chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: The patient developed erythema and swelling of the left thigh at the injection site beginning 24 hours after administration of vaccines.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Oedema peripheral
Clinical narrative: Post vax the patient developed a very large local reaction with significant upper extremity edema and erythema. The patient was treated with Motrin, Benadryl and Keflex.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Rash
Clinical narrative: Rash on leg approximately 1/2 hour after receiving TD injection, 08/27/2001. By 09/04/2001, rash had spread to legs, arm, neck and face. Course of Allegra not helpful. Two courses of Prednisone and Atovax controlled symptoms but rash returned on 10/08/2001 after 1 week of stopping meds.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Right upper arm has red, swollen, hot area 4 inches by 2.5 inches with bruising.
Age: 4.0
Sex: F
Vaccine: HEPA, IPV, VARCEL
Symptoms: Blister, Erythema, Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Vaccine given 09/26/2001. Pt presents 10/11/2001 with 1 day history of localized swelling and erythema to right triceps. Multiple small resicular lesions to arms, buttock, ear, neck from day 13 PV. Triceps very warm, red and pruritic.
Age: 4.0
Sex: F
Vaccine: HEPA, IPV, VARCEL
Symptoms: Pruritus
Clinical narrative: Vaccine given 09/26/2001. Pt presents 10/11/2001 with 1 day history of localized swelling and erythema to right triceps. Multiple small resicular lesions to arms, buttock, ear, neck from day 13 PV. Triceps very warm, red and pruritic.
Age: 15.0
Sex: F
Vaccine: DT, HEP, MMR
Symptoms: Difficulty in walking, Headache, Muscle spasms, Muscular weakness, Myalgia
Clinical narrative: Post vax the patient complained of myalgias, diffuse paresthesis in the lower extremeties, a headache, nausea, weakness in her legs and difficulty ambulating. Lab work was OK. The patient had a marked muscle spasm.
Age: 15.0
Sex: F
Vaccine: DT, HEP, MMR
Symptoms: Nausea, Paraesthesia
Clinical narrative: Post vax the patient complained of myalgias, diffuse paresthesis in the lower extremeties, a headache, nausea, weakness in her legs and difficulty ambulating. Lab work was OK. The patient had a marked muscle spasm.
Age: 10.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Injection site hypersensitivity, Rash macular
Clinical narrative: Post vax the patient develeoped a macular rash at the injection site, on her upper chest and the top of bilateral arms and shoulders. The patient was treated with Benadryl.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Decreased appetite, Fatigue, Myalgia
Clinical narrative: Post vax, the patient experienced myalgia, fatigue and a decrease in appetite.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Approximately 2 hours post vax the patient developed a big knot at the injection site. The area was very red and itched. That evening the arm was very swollen to the elbow, red, hot to touch and itched. The patient could not remove her rings and her ankles were also swollen. The patient was treated with Benadryl and cold compresses.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Joint swelling, Pruritus
Clinical narrative: Approximately 2 hours post vax the patient developed a big knot at the injection site. The area was very red and itched. That evening the arm was very swollen to the elbow, red, hot to touch and itched. The patient could not remove her rings and her ankles were also swollen. The patient was treated with Benadryl and cold compresses.
Age: 5.0
Sex: F
Vaccine: DTAP, HEP, IPV, MMR
Symptoms: Convulsion, Pyrexia
Clinical narrative: Two weeks post vax, pt experienced fever as high as 103F for three days. Each evening of these 3 days, the pt had 1-2 seizures. Pt's mother describes these seizures as similar in character to previous epileptic seizures the child has experienced.
Age: 10.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Fatigue, Gait disturbance, Joint swelling, Red blood cell sedimentation rate increased
Clinical narrative: Pt began having aching joints in fingers. To date, this has progressed to knees, ankles, wrists, and 1 shoulder with some swelling in the joints. She also has fatigue. Pt has been limping for 9 days. Pt's MD does not know enough about her symptoms and referred pt to a rheumatologist. Pt takes ibuprofen daily.
Age: 37.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Dyspnoea, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt complained of "so much drainage" in her throat and chest and had labored breathing. This started the day after immunizations were given and lasted 8 days. She took a decongestant for this. Four days, post vax, she noticed a tiny "knot" under the site of MMR injection and this has been getting bigger each day. It is hot to touch, tender, swollen and red.
Age: 37.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Upper respiratory tract infection
Clinical narrative: Pt complained of "so much drainage" in her throat and chest and had labored breathing. This started the day after immunizations were given and lasted 8 days. She took a decongestant for this. Four days, post vax, she noticed a tiny "knot" under the site of MMR injection and this has been getting bigger each day. It is hot to touch, tender, swollen and red.
Age: 2.6
Sex: M
Vaccine: HEPA
Symptoms: Dyspnoea, Pyrexia
Clinical narrative: The pt developed a temperature of 103F and shortness of breath.
Sex: U
Vaccine: HEP, MMR
Symptoms: Optic neuritis retrobulbar, Vision blurred
Clinical narrative: Pt was given a Hep-B and MMR on 8/16/01. On 9/26/01, she developed a unilateral blurry vision and was subsequently dx'd with retrobulbar neuritis. This was transient (about 2 weeks).
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: On 10/1/01, pt had left neck stiffness; soreness at site of injection since 9/2/01 which is better now but still has some pain on left neck and upper shoulder. #2 given today. Pt also had TB skin test ID in the RA, 1 previously.
Age: 1.8
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Crying, Tremor, Vomiting
Clinical narrative: 20 minutes, post vax, the pt had uncontrollable crying. He threw up during this fit. He had a shaking episode for a few minutes where his arms were quivering.
Age: 5.4
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Urticaria
Clinical narrative: Blotchy hives on neck and chest at 15:00. 3 1/2 hours, post vax, mother of child gave Benadryl according to package for child's weight and mom said 1/2 tsp of liquid Benadryl.
Age: 1.0
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Platelet count decreased, Thrombocytopenic purpura
Clinical narrative: ITP; on Winrho.
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Candidiasis, Haematocrit decreased, Haemoglobin decreased, Pyrexia, Upper respiratory tract infection
Clinical narrative: History of a fever of 106.4F, 6 days after vaccine administered. History of thrush and URI.
Age: 5.6
Sex: M
Vaccine: DTAP, IPV
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: On 11/14/00, the pt had a temperature of 101.5F, nausea and vomiting. On 4/23/01, gave pt Pediatric DT in right arm and pt developed a raised whelp with redness.
Age: 56.0
Sex: F
Vaccine: LYME
Symptoms: Chest pain, Chills, Nausea, Pyrexia, Tremor
Clinical narrative: 2 hrs after vaccination had shaking chills, some chest pressure. For the next 2 days nausea and hot and cold.
Age: 51.0
Sex: M
Vaccine: HEP, HEPA, HEP
Symptoms: Disturbance in attention, Dizziness, Fatigue, HIV infection, Lymphadenopathy
Clinical narrative: On 9/28/01, noted "grey" vision at inferior fields of right eye. The pt noted dizziness, light-headedness and blurry vision transiently while exercising 1 week prior to admission and which resolved after several minutes. He also had some ill-defined mild decrease in concentration skills and general fatigue up recently. On 10/01/01 seen by an ophthalmologist and dx'd with bilateral papillitis (left worse than right). Neck had bilateral modest lymphadenopathy. Bilateral optic neuritis thought to be vaccine associated. He was seen in follow-up as an outpt on 10/12/01 and noted some very minor improvement in visual acuity. He will continue to be followed by his ophthalmologist and PCP.
Age: 51.0
Sex: M
Vaccine: HEP, HEPA, HEP
Symptoms: Optic neuritis, Red blood cell sedimentation rate increased, Scotoma, Vision blurred, Visual field defect
Clinical narrative: On 9/28/01, noted "grey" vision at inferior fields of right eye. The pt noted dizziness, light-headedness and blurry vision transiently while exercising 1 week prior to admission and which resolved after several minutes. He also had some ill-defined mild decrease in concentration skills and general fatigue up recently. On 10/01/01 seen by an ophthalmologist and dx'd with bilateral papillitis (left worse than right). Neck had bilateral modest lymphadenopathy. Bilateral optic neuritis thought to be vaccine associated. He was seen in follow-up as an outpt on 10/12/01 and noted some very minor improvement in visual acuity. He will continue to be followed by his ophthalmologist and PCP.
Age: 51.0
Sex: M
Vaccine: HEP, HEPA, HEP
Symptoms: Disturbance in attention, Dizziness, Fatigue, Lymphadenopathy, Optic neuritis
Clinical narrative: On 9/28/01, noted "grey" vision at inferior fields of right eye. The pt noted dizziness, light-headedness and blurry vision transiently while exercising 1 week prior to admission and which resolved after several minutes. He also had some ill-defined mild decrease in concentration skills and general fatigue up recently. On 10/01/01 seen by an ophthalmologist and dx'd with bilateral papillitis (left worse than right). Neck had bilateral modest lymphadenopathy. Bilateral optic neuritis thought to be vaccine associated. He was seen in follow-up as an outpt on 10/12/01 and noted some very minor improvement in visual acuity. He will continue to be followed by his ophthalmologist and PCP.
Age: 51.0
Sex: M
Vaccine: HEP, HEPA, HEP
Symptoms: Vision blurred, Visual disturbance
Clinical narrative: On 9/28/01, noted "grey" vision at inferior fields of right eye. The pt noted dizziness, light-headedness and blurry vision transiently while exercising 1 week prior to admission and which resolved after several minutes. He also had some ill-defined mild decrease in concentration skills and general fatigue up recently. On 10/01/01 seen by an ophthalmologist and dx'd with bilateral papillitis (left worse than right). Neck had bilateral modest lymphadenopathy. Bilateral optic neuritis thought to be vaccine associated. He was seen in follow-up as an outpt on 10/12/01 and noted some very minor improvement in visual acuity. He will continue to be followed by his ophthalmologist and PCP.
Age: 0.2
Sex: F
Vaccine: HBHEPB, IPV, HBHEPB, IPV
Symptoms: Blood glucose increased, CSF test abnormal, Convulsion, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: This report is concerning a 9 week old female pt who on 9/19/01 was vaccinated with a dose of haemophilus b conjugate vaccine (+) hepatitis b vaccine recombinant (yeast). Secondary suspect therapy included an IV 160mg per 1 dose of ceftriaxone sodium (Rocephin), a dose of poliovirus vaccine. On 9/19/01, in the morning, post vax, the pt returned home from the pediatrician and vomited. At approx. 16:50, the pt was taken to the ER. She had a fever of 102.6F; pulse was 178 and respirations were 40. It was reported that sepsis was to be ruled out. At approx. 21:00, the pt commenced ceftriaxone sodium (Rocephin) 160mg IV reconstituted with 1 ml of dextrose (D5W) placed into a 500cc bag of dextrose (+) sodium chloride (D5 & 1/3NS) for 1 dose. This was administered through a Soluset. 5 minutes following the administration of Rocephin, the pt turned gray and was relocated to the resuscitation table. The pt went into a generalized tonic seizure and the body stiffened. The pt was treated with O2 (oxygen). The seizure resolved and the pt's color returned to normal. The pt was admitted to the hospital and was changed to another unspecified antibiotic. It was reported that the medical charts stated a working dx of sepsis, seizure and febrile illness. On 9/20/01, the pt remained hospitalized. This was originally reported by a pharmacist. No further information is available. F/U states: Information from a pharmacist indicated that the pt recovered and was discharged from the hospital on 9/26/01. The pharmacist indicated that the pt's serious adverse events were considered life-threatening. Further information has been requested. F/U states: the pt was admitted to the hospital on 9/19/01.
Age: 0.2
Sex: F
Vaccine: HBHEPB, IPV, HBHEPB, IPV
Symptoms: Heart rate increased, Musculoskeletal stiffness, Pallor, Platelet count increased, Pyrexia
Clinical narrative: This report is concerning a 9 week old female pt who on 9/19/01 was vaccinated with a dose of haemophilus b conjugate vaccine (+) hepatitis b vaccine recombinant (yeast). Secondary suspect therapy included an IV 160mg per 1 dose of ceftriaxone sodium (Rocephin), a dose of poliovirus vaccine. On 9/19/01, in the morning, post vax, the pt returned home from the pediatrician and vomited. At approx. 16:50, the pt was taken to the ER. She had a fever of 102.6F; pulse was 178 and respirations were 40. It was reported that sepsis was to be ruled out. At approx. 21:00, the pt commenced ceftriaxone sodium (Rocephin) 160mg IV reconstituted with 1 ml of dextrose (D5W) placed into a 500cc bag of dextrose (+) sodium chloride (D5 & 1/3NS) for 1 dose. This was administered through a Soluset. 5 minutes following the administration of Rocephin, the pt turned gray and was relocated to the resuscitation table. The pt went into a generalized tonic seizure and the body stiffened. The pt was treated with O2 (oxygen). The seizure resolved and the pt's color returned to normal. The pt was admitted to the hospital and was changed to another unspecified antibiotic. It was reported that the medical charts stated a working dx of sepsis, seizure and febrile illness. On 9/20/01, the pt remained hospitalized. This was originally reported by a pharmacist. No further information is available. F/U states: Information from a pharmacist indicated that the pt recovered and was discharged from the hospital on 9/26/01. The pharmacist indicated that the pt's serious adverse events were considered life-threatening. Further information has been requested. F/U states: the pt was admitted to the hospital on 9/19/01.
Age: 0.2
Sex: F
Vaccine: HBHEPB, IPV, HBHEPB, IPV
Symptoms: Respiratory rate increased, Sepsis, Vomiting
Clinical narrative: This report is concerning a 9 week old female pt who on 9/19/01 was vaccinated with a dose of haemophilus b conjugate vaccine (+) hepatitis b vaccine recombinant (yeast). Secondary suspect therapy included an IV 160mg per 1 dose of ceftriaxone sodium (Rocephin), a dose of poliovirus vaccine. On 9/19/01, in the morning, post vax, the pt returned home from the pediatrician and vomited. At approx. 16:50, the pt was taken to the ER. She had a fever of 102.6F; pulse was 178 and respirations were 40. It was reported that sepsis was to be ruled out. At approx. 21:00, the pt commenced ceftriaxone sodium (Rocephin) 160mg IV reconstituted with 1 ml of dextrose (D5W) placed into a 500cc bag of dextrose (+) sodium chloride (D5 & 1/3NS) for 1 dose. This was administered through a Soluset. 5 minutes following the administration of Rocephin, the pt turned gray and was relocated to the resuscitation table. The pt went into a generalized tonic seizure and the body stiffened. The pt was treated with O2 (oxygen). The seizure resolved and the pt's color returned to normal. The pt was admitted to the hospital and was changed to another unspecified antibiotic. It was reported that the medical charts stated a working dx of sepsis, seizure and febrile illness. On 9/20/01, the pt remained hospitalized. This was originally reported by a pharmacist. No further information is available. F/U states: Information from a pharmacist indicated that the pt recovered and was discharged from the hospital on 9/26/01. The pharmacist indicated that the pt's serious adverse events were considered life-threatening. Further information has been requested. F/U states: the pt was admitted to the hospital on 9/19/01.
Age: 0.2
Sex: F
Vaccine: HBHEPB, IPV, HBHEPB, IPV
Symptoms: Convulsion, Hyperventilation, Hypoxia, Pallor, Pyrexia
Clinical narrative: This report is concerning a 9 week old female pt who on 9/19/01 was vaccinated with a dose of haemophilus b conjugate vaccine (+) hepatitis b vaccine recombinant (yeast). Secondary suspect therapy included an IV 160mg per 1 dose of ceftriaxone sodium (Rocephin), a dose of poliovirus vaccine. On 9/19/01, in the morning, post vax, the pt returned home from the pediatrician and vomited. At approx. 16:50, the pt was taken to the ER. She had a fever of 102.6F; pulse was 178 and respirations were 40. It was reported that sepsis was to be ruled out. At approx. 21:00, the pt commenced ceftriaxone sodium (Rocephin) 160mg IV reconstituted with 1 ml of dextrose (D5W) placed into a 500cc bag of dextrose (+) sodium chloride (D5 & 1/3NS) for 1 dose. This was administered through a Soluset. 5 minutes following the administration of Rocephin, the pt turned gray and was relocated to the resuscitation table. The pt went into a generalized tonic seizure and the body stiffened. The pt was treated with O2 (oxygen). The seizure resolved and the pt's color returned to normal. The pt was admitted to the hospital and was changed to another unspecified antibiotic. It was reported that the medical charts stated a working dx of sepsis, seizure and febrile illness. On 9/20/01, the pt remained hospitalized. This was originally reported by a pharmacist. No further information is available. F/U states: Information from a pharmacist indicated that the pt recovered and was discharged from the hospital on 9/26/01. The pharmacist indicated that the pt's serious adverse events were considered life-threatening. Further information has been requested. F/U states: the pt was admitted to the hospital on 9/19/01.
Age: 0.2
Sex: F
Vaccine: HBHEPB, IPV, HBHEPB, IPV
Symptoms: Sepsis, Strabismus, Vomiting
Clinical narrative: This report is concerning a 9 week old female pt who on 9/19/01 was vaccinated with a dose of haemophilus b conjugate vaccine (+) hepatitis b vaccine recombinant (yeast). Secondary suspect therapy included an IV 160mg per 1 dose of ceftriaxone sodium (Rocephin), a dose of poliovirus vaccine. On 9/19/01, in the morning, post vax, the pt returned home from the pediatrician and vomited. At approx. 16:50, the pt was taken to the ER. She had a fever of 102.6F; pulse was 178 and respirations were 40. It was reported that sepsis was to be ruled out. At approx. 21:00, the pt commenced ceftriaxone sodium (Rocephin) 160mg IV reconstituted with 1 ml of dextrose (D5W) placed into a 500cc bag of dextrose (+) sodium chloride (D5 & 1/3NS) for 1 dose. This was administered through a Soluset. 5 minutes following the administration of Rocephin, the pt turned gray and was relocated to the resuscitation table. The pt went into a generalized tonic seizure and the body stiffened. The pt was treated with O2 (oxygen). The seizure resolved and the pt's color returned to normal. The pt was admitted to the hospital and was changed to another unspecified antibiotic. It was reported that the medical charts stated a working dx of sepsis, seizure and febrile illness. On 9/20/01, the pt remained hospitalized. This was originally reported by a pharmacist. No further information is available. F/U states: Information from a pharmacist indicated that the pt recovered and was discharged from the hospital on 9/26/01. The pharmacist indicated that the pt's serious adverse events were considered life-threatening. Further information has been requested. F/U states: the pt was admitted to the hospital on 9/19/01.
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Antisocial behaviour, Apathy, Aphasia, Neurodevelopmental disorder, Vaccination complication
Clinical narrative: Information has been received from a legal firm concerning an 18 month old male who on 10/22/99 was vaccinated with a dose of haemophilus b conjugate vaccine (lot 627558/0725H). The child is alleged to have suffered "devastating injuries through mercury toxicity and associated complications and sequelae and the aggravation of other conditions directly through exposure, via an IM injection of mercury". It was reported that the child has been in the care and custody of his parents since birth. He was born "perfectly normal" and healthy, with an Apgar score "well within the normal range". Developmentally, neurologically and socially, the child was reported to have achieved every developmental milestone anticipated of all normally developing children. These milestones included: by 3 months of age, he was alert, cooing, responding to sounds, responding to others and beginning to recognize and interact with his parents; at 6 months of age, he made speech sounds that form parts of words and was behavior responsive to his environment, his parents, other children and toys; at 18 months of age, he used 3 words strung together in a sentence-type form and had a vocabulary of approx. 25 words. It was reported that at approx. 18 months of age, he was "neurologically devastated by the accumulation of Mercury in his body, having been exposed via IM vaccinations and suddenly regressed developmentally, losing milestones of neurological development previously achieved". It was reported that the pt became withdrawn, unable to speak and unresponsive to his environment. He had a loss of language skills, motor skills and affect. It was also reported that the child received the following vaccinations, along with haemophilus b conjugate vaccine, "that contained the Mercury preservative Thimerosal": on 6/26/97 (lot 441103), 8/26/97 (lot 440-746) and 10/27/97 (lot 440-745), a dose (each date) of Engerix-B; on 8/19/98 (lot 362A2), a dose of Infanrix. The child was vaccinated "in compliance with the then prevailing vaccine schedule". It was alleged that the concomitant and aggregated injections of these vaccines has exposed him to mercury "in excess of all known Federal safe limits" and that the total exposure rate, at the time of report, was 187.5mcg. Upon internal review, mercury toxicity of 187.5mcg, developmental regression/loss of milestones, "unable to speak"/loss of language skills and loss of motor skills were determined to be "Other Important Medical Events". No further information is available.
Age: 0.4
Sex: F
Vaccine: HBHEPB
Symptoms: Abscess, Dyspnoea
Clinical narrative: Information has been received from a consumer concerning her approx. 22 week old daughter who on 6/6/00, 8/28/00 and 8/30/01 was vaccinated with the 1st, 2nd and 3rd doses of haemophilus b conjugate vaccine, hepatitis b vaccine recombinant (yeast), respectively. Concomitant therapy included 1 dose of MMRII, 1 dose of diphtheria toxoid/pertussis vaccine/teta and 1 dose of poliovirus vaccine. Following the 2nd dose, the pt developed an abscess and "later on" some breathing problems. She "later" developed an abscess on her leg. Following the 3rd dose, she developed another abscess. It was reported that all of the abscesses were lanced and she was on antibiotics "for a long time". It was also reported that her lungs were normal. The pt sought unspecified medical attention. Upon internal review, abscess and "breathing problems" were determined to be "Other Important Medical Events". Additional information has been requested. A 15-day follow up report received 11/16/2001 adds: Follow-up info was received from a nurse on 10/24/2001. She indicated that it seemed the child's mother had taken her for many tests. It was reported that the child was seen most recently in the physician's office on 10/11/2001, with a right buttock abscess. Follow-up info was received on 10/26/2001 from a physician which indicated that the pt had a history of recurrent bronchiolitis, which was why "breathing problems" and a lung biopsy were mentioned in a previous report. It was reported that these issues occurred prior to vaccination with haemophilus b conjugate vaccine (+) hepatitis b vaccine recombinant (yeast). It was also noted that due to the pt's history of bronchiolitis, the pt pt had an immunologic workup, which was negative. It was reported that after each vaccination with haemophilus b conjugate vaccine(+) hepatitis b vaccine recombinant (yeast), the pt developed an abscess in her thigh at the injection site. The physician reported that the pt's last dose of haemophilus b conjugate vaccine (+) hepatitis b vaccine recombinant (yeast) was administered in the right thigh (also reported as the left buttock) in August 2001. Approximately 20 days post vaccination, the pt developed an abscess in her right thigh, which was lanced and she was treated with unspecified antibiotics. It was noted that the pt was currently doing "well". Upon internal review, abscess was determined to be an other important medical event. Additional info has been requested.
Age: 0.5
Sex: M
Vaccine: DTPHIB, HEP
Symptoms: Aphasia, Coma, Nervous system disorder, Neurodevelopmental disorder, Vaccination complication
Clinical narrative: The child received his 1st injection of Engerix-B (lot ENG22439) on 5/29/97, at 1 month of age and his 2nd injection of Engerix-B (lot ENG229729) on 10/27/97, at 6 months of age. Other vaccines reportedly administered included combination diphtheria and tetanus toxoids and pertussis vaccine adsorbed and haemophilus influenza type b conjugate vaccine (Tetramune) on 6.26/97 and 10/27/97, diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, lot 362AZ, see report 2001025030-2) on 8/19/98 and haemophilus influenza type b conjugate vaccine (MSD) on 10/22/99. The child's lawyer stated, "The concomitant and aggregated injections of vaccines has exposed him to mercury in excess of all known Federal safe limits. The total exposure to date, exceeds 187.5mcg." The child's attorney alleged that "At approx. 18 months of age, (the child) was neurologically devastated by the accumulation of Mercury in his body, having been exposed via IM vaccinations and suddenly regressed developmentally, losing milestones of neurological development previously achieved, specifically including, but not limited to, the following: a. He became withdrawn, unable to speak, unresponsive to his environment; and b. His injuries include the loss of language skills, motor skills and affect." The attorney alleged that the child "sustained severe devastating permanent neurological injuries." The lot numbers provided for Engerix-B and Infanrix are not valid lot numbers.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Dyspnoea, Hypoxia
Clinical narrative: Approx. 5 minutes, post vax, infant started irregular "gasping" respirations. O2 sats decreased to low 80's for 1 minute then recovered to 96-99. Breathing slowly reoccurred to normal over 15-20 minutes. Admitted for observation to hospital. No rashes or fevers. Lungs clear.
Age: 5.0
Sex: M
Vaccine: DTPHIB, MMR
Symptoms: Autism, Pyrexia, Rash morbilliform
Clinical narrative: Pt developed a temperature of 105F with Morbilliform rash, 8 to 9 days, post vax. He has Autism.
Age: 2.0
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: 30 hours, post vax, pt's right thigh had redness, swelling and warmth. The whole thigh was red and swollen; redness down past knee. His fever was 106.6 (oral).
Age: 0.8
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Injection site erythema, Injection site induration, Urticaria
Clinical narrative: The pt developed generalized urticaria, including significant erythema and induration to the right thigh. This was second injection of all 5 vaccines. The pt felt most likely due to Prevnar, no respiratory distress. the pt was treated with Benadryl.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site erythema, Injection site mass, Irritability
Clinical narrative: The pt experienced a 2 cm tender nodule at the injection site approximately 24 hours post vax with increased irritability, no fever, no itching, was noted. The pt also experienced erythema to the right upper leg. Treated with cephalexin.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Agitation
Clinical narrative: The pt experienced inconsolable crying in the early morning of 10/4/01.
Age: 7.0
Sex: F
Vaccine: HEPA, PNC
Symptoms: Injection site erythema
Clinical narrative: The pt experienced a local reaction to the right deltoid with redness / erythema and warmth. Treated with Benadryl and ice pack.
Age: 1.0
Sex: M
Vaccine: MMR, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: The pt experienced a fever of 104 and a seizure.
Age: 0.75
Sex: M
Vaccine: PPV
Symptoms: Anaphylactic reaction, Angioneurotic oedema, Respiratory distress, Urticaria
Clinical narrative: Pt was seen for well child exam 09/28/2001 at 10:30 am. Mother f/u with me on 10/01/2001 and related that Gustano developed that same afternoon about 4 pm, respiratory distress, angioedema, of the lips and face and an urticaual skin rxn. Pt was treated and released from the hospital, for an anaphylactic reaction to unknown trigger. Continue oral course of Benadryl and Epi-Pen JR. ER states non reactive to vaccine. Has an upcoming appointment with Allergist 10/24/2001 for further testing to determine hypersensitivity trigger.
Age: 0.39
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Erythema, Rash, Rash maculo-papular
Clinical narrative: Within seconds of last shot. Legs become red. Red splotches noted over both lower extremities, is seen by Dr. Four dime size spot on forehead. One dime size spot on mid chest. After eight minutes, rash was almost completely resolved.
Age: 1.0
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Chick pox rash 2 weeks following Varivax.
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Injection site reaction
Clinical narrative: Severe local reaction on 10 cm Drdenta.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: On 10/12 at 9 pm, presented to IC nurse who gave immunization. Rash over entire body, sent to Clinic, was put on Benadryl. States woke up with rash in morning, also had pied for sipper the night before? of reaction from olsu. Rash gone in a few days.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Hypersensitivity, Pruritus, Urticaria
Clinical narrative: Day after receiving vaccine, lip was swollen- 2 days later had hives on legs, 4 days later hives on arm, upper back with itching.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Received call on 10/18/2001 regarding a reaction at site. The injection was given 10/16/2001, client complained of warmth at site, redness and tenderness as well as a bump. Area of redness is about the size of a half dollar. Called 10/19/2001 following heat, swelling is down, redness abating and less tender.
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea
Clinical narrative: Onset of diarrhea after injection. (with 24 hr) Still having same discomfort so question if really related
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Injection site oedema, Vasodilation procedure
Clinical narrative: Both arms, above elbows red, swollen, joints ache, red streak inside right arm by elbow. Upper arms warm to touch.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Depression, Hypothyroidism, Myasthenic syndrome, Pain
Clinical narrative: After receiving flu vaccine, pt felt deep ache and weakness down left arm. Injection given October 11, 2001 in left deltoid. Pt taking large amounts of Tylenol.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Pneumococcal vaccine RD-SQ 10/15/2001. Complained of Redness at site. High fever 103 degrees. Tx Tylenol, cool compress. Referred to family practice.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site oedema
Clinical narrative: Small bump at injection site right arm at time of injection of flu vaccine (IM).
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Face oedema, Rash, Urticaria
Clinical narrative: After receiving flu shot, went home and went to sleep. Approximately seven hours later, awoke with rash around waist that progressed to hives all over body and swollen eyelids. No shortness of breath. Missed two days of work. Saw private MD and put on Atarax and Benadryl.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Diabetes mellitus, Erythema, Injection site oedema, Vasodilatation
Clinical narrative: Three quarters to one inch diameter lump at injection site. Raised and hot to touch with erythma. Benedryl 25mg po given. Ice applied to affected area for 15 minutes.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Pain, Pyrexia
Clinical narrative: Low grade fever, very achy. Left arm at injection site red and swollen approximately 2 inches by 2 inches.
Sex: U
Vaccine: FLU3
Symptoms: Asthenia, Bradycardia, Hypotension, Hypoventilation
Clinical narrative: Bradycardia, drug induced hypotension, weakness and respiratory depression.
Age: 15.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia
Clinical narrative: 15 year old with knee pain, received Lyme disease vaccine recombinant OSpA (LYMErix). Knee pain on and off since 08/24/2001, the medical history, concurrent illnesses, and concurrent medications were not specified.
Age: 5.0
Sex: M
Vaccine: DT
Symptoms: Erythema
Clinical narrative: Redenned area to left arm. Prescribed Atarax.
Age: 0.4
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Redness and swelling over area of shot and 10 days later has 1 cm knot.
Age: 1.0
Sex: M
Vaccine: DTPIPV, HBHEPB
Symptoms: Gait disturbance, Injection site inflammation, Joint range of motion decreased, Laboratory test abnormal, Pain
Clinical narrative: Leg pain, evening after vaccination given, a limp secondary to hip inflammation and decrease ROM. Not yet recovered, will be following.
Age: 1.0
Sex: M
Vaccine: DTPIPV, HBHEPB
Symptoms: Red blood cell sedimentation rate increased, White blood cell count increased
Clinical narrative: Leg pain, evening after vaccination given, a limp secondary to hip inflammation and decrease ROM. Not yet recovered, will be following.
Age: 5.0
Sex: F
Vaccine: DTAP, DTPIPV
Symptoms: Coma, Convulsion, Strabismus
Clinical narrative: Less than 24 hours later, pt developed pro doable seizure with eye deviation and unresponsiveness greater than.
Age: 66.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient recieved vaccination at 1300 hours, at 1900 hours had edema and erythema in area, took 50 mg Benadryl, at 1300 hours pt awoke with worsening edema and erythema up neck and down arm.
Age: 48.0
Sex: M
Vaccine: TD
Symptoms: Cellulitis, Injection site oedema, Injection site warmth, Pain, Pyrexia
Clinical narrative: Swelling at injection site, heat, tenderness, with low temperature, draining into lower arm (cellutitis), pt PMD, prescribed antibiotics and Benadryl site. Also blurring vision.
Age: 48.0
Sex: M
Vaccine: TD
Symptoms: Vision blurred
Clinical narrative: Swelling at injection site, heat, tenderness, with low temperature, draining into lower arm (cellutitis), pt PMD, prescribed antibiotics and Benadryl site. Also blurring vision.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Skin ulcer
Clinical narrative: Came to my office with vesicles and differing stages of lesions.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: On 10/5/2001, varicella vaccine. On 10/7/2001, exposed to active varicella. On 10/11/2001, varicella eruption.
Age: 1.0
Sex: M
Vaccine: DTAP, HBPV
Symptoms: Injection site induration
Clinical narrative: Parents brought child back into office within a half hour of immunization. Child had huge (6 cm in duration) on leg of HIB vaccine. Benadryl 12.5 po, ice pack, and Tylenol. Gave Benadryl through the night.
Age: 68.0
Sex: M
Vaccine: HEPA
Symptoms: Back pain, Chromaturia, Fatigue, Jaundice, Laboratory test abnormal
Clinical narrative: On 5/19/2001 began having fatigue and backache. On 5/23/2001 developed fever to 100.1 and dark urine. Symptoms resolved 24 hours after fever began. Peak bilirubin 3.4. Exam notable only for mild jaundice. Seen in office 5/24/2001 and asymptomatic. no alcohol.
Age: 68.0
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: On 5/19/2001 began having fatigue and backache. On 5/23/2001 developed fever to 100.1 and dark urine. Symptoms resolved 24 hours after fever began. Peak bilirubin 3.4. Exam notable only for mild jaundice. Seen in office 5/24/2001 and asymptomatic. no alcohol.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Nausea, Oedema
Clinical narrative: Redness, edema at injection site. Redness extended down arm where injection was given. Also had headache and nausea.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Pruritus
Clinical narrative: Edema and itching at site of injection, one day after administration. Ordered to take OTC Benadryl and APAP for discomfort and RTC for f/u with MD but pt never showed for f/u appointment.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Hypotension, Injection site erythema, Injection site pain, Pruritus
Clinical narrative: Pt received Varivax between 8:30am-4:30pm on 6/22/2001. Pt stated on 6/25 that she developed a red circle on arm on 6/22 pm and then soreness and pruritus 6/23 am. Pt took Allegra and then 6/24 Advil and Allegra. On 6/25 visit temp 97.3 BP 100/60 HR 67. Left outer upper arm with 9cm by 9cm are of erythema. Sent to hospital urgent care. Treatment:Reflex 500mg TID. Follow up on 6/29 stated pt felt better.
Age: 24.0
Sex: F
Vaccine: RUB
Symptoms: Laboratory test abnormal
Clinical narrative: No adverse event. Pt called 7/24/2000 stating she was pregnant. Pt had a baby 4/01 with no defects.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Feeling hot, Injection site erythema, Injection site oedema, Injection site swelling
Clinical narrative: Pneumovax given 8/23/2001. Complained of swelling, itching, painful left arm on 8/24/2001, 10 by 10cm erythematous raised area, warm tender. Diagnosis possible early celluitis. Given ice packs, QiD for 24 hours then warm compress, hydroxyzine 25mg TiD, TMC cream, Keflex 500mgTID for 7 days.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pruritus
Clinical narrative: Pneumovax given 8/23/2001. Complained of swelling, itching, painful left arm on 8/24/2001, 10 by 10cm erythematous raised area, warm tender. Diagnosis possible early celluitis. Given ice packs, QiD for 24 hours then warm compress, hydroxyzine 25mg TiD, TMC cream, Keflex 500mgTID for 7 days.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Swelling, erythema, redness, pruritis at local area of injection. SOB (Left upper arm)
Age: 2.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blister, Herpes zoster, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Herpes Zoster T2 distribution - raised, painful, pruritic, confluent erythema, vesicles on right arm, right chest and right back along T2 distribution for 4 days.
Age: 2.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pruritus
Clinical narrative: Herpes Zoster T2 distribution - raised, painful, pruritic, confluent erythema, vesicles on right arm, right chest and right back along T2 distribution for 4 days.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Pruritus, Pyrexia
Clinical narrative: Pt developed varicella like lesions after having received vaccine 5 years before. She had temp of 103 at time. There was itching but no crusts.
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Hives within 24 hours of second Hep A vaccine.
Age: 3.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Broke out with chicken pox
Age: 1.75
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Arthropathy
Clinical narrative: After immunizations 10/04/2001, she began to throw her leg out when she walked, no knots no limp.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Cough, Rash maculo-papular, Rhinorrhoea
Clinical narrative: Red spots on his nose, a runny nose and cough reported by mom, starting a few days after shot, resolved spontaneously.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema
Clinical narrative: Edema, redness, swelling of arm, developing to cellulitis. Treated with cephalosporin antibiotic.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, MMR
Symptoms: Urticaria
Clinical narrative: Urticaria, treatment Benadryl.
Age: 1.0
Sex: F
Vaccine: DTAP, HEP, HIBV
Symptoms: Rash, Rash erythematous
Clinical narrative: Bumpy rash on face, chest and back area. At site of immunization is red-size of dime-looks black and blue around area. Benadryl and warm compresses.
Age: 30.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Myalgia, Pyrexia
Clinical narrative: Elevated temp (101 oral), muscle aches, headaches and lightheadedness.
Age: 4.9
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Day after immunizations, at site of injections have red, subsequently warm area. left thigh measures 5cm by 5cm. Prescribed Augmentin
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Rash
Clinical narrative: Administered DTAP, IPV and MMR given. Noticed while placing Bandaids on that left arm at site of MMR reddened. Pt complained of nothing being wrong except arms sore from injections. Also noticed few red areas on other arm and chest. Notified MD immediately. Benadryl 15mg given and Prelone ttsp po as ordered by MD.
Age: 85.0
Sex: M
Vaccine: PPV
Symptoms: Musculoskeletal stiffness, Myalgia, Oedema
Clinical narrative: Within 2 weeks of vaccination, pt developed muscle pain, swelling and stiffness.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Urticaria
Clinical narrative: Edema, erythema, induration and warmth in left arm lateral to medial bicep 8 in by 3.5 in an urticaria. Symptoms began evening on same day of injection. Treated with hydroxyzine 10mg 1-2 98h prn, TMC cream, ice packs then warm compresses prn.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Tremor
Clinical narrative: Tremors within 8 hors of shots. Tremors have continued daily since shots.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Developed atypical varicella.
Age: 7.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Convulsion, Eye movement disorder, Hyperhidrosis, Salivary hypersecretion, Tremor
Clinical narrative: On 10/15/2001, pt received MMR vaccine at 12 noon. Mother stated seizures started at approximately 8 pm and continued through the night. There were 5 seizures;each lasted 5-10 minutes long; pt arched back, eyes rolled back into head, spitting, shaking and sweating.
Age: 7.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Convulsion, Eye movement disorder, Neurodevelopmental disorder, Posturing
Clinical narrative: On 10/15/2001, pt received MMR vaccine at 12 noon. Mother stated seizures started at approximately 8 pm and continued through the night. There were 5 seizures;each lasted 5-10 minutes long; pt arched back, eyes rolled back into head, spitting, shaking and sweating.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Convulsion, Pyrexia
Clinical narrative: Five days after vaccine had focal seizure with fever. Had completely normal evaluation later that day
Sex: M
Vaccine: LYME
Symptoms: Anorexia, Flatulence, Influenza like illness, Pain, Weight decreased
Clinical narrative: Aches and pains in an "adult" male of unspecified age who received Lyme disease vaccine recombinant OspA (LYMErix). After receiving dose 3 of LYMErix, "two years ago", experienced flu-like symptoms, loss of appetite, weight loss of 10-12 pounds, and increase in gas. Reportedly, he has not seen a physician concerning these symptoms. As of 07/02/2001, the adverse events were reportedly unresolved.
Age: 36.0
Sex: M
Vaccine: DTAP
Symptoms: Arthralgia, Fatigue, Headache, Infection
Clinical narrative: Described Lyme disease in 36 year old male who reportedly received the complete immunization series of Lyme disease vaccine recombinant OspA (LYMErix). This report was received from the vaccine and has been verified by a physician or other healthcare professional. Medical history, concurrent conditions, and concurrent medications were not provided. The vaccinee work outdoors. The vaccinee stated that he received three injections of LYMErix, with the last dose in 05/2000. After 14 months of completing the LYMErix immunization series, the pt underwent a complete physical. he reported fatigue, headaches, and severe joint pain, especially in his feet and hands. The vaccinee requested to be tested for Lyme disease. He was notified by his physician that an unspecified test for Lyme disease was positive.
Age: 48.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Back pain, Bone pain, Fatigue, Hypokinesia
Clinical narrative: The pt received the first and second injections of Lymerix in September and October 1999, respectively. The pt had no adverse experiences following the receipt of these two injections. She received her third injection of Lymerix in November 2000. In November 2000, an unspecified time after receiving the third injection, the pt began to experience fatigue. In November 2000 or December 2000, she began to experience "muscle pain all over". In February 2001, she began to experience bone pain and could not move her right arm or her neck. She was seen by her physician who reportedly prescribed massage therapy; this was not effective. In March or April 2001 the pt began to experience stiffness in her left ankle, left knee and left elbow. She also experienced back pain that radiated to both legs, pain that "would travel from "joint to joint", and night sweats. Her symptoms persisted and she was seen by her physician on 07/03/2001. The pt reported that a diagnosis of Lyme disease was made and three weeks of unspecified antibiotics was prescribed. She reported that her symptoms persisted as of 07/16/2001.
Age: 48.0
Sex: F
Vaccine: LYME
Symptoms: Infection, Joint stiffness, Myalgia, Night sweats
Clinical narrative: The pt received the first and second injections of Lymerix in September and October 1999, respectively. The pt had no adverse experiences following the receipt of these two injections. She received her third injection of Lymerix in November 2000. In November 2000, an unspecified time after receiving the third injection, the pt began to experience fatigue. In November 2000 or December 2000, she began to experience "muscle pain all over". In February 2001, she began to experience bone pain and could not move her right arm or her neck. She was seen by her physician who reportedly prescribed massage therapy; this was not effective. In March or April 2001 the pt began to experience stiffness in her left ankle, left knee and left elbow. She also experienced back pain that radiated to both legs, pain that "would travel from "joint to joint", and night sweats. Her symptoms persisted and she was seen by her physician on 07/03/2001. The pt reported that a diagnosis of Lyme disease was made and three weeks of unspecified antibiotics was prescribed. She reported that her symptoms persisted as of 07/16/2001.
Sex: F
Vaccine: LYME
Symptoms: Erythema
Clinical narrative: Report 20010185421 described skin turning red (hands and arms) in a female pt of unspecified age who received Lymerix. In 1999 and 2000 the pt received the first, second and third doses of Lymerix. Subsequent to receiving the third dose, the pt felt that her hands and arms were getting redder. Th pt thought that this adverse event was possibly related to Lymerix. As of July 30,2001, the outcome of the event was unknown.