chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Scan brain, Spinal X-ray normal
Clinical narrative: This case was received from the Centers for Disease Control and Prevention (CDC) on 11 December 2007 under VAERS reference number 297573. An 18-year-old male patient, with no known medical history, received an intramuscular left arm injection of Menactra (lot number U2278AA) on 22 August 2007. On 18 September 2007, he presented to the student health center with complaints of muscle pain and intermittent tingling in the extremities. He was seen in the health center on 19 September 2007, 20 September 2007, and 21 September 2007, at which time his symptoms were noted to be persistent but unchanged. On 24 September 2007 he complained of weakness in the legs and difficulty swallowing. He was seen in the emergency room, and a CT of the head and x-ray of the cervical spine were normal. He was diagnosed with a neck sprain and discharged the same day. On 25 September 2007 he presented to the health center with increased weakness and neurological changes. He was admitted to the hospital and diagnosed with Guillain-Barre Syndrome (GBS). CSF laboratory findings were as follows: Albumin 103, IgG 19.1, protein 143, WBC's 5-10, RBC (+); cryptococcus antigen negative, culture negative, Lyme negative, HSV (herpes simplex virus) negative, drug screen negative. No virus was isolated. Myelin base protein was 1.5 (reference ranges and units were not provided). Per the treating physician, EMG (electromyogram) and NCS (nerve conduction studies) were positive for GBS. Neurological and infectious disease consults were obtained, and the patient was treated with five doses of intravenous immunoglobulin G. A gradual improvement was noted and the patient was discharged on 01 October 2007. He received occupational and physical therapy at home, and the event resolved. At the time of the report, the event was being evaluated by CISA using the Brighton Collaboration's most recent case definition for Guillain Barre Syndrome.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Blood culture negative, Blood product transfusion, Bradycardia, CSF culture negative, CSF glucose
Clinical narrative: Initial report received on 11 December 2007 from the Centers for Disease Control and Prevention, VAERS# 295191. A 15-year-old female patient with no pre-existing medical history, developed tingling in fingers, a headache and weakness in extremities 12 hours after she had received an intradermal left arm injection of Menactra, lot number U2232AA (incorrect route). The patient had received concomitant immunizations consisting of an intradermal left arm injection of Adacel, lot number C2771AA (incorrect route) and an intradermal right arm injection of HPV (Gardasil), lot number 0927U on 08 August 2007. On 08 August 2007, 12 hours after she had received the vaccines, the patient developed tingling in her fingers, a headache and weakness in her extremities leading to hospitalization 09 August 2007. The patient was admitted to the hospital for Guillain-Barre Syndrome. On 16 November 2007, a review of hospital medical records revealed the patient experienced LE paralysis & paraesthesias the day after vaccination. The patient was hospitalized on 09 August 2007 and an "Intensivist" consult was performed in the emergency room; diagnosis: "probably early GBS". Paralysis had resolved on admittance. Corrective treatment included intravenous immunoglobulin but the patient developed a high fever and tachycardia, and the intravenous immunoglobulin was discontinued. The patient then developed bradycardia which resolved by the next day. Laboratory and diagnostic testing included a CBC and chemistry (WNL), MRI brain & spine (WNL), CSF: glucose (49), protein (40), WBC (0) and RBC (0). Blood and CSF culture negative. The patient was hospitalized for four days and was discharged on 12 August 2007. According to the reporter, the patient had recovered from the event. Neurology consults x2 were performed and neither agreed with the GBS diagnosis. Final diagnosis: acute paralysis of LE's, resolved; reaction to IVIG, resolved; fever, resolved; bradycardia, resolved. The patient was reported as recovered from the event. At the time of the report, the event was being evaluated by CISA as possible Guillain-Barre Syndrome. A second report containing additional information was received from another manufacturer regarding this event, report# WAES 0712USA01241 on 10 December 2007. The initial reporter to this manufacturer had been the FDA (VAERS ID# 295191). The information received was the same as reported by the Centers for Disease Control except for the following differences: routes of administration for each vaccine administered to the patient had not been reported. Daptacel, lot number C2771AA was the name listed as a concomitant vaccination (instead of Adacel). The patient's recovery status was also reported as unknown. No additional information was expected.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: CSF protein normal, CSF white blood cell count, Full blood count normal, Guillain-Barre syndrome, Headache
Clinical narrative: Initial report received on 11 December 2007 from the Centers for Disease Control and Prevention, VAERS# 295191. A 15-year-old female patient with no pre-existing medical history, developed tingling in fingers, a headache and weakness in extremities 12 hours after she had received an intradermal left arm injection of Menactra, lot number U2232AA (incorrect route). The patient had received concomitant immunizations consisting of an intradermal left arm injection of Adacel, lot number C2771AA (incorrect route) and an intradermal right arm injection of HPV (Gardasil), lot number 0927U on 08 August 2007. On 08 August 2007, 12 hours after she had received the vaccines, the patient developed tingling in her fingers, a headache and weakness in her extremities leading to hospitalization 09 August 2007. The patient was admitted to the hospital for Guillain-Barre Syndrome. On 16 November 2007, a review of hospital medical records revealed the patient experienced LE paralysis & paraesthesias the day after vaccination. The patient was hospitalized on 09 August 2007 and an "Intensivist" consult was performed in the emergency room; diagnosis: "probably early GBS". Paralysis had resolved on admittance. Corrective treatment included intravenous immunoglobulin but the patient developed a high fever and tachycardia, and the intravenous immunoglobulin was discontinued. The patient then developed bradycardia which resolved by the next day. Laboratory and diagnostic testing included a CBC and chemistry (WNL), MRI brain & spine (WNL), CSF: glucose (49), protein (40), WBC (0) and RBC (0). Blood and CSF culture negative. The patient was hospitalized for four days and was discharged on 12 August 2007. According to the reporter, the patient had recovered from the event. Neurology consults x2 were performed and neither agreed with the GBS diagnosis. Final diagnosis: acute paralysis of LE's, resolved; reaction to IVIG, resolved; fever, resolved; bradycardia, resolved. The patient was reported as recovered from the event. At the time of the report, the event was being evaluated by CISA as possible Guillain-Barre Syndrome. A second report containing additional information was received from another manufacturer regarding this event, report# WAES 0712USA01241 on 10 December 2007. The initial reporter to this manufacturer had been the FDA (VAERS ID# 295191). The information received was the same as reported by the Centers for Disease Control except for the following differences: routes of administration for each vaccine administered to the patient had not been reported. Daptacel, lot number C2771AA was the name listed as a concomitant vaccination (instead of Adacel). The patient's recovery status was also reported as unknown. No additional information was expected.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Incorrect route of drug administration, Laboratory test normal, Muscular weakness, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Initial report received on 11 December 2007 from the Centers for Disease Control and Prevention, VAERS# 295191. A 15-year-old female patient with no pre-existing medical history, developed tingling in fingers, a headache and weakness in extremities 12 hours after she had received an intradermal left arm injection of Menactra, lot number U2232AA (incorrect route). The patient had received concomitant immunizations consisting of an intradermal left arm injection of Adacel, lot number C2771AA (incorrect route) and an intradermal right arm injection of HPV (Gardasil), lot number 0927U on 08 August 2007. On 08 August 2007, 12 hours after she had received the vaccines, the patient developed tingling in her fingers, a headache and weakness in her extremities leading to hospitalization 09 August 2007. The patient was admitted to the hospital for Guillain-Barre Syndrome. On 16 November 2007, a review of hospital medical records revealed the patient experienced LE paralysis & paraesthesias the day after vaccination. The patient was hospitalized on 09 August 2007 and an "Intensivist" consult was performed in the emergency room; diagnosis: "probably early GBS". Paralysis had resolved on admittance. Corrective treatment included intravenous immunoglobulin but the patient developed a high fever and tachycardia, and the intravenous immunoglobulin was discontinued. The patient then developed bradycardia which resolved by the next day. Laboratory and diagnostic testing included a CBC and chemistry (WNL), MRI brain & spine (WNL), CSF: glucose (49), protein (40), WBC (0) and RBC (0). Blood and CSF culture negative. The patient was hospitalized for four days and was discharged on 12 August 2007. According to the reporter, the patient had recovered from the event. Neurology consults x2 were performed and neither agreed with the GBS diagnosis. Final diagnosis: acute paralysis of LE's, resolved; reaction to IVIG, resolved; fever, resolved; bradycardia, resolved. The patient was reported as recovered from the event. At the time of the report, the event was being evaluated by CISA as possible Guillain-Barre Syndrome. A second report containing additional information was received from another manufacturer regarding this event, report# WAES 0712USA01241 on 10 December 2007. The initial reporter to this manufacturer had been the FDA (VAERS ID# 295191). The information received was the same as reported by the Centers for Disease Control except for the following differences: routes of administration for each vaccine administered to the patient had not been reported. Daptacel, lot number C2771AA was the name listed as a concomitant vaccination (instead of Adacel). The patient's recovery status was also reported as unknown. No additional information was expected.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Paraesthesia, Paralysis, Pyrexia, Tachycardia, Transfusion reaction
Clinical narrative: Initial report received on 11 December 2007 from the Centers for Disease Control and Prevention, VAERS# 295191. A 15-year-old female patient with no pre-existing medical history, developed tingling in fingers, a headache and weakness in extremities 12 hours after she had received an intradermal left arm injection of Menactra, lot number U2232AA (incorrect route). The patient had received concomitant immunizations consisting of an intradermal left arm injection of Adacel, lot number C2771AA (incorrect route) and an intradermal right arm injection of HPV (Gardasil), lot number 0927U on 08 August 2007. On 08 August 2007, 12 hours after she had received the vaccines, the patient developed tingling in her fingers, a headache and weakness in her extremities leading to hospitalization 09 August 2007. The patient was admitted to the hospital for Guillain-Barre Syndrome. On 16 November 2007, a review of hospital medical records revealed the patient experienced LE paralysis & paraesthesias the day after vaccination. The patient was hospitalized on 09 August 2007 and an "Intensivist" consult was performed in the emergency room; diagnosis: "probably early GBS". Paralysis had resolved on admittance. Corrective treatment included intravenous immunoglobulin but the patient developed a high fever and tachycardia, and the intravenous immunoglobulin was discontinued. The patient then developed bradycardia which resolved by the next day. Laboratory and diagnostic testing included a CBC and chemistry (WNL), MRI brain & spine (WNL), CSF: glucose (49), protein (40), WBC (0) and RBC (0). Blood and CSF culture negative. The patient was hospitalized for four days and was discharged on 12 August 2007. According to the reporter, the patient had recovered from the event. Neurology consults x2 were performed and neither agreed with the GBS diagnosis. Final diagnosis: acute paralysis of LE's, resolved; reaction to IVIG, resolved; fever, resolved; bradycardia, resolved. The patient was reported as recovered from the event. At the time of the report, the event was being evaluated by CISA as possible Guillain-Barre Syndrome. A second report containing additional information was received from another manufacturer regarding this event, report# WAES 0712USA01241 on 10 December 2007. The initial reporter to this manufacturer had been the FDA (VAERS ID# 295191). The information received was the same as reported by the Centers for Disease Control except for the following differences: routes of administration for each vaccine administered to the patient had not been reported. Daptacel, lot number C2771AA was the name listed as a concomitant vaccination (instead of Adacel). The patient's recovery status was also reported as unknown. No additional information was expected.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician concerning a 12 week old female with diaper rash who on 01-NOV-2007 was vaccinated PO with her first dose of ROTATEQ (lot# 656379/0505U). Suspect vaccinations administered on that same day included the first dose of PEDIARIX (lot# AC21B124BA) in the right thigh, the first dose of ACTHIB in the left thigh and the first dose of PREVNAR (lot# B47300B) in the left thigh. On 08-NOV-2007 the patient experienced intussusception and was hospitalized (length of stay unknown). On that same day an ultrasound was performed which revealed ileocolic intussusception. Subsequently, the event resolved. The reporter felt that ileocolic intussusception was possibly related to therapy with ROTATEQ, PEDIARIX, ACTHIB and PREVNAR. Ileocolic intussusception was considered to be immediately life-threatening and clinically significant by the physician. No further information is available.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Ultrasound scan abnormal
Clinical narrative: Information has been received from a physician concerning a 12 week old female with diaper rash who on 01-NOV-2007 was vaccinated PO with her first dose of ROTATEQ (lot# 656379/0505U). Suspect vaccinations administered on that same day included the first dose of PEDIARIX (lot# AC21B124BA) in the right thigh, the first dose of ACTHIB in the left thigh and the first dose of PREVNAR (lot# B47300B) in the left thigh. On 08-NOV-2007 the patient experienced intussusception and was hospitalized (length of stay unknown). On that same day an ultrasound was performed which revealed ileocolic intussusception. Subsequently, the event resolved. The reporter felt that ileocolic intussusception was possibly related to therapy with ROTATEQ, PEDIARIX, ACTHIB and PREVNAR. Ileocolic intussusception was considered to be immediately life-threatening and clinically significant by the physician. No further information is available.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Information has been received from a physician concerning a 12 week old female with diaper rash who on 01-NOV-2007 was vaccinated PO with her first dose of ROTATEQ (lot# 656379/0505U). Suspect vaccinations administered on that same day included the first dose of PEDIARIX (lot# AC21B124BA) in the right thigh, the first dose of ACTHIB in the left thigh and the first dose of PREVNAR (lot# B47300B) in the left thigh. On 08-NOV-2007 the patient experienced intussusception and was hospitalized (length of stay unknown). On that same day an ultrasound was performed which revealed ileocolic intussusception. Subsequently, the event resolved. The reporter felt that ileocolic intussusception was possibly related to therapy with ROTATEQ, PEDIARIX, ACTHIB and PREVNAR. Ileocolic intussusception was considered to be immediately life-threatening and clinically significant by the physician. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Dizziness, Headache, Hypoaesthesia, Laboratory test, Muscular weakness
Clinical narrative: Information has been received from a company representative who reported that a local television network interviewed a 15 year old female who on 29-JAN-2008, was vaccinated with a first dose of Gardasil. Within an hour, the patient developed seizures. Per the representative, the patient was brought into the emergency room but it wasn't mentioned if the patient was admitted to the hospital. At the time of the interview on 26-FEB-2008 she was "on walker" and her body was trembling. Laboratory diagnostic studies included a cat scan (results not reported). The patient's seizures and body was trembling persisted. No product quality complaint was involved. Additional information regarding the patient's interview indicated that the patient stated "I can't do the stuff I love which is dancing and playing soccer. It's changed my life so much. I'm not able to walk." According to the patient's mother "When she's walking she's shaking a lot. It feels like her legs have absolutely no strength. The moment she stands up she wants to fall." The patient received Gardasil on 29-JAN-2008 and her symptoms began an hour afterward. According to her mother the symptoms included shaking and tremors. She was rushed to the emergency room but after a series of tests the results were inconclusive. The hospital did a cat scan and a lot of blood work and everything came back normal. It was reported that the doctor on call was concerned because he didn't know what was happening. It was reported that the patient is now being home schooled. Her mother says that she continued to visit doctors, physical therapists and neurologists but no answers have been found. The patient stated that she misses a lot of school. Seizures and body was trembling and shaking were considered to be disabling. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Nausea, Pyrexia, Tremor
Clinical narrative: Information has been received from a company representative who reported that a local television network interviewed a 15 year old female who on 29-JAN-2008, was vaccinated with a first dose of Gardasil. Within an hour, the patient developed seizures. Per the representative, the patient was brought into the emergency room but it wasn't mentioned if the patient was admitted to the hospital. At the time of the interview on 26-FEB-2008 she was "on walker" and her body was trembling. Laboratory diagnostic studies included a cat scan (results not reported). The patient's seizures and body was trembling persisted. No product quality complaint was involved. Additional information regarding the patient's interview indicated that the patient stated "I can't do the stuff I love which is dancing and playing soccer. It's changed my life so much. I'm not able to walk." According to the patient's mother "When she's walking she's shaking a lot. It feels like her legs have absolutely no strength. The moment she stands up she wants to fall." The patient received Gardasil on 29-JAN-2008 and her symptoms began an hour afterward. According to her mother the symptoms included shaking and tremors. She was rushed to the emergency room but after a series of tests the results were inconclusive. The hospital did a cat scan and a lot of blood work and everything came back normal. It was reported that the doctor on call was concerned because he didn't know what was happening. It was reported that the patient is now being home schooled. Her mother says that she continued to visit doctors, physical therapists and neurologists but no answers have been found. The patient stated that she misses a lot of school. Seizures and body was trembling and shaking were considered to be disabling. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Activities of daily living impaired, Blood test, Computerised tomogram, Convulsion, Gait disturbance
Clinical narrative: Information has been received from a company representative who reported that a local television network interviewed a 15 year old female who on 29-JAN-2008, was vaccinated with a first dose of Gardasil. Within an hour, the patient developed seizures. Per the representative, the patient was brought into the emergency room but it wasn't mentioned if the patient was admitted to the hospital. At the time of the interview on 26-FEB-2008 she was "on walker" and her body was trembling. Laboratory diagnostic studies included a cat scan (results not reported). The patient's seizures and body was trembling persisted. No product quality complaint was involved. Additional information regarding the patient's interview indicated that the patient stated "I can't do the stuff I love which is dancing and playing soccer. It's changed my life so much. I'm not able to walk." According to the patient's mother "When she's walking she's shaking a lot. It feels like her legs have absolutely no strength. The moment she stands up she wants to fall." The patient received Gardasil on 29-JAN-2008 and her symptoms began an hour afterward. According to her mother the symptoms included shaking and tremors. She was rushed to the emergency room but after a series of tests the results were inconclusive. The hospital did a cat scan and a lot of blood work and everything came back normal. It was reported that the doctor on call was concerned because he didn't know what was happening. It was reported that the patient is now being home schooled. Her mother says that she continued to visit doctors, physical therapists and neurologists but no answers have been found. The patient stated that she misses a lot of school. Seizures and body was trembling and shaking were considered to be disabling. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Tremor
Clinical narrative: Information has been received from a company representative who reported that a local television network interviewed a 15 year old female who on 29-JAN-2008, was vaccinated with a first dose of Gardasil. Within an hour, the patient developed seizures. Per the representative, the patient was brought into the emergency room but it wasn't mentioned if the patient was admitted to the hospital. At the time of the interview on 26-FEB-2008 she was "on walker" and her body was trembling. Laboratory diagnostic studies included a cat scan (results not reported). The patient's seizures and body was trembling persisted. No product quality complaint was involved. Additional information regarding the patient's interview indicated that the patient stated "I can't do the stuff I love which is dancing and playing soccer. It's changed my life so much. I'm not able to walk." According to the patient's mother "When she's walking she's shaking a lot. It feels like her legs have absolutely no strength. The moment she stands up she wants to fall." The patient received Gardasil on 29-JAN-2008 and her symptoms began an hour afterward. According to her mother the symptoms included shaking and tremors. She was rushed to the emergency room but after a series of tests the results were inconclusive. The hospital did a cat scan and a lot of blood work and everything came back normal. It was reported that the doctor on call was concerned because he didn't know what was happening. It was reported that the patient is now being home schooled. Her mother says that she continued to visit doctors, physical therapists and neurologists but no answers have been found. The patient stated that she misses a lot of school. Seizures and body was trembling and shaking were considered to be disabling. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Blood test normal, Computerised tomogram normal, Convulsion, Dizziness, Headache
Clinical narrative: Information has been received from a company representative who reported that a local television network interviewed a 15 year old female who on 29-JAN-2008, was vaccinated with a first dose of Gardasil. Within an hour, the patient developed seizures. Per the representative, the patient was brought into the emergency room but it wasn't mentioned if the patient was admitted to the hospital. At the time of the interview on 26-FEB-2008 she was "on walker" and her body was trembling. Laboratory diagnostic studies included a cat scan (results not reported). The patient's seizures and body was trembling persisted. No product quality complaint was involved. Additional information regarding the patient's interview indicated that the patient stated "I can't do the stuff I love which is dancing and playing soccer. It's changed my life so much. I'm not able to walk." According to the patient's mother "When she's walking she's shaking a lot. It feels like her legs have absolutely no strength. The moment she stands up she wants to fall." The patient received Gardasil on 29-JAN-2008 and her symptoms began an hour afterward. According to her mother the symptoms included shaking and tremors. She was rushed to the emergency room but after a series of tests the results were inconclusive. The hospital did a cat scan and a lot of blood work and everything came back normal. It was reported that the doctor on call was concerned because he didn't know what was happening. It was reported that the patient is now being home schooled. Her mother says that she continued to visit doctors, physical therapists and neurologists but no answers have been found. The patient stated that she misses a lot of school. Seizures and body was trembling and shaking were considered to be disabling. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Hypoaesthesia, Nuclear magnetic resonance imaging normal, Pain, Paraesthesia, Pyrexia
Clinical narrative: Information has been received from a company representative who reported that a local television network interviewed a 15 year old female who on 29-JAN-2008, was vaccinated with a first dose of Gardasil. Within an hour, the patient developed seizures. Per the representative, the patient was brought into the emergency room but it wasn't mentioned if the patient was admitted to the hospital. At the time of the interview on 26-FEB-2008 she was "on walker" and her body was trembling. Laboratory diagnostic studies included a cat scan (results not reported). The patient's seizures and body was trembling persisted. No product quality complaint was involved. Additional information regarding the patient's interview indicated that the patient stated "I can't do the stuff I love which is dancing and playing soccer. It's changed my life so much. I'm not able to walk." According to the patient's mother "When she's walking she's shaking a lot. It feels like her legs have absolutely no strength. The moment she stands up she wants to fall." The patient received Gardasil on 29-JAN-2008 and her symptoms began an hour afterward. According to her mother the symptoms included shaking and tremors. She was rushed to the emergency room but after a series of tests the results were inconclusive. The hospital did a cat scan and a lot of blood work and everything came back normal. It was reported that the doctor on call was concerned because he didn't know what was happening. It was reported that the patient is now being home schooled. Her mother says that she continued to visit doctors, physical therapists and neurologists but no answers have been found. The patient stated that she misses a lot of school. Seizures and body was trembling and shaking were considered to be disabling. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Tremor, Urine analysis normal
Clinical narrative: Information has been received from a company representative who reported that a local television network interviewed a 15 year old female who on 29-JAN-2008, was vaccinated with a first dose of Gardasil. Within an hour, the patient developed seizures. Per the representative, the patient was brought into the emergency room but it wasn't mentioned if the patient was admitted to the hospital. At the time of the interview on 26-FEB-2008 she was "on walker" and her body was trembling. Laboratory diagnostic studies included a cat scan (results not reported). The patient's seizures and body was trembling persisted. No product quality complaint was involved. Additional information regarding the patient's interview indicated that the patient stated "I can't do the stuff I love which is dancing and playing soccer. It's changed my life so much. I'm not able to walk." According to the patient's mother "When she's walking she's shaking a lot. It feels like her legs have absolutely no strength. The moment she stands up she wants to fall." The patient received Gardasil on 29-JAN-2008 and her symptoms began an hour afterward. According to her mother the symptoms included shaking and tremors. She was rushed to the emergency room but after a series of tests the results were inconclusive. The hospital did a cat scan and a lot of blood work and everything came back normal. It was reported that the doctor on call was concerned because he didn't know what was happening. It was reported that the patient is now being home schooled. Her mother says that she continued to visit doctors, physical therapists and neurologists but no answers have been found. The patient stated that she misses a lot of school. Seizures and body was trembling and shaking were considered to be disabling. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Chills, Electroencephalogram normal, Headache, Inappropriate schedule of drug administration, Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from a company representative who reported that a local television network interviewed a 15 year old female who on 29-JAN-2008, was vaccinated with a first dose of Gardasil. Within an hour, the patient developed seizures. Per the representative, the patient was brought into the emergency room but it wasn't mentioned if the patient was admitted to the hospital. At the time of the interview on 26-FEB-2008 she was "on walker" and her body was trembling. Laboratory diagnostic studies included a cat scan (results not reported). The patient's seizures and body was trembling persisted. No product quality complaint was involved. Additional information regarding the patient's interview indicated that the patient stated "I can't do the stuff I love which is dancing and playing soccer. It's changed my life so much. I'm not able to walk." According to the patient's mother "When she's walking she's shaking a lot. It feels like her legs have absolutely no strength. The moment she stands up she wants to fall." The patient received Gardasil on 29-JAN-2008 and her symptoms began an hour afterward. According to her mother the symptoms included shaking and tremors. She was rushed to the emergency room but after a series of tests the results were inconclusive. The hospital did a cat scan and a lot of blood work and everything came back normal. It was reported that the doctor on call was concerned because he didn't know what was happening. It was reported that the patient is now being home schooled. Her mother says that she continued to visit doctors, physical therapists and neurologists but no answers have been found. The patient stated that she misses a lot of school. Seizures and body was trembling and shaking were considered to be disabling. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Photophobia, Tremor, Urine human chorionic gonadotropin negative
Clinical narrative: Information has been received from a company representative who reported that a local television network interviewed a 15 year old female who on 29-JAN-2008, was vaccinated with a first dose of Gardasil. Within an hour, the patient developed seizures. Per the representative, the patient was brought into the emergency room but it wasn't mentioned if the patient was admitted to the hospital. At the time of the interview on 26-FEB-2008 she was "on walker" and her body was trembling. Laboratory diagnostic studies included a cat scan (results not reported). The patient's seizures and body was trembling persisted. No product quality complaint was involved. Additional information regarding the patient's interview indicated that the patient stated "I can't do the stuff I love which is dancing and playing soccer. It's changed my life so much. I'm not able to walk." According to the patient's mother "When she's walking she's shaking a lot. It feels like her legs have absolutely no strength. The moment she stands up she wants to fall." The patient received Gardasil on 29-JAN-2008 and her symptoms began an hour afterward. According to her mother the symptoms included shaking and tremors. She was rushed to the emergency room but after a series of tests the results were inconclusive. The hospital did a cat scan and a lot of blood work and everything came back normal. It was reported that the doctor on call was concerned because he didn't know what was happening. It was reported that the patient is now being home schooled. Her mother says that she continued to visit doctors, physical therapists and neurologists but no answers have been found. The patient stated that she misses a lot of school. Seizures and body was trembling and shaking were considered to be disabling. No further information is available.
Age: 1.13
Sex: M
Vaccine: HBHEPB, HEPA, MMR, PPV, VARCEL
Symptoms: Abnormal behaviour, Movement disorder, Sensory disturbance, Social avoidant behaviour, Speech disorder
Clinical narrative: Fails to respond to his name. Has poor eye contact. Appears not to hear me at times. He appears unaware of others' feelings. Prefers playing alone  retreats into his "own world".     Loss previously acquired ability to say words or sentences  Does not make eye contact when making requests  uses a singsong voice  Can't start a conversation   Performs repetitive movements, such as rocking and spinning  has specific routines or rituals  he is disturbed at the slightest change in routines or rituals  he moves constantly  he  becomes fascinated by parts of an object, like spinning wheels of a toy car  he can sometimes be sensitive to sound and touch all of started to happen 2 to 3 months after recieving his MMR shot in April of 07
Age: 1.13
Sex: M
Vaccine: HBHEPB, HEPA, MMR, PPV, VARCEL
Symptoms: Staring, Unresponsive to stimuli
Clinical narrative: Fails to respond to his name. Has poor eye contact. Appears not to hear me at times. He appears unaware of others' feelings. Prefers playing alone  retreats into his "own world".     Loss previously acquired ability to say words or sentences  Does not make eye contact when making requests  uses a singsong voice  Can't start a conversation   Performs repetitive movements, such as rocking and spinning  has specific routines or rituals  he is disturbed at the slightest change in routines or rituals  he moves constantly  he  becomes fascinated by parts of an object, like spinning wheels of a toy car  he can sometimes be sensitive to sound and touch all of started to happen 2 to 3 months after recieving his MMR shot in April of 07
Age: 53.0
Sex: M
Vaccine: DTAP
Symptoms: Biopsy skin abnormal, Complement factor decreased, Dermatitis, Dysaesthesia, Erythema
Clinical narrative: Seriousness criteria: Other-Medically Significant Initial report received on 05 March 2008 regarding a literature article. Verbatim from the case report. "A 53-year-old man received DTaP vaccine (dosage not stated). On day 8 following vaccination, he presented with progressive shoulder pain, localized dermatitis and dysesthesias in his vaccinated arm. An examination of his left deltoid area revealed several raised oedematous and erythematous plaques. Some plaques had central papulovesicular changes. He had mild aggravation of his left forearm/wrist area with a left nerve root tension sign. These symptoms were consistent with mild brachial neuritis. His CH50 level was 14 U/mL. A punch biopsy revealed vascular changes that were consistent with small vessel vasculitis. [Patient outcome not stated.]"
Age: 53.0
Sex: M
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration, Limb discomfort, Musculoskeletal pain, Nerve injury, Nerve root injury
Clinical narrative: Seriousness criteria: Other-Medically Significant Initial report received on 05 March 2008 regarding a literature article. Verbatim from the case report. "A 53-year-old man received DTaP vaccine (dosage not stated). On day 8 following vaccination, he presented with progressive shoulder pain, localized dermatitis and dysesthesias in his vaccinated arm. An examination of his left deltoid area revealed several raised oedematous and erythematous plaques. Some plaques had central papulovesicular changes. He had mild aggravation of his left forearm/wrist area with a left nerve root tension sign. These symptoms were consistent with mild brachial neuritis. His CH50 level was 14 U/mL. A punch biopsy revealed vascular changes that were consistent with small vessel vasculitis. [Patient outcome not stated.]"
Age: 53.0
Sex: M
Vaccine: DTAP
Symptoms: Oedema peripheral, Radiculitis brachial, Rash papular, Skin plaque, Vasculitis
Clinical narrative: Seriousness criteria: Other-Medically Significant Initial report received on 05 March 2008 regarding a literature article. Verbatim from the case report. "A 53-year-old man received DTaP vaccine (dosage not stated). On day 8 following vaccination, he presented with progressive shoulder pain, localized dermatitis and dysesthesias in his vaccinated arm. An examination of his left deltoid area revealed several raised oedematous and erythematous plaques. Some plaques had central papulovesicular changes. He had mild aggravation of his left forearm/wrist area with a left nerve root tension sign. These symptoms were consistent with mild brachial neuritis. His CH50 level was 14 U/mL. A punch biopsy revealed vascular changes that were consistent with small vessel vasculitis. [Patient outcome not stated.]"
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Clinical narrative: Information has been received from a physician, concerning a 15 year old female patient with "some baseline hypotonia," who on 02-JUL-2007 was vaccinated with the third dose of Gardasil (route, site and lot # not reported).  Concomitant vaccine therapy at the visit included a dose of MENACTRA.  In October 2007, "the patient experienced an adverse reaction," described as Guillain Barre syndrome (GBS)-type symptoms.  She was hospitalized in an intensive care unit for 3 weeks though no diagnosis was made during that time.  The patient was then transferred to an inpatient rehabilitation center for "about 3 months."  The reporting physician stated the patient just became her patient within the past week and a half.  She stated that the patient had not yet fully recovered, and was currently undergoing outpatient rehabilitation.  Additional information has been requested. 04/07/08-records received for DOS 10/27-11/6/07- DX DC: Weakness, elevated ANA. Presented with 1-2 months of neurological symptoms which began as diffuse mild back pain for 2 months, aching, then 2-3 weeks ago experienced heaviness of limbs, particularly her upper arms and upper legs, non-painful tingling but no numbness. Muslces feel achy all over. Diffuse headache. Mild nausea. Neck pain and siffness times 1 week. General feeling of fatigue and malaise. Weakness progressing from proximal to distal extremities. Unable to walk independently. Short of breath with mild exertion. Lightheaded when standing up. Diplopia. Poor appetite. Constipated for 1 week.  Thought to have a significant psychiatric component to current presentation. Tensilon test no improvement in strength.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Premature labour
Clinical narrative: Information has been received from a physician's assistant concerning a 16 year old female with pertinent medical history and drug reaction/allergies reported as none who on 21-SEP-2007 was vaccinated with the first dose of Gardasil (lot#658222/0927U), 0.5 ml, IM in the left deltoid. Concomitant medication was not reported. On 08-OCT-2007, the patient told the physician's assistant that she was 7 1/2 months pregnant. In approximately October 2007 (date unspecified), the patient was hospitalized and delivered the baby. The patient reported that the delivery was preterm, but no problems were reported. The physician's assistant reported that there were no known problems with the baby or mother. On 04-DEC-2007 (about 6 to 8 weeks) after the patient delivered the baby, the patient received the second dose of Gardasil (lot#657868/0523U) and a dose of MENACTRA. The physician's assistant was not following the pregnancy, only providing the vaccinations. Subsequently on an unspecified date, the patient recovered from the events. No product quality complaint was involved. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Complication of delivery, Drug exposure during pregnancy, Foetal disorder, Labour complication
Clinical narrative: Initial and follow up information has been received via the Merck pregnancy registry, from a registered nurse, concerning an 18 year old female with no known allergies and a history of chlamydial infection (2006), who on 27-NOV-2006 was vaccinated IM in the left arm, with the first dose, 0.5ml, of Gardasil (Lot #653937/0637F), and on 29-JAN-2007 with the second dose, IM in the left arm, 0.5ml, of Gardasil (Lot #655617/1447F). On 30-APR-2007, the patient presented to the office, and a urine pregnancy test performed was positive; other labwork was within normal range. The patient reported a questionable LMP date of 09-APR-2007, with an estimated date of delivery of 14-JAN-2008. Follow up information included that on 30-APR-2007, prenatal vitamins (PRIMACARE ONE) were initiated. On 04-OCT-2007, an ultrasound was performed for routine prenatal care (result not specified). There were no illnesses or infections during pregnancy. The patient experienced complications during labor and delivery, due to uterine atony and a non-reassuring fetal heart rate and a Cesarean section was required; however, on 28-DEC-2007, at 41 weeks gestation, she delivered a normal female infant (no abnormalities and no congenital anomalies), weight 8 lb 1oz, Apgar score 8/9. Upon internal review, non-reassuring fetal heart rate and uterine atony were considered to be serious as other important medical events. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan, Urine human chorionic gonadotropin positive, Uterine atony
Clinical narrative: Initial and follow up information has been received via the Merck pregnancy registry, from a registered nurse, concerning an 18 year old female with no known allergies and a history of chlamydial infection (2006), who on 27-NOV-2006 was vaccinated IM in the left arm, with the first dose, 0.5ml, of Gardasil (Lot #653937/0637F), and on 29-JAN-2007 with the second dose, IM in the left arm, 0.5ml, of Gardasil (Lot #655617/1447F). On 30-APR-2007, the patient presented to the office, and a urine pregnancy test performed was positive; other labwork was within normal range. The patient reported a questionable LMP date of 09-APR-2007, with an estimated date of delivery of 14-JAN-2008. Follow up information included that on 30-APR-2007, prenatal vitamins (PRIMACARE ONE) were initiated. On 04-OCT-2007, an ultrasound was performed for routine prenatal care (result not specified). There were no illnesses or infections during pregnancy. The patient experienced complications during labor and delivery, due to uterine atony and a non-reassuring fetal heart rate and a Cesarean section was required; however, on 28-DEC-2007, at 41 weeks gestation, she delivered a normal female infant (no abnormalities and no congenital anomalies), weight 8 lb 1oz, Apgar score 8/9. Upon internal review, non-reassuring fetal heart rate and uterine atony were considered to be serious as other important medical events. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Convulsion, Syncope
Clinical narrative: Information has been received from a physician concerning a 17 year old female with no pertinent medical history or drug reactions/allergies who on an unspecified date was vaccinated with Gardasil 0.5 mL IM.  Concomitant therapy on the same day included influenza virus vaccine (unspecified).  Subsequently after receiving the Gardasil vaccine, the patient fainted and convulsed.  The patient was administered smelling salts, was revived and went home.  No additional information was given.  The patient recovered on the same day.  Upon internal review the convulsion was considered to be an other medical event.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Laboratory test, Pregnancy test positive
Clinical narrative: Information has been received for the Merck Pregnancy Registry for Gardasil from a licensed practical nurse concerning a 20 year old female with a history of 2 pregnancies and 0 live births (2 miscarriages) who on 18-DEC-2007 was vaccinated with Gardasil (lot# 654540/1209U).  The patient's date of last menstrual period was 18-DEC-2007.  Subsequently the patient became pregnant.  On 04-FEB-2008 the patient experienced a spontaneous abortion.  On 04-FEB-2008, a pregnancy quantitative was < 5.0.  On 21-FEB-2008 the patient was vaccinated with a second dose of Gardasil (lot# 0530U).  Upon internal review spontaneous abortion is considered to be an other medical event.  Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Postpartum depression, Pregnancy test
Clinical narrative: Information has been received from a medical assistant concerning a 16 year old female, who on 01-JUN-2007 was vaccinated IM with a 0.5mL first dose of Gardasil.  Concomitant suspect therapy included motelukast sodium.  Other concomitant therapies included ZYRTEC, albuterol, ADVAIR, HISTUSSIN D, AMOXIL and prednisone.  On 19-AUG-2007 the patient was vaccinated with a second dose of Gardasil.  On 01-SEP-2007 the patient found out that she was thirty weeks pregnant.  The patient was seen at the office.  A pregnancy test was performed at home and in the office.  The patient's last menstrual period was approximately in February 2007 and her estimated delivery date was in November 2007.  The patient gave birth in November 2007.  On 08-NOV-2007 the patient was hospitalized due to postpartum depression.  At the time of the report, the outcomes of the patient and the baby were unknown.  Additional information has been requested.