chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Joint range of motion decreased
Clinical narrative: by 4pm he had "excruciating" pain in the arm from site of inj. to elbow, sl. erythema, no swelling, afebrile. pain was constant, sharp,  >10 on pain scale. pain then radiated across shoulder to mid-chest and mid-back on the left side. experienced shortness of breath when lying supine. slept in lounger. couldn't raise arm until about 48 hours later. developed a bruise of 2"x6" at inj. site. took tylenol for the pain over the weekend. site is still discolored, reddish/purple.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Ecchymosis, Injection site pain
Clinical narrative: Large area of ecchymosis beginning within 1-2 days of injection.  Now at 1 month from injection has persistent aching pain and tenderness in triceps and deltoid muscles underlying injection site.  No palpable mass, abscess or other abnormality.  No neurologic changes in arm
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: REDNESS OF RIGHT DELTOID WITH INDURATION AND WARM TO THE TOUCH.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Asthenia, Dysarthria, Guillain-Barre syndrome, Hypoaesthesia, Nerve conduction studies abnormal
Clinical narrative: Initial report received on 22-SEP-2006 from the Centers for Disease Control and Prevention (CDC, VAERS report number 258422-1). An 18-year-old female patient had received an intramuscular, left arm, first dose injection of MENACTRA, lot # U02050AA (not a valid manufacturer lot number) on 22-MAY-2006. Fifteen days later, she experienced foot and hand numbness. She also developed progressive leg weakness and slurred speech. Nerve conduction studies were performed by a neurologist (results not provided). The patient was subsequently diagnosed with Guillain Barre Syndrome. The event required hospitalization. At the time of this report, recovery status was unknown. As per the CDC this case was confirmed by CISA (Clinical Immunization Safety Assessment network) as being Guillain Barre Syndrome following MENACTRA vaccination.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Dysarthria, Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness
Clinical narrative: Initial report received on 22-SEP-2006 from the Centers for Disease Control and Prevention (CDC, VAERS report number 258422-1). An 18-year-old female patient had received an intramuscular, left arm, first dose injection of MENACTRA, lot # U02050AA (not a valid manufacturer lot number) on 22-MAY-2006. Fifteen days later, she experienced foot and hand numbness. She also developed progressive leg weakness and slurred speech. Nerve conduction studies were performed by a neurologist (results not provided). The patient was subsequently diagnosed with Guillain Barre Syndrome. The event required hospitalization. At the time of this report, recovery status was unknown. As per the CDC this case was confirmed by CISA (Clinical Immunization Safety Assessment network) as being Guillain Barre Syndrome following MENACTRA vaccination.
Age: 43.0
Sex: M
Vaccine: FLUX, HEPAB, IPV, MMR, MNQ, TYP, YF, FLUX, HEPAB, IPV, MNQ, TYP, YF
Symptoms: Asthenia, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Movement disorder
Clinical narrative: Initial report received on 22/Sep/2006 and 25/Sep/2006 from the agency. A 43-year-old male patient with no current illnesses, but who was taking ibuprofen, Ambien and Vicodin had received a dose of Menatra, Influenza vaccine, Yellow Fever vaccine, Poliomyelitis Inactivated vaccine, Typhoid vaccine, Hepatitis A vaccine, and Measles Mumps and Rubella vaccine on 02/Jun/2006. The trade names, manufacturer names, lot numbers, routes and sites of administration were not reported. Eleven days post-immunization, on 13/Jun/2006, the patient felt like there was a mass in his throat, then he had numbness in his fingers and toes. Subsequently, the patient started having difficulty in his gait that was followed by weakness making him unable to lift weights in the gym. Seven days later, on 20/Jun/2006, the patient was hospitalized and treated with IVIG and a dose of Prednisolone. An MRI scan was normal,and per the reporter the patient had RBC'S O, WBC's 2, protein 100, and glucose 64. The patient had an "IGG level 6/2 IVP in am". The patient had received a dose of Hepatitis B vaccine, four weeks prior to administration of vaccines on 02/Jun/2006. The trade name, manufacturer name, lot number , route and site of administration were not reported. At the time of this report,the patient had not recovered from the adverse events. As per the agency this case was confirmed by CISA as being Guillain Barre Syndrome following Menactra vaccine. Follow-up information received on 27/Sep/06 from the agency. The Hepatitis A vaccine and Hepatitis B vaccine that was administered was identified as Twinrix,manufacturer reported, lot number not reported. The patient had been examined in an emergency room on 18/Jun/2006. He was hospitalized from 19/Jun/2006 to 26/Jun/2006. At the time of discharge from the hospital, the patient had increased strength and was able to return home.
Age: 43.0
Sex: M
Vaccine: FLUX, HEPAB, IPV, MMR, MNQ, TYP, YF, FLUX, HEPAB, IPV, MNQ, TYP, YF
Symptoms: Throat tightness
Clinical narrative: Initial report received on 22/Sep/2006 and 25/Sep/2006 from the agency. A 43-year-old male patient with no current illnesses, but who was taking ibuprofen, Ambien and Vicodin had received a dose of Menatra, Influenza vaccine, Yellow Fever vaccine, Poliomyelitis Inactivated vaccine, Typhoid vaccine, Hepatitis A vaccine, and Measles Mumps and Rubella vaccine on 02/Jun/2006. The trade names, manufacturer names, lot numbers, routes and sites of administration were not reported. Eleven days post-immunization, on 13/Jun/2006, the patient felt like there was a mass in his throat, then he had numbness in his fingers and toes. Subsequently, the patient started having difficulty in his gait that was followed by weakness making him unable to lift weights in the gym. Seven days later, on 20/Jun/2006, the patient was hospitalized and treated with IVIG and a dose of Prednisolone. An MRI scan was normal,and per the reporter the patient had RBC'S O, WBC's 2, protein 100, and glucose 64. The patient had an "IGG level 6/2 IVP in am". The patient had received a dose of Hepatitis B vaccine, four weeks prior to administration of vaccines on 02/Jun/2006. The trade name, manufacturer name, lot number , route and site of administration were not reported. At the time of this report,the patient had not recovered from the adverse events. As per the agency this case was confirmed by CISA as being Guillain Barre Syndrome following Menactra vaccine. Follow-up information received on 27/Sep/06 from the agency. The Hepatitis A vaccine and Hepatitis B vaccine that was administered was identified as Twinrix,manufacturer reported, lot number not reported. The patient had been examined in an emergency room on 18/Jun/2006. He was hospitalized from 19/Jun/2006 to 26/Jun/2006. At the time of discharge from the hospital, the patient had increased strength and was able to return home.
Age: 43.0
Sex: M
Vaccine: FLUX, HEPAB, IPV, MMR, MNQ, TYP, YF, FLUX, HEPAB, IPV, MNQ, TYP, YF
Symptoms: Asthenia, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Throat tightness
Clinical narrative: Initial report received on 22/Sep/2006 and 25/Sep/2006 from the agency. A 43-year-old male patient with no current illnesses, but who was taking ibuprofen, Ambien and Vicodin had received a dose of Menatra, Influenza vaccine, Yellow Fever vaccine, Poliomyelitis Inactivated vaccine, Typhoid vaccine, Hepatitis A vaccine, and Measles Mumps and Rubella vaccine on 02/Jun/2006. The trade names, manufacturer names, lot numbers, routes and sites of administration were not reported. Eleven days post-immunization, on 13/Jun/2006, the patient felt like there was a mass in his throat, then he had numbness in his fingers and toes. Subsequently, the patient started having difficulty in his gait that was followed by weakness making him unable to lift weights in the gym. Seven days later, on 20/Jun/2006, the patient was hospitalized and treated with IVIG and a dose of Prednisolone. An MRI scan was normal,and per the reporter the patient had RBC'S O, WBC's 2, protein 100, and glucose 64. The patient had an "IGG level 6/2 IVP in am". The patient had received a dose of Hepatitis B vaccine, four weeks prior to administration of vaccines on 02/Jun/2006. The trade name, manufacturer name, lot number , route and site of administration were not reported. At the time of this report,the patient had not recovered from the adverse events. As per the agency this case was confirmed by CISA as being Guillain Barre Syndrome following Menactra vaccine. Follow-up information received on 27/Sep/06 from the agency. The Hepatitis A vaccine and Hepatitis B vaccine that was administered was identified as Twinrix,manufacturer reported, lot number not reported. The patient had been examined in an emergency room on 18/Jun/2006. He was hospitalized from 19/Jun/2006 to 26/Jun/2006. At the time of discharge from the hospital, the patient had increased strength and was able to return home.
Age: 17.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Blood product transfusion, Deafness, Deafness neurosensory, Guillain-Barre syndrome, Guillain-Barre syndrome
Clinical narrative: Initial information received from the agency on 22/Sep/2006. This case was initially reported by a health care professional. A 17-year-old male patient received an initial dose of Menactra vaccine, lot number U1875AA, administered in the left deltoid on 07/Jul/2006. The route of administration was not reported. Sometime later that same month (exact onset date illegible), the patient had a ten day progression of ascending paralysis. He was diagnosed with Guillain-Barre Syndrome (GBS). The patient was hospitalized and the reporter considered the events to be life-threatening. The patient responded well to treatment with intravenous immunoglobulins (IVIG). His recovery status was reported as unknown. As per the agency this case was confirmes by CISA as being Guillain-Barre Syndrome following Menactra vaccination. Follow-up information was received on 27/Sep/2006 from the agency. Per the reporter, the patient had additional past history of ADHD (Attention Deficit Hyperactivity Disorder). Concomitant medications included Advair, Flonase, Zyrtec, Concerta and albuterol. The patient first experienced symptoms of GBS on 16/Jul/2006, nine days post-immunization. He was subsequently hospitalized ten days later, on 26/Jul/2006 and discharged three days after admission on 29/Jul/2006. The recovery status of the patient unknown.
Age: 17.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Paralysis, Peripheral sensory neuropathy
Clinical narrative: Initial information received from the agency on 22/Sep/2006. This case was initially reported by a health care professional. A 17-year-old male patient received an initial dose of Menactra vaccine, lot number U1875AA, administered in the left deltoid on 07/Jul/2006. The route of administration was not reported. Sometime later that same month (exact onset date illegible), the patient had a ten day progression of ascending paralysis. He was diagnosed with Guillain-Barre Syndrome (GBS). The patient was hospitalized and the reporter considered the events to be life-threatening. The patient responded well to treatment with intravenous immunoglobulins (IVIG). His recovery status was reported as unknown. As per the agency this case was confirmes by CISA as being Guillain-Barre Syndrome following Menactra vaccination. Follow-up information was received on 27/Sep/2006 from the agency. Per the reporter, the patient had additional past history of ADHD (Attention Deficit Hyperactivity Disorder). Concomitant medications included Advair, Flonase, Zyrtec, Concerta and albuterol. The patient first experienced symptoms of GBS on 16/Jul/2006, nine days post-immunization. He was subsequently hospitalized ten days later, on 26/Jul/2006 and discharged three days after admission on 29/Jul/2006. The recovery status of the patient unknown.
Age: 17.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Guillain-Barre syndrome, Paralysis
Clinical narrative: Initial information received from the agency on 22/Sep/2006. This case was initially reported by a health care professional. A 17-year-old male patient received an initial dose of Menactra vaccine, lot number U1875AA, administered in the left deltoid on 07/Jul/2006. The route of administration was not reported. Sometime later that same month (exact onset date illegible), the patient had a ten day progression of ascending paralysis. He was diagnosed with Guillain-Barre Syndrome (GBS). The patient was hospitalized and the reporter considered the events to be life-threatening. The patient responded well to treatment with intravenous immunoglobulins (IVIG). His recovery status was reported as unknown. As per the agency this case was confirmes by CISA as being Guillain-Barre Syndrome following Menactra vaccination. Follow-up information was received on 27/Sep/2006 from the agency. Per the reporter, the patient had additional past history of ADHD (Attention Deficit Hyperactivity Disorder). Concomitant medications included Advair, Flonase, Zyrtec, Concerta and albuterol. The patient first experienced symptoms of GBS on 16/Jul/2006, nine days post-immunization. He was subsequently hospitalized ten days later, on 26/Jul/2006 and discharged three days after admission on 29/Jul/2006. The recovery status of the patient unknown.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ, TDAP
Symptoms: CSF test abnormal, Guillain-Barre syndrome
Clinical narrative: Initial report received on 22/Sep/2006 from the agency. An 11-year-old female patient whop had no current illnesses and no pre-existing medical conditions had received her first subcutaneous dose of Menactra, lot number U1809AA, in the right arm, and her first intra-muscular dose Boostrix (manufacturer), lot number AC25200, in the left arm on 30/Jun/2006. A subcutaneous injection of Menactra is not recommended route of administration by the manufacturer. Thirty-four days post-immunization, the patient developed Guillain-Barre Syndrome and was hospitalized for seven days. A lumbar puncture with CSF showed protein 77, and and EMG was consistent with Guillain-Barre Syndrome. The patient's twin sibling also had the same vaccine and experienced no problems. At the time of this report, the patient had not recovered from this serious adverse event. As per the agency this case was confirmed by CISA as being Guillain-Barre Syndrome following Menactra vaccination. Follow-up information received on 27/Sep/2006 from the agency. The onset of the first symptoms was reported as 01/Aug/2006, "33 days" post-immunization. The patient had been hospitalized from 07/Aug/2006 to 14/Aug/2006. She had a second hospitalization from 21/Aug/2006 to 28/Aug/2006. She was discharged on 28/Aug/2006 to a rehabilitation unit.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ, TDAP
Symptoms: Guillain-Barre syndrome
Clinical narrative: Initial report received on 22/Sep/2006 from the agency. An 11-year-old female patient whop had no current illnesses and no pre-existing medical conditions had received her first subcutaneous dose of Menactra, lot number U1809AA, in the right arm, and her first intra-muscular dose Boostrix (manufacturer), lot number AC25200, in the left arm on 30/Jun/2006. A subcutaneous injection of Menactra is not recommended route of administration by the manufacturer. Thirty-four days post-immunization, the patient developed Guillain-Barre Syndrome and was hospitalized for seven days. A lumbar puncture with CSF showed protein 77, and and EMG was consistent with Guillain-Barre Syndrome. The patient's twin sibling also had the same vaccine and experienced no problems. At the time of this report, the patient had not recovered from this serious adverse event. As per the agency this case was confirmed by CISA as being Guillain-Barre Syndrome following Menactra vaccination. Follow-up information received on 27/Sep/2006 from the agency. The onset of the first symptoms was reported as 01/Aug/2006, "33 days" post-immunization. The patient had been hospitalized from 07/Aug/2006 to 14/Aug/2006. She had a second hospitalization from 21/Aug/2006 to 28/Aug/2006. She was discharged on 28/Aug/2006 to a rehabilitation unit.
Age: 30.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Asthenia, Back pain, Blood glucose normal, CSF cell count, CSF oligoclonal band absent
Clinical narrative: Initial report received on 22/Sep/2006 from the agency. A 30-year-old male patient with no current illnesses had received a first intra-muscular dose of Menatra, lot number U2068AA, in the left arm on 31/Jul/2006. Nine days post-immunization, the patient developed tingling in his feet and face, as well as low back pain. The patient presented to the hospital and was sent home. His symptoms continued and he began to complain of weakness in his lower extremities. The follow day, the patient presented to the emergency room and was admitted. CSF showed RBC's 1, WBC's 0, Protein 92, Glucose 73, and Oligoclonal bands were negative. A CT without contrast was normal, ESR was normal, and an MRI of the L5 spine showed mild degenerative disc changes. A Drug/ETOH screen was negative. An EMG was complete and was consistent with demyelinating process. The patient's vital capacity was 1.4-1.5 liters, and a stool for campylobacter jejuni was still pending at the time of this report. The patient subsequently developed dysphagia to solid foods, but has not had any respiratory compromise. At the time of this report to agency, the patient was still hospitalized. As per the agency this case has not been confirmed by CISA as being Guillain Barre Syndrome following Menactra vaccinations. Follow-up information received on 27/Sep/2006 from the agency. Per the reported information, "this case is almost certainly Guillain Barre Syndrome. There is electrophysiologic and CSF confirmation. The only Guillain Barre criterion that there was not information on was myotactic reflexes'. The patient was hospitalized from 11/Aug/2006 to 28/Aug/2006 and then discharged to a rehabilitation unit.  Follow-Up Info: Patient went to Rehab Facility and made complete recovery in 4 weeks,
Age: 30.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Dysphagia, Electromyogram normal, Guillain-Barre syndrome, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Initial report received on 22/Sep/2006 from the agency. A 30-year-old male patient with no current illnesses had received a first intra-muscular dose of Menatra, lot number U2068AA, in the left arm on 31/Jul/2006. Nine days post-immunization, the patient developed tingling in his feet and face, as well as low back pain. The patient presented to the hospital and was sent home. His symptoms continued and he began to complain of weakness in his lower extremities. The follow day, the patient presented to the emergency room and was admitted. CSF showed RBC's 1, WBC's 0, Protein 92, Glucose 73, and Oligoclonal bands were negative. A CT without contrast was normal, ESR was normal, and an MRI of the L5 spine showed mild degenerative disc changes. A Drug/ETOH screen was negative. An EMG was complete and was consistent with demyelinating process. The patient's vital capacity was 1.4-1.5 liters, and a stool for campylobacter jejuni was still pending at the time of this report. The patient subsequently developed dysphagia to solid foods, but has not had any respiratory compromise. At the time of this report to agency, the patient was still hospitalized. As per the agency this case has not been confirmed by CISA as being Guillain Barre Syndrome following Menactra vaccinations. Follow-up information received on 27/Sep/2006 from the agency. Per the reported information, "this case is almost certainly Guillain Barre Syndrome. There is electrophysiologic and CSF confirmation. The only Guillain Barre criterion that there was not information on was myotactic reflexes'. The patient was hospitalized from 11/Aug/2006 to 28/Aug/2006 and then discharged to a rehabilitation unit.  Follow-Up Info: Patient went to Rehab Facility and made complete recovery in 4 weeks,
Age: 30.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Protein total, Stool analysis, White blood cell count
Clinical narrative: Initial report received on 22/Sep/2006 from the agency. A 30-year-old male patient with no current illnesses had received a first intra-muscular dose of Menatra, lot number U2068AA, in the left arm on 31/Jul/2006. Nine days post-immunization, the patient developed tingling in his feet and face, as well as low back pain. The patient presented to the hospital and was sent home. His symptoms continued and he began to complain of weakness in his lower extremities. The follow day, the patient presented to the emergency room and was admitted. CSF showed RBC's 1, WBC's 0, Protein 92, Glucose 73, and Oligoclonal bands were negative. A CT without contrast was normal, ESR was normal, and an MRI of the L5 spine showed mild degenerative disc changes. A Drug/ETOH screen was negative. An EMG was complete and was consistent with demyelinating process. The patient's vital capacity was 1.4-1.5 liters, and a stool for campylobacter jejuni was still pending at the time of this report. The patient subsequently developed dysphagia to solid foods, but has not had any respiratory compromise. At the time of this report to agency, the patient was still hospitalized. As per the agency this case has not been confirmed by CISA as being Guillain Barre Syndrome following Menactra vaccinations. Follow-up information received on 27/Sep/2006 from the agency. Per the reported information, "this case is almost certainly Guillain Barre Syndrome. There is electrophysiologic and CSF confirmation. The only Guillain Barre criterion that there was not information on was myotactic reflexes'. The patient was hospitalized from 11/Aug/2006 to 28/Aug/2006 and then discharged to a rehabilitation unit.  Follow-Up Info: Patient went to Rehab Facility and made complete recovery in 4 weeks,
Age: 30.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Back pain, CSF protein increased, CSF test abnormal, Computerised tomogram normal, Demyelination
Clinical narrative: Initial report received on 22/Sep/2006 from the agency. A 30-year-old male patient with no current illnesses had received a first intra-muscular dose of Menatra, lot number U2068AA, in the left arm on 31/Jul/2006. Nine days post-immunization, the patient developed tingling in his feet and face, as well as low back pain. The patient presented to the hospital and was sent home. His symptoms continued and he began to complain of weakness in his lower extremities. The follow day, the patient presented to the emergency room and was admitted. CSF showed RBC's 1, WBC's 0, Protein 92, Glucose 73, and Oligoclonal bands were negative. A CT without contrast was normal, ESR was normal, and an MRI of the L5 spine showed mild degenerative disc changes. A Drug/ETOH screen was negative. An EMG was complete and was consistent with demyelinating process. The patient's vital capacity was 1.4-1.5 liters, and a stool for campylobacter jejuni was still pending at the time of this report. The patient subsequently developed dysphagia to solid foods, but has not had any respiratory compromise. At the time of this report to agency, the patient was still hospitalized. As per the agency this case has not been confirmed by CISA as being Guillain Barre Syndrome following Menactra vaccinations. Follow-up information received on 27/Sep/2006 from the agency. Per the reported information, "this case is almost certainly Guillain Barre Syndrome. There is electrophysiologic and CSF confirmation. The only Guillain Barre criterion that there was not information on was myotactic reflexes'. The patient was hospitalized from 11/Aug/2006 to 28/Aug/2006 and then discharged to a rehabilitation unit.  Follow-Up Info: Patient went to Rehab Facility and made complete recovery in 4 weeks,
Age: 30.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Dysphagia, Guillain-Barre syndrome, Intervertebral disc degeneration, Muscular weakness, Muscular weakness
Clinical narrative: Initial report received on 22/Sep/2006 from the agency. A 30-year-old male patient with no current illnesses had received a first intra-muscular dose of Menatra, lot number U2068AA, in the left arm on 31/Jul/2006. Nine days post-immunization, the patient developed tingling in his feet and face, as well as low back pain. The patient presented to the hospital and was sent home. His symptoms continued and he began to complain of weakness in his lower extremities. The follow day, the patient presented to the emergency room and was admitted. CSF showed RBC's 1, WBC's 0, Protein 92, Glucose 73, and Oligoclonal bands were negative. A CT without contrast was normal, ESR was normal, and an MRI of the L5 spine showed mild degenerative disc changes. A Drug/ETOH screen was negative. An EMG was complete and was consistent with demyelinating process. The patient's vital capacity was 1.4-1.5 liters, and a stool for campylobacter jejuni was still pending at the time of this report. The patient subsequently developed dysphagia to solid foods, but has not had any respiratory compromise. At the time of this report to agency, the patient was still hospitalized. As per the agency this case has not been confirmed by CISA as being Guillain Barre Syndrome following Menactra vaccinations. Follow-up information received on 27/Sep/2006 from the agency. Per the reported information, "this case is almost certainly Guillain Barre Syndrome. There is electrophysiologic and CSF confirmation. The only Guillain Barre criterion that there was not information on was myotactic reflexes'. The patient was hospitalized from 11/Aug/2006 to 28/Aug/2006 and then discharged to a rehabilitation unit.  Follow-Up Info: Patient went to Rehab Facility and made complete recovery in 4 weeks,
Age: 30.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Paraesthesia, Red blood cell sedimentation rate normal, Red blood cells CSF positive, Rehabilitation therapy
Clinical narrative: Initial report received on 22/Sep/2006 from the agency. A 30-year-old male patient with no current illnesses had received a first intra-muscular dose of Menatra, lot number U2068AA, in the left arm on 31/Jul/2006. Nine days post-immunization, the patient developed tingling in his feet and face, as well as low back pain. The patient presented to the hospital and was sent home. His symptoms continued and he began to complain of weakness in his lower extremities. The follow day, the patient presented to the emergency room and was admitted. CSF showed RBC's 1, WBC's 0, Protein 92, Glucose 73, and Oligoclonal bands were negative. A CT without contrast was normal, ESR was normal, and an MRI of the L5 spine showed mild degenerative disc changes. A Drug/ETOH screen was negative. An EMG was complete and was consistent with demyelinating process. The patient's vital capacity was 1.4-1.5 liters, and a stool for campylobacter jejuni was still pending at the time of this report. The patient subsequently developed dysphagia to solid foods, but has not had any respiratory compromise. At the time of this report to agency, the patient was still hospitalized. As per the agency this case has not been confirmed by CISA as being Guillain Barre Syndrome following Menactra vaccinations. Follow-up information received on 27/Sep/2006 from the agency. Per the reported information, "this case is almost certainly Guillain Barre Syndrome. There is electrophysiologic and CSF confirmation. The only Guillain Barre criterion that there was not information on was myotactic reflexes'. The patient was hospitalized from 11/Aug/2006 to 28/Aug/2006 and then discharged to a rehabilitation unit.  Follow-Up Info: Patient went to Rehab Facility and made complete recovery in 4 weeks,
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia, Proteinuria, Red blood cell sedimentation rate increased
Clinical narrative: Initial report received on 22/Sep/2006 from the Centers for Disease Control and Prevention (CDC). A 16 year old female patient had received an intramuscular, first dose injection of Menactra, lot number reported as 42017AA; and an intramuscular, first dose injection of Human Papillomavirus Recombinant Vaccine, lot number 0697F; on 31/Jul/2006. On or around 13/Aug/2006, the patient experienced numbness and tingling in her feet and hands. The symptoms persisted and had slightly worsened at the time of her examination by a physician on 21/Aug/2006. At that time, "neurological examination was normal." She had and elevated sedimentation rate (39), mild proteinuria, and "otherwise normal labs." Other laboratory tests performed, (specific results not provided), included a blood count, blood chemistries, pregnancy test and drug screen. MRI was performed of the brain, cervical, thoracic and lumbosacral spine. MRI of the lumbosacral spine showed a (possibly old, chronic) subarachnoid cyst. The patient was referred to and examined by a neurologist on 25/Aug/2006. During that exam, she was found to have weakened severely. She was admitted to a pediatric intensive care unit for suspected Guillain Barre syndrome which was confirmed by lumbar puncture. Lumbar puncture results were not provided. She was treated with IVIG with rapid improvement; and after five days of hospitalization, was discharged to home. Per the reported, she is slowly improving and had residual weakness. Recovery status was documented as unknown. As per the CDC this case was confirmed by CISA (Clinical Immunization Safety Assessment network) as being Guillain Barre syndrome following Menactra vaccination. Follow-up information received 27/Sep/2006 from the Centers for Disease Control and Prevention. Per the reported, the patient was hospitalized on 25/Aug/2006. The date of discharge was not reported. The patient's Guillain Barre Syndrome was confirmed by lumbar puncture testing.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Asthenia, Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia
Clinical narrative: Initial report received on 22/Sep/2006 from the Centers for Disease Control and Prevention (CDC). A 16 year old female patient had received an intramuscular, first dose injection of Menactra, lot number reported as 42017AA; and an intramuscular, first dose injection of Human Papillomavirus Recombinant Vaccine, lot number 0697F; on 31/Jul/2006. On or around 13/Aug/2006, the patient experienced numbness and tingling in her feet and hands. The symptoms persisted and had slightly worsened at the time of her examination by a physician on 21/Aug/2006. At that time, "neurological examination was normal." She had and elevated sedimentation rate (39), mild proteinuria, and "otherwise normal labs." Other laboratory tests performed, (specific results not provided), included a blood count, blood chemistries, pregnancy test and drug screen. MRI was performed of the brain, cervical, thoracic and lumbosacral spine. MRI of the lumbosacral spine showed a (possibly old, chronic) subarachnoid cyst. The patient was referred to and examined by a neurologist on 25/Aug/2006. During that exam, she was found to have weakened severely. She was admitted to a pediatric intensive care unit for suspected Guillain Barre syndrome which was confirmed by lumbar puncture. Lumbar puncture results were not provided. She was treated with IVIG with rapid improvement; and after five days of hospitalization, was discharged to home. Per the reported, she is slowly improving and had residual weakness. Recovery status was documented as unknown. As per the CDC this case was confirmed by CISA (Clinical Immunization Safety Assessment network) as being Guillain Barre syndrome following Menactra vaccination. Follow-up information received 27/Sep/2006 from the Centers for Disease Control and Prevention. Per the reported, the patient was hospitalized on 25/Aug/2006. The date of discharge was not reported. The patient's Guillain Barre Syndrome was confirmed by lumbar puncture testing.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Asthenia, Dehydration, Difficulty in walking, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Initial report received on 22/Sep/2006 from the Centers for Disease Control and Prevention. An "approximately" 16 year old female patient, with a history of attention deficit disorder, had received an intramuscular, first dose injection of Menactra, lot number U2069AA; and an intramuscular, first dose injection of Gardasil, lot number 06373F; on 07/Jul/2006. She had no illness at the time of vaccination. Concomitant medications included Adderall 50mg. Thirteen days post-vaccination, the patient experienced weakness "times several months." Although the report is difficult to read, it appears the reporter had written, "this was not objectively noticed then, but mostly after the vaccine." The event required hospitalization for one day. The patient was examined by a neurologist and treated with IVIG. The event was reported as Guillain Barre syndrome. The patient recovered from the event. As per the CDC this case has not yet been confirmed by CISA (Clinical Immunization Safety Assessment network) as being Guillain Barre syndrome following Menactra vaccination. The onset of symptoms may have been prior to vaccination. Follow up information, received on 27/Sep/2006 from the Centers for Disease Control and Prevention. Per the report, "there is doubt regarding the date of onset. The symptoms may have started in June of 2006 prior to vaccination. The neurologist's history of weakness goes back to late June before immunization. The primary care physician's report on the VAERS form was based on a physician assistant's screening history prior to vaccine administration that was not specific for neurologic symptoms." Per the CDC comments regarding GBS confirmation status, "Unless we get other information from the patient/family to the contrary, the neurologist's consult should stand, and this would not be a post-vaccine Guillain Barre case."
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Laboratory test abnormal, Paraesthesia, Psychomotor hyperactivity
Clinical narrative: Initial report received on 22/Sep/2006 from the Centers for Disease Control and Prevention. An "approximately" 16 year old female patient, with a history of attention deficit disorder, had received an intramuscular, first dose injection of Menactra, lot number U2069AA; and an intramuscular, first dose injection of Gardasil, lot number 06373F; on 07/Jul/2006. She had no illness at the time of vaccination. Concomitant medications included Adderall 50mg. Thirteen days post-vaccination, the patient experienced weakness "times several months." Although the report is difficult to read, it appears the reporter had written, "this was not objectively noticed then, but mostly after the vaccine." The event required hospitalization for one day. The patient was examined by a neurologist and treated with IVIG. The event was reported as Guillain Barre syndrome. The patient recovered from the event. As per the CDC this case has not yet been confirmed by CISA (Clinical Immunization Safety Assessment network) as being Guillain Barre syndrome following Menactra vaccination. The onset of symptoms may have been prior to vaccination. Follow up information, received on 27/Sep/2006 from the Centers for Disease Control and Prevention. Per the report, "there is doubt regarding the date of onset. The symptoms may have started in June of 2006 prior to vaccination. The neurologist's history of weakness goes back to late June before immunization. The primary care physician's report on the VAERS form was based on a physician assistant's screening history prior to vaccine administration that was not specific for neurologic symptoms." Per the CDC comments regarding GBS confirmation status, "Unless we get other information from the patient/family to the contrary, the neurologist's consult should stand, and this would not be a post-vaccine Guillain Barre case."
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Asthenia, Guillain-Barre syndrome
Clinical narrative: Initial report received on 22/Sep/2006 from the Centers for Disease Control and Prevention. An "approximately" 16 year old female patient, with a history of attention deficit disorder, had received an intramuscular, first dose injection of Menactra, lot number U2069AA; and an intramuscular, first dose injection of Gardasil, lot number 06373F; on 07/Jul/2006. She had no illness at the time of vaccination. Concomitant medications included Adderall 50mg. Thirteen days post-vaccination, the patient experienced weakness "times several months." Although the report is difficult to read, it appears the reporter had written, "this was not objectively noticed then, but mostly after the vaccine." The event required hospitalization for one day. The patient was examined by a neurologist and treated with IVIG. The event was reported as Guillain Barre syndrome. The patient recovered from the event. As per the CDC this case has not yet been confirmed by CISA (Clinical Immunization Safety Assessment network) as being Guillain Barre syndrome following Menactra vaccination. The onset of symptoms may have been prior to vaccination. Follow up information, received on 27/Sep/2006 from the Centers for Disease Control and Prevention. Per the report, "there is doubt regarding the date of onset. The symptoms may have started in June of 2006 prior to vaccination. The neurologist's history of weakness goes back to late June before immunization. The primary care physician's report on the VAERS form was based on a physician assistant's screening history prior to vaccine administration that was not specific for neurologic symptoms." Per the CDC comments regarding GBS confirmation status, "Unless we get other information from the patient/family to the contrary, the neurologist's consult should stand, and this would not be a post-vaccine Guillain Barre case."
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Asthenia, Hypoaesthesia, Neuropathy peripheral, Paralysis
Clinical narrative: Initial report received on 04/Oct/2006 from the agency. The agency received the original report from a health care professional. A 19-year-old male patient, with no significant medical history, had received a first, intra-muscular, left deltoid dose of Menactra, lot number U1493AC, on 28/Jun/2005. The patient woke up at 08:00 am on 14/Feb/2006 with peripheral neuropathy, 231 days pots-vaccination. Two days later, the neuropathy had progressed and continued to progress to include partial left VIth nerve palsy, facial diplegia, and lower leg weakness and numbness. The following day, the patient was treated with a 12 day regimen of IV steroids from 18/Feb/2006 to 01/Mar/2006. He was subsequently treated with a four day regimen of IVIG therapy from 06/Mar/2006 to 09/Mar/2006. Per the reporter, the patient had "antibodies to GaINAc recovered". The patient was hospitalized for 15 days. Reportedly, the patient gradually recovered over two to three months. (OMIC)
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Facial palsy, Hypoaesthesia, Muscular weakness, Neuropathy peripheral, Paralysis
Clinical narrative: Initial report received on 04/Oct/2006 from the agency. The agency received the original report from a health care professional. A 19-year-old male patient, with no significant medical history, had received a first, intra-muscular, left deltoid dose of Menactra, lot number U1493AC, on 28/Jun/2005. The patient woke up at 08:00 am on 14/Feb/2006 with peripheral neuropathy, 231 days pots-vaccination. Two days later, the neuropathy had progressed and continued to progress to include partial left VIth nerve palsy, facial diplegia, and lower leg weakness and numbness. The following day, the patient was treated with a 12 day regimen of IV steroids from 18/Feb/2006 to 01/Mar/2006. He was subsequently treated with a four day regimen of IVIG therapy from 06/Mar/2006 to 09/Mar/2006. Per the reporter, the patient had "antibodies to GaINAc recovered". The patient was hospitalized for 15 days. Reportedly, the patient gradually recovered over two to three months. (OMIC)
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Dyspnoea, Muscle spasms
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 05 December 2006 from a health care professional. A 47 year old female patient, with a history of food induced anaphylactic reactions, and who was taking Prednisone, Albuterol and Zyrtec, had received a dose of Fluzone on 27 November 2006 at 11:00 pm. The lot number, route and site of administration were not reported. Twenty minutes post immunization, at 11:20 pm, the patient experienced chest tightness, shortness of breath, and spasmodic coughing. The patient was administered Adrenalin, and transported to the emergency room via rescue EMS where she was treated and released. Treatments received, and diagnostic tests performed were not reported. At the time of this report, the patient had not recovered. A corrective version (1), (with the same latest received date as the previous version), was generated in order to amend the category in this case as serious, category II, for reporting purposes.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Haematuria, Henoch-Schonlein purpura, Rash
Clinical narrative: Initial report received on 07 December 2006 from a health care professional. A five year old male patient, with a history of asthma, and who was taking Albuterol and Claritin, had received a first dose, right deltoid injection of Fluzone, lot number U2239AA, on 20 September 2006. The route of administration was not reported. The patient was seen in the physicians office 29 days post immunization for his second Fluzone injection. The second dose was not given as the patient was noted to have a skin rash on his legs, arms, abdomen and had minor hematuria. The patient was diagnosed with Henoch Schonlein purpura and was hospitalized four days later, on 23 October 2006. The patient was treated with oral and IV antibiotics. He was hospitalized for two days. At the time of this report, the patient had recovered.
Age: 44.0
Sex: U
Vaccine: FLU3
Symptoms: Pain, Radiculitis brachial
Clinical narrative: A report was received from a healthcare professional on 05 Dec 2006, concerning a 44 year old vaccinee (sex unspecified). No details concerning the vaccinee's past medical history or concomitant medications were provided. The vaccinee was administered Fluvirin 0.5ml by intramuscular injection on an unspecified date, the vaccinee then developed arm pain, and was subsequently diagnosed as having brachial neuritis. The reporter considered the event to be serious, hospitalisation and disability/incapacity. The events are ongoing. Further information is requested.
Age: 32.0
Sex: U
Vaccine: FLU3
Symptoms: Pain, Radiculitis brachial
Clinical narrative: A report was received from healthcare professional on 04 Dec 2006, concerning an unidentifiable vaccinee. The reporter stated that 6 or 7 employees experienced swollen tender arms, with difficulty elevating the arm for weeks after the vaccination. Further information will be requested. Follow up received from a healthcare professional on 05/Dec/2006, identified the vaccinee as a 32 year old. No details concerning the vaccinee's past medical history or concomitant medications were provided. The vaccinee was administered Fluvirin 0.5ml by intramuscular injection on an unspecified date, developed an acute painful arm for 3-4 weeks and was subsequently diagnosed as having brachial neuritis. The reporter considered the event to be serious, hospitalisation and disability/incapacity. The events are ongoing. Further information is requested.
Age: 33.0
Sex: U
Vaccine: FLU3
Symptoms: Radiculitis brachial
Clinical narrative: A report was received from a healthcare professional on 04/Dec/2006, concerning a vaccinee (no identifiers provided). No details concerning the vaccinee past medical history or concomitant medications were provided. The vaccinee was administered Fluvirin on an unspecified date, and was subsequently diagnosed as having brachial neuritis. Follow up information was received from a health care professional on 05/Dec/2006. the vaccinee has been identified as a 33 year old, who received 0.5ml of Fluvirin by intramuscular injection. The vaccinee has still not recovered. The reporter considered the event to be serious, hospitalisation and disability/incapacity. Further information will be requested.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Atelectasis, Back pain, Inflammation, Paraesthesia
Clinical narrative: A report was  received from a health care professional on 05/Dec/2006 concerning a 64 year old female vaccinee. No details of the vaccinee's past medical history or concomitant medications were provided. The vaccinee received Fluvirin by intramuscular injection on 12/OCT/2006. On 05/Nov/2006 she began complaining of low back pain, which spread up to her mid back over 1.5 weeks. The pain was severe, and on 11/Nov/2006, the vaccinee developed tingling in her hands when reaching out. the vaccinee was seen by a neurosurgeon, but no cause was found for the pain. the vaccinee had no pain control with Lorcet, Lortab , Demerol and Pnenergan. She was then admitted to hospital and commenced on a Morphine pump which provided some pain relief. By this time the vaccinee had had 10 MRI and CT scans with no results. A CT of her chest revealed ataletasis secondary to not breathing deeply due to the pain. On 27/Nov/2006, the neurologist performed nerve conduction studies, which revealed inflammation of the nerve roots, the vaccinee's physician considered this to be caused by either a virus or immunisation. Further information is requested.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Dyspnoea, Musculoskeletal stiffness, Oedema peripheral, Wheezing
Clinical narrative: A consumer report was received on 04/Dec/2006. concerning a 42 year old female vaccinee. No details concerning the vaccinee's past medical history or concomitant medications were provided, but the vaccinee has no known egg allergy. On 16/Oct/2006 the vaccinee received Fluvirin by intramuscular injection. 17 minutes later she began wheezing, and she was given Epinephrine, admitted to hospital and discharged later that day. The vaccine continues to experience muscle stiffness, joint pain, swollen hands (especially the right index finger) and shortness of breath (onset date not specified). Further information will be sought.
Age: 40.0
Sex: U
Vaccine: FLU3
Symptoms: Radiculitis brachial
Clinical narrative: A report was received from a healthcare professional on 05/Dec/2006, concerning a 40 year old vaccine (sex unspecified). No details concerning the vaccinee's past medical history or concomitant medications were provided. The vaccinee was administered Fluvirin 0.5ml by intramuscular injection on an unspecified date at the end of September, and was subsequently diagnosed as having brachial neuritis. The reporter considered the event to be serious, hospitalisation and disability/incapacity. The events are ongoing. Further information is requested.