chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Chest pain, Electrocardiogram, Fatigue, Magnetic resonance imaging head
Clinical narrative: Heart Palpitations: Days 2 - approximately day 21 and intermittent for 90 days+; most consistent and severe for first 14 days after injection.   Chest Pain: Days 2 - present day 07/30/2021; became more severe after exercise    Tingling (Pins/Needles) in hands, feet, tongue and lips: Intermittent from Day 3 - 98 days after injection; very minor intermittent tingling after 98 days.    Burning Skin mainly head and neck: 4 - 21 days after injection   Blood Pressure Increase: systolic blood pressure increase up to 180.  My normal systolic blood pressure is around 120.  Severe blood pressure increase started to subside approximately 28 days after injection and episodes became intermittent.   Severe Throbbing/Pulsating sensations behind eyes and sinuses: approximately 3 days after injection site until approximately 84 days after injection.  Most severe the first 21 days after injection.  Vision Disturbances: approximately 2 days after injection until approximately 84 days after injection.  Vision has improved and disturbances were most severe up until approximately 84 days after injection.  Vision disturbances included: blurry vision, light sensitivity, eye floaters, tunnel vision.    Severe Fatigue and weakness: 2 hours after injection - until approximately  84 days after injection. Extreme fatigue and weakness for at least 28 days after injection.    Nausea: 2 hours after injection until approximately 14 days after injection.    Mild fever: Mild fever less than 100 F between Day 2 - 5.    Purple/Red lesions on the roof of mouth on Day 84 after injection until approximately day 92 after injection.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Oral disorder, Palpitations, Paraesthesia, Paraesthesia oral
Clinical narrative: Heart Palpitations: Days 2 - approximately day 21 and intermittent for 90 days+; most consistent and severe for first 14 days after injection.   Chest Pain: Days 2 - present day 07/30/2021; became more severe after exercise    Tingling (Pins/Needles) in hands, feet, tongue and lips: Intermittent from Day 3 - 98 days after injection; very minor intermittent tingling after 98 days.    Burning Skin mainly head and neck: 4 - 21 days after injection   Blood Pressure Increase: systolic blood pressure increase up to 180.  My normal systolic blood pressure is around 120.  Severe blood pressure increase started to subside approximately 28 days after injection and episodes became intermittent.   Severe Throbbing/Pulsating sensations behind eyes and sinuses: approximately 3 days after injection site until approximately 84 days after injection.  Most severe the first 21 days after injection.  Vision Disturbances: approximately 2 days after injection until approximately 84 days after injection.  Vision has improved and disturbances were most severe up until approximately 84 days after injection.  Vision disturbances included: blurry vision, light sensitivity, eye floaters, tunnel vision.    Severe Fatigue and weakness: 2 hours after injection - until approximately  84 days after injection. Extreme fatigue and weakness for at least 28 days after injection.    Nausea: 2 hours after injection until approximately 14 days after injection.    Mild fever: Mild fever less than 100 F between Day 2 - 5.    Purple/Red lesions on the roof of mouth on Day 84 after injection until approximately day 92 after injection.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Photophobia, Pyrexia, Skin burning sensation, Tunnel vision, Vision blurred
Clinical narrative: Heart Palpitations: Days 2 - approximately day 21 and intermittent for 90 days+; most consistent and severe for first 14 days after injection.   Chest Pain: Days 2 - present day 07/30/2021; became more severe after exercise    Tingling (Pins/Needles) in hands, feet, tongue and lips: Intermittent from Day 3 - 98 days after injection; very minor intermittent tingling after 98 days.    Burning Skin mainly head and neck: 4 - 21 days after injection   Blood Pressure Increase: systolic blood pressure increase up to 180.  My normal systolic blood pressure is around 120.  Severe blood pressure increase started to subside approximately 28 days after injection and episodes became intermittent.   Severe Throbbing/Pulsating sensations behind eyes and sinuses: approximately 3 days after injection site until approximately 84 days after injection.  Most severe the first 21 days after injection.  Vision Disturbances: approximately 2 days after injection until approximately 84 days after injection.  Vision has improved and disturbances were most severe up until approximately 84 days after injection.  Vision disturbances included: blurry vision, light sensitivity, eye floaters, tunnel vision.    Severe Fatigue and weakness: 2 hours after injection - until approximately  84 days after injection. Extreme fatigue and weakness for at least 28 days after injection.    Nausea: 2 hours after injection until approximately 14 days after injection.    Mild fever: Mild fever less than 100 F between Day 2 - 5.    Purple/Red lesions on the roof of mouth on Day 84 after injection until approximately day 92 after injection.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vitreous floaters
Clinical narrative: Heart Palpitations: Days 2 - approximately day 21 and intermittent for 90 days+; most consistent and severe for first 14 days after injection.   Chest Pain: Days 2 - present day 07/30/2021; became more severe after exercise    Tingling (Pins/Needles) in hands, feet, tongue and lips: Intermittent from Day 3 - 98 days after injection; very minor intermittent tingling after 98 days.    Burning Skin mainly head and neck: 4 - 21 days after injection   Blood Pressure Increase: systolic blood pressure increase up to 180.  My normal systolic blood pressure is around 120.  Severe blood pressure increase started to subside approximately 28 days after injection and episodes became intermittent.   Severe Throbbing/Pulsating sensations behind eyes and sinuses: approximately 3 days after injection site until approximately 84 days after injection.  Most severe the first 21 days after injection.  Vision Disturbances: approximately 2 days after injection until approximately 84 days after injection.  Vision has improved and disturbances were most severe up until approximately 84 days after injection.  Vision disturbances included: blurry vision, light sensitivity, eye floaters, tunnel vision.    Severe Fatigue and weakness: 2 hours after injection - until approximately  84 days after injection. Extreme fatigue and weakness for at least 28 days after injection.    Nausea: 2 hours after injection until approximately 14 days after injection.    Mild fever: Mild fever less than 100 F between Day 2 - 5.    Purple/Red lesions on the roof of mouth on Day 84 after injection until approximately day 92 after injection.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Myocarditis, Tachycardia, Troponin increased
Clinical narrative: Myocarditis (HCC) Tachycardia Headache Shortness of Breath
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Headache, Heart rate increased, Tachycardia
Clinical narrative: Myocarditis (HCC) Tachycardia Headache Shortness of Breath
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: Myocarditis (HCC) Tachycardia Headache Shortness of Breath
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Full blood count abnormal, Headache, Myocarditis, Pancytopenia
Clinical narrative: Myocarditis (HCC) Tachycardia Headache Shortness of Breath
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tachycardia, Troponin increased
Clinical narrative: Myocarditis (HCC) Tachycardia Headache Shortness of Breath
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Chest discomfort, Chest pain, Dysphagia, Dyspnoea
Clinical narrative: About 20 to 30 seconds after receiving  the vaccine.  My head felt very hot and heavy.  like a balloon it felt like it wanted to pop.  Then my neck felt it was be squeezed and I had hives on my neck.  The pharmacist gave me a shot of Epipen in my left thigh and 911 was called to take me to the hospital.  I was taken to medical facility.  they gave me Pepcid, Solumedrol and Benadryl.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Hyperhidrosis, Paraesthesia, Tachycardia, Throat tightness
Clinical narrative: About 20 to 30 seconds after receiving  the vaccine.  My head felt very hot and heavy.  like a balloon it felt like it wanted to pop.  Then my neck felt it was be squeezed and I had hives on my neck.  The pharmacist gave me a shot of Epipen in my left thigh and 911 was called to take me to the hospital.  I was taken to medical facility.  they gave me Pepcid, Solumedrol and Benadryl.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Feeling hot, Head discomfort, Urticaria
Clinical narrative: About 20 to 30 seconds after receiving  the vaccine.  My head felt very hot and heavy.  like a balloon it felt like it wanted to pop.  Then my neck felt it was be squeezed and I had hives on my neck.  The pharmacist gave me a shot of Epipen in my left thigh and 911 was called to take me to the hospital.  I was taken to medical facility.  they gave me Pepcid, Solumedrol and Benadryl.
Age: 94.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Atrial fibrillation, Blood culture negative, Blood lactate dehydrogenase normal, Brain natriuretic peptide increased
Clinical narrative: Fully vaccinated patient contracted COVID. Date of positivity was 7/28/2021. Patient admitted to hospital on 7/28/2021 with compliants of generalized weakness, shortness of breath, and body aches. While in the hospital, patient managed with steroids, aspirin, zinc, vitamin D, vitamin C, and prn tessalon perles. Oxygen requirements were room air - 3L (normally uses CPAP at night with 3L oxygen).
Age: 94.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: C-reactive protein normal, COVID-19, Condition aggravated, Cough, Fibrin D dimer
Clinical narrative: Fully vaccinated patient contracted COVID. Date of positivity was 7/28/2021. Patient admitted to hospital on 7/28/2021 with compliants of generalized weakness, shortness of breath, and body aches. While in the hospital, patient managed with steroids, aspirin, zinc, vitamin D, vitamin C, and prn tessalon perles. Oxygen requirements were room air - 3L (normally uses CPAP at night with 3L oxygen).
Age: 94.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, SARS-CoV-2 test positive, Streptococcus test negative, Troponin, White blood cell count decreased
Clinical narrative: Fully vaccinated patient contracted COVID. Date of positivity was 7/28/2021. Patient admitted to hospital on 7/28/2021 with compliants of generalized weakness, shortness of breath, and body aches. While in the hospital, patient managed with steroids, aspirin, zinc, vitamin D, vitamin C, and prn tessalon perles. Oxygen requirements were room air - 3L (normally uses CPAP at night with 3L oxygen).
Age: 94.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, COVID-19, Dyspnoea, Pain, SARS-CoV-2 test positive
Clinical narrative: Fully vaccinated patient contracted COVID. Date of positivity was 7/28/2021. Patient admitted to hospital on 7/28/2021 with compliants of generalized weakness, shortness of breath, and body aches. While in the hospital, patient managed with steroids, aspirin, zinc, vitamin D, vitamin C, and prn tessalon perles. Oxygen requirements were room air - 3L (normally uses CPAP at night with 3L oxygen).
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Basophil count decreased, Chest X-ray normal, Chest discomfort, Chest pain, Differential white blood cell count
Clinical narrative: This is a 16-year-old male who presents for evaluation of chest pain.  On initial presentation, the patient is comfortable in no acute distress.  Vital signs are within normal limits.  On my exam, lungs are clear to auscultation bilaterally.  I do not appreciate any murmurs or rubs on cardiac exam.  He has full and equal pulses in all extremities and no lower extremity edema.  He has no signs of infection.  Given his history of recent COVID vaccination and diffuse ST elevation on EKG, this is concerning for myocarditis versus pericarditis.  EKG was performed here and still shows diffuse ST elevation but no reciprocal depressions and the ST elevation has decreased since previous EKG done earlier today.  Did speak with Cardiology who requested that we obtain a troponin and a BNP.  Troponin came back at 2672 and BNP was normal.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Electrocardiogram ST segment elevation, Eosinophil count decreased, Fatigue, Full blood count
Clinical narrative: This is a 16-year-old male who presents for evaluation of chest pain.  On initial presentation, the patient is comfortable in no acute distress.  Vital signs are within normal limits.  On my exam, lungs are clear to auscultation bilaterally.  I do not appreciate any murmurs or rubs on cardiac exam.  He has full and equal pulses in all extremities and no lower extremity edema.  He has no signs of infection.  Given his history of recent COVID vaccination and diffuse ST elevation on EKG, this is concerning for myocarditis versus pericarditis.  EKG was performed here and still shows diffuse ST elevation but no reciprocal depressions and the ST elevation has decreased since previous EKG done earlier today.  Did speak with Cardiology who requested that we obtain a troponin and a BNP.  Troponin came back at 2672 and BNP was normal.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Haematocrit normal, Haemoglobin normal, Lymphocyte count, Mean cell haemoglobin concentration increased, Mean cell volume normal
Clinical narrative: This is a 16-year-old male who presents for evaluation of chest pain.  On initial presentation, the patient is comfortable in no acute distress.  Vital signs are within normal limits.  On my exam, lungs are clear to auscultation bilaterally.  I do not appreciate any murmurs or rubs on cardiac exam.  He has full and equal pulses in all extremities and no lower extremity edema.  He has no signs of infection.  Given his history of recent COVID vaccination and diffuse ST elevation on EKG, this is concerning for myocarditis versus pericarditis.  EKG was performed here and still shows diffuse ST elevation but no reciprocal depressions and the ST elevation has decreased since previous EKG done earlier today.  Did speak with Cardiology who requested that we obtain a troponin and a BNP.  Troponin came back at 2672 and BNP was normal.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Monocyte count decreased, Myalgia, Neutrophil count, Oropharyngeal pain, Pain
Clinical narrative: This is a 16-year-old male who presents for evaluation of chest pain.  On initial presentation, the patient is comfortable in no acute distress.  Vital signs are within normal limits.  On my exam, lungs are clear to auscultation bilaterally.  I do not appreciate any murmurs or rubs on cardiac exam.  He has full and equal pulses in all extremities and no lower extremity edema.  He has no signs of infection.  Given his history of recent COVID vaccination and diffuse ST elevation on EKG, this is concerning for myocarditis versus pericarditis.  EKG was performed here and still shows diffuse ST elevation but no reciprocal depressions and the ST elevation has decreased since previous EKG done earlier today.  Did speak with Cardiology who requested that we obtain a troponin and a BNP.  Troponin came back at 2672 and BNP was normal.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in jaw, Painful respiration, Platelet count normal, Red blood cell count normal, Red cell distribution width normal
Clinical narrative: This is a 16-year-old male who presents for evaluation of chest pain.  On initial presentation, the patient is comfortable in no acute distress.  Vital signs are within normal limits.  On my exam, lungs are clear to auscultation bilaterally.  I do not appreciate any murmurs or rubs on cardiac exam.  He has full and equal pulses in all extremities and no lower extremity edema.  He has no signs of infection.  Given his history of recent COVID vaccination and diffuse ST elevation on EKG, this is concerning for myocarditis versus pericarditis.  EKG was performed here and still shows diffuse ST elevation but no reciprocal depressions and the ST elevation has decreased since previous EKG done earlier today.  Did speak with Cardiology who requested that we obtain a troponin and a BNP.  Troponin came back at 2672 and BNP was normal.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin I increased, White blood cell count normal
Clinical narrative: This is a 16-year-old male who presents for evaluation of chest pain.  On initial presentation, the patient is comfortable in no acute distress.  Vital signs are within normal limits.  On my exam, lungs are clear to auscultation bilaterally.  I do not appreciate any murmurs or rubs on cardiac exam.  He has full and equal pulses in all extremities and no lower extremity edema.  He has no signs of infection.  Given his history of recent COVID vaccination and diffuse ST elevation on EKG, this is concerning for myocarditis versus pericarditis.  EKG was performed here and still shows diffuse ST elevation but no reciprocal depressions and the ST elevation has decreased since previous EKG done earlier today.  Did speak with Cardiology who requested that we obtain a troponin and a BNP.  Troponin came back at 2672 and BNP was normal.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood culture, Brain natriuretic peptide normal, C-reactive protein, Chest pain, Echocardiogram normal
Clinical narrative: This is a 16-year-old male who presents for evaluation of chest pain.  On initial presentation, the patient is comfortable in no acute distress.  Vital signs are within normal limits.  On my exam, lungs are clear to auscultation bilaterally.  I do not appreciate any murmurs or rubs on cardiac exam.  He has full and equal pulses in all extremities and no lower extremity edema.  He has no signs of infection.  Given his history of recent COVID vaccination and diffuse ST elevation on EKG, this is concerning for myocarditis versus pericarditis.  EKG was performed here and still shows diffuse ST elevation but no reciprocal depressions and the ST elevation has decreased since previous EKG done earlier today.  Did speak with Cardiology who requested that we obtain a troponin and a BNP.  Troponin came back at 2672 and BNP was normal.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram ST segment elevation, Red blood cell sedimentation rate, Troponin increased, Ultrasound Doppler normal
Clinical narrative: This is a 16-year-old male who presents for evaluation of chest pain.  On initial presentation, the patient is comfortable in no acute distress.  Vital signs are within normal limits.  On my exam, lungs are clear to auscultation bilaterally.  I do not appreciate any murmurs or rubs on cardiac exam.  He has full and equal pulses in all extremities and no lower extremity edema.  He has no signs of infection.  Given his history of recent COVID vaccination and diffuse ST elevation on EKG, this is concerning for myocarditis versus pericarditis.  EKG was performed here and still shows diffuse ST elevation but no reciprocal depressions and the ST elevation has decreased since previous EKG done earlier today.  Did speak with Cardiology who requested that we obtain a troponin and a BNP.  Troponin came back at 2672 and BNP was normal.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye discharge, Headache, Injection site pain, Lacrimation increased
Clinical narrative: SKIN HURTS; CHILLS AND FEEL COLD; HEADACHE; FEELS LIKE THE VACCINE ESCALATED HER TUMOUR; VISION ISSUE; MUCUS FROM HER EYES; TEARING UP/ NOT ABLE TO READ; SITE OF INJECTION PAIN; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included anxiety, and tumour, and other pre-existing medical conditions included patient reported that had undergone 28 radiations because she was not able to do surgery. The patient had a tumour, which was located in the eyes/nose region.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, and expiry: unknown) dose was not reported, frequency one total, administered on the left deltoid on 23-JUL-2021 for prophylactic vaccination. She took anti-convulsion medication because she thought she was going to have convulsion. Patient took anti anxiety medicine for anxiety. For the headache she had been using cold compress.  On 23-JUL-2021, the patient experienced site of injection pain. On 24-JUL-2021, the patient experienced vision issue, mucus from her eyes, feels like the vaccine escalated her tumour, tearing up/ not able to read, feel cold, chills and headache. On an unspecified date, the patient experienced skin hurts. All the symptoms that started on the day of report occurred at 10:30 am when she woke up. The patient informed of not having any symptoms from her tumour prior to the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, chills, site of injection pain, vision issue, and feel cold, and the outcome of skin hurts, mucus from her eyes, feels like the vaccine escalated her tumour and tearing up/ not able to read were not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210753058-covid-19 vaccine ad26.cov2.s-feels like the vaccine escalated her tumour. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Tumour flare, Visual impairment
Clinical narrative: SKIN HURTS; CHILLS AND FEEL COLD; HEADACHE; FEELS LIKE THE VACCINE ESCALATED HER TUMOUR; VISION ISSUE; MUCUS FROM HER EYES; TEARING UP/ NOT ABLE TO READ; SITE OF INJECTION PAIN; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included anxiety, and tumour, and other pre-existing medical conditions included patient reported that had undergone 28 radiations because she was not able to do surgery. The patient had a tumour, which was located in the eyes/nose region.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, and expiry: unknown) dose was not reported, frequency one total, administered on the left deltoid on 23-JUL-2021 for prophylactic vaccination. She took anti-convulsion medication because she thought she was going to have convulsion. Patient took anti anxiety medicine for anxiety. For the headache she had been using cold compress.  On 23-JUL-2021, the patient experienced site of injection pain. On 24-JUL-2021, the patient experienced vision issue, mucus from her eyes, feels like the vaccine escalated her tumour, tearing up/ not able to read, feel cold, chills and headache. On an unspecified date, the patient experienced skin hurts. All the symptoms that started on the day of report occurred at 10:30 am when she woke up. The patient informed of not having any symptoms from her tumour prior to the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, chills, site of injection pain, vision issue, and feel cold, and the outcome of skin hurts, mucus from her eyes, feels like the vaccine escalated her tumour and tearing up/ not able to read were not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210753058-covid-19 vaccine ad26.cov2.s-feels like the vaccine escalated her tumour. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Essential tremor, Injection site cellulitis, Injection site pruritus, Injection site reaction, Nausea
Clinical narrative: Injection site reaction, itching at injection site, cellulitis at injection site that increased in size daily from 3/15/2021-3/19/2021.  Low grade fever, nausea.  Developed shaky hands and legs during same timeframe.  Essential tremors still exist and are still present.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor, Ultrasound scan abnormal
Clinical narrative: Injection site reaction, itching at injection site, cellulitis at injection site that increased in size daily from 3/15/2021-3/19/2021.  Low grade fever, nausea.  Developed shaky hands and legs during same timeframe.  Essential tremors still exist and are still present.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Chills, Fatigue, Gait disturbance
Clinical narrative: Middle of the night fever, chills, body ache, headache, fatigue. 28 hours later only thing remaining was joint pain. After a couple weeks with lingering multiple joint pain went to ortho Dr. After trying chiropractic and massage and pain relievers.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Magnetic resonance imaging abnormal, Magnetic resonance imaging joint, Meniscus cyst, Meniscus injury
Clinical narrative: Middle of the night fever, chills, body ache, headache, fatigue. 28 hours later only thing remaining was joint pain. After a couple weeks with lingering multiple joint pain went to ortho Dr. After trying chiropractic and massage and pain relievers.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Tendonitis, X-ray limb abnormal
Clinical narrative: Middle of the night fever, chills, body ache, headache, fatigue. 28 hours later only thing remaining was joint pain. After a couple weeks with lingering multiple joint pain went to ortho Dr. After trying chiropractic and massage and pain relievers.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray abnormal, Lymphadenopathy, Pneumonitis, Pneumothorax, Rash
Clinical narrative: Lymph nodes swelling, inflammation lung, collaped lung, rash on face
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Neutropenia, Neutrophil count decreased, Platelet count decreased, Pyrexia, White blood cell count decreased
Clinical narrative: Two weeks after the first Pfizer COVID vaccine shot, developed severe neutropenia (ANC = 0.62 and WBC = 3.24). Follow up with hematologist four weeks after first shot and neutropenia were worsened (ANC = 0.49 and WBC = 2.65). No treatment was admitted and follow fever protocol and visit the hematologist after 6 more weeks. Hematologist also called off second Pfizer shot.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Disturbance in attention, Fatigue, Feeling abnormal, Headache
Clinical narrative: First shot instant headache for a day. Then for the  next 30 days felt like I was in a complete fog can't focus felt completely out of it and exhausted. Second shot left arm shoulder an my neck were so sore I couldn't turn my head for two days. It's  been since May with the first shot . I'm still feel like I'm in a fog absolutely exhausted and still can't keep focused.  Unfortunately it's effecting my job performance.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immediate post-injection reaction, Impaired work ability, Mobility decreased, Neck pain, Pain in extremity
Clinical narrative: First shot instant headache for a day. Then for the  next 30 days felt like I was in a complete fog can't focus felt completely out of it and exhausted. Second shot left arm shoulder an my neck were so sore I couldn't turn my head for two days. It's  been since May with the first shot . I'm still feel like I'm in a fog absolutely exhausted and still can't keep focused.  Unfortunately it's effecting my job performance.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Bell's palsy, Eyelid ptosis, Facial paralysis, Facial paresis
Clinical narrative: Diagnosed with Bell's Palsy.  My face paralyzed and droops on the left side .  My eye, mouth, and all facial muscles on the left side are weak and won't move.  My tongue felt numb and and I have no sense of taste. I have a hard time talking because the left side of my mouth doesn't move.  My eye is watering a lot and I can't shut my left eyelid all the way.  I have headaches and jaw pain.  I went to the ER and then to my primary doctor and was given an antiviral medicine and prednisone. I am still currently having all of these symptoms and the jaw pain is worse.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia oral, Lacrimation increased, Pain in jaw, Speech disorder
Clinical narrative: Diagnosed with Bell's Palsy.  My face paralyzed and droops on the left side .  My eye, mouth, and all facial muscles on the left side are weak and won't move.  My tongue felt numb and and I have no sense of taste. I have a hard time talking because the left side of my mouth doesn't move.  My eye is watering a lot and I can't shut my left eyelid all the way.  I have headaches and jaw pain.  I went to the ER and then to my primary doctor and was given an antiviral medicine and prednisone. I am still currently having all of these symptoms and the jaw pain is worse.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Chest pain, Dyspnoea, Troponin increased
Clinical narrative: presented to ED with SOB and substernal chest pain 30 min after vaccne.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase normal, Chest pain, Computerised tomogram thorax normal, Echocardiogram normal, Electrocardiogram normal
Clinical narrative: Acute onset chest pain at 1230 in the morning the day after vaccine (approx 16 hours later) with elevated troponin in clinic.  Sent to ER.  Normal EKG.  Nml CK.   Repeat troponin more elevated.  Patient improved with toradol IM x1, with resolution of symptoms within 24 hours.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin increased
Clinical narrative: Acute onset chest pain at 1230 in the morning the day after vaccine (approx 16 hours later) with elevated troponin in clinic.  Sent to ER.  Normal EKG.  Nml CK.   Repeat troponin more elevated.  Patient improved with toradol IM x1, with resolution of symptoms within 24 hours.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Amaurosis fugax, Blood test, C-reactive protein increased, Echocardiogram normal, Electrocardiogram ambulatory normal
Clinical narrative: 3/8/2021 Experienced Amaurosis Fugax, over 50% of sight impacted in left eye for 6+ hours. Saw Optometrist on 3/9.  Dr diagnosed the Amaurosis Fugax and referred me to GP / Cardiology to investigate TIA. 3/25 debilitating headache.  Sent from Urgent Care to E.R. with elevated blood pressure and excessive headache pain
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Headache, Scan with contrast normal, Ultrasound Doppler
Clinical narrative: 3/8/2021 Experienced Amaurosis Fugax, over 50% of sight impacted in left eye for 6+ hours. Saw Optometrist on 3/9.  Dr diagnosed the Amaurosis Fugax and referred me to GP / Cardiology to investigate TIA. 3/25 debilitating headache.  Sent from Urgent Care to E.R. with elevated blood pressure and excessive headache pain
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram abnormal, Lithotripsy, Nephrolithiasis, Stent placement, Urinary system X-ray
Clinical narrative: Obstructed kidney stone causing 4 day hospitalization,  stent placement,  2 lithotripsies.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Blood test normal, Borrelia test negative, Fatigue, Headache
Clinical narrative: Severe headaches from two days after the first shot to present.  Never had headache issues before. Abdominal Pain started day after first shot and has continued since. Extreme fatigue started 2 days after vaccine and is still present. Muscle twitching started the day after 2nd shot. Skin feels like it is burning.  Started the day after second shot.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Skin burning sensation
Clinical narrative: Severe headaches from two days after the first shot to present.  Never had headache issues before. Abdominal Pain started day after first shot and has continued since. Extreme fatigue started 2 days after vaccine and is still present. Muscle twitching started the day after 2nd shot. Skin feels like it is burning.  Started the day after second shot.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Crying, Dizziness, Dyspnoea
Clinical narrative: Twenty minutes after I received the vaccine, I was home and started to feel dizzy, light headed, and numb. My body felt extremely cold and I had to sit in the car with the doors closed to feel hotter under the weather. I probably stayed in the car close to 10 minutes. Then, I went into the house and I started feeling waves of cold so I immediately went and sat in the yard for another 15 minutes. This was one of the worst times. I could not move my face, arms, fingers, or legs and I was literally crying and trying to breathe. There was a numbing sensation that stretched from my finger tips to my arms, legs, toes, and across the chest (like a "u" shape). I told my dad at the time to get the phone ready to dial 911 just in case. This was very similar but slightly worse reaction when compared to the first vaccine I got 28 days earlier. I moved back into the house and had to be under blankets for the next 10 minutes. It was very difficult because my entire body was numb, like it was locked up in one posture. After another 15 minutes, it started getting better but it felt like my heart had taken a pounding.   Later this evening, I started feeling chills again with my teeth clattering. I had to go under blankets. I had my watch on and it said my HR was 80. I used my dad's oxygen device and it said 97%. My heart felt heavy again, as if it had done a lot of work.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Mobility decreased, Movement disorder, Nasopharyngitis
Clinical narrative: Twenty minutes after I received the vaccine, I was home and started to feel dizzy, light headed, and numb. My body felt extremely cold and I had to sit in the car with the doors closed to feel hotter under the weather. I probably stayed in the car close to 10 minutes. Then, I went into the house and I started feeling waves of cold so I immediately went and sat in the yard for another 15 minutes. This was one of the worst times. I could not move my face, arms, fingers, or legs and I was literally crying and trying to breathe. There was a numbing sensation that stretched from my finger tips to my arms, legs, toes, and across the chest (like a "u" shape). I told my dad at the time to get the phone ready to dial 911 just in case. This was very similar but slightly worse reaction when compared to the first vaccine I got 28 days earlier. I moved back into the house and had to be under blankets for the next 10 minutes. It was very difficult because my entire body was numb, like it was locked up in one posture. After another 15 minutes, it started getting better but it felt like my heart had taken a pounding.   Later this evening, I started feeling chills again with my teeth clattering. I had to go under blankets. I had my watch on and it said my HR was 80. I used my dad's oxygen device and it said 97%. My heart felt heavy again, as if it had done a lot of work.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Constant tinnitus alternating in both ears, varying in intensity, the sound is whining. Started on 4/28/2021 upon waking up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Palpitations
Clinical narrative: Heart palpitations daily and frequently occurred very recently after the second dose. I began having mild chest pain approx. 2 months after, progressive to intermittently moderately several times weekly, has now progressed to daily mild to moderate L sided chest pain, with  one episode of severe on 7/27/21. The mild to moderate pain has continued almost constantly since then.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Headache, Myalgia
Clinical narrative: I had a severe headache and muscle soreness after the vaccine. I was 6 months pregnant with my second child. They were born full term on May 30th, normal, healthy, weighing 8lbs 15oz.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Erythema, Oropharyngeal pain, Urticaria
Clinical narrative: Hives, anxiety, sore throat, redness, weakness,
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Generalised tonic-clonic seizure
Clinical narrative: Grand mal seizure took place about 10 minutes after administration. Paramedics arrived on scene after seizure had ended. Upon examining the patient, EMT determined the pt was fit to go home
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: VARlVAX had a temperature excursion and was administered; Additional AE's were reported; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On an unknown date, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot# T028306 has been verified to be a valid lot number, expiration date was reported as 20-AUG-2022; strength and route were not reported) 5 ml once for prophylaxis. The vaccine was stored under 4 Fahrenheit (F) for 24 hours. There was no previous temperature excursion. On 28-JUN-2021, the patient experienced unspecified adverse event. The outcome of the event was unknown. The causality assessment between the event and varicella virus vaccine live (oka/merck) (VARIVAX) was not reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2107USA000237:01957083 US-009507513-2107USA000111:01957080 US-009507513-2107USA000236:01957053 US-009507513-2107USA000238:01957079
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE; Patient was administered expired MMRll on 07/07/2021; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 07-JUL-2021, the patient was vaccinated with an expire dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) lot number S020162 has been verified to be a valid lot number, expiration date 30-JUN-2021 (dosage regimen and route of administration were not reported) for prophylaxis. No adverse event was reported. The vaccine had not had temperature excursions.  This is a non-valid case due to the lack of patient identifiers.  Follow-up information has been received from the office manager on 21-JUL-2021. The patient was a 12-month-old female. Her address was provided. The patient did not have allergies. It was reported that "active problems" included maternal history of hepatitis C and Coombs test. She had no history of an adverse event following previous vaccinations nor other illnesses at the time of vaccination. Birth weight was 7 lb 13 oz. She was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) administered subcutaneously in the left thigh. On the same date, she was vaccinated with pneumococcal vaccine conj 13v (crm197) (PREVENAR 13) and hepatitis a vaccine inact (HAVRIX). It was reported that the patient tolerated the adverse event well. It was a single use vaccine/ vaccine-device and it was used according to the instruction leaflet. The operator of the device was a healthcare professional and they were trained. The vaccine was available for return/evaluation. The adverse event was reported to a doctor.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: no other AE occurred; dose of ROT ATEQ that was administered after the expiration date.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 12-JUL-2021, the patient was vaccinated with expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1691140, expiration date: 10-JUL-2021, dose reported as 1 dose, orally (dose number and exact dose were not reported) for prophylaxis. No adverse event occurred.
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported; administered on 07/16/2021 after it had expired on 07/11/2021; This spontaneous report was received from a licensed vocational nurse and refers to a 9-week-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 16-JUL-2021, the patient was vaccinated with expired dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) injection, 0.5 milliliter, lot # R027327, expiration date 11-JUL-2021 (route of administration and injection site were not reported) for prophylaxis. No temperature excursion had occurred. No additional adverse events were reported.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: temperature excursion for PNEUMOVAX 23; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concomitant medications or concurrent conditions was provided.  On 08-JUL-2021, the patient was vaccinated with an improperly stored dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) lot # T034630 was confirmed to be valid, expiration date 22-JUN-2022 (dose, route and site of administration were not reported), for prophylaxis. The administered dose was exposed to the temperature of 75 degrees Fahrenheit (F) for 960 hours. It was reported that the call was not because of a digital data logger and there was no previous temperature excursion.
Sex: U
Vaccine: HPV4, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: an unspecified human papillomavirus vaccine; No additional AEs reported; first dose of an unspecified human papillomavirus vaccine in June 2018. The patient received a first dose of an unspecified human papillomavirus vaccine in June 2018. The patient received a; This spontaneous report as received from a physician's assistant refers to an adolescent patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On an unknown date in June 2018, at 16 years old, the patient was vaccinated with an unspecified human papillomavirus vaccine (manufacturer unknown) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On an unknown date in July 2019, the patient received the second dose of an unspecified human papillomavirus vaccine (manufacturer unknown) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis (product origin unknown and inappropriate schedule of product administration). No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Localised infection, Muscle rupture
Clinical narrative: tore the muscle / went to the hospital and has been in PT since; arm got so inflamed / went to the hospital and has been in PT since; arm / infected / went to the hospital and has been in PT since; This case was reported by a pharmacist via sales rep and described the occurrence of torn muscle in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced torn muscle (serious criteria GSK medically significant), inflammation localized and arm infection. On an unknown date, the outcome of the torn muscle, inflammation localized and arm infection were unknown.   It was unknown if the reporter considered the torn muscle, inflammation localized and arm infection to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that she received the 1st dose of Shingrix and less than 4 months after the vaccination she experienced inflamed arm and it got infected and tore the muscle. The patient went to the hospital and had been in PT (Physical therapy) since after 1st dose. The reporter stated that they called the patient to schedule 2nd Shingrix dose.
Sex: F
Vaccine: MENB
Symptoms: Feeling abnormal, Gait disturbance, Hypersomnia
Clinical narrative: Foggy mind; wobbly gait; Slept a lot; This case was reported by a nurse via sales rep and described the occurrence of foggy feeling in head in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, less than an hour after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced foggy feeling in head, abnormal gait and sleep excessive. On an unknown date, the outcome of the foggy feeling in head, abnormal gait and sleep excessive were recovered/resolved.   It was unknown if the reporter considered the foggy feeling in head, abnormal gait and sleep excessive to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Bexsero in summer of 2017. Within 30 to 40 minutes after receiving Bexsero, the patient started having wobbly gait and foggy mind. The reporter believed that the patient slept a lot. The patient did not went to the emergency room but did recover. The reporter did not consent to follow up. This case has been linked with the case US2021155645, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021155645:Same reporter