chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: I started coughing. I had a recurrent dry cough, headache, fatigue and developed a brain fog. I took the COVID-19 test on February 01, 2023, and was positive. I was given molnupiravir for 5 days as well as benzonatate. It took 7 to 8 days to feel better. I used NASACORT allergy spray and DELSYM cough and congestion to treat the symptoms. My nose was also running. I still have some brain fog but I am getting everything back.
Age: 63.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Headache, Pyrexia, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test negative
Clinical narrative: In early February I had a headache and a runny nose which began to be congestion. I also had a low-grade fever for about 3 days and scratchy throat. I tested negative for COVID-19. I spoke to my doctor and he said go to the emergency department if it did not get better. I still have a little bit of a headache as of today and I am sneezing a lot.
Age: 63.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Sneezing, Throat irritation
Clinical narrative: In early February I had a headache and a runny nose which began to be congestion. I also had a low-grade fever for about 3 days and scratchy throat. I tested negative for COVID-19. I spoke to my doctor and he said go to the emergency department if it did not get better. I still have a little bit of a headache as of today and I am sneezing a lot.
Age: 21.0
Sex: M
Vaccine: COVID19-2
Symptoms: Body temperature increased, COVID-19, Condition aggravated, Electroencephalogram abnormal, Endotracheal intubation
Clinical narrative: Discharge Provider: MD Primary Care Provider: MD Admission Date: 2/24/2023 Discharge Date: Mar 7, 2023  PRESENTING PROBLEM: Status epilepticus COVID-19  Seizure  Pneumonia due to Klebsiella pneumoniae    HOSPITAL COURSE: Patient is a 21 year old male with  a past medical history of CP, global DD, complex partial epilepsy on multiple AEDs who presented to emergency department on 2/24  with multiple witnessed seizures at home. Per mom, the patient last had seizures in September 2022. On day of arrival, she noted 2 seizures for which she gave him IM ativan x 2 doses. Patient has a brother at home who had been COVID positive for 3 days but they have done the best to keep the patient isolated.  In the ambulance a temperature of 101.3° was noted. In the ED, his Covid PCR test was positive. He continued to have seizure activity refractory to IV ativan and Keppra IV. After discussions with neurology, the patient was intubated for airway protection and to help facilitate management of his status epilepticus. He was admitted to the ICU for management, on continuous EEG with propofol and versed gtts. Propofol weaned off 2/25 and versed weaned off 2/26 with no further signs of epileptiform activity on EEG. Sputum cx grew MSSA and Klebsiella, noted multiple drug reactions to abx, now maintained on levofloxacin. Patient was extubated to RA on 3/2.  Neurology was consulted for adjustments of antiseizure medications.  The patient was transferred to the general medical floor.  NG tube was removed and he was able to take all his oral meds.  The patient was discharged home with the family in a stable condition.
Age: 21.0
Sex: M
Vaccine: COVID19-2
Symptoms: Exposure to SARS-CoV-2, Gastrointestinal tube insertion, Intensive care, Klebsiella test positive, SARS-CoV-2 test positive
Clinical narrative: Discharge Provider: MD Primary Care Provider: MD Admission Date: 2/24/2023 Discharge Date: Mar 7, 2023  PRESENTING PROBLEM: Status epilepticus COVID-19  Seizure  Pneumonia due to Klebsiella pneumoniae    HOSPITAL COURSE: Patient is a 21 year old male with  a past medical history of CP, global DD, complex partial epilepsy on multiple AEDs who presented to emergency department on 2/24  with multiple witnessed seizures at home. Per mom, the patient last had seizures in September 2022. On day of arrival, she noted 2 seizures for which she gave him IM ativan x 2 doses. Patient has a brother at home who had been COVID positive for 3 days but they have done the best to keep the patient isolated.  In the ambulance a temperature of 101.3° was noted. In the ED, his Covid PCR test was positive. He continued to have seizure activity refractory to IV ativan and Keppra IV. After discussions with neurology, the patient was intubated for airway protection and to help facilitate management of his status epilepticus. He was admitted to the ICU for management, on continuous EEG with propofol and versed gtts. Propofol weaned off 2/25 and versed weaned off 2/26 with no further signs of epileptiform activity on EEG. Sputum cx grew MSSA and Klebsiella, noted multiple drug reactions to abx, now maintained on levofloxacin. Patient was extubated to RA on 3/2.  Neurology was consulted for adjustments of antiseizure medications.  The patient was transferred to the general medical floor.  NG tube was removed and he was able to take all his oral meds.  The patient was discharged home with the family in a stable condition.
Age: 21.0
Sex: M
Vaccine: COVID19-2
Symptoms: Seizure, Sputum culture positive, Staphylococcus test positive, Status epilepticus
Clinical narrative: Discharge Provider: MD Primary Care Provider: MD Admission Date: 2/24/2023 Discharge Date: Mar 7, 2023  PRESENTING PROBLEM: Status epilepticus COVID-19  Seizure  Pneumonia due to Klebsiella pneumoniae    HOSPITAL COURSE: Patient is a 21 year old male with  a past medical history of CP, global DD, complex partial epilepsy on multiple AEDs who presented to emergency department on 2/24  with multiple witnessed seizures at home. Per mom, the patient last had seizures in September 2022. On day of arrival, she noted 2 seizures for which she gave him IM ativan x 2 doses. Patient has a brother at home who had been COVID positive for 3 days but they have done the best to keep the patient isolated.  In the ambulance a temperature of 101.3° was noted. In the ED, his Covid PCR test was positive. He continued to have seizure activity refractory to IV ativan and Keppra IV. After discussions with neurology, the patient was intubated for airway protection and to help facilitate management of his status epilepticus. He was admitted to the ICU for management, on continuous EEG with propofol and versed gtts. Propofol weaned off 2/25 and versed weaned off 2/26 with no further signs of epileptiform activity on EEG. Sputum cx grew MSSA and Klebsiella, noted multiple drug reactions to abx, now maintained on levofloxacin. Patient was extubated to RA on 3/2.  Neurology was consulted for adjustments of antiseizure medications.  The patient was transferred to the general medical floor.  NG tube was removed and he was able to take all his oral meds.  The patient was discharged home with the family in a stable condition.
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired on 2/27/23.  No adverse events noted.
Age: 65.0
Sex: M
Vaccine: COVID19-2, FLUR4
Symptoms: COVID-19, Cough, Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I had body aches, cough, and slight fever of 100. I tested positive for COVID-19. I spoke to my doctor and we decided not to take PAXLOVID because my symptoms were clearing up on their own.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute kidney injury, Aspergillus infection, Bronchoscopy normal, COVID-19 pneumonia, Chest X-ray abnormal
Clinical narrative: Discharge Provider: MD Primary Care Provider: PA Admission Date: 2/24/2023 Discharge Date: 3/8/23+  PRESENTING PROBLEM: Pneumonia due to COVID-19 virus    HOSPITAL COURSE: Patient is a 68 yo female s/p bilateral lung transplant for COPD 4/2022 with Osteoporosis, esophageal dysmotility, CAD who became symptomatic with cough, fatigue and congestion 2/6/23. She did not opt for treatment at that time due to cost. She continued to have symptoms and assessed on 2/16 via telemedicne visit. Prendiosne 40 mg x 5 days, azithromycin 500 mg x 5 days were given and cellcept stopped. CXR indicated some new GGO. Follow up imaging was stable but since still symptomatic CT thorax ordered and indicated " There are multiple new peripheral and peribronchovascular patchy groundglass attenuations and interlobar septal thickening within the lower lungs compared to the prior study". She was admitted for treatment of COVID PNA.   During admission she improved symptomatically with treatment. Bronchoscopy was completed 2/25/23 to rule out additional infections. 2/28 fungal cultures initially positive for fungus with positive pan aspergillus. She was started on voriconzole the night of 2/28. Cultures updated to show both aspergillus Niger and fumigatus. Given she just completed treatment with voriconazole decision with consultation with ID made to switch to Cresemba and add Micafungin. ID has requested sensitivities from lab which will be pending for 2-3 weeks. Given improvement in symptoms, planned to continue Micafungin while inpatient and dc on Cresemba only.    Significant tenderness of maxillary sinus noted and CT ordered. CT sinus with air fluid levels and ENT consulted. Sinus cultures were negative but patient completed 7 day course of abx for sinusitis.    Throughout the stay, patient had mild AKI as well as hyperkalemia which improved by day of dc. She was also found to have low IGG levels, was given a dose of IVIG and will follow-up with immunology as an outpatient    Patient is being discharged home today to follow up in clinic in 2 weeks with repeat labs Monday.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Computerised tomogram thorax abnormal, Cough, Fatigue, Fungal test positive, Hyperkalaemia
Clinical narrative: Discharge Provider: MD Primary Care Provider: PA Admission Date: 2/24/2023 Discharge Date: 3/8/23+  PRESENTING PROBLEM: Pneumonia due to COVID-19 virus    HOSPITAL COURSE: Patient is a 68 yo female s/p bilateral lung transplant for COPD 4/2022 with Osteoporosis, esophageal dysmotility, CAD who became symptomatic with cough, fatigue and congestion 2/6/23. She did not opt for treatment at that time due to cost. She continued to have symptoms and assessed on 2/16 via telemedicne visit. Prendiosne 40 mg x 5 days, azithromycin 500 mg x 5 days were given and cellcept stopped. CXR indicated some new GGO. Follow up imaging was stable but since still symptomatic CT thorax ordered and indicated " There are multiple new peripheral and peribronchovascular patchy groundglass attenuations and interlobar septal thickening within the lower lungs compared to the prior study". She was admitted for treatment of COVID PNA.   During admission she improved symptomatically with treatment. Bronchoscopy was completed 2/25/23 to rule out additional infections. 2/28 fungal cultures initially positive for fungus with positive pan aspergillus. She was started on voriconzole the night of 2/28. Cultures updated to show both aspergillus Niger and fumigatus. Given she just completed treatment with voriconazole decision with consultation with ID made to switch to Cresemba and add Micafungin. ID has requested sensitivities from lab which will be pending for 2-3 weeks. Given improvement in symptoms, planned to continue Micafungin while inpatient and dc on Cresemba only.    Significant tenderness of maxillary sinus noted and CT ordered. CT sinus with air fluid levels and ENT consulted. Sinus cultures were negative but patient completed 7 day course of abx for sinusitis.    Throughout the stay, patient had mild AKI as well as hyperkalemia which improved by day of dc. She was also found to have low IGG levels, was given a dose of IVIG and will follow-up with immunology as an outpatient    Patient is being discharged home today to follow up in clinic in 2 weeks with repeat labs Monday.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Immunoglobulin therapy, Lung opacity, Pulmonary septal thickening, Respiratory tract congestion, Sinus pain
Clinical narrative: Discharge Provider: MD Primary Care Provider: PA Admission Date: 2/24/2023 Discharge Date: 3/8/23+  PRESENTING PROBLEM: Pneumonia due to COVID-19 virus    HOSPITAL COURSE: Patient is a 68 yo female s/p bilateral lung transplant for COPD 4/2022 with Osteoporosis, esophageal dysmotility, CAD who became symptomatic with cough, fatigue and congestion 2/6/23. She did not opt for treatment at that time due to cost. She continued to have symptoms and assessed on 2/16 via telemedicne visit. Prendiosne 40 mg x 5 days, azithromycin 500 mg x 5 days were given and cellcept stopped. CXR indicated some new GGO. Follow up imaging was stable but since still symptomatic CT thorax ordered and indicated " There are multiple new peripheral and peribronchovascular patchy groundglass attenuations and interlobar septal thickening within the lower lungs compared to the prior study". She was admitted for treatment of COVID PNA.   During admission she improved symptomatically with treatment. Bronchoscopy was completed 2/25/23 to rule out additional infections. 2/28 fungal cultures initially positive for fungus with positive pan aspergillus. She was started on voriconzole the night of 2/28. Cultures updated to show both aspergillus Niger and fumigatus. Given she just completed treatment with voriconazole decision with consultation with ID made to switch to Cresemba and add Micafungin. ID has requested sensitivities from lab which will be pending for 2-3 weeks. Given improvement in symptoms, planned to continue Micafungin while inpatient and dc on Cresemba only.    Significant tenderness of maxillary sinus noted and CT ordered. CT sinus with air fluid levels and ENT consulted. Sinus cultures were negative but patient completed 7 day course of abx for sinusitis.    Throughout the stay, patient had mild AKI as well as hyperkalemia which improved by day of dc. She was also found to have low IGG levels, was given a dose of IVIG and will follow-up with immunology as an outpatient    Patient is being discharged home today to follow up in clinic in 2 weeks with repeat labs Monday.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sinusitis
Clinical narrative: Discharge Provider: MD Primary Care Provider: PA Admission Date: 2/24/2023 Discharge Date: 3/8/23+  PRESENTING PROBLEM: Pneumonia due to COVID-19 virus    HOSPITAL COURSE: Patient is a 68 yo female s/p bilateral lung transplant for COPD 4/2022 with Osteoporosis, esophageal dysmotility, CAD who became symptomatic with cough, fatigue and congestion 2/6/23. She did not opt for treatment at that time due to cost. She continued to have symptoms and assessed on 2/16 via telemedicne visit. Prendiosne 40 mg x 5 days, azithromycin 500 mg x 5 days were given and cellcept stopped. CXR indicated some new GGO. Follow up imaging was stable but since still symptomatic CT thorax ordered and indicated " There are multiple new peripheral and peribronchovascular patchy groundglass attenuations and interlobar septal thickening within the lower lungs compared to the prior study". She was admitted for treatment of COVID PNA.   During admission she improved symptomatically with treatment. Bronchoscopy was completed 2/25/23 to rule out additional infections. 2/28 fungal cultures initially positive for fungus with positive pan aspergillus. She was started on voriconzole the night of 2/28. Cultures updated to show both aspergillus Niger and fumigatus. Given she just completed treatment with voriconazole decision with consultation with ID made to switch to Cresemba and add Micafungin. ID has requested sensitivities from lab which will be pending for 2-3 weeks. Given improvement in symptoms, planned to continue Micafungin while inpatient and dc on Cresemba only.    Significant tenderness of maxillary sinus noted and CT ordered. CT sinus with air fluid levels and ENT consulted. Sinus cultures were negative but patient completed 7 day course of abx for sinusitis.    Throughout the stay, patient had mild AKI as well as hyperkalemia which improved by day of dc. She was also found to have low IGG levels, was given a dose of IVIG and will follow-up with immunology as an outpatient    Patient is being discharged home today to follow up in clinic in 2 weeks with repeat labs Monday.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, COVID-19, Cardiac function test, Crying, Gait disturbance
Clinical narrative: After the 15 minutes, but within the hour of having the vaccine , I returned to my classroom to give a semester exam. On my way to the room, I stumbled a bit and used the wall to help me balance. When I sat down at my desk, I made sense to me, but not to anyone around me.  I don't remember, but the teacher next door said that I stumbled into her room, crying and babbling, but she had no idea what happened. The front office was called. EMS as well. I was admitted to the hospital  and two days later I woke up there with most of my memory restored. At the time, they tested my heart and my kidneys, but no one would test my brain.   I wasn't until I caught COVID last year and the same thing happened my brain last year that anyone took me seriously about COVID affecting my brain.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Incoherent, Memory impairment, Renal function test
Clinical narrative: After the 15 minutes, but within the hour of having the vaccine , I returned to my classroom to give a semester exam. On my way to the room, I stumbled a bit and used the wall to help me balance. When I sat down at my desk, I made sense to me, but not to anyone around me.  I don't remember, but the teacher next door said that I stumbled into her room, crying and babbling, but she had no idea what happened. The front office was called. EMS as well. I was admitted to the hospital  and two days later I woke up there with most of my memory restored. At the time, they tested my heart and my kidneys, but no one would test my brain.   I wasn't until I caught COVID last year and the same thing happened my brain last year that anyone took me seriously about COVID affecting my brain.
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: Alopecia, Alopecia areata, Biopsy, Chest discomfort, Condition aggravated
Clinical narrative: 1) Patient developed much worsening alopecia areata that went from 2 small spots on scalp to 75% of scalp hair loss within 2 months post-vaccination 2) Patient developed shortness of breath and tightness in chest within a few hours post-vaccination which persisted till this day (unresolved currently 3/9/23). Pulmonary Function Test in January 2023 revealed possible inflammation around lungs with diffusion defect.
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dyspnoea, Laboratory test normal, Pulmonary function test abnormal
Clinical narrative: 1) Patient developed much worsening alopecia areata that went from 2 small spots on scalp to 75% of scalp hair loss within 2 months post-vaccination 2) Patient developed shortness of breath and tightness in chest within a few hours post-vaccination which persisted till this day (unresolved currently 3/9/23). Pulmonary Function Test in January 2023 revealed possible inflammation around lungs with diffusion defect.
Age: 51.0
Sex: U
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: No adverse reaction - just caught Covid 5 months later
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Exposure to SARS-CoV-2, Headache, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: I was exposed and had a home test COVID-19 test and it was positive with mild symptoms, at the 3rd day I called my doctor and prescribed PAXLOVID, after 36 hours it was a better; I had headache, take aspirins, sore throat, I tested again on Saturday, Monday was Negative, and all symptoms were gone.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Blepharospasm, Brain scan abnormal, Cerebrovascular accident, Headache, Hypoaesthesia
Clinical narrative: Pt states she had and "extreme headache" the next morning while shopping in the store followed by right eye uncontrolled twitching and ride side face numbness for about 10 minutes.  She went to the hospital and was treated for a "stroke" then had a scan showing a 2-3 mm aneurysm.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Intracranial aneurysm
Clinical narrative: Pt states she had and "extreme headache" the next morning while shopping in the store followed by right eye uncontrolled twitching and ride side face numbness for about 10 minutes.  She went to the hospital and was treated for a "stroke" then had a scan showing a 2-3 mm aneurysm.
Sex: F
Vaccine: HEP
Symptoms: Alanine aminotransferase increased, Apnoea, Aspartate aminotransferase increased, Gastrooesophageal reflux disease, Hepatitis B DNA assay negative
Clinical narrative: Apnea/reflux noted on day of life 1-2.  At initial hospital follow-up visit parents reported significant apneic episodes at home with stridor.  Patient was admitted to the NICU and septic workup completed.  As part of workup ALT noted to be elevated to 445.  Hepatitis panel sent which was noted to be positive for Hep B sAg with s/co ratio 9.95, negative HBc IgM (8/17/22).  Mother's prenatal labs were negative for Hepatitis B and additional testing after delivery remained negative.  No transfusions or other blood sticks outside routine lab draw in the hospital for bilirubin level and newborn metabolic screen.  Hepatitis B viral DNA test on infant was negative (8/19/22).
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B core antibody negative, Hepatitis B surface antigen positive, Intensive care, Laboratory test, Sepsis
Clinical narrative: Apnea/reflux noted on day of life 1-2.  At initial hospital follow-up visit parents reported significant apneic episodes at home with stridor.  Patient was admitted to the NICU and septic workup completed.  As part of workup ALT noted to be elevated to 445.  Hepatitis panel sent which was noted to be positive for Hep B sAg with s/co ratio 9.95, negative HBc IgM (8/17/22).  Mother's prenatal labs were negative for Hepatitis B and additional testing after delivery remained negative.  No transfusions or other blood sticks outside routine lab draw in the hospital for bilirubin level and newborn metabolic screen.  Hepatitis B viral DNA test on infant was negative (8/19/22).
Sex: F
Vaccine: HEP
Symptoms: Stridor
Clinical narrative: Apnea/reflux noted on day of life 1-2.  At initial hospital follow-up visit parents reported significant apneic episodes at home with stridor.  Patient was admitted to the NICU and septic workup completed.  As part of workup ALT noted to be elevated to 445.  Hepatitis panel sent which was noted to be positive for Hep B sAg with s/co ratio 9.95, negative HBc IgM (8/17/22).  Mother's prenatal labs were negative for Hepatitis B and additional testing after delivery remained negative.  No transfusions or other blood sticks outside routine lab draw in the hospital for bilirubin level and newborn metabolic screen.  Hepatitis B viral DNA test on infant was negative (8/19/22).
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Fatigue, Myalgia, Oropharyngeal pain
Clinical narrative: That Friday night I had a runny nose, sore throat and I was coughing. All of that worsened on Saturday. On Sunday, I thought I might be better but I was really tired. My friend told me to test and I tested positive for COVID-19. I started taking PAXLOVID on Monday, and I was very exhausted and my muscles hurt for Monday through Wednesday (3 days). Also, another strange occurrence. I've traveled a few times and in security, they've had to check my arm where the vaccination was administered due to the metal detector. That has happened a few times now. Kind of strange.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: That Friday night I had a runny nose, sore throat and I was coughing. All of that worsened on Saturday. On Sunday, I thought I might be better but I was really tired. My friend told me to test and I tested positive for COVID-19. I started taking PAXLOVID on Monday, and I was very exhausted and my muscles hurt for Monday through Wednesday (3 days). Also, another strange occurrence. I've traveled a few times and in security, they've had to check my arm where the vaccination was administered due to the metal detector. That has happened a few times now. Kind of strange.
Age: 72.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Atrial fibrillation, Condition aggravated, Echocardiogram abnormal, Electrocardiogram abnormal, Epistaxis
Clinical narrative: Nosebleed, high blood pressure. Visit to ER, hospitalized 36 hours, , atrial fibrillation diagnosis; stabilized, nose pack, echocardiagram, medications,  eval by cardiologist, and medical team at Hospital.  Released to home with no activity restrictions. Contact with PCP, Nose pack removed by ENT 2 days later, appointment arranged with Cardiologist.
Age: 72.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Hypertension, Nasal cavity packing
Clinical narrative: Nosebleed, high blood pressure. Visit to ER, hospitalized 36 hours, , atrial fibrillation diagnosis; stabilized, nose pack, echocardiagram, medications,  eval by cardiologist, and medical team at Hospital.  Released to home with no activity restrictions. Contact with PCP, Nose pack removed by ENT 2 days later, appointment arranged with Cardiologist.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Bacterial infection, Dialysis, Hypotension, Intensive care, Loss of consciousness
Clinical narrative: I developed a severe multi-drug resistant urinary tract infection. It rendered me to be ventilated and dialyzed.  My blood pressure was very low, and I needed the Sepsis sorted out. I was in ICU for 8 days, 5 of them was ventilation. I was unconscious during the ventilation. I have had Dialysis since then. And now I am still on antibiotics and rehab after the stay in ICU.  This was from February 3 until the 20th of 2023.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Mechanical ventilation, Renal failure, Sepsis, Urinary tract infection
Clinical narrative: I developed a severe multi-drug resistant urinary tract infection. It rendered me to be ventilated and dialyzed.  My blood pressure was very low, and I needed the Sepsis sorted out. I was in ICU for 8 days, 5 of them was ventilation. I was unconscious during the ventilation. I have had Dialysis since then. And now I am still on antibiotics and rehab after the stay in ICU.  This was from February 3 until the 20th of 2023.
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Product use issue, Rubella antibody positive
Clinical narrative: MMR vaccine was ordered to be administered if the patient had a negative rubella titer.  The dose was administered despite a positive titer.  No harm to the patient.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I tested positive for COVID-19 on 02/28/2023 I woke up with a hard cough. I had a fever the first 2 days 101. I did sleep and cough for 5 days. My provider prescribed PAXLOVID for 5 day treatment.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Oropharyngeal discomfort, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: On December 6 I started having a raspy throat, I thought it was allergies. Two days later I thought it may be a cold so I went and bought some Zicam, sore throat lozenges. The next morning, I woke up feeling even worse, so I went to the local Urgent Care to find out what was going on. I was tested for COVID-19, it come back positive. I was prescribed Paxlovid and Benzonatate. I am feeling better, but I have been left with a constant feeling of needing to cough up something from my throat.
Age: 0.92
Sex: M
Vaccine: MNQ
Symptoms: No adverse event
Clinical narrative: There was no adverse event that has been reported by the family.
Age: 1.0
Sex: M
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered Gardasil 9 to a one year old patient.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event
Clinical narrative: No adverse effects noted after vaccination administered.
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Chills, Echocardiogram normal, Heart rate increased, Pyrexia
Clinical narrative: 1) That night after the vaccine I had chills and fever, and couldn't sleep  2) 4 days later i tested positive for Covid  3) 2 months after the shot and the Covid, I began experiencing tachycardia--- elevated heart rate, even sometimes when resting. I visited the doctor to check on my heart and there were no arrythmias and nothing abnormal she could find on an echocardiogram.
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Sleep disorder, Tachycardia
Clinical narrative: 1) That night after the vaccine I had chills and fever, and couldn't sleep  2) 4 days later i tested positive for Covid  3) 2 months after the shot and the Covid, I began experiencing tachycardia--- elevated heart rate, even sometimes when resting. I visited the doctor to check on my heart and there were no arrythmias and nothing abnormal she could find on an echocardiogram.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Chest discomfort, Cough, Ear infection, Exposure to SARS-CoV-2
Clinical narrative: I tested positive for COVID on February 4th, 2023. I got a notification on my phone that I had been in an area someone tested positive. I was given something for my cough, benzonatate 200 MG capsules after I went to urgent care. I was having chest pressure so I went to the ER, I developed over the weeks and ear and sinus infection. My doctor put ZPAK antibiotic. I started feeling much better after the antibiotics.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Sinusitis
Clinical narrative: I tested positive for COVID on February 4th, 2023. I got a notification on my phone that I had been in an area someone tested positive. I was given something for my cough, benzonatate 200 MG capsules after I went to urgent care. I was having chest pressure so I went to the ER, I developed over the weeks and ear and sinus infection. My doctor put ZPAK antibiotic. I started feeling much better after the antibiotics.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Headache
Clinical narrative: I stated having symptoms on 12/22/2022 like a cold. I had a scratchy throat, headache, congestion, cough, aches. On 12/24/2022 I then went to the urgent care and had a fever of 103 1/2. I also have some loss of taste and smell. The provider prescribed PAXLOVID for 5 day course.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nasopharyngitis, Pain, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I stated having symptoms on 12/22/2022 like a cold. I had a scratchy throat, headache, congestion, cough, aches. On 12/24/2022 I then went to the urgent care and had a fever of 103 1/2. I also have some loss of taste and smell. The provider prescribed PAXLOVID for 5 day course.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Throat irritation
Clinical narrative: I stated having symptoms on 12/22/2022 like a cold. I had a scratchy throat, headache, congestion, cough, aches. On 12/24/2022 I then went to the urgent care and had a fever of 103 1/2. I also have some loss of taste and smell. The provider prescribed PAXLOVID for 5 day course.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Gait disturbance, Pain in extremity, Walking aid user
Clinical narrative: 8 days later I had pain in my right knee and went up to my thigh. It got so bad that I had to get a cane because I could not walk on it. I went to the doctor and she did not know what it was. It took me about a month to recover.
Age: 29.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: No additional AE; patient received 2nd dose of GARDASIL 9 on 11/16/2022 when she was 2 weeks pregnant; This spontaneous report was received from a physician and refers to a 29-year-old female patient.  The patient's pertinent medical history, current conditions, drug reactions or allergies and concomitant medications were not reported. At the time of the adverse event occurrence, the patient was in the 2th pregnancy week. The patient's last menstrual period was estimated to be on 02-NOV-2022. The due date was estimated to be on 09-AUG-2023. The outcome of the pregnancy was pending at the time of the report.  On 16-NOV-2022, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 ml, lot #W001498, expiration date: 15-SEP-2024, administered for prophylaxis (strength, and route of administration were not provided) when she was 2 weeks pregnant (exposure during pregnancy). No additional adverse events details or product quality complaints were reported (no adverse event).
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Amenorrhoea, Breast tenderness, Disability, Hormone therapy
Clinical narrative: premature ovarian failure/insufficiency; infertility; Information has been received from a lawyer to a case in litigation and the patient's mother and refers and referring to a currently 12-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On 25-JUL-2017, when the patient was 9-years-old, the patient was vaccinated with a first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (lot #, expiration date, anatomical location, route and frequency were not reported) for prophylaxis.    On 25-JAN-2018 and 01-JUL-2018 the patient was vaccinated with a second and third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) respectively (lot #, expiration date, anatomical location, route and frequency were not reported) for prophylaxis.  On an unspecified date in April 2018, the patient reached puberty and began menstruating.  On an unspecified date in July 2018 (reported as "within three days of her third dosage of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL)"), the patient began to experience tenderness in her breast. Then, within four months, she experienced sweating, mood swings, and thinning and loss of hair.  In or around October 2020, the patient suddenly stopped menstruating (when she was 12-years-old); and her physician prescribed hormones for four months after her periods stopped to attempt to jumpstart her menstruation, but it failed to work. Later, when she was 13-years-old The physician determined that the patient was menopausal and diagnosed with premature ovarian failure/insufficiency and, as consequence, the patient must take estrogen and progesterone for the rest of her life.   The outcome of the events was not recovered. The reporter considered all the events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL).  All events were considered disabling since it was mentioned that the patient always dreamed of becoming a mother, and she will never be able to have children of her own.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Hyperhidrosis, Infertility female, Menopause, Menstrual disorder, Mood swings
Clinical narrative: premature ovarian failure/insufficiency; infertility; Information has been received from a lawyer to a case in litigation and the patient's mother and refers and referring to a currently 12-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On 25-JUL-2017, when the patient was 9-years-old, the patient was vaccinated with a first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (lot #, expiration date, anatomical location, route and frequency were not reported) for prophylaxis.    On 25-JAN-2018 and 01-JUL-2018 the patient was vaccinated with a second and third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) respectively (lot #, expiration date, anatomical location, route and frequency were not reported) for prophylaxis.  On an unspecified date in April 2018, the patient reached puberty and began menstruating.  On an unspecified date in July 2018 (reported as "within three days of her third dosage of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL)"), the patient began to experience tenderness in her breast. Then, within four months, she experienced sweating, mood swings, and thinning and loss of hair.  In or around October 2020, the patient suddenly stopped menstruating (when she was 12-years-old); and her physician prescribed hormones for four months after her periods stopped to attempt to jumpstart her menstruation, but it failed to work. Later, when she was 13-years-old The physician determined that the patient was menopausal and diagnosed with premature ovarian failure/insufficiency and, as consequence, the patient must take estrogen and progesterone for the rest of her life.   The outcome of the events was not recovered. The reporter considered all the events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL).  All events were considered disabling since it was mentioned that the patient always dreamed of becoming a mother, and she will never be able to have children of her own.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Ovarian failure, Premature menopause, Treatment failure
Clinical narrative: premature ovarian failure/insufficiency; infertility; Information has been received from a lawyer to a case in litigation and the patient's mother and refers and referring to a currently 12-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On 25-JUL-2017, when the patient was 9-years-old, the patient was vaccinated with a first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (lot #, expiration date, anatomical location, route and frequency were not reported) for prophylaxis.    On 25-JAN-2018 and 01-JUL-2018 the patient was vaccinated with a second and third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) respectively (lot #, expiration date, anatomical location, route and frequency were not reported) for prophylaxis.  On an unspecified date in April 2018, the patient reached puberty and began menstruating.  On an unspecified date in July 2018 (reported as "within three days of her third dosage of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL)"), the patient began to experience tenderness in her breast. Then, within four months, she experienced sweating, mood swings, and thinning and loss of hair.  In or around October 2020, the patient suddenly stopped menstruating (when she was 12-years-old); and her physician prescribed hormones for four months after her periods stopped to attempt to jumpstart her menstruation, but it failed to work. Later, when she was 13-years-old The physician determined that the patient was menopausal and diagnosed with premature ovarian failure/insufficiency and, as consequence, the patient must take estrogen and progesterone for the rest of her life.   The outcome of the events was not recovered. The reporter considered all the events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL).  All events were considered disabling since it was mentioned that the patient always dreamed of becoming a mother, and she will never be able to have children of her own.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had shingles twice after 2times I got the shot/Suspected vaccination failure; I had shingles twice; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 03-FEB-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had shingles twice after 2 times receiving the shot. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Still get breakouts. I have had the shots/Suspected vaccination failure; Still get breakouts; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a elderly patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (got them at 23 year and had them numerous time since).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 02-MAR-2023 Reporter's comment: This case was reported by a patient via interactive digital media The patient had the shots and still get breakouts.  Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the shot still got shingles/Suspected vaccination failure; Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 02-MAR-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The reporter reported that patient had the shot and still got shingles. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure; Came down with it,; Nerve pain was excruciating; luckily mild rash; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, post herpetic neuralgia and rash. On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown and the outcome of the post herpetic neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia and rash to be related to Shingles vaccine.     Additional Information: GSK receipt date: 02-Mar-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received the shots and still came down with shingles, luckily mild rash but the nerve pain was excruciating. Four months later still having nerve pain. The patient thought to be smart out there and get the shots. The patient hate to think what it would had been like if she/he had not had them. Additional Supportive Information: The follow up would not possible, as no contact, details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Have recurring like shingles/Suspected vaccination failure; Have recurring like shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 02-Mar-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient was lucky that received two different shots and still had recurring like shingles. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow up would not possible, as no contact, details were available. As it was not clear if patient had different shots was of same manufacturer or different, hence conservatively coded both as suspect.