chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLU3
Symptoms: Unresponsive to stimuli
Clinical narrative: This case was reported in a literature article and described the occurrence of hemorrhagic cerebral infarction in a 64-year-old male subject who was vaccinated with influenza virus vaccine (influenza vaccine, manufacturer unspecified). Concurrent medical conditions included atrial fibrillation, chronic obstructive pulmonary disease, depression, diabetes mellitus (type2), gastroesophageal reflux, hypercholesterolemia and hypertension. Concurrent medications included Warfarin 5 mg every other day alternating with 2,5 mg, Celecoxib 200 mg as needed for pain, ipratropium/albuterol inhaler 2 puffs twice daily, diltiazem 120 mg twice daily, metformin 500 mg twice daily, hydrochlorothiazide/losartan 25 mg/100 mg daily, escitalopram 20 mg daily, lansoprazole 30 mg daily, propranolol 40 mg twice daily, and ezetimibe/simvastatin 10 mg/40 mg daily. All medication regimens were unchanged for at least 6 months. None of his medications was altered. The patient had been seen in the clinic 5 weeks prior to presentation. At the time, his INR was 2,0 and he received unspecified dose of Influenza vaccine (unknown route, unknown injection site). Lot number was not available. 5 weeks after vaccination with Influenza vaccine, the subject was hospitalized after becoming unresponsive at home. At the admission, the patient had been unresponsive for approximately 1 hour. The patient was experiencing rectal bleeding for the previous 2 days. The initial international normalized ratio (INR) was greater than 15; INR values over the previous 6 months were relatively stable. Relevant test were performed and showed the following results: Hemoglobin: 8,3 g/dL (normal range 14-18); Hematocrit: 24% (normal range 42-52); Platelet count: 412 x 10^3 /uL (normal range 150-430); low serum albumin: 3,1 g/dL (normal range 3,5-5,0); total bilirubin: 0,8 mg/dL (normal range 0,2-1,0); aspartate aminotransferase: 16 IU/L (normal range 10-42); alanine aminotransferase:12 IU/L (normal range 10-40); blood pressure: 166/60 mm Hg, heart rate: 62 beats/min; respiration rate:16 breaths/min; temperature was not documented. A non-contrast computed tomography scan of the head revealed a large parenchymal hemorrhagic infarction involving the left temporal, parietal, and occipital lobes. The radiologist noted a significant mass effect including 12mm rightward midline shift and impending uncal herniation. The subject was treated in the emergency department with Nitroglycerin infusion to maintain systolic blood pressure in the range of 140-160 mm Hg as well as the infusion of 4 units of fresh frozen plasma and 10 mg of vitamin K. Following a neurosurgery evaluation, it was determined that nothing meaningful could be done to alter the patient's outcome positively. Comfort measures were implemented and the patient died approximately 17 hours after admission. The author considered the events were possibly related to the interaction between Warfarin and vaccination with Influenza vaccine.
Age: 64.0
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLU3
Symptoms: Computerised tomogram abnormal, Computerised tomogram head, Death, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: This case was reported in a literature article and described the occurrence of hemorrhagic cerebral infarction in a 64-year-old male subject who was vaccinated with influenza virus vaccine (influenza vaccine, manufacturer unspecified). Concurrent medical conditions included atrial fibrillation, chronic obstructive pulmonary disease, depression, diabetes mellitus (type2), gastroesophageal reflux, hypercholesterolemia and hypertension. Concurrent medications included Warfarin 5 mg every other day alternating with 2,5 mg, Celecoxib 200 mg as needed for pain, ipratropium/albuterol inhaler 2 puffs twice daily, diltiazem 120 mg twice daily, metformin 500 mg twice daily, hydrochlorothiazide/losartan 25 mg/100 mg daily, escitalopram 20 mg daily, lansoprazole 30 mg daily, propranolol 40 mg twice daily, and ezetimibe/simvastatin 10 mg/40 mg daily. All medication regimens were unchanged for at least 6 months. None of his medications was altered. The patient had been seen in the clinic 5 weeks prior to presentation. At the time, his INR was 2,0 and he received unspecified dose of Influenza vaccine (unknown route, unknown injection site). Lot number was not available. 5 weeks after vaccination with Influenza vaccine, the subject was hospitalized after becoming unresponsive at home. At the admission, the patient had been unresponsive for approximately 1 hour. The patient was experiencing rectal bleeding for the previous 2 days. The initial international normalized ratio (INR) was greater than 15; INR values over the previous 6 months were relatively stable. Relevant test were performed and showed the following results: Hemoglobin: 8,3 g/dL (normal range 14-18); Hematocrit: 24% (normal range 42-52); Platelet count: 412 x 10^3 /uL (normal range 150-430); low serum albumin: 3,1 g/dL (normal range 3,5-5,0); total bilirubin: 0,8 mg/dL (normal range 0,2-1,0); aspartate aminotransferase: 16 IU/L (normal range 10-42); alanine aminotransferase:12 IU/L (normal range 10-40); blood pressure: 166/60 mm Hg, heart rate: 62 beats/min; respiration rate:16 breaths/min; temperature was not documented. A non-contrast computed tomography scan of the head revealed a large parenchymal hemorrhagic infarction involving the left temporal, parietal, and occipital lobes. The radiologist noted a significant mass effect including 12mm rightward midline shift and impending uncal herniation. The subject was treated in the emergency department with Nitroglycerin infusion to maintain systolic blood pressure in the range of 140-160 mm Hg as well as the infusion of 4 units of fresh frozen plasma and 10 mg of vitamin K. Following a neurosurgery evaluation, it was determined that nothing meaningful could be done to alter the patient's outcome positively. Comfort measures were implemented and the patient died approximately 17 hours after admission. The author considered the events were possibly related to the interaction between Warfarin and vaccination with Influenza vaccine.
Age: 64.0
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLU3
Symptoms: Haemorrhagic cerebral infarction, Heart rate normal, International normalised ratio increased, Platelet count normal, Rectal haemorrhage
Clinical narrative: This case was reported in a literature article and described the occurrence of hemorrhagic cerebral infarction in a 64-year-old male subject who was vaccinated with influenza virus vaccine (influenza vaccine, manufacturer unspecified). Concurrent medical conditions included atrial fibrillation, chronic obstructive pulmonary disease, depression, diabetes mellitus (type2), gastroesophageal reflux, hypercholesterolemia and hypertension. Concurrent medications included Warfarin 5 mg every other day alternating with 2,5 mg, Celecoxib 200 mg as needed for pain, ipratropium/albuterol inhaler 2 puffs twice daily, diltiazem 120 mg twice daily, metformin 500 mg twice daily, hydrochlorothiazide/losartan 25 mg/100 mg daily, escitalopram 20 mg daily, lansoprazole 30 mg daily, propranolol 40 mg twice daily, and ezetimibe/simvastatin 10 mg/40 mg daily. All medication regimens were unchanged for at least 6 months. None of his medications was altered. The patient had been seen in the clinic 5 weeks prior to presentation. At the time, his INR was 2,0 and he received unspecified dose of Influenza vaccine (unknown route, unknown injection site). Lot number was not available. 5 weeks after vaccination with Influenza vaccine, the subject was hospitalized after becoming unresponsive at home. At the admission, the patient had been unresponsive for approximately 1 hour. The patient was experiencing rectal bleeding for the previous 2 days. The initial international normalized ratio (INR) was greater than 15; INR values over the previous 6 months were relatively stable. Relevant test were performed and showed the following results: Hemoglobin: 8,3 g/dL (normal range 14-18); Hematocrit: 24% (normal range 42-52); Platelet count: 412 x 10^3 /uL (normal range 150-430); low serum albumin: 3,1 g/dL (normal range 3,5-5,0); total bilirubin: 0,8 mg/dL (normal range 0,2-1,0); aspartate aminotransferase: 16 IU/L (normal range 10-42); alanine aminotransferase:12 IU/L (normal range 10-40); blood pressure: 166/60 mm Hg, heart rate: 62 beats/min; respiration rate:16 breaths/min; temperature was not documented. A non-contrast computed tomography scan of the head revealed a large parenchymal hemorrhagic infarction involving the left temporal, parietal, and occipital lobes. The radiologist noted a significant mass effect including 12mm rightward midline shift and impending uncal herniation. The subject was treated in the emergency department with Nitroglycerin infusion to maintain systolic blood pressure in the range of 140-160 mm Hg as well as the infusion of 4 units of fresh frozen plasma and 10 mg of vitamin K. Following a neurosurgery evaluation, it was determined that nothing meaningful could be done to alter the patient's outcome positively. Comfort measures were implemented and the patient died approximately 17 hours after admission. The author considered the events were possibly related to the interaction between Warfarin and vaccination with Influenza vaccine.
Age: 64.0
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLU3
Symptoms: Respiratory rate, Unresponsive to stimuli
Clinical narrative: This case was reported in a literature article and described the occurrence of hemorrhagic cerebral infarction in a 64-year-old male subject who was vaccinated with influenza virus vaccine (influenza vaccine, manufacturer unspecified). Concurrent medical conditions included atrial fibrillation, chronic obstructive pulmonary disease, depression, diabetes mellitus (type2), gastroesophageal reflux, hypercholesterolemia and hypertension. Concurrent medications included Warfarin 5 mg every other day alternating with 2,5 mg, Celecoxib 200 mg as needed for pain, ipratropium/albuterol inhaler 2 puffs twice daily, diltiazem 120 mg twice daily, metformin 500 mg twice daily, hydrochlorothiazide/losartan 25 mg/100 mg daily, escitalopram 20 mg daily, lansoprazole 30 mg daily, propranolol 40 mg twice daily, and ezetimibe/simvastatin 10 mg/40 mg daily. All medication regimens were unchanged for at least 6 months. None of his medications was altered. The patient had been seen in the clinic 5 weeks prior to presentation. At the time, his INR was 2,0 and he received unspecified dose of Influenza vaccine (unknown route, unknown injection site). Lot number was not available. 5 weeks after vaccination with Influenza vaccine, the subject was hospitalized after becoming unresponsive at home. At the admission, the patient had been unresponsive for approximately 1 hour. The patient was experiencing rectal bleeding for the previous 2 days. The initial international normalized ratio (INR) was greater than 15; INR values over the previous 6 months were relatively stable. Relevant test were performed and showed the following results: Hemoglobin: 8,3 g/dL (normal range 14-18); Hematocrit: 24% (normal range 42-52); Platelet count: 412 x 10^3 /uL (normal range 150-430); low serum albumin: 3,1 g/dL (normal range 3,5-5,0); total bilirubin: 0,8 mg/dL (normal range 0,2-1,0); aspartate aminotransferase: 16 IU/L (normal range 10-42); alanine aminotransferase:12 IU/L (normal range 10-40); blood pressure: 166/60 mm Hg, heart rate: 62 beats/min; respiration rate:16 breaths/min; temperature was not documented. A non-contrast computed tomography scan of the head revealed a large parenchymal hemorrhagic infarction involving the left temporal, parietal, and occipital lobes. The radiologist noted a significant mass effect including 12mm rightward midline shift and impending uncal herniation. The subject was treated in the emergency department with Nitroglycerin infusion to maintain systolic blood pressure in the range of 140-160 mm Hg as well as the infusion of 4 units of fresh frozen plasma and 10 mg of vitamin K. Following a neurosurgery evaluation, it was determined that nothing meaningful could be done to alter the patient's outcome positively. Comfort measures were implemented and the patient died approximately 17 hours after admission. The author considered the events were possibly related to the interaction between Warfarin and vaccination with Influenza vaccine.
Age: 64.0
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLU3
Symptoms: Cerebral infarction, Computerised tomogram abnormal, Death, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: This case was reported in a literature article and described the occurrence of hemorrhagic cerebral infarction in a 64-year-old male subject who was vaccinated with influenza virus vaccine (influenza vaccine, manufacturer unspecified). Concurrent medical conditions included atrial fibrillation, chronic obstructive pulmonary disease, depression, diabetes mellitus (type2), gastroesophageal reflux, hypercholesterolemia and hypertension. Concurrent medications included Warfarin 5 mg every other day alternating with 2,5 mg, Celecoxib 200 mg as needed for pain, ipratropium/albuterol inhaler 2 puffs twice daily, diltiazem 120 mg twice daily, metformin 500 mg twice daily, hydrochlorothiazide/losartan 25 mg/100 mg daily, escitalopram 20 mg daily, lansoprazole 30 mg daily, propranolol 40 mg twice daily, and ezetimibe/simvastatin 10 mg/40 mg daily. All medication regimens were unchanged for at least 6 months. None of his medications was altered. The patient had been seen in the clinic 5 weeks prior to presentation. At the time, his INR was 2,0 and he received unspecified dose of Influenza vaccine (unknown route, unknown injection site). Lot number was not available. 5 weeks after vaccination with Influenza vaccine, the subject was hospitalized after becoming unresponsive at home. At the admission, the patient had been unresponsive for approximately 1 hour. The patient was experiencing rectal bleeding for the previous 2 days. The initial international normalized ratio (INR) was greater than 15; INR values over the previous 6 months were relatively stable. Relevant test were performed and showed the following results: Hemoglobin: 8,3 g/dL (normal range 14-18); Hematocrit: 24% (normal range 42-52); Platelet count: 412 x 10^3 /uL (normal range 150-430); low serum albumin: 3,1 g/dL (normal range 3,5-5,0); total bilirubin: 0,8 mg/dL (normal range 0,2-1,0); aspartate aminotransferase: 16 IU/L (normal range 10-42); alanine aminotransferase:12 IU/L (normal range 10-40); blood pressure: 166/60 mm Hg, heart rate: 62 beats/min; respiration rate:16 breaths/min; temperature was not documented. A non-contrast computed tomography scan of the head revealed a large parenchymal hemorrhagic infarction involving the left temporal, parietal, and occipital lobes. The radiologist noted a significant mass effect including 12mm rightward midline shift and impending uncal herniation. The subject was treated in the emergency department with Nitroglycerin infusion to maintain systolic blood pressure in the range of 140-160 mm Hg as well as the infusion of 4 units of fresh frozen plasma and 10 mg of vitamin K. Following a neurosurgery evaluation, it was determined that nothing meaningful could be done to alter the patient's outcome positively. Comfort measures were implemented and the patient died approximately 17 hours after admission. The author considered the events were possibly related to the interaction between Warfarin and vaccination with Influenza vaccine.
Age: 64.0
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLU3
Symptoms: Haemorrhagic infarction, International normalised ratio increased, Platelet count normal, Rectal haemorrhage, Unresponsive to stimuli
Clinical narrative: This case was reported in a literature article and described the occurrence of hemorrhagic cerebral infarction in a 64-year-old male subject who was vaccinated with influenza virus vaccine (influenza vaccine, manufacturer unspecified). Concurrent medical conditions included atrial fibrillation, chronic obstructive pulmonary disease, depression, diabetes mellitus (type2), gastroesophageal reflux, hypercholesterolemia and hypertension. Concurrent medications included Warfarin 5 mg every other day alternating with 2,5 mg, Celecoxib 200 mg as needed for pain, ipratropium/albuterol inhaler 2 puffs twice daily, diltiazem 120 mg twice daily, metformin 500 mg twice daily, hydrochlorothiazide/losartan 25 mg/100 mg daily, escitalopram 20 mg daily, lansoprazole 30 mg daily, propranolol 40 mg twice daily, and ezetimibe/simvastatin 10 mg/40 mg daily. All medication regimens were unchanged for at least 6 months. None of his medications was altered. The patient had been seen in the clinic 5 weeks prior to presentation. At the time, his INR was 2,0 and he received unspecified dose of Influenza vaccine (unknown route, unknown injection site). Lot number was not available. 5 weeks after vaccination with Influenza vaccine, the subject was hospitalized after becoming unresponsive at home. At the admission, the patient had been unresponsive for approximately 1 hour. The patient was experiencing rectal bleeding for the previous 2 days. The initial international normalized ratio (INR) was greater than 15; INR values over the previous 6 months were relatively stable. Relevant test were performed and showed the following results: Hemoglobin: 8,3 g/dL (normal range 14-18); Hematocrit: 24% (normal range 42-52); Platelet count: 412 x 10^3 /uL (normal range 150-430); low serum albumin: 3,1 g/dL (normal range 3,5-5,0); total bilirubin: 0,8 mg/dL (normal range 0,2-1,0); aspartate aminotransferase: 16 IU/L (normal range 10-42); alanine aminotransferase:12 IU/L (normal range 10-40); blood pressure: 166/60 mm Hg, heart rate: 62 beats/min; respiration rate:16 breaths/min; temperature was not documented. A non-contrast computed tomography scan of the head revealed a large parenchymal hemorrhagic infarction involving the left temporal, parietal, and occipital lobes. The radiologist noted a significant mass effect including 12mm rightward midline shift and impending uncal herniation. The subject was treated in the emergency department with Nitroglycerin infusion to maintain systolic blood pressure in the range of 140-160 mm Hg as well as the infusion of 4 units of fresh frozen plasma and 10 mg of vitamin K. Following a neurosurgery evaluation, it was determined that nothing meaningful could be done to alter the patient's outcome positively. Comfort measures were implemented and the patient died approximately 17 hours after admission. The author considered the events were possibly related to the interaction between Warfarin and vaccination with Influenza vaccine.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Blood culture negative, Culture urine negative, Diarrhoea, Hypophagia, Lethargy
Clinical narrative: -103 degree temperature - diarrhea -  loss of appetite - severe stomach pain - weight loss - weak/pale - lasted over 7 days. Hospital stay was 4 days. IV fluid w/meds.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Pyrexia, Rotavirus test positive
Clinical narrative: -103 degree temperature - diarrhea -  loss of appetite - severe stomach pain - weight loss - weak/pale - lasted over 7 days. Hospital stay was 4 days. IV fluid w/meds.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Abdominal pain upper, Anorexia, Asthenia, Body temperature increased, Diarrhoea
Clinical narrative: -103 degree temperature - diarrhea -  loss of appetite - severe stomach pain - weight loss - weak/pale - lasted over 7 days. Hospital stay was 4 days. IV fluid w/meds.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Pallor, Rotavirus test positive, Weight decreased
Clinical narrative: -103 degree temperature - diarrhea -  loss of appetite - severe stomach pain - weight loss - weak/pale - lasted over 7 days. Hospital stay was 4 days. IV fluid w/meds.
Age: 48.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Hypotension, Injection site reaction
Clinical narrative: Information has been received from a registered pharmacist concerning a 48 year old female who on 08-JUN-2009 was vaccinated with PNEUMOVAX (lot# 662745/1576X, route and site of administration not reported). Concomitant therapy included unspecified chemotherapy. On 09-JUN-2009, the patient went to the emergency room and presented with hypotension and local reaction at the injection site. The patient required I.V.  BENADRYL but not hospitalized. The patient's outcome was unknown because patient has not returned to the office yet for chemotherapy. Upon internal review, hypotension and local reaction at the injection site treated with I.V. BENADRYL were determined to be an other important medical event. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: MEN
Symptoms: Meningitis bacterial
Clinical narrative: Initial report was received 10 June 2009 from a newspaper article: A female college freshman student had received an unspecified meningococcal vaccine (manufacturer, lot number, route/site and date of administration not reported) and an unspecified amount of time later, she developed a probable case of bacterial meningitis. The specific bacteria and strain were not identified in the report. The patient had been a freshman student and resided in the college dormitory. According to the report, the patient had been admitted to the hospital on "Monday". The patient's outcome was not reported and no further information was provided in the report. The reporter for this case is the same as case number 2009-02504. Documents held by sender: None.  6/25/09-Follow-up information from  Meningitis Branch staff indicated that the cause of the bacterial meningitis was serogroup B.
Sex: M
Vaccine: MEN
Symptoms: Meningitis bacterial
Clinical narrative: Initial report was received 10 June 2009 from a newspaper article: Two college students (one identified as a male and the other unidentified), had received an unspecified meningococcal vaccine (manufacturer, lot number, route/site and date of administration not reported), and an unspecified amount of time later, they were diagnosed with bacterial meningitis. According to the report, these two students had been diagnosed "earlier this year" and had fully recovered. The specific bacteria and strain were not identified in the report. No additional information was provided at the time of the report. The reporter for this case is the same as case number 2009-02503. Documents held by sender: None. 6/25/09-Follow-up information fromMeningitis Branch staff indicated that the cause of the bacterial meningitis was serogroup B.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Anaemia, Blood test, Condition aggravated, Drug exposure during pregnancy
Clinical narrative: Information has been received from a 21 year old female patient with a history of previous miscarriage and anaemia who in February 2009, was vaccinated with the first dose of GARDASIL (lot# not available). There was no concomitant medication. The Health Department that administered the vaccine did a pregnancy test but it came back negative. The patient thinks she may have been about 2 weeks pregnant at the time of the injection. On 07-MAY-2009 the patient had a miscarriage and the physician also discovered she had an anemia. A blood test and "D & C" (unspecified) were performed (no results provided). The patient sought unspecified medical attention. Upon internal review miscarriage was considered to be another important medical event. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Pregnancy test negative, Uterine dilation and curettage
Clinical narrative: Information has been received from a 21 year old female patient with a history of previous miscarriage and anaemia who in February 2009, was vaccinated with the first dose of GARDASIL (lot# not available). There was no concomitant medication. The Health Department that administered the vaccine did a pregnancy test but it came back negative. The patient thinks she may have been about 2 weeks pregnant at the time of the injection. On 07-MAY-2009 the patient had a miscarriage and the physician also discovered she had an anemia. A blood test and "D & C" (unspecified) were performed (no results provided). The patient sought unspecified medical attention. Upon internal review miscarriage was considered to be another important medical event. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abnormal behaviour, Electroencephalogram normal, Nuclear magnetic resonance imaging normal, Petit mal epilepsy, Unresponsive to stimuli
Clinical narrative: Information has been received from a physician concerning a 15 year old female with depression who in November 2007 was vaccinated with her first dose of GARDASIL intramuscular in her deltoid. Concomitant therapy included LEXAPRO. The patient was vaccinated with all three doses of GARDASIL (lot numbers not available) intramuscular into her deltoid. The patient received her first two doses of GARDASIL along with MENACTRA, Tdap (manufacturer unknown). Three or four months after receiving her third dose of GARDASIL intramuscular (in approximately August 2008 or September 2008), the patient experienced absent seizure. The child became non-reactive, non-responsive and distant. She did not received any other vaccines along with her third dose. She received an electroencephalography and an magnetic resonance imaging which were normal. The outcome of the patient was not reported. The patient was currently seeing a neurologist who felt that the seizure was caused by stress rather than from the vaccine. Upon internal review absent seizure was considered to be an other important medical event. Additional information has been requested.  10/19/09 Neurology consultation records received, service dates 4/7/09 to 10/5/09. Assessment: Partial epilepsy. Witnessed seizure with vocalization, elbow flexed, hand clenched, turned head to right side, incoherent. sweating and drooling.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abnormal behaviour, Acne, Convulsion, Electroencephalogram abnormal, Epilepsy
Clinical narrative: Information has been received from a physician concerning a 15 year old female with depression who in November 2007 was vaccinated with her first dose of GARDASIL intramuscular in her deltoid. Concomitant therapy included LEXAPRO. The patient was vaccinated with all three doses of GARDASIL (lot numbers not available) intramuscular into her deltoid. The patient received her first two doses of GARDASIL along with MENACTRA, Tdap (manufacturer unknown). Three or four months after receiving her third dose of GARDASIL intramuscular (in approximately August 2008 or September 2008), the patient experienced absent seizure. The child became non-reactive, non-responsive and distant. She did not received any other vaccines along with her third dose. She received an electroencephalography and an magnetic resonance imaging which were normal. The outcome of the patient was not reported. The patient was currently seeing a neurologist who felt that the seizure was caused by stress rather than from the vaccine. Upon internal review absent seizure was considered to be an other important medical event. Additional information has been requested.  10/19/09 Neurology consultation records received, service dates 4/7/09 to 10/5/09. Assessment: Partial epilepsy. Witnessed seizure with vocalization, elbow flexed, hand clenched, turned head to right side, incoherent. sweating and drooling.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Immediate post-injection reaction, Loss of consciousness, Nuclear magnetic resonance imaging normal, Partial seizures
Clinical narrative: Information has been received from a physician concerning a 15 year old female with depression who in November 2007 was vaccinated with her first dose of GARDASIL intramuscular in her deltoid. Concomitant therapy included LEXAPRO. The patient was vaccinated with all three doses of GARDASIL (lot numbers not available) intramuscular into her deltoid. The patient received her first two doses of GARDASIL along with MENACTRA, Tdap (manufacturer unknown). Three or four months after receiving her third dose of GARDASIL intramuscular (in approximately August 2008 or September 2008), the patient experienced absent seizure. The child became non-reactive, non-responsive and distant. She did not received any other vaccines along with her third dose. She received an electroencephalography and an magnetic resonance imaging which were normal. The outcome of the patient was not reported. The patient was currently seeing a neurologist who felt that the seizure was caused by stress rather than from the vaccine. Upon internal review absent seizure was considered to be an other important medical event. Additional information has been requested.  10/19/09 Neurology consultation records received, service dates 4/7/09 to 10/5/09. Assessment: Partial epilepsy. Witnessed seizure with vocalization, elbow flexed, hand clenched, turned head to right side, incoherent. sweating and drooling.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash, Speech disorder
Clinical narrative: Information has been received from a physician concerning a 15 year old female with depression who in November 2007 was vaccinated with her first dose of GARDASIL intramuscular in her deltoid. Concomitant therapy included LEXAPRO. The patient was vaccinated with all three doses of GARDASIL (lot numbers not available) intramuscular into her deltoid. The patient received her first two doses of GARDASIL along with MENACTRA, Tdap (manufacturer unknown). Three or four months after receiving her third dose of GARDASIL intramuscular (in approximately August 2008 or September 2008), the patient experienced absent seizure. The child became non-reactive, non-responsive and distant. She did not received any other vaccines along with her third dose. She received an electroencephalography and an magnetic resonance imaging which were normal. The outcome of the patient was not reported. The patient was currently seeing a neurologist who felt that the seizure was caused by stress rather than from the vaccine. Upon internal review absent seizure was considered to be an other important medical event. Additional information has been requested.  10/19/09 Neurology consultation records received, service dates 4/7/09 to 10/5/09. Assessment: Partial epilepsy. Witnessed seizure with vocalization, elbow flexed, hand clenched, turned head to right side, incoherent. sweating and drooling.
Sex: F
Vaccine: HPV4
Symptoms: Amnesia, Convulsion
Clinical narrative: Information has been received from a pharmacist concerning his friend's daughter who on unspecified date was vaccinated with a dose of GARDASIL (lot# not reported). After she got the vaccine while she was waiting at the physician's office she experienced seizure. Couple days later she experienced lost of short term memory. At the time on the report on 17-JUN-2009 the patient had not recovered. Upon internal review, seizure was considered to be an Other Important Medical Event. No further information is available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site infection, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning two patients who within the last 30 days were vaccinated with ZOSTAVAX (Merck) (subcutaneously, 0.65ml, lot # not reported). On the same day as vaccination the patients had an infection at the injection site. The patients experienced initially redness and swelling at the injection site. The infection had been treated with 2 antimicrobial (unspecified). The pharmacist believed the infection could have been "staph" because of the 2 antimicrobial (unspecified) used and the potency of these antimicrobial (unspecified). The patients had sought medical attention via phone calls. The pharmacist considered the infections to be other important medical events. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Abdominal pain upper, Anorexia, Asthenia, Diarrhoea, Immunisation reaction
Clinical narrative: - Fever of 103 degrees - diarrhea - loss of appetite - severe stomach pain - weight loss - weak/pale - lasted over 7 days. Hospital stay was 3 days, treated with IV. and meds.  7/22/09 Hospital records received to 5/18/19 - 5/19/09 Assessment: Gastroenteritis, likely rotavirus. Patient presented with fever and diarrhea. Drinking has decreased. Pale.  ICD-9 Codes: "6589 Noninfectious gastroenteritis and colitis".
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Pallor, Pyrexia, Rotavirus test positive, Weight decreased
Clinical narrative: - Fever of 103 degrees - diarrhea - loss of appetite - severe stomach pain - weight loss - weak/pale - lasted over 7 days. Hospital stay was 3 days, treated with IV. and meds.  7/22/09 Hospital records received to 5/18/19 - 5/19/09 Assessment: Gastroenteritis, likely rotavirus. Patient presented with fever and diarrhea. Drinking has decreased. Pale.  ICD-9 Codes: "6589 Noninfectious gastroenteritis and colitis".
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Anaemia, Bedridden, Chest X-ray, Gait disturbance, Grip strength decreased
Clinical narrative: 112408 - Pt c/o pain in feet; 112508 pain cont, now can't pick up objects with hands; 112608 requires assist to walk into ER; 112708 is now bedbound. Test, plasmapheresis - anemia - RBC given - rehab  7/7/09 MR received for DOS 12/20/2008-01/08/2009 with D/C DX:  Guillain_Barre Syndrome, axonal type.  HTN.  DM.  Mild tachycardia.  Pt presented with progressive weakness in LEs, then hands. PE (+) for decreased strength and sensation. Absent reflexes. Pt c/o severe pain and muscle spasm of lower extremities, 1-2+ LE edema. DVTs noted in LEs tx with anticoagulants. Plasmapheresis with little improvement. One dose of IVIG with some improvement.  Transferred for rehab on 1/8/09.    ICD9:  V5783.  3570. 4019.  /
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Lumbar puncture, Pain in extremity, Plasmapheresis, Transfusion
Clinical narrative: 112408 - Pt c/o pain in feet; 112508 pain cont, now can't pick up objects with hands; 112608 requires assist to walk into ER; 112708 is now bedbound. Test, plasmapheresis - anemia - RBC given - rehab  7/7/09 MR received for DOS 12/20/2008-01/08/2009 with D/C DX:  Guillain_Barre Syndrome, axonal type.  HTN.  DM.  Mild tachycardia.  Pt presented with progressive weakness in LEs, then hands. PE (+) for decreased strength and sensation. Absent reflexes. Pt c/o severe pain and muscle spasm of lower extremities, 1-2+ LE edema. DVTs noted in LEs tx with anticoagulants. Plasmapheresis with little improvement. One dose of IVIG with some improvement.  Transferred for rehab on 1/8/09.    ICD9:  V5783.  3570. 4019.  /
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Patient received ZOSTAVAX vaccine on 5/26/09 and began having adverse reactions on 5/28/09 of body aches, headache and fever.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site swelling
Clinical narrative: R-Deltoid (Dtap) whole arm swollen noticed 6/16/09 received imm on 6/15/09 4pm gave Rx Dermatop - watch give tylenol Benadryl as needed.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site papule, Skin lesion, Urticaria
Clinical narrative: Localized urticarial lesion w/o any systemic symptoms. Non pruritic papular lesion surrounds the punctum where MMR was given.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Mass, Pruritus, Skin warm, Swelling
Clinical narrative: Swollen, reddened, feverish knot with redness going to axillary area. Itchy 3 1/2X2 " knot redness 7 1/2" X 4 1/2"  no streaking down arm (bubbly looking similar to cellulitis)  however 7 1/2 X 4 1/2 reddened area.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Immediate post-injection reaction, Insomnia, Oedema peripheral
Clinical narrative: Vaccine administered 6/17. Arm turned pink immediately following, then cleared. Several hours later arm turned red and slightly swollen in a 3" diameter. Area is very itchy and burns. Patient had difficulty sleeping for 2 nights. Rash has still not cleared. Patient will now begin hydrocortisone cream.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Skin discolouration
Clinical narrative: Vaccine administered 6/17. Arm turned pink immediately following, then cleared. Several hours later arm turned red and slightly swollen in a 3" diameter. Area is very itchy and burns. Patient had difficulty sleeping for 2 nights. Rash has still not cleared. Patient will now begin hydrocortisone cream.
Age: 9.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Vaccine given to early per manufacturer.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site urticaria, Myalgia, Rash macular, Swelling
Clinical narrative: Received TDAP on 6/9/09 noticed hives to injection site and just below injection site to anterior upper arm. Had swelling blotchiness to areas and muscle aches. 6/15 Has slight red area to anterior upper arm today. To report if any further redness that does not go away.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Left shoulder swelling.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left arm red and swollen.
Age: 11.0
Sex: M
Vaccine: IPV, MMR, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: (R) deltoid swollen, warm, red and hard to touch-client mother encouraged to seek help at MD or ER. No drainage noted at injection site.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: 5/4/09- Pt c/o L upper arm redness
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site swelling
Clinical narrative: SEEN IN OUR OFFICE FOR 4 YEAR OLD WELL CHILD VISIT.  RECEIVED 4 YEAR OLD BOOSTERS: Dtap, MMR, IPV, AND Varivax ON 6/17/09.  WOKE UP ON 6/19/09 WITH SWOLLEN LEFT UPPER ARM.  DIAGNOSED WITH LEFT UPPER CELLULITIS TREATED WITH AUGMENTIN.
Age: 46.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Skin irritation
Clinical narrative: The patient is a 46-year-old man who had Pneumovax vaccine here on June 17.  Within 1 or 2 days, he developed localized redness and irritation that has been gradually enlarging.  He had a tetanus in the other arm with no problem. 6/20/09 prescribed dicloxacillin 500 q.i.d. to take on an empty stomach for 8 days.  6/21/09 pt stated "it is less red and feels better"
Age: 1.42
Sex: M
Vaccine: MMR, PPV, VARCEL
Symptoms: Blood culture, Chest X-ray, Convulsion, Culture urine
Clinical narrative: Seizure 9 days after receiving MMR, Prevnar and Varivax vaccinations.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Rash erythematous, Rash maculo-papular
Clinical narrative: Patient received the shingles vaccine on Monday, and she came back today on 6/11/09 due to allergic reaction. She was told if she had any problem with shingles vaccine to return within three days, and unfortunately she did. After examination, Dr. decided to have patient placed on medrol dose pack and hydroxyzine. On physical exam, patient had red macular papular rash on neck area, and hands bilaterally. She was given decadron shot, Explained to patient side effects of decadron shot. lot#8797 expires nov,2010. decadron shot given in right gluteal area. patient tolerated well temp 97.8.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Crying, Diarrhoea, Erythema, Irritability, Pyrexia
Clinical narrative: Child's mother reports 3 to 4 hours after reciving immunizations yesterday, child started running fever ranging from 99 to 101, Child very fussy and cranky.  Mother states child is crying like she is in pain.  This morning child is still running fever ranging from 99 to 101 and mother reports fever is not relieved by infant Tylenol.  States fever does go down after Tylenol dose but rebounds to 101 again.  Child started having diarrhea stools last evening and mother reports child has had seven diarrhea stools this morning.  Time is now 09:30 A.M.  At 10:30 A.M. childs mother again calls health department reporting child's inner thighs are red and swollen and diaper area is bright red.  Child remains very fussy.  Mother is instructed to take child to her physician or to an emergency room for evaluation.
Age: 19.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Chest discomfort, Feeling cold, Injection site pain, Palpitations
Clinical narrative: pt's mother called pt complained of soreness at the site and feeling cold. The next day she c/o her heart racing and feeling some discomfort in her chest.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Swelling face
Clinical narrative: Called in by Father, stated school nurse called that daughter face was swollen. Father instructed to take daughter to ER.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Received a Shingles vaccination at 2:30 PM last Friday (06/19/09) and am STILL experiencing headaches today, Tuesday (06/23/09).  I was told at the time of the vaccination I my experience a slight fever (I did NOT) but nothing was mentioned about a possible headache.  The paperwork stated a headache is experienced in 1 out of 70 patients.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Fatigue, Headache, Nightmare
Clinical narrative: Pt had the vaccine around 9:00 am, became tired, and went to sleep from 5 to 7pm, then back to bed later that night. Complained of excessive night mares.  Had fatigue the next day, chills no fever and complained of a headache, all which lasted until noon on Saturday the 20th.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV1
Symptoms: Crying, Diet refusal, Immunisation reaction
Clinical narrative: Inconsolable crying, would not nurse or drink.  Seen by physician within 4 hours of onset of symptoms.  Eposide lasting 24 hours.  Physican dx pertussis reaction.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Arthropod bite, Back pain, Chills, Decreased appetite, Dizziness
Clinical narrative: She had tdap immunization yesterday. At 1100 pm she developed onset of HA/dizziness/chills/ nauseated. She also reported to her mom some lower back pain and frequency. No dysuria. Temp normal. Today she feels better, slight HA, slight dizziness. Right arm has very slight swelling noted/tender to touch but no redness. She was restless and did not sleep well. She feels better today, but still slightly dizzy when she gets up quickly. She had tick bite a few weeks ago; no rash.  She has poor appetite; has not eaten today.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness postural, Headache, Nausea, Oedema peripheral, Restlessness
Clinical narrative: She had tdap immunization yesterday. At 1100 pm she developed onset of HA/dizziness/chills/ nauseated. She also reported to her mom some lower back pain and frequency. No dysuria. Temp normal. Today she feels better, slight HA, slight dizziness. Right arm has very slight swelling noted/tender to touch but no redness. She was restless and did not sleep well. She feels better today, but still slightly dizzy when she gets up quickly. She had tick bite a few weeks ago; no rash.  She has poor appetite; has not eaten today.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Sleep disorder, Tenderness
Clinical narrative: She had tdap immunization yesterday. At 1100 pm she developed onset of HA/dizziness/chills/ nauseated. She also reported to her mom some lower back pain and frequency. No dysuria. Temp normal. Today she feels better, slight HA, slight dizziness. Right arm has very slight swelling noted/tender to touch but no redness. She was restless and did not sleep well. She feels better today, but still slightly dizzy when she gets up quickly. She had tick bite a few weeks ago; no rash.  She has poor appetite; has not eaten today.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: COMPLAIN OF REDNESS, WARMTH, AND SWELLING TO RIGHT ARM 1 DAY AFTER RECEIVING VACCINES. REDNESS COMPLETELY AROUND ARM FROM SHOULDER TO ELBOW. IN DOCTOR'S OFFICE, RIGHT ARM WAS 4CM BIGGER THAN LEFT ARM.
Sex: F
Vaccine: HEP
Symptoms: Death
Clinical narrative: UNKNOWN 6/29/09-autopsy report received-COD-Undetermined.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Rash, Rash erythematous
Clinical narrative: Client developed a few small, raised, red dots on the face and in the hair line area.
Age: 0.92
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV
Symptoms: Abnormal behaviour
Clinical narrative: Per Mother and Grandmother after receiving second series of vaccinations "child will not play as before".
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Acoustic stimulation tests abnormal, Angiogram normal, Balance disorder, Balance disorder, Deafness unilateral
Clinical narrative: Sudden Hearing Loss and balance problems 5 days after injection. MRI and MRA normal. ETN doctors (started week folowing SHL) put me on steriods, antibotics, diaretics, B vitamins, and ear infusion of steriods. After 5 weeks I still have profound-severe hearing loss. Dr. should provide manufacturing vaccination details.  7/2/09 Consultant records received DOS 5/22/09 6/2/09. Assessment: Nystagmus, hearing loss.  Follow-up: Loss of hearing right side - severe loss, profound.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Electronystagmogram abnormal, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Sudden hearing loss
Clinical narrative: Sudden Hearing Loss and balance problems 5 days after injection. MRI and MRA normal. ETN doctors (started week folowing SHL) put me on steriods, antibotics, diaretics, B vitamins, and ear infusion of steriods. After 5 weeks I still have profound-severe hearing loss. Dr. should provide manufacturing vaccination details.  7/2/09 Consultant records received DOS 5/22/09 6/2/09. Assessment: Nystagmus, hearing loss.  Follow-up: Loss of hearing right side - severe loss, profound.
Age: 23.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Blood test, Chills, Influenza like illness, Oropharyngeal pain, Pyrexia
Clinical narrative: 12 Jun 09/1:32pm-Anthrax vax rec'd IM L. Delt.  13 Jun 09/2:00am-Sore throat/fever/chills/flu-like symptoms noticed.  Went to ER later in the day when symptoms got worse.  The Hospital gave "IV fluids, Benedryl pills, & pills for headache" They also took blood for testing and X-rays - results weren't made known to patient.
Age: 23.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: X-ray
Clinical narrative: 12 Jun 09/1:32pm-Anthrax vax rec'd IM L. Delt.  13 Jun 09/2:00am-Sore throat/fever/chills/flu-like symptoms noticed.  Went to ER later in the day when symptoms got worse.  The Hospital gave "IV fluids, Benedryl pills, & pills for headache" They also took blood for testing and X-rays - results weren't made known to patient.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, PNC
Symptoms: Blood product transfusion, C-reactive protein increased, Conjunctivitis, Echocardiogram normal, Kawasaki's disease
Clinical narrative: high grade fever, polymorphous rash, bilateral bulbar conjunctivitis, cervical lymphadenopathy, erythematous palms and soles, swelling of hands and feet (consistent with Kawasaki disease); given IVIG at 2g/kg and ASA 100mg/kg with improvement of symptoms. no cardiac abnormalities on echo.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, PNC
Symptoms: Palmar erythema, Pyrexia, Rash, Red blood cell sedimentation rate increased
Clinical narrative: high grade fever, polymorphous rash, bilateral bulbar conjunctivitis, cervical lymphadenopathy, erythematous palms and soles, swelling of hands and feet (consistent with Kawasaki disease); given IVIG at 2g/kg and ASA 100mg/kg with improvement of symptoms. no cardiac abnormalities on echo.