chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Heart rate increased, Hypertension, Inappropriate schedule of drug administration, Loss of consciousness, Nuclear magnetic resonance imaging
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 28 year old female patient with no medical history reported and no known drug allergies who on 24-JUN-2008, was vaccinated with her second dose of GARDASIL (Lot # not reported) into the left arm.  There was no concomitant medication.  On 30-JUN-2008, 6 days after receiving the second dose, the patient had a seizure and was rushed to the hospital.  Before the seizure, the patient did not have any signs or symptoms of anything wrong.  The patient went to school and work as usual up until the event.  The seizure took place around 1500 PM on 30-JUN-2008.  After receiving treatment (oxygen) from the EMTs, the patient regained consciousness and was very confused.  In the emergency room, the patient had unusually high blood pressure and rapid heart beat.  The patient was admitted to the hospital where the patient has a blood test.  Electroencephalogram (EEG), Magnetic Resonance Imaging (MRI), saw a cardiologist and received a heart monitor.  All test came back normal, therefore no treatment/medication was administered by my neurologist.  Upcoming test include following up with cardiologist and a sleep Electroencephalogram (EEG) test per neurologist recommendation.  The listing also indicated that one or more of the events was life-threatening.  This was originally reported by a consumer.  VAERS ID # 319459.  No further information is available.
Age: 28.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Blood test normal, Confusional state, Convulsion, Electroencephalogram normal, Heart rate 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 28 year old female patient with no medical history reported and no known drug allergies who on 24-JUN-2008, was vaccinated with her second dose of GARDASIL (Lot # not reported) into the left arm.  There was no concomitant medication.  On 30-JUN-2008, 6 days after receiving the second dose, the patient had a seizure and was rushed to the hospital.  Before the seizure, the patient did not have any signs or symptoms of anything wrong.  The patient went to school and work as usual up until the event.  The seizure took place around 1500 PM on 30-JUN-2008.  After receiving treatment (oxygen) from the EMTs, the patient regained consciousness and was very confused.  In the emergency room, the patient had unusually high blood pressure and rapid heart beat.  The patient was admitted to the hospital where the patient has a blood test.  Electroencephalogram (EEG), Magnetic Resonance Imaging (MRI), saw a cardiologist and received a heart monitor.  All test came back normal, therefore no treatment/medication was administered by my neurologist.  Upcoming test include following up with cardiologist and a sleep Electroencephalogram (EEG) test per neurologist recommendation.  The listing also indicated that one or more of the events was life-threatening.  This was originally reported by a consumer.  VAERS ID # 319459.  No further information is available.
Age: 28.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Hypertension, Inappropriate schedule of drug administration, Loss of consciousness, Nuclear magnetic resonance imaging normal, Oxygen supplementation
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 28 year old female patient with no medical history reported and no known drug allergies who on 24-JUN-2008, was vaccinated with her second dose of GARDASIL (Lot # not reported) into the left arm.  There was no concomitant medication.  On 30-JUN-2008, 6 days after receiving the second dose, the patient had a seizure and was rushed to the hospital.  Before the seizure, the patient did not have any signs or symptoms of anything wrong.  The patient went to school and work as usual up until the event.  The seizure took place around 1500 PM on 30-JUN-2008.  After receiving treatment (oxygen) from the EMTs, the patient regained consciousness and was very confused.  In the emergency room, the patient had unusually high blood pressure and rapid heart beat.  The patient was admitted to the hospital where the patient has a blood test.  Electroencephalogram (EEG), Magnetic Resonance Imaging (MRI), saw a cardiologist and received a heart monitor.  All test came back normal, therefore no treatment/medication was administered by my neurologist.  Upcoming test include following up with cardiologist and a sleep Electroencephalogram (EEG) test per neurologist recommendation.  The listing also indicated that one or more of the events was life-threatening.  This was originally reported by a consumer.  VAERS ID # 319459.  No further information is available.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Haematochezia, Intussusception
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 7 month old male patient with no known pertinent medical history and no known pre-illness, was vaccinated with the third dose of ROTATEQ (Lot # 657360/0508U) by mouth.  Concomitant therapy included the third dose of PEDIARIX (Lot # AC210127AA), a third dose of PREVNAR (Lot no C35171), and the third dose of Hib (unspecified carrier).  On 30-JUL-2008, the patient presented with abdominal pain, vomiting, x10-12 and bloody stool.  Intussusception was noted on Barium enema following a positive ultrasound.  Air intussusception reduced successfully, and it was reported because of the association of ROTATEQ immunization and intussusception.  The patient was discharged with diagnosis of: status post reduction of intussusception.  The patient was admitted for observation with no further problems.  Abdominal x ray was performed which was not specified.  An ultrasound of the abdomen was performed and was positive for intussusception of the middle abdomen.  A barium enema was positive for "IS".  A cell blood count, blood chemistry and urine analysis were performed, and the results were unremarkable.  An urine culture was performed and the result was negative.  The reporter considered the event to be serious due hospitalization and life threatening.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the center and was released.  The original reporting source was not provided.  The Vaers ID# is 323038-1.  No further information is available.  This report was filed with the FDA.  The VAERS ID# is 323038-1.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Abdominal pain, Barium enema abnormal, Culture urine negative, Enema administration
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 7 month old male patient with no known pertinent medical history and no known pre-illness, was vaccinated with the third dose of ROTATEQ (Lot # 657360/0508U) by mouth.  Concomitant therapy included the third dose of PEDIARIX (Lot # AC210127AA), a third dose of PREVNAR (Lot no C35171), and the third dose of Hib (unspecified carrier).  On 30-JUL-2008, the patient presented with abdominal pain, vomiting, x10-12 and bloody stool.  Intussusception was noted on Barium enema following a positive ultrasound.  Air intussusception reduced successfully, and it was reported because of the association of ROTATEQ immunization and intussusception.  The patient was discharged with diagnosis of: status post reduction of intussusception.  The patient was admitted for observation with no further problems.  Abdominal x ray was performed which was not specified.  An ultrasound of the abdomen was performed and was positive for intussusception of the middle abdomen.  A barium enema was positive for "IS".  A cell blood count, blood chemistry and urine analysis were performed, and the results were unremarkable.  An urine culture was performed and the result was negative.  The reporter considered the event to be serious due hospitalization and life threatening.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the center and was released.  The original reporting source was not provided.  The Vaers ID# is 323038-1.  No further information is available.  This report was filed with the FDA.  The VAERS ID# is 323038-1.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Full blood count normal, Haematochezia, Intussusception, Laboratory test normal, Red blood cell count normal
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 7 month old male patient with no known pertinent medical history and no known pre-illness, was vaccinated with the third dose of ROTATEQ (Lot # 657360/0508U) by mouth.  Concomitant therapy included the third dose of PEDIARIX (Lot # AC210127AA), a third dose of PREVNAR (Lot no C35171), and the third dose of Hib (unspecified carrier).  On 30-JUL-2008, the patient presented with abdominal pain, vomiting, x10-12 and bloody stool.  Intussusception was noted on Barium enema following a positive ultrasound.  Air intussusception reduced successfully, and it was reported because of the association of ROTATEQ immunization and intussusception.  The patient was discharged with diagnosis of: status post reduction of intussusception.  The patient was admitted for observation with no further problems.  Abdominal x ray was performed which was not specified.  An ultrasound of the abdomen was performed and was positive for intussusception of the middle abdomen.  A barium enema was positive for "IS".  A cell blood count, blood chemistry and urine analysis were performed, and the results were unremarkable.  An urine culture was performed and the result was negative.  The reporter considered the event to be serious due hospitalization and life threatening.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the center and was released.  The original reporting source was not provided.  The Vaers ID# is 323038-1.  No further information is available.  This report was filed with the FDA.  The VAERS ID# is 323038-1.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Ultrasound abdomen abnormal, Urine analysis normal, Vomiting
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 7 month old male patient with no known pertinent medical history and no known pre-illness, was vaccinated with the third dose of ROTATEQ (Lot # 657360/0508U) by mouth.  Concomitant therapy included the third dose of PEDIARIX (Lot # AC210127AA), a third dose of PREVNAR (Lot no C35171), and the third dose of Hib (unspecified carrier).  On 30-JUL-2008, the patient presented with abdominal pain, vomiting, x10-12 and bloody stool.  Intussusception was noted on Barium enema following a positive ultrasound.  Air intussusception reduced successfully, and it was reported because of the association of ROTATEQ immunization and intussusception.  The patient was discharged with diagnosis of: status post reduction of intussusception.  The patient was admitted for observation with no further problems.  Abdominal x ray was performed which was not specified.  An ultrasound of the abdomen was performed and was positive for intussusception of the middle abdomen.  A barium enema was positive for "IS".  A cell blood count, blood chemistry and urine analysis were performed, and the results were unremarkable.  An urine culture was performed and the result was negative.  The reporter considered the event to be serious due hospitalization and life threatening.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the center and was released.  The original reporting source was not provided.  The Vaers ID# is 323038-1.  No further information is available.  This report was filed with the FDA.  The VAERS ID# is 323038-1.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, HEP, MMR, PNC, VARCEL, DTAPIPVHIB, HEP, MMR, PNC, VARCEL
Symptoms: Blood culture negative, CSF test normal, Convulsion, Culture urine negative, Pyrexia
Clinical narrative: Acute complications: Unconsciousness within 24 hours of vaccination being administered; Recurrent seizures within 24 hours of vaccinations being administered; Persistent Fever lasting more than three (3) days despite treatment with Tylenol & Ibuprofen; Seizures treated with Phenobarbital loading. Several periods of unconsciousness happening intermittently within 20-48 hours of vaccinations being administered. Transport by ambulance to Medical Center then relocated by ambulance to another Medical Center. Within 6 hours of seizures, patient still showed signs of confusion & difficulty maintaining eye contact. Within 48 hours of vaccination administration, patient had not recovered basic motor skills for his age (i.e., picking up food and putting it in his mouth or chewing & swallowing)and lacked physical capabilities he previously had (i.e., could not sit up unassisted, could not stand or walk on his own).
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, HEP, MMR, PNC, VARCEL, DTAPIPVHIB, HEP, MMR, PNC, VARCEL
Symptoms: Blood culture negative, Confusional state, Convulsion, Culture urine negative, Disturbance in attention
Clinical narrative: Acute complications: Unconsciousness within 24 hours of vaccination being administered; Recurrent seizures within 24 hours of vaccinations being administered; Persistent Fever lasting more than three (3) days despite treatment with Tylenol & Ibuprofen; Seizures treated with Phenobarbital loading. Several periods of unconsciousness happening intermittently within 20-48 hours of vaccinations being administered. Transport by ambulance to Medical Center then relocated by ambulance to another Medical Center. Within 6 hours of seizures, patient still showed signs of confusion & difficulty maintaining eye contact. Within 48 hours of vaccination administration, patient had not recovered basic motor skills for his age (i.e., picking up food and putting it in his mouth or chewing & swallowing)and lacked physical capabilities he previously had (i.e., could not sit up unassisted, could not stand or walk on his own).
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, HEP, MMR, PNC, VARCEL, DTAPIPVHIB, HEP, MMR, PNC, VARCEL
Symptoms: Dysstasia, Electroencephalogram normal, Gait disturbance, Hypokinesia, Loss of consciousness
Clinical narrative: Acute complications: Unconsciousness within 24 hours of vaccination being administered; Recurrent seizures within 24 hours of vaccinations being administered; Persistent Fever lasting more than three (3) days despite treatment with Tylenol & Ibuprofen; Seizures treated with Phenobarbital loading. Several periods of unconsciousness happening intermittently within 20-48 hours of vaccinations being administered. Transport by ambulance to Medical Center then relocated by ambulance to another Medical Center. Within 6 hours of seizures, patient still showed signs of confusion & difficulty maintaining eye contact. Within 48 hours of vaccination administration, patient had not recovered basic motor skills for his age (i.e., picking up food and putting it in his mouth or chewing & swallowing)and lacked physical capabilities he previously had (i.e., could not sit up unassisted, could not stand or walk on his own).
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, HEP, MMR, PNC, VARCEL, DTAPIPVHIB, HEP, MMR, PNC, VARCEL
Symptoms: Lumbar puncture normal, Psychomotor skills impaired, Pyrexia
Clinical narrative: Acute complications: Unconsciousness within 24 hours of vaccination being administered; Recurrent seizures within 24 hours of vaccinations being administered; Persistent Fever lasting more than three (3) days despite treatment with Tylenol & Ibuprofen; Seizures treated with Phenobarbital loading. Several periods of unconsciousness happening intermittently within 20-48 hours of vaccinations being administered. Transport by ambulance to Medical Center then relocated by ambulance to another Medical Center. Within 6 hours of seizures, patient still showed signs of confusion & difficulty maintaining eye contact. Within 48 hours of vaccination administration, patient had not recovered basic motor skills for his age (i.e., picking up food and putting it in his mouth or chewing & swallowing)and lacked physical capabilities he previously had (i.e., could not sit up unassisted, could not stand or walk on his own).
Age: 16.0
Sex: F
Vaccine: HPV4, TDAP, DTAP, HPV4
Symptoms: Headache, Hypoaesthesia, Neck pain, Pain, 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 16 year old female patient with depression and anxiety, who on 17-AUG-2007, was vaccinated with her first dose of GARDASIL (Lot # 655620/0171U) into her right arm and INFANRIX (Lot # AC52B015AA) into the left arm. Concomitant therapy included PROZAC. The patient experienced severe neck pain, headache so bad she held her head screaming in pain, drop in white blood cell count to 1000, very high fever, uncontrollable shaking, hurting from head to toe and numbness in arms. MR received for date of service 21-AUG-2007 to 26-AUG-2007 with discharge diagnosis with viral syndrome. The patient presented with onset of severe headaches, myalgias, arthralgias and fever beginning on 18-AUG-2007. Seen in local ER for meningitis which work up was negative. Found to be pancytopenic so admitted for further work up. Severe headache treatment with intravenous and oral pain medicaments. Fevers up to 103 with infectious disease work up all negative. Pancytopenia improving. Had some electrolyte imbalances to be follow-up as output. Every test came back negative (meningitis, West Nile, mono etc.) Labs and diagnostics: cerebrospinal fluid (CSF): negative, Blood: negative, Head computed axial tomography: negative, Sinux x-ray: negative. Serum C-reactive protein test: 15.3. Erythrocyte sedimentation rate: 9-13; (SGOT): 92. SGPT 104. Total protein 5.0. Albumin 2.6. Serum Calcium 6.4 wi. The original reporting source was not provided. VAERS ID #: 325601. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4, TDAP, DTAP, HPV4
Symptoms: Screaming, Tremor, White blood cell count 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 16 year old female patient with depression and anxiety, who on 17-AUG-2007, was vaccinated with her first dose of GARDASIL (Lot # 655620/0171U) into her right arm and INFANRIX (Lot # AC52B015AA) into the left arm. Concomitant therapy included PROZAC. The patient experienced severe neck pain, headache so bad she held her head screaming in pain, drop in white blood cell count to 1000, very high fever, uncontrollable shaking, hurting from head to toe and numbness in arms. MR received for date of service 21-AUG-2007 to 26-AUG-2007 with discharge diagnosis with viral syndrome. The patient presented with onset of severe headaches, myalgias, arthralgias and fever beginning on 18-AUG-2007. Seen in local ER for meningitis which work up was negative. Found to be pancytopenic so admitted for further work up. Severe headache treatment with intravenous and oral pain medicaments. Fevers up to 103 with infectious disease work up all negative. Pancytopenia improving. Had some electrolyte imbalances to be follow-up as output. Every test came back negative (meningitis, West Nile, mono etc.) Labs and diagnostics: cerebrospinal fluid (CSF): negative, Blood: negative, Head computed axial tomography: negative, Sinux x-ray: negative. Serum C-reactive protein test: 15.3. Erythrocyte sedimentation rate: 9-13; (SGOT): 92. SGPT 104. Total protein 5.0. Albumin 2.6. Serum Calcium 6.4 wi. The original reporting source was not provided. VAERS ID #: 325601. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4, TDAP, DTAP, HPV4
Symptoms: Alanine aminotransferase increased, Arthralgia, Aspartate aminotransferase increased, Blood albumin decreased, Blood calcium 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 16 year old female patient with depression and anxiety, who on 17-AUG-2007, was vaccinated with her first dose of GARDASIL (Lot # 655620/0171U) into her right arm and INFANRIX (Lot # AC52B015AA) into the left arm. Concomitant therapy included PROZAC. The patient experienced severe neck pain, headache so bad she held her head screaming in pain, drop in white blood cell count to 1000, very high fever, uncontrollable shaking, hurting from head to toe and numbness in arms. MR received for date of service 21-AUG-2007 to 26-AUG-2007 with discharge diagnosis with viral syndrome. The patient presented with onset of severe headaches, myalgias, arthralgias and fever beginning on 18-AUG-2007. Seen in local ER for meningitis which work up was negative. Found to be pancytopenic so admitted for further work up. Severe headache treatment with intravenous and oral pain medicaments. Fevers up to 103 with infectious disease work up all negative. Pancytopenia improving. Had some electrolyte imbalances to be follow-up as output. Every test came back negative (meningitis, West Nile, mono etc.) Labs and diagnostics: cerebrospinal fluid (CSF): negative, Blood: negative, Head computed axial tomography: negative, Sinux x-ray: negative. Serum C-reactive protein test: 15.3. Erythrocyte sedimentation rate: 9-13; (SGOT): 92. SGPT 104. Total protein 5.0. Albumin 2.6. Serum Calcium 6.4 wi. The original reporting source was not provided. VAERS ID #: 325601. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4, TDAP, DTAP, HPV4
Symptoms: Blood culture negative, Body temperature increased, C-reactive protein increased, CSF test normal, Computerised tomogram head
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 patient with depression and anxiety, who on 17-AUG-2007, was vaccinated with her first dose of GARDASIL (Lot # 655620/0171U) into her right arm and INFANRIX (Lot # AC52B015AA) into the left arm. Concomitant therapy included PROZAC. The patient experienced severe neck pain, headache so bad she held her head screaming in pain, drop in white blood cell count to 1000, very high fever, uncontrollable shaking, hurting from head to toe and numbness in arms. MR received for date of service 21-AUG-2007 to 26-AUG-2007 with discharge diagnosis with viral syndrome. The patient presented with onset of severe headaches, myalgias, arthralgias and fever beginning on 18-AUG-2007. Seen in local ER for meningitis which work up was negative. Found to be pancytopenic so admitted for further work up. Severe headache treatment with intravenous and oral pain medicaments. Fevers up to 103 with infectious disease work up all negative. Pancytopenia improving. Had some electrolyte imbalances to be follow-up as output. Every test came back negative (meningitis, West Nile, mono etc.) Labs and diagnostics: cerebrospinal fluid (CSF): negative, Blood: negative, Head computed axial tomography: negative, Sinux x-ray: negative. Serum C-reactive protein test: 15.3. Erythrocyte sedimentation rate: 9-13; (SGOT): 92. SGPT 104. Total protein 5.0. Albumin 2.6. Serum Calcium 6.4 wi. The original reporting source was not provided. VAERS ID #: 325601. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4, TDAP, DTAP, HPV4
Symptoms: Computerised tomogram normal, Electrolyte imbalance, Epstein-Barr virus test negative, Face and mouth X-ray normal, 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 16 year old female patient with depression and anxiety, who on 17-AUG-2007, was vaccinated with her first dose of GARDASIL (Lot # 655620/0171U) into her right arm and INFANRIX (Lot # AC52B015AA) into the left arm. Concomitant therapy included PROZAC. The patient experienced severe neck pain, headache so bad she held her head screaming in pain, drop in white blood cell count to 1000, very high fever, uncontrollable shaking, hurting from head to toe and numbness in arms. MR received for date of service 21-AUG-2007 to 26-AUG-2007 with discharge diagnosis with viral syndrome. The patient presented with onset of severe headaches, myalgias, arthralgias and fever beginning on 18-AUG-2007. Seen in local ER for meningitis which work up was negative. Found to be pancytopenic so admitted for further work up. Severe headache treatment with intravenous and oral pain medicaments. Fevers up to 103 with infectious disease work up all negative. Pancytopenia improving. Had some electrolyte imbalances to be follow-up as output. Every test came back negative (meningitis, West Nile, mono etc.) Labs and diagnostics: cerebrospinal fluid (CSF): negative, Blood: negative, Head computed axial tomography: negative, Sinux x-ray: negative. Serum C-reactive protein test: 15.3. Erythrocyte sedimentation rate: 9-13; (SGOT): 92. SGPT 104. Total protein 5.0. Albumin 2.6. Serum Calcium 6.4 wi. The original reporting source was not provided. VAERS ID #: 325601. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4, TDAP, DTAP, HPV4
Symptoms: Hypoaesthesia, Myalgia, Neck pain, Pain, Pancytopenia
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 patient with depression and anxiety, who on 17-AUG-2007, was vaccinated with her first dose of GARDASIL (Lot # 655620/0171U) into her right arm and INFANRIX (Lot # AC52B015AA) into the left arm. Concomitant therapy included PROZAC. The patient experienced severe neck pain, headache so bad she held her head screaming in pain, drop in white blood cell count to 1000, very high fever, uncontrollable shaking, hurting from head to toe and numbness in arms. MR received for date of service 21-AUG-2007 to 26-AUG-2007 with discharge diagnosis with viral syndrome. The patient presented with onset of severe headaches, myalgias, arthralgias and fever beginning on 18-AUG-2007. Seen in local ER for meningitis which work up was negative. Found to be pancytopenic so admitted for further work up. Severe headache treatment with intravenous and oral pain medicaments. Fevers up to 103 with infectious disease work up all negative. Pancytopenia improving. Had some electrolyte imbalances to be follow-up as output. Every test came back negative (meningitis, West Nile, mono etc.) Labs and diagnostics: cerebrospinal fluid (CSF): negative, Blood: negative, Head computed axial tomography: negative, Sinux x-ray: negative. Serum C-reactive protein test: 15.3. Erythrocyte sedimentation rate: 9-13; (SGOT): 92. SGPT 104. Total protein 5.0. Albumin 2.6. Serum Calcium 6.4 wi. The original reporting source was not provided. VAERS ID #: 325601. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4, TDAP, DTAP, HPV4
Symptoms: Protein total decreased, Pyrexia, Red blood cell sedimentation rate normal, Screaming, Tremor
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 patient with depression and anxiety, who on 17-AUG-2007, was vaccinated with her first dose of GARDASIL (Lot # 655620/0171U) into her right arm and INFANRIX (Lot # AC52B015AA) into the left arm. Concomitant therapy included PROZAC. The patient experienced severe neck pain, headache so bad she held her head screaming in pain, drop in white blood cell count to 1000, very high fever, uncontrollable shaking, hurting from head to toe and numbness in arms. MR received for date of service 21-AUG-2007 to 26-AUG-2007 with discharge diagnosis with viral syndrome. The patient presented with onset of severe headaches, myalgias, arthralgias and fever beginning on 18-AUG-2007. Seen in local ER for meningitis which work up was negative. Found to be pancytopenic so admitted for further work up. Severe headache treatment with intravenous and oral pain medicaments. Fevers up to 103 with infectious disease work up all negative. Pancytopenia improving. Had some electrolyte imbalances to be follow-up as output. Every test came back negative (meningitis, West Nile, mono etc.) Labs and diagnostics: cerebrospinal fluid (CSF): negative, Blood: negative, Head computed axial tomography: negative, Sinux x-ray: negative. Serum C-reactive protein test: 15.3. Erythrocyte sedimentation rate: 9-13; (SGOT): 92. SGPT 104. Total protein 5.0. Albumin 2.6. Serum Calcium 6.4 wi. The original reporting source was not provided. VAERS ID #: 325601. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4, TDAP, DTAP, HPV4
Symptoms: Viral infection, Virus serology test negative, White blood cell count 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 16 year old female patient with depression and anxiety, who on 17-AUG-2007, was vaccinated with her first dose of GARDASIL (Lot # 655620/0171U) into her right arm and INFANRIX (Lot # AC52B015AA) into the left arm. Concomitant therapy included PROZAC. The patient experienced severe neck pain, headache so bad she held her head screaming in pain, drop in white blood cell count to 1000, very high fever, uncontrollable shaking, hurting from head to toe and numbness in arms. MR received for date of service 21-AUG-2007 to 26-AUG-2007 with discharge diagnosis with viral syndrome. The patient presented with onset of severe headaches, myalgias, arthralgias and fever beginning on 18-AUG-2007. Seen in local ER for meningitis which work up was negative. Found to be pancytopenic so admitted for further work up. Severe headache treatment with intravenous and oral pain medicaments. Fevers up to 103 with infectious disease work up all negative. Pancytopenia improving. Had some electrolyte imbalances to be follow-up as output. Every test came back negative (meningitis, West Nile, mono etc.) Labs and diagnostics: cerebrospinal fluid (CSF): negative, Blood: negative, Head computed axial tomography: negative, Sinux x-ray: negative. Serum C-reactive protein test: 15.3. Erythrocyte sedimentation rate: 9-13; (SGOT): 92. SGPT 104. Total protein 5.0. Albumin 2.6. Serum Calcium 6.4 wi. The original reporting source was not provided. VAERS ID #: 325601. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Electromyogram normal, Gait disturbance, Lipids normal, Lumbar puncture normal, Mental disorder
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 patient with no medical history reported and no known drug allergies, who on 18-JUN-2008, was vaccinated with her first dose of GARDASIL (Lot # 658554/0928U) into her left arm IM. No concomitant therapy at time of vaccination. The patient experienced weakness, trouble walking, psychiatric changes starting early September. Labs and diagnostics: Magnetic Resonance Imaging (MRI), Electromyogram (EMG), LP- normal and working with psychiatry. The listing indicated that one or more of the events required hospitalization. The original reporting source was not provided. VAERS ID #: 325604. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging normal
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 patient with no medical history reported and no known drug allergies, who on 18-JUN-2008, was vaccinated with her first dose of GARDASIL (Lot # 658554/0928U) into her left arm IM. No concomitant therapy at time of vaccination. The patient experienced weakness, trouble walking, psychiatric changes starting early September. Labs and diagnostics: Magnetic Resonance Imaging (MRI), Electromyogram (EMG), LP- normal and working with psychiatry. The listing indicated that one or more of the events required hospitalization. The original reporting source was not provided. VAERS ID #: 325604. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Electromyogram normal, Gait disturbance, Lumbar puncture normal, Mental disorder
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 patient with no medical history reported and no known drug allergies, who on 18-JUN-2008, was vaccinated with her first dose of GARDASIL (Lot # 658554/0928U) into her left arm IM. No concomitant therapy at time of vaccination. The patient experienced weakness, trouble walking, psychiatric changes starting early September. Labs and diagnostics: Magnetic Resonance Imaging (MRI), Electromyogram (EMG), LP- normal and working with psychiatry. The listing indicated that one or more of the events required hospitalization. The original reporting source was not provided. VAERS ID #: 325604. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nuclear magnetic resonance imaging normal
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 patient with no medical history reported and no known drug allergies, who on 18-JUN-2008, was vaccinated with her first dose of GARDASIL (Lot # 658554/0928U) into her left arm IM. No concomitant therapy at time of vaccination. The patient experienced weakness, trouble walking, psychiatric changes starting early September. Labs and diagnostics: Magnetic Resonance Imaging (MRI), Electromyogram (EMG), LP- normal and working with psychiatry. The listing indicated that one or more of the events required hospitalization. The original reporting source was not provided. VAERS ID #: 325604. No further information is available.
Age: 60.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Anxiety, Blister, Chest pain, Condition aggravated, Dizziness
Clinical narrative: Reason for admission - received flu shot 10-18-08 at approximately 0815, came to Emerg Dept on 10-18-08 at 1645 c/o itching and rash, was given Benadryl 50mg IM at 1758; returned to Emerg Dept 10-19-08 at 1038 w/ complaints of rash all over body and blisters and whelps, was given Solumedrol 125 IM and Vistaril 50mg IM; Returned 10-20-08 to Emerg Dept w/ complaints of CP mid/lt sternal on a scale of 8/10 along with lightheadedness and SOB; reports on admission that he is pain free but rash and blisters are returning. The Pt was admitted due to his hx of CAD, but it is felt he had an anxiety reaction to his continuing circumstances, as his chest pain resolved quickly upon admission without any actual treatment of the chest pain itself.
Age: 60.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Pruritus, Rash, Rash generalised, Urticaria
Clinical narrative: Reason for admission - received flu shot 10-18-08 at approximately 0815, came to Emerg Dept on 10-18-08 at 1645 c/o itching and rash, was given Benadryl 50mg IM at 1758; returned to Emerg Dept 10-19-08 at 1038 w/ complaints of rash all over body and blisters and whelps, was given Solumedrol 125 IM and Vistaril 50mg IM; Returned 10-20-08 to Emerg Dept w/ complaints of CP mid/lt sternal on a scale of 8/10 along with lightheadedness and SOB; reports on admission that he is pain free but rash and blisters are returning. The Pt was admitted due to his hx of CAD, but it is felt he had an anxiety reaction to his continuing circumstances, as his chest pain resolved quickly upon admission without any actual treatment of the chest pain itself.
Age: 60.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Pruritus, Rash generalised, Urticaria
Clinical narrative: Reason for admission - received flu shot 10-18-08 at approximately 0815, came to Emerg Dept on 10-18-08 at 1645 c/o itching and rash, was given Benadryl 50mg IM at 1758; returned to Emerg Dept 10-19-08 at 1038 w/ complaints of rash all over body and blisters and whelps, was given Solumedrol 125 IM and Vistaril 50mg IM; Returned 10-20-08 to Emerg Dept w/ complaints of CP mid/lt sternal on a scale of 8/10 along with lightheadedness and SOB; reports on admission that he is pain free but rash and blisters are returning. The Pt was admitted due to his hx of CAD, but it is felt he had an anxiety reaction to his continuing circumstances, as his chest pain resolved quickly upon admission without any actual treatment of the chest pain itself.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dysphagia, Dyspnoea, Pharyngeal oedema, Urticaria
Clinical narrative: (Per patient) 6 pm, flu shot. 9 pm same day, hives right flank. 12:00 am next morning, throat closing off. Called 911. Took to ER. IV Benadryl, oral prednisone. Discharged at 5 am 10-16-08.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Throat tightness, Urticaria
Clinical narrative: (Per patient) 6 pm, flu shot. 9 pm same day, hives right flank. 12:00 am next morning, throat closing off. Called 911. Took to ER. IV Benadryl, oral prednisone. Discharged at 5 am 10-16-08.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUN3, IPV, MMR, VARCEL, DTAP, FLUN3, IPV, MMR, VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: tactile fever, Vomiting X 1
Age: 9.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dysphonia, Pallor, Pyrexia, Upper respiratory tract congestion
Clinical narrative: hoarse, fever, severe congestion, pale, weak, vomitting excess mucus; ARNP prescribed Rondec cough syrup and is taking OTC motrin & tylenol
Age: 9.0
Sex: F
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: hoarse, fever, severe congestion, pale, weak, vomitting excess mucus; ARNP prescribed Rondec cough syrup and is taking OTC motrin & tylenol
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Cardiac arrest, Cerebrovascular accident, Death, Electrocardiogram T wave abnormal, Electrocardiogram abnormal
Clinical narrative: Information has been received from an investigator during a study concerning a 71 year old male with hypothyroidism (since 2006), hypertension (since 2006), chronic obstructive pulmonary disease (2001), prediabetes (2007), ex-smoker and occasional drinker who did not use recreational or street drugs, who on 31-JAN-2007 was vaccinated with ZOSTAVAX (Oka/Merck) (lot # 652936/0981F) at routine healthcare visit, including blood pressure and routine testing. Patient did not have concomitant vaccines. No complaints or concerns at this visit. Vitals on exam were within normal limits and on general exam patient was a well-developed, elderly, male, in no apparent distress, comfortable. Concomitant therapy included atenolol 50mg/d, therapy unspecified "LT4" 0.025mg/d and vardenafil 20mg/prn. On 25-FEB-2007 the patient presented at a facility and was noted as having a CVA and cardiac arrest. At this facility the patient had an EKG which was T-abnormal. The EKG impression included: QRS interval 89, QT interval 298, QT corrected 417, frontal axis initial -81, frontal axis mean QRS -77, frontal axis terminal -77, frontal axis ST 90, frontal axis T 85, left axis deviation, QRS axis -31 to -90; ventricular tachycardia, rate 118; since 2/4/05 VT now present. At the same day, the patient died. The cause of death was reported as cerebrovascular accident. At this time, relationship of CVA and cardiac arrest to study therapy is unknown. Upon internal review, cardiac arrest was determined to be an other important medical event. A lot check has been requested. This is one of several reports from the same source. Additional has been requested.   11/5/2008 Note received from FDA. Pt presented 2/25/07 and DX'd with CVA and cardiac arrest. 1/9/09-death certificate received-COD-Cardiac arrest.Ischemia of heart. Hypertension.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Peak expiratory flow rate, Ventricular tachycardia
Clinical narrative: Information has been received from an investigator during a study concerning a 71 year old male with hypothyroidism (since 2006), hypertension (since 2006), chronic obstructive pulmonary disease (2001), prediabetes (2007), ex-smoker and occasional drinker who did not use recreational or street drugs, who on 31-JAN-2007 was vaccinated with ZOSTAVAX (Oka/Merck) (lot # 652936/0981F) at routine healthcare visit, including blood pressure and routine testing. Patient did not have concomitant vaccines. No complaints or concerns at this visit. Vitals on exam were within normal limits and on general exam patient was a well-developed, elderly, male, in no apparent distress, comfortable. Concomitant therapy included atenolol 50mg/d, therapy unspecified "LT4" 0.025mg/d and vardenafil 20mg/prn. On 25-FEB-2007 the patient presented at a facility and was noted as having a CVA and cardiac arrest. At this facility the patient had an EKG which was T-abnormal. The EKG impression included: QRS interval 89, QT interval 298, QT corrected 417, frontal axis initial -81, frontal axis mean QRS -77, frontal axis terminal -77, frontal axis ST 90, frontal axis T 85, left axis deviation, QRS axis -31 to -90; ventricular tachycardia, rate 118; since 2/4/05 VT now present. At the same day, the patient died. The cause of death was reported as cerebrovascular accident. At this time, relationship of CVA and cardiac arrest to study therapy is unknown. Upon internal review, cardiac arrest was determined to be an other important medical event. A lot check has been requested. This is one of several reports from the same source. Additional has been requested.   11/5/2008 Note received from FDA. Pt presented 2/25/07 and DX'd with CVA and cardiac arrest. 1/9/09-death certificate received-COD-Cardiac arrest.Ischemia of heart. Hypertension.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Cardiac failure congestive, Chronic obstructive pulmonary disease, Condition aggravated, Death, Hospice care
Clinical narrative: Information has been received from an investigator concerning a 77 year old male with chronic obstructive pulmonary disease, Alzheimer's dementia, hypertension, congestive heart failure, peripheral vascular disease, hyperlipidaemia, glaucoma, gastrooesophageal reflux disease, shingles, chronic renal insufficiency and cigarette addiction and previous surgeries of appendicectomy, total hip arthroplasty, cataract surgery, bowel obstruction and right endarterectomy in July 1995 who on 18-JUN-2008 was vaccinated with ZOSTAVAX (Oka/Merck) (lot # 656412/1476F). This report was part of a study. The patient was hospitalized in May of 2008. On 12-JUN-2008, he was referred for Hospice care. On 10-JUL2008, he as admitted to a skilled nursing facility for Hospice care and died 34 days after vaccination, on 22-JUL-2008. The cause of death was COPD, HTN, PVD and CHF. A lot check has been requested. This is one of several reports received from the same source. Additional information has been requested. 1/9/09-death certificate received- COD-cardiopulmonary arrest. chronic obstructive pulmonary disease.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypertension, Peripheral vascular disorder
Clinical narrative: Information has been received from an investigator concerning a 77 year old male with chronic obstructive pulmonary disease, Alzheimer's dementia, hypertension, congestive heart failure, peripheral vascular disease, hyperlipidaemia, glaucoma, gastrooesophageal reflux disease, shingles, chronic renal insufficiency and cigarette addiction and previous surgeries of appendicectomy, total hip arthroplasty, cataract surgery, bowel obstruction and right endarterectomy in July 1995 who on 18-JUN-2008 was vaccinated with ZOSTAVAX (Oka/Merck) (lot # 656412/1476F). This report was part of a study. The patient was hospitalized in May of 2008. On 12-JUN-2008, he was referred for Hospice care. On 10-JUL2008, he as admitted to a skilled nursing facility for Hospice care and died 34 days after vaccination, on 22-JUL-2008. The cause of death was COPD, HTN, PVD and CHF. A lot check has been requested. This is one of several reports received from the same source. Additional information has been requested. 1/9/09-death certificate received- COD-cardiopulmonary arrest. chronic obstructive pulmonary disease.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac arrest, Cardiogenic shock, Death
Clinical narrative: Information has been received from an investigator during a study concerning a 64 year old female with a history of osteoporosis, elevated blood pressure, hyperlipidemia, atrial fibrillation in the past and recurrent dyspnea of uncertain etiology who on 25-JAN-2007, was vaccinated with ZOSTAVAX (Oka/Merck) (Lot# 652936/0981F).  The patient did not have concomitant vaccines.  The patient had sustained a recent lower back injury at work and was being seen by occupational medicine.  She was not anticoagulated.  She was last seen by her medical provider on 25-JAN-2007, the day of vaccination, and was doing well.  The patient suddenly expired on 04-MAR-2007.  Her death certificate gives cause of death as cardiac arrest and cardiogenic shock.  A lot check has been requested.  This is one of several reports received from the same source.  Additional information has been request.  11/5/2008 Death Cert and  note received from FDA. Pt expired suddenly on 3/04/2007. COD Cardiac Arrest and Cardiogenic Shock.
Age: 12.0
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning a 12 year old male who on an unknown date was vaccinated with MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3). The consumer reported that the patient developed autism after getting MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3). The caller believes it was "overnight." Caller reported "woman in a parent group mentioned everyone she talked to whose kids have autism claimed it happened overnight after they got MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3). There was no product quality complaint. Upon internal review, autism was determined to be an other important medical event. This is one of two reports received from the same source. No further information is expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Ultrasound scan abnormal
Clinical narrative: Initial and follow-up information has been received from the Merck Pregnancy Registry via a registered nurse and a physician concerning a 26 year old female with anxiety and hay fever who on 06-AUG-2007 was vaccinated intramuscularly with a 0.5 ml first dose of GARDASIL (lot # 658282/0929U). There was no concomitant medication. On 24-AUG-2007 the patient was seen in the office for pregnancy. The patient's last menstrual period was on 29-JUN-2007 (previously reported as 15-JUN-2008) and the estimated date of delivery on 21-MAR-2008. The physician reported that the patient had a miscarriage at 8 weeks and 6 days, on 29-AUG-2007. An ultrasound was done at 10 weeks, approximately on 13-Sep-2007, which showed demise from 2 weeks prior. Upon internal review, miscarriage was considered an other important medical event. Additional information is not expected.