chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.6
Sex: M
Vaccine: HIBV
Symptoms: Abnormal behaviour, Cognitive disorder, Drug toxicity, Drug withdrawal syndrome, Neurodevelopmental disorder
Clinical narrative: Information has been received from an attorney regarding a 12 month old male. On 5/26/95, at 7 months of age, he received his third dose of Hib-TITER. He also received four doses of Tripedia, one dose of Tetramune, and three doses of Recombivax vaccines between the time period of 1/25/99 to 12/19/02. It is alleged that as a result of exposure to these vaccines, he experienced thimerosal-induced mercury poisoning. It is alleged that due to the accumulation of mercury in his body, he also experienced developmental delays including but not limited to becoming withdrawn, unable to speak, unresponsive to his environment, engaging in repetitive behavior, loss of language skills, and loss of motor skills. Mercury poisoning is considered medically important.
Age: 0.4
Sex: F
Vaccine: DTAP, HBPV, PNC
Symptoms: Crying, Dyspnoea, Injection site hypersensitivity, Lethargy, Ocular hyperaemia
Clinical narrative: Inconsolable crying, gasping and excessive sweating began 8 hours after immunizations were administered.  Went to the ER and checked pulse ox (99%) and heartrate (140 bpm).  Gasping continued for 2 hours and tapered off.  Face was pale, eyes were red.  Remained in the ER for 2 hours for observation after the end of symptoms.  She had been on Infant's Motrin to help relieve any pain or fever associated with the immunizations.  Woke at 3 am with a fever of 101.2 and lethargic(normal temp is 97.4).  Administered more Motrin to help bring down temperature.  Took temp again in AM it was 99.6  Face was still pale and eyes were still red.  Crying continued and immunization site of DTaP began to swell to the size of a dime (around 11am).  It became raised, hard, and hot.  Called the doctor's office again and was told to take her to clinic.  Fell asleep and let her nap before taking her in since she hadn't slept well since receiving her immunizations.  She woke 2 hours later crying inconsolably again.  Arrived at clinic, doctor spoke with me about how she was doing.  By this time her injection site was the size of a quarter, still raised, hard, and hot.  Doctor told me it was in infection and gave a script for antibiotics.  Crying lasted until the night (approx. 36 hours after immunization).  She slept all night and woke up looking and feeling much better.  Basic Observations: **Normal eating habits were every 2 hours during waking hours, and 3 times at night (between 10 pm and 10 am).  Since administration of immunizations she only nursed 6 times total (longer than a 24 hour period). **Glassy-eyed stare, did not recognize parents or sibling.  Did not laugh, smile or respond normally to stimuli. **When not crying inconsolably appeared very lethargic.
Age: 0.4
Sex: F
Vaccine: DTAP, HBPV, PNC
Symptoms: Pallor, Pyrexia
Clinical narrative: Inconsolable crying, gasping and excessive sweating began 8 hours after immunizations were administered.  Went to the ER and checked pulse ox (99%) and heartrate (140 bpm).  Gasping continued for 2 hours and tapered off.  Face was pale, eyes were red.  Remained in the ER for 2 hours for observation after the end of symptoms.  She had been on Infant's Motrin to help relieve any pain or fever associated with the immunizations.  Woke at 3 am with a fever of 101.2 and lethargic(normal temp is 97.4).  Administered more Motrin to help bring down temperature.  Took temp again in AM it was 99.6  Face was still pale and eyes were still red.  Crying continued and immunization site of DTaP began to swell to the size of a dime (around 11am).  It became raised, hard, and hot.  Called the doctor's office again and was told to take her to clinic.  Fell asleep and let her nap before taking her in since she hadn't slept well since receiving her immunizations.  She woke 2 hours later crying inconsolably again.  Arrived at clinic, doctor spoke with me about how she was doing.  By this time her injection site was the size of a quarter, still raised, hard, and hot.  Doctor told me it was in infection and gave a script for antibiotics.  Crying lasted until the night (approx. 36 hours after immunization).  She slept all night and woke up looking and feeling much better.  Basic Observations: **Normal eating habits were every 2 hours during waking hours, and 3 times at night (between 10 pm and 10 am).  Since administration of immunizations she only nursed 6 times total (longer than a 24 hour period). **Glassy-eyed stare, did not recognize parents or sibling.  Did not laugh, smile or respond normally to stimuli. **When not crying inconsolably appeared very lethargic.
Age: 1.6
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Cellulitis, Injection site abscess
Clinical narrative: cellulitis and abscess at injection site of DTaP requiring surgical I&D and outpatient antibiotics
Age: 0.27
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Crying, Injection site erythema, Oedema peripheral
Clinical narrative: MOC called & reports child crying since getting home (3 pm) from dr's appt. Also with redness, swelling left thigh instructed to come to office. Arrived 3:15 pm,  Motrin 3cc/ice pack to left thigh, Observed  X 1 hr, Babe fell asleep, Minor swelling noted on arrival subsided.
Age: 17.0
Sex: M
Vaccine: TD
Symptoms: Enzyme abnormality, Pain, Rhabdomyolysis
Clinical narrative: Report received at manufacturer on Sept. 16,2002 from a physician. It was reported that a 17 yr old male received a "diphtheria- tetanus booster (lot number U0376AA) in his left deltoid region". 48 hours after vaccination, pt was admitted to the hospital with rhabdomyolysis. Pt experienced pain in both upper extremities but nowhere else and markedly elevated muscle enzymes reflective of his rhabdomyolysis. Pt did not develop renal complications and was discharged. Pt is currently seen by a Pediatric Gastroenterologist for his chronic hepatitis B infection. Follow up on 12/02/03: "From additional info obtained on 11/26/03 through a telephone call to the reporter, he stated that he remembered the medical circumstances of this case, as he was brought in for consultation, but this was never his pt.  Due to missing pt identifying info, the reporter was unable to access any files.  He stated that this pt was hospitalized and that the AE was temporarily related to the vaccine.  No other info was provided at this time." Follow up on 05/17/04 states: "No additional information could be obtained. No further information is anticipated, this case is considered closed."
Age: 14.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Asthenia, Guillain-Barre syndrome, Headache, Vomiting
Clinical narrative: 06/20/2002 sustained sunburn while out commercial fishing with family. 06/22/2002 went to ER with C/O HA, vomiting, weakness especially in lower extremities. MD suspected Guillain Barre. Med-vacted to another hospital. Received 5 days Immuoglobuin responded very well. Neurologist stated to mother that he felt this was due to Hep B immunization received 2 months prior. Other neurologist were not committed. Pt has fully recovered per mom. She still receives intermedient p.t. for hip weakness. The discharge summary states GBS.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Dysphagia, Dyspnoea, Headache, Vomiting, Wheezing
Clinical narrative: Given 2nd in series of Hep B vaccine. Developed frontal H/A 45mins later as she had with 1st dose. 1 hour post injection she started to have difficulty swallowing and then started to wheeze. Difficulty swallowing and wheezing worsened rapidly. She stated she could not breathe. She was spitting up thick white phlegm. EPI 0.2cc given Sp and O2 per/cc. Symptoms rapidly cleared.
Age: 1.08
Sex: F
Vaccine: DTAP, HEP, MMR, VARCEL, DTAP, HEP, MMR, VARCEL
Symptoms: Asthenia, Convulsion, Pyrexia, Thinking abnormal
Clinical narrative: 8/1-1st seizure-brief, interporlonged. Hosp 8/1-3 seizure in hosp. Last time intubated x few hrs. Neg CT scan, EEG. B/O weakness, mental states change. 8/9 home post neg LP, home 8/10.
Age: 1.08
Sex: F
Vaccine: DTAP, HEP, MMR, VARCEL, DTAP, HEP, MMR, VARCEL
Symptoms: Convulsion, Dyskinesia, Pyrexia, Upper respiratory tract infection
Clinical narrative: 8/1-1st seizure-brief, interporlonged. Hosp 8/1-3 seizure in hosp. Last time intubated x few hrs. Neg CT scan, EEG. B/O weakness, mental states change. 8/9 home post neg LP, home 8/10.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Cough, Nasal congestion, Pyrexia, Rhinorrhoea, Viral infection
Clinical narrative: Fever 101.4 x 2 days 7/19/02 and 7/20/02, coughing, congestion, runny nose. Went to see MD in office on 7/20/02. Diagnosed as having viral infection and treated with Albuterol and breathing treatments x 1 week and amoxicillin po x 1 week. Mom called health dept 9/5/02. Rec'd call 9/5/02-she called back 9/9/02 mom states child completely recovered.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Breath holding, Screaming
Clinical narrative: Pt got vaccines DTaP/IPV/Comvax and Prevnar around 10:45am, cried with breath holding spells for long period till 3:30pm. Then calmed down.
Age: 1.0
Sex: F
Vaccine: MMR, PNC
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Child presents to nurse within 10-15 mins post injection. Redden area approx golf ball size with dime sized knot. inst. GM to adm. Benadryl dosage appropriate for wgt and size and Motrin.  A follow up report received 9/23/2002 adds: One vaccine at each site.
Age: 50.0
Sex: M
Vaccine: IPV, MEN, TYP, YF
Symptoms: Diarrhoea, Headache, Vision blurred
Clinical narrative: Typhoid fever vaccine on 8/21/02 9:55 unusual headache, blurred vision and diarrhea, bed ridden for at least 51x (6) hrs.
Age: 1.08
Sex: U
Vaccine: PNC
Symptoms: Discomfort, Dyspnoea, Hyperventilation, Injection site erythema, Injection site oedema
Clinical narrative: This is a 13 month old child presenting with difficulty breathing and skin reaction to vaccination. The child had noted a spot on the thigh from Tuesday vaccination, thus about 2 days ago. This has been reddened and swollen. They tried some Benadryl and Tylenol. Tonight there seemed to be an episode that was scary. It seemed like the breathing was hard and labored with perhaps some retractions. The child was fussy. The child had difficulty sleeping, but as soon as the child was picked up and evaluated she seemed to improve. There did not seem to be anything for sure that seemed to make her better such as taking her outside or any events, perhaps just comforting. Thus, she was brought in as this was scary and to review to see if this reaction has caused it. The child has had no fever. The child has been fussy because of the discomfort in the leg. The left thigh shows a 2x3 red injury with no flucturance, no streaking. There is no excessive heat to the area, but it is warm. the child is doing well now and will be discharged. Advised to continue to treatments they have been giving with Benadryl and Tylenol. She does not seem to require any antibiotics at this time. The breathing episodes seems transitory. This possibly could be a viral situation, but I think it is a little bit early to tell. Croup may also give this kind of situation, although there does not seem to be any clear entity of that either. Thus, I will send the child home with observation. Perhaps a vaporizer would help too. Final diagnoses: local reaction to immunization. Attack of dyspnea.
Age: 1.08
Sex: U
Vaccine: PNC
Symptoms: Injection site reaction, Insomnia
Clinical narrative: This is a 13 month old child presenting with difficulty breathing and skin reaction to vaccination. The child had noted a spot on the thigh from Tuesday vaccination, thus about 2 days ago. This has been reddened and swollen. They tried some Benadryl and Tylenol. Tonight there seemed to be an episode that was scary. It seemed like the breathing was hard and labored with perhaps some retractions. The child was fussy. The child had difficulty sleeping, but as soon as the child was picked up and evaluated she seemed to improve. There did not seem to be anything for sure that seemed to make her better such as taking her outside or any events, perhaps just comforting. Thus, she was brought in as this was scary and to review to see if this reaction has caused it. The child has had no fever. The child has been fussy because of the discomfort in the leg. The left thigh shows a 2x3 red injury with no flucturance, no streaking. There is no excessive heat to the area, but it is warm. the child is doing well now and will be discharged. Advised to continue to treatments they have been giving with Benadryl and Tylenol. She does not seem to require any antibiotics at this time. The breathing episodes seems transitory. This possibly could be a viral situation, but I think it is a little bit early to tell. Croup may also give this kind of situation, although there does not seem to be any clear entity of that either. Thus, I will send the child home with observation. Perhaps a vaporizer would help too. Final diagnoses: local reaction to immunization. Attack of dyspnea.
Age: 5.0
Sex: M
Vaccine: DTAP, HEP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: Mom noticed "redness and little swollen" last evening with c/o pain. Tylenol given with relief-no fever. Picked child up after school at 3:30pm with child c/o pain Rt arm. Tylenol given and noted reddened, swollen Rt upper arm on deltoid region. Local reaction "superficial reaction."
Age: 12.0
Sex: F
Vaccine: DT
Symptoms: Face oedema, Urticaria
Clinical narrative: 4 hours post dt developed hives and swollen lips required ? and ?. Now fine.
Age: 7.0
Sex: M
Vaccine: HEPA
Symptoms: Chest discomfort, Heart rate increased
Clinical narrative: Grandmother reports that family went shopping after leaving immunization clinic. Pt told her that his heart was beating fast and he felt like something was squeezing his heart. This was about 20 mins after vaccine administration. He ate a banana and was OK after two minutes. 9/11/02, family is consulting with MD regarding whether or not child should receive another one of this vaccine. Pt continues to be fine following this episode.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Pyrexia
Clinical narrative: Vaccines receved on 8/20-no reaction that evening. 8/21 in am had a sm bump at site of DTaP. Grew to apple size by that evening and leg extremely sore. Fever of 101.2. This am redness had increased up thigh through groin down in pubic area. No fever today and no soreness. Area is "rash like redness." Seen in ER MD recommended Benadryl and Tylenol.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Did not have a reaction the evening of immunizations. Had a small local reaction the next day and today spread up the thigh to public area. Parent states it was a "rash-like" redness. No other symptoms. Seen in ER
Age: 1.0
Sex: F
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Rash papular
Clinical narrative: Multiple pin point papules in 4-5cm square area surrounding injection site and on lateral arm. No crusting or infection, fixed in location.
Sex: F
Vaccine: DTAP, HEP, HEPA, IPV, MMR
Symptoms: Malaise, Pyrexia, Vomiting
Clinical narrative: Fever (103+) for 3.5 days, malaise, vomiting for 1 day.
Age: 17.0
Sex: F
Vaccine: HEP, HEPA, TD
Symptoms: Cellulitis, Injection site erythema, Injection site induration
Clinical narrative: Cellulitis of the left upper arm erythema and induration of the left upper arm
Age: 1.3
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Immunization given on 09/12/2002. Appt at 11:40 am, spoke with SSD, Conversation translated, Immunization given, DTaP to RAT, Varicella LLT, SSD reported right leg swollen, Site hot red, pain to touch.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Rash maculo-papular, Skin ulcer
Clinical narrative: Skin on right anterior thigh with scattered pink, maculopapular eruptions. Few lesions on trunk and bilateral cheeks.
Age: 55.0
Sex: F
Vaccine: MMR, TD
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Injection site pain, Pruritus
Clinical narrative: 08/23/2002 Pt come by the clinic complaining of pain, swelling, itching on left upper arm. Pt had TD shot last 08/16/2002. Observed swelling, redness on left upper arm, deltoid area. Pt stated back four years had antibiotic on arm, had some reactions. Advised pt to elevate arm and apply cold compresses on the site where redness and swelling. Advised pt if symptoms get worse see PMD for evaluation.
Age: 1.6
Sex: M
Vaccine: DTAP, MMR
Symptoms: Urticaria
Clinical narrative: Hives, no SOB. Atarax.
Age: 64.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Feeling hot, Pruritus, Urticaria
Clinical narrative: Td done 9/7/02. Sore on 9/8/02. 9/11/02 had several little red spots. 9/12/02 had several small whelps and itching. 9/13/02 5" x 7" red whelp, hot to touch. Pt to use Benadryl, Tylenol, and ice to area. To f/u with MD as needed.
Age: 3.2
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Eye movement disorder, Fall, Pyrexia, Tremor
Clinical narrative: Mother reports at 7:15pm on 8/29/02. Child was outside playing. Fell to the ground, began shaking eyes rolled back, slobbering, temp 102 deg, took to ER. MD stated to mother could have been vaccine related. States doing well today.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Vaccine given on 9/13/02 presented on 9/16/02 with a two inch circular erythema and induration warm to touch.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Fall, Syncope
Clinical narrative: Pt received Recombivax 1cc IM (1st of two dose series) hep B vaccine-tolerated well. Apparently walked out of nurse's office at school where given and "faints" in hallway. She did not lose consciousness, but fell to floor without injuring herself brought to nurse's office in wheel chair by asst principal within minutes of event. States she feels "OK" OT 97.2 P 80 R 18 BP 120/70. Mother notified states child has fainted previously after receiving vaccines because "she is afraid of shots." Child rested in nurse's room until mother came to take her home. Mother and child to always tell practitioner her history before receiving shots. Suggested she receive 2nd hep B at PMD.
Age: 2.2
Sex: F
Vaccine: DTAP, HBHEPB
Symptoms: Injection site erythema, Irritability
Clinical narrative: Patient came to office 2 days post immunizations (given 09/05/2002) in office 09/07/02. Had 5 cm reddened area around DTaP injection site, Pt was "whiney". No Temp, No Tx.
Age: 4.7
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: L shoulder area swollen, red and hot to touch. Mother states pt c/o pain and itching in area.
Age: 4.7
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Pruritus
Clinical narrative: L shoulder area swollen, red and hot to touch. Mother states pt c/o pain and itching in area.
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Fatigue, Palpitations, Vertigo
Clinical narrative: Vertigo, palpitations, fatigue.
Sex: U
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site pain, Injection site reaction
Clinical narrative: Cellulitis, painful to touch, afebrile since immunization x 2 days ago. Keflex 250mg po tid x 10 days. f/U PRN. R arm.
Age: 4.2
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site pain, Rash erythematous, Rash macular
Clinical narrative: Blotchy erythematous macular rash on R anterior thigh with tender injection site.
Sex: M
Vaccine: HEP
Symptoms: Agitation, Anorexia, Crying, Weight decreased
Clinical narrative: Baby latching on and well until time of hep B shot. Then slept virtually from ~ 2 1/2 hrs later until 14 1/2 hrs later since then screaming, won't nurse, lost wt. Mother w/excellent supply of milk, pumping for baby now. Baby regaining wt w/ syringe feeds 48 hrs after vax given.
Age: 0.9
Sex: F
Vaccine: HIBV, IPV, VARCEL
Symptoms: Coordination abnormal, Gait disturbance, Hypotonia, Loss of consciousness
Clinical narrative: Ataxia, falling, repeated loss of tone of lower limbs, broad based gait, hyperlordotiz stance from 4 d after vax till ~5-6 d later (duration < 1wk).
Sex: F
Vaccine: HEP
Symptoms: Decreased appetite, Depressed level of consciousness, Lethargy, Vomiting
Clinical narrative: Marked lethargy with poor feeding 1/2 volume, spitting up yellow-green, barely arousable, lasted ~ 4 hrs.
Age: 1.08
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema, Infection, Pruritus, Rash maculo-papular
Clinical narrative: 9/12/02 red, raised areas, itching. 9/16/02 scabbed sores, resolving atypical varicella.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Eye oedema, Injection site oedema
Clinical narrative: Localized swelling LUE red with edema. Some puffiness and edema under L eye.
Age: 68.0
Sex: F
Vaccine: PPV, TD
Symptoms: Asthenia, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Swelling on imms site, redness, pain, tiredness, weak.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Dysphagia, Dyspnoea, Pyrexia, Tremor
Clinical narrative: Pt woke at 1am with shakes and temp 106.8. Temp decreased 102.6 to 100.9 in am. Some dyspnea and diff. swallowing. ER in am after calling MD office.
Age: 1.64
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Pyrexia
Clinical narrative: 20 m/o with temp of 101 with redness just below site of injection + edema, warm to touch (L thigh) 4-5cm area. Placed on Keflex (250/5) 4ml TID X 10 days. RTC for f/u.
Age: 35.0
Sex: M
Vaccine: TTOX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Patient developed Guillian Barre Syndrome
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB
Symptoms: Crying, Irritability, Pyrexia
Clinical narrative: Received DTAP and HIB/Hep B 9/17/02 pm.  By 9pm child's rectal temp was over 102(child was too irritable to leave thermometer in long enough for accurate temp)after receiving Tylenol at 7pm.  Child very irritable, crying, difficult to console.  Mom states child was somewhat irritable and had fever for several hours after first DTAP.  No redness or swelling at the sites of injections.
Age: 10.0
Sex: M
Vaccine: HEPA
Symptoms: Oedema, Pruritus, Rash papular
Clinical narrative: Child was given HAV vaccine on Friday, September 13, 2002.  Developed pruritic, papular rash, starting on ears, spreading over entire body.  Rash began day after vaccine was administered.  Also had some swelling of ears and cheeks. Per 60 day follow up: Unknown if pt recovered.
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Skin nodule
Clinical narrative: Approx. 1 week after immunization with hep B #2, pt. noted several individual tender red nodules on anterior lower legs.  Progressive increase in number and tenderness.  Denies puritis.  No report of fever, arthralgias prior to outbreak.  (Nodules) do not blanch. Annual follow up on 12/02/03: "Vaccine recipient has recovered from the adverse events that were reported for this vaccination.  11/21/03: Per phone call to mother on 11/03/03, pt was completely recovered.  Has elected to not get #3 hep b dose."
Age: 25.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Injection site induration, Injection site pain
Clinical narrative: area of eryth(ema), induration and tenderness at injection site.
Age: 1.3
Sex: F
Vaccine: HIBV, VARCEL, HIBV, VARCEL
Symptoms: Cough, Dyspnoea, Eye swelling, Generalised oedema, Skin discolouration
Clinical narrative: Information has been received from a physician concerning a "healthy" 16 month old white female with no known allergies or prior medical history who was vaccinated on 8/20/02 with a first dose of varicella virus vaccine live (lot 0202M) in the left thigh. Concomitant vaccination on 8/20/02 included a second dose of HIB conjugate vaccine (lot UA700AA) in the left thigh. There was no illness at the time of vaccination. On 7/30/02, the child was vaccinated with a second dose of Infanrix (lotU0824_ in the right thigh and with a third dose of poliovirus vaccine (lot 553A2) in the left thigh. There was no other concomitant medication. It was reported that the child had no adverse reaction with the first dose of HIB conjugate vaccine. On 8/20/02, approximately six to eight hours after administration, at 20:30pm, the child developed an anaphylactic reaction becoming flushed with generalized edema and her eyes swollen totally shut and a fever of 101-103F that lasted 48 hours. The child did not have a cough or shortness of breath. On 8/21/02, the child still had a fever of 101F. The child was hospitalized overnight and had fully recovered by 8/22/02. Additional info has been requested.
Age: 1.3
Sex: F
Vaccine: HIBV, VARCEL, HIBV, VARCEL
Symptoms: Swelling face
Clinical narrative: Information has been received from a physician concerning a "healthy" 16 month old white female with no known allergies or prior medical history who was vaccinated on 8/20/02 with a first dose of varicella virus vaccine live (lot 0202M) in the left thigh. Concomitant vaccination on 8/20/02 included a second dose of HIB conjugate vaccine (lot UA700AA) in the left thigh. There was no illness at the time of vaccination. On 7/30/02, the child was vaccinated with a second dose of Infanrix (lotU0824_ in the right thigh and with a third dose of poliovirus vaccine (lot 553A2) in the left thigh. There was no other concomitant medication. It was reported that the child had no adverse reaction with the first dose of HIB conjugate vaccine. On 8/20/02, approximately six to eight hours after administration, at 20:30pm, the child developed an anaphylactic reaction becoming flushed with generalized edema and her eyes swollen totally shut and a fever of 101-103F that lasted 48 hours. The child did not have a cough or shortness of breath. On 8/21/02, the child still had a fever of 101F. The child was hospitalized overnight and had fully recovered by 8/22/02. Additional info has been requested.
Age: 1.3
Sex: F
Vaccine: HIBV, VARCEL, HIBV, VARCEL
Symptoms: Anaphylactic reaction, Eye swelling, Hot flush, Oedema, Pyrexia
Clinical narrative: Information has been received from a physician concerning a "healthy" 16 month old white female with no known allergies or prior medical history who was vaccinated on 8/20/02 with a first dose of varicella virus vaccine live (lot 0202M) in the left thigh. Concomitant vaccination on 8/20/02 included a second dose of HIB conjugate vaccine (lot UA700AA) in the left thigh. There was no illness at the time of vaccination. On 7/30/02, the child was vaccinated with a second dose of Infanrix (lotU0824_ in the right thigh and with a third dose of poliovirus vaccine (lot 553A2) in the left thigh. There was no other concomitant medication. It was reported that the child had no adverse reaction with the first dose of HIB conjugate vaccine. On 8/20/02, approximately six to eight hours after administration, at 20:30pm, the child developed an anaphylactic reaction becoming flushed with generalized edema and her eyes swollen totally shut and a fever of 101-103F that lasted 48 hours. The child did not have a cough or shortness of breath. On 8/21/02, the child still had a fever of 101F. The child was hospitalized overnight and had fully recovered by 8/22/02. Additional info has been requested.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, UNK
Symptoms: Injection site erythema, Injection site mass, Rash, Sudden infant death syndrome
Clinical narrative: June 27--received shot and developed rash on trunk of body and red lump at injection site. (Husband saw rash). June 28--Saw rash before giving baby (Mother saw rash). June 29--took child to hospital. Doctor mentioned rash but gave no treatment and doctor did not look rash or injection site. SIDS.
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: Information has been received from a physician concerning a male (age not given), who was vaccinated on an unknown date with a dose of MMR vaccine live (second generation) (lot # not given). At the time of vaccination the patient had an unknown immune deficiency. Following vaccination, the patient developed a morbilliform rash and fever, got better, then developed another morbilliform rash and fever for 3-4 days, the a serious illness. The patient had been diagnosed on an unknown date with hematophagocytic syndrome, and Epstein Barr virus was found. The patient had also been hospitalized on an unknown date. The patient died (cause unknown) on an unknown date. It was noted that this case took place some years ago, and had to do with a child. Morbilliform rash, fever, serious illness, hematophagocytic syndrome, Epstein Barr virus and the unknown cause of death were considered to be immediately life-threatening. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Drug ineffective, Febrile convulsion, Sepsis, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 6 month old female who was vaccinated with a dose of Haemophilus B conjugate vaccine (manufacturer unknown). Subsequently, two weeks after vaccination the patient developed febrile seizures, and was also found to have urosepsis after a sepsis workup. The patient's cerebrospinal fluid immunology and serology studies were positive for Haemophilus influenza B, with weak agglutination. The cerebrospinal fluid cultures however were negative. The reporter considered the patient's experiences to be important medical events. No further information is available.
Age: 10.0
Sex: M
Vaccine: RAB
Symptoms: Anaphylactic reaction, Erythema, Hyperhidrosis, Hyperventilation
Clinical narrative: A 10 yr old normal healthy male child was bitten (category 1) by a stray dog around the knee region on April 06, 1999. 10-15 mins after the bite wound, toilet  was performed with soapwater and antiseptic. Pt was administered 1st dose of Rabipur (batch number unknown) for postexposure prophylaxis. Within 5 mins after the injection he developed an anaphylactic/araphyfactoid reaction (fall in pulse rate and blood pressure, heavy breathing, sewating and redness) which lasted for 10-15 mins. The pt recovered after treatmen with Adrenaline 1 ampoule,s.c.(adrenaline bitartrale 1.8 mg) and one vial of Efcortin i.v. (hydrocortisone 100mg). The pt was kept under observation for 2 hours in a hospital and then sent home. The vaccination series was continued with a different (HDC) vaccine. The pt did not like eggs. Preliminary assessment; Seriousness-criterion; life threatening. Causality; not to exclude.
Sex: U
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a doctor of pharmacy concerning a patient (age and gender not given) who was vaccinated on an unknown date with a dose of MMR vaccine live (second generation) (lot # not given). Subsequently the patient developed autism. The reporter had no details about the patient or the experience. It was unknown if the patient sought medical attention. Upon internal review, autism was considered to be an other important medical event. Additional information has been requested.
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Autism
Clinical narrative: Information has been received from a registered nurse concerning a male patient, approximately 3 years old at the time of this report, who on 11/02/00 was vaccinated with a dose of MMR vaccine live (second generation) (lot number not given) and a dose of varicella virus vaccine live (lot # not given). On 12/3/99, 1/26/00 and 7/19/00, the patient was vaccinated with a first (lot #633792/1672J), second (lot #633793/1673J), and third (lot #636121/0497K) dose of hepatitis B vaccine recombinant (yeast). Concomitant therapy included diphtheria toxoid/ pertussis vaccine/teta (manufacturer unknown) and poliovirus vaccine (manufacturer unknown) given on unknown dates. The reporter stated that the patient had been vaccinated with several vaccines and developed autism. The reporter was questioning if thimerosal was in any of the vaccines given and when thimerosal free hepatitis B vaccine recombinant (yeast) was available in adolescent dosing. The reporter was uncomfortable giving any other information about the patient because the mother of the child is already upset. Unspecified medical attention was sought. Follow up information received from the registered nurse indicated that she had called the manufacturers for information on the thimerosal content contained in the normal childhood vaccines that children receive. The reporter further stated that regarding this case, they are not pinpointing the vaccines to be the cause of the child's autistic diagnosis. The patient's mother and physician were just curious to know the thimerosal content of the vaccines. The reporter did not feel comfortable releasing any further information on this child and stated that the mother of this child has enough to deal with at this time. Upon internal review, autism was determined to be an other important medical event. Additional information has been requested. Follow up info received from the registered nurse indicted that she had contacted the company only to "question thimerosal in vaccines." The reporter stated that the physician "does not want any further exploring of this matter." Additional info is not expected.
Sex: F
Vaccine: HEP
Symptoms: Abnormal behaviour, Cognitive disorder, Drug toxicity, Drug withdrawal syndrome, Nervous system disorder
Clinical narrative: Information has been received regarding a case in litigation concerning a female child who was vaccinated IM with a first and second dose of hep B vaccine on 10/23/97 (lot 624813/1190K) and 2/20/98 (lot 623501/0745E). Concomitant therapy included globulin, immune administered as intrauterine injections to the child's mother during pregnancy, a first, second, third and fourth dose of Tetramune on 8/21/97 (lot 445-539), 10/23/97 (lot 446-956), 12/10/97 (lot 447-832) and 7/7/99 (lot 462-314) and a first, second, third and fourth dose of HIB conjugate vaccine IM on 8/21/97 (lot M235RA), 10/23/97 (lot M265RE), 12/10/97 (lot M26085) and 9/15/98 (lot M240RL). It is alleged that the child has suffered devastating injuries through mercury toxicity and associated complications and sequelae and the aggravation of other conditions directly through exposure via intramuscular injections of mercury. It is also alleged that at approximately 28 months of age, in approximately September 2000, that the child was neurologically devastated by the accumulation of mercury in his body, having been exposed via intramuscular vaccinations and intrauterine injections his mother received during pregnancy and suddenly regressed developmentally, losing milestones of neurological development previously achieved, specifically including, but not limited to becoming withdrawn, unable to speak, unresponsive to his environment, engaging in repetitive behavior, loss of language skills, loss of motor skills and loss of affect. It is further alleged that the child experienced exposure during pregnancy. This is an amended report. Mercury toxicity , which was previously reported in the narrative only, has been added as an adverse event. Upon internal review, devastating injuries, associated complications and sequelae, aggravation of other conditions, neurologically devastated, suddenly regressed developmentally, losing milestones of neurological development, becoming withdrawn, unable to speak, unresponsive to his environment, engaging in repetitive behavior, loss of language skills, loss of motor skills and loss of affect were considered to be other medical events. No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Neurodevelopmental disorder
Clinical narrative: Information has been received regarding a case in litigation concerning a female child who was vaccinated IM with a first and second dose of hep B vaccine on 10/23/97 (lot 624813/1190K) and 2/20/98 (lot 623501/0745E). Concomitant therapy included globulin, immune administered as intrauterine injections to the child's mother during pregnancy, a first, second, third and fourth dose of Tetramune on 8/21/97 (lot 445-539), 10/23/97 (lot 446-956), 12/10/97 (lot 447-832) and 7/7/99 (lot 462-314) and a first, second, third and fourth dose of HIB conjugate vaccine IM on 8/21/97 (lot M235RA), 10/23/97 (lot M265RE), 12/10/97 (lot M26085) and 9/15/98 (lot M240RL). It is alleged that the child has suffered devastating injuries through mercury toxicity and associated complications and sequelae and the aggravation of other conditions directly through exposure via intramuscular injections of mercury. It is also alleged that at approximately 28 months of age, in approximately September 2000, that the child was neurologically devastated by the accumulation of mercury in his body, having been exposed via intramuscular vaccinations and intrauterine injections his mother received during pregnancy and suddenly regressed developmentally, losing milestones of neurological development previously achieved, specifically including, but not limited to becoming withdrawn, unable to speak, unresponsive to his environment, engaging in repetitive behavior, loss of language skills, loss of motor skills and loss of affect. It is further alleged that the child experienced exposure during pregnancy. This is an amended report. Mercury toxicity , which was previously reported in the narrative only, has been added as an adverse event. Upon internal review, devastating injuries, associated complications and sequelae, aggravation of other conditions, neurologically devastated, suddenly regressed developmentally, losing milestones of neurological development, becoming withdrawn, unable to speak, unresponsive to his environment, engaging in repetitive behavior, loss of language skills, loss of motor skills and loss of affect were considered to be other medical events. No further information is available.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Cyanosis, Hypoaesthesia, Hypokinesia, Injection site hypersensitivity
Clinical narrative: Information has been received from a medical office concerning a 49 year old male with *no known drug allergies and* a history of epilepsy, mitral valve proloapse and aortic insufficiency with aortic valve replacement, who on 8/27/02 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent in his right arm. In the early morning of 8/28/02 the pt developed rigors, a 104.9 degree fever (also reported as 105), injection site pain and swelling, cyanotic nail beds and was unable to move his right arm. On 8/29/02 the pt was seen in the doctor's office where IV fluids were administered and the pt was then sent to the ER. Blood cultures taken in the ER were negative for growth and the pt was released. As of 9/3/02 the pt's adverse experiences had not abated. As of 9/6/02 the nurse reported that his recovery status was unknown. *As of 11/26/02, the PT's recovery status was not known. It was also reported that the PT had right shoulder pain, numbness and tingling in both hands, and inject site redness.* The pt's experiences *of rigors, fever, inject site pain and swelling, cyanotic nail beds, and being unable to move his right arm* were considered to be disabling by the reporter. Additional info has been requested.  Follow up on 07/08/2003: "Follow up information was received from the RN. On 05/09/2003, the patient was seen and the "reaction to shot has resolved".  The patient's experiences of rigors, fever, injection site pain and swelling, cyantonic nail beds, and being unable to move his right arm were considered to be disabling by the reporter.  Additional information is not expected."
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Injection site oedema, Injection site pain, Paraesthesia, Paralysis, Pyrexia
Clinical narrative: Information has been received from a medical office concerning a 49 year old male with *no known drug allergies and* a history of epilepsy, mitral valve proloapse and aortic insufficiency with aortic valve replacement, who on 8/27/02 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent in his right arm. In the early morning of 8/28/02 the pt developed rigors, a 104.9 degree fever (also reported as 105), injection site pain and swelling, cyanotic nail beds and was unable to move his right arm. On 8/29/02 the pt was seen in the doctor's office where IV fluids were administered and the pt was then sent to the ER. Blood cultures taken in the ER were negative for growth and the pt was released. As of 9/3/02 the pt's adverse experiences had not abated. As of 9/6/02 the nurse reported that his recovery status was unknown. *As of 11/26/02, the PT's recovery status was not known. It was also reported that the PT had right shoulder pain, numbness and tingling in both hands, and inject site redness.* The pt's experiences *of rigors, fever, inject site pain and swelling, cyanotic nail beds, and being unable to move his right arm* were considered to be disabling by the reporter. Additional info has been requested.  Follow up on 07/08/2003: "Follow up information was received from the RN. On 05/09/2003, the patient was seen and the "reaction to shot has resolved".  The patient's experiences of rigors, fever, injection site pain and swelling, cyantonic nail beds, and being unable to move his right arm were considered to be disabling by the reporter.  Additional information is not expected."
Age: 1.5
Sex: F
Vaccine: DTAP, HEP
Symptoms: Antisocial behaviour, Autism, Cognitive disorder, Drug toxicity, Drug withdrawal syndrome
Clinical narrative: This report describes the occurrence of pervasive developmental disorder NOS in an 18 month old female who was vaccinated with hepatitis B vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings and has not been verified by a physician or other healthcare professional. The subject's mother received the (D) immune globulin on 9/30/96, when the subject was in utero. Reportedly, the subject was "born a perfectly normal, healthy baby girl whose APGAR scores at birth were well within the normal range (9 and 10). " The subject's attorney alleged that "Developmentally, neurologically and socially the subject achieved every developmental milestone anticipated of all normally developing children." Specifically, at 2 months of age, she was alert, cooed, responded to sounds, responded to others, and started to recognize and interact with her parents. At 6 months, she spoke" sounds that formed parts of words" and reportedly she was "behaviorally appropriate to her environment, her parents, other children and toys." At 15 months, she said "many words and sentences." The subject received Engerix B on 12/17/96 (lot number not provided), 2/13/97 (lot number not provided) and 6/19/97 (lot number not provided). She also received inactivated poliomyelitis virus vaccine (IPOL), oral poliomyelitis virus vaccine, Haemophilus influenzae type B conjugate vaccine 2/13/97, diphtheria and tetanus toxodis and pertussis vaccine adsorbed 2/13/97, diphtheria ad tetanus toxoids and acellular pertussis vaccine adsorbed 4/13/97, 6/19/97 and 6/18/98, varicella virus vaccine 12/18/97, and MMR II 3/19/98. On 9/9/02, the subject's attorney alleged that, at 18 months, the subject "suddenly regressed developmentally, losing milestones of neurological development previously achieved." She was "withdrawn, unable to speak and unresponsive to her environment." Additionally, she "could no longer maintain eye contact with those around her, could no longer point her finger to recognized items and could no longer interact with her mother and father and others in her environment." The attorney further alleged that the subject's "injuries included the loss of language skills, motor skills and affect." The attorney alleged that the subject "was poisoned with 192.5 micrograms of toxic mercury from the vaccines containing thimerosal." The attorney stated that the subject "has been diagnosed with an autism spectrum disorder: pervasive developmental disorder, not otherwise specified." This report of pervasive developmental disorder NOS  is considered medically serious.
Age: 1.5
Sex: F
Vaccine: DTAP, HEP
Symptoms: Nervous system disorder, Neurodevelopmental disorder
Clinical narrative: This report describes the occurrence of pervasive developmental disorder NOS in an 18 month old female who was vaccinated with hepatitis B vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings and has not been verified by a physician or other healthcare professional. The subject's mother received the (D) immune globulin on 9/30/96, when the subject was in utero. Reportedly, the subject was "born a perfectly normal, healthy baby girl whose APGAR scores at birth were well within the normal range (9 and 10). " The subject's attorney alleged that "Developmentally, neurologically and socially the subject achieved every developmental milestone anticipated of all normally developing children." Specifically, at 2 months of age, she was alert, cooed, responded to sounds, responded to others, and started to recognize and interact with her parents. At 6 months, she spoke" sounds that formed parts of words" and reportedly she was "behaviorally appropriate to her environment, her parents, other children and toys." At 15 months, she said "many words and sentences." The subject received Engerix B on 12/17/96 (lot number not provided), 2/13/97 (lot number not provided) and 6/19/97 (lot number not provided). She also received inactivated poliomyelitis virus vaccine (IPOL), oral poliomyelitis virus vaccine, Haemophilus influenzae type B conjugate vaccine 2/13/97, diphtheria and tetanus toxodis and pertussis vaccine adsorbed 2/13/97, diphtheria ad tetanus toxoids and acellular pertussis vaccine adsorbed 4/13/97, 6/19/97 and 6/18/98, varicella virus vaccine 12/18/97, and MMR II 3/19/98. On 9/9/02, the subject's attorney alleged that, at 18 months, the subject "suddenly regressed developmentally, losing milestones of neurological development previously achieved." She was "withdrawn, unable to speak and unresponsive to her environment." Additionally, she "could no longer maintain eye contact with those around her, could no longer point her finger to recognized items and could no longer interact with her mother and father and others in her environment." The attorney further alleged that the subject's "injuries included the loss of language skills, motor skills and affect." The attorney alleged that the subject "was poisoned with 192.5 micrograms of toxic mercury from the vaccines containing thimerosal." The attorney stated that the subject "has been diagnosed with an autism spectrum disorder: pervasive developmental disorder, not otherwise specified." This report of pervasive developmental disorder NOS  is considered medically serious.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Aphasia
Clinical narrative: Stopped talking
Sex: M
Vaccine: HIBV
Symptoms: Growth retardation, Weight decreased
Clinical narrative: Lost 1.5 lbs, Failure to thrive, Hospitalized X 1 week
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, PNC, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Silver dollar size swelling. Baseball size redness. No fever; no drainage. Treated with cool compress and Motrin.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Rash around 21 days. Fluid drained from knee 09/04/2002.
Age: 6.0
Sex: M
Vaccine: TTOX
Symptoms: Diarrhoea, Injection site swelling, Malaise, Pain
Clinical narrative: Upper arm injection site swollen to size of small apple. Malaise (body aches). Diarrhea.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Dyspnoea, Pyrexia, Rash
Clinical narrative: 1-2 days after shots, pt broke out in rash, fever, and slight trouble breathing. No Rx acc. to grandma.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site reaction, Myalgia, Pyrexia, Vomiting
Clinical narrative: 1 day later, patient with myalgia, fever, vomiting, headache. Also with 14.5cmx15cm area at injection site.
Age: 40.0
Sex: F
Vaccine: TD, TYP
Symptoms: Erythema, Influenza like illness, Lethargy, Pyrexia, Urticaria
Clinical narrative: About 8:20 AM on 9/16/02, spouse telephoned and reported that 24 hours after his wife received her immunizations, she developed a large, red welt at injection site, low grade temperature and flu-like symptoms, lethargy.