chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Dizziness, Dyspnoea, Erythema, Malaise, Nausea
Clinical narrative: Pt came back @ 11:40 am after flu vaccination with c/o "lightheadedness and sick to stomach". After 35 minutes pt had red, splotchy spots on chest and red ears. No itching, no wheezes, at 1:01 pm, pt c/o difficulty taking deep breath. O2 24 min per NC applied. Pt sent to ER via EMS with mom accompanying her. 12/15/09: 5:05 pm spoke to family member stated pt doing better and is on her way home from ER.
Age: 18.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Rash papular
Clinical narrative: Pt came back @ 11:40 am after flu vaccination with c/o "lightheadedness and sick to stomach". After 35 minutes pt had red, splotchy spots on chest and red ears. No itching, no wheezes, at 1:01 pm, pt c/o difficulty taking deep breath. O2 24 min per NC applied. Pt sent to ER via EMS with mom accompanying her. 12/15/09: 5:05 pm spoke to family member stated pt doing better and is on her way home from ER.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Inflammation, Lymph node pain, Lymphadenopathy, Mononeuritis
Clinical narrative: Inflammation left axilla; headache; twitching left side of face. large tender axillary lymph node assessed and Dx Cranial mono neuritis and reactive lymphadenopathy secondary pertussis vaccination. No treatment. 1/14/10 follow-up - no numbness, lymph node imp
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Muscle twitching, Pertussis
Clinical narrative: Inflammation left axilla; headache; twitching left side of face. large tender axillary lymph node assessed and Dx Cranial mono neuritis and reactive lymphadenopathy secondary pertussis vaccination. No treatment. 1/14/10 follow-up - no numbness, lymph node imp
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Vomiting
Clinical narrative: Received shot 1.11.10 @ 4pm and reported fever (103.2) and vomiting at about 9pm. Message taken at 9a 1.12.10
Age: 57.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Arthralgia, Impaired work ability, Swelling
Clinical narrative: Flare episode: swelling and joint pain, unable to return to work after receiving H1N1 vaccination
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Dysphagia, Oropharyngeal pain, Pruritus, Rash erythematous
Clinical narrative: broke out in systemic red raised itchy rash, c/o sore throat with difficulty swallowing
Age: 2.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Blood test, Influenza serology negative, Pneumonia, Pyrexia, Respiratory syncytial virus test
Clinical narrative: Kid had 1st dose of H1N1Mist on 11/28/09, had 2nd dose H1N1 shot on 1/11/2010, developed fever on 1/12/10 night, came to Clinic on 1/13/10 for fever 104. Kid was tachycardia, tachypnea, temp 99 axillary, sent kid to ED for evaluation. In ED, kid was tested with nonremarkable blood work result, negative Flu, mild pneumonia. Kid was diagnosed with RSV and pneumonia, with IV fluid and Amoxicillin treatment and discharged home on the same day. The ED doctor thought it was not related to vaccine. Follow up call, Kid is feeling much better today.
Age: 2.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Tachycardia, Tachypnoea
Clinical narrative: Kid had 1st dose of H1N1Mist on 11/28/09, had 2nd dose H1N1 shot on 1/11/2010, developed fever on 1/12/10 night, came to Clinic on 1/13/10 for fever 104. Kid was tachycardia, tachypnea, temp 99 axillary, sent kid to ED for evaluation. In ED, kid was tested with nonremarkable blood work result, negative Flu, mild pneumonia. Kid was diagnosed with RSV and pneumonia, with IV fluid and Amoxicillin treatment and discharged home on the same day. The ED doctor thought it was not related to vaccine. Follow up call, Kid is feeling much better today.
Age: 1.5
Sex: F
Vaccine: DTAP, FLU(H1N1), HEPA, IPV
Symptoms: Computerised tomogram, Fall, Grand mal convulsion, Musculoskeletal stiffness, Nuclear magnetic resonance imaging brain
Clinical narrative: Generalized seizure. Fell after eating. Stiff, staring for 1-2 minutes.
Age: 1.5
Sex: F
Vaccine: DTAP, FLU(H1N1), HEPA, IPV
Symptoms: Staring
Clinical narrative: Generalized seizure. Fell after eating. Stiff, staring for 1-2 minutes.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort, Chills, Dyspnoea, Fatigue, Headache
Clinical narrative: Pt received seasonal flu shot at 3pm and around 6 pm, he started getting chills, began feeling fatigued and not well. He left work early. Developed headache, muscle aches, a fever (100.8), stronger chills, red eyes and intense fatigue. Heart was racing, labored breathing and stomach felt sick.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Myalgia, Ocular hyperaemia, Palpitations, Pyrexia
Clinical narrative: Pt received seasonal flu shot at 3pm and around 6 pm, he started getting chills, began feeling fatigued and not well. He left work early. Developed headache, muscle aches, a fever (100.8), stronger chills, red eyes and intense fatigue. Heart was racing, labored breathing and stomach felt sick.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: arm swollen, red, & hot to the touch
Age: 61.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Asthenia, Back pain, Constipation, Fatigue, Muscular weakness
Clinical narrative: Pt states that since receiving flu vaccine on 1/8/10, he has felt fatiqued, aching in neck and back.  Feels that he is weaker in leg and in back.  No fever no NVD. Has marked constipation, which he also dates to this.  He states he has marked decrease in strength in arms and legs.
Age: 61.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Neck pain
Clinical narrative: Pt states that since receiving flu vaccine on 1/8/10, he has felt fatiqued, aching in neck and back.  Feels that he is weaker in leg and in back.  No fever no NVD. Has marked constipation, which he also dates to this.  He states he has marked decrease in strength in arms and legs.
Age: 61.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Asthenia, Back pain, Constipation, Fatigue, Guillain-Barre syndrome
Clinical narrative: Pt states that since receiving flu vaccine on 1/8/10, he has felt fatiqued, aching in neck and back.  Feels that he is weaker in leg and in back.  No fever no NVD. Has marked constipation, which he also dates to this.  He states he has marked decrease in strength in arms and legs.
Age: 61.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Muscular weakness, Neck pain
Clinical narrative: Pt states that since receiving flu vaccine on 1/8/10, he has felt fatiqued, aching in neck and back.  Feels that he is weaker in leg and in back.  No fever no NVD. Has marked constipation, which he also dates to this.  He states he has marked decrease in strength in arms and legs.
Age: 6.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Rash generalised
Clinical narrative: Child received nasal spray vaccine in the afternoon at a school clinic. Her parent picked her up to take her home. When they arrived home they noticed child had a rash across nose, cheeks, and onto her neck. Parent gave the child Benadryl.
Age: 3.0
Sex: M
Vaccine: DTAP, FLU3, PNC
Symptoms: Computerised tomogram normal, Convulsion, Electroencephalogram abnormal, Gaze palsy, Metabolic function test normal
Clinical narrative: Pt sat up from sleep and was unresponsive.  Eyes rolled to the back of his head.  Left side of face was "twitching," as were left upper and lower extremities.  Seizure later generalized.  2mg Ativan was given IV by ambulance which did not break seizure.  Seizure finally broke 45 minutes after onset after loading dose of Cerebyx given.
Age: 3.0
Sex: M
Vaccine: DTAP, FLU3, PNC
Symptoms: Muscle twitching, Nuclear magnetic resonance imaging normal, Unresponsive to stimuli
Clinical narrative: Pt sat up from sleep and was unresponsive.  Eyes rolled to the back of his head.  Left side of face was "twitching," as were left upper and lower extremities.  Seizure later generalized.  2mg Ativan was given IV by ambulance which did not break seizure.  Seizure finally broke 45 minutes after onset after loading dose of Cerebyx given.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, RV5
Symptoms: Diarrhoea, Faeces discoloured, Haematochezia, Mucous stools, Skin test negative
Clinical narrative: Diarrhea got worse. Color changed from brown to green and was extremely watery and mucousy. Continuous diarrhea for over 2 months now. Some spots and streaks of blood in diarrhea being seen.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, RV5
Symptoms: Stool analysis normal
Clinical narrative: Diarrhea got worse. Color changed from brown to green and was extremely watery and mucousy. Continuous diarrhea for over 2 months now. Some spots and streaks of blood in diarrhea being seen.
Age: 23.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Pruritus
Clinical narrative: ITCHING
Age: 50.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Blood bicarbonate decreased, Blood creatinine increased, Blood potassium increased, Blood urea increased, Dialysis
Clinical narrative: malaise, body aches progressing to fulminant kidney failure as of today.  being dialyzed now.
Age: 50.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Malaise, Pain, Renal failure
Clinical narrative: malaise, body aches progressing to fulminant kidney failure as of today.  being dialyzed now.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Basophil count decreased, Basophil percentage, Blood culture negative, C-reactive protein increased, Chest pain
Clinical narrative: Large, red blotchy rash to face, neck, arms, chest and back. No shortness of breath, difficulty swallowing, chest pain or swelling. Patient instructed to go home and take Zyrtec. Rash resolved over next few hours. The patient was able to eat and went to bed at her usual time, but awoke at 1:00am on 1/12/10 with the acute chest pains that were sharp in nature, particularly on her left lateral side radiating into her left back and could not get comfortable.  These were associated with exacerbation with taking a deep breath.  The patient presented to the hospital.  Workup in the emergency room identified a significant leukocytosis.  A CT scan of the chest is equivocal because of low dye concentration in the arteries, but there is some question that she may have a pulmonary infarct versus infiltrates.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Computerised tomogram abnormal, Culture urine negative, Eosinophil count decreased, Eosinophil percentage, Haematocrit normal
Clinical narrative: Large, red blotchy rash to face, neck, arms, chest and back. No shortness of breath, difficulty swallowing, chest pain or swelling. Patient instructed to go home and take Zyrtec. Rash resolved over next few hours. The patient was able to eat and went to bed at her usual time, but awoke at 1:00am on 1/12/10 with the acute chest pains that were sharp in nature, particularly on her left lateral side radiating into her left back and could not get comfortable.  These were associated with exacerbation with taking a deep breath.  The patient presented to the hospital.  Workup in the emergency room identified a significant leukocytosis.  A CT scan of the chest is equivocal because of low dye concentration in the arteries, but there is some question that she may have a pulmonary infarct versus infiltrates.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Haemoglobin normal, Laboratory test normal, Leukocytosis, Lymphocyte count normal, Lymphocyte percentage decreased
Clinical narrative: Large, red blotchy rash to face, neck, arms, chest and back. No shortness of breath, difficulty swallowing, chest pain or swelling. Patient instructed to go home and take Zyrtec. Rash resolved over next few hours. The patient was able to eat and went to bed at her usual time, but awoke at 1:00am on 1/12/10 with the acute chest pains that were sharp in nature, particularly on her left lateral side radiating into her left back and could not get comfortable.  These were associated with exacerbation with taking a deep breath.  The patient presented to the hospital.  Workup in the emergency room identified a significant leukocytosis.  A CT scan of the chest is equivocal because of low dye concentration in the arteries, but there is some question that she may have a pulmonary infarct versus infiltrates.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Monocyte count normal, Monocyte percentage increased
Clinical narrative: Large, red blotchy rash to face, neck, arms, chest and back. No shortness of breath, difficulty swallowing, chest pain or swelling. Patient instructed to go home and take Zyrtec. Rash resolved over next few hours. The patient was able to eat and went to bed at her usual time, but awoke at 1:00am on 1/12/10 with the acute chest pains that were sharp in nature, particularly on her left lateral side radiating into her left back and could not get comfortable.  These were associated with exacerbation with taking a deep breath.  The patient presented to the hospital.  Workup in the emergency room identified a significant leukocytosis.  A CT scan of the chest is equivocal because of low dye concentration in the arteries, but there is some question that she may have a pulmonary infarct versus infiltrates.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Neutrophil count decreased, Neutrophil percentage increased, Platelet count normal, Prothrombin time normal, Rash erythematous
Clinical narrative: Large, red blotchy rash to face, neck, arms, chest and back. No shortness of breath, difficulty swallowing, chest pain or swelling. Patient instructed to go home and take Zyrtec. Rash resolved over next few hours. The patient was able to eat and went to bed at her usual time, but awoke at 1:00am on 1/12/10 with the acute chest pains that were sharp in nature, particularly on her left lateral side radiating into her left back and could not get comfortable.  These were associated with exacerbation with taking a deep breath.  The patient presented to the hospital.  Workup in the emergency room identified a significant leukocytosis.  A CT scan of the chest is equivocal because of low dye concentration in the arteries, but there is some question that she may have a pulmonary infarct versus infiltrates.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Rash macular, Red blood cell count normal, Red cell distribution width increased, Ultrasound scan normal, White blood cell count increased
Clinical narrative: Large, red blotchy rash to face, neck, arms, chest and back. No shortness of breath, difficulty swallowing, chest pain or swelling. Patient instructed to go home and take Zyrtec. Rash resolved over next few hours. The patient was able to eat and went to bed at her usual time, but awoke at 1:00am on 1/12/10 with the acute chest pains that were sharp in nature, particularly on her left lateral side radiating into her left back and could not get comfortable.  These were associated with exacerbation with taking a deep breath.  The patient presented to the hospital.  Workup in the emergency room identified a significant leukocytosis.  A CT scan of the chest is equivocal because of low dye concentration in the arteries, but there is some question that she may have a pulmonary infarct versus infiltrates.
Age: 34.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Cervical incompetence, Cough, Drug exposure during pregnancy, Intra-uterine death, Myalgia
Clinical narrative: Upon administration of vaccine, I had muscle ache then coughing.  Coughing continue despite of cough suppressant then 12/30/2009- I had premature labor due to cervical incompetence that lead to hospitalization of 4 days however my son died and was delivered 01/01/2010, age of 21 weeks.  I STRONGLY BELIEVE THAT H1N1 VACCINE TRIGGERED A LOT OF COMPLICATION TO MY HEALTH THAT LEAD TO CERVICAL INCOMPETENCE BECAUSE THE ONLY MEDICAL INTERVENTION THAT I HAD WAS THE VACCINE.  I HAD MY DAUGHTER, NORMALLY DELIVERED AND IN MY FAMILY, MY MEDICAL HISTORY, WE DON'T HAVE THIS KIND OF ILLNESS DURING PREGNANCY.
Age: 34.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Premature labour, White blood cell count increased
Clinical narrative: Upon administration of vaccine, I had muscle ache then coughing.  Coughing continue despite of cough suppressant then 12/30/2009- I had premature labor due to cervical incompetence that lead to hospitalization of 4 days however my son died and was delivered 01/01/2010, age of 21 weeks.  I STRONGLY BELIEVE THAT H1N1 VACCINE TRIGGERED A LOT OF COMPLICATION TO MY HEALTH THAT LEAD TO CERVICAL INCOMPETENCE BECAUSE THE ONLY MEDICAL INTERVENTION THAT I HAD WAS THE VACCINE.  I HAD MY DAUGHTER, NORMALLY DELIVERED AND IN MY FAMILY, MY MEDICAL HISTORY, WE DON'T HAVE THIS KIND OF ILLNESS DURING PREGNANCY.
Age: 1.72
Sex: F
Vaccine: FLU3
Symptoms: Electroencephalogram normal, Grand mal convulsion, Pyrexia
Clinical narrative: 20 mons. F with h/o complex febrile seizures x 4 in past who was admitted with generalized tonic - clonic seizure lasting longer than 30 mins., not breaking until DIASTAT and 5 doses of IV medication given. She had been febrile earlier in the evening to 101.4 then defervesced with TYLENOL, following which she went to sleep. She was not febrile (99.8 per mother) at time of seizure and acid timeline.
Age: 26.0
Sex: M
Vaccine: FLUN3
Symptoms: Pruritus, Swelling, Urticaria
Clinical narrative: On 20 October 2009, I received the Seasonal Flu Mist. Following it, I went into work. I experienced no symptoms until later in the evening. I went to bed approximately 1030pm. Soon after, my head and hands began to itch terribly. I took some Benadryl and it stopped the itching and I went to sleep. The next morning I woke up and had welts on my hands with itching. I put some cortisone ointment on them and he helped for a short period of time. Later that day, my unit had training in the same location that the mist was given. While at training, I reviewed the reactions part of the brochure that was given with the vaccine. Upon seeing that my reaction was similar, I immediately went to the individuals giving the vaccine.  They informed me to go the closest medical facility. I was given Benadryl and cortisone and sent home. The following morning, I awoke with hives all over my face and they continuously itched.  I called medical, and was informed to put cortisone on and to come in. The cortisone relieved the itching and helped with the swelling. This continued on and off for about 3 weeks. The symptoms finally went away.
Age: 35.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Chills, Pyrexia
Clinical narrative: Fever of 101 - chills - lasted two hours and completely resolved
Age: 86.0
Sex: M
Vaccine: FLU(H1N1), TTOX
Symptoms: Blood glucose, Tachycardia, Thyroid function test, Vision blurred
Clinical narrative: PATIENT WAS GIVEN H1N1, TETANUS AND B12 INJECTIONS AT CLINIC.  30 MINUTES AFTER, EXPERIENCED BLURRED VISION AND TACHYCARDIA WHILE DRIVING HOME.  STOPPED AT A LOCAL MED CTR AND WAS SENT TO A NEIGHBORING LARGER TOWN TO BE EXAMINED IN ER BY DOCTORS.  PATIENT WAS OBSERVED 2 HOURS AND RELEASED.
Age: 1.64
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting and diarrhoea for 3 hours.  No fever.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: 4-5 hrs after flu shot, pt started with a headache which progressed over time to a real head-in-a-vice splitting HA. Did not resolve with TYLENOL. 3 hrs of fever and body ache which resolved quickly. HA took about 24 hrs to go away.
Age: 9.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Idiopathic thrombocytopenic purpura, Platelet count decreased, Thrombocytopenia
Clinical narrative: Severe thrombocytopenia detected 1/12/10. Platelet 2,000. Diagnosis ITP.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Pain in extremity, Skin warm, Swelling
Clinical narrative: She was vaccinated with first dose of regular influenza vaccine shot (by IM inj on Right arm) on 10th January. Within 6 hours of vaccine shot, she had pain on that went toward the elbow, whole arm was sore, silver dollar size swelling. 1/4 inch width, warm to touch, lasted for about a week.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, FLUX(H1N1), HIBV, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: 103 fev after imm given that lasted off & on x 30 hours.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Dyspnoea, Pneumonia, Pyrexia
Clinical narrative: 5 year old female child received FLUMIST 10/6/09. She had history of pneumonia in infancy, but no other pre-existing medical conditions prior to vaccination. After a week, she developed fever, shortness of breath and a cough. Symptoms did not resolve after a few days, so sought medical care. Subject diagnosed with pneumonia per chest X-ray, treated with AUGMENTIN. Symptoms did not improve, subject desaturating in low 90s and antibiotic changed to ZITHROMAX. Symptoms improved in - 5 days. No further problems. Subject received seasonal flu IM in past without any issues. Mom doesn't think pneumonia is related to vaccine. No chronic conditions
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Monoplegia, Pain, Periarthritis
Clinical narrative: She experienced normal soreness the same day. The pain persisted and worsened until one week later when she could no longer lift her right arm over her head. She visited and orthopedist who diagnosed her with adhesive capsulitis ("frozen shoulder") that the doctor said can be caused  vaccine. The pain has continued but improved. On 10/29/09 she reported being about 90% recovered. Requested vaccine without thimerosal.
Age: 75.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Coagulopathy, Death, Drug interaction, International normalised ratio increased
Clinical narrative: Suspect H1N1 caused interaction with COUMADIN/coagulation.
Age: 5.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Urticaria
Clinical narrative: Patient was given the H1N1 nasal mist (1st dose) with no apparent adverse reactions. At 10pm @ home hives developed on Rt arm (3) L arm (2) L wrist (1). AM L forearm (1) and upper L eye brown (1). Seen by pediatrician, given BENADRYL on 1/13/10. 1/14/10 some fading of hives. Hives improving no new break out.
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: Asthenia, Chills, Dizziness, Epistaxis, Fatigue
Clinical narrative: Broke out in hives on Friday and gone by Monday. Bloody nose, weakness or tiredness, fatigue, chills, vertigo, dizziness.
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria, Vertigo
Clinical narrative: Broke out in hives on Friday and gone by Monday. Bloody nose, weakness or tiredness, fatigue, chills, vertigo, dizziness.
Age: 49.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Headache, Pyrexia
Clinical narrative: stomach cramping, diarrhea, low grade temperature, chills, headache
Age: 11.0
Sex: M
Vaccine: FLUN3
Symptoms: Erythema
Clinical narrative: Redness to face, chest and both arms approx.
Age: 57.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: After 3 days of vaccination, patient complained of generalized itching and has hives (red spots).
Age: 77.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Cough, Muscle tightness, Pain, Pain in extremity
Clinical narrative: Patient woke up in middle of night with severe legs pain (lower) and muscle tightness. Persisted for a couple of hours. Also experienced cough. Pt took IBUPJROFEN ate a banana and walked for awhile. Couldn't stand pain. Went to bed. Woke up fine in AM.
Age: 8.0
Sex: M
Vaccine: FLU(H1N1), HEPA
Symptoms: Rash, Urticaria
Clinical narrative: Patient given H1N1 and hives developed red blotchy rash.  to trunk, back and arms within seconds, no difficulty breathing, lungs CTA, 1 tsp BENADRYL given.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN3, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Developed moderate localized leg (thigh) swelling and redness in area of shots on left leg and thigh. 13 x 8 cm size.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness and swelling right deltoid only lasting 3 days, mild pain and itching at site of injection lasting one day. Advised Ibuprofen q 6-8 hrs prn, cold compress prn for swelling.
Age: 1.64
Sex: M
Vaccine: DTAP, FLU3, HIBV, MMR
Symptoms: Rash maculo-papular
Clinical narrative: Red maculopapular rashes form on face trunk, extremities BENADRYL 12.5/5 1 tsp 3 x a day.
Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Left deltoid area became reddened with a lump to greater than a quarter size. The pt did not seek medical care even though possible side effects and available resources were reviewed with her at the time of injection.
Age: 40.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Areflexia, Deafness neurosensory, Sudden hearing loss, Tinnitus, Tympanometry normal
Clinical narrative: Sudden hearing loss on the left side along with tinnitis. No vertigo, facial numbness, or pain. No known inciting event.  ENT evaluation showed on 1/13/10 moderate sensorineural hearing loss with absent L. acoustic reflexes at 500, 1000, and 2000 HZ. Tympanometry was normal as was the physical examination of the ear canal.
Age: 40.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Deafness, Ear, nose and throat examination abnormal, Tinnitus, Tympanometry normal
Clinical narrative: Sudden hearing loss on the left side along with tinnitis. No vertigo, facial numbness, or pain. No known inciting event.  ENT evaluation showed on 1/13/10 moderate sensorineural hearing loss with absent L. acoustic reflexes at 500, 1000, and 2000 HZ. Tympanometry was normal as was the physical examination of the ear canal.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Contusion, Erythema, Pain in extremity, Rash macular, Swelling
Clinical narrative: Right arm painful, swollen, red, bruised. The next day had red blotches from shoulder to elbow..  Went to doctor, started on Bactrim, Benadryl, and Zantac.
Age: 23.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Drug exposure during pregnancy, Incorrect dose administered, Medication error
Clinical narrative: MEDICATION ERROR, CLIENT GIVEN H1N1 AFTER RECEIVING H1N1 TWO WEEKS PRIOR.
Age: 23.0
Sex: F
Vaccine: FLU3, FLUN(H1N1)
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Complained of left arm pain after getting flu vaccine 11/4/09.  Intermittent pain, numbness and tingling from upper arm to hand.  Ibuprofen, ice, heat recommended, x-ray, follow up appointment if no improvement in 7-14 days.
Age: 46.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dysgeusia, Oral pruritus, Paraesthesia, Swollen tongue, Throat irritation
Clinical narrative: TONGUE SWELLING, TINGLING SENSATION IN MOUTH, METALLIC TASTE IN MOUTH, ITCHING TO ROOF OF MOUTH AND THROAT TREATMENT WAS BENADRYL ONE 25MG TAB PO AT 11:25 AM AND EPINEPHRINE 1:1000 (1 MG/ML) 0.3CC SQ AT 11:30 AM.
Age: 12.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Feeling abnormal
Clinical narrative: After injection was given, student/patient reported feeling "low".  An ice pack was applied to the back of the neck.  He was given 2 4 oz containers of apple juice.  He slowly drank the first container while sitting and talking with the nurse.  Afterwards student returned to class less anxious and more relaxed.
Age: 57.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Asthenia, Body temperature, Chills, Fatigue
Clinical narrative: 8:00 am - noticed weakness during exercise session, but not severe;   4:00 pm sudden onset of extreme exhaustion and joint aches;   5:00 pm sudden onset of chills, increased aches, headache, temp. of 100;  treated with Ibuprophen and Tylenol (alternately);  next day, 8:00 am, arm swollen and sore, temp normal, chills gone (in fact periods of feeling hot during night), headache about the same, aches decreased;    4:00 pm.  Chills and temp of 100 return, increased headache, sudden congestion of nasal passages, increased weakness;  continuing to take Ibuprofen and Tylenol, along with occassional nasal spray.
Age: 57.0
Sex: F
Vaccine: TD
Symptoms: Feeling hot, Headache, Nasal congestion, Oedema peripheral, Pain in extremity
Clinical narrative: 8:00 am - noticed weakness during exercise session, but not severe;   4:00 pm sudden onset of extreme exhaustion and joint aches;   5:00 pm sudden onset of chills, increased aches, headache, temp. of 100;  treated with Ibuprophen and Tylenol (alternately);  next day, 8:00 am, arm swollen and sore, temp normal, chills gone (in fact periods of feeling hot during night), headache about the same, aches decreased;    4:00 pm.  Chills and temp of 100 return, increased headache, sudden congestion of nasal passages, increased weakness;  continuing to take Ibuprofen and Tylenol, along with occassional nasal spray.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Death
Clinical narrative: unknown
Age: 10.0
Sex: M
Vaccine: FLU3, FLUN(H1N1)
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: MIST GIVEN TO CHILD REPORTING ASTHMA
Age: 64.0
Sex: M
Vaccine: DTAP
Symptoms: Induration, Rash erythematous
Clinical narrative: marked erythematous rash with associated induration of upper arm
Age: 5.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Pyrexia, Urticaria
Clinical narrative: Fever of 106.6.  No redness, hives.
Age: 9.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Vomiting
Clinical narrative: After administering nasal vaccine he threw up.  Prior to administration patient showed high anxiety.  Patient vomited again in nurse's station and was sent home.  Patient was breathing, walking and acting normal when left site.
Age: 9.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness
Clinical narrative: Patient complained of mild "dizziness."  Had her sit down with head between knees and applied ice to neck.  No other complaints, no signs of allergic reaction.  Patient ate lunch and reported feeling better.
Age: 3.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Pyrexia
Clinical narrative: high fever x 2 days & 2 nights
Age: 46.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Chest discomfort, Dry throat, Ear pain, Fatigue, Feeling of body temperature change
Clinical narrative: Dry sore throat, ear aches, feeling hot and cold, and today - 1/14/2010 tightness in my chest. Also very tired.
Age: 46.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Oropharyngeal pain
Clinical narrative: Dry sore throat, ear aches, feeling hot and cold, and today - 1/14/2010 tightness in my chest. Also very tired.
Age: 34.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Asthenia, Chills, Injection site rash, Pallor, Pyrexia
Clinical narrative: Severe Vomiting, fever, pale, chills, weak, rash at site of injection.
Age: 34.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Vomiting
Clinical narrative: Severe Vomiting, fever, pale, chills, weak, rash at site of injection.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, FLUN(H1N1), MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: RIGHT THIGH SWELLING AND REDNESS. TYLENOL PRESCRIBED 1 1/2 TSP 4-6 HRS
Age: 36.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Injection site anaesthesia, Injection site reaction, Paraesthesia
Clinical narrative: Day after injection L deltoid numbness tingling L 4-5 fingers - up arm L and later in day "tingling Rt 4th and 5th fingers" small spot numbness upper lip.
Age: 51.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Feeling abnormal, Pyrexia, Retching
Clinical narrative: Pt developed low grade (100 degree - 101 degree) fever and dry heaving and overall "yucky" feeling 4 days after getting H1N1 vaccine. Pt wondered if it was related. I told them I didn't think so, but I would report it anyway. Still feels like that.
Age: 59.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Syringe issue
Clinical narrative: Syringe broke as shot was being given. Pt did not get enough vaccine per Dr. 2nd shot given.
Age: 4.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Vomiting
Clinical narrative: Per telephone conversation with patient father he states that his daughter vomiting early this morning. Returned to school the following day.
Age: 36.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Drug administration error
Clinical narrative: Pt thought the shot was too high, needle in too deep. Mentioned the above statements to his wife the same evening as receiving the shot.
Age: 17.0
Sex: F
Vaccine: FLU(H1N1), HEPA, VARCEL
Symptoms: Chest discomfort, Pruritus, Throat irritation, Throat tightness, Urticaria
Clinical narrative: HAV, VARIVAX, & H1N1 vaccines admin. at approx 1:15pm. States started breaking out in hives on her chest at approx. 145pm with itching on her chest & arms. Between 230p-245p started feeling chest tightness & at 3p started facing tightness & itching in her throat.
Age: 6.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Decreased activity, Pancreas infection, Pollakiuria, Thirst, Type 1 diabetes mellitus
Clinical narrative: Mother noticed on 12/16 & 17/2009 child not as active.  Drinking lots of water and getting up to urinate two or three time at night.  Mother made appt. with PMD for Jan. 4, 2010.  He was told he has an infection of the pancreas and sent to Hospital for two days.  A second diagnosis of Diabetes Type 1 and sent to another Hospital for 3 days.
Age: 86.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Convulsion, Dizziness
Clinical narrative: Pt felt lightheaded while shopping so she sat down.  We asked if she had eaten today and got her some crackers and water.  She sat down in a chair for a few moments then began convulsing.  Moved her to the floor and EMTs showed up immediately after.  Convulsions lasted about 30 seconds.  Incident occurred approx. 30 minutes after administration of H1N1 vaccine.
Age: 42.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Appetite disorder, Chills, Eye pain, Fatigue, Headache
Clinical narrative: Body feeling achey, hungry, later developed chills, headache behind the eyes, fatigue, fever
Age: 42.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Pain, Pyrexia
Clinical narrative: Body feeling achey, hungry, later developed chills, headache behind the eyes, fatigue, fever
Age: 5.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Rash
Clinical narrative: Grandmother stated she noted a heat rash type rash on childs back when she gave her a bath.  No respiratory distress.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR
Symptoms: Blood cortisol normal, Convulsion, Hypoglycaemia, Insulin C-peptide increased, Metabolic function test normal
Clinical narrative: Patient suffered seizure activity and severe hypoglycemia x 9 hours, requiring multiple dextrose loads and dextrose by I.V.
Age: 66.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Patient reports breaking out in hives and itching all over that subsequently led to her going to the ER. This started 10 days after she got the H1N1 vaccine.
Age: 57.0
Sex: F
Vaccine: FLUX, UNK
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Area of vaccination (arm) became red and sore.  Area of redness, swelling and soreness increased for about 7 days.  Redness, swelling and soreness was significant.  It remained about the same for almost a month.  It took about another 2 months for the redness, swelling and soreness to completely go away.  I did tell my doctor who felt it was a very unusual reaction.  I had no shortness of breath in the reaction.   When I had the vaccination I told the pharmacy who administered the vaccination about my allergies.  I didn't know it should be reported until I had my H1N1 vaccination and mentioned the reaction to the pharmacy (Walgreens)
Age: 15.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Chest pain, Dizziness, Electrocardiogram normal, Injection site pain, Laboratory test normal
Clinical narrative: 12/29/09 Pt arrived to hospital via ambulance with c/o light headedness, dizziness, blurred vision and left arm pain where she received H1N1. Sx's occurred after waking up in am. C/o chest pain as well. ER diagnosed pt with vaccination side effect - Rule out, viral syndrome - rule out. Per mom 1/14/10 pt recovered.
Age: 15.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Vaccination complication, Vision blurred
Clinical narrative: 12/29/09 Pt arrived to hospital via ambulance with c/o light headedness, dizziness, blurred vision and left arm pain where she received H1N1. Sx's occurred after waking up in am. C/o chest pain as well. ER diagnosed pt with vaccination side effect - Rule out, viral syndrome - rule out. Per mom 1/14/10 pt recovered.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Electroencephalogram, Fatigue, Loss of consciousness, Syncope
Clinical narrative: C/O tiredness 1/13 (one day after vaccines), walked to classroom teacher during class and had syncopal/loss of consciousness for 3 seconds. No known seizure activity, no prior history of syncope, no fevers. Went to school nurse, seemed fine after. Had normal breakfast that morning, event not associated with exertion.
Age: 57.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Oedema peripheral, Skin warm
Clinical narrative: arm swelled up to 2x normal size and extended down to elbow. After 48 hours, arm is still visibly swollen. No redness, no temp, skin sl warm to touch. In process of recovery.
Age: 0.6
Sex: M
Vaccine: DTAP, HIBV, PNC, RV5
Symptoms: Appendicectomy, Barium enema abnormal, Erythema infectiosum, Haematochezia, Intussusception
Clinical narrative: This report was identified from a line listing obtained on requested by the Company from the FDA under the Freedom of Information Act. A 7 month old male with viral exanthema and probable fifth disease and no medical history was vaccinated orally with the third dose of ROTATEQ (lot# 663462/0286Y) on 28-MAY-2009. Concomitant therapy included the third dose of TRIPEDIA (lot# C3140AA) vaccinated in the left leg, the third dose of ACTHIB (lot# UF604AB) vaccinated in the right leg and the third dose of PREVENAR (lot# D46873) vaccinated in the right leg on the same date. On 30-MAY-2009 the patient developed intussusception requiring surgical reduction. The patient also had symptoms of resolving virus+viral exanthem consistent with parvovirus (fifth's disease) on the day of when vaccines given. On 15-JUN-2009 hospital medical records of 31-MAY-2009 to 03-JUN-2009 was received. Final diagnosis: intussception, status post laparotomy with manual reduction and appendectomy records reveal patient experienced bilious emesis and bloody stools for 1 day. Surgical consult was done. The patient was sent to operating room when barium enema failed to reduce. The patient progressed well and discharged to home. Contrast enema was performed on 16-JUN-2009. Medical record indicated that barium enema diagnosed intussusception but unable to reduce. A standard lot check investigation was performed. All in-process quality checks for lot number 663462/0286Y were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. The listing indicated that the events required hospitalization, was considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID# is 348664. No further information is available.
Age: 0.6
Sex: M
Vaccine: DTAP, HIBV, PNC, RV5
Symptoms: Laparotomy, Surgery, Vomiting, X-ray
Clinical narrative: This report was identified from a line listing obtained on requested by the Company from the FDA under the Freedom of Information Act. A 7 month old male with viral exanthema and probable fifth disease and no medical history was vaccinated orally with the third dose of ROTATEQ (lot# 663462/0286Y) on 28-MAY-2009. Concomitant therapy included the third dose of TRIPEDIA (lot# C3140AA) vaccinated in the left leg, the third dose of ACTHIB (lot# UF604AB) vaccinated in the right leg and the third dose of PREVENAR (lot# D46873) vaccinated in the right leg on the same date. On 30-MAY-2009 the patient developed intussusception requiring surgical reduction. The patient also had symptoms of resolving virus+viral exanthem consistent with parvovirus (fifth's disease) on the day of when vaccines given. On 15-JUN-2009 hospital medical records of 31-MAY-2009 to 03-JUN-2009 was received. Final diagnosis: intussception, status post laparotomy with manual reduction and appendectomy records reveal patient experienced bilious emesis and bloody stools for 1 day. Surgical consult was done. The patient was sent to operating room when barium enema failed to reduce. The patient progressed well and discharged to home. Contrast enema was performed on 16-JUN-2009. Medical record indicated that barium enema diagnosed intussusception but unable to reduce. A standard lot check investigation was performed. All in-process quality checks for lot number 663462/0286Y were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. The listing indicated that the events required hospitalization, was considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID# is 348664. No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Arachnoid cyst, Areflexia, Asthenia, Back pain, Blood product transfusion
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 26 year old female with a history of anaemia, previous-smoker and family history of GBS, on 17-AUG-2009 was vaccinated with a fourth dose of GARDASIL (lot # 662404/0312Y, route unknown) in the left arm. Concomitant therapy included YAZ. On 30-SEP-2009 the patient experienced arachnoid cyst, areflexia, asthenia, back pain, blood product transfusion, endotracheal intubation, Guillain-Barre syndrome, haemothorax, hypoaesthesia, hypoaesthesia oral, influenza like illness, intensive care, muscular weakness, plasmapheresis, reflex test abnormal, respiratory failure and tracheostomy. The patient experienced ascending paralysis, respiratory failure requiring intubation. She had IVIG (intravenous immunoglobulin) for 5 days followed by plasmapheresis for 5 days. The patient remained intubed and was in ICU (intensive care unit). On 22-OCT-2009 Hospital records were received for dates 01-OCT-2009 to 26-OCT-2009. The patient was currently diagnosed as GBS (Guillain-Barre syndrome). On 01-OCT-2009 the patient presented to ER with complaint of numbness in all extremities, pain, weakness in legs, back pain, numbness in mouth. Patient was in ER 1 day prior and sent home. Symptoms increased patient returned to ER. The patient complained of flu like symptoms 10 days prior. Assessment: WNL (Within normal limits) except, absent knee reflexes, hypoflex of lower extremities (+) intramuscular fluid around dpine at occipital cervical junction. The patient's diagnoses at time of assessment were GBS vs idiopathic polyneuropathy vs MS (Multiple Sclerosis). Patient was admitted to medical unit, symptoms deteriorated and she was transferred to ICU. Further assessments: absent deep tendon reflexes of upper and lower extremities, complaint of pain throughout entire spine. MRI of spine (+) arachnoid cyst. On 05-OCT-2009 the patient was intubated, and treatment with IVIG, no response. The patient had lab test of Plasmapheresis. The patient was diagnosed as GBS, respiratory failure and hemothorax. ON 15-OCT-2009 tracheotomy was placed. The patient required ER visit, and the outcome was not reported at the time of report. Diagnostics and labs included: EKG sinus tachycardia; DVT(-); abdominal US(-); CXR abnormal-LLL infiltrates, CT chest (-); LP abnomral-CSF protein(H); CSF glucose(H); CSF WBC(H); CSF ALB 9(L). The listing indicated that one or more of the events required hospitalization, required extended hospital stay , was considered to be immediately life-threatening. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. The originally reporting source was not provided. The VAERS ID # is 361227.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Multiple sclerosis, Muscular weakness, Pain, Plasmapheresis, Polyneuropathy idiopathic progressive
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 26 year old female with a history of anaemia, previous-smoker and family history of GBS, on 17-AUG-2009 was vaccinated with a fourth dose of GARDASIL (lot # 662404/0312Y, route unknown) in the left arm. Concomitant therapy included YAZ. On 30-SEP-2009 the patient experienced arachnoid cyst, areflexia, asthenia, back pain, blood product transfusion, endotracheal intubation, Guillain-Barre syndrome, haemothorax, hypoaesthesia, hypoaesthesia oral, influenza like illness, intensive care, muscular weakness, plasmapheresis, reflex test abnormal, respiratory failure and tracheostomy. The patient experienced ascending paralysis, respiratory failure requiring intubation. She had IVIG (intravenous immunoglobulin) for 5 days followed by plasmapheresis for 5 days. The patient remained intubed and was in ICU (intensive care unit). On 22-OCT-2009 Hospital records were received for dates 01-OCT-2009 to 26-OCT-2009. The patient was currently diagnosed as GBS (Guillain-Barre syndrome). On 01-OCT-2009 the patient presented to ER with complaint of numbness in all extremities, pain, weakness in legs, back pain, numbness in mouth. Patient was in ER 1 day prior and sent home. Symptoms increased patient returned to ER. The patient complained of flu like symptoms 10 days prior. Assessment: WNL (Within normal limits) except, absent knee reflexes, hypoflex of lower extremities (+) intramuscular fluid around dpine at occipital cervical junction. The patient's diagnoses at time of assessment were GBS vs idiopathic polyneuropathy vs MS (Multiple Sclerosis). Patient was admitted to medical unit, symptoms deteriorated and she was transferred to ICU. Further assessments: absent deep tendon reflexes of upper and lower extremities, complaint of pain throughout entire spine. MRI of spine (+) arachnoid cyst. On 05-OCT-2009 the patient was intubated, and treatment with IVIG, no response. The patient had lab test of Plasmapheresis. The patient was diagnosed as GBS, respiratory failure and hemothorax. ON 15-OCT-2009 tracheotomy was placed. The patient required ER visit, and the outcome was not reported at the time of report. Diagnostics and labs included: EKG sinus tachycardia; DVT(-); abdominal US(-); CXR abnormal-LLL infiltrates, CT chest (-); LP abnomral-CSF protein(H); CSF glucose(H); CSF WBC(H); CSF ALB 9(L). The listing indicated that one or more of the events required hospitalization, required extended hospital stay , was considered to be immediately life-threatening. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. The originally reporting source was not provided. The VAERS ID # is 361227.