chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HEP
Symptoms: Autism, Blood mercury abnormal
Clinical narrative: This case was reported by a consumer and described the occurrence of autism in a 1-day-old male subject who was vaccinated with ENGERIX B, (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  There were no concurrent medications.  On 26 June 2003 at 09:15 the subject received 1st dose of ENGERIX B (10 mcg, unknown, unknown thigh).  On 26 June 2003, the same day after vaccination with ENGERIX B, the subject experienced autism.  On an unspecified date, an unspecified time after vaccination with ENGERIX B, the subject experienced elevated blood mercury level.  The subject's mother called to question the lot number of ENGERIX B given a day after her son was born.  She called to find out what was in that particular product.  She stated that her son has been diagnosed with autism at the age of six and she just wanted to address some of her fears.  She stated that the subject has alot of mercury in his system and was concerned that her consent had caused this problem.  She was curious as to the potential of the vaccine causing autism.  This case was assessed as medically serious by GSK.  At the time of reporting the outcome of the events was unspecified.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Lobar pneumonia, Mycoplasma serology positive, Parainfluenzae virus infection, Pyrexia
Clinical narrative: Fever - started night after vaccine. Fever lasted 16 days. Parainfluenza type B sputum. Lt lower lobe pneumonia with positive rise in mycoplasma antibodies. Pt well @ time of shot.  8/6/09 Hospital records received DOS 5/15/09 to 5/24/09. Assessment: Mycoplasma pneumonia. Patient initially dx'd with urinary tract infection and viral infection Admitted to another facility. Patient then transferred from that facility due to left lower lobe pneumonia. Patient presents with fever, chills, headaches, nonproductive cough, posttussive emesis, and decreased appetite. Back pain.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Blister
Clinical narrative: Received smallpox vaccination on 7/21/09. Subsequently had blisters all over his back and chest. He was taken to Emergency Room and admitted for 3 days.  8/17/09 Hospital records received DOS 8/2/09 to 8/5/09. Assessment: Generalized Vaccinia. Patient presents with rash primarily on back and chest. Some on face and leg. Chills, Multiple pustular lesions, yellowish papules, some erythema, pain, yellow drainage.  9/14/09 ICD-9 Codes: 7821 rash, 999.0 Generalized vaccinia.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: 7-8" of redness, itchy and painful for 1 wk.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever, rash.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Oedema peripheral, Pyrexia, Tenderness
Clinical narrative: (R) arm red swollen X 2 days; tender - Fever increase 101.0. - Will treat  KEFLEX 500mg #30 T po tid for 10 days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong technique in drug usage process
Clinical narrative: Vaccine was given IM rather than Subq.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Pt fainted following immunization.  Pt was sitting in chair during administration & fainted following 4th vaccine.  Pt was still in chair when he fainted.  Pt was unconscious for approx. 30 seconds.  Pt. rec'd all vaccines in full before fainting.  Pt. stayed for 25 minutes a walking out to car with mom.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Oropharyngeal blistering, Rash
Clinical narrative: Rash to hands and feet (blisters) sores in mouth. Treated with ZYRTEC and BENADRYL mouth wash mixture.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass
Clinical narrative: On 27 July 09 child received 3rd HPV vaccine in left arm. On 28 July 09 a lump was seen over injection area. Was seen on 29 July for a check up again on 31 July 09 the lump was slightly smaller. No treatment received or required.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Eye swelling, Eyelid oedema
Clinical narrative: Patient woke up on 7-11-09 and her eyes were puffy both the top + bottom lids.  No itching or burning.  Eye eyes are still puffy 2 wks later.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Chills, Pain, Pain in extremity
Clinical narrative: 7/6 Arm aches pm. 7/7 Body aches, Temp low grade, chills.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Dizziness, Dyspnoea, Headache, Hyperhidrosis
Clinical narrative: Neck stiffness, Headache, Extreme sweating, chest pain, diff. Breathing, and feeling faint.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal stiffness
Clinical narrative: Neck stiffness, Headache, Extreme sweating, chest pain, diff. Breathing, and feeling faint.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Cyanosis, Erythema, Injected limb mobility decreased, Oedema peripheral, Pain in extremity
Clinical narrative: 7-27-09 1:00 PM Mom called to report daughter's (R) arm was red, swollen and real sore. She also couldn't pick up her arm very high. Mom called back at 4: 00 PM. Her (R) arm was hot to touch and her (R) arm from elbow to hands were turning purplish blue - went to ER.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Skin warm
Clinical narrative: 7-27-09 1:00 PM Mom called to report daughter's (R) arm was red, swollen and real sore. She also couldn't pick up her arm very high. Mom called back at 4: 00 PM. Her (R) arm was hot to touch and her (R) arm from elbow to hands were turning purplish blue - went to ER.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Hypersensitivity, Rash maculo-papular
Clinical narrative: Patient returned to clinic after 30 min from receiving vaccines reporting an allergic reaction. Patient presented with macular papular rash on left cheek. No SOB, no itching. Overall feeling fine.
Age: 18.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Dizziness, Heart rate normal, Presyncope
Clinical narrative: Dizziness, 0 Syncope, diaphoretic with within normal vs: BP 116/76, HR:84, RR:18. Treated for Vasovagal symptoms and monitored vitals.
Age: 1.15
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Idiopathic thrombocytopenic purpura, Platelet count decreased
Clinical narrative: Pt 2 wks after MMR/Varicella developed full blown TIP w/ platelets down to 4K! Referred to Hematologist.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Dyspnoea, Hyperventilation, Pain in extremity
Clinical narrative: According to parents woke up next day with leg pain then had trouble breathing - taken to hospital ER - Dx Hyperventilation according to MD. 1/8/2010 ED records for 7/24/2009, patient with c/o's joint pain, tx; toradol DC Dx Arthralgias, reaction to vaccine
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: 2-3" circular redness-itchy and painful to touch for 1 week.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Erythema, Pruritus, Rash maculo-papular, Swelling face
Clinical narrative: Night of immunization mac/pap rash of face and neck with some swelling of face with erythema and itching. Resolved in 2 weeks time with Zyrtec. No vesicles. Brother received varicella at same time.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Ultrasound scan
Clinical narrative: Vaccine administered to pregnant female approximated 3 weeks gestation. Report LMP 5/5/09, denied sexual activity. EDC 2/4/10.
Sex: M
Vaccine: SMALL
Symptoms: Blister, Scab
Clinical narrative: Possible secondary innoculation to genital area. Mutiple vesicles with crusting to penis.
Age: 60.0
Sex: F
Vaccine: DTAP
Symptoms: Influenza like illness, Injection site pain, Myalgia, Pain, Pyrexia
Clinical narrative: After a few hours the injected arm upper muscles ached when lifting or raised. Following day flu-like symptoms - achy, slight fever. Next day fine...on day four lost equilibrium and required medication to alleviate problem. Currently, my arm is still NOT OK when lifting or raising...somewhat incapacitating.
Age: 60.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia oral, Lip swelling
Clinical narrative: TETANUS SHOT WAS GIVEN ON LEFT ARM, UPPER LEFT SIDE OF PATIENT'S LIP STARTED TO SWELL.BY 10 PM HIS ENTIRE UPPER LIP WAS SWOLLEN AND NUMB.THIS MORNING IT SEEMS LIKE ITS GOING DOWN. ORDERED TO TAKE BENADRYL
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Abdominal pain upper, Nausea, Vomiting
Clinical narrative: Childs mother called at 9:30am this morning reporting that the child had nausea and vomiting during the night. She stated child vomited once during the night and once early this morning. Reports stomach "pain". Mother denied child had a fever. Mother stated she had not treated the child with any medications.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site nodule, Injection site rash, Injection site warmth
Clinical narrative: Patient presented 8/3/2009 concerned and with a larger than expected rash and warm, palpable, approximately 2 to 3 cm nodule at the area of administration.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: 24 hours after vaccine, arm had slight itching and faint redness (0.75" x 1.0" oval) where vaccine was administered. Itching and redness have gone away 7 days after vaccine given.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Syncopal episode 2 minutes after immunizations.  Fell to floor. B/P 98/64; Pulse 83; Oxygen sat 98%.  Legs elevated.  Recovered without incident; denies pain.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Redness, swellling and induration over the Left upper arm from the shoulder to mid-upper arm.  Tender to palpation.  No fluctuance
Age: 23.0
Sex: F
Vaccine: HIBV, MNQ, PPV, MEN, HIBV, MNQ, PPV
Symptoms: Computerised tomogram normal, Dyspnoea, Haemoglobin decreased, Injection site pain, Lethargy
Clinical narrative: Approximately 1 week prior patient was admitted into the hospital after a 2-story fall that subsequently required her to undergo a splenectomy on 7/27/09. Prior to discharge the vaccinations were ordered and given on 8/1/09. The patient returned to the Emergency department with fever of 104, increasing abdominal pain, severe pain in left lateral thigh where vaccines were given and some dyspnea. Patient became increasingly lethargic and developed a macular rash. She reported urinary urgency but unable to void. Mother accompanied patient to the ED and reported that every time she received vaccinations as a child the patient would develop terrible fevers and injection site reaction. Patient was admitted into the intensive care unit and medically managed for serum sickness secondary to vaccine administration. 8/31/09-records received for DOS 7/28-8/1/09-DC DX: Systemic inflammatory response syndrome from immunization (serum sickness). Hyponatremia. Dehyrdration. Fever. Lethargy. Hypoabluminemia. Thrombocytosis. On day of discharge received vaccines subsequently seen in ED for fever. Developed truncal rash, complaints of left thigh pain, lethargy, tachycardic, hypotensive. Impression: systemic inflammatory response syndrome most likely related to vaccine and allergic reation.  ICD-9 codes: 865.03. 958.4, 864.85, 285.1, E882, E849.0, 300.00 and 238.71.
Age: 23.0
Sex: F
Vaccine: HIBV, MNQ, PPV, MEN, HIBV, MNQ, PPV
Symptoms: Micturition urgency, Pyrexia, Rash macular, Red blood cell count decreased, Serum sickness
Clinical narrative: Approximately 1 week prior patient was admitted into the hospital after a 2-story fall that subsequently required her to undergo a splenectomy on 7/27/09. Prior to discharge the vaccinations were ordered and given on 8/1/09. The patient returned to the Emergency department with fever of 104, increasing abdominal pain, severe pain in left lateral thigh where vaccines were given and some dyspnea. Patient became increasingly lethargic and developed a macular rash. She reported urinary urgency but unable to void. Mother accompanied patient to the ED and reported that every time she received vaccinations as a child the patient would develop terrible fevers and injection site reaction. Patient was admitted into the intensive care unit and medically managed for serum sickness secondary to vaccine administration. 8/31/09-records received for DOS 7/28-8/1/09-DC DX: Systemic inflammatory response syndrome from immunization (serum sickness). Hyponatremia. Dehyrdration. Fever. Lethargy. Hypoabluminemia. Thrombocytosis. On day of discharge received vaccines subsequently seen in ED for fever. Developed truncal rash, complaints of left thigh pain, lethargy, tachycardic, hypotensive. Impression: systemic inflammatory response syndrome most likely related to vaccine and allergic reation.  ICD-9 codes: 865.03. 958.4, 864.85, 285.1, E882, E849.0, 300.00 and 238.71.
Age: 23.0
Sex: F
Vaccine: HIBV, MNQ, PPV, MEN, HIBV, MNQ, PPV
Symptoms: Urinary retention, White blood cell count increased
Clinical narrative: Approximately 1 week prior patient was admitted into the hospital after a 2-story fall that subsequently required her to undergo a splenectomy on 7/27/09. Prior to discharge the vaccinations were ordered and given on 8/1/09. The patient returned to the Emergency department with fever of 104, increasing abdominal pain, severe pain in left lateral thigh where vaccines were given and some dyspnea. Patient became increasingly lethargic and developed a macular rash. She reported urinary urgency but unable to void. Mother accompanied patient to the ED and reported that every time she received vaccinations as a child the patient would develop terrible fevers and injection site reaction. Patient was admitted into the intensive care unit and medically managed for serum sickness secondary to vaccine administration. 8/31/09-records received for DOS 7/28-8/1/09-DC DX: Systemic inflammatory response syndrome from immunization (serum sickness). Hyponatremia. Dehyrdration. Fever. Lethargy. Hypoabluminemia. Thrombocytosis. On day of discharge received vaccines subsequently seen in ED for fever. Developed truncal rash, complaints of left thigh pain, lethargy, tachycardic, hypotensive. Impression: systemic inflammatory response syndrome most likely related to vaccine and allergic reation.  ICD-9 codes: 865.03. 958.4, 864.85, 285.1, E882, E849.0, 300.00 and 238.71.
Age: 23.0
Sex: F
Vaccine: HIBV, MNQ, PPV, MEN, HIBV, MNQ, PPV
Symptoms: Abdomen scan normal, Abdominal pain, Blood albumin decreased, Blood creatinine normal, Dyspnoea
Clinical narrative: Approximately 1 week prior patient was admitted into the hospital after a 2-story fall that subsequently required her to undergo a splenectomy on 7/27/09. Prior to discharge the vaccinations were ordered and given on 8/1/09. The patient returned to the Emergency department with fever of 104, increasing abdominal pain, severe pain in left lateral thigh where vaccines were given and some dyspnea. Patient became increasingly lethargic and developed a macular rash. She reported urinary urgency but unable to void. Mother accompanied patient to the ED and reported that every time she received vaccinations as a child the patient would develop terrible fevers and injection site reaction. Patient was admitted into the intensive care unit and medically managed for serum sickness secondary to vaccine administration. 8/31/09-records received for DOS 7/28-8/1/09-DC DX: Systemic inflammatory response syndrome from immunization (serum sickness). Hyponatremia. Dehyrdration. Fever. Lethargy. Hypoabluminemia. Thrombocytosis. On day of discharge received vaccines subsequently seen in ED for fever. Developed truncal rash, complaints of left thigh pain, lethargy, tachycardic, hypotensive. Impression: systemic inflammatory response syndrome most likely related to vaccine and allergic reation.  ICD-9 codes: 865.03. 958.4, 864.85, 285.1, E882, E849.0, 300.00 and 238.71.
Age: 23.0
Sex: F
Vaccine: HIBV, MNQ, PPV, MEN, HIBV, MNQ, PPV
Symptoms: Haematocrit decreased, Haemoglobin decreased, Heart rate increased, Injection site pain, Lethargy
Clinical narrative: Approximately 1 week prior patient was admitted into the hospital after a 2-story fall that subsequently required her to undergo a splenectomy on 7/27/09. Prior to discharge the vaccinations were ordered and given on 8/1/09. The patient returned to the Emergency department with fever of 104, increasing abdominal pain, severe pain in left lateral thigh where vaccines were given and some dyspnea. Patient became increasingly lethargic and developed a macular rash. She reported urinary urgency but unable to void. Mother accompanied patient to the ED and reported that every time she received vaccinations as a child the patient would develop terrible fevers and injection site reaction. Patient was admitted into the intensive care unit and medically managed for serum sickness secondary to vaccine administration. 8/31/09-records received for DOS 7/28-8/1/09-DC DX: Systemic inflammatory response syndrome from immunization (serum sickness). Hyponatremia. Dehyrdration. Fever. Lethargy. Hypoabluminemia. Thrombocytosis. On day of discharge received vaccines subsequently seen in ED for fever. Developed truncal rash, complaints of left thigh pain, lethargy, tachycardic, hypotensive. Impression: systemic inflammatory response syndrome most likely related to vaccine and allergic reation.  ICD-9 codes: 865.03. 958.4, 864.85, 285.1, E882, E849.0, 300.00 and 238.71.
Age: 23.0
Sex: F
Vaccine: HIBV, MNQ, PPV, MEN, HIBV, MNQ, PPV
Symptoms: Leukocytosis, Micturition urgency, Platelet count increased, Pyrexia, Rash macular
Clinical narrative: Approximately 1 week prior patient was admitted into the hospital after a 2-story fall that subsequently required her to undergo a splenectomy on 7/27/09. Prior to discharge the vaccinations were ordered and given on 8/1/09. The patient returned to the Emergency department with fever of 104, increasing abdominal pain, severe pain in left lateral thigh where vaccines were given and some dyspnea. Patient became increasingly lethargic and developed a macular rash. She reported urinary urgency but unable to void. Mother accompanied patient to the ED and reported that every time she received vaccinations as a child the patient would develop terrible fevers and injection site reaction. Patient was admitted into the intensive care unit and medically managed for serum sickness secondary to vaccine administration. 8/31/09-records received for DOS 7/28-8/1/09-DC DX: Systemic inflammatory response syndrome from immunization (serum sickness). Hyponatremia. Dehyrdration. Fever. Lethargy. Hypoabluminemia. Thrombocytosis. On day of discharge received vaccines subsequently seen in ED for fever. Developed truncal rash, complaints of left thigh pain, lethargy, tachycardic, hypotensive. Impression: systemic inflammatory response syndrome most likely related to vaccine and allergic reation.  ICD-9 codes: 865.03. 958.4, 864.85, 285.1, E882, E849.0, 300.00 and 238.71.
Age: 23.0
Sex: F
Vaccine: HIBV, MNQ, PPV, MEN, HIBV, MNQ, PPV
Symptoms: Reaction to previous exposure to any vaccine, Red blood cell count decreased, Urinary retention, White blood cell count increased
Clinical narrative: Approximately 1 week prior patient was admitted into the hospital after a 2-story fall that subsequently required her to undergo a splenectomy on 7/27/09. Prior to discharge the vaccinations were ordered and given on 8/1/09. The patient returned to the Emergency department with fever of 104, increasing abdominal pain, severe pain in left lateral thigh where vaccines were given and some dyspnea. Patient became increasingly lethargic and developed a macular rash. She reported urinary urgency but unable to void. Mother accompanied patient to the ED and reported that every time she received vaccinations as a child the patient would develop terrible fevers and injection site reaction. Patient was admitted into the intensive care unit and medically managed for serum sickness secondary to vaccine administration. 8/31/09-records received for DOS 7/28-8/1/09-DC DX: Systemic inflammatory response syndrome from immunization (serum sickness). Hyponatremia. Dehyrdration. Fever. Lethargy. Hypoabluminemia. Thrombocytosis. On day of discharge received vaccines subsequently seen in ED for fever. Developed truncal rash, complaints of left thigh pain, lethargy, tachycardic, hypotensive. Impression: systemic inflammatory response syndrome most likely related to vaccine and allergic reation.  ICD-9 codes: 865.03. 958.4, 864.85, 285.1, E882, E849.0, 300.00 and 238.71.
Age: 23.0
Sex: F
Vaccine: HIBV, MNQ, PPV, MEN, HIBV, MNQ, PPV
Symptoms: Abdominal pain, Blood albumin decreased, Blood creatinine decreased, Blood creatinine normal, Body temperature increased
Clinical narrative: Approximately 1 week prior patient was admitted into the hospital after a 2-story fall that subsequently required her to undergo a splenectomy on 7/27/09. Prior to discharge the vaccinations were ordered and given on 8/1/09. The patient returned to the Emergency department with fever of 104, increasing abdominal pain, severe pain in left lateral thigh where vaccines were given and some dyspnea. Patient became increasingly lethargic and developed a macular rash. She reported urinary urgency but unable to void. Mother accompanied patient to the ED and reported that every time she received vaccinations as a child the patient would develop terrible fevers and injection site reaction. Patient was admitted into the intensive care unit and medically managed for serum sickness secondary to vaccine administration. 8/31/09-records received for DOS 7/28-8/1/09-DC DX: Systemic inflammatory response syndrome from immunization (serum sickness). Hyponatremia. Dehyrdration. Fever. Lethargy. Hypoabluminemia. Thrombocytosis. On day of discharge received vaccines subsequently seen in ED for fever. Developed truncal rash, complaints of left thigh pain, lethargy, tachycardic, hypotensive. Impression: systemic inflammatory response syndrome most likely related to vaccine and allergic reation.  ICD-9 codes: 865.03. 958.4, 864.85, 285.1, E882, E849.0, 300.00 and 238.71.
Age: 23.0
Sex: F
Vaccine: HIBV, MNQ, PPV, MEN, HIBV, MNQ, PPV
Symptoms: Computerised tomogram normal, Dyspnoea, Dysuria, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: Approximately 1 week prior patient was admitted into the hospital after a 2-story fall that subsequently required her to undergo a splenectomy on 7/27/09. Prior to discharge the vaccinations were ordered and given on 8/1/09. The patient returned to the Emergency department with fever of 104, increasing abdominal pain, severe pain in left lateral thigh where vaccines were given and some dyspnea. Patient became increasingly lethargic and developed a macular rash. She reported urinary urgency but unable to void. Mother accompanied patient to the ED and reported that every time she received vaccinations as a child the patient would develop terrible fevers and injection site reaction. Patient was admitted into the intensive care unit and medically managed for serum sickness secondary to vaccine administration. 8/31/09-records received for DOS 7/28-8/1/09-DC DX: Systemic inflammatory response syndrome from immunization (serum sickness). Hyponatremia. Dehyrdration. Fever. Lethargy. Hypoabluminemia. Thrombocytosis. On day of discharge received vaccines subsequently seen in ED for fever. Developed truncal rash, complaints of left thigh pain, lethargy, tachycardic, hypotensive. Impression: systemic inflammatory response syndrome most likely related to vaccine and allergic reation.  ICD-9 codes: 865.03. 958.4, 864.85, 285.1, E882, E849.0, 300.00 and 238.71.
Age: 23.0
Sex: F
Vaccine: HIBV, MNQ, PPV, MEN, HIBV, MNQ, PPV
Symptoms: Heart rate increased, Injection site pain, Lethargy, Leukocytosis, Micturition urgency
Clinical narrative: Approximately 1 week prior patient was admitted into the hospital after a 2-story fall that subsequently required her to undergo a splenectomy on 7/27/09. Prior to discharge the vaccinations were ordered and given on 8/1/09. The patient returned to the Emergency department with fever of 104, increasing abdominal pain, severe pain in left lateral thigh where vaccines were given and some dyspnea. Patient became increasingly lethargic and developed a macular rash. She reported urinary urgency but unable to void. Mother accompanied patient to the ED and reported that every time she received vaccinations as a child the patient would develop terrible fevers and injection site reaction. Patient was admitted into the intensive care unit and medically managed for serum sickness secondary to vaccine administration. 8/31/09-records received for DOS 7/28-8/1/09-DC DX: Systemic inflammatory response syndrome from immunization (serum sickness). Hyponatremia. Dehyrdration. Fever. Lethargy. Hypoabluminemia. Thrombocytosis. On day of discharge received vaccines subsequently seen in ED for fever. Developed truncal rash, complaints of left thigh pain, lethargy, tachycardic, hypotensive. Impression: systemic inflammatory response syndrome most likely related to vaccine and allergic reation.  ICD-9 codes: 865.03. 958.4, 864.85, 285.1, E882, E849.0, 300.00 and 238.71.
Age: 23.0
Sex: F
Vaccine: HIBV, MNQ, PPV, MEN, HIBV, MNQ, PPV
Symptoms: Platelet count increased, Pyrexia, Rash macular, Red blood cell count decreased, Serum sickness
Clinical narrative: Approximately 1 week prior patient was admitted into the hospital after a 2-story fall that subsequently required her to undergo a splenectomy on 7/27/09. Prior to discharge the vaccinations were ordered and given on 8/1/09. The patient returned to the Emergency department with fever of 104, increasing abdominal pain, severe pain in left lateral thigh where vaccines were given and some dyspnea. Patient became increasingly lethargic and developed a macular rash. She reported urinary urgency but unable to void. Mother accompanied patient to the ED and reported that every time she received vaccinations as a child the patient would develop terrible fevers and injection site reaction. Patient was admitted into the intensive care unit and medically managed for serum sickness secondary to vaccine administration. 8/31/09-records received for DOS 7/28-8/1/09-DC DX: Systemic inflammatory response syndrome from immunization (serum sickness). Hyponatremia. Dehyrdration. Fever. Lethargy. Hypoabluminemia. Thrombocytosis. On day of discharge received vaccines subsequently seen in ED for fever. Developed truncal rash, complaints of left thigh pain, lethargy, tachycardic, hypotensive. Impression: systemic inflammatory response syndrome most likely related to vaccine and allergic reation.  ICD-9 codes: 865.03. 958.4, 864.85, 285.1, E882, E849.0, 300.00 and 238.71.
Age: 23.0
Sex: F
Vaccine: HIBV, MNQ, PPV, MEN, HIBV, MNQ, PPV
Symptoms: White blood cell count increased
Clinical narrative: Approximately 1 week prior patient was admitted into the hospital after a 2-story fall that subsequently required her to undergo a splenectomy on 7/27/09. Prior to discharge the vaccinations were ordered and given on 8/1/09. The patient returned to the Emergency department with fever of 104, increasing abdominal pain, severe pain in left lateral thigh where vaccines were given and some dyspnea. Patient became increasingly lethargic and developed a macular rash. She reported urinary urgency but unable to void. Mother accompanied patient to the ED and reported that every time she received vaccinations as a child the patient would develop terrible fevers and injection site reaction. Patient was admitted into the intensive care unit and medically managed for serum sickness secondary to vaccine administration. 8/31/09-records received for DOS 7/28-8/1/09-DC DX: Systemic inflammatory response syndrome from immunization (serum sickness). Hyponatremia. Dehyrdration. Fever. Lethargy. Hypoabluminemia. Thrombocytosis. On day of discharge received vaccines subsequently seen in ED for fever. Developed truncal rash, complaints of left thigh pain, lethargy, tachycardic, hypotensive. Impression: systemic inflammatory response syndrome most likely related to vaccine and allergic reation.  ICD-9 codes: 865.03. 958.4, 864.85, 285.1, E882, E849.0, 300.00 and 238.71.
Age: 2.0
Sex: M
Vaccine: DTAPIPV, PNC
Symptoms: No adverse event
Clinical narrative: Pt given combo vaccine of Dtap/IPV. Pt contacted. No adverse s/s reported by pt.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Balance disorder, Blood test, Confusional state, Hypoaesthesia
Clinical narrative: Approximately 1 month after receiving the second dose of the Gardasil vaccine (manufactured by Merck - I am unable to load that in the information section below), I began experiencing numbness in my right leg. The numbness was persistent and progressive - it began in the right leg, but soon spread to the left leg, as well as my face and tongue. I also experienced poor balance, poor vision, confusion, and overall weakness. I was admitted to the hospital 3 weeks later, and kept for one week while receiving intravenous corticosteroids as treatment. 8/24/09 consultant records 1/09-received for numbness of right leg below knee right face and tongue numbness between Oct 07 and Feb 08 when symptoms improved and then in March 08 recurrent symptoms. Developed diplopia, dizziness, cognitive impairment, abdominal problems and fatigue. Impression: MS.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia facial, Hypoaesthesia oral, Lumbar puncture, Visual acuity reduced, X-ray
Clinical narrative: Approximately 1 month after receiving the second dose of the Gardasil vaccine (manufactured by Merck - I am unable to load that in the information section below), I began experiencing numbness in my right leg. The numbness was persistent and progressive - it began in the right leg, but soon spread to the left leg, as well as my face and tongue. I also experienced poor balance, poor vision, confusion, and overall weakness. I was admitted to the hospital 3 weeks later, and kept for one week while receiving intravenous corticosteroids as treatment. 8/24/09 consultant records 1/09-received for numbness of right leg below knee right face and tongue numbness between Oct 07 and Feb 08 when symptoms improved and then in March 08 recurrent symptoms. Developed diplopia, dizziness, cognitive impairment, abdominal problems and fatigue. Impression: MS.
Age: 1.31
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Convulsion
Clinical narrative: Pt had a seizure 2:00 a.m. the following morning. Went to Emergency room for evaluation.  Did not require hospitalization.
Age: 36.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Blood creatine phosphokinase normal, Metabolic function test, Muscle spasms, Pain
Clinical narrative: had body aches and muscle cramps day after recieving anthrax.  The cramping continued for 3 days after.
Age: 14.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Pain, Rash, Rash pruritic
Clinical narrative: Herpes Zoster Rash on trunk on the Right side in Dermatomal Distribution.Seen at clinic for rash and diagnosed on 07/29/09.As of 8/3/09 per telephone consult with mother,he still had the rash (7 days after onset). The rash is pruritic and he has been experiencing pain but is not taking Tylenol as recommended.The rash is reported to be drying up and has not spread elsewhere.Patient has not developed any other new symptoms.
Age: 1.61
Sex: M
Vaccine: HEPA
Symptoms: Blood test normal, CSF culture negative, CSF test normal, Computerised tomogram normal, Convulsion
Clinical narrative: Pt received second Hep A vaccine about 4pm in pediatrician's office without immediate effect.  The next day at about 6 pm (26 hrs later) pt had a generalized seizure lasting at least 45 min that required Diastat then IV Ativan to control.  Fever of 104.6 F rectal in ER.  Normal CT of head, lumbar puncture/CSF analysis, blood/urine/CSF cx.  Pt received 48 hours of Rocephin, inpatient at hospital for 24 hours and recovered apparently fully.  EEG normal.  8/12/09 MR received for DOS   with DX:  Complex Febrile Seizure.  Pt presented after prolonged (on & off for ~45 minutes) seizure activity.  Agitated and crying upon arrival to ED.  PE (+) for post-ictal state, red TMs bilat, and occ tremor.
Age: 1.61
Sex: M
Vaccine: HEPA
Symptoms: Electroencephalogram normal, Lumbar puncture normal, Pyrexia, Urine analysis normal
Clinical narrative: Pt received second Hep A vaccine about 4pm in pediatrician's office without immediate effect.  The next day at about 6 pm (26 hrs later) pt had a generalized seizure lasting at least 45 min that required Diastat then IV Ativan to control.  Fever of 104.6 F rectal in ER.  Normal CT of head, lumbar puncture/CSF analysis, blood/urine/CSF cx.  Pt received 48 hours of Rocephin, inpatient at hospital for 24 hours and recovered apparently fully.  EEG normal.  8/12/09 MR received for DOS   with DX:  Complex Febrile Seizure.  Pt presented after prolonged (on & off for ~45 minutes) seizure activity.  Agitated and crying upon arrival to ED.  PE (+) for post-ictal state, red TMs bilat, and occ tremor.
Age: 10.0
Sex: F
Vaccine: HEPA
Symptoms: Cold sweat, Dizziness, Dysstasia, Hyperhidrosis, Nausea
Clinical narrative: About one minute after shot patient became dizzy. She told me numerous times that something was wrong and and that she did not feel good. She turned a pale green color in face. She had nausea and could not stand up straight. She had to lean on rail in hallway so she would not fall. At nurses station she could not sit up in chair and had to sit on ground with head on chair. Her lips turned white. She started sweating and became very clammy. She was not able to get up so nurse helped her up and walked her by her arm to the car so she would not fall. Nurse told me that these are not usually side effects of Hep A shot and if she got worse to bring her back.
Age: 10.0
Sex: F
Vaccine: HEPA
Symptoms: Skin discolouration
Clinical narrative: About one minute after shot patient became dizzy. She told me numerous times that something was wrong and and that she did not feel good. She turned a pale green color in face. She had nausea and could not stand up straight. She had to lean on rail in hallway so she would not fall. At nurses station she could not sit up in chair and had to sit on ground with head on chair. Her lips turned white. She started sweating and became very clammy. She was not able to get up so nurse helped her up and walked her by her arm to the car so she would not fall. Nurse told me that these are not usually side effects of Hep A shot and if she got worse to bring her back.
Age: 0.5
Sex: M
Vaccine: DTAPH, PPV, RVX
Symptoms: Medication error, Rash generalised
Clinical narrative: Child had 6 month shots at 11:00am. There was no food given besides formula after shots. At 18:30 rapid rash developed over the baby. Starting on he lower back moving to the head and then down to the chest. No treatment was given per doctors on call order that night. 13 days later rash is still present.
Age: 18.0
Sex: M
Vaccine: MEN, TD
Symptoms: Cold sweat, Headache, Heart rate increased, Sensory disturbance
Clinical narrative: Shots administered at 2:30 p.m. appointment which include TD and Meningococcal. Patient felt fine going into appointment for vacines. Later at 9:00p.m. patient feels like arms are spaghetti feeling he had no feeling in arms and headache only in frontal part of skull from forehead to top of head only in center of head. Also fast heartbeat and clammy to the touch. Will watch all night to be sure nothing happens and will go to hospital if symptoms continue.
Age: 0.24
Sex: F
Vaccine: DTAP, RV5, DTAP, RV5
Symptoms: Intussusception, Surgery
Clinical narrative: Intussusception 7/20/09 - symptoms began. Required surgical reduction 7/22/09.  8/31/09 Hospital records received DOS 7/20/09 to 7/28/09. Assessment: Intussusception. Infant had increased sweating, drowsy, pale, not arousable or responding. having tremors all 4 limbs and shaking. Decreased urine output. Projectile vomiting decreased appetite. Dehydration. Greenish mucousy stools. Fever. Barium enema reduction unsuccessful. Laparotomy, ileocectomy, ileo ascending colostomy anastomosis.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia, Oedema peripheral, Pain in extremity, Paraesthesia
Clinical narrative: 6/23/09 BOOSTRIX given -> mild soreness/ swelling post injection Lt arm.  A "few days later" developed " electrical sensation" in arm -> Palm of hand.  8/4/09. Still with Lt. arm pain & numbness in Lt. arm.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Drug screen, Grand mal convulsion
Clinical narrative: Pt has history of seizures. Has C.P. She developed grand mal seizures the day after BOOSTRIX given.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Hyperhidrosis, Nausea, Rash
Clinical narrative: Sweating, dizzy, nausea, rash on face, neck.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Body temperature increased, Decreased appetite, Injection site swelling, Lethargy
Clinical narrative: Temp 101 F x 2 days of markedly swollen (L) arm, shoulder and elbow x 4 days. C/O decreased appetite and lethargy x 2 days.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Body temperature increased
Clinical narrative: Temp of 103.1 a few hrs after getting vaccines. Given Ibuprofen by his mother.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Local reaction, Rash papular, Skin lesion
Clinical narrative: Local reaction left upper arm 7/23-7/30/2009. On 7/31/09 patient developed skin lesion right ankle and lower leg; clustered vesicles in annular shape and erythematous papules 8mm in size.
Age: 31.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pt noticed redness, swelling, tenderness at site of vaccine approx. 24 hours after receiving. Pt had slight itching at site, redness approx. 2" across.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Erythema, Feeling abnormal, Limb discomfort, Local reaction
Clinical narrative: Fever, feeling "off", dizziness, red local reaction, tender to touch (L arm).
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Tenderness
Clinical narrative: Fever, feeling "off", dizziness, red local reaction, tender to touch (L arm).
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cough, Oxygen saturation decreased, Radioallergosorbent test positive, Urticaria, Wheezing
Clinical narrative: Onset of coughing and hives within 3 minutes after shot given BENADRYL PO and EPI 0.1mg given SQ. Began having decreased (88%) and O2 applied; wheezing began and Albuterol 25mg/NS 3cc given. Second Epi 0.1mg SQ given and transported to ER by stretcher. Sent home from ED with Rx for Prednisolone 10mg every 12 hrs.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Dizziness, Heart rate decreased, Loss of consciousness, Pallor
Clinical narrative: Within 5 min of receiving HPV #3 in a semi-lying down position she started having some tremors and passed out. B/P at that time was 102/59 with a pulse of 49. She was pale around lips. She was more woozy then passed out. She was placed in flat supine position and given juice & crullers. She stayed supine for another 30 min. When she started to get up she fainted at that time. At that time her BP was 94/58, P = 40. She was observed over the next 30-35 min and her BP increased to 107/64 with P = 40. Color much better. She was observed over the next hour and a half with BP & P observed every 15 min. She was observed for 2 hrs since coming in with BP 112/68.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Tremor
Clinical narrative: Within 5 min of receiving HPV #3 in a semi-lying down position she started having some tremors and passed out. B/P at that time was 102/59 with a pulse of 49. She was pale around lips. She was more woozy then passed out. She was placed in flat supine position and given juice & crullers. She stayed supine for another 30 min. When she started to get up she fainted at that time. At that time her BP was 94/58, P = 40. She was observed over the next 30-35 min and her BP increased to 107/64 with P = 40. Color much better. She was observed over the next hour and a half with BP & P observed every 15 min. She was observed for 2 hrs since coming in with BP 112/68.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 1/2 upper arm on right side, swollen and red.
Age: 1.5
Sex: M
Vaccine: HEP
Symptoms: Hypersensitivity
Clinical narrative: Father of patient came to our office on 7-29-09. He stated that patient was given a vaccine in our office on 7-1-09 and he had to be taken to the emergency room due to an allergic reaction. Father did not have any documentation of the hospital visit.
Age: 20.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pt. came in 2/+ pain in L elbow on 8-4-09. Pt relates she had pain and swelling at injection site on 7-21-09 and now the pain and swelling at injection site on 7-21-09 and now the pain is in her elbow.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling and pain in R arm where vaccine was administered. Flu like symptoms w/o fever or chills.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Redness at injection site, pain at injection site, achy and tender to touch/hot to touch at injection site, itching/no fever or chills
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Hives
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Induration
Clinical narrative: 08/04/2009 MODERATE Other  INDURATION 3CMX 5CM/NO CELLULITIS
Age: 0.1
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV1
Symptoms: Crying, Irritability
Clinical narrative: Crying, fussy after the vaccines were given.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Fatigue, Rash
Clinical narrative: 07/23/2009 MODERATE Other.  FATIGUE RASH STARTING ON L EAR.  CONTINUING TO BE ON FACE AND MIDSECTION SAW PHYSICIAN ON 7/28.  (L) side of body only.
Age: 42.0
Sex: F
Vaccine: HEP, HEPA, IPV, TYP, YF
Symptoms: Blood test, Contusion, Dizziness, Headache, Pain
Clinical narrative: 7/10/09 Received vaccinations. 7/15/09 c/o aches/pains, dizziness, H/A bruise arm. No fever went to chiropractor 3 X after last 3 wks. 7/29/09 - Called our office with above complaints received eval by pcp ASAP.
Age: 54.0
Sex: F
Vaccine: IPV, YF
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: (R) upper arm was slightly swollen & pink surrounding site of injection (yellow fever).  C/o itching over body but no hives (Reported 7/31/09 - advised to check with her MD).
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Patient fainted after administration of Tdap (ADACEL) shot.
Age: 27.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Rash, Urticaria
Clinical narrative: Red rash/welts on inside portion of left upper arm, away from the injection site.
Age: 66.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: 6/23/09.  Itch developed and got worse not resolved with BENADRY tabs/cream.  Unable to go to MD.  7/1/09 Dr. - evaluated.  7/1/09 - Itching and hives up to shoulders (no facial, head or neck) started on PREDONISONE tapering dose and antihistamines & Hives were visible.  7/6/09 - PREDNISONE course completed.  Itching Med:  7/12/09 - Was restarted on PREDNISONE taping dose.  7/13/09 Dr.  - Dermatologist.  recommended to cancel all HEP B vaccine and informed her that reaction may be related to HEP B vaccine.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Urticaria
Clinical narrative: Pt with severe erythema localized & developed hives. No respiratory difficulty.
Age: 30.0
Sex: F
Vaccine: HEP, HEPA, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Developed VARICELLA Disease (chicken pox) Pox to left arm, stomach & legs.  rest, fluids, TYLENOL.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Skin warm
Clinical narrative: Redness, warm, 7 cm X 7 cm
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Skin warm
Clinical narrative: Right arm red and warm to touch.
Age: 9.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Received Hep A #1 and Varicella #2 1/26/09. Early AM, 1/27/09 parents noted m/p rash forehead. No vesicles, no fever, no redness. Resolved 14 days.
Age: 5.0
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Left arm with immediate itching and soon to follow redness, swelling & warmth.  BENADRYL given & Ibuprofen.  Seen in office on 8/3/09 for eval.  Mother concerned for component allergy.
Age: 0.7
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia, Screaming, Tremor
Clinical narrative: At 10 PM parents reported increased screaming;  fever 102 degrees with diff. reading temp.;  shaking;  taken to Hospital Dx vaccine reaction.
Age: 94.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Condition aggravated, Cough, Death, Hypertension, Hypoxia
Clinical narrative: Initial report received on 27 July 2009 from a literature citation. Purpose: To evaluate a possible association between influenza vaccination and four deaths and four serious illnesses among 114 recent influenza vaccinees in a long-term care facility (LTCF) and two deaths from a nearby physician's office. All had received vaccine from the same lot (Lot A). Methods Field investigation including (1) a retrospective cohort study among LTCF residents who received Lot A or other influenza vaccine, (2) review of medical records of cases of death or serious illness, (3) active surveillance of deaths among 1500 community based Lot A vaccinees and (4) laboratory testing of vaccine from available Lot A vials. Results Medical record reviews showed no common clinical syndrome or cause of death. Laboratory testing of Lot A samples revealed no evidence of tampering and no differences compared to an unrelated lot. The risk of death or hospitalization was not significantly different between persons who received Lot A versus a comparison lot, Lot B (incidence rate ratio (IRR) = 0.9, 95%CI = 0.3-3.3). Conclusions There was no clinical or biological evidence pointing to inherent vaccine safety issues, nor was there a detectable increased risk of death or hospitalization among persons vaccinated with Lot A. Lot specific clustering of adverse events (AEs) may reflect medical events causally unrelated to vaccination. Rapid investigations of potential AEs are important to ensure vaccine safety and to maintain public and healthcare provider confidence in vaccines. A 94 year old patient with a history of CVA, PVD, HTN, hypothyroidism, and partial gastrectomy received FLUZONE SV '2004-'2005 USP (lot number was not provided in article; however, lot number was entered according to the previous info received for the other 4 cases, U1478AA) on an unspecified date. Five days post vaccination, the patient developed a cough. Eighteen days post vaccination the patient died. According to the death certificate, causes of death were respiratory depression, hypoxia, and hypertension. Date of death was not provided. Four additional cases were mentioned in this article that was previously reported to the Company: 2004-03646, 2004-03647, 2004-03648, and 2004-03649.