chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.39
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Movement disorder, Vaccine positive rechallenge
Clinical narrative: Child started having minor tensing of the legs and arms in the begging of October whitch we thought were just baby quirks, it is now believed to have been minor seizures. They continued to get worse until in mid November she was constantly crying and tensing every few hours. She received another set of shots on 12/01/04. On 12/3/04 I was at my doctor's office when she had a spell, my doctor seen it and said it was seizures, by this time they were so bad that she was either asleep or having a seizure. My doctor sent us over to her doctor who put her on Femabarbitol.By 12/20/04 they were still present and we were sent to a hospital. A follow up appointment was made for 1/3/05 at this visit she was put on Lamictal wih some seizures still present. On 1/06/05 she was hospitalized to start Dilantin because of out of control seizure frequency. On 1/14/05 she was started on Ativan because frequency of seizures was still high. She is currently on Lamictal and Dilantin. Her 2 month well check on 2/28/04 shows we had rolls over one way,communicates by cooing, grasps small objects, watches objects moved across in front of face, and brings hands together. She no longer have rolls over and she is just now trying to do the other things again. Her 4 month well check on 12/1/04 shows she holds head steady when upright,laughs out loud,no head lag, raises chest while on stomach using arms for support,lifts head to 90 degree angle while on stomach, bears weight on legs when held in standing position,follows ob jects moved side to side, along with her acheivements showed on her 2 month well check. She is currently in Physical and occupational therapy to try to restablish these things she no longer does. She has very bad head lag and doesn't crawl and holds her hands in fists along with the lists of things above from her 2 well checks that she no longer does. I have medical records to support these details. Medical records received on 3/11/2005 states infection. Delayed development, on seizure meds.
Age: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: Asthma, Cough, Dyspnoea, Hypoxia, Lobar pneumonia
Clinical narrative: This is a serious spontaneous case from a physician in the USA involving asthma. The reporter causality is not related to FluMist. This case is submitted according to the VAERS accelerated reporting agreement for FluMist. This is a spontaneous case report sent by a physician that refers to a female aged 10 years. The patient's past medical history included pneumonia in October 2003 and in the year 2002. She received FluMist on 12/10/03, the lot number and vaccine administrator were not recorded. On 1/19/04, the patient experienced fever, persistent cough, and shortness of breath. She was brought to the emergency department where she was reported to have decreased oxygen saturation. She was admitted to the hospital with a diagnosis of right lower lobe pneumonia confirmed by chest x-ray and asthma. Structural abnormality/reactive airway disease, and cystic fibrosis were ruled out. Triple IV antibiotics were administered and was placed on oxygen supplement via face mask for several days. During this hospitalization, the patient had episodes of oxygen saturation below 90% while sleeping. The patient has not been diagnosed with asthma before this event. The reporter felt neither pneumonia or asthma were related to FluMist, although he did consider the possibility. The patient has recovered but continues on a daily steroid inhaler and salbutamol as needed.
Age: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia
Clinical narrative: This is a serious spontaneous case from a physician in the USA involving asthma. The reporter causality is not related to FluMist. This case is submitted according to the VAERS accelerated reporting agreement for FluMist. This is a spontaneous case report sent by a physician that refers to a female aged 10 years. The patient's past medical history included pneumonia in October 2003 and in the year 2002. She received FluMist on 12/10/03, the lot number and vaccine administrator were not recorded. On 1/19/04, the patient experienced fever, persistent cough, and shortness of breath. She was brought to the emergency department where she was reported to have decreased oxygen saturation. She was admitted to the hospital with a diagnosis of right lower lobe pneumonia confirmed by chest x-ray and asthma. Structural abnormality/reactive airway disease, and cystic fibrosis were ruled out. Triple IV antibiotics were administered and was placed on oxygen supplement via face mask for several days. During this hospitalization, the patient had episodes of oxygen saturation below 90% while sleeping. The patient has not been diagnosed with asthma before this event. The reporter felt neither pneumonia or asthma were related to FluMist, although he did consider the possibility. The patient has recovered but continues on a daily steroid inhaler and salbutamol as needed.
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Autism
Clinical narrative: Information has been received from a health professional concerning a male who was vaccinated with a dose of MMR. Other vaccinations were routine childhood vaccinations including varicella virus vaccine live and maybe hepatitis B virus vaccine. Subsequently, the patient exhibited signs of autism. Unspecified medical attention was sought. There was no product quality complaint involved. Upon internal review, the patient's autism was considered to be an other important medical event (OMIC). Additional information is not expected.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Injection site swelling, Pain, Sleep disorder
Clinical narrative: Initial and follow up information has been received from a health professional concerning a 70 year old retired white male patient who no reported previous vaccination history and a history of diabetes and weight loss, who on 11/29/04 at 10:49 AM was vaccinated IM in the left deltoid with a first 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot # 649913/0577P). No concomitant medications were reported. On 11/30/04 the patient returned to the office with a severe adverse reaction to the pneumococcal 23v polysaccharide vaccine. It was reported that his left arm was very swollen, very red and he had a bad headache. It was also reported that he was only able to sleep 1-2 hours at a time the same night as the vaccination because of the pain. The doctor recommended the patient take famotidine 2 BID, fexofenadine hydrochloride 180mg every day, and acetaminophen (+) hydrocodone bitartrate 5, 1 every 4 hours or 2 every 6 hours, as needed for pain. It was also reported that the patient had no illness at the time of vaccination and that the patient lost weight and is no longer diabetic. The patient recovered approximately 3 weeks later on an unspecified date. The physician considered the patient's experience to be an other important medical event (OMIC). No product quality complaint was involved. Additional information is not expected.
Age: 32.0
Sex: F
Vaccine: RUB
Symptoms: Decreased appetite, Diarrhoea, Dizziness, Dysphonia, Headache
Clinical narrative: Symptoms started 30 minutes after injection. Vomited at this time. No further vomiting but extremely nauseous til 2/23. Dizzy off and on. Voice became scratchy and hoarse. Neck glands swollen for one day. Slight headache(lasted less than one day). 2/19 hearing R ear seemed to be echoing for about two minutes. Ok after that. Decreased appetite. Loose stools started day vaccine and continued til 2/24/05.
Age: 32.0
Sex: F
Vaccine: RUB
Symptoms: Lymphadenopathy, Nausea, Vomiting
Clinical narrative: Symptoms started 30 minutes after injection. Vomited at this time. No further vomiting but extremely nauseous til 2/23. Dizzy off and on. Voice became scratchy and hoarse. Neck glands swollen for one day. Slight headache(lasted less than one day). 2/19 hearing R ear seemed to be echoing for about two minutes. Ok after that. Decreased appetite. Loose stools started day vaccine and continued til 2/24/05.
Age: 49.0
Sex: M
Vaccine: TYP
Symptoms: Diarrhoea
Clinical narrative: Patient began taking oral typhoid pills every other day.  He took the capsule at 7:00 AM every other morning.  By 1:00 PM on the day he took the vaccine, he began to have bouts of diarrhea.  The diarrhea was significant enough that he self-treated himself with Immodium AD.  He did complete the series of 4 capsules.  He did not have diarrhea on the days he did not take the oral typhoid vaccine.  Patient had previously used the oral typhoid vaccine in 1998.  He does not recall any side effects at that time.
Age: 4.0
Sex: M
Vaccine: DTAP, HEP, MMR, VARCEL
Symptoms: Cough, Drug ineffective, Ocular hyperaemia, Pyrexia, Rash erythematous
Clinical narrative: Mother called on 2/23/05 to report that physician states child has rubella from his vaccine and she should report it to the health department, therefore this report is being filed at the mother's request.   Mother states child received vaccines on 2/10/05.  On 2/12/05 child developed chicken pox.  Other children at the child's daycare center had chicken pox also.  Varicella resolved on 2/19 and on 2/20 child developed fever of 103 degrees with a red, raised, itchy rash over his entire body.  Also has cough, runny nose and bloodshot eyes.  Fever and rash are still present on 2/23/05.  Has appointment with family physician on 2/24/05.   Mother called on 2/24/05 and reported that physician feels he had an allergic reaction to the MMR and should never get that vaccine again. Mother treated child with Benadryl and acetaminophen.  Fever resolved and rash is fading.    It is mother's belief that older brother developed autism after his first MMR.
Age: 4.0
Sex: M
Vaccine: DTAP, HEP, MMR, VARCEL
Symptoms: Rhinorrhoea, Viral infection
Clinical narrative: Mother called on 2/23/05 to report that physician states child has rubella from his vaccine and she should report it to the health department, therefore this report is being filed at the mother's request.   Mother states child received vaccines on 2/10/05.  On 2/12/05 child developed chicken pox.  Other children at the child's daycare center had chicken pox also.  Varicella resolved on 2/19 and on 2/20 child developed fever of 103 degrees with a red, raised, itchy rash over his entire body.  Also has cough, runny nose and bloodshot eyes.  Fever and rash are still present on 2/23/05.  Has appointment with family physician on 2/24/05.   Mother called on 2/24/05 and reported that physician feels he had an allergic reaction to the MMR and should never get that vaccine again. Mother treated child with Benadryl and acetaminophen.  Fever resolved and rash is fading.    It is mother's belief that older brother developed autism after his first MMR.
Age: 25.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site rash, Pruritus
Clinical narrative: 2/18/05 patient rec'd Twinrix A/B Lt.Deltoid.  Patient states within 24 hrs post vaccination noted "small cluster rash" near injection site.  now 2/25/05, (8) days post vaccination rash is on neck, chest, stomach and arms.  Client has self treated, rash is itchy and somewhat relieved with Benadryl orally. No medical evaluation to date.  Noted patient states started taking for the first time, antidepressant "Lexapro" around the same time as rec'd hep A/B vaccination.  Patient is followed by doctor for depression.  Inst. patient to contact doctor to inform of rash.  Will follow up on 2/28/05 with patient.
Age: 0.54
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Loss of consciousness, Pyrexia
Clinical narrative: Pt received shots at about 11:45am on Friday. By Friday evening at 9pm the child spiked a high fever and lost consciousness for 7-8 minutes. 911 was called and the pt was transported to hospital, where he was admitted and spent one day in the hospital for further observation and fever reduction.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Oedema peripheral
Clinical narrative: Fluzone administered on 18 February child stated it hurt right after it was given.  Came into clinic on 20 February.  Arm was markedly edematous and swollen from shoulder to elbow.  Free range of motion of shoulder, elbow, and wrist.  The area was NOT WARM.
Age: 0.49
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Erythema, Pyrexia, Rash
Clinical narrative: Fever (39.1C), bright red rash in groin, up sides and involving axilla and neck crease (anterior and posterior).
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Mother states L arm swollen/red/hot to touch and itches. Area swollen to the size of a softball. She also states there is a white area where the injection site is. Instructed to notify MD.
Age: 1.62
Sex: M
Vaccine: HIBV, VARCEL
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: SWOLLEN ,WARM AND RED. TREATMENT: KELFLEX ANTIBIOTIC
Age: 0.34
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Cold sweat, Dehydration, Lethargy, Pyrexia, Vomiting
Clinical narrative: About an hour after DTaP, IPV, and Prevnar, she started throwing up, had a fever, and then got cold and clammy. She has been dry heaving the rest of the day. She was seen in doctor's office again this evening and she is lethargic, clammy and cold. She is very dehydrated. Doctor admitted her to the hospital for further evaluation.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Laboratory test abnormal, Multiple sclerosis, Nuclear magnetic resonance imaging brain abnormal, Paraesthesia
Clinical narrative: Parathesis, brain lesions, possible multiple sclerosis. Symtoms still ongoing. Treatment catscan, MRI, and spinal tap. Information from medical records states decreased strength. msv
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema
Clinical narrative: Edema
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Angioneurotic oedema, Injection site induration, Injection site pain
Clinical narrative: Angioedema to mid forearm with local pain and induration, that began 24 hours after vaccine administered on 02/02/05.
Age: 50.0
Sex: M
Vaccine: TTOX, TD
Symptoms: Pain
Clinical narrative: Pain in both arms from elbow to just below shoulder, thinks it began in November. Mentioned it to PCP. No treatment at this point. Then went to ER for arm pain where they ran tests for muscle weakness & blood tests. Referred to Cardiologist who tested his heart and found no problems. Referred to rheumatologist, has not had appointment yet. Arm still sore, burning ache and pain varies in intensity.
Age: 50.0
Sex: M
Vaccine: TTOX, TD
Symptoms: Injection site pain, Muscle spasms, Skin burning sensation
Clinical narrative: Pain in both arms from elbow to just below shoulder, thinks it began in November. Mentioned it to PCP. No treatment at this point. Then went to ER for arm pain where they ran tests for muscle weakness & blood tests. Referred to Cardiologist who tested his heart and found no problems. Referred to rheumatologist, has not had appointment yet. Arm still sore, burning ache and pain varies in intensity.
Age: 24.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Headache, Somnolence
Clinical narrative: Severe Headache with dizziness. Somnolence, reports sleeping from 5PM to 6 AM next day.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Kawasaki's disease
Clinical narrative: Developed kawasaki disease on 03/15/04
Age: 4.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Oedema peripheral, Pyrexia, Vomiting
Clinical narrative: Patient was given Pneum. 23 vaccine on 02/11/05. On 02/1305, a call was placed to fellow on call, reporting a swollen arm (tennis ball size), vomiting and low grade fever. Patient was sent to ER where he was given Keflex and discharged.
Age: 4.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Cellulitis, Feeling hot, Pain, Pyrexia, Swelling
Clinical narrative: Patient was given Pneum. 23 vaccine on 02/11/05. On 02/1305, a call was placed to fellow on call, reporting a swollen arm (tennis ball size), vomiting and low grade fever. Patient was sent to ER where he was given Keflex and discharged.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema
Clinical narrative: Vaccine administered on 02/16/05, MMR to right arm, 5x4 cm erythemic area.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Feeling hot, Nausea, Syncope
Clinical narrative: During injection employee became warm. She stated she felt faint and nauseated. She was given a few minutes to recover and did so quickly. Donor recovered completely.
Age: 5.0
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Erythema
Clinical narrative: Hugh erythema, swelling 13 x 17cm  on left mid-proximal thigh. Child can walk.
Age: 0.18
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Rash maculo-papular
Clinical narrative: Immunization was performed on 12/28/04 to a 2 month old baby boy. On 12/29/04, the boy began to develop a skin rash of erythematous macular papular lesions, of round shape and varied in size from 1cm to 3cm. The lesions were all over body except for th face and scalp, mostly on extremities.
Age: 1.02
Sex: F
Vaccine: DTAP, HBHEPB, MMR, PNC, VARCEL
Symptoms: Rash papular, Upper respiratory tract infection
Clinical narrative: Mother of baby states pimple like rash started on her back, side and up the neck 3 days after receiving vaccines. She states baby was taken to doctor on that same day and was told it was probably from the chickenpox vaccine. No fever but has symptoms of upper respiratory infection.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Patient has 22-25 discrete vesicular, small itchy lesions developed over scalp, face, torso and legs. Most spots are dried now, they began on 02/11/05 until today 02/16/05.
Age: 1.55
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Varicelliform rash after receiving vaccine on 01/28/05.
Age: 1.43
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Infection
Clinical narrative: Developed chicken pox.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Eye swelling, Face oedema, Fatigue, Feeling hot
Clinical narrative: Two days after receiving second Hep B vaccine, patient reports she developed swelling to face, eyes became puffy, face red and hot, lymph nodes to neck tender and enlarged, felt groggy and tired. Patient called on 02/21/05, five days after vaccine and symptoms had improved. Patient treated self with Benadryl.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Lymph node pain, Lymphadenopathy, Somnolence
Clinical narrative: Two days after receiving second Hep B vaccine, patient reports she developed swelling to face, eyes became puffy, face red and hot, lymph nodes to neck tender and enlarged, felt groggy and tired. Patient called on 02/21/05, five days after vaccine and symptoms had improved. Patient treated self with Benadryl.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: Patient has a temperature of 103-104 degrees, eight days after vaccine administration. Fever began in the middle of the night and lasted 12 hours. No other symptoms. No other ill effects.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Oedema peripheral
Clinical narrative: Swelling to upper left arm, non tender.
Sex: U
Vaccine: UNK
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Developed firm lumps at all injection sites, then redness/eyrthema developed on left thigh. "Favoring" leg and irritable. Examination on 02/18/05, induration/lump approximately 2.5 cm with approximately 1cm of overlaying erythema and some tenderness. Treated with Keflex.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Anti-HBS Anitbody Negative- No Narrative Available.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Antibody-HBS antibody negative No narrative available.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, CSF test abnormal, Multiple sclerosis, Muscular weakness, Neuropathy
Clinical narrative: Symptoms are facial nerve involvement, weakness and severe weakness in extermities. Information from Medical records states multiple sclerosis. msv
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Diarrhoea, Fatigue, Malaise, Myalgia
Clinical narrative: Extreme joint and muscle pain and unable to flex joints starting 15 days after innoculation.  Different joints affected on subsequent days.  General feeling of malaise and tiredness.  Soft bowel movements.
Age: 17.0
Sex: M
Vaccine: BCG, CHOL, DTPIHI, FLUX, MMR, OPV, PLAGUE, PPV
Symptoms: Angiopathy, Bronchitis, Chills, Dyspnoea, Gastrointestinal disorder
Clinical narrative: Repeated pneumonia, multiple bronchitis, and mono-nucleosis, gastro-intestinal distress, fevers, chills, hospitalization. Life long: yearly pneumonias resistant to inoculation, annual and bi-annual bronchitis, symptoms of COPD and chronic breathing problems not associated with asthma.  Chronic fatique.  Cardio-Vascular degeneration, high blood pressure, and events and tendancy toward vascular dissection.
Age: 17.0
Sex: M
Vaccine: BCG, CHOL, DTPIHI, FLUX, MMR, OPV, PLAGUE, PPV
Symptoms: Hypertension, Lung disorder, Pneumonia, Pyrexia, Viral infection
Clinical narrative: Repeated pneumonia, multiple bronchitis, and mono-nucleosis, gastro-intestinal distress, fevers, chills, hospitalization. Life long: yearly pneumonias resistant to inoculation, annual and bi-annual bronchitis, symptoms of COPD and chronic breathing problems not associated with asthma.  Chronic fatique.  Cardio-Vascular degeneration, high blood pressure, and events and tendancy toward vascular dissection.
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Rash maculo-papular
Clinical narrative: Generalized maculopapular rash 12 hrs after vaccine.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Coordination abnormal, Erythema, Hypersensitivity, Tremor
Clinical narrative: Patient received Hep A vaccine on 02/16/05. Developed symptoms of leg trembling and redness on leg on 02/21/05. Examined 02/25/05, noted ataxia and possible hypersensitivty.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Convulsion
Clinical narrative: This case was reported by a physician and described the occurrence of a seizure in a 4 month old male patient who received diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant, and inactivated poliovirus vaccine combined. The patient's medical history is notable for newborn jaundice which resolved without phototherapy, hospitalization in September 2004 for a febrile illness and rotavirus infection, reactive airway disease, and bottle feeding. Family history is notable for an uncle with mental retardation syndrome. Concurrent medications included Singulair to treat the reactive airway disease. At the time of the immunizations, the patient had a concurrent upper respiratory infection with respiratory congestion and coughing. On 12/14/04, at approximately 12:30 PM, the patient received the second dose of Pediarix (lot # AC21A008AA). On the same date, at approximately 12:30 PM, the patient also received injections of Haemophilus influenzae type B conjugate vaccine, and 7 valent pneumococcal conjugate vaccine. Following the administration of the vaccines, on 12/14/04, the patient was taken to a babysitter. The babysitter's child had a cold on 12/14/04. Approximately two hours following the administration of the injections, on 12/14/04, the patient became purple and was not breathing. The babysitter and the father took the patient to an emergency room. On the way to the emergency room, the patient received two to three breaths from the babysitter and started breathing. In the emergency room, the patient experienced a seizure manifested as rolling eyes and body stiffening. The patient was treated with phenobarb and Ativan and the seizure resolved. The physician stated that the parents and babysitter, had not noted any fever just by touching him throughout this time. Laboratory investigations were notable for a normal chest x-ray, ok electrolytes, and a white blood cell count of 17,000. The patient was hospitalized. The events resolved on 12/14/04. The physician considered the events to be life threatening and to require clinical intervention. The physician considered the events to be possibly related to immunization with Pediarix. This report was initially received from another manufacturer.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Apnoea, Convulsion, Cyanosis, Eye movement disorder, Musculoskeletal stiffness
Clinical narrative: This case was reported by a physician and described the occurrence of a seizure in a 4 month old male patient who received diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant, and inactivated poliovirus vaccine combined. The patient's medical history is notable for newborn jaundice which resolved without phototherapy, hospitalization in September 2004 for a febrile illness and rotavirus infection, reactive airway disease, and bottle feeding. Family history is notable for an uncle with mental retardation syndrome. Concurrent medications included Singulair to treat the reactive airway disease. At the time of the immunizations, the patient had a concurrent upper respiratory infection with respiratory congestion and coughing. On 12/14/04, at approximately 12:30 PM, the patient received the second dose of Pediarix (lot # AC21A008AA). On the same date, at approximately 12:30 PM, the patient also received injections of Haemophilus influenzae type B conjugate vaccine, and 7 valent pneumococcal conjugate vaccine. Following the administration of the vaccines, on 12/14/04, the patient was taken to a babysitter. The babysitter's child had a cold on 12/14/04. Approximately two hours following the administration of the injections, on 12/14/04, the patient became purple and was not breathing. The babysitter and the father took the patient to an emergency room. On the way to the emergency room, the patient received two to three breaths from the babysitter and started breathing. In the emergency room, the patient experienced a seizure manifested as rolling eyes and body stiffening. The patient was treated with phenobarb and Ativan and the seizure resolved. The physician stated that the parents and babysitter, had not noted any fever just by touching him throughout this time. Laboratory investigations were notable for a normal chest x-ray, ok electrolytes, and a white blood cell count of 17,000. The patient was hospitalized. The events resolved on 12/14/04. The physician considered the events to be life threatening and to require clinical intervention. The physician considered the events to be possibly related to immunization with Pediarix. This report was initially received from another manufacturer.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: White blood cell count increased
Clinical narrative: This case was reported by a physician and described the occurrence of a seizure in a 4 month old male patient who received diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant, and inactivated poliovirus vaccine combined. The patient's medical history is notable for newborn jaundice which resolved without phototherapy, hospitalization in September 2004 for a febrile illness and rotavirus infection, reactive airway disease, and bottle feeding. Family history is notable for an uncle with mental retardation syndrome. Concurrent medications included Singulair to treat the reactive airway disease. At the time of the immunizations, the patient had a concurrent upper respiratory infection with respiratory congestion and coughing. On 12/14/04, at approximately 12:30 PM, the patient received the second dose of Pediarix (lot # AC21A008AA). On the same date, at approximately 12:30 PM, the patient also received injections of Haemophilus influenzae type B conjugate vaccine, and 7 valent pneumococcal conjugate vaccine. Following the administration of the vaccines, on 12/14/04, the patient was taken to a babysitter. The babysitter's child had a cold on 12/14/04. Approximately two hours following the administration of the injections, on 12/14/04, the patient became purple and was not breathing. The babysitter and the father took the patient to an emergency room. On the way to the emergency room, the patient received two to three breaths from the babysitter and started breathing. In the emergency room, the patient experienced a seizure manifested as rolling eyes and body stiffening. The patient was treated with phenobarb and Ativan and the seizure resolved. The physician stated that the parents and babysitter, had not noted any fever just by touching him throughout this time. Laboratory investigations were notable for a normal chest x-ray, ok electrolytes, and a white blood cell count of 17,000. The patient was hospitalized. The events resolved on 12/14/04. The physician considered the events to be life threatening and to require clinical intervention. The physician considered the events to be possibly related to immunization with Pediarix. This report was initially received from another manufacturer.
Age: 17.0
Sex: F
Vaccine: TD, TD
Symptoms: Headache, Injection site pain, Nausea
Clinical narrative: Stated her arm hurt after getting a tetanus shot slight redness and induration at site pin sized c/o pain arm vs taken warm pk and see PMD if no relief.
Age: 17.0
Sex: F
Vaccine: TD, TD
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Stated her arm hurt after getting a tetanus shot slight redness and induration at site pin sized c/o pain arm vs taken warm pk and see PMD if no relief.
Age: 1.9
Sex: U
Vaccine: PNC
Symptoms: Pleural effusion, Pneumonia, Sepsis
Clinical narrative: This case was considered medically important. Information regarding Prevnar (pneumococcal 7valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a published literature article, regarding a 23 month old pt in an independent study, who experienced pneumonia with effusion. At 7 months of age, the pt received the third dose on an unspecified date. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose. Concomitant medications were not reported. A literature article, citing an independent study that reviewed cases of invasive pneumococcal disease, reported that a pt received the third dose of Prevnar at 7 months of age. At 23 months of age, the pt developed pneumonia with effusion.  A culture performed on an unspecified date revealed Streptococcus pneumonaie, serotype 19A. The author concluded from all study cases assessed that universal administration of Prevnar to children younger than 2 years of age and selective administration to children 2 to 5 years of age has resulted in a significant decline in invasive pneumococcal disease. Children younger than one year of age, African American and Hispanic children and those with recognized co morbid illnesses (malignancy, human immunodeficiency virus, immune deficiency, nephrotic syndrome, etc.) continue to remain at risk for invasive pneumococcal disease. The investigator considered pneumonia pneumococcal and drug ineffective (expected as per the prescribing information) and pleural effusion (unexpected as per the prescribing information) to be possibly related to the study product. See attached literature article for additional information.
Age: 1.92
Sex: U
Vaccine: PNC
Symptoms: Bacterial infection, Cellulitis, Sepsis
Clinical narrative: This case was considered medically important. Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a published literature article for childhood invasive pneumococcal disease in the era of conjugate vaccine. The article reported that a 6 month old participant in an independent study, received a third dose of Prevnar on an unspecified date. At 23 months of age, the participant developed cellulitis and pneumococcal bacteremia. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose. Concomitant medications were not reported. A literature article, citing an independent study that reviewed cases of invasive pneumococcal disease, reported that at 6 months of age a study participant received a third dose of Prevnar. At 23 months of age, the participant developed cellulitis with bacteremia after a blood culture performed on an unspecified date revealed Streptococcus pneumoniae, serotype 19A. The author concluded from all study cases assessed that universal administration of Prevnar to children younger than 2 years of age and selective administration to children 2 to 5 years of age has resulted in a significant decline in invasive pneumococcal disease. Children younger than one year of age, African American and Hispanic children and those with recognized comorbid illnesses (malignancy, human immunodeficiency virus, immune deficiency, nephrotic syndrome, etc.) continue to remain at risk for invasive pneumococcal disease. See attached literature article for additional information. The investigator considered cellulitis streptococcal, pneumococcal bacteraemia and drug ineffective to be possibly related to the study product. Blood culture was done on an unspecified date.
Age: 1.33
Sex: M
Vaccine: DTAPHEPBIP, HEP, HIBV, MMR
Symptoms: Rash
Clinical narrative: Rash began 1 week post immunizations.  Slight redness behind ears.  Continuously worsened.  Currently on back, stomach, face, ears, buttocks, scrotum.  Red, raised whelps.  None on arms, legs, feet, or hands.  No fever, no itching, no fussiness.  Mother to call private MD.
Age: 26.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Collagen-vascular disease, Coordination abnormal, Cyst, Depression, Dermatitis
Clinical narrative: Multiple lipomas, headaches, dizziness, fatigue, nausea, depression, collagen vascular disease (localized scleroderma), dermatitis, multiple sclerosis, chronic fatigue syndrome, chronic pain. Tumefastic multiple sclerosis. A follow up report was submitted on 7/28/05. Currently, the subject is still experiencing symptoms of Multiple Sclerosis and is planning to see a neurologist for follow up health care. Per follow up report-Uncommon form of multiple sclerosis-Tumefastic form. Chronic pain, chronic fatigue, ataxia, full disability. Collegen vascular disease and cysts. FDA and NIH as well as the DOD and VA system are corrupt in pushing the Anthrax vaccine next to civilians and military.
Age: 26.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Dizziness, Fatigue, Headache, Lipoma, Multiple sclerosis
Clinical narrative: Multiple lipomas, headaches, dizziness, fatigue, nausea, depression, collagen vascular disease (localized scleroderma), dermatitis, multiple sclerosis, chronic fatigue syndrome, chronic pain. Tumefastic multiple sclerosis. A follow up report was submitted on 7/28/05. Currently, the subject is still experiencing symptoms of Multiple Sclerosis and is planning to see a neurologist for follow up health care. Per follow up report-Uncommon form of multiple sclerosis-Tumefastic form. Chronic pain, chronic fatigue, ataxia, full disability. Collegen vascular disease and cysts. FDA and NIH as well as the DOD and VA system are corrupt in pushing the Anthrax vaccine next to civilians and military.
Age: 26.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Nausea, Pain, Scleroderma
Clinical narrative: Multiple lipomas, headaches, dizziness, fatigue, nausea, depression, collagen vascular disease (localized scleroderma), dermatitis, multiple sclerosis, chronic fatigue syndrome, chronic pain. Tumefastic multiple sclerosis. A follow up report was submitted on 7/28/05. Currently, the subject is still experiencing symptoms of Multiple Sclerosis and is planning to see a neurologist for follow up health care. Per follow up report-Uncommon form of multiple sclerosis-Tumefastic form. Chronic pain, chronic fatigue, ataxia, full disability. Collegen vascular disease and cysts. FDA and NIH as well as the DOD and VA system are corrupt in pushing the Anthrax vaccine next to civilians and military.
Age: 26.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Angiopathy, Asthenia, Back pain, Carpal tunnel syndrome, Clumsiness
Clinical narrative: Multiple lipomas, headaches, dizziness, fatigue, nausea, depression, collagen vascular disease (localized scleroderma), dermatitis, multiple sclerosis, chronic fatigue syndrome, chronic pain. Tumefastic multiple sclerosis. A follow up report was submitted on 7/28/05. Currently, the subject is still experiencing symptoms of Multiple Sclerosis and is planning to see a neurologist for follow up health care. Per follow up report-Uncommon form of multiple sclerosis-Tumefastic form. Chronic pain, chronic fatigue, ataxia, full disability. Collegen vascular disease and cysts. FDA and NIH as well as the DOD and VA system are corrupt in pushing the Anthrax vaccine next to civilians and military.
Age: 26.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Depression, Dermatitis, Dizziness, Dysarthria, Fatigue
Clinical narrative: Multiple lipomas, headaches, dizziness, fatigue, nausea, depression, collagen vascular disease (localized scleroderma), dermatitis, multiple sclerosis, chronic fatigue syndrome, chronic pain. Tumefastic multiple sclerosis. A follow up report was submitted on 7/28/05. Currently, the subject is still experiencing symptoms of Multiple Sclerosis and is planning to see a neurologist for follow up health care. Per follow up report-Uncommon form of multiple sclerosis-Tumefastic form. Chronic pain, chronic fatigue, ataxia, full disability. Collegen vascular disease and cysts. FDA and NIH as well as the DOD and VA system are corrupt in pushing the Anthrax vaccine next to civilians and military.
Age: 26.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Gait disturbance, Granulocytosis, Headache, Hypoaesthesia, Influenza like illness
Clinical narrative: Multiple lipomas, headaches, dizziness, fatigue, nausea, depression, collagen vascular disease (localized scleroderma), dermatitis, multiple sclerosis, chronic fatigue syndrome, chronic pain. Tumefastic multiple sclerosis. A follow up report was submitted on 7/28/05. Currently, the subject is still experiencing symptoms of Multiple Sclerosis and is planning to see a neurologist for follow up health care. Per follow up report-Uncommon form of multiple sclerosis-Tumefastic form. Chronic pain, chronic fatigue, ataxia, full disability. Collegen vascular disease and cysts. FDA and NIH as well as the DOD and VA system are corrupt in pushing the Anthrax vaccine next to civilians and military.
Age: 26.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Laboratory test abnormal, Lipoma, Lymphopenia, Multiple sclerosis, Nausea
Clinical narrative: Multiple lipomas, headaches, dizziness, fatigue, nausea, depression, collagen vascular disease (localized scleroderma), dermatitis, multiple sclerosis, chronic fatigue syndrome, chronic pain. Tumefastic multiple sclerosis. A follow up report was submitted on 7/28/05. Currently, the subject is still experiencing symptoms of Multiple Sclerosis and is planning to see a neurologist for follow up health care. Per follow up report-Uncommon form of multiple sclerosis-Tumefastic form. Chronic pain, chronic fatigue, ataxia, full disability. Collegen vascular disease and cysts. FDA and NIH as well as the DOD and VA system are corrupt in pushing the Anthrax vaccine next to civilians and military.
Age: 26.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Scleroderma, Sinusitis, Skin ulcer, Tendonitis, White blood cell count increased
Clinical narrative: Multiple lipomas, headaches, dizziness, fatigue, nausea, depression, collagen vascular disease (localized scleroderma), dermatitis, multiple sclerosis, chronic fatigue syndrome, chronic pain. Tumefastic multiple sclerosis. A follow up report was submitted on 7/28/05. Currently, the subject is still experiencing symptoms of Multiple Sclerosis and is planning to see a neurologist for follow up health care. Per follow up report-Uncommon form of multiple sclerosis-Tumefastic form. Chronic pain, chronic fatigue, ataxia, full disability. Collegen vascular disease and cysts. FDA and NIH as well as the DOD and VA system are corrupt in pushing the Anthrax vaccine next to civilians and military.
Age: 26.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Immune system disorder, Lipoma, Multiple sclerosis, Neuropathy peripheral, Scleroderma
Clinical narrative: Multiple lipomas, headaches, dizziness, fatigue, nausea, depression, collagen vascular disease (localized scleroderma), dermatitis, multiple sclerosis, chronic fatigue syndrome, chronic pain. Tumefastic multiple sclerosis. A follow up report was submitted on 7/28/05. Currently, the subject is still experiencing symptoms of Multiple Sclerosis and is planning to see a neurologist for follow up health care. Per follow up report-Uncommon form of multiple sclerosis-Tumefastic form. Chronic pain, chronic fatigue, ataxia, full disability. Collegen vascular disease and cysts. FDA and NIH as well as the DOD and VA system are corrupt in pushing the Anthrax vaccine next to civilians and military.
Age: 1.14
Sex: F
Vaccine: FLU3
Symptoms: Rash macular
Clinical narrative: Macular generalized rash
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Pt. got a post-MMR rash.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Pt. got a post-MMR rash.
Age: 1.24
Sex: F
Vaccine: DTAP, FLU3, HIBV, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Pt. developed a post MMR rash.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever(103), Tugging at right ear, Mild rash on chest.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Pharyngolaryngeal pain, Urticaria
Clinical narrative: Late on the day of the shot patient had redness and warmth at site of injection, the next day patient developed hive like redness on the face and slight discomfort to the throat.
Age: 2.0
Sex: M
Vaccine: HIBV, PNC
Symptoms: Acute leukaemia, Oedema peripheral
Clinical narrative: LEFT ARM SWOLLEN-DELAYED REACTION. Began two days after injection. Received mutiple injections this day.
Age: 18.0
Sex: F
Vaccine: HEP, MMR, TD, VARCEL
Symptoms: Rash pruritic
Clinical narrative: 17 yo s/p varicella vaccine admin #1 on 2/11/05 presented for varicella #2 today with c/o pruritic rash on face and trunk x 2 days.  No fever or constitutional symptoms.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Flushing, Hypokinesia, Muscular weakness, Myalgia, Pain
Clinical narrative: Experienced immediate intense burning after AVA #3 - worse than other AVA immunizations- that began at the injection site on R anterior arm, went up to R shoulder, into neck, toward occiput, than into L shoulder and down to L hand. R hand ok. This lasted 10 min, real flushed feeling. Resolved except tingling both arms and neck. 4 days later still experiencing tingling in all locations on both arms, back, neck, through both shoulders. No fatigue, but unable to run as he usually does these last couple days due to generalized muscle weakness, aching. No fever, no headache, no depression, no GI symptoms. Feels tightness, muscle feels constricted, sore to move, able to lift R arm with light pain. States injected with AVA in the front of his arm, near the axilla. He is able to work but is very uncomfortable.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Paraesthesia, Skin burning sensation
Clinical narrative: Experienced immediate intense burning after AVA #3 - worse than other AVA immunizations- that began at the injection site on R anterior arm, went up to R shoulder, into neck, toward occiput, than into L shoulder and down to L hand. R hand ok. This lasted 10 min, real flushed feeling. Resolved except tingling both arms and neck. 4 days later still experiencing tingling in all locations on both arms, back, neck, through both shoulders. No fatigue, but unable to run as he usually does these last couple days due to generalized muscle weakness, aching. No fever, no headache, no depression, no GI symptoms. Feels tightness, muscle feels constricted, sore to move, able to lift R arm with light pain. States injected with AVA in the front of his arm, near the axilla. He is able to work but is very uncomfortable.
Age: 0.34
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Convulsion, Diarrhoea, Dyskinesia, Hypoxia, Meningitis
Clinical narrative: Patient presented with new onset seizures and fever 2 days after receiving routine 4 month vaccines.  Pt developed diarrhea and low grade temp one day after routine visit.  Pt had sepsis work up on arrival to local hospital .  Pt given Ativan for tonic-clonic movements on route to hospital (on 2/26/05).  Pt given phenobarbital and intubated for repeated seizures.  Pt now with diagnosis of meningitis, pending cultures. Pt being evaluated by neurology for spindle coma and complex febrile seizures.
Age: 0.34
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: Patient presented with new onset seizures and fever 2 days after receiving routine 4 month vaccines.  Pt developed diarrhea and low grade temp one day after routine visit.  Pt had sepsis work up on arrival to local hospital .  Pt given Ativan for tonic-clonic movements on route to hospital (on 2/26/05).  Pt given phenobarbital and intubated for repeated seizures.  Pt now with diagnosis of meningitis, pending cultures. Pt being evaluated by neurology for spindle coma and complex febrile seizures.
Age: 17.0
Sex: F
Vaccine: HEPA, YF
Symptoms: Chest discomfort, Dizziness, Pain, Urticaria
Clinical narrative: After the shot that day had a sore arm where both YF and Hep A were given; extended up into her neck. No fever. Two days after the shot she noticed some hives located between her shoulder blades which have since changed locations in different areas on her trunk or arms. Has been taking Benadryl. Today c/o her chest getting tight, a little dizzy. Her grandmother was taking her to the ER for treatment at the time of the call by her aunt and mother to the HD.
Age: 15.0
Sex: M
Vaccine: TTOX
Symptoms: Haematoma, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Raised, red rash over back and chest, spread to extremities and genitals over the course of several days. And Malaise. Also, a warm, red ring around the vaccination site, with swelling, erythema and induration.  10 days after vaccine administered, patient still has induration the size of a walnut, bluish hematoma, rash subsided.
Age: 15.0
Sex: M
Vaccine: TTOX
Symptoms: Malaise, Rash erythematous
Clinical narrative: Raised, red rash over back and chest, spread to extremities and genitals over the course of several days. And Malaise. Also, a warm, red ring around the vaccination site, with swelling, erythema and induration.  10 days after vaccine administered, patient still has induration the size of a walnut, bluish hematoma, rash subsided.
Age: 0.34
Sex: M
Vaccine: HEP
Symptoms: Decreased appetite, Diarrhoea, Vaccine positive rechallenge, Vomiting
Clinical narrative: My son had 2 adverse reactions to the DTaP vaccination.  This form is regarding the reaction that he had when he was 4 months old.  He had his shot on December 23rd and his appetite immediately decreased.  Two days later, he began with vomiting and diarrhea.  His symptoms lasted for about 3 weeks and he was seen in the Emergency Room on 12/31/04.  They didn't believe me when I said it was a reaction to the shots and labeled it the "flu".  My son then had the EXACT same response to the shot when it was given to him again at 6 months of age.
Age: 43.0
Sex: F
Vaccine: HEPA
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Patient developed a rash on the arm that the injection was given.  The rash is in two spots and was better by the time we viewed it.  I did take pictures of the rash.  It was a raised, red, congruous rash that did itch.  There were no other problems reported.  I would be happy to email the pictures if that would be helpful.  I called the client today and she reported that the rash is "almost gone".
Age: 35.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Pericarditis
Clinical narrative: Chest pain with dx pericarditis, rx with NSAIDS.