chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Chromosome analysis normal, Complement factor normal, Coombs test positive, Cough, Cytomegalovirus serology
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 15 year old female with anaemia, menstruation irregular with heavy flow and a history of treating with growth hormone from age 10-13 on 17-MAR-2008 was vaccinated with the third dose of GARDASIL IM (therapy dose, site unknown) (Lot# 660387/1967U). Concomitant therapy included the second dose of HAVRIX (therapy dose, route and site unknown) (Lot# AHAVB1244) and oral hormonal contraceptives (unspecified). On 31-OCT-2008 the patient experienced anaemia, anaemia haemolytic autoimmune, arthralgia, blood product transfusion, cough, EVANS syndrome, fatigue, haemoglobin decreased, idiopathic thrombocytopenic purpura, iron deficiency, joint swelling, malaise, microcytic anaemia, oropharyngeal pain, platelet count decreased, pyrexia and thrombocytopenia and was hospitalized. These events were considered to be immediately life-threatening. Coombs test was positive (warm Ab) and haemoglobin=6, platelet=20,000. All tests were negative and comprehensive including bone marrow aspirate and BM biopsy, ANA, reticulocyte count, LDH (Lactate dehydrogenase), complements, chest x ray, serologies for Parvo, CMV, HIV, MONO, iron studies and chromosome analysis. Cause was still unknown. The patient was treated with transfusions, IVIG (intravenous immune globulin), steroids and "wait and see" approach. Ultimately the patient was given RITUXAN. The patient was recently on "remission". On 29-SEP-2009 medical records and diagnoses summary received from date of service 01-NOV-2008 to 07-NOV-2008. The diagnosis was EVANS Syndrome, presented with malaise for one month, fatigue, fever, sore throat, joint pain/swelling, cough, night sweats, anemia, thrombocytopenia, Insidious onset of symptomatic microcytic hypochromic hyperproliferative anemia with evidence of iron deficiency. The treatment was IVIG. The original reporting source was not provided. The VAERS ID # is 356835. A standard lot check investigation was performed. All in-process quality checks for lot number 1967U 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: 15.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Cytomegalovirus test negative, Evans syndrome, Fatigue, HIV test negative, Haemoglobin decreased
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 15 year old female with anaemia, menstruation irregular with heavy flow and a history of treating with growth hormone from age 10-13 on 17-MAR-2008 was vaccinated with the third dose of GARDASIL IM (therapy dose, site unknown) (Lot# 660387/1967U). Concomitant therapy included the second dose of HAVRIX (therapy dose, route and site unknown) (Lot# AHAVB1244) and oral hormonal contraceptives (unspecified). On 31-OCT-2008 the patient experienced anaemia, anaemia haemolytic autoimmune, arthralgia, blood product transfusion, cough, EVANS syndrome, fatigue, haemoglobin decreased, idiopathic thrombocytopenic purpura, iron deficiency, joint swelling, malaise, microcytic anaemia, oropharyngeal pain, platelet count decreased, pyrexia and thrombocytopenia and was hospitalized. These events were considered to be immediately life-threatening. Coombs test was positive (warm Ab) and haemoglobin=6, platelet=20,000. All tests were negative and comprehensive including bone marrow aspirate and BM biopsy, ANA, reticulocyte count, LDH (Lactate dehydrogenase), complements, chest x ray, serologies for Parvo, CMV, HIV, MONO, iron studies and chromosome analysis. Cause was still unknown. The patient was treated with transfusions, IVIG (intravenous immune globulin), steroids and "wait and see" approach. Ultimately the patient was given RITUXAN. The patient was recently on "remission". On 29-SEP-2009 medical records and diagnoses summary received from date of service 01-NOV-2008 to 07-NOV-2008. The diagnosis was EVANS Syndrome, presented with malaise for one month, fatigue, fever, sore throat, joint pain/swelling, cough, night sweats, anemia, thrombocytopenia, Insidious onset of symptomatic microcytic hypochromic hyperproliferative anemia with evidence of iron deficiency. The treatment was IVIG. The original reporting source was not provided. The VAERS ID # is 356835. A standard lot check investigation was performed. All in-process quality checks for lot number 1967U 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: 15.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Idiopathic thrombocytopenic purpura, Iron deficiency, Joint swelling, Laboratory test abnormal, Malaise
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 15 year old female with anaemia, menstruation irregular with heavy flow and a history of treating with growth hormone from age 10-13 on 17-MAR-2008 was vaccinated with the third dose of GARDASIL IM (therapy dose, site unknown) (Lot# 660387/1967U). Concomitant therapy included the second dose of HAVRIX (therapy dose, route and site unknown) (Lot# AHAVB1244) and oral hormonal contraceptives (unspecified). On 31-OCT-2008 the patient experienced anaemia, anaemia haemolytic autoimmune, arthralgia, blood product transfusion, cough, EVANS syndrome, fatigue, haemoglobin decreased, idiopathic thrombocytopenic purpura, iron deficiency, joint swelling, malaise, microcytic anaemia, oropharyngeal pain, platelet count decreased, pyrexia and thrombocytopenia and was hospitalized. These events were considered to be immediately life-threatening. Coombs test was positive (warm Ab) and haemoglobin=6, platelet=20,000. All tests were negative and comprehensive including bone marrow aspirate and BM biopsy, ANA, reticulocyte count, LDH (Lactate dehydrogenase), complements, chest x ray, serologies for Parvo, CMV, HIV, MONO, iron studies and chromosome analysis. Cause was still unknown. The patient was treated with transfusions, IVIG (intravenous immune globulin), steroids and "wait and see" approach. Ultimately the patient was given RITUXAN. The patient was recently on "remission". On 29-SEP-2009 medical records and diagnoses summary received from date of service 01-NOV-2008 to 07-NOV-2008. The diagnosis was EVANS Syndrome, presented with malaise for one month, fatigue, fever, sore throat, joint pain/swelling, cough, night sweats, anemia, thrombocytopenia, Insidious onset of symptomatic microcytic hypochromic hyperproliferative anemia with evidence of iron deficiency. The treatment was IVIG. The original reporting source was not provided. The VAERS ID # is 356835. A standard lot check investigation was performed. All in-process quality checks for lot number 1967U 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: 15.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Microcytic anaemia, Mononucleosis heterophile test negative, Night sweats, Oropharyngeal pain, Parvovirus B19 serology negative
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 15 year old female with anaemia, menstruation irregular with heavy flow and a history of treating with growth hormone from age 10-13 on 17-MAR-2008 was vaccinated with the third dose of GARDASIL IM (therapy dose, site unknown) (Lot# 660387/1967U). Concomitant therapy included the second dose of HAVRIX (therapy dose, route and site unknown) (Lot# AHAVB1244) and oral hormonal contraceptives (unspecified). On 31-OCT-2008 the patient experienced anaemia, anaemia haemolytic autoimmune, arthralgia, blood product transfusion, cough, EVANS syndrome, fatigue, haemoglobin decreased, idiopathic thrombocytopenic purpura, iron deficiency, joint swelling, malaise, microcytic anaemia, oropharyngeal pain, platelet count decreased, pyrexia and thrombocytopenia and was hospitalized. These events were considered to be immediately life-threatening. Coombs test was positive (warm Ab) and haemoglobin=6, platelet=20,000. All tests were negative and comprehensive including bone marrow aspirate and BM biopsy, ANA, reticulocyte count, LDH (Lactate dehydrogenase), complements, chest x ray, serologies for Parvo, CMV, HIV, MONO, iron studies and chromosome analysis. Cause was still unknown. The patient was treated with transfusions, IVIG (intravenous immune globulin), steroids and "wait and see" approach. Ultimately the patient was given RITUXAN. The patient was recently on "remission". On 29-SEP-2009 medical records and diagnoses summary received from date of service 01-NOV-2008 to 07-NOV-2008. The diagnosis was EVANS Syndrome, presented with malaise for one month, fatigue, fever, sore throat, joint pain/swelling, cough, night sweats, anemia, thrombocytopenia, Insidious onset of symptomatic microcytic hypochromic hyperproliferative anemia with evidence of iron deficiency. The treatment was IVIG. The original reporting source was not provided. The VAERS ID # is 356835. A standard lot check investigation was performed. All in-process quality checks for lot number 1967U 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: 15.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Platelet count decreased, Pyrexia, Reticulocyte count normal, Thrombocytopenia
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 15 year old female with anaemia, menstruation irregular with heavy flow and a history of treating with growth hormone from age 10-13 on 17-MAR-2008 was vaccinated with the third dose of GARDASIL IM (therapy dose, site unknown) (Lot# 660387/1967U). Concomitant therapy included the second dose of HAVRIX (therapy dose, route and site unknown) (Lot# AHAVB1244) and oral hormonal contraceptives (unspecified). On 31-OCT-2008 the patient experienced anaemia, anaemia haemolytic autoimmune, arthralgia, blood product transfusion, cough, EVANS syndrome, fatigue, haemoglobin decreased, idiopathic thrombocytopenic purpura, iron deficiency, joint swelling, malaise, microcytic anaemia, oropharyngeal pain, platelet count decreased, pyrexia and thrombocytopenia and was hospitalized. These events were considered to be immediately life-threatening. Coombs test was positive (warm Ab) and haemoglobin=6, platelet=20,000. All tests were negative and comprehensive including bone marrow aspirate and BM biopsy, ANA, reticulocyte count, LDH (Lactate dehydrogenase), complements, chest x ray, serologies for Parvo, CMV, HIV, MONO, iron studies and chromosome analysis. Cause was still unknown. The patient was treated with transfusions, IVIG (intravenous immune globulin), steroids and "wait and see" approach. Ultimately the patient was given RITUXAN. The patient was recently on "remission". On 29-SEP-2009 medical records and diagnoses summary received from date of service 01-NOV-2008 to 07-NOV-2008. The diagnosis was EVANS Syndrome, presented with malaise for one month, fatigue, fever, sore throat, joint pain/swelling, cough, night sweats, anemia, thrombocytopenia, Insidious onset of symptomatic microcytic hypochromic hyperproliferative anemia with evidence of iron deficiency. The treatment was IVIG. The original reporting source was not provided. The VAERS ID # is 356835. A standard lot check investigation was performed. All in-process quality checks for lot number 1967U 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: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Electroencephalogram abnormal, Epilepsy, Muscle twitching, Myoclonic epilepsy
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 16 year old female with a history of dislocated shoulder, irregular periods, migraine and appendicectomy who on 17-MAR-2008 was vaccinated in right arm with the first dose of GARDASIL (LOT# 659653/1448U). On 19-MAY-2008 the patient was vaccinated with the second dose of GARDASIL. The patient did not have the third dose of GARDASIL. On an unknown date, the patient stated she had twitching spells after awakening. The reporter thought that it was just might be the way the patient was sleeping because it did not happen everyday. On 15-AUG-2008 the patient had a major seizure and was admitted to the hospital. She was diagnosed with epilepsy. She had 5 major seizures since and saw a neurologist on a regular basis. The patient was diagnosed with Juvenile myoclonic epilepsy. She took LAMICTAL 300 mg twice daily. The patient had regular electroencephalography (EEG). There was no history on either side of the family of a seizure disorder and she had never had any seizure history and no major illnesses. Neurologist commented that this might affect her for the rest of her life. Since 15-AUG-2008 the patient was tested on regular basis. EEGs showed abnormal which were consistent with seizure disorder. EEGs were done in 5 or 6 times and only the last 2 had shown normal with medication. The result of Computed axial tomography brain was negative. White blood cell count was 18 and blood sugar was 119. Shoulder x-ray had a positive result of dislocation and compression. On 29-SEP-2009 medical record was received for date of service on 15-Aug-2008 and 16-Aug-2008 with discharge diagnosis of seizure activity, right shoulder dislocation and syncope. Patient presented after witnessed seizure activity. She found passed out in bathtub. Patient dislocated/fractured her shoulder during the episode. It was also reported pre-syncopal episodes for 6 months. On 02-OCT-2009 neurology consult records were received for date of service on 14-SEP-2009. An assessment for Juvenile myoclonic epilepsy was done. Seizures occurred upon awakening and initial myoclonic jerks was reported. Compression fracture, epilepsy, joint dislocation, loss of consciousness, muscle twitching, myoclonic epilepsy, myoclonus, presyncope, syncope and convulsion were considered to be disabling and to be immediately life-threatening. The patient required an emergency room visit. The original reporting source was not provided. The VAERS ID # is 357365. 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. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Epilepsy, Joint dislocation, Loss of consciousness, Muscle twitching, Myoclonic epilepsy
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 16 year old female with a history of dislocated shoulder, irregular periods, migraine and appendicectomy who on 17-MAR-2008 was vaccinated in right arm with the first dose of GARDASIL (LOT# 659653/1448U). On 19-MAY-2008 the patient was vaccinated with the second dose of GARDASIL. The patient did not have the third dose of GARDASIL. On an unknown date, the patient stated she had twitching spells after awakening. The reporter thought that it was just might be the way the patient was sleeping because it did not happen everyday. On 15-AUG-2008 the patient had a major seizure and was admitted to the hospital. She was diagnosed with epilepsy. She had 5 major seizures since and saw a neurologist on a regular basis. The patient was diagnosed with Juvenile myoclonic epilepsy. She took LAMICTAL 300 mg twice daily. The patient had regular electroencephalography (EEG). There was no history on either side of the family of a seizure disorder and she had never had any seizure history and no major illnesses. Neurologist commented that this might affect her for the rest of her life. Since 15-AUG-2008 the patient was tested on regular basis. EEGs showed abnormal which were consistent with seizure disorder. EEGs were done in 5 or 6 times and only the last 2 had shown normal with medication. The result of Computed axial tomography brain was negative. White blood cell count was 18 and blood sugar was 119. Shoulder x-ray had a positive result of dislocation and compression. On 29-SEP-2009 medical record was received for date of service on 15-Aug-2008 and 16-Aug-2008 with discharge diagnosis of seizure activity, right shoulder dislocation and syncope. Patient presented after witnessed seizure activity. She found passed out in bathtub. Patient dislocated/fractured her shoulder during the episode. It was also reported pre-syncopal episodes for 6 months. On 02-OCT-2009 neurology consult records were received for date of service on 14-SEP-2009. An assessment for Juvenile myoclonic epilepsy was done. Seizures occurred upon awakening and initial myoclonic jerks was reported. Compression fracture, epilepsy, joint dislocation, loss of consciousness, muscle twitching, myoclonic epilepsy, myoclonus, presyncope, syncope and convulsion were considered to be disabling and to be immediately life-threatening. The patient required an emergency room visit. The original reporting source was not provided. The VAERS ID # is 357365. 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. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Myoclonus, Presyncope, Syncope, Upper limb fracture, White blood cell count increased
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 16 year old female with a history of dislocated shoulder, irregular periods, migraine and appendicectomy who on 17-MAR-2008 was vaccinated in right arm with the first dose of GARDASIL (LOT# 659653/1448U). On 19-MAY-2008 the patient was vaccinated with the second dose of GARDASIL. The patient did not have the third dose of GARDASIL. On an unknown date, the patient stated she had twitching spells after awakening. The reporter thought that it was just might be the way the patient was sleeping because it did not happen everyday. On 15-AUG-2008 the patient had a major seizure and was admitted to the hospital. She was diagnosed with epilepsy. She had 5 major seizures since and saw a neurologist on a regular basis. The patient was diagnosed with Juvenile myoclonic epilepsy. She took LAMICTAL 300 mg twice daily. The patient had regular electroencephalography (EEG). There was no history on either side of the family of a seizure disorder and she had never had any seizure history and no major illnesses. Neurologist commented that this might affect her for the rest of her life. Since 15-AUG-2008 the patient was tested on regular basis. EEGs showed abnormal which were consistent with seizure disorder. EEGs were done in 5 or 6 times and only the last 2 had shown normal with medication. The result of Computed axial tomography brain was negative. White blood cell count was 18 and blood sugar was 119. Shoulder x-ray had a positive result of dislocation and compression. On 29-SEP-2009 medical record was received for date of service on 15-Aug-2008 and 16-Aug-2008 with discharge diagnosis of seizure activity, right shoulder dislocation and syncope. Patient presented after witnessed seizure activity. She found passed out in bathtub. Patient dislocated/fractured her shoulder during the episode. It was also reported pre-syncopal episodes for 6 months. On 02-OCT-2009 neurology consult records were received for date of service on 14-SEP-2009. An assessment for Juvenile myoclonic epilepsy was done. Seizures occurred upon awakening and initial myoclonic jerks was reported. Compression fracture, epilepsy, joint dislocation, loss of consciousness, muscle twitching, myoclonic epilepsy, myoclonus, presyncope, syncope and convulsion were considered to be disabling and to be immediately life-threatening. The patient required an emergency room visit. The original reporting source was not provided. The VAERS ID # is 357365. 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. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: X-ray limb 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 16 year old female with a history of dislocated shoulder, irregular periods, migraine and appendicectomy who on 17-MAR-2008 was vaccinated in right arm with the first dose of GARDASIL (LOT# 659653/1448U). On 19-MAY-2008 the patient was vaccinated with the second dose of GARDASIL. The patient did not have the third dose of GARDASIL. On an unknown date, the patient stated she had twitching spells after awakening. The reporter thought that it was just might be the way the patient was sleeping because it did not happen everyday. On 15-AUG-2008 the patient had a major seizure and was admitted to the hospital. She was diagnosed with epilepsy. She had 5 major seizures since and saw a neurologist on a regular basis. The patient was diagnosed with Juvenile myoclonic epilepsy. She took LAMICTAL 300 mg twice daily. The patient had regular electroencephalography (EEG). There was no history on either side of the family of a seizure disorder and she had never had any seizure history and no major illnesses. Neurologist commented that this might affect her for the rest of her life. Since 15-AUG-2008 the patient was tested on regular basis. EEGs showed abnormal which were consistent with seizure disorder. EEGs were done in 5 or 6 times and only the last 2 had shown normal with medication. The result of Computed axial tomography brain was negative. White blood cell count was 18 and blood sugar was 119. Shoulder x-ray had a positive result of dislocation and compression. On 29-SEP-2009 medical record was received for date of service on 15-Aug-2008 and 16-Aug-2008 with discharge diagnosis of seizure activity, right shoulder dislocation and syncope. Patient presented after witnessed seizure activity. She found passed out in bathtub. Patient dislocated/fractured her shoulder during the episode. It was also reported pre-syncopal episodes for 6 months. On 02-OCT-2009 neurology consult records were received for date of service on 14-SEP-2009. An assessment for Juvenile myoclonic epilepsy was done. Seizures occurred upon awakening and initial myoclonic jerks was reported. Compression fracture, epilepsy, joint dislocation, loss of consciousness, muscle twitching, myoclonic epilepsy, myoclonus, presyncope, syncope and convulsion were considered to be disabling and to be immediately life-threatening. The patient required an emergency room visit. The original reporting source was not provided. The VAERS ID # is 357365. 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. No further information is available.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cough, Dizziness, Dysphonia, Injection site erythema, Injection site pain
Clinical narrative: 11:45 pt returned to clinic room approximately 1 hr after receiving flu shot. Complaining of "scratchy" throat, feeling itchy, and coughing. Vaccination shot red and very swollen. Vital signs: B/: 180/90; Resp 14; pulse 84. .3 ml Epinephrine 1:1000 administered at 11:50. 911 called and arrived approx 12:05. Pt c/o feeling shaky, but throat better, no coughing, and feeling less itchy. Transported to ER.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Oedema peripheral, Pallor
Clinical narrative: 11:45 pt returned to clinic room approximately 1 hr after receiving flu shot. Complaining of "scratchy" throat, feeling itchy, and coughing. Vaccination shot red and very swollen. Vital signs: B/: 180/90; Resp 14; pulse 84. .3 ml Epinephrine 1:1000 administered at 11:50. 911 called and arrived approx 12:05. Pt c/o feeling shaky, but throat better, no coughing, and feeling less itchy. Transported to ER.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Palpitations, Pharyngeal oedema, Pruritus, Pyrexia, Urticaria
Clinical narrative: 11:45 pt returned to clinic room approximately 1 hr after receiving flu shot. Complaining of "scratchy" throat, feeling itchy, and coughing. Vaccination shot red and very swollen. Vital signs: B/: 180/90; Resp 14; pulse 84. .3 ml Epinephrine 1:1000 administered at 11:50. 911 called and arrived approx 12:05. Pt c/o feeling shaky, but throat better, no coughing, and feeling less itchy. Transported to ER.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cough, Injection site erythema, Injection site swelling, Pruritus, Throat irritation
Clinical narrative: 11:45 pt returned to clinic room approximately 1 hr after receiving flu shot. Complaining of "scratchy" throat, feeling itchy, and coughing. Vaccination shot red and very swollen. Vital signs: B/: 180/90; Resp 14; pulse 84. .3 ml Epinephrine 1:1000 administered at 11:50. 911 called and arrived approx 12:05. Pt c/o feeling shaky, but throat better, no coughing, and feeling less itchy. Transported to ER.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Tremor
Clinical narrative: 11:45 pt returned to clinic room approximately 1 hr after receiving flu shot. Complaining of "scratchy" throat, feeling itchy, and coughing. Vaccination shot red and very swollen. Vital signs: B/: 180/90; Resp 14; pulse 84. .3 ml Epinephrine 1:1000 administered at 11:50. 911 called and arrived approx 12:05. Pt c/o feeling shaky, but throat better, no coughing, and feeling less itchy. Transported to ER.
Age: 71.0
Sex: U
Vaccine: PPV, FLU3
Symptoms: Asthenia, Dyspnoea, Electrocardiogram, Mobility decreased, Pain in extremity
Clinical narrative: Ok at first, then my arm felt like it was going to fall off. I started breathing hard, real hard. My heart started pounding and hurting got sick. 12/03/09 Medical records received fro DOS 8/11/08. Final Adverse event of vaccines, L shoulder swelling/deltoid swelling and pain, costochondritis (Teitze's Syndrome) Aching in arm s/p vaccine. Mild swelling. Tenderness. Shoulder pain. Intense pain. Spread to chest and neck. Hard breathing and palpitations. Resolved.  Later c/o stiff neck x1 month, sciatica and back issues.  ICD9 codes: 729.81, E949.9, 733.6
Age: 71.0
Sex: U
Vaccine: PPV, FLU3
Symptoms: Palpitations
Clinical narrative: Ok at first, then my arm felt like it was going to fall off. I started breathing hard, real hard. My heart started pounding and hurting got sick. 12/03/09 Medical records received fro DOS 8/11/08. Final Adverse event of vaccines, L shoulder swelling/deltoid swelling and pain, costochondritis (Teitze's Syndrome) Aching in arm s/p vaccine. Mild swelling. Tenderness. Shoulder pain. Intense pain. Spread to chest and neck. Hard breathing and palpitations. Resolved.  Later c/o stiff neck x1 month, sciatica and back issues.  ICD9 codes: 729.81, E949.9, 733.6
Age: 71.0
Sex: U
Vaccine: PPV, FLU3
Symptoms: Chest pain, Dyspnoea, Limb discomfort, Malaise, Palpitations
Clinical narrative: Ok at first, then my arm felt like it was going to fall off. I started breathing hard, real hard. My heart started pounding and hurting got sick. 12/03/09 Medical records received fro DOS 8/11/08. Final Adverse event of vaccines, L shoulder swelling/deltoid swelling and pain, costochondritis (Teitze's Syndrome) Aching in arm s/p vaccine. Mild swelling. Tenderness. Shoulder pain. Intense pain. Spread to chest and neck. Hard breathing and palpitations. Resolved.  Later c/o stiff neck x1 month, sciatica and back issues.  ICD9 codes: 729.81, E949.9, 733.6
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site abscess, Injection site erythema, Injection site swelling, Ultrasound scan
Clinical narrative: Initial and follow-up reports were received on 19 November 2009 from a health care professional. A male patient who had no concurrent illnesses and no known allergies, had received at age 6 months a dose of ACTHIB (lot number D0049-1, Sanofi pasteur lot number UF569AB), PEDIARIX (manufacturer GlaxoSmithKline, lot number AC21B210AA) and PREVNAR (manufacturer Wyeth, lot number D49997). The routes and sites of administration were not reported for any of the vaccines. At an unspecified amount of time later, the patient experienced mild local reactions at each vaccination site and then developed a sterile abscesses at each site. The abscesses grew in size and were tender and painful and needed to be surgically removed. With other unspecified vaccinations at 2 and 4 months of age, the patient only experienced mild local reactions at the injection sites. At the time of this report, it was "unknown" if the patient had recovered. Documents held by sender: None.
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site abscess sterile, Injection site pain, Local reaction, Surgery
Clinical narrative: Initial and follow-up reports were received on 19 November 2009 from a health care professional. A male patient who had no concurrent illnesses and no known allergies, had received at age 6 months a dose of ACTHIB (lot number D0049-1, Sanofi pasteur lot number UF569AB), PEDIARIX (manufacturer GlaxoSmithKline, lot number AC21B210AA) and PREVNAR (manufacturer Wyeth, lot number D49997). The routes and sites of administration were not reported for any of the vaccines. At an unspecified amount of time later, the patient experienced mild local reactions at each vaccination site and then developed a sterile abscesses at each site. The abscesses grew in size and were tender and painful and needed to be surgically removed. With other unspecified vaccinations at 2 and 4 months of age, the patient only experienced mild local reactions at the injection sites. At the time of this report, it was "unknown" if the patient had recovered. Documents held by sender: None.
Age: 1.42
Sex: M
Vaccine: FLU(H1N1), FLUX(H1N1)
Symptoms: Erythema, Pruritus, Skin disorder, Urticaria
Clinical narrative: Generalized urticarial rash. Treated with BENADRYL.
Age: 1.42
Sex: M
Vaccine: FLU(H1N1), FLUX(H1N1)
Symptoms: Urticaria
Clinical narrative: Generalized urticarial rash. Treated with BENADRYL.
Age: 31.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site reaction, Pain, Tendonitis
Clinical narrative: Ongoing arm pain at injection site (deltoid), weakness of arm still 7 weeks later, had steroids
Age: 31.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Drug exposure during pregnancy, Injection site pain, Muscular weakness
Clinical narrative: Ongoing arm pain at injection site (deltoid), weakness of arm still 7 weeks later, had steroids
Age: 4.0
Sex: M
Vaccine: FLU(H1N1), FLUX(H1N1)
Symptoms: Lip swelling, Swollen tongue, Urticaria, Wheezing
Clinical narrative: Itching, rash, hives, swollen lips.
Age: 4.0
Sex: M
Vaccine: FLU(H1N1), FLUX(H1N1)
Symptoms: Lip swelling, Pruritus, Rash, Urticaria
Clinical narrative: Itching, rash, hives, swollen lips.
Age: 8.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1), FLUN3, FLUX(H1N1)
Symptoms: Abasia, Joint effusion, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Synovitis
Clinical narrative: Patient complained of leg pain 2 days post vaccination. Patient continued leg pain and pain increased to hip, patient was admitted for one day.
Age: 8.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1), FLUN3, FLUX(H1N1)
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Patient complained of leg pain 2 days post vaccination. Patient continued leg pain and pain increased to hip, patient was admitted for one day.
Age: 8.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1), FLUN3, FLUX(H1N1)
Symptoms: Arthralgia, Immobile, Laboratory test, Pain in extremity
Clinical narrative: Patient complained of leg pain 2 days post vaccination. Patient continued leg pain and pain increased to hip, patient was admitted for one day.
Age: 44.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Arthralgia, Chondrocalcinosis pyrophosphate, Joint swelling, Synovitis
Clinical narrative: Sudden onset of left wrist pain,rapidly progressing to severe with associated swelling. (acute synovitis/pseudogout) Same arm as injection
Age: 40.0
Sex: M
Vaccine: FLUN3
Symptoms: Facial palsy, Hypoaesthesia facial, Paraesthesia
Clinical narrative: RIGHT SIDED FACIAL NUMBNESS AND TINGLING (BELL'S PALSY) 62 DAYS FOLLOWING ADMIN OF FLUMIST
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Aggression, Clumsiness, Confusional state, Cough, Drooling
Clinical narrative: Due to allergic reactions after previous vaccinations, patient was given Benadryl before the shot was administered.  Within 30 minutes of the vaccination, patient started coughing, wheezing, and gasping for breath.  He was immediately given an albuterol inhaler.  Then his face swelled some, eyes started watering, nose running a TON, drooling from his mouth.  He began acting dazed and dropped to the ground crawling rather than walking anymore.  Was monitored by his pediatrician for about 20 minutes more until deemed fit enough to be taken home.  On the drive home he just stared into space and was still having very labored breathing. After getting home, he was given another inhaler and Benadryl dose. For about 3 more hours he had severe congestion and difficulty breathing but fell asleep.  That day and the next day he would only crawl and not walk.  He also developed some eczema on his arms, legs, and chest.  Over the next week he resumed walking a normal activities but was very clumsy.  For almost 3 months following the initial reaction he would lose control of his bladder during tantrums/meltdown and had difficulty doing things like controlling his urine stream which he had done fine for several months before the vaccinations (he had already been using the toilet before the reaction but was unable to for at least a month afterward).  He had also been jumping for a few months and could no longer jump for about 2 months following.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Dyspnoea, Eczema, Lacrimation increased, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Due to allergic reactions after previous vaccinations, patient was given Benadryl before the shot was administered.  Within 30 minutes of the vaccination, patient started coughing, wheezing, and gasping for breath.  He was immediately given an albuterol inhaler.  Then his face swelled some, eyes started watering, nose running a TON, drooling from his mouth.  He began acting dazed and dropped to the ground crawling rather than walking anymore.  Was monitored by his pediatrician for about 20 minutes more until deemed fit enough to be taken home.  On the drive home he just stared into space and was still having very labored breathing. After getting home, he was given another inhaler and Benadryl dose. For about 3 more hours he had severe congestion and difficulty breathing but fell asleep.  That day and the next day he would only crawl and not walk.  He also developed some eczema on his arms, legs, and chest.  Over the next week he resumed walking a normal activities but was very clumsy.  For almost 3 months following the initial reaction he would lose control of his bladder during tantrums/meltdown and had difficulty doing things like controlling his urine stream which he had done fine for several months before the vaccinations (he had already been using the toilet before the reaction but was unable to for at least a month afterward).  He had also been jumping for a few months and could no longer jump for about 2 months following.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Staring, Swelling face, Urinary incontinence, Wheezing
Clinical narrative: Due to allergic reactions after previous vaccinations, patient was given Benadryl before the shot was administered.  Within 30 minutes of the vaccination, patient started coughing, wheezing, and gasping for breath.  He was immediately given an albuterol inhaler.  Then his face swelled some, eyes started watering, nose running a TON, drooling from his mouth.  He began acting dazed and dropped to the ground crawling rather than walking anymore.  Was monitored by his pediatrician for about 20 minutes more until deemed fit enough to be taken home.  On the drive home he just stared into space and was still having very labored breathing. After getting home, he was given another inhaler and Benadryl dose. For about 3 more hours he had severe congestion and difficulty breathing but fell asleep.  That day and the next day he would only crawl and not walk.  He also developed some eczema on his arms, legs, and chest.  Over the next week he resumed walking a normal activities but was very clumsy.  For almost 3 months following the initial reaction he would lose control of his bladder during tantrums/meltdown and had difficulty doing things like controlling his urine stream which he had done fine for several months before the vaccinations (he had already been using the toilet before the reaction but was unable to for at least a month afterward).  He had also been jumping for a few months and could no longer jump for about 2 months following.
Age: 31.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Dizziness, Dysstasia, Fall, Fatigue, Headache
Clinical narrative: Extreme fatigue, severe dizziness, possibly fainted for unknown amount of time or fell, nausea, headache, unable to stand without holding on to something.  Symptoms lessened the next day and where gone after 2nd day. Thimerosal free shot was the one administered.
Age: 31.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Nausea, Syncope
Clinical narrative: Extreme fatigue, severe dizziness, possibly fainted for unknown amount of time or fell, nausea, headache, unable to stand without holding on to something.  Symptoms lessened the next day and where gone after 2nd day. Thimerosal free shot was the one administered.
Age: 43.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Blood test, Chest X-ray, Chest pain, Discomfort, Dyspnoea
Clinical narrative: Difficulty breathing, chest pains, fever, pain and discomfort.
Age: 43.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Electrocardiogram, Pain, Pyrexia
Clinical narrative: Difficulty breathing, chest pains, fever, pain and discomfort.
Sex: U
Vaccine: FLUX
Symptoms: Hypoglycaemia, Pneumonia aspiration
Clinical narrative: Initial case report received from executive director on 19 Nov 2009. A elderly patient was vaccinated IM with INFLUENZA virus vaccine (batch no. unspecified) on an unknown date. They experienced aspiration pneumonia and hypoglycaemia. The patient's outcome was unknown. Company assessment: On a case level, the case was considered unexpected. Serious criterion: Hospitalized Causality: Possible (Temporal relationship plausible or reasonable) Expectedness assessment according to EU SPC/US SPC: Aspiration pneumonia and hypoglycaemia are unexpected after vaccination with INFLUENZA virus vaccine. No change in benefit-risk ratio. No measures required.
Sex: U
Vaccine: FLUX
Symptoms: Hypoglycaemia, Pneumonia aspiration
Clinical narrative: Initial case received from a executive director via agency on 19 NOV 2009. A elderly patient was vaccinated i.m. with Influenza virus vaccine (batch no. unspecified) on an unknown date. They experienced aspiration pneumonia and hypoglycaemia. The patient's outcome was unknown. Company assessment: On a case level, the case was considered unexpected. Seriousness criterion: Hospitalised Causality: Possible (Temporal relationship plausible or reasonable) Expectedness assessment according to the agency: Aspiration pneumonia and hypoglycaemia are unexpected after vaccination with influenza virus vaccine. No change in benefit-risk ratio: No measures required. Agency reference no: NA09-008595
Age: 37.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Feeling hot, Flushing, Pharyngeal oedema, Pruritus
Clinical narrative: Having itching, throat swelling, feeling flushed/hot. In ER by 1120. IV Benadryl given in ER. 12/10/2009 ED records for 11/23/2009, patient with c/o's itching, feeling flushed and throat swelling, Tx: IV Benadryl, sx resolved. DC Dx vaccine allergie reaction
Age: 72.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Erythema, Eyelid oedema, Face oedema
Clinical narrative: Facial and eyelid edema and redness at 11:00pm. Treated 11/20/2009 with Medrol Pak and Atarax 25 mg at HS.
Age: 11.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Eye swelling, Oropharyngeal pain, Sneezing, Swelling face
Clinical narrative: 11-13-09 received intranasal H1N1 vaccine. 11-16-09 - awoke with swollen (R) cheek & around eye. Mom gave BENADRYL which helped swelling. No fever mild sore throat in AM. Hx of seasonal allergies/occas. sneezing.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Tenderness
Clinical narrative: Red, slightly tender area from the lower deltoid area to below the elbow.
Age: 41.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Ageusia, Facial palsy, Headache, Neck pain, Rash
Clinical narrative: Started with neck pain and headaches on the right side. These continued through the next few days. Two days later I had lost my sense of taste. The next day the right side of my face became paralyzed, affecting my mouth, eye lids, and cheeks. This continued for about two weeks until gradually beginning to subside after being put under a doctors care. I later broke out in a rash but they believe this was due to a reaction I had to medication prescribed for this condition.
Age: 22.0
Sex: M
Vaccine: TDAP, UNK
Symptoms: Loss of consciousness, Muscle tightness
Clinical narrative: Passed out, muscles were tightened, was eased down to floor
Age: 11.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Cough, Oropharyngeal pain, Pyrexia
Clinical narrative: Sore throat, cough began. Cough got worse and fever began slowly on 11/21/09, fever of 101 to 102 for two days through 11/23/09- cough continued through 11/24/09.
Age: 1.05
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: PT received varicella immunization 11-24-09 on 11-26-09 mother noted rash on pt.  On 11-27-09 pt was seen again at clinic and was dx with chicken pox.
Age: 28.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Rash, Skin lesion
Clinical narrative: Fine rash that spread to large lesions, no change from Benadryl or steroid based creams. Continuing to break out on 12/1/09.
Age: 1.03
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC
Symptoms: Pyrexia, Rash, Rhinorrhoea
Clinical narrative: Patient here for well child physical exam. Had symptoms of Rhinorrhea. Patient was behind in her immunizations. Received influenza IM, HIB #3, PREVNAR #3, and PENTACEL #3. Mom brought patient back next day with reported fever of 103.5 F. No other symptoms UR rash.
Age: 64.0
Sex: F
Vaccine: FLU(H1N1), TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right arm (deltoid) swelling, redness, heat. Went to ER received Medrol dose pack for reaction.
Age: 21.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Dyspnoea, Feeling cold, Myalgia, Nausea
Clinical narrative: SOB, lightheaded, chilled, myalgia, and nausea. 24 hours later-better.
Age: 40.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Convulsion, Electroencephalogram normal, Gait disturbance, Nuclear magnetic resonance imaging brain normal, Speech disorder
Clinical narrative: Patient reported tremors of hands (shakes) 3 days post-injection.  One month post-injection had an "episode" of severe shaking & tremors "like a seizure" and speech and gait were affected also (11/20/09).
Age: 40.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Tremor
Clinical narrative: Patient reported tremors of hands (shakes) 3 days post-injection.  One month post-injection had an "episode" of severe shaking & tremors "like a seizure" and speech and gait were affected also (11/20/09).
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Feeling cold, Oropharyngeal pain, Sneezing
Clinical narrative: Within one hour of the shot I got very cold, I started sneezing and got a sore throat.  I also miscarried.  This all happened within one hour of receiving the shot 12/4/09 Medical records received for date 11/25/08 and 11/2/09. DX: annual gyn exam WNL. OV 11/2/09 infertility consult. Pt denies knowledge of any prev. pregnancies seek consult for no conception over past year.
Age: 64.0
Sex: F
Vaccine: FLU(H1N1), FLU3, PPV
Symptoms: Chills, Headache, Pyrexia, Rash
Clinical narrative: Pt described having a sudden fever, headache, chills and rash - treated with TYLENOL for fever and headache, and BENADRYL for rash.
Age: 20.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Hypoaesthesia, Injection site anaesthesia, Paraesthesia
Clinical narrative: Tingling & numbness at injection site (right deltoid), tingling & numbness continued down right arm into hand, at 10 am symptoms starting to resolve.
Age: 8.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Urticaria
Clinical narrative: Patient developed hives on 11/14/09 at 6:15p. The hives started on the thigh and spread to the calf, then to the other calf and thigh. Hive "migrated" to different areas of her body - covering 1/3 of her body at a time. CALADRYL lotion was applied with some relief. She took BENADRYL at bedtime. Hive returned evening of 11/15; same distribution. She had BENADRYL 11/15 at bedtime. Hive again 11/16 evening.
Age: 39.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site urticaria, Presyncope
Clinical narrative: Near syncope.  Place head between legs then placed patient on floor with feet up.  Vital signs stable with BP dropping to 80/50 but rising to 100/80 with recumbency.   EMS activated and responded.  Patient taken by EMS and treated and released.  Adverse reaction report was incorrect. Patient had a local hive like reaction at the injection site, treated at the clinic with ice.Discharged home.
Age: 0.94
Sex: F
Vaccine: FLUX
Symptoms: Aldolase increased, Blood creatine phosphokinase increased, Blood culture negative, Convulsion, Culture negative
Clinical narrative: Mom reports subjective fever, decreased oral feeding and then shaking and seizure like episodes for "a few days".  Patient admitted to the hospital 11/25/09 and found to have elevated aldolase and CK.
Age: 0.94
Sex: F
Vaccine: FLUX
Symptoms: Electroencephalogram normal, Hypophagia, Influenza serology negative, Pyrexia, Tremor
Clinical narrative: Mom reports subjective fever, decreased oral feeding and then shaking and seizure like episodes for "a few days".  Patient admitted to the hospital 11/25/09 and found to have elevated aldolase and CK.