chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Injection site discolouration, Injection site pain, Injection site swelling, Laboratory test
Clinical narrative: I returned to the doctors office a day or so later with headache, swelling and discoloration at injection site, fever, chills, severe pain in left arm where injection was given.  The dr sent me for a chest x-ray the same day as my return visit.  Then told me that I had pneumonia.  Was given injections and had 3 return visits that week. Over the next couple of months I noticed an increase in respiratory problems. In September was told that I have several respiratory diseases.  Have been declining in health rapidly.  Now even when I just set up or stand my SpO2 declines into the upper  70 or low 80.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Oxygen saturation decreased, Pneumonia, Pyrexia, Respiratory disorder
Clinical narrative: I returned to the doctors office a day or so later with headache, swelling and discoloration at injection site, fever, chills, severe pain in left arm where injection was given.  The dr sent me for a chest x-ray the same day as my return visit.  Then told me that I had pneumonia.  Was given injections and had 3 return visits that week. Over the next couple of months I noticed an increase in respiratory problems. In September was told that I have several respiratory diseases.  Have been declining in health rapidly.  Now even when I just set up or stand my SpO2 declines into the upper  70 or low 80.
Age: 25.0
Sex: M
Vaccine: PPV, PPV
Symptoms: CSF pressure increased, CSF test normal, Computerised tomogram head normal, Headache, Injection site erythema
Clinical narrative: Chills, body aches, subjective fever, 'cold sweats', chest discomfort, SOB, redness at vaccine site, increased WBC 31.5 K/cmm, emesis.
Age: 25.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Intracranial pressure increased, Leukocytosis, Myalgia, White blood cell count increased
Clinical narrative: Chills, body aches, subjective fever, 'cold sweats', chest discomfort, SOB, redness at vaccine site, increased WBC 31.5 K/cmm, emesis.
Age: 25.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Chest discomfort, Chills, Cold sweat, Computerised tomogram head, Dyspnoea
Clinical narrative: Chills, body aches, subjective fever, 'cold sweats', chest discomfort, SOB, redness at vaccine site, increased WBC 31.5 K/cmm, emesis.
Age: 25.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Lumbar puncture, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Pain
Clinical narrative: Chills, body aches, subjective fever, 'cold sweats', chest discomfort, SOB, redness at vaccine site, increased WBC 31.5 K/cmm, emesis.
Age: 25.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pyrexia, Vomiting, White blood cell count increased
Clinical narrative: Chills, body aches, subjective fever, 'cold sweats', chest discomfort, SOB, redness at vaccine site, increased WBC 31.5 K/cmm, emesis.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Tinnitus
Clinical narrative: Tinnitus.
Age: 1.38
Sex: F
Vaccine: HIBV, PNC
Symptoms: Blister, Dermatitis diaper, Diarrhoea, Haemorrhage, Pain
Clinical narrative: When she woke up, she had a slight fever, about 100.5 F. Shortly after that, it spiked to 104.1. I gave her Tylenol and Motrin, and it brought it down to 103.5. For the next 24 hours, her temperature did not get below 103.5. On 6/1/14, she was awake all night, and I changed her diaper around 3 am. At 8 am, she had blisters covering her diaper area. It was red and very irritated on the small amount of skin that wasn't covered by fluid filled blisters. She has had diaper rashes after each previous vaccine she has had, but never this bad. She had some loose stools the day before, but they were never left on her skin, and she had no stools overnight that would cause such a reaction. We use the same diapers, so she is not having an allergic reaction. Today, 6/2/14, her buttocks are bleeding and oozing. She is in excruciating pain, and screams through each diaper change, every 30 minutes or so. Her fever did decrease to normal yesterday afternoon.
Age: 1.38
Sex: F
Vaccine: HIBV, PNC
Symptoms: Pyrexia, Screaming
Clinical narrative: When she woke up, she had a slight fever, about 100.5 F. Shortly after that, it spiked to 104.1. I gave her Tylenol and Motrin, and it brought it down to 103.5. For the next 24 hours, her temperature did not get below 103.5. On 6/1/14, she was awake all night, and I changed her diaper around 3 am. At 8 am, she had blisters covering her diaper area. It was red and very irritated on the small amount of skin that wasn't covered by fluid filled blisters. She has had diaper rashes after each previous vaccine she has had, but never this bad. She had some loose stools the day before, but they were never left on her skin, and she had no stools overnight that would cause such a reaction. We use the same diapers, so she is not having an allergic reaction. Today, 6/2/14, her buttocks are bleeding and oozing. She is in excruciating pain, and screams through each diaper change, every 30 minutes or so. Her fever did decrease to normal yesterday afternoon.
Age: 18.0
Sex: F
Vaccine: HPVX
Symptoms: Convulsion, Eye movement disorder, Posture abnormal
Clinical narrative: Patient's head went back and her eyes rolled back as she started to slide down off the table and then she started to seize. Very clammy and no color. No memory of what happened. After seizure had nausea, was dizzy and had a headache. This was directly after receiving the 3rd HPV vaccine. Was given juice to boost sugar level and cold compresses for the neck and head.
Age: 56.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Antibody test, Blood test, CSF test, Chronic inflammatory demyelinating polyradiculoneuropathy, Electrocardiogram
Clinical narrative: I was administered the new H1N1 vaccine on 9/23/2009 in the company of a friend. It was administered by Pharmacy manager, who had recently been trained to administer the vaccine. By 9/27/2009, I had begun suddenly stumbling, tripping and falling hard onto concrete without warning. My walking began to weave and I was tripping over every little crevice on the sidewalks. At the same time, I began to have unexpected bicycle crashes. I experienced tingling in my feet and lower legs. Within a few days I saw my primary physician, who noticed an absence of nerve response in my left leg. He referred me to a neurologist. Neurology Dept. chair, conducted extensive nerve tests, including my first EMG. He conducted extensive blood workups and ordered a sample of my spinal fluid, which as clear. Recognizing increasing loss of distal nerve response, Dr. issued a diagnosis of Guillain-Barre Syndrome. He later refined that diagnosis to Chronic Inflammatory Demyelinating Polyneuropathy and put me on a regime of Immuran. Dr. ordered quarterly IVIG infusions (five days each sequence). I moved in 2010, whereupon another doctor refined the diagnosis to CIDP with anti-MAG.
Age: 56.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Electromyogram, Fall, Gait disturbance, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: I was administered the new H1N1 vaccine on 9/23/2009 in the company of a friend. It was administered by Pharmacy manager, who had recently been trained to administer the vaccine. By 9/27/2009, I had begun suddenly stumbling, tripping and falling hard onto concrete without warning. My walking began to weave and I was tripping over every little crevice on the sidewalks. At the same time, I began to have unexpected bicycle crashes. I experienced tingling in my feet and lower legs. Within a few days I saw my primary physician, who noticed an absence of nerve response in my left leg. He referred me to a neurologist. Neurology Dept. chair, conducted extensive nerve tests, including my first EMG. He conducted extensive blood workups and ordered a sample of my spinal fluid, which as clear. Recognizing increasing loss of distal nerve response, Dr. issued a diagnosis of Guillain-Barre Syndrome. He later refined that diagnosis to Chronic Inflammatory Demyelinating Polyneuropathy and put me on a regime of Immuran. Dr. ordered quarterly IVIG infusions (five days each sequence). I moved in 2010, whereupon another doctor refined the diagnosis to CIDP with anti-MAG.
Age: 56.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Nerve stimulation test abnormal, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain, Paraesthesia, Waldenstrom's macroglobulinaemia
Clinical narrative: I was administered the new H1N1 vaccine on 9/23/2009 in the company of a friend. It was administered by Pharmacy manager, who had recently been trained to administer the vaccine. By 9/27/2009, I had begun suddenly stumbling, tripping and falling hard onto concrete without warning. My walking began to weave and I was tripping over every little crevice on the sidewalks. At the same time, I began to have unexpected bicycle crashes. I experienced tingling in my feet and lower legs. Within a few days I saw my primary physician, who noticed an absence of nerve response in my left leg. He referred me to a neurologist. Neurology Dept. chair, conducted extensive nerve tests, including my first EMG. He conducted extensive blood workups and ordered a sample of my spinal fluid, which as clear. Recognizing increasing loss of distal nerve response, Dr. issued a diagnosis of Guillain-Barre Syndrome. He later refined that diagnosis to Chronic Inflammatory Demyelinating Polyneuropathy and put me on a regime of Immuran. Dr. ordered quarterly IVIG infusions (five days each sequence). I moved in 2010, whereupon another doctor refined the diagnosis to CIDP with anti-MAG.
Age: 76.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Asthenia, Azotaemia, Blood creatinine increased, Blood lactate dehydrogenase increased, Blood urea increased
Clinical narrative: This medically confirmed literature case (initial receipt 20-May-2014) concerns a 76 year old male patient. On an unspecified date, the patient received a influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date after the flu vaccine, the patient presented with a one week history of generalised weakness and an unsteady gait. He had two episodes of non-bloody diarrhoea and decreased urine output. On physical examination, the patient was confused, lethargic and had dry mucous membranes. His temperature was 101.1 degrees F (Fahrenheit), heart rate was 102/minute, BP (blood pressure) was 112/66. A laboratory evaluation revealed Cr (creatinine) of 1.8mg/dL, BUN (blood urea nitrogen) of 50mg/dL, Hgb (hemoglobin) of 12.1 g/dl, hematocrit of 35.6%, platelet count of 35,000/uL, LDH (lactate dehydrogenase) of 590U/L and haptoglobin of <10mg/dL. C3 and C4 complement levels were both low at 58mg/dL and 12 mg/dL respectively. Schistocytes were seen on a peripheral smear. Urinalysis showed trace proteinuria and <1rbc/hpf (red blood cells per high power field). Plasma ADAMTS13 activity was normal and stools were negative for Shiga toxin-producing Escherichia coli. Despite therapeutic plasma exchange (TPE) for seven days, hemolysis continued, thrombocytopenia worsened and the patient developed multi-organ failure. Hemodialysis (HD) was initiated for uremia and volume overload on hospital stay day 10. The patient was commenced on eculizumab given that he had TPE-resistant Atypical Hemolytic Uremic Syndrome (aHUS). TPE was no longer performed. By four doses of eculizumab, his platelets normalised, LDH improved and he came off HD. His creatinine was stabilised at 1.1 mg/dl. Respiratory failure and hepatic injury also resolved. Genetic analysis did not demonstrate any factor H gene mutation in the patient. Outcome was unknown.
Age: 76.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Body temperature increased, Complement factor C3, Complement factor C4 decreased, Complement factor normal, Confusional state
Clinical narrative: This medically confirmed literature case (initial receipt 20-May-2014) concerns a 76 year old male patient. On an unspecified date, the patient received a influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date after the flu vaccine, the patient presented with a one week history of generalised weakness and an unsteady gait. He had two episodes of non-bloody diarrhoea and decreased urine output. On physical examination, the patient was confused, lethargic and had dry mucous membranes. His temperature was 101.1 degrees F (Fahrenheit), heart rate was 102/minute, BP (blood pressure) was 112/66. A laboratory evaluation revealed Cr (creatinine) of 1.8mg/dL, BUN (blood urea nitrogen) of 50mg/dL, Hgb (hemoglobin) of 12.1 g/dl, hematocrit of 35.6%, platelet count of 35,000/uL, LDH (lactate dehydrogenase) of 590U/L and haptoglobin of <10mg/dL. C3 and C4 complement levels were both low at 58mg/dL and 12 mg/dL respectively. Schistocytes were seen on a peripheral smear. Urinalysis showed trace proteinuria and <1rbc/hpf (red blood cells per high power field). Plasma ADAMTS13 activity was normal and stools were negative for Shiga toxin-producing Escherichia coli. Despite therapeutic plasma exchange (TPE) for seven days, hemolysis continued, thrombocytopenia worsened and the patient developed multi-organ failure. Hemodialysis (HD) was initiated for uremia and volume overload on hospital stay day 10. The patient was commenced on eculizumab given that he had TPE-resistant Atypical Hemolytic Uremic Syndrome (aHUS). TPE was no longer performed. By four doses of eculizumab, his platelets normalised, LDH improved and he came off HD. His creatinine was stabilised at 1.1 mg/dl. Respiratory failure and hepatic injury also resolved. Genetic analysis did not demonstrate any factor H gene mutation in the patient. Outcome was unknown.
Age: 76.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Cytogenetic analysis normal, Diarrhoea, Escherichia test negative, Fluid overload, Gait disturbance
Clinical narrative: This medically confirmed literature case (initial receipt 20-May-2014) concerns a 76 year old male patient. On an unspecified date, the patient received a influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date after the flu vaccine, the patient presented with a one week history of generalised weakness and an unsteady gait. He had two episodes of non-bloody diarrhoea and decreased urine output. On physical examination, the patient was confused, lethargic and had dry mucous membranes. His temperature was 101.1 degrees F (Fahrenheit), heart rate was 102/minute, BP (blood pressure) was 112/66. A laboratory evaluation revealed Cr (creatinine) of 1.8mg/dL, BUN (blood urea nitrogen) of 50mg/dL, Hgb (hemoglobin) of 12.1 g/dl, hematocrit of 35.6%, platelet count of 35,000/uL, LDH (lactate dehydrogenase) of 590U/L and haptoglobin of <10mg/dL. C3 and C4 complement levels were both low at 58mg/dL and 12 mg/dL respectively. Schistocytes were seen on a peripheral smear. Urinalysis showed trace proteinuria and <1rbc/hpf (red blood cells per high power field). Plasma ADAMTS13 activity was normal and stools were negative for Shiga toxin-producing Escherichia coli. Despite therapeutic plasma exchange (TPE) for seven days, hemolysis continued, thrombocytopenia worsened and the patient developed multi-organ failure. Hemodialysis (HD) was initiated for uremia and volume overload on hospital stay day 10. The patient was commenced on eculizumab given that he had TPE-resistant Atypical Hemolytic Uremic Syndrome (aHUS). TPE was no longer performed. By four doses of eculizumab, his platelets normalised, LDH improved and he came off HD. His creatinine was stabilised at 1.1 mg/dl. Respiratory failure and hepatic injury also resolved. Genetic analysis did not demonstrate any factor H gene mutation in the patient. Outcome was unknown.
Age: 76.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Haematocrit decreased, Haemodialysis, Haemoglobin decreased, Haemolysis, Haemolytic uraemic syndrome
Clinical narrative: This medically confirmed literature case (initial receipt 20-May-2014) concerns a 76 year old male patient. On an unspecified date, the patient received a influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date after the flu vaccine, the patient presented with a one week history of generalised weakness and an unsteady gait. He had two episodes of non-bloody diarrhoea and decreased urine output. On physical examination, the patient was confused, lethargic and had dry mucous membranes. His temperature was 101.1 degrees F (Fahrenheit), heart rate was 102/minute, BP (blood pressure) was 112/66. A laboratory evaluation revealed Cr (creatinine) of 1.8mg/dL, BUN (blood urea nitrogen) of 50mg/dL, Hgb (hemoglobin) of 12.1 g/dl, hematocrit of 35.6%, platelet count of 35,000/uL, LDH (lactate dehydrogenase) of 590U/L and haptoglobin of <10mg/dL. C3 and C4 complement levels were both low at 58mg/dL and 12 mg/dL respectively. Schistocytes were seen on a peripheral smear. Urinalysis showed trace proteinuria and <1rbc/hpf (red blood cells per high power field). Plasma ADAMTS13 activity was normal and stools were negative for Shiga toxin-producing Escherichia coli. Despite therapeutic plasma exchange (TPE) for seven days, hemolysis continued, thrombocytopenia worsened and the patient developed multi-organ failure. Hemodialysis (HD) was initiated for uremia and volume overload on hospital stay day 10. The patient was commenced on eculizumab given that he had TPE-resistant Atypical Hemolytic Uremic Syndrome (aHUS). TPE was no longer performed. By four doses of eculizumab, his platelets normalised, LDH improved and he came off HD. His creatinine was stabilised at 1.1 mg/dl. Respiratory failure and hepatic injury also resolved. Genetic analysis did not demonstrate any factor H gene mutation in the patient. Outcome was unknown.
Age: 76.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Haptoglobin, Lethargy, Liver injury, Mucosal dryness, Multi-organ failure
Clinical narrative: This medically confirmed literature case (initial receipt 20-May-2014) concerns a 76 year old male patient. On an unspecified date, the patient received a influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date after the flu vaccine, the patient presented with a one week history of generalised weakness and an unsteady gait. He had two episodes of non-bloody diarrhoea and decreased urine output. On physical examination, the patient was confused, lethargic and had dry mucous membranes. His temperature was 101.1 degrees F (Fahrenheit), heart rate was 102/minute, BP (blood pressure) was 112/66. A laboratory evaluation revealed Cr (creatinine) of 1.8mg/dL, BUN (blood urea nitrogen) of 50mg/dL, Hgb (hemoglobin) of 12.1 g/dl, hematocrit of 35.6%, platelet count of 35,000/uL, LDH (lactate dehydrogenase) of 590U/L and haptoglobin of <10mg/dL. C3 and C4 complement levels were both low at 58mg/dL and 12 mg/dL respectively. Schistocytes were seen on a peripheral smear. Urinalysis showed trace proteinuria and <1rbc/hpf (red blood cells per high power field). Plasma ADAMTS13 activity was normal and stools were negative for Shiga toxin-producing Escherichia coli. Despite therapeutic plasma exchange (TPE) for seven days, hemolysis continued, thrombocytopenia worsened and the patient developed multi-organ failure. Hemodialysis (HD) was initiated for uremia and volume overload on hospital stay day 10. The patient was commenced on eculizumab given that he had TPE-resistant Atypical Hemolytic Uremic Syndrome (aHUS). TPE was no longer performed. By four doses of eculizumab, his platelets normalised, LDH improved and he came off HD. His creatinine was stabilised at 1.1 mg/dl. Respiratory failure and hepatic injury also resolved. Genetic analysis did not demonstrate any factor H gene mutation in the patient. Outcome was unknown.
Age: 76.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Plasmapheresis, Platelet count decreased, Protein urine present, Proteinuria, Red blood cell schistocytes present
Clinical narrative: This medically confirmed literature case (initial receipt 20-May-2014) concerns a 76 year old male patient. On an unspecified date, the patient received a influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date after the flu vaccine, the patient presented with a one week history of generalised weakness and an unsteady gait. He had two episodes of non-bloody diarrhoea and decreased urine output. On physical examination, the patient was confused, lethargic and had dry mucous membranes. His temperature was 101.1 degrees F (Fahrenheit), heart rate was 102/minute, BP (blood pressure) was 112/66. A laboratory evaluation revealed Cr (creatinine) of 1.8mg/dL, BUN (blood urea nitrogen) of 50mg/dL, Hgb (hemoglobin) of 12.1 g/dl, hematocrit of 35.6%, platelet count of 35,000/uL, LDH (lactate dehydrogenase) of 590U/L and haptoglobin of <10mg/dL. C3 and C4 complement levels were both low at 58mg/dL and 12 mg/dL respectively. Schistocytes were seen on a peripheral smear. Urinalysis showed trace proteinuria and <1rbc/hpf (red blood cells per high power field). Plasma ADAMTS13 activity was normal and stools were negative for Shiga toxin-producing Escherichia coli. Despite therapeutic plasma exchange (TPE) for seven days, hemolysis continued, thrombocytopenia worsened and the patient developed multi-organ failure. Hemodialysis (HD) was initiated for uremia and volume overload on hospital stay day 10. The patient was commenced on eculizumab given that he had TPE-resistant Atypical Hemolytic Uremic Syndrome (aHUS). TPE was no longer performed. By four doses of eculizumab, his platelets normalised, LDH improved and he came off HD. His creatinine was stabilised at 1.1 mg/dl. Respiratory failure and hepatic injury also resolved. Genetic analysis did not demonstrate any factor H gene mutation in the patient. Outcome was unknown.
Age: 76.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Respiratory failure, Thrombocytopenia, Urine output decreased
Clinical narrative: This medically confirmed literature case (initial receipt 20-May-2014) concerns a 76 year old male patient. On an unspecified date, the patient received a influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date after the flu vaccine, the patient presented with a one week history of generalised weakness and an unsteady gait. He had two episodes of non-bloody diarrhoea and decreased urine output. On physical examination, the patient was confused, lethargic and had dry mucous membranes. His temperature was 101.1 degrees F (Fahrenheit), heart rate was 102/minute, BP (blood pressure) was 112/66. A laboratory evaluation revealed Cr (creatinine) of 1.8mg/dL, BUN (blood urea nitrogen) of 50mg/dL, Hgb (hemoglobin) of 12.1 g/dl, hematocrit of 35.6%, platelet count of 35,000/uL, LDH (lactate dehydrogenase) of 590U/L and haptoglobin of <10mg/dL. C3 and C4 complement levels were both low at 58mg/dL and 12 mg/dL respectively. Schistocytes were seen on a peripheral smear. Urinalysis showed trace proteinuria and <1rbc/hpf (red blood cells per high power field). Plasma ADAMTS13 activity was normal and stools were negative for Shiga toxin-producing Escherichia coli. Despite therapeutic plasma exchange (TPE) for seven days, hemolysis continued, thrombocytopenia worsened and the patient developed multi-organ failure. Hemodialysis (HD) was initiated for uremia and volume overload on hospital stay day 10. The patient was commenced on eculizumab given that he had TPE-resistant Atypical Hemolytic Uremic Syndrome (aHUS). TPE was no longer performed. By four doses of eculizumab, his platelets normalised, LDH improved and he came off HD. His creatinine was stabilised at 1.1 mg/dl. Respiratory failure and hepatic injury also resolved. Genetic analysis did not demonstrate any factor H gene mutation in the patient. Outcome was unknown.
Age: 76.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Complement factor C3, Complement factor C4 decreased, Complement factor normal, Confusional state, Cytogenetic analysis normal
Clinical narrative: This medically confirmed literature case (initial receipt 20-May-2014) concerns a 76 year old male patient. On an unspecified date, the patient received a influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date after the flu vaccine, the patient presented with a one week history of generalised weakness and an unsteady gait. He had two episodes of non-bloody diarrhoea and decreased urine output. On physical examination, the patient was confused, lethargic and had dry mucous membranes. His temperature was 101.1 degrees F (Fahrenheit), heart rate was 102/minute, BP (blood pressure) was 112/66. A laboratory evaluation revealed Cr (creatinine) of 1.8mg/dL, BUN (blood urea nitrogen) of 50mg/dL, Hgb (hemoglobin) of 12.1 g/dl, hematocrit of 35.6%, platelet count of 35,000/uL, LDH (lactate dehydrogenase) of 590U/L and haptoglobin of <10mg/dL. C3 and C4 complement levels were both low at 58mg/dL and 12 mg/dL respectively. Schistocytes were seen on a peripheral smear. Urinalysis showed trace proteinuria and <1rbc/hpf (red blood cells per high power field). Plasma ADAMTS13 activity was normal and stools were negative for Shiga toxin-producing Escherichia coli. Despite therapeutic plasma exchange (TPE) for seven days, hemolysis continued, thrombocytopenia worsened and the patient developed multi-organ failure. Hemodialysis (HD) was initiated for uremia and volume overload on hospital stay day 10. The patient was commenced on eculizumab given that he had TPE-resistant Atypical Hemolytic Uremic Syndrome (aHUS). TPE was no longer performed. By four doses of eculizumab, his platelets normalised, LDH improved and he came off HD. His creatinine was stabilised at 1.1 mg/dl. Respiratory failure and hepatic injury also resolved. Genetic analysis did not demonstrate any factor H gene mutation in the patient. Outcome was unknown.
Age: 76.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Diarrhoea, Escherichia test negative, Fluid overload, Gait disturbance, Haematocrit decreased
Clinical narrative: This medically confirmed literature case (initial receipt 20-May-2014) concerns a 76 year old male patient. On an unspecified date, the patient received a influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date after the flu vaccine, the patient presented with a one week history of generalised weakness and an unsteady gait. He had two episodes of non-bloody diarrhoea and decreased urine output. On physical examination, the patient was confused, lethargic and had dry mucous membranes. His temperature was 101.1 degrees F (Fahrenheit), heart rate was 102/minute, BP (blood pressure) was 112/66. A laboratory evaluation revealed Cr (creatinine) of 1.8mg/dL, BUN (blood urea nitrogen) of 50mg/dL, Hgb (hemoglobin) of 12.1 g/dl, hematocrit of 35.6%, platelet count of 35,000/uL, LDH (lactate dehydrogenase) of 590U/L and haptoglobin of <10mg/dL. C3 and C4 complement levels were both low at 58mg/dL and 12 mg/dL respectively. Schistocytes were seen on a peripheral smear. Urinalysis showed trace proteinuria and <1rbc/hpf (red blood cells per high power field). Plasma ADAMTS13 activity was normal and stools were negative for Shiga toxin-producing Escherichia coli. Despite therapeutic plasma exchange (TPE) for seven days, hemolysis continued, thrombocytopenia worsened and the patient developed multi-organ failure. Hemodialysis (HD) was initiated for uremia and volume overload on hospital stay day 10. The patient was commenced on eculizumab given that he had TPE-resistant Atypical Hemolytic Uremic Syndrome (aHUS). TPE was no longer performed. By four doses of eculizumab, his platelets normalised, LDH improved and he came off HD. His creatinine was stabilised at 1.1 mg/dl. Respiratory failure and hepatic injury also resolved. Genetic analysis did not demonstrate any factor H gene mutation in the patient. Outcome was unknown.
Age: 76.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Haemodialysis, Haemoglobin decreased, Haemolysis, Haemolytic uraemic syndrome, Haptoglobin decreased
Clinical narrative: This medically confirmed literature case (initial receipt 20-May-2014) concerns a 76 year old male patient. On an unspecified date, the patient received a influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date after the flu vaccine, the patient presented with a one week history of generalised weakness and an unsteady gait. He had two episodes of non-bloody diarrhoea and decreased urine output. On physical examination, the patient was confused, lethargic and had dry mucous membranes. His temperature was 101.1 degrees F (Fahrenheit), heart rate was 102/minute, BP (blood pressure) was 112/66. A laboratory evaluation revealed Cr (creatinine) of 1.8mg/dL, BUN (blood urea nitrogen) of 50mg/dL, Hgb (hemoglobin) of 12.1 g/dl, hematocrit of 35.6%, platelet count of 35,000/uL, LDH (lactate dehydrogenase) of 590U/L and haptoglobin of <10mg/dL. C3 and C4 complement levels were both low at 58mg/dL and 12 mg/dL respectively. Schistocytes were seen on a peripheral smear. Urinalysis showed trace proteinuria and <1rbc/hpf (red blood cells per high power field). Plasma ADAMTS13 activity was normal and stools were negative for Shiga toxin-producing Escherichia coli. Despite therapeutic plasma exchange (TPE) for seven days, hemolysis continued, thrombocytopenia worsened and the patient developed multi-organ failure. Hemodialysis (HD) was initiated for uremia and volume overload on hospital stay day 10. The patient was commenced on eculizumab given that he had TPE-resistant Atypical Hemolytic Uremic Syndrome (aHUS). TPE was no longer performed. By four doses of eculizumab, his platelets normalised, LDH improved and he came off HD. His creatinine was stabilised at 1.1 mg/dl. Respiratory failure and hepatic injury also resolved. Genetic analysis did not demonstrate any factor H gene mutation in the patient. Outcome was unknown.
Age: 76.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Lethargy, Liver injury, Mucosal dryness, Multi-organ failure, Plasmapheresis
Clinical narrative: This medically confirmed literature case (initial receipt 20-May-2014) concerns a 76 year old male patient. On an unspecified date, the patient received a influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date after the flu vaccine, the patient presented with a one week history of generalised weakness and an unsteady gait. He had two episodes of non-bloody diarrhoea and decreased urine output. On physical examination, the patient was confused, lethargic and had dry mucous membranes. His temperature was 101.1 degrees F (Fahrenheit), heart rate was 102/minute, BP (blood pressure) was 112/66. A laboratory evaluation revealed Cr (creatinine) of 1.8mg/dL, BUN (blood urea nitrogen) of 50mg/dL, Hgb (hemoglobin) of 12.1 g/dl, hematocrit of 35.6%, platelet count of 35,000/uL, LDH (lactate dehydrogenase) of 590U/L and haptoglobin of <10mg/dL. C3 and C4 complement levels were both low at 58mg/dL and 12 mg/dL respectively. Schistocytes were seen on a peripheral smear. Urinalysis showed trace proteinuria and <1rbc/hpf (red blood cells per high power field). Plasma ADAMTS13 activity was normal and stools were negative for Shiga toxin-producing Escherichia coli. Despite therapeutic plasma exchange (TPE) for seven days, hemolysis continued, thrombocytopenia worsened and the patient developed multi-organ failure. Hemodialysis (HD) was initiated for uremia and volume overload on hospital stay day 10. The patient was commenced on eculizumab given that he had TPE-resistant Atypical Hemolytic Uremic Syndrome (aHUS). TPE was no longer performed. By four doses of eculizumab, his platelets normalised, LDH improved and he came off HD. His creatinine was stabilised at 1.1 mg/dl. Respiratory failure and hepatic injury also resolved. Genetic analysis did not demonstrate any factor H gene mutation in the patient. Outcome was unknown.
Age: 76.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Platelet count decreased, Protein total normal, Protein urine present, Proteinuria, Red blood cell schistocytes present
Clinical narrative: This medically confirmed literature case (initial receipt 20-May-2014) concerns a 76 year old male patient. On an unspecified date, the patient received a influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date after the flu vaccine, the patient presented with a one week history of generalised weakness and an unsteady gait. He had two episodes of non-bloody diarrhoea and decreased urine output. On physical examination, the patient was confused, lethargic and had dry mucous membranes. His temperature was 101.1 degrees F (Fahrenheit), heart rate was 102/minute, BP (blood pressure) was 112/66. A laboratory evaluation revealed Cr (creatinine) of 1.8mg/dL, BUN (blood urea nitrogen) of 50mg/dL, Hgb (hemoglobin) of 12.1 g/dl, hematocrit of 35.6%, platelet count of 35,000/uL, LDH (lactate dehydrogenase) of 590U/L and haptoglobin of <10mg/dL. C3 and C4 complement levels were both low at 58mg/dL and 12 mg/dL respectively. Schistocytes were seen on a peripheral smear. Urinalysis showed trace proteinuria and <1rbc/hpf (red blood cells per high power field). Plasma ADAMTS13 activity was normal and stools were negative for Shiga toxin-producing Escherichia coli. Despite therapeutic plasma exchange (TPE) for seven days, hemolysis continued, thrombocytopenia worsened and the patient developed multi-organ failure. Hemodialysis (HD) was initiated for uremia and volume overload on hospital stay day 10. The patient was commenced on eculizumab given that he had TPE-resistant Atypical Hemolytic Uremic Syndrome (aHUS). TPE was no longer performed. By four doses of eculizumab, his platelets normalised, LDH improved and he came off HD. His creatinine was stabilised at 1.1 mg/dl. Respiratory failure and hepatic injury also resolved. Genetic analysis did not demonstrate any factor H gene mutation in the patient. Outcome was unknown.
Age: 76.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Red blood cells urine positive, Respiratory failure, Stool analysis normal, Thrombocytopenia, Urine output decreased
Clinical narrative: This medically confirmed literature case (initial receipt 20-May-2014) concerns a 76 year old male patient. On an unspecified date, the patient received a influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date after the flu vaccine, the patient presented with a one week history of generalised weakness and an unsteady gait. He had two episodes of non-bloody diarrhoea and decreased urine output. On physical examination, the patient was confused, lethargic and had dry mucous membranes. His temperature was 101.1 degrees F (Fahrenheit), heart rate was 102/minute, BP (blood pressure) was 112/66. A laboratory evaluation revealed Cr (creatinine) of 1.8mg/dL, BUN (blood urea nitrogen) of 50mg/dL, Hgb (hemoglobin) of 12.1 g/dl, hematocrit of 35.6%, platelet count of 35,000/uL, LDH (lactate dehydrogenase) of 590U/L and haptoglobin of <10mg/dL. C3 and C4 complement levels were both low at 58mg/dL and 12 mg/dL respectively. Schistocytes were seen on a peripheral smear. Urinalysis showed trace proteinuria and <1rbc/hpf (red blood cells per high power field). Plasma ADAMTS13 activity was normal and stools were negative for Shiga toxin-producing Escherichia coli. Despite therapeutic plasma exchange (TPE) for seven days, hemolysis continued, thrombocytopenia worsened and the patient developed multi-organ failure. Hemodialysis (HD) was initiated for uremia and volume overload on hospital stay day 10. The patient was commenced on eculizumab given that he had TPE-resistant Atypical Hemolytic Uremic Syndrome (aHUS). TPE was no longer performed. By four doses of eculizumab, his platelets normalised, LDH improved and he came off HD. His creatinine was stabilised at 1.1 mg/dl. Respiratory failure and hepatic injury also resolved. Genetic analysis did not demonstrate any factor H gene mutation in the patient. Outcome was unknown.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route of administration, LOT# and expiration date were not reported). Other suspect therapy included a dose of influenza virus vaccine (manufacturer unknown) (dose, route of administration, LOT# and expiration date were not reported), administered on an unspecified date. The patient was found unconscious (date unspecified) and rushed to emergency room (on an unspecified date, after receiving PNEUMOVAX 23). The patient was admitted in an unspecified hospital (on an unknown date) for an unspecified length of time. The outcome of the event was not reported. The relatedness among the event and PNEUMOVAX 23 and influenza virus vaccine (manufacturer unknown) was not reported. Upon internal review the event "patient was found unconscious" was considered to be medically significant. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Anaemia, Leukaemia, Pyrexia
Clinical narrative: This spontaneous report as received from a nurse practitioner via a field representative refers to a 3 year old male patient. The patient's medical history and current condition was not reported. On 06-MAY-2014 the patient was vaccinated with M-M-R II, single shot (lot number and expiry date unknown) via subcutaneous route (product lot number and expiry date was not reported). No concomitant medications were not reported. On 21-MAY-2014 the patient experienced high fever and became anemic and was referred to a hematologist. On 21-MAY-2014 the patient was diagnosed with leukemia and was currently in the hospital. The outcome of the events was reported as not recovered. A product quality complaint was not involved. The action taken with the therapy with M-M-R II was unknown. The relatedness of the events to the therapy with M-M-R II was unknown. Upon internal review, the event leukemia was considered to be medically significant and other seriousness criteria include hospitalization. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Acute lymphocytic leukaemia, Asthenia, Basophil percentage decreased, Decreased appetite, Differential white blood cell count
Clinical narrative: This spontaneous report as received from a nurse practitioner via a field representative refers to a 3 year old male patient. The patient's medical history and current condition was not reported. On 06-MAY-2014 the patient was vaccinated with M-M-R II, single shot (lot number and expiry date unknown) via subcutaneous route (product lot number and expiry date was not reported). No concomitant medications were not reported. On 21-MAY-2014 the patient experienced high fever and became anemic and was referred to a hematologist. On 21-MAY-2014 the patient was diagnosed with leukemia and was currently in the hospital. The outcome of the events was reported as not recovered. A product quality complaint was not involved. The action taken with the therapy with M-M-R II was unknown. The relatedness of the events to the therapy with M-M-R II was unknown. Upon internal review, the event leukemia was considered to be medically significant and other seriousness criteria include hospitalization. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Eosinophil percentage decreased, Full blood count, Granulocyte percentage, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: This spontaneous report as received from a nurse practitioner via a field representative refers to a 3 year old male patient. The patient's medical history and current condition was not reported. On 06-MAY-2014 the patient was vaccinated with M-M-R II, single shot (lot number and expiry date unknown) via subcutaneous route (product lot number and expiry date was not reported). No concomitant medications were not reported. On 21-MAY-2014 the patient experienced high fever and became anemic and was referred to a hematologist. On 21-MAY-2014 the patient was diagnosed with leukemia and was currently in the hospital. The outcome of the events was reported as not recovered. A product quality complaint was not involved. The action taken with the therapy with M-M-R II was unknown. The relatedness of the events to the therapy with M-M-R II was unknown. Upon internal review, the event leukemia was considered to be medically significant and other seriousness criteria include hospitalization. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Lymphocyte percentage increased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Monocyte percentage
Clinical narrative: This spontaneous report as received from a nurse practitioner via a field representative refers to a 3 year old male patient. The patient's medical history and current condition was not reported. On 06-MAY-2014 the patient was vaccinated with M-M-R II, single shot (lot number and expiry date unknown) via subcutaneous route (product lot number and expiry date was not reported). No concomitant medications were not reported. On 21-MAY-2014 the patient experienced high fever and became anemic and was referred to a hematologist. On 21-MAY-2014 the patient was diagnosed with leukemia and was currently in the hospital. The outcome of the events was reported as not recovered. A product quality complaint was not involved. The action taken with the therapy with M-M-R II was unknown. The relatedness of the events to the therapy with M-M-R II was unknown. Upon internal review, the event leukemia was considered to be medically significant and other seriousness criteria include hospitalization. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Neutrophil count decreased, Pain, Pain in extremity, Pallor, Platelet count decreased
Clinical narrative: This spontaneous report as received from a nurse practitioner via a field representative refers to a 3 year old male patient. The patient's medical history and current condition was not reported. On 06-MAY-2014 the patient was vaccinated with M-M-R II, single shot (lot number and expiry date unknown) via subcutaneous route (product lot number and expiry date was not reported). No concomitant medications were not reported. On 21-MAY-2014 the patient experienced high fever and became anemic and was referred to a hematologist. On 21-MAY-2014 the patient was diagnosed with leukemia and was currently in the hospital. The outcome of the events was reported as not recovered. A product quality complaint was not involved. The action taken with the therapy with M-M-R II was unknown. The relatedness of the events to the therapy with M-M-R II was unknown. Upon internal review, the event leukemia was considered to be medically significant and other seriousness criteria include hospitalization. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Pyrexia, Red blood cell count decreased, Serum ferritin increased, Toe walking, White blood cell count normal
Clinical narrative: This spontaneous report as received from a nurse practitioner via a field representative refers to a 3 year old male patient. The patient's medical history and current condition was not reported. On 06-MAY-2014 the patient was vaccinated with M-M-R II, single shot (lot number and expiry date unknown) via subcutaneous route (product lot number and expiry date was not reported). No concomitant medications were not reported. On 21-MAY-2014 the patient experienced high fever and became anemic and was referred to a hematologist. On 21-MAY-2014 the patient was diagnosed with leukemia and was currently in the hospital. The outcome of the events was reported as not recovered. A product quality complaint was not involved. The action taken with the therapy with M-M-R II was unknown. The relatedness of the events to the therapy with M-M-R II was unknown. Upon internal review, the event leukemia was considered to be medically significant and other seriousness criteria include hospitalization. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: HEPAB
Symptoms: Eye pain, Eye swelling
Clinical narrative: Patient stated woke up next day and had right eye pain and swelling.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Joint swelling, Laboratory test, Mixed connective tissue disease, Systemic lupus erythematosus
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 13 years old female patient. In 2013 the patient was vaccinated with GARDASIL third dose (dose on schedule) lot # not provided. On an unspecified date in February 2014 patient presented to the physician's office with knee swelling. On unknown date in 2014 the patient had unspecified testing (unspecified date) and was diagnosed with lupus. Reporting person stated that the patient then had further unspecified testing and was determined to have "mixed connective tissue disease". The outcome of lupus and mixed connective tissue disease was reported as not recovered. Relatedness between events and vaccination with GARDASIL was not reported. Upon internal review the lupus was considered to be medically significant. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Eye movement disorder, Febrile convulsion, Laboratory test, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Febrile seizure while awaiting airline travel.  Became stiff and eyes rolled back.  Transported to ER.  Fever to 103. Episode lasted 15 minutes with 30-60 minutes post-ictal somnolence.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Somnolence
Clinical narrative: Febrile seizure while awaiting airline travel.  Became stiff and eyes rolled back.  Transported to ER.  Fever to 103. Episode lasted 15 minutes with 30-60 minutes post-ictal somnolence.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Axillary pain, Bite, Blister, Erythema, Herpes zoster
Clinical narrative: Five swollen "bites" across left shoulder and one on chest, left side.  These became more swollen and then blistered and weeped within the next 24 hours. Very itchydeveloped two red spots on each. By third day sharp pains deep in arm pit and on surface.  These were relieved by pressure for short time.  today is 06/03/2014 and pain continues but not so frequent. Bites are hard lumps, still red and swollen, but milder. I believe that I was bitten by stink bugs as they were present in the room in the morning and that these bites provoked a case of shingles..which I have never had previously.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Induration, Pruritus, Rash erythematous, Swelling, Wound secretion
Clinical narrative: Five swollen "bites" across left shoulder and one on chest, left side.  These became more swollen and then blistered and weeped within the next 24 hours. Very itchydeveloped two red spots on each. By third day sharp pains deep in arm pit and on surface.  These were relieved by pressure for short time.  today is 06/03/2014 and pain continues but not so frequent. Bites are hard lumps, still red and swollen, but milder. I believe that I was bitten by stink bugs as they were present in the room in the morning and that these bites provoked a case of shingles..which I have never had previously.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness and warm on site of injection.  Aprox 3 inch size  Got little indurated and with cold compress got much better.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Nausea, headache, stomach ache, fever, tiredness.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Swelling and redness of upper left arm from shoulder to elbow, itching.