chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug administration error, Premature baby, Unintended pregnancy
Clinical narrative: Information has been received from a physician through the pregnancy registry concerning a 33 year old female with a history of sinusitis and no known drug allergies who on 4/29/02 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy included acetaminophen/pseudoephedrine HCl that was used twice during the past month. On 5/8/02 it was reported that the patient is now pregnant with her LMP 4/8/02. Her estimated delivery date was determined to be 1/13/03. Unspecified medical attention was sought. On 5/10/02 it was reported that the physician will not be following the patient's pregnancy. On 5/13/03, it was reported that the physician did not have any pregnancy outcome information and had only seen the patient in the clinic one time. On 5/16/03 information was received from the physician who had spoken to the patient's husband (the patient was out of the country). It was reported that on 10/29/02 at 29 weeks gestation the patient delivered an approximately 3lb 6oz infant. It was reported that there was no infection and that the baby was hospitalized for 2 months to grow and is doing well now. Upon internal review, the patient delivered at 29 weeks gestation was determined to be an other important medical event (OMIC). No further information is available.
Sex: M
Vaccine: OPV
Symptoms: Dyspnoea, Lung neoplasm malignant
Clinical narrative: A legal complaint was received from an attorney regarding an adult male. The plaintiff's history includes exposure to asbestos and asbestos-containing products. According to the legal complaint, sometime in the 1950's or 1960's, the plaintiff was administered OPV or IPV. In October 2001, the plaintiff was reportedly diagnosed with mesothelioma. The legal complaint states that the plaintiff's exposure to asbestos, asbestos-containing products, and the SV40 virus caused severe and permanent injury to the plaintiff including, but not limited to breathing difficulties, asbestosis, lung and/or other cancer, mesothelioma, and/or other lung damage. The legal complaint states that the plaintiff stopped working on 11/23/01 due to his mesothelioma.
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Convulsion, Epilepsy, Laboratory test abnormal, Staring
Clinical narrative: This report described the occurence of possible epilepsy in a 12 month old female who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined for prophylaxis. This report was received from the subject's mother and has not been verified by a physician or other healthcare professional. The subject was adopted in March 2003; her medical history was not available. Concurrent conditions and medications were not reported. The subject was reportedly immunized prior to adoption. However, because immunization records were not available, the childhood immunization schedule was repeated. On 5/23/02, the subject received her first injection of Pediarix; this was the second dose in the immunization series against diphtheria, tetanus, pertussis, hepatitis B and poliomyelitis. On 5/23/03, the subject also received injections of Haemophilus influenzae type B conjugate vaccine and 7-valent pneumococcal conjugate vaccine. On 5/26/03, three days post immunization, the subject reportedly had a seizure. The mother stated that the subject was not there. When she finally did come to, the child just had a blank stare for a while. The subject was taken to the local emergency room. Unspecified lab analyses and computed tomography of the brain were performed. Reportedly, the CT revealed a calcium deposit on the subject's brain that was probably from a previous infection. Emergency room physicians reportedly think she has epilepsy. The subject was referred to a neurologist. The seizure resolved on 5/26/03. The outcome of the possible epilepsy was unknown as of 5/28/03. Seizure and possible epilepsy are considered to be medically serious (OMIC).  Received on 06/16/2003: "On 05/29/2003, the subjects mother provided the lot number of pediarix that had been administered."  Follow up on 07/11/2003: "The physician indicated that the initial seizure resolved with unspecified sequelae on 05/26/2003.  The physician considered the possible epilepsy and seizure to be serious because they jeopardized the patient or required intervention.  The physician considered the events to be possibly related to Pediarix administration or to the old hemorrhage or infection detected on head CT.  Seizure and possible epilepsy are considered to be medically serious."
Age: 47.0
Sex: F
Vaccine: HEPA
Symptoms: Cough, Dehydration, Dizziness, Myalgia, Nasal congestion
Clinical narrative: A physician reported the occurrence of a dry cough in a 47 year old female who was vaccinated with hepatitis A vaccine inactivated for prophylaxis. The subject's medical history and concurrent conditions were not reported. The subject was described as being otherwise healthy. Surgical history included hysterectomy. The subject received no concurrent medications or vaccines. In March 2003, the subject received her first injection of Havrix. Twenty four hours post-immunization, she developed fevers as high as 102.2 degrees F, an extremely dry cough, a lot of nausea, dizziness, itching on the soles of her feet, myalgia, chest congestion, wheezing, tachycardia, and dehydration. The subject was seen by the physician. A complete blood count with differential was performed on 3/20/03; results were within the reference ranges. The physician noted that the subject had a history of recent travel and may have been exposed to severe acute respiratory syndrome. As of 3/21/03, the events had improved, but the subject still had a dry cough. The most recent information received was received on 5/20/03. The physician stated that she considered the events to be possibly related to the recent travel. However, the Havrix immunization series was discontinued. The physician also indicated that she considered the events to have placed the subject in jeopardy or to have required intervention. Therefore, this report has been reclassified as serious.
Age: 47.0
Sex: F
Vaccine: HEPA
Symptoms: Nausea, Pruritus, Pyrexia, Tachycardia, Wheezing
Clinical narrative: A physician reported the occurrence of a dry cough in a 47 year old female who was vaccinated with hepatitis A vaccine inactivated for prophylaxis. The subject's medical history and concurrent conditions were not reported. The subject was described as being otherwise healthy. Surgical history included hysterectomy. The subject received no concurrent medications or vaccines. In March 2003, the subject received her first injection of Havrix. Twenty four hours post-immunization, she developed fevers as high as 102.2 degrees F, an extremely dry cough, a lot of nausea, dizziness, itching on the soles of her feet, myalgia, chest congestion, wheezing, tachycardia, and dehydration. The subject was seen by the physician. A complete blood count with differential was performed on 3/20/03; results were within the reference ranges. The physician noted that the subject had a history of recent travel and may have been exposed to severe acute respiratory syndrome. As of 3/21/03, the events had improved, but the subject still had a dry cough. The most recent information received was received on 5/20/03. The physician stated that she considered the events to be possibly related to the recent travel. However, the Havrix immunization series was discontinued. The physician also indicated that she considered the events to have placed the subject in jeopardy or to have required intervention. Therefore, this report has been reclassified as serious.
Age: 1.5
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Myelitis transverse, Paresis
Clinical narrative: 5/22/03 two days post vaccine pt developed transverse myelitis, confirmed by MRI C2-C6 with dense quadriparesis. Gradual improvement in progress. All cultures negative. Presumed viral etiology. Inf. disease specialists do not believe it is vaccine related.
Age: 63.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Joint stiffness
Clinical narrative: Approximately 4 to 6 months after the 2nd 30 day shot I experienced severe pain and stiffness in my right knee joint. This seemed to subside and then in about 6 months the same thing happened to my left hip joint and then my right shoulder joint and eventually to my left hip joint, again.
Age: 1.3
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Aphasia, Autism, Oral intake reduced
Clinical narrative: Stopped babbling, stopped eating regular foods, ignored parents when name was called. This started sometime between 12-17 months of age. Had been saying some one word things. 06/12/2003: "Onset of autistic symptoms. Diagnosis: Autism Spectrum Disorder."
Age: 0.75
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Screaming
Clinical narrative: Crying for 3 days after 4m vaccines. High/low pitched.
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Red, swollen area at injection site - 10 x 12 cms, 24 hours post injection of left arm.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Left leg with 10.5 cm x 17 cm area of erythema and edema - suggested they could try Benadryl. Started 1 day after vaccination.
Age: 44.0
Sex: F
Vaccine: TD
Symptoms: Diarrhoea, Injection site erythema, Injection site oedema, Muscle spasms, Pyrexia
Clinical narrative: Had adult Td on 5/19/03 after a dog bite. Approx 24 hours later started having muscle cramping in legs and feet. Vomiting and diarrhea, "fever", then asthma-like symptoms. Resolved with Benadryl every 4 hours. Now red swollen area on left arm at site of injection, "size of a softball". Allergic to PCN/morphine.
Age: 44.0
Sex: F
Vaccine: TD
Symptoms: Vomiting
Clinical narrative: Had adult Td on 5/19/03 after a dog bite. Approx 24 hours later started having muscle cramping in legs and feet. Vomiting and diarrhea, "fever", then asthma-like symptoms. Resolved with Benadryl every 4 hours. Now red swollen area on left arm at site of injection, "size of a softball". Allergic to PCN/morphine.
Age: 55.0
Sex: F
Vaccine: TYP
Symptoms: Myalgia, Pain
Clinical narrative: 5/11/03: "Run-down, achey feeling". 5/13/03: "Felt better". 5/14/03: "Pulled muscle" in chest area.
Age: 2.9
Sex: M
Vaccine: DTAP, HEPA, PNC
Symptoms: Erythema, Petechiae, Pruritus, Urticaria
Clinical narrative: Urticaria-type red rash with no blistering, red and itchy on both legs (knee to hip); few scattered petechiae over trunk front and back; few on back of neck.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Oedema, Pain
Clinical narrative: Began experiencing edema and arthalgia (severe) in bilateral lower legs and right arm. Injection given in left arm. Seen at Health Center 5/27/03 and placed on Celebrex. Now edema has subsided but still complains of right arm pain with sensation. HS is better, but not completely resolved.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Redness and swelling left arm 13 cm length. Left arm 21.5 cm circumference, right arm 20 cm circumference.
Age: 1.7
Sex: M
Vaccine: PNC
Symptoms: Erythema, Oedema
Clinical narrative: Red, swollen left leg.
Age: 0.6
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Nasal congestion, Pyrexia, Rash
Clinical narrative: B/L rash - thighs around shot, larger than 50 cent piece for one week. Has not seen MD, now has runny nose, green mucous Sat AM, off and on temp. Mom will call if she takes child to the MD.
Age: 32.0
Sex: F
Vaccine: TD, TYP
Symptoms: Dysphonia, Dyspnoea, Vocal cord paralysis
Clinical narrative: Pt received Tetanus diphtheria booster on morning of 4/24/03; within 12 hours she experienced increasing hoarseness in her voice. Seen by our FNP that PM and again 4/30/03 for feeling of shortness of breath as well. Pt referred to ENT who did laryngoscopy finding paralysis of right vocal cord - he scheduled CT - negative findings. Pt also referred to GI to consider GERD.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Erythema, Urticaria
Clinical narrative: Red face, hives. Advised Benadryl 3/4 tsp on 5/21/03 - continue 9 times, every 6 hours until no hives at 24 hours. All hives gone by next morning.
Age: 1.25
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Agitation, Crying, Injection site erythema, Injection site oedema, Rash
Clinical narrative: 6 days following immunization started waking at night, crying, agitated. On 7th day, rash lower back. On day 9, rash at injection site, 2.5 cm of edema, erythema and excoriations.
Age: 1.25
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Sleep disorder
Clinical narrative: 6 days following immunization started waking at night, crying, agitated. On 7th day, rash lower back. On day 9, rash at injection site, 2.5 cm of edema, erythema and excoriations.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Pruritus, Tenderness
Clinical narrative: DTaP given on 5/27/03 left thigh. Left thigh red, swollen, tender and hot and itching. Redness measures 120 mm x 100 mm. Gave Keflex po for possible cellulitis. Gave Benadryl for vaccine reactions.
Age: 17.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Dysphemia, Eye movement disorder, Loss of consciousness
Clinical narrative: Student received Hep A #1 vaccine, turned to sit with received Hep B #2 in opposite arm (right arm). Injection of Hep B, pt began to stutter, eyes rolled back, he lost consciousness, was assisted to the floor. Regained consciousness. Oxygen mask applied. U/S affected. BP 110/60. Rested, food given, parent called.
Age: 40.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Arthritis, Fatigue
Clinical narrative: Joint inflammation and pain, fatigue. Treated with antiflammatory meds.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Stupor
Clinical narrative: Per mother, pt was eating cookie, seemed to be in a daze and appeared she was not breathing, cookie in back of throat - removed. Tempt 101.8. Mother states has had 4 episodes of dozing off while watching TV - no body movements.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Red, hot swollen area to upper left deltoid. Prescribed Benadryl PRN and Augmentin 400/5 tsp BID for 10 days.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: 5 x 4 cm mildly erythematous, not war and tender, area around injection site, no skin breakdown.
Age: 0.5
Sex: F
Vaccine: DTAP
Symptoms: Vomiting
Clinical narrative: Immunizations at 2 and 4 month - 3 hour screaming spell. Immunizations at 6 months - vomiting. All episodes occurred about 6-8 hours after shots.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Swelling and redness in left leg, above and below knee, with inflammation of knee - painless, began approx. 3 hours after vaccination and symptoms decreasing with time. According to mom, advised family to follow up visit with MD 5/17/03 if symptoms persist, no restrictions on activity upon discharge.
Age: 0.8
Sex: F
Vaccine: IPV, PNC
Symptoms: Unevaluable event
Clinical narrative: Prevnar #4 given at 9 months old - no adverse reaction reported from parents.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Screaming
Clinical narrative: Uncontrollable crying for 3 hours straight. DTaP shot was administered 6:30 PM on 5/29/03. Reaction occurred around 4:30 PM 5/31/03.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Fontanelle bulging, Irritability, Pyrexia
Clinical narrative: Developed irritability (mild), low grade fever (100.7) and a bulging tense fontanelle 24 hours after immunizations.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: RED, HOT TO HOUCH, SWOLLEN. AUGMENTIN 600MG ES
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Abscess
Clinical narrative: PATIENT HAD ABSCESS LATERAL TO SMALLPOX SITE 3 WEEKS AFTER IMMUNIZATION. ALSO MARKED ABSCESS ON LEFT INNER ARM AND RIGHT INNER THIGH
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Rash, Vomiting
Clinical narrative: Vaccinations of DTaP, IPV & MMR around 0830.  Returned to health dept @ 1030.  Child with rash (raised & pink) on trunk of body & around neck.  1 episode of vomiting.  Sent straight to ER at hospital.  Benadryl and steroids in ER.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Pigmentation disorder, Rash erythematous
Clinical narrative: Parent states had large red area left mid-thigh after injections 2/20/03.  After red area went down and impression was left to left mid-thigh area.  Area noted 5/30/03 to measure 1cm x 2cm with some loss of pigment to area.  Mother had called doctor and was instructed was ok, just to watch.  Mother took child to clinic and was seen by clerical staff and told was ok.  Mother saw another doctorwith child and was referred to health department for documentation of area.  Mother unsure of time of visit and how soon reaction started with reddness of area.  We have pictures of area if needed.
Age: 31.0
Sex: F
Vaccine: YF
Symptoms: Injection site urticaria
Clinical narrative: Urticaria at injection site within two minutes, received po benadryl.  No wheezing, no hypotension, no other rash noted.  Patient's symptoms began to abate within one hour
Age: 50.0
Sex: F
Vaccine: SMALL
Symptoms: Demyelination, Dizziness, Ear pain, Hypoacusis, Otitis media
Clinical narrative: 5 days after I had the vaccine, I developed an earache and fever.  I went to my doctor, he said I had otitis media in my left ear.  He treated me with an antibiotic.  I returned two more times to him due to the pain.  I have no other hx of ear infection.  He referred me to an ENT as I was losing my hearing, felt dizzy.  The other doctor said I no longer had an infection and tested my hearing and I had some deafness in my left ear (I had no trouble hearing prior to vaccination).  In a couple of weeks, I return to the specialist and I told him that the pain and deafness was gone.  He wanted a MRI to r/o a brain tumor.  I had the MRI and it suggests demyeinating disease.  I will see a neurologist in about 1 week.  I wonder if the ear infection, deafness, and lesions of white matter on MRI could be related to the vaccine.  Did this happen to anyone else?  Thank you.
Age: 50.0
Sex: F
Vaccine: SMALL
Symptoms: Pyrexia
Clinical narrative: 5 days after I had the vaccine, I developed an earache and fever.  I went to my doctor, he said I had otitis media in my left ear.  He treated me with an antibiotic.  I returned two more times to him due to the pain.  I have no other hx of ear infection.  He referred me to an ENT as I was losing my hearing, felt dizzy.  The other doctor said I no longer had an infection and tested my hearing and I had some deafness in my left ear (I had no trouble hearing prior to vaccination).  In a couple of weeks, I return to the specialist and I told him that the pain and deafness was gone.  He wanted a MRI to r/o a brain tumor.  I had the MRI and it suggests demyeinating disease.  I will see a neurologist in about 1 week.  I wonder if the ear infection, deafness, and lesions of white matter on MRI could be related to the vaccine.  Did this happen to anyone else?  Thank you.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Abscess
Clinical narrative: PATIENT HAD ABSESS MSRA POSTITIVE AT SMALLPOX SITE
Age: 1.2
Sex: M
Vaccine: DTAP, HBHEPB, MMR, PNC, VARCEL, DTAP, HBHEPB, MMR, PNC, VARCEL
Symptoms: Crying, Erythema, Oedema
Clinical narrative: Within 10 seconds of receiving MMR and Varicella, both arms of patient became red and swollen.  The child began pulling at his arms and crying.  Dr. was notified and patient was givne benedryl 5cc prostat
Age: 1.2
Sex: M
Vaccine: DTAP, HBHEPB, MMR, PNC, VARCEL, DTAP, HBHEPB, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Within 10 seconds of receiving MMR and Varicella, both arms of patient became red and swollen.  The child began pulling at his arms and crying.  Dr. was notified and patient was givne benedryl 5cc prostat
Age: 1.2
Sex: M
Vaccine: DTAP, HBHEPB, MMR, PNC, VARCEL, DTAP, HBHEPB, MMR, PNC, VARCEL
Symptoms: Crying, Erythema, Oedema
Clinical narrative: within 10 seconds of receiving mmr and varicella both arms began to swell and turn red.  child adminsitered benedryl and watched for 20 minutes after.
Age: 1.2
Sex: M
Vaccine: DTAP, HBHEPB, MMR, PNC, VARCEL, DTAP, HBHEPB, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: within 10 seconds of receiving mmr and varicella both arms began to swell and turn red.  child adminsitered benedryl and watched for 20 minutes after.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Pruritus, Rash erythematous
Clinical narrative: 4:10 pm on 5/22/03, patients mother stated raised red area with itching instructed to apply qwarm compresses.  5/26/03 mother said patient fine
Age: 23.0
Sex: M
Vaccine: HEPA, SMALL, TYP
Symptoms: Chest pain, Dyspnoea, Hyperhidrosis, Nausea, Pain
Clinical narrative: Substernal Chest Pain 8 days s/p Vaccine with assoc dyspnea, n/v, diaphoresis and radiation of pain to left axilla and jawà ER  lumbar puncture done = negative à  treated and released à10 days s/p áchest pain à ERàHospitalized
Age: 23.0
Sex: M
Vaccine: HEPA, SMALL, TYP
Symptoms: Vomiting
Clinical narrative: Substernal Chest Pain 8 days s/p Vaccine with assoc dyspnea, n/v, diaphoresis and radiation of pain to left axilla and jawà ER  lumbar puncture done = negative à  treated and released à10 days s/p áchest pain à ERàHospitalized
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Rash pustular
Clinical narrative: AREA OF ERYTHERMA WTIH SMALL PUSTULAR FLECKS
Age: 0.5
Sex: F
Vaccine: DTPHIB, MMR
Symptoms: Antisocial behaviour, Autism, Loss of consciousness, Neurodevelopmental disorder
Clinical narrative: after shots patient was lathergic almost unconcious for 72 hours, Dr.'s office when called said it was a common side affect and not to worry....patient never seemed the same again has had mild autistic like symptoms learning disabled and communication problems
Age: 29.0
Sex: M
Vaccine: SMALL
Symptoms: Vaccination complication
Clinical narrative: SMALL SINGLE AUTO INOCULATION BULLA ON LEFT SHOULDER
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Injection site reaction, Laboratory test abnormal, Pyrexia
Clinical narrative: Febrile illness an robust local reaction within 3 days of vaccination; Pleuritic pain 7 days s/p vaccine; Hospitalized with ácardiac enzymes, abnormal ECG and ECHO 10 days s/p vaccination
Age: 39.0
Sex: M
Vaccine: SMALL
Symptoms: Chest discomfort, Dyspnoea, Laboratory test abnormal, Palpitations
Clinical narrative: Patient is a 39 y.o. male nurse employed at a hospital.  Not diagnosed with HTN, but states his diastolic pressure has been in the 90's for the last 2-3 months (from his doctor's records, at one visit his BP ws 132/80 and 144/84), last cholesterol was 256, no diabetes, non-smoker, no family hx of cardiac disease.  He was vaccinated on 5/8/03, on 5/11/03 he developed  SOB with exertion.  On 5/12 during heated union negotiations he developed a few seconds of palpitations and chest tightness.  He then walked up and down stairs and felt quite SOB.  On 5/13 he went to the ER on the suggestion of a colleague. Per patient report, in the ER his BP was 140/110, O2 sat at rest was 94%, ABG showed a "moderate" A-a gradient with a PO2 of 88.  CXR was negative, Chest CT (pulmonary angiogram protocol) was negative for pulmonary embolization, EKG had non-significant ST elevations (per patient), CK and troponin were negative, ECHO was negative.  On 5/15 he had a negative stress thallium.  By 5/20 his SOB was almost resolved, v. slight SOB on exertion only, by 5/28 his symptoms were totally resolved.  He had a similar episode 3 yrs ago with a few seconds of palps/SOB while at court with his mother (feeling stressed/anxious), stress thall at that time was negative. PMD saw him for follow up, did not recommend any further pulmonary work up, for his "borderline" BP and high cholesterol, just recommended weight loss.  I am still waiting for ER records.  Lab results showed ABG: pH 7.44, PaCO2 37.2, PaO2 83, HCO3 25.8, O2Sat 97
Age: 11.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Information has been received from a nurse concerning an 11 year old male who on 09/17/2001 was vaccinated with a dose of hepatitis A vaccine (inactive) (lot #639764/0687L).  On 09/17/2001, "that same evening", the patient developed hives.  The patient was taken to an emergency room, and was treated with the following:  methylprednisolone sodium succinate (SOLU-MEDROL), 60mg; prednisone 20mg; diphenhydramine HCL (Benadryl), 25mg, ever five hours.  It was unknown if the patient was hospitalized.  The nurse reported that the patient was also treated with fexofenadine HCL (Allegra).  The patient underwent follow-up tests in November 2001, December 2001 and January 2002, which included the following: component C3 normal; component C4 normal; "CDC" normal; hepatic function tests normal; thyroid-stimulating hormone (TSM) normal; immunoglobulin M (IgM) non-reactive; hepatitis B surface antigen non-reactive; hepatitis A antibody non-reactive; antinuclear antibodies (ANA) positive; Epstein-Barr virus antibodies normal; "OMP" negative.  The nurse reported that the patients hives have contined "since time of vaccination till at least September 2002".  Additional information has been requested.
Age: 3.1
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Hypersensitivity, Oedema, Pyrexia, Urticaria
Clinical narrative: Information has been received from a physician concerning a 40 month old male with asthma who on 07/17/2002 at 13:30 was vaccinated intramuscularly in the right arm with the first dose of hepatitis A virus vaccine inactivated (lot # 642625/0169M).  Illness at time of vaccination included an upper respiratory tract infection.  There were no adverse events following prior vaccination.  On 07/17/2002, at 17:00, the child developed hives which spread during the next three days from the back to the chest and then over the complete body.  It was reported that the hives "waxed and waned".  The child was treated with cetirizine hydrochloride (Zyrtec) and diphenhydramine hydrochloride (Banadryl).  On 08/06/2002, the child's condition progressed to serum sickness with fever to 101 F, hives, and joint swelling.  Unspecified medical attention was sought.  A complete blood count and erythrocyte sedimentaion rate were found to be normal.  The child subsequently recovered by 08/13/2002.  No further information is available.
Age: 3.1
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Joint swelling, Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning a 40 month old male with asthma who on 07/17/2002 at 13:30 was vaccinated intramuscularly in the right arm with the first dose of hepatitis A virus vaccine inactivated (lot # 642625/0169M).  Illness at time of vaccination included an upper respiratory tract infection.  There were no adverse events following prior vaccination.  On 07/17/2002, at 17:00, the child developed hives which spread during the next three days from the back to the chest and then over the complete body.  It was reported that the hives "waxed and waned".  The child was treated with cetirizine hydrochloride (Zyrtec) and diphenhydramine hydrochloride (Banadryl).  On 08/06/2002, the child's condition progressed to serum sickness with fever to 101 F, hives, and joint swelling.  Unspecified medical attention was sought.  A complete blood count and erythrocyte sedimentaion rate were found to be normal.  The child subsequently recovered by 08/13/2002.  No further information is available.
Age: 3.1
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Hypersensitivity, Oedema, Pyrexia, Urticaria
Clinical narrative: Information has been received from a physician concerning a 40 month old male who on 07/17/2002 was vaccinated with a 0.5ml dose of hepatitis A virus vaccine inactivated (lot # 641124/1395L).  Three hours post-vaccination, on 07/17/2002, the patient developed a whole body rash.  On unspecified dates the patient also developed a fever of 101 degrees and joint swelling.  A "final check" by the physician on 08/13/2002 indicated that the patient had "made a full recovery".  Additional information has been requested.
Age: 3.1
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Joint swelling, Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning a 40 month old male who on 07/17/2002 was vaccinated with a 0.5ml dose of hepatitis A virus vaccine inactivated (lot # 641124/1395L).  Three hours post-vaccination, on 07/17/2002, the patient developed a whole body rash.  On unspecified dates the patient also developed a fever of 101 degrees and joint swelling.  A "final check" by the physician on 08/13/2002 indicated that the patient had "made a full recovery".  Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: FLU3, HEP, HEPA
Symptoms: Pruritus, Urticaria
Clinical narrative: Information has been received from a physician and a nurse concerning a 13 year old white male with a history of truncus arteriosus persistent who on 10/17/2002 was vaccinated with the first doese of hepatitis A virus vaccine inactivated given intramuscularly in the right arm (lot #643695/0989M).  Concomitant therapy, that same day, included the third dose of hepatitis B vaccine recombinant (yeast) given intramuscularly in the right arm (lot # 642483/0008M) and the seventh dose of influenza virus vaccine given intramuscularly in the left arm (lot # U0885AA).  On 10/19/2002 the patient developed hives and itching all over.  It was noted there were no laboratory tests performed and the patient did not have an illness at the time of vaccination.  The physician also provided information regarding other patients (WAES#0210USA02857 & 0210USA02798).  The reporter expressed a concern regarding the lot number.  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  This lot complies with the standards of the Center for Biologics and Research and was released.  The patient required a visit to his physician.  No further information is available.
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Asthenia, Diarrhoea, Fatigue, Urticaria
Clinical narrative: Information has been received from a physician and a registered nurse concerning a 13 year old white female with allergic rhinitis nos who on 10/17/2002 was vaccinated with a dose of hepatitis A virus vaccine inactivated given intramuscularly in the left deltoid (lot # 643695/0689M).  There was no illness at the time of vaccination.  In October 2002 the patient experienced tiredness and felt weak.  On 10/19/2002 the patient developed diarrhea and hives.  Subsequently, the patient recovered from her diarrhea and hives.  Stool tests and culture were ordered but as of 11/27/2002 results had not been received.  The physician also provided information regarding other patient's (WAES#0211USA00109 AND WAES#02100USA02798).  The reporter expressed a concern regarding the lot number.  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  This lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  The patient sought unspecified medical attention.  No further information is available.
Sex: U
Vaccine: IPV, OPV
Symptoms: Dyspnoea, Lung neoplasm malignant, Neoplasm malignant
Clinical narrative: A legal complaint was received from an attorney regarding an adult female. The decedent's history includes exposure to asbestos and asbestos-containing products. According to the legal complaint, "sometime in the 1950's, the decedent was administered OPV or IPV." In July 2001, the decedent was reportedly diagnosed with mesothelioma. On 8/21/01, a thoracotomy and biopsy were performed. The legal complaint states that the "decedent's exposure to asbestos, asbestos-containing products, and the SV40 virus caused severe and permanent injury to the plaintiff including, but not limited to breathing difficulties, asbestosis, lung and/or other cancer, mesothelioma, and/or other lung damage." On 6/21/02, she died. The death certificate lists the immediate cause of death as metastatic mesothelioma due to asbestos exposure.
Sex: U
Vaccine: IPV, OPV
Symptoms: Dyspnoea, Lung disorder, Neoplasm malignant
Clinical narrative: A legal complaint was received from an attorney regarding an adult female. The decedent's history includes exposure to asbestos and asbestos-containing products. According to the legal complaint, "sometime in the 1950's, the decedent was administered OPV or IPV." In July 2001, the decedent was reportedly diagnosed with mesothelioma. On 8/21/01, a thoracotomy and biopsy were performed. The legal complaint states that the "decedent's exposure to asbestos, asbestos-containing products, and the SV40 virus caused severe and permanent injury to the plaintiff including, but not limited to breathing difficulties, asbestosis, lung and/or other cancer, mesothelioma, and/or other lung damage." On 6/21/02, she died. The death certificate lists the immediate cause of death as metastatic mesothelioma due to asbestos exposure.
Sex: F
Vaccine: MMR
Symptoms: Abortion spontaneous
Clinical narrative: Information has been received from a registered nurse concerning a female pt who on 8/28/02 was vaccinated with a dose of MMR II, "at which time the pt stated she was not pregnant." It was noted that the "pt called and reported that she was pregnant when she received the immunization." On 11/14/02, "one of the nurses called the pt and the pt reported she had a miscarriage." The cause of death was miscarriage. The nurse also reported on another pt who received varicella vaccine live during pregnancy (WAES0205USA02764). Additional info has been requested.
Age: 8.0
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a mother concerning her 8 year old son who was vaccinated with a dose of MMR II. Subsequently the pt developed autism. Unspecified medical attention was sought. It was unknown if a prescription drug was required. The pt's autism persisted. It was noted that the pt had all of the required immunizations. It was also noted that the pt's brother, 3 years old, developed signs of autism following vaccinations with diphtheria toxoid/pertussis vaccine/tetanus toxoid and poliovuris vaccine inactivated. Upon internal review, autism was determined to be an other important medical event (OMIC). The reporter indicated that her other 6 year old son had autism after receiving all of the required immunizations (WAES0305USA02845). Additional info has been requested.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a mother concerning her 6 year old son who was vaccinated with a dose of MMR II. Subsequently the pt developed autism. Unspecified medical attention was sought. It was unknown if a prescription drug was required. The pt's autism persisted. It was noted that the pt had all of the required immunizations. It was also noted that the pt's brother, 3 years old, developed signs of autism following vaccinations with diphtheria toxoid/pertussis vaccine/tetanus toxoid and poliovirus vaccine inactivated. Upon internal review, autism was determined to be an other important medical event (OMIC). The reporter indicated that her other 8 year old son had autism after receiving all of the required immunizations (WAES0305USA02785). Additional info has been requested.
Sex: U
Vaccine: MMR
Symptoms: Abnormal behaviour, Autism, Drug withdrawal syndrome
Clinical narrative: Information has been received from a consumer concerning a child who was vaccinated with a dose of MMR II. The consumer reported that the pt developed the symptoms of autism shortly after vaccination, including "flapping his hands and going into his own world." Unspecified medical attention was sought. Upon internal review, symptoms of autism was determined to be an other important medical event (OMIC). The consumer also reported that her nephew developed a similar reaction following vaccination with MMR II (WAES0305USA02300). Further info is not available.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Menorrhagia, Unintended pregnancy
Clinical narrative: Information has been received from a registered nurse, through the pregnancy registry, concerning a 32 year old female with a medical history of a miscarriage in September, 2001 who on 5/3/02 and 6/7/02 was vaccinated with a first and second dose of varicella virus vaccine live, respectively. Subsequently, approximately three weeks following the second dose, she became pregnant. She called the physician's office on 7/23/02 and reported that she was 3 weeks pregnant, "her LMP was6/17/02 and was heavier than usual and she had several positive home pregnancy tests." The pt was advised to come to the office that day for a blood pregnancy test. "On 7/24/02 the pt was called to report the pregnancy test result from the 24th was positive." The EDC was determined to be 3/5/03. It was noted that the pt had exhibited no signs or symptoms. "The pt delivered on 2/20/03, a month early, a male with a birth weight 6lb 7oz." "The pt reported the baby was in the ICU for 1 week after birth because "lungs needed help." On 5/23/03, it was noted that the pt reported the baby was doing fine and was healthy and the pt was also "good." Additional info has been requested.
Age: 1.4
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Autism, Drug withdrawal syndrome
Clinical narrative: Information has been received from a consumer concerning her currently 5 year old nephew with no medical history who was vaccinated with a dose of MMR II when he was 17-18 months old. There were no concomitant medications reported. "Shortly afterwards," he developed the symptoms of autism. He started "flapping his hands and going into his own world." Unspecified medical attention was sought. It was reported that there were no diagnostics studies performed. The outcome was reported as not recovered. Upon internal review, it has been determined that autism is an other important medical event (OMIC). The reporter also reports that "a friend's child had the same experience with the vaccine." (WAES0305USA02474). No further info is available.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Oedema, Pain, Vasodilation procedure
Clinical narrative: 4 year old male developed significant cellulitis of L arm from deltoid to mid f/a requiring 24 hour admission for IV abx followed by Ed course of po Keflex.  Received from discharge summary and medical records swelling, redness and pain entered 12/30/03. msv
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Headache
Clinical narrative: Debilitating headache about 10 hours post-inoculation, lasted about 8 hours. Treated effectively with 400 mg ibuprofen.  Migraine?
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Injection site mass, Myalgia
Clinical narrative: Headaches about 4 days, sore muscles about 4 days. Took Excedrin 1 time daily (PM use). Lump the size of a quarter at vaccination site. Down to size of a dime by next vaccination (5/20).
Age: 30.0
Sex: M
Vaccine: UNK
Symptoms: Headache, Myalgia
Clinical narrative: Headaches 3-4 days continuous, sore muscles (upper back). Took Excedrin 1 x daily for headaches, usually in the afternoon.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site mass, Injection site oedema
Clinical narrative: Excessive swelling (large bump on back of my arm around injection area). Small knot still persists. Swelling lasted 4-5 days.
Age: 2.08
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Erythema, Feeling hot, Oedema, Pruritus
Clinical narrative: Pt's right thigh is quite swollen (almost double the size of her left thigh). It is very red and hot to the touch. Mom states that the pt has been itching and scratching at the site since vaccine was given. Tylenol and Tempra given - cool compresses. Dx cellulitis and given antibiotics.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site oedema
Clinical narrative: Local inflammation dermis, nontender, no pallor, no loss of motion, no inguinal LA.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PPV
Symptoms: Dyspnoea
Clinical narrative: Pt seen at 1:00 PM on 5/6/03, received DTaP #1, Hib #1, IPV #1, Hep B #2, Prevnar #1. Per mom, pt began having breathing difficulty. At 7:00 PM, taken to ER, began to improve about 2:00 PM.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Face oedema
Clinical narrative: Facial swelling noted approx 4-5 minutes after shots. Father ran out of clinic with child before any treatment started. Call ER nurse - says child is fine.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Redness and induration noted to left deltoid area. Given meds: Keflex 250 mg/5ml tsp PO TID, Motrin 100 mg/5ml 2 tsp PO every 8 hours PRN.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash
Clinical narrative: Rash upper body, front and back, also face. Itching - bad.
Age: 22.0
Sex: F
Vaccine: HEP, HEPA, IPV, TD, TYP
Symptoms: Pain
Clinical narrative: Telephone Health Dept 5/6/03. Reports some minor discomfort in right and left arms 1-2 days after injections, but that she has had a "deep ache" in her left arm, unable to lay on left and hurts to move, especially to lift. Advised pt to contact private MD. Pt called Health Dept 5/12 informing that she had made an appointment, but had canceled as her arm was almost back to normal.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Oedema, Pyrexia
Clinical narrative: Fever, swollen, red leg.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Rash
Clinical narrative: Localized rash about a week after vaccine.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Vaccine given 5/6/03 at 9:00 AM, woke up 5/7/03 and left arm red, swollen, and warm in area shot was given. Applying ice, and giving Tylenol.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Mom states child developed chest rash at noontime on 5/16/03. On 5/20 Saturday morning, the child had generalized body rash - pinpoint only. No raised areas. Had mild fever on Friday, but no fever or other complaints on Saturday. No itch or fussiness.
Age: 44.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Arthralgia
Clinical narrative: Received #1 MMR and #1 varicella 2/5/03 and #2 MMR and #2 varicella 4/7/03. On 4/8 noted early AM onset of joint pain (generalized) requiring 400 Motrin TID. Pain resolved in 2 days and nor further problems.
Age: 3.5
Sex: F
Vaccine: HEPA, PNC
Symptoms: Rash
Clinical narrative: Rash mild lower on SAT. Given Diphenhydramine 50 mg, Epinephrine 0.3cc.
Age: 14.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Malaise, Pyrexia
Clinical narrative: Fever 103.1. General malaise. Pain at injection site.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Red and swollen leg around injection site area 9 x 10 cm.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Injection site erythema, Injection site oedema
Clinical narrative: Redness in injection site and swelling - cellulitis.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Client (per mother) developed hives under arm (same arm where vaccine given) and some hives on back.  Mother states this began to occur late on 05/24/2003.  As of 05/29/2003 hives are still present but less itchy.
Sex: U
Vaccine: DTAP, HIBV, PNC
Symptoms: Irritability, Lethargy, Muscular weakness, Neurodevelopmental disorder
Clinical narrative: After DTAP, HIB, Pev 7 #3 on 12/27/2002; patient report that the baby was irritable and "lethargic"-lost interest in playing-withdrawn regressed developmentally for about a month.  She has pale and dark curves around her eyes, lost muscle mass right away.  Diapers child felt "scratchy" ears, pulling out hair.  F/R fontanelle blury for six days.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Redness, swelling, warmth distal to vaccine administration site, Right deltoid.  symptomatic treatment, antibiotic for unrelated problem.
Age: 1.6
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Grand mal convulsion, Irritability, Lethargy, Pyrexia, Rash vesicular
Clinical narrative: 17 days after receiving varicella vaccine-child became febrile, developed mild vesicular rash, and had grand mal seizure.  Had rash compatible with varicella.  The history of recent exposure to varicella-child remained leboite for 5 days.  Rash abated after 1 week.  Child was lethargic and irritable day long.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Red, indurated region on left lower extremity 9 x 14 cm after tetanus shot.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Large area of erythema on the arm where DTAP administered.  Mildly painful.  Treated with Ibuprofen.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site mass
Clinical narrative: Reported by phone call area left arm 2-3 inches long several like tennis ball knot.  Offered appointment mother declined.
Age: 5.4
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site warmth, Skin discolouration
Clinical narrative: 5.5 x 4 cm warm erythematous tense swelling at site of injection.  Mom noted swelling the day following vaccination.  Injection given on right upper outer thigh 1 cm darker area of erythema centrally.  No crusting or drainage.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Rash pruritic
Clinical narrative: Client brought in by stepmother-states child complained of itching in left arm at injection site.  Left deltoid noted to be very red, swollen and warm to touch.  Redness measured 93mm verical & 90mm horizontal.  Child denies pain.  Stepmother called doctor and nurse advised ice packs to area and Tylenol every 4 hours or motrin every 6 hours.  05/27/2003:  Talked with stepmother today.  She states arm looks better.  It is still red but is half the size.  Not hot.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Left deltoid area reddened and swollen approximately 4cm.
Age: 1.3
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Agitation, Pyrexia, Skin ulcer
Clinical narrative: 05/05/2003: 5 large lesions noted-2 on temple, 1 arm, 1 nick, 1 foot. 05/06/2003: 10 more lesions on back, chest, arms, buttocks and genitals. 05/07/2003: 15 more-original lesions and open and draining.  Temperature 100 degrees, and child fussy. 05/09/2003: 2 new pox, old lesions open and draining.  Chicken pox disease in community, but no known exposures.
Age: 5.0
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Blister, Viral infection
Clinical narrative: Started 04/15/2003:  Mild case of chicken pox (10 lesions) after receiving varicella on 04/30/1999.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Dry throat, Pyrexia, Vomiting, Wheezing
Clinical narrative: 05/24/2003: Saturday 4:00am, woke up with temperature of 101 degrees F.  05/25/2003: Sunday, scratchy throat, some wheezing, and vomited x1.  Continued with temperature through Monday 05/26/2003.  Mom states he is feeling better 05/27/2003.
Age: 8.0
Sex: M
Vaccine: PNC
Symptoms: Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: Approximately 12-24 hours after injection (6cm right tricep) swelling at site extending to right elbow, induration and warmness.  Treatment:  NSAIPS/ JLE/ SWETARON.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Injection site vesicles
Clinical narrative: Low grade temperature 100 degrees F, red local site left thigh with blisters.  Seen by MD 05/27/2003.  Assessment: possible attenated virus infection.  Keep covered from other children.  Call if any distal lesions or symptomatic.