chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood glucose normal, Blood magnesium normal, Brain natriuretic peptide increased, C-reactive protein normal, Cardiac electrophysiologic study normal
Clinical narrative: PSVT with syncope morning of 1/19,  10 episodes of SVT lasting about 5 seconds, followed by syncome then return of NSR, spontaneous resolution. Hospital admission 1/19 with telemetry,  normal electrophysiology study, loop recorder placement. discharged 1/21 with no recurrence.
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cardiac telemetry, Full blood count, Implantable cardiac monitor insertion, Metabolic function test, Platelet count decreased
Clinical narrative: PSVT with syncope morning of 1/19,  10 episodes of SVT lasting about 5 seconds, followed by syncome then return of NSR, spontaneous resolution. Hospital admission 1/19 with telemetry,  normal electrophysiology study, loop recorder placement. discharged 1/21 with no recurrence.
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Red blood cell sedimentation rate normal, Supraventricular tachycardia, Syncope, Troponin normal
Clinical narrative: PSVT with syncope morning of 1/19,  10 episodes of SVT lasting about 5 seconds, followed by syncome then return of NSR, spontaneous resolution. Hospital admission 1/19 with telemetry,  normal electrophysiology study, loop recorder placement. discharged 1/21 with no recurrence.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Anxiety, Behaviour disorder, Crying, Erythema, Irritability
Clinical narrative: Arm began hurting few hours after administration.  Around 1am that night after the vaccine he started with a fever and his arm was visibly red and swollen, and he complained it hurt especially when moving it. He slept until 11am the next day. When he woke up he still had a fever, redness and swelling in arm and slept off and on all day. He was unusually fussy even more so than usual when not feeling well. He was crying off an on all day over nothing.  He also started getting muscle tics and twitches. The tics occurred in his face and also his arms and legs, both while sleeping and when awake.  The fever and arm redness and swelling lasted for approximately 3 days before resolving. However the tics/twitches and mood/behavioral changes continued and got drastically worse.  He developed sever separation anxiety and just anxiety about things that he never had before and things that make no sense. It is becoming almost obsessive in these anxiety's and worries. He cry's frequently through out the day. The tics/twitches occur during rest and activity.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Malaise, Mood altered, Muscle twitching, Pain, Pain in extremity
Clinical narrative: Arm began hurting few hours after administration.  Around 1am that night after the vaccine he started with a fever and his arm was visibly red and swollen, and he complained it hurt especially when moving it. He slept until 11am the next day. When he woke up he still had a fever, redness and swelling in arm and slept off and on all day. He was unusually fussy even more so than usual when not feeling well. He was crying off an on all day over nothing.  He also started getting muscle tics and twitches. The tics occurred in his face and also his arms and legs, both while sleeping and when awake.  The fever and arm redness and swelling lasted for approximately 3 days before resolving. However the tics/twitches and mood/behavioral changes continued and got drastically worse.  He developed sever separation anxiety and just anxiety about things that he never had before and things that make no sense. It is becoming almost obsessive in these anxiety's and worries. He cry's frequently through out the day. The tics/twitches occur during rest and activity.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Peripheral swelling, Pyrexia, Separation anxiety disorder, Tic
Clinical narrative: Arm began hurting few hours after administration.  Around 1am that night after the vaccine he started with a fever and his arm was visibly red and swollen, and he complained it hurt especially when moving it. He slept until 11am the next day. When he woke up he still had a fever, redness and swelling in arm and slept off and on all day. He was unusually fussy even more so than usual when not feeling well. He was crying off an on all day over nothing.  He also started getting muscle tics and twitches. The tics occurred in his face and also his arms and legs, both while sleeping and when awake.  The fever and arm redness and swelling lasted for approximately 3 days before resolving. However the tics/twitches and mood/behavioral changes continued and got drastically worse.  He developed sever separation anxiety and just anxiety about things that he never had before and things that make no sense. It is becoming almost obsessive in these anxiety's and worries. He cry's frequently through out the day. The tics/twitches occur during rest and activity.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral, Tinnitus
Clinical narrative: 2 days following injection work up with severe hearing loss in left ear.  Hearing has not returned.  Tinnitus in left ear persists.
Age: 3.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: No symptoms
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Product storage error
Clinical narrative: Pt administer with Bivalent booster vial that had been thawed 4-6 weeks beyond unfrozen date.  No adverse signs and symptoms reported.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received the 1st dose of a 3 doses series of the Covid-19 vaccine BUD-expiration date. As per Doctor patient needs to repeat the 1st dose of the series. Mother was contacted and is aware. Patient is in good condition and had no symptoms or side effect related to the vaccine. Patient has an appointment for patient to repeat the vaccine on 01/31/2023.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Pt administer with Bivalent booster vial that had been thawed 4-6 weeks beyond unfrozen date.  No adverse signs and symptoms reported.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Alopecia, Fatigue, Headache, Laboratory test, Menstruation irregular
Clinical narrative: Irregular period, poly cystic ovary syndrome, hair loss, headache, fatigue, nausea and stiffness
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Musculoskeletal stiffness, Nausea, Polycystic ovaries
Clinical narrative: Irregular period, poly cystic ovary syndrome, hair loss, headache, fatigue, nausea and stiffness
Age: 0.92
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Diarrhoea haemorrhagic, Febrile convulsion, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: Patient was sick with a low fever and diarrhea shortly after his 1st birthday. His fever increased and he had a febrile seizure and went to the ER. The next day was his 1 year appointment with his doctor and we discussed the event.  His diarrhea continued and had blood it in so the next day we took him to the weekend drop in at his pediatricians office. They did a stool sample and we found out that he had salmonella. No idea if it's related to the covid vaccine. Also, his pediatricians office gave him his 3rd does of the covid vaccine on the immune compromised schedule by mistake because Patient is not immune compromised. Not sure if that is an important detail.
Age: 0.92
Sex: M
Vaccine: COVID19
Symptoms: Salmonella test positive, Salmonellosis
Clinical narrative: Patient was sick with a low fever and diarrhea shortly after his 1st birthday. His fever increased and he had a febrile seizure and went to the ER. The next day was his 1 year appointment with his doctor and we discussed the event.  His diarrhea continued and had blood it in so the next day we took him to the weekend drop in at his pediatricians office. They did a stool sample and we found out that he had salmonella. No idea if it's related to the covid vaccine. Also, his pediatricians office gave him his 3rd does of the covid vaccine on the immune compromised schedule by mistake because Patient is not immune compromised. Not sure if that is an important detail.
Age: 35.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Pt administer with Bivalent booster vial that had been thawed 4-6 weeks beyond unfrozen date.  No adverse signs and symptoms reported.
Age: 47.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, Product storage error
Clinical narrative: Pt administer with Bivalent booster vial that had been thawed 4-6 weeks beyond unfrozen date.  No adverse signs and symptoms reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Administration of Non-Viable Vaccine.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Patient was vaccinated 1/23/21, 2/20/21 and 1/24/22 with Moderna.  He became covid +ve 1/11/23 and expired 1/24/23.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given varicella vaccine 3 weeks after receiving MMR vaccine. No adverse signs/symptoms seen at appointment time or reported by patient/parent.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Swollen tongue, Tongue dry
Clinical narrative: immediate intense dryness of the tongue. Given water. felt a little better. left and had some swelling of my tongue on my way home.  I took Benedryl , which took care of the situation. I did not contact the pharmacy or any medical provider. I took another Benedryl,  6 hours later as a safety measure, although my tongue felt ok.  I will not get another Bivalent shot. I felt a need to submit this report due to the fact the combined vaccine projected to be used,  I saw on the news will contain the Bivalent vaccine and the flu shot. I want you to know that for some of us,    the original covid vaccine is a better option.
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, Product storage error
Clinical narrative: Pt administer with Bivalent booster vial that had been thawed 4-6 weeks beyond unfrozen date.  No adverse signs and symptoms reported.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Breast feeding, Mammogram, Mammogram abnormal, Mastitis, Maternal exposure before pregnancy
Clinical narrative: I was pregnant when I received the first two doses of the vaccine, then a little over a month after my baby was born I received a booster. All were in my right arm. I breast fed and during the first 5 months of my babies life I had mastitis 3 times in the right breast. Each time it was treated with antibiotics (not always the same antibiotic).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound breast
Clinical narrative: I was pregnant when I received the first two doses of the vaccine, then a little over a month after my baby was born I received a booster. All were in my right arm. I breast fed and during the first 5 months of my babies life I had mastitis 3 times in the right breast. Each time it was treated with antibiotics (not always the same antibiotic).
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Administration of Non-Viable Vaccine.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: It was discovered that our supply of moderna was past it's beyond use date. The patient was notified on 01/27/2023. Pt was advised to contact doctor about revaccination.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: It was discovered that our supply of moderna was past it's beyond use date. The patient was notified on 01/27/2023. Pt was advised to contact doctor about revaccination.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Administration of Non-Viable Vaccine.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: It was discovered that our supply of moderna was past it's beyond use date. The patient was notified on 01/27/2023. Pt was advised to contact doctor about revaccination.
Age: 1.33
Sex: F
Vaccine: IPV
Symptoms: Dehydration, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Puking, Diarrhea, Fever, Dehydration
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: It was discovered that our supply of moderna was past it's beyond use date. The patient was notified on 01/27/2023. Pt was advised to contact doctor about revaccination.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: It was discovered that our supply of moderna was past it's beyond use date. The patient was notified on 01/27/2023. Pt was advised to contact doctor about revaccination.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Administration of Non-Viable Vaccine.
Age: 21.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: It was discovered that our supply of moderna was past it's beyond use date. The patient was notified on 01/27/2023. Pt was advised to contact doctor about revaccination.
Age: 1.5
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients Received Covid-19 vaccine 1st dose of 3 series vaccine BUD-expiration date. Provider recommended patients to repeat the 1st dose of the vaccine. Patient's mother was contacted and made aware of the adverse event. Patient has appointment to repeat the vaccine on 01/31/2023. Patient is in good health condition. patient had no symptom or side effect due to the adverse event.
Age: 1.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Pt was supposed to receive the monovalent covid 19 pfizer vaccine but instead received the bivalent vaccine. no adverse reactions.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: It was discovered that our supply of moderna was past it's beyond use date. The patient was notified on 01/27/2023. Pt was advised to contact doctor about revaccination.
Age: 89.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Biopsy skin, Mass, Pruritus, Rash, Urticaria
Clinical narrative: extremely, horribily itchy hives/rash/welt areas that pop up sporadically at random places on torso (front and back), arms, fingers, hands, neck, head, eyelid, ears, and legs.
Age: 37.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: It was discovered that our supply of moderna was past it's beyond use date. The patient was notified on 01/27/2023. Pt was advised to contact doctor about revaccination.
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Rash
Clinical narrative: WHOLE BODY RASH. HE WENT TO THE DR ON 01/20/23 AND SHE PRESCRIBED HYDROXYZINE PAMOATE 25MG FOR 6 DAYS. CEPHALEXIN 500MG FOR 10 DAYS. THEN ON 1/24/23 SHE PRESCRIBED PREDNISONE 20MG FOR 7 DAYS.
Age: 44.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: It was discovered that our supply of moderna was past it's beyond use date. The patient was notified on 01/27/2023. Pt was advised to contact doctor about revaccination.
Age: 24.0
Sex: M
Vaccine: HPV9, TD
Symptoms: Asthenia, Blood glucose normal, Blood thyroid stimulating hormone, Dizziness, Dyspnoea
Clinical narrative: Pt had 2 syncopal episodes at work early on morning of 1/26 (works overnight shift). He became weak, dizzy, flushed, a friend helped him to the ground and he said he was passed out nearly 20 minutes.  He was aware of surroundings but felt weak and couldn't respond.  Had second similar episode around 7 am after reaching home.   Came to clinic 10:30 am and was flushed and complaining of difficulty getting his breath and blurry vision.  had normal vitals and oxygen and no swelling of lips/tongue. He had some facial flushing.  He was alert and awake but weak and needed assistance walking.   It is not clear if this was related to vaccination of one or both of vaccines but patient had no prior history of syncope and no apparent other changes in routine or illnesses.
Age: 24.0
Sex: M
Vaccine: HPV9, TD
Symptoms: Electrocardiogram normal, Flushing, Full blood count normal, Gait disturbance, Loss of consciousness
Clinical narrative: Pt had 2 syncopal episodes at work early on morning of 1/26 (works overnight shift). He became weak, dizzy, flushed, a friend helped him to the ground and he said he was passed out nearly 20 minutes.  He was aware of surroundings but felt weak and couldn't respond.  Had second similar episode around 7 am after reaching home.   Came to clinic 10:30 am and was flushed and complaining of difficulty getting his breath and blurry vision.  had normal vitals and oxygen and no swelling of lips/tongue. He had some facial flushing.  He was alert and awake but weak and needed assistance walking.   It is not clear if this was related to vaccination of one or both of vaccines but patient had no prior history of syncope and no apparent other changes in routine or illnesses.
Age: 24.0
Sex: M
Vaccine: HPV9, TD
Symptoms: Metabolic function test, Syncope, Unresponsive to stimuli, Urine analysis normal, Vision blurred
Clinical narrative: Pt had 2 syncopal episodes at work early on morning of 1/26 (works overnight shift). He became weak, dizzy, flushed, a friend helped him to the ground and he said he was passed out nearly 20 minutes.  He was aware of surroundings but felt weak and couldn't respond.  Had second similar episode around 7 am after reaching home.   Came to clinic 10:30 am and was flushed and complaining of difficulty getting his breath and blurry vision.  had normal vitals and oxygen and no swelling of lips/tongue. He had some facial flushing.  He was alert and awake but weak and needed assistance walking.   It is not clear if this was related to vaccination of one or both of vaccines but patient had no prior history of syncope and no apparent other changes in routine or illnesses.
Age: 19.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No signs or symptoms of adverse reaction
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: It was discovered that our supply of moderna was past it's beyond use date. The patient was notified on 01/27/2023. Pt was advised to contact doctor about revaccination.
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: It was discovered that our supply of moderna was past it's beyond use date. The patient was notified on 01/27/2023. Pt was advised to contact doctor about revaccination.
Age: 24.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pruritus, Rash
Clinical narrative: Patient states 1 week after vaccine she developed a full body prickly rash on her back, arms, neck, and stomach. Only a little itchy and not located at injection site.  She has been taking Zyrtec with only slight improvement.
Age: 40.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: It was discovered that our supply of moderna was past it's beyond use date. The patient was notified on 01/27/2023. Pt was advised to contact doctor about revaccination.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: HOSPITAL
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine refrigeration date expired. No adverse reactions.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Atrial fibrillation, Atrial flutter, Cardioversion, Heart rate increased
Clinical narrative: A few months after receiving the vaccine I started to experience brief heart palpitations.  At that time did not realize what it was that I was experiencing.  These sensations were very brief, random and were months apart.  In the last 6 months these sensations increased in frequency,  and intensity, starting to happen weekly.  On 1/23/2023 in the early morning (4:30) while at rest I experience the sensation again.  but this time my heart started to feel like it was pounding,  My heart rate elevated to 130 BPM and would spike to 150+.  This did not resolve.  By 7PM I went to the  Emergency Room.  I was diagnosed with Atrial flutter/fib.  The end result was needing a cardioversion, and now a life long medications of Metoprolol and Eliquis.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations
Clinical narrative: A few months after receiving the vaccine I started to experience brief heart palpitations.  At that time did not realize what it was that I was experiencing.  These sensations were very brief, random and were months apart.  In the last 6 months these sensations increased in frequency,  and intensity, starting to happen weekly.  On 1/23/2023 in the early morning (4:30) while at rest I experience the sensation again.  but this time my heart started to feel like it was pounding,  My heart rate elevated to 130 BPM and would spike to 150+.  This did not resolve.  By 7PM I went to the  Emergency Room.  I was diagnosed with Atrial flutter/fib.  The end result was needing a cardioversion, and now a life long medications of Metoprolol and Eliquis.
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute respiratory failure, Angiogram pulmonary abnormal, Blood creatine phosphokinase increased, COVID-19, Condition aggravated
Clinical narrative: Patient with history of 3 COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  " patient was brought into the emergency department via EMS complaining of fall.  On arrival he had acute metabolic encephalopathy acute hypoxic respiratory failure and right hip fracture.  Ortho was consulted.  CTA ordered showed subsegmental pulmonary embolism with no evidence of right heart strain.  He was on 5 L venturi mask for respiratory support.  CPK elevated at 242.  Echo read ejection fraction 55-60%.  Ortho perform the operation for right hip hemiarthroplasty to repair in the right hip femoral neck fracture.  X-ray obtained post surgically shows surgical hardware aligned intact.  Patient continue to see PT OT following surgery for rehab.  PT recommended skilled nursing facility for continued rehab.  Following 10 days for COVID duration patient left to SNF."
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Echocardiogram normal, Ejection fraction normal, Fall, Hip arthroplasty, Hip fracture
Clinical narrative: Patient with history of 3 COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  " patient was brought into the emergency department via EMS complaining of fall.  On arrival he had acute metabolic encephalopathy acute hypoxic respiratory failure and right hip fracture.  Ortho was consulted.  CTA ordered showed subsegmental pulmonary embolism with no evidence of right heart strain.  He was on 5 L venturi mask for respiratory support.  CPK elevated at 242.  Echo read ejection fraction 55-60%.  Ortho perform the operation for right hip hemiarthroplasty to repair in the right hip femoral neck fracture.  X-ray obtained post surgically shows surgical hardware aligned intact.  Patient continue to see PT OT following surgery for rehab.  PT recommended skilled nursing facility for continued rehab.  Following 10 days for COVID duration patient left to SNF."
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Medical device implantation, Metabolic encephalopathy, Pulmonary embolism, SARS-CoV-2 test positive, X-ray of pelvis and hip normal
Clinical narrative: Patient with history of 3 COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  " patient was brought into the emergency department via EMS complaining of fall.  On arrival he had acute metabolic encephalopathy acute hypoxic respiratory failure and right hip fracture.  Ortho was consulted.  CTA ordered showed subsegmental pulmonary embolism with no evidence of right heart strain.  He was on 5 L venturi mask for respiratory support.  CPK elevated at 242.  Echo read ejection fraction 55-60%.  Ortho perform the operation for right hip hemiarthroplasty to repair in the right hip femoral neck fracture.  X-ray obtained post surgically shows surgical hardware aligned intact.  Patient continue to see PT OT following surgery for rehab.  PT recommended skilled nursing facility for continued rehab.  Following 10 days for COVID duration patient left to SNF."
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Abdominal pain lower, Autonomic nervous system imbalance, Dizziness, Dyspnoea, Echocardiogram
Clinical narrative: Discussion with Mom - Dysautonomia symptoms have increased in frequency over the past year. Pt.'s History likely started before Gardasil but symptoms worsened 1 month after it. ... 12-08-15 Tachycardia, Family history Long QT -> EKG, 48-hr Holter WNL ... 04-21-21 seen by me for Int Chr Abd Pain, Family history Crohn's in mom -> Labs WNL  ... 09-08-21 seen by me for 12 3/12 yo WCC, Gardasil #1, Flu V x1 ... 11-02-21 ED: RLQ pain, Palpitations -> EKG, Pelvic USZ WNL ... 02-01-22 symptoms over the past year c/w Dysautonomia ...   Symptoms x1 yr intermittent Palpitations, lightheaded, labored breathing ...   Orthostatics HR increased 88 -> 114 ...   w/u WNL: EKG, ECHO, Treadmill, 2 wk Monitor ... 12-14-22 meets criteria for Dysautonomia / POTS ...   Orthostatics HR increased  71 -> 107, 116, 122
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Electrocardiogram ambulatory normal, Electrocardiogram normal, Exercise electrocardiogram, Heart rate increased, Laboratory test normal
Clinical narrative: Discussion with Mom - Dysautonomia symptoms have increased in frequency over the past year. Pt.'s History likely started before Gardasil but symptoms worsened 1 month after it. ... 12-08-15 Tachycardia, Family history Long QT -> EKG, 48-hr Holter WNL ... 04-21-21 seen by me for Int Chr Abd Pain, Family history Crohn's in mom -> Labs WNL  ... 09-08-21 seen by me for 12 3/12 yo WCC, Gardasil #1, Flu V x1 ... 11-02-21 ED: RLQ pain, Palpitations -> EKG, Pelvic USZ WNL ... 02-01-22 symptoms over the past year c/w Dysautonomia ...   Symptoms x1 yr intermittent Palpitations, lightheaded, labored breathing ...   Orthostatics HR increased 88 -> 114 ...   w/u WNL: EKG, ECHO, Treadmill, 2 wk Monitor ... 12-14-22 meets criteria for Dysautonomia / POTS ...   Orthostatics HR increased  71 -> 107, 116, 122
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Orthostatic heart rate test, Palpitations, Postural orthostatic tachycardia syndrome, Tachycardia
Clinical narrative: Discussion with Mom - Dysautonomia symptoms have increased in frequency over the past year. Pt.'s History likely started before Gardasil but symptoms worsened 1 month after it. ... 12-08-15 Tachycardia, Family history Long QT -> EKG, 48-hr Holter WNL ... 04-21-21 seen by me for Int Chr Abd Pain, Family history Crohn's in mom -> Labs WNL  ... 09-08-21 seen by me for 12 3/12 yo WCC, Gardasil #1, Flu V x1 ... 11-02-21 ED: RLQ pain, Palpitations -> EKG, Pelvic USZ WNL ... 02-01-22 symptoms over the past year c/w Dysautonomia ...   Symptoms x1 yr intermittent Palpitations, lightheaded, labored breathing ...   Orthostatics HR increased 88 -> 114 ...   w/u WNL: EKG, ECHO, Treadmill, 2 wk Monitor ... 12-14-22 meets criteria for Dysautonomia / POTS ...   Orthostatics HR increased  71 -> 107, 116, 122
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Administration of Non-Viable Vaccine.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received  Covid-19 vaccine 1st dose of 3 doses series BUD-expiration date. Patient mother was made aware of the adverse event. Patient had no symptoms or side effect related to the adverse event. Doctor recommended patient to be revaccinated, mother refuse to revaccinate patient. she stated she was not planning on completing the initial series that patient started.
Age: 70.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Retching, Vomiting
Clinical narrative: Vomiting.  15 minutes in duration.  Mostly dry heaves although some liquid was expelled.
Age: 70.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting.  15 minutes in duration.  Mostly dry heaves although some liquid was expelled.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: new patient came in and care gap noted he was due for covid booster dose. covid bivalent booster dose given. after dose given, patient clarified that he had only received the initial covid vaccine shot and never got second shot or (non-bivalent) booster.   No adverse reaction noted.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Arachnoid cyst, Headache, Impaired work ability, Magnetic resonance imaging head abnormal, New daily persistent headache
Clinical narrative: On 06/05/2021, I began having headaches on the left side of my head, every day from 03:00PM to 05:00PM for several weeks. On 10/06/2022, I felt a sensation on the left side of my face. I thought I was having a stroke. I went to the emergency room. They did an MRI of my head. I have a Left Interior Arachnoid Temporal Cyst diagnosis on the left side of my head. I continue to have headaches every day. I had to quit my job due to the headaches.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Sensory disturbance
Clinical narrative: On 06/05/2021, I began having headaches on the left side of my head, every day from 03:00PM to 05:00PM for several weeks. On 10/06/2022, I felt a sensation on the left side of my face. I thought I was having a stroke. I went to the emergency room. They did an MRI of my head. I have a Left Interior Arachnoid Temporal Cyst diagnosis on the left side of my head. I continue to have headaches every day. I had to quit my job due to the headaches.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Mouth swelling, Oral herpes, Pain, Toothache
Clinical narrative: Started with tooth ache. Very painful, like i needed a root canal. Couldn't get into dentist for 1 week. Felt bad all over. Just thought it was from the pain. Slept on heating pad which helped. Couldn't do normal activities due to pain making me feel bad all over. Went to dentist this morning 1/27/23. He told me it is intraoral herpes in mouth. Swelling has affected my two upper back teeth pushing one of my crowns down which he may have to address after the lesions are gone in my mouth. He thinks another week.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: X-ray
Clinical narrative: Started with tooth ache. Very painful, like i needed a root canal. Couldn't get into dentist for 1 week. Felt bad all over. Just thought it was from the pain. Slept on heating pad which helped. Couldn't do normal activities due to pain making me feel bad all over. Went to dentist this morning 1/27/23. He told me it is intraoral herpes in mouth. Swelling has affected my two upper back teeth pushing one of my crowns down which he may have to address after the lesions are gone in my mouth. He thinks another week.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: Systemic: periocarditis-Medium, Additional Details: patient reports having instances of periocarditis starting in May of 2022.  Per shot records - 3rd dose of Pfizer vaccine given 10-13-2021, and the most recent booster Pfizer Bivalent given 10-13-22
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold, Laboratory test, Pyrexia
Clinical narrative: He developed a high fever of 104F, acute onset body chills, fatigue while he was in the bath on a Friday evening. He said he felt very cold in a warm bath and had some congestion. I decided to check his temperature; when we noticed how high his fever was, we gave him ibuprofen. The next morning, his fever was still pretty high so we decided to take him to the urgent care shortly after on 01/07/2023. They tested him for strep and viral infection panel including COVID-19, pneumonia, RSV and others. no change in treatment; they prescribed him MOTRIN and told us to keep him hydrated and allow him to rest. Three weeks prior, he had been treated with a steroid and antibiotic for congestion and early signs of pneumonia. They prescribed him prednisone at that time. He slowly got better, but my wife and I thought it was a second infection that could be developing which triggered this current one. Right now, he's doing much better and feeling fine.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory syncytial virus test, Respiratory tract congestion, SARS-CoV-2 test, Streptococcus test, Viral test
Clinical narrative: He developed a high fever of 104F, acute onset body chills, fatigue while he was in the bath on a Friday evening. He said he felt very cold in a warm bath and had some congestion. I decided to check his temperature; when we noticed how high his fever was, we gave him ibuprofen. The next morning, his fever was still pretty high so we decided to take him to the urgent care shortly after on 01/07/2023. They tested him for strep and viral infection panel including COVID-19, pneumonia, RSV and others. no change in treatment; they prescribed him MOTRIN and told us to keep him hydrated and allow him to rest. Three weeks prior, he had been treated with a steroid and antibiotic for congestion and early signs of pneumonia. They prescribed him prednisone at that time. He slowly got better, but my wife and I thought it was a second infection that could be developing which triggered this current one. Right now, he's doing much better and feeling fine.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Hypoglycaemia, Metabolic encephalopathy, SARS-CoV-2 test positive, Unresponsive to stimuli
Clinical narrative: "Patient with J+J COVID vaccine who admitted to hospital with COVID detected PCR.  Provider d/c note:  Patient is a 79 YO male history of diabetes, atrial fibrillation presents after being found unresponsive.  He was reported to be severely hypoglycemic on arrival.  He was incidentally found to be COVID-19 positive as well. He was subsequently admitted to the hospital for evaluation and management of acute metabolic encephalopathy due to hypo glycemia.   During his stay, he received half the dose of his long-acting insulin with out any further hypoglycemic episode.  His mentation has returned to baseline.  He stayed in the hospital longer despite being medically stable due to COVID clearance requirements for nursing home placement.  Strict return precautions given.
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Administration of Non-Viable Vaccine.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Impaired work ability, Pain, Pyrexia
Clinical narrative: Fever, extreme aches, fatigue in ability to work
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: patient after 1 week reported a rash and redness around the injection site
Age: 0.75
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Pt was supposed to receive the Pfizer covid -19 monovalent dose, instead received a bivalent dose. no adverse reactions
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Administration of Non-Viable Vaccine.
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Lymphadenopathy, Malaise, Oropharyngeal pain, Pain in extremity
Clinical narrative: Sore arm, swollen lymph nodes, rash by left hear/hairline, general fatigue and malaise, sore throat pain on left side of throat
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash
Clinical narrative: Sore arm, swollen lymph nodes, rash by left hear/hairline, general fatigue and malaise, sore throat pain on left side of throat
Age: 0.17
Sex: F
Vaccine: RV1, RV1
Symptoms: Barium double contrast, Feeding disorder, Haematochezia, Intussusception, Irritability
Clinical narrative: Fussiness started on January 20 and that evening child had vomiting and bloody stool and seemed to be getting better so after discussion with nurses on call did not go to the ER but the next day child vomited again and had another bloody stool and was taken to the emergency department at Hospital where intussusception was diagnosed and reduced with an air enema.  She was observed briefly doing well and was discharged to home without actually being admitted.  Since then she has had a couple of days of slower feeds but is doing well now and has a normal exam.
Age: 0.17
Sex: F
Vaccine: RV1, RV1
Symptoms: Vomiting, X-ray
Clinical narrative: Fussiness started on January 20 and that evening child had vomiting and bloody stool and seemed to be getting better so after discussion with nurses on call did not go to the ER but the next day child vomited again and had another bloody stool and was taken to the emergency department at Hospital where intussusception was diagnosed and reduced with an air enema.  She was observed briefly doing well and was discharged to home without actually being admitted.  Since then she has had a couple of days of slower feeds but is doing well now and has a normal exam.
Age: 0.17
Sex: F
Vaccine: RV1, RV1
Symptoms: Abdominal X-ray, Abdominal pain upper, Crying, Enema administration, Feeding disorder
Clinical narrative: Fussiness started on January 20 and that evening child had vomiting and bloody stool and seemed to be getting better so after discussion with nurses on call did not go to the ER but the next day child vomited again and had another bloody stool and was taken to the emergency department at Hospital where intussusception was diagnosed and reduced with an air enema.  She was observed briefly doing well and was discharged to home without actually being admitted.  Since then she has had a couple of days of slower feeds but is doing well now and has a normal exam.
Age: 0.17
Sex: F
Vaccine: RV1, RV1
Symptoms: Flatulence, Haematochezia, Intestinal obstruction, Intussusception, Surgery
Clinical narrative: Fussiness started on January 20 and that evening child had vomiting and bloody stool and seemed to be getting better so after discussion with nurses on call did not go to the ER but the next day child vomited again and had another bloody stool and was taken to the emergency department at Hospital where intussusception was diagnosed and reduced with an air enema.  She was observed briefly doing well and was discharged to home without actually being admitted.  Since then she has had a couple of days of slower feeds but is doing well now and has a normal exam.
Age: 0.17
Sex: F
Vaccine: RV1, RV1
Symptoms: Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Fussiness started on January 20 and that evening child had vomiting and bloody stool and seemed to be getting better so after discussion with nurses on call did not go to the ER but the next day child vomited again and had another bloody stool and was taken to the emergency department at Hospital where intussusception was diagnosed and reduced with an air enema.  She was observed briefly doing well and was discharged to home without actually being admitted.  Since then she has had a couple of days of slower feeds but is doing well now and has a normal exam.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: NON-VIABLE VACCINE ADMINISTRATION
Age: 47.0
Sex: F
Vaccine: COVID19-2, FLU4, PNC20
Symptoms: Incorrect product formulation administered
Clinical narrative: none
Age: 57.0
Sex: F
Vaccine: COVID19-2, FLU4, PNC20
Symptoms: Incorrect product formulation administered
Clinical narrative: none
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes on left side (left breast, underarm left side), swollen lypmph under lerft jaw and left side of face
Age: 39.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: Positive covid 19 test
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Administration of Non-Viable Vaccine.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No adverse events. Patient was suppossed to get the pfizer covid -19 (5-11 yr) bivalent vaccine and was given the pfizer covid -19 (5-11 yr) monovalent vaccine. Patient is doing fine.
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, COVID-19, Chest X-ray, Chills, Electrocardiogram
Clinical narrative: 10/4/22 Flu vaccine bad reaction, chills, muscle aches for 3 days. 10/8/22 came down with covid, sore throat, muscle aches & 10/9/22 Guillian-Barre symptoms started, fell & couldn't get up, 1:00 AM fell again trying to go to bathroom & couldn't use arms or legs. Called 911 & EMTs came, lost control of bladder, they helped me to bathroom & back to bed. 6:00 AM tried to get out of bed but fell on floor, paralyzed could not even crawl. Taken to emergency & admitted & put in isolation. Unable to get in or out of bed, sit up or roll over. Both ER doctors I had did not address the paralysis just covid.
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Fall, Guillain-Barre syndrome, Immunisation reaction, Mobility decreased, Musculoskeletal disorder
Clinical narrative: 10/4/22 Flu vaccine bad reaction, chills, muscle aches for 3 days. 10/8/22 came down with covid, sore throat, muscle aches & 10/9/22 Guillian-Barre symptoms started, fell & couldn't get up, 1:00 AM fell again trying to go to bathroom & couldn't use arms or legs. Called 911 & EMTs came, lost control of bladder, they helped me to bathroom & back to bed. 6:00 AM tried to get out of bed but fell on floor, paralyzed could not even crawl. Taken to emergency & admitted & put in isolation. Unable to get in or out of bed, sit up or roll over. Both ER doctors I had did not address the paralysis just covid.
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Oropharyngeal pain, Paralysis, Post-acute COVID-19 syndrome, Urinary incontinence
Clinical narrative: 10/4/22 Flu vaccine bad reaction, chills, muscle aches for 3 days. 10/8/22 came down with covid, sore throat, muscle aches & 10/9/22 Guillian-Barre symptoms started, fell & couldn't get up, 1:00 AM fell again trying to go to bathroom & couldn't use arms or legs. Called 911 & EMTs came, lost control of bladder, they helped me to bathroom & back to bed. 6:00 AM tried to get out of bed but fell on floor, paralyzed could not even crawl. Taken to emergency & admitted & put in isolation. Unable to get in or out of bed, sit up or roll over. Both ER doctors I had did not address the paralysis just covid.
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pruritus
Clinical narrative: Sligthly unbearable itchiness on injection site.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: PRESENTS FOR VARICELLA VACCINE #1. VACCINE WAS SCANNED AND ISSUED FOR ADMINISTRATNION TO PATIENT. VACCINE WAS ADMINISTRED AND PATIENT TOLERATED WELL. REQUESTED PATIENT REMAIN IN CLINIC FOR 20 MINUTES AFTER VACCINE GIVEN TO MONITOR FOR REACTIONS. AFTER VACCINE WAS ADMINISTERED, I WAS UNABLE TO DOCUMENT THE ADMINISTRATION AND REALIZED THAT THE VACCINE HAD, IN FACT, EXPIRED THE PREVIOUS DAY. THE EXPIRATION DATE WAS ON A WEEKEND DAY AND THE CLINIC WAS CLOSED, AND THE VACCINE WAS NOT PULLED TO PREVENT USEAGE.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test normal, Dizziness, Nausea, Vertigo
Clinical narrative: Vertigo - horrible dizziness and nausea 36 hours after shot that caused me to go to the hospital by ambulance. Felt symptoms for 2 days, but now continue to get intermittent vertigo,(1-2x/month) which I have never had in my life prior to the booster.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Staff member tested positive 1/27/23
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, X-ray
Clinical narrative: About four to six weeks after receiving the third dose (first booster) of Moderna, I started to experience unexplained joint pain. At first I thought I was just experiencing normal aches and pains, but they have continued throughout the past year. I am still seeing a rheumatologist because the pains are still unexplained. I have had multiple counts of blood work and X-Rays, but no one can seem to find the cause to the pains.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: PRESENTS FOR VARICELLA VACCINE #1. VACCINE WAS SCANNED AND ISSUED FOR ADMINISTRATNION TO PATIENT. VACCINE WAS ADMINISTRED AND PATIENT TOLERATED WELL. REQUESTED PATIENT REMAIN IN CLINIC FOR 20 MINUTES AFTER VACCINE GIVEN TO MONITOR FOR REACTIONS. AFTER VACCINE WAS ADMINISTERED, I WAS UNABLE TO DOCUMENT THE ADMINISTRATION AND REALIZED THAT THE VACCINE HAD, IN FACT, EXPIRED THE PREVIOUS DAY. THE EXPIRATION DATE WAS ON A WEEKEND DAY AND THE CLINIC WAS CLOSED, AND THE VACCINE WAS NOT PULLED TO PREVENT USEAGE.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Exposure to SARS-CoV-2, Flatulence, Lethargy
Clinical narrative: On December 26, 2022, he woke up with a cough, congestion, lack of appetite, and lethargy. We didn't test him for COVID-19, but both parents tested positive for COVID-19. It was assumed he was positive for COVID-19, too. He vomited once and had painful gas that prevented him from sleeping. His symptoms lasted approximately five days.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory tract congestion, Sleep disorder, Vomiting
Clinical narrative: On December 26, 2022, he woke up with a cough, congestion, lack of appetite, and lethargy. We didn't test him for COVID-19, but both parents tested positive for COVID-19. It was assumed he was positive for COVID-19, too. He vomited once and had painful gas that prevented him from sleeping. His symptoms lasted approximately five days.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Engerix B administered; This case was reported by a pharmacist via sales rep and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt date: 19-Jan-2023. Reporter's Comments: The reporter agrees to follow up from GlaxoSmithKline. Additional Supportive Information: The patient received expired Engerix B vaccine, which led to expired vaccine used.
Sex: F
Vaccine: HPV4
Symptoms: Postural orthostatic tachycardia syndrome, Seizure
Clinical narrative: seizure; POTS; Information has been received from a lawyer referring to a 15-year-old female patient regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (strength, dose, lot# and route unknown) for prophylaxis. On an unknown date, the patient experienced postural orthostatic tachycardia syndrome (POTS) and seizure. Reported date of injury was unspecified date in 2006. The outcome of the events was not reported. The causality assessment was considered as related by the lawyer.  Upon internal review, seizure was determined to be medically significant.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA006946: