chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain, Injection site reaction, Pyrexia
Clinical narrative: On 3/26/03 PT had 4 yrs old WCC (white cell count). On 3/28/03, presented with swelling and redness in right arm. Had temp of 100 oral and c/o pain right arm. Given Rx for augmentin ES pusp, 600 mg, and ESP PO BID x 10 days.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Oedema
Clinical narrative: Swollen (arm) left upper arm
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain, Vasodilation procedure
Clinical narrative: Left arm hot / swollen / erythema / tender to touch. No fever.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Right thigh cellulitis which required hospitalization and IV autiriotic therapy for recovery.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site hypersensitivity, Injection site mass, Injection site pain, Injection site reaction
Clinical narrative: Right deltoid area erythematous (5 x 5 cm) w/area of induration, tender to palpation and warm to palpation. Dx: Cellulitis us reaction Tx: Cephalexin QID x 5 days.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Vasodilation procedure
Clinical narrative: Right deltoid area erythematous (5 x 5 cm) w/area of induration, tender to palpation and warm to palpation. Dx: Cellulitis us reaction Tx: Cephalexin QID x 5 days.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: Erythema and edema of right deltoid area w/mild edema approx 2 cm x 1 cm, not tender.
Age: 73.0
Sex: F
Vaccine: TD
Symptoms: Hypokinesia, Injection site reaction
Clinical narrative: Client states that her right arm and shoulder have been affected and has some loss of mobility. Client called the reporting facility wanting the lot # of the Td vax site was given. She did not want to give any info regarding her condition.
Age: 2.0
Sex: F
Vaccine: PNC
Symptoms: Erythema, Oedema, Pain
Clinical narrative: C/O pain, swelling et redness. Tx with Motrin, ice.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Folliculitis, Rash, Vaccination complication
Clinical narrative: Normal variant-satellite lesions around vaccine site likely-cultures pending. Back lesions c/w pass diss varicella vx folliculitis gotyp em biopsy P pt well.
Age: 2.5
Sex: M
Vaccine: DTAPH, IPV, PNC
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Pt's mom notified Dr. at ofc. visit 1 wk. after getting injection that his leg had become red and swollen after vaccine. Mom says red and swollen area was approx 2-3" diameter on his Rt. thigh. Mom gave Benadryl. Area went away post several days.
Age: 3.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site mass, Rash maculo-papular
Clinical narrative: Two wks post vaccination, father of child calls to report redness and lump at injection site. Says earlier she had a maculopapular rash on back. Appears fine otherwise, according to father. Rash lasted "couple of days."
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site warmth, Rash maculo-papular
Clinical narrative: Left anterior thigh with red splotchiness surrounding immunization site, slightly warm, no induration. Symptomatic treatment only.
Age: 5.0
Sex: M
Vaccine: DTAPH, IPV, MMR
Symptoms: Injection site induration
Clinical narrative: Large circular induration on left arm at injection site. Symptomatic treatment only.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 4"x4" erythematous indurated area on left deltoid no flucturance appreciated. Symptomatic treatment.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: Pt received injection at 8:45am on 4/2/03, did not mention any rxn to MD when seen at 10:50am, pt went to another medical facility on 4/3/03, complaining of rxn to injection site, redness, swelling, and pain at site.
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Diarrhoea, Urticaria
Clinical narrative: Diarrhea approx. 3 hrs after immunization. On 4/8/03 approx. 10am developed hives. Denied shortness of breath of fever. Afternoon of 4/8/03 all symptoms resolved.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Pt received DTaP in left thigh on 3/21/03. Came in on 3/24/03 with c/o swollen L thigh where had vaccine. Tender to touch; red.
Age: 0.7
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Decreased appetite, Pyrexia
Clinical narrative: Developed fever on day of vaccination to 102 degrees-not responding to Tylenol or Motrin; decreased appetite. Drinks little. Family speaks Creole-some problems with communication.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Red swollen L arm-reported by clinic seen by physician and started on antibiotics 3/28/03-no diagnosis.
Age: 1.5
Sex: F
Vaccine: DTAP, HBHEPB, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Reported by clinic nurse child had red, swollen L leg. Started on antibiotic therapy 3/28/03-no diagnosis.
Age: 1.2
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Face oedema, Urticaria
Clinical narrative: Child received vaccines DTaP, varicella at approx 7pm at 8:30 presented in office with welts to body: swelling over face no hx of allergies.
Age: 1.3
Sex: M
Vaccine: DTAP, HBHEPB
Symptoms: Dry skin, Erythema, Pruritus, Rash
Clinical narrative: Pt hospital immunization clinic. Approx 30 min after receiving DTaP #4, Comvax #2. Child present with patchy red, itchy rash on nose, ears, neck, upper back. No respiratory distress. Skin warm and dry. Sent to hospital ER.
Age: 1.08
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: 13 month old female with a history of low grade fever to 100.7 associated with redness at injection site right anterior thigh.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site mass, Swelling, Tenderness
Clinical narrative: Left leg swollen from knee up. Red and tender to touch. Began in the evening after injection 4/8/03. Patient returned to clinic 4/9/03 in morning. Treated with ice pack and ibuprofen. Follow up appointment with provider again 4/10/03. Patient had had red lump at injection site after each DTaP.
Age: 14.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Pruritus, Rash
Clinical narrative: Student reported to health office during school day with c/o red, raised pin sized rash over abdomen and neck area. Itching. Started 1-2 days ago.
Age: 19.0
Sex: F
Vaccine: ANTH
Symptoms: Anaphylactic reaction, Injection site urticaria, Paraesthesia, Urticaria
Clinical narrative: HIVES AT INJECTION SITE.  HIVES SPREAD TO CHEST, NECK, AND FACE WITHIN 5 MINUTES.  PT C/O TINGLING IN HANDS AND FEET.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Cough, Pallor, Pneumonia, Pyrexia, Wheezing
Clinical narrative: Patient came to HD for MMR with Dad. Patient had slight cough but no fever or other symptoms.  later in AM, patient was transported to Hospital per squad for fever, wheezing, paleness.  Seen in ER and admitted for pneumonia.  In talking to ICP at hospital, child had been sick but dad gave tylenol before coming to health dept. for immunization.  ICP stated that medcial record stated the MMR was incidental.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Headache, Malaise, Rash maculo-papular, Rash pustular
Clinical narrative: On day 11 following SV (PV) developed headache and macular-papular rash on upper trunk, chest, upper extremities, side and back that is now forming 3-5 pustules. Seen today Dx-Non Viral Pustulasis. Rx with increased dose Allegra for itching.  Rash, headache, malaise day 11 following SP vaccination. Primary vaccine who presents c/o erythermatous, non pruritic scattered rash on his torso. Pt received SP vaccine on his left upper arm on 21 Feb 03 seperate from any other vaccine. He also reports 1-2 days of "flu like symptoms" headache and  malaise.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Diarrhoea, Injection site erythema, Injection site oedema, Lymphadenopathy, Pyrexia
Clinical narrative: Seamen received SP and anthrax vaccine # 1 02/23/2002. He is a primary vaccine. On day ? c/o red, swollen left arm. increased lymph nodes, increased temp (102) diarrhea. Rx with anti-inflammatory.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Lymphadenopathy
Clinical narrative: Service member recieved SP vaccine(3 pricked, anthrax #1 and PPD 02/25/2003). On 02/27/2003 he received 2nd SP vaccine (15 pricks). He had no c/o SOB, chest pain , nausea, vomiting, fever, headache, or rashes. Also no reported swelling art site , increased lymph nodes.
Age: 31.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site induration, Swelling, Tenderness
Clinical narrative: Major RX- induration 30 mm erythema 21 mm with painful swollen RUE, and enopathy - exqusitery tender possible celluitis
Age: 42.0
Sex: M
Vaccine: SMALL
Symptoms: Lymphadenopathy, Myalgia, Pain, Pyrexia, Sleep disorder
Clinical narrative: Developed elevated temperature with muscle aches and pains Day 7 after vaccination.  Swollen, painful lymph notes, unable to sleep x 24 hours.  Missed one day of work
Age: 32.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Lymphadenopathy, Pain
Clinical narrative: Major local RX- severe pain with induration of 35mm. erythema 15 mm with streaking and adenopathy, No NODES palpable 0 temp. nausea
Age: 47.0
Sex: F
Vaccine: SMALL
Symptoms: Abdominal pain, Asthenia, Dyspnoea, Nausea, Paraesthesia
Clinical narrative: 3/25/03 - sudden abdominal pain, SOB, weakness, nausea, tingling of arms and hands.  Went to Hospital er, EKG, chest x-ray, nitroglycerine, ASA, QIcectail, O2 per nasal canal, Bloodwork and sent home 3/27/03
Age: 51.0
Sex: F
Vaccine: SMALL
Symptoms: Chest pain, Pain
Clinical narrative: Chest pressure with pain lasting 203 minutes on day 3 (3-20-03). ongoing laeft arm ache on 3-21-03.
Age: 29.0
Sex: M
Vaccine: SMALL
Symptoms: Back pain, Chills, Cough, Injection site erythema, Malaise
Clinical narrative: Vaccinated 3/25/03.  Started feeling poorly on 4/2/03.  Felt warm with neck and shoulder pain.  On Tuesday, 4/3/03 began to feel worse with both sides of neck and Left shoulder pain, lower back pain.  By evening, had fever 103 degrees Farenheit, chills.  Area around vaccination and beyond reddened.  On 4/4, area of redness increased.  Still with neck and shouldler pain.  Seen at Health Department.  B/P 110/70, Pulse 92, respirations 20, Temperature (oral) 100.6.  Examined by Dr.  Keflex 250mg po QID x3 days ordered.  Appointment made to see patient on 4/6/03.  Per Dr., patient with dry cough.  Vaccination site no worse.  Patient feeling somewhat better.  Another four days of Keflex ordered.
Age: 29.0
Sex: M
Vaccine: SMALL
Symptoms: Neck pain, Pyrexia, Shoulder pain
Clinical narrative: Vaccinated 3/25/03.  Started feeling poorly on 4/2/03.  Felt warm with neck and shoulder pain.  On Tuesday, 4/3/03 began to feel worse with both sides of neck and Left shoulder pain, lower back pain.  By evening, had fever 103 degrees Farenheit, chills.  Area around vaccination and beyond reddened.  On 4/4, area of redness increased.  Still with neck and shouldler pain.  Seen at Health Department.  B/P 110/70, Pulse 92, respirations 20, Temperature (oral) 100.6.  Examined by Dr.  Keflex 250mg po QID x3 days ordered.  Appointment made to see patient on 4/6/03.  Per Dr., patient with dry cough.  Vaccination site no worse.  Patient feeling somewhat better.  Another four days of Keflex ordered.
Age: 56.0
Sex: F
Vaccine: SMALL
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site vesicles, Lymphadenopathy
Clinical narrative: Celluitis with 50 mm induration, 30mm erythema and 10 mm vesicle with pain and lymph adenopathy
Age: 45.0
Sex: F
Vaccine: SMALL
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site swelling, Lymphadenopathy
Clinical narrative: Severe local reaction 40mm X 25mm induration with erythema swollen tender anterior auxillary nodes - celluitis.
Age: 30.0
Sex: M
Vaccine: SMALL
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Feeling hot
Clinical narrative: vaccination site was left deltoid. On the left shoulder across the back to the right shoulder was a small papular rash.  there was a small pustular lesion on the right anterior chest and on the right wrist. Vaccinated on 3-21-03 at HD. Take recorded on 3-27-03(vaccination lesion now scabbed over).  He then went to hospital where his father had been hospitalized and a rash was noticed (described as pimple on the back).  Called Health Dept. and was referred, who referred him to Dr. Dr. reportedly told him that he had not spread the virus to his back; also told him that he should avoid contact with other persons for a period of time to reduce any possible chance of transmitting vaccinia to tohers; gave him some type od anti-pruritic medication.  Approx. 3-4 days ago, developed diarrhea, which lasted 2 days. Yesterday he was tired, aching, sweaty, joint discomfort, felt hot at times (did not take his temp) possibly some nausea.  Denied vomiting or diarrhea.  Today still not feeling well with simialr symptoms, including apparent chilling. States he has had headache at times during past 2 weeks, which he attributes to sinuses.  It does not seem to be particularly bothersome.  Says the rash has kind of gone away.  It is less noticable than previously.  No areas of noticable erythema.  Told him it was possible his recent symptoms were due to a viral infection and might not be related to his vaccination. Recommended that he call his private physician's office, describe what he is experiencing and see if they want to evaluate him and see if they could see him.  Gave him my home phone number is case his physician had further questions.
Age: 30.0
Sex: M
Vaccine: SMALL
Symptoms: Hyperhidrosis, Nausea, Pain, Rash papular, Skin ulcer
Clinical narrative: vaccination site was left deltoid. On the left shoulder across the back to the right shoulder was a small papular rash.  there was a small pustular lesion on the right anterior chest and on the right wrist. Vaccinated on 3-21-03 at HD. Take recorded on 3-27-03(vaccination lesion now scabbed over).  He then went to hospital where his father had been hospitalized and a rash was noticed (described as pimple on the back).  Called Health Dept. and was referred, who referred him to Dr. Dr. reportedly told him that he had not spread the virus to his back; also told him that he should avoid contact with other persons for a period of time to reduce any possible chance of transmitting vaccinia to tohers; gave him some type od anti-pruritic medication.  Approx. 3-4 days ago, developed diarrhea, which lasted 2 days. Yesterday he was tired, aching, sweaty, joint discomfort, felt hot at times (did not take his temp) possibly some nausea.  Denied vomiting or diarrhea.  Today still not feeling well with simialr symptoms, including apparent chilling. States he has had headache at times during past 2 weeks, which he attributes to sinuses.  It does not seem to be particularly bothersome.  Says the rash has kind of gone away.  It is less noticable than previously.  No areas of noticable erythema.  Told him it was possible his recent symptoms were due to a viral infection and might not be related to his vaccination. Recommended that he call his private physician's office, describe what he is experiencing and see if they want to evaluate him and see if they could see him.  Gave him my home phone number is case his physician had further questions.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: CHILD PRESENTED TO CLINIC ON 4/10/03 WITH LEFT UPPER ARM ERYTHEMA MEASURING 15CM X 8CM, MILDLY INDURATED, NO PUS
Age: 27.0
Sex: F
Vaccine: SMALL
Symptoms: Chest pain, Lymphadenopathy, Oedema
Clinical narrative: 27 yr. old female.  Pain in upper chest. Lump in upper left chest as well as swollen and tender lymph glands in left shoulder.  Seen by infectious disease physician, on 3-25-2003, Day 8 post vaccination. No time lost from work. No treatment.
Age: 34.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Injection site pain, Lymphadenopathy
Clinical narrative: On 03-20-03, day 7 post-vaccination, this primary vaccinee was noted to have several open skin tears and erythema surrounding the vaccination site with swelling of the arm distal from the vaccination site to slightly above the elbow.  Also reported swollen lymph nodes in the left axilla.  Vaccinee was advised to discontinue use of the semipermeable dressing and use gauze dressing until skin tears healed.  On day 8, reported use of hypoallergenic semipermeable dressing with decrease in erythema.  On 03-23-03, day 10 post-vaccination, vaccinee presented to local ER due to complaint of pain, intense itching, increased redness and swelling surrounding the vaccination site.  Vaccinee also reported sore mouth and throat described as feeling like ulcers.  Medical records indicate vaccinee was afrebrile with normal CBC; physical exam was reported significant for left axillary adenopathy, with a tender, swollen, reddened "band" with mild calor surrounding the vaccination site and encircling the left upper arm.  Diagnosis was recorded as "variant reaction to smallpox vaccination" with discharge home with prescription for Vicodin as needed for pain.  Assessment on day 14 post-vaccination revealed decrease in swelling and redness surrounding the site, lymph nodes in left axilla remained swollen but decrease in tenderness was reported.  Two new skin tears noted due to use of paper tape, previous skin tears healing.  Vaccinee reported now using gauze secured with "Kerlix type" wrap. By day 18 post-vaccination, swelling of arm and lymph nodes had resolved,  reported systemic symptoms resolved, minimal erythema noted surrounding the vaccination site, skin tears almost healed; vaccination site with scabbed lesion.
Age: 34.0
Sex: F
Vaccine: SMALL
Symptoms: Pruritus
Clinical narrative: On 03-20-03, day 7 post-vaccination, this primary vaccinee was noted to have several open skin tears and erythema surrounding the vaccination site with swelling of the arm distal from the vaccination site to slightly above the elbow.  Also reported swollen lymph nodes in the left axilla.  Vaccinee was advised to discontinue use of the semipermeable dressing and use gauze dressing until skin tears healed.  On day 8, reported use of hypoallergenic semipermeable dressing with decrease in erythema.  On 03-23-03, day 10 post-vaccination, vaccinee presented to local ER due to complaint of pain, intense itching, increased redness and swelling surrounding the vaccination site.  Vaccinee also reported sore mouth and throat described as feeling like ulcers.  Medical records indicate vaccinee was afrebrile with normal CBC; physical exam was reported significant for left axillary adenopathy, with a tender, swollen, reddened "band" with mild calor surrounding the vaccination site and encircling the left upper arm.  Diagnosis was recorded as "variant reaction to smallpox vaccination" with discharge home with prescription for Vicodin as needed for pain.  Assessment on day 14 post-vaccination revealed decrease in swelling and redness surrounding the site, lymph nodes in left axilla remained swollen but decrease in tenderness was reported.  Two new skin tears noted due to use of paper tape, previous skin tears healing.  Vaccinee reported now using gauze secured with "Kerlix type" wrap. By day 18 post-vaccination, swelling of arm and lymph nodes had resolved,  reported systemic symptoms resolved, minimal erythema noted surrounding the vaccination site, skin tears almost healed; vaccination site with scabbed lesion.
Age: 36.0
Sex: F
Vaccine: SMALL
Symptoms: Abdominal pain, Chest pain, Electrocardiogram abnormal, Hyperhidrosis, Hypotension
Clinical narrative: On the morning of 4/7/03, pt. developed diarrhea resolved with Immodium.  At approximately 6 pm of 4/7/03, pt. developed abdominal and chest pains, diaphoresis, and syncope. Pt. given 3 infant aspirin and sublingual Nitroglyercin x 2 without relief at place of work (hospital).  Taken to ER -BP measured 48/27, EKG abnormal (ST segment elevation, poor R wave).  Admitted to cardiology at Medical Center.  Discharged on 4/10/03.  Dx: Hypotension with hypovolemia.
Age: 36.0
Sex: F
Vaccine: SMALL
Symptoms: Hypovolaemia, Syncope
Clinical narrative: On the morning of 4/7/03, pt. developed diarrhea resolved with Immodium.  At approximately 6 pm of 4/7/03, pt. developed abdominal and chest pains, diaphoresis, and syncope. Pt. given 3 infant aspirin and sublingual Nitroglyercin x 2 without relief at place of work (hospital).  Taken to ER -BP measured 48/27, EKG abnormal (ST segment elevation, poor R wave).  Admitted to cardiology at Medical Center.  Discharged on 4/10/03.  Dx: Hypotension with hypovolemia.
Age: 33.0
Sex: M
Vaccine: SMALL
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Pt presented to local ED with fever to 104 with headache and myalgias (10 day out from Smallpox vaccination).  W/u exam all normal, pt followed up in 24 hours with significant resolution of symptoms.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site reaction
Clinical narrative: Cellulitis surrounding vaccine site in left deltoid began 1 1/2 days after vaccine. 10cm x 9 1/2 cm erythema and central induration.
Age: 24.0
Sex: F
Vaccine: SMALL
Symptoms: Rash vesicular
Clinical narrative: rash to dorsum of hands and right forearm - vesicular. Minimal to left hand- rash concentrated mostly to right forearm. Received vaccinia vaccination (L)armon 3/38/03.  Patient noted rash beginning on 4/05/03 and reported on 4/07/03.  MD diagnosis- "Generalized vaccinia vs contact dermatitis. Patient is HCW - restricted from work until rash resolves.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Death, Sudden infant death syndrome
Clinical narrative: Pt. died on 3/19/03, cause of death SIDS, death occured two days after immunizations.  No problems reported before or after shots.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: Pt. died on 3/19/03, cause of death SIDS, death occured two days after immunizations.  No problems reported before or after shots.
Sex: U
Vaccine: HIBV
Symptoms: Autism, Drug toxicity
Clinical narrative: A legal complaint was received from an attorney concerning a child who reportedly received Hib-Titer, Tri-Immunol, Engerix B, and DPT vaccines during the time frame of approximately 1992 through approximately 1997. The legal complaint states that the child subsequently developed toxic neurological effects of mercury poisoning (namely autism) as a result of receiving vaccinations containing thimerosal. Mercury poisoning and autism were considered medically important (OMIC).
Sex: M
Vaccine: HIBV
Symptoms: Autism, Drug toxicity, Nervous system disorder
Clinical narrative: A legal complaint was received from an attorney concerning a male child who reportedly received Hib-Titer, Tri-Immunol, Engerix B, Recombivax-HB, and DPT vaccines during the period from approximately 1997 to 1999. The legal complaint states that the child subsequently developed toxic neurological effects of mercury poisoning (namely autism) as a result of receiving vaccinations containing thimerosal. Mercury poisoning and autism were considered medically important (OMIC).
Sex: F
Vaccine: VARCEL
Symptoms: Unintended pregnancy
Clinical narrative: Information has been received through a manufacturer pregnancy registry from a female consumer who on 3/20/02 was vaccinated with one dose of varicella virus vaccine live. The pt started her menstrual cycle the following day on 3/21/02. Since then, the pt found out she was pregnant. Unspecified medical attention sought. Follow-up info from a nurse on 3/28/03 revealed that the pt had "several issues" and opted for termination of the pregnancy. Additional info has been requested. Reported on 04/22/2003: "On 05/02/2002 at six weeks gestation, a pregnancy termination was performed at a different facility.  It was unknown if the products of conception were examined and it was unknown if the fetus was normal.  No other medications were used during this pregnancy.  It was unknown if the patient was tested for varicella antibodies before vaccination with varicella virus vaccine live.  It was unknown if the patient had a local reaction at the vaccination site, varicella symptoms post vaccination or herpes zoster symptoms post vaccination.  The patient had 9 previous pregnancies including 2 full term births, a miscarriage during the first trimester and no pre-term births.  There were no birth defects in any previous pregnancy.  Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: OPV, VARCEL
Symptoms: Bacterial infection, Condition aggravated, Dermatitis bullous, Eczema, Infection
Clinical narrative: Information has been received from a physician concerning a 4 year old black female with eczema and no known drug allergies who on 9/17/99 was vaccinated in the left anterior thigh with a first dose of varicella virus vaccine live (lot # 630414/0302J). Concomitant vaccination therapy on 9/17/99 included a third dose of the oral polio virus vaccine (OPV)(lot #79906). Concomitant therapy included clotrimazole (unsuccessful treatment for tinea corpus), cefadroxil and fluconazole (secondary treatment for tinea, corpus, without success). On 12/30/02, while the patinet was noted to have tinea corpus, the physician noted herpetic lesions in a circular formation around the body tinea. It was noted that these lesions were not similar to typical chicken pox lesions and that they were painful but not pruritic. On 1/4/03 the vesicular lesions broke out in asynchronous fashion. These lesions were all over the patient except on the mucus membranes. The patient also presented with diffuse rash with erythematous, scaly areas and sloughening of the skin. Due to the atypical nature of this infection, the patient was hospitalized. The patient was diagnosed with chicken pox by the hospital pediatric infectious disease specialist. The patient also developed a secondary bacterial superinfection and developed a severe exacerbation of her eczema. The patient was hospitalized for 7 days and subsequently recovered. The reporter noted that chicken pox was disabling and also prolonged hospitalization. No further information is expected.
Age: 4.0
Sex: F
Vaccine: OPV, VARCEL
Symptoms: Rash erythematous, Skin exfoliation, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 4 year old black female with eczema and no known drug allergies who on 9/17/99 was vaccinated in the left anterior thigh with a first dose of varicella virus vaccine live (lot # 630414/0302J). Concomitant vaccination therapy on 9/17/99 included a third dose of the oral polio virus vaccine (OPV)(lot #79906). Concomitant therapy included clotrimazole (unsuccessful treatment for tinea corpus), cefadroxil and fluconazole (secondary treatment for tinea, corpus, without success). On 12/30/02, while the patinet was noted to have tinea corpus, the physician noted herpetic lesions in a circular formation around the body tinea. It was noted that these lesions were not similar to typical chicken pox lesions and that they were painful but not pruritic. On 1/4/03 the vesicular lesions broke out in asynchronous fashion. These lesions were all over the patient except on the mucus membranes. The patient also presented with diffuse rash with erythematous, scaly areas and sloughening of the skin. Due to the atypical nature of this infection, the patient was hospitalized. The patient was diagnosed with chicken pox by the hospital pediatric infectious disease specialist. The patient also developed a secondary bacterial superinfection and developed a severe exacerbation of her eczema. The patient was hospitalized for 7 days and subsequently recovered. The reporter noted that chicken pox was disabling and also prolonged hospitalization. No further information is expected.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Cerebellar ataxia
Clinical narrative: Information has been received from a neurologist concerning a 13 month old male with no medical history who was vaccinated with varicella virus vaccine live. The neurologist reported that, nine days after being vaccinated, the pt developed a rather severe cerebellar ataxia including a prominent symptom of opsoclonus. A MRI and EEG were both normal. Subsequently, the pt began to improve, being able to pull himself up, which he had not been able to do previously. Upon internal review, cerebellar ataxia was determined to be an other important medical event (OMIC). Additional info has been requested.
Age: 2.0
Sex: M
Vaccine: HEP
Symptoms: Abnormal behaviour, Autism, Cognitive disorder, Drug withdrawal syndrome
Clinical narrative: Information has been received from a legal firm regarding a case in litigation concerning a 24 month old male child who was injected with vaccines from 4/30/95 through at least 10/15/94, reportedly containing the mercury-based preservative thimerosal. The vaccines included at least the following: On 1/30/95, 4/3/95 and 12/1/95, the first, second and third doses of hep  B vaccine, recombivant (manuf unk). On 4/3/95 diphtheria, pertussis, and tetanus, oral polio vaccine, haemophilus influenza type B; on 5/31/95 diphtheria, pertussis, and tetanus, oral polio vaccine, haemophilus influenza type B; on 8/9/95 diphtheria, pertussis, and tetanus, haemophilus influenza type B; on 2/2/96 MMR vaccine live; on 5/8/96 haemophilus influenza type B; on 10/15/97 diphtheria, pertussis, and tetanus, and oral polio vaccine. It is alleged that after the pt was exposed to thimerosal, his behavior changed dramatically by the end of his second year. He avoided eye contact with his parents, indicated a strong preference for being left alone, and would bounce. He stopped talking and playing. In or around October 1998, he was diagnosed with autism. Upon internal review, the pt's autism was considered to be an important medical event (OMIC). No other info was available.
Sex: M
Vaccine: MMR
Symptoms: Cognitive disorder
Clinical narrative: Information has been received from a consumer concerning her son who approximately 4-5 years ago was vaccinated with a dose of MMR II and immediately stopped talking. The consumer reported that her son has had several years of speech therapy to correct the problem. Unspecified medical attention was sought. Upon internal review, stopped talking was considered an other important medical event (OMIC). Additional info is not expected.
Sex: M
Vaccine: HEP
Symptoms: Autism, Drug toxicity, Nervous system disorder
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male minor child who in 1994 was vaccinated with hep B vaccine recombinant. Concomitant therapy included HIB conjugate vaccine (HIBTITER) in 1994; Tripedia and HIB conjugate vaccine Haemophilus B conjugate vaccine (ACTHIB) in 1994 and 1995 and Acel-Imune in 1999. It has been alleged that through these vaccinations administered to the pt during the first several years of his life, he received very high doses of mercury contained in thimerosal, a highly toxic preservative. It has been further alleged that as a result of the mercury in the thimerosal containing vaccinations received during these developmental years, the pt suffered and in the future will continue to suffer from the toxic neurological effects of mercury poisoning, including but not limited to autism. Upon internal review, toxic neurolgoical effects, mercury poisoning, and autism were considered other important medical events (OMIC). No further info is available.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Rash erythematous, Rash maculo-papular, Rash pruritic
Clinical narrative: 37 y/o received his 2nd anthrax vaccine in his right upper arm on 11 Mar 03 and within 28 hours developed a pruritic, maculopapular, rash "that looks like insect bites" on his arms, legs, and torso. There are no reported systemic symptoms. He denies any change in bath soap, laundry detergent, lotions or any new food or contact substances. He is currently staying in a motel while awaiting deployment. he received anthrax # 1 and typhoid vaccines on 24 Feb without incidence. Pt has no prior history of allergies or chronic diseases, was not ill nor was he taking any medications when he received his vaccination. He has never had an adverse reaction to any vaccine. He is a smoker and occasionally drinks alcohol, but had not had anything to drink before or since the injection. Scattered erythermatous maculopapular lesions- 5-10 ml in size with some nodular in appearance with raised center, small lesions across back of neck and on right wrist in linear presentation. Dermatology consult requested. Picture taken and biopsy performed. Rx Lidex cream AAA tid: Allegra 180mg po qd: Zrytec 10mg po HS
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Hypokinesia, Injection site erythema, Injection site pain, Oedema
Clinical narrative: 21 y/o reports swollen muscles of his right arm "twice as big as normal and rock hard" and of his upper body within 48 hours of receiving his 2nd anthrax injection. He states no chronic health problems, has no drug allergies and was not taking any other medications at the time he received he injection. He reports receiving a steroid injection in Fen 03 for a sever case of poison ivy. His symptoms are as follows: Anthrax # 1 tenderness and a nodule that resolved in 2 weeks. Anthrax # 2 he received the injection the morning of 22 Mar 03 SQ in the right deltoid, with some localized redness and tenderness. He engaged in PT that evening. Upon awakening 24 Mar he states "I couldn't move, all the muscles of my upper body- both arms, shoulders and upper back- were swollen". He self medicated with OTC Motrin and was seen by his PCP, where he was given a steroid injection, advised to discontinue Motrin and started on a Medrol Dose Pac (twenty one 4 mg tablets to be tapered daily until gone). He also reports that his urine specimen was brown in color and high in protein.   Assessment: Myalgias bilateral upper arms and back temporally associated with receipt of anthrax vaccine. Proteinuria. Advised temporary exemption from anthrax injection until all swelling is resolved and UA is free of protein. Recommend change in route of next injection(ie give injection IM in deltoid muscle). Recommend pre treatment with topical steroid before next injection
Age: 19.0
Sex: M
Vaccine: ANTH, TTOX
Symptoms: Migraine, Nausea, Neuralgia, Pain
Clinical narrative: Woke up Wed. after 1st anthrax shot around 09:00 am in the morning. Very painful. Called out of work Wed. Went to doctors due to pinched nerve in back, right next to spine. Pain in neck all the way up. Gave such bad migraine I was nauseous. Still persistent and painful.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Chills, Dyspnoea, Erythema, Oedema
Clinical narrative: Received pneumococcal vaccine in afternoon. By the evening of sameday 02/28/2003, noticed swelling, redness, chills, fever, SOB. Seen in medical center 03/01/2003. Dx as possible cellulitus. Rx with Keflex 500mg qid x 10 day and Darvocat N 100 4-6 hours for pain. Seen in medical center 03/03/2003. Swelling decreased. Rx Predisone 20mg qd x 3 days with Keflex.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Received pneumococcal vaccine in afternoon. By the evening of sameday 02/28/2003, noticed swelling, redness, chills, fever, SOB. Seen in medical center 03/01/2003. Dx as possible cellulitus. Rx with Keflex 500mg qid x 10 day and Darvocat N 100 4-6 hours for pain. Seen in medical center 03/03/2003. Swelling decreased. Rx Predisone 20mg qd x 3 days with Keflex.
Age: 1.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Rash erythematous, Rash macular, Rash maculo-papular
Clinical narrative: Rash noted 9 days after vaccine. Multiple discrete erythematous macular, slight raised lesions post neck, post auricular, torso, and back. Fading lesions upper arms, thigh.
Sex: U
Vaccine: DTAP
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Area of increased redness, swelling, pain just below inject site. Ordered Benadryl 25 mg Q 4 hrs.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia, Screaming
Clinical narrative: 4 vax's given 4/7/03. DTaP, IPA, Hib, Prevnar. Seen 4/8 for fever (101.3), and inconsolable crying > 3 hrs. ?? exam.
Age: 51.0
Sex: M
Vaccine: PPV, TD
Symptoms: Injection site hypersensitivity, Injection site pain
Clinical narrative: PT received vax on 2/20/03 on left deltoid for tetanus and Pneumovax. Per PT 3-4 days later, left deltoid site red and tender to touch.
Age: 5.5
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site hypersensitivity, Injection site mass, Vasodilation procedure
Clinical narrative: Area of erythema over right deltoid (inject site) 17 cm by 14 cm induration and shoulder area. Warm to touch. Keflex given 960 with warm compasses. Follow up on 4/4/03 - improved.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Screaming
Clinical narrative: PT was given 2 month Imms swp? for 4 hrs after getting IMMS. Woke up and cried for 4-5 hrs.
Age: 1.6
Sex: F
Vaccine: DTAP, PNC
Symptoms: Rash vesicular
Clinical narrative: Chicken pox
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Injection site hypersensitivity, Injection site pain, Injection site reaction, Vasodilation procedure
Clinical narrative: Cellulitis right thigh (inject site) 4 x 4 inches - warmth, tenderness, erythema. Tx Rocephin 500 mg IM in office, Keflex 250 / 5 ml 2 tsp - ?? x 100
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Injection site hypersensitivity, Injection site mass, Injection site pain, Injection site reaction
Clinical narrative: Cellulitis left upper arm (inject site) following DTaP immunization 4 cm by 6 cm area - erythema, induration. Warmth and tenderness. Tx - Rocephin 500 mg IM in office - Keflex 250 mg / 5 ml. 3 ml PO TID x 1
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Vasodilation procedure
Clinical narrative: Cellulitis left upper arm (inject site) following DTaP immunization 4 cm by 6 cm area - erythema, induration. Warmth and tenderness. Tx - Rocephin 500 mg IM in office - Keflex 250 mg / 5 ml. 3 ml PO TID x 1
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: PT had redness / swelling left arm (inject site) with pain. 4/1/03 - much improved. Minimal local pain.
Age: 47.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Anaphylactic reaction, Confusional state, Dyspnoea, Hypertension, Hypoacusis
Clinical narrative: Could not breathe, heart rate and blood pressure very high (Anaphylaxis). Confused and not hearing very well.
Age: 47.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Tachycardia
Clinical narrative: Could not breathe, heart rate and blood pressure very high (Anaphylaxis). Confused and not hearing very well.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema
Clinical narrative: inches redness and swelling to right buttock by 2-3 inches.
Age: 7.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Rash , vesicular 50-100 lesions face all extremities.
Sex: M
Vaccine: DTAP, HEPA, HIBV, IPV
Symptoms: Oedema
Clinical narrative: Local swelling
Age: 2.0
Sex: M
Vaccine: HEPA, PNC
Symptoms: Injection site erythema, Injection site induration, Pain
Clinical narrative: Within 2 days after administration of Prevnar, child had apprx. 7cm diameter erythema and induration around injection site with pain to touch from elbow to shoulder.
Sex: M
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: Received immunization on 04/04/2003. Developed rash on 04/05/2003
Age: 12.0
Sex: F
Vaccine: HEP, MMR, TD
Symptoms: Convulsion, Drooling, Fatigue, Staring, Urinary incontinence
Clinical narrative: Client received hep B #1 on 1/19/99, #2 on 4/7/99, #3 on 8/10/99. Parents stated that child started acting strange 24 hrs after first Hp B vaccine. She started staring into space, complained of being tired and grades dropped over period of time. She had the first seizure on 8/6/99 at a friend's house and fell off the chair. After the second Hp B vaccine, she started drooling and wet the bed twice over a period of time. After the third vaccination, seizures became progressively worse. Child was under the care of the neurologist and medical services. On 10/13/01 child died in her sleep as a result of a "brain seizure."
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site hypersensitivity, Injection site induration, Injection site oedema
Clinical narrative: Reddness, itchy, edema localized to RD area 6x5 cm of redness- hard warm to touch. Benadryl 12.5-5ml 1/2 tsp q 4 hours
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Pruritus
Clinical narrative: Reddness, itchy, edema localized to RD area 6x5 cm of redness- hard warm to touch. Benadryl 12.5-5ml 1/2 tsp q 4 hours
Age: 50.0
Sex: F
Vaccine: SMALL
Symptoms: Chest discomfort, Dizziness, Malaise
Clinical narrative: 04/01/2003 pt c/o of dizziness on and off since SP vaccine Also reports "tightening of chest area" 2-3 times. Evaluated. Referred to UCI ED for evaluation. c/o dizzy and 4 days worse today. This is a 51 year old female who was sent from the health dept because she had diizziness and malaise for the past 4 days. Five days ago the pt reports that she had an episode of chest tightness that lasted 10 minutes. the pt has had no pain or discomfort in her chest since. The pt received a SP vaccine 1 week ago. The pt has no headache, change in mental status, change in vision, weakness, numbness, trouble thinking, talking or walking: no fever, no rash. Th health dept. doctor referred the pt here saying that her vaccine site appeared consistent with a normal reaction. The pt also has a history of having has SP as a child.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Headache, Malaise, Pain, Photophobia, Rash
Clinical narrative: Complained of body aches malaise on 1st day of sx with sudden onset of rash (shoulders, back, neck, back of head)the next day.  Gradual worsening with onset of HA and mild photophobia and admit to Tulane x 24 hrs.  No fever.  Supportive treatment.  Outpt follow-up showing gradual improvement with no rash as of 10 April.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Paraesthesia, Rash
Clinical narrative: Sudden onset of tingling in arms with rash.  Seen in ER and treated successfully with IM Benadryl.  Next day reoccurance of tingling but circumorally while in clinic.  Successfully treated again with IM Benadryl.
Age: 0.9
Sex: M
Vaccine: DTAP, HEP, IPV, PNC
Symptoms: Coma, Hypotonia
Clinical narrative: HV made to give late immunizations.  No problem noted.  Patient died 8 days later, had not been ill according to mother.  She had gone to town and he was limp and unresponsive when she got home.  They took him to MD and was pronounced dead.  Autopsy pending. (homicide suspected)
Age: 42.0
Sex: F
Vaccine: SMALL
Symptoms: Oedema, Pain, Pruritus, Rash
Clinical narrative: noted slight itching on different parts of body in the first 24 hours.  Day 2 noted rash chest to head. contacted Dr. and got benedryl.  med taken resolved  itching.  Noted pain and swelling around ankle and behind knees on day 5, lasted almost two weeks.
Age: 53.0
Sex: F
Vaccine: SMALL
Symptoms: Chest discomfort
Clinical narrative: After approximatley 4 hours after vaccination, pt. c/o of chest tightness.  Pt. self administered epinephrine injection and later took benadryl.  She stated she was fine after the treatments. (pt. is allergic to Bee Stings therefore she carrys epinephrine injections in case of an emergency).
Age: 53.0
Sex: F
Vaccine: SMALL
Symptoms: Abdominal pain, Chills, Nausea, Pyrexia
Clinical narrative: Chilss, nausea, fever - 100 degrees, stomach cramps for 3 days.  Took 8 pack of zithromax.
Age: 1.0
Sex: F
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Blister, Rash papular, Rash vesicular
Clinical narrative: GIVEN 1 YEAR IMMUNIZATIONS ON 4/7/03. ON 4/10/03 DEVELOPED RASH TO UE, LE, TRUNK, NECK. PRESENTED FOR EVAL 4/11/03. RASH IS DISCRETE PAPULES/EARLY VESICLES CONSISTANT WITH VARICELLA TYPE RASH. AFEBRILE. DOES NOT APPEAR TO BE PRURITIC. PT AFEBRILE. SEEN WITH PEDS (DR.) WHO FELT RASH WAS ALSO C/W VARICELLA.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Abnormal behaviour, Crying, Decreased appetite, Discomfort, Erythema
Clinical narrative: Within a few hours of vaccination, patient had fever, and bright red cheeks.  At dinner, had little appetite, and was clearly in distress, crying spontaneously, talking nonsensically.  A complete departure from previous behavior.  She slept well that night, and by morning, symptoms were gone.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: Within a few hours of vaccination, patient had fever, and bright red cheeks.  At dinner, had little appetite, and was clearly in distress, crying spontaneously, talking nonsensically.  A complete departure from previous behavior.  She slept well that night, and by morning, symptoms were gone.
Age: 56.0
Sex: F
Vaccine: SMALL
Symptoms: Bronchitis, Chest pain, Chills, Cough, Dyspnoea
Clinical narrative: F/U with family MD on 4/7/03 Dx'd muscle soreness d/t coughing from bronchitis. Prescribed add'l antibiotics. PT's statement: "I received a smallpox vax on 2/26/03. At the time of the vax I had been having a chronic cough for a few wks along w/occasional head congestion. I had not had any fever or other significant SXs and assumed I was just having some sinus drainage. A wk after the smallpox vax I had increased coughing, sore throat, body aches, and a low-grade fever that lasted for a couple days. The cough, especially at night, continued off and on along w/some head congestion. I used over the counter sinus and anti-histamine medications to treat the SXs. 3/22/03 I went on vacation to [other states]. In the middle of a gold game on 3/23, I developed chest pains and shortness of breath that lasted for approx an hour. That evening I developed a 102.8 temp, chills alternating w/sweats, increased coughing and severe body aches that lasted into the next day. I went to an ER that morning (3/24). My chest x-ray was essentially normal and the MD Dx'd bronchitis, sinusitis, and a bilateral ear infection and put me on Lavaquon 500 mg once/day for 6 days and a cough syrup. W/in 36 hrs the fever was gone, the cough was decreased and I was feeling better. I finished the antibiotic medication 3/29 and 2 days later I started back w/increased coughing, especially at night, and increased head congestion. I am not taking any over the counter medications at this time. I still have noticed brief episodes of chest pain and occasional shortness of breath off and on since the original episode on 3/23. I have a Hx of recent elevated blood pressure over the past year and am taking Lisinopril once per day. My blood pressure has been w/in normal ranges since taking the blood pressure med. I felt my SXs were probably due to the bronchitis/sinusitis. When the info came out regarding the cardiac SXs following the smallpox vax I was not sure if I should be concerned regarding the chest pains and shortness of breath related to the vax. Since those SXs did not start until 3-4 wks after the vax I did not know if it was likely to be related or not. I discussed this w/the nurse and she suggested I submit a written description [report].