chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, HPV4, MNQ, HPV4, MNQ
Symptoms: Computerised tomogram abnormal, Fall, Head injury, Headache, Neck pain
Clinical narrative: This report was received from another manufacturer on 07 June 2007 (reference number WAES0705USA05078). The following is verbatim: "This report was identified from a line listing on request by the Company from the FDA under the Freedom of Information Act. A 13 year old female patient with a penicillin allergy, was vaccinated on 03-APR-2007 with the first dose of Gardasil (Lot #657006/0188U), and the first dose of MENACTRA (Lot #U226AA). The listing indicated that within 10 minutes of receiving the vaccinations, she fell backward and hit her head on the carpeted floor, and was transported to the ER. The patient experienced syncope, a fall, head injury, headache, neck pain, subarachnoid hemorrhage, and was unresponsive to stimuli. A computerized tomography (CT) in the ER was abnormal, and showed traumatic subarachnoid hemorrhage. The listing indicated that one or more of the events required a visit to the emergency room and resulted in hospitalization in the pediatric intensive care unit (PICU). No further information is available. The original reporting source was not provided."
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, HPV4, MNQ, HPV4, MNQ
Symptoms: Subarachnoid haemorrhage, Syncope, Unresponsive to stimuli
Clinical narrative: This report was received from another manufacturer on 07 June 2007 (reference number WAES0705USA05078). The following is verbatim: "This report was identified from a line listing on request by the Company from the FDA under the Freedom of Information Act. A 13 year old female patient with a penicillin allergy, was vaccinated on 03-APR-2007 with the first dose of Gardasil (Lot #657006/0188U), and the first dose of MENACTRA (Lot #U226AA). The listing indicated that within 10 minutes of receiving the vaccinations, she fell backward and hit her head on the carpeted floor, and was transported to the ER. The patient experienced syncope, a fall, head injury, headache, neck pain, subarachnoid hemorrhage, and was unresponsive to stimuli. A computerized tomography (CT) in the ER was abnormal, and showed traumatic subarachnoid hemorrhage. The listing indicated that one or more of the events required a visit to the emergency room and resulted in hospitalization in the pediatric intensive care unit (PICU). No further information is available. The original reporting source was not provided."
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, HPV4, MNQ, HPV4, MNQ
Symptoms: Dizziness, Fall, Head injury, Intensive care
Clinical narrative: This report was received from another manufacturer on 07 June 2007 (reference number WAES0705USA05078). The following is verbatim: "This report was identified from a line listing on request by the Company from the FDA under the Freedom of Information Act. A 13 year old female patient with a penicillin allergy, was vaccinated on 03-APR-2007 with the first dose of Gardasil (Lot #657006/0188U), and the first dose of MENACTRA (Lot #U226AA). The listing indicated that within 10 minutes of receiving the vaccinations, she fell backward and hit her head on the carpeted floor, and was transported to the ER. The patient experienced syncope, a fall, head injury, headache, neck pain, subarachnoid hemorrhage, and was unresponsive to stimuli. A computerized tomography (CT) in the ER was abnormal, and showed traumatic subarachnoid hemorrhage. The listing indicated that one or more of the events required a visit to the emergency room and resulted in hospitalization in the pediatric intensive care unit (PICU). No further information is available. The original reporting source was not provided."
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, HPV4, MNQ, HPV4, MNQ
Symptoms: Dizziness, Fall, Head injury
Clinical narrative: This report was received from another manufacturer on 07 June 2007 (reference number WAES0705USA05078). The following is verbatim: "This report was identified from a line listing on request by the Company from the FDA under the Freedom of Information Act. A 13 year old female patient with a penicillin allergy, was vaccinated on 03-APR-2007 with the first dose of Gardasil (Lot #657006/0188U), and the first dose of MENACTRA (Lot #U226AA). The listing indicated that within 10 minutes of receiving the vaccinations, she fell backward and hit her head on the carpeted floor, and was transported to the ER. The patient experienced syncope, a fall, head injury, headache, neck pain, subarachnoid hemorrhage, and was unresponsive to stimuli. A computerized tomography (CT) in the ER was abnormal, and showed traumatic subarachnoid hemorrhage. The listing indicated that one or more of the events required a visit to the emergency room and resulted in hospitalization in the pediatric intensive care unit (PICU). No further information is available. The original reporting source was not provided."
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Chest X-ray, Computerised tomogram, Echocardiogram, Electrocardiogram, Electroencephalogram
Clinical narrative: Initial information received on 07 June 2007 from another manufacturer, report# WAES0705USA05083. The initial reporter to this manufacturer had been the FDA, VAERS# not provided. Verbatim from the report: "Information has been received on request from the FDA under the Freedom of Information Act regarding a 12 year old female patient with a history of headaches, depression and systolic murmur, who on 29-MAR-2007 was vaccinated IM into the right arm with a first dose of Gardasil (Lot# 654535/0960F). Concomitant therapy given on 29-MAR-2007 IM into the left arm included a first dose of MENACTRA (Lot# U2061AA). On 29-MAR-2007, the patient collapsed 15 to 20 minutes after receiving the vaccines. The patient was hospitalized and lab data included a beta-human chorionic gonadotropin test (unspecified), chest x-ray, complete blood cell count, "LMP", echocardiography, electrocardiogram, electroencephalography, head computed axial tomography, and white blood cell differential. At the time of this report, the patient's outcome was unknown. The original reporting source was not provided. No further information is available."
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Full blood count, Pregnancy test
Clinical narrative: Initial information received on 07 June 2007 from another manufacturer, report# WAES0705USA05083. The initial reporter to this manufacturer had been the FDA, VAERS# not provided. Verbatim from the report: "Information has been received on request from the FDA under the Freedom of Information Act regarding a 12 year old female patient with a history of headaches, depression and systolic murmur, who on 29-MAR-2007 was vaccinated IM into the right arm with a first dose of Gardasil (Lot# 654535/0960F). Concomitant therapy given on 29-MAR-2007 IM into the left arm included a first dose of MENACTRA (Lot# U2061AA). On 29-MAR-2007, the patient collapsed 15 to 20 minutes after receiving the vaccines. The patient was hospitalized and lab data included a beta-human chorionic gonadotropin test (unspecified), chest x-ray, complete blood cell count, "LMP", echocardiography, electrocardiogram, electroencephalography, head computed axial tomography, and white blood cell differential. At the time of this report, the patient's outcome was unknown. The original reporting source was not provided. No further information is available."
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Chest X-ray, Circulatory collapse, Computerised tomogram, Echocardiogram, Electrocardiogram
Clinical narrative: Initial information received on 07 June 2007 from another manufacturer, report# WAES0705USA05083. The initial reporter to this manufacturer had been the FDA, VAERS# not provided. Verbatim from the report: "Information has been received on request from the FDA under the Freedom of Information Act regarding a 12 year old female patient with a history of headaches, depression and systolic murmur, who on 29-MAR-2007 was vaccinated IM into the right arm with a first dose of Gardasil (Lot# 654535/0960F). Concomitant therapy given on 29-MAR-2007 IM into the left arm included a first dose of MENACTRA (Lot# U2061AA). On 29-MAR-2007, the patient collapsed 15 to 20 minutes after receiving the vaccines. The patient was hospitalized and lab data included a beta-human chorionic gonadotropin test (unspecified), chest x-ray, complete blood cell count, "LMP", echocardiography, electrocardiogram, electroencephalography, head computed axial tomography, and white blood cell differential. At the time of this report, the patient's outcome was unknown. The original reporting source was not provided. No further information is available."
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Electroencephalogram, Full blood count, Pregnancy test, Syncope, White blood cell count
Clinical narrative: Initial information received on 07 June 2007 from another manufacturer, report# WAES0705USA05083. The initial reporter to this manufacturer had been the FDA, VAERS# not provided. Verbatim from the report: "Information has been received on request from the FDA under the Freedom of Information Act regarding a 12 year old female patient with a history of headaches, depression and systolic murmur, who on 29-MAR-2007 was vaccinated IM into the right arm with a first dose of Gardasil (Lot# 654535/0960F). Concomitant therapy given on 29-MAR-2007 IM into the left arm included a first dose of MENACTRA (Lot# U2061AA). On 29-MAR-2007, the patient collapsed 15 to 20 minutes after receiving the vaccines. The patient was hospitalized and lab data included a beta-human chorionic gonadotropin test (unspecified), chest x-ray, complete blood cell count, "LMP", echocardiography, electrocardiogram, electroencephalography, head computed axial tomography, and white blood cell differential. At the time of this report, the patient's outcome was unknown. The original reporting source was not provided. No further information is available."
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Blister, Chapped lips, Dehydration, Fluid replacement, Injection site erythema
Clinical narrative: Initial report received on 07 June 2007 from another manufacturer, report# WAES0705USA05087. The initial reporter to this manufacturer had been the FDA, VAERS# not provided. Verbatim from the report: "Information has been received on request from the FDA under the Freedom of information Act regarding a 16 year old female patient with no medical history or allergies, who on 07-MAR-2007 was vaccinated IM with a second dose of Gardasil. Concomitant suspect therapy given on 07-MAR-2007 included a dose varicella virus vaccine live (manufacturer unknown). Other concomitant therapy included MENACTRA and a dose of Dtap. On 11-MAR-2007, within a week one of the injection sites swelled and became painful and red. The doctor's office was notified of this reaction. Within two weeks of injections, both lips swelled for one day. Within 4 weeks of injection, lips cracked and by the fifth week after injection the patient was hospitalized for severe stomatitis. The patient has never suffered these symptoms before, nor has she seeked care for the problem prior to this. The patient became dehydrated and needed I.V. care. The patient had blister type lesions that started on the outside of the lips and continued to spread to the back of the throat. Diagnostic laboratory tests included blood culture and lip culture. The patient has improved greatly and should have a full recovery. The original reporting source was not provided. No further information is available." It was reported in the structured field of the report that all vaccines had been administered intramuscularly.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site pain, Injection site swelling, Lip swelling, Stomatitis
Clinical narrative: Initial report received on 07 June 2007 from another manufacturer, report# WAES0705USA05087. The initial reporter to this manufacturer had been the FDA, VAERS# not provided. Verbatim from the report: "Information has been received on request from the FDA under the Freedom of information Act regarding a 16 year old female patient with no medical history or allergies, who on 07-MAR-2007 was vaccinated IM with a second dose of Gardasil. Concomitant suspect therapy given on 07-MAR-2007 included a dose varicella virus vaccine live (manufacturer unknown). Other concomitant therapy included MENACTRA and a dose of Dtap. On 11-MAR-2007, within a week one of the injection sites swelled and became painful and red. The doctor's office was notified of this reaction. Within two weeks of injections, both lips swelled for one day. Within 4 weeks of injection, lips cracked and by the fifth week after injection the patient was hospitalized for severe stomatitis. The patient has never suffered these symptoms before, nor has she seeked care for the problem prior to this. The patient became dehydrated and needed I.V. care. The patient had blister type lesions that started on the outside of the lips and continued to spread to the back of the throat. Diagnostic laboratory tests included blood culture and lip culture. The patient has improved greatly and should have a full recovery. The original reporting source was not provided. No further information is available." It was reported in the structured field of the report that all vaccines had been administered intramuscularly.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Blood culture, Chapped lips, Culture, Dehydration, Injection site erythema
Clinical narrative: Initial report received on 07 June 2007 from another manufacturer, report# WAES0705USA05087. The initial reporter to this manufacturer had been the FDA, VAERS# not provided. Verbatim from the report: "Information has been received on request from the FDA under the Freedom of information Act regarding a 16 year old female patient with no medical history or allergies, who on 07-MAR-2007 was vaccinated IM with a second dose of Gardasil. Concomitant suspect therapy given on 07-MAR-2007 included a dose varicella virus vaccine live (manufacturer unknown). Other concomitant therapy included MENACTRA and a dose of Dtap. On 11-MAR-2007, within a week one of the injection sites swelled and became painful and red. The doctor's office was notified of this reaction. Within two weeks of injections, both lips swelled for one day. Within 4 weeks of injection, lips cracked and by the fifth week after injection the patient was hospitalized for severe stomatitis. The patient has never suffered these symptoms before, nor has she seeked care for the problem prior to this. The patient became dehydrated and needed I.V. care. The patient had blister type lesions that started on the outside of the lips and continued to spread to the back of the throat. Diagnostic laboratory tests included blood culture and lip culture. The patient has improved greatly and should have a full recovery. The original reporting source was not provided. No further information is available." It was reported in the structured field of the report that all vaccines had been administered intramuscularly.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site pain, Injection site swelling, Lip blister, Lip swelling, Stomatitis
Clinical narrative: Initial report received on 07 June 2007 from another manufacturer, report# WAES0705USA05087. The initial reporter to this manufacturer had been the FDA, VAERS# not provided. Verbatim from the report: "Information has been received on request from the FDA under the Freedom of information Act regarding a 16 year old female patient with no medical history or allergies, who on 07-MAR-2007 was vaccinated IM with a second dose of Gardasil. Concomitant suspect therapy given on 07-MAR-2007 included a dose varicella virus vaccine live (manufacturer unknown). Other concomitant therapy included MENACTRA and a dose of Dtap. On 11-MAR-2007, within a week one of the injection sites swelled and became painful and red. The doctor's office was notified of this reaction. Within two weeks of injections, both lips swelled for one day. Within 4 weeks of injection, lips cracked and by the fifth week after injection the patient was hospitalized for severe stomatitis. The patient has never suffered these symptoms before, nor has she seeked care for the problem prior to this. The patient became dehydrated and needed I.V. care. The patient had blister type lesions that started on the outside of the lips and continued to spread to the back of the throat. Diagnostic laboratory tests included blood culture and lip culture. The patient has improved greatly and should have a full recovery. The original reporting source was not provided. No further information is available." It was reported in the structured field of the report that all vaccines had been administered intramuscularly.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Initial report received on 07 June 2007 from another manufacturer, report# WAES0705USA05087. The initial reporter to this manufacturer had been the FDA, VAERS# not provided. Verbatim from the report: "Information has been received on request from the FDA under the Freedom of information Act regarding a 16 year old female patient with no medical history or allergies, who on 07-MAR-2007 was vaccinated IM with a second dose of Gardasil. Concomitant suspect therapy given on 07-MAR-2007 included a dose varicella virus vaccine live (manufacturer unknown). Other concomitant therapy included MENACTRA and a dose of Dtap. On 11-MAR-2007, within a week one of the injection sites swelled and became painful and red. The doctor's office was notified of this reaction. Within two weeks of injections, both lips swelled for one day. Within 4 weeks of injection, lips cracked and by the fifth week after injection the patient was hospitalized for severe stomatitis. The patient has never suffered these symptoms before, nor has she seeked care for the problem prior to this. The patient became dehydrated and needed I.V. care. The patient had blister type lesions that started on the outside of the lips and continued to spread to the back of the throat. Diagnostic laboratory tests included blood culture and lip culture. The patient has improved greatly and should have a full recovery. The original reporting source was not provided. No further information is available." It was reported in the structured field of the report that all vaccines had been administered intramuscularly.
Age: 42.0
Sex: M
Vaccine: DPP, HEPAB, IPV, HEPAB, IPV, TD, DT, HEPAB, IPV, HEPAB, IPV, TD, HEPAB, IPV, TD
Symptoms: Acoustic stimulation tests, Deafness, Vertigo
Clinical narrative: Initial report received from a nurse on 04 June 2007. A 42 year old male patient experienced sudden onset of complete hearing loss in the left ear, with vertigo and nausea and had a slight temperature, after he received Decavac (lot number U1982DA) intramuscularly in the right deltoid, IPOL (lot number Z0872-2) intramuscularly in the left deltoid and Twinrix (lot number AHABB036AA) intramuscularly in the left deltoid on 11 May 2007. He contacted his primary physician and was prescribed Ibuprofen and Benadryl. On 14 may 2007, he was evaluated by an ENT and diagnosed with sudden hearing loss syndrome. He was prescribed prednisone. Blood work was done and results showed increased WBCs. MRI was within normal limits. He did not have any medical history or illness at the time of the vaccinations and was not on any medications. At the time of the report, he had not recovered.
Age: 42.0
Sex: M
Vaccine: DPP, HEPAB, IPV, HEPAB, IPV, TD, DT, HEPAB, IPV, HEPAB, IPV, TD, HEPAB, IPV, TD
Symptoms: Blood test, Body temperature increased, Nausea, Nuclear magnetic resonance imaging normal, Sudden hearing loss
Clinical narrative: Initial report received from a nurse on 04 June 2007. A 42 year old male patient experienced sudden onset of complete hearing loss in the left ear, with vertigo and nausea and had a slight temperature, after he received Decavac (lot number U1982DA) intramuscularly in the right deltoid, IPOL (lot number Z0872-2) intramuscularly in the left deltoid and Twinrix (lot number AHABB036AA) intramuscularly in the left deltoid on 11 May 2007. He contacted his primary physician and was prescribed Ibuprofen and Benadryl. On 14 may 2007, he was evaluated by an ENT and diagnosed with sudden hearing loss syndrome. He was prescribed prednisone. Blood work was done and results showed increased WBCs. MRI was within normal limits. He did not have any medical history or illness at the time of the vaccinations and was not on any medications. At the time of the report, he had not recovered.
Age: 42.0
Sex: M
Vaccine: DPP, HEPAB, IPV, HEPAB, IPV, TD, DT, HEPAB, IPV, HEPAB, IPV, TD, HEPAB, IPV, TD
Symptoms: Vertigo, White blood cell count increased
Clinical narrative: Initial report received from a nurse on 04 June 2007. A 42 year old male patient experienced sudden onset of complete hearing loss in the left ear, with vertigo and nausea and had a slight temperature, after he received Decavac (lot number U1982DA) intramuscularly in the right deltoid, IPOL (lot number Z0872-2) intramuscularly in the left deltoid and Twinrix (lot number AHABB036AA) intramuscularly in the left deltoid on 11 May 2007. He contacted his primary physician and was prescribed Ibuprofen and Benadryl. On 14 may 2007, he was evaluated by an ENT and diagnosed with sudden hearing loss syndrome. He was prescribed prednisone. Blood work was done and results showed increased WBCs. MRI was within normal limits. He did not have any medical history or illness at the time of the vaccinations and was not on any medications. At the time of the report, he had not recovered.
Age: 42.0
Sex: M
Vaccine: DPP, HEPAB, IPV, HEPAB, IPV, TD, DT, HEPAB, IPV, HEPAB, IPV, TD, HEPAB, IPV, TD
Symptoms: Blood test, Nausea, Nuclear magnetic resonance imaging normal, Pyrexia, Sudden hearing loss
Clinical narrative: Initial report received from a nurse on 04 June 2007. A 42 year old male patient experienced sudden onset of complete hearing loss in the left ear, with vertigo and nausea and had a slight temperature, after he received Decavac (lot number U1982DA) intramuscularly in the right deltoid, IPOL (lot number Z0872-2) intramuscularly in the left deltoid and Twinrix (lot number AHABB036AA) intramuscularly in the left deltoid on 11 May 2007. He contacted his primary physician and was prescribed Ibuprofen and Benadryl. On 14 may 2007, he was evaluated by an ENT and diagnosed with sudden hearing loss syndrome. He was prescribed prednisone. Blood work was done and results showed increased WBCs. MRI was within normal limits. He did not have any medical history or illness at the time of the vaccinations and was not on any medications. At the time of the report, he had not recovered.
Age: 42.0
Sex: M
Vaccine: DPP, HEPAB, IPV, HEPAB, IPV, TD, DT, HEPAB, IPV, HEPAB, IPV, TD, HEPAB, IPV, TD
Symptoms: Deafness
Clinical narrative: Initial report received from a nurse on 04 June 2007. A 42 year old male patient experienced sudden onset of complete hearing loss in the left ear, with vertigo and nausea and had a slight temperature, after he received Decavac (lot number U1982DA) intramuscularly in the right deltoid, IPOL (lot number Z0872-2) intramuscularly in the left deltoid and Twinrix (lot number AHABB036AA) intramuscularly in the left deltoid on 11 May 2007. He contacted his primary physician and was prescribed Ibuprofen and Benadryl. On 14 may 2007, he was evaluated by an ENT and diagnosed with sudden hearing loss syndrome. He was prescribed prednisone. Blood work was done and results showed increased WBCs. MRI was within normal limits. He did not have any medical history or illness at the time of the vaccinations and was not on any medications. At the time of the report, he had not recovered.
Age: 42.0
Sex: M
Vaccine: DPP, HEPAB, IPV, HEPAB, IPV, TD, DT, HEPAB, IPV, HEPAB, IPV, TD, HEPAB, IPV, TD
Symptoms: Blood test, Deafness, Deafness unilateral, Nausea, Nuclear magnetic resonance imaging
Clinical narrative: Initial report received from a nurse on 04 June 2007. A 42 year old male patient experienced sudden onset of complete hearing loss in the left ear, with vertigo and nausea and had a slight temperature, after he received Decavac (lot number U1982DA) intramuscularly in the right deltoid, IPOL (lot number Z0872-2) intramuscularly in the left deltoid and Twinrix (lot number AHABB036AA) intramuscularly in the left deltoid on 11 May 2007. He contacted his primary physician and was prescribed Ibuprofen and Benadryl. On 14 may 2007, he was evaluated by an ENT and diagnosed with sudden hearing loss syndrome. He was prescribed prednisone. Blood work was done and results showed increased WBCs. MRI was within normal limits. He did not have any medical history or illness at the time of the vaccinations and was not on any medications. At the time of the report, he had not recovered.
Age: 42.0
Sex: M
Vaccine: DPP, HEPAB, IPV, HEPAB, IPV, TD, DT, HEPAB, IPV, HEPAB, IPV, TD, HEPAB, IPV, TD
Symptoms: Pyrexia, Sudden hearing loss, Vertigo
Clinical narrative: Initial report received from a nurse on 04 June 2007. A 42 year old male patient experienced sudden onset of complete hearing loss in the left ear, with vertigo and nausea and had a slight temperature, after he received Decavac (lot number U1982DA) intramuscularly in the right deltoid, IPOL (lot number Z0872-2) intramuscularly in the left deltoid and Twinrix (lot number AHABB036AA) intramuscularly in the left deltoid on 11 May 2007. He contacted his primary physician and was prescribed Ibuprofen and Benadryl. On 14 may 2007, he was evaluated by an ENT and diagnosed with sudden hearing loss syndrome. He was prescribed prednisone. Blood work was done and results showed increased WBCs. MRI was within normal limits. He did not have any medical history or illness at the time of the vaccinations and was not on any medications. At the time of the report, he had not recovered.
Age: 37.0
Sex: M
Vaccine: DPP, HEPAB, IPV, HEPAB, IPV, TD, DT, HEPAB, IPV, HEPAB, IPV, TD, HEPAB, IPV, TD
Symptoms: Acoustic stimulation tests, Deafness, Vertigo
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received on 05 June 2007 from a nurse. A 37-year-old male patient with unknown medical history, had received from travel purposes, a right deltoid, intramuscular injection of Decavac, lot number U1927DA; a left deltoid, intramuscular injection of IPOL, lot number Z0872-2; and a left deltoid, intramuscular injection of Twinrix, lot number AHABB036AA, on 11 May 2007. on 13 May 2007, i.e. two days after receiving the vaccinations, the patient experienced sudden onset of unilateral hearing loss (it was not identified which ear. He also complained of vertigo, nausea and a slight temperature. However, the subject did not obtain a temperature reading. The patient called his physician that day and was started on Ibuprofen and Benadryl, and was referred to another physician. The following day, the patient was evaluated by the other physician and diagnosed with sudden onset unilateral hearing loss. The patient was prescribed Prednisone. Blood work and an MRI were performed but the reporter did not have the results of the tests. The patient does have a significant family history of an aunt who experienced sudden onset of unilateral hearing loss at age 60 years (etiology unknown). At the time of this report the patient had not recovered.
Age: 37.0
Sex: M
Vaccine: DPP, HEPAB, IPV, HEPAB, IPV, TD, DT, HEPAB, IPV, HEPAB, IPV, TD, HEPAB, IPV, TD
Symptoms: Blood test, Body temperature increased, Nausea, Nuclear magnetic resonance imaging normal, Sudden hearing loss
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received on 05 June 2007 from a nurse. A 37-year-old male patient with unknown medical history, had received from travel purposes, a right deltoid, intramuscular injection of Decavac, lot number U1927DA; a left deltoid, intramuscular injection of IPOL, lot number Z0872-2; and a left deltoid, intramuscular injection of Twinrix, lot number AHABB036AA, on 11 May 2007. on 13 May 2007, i.e. two days after receiving the vaccinations, the patient experienced sudden onset of unilateral hearing loss (it was not identified which ear. He also complained of vertigo, nausea and a slight temperature. However, the subject did not obtain a temperature reading. The patient called his physician that day and was started on Ibuprofen and Benadryl, and was referred to another physician. The following day, the patient was evaluated by the other physician and diagnosed with sudden onset unilateral hearing loss. The patient was prescribed Prednisone. Blood work and an MRI were performed but the reporter did not have the results of the tests. The patient does have a significant family history of an aunt who experienced sudden onset of unilateral hearing loss at age 60 years (etiology unknown). At the time of this report the patient had not recovered.
Age: 37.0
Sex: M
Vaccine: DPP, HEPAB, IPV, HEPAB, IPV, TD, DT, HEPAB, IPV, HEPAB, IPV, TD, HEPAB, IPV, TD
Symptoms: Vertigo, White blood cell count increased
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received on 05 June 2007 from a nurse. A 37-year-old male patient with unknown medical history, had received from travel purposes, a right deltoid, intramuscular injection of Decavac, lot number U1927DA; a left deltoid, intramuscular injection of IPOL, lot number Z0872-2; and a left deltoid, intramuscular injection of Twinrix, lot number AHABB036AA, on 11 May 2007. on 13 May 2007, i.e. two days after receiving the vaccinations, the patient experienced sudden onset of unilateral hearing loss (it was not identified which ear. He also complained of vertigo, nausea and a slight temperature. However, the subject did not obtain a temperature reading. The patient called his physician that day and was started on Ibuprofen and Benadryl, and was referred to another physician. The following day, the patient was evaluated by the other physician and diagnosed with sudden onset unilateral hearing loss. The patient was prescribed Prednisone. Blood work and an MRI were performed but the reporter did not have the results of the tests. The patient does have a significant family history of an aunt who experienced sudden onset of unilateral hearing loss at age 60 years (etiology unknown). At the time of this report the patient had not recovered.
Age: 37.0
Sex: M
Vaccine: DPP, HEPAB, IPV, HEPAB, IPV, TD, DT, HEPAB, IPV, HEPAB, IPV, TD, HEPAB, IPV, TD
Symptoms: Blood test, Nausea, Nuclear magnetic resonance imaging normal, Pyrexia, Sudden hearing loss
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received on 05 June 2007 from a nurse. A 37-year-old male patient with unknown medical history, had received from travel purposes, a right deltoid, intramuscular injection of Decavac, lot number U1927DA; a left deltoid, intramuscular injection of IPOL, lot number Z0872-2; and a left deltoid, intramuscular injection of Twinrix, lot number AHABB036AA, on 11 May 2007. on 13 May 2007, i.e. two days after receiving the vaccinations, the patient experienced sudden onset of unilateral hearing loss (it was not identified which ear. He also complained of vertigo, nausea and a slight temperature. However, the subject did not obtain a temperature reading. The patient called his physician that day and was started on Ibuprofen and Benadryl, and was referred to another physician. The following day, the patient was evaluated by the other physician and diagnosed with sudden onset unilateral hearing loss. The patient was prescribed Prednisone. Blood work and an MRI were performed but the reporter did not have the results of the tests. The patient does have a significant family history of an aunt who experienced sudden onset of unilateral hearing loss at age 60 years (etiology unknown). At the time of this report the patient had not recovered.
Age: 37.0
Sex: M
Vaccine: DPP, HEPAB, IPV, HEPAB, IPV, TD, DT, HEPAB, IPV, HEPAB, IPV, TD, HEPAB, IPV, TD
Symptoms: Deafness
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received on 05 June 2007 from a nurse. A 37-year-old male patient with unknown medical history, had received from travel purposes, a right deltoid, intramuscular injection of Decavac, lot number U1927DA; a left deltoid, intramuscular injection of IPOL, lot number Z0872-2; and a left deltoid, intramuscular injection of Twinrix, lot number AHABB036AA, on 11 May 2007. on 13 May 2007, i.e. two days after receiving the vaccinations, the patient experienced sudden onset of unilateral hearing loss (it was not identified which ear. He also complained of vertigo, nausea and a slight temperature. However, the subject did not obtain a temperature reading. The patient called his physician that day and was started on Ibuprofen and Benadryl, and was referred to another physician. The following day, the patient was evaluated by the other physician and diagnosed with sudden onset unilateral hearing loss. The patient was prescribed Prednisone. Blood work and an MRI were performed but the reporter did not have the results of the tests. The patient does have a significant family history of an aunt who experienced sudden onset of unilateral hearing loss at age 60 years (etiology unknown). At the time of this report the patient had not recovered.
Age: 37.0
Sex: M
Vaccine: DPP, HEPAB, IPV, HEPAB, IPV, TD, DT, HEPAB, IPV, HEPAB, IPV, TD, HEPAB, IPV, TD
Symptoms: Blood test, Deafness, Deafness unilateral, Nausea, Nuclear magnetic resonance imaging
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received on 05 June 2007 from a nurse. A 37-year-old male patient with unknown medical history, had received from travel purposes, a right deltoid, intramuscular injection of Decavac, lot number U1927DA; a left deltoid, intramuscular injection of IPOL, lot number Z0872-2; and a left deltoid, intramuscular injection of Twinrix, lot number AHABB036AA, on 11 May 2007. on 13 May 2007, i.e. two days after receiving the vaccinations, the patient experienced sudden onset of unilateral hearing loss (it was not identified which ear. He also complained of vertigo, nausea and a slight temperature. However, the subject did not obtain a temperature reading. The patient called his physician that day and was started on Ibuprofen and Benadryl, and was referred to another physician. The following day, the patient was evaluated by the other physician and diagnosed with sudden onset unilateral hearing loss. The patient was prescribed Prednisone. Blood work and an MRI were performed but the reporter did not have the results of the tests. The patient does have a significant family history of an aunt who experienced sudden onset of unilateral hearing loss at age 60 years (etiology unknown). At the time of this report the patient had not recovered.
Age: 37.0
Sex: M
Vaccine: DPP, HEPAB, IPV, HEPAB, IPV, TD, DT, HEPAB, IPV, HEPAB, IPV, TD, HEPAB, IPV, TD
Symptoms: Pyrexia, Sudden hearing loss, Vertigo
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received on 05 June 2007 from a nurse. A 37-year-old male patient with unknown medical history, had received from travel purposes, a right deltoid, intramuscular injection of Decavac, lot number U1927DA; a left deltoid, intramuscular injection of IPOL, lot number Z0872-2; and a left deltoid, intramuscular injection of Twinrix, lot number AHABB036AA, on 11 May 2007. on 13 May 2007, i.e. two days after receiving the vaccinations, the patient experienced sudden onset of unilateral hearing loss (it was not identified which ear. He also complained of vertigo, nausea and a slight temperature. However, the subject did not obtain a temperature reading. The patient called his physician that day and was started on Ibuprofen and Benadryl, and was referred to another physician. The following day, the patient was evaluated by the other physician and diagnosed with sudden onset unilateral hearing loss. The patient was prescribed Prednisone. Blood work and an MRI were performed but the reporter did not have the results of the tests. The patient does have a significant family history of an aunt who experienced sudden onset of unilateral hearing loss at age 60 years (etiology unknown). At the time of this report the patient had not recovered.
Age: 53.0
Sex: F
Vaccine: HEPAB, TYP
Symptoms: Immediate post-injection reaction, Pruritus
Clinical narrative: On Oct. 3, 1990, I received a required shot of Gamma Globulin which was required at the time for a trip. Upon receiving the shot, I immediately began itching.  This has lasted now for 17 years with no let up.  I am still breaking out and itching constantly.  I have been to numerous dermatologists and even recently had an extensive heavy metal toxicity test which was normal. I can no longer wear skirts as I am ashamed of the sores and marks on my legs.  My back keeps breaking out in several places as do my thighs .  My whole body except for my face is involved. The sores never go away once they come. I wish to know if any one else who received this batch had a reaction.  The manufacturer was Connaught and the batch 3 49281-915.  There is also on my card, OG11134.   This was administered at Health Center. Any help or direction you can give me would be greatly appreciated.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Pain, weakness of arm
Age: 49.0
Sex: M
Vaccine: HEP
Symptoms: Balance disorder, Dizziness, Dysgeusia, Flushing, Pharyngeal hypoaesthesia
Clinical narrative: Dose #1 Hep B vaccine given. After approx 1 minute recipient complained of metallic taste in mouth. Within 5 minutes he c/o feeling dizzy. Unsteady on feet; face flushed. Small amt vomiting. C/O numbness at back of throat. VS 142/90, P 72 T 98.5 o2 sat 99. Taken to ER/ambulance.
Age: 49.0
Sex: M
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Dose #1 Hep B vaccine given. After approx 1 minute recipient complained of metallic taste in mouth. Within 5 minutes he c/o feeling dizzy. Unsteady on feet; face flushed. Small amt vomiting. C/O numbness at back of throat. VS 142/90, P 72 T 98.5 o2 sat 99. Taken to ER/ambulance.
Age: 0.5
Sex: M
Vaccine: DTAP, IPV, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Anorexia, Barium double contrast, Barium enema, Diarrhoea, Gastrointestinal disorder
Clinical narrative: Information has been received from a physician concerning a 6 month old male who on approximately 05-JUN-2007 was vaccinated with third dose of Rotateq (LOT# 654248/0577F). Concomitant vaccines included DTaP (also reported as "Betap") and poliovirus vaccine. On 05-JUN-2007, the physician reported that the patient experienced "fussiness and wasn't eating". The parents took him to the emergency room (ER) and he was released with a diagnoses of "some gastrointestinal problems". The patient was also vomiting and had diarrhea and was taken to the pediactrics' office the next day and the physician checked him and sent him home. On 06-JUN-2007, the patient was still vomiting and had diarrhea and was again taken to the ER and was admitted with a diagnosis of "intussusception", he had an 'air contrast enema" done twice and "it helped him". The patient was discharged 24 hours later on 07-JUN-2007. The patient's outcome was reported as recovered. The physician considered intussusception to be an other important medical event. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAP, IPV, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Intussusception, Irritability, Vomiting, X-ray
Clinical narrative: Information has been received from a physician concerning a 6 month old male who on approximately 05-JUN-2007 was vaccinated with third dose of Rotateq (LOT# 654248/0577F). Concomitant vaccines included DTaP (also reported as "Betap") and poliovirus vaccine. On 05-JUN-2007, the physician reported that the patient experienced "fussiness and wasn't eating". The parents took him to the emergency room (ER) and he was released with a diagnoses of "some gastrointestinal problems". The patient was also vomiting and had diarrhea and was taken to the pediactrics' office the next day and the physician checked him and sent him home. On 06-JUN-2007, the patient was still vomiting and had diarrhea and was again taken to the ER and was admitted with a diagnosis of "intussusception", he had an 'air contrast enema" done twice and "it helped him". The patient was discharged 24 hours later on 07-JUN-2007. The patient's outcome was reported as recovered. The physician considered intussusception to be an other important medical event. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAP, IPV, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Abdominal distension, Barium double contrast, Diarrhoea, Intussusception, Irritability
Clinical narrative: Information has been received from a physician concerning a 6 month old male who on approximately 05-JUN-2007 was vaccinated with third dose of Rotateq (LOT# 654248/0577F). Concomitant vaccines included DTaP (also reported as "Betap") and poliovirus vaccine. On 05-JUN-2007, the physician reported that the patient experienced "fussiness and wasn't eating". The parents took him to the emergency room (ER) and he was released with a diagnoses of "some gastrointestinal problems". The patient was also vomiting and had diarrhea and was taken to the pediactrics' office the next day and the physician checked him and sent him home. On 06-JUN-2007, the patient was still vomiting and had diarrhea and was again taken to the ER and was admitted with a diagnosis of "intussusception", he had an 'air contrast enema" done twice and "it helped him". The patient was discharged 24 hours later on 07-JUN-2007. The patient's outcome was reported as recovered. The physician considered intussusception to be an other important medical event. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAP, IPV, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 6 month old male who on approximately 05-JUN-2007 was vaccinated with third dose of Rotateq (LOT# 654248/0577F). Concomitant vaccines included DTaP (also reported as "Betap") and poliovirus vaccine. On 05-JUN-2007, the physician reported that the patient experienced "fussiness and wasn't eating". The parents took him to the emergency room (ER) and he was released with a diagnoses of "some gastrointestinal problems". The patient was also vomiting and had diarrhea and was taken to the pediactrics' office the next day and the physician checked him and sent him home. On 06-JUN-2007, the patient was still vomiting and had diarrhea and was again taken to the ER and was admitted with a diagnosis of "intussusception", he had an 'air contrast enema" done twice and "it helped him". The patient was discharged 24 hours later on 07-JUN-2007. The patient's outcome was reported as recovered. The physician considered intussusception to be an other important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Syncope
Clinical narrative: Information has been received from a registered nurse concerning her 17 year old daughter with no relevant medical history reported who on 11-JUN-2007 was vaccinated intramuscularly with a 0.5 ml dose of Gardasil. There was no concomitant medication. On 11-JUN-2007, the patient fainted and "exhibited seizure like behavior" after receiving Gardasil. The patient sought unspecified medical attention. Subsequently, the patient recovered on 11-JUN-2007. Upon internal review, the patient's convulsion was considered an other important medical event. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female with no relevant medical history who on 19-FEB-2007 was vaccinated intramuscularly with a 0.5 mL first dose of Gardasil (lot 653735/0688F). Concomitant therapy included Ortho Tri-Cyclen Lo. Subsequently, she became pregnant. Date of LMP was 04-APR-2007. The patient subsequently miscarried. The patient was seen in the emergency room on 14-MAY-2007 for the miscarriage. She was not admitted to the hospital. The patient called the office on 17-MAY-2007 to notify the physician of the miscarriage, but had not returned to the office for follow-up visits. Upon internal review, the patient's spontaneous abortion was considered an other important medical event. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Immediate post-injection reaction
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 26 year old female patient with Crohn's disease and a history of "passing out" when blood is drawn, who on 06-JUN-2007 was vaccinated with the first dose of Gardasil (Lot # not provided). Concomitant therapy included unspecified medication for Crohn's disease and hormonal contraceptives (unspecified). On 06-JUN-2007, "within 5 minutes" after she had received the vaccination, the patient had a seizure. The physician then confirmed that the patient was completely "lucid" and conscious, and was oriented to the time, the date and her name, however it was not specified whether the patient had recovered from the event. The physician, "does not believe" the seizure was related to therapy with Gardasil. The patient sought unspecified medical attention. Upon internal review, had a seizure was considered to be serious as an other important medical event. Additional information has been requested.
Sex: U
Vaccine: DTAP, IPV, MMRV
Symptoms: Incorrect route of drug administration, Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a pediatric patient with no allergies, who on 29-MAY-2007 was vaccinated intramuscularly with a 0.5 milliliter dose of ProQuad (lot# 656312/0297U). Concomitant vaccinations included a dose of DTaP (unspecified) and a dose of poliovirus vaccine which were given in an alternate site. Subsequently, on an unspecified date following vaccination, the patient experienced nausea, fever and injection site swelling with redness and warmth, possibly cellulitis. Unspecified medical treatment was sought. It is reported that it is possible that the patient was treated with antibiotics. No laboratory or diagnostic tests were performed. The outcome is reported as recovering. No product quality complaint was involved. The reporter considered the patient's adverse experienced to be important medical events. Additional information has been requested.
Sex: U
Vaccine: DTAP, IPV, MMRV
Symptoms: Nausea, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a pediatric patient with no allergies, who on 29-MAY-2007 was vaccinated intramuscularly with a 0.5 milliliter dose of ProQuad (lot# 656312/0297U). Concomitant vaccinations included a dose of DTaP (unspecified) and a dose of poliovirus vaccine which were given in an alternate site. Subsequently, on an unspecified date following vaccination, the patient experienced nausea, fever and injection site swelling with redness and warmth, possibly cellulitis. Unspecified medical treatment was sought. It is reported that it is possible that the patient was treated with antibiotics. No laboratory or diagnostic tests were performed. The outcome is reported as recovering. No product quality complaint was involved. The reporter considered the patient's adverse experienced to be important medical events. Additional information has been requested.