chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.3
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL, MMR, VARCEL
Symptoms: Diarrhoea, Encephalopathy, Endotracheal intubation, Enterovirus test negative, Enzyme level test
Clinical narrative: This spontaneous report as received from a physician refers to a 15 month old female patient, who on 10-JUL-2013, was vaccinated with VARIVAX (Merck) (dose, route and lot number were not reported). Other suspect therapies included M-M-R II (dose, route and lot number were not reported) and HepA (manufacturer unknown) (date, dose, route and lot number were not reported). The physician reported about a month after vaccinations were given in August 2013, the patient developed disseminated varicella disease, hemolytic anemia, rubella, mumps, and developmental regression of the brain. The patient sought medical attention, the patient's parents brought infant to the hospital. The patient was hospitalized at an unspecified hospital A in early September and was transferred to Hospital B on 05-SEP-2013 and had been there ever since that date. The patient has had her spinal fluid looked at, her varicella like rash biopsied and it tested positive for varicella, and has received daily blood transfusions. Patient also has received oxygen, CPAP, and has been intubated. Patient was also on IGB, steroids, acyclovir, and foscarnet. The physician was sending out VZVIP packet since this AE involved developmental regression of the brain affecting areas of the Pons in the patient's brain detected by a MRI. At the time of the report, the patient had not recovered from the adverse events. The relatedness for the adverse events were unknown for VARIVAX (Merck), HepA (manufacturer unknown) and M-M-R II. The events of regression of the brain affecting areas of the pons, mumps, hemolytic anemia, rubella and disseminated varicella disease and tracheal intubation were considered disability and life threatening by the physician. The events were considered to be an other important medical events by the physician. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL, MMR, VARCEL
Symptoms: Epstein-Barr virus test negative, Free fatty acids, Fungal test, Fungal test negative, General physical health deterioration
Clinical narrative: This spontaneous report as received from a physician refers to a 15 month old female patient, who on 10-JUL-2013, was vaccinated with VARIVAX (Merck) (dose, route and lot number were not reported). Other suspect therapies included M-M-R II (dose, route and lot number were not reported) and HepA (manufacturer unknown) (date, dose, route and lot number were not reported). The physician reported about a month after vaccinations were given in August 2013, the patient developed disseminated varicella disease, hemolytic anemia, rubella, mumps, and developmental regression of the brain. The patient sought medical attention, the patient's parents brought infant to the hospital. The patient was hospitalized at an unspecified hospital A in early September and was transferred to Hospital B on 05-SEP-2013 and had been there ever since that date. The patient has had her spinal fluid looked at, her varicella like rash biopsied and it tested positive for varicella, and has received daily blood transfusions. Patient also has received oxygen, CPAP, and has been intubated. Patient was also on IGB, steroids, acyclovir, and foscarnet. The physician was sending out VZVIP packet since this AE involved developmental regression of the brain affecting areas of the Pons in the patient's brain detected by a MRI. At the time of the report, the patient had not recovered from the adverse events. The relatedness for the adverse events were unknown for VARIVAX (Merck), HepA (manufacturer unknown) and M-M-R II. The events of regression of the brain affecting areas of the pons, mumps, hemolytic anemia, rubella and disseminated varicella disease and tracheal intubation were considered disability and life threatening by the physician. The events were considered to be an other important medical events by the physician. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL, MMR, VARCEL
Symptoms: Gram stain positive, HIV test negative, Herpes simplex serology negative, Herpes virus infection, Human herpes virus 6 serology negative
Clinical narrative: This spontaneous report as received from a physician refers to a 15 month old female patient, who on 10-JUL-2013, was vaccinated with VARIVAX (Merck) (dose, route and lot number were not reported). Other suspect therapies included M-M-R II (dose, route and lot number were not reported) and HepA (manufacturer unknown) (date, dose, route and lot number were not reported). The physician reported about a month after vaccinations were given in August 2013, the patient developed disseminated varicella disease, hemolytic anemia, rubella, mumps, and developmental regression of the brain. The patient sought medical attention, the patient's parents brought infant to the hospital. The patient was hospitalized at an unspecified hospital A in early September and was transferred to Hospital B on 05-SEP-2013 and had been there ever since that date. The patient has had her spinal fluid looked at, her varicella like rash biopsied and it tested positive for varicella, and has received daily blood transfusions. Patient also has received oxygen, CPAP, and has been intubated. Patient was also on IGB, steroids, acyclovir, and foscarnet. The physician was sending out VZVIP packet since this AE involved developmental regression of the brain affecting areas of the Pons in the patient's brain detected by a MRI. At the time of the report, the patient had not recovered from the adverse events. The relatedness for the adverse events were unknown for VARIVAX (Merck), HepA (manufacturer unknown) and M-M-R II. The events of regression of the brain affecting areas of the pons, mumps, hemolytic anemia, rubella and disseminated varicella disease and tracheal intubation were considered disability and life threatening by the physician. The events were considered to be an other important medical events by the physician. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL, MMR, VARCEL
Symptoms: Human rhinovirus test positive, Immunoglobulin therapy, Influenza B virus test, Influenza virus test negative, Intensive care
Clinical narrative: This spontaneous report as received from a physician refers to a 15 month old female patient, who on 10-JUL-2013, was vaccinated with VARIVAX (Merck) (dose, route and lot number were not reported). Other suspect therapies included M-M-R II (dose, route and lot number were not reported) and HepA (manufacturer unknown) (date, dose, route and lot number were not reported). The physician reported about a month after vaccinations were given in August 2013, the patient developed disseminated varicella disease, hemolytic anemia, rubella, mumps, and developmental regression of the brain. The patient sought medical attention, the patient's parents brought infant to the hospital. The patient was hospitalized at an unspecified hospital A in early September and was transferred to Hospital B on 05-SEP-2013 and had been there ever since that date. The patient has had her spinal fluid looked at, her varicella like rash biopsied and it tested positive for varicella, and has received daily blood transfusions. Patient also has received oxygen, CPAP, and has been intubated. Patient was also on IGB, steroids, acyclovir, and foscarnet. The physician was sending out VZVIP packet since this AE involved developmental regression of the brain affecting areas of the Pons in the patient's brain detected by a MRI. At the time of the report, the patient had not recovered from the adverse events. The relatedness for the adverse events were unknown for VARIVAX (Merck), HepA (manufacturer unknown) and M-M-R II. The events of regression of the brain affecting areas of the pons, mumps, hemolytic anemia, rubella and disseminated varicella disease and tracheal intubation were considered disability and life threatening by the physician. The events were considered to be an other important medical events by the physician. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL, MMR, VARCEL
Symptoms: Jaundice, Klebsiella infection, Klebsiella test positive, Legionella test, Lipids
Clinical narrative: This spontaneous report as received from a physician refers to a 15 month old female patient, who on 10-JUL-2013, was vaccinated with VARIVAX (Merck) (dose, route and lot number were not reported). Other suspect therapies included M-M-R II (dose, route and lot number were not reported) and HepA (manufacturer unknown) (date, dose, route and lot number were not reported). The physician reported about a month after vaccinations were given in August 2013, the patient developed disseminated varicella disease, hemolytic anemia, rubella, mumps, and developmental regression of the brain. The patient sought medical attention, the patient's parents brought infant to the hospital. The patient was hospitalized at an unspecified hospital A in early September and was transferred to Hospital B on 05-SEP-2013 and had been there ever since that date. The patient has had her spinal fluid looked at, her varicella like rash biopsied and it tested positive for varicella, and has received daily blood transfusions. Patient also has received oxygen, CPAP, and has been intubated. Patient was also on IGB, steroids, acyclovir, and foscarnet. The physician was sending out VZVIP packet since this AE involved developmental regression of the brain affecting areas of the Pons in the patient's brain detected by a MRI. At the time of the report, the patient had not recovered from the adverse events. The relatedness for the adverse events were unknown for VARIVAX (Merck), HepA (manufacturer unknown) and M-M-R II. The events of regression of the brain affecting areas of the pons, mumps, hemolytic anemia, rubella and disseminated varicella disease and tracheal intubation were considered disability and life threatening by the physician. The events were considered to be an other important medical events by the physician. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL, MMR, VARCEL
Symptoms: Lumbar puncture abnormal, Lymphocyte stimulation test, Measles antibody negative, Mumps antibody test, Muscular weakness
Clinical narrative: This spontaneous report as received from a physician refers to a 15 month old female patient, who on 10-JUL-2013, was vaccinated with VARIVAX (Merck) (dose, route and lot number were not reported). Other suspect therapies included M-M-R II (dose, route and lot number were not reported) and HepA (manufacturer unknown) (date, dose, route and lot number were not reported). The physician reported about a month after vaccinations were given in August 2013, the patient developed disseminated varicella disease, hemolytic anemia, rubella, mumps, and developmental regression of the brain. The patient sought medical attention, the patient's parents brought infant to the hospital. The patient was hospitalized at an unspecified hospital A in early September and was transferred to Hospital B on 05-SEP-2013 and had been there ever since that date. The patient has had her spinal fluid looked at, her varicella like rash biopsied and it tested positive for varicella, and has received daily blood transfusions. Patient also has received oxygen, CPAP, and has been intubated. Patient was also on IGB, steroids, acyclovir, and foscarnet. The physician was sending out VZVIP packet since this AE involved developmental regression of the brain affecting areas of the Pons in the patient's brain detected by a MRI. At the time of the report, the patient had not recovered from the adverse events. The relatedness for the adverse events were unknown for VARIVAX (Merck), HepA (manufacturer unknown) and M-M-R II. The events of regression of the brain affecting areas of the pons, mumps, hemolytic anemia, rubella and disseminated varicella disease and tracheal intubation were considered disability and life threatening by the physician. The events were considered to be an other important medical events by the physician. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL, MMR, VARCEL
Symptoms: Mycoplasma test, Natural killer cell count, Nervous system disorder, Neurological decompensation, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: This spontaneous report as received from a physician refers to a 15 month old female patient, who on 10-JUL-2013, was vaccinated with VARIVAX (Merck) (dose, route and lot number were not reported). Other suspect therapies included M-M-R II (dose, route and lot number were not reported) and HepA (manufacturer unknown) (date, dose, route and lot number were not reported). The physician reported about a month after vaccinations were given in August 2013, the patient developed disseminated varicella disease, hemolytic anemia, rubella, mumps, and developmental regression of the brain. The patient sought medical attention, the patient's parents brought infant to the hospital. The patient was hospitalized at an unspecified hospital A in early September and was transferred to Hospital B on 05-SEP-2013 and had been there ever since that date. The patient has had her spinal fluid looked at, her varicella like rash biopsied and it tested positive for varicella, and has received daily blood transfusions. Patient also has received oxygen, CPAP, and has been intubated. Patient was also on IGB, steroids, acyclovir, and foscarnet. The physician was sending out VZVIP packet since this AE involved developmental regression of the brain affecting areas of the Pons in the patient's brain detected by a MRI. At the time of the report, the patient had not recovered from the adverse events. The relatedness for the adverse events were unknown for VARIVAX (Merck), HepA (manufacturer unknown) and M-M-R II. The events of regression of the brain affecting areas of the pons, mumps, hemolytic anemia, rubella and disseminated varicella disease and tracheal intubation were considered disability and life threatening by the physician. The events were considered to be an other important medical events by the physician. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL, MMR, VARCEL
Symptoms: Nuclear magnetic resonance imaging spinal abnormal, Organic acid analysis, Parasite stool test negative, Polymerase chain reaction, Pseudomonas infection
Clinical narrative: This spontaneous report as received from a physician refers to a 15 month old female patient, who on 10-JUL-2013, was vaccinated with VARIVAX (Merck) (dose, route and lot number were not reported). Other suspect therapies included M-M-R II (dose, route and lot number were not reported) and HepA (manufacturer unknown) (date, dose, route and lot number were not reported). The physician reported about a month after vaccinations were given in August 2013, the patient developed disseminated varicella disease, hemolytic anemia, rubella, mumps, and developmental regression of the brain. The patient sought medical attention, the patient's parents brought infant to the hospital. The patient was hospitalized at an unspecified hospital A in early September and was transferred to Hospital B on 05-SEP-2013 and had been there ever since that date. The patient has had her spinal fluid looked at, her varicella like rash biopsied and it tested positive for varicella, and has received daily blood transfusions. Patient also has received oxygen, CPAP, and has been intubated. Patient was also on IGB, steroids, acyclovir, and foscarnet. The physician was sending out VZVIP packet since this AE involved developmental regression of the brain affecting areas of the Pons in the patient's brain detected by a MRI. At the time of the report, the patient had not recovered from the adverse events. The relatedness for the adverse events were unknown for VARIVAX (Merck), HepA (manufacturer unknown) and M-M-R II. The events of regression of the brain affecting areas of the pons, mumps, hemolytic anemia, rubella and disseminated varicella disease and tracheal intubation were considered disability and life threatening by the physician. The events were considered to be an other important medical events by the physician. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL, MMR, VARCEL
Symptoms: Rash papular, Rhinovirus infection, Rubella antibody test, Scab, Serum ferritin increased
Clinical narrative: This spontaneous report as received from a physician refers to a 15 month old female patient, who on 10-JUL-2013, was vaccinated with VARIVAX (Merck) (dose, route and lot number were not reported). Other suspect therapies included M-M-R II (dose, route and lot number were not reported) and HepA (manufacturer unknown) (date, dose, route and lot number were not reported). The physician reported about a month after vaccinations were given in August 2013, the patient developed disseminated varicella disease, hemolytic anemia, rubella, mumps, and developmental regression of the brain. The patient sought medical attention, the patient's parents brought infant to the hospital. The patient was hospitalized at an unspecified hospital A in early September and was transferred to Hospital B on 05-SEP-2013 and had been there ever since that date. The patient has had her spinal fluid looked at, her varicella like rash biopsied and it tested positive for varicella, and has received daily blood transfusions. Patient also has received oxygen, CPAP, and has been intubated. Patient was also on IGB, steroids, acyclovir, and foscarnet. The physician was sending out VZVIP packet since this AE involved developmental regression of the brain affecting areas of the Pons in the patient's brain detected by a MRI. At the time of the report, the patient had not recovered from the adverse events. The relatedness for the adverse events were unknown for VARIVAX (Merck), HepA (manufacturer unknown) and M-M-R II. The events of regression of the brain affecting areas of the pons, mumps, hemolytic anemia, rubella and disseminated varicella disease and tracheal intubation were considered disability and life threatening by the physician. The events were considered to be an other important medical events by the physician. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL, MMR, VARCEL
Symptoms: Stool analysis normal, T-lymphocyte count decreased, Thyroxine decreased, Transfusion, Tuberculin test negative
Clinical narrative: This spontaneous report as received from a physician refers to a 15 month old female patient, who on 10-JUL-2013, was vaccinated with VARIVAX (Merck) (dose, route and lot number were not reported). Other suspect therapies included M-M-R II (dose, route and lot number were not reported) and HepA (manufacturer unknown) (date, dose, route and lot number were not reported). The physician reported about a month after vaccinations were given in August 2013, the patient developed disseminated varicella disease, hemolytic anemia, rubella, mumps, and developmental regression of the brain. The patient sought medical attention, the patient's parents brought infant to the hospital. The patient was hospitalized at an unspecified hospital A in early September and was transferred to Hospital B on 05-SEP-2013 and had been there ever since that date. The patient has had her spinal fluid looked at, her varicella like rash biopsied and it tested positive for varicella, and has received daily blood transfusions. Patient also has received oxygen, CPAP, and has been intubated. Patient was also on IGB, steroids, acyclovir, and foscarnet. The physician was sending out VZVIP packet since this AE involved developmental regression of the brain affecting areas of the Pons in the patient's brain detected by a MRI. At the time of the report, the patient had not recovered from the adverse events. The relatedness for the adverse events were unknown for VARIVAX (Merck), HepA (manufacturer unknown) and M-M-R II. The events of regression of the brain affecting areas of the pons, mumps, hemolytic anemia, rubella and disseminated varicella disease and tracheal intubation were considered disability and life threatening by the physician. The events were considered to be an other important medical events by the physician. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL, MMR, VARCEL
Symptoms: Urine analysis normal, Varicella virus test positive, Viral test negative, Vitamin B12, Warm type haemolytic anaemia
Clinical narrative: This spontaneous report as received from a physician refers to a 15 month old female patient, who on 10-JUL-2013, was vaccinated with VARIVAX (Merck) (dose, route and lot number were not reported). Other suspect therapies included M-M-R II (dose, route and lot number were not reported) and HepA (manufacturer unknown) (date, dose, route and lot number were not reported). The physician reported about a month after vaccinations were given in August 2013, the patient developed disseminated varicella disease, hemolytic anemia, rubella, mumps, and developmental regression of the brain. The patient sought medical attention, the patient's parents brought infant to the hospital. The patient was hospitalized at an unspecified hospital A in early September and was transferred to Hospital B on 05-SEP-2013 and had been there ever since that date. The patient has had her spinal fluid looked at, her varicella like rash biopsied and it tested positive for varicella, and has received daily blood transfusions. Patient also has received oxygen, CPAP, and has been intubated. Patient was also on IGB, steroids, acyclovir, and foscarnet. The physician was sending out VZVIP packet since this AE involved developmental regression of the brain affecting areas of the Pons in the patient's brain detected by a MRI. At the time of the report, the patient had not recovered from the adverse events. The relatedness for the adverse events were unknown for VARIVAX (Merck), HepA (manufacturer unknown) and M-M-R II. The events of regression of the brain affecting areas of the pons, mumps, hemolytic anemia, rubella and disseminated varicella disease and tracheal intubation were considered disability and life threatening by the physician. The events were considered to be an other important medical events by the physician. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL, MMR, VARCEL
Symptoms: White matter lesion
Clinical narrative: This spontaneous report as received from a physician refers to a 15 month old female patient, who on 10-JUL-2013, was vaccinated with VARIVAX (Merck) (dose, route and lot number were not reported). Other suspect therapies included M-M-R II (dose, route and lot number were not reported) and HepA (manufacturer unknown) (date, dose, route and lot number were not reported). The physician reported about a month after vaccinations were given in August 2013, the patient developed disseminated varicella disease, hemolytic anemia, rubella, mumps, and developmental regression of the brain. The patient sought medical attention, the patient's parents brought infant to the hospital. The patient was hospitalized at an unspecified hospital A in early September and was transferred to Hospital B on 05-SEP-2013 and had been there ever since that date. The patient has had her spinal fluid looked at, her varicella like rash biopsied and it tested positive for varicella, and has received daily blood transfusions. Patient also has received oxygen, CPAP, and has been intubated. Patient was also on IGB, steroids, acyclovir, and foscarnet. The physician was sending out VZVIP packet since this AE involved developmental regression of the brain affecting areas of the Pons in the patient's brain detected by a MRI. At the time of the report, the patient had not recovered from the adverse events. The relatedness for the adverse events were unknown for VARIVAX (Merck), HepA (manufacturer unknown) and M-M-R II. The events of regression of the brain affecting areas of the pons, mumps, hemolytic anemia, rubella and disseminated varicella disease and tracheal intubation were considered disability and life threatening by the physician. The events were considered to be an other important medical events by the physician. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL, MMR, VARCEL
Symptoms: Biopsy skin abnormal, CSF culture positive, CSF test abnormal, Continuous positive airway pressure, Endotracheal intubation
Clinical narrative: This spontaneous report as received from a physician refers to a 15 month old female patient, who on 10-JUL-2013, was vaccinated with VARIVAX (Merck) (dose, route and lot number were not reported). Other suspect therapies included M-M-R II (dose, route and lot number were not reported) and HepA (manufacturer unknown) (date, dose, route and lot number were not reported). The physician reported about a month after vaccinations were given in August 2013, the patient developed disseminated varicella disease, hemolytic anemia, rubella, mumps, and developmental regression of the brain. The patient sought medical attention, the patient's parents brought infant to the hospital. The patient was hospitalized at an unspecified hospital A in early September and was transferred to Hospital B on 05-SEP-2013 and had been there ever since that date. The patient has had her spinal fluid looked at, her varicella like rash biopsied and it tested positive for varicella, and has received daily blood transfusions. Patient also has received oxygen, CPAP, and has been intubated. Patient was also on IGB, steroids, acyclovir, and foscarnet. The physician was sending out VZVIP packet since this AE involved developmental regression of the brain affecting areas of the Pons in the patient's brain detected by a MRI. At the time of the report, the patient had not recovered from the adverse events. The relatedness for the adverse events were unknown for VARIVAX (Merck), HepA (manufacturer unknown) and M-M-R II. The events of regression of the brain affecting areas of the pons, mumps, hemolytic anemia, rubella and disseminated varicella disease and tracheal intubation were considered disability and life threatening by the physician. The events were considered to be an other important medical events by the physician. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL, MMR, VARCEL
Symptoms: Haemolytic anaemia, Mumps, Nervous system disorder, Nuclear magnetic resonance imaging brain abnormal, Rubella
Clinical narrative: This spontaneous report as received from a physician refers to a 15 month old female patient, who on 10-JUL-2013, was vaccinated with VARIVAX (Merck) (dose, route and lot number were not reported). Other suspect therapies included M-M-R II (dose, route and lot number were not reported) and HepA (manufacturer unknown) (date, dose, route and lot number were not reported). The physician reported about a month after vaccinations were given in August 2013, the patient developed disseminated varicella disease, hemolytic anemia, rubella, mumps, and developmental regression of the brain. The patient sought medical attention, the patient's parents brought infant to the hospital. The patient was hospitalized at an unspecified hospital A in early September and was transferred to Hospital B on 05-SEP-2013 and had been there ever since that date. The patient has had her spinal fluid looked at, her varicella like rash biopsied and it tested positive for varicella, and has received daily blood transfusions. Patient also has received oxygen, CPAP, and has been intubated. Patient was also on IGB, steroids, acyclovir, and foscarnet. The physician was sending out VZVIP packet since this AE involved developmental regression of the brain affecting areas of the Pons in the patient's brain detected by a MRI. At the time of the report, the patient had not recovered from the adverse events. The relatedness for the adverse events were unknown for VARIVAX (Merck), HepA (manufacturer unknown) and M-M-R II. The events of regression of the brain affecting areas of the pons, mumps, hemolytic anemia, rubella and disseminated varicella disease and tracheal intubation were considered disability and life threatening by the physician. The events were considered to be an other important medical events by the physician. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL, MMR, VARCEL
Symptoms: Transfusion, Varicella post vaccine, Varicella virus test positive
Clinical narrative: This spontaneous report as received from a physician refers to a 15 month old female patient, who on 10-JUL-2013, was vaccinated with VARIVAX (Merck) (dose, route and lot number were not reported). Other suspect therapies included M-M-R II (dose, route and lot number were not reported) and HepA (manufacturer unknown) (date, dose, route and lot number were not reported). The physician reported about a month after vaccinations were given in August 2013, the patient developed disseminated varicella disease, hemolytic anemia, rubella, mumps, and developmental regression of the brain. The patient sought medical attention, the patient's parents brought infant to the hospital. The patient was hospitalized at an unspecified hospital A in early September and was transferred to Hospital B on 05-SEP-2013 and had been there ever since that date. The patient has had her spinal fluid looked at, her varicella like rash biopsied and it tested positive for varicella, and has received daily blood transfusions. Patient also has received oxygen, CPAP, and has been intubated. Patient was also on IGB, steroids, acyclovir, and foscarnet. The physician was sending out VZVIP packet since this AE involved developmental regression of the brain affecting areas of the Pons in the patient's brain detected by a MRI. At the time of the report, the patient had not recovered from the adverse events. The relatedness for the adverse events were unknown for VARIVAX (Merck), HepA (manufacturer unknown) and M-M-R II. The events of regression of the brain affecting areas of the pons, mumps, hemolytic anemia, rubella and disseminated varicella disease and tracheal intubation were considered disability and life threatening by the physician. The events were considered to be an other important medical events by the physician. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Injection site pain, Rash macular, Skin warm
Clinical narrative: Developed hot, red swollen area left arm around injection site measuring 7.5" x 3" (inches).
Age: 54.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Developed hot, red swollen area left arm around injection site measuring 7.5" x 3" (inches).
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Cardiac hypertrophy, Chest pain, Dyspnoea, Pericardial effusion, Tachypnoea
Clinical narrative: Dspnea, tachypnea, chest pain.
Age: 0.76
Sex: F
Vaccine: HEP
Symptoms: Irritability, Pyrexia, Rash, Vomiting
Clinical narrative: Fever, vomiting, extreme fussiness, rash.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Accidental exposure to product, Eye irritation, Eye pain
Clinical narrative: This case was reported by a pharmacy student and described the occurrence of sore eye in a 23-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 24 September 2012 at 16:20 the subject received unspecified dose of BOOSTRIX (unknown). On 24 September 2012, at the time of vaccination with BOOSTRIX, the subject experienced eyes splashed with vaccine. On 24 September 2012, within minutes of vaccination with BOOSTRIX, the subject experienced sore eye and eye irritation. The pharmacy student, who is also the subject, reported there was pressure in the bottle of BOOSTRIX and thinks it sprayed from the bottle into her right eye. The reporter did not consider there to be anything wrong with the BOOSTRIX vial. The subject's right eye was a bit sore and irritated however she said it could be from rinsing it. The reported planned to seek medical attention. At the time of reporting the sore eye and eye irritation were unresolved.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling abnormal, Injection site discolouration, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of pain during injection in a 39-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). There were no concurrent medications. On 16 September 2011 the subject received 1st dose of BOOSTRIX (.5 ml, unknown, right deltoid). On 16 September 2011, during vaccination with BOOSTRIX, the subject experienced pain during injection. The next day (17 September 2011), she experienced pain at the injection site, swelling at the injection site. About one day later (on or about 18 September 2011), she noticed a dark spot at the injection site which is unresolved at time of report. The subject felt a lump or bump at injection site. This is also unresolved. She noted her arm is just not the same [feeling different]. The subject noted that this particular injection was more painful than any vaccine injection she received [pain during injection]. The subject reported the events began one day after the actual injection. At the time of reporting the pain during injection, swelling injection site, injection site lump, injection site pruritus, injection site discoloration and arm is just not he same [feeling different] were unresolved. The healthcare professional considered the events were possibly related to vaccination with BOOSTRIX.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of pain during injection in a 39-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). There were no concurrent medications. On 16 September 2011 the subject received 1st dose of BOOSTRIX (.5 ml, unknown, right deltoid). On 16 September 2011, during vaccination with BOOSTRIX, the subject experienced pain during injection. The next day (17 September 2011), she experienced pain at the injection site, swelling at the injection site. About one day later (on or about 18 September 2011), she noticed a dark spot at the injection site which is unresolved at time of report. The subject felt a lump or bump at injection site. This is also unresolved. She noted her arm is just not the same [feeling different]. The subject noted that this particular injection was more painful than any vaccine injection she received [pain during injection]. The subject reported the events began one day after the actual injection. At the time of reporting the pain during injection, swelling injection site, injection site lump, injection site pruritus, injection site discoloration and arm is just not he same [feeling different] were unresolved. The healthcare professional considered the events were possibly related to vaccination with BOOSTRIX.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Rash maculo-papular
Clinical narrative: Maculopapular rash to chest area was given benadryl by parent 30 min before receiving vaccine.
Age: 1.41
Sex: M
Vaccine: DTAP, FLU3, HIBV, MMR
Symptoms: Measles, Pyrexia, Rash macular
Clinical narrative: Fever and macular rash consistent with measles.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Convulsion, Febrile convulsion, Pyrexia
Clinical narrative: Pt had a temp of 102F on 9/27/12 at 8PM. At 2AM on 9/28 Pt had a febrile seizure that last 10 minutes. He fell back to sleep and woke up at 6AM and had a seizure that lasted 5 minutes went to ER.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site urticaria, Injection site vesicles, Malaise, Pain
Clinical narrative: 10-1-13 Pt. rec'd Quadrivalent FLUZONE Vaccine. Immediately c/o itching. 5 min. later - sm. blisters (hives) formed next to injection site. BENADRYL 50 adm. into other deltoid. Itching subsided. Pt. returned home and medicated self with BENADRYL again. No further itching. 10-2-13, general malaise and body aches - relieved with ADVIL.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: 10-1-13 Pt. rec'd Quadrivalent FLUZONE Vaccine. Immediately c/o itching. 5 min. later - sm. blisters (hives) formed next to injection site. BENADRYL 50 adm. into other deltoid. Itching subsided. Pt. returned home and medicated self with BENADRYL again. No further itching. 10-2-13, general malaise and body aches - relieved with ADVIL.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Guest developed pain in left arm after being administered a FLUZONE HD injection. Her arm is fine when not moving but use is limited due to the pain. It at times bother her to where she has trouble sleeping.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Warmth and red swelling at site developing over 2 days. Pt hs hx of other allergies. TX was Benadryl PO and topical. Pt has Epi Pen available if needed. Pt records updated to poss. allergic rxn to Neomycin or Poly mix.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass, Pain in extremity
Clinical narrative: Pt state 4 wk post inj arm still sore and lump where shot administered.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Erythema, Headache, Musculoskeletal stiffness, Pain
Clinical narrative: PT states, redness, swelling, warm to touch, achy, headache, stiffness in shoulders, dizziness. This started on Wednesday, patient came to see me on Friday. Advised to see her provider.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm, Swelling
Clinical narrative: PT states, redness, swelling, warm to touch, achy, headache, stiffness in shoulders, dizziness. This started on Wednesday, patient came to see me on Friday. Advised to see her provider.
Age: 64.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site discolouration, Pain in extremity
Clinical narrative: There is still (as of today 10/3/2013) slight yellow / blue discoloration around the area of the injection and the arm still hurts.
Age: 28.0
Sex: M
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Lymph node pain, Pain in extremity
Clinical narrative: Severe pain in entire right arm. Unable to move shoulder, elbow, wrist, hand. Bi-lateral axillary lymph nodes tender.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Reported local reaction following influenza vaccination on 09/26/2013. Left deltoid injection site swollen, red, tender, warm and itchy; symptoms began 09/26/2013 following the injection; site measures about 3" in diameter. She treated with Benadryl 25mg po at HS last night with no relief. Diphenhydramine cream applied. Administered Ibuprofen 400mg po. Advised to continue with OTC Diphenhydramine cream if helpful. Recommended regular Ibuprofen therapy, Benadryl po at HS and ice therapy. Provided ice bag. Advised to monitor for increased size and severity of local reaction and if symptoms worsen or do not improve to seek medical care, i.e. Urgent Care.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Local reaction
Clinical narrative: Reported local reaction following influenza vaccination on 09/26/2013. Left deltoid injection site swollen, red, tender, warm and itchy; symptoms began 09/26/2013 following the injection; site measures about 3" in diameter. She treated with Benadryl 25mg po at HS last night with no relief. Diphenhydramine cream applied. Administered Ibuprofen 400mg po. Advised to continue with OTC Diphenhydramine cream if helpful. Recommended regular Ibuprofen therapy, Benadryl po at HS and ice therapy. Provided ice bag. Advised to monitor for increased size and severity of local reaction and if symptoms worsen or do not improve to seek medical care, i.e. Urgent Care.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Asthenia, Blood urine present, Body temperature increased, Chest X-ray normal
Clinical narrative: Was feeling like she was having an "out of body experience" and went home, the following day (Tues) had chills, HA, body aches/pains, nausea and ST, Weds felt sl better in am but that evening felt hot and sweaty, THurs still had chills, temp, felt hot and cold, pain in all joints, HA, weak, did not had thermometer so didn't have temp recorded; now developed itchy hive rash (lasted for 1.5 days); temp 100.2 on 9/23/13.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Chills, Feeling abnormal, Feeling cold, Feeling hot, Headache
Clinical narrative: Was feeling like she was having an "out of body experience" and went home, the following day (Tues) had chills, HA, body aches/pains, nausea and ST, Weds felt sl better in am but that evening felt hot and sweaty, THurs still had chills, temp, felt hot and cold, pain in all joints, HA, weak, did not had thermometer so didn't have temp recorded; now developed itchy hive rash (lasted for 1.5 days); temp 100.2 on 9/23/13.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Hyperhidrosis, Laboratory test normal, Nausea, Pain, Rash pruritic
Clinical narrative: Was feeling like she was having an "out of body experience" and went home, the following day (Tues) had chills, HA, body aches/pains, nausea and ST, Weds felt sl better in am but that evening felt hot and sweaty, THurs still had chills, temp, felt hot and cold, pain in all joints, HA, weak, did not had thermometer so didn't have temp recorded; now developed itchy hive rash (lasted for 1.5 days); temp 100.2 on 9/23/13.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Urticaria, White blood cell count decreased
Clinical narrative: Was feeling like she was having an "out of body experience" and went home, the following day (Tues) had chills, HA, body aches/pains, nausea and ST, Weds felt sl better in am but that evening felt hot and sweaty, THurs still had chills, temp, felt hot and cold, pain in all joints, HA, weak, did not had thermometer so didn't have temp recorded; now developed itchy hive rash (lasted for 1.5 days); temp 100.2 on 9/23/13.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a male patient of unknown age. It was reported that the patient who had been on an unspecified immunosuppressive medication was vaccinated with a dose of ZOSTAVAX (lot number, expiry date and route was not reported). It was also reported that the patient did not disclose his full list of medications to the physician and that existing medication was not fully co-ordinated with the administration of ZOSTAVAX. Two days after administration of ZOSTAVAX, the patient experienced shingles rash. The patient was immediately admitted to the hospital where he was treated with unspecified drip for an unspecified duration and was reported to have improved. The outcome of shingles rash was reported as recovering at the time of this report. The patient sought medical attention (physician appointment). Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Body temperature increased, Erythema, Feeling cold, Local swelling, Myalgia
Clinical narrative: Whole arm swollen, red splotching over entire arm, full-body myalgias, fever, chills, all of which lasted for > 4 days (still present).
Age: 33.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Pyrexia, Rash macular
Clinical narrative: Whole arm swollen, red splotching over entire arm, full-body myalgias, fever, chills, all of which lasted for > 4 days (still present).
Age: 33.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Local swelling, Malaise, Myalgia, Pain, Pain in extremity
Clinical narrative: Whole arm swollen, red splotching over entire arm, full-body myalgias, fever, chills, all of which lasted for > 4 days (still present).
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hive chest and abdomen.  Employee took 25 mg Benadryl po which resolved symptoms.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Dysgeusia, Erythema, Pruritus, Swelling face
Clinical narrative: Metallic taste, face swelling, redness and itching.  Chest tightness.
Sex: M
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: High fever and they kept him an additional night for observation.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Blood test, Computerised tomogram head, Dizziness, Nuclear magnetic resonance imaging, Vertigo
Clinical narrative: Extreme vertigo, dizziness, spinning, vomiting - Rushed to the hospital in an ambulance and was in the hospital for 3 days.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Extreme vertigo, dizziness, spinning, vomiting - Rushed to the hospital in an ambulance and was in the hospital for 3 days.
Age: 37.0
Sex: M
Vaccine: FLUN4, YF
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: Member was given a multidose vial of yellow fever. 0.5 ML was drawn from a 3 ML vial and reconstituted into a 5 dose vial. That solution was then drawn out and given to the patient.  Pt waited in clinic for 2 1/2 hrs in clinic with no immediate reactions. Provider and CDC were notified and questioned for appropriate steps and actions. Pt was given the Vaccine Nurse Line through the CDC and instructed to contact them if any side effects occur. Pt will be contacted today for further follow up.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Fall, Injection site exfoliation, Injection site pain, Injection site pruritus
Clinical narrative: Woke up with extreme dizziness the morning following injection.  Caused me to fall in my bathroom.  At injection site on left arm, a scaly, itchy, and burning rash appeared about the size of a dollar bill.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash
Clinical narrative: Woke up with extreme dizziness the morning following injection.  Caused me to fall in my bathroom.  At injection site on left arm, a scaly, itchy, and burning rash appeared about the size of a dollar bill.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Myalgia
Clinical narrative: Extreme chills with chattering teeth. Muscle aches. Lasted 6 hours.
Age: 27.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Redness (75 mm), itching pain @ site- warm to touch.
Age: 27.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Redness, (75mm), itching pain at site - warm to touch.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Nausea, Pain in extremity, Vomiting
Clinical narrative: Upon awakening: 5:15AM-soreness in R arm, nausea, vomiting and headache which continue through 10:30AM (time of report). Ate usual bkft-inc. water/coffee and is now leaving work early.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Lip swelling, Lymphadenopathy, Pain, Pharyngeal oedema
Clinical narrative: Swelling of lips, tongue and throat. Additional symptoms: headache, low grade fever, body aches, swollen glands. Self-treated with Benadryl. Symptoms are still present but improving.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Swollen tongue
Clinical narrative: Swelling of lips, tongue and throat. Additional symptoms: headache, low grade fever, body aches, swollen glands. Self-treated with Benadryl. Symptoms are still present but improving.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Influenza shot. Left arm red and itchy at shot sight just below shoulder socket in muscle.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Headache, Pain, Swelling, Tenderness
Clinical narrative: Redness and tenderness initially, on 10/3/13 the area was swollen, red, painful and she had a significant headache. Was advised to use Tylenol 650mg q4h and apply alternating warm compresses and ice pack to the area.  To notify me if symptoms exacerbated.