chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood creatinine increased, Complement factor C3, Complement factor C4, Double stranded DNA antibody, Full blood count
Clinical narrative: Pt developed hematuria and foaminess in urine 4-5 days after second Pfizer vaccine. Was admitted to hospital on 5/15 with AKI Cr 3s, underwent kidney biopsy showing MPO+ ANCA vasculitis with background IgA nephropathy. Started on pulse steroids and Rituximab with improvement of kidney function. Creatinine had peaked to 4 now improving to 3.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Haematuria, IgA nephropathy, Metabolic function test, Ultrasound kidney, Urine abnormality
Clinical narrative: Pt developed hematuria and foaminess in urine 4-5 days after second Pfizer vaccine. Was admitted to hospital on 5/15 with AKI Cr 3s, underwent kidney biopsy showing MPO+ ANCA vasculitis with background IgA nephropathy. Started on pulse steroids and Rituximab with improvement of kidney function. Creatinine had peaked to 4 now improving to 3.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urine analysis, Urine protein/creatinine ratio
Clinical narrative: Pt developed hematuria and foaminess in urine 4-5 days after second Pfizer vaccine. Was admitted to hospital on 5/15 with AKI Cr 3s, underwent kidney biopsy showing MPO+ ANCA vasculitis with background IgA nephropathy. Started on pulse steroids and Rituximab with improvement of kidney function. Creatinine had peaked to 4 now improving to 3.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Biopsy kidney abnormal, Blood creatinine increased, Glomerulonephritis rapidly progressive
Clinical narrative: Pt developed hematuria and foaminess in urine 4-5 days after second Pfizer vaccine. Was admitted to hospital on 5/15 with AKI Cr 3s, underwent kidney biopsy showing MPO+ ANCA vasculitis with background IgA nephropathy. Started on pulse steroids and Rituximab with improvement of kidney function. Creatinine had peaked to 4 now improving to 3.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: REDNESS AND SWELLING AT INJECTION SITE APPROX 4-5 INCHES IN DIAMETER WAS ABOUT THE SIZE OF A QUARTER WHEN I WENT TO BED AND GREW LARGER OVER THE NEXT 24 HOURS AND REMAINED THAT SIZE FOR ABOUT 4 DAYS THEN SLOWLY WENT AWAY ABOUT A WEEK LATER.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Bundle branch block right, Chest pain, Chills, Dizziness
Clinical narrative: 7/2 /2021 - I received the second dose of Moderna. 7/3/2021 - I woke up with a headache, my headache became more serve after lunch time. In the afternoon, I got a chill with a fever around 101 Fahrenheit using temple touch thermometer. That night, I had a massive nose bleed (clumps of blood) which lasted for at least 2 hours. I never ever had that kind of nose bleed before. I felt lethargic after all that. 7/4/2021- around 2am, I woke up because I couldn't breath. I had to work really hard to take a breath. I had an abnormal chest pain every time I took a deep breath. I felt numb in both arms, dizzy and, foggy. I was up every few hours to catch a breath. 7/5/2021 ?  my headache became less serve, but my other symptoms didn't improve. I went to the clinic, the physician there called an ambulance. The EMTs performed EKG on me twice. Both times showed I had abnormal heart rhythms. I then went to the ER, they performed another EKG (same result). After a lot of tests, I was safe to go home. I was diagnosed with A Bundle Branch Blocked.  It's almost a year since my second dose of Moderna, my chest pain still comes and goes. I really hope there is away to help me get back to normal. I am 5 feet, 105lbs. I don't exercise. I do yoga and I like hiking. My chest pain hardly occurs when I go for long walks, but usually happened when I lay down. I have no health conditions prior to the second dose of Moderna. I hardly ever get sick. I do have allergies in Spring time and get hives when I ate too much seafood. I usually took Claritin for my allergies. I didn't take Claritin for about 2 months before receiving the second dose of Moderna. Before getting Covid-19 vaccines, I focused on eating healthy and avoid seafood for about 4 weeks before and after my shots. Even when I was in pain,  I didn't take any over-the-counter meds; one- I didn't know which med to take, two- I didn't want over-the-counter medicine to interfere with the work of the vaccine. I did NOT take any dietary supplements, herbal remedies, or other non-traditional/ alternative medicines before or after vaccination. I didn't have short-term illness or acute illnesses on the date of vaccination and up to 1 month prior to 7/2/2021.  I wasn't sick or had any kind of side effects after the first dose of Moderna.  I never tested positive for SARS-CoV-2. I didn?t get treatments for my heart condition because I can't afford it. I seeked help from the government program but got rejected. I would like to participate and contribute to modern medicine/health science.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram abnormal, Epistaxis, Feeling abnormal, Headache
Clinical narrative: 7/2 /2021 - I received the second dose of Moderna. 7/3/2021 - I woke up with a headache, my headache became more serve after lunch time. In the afternoon, I got a chill with a fever around 101 Fahrenheit using temple touch thermometer. That night, I had a massive nose bleed (clumps of blood) which lasted for at least 2 hours. I never ever had that kind of nose bleed before. I felt lethargic after all that. 7/4/2021- around 2am, I woke up because I couldn't breath. I had to work really hard to take a breath. I had an abnormal chest pain every time I took a deep breath. I felt numb in both arms, dizzy and, foggy. I was up every few hours to catch a breath. 7/5/2021 ?  my headache became less serve, but my other symptoms didn't improve. I went to the clinic, the physician there called an ambulance. The EMTs performed EKG on me twice. Both times showed I had abnormal heart rhythms. I then went to the ER, they performed another EKG (same result). After a lot of tests, I was safe to go home. I was diagnosed with A Bundle Branch Blocked.  It's almost a year since my second dose of Moderna, my chest pain still comes and goes. I really hope there is away to help me get back to normal. I am 5 feet, 105lbs. I don't exercise. I do yoga and I like hiking. My chest pain hardly occurs when I go for long walks, but usually happened when I lay down. I have no health conditions prior to the second dose of Moderna. I hardly ever get sick. I do have allergies in Spring time and get hives when I ate too much seafood. I usually took Claritin for my allergies. I didn't take Claritin for about 2 months before receiving the second dose of Moderna. Before getting Covid-19 vaccines, I focused on eating healthy and avoid seafood for about 4 weeks before and after my shots. Even when I was in pain,  I didn't take any over-the-counter meds; one- I didn't know which med to take, two- I didn't want over-the-counter medicine to interfere with the work of the vaccine. I did NOT take any dietary supplements, herbal remedies, or other non-traditional/ alternative medicines before or after vaccination. I didn't have short-term illness or acute illnesses on the date of vaccination and up to 1 month prior to 7/2/2021.  I wasn't sick or had any kind of side effects after the first dose of Moderna.  I never tested positive for SARS-CoV-2. I didn?t get treatments for my heart condition because I can't afford it. I seeked help from the government program but got rejected. I would like to participate and contribute to modern medicine/health science.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Laboratory test, Lethargy, Pain, Pyrexia
Clinical narrative: 7/2 /2021 - I received the second dose of Moderna. 7/3/2021 - I woke up with a headache, my headache became more serve after lunch time. In the afternoon, I got a chill with a fever around 101 Fahrenheit using temple touch thermometer. That night, I had a massive nose bleed (clumps of blood) which lasted for at least 2 hours. I never ever had that kind of nose bleed before. I felt lethargic after all that. 7/4/2021- around 2am, I woke up because I couldn't breath. I had to work really hard to take a breath. I had an abnormal chest pain every time I took a deep breath. I felt numb in both arms, dizzy and, foggy. I was up every few hours to catch a breath. 7/5/2021 ?  my headache became less serve, but my other symptoms didn't improve. I went to the clinic, the physician there called an ambulance. The EMTs performed EKG on me twice. Both times showed I had abnormal heart rhythms. I then went to the ER, they performed another EKG (same result). After a lot of tests, I was safe to go home. I was diagnosed with A Bundle Branch Blocked.  It's almost a year since my second dose of Moderna, my chest pain still comes and goes. I really hope there is away to help me get back to normal. I am 5 feet, 105lbs. I don't exercise. I do yoga and I like hiking. My chest pain hardly occurs when I go for long walks, but usually happened when I lay down. I have no health conditions prior to the second dose of Moderna. I hardly ever get sick. I do have allergies in Spring time and get hives when I ate too much seafood. I usually took Claritin for my allergies. I didn't take Claritin for about 2 months before receiving the second dose of Moderna. Before getting Covid-19 vaccines, I focused on eating healthy and avoid seafood for about 4 weeks before and after my shots. Even when I was in pain,  I didn't take any over-the-counter meds; one- I didn't know which med to take, two- I didn't want over-the-counter medicine to interfere with the work of the vaccine. I did NOT take any dietary supplements, herbal remedies, or other non-traditional/ alternative medicines before or after vaccination. I didn't have short-term illness or acute illnesses on the date of vaccination and up to 1 month prior to 7/2/2021.  I wasn't sick or had any kind of side effects after the first dose of Moderna.  I never tested positive for SARS-CoV-2. I didn?t get treatments for my heart condition because I can't afford it. I seeked help from the government program but got rejected. I would like to participate and contribute to modern medicine/health science.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: 7/2 /2021 - I received the second dose of Moderna. 7/3/2021 - I woke up with a headache, my headache became more serve after lunch time. In the afternoon, I got a chill with a fever around 101 Fahrenheit using temple touch thermometer. That night, I had a massive nose bleed (clumps of blood) which lasted for at least 2 hours. I never ever had that kind of nose bleed before. I felt lethargic after all that. 7/4/2021- around 2am, I woke up because I couldn't breath. I had to work really hard to take a breath. I had an abnormal chest pain every time I took a deep breath. I felt numb in both arms, dizzy and, foggy. I was up every few hours to catch a breath. 7/5/2021 ?  my headache became less serve, but my other symptoms didn't improve. I went to the clinic, the physician there called an ambulance. The EMTs performed EKG on me twice. Both times showed I had abnormal heart rhythms. I then went to the ER, they performed another EKG (same result). After a lot of tests, I was safe to go home. I was diagnosed with A Bundle Branch Blocked.  It's almost a year since my second dose of Moderna, my chest pain still comes and goes. I really hope there is away to help me get back to normal. I am 5 feet, 105lbs. I don't exercise. I do yoga and I like hiking. My chest pain hardly occurs when I go for long walks, but usually happened when I lay down. I have no health conditions prior to the second dose of Moderna. I hardly ever get sick. I do have allergies in Spring time and get hives when I ate too much seafood. I usually took Claritin for my allergies. I didn't take Claritin for about 2 months before receiving the second dose of Moderna. Before getting Covid-19 vaccines, I focused on eating healthy and avoid seafood for about 4 weeks before and after my shots. Even when I was in pain,  I didn't take any over-the-counter meds; one- I didn't know which med to take, two- I didn't want over-the-counter medicine to interfere with the work of the vaccine. I did NOT take any dietary supplements, herbal remedies, or other non-traditional/ alternative medicines before or after vaccination. I didn't have short-term illness or acute illnesses on the date of vaccination and up to 1 month prior to 7/2/2021.  I wasn't sick or had any kind of side effects after the first dose of Moderna.  I never tested positive for SARS-CoV-2. I didn?t get treatments for my heart condition because I can't afford it. I seeked help from the government program but got rejected. I would like to participate and contribute to modern medicine/health science.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Dyspnoea, Herpes zoster, Hot flush, Night sweats
Clinical narrative: Shingles onset and menstrual cycle abruptly stopped completely until May 2022 ( over a year later); also experienced night sweats and hot flashes for about 9 months before period returned over a year later; heart palpitations and difficulty breathing April 2022
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Shingles onset and menstrual cycle abruptly stopped completely until May 2022 ( over a year later); also experienced night sweats and hot flashes for about 9 months before period returned over a year later; heart palpitations and difficulty breathing April 2022
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis acneiform, Nodule, Rash pruritic, Rash vesicular, Tenderness
Clinical narrative: Itchy Blister rash on upper abdomen area right side, right hip, under upper left arm, lower left leg , right thumb, right side of back - one tender bump
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Dizziness, Dysarthria, Fall
Clinical narrative: very dizzy and fell ... speaking slurred, had to go to ER room
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging
Clinical narrative: very dizzy and fell ... speaking slurred, had to go to ER room
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Night sweats, Palpitations
Clinical narrative: high fever (>101), chills, shivering, headache, soreness at injection site, night sweats, heart palpations.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: high fever (>101), chills, shivering, headache, soreness at injection site, night sweats, heart palpations.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose normal, Blood lactic acid normal, Blood potassium decreased, COVID-19, Chest X-ray normal
Clinical narrative: Initially  patient was noted to be unresponsive by his girlfriend and with concern of overdosing on clonazepam EMS was called.  During the evaluation patient was found to be on the floor unresponsive initially and responded to sternal rub.  His girlfriend has given him a 20 mg of intranasal Narcan and EN route he was given 4 mg of Narcan from the EMS and brought to the emergency department. He was maintaining his airway with a GCS of around 9.     On presentation to ED patient was found to have BP 215/118 with respiratory distress RR 30 with SpO2 98% on room air.   Labs showed leukocytosis 13.1 with HB 13.1 with hypokalemia 3.4 with normal troponin/lactate/procalcitonin with glucose 148 with urine drug screen positive for benzodiazepine with negative serum drug screening.  Influenza/RSV screening negative. COVID-19 positive.   Chest x-ray negative for any acute cardiopulmonary process. CT head negative for any acute intracranial process.   EKG showed NSR with QTC 456.    Patient was admitted for Klonopin overdose with accelerated hypertension with COVID-19 infection.   Patient was given IV hydralazine, potassium and Haldol in ED.   However when patient came to the floor from ED, he was awake, alert and oriented x3.  As he feels good he did not want to stay in the hospital.  He signed AMA before my arrival to see him.   Patient left the hospital against medical advise.  Patient understands that by leaving the hospital, he is placing his health and safety in peril, and can result in disability or death.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram head normal, Drug screen negative, Drug screen positive, Electrocardiogram, Haemoglobin decreased
Clinical narrative: Initially  patient was noted to be unresponsive by his girlfriend and with concern of overdosing on clonazepam EMS was called.  During the evaluation patient was found to be on the floor unresponsive initially and responded to sternal rub.  His girlfriend has given him a 20 mg of intranasal Narcan and EN route he was given 4 mg of Narcan from the EMS and brought to the emergency department. He was maintaining his airway with a GCS of around 9.     On presentation to ED patient was found to have BP 215/118 with respiratory distress RR 30 with SpO2 98% on room air.   Labs showed leukocytosis 13.1 with HB 13.1 with hypokalemia 3.4 with normal troponin/lactate/procalcitonin with glucose 148 with urine drug screen positive for benzodiazepine with negative serum drug screening.  Influenza/RSV screening negative. COVID-19 positive.   Chest x-ray negative for any acute cardiopulmonary process. CT head negative for any acute intracranial process.   EKG showed NSR with QTC 456.    Patient was admitted for Klonopin overdose with accelerated hypertension with COVID-19 infection.   Patient was given IV hydralazine, potassium and Haldol in ED.   However when patient came to the floor from ED, he was awake, alert and oriented x3.  As he feels good he did not want to stay in the hospital.  He signed AMA before my arrival to see him.   Patient left the hospital against medical advise.  Patient understands that by leaving the hospital, he is placing his health and safety in peril, and can result in disability or death.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Hypokalaemia, Influenza virus test negative, Leukocytosis, Overdose
Clinical narrative: Initially  patient was noted to be unresponsive by his girlfriend and with concern of overdosing on clonazepam EMS was called.  During the evaluation patient was found to be on the floor unresponsive initially and responded to sternal rub.  His girlfriend has given him a 20 mg of intranasal Narcan and EN route he was given 4 mg of Narcan from the EMS and brought to the emergency department. He was maintaining his airway with a GCS of around 9.     On presentation to ED patient was found to have BP 215/118 with respiratory distress RR 30 with SpO2 98% on room air.   Labs showed leukocytosis 13.1 with HB 13.1 with hypokalemia 3.4 with normal troponin/lactate/procalcitonin with glucose 148 with urine drug screen positive for benzodiazepine with negative serum drug screening.  Influenza/RSV screening negative. COVID-19 positive.   Chest x-ray negative for any acute cardiopulmonary process. CT head negative for any acute intracranial process.   EKG showed NSR with QTC 456.    Patient was admitted for Klonopin overdose with accelerated hypertension with COVID-19 infection.   Patient was given IV hydralazine, potassium and Haldol in ED.   However when patient came to the floor from ED, he was awake, alert and oriented x3.  As he feels good he did not want to stay in the hospital.  He signed AMA before my arrival to see him.   Patient left the hospital against medical advise.  Patient understands that by leaving the hospital, he is placing his health and safety in peril, and can result in disability or death.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Procalcitonin normal, Respiratory distress, Respiratory syncytial virus test negative, SARS-CoV-2 test positive, Troponin normal
Clinical narrative: Initially  patient was noted to be unresponsive by his girlfriend and with concern of overdosing on clonazepam EMS was called.  During the evaluation patient was found to be on the floor unresponsive initially and responded to sternal rub.  His girlfriend has given him a 20 mg of intranasal Narcan and EN route he was given 4 mg of Narcan from the EMS and brought to the emergency department. He was maintaining his airway with a GCS of around 9.     On presentation to ED patient was found to have BP 215/118 with respiratory distress RR 30 with SpO2 98% on room air.   Labs showed leukocytosis 13.1 with HB 13.1 with hypokalemia 3.4 with normal troponin/lactate/procalcitonin with glucose 148 with urine drug screen positive for benzodiazepine with negative serum drug screening.  Influenza/RSV screening negative. COVID-19 positive.   Chest x-ray negative for any acute cardiopulmonary process. CT head negative for any acute intracranial process.   EKG showed NSR with QTC 456.    Patient was admitted for Klonopin overdose with accelerated hypertension with COVID-19 infection.   Patient was given IV hydralazine, potassium and Haldol in ED.   However when patient came to the floor from ED, he was awake, alert and oriented x3.  As he feels good he did not want to stay in the hospital.  He signed AMA before my arrival to see him.   Patient left the hospital against medical advise.  Patient understands that by leaving the hospital, he is placing his health and safety in peril, and can result in disability or death.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli, White blood cell count increased
Clinical narrative: Initially  patient was noted to be unresponsive by his girlfriend and with concern of overdosing on clonazepam EMS was called.  During the evaluation patient was found to be on the floor unresponsive initially and responded to sternal rub.  His girlfriend has given him a 20 mg of intranasal Narcan and EN route he was given 4 mg of Narcan from the EMS and brought to the emergency department. He was maintaining his airway with a GCS of around 9.     On presentation to ED patient was found to have BP 215/118 with respiratory distress RR 30 with SpO2 98% on room air.   Labs showed leukocytosis 13.1 with HB 13.1 with hypokalemia 3.4 with normal troponin/lactate/procalcitonin with glucose 148 with urine drug screen positive for benzodiazepine with negative serum drug screening.  Influenza/RSV screening negative. COVID-19 positive.   Chest x-ray negative for any acute cardiopulmonary process. CT head negative for any acute intracranial process.   EKG showed NSR with QTC 456.    Patient was admitted for Klonopin overdose with accelerated hypertension with COVID-19 infection.   Patient was given IV hydralazine, potassium and Haldol in ED.   However when patient came to the floor from ED, he was awake, alert and oriented x3.  As he feels good he did not want to stay in the hospital.  He signed AMA before my arrival to see him.   Patient left the hospital against medical advise.  Patient understands that by leaving the hospital, he is placing his health and safety in peril, and can result in disability or death.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Bacterial infection, Blood creatinine increased, Bradycardia, COVID-19
Clinical narrative: Pt presented to the ED with chief complaint of dyspnea.  Patient was recently admitted from 9/27/21-1/7/22 for diabetic foot infection with osteomyelitis requiring prolonged IV antibiotics and she had difficulty with placement due to homelessness. She was eventually discharged to home. Symptoms this presentation had been going on for a few days. She was noted to be bradycardic at home which is unusual for her. On presentation, patient was bradycardic and hypothermic. She was given IV fluids and started on broad spectrum antibiotics for sepsis. She tested positive for Covid-19 within the last week and again tested positive here. Troponin was normal. Creatinine was 2.9, up from 1.0 at last discharge. Patient required BiPAP. ID, cardiology, and nephrology were consulted. She was found to have ESBL UTI and MDR foot wounds.  Patient was placed on broad-spectrum antibiotics transitioned to Avycaz and vancomycin per Infectious Disease.  Patient is found to be fluid overloaded and Cardiology was consulted.  Patient was in a mild diastolic Congestive heart failure exacerbation.  Patient was diuresed well with Nephrology on board secondary to kidney injury and was transition to p.o. Bumex 1 mg daily upon discharge.   Patient was discharged on February 8, 2022 in stable condition.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Chest X-ray abnormal, Condition aggravated, Diabetic foot infection, Dyspnoea
Clinical narrative: Pt presented to the ED with chief complaint of dyspnea.  Patient was recently admitted from 9/27/21-1/7/22 for diabetic foot infection with osteomyelitis requiring prolonged IV antibiotics and she had difficulty with placement due to homelessness. She was eventually discharged to home. Symptoms this presentation had been going on for a few days. She was noted to be bradycardic at home which is unusual for her. On presentation, patient was bradycardic and hypothermic. She was given IV fluids and started on broad spectrum antibiotics for sepsis. She tested positive for Covid-19 within the last week and again tested positive here. Troponin was normal. Creatinine was 2.9, up from 1.0 at last discharge. Patient required BiPAP. ID, cardiology, and nephrology were consulted. She was found to have ESBL UTI and MDR foot wounds.  Patient was placed on broad-spectrum antibiotics transitioned to Avycaz and vancomycin per Infectious Disease.  Patient is found to be fluid overloaded and Cardiology was consulted.  Patient was in a mild diastolic Congestive heart failure exacerbation.  Patient was diuresed well with Nephrology on board secondary to kidney injury and was transition to p.o. Bumex 1 mg daily upon discharge.   Patient was discharged on February 8, 2022 in stable condition.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Homeless, Hypervolaemia, Hypothermia, Left ventricular failure, Lung opacity
Clinical narrative: Pt presented to the ED with chief complaint of dyspnea.  Patient was recently admitted from 9/27/21-1/7/22 for diabetic foot infection with osteomyelitis requiring prolonged IV antibiotics and she had difficulty with placement due to homelessness. She was eventually discharged to home. Symptoms this presentation had been going on for a few days. She was noted to be bradycardic at home which is unusual for her. On presentation, patient was bradycardic and hypothermic. She was given IV fluids and started on broad spectrum antibiotics for sepsis. She tested positive for Covid-19 within the last week and again tested positive here. Troponin was normal. Creatinine was 2.9, up from 1.0 at last discharge. Patient required BiPAP. ID, cardiology, and nephrology were consulted. She was found to have ESBL UTI and MDR foot wounds.  Patient was placed on broad-spectrum antibiotics transitioned to Avycaz and vancomycin per Infectious Disease.  Patient is found to be fluid overloaded and Cardiology was consulted.  Patient was in a mild diastolic Congestive heart failure exacerbation.  Patient was diuresed well with Nephrology on board secondary to kidney injury and was transition to p.o. Bumex 1 mg daily upon discharge.   Patient was discharged on February 8, 2022 in stable condition.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Osteomyelitis, Pathogen resistance, Pneumonia, Polyuria, Positive airway pressure therapy
Clinical narrative: Pt presented to the ED with chief complaint of dyspnea.  Patient was recently admitted from 9/27/21-1/7/22 for diabetic foot infection with osteomyelitis requiring prolonged IV antibiotics and she had difficulty with placement due to homelessness. She was eventually discharged to home. Symptoms this presentation had been going on for a few days. She was noted to be bradycardic at home which is unusual for her. On presentation, patient was bradycardic and hypothermic. She was given IV fluids and started on broad spectrum antibiotics for sepsis. She tested positive for Covid-19 within the last week and again tested positive here. Troponin was normal. Creatinine was 2.9, up from 1.0 at last discharge. Patient required BiPAP. ID, cardiology, and nephrology were consulted. She was found to have ESBL UTI and MDR foot wounds.  Patient was placed on broad-spectrum antibiotics transitioned to Avycaz and vancomycin per Infectious Disease.  Patient is found to be fluid overloaded and Cardiology was consulted.  Patient was in a mild diastolic Congestive heart failure exacerbation.  Patient was diuresed well with Nephrology on board secondary to kidney injury and was transition to p.o. Bumex 1 mg daily upon discharge.   Patient was discharged on February 8, 2022 in stable condition.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary oedema, SARS-CoV-2 test positive, Sepsis, Superinfection, Troponin normal
Clinical narrative: Pt presented to the ED with chief complaint of dyspnea.  Patient was recently admitted from 9/27/21-1/7/22 for diabetic foot infection with osteomyelitis requiring prolonged IV antibiotics and she had difficulty with placement due to homelessness. She was eventually discharged to home. Symptoms this presentation had been going on for a few days. She was noted to be bradycardic at home which is unusual for her. On presentation, patient was bradycardic and hypothermic. She was given IV fluids and started on broad spectrum antibiotics for sepsis. She tested positive for Covid-19 within the last week and again tested positive here. Troponin was normal. Creatinine was 2.9, up from 1.0 at last discharge. Patient required BiPAP. ID, cardiology, and nephrology were consulted. She was found to have ESBL UTI and MDR foot wounds.  Patient was placed on broad-spectrum antibiotics transitioned to Avycaz and vancomycin per Infectious Disease.  Patient is found to be fluid overloaded and Cardiology was consulted.  Patient was in a mild diastolic Congestive heart failure exacerbation.  Patient was diuresed well with Nephrology on board secondary to kidney injury and was transition to p.o. Bumex 1 mg daily upon discharge.   Patient was discharged on February 8, 2022 in stable condition.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection, Wound
Clinical narrative: Pt presented to the ED with chief complaint of dyspnea.  Patient was recently admitted from 9/27/21-1/7/22 for diabetic foot infection with osteomyelitis requiring prolonged IV antibiotics and she had difficulty with placement due to homelessness. She was eventually discharged to home. Symptoms this presentation had been going on for a few days. She was noted to be bradycardic at home which is unusual for her. On presentation, patient was bradycardic and hypothermic. She was given IV fluids and started on broad spectrum antibiotics for sepsis. She tested positive for Covid-19 within the last week and again tested positive here. Troponin was normal. Creatinine was 2.9, up from 1.0 at last discharge. Patient required BiPAP. ID, cardiology, and nephrology were consulted. She was found to have ESBL UTI and MDR foot wounds.  Patient was placed on broad-spectrum antibiotics transitioned to Avycaz and vancomycin per Infectious Disease.  Patient is found to be fluid overloaded and Cardiology was consulted.  Patient was in a mild diastolic Congestive heart failure exacerbation.  Patient was diuresed well with Nephrology on board secondary to kidney injury and was transition to p.o. Bumex 1 mg daily upon discharge.   Patient was discharged on February 8, 2022 in stable condition.
Sex: U
Vaccine: COVID19, PPV
Symptoms: Illness, SARS-CoV-2 test
Clinical narrative: got reallysick; This spontaneous report was received from ther patient's wife referring to a male consumer of unknown age. The patient's concurrent conditions included cancer that was managed with unspecified chemotherapy. The patient's historical and concomitant medication and medical history were not reported.      On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) for prophylaxis (dose, route of administration, lot number and expiration date not reported). On 14-APR-2021, the patient was vaccinated with elasomeran(MODERNA COVID-19 VACCINE) (dose, reoute of administration, lot number and expiration date not reported) for prophylaxis too.     On 22-JAN-2022, the patient had a PCR for covid-19 that had a negative result for antibodies.   In January 2022, the patient got really sick (illness).      In April-2022, another PCR for covid-19 was done, however, the result was positive for antibodies present.  The outcome of illness and its causal relationship with the vaccins were not reported.
Age: 1.08
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Gait disturbance, Weight bearing difficulty
Clinical narrative: the patient has had difficulty walking; patient has not wanted to bear weight on lower extremities; This spontaneous report has been received from a nurse prescriber, concerning a 13-month-old male patient. The patient's drug reactions or allergies, medical history, and concurrent conditions were not provided. The patient's concomitant therapies included cetirizine hydrochloride (ZYRTEC).   On 04-MAY-2022, patient was vaccinated with 0.5 milliliters (mL) of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (rHA) (M-M-R II) injection (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number T037029, which has been verified to be valid, expiration date reported and validated as 03-NOV-2022), as prophylaxis. On the same date, he received 0.5 mL of hib vaccine conj (tet tox) (HIBERIX) injection (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number U015845, which has been verified to be non-valid (non-company lot number), expiration date reported as 01-APR-2023), as prophylaxis. Also, varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number U015845, which has been verified to be to be valid, upon internal review the expiration date was reported as 21-SEP-2023 but, validated as 19-MAY-2033) as prophylaxis.   On 04-MAY-2022 (since administration), the patient had had difficulty walking (Walking difficulty), has not wanted to bear weight on lower extremities (Weight bearing difficulty), and defaults to crawling after walking attempts. No treatment was given for the adverse events. Patient had sought medical attention. At the reporting time, patient had not recovered from the events.   The action taken with suspect vaccines regarding the events was considered as not applicable.   The causal relationship between suspect vaccines and the events was not provided
Age: 1.5
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE reported; During temperature excursion case, customer reported that improperly stored vaccine was administered to 10 separate patients.; This spontaneous report was received from an office manager referring to an 18-month-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.   On 03-MAY-2022, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot #T042013, expiration date: 22-JUL-2023 (strength, dose and route of administration were not provided) for prophylaxis (product storage error). No additional adverse event (AE) reported.  The administered dose of the vaccine experienced a temperature excursion in 11.43 degrees Celsius (C) for 4 hours and 45 minutes. There was no previous temperature excursion.   This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2205USA003131: US-009507513-2205USA002848: US-009507513-2205USA002913: US-009507513-2205USA002951: US-009507513-2205USA002965: US-009507513-2205USA002988: US-009507513-2205USA003043: US-009507513-2205USA003121: US-009507513-2205USA003266:
Age: 0.08
Sex: U
Vaccine: RV5
Symptoms: Medication error, No adverse event, Poor quality product administered, Product container seal issue
Clinical narrative: patient did not have any adverse effects or symptoms; Caller is a nurse who reports that she has a box of ROTATEQ in which the foil pouches containing ROTATEQ are unsealed. Three doses have been given out of that box; the caller does not know whether the foil pouches containing the administered doses we; Caller is a nurse who reports that she has a box of ROTATEQ in which the foil pouches containing ROTATEQ are unsealed. Three doses have been given out of that box; the caller does not know whether the foil pouches containing the administered doses we; the caller does not know whether the foil pouches containing the administered doses were also unsealed; This spontaneous report was received from a registered nurse referring to a 7 weeks old patient of unknown gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.    On 06-APR-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (lot # 1742077, expiration date 12-SEP-2022, 2 milliliter, oral) for prophylaxis. A box of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) in which the foil pouches containing rotavirus vaccine, live, oral, pentavalent(ROTATEQ) were unsealed, the dose had been given out of that box, the reporter did not know whether the foil pouches containing the administered dose was also unsealed (poor quality product administered, product container seal issue and circumstance or information capable of leading to medication error). The open pouches were not noticed until 11-MAY-2022. The patient did not have any adverse effects or symptoms following administration of the vaccine.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA003333: US-009507513-2205USA003247:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided. On 06-MAY-2022, the patient was vaccinated with a dose of an expired Hepatitis A Vaccine, Inactivated (VAQTA) for prophylaxis, lot number #U003464 and expiration date 02-MAY-2022 (strength, dose, frequency and route of administration were not reported).   No adverse events were reported.  This is one of 2 reports received from the same reporter (MARRS #US-009507513-2205USA003680) ; Sender's Comments:  US-009507513-2205USA003680:Case Number: 02164360
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Immunization Coordinator reporting administered improperly stored GARDASIL 9, Temperature above 46F (48F); This spontaneous report has been received from an unspecified reporter, concerning a 13-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.   On 04-MAY-2022, the patient was vaccinated with an one improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) prefilled syringe, for prophylaxis, lot number reported as T028929 and expiration date 08-MAR-2023 (anatomical location, exact dose, frequency and route of adminstration were not provided).   The temperature excursion was above of 46 Fahrenheit (F) (48F), during a time frame of 2 hours, 3 minutes and 0 seconds. There were previous temperature excursions reported as follows: 3 hours, 36 minutes, 0 seconds at 34F degrees; 6 hours, 4 minutes, 0 seconds at 34F degrees; 0 hours, 23 minutes, 0 seconds at 34.3F degrees; 0 hours, 21 minutes, 0 seconds at 34.3F degrees; 0 hours, 22 minutes, 0 seconds, at 34.3F degrees; 0 hours, 18 minutes, 0 seconds, at 34.5F degrees; 0 hours, 19 minutes, 0 seconds at 34.7F degrees; 0 hours, 5 minutes, 0 seconds at 34.3F degrees; 0 hours, 18 minutes, 0 seconds at 34.3F degrees; 0 hours, 16 minutes, 0 seconds at 34.9F degrees; 0 hours, 19 minutes, 0 seconds at 34.7F; and (33.1F) degrees for a time frame of 7 hours, 31 minutes and 0 seconds.
Sex: U
Vaccine: MMRV, UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details; The excursion occurred on May 12th and vaccine have been administered to an uknown amount of patients since then; This spontaneous report was received from a consumer referring to unspecified number of patients of unknown age and gender. The patients medical history, concomitant therapies and concurrent conditions were not reported.  On 12-MAY-2022, the following varicella virus vaccine live (oka/merck) (VARIVAX) vaccine's lot numbers: T020651 with expiration date 16-JUN-2022, T041687 with expiration date 10-DEC-2022, U022321 with expiration date 15-JUL-2023, U025789 with expiration date 19-AUG-2023 , U029621 with expiration date 22-SEP-2022, and U002398 with expiration date 22-JAN-2023,; sterile diluent (DILUENT MRK) (lot# and expiration date were not provided); and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant Human albumin (rHA) (PROQUAD) vaccine's lot number W006596 with expiration date 23-AUG-2023,  underwent a temperature excursion of -10 degree Celsius (°C) up to 8°C (average temperature -7.9°C) for 6 hours and 25 minutes (Product storage error). There was no previous temperature excursion..  On unspecified date in May 2022 (reported as "since the temperature excursion"),an unknown amount of patients were vaccinated with the reported lot number of  varicella virus vaccine live (oka/merck) (VARIVAX) (dosage regimen, route of administration and anatomical location were not provided), (strength, dose, route of administration and anatomical location were not provided); ; sterile diluent (DILUENT MRK); and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) vaccine ( lot number W006596 with expiration date 23-AUG-2023) (dosage regimen, route of administration and anatomical location were not provided). Both suspect vaccines were administered for prophylaxis.  No adverse events (AE) were reported, and no further information was provided.  It was unknown if all lot numbers had been administered or how many from each lot number.  This is a non-valid report due to referred to an unspecified number of patients and no patient's identifier provided
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported.; Patient was accidently administered an expired dose of MMR II on 17-MAY-2022. Product expired on 11-MAY-2022.; This spontaneous report has been received from a licensed vocational nurse, concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.  On 17-MAY-2022, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant human albumin (rHA)) (M-M-R II) at a frequency reported as once, for prophylaxis (dose, vaccination scheme, route of administration, and anatomical site of injection were not reported; lot number T016196, that was verified to be a valid lot number with an expiration date reported and established as 11-MAY-2022) (expired product administered).   No additional adverse event (AE) was reported (no adverse event). The product had no prior temperature excursions.
Age: 0.17
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional AE reported; Nurse called to report "vaccine error." She stated 2 month old patient was administered PNEUMOVAX 23.; Patient was intended to receive PREVENAR 13; This spontaneous report has been received from a nurse referring a 9-week-old female patient.  The patient's pertinent medical history, previous drugs reactions or allergies and concomitant medications were not reported.  On 11-MAY-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) at a dose of 0.5milliliter once, lot number U021995, expiration date: 13-JAN-2023, administered as prophylaxis (route and site of administration were not provided) ; the patient was intended to receive pneumococcal vaccine conj 13v (CRM197) (PREVNAR 13) (product administered to patient of inappropriate age, wrong vaccine administered). No additional adverse event was reported.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Blindness, Seizure
Clinical narrative: Adverse Event Reported: "a host of serious health issues including: daily seizures, convulsions, and vision loss."; Adverse Event Reported: "a host of serious health issues including: daily seizures, convulsions, and vision loss."; Initial report obtained from a social media (SM) site, received from a consumer, regarding a case in litigation concerning a 22-year-old (adult (inconsistent information as it was also reported as a teenager)) female patient. On an unknown date (reported as a teenager), the patient was vaccinated with vaccine was quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) or hpv rL1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (reported as the company human papilloma virus (HPV) vaccine) as prophylaxis (exact dose, vaccination schedule, route of administration, lot number and expiration date were not provided). The reporter states that the patient had a host of serious health issues including daily seizures, convulsions, and vision loss (also reported as developed side effects) from the HPV vaccine. The outcome of the events was not provided. The claimed events were considered related to the HPV vaccine.  This case was considered non-valid due to lack of patient's identifiers.
Age: 0.17
Sex: M
Vaccine: PPV
Symptoms: Irritability, No adverse event, Product administered to patient of inappropriate age, Pyrexia, Restlessness
Clinical narrative: Cranky; Restless; Ran a fever; Restless; Ran a fever; Cranky; Restless; Cranky; Ran a fever; Receive the vaccine before the recommended age of 2 years old; Cranky; Restless; Ran a fever; This spontaneous report has been received from the patient's mother concerning her currently 15-year-old male son.  The patient's concurrent conditions, pertinent medical history, and historical drugs were not reported. Concomitant medications included hepatitis b vaccine (recombinant) (manufacturer unknown), diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (DTAP VACCINE), and Haemophilus influenzae type b (HIB) vaccine (manufacturer unknown).   On an unknown date in February 2007, when the patient was 2-month-old, he was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) multiple single doses, full dose (dose, anatomical location, lot number, expiration date, and route of administration were not provided) as vaccination (Product administered to patient of inappropriate age). On unspecified dates in April 2007 (reported as "at 4 months old"), in June 2007 (reported as "at 6 months old"), and then again in February 2009 (reported as "at 26 months old"), the patient received the second, third, and fourth doses of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) multiple single doses, respectively (exact doses, lot numbers, expiration dates, and routes of administration were not provided).  It was reported that after each vaccination, the patient became cranky (irritability), restless (restlessness), and experienced fever (pyrexia). The reporter inquired if there were any serious side effects for someone who receive the vaccine before the recommended age of 2 years old.  At the time of reporting, the outcome of all events was recovered. The causal relationship between all events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.