chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: M
Vaccine: YF
Symptoms: Photophobia, Pyrexia, Red blood cells CSF positive, Urinary retention, Varicella virus test positive
Clinical narrative: Literature report received on 26 October 2009. Case report: "A 23-year-old previously healthy man received immunization against yellow fever (17-D-204) 2 weeks prior to a travel out of country. Three weeks later, he developed fever, nausea, vomiting, severe bifrontal headaches and photophobia, followed by ascending weakness of the lower limbs, paresthesias of his feet, and urinary retention. On examination, he was febrile, had mild nuchal rigidity, and exhibited unsustained horizontal nystagmus on left gaze, discrete left arm dysemtria, bilateral symmetric lower extremity paresis, patellar and ankle hyperreflexia, and impaired sensation to light-touch and pinpick with an ill defined sensory level around T9. Magnetic resonance imaging (MRI) of the brain and spinal cord showed areas of high signal intensity on T2 weighted and fluid attenuation inversion recovery (FLAIR) in the middle cerebellar penduncle, right dorsal medulla oblongata and a multilevel lesion involving the thoracic spinal cord with subtle patchy heterogeneous enhancement after administration of gadolinium. Cerebrospinal fluid (CSF) analysis showed clear and colorless fluid with a normal opening pressure. Cell count was elevated with 62 white blood cells (neutrophils 41%, lymphocytes 46%, monocytes 13%) 17 red blood cells, glucose 54 mg/100mL (serum glucose 154 mg/100mL) and a protein content of 105 mg/dL. CSF cultures were negative. Serum and CSF evaluations for herpes simplex virus type 1 and 2, epstein barr virus, human T-lymphotropic virus 1 and 2, rabies virus, arbovirus, barthonella quintana, rickettsias, brucellas spp, leptospiras, salmonella, borrelias, mycobaterias, treponema pallidum, plasmodium, cryptococcus and mycoplasma were negative. CSF myelin basic protein (MBP) was elevated with a level of 618 ng/mL. CSF total IgG level, and IgG index were normal. CSF specific IgM antibodies to YEL levels were elevated with a level of 15.6, IgM and IgG specific antibodies to YEL levels in serum were 4.8 and 1.4 respectively (normal is less than 2.0). The patient received a five-day course of 1 gram daily of intravenous methylprednisolone, with marked clinical improvement. MRI of brain and entire spine showed resolution of previous lesions 30 days after initiation of therapy." Follow-up information received 09 November 2009 from a co-author of the literature report. The reporter confirmed that the patient had been vaccinated in the country, not out of the country. The vaccine administered was YF VAX (lot number not reported). No additional information was provided.
Age: 23.0
Sex: M
Vaccine: YF
Symptoms: Viral test negative, Vomiting
Clinical narrative: Literature report received on 26 October 2009. Case report: "A 23-year-old previously healthy man received immunization against yellow fever (17-D-204) 2 weeks prior to a travel out of country. Three weeks later, he developed fever, nausea, vomiting, severe bifrontal headaches and photophobia, followed by ascending weakness of the lower limbs, paresthesias of his feet, and urinary retention. On examination, he was febrile, had mild nuchal rigidity, and exhibited unsustained horizontal nystagmus on left gaze, discrete left arm dysemtria, bilateral symmetric lower extremity paresis, patellar and ankle hyperreflexia, and impaired sensation to light-touch and pinpick with an ill defined sensory level around T9. Magnetic resonance imaging (MRI) of the brain and spinal cord showed areas of high signal intensity on T2 weighted and fluid attenuation inversion recovery (FLAIR) in the middle cerebellar penduncle, right dorsal medulla oblongata and a multilevel lesion involving the thoracic spinal cord with subtle patchy heterogeneous enhancement after administration of gadolinium. Cerebrospinal fluid (CSF) analysis showed clear and colorless fluid with a normal opening pressure. Cell count was elevated with 62 white blood cells (neutrophils 41%, lymphocytes 46%, monocytes 13%) 17 red blood cells, glucose 54 mg/100mL (serum glucose 154 mg/100mL) and a protein content of 105 mg/dL. CSF cultures were negative. Serum and CSF evaluations for herpes simplex virus type 1 and 2, epstein barr virus, human T-lymphotropic virus 1 and 2, rabies virus, arbovirus, barthonella quintana, rickettsias, brucellas spp, leptospiras, salmonella, borrelias, mycobaterias, treponema pallidum, plasmodium, cryptococcus and mycoplasma were negative. CSF myelin basic protein (MBP) was elevated with a level of 618 ng/mL. CSF total IgG level, and IgG index were normal. CSF specific IgM antibodies to YEL levels were elevated with a level of 15.6, IgM and IgG specific antibodies to YEL levels in serum were 4.8 and 1.4 respectively (normal is less than 2.0). The patient received a five-day course of 1 gram daily of intravenous methylprednisolone, with marked clinical improvement. MRI of brain and entire spine showed resolution of previous lesions 30 days after initiation of therapy." Follow-up information received 09 November 2009 from a co-author of the literature report. The reporter confirmed that the patient had been vaccinated in the country, not out of the country. The vaccine administered was YF VAX (lot number not reported). No additional information was provided.
Age: 31.0
Sex: M
Vaccine: SMALL, YF, SMALL, YF
Symptoms: Electroencephalogram normal, Endotracheal intubation, Headache, Insomnia, Mental disorder
Clinical narrative: This case was received on 01 March 2010 via a QScan search on the VAERS database, under the reference number 369593. A 31 year-old male patient received the following vaccines on 17 June 2009: a percutaneous injection of ACAM2000 (lot number VV04-003) and YF-VAX (lot number UF434AA). The sites of administration were not reported. It was reported that the patient was well on the day of and prior to vaccination. He developed new onset daily headaches 1-2 days later, rated 5 out of 10 on a pain scale and self-treated with TYLENOL as needed. The patient reported no visual disturbance or any other neurologic, systemic or constitutional symptoms, except a single isolated brief episode of mental lapse described as "forgetting to make planned left turn" at a usual familiar intersection. The patient had normal take at his smallpox vaccination site. It was also reported that the patient received a first dose of Anthrax vaccine and MGC vaccine on 11 June 2009 (6 days prior to smallpox vaccination). The patient had no known allergies to drugs, foods, latex or insects. On the night of 23 June 2009, the patient had motorcycle accident (helmeted) while driving on a familiar route with good visibility and no other vehicle or pedestrian involvement; he sustained a serious closed head injury and was hospitalized for 8 days, requiring short term intubation and treatment with IV ATIVAN and KEPPRA. He was noted to have waxing/waning consciousness and seizure activity on arrival to the Emergency Department. Toxicology screen was negative. A head CT on 24 June 2009 revealed small left occipital condyle fracture with subarachnoid hemorrhage and small falx subdural hematoma; also had right clavicular comminuted fracture. Brain MRI on 26 June 2009 revealed grade II diffuse axonal injury involving splenium of corpus callosum and white lobar matter; FLAIR sequences demonstrated residual blood byproducts in falx; electroencephalogram on 28 June 2009 was normal. He was discharged on 01 July 2009 in stable condition with GCS 15, ambulating well and tolerating a regular diet. His pain was controlled with oral pain medications. He was transferred to rehabilitation facility for about 2 weeks of therapy. On 16 July 2009 the patient had an ORIF repair of his right clavicle fracture. He had vertigo post hospitalization, resolved with Epley maneuver; residual mild recurrent headaches, continued neck and right shoulder pain, and insomnia. In August 2009 N/P evaluation (per patient) indicated some deficits in processing speed, short term memory loss, and executive decision-making. He has had gradual continuous improvement but continues follow-up with speech and occupational therapy as well as neurology. He remains on a physical profile as of November 2009. Note: There may be a discrepancy between the event onset date filed and the onset date information in the free text narrative field in the data reported. Latency has been calculated using the date that is in the narrative. List of documents held by sender: None.
Age: 31.0
Sex: M
Vaccine: SMALL, YF, SMALL, YF
Symptoms: Vertigo
Clinical narrative: This case was received on 01 March 2010 via a QScan search on the VAERS database, under the reference number 369593. A 31 year-old male patient received the following vaccines on 17 June 2009: a percutaneous injection of ACAM2000 (lot number VV04-003) and YF-VAX (lot number UF434AA). The sites of administration were not reported. It was reported that the patient was well on the day of and prior to vaccination. He developed new onset daily headaches 1-2 days later, rated 5 out of 10 on a pain scale and self-treated with TYLENOL as needed. The patient reported no visual disturbance or any other neurologic, systemic or constitutional symptoms, except a single isolated brief episode of mental lapse described as "forgetting to make planned left turn" at a usual familiar intersection. The patient had normal take at his smallpox vaccination site. It was also reported that the patient received a first dose of Anthrax vaccine and MGC vaccine on 11 June 2009 (6 days prior to smallpox vaccination). The patient had no known allergies to drugs, foods, latex or insects. On the night of 23 June 2009, the patient had motorcycle accident (helmeted) while driving on a familiar route with good visibility and no other vehicle or pedestrian involvement; he sustained a serious closed head injury and was hospitalized for 8 days, requiring short term intubation and treatment with IV ATIVAN and KEPPRA. He was noted to have waxing/waning consciousness and seizure activity on arrival to the Emergency Department. Toxicology screen was negative. A head CT on 24 June 2009 revealed small left occipital condyle fracture with subarachnoid hemorrhage and small falx subdural hematoma; also had right clavicular comminuted fracture. Brain MRI on 26 June 2009 revealed grade II diffuse axonal injury involving splenium of corpus callosum and white lobar matter; FLAIR sequences demonstrated residual blood byproducts in falx; electroencephalogram on 28 June 2009 was normal. He was discharged on 01 July 2009 in stable condition with GCS 15, ambulating well and tolerating a regular diet. His pain was controlled with oral pain medications. He was transferred to rehabilitation facility for about 2 weeks of therapy. On 16 July 2009 the patient had an ORIF repair of his right clavicle fracture. He had vertigo post hospitalization, resolved with Epley maneuver; residual mild recurrent headaches, continued neck and right shoulder pain, and insomnia. In August 2009 N/P evaluation (per patient) indicated some deficits in processing speed, short term memory loss, and executive decision-making. He has had gradual continuous improvement but continues follow-up with speech and occupational therapy as well as neurology. He remains on a physical profile as of November 2009. Note: There may be a discrepancy between the event onset date filed and the onset date information in the free text narrative field in the data reported. Latency has been calculated using the date that is in the narrative. List of documents held by sender: None.
Age: 31.0
Sex: M
Vaccine: SMALL, YF, SMALL, YF
Symptoms: Electroencephalogram normal, Endotracheal intubation, Head injury, Headache, Insomnia
Clinical narrative: This case was received on 01 March 2010 via a QScan search on the VAERS database, under the reference number 369593. A 31 year-old male patient received the following vaccines on 17 June 2009: a percutaneous injection of ACAM2000 (lot number VV04-003) and YF-VAX (lot number UF434AA). The sites of administration were not reported. It was reported that the patient was well on the day of and prior to vaccination. He developed new onset daily headaches 1-2 days later, rated 5 out of 10 on a pain scale and self-treated with TYLENOL as needed. The patient reported no visual disturbance or any other neurologic, systemic or constitutional symptoms, except a single isolated brief episode of mental lapse described as "forgetting to make planned left turn" at a usual familiar intersection. The patient had normal take at his smallpox vaccination site. It was also reported that the patient received a first dose of Anthrax vaccine and MGC vaccine on 11 June 2009 (6 days prior to smallpox vaccination). The patient had no known allergies to drugs, foods, latex or insects. On the night of 23 June 2009, the patient had motorcycle accident (helmeted) while driving on a familiar route with good visibility and no other vehicle or pedestrian involvement; he sustained a serious closed head injury and was hospitalized for 8 days, requiring short term intubation and treatment with IV ATIVAN and KEPPRA. He was noted to have waxing/waning consciousness and seizure activity on arrival to the Emergency Department. Toxicology screen was negative. A head CT on 24 June 2009 revealed small left occipital condyle fracture with subarachnoid hemorrhage and small falx subdural hematoma; also had right clavicular comminuted fracture. Brain MRI on 26 June 2009 revealed grade II diffuse axonal injury involving splenium of corpus callosum and white lobar matter; FLAIR sequences demonstrated residual blood byproducts in falx; electroencephalogram on 28 June 2009 was normal. He was discharged on 01 July 2009 in stable condition with GCS 15, ambulating well and tolerating a regular diet. His pain was controlled with oral pain medications. He was transferred to rehabilitation facility for about 2 weeks of therapy. On 16 July 2009 the patient had an ORIF repair of his right clavicle fracture. He had vertigo post hospitalization, resolved with Epley maneuver; residual mild recurrent headaches, continued neck and right shoulder pain, and insomnia. In August 2009 N/P evaluation (per patient) indicated some deficits in processing speed, short term memory loss, and executive decision-making. He has had gradual continuous improvement but continues follow-up with speech and occupational therapy as well as neurology. He remains on a physical profile as of November 2009. Note: There may be a discrepancy between the event onset date filed and the onset date information in the free text narrative field in the data reported. Latency has been calculated using the date that is in the narrative. List of documents held by sender: None.
Age: 31.0
Sex: M
Vaccine: SMALL, YF, SMALL, YF
Symptoms: Subdural haematoma, Toxicologic test normal, Vertigo
Clinical narrative: This case was received on 01 March 2010 via a QScan search on the VAERS database, under the reference number 369593. A 31 year-old male patient received the following vaccines on 17 June 2009: a percutaneous injection of ACAM2000 (lot number VV04-003) and YF-VAX (lot number UF434AA). The sites of administration were not reported. It was reported that the patient was well on the day of and prior to vaccination. He developed new onset daily headaches 1-2 days later, rated 5 out of 10 on a pain scale and self-treated with TYLENOL as needed. The patient reported no visual disturbance or any other neurologic, systemic or constitutional symptoms, except a single isolated brief episode of mental lapse described as "forgetting to make planned left turn" at a usual familiar intersection. The patient had normal take at his smallpox vaccination site. It was also reported that the patient received a first dose of Anthrax vaccine and MGC vaccine on 11 June 2009 (6 days prior to smallpox vaccination). The patient had no known allergies to drugs, foods, latex or insects. On the night of 23 June 2009, the patient had motorcycle accident (helmeted) while driving on a familiar route with good visibility and no other vehicle or pedestrian involvement; he sustained a serious closed head injury and was hospitalized for 8 days, requiring short term intubation and treatment with IV ATIVAN and KEPPRA. He was noted to have waxing/waning consciousness and seizure activity on arrival to the Emergency Department. Toxicology screen was negative. A head CT on 24 June 2009 revealed small left occipital condyle fracture with subarachnoid hemorrhage and small falx subdural hematoma; also had right clavicular comminuted fracture. Brain MRI on 26 June 2009 revealed grade II diffuse axonal injury involving splenium of corpus callosum and white lobar matter; FLAIR sequences demonstrated residual blood byproducts in falx; electroencephalogram on 28 June 2009 was normal. He was discharged on 01 July 2009 in stable condition with GCS 15, ambulating well and tolerating a regular diet. His pain was controlled with oral pain medications. He was transferred to rehabilitation facility for about 2 weeks of therapy. On 16 July 2009 the patient had an ORIF repair of his right clavicle fracture. He had vertigo post hospitalization, resolved with Epley maneuver; residual mild recurrent headaches, continued neck and right shoulder pain, and insomnia. In August 2009 N/P evaluation (per patient) indicated some deficits in processing speed, short term memory loss, and executive decision-making. He has had gradual continuous improvement but continues follow-up with speech and occupational therapy as well as neurology. He remains on a physical profile as of November 2009. Note: There may be a discrepancy between the event onset date filed and the onset date information in the free text narrative field in the data reported. Latency has been calculated using the date that is in the narrative. List of documents held by sender: None.
Age: 31.0
Sex: M
Vaccine: SMALL, YF, SMALL, YF
Symptoms: Amnesia, Bradyphrenia, Canalith repositioning procedure, Clavicle fracture, Coma scale normal
Clinical narrative: This case was received on 01 March 2010 via a QScan search in the VAERS database, under reference number 369593. A 31 year-old male patient received the following vaccines on 17 June 2009: a percutaneous injection of ACAM2000 (lot number VV04-003) and YF-VAX (lot number UF434AA). The sites of administration were not reported. It was reported that the patient was well on the day of and prior to vaccination. He developed new onset daily headaches 1-2 days later, rated 5 out of 10 on a pain scale and self-treated with TYLENOL as needed. The patient reported no visual disturbances or any other neurologic, systemic or constitutional symptoms, except a single isolated brief episode of mental lapse described as "forgetting to make planned left turn" at a usual familiar intersection. The patient had normal take at his smallpox vaccination site. It was also reported that the patient received a first dose of ANTHRAX and MGC on 11 June 2009 (6 days prior to smallpox vaccination). The patient had no known allergies to drugs, foods, latex or insects. On the night of 23 June 2009, the patient had motorcycle accident (helmeted) while driving on a familiar route with good visibility and no other vehicle or pedestrian involvement; he sustained a serious closed head injury and was hospitalized for 8 days, requiring short term intubation and treatment with IV ATIVAN and KEPPRA. He was noted to have waxing/waning consciousness and seizure activity on arrival to the emergency department. Toxicology screen was negative. A head CT on 24 June 2009 revealed small left occipital condyle fracture with subarachnoid hemorrhage and small falx subdural hematoma; also had right clavicular comminuted fracture. Brain MRI on 26 June 2009 revealed grade II diffuse axonal injury involving splenium of corpus callosum and white lobar matter; FLAIR sequences demonstrated residual blood byproducts in falx; electroencephalogram on 28 June 2009 was normal. He was discharged on 01 July 2009 in stable condition with GCS 15, ambulating well and tolerating a regular diet. His pain was controlled with oral pain medications. He was transferred to rehabilitation facility for about 2 weeks of therapy. On 16 July 2009 the patient had an ORIF repair of his right clavicle fracture. He had vertigo post hospitalization, resolved with Epley maneuver; residual mild recurrent headaches, continued neck and right shoulder pain, and insomnia. In August 2009 N/P evaluation (per patient) indicated some deficits in processing speed, short term memory loss, and executive decision-making. He has had gradual continuous improvement but continues follow-up with speech and occupational therapy as well as neurology. He remains on a physical profile as of November 2009. Note: There may be a discrepancy between the event onset date field and the onset date information on the free text narrative field in the data reported. Latency has been calculated using the date that is in the narrative. List of documents held by sender: None.
Age: 31.0
Sex: M
Vaccine: SMALL, YF, SMALL, YF
Symptoms: Comminuted fracture, Computerised tomogram head, Consciousness fluctuating, Convulsion, Diffuse axonal injury
Clinical narrative: This case was received on 01 March 2010 via a QScan search in the VAERS database, under reference number 369593. A 31 year-old male patient received the following vaccines on 17 June 2009: a percutaneous injection of ACAM2000 (lot number VV04-003) and YF-VAX (lot number UF434AA). The sites of administration were not reported. It was reported that the patient was well on the day of and prior to vaccination. He developed new onset daily headaches 1-2 days later, rated 5 out of 10 on a pain scale and self-treated with TYLENOL as needed. The patient reported no visual disturbances or any other neurologic, systemic or constitutional symptoms, except a single isolated brief episode of mental lapse described as "forgetting to make planned left turn" at a usual familiar intersection. The patient had normal take at his smallpox vaccination site. It was also reported that the patient received a first dose of ANTHRAX and MGC on 11 June 2009 (6 days prior to smallpox vaccination). The patient had no known allergies to drugs, foods, latex or insects. On the night of 23 June 2009, the patient had motorcycle accident (helmeted) while driving on a familiar route with good visibility and no other vehicle or pedestrian involvement; he sustained a serious closed head injury and was hospitalized for 8 days, requiring short term intubation and treatment with IV ATIVAN and KEPPRA. He was noted to have waxing/waning consciousness and seizure activity on arrival to the emergency department. Toxicology screen was negative. A head CT on 24 June 2009 revealed small left occipital condyle fracture with subarachnoid hemorrhage and small falx subdural hematoma; also had right clavicular comminuted fracture. Brain MRI on 26 June 2009 revealed grade II diffuse axonal injury involving splenium of corpus callosum and white lobar matter; FLAIR sequences demonstrated residual blood byproducts in falx; electroencephalogram on 28 June 2009 was normal. He was discharged on 01 July 2009 in stable condition with GCS 15, ambulating well and tolerating a regular diet. His pain was controlled with oral pain medications. He was transferred to rehabilitation facility for about 2 weeks of therapy. On 16 July 2009 the patient had an ORIF repair of his right clavicle fracture. He had vertigo post hospitalization, resolved with Epley maneuver; residual mild recurrent headaches, continued neck and right shoulder pain, and insomnia. In August 2009 N/P evaluation (per patient) indicated some deficits in processing speed, short term memory loss, and executive decision-making. He has had gradual continuous improvement but continues follow-up with speech and occupational therapy as well as neurology. He remains on a physical profile as of November 2009. Note: There may be a discrepancy between the event onset date field and the onset date information on the free text narrative field in the data reported. Latency has been calculated using the date that is in the narrative. List of documents held by sender: None.
Age: 31.0
Sex: M
Vaccine: SMALL, YF, SMALL, YF
Symptoms: Electroencephalogram normal, Endotracheal intubation, Headache, Insomnia, Mental disorder
Clinical narrative: This case was received on 01 March 2010 via a QScan search in the VAERS database, under reference number 369593. A 31 year-old male patient received the following vaccines on 17 June 2009: a percutaneous injection of ACAM2000 (lot number VV04-003) and YF-VAX (lot number UF434AA). The sites of administration were not reported. It was reported that the patient was well on the day of and prior to vaccination. He developed new onset daily headaches 1-2 days later, rated 5 out of 10 on a pain scale and self-treated with TYLENOL as needed. The patient reported no visual disturbances or any other neurologic, systemic or constitutional symptoms, except a single isolated brief episode of mental lapse described as "forgetting to make planned left turn" at a usual familiar intersection. The patient had normal take at his smallpox vaccination site. It was also reported that the patient received a first dose of ANTHRAX and MGC on 11 June 2009 (6 days prior to smallpox vaccination). The patient had no known allergies to drugs, foods, latex or insects. On the night of 23 June 2009, the patient had motorcycle accident (helmeted) while driving on a familiar route with good visibility and no other vehicle or pedestrian involvement; he sustained a serious closed head injury and was hospitalized for 8 days, requiring short term intubation and treatment with IV ATIVAN and KEPPRA. He was noted to have waxing/waning consciousness and seizure activity on arrival to the emergency department. Toxicology screen was negative. A head CT on 24 June 2009 revealed small left occipital condyle fracture with subarachnoid hemorrhage and small falx subdural hematoma; also had right clavicular comminuted fracture. Brain MRI on 26 June 2009 revealed grade II diffuse axonal injury involving splenium of corpus callosum and white lobar matter; FLAIR sequences demonstrated residual blood byproducts in falx; electroencephalogram on 28 June 2009 was normal. He was discharged on 01 July 2009 in stable condition with GCS 15, ambulating well and tolerating a regular diet. His pain was controlled with oral pain medications. He was transferred to rehabilitation facility for about 2 weeks of therapy. On 16 July 2009 the patient had an ORIF repair of his right clavicle fracture. He had vertigo post hospitalization, resolved with Epley maneuver; residual mild recurrent headaches, continued neck and right shoulder pain, and insomnia. In August 2009 N/P evaluation (per patient) indicated some deficits in processing speed, short term memory loss, and executive decision-making. He has had gradual continuous improvement but continues follow-up with speech and occupational therapy as well as neurology. He remains on a physical profile as of November 2009. Note: There may be a discrepancy between the event onset date field and the onset date information on the free text narrative field in the data reported. Latency has been calculated using the date that is in the narrative. List of documents held by sender: None.
Age: 31.0
Sex: M
Vaccine: SMALL, YF, SMALL, YF
Symptoms: Vertigo
Clinical narrative: This case was received on 01 March 2010 via a QScan search in the VAERS database, under reference number 369593. A 31 year-old male patient received the following vaccines on 17 June 2009: a percutaneous injection of ACAM2000 (lot number VV04-003) and YF-VAX (lot number UF434AA). The sites of administration were not reported. It was reported that the patient was well on the day of and prior to vaccination. He developed new onset daily headaches 1-2 days later, rated 5 out of 10 on a pain scale and self-treated with TYLENOL as needed. The patient reported no visual disturbances or any other neurologic, systemic or constitutional symptoms, except a single isolated brief episode of mental lapse described as "forgetting to make planned left turn" at a usual familiar intersection. The patient had normal take at his smallpox vaccination site. It was also reported that the patient received a first dose of ANTHRAX and MGC on 11 June 2009 (6 days prior to smallpox vaccination). The patient had no known allergies to drugs, foods, latex or insects. On the night of 23 June 2009, the patient had motorcycle accident (helmeted) while driving on a familiar route with good visibility and no other vehicle or pedestrian involvement; he sustained a serious closed head injury and was hospitalized for 8 days, requiring short term intubation and treatment with IV ATIVAN and KEPPRA. He was noted to have waxing/waning consciousness and seizure activity on arrival to the emergency department. Toxicology screen was negative. A head CT on 24 June 2009 revealed small left occipital condyle fracture with subarachnoid hemorrhage and small falx subdural hematoma; also had right clavicular comminuted fracture. Brain MRI on 26 June 2009 revealed grade II diffuse axonal injury involving splenium of corpus callosum and white lobar matter; FLAIR sequences demonstrated residual blood byproducts in falx; electroencephalogram on 28 June 2009 was normal. He was discharged on 01 July 2009 in stable condition with GCS 15, ambulating well and tolerating a regular diet. His pain was controlled with oral pain medications. He was transferred to rehabilitation facility for about 2 weeks of therapy. On 16 July 2009 the patient had an ORIF repair of his right clavicle fracture. He had vertigo post hospitalization, resolved with Epley maneuver; residual mild recurrent headaches, continued neck and right shoulder pain, and insomnia. In August 2009 N/P evaluation (per patient) indicated some deficits in processing speed, short term memory loss, and executive decision-making. He has had gradual continuous improvement but continues follow-up with speech and occupational therapy as well as neurology. He remains on a physical profile as of November 2009. Note: There may be a discrepancy between the event onset date field and the onset date information on the free text narrative field in the data reported. Latency has been calculated using the date that is in the narrative. List of documents held by sender: None.
Age: 31.0
Sex: M
Vaccine: SMALL, YF, SMALL, YF
Symptoms: Clavicle fracture, Computerised tomogram abnormal, Consciousness fluctuating, Convulsion, Diffuse axonal injury
Clinical narrative: This case was received on 01 March 2010 via a QScan search in the VAERS database, under reference number 369593. A 31 year-old male patient received the following vaccines on 17 June 2009: a percutaneous injection of ACAM2000 (lot number VV04-003) and YF-VAX (lot number UF434AA). The sites of administration were not reported. It was reported that the patient was well on the day of and prior to vaccination. He developed new onset daily headaches 1-2 days later, rated 5 out of 10 on a pain scale and self-treated with TYLENOL as needed. The patient reported no visual disturbances or any other neurologic, systemic or constitutional symptoms, except a single isolated brief episode of mental lapse described as "forgetting to make planned left turn" at a usual familiar intersection. The patient had normal take at his smallpox vaccination site. It was also reported that the patient received a first dose of ANTHRAX and MGC on 11 June 2009 (6 days prior to smallpox vaccination). The patient had no known allergies to drugs, foods, latex or insects. On the night of 23 June 2009, the patient had motorcycle accident (helmeted) while driving on a familiar route with good visibility and no other vehicle or pedestrian involvement; he sustained a serious closed head injury and was hospitalized for 8 days, requiring short term intubation and treatment with IV ATIVAN and KEPPRA. He was noted to have waxing/waning consciousness and seizure activity on arrival to the emergency department. Toxicology screen was negative. A head CT on 24 June 2009 revealed small left occipital condyle fracture with subarachnoid hemorrhage and small falx subdural hematoma; also had right clavicular comminuted fracture. Brain MRI on 26 June 2009 revealed grade II diffuse axonal injury involving splenium of corpus callosum and white lobar matter; FLAIR sequences demonstrated residual blood byproducts in falx; electroencephalogram on 28 June 2009 was normal. He was discharged on 01 July 2009 in stable condition with GCS 15, ambulating well and tolerating a regular diet. His pain was controlled with oral pain medications. He was transferred to rehabilitation facility for about 2 weeks of therapy. On 16 July 2009 the patient had an ORIF repair of his right clavicle fracture. He had vertigo post hospitalization, resolved with Epley maneuver; residual mild recurrent headaches, continued neck and right shoulder pain, and insomnia. In August 2009 N/P evaluation (per patient) indicated some deficits in processing speed, short term memory loss, and executive decision-making. He has had gradual continuous improvement but continues follow-up with speech and occupational therapy as well as neurology. He remains on a physical profile as of November 2009. Note: There may be a discrepancy between the event onset date field and the onset date information on the free text narrative field in the data reported. Latency has been calculated using the date that is in the narrative. List of documents held by sender: None.
Age: 31.0
Sex: M
Vaccine: SMALL, YF, SMALL, YF
Symptoms: Electroencephalogram normal, Endotracheal intubation, Head injury, Headache, Insomnia
Clinical narrative: This case was received on 01 March 2010 via a QScan search in the VAERS database, under reference number 369593. A 31 year-old male patient received the following vaccines on 17 June 2009: a percutaneous injection of ACAM2000 (lot number VV04-003) and YF-VAX (lot number UF434AA). The sites of administration were not reported. It was reported that the patient was well on the day of and prior to vaccination. He developed new onset daily headaches 1-2 days later, rated 5 out of 10 on a pain scale and self-treated with TYLENOL as needed. The patient reported no visual disturbances or any other neurologic, systemic or constitutional symptoms, except a single isolated brief episode of mental lapse described as "forgetting to make planned left turn" at a usual familiar intersection. The patient had normal take at his smallpox vaccination site. It was also reported that the patient received a first dose of ANTHRAX and MGC on 11 June 2009 (6 days prior to smallpox vaccination). The patient had no known allergies to drugs, foods, latex or insects. On the night of 23 June 2009, the patient had motorcycle accident (helmeted) while driving on a familiar route with good visibility and no other vehicle or pedestrian involvement; he sustained a serious closed head injury and was hospitalized for 8 days, requiring short term intubation and treatment with IV ATIVAN and KEPPRA. He was noted to have waxing/waning consciousness and seizure activity on arrival to the emergency department. Toxicology screen was negative. A head CT on 24 June 2009 revealed small left occipital condyle fracture with subarachnoid hemorrhage and small falx subdural hematoma; also had right clavicular comminuted fracture. Brain MRI on 26 June 2009 revealed grade II diffuse axonal injury involving splenium of corpus callosum and white lobar matter; FLAIR sequences demonstrated residual blood byproducts in falx; electroencephalogram on 28 June 2009 was normal. He was discharged on 01 July 2009 in stable condition with GCS 15, ambulating well and tolerating a regular diet. His pain was controlled with oral pain medications. He was transferred to rehabilitation facility for about 2 weeks of therapy. On 16 July 2009 the patient had an ORIF repair of his right clavicle fracture. He had vertigo post hospitalization, resolved with Epley maneuver; residual mild recurrent headaches, continued neck and right shoulder pain, and insomnia. In August 2009 N/P evaluation (per patient) indicated some deficits in processing speed, short term memory loss, and executive decision-making. He has had gradual continuous improvement but continues follow-up with speech and occupational therapy as well as neurology. He remains on a physical profile as of November 2009. Note: There may be a discrepancy between the event onset date field and the onset date information on the free text narrative field in the data reported. Latency has been calculated using the date that is in the narrative. List of documents held by sender: None.
Age: 31.0
Sex: M
Vaccine: SMALL, YF, SMALL, YF
Symptoms: Subdural haematoma, Toxicologic test normal, Vertigo
Clinical narrative: This case was received on 01 March 2010 via a QScan search in the VAERS database, under reference number 369593. A 31 year-old male patient received the following vaccines on 17 June 2009: a percutaneous injection of ACAM2000 (lot number VV04-003) and YF-VAX (lot number UF434AA). The sites of administration were not reported. It was reported that the patient was well on the day of and prior to vaccination. He developed new onset daily headaches 1-2 days later, rated 5 out of 10 on a pain scale and self-treated with TYLENOL as needed. The patient reported no visual disturbances or any other neurologic, systemic or constitutional symptoms, except a single isolated brief episode of mental lapse described as "forgetting to make planned left turn" at a usual familiar intersection. The patient had normal take at his smallpox vaccination site. It was also reported that the patient received a first dose of ANTHRAX and MGC on 11 June 2009 (6 days prior to smallpox vaccination). The patient had no known allergies to drugs, foods, latex or insects. On the night of 23 June 2009, the patient had motorcycle accident (helmeted) while driving on a familiar route with good visibility and no other vehicle or pedestrian involvement; he sustained a serious closed head injury and was hospitalized for 8 days, requiring short term intubation and treatment with IV ATIVAN and KEPPRA. He was noted to have waxing/waning consciousness and seizure activity on arrival to the emergency department. Toxicology screen was negative. A head CT on 24 June 2009 revealed small left occipital condyle fracture with subarachnoid hemorrhage and small falx subdural hematoma; also had right clavicular comminuted fracture. Brain MRI on 26 June 2009 revealed grade II diffuse axonal injury involving splenium of corpus callosum and white lobar matter; FLAIR sequences demonstrated residual blood byproducts in falx; electroencephalogram on 28 June 2009 was normal. He was discharged on 01 July 2009 in stable condition with GCS 15, ambulating well and tolerating a regular diet. His pain was controlled with oral pain medications. He was transferred to rehabilitation facility for about 2 weeks of therapy. On 16 July 2009 the patient had an ORIF repair of his right clavicle fracture. He had vertigo post hospitalization, resolved with Epley maneuver; residual mild recurrent headaches, continued neck and right shoulder pain, and insomnia. In August 2009 N/P evaluation (per patient) indicated some deficits in processing speed, short term memory loss, and executive decision-making. He has had gradual continuous improvement but continues follow-up with speech and occupational therapy as well as neurology. He remains on a physical profile as of November 2009. Note: There may be a discrepancy between the event onset date field and the onset date information on the free text narrative field in the data reported. Latency has been calculated using the date that is in the narrative. List of documents held by sender: None.
Age: 20.0
Sex: F
Vaccine: SMALL
Symptoms: Generalised vaccinia, Rash pruritic
Clinical narrative: This case was received on 01 March 2010 via a QScan search on the VAERS database, under reference number 370309. A 20 year-old female patient received the following vaccine on 08 November 2009: a percutaneous injection of ACAM2000 (lot number reported as ACAM2000, to be verified). The site of administration were not reported. Seventeen days post vaccination the patient reported a small pruritic patch on left inner thigh initially, then diffuse rash over next few days, especially on posterior aspect of bilateral axillae and inner thighs. Primary vaccine site healing well. No systemic symptoms were reported. Not toxic looking. Diagnosed with generalized vaccinia (mild) and treated with supportive care: Hydroxyzine 25-50 mg four times per day as needed for pruritus and ZANTAC 150 mg twice per day as needed. The patient was to follow-up in 24 hours for a recheck. Patient was educated on Erythema Multiforme. List of documents held by sender: none.
Age: 75.0
Sex: M
Vaccine: FLU3, IPV, MMR, PPV, SMALL, TD
Symptoms: Decreased appetite, Fatigue, Hypersomnia, Pyrexia
Clinical narrative: This case was received on 01 March 2010 via a QScan search on the VAERS database, under reference number 370379. A 75 year old male received the following on 16 November 2009: ACAM2000 (lot number not reported); pneumococcal vaccine; measles, mumps and rubella vaccine; tetanus toxoid; diphtheria toxoid; and FLUVIRIN (Novartis lot number not reported). Unless indicated above, the manufacturer, lot number, routes and sites of administration were not reported. One day post-vaccination, the patient was very tired, sleeping for 20 hours per day for 4 days. The patient had a fever (reported as 100-101), and couldn't eat. He was able to drink. He reported drinking lots of fluids and taking aspirin. No additional information was provided. NOTE: Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination.  List of documents held by sender: none
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Chest discomfort, Lymphadenopathy, Tenderness
Clinical narrative: A 27 year old male patient received a percutaneous injection of smallpox ACAM2000, (lot number W04003A) on 01 December 2009.  The site of administration was not reported.  One day post-vaccination, the patient experienced chest discomfort for one day.  This was followed by swollen and tender lymph nodes under the left arm which developed 7 days post-vaccination.  The patient recovered.  No additional information was provided.  Note:  There may be a discrepancy between the event date field and the onset date information in the free text narrative field in the data reported.  Latency has been calculated using the event date.  List of documents held by sender: none.
Age: 45.0
Sex: F
Vaccine: SMALL
Symptoms: Biopsy skin, Generalised vaccinia, Rash maculo-papular
Clinical narrative: This case was received on 01 March 2010 via a search on the VAERS database, under reference number 373797. A 45 year old female patient received a percutaneous injection of ACAM2000, lot number W04003A on 02 December 2009. Thirteen days post vaccination, the patient developed a macular-papular rash on both arms and legs. The patient was seen by a Dermatologist and was diagnosed with smallpox vaccination generalized (self limiting). A punch biopsy of the rash was performed and results are pending. No additional information was provided. List of documents held by sender: none.
Age: 22.0
Sex: F
Vaccine: SMALL
Symptoms: Generalised vaccinia
Clinical narrative: This case was received on 01 March 2010 via a QScan search on the VAERS database, under reference number 374214. A 22 year-old female patient received the following vaccine on 11 December 2009: a percutaneous injection of ACAM2000 (lot number VV04-003A). The site of administration was not reported. Five days post ACAM2000 vaccination generalized vaccinia was reported. No additional details were provided. Note- The country of occurrence, the country of the reporter and the country where the patient was vaccinated were not reported. The product was administered by the military and therefore was selected as the occurrence. List of documents held by sender: none.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Generalised vaccinia
Clinical narrative: This case was received on 01 March 2010 via a QScan search on the VAERS database, under reference number 374215. A 25 year old male patient received ACAM2000 (lot number VV04-003A) on 07 December 2009. Eleven days post vaccination, the patient developed generalized vaccina. No additional information was provided. Note- The country of occurrence, the country of the reporter and the country where the patient was vaccinated were not reported. The product was administered by the military and therefore was selected as the of occurrence. List of documents: none.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Asthenia, Malaise, Pain, Post vaccination autoinoculation, Pyrexia
Clinical narrative: This case was received on 01 March 2010 via a QScan search on the VAERS database, under reference number 374783. A 21 year old male patient received a percutaneous injection of ACAM2000 (lot number VV04-003A) on 22 November 2009. The site of vaccination was not reported. One day post-vaccination, the patient experienced auto-inoculation. He developed a pustule secondary to the inoculation site. The patient popped and pustule and 2 additional pustules formed. The patient reported feeling very ill and very weak. He had body aches and light fever (not measured). The patient experienced vomiting (15 episodes). He lost 12 pounds over the course of 2 days. The weight was regained over 5 days. No additional information was provided.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Rash pustular, Vomiting, Weight decreased
Clinical narrative: This case was received on 01 March 2010 via a QScan search on the VAERS database, under reference number 374783. A 21 year old male patient received a percutaneous injection of ACAM2000 (lot number VV04-003A) on 22 November 2009. The site of vaccination was not reported. One day post-vaccination, the patient experienced auto-inoculation. He developed a pustule secondary to the inoculation site. The patient popped and pustule and 2 additional pustules formed. The patient reported feeling very ill and very weak. He had body aches and light fever (not measured). The patient experienced vomiting (15 episodes). He lost 12 pounds over the course of 2 days. The weight was regained over 5 days. No additional information was provided.
Age: 26.0
Sex: F
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Bacterial culture, Blister, Erythema, Herpes simplex serology positive, Paraesthesia
Clinical narrative: This case was received on 10 May 2010 via a QScan search on the VAERS database, under reference number 375785. A 26 year-old female patient received the following vaccines on 08 December 2009: a percutaneous injection of ACAM2000 (lot number not reported); and anthrax vaccine (other manufacturer, lot number FAV219). Nine days after vaccination, the patient developed redness over the nose and cheeks which was followed by tingling and papular lesions around the upper and lower lips. The following day, additional lesions appeared on the forehead, right cheek and left outer ear. There were no oral lesions or painful swallowing. The lesions increased around the lips on Day 10. The patient reports that the ACAM2000 vaccination site remained covered until approximately Day 5 when a vesicle was noted at the site and it remained covered since then. She denies scratching or rubbing the site. The patient was evaluated by dermatology on Day 10. She was afebrile. The lesions at this time were described as follows: multiple grouped papules distributed around upper and lower lip borders, some on erythematous base and some mildly coalesced; 2 papules above upper lip; 1 on left outer ear; 1 on right cheek; 2 on forehead; and a shiny macular plaque across nose and both cheeks. A robust take was noted at the ACAM2000 vaccination site with mild tenderness in the left axillary area. The preliminary diagnosis was possible autoinoculation. VALTREX was prescribed. A viral culture was positive for herpes simplex virus; a bacterial culture was negative; and vaccinia PCR was negative. The patient recovered. NOTE: Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination and the lot number has been verified as an ACAM2000 lot number. List of documents held by sender: none.