chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: ANTH, ANTH, ANTH, SMALL
Symptoms: Frequent bowel movements, Gastrointestinal disorder, Haematochezia, Haemorrhoids, Headache
Clinical narrative: Reported on 1st visit to Neurology 9/9/10 headaches since/ s/p 2 Anthrax injections 2 yrs. prior (2007) - headaches 3-5 a month & up to 10 a month. Currently on MAXALT 10mg.
Age: 47.0
Sex: F
Vaccine: ANTH, ANTH, ANTH, SMALL
Symptoms: Hypertension, Immediate post-injection reaction, Incontinence, Injection site cellulitis, Injection site swelling
Clinical narrative: Reported on 1st visit to Neurology 9/9/10 headaches since/ s/p 2 Anthrax injections 2 yrs. prior (2007) - headaches 3-5 a month & up to 10 a month. Currently on MAXALT 10mg.
Age: 47.0
Sex: F
Vaccine: ANTH, ANTH, ANTH, SMALL
Symptoms: Laboratory test normal, Migraine, Multiple allergies, Muscle twitching, Neurological examination
Clinical narrative: Reported on 1st visit to Neurology 9/9/10 headaches since/ s/p 2 Anthrax injections 2 yrs. prior (2007) - headaches 3-5 a month & up to 10 a month. Currently on MAXALT 10mg.
Age: 47.0
Sex: F
Vaccine: ANTH, ANTH, ANTH, SMALL
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity, Palpitations, Parasitic test, Photosensitivity reaction
Clinical narrative: Reported on 1st visit to Neurology 9/9/10 headaches since/ s/p 2 Anthrax injections 2 yrs. prior (2007) - headaches 3-5 a month & up to 10 a month. Currently on MAXALT 10mg.
Age: 47.0
Sex: F
Vaccine: ANTH, ANTH, ANTH, SMALL
Symptoms: Pyrexia, Restless legs syndrome, Sleep study, Somnolence, Tinnitus
Clinical narrative: Reported on 1st visit to Neurology 9/9/10 headaches since/ s/p 2 Anthrax injections 2 yrs. prior (2007) - headaches 3-5 a month & up to 10 a month. Currently on MAXALT 10mg.
Age: 47.0
Sex: F
Vaccine: ANTH, ANTH, ANTH, SMALL
Symptoms: Vestibular disorder, Vestibular function test, Weight decreased
Clinical narrative: Reported on 1st visit to Neurology 9/9/10 headaches since/ s/p 2 Anthrax injections 2 yrs. prior (2007) - headaches 3-5 a month & up to 10 a month. Currently on MAXALT 10mg.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Adverse event, Amnesia, Computerised tomogram, Dehydration, Diarrhoea
Clinical narrative: Initial report was received 02 March 2010 from a consumer who is the patient's father. A 16-year-old male patient had received a left deltoid intramuscular injection of MENACTRA, lot number U2930AA on 20 July 2009 at 7:17pm and five days later, he developed vomiting and diarrhea. The following morning he experienced a grand mal seizure. The event required an emergency room visit and corrective treatments consisted of DILANTIN. Diagnostic and laboratory data were unknown. The patient had a past history of a sulfa allergy and he had no illness at the time of vaccination. The patient subsequently experienced a similar event after receiving a dose of H1N1 (manufacturer sanofi pasteur, lot number UP001AA) on 30 October 2009 which has been captured in case number 2010-01335. According to the reporter, the patient had been evaluated by a neurologist and at the time of the report, he had not recovered. Follow-up information was received from the health care professional on 15 April 2010, which noted that the reporter had reviewed the case and had no further information to provide. No relevant additional information was obtained for the adverse event. This follow-up information will not be submitted as a 15-day follow-up report to the Health Authorities. Follow-up information was received from a health care professional on 29 July 2010 provided medical records. The patient developed nausea, vomiting and diarrhea and became dehydrated and while in a cabin on vacation at 9000 feet. He developed what sounds to have been a good seizure. He was amnestic to the event. He dislocated his left shoulder (subluxation) which was immobilized in a sling. He had a second seizure while in the hospital. A computed tomography (CAT) scan was done (results not provided) and an electroencephalogram which revealed left temporal irritable focus as well as a sense of some frontal predominant "FADA" frequency discharges. This would suggest an underlying predisposition to seizures. A magnetic resonance imaging (MRI) was performed on 10 August 2009 which was normal and there was a lesion in the left anterior temporal lobe that actually correlated fairly well with one of the abnormalities seen on the electroencephalogram. It was not clear what this finding represented but did not look particularly malignant. The patient denied having anything that was aura like or seizure like in the past. He denied any head injury or other predisposing factors. The patient's medical history included delayed speech development as a child and no history of seizures or febrile seizures. The patient's maternal side of the family was noteworthy for maternal uncle with seizures and a maternal great-grandfather with seizures. The patient remains on DILANTIN capsules 100 milligrams (mg) three times a day. The outcome remained not recovered. This patient experienced another serious adverse event which has been captured in case number 2010-01335. Documents held by sender: Medical records.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Electroencephalogram abnormal, Grand mal convulsion, Joint dislocation, Nausea, Nervous system disorder
Clinical narrative: Initial report was received 02 March 2010 from a consumer who is the patient's father. A 16-year-old male patient had received a left deltoid intramuscular injection of MENACTRA, lot number U2930AA on 20 July 2009 at 7:17pm and five days later, he developed vomiting and diarrhea. The following morning he experienced a grand mal seizure. The event required an emergency room visit and corrective treatments consisted of DILANTIN. Diagnostic and laboratory data were unknown. The patient had a past history of a sulfa allergy and he had no illness at the time of vaccination. The patient subsequently experienced a similar event after receiving a dose of H1N1 (manufacturer sanofi pasteur, lot number UP001AA) on 30 October 2009 which has been captured in case number 2010-01335. According to the reporter, the patient had been evaluated by a neurologist and at the time of the report, he had not recovered. Follow-up information was received from the health care professional on 15 April 2010, which noted that the reporter had reviewed the case and had no further information to provide. No relevant additional information was obtained for the adverse event. This follow-up information will not be submitted as a 15-day follow-up report to the Health Authorities. Follow-up information was received from a health care professional on 29 July 2010 provided medical records. The patient developed nausea, vomiting and diarrhea and became dehydrated and while in a cabin on vacation at 9000 feet. He developed what sounds to have been a good seizure. He was amnestic to the event. He dislocated his left shoulder (subluxation) which was immobilized in a sling. He had a second seizure while in the hospital. A computed tomography (CAT) scan was done (results not provided) and an electroencephalogram which revealed left temporal irritable focus as well as a sense of some frontal predominant "FADA" frequency discharges. This would suggest an underlying predisposition to seizures. A magnetic resonance imaging (MRI) was performed on 10 August 2009 which was normal and there was a lesion in the left anterior temporal lobe that actually correlated fairly well with one of the abnormalities seen on the electroencephalogram. It was not clear what this finding represented but did not look particularly malignant. The patient denied having anything that was aura like or seizure like in the past. He denied any head injury or other predisposing factors. The patient's medical history included delayed speech development as a child and no history of seizures or febrile seizures. The patient's maternal side of the family was noteworthy for maternal uncle with seizures and a maternal great-grandfather with seizures. The patient remains on DILANTIN capsules 100 milligrams (mg) three times a day. The outcome remained not recovered. This patient experienced another serious adverse event which has been captured in case number 2010-01335. Documents held by sender: Medical records.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Nuclear magnetic resonance imaging normal, Vomiting
Clinical narrative: Initial report was received 02 March 2010 from a consumer who is the patient's father. A 16-year-old male patient had received a left deltoid intramuscular injection of MENACTRA, lot number U2930AA on 20 July 2009 at 7:17pm and five days later, he developed vomiting and diarrhea. The following morning he experienced a grand mal seizure. The event required an emergency room visit and corrective treatments consisted of DILANTIN. Diagnostic and laboratory data were unknown. The patient had a past history of a sulfa allergy and he had no illness at the time of vaccination. The patient subsequently experienced a similar event after receiving a dose of H1N1 (manufacturer sanofi pasteur, lot number UP001AA) on 30 October 2009 which has been captured in case number 2010-01335. According to the reporter, the patient had been evaluated by a neurologist and at the time of the report, he had not recovered. Follow-up information was received from the health care professional on 15 April 2010, which noted that the reporter had reviewed the case and had no further information to provide. No relevant additional information was obtained for the adverse event. This follow-up information will not be submitted as a 15-day follow-up report to the Health Authorities. Follow-up information was received from a health care professional on 29 July 2010 provided medical records. The patient developed nausea, vomiting and diarrhea and became dehydrated and while in a cabin on vacation at 9000 feet. He developed what sounds to have been a good seizure. He was amnestic to the event. He dislocated his left shoulder (subluxation) which was immobilized in a sling. He had a second seizure while in the hospital. A computed tomography (CAT) scan was done (results not provided) and an electroencephalogram which revealed left temporal irritable focus as well as a sense of some frontal predominant "FADA" frequency discharges. This would suggest an underlying predisposition to seizures. A magnetic resonance imaging (MRI) was performed on 10 August 2009 which was normal and there was a lesion in the left anterior temporal lobe that actually correlated fairly well with one of the abnormalities seen on the electroencephalogram. It was not clear what this finding represented but did not look particularly malignant. The patient denied having anything that was aura like or seizure like in the past. He denied any head injury or other predisposing factors. The patient's medical history included delayed speech development as a child and no history of seizures or febrile seizures. The patient's maternal side of the family was noteworthy for maternal uncle with seizures and a maternal great-grandfather with seizures. The patient remains on DILANTIN capsules 100 milligrams (mg) three times a day. The outcome remained not recovered. This patient experienced another serious adverse event which has been captured in case number 2010-01335. Documents held by sender: Medical records.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Abasia, Aphasia, Arthralgia, Delirium, Dizziness
Clinical narrative: Initial report received from another manufacturer on 20 April 2010, under reference number WAES 1004USA00917 (VAERS number 370371).  The following narrative is verbatim from that report: "This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act.  A mother reported that she brought her 16 year old daughter to hospital for "immunizations".  It was reported that her 16 year old daughter with allergies to red dye and codeine who was given the first dose of GARDASIL (lot number 663451/0216Y) into right arm, the first dose of MENACTRA (lot number U3015AA, MFR. Sanofi Pasteur) and the first dose of HAVRIX (lot number AHAVB312AA, MFR. GSK) into her left arm at about 5 pm on Tuesday 29-SEP-2009.  The mother commented "they talked to me to getting the meningitis one".  She said that the daughter got "dizzy" right away and had commented that she felt the meningitis shot "in elbow".  The mom reported that her daughter said her knees hurt on the way home and was rubbing her knees and legs in the car.  The mother took her daughter to the emergency room at around 9pm.  She said that her daughter was "delirious", she "couldn't walk or talk", and her "eyes were rolling back in her head".  The mom denied fever, respiratory distress or seizure activity in her daughter at that time.  The patient was admitted to hospital on 29-SEP-2009 and kept for 24 hours while "tests" were run.  The mother stated that the doctor was called in "consult" and that her daughter's MRI showed "fluid in the brain".  Her symptomology resolved spontaneously according to her mother, "going backwards" with the last symptoms resolving first and finally the pain in legs, knees, and her arm resolving.  The mother said that the doctor told her this could only happen if the meningitis had been given "directIV".  At this time the mother was mainly concerned because her daughter's arm bled and she didn't know if that meant the shot went into her vein or not.  It was reassured that the bleeding from the injection site after an immunization was not uncommon and did not mean that the vaccine accessed the vein.  The listing indicated that one or more of the events required hospitalization.  No further information is available".  "This was originally reported by the patient's mother.  The VAER ID number is 370371".  05 January 2011: A corrective version has been created in order to change the case to "not medically confirmed", as the event was originally reported by the patient's parent, who was not a health care professional.  No new relevant medical information has been added to the case.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Gaze palsy, Hydrocephalus, Immediate post-injection reaction, Injection site haemorrhage, Laboratory test
Clinical narrative: Initial report received from another manufacturer on 20 April 2010, under reference number WAES 1004USA00917 (VAERS number 370371).  The following narrative is verbatim from that report: "This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act.  A mother reported that she brought her 16 year old daughter to hospital for "immunizations".  It was reported that her 16 year old daughter with allergies to red dye and codeine who was given the first dose of GARDASIL (lot number 663451/0216Y) into right arm, the first dose of MENACTRA (lot number U3015AA, MFR. Sanofi Pasteur) and the first dose of HAVRIX (lot number AHAVB312AA, MFR. GSK) into her left arm at about 5 pm on Tuesday 29-SEP-2009.  The mother commented "they talked to me to getting the meningitis one".  She said that the daughter got "dizzy" right away and had commented that she felt the meningitis shot "in elbow".  The mom reported that her daughter said her knees hurt on the way home and was rubbing her knees and legs in the car.  The mother took her daughter to the emergency room at around 9pm.  She said that her daughter was "delirious", she "couldn't walk or talk", and her "eyes were rolling back in her head".  The mom denied fever, respiratory distress or seizure activity in her daughter at that time.  The patient was admitted to hospital on 29-SEP-2009 and kept for 24 hours while "tests" were run.  The mother stated that the doctor was called in "consult" and that her daughter's MRI showed "fluid in the brain".  Her symptomology resolved spontaneously according to her mother, "going backwards" with the last symptoms resolving first and finally the pain in legs, knees, and her arm resolving.  The mother said that the doctor told her this could only happen if the meningitis had been given "directIV".  At this time the mother was mainly concerned because her daughter's arm bled and she didn't know if that meant the shot went into her vein or not.  It was reassured that the bleeding from the injection site after an immunization was not uncommon and did not mean that the vaccine accessed the vein.  The listing indicated that one or more of the events required hospitalization.  No further information is available".  "This was originally reported by the patient's mother.  The VAER ID number is 370371".  05 January 2011: A corrective version has been created in order to change the case to "not medically confirmed", as the event was originally reported by the patient's parent, who was not a health care professional.  No new relevant medical information has been added to the case.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Pain in extremity
Clinical narrative: Initial report received from another manufacturer on 20 April 2010, under reference number WAES 1004USA00917 (VAERS number 370371).  The following narrative is verbatim from that report: "This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act.  A mother reported that she brought her 16 year old daughter to hospital for "immunizations".  It was reported that her 16 year old daughter with allergies to red dye and codeine who was given the first dose of GARDASIL (lot number 663451/0216Y) into right arm, the first dose of MENACTRA (lot number U3015AA, MFR. Sanofi Pasteur) and the first dose of HAVRIX (lot number AHAVB312AA, MFR. GSK) into her left arm at about 5 pm on Tuesday 29-SEP-2009.  The mother commented "they talked to me to getting the meningitis one".  She said that the daughter got "dizzy" right away and had commented that she felt the meningitis shot "in elbow".  The mom reported that her daughter said her knees hurt on the way home and was rubbing her knees and legs in the car.  The mother took her daughter to the emergency room at around 9pm.  She said that her daughter was "delirious", she "couldn't walk or talk", and her "eyes were rolling back in her head".  The mom denied fever, respiratory distress or seizure activity in her daughter at that time.  The patient was admitted to hospital on 29-SEP-2009 and kept for 24 hours while "tests" were run.  The mother stated that the doctor was called in "consult" and that her daughter's MRI showed "fluid in the brain".  Her symptomology resolved spontaneously according to her mother, "going backwards" with the last symptoms resolving first and finally the pain in legs, knees, and her arm resolving.  The mother said that the doctor told her this could only happen if the meningitis had been given "directIV".  At this time the mother was mainly concerned because her daughter's arm bled and she didn't know if that meant the shot went into her vein or not.  It was reassured that the bleeding from the injection site after an immunization was not uncommon and did not mean that the vaccine accessed the vein.  The listing indicated that one or more of the events required hospitalization.  No further information is available".  "This was originally reported by the patient's mother.  The VAER ID number is 370371".  05 January 2011: A corrective version has been created in order to change the case to "not medically confirmed", as the event was originally reported by the patient's parent, who was not a health care professional.  No new relevant medical information has been added to the case.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Autopsy, Bacterial infection, Bacterial test, Death, Headache
Clinical narrative: Initial report received on 19 February 2010 from a health care professional. A 16 year old female patient with an unknown medical history tested positive for Neisseria Meningitidis 2 years, 7 months, 18 days (963 days) after she received a first dose of MENACTRA (lot number U2324AA) on 26 June 2007 (route and site were unknown). The patient was seen by a physician on 12 February 2010 after an emergency room visit for a sprained ankle after playing in the snow. On 13 February 2010 at 10:30 AM, the patient was found dead in her home. On 14 February 2010 the patient had a real-time PCR assay of the brain for detection of Neisseria meningitidis performed which detected Neisseria Meningitidis serogroup C DNA. A spinal tap was done during an autopsy which revealed gram negative rods Meningitis Type C DNA. The physician stated that the patient did not have any symptoms of meningitis. No further information was provided. Follow-up information received on 08 November 2010 from another manufacture (manufacturer report number WAES 1010USA03110) who had received the report from a FDA line listing (VAERS identification number 381305). The following is verbatim from the other manufactures report. "This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 year old female who on 26-JUN-2007 was vaccinated with GARDASIL IM with the first dose. Second suspect therapy included MENACTRA (lot number U2324AA) IM into the left arm with the first dose. Concomitant therapy possibly included lithium. In the evening of 12-FEB-2010, the patient experienced headache, nausea, vomiting. In the morning of 13-FEB-2010 the patient was found dead. Autopsy performed 14-FEB-2010 - meningococcal disease determined to be cause of death, Gram negative diplococci observed on brain stem area, petechial rash observed by pathologist. Neisseria meningitidis serogroup C confirmed by polymerase chain reaction (PCR) on brain stem tissue on 14-FEB-2010. The listing indicated that one or more of the events resulted in death was considered to be immediately life-threatening. No further information is available. The original reporting source was not provided. The VAERS identification number is 381305." It is noted the subject's correct age is 16 years old as calculated from birth date to onset of events. The age of 13 years old as reported in the other manufacturer's report was the subject's age at the time of the vaccination. List of Documents held by Sender: lab results.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Joint sprain, Lumbar puncture abnormal, Meningitis, Meningococcal infection, Nausea
Clinical narrative: Initial report received on 19 February 2010 from a health care professional. A 16 year old female patient with an unknown medical history tested positive for Neisseria Meningitidis 2 years, 7 months, 18 days (963 days) after she received a first dose of MENACTRA (lot number U2324AA) on 26 June 2007 (route and site were unknown). The patient was seen by a physician on 12 February 2010 after an emergency room visit for a sprained ankle after playing in the snow. On 13 February 2010 at 10:30 AM, the patient was found dead in her home. On 14 February 2010 the patient had a real-time PCR assay of the brain for detection of Neisseria meningitidis performed which detected Neisseria Meningitidis serogroup C DNA. A spinal tap was done during an autopsy which revealed gram negative rods Meningitis Type C DNA. The physician stated that the patient did not have any symptoms of meningitis. No further information was provided. Follow-up information received on 08 November 2010 from another manufacture (manufacturer report number WAES 1010USA03110) who had received the report from a FDA line listing (VAERS identification number 381305). The following is verbatim from the other manufactures report. "This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 year old female who on 26-JUN-2007 was vaccinated with GARDASIL IM with the first dose. Second suspect therapy included MENACTRA (lot number U2324AA) IM into the left arm with the first dose. Concomitant therapy possibly included lithium. In the evening of 12-FEB-2010, the patient experienced headache, nausea, vomiting. In the morning of 13-FEB-2010 the patient was found dead. Autopsy performed 14-FEB-2010 - meningococcal disease determined to be cause of death, Gram negative diplococci observed on brain stem area, petechial rash observed by pathologist. Neisseria meningitidis serogroup C confirmed by polymerase chain reaction (PCR) on brain stem tissue on 14-FEB-2010. The listing indicated that one or more of the events resulted in death was considered to be immediately life-threatening. No further information is available. The original reporting source was not provided. The VAERS identification number is 381305." It is noted the subject's correct age is 16 years old as calculated from birth date to onset of events. The age of 13 years old as reported in the other manufacturer's report was the subject's age at the time of the vaccination. List of Documents held by Sender: lab results.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Neisseria test positive, Petechiae, Polymerase chain reaction, Vomiting
Clinical narrative: Initial report received on 19 February 2010 from a health care professional. A 16 year old female patient with an unknown medical history tested positive for Neisseria Meningitidis 2 years, 7 months, 18 days (963 days) after she received a first dose of MENACTRA (lot number U2324AA) on 26 June 2007 (route and site were unknown). The patient was seen by a physician on 12 February 2010 after an emergency room visit for a sprained ankle after playing in the snow. On 13 February 2010 at 10:30 AM, the patient was found dead in her home. On 14 February 2010 the patient had a real-time PCR assay of the brain for detection of Neisseria meningitidis performed which detected Neisseria Meningitidis serogroup C DNA. A spinal tap was done during an autopsy which revealed gram negative rods Meningitis Type C DNA. The physician stated that the patient did not have any symptoms of meningitis. No further information was provided. Follow-up information received on 08 November 2010 from another manufacture (manufacturer report number WAES 1010USA03110) who had received the report from a FDA line listing (VAERS identification number 381305). The following is verbatim from the other manufactures report. "This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 year old female who on 26-JUN-2007 was vaccinated with GARDASIL IM with the first dose. Second suspect therapy included MENACTRA (lot number U2324AA) IM into the left arm with the first dose. Concomitant therapy possibly included lithium. In the evening of 12-FEB-2010, the patient experienced headache, nausea, vomiting. In the morning of 13-FEB-2010 the patient was found dead. Autopsy performed 14-FEB-2010 - meningococcal disease determined to be cause of death, Gram negative diplococci observed on brain stem area, petechial rash observed by pathologist. Neisseria meningitidis serogroup C confirmed by polymerase chain reaction (PCR) on brain stem tissue on 14-FEB-2010. The listing indicated that one or more of the events resulted in death was considered to be immediately life-threatening. No further information is available. The original reporting source was not provided. The VAERS identification number is 381305." It is noted the subject's correct age is 16 years old as calculated from birth date to onset of events. The age of 13 years old as reported in the other manufacturer's report was the subject's age at the time of the vaccination. List of Documents held by Sender: lab results.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Blood culture negative, C-reactive protein, Culture negative, Full blood count normal, Injection site erythema
Clinical narrative: Initial report received from another manufacturer on 08 November 2010 (manufacturer report number WAES 1010USA03170) who received the report from the FDA (VAERS identification number 400679). The following is verbatim from report: "This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 12 year old female who on 25-Aug-2010 was vaccinated intramuscularly with the fourth dose of GARDASIL (Lot number 666162/0565z) in her left arm. Secondary suspect included the first dose of MENACTRA (Lot number U3511AA) given intramuscularly in to the left arm, and the second dose of Varicella (Merck) (MSD) (Lot number 668080/0721z) given subcutaneously into the left arm. Concomitant therapy included ADACEL (Lot number U3083CA). On 25-AUG-2010, the patient returned with left upper arm extremity (LUE) erythema, pain, and swelling from axilla to elbow. Rapidly enlarging. Admitted for intravenous antibiotics septic work-up. Monitored for possible abscess, compartment syndrome. Given intravenously BENADRYL no pain medications. Resolved after 2 days inpatient. All culture (CX) results were negative. Lab diagnostics included blood culture (CX): negative; serum C-reactive protein test (CRP): 41 to less than 29.8; complete blood cell count (CBC); within normal limit (WNL); ultrasound (LUE U/S); negative and erythrocyte sedimentation rate (ESR); 28. No further information is available. The original reporting source was not provided. The VAERS ID number is 400679." It was noted that the date of vaccination for the GARDASIL (Lot number 666162/0565z), and Varicella was also reported as being on 23 August 2010. Documents held by sender: None.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site pain, Injection site swelling, Red blood cell sedimentation rate, Ultrasound scan normal
Clinical narrative: Initial report received from another manufacturer on 08 November 2010 (manufacturer report number WAES 1010USA03170) who received the report from the FDA (VAERS identification number 400679). The following is verbatim from report: "This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 12 year old female who on 25-Aug-2010 was vaccinated intramuscularly with the fourth dose of GARDASIL (Lot number 666162/0565z) in her left arm. Secondary suspect included the first dose of MENACTRA (Lot number U3511AA) given intramuscularly in to the left arm, and the second dose of Varicella (Merck) (MSD) (Lot number 668080/0721z) given subcutaneously into the left arm. Concomitant therapy included ADACEL (Lot number U3083CA). On 25-AUG-2010, the patient returned with left upper arm extremity (LUE) erythema, pain, and swelling from axilla to elbow. Rapidly enlarging. Admitted for intravenous antibiotics septic work-up. Monitored for possible abscess, compartment syndrome. Given intravenously BENADRYL no pain medications. Resolved after 2 days inpatient. All culture (CX) results were negative. Lab diagnostics included blood culture (CX): negative; serum C-reactive protein test (CRP): 41 to less than 29.8; complete blood cell count (CBC); within normal limit (WNL); ultrasound (LUE U/S); negative and erythrocyte sedimentation rate (ESR); 28. No further information is available. The original reporting source was not provided. The VAERS ID number is 400679." It was noted that the date of vaccination for the GARDASIL (Lot number 666162/0565z), and Varicella was also reported as being on 23 August 2010. Documents held by sender: None.
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Death, Meningococcal infection
Clinical narrative: Initial report received from a health care professional on 02 November 2010. A female patient (age not specified) received an injection (route and site not provided) in 2006 of MENACTRA, lot number not reported. On an unspecified date one and a half weeks ago, the patient died from group C meningococcal disease. No further information was available. Follow-up information was received 06 December 2010 from a health care professional who stated that the patient had not been vaccinated at their facility and they had no details to provide. The reporter further noted that this case had been handled by their local health department. Health department contact information was provided. Follow-up information received on 13 December 2010 from a health care professional. The reporter stated she had no additional information for the case and provided an alternate contact for follow-up. No new relevant medical information was provided. The reporter for this case is the same as for case number 2010-06292 and 2010-06856. Documents held by sender: None.
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Blood culture positive, CSF culture positive, Death, Disseminated intravascular coagulation, Dysarthria
Clinical narrative: Initial report received from a health care professional on 02 November 2010. A female patient (age not specified) received an injection (route and site not provided) in 2006 of MENACTRA, lot number not reported. On an unspecified date one and a half weeks ago, the patient died from group C meningococcal disease. No further information was available. Follow-up information was received 06 December 2010 from a health care professional who stated that the patient had not been vaccinated at their facility and they had no details to provide. The reporter further noted that this case had been handled by their local health department. Health department contact information was provided. Follow-up information received on 13 December 2010 from a health care professional. The reporter stated she had no additional information for the case and provided an alternate contact for follow-up. No new relevant medical information was provided. The reporter for this case is the same as for case number 2010-06292 and 2010-06856. Documents held by sender: None.
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Meningococcal infection, Neisseria test positive, Pain, Pyrexia, Renal failure
Clinical narrative: Initial report received from a health care professional on 02 November 2010. A female patient (age not specified) received an injection (route and site not provided) in 2006 of MENACTRA, lot number not reported. On an unspecified date one and a half weeks ago, the patient died from group C meningococcal disease. No further information was available. Follow-up information was received 06 December 2010 from a health care professional who stated that the patient had not been vaccinated at their facility and they had no details to provide. The reporter further noted that this case had been handled by their local health department. Health department contact information was provided. Follow-up information received on 13 December 2010 from a health care professional. The reporter stated she had no additional information for the case and provided an alternate contact for follow-up. No new relevant medical information was provided. The reporter for this case is the same as for case number 2010-06292 and 2010-06856. Documents held by sender: None.
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Respiratory failure, Septic shock, Vomiting, Waterhouse-Friderichsen syndrome
Clinical narrative: Initial report received from a health care professional on 02 November 2010. A female patient (age not specified) received an injection (route and site not provided) in 2006 of MENACTRA, lot number not reported. On an unspecified date one and a half weeks ago, the patient died from group C meningococcal disease. No further information was available. Follow-up information was received 06 December 2010 from a health care professional who stated that the patient had not been vaccinated at their facility and they had no details to provide. The reporter further noted that this case had been handled by their local health department. Health department contact information was provided. Follow-up information received on 13 December 2010 from a health care professional. The reporter stated she had no additional information for the case and provided an alternate contact for follow-up. No new relevant medical information was provided. The reporter for this case is the same as for case number 2010-06292 and 2010-06856. Documents held by sender: None.
Age: 15.0
Sex: F
Vaccine: MNQ, FLU3, MNQ, TDAP
Symptoms: Lumbar puncture abnormal, Malaise, Rash generalised, Unresponsive to stimuli
Clinical narrative: Initial report received from a health care professional on 30 December 2010.  A 16-year-old female patient received on 22 September 2009 an injection (route and site not reported) of MENACTRA, lot number U2874BA.  The patient's medical history and concomitant medications were reported as unknown.  On 30 December 2010, the patient was not feeling well.  The next day she was found unresponsive with a rash on the body.  She was taken to the hospital.  The patient had a spinal tap at the hospital which was reported as "Did not look good".  The outcome was reported as not recovered.  Follow-up information was received from the health care professional on 06 January 2011.  The patient was diagnosed with Neisseria meningitidis, as confirmed by culture; the group was unknown by the reporter.  The reporter noted that per the patient's medical record, MENACTRA had been administered subcutaneously in the right deltoid; however, the reporter stated that the documentation was "questionable" and that the route may have been incorrectly documented.  In addition to MENACTRA, the patient also received FLUZONE (lot unknown) on 22 September 2009, and one month earlier had received ADACEL (lot and date of administration not reported).  As of 03 January 2011, the patient remained hospitalized.  Documents held by sender: None.
Age: 15.0
Sex: F
Vaccine: MNQ, FLU3, MNQ, TDAP
Symptoms: Culture positive, Lumbar puncture abnormal, Malaise, Meningococcal infection, Neisseria test positive
Clinical narrative: Initial report received from a health care professional on 30 December 2010.  A 16-year-old female patient received on 22 September 2009 an injection (route and site not reported) of MENACTRA, lot number U2874BA.  The patient's medical history and concomitant medications were reported as unknown.  On 30 December 2010, the patient was not feeling well.  The next day she was found unresponsive with a rash on the body.  She was taken to the hospital.  The patient had a spinal tap at the hospital which was reported as "Did not look good".  The outcome was reported as not recovered.  Follow-up information was received from the health care professional on 06 January 2011.  The patient was diagnosed with Neisseria meningitidis, as confirmed by culture; the group was unknown by the reporter.  The reporter noted that per the patient's medical record, MENACTRA had been administered subcutaneously in the right deltoid; however, the reporter stated that the documentation was "questionable" and that the route may have been incorrectly documented.  In addition to MENACTRA, the patient also received FLUZONE (lot unknown) on 22 September 2009, and one month earlier had received ADACEL (lot and date of administration not reported).  As of 03 January 2011, the patient remained hospitalized.  Documents held by sender: None.
Age: 15.0
Sex: F
Vaccine: MNQ, FLU3, MNQ, TDAP
Symptoms: Rash generalised, Unresponsive to stimuli
Clinical narrative: Initial report received from a health care professional on 30 December 2010.  A 16-year-old female patient received on 22 September 2009 an injection (route and site not reported) of MENACTRA, lot number U2874BA.  The patient's medical history and concomitant medications were reported as unknown.  On 30 December 2010, the patient was not feeling well.  The next day she was found unresponsive with a rash on the body.  She was taken to the hospital.  The patient had a spinal tap at the hospital which was reported as "Did not look good".  The outcome was reported as not recovered.  Follow-up information was received from the health care professional on 06 January 2011.  The patient was diagnosed with Neisseria meningitidis, as confirmed by culture; the group was unknown by the reporter.  The reporter noted that per the patient's medical record, MENACTRA had been administered subcutaneously in the right deltoid; however, the reporter stated that the documentation was "questionable" and that the route may have been incorrectly documented.  In addition to MENACTRA, the patient also received FLUZONE (lot unknown) on 22 September 2009, and one month earlier had received ADACEL (lot and date of administration not reported).  As of 03 January 2011, the patient remained hospitalized.  Documents held by sender: None.
Age: 0.37
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PPV, RV5
Symptoms: Enema administration, Intussusception
Clinical narrative: Information has been received from a physician concerning a 26 week old female who on 24-JUN-2010 and on 14-SEP-2010 was vaccinated orally with the first and second dose of ROTATEQ (lot#03502) respectively. Secondary suspect therapy included HEPATITIS B (manufacturer unknown). Concomitant therapy included HIB (unspecified carrier), SYNFLORIX. On 01-NOV-2010 the patient experienced intussusception and vomiting. The subject was seen in the emergency room for vomiting on 01-NOV-2010. Diagnostic procedures for intussusception include plain abdominal radiograph showing a visible intussusception, fluid levels and dilated bowel loops and demonstrated invagination of the intestine by air or liquid contrast enema. Abdominal ultrasound demonstrated an intra-abdominal mass with specific characteristic features that proved to be reduced by hydrostatic enema on post-reduction ultrasound. The subject's intussusception resolved with liquid contrast/hydrostatic water/air enema. The subject was hospitalized and the physician considered the events were clinically significant (or requiring intervention). At the time of reporting, the intussusception resolved on 01-NOV-2010; the outcome of the vomiting was unspecified. Additional information has been requested.
Age: 0.37
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PPV, RV5
Symptoms: Abdominal X-ray, Abdominal mass, Barium double contrast, Enema administration, Intussusception
Clinical narrative: Information has been received from a physician concerning a 26 week old female who on 24-JUN-2010 and on 14-SEP-2010 was vaccinated orally with the first and second dose of ROTATEQ (lot#03502) respectively. Secondary suspect therapy included HEPATITIS B (manufacturer unknown). Concomitant therapy included HIB (unspecified carrier), SYNFLORIX. On 01-NOV-2010 the patient experienced intussusception and vomiting. The subject was seen in the emergency room for vomiting on 01-NOV-2010. Diagnostic procedures for intussusception include plain abdominal radiograph showing a visible intussusception, fluid levels and dilated bowel loops and demonstrated invagination of the intestine by air or liquid contrast enema. Abdominal ultrasound demonstrated an intra-abdominal mass with specific characteristic features that proved to be reduced by hydrostatic enema on post-reduction ultrasound. The subject's intussusception resolved with liquid contrast/hydrostatic water/air enema. The subject was hospitalized and the physician considered the events were clinically significant (or requiring intervention). At the time of reporting, the intussusception resolved on 01-NOV-2010; the outcome of the vomiting was unspecified. Additional information has been requested.
Age: 0.37
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PPV, RV5
Symptoms: Ultrasound abdomen abnormal, Vomiting, X-ray abnormal
Clinical narrative: Information has been received from a physician concerning a 26 week old female who on 24-JUN-2010 and on 14-SEP-2010 was vaccinated orally with the first and second dose of ROTATEQ (lot#03502) respectively. Secondary suspect therapy included HEPATITIS B (manufacturer unknown). Concomitant therapy included HIB (unspecified carrier), SYNFLORIX. On 01-NOV-2010 the patient experienced intussusception and vomiting. The subject was seen in the emergency room for vomiting on 01-NOV-2010. Diagnostic procedures for intussusception include plain abdominal radiograph showing a visible intussusception, fluid levels and dilated bowel loops and demonstrated invagination of the intestine by air or liquid contrast enema. Abdominal ultrasound demonstrated an intra-abdominal mass with specific characteristic features that proved to be reduced by hydrostatic enema on post-reduction ultrasound. The subject's intussusception resolved with liquid contrast/hydrostatic water/air enema. The subject was hospitalized and the physician considered the events were clinically significant (or requiring intervention). At the time of reporting, the intussusception resolved on 01-NOV-2010; the outcome of the vomiting was unspecified. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome, Malaise, Muscular weakness, Nasopharyngitis, Weight decreased
Clinical narrative: Started out as cold like symptoms, but continued to get worse. Lost 30-35 lbs over 2 weeks. Has extreme muscle weakness. Was admitted to hospital, where he was diagnosed with Guillain-Barre Syndrome. Was in the hospital for 2 weeks. Still has significant muscle weakness and is currently seeking therapy and specialists. Still trying to get answers. Started getting sick before Thanksgiving and was admitted to the hospital Xmas day.
Age: 1.59
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Pt. received DTaP & IPV within 17 days of each other. DOH administered DTaP/IPV/HIB on 1/11/11. Another office administered DTaP/IPV/HEP B on 1/28/11. No adverse reaction noted.
Age: 14.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug exposure during pregnancy
Clinical narrative: Pt received live virus while pregnant - EDC 5/2/2011 (about 16 weeks).
Age: 1.77
Sex: F
Vaccine: DTAPHEPBIP, HEPA
Symptoms: Contusion, Injection site oedema, Skin discolouration
Clinical narrative: Mother noted left anterior thigh with 10 cm or so area of mild/soft edema, with mild bluish central contusion.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Intussusception, Laboratory test, Screaming
Clinical narrative: Constant screaming...Took to ER. Has intussusception. Given morphine and flown by air to another facility. Self-corrected.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Eye movement disorder, Ophthalmological examination abnormal, VIth nerve paralysis
Clinical narrative: A serious spontaneous report of sixth nerve palsy has been received from a consumer concerning a four year-old male, subsequent to FLUMIST. The patient was reported to have no medical history and concomitant medications were not reported. The patient received FLUMIST in Sep-2010 intranasally. A week after administration of FLUMIST the parents of the child reported they noted some "eye problems" in their son with one eye crossed inward towards the nose. The child was seen by an ophthalmologist and diagnosed with sixth nerve palsy. There were no reports of head trauma; diabetes, viruses and a brain tumor were ruled out. It was reported that the child has since gained all movement back in his eye and the event resolved spontaneously. According to the parents, both they and the child's pediatrician feel the event was related to FLUMIST.
Sex: M
Vaccine: FLUN3
Symptoms: Autopsy, Death, Influenza
Clinical narrative: A serious spontaneous report of INFLUENZA has been received from a non-healthcare professional concerning a male, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient was presumed to be an active employee. On an unknown date, the patient received FLUMIST. Five weeks after receiving FLUMIST, the patient developed symptoms of INFLUENZA. On an unknown date, the patient died. An autopsy was performed. Endemic H1N1 was isolated from the bronchioles. The cause of death was reported as INFLUENZA. The outcome of the event of INFLUENZA was fatal.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Tenderness
Clinical narrative: C/o soreness to deltoid right S/P ADACEL injection. Pain occ. persists rated 4-5/10 esp. point tenderness. Tx'd with Ibuprofen 600mg q 8 hours. Pain continues today.
Sex: U
Vaccine: FLU3, HEP
Symptoms: Rash, Rash erythematous
Clinical narrative: Pt. presented to hospital emergency dept. 4 hour after flu vaccine with red rash on trunk, arms and legs. Treated and released.