chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: FLUN3, FLUN3, HEP, HEPA, YF
Symptoms: Dyspnoea, Throat tightness, Urticaria
Clinical narrative: This is a verbatim narrative as reported on web site, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. "FLUMIST problem was reported on Dec 07, 2007. Female patient, 23 years of age, was vaccinated with FLUMIST on Dec 07, 2007. "Patient exhibited hives difficulty breathing and felt like her throat was closing up greater that a hour after receiving vaccinations. Pt went to facility and received BENADRYL, SOLUMEDROL and epinephrine and albuterol nebulizer and IV fluids. Patient recovered." The sponsor assessed the above described events as consistent with a hypersensitivity reaction; therefore, the events are considered labeled.
Age: 23.0
Sex: F
Vaccine: FLUN3, FLUN3, HEP, HEPA, YF
Symptoms: Anaphylactic reaction, Cough, Dyspnoea, Pharyngeal oedema, Pruritus
Clinical narrative: This is a verbatim narrative as reported on web site, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. "FLUMIST problem was reported on Dec 07, 2007. Female patient, 23 years of age, was vaccinated with FLUMIST on Dec 07, 2007. "Patient exhibited hives difficulty breathing and felt like her throat was closing up greater that a hour after receiving vaccinations. Pt went to facility and received BENADRYL, SOLUMEDROL and epinephrine and albuterol nebulizer and IV fluids. Patient recovered." The sponsor assessed the above described events as consistent with a hypersensitivity reaction; therefore, the events are considered labeled.
Age: 23.0
Sex: F
Vaccine: FLUN3, FLUN3, HEP, HEPA, YF
Symptoms: Tongue oedema, Urticaria
Clinical narrative: This is a verbatim narrative as reported on web site, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. "FLUMIST problem was reported on Dec 07, 2007. Female patient, 23 years of age, was vaccinated with FLUMIST on Dec 07, 2007. "Patient exhibited hives difficulty breathing and felt like her throat was closing up greater that a hour after receiving vaccinations. Pt went to facility and received BENADRYL, SOLUMEDROL and epinephrine and albuterol nebulizer and IV fluids. Patient recovered." The sponsor assessed the above described events as consistent with a hypersensitivity reaction; therefore, the events are considered labeled.
Age: 23.0
Sex: F
Vaccine: FLUN3, FLUN3, HEP, HEPA, YF
Symptoms: Dyspnoea, Throat tightness, Urticaria
Clinical narrative: This is a verbatim narrative as reported, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. "FLUMIST problem was reported on Dec 26, 2007. Female patient, 23 years of age, was vaccinated with FLUMIST on Dec 26, 2007. "23 yo healthy F with acute onset of coughing, dyspnea, glossal/pharyngeal edema, pruritis and hives 20 minutes after receiving 4 immunizations at immunization clinic (Yellow Fever, Influenza, Hepatitis A and B). Pt was sent to healthcare facility where she was treated with Oxygen, BENADRYL 50mg x 2, SOLUMEDROL 125mg x2, Albuterol neb, and epinephrine 0.3mg subcut, 2L NS. Pt states she began to feel better after treatment and had no recurrence of symptoms. After pt was stabilized she was transferred to hospital for observation and was than transferred for continued observation for refractory symptoms. 12/27/2007 MR received for ER visit 12/7-8/2007 with D/C DX: Anaphylactic Reaction to Immunization. Pt developed acute onset of coughing, dyspnea, glossal/pharyngeal edema, hives and pruritis w/in 20 minutes of 4 vax. Pt txd with EPI, BENADRYL, SOLUMEDROL and albuterol. Developed more hives. Observed o/n with no refractory sx.". "ZYRTEC, ZANTAC". None. Patient was hospitalized. Patient recovered."
Age: 23.0
Sex: F
Vaccine: FLUN3, FLUN3, HEP, HEPA, YF
Symptoms: Anaphylactic reaction, Cough, Dyspnoea, Pharyngeal oedema, Pruritus
Clinical narrative: This is a verbatim narrative as reported, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. "FLUMIST problem was reported on Dec 26, 2007. Female patient, 23 years of age, was vaccinated with FLUMIST on Dec 26, 2007. "23 yo healthy F with acute onset of coughing, dyspnea, glossal/pharyngeal edema, pruritis and hives 20 minutes after receiving 4 immunizations at immunization clinic (Yellow Fever, Influenza, Hepatitis A and B). Pt was sent to healthcare facility where she was treated with Oxygen, BENADRYL 50mg x 2, SOLUMEDROL 125mg x2, Albuterol neb, and epinephrine 0.3mg subcut, 2L NS. Pt states she began to feel better after treatment and had no recurrence of symptoms. After pt was stabilized she was transferred to hospital for observation and was than transferred for continued observation for refractory symptoms. 12/27/2007 MR received for ER visit 12/7-8/2007 with D/C DX: Anaphylactic Reaction to Immunization. Pt developed acute onset of coughing, dyspnea, glossal/pharyngeal edema, hives and pruritis w/in 20 minutes of 4 vax. Pt txd with EPI, BENADRYL, SOLUMEDROL and albuterol. Developed more hives. Observed o/n with no refractory sx.". "ZYRTEC, ZANTAC". None. Patient was hospitalized. Patient recovered."
Age: 23.0
Sex: F
Vaccine: FLUN3, FLUN3, HEP, HEPA, YF
Symptoms: Tongue oedema, Urticaria
Clinical narrative: This is a verbatim narrative as reported, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. "FLUMIST problem was reported on Dec 26, 2007. Female patient, 23 years of age, was vaccinated with FLUMIST on Dec 26, 2007. "23 yo healthy F with acute onset of coughing, dyspnea, glossal/pharyngeal edema, pruritis and hives 20 minutes after receiving 4 immunizations at immunization clinic (Yellow Fever, Influenza, Hepatitis A and B). Pt was sent to healthcare facility where she was treated with Oxygen, BENADRYL 50mg x 2, SOLUMEDROL 125mg x2, Albuterol neb, and epinephrine 0.3mg subcut, 2L NS. Pt states she began to feel better after treatment and had no recurrence of symptoms. After pt was stabilized she was transferred to hospital for observation and was than transferred for continued observation for refractory symptoms. 12/27/2007 MR received for ER visit 12/7-8/2007 with D/C DX: Anaphylactic Reaction to Immunization. Pt developed acute onset of coughing, dyspnea, glossal/pharyngeal edema, hives and pruritis w/in 20 minutes of 4 vax. Pt txd with EPI, BENADRYL, SOLUMEDROL and albuterol. Developed more hives. Observed o/n with no refractory sx.". "ZYRTEC, ZANTAC". None. Patient was hospitalized. Patient recovered."
Age: 28.0
Sex: M
Vaccine: FLUN3
Symptoms: Burning sensation, Erythema, Headache, Inflammation, Pruritus
Clinical narrative: This is a verbatim narrative as reported on website, accessed on 28 July 2011. According to web site these reports were from FDA VAERS."FLUMIST problem was reported on Dec 11, 2007. Male patient, 28 years of age, was vaccinated with FLUMIST on Dec 04, 2007, "2 days since vaccination, inflammation/burning intensely/itchiness/redness/headache."... Patient recovered."
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Decreased appetite, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: This is a verbatim narrative as reported on web site, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. "FLUMIST problem was reported on Dec 14, 2007. Female patient, child 5 years of age, was vaccinated with FLUMIST on Dec 12, 2007. "Syndrome of headache, sore throat, fever, and decreased appetite." None. Patient recovered."
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Decreased appetite, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: This is a verbatim narrative as reported on web site, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. "FLUMIST problem was reported on Dec 14, 2007. Male patient, child 4 years of age, was vaccinated with FLUMIST on Dec 12, 2007. "Symptoms include headache, sore throat, fever and decreased appetite. Fever was up to 102.5." None. NKA. Patient recovered." This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 25.0
Sex: F
Vaccine: FLUN3
Symptoms: Paraesthesia, Rash
Clinical narrative: This is a verbatim narrative as reported on web site, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. "FLUMIST problem was reported on Dec 17, 2007. Female patient, 25 years of age, was vaccinated with FLUMIST on Dec 17, 2007. Pt received FLUMIST inhalation on 12/13/2007. Pt c/o if facial tingling within 10 minutes of vaccination. Pt waited in vaccination area for approximately 20 minutes. She then left and returned 20 more minutes later c/o a fine rash on her left arm and face. Pt was instructed to have someone drive her to the clinic...LO/OVRAL. Unknown. Patient recovered.
Age: 23.0
Sex: M
Vaccine: FLUN3
Symptoms: Condition aggravated, Pyrexia, Respiratory tract congestion, Upper respiratory tract infection
Clinical narrative: This is a verbatim narrative as reported on a website, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. "FLUMIST problem was reported from hospital on Dec 18, 2007. Male patient, 23 years of age, was vaccinated with FLUMIST on Dec 18, 2007. "States he felt congested and feverish prior to flu mist administration. Temp was taken prior to flu mist was 98.8 by medical rep. Went to another medical rep for the flu mist administration and answered all questions on the flu mist questionnaire as no. After being administered the flu mist, states he progressively felt worse until Sunday night about 7 PM, he headed to the ER. Stated his chest was further congested and he was feeling even more feverish. At ER, he was diagnosed with an upper respiratory infection and told to go home and drink fluids and rest. By Tuesday Dec 11th, was feeling better." "Complained of chest congestion and feeling feverish prior to flu mist administration....Patient recovered."
Age: 1.6
Sex: M
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This is a verbatim narrative as reported on web site, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. "FLUMIST problem was reported on Dec 19, 2007. Male patient, child 1.5 years of age, was vaccinated with FLUMIST on Dec 19, 2007. FLUMIST given out of age criteria.. None.. Patient recovered." This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 0.99
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This is a verbatim narrative as reported on web site, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. "FLUMIST problem was reported on Dec 19, 2007. Female patient, child 0.9 years of age, was vaccinated with FLUMIST on Dec 19, 4007. FLUMIST was given out of age criteria..MOTRIN.. Patient recovered. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 15.0
Sex: F
Vaccine: FLUN3
Symptoms: Oedema peripheral
Clinical narrative: This is a verbatim narrative as reported on website, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. "FLUMIST problem was reported on Dec 23, 2007. Female patient, 15 years of age, was vaccinated with FLUMIST on Dec 23, 2007. Entire left arm swelled 2 days after receiving 3rd GARDASIL injection. Received ibuprofen and ice..."ZOLOFT 50 mg per day. SEASONIQUE, NEXIUM 40 mg twice daily."..."esophagitis, dysmenorrhea, depression." Patient recovered."
Age: 15.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, TDAP
Symptoms: Head injury, Syncope
Clinical narrative: "This is a verbatim narrative as reported to the FDA VAERS:" "Information has been received from a physician concerning a 15 year old female who was vaccinated (route, site and dosage not reported) with GARDASIL (lot # not reported). Concomitant therapy included MENACTRA, FLUMIST and ADACEL given on the same day. Post vaccination, the patient stood up and started talking and subsequently fainted. The patient fully recovered. Additional information has been requested. Information has been received from a physician and follow-up information from a nurse concerning a 15 year old female with no relevant medical history [sic], known drug allergies or illnesses at time of vaccination who in 17-NOV-2007, at 11:00 am was vaccinated intramuscularly in the deltoid muscle of the upper left arm with the first 0.5 ml dose of GARDASIL (lot # 658283/0929U). The patient was concomitantly [sic] vaccinated with MENACTRA (lot #62403AA) given intramuscularly in the deltoid muscle of the lower left arm, FLUMIST (Lot #500489P) given intramuscularly (sic) and ADACEL (lot #C2771AA) given intramuscularly in the deltoid muscle of the right arm. The patient fainted post vaccinations. At 11:10 am the patient stood up walked over to the other side of the room on the ground for approx 30 seconds. The patient came to and started talking. The CRNP came in to the room immediately and gave the patient some water and ice pack for the red area on her forehead. The patient's mother was instructed to watch patient carefully for 48-72 hours. The reporter stated that if the patient started to vomit, get a severe headache, sleeping too much the patient should go to the emergency room [sic]. No lab diagnostic test were performed. The patient left the office and was fine. The patient fully recovered. No additional information is expected."
Age: 2.9
Sex: F
Vaccine: FLUN3
Symptoms: Asthma, Cough, Ear infection, Nasopharyngitis, Pyrexia
Clinical narrative: This is a verbatim narrative as reported on website, accessed on 28 July 2011. According to the website these reports were from FDA VAERS. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. "FLUMIST problem was reported on Dec 26, 2007. Female patient, child 2.6 years of age, was vaccinated with FLUMIST on Dec 26, 2007. "A cold started one day after the vaccine was given. It turned into a fever and so forth it. It has been a roller coaster ride since then. She has been falling sick a number of times after that. (Fever/ear infections probably due to school). But associated with these fevers are cough and cold. The cough stays on for a long time and does not go away. First time it stayed for 7-10 days and now it has been almost a week. Pediatrician now put her on steroids for lungs (SYMBICORT. XOPENEX) and today diagnosed it as asthma. My daughter never had asthma before and she never for this cough before even in the last winter. The FLUMIST was given on Oct 8 but at that time my daughter was not diagnosed with asthma. One of the warnings on FLUMIST handout is to avoid giving it to kids with asthma. My daughter also has eczema and food allergies. I regret getting FLUMIST now with all these warnings abt asthma and 24 months/(she was 5 months over but the warning says increased risk of wheezing for kids <24 mo) and feel that this coughing might be due to that.".."food allergies, eczema." Patient recovered."
Age: 42.0
Sex: M
Vaccine: FLUN3
Symptoms: Chills, Dysphagia, Erythema, Facial pain, Headache
Clinical narrative: This is a verbatim narrative as reported on web site, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. "FLUMIST problem was reported on Dec 26, 2007. Male patient, 42 years of age, was vaccinated with FLUMIST on Dec 05, 2007. "Pain in left side of head, hard to swallow, fever (99.0-101.9), chills, night sweats, lymphadenopathy, facial pain (left temple), L EOC erythemic, increased neutrophils." None. None. Patient recovered."
Age: 42.0
Sex: M
Vaccine: FLUN3
Symptoms: Lymphadenopathy, Neutrophil count increased, Night sweats, Oral candidiasis, Oral herpes
Clinical narrative: This is a verbatim narrative as reported on web site, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. "FLUMIST problem was reported on Dec 26, 2007. Male patient, 42 years of age, was vaccinated with FLUMIST on Dec 05, 2007. "Pain in left side of head, hard to swallow, fever (99.0-101.9), chills, night sweats, lymphadenopathy, facial pain (left temple), L EOC erythemic, increased neutrophils." None. None. Patient recovered."
Age: 19.0
Sex: M
Vaccine: FLUN3
Symptoms: Acute disseminated encephalomyelitis, Borrelia test positive, CSF glucose normal, CSF lymphocyte count abnormal, CSF monocyte count increased
Clinical narrative: THIS IS A VERBATIM NARRATIVE AS REPORTED TO THE FDA VAERS: "Patient admitted for Acute disseminated encephalomyelitis. 1/29/08 Case closed w/medical records that accompanied report which revealed that patient experienced sore throat, congestion and persistent cough when seen 10/8/07. Treated symptomatically and improved initially. Returned to clinic on 10/16/07 w/urticarial rash thought to be caused by fabric softener and resolved with change. Then received multiple vax on 10/16/07. Returned to clinic 10/19/07 w/worsening cough, fever, sore throat and nasal discharge. Tx symptomatically and improved. On 10/26/07 patient had HA, neck stiffness, slurred speech, confusion, collapsed, was stuporous, incontinent of urine and falling asleep on his feet. Taken to ER and transferred to higher level of care. Temp in ER 103.2. Had LP in ER which showed CSF WBC 2240 w/82% polys. Admitted 10/26-11/5/2007 in ICU. Was stiff, unresponsive to stimuli, wringing his hands and shaking. Tx w/IV antibiotics, antivirals and steroids and placed in isolation. ID and neuro consults done. Gradually improved and was d/c to home w/ID and Neuro outpatient f/u. ID outpatient vs of 11/20 revealed patient quite weak w/mild stiff neck, numbness of hands, weak grip, memory and concentration problems. Neuro outpatient vs of 11/21 revealed patient continued to improve but concerned about cognition function. Referred for neuropsych and cognitive rehab. As of 11/30, had weakness of bilateral extremities, more in legs, weak hand grasp, decreased sensation in fingers, easy fatigue and some difficulty w/memory and concentration. FINAL DX: ADEM."
Age: 19.0
Sex: M
Vaccine: FLUN3
Symptoms: CSF neutrophil count increased, CSF protein normal, CSF virus no organisms observed, CSF white blood cell count increased, Cerebral small vessel ischaemic disease
Clinical narrative: THIS IS A VERBATIM NARRATIVE AS REPORTED TO THE FDA VAERS: "Patient admitted for Acute disseminated encephalomyelitis. 1/29/08 Case closed w/medical records that accompanied report which revealed that patient experienced sore throat, congestion and persistent cough when seen 10/8/07. Treated symptomatically and improved initially. Returned to clinic on 10/16/07 w/urticarial rash thought to be caused by fabric softener and resolved with change. Then received multiple vax on 10/16/07. Returned to clinic 10/19/07 w/worsening cough, fever, sore throat and nasal discharge. Tx symptomatically and improved. On 10/26/07 patient had HA, neck stiffness, slurred speech, confusion, collapsed, was stuporous, incontinent of urine and falling asleep on his feet. Taken to ER and transferred to higher level of care. Temp in ER 103.2. Had LP in ER which showed CSF WBC 2240 w/82% polys. Admitted 10/26-11/5/2007 in ICU. Was stiff, unresponsive to stimuli, wringing his hands and shaking. Tx w/IV antibiotics, antivirals and steroids and placed in isolation. ID and neuro consults done. Gradually improved and was d/c to home w/ID and Neuro outpatient f/u. ID outpatient vs of 11/20 revealed patient quite weak w/mild stiff neck, numbness of hands, weak grip, memory and concentration problems. Neuro outpatient vs of 11/21 revealed patient continued to improve but concerned about cognition function. Referred for neuropsych and cognitive rehab. As of 11/30, had weakness of bilateral extremities, more in legs, weak hand grasp, decreased sensation in fingers, easy fatigue and some difficulty w/memory and concentration. FINAL DX: ADEM."
Age: 19.0
Sex: M
Vaccine: FLUN3
Symptoms: Cognitive disorder, Computerised tomogram abnormal, Computerised tomogram head, Condition aggravated, Confusional state
Clinical narrative: THIS IS A VERBATIM NARRATIVE AS REPORTED TO THE FDA VAERS: "Patient admitted for Acute disseminated encephalomyelitis. 1/29/08 Case closed w/medical records that accompanied report which revealed that patient experienced sore throat, congestion and persistent cough when seen 10/8/07. Treated symptomatically and improved initially. Returned to clinic on 10/16/07 w/urticarial rash thought to be caused by fabric softener and resolved with change. Then received multiple vax on 10/16/07. Returned to clinic 10/19/07 w/worsening cough, fever, sore throat and nasal discharge. Tx symptomatically and improved. On 10/26/07 patient had HA, neck stiffness, slurred speech, confusion, collapsed, was stuporous, incontinent of urine and falling asleep on his feet. Taken to ER and transferred to higher level of care. Temp in ER 103.2. Had LP in ER which showed CSF WBC 2240 w/82% polys. Admitted 10/26-11/5/2007 in ICU. Was stiff, unresponsive to stimuli, wringing his hands and shaking. Tx w/IV antibiotics, antivirals and steroids and placed in isolation. ID and neuro consults done. Gradually improved and was d/c to home w/ID and Neuro outpatient f/u. ID outpatient vs of 11/20 revealed patient quite weak w/mild stiff neck, numbness of hands, weak grip, memory and concentration problems. Neuro outpatient vs of 11/21 revealed patient continued to improve but concerned about cognition function. Referred for neuropsych and cognitive rehab. As of 11/30, had weakness of bilateral extremities, more in legs, weak hand grasp, decreased sensation in fingers, easy fatigue and some difficulty w/memory and concentration. FINAL DX: ADEM."
Age: 19.0
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Disturbance in attention, Dysarthria, Dyskinesia, Enterovirus test negative
Clinical narrative: THIS IS A VERBATIM NARRATIVE AS REPORTED TO THE FDA VAERS: "Patient admitted for Acute disseminated encephalomyelitis. 1/29/08 Case closed w/medical records that accompanied report which revealed that patient experienced sore throat, congestion and persistent cough when seen 10/8/07. Treated symptomatically and improved initially. Returned to clinic on 10/16/07 w/urticarial rash thought to be caused by fabric softener and resolved with change. Then received multiple vax on 10/16/07. Returned to clinic 10/19/07 w/worsening cough, fever, sore throat and nasal discharge. Tx symptomatically and improved. On 10/26/07 patient had HA, neck stiffness, slurred speech, confusion, collapsed, was stuporous, incontinent of urine and falling asleep on his feet. Taken to ER and transferred to higher level of care. Temp in ER 103.2. Had LP in ER which showed CSF WBC 2240 w/82% polys. Admitted 10/26-11/5/2007 in ICU. Was stiff, unresponsive to stimuli, wringing his hands and shaking. Tx w/IV antibiotics, antivirals and steroids and placed in isolation. ID and neuro consults done. Gradually improved and was d/c to home w/ID and Neuro outpatient f/u. ID outpatient vs of 11/20 revealed patient quite weak w/mild stiff neck, numbness of hands, weak grip, memory and concentration problems. Neuro outpatient vs of 11/21 revealed patient continued to improve but concerned about cognition function. Referred for neuropsych and cognitive rehab. As of 11/30, had weakness of bilateral extremities, more in legs, weak hand grasp, decreased sensation in fingers, easy fatigue and some difficulty w/memory and concentration. FINAL DX: ADEM."
Age: 19.0
Sex: M
Vaccine: FLUN3
Symptoms: Fatigue, Full blood count normal, Grip strength decreased, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: THIS IS A VERBATIM NARRATIVE AS REPORTED TO THE FDA VAERS: "Patient admitted for Acute disseminated encephalomyelitis. 1/29/08 Case closed w/medical records that accompanied report which revealed that patient experienced sore throat, congestion and persistent cough when seen 10/8/07. Treated symptomatically and improved initially. Returned to clinic on 10/16/07 w/urticarial rash thought to be caused by fabric softener and resolved with change. Then received multiple vax on 10/16/07. Returned to clinic 10/19/07 w/worsening cough, fever, sore throat and nasal discharge. Tx symptomatically and improved. On 10/26/07 patient had HA, neck stiffness, slurred speech, confusion, collapsed, was stuporous, incontinent of urine and falling asleep on his feet. Taken to ER and transferred to higher level of care. Temp in ER 103.2. Had LP in ER which showed CSF WBC 2240 w/82% polys. Admitted 10/26-11/5/2007 in ICU. Was stiff, unresponsive to stimuli, wringing his hands and shaking. Tx w/IV antibiotics, antivirals and steroids and placed in isolation. ID and neuro consults done. Gradually improved and was d/c to home w/ID and Neuro outpatient f/u. ID outpatient vs of 11/20 revealed patient quite weak w/mild stiff neck, numbness of hands, weak grip, memory and concentration problems. Neuro outpatient vs of 11/21 revealed patient continued to improve but concerned about cognition function. Referred for neuropsych and cognitive rehab. As of 11/30, had weakness of bilateral extremities, more in legs, weak hand grasp, decreased sensation in fingers, easy fatigue and some difficulty w/memory and concentration. FINAL DX: ADEM."
Age: 19.0
Sex: M
Vaccine: FLUN3
Symptoms: Headache, Herpes simplex serology negative, Hypoaesthesia, Intensive care, Memory impairment
Clinical narrative: THIS IS A VERBATIM NARRATIVE AS REPORTED TO THE FDA VAERS: "Patient admitted for Acute disseminated encephalomyelitis. 1/29/08 Case closed w/medical records that accompanied report which revealed that patient experienced sore throat, congestion and persistent cough when seen 10/8/07. Treated symptomatically and improved initially. Returned to clinic on 10/16/07 w/urticarial rash thought to be caused by fabric softener and resolved with change. Then received multiple vax on 10/16/07. Returned to clinic 10/19/07 w/worsening cough, fever, sore throat and nasal discharge. Tx symptomatically and improved. On 10/26/07 patient had HA, neck stiffness, slurred speech, confusion, collapsed, was stuporous, incontinent of urine and falling asleep on his feet. Taken to ER and transferred to higher level of care. Temp in ER 103.2. Had LP in ER which showed CSF WBC 2240 w/82% polys. Admitted 10/26-11/5/2007 in ICU. Was stiff, unresponsive to stimuli, wringing his hands and shaking. Tx w/IV antibiotics, antivirals and steroids and placed in isolation. ID and neuro consults done. Gradually improved and was d/c to home w/ID and Neuro outpatient f/u. ID outpatient vs of 11/20 revealed patient quite weak w/mild stiff neck, numbness of hands, weak grip, memory and concentration problems. Neuro outpatient vs of 11/21 revealed patient continued to improve but concerned about cognition function. Referred for neuropsych and cognitive rehab. As of 11/30, had weakness of bilateral extremities, more in legs, weak hand grasp, decreased sensation in fingers, easy fatigue and some difficulty w/memory and concentration. FINAL DX: ADEM."
Age: 19.0
Sex: M
Vaccine: FLUN3
Symptoms: Mental impairment, Muscular weakness, Musculoskeletal stiffness, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: THIS IS A VERBATIM NARRATIVE AS REPORTED TO THE FDA VAERS: "Patient admitted for Acute disseminated encephalomyelitis. 1/29/08 Case closed w/medical records that accompanied report which revealed that patient experienced sore throat, congestion and persistent cough when seen 10/8/07. Treated symptomatically and improved initially. Returned to clinic on 10/16/07 w/urticarial rash thought to be caused by fabric softener and resolved with change. Then received multiple vax on 10/16/07. Returned to clinic 10/19/07 w/worsening cough, fever, sore throat and nasal discharge. Tx symptomatically and improved. On 10/26/07 patient had HA, neck stiffness, slurred speech, confusion, collapsed, was stuporous, incontinent of urine and falling asleep on his feet. Taken to ER and transferred to higher level of care. Temp in ER 103.2. Had LP in ER which showed CSF WBC 2240 w/82% polys. Admitted 10/26-11/5/2007 in ICU. Was stiff, unresponsive to stimuli, wringing his hands and shaking. Tx w/IV antibiotics, antivirals and steroids and placed in isolation. ID and neuro consults done. Gradually improved and was d/c to home w/ID and Neuro outpatient f/u. ID outpatient vs of 11/20 revealed patient quite weak w/mild stiff neck, numbness of hands, weak grip, memory and concentration problems. Neuro outpatient vs of 11/21 revealed patient continued to improve but concerned about cognition function. Referred for neuropsych and cognitive rehab. As of 11/30, had weakness of bilateral extremities, more in legs, weak hand grasp, decreased sensation in fingers, easy fatigue and some difficulty w/memory and concentration. FINAL DX: ADEM."
Age: 19.0
Sex: M
Vaccine: FLUN3
Symptoms: Oropharyngeal pain, Polymerase chain reaction, Pyrexia, Red blood cell count decreased, Red blood cells CSF positive
Clinical narrative: THIS IS A VERBATIM NARRATIVE AS REPORTED TO THE FDA VAERS: "Patient admitted for Acute disseminated encephalomyelitis. 1/29/08 Case closed w/medical records that accompanied report which revealed that patient experienced sore throat, congestion and persistent cough when seen 10/8/07. Treated symptomatically and improved initially. Returned to clinic on 10/16/07 w/urticarial rash thought to be caused by fabric softener and resolved with change. Then received multiple vax on 10/16/07. Returned to clinic 10/19/07 w/worsening cough, fever, sore throat and nasal discharge. Tx symptomatically and improved. On 10/26/07 patient had HA, neck stiffness, slurred speech, confusion, collapsed, was stuporous, incontinent of urine and falling asleep on his feet. Taken to ER and transferred to higher level of care. Temp in ER 103.2. Had LP in ER which showed CSF WBC 2240 w/82% polys. Admitted 10/26-11/5/2007 in ICU. Was stiff, unresponsive to stimuli, wringing his hands and shaking. Tx w/IV antibiotics, antivirals and steroids and placed in isolation. ID and neuro consults done. Gradually improved and was d/c to home w/ID and Neuro outpatient f/u. ID outpatient vs of 11/20 revealed patient quite weak w/mild stiff neck, numbness of hands, weak grip, memory and concentration problems. Neuro outpatient vs of 11/21 revealed patient continued to improve but concerned about cognition function. Referred for neuropsych and cognitive rehab. As of 11/30, had weakness of bilateral extremities, more in legs, weak hand grasp, decreased sensation in fingers, easy fatigue and some difficulty w/memory and concentration. FINAL DX: ADEM."
Age: 19.0
Sex: M
Vaccine: FLUN3
Symptoms: Respiratory tract congestion, Rhinorrhoea, Sensory loss, Sinus disorder, Somnolence
Clinical narrative: THIS IS A VERBATIM NARRATIVE AS REPORTED TO THE FDA VAERS: "Patient admitted for Acute disseminated encephalomyelitis. 1/29/08 Case closed w/medical records that accompanied report which revealed that patient experienced sore throat, congestion and persistent cough when seen 10/8/07. Treated symptomatically and improved initially. Returned to clinic on 10/16/07 w/urticarial rash thought to be caused by fabric softener and resolved with change. Then received multiple vax on 10/16/07. Returned to clinic 10/19/07 w/worsening cough, fever, sore throat and nasal discharge. Tx symptomatically and improved. On 10/26/07 patient had HA, neck stiffness, slurred speech, confusion, collapsed, was stuporous, incontinent of urine and falling asleep on his feet. Taken to ER and transferred to higher level of care. Temp in ER 103.2. Had LP in ER which showed CSF WBC 2240 w/82% polys. Admitted 10/26-11/5/2007 in ICU. Was stiff, unresponsive to stimuli, wringing his hands and shaking. Tx w/IV antibiotics, antivirals and steroids and placed in isolation. ID and neuro consults done. Gradually improved and was d/c to home w/ID and Neuro outpatient f/u. ID outpatient vs of 11/20 revealed patient quite weak w/mild stiff neck, numbness of hands, weak grip, memory and concentration problems. Neuro outpatient vs of 11/21 revealed patient continued to improve but concerned about cognition function. Referred for neuropsych and cognitive rehab. As of 11/30, had weakness of bilateral extremities, more in legs, weak hand grasp, decreased sensation in fingers, easy fatigue and some difficulty w/memory and concentration. FINAL DX: ADEM."
Age: 19.0
Sex: M
Vaccine: FLUN3
Symptoms: Stupor, Syncope, Tremor, Unresponsive to stimuli, Urinary incontinence
Clinical narrative: THIS IS A VERBATIM NARRATIVE AS REPORTED TO THE FDA VAERS: "Patient admitted for Acute disseminated encephalomyelitis. 1/29/08 Case closed w/medical records that accompanied report which revealed that patient experienced sore throat, congestion and persistent cough when seen 10/8/07. Treated symptomatically and improved initially. Returned to clinic on 10/16/07 w/urticarial rash thought to be caused by fabric softener and resolved with change. Then received multiple vax on 10/16/07. Returned to clinic 10/19/07 w/worsening cough, fever, sore throat and nasal discharge. Tx symptomatically and improved. On 10/26/07 patient had HA, neck stiffness, slurred speech, confusion, collapsed, was stuporous, incontinent of urine and falling asleep on his feet. Taken to ER and transferred to higher level of care. Temp in ER 103.2. Had LP in ER which showed CSF WBC 2240 w/82% polys. Admitted 10/26-11/5/2007 in ICU. Was stiff, unresponsive to stimuli, wringing his hands and shaking. Tx w/IV antibiotics, antivirals and steroids and placed in isolation. ID and neuro consults done. Gradually improved and was d/c to home w/ID and Neuro outpatient f/u. ID outpatient vs of 11/20 revealed patient quite weak w/mild stiff neck, numbness of hands, weak grip, memory and concentration problems. Neuro outpatient vs of 11/21 revealed patient continued to improve but concerned about cognition function. Referred for neuropsych and cognitive rehab. As of 11/30, had weakness of bilateral extremities, more in legs, weak hand grasp, decreased sensation in fingers, easy fatigue and some difficulty w/memory and concentration. FINAL DX: ADEM."
Age: 19.0
Sex: M
Vaccine: FLUN3
Symptoms: Varicella virus test negative, White blood cell count normal
Clinical narrative: THIS IS A VERBATIM NARRATIVE AS REPORTED TO THE FDA VAERS: "Patient admitted for Acute disseminated encephalomyelitis. 1/29/08 Case closed w/medical records that accompanied report which revealed that patient experienced sore throat, congestion and persistent cough when seen 10/8/07. Treated symptomatically and improved initially. Returned to clinic on 10/16/07 w/urticarial rash thought to be caused by fabric softener and resolved with change. Then received multiple vax on 10/16/07. Returned to clinic 10/19/07 w/worsening cough, fever, sore throat and nasal discharge. Tx symptomatically and improved. On 10/26/07 patient had HA, neck stiffness, slurred speech, confusion, collapsed, was stuporous, incontinent of urine and falling asleep on his feet. Taken to ER and transferred to higher level of care. Temp in ER 103.2. Had LP in ER which showed CSF WBC 2240 w/82% polys. Admitted 10/26-11/5/2007 in ICU. Was stiff, unresponsive to stimuli, wringing his hands and shaking. Tx w/IV antibiotics, antivirals and steroids and placed in isolation. ID and neuro consults done. Gradually improved and was d/c to home w/ID and Neuro outpatient f/u. ID outpatient vs of 11/20 revealed patient quite weak w/mild stiff neck, numbness of hands, weak grip, memory and concentration problems. Neuro outpatient vs of 11/21 revealed patient continued to improve but concerned about cognition function. Referred for neuropsych and cognitive rehab. As of 11/30, had weakness of bilateral extremities, more in legs, weak hand grasp, decreased sensation in fingers, easy fatigue and some difficulty w/memory and concentration. FINAL DX: ADEM."
Sex: M
Vaccine: FLUN3
Symptoms: Acute disseminated encephalomyelitis, Areflexia, Asthma, Attention deficit/hyperactivity disorder, Brain injury
Clinical narrative: A serious spontaneous report of acute disseminated encephalomyelitis, attention deficit/hyperactivity disorder, post-traumatic stress disorder and non-serious events of pneumonia, ear infection and asthma have been received from a non-health professional through the Vaccine Adverse Event Reporting System (VAERS) concerning a child between the age of 6-17 years old subsequent to FLUMIST. The patient's past medical history and concomitant medications were not reported. On an unknown date, the patient received FLUMIST. The patient had vomiting, fever (103-104), lethargy, cough, anorexia (lost 14 pounds) for more than two and a half weeks. He was diagnosed with an ear infection and pneumonia with treatment that included amoxicillin and azithromycin. The patient was hospitalized on 07-Feb-2008 when he developed seizures with mask-like faces, tremors, rigidity, sweating, facial flushing and a decreased gag reflex. He was placed in intensive care and a nasogastric tube was placed and was treated with azithromycin, five days of pulse therapy with prednisone and high dose dexamethasone. He was discharged from the hospital on 19-Feb-2008. On later follow-up in 21-Jan-2010, a parent reported their son continues to receive occupational therapy and as a result of his brain injury has attention deficit/hyperactivity disorder, post-traumatic stress disorder and asthma. He continues to take medication and is under the care of a psychiatrist. The parent stated that they are in the process of neuropsy and neuroeducational testing to measure potential damage due to encephalopathy. The outcome of the ear infection and pneumonia were not reported and the remaining events were ongoing.
Sex: M
Vaccine: FLUN3
Symptoms: Convulsion, Cough, Decreased appetite, Ear infection, Flushing
Clinical narrative: A serious spontaneous report of acute disseminated encephalomyelitis, attention deficit/hyperactivity disorder, post-traumatic stress disorder and non-serious events of pneumonia, ear infection and asthma have been received from a non-health professional through the Vaccine Adverse Event Reporting System (VAERS) concerning a child between the age of 6-17 years old subsequent to FLUMIST. The patient's past medical history and concomitant medications were not reported. On an unknown date, the patient received FLUMIST. The patient had vomiting, fever (103-104), lethargy, cough, anorexia (lost 14 pounds) for more than two and a half weeks. He was diagnosed with an ear infection and pneumonia with treatment that included amoxicillin and azithromycin. The patient was hospitalized on 07-Feb-2008 when he developed seizures with mask-like faces, tremors, rigidity, sweating, facial flushing and a decreased gag reflex. He was placed in intensive care and a nasogastric tube was placed and was treated with azithromycin, five days of pulse therapy with prednisone and high dose dexamethasone. He was discharged from the hospital on 19-Feb-2008. On later follow-up in 21-Jan-2010, a parent reported their son continues to receive occupational therapy and as a result of his brain injury has attention deficit/hyperactivity disorder, post-traumatic stress disorder and asthma. He continues to take medication and is under the care of a psychiatrist. The parent stated that they are in the process of neuropsy and neuroeducational testing to measure potential damage due to encephalopathy. The outcome of the ear infection and pneumonia were not reported and the remaining events were ongoing.
Sex: M
Vaccine: FLUN3
Symptoms: Gastrointestinal tube insertion, Hyperhidrosis, Intensive care, Lethargy, Masked facies
Clinical narrative: A serious spontaneous report of acute disseminated encephalomyelitis, attention deficit/hyperactivity disorder, post-traumatic stress disorder and non-serious events of pneumonia, ear infection and asthma have been received from a non-health professional through the Vaccine Adverse Event Reporting System (VAERS) concerning a child between the age of 6-17 years old subsequent to FLUMIST. The patient's past medical history and concomitant medications were not reported. On an unknown date, the patient received FLUMIST. The patient had vomiting, fever (103-104), lethargy, cough, anorexia (lost 14 pounds) for more than two and a half weeks. He was diagnosed with an ear infection and pneumonia with treatment that included amoxicillin and azithromycin. The patient was hospitalized on 07-Feb-2008 when he developed seizures with mask-like faces, tremors, rigidity, sweating, facial flushing and a decreased gag reflex. He was placed in intensive care and a nasogastric tube was placed and was treated with azithromycin, five days of pulse therapy with prednisone and high dose dexamethasone. He was discharged from the hospital on 19-Feb-2008. On later follow-up in 21-Jan-2010, a parent reported their son continues to receive occupational therapy and as a result of his brain injury has attention deficit/hyperactivity disorder, post-traumatic stress disorder and asthma. He continues to take medication and is under the care of a psychiatrist. The parent stated that they are in the process of neuropsy and neuroeducational testing to measure potential damage due to encephalopathy. The outcome of the ear infection and pneumonia were not reported and the remaining events were ongoing.
Sex: M
Vaccine: FLUN3
Symptoms: Muscle rigidity, Pneumonia, Post-traumatic stress disorder, Pyrexia, Tremor
Clinical narrative: A serious spontaneous report of acute disseminated encephalomyelitis, attention deficit/hyperactivity disorder, post-traumatic stress disorder and non-serious events of pneumonia, ear infection and asthma have been received from a non-health professional through the Vaccine Adverse Event Reporting System (VAERS) concerning a child between the age of 6-17 years old subsequent to FLUMIST. The patient's past medical history and concomitant medications were not reported. On an unknown date, the patient received FLUMIST. The patient had vomiting, fever (103-104), lethargy, cough, anorexia (lost 14 pounds) for more than two and a half weeks. He was diagnosed with an ear infection and pneumonia with treatment that included amoxicillin and azithromycin. The patient was hospitalized on 07-Feb-2008 when he developed seizures with mask-like faces, tremors, rigidity, sweating, facial flushing and a decreased gag reflex. He was placed in intensive care and a nasogastric tube was placed and was treated with azithromycin, five days of pulse therapy with prednisone and high dose dexamethasone. He was discharged from the hospital on 19-Feb-2008. On later follow-up in 21-Jan-2010, a parent reported their son continues to receive occupational therapy and as a result of his brain injury has attention deficit/hyperactivity disorder, post-traumatic stress disorder and asthma. He continues to take medication and is under the care of a psychiatrist. The parent stated that they are in the process of neuropsy and neuroeducational testing to measure potential damage due to encephalopathy. The outcome of the ear infection and pneumonia were not reported and the remaining events were ongoing.
Sex: M
Vaccine: FLUN3
Symptoms: Vomiting, Weight decreased
Clinical narrative: A serious spontaneous report of acute disseminated encephalomyelitis, attention deficit/hyperactivity disorder, post-traumatic stress disorder and non-serious events of pneumonia, ear infection and asthma have been received from a non-health professional through the Vaccine Adverse Event Reporting System (VAERS) concerning a child between the age of 6-17 years old subsequent to FLUMIST. The patient's past medical history and concomitant medications were not reported. On an unknown date, the patient received FLUMIST. The patient had vomiting, fever (103-104), lethargy, cough, anorexia (lost 14 pounds) for more than two and a half weeks. He was diagnosed with an ear infection and pneumonia with treatment that included amoxicillin and azithromycin. The patient was hospitalized on 07-Feb-2008 when he developed seizures with mask-like faces, tremors, rigidity, sweating, facial flushing and a decreased gag reflex. He was placed in intensive care and a nasogastric tube was placed and was treated with azithromycin, five days of pulse therapy with prednisone and high dose dexamethasone. He was discharged from the hospital on 19-Feb-2008. On later follow-up in 21-Jan-2010, a parent reported their son continues to receive occupational therapy and as a result of his brain injury has attention deficit/hyperactivity disorder, post-traumatic stress disorder and asthma. He continues to take medication and is under the care of a psychiatrist. The parent stated that they are in the process of neuropsy and neuroeducational testing to measure potential damage due to encephalopathy. The outcome of the ear infection and pneumonia were not reported and the remaining events were ongoing.
Age: 14.0
Sex: F
Vaccine: FLUN3
Symptoms: Activities of daily living impaired, Dizziness, Dry throat, Malaise, Nausea
Clinical narrative: "This is a verbatim narrative as reported to the FDA VAERS: "On the way home from the doctors office she complained of feeling nausea. We thought it was the heat along with being in the car as she is susceptible [sic] to migraine headaches, or that she may have been hungry, because she hadn't eaten much in the morning. She had a little something to eat, came home and went to sleep. Woke up in the evening had a little dinner did some homework and went back to bed. All this time complaining of not feeling well. When she woke the next day and tried to get ready for school she felt dizzy, and right before we were to leave to take her to school, she vomited [sic]. She stayed home form school not feeling well throughout the day. Having dry heaves, afraid to eat or drink much. Also complaining of body aches, aches, dizzy, a bit of dry/sore throat, and having a slight fever."
Age: 14.0
Sex: F
Vaccine: FLUN3
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Retching, Vomiting
Clinical narrative: "This is a verbatim narrative as reported to the FDA VAERS: "On the way home from the doctors office she complained of feeling nausea. We thought it was the heat along with being in the car as she is susceptible [sic] to migraine headaches, or that she may have been hungry, because she hadn't eaten much in the morning. She had a little something to eat, came home and went to sleep. Woke up in the evening had a little dinner did some homework and went back to bed. All this time complaining of not feeling well. When she woke the next day and tried to get ready for school she felt dizzy, and right before we were to leave to take her to school, she vomited [sic]. She stayed home form school not feeling well throughout the day. Having dry heaves, afraid to eat or drink much. Also complaining of body aches, aches, dizzy, a bit of dry/sore throat, and having a slight fever."
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Anion gap increased, Blood glucose increased, Blood immunoglobulin A normal, Blood ketone body, Blood potassium decreased
Clinical narrative: This is a verbatim narrative as reported to the FDA VAERS: "Onset type I diabetes mellitus 1/7/09. Reviewed hospital records for 10/18-10/22/2008. FINAL DX: new onset type 1 diabetes mellitus; DKA Records reveal patient experienced polyuria, polydipsia, nocturia & weight loss over 6 wk period. Admitted PICU on insulin drip for DKA. Stabilized on sq insulin & d/c to home w/continued diabetes education & management in clinic."
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Carbon dioxide decreased, Diabetic ketoacidosis, Glucose urine present, Glycosylated haemoglobin increased, Intensive care
Clinical narrative: This is a verbatim narrative as reported to the FDA VAERS: "Onset type I diabetes mellitus 1/7/09. Reviewed hospital records for 10/18-10/22/2008. FINAL DX: new onset type 1 diabetes mellitus; DKA Records reveal patient experienced polyuria, polydipsia, nocturia & weight loss over 6 wk period. Admitted PICU on insulin drip for DKA. Stabilized on sq insulin & d/c to home w/continued diabetes education & management in clinic."