chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.3
Sex: F
Vaccine: MMR
Symptoms: Muscle twitching, Pyrexia, Urine analysis
Clinical narrative: MMR vaccine was administered on June 18, around 10:30 a.m.  On Wed., July 20, patient began having seizures that were visible by eye twitches. She developed a fever that ran between 100.4 to 102 on Friday, June 22, 2007. After repeated phone calls from Wed (6/20)to Saturday (6/23), and one visit to the pediatrician (on 6/21), who said it was not a seizure, I took her to Emergency Room at which time the ER physician said immediately they were certainly seizures. Patient was admitted to Hospital from June 23 until discahrge on July 7, 2007. She was given 5 different meds before the seizures stopped and were no longer occurring. (There was some minor eye irritation on June 19, but we are not sure if that was the same twitching that began on June 20.) 8/30/07-recprds received for DOS 6/23-7/7/07-DC DX: Infantile hemiplegia. Conjunctivitis. Exotropia. Dermatitis due to drug and medicine taken internally. Unspecified anticonvulsant causing adverse effects in therapeutic use. Fever started yesterday and vomiting today. Fever 102. Patient saw PMD yesterday, probably had conjunctivitis. Temp in ED 100.7. Seizure like episodes described as 'zoning out' staring into space and drooling. Experiencing drainage from eye saw ophthalmologist who diagnosed conjunctivitis. Patient exhibited 2 episodes of seizure during exam consisting of rightward gaze, horizontal nystagmus, twitching bilateral eyelids. Annual followup 01/4/2010 MMR should be given separately (as 3 separate vaccines). I do not think thimerosal has anything to do with it, as ongoing controversy predicts. I do believe that 3 live viruses (MMR) option in one shot is welly too much for a child with known neurological injury and/or past seizures (see MMR vaccine P.I. enclosed). Many times this vaccine is given to children with no known cerebral injury but the is an underlying sine. This is dense and may cause problems. Obviously we (healthcare) cannot do MRIs on all children (whether known or unknown cerebral injury) before administering MMR vaccine. So why take a chance!?! Healthcare would benefit all around as would children and thier families. The health insurance companies would have to pay 3 administration vaccination fees, but that is pennies compared to what they later must pay for tests, therapy, hospitalization, specialist dr. visists, etc! Call a united you want to discuss this. Someone in poner of this needs to stand up for more children. Please share this with those who can affect  helpfull change!
Age: 14.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site is swollen, red, warm to touch, slightly itchy.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Cold compress therapy, Injection site erythema, Injection site swelling
Clinical narrative: Reddness and swelling noted to lt deltoid the day after receiving vaccines.Cold compresses applied and tylenol given.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: A day or 2 after injection, redness and swelling in site, very itchy, pt. determined allergy to vaccine.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Pyrexia, Skin warm, Vomiting
Clinical narrative: Reportedly developed a fever and vomited -temperature was not taken but mom states ''felt very warm''.Symptoms developed a few hours after receiving first Hep A vaccine, mom declines any further Hep A vaccine to be given.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS, VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Initial redness,pain and itching at site of injection. Next morning redness radiated down back of arm approx. halfway to elbow and around to front of arm as a band in the middle of arm.  2-3 days later all the redness turned into a bruise which lasted approx. 3 weeks.  Initial pain severe enough to require Ibuprofen for 48 hours.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS, VARZOS
Symptoms: Contusion, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Initial redness,pain and itching at site of injection. Next morning redness radiated down back of arm approx. halfway to elbow and around to front of arm as a band in the middle of arm.  2-3 days later all the redness turned into a bruise which lasted approx. 3 weeks.  Initial pain severe enough to require Ibuprofen for 48 hours.
Age: 11.0
Sex: M
Vaccine: YF
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching and hives over upper body 40-60 min after YF vaccine; call to UC and advised to given child Benadryl - this was taken at 1800 and father reports itching resolved and hives nearly gone at 2300; next day symptoms resolved and child went to school.
Age: 25.0
Sex: F
Vaccine: HEPAB
Symptoms: Anaemia, Blood bilirubin increased, Chills, Chromaturia, Diarrhoea
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of nausea in a 25-year-old female subject who was vaccinated with Twinrix for prophylaxis. Concurrent vaccination included tuberculin PPD given on 5 June 2007. There were no concurrent medications. On 5 June 2007 at 11:30 the subject received 1st dose of Twinrix at 1.0 ml in the right arm. Two weeks after vaccination with Twinrix, the subject experienced nausea and fatigue. One week later, she experienced diarrhea followed days later by high fever (103 F), chills and severe headache. On 01 July 2007, the subject experienced vomiting, urine discoloration (rust colored) and her eyes and skin were jaundiced. The subject was hospitalized on 02 July 2007. Her platelet count was 20, her bilirubin 7.9, she was anemic and her liver function tests were elevated. The subject remained hospitalised at the time of reporting and the healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were possibly related to vaccination with Twinrix.
Age: 25.0
Sex: F
Vaccine: HEPAB
Symptoms: Eye disorder, Fatigue, Headache, Hepatic function abnormal, Jaundice
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of nausea in a 25-year-old female subject who was vaccinated with Twinrix for prophylaxis. Concurrent vaccination included tuberculin PPD given on 5 June 2007. There were no concurrent medications. On 5 June 2007 at 11:30 the subject received 1st dose of Twinrix at 1.0 ml in the right arm. Two weeks after vaccination with Twinrix, the subject experienced nausea and fatigue. One week later, she experienced diarrhea followed days later by high fever (103 F), chills and severe headache. On 01 July 2007, the subject experienced vomiting, urine discoloration (rust colored) and her eyes and skin were jaundiced. The subject was hospitalized on 02 July 2007. Her platelet count was 20, her bilirubin 7.9, she was anemic and her liver function tests were elevated. The subject remained hospitalised at the time of reporting and the healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were possibly related to vaccination with Twinrix.
Age: 25.0
Sex: F
Vaccine: HEPAB
Symptoms: Liver function test abnormal, Nausea, Platelet count decreased, Pyrexia, Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of nausea in a 25-year-old female subject who was vaccinated with Twinrix for prophylaxis. Concurrent vaccination included tuberculin PPD given on 5 June 2007. There were no concurrent medications. On 5 June 2007 at 11:30 the subject received 1st dose of Twinrix at 1.0 ml in the right arm. Two weeks after vaccination with Twinrix, the subject experienced nausea and fatigue. One week later, she experienced diarrhea followed days later by high fever (103 F), chills and severe headache. On 01 July 2007, the subject experienced vomiting, urine discoloration (rust colored) and her eyes and skin were jaundiced. The subject was hospitalized on 02 July 2007. Her platelet count was 20, her bilirubin 7.9, she was anemic and her liver function tests were elevated. The subject remained hospitalised at the time of reporting and the healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were possibly related to vaccination with Twinrix.
Age: 0.4
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Intussusception 7/26/07-records received for DOS 6/30-7/7/07-DC DX: Intussusception. Exploratory laparotomy and appendectomy on 7/2/07. On 6/30/06- C/O fever, nausea vomiting since night before. Sudden onset of vomiting became projectile. Bloody DiarrheaTemp 100.5.
Age: 0.4
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Appendicectomy, Blood potassium decreased, Blood sodium normal, Culture stool negative, Culture urine negative
Clinical narrative: Intussusception 7/26/07-records received for DOS 6/30-7/7/07-DC DX: Intussusception. Exploratory laparotomy and appendectomy on 7/2/07. On 6/30/06- C/O fever, nausea vomiting since night before. Sudden onset of vomiting became projectile. Bloody DiarrheaTemp 100.5.
Age: 0.4
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Diarrhoea haemorrhagic, Explorative laparotomy, Intussusception, Lymphocyte count normal, Monocyte count normal
Clinical narrative: Intussusception 7/26/07-records received for DOS 6/30-7/7/07-DC DX: Intussusception. Exploratory laparotomy and appendectomy on 7/2/07. On 6/30/06- C/O fever, nausea vomiting since night before. Sudden onset of vomiting became projectile. Bloody DiarrheaTemp 100.5.
Age: 0.4
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Nausea, Neutrophil count increased, Pyrexia, Surgery, Vomiting
Clinical narrative: Intussusception 7/26/07-records received for DOS 6/30-7/7/07-DC DX: Intussusception. Exploratory laparotomy and appendectomy on 7/2/07. On 6/30/06- C/O fever, nausea vomiting since night before. Sudden onset of vomiting became projectile. Bloody DiarrheaTemp 100.5.
Age: 0.4
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Vomiting projectile, X-ray with contrast upper gastrointestinal tract
Clinical narrative: Intussusception 7/26/07-records received for DOS 6/30-7/7/07-DC DX: Intussusception. Exploratory laparotomy and appendectomy on 7/2/07. On 6/30/06- C/O fever, nausea vomiting since night before. Sudden onset of vomiting became projectile. Bloody DiarrheaTemp 100.5.
Age: 1.0
Sex: M
Vaccine: HBHEPB, PNC
Symptoms: Febrile convulsion, Partial seizures
Clinical narrative: Febrile seizure - focal for 20 minutes. Tx'd with Ativan, Dilantin 8/23/07-records received for DOS 7/5-7/8/07-DC DX:Epilepsia partialis continua. Febrile convulsions. admitted in status epilepticus. Developed fever to 38.5 on day of vaccine. Twitching on right side persisted for 2 hours.
Age: 54.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Abdominal pain upper, Back disorder, Back pain, Bone pain, Eye pruritus
Clinical narrative: Great pain on both shoulders and neck; bones and muscles. I can't write continuously with my right hand. Objects fall from my right hand (pencils, pens, papers, etc). Left shoulder muscles at rotator cuff feel like falling apart from bones and trembles. My eye view blacks out, and hazy frequent. Lumbar area hurts, eyes itches and gets red;aphyxiation.  7/18/07-records received-DX hypertriglyceridemia. GERD. Caridac Arrhythmia, Left shoulder tendinitis. Depression. Diverticular disease. DDD of cervical spine. HX of trauma when on active service on right shoulder that requires surgery. 1/11/2010 I still suffering of great pains on my shoulders, specially the left one, my cervical 5 and 6 are clogging my spinal cords. Continues super strong heachaches, my muscles sores everday, flips and strains frequently. Many problems with my stomach, my intestine do not work properly. Hospital discovers that my left floot grown 1 1/2" and my back hurts. Due to this I am not walking straight. My eyes are red, and the itch drives me crazy. Allergies swell ups my eyes. Special allergy to seafood (shrimps, craps, etc) which I have never had it before. Left eye frequently swells up including the left cheek. Bones and muscles deep pain when waling up and during the day-back pain. Lumbars and cervical extremely painful sometimes loosing my sight, everything gets dark for a few minutes, continuous headache, extreme itch on both eyes everyday.
Age: 54.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Eye swelling, Food allergy, Gait disturbance, Headache, Musculoskeletal pain
Clinical narrative: Great pain on both shoulders and neck; bones and muscles. I can't write continuously with my right hand. Objects fall from my right hand (pencils, pens, papers, etc). Left shoulder muscles at rotator cuff feel like falling apart from bones and trembles. My eye view blacks out, and hazy frequent. Lumbar area hurts, eyes itches and gets red;aphyxiation.  7/18/07-records received-DX hypertriglyceridemia. GERD. Caridac Arrhythmia, Left shoulder tendinitis. Depression. Diverticular disease. DDD of cervical spine. HX of trauma when on active service on right shoulder that requires surgery. 1/11/2010 I still suffering of great pains on my shoulders, specially the left one, my cervical 5 and 6 are clogging my spinal cords. Continues super strong heachaches, my muscles sores everday, flips and strains frequently. Many problems with my stomach, my intestine do not work properly. Hospital discovers that my left floot grown 1 1/2" and my back hurts. Due to this I am not walking straight. My eyes are red, and the itch drives me crazy. Allergies swell ups my eyes. Special allergy to seafood (shrimps, craps, etc) which I have never had it before. Left eye frequently swells up including the left cheek. Bones and muscles deep pain when waling up and during the day-back pain. Lumbars and cervical extremely painful sometimes loosing my sight, everything gets dark for a few minutes, continuous headache, extreme itch on both eyes everyday.
Age: 54.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Myalgia, Neck pain, Ocular hyperaemia, Rotator cuff syndrome, Spinal cord compression
Clinical narrative: Great pain on both shoulders and neck; bones and muscles. I can't write continuously with my right hand. Objects fall from my right hand (pencils, pens, papers, etc). Left shoulder muscles at rotator cuff feel like falling apart from bones and trembles. My eye view blacks out, and hazy frequent. Lumbar area hurts, eyes itches and gets red;aphyxiation.  7/18/07-records received-DX hypertriglyceridemia. GERD. Caridac Arrhythmia, Left shoulder tendinitis. Depression. Diverticular disease. DDD of cervical spine. HX of trauma when on active service on right shoulder that requires surgery. 1/11/2010 I still suffering of great pains on my shoulders, specially the left one, my cervical 5 and 6 are clogging my spinal cords. Continues super strong heachaches, my muscles sores everday, flips and strains frequently. Many problems with my stomach, my intestine do not work properly. Hospital discovers that my left floot grown 1 1/2" and my back hurts. Due to this I am not walking straight. My eyes are red, and the itch drives me crazy. Allergies swell ups my eyes. Special allergy to seafood (shrimps, craps, etc) which I have never had it before. Left eye frequently swells up including the left cheek. Bones and muscles deep pain when waling up and during the day-back pain. Lumbars and cervical extremely painful sometimes loosing my sight, everything gets dark for a few minutes, continuous headache, extreme itch on both eyes everyday.
Age: 54.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Surgery, Tremor, Vision blurred, Visual disturbance
Clinical narrative: Great pain on both shoulders and neck; bones and muscles. I can't write continuously with my right hand. Objects fall from my right hand (pencils, pens, papers, etc). Left shoulder muscles at rotator cuff feel like falling apart from bones and trembles. My eye view blacks out, and hazy frequent. Lumbar area hurts, eyes itches and gets red;aphyxiation.  7/18/07-records received-DX hypertriglyceridemia. GERD. Caridac Arrhythmia, Left shoulder tendinitis. Depression. Diverticular disease. DDD of cervical spine. HX of trauma when on active service on right shoulder that requires surgery. 1/11/2010 I still suffering of great pains on my shoulders, specially the left one, my cervical 5 and 6 are clogging my spinal cords. Continues super strong heachaches, my muscles sores everday, flips and strains frequently. Many problems with my stomach, my intestine do not work properly. Hospital discovers that my left floot grown 1 1/2" and my back hurts. Due to this I am not walking straight. My eyes are red, and the itch drives me crazy. Allergies swell ups my eyes. Special allergy to seafood (shrimps, craps, etc) which I have never had it before. Left eye frequently swells up including the left cheek. Bones and muscles deep pain when waling up and during the day-back pain. Lumbars and cervical extremely painful sometimes loosing my sight, everything gets dark for a few minutes, continuous headache, extreme itch on both eyes everyday.
Age: 1.0
Sex: F
Vaccine: DTAP, HIBV, MMRV, PNC
Symptoms: Convulsion, Pyrexia, Rash, Viral infection
Clinical narrative: Pt has immunizations on 6/14/07, 6/23/07 while on vacation she had a fever, seizure activity and later a rash. Was taken to hospital for treatment. I need to file a VAER's report and need your information from this hospital visit. records received with report-DX febrile seizure right upper lobe pneumonia.
Age: 0.7
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Extubation, Febrile convulsion, Intensive care, Intubation
Clinical narrative: Patient had a complex febrile seizure lasted 30 minutes taken to community ER. Intubated and transferred, extubated on arrival to PICU was discharged on 6/18/07. 7/25/07-records received from facility-Assessment: complex febrile seizure, normal neurologic exam. Source of fever is esstentially a viral syndrome versus onset of bacterial pneumonia versus related to immunization. Seizure lasted 30 minutes.  Temp 102 (R) per mom. Required intubation until seen in receiving facility and subsequently extubated.
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Bone pain, Depression, Echocardiogram abnormal, Erectile dysfunction, Headache
Clinical narrative: Headache, migraine headaches, bone pains, nerve conditions, receiving treatment. 8/1/07-records received-DX: Tinea. Hypercholesterolemia. Back pain. Hernia, inguinal with repair. Major Depressive Disorder, Recurrent. Dyssomia. Calcium deposits in tendon and bursa. Osteoarthritis. Hypertension. Headaches. 1/11/2010 I feel with arthritis all over my body, I suffer of depression and have sexual problems (E.D). I feel numbness in my arms and hands and pain all over my body and hypertension, headaches and cholesterol.
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Hypoaesthesia, Migraine, Nervous system disorder, Nuclear magnetic resonance imaging brain, Polyarthritis
Clinical narrative: Headache, migraine headaches, bone pains, nerve conditions, receiving treatment. 8/1/07-records received-DX: Tinea. Hypercholesterolemia. Back pain. Hernia, inguinal with repair. Major Depressive Disorder, Recurrent. Dyssomia. Calcium deposits in tendon and bursa. Osteoarthritis. Hypertension. Headaches. 1/11/2010 I feel with arthritis all over my body, I suffer of depression and have sexual problems (E.D). I feel numbness in my arms and hands and pain all over my body and hypertension, headaches and cholesterol.
Age: 0.1
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Vomiting after feeds 6/3 to 6/8
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient received Tdap on 6/26/07. On 6/27/07, patient noted right arm swelling, erythema, pruritus and mild warmth in right deltoid area at site of injection. No fever or pain reported. Swelling with erythema 7 cm x 8 cm in site.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness
Clinical narrative: By phone call, pt reported a period of light headedness and dizziness about 18-20 hrs after the vaccine, lasting about 1 hour, self resolved after visit to school nurse office.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, RV5
Symptoms: Fluid replacement, Vomiting
Clinical narrative: Vomiting since last visit. Was seen in office and in ER on 6/1/07. Recd IV fluids and was sent home.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, RV5
Symptoms: Vomiting
Clinical narrative: Vomiting since last visit. Was seen in office and in ER on 6/1/07. Recd IV fluids and was sent home.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Type III immune complex mediated reaction
Clinical narrative: 10 x 15 cm Arthus reaction right arm
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Rash macular, Skin discolouration
Clinical narrative: Pt developed whole body erythemous macular rash mild itchy. No SOB/chest tightness. Seen pt instructed to take Benadryl 25mg TID X 5 days. Go to ER sx worsen. F/U sx continue.
Age: 0.3
Sex: M
Vaccine: HIBV, IPV, PNC, RV5, TDAP
Symptoms: Diarrhoea, Inappropriate schedule of drug administration
Clinical narrative: Loose watery stools 8-10d within 2 days of getting shots.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Decreased appetite, Diarrhoea, Vomiting
Clinical narrative: Rotateq on 6/25. 6/27 vomited by 2 in am. Diarrhea - water, explosive, x 10 on 6-27. Appetite decrease 6/28 - diarrhea x 3, appetite nl.
Age: 51.0
Sex: F
Vaccine: PNC, PPV
Symptoms: Chills, Headache, Injection site swelling, Pyrexia
Clinical narrative: 7/3/07 Approx 3 hr after pneumo. vac. given (L) arm swelling, chills fever and HA. Husband gave Tylenol which was helpful (decreased H/a and chills fever) 7/4 (07 when client woke (L) arm swelling from (L) elbow to collar bone area. Client stated she didn't go to MD due to holiday. nonone there. 7/5/07 MD visit to Dr -advised Benadry/Tylenol and see surgeon if symptoms didn't get better will admin antibiotics. Client in today to report 7/6/07. Stated swelling has gotten better with Benadryl. Client going to Dr at 10:45 am. Antibiotics and Dr
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Headache, Pain
Clinical narrative: 1 day after HPV - Sharp pain in head lasted a few seconds, achy, low grade temp.
Age: 12.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Erythema, Induration
Clinical narrative: R arm, 5x3 cm zone of erythema, induration this was measured 2 days after the injection.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Pain
Clinical narrative: 1 day after Varivax was administered, child developed redness, pain and swelling at injection site. 2 days after, the area of erythema and induration measured 2x3 inches. Child c/o pain an itchiness. Pt was afebrile no local reactions with the other vaccines.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Pruritus
Clinical narrative: 1 day after Varivax was administered, child developed redness, pain and swelling at injection site. 2 days after, the area of erythema and induration measured 2x3 inches. Child c/o pain an itchiness. Pt was afebrile no local reactions with the other vaccines.
Age: 11.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Erythema, Induration
Clinical narrative: 1 day after injection, patient had erythema and induration measuring 2x3 inches on R upper arm.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Coronary artery disease, Echocardiogram abnormal, Kawasaki's disease, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: Fever without source - labs obtained over course of week - increase WBC, increase ESR - admitted to hospital - Echo confirmed Kawasaki's with coronary artery dilatation. 8/15/07-records received for DOS 03/23-03/27/07-DC DX: Atypical Kawasaki Disease. Allergy/reaction. Presented to ED with reports of fever range 101-103 rectally times 7 days. Increased fussiness, decreased activity, slightly decreased po, decreased UOP. No rash, vomiting or diarrhea. 1 day HX of runny nose/nasal congestion. Per 60 day follow up: As of 6/07, his R conranary artery still ectasic, but no aneurysms. He is following up with cardiology evyr 6 mos. and continuing on daily aspirin.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: White blood cell count increased
Clinical narrative: Fever without source - labs obtained over course of week - increase WBC, increase ESR - admitted to hospital - Echo confirmed Kawasaki's with coronary artery dilatation. 8/15/07-records received for DOS 03/23-03/27/07-DC DX: Atypical Kawasaki Disease. Allergy/reaction. Presented to ED with reports of fever range 101-103 rectally times 7 days. Increased fussiness, decreased activity, slightly decreased po, decreased UOP. No rash, vomiting or diarrhea. 1 day HX of runny nose/nasal congestion. Per 60 day follow up: As of 6/07, his R conranary artery still ectasic, but no aneurysms. He is following up with cardiology evyr 6 mos. and continuing on daily aspirin.
Age: 48.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Day after injection site is bright red with knot and hot - area is about 2 x 3 inches (Tetanus) aches in arm and neck.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site bruising, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Nausea (within an hour) for 3 hours. Fever (within an hour) for 12 hours. Bruising at injection site - 4/3/07 - lasting two weeks - softball size. Swelling at injection site - 4/2/07 lasting two weeks at injection site - 4/2/07 - lasting two weeks - softball size - non-responsive to Ibuprofen.
Age: 14.0
Sex: F
Vaccine: FLU3, HEPA, HPV4
Symptoms: Injection site bruising, Injection site swelling, Pyrexia
Clinical narrative: Fever - 12/29/06, bruising at the injection site 12/30/06, swelling approximately golf size at the injection site - 12/30/06.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Redness, soreness and swelling at site of injection. Also some itching. Later that day and next some slight headache and dizziness. Symptoms lasted 5-6 days
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Redness, soreness and swelling at site of injection. Also some itching. Later that day and next some slight headache and dizziness. Symptoms lasted 5-6 days
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Rash pruritic
Clinical narrative: Pruritic rash L arm, that extended to abdomen and back. Rash started the day after receiving injections. Did not report to provider at the time. Resolved at f/u visit 7/3/07
Age: 14.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Body temperature increased, Culture throat, Dizziness, Dry mouth, Headache
Clinical narrative: Woke up 7/11/07 with increased temp 101.4, c/o H/A, nausea, dry mouth, dizziness
Age: 14.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Nausea, Streptococcal identification test negative
Clinical narrative: Woke up 7/11/07 with increased temp 101.4, c/o H/A, nausea, dry mouth, dizziness
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: injection site was noted, red, "rashy" 1 day after immunization.
Age: 12.0
Sex: F
Vaccine: YF
Symptoms: Headache
Clinical narrative: Had yellow fever vaccine 7/7/07 developed headache evening of 7/7/07. Developed headache evening of 7/7/07 which lasted until evening 7/10/07 - pain relieved with Motrin.
Age: 36.0
Sex: F
Vaccine: YF
Symptoms: Axillary pain, Dizziness, Headache, Injected limb mobility decreased, Injection site erythema
Clinical narrative: Received only yellow fever vaccine 7/7/07. Developed 2 inch red swollen painful area at injection site several hours later-also developed significant pain from injection site into Axilla-Pain level 7-8 on 0-10 scale. Unable to use arm due to pain. Also had significant dizziness and headache that started evening of 7/7/07. Advised to take Advil for discomfort-it did help Dizziness did not get better until 7/10/07-Examined in office by MD-7/11/07
Age: 36.0
Sex: F
Vaccine: YF
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Received only yellow fever vaccine 7/7/07. Developed 2 inch red swollen painful area at injection site several hours later-also developed significant pain from injection site into Axilla-Pain level 7-8 on 0-10 scale. Unable to use arm due to pain. Also had significant dizziness and headache that started evening of 7/7/07. Advised to take Advil for discomfort-it did help Dizziness did not get better until 7/10/07-Examined in office by MD-7/11/07
Age: 15.0
Sex: M
Vaccine: YF
Symptoms: Injection site pain
Clinical narrative: Had yellow fever vaccine 7/7/07. On 7/10/07 developed soreness and pain from injection site up in Axilla
Age: 65.0
Sex: M
Vaccine: YF, YF
Symptoms: Blister, Erythema, Pain, Pruritus, Skin burning sensation
Clinical narrative: Received yellow fever vaccine 7/5/07, 40 min later developed red, swollen area from index finger to wrist on hand also, red area on side of face. Area on hand started burning. Developed 2-3 reddened area calf of leg the next day. No fever, itching or redness, hand red area become blistered and very painful. No fever also developed red swollen itching patches on scalp. No difficulty breathing. Pt went to ER. hospital on 7/6/07 was given Prednisone and Benadryl for allergic reaction and sent home. By Monday 7/7/07 - all reddened areas were resolving, itching gone, no fever, blisters did not break - resolved spontaneously
Age: 65.0
Sex: M
Vaccine: YF, YF
Symptoms: Swelling
Clinical narrative: Received yellow fever vaccine 7/5/07, 40 min later developed red, swollen area from index finger to wrist on hand also, red area on side of face. Area on hand started burning. Developed 2-3 reddened area calf of leg the next day. No fever, itching or redness, hand red area become blistered and very painful. No fever also developed red swollen itching patches on scalp. No difficulty breathing. Pt went to ER. hospital on 7/6/07 was given Prednisone and Benadryl for allergic reaction and sent home. By Monday 7/7/07 - all reddened areas were resolving, itching gone, no fever, blisters did not break - resolved spontaneously
Age: 65.0
Sex: M
Vaccine: YF, YF
Symptoms: Blister, Erythema, Hypersensitivity, Pain, Pruritus
Clinical narrative: Received yellow fever vaccine 7/5/07, 40 min later developed red, swollen area from index finger to wrist on hand also, red area on side of face. Area on hand started burning. Developed 2-3 reddened area calf of leg the next day. No fever, itching or redness, hand red area become blistered and very painful. No fever also developed red swollen itching patches on scalp. No difficulty breathing. Pt went to ER. hospital on 7/6/07 was given Prednisone and Benadryl for allergic reaction and sent home. By Monday 7/7/07 - all reddened areas were resolving, itching gone, no fever, blisters did not break - resolved spontaneously
Age: 65.0
Sex: M
Vaccine: YF, YF
Symptoms: Skin burning sensation, Swelling
Clinical narrative: Received yellow fever vaccine 7/5/07, 40 min later developed red, swollen area from index finger to wrist on hand also, red area on side of face. Area on hand started burning. Developed 2-3 reddened area calf of leg the next day. No fever, itching or redness, hand red area become blistered and very painful. No fever also developed red swollen itching patches on scalp. No difficulty breathing. Pt went to ER. hospital on 7/6/07 was given Prednisone and Benadryl for allergic reaction and sent home. By Monday 7/7/07 - all reddened areas were resolving, itching gone, no fever, blisters did not break - resolved spontaneously
Age: 62.0
Sex: F
Vaccine: YF
Symptoms: Erythema, Pruritus generalised, Rash erythematous
Clinical narrative: Pt. received only yellow fever vaccine on 7/5/07. Forty minutes later developed reddened raised are on one side of face red area faded after 24 hrs-but pt had itching all over body for 48 hrs-Resolved with medical intervention
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Back pain, Myalgia, Nausea
Clinical narrative: Nausea, muscular pain, weakness, back pain
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: Itch all over-but mostly, itch at base of spine where pt previously had shingles.-No treatment
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: w/in 2 days pt developed small, red, itchy, raised rash to both arms.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Pt developed hives over all her body requiring steroids and Benadryl went to PCP and allergist required high dose  steroids.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Accidental overdose, Inappropriate schedule of drug administration
Clinical narrative: Patient was given a second Menactra injection. Had the first on one on 8-4-05 and another on 7-11-07.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Cold compress therapy, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: pt c/o hard knot in (L) deltoid muscle hot to touch and tender. Vaccine given 6/25/07. Denies streaking and/or fever. Advised to apply ice and take Motrin 600 TID
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Disturbance in attention, Pallor, Vomiting
Clinical narrative: 3 episodes vomiting within minutes of injection accompanied by pallor and inattention. Resolved fully within 20 minutes.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy
Clinical narrative: Information has been received from an 18 year old  female who in 2007 was vaccinated IM with a dose of Gardasil. The patient reported that she is 8 weeks pregnant and received the vaccine. No adverse reaction reported. Follow up information has been received from a physician concerning the 18 year old female with 0 previous pregnancies and no medical history who on 04-JUN-2007 was vaccinated IM with a dose of Gardasil. The patient received an elective abortion at 8 weeks. The elective termination occurred the week of 04-JUN-2007. Upon internal review, elective abortion was considered to be an other important medical event. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Cyanosis, Dizziness, Grand mal convulsion, Loss of consciousness, Myalgia
Clinical narrative: Information has been received from a physician who received a fax from a patient, concerning a female patient who on an unspecified date was vaccinated with Gardasil. Subsequently, following vaccination, the patient became dizzy, her "muscles were heavy", and she lost focus. It was reported that a nurse sat the patient down, however sitting down did not make the symptoms any better. The physician then came into the room and gave the patient a shot of Benadryl. After receiving the Benadryl the patient was placed in another room for a short time. After a couple of minutes, the nurse went back into the room to take the patient's blood pressure and found the patient having a grand mal seizure. The physician again entered the room and found the patient unconscious, not breathing, and her jaw was clamped and her lips were blue. The patient was subsequently hospitalized. At the time of this report, the outcome of the events was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Respiratory arrest, Trismus, Vision blurred
Clinical narrative: Information has been received from a physician who received a fax from a patient, concerning a female patient who on an unspecified date was vaccinated with Gardasil. Subsequently, following vaccination, the patient became dizzy, her "muscles were heavy", and she lost focus. It was reported that a nurse sat the patient down, however sitting down did not make the symptoms any better. The physician then came into the room and gave the patient a shot of Benadryl. After receiving the Benadryl the patient was placed in another room for a short time. After a couple of minutes, the nurse went back into the room to take the patient's blood pressure and found the patient having a grand mal seizure. The physician again entered the room and found the patient unconscious, not breathing, and her jaw was clamped and her lips were blue. The patient was subsequently hospitalized. At the time of this report, the outcome of the events was unknown. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Tremor
Clinical narrative: The evening after receiving shots, developed local redness and swelling at injection sites. Mild fever (100.2), seen at ER for shaking/trembling (not seizure)
Age: 1.0
Sex: F
Vaccine: MMRV, PPV
Symptoms: Blood test, Body temperature increased, Contusion, Inappropriate schedule of drug administration, Rash
Clinical narrative: Patient was given an MMR-V and PNU vaccines Thurs. evening between 4-6:00/pm on 3/1/-7. According to history from her mother, pt was first noticed to have a "few spots on her front and back" Sunday evening 3/4/07 By Monday 3/5/07 she had lots of spots. Tuesday AM 3/6/07 she was covered with a rash from her knees to her armpits Tuesday they took her to see their doctor and were informed it was from her immunization-a reaction. Blood work was ordered and completed. Her temperature peaked at 100 deg. Rash continued for a week, then had purple bruising that faded gradually but could return occasionally. Within 2 wks, all symptoms were gone. Mother said two medications were given.
Age: 1.0
Sex: F
Vaccine: MMRV, PPV
Symptoms: Skin discolouration, Vaccination complication
Clinical narrative: Patient was given an MMR-V and PNU vaccines Thurs. evening between 4-6:00/pm on 3/1/-7. According to history from her mother, pt was first noticed to have a "few spots on her front and back" Sunday evening 3/4/07 By Monday 3/5/07 she had lots of spots. Tuesday AM 3/6/07 she was covered with a rash from her knees to her armpits Tuesday they took her to see their doctor and were informed it was from her immunization-a reaction. Blood work was ordered and completed. Her temperature peaked at 100 deg. Rash continued for a week, then had purple bruising that faded gradually but could return occasionally. Within 2 wks, all symptoms were gone. Mother said two medications were given.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Hyperlipidaemia, Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Local swelling at injection site (R) deltoid erythema with warmth at and below site rash approx 10 x 12 cm no lymphadenopathy, lymphangitis, fever
Age: 23.0
Sex: F
Vaccine: PNC
Symptoms: Injection site warmth, Pain, Tenderness
Clinical narrative: Left upper arm is very tender, hurts to raise arm up. Mild hear at injection site. Pt applied heart to area, then cool compresses.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient's mother c/o "prolonged reaction" to Varicella #2 after 6 days. Reaction appear with erythema on area of Approx 10x12 mm, no induration or increased temp on area, no pain.
Sex: U
Vaccine: VARCEL
Symptoms: Cellulitis
Clinical narrative: Went to ER. diagnosed with cellulitis
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis
Clinical narrative: Seen in ER on 7/1/07 diagnosed with cellulitis.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Dyspnoea, Eyelid oedema, Injection site erythema, Injection site swelling, Oedema mouth
Clinical narrative: Erythema and swelling at vaccine site. Eyelid and mouth swelling x several days and wheezing with shortness of breath.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Wheezing
Clinical narrative: Erythema and swelling at vaccine site. Eyelid and mouth swelling x several days and wheezing with shortness of breath.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Pruritus generalised, Rash generalised
Clinical narrative: Varicella Lot #0518U 13.09 given R arm MMR Lot # 1029418 18.08 given L arm 10:40 AM T. 96-4 11:30 AM Mom returns to office with child red-itchy rash all over her body. Scalp the worse. Benadryl 1 1/2 tsp given and transported to ER. for evaluation and IV therapy.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site oedema
Clinical narrative: Day after admin varicella vaccine on R arm elbow and forearm presented with edema - site of injection is clear, was never red nor swollen nor itchy per child and mom. Advised to take child to ped Dr and apply cold compress to swollen area until seen by MD today, 6/29/07 4P. 7/2/07 as per mom Dr could not find anything wrong and was told to get over the counter Benadryl.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: Varivax given L arm SQ
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling at site x2 days, sl tenderness, warmth, no induration, site approx 3cm x 6 cm. Pt well appearing, cool compress, ibuprofen advised.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: 1 Day following vaccine administration, pt reports itchy, red area around site. 3 days after injection, in clinic with itchy, red area (1 inch diameter), sl warm to touch.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Local reaction immunization site 4cm redness and induration within minutes of Varivax dose, treated w/oral Benadryl and cool compress
Age: 6.0
Sex: F
Vaccine: DTAP, HEPA, IPV, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: marked swelling, redness, tenderness shoulder to mid forearm after receipt Dtap #3 RX ibuprofen, cool soaks.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Chest pain, Eyelid oedema
Clinical narrative: <1 hr after Varivax given eyelid swelling and chest pain; no hives or wheezing better after Benadryl 1; 1 dos oral Prednisone also given for treatment.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Local reaction, Oedema peripheral
Clinical narrative: Positive local reaction with erythema, swelling of arm.
Age: 7.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Hypersensitivity, Swelling face, Vomiting
Clinical narrative: 1 hr after receiving vaccinations, patient began vomiting and experiencing facial swelling. Went to ER - dx with acute allergic reaction - treated with Benadryl G 1-2 hrs.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: On 7-3-07 client received MMR 3 Dtap with 100 pm. that evening client arm got red and itching. Fever 995 Tylenol given. Mom put ice on arm 7/3/07 pm and 7//7/07. Red area on L upper arm measured 3"x2 1/2".
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Pain
Clinical narrative: 1 day after vaccine was administered, pt developed redness, pain and swelling at injection site. Day 2 the area of erythema, induration measured 2x3 inches. Pt complained of pain.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Pain, Pruritus
Clinical narrative: 1 day after immunization, patient had an area of erythema and induration on L upper arm measuring 4x4". Also complained of pain and itchiness.
Age: 6.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: Patient given adult dose of Hepatitis A vaccine, not pediatric. Have left several messages at home and family has not returned calls.
Age: 1.3
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Redness and swelling noted ab 27-28 hours after vaccination. Diameter 1.5", increasing Dtap L arm - upper, PCV 7 R arm - lower on 06-22-07 to about 2" resolved on 06-24-07, mild tenderness no fever.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema
Clinical narrative: Redness < 1" started ab 27-28 hours after vaccination. No fever, no tenderness/resolved on 06-23-07.
Age: 1.0
Sex: M
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Body temperature increased, Erythema, Rash
Clinical narrative: 100 deg F with rash (red spots) on face and hands looks ill.
Sex: F
Vaccine: DTAP, HEPA, IPV, VARCEL
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Redness, warmth, swelling itching
Age: 0.8
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, Medication error, Wrong drug administered
Clinical narrative: Pt was inadvertently given Hep A before the appropriate age of 12 mos. Pt was scheduled for Hep B #3.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema
Clinical narrative: Pt was given her 1st/Hep B series vaccine, pt reports that her arm became red from injection site to her elbow approx 2-3 hours after injection lasting approx 2 days. No rash or SOB. Pt reports history of many allergies as a child. No latex allergy.
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Cellulitis, Erythema, Skin warm, Swelling
Clinical narrative: Cellulitis - warm, redness, swelling left posterior thigh Tx with 2 gram Rocephin IM injection and Clindamycin 75/5 15 ml TID x 10 days.
Age: 14.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Right arm, red swollen - Keflex and Benadryl
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine site swollen and warm to touch. Redness at site - taking Ceflin and Benadryl
Age: 38.0
Sex: F
Vaccine: TTOX
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Reddish, raised softball size area. Warm to touch.
Age: 12.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Full blood count normal, Lumbar puncture, Muscular weakness, Neuropathy, Nuclear magnetic resonance imaging brain normal
Clinical narrative: 1. Winging of right scapular secondary to right long thoracic neuropathy of demyelinating type 5/16/07. 2. Weakness left leg - atrophy same time period. 3. Right foot tremor 5/31/07 ----> resolved 6/11/07.
Age: 12.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Red blood cell sedimentation rate normal, Tremor
Clinical narrative: 1. Winging of right scapular secondary to right long thoracic neuropathy of demyelinating type 5/16/07. 2. Weakness left leg - atrophy same time period. 3. Right foot tremor 5/31/07 ----> resolved 6/11/07.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Barium enema, Central venous catheterisation, Colostomy, Diarrhoea, Endotracheal intubation
Clinical narrative: Information has been received from the FDA (VAERS # 279026) through the CDC concerning a 14-week-old male who on 08-MAY-2007 was vaccinated with a first dose of Rotateq (Lot # 656102/1165F). On 13-MAY-2007 the patient experienced intussusception. A gut resection was done. A standard lot check investigation was performed for Lot # 656102/1165F). 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 for Biologics Evaluation and Research and was released. Upon internal review, intussusception was considered to be an other important medical event. Additional information has been requested.