours, sweating profusely, soaking my bed, linens and everything else with high fever. Head pain, headache, Severe dehydration even when trying to hydrate. Lost feeling in hands (numb, tingling feelings). Whole body aches still. All flu-like symptoms. Trouble breathing Severe shortness of breath when moving.
Age: 41.0
Sex: F
Vaccine: HPV9
Symptoms: Hypoaesthesia, Influenza like illness, Loss of consciousness, Mobility decreased, Muscle spasms
Clinical narrative: Woke up 8 hours after shot with body aches, muscle cramps, muscle spasms, high fever, heavy sweating, unable to stay awake, passing out fainting, and inability to consume food or liquids. Laid in bed for 48 hours, sweating profusely, soaking my bed, linens and everything else with high fever. Head pain, headache, Severe dehydration even when trying to hydrate. Lost feeling in hands (numb, tingling feelings). Whole body aches still. All flu-like symptoms. Trouble breathing Severe shortness of breath when moving.
Age: 41.0
Sex: F
Vaccine: HPV9
Symptoms: Pain, Paraesthesia, Pyrexia, Somnolence
Clinical narrative: Woke up 8 hours after shot with body aches, muscle cramps, muscle spasms, high fever, heavy sweating, unable to stay awake, passing out fainting, and inability to consume food or liquids. Laid in bed for 48 hours, sweating profusely, soaking my bed, linens and everything else with high fever. Head pain, headache, Severe dehydration even when trying to hydrate. Lost feeling in hands (numb, tingling feelings). Whole body aches still. All flu-like symptoms. Trouble breathing Severe shortness of breath when moving.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Full blood count, Metabolic function test, Palpitations
Clinical narrative: palpitations with heart rate over 100 bpm (nonexertional) happens several times daily since vaccine administration
Age: 74.0
Sex: M
Vaccine: RSV
Symptoms: Local reaction
Clinical narrative: Patient had an adverse reaction in right arm needing treatment by a Methylprednisolone Dosepack which he filled 1/7/24.
Age: 16.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Eye movement disorder, Loss of consciousness, Muscle spasms, Pallor
Clinical narrative: I gave a Flu shot and the Pfizer vaccine was the second shot that day. After the second vaccine his eyes rolled in the back of his head, he was very pale and his body started spasming. He woke up within 30 seconds and he laid on the floor with his feet elevated because he was light headed and dizzy. Father stated he had not eaten yet that day so I got him an orange juice. After that he was felt well enough to go home with his Father.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Cough, Erythema
Clinical narrative: The patient received a flu shot.  After 30-40 minutes later, she started dry coughing and her face turned red.  She took one tablet of Benadryl 25mg and it relieved her symptoms.  She went to the urgent care just in case.  She said the urgent care provider gave her 50mg Prednisone.  She said she was okay after the treatment but the provider advised her to go to the hospital emergency room just to be on the safe side.   She received one dose of Benadryl liquid in the ambulance on the way to the emergency room.  She received EpiPen treatment at the emergency room. She discharged from the emergency room after she monitored couple more hours.  She said she is okay now.  The emergency room provider prescribed Epipen and Prednisone 20mg for her.  She said she will pick the medication tomorrow because the provider prescribed it for future episode prevention.
Age: 69.0
Sex: M
Vaccine: FLUC4
Symptoms: Wrong product administered
Clinical narrative: Patient received flucelvax instead of Fluzone Highdose
Age: 74.0
Sex: F
Vaccine: COVID19, FLUA4, RSV
Symptoms: Asthenia, Dizziness, Myalgia
Clinical narrative: Extreme muscle pain, weakness, dizziness @ 7 hours lasted 32 hours
Sex: F
Vaccine: RSV
Symptoms: Erythema, Injection site erythema, Malaise, Pyrexia
Clinical narrative: patient had redness at injection site fever ,malaise, redness on cheek, patient is not feeling well overall since last 3 days
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Swelling face
Clinical narrative: Patient complained of swollen face/lips 3 hours after vaccine. Took Benadryl
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling cold, Feeling hot, Sleep disorder
Clinical narrative: Uncontrollable shivering, coldness, exhausted.Unable to give the time course, because I went to bed, and fell asleep.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Thirst
Clinical narrative: Uncontrollable shivering, coldness, exhausted.Unable to give the time course, because I went to bed, and fell asleep.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Swelling
Clinical narrative: Patient experienced mild swelling and redness. No itchiness or soreness. Treatment included cephalexin 500 mg, 1 capsule by mouth four times a day for 7 days.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Dyskinesia, Dyspnoea, Muscle contracture, Muscle spasms
Clinical narrative: Dismissed a L leg cramp while in bed at 9:00pm; fell asleep and was awakened by severe R leg cramps that would not abate while in bed. Got up, swung legs over bedside- L leg contractured into a position I couldn't straighten out so I went to stand up on L leg to relieve the cramping. I immediately  began to feel as though I was going to pass out. I leaned on the side of the bed, placed head in between took my legs to prevent passing out. Took several deep breathes- told myself to keep breathing- walked to living room sat on side of love seat and it wouldn't abate. Repeated placing my head in between my knees again. Became SOB; returned to bed room still deep breathing as much as possible. Grabbed cell phone and went into a 30-60 seconds jerking , shaking type spastic movements prior to landing on all fours onto carpet  and seeing that circle of light that I've experienced prior to passing out before under other circumstances as a child (getting the wind knocked out of you). I never lost consciousness. I couldn't work up any saliva, but managed to dial a friend. When he answered-all I kept saying to him was "just talk, I don't care what you're saying just talk". I had flight or flight & needed BRP's quickly. He remained on the phone until I could get the gatoraid I had in the frig . I felt better after drinking approx 6 oz. I got evaluated by local EMS, but didn't want to go to ED. No further repeat incidences have occured.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sleep disorder, Tremor
Clinical narrative: Dismissed a L leg cramp while in bed at 9:00pm; fell asleep and was awakened by severe R leg cramps that would not abate while in bed. Got up, swung legs over bedside- L leg contractured into a position I couldn't straighten out so I went to stand up on L leg to relieve the cramping. I immediately  began to feel as though I was going to pass out. I leaned on the side of the bed, placed head in between took my legs to prevent passing out. Took several deep breathes- told myself to keep breathing- walked to living room sat on side of love seat and it wouldn't abate. Repeated placing my head in between my knees again. Became SOB; returned to bed room still deep breathing as much as possible. Grabbed cell phone and went into a 30-60 seconds jerking , shaking type spastic movements prior to landing on all fours onto carpet  and seeing that circle of light that I've experienced prior to passing out before under other circumstances as a child (getting the wind knocked out of you). I never lost consciousness. I couldn't work up any saliva, but managed to dial a friend. When he answered-all I kept saying to him was "just talk, I don't care what you're saying just talk". I had flight or flight & needed BRP's quickly. He remained on the phone until I could get the gatoraid I had in the frig . I felt better after drinking approx 6 oz. I got evaluated by local EMS, but didn't want to go to ED. No further repeat incidences have occured.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Cheilitis, Dermatitis allergic, Erythema, Rash
Clinical narrative: The allergic reaction started with rash on hands and feet, and later on lower lip . Hands and feet were bright red. it started   at 4pm
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Albumin urine, Creatinine urine, Magnetic resonance imaging, X-ray limb
Clinical narrative: Physical therapy MRI and Steroid shots
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Axillary pain, Back pain, Breast swelling, Pain in extremity, Painful respiration
Clinical narrative: 11/3: Patient woke up with left breast swollen and painful on left side. By mid-day, she reported severe pain in left side of back. As the day progressed, the swelling in the breast decreased. She took 200 mg ibuprofen at 8 pm. 11/4: When she woke up, the left side of her back hurt even more, but the breast swelling was gone. 11/5: Woke up with "extreme pain in left axillary area." Also reported discomfort when taking a deep breath. 11/6: Patient had appointment with general practitioner who ruled out any cardiopulmonary issues and cancer. Symptoms were attributed to the RSV vaccine. Doctor increased ibuprofen regimen to 3 tablets (600 mg total) by mouth three times a day. 11/7: Woke up with achy hands and severe pain on left side of back, but reported symptom improvement throughout the day. 11/8: "I decreased ibuprofen to 400 mg" frequency not specified.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Headache, Wheezing
Clinical narrative: headache within 5-10 minutes after vaccine gave ice pack. pt stated trouble breathing with wheezing and cough offered to call ambulance pt refused and decided to go home and have her friend whom is a nurse look her over
Age: 60.0
Sex: M
Vaccine: COVID19, PNC20
Symptoms: Chills, Mobility decreased, Sleep disorder
Clinical narrative: Awoke middle of night with chills?. Spent all day Friday in bed? seems better on Sunday
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Hypotension, Influenza like illness, Multiple organ dysfunction syndrome
Clinical narrative: 12/12 flu like symptoms, 12/13 severe hypotension and multi system organ failure. 12/14 death
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Computerised tomogram head, Dizziness, Electrocardiogram, Full blood count
Clinical narrative: Vaccine administered at 12pm on 12/22/23- no immediate adverse events. Chills started at 11pm on day of vaccine administration. At 5:30am the following day, nausea, vomiting, and syncopal event. Then with ongoing nausea, vomiting, dizziness, with another syncopal event at 7:30am. Required evaluation in ER. No underlying history of syncope or cardiac or respiratory issues. Had 1 episode of syncope in the past with prior COVID vaccine. Ongoing tinnitus since vaccine.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Nausea, Syncope, Tinnitus, Troponin
Clinical narrative: Vaccine administered at 12pm on 12/22/23- no immediate adverse events. Chills started at 11pm on day of vaccine administration. At 5:30am the following day, nausea, vomiting, and syncopal event. Then with ongoing nausea, vomiting, dizziness, with another syncopal event at 7:30am. Required evaluation in ER. No underlying history of syncope or cardiac or respiratory issues. Had 1 episode of syncope in the past with prior COVID vaccine. Ongoing tinnitus since vaccine.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vaccine administered at 12pm on 12/22/23- no immediate adverse events. Chills started at 11pm on day of vaccine administration. At 5:30am the following day, nausea, vomiting, and syncopal event. Then with ongoing nausea, vomiting, dizziness, with another syncopal event at 7:30am. Required evaluation in ER. No underlying history of syncope or cardiac or respiratory issues. Had 1 episode of syncope in the past with prior COVID vaccine. Ongoing tinnitus since vaccine.
Age: 61.0
Sex: F
Vaccine: COVID19-2, RSV
Symptoms: Erythema, Immunisation reaction, Peripheral swelling, Pruritus
Clinical narrative: ARM WITH AREXVY IS STILL RED SORE ITCHY AND SWOLLEN AFTER OVER A WEEK. COVID ARM CLEARED UP BUT AREXVY ARM STILL SYMPTOMATIC. PT SAID IT WAS LOOKING BETTER BUT THEN FLARED UP AGAIN, STILL ITCHY AND RED. TOLD PT  STILL IN RANGE OF NORMAL, TO ICE IT, TRY CORTISONE CREAM AND BENADRYL. TOLD TO CONSULT WITH MD IF BOTHERSOME
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Dyspnoea, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Began with body chills in the evening/bedtime. This was followed by high fevers and shortness of breath and positive COVID (home test). These symptoms lasted approximately 10 days.
Age: 31.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Syncope
Clinical narrative: Pt was first given the MMR II vaccine in the left arm as an IM dose. Upon completion of second vaccine (Varivax subcutateous in posterior left arm) pt fainted in the seated position for about 10-15 seconds. When she regained consciousness she was oriented to her whereabouts and given water. She stayed in the immunization room for about 15-20 minutes at times lying on the floor at her request. We then asked that she stay in the store for an additional 10 minutes as she walked around to be sure she was no longer affected. She stated that this happens every time she gets vaccines.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Appendicitis, Blood test, Computerised tomogram, Decreased appetite
Clinical narrative: Started with abdominal pain, then low grade fever (100.4 F) and sharper abdominal pains, fever and pain coming and going, loss of appetite.  Was referred to GO specialist and diagnosed with appendicitis.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Surgery
Clinical narrative: Started with abdominal pain, then low grade fever (100.4 F) and sharper abdominal pains, fever and pain coming and going, loss of appetite.  Was referred to GO specialist and diagnosed with appendicitis.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Fatigue, Influenza like illness, Injection site erythema, Myalgia
Clinical narrative: During the night, my muscles and joints began to ache, quite badly.  When I awakened in the morning, I felt as if I had the flu - achy all over.  I was tired and slept much of the day . . . aspirin and Tylenol helped.  My arm had a four inch red circle around the injection spot, and my arm hurt very badly. Sunday morning I was better but my muscles were still very sore and I was very tired.  I took more Tylenol, and by about 2:00 in the afternoon I felt better, though my arm is still very sore.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Pain, Pain in extremity, Somnolence
Clinical narrative: During the night, my muscles and joints began to ache, quite badly.  When I awakened in the morning, I felt as if I had the flu - achy all over.  I was tired and slept much of the day . . . aspirin and Tylenol helped.  My arm had a four inch red circle around the injection spot, and my arm hurt very badly. Sunday morning I was better but my muscles were still very sore and I was very tired.  I took more Tylenol, and by about 2:00 in the afternoon I felt better, though my arm is still very sore.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Atrial fibrillation, Echocardiogram normal
Clinical narrative: New onset Atrial Fibrillation.  Has happened a handful of times since initial episode, which required an overnight hospital stay.  Have had to start seeing a cardiologist and begin taking Carvedilol.  Echocardiogram indicated no abnormal results.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Acupuncture, Anxiety, Arthralgia, Asthenia, Chills
Clinical narrative: I had my second Gardisol vaccine shot in 02/02/2018 and that day at 10pm I had an Adverse reaction:  felt hot, had a fever of 99, experienced tachycardia, joint pain,  headache, chills, sweats, felt weak, and felt a poor energy. I went to the emergency room around midnight when I was experiencing these symptoms. I saw a neurologist, 1st visit was 09/19/2018 and a rheumatologist, 1st visit was 01/31/2019 and their Outcome and impression after evaluating me was chronic fatigue syndrome  and fibromyalgia. Treatment since second vaccine has been Acupuncture, Psychology, and vitamins such as D and B.  I continue to experience to this day beginning the new year of 2024 from the adverse reaction to the Gardisol vaccine is chronic fatigue, fibromyalgia, clouded memory, tachycardia, anxiety, and headaches. Since the adverse reaction in 2018, I have been receiving academic accommodations through the disability services at my schools.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Chronic fatigue syndrome, Educational problem, Feeling hot, Fibromyalgia, Headache
Clinical narrative: I had my second Gardisol vaccine shot in 02/02/2018 and that day at 10pm I had an Adverse reaction:  felt hot, had a fever of 99, experienced tachycardia, joint pain,  headache, chills, sweats, felt weak, and felt a poor energy. I went to the emergency room around midnight when I was experiencing these symptoms. I saw a neurologist, 1st visit was 09/19/2018 and a rheumatologist, 1st visit was 01/31/2019 and their Outcome and impression after evaluating me was chronic fatigue syndrome  and fibromyalgia. Treatment since second vaccine has been Acupuncture, Psychology, and vitamins such as D and B.  I continue to experience to this day beginning the new year of 2024 from the adverse reaction to the Gardisol vaccine is chronic fatigue, fibromyalgia, clouded memory, tachycardia, anxiety, and headaches. Since the adverse reaction in 2018, I have been receiving academic accommodations through the disability services at my schools.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Hyperhidrosis, Magnetic resonance imaging head, Memory impairment, Neuropsychological test, Tachycardia
Clinical narrative: I had my second Gardisol vaccine shot in 02/02/2018 and that day at 10pm I had an Adverse reaction:  felt hot, had a fever of 99, experienced tachycardia, joint pain,  headache, chills, sweats, felt weak, and felt a poor energy. I went to the emergency room around midnight when I was experiencing these symptoms. I saw a neurologist, 1st visit was 09/19/2018 and a rheumatologist, 1st visit was 01/31/2019 and their Outcome and impression after evaluating me was chronic fatigue syndrome  and fibromyalgia. Treatment since second vaccine has been Acupuncture, Psychology, and vitamins such as D and B.  I continue to experience to this day beginning the new year of 2024 from the adverse reaction to the Gardisol vaccine is chronic fatigue, fibromyalgia, clouded memory, tachycardia, anxiety, and headaches. Since the adverse reaction in 2018, I have been receiving academic accommodations through the disability services at my schools.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Hypoaesthesia, Hypoaesthesia oral, Migraine
Clinical narrative: About 30 mins after the first vaccine I had tingling / numbness around the whole of my mouth and extreme dizziness requiring to get out of the carb. This happened with each of my vaccines , but sooner each time and longer each time. For the last 2 years I have had ongoing numbness and tingling in my legs, daily migraines for some time, needing medication and ongoing dizziness
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: About 30 mins after the first vaccine I had tingling / numbness around the whole of my mouth and extreme dizziness requiring to get out of the carb. This happened with each of my vaccines , but sooner each time and longer each time. For the last 2 years I have had ongoing numbness and tingling in my legs, daily migraines for some time, needing medication and ongoing dizziness
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient had NO adverse events.  The patient received this vaccine in error.  He received the spikevax moderna covid vaccine mistakenly on January 5, 2024.  He had already gotten the comirnaty pfizer vaccine in September of 2023.  Thus it was a therapy duplication which does not meet the CDC current guidelines.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Peripheral coldness, Tremor
Clinical narrative: 1 Hour after shot I began feeling cold hands and feet. 9hours after shot I took blood pressure meds and within 5-10minutes I felt extremely cold and began violently shaking all over with hands shaking back and forth about 6inches each direction. Got in bed under pre heated electric blanket and it took over 2 hours to stop shaking but still felt very cold all over. Never experienced these symptoms before! Certain the reaction was blood pressure meds with the covid shot!  My cousin's husband in a different state experienced the EXACT SYMPTOMS and was also on blood pressure medication! WARNING--This is a DANGER especially to older  people who are on blood pressure medication!!
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nasal congestion, SARS-CoV-2 test, Sneezing, Throat irritation
Clinical narrative: Sneezing, stuffy head, scratchy throat
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No reports of adverse effects; HCP called for TE evaluation of VARIVAX and PROQUAD / TE occurred in August and 1 of each vaccine was administered prior to November; This spontaneous report has been received from a medical assistant, concerning an unspecified number of patients of unknown ages and genders.  The patients' medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  In August 2023, doses of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number W022294 was verified to be valid, expiration date reported and confirmed as 13-JUL-2024); and measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant human albumin) (PROQUAD) (lot number W016360 was verified to be valid, expiration date reported and confirmed as 16-NOV-2023) suffered a temperature excursion (TE). On an unspecified date in 2023 (reported as "prior to November"), 1 dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number W022294, expiration date 13-JUL-2024); and 1 dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (PROQUAD) (lot number W016360, expiration date 16-NOV-2023) were administered to the patients as prophylaxis (exact doses, routes of administration, and anatomical locations were not provided) (Product storage error).  There was no reports of adverse effects. Limited information was provided.  Follow up information has been received from the medical assistant on 29-DEC-2023. This case was considered to be non-valid, however, upon receipt of follow up information it is now considered valid as the patient's demographics were reported. The patient was confirmed to be a 1-year-old female patient. Varicella virus vaccine live (oka/merck) (VARIVAX) was administered by the medical assistant on 13-OCT-2023, subcutaneously in the right thigh. The medical assistant was trained for vaccine administration. The patient was vaccinated with public funds at a private doctor's office. The temperature excursion was identified by digital data logger. The medical assistant was clearing the ice build up from the freezer, as a result the temperature was too warm. There was a maximum temperature of over 22.3 Fahrenheit degrees. It was warm for 28 minutes. The vaccine was left on hold until they found out it was stable and could still be used. The patient's response was good. Vaccination was continued on 06-DEC-2023. The patient's response was good. The vaccine was available for return or evaluation.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: HBP called on behalf of an HCP to ask about possible inadvertent administration of 2 pediatric doses of RECOMBIVAX HB to an adult, and the potential need for revaccination.  Request case 02522847.   HBP refused to provide any additional information f; No additional AE/No PQC; This spontaneous report has been received from a Health care business professional (HBP) and refers to an adult patient of unknown age and gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not provided.  On an unknown date, the patient was inadvertently vaccinated with 2 pediatric doses of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 5/0.5 microgram per milliliter (mcg/mL) intramuscular injection (product administered to patient of inappropriate age), at a dose of 0.5 milliliter (mL), administered as prophylaxis (dosage regimen, vaccination scheme, lot #, expiry date, anatomical site of administration and route of administration were not provided). No additional adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The nurse is reporting that a patient received improperly stored vaccine; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 29-DEC-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # X018730 exp date 06-JAN-2025) (dose and route not reported). The temperature of excursion was 17.2 F for a time frame of 50 minutes. There was no previous temperature of excursion. No adverse events were reported.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, COVID-19, COVID-19 immunisation
Clinical narrative: RE-VACCINATION WITH DIFFERENT COVID-19 VACCINE.; REBOUND COVID; This spontaneous report received from a patient by a Business partner on 08-DEC-2023 was received on 08-DEC-2023 and concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: anxiety, overweight, chronic pain, and covid-19. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number: 1809029) dose was not reported, administered on 12-MAR-2021 to Left Arm for covid-19 prophylaxis. Non-company suspect vaccine included: elasomeran (Dose number in series 2) (batch number: 037F21A, form of admin, route of admin, and were not reported) dose was not reported, administered on 21-DEC-2021 to Left Arm for an unspecified indication. ; and tozinameran (Dose number in series 3) (batch number: GH9693, form of admin, route of admin, and were not reported) dose was not reported, administered on 04-OCT-2022 to Left Arm for an unspecified indication. No concomitant medications were reported. On 22-NOV-2023, treatment medications included: nirmatrelvir/ritonavir. On 01-DEC-2023, the patient experienced rebound covid. On an unspecified date, the patient experienced re-vaccination with different covid-19 vaccine. Laboratory data (dates unspecified) included: Body temperature 100.4. The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, and tozinameran was not applicable. The patient had not recovered from rebound covid, and the outcome of re-vaccination with different covid-19 vaccine. was not reported. This report was non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Abdominal pain, Chills, Diarrhoea, Myalgia, Pyrexia
Clinical narrative: diarrhea; abdominal cramping; fever; chills; muscle aches; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), ABDOMINAL PAIN (abdominal cramping), PYREXIA (fever), CHILLS (chills) and MYALGIA (muscle aches) in a 36-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    Concurrent medical conditions included Asthma.   On 29-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 29-Dec-2023, the patient experienced DIARRHOEA (diarrhea), ABDOMINAL PAIN (abdominal cramping), PYREXIA (fever), CHILLS (chills), MYALGIA (muscle aches) and VACCINATION SITE PAIN (injection site pain). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Fever, at a dose of every 4-6 hours and PARACETAMOL (TYLENOL) for Fever, at a dose of every 4-6 hours. At the time of the report, DIARRHOEA (diarrhea), ABDOMINAL PAIN (abdominal cramping), PYREXIA (fever), CHILLS (chills), MYALGIA (muscle aches) and VACCINATION SITE PAIN (injection site pain) had not resolved.            No concomitant medications were reported.  It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available.
Age: 36.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Vaccination site pain
Clinical narrative: diarrhea; abdominal cramping; fever; chills; muscle aches; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), ABDOMINAL PAIN (abdominal cramping), PYREXIA (fever), CHILLS (chills) and MYALGIA (muscle aches) in a 36-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    Concurrent medical conditions included Asthma.   On 29-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 29-Dec-2023, the patient experienced DIARRHOEA (diarrhea), ABDOMINAL PAIN (abdominal cramping), PYREXIA (fever), CHILLS (chills), MYALGIA (muscle aches) and VACCINATION SITE PAIN (injection site pain). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Fever, at a dose of every 4-6 hours and PARACETAMOL (TYLENOL) for Fever, at a dose of every 4-6 hours. At the time of the report, DIARRHOEA (diarrhea), ABDOMINAL PAIN (abdominal cramping), PYREXIA (fever), CHILLS (chills), MYALGIA (muscle aches) and VACCINATION SITE PAIN (injection site pain) had not resolved.            No concomitant medications were reported.  It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available.
Age: 0.08
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong patient received product
Clinical narrative: FLUZONE QIV administered to 1 month old child,with no reported adverse event; Initial information was received on 29-Dec-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 months old male patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-Dec-2023, the patient received a dose of 0.5 ml of suspect INFLUENZA QUADRIVAL A-B VACCINE (Suspension for injection) (lot UT8038KA ,Expiry date: 30-Jun-2024,strength was unknown) via intramuscular route in the left vastus lateralis for Prophylactic vaccination (Immunization) (product administered to patient of inappropriate age) (latency : same day).  Reportedly "Nurse reported 4 week old was administered FLUZONE QUADRIVALENT PFS. The first name was the same for two patients and led to confusion between the patients. When the first name was called the 1 month old went back with medical assistant instead of the 10 month old patient who was to be administered the the Fluzone Quadrivalent injection. The date of birth was confirmed, however, the 1 month old was still given the Fluzone Quadrivalent injection.   Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) was not applicable.  At time of reporting, the outcome was Unknown for the event fluzone qiv administered to 1 month old child,with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: TYP
Symptoms: Incorrect dose administered, No adverse event, Product distribution issue
Clinical narrative: the vaccines were shipped on 19Dec2023 and arrived on 26Dec2023, were supposedly sent an email stating that there has been a delay in shipping and the that the vaccines were already outside of the viability with no reported advers event; administration of a vaccine that has experienced temperature excursion that exceeded the stability data documented with no reported adverse event; Initial information received on 03-Jan-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2024SA005247(CLUSTER).  This case involves an 2 patients of unknown age/gender patient who were administered with TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] that were shipped on 19dec2023 and arrived on 26dec2023, were supposedly sent an email stating that there has been a delay in shipping and the that the vaccines were already outside of the viability with no reported advers event and administration of a vaccine that has experienced temperature excursion that exceeded the stability data documented with no reported adverse event.   On an unknown date, the patient received a dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE, Solution for injection (lot V2A121M) (dose, strength, and expiry date: unknown) vaccines were shipped on 19dec2023 and arrived on 26dec2023, were supposedly sent an email stating that there has been a delay in shipping and the that the vaccines were already outside of the viability with no reported adverse event (product storage error) via unknown route in unknown administration site for immunization.  On an unknown date the both patients administered vaccine that has experienced temperature excursion that exceeded the stability data documented with no reported adverse event (poor quality product administered) (latency same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a Covid Moderna vaccine on 12/26.  The vaccine was deemed expired by x4d per due to it being pulled out of the freezer x30d prior.  Reached out to provider for next steps.  Pending response from Moderna.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/no PQC; MMR II which expired on 12/16/2023 was inadvertently administered on 12/19/2023; This spontaneous report has been received from a medical assistant and refers to a patient of unknown age and gender.  The patient's pertinent medical history, prior drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 19-DEC-2023, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (expired product administered) (lot number U039906 has been determined to be valid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), expiration date reported and validated as 16-DEC-2023, therapy type: recombinant human albumin (rHA)), administered for prophylaxis (strength, dosage regimen, vaccination scheme, anatomical site of administration and route of administration were not provided). No additional adverse events were reported.
Sex: F
Vaccine: RAB
Symptoms: Headache, Muscular weakness
Clinical narrative: muscle weakness; headaches on and off on the top part of her head, severe headaches on the crown; Initial information received from country on 04-Jan-2024 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who had headaches on and off on the top part of her head, severe headaches on the crown and muscle weakness after receiving RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 27-Dec-2023, the patient received dose 1 of suspect RABIES (HDC) VACCINE, Powder and solvent for suspension for injection via unknown route in the right arm, she also had the immunoglobulin injected one in each leg on that day and 30-Dec-2023 she also received dose 2 of the same vaccine via unknown route in the left arm for immunization (strength, dose, batch number and expiry date- unknown). Information on the batch number was requested.  On 30-Dec-2023 the patient had headaches on and off on the top part of her head, severe headaches on the crown (headache) and muscle weakness (muscular weakness) (latency same day).  Reportedly, headaches on and off on the top part of her head, severe headaches on the crown, like "pounding real hard". The headaches lasted for a day or two, intermittently, especially when she lays down and she is relaxed. The people in the hospital told her that she should just take an aspirin.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  Outcome was Recovered / Resolved on an unknown date for the events