chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Diarrhoea, Dysphonia, Headache, Nausea, Paraesthesia
Clinical narrative: hoarseness- feeling of fullness in throat tingling of tongue nausea diarrhea headache blurry vision lo-grade fever
Age: 71.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Paraesthesia oral, Pharyngeal oedema, Pyrexia, Vision blurred
Clinical narrative: hoarseness- feeling of fullness in throat tingling of tongue nausea diarrhea headache blurry vision lo-grade fever
Age: 72.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: Uncontrollable shivering and shaking. 99 Fever raised to 101.6.  Took 2 naproxin and lots of bed covers.  Shivering stopped in about 1 hour, temp has continued for 2 more days.  Treating with ibuprofen.
Age: 8.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Dyskinesia, Myalgia
Clinical narrative: 18 days after receiving the H1N1 nasal mist, client developed jerking in her mid-section. After 1 week, jerking developed in shoulders, arms, hands, and feet, continuously. Has no control over jerking, mid-section stops jerking only when in a deep sleep. When she picks up a crayon, she drops it. Went to ER 2x's and Dr on 12-04-09 and 12-21-09. Want to send her to a neurologist in OKC 1 wk ago had muscle pain used tylenol muscle med for relief. Appetite ok.
Age: 35.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Decreased appetite, Headache, Nausea, Pain, Vomiting
Clinical narrative: nausea, aching, vomiting, headache, anorexia
Age: 6.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Erythema, Induration, Swelling, Tenderness
Clinical narrative: DTAP/HEP B - PED / IPV vaccine given in RA 12/15/09.  12/17/09 mom returned to clinic w/child w/ c/o right elbow to upper shoulder swollen/ red / hard/ tender to touch (twice size of arm) mom applied ice.  Seen 12/18/09 w/ decreased swelling & decreased tender to touch.
Age: 53.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Amnesia, Anxiety, Chills, Decreased appetite, Disorientation
Clinical narrative: 1st Day: Stroke like symptoms (numbness left side of face & left arm).  2nd Day:  Flu like symptoms (chills/fever -> 100.2 degrees).  3rd Day:  Severe headache (front of head/right side of head/back of neck).  4th Day:  Flu symptoms and headache gone.  However, left with vertigo type feeling, disorientation, memory loss, speech impaired, anxiety attacks, loss of appetite, liver discomfort.  5th -> 10 Day:  Still have vertigo type feeling, disorientation, memory loss, speech impaired, anxiety attacks, loss of appetite, liver discomfort.  Please send me a copy of the form you submit to the CDC.  Thank you.
Age: 53.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Headache, Hypoaesthesia, Hypoaesthesia facial, Liver tenderness, Pyrexia
Clinical narrative: 1st Day: Stroke like symptoms (numbness left side of face & left arm).  2nd Day:  Flu like symptoms (chills/fever -> 100.2 degrees).  3rd Day:  Severe headache (front of head/right side of head/back of neck).  4th Day:  Flu symptoms and headache gone.  However, left with vertigo type feeling, disorientation, memory loss, speech impaired, anxiety attacks, loss of appetite, liver discomfort.  5th -> 10 Day:  Still have vertigo type feeling, disorientation, memory loss, speech impaired, anxiety attacks, loss of appetite, liver discomfort.  Please send me a copy of the form you submit to the CDC.  Thank you.
Age: 53.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Speech disorder, Vertigo
Clinical narrative: 1st Day: Stroke like symptoms (numbness left side of face & left arm).  2nd Day:  Flu like symptoms (chills/fever -> 100.2 degrees).  3rd Day:  Severe headache (front of head/right side of head/back of neck).  4th Day:  Flu symptoms and headache gone.  However, left with vertigo type feeling, disorientation, memory loss, speech impaired, anxiety attacks, loss of appetite, liver discomfort.  5th -> 10 Day:  Still have vertigo type feeling, disorientation, memory loss, speech impaired, anxiety attacks, loss of appetite, liver discomfort.  Please send me a copy of the form you submit to the CDC.  Thank you.
Age: 30.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Diarrhoea, Eye pruritus, Flushing, Urticaria
Clinical narrative: Itchy eyes, hives all over body, flushed, diarrhea.
Age: 48.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Blood test normal, Cardiac stress test normal, Ocular hyperaemia, Pain in extremity, Paraesthesia
Clinical narrative: PAIN IN LEFT ARM IS VERY EXCRUTIONATING,TINGLING SENSATIONS,SPOTS APPEARED ON LEFT ARM. LEFT EYE WAS BLOODSHOT AND BLURINESS OCCURRED.
Age: 48.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Skin discolouration, Vision blurred
Clinical narrative: PAIN IN LEFT ARM IS VERY EXCRUTIONATING,TINGLING SENSATIONS,SPOTS APPEARED ON LEFT ARM. LEFT EYE WAS BLOODSHOT AND BLURINESS OCCURRED.
Age: 10.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: CSF protein increased, CSF white blood cell count increased, Diplegia, Hypotension, Muscular weakness
Clinical narrative: Transverse Myelitis
Age: 10.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Myelitis transverse, Neurogenic bladder, Neurogenic bowel, Pyrexia, Quadriplegia
Clinical narrative: Transverse Myelitis
Age: 10.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Sensory loss
Clinical narrative: Transverse Myelitis
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Caesarean section, Cholecystectomy, Cholelithiasis, Drug exposure during pregnancy
Clinical narrative: Information has been received from a registered nurse, for the Pregnancy Registry for GARDASIL, concerning a 27 year old female with PENICILLIN allergy and no other medical history who was intramuscularly vaccinated with the first and second 0.5 ml doses of GARDASIL on 14-July-2008 and 15-Sep-2008 (1st lot #660557/0072X) 2nd lot #659184/0843X), respectively. Concomitant therapy included diphtheria toxoid/tetanus toxoid which was vaccinated with the first dose of GARDASIL. Subsequently the patient became pregnant after receiving GARDASIL. The due date of pregnant gestation reported as 13-May-2009. No adverse effect reported. Laboratory diagnostic studies included prenatal blood tests. The patient sought unspecified medical attention. Follow up information was received from the registered nurse who reported that the patient had a history of irregular periods and she had reported that she was not pregnant at the time of her vaccination with GARDASIL in September 2008. The reporter administered the vaccine to the patient and estimated that the patient was approximately 5 weeks pregnant at the time of vaccination. On 30-Apr-2009 this patient delivered her baby by c-section following spontaneous rupture of membranes. Amniotic fluids were clear. Patient was GBS negative. Gestational age was 38  weeks +. It was also reported that the patient experienced cholelithiasis during pregnancy on 23-Mar-2009 and underwent a cholecystectomy on 27-May-2009. Upon internal review, c-section following spontaneous rupture of membranes was considered to be an other important medical event. The baby's experience has been captured WAES # 0901USA00343B1. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Streptococcal identification test negative
Clinical narrative: Information has been received from a registered nurse, for the Pregnancy Registry for GARDASIL, concerning a 27 year old female with PENICILLIN allergy and no other medical history who was intramuscularly vaccinated with the first and second 0.5 ml doses of GARDASIL on 14-July-2008 and 15-Sep-2008 (1st lot #660557/0072X) 2nd lot #659184/0843X), respectively. Concomitant therapy included diphtheria toxoid/tetanus toxoid which was vaccinated with the first dose of GARDASIL. Subsequently the patient became pregnant after receiving GARDASIL. The due date of pregnant gestation reported as 13-May-2009. No adverse effect reported. Laboratory diagnostic studies included prenatal blood tests. The patient sought unspecified medical attention. Follow up information was received from the registered nurse who reported that the patient had a history of irregular periods and she had reported that she was not pregnant at the time of her vaccination with GARDASIL in September 2008. The reporter administered the vaccine to the patient and estimated that the patient was approximately 5 weeks pregnant at the time of vaccination. On 30-Apr-2009 this patient delivered her baby by c-section following spontaneous rupture of membranes. Amniotic fluids were clear. Patient was GBS negative. Gestational age was 38  weeks +. It was also reported that the patient experienced cholelithiasis during pregnancy on 23-Mar-2009 and underwent a cholecystectomy on 27-May-2009. Upon internal review, c-section following spontaneous rupture of membranes was considered to be an other important medical event. The baby's experience has been captured WAES # 0901USA00343B1. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: FLU(H1N1), TDAP
Symptoms: Eyelid disorder, Facial palsy
Clinical narrative: Facial droop on right side.  Unable to close eyelid.  Patient seen at ER, then came to clinic 2 days later (on 12/14/09).
Age: 38.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Fatigue, Injection site pain, Myalgia
Clinical narrative: Soreness at injection site, then later that evening muscle aches and fatigue.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Musculoskeletal pain, Rheumatoid arthritis, Rheumatoid factor positive
Clinical narrative: Pain in shoulders mostly and other joints, knees, feet, elbows, jaw.
Age: 0.7
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Neonatal disorder
Clinical narrative: Information has been received from a registered nurse concerning a male baby whose mother was vaccinated with two doses of GARDASIL on 14-JUL-2008 and 15-SEP-2008 and was pregnant. On 30-APR-2009, the infant was born with problems. He had no respiratory effort at birth and required mechanical ventilation at a couple hours of life. The infant was admitted to a neonatal intensive care unit (NICU), then was transferred to another neonatal intensive care unit (NICU) and again transferred to another neonatal intensive care unit (NICU) for additional work-up on 05-MAY-2009, a pulmonologist performed a flexible bronchoscopy on the baby which showed mild laryngomalacia with normal vocal cord function. On 31-JUL-2009, the infant had suspected pneumonia, respiratory syncytial virus (RSV) was negative, influenza was negative. Respiratory cultures were positive for Ecoli. The infant alternated between being stable on room air and requiring respiratory assistant by bi-pap or nasal cannula through August 2009, remaining in the neonatal intensive care unit. In September 2009, the baby had suspected aspiration pneumonia with migrating infiltrates on chest x-ray. The baby was ultimately diagnosed with low respiratory muscle tone, respiratory failure and congenital myopathy. The baby had been referred to a children services at this time. The mother's experienced has been captured in WAES #0901USA00343. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Grand mal convulsion, Syncope
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with the first dose of GARDASIL vaccine (lot#, route and site of administration not reported). Subsequently, the patient has a syncopal episode. At the time of this report, the patient's outcome was unknown. Follow up information has been received from a physician concerning a 16 year old female patient with no other relevant medical histories who on 09-DEC-2009, at 11:30, was vaccinated with the second dose of GARDASIL vaccine (lot#665547/1318Y) into the left arm, a second dose of VARIVAX vaccine (Oka/Merck) (lot# 665040/1086Y) into the right arm and a second dose of ADACEL (lot# UF460CA) into the right arm. On 09-DEC-2009 the patient developed syncope and a brief tonic clonic seizure that lasted 5-10 seconds. The patient was having her annual physical examination at time of vaccination. No medical attention was sought. There were no laboratory diagnostics studies performed. On 09-DEC-2009 the patient recovered. Upon internal review, tonic clonic seizure was considered to be an other important medical event. This is one of several reports from the same source. Additional information is not expected.
Age: 26.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Dry eye, Hypoaesthesia, Hypoaesthesia facial, Muscular weakness, Paraesthesia
Clinical narrative: no PMH presents with 2 days of progressive R  facial numbness, tingling, and weakness and N/T in R arm for 2 days.  Denies pain or loss of sensation.  R eye not blinking well, and increased R  eye dryness.  This is the first time this has happened.  Denies fever,  recent illness, HA, N/V/D/C, dysphagia, loss of bladder or bowel fxn, loss  of coordination, or change in mentation.  No change in hearing, visual  acuity or sense of taste. No sick contacts. No oral contraceptive use.
Age: 3.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Abdominal pain, Blood amylase increased, Vomiting
Clinical narrative: Started with vomiting and abdomen pain. Taken to hospital and admitted on 12/11/09 with diagnosis of pancreatitis of unknown etiology and dischaged 12/15/09 without problems.
Age: 25.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Chills, Cough, Dizziness, Headache, Insomnia
Clinical narrative: High fever, severe chills, severe cough, runny nose, severe body aches, dizziness, lightheadedness, headache, night sweats, insomnia, sinus congestion.
Age: 25.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Night sweats, Pain, Pyrexia, Rhinorrhoea, Sinus congestion
Clinical narrative: High fever, severe chills, severe cough, runny nose, severe body aches, dizziness, lightheadedness, headache, night sweats, insomnia, sinus congestion.
Age: 53.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Back pain, Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: FEVERISH,CHILDS,PANTING,SORE MUSSLE, BACK ACHE,GETTING TIRED EASY.IT HAS BEEN
Age: 5.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Pyrexia
Clinical narrative: High fever upto 104 F with any other synonyms
Age: 60.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Hives over legs, abdomen, and arms Treated with 50mg Benedryl which controlled rash and itching. Hives retuned the following morning, evening,and next day. Continue to treat with Benedryl.
Age: 3.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Corneal reflex decreased, Tic
Clinical narrative: Strong blinking(a tick) noticed after shot
Age: 93.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: c/o nausea and vomiting 0922 on 12/24/09.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Diarrhoea, Nausea, Vomiting
Clinical narrative: Employee had a reaction possibly with nausea, vomiting, diarrhea & small amount of tightness in chest. Works in health care area in housekeeping. Employee has had problems with egg-based vaccine in past.
Age: 11.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Body temperature increased, Cough, Oropharyngeal pain, Pain
Clinical narrative: Mom reports 12/15/09 patient deveoped cough, body aches, sore throat ~ 48hrs after receiving H1N1 vaccine 11/19/09 at school-based clinic set up. Temp ~ 103 noted Sun. 11/22/09. Recovered fully at time of report.
Age: 1.68
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient vaccinated with preservative free H1N1 formulation intended for ages 36 months and older.
Age: 13.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Balance disorder, Gait disturbance
Clinical narrative: Initial report received on 17 December 2009 from a health care professional. A 13 year old male patient developed an awkward gait and was "off balance" the evening after he received Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative on 15 December 2009 (manufacturer was thought to be sanofi pasteur, lot not reported). The patient's mother called their physician to report these symptoms. The patient was seen by the physician on 17 December 2009. It was noted that the patient did not have any neurological deficits. Recovery status was unknown. List of Documents held by Sender: none.
Age: 21.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Gastrooesophageal reflux disease, Muscle tightness, Paraesthesia, Swelling, Upper respiratory tract infection
Clinical narrative: Initial report received on 18 December 2009 from a consumer who is also a health care professional. A 21 year old female patient with a history of asthma, food, and environmental allergies (concomitant therapy included Albuterol and ASMANEX) complained of an upper respiratory infection 1-2 days later and severe gastroesophageal reflux disease an unspecified amount of time after she received Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number UP006AA) on 04 November 2009. The patient was seen in the emergency room and was started on ZANTAC and PRILOSEC on an unspecified date. A few days later, during the morning hours of 15 November 2009 or 16 November 2009, she started developing tingling and swelling, also described as a "tight feeling", in her extremities. The symptoms have been getting worse with episodes throughout the day and night. According to the patient, these symptoms were worse in her feet than in her arms. The patient was scheduled for a visit with the neurologist on 21 December 2009. The patient was not recovered at the time of the report. List of Documents held by Sender: none.
Age: 2.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Oedema mouth, Pruritus, Swelling face
Clinical narrative: Initial report received 18 December 2009 from a health care professional. A two-year-old female patient with no known allergies had received a second dose intramuscular right thigh injection of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative, lot number UP019AA on 17 December 2009 and within 15 minutes of vaccination, she developed itchy hands and hive like swelling around her mouth and on her chin with no respiratory distress. The patient was sent to the emergency room and received corrective treatment with an Epipen and BENADRYL. A few hours after release, the symptoms restarted and the patient returned to the emergency room. The patient was admitted and remained hospitalized at the time of the report. At the time of vaccination, the patient had no concurrent illness, no medical conditions, and she had not been taking any concomitant medications. The patient had previously received a first dose intramuscular left thigh injection of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative, lot number UP019AA on 11 November 2009. She had no reported adverse events following prior vaccinations. At the time of the report, the patient had not recovered. Documents held by sender: None.
Age: 3.0
Sex: M
Vaccine: HIBV
Symptoms: Blood culture positive, Computerised tomogram abnormal, Culture throat negative, Device leakage, Drooling
Clinical narrative: This case was retrieved via a search of the scientific literature on 19 December 2009. A 3-year-old male patient had received a dose of HIB vaccine. The date of vaccination, trade name, manufacturer name, lot number, route and site of administration was not reported. The patient, who was fully immunized and otherwise healthy presented to an outside facility with a sore throat and fever. He developed sore throat and temperature of about 103.0 Degrees Fahrenheit abruptly 4 hours prior to arrival. He had mild symptoms of clear rhinorrhea and nasal congestion for two days prior to presentation. The patient had no cough, stridor, trismus, neck stiffness, nausea, vomiting, diarrhea, or rash. Physical examination initially demonstrated mild trismus and pharyngeal erythema. After 2 hours at the outside facility, he developed drooling and a muffled voice. A complete blood count showed a white blood cell count of 12.4 with 74 percent segmented neutrophils, and a blood culture was sent. A nasopharyngeal swab was positive for respiratory syncytial virus (RSV) but negative for influenza A and B. Monospot, rapid strep, and throat culture were all negative. He was initially in no respiratory distress, so a soft tissue neck film and a CT neck without contrast were obtained. The soft tissue neck film showed mild thickening of the epiglottis and aryepiglottic folds, and this was confirmed on CT. During the next three hours, the patient developed worsening odynophagia, inspiratory stridor, and wheezing. He was treated with Solumedrol, nebulized albuterol, racemic epinephrine, and ceftriaxone, with minimal improvement in his stridor and was in a modified sniffing position. He was taken immediately to the operating room. During induction of general anesthesia, he had moderate airway obstruction. Direct laryngoscope revealed a beefy, red epiglottis. He was subsequently intubated without difficult, and a swab culture was obtained from the epiglottis. The patient remained intubated for the next 40 hours, while receiving ampicillin/sulbactam and vancomycin. On hospital day 2, he received intravenous dexamethasone. On hospital day 3, he developed an air leak around his endotracheal tube and was successfully extubated. Blood cultures grew nontypeable H. influenzae biotype I. The culture from the epiglottis grew normal oral flora. Antibiotic coverage was narrowed to only ampicillin/sulbactam. The patient's clinical status rapidly improved, and he was discharged on hospital day 6. Documents held by sender: None.
Age: 3.0
Sex: M
Vaccine: HIBV
Symptoms: Dysphonia, Endotracheal intubation, Epiglottitis, Full blood count abnormal, Haemophilus infection
Clinical narrative: This case was retrieved via a search of the scientific literature on 19 December 2009. A 3-year-old male patient had received a dose of HIB vaccine. The date of vaccination, trade name, manufacturer name, lot number, route and site of administration was not reported. The patient, who was fully immunized and otherwise healthy presented to an outside facility with a sore throat and fever. He developed sore throat and temperature of about 103.0 Degrees Fahrenheit abruptly 4 hours prior to arrival. He had mild symptoms of clear rhinorrhea and nasal congestion for two days prior to presentation. The patient had no cough, stridor, trismus, neck stiffness, nausea, vomiting, diarrhea, or rash. Physical examination initially demonstrated mild trismus and pharyngeal erythema. After 2 hours at the outside facility, he developed drooling and a muffled voice. A complete blood count showed a white blood cell count of 12.4 with 74 percent segmented neutrophils, and a blood culture was sent. A nasopharyngeal swab was positive for respiratory syncytial virus (RSV) but negative for influenza A and B. Monospot, rapid strep, and throat culture were all negative. He was initially in no respiratory distress, so a soft tissue neck film and a CT neck without contrast were obtained. The soft tissue neck film showed mild thickening of the epiglottis and aryepiglottic folds, and this was confirmed on CT. During the next three hours, the patient developed worsening odynophagia, inspiratory stridor, and wheezing. He was treated with Solumedrol, nebulized albuterol, racemic epinephrine, and ceftriaxone, with minimal improvement in his stridor and was in a modified sniffing position. He was taken immediately to the operating room. During induction of general anesthesia, he had moderate airway obstruction. Direct laryngoscope revealed a beefy, red epiglottis. He was subsequently intubated without difficult, and a swab culture was obtained from the epiglottis. The patient remained intubated for the next 40 hours, while receiving ampicillin/sulbactam and vancomycin. On hospital day 2, he received intravenous dexamethasone. On hospital day 3, he developed an air leak around his endotracheal tube and was successfully extubated. Blood cultures grew nontypeable H. influenzae biotype I. The culture from the epiglottis grew normal oral flora. Antibiotic coverage was narrowed to only ampicillin/sulbactam. The patient's clinical status rapidly improved, and he was discharged on hospital day 6. Documents held by sender: None.
Age: 3.0
Sex: M
Vaccine: HIBV
Symptoms: Influenza serology negative, Laryngeal disorder, Laryngoscopy abnormal, Mononucleosis heterophile test negative, Nasal congestion
Clinical narrative: This case was retrieved via a search of the scientific literature on 19 December 2009. A 3-year-old male patient had received a dose of HIB vaccine. The date of vaccination, trade name, manufacturer name, lot number, route and site of administration was not reported. The patient, who was fully immunized and otherwise healthy presented to an outside facility with a sore throat and fever. He developed sore throat and temperature of about 103.0 Degrees Fahrenheit abruptly 4 hours prior to arrival. He had mild symptoms of clear rhinorrhea and nasal congestion for two days prior to presentation. The patient had no cough, stridor, trismus, neck stiffness, nausea, vomiting, diarrhea, or rash. Physical examination initially demonstrated mild trismus and pharyngeal erythema. After 2 hours at the outside facility, he developed drooling and a muffled voice. A complete blood count showed a white blood cell count of 12.4 with 74 percent segmented neutrophils, and a blood culture was sent. A nasopharyngeal swab was positive for respiratory syncytial virus (RSV) but negative for influenza A and B. Monospot, rapid strep, and throat culture were all negative. He was initially in no respiratory distress, so a soft tissue neck film and a CT neck without contrast were obtained. The soft tissue neck film showed mild thickening of the epiglottis and aryepiglottic folds, and this was confirmed on CT. During the next three hours, the patient developed worsening odynophagia, inspiratory stridor, and wheezing. He was treated with Solumedrol, nebulized albuterol, racemic epinephrine, and ceftriaxone, with minimal improvement in his stridor and was in a modified sniffing position. He was taken immediately to the operating room. During induction of general anesthesia, he had moderate airway obstruction. Direct laryngoscope revealed a beefy, red epiglottis. He was subsequently intubated without difficult, and a swab culture was obtained from the epiglottis. The patient remained intubated for the next 40 hours, while receiving ampicillin/sulbactam and vancomycin. On hospital day 2, he received intravenous dexamethasone. On hospital day 3, he developed an air leak around his endotracheal tube and was successfully extubated. Blood cultures grew nontypeable H. influenzae biotype I. The culture from the epiglottis grew normal oral flora. Antibiotic coverage was narrowed to only ampicillin/sulbactam. The patient's clinical status rapidly improved, and he was discharged on hospital day 6. Documents held by sender: None.
Age: 3.0
Sex: M
Vaccine: HIBV
Symptoms: Neutrophil percentage increased, Obstructive airways disorder, Odynophagia, Oropharyngeal pain, Pharyngeal erythema
Clinical narrative: This case was retrieved via a search of the scientific literature on 19 December 2009. A 3-year-old male patient had received a dose of HIB vaccine. The date of vaccination, trade name, manufacturer name, lot number, route and site of administration was not reported. The patient, who was fully immunized and otherwise healthy presented to an outside facility with a sore throat and fever. He developed sore throat and temperature of about 103.0 Degrees Fahrenheit abruptly 4 hours prior to arrival. He had mild symptoms of clear rhinorrhea and nasal congestion for two days prior to presentation. The patient had no cough, stridor, trismus, neck stiffness, nausea, vomiting, diarrhea, or rash. Physical examination initially demonstrated mild trismus and pharyngeal erythema. After 2 hours at the outside facility, he developed drooling and a muffled voice. A complete blood count showed a white blood cell count of 12.4 with 74 percent segmented neutrophils, and a blood culture was sent. A nasopharyngeal swab was positive for respiratory syncytial virus (RSV) but negative for influenza A and B. Monospot, rapid strep, and throat culture were all negative. He was initially in no respiratory distress, so a soft tissue neck film and a CT neck without contrast were obtained. The soft tissue neck film showed mild thickening of the epiglottis and aryepiglottic folds, and this was confirmed on CT. During the next three hours, the patient developed worsening odynophagia, inspiratory stridor, and wheezing. He was treated with Solumedrol, nebulized albuterol, racemic epinephrine, and ceftriaxone, with minimal improvement in his stridor and was in a modified sniffing position. He was taken immediately to the operating room. During induction of general anesthesia, he had moderate airway obstruction. Direct laryngoscope revealed a beefy, red epiglottis. He was subsequently intubated without difficult, and a swab culture was obtained from the epiglottis. The patient remained intubated for the next 40 hours, while receiving ampicillin/sulbactam and vancomycin. On hospital day 2, he received intravenous dexamethasone. On hospital day 3, he developed an air leak around his endotracheal tube and was successfully extubated. Blood cultures grew nontypeable H. influenzae biotype I. The culture from the epiglottis grew normal oral flora. Antibiotic coverage was narrowed to only ampicillin/sulbactam. The patient's clinical status rapidly improved, and he was discharged on hospital day 6. Documents held by sender: None.
Age: 3.0
Sex: M
Vaccine: HIBV
Symptoms: Pyrexia, Respiratory syncytial virus infection, Respiratory syncytial virus test positive, Rhinorrhoea, Streptococcal identification test negative
Clinical narrative: This case was retrieved via a search of the scientific literature on 19 December 2009. A 3-year-old male patient had received a dose of HIB vaccine. The date of vaccination, trade name, manufacturer name, lot number, route and site of administration was not reported. The patient, who was fully immunized and otherwise healthy presented to an outside facility with a sore throat and fever. He developed sore throat and temperature of about 103.0 Degrees Fahrenheit abruptly 4 hours prior to arrival. He had mild symptoms of clear rhinorrhea and nasal congestion for two days prior to presentation. The patient had no cough, stridor, trismus, neck stiffness, nausea, vomiting, diarrhea, or rash. Physical examination initially demonstrated mild trismus and pharyngeal erythema. After 2 hours at the outside facility, he developed drooling and a muffled voice. A complete blood count showed a white blood cell count of 12.4 with 74 percent segmented neutrophils, and a blood culture was sent. A nasopharyngeal swab was positive for respiratory syncytial virus (RSV) but negative for influenza A and B. Monospot, rapid strep, and throat culture were all negative. He was initially in no respiratory distress, so a soft tissue neck film and a CT neck without contrast were obtained. The soft tissue neck film showed mild thickening of the epiglottis and aryepiglottic folds, and this was confirmed on CT. During the next three hours, the patient developed worsening odynophagia, inspiratory stridor, and wheezing. He was treated with Solumedrol, nebulized albuterol, racemic epinephrine, and ceftriaxone, with minimal improvement in his stridor and was in a modified sniffing position. He was taken immediately to the operating room. During induction of general anesthesia, he had moderate airway obstruction. Direct laryngoscope revealed a beefy, red epiglottis. He was subsequently intubated without difficult, and a swab culture was obtained from the epiglottis. The patient remained intubated for the next 40 hours, while receiving ampicillin/sulbactam and vancomycin. On hospital day 2, he received intravenous dexamethasone. On hospital day 3, he developed an air leak around his endotracheal tube and was successfully extubated. Blood cultures grew nontypeable H. influenzae biotype I. The culture from the epiglottis grew normal oral flora. Antibiotic coverage was narrowed to only ampicillin/sulbactam. The patient's clinical status rapidly improved, and he was discharged on hospital day 6. Documents held by sender: None.
Age: 3.0
Sex: M
Vaccine: HIBV
Symptoms: Stridor, Trismus, Wheezing, White blood cell count increased, X-ray abnormal
Clinical narrative: This case was retrieved via a search of the scientific literature on 19 December 2009. A 3-year-old male patient had received a dose of HIB vaccine. The date of vaccination, trade name, manufacturer name, lot number, route and site of administration was not reported. The patient, who was fully immunized and otherwise healthy presented to an outside facility with a sore throat and fever. He developed sore throat and temperature of about 103.0 Degrees Fahrenheit abruptly 4 hours prior to arrival. He had mild symptoms of clear rhinorrhea and nasal congestion for two days prior to presentation. The patient had no cough, stridor, trismus, neck stiffness, nausea, vomiting, diarrhea, or rash. Physical examination initially demonstrated mild trismus and pharyngeal erythema. After 2 hours at the outside facility, he developed drooling and a muffled voice. A complete blood count showed a white blood cell count of 12.4 with 74 percent segmented neutrophils, and a blood culture was sent. A nasopharyngeal swab was positive for respiratory syncytial virus (RSV) but negative for influenza A and B. Monospot, rapid strep, and throat culture were all negative. He was initially in no respiratory distress, so a soft tissue neck film and a CT neck without contrast were obtained. The soft tissue neck film showed mild thickening of the epiglottis and aryepiglottic folds, and this was confirmed on CT. During the next three hours, the patient developed worsening odynophagia, inspiratory stridor, and wheezing. He was treated with Solumedrol, nebulized albuterol, racemic epinephrine, and ceftriaxone, with minimal improvement in his stridor and was in a modified sniffing position. He was taken immediately to the operating room. During induction of general anesthesia, he had moderate airway obstruction. Direct laryngoscope revealed a beefy, red epiglottis. He was subsequently intubated without difficult, and a swab culture was obtained from the epiglottis. The patient remained intubated for the next 40 hours, while receiving ampicillin/sulbactam and vancomycin. On hospital day 2, he received intravenous dexamethasone. On hospital day 3, he developed an air leak around his endotracheal tube and was successfully extubated. Blood cultures grew nontypeable H. influenzae biotype I. The culture from the epiglottis grew normal oral flora. Antibiotic coverage was narrowed to only ampicillin/sulbactam. The patient's clinical status rapidly improved, and he was discharged on hospital day 6. Documents held by sender: None.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Contusion, Henoch-Schonlein purpura
Clinical narrative: This case was considered medically important. Information regarding PREVNAR was received from a healthcare professional regarding a 6-month-old male patient who experienced unexplained bruising on forearms and legs and Henoch Schonlein purpura. The patient received a dose on 08-Dec-2009. The patient also received a dose of ENGERIX B (Smith Kline & French Laboratories) and a dose of PENTACEL (Aventis-Pasteur) on 08-Dec-2009. On 10-Dec-2009, 2 days after vaccination, the patient experienced Henoch Schonlein purpura and unexplained bruising on his forearms and legs. At the time of this reporting, the Henoch-Schonlein purpura was unresolved and the outcome of the contusion was not specified. The reporter considered the Henoch-Schonlein purpura to be possibly related to PREVNAR, ENGERIX B and PENTACEL. No additional information was available at the time of this report.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Echocardiogram
Clinical narrative: Information has been received from a physician concerning a 24 year old female patient with no known drug allergies or pertinent medical history who on 12-DEC-2008 was vaccinated with the first dose of GARDASIL (Lot number 661764/0650X). Concomitant therapy included birth control pills. The patient developed SBT (Supra Ventricular Tachycardia) and she was hospitalized. The patient could not remember the exact date of her hospital confinement when she reported the event to the physician she thought it to be two weeks after the vaccination. The patient told her physician she underwent an electrocardiogram (EKG), echocardiogram (ECHO) and exam with no results provided to the reporting physician. No surgery was performed. On an unspecified date the patient was discharged from cardiologist's care. The patient will not receive further doses of GARDASIL as the patient believed the event was caused by the vaccine. The physician reported that there was no association between SVT and GARDASIL. At the time of the report the patient had recovered. "Supra Ventricular Tachycardia" was considered by the physician to be life-threatening. No further information is available.
Sex: U
Vaccine: RV5
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning her child who in 2007 was vaccinated with a dose of ROTATEQ (Lot # 654423/0940F). The mother reported that her child was diagnosed with autism. The consumer stated that she "is not saying that ROTATEQ caused the autism". It was unknown if the patient sought medical attention. At the time of this report, the patient's outcome was unknown. Upon internal review, autism was determined to be an other important medical event. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: MMR
Symptoms: Autism, Speech disorder developmental
Clinical narrative: Information has been received from author of a published article titled as above, concerning a 2 year old patient with a history of umbilical cord compression (emergency cesarean section was performed) and resuscitation at birth, who on 05-FEB-2003 and 25-MAY-2006 was vaccinated with a first and second dose of MMR II. In approximately 2004 the patient developed delayed speech. The author commented as follows: "we do not look forward as if on the date the patient's documented speech delay to decide whether his condition necessarily would result in autism. We know that delayed speech does not invariably presage and autistic disorder, but that is not the proper focus inquiry. Instead, we look back from the date the petition was filed to determine, as a historical matter, when the symptoms of the autism that we know will eventually be diagnosed were established in the record. The statute of limitations begins to run from the date that the symptoms of autism appeared that would generally be recognized in the medical community". Upon internal review it was determined that autism was considered to be an other important medical event. At the time of the report the patient had not recovered. No further information is available. A copy of the published article is attached as further documentation of the patient's experience.
Age: 41.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dysphagia, Feeling hot, Hearing impaired, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: Initial report received from the Health authority (MHRA-ADR-20535038-001) on 09 Dec 2009: This patient with medical history of asthma was vaccinated by Influenza (H1N1 influenza virus vaccine) (batch E9698-2), split virion inactivated on 30 Oct 2009. The patient experienced swollen tongue, swollen glands, felt warm had an inability to swallow, sore throat and her hearing was affected on 31 Oct 2009. The patient was seen by the doctor and was prescribed 5 mg of an unspecified steroid daily for one week. The outcome was reported to be completely recovered. The reporter assessed the case as serious.
Age: 41.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Swollen tongue
Clinical narrative: Initial report received from the Health authority (MHRA-ADR-20535038-001) on 09 Dec 2009: This patient with medical history of asthma was vaccinated by Influenza (H1N1 influenza virus vaccine) (batch E9698-2), split virion inactivated on 30 Oct 2009. The patient experienced swollen tongue, swollen glands, felt warm had an inability to swallow, sore throat and her hearing was affected on 31 Oct 2009. The patient was seen by the doctor and was prescribed 5 mg of an unspecified steroid daily for one week. The outcome was reported to be completely recovered. The reporter assessed the case as serious.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Cough, Hyperhidrosis, Nasopharyngitis, Oropharyngeal pain, Pyrexia
Clinical narrative: Cold, cough, next day had a fever of 102, runny nose, coughing, cold.  A week later still had chronic cough, low grade fever, throat starting feeling sore, sweats, lost my voice. Received an antobotic on 12/22/2009 from doctor along with cough syrup. 12/24/2009 still having sweats, lost voice, and still coughing, blowing my nose.  Whatever this is is not letting go. Missing out on all holiday celebration, as people don't want to be around sick people.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Rhinorrhoea
Clinical narrative: Cold, cough, next day had a fever of 102, runny nose, coughing, cold.  A week later still had chronic cough, low grade fever, throat starting feeling sore, sweats, lost my voice. Received an antobotic on 12/22/2009 from doctor along with cough syrup. 12/24/2009 still having sweats, lost voice, and still coughing, blowing my nose.  Whatever this is is not letting go. Missing out on all holiday celebration, as people don't want to be around sick people.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This 14 year old female patient received varicella virus vaccine 0.5mL subcutaneously in the right arm on 18Nov2009 as a part of a routine physical. The patient&#8217;s relevant medical history includes no previous adverse reactions to varicella virus vaccination. The patient&#8217;s relevant concomitant medications and past drug history are unknown. On 19Nov2009, this patient returned to a clinic for an appointment with a pediatrician. She presented with redness, swelling, and warmth to the injection site. No additional laboratory testing was required and no rescue drugs were used due to her symptoms. The outcome of the event is unknown.
Age: 6.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Urticaria
Clinical narrative: This nurse reports that this 6 year old male consumer received H1N1 vaccine, 0.5mL, at a public health clinic on 08Nov2009.The patient&#8217;s relevant medical history includes no previous allergic reactions to H1N1 vaccine or seasonal flu vaccines; no allergy to eggs; he has a history of asthma.  On 08Nov2009, within 30 minutes after the immunization, he broke out in hives and continued to have hives off and on for two weeks. The child did not require any additional laboratory testing or any additional medications. The mother of the child refused further immunization with N1H1 vaccine. It is unknown if the child continues to experience hives.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Injection site mass, Injection site pain, Injection site swelling, Injection site warmth, Mobility decreased
Clinical narrative: On 24Nov2009, this 44 year old female patient received 0.5mL of pneumococcal vaccine, intramuscularly, in her left arm. The patient&#8217;s relevant medical history includes no previous allergic reaction to the pneumococcal vaccine. On 26Nov2009, a lump developed at injection site. The lump was sore to touch and it was hard to move the left arm for a few days after the lump developed per the patient&#8217;s report.  On 09Dec2009, the lump is approximately 3.5cm x 2cm; no redness and no streaking; the lump is slightly warm and tender to touch. The patient was viewed by a doctor. It was recommended that the patient use ice and call if swelling becomes worse or redness develops. It is unknown if the patient continues pneumococcal vaccine and it is unknown if she continues to experience a lump at the injection site.
Age: 23.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Cough, Dizziness, Dysphonia, Feeling cold, Hot flush
Clinical narrative: symptoms began with a fever in the early mornings hours, followed by coughing, hot/cold flashes, dizzyness, hoarseness of voice. Symptoms led me to leave work early, see my primary care doctor who told me to take flu medication and return to the hospital if my symptoms became worse.  I will return to my doctors office as soon as they are open again as my symptoms are not improving.
Age: 23.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Pyrexia
Clinical narrative: symptoms began with a fever in the early mornings hours, followed by coughing, hot/cold flashes, dizzyness, hoarseness of voice. Symptoms led me to leave work early, see my primary care doctor who told me to take flu medication and return to the hospital if my symptoms became worse.  I will return to my doctors office as soon as they are open again as my symptoms are not improving.
Age: 32.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Dizziness, Fatigue, Oropharyngeal pain, Rhinorrhoea, Sinus congestion
Clinical narrative: Brief dizzy spell, extreme tiredness.  I went home and slept from 6pm to the next day. Next day I had a sore throat and runny nose and still felt very tired. Day 3 I began to feel better.  Day 4 (today) December 25, remission back to feeling worse. Sore throat, stuffy head, tired etc....
Age: 53.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: hives on legs, abdomen, arms, face, back. day 2 - hives have grown into almost solid red on legs, back. took benedryl Dec 24 pm. No other known/suspected cause of hives. No other known allergies. only mild itching.
Age: 28.0
Sex: M
Vaccine: FLUX, HEPA, TDAP, TYP
Symptoms: Headache
Clinical narrative: developed mild to moderate headaches, took Tylenol for 2 days, then recovered
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Dysstasia, Lumbar puncture, Muscular weakness, Nerve conduction studies, Paraesthesia
Clinical narrative: gradual onset of paresthesias in both feet, both hands progressing to weakness in both legs with inability to stand over a course of 4 days. needed treatment by intravenous gamma globulin for 5 days.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Scan brain
Clinical narrative: gradual onset of paresthesias in both feet, both hands progressing to weakness in both legs with inability to stand over a course of 4 days. needed treatment by intravenous gamma globulin for 5 days.
Age: 0.83
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Rash, Swelling, Urticaria
Clinical narrative: 2 x hives on left leg first noticed at night on Saturday. Unsure when first appeared. Hives now on left (2) and right leg (1), also on arm (1). Rash on upper shoulder and back has now resolved without treatment. Rash in pubic area, has now resolved without treatment. Had swelling under right eye and cheek, now resolved without treatment.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed, Pregnancy test negative
Clinical narrative: Menstrual bleeding(period) has been delayed for 15 days. No bleeding as of this day. Pregnancy blood test is negative.
Age: 7.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Fatigue, Oropharyngeal pain, Pyrexia
Clinical narrative: dizziness,fatique, fever 104F lasted 2 days. Treated with ibuprofen/acetamenaphen Also had sore throat
Age: 31.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Crohn's disease, Intestinal fistula, Laboratory test abnormal, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Crohn's Disease flare -- after 13 years of remission.
Age: 33.0
Sex: M
Vaccine: TYP, YF
Symptoms: Chills, Injection site urticaria, Pyrexia
Clinical narrative: Intermittent fever, chills, prolonged hives at site of vaccination.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dysmenorrhoea
Clinical narrative: Soon after receiving the Gardasil Vaccine I began experiencing menstrual cramps.  They were sporadic and light the first day.  By 12/25/09 they had gotten much worse and I began my period.  My menstrual cycle is very regular and occurs in the first week of every month.
Age: 38.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Chills, Cough, Fatigue, Increased upper airway secretion, Malaise
Clinical narrative: Runny & Stuffy nose, chills,fatigue, coughing w/ phlegm  production, general malaise, feeling like I was coming down w/ "something bad"
Age: 38.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Nasal congestion, Rhinorrhoea
Clinical narrative: Runny & Stuffy nose, chills,fatigue, coughing w/ phlegm  production, general malaise, feeling like I was coming down w/ "something bad"