chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: FLU(H1N1), FLU3, HEPA, TYP, YF
Symptoms: Chromaturia, Diarrhoea, Faeces pale, Fatigue, Hepatitis A antibody negative
Clinical narrative: Initial case was received on 29 June 2010 from a healthcare professional. A 17 year old male patient received on 09 June 2010 a left deltoid intramuscular injection of FLUZONE SV 2009-2010 (lot number not reported), a right deltoid intramuscular injection of TYPHIM Vi (lot number not reported), a left deltoid subcutaneous injection of YF VAX (lot number UF716AA), a right deltoid intramuscular injection of H1N1 (Manufacturer CSL-lot number not reported) and a left deltoid intramuscular injection of Hep A. On the evening of the vaccinations (09 June 2010), the patient began feeling tired and having body aches. Then 24 to 48 hours later he had yellowing of eyes, darker urine (stated as "beer brown"), loose and lighter in color stools, felt achy and not feeling well. On an unspecified date a liver function test was "greatly elevated" and titer for Hep A, B, C was negative. The patient was seen by a primary care physician (PCP) and was referred to a gastroenterologist, who after evaluation felt these symptoms were related to (R/t) the minocycline the patient had been on intermittently for 1 to 2 years. No treatment was reported. The patient had no illness at the time of the vaccinations. His medical history included acne and his concomitant medication was the minocycline. He had no adverse events following prior vaccinations. The patient had recovered on an unspecified date. Documents held by sender: None.
Age: 17.0
Sex: M
Vaccine: FLU(H1N1), FLU3, HEPA, TYP, YF
Symptoms: Hepatitis B antibody negative, Hepatitis C antibody negative, Liver function test abnormal, Malaise, Ocular icterus
Clinical narrative: Initial case was received on 29 June 2010 from a healthcare professional. A 17 year old male patient received on 09 June 2010 a left deltoid intramuscular injection of FLUZONE SV 2009-2010 (lot number not reported), a right deltoid intramuscular injection of TYPHIM Vi (lot number not reported), a left deltoid subcutaneous injection of YF VAX (lot number UF716AA), a right deltoid intramuscular injection of H1N1 (Manufacturer CSL-lot number not reported) and a left deltoid intramuscular injection of Hep A. On the evening of the vaccinations (09 June 2010), the patient began feeling tired and having body aches. Then 24 to 48 hours later he had yellowing of eyes, darker urine (stated as "beer brown"), loose and lighter in color stools, felt achy and not feeling well. On an unspecified date a liver function test was "greatly elevated" and titer for Hep A, B, C was negative. The patient was seen by a primary care physician (PCP) and was referred to a gastroenterologist, who after evaluation felt these symptoms were related to (R/t) the minocycline the patient had been on intermittently for 1 to 2 years. No treatment was reported. The patient had no illness at the time of the vaccinations. His medical history included acne and his concomitant medication was the minocycline. He had no adverse events following prior vaccinations. The patient had recovered on an unspecified date. Documents held by sender: None.
Age: 17.0
Sex: M
Vaccine: FLU(H1N1), FLU3, HEPA, TYP, YF
Symptoms: Pain
Clinical narrative: Initial case was received on 29 June 2010 from a healthcare professional. A 17 year old male patient received on 09 June 2010 a left deltoid intramuscular injection of FLUZONE SV 2009-2010 (lot number not reported), a right deltoid intramuscular injection of TYPHIM Vi (lot number not reported), a left deltoid subcutaneous injection of YF VAX (lot number UF716AA), a right deltoid intramuscular injection of H1N1 (Manufacturer CSL-lot number not reported) and a left deltoid intramuscular injection of Hep A. On the evening of the vaccinations (09 June 2010), the patient began feeling tired and having body aches. Then 24 to 48 hours later he had yellowing of eyes, darker urine (stated as "beer brown"), loose and lighter in color stools, felt achy and not feeling well. On an unspecified date a liver function test was "greatly elevated" and titer for Hep A, B, C was negative. The patient was seen by a primary care physician (PCP) and was referred to a gastroenterologist, who after evaluation felt these symptoms were related to (R/t) the minocycline the patient had been on intermittently for 1 to 2 years. No treatment was reported. The patient had no illness at the time of the vaccinations. His medical history included acne and his concomitant medication was the minocycline. He had no adverse events following prior vaccinations. The patient had recovered on an unspecified date. Documents held by sender: None.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU(H1N1), IPV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Fever 7/6/2010 at night at 10:00 pm. Redness 38mm x 45mm - PCV-LD 50mm x 44mm-MMR-RD.
Age: 0.39
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Body temperature increased, Convulsion
Clinical narrative: Temperature of 104. 6 hours after vaccine. Seizure 6hrs. after vaccine. Admitted 7/5/10 to hospital for seizure recurrence.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA, PNC13, VARCEL
Symptoms: Swelling face, Urticaria, Vomiting
Clinical narrative: Pt received all listed vaccines & approx 10 mins later started with hives & lead to facial swelling. Pt was placed on continuous SaO2 reading @ 98-100% without resp distress noted. Vomited x 1 episode. Pt was given 1 tsp Children's BENADRYL liquid PO at 3:45pm then was given EPIPEN Jr x 1 in Lt thigh IM @ 3:58pm. Pt obs'd until 4:30pm and released to parents in stable condition with b/s to call "911" for.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial palsy
Clinical narrative: Pt had paralysis side of face, Dx Bells Palsy.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Fall, Neurological examination normal, Tremor
Clinical narrative: Pt given VZV, MMR, KINRIX->went to 2nd floor of building w/ mom-was playing and then fell down per her mother and then was shaking. No loss of consciousness per mother. No loss of bowel/bladder control. Questionable seizure, but no postictal phase. Neuro exam normal pt was examined & was asymptomatic.
Age: 14.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: (R) upper arm (bicep area): Circular, red indurated area, sl. warm to touch, tender to touch. Fever: 103.1. TX: -Ibuprofen prn. - BENADRYL q 6-8 hrs prn. - Cool compresses to area.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Hypersensitivity, Injection site reaction
Clinical narrative: Pt had a reaction to (L) arm when vaccine was administered.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site induration, Oedema peripheral
Clinical narrative: Lt arm with circumference 9", rt circ 8.5 both mid near deltoid measured no red streaks but mild induration, no increased tp of lt sight.
Age: 26.0
Sex: M
Vaccine: TDAP, TYP
Symptoms: Chills, Headache, Nausea, Pain, Vomiting
Clinical narrative: Nausea, Headache, Excessive Vomiting, Chills, Aches: No Treatment.
Age: 22.0
Sex: F
Vaccine: TYP
Symptoms: Pruritus
Clinical narrative: Itchiness on arms, legs, head, neck, and face area.
Age: 53.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, Muscular weakness
Clinical narrative: Shortness of breath, fatigue, sudden weakness in the legs, weirdness.. something I never felt since I was born.. just like a rocking chair feeling.
Age: 49.0
Sex: M
Vaccine: YF
Symptoms: Odynophagia, Oropharyngeal pain, Throat tightness
Clinical narrative: Member was identified as due for yellow fever vaccination. Vaccine was administered per unit policy and vaccine directions. Approximately thirty minutes after vaccination, the member complained of soreness/tightness in throat during swallowing. Member was evaluated by a provider and released to full duty with instructions to return to provider if symptoms worsened.
Age: 60.0
Sex: M
Vaccine: DTAP
Symptoms: Blood lactic acid normal, Full blood count normal, Pallor, Pyrexia, Rash erythematous
Clinical narrative: Diffuse, pruritic, erythematous, blanchable, macular rash. Sparing mucous membranes, palms and soles. +fevers (Tmax-101.4)
Age: 60.0
Sex: M
Vaccine: DTAP
Symptoms: Rash macular, Rash pruritic
Clinical narrative: Diffuse, pruritic, erythematous, blanchable, macular rash. Sparing mucous membranes, palms and soles. +fevers (Tmax-101.4)
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, PPV
Symptoms: Aggression, Convulsion, Dysarthria, Electroencephalogram, Fatigue
Clinical narrative: Child began clawing at his face and mouth on the 10th.  Eye tics set in later that week - tics so bad he was unable to walk through them.  Rushed to ER for suspected seizures.  Has been to multiple specialists and systems have continued to get worse including:  tics, slurred speech, difficulty walking, extreme fatigue, constant screaming and screeching, complaints of headaches, arm swinging, head banging, repetitive behaviors, aggressive behavior.  Before this date he was a normal, happy, healthy, well adjusted toddler.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, PPV
Symptoms: Gait disturbance, Head banging, Headache, Liver function test, Nuclear magnetic resonance imaging
Clinical narrative: Child began clawing at his face and mouth on the 10th.  Eye tics set in later that week - tics so bad he was unable to walk through them.  Rushed to ER for suspected seizures.  Has been to multiple specialists and systems have continued to get worse including:  tics, slurred speech, difficulty walking, extreme fatigue, constant screaming and screeching, complaints of headaches, arm swinging, head banging, repetitive behaviors, aggressive behavior.  Before this date he was a normal, happy, healthy, well adjusted toddler.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, PPV
Symptoms: Screaming, Thyroid function test, Tic
Clinical narrative: Child began clawing at his face and mouth on the 10th.  Eye tics set in later that week - tics so bad he was unable to walk through them.  Rushed to ER for suspected seizures.  Has been to multiple specialists and systems have continued to get worse including:  tics, slurred speech, difficulty walking, extreme fatigue, constant screaming and screeching, complaints of headaches, arm swinging, head banging, repetitive behaviors, aggressive behavior.  Before this date he was a normal, happy, healthy, well adjusted toddler.
Age: 29.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site infection, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Infection below vaccination site; large red swollen area on arm, hot to touch, swollen arm; low-grade fever.
Age: 29.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Infection below vaccination site; large red swollen area on arm, hot to touch, swollen arm; low-grade fever.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Blister, Erythema, Oedema peripheral
Clinical narrative: Swollen red arm with swath of blisters serum filled about 4".
Age: 13.0
Sex: F
Vaccine: MEN, MMR, TDAP, VARCEL
Symptoms: Dyskinesia, Fall, Head injury, Mouth haemorrhage, Mouth injury
Clinical narrative: Patient fainted while sitting - proceeding to stand from a pediatric exam table and landed on her head and face on the floor and hit her head on a bench.  She was bleeding from her mouth and her braces perforated her lips and she suffered facial abrasions.  Immediately after landing her upper body was spasming or jerking.  Patient has scarring to her lip and chin.
Age: 13.0
Sex: F
Vaccine: MEN, MMR, TDAP, VARCEL
Symptoms: Muscle spasms, Scar, Syncope
Clinical narrative: Patient fainted while sitting - proceeding to stand from a pediatric exam table and landed on her head and face on the floor and hit her head on a bench.  She was bleeding from her mouth and her braces perforated her lips and she suffered facial abrasions.  Immediately after landing her upper body was spasming or jerking.  Patient has scarring to her lip and chin.
Age: 2.0
Sex: M
Vaccine: HEPA, MMR, PPV
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: Fever of 103.3, measles-like rash on body. Gave ibuprofen followed by acetaminophen 3 hours later.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Blood test, Erythema, Fatigue, Injection site reaction, Irritability
Clinical narrative: I had already noticed the day before a "sandpaper" feel to her cheeks but on the 4th, her cheeks became really red & bumpy. She was "cranky" that afternoon & tired; she laid down on her own to take a nap which rarely happens. Over the next few days her cheeks became even more irritated, she was scratching herself all over & I noticed the sandpaper feel on her arms & legs. On the morning of Fri July 9, she had tiny red bumps on her torso & back & her cheeks were extremely flared & rashy when she woke in the AM. I called the Drs office when I realized she was probably having a reaction to the MMR vax. She was also scratching more on her arms; big patches of rash. I took her in around 10:30am & she was seen by Dr at her Pedi office. Dr. told me that the rash doesn't look like a "normal" reaction rash but the red spots were broken blood vessels under her skin so she ordered a complete blood work test to make sure her platelets were ok. At the time I was unaware that the MMR could cause a decrease in platelets. But when I researched online, her rash looks just like pics referring to Rubella/Measels rash. That Fri afternoon (4:30), I received a call from Dr saying that patient's blood tests came back ok. The rash continued to spread & had covered her bottom by Sat morning (7-10-10) I took pics to document her rash covered body on Sat afternoon. Dr prescribed Mometasonbe 0.1% cream for her which I have been reluctant to use after reading the warnings/side effects. It is currently Sun morning (7-11-10) & she woke itchy & scratching all over but continues to have an appetite & otherwise normal except with complaints of feeling tired & maybe a very low grade fever. Her cheeks are still warm to the touch.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Pyrexia, Rash, Rash erythematous, Skin warm
Clinical narrative: I had already noticed the day before a "sandpaper" feel to her cheeks but on the 4th, her cheeks became really red & bumpy. She was "cranky" that afternoon & tired; she laid down on her own to take a nap which rarely happens. Over the next few days her cheeks became even more irritated, she was scratching herself all over & I noticed the sandpaper feel on her arms & legs. On the morning of Fri July 9, she had tiny red bumps on her torso & back & her cheeks were extremely flared & rashy when she woke in the AM. I called the Drs office when I realized she was probably having a reaction to the MMR vax. She was also scratching more on her arms; big patches of rash. I took her in around 10:30am & she was seen by Dr at her Pedi office. Dr. told me that the rash doesn't look like a "normal" reaction rash but the red spots were broken blood vessels under her skin so she ordered a complete blood work test to make sure her platelets were ok. At the time I was unaware that the MMR could cause a decrease in platelets. But when I researched online, her rash looks just like pics referring to Rubella/Measels rash. That Fri afternoon (4:30), I received a call from Dr saying that patient's blood tests came back ok. The rash continued to spread & had covered her bottom by Sat morning (7-10-10) I took pics to document her rash covered body on Sat afternoon. Dr prescribed Mometasonbe 0.1% cream for her which I have been reluctant to use after reading the warnings/side effects. It is currently Sun morning (7-11-10) & she woke itchy & scratching all over but continues to have an appetite & otherwise normal except with complaints of feeling tired & maybe a very low grade fever. Her cheeks are still warm to the touch.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Vaccination complication
Clinical narrative: I had already noticed the day before a "sandpaper" feel to her cheeks but on the 4th, her cheeks became really red & bumpy. She was "cranky" that afternoon & tired; she laid down on her own to take a nap which rarely happens. Over the next few days her cheeks became even more irritated, she was scratching herself all over & I noticed the sandpaper feel on her arms & legs. On the morning of Fri July 9, she had tiny red bumps on her torso & back & her cheeks were extremely flared & rashy when she woke in the AM. I called the Drs office when I realized she was probably having a reaction to the MMR vax. She was also scratching more on her arms; big patches of rash. I took her in around 10:30am & she was seen by Dr at her Pedi office. Dr. told me that the rash doesn't look like a "normal" reaction rash but the red spots were broken blood vessels under her skin so she ordered a complete blood work test to make sure her platelets were ok. At the time I was unaware that the MMR could cause a decrease in platelets. But when I researched online, her rash looks just like pics referring to Rubella/Measels rash. That Fri afternoon (4:30), I received a call from Dr saying that patient's blood tests came back ok. The rash continued to spread & had covered her bottom by Sat morning (7-10-10) I took pics to document her rash covered body on Sat afternoon. Dr prescribed Mometasonbe 0.1% cream for her which I have been reluctant to use after reading the warnings/side effects. It is currently Sun morning (7-11-10) & she woke itchy & scratching all over but continues to have an appetite & otherwise normal except with complaints of feeling tired & maybe a very low grade fever. Her cheeks are still warm to the touch.
Age: 27.0
Sex: M
Vaccine: HEP, TD, TYP
Symptoms: Anxiety, Cold sweat
Clinical narrative: Felt cold sweats and anxious.
Age: 18.0
Sex: M
Vaccine: BCG, FLUN3, HEPAB, MMR, MNQ, TDAP, VARCEL, BCG, FLUN3, HEPAB, MMR, MNQ, TDAP, VARCEL
Symptoms: Aphonia, Axonal neuropathy, Chest X-ray abnormal, Chills, Computerised tomogram normal
Clinical narrative: Initial report received from the Centers for Disease Control and Prevention (CDC) on 08 September 2009 and follow-up information on 16 September 2009 (VAERS number 336045). An 18-year-old male patient, with no reported medical history, received the following vaccinations on 22 September 2008: a left leg intramuscular dose of ADACEL (lot number C2998BA); an intramuscular dose of MENACTRA (lot number U2656AA); an intramuscular dose of BCG (lot number 52064); an intranasal dose of FLUMIST (Medimmune, lot number 500560P); MMR II (Merck, lot number 0356X); an intramuscular left leg dose of TWINRIX (GlaxoSmithKline, lot number AHAB128AB); and a subcutaneous dose of VARIVAX (lot number 0973). On 06 October 2008, 14 days post-vaccination, the patient complained of fever, chills, congestion, runny nose, sore throat, nausea, and a productive cough. He was diagnosed with an upper respiratory infection at that time, and symptoms resolved in four days. On 15 October 2009, he presented to the emergency department with complaints of numbness and tingling in both hands and feet, and in his mouth, and weakness in the lower extremities while trying to climb stairs. At that time the impression was progressive idiopathic polyneuropathy. On 16 October 2008, he began developing progressive neurologic symptoms consistent with GUILLAIN-BARRE syndrome, including aphonia, dysphagia, and acute sensorimotor neurological deficits. He progressed to respiratory failure, and required mechanical ventilation and subsequent tracheostomy. CT and MRI of the head and echocardiogram were normal. A chest x-ray showed an infiltration. Electrodiagnostic studies revealed abnormal-non-recordable latency of bilateral phrenic nerves and highly suggestive of demyelinating and axonal polyneuropathy predominantly involving motor nerves. Reticulocyte count was increased, and he developed hyperbilirubinemia. Diagnosis suggested hereditary hemolytic anemia vs. severe sepsis as cause of hemolysis. White blood count was 27.2. He was treated with intravenous immunoglobulins and plasmapheresis. During his hospitalization, he also developed orchitis, tachycardia, hypertension, and aspiration pneumonia. He remained hospitalized for 28 days and was discharged on 13 November 2008. Outcome was unknown. From the additional information received on 16 September 2009 from the CDC, this case was evaluated by the Clinical Immunization Safety Assessment network (CISA) and determined to meet the proposed Brighton Collaboration case definition of GUILLAIN-BARRE SYNDROME, with a level 2 of diagnostic certainty. Documents held by sender: None.
Age: 18.0
Sex: M
Vaccine: BCG, FLUN3, HEPAB, MMR, MNQ, TDAP, VARCEL, BCG, FLUN3, HEPAB, MMR, MNQ, TDAP, VARCEL
Symptoms: Demyelinating polyneuropathy, Dysphagia, Echocardiogram normal, Electrocardiogram abnormal, Electromyogram abnormal
Clinical narrative: Initial report received from the Centers for Disease Control and Prevention (CDC) on 08 September 2009 and follow-up information on 16 September 2009 (VAERS number 336045). An 18-year-old male patient, with no reported medical history, received the following vaccinations on 22 September 2008: a left leg intramuscular dose of ADACEL (lot number C2998BA); an intramuscular dose of MENACTRA (lot number U2656AA); an intramuscular dose of BCG (lot number 52064); an intranasal dose of FLUMIST (Medimmune, lot number 500560P); MMR II (Merck, lot number 0356X); an intramuscular left leg dose of TWINRIX (GlaxoSmithKline, lot number AHAB128AB); and a subcutaneous dose of VARIVAX (lot number 0973). On 06 October 2008, 14 days post-vaccination, the patient complained of fever, chills, congestion, runny nose, sore throat, nausea, and a productive cough. He was diagnosed with an upper respiratory infection at that time, and symptoms resolved in four days. On 15 October 2009, he presented to the emergency department with complaints of numbness and tingling in both hands and feet, and in his mouth, and weakness in the lower extremities while trying to climb stairs. At that time the impression was progressive idiopathic polyneuropathy. On 16 October 2008, he began developing progressive neurologic symptoms consistent with GUILLAIN-BARRE syndrome, including aphonia, dysphagia, and acute sensorimotor neurological deficits. He progressed to respiratory failure, and required mechanical ventilation and subsequent tracheostomy. CT and MRI of the head and echocardiogram were normal. A chest x-ray showed an infiltration. Electrodiagnostic studies revealed abnormal-non-recordable latency of bilateral phrenic nerves and highly suggestive of demyelinating and axonal polyneuropathy predominantly involving motor nerves. Reticulocyte count was increased, and he developed hyperbilirubinemia. Diagnosis suggested hereditary hemolytic anemia vs. severe sepsis as cause of hemolysis. White blood count was 27.2. He was treated with intravenous immunoglobulins and plasmapheresis. During his hospitalization, he also developed orchitis, tachycardia, hypertension, and aspiration pneumonia. He remained hospitalized for 28 days and was discharged on 13 November 2008. Outcome was unknown. From the additional information received on 16 September 2009 from the CDC, this case was evaluated by the Clinical Immunization Safety Assessment network (CISA) and determined to meet the proposed Brighton Collaboration case definition of GUILLAIN-BARRE SYNDROME, with a level 2 of diagnostic certainty. Documents held by sender: None.
Age: 18.0
Sex: M
Vaccine: BCG, FLUN3, HEPAB, MMR, MNQ, TDAP, VARCEL, BCG, FLUN3, HEPAB, MMR, MNQ, TDAP, VARCEL
Symptoms: Guillain-Barre syndrome, Haemolysis, Hyperbilirubinaemia, Hypertension, Hypoaesthesia
Clinical narrative: Initial report received from the Centers for Disease Control and Prevention (CDC) on 08 September 2009 and follow-up information on 16 September 2009 (VAERS number 336045). An 18-year-old male patient, with no reported medical history, received the following vaccinations on 22 September 2008: a left leg intramuscular dose of ADACEL (lot number C2998BA); an intramuscular dose of MENACTRA (lot number U2656AA); an intramuscular dose of BCG (lot number 52064); an intranasal dose of FLUMIST (Medimmune, lot number 500560P); MMR II (Merck, lot number 0356X); an intramuscular left leg dose of TWINRIX (GlaxoSmithKline, lot number AHAB128AB); and a subcutaneous dose of VARIVAX (lot number 0973). On 06 October 2008, 14 days post-vaccination, the patient complained of fever, chills, congestion, runny nose, sore throat, nausea, and a productive cough. He was diagnosed with an upper respiratory infection at that time, and symptoms resolved in four days. On 15 October 2009, he presented to the emergency department with complaints of numbness and tingling in both hands and feet, and in his mouth, and weakness in the lower extremities while trying to climb stairs. At that time the impression was progressive idiopathic polyneuropathy. On 16 October 2008, he began developing progressive neurologic symptoms consistent with GUILLAIN-BARRE syndrome, including aphonia, dysphagia, and acute sensorimotor neurological deficits. He progressed to respiratory failure, and required mechanical ventilation and subsequent tracheostomy. CT and MRI of the head and echocardiogram were normal. A chest x-ray showed an infiltration. Electrodiagnostic studies revealed abnormal-non-recordable latency of bilateral phrenic nerves and highly suggestive of demyelinating and axonal polyneuropathy predominantly involving motor nerves. Reticulocyte count was increased, and he developed hyperbilirubinemia. Diagnosis suggested hereditary hemolytic anemia vs. severe sepsis as cause of hemolysis. White blood count was 27.2. He was treated with intravenous immunoglobulins and plasmapheresis. During his hospitalization, he also developed orchitis, tachycardia, hypertension, and aspiration pneumonia. He remained hospitalized for 28 days and was discharged on 13 November 2008. Outcome was unknown. From the additional information received on 16 September 2009 from the CDC, this case was evaluated by the Clinical Immunization Safety Assessment network (CISA) and determined to meet the proposed Brighton Collaboration case definition of GUILLAIN-BARRE SYNDROME, with a level 2 of diagnostic certainty. Documents held by sender: None.
Age: 18.0
Sex: M
Vaccine: BCG, FLUN3, HEPAB, MMR, MNQ, TDAP, VARCEL, BCG, FLUN3, HEPAB, MMR, MNQ, TDAP, VARCEL
Symptoms: Hypoaesthesia oral, Immunoglobulin therapy, Mechanical ventilation, Muscular weakness, Nasal congestion
Clinical narrative: Initial report received from the Centers for Disease Control and Prevention (CDC) on 08 September 2009 and follow-up information on 16 September 2009 (VAERS number 336045). An 18-year-old male patient, with no reported medical history, received the following vaccinations on 22 September 2008: a left leg intramuscular dose of ADACEL (lot number C2998BA); an intramuscular dose of MENACTRA (lot number U2656AA); an intramuscular dose of BCG (lot number 52064); an intranasal dose of FLUMIST (Medimmune, lot number 500560P); MMR II (Merck, lot number 0356X); an intramuscular left leg dose of TWINRIX (GlaxoSmithKline, lot number AHAB128AB); and a subcutaneous dose of VARIVAX (lot number 0973). On 06 October 2008, 14 days post-vaccination, the patient complained of fever, chills, congestion, runny nose, sore throat, nausea, and a productive cough. He was diagnosed with an upper respiratory infection at that time, and symptoms resolved in four days. On 15 October 2009, he presented to the emergency department with complaints of numbness and tingling in both hands and feet, and in his mouth, and weakness in the lower extremities while trying to climb stairs. At that time the impression was progressive idiopathic polyneuropathy. On 16 October 2008, he began developing progressive neurologic symptoms consistent with GUILLAIN-BARRE syndrome, including aphonia, dysphagia, and acute sensorimotor neurological deficits. He progressed to respiratory failure, and required mechanical ventilation and subsequent tracheostomy. CT and MRI of the head and echocardiogram were normal. A chest x-ray showed an infiltration. Electrodiagnostic studies revealed abnormal-non-recordable latency of bilateral phrenic nerves and highly suggestive of demyelinating and axonal polyneuropathy predominantly involving motor nerves. Reticulocyte count was increased, and he developed hyperbilirubinemia. Diagnosis suggested hereditary hemolytic anemia vs. severe sepsis as cause of hemolysis. White blood count was 27.2. He was treated with intravenous immunoglobulins and plasmapheresis. During his hospitalization, he also developed orchitis, tachycardia, hypertension, and aspiration pneumonia. He remained hospitalized for 28 days and was discharged on 13 November 2008. Outcome was unknown. From the additional information received on 16 September 2009 from the CDC, this case was evaluated by the Clinical Immunization Safety Assessment network (CISA) and determined to meet the proposed Brighton Collaboration case definition of GUILLAIN-BARRE SYNDROME, with a level 2 of diagnostic certainty. Documents held by sender: None.
Age: 18.0
Sex: M
Vaccine: BCG, FLUN3, HEPAB, MMR, MNQ, TDAP, VARCEL, BCG, FLUN3, HEPAB, MMR, MNQ, TDAP, VARCEL
Symptoms: Nausea, Nerve conduction studies abnormal, Nuclear magnetic resonance imaging normal, Orchitis, Oropharyngeal pain
Clinical narrative: Initial report received from the Centers for Disease Control and Prevention (CDC) on 08 September 2009 and follow-up information on 16 September 2009 (VAERS number 336045). An 18-year-old male patient, with no reported medical history, received the following vaccinations on 22 September 2008: a left leg intramuscular dose of ADACEL (lot number C2998BA); an intramuscular dose of MENACTRA (lot number U2656AA); an intramuscular dose of BCG (lot number 52064); an intranasal dose of FLUMIST (Medimmune, lot number 500560P); MMR II (Merck, lot number 0356X); an intramuscular left leg dose of TWINRIX (GlaxoSmithKline, lot number AHAB128AB); and a subcutaneous dose of VARIVAX (lot number 0973). On 06 October 2008, 14 days post-vaccination, the patient complained of fever, chills, congestion, runny nose, sore throat, nausea, and a productive cough. He was diagnosed with an upper respiratory infection at that time, and symptoms resolved in four days. On 15 October 2009, he presented to the emergency department with complaints of numbness and tingling in both hands and feet, and in his mouth, and weakness in the lower extremities while trying to climb stairs. At that time the impression was progressive idiopathic polyneuropathy. On 16 October 2008, he began developing progressive neurologic symptoms consistent with GUILLAIN-BARRE syndrome, including aphonia, dysphagia, and acute sensorimotor neurological deficits. He progressed to respiratory failure, and required mechanical ventilation and subsequent tracheostomy. CT and MRI of the head and echocardiogram were normal. A chest x-ray showed an infiltration. Electrodiagnostic studies revealed abnormal-non-recordable latency of bilateral phrenic nerves and highly suggestive of demyelinating and axonal polyneuropathy predominantly involving motor nerves. Reticulocyte count was increased, and he developed hyperbilirubinemia. Diagnosis suggested hereditary hemolytic anemia vs. severe sepsis as cause of hemolysis. White blood count was 27.2. He was treated with intravenous immunoglobulins and plasmapheresis. During his hospitalization, he also developed orchitis, tachycardia, hypertension, and aspiration pneumonia. He remained hospitalized for 28 days and was discharged on 13 November 2008. Outcome was unknown. From the additional information received on 16 September 2009 from the CDC, this case was evaluated by the Clinical Immunization Safety Assessment network (CISA) and determined to meet the proposed Brighton Collaboration case definition of GUILLAIN-BARRE SYNDROME, with a level 2 of diagnostic certainty. Documents held by sender: None.
Age: 18.0
Sex: M
Vaccine: BCG, FLUN3, HEPAB, MMR, MNQ, TDAP, VARCEL, BCG, FLUN3, HEPAB, MMR, MNQ, TDAP, VARCEL
Symptoms: Paraesthesia, Paraesthesia oral, Plasmapheresis, Pneumonia aspiration, Polyneuropathy
Clinical narrative: Initial report received from the Centers for Disease Control and Prevention (CDC) on 08 September 2009 and follow-up information on 16 September 2009 (VAERS number 336045). An 18-year-old male patient, with no reported medical history, received the following vaccinations on 22 September 2008: a left leg intramuscular dose of ADACEL (lot number C2998BA); an intramuscular dose of MENACTRA (lot number U2656AA); an intramuscular dose of BCG (lot number 52064); an intranasal dose of FLUMIST (Medimmune, lot number 500560P); MMR II (Merck, lot number 0356X); an intramuscular left leg dose of TWINRIX (GlaxoSmithKline, lot number AHAB128AB); and a subcutaneous dose of VARIVAX (lot number 0973). On 06 October 2008, 14 days post-vaccination, the patient complained of fever, chills, congestion, runny nose, sore throat, nausea, and a productive cough. He was diagnosed with an upper respiratory infection at that time, and symptoms resolved in four days. On 15 October 2009, he presented to the emergency department with complaints of numbness and tingling in both hands and feet, and in his mouth, and weakness in the lower extremities while trying to climb stairs. At that time the impression was progressive idiopathic polyneuropathy. On 16 October 2008, he began developing progressive neurologic symptoms consistent with GUILLAIN-BARRE syndrome, including aphonia, dysphagia, and acute sensorimotor neurological deficits. He progressed to respiratory failure, and required mechanical ventilation and subsequent tracheostomy. CT and MRI of the head and echocardiogram were normal. A chest x-ray showed an infiltration. Electrodiagnostic studies revealed abnormal-non-recordable latency of bilateral phrenic nerves and highly suggestive of demyelinating and axonal polyneuropathy predominantly involving motor nerves. Reticulocyte count was increased, and he developed hyperbilirubinemia. Diagnosis suggested hereditary hemolytic anemia vs. severe sepsis as cause of hemolysis. White blood count was 27.2. He was treated with intravenous immunoglobulins and plasmapheresis. During his hospitalization, he also developed orchitis, tachycardia, hypertension, and aspiration pneumonia. He remained hospitalized for 28 days and was discharged on 13 November 2008. Outcome was unknown. From the additional information received on 16 September 2009 from the CDC, this case was evaluated by the Clinical Immunization Safety Assessment network (CISA) and determined to meet the proposed Brighton Collaboration case definition of GUILLAIN-BARRE SYNDROME, with a level 2 of diagnostic certainty. Documents held by sender: None.
Age: 18.0
Sex: M
Vaccine: BCG, FLUN3, HEPAB, MMR, MNQ, TDAP, VARCEL, BCG, FLUN3, HEPAB, MMR, MNQ, TDAP, VARCEL
Symptoms: Polyneuropathy idiopathic progressive, Productive cough, Pyrexia, Respiratory failure, Reticulocyte count increased
Clinical narrative: Initial report received from the Centers for Disease Control and Prevention (CDC) on 08 September 2009 and follow-up information on 16 September 2009 (VAERS number 336045). An 18-year-old male patient, with no reported medical history, received the following vaccinations on 22 September 2008: a left leg intramuscular dose of ADACEL (lot number C2998BA); an intramuscular dose of MENACTRA (lot number U2656AA); an intramuscular dose of BCG (lot number 52064); an intranasal dose of FLUMIST (Medimmune, lot number 500560P); MMR II (Merck, lot number 0356X); an intramuscular left leg dose of TWINRIX (GlaxoSmithKline, lot number AHAB128AB); and a subcutaneous dose of VARIVAX (lot number 0973). On 06 October 2008, 14 days post-vaccination, the patient complained of fever, chills, congestion, runny nose, sore throat, nausea, and a productive cough. He was diagnosed with an upper respiratory infection at that time, and symptoms resolved in four days. On 15 October 2009, he presented to the emergency department with complaints of numbness and tingling in both hands and feet, and in his mouth, and weakness in the lower extremities while trying to climb stairs. At that time the impression was progressive idiopathic polyneuropathy. On 16 October 2008, he began developing progressive neurologic symptoms consistent with GUILLAIN-BARRE syndrome, including aphonia, dysphagia, and acute sensorimotor neurological deficits. He progressed to respiratory failure, and required mechanical ventilation and subsequent tracheostomy. CT and MRI of the head and echocardiogram were normal. A chest x-ray showed an infiltration. Electrodiagnostic studies revealed abnormal-non-recordable latency of bilateral phrenic nerves and highly suggestive of demyelinating and axonal polyneuropathy predominantly involving motor nerves. Reticulocyte count was increased, and he developed hyperbilirubinemia. Diagnosis suggested hereditary hemolytic anemia vs. severe sepsis as cause of hemolysis. White blood count was 27.2. He was treated with intravenous immunoglobulins and plasmapheresis. During his hospitalization, he also developed orchitis, tachycardia, hypertension, and aspiration pneumonia. He remained hospitalized for 28 days and was discharged on 13 November 2008. Outcome was unknown. From the additional information received on 16 September 2009 from the CDC, this case was evaluated by the Clinical Immunization Safety Assessment network (CISA) and determined to meet the proposed Brighton Collaboration case definition of GUILLAIN-BARRE SYNDROME, with a level 2 of diagnostic certainty. Documents held by sender: None.
Age: 18.0
Sex: M
Vaccine: BCG, FLUN3, HEPAB, MMR, MNQ, TDAP, VARCEL, BCG, FLUN3, HEPAB, MMR, MNQ, TDAP, VARCEL
Symptoms: Rhinorrhoea, Sensorimotor disorder, Sepsis, Tachycardia, Tracheostomy
Clinical narrative: Initial report received from the Centers for Disease Control and Prevention (CDC) on 08 September 2009 and follow-up information on 16 September 2009 (VAERS number 336045). An 18-year-old male patient, with no reported medical history, received the following vaccinations on 22 September 2008: a left leg intramuscular dose of ADACEL (lot number C2998BA); an intramuscular dose of MENACTRA (lot number U2656AA); an intramuscular dose of BCG (lot number 52064); an intranasal dose of FLUMIST (Medimmune, lot number 500560P); MMR II (Merck, lot number 0356X); an intramuscular left leg dose of TWINRIX (GlaxoSmithKline, lot number AHAB128AB); and a subcutaneous dose of VARIVAX (lot number 0973). On 06 October 2008, 14 days post-vaccination, the patient complained of fever, chills, congestion, runny nose, sore throat, nausea, and a productive cough. He was diagnosed with an upper respiratory infection at that time, and symptoms resolved in four days. On 15 October 2009, he presented to the emergency department with complaints of numbness and tingling in both hands and feet, and in his mouth, and weakness in the lower extremities while trying to climb stairs. At that time the impression was progressive idiopathic polyneuropathy. On 16 October 2008, he began developing progressive neurologic symptoms consistent with GUILLAIN-BARRE syndrome, including aphonia, dysphagia, and acute sensorimotor neurological deficits. He progressed to respiratory failure, and required mechanical ventilation and subsequent tracheostomy. CT and MRI of the head and echocardiogram were normal. A chest x-ray showed an infiltration. Electrodiagnostic studies revealed abnormal-non-recordable latency of bilateral phrenic nerves and highly suggestive of demyelinating and axonal polyneuropathy predominantly involving motor nerves. Reticulocyte count was increased, and he developed hyperbilirubinemia. Diagnosis suggested hereditary hemolytic anemia vs. severe sepsis as cause of hemolysis. White blood count was 27.2. He was treated with intravenous immunoglobulins and plasmapheresis. During his hospitalization, he also developed orchitis, tachycardia, hypertension, and aspiration pneumonia. He remained hospitalized for 28 days and was discharged on 13 November 2008. Outcome was unknown. From the additional information received on 16 September 2009 from the CDC, this case was evaluated by the Clinical Immunization Safety Assessment network (CISA) and determined to meet the proposed Brighton Collaboration case definition of GUILLAIN-BARRE SYNDROME, with a level 2 of diagnostic certainty. Documents held by sender: None.
Age: 18.0
Sex: M
Vaccine: BCG, FLUN3, HEPAB, MMR, MNQ, TDAP, VARCEL, BCG, FLUN3, HEPAB, MMR, MNQ, TDAP, VARCEL
Symptoms: Upper respiratory tract congestion, White blood cell count increased
Clinical narrative: Initial report received from the Centers for Disease Control and Prevention (CDC) on 08 September 2009 and follow-up information on 16 September 2009 (VAERS number 336045). An 18-year-old male patient, with no reported medical history, received the following vaccinations on 22 September 2008: a left leg intramuscular dose of ADACEL (lot number C2998BA); an intramuscular dose of MENACTRA (lot number U2656AA); an intramuscular dose of BCG (lot number 52064); an intranasal dose of FLUMIST (Medimmune, lot number 500560P); MMR II (Merck, lot number 0356X); an intramuscular left leg dose of TWINRIX (GlaxoSmithKline, lot number AHAB128AB); and a subcutaneous dose of VARIVAX (lot number 0973). On 06 October 2008, 14 days post-vaccination, the patient complained of fever, chills, congestion, runny nose, sore throat, nausea, and a productive cough. He was diagnosed with an upper respiratory infection at that time, and symptoms resolved in four days. On 15 October 2009, he presented to the emergency department with complaints of numbness and tingling in both hands and feet, and in his mouth, and weakness in the lower extremities while trying to climb stairs. At that time the impression was progressive idiopathic polyneuropathy. On 16 October 2008, he began developing progressive neurologic symptoms consistent with GUILLAIN-BARRE syndrome, including aphonia, dysphagia, and acute sensorimotor neurological deficits. He progressed to respiratory failure, and required mechanical ventilation and subsequent tracheostomy. CT and MRI of the head and echocardiogram were normal. A chest x-ray showed an infiltration. Electrodiagnostic studies revealed abnormal-non-recordable latency of bilateral phrenic nerves and highly suggestive of demyelinating and axonal polyneuropathy predominantly involving motor nerves. Reticulocyte count was increased, and he developed hyperbilirubinemia. Diagnosis suggested hereditary hemolytic anemia vs. severe sepsis as cause of hemolysis. White blood count was 27.2. He was treated with intravenous immunoglobulins and plasmapheresis. During his hospitalization, he also developed orchitis, tachycardia, hypertension, and aspiration pneumonia. He remained hospitalized for 28 days and was discharged on 13 November 2008. Outcome was unknown. From the additional information received on 16 September 2009 from the CDC, this case was evaluated by the Clinical Immunization Safety Assessment network (CISA) and determined to meet the proposed Brighton Collaboration case definition of GUILLAIN-BARRE SYNDROME, with a level 2 of diagnostic certainty. Documents held by sender: None.
Age: 18.0
Sex: M
Vaccine: BCG, FLUN3, HEPAB, MMR, MNQ, TDAP, VARCEL, BCG, FLUN3, HEPAB, MMR, MNQ, TDAP, VARCEL
Symptoms: Aphonia, Chest X-ray abnormal, Chills, Computerised tomogram head, Demyelinating polyneuropathy
Clinical narrative: Initial report received from the Centers for Disease Control and Prevention (CDC) on 08 September 2009 and follow-up information on 16 September 2009 (VAERS number 336045). An 18-year-old male patient, with no reported medical history, received the following vaccinations on 22 September 2008: a left leg intramuscular dose of ADACEL (lot number C2998BA); an intramuscular dose of MENACTRA (lot number U2656AA); an intramuscular dose of BCG (lot number 52064); an intranasal dose of FLUMIST (Medimmune, lot number 500560P); MMR II (Merck, lot number 0356X); an intramuscular left leg dose of TWINRIX (GlaxoSmithKline, lot number AHAB128AB); and a subcutaneous dose of VARIVAX (lot number 0973). On 06 October 2008, 14 days post-vaccination, the patient complained of fever, chills, congestion, runny nose, sore throat, nausea, and a productive cough. He was diagnosed with an upper respiratory infection at that time, and symptoms resolved in four days. On 15 October 2009, he presented to the emergency department with complaints of numbness and tingling in both hands and feet, and in his mouth, and weakness in the lower extremities while trying to climb stairs. At that time the impression was progressive idiopathic polyneuropathy. On 16 October 2008, he began developing progressive neurologic symptoms consistent with GUILLAIN-BARRE syndrome, including aphonia, dysphagia, and acute sensorimotor neurological deficits. He progressed to respiratory failure, and required mechanical ventilation and subsequent tracheostomy. CT and MRI of the head and echocardiogram were normal. A chest x-ray showed an infiltration. Electrodiagnostic studies revealed abnormal-non-recordable latency of bilateral phrenic nerves and highly suggestive of demyelinating and axonal polyneuropathy predominantly involving motor nerves. Reticulocyte count was increased, and he developed hyperbilirubinemia. Diagnosis suggested hereditary hemolytic anemia vs. severe sepsis as cause of hemolysis. White blood count was 27.2. He was treated with intravenous immunoglobulins and plasmapheresis. During his hospitalization, he also developed orchitis, tachycardia, hypertension, and aspiration pneumonia. He remained hospitalized for 28 days and was discharged on 13 November 2008. Outcome was unknown. From the additional information received on 16 September 2009 from the CDC, this case was evaluated by the Clinical Immunization Safety Assessment network (CISA) and determined to meet the proposed Brighton Collaboration case definition of GUILLAIN-BARRE SYNDROME, with a level 2 of diagnostic certainty. Documents held by sender: None.