chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Fatigue, Feeling jittery, Pruritus
Clinical narrative: I received the second dose of the Pfizer Covid-19 vaccine on 02/26/022- had no issues besides some fatigue and joint pain. I woke up on 02/27/2022 and noticed I had hives all over my legs. I decided to go to the store to get some Benadryl and by the time I got back (about 1-2 hours) they went away, so I opted out of take the Benadryl. About 4 hours later they started to come back so I took the Benadryl and by the next morning, my entire body was covered in hives; sizes ranging from a pea to a melon. I immediately messaged my doctor and he prescribed hydroxyzine. Throughout the day (2/28/2022) my entire body was burning and itching, and I almost felt jittery. I took the hydroxyzine before bed on 2/28 and woke up in the morning with them gone. A day passed without any hives, but then on 3/2/2022 I developed the hives again into the morning of 3/3/2022. Two more days passed without the hives, and then they flared up again on 3/6/2022.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: I received the second dose of the Pfizer Covid-19 vaccine on 02/26/022- had no issues besides some fatigue and joint pain. I woke up on 02/27/2022 and noticed I had hives all over my legs. I decided to go to the store to get some Benadryl and by the time I got back (about 1-2 hours) they went away, so I opted out of take the Benadryl. About 4 hours later they started to come back so I took the Benadryl and by the next morning, my entire body was covered in hives; sizes ranging from a pea to a melon. I immediately messaged my doctor and he prescribed hydroxyzine. Throughout the day (2/28/2022) my entire body was burning and itching, and I almost felt jittery. I took the hydroxyzine before bed on 2/28 and woke up in the morning with them gone. A day passed without any hives, but then on 3/2/2022 I developed the hives again into the morning of 3/3/2022. Two more days passed without the hives, and then they flared up again on 3/6/2022.
Sex: U
Vaccine: PPV
Symptoms: Syringe issue
Clinical narrative: I was advised to contact you about an issue with Pneumovax 23 syringes administered in our clinic: Lot # UO18309, SN # 101528455965, exp date 1/8/2023. History: On X/XX/22, our XXXXXXXX medical assistant was administering a Pneumovax 23 to the patient. He pressed down on the plunger and the barrel flange shattered, cutting through the glove and removing a small chunk of skin form his left index finger near the cuticle. He unfortunately disposed of the syringe in the sharps container. There was no blood exposure to the patient. Injury was reported to practice manager.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Asthenia, Dizziness, Dysstasia, Gastrointestinal pain
Clinical narrative: Severe stomach pain Severe stomach and intestinal cramping Dizzy, nausea, vertigo, problems moving and standing Headache, weakness Prescribed Zofran anti nausea, took motrin for nerve swelling 14 days stomach pain, nausea, vertigo 3-4 days headache. Fully resolved 2 weeks
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Movement disorder, Nausea, Swelling, Vertigo
Clinical narrative: Severe stomach pain Severe stomach and intestinal cramping Dizzy, nausea, vertigo, problems moving and standing Headache, weakness Prescribed Zofran anti nausea, took motrin for nerve swelling 14 days stomach pain, nausea, vertigo 3-4 days headache. Fully resolved 2 weeks
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: General physical health deterioration, Mental impairment
Clinical narrative: Narrative: A 79yo male with PMH of Goiter Nodule, GERD, Vitamin D-Deficiency, ADHD, Sensorineural Hearing Loss of Combined Type, Cerebral Infraction due to Embolism of Middle Cerebral Artery, Depressive Disorder, Venous Insufficiency of Leg, Fall, Hyperlipidemia, Right Hemiparesis, Mild Cognitive Decline, Long -term current use of anticoagulant, Chronic A-Fib, Walking dysability, Frontal Lobe Syndrome, Malignant Neoplasm of Urinary Bladder/Papilary Urothelial Cancer, Pressure Ulcer on Sacrum, OA, Tubular Adenoma, Dysarthria, Dysphagia, AKI on CKD, DM2, Foot Gangrene, HTN, OSA, Bladder Cancer, On December 13, 2021 the attending physician reported patient declined in mental and physicial status soon after receiving covid-19 vaccine Patient's immunization record showed, he received Covid -19 vaccin In 2021 on January 14, February 4 and November 22
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypotension
Clinical narrative: Narrative:  First Shingrix vaccine given and shortly after, patient became hypotensive. Patient was given epinephrine, and transported to Hospital
Age: 74.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus
Clinical narrative: Narrative: 73yo female reported pruritus with influenza vaccine in the past to her new primary care provider when she moved. No other info available about the vaccine. Provider flagged pt's ADR in chart
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Carpal tunnel syndrome, Hypoaesthesia, Laboratory test abnormal
Clinical narrative: Narrative: Patient report: "I want to file a report with the vaccine division.  shortly after taking my second dose in march a started having numbness in my left hand and right arm. the ortho dept have attributed the right arm to my neck issues from my TBI and the left hand due to carpel tunnel from a test they performed. i  have not had the recommended surgery for my hand carpel tunnel how ever the numbness has subsided about 90% in direct correspondence with my subsequent acupuncture. in my mind from doing research to effects from the second shot there is no doubt i am having adverse reaction to that shot. i would like this documented with the CDC.  please know what steps i need to take. i am very afraid that without the acupuncture treatment i may lose the use of my hand." Medical center will work closely with patient and treatment team to ensure patient is properly treated and addressed. Actions completed: Actions: 1) Pharmacy will report to the FDA Vaccine Event Reporting System (VAER) on the patients behalf by using the Adverse Drug Event Reporting System. 2. Follow up phone call with the patient completed. The patient was very appreciative of the call and had no additional questions.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Narrative: PATIENT ADMITTED TO LOCAL HOSPITAL. CAME TO HOSPITAL REQUESTING REFILL OF APIXABAN 5/2021. THAT IS THE FIRST RECORD I SAW OF THE PE. REPORT NOT ENTTERED BY PROVIDER UNTIL 10/21. I DON'T THINK THE PATIENT INFORMED THE HOSPITAL WHAT WAS GOING ON AT THE TIME IT HAPPENED, NOR DID HE INDICATE OR KNOW IT MIGHT BE RELATED TO THE VACCINATION.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Lymph node pain, Pain assessment, Post concussion syndrome
Clinical narrative: POSSIBLE POST-CONCUSSION SYNDROME; LYMPH NODE PAIN LEFT SIDE OF BODY FOR 2 WEEKS; INJECTION SITE PAIN, LEFT ARM; 99.7 TEMPERATURE (NORMAL IS 97.5); This spontaneous report received from a patient concerned an 80 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: 24-AUG-2021) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced possible post-concussion syndrome, lymph node pain left side of body for 2 weeks, injection site pain, and 99.7 temperature (normal is 97.5). Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.7, and Pain scale (NR: not provided) 3. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lymph node pain left side of body for 2 weeks, and 99.7 temperature (normal is 97.5), and was recovering from injection site pain, and possible post-concussion syndrome. This report was non-serious.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: POSSIBLE POST-CONCUSSION SYNDROME; LYMPH NODE PAIN LEFT SIDE OF BODY FOR 2 WEEKS; INJECTION SITE PAIN, LEFT ARM; 99.7 TEMPERATURE (NORMAL IS 97.5); This spontaneous report received from a patient concerned an 80 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: 24-AUG-2021) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced possible post-concussion syndrome, lymph node pain left side of body for 2 weeks, injection site pain, and 99.7 temperature (normal is 97.5). Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.7, and Pain scale (NR: not provided) 3. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lymph node pain left side of body for 2 weeks, and 99.7 temperature (normal is 97.5), and was recovering from injection site pain, and possible post-concussion syndrome. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Immediate post-injection reaction
Clinical narrative: Immediately after the vaccine, I waited for 30 mins then went to my car and tested my blood sugar and it was extremely high. We went home and I kept taking more test and taking more insulin until it was at the normal range which is 75-110. I kept close watch on my blood sugar.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Hyperreflexia, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Myelitis transverse
Clinical narrative: Within hours of 2nd dose of vaccination, the patient had acute onset  of severe neck pain with progression to weakness as well as decreased sensation from the neck down (quadriplegia) within 2 days. When I saw the patient 7 months later, she had hyperreflexia of the arms and legs, worse in the left sided limbs, with a spinal sensory level over the upper trunk. Final clinical diagnosis was transverse myelitis related to 2nd dose of COVID19 vaccination.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Quadriplegia, Sensory level, Sensory loss
Clinical narrative: Within hours of 2nd dose of vaccination, the patient had acute onset  of severe neck pain with progression to weakness as well as decreased sensation from the neck down (quadriplegia) within 2 days. When I saw the patient 7 months later, she had hyperreflexia of the arms and legs, worse in the left sided limbs, with a spinal sensory level over the upper trunk. Final clinical diagnosis was transverse myelitis related to 2nd dose of COVID19 vaccination.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Anal fissure, Angioedema, Blood test, Body temperature increased, Cerebrovascular accident
Clinical narrative: Slightly elevated temp for 3 months, ocular pain, right side swelling, phantom urination feeling, right side pain, vomiting, dizziness/light headedness, rashes over entire body, ear pain, headaches, stroke occurance, angioadema, chest pain, shortness of breath, gastro issues, anal fissures, nerve pain. All have continued at various levels and alternating/grouped reactions at a years mark.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea, Ear pain, Eye pain
Clinical narrative: Slightly elevated temp for 3 months, ocular pain, right side swelling, phantom urination feeling, right side pain, vomiting, dizziness/light headedness, rashes over entire body, ear pain, headaches, stroke occurance, angioadema, chest pain, shortness of breath, gastro issues, anal fissures, nerve pain. All have continued at various levels and alternating/grouped reactions at a years mark.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Headache, Laboratory test, Micturition urgency, Neuralgia
Clinical narrative: Slightly elevated temp for 3 months, ocular pain, right side swelling, phantom urination feeling, right side pain, vomiting, dizziness/light headedness, rashes over entire body, ear pain, headaches, stroke occurance, angioadema, chest pain, shortness of breath, gastro issues, anal fissures, nerve pain. All have continued at various levels and alternating/grouped reactions at a years mark.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash, Swelling, Vomiting
Clinical narrative: Slightly elevated temp for 3 months, ocular pain, right side swelling, phantom urination feeling, right side pain, vomiting, dizziness/light headedness, rashes over entire body, ear pain, headaches, stroke occurance, angioadema, chest pain, shortness of breath, gastro issues, anal fissures, nerve pain. All have continued at various levels and alternating/grouped reactions at a years mark.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Aortic stenosis, Aortic valve incompetence, Arteriogram coronary normal, C-reactive protein increased, Cardiac imaging procedure abnormal
Clinical narrative: In brief, Patient is a 69 year old man referred from Facility for suspected acute myocarditis based on chest symptoms, marked elevation in troponin with global left ventricular hypokinesis but normal coronary angiography.   Regarding myocarditis, cardiac MRI at Facility was also suggestive of this diagnosis with evidence of acute edema.  He did not have features to suggest giant cell myocarditis without heart block or ventricular arrhythmias, nor was it suggestive of eosinophilic myocarditis with no circulating eosinophils nor recent drug exposures.  With conservative management he experienced marked recovery, with near normalization in cardiac troponin, and with normalization of LV systolic function by echocardiography.  He was not treated with immunosuppressive therapy, but we have advised that he not exert himself for the coming months in keeping with standard activity recommendations post myocarditis.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Echocardiogram abnormal, Left ventricular dysfunction, Left ventricular hypertrophy, Mitral valve incompetence
Clinical narrative: In brief, Patient is a 69 year old man referred from Facility for suspected acute myocarditis based on chest symptoms, marked elevation in troponin with global left ventricular hypokinesis but normal coronary angiography.   Regarding myocarditis, cardiac MRI at Facility was also suggestive of this diagnosis with evidence of acute edema.  He did not have features to suggest giant cell myocarditis without heart block or ventricular arrhythmias, nor was it suggestive of eosinophilic myocarditis with no circulating eosinophils nor recent drug exposures.  With conservative management he experienced marked recovery, with near normalization in cardiac troponin, and with normalization of LV systolic function by echocardiography.  He was not treated with immunosuppressive therapy, but we have advised that he not exert himself for the coming months in keeping with standard activity recommendations post myocarditis.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Myelopathy, Myocarditis, Oedema, Troponin increased, Ventricular hypokinesia
Clinical narrative: In brief, Patient is a 69 year old man referred from Facility for suspected acute myocarditis based on chest symptoms, marked elevation in troponin with global left ventricular hypokinesis but normal coronary angiography.   Regarding myocarditis, cardiac MRI at Facility was also suggestive of this diagnosis with evidence of acute edema.  He did not have features to suggest giant cell myocarditis without heart block or ventricular arrhythmias, nor was it suggestive of eosinophilic myocarditis with no circulating eosinophils nor recent drug exposures.  With conservative management he experienced marked recovery, with near normalization in cardiac troponin, and with normalization of LV systolic function by echocardiography.  He was not treated with immunosuppressive therapy, but we have advised that he not exert himself for the coming months in keeping with standard activity recommendations post myocarditis.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chills, Diarrhoea, Dyspnoea, Fatigue
Clinical narrative: I had high fever, chills, and fatigue that lasted from Monday thru Thursday. I took Tylenol and Advil and drank water. I rested for a couple of days and all of the symptoms subsided. After my 3rd shot (Pfizer 10-17-2021-EN6204) I started having diarrhea 3 or 4 times a week and having 4 or 5 bowel movements per day which is more than I normally would. I went to urgent care but they did not do anything to help with the issue. The issue is still ongoing and I am just dealing with it. I was also running a fever and was short of breath during the urgent care visit as well.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Frequent bowel movements, Hyperpyrexia, Pyrexia
Clinical narrative: I had high fever, chills, and fatigue that lasted from Monday thru Thursday. I took Tylenol and Advil and drank water. I rested for a couple of days and all of the symptoms subsided. After my 3rd shot (Pfizer 10-17-2021-EN6204) I started having diarrhea 3 or 4 times a week and having 4 or 5 bowel movements per day which is more than I normally would. I went to urgent care but they did not do anything to help with the issue. The issue is still ongoing and I am just dealing with it. I was also running a fever and was short of breath during the urgent care visit as well.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Biopsy skin abnormal, Dermatitis allergic, Eosinophil count, Lymphocyte count, Neutrophil count
Clinical narrative: SEVERE SKIN ALLERGICE REATION TO THE WHOLE BODY IN THE MORNING AFTER THE FIRST DOSE.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT WAS GIVEN AN EXPIRED DOSE AT TIME OF VISIT. EXPIRATION DATE WAS ON 09/21/2021.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Balance disorder, Blood test, Gait disturbance, Pain in extremity
Clinical narrative: About 15 mins after the vaccine, I had great difficulty walking. I had pain in my legs and ankles. I had to be transported by wheelchair to get into my car. The symptoms did not go away and presently, I still have issues with gate and balance. I have went to multiple doctors with no results.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Wheelchair user, X-ray
Clinical narrative: About 15 mins after the vaccine, I had great difficulty walking. I had pain in my legs and ankles. I had to be transported by wheelchair to get into my car. The symptoms did not go away and presently, I still have issues with gate and balance. I have went to multiple doctors with no results.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein increased, Cardiac imaging procedure normal, Cardiomegaly, Chest X-ray abnormal, Chest pain
Clinical narrative: Hospitalized with myocarditis. Left sided chest pain, nausea, vomiting, dyspnea.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram, Echocardiogram normal, Electrocardiogram ST segment elevation, Myocarditis
Clinical narrative: Hospitalized with myocarditis. Left sided chest pain, nausea, vomiting, dyspnea.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: N-terminal prohormone brain natriuretic peptide increased, Nausea, Scan myocardial perfusion abnormal, Scan with contrast abnormal, Troponin increased
Clinical narrative: Hospitalized with myocarditis. Left sided chest pain, nausea, vomiting, dyspnea.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Hospitalized with myocarditis. Left sided chest pain, nausea, vomiting, dyspnea.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Give at her when she was under 18 years old
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Cystitis, Death, Dementia, Hydronephrosis
Clinical narrative: Admission date 11/11/2021. HPI: Hospice admission; pt admitted to the hospital for sepsis secondary to cystitis and transitioned to hospice. Hx of hypertension, hypothyroid, rheumatoid arthritis. Allergy Hx: egg, sulfa, adhesive, erythromycin base, procaine DX: septic shock, uti, hyronephrosis, acute kidney injury, metabolic encephalopathy, dementia Comfort care measures employed. Pt passed away 11/14/2021.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic encephalopathy, Sepsis, Septic shock, Urinary tract infection
Clinical narrative: Admission date 11/11/2021. HPI: Hospice admission; pt admitted to the hospital for sepsis secondary to cystitis and transitioned to hospice. Hx of hypertension, hypothyroid, rheumatoid arthritis. Allergy Hx: egg, sulfa, adhesive, erythromycin base, procaine DX: septic shock, uti, hyronephrosis, acute kidney injury, metabolic encephalopathy, dementia Comfort care measures employed. Pt passed away 11/14/2021.
Age: 91.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Dyspnoea, Fatigue, Intensive care, Pyrexia
Clinical narrative: Patient was admitted to Hospital on 11/21/2021 to the ICU unit.  Symptoms of high fever, shortness of breath, fatigue and difficulty breathing.  Patient has a history of chronic lung disease. Patient tested positive same day for Covid. Orders was reviewed for this information that appears to be charted by hospital staff. No discharge date was given.  Unknown days of stay in hospital.
Age: 91.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient was admitted to Hospital on 11/21/2021 to the ICU unit.  Symptoms of high fever, shortness of breath, fatigue and difficulty breathing.  Patient has a history of chronic lung disease. Patient tested positive same day for Covid. Orders was reviewed for this information that appears to be charted by hospital staff. No discharge date was given.  Unknown days of stay in hospital.
Age: 91.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, Vaccine breakthrough infection
Clinical narrative: pt brought to ED with stroke-like sx, increase weakness, hypotension, increased confusion; placed on 100% NRB mask; cardiogenic shock secondary to acute heart failure in the setting of pulmonary edema; found to be positive for COVID; comfort measures; pt's condition rapidly declined and she died in the hospital
Age: 91.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, COVID-19, Cardiac failure acute, Cardiogenic shock, Confusional state
Clinical narrative: pt brought to ED with stroke-like sx, increase weakness, hypotension, increased confusion; placed on 100% NRB mask; cardiogenic shock secondary to acute heart failure in the setting of pulmonary edema; found to be positive for COVID; comfort measures; pt's condition rapidly declined and she died in the hospital
Age: 91.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, General physical health deterioration, Hypotension, Neurological symptom, Pulmonary oedema
Clinical narrative: pt brought to ED with stroke-like sx, increase weakness, hypotension, increased confusion; placed on 100% NRB mask; cardiogenic shock secondary to acute heart failure in the setting of pulmonary edema; found to be positive for COVID; comfort measures; pt's condition rapidly declined and she died in the hospital
Age: 91.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: pt brought to ED with stroke-like sx, increase weakness, hypotension, increased confusion; placed on 100% NRB mask; cardiogenic shock secondary to acute heart failure in the setting of pulmonary edema; found to be positive for COVID; comfort measures; pt's condition rapidly declined and she died in the hospital
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Attending Physician: (Privacy)   Date of Admission:  1/26/2022   Chief Complaint:  Fatigue, dyspnea   Source of Information:  Patient and Available medical record   History of Present Illness:  This is a 73y.o. female with a medical history of sarcoidosis, COPD, CVA, hypertension who presented to the emergency department secondary to increased dyspnea on exertion, fatigue, weakness. She states that she is on 2 L nasal cannula at home with exertion. She states that her dyspnea has continued to get worse over the past few months. She now admits to having increased fatigue as well. Denies any associated dizziness, chest pain, nausea, vomiting, or diarrhea. Her presentation, she was found to be hypotensive with blood pressure 90/40. Patient was found to be COVID- 19 positive.   ROS: Constitutional:  Denies fever or chills. Admits to fatigue Eyes:  Denies change in visual acuity, eye pain  HENT:  Denies nasal congestion or sore throat  Respiratory:  Denies cough. Admits to shortness of breath  Cardiovascular:  Denies chest pain or edema  GI:  Denies abdominal pain, nausea, vomiting, bloody stools or diarrhea  GU:  Denies dysuria, hematuria   Musculoskeletal:  Denies back pain. Admits to joint pain  Integument:  Denies rash, papules Neurologic:  Denies headache, focal weakness or sensory changes  Endocrine:  Denies polyuria or polydipsia  Lymphatic:  Denies tender or enlarged lymph nodes  Psychiatric:  Denies depression or anxiety
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, COVID-19, Dyspnoea, Dyspnoea exertional
Clinical narrative: Attending Physician: (Privacy)   Date of Admission:  1/26/2022   Chief Complaint:  Fatigue, dyspnea   Source of Information:  Patient and Available medical record   History of Present Illness:  This is a 73y.o. female with a medical history of sarcoidosis, COPD, CVA, hypertension who presented to the emergency department secondary to increased dyspnea on exertion, fatigue, weakness. She states that she is on 2 L nasal cannula at home with exertion. She states that her dyspnea has continued to get worse over the past few months. She now admits to having increased fatigue as well. Denies any associated dizziness, chest pain, nausea, vomiting, or diarrhea. Her presentation, she was found to be hypotensive with blood pressure 90/40. Patient was found to be COVID- 19 positive.   ROS: Constitutional:  Denies fever or chills. Admits to fatigue Eyes:  Denies change in visual acuity, eye pain  HENT:  Denies nasal congestion or sore throat  Respiratory:  Denies cough. Admits to shortness of breath  Cardiovascular:  Denies chest pain or edema  GI:  Denies abdominal pain, nausea, vomiting, bloody stools or diarrhea  GU:  Denies dysuria, hematuria   Musculoskeletal:  Denies back pain. Admits to joint pain  Integument:  Denies rash, papules Neurologic:  Denies headache, focal weakness or sensory changes  Endocrine:  Denies polyuria or polydipsia  Lymphatic:  Denies tender or enlarged lymph nodes  Psychiatric:  Denies depression or anxiety
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Hypotension, Influenza A virus test negative, Influenza B virus test, Nucleic acid test
Clinical narrative: Attending Physician: (Privacy)   Date of Admission:  1/26/2022   Chief Complaint:  Fatigue, dyspnea   Source of Information:  Patient and Available medical record   History of Present Illness:  This is a 73y.o. female with a medical history of sarcoidosis, COPD, CVA, hypertension who presented to the emergency department secondary to increased dyspnea on exertion, fatigue, weakness. She states that she is on 2 L nasal cannula at home with exertion. She states that her dyspnea has continued to get worse over the past few months. She now admits to having increased fatigue as well. Denies any associated dizziness, chest pain, nausea, vomiting, or diarrhea. Her presentation, she was found to be hypotensive with blood pressure 90/40. Patient was found to be COVID- 19 positive.   ROS: Constitutional:  Denies fever or chills. Admits to fatigue Eyes:  Denies change in visual acuity, eye pain  HENT:  Denies nasal congestion or sore throat  Respiratory:  Denies cough. Admits to shortness of breath  Cardiovascular:  Denies chest pain or edema  GI:  Denies abdominal pain, nausea, vomiting, bloody stools or diarrhea  GU:  Denies dysuria, hematuria   Musculoskeletal:  Denies back pain. Admits to joint pain  Integument:  Denies rash, papules Neurologic:  Denies headache, focal weakness or sensory changes  Endocrine:  Denies polyuria or polydipsia  Lymphatic:  Denies tender or enlarged lymph nodes  Psychiatric:  Denies depression or anxiety
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Respiratory syncytial virus test negative, SARS-CoV-2 test positive
Clinical narrative: Attending Physician: (Privacy)   Date of Admission:  1/26/2022   Chief Complaint:  Fatigue, dyspnea   Source of Information:  Patient and Available medical record   History of Present Illness:  This is a 73y.o. female with a medical history of sarcoidosis, COPD, CVA, hypertension who presented to the emergency department secondary to increased dyspnea on exertion, fatigue, weakness. She states that she is on 2 L nasal cannula at home with exertion. She states that her dyspnea has continued to get worse over the past few months. She now admits to having increased fatigue as well. Denies any associated dizziness, chest pain, nausea, vomiting, or diarrhea. Her presentation, she was found to be hypotensive with blood pressure 90/40. Patient was found to be COVID- 19 positive.   ROS: Constitutional:  Denies fever or chills. Admits to fatigue Eyes:  Denies change in visual acuity, eye pain  HENT:  Denies nasal congestion or sore throat  Respiratory:  Denies cough. Admits to shortness of breath  Cardiovascular:  Denies chest pain or edema  GI:  Denies abdominal pain, nausea, vomiting, bloody stools or diarrhea  GU:  Denies dysuria, hematuria   Musculoskeletal:  Denies back pain. Admits to joint pain  Integument:  Denies rash, papules Neurologic:  Denies headache, focal weakness or sensory changes  Endocrine:  Denies polyuria or polydipsia  Lymphatic:  Denies tender or enlarged lymph nodes  Psychiatric:  Denies depression or anxiety
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Computerised tomogram, Electroencephalogram, Loss of consciousness, Magnetic resonance imaging, Paralysis
Clinical narrative: Completely paralyzed, taken to hospital, slowly subsided; Could barely speak; This case was reported by a consumer via call center representative and described the occurrence of paralysis in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th October 2021, the patient received the 2nd dose of Shingrix. On 2nd November 2021, 3 days after receiving Shingrix, the patient experienced paralysis (serious criteria hospitalization and GSK medically significant) and speech disorder (serious criteria hospitalization). On an unknown date, the outcome of the paralysis and speech disorder were recovering/resolving.   It was unknown if the reporter considered the paralysis and speech disorder to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient became completely paralyzed from the neck down and could barely speak garbled one syllable words. The patient was taken by ambulance to the hospital. The CT (computed tomography) scan and various tests were conducted (the patient was told it was not a stroke or transient ischaemic attack (TIA)). Within 3 to 4 hours at the hospital the paralysis slowly subsided and he/she was able to speak. The patient stated that there had been some minor effects but hopefully it would all subside eventually.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Speech disorder
Clinical narrative: Completely paralyzed, taken to hospital, slowly subsided; Could barely speak; This case was reported by a consumer via call center representative and described the occurrence of paralysis in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th October 2021, the patient received the 2nd dose of Shingrix. On 2nd November 2021, 3 days after receiving Shingrix, the patient experienced paralysis (serious criteria hospitalization and GSK medically significant) and speech disorder (serious criteria hospitalization). On an unknown date, the outcome of the paralysis and speech disorder were recovering/resolving.   It was unknown if the reporter considered the paralysis and speech disorder to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient became completely paralyzed from the neck down and could barely speak garbled one syllable words. The patient was taken by ambulance to the hospital. The CT (computed tomography) scan and various tests were conducted (the patient was told it was not a stroke or transient ischaemic attack (TIA)). Within 3 to 4 hours at the hospital the paralysis slowly subsided and he/she was able to speak. The patient stated that there had been some minor effects but hopefully it would all subside eventually.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Computerised tomogram normal, Laboratory test normal, Paralysis, Speech disorder
Clinical narrative: Completely paralyzed, taken to hospital, slowly subsided; Could barely speak; This case was reported by a consumer via call center representative and described the occurrence of paralysis in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th October 2021, the patient received the 2nd dose of Shingrix. On 2nd November 2021, 3 days after receiving Shingrix, the patient experienced paralysis (serious criteria hospitalization and GSK medically significant) and speech disorder (serious criteria hospitalization). On an unknown date, the outcome of the paralysis and speech disorder were recovering/resolving.   It was unknown if the reporter considered the paralysis and speech disorder to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient became completely paralyzed from the neck down and could barely speak garbled one syllable words. The patient was taken by ambulance to the hospital. The CT (computed tomography) scan and various tests were conducted (the patient was told it was not a stroke or transient ischaemic attack (TIA)). Within 3 to 4 hours at the hospital the paralysis slowly subsided and he/she was able to speak. The patient stated that there had been some minor effects but hopefully it would all subside eventually.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19 pneumonia, Convalescent plasma transfusion, Mechanical ventilation, Respiratory failure
Clinical narrative: Hospitalized resp failure, intubated and ventilated.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Endotracheal intubation, Mechanical ventilation, Respiratory failure
Clinical narrative: Hospitalized resp failure, intubated and ventilated.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Internal haemorrhage, Ovarian cyst, Ultrasound scan vagina
Clinical narrative: In May 2021 I had an ovarian cyst rupture and bleed in my abdomen the day after I received my vaccine. In mid August 2021 I started having extreme fatigue every day for several months. Diarrhea that was either orange or green, extreme sharp stabbing pain in lower small intestines and major swelling in large intestines with pulsating sharp then dull pain on the top left where my large intestines bend down. I've had to completely stop wheat/gluten, dairy, grease, iodized salt, sugar, gassy vegetables, mushrooms, alfalfa sprouts, all fruits except strawberries and green bananas (only half). I can only eat cooked green beans, cooked spinach, and cooked Asparagus. Lettuce, 2 baby carrots, 3 slices of cucumber. If I eat something I can't my stomach does everything I've described and my mid back up to the base of my skull, shoulders, collar bones all joints in between and the muscles and tendons hurt extremely bad. January 31, 2022 I thought another cyst was going to burst. Feb 1, 2022 I went to the emergency room. I do have a cyst but its too small to hurt the way I was. Feb. 7th I went back to the ER for extreme total spine pain. I've been having that ever since. I'm going to have MRI's March 15th and 17th for my spine, neck, and left shoulder.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Bone pain, Condition aggravated, Diarrhoea
Clinical narrative: In May 2021 I had an ovarian cyst rupture and bleed in my abdomen the day after I received my vaccine. In mid August 2021 I started having extreme fatigue every day for several months. Diarrhea that was either orange or green, extreme sharp stabbing pain in lower small intestines and major swelling in large intestines with pulsating sharp then dull pain on the top left where my large intestines bend down. I've had to completely stop wheat/gluten, dairy, grease, iodized salt, sugar, gassy vegetables, mushrooms, alfalfa sprouts, all fruits except strawberries and green bananas (only half). I can only eat cooked green beans, cooked spinach, and cooked Asparagus. Lettuce, 2 baby carrots, 3 slices of cucumber. If I eat something I can't my stomach does everything I've described and my mid back up to the base of my skull, shoulders, collar bones all joints in between and the muscles and tendons hurt extremely bad. January 31, 2022 I thought another cyst was going to burst. Feb 1, 2022 I went to the emergency room. I do have a cyst but its too small to hurt the way I was. Feb. 7th I went back to the ER for extreme total spine pain. I've been having that ever since. I'm going to have MRI's March 15th and 17th for my spine, neck, and left shoulder.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Faeces discoloured, Fatigue, Gastrointestinal pain, Headache, Myalgia
Clinical narrative: In May 2021 I had an ovarian cyst rupture and bleed in my abdomen the day after I received my vaccine. In mid August 2021 I started having extreme fatigue every day for several months. Diarrhea that was either orange or green, extreme sharp stabbing pain in lower small intestines and major swelling in large intestines with pulsating sharp then dull pain on the top left where my large intestines bend down. I've had to completely stop wheat/gluten, dairy, grease, iodized salt, sugar, gassy vegetables, mushrooms, alfalfa sprouts, all fruits except strawberries and green bananas (only half). I can only eat cooked green beans, cooked spinach, and cooked Asparagus. Lettuce, 2 baby carrots, 3 slices of cucumber. If I eat something I can't my stomach does everything I've described and my mid back up to the base of my skull, shoulders, collar bones all joints in between and the muscles and tendons hurt extremely bad. January 31, 2022 I thought another cyst was going to burst. Feb 1, 2022 I went to the emergency room. I do have a cyst but its too small to hurt the way I was. Feb. 7th I went back to the ER for extreme total spine pain. I've been having that ever since. I'm going to have MRI's March 15th and 17th for my spine, neck, and left shoulder.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ovarian cyst ruptured, Pain, Spinal pain, Swelling, Tendon pain
Clinical narrative: In May 2021 I had an ovarian cyst rupture and bleed in my abdomen the day after I received my vaccine. In mid August 2021 I started having extreme fatigue every day for several months. Diarrhea that was either orange or green, extreme sharp stabbing pain in lower small intestines and major swelling in large intestines with pulsating sharp then dull pain on the top left where my large intestines bend down. I've had to completely stop wheat/gluten, dairy, grease, iodized salt, sugar, gassy vegetables, mushrooms, alfalfa sprouts, all fruits except strawberries and green bananas (only half). I can only eat cooked green beans, cooked spinach, and cooked Asparagus. Lettuce, 2 baby carrots, 3 slices of cucumber. If I eat something I can't my stomach does everything I've described and my mid back up to the base of my skull, shoulders, collar bones all joints in between and the muscles and tendons hurt extremely bad. January 31, 2022 I thought another cyst was going to burst. Feb 1, 2022 I went to the emergency room. I do have a cyst but its too small to hurt the way I was. Feb. 7th I went back to the ER for extreme total spine pain. I've been having that ever since. I'm going to have MRI's March 15th and 17th for my spine, neck, and left shoulder.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Incorrect route of product administration, Injection site granuloma, Injection site haemorrhage, Pyogenic granuloma, Skin lesion
Clinical narrative: Error: Wrong Route (SC, IM, etc.)-
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood blister, Injection site bruising
Clinical narrative: Error: Wrong Route (SC, IM, etc.)-
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Error: Wrong Route (SC, IM, etc.)-
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody positive, Arthralgia, C-reactive protein increased, Joint swelling, Nodule
Clinical narrative: Acute left thumb pain, joint swelling and tenderness with palpable nodule. Ongoing over the course of 10 days requiring treatment with NSAIDS and steroids.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, X-ray abnormal
Clinical narrative: Acute left thumb pain, joint swelling and tenderness with palpable nodule. Ongoing over the course of 10 days requiring treatment with NSAIDS and steroids.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Deep vein thrombosis
Clinical narrative: pt admit with COVID 2/22/22 s/p 2 doses Pfizer (4/8/21 & 4/29/21, no booster). pt ended up w/ DVT that was likely COVID related
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: "The vaccine this patient received was determined to have had a temperature excursion below the recommended storage temperature prior to administration. There was no guidance to repeat the dose from the vaccine manufacturer."
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: "The vaccine this patient received was determined to have had a temperature excursion below the recommended storage temperature prior to administration. There was no guidance to repeat the dose from the vaccine manufacturer."
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: "The vaccine this patient received was determined to have had a temperature excursion below the recommended storage temperature prior to administration. There was no guidance to repeat the dose from the vaccine manufacturer."
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: High heart rate for 3 days. My normal heart rate is around 55 - 60. Around 17:00 on the first night, it spiked to 140. It took about 3 days for it to return to normal.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: "The vaccine this patient received was determined to have had a temperature excursion below the recommended storage temperature prior to administration. There was no guidance to repeat the dose from the vaccine manufacturer."
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: The vaccine received, determined to have a temperature excursion below the recommended storage temperature prior to administration. There was no guidance to repeat the dose from the manufacturer.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: "The vaccine this patient received was determined to have had a temperature excursion below the recommended storage temperature prior to administration. There was no guidance to repeat the dose from the vaccine manufacturer."
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: "The vaccine this patient received was determined to have had a temperature excursion below the recommended storage temperature prior to administration. There was no guidance to repeat the dose from the vaccine manufacturer."
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: "The vaccine this patient received was determined to have had a temperature excursion below the recommended storage temperature prior to administration. There was no guidance to repeat the dose from the vaccine manufacturer."
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: "The vaccine this patient received was determined to have had a temperature excursion below the recommended storage temperature prior to administration. There was no guidance to repeat the dose from the vaccine manufacturer."
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: "The vaccine this patient received was determined to have had a temperature excursion below the recommended storage temperature prior to administration. There was no guidance to repeat the dose from the vaccine manufacturer."
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: "The vaccine this patient received was determined to have had a temperature excursion below the recommended storage temperature prior to administration. There was no guidance to repeat the dose from the vaccine manufacturer."
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hordeolum
Clinical narrative: A stye developed in my left eye the evening of my vaccination.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Biopsy, Influenza like illness, Rash
Clinical narrative: Felt like she had the flu; After the Booster dose the rash got much worse; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like she had the flu), RASH (After the Booster dose the rash got much worse) and ARTHRALGIA (Joint pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Knee operation. Concurrent medical conditions included Drug allergy (Promethazine, Betadine and Lovenox), Psoriatic arthritis, May-Thurner syndrome, Burning mouth syndrome, Hypothyroidism, Migraine and Immunocompromised. Concomitant products included BUPROPION for Anxiety, CLONAZEPAM for Burning mouth syndrome, METFORMIN for Digestion impaired, ATORVASTATIN for Hyperlipidemia, TOPIRAMATE for Migraine, OMEPRAZOLE for Stomach discomfort, LEVOTHYROXINE for an unknown indication.    On 25-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like she had the flu), RASH (After the Booster dose the rash got much worse) and ARTHRALGIA (Joint pain). At the time of the report, INFLUENZA LIKE ILLNESS (Felt like she had the flu) and ARTHRALGIA (Joint pain) had resolved and RASH (After the Booster dose the rash got much worse) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: negative (Negative) Negative: They couldn't detect what it was..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient is 5' 7" tall. Concomitant medication included Policarpine 5mg 3/4 times a day for Dry Mouth.  Patient did not tested positive for Covid-19 and she did not receive any other vaccine within 1 month prior to Moderna Covid-19 vaccine. Vaccine gave her a rash since day 1 and never went away.   Patient's chronic illnesses did not improve or worsening after the vaccination. Her Dermatologist took a biopsy and in the results, they couldn't detect what it was. Patient did not experience a similar event on the past. Only the rash was ongoing. Patient reported that she was a swimmer and that she was embarrassed to go the pool to swim.   No treatment information were provided.   This case was linked to MOD-2022-503106, MOD-2022-503094, MOD-2022-503108 (Patient Link).