chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Local reaction, Pruritus
Clinical narrative: Last PM mom noted swelling at injection site and pt felt feverish. 9 year old female seen yesterday for well child check. Received multiple vaccs, to include varicella-2 and Hep A-2 in right arm. Mom noted swelling at site this morning and then noted blisters at center. Child complains of significant pruritis, but not pain. Has been afebrile and otherwise well. Has had no hx of reaction to immunizations before.   O: well demarcated area of erythema and swelling to lateral right arm. Two areas centrally of blistering, one small (1 cm) and one larger approx. 2.3 cm. No streaking, minimal warmth, no axillary LAD.  A/P:contact dermatitis, local reaction 1. reassured parent regarding local reaction, not uncommon when receiving booster of a vaccine. Use benadryl and cool compresses as needed for comfort. RTC or ER asap for fever, swelling, extension of redness, streaking up the arm or pain. 2. contact dermatitis, unsure etiology (cleaning agent, component of vaccine, bandaid). Apply hydrocortisone to area bid for 1 week. 3. F/U as needed. 4. VAERS report filed.  MD
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Blood creatinine increased, Blood urea increased, Chest X-ray abnormal, Chills, Computerised tomogram abnormal
Clinical narrative: ON 8-12-08ON PT C/O S.O.B.FEVER CHILLS AND COUGH CXR:BILATERAL INFLITRATE. ROCEPHIN 1 GRAM, AVELOX 400MG 1 QD #10 DAYS, Z-PAK #1, VALTREX 1 GR TID #30. ON 08-12-08 HOMEHEALTH IV HYDRATION 500ML BOLUS OF N.S. AND 2 GRAM ROCEPHIN IV.8-14-08 INCREASILY S.O.B. STILL C/O CHILLS, AND FEVER. REPEAT CX WORSENING BILATERAL PNEUMONIA/CT SHOWED INFILTRATES WITH EFFUSION. LAB SHOWED BUN OF 74, CREATININE 3.1, HEMOGLOBIN 9.3. HEMATOCRIT 28.2. PATIENT TRANSFERRED TO HOSPITAL. 10/27/08-records received for DOS 8/14-8/21/08-DC DX: Shortness of breath. Respiratory distress. Presented with C/O SOB and pain/numbness in legs. Progressive SOB times 2 weeks and RLE swelling began after flight. Returned 2 weeks prior from foreign travel.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Cough, Dyspnoea, Effusion, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: ON 8-12-08ON PT C/O S.O.B.FEVER CHILLS AND COUGH CXR:BILATERAL INFLITRATE. ROCEPHIN 1 GRAM, AVELOX 400MG 1 QD #10 DAYS, Z-PAK #1, VALTREX 1 GR TID #30. ON 08-12-08 HOMEHEALTH IV HYDRATION 500ML BOLUS OF N.S. AND 2 GRAM ROCEPHIN IV.8-14-08 INCREASILY S.O.B. STILL C/O CHILLS, AND FEVER. REPEAT CX WORSENING BILATERAL PNEUMONIA/CT SHOWED INFILTRATES WITH EFFUSION. LAB SHOWED BUN OF 74, CREATININE 3.1, HEMOGLOBIN 9.3. HEMATOCRIT 28.2. PATIENT TRANSFERRED TO HOSPITAL. 10/27/08-records received for DOS 8/14-8/21/08-DC DX: Shortness of breath. Respiratory distress. Presented with C/O SOB and pain/numbness in legs. Progressive SOB times 2 weeks and RLE swelling began after flight. Returned 2 weeks prior from foreign travel.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Lung infiltration, Pneumonia, Pyrexia
Clinical narrative: ON 8-12-08ON PT C/O S.O.B.FEVER CHILLS AND COUGH CXR:BILATERAL INFLITRATE. ROCEPHIN 1 GRAM, AVELOX 400MG 1 QD #10 DAYS, Z-PAK #1, VALTREX 1 GR TID #30. ON 08-12-08 HOMEHEALTH IV HYDRATION 500ML BOLUS OF N.S. AND 2 GRAM ROCEPHIN IV.8-14-08 INCREASILY S.O.B. STILL C/O CHILLS, AND FEVER. REPEAT CX WORSENING BILATERAL PNEUMONIA/CT SHOWED INFILTRATES WITH EFFUSION. LAB SHOWED BUN OF 74, CREATININE 3.1, HEMOGLOBIN 9.3. HEMATOCRIT 28.2. PATIENT TRANSFERRED TO HOSPITAL. 10/27/08-records received for DOS 8/14-8/21/08-DC DX: Shortness of breath. Respiratory distress. Presented with C/O SOB and pain/numbness in legs. Progressive SOB times 2 weeks and RLE swelling began after flight. Returned 2 weeks prior from foreign travel.
Age: 6.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Hyperhidrosis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Fever of 101 the same night. Sweating, chills. Large red mark on arm, hot to the touch and swollen two days after vaccine.  Put on antibotics...Reaction was to the Pneumonia Vaccine...
Age: 6.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Fever of 101 the same night. Sweating, chills. Large red mark on arm, hot to the touch and swollen two days after vaccine.  Put on antibotics...Reaction was to the Pneumonia Vaccine...
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Skin lesion
Clinical narrative: Shingles Outbreak. Original visit 8/14/08- physician did not diagnose Shingles. Progress of lesions lead patient to revisit 8/18. Shingles verified. Valtrex prescribed. Patient will report on recovery process periodically.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC, RV5
Symptoms: Anaphylactoid reaction, Dyspnoea, Eye swelling, Increased upper airway secretion
Clinical narrative: 20 minutes after vaccines, swelling of eyes, increased secretions, worker breathing. Seen in ED - improved with Epi very rapidly. "Anaphylactoid reaction"  9/2/08 Reviewed hospital medical records of 8/19/08. FINAL DX:acute allergic reaction & anaphylactoid reaction Records reveal patient experienced runny nose, congestion, red eyes & swollen, SOB, grunting, wheezing, rash, facial hives, irritability.  Tx w/steroids, epi & nebs.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Muscle spasms, Trismus
Clinical narrative: Patient received GARDASIL #1 around 2 am.  At 2:20 pm, patient developed dizziness and right leg cramp followed by locked jaw C-1.  Patient remained alert.  Sent to ER - patient received IV turodol and recovered in 5-10 minutes and discharged from ER.  Phone patient at 2 am 8/20 - patient ok.  8/22/2008 ER record received for DOS 8/20/2008 with DX:  Trismus-resolved. Pt presented to ER from PCP office after receiving 1st Gardasil.  Following shot, pt's jaw locked and couldn't open mouth.  Pt c/o 8/10 jaw pain. Toradol given IV.  Full ROM of jaw 40 minutes later. D/c home
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Feeling hot
Clinical narrative: Patient reported that 2 days after getting ADACEL vaccine her face and cheeks felt hot and were beet red.
Age: 13.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Blood urine present, Full blood count, Headache, Lymphadenopathy, Malaise
Clinical narrative: 2 hrs after getting GARDASIL #3 and VARIVAX #2, patient had body aches, headache.  Later that evening, had fever to 102.  Woke 4AM with nausea, vomiting x 2-3.  Nausea, malaise persisted.  Seen in office for evaluation 8/19, was afebrile, mild cervical and inguinal adenopathy.
Age: 13.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Metabolic function test normal, Monocyte percentage increased, Nausea, Neutrophil percentage, Pain
Clinical narrative: 2 hrs after getting GARDASIL #3 and VARIVAX #2, patient had body aches, headache.  Later that evening, had fever to 102.  Woke 4AM with nausea, vomiting x 2-3.  Nausea, malaise persisted.  Seen in office for evaluation 8/19, was afebrile, mild cervical and inguinal adenopathy.
Age: 13.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Pyrexia, Vomiting, White blood cell count normal, White blood cells urine positive
Clinical narrative: 2 hrs after getting GARDASIL #3 and VARIVAX #2, patient had body aches, headache.  Later that evening, had fever to 102.  Woke 4AM with nausea, vomiting x 2-3.  Nausea, malaise persisted.  Seen in office for evaluation 8/19, was afebrile, mild cervical and inguinal adenopathy.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: 5cm x 3cm irregular area of erythema. Mildly tender and warm. Mild edema. No drainage from needle site. All noted at site of varicella vaccine; Recommended cool compresses and Tylenol or Motrin for discomfort.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature, Dizziness, Hypoaesthesia, Nausea, Nervousness
Clinical narrative: Complained of forearm that - PM both left and right; Next day numbness and tingling, shaking and light headedness lasting 3-4 hours. Nausea 48 hours; Temp normal 2D post.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia, Rash
Clinical narrative: Complained of forearm that - PM both left and right; Next day numbness and tingling, shaking and light headedness lasting 3-4 hours. Nausea 48 hours; Temp normal 2D post.
Age: 19.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Computerised tomogram normal, Dizziness, Dyskinesia, Fall, Haematoma
Clinical narrative: As soon as HPV vaccine was given pt's body "jerked out of chair" & fell on floor on L side hitting L supraorbital area.  Hematoma 5cm.  Pt stated she felt dizzy & lost consciousness for a second or two.
Age: 19.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Head injury, Headache, Immediate post-injection reaction, Loss of consciousness, Nausea
Clinical narrative: As soon as HPV vaccine was given pt's body "jerked out of chair" & fell on floor on L side hitting L supraorbital area.  Hematoma 5cm.  Pt stated she felt dizzy & lost consciousness for a second or two.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Complained of red, "itchy" rash at injection site approx 3-4 diameter (fine rash)
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Hypersensitivity, Rash
Clinical narrative: Patient developed an extensive rash. She was seen by Dr. 6/21 and thought to have a contact dermatitis. The rash worsened and patient was seen by an allergist who stated patient had an allergic reaction to one of the vaccines. This is in follow-up to report(s) previously submitted on 9/14/2008. Information has been received from a licensed piratical nurse concerning a 16 year old female with no pertinent medical history and sulfa allergy, CECLOR and seafood allergy who on 18-JUN-2008 was vaccinated intramuscularly with a 0.5 ml first dose of GARDASIL (LOT# 660391/0063X). On the same day, the patient was also vaccinated with a dose of ADACEL, MENACTRA, and HAVRIX. There was no concomitant medication. On 19-JUN-2008 the patient developed blisters that varied in size from a pin point to an eraser. The blisters first appeared under one arm (which arm was unspecified) and then spread over her entire body. Her face was swollen and covered with blisters. The patient was examined by her physician on 21-JUN-2008 and an allergist on 23-JUN-2008. The allergist prescribed prednisone. The patient was recovering. Follow up information was received from the physician who reported that the patient was a female student with no pre-existing allergies, birth defects, or medical conditions who on 18-JUN-08 was vaccinated with a first dose of GARDASIL and a first dose MENACTRA (lot #U2621AA) in her right deltoid. On the same day, the patient was also vaccinated with a first dose of ADACEL (lot #C2938AA) and a first dose of HAVRIX (lot # AHAVB238AA) in her left deltoid. There was no illness at the time of vaccination. On 28-JUN-2008 the patient developed an extensive rash. On 21-JUN-2008 the patient was seen by a physician and was thought to have a contact dermatitis. The rash worsened, the patient was seen by an allergist. The allergist stated that the patient had an allergy reaction to one of the vaccines. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Blister, Swelling face
Clinical narrative: Patient developed an extensive rash. She was seen by Dr. 6/21 and thought to have a contact dermatitis. The rash worsened and patient was seen by an allergist who stated patient had an allergic reaction to one of the vaccines. This is in follow-up to report(s) previously submitted on 9/14/2008. Information has been received from a licensed piratical nurse concerning a 16 year old female with no pertinent medical history and sulfa allergy, CECLOR and seafood allergy who on 18-JUN-2008 was vaccinated intramuscularly with a 0.5 ml first dose of GARDASIL (LOT# 660391/0063X). On the same day, the patient was also vaccinated with a dose of ADACEL, MENACTRA, and HAVRIX. There was no concomitant medication. On 19-JUN-2008 the patient developed blisters that varied in size from a pin point to an eraser. The blisters first appeared under one arm (which arm was unspecified) and then spread over her entire body. Her face was swollen and covered with blisters. The patient was examined by her physician on 21-JUN-2008 and an allergist on 23-JUN-2008. The allergist prescribed prednisone. The patient was recovering. Follow up information was received from the physician who reported that the patient was a female student with no pre-existing allergies, birth defects, or medical conditions who on 18-JUN-08 was vaccinated with a first dose of GARDASIL and a first dose MENACTRA (lot #U2621AA) in her right deltoid. On the same day, the patient was also vaccinated with a first dose of ADACEL (lot #C2938AA) and a first dose of HAVRIX (lot # AHAVB238AA) in her left deltoid. There was no illness at the time of vaccination. On 28-JUN-2008 the patient developed an extensive rash. On 21-JUN-2008 the patient was seen by a physician and was thought to have a contact dermatitis. The rash worsened, the patient was seen by an allergist. The allergist stated that the patient had an allergy reaction to one of the vaccines. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: DTAP, PNC
Symptoms: Erythema, Swelling
Clinical narrative: Slightly swollen and red
Age: 1.2
Sex: F
Vaccine: HIBV, PNC
Symptoms: Full blood count, Haemoglobin normal, Pyrexia, Vomiting, White blood cell count normal
Clinical narrative: High fever to 104.7 and vomiting
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Pain, Pain in extremity, Skin warm, Swelling
Clinical narrative: Woke with arm pain, hot to touch, swollen, red and painful. Child exam by provider - put on antibiotic Augmentin 250/62.5mg 1 BID x 7 days
Age: 65.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: None. Patient received 1 dose of Dtap vaccine instead of Tdap dose.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Left leg swollen, red
Sex: F
Vaccine: MMR
Symptoms: Blood pressure decreased, Disorientation
Clinical narrative: Patient B/P dropped. Patient felt disoriented.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Swollen (L) deltoid, warm to touch. Tx Benadryl.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: One day after DTaP, arm became swollen, red, hot, tender 10x10cm.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Pt states noticed bumps on arm on 8/14/08. On 8/15/08 had hives to arms, face, neck and back. Started having difficulty breathing and went to physician. Was given an injection in left hip along with Xyzal PO. Also taking Benadryl. Advised not to get another Hepatitis B shot.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site papule, Injection site vesicles
Clinical narrative: The day after vaccine was given, child developed approximately 5cm circle of erythema and edema at shot site. Center of circle had scattered papules and vesicles.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Chest X-ray normal, Crying, Electrocardiogram normal, Electroencephalogram normal, Hypotonia
Clinical narrative: Information regarding PREVNAR was received from a physician via GlaxoSmithKline regarding a 2-month-old female patient who experienced hypotonia, pallor and inconsolable crying.  The patient received a dose on 14-Jul-2008.  The patient also received a dose of PEDIARIX (GlaxoSmithKline) on 14-Jul-2008.  Relevant medical history was not provided.  Additional suspect medication included Hib.  There were no concurrent medications.  The patient experienced hypotonia, pallor and inconsolable crying on 14-Jul-2008, fifteen minutes after vaccinations.  This was considered to be a systemic reaction.  The events resolved within about 15 minutes.  The patient was taken to the hospital Emergency Room, and admitted for overnight stay in the hospital.  Diagnostic tests were performed (see test results).  All test results were normal.  It was the physician's opinion that hypotonia, inconsolable crying and pallor were possibly related to administration of PEDIARIX.  The physician questioned a specific lot of PEDIARIX, because she had another patient who had experienced adverse events after receiving the same lot of PEDIARIX.  No additional information was available at the time of this report.  On 14-Jul-2008 test results were: electroencephalogram (results: normal); chest X-ray (results: normal); investigation (results: lab work - normal); and electrocardiogram (results: normal).  RELATED CASE: US-wYE-H05629208 (same source).
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Laboratory test normal, Pallor, Pharmaceutical product complaint
Clinical narrative: Information regarding PREVNAR was received from a physician via GlaxoSmithKline regarding a 2-month-old female patient who experienced hypotonia, pallor and inconsolable crying.  The patient received a dose on 14-Jul-2008.  The patient also received a dose of PEDIARIX (GlaxoSmithKline) on 14-Jul-2008.  Relevant medical history was not provided.  Additional suspect medication included Hib.  There were no concurrent medications.  The patient experienced hypotonia, pallor and inconsolable crying on 14-Jul-2008, fifteen minutes after vaccinations.  This was considered to be a systemic reaction.  The events resolved within about 15 minutes.  The patient was taken to the hospital Emergency Room, and admitted for overnight stay in the hospital.  Diagnostic tests were performed (see test results).  All test results were normal.  It was the physician's opinion that hypotonia, inconsolable crying and pallor were possibly related to administration of PEDIARIX.  The physician questioned a specific lot of PEDIARIX, because she had another patient who had experienced adverse events after receiving the same lot of PEDIARIX.  No additional information was available at the time of this report.  On 14-Jul-2008 test results were: electroencephalogram (results: normal); chest X-ray (results: normal); investigation (results: lab work - normal); and electrocardiogram (results: normal).  RELATED CASE: US-wYE-H05629208 (same source).
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Laboratory test normal, Pallor
Clinical narrative: Information regarding PREVNAR was received from a physician via GlaxoSmithKline regarding a 2-month-old female patient who experienced hypotonia, pallor and inconsolable crying.  The patient received a dose on 14-Jul-2008.  The patient also received a dose of PEDIARIX (GlaxoSmithKline) on 14-Jul-2008.  Relevant medical history was not provided.  Additional suspect medication included Hib.  There were no concurrent medications.  The patient experienced hypotonia, pallor and inconsolable crying on 14-Jul-2008, fifteen minutes after vaccinations.  This was considered to be a systemic reaction.  The events resolved within about 15 minutes.  The patient was taken to the hospital Emergency Room, and admitted for overnight stay in the hospital.  Diagnostic tests were performed (see test results).  All test results were normal.  It was the physician's opinion that hypotonia, inconsolable crying and pallor were possibly related to administration of PEDIARIX.  The physician questioned a specific lot of PEDIARIX, because she had another patient who had experienced adverse events after receiving the same lot of PEDIARIX.  No additional information was available at the time of this report.  On 14-Jul-2008 test results were: electroencephalogram (results: normal); chest X-ray (results: normal); investigation (results: lab work - normal); and electrocardiogram (results: normal).  RELATED CASE: US-wYE-H05629208 (same source).
Age: 9.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Cellulitis, Erythema, Inappropriate schedule of drug administration, Local reaction, Oedema peripheral
Clinical narrative: (L) upper arm localized cellulitis. Red, swollen, tender.
Age: 9.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Tenderness
Clinical narrative: (L) upper arm localized cellulitis. Red, swollen, tender.
Age: 1.4
Sex: F
Vaccine: PNC
Symptoms: Autism, Cognitive disorder, Developmental delay, Psychomotor skills impaired, Speech disorder developmental
Clinical narrative: This case was considered medically important. Information regarding PREVENAR was received from a consumer, the mother of a female patient, who on 24-Jan-2008, at 16 months of age received extra dose (fifth dose) of PREVNAR by mistake. On unspecified dates, the patient experienced developmental delay, possible autism (unable to be evaluated until age three), cognitive delay, delayed speech and delayed walking. On 24-Jan-2008, at 16 months of age, the patient received extra dose (fifth dose) of PREVNAR by mistake. Additionally, the child's mother and grandmother feel the child is experiencing developmental delays due to PREVNAR and report that the patient's hands tremble when she wakes up in the morning now. Additionally, on unspecified dates, the patient experienced cognitive delay, delayed speech and delayed walking and possible autism (unable to be evaluated until age three). The patient is currently receiving (unspecified) therapy for developmental delays. The patient's outcome is unknown. No additional information was available at the time of this report.
Age: 1.4
Sex: F
Vaccine: PNC
Symptoms: Tremor
Clinical narrative: This case was considered medically important. Information regarding PREVENAR was received from a consumer, the mother of a female patient, who on 24-Jan-2008, at 16 months of age received extra dose (fifth dose) of PREVNAR by mistake. On unspecified dates, the patient experienced developmental delay, possible autism (unable to be evaluated until age three), cognitive delay, delayed speech and delayed walking. On 24-Jan-2008, at 16 months of age, the patient received extra dose (fifth dose) of PREVNAR by mistake. Additionally, the child's mother and grandmother feel the child is experiencing developmental delays due to PREVNAR and report that the patient's hands tremble when she wakes up in the morning now. Additionally, on unspecified dates, the patient experienced cognitive delay, delayed speech and delayed walking and possible autism (unable to be evaluated until age three). The patient is currently receiving (unspecified) therapy for developmental delays. The patient's outcome is unknown. No additional information was available at the time of this report.
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Vaccine positive rechallenge
Clinical narrative: Initial report was received 11 August 2008 from another manufacturer who received the report from a health care professional.  A female patient (age not provided) "felt sick and had malaise symptoms for ten months after she [had received a] flu vaccine (manufacturer and lot number not reported) for the first time.  When she was given the flu vaccine the second time she had the same symptoms for six months".  The patients recovery status was not reported.  No further information was provided.
Sex: F
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: Initial report received on 11 August 2008 from another manufacturer, who had received the original report from a health care professional.  Follow-up information was also received on 14 August 2008 via telephone contact with the original reporter who is a health care professional.  A female patient had reported that many years ago she "ended up in the hospital" after vaccination with an unknown flu vaccine.  At that time, the patient's doctor had told her that the event (which was not specified) was due to the albumin binders in the flu vaccine.  The manufacturer of the flu vaccine was unknown.  The date of vaccination, lot number, route and site of administration was also not reported.  The patient's recovery status was not reported, and no other relevant medically significant information was provided.  No further information is expected.
Age: 20.0
Sex: M
Vaccine: SMALL, TYP, TYP
Symptoms: Blood product transfusion, CSF glucose increased, CSF myelin basic protein increased, CSF oligoclonal band absent, CSF protein increased
Clinical narrative: The following information was obtained from the above-referenced literature article received on 14 August 2008.  The author wrote: "A 20-year-old man developed acute disseminated encephalomyelitis after receiving smallpox vaccine and typhoid vaccine (dosages not stated).  He was successfully treated with immune globulin (IVIG).  The man received smallpox vaccine, and 2 days later, received typhoid vaccine.  Twelve days after receiving smallpox vaccine, he developed an ascending , circumferential numbness in his lower extremities that progressed to profound muscle weakness over 24 hours.  He had decreased sensation up to his nipple line, symmetric hyperreflexia with 3-4 beat clonus, and significant lower extremity weakness.  Catheterisation produced 900mL of urine.  Within hours of presentation, he required intubation and, 48 hours after presentation, an MRI revealed multifocal diffuse T2 hyperintensity throughout his brain and spinal cord.  CSF examination revealed 27 leucocytes, 40 erythrocytes, glucose of 80 and protein of 113.  He had an elevated myelin basic protein level (6.0).  Oligoclonal bands were absent.  The man started receiving high-dose methylprednisolone sodium succinate, but remained obtunded and quadriplegic with hyperreflexia.  On day 7 of symptoms, he received a 5% IVIG 2 g/kg infusion over 8 hours followed by steroid taper.  Within 12 hours, he was able to raise his arm and, within 48 hours, he regained spontaneous eye opening.  He was extubated and, 19 days after IVIG therapy, fine motor control had returned to his upper extremities.  However, his recovery plateaued after 2 weeks.  He then received IVIG 150g boluses at weeks 3 and 4, but showed minimal improvement.  By the 4th week, sensory deficits had recovered down to his umbilicus.  He was subsequently transferred to another facility and, at that time, he had good strength and fine motor control of his upper extremities.  He also could move his right lower extremity with gravity, but his left lower extremity remained significantly impaired.  Over the next year, he showed improvement following physical and occupational therapy.  He continued to have detrusor sphincter dyssynergia and required cholinergic receptor antagonists and daily catheterisation."
Age: 20.0
Sex: M
Vaccine: SMALL, TYP, TYP
Symptoms: CSF white blood cell count increased, Catheter placement, Clonus, Depressed level of consciousness, Detrusor sphincter dyssynergia
Clinical narrative: The following information was obtained from the above-referenced literature article received on 14 August 2008.  The author wrote: "A 20-year-old man developed acute disseminated encephalomyelitis after receiving smallpox vaccine and typhoid vaccine (dosages not stated).  He was successfully treated with immune globulin (IVIG).  The man received smallpox vaccine, and 2 days later, received typhoid vaccine.  Twelve days after receiving smallpox vaccine, he developed an ascending , circumferential numbness in his lower extremities that progressed to profound muscle weakness over 24 hours.  He had decreased sensation up to his nipple line, symmetric hyperreflexia with 3-4 beat clonus, and significant lower extremity weakness.  Catheterisation produced 900mL of urine.  Within hours of presentation, he required intubation and, 48 hours after presentation, an MRI revealed multifocal diffuse T2 hyperintensity throughout his brain and spinal cord.  CSF examination revealed 27 leucocytes, 40 erythrocytes, glucose of 80 and protein of 113.  He had an elevated myelin basic protein level (6.0).  Oligoclonal bands were absent.  The man started receiving high-dose methylprednisolone sodium succinate, but remained obtunded and quadriplegic with hyperreflexia.  On day 7 of symptoms, he received a 5% IVIG 2 g/kg infusion over 8 hours followed by steroid taper.  Within 12 hours, he was able to raise his arm and, within 48 hours, he regained spontaneous eye opening.  He was extubated and, 19 days after IVIG therapy, fine motor control had returned to his upper extremities.  However, his recovery plateaued after 2 weeks.  He then received IVIG 150g boluses at weeks 3 and 4, but showed minimal improvement.  By the 4th week, sensory deficits had recovered down to his umbilicus.  He was subsequently transferred to another facility and, at that time, he had good strength and fine motor control of his upper extremities.  He also could move his right lower extremity with gravity, but his left lower extremity remained significantly impaired.  Over the next year, he showed improvement following physical and occupational therapy.  He continued to have detrusor sphincter dyssynergia and required cholinergic receptor antagonists and daily catheterisation."
Age: 20.0
Sex: M
Vaccine: SMALL, TYP, TYP
Symptoms: Endotracheal intubation, Hyperreflexia, Hypoaesthesia, Leukoencephalomyelitis, Muscular weakness
Clinical narrative: The following information was obtained from the above-referenced literature article received on 14 August 2008.  The author wrote: "A 20-year-old man developed acute disseminated encephalomyelitis after receiving smallpox vaccine and typhoid vaccine (dosages not stated).  He was successfully treated with immune globulin (IVIG).  The man received smallpox vaccine, and 2 days later, received typhoid vaccine.  Twelve days after receiving smallpox vaccine, he developed an ascending , circumferential numbness in his lower extremities that progressed to profound muscle weakness over 24 hours.  He had decreased sensation up to his nipple line, symmetric hyperreflexia with 3-4 beat clonus, and significant lower extremity weakness.  Catheterisation produced 900mL of urine.  Within hours of presentation, he required intubation and, 48 hours after presentation, an MRI revealed multifocal diffuse T2 hyperintensity throughout his brain and spinal cord.  CSF examination revealed 27 leucocytes, 40 erythrocytes, glucose of 80 and protein of 113.  He had an elevated myelin basic protein level (6.0).  Oligoclonal bands were absent.  The man started receiving high-dose methylprednisolone sodium succinate, but remained obtunded and quadriplegic with hyperreflexia.  On day 7 of symptoms, he received a 5% IVIG 2 g/kg infusion over 8 hours followed by steroid taper.  Within 12 hours, he was able to raise his arm and, within 48 hours, he regained spontaneous eye opening.  He was extubated and, 19 days after IVIG therapy, fine motor control had returned to his upper extremities.  However, his recovery plateaued after 2 weeks.  He then received IVIG 150g boluses at weeks 3 and 4, but showed minimal improvement.  By the 4th week, sensory deficits had recovered down to his umbilicus.  He was subsequently transferred to another facility and, at that time, he had good strength and fine motor control of his upper extremities.  He also could move his right lower extremity with gravity, but his left lower extremity remained significantly impaired.  Over the next year, he showed improvement following physical and occupational therapy.  He continued to have detrusor sphincter dyssynergia and required cholinergic receptor antagonists and daily catheterisation."
Age: 20.0
Sex: M
Vaccine: SMALL, TYP, TYP
Symptoms: Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain abnormal, Occupational therapy, Physiotherapy, Quadriplegia
Clinical narrative: The following information was obtained from the above-referenced literature article received on 14 August 2008.  The author wrote: "A 20-year-old man developed acute disseminated encephalomyelitis after receiving smallpox vaccine and typhoid vaccine (dosages not stated).  He was successfully treated with immune globulin (IVIG).  The man received smallpox vaccine, and 2 days later, received typhoid vaccine.  Twelve days after receiving smallpox vaccine, he developed an ascending , circumferential numbness in his lower extremities that progressed to profound muscle weakness over 24 hours.  He had decreased sensation up to his nipple line, symmetric hyperreflexia with 3-4 beat clonus, and significant lower extremity weakness.  Catheterisation produced 900mL of urine.  Within hours of presentation, he required intubation and, 48 hours after presentation, an MRI revealed multifocal diffuse T2 hyperintensity throughout his brain and spinal cord.  CSF examination revealed 27 leucocytes, 40 erythrocytes, glucose of 80 and protein of 113.  He had an elevated myelin basic protein level (6.0).  Oligoclonal bands were absent.  The man started receiving high-dose methylprednisolone sodium succinate, but remained obtunded and quadriplegic with hyperreflexia.  On day 7 of symptoms, he received a 5% IVIG 2 g/kg infusion over 8 hours followed by steroid taper.  Within 12 hours, he was able to raise his arm and, within 48 hours, he regained spontaneous eye opening.  He was extubated and, 19 days after IVIG therapy, fine motor control had returned to his upper extremities.  However, his recovery plateaued after 2 weeks.  He then received IVIG 150g boluses at weeks 3 and 4, but showed minimal improvement.  By the 4th week, sensory deficits had recovered down to his umbilicus.  He was subsequently transferred to another facility and, at that time, he had good strength and fine motor control of his upper extremities.  He also could move his right lower extremity with gravity, but his left lower extremity remained significantly impaired.  Over the next year, he showed improvement following physical and occupational therapy.  He continued to have detrusor sphincter dyssynergia and required cholinergic receptor antagonists and daily catheterisation."
Age: 20.0
Sex: M
Vaccine: SMALL, TYP, TYP
Symptoms: Red blood cells CSF positive, Sensory loss
Clinical narrative: The following information was obtained from the above-referenced literature article received on 14 August 2008.  The author wrote: "A 20-year-old man developed acute disseminated encephalomyelitis after receiving smallpox vaccine and typhoid vaccine (dosages not stated).  He was successfully treated with immune globulin (IVIG).  The man received smallpox vaccine, and 2 days later, received typhoid vaccine.  Twelve days after receiving smallpox vaccine, he developed an ascending , circumferential numbness in his lower extremities that progressed to profound muscle weakness over 24 hours.  He had decreased sensation up to his nipple line, symmetric hyperreflexia with 3-4 beat clonus, and significant lower extremity weakness.  Catheterisation produced 900mL of urine.  Within hours of presentation, he required intubation and, 48 hours after presentation, an MRI revealed multifocal diffuse T2 hyperintensity throughout his brain and spinal cord.  CSF examination revealed 27 leucocytes, 40 erythrocytes, glucose of 80 and protein of 113.  He had an elevated myelin basic protein level (6.0).  Oligoclonal bands were absent.  The man started receiving high-dose methylprednisolone sodium succinate, but remained obtunded and quadriplegic with hyperreflexia.  On day 7 of symptoms, he received a 5% IVIG 2 g/kg infusion over 8 hours followed by steroid taper.  Within 12 hours, he was able to raise his arm and, within 48 hours, he regained spontaneous eye opening.  He was extubated and, 19 days after IVIG therapy, fine motor control had returned to his upper extremities.  However, his recovery plateaued after 2 weeks.  He then received IVIG 150g boluses at weeks 3 and 4, but showed minimal improvement.  By the 4th week, sensory deficits had recovered down to his umbilicus.  He was subsequently transferred to another facility and, at that time, he had good strength and fine motor control of his upper extremities.  He also could move his right lower extremity with gravity, but his left lower extremity remained significantly impaired.  Over the next year, he showed improvement following physical and occupational therapy.  He continued to have detrusor sphincter dyssynergia and required cholinergic receptor antagonists and daily catheterisation."
Age: 20.0
Sex: M
Vaccine: SMALL, TYP, TYP
Symptoms: Bacterial culture negative, Blood product transfusion, CSF glucose abnormal, CSF myelin basic protein increased, CSF oligoclonal band absent
Clinical narrative: The following information was obtained from the above-referenced literature article received on 14 August 2008.  The author wrote: "A 20-year-old man developed acute disseminated encephalomyelitis after receiving smallpox vaccine and typhoid vaccine (dosages not stated).  He was successfully treated with immune globulin (IVIG).  The man received smallpox vaccine, and 2 days later, received typhoid vaccine.  Twelve days after receiving smallpox vaccine, he developed an ascending , circumferential numbness in his lower extremities that progressed to profound muscle weakness over 24 hours.  He had decreased sensation up to his nipple line, symmetric hyperreflexia with 3-4 beat clonus, and significant lower extremity weakness.  Catheterisation produced 900mL of urine.  Within hours of presentation, he required intubation and, 48 hours after presentation, an MRI revealed multifocal diffuse T2 hyperintensity throughout his brain and spinal cord.  CSF examination revealed 27 leucocytes, 40 erythrocytes, glucose of 80 and protein of 113.  He had an elevated myelin basic protein level (6.0).  Oligoclonal bands were absent.  The man started receiving high-dose methylprednisolone sodium succinate, but remained obtunded and quadriplegic with hyperreflexia.  On day 7 of symptoms, he received a 5% IVIG 2 g/kg infusion over 8 hours followed by steroid taper.  Within 12 hours, he was able to raise his arm and, within 48 hours, he regained spontaneous eye opening.  He was extubated and, 19 days after IVIG therapy, fine motor control had returned to his upper extremities.  However, his recovery plateaued after 2 weeks.  He then received IVIG 150g boluses at weeks 3 and 4, but showed minimal improvement.  By the 4th week, sensory deficits had recovered down to his umbilicus.  He was subsequently transferred to another facility and, at that time, he had good strength and fine motor control of his upper extremities.  He also could move his right lower extremity with gravity, but his left lower extremity remained significantly impaired.  Over the next year, he showed improvement following physical and occupational therapy.  He continued to have detrusor sphincter dyssynergia and required cholinergic receptor antagonists and daily catheterisation."
Age: 20.0
Sex: M
Vaccine: SMALL, TYP, TYP
Symptoms: CSF protein increased, CSF test normal, CSF white blood cell count positive, Culture negative, Depressed level of consciousness
Clinical narrative: The following information was obtained from the above-referenced literature article received on 14 August 2008.  The author wrote: "A 20-year-old man developed acute disseminated encephalomyelitis after receiving smallpox vaccine and typhoid vaccine (dosages not stated).  He was successfully treated with immune globulin (IVIG).  The man received smallpox vaccine, and 2 days later, received typhoid vaccine.  Twelve days after receiving smallpox vaccine, he developed an ascending , circumferential numbness in his lower extremities that progressed to profound muscle weakness over 24 hours.  He had decreased sensation up to his nipple line, symmetric hyperreflexia with 3-4 beat clonus, and significant lower extremity weakness.  Catheterisation produced 900mL of urine.  Within hours of presentation, he required intubation and, 48 hours after presentation, an MRI revealed multifocal diffuse T2 hyperintensity throughout his brain and spinal cord.  CSF examination revealed 27 leucocytes, 40 erythrocytes, glucose of 80 and protein of 113.  He had an elevated myelin basic protein level (6.0).  Oligoclonal bands were absent.  The man started receiving high-dose methylprednisolone sodium succinate, but remained obtunded and quadriplegic with hyperreflexia.  On day 7 of symptoms, he received a 5% IVIG 2 g/kg infusion over 8 hours followed by steroid taper.  Within 12 hours, he was able to raise his arm and, within 48 hours, he regained spontaneous eye opening.  He was extubated and, 19 days after IVIG therapy, fine motor control had returned to his upper extremities.  However, his recovery plateaued after 2 weeks.  He then received IVIG 150g boluses at weeks 3 and 4, but showed minimal improvement.  By the 4th week, sensory deficits had recovered down to his umbilicus.  He was subsequently transferred to another facility and, at that time, he had good strength and fine motor control of his upper extremities.  He also could move his right lower extremity with gravity, but his left lower extremity remained significantly impaired.  Over the next year, he showed improvement following physical and occupational therapy.  He continued to have detrusor sphincter dyssynergia and required cholinergic receptor antagonists and daily catheterisation."
Age: 20.0
Sex: M
Vaccine: SMALL, TYP, TYP
Symptoms: Detrusor sphincter dyssynergia, Endotracheal intubation, Extubation, Hyperreflexia, Hypoaesthesia
Clinical narrative: The following information was obtained from the above-referenced literature article received on 14 August 2008.  The author wrote: "A 20-year-old man developed acute disseminated encephalomyelitis after receiving smallpox vaccine and typhoid vaccine (dosages not stated).  He was successfully treated with immune globulin (IVIG).  The man received smallpox vaccine, and 2 days later, received typhoid vaccine.  Twelve days after receiving smallpox vaccine, he developed an ascending , circumferential numbness in his lower extremities that progressed to profound muscle weakness over 24 hours.  He had decreased sensation up to his nipple line, symmetric hyperreflexia with 3-4 beat clonus, and significant lower extremity weakness.  Catheterisation produced 900mL of urine.  Within hours of presentation, he required intubation and, 48 hours after presentation, an MRI revealed multifocal diffuse T2 hyperintensity throughout his brain and spinal cord.  CSF examination revealed 27 leucocytes, 40 erythrocytes, glucose of 80 and protein of 113.  He had an elevated myelin basic protein level (6.0).  Oligoclonal bands were absent.  The man started receiving high-dose methylprednisolone sodium succinate, but remained obtunded and quadriplegic with hyperreflexia.  On day 7 of symptoms, he received a 5% IVIG 2 g/kg infusion over 8 hours followed by steroid taper.  Within 12 hours, he was able to raise his arm and, within 48 hours, he regained spontaneous eye opening.  He was extubated and, 19 days after IVIG therapy, fine motor control had returned to his upper extremities.  However, his recovery plateaued after 2 weeks.  He then received IVIG 150g boluses at weeks 3 and 4, but showed minimal improvement.  By the 4th week, sensory deficits had recovered down to his umbilicus.  He was subsequently transferred to another facility and, at that time, he had good strength and fine motor control of his upper extremities.  He also could move his right lower extremity with gravity, but his left lower extremity remained significantly impaired.  Over the next year, he showed improvement following physical and occupational therapy.  He continued to have detrusor sphincter dyssynergia and required cholinergic receptor antagonists and daily catheterisation."
Age: 20.0
Sex: M
Vaccine: SMALL, TYP, TYP
Symptoms: Leukoencephalomyelitis, Muscular weakness, Nuclear magnetic resonance imaging abnormal, Quadriplegia, Red blood cells CSF positive
Clinical narrative: The following information was obtained from the above-referenced literature article received on 14 August 2008.  The author wrote: "A 20-year-old man developed acute disseminated encephalomyelitis after receiving smallpox vaccine and typhoid vaccine (dosages not stated).  He was successfully treated with immune globulin (IVIG).  The man received smallpox vaccine, and 2 days later, received typhoid vaccine.  Twelve days after receiving smallpox vaccine, he developed an ascending , circumferential numbness in his lower extremities that progressed to profound muscle weakness over 24 hours.  He had decreased sensation up to his nipple line, symmetric hyperreflexia with 3-4 beat clonus, and significant lower extremity weakness.  Catheterisation produced 900mL of urine.  Within hours of presentation, he required intubation and, 48 hours after presentation, an MRI revealed multifocal diffuse T2 hyperintensity throughout his brain and spinal cord.  CSF examination revealed 27 leucocytes, 40 erythrocytes, glucose of 80 and protein of 113.  He had an elevated myelin basic protein level (6.0).  Oligoclonal bands were absent.  The man started receiving high-dose methylprednisolone sodium succinate, but remained obtunded and quadriplegic with hyperreflexia.  On day 7 of symptoms, he received a 5% IVIG 2 g/kg infusion over 8 hours followed by steroid taper.  Within 12 hours, he was able to raise his arm and, within 48 hours, he regained spontaneous eye opening.  He was extubated and, 19 days after IVIG therapy, fine motor control had returned to his upper extremities.  However, his recovery plateaued after 2 weeks.  He then received IVIG 150g boluses at weeks 3 and 4, but showed minimal improvement.  By the 4th week, sensory deficits had recovered down to his umbilicus.  He was subsequently transferred to another facility and, at that time, he had good strength and fine motor control of his upper extremities.  He also could move his right lower extremity with gravity, but his left lower extremity remained significantly impaired.  Over the next year, he showed improvement following physical and occupational therapy.  He continued to have detrusor sphincter dyssynergia and required cholinergic receptor antagonists and daily catheterisation."