chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4
Symptoms: Lethargy, Lumbar puncture normal, Mental status changes, Nuclear magnetic resonance imaging abnormal, Pyrexia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 year old female with PANMIST DM allergy and with no known medical history was vaccinated with a first dose of GARDASIL vaccine (lot# 661766/0652X) in the right arm (route not reported) on 27-May-2009. Concomitant vaccinations included a first dose of ADACEL (lot# reported as C3068AA) and a first dose of MENACTRA (lot# reported as U2869AA). On 04-Jun-2009, the patient experienced acute disseminated encephalomyelitis, abasia, asthenia, autonomic nervous system imbalance, clonus, convulsion, coordination abnormal, fatigue, headache, hyperreflexia, lethargy, mental status changes, pyrexia, tachycardia, body temperature increased and chills. Seven days after immunization, the patient started mental status changes with fever (104), headache, lethargy, inability to walk, discoordination, signs of autonomic instability. The patient went to emergency room. Two events of brief seizure with mouth pulling to the left separated by 30 minutes occurring on one day about 1 mouth following onset of symptoms. Fatigue, intermittent tachycardia, left-sided headache and general weakness have persisted, although improved over the past 3 months. She was diffuse, symmetric hyperreflexia in all extremities with 1 beat clonus of the right ankle. Diagnosis of ADEM was made. No treatment was given. The listing indicated that one or more of the events required hospitalization (05-JUN-2009 and 13-JUL-2009) and was considered to be immediately life-threatening. The originally reporting source was not provided. The VAERS ID# is 356939. No further information is available. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4
Symptoms: Acute disseminated encephalomyelitis, Ataxia, Central nervous system lesion, Fatigue, Headache
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 year old female with PANMIST DM allergy and with no known medical history was vaccinated with a first dose of GARDASIL vaccine (lot# 661766/0652X) in the right arm (route not reported) on 27-May-2009. Concomitant vaccinations included a first dose of ADACEL (lot# reported as C3068AA) and a first dose of MENACTRA (lot# reported as U2869AA). On 04-Jun-2009, the patient experienced acute disseminated encephalomyelitis, abasia, asthenia, autonomic nervous system imbalance, clonus, convulsion, coordination abnormal, fatigue, headache, hyperreflexia, lethargy, mental status changes, pyrexia, tachycardia, body temperature increased and chills. Seven days after immunization, the patient started mental status changes with fever (104), headache, lethargy, inability to walk, discoordination, signs of autonomic instability. The patient went to emergency room. Two events of brief seizure with mouth pulling to the left separated by 30 minutes occurring on one day about 1 mouth following onset of symptoms. Fatigue, intermittent tachycardia, left-sided headache and general weakness have persisted, although improved over the past 3 months. She was diffuse, symmetric hyperreflexia in all extremities with 1 beat clonus of the right ankle. Diagnosis of ADEM was made. No treatment was given. The listing indicated that one or more of the events required hospitalization (05-JUN-2009 and 13-JUL-2009) and was considered to be immediately life-threatening. The originally reporting source was not provided. The VAERS ID# is 356939. No further information is available. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4
Symptoms: Lumbar puncture normal, Nuclear magnetic resonance imaging abnormal, Pyrexia, Tachycardia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 year old female with PANMIST DM allergy and with no known medical history was vaccinated with a first dose of GARDASIL vaccine (lot# 661766/0652X) in the right arm (route not reported) on 27-May-2009. Concomitant vaccinations included a first dose of ADACEL (lot# reported as C3068AA) and a first dose of MENACTRA (lot# reported as U2869AA). On 04-Jun-2009, the patient experienced acute disseminated encephalomyelitis, abasia, asthenia, autonomic nervous system imbalance, clonus, convulsion, coordination abnormal, fatigue, headache, hyperreflexia, lethargy, mental status changes, pyrexia, tachycardia, body temperature increased and chills. Seven days after immunization, the patient started mental status changes with fever (104), headache, lethargy, inability to walk, discoordination, signs of autonomic instability. The patient went to emergency room. Two events of brief seizure with mouth pulling to the left separated by 30 minutes occurring on one day about 1 mouth following onset of symptoms. Fatigue, intermittent tachycardia, left-sided headache and general weakness have persisted, although improved over the past 3 months. She was diffuse, symmetric hyperreflexia in all extremities with 1 beat clonus of the right ankle. Diagnosis of ADEM was made. No treatment was given. The listing indicated that one or more of the events required hospitalization (05-JUN-2009 and 13-JUL-2009) and was considered to be immediately life-threatening. The originally reporting source was not provided. The VAERS ID# is 356939. No further information is available. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram, Deep vein thrombosis, Echocardiogram, Intensive care, Pain in extremity
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 25 year old female with no known drug allergy and a history of factor v Leiden heterozygote disease, deep vein thrombosis 18 months prior, pregnancy (no medications for anti-coagulation prior to pregnancy) and postpartum who on 02-JUN-2009 was vaccinated intramuscularly in left arm with the second dose of GARDASIL (LOT# 660389/1968U). Concomitant therapy included subcutaneous heparin secondary to post-partum. On 07-JUN-2009 the patient had symptoms of leg pain. On 12-JUN-2009, 10 days post vaccination, the patient was hospitalized with extensive deep vein thrombosis and bilateral pulmonary embolism. The patient required thrombolysis with total parenteral alimentation (TPA), intraventricular catheter (IVC) filter placement, echocardiogram and computerized tomogram (CT scans) with the positive result for bilateral pulmonary embolism. Laboratory tests and diagnosis studies were done. Doppler ultrasound in right leg had a positive result for deep vein thrombosis; complete blood cell count (CBC) and "CMP" were within normal limit; troponin was high at 0.44; prothrombin time (PT) and activated partial thromboplastin time (APTT) were elevated; oxygen saturation test was low with 70's; and electrocardiogram (EKG) was normal. The patient stayed in intensive care unit and was prescribed anti-coagulation with COUMADIN for 6 months. On 16-OCT-2009 hospital records for dates of 12-JUN-2009 to 15-JUN-2009 were received. It was reported that the patient also presented with signs of dyspnoea, cough, chest tightness and right leg pain after 10 days of vaccination. The patient treated with IV heparin, subcutaneous LOVENOX and IVC filter placement. Chest discomfort, computerized tomogram, cough, deep vein thrombosis, dyspnoea, echocardiogram, intensive care, pain in extremity, pulmonary embolism and thrombolysis were considered to be immediately life-threatening. The patient required an emergency room visit. The original reporting source was not provided. This was originally reported by a consumer. The VAERS ID is 358983, A lot check has been initiated. Follow-up information was received for lot check result. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pulmonary embolism, Thrombolysis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 25 year old female with no known drug allergy and a history of factor v Leiden heterozygote disease, deep vein thrombosis 18 months prior, pregnancy (no medications for anti-coagulation prior to pregnancy) and postpartum who on 02-JUN-2009 was vaccinated intramuscularly in left arm with the second dose of GARDASIL (LOT# 660389/1968U). Concomitant therapy included subcutaneous heparin secondary to post-partum. On 07-JUN-2009 the patient had symptoms of leg pain. On 12-JUN-2009, 10 days post vaccination, the patient was hospitalized with extensive deep vein thrombosis and bilateral pulmonary embolism. The patient required thrombolysis with total parenteral alimentation (TPA), intraventricular catheter (IVC) filter placement, echocardiogram and computerized tomogram (CT scans) with the positive result for bilateral pulmonary embolism. Laboratory tests and diagnosis studies were done. Doppler ultrasound in right leg had a positive result for deep vein thrombosis; complete blood cell count (CBC) and "CMP" were within normal limit; troponin was high at 0.44; prothrombin time (PT) and activated partial thromboplastin time (APTT) were elevated; oxygen saturation test was low with 70's; and electrocardiogram (EKG) was normal. The patient stayed in intensive care unit and was prescribed anti-coagulation with COUMADIN for 6 months. On 16-OCT-2009 hospital records for dates of 12-JUN-2009 to 15-JUN-2009 were received. It was reported that the patient also presented with signs of dyspnoea, cough, chest tightness and right leg pain after 10 days of vaccination. The patient treated with IV heparin, subcutaneous LOVENOX and IVC filter placement. Chest discomfort, computerized tomogram, cough, deep vein thrombosis, dyspnoea, echocardiogram, intensive care, pain in extremity, pulmonary embolism and thrombolysis were considered to be immediately life-threatening. The patient required an emergency room visit. The original reporting source was not provided. This was originally reported by a consumer. The VAERS ID is 358983, A lot check has been initiated. Follow-up information was received for lot check result. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Activated partial thromboplastin time prolonged, Angiogram, Chest discomfort, Computerised tomogram abnormal, Cough
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 25 year old female with no known drug allergy and a history of factor v Leiden heterozygote disease, deep vein thrombosis 18 months prior, pregnancy (no medications for anti-coagulation prior to pregnancy) and postpartum who on 02-JUN-2009 was vaccinated intramuscularly in left arm with the second dose of GARDASIL (LOT# 660389/1968U). Concomitant therapy included subcutaneous heparin secondary to post-partum. On 07-JUN-2009 the patient had symptoms of leg pain. On 12-JUN-2009, 10 days post vaccination, the patient was hospitalized with extensive deep vein thrombosis and bilateral pulmonary embolism. The patient required thrombolysis with total parenteral alimentation (TPA), intraventricular catheter (IVC) filter placement, echocardiogram and computerized tomogram (CT scans) with the positive result for bilateral pulmonary embolism. Laboratory tests and diagnosis studies were done. Doppler ultrasound in right leg had a positive result for deep vein thrombosis; complete blood cell count (CBC) and "CMP" were within normal limit; troponin was high at 0.44; prothrombin time (PT) and activated partial thromboplastin time (APTT) were elevated; oxygen saturation test was low with 70's; and electrocardiogram (EKG) was normal. The patient stayed in intensive care unit and was prescribed anti-coagulation with COUMADIN for 6 months. On 16-OCT-2009 hospital records for dates of 12-JUN-2009 to 15-JUN-2009 were received. It was reported that the patient also presented with signs of dyspnoea, cough, chest tightness and right leg pain after 10 days of vaccination. The patient treated with IV heparin, subcutaneous LOVENOX and IVC filter placement. Chest discomfort, computerized tomogram, cough, deep vein thrombosis, dyspnoea, echocardiogram, intensive care, pain in extremity, pulmonary embolism and thrombolysis were considered to be immediately life-threatening. The patient required an emergency room visit. The original reporting source was not provided. This was originally reported by a consumer. The VAERS ID is 358983, A lot check has been initiated. Follow-up information was received for lot check result. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Deep vein thrombosis, Dyspnoea, Electrocardiogram normal, Full blood count normal, Intensive care
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 25 year old female with no known drug allergy and a history of factor v Leiden heterozygote disease, deep vein thrombosis 18 months prior, pregnancy (no medications for anti-coagulation prior to pregnancy) and postpartum who on 02-JUN-2009 was vaccinated intramuscularly in left arm with the second dose of GARDASIL (LOT# 660389/1968U). Concomitant therapy included subcutaneous heparin secondary to post-partum. On 07-JUN-2009 the patient had symptoms of leg pain. On 12-JUN-2009, 10 days post vaccination, the patient was hospitalized with extensive deep vein thrombosis and bilateral pulmonary embolism. The patient required thrombolysis with total parenteral alimentation (TPA), intraventricular catheter (IVC) filter placement, echocardiogram and computerized tomogram (CT scans) with the positive result for bilateral pulmonary embolism. Laboratory tests and diagnosis studies were done. Doppler ultrasound in right leg had a positive result for deep vein thrombosis; complete blood cell count (CBC) and "CMP" were within normal limit; troponin was high at 0.44; prothrombin time (PT) and activated partial thromboplastin time (APTT) were elevated; oxygen saturation test was low with 70's; and electrocardiogram (EKG) was normal. The patient stayed in intensive care unit and was prescribed anti-coagulation with COUMADIN for 6 months. On 16-OCT-2009 hospital records for dates of 12-JUN-2009 to 15-JUN-2009 were received. It was reported that the patient also presented with signs of dyspnoea, cough, chest tightness and right leg pain after 10 days of vaccination. The patient treated with IV heparin, subcutaneous LOVENOX and IVC filter placement. Chest discomfort, computerized tomogram, cough, deep vein thrombosis, dyspnoea, echocardiogram, intensive care, pain in extremity, pulmonary embolism and thrombolysis were considered to be immediately life-threatening. The patient required an emergency room visit. The original reporting source was not provided. This was originally reported by a consumer. The VAERS ID is 358983, A lot check has been initiated. Follow-up information was received for lot check result. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Metabolic function test, Oxygen saturation decreased, Pain in extremity, Prothrombin time prolonged, Pulmonary embolism
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 25 year old female with no known drug allergy and a history of factor v Leiden heterozygote disease, deep vein thrombosis 18 months prior, pregnancy (no medications for anti-coagulation prior to pregnancy) and postpartum who on 02-JUN-2009 was vaccinated intramuscularly in left arm with the second dose of GARDASIL (LOT# 660389/1968U). Concomitant therapy included subcutaneous heparin secondary to post-partum. On 07-JUN-2009 the patient had symptoms of leg pain. On 12-JUN-2009, 10 days post vaccination, the patient was hospitalized with extensive deep vein thrombosis and bilateral pulmonary embolism. The patient required thrombolysis with total parenteral alimentation (TPA), intraventricular catheter (IVC) filter placement, echocardiogram and computerized tomogram (CT scans) with the positive result for bilateral pulmonary embolism. Laboratory tests and diagnosis studies were done. Doppler ultrasound in right leg had a positive result for deep vein thrombosis; complete blood cell count (CBC) and "CMP" were within normal limit; troponin was high at 0.44; prothrombin time (PT) and activated partial thromboplastin time (APTT) were elevated; oxygen saturation test was low with 70's; and electrocardiogram (EKG) was normal. The patient stayed in intensive care unit and was prescribed anti-coagulation with COUMADIN for 6 months. On 16-OCT-2009 hospital records for dates of 12-JUN-2009 to 15-JUN-2009 were received. It was reported that the patient also presented with signs of dyspnoea, cough, chest tightness and right leg pain after 10 days of vaccination. The patient treated with IV heparin, subcutaneous LOVENOX and IVC filter placement. Chest discomfort, computerized tomogram, cough, deep vein thrombosis, dyspnoea, echocardiogram, intensive care, pain in extremity, pulmonary embolism and thrombolysis were considered to be immediately life-threatening. The patient required an emergency room visit. The original reporting source was not provided. This was originally reported by a consumer. The VAERS ID is 358983, A lot check has been initiated. Follow-up information was received for lot check result. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Thrombolysis, Troponin increased, Ultrasound Doppler abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 25 year old female with no known drug allergy and a history of factor v Leiden heterozygote disease, deep vein thrombosis 18 months prior, pregnancy (no medications for anti-coagulation prior to pregnancy) and postpartum who on 02-JUN-2009 was vaccinated intramuscularly in left arm with the second dose of GARDASIL (LOT# 660389/1968U). Concomitant therapy included subcutaneous heparin secondary to post-partum. On 07-JUN-2009 the patient had symptoms of leg pain. On 12-JUN-2009, 10 days post vaccination, the patient was hospitalized with extensive deep vein thrombosis and bilateral pulmonary embolism. The patient required thrombolysis with total parenteral alimentation (TPA), intraventricular catheter (IVC) filter placement, echocardiogram and computerized tomogram (CT scans) with the positive result for bilateral pulmonary embolism. Laboratory tests and diagnosis studies were done. Doppler ultrasound in right leg had a positive result for deep vein thrombosis; complete blood cell count (CBC) and "CMP" were within normal limit; troponin was high at 0.44; prothrombin time (PT) and activated partial thromboplastin time (APTT) were elevated; oxygen saturation test was low with 70's; and electrocardiogram (EKG) was normal. The patient stayed in intensive care unit and was prescribed anti-coagulation with COUMADIN for 6 months. On 16-OCT-2009 hospital records for dates of 12-JUN-2009 to 15-JUN-2009 were received. It was reported that the patient also presented with signs of dyspnoea, cough, chest tightness and right leg pain after 10 days of vaccination. The patient treated with IV heparin, subcutaneous LOVENOX and IVC filter placement. Chest discomfort, computerized tomogram, cough, deep vein thrombosis, dyspnoea, echocardiogram, intensive care, pain in extremity, pulmonary embolism and thrombolysis were considered to be immediately life-threatening. The patient required an emergency room visit. The original reporting source was not provided. This was originally reported by a consumer. The VAERS ID is 358983, A lot check has been initiated. Follow-up information was received for lot check result. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. No further information is available.
Age: 37.0
Sex: F
Vaccine: FLUN(H1N1), FLUN(H1N1)
Symptoms: Drug exposure during pregnancy, No adverse event
Clinical narrative: Patient in clinic 10/13/2009 - requested H1N1 nasal spray vaccine. Denied pregnancy at time of vaccine. Called clinic 11/10/2009 and reported pregnancy. Denied any reaction to vaccine. No adverse event reported.
Age: 37.0
Sex: F
Vaccine: FLUN(H1N1), FLUN(H1N1)
Symptoms: Contraindication to vaccination, Drug exposure during pregnancy
Clinical narrative: Patient in clinic 10/13/2009 - requested H1N1 nasal spray vaccine. Denied pregnancy at time of vaccine. Called clinic 11/10/2009 and reported pregnancy. Denied any reaction to vaccine. No adverse event reported.
Age: 22.0
Sex: F
Vaccine: FLUX, HEP, FLU3, HEP
Symptoms: Back pain, Chills, Cough, Night sweats, Pain in extremity
Clinical narrative: Within 12 hours of receiving Hepatitis B and 2009 seasonal Flu vaccine, patient experienced generalized aches and pains, leg aches, chills, night sweats, coughing to the point of vomitting. All symptoms lasted about 12 hours according to this patient.
Age: 22.0
Sex: F
Vaccine: FLUX, HEP, FLU3, HEP
Symptoms: Product quality issue, Vomiting
Clinical narrative: Within 12 hours of receiving Hepatitis B and 2009 seasonal Flu vaccine, patient experienced generalized aches and pains, leg aches, chills, night sweats, coughing to the point of vomitting. All symptoms lasted about 12 hours according to this patient.
Age: 22.0
Sex: F
Vaccine: FLUX, HEP, FLU3, HEP
Symptoms: Chills, Cough, Night sweats, Pain, Pain in extremity
Clinical narrative: Within 12 hours of receiving Hepatitis B and 2009 seasonal Flu vaccine, patient experienced generalized aches and pains, leg aches, chills, night sweats, coughing to the point of vomitting. All symptoms lasted about 12 hours according to this patient.
Age: 22.0
Sex: F
Vaccine: FLUX, HEP, FLU3, HEP
Symptoms: Vomiting
Clinical narrative: Within 12 hours of receiving Hepatitis B and 2009 seasonal Flu vaccine, patient experienced generalized aches and pains, leg aches, chills, night sweats, coughing to the point of vomitting. All symptoms lasted about 12 hours according to this patient.
Age: 31.0
Sex: M
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Dehydration, Guillain-Barre syndrome, Viral infection
Clinical narrative: 31 year old male admitted to the Medical Center for rehabilitation post Guillain Barre.  He presented 3 weeks before admission (10/29/09) to Hospital with acute upper and lower extremity weakness associated with diplopia. He was diagnosed with Guillain Barre and treated with IVIG for 5 days. After 35 days in the hospital, the patient was discharged under stable condition.
Age: 31.0
Sex: M
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Alanine aminotransferase increased, Anxiety, Aspartate aminotransferase increased, Blood product transfusion, Burning sensation
Clinical narrative: 31 year old male admitted to the Medical Center for rehabilitation post Guillain Barre.  He presented 3 weeks before admission (10/29/09) to Hospital with acute upper and lower extremity weakness associated with diplopia. He was diagnosed with Guillain Barre and treated with IVIG for 5 days. After 35 days in the hospital, the patient was discharged under stable condition.
Age: 31.0
Sex: M
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Communication disorder, Condition aggravated, Conversion disorder, Convulsion, Diplopia
Clinical narrative: 31 year old male admitted to the Medical Center for rehabilitation post Guillain Barre.  He presented 3 weeks before admission (10/29/09) to Hospital with acute upper and lower extremity weakness associated with diplopia. He was diagnosed with Guillain Barre and treated with IVIG for 5 days. After 35 days in the hospital, the patient was discharged under stable condition.
Age: 31.0
Sex: M
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Dyskinesia, Dyspnoea, Extensor plantar response, Feeling abnormal, Gaze palsy
Clinical narrative: 31 year old male admitted to the Medical Center for rehabilitation post Guillain Barre.  He presented 3 weeks before admission (10/29/09) to Hospital with acute upper and lower extremity weakness associated with diplopia. He was diagnosed with Guillain Barre and treated with IVIG for 5 days. After 35 days in the hospital, the patient was discharged under stable condition.
Age: 31.0
Sex: M
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Guillain-Barre syndrome, Hemicephalalgia, Hypoaesthesia facial, Laboratory test normal, Muscular weakness
Clinical narrative: 31 year old male admitted to the Medical Center for rehabilitation post Guillain Barre.  He presented 3 weeks before admission (10/29/09) to Hospital with acute upper and lower extremity weakness associated with diplopia. He was diagnosed with Guillain Barre and treated with IVIG for 5 days. After 35 days in the hospital, the patient was discharged under stable condition.
Age: 31.0
Sex: M
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Nuclear magnetic resonance imaging normal, Opisthotonus, Pain in extremity, Scan brain, Stress
Clinical narrative: 31 year old male admitted to the Medical Center for rehabilitation post Guillain Barre.  He presented 3 weeks before admission (10/29/09) to Hospital with acute upper and lower extremity weakness associated with diplopia. He was diagnosed with Guillain Barre and treated with IVIG for 5 days. After 35 days in the hospital, the patient was discharged under stable condition.
Age: 31.0
Sex: M
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Blood product transfusion, Diplopia, Guillain-Barre syndrome, Muscular weakness
Clinical narrative: 31 year old male admitted to the Medical Center for rehabilitation post Guillain Barre.  He presented 3 weeks before admission (10/29/09) to Hospital with acute upper and lower extremity weakness associated with diplopia. He was diagnosed with Guillain Barre and treated with IVIG for 5 days. After 35 days in the hospital, the patient was discharged under stable condition.
Age: 48.0
Sex: F
Vaccine: FLU3, HEP, FLU3, HEP
Symptoms: Bone pain, Pain in extremity, Product quality issue, Similar reaction on previous exposure to drug
Clinical narrative: Complained of bilateral leg muscles-aches and "bone pain" complained of sluggish walking flu-like her legs "dragged" the following am. On her own, used OTC anti-inflammatory and pain products which were effective. Called her PMD but was not seen by PMD. On 11/16 stated the discomfort was also in her arms. I advised her to see ER MD-she stated on phone she would.
Age: 48.0
Sex: F
Vaccine: FLU3, HEP, FLU3, HEP
Symptoms: Bone pain, Influenza like illness, Limb discomfort, Myalgia, Sluggishness
Clinical narrative: Complained of bilateral leg muscles-aches and "bone pain" complained of sluggish walking flu-like her legs "dragged" the following am. On her own, used OTC anti-inflammatory and pain products which were effective. Called her PMD but was not seen by PMD. On 11/16 stated the discomfort was also in her arms. I advised her to see ER MD-she stated on phone she would.
Age: 61.0
Sex: M
Vaccine: FLU3, HEP, FLU3, HEP, FLU3, HEP
Symptoms: Arthralgia, Bone pain, Gait disturbance, Pain in extremity, Product quality issue
Clinical narrative: Started evening of vaccination he began to have leg ache then legs started swelling and next day legs were "dragging". States had similar but very mild symptoms after 1st HEP B 5 weeks ago. Progressive weakness in lower limbs at 30 hrs; advised to see primary MD - he did. Was given INDOCIN by MD. Rested at home next few days. 11/20/09. Tel f/u - states he's "fine", no mobility issues.
Age: 61.0
Sex: M
Vaccine: FLU3, HEP, FLU3, HEP, FLU3, HEP
Symptoms: Gait disturbance, Joint swelling, Oedema peripheral
Clinical narrative: Started evening of vaccination he began to have leg ache then legs started swelling and next day legs were "dragging". States had similar but very mild symptoms after 1st HEP B 5 weeks ago. Progressive weakness in lower limbs at 30 hrs; advised to see primary MD - he did. Was given INDOCIN by MD. Rested at home next few days. 11/20/09. Tel f/u - states he's "fine", no mobility issues.
Age: 61.0
Sex: M
Vaccine: FLU3, HEP, FLU3, HEP, FLU3, HEP
Symptoms: Gait disturbance, Muscular weakness, Oedema peripheral, Pain in extremity
Clinical narrative: Started evening of vaccination he began to have leg ache then legs started swelling and next day legs were "dragging". States had similar but very mild symptoms after 1st HEP B 5 weeks ago. Progressive weakness in lower limbs at 30 hrs; advised to see primary MD - he did. Was given INDOCIN by MD. Rested at home next few days. 11/20/09. Tel f/u - states he's "fine", no mobility issues.
Age: 27.0
Sex: F
Vaccine: FLUN(H1N1), FLUN(H1N1)
Symptoms: Drug eruption
Clinical narrative: Rash all over body and in mouth.
Age: 27.0
Sex: F
Vaccine: FLUN(H1N1), FLUN(H1N1)
Symptoms: Rash, Rash generalised
Clinical narrative: Rash all over body and in mouth.
Age: 31.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Abortion spontaneous, Cervix haemorrhage uterine, Drug exposure during pregnancy
Clinical narrative: On November 15, patient had a miscarriage of an 11 weeks old pregnancy.On Nov 18th, she went to Hospital ER due to severe pelvic pain.
Age: 31.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pelvic pain
Clinical narrative: On November 15, patient had a miscarriage of an 11 weeks old pregnancy.On Nov 18th, she went to Hospital ER due to severe pelvic pain.
Age: 54.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Blood culture, Dysphonia, Electrocardiogram, Fatigue, Generalised oedema
Clinical narrative: Total Progression: Redness swollen around injection site. Hive around the injection site; continue to progress and got worst. On Sunday -generalized swollen both ankles. Puffiness, edema, fingers got swollen. No fever-started with aches and pain through out the body and joints, headache, voice go hoarse-low pitch still no fever. On Monday--- pain continued swollen same areas. Could not get up by herself. Hoarseness, headaches, mild upset stomach, no appetite, confusion began and stress started. She is a sudden death heart patient, had full blown stroke in June 2009. Elevation in stroke illness symptoms. Tuesday---screaming, running fever of 104 degrees, vomiting, delirious.
Age: 54.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Injection site swelling, Injection site urticaria, Laboratory test, Lumbar puncture, Myalgia
Clinical narrative: Total Progression: Redness swollen around injection site. Hive around the injection site; continue to progress and got worst. On Sunday -generalized swollen both ankles. Puffiness, edema, fingers got swollen. No fever-started with aches and pain through out the body and joints, headache, voice go hoarse-low pitch still no fever. On Monday--- pain continued swollen same areas. Could not get up by herself. Hoarseness, headaches, mild upset stomach, no appetite, confusion began and stress started. She is a sudden death heart patient, had full blown stroke in June 2009. Elevation in stroke illness symptoms. Tuesday---screaming, running fever of 104 degrees, vomiting, delirious.
Age: 54.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Oedema, Pyrexia, Scan brain, Vomiting
Clinical narrative: Total Progression: Redness swollen around injection site. Hive around the injection site; continue to progress and got worst. On Sunday -generalized swollen both ankles. Puffiness, edema, fingers got swollen. No fever-started with aches and pain through out the body and joints, headache, voice go hoarse-low pitch still no fever. On Monday--- pain continued swollen same areas. Could not get up by herself. Hoarseness, headaches, mild upset stomach, no appetite, confusion began and stress started. She is a sudden death heart patient, had full blown stroke in June 2009. Elevation in stroke illness symptoms. Tuesday---screaming, running fever of 104 degrees, vomiting, delirious.
Age: 54.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Abdominal discomfort, Arthralgia, Blood culture, Computerised tomogram, Condition aggravated
Clinical narrative: Total Progression: Redness swollen around injection site. Hive around the injection site; continue to progress and got worst. On Sunday -generalized swollen both ankles. Puffiness, edema, fingers got swollen. No fever-started with aches and pain through out the body and joints, headache, voice go hoarse-low pitch still no fever. On Monday--- pain continued swollen same areas. Could not get up by herself. Hoarseness, headaches, mild upset stomach, no appetite, confusion began and stress started. She is a sudden death heart patient, had full blown stroke in June 2009. Elevation in stroke illness symptoms. Tuesday---screaming, running fever of 104 degrees, vomiting, delirious.
Age: 54.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Confusional state, Culture, Culture urine, Decreased appetite, Delirium
Clinical narrative: Total Progression: Redness swollen around injection site. Hive around the injection site; continue to progress and got worst. On Sunday -generalized swollen both ankles. Puffiness, edema, fingers got swollen. No fever-started with aches and pain through out the body and joints, headache, voice go hoarse-low pitch still no fever. On Monday--- pain continued swollen same areas. Could not get up by herself. Hoarseness, headaches, mild upset stomach, no appetite, confusion began and stress started. She is a sudden death heart patient, had full blown stroke in June 2009. Elevation in stroke illness symptoms. Tuesday---screaming, running fever of 104 degrees, vomiting, delirious.
Age: 54.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Dysphonia, Dysstasia, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Total Progression: Redness swollen around injection site. Hive around the injection site; continue to progress and got worst. On Sunday -generalized swollen both ankles. Puffiness, edema, fingers got swollen. No fever-started with aches and pain through out the body and joints, headache, voice go hoarse-low pitch still no fever. On Monday--- pain continued swollen same areas. Could not get up by herself. Hoarseness, headaches, mild upset stomach, no appetite, confusion began and stress started. She is a sudden death heart patient, had full blown stroke in June 2009. Elevation in stroke illness symptoms. Tuesday---screaming, running fever of 104 degrees, vomiting, delirious.
Age: 54.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Injection site urticaria, Joint swelling, Oedema, Oedema peripheral, Pain
Clinical narrative: Total Progression: Redness swollen around injection site. Hive around the injection site; continue to progress and got worst. On Sunday -generalized swollen both ankles. Puffiness, edema, fingers got swollen. No fever-started with aches and pain through out the body and joints, headache, voice go hoarse-low pitch still no fever. On Monday--- pain continued swollen same areas. Could not get up by herself. Hoarseness, headaches, mild upset stomach, no appetite, confusion began and stress started. She is a sudden death heart patient, had full blown stroke in June 2009. Elevation in stroke illness symptoms. Tuesday---screaming, running fever of 104 degrees, vomiting, delirious.
Age: 54.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Pyrexia, Saliva analysis, Screaming, Spinal fusion surgery, Stress
Clinical narrative: Total Progression: Redness swollen around injection site. Hive around the injection site; continue to progress and got worst. On Sunday -generalized swollen both ankles. Puffiness, edema, fingers got swollen. No fever-started with aches and pain through out the body and joints, headache, voice go hoarse-low pitch still no fever. On Monday--- pain continued swollen same areas. Could not get up by herself. Hoarseness, headaches, mild upset stomach, no appetite, confusion began and stress started. She is a sudden death heart patient, had full blown stroke in June 2009. Elevation in stroke illness symptoms. Tuesday---screaming, running fever of 104 degrees, vomiting, delirious.
Age: 54.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Urine analysis abnormal, Vomiting
Clinical narrative: Total Progression: Redness swollen around injection site. Hive around the injection site; continue to progress and got worst. On Sunday -generalized swollen both ankles. Puffiness, edema, fingers got swollen. No fever-started with aches and pain through out the body and joints, headache, voice go hoarse-low pitch still no fever. On Monday--- pain continued swollen same areas. Could not get up by herself. Hoarseness, headaches, mild upset stomach, no appetite, confusion began and stress started. She is a sudden death heart patient, had full blown stroke in June 2009. Elevation in stroke illness symptoms. Tuesday---screaming, running fever of 104 degrees, vomiting, delirious.
Age: 3.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Abdominal pain upper, Decreased appetite, Diarrhoea, Discomfort, Fatigue
Clinical narrative: Loose stools, fever approx. 101 degrees, headache, lethargic/very tired, uncomfortable stomach pain.  Loss of appetite.
Age: 3.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Headache, Lethargy, Pyrexia
Clinical narrative: Loose stools, fever approx. 101 degrees, headache, lethargic/very tired, uncomfortable stomach pain.  Loss of appetite.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Death, Loss of consciousness, Resuscitation
Clinical narrative: On August 12, 2009, 11:39 AM, infant had four-month checkup and was found to be well.  At 12:00 PM, he was given five immunizations (DTaP/DT, IPV, Hib, PCV7, Rotovirus).  The following morning at 8:00 AM (20 hours later), he was found unconscious by his parents.  Cardiopulmonary resuscitation was initiated.  Emergency medical services found the infant in full code.  He was transported to the hospital where he was essentially dead on arrival.  12/10/09 Autopsy report received. Cause of Death: Undetermined. Manner of Death: Undetermined. Additional infomation abstracted: Pathological Diagnosis - Well baby by clinical history. Overlay cannot be excluded.   12/3/09 PCP, cardiology consultation, and hospital records received. Service dates 4/1/09 to 8/13/09. Assessment: Not breathing. Child was sleeping with parents, not breathing this AM. EMS called.
Age: 1.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Crying, Injection site erythema
Clinical narrative: Escalating crying post injection. Erythema @ site right thigh. * site of injection medial to desired area.  12/01/09 Pediatric visit notes for DOS 12/01/09.   Parent of Pt c/o crying all day, and pain. On physical examination physician noted erythema at the site of injection, R thigh.  All other systems were negative upon examination. Tx: Tylenol. Pt was consolable when crying. Pt scheduled for a follow up visit in 2 mos.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event, Wrong drug administered
Clinical narrative: 12/01/09 @ 7:05pm: I administered Tdap (ADACEL) to pt instead of GARDASIL #2.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Pt given Tdap & she should have received a Tetanus.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Pt given Tdap and she should have received a Tetanus.
Age: 70.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Pt given Tdap and should have received a Tetanus instead.
Age: 15.0
Sex: M
Vaccine: HEPAB, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None TWINRIX vaccine for persons 18 years of age or older.
Age: 6.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Pruritus, Urticaria
Clinical narrative: broke out in hives back arms chest real itchy
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Rash, skin eruptions, itching.  Random locations - legs, buttocks, upper back and neck, upper neck into hairline, chest, belly, arms
Age: 56.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dysarthria, Hypoaesthesia oral, Throat tightness
Clinical narrative: About 10 minutes after administering the H1N1 vaccination, the patient develop perioral numbness, throat tightness and dysarthria. Epinephrine 1:1000 0.1mL was given IM, the patient was monitored and medrol dose pack was prescribed.
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Injection site pain, Mobility decreased, Pain, Swelling
Clinical narrative: Rt arm sore at injection site. Redness, swelling, difficulty in movement, pain and tenderness.
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Tenderness
Clinical narrative: Rt arm sore at injection site. Redness, swelling, difficulty in movement, pain and tenderness.
Age: 43.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Full blood count, Red blood cell sedimentation rate, Urticaria
Clinical narrative: PATIENT REFERS THE DEVELOPMENT OF HIVES (ALLERGY-LIKE) IN TRUNK AND ARMS 48 HOURS AFTER VACCINATION. WAS TREATED WITH CLARINEX 5MG AND ORAL STEROIDS.
Age: 7.0
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Culture, Herpes zoster
Clinical narrative: Patient developed a clinical syndrome for shingles on Oct 20, 2009. A viral culture was negative for HSV or Varicella Zoster. The lab reports this test would not pick up vaccine related virus.
Age: 43.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Feeling of body temperature change
Clinical narrative: Hot and Cold feeling for 10 hours post vaccination
Age: 11.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Fatigue, Laryngitis, Lethargy, Malaise, Oropharyngeal pain
Clinical narrative: Woke up saying she did not feel well.   Lethargy all day, sore throat, felt warm.  Next day aches and pains, low fever (100.4) and more lethargy.  This continued through Sunday.  Monday went to school but was tired and complained of sore throat.  Tuesday sore throat turned to laryngitis.  Wednesday we are going to the pediatrician.
Age: 11.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Pain, Pyrexia, Skin warm, Streptococcal identification test
Clinical narrative: Woke up saying she did not feel well.   Lethargy all day, sore throat, felt warm.  Next day aches and pains, low fever (100.4) and more lethargy.  This continued through Sunday.  Monday went to school but was tired and complained of sore throat.  Tuesday sore throat turned to laryngitis.  Wednesday we are going to the pediatrician.
Age: 50.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Burning sensation, Chest pain, Dysphonia, Dyspnoea, Flushing
Clinical narrative: Shortness of breath, muscle weakness, fast heartbeat, chest pain, itching, flush, body feeling like sunburned, hoarseness, headaches Treatment - Benadryl every 4 hours - set alarm to take wake and take medication during night time hours.
Age: 50.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Headache, Heart rate increased, Muscular weakness, Pruritus, Sensory disturbance
Clinical narrative: Shortness of breath, muscle weakness, fast heartbeat, chest pain, itching, flush, body feeling like sunburned, hoarseness, headaches Treatment - Benadryl every 4 hours - set alarm to take wake and take medication during night time hours.
Age: 52.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Dyspnoea, Headache, Hyperhidrosis, Musculoskeletal stiffness
Clinical narrative: c/o headache, slight neck stiffness, moderate diaphoresis, difficult breathing (reported, not observed). .3ml 1:1000 Epinephrine given. Refused transport to hosp @ 2:00pm, walked out, no distress noted.
Age: 52.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Facial palsy
Clinical narrative: Bell's palsy Lt. Tx with Prednisone in decreased dosage. 12/3 and 12/9/2009 ED records for 12/1/2009, patient with c/o's lt facial droop, lt facial tingling, unable to close lt eye, limited lt eyebrow movement and slurred speech. Rx'd prednisone, Dc Dx: Bell's Palsy
Age: 31.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Abortion induced, Drug exposure during pregnancy, Intra-uterine death, Pathology test, Ultrasound scan abnormal
Clinical narrative: PATIENT REFERS THAT ON 11/25/2009 WENT TO THE ER BECAUSE SHE HAD A VAGINAL BLEEDING (SHE WAS 11 WEEK PREGNANT). HAD A SONOGRAM AND IT WAS REVEALED THAT THE BABY WAS DEAD FOR APROXIMATELY 1 WEEK AND A HALF. SHE WAS HOSPITALIZED, HAD TO DELIVER THE DEAD BABY AND A ENDOMETRIAL SCRAPING  WAS PERFORMED. THE FETUS WAS SENT TO PATHOLOGY TO DETERMINE REASON FOR DEATH. RESULTS FROM PATHOLOGY ARE PENDING.  12/02/09 Medical records received for DOS 11/27/09 Final DX: Incomplete abortion. Vaginal bleeding. Cervix open.   G3P2.  LMP 9/10/09.   12/28/2009 prenatal labs and OB-GYN records received.
Age: 31.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Uterine dilation and curettage, Vaginal haemorrhage
Clinical narrative: PATIENT REFERS THAT ON 11/25/2009 WENT TO THE ER BECAUSE SHE HAD A VAGINAL BLEEDING (SHE WAS 11 WEEK PREGNANT). HAD A SONOGRAM AND IT WAS REVEALED THAT THE BABY WAS DEAD FOR APROXIMATELY 1 WEEK AND A HALF. SHE WAS HOSPITALIZED, HAD TO DELIVER THE DEAD BABY AND A ENDOMETRIAL SCRAPING  WAS PERFORMED. THE FETUS WAS SENT TO PATHOLOGY TO DETERMINE REASON FOR DEATH. RESULTS FROM PATHOLOGY ARE PENDING.  12/02/09 Medical records received for DOS 11/27/09 Final DX: Incomplete abortion. Vaginal bleeding. Cervix open.   G3P2.  LMP 9/10/09.   12/28/2009 prenatal labs and OB-GYN records received.