chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a 60 year old male patient. Concurrent condition and medical history were not reported. On 13-AUG-2015 (reported as "yesterday"), the patient was administered with expired ZOSTAVAX lot # K000325, expiration date 27-FEB-2015, 0.65 ml) subcutaneously in left arm. The patient's concomitant medication was not reported. No adverse effect reported. There was no product quality complaints (PQC) involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: Information has been received from a physician via company representative to three female patients of unknown age. On unknown dates the patients were vaccinated with doses of ZOSTAVAX (one time injection, dose, strength, lot# and expiration date unknown) subcutaneously. On unknown dates, the three patients experienced a shingles rash around there eyes after receiving the ZOSTAVAX. The patients sought medical attention by calling the office and were referred to ophthalmologists. Unspecified treatments were given by the ophthalmologists. The outcome of the event was unknown. Causality was not provided. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Paraesthesia
Clinical narrative: Information has been received from a pharmacist referring to a 30 year old female patient with asthma and chronic bronchitis. The patient has allergies to penicillin, tramadol and cinnarizine. On 17-AUG-2015 the patient was vaccinated with her first dose of PNEUMOVAX 23 intramuscularly (dose and lot# were not reported). Concomitant therapy included ZANAFLEX. On 18-AUG-2015 the patient developed soreness and swelling at injection site. On 19-AUG-2015, the patient was experiencing tingling in the arm that the PNEUMOVAX 23 was administered as well as redness, soreness, and swelling at injection site. The patient did not seek medical attention. No lab diagnostics studies were performed. Ibuprofen was given for the adverse events. The outcome of all the events was reported as not recovered. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. No relevant medical or historical conditions were reported. On 12-AUG-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), 0.5 ml, subcutaneously (lot# L010143, expiration date 24-SEP-2016), which was exposed to -10 Degree Celsius for 14 hours. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered medical assistant referring to an unspecified number of patients of unknown age and gender. On an unknown date in 2015, the patients were vaccinated with improperly stored RECOMBIVAX HB (dose, strength and route were not reported, lot# reported as K022265). The temperature was possible out of range by 2 degrees to 3 degrees for short periods of time over a couple of days in April 2015. No adverse events were reported. This case is one of several cases received from the same source. Additional information has been requested. This case was initially received on 28-MAY-2015 and reported in 1506USA000574, 1506USA000574 has been deleted upon the follow up information received on 01-JUL-2015, in which the medical assistant stated no incorrect product storage happened. Now, case was re-created due to new follow up information was received from the medical assistant on 13-AUG-2015 and incorrect product storage was confirmed.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered medical assistant referring to an unspecified number of patients of unknown age and gender. On an unknown date in 2015, the patients were vaccinated with improperly stored VAQTA (dose, strength and route were not reported, lot# K008333). The temperature was possible out of range by 2 degrees to 3 degrees for short periods of time over a couple of days in April 2015. No adverse events were reported. This case is one of several cases received from the same source. Additional information has been requested. This case was initially received on 28-MAY-2015 and reported in 1506USA000576, 1506USA000576 has been deleted upon the follow up information received on 01-JUL-2015, in which the medical assistant stated no incorrect product storage happened. Now, case was re-created due to new follow up information was received from the medical assistant on 13-AUG-2015 and incorrect product storage was confirmed.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Mom called at 10:30 am c/o child had stomach cramps first 2 days with diarrhea since Saturday. Cramps stopped post BRAT diet Saturday. Advised electrolyte replacement and assess if continues. CAC on stool and urine and # of stools per day. See PMD.
Age: 43.0
Sex: F
Vaccine: FLUN3
Symptoms: Abasia, Activities of daily living impaired, Alanine aminotransferase increased, Amylase decreased, Aspartate aminotransferase normal
Clinical narrative: A report has been received from Regulatory Authority from VAERS, a 43 year old, female patient. The patient's medical history included right elbow surgery, left shoulder surgery, vaginal hysterectomy, appendectomy, cholecystomy and tonsillectomy. The patient's concurrent diseases included hyperlipidemia and esophageal acid reflux. This report to VAERS provided the following narrative: Post marketed evaluation of the safety of in healthy children and healthy Adults 5 through 49 years of age. This is a 43 year old female who received FLUMIST on 14-Nov-2005 and was diagnosed with Guillain Barre syndrome which started on 26-Jan-2006. On 26-Jan-2006 at approximately 2am, the patient woke up and walked to the bathroom. She reported having difficulty using her right hand and almost fell down while she was walking to the toilet. She was seen at a hospital and was found to have a low potassium level of 2.8 which was repleted to 3.2. She also complained of a headache and neck stiffness, head CT was negative and a lumbar puncture was negative aside from and elevated CSF protein of 67. She was discharge home. A week prior to this event, she complained of flu like illness. At home, she was unable to walk and became almost quadriplegic. She was then brought to the emergency room. In the emergency room, neurology was consulted and an EMG was done with findings that were was strongly suggestive of Guillain Barre syndrome. She was then given DILAUDID 1mg IV and intravenous immunoglobulin IVIG was started at 400mg kg day to complete a total of 5 days. Other treatment include plasmapheresis. During the course of her hospitalization, she was also diagnosed with depression and was placed on PROZAC. She was discharged after 31 days to a skilled nursing facility. In the SNF, DILAUDID was continued for pain management together with FENTANYL patch. as of 18-Apr-2006 the rehabilitation notes indicated that the patient remains dependent on all activities of daily living although she continues to show increased strength for trunk and hip control. The SNF consult notes also indicated that she does not have sufficient motor neuron recovered to give significant gains in functional mobility. Physical therapy in ongoing. Medications in the SNF included. Subcutaneous Heparin, TYLENOL, NEVACOR, PRILOSEC, Quinine sulfate, ELAVIL, FENTANYL patch, DILAUDID, ATIVAN, COLACE, SENNA, DULCOLAX, MILK OF MAGNESIA, Oil enema, NASAREL and Artificial tears. The patient has not yet recovered. The reporter has assessed this event as not related to FLUMIST. The company physician agreed with this causality. Assessment of the Serious criteria for the report was as follows: Disability, Life threatening and Hospitalised. Laboratory values are available.
Age: 43.0
Sex: F
Vaccine: FLUN3
Symptoms: Bilirubin conjugated normal, Blood alkaline phosphatase decreased, Blood bicarbonate increased, Blood bilirubin normal, Blood calcium normal
Clinical narrative: A report has been received from Regulatory Authority from VAERS, a 43 year old, female patient. The patient's medical history included right elbow surgery, left shoulder surgery, vaginal hysterectomy, appendectomy, cholecystomy and tonsillectomy. The patient's concurrent diseases included hyperlipidemia and esophageal acid reflux. This report to VAERS provided the following narrative: Post marketed evaluation of the safety of in healthy children and healthy Adults 5 through 49 years of age. This is a 43 year old female who received FLUMIST on 14-Nov-2005 and was diagnosed with Guillain Barre syndrome which started on 26-Jan-2006. On 26-Jan-2006 at approximately 2am, the patient woke up and walked to the bathroom. She reported having difficulty using her right hand and almost fell down while she was walking to the toilet. She was seen at a hospital and was found to have a low potassium level of 2.8 which was repleted to 3.2. She also complained of a headache and neck stiffness, head CT was negative and a lumbar puncture was negative aside from and elevated CSF protein of 67. She was discharge home. A week prior to this event, she complained of flu like illness. At home, she was unable to walk and became almost quadriplegic. She was then brought to the emergency room. In the emergency room, neurology was consulted and an EMG was done with findings that were was strongly suggestive of Guillain Barre syndrome. She was then given DILAUDID 1mg IV and intravenous immunoglobulin IVIG was started at 400mg kg day to complete a total of 5 days. Other treatment include plasmapheresis. During the course of her hospitalization, she was also diagnosed with depression and was placed on PROZAC. She was discharged after 31 days to a skilled nursing facility. In the SNF, DILAUDID was continued for pain management together with FENTANYL patch. as of 18-Apr-2006 the rehabilitation notes indicated that the patient remains dependent on all activities of daily living although she continues to show increased strength for trunk and hip control. The SNF consult notes also indicated that she does not have sufficient motor neuron recovered to give significant gains in functional mobility. Physical therapy in ongoing. Medications in the SNF included. Subcutaneous Heparin, TYLENOL, NEVACOR, PRILOSEC, Quinine sulfate, ELAVIL, FENTANYL patch, DILAUDID, ATIVAN, COLACE, SENNA, DULCOLAX, MILK OF MAGNESIA, Oil enema, NASAREL and Artificial tears. The patient has not yet recovered. The reporter has assessed this event as not related to FLUMIST. The company physician agreed with this causality. Assessment of the Serious criteria for the report was as follows: Disability, Life threatening and Hospitalised. Laboratory values are available.
Age: 43.0
Sex: F
Vaccine: FLUN3
Symptoms: Blood chloride decreased, Blood creatine phosphokinase MB increased, Blood creatinine normal, Blood glucose increased, Blood potassium decreased
Clinical narrative: A report has been received from Regulatory Authority from VAERS, a 43 year old, female patient. The patient's medical history included right elbow surgery, left shoulder surgery, vaginal hysterectomy, appendectomy, cholecystomy and tonsillectomy. The patient's concurrent diseases included hyperlipidemia and esophageal acid reflux. This report to VAERS provided the following narrative: Post marketed evaluation of the safety of in healthy children and healthy Adults 5 through 49 years of age. This is a 43 year old female who received FLUMIST on 14-Nov-2005 and was diagnosed with Guillain Barre syndrome which started on 26-Jan-2006. On 26-Jan-2006 at approximately 2am, the patient woke up and walked to the bathroom. She reported having difficulty using her right hand and almost fell down while she was walking to the toilet. She was seen at a hospital and was found to have a low potassium level of 2.8 which was repleted to 3.2. She also complained of a headache and neck stiffness, head CT was negative and a lumbar puncture was negative aside from and elevated CSF protein of 67. She was discharge home. A week prior to this event, she complained of flu like illness. At home, she was unable to walk and became almost quadriplegic. She was then brought to the emergency room. In the emergency room, neurology was consulted and an EMG was done with findings that were was strongly suggestive of Guillain Barre syndrome. She was then given DILAUDID 1mg IV and intravenous immunoglobulin IVIG was started at 400mg kg day to complete a total of 5 days. Other treatment include plasmapheresis. During the course of her hospitalization, she was also diagnosed with depression and was placed on PROZAC. She was discharged after 31 days to a skilled nursing facility. In the SNF, DILAUDID was continued for pain management together with FENTANYL patch. as of 18-Apr-2006 the rehabilitation notes indicated that the patient remains dependent on all activities of daily living although she continues to show increased strength for trunk and hip control. The SNF consult notes also indicated that she does not have sufficient motor neuron recovered to give significant gains in functional mobility. Physical therapy in ongoing. Medications in the SNF included. Subcutaneous Heparin, TYLENOL, NEVACOR, PRILOSEC, Quinine sulfate, ELAVIL, FENTANYL patch, DILAUDID, ATIVAN, COLACE, SENNA, DULCOLAX, MILK OF MAGNESIA, Oil enema, NASAREL and Artificial tears. The patient has not yet recovered. The reporter has assessed this event as not related to FLUMIST. The company physician agreed with this causality. Assessment of the Serious criteria for the report was as follows: Disability, Life threatening and Hospitalised. Laboratory values are available.
Age: 43.0
Sex: F
Vaccine: FLUN3
Symptoms: Blood urea normal, CSF glucose normal, CSF protein, CSF red blood cell count positive, CSF test abnormal
Clinical narrative: A report has been received from Regulatory Authority from VAERS, a 43 year old, female patient. The patient's medical history included right elbow surgery, left shoulder surgery, vaginal hysterectomy, appendectomy, cholecystomy and tonsillectomy. The patient's concurrent diseases included hyperlipidemia and esophageal acid reflux. This report to VAERS provided the following narrative: Post marketed evaluation of the safety of in healthy children and healthy Adults 5 through 49 years of age. This is a 43 year old female who received FLUMIST on 14-Nov-2005 and was diagnosed with Guillain Barre syndrome which started on 26-Jan-2006. On 26-Jan-2006 at approximately 2am, the patient woke up and walked to the bathroom. She reported having difficulty using her right hand and almost fell down while she was walking to the toilet. She was seen at a hospital and was found to have a low potassium level of 2.8 which was repleted to 3.2. She also complained of a headache and neck stiffness, head CT was negative and a lumbar puncture was negative aside from and elevated CSF protein of 67. She was discharge home. A week prior to this event, she complained of flu like illness. At home, she was unable to walk and became almost quadriplegic. She was then brought to the emergency room. In the emergency room, neurology was consulted and an EMG was done with findings that were was strongly suggestive of Guillain Barre syndrome. She was then given DILAUDID 1mg IV and intravenous immunoglobulin IVIG was started at 400mg kg day to complete a total of 5 days. Other treatment include plasmapheresis. During the course of her hospitalization, she was also diagnosed with depression and was placed on PROZAC. She was discharged after 31 days to a skilled nursing facility. In the SNF, DILAUDID was continued for pain management together with FENTANYL patch. as of 18-Apr-2006 the rehabilitation notes indicated that the patient remains dependent on all activities of daily living although she continues to show increased strength for trunk and hip control. The SNF consult notes also indicated that she does not have sufficient motor neuron recovered to give significant gains in functional mobility. Physical therapy in ongoing. Medications in the SNF included. Subcutaneous Heparin, TYLENOL, NEVACOR, PRILOSEC, Quinine sulfate, ELAVIL, FENTANYL patch, DILAUDID, ATIVAN, COLACE, SENNA, DULCOLAX, MILK OF MAGNESIA, Oil enema, NASAREL and Artificial tears. The patient has not yet recovered. The reporter has assessed this event as not related to FLUMIST. The company physician agreed with this causality. Assessment of the Serious criteria for the report was as follows: Disability, Life threatening and Hospitalised. Laboratory values are available.
Age: 43.0
Sex: F
Vaccine: FLUN3
Symptoms: CSF white blood cell count negative, Computerised tomogram head normal, Depression, Electrocardiogram, Electromyogram
Clinical narrative: A report has been received from Regulatory Authority from VAERS, a 43 year old, female patient. The patient's medical history included right elbow surgery, left shoulder surgery, vaginal hysterectomy, appendectomy, cholecystomy and tonsillectomy. The patient's concurrent diseases included hyperlipidemia and esophageal acid reflux. This report to VAERS provided the following narrative: Post marketed evaluation of the safety of in healthy children and healthy Adults 5 through 49 years of age. This is a 43 year old female who received FLUMIST on 14-Nov-2005 and was diagnosed with Guillain Barre syndrome which started on 26-Jan-2006. On 26-Jan-2006 at approximately 2am, the patient woke up and walked to the bathroom. She reported having difficulty using her right hand and almost fell down while she was walking to the toilet. She was seen at a hospital and was found to have a low potassium level of 2.8 which was repleted to 3.2. She also complained of a headache and neck stiffness, head CT was negative and a lumbar puncture was negative aside from and elevated CSF protein of 67. She was discharge home. A week prior to this event, she complained of flu like illness. At home, she was unable to walk and became almost quadriplegic. She was then brought to the emergency room. In the emergency room, neurology was consulted and an EMG was done with findings that were was strongly suggestive of Guillain Barre syndrome. She was then given DILAUDID 1mg IV and intravenous immunoglobulin IVIG was started at 400mg kg day to complete a total of 5 days. Other treatment include plasmapheresis. During the course of her hospitalization, she was also diagnosed with depression and was placed on PROZAC. She was discharged after 31 days to a skilled nursing facility. In the SNF, DILAUDID was continued for pain management together with FENTANYL patch. as of 18-Apr-2006 the rehabilitation notes indicated that the patient remains dependent on all activities of daily living although she continues to show increased strength for trunk and hip control. The SNF consult notes also indicated that she does not have sufficient motor neuron recovered to give significant gains in functional mobility. Physical therapy in ongoing. Medications in the SNF included. Subcutaneous Heparin, TYLENOL, NEVACOR, PRILOSEC, Quinine sulfate, ELAVIL, FENTANYL patch, DILAUDID, ATIVAN, COLACE, SENNA, DULCOLAX, MILK OF MAGNESIA, Oil enema, NASAREL and Artificial tears. The patient has not yet recovered. The reporter has assessed this event as not related to FLUMIST. The company physician agreed with this causality. Assessment of the Serious criteria for the report was as follows: Disability, Life threatening and Hospitalised. Laboratory values are available.
Age: 43.0
Sex: F
Vaccine: FLUN3
Symptoms: Fall, Gait disturbance, Gram stain negative, Guillain-Barre syndrome, Haematocrit decreased
Clinical narrative: A report has been received from Regulatory Authority from VAERS, a 43 year old, female patient. The patient's medical history included right elbow surgery, left shoulder surgery, vaginal hysterectomy, appendectomy, cholecystomy and tonsillectomy. The patient's concurrent diseases included hyperlipidemia and esophageal acid reflux. This report to VAERS provided the following narrative: Post marketed evaluation of the safety of in healthy children and healthy Adults 5 through 49 years of age. This is a 43 year old female who received FLUMIST on 14-Nov-2005 and was diagnosed with Guillain Barre syndrome which started on 26-Jan-2006. On 26-Jan-2006 at approximately 2am, the patient woke up and walked to the bathroom. She reported having difficulty using her right hand and almost fell down while she was walking to the toilet. She was seen at a hospital and was found to have a low potassium level of 2.8 which was repleted to 3.2. She also complained of a headache and neck stiffness, head CT was negative and a lumbar puncture was negative aside from and elevated CSF protein of 67. She was discharge home. A week prior to this event, she complained of flu like illness. At home, she was unable to walk and became almost quadriplegic. She was then brought to the emergency room. In the emergency room, neurology was consulted and an EMG was done with findings that were was strongly suggestive of Guillain Barre syndrome. She was then given DILAUDID 1mg IV and intravenous immunoglobulin IVIG was started at 400mg kg day to complete a total of 5 days. Other treatment include plasmapheresis. During the course of her hospitalization, she was also diagnosed with depression and was placed on PROZAC. She was discharged after 31 days to a skilled nursing facility. In the SNF, DILAUDID was continued for pain management together with FENTANYL patch. as of 18-Apr-2006 the rehabilitation notes indicated that the patient remains dependent on all activities of daily living although she continues to show increased strength for trunk and hip control. The SNF consult notes also indicated that she does not have sufficient motor neuron recovered to give significant gains in functional mobility. Physical therapy in ongoing. Medications in the SNF included. Subcutaneous Heparin, TYLENOL, NEVACOR, PRILOSEC, Quinine sulfate, ELAVIL, FENTANYL patch, DILAUDID, ATIVAN, COLACE, SENNA, DULCOLAX, MILK OF MAGNESIA, Oil enema, NASAREL and Artificial tears. The patient has not yet recovered. The reporter has assessed this event as not related to FLUMIST. The company physician agreed with this causality. Assessment of the Serious criteria for the report was as follows: Disability, Life threatening and Hospitalised. Laboratory values are available.
Age: 43.0
Sex: F
Vaccine: FLUN3
Symptoms: Haematocrit increased, Headache, Immunoglobulin therapy, Influenza like illness, Laboratory test abnormal
Clinical narrative: A report has been received from Regulatory Authority from VAERS, a 43 year old, female patient. The patient's medical history included right elbow surgery, left shoulder surgery, vaginal hysterectomy, appendectomy, cholecystomy and tonsillectomy. The patient's concurrent diseases included hyperlipidemia and esophageal acid reflux. This report to VAERS provided the following narrative: Post marketed evaluation of the safety of in healthy children and healthy Adults 5 through 49 years of age. This is a 43 year old female who received FLUMIST on 14-Nov-2005 and was diagnosed with Guillain Barre syndrome which started on 26-Jan-2006. On 26-Jan-2006 at approximately 2am, the patient woke up and walked to the bathroom. She reported having difficulty using her right hand and almost fell down while she was walking to the toilet. She was seen at a hospital and was found to have a low potassium level of 2.8 which was repleted to 3.2. She also complained of a headache and neck stiffness, head CT was negative and a lumbar puncture was negative aside from and elevated CSF protein of 67. She was discharge home. A week prior to this event, she complained of flu like illness. At home, she was unable to walk and became almost quadriplegic. She was then brought to the emergency room. In the emergency room, neurology was consulted and an EMG was done with findings that were was strongly suggestive of Guillain Barre syndrome. She was then given DILAUDID 1mg IV and intravenous immunoglobulin IVIG was started at 400mg kg day to complete a total of 5 days. Other treatment include plasmapheresis. During the course of her hospitalization, she was also diagnosed with depression and was placed on PROZAC. She was discharged after 31 days to a skilled nursing facility. In the SNF, DILAUDID was continued for pain management together with FENTANYL patch. as of 18-Apr-2006 the rehabilitation notes indicated that the patient remains dependent on all activities of daily living although she continues to show increased strength for trunk and hip control. The SNF consult notes also indicated that she does not have sufficient motor neuron recovered to give significant gains in functional mobility. Physical therapy in ongoing. Medications in the SNF included. Subcutaneous Heparin, TYLENOL, NEVACOR, PRILOSEC, Quinine sulfate, ELAVIL, FENTANYL patch, DILAUDID, ATIVAN, COLACE, SENNA, DULCOLAX, MILK OF MAGNESIA, Oil enema, NASAREL and Artificial tears. The patient has not yet recovered. The reporter has assessed this event as not related to FLUMIST. The company physician agreed with this causality. Assessment of the Serious criteria for the report was as follows: Disability, Life threatening and Hospitalised. Laboratory values are available.
Age: 43.0
Sex: F
Vaccine: FLUN3
Symptoms: Lipase increased, Musculoskeletal disorder, Musculoskeletal stiffness, Nerve conduction studies, Neutropenia
Clinical narrative: A report has been received from Regulatory Authority from VAERS, a 43 year old, female patient. The patient's medical history included right elbow surgery, left shoulder surgery, vaginal hysterectomy, appendectomy, cholecystomy and tonsillectomy. The patient's concurrent diseases included hyperlipidemia and esophageal acid reflux. This report to VAERS provided the following narrative: Post marketed evaluation of the safety of in healthy children and healthy Adults 5 through 49 years of age. This is a 43 year old female who received FLUMIST on 14-Nov-2005 and was diagnosed with Guillain Barre syndrome which started on 26-Jan-2006. On 26-Jan-2006 at approximately 2am, the patient woke up and walked to the bathroom. She reported having difficulty using her right hand and almost fell down while she was walking to the toilet. She was seen at a hospital and was found to have a low potassium level of 2.8 which was repleted to 3.2. She also complained of a headache and neck stiffness, head CT was negative and a lumbar puncture was negative aside from and elevated CSF protein of 67. She was discharge home. A week prior to this event, she complained of flu like illness. At home, she was unable to walk and became almost quadriplegic. She was then brought to the emergency room. In the emergency room, neurology was consulted and an EMG was done with findings that were was strongly suggestive of Guillain Barre syndrome. She was then given DILAUDID 1mg IV and intravenous immunoglobulin IVIG was started at 400mg kg day to complete a total of 5 days. Other treatment include plasmapheresis. During the course of her hospitalization, she was also diagnosed with depression and was placed on PROZAC. She was discharged after 31 days to a skilled nursing facility. In the SNF, DILAUDID was continued for pain management together with FENTANYL patch. as of 18-Apr-2006 the rehabilitation notes indicated that the patient remains dependent on all activities of daily living although she continues to show increased strength for trunk and hip control. The SNF consult notes also indicated that she does not have sufficient motor neuron recovered to give significant gains in functional mobility. Physical therapy in ongoing. Medications in the SNF included. Subcutaneous Heparin, TYLENOL, NEVACOR, PRILOSEC, Quinine sulfate, ELAVIL, FENTANYL patch, DILAUDID, ATIVAN, COLACE, SENNA, DULCOLAX, MILK OF MAGNESIA, Oil enema, NASAREL and Artificial tears. The patient has not yet recovered. The reporter has assessed this event as not related to FLUMIST. The company physician agreed with this causality. Assessment of the Serious criteria for the report was as follows: Disability, Life threatening and Hospitalised. Laboratory values are available.
Age: 43.0
Sex: F
Vaccine: FLUN3
Symptoms: Neutrophil count decreased, Plasmapheresis, Platelet disorder, Red blood cell abnormality, White blood cell disorder
Clinical narrative: A report has been received from Regulatory Authority from VAERS, a 43 year old, female patient. The patient's medical history included right elbow surgery, left shoulder surgery, vaginal hysterectomy, appendectomy, cholecystomy and tonsillectomy. The patient's concurrent diseases included hyperlipidemia and esophageal acid reflux. This report to VAERS provided the following narrative: Post marketed evaluation of the safety of in healthy children and healthy Adults 5 through 49 years of age. This is a 43 year old female who received FLUMIST on 14-Nov-2005 and was diagnosed with Guillain Barre syndrome which started on 26-Jan-2006. On 26-Jan-2006 at approximately 2am, the patient woke up and walked to the bathroom. She reported having difficulty using her right hand and almost fell down while she was walking to the toilet. She was seen at a hospital and was found to have a low potassium level of 2.8 which was repleted to 3.2. She also complained of a headache and neck stiffness, head CT was negative and a lumbar puncture was negative aside from and elevated CSF protein of 67. She was discharge home. A week prior to this event, she complained of flu like illness. At home, she was unable to walk and became almost quadriplegic. She was then brought to the emergency room. In the emergency room, neurology was consulted and an EMG was done with findings that were was strongly suggestive of Guillain Barre syndrome. She was then given DILAUDID 1mg IV and intravenous immunoglobulin IVIG was started at 400mg kg day to complete a total of 5 days. Other treatment include plasmapheresis. During the course of her hospitalization, she was also diagnosed with depression and was placed on PROZAC. She was discharged after 31 days to a skilled nursing facility. In the SNF, DILAUDID was continued for pain management together with FENTANYL patch. as of 18-Apr-2006 the rehabilitation notes indicated that the patient remains dependent on all activities of daily living although she continues to show increased strength for trunk and hip control. The SNF consult notes also indicated that she does not have sufficient motor neuron recovered to give significant gains in functional mobility. Physical therapy in ongoing. Medications in the SNF included. Subcutaneous Heparin, TYLENOL, NEVACOR, PRILOSEC, Quinine sulfate, ELAVIL, FENTANYL patch, DILAUDID, ATIVAN, COLACE, SENNA, DULCOLAX, MILK OF MAGNESIA, Oil enema, NASAREL and Artificial tears. The patient has not yet recovered. The reporter has assessed this event as not related to FLUMIST. The company physician agreed with this causality. Assessment of the Serious criteria for the report was as follows: Disability, Life threatening and Hospitalised. Laboratory values are available.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Aphonia, Areflexia, Asthenia, Back pain, Barium swallow normal
Clinical narrative: A report has been received from a health professional via VAERS (VAERS No. 337347) concerning a 6 year old female patient. No information was provided regarding relevant history, concurrent diseases and concomitant medications. The patient received FLUMIST (intranasal) on 16-Oct-2008. The patient received the flu shot in mid-October and displayed a fever during weekend in November with no other symptoms. She fell off the monkey bars at school on 13-Nov-2008 and started to complain of tingling and loss of control of limbs on right side on 14-Nov-2008. She started losing her voice 30-Nov-2008. She complained of her head tingling on 09-Dec-2008 and subsequently went to doctor on 10-Dec-2008 and had MRI, nerve conduction tests, etc and was finally diagnosed with GBS (Guillain-Barre syndrome) on about 12-Dec-2008. Medical records stated Guillain-Barre syndrome. Presented with complaints of tingling all four extremities for about 4 weeks, back pain and leg pain. Day prior to hospitalization fell from monkey bar approximately 6 feet high. Subsequently complained tingling in all 4 extremities. Seen by chiropractor. Few days later lost voice, whispery and hypophonic and diagnosed with sciatica and recommended bedrest for one month. On examination: reflexes absent ankle and knee jerk bilaterally. On 29-Dec-2008: follow-up visit with neurology. It was noted that after 25-Dec-2008, patient developed left facial palsy and at time of visit nearly resolved. Voice remained with whisper and occasionally chokes on liquids. Jerky gait. Mild weaknesses throughout. On 09-Jan-2009, admitted with multiple cranial nerve palsy. Began IVIG. Discharged 13-Jan-2009. On 16-Feb-2009 patient was downgraded from GBS to CIDP (Chronic inflammatory demyelinating polyradiculoneuropathy) and was getting monthly IVIG treatments. At the time of reporting, the events of chronic inflammatory demyelinating polyneuropathy and Guillain-Barre syndrome were ongoing. The reporter assessed the chronic inflammatory demyelinating polyneuropathy and Guillain-Barre syndrome to be serious based on hospitalization.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Bed rest, Blood albumin normal, Blood creatine phosphokinase increased, CSF glucose normal, CSF protein increased
Clinical narrative: A report has been received from a health professional via VAERS (VAERS No. 337347) concerning a 6 year old female patient. No information was provided regarding relevant history, concurrent diseases and concomitant medications. The patient received FLUMIST (intranasal) on 16-Oct-2008. The patient received the flu shot in mid-October and displayed a fever during weekend in November with no other symptoms. She fell off the monkey bars at school on 13-Nov-2008 and started to complain of tingling and loss of control of limbs on right side on 14-Nov-2008. She started losing her voice 30-Nov-2008. She complained of her head tingling on 09-Dec-2008 and subsequently went to doctor on 10-Dec-2008 and had MRI, nerve conduction tests, etc and was finally diagnosed with GBS (Guillain-Barre syndrome) on about 12-Dec-2008. Medical records stated Guillain-Barre syndrome. Presented with complaints of tingling all four extremities for about 4 weeks, back pain and leg pain. Day prior to hospitalization fell from monkey bar approximately 6 feet high. Subsequently complained tingling in all 4 extremities. Seen by chiropractor. Few days later lost voice, whispery and hypophonic and diagnosed with sciatica and recommended bedrest for one month. On examination: reflexes absent ankle and knee jerk bilaterally. On 29-Dec-2008: follow-up visit with neurology. It was noted that after 25-Dec-2008, patient developed left facial palsy and at time of visit nearly resolved. Voice remained with whisper and occasionally chokes on liquids. Jerky gait. Mild weaknesses throughout. On 09-Jan-2009, admitted with multiple cranial nerve palsy. Began IVIG. Discharged 13-Jan-2009. On 16-Feb-2009 patient was downgraded from GBS to CIDP (Chronic inflammatory demyelinating polyradiculoneuropathy) and was getting monthly IVIG treatments. At the time of reporting, the events of chronic inflammatory demyelinating polyneuropathy and Guillain-Barre syndrome were ongoing. The reporter assessed the chronic inflammatory demyelinating polyneuropathy and Guillain-Barre syndrome to be serious based on hospitalization.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Choking, Chronic inflammatory demyelinating polyradiculoneuropathy, Cranial nerve palsies multiple, Dyskinesia, Dysphonia
Clinical narrative: A report has been received from a health professional via VAERS (VAERS No. 337347) concerning a 6 year old female patient. No information was provided regarding relevant history, concurrent diseases and concomitant medications. The patient received FLUMIST (intranasal) on 16-Oct-2008. The patient received the flu shot in mid-October and displayed a fever during weekend in November with no other symptoms. She fell off the monkey bars at school on 13-Nov-2008 and started to complain of tingling and loss of control of limbs on right side on 14-Nov-2008. She started losing her voice 30-Nov-2008. She complained of her head tingling on 09-Dec-2008 and subsequently went to doctor on 10-Dec-2008 and had MRI, nerve conduction tests, etc and was finally diagnosed with GBS (Guillain-Barre syndrome) on about 12-Dec-2008. Medical records stated Guillain-Barre syndrome. Presented with complaints of tingling all four extremities for about 4 weeks, back pain and leg pain. Day prior to hospitalization fell from monkey bar approximately 6 feet high. Subsequently complained tingling in all 4 extremities. Seen by chiropractor. Few days later lost voice, whispery and hypophonic and diagnosed with sciatica and recommended bedrest for one month. On examination: reflexes absent ankle and knee jerk bilaterally. On 29-Dec-2008: follow-up visit with neurology. It was noted that after 25-Dec-2008, patient developed left facial palsy and at time of visit nearly resolved. Voice remained with whisper and occasionally chokes on liquids. Jerky gait. Mild weaknesses throughout. On 09-Jan-2009, admitted with multiple cranial nerve palsy. Began IVIG. Discharged 13-Jan-2009. On 16-Feb-2009 patient was downgraded from GBS to CIDP (Chronic inflammatory demyelinating polyradiculoneuropathy) and was getting monthly IVIG treatments. At the time of reporting, the events of chronic inflammatory demyelinating polyneuropathy and Guillain-Barre syndrome were ongoing. The reporter assessed the chronic inflammatory demyelinating polyneuropathy and Guillain-Barre syndrome to be serious based on hospitalization.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Electromyogram abnormal, Fall, Full blood count normal, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: A report has been received from a health professional via VAERS (VAERS No. 337347) concerning a 6 year old female patient. No information was provided regarding relevant history, concurrent diseases and concomitant medications. The patient received FLUMIST (intranasal) on 16-Oct-2008. The patient received the flu shot in mid-October and displayed a fever during weekend in November with no other symptoms. She fell off the monkey bars at school on 13-Nov-2008 and started to complain of tingling and loss of control of limbs on right side on 14-Nov-2008. She started losing her voice 30-Nov-2008. She complained of her head tingling on 09-Dec-2008 and subsequently went to doctor on 10-Dec-2008 and had MRI, nerve conduction tests, etc and was finally diagnosed with GBS (Guillain-Barre syndrome) on about 12-Dec-2008. Medical records stated Guillain-Barre syndrome. Presented with complaints of tingling all four extremities for about 4 weeks, back pain and leg pain. Day prior to hospitalization fell from monkey bar approximately 6 feet high. Subsequently complained tingling in all 4 extremities. Seen by chiropractor. Few days later lost voice, whispery and hypophonic and diagnosed with sciatica and recommended bedrest for one month. On examination: reflexes absent ankle and knee jerk bilaterally. On 29-Dec-2008: follow-up visit with neurology. It was noted that after 25-Dec-2008, patient developed left facial palsy and at time of visit nearly resolved. Voice remained with whisper and occasionally chokes on liquids. Jerky gait. Mild weaknesses throughout. On 09-Jan-2009, admitted with multiple cranial nerve palsy. Began IVIG. Discharged 13-Jan-2009. On 16-Feb-2009 patient was downgraded from GBS to CIDP (Chronic inflammatory demyelinating polyradiculoneuropathy) and was getting monthly IVIG treatments. At the time of reporting, the events of chronic inflammatory demyelinating polyneuropathy and Guillain-Barre syndrome were ongoing. The reporter assessed the chronic inflammatory demyelinating polyneuropathy and Guillain-Barre syndrome to be serious based on hospitalization.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Immunoglobulin therapy, Metabolic function test normal, Muscular weakness, Nerve conduction studies abnormal, Nuclear magnetic resonance imaging abnormal
Clinical narrative: A report has been received from a health professional via VAERS (VAERS No. 337347) concerning a 6 year old female patient. No information was provided regarding relevant history, concurrent diseases and concomitant medications. The patient received FLUMIST (intranasal) on 16-Oct-2008. The patient received the flu shot in mid-October and displayed a fever during weekend in November with no other symptoms. She fell off the monkey bars at school on 13-Nov-2008 and started to complain of tingling and loss of control of limbs on right side on 14-Nov-2008. She started losing her voice 30-Nov-2008. She complained of her head tingling on 09-Dec-2008 and subsequently went to doctor on 10-Dec-2008 and had MRI, nerve conduction tests, etc and was finally diagnosed with GBS (Guillain-Barre syndrome) on about 12-Dec-2008. Medical records stated Guillain-Barre syndrome. Presented with complaints of tingling all four extremities for about 4 weeks, back pain and leg pain. Day prior to hospitalization fell from monkey bar approximately 6 feet high. Subsequently complained tingling in all 4 extremities. Seen by chiropractor. Few days later lost voice, whispery and hypophonic and diagnosed with sciatica and recommended bedrest for one month. On examination: reflexes absent ankle and knee jerk bilaterally. On 29-Dec-2008: follow-up visit with neurology. It was noted that after 25-Dec-2008, patient developed left facial palsy and at time of visit nearly resolved. Voice remained with whisper and occasionally chokes on liquids. Jerky gait. Mild weaknesses throughout. On 09-Jan-2009, admitted with multiple cranial nerve palsy. Began IVIG. Discharged 13-Jan-2009. On 16-Feb-2009 patient was downgraded from GBS to CIDP (Chronic inflammatory demyelinating polyradiculoneuropathy) and was getting monthly IVIG treatments. At the time of reporting, the events of chronic inflammatory demyelinating polyneuropathy and Guillain-Barre syndrome were ongoing. The reporter assessed the chronic inflammatory demyelinating polyneuropathy and Guillain-Barre syndrome to be serious based on hospitalization.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Nuclear magnetic resonance imaging normal, Pain in extremity, Paraesthesia, Protein total normal, Pyrexia
Clinical narrative: A report has been received from a health professional via VAERS (VAERS No. 337347) concerning a 6 year old female patient. No information was provided regarding relevant history, concurrent diseases and concomitant medications. The patient received FLUMIST (intranasal) on 16-Oct-2008. The patient received the flu shot in mid-October and displayed a fever during weekend in November with no other symptoms. She fell off the monkey bars at school on 13-Nov-2008 and started to complain of tingling and loss of control of limbs on right side on 14-Nov-2008. She started losing her voice 30-Nov-2008. She complained of her head tingling on 09-Dec-2008 and subsequently went to doctor on 10-Dec-2008 and had MRI, nerve conduction tests, etc and was finally diagnosed with GBS (Guillain-Barre syndrome) on about 12-Dec-2008. Medical records stated Guillain-Barre syndrome. Presented with complaints of tingling all four extremities for about 4 weeks, back pain and leg pain. Day prior to hospitalization fell from monkey bar approximately 6 feet high. Subsequently complained tingling in all 4 extremities. Seen by chiropractor. Few days later lost voice, whispery and hypophonic and diagnosed with sciatica and recommended bedrest for one month. On examination: reflexes absent ankle and knee jerk bilaterally. On 29-Dec-2008: follow-up visit with neurology. It was noted that after 25-Dec-2008, patient developed left facial palsy and at time of visit nearly resolved. Voice remained with whisper and occasionally chokes on liquids. Jerky gait. Mild weaknesses throughout. On 09-Jan-2009, admitted with multiple cranial nerve palsy. Began IVIG. Discharged 13-Jan-2009. On 16-Feb-2009 patient was downgraded from GBS to CIDP (Chronic inflammatory demyelinating polyradiculoneuropathy) and was getting monthly IVIG treatments. At the time of reporting, the events of chronic inflammatory demyelinating polyneuropathy and Guillain-Barre syndrome were ongoing. The reporter assessed the chronic inflammatory demyelinating polyneuropathy and Guillain-Barre syndrome to be serious based on hospitalization.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Sciatica, VIIth nerve paralysis
Clinical narrative: A report has been received from a health professional via VAERS (VAERS No. 337347) concerning a 6 year old female patient. No information was provided regarding relevant history, concurrent diseases and concomitant medications. The patient received FLUMIST (intranasal) on 16-Oct-2008. The patient received the flu shot in mid-October and displayed a fever during weekend in November with no other symptoms. She fell off the monkey bars at school on 13-Nov-2008 and started to complain of tingling and loss of control of limbs on right side on 14-Nov-2008. She started losing her voice 30-Nov-2008. She complained of her head tingling on 09-Dec-2008 and subsequently went to doctor on 10-Dec-2008 and had MRI, nerve conduction tests, etc and was finally diagnosed with GBS (Guillain-Barre syndrome) on about 12-Dec-2008. Medical records stated Guillain-Barre syndrome. Presented with complaints of tingling all four extremities for about 4 weeks, back pain and leg pain. Day prior to hospitalization fell from monkey bar approximately 6 feet high. Subsequently complained tingling in all 4 extremities. Seen by chiropractor. Few days later lost voice, whispery and hypophonic and diagnosed with sciatica and recommended bedrest for one month. On examination: reflexes absent ankle and knee jerk bilaterally. On 29-Dec-2008: follow-up visit with neurology. It was noted that after 25-Dec-2008, patient developed left facial palsy and at time of visit nearly resolved. Voice remained with whisper and occasionally chokes on liquids. Jerky gait. Mild weaknesses throughout. On 09-Jan-2009, admitted with multiple cranial nerve palsy. Began IVIG. Discharged 13-Jan-2009. On 16-Feb-2009 patient was downgraded from GBS to CIDP (Chronic inflammatory demyelinating polyradiculoneuropathy) and was getting monthly IVIG treatments. At the time of reporting, the events of chronic inflammatory demyelinating polyneuropathy and Guillain-Barre syndrome were ongoing. The reporter assessed the chronic inflammatory demyelinating polyneuropathy and Guillain-Barre syndrome to be serious based on hospitalization.