chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Enterovirus test negative, Epstein-Barr virus test negative, Fatigue, Full blood count, Full blood count normal
Clinical narrative: A report has been received from VAERS concerning a 7 years old male patient. The patient's medical history included VSD, aortic annulus dilatation and recurrent otitis media. Concomitant medications were not reported. On 08-Oct-2010, patient received FLUMIST (intranasal). It was reported that illness began 20 days after vaccine administration with headache, visual changes, progressive weakness, fatigue, and bilateral upper and lower extremity pain. The patient required hospitalization. Multiple labs including CSF studies were obtained as well as a brain and full spinal MRI. The patient was diagnosed with Guillain-Barre Syndrome on 28-Oct-2010, for which he received IVIG. He had required pain control, NG feedings, and physical rehabilitation. He was currently still admitted at Hospital for rehab. Patient had laboratory investigation as initial CBC, CRP, CMP, CK all within normal limits. CSF showed elevated protein (52), normal glucose, normal gram stain, no growth on culture. Negative UA. Negative Enterovirus, HSV, Mycoplasma, EBV, West Nile virus, Lyme serology. Normal T4, TSH. Normal ESR. Repeat CSF studies showed elevated protein (73), normal glucose, gram stain. CSF culture no growth. CT head normal. MRI brain normal. MRI thoracic and cervical spine normal. MRI lumbar spine with enhancement of anterior nerve roots. The outcome of the event of Guillain-Barre syndrome was unknown. Reporter considered the event of Guillain-Barre syndrome to be serious due to hospitalization and Required emergency room/doctor visit. Laboratory values and diagnostic test details are available.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Gastrointestinal tube insertion, Gram stain, Guillain-Barre syndrome, Headache, Herpes simplex serology
Clinical narrative: A report has been received from VAERS concerning a 7 years old male patient. The patient's medical history included VSD, aortic annulus dilatation and recurrent otitis media. Concomitant medications were not reported. On 08-Oct-2010, patient received FLUMIST (intranasal). It was reported that illness began 20 days after vaccine administration with headache, visual changes, progressive weakness, fatigue, and bilateral upper and lower extremity pain. The patient required hospitalization. Multiple labs including CSF studies were obtained as well as a brain and full spinal MRI. The patient was diagnosed with Guillain-Barre Syndrome on 28-Oct-2010, for which he received IVIG. He had required pain control, NG feedings, and physical rehabilitation. He was currently still admitted at Hospital for rehab. Patient had laboratory investigation as initial CBC, CRP, CMP, CK all within normal limits. CSF showed elevated protein (52), normal glucose, normal gram stain, no growth on culture. Negative UA. Negative Enterovirus, HSV, Mycoplasma, EBV, West Nile virus, Lyme serology. Normal T4, TSH. Normal ESR. Repeat CSF studies showed elevated protein (73), normal glucose, gram stain. CSF culture no growth. CT head normal. MRI brain normal. MRI thoracic and cervical spine normal. MRI lumbar spine with enhancement of anterior nerve roots. The outcome of the event of Guillain-Barre syndrome was unknown. Reporter considered the event of Guillain-Barre syndrome to be serious due to hospitalization and Required emergency room/doctor visit. Laboratory values and diagnostic test details are available.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Herpes simplex serology negative, Immunoglobulin therapy, Metabolic function test normal, Mycoplasma test, Nuclear magnetic resonance imaging brain normal
Clinical narrative: A report has been received from VAERS concerning a 7 years old male patient. The patient's medical history included VSD, aortic annulus dilatation and recurrent otitis media. Concomitant medications were not reported. On 08-Oct-2010, patient received FLUMIST (intranasal). It was reported that illness began 20 days after vaccine administration with headache, visual changes, progressive weakness, fatigue, and bilateral upper and lower extremity pain. The patient required hospitalization. Multiple labs including CSF studies were obtained as well as a brain and full spinal MRI. The patient was diagnosed with Guillain-Barre Syndrome on 28-Oct-2010, for which he received IVIG. He had required pain control, NG feedings, and physical rehabilitation. He was currently still admitted at Hospital for rehab. Patient had laboratory investigation as initial CBC, CRP, CMP, CK all within normal limits. CSF showed elevated protein (52), normal glucose, normal gram stain, no growth on culture. Negative UA. Negative Enterovirus, HSV, Mycoplasma, EBV, West Nile virus, Lyme serology. Normal T4, TSH. Normal ESR. Repeat CSF studies showed elevated protein (73), normal glucose, gram stain. CSF culture no growth. CT head normal. MRI brain normal. MRI thoracic and cervical spine normal. MRI lumbar spine with enhancement of anterior nerve roots. The outcome of the event of Guillain-Barre syndrome was unknown. Reporter considered the event of Guillain-Barre syndrome to be serious due to hospitalization and Required emergency room/doctor visit. Laboratory values and diagnostic test details are available.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Nuclear magnetic resonance imaging spinal, Nuclear magnetic resonance imaging spinal normal, Pain in extremity, Red blood cell sedimentation rate normal, Thyroxine free normal
Clinical narrative: A report has been received from VAERS concerning a 7 years old male patient. The patient's medical history included VSD, aortic annulus dilatation and recurrent otitis media. Concomitant medications were not reported. On 08-Oct-2010, patient received FLUMIST (intranasal). It was reported that illness began 20 days after vaccine administration with headache, visual changes, progressive weakness, fatigue, and bilateral upper and lower extremity pain. The patient required hospitalization. Multiple labs including CSF studies were obtained as well as a brain and full spinal MRI. The patient was diagnosed with Guillain-Barre Syndrome on 28-Oct-2010, for which he received IVIG. He had required pain control, NG feedings, and physical rehabilitation. He was currently still admitted at Hospital for rehab. Patient had laboratory investigation as initial CBC, CRP, CMP, CK all within normal limits. CSF showed elevated protein (52), normal glucose, normal gram stain, no growth on culture. Negative UA. Negative Enterovirus, HSV, Mycoplasma, EBV, West Nile virus, Lyme serology. Normal T4, TSH. Normal ESR. Repeat CSF studies showed elevated protein (73), normal glucose, gram stain. CSF culture no growth. CT head normal. MRI brain normal. MRI thoracic and cervical spine normal. MRI lumbar spine with enhancement of anterior nerve roots. The outcome of the event of Guillain-Barre syndrome was unknown. Reporter considered the event of Guillain-Barre syndrome to be serious due to hospitalization and Required emergency room/doctor visit. Laboratory values and diagnostic test details are available.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Thyroxine normal, Urine analysis normal, Visual impairment, West Nile virus test negative
Clinical narrative: A report has been received from VAERS concerning a 7 years old male patient. The patient's medical history included VSD, aortic annulus dilatation and recurrent otitis media. Concomitant medications were not reported. On 08-Oct-2010, patient received FLUMIST (intranasal). It was reported that illness began 20 days after vaccine administration with headache, visual changes, progressive weakness, fatigue, and bilateral upper and lower extremity pain. The patient required hospitalization. Multiple labs including CSF studies were obtained as well as a brain and full spinal MRI. The patient was diagnosed with Guillain-Barre Syndrome on 28-Oct-2010, for which he received IVIG. He had required pain control, NG feedings, and physical rehabilitation. He was currently still admitted at Hospital for rehab. Patient had laboratory investigation as initial CBC, CRP, CMP, CK all within normal limits. CSF showed elevated protein (52), normal glucose, normal gram stain, no growth on culture. Negative UA. Negative Enterovirus, HSV, Mycoplasma, EBV, West Nile virus, Lyme serology. Normal T4, TSH. Normal ESR. Repeat CSF studies showed elevated protein (73), normal glucose, gram stain. CSF culture no growth. CT head normal. MRI brain normal. MRI thoracic and cervical spine normal. MRI lumbar spine with enhancement of anterior nerve roots. The outcome of the event of Guillain-Barre syndrome was unknown. Reporter considered the event of Guillain-Barre syndrome to be serious due to hospitalization and Required emergency room/doctor visit. Laboratory values and diagnostic test details are available.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Asthenia, Blood albumin increased, Blood alkaline phosphatase increased, Blood creatine phosphokinase normal, Blood magnesium increased
Clinical narrative: A report has been received from physician concerning an 8 year old, female patient. The patient's concurrent diseases included upper respiratory infection. The patient had been receiving FLUMIST (intranasal) started on 28-Jan-2009. Bilateral weakness in legs and urinary difficulty, starting 2 weeks after vaccinations. Patient was hospitalized, supportive care, symptoms self-resolved. 4/20/09 MR received for DOS 2/13-16/2009 with D/C DX: Acute infective polyneuritis. Pt presented several times to PCP with c/o bilateral leg pain and weakness with difficulty urinating. PE (+) for decreased strength in legs, shotty nodes and tenderness to palpation below the knees. DTRs intact. Concern for GBS (Guillain-Barre syndrome). Referred to ER. Admitted to R/O GBS/Myositis. Pt developed neck pain 2 days s/p vax then progressed as above. F/U 2/18/09. Now able to walk on own, no urinary difficulties but still with some pain in feet. Lab data: ESR 72 mm/hr. Labs and Diagnostics: UA WNL. UC (-). CK 70. CRP 0.16. Alk Phos 240. Total protein 9.0. Albumin 5.2. CBC with WBC 12.5. ESR initially 72 then down to 16. Phosphate 5.4 (H). Mg++ 2.1 (H). X-ray lower extremities WNL. The patient recovered from the event of Guillain-Barre syndrome on an unspecified date. The reporter assessed the event Guillain-Barre syndrome to be serious with criteria of hospitalised.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Blood phosphorus increased, C-reactive protein normal, Culture urine negative, Dysuria, Full blood count
Clinical narrative: A report has been received from physician concerning an 8 year old, female patient. The patient's concurrent diseases included upper respiratory infection. The patient had been receiving FLUMIST (intranasal) started on 28-Jan-2009. Bilateral weakness in legs and urinary difficulty, starting 2 weeks after vaccinations. Patient was hospitalized, supportive care, symptoms self-resolved. 4/20/09 MR received for DOS 2/13-16/2009 with D/C DX: Acute infective polyneuritis. Pt presented several times to PCP with c/o bilateral leg pain and weakness with difficulty urinating. PE (+) for decreased strength in legs, shotty nodes and tenderness to palpation below the knees. DTRs intact. Concern for GBS (Guillain-Barre syndrome). Referred to ER. Admitted to R/O GBS/Myositis. Pt developed neck pain 2 days s/p vax then progressed as above. F/U 2/18/09. Now able to walk on own, no urinary difficulties but still with some pain in feet. Lab data: ESR 72 mm/hr. Labs and Diagnostics: UA WNL. UC (-). CK 70. CRP 0.16. Alk Phos 240. Total protein 9.0. Albumin 5.2. CBC with WBC 12.5. ESR initially 72 then down to 16. Phosphate 5.4 (H). Mg++ 2.1 (H). X-ray lower extremities WNL. The patient recovered from the event of Guillain-Barre syndrome on an unspecified date. The reporter assessed the event Guillain-Barre syndrome to be serious with criteria of hospitalised.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Guillain-Barre syndrome, Laboratory test, Lymphadenopathy, Muscular weakness, Neck pain
Clinical narrative: A report has been received from physician concerning an 8 year old, female patient. The patient's concurrent diseases included upper respiratory infection. The patient had been receiving FLUMIST (intranasal) started on 28-Jan-2009. Bilateral weakness in legs and urinary difficulty, starting 2 weeks after vaccinations. Patient was hospitalized, supportive care, symptoms self-resolved. 4/20/09 MR received for DOS 2/13-16/2009 with D/C DX: Acute infective polyneuritis. Pt presented several times to PCP with c/o bilateral leg pain and weakness with difficulty urinating. PE (+) for decreased strength in legs, shotty nodes and tenderness to palpation below the knees. DTRs intact. Concern for GBS (Guillain-Barre syndrome). Referred to ER. Admitted to R/O GBS/Myositis. Pt developed neck pain 2 days s/p vax then progressed as above. F/U 2/18/09. Now able to walk on own, no urinary difficulties but still with some pain in feet. Lab data: ESR 72 mm/hr. Labs and Diagnostics: UA WNL. UC (-). CK 70. CRP 0.16. Alk Phos 240. Total protein 9.0. Albumin 5.2. CBC with WBC 12.5. ESR initially 72 then down to 16. Phosphate 5.4 (H). Mg++ 2.1 (H). X-ray lower extremities WNL. The patient recovered from the event of Guillain-Barre syndrome on an unspecified date. The reporter assessed the event Guillain-Barre syndrome to be serious with criteria of hospitalised.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Pain in extremity, Protein total increased, Red blood cell sedimentation rate increased, Tenderness, Urine analysis normal
Clinical narrative: A report has been received from physician concerning an 8 year old, female patient. The patient's concurrent diseases included upper respiratory infection. The patient had been receiving FLUMIST (intranasal) started on 28-Jan-2009. Bilateral weakness in legs and urinary difficulty, starting 2 weeks after vaccinations. Patient was hospitalized, supportive care, symptoms self-resolved. 4/20/09 MR received for DOS 2/13-16/2009 with D/C DX: Acute infective polyneuritis. Pt presented several times to PCP with c/o bilateral leg pain and weakness with difficulty urinating. PE (+) for decreased strength in legs, shotty nodes and tenderness to palpation below the knees. DTRs intact. Concern for GBS (Guillain-Barre syndrome). Referred to ER. Admitted to R/O GBS/Myositis. Pt developed neck pain 2 days s/p vax then progressed as above. F/U 2/18/09. Now able to walk on own, no urinary difficulties but still with some pain in feet. Lab data: ESR 72 mm/hr. Labs and Diagnostics: UA WNL. UC (-). CK 70. CRP 0.16. Alk Phos 240. Total protein 9.0. Albumin 5.2. CBC with WBC 12.5. ESR initially 72 then down to 16. Phosphate 5.4 (H). Mg++ 2.1 (H). X-ray lower extremities WNL. The patient recovered from the event of Guillain-Barre syndrome on an unspecified date. The reporter assessed the event Guillain-Barre syndrome to be serious with criteria of hospitalised.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: White blood cell count increased, X-ray normal
Clinical narrative: A report has been received from physician concerning an 8 year old, female patient. The patient's concurrent diseases included upper respiratory infection. The patient had been receiving FLUMIST (intranasal) started on 28-Jan-2009. Bilateral weakness in legs and urinary difficulty, starting 2 weeks after vaccinations. Patient was hospitalized, supportive care, symptoms self-resolved. 4/20/09 MR received for DOS 2/13-16/2009 with D/C DX: Acute infective polyneuritis. Pt presented several times to PCP with c/o bilateral leg pain and weakness with difficulty urinating. PE (+) for decreased strength in legs, shotty nodes and tenderness to palpation below the knees. DTRs intact. Concern for GBS (Guillain-Barre syndrome). Referred to ER. Admitted to R/O GBS/Myositis. Pt developed neck pain 2 days s/p vax then progressed as above. F/U 2/18/09. Now able to walk on own, no urinary difficulties but still with some pain in feet. Lab data: ESR 72 mm/hr. Labs and Diagnostics: UA WNL. UC (-). CK 70. CRP 0.16. Alk Phos 240. Total protein 9.0. Albumin 5.2. CBC with WBC 12.5. ESR initially 72 then down to 16. Phosphate 5.4 (H). Mg++ 2.1 (H). X-ray lower extremities WNL. The patient recovered from the event of Guillain-Barre syndrome on an unspecified date. The reporter assessed the event Guillain-Barre syndrome to be serious with criteria of hospitalised.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Arthralgia, Asthenia, Blood alkaline phosphatase normal, Blood creatinine normal, Blood potassium increased
Clinical narrative: The report to VAERS provides the following narrative. No information was provided regarding medical history, concomitant medications and concurrent disease of the patient. Patient had been receiving FLUMIST (intranasal) started on 15-Oct-2009. Gradually developing ascending weakness culminating in admission to hospital and diagnosis of Guillain-Barre syndrome. Child has been sick 2 weeks, complained of right hip pain the day prior to admission. Now complains of weakness in legs and arms, wide gait. Absent ankle/knee jerks. Tired, irritable, stumbling and falling. IVIG administration. Dehydration. Decreased weakness, improved ambulation. Discharged. Action taken with FLUMIST was unknown. The outcome of the event of Guillain-Barre syndrome was unknown. The reporter assessed the event of Guillain-Barre syndrome to be serious with seriousness criteria of Life threatening and Hospitalised.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Blood urea increased, Borrelia test positive, CSF protein increased, Computerised tomogram head normal, Dehydration
Clinical narrative: The report to VAERS provides the following narrative. No information was provided regarding medical history, concomitant medications and concurrent disease of the patient. Patient had been receiving FLUMIST (intranasal) started on 15-Oct-2009. Gradually developing ascending weakness culminating in admission to hospital and diagnosis of Guillain-Barre syndrome. Child has been sick 2 weeks, complained of right hip pain the day prior to admission. Now complains of weakness in legs and arms, wide gait. Absent ankle/knee jerks. Tired, irritable, stumbling and falling. IVIG administration. Dehydration. Decreased weakness, improved ambulation. Discharged. Action taken with FLUMIST was unknown. The outcome of the event of Guillain-Barre syndrome was unknown. The reporter assessed the event of Guillain-Barre syndrome to be serious with seriousness criteria of Life threatening and Hospitalised.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Electrocardiogram T wave abnormal, Eosinophil percentage, Fall, Fatigue, Gait disturbance
Clinical narrative: The report to VAERS provides the following narrative. No information was provided regarding medical history, concomitant medications and concurrent disease of the patient. Patient had been receiving FLUMIST (intranasal) started on 15-Oct-2009. Gradually developing ascending weakness culminating in admission to hospital and diagnosis of Guillain-Barre syndrome. Child has been sick 2 weeks, complained of right hip pain the day prior to admission. Now complains of weakness in legs and arms, wide gait. Absent ankle/knee jerks. Tired, irritable, stumbling and falling. IVIG administration. Dehydration. Decreased weakness, improved ambulation. Discharged. Action taken with FLUMIST was unknown. The outcome of the event of Guillain-Barre syndrome was unknown. The reporter assessed the event of Guillain-Barre syndrome to be serious with seriousness criteria of Life threatening and Hospitalised.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Irritability, Laboratory test normal, Lymphocyte count increased
Clinical narrative: The report to VAERS provides the following narrative. No information was provided regarding medical history, concomitant medications and concurrent disease of the patient. Patient had been receiving FLUMIST (intranasal) started on 15-Oct-2009. Gradually developing ascending weakness culminating in admission to hospital and diagnosis of Guillain-Barre syndrome. Child has been sick 2 weeks, complained of right hip pain the day prior to admission. Now complains of weakness in legs and arms, wide gait. Absent ankle/knee jerks. Tired, irritable, stumbling and falling. IVIG administration. Dehydration. Decreased weakness, improved ambulation. Discharged. Action taken with FLUMIST was unknown. The outcome of the event of Guillain-Barre syndrome was unknown. The reporter assessed the event of Guillain-Barre syndrome to be serious with seriousness criteria of Life threatening and Hospitalised.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Lymphocyte percentage increased, Malaise, Muscular weakness, Platelet count increased, Red blood cells urine
Clinical narrative: The report to VAERS provides the following narrative. No information was provided regarding medical history, concomitant medications and concurrent disease of the patient. Patient had been receiving FLUMIST (intranasal) started on 15-Oct-2009. Gradually developing ascending weakness culminating in admission to hospital and diagnosis of Guillain-Barre syndrome. Child has been sick 2 weeks, complained of right hip pain the day prior to admission. Now complains of weakness in legs and arms, wide gait. Absent ankle/knee jerks. Tired, irritable, stumbling and falling. IVIG administration. Dehydration. Decreased weakness, improved ambulation. Discharged. Action taken with FLUMIST was unknown. The outcome of the event of Guillain-Barre syndrome was unknown. The reporter assessed the event of Guillain-Barre syndrome to be serious with seriousness criteria of Life threatening and Hospitalised.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Red blood cells urine positive, Red cell distribution width normal, Urinary sediment present, Urine abnormality, White blood cells urine positive
Clinical narrative: The report to VAERS provides the following narrative. No information was provided regarding medical history, concomitant medications and concurrent disease of the patient. Patient had been receiving FLUMIST (intranasal) started on 15-Oct-2009. Gradually developing ascending weakness culminating in admission to hospital and diagnosis of Guillain-Barre syndrome. Child has been sick 2 weeks, complained of right hip pain the day prior to admission. Now complains of weakness in legs and arms, wide gait. Absent ankle/knee jerks. Tired, irritable, stumbling and falling. IVIG administration. Dehydration. Decreased weakness, improved ambulation. Discharged. Action taken with FLUMIST was unknown. The outcome of the event of Guillain-Barre syndrome was unknown. The reporter assessed the event of Guillain-Barre syndrome to be serious with seriousness criteria of Life threatening and Hospitalised.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: pH urine normal
Clinical narrative: The report to VAERS provides the following narrative. No information was provided regarding medical history, concomitant medications and concurrent disease of the patient. Patient had been receiving FLUMIST (intranasal) started on 15-Oct-2009. Gradually developing ascending weakness culminating in admission to hospital and diagnosis of Guillain-Barre syndrome. Child has been sick 2 weeks, complained of right hip pain the day prior to admission. Now complains of weakness in legs and arms, wide gait. Absent ankle/knee jerks. Tired, irritable, stumbling and falling. IVIG administration. Dehydration. Decreased weakness, improved ambulation. Discharged. Action taken with FLUMIST was unknown. The outcome of the event of Guillain-Barre syndrome was unknown. The reporter assessed the event of Guillain-Barre syndrome to be serious with seriousness criteria of Life threatening and Hospitalised.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Abasia, Abnormal behaviour, Aphagia, Aphasia, Delirium
Clinical narrative: A spontaneous report has been received from a consumer via Regulatory Authority (VAERS) concerning a 45 month old female patient. Neither concomitant medications nor medical history were reported for this patient. The patient had received influenza vaccination shot in the past. Around 09-Oct-2009, this patient received a first dose of FLUMIST (intranasal). On 06-Nov-2009, the patient received a second dose of FLUMIST (intranasal). On 08-Nov-2009, the patient experienced behavioral issues that persisted for several days and patient had encephalopathy. The patient could Not sleep, was very irritable and experienced delirium for about a week with nightmares. The patient also experienced fever of 103 F for two weeks and vomiting for five days after fever onset. On 26-Nov-2009 the patient experienced uncontrollable drooling and was unable to swallow. The patient was taken to emergency room and diagnosed with sore throat and sent home. On 27-Nov-2009 the patient did not improve and was admitted to hospital. It was reported the patient had a feeding tube, was unable to speak and unable to walk or sit up on her own. During the hospitalization the patient had multiple MRIs and two lumbar punctures, although no results were provided. The patient remains hospitalized and the reported events were ongoing. The reporter assessed the events encephalopathy to be serious with the seriousness criteria of Hospitalization and other events to be non-serious.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Drooling, Encephalopathy, Gastrointestinal tube insertion, Insomnia, Irritability
Clinical narrative: A spontaneous report has been received from a consumer via Regulatory Authority (VAERS) concerning a 45 month old female patient. Neither concomitant medications nor medical history were reported for this patient. The patient had received influenza vaccination shot in the past. Around 09-Oct-2009, this patient received a first dose of FLUMIST (intranasal). On 06-Nov-2009, the patient received a second dose of FLUMIST (intranasal). On 08-Nov-2009, the patient experienced behavioral issues that persisted for several days and patient had encephalopathy. The patient could Not sleep, was very irritable and experienced delirium for about a week with nightmares. The patient also experienced fever of 103 F for two weeks and vomiting for five days after fever onset. On 26-Nov-2009 the patient experienced uncontrollable drooling and was unable to swallow. The patient was taken to emergency room and diagnosed with sore throat and sent home. On 27-Nov-2009 the patient did not improve and was admitted to hospital. It was reported the patient had a feeding tube, was unable to speak and unable to walk or sit up on her own. During the hospitalization the patient had multiple MRIs and two lumbar punctures, although no results were provided. The patient remains hospitalized and the reported events were ongoing. The reporter assessed the events encephalopathy to be serious with the seriousness criteria of Hospitalization and other events to be non-serious.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Lumbar puncture, Nightmare, Nuclear magnetic resonance imaging, Oropharyngeal pain, Pyrexia
Clinical narrative: A spontaneous report has been received from a consumer via Regulatory Authority (VAERS) concerning a 45 month old female patient. Neither concomitant medications nor medical history were reported for this patient. The patient had received influenza vaccination shot in the past. Around 09-Oct-2009, this patient received a first dose of FLUMIST (intranasal). On 06-Nov-2009, the patient received a second dose of FLUMIST (intranasal). On 08-Nov-2009, the patient experienced behavioral issues that persisted for several days and patient had encephalopathy. The patient could Not sleep, was very irritable and experienced delirium for about a week with nightmares. The patient also experienced fever of 103 F for two weeks and vomiting for five days after fever onset. On 26-Nov-2009 the patient experienced uncontrollable drooling and was unable to swallow. The patient was taken to emergency room and diagnosed with sore throat and sent home. On 27-Nov-2009 the patient did not improve and was admitted to hospital. It was reported the patient had a feeding tube, was unable to speak and unable to walk or sit up on her own. During the hospitalization the patient had multiple MRIs and two lumbar punctures, although no results were provided. The patient remains hospitalized and the reported events were ongoing. The reporter assessed the events encephalopathy to be serious with the seriousness criteria of Hospitalization and other events to be non-serious.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Vomiting
Clinical narrative: A spontaneous report has been received from a consumer via Regulatory Authority (VAERS) concerning a 45 month old female patient. Neither concomitant medications nor medical history were reported for this patient. The patient had received influenza vaccination shot in the past. Around 09-Oct-2009, this patient received a first dose of FLUMIST (intranasal). On 06-Nov-2009, the patient received a second dose of FLUMIST (intranasal). On 08-Nov-2009, the patient experienced behavioral issues that persisted for several days and patient had encephalopathy. The patient could Not sleep, was very irritable and experienced delirium for about a week with nightmares. The patient also experienced fever of 103 F for two weeks and vomiting for five days after fever onset. On 26-Nov-2009 the patient experienced uncontrollable drooling and was unable to swallow. The patient was taken to emergency room and diagnosed with sore throat and sent home. On 27-Nov-2009 the patient did not improve and was admitted to hospital. It was reported the patient had a feeding tube, was unable to speak and unable to walk or sit up on her own. During the hospitalization the patient had multiple MRIs and two lumbar punctures, although no results were provided. The patient remains hospitalized and the reported events were ongoing. The reporter assessed the events encephalopathy to be serious with the seriousness criteria of Hospitalization and other events to be non-serious.
Age: 17.0
Sex: M
Vaccine: FLUN3
Symptoms: Adenovirus test, Bronchoscopy, CSF culture negative, CSF glucose normal, CSF lymphocyte count increased
Clinical narrative: A spontaneous report has been received from VAERS concerning a 17 year old, male patient. Concomitant medications included hepatitis A vaccine, hepatitis B vaccine, pneumococcal vaccine and meningococcal polysaccharide. Patient had been receiving FLUMIST (intranasal) (Non AZ Product), started on 15-Jun-2009, Lot number - U2791DA. Patient was brought in for syncope. Was told he passed. States he has been having, night sweats, coughing up blood-quarter size amount of blood at night, and loose bowel movements for past 3 weeks. He has been having decrease in appetite and a 26lb weight loss since starting training. Denies of any CP or SOB. However, has been having and dysuria with increase in frequency. Patient had clinical picture consistent with meningoencephalitis. Lumbar puncture performed showed elevated protein and lymphocytes. CSF culture and gram stain were negative. Patient started on and completed full courses of vancomycin, ceftriaxone, doxycycline, fluconazole, acyclovir, TAMIFLU, steroids and IVIG. All of patients CSF lab tests for possible causes of meningoencephalitis (sent to state encephalitis project) have returned negative; tests included HSV 1 and 2, VZV, enterovirus, adenovirus, influenza, parainfluenza, WNV, EBV, CMV, and coccidioidomycosis Ag. CSF pathology negative for malignancy and parasites. Patient developed evidence of opacity of left lower lobe on 23-Jul-2009. Felt to be a result of aspiration pneumonia. Patient had following Lab test as: 18-Jul-2009- non contrast head CT- no evidence of acute intracranial hemorrhage or parenchymal mass. 18-Jul-2009 lumbar puncture: 79 WBC, 9 RBC, glucose 60, lymphocyte predominance, few PMNs, no organisms seen, culture negative. 20-Jul-2009- MRI of brain- negative MRI examination of the brain, without evidence of abnormal enhancement, specifically of the meninges or temporal horns. 20-Jul-2009 EEG: diffuse slowing which was nonspecific for cerebral dysfunction. 22-Jul-2009: testicular ultrasound: essentially normal testicular ultrasound without evidence of a primary malignancy. 22-Jul-2009: bronchoscopy: mucus plugs in left lung. Culture and gram stain negative. 04-Aug-2009: bronchoscopy for mucus plug removal. 27-Jul-09: MRI of T spine: impression: evidence of subarach. Patient treated with vancomycin, ceftriaxone, and doxycycline. Most recent CXR shows resolution of opacity. At the time of reporting, the events of meningoencephalitis, syncope and aspiration pneumonia was ongoing. The reporter assessed the event of meningoencephalitis to be serious with seriousness criteria of disability and hospitalized and events of syncope and aspiration pneumonia to be serious with seriousness criteria of hospitalized. Corrected report 16-Apr-2015: It has been confirmed by Product Complaints on 31-Mar-15 that the lot number listed (U2791DA) for case 2015SE18951 is not a lot for FLUMIST. Initial unit corrected. Name of manufacturer changed to Unknown.
Age: 17.0
Sex: M
Vaccine: FLUN3
Symptoms: CSF protein increased, CSF red blood cell count positive, CSF white blood cell count increased, Chest X-ray abnormal, Computerised tomogram head normal
Clinical narrative: A spontaneous report has been received from VAERS concerning a 17 year old, male patient. Concomitant medications included hepatitis A vaccine, hepatitis B vaccine, pneumococcal vaccine and meningococcal polysaccharide. Patient had been receiving FLUMIST (intranasal) (Non AZ Product), started on 15-Jun-2009, Lot number - U2791DA. Patient was brought in for syncope. Was told he passed. States he has been having, night sweats, coughing up blood-quarter size amount of blood at night, and loose bowel movements for past 3 weeks. He has been having decrease in appetite and a 26lb weight loss since starting training. Denies of any CP or SOB. However, has been having and dysuria with increase in frequency. Patient had clinical picture consistent with meningoencephalitis. Lumbar puncture performed showed elevated protein and lymphocytes. CSF culture and gram stain were negative. Patient started on and completed full courses of vancomycin, ceftriaxone, doxycycline, fluconazole, acyclovir, TAMIFLU, steroids and IVIG. All of patients CSF lab tests for possible causes of meningoencephalitis (sent to state encephalitis project) have returned negative; tests included HSV 1 and 2, VZV, enterovirus, adenovirus, influenza, parainfluenza, WNV, EBV, CMV, and coccidioidomycosis Ag. CSF pathology negative for malignancy and parasites. Patient developed evidence of opacity of left lower lobe on 23-Jul-2009. Felt to be a result of aspiration pneumonia. Patient had following Lab test as: 18-Jul-2009- non contrast head CT- no evidence of acute intracranial hemorrhage or parenchymal mass. 18-Jul-2009 lumbar puncture: 79 WBC, 9 RBC, glucose 60, lymphocyte predominance, few PMNs, no organisms seen, culture negative. 20-Jul-2009- MRI of brain- negative MRI examination of the brain, without evidence of abnormal enhancement, specifically of the meninges or temporal horns. 20-Jul-2009 EEG: diffuse slowing which was nonspecific for cerebral dysfunction. 22-Jul-2009: testicular ultrasound: essentially normal testicular ultrasound without evidence of a primary malignancy. 22-Jul-2009: bronchoscopy: mucus plugs in left lung. Culture and gram stain negative. 04-Aug-2009: bronchoscopy for mucus plug removal. 27-Jul-09: MRI of T spine: impression: evidence of subarach. Patient treated with vancomycin, ceftriaxone, and doxycycline. Most recent CXR shows resolution of opacity. At the time of reporting, the events of meningoencephalitis, syncope and aspiration pneumonia was ongoing. The reporter assessed the event of meningoencephalitis to be serious with seriousness criteria of disability and hospitalized and events of syncope and aspiration pneumonia to be serious with seriousness criteria of hospitalized. Corrected report 16-Apr-2015: It has been confirmed by Product Complaints on 31-Mar-15 that the lot number listed (U2791DA) for case 2015SE18951 is not a lot for FLUMIST. Initial unit corrected. Name of manufacturer changed to Unknown.
Age: 17.0
Sex: M
Vaccine: FLUN3
Symptoms: Cytomegalovirus test negative, Decreased appetite, Diarrhoea, Dysuria, Electroencephalogram abnormal
Clinical narrative: A spontaneous report has been received from VAERS concerning a 17 year old, male patient. Concomitant medications included hepatitis A vaccine, hepatitis B vaccine, pneumococcal vaccine and meningococcal polysaccharide. Patient had been receiving FLUMIST (intranasal) (Non AZ Product), started on 15-Jun-2009, Lot number - U2791DA. Patient was brought in for syncope. Was told he passed. States he has been having, night sweats, coughing up blood-quarter size amount of blood at night, and loose bowel movements for past 3 weeks. He has been having decrease in appetite and a 26lb weight loss since starting training. Denies of any CP or SOB. However, has been having and dysuria with increase in frequency. Patient had clinical picture consistent with meningoencephalitis. Lumbar puncture performed showed elevated protein and lymphocytes. CSF culture and gram stain were negative. Patient started on and completed full courses of vancomycin, ceftriaxone, doxycycline, fluconazole, acyclovir, TAMIFLU, steroids and IVIG. All of patients CSF lab tests for possible causes of meningoencephalitis (sent to state encephalitis project) have returned negative; tests included HSV 1 and 2, VZV, enterovirus, adenovirus, influenza, parainfluenza, WNV, EBV, CMV, and coccidioidomycosis Ag. CSF pathology negative for malignancy and parasites. Patient developed evidence of opacity of left lower lobe on 23-Jul-2009. Felt to be a result of aspiration pneumonia. Patient had following Lab test as: 18-Jul-2009- non contrast head CT- no evidence of acute intracranial hemorrhage or parenchymal mass. 18-Jul-2009 lumbar puncture: 79 WBC, 9 RBC, glucose 60, lymphocyte predominance, few PMNs, no organisms seen, culture negative. 20-Jul-2009- MRI of brain- negative MRI examination of the brain, without evidence of abnormal enhancement, specifically of the meninges or temporal horns. 20-Jul-2009 EEG: diffuse slowing which was nonspecific for cerebral dysfunction. 22-Jul-2009: testicular ultrasound: essentially normal testicular ultrasound without evidence of a primary malignancy. 22-Jul-2009: bronchoscopy: mucus plugs in left lung. Culture and gram stain negative. 04-Aug-2009: bronchoscopy for mucus plug removal. 27-Jul-09: MRI of T spine: impression: evidence of subarach. Patient treated with vancomycin, ceftriaxone, and doxycycline. Most recent CXR shows resolution of opacity. At the time of reporting, the events of meningoencephalitis, syncope and aspiration pneumonia was ongoing. The reporter assessed the event of meningoencephalitis to be serious with seriousness criteria of disability and hospitalized and events of syncope and aspiration pneumonia to be serious with seriousness criteria of hospitalized. Corrected report 16-Apr-2015: It has been confirmed by Product Complaints on 31-Mar-15 that the lot number listed (U2791DA) for case 2015SE18951 is not a lot for FLUMIST. Initial unit corrected. Name of manufacturer changed to Unknown.
Age: 17.0
Sex: M
Vaccine: FLUN3
Symptoms: Encephalitis, Enterovirus test negative, Epstein-Barr virus test negative, Gram stain negative, Haemoptysis
Clinical narrative: A spontaneous report has been received from VAERS concerning a 17 year old, male patient. Concomitant medications included hepatitis A vaccine, hepatitis B vaccine, pneumococcal vaccine and meningococcal polysaccharide. Patient had been receiving FLUMIST (intranasal) (Non AZ Product), started on 15-Jun-2009, Lot number - U2791DA. Patient was brought in for syncope. Was told he passed. States he has been having, night sweats, coughing up blood-quarter size amount of blood at night, and loose bowel movements for past 3 weeks. He has been having decrease in appetite and a 26lb weight loss since starting training. Denies of any CP or SOB. However, has been having and dysuria with increase in frequency. Patient had clinical picture consistent with meningoencephalitis. Lumbar puncture performed showed elevated protein and lymphocytes. CSF culture and gram stain were negative. Patient started on and completed full courses of vancomycin, ceftriaxone, doxycycline, fluconazole, acyclovir, TAMIFLU, steroids and IVIG. All of patients CSF lab tests for possible causes of meningoencephalitis (sent to state encephalitis project) have returned negative; tests included HSV 1 and 2, VZV, enterovirus, adenovirus, influenza, parainfluenza, WNV, EBV, CMV, and coccidioidomycosis Ag. CSF pathology negative for malignancy and parasites. Patient developed evidence of opacity of left lower lobe on 23-Jul-2009. Felt to be a result of aspiration pneumonia. Patient had following Lab test as: 18-Jul-2009- non contrast head CT- no evidence of acute intracranial hemorrhage or parenchymal mass. 18-Jul-2009 lumbar puncture: 79 WBC, 9 RBC, glucose 60, lymphocyte predominance, few PMNs, no organisms seen, culture negative. 20-Jul-2009- MRI of brain- negative MRI examination of the brain, without evidence of abnormal enhancement, specifically of the meninges or temporal horns. 20-Jul-2009 EEG: diffuse slowing which was nonspecific for cerebral dysfunction. 22-Jul-2009: testicular ultrasound: essentially normal testicular ultrasound without evidence of a primary malignancy. 22-Jul-2009: bronchoscopy: mucus plugs in left lung. Culture and gram stain negative. 04-Aug-2009: bronchoscopy for mucus plug removal. 27-Jul-09: MRI of T spine: impression: evidence of subarach. Patient treated with vancomycin, ceftriaxone, and doxycycline. Most recent CXR shows resolution of opacity. At the time of reporting, the events of meningoencephalitis, syncope and aspiration pneumonia was ongoing. The reporter assessed the event of meningoencephalitis to be serious with seriousness criteria of disability and hospitalized and events of syncope and aspiration pneumonia to be serious with seriousness criteria of hospitalized. Corrected report 16-Apr-2015: It has been confirmed by Product Complaints on 31-Mar-15 that the lot number listed (U2791DA) for case 2015SE18951 is not a lot for FLUMIST. Initial unit corrected. Name of manufacturer changed to Unknown.
Age: 17.0
Sex: M
Vaccine: FLUN3
Symptoms: Herpes simplex serology negative, Immunoglobulin therapy, Influenza virus test negative, Night sweats, Nuclear magnetic resonance imaging brain normal
Clinical narrative: A spontaneous report has been received from VAERS concerning a 17 year old, male patient. Concomitant medications included hepatitis A vaccine, hepatitis B vaccine, pneumococcal vaccine and meningococcal polysaccharide. Patient had been receiving FLUMIST (intranasal) (Non AZ Product), started on 15-Jun-2009, Lot number - U2791DA. Patient was brought in for syncope. Was told he passed. States he has been having, night sweats, coughing up blood-quarter size amount of blood at night, and loose bowel movements for past 3 weeks. He has been having decrease in appetite and a 26lb weight loss since starting training. Denies of any CP or SOB. However, has been having and dysuria with increase in frequency. Patient had clinical picture consistent with meningoencephalitis. Lumbar puncture performed showed elevated protein and lymphocytes. CSF culture and gram stain were negative. Patient started on and completed full courses of vancomycin, ceftriaxone, doxycycline, fluconazole, acyclovir, TAMIFLU, steroids and IVIG. All of patients CSF lab tests for possible causes of meningoencephalitis (sent to state encephalitis project) have returned negative; tests included HSV 1 and 2, VZV, enterovirus, adenovirus, influenza, parainfluenza, WNV, EBV, CMV, and coccidioidomycosis Ag. CSF pathology negative for malignancy and parasites. Patient developed evidence of opacity of left lower lobe on 23-Jul-2009. Felt to be a result of aspiration pneumonia. Patient had following Lab test as: 18-Jul-2009- non contrast head CT- no evidence of acute intracranial hemorrhage or parenchymal mass. 18-Jul-2009 lumbar puncture: 79 WBC, 9 RBC, glucose 60, lymphocyte predominance, few PMNs, no organisms seen, culture negative. 20-Jul-2009- MRI of brain- negative MRI examination of the brain, without evidence of abnormal enhancement, specifically of the meninges or temporal horns. 20-Jul-2009 EEG: diffuse slowing which was nonspecific for cerebral dysfunction. 22-Jul-2009: testicular ultrasound: essentially normal testicular ultrasound without evidence of a primary malignancy. 22-Jul-2009: bronchoscopy: mucus plugs in left lung. Culture and gram stain negative. 04-Aug-2009: bronchoscopy for mucus plug removal. 27-Jul-09: MRI of T spine: impression: evidence of subarach. Patient treated with vancomycin, ceftriaxone, and doxycycline. Most recent CXR shows resolution of opacity. At the time of reporting, the events of meningoencephalitis, syncope and aspiration pneumonia was ongoing. The reporter assessed the event of meningoencephalitis to be serious with seriousness criteria of disability and hospitalized and events of syncope and aspiration pneumonia to be serious with seriousness criteria of hospitalized. Corrected report 16-Apr-2015: It has been confirmed by Product Complaints on 31-Mar-15 that the lot number listed (U2791DA) for case 2015SE18951 is not a lot for FLUMIST. Initial unit corrected. Name of manufacturer changed to Unknown.