chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Myelitis transverse, Pain, Pyrexia, Skin ulcer
Clinical narrative: Previously healthy patient was admitted to hospital 10/22-10/23/03 and diagnosed with asthma and viral respiratory illness. Prior to discharge, influenza vaccine 0.5 mL was administered IM in left upper arm. Two days later family members noticed patient limping and c/o left lower extremity pain. Pain/inability to move LLE continued at home. Patient was readmitted 10/28/03 with diagnosis "transverse myelitis vs. atypical Guillan-Barre."  MRI showed demyelinating lesion in lumbar spine. While hospitalized 10/28/03 to 12/3/03, patient received intravenous immune globulin, intravenous steroids, azithromycin and multiple other medications. During hospitalization family expressed concern about a possible speech/hearing problem but audiology consult revealed normal hearing in one hear, unable to assess other ear due to patient not cooperative. Patient required physicial therapy and brace to assist walking. Discharged to home 12/3/03 with plans to continue physical therapy.  Nurse follow up on 08/04/04 states: "spasm." Discharge summary states fever. msv
Age: 7.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia, Rash, Upper respiratory tract infection
Clinical narrative: Mother states child had mild cold with no fever at time of vaccination. Mother states child started with a fever of 102F on 1/27/04 at 12am. Saw pediatrician on 1/30/04. Pediatrician diagnosed child with upper respiratory infection. Child given 5 day perscription of Zithromax. Mother states did not mention to MD that child had immunizations on 1/26/04.  Fever gone as of 2/2/04, but rash on back and abdomen started that day. On 2/3/04, rash gone and child recovered. Rash did not require MD visit.  Note: This was child's first immunization using Pediarix, but child did have 2 previous doses of DTaP, 2 previous doses of IPV, and 2 previous doses of Hepatitis B. Child also has had 1 previous dose of Hib, but was given as Comvax previously. Child has had no prior reactions to any vaccinations.
Age: 32.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Laboratory test abnormal, Myocarditis, Pleuritic pain
Clinical narrative: Probable myocarditis, based on cardiac enzyme elevation and pleuritic chest pain approx. 15 days post-vaccination.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Alopecia, Depression, Eye pain, Fatigue, Headache
Clinical narrative: Hair Loss enough to scare the hell out of me. Fatigue,headaches eye pain, depression, muscle spasams and tension. vaccinated around 1989, just realized the connection recently.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Muscle spasms
Clinical narrative: Hair Loss enough to scare the hell out of me. Fatigue,headaches eye pain, depression, muscle spasams and tension. vaccinated around 1989, just realized the connection recently.
Age: 28.0
Sex: M
Vaccine: ANTH, YF
Symptoms: Erythema, Injection site warmth, Tenderness
Clinical narrative: Localized erythemic patch approximately 10 x 12 cm with well defined borders. Tender to palpation at left upper extremity mid-bicep. Site is also hot to the touch.  Tx: Keflex #40 Sig: Take 1Tab PO QID x 10 days. Finish all medication
Age: 18.0
Sex: F
Vaccine: ANTH
Symptoms: Hypersensitivity, Rash
Clinical narrative: Generalized rash to entire body.  Seen in Emergency Department.  Seen in Clinic. Given Medrol 4MG Taper Pack and Benadryl
Age: 0.4
Sex: M
Vaccine: DTAP
Symptoms: Red blood cell abnormality, Screaming
Clinical narrative: High pitched crying-continuous!  Very hard to settle down.  (2nd form i've sent in on this, never received one back from you.)
Age: 34.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Dyspnoea, Headache, Laboratory test abnormal, Myocardial infarction
Clinical narrative: Day 3 post immunization developed tingling in fingers 6 days post immunization developed severe headache and mild SOB on exertion About 30 days post immunization developed severe headace, slight chest pain At 5 months and 3 weeks post immunization had an anterior myocardial infarct.
Age: 34.0
Sex: M
Vaccine: SMALL
Symptoms: Paraesthesia
Clinical narrative: Day 3 post immunization developed tingling in fingers 6 days post immunization developed severe headache and mild SOB on exertion About 30 days post immunization developed severe headace, slight chest pain At 5 months and 3 weeks post immunization had an anterior myocardial infarct.
Age: 1.3
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Neoplasm, Nervous system disorder, Pulmonary congestion, Pulmonary oedema, Unevaluable event
Clinical narrative: Information regarding Prevnar was received from an investigator regarding a 16 month old female participant in the Prevnar Post-Marketing Safety Surveillance Trial, "Post-Marketing Evaluation of Prevnar Pneumococcal 7-Valent Conjugate vaccine: Safety of Prevnar Administered Concurrently with Routine Infant Vaccinations at 2, 4, 6, and 12 to 15 Months of Age," who died as a result of SIDS-like syndrome. The child received the third dose on 5/20/02, at 6 months of age. On 4/10/03, the pt experienced SIDS-like syndrome. The reporter indicated that the "coroner's report (pending paperwork) states the cause of death is not explainable due to findings; too old for SIDS." No additional info was available at the time of this report. Both the investigator and the medical monitor assessed the SIDS as "not related" to the study vaccine. No additional info was available at the date of this report. Follow Up: On 10APR2003, at approximatley 1530 hours to 1545 hours, the child was found unresponsive by a day care worker. The 911 system was activated and the paramedics responded. The child was taken to an emergency room; efforts to resuscitate her failed. At 1642, she was pronounced dead. The coronoer's reported cause of death was "not explainable due to findings; too old for SIDS." On 11Apr2003, at approximately 1530 hours to 1545 hours, the child was found unresponsive by a day care worker. The 911 system was activated and the paramedics responded. The child was taken to an emergency room; efforts to resuscitate her failed. At 1642, she was pronounced dead. The coroner's reported cause of death was "not explainable due to findings; too old for SIDS." On 11APR2003, an autopsy was performed; the results revealed a clinical hisotry of listlessness and tirednes. The autopsy anatomical diagnoses included "cerebral flattening, pulmonary edema and congestion, no congenital anomalies, and a healing fracture of right clavicle." The coroner's autopsy reported cause of death was reported as "anatomic and toxicologic findings insufficient to explain death in a child with a healing fracture of right clavicle." The investigator indicated that the cause of death was "SIDS-like syndrome."
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, IPV, IPV, HEP, IPV, DTAP
Symptoms: Sudden infant death syndrome
Clinical narrative: This report of SIDS is being submitted in an expedited time frame as requested by the FDA. Information regarding Prevnar was received from an investigator regarding a 2 month old female participant in a post marketing evaluation of Prevnar. The child received the first dose on 11/28/00, at 2 months of age. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 11/28/00. Dose regimen was 1 dose. Concomitant therapy included Hib-Titer, Infanrix vaccine, IPOL, vaccine, and Recombivax HB vaccine. On 12/1/00, four days post immunization, the patient experienced SIDS. According to the coroner's office, the cause of death was reported as SIDS. Both the investigator and the medical monitor assessed the SIDS as remotely possibly related  to the study vaccine. On 2/2/04, additional documentation regarding this event has been requested by the investigator. Additional information received on 11-Feb-2004 provide autopysy results. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm 197 protein) Injection) was received from an investigator regarding a 2 month old female participant in a surveillance trial. Safter of Prevnar administered concurrently with routing infant vaccinations at 2, 4, 6 and 12 to 15 months of age who died as a result of an unexpected sudden death. The child received the first dose on 28-Nov-2003, at 2 months of age.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, IPV, IPV, HEP, IPV, DTAP
Symptoms: Unevaluable event
Clinical narrative: This report of SIDS is being submitted in an expedited time frame as requested by the FDA. Information regarding Prevnar was received from an investigator regarding a 2 month old female participant in a post marketing evaluation of Prevnar. The child received the first dose on 11/28/00, at 2 months of age. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 11/28/00. Dose regimen was 1 dose. Concomitant therapy included Hib-Titer, Infanrix vaccine, IPOL, vaccine, and Recombivax HB vaccine. On 12/1/00, four days post immunization, the patient experienced SIDS. According to the coroner's office, the cause of death was reported as SIDS. Both the investigator and the medical monitor assessed the SIDS as remotely possibly related  to the study vaccine. On 2/2/04, additional documentation regarding this event has been requested by the investigator. Additional information received on 11-Feb-2004 provide autopysy results. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm 197 protein) Injection) was received from an investigator regarding a 2 month old female participant in a surveillance trial. Safter of Prevnar administered concurrently with routing infant vaccinations at 2, 4, 6 and 12 to 15 months of age who died as a result of an unexpected sudden death. The child received the first dose on 28-Nov-2003, at 2 months of age.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, IPV, IPV, HEP, IPV, DTAP
Symptoms: Pulmonary congestion, Pulmonary oedema, Sudden infant death syndrome
Clinical narrative: This report of SIDS is being submitted in an expedited time frame as requested by the FDA. Information regarding Prevnar was received from an investigator regarding a 2 month old female participant in a post marketing evaluation of Prevnar. The child received the first dose on 11/28/00, at 2 months of age. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 11/28/00. Dose regimen was 1 dose. Concomitant therapy included Hib-Titer, Infanrix vaccine, IPOL, vaccine, and Recombivax HB vaccine. On 12/1/00, four days post immunization, the patient experienced SIDS. According to the coroner's office, the cause of death was reported as SIDS. Both the investigator and the medical monitor assessed the SIDS as remotely possibly related  to the study vaccine. On 2/2/04, additional documentation regarding this event has been requested by the investigator. Additional information received on 11-Feb-2004 provide autopysy results. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm 197 protein) Injection) was received from an investigator regarding a 2 month old female participant in a surveillance trial. Safter of Prevnar administered concurrently with routing infant vaccinations at 2, 4, 6 and 12 to 15 months of age who died as a result of an unexpected sudden death. The child received the first dose on 28-Nov-2003, at 2 months of age.
Age: 0.3
Sex: F
Vaccine: DTAPH, IPV, PNC
Symptoms: Coma, Pathological fracture, Petechiae, Sudden infant death syndrome
Clinical narrative: this report of SIDS is being submitted in an expedited time frame as requested by the FDA. Information regarding Prevnar was received from an investigator regarding a 4 month old female participant in a post-marketing safety surveillance trial who died as a result of SIDS. The child received the second dose on 2/3/03. The baby had no medical history. The mother reported her child had been sick recently with diarrhea and vomiting. Indication for Prevnar was immunization. Product was administered on 2/3/03. Dose regimen was 1 dose. Concomitant therapy included Pentacel. On 2/7/03, 4 days post immunization, at approximately 0920 hours, the child was found unresponsive. Emergency services was called and emergency personnel responded and started life saving measures. The child was transported to a hospital and life saving measures were continued. The child was pronounced dead on 2/7/03 at approximately 0945 hours. On 2/10/03, an autopsy was performed and revealed petechiae on the thymus. The autopsy reported the cause of death as SIDS. On 2/10/03, toxicologic test results revealed no common acidic, neutral or basic drugs were detected; no blood ethyl alcohol or other alcohols or acetone were detected; and no analgesics or barbiturates were detected by specific drug assay. The cause of death was reported as provisional SIDS and the autopsy cause of death was sudden infant death syndrome. Both the investigator and the medical monitor assessed the SIDS as remotely possibly related to the study vaccine. No additional information was available at the date of this report. The autopsy report received on 2/26/04 states healing fx of clavicle.
Age: 49.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Hyperhidrosis, Myocardial infarction
Clinical narrative: Burning chest pain began late evening 1/31/04 and went away for 12hr and recurred on 2/1/04. Sweating. Went to ER-angioplasty and stent inferior MI.
Age: 44.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain
Clinical narrative: Chest pain developed approximately 3 days after receiving vaccination. ER assessment-no fever, no evidence of myocardial infarction.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Abdominal pain, Amnesia, Arthralgia, Diverticulitis, Haemorrhoids
Clinical narrative: Irritable bowel vs inflammatory bowel syndrome with hematochegia.  In July 2000 the fatigue, abdominal pain and rectal bleeding increased.  He also developed myalgias in the legs, back and shoulders. Headaches began in Dec 00.  By Jan 01, he was no longer able to perform physical training.  After exertion he reports having increased pain and rectal bleeding for up to 3 days.  In 2000 and 2001 he underwent a 2nd GI workup.  Results of testing are below.  In July 03 he received a Medical Board.  It found him fit for full duty.  Current problem list: Abdominal pain and Hematochezia, muscle and joint pain, headaches, short term memory loss, Insomnia, "grey-out" episodes.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Insomnia, Laboratory test abnormal, Myalgia, Pain
Clinical narrative: Irritable bowel vs inflammatory bowel syndrome with hematochegia.  In July 2000 the fatigue, abdominal pain and rectal bleeding increased.  He also developed myalgias in the legs, back and shoulders. Headaches began in Dec 00.  By Jan 01, he was no longer able to perform physical training.  After exertion he reports having increased pain and rectal bleeding for up to 3 days.  In 2000 and 2001 he underwent a 2nd GI workup.  Results of testing are below.  In July 03 he received a Medical Board.  It found him fit for full duty.  Current problem list: Abdominal pain and Hematochezia, muscle and joint pain, headaches, short term memory loss, Insomnia, "grey-out" episodes.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Rectal haemorrhage
Clinical narrative: Irritable bowel vs inflammatory bowel syndrome with hematochegia.  In July 2000 the fatigue, abdominal pain and rectal bleeding increased.  He also developed myalgias in the legs, back and shoulders. Headaches began in Dec 00.  By Jan 01, he was no longer able to perform physical training.  After exertion he reports having increased pain and rectal bleeding for up to 3 days.  In 2000 and 2001 he underwent a 2nd GI workup.  Results of testing are below.  In July 03 he received a Medical Board.  It found him fit for full duty.  Current problem list: Abdominal pain and Hematochezia, muscle and joint pain, headaches, short term memory loss, Insomnia, "grey-out" episodes.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site mass, Injection site oedema, Injection site pain, Nausea
Clinical narrative: Nauseated afterwards till night.  Flu-left arm, softball size swelling, went down next day but has stayed sore.  Pneumonia-right arm: knot and still very sore.  Prednisone to treat left arm and augmentin right arm.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site oedema, Rash
Clinical narrative: Right arm where vaccine was given was swollen to elbow and chest.  Cellulitis type rash on area. Symptoms subsided after treatment with Prednisone and Atarax and Augmentin.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Asthenia
Clinical narrative: Severe joint pain in knuckles of left hand and minor joint pain in left elbow.  Loss of strength and manual dexterity in hand due to pain.  Pain began within week of shot and is starting to subside 2.5 months later.
Age: 47.0
Sex: M
Vaccine: ANTH
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Pain in shoulders and wrist right.  Decreased range of motion, the 3rd shot on 04/01/03.
Age: 1.0
Sex: F
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Rash maculo-papular, Viral infection
Clinical narrative: Viral illness with maculopapular rash
Age: 65.0
Sex: M
Vaccine: LYME
Symptoms: Asthenia, Balance disorder
Clinical narrative: Winter of 2000, balance problems. Spring 2001, treated for inter ear, no help! Vallance, weakness legs and arms-2003, treated with Docephin not enough.  02/04: Starting on Cefuroxine and Zithromax
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Joint swelling, Urticaria
Clinical narrative: Swollen joints, rash=hives
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administration error
Clinical narrative: Administered adult dose of Hepatitis A instead of Pedatric
Age: 1.4
Sex: U
Vaccine: IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Left upper thigh 1.5cm in diameter, erythematous circular area with 0.5cm indurated area in the center.  No vesicles, no other lesions.
Age: 1.5
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Left upper thigh, 1.5in diameter erythematous circular area with 0.5cm indurated area in the center.  No vesicles, no other lesions.
Age: 4.0
Sex: F
Vaccine: HIBV, VARCEL
Symptoms: Nausea, Pyrexia, Rash vesicular, Skin ulcer
Clinical narrative: Mom reports after vaccine given the pt developed a fever of 100-101 degrees. Also developed "pox" lesions on back and was nauseous for 2 weeks.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine DTAP on 02/09/04 was given on deltoid (right).  Raised, warm, indurated area 5-6 hours. Cellulitis with 2 hours.  Warm compress, antibiotics used to help cellulitis get better.
Age: 25.0
Sex: M
Vaccine: HEP
Symptoms: Facial palsy, Speech disorder
Clinical narrative: Pt resides in prison.  Received vaccine due to possible work rash (OSHA).  Vaccinated 12/11/03 @ 08:30.  Reports that on 12/26/03 woke up and was unable to move left side of face and blurred speech. Came to prison ER 12/31/03 with diagnosis of Bells Palsy.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Cough, Rhinorrhoea, Urticaria
Clinical narrative: Prevnar, daptacel, acthib, ipv on 01/30/04.  Hives on 01/31.  Hives gone by 02/03.  No fever or illness symptoms no irritability.  Cough and runny nose developed 02/07.  No treatment.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Urticaria
Clinical narrative: Prevnar, daptacel, acthib, ipv on 01/30/04.  Hives on 01/31.  Hives gone by 02/03.  No fever or illness symptoms no irritability.  Cough and runny nose developed 02/07.  No treatment.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Adverse reaction: swelling, erythema, induration to right upper extremity at site of injection surrounding area down to anteabitol fossa.  Reaction noticed 11pm on day injections given.  02/10/04: no change today.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Pt developed local redness and swelling to right thigh following immunization on 02/09/04.  Swelling and redness increased to include entire thigh.
Age: 4.58
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Feeling hot, Pruritus, Swelling
Clinical narrative: Red, swollen, hot, itchy. Treatment-warm, compresses, Motrin.
Age: 63.0
Sex: M
Vaccine: YF, YF, HEP, HEPA, TYP
Symptoms: Anorexia, Back pain, Blood bilirubin increased, Chills, Delirium
Clinical narrative: On 2/2/04 had vomiting, chills, fever, dizziness, hemoptysis, lower back pain, and HA, and possible delirium. On 2/3/04 began to develop jaundice. Had loss of appetite and lost about 9 lbs in 3-4 days. Went to an ER on 2/4/04 and was hospitalized for 4 days. In the hospital, had a sputum culture that grew strep pneumonia. Also had high bilirubin. Also developed a macular papular rash on the rt side of the back.  The resident caring for the pateint stated the diagnosis was strep pneumonia and also yellow fever vaccine reaction. Resident stated the strep pneumonia was not the cause of the jaundice and liver problem. The pateint had had a head cold and cough for about 2 weeks prior to the YF vaccine receipt.
Age: 63.0
Sex: M
Vaccine: YF, YF, HEP, HEPA, TYP
Symptoms: Dizziness, Haemoptysis, Headache, Jaundice, Pyrexia
Clinical narrative: On 2/2/04 had vomiting, chills, fever, dizziness, hemoptysis, lower back pain, and HA, and possible delirium. On 2/3/04 began to develop jaundice. Had loss of appetite and lost about 9 lbs in 3-4 days. Went to an ER on 2/4/04 and was hospitalized for 4 days. In the hospital, had a sputum culture that grew strep pneumonia. Also had high bilirubin. Also developed a macular papular rash on the rt side of the back.  The resident caring for the pateint stated the diagnosis was strep pneumonia and also yellow fever vaccine reaction. Resident stated the strep pneumonia was not the cause of the jaundice and liver problem. The pateint had had a head cold and cough for about 2 weeks prior to the YF vaccine receipt.
Age: 63.0
Sex: M
Vaccine: YF, YF, HEP, HEPA, TYP
Symptoms: Rash maculo-papular, Sepsis, Vomiting, Weight decreased
Clinical narrative: On 2/2/04 had vomiting, chills, fever, dizziness, hemoptysis, lower back pain, and HA, and possible delirium. On 2/3/04 began to develop jaundice. Had loss of appetite and lost about 9 lbs in 3-4 days. Went to an ER on 2/4/04 and was hospitalized for 4 days. In the hospital, had a sputum culture that grew strep pneumonia. Also had high bilirubin. Also developed a macular papular rash on the rt side of the back.  The resident caring for the pateint stated the diagnosis was strep pneumonia and also yellow fever vaccine reaction. Resident stated the strep pneumonia was not the cause of the jaundice and liver problem. The pateint had had a head cold and cough for about 2 weeks prior to the YF vaccine receipt.
Age: 63.0
Sex: M
Vaccine: YF, YF, HEP, HEPA, TYP
Symptoms: Abdominal pain, Anorexia, Back pain, Bacterial infection, Chest pain
Clinical narrative: On 2/2/04 had vomiting, chills, fever, dizziness, hemoptysis, lower back pain, and HA, and possible delirium. On 2/3/04 began to develop jaundice. Had loss of appetite and lost about 9 lbs in 3-4 days. Went to an ER on 2/4/04 and was hospitalized for 4 days. In the hospital, had a sputum culture that grew strep pneumonia. Also had high bilirubin. Also developed a macular papular rash on the rt side of the back.  The resident caring for the pateint stated the diagnosis was strep pneumonia and also yellow fever vaccine reaction. Resident stated the strep pneumonia was not the cause of the jaundice and liver problem. The pateint had had a head cold and cough for about 2 weeks prior to the YF vaccine receipt.
Age: 63.0
Sex: M
Vaccine: YF, YF, HEP, HEPA, TYP
Symptoms: Chills, Delirium, Dizziness, Drug ineffective, Headache
Clinical narrative: On 2/2/04 had vomiting, chills, fever, dizziness, hemoptysis, lower back pain, and HA, and possible delirium. On 2/3/04 began to develop jaundice. Had loss of appetite and lost about 9 lbs in 3-4 days. Went to an ER on 2/4/04 and was hospitalized for 4 days. In the hospital, had a sputum culture that grew strep pneumonia. Also had high bilirubin. Also developed a macular papular rash on the rt side of the back.  The resident caring for the pateint stated the diagnosis was strep pneumonia and also yellow fever vaccine reaction. Resident stated the strep pneumonia was not the cause of the jaundice and liver problem. The pateint had had a head cold and cough for about 2 weeks prior to the YF vaccine receipt.
Age: 63.0
Sex: M
Vaccine: YF, YF, HEP, HEPA, TYP
Symptoms: Jaundice, Laboratory test abnormal, Pyrexia, Rash maculo-papular, Vomiting
Clinical narrative: On 2/2/04 had vomiting, chills, fever, dizziness, hemoptysis, lower back pain, and HA, and possible delirium. On 2/3/04 began to develop jaundice. Had loss of appetite and lost about 9 lbs in 3-4 days. Went to an ER on 2/4/04 and was hospitalized for 4 days. In the hospital, had a sputum culture that grew strep pneumonia. Also had high bilirubin. Also developed a macular papular rash on the rt side of the back.  The resident caring for the pateint stated the diagnosis was strep pneumonia and also yellow fever vaccine reaction. Resident stated the strep pneumonia was not the cause of the jaundice and liver problem. The pateint had had a head cold and cough for about 2 weeks prior to the YF vaccine receipt.
Age: 63.0
Sex: M
Vaccine: YF, YF, HEP, HEPA, TYP
Symptoms: Weight decreased
Clinical narrative: On 2/2/04 had vomiting, chills, fever, dizziness, hemoptysis, lower back pain, and HA, and possible delirium. On 2/3/04 began to develop jaundice. Had loss of appetite and lost about 9 lbs in 3-4 days. Went to an ER on 2/4/04 and was hospitalized for 4 days. In the hospital, had a sputum culture that grew strep pneumonia. Also had high bilirubin. Also developed a macular papular rash on the rt side of the back.  The resident caring for the pateint stated the diagnosis was strep pneumonia and also yellow fever vaccine reaction. Resident stated the strep pneumonia was not the cause of the jaundice and liver problem. The pateint had had a head cold and cough for about 2 weeks prior to the YF vaccine receipt.
Age: 63.0
Sex: M
Vaccine: YF, YF, HEP, HEPA, TYP
Symptoms: Abdominal pain, Anorexia, Back pain, Bacterial infection, Blood bilirubin increased
Clinical narrative: On 2/2/04 had vomiting, chills, fever, dizziness, hemoptysis, lower back pain, and HA, and possible delirium. On 2/3/04 began to develop jaundice. Had loss of appetite and lost about 9 lbs in 3-4 days. Went to an ER on 2/4/04 and was hospitalized for 4 days. In the hospital, had a sputum culture that grew strep pneumonia. Also had high bilirubin. Also developed a macular papular rash on the rt side of the back.  The resident caring for the pateint stated the diagnosis was strep pneumonia and also yellow fever vaccine reaction. Resident stated the strep pneumonia was not the cause of the jaundice and liver problem. The pateint had had a head cold and cough for about 2 weeks prior to the YF vaccine receipt.
Age: 63.0
Sex: M
Vaccine: YF, YF, HEP, HEPA, TYP
Symptoms: Chest pain, Chills, Delirium, Dizziness, Haemoptysis
Clinical narrative: On 2/2/04 had vomiting, chills, fever, dizziness, hemoptysis, lower back pain, and HA, and possible delirium. On 2/3/04 began to develop jaundice. Had loss of appetite and lost about 9 lbs in 3-4 days. Went to an ER on 2/4/04 and was hospitalized for 4 days. In the hospital, had a sputum culture that grew strep pneumonia. Also had high bilirubin. Also developed a macular papular rash on the rt side of the back.  The resident caring for the pateint stated the diagnosis was strep pneumonia and also yellow fever vaccine reaction. Resident stated the strep pneumonia was not the cause of the jaundice and liver problem. The pateint had had a head cold and cough for about 2 weeks prior to the YF vaccine receipt.
Age: 63.0
Sex: M
Vaccine: YF, YF, HEP, HEPA, TYP
Symptoms: Headache, Hypersensitivity, Jaundice, Laboratory test abnormal, Pneumonia
Clinical narrative: On 2/2/04 had vomiting, chills, fever, dizziness, hemoptysis, lower back pain, and HA, and possible delirium. On 2/3/04 began to develop jaundice. Had loss of appetite and lost about 9 lbs in 3-4 days. Went to an ER on 2/4/04 and was hospitalized for 4 days. In the hospital, had a sputum culture that grew strep pneumonia. Also had high bilirubin. Also developed a macular papular rash on the rt side of the back.  The resident caring for the pateint stated the diagnosis was strep pneumonia and also yellow fever vaccine reaction. Resident stated the strep pneumonia was not the cause of the jaundice and liver problem. The pateint had had a head cold and cough for about 2 weeks prior to the YF vaccine receipt.
Age: 63.0
Sex: M
Vaccine: YF, YF, HEP, HEPA, TYP
Symptoms: Pyrexia, Rash maculo-papular, Vomiting, Weight decreased
Clinical narrative: On 2/2/04 had vomiting, chills, fever, dizziness, hemoptysis, lower back pain, and HA, and possible delirium. On 2/3/04 began to develop jaundice. Had loss of appetite and lost about 9 lbs in 3-4 days. Went to an ER on 2/4/04 and was hospitalized for 4 days. In the hospital, had a sputum culture that grew strep pneumonia. Also had high bilirubin. Also developed a macular papular rash on the rt side of the back.  The resident caring for the pateint stated the diagnosis was strep pneumonia and also yellow fever vaccine reaction. Resident stated the strep pneumonia was not the cause of the jaundice and liver problem. The pateint had had a head cold and cough for about 2 weeks prior to the YF vaccine receipt.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Dizziness, Headache, Hypotonic urinary bladder, Nausea, Pruritus
Clinical narrative: Patient is 33-year-old male s/p Anthrax vaccination on the 10th of February who presents with a large local reaction.  He complains of swelling that occurred within 12 hours of the injection.  He feels that since that time the swelling has been pretty persistent with no significant increase in the amount of swelling but has not resolved either.  He also complained of headaches and weakness that was noted about 6 hours after the vaccination.  He took 400 mg of motrin with improvement of his symptoms.  He denies any vomiting but felt some nausea at the time.  No fevers or chills.  No joint aches.  By the next morning the weakness and dizziness was gone but the swelling was noticed.  The swelling is a little itchy but not generally painful.  No weakness in hands or arms.
Age: 0.0
Sex: M
Vaccine: ANTH
Symptoms: Abscess, Bacterial infection, Cyst, Dermatitis acneiform, Groin pain
Clinical narrative: This is a 38 year-old who presents for evaluation prior adverse event to receipt of his first two anthrax vaccinations. The client relates that he received his 1st anthrax vaccination on or about 01/16/2003. Within a day or two of receiving the vaccination, the client developed a "white pimply, itchy" rash behind his left knee. Since he has a known history of eczema, the client treated it initially as he would his eczema. He applied Eucerin cream and later was provided with hydrocortisone cream. He relates that the area seemed to clear up, but remained itchy.  Approximately 2 weeks after receiving the first anthrax vaccination, the client received his second vaccination per the accepted schedule. Later the same day he was deployed. He developed a "white pimply, itchy" rash in his groin and scrotal area approximately 3 days following receipt of the 2nd vaccination. He was initially treated for tinea corpus (jock itch), but this did nothing to cure the problem. He reported back to medical on 16 February 2003 with complaints of a 5-day episode of left testicular pain and swelling. He relates that his pain on standing was 8-10/10 and while sitting was 5-6/10. It was determined that he did not have tinea corpus and he was admitted to the hospital for further evaluation and treatment. He underwent a diagnostic ultrasound that demonstrated left testicle intact without masses, epididymal cyst with fluid and scrotal wall edema. His WBC count was 10.8, with the remainder of the complete blood count within normal limits. His urinalysis was also within normal limits.  On 19 February, the client underwent incision and drainage of penile base, left hemi-scrotal secondary to abscess formation. He was treated with multiple antibiotics, both for anaerobic and aerobic organisms. He progressed satisfactorily and on 26 Feb 2003, he was medivaced to another hospital. Sometime thereafter, the date is not listed in the chart, the client was returned to continue convalescence.  Nurse follow up on 08/31/04 states: "Confirmed scrotal abscess; fever; rash."
Age: 0.0
Sex: M
Vaccine: ANTH
Symptoms: Pruritus, Pyrexia, Rash, Scrotal pain, Swelling
Clinical narrative: This is a 38 year-old who presents for evaluation prior adverse event to receipt of his first two anthrax vaccinations. The client relates that he received his 1st anthrax vaccination on or about 01/16/2003. Within a day or two of receiving the vaccination, the client developed a "white pimply, itchy" rash behind his left knee. Since he has a known history of eczema, the client treated it initially as he would his eczema. He applied Eucerin cream and later was provided with hydrocortisone cream. He relates that the area seemed to clear up, but remained itchy.  Approximately 2 weeks after receiving the first anthrax vaccination, the client received his second vaccination per the accepted schedule. Later the same day he was deployed. He developed a "white pimply, itchy" rash in his groin and scrotal area approximately 3 days following receipt of the 2nd vaccination. He was initially treated for tinea corpus (jock itch), but this did nothing to cure the problem. He reported back to medical on 16 February 2003 with complaints of a 5-day episode of left testicular pain and swelling. He relates that his pain on standing was 8-10/10 and while sitting was 5-6/10. It was determined that he did not have tinea corpus and he was admitted to the hospital for further evaluation and treatment. He underwent a diagnostic ultrasound that demonstrated left testicle intact without masses, epididymal cyst with fluid and scrotal wall edema. His WBC count was 10.8, with the remainder of the complete blood count within normal limits. His urinalysis was also within normal limits.  On 19 February, the client underwent incision and drainage of penile base, left hemi-scrotal secondary to abscess formation. He was treated with multiple antibiotics, both for anaerobic and aerobic organisms. He progressed satisfactorily and on 26 Feb 2003, he was medivaced to another hospital. Sometime thereafter, the date is not listed in the chart, the client was returned to continue convalescence.  Nurse follow up on 08/31/04 states: "Confirmed scrotal abscess; fever; rash."
Age: 24.0
Sex: F
Vaccine: TD
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Immediately following vaccination pt experienced pain in left upper arm. Pain most severe first 3 days after vaccine, then diminished to a chronic ache which is constant since then.  Saw physician 2-5-04, x-ray showed no abnormality.  Took Ibuprofen 400 mg TID with some relief. Saw MD again 2-12-04 and reports pain recurs without Ibuprofen.  Plan physical therapy appt for evaluation.
Age: 49.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Rash
Clinical narrative: Rash developed on both forearms, groin areas and thighs bilaterally. We suggested that he take Claritin, which he did for 2 days, then rash was completely gone.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site swelling
Clinical narrative: PATIENT ARRIVES TO  EMERGENCY ROOM ON FEBRUARY 5, 2004 AT 1822.  PATIENT HAS SWELLING OF RIGHT ARM AROUND SMALLPOX VACCINATION SITE.
Age: 74.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Feeling hot, Pain, Swelling
Clinical narrative: Received vaccine on 12/29/03.  On 12/31/03 AM noticed swelling, redness.  Since then, increased swelling, redness, warm to the touch and now painful.  No breathing problems or swelling with throat or mouth.
Age: 51.0
Sex: F
Vaccine: DT
Symptoms: Chills, Dizziness, Dyspnoea, Fatigue, Headache
Clinical narrative: Within one hour after shot was given, I was tired, achy body, chills, crabby, had shortness of breath, the next morning, I felt dizzy, sick to my stomach, head ache, body ached all over, and my head felt funny. This was after I received  hte Tetanus & Diphtheria Vaccine shot.  The lot number will be provided to you when I hear back from the Dr's office. including the Mfg. name.
Age: 51.0
Sex: F
Vaccine: DT
Symptoms: Irritability, Nausea, Pain
Clinical narrative: Within one hour after shot was given, I was tired, achy body, chills, crabby, had shortness of breath, the next morning, I felt dizzy, sick to my stomach, head ache, body ached all over, and my head felt funny. This was after I received  hte Tetanus & Diphtheria Vaccine shot.  The lot number will be provided to you when I hear back from the Dr's office. including the Mfg. name.
Age: 1.5
Sex: M
Vaccine: DTAP, FLUX, HIBV, MMR, PNC, VARCEL
Symptoms: Agitation, Conjunctivitis, Febrile convulsion, Hypertonia, Lethargy
Clinical narrative: Pt. presented to ER at 8pm 2/5/04 after having received 6 immunizations earlier same day.  Child was having febrile seizures.  CBC done @ hospital with other tests done.  No medication given/prescribed. Child appeared to be OK  at PE 2/6/04. Medical record received on 3/23/04 states body ridged, arms shaking, lethargic, fussy, viral illness, emesis and eye infected.
Age: 1.5
Sex: M
Vaccine: DTAP, FLUX, HIBV, MMR, PNC, VARCEL
Symptoms: Tremor, Viral infection, Vomiting
Clinical narrative: Pt. presented to ER at 8pm 2/5/04 after having received 6 immunizations earlier same day.  Child was having febrile seizures.  CBC done @ hospital with other tests done.  No medication given/prescribed. Child appeared to be OK  at PE 2/6/04. Medical record received on 3/23/04 states body ridged, arms shaking, lethargic, fussy, viral illness, emesis and eye infected.
Age: 2.0
Sex: F
Vaccine: DTAP, HBHEPB, MMR
Symptoms: Arthritis
Clinical narrative: juvenile arthritis onset with immunizations
Age: 1.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR, PNC, VARCEL
Symptoms: Anaphylactic reaction, Erythema, Eye oedema, Urticaria, Wheezing
Clinical narrative: hives head to toe,wheezing,eyes swelling shut,0.1mg Epi given SQ,1 teas. benadryl,0.5cc NS albuteral nebulizer-20 mins. 0.63 xopenex nebulizer still has hives,redness, swelling decreasing, child playful,sent home after 2 hrs. 2/6/04 f/u-still some swelling, treating with benadryl at home.Rec:allergy testing. The medical record received on 2/19/04 states anaphylaxis.
Age: 5.0
Sex: M
Vaccine: DTAP, HBHEPB, HEPA, IPV, MMR, PPV
Symptoms: Abasia, Erythema, Feeling hot, Pain, Swelling
Clinical narrative: Onset of redness left anterioe thigh noted by foster mom early 02/12/04. Ibuprofen given.  Redness faded to mildly pink and swelling increased.He refused to walk on leg and complains of pain when it is touched.  Examined in office.  Afebrile, talkative, alert and cooperative. Mildly pink edematous  anterior left thigh, mildy warm to touch and painful to touch.  No induration.  Treatment plan: continue p.o. ibuprofen, use warm moist packs to area for 15 minutes 3-4 times per day, gradually place more weight on leg.  Return to clinic or seek emergent care if fever, severe redness and hot to touch, if area becomes hard to touch, if area develops soft/fluctuant area in center, if left groin lymph nodes become enlarged.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Pt brought to pediatric clinic on 09/05/03 for redness, tenderness and swelling to left arm.  Keflex prescribed every 6 hours for 1 week.  Cool compresses to site, Tylenol as needed for pain or if fever develops.  Pt to follow up in urgent care in 3 days.
Sex: M
Vaccine: HEP
Symptoms: Arrhythmia, Asthenia, Blood glucose increased, Circulatory collapse, Cold sweat
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site reaction in a male pt in his fifties who received hep B vaccine recombinant (Engerix B). Medical history included diabetes, and the pt was described as "rather large." On 1/27/04 the pt received Engerix B (5465A6). At the time of vaccination, the pt experienced an injection site reaction characterized by injection site pain. While walking from the examination room, the pt complained of weakness and subsequently collapsed. The pt was moved by wheelchair to an examination room, where his blood sugar level was 199. A blood pressure was not taken because a blood pressure cuff could not be placed on the pt's arm. The pt developed a "pulse of 52 and skipping," pallor, sweating, SOB, coolness to touch, and nausea. He was transported by ambulance to the hospital and was admitted for "a couple of hours." He was discharged to rest at home. The following day, the pt continued to complain of nausea, dizziness, and weakness. On 1/29/04, the pt reported to the nurse that he was "doing fine." The events, which were described as having jeopardized the pt/ required intervention, were associated with a potential product complaint.  Follow up information received on 03/22/04 states: "He was discharged to rest at home. The following day, the pt remained off work for ordered rest, and continued to complain of nausea, dizziness, and weakness. On 01/27/04 the fatigue and injection site pain resolved. The events, which were described as life-threatening and as having jeopardized the pt/required intervention, were associated with a potential product complaint. The immunization series with Engerix-B was discontinued. The nurse considered the events to possibly be related to vaccination with Engerix-B.  Case Number A0495290A is a duplicate of A0496327A.  All future correspondence will be submitted to A0496327A."
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Dyspnoea, Extrasystoles, Hyperglycaemia, Hyperhidrosis
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site reaction in a male pt in his fifties who received hep B vaccine recombinant (Engerix B). Medical history included diabetes, and the pt was described as "rather large." On 1/27/04 the pt received Engerix B (5465A6). At the time of vaccination, the pt experienced an injection site reaction characterized by injection site pain. While walking from the examination room, the pt complained of weakness and subsequently collapsed. The pt was moved by wheelchair to an examination room, where his blood sugar level was 199. A blood pressure was not taken because a blood pressure cuff could not be placed on the pt's arm. The pt developed a "pulse of 52 and skipping," pallor, sweating, SOB, coolness to touch, and nausea. He was transported by ambulance to the hospital and was admitted for "a couple of hours." He was discharged to rest at home. The following day, the pt continued to complain of nausea, dizziness, and weakness. On 1/29/04, the pt reported to the nurse that he was "doing fine." The events, which were described as having jeopardized the pt/ required intervention, were associated with a potential product complaint.  Follow up information received on 03/22/04 states: "He was discharged to rest at home. The following day, the pt remained off work for ordered rest, and continued to complain of nausea, dizziness, and weakness. On 01/27/04 the fatigue and injection site pain resolved. The events, which were described as life-threatening and as having jeopardized the pt/required intervention, were associated with a potential product complaint. The immunization series with Engerix-B was discontinued. The nurse considered the events to possibly be related to vaccination with Engerix-B.  Case Number A0495290A is a duplicate of A0496327A.  All future correspondence will be submitted to A0496327A."
Sex: M
Vaccine: HEP
Symptoms: Injection site pain, Injection site reaction, Nausea, Pallor
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site reaction in a male pt in his fifties who received hep B vaccine recombinant (Engerix B). Medical history included diabetes, and the pt was described as "rather large." On 1/27/04 the pt received Engerix B (5465A6). At the time of vaccination, the pt experienced an injection site reaction characterized by injection site pain. While walking from the examination room, the pt complained of weakness and subsequently collapsed. The pt was moved by wheelchair to an examination room, where his blood sugar level was 199. A blood pressure was not taken because a blood pressure cuff could not be placed on the pt's arm. The pt developed a "pulse of 52 and skipping," pallor, sweating, SOB, coolness to touch, and nausea. He was transported by ambulance to the hospital and was admitted for "a couple of hours." He was discharged to rest at home. The following day, the pt continued to complain of nausea, dizziness, and weakness. On 1/29/04, the pt reported to the nurse that he was "doing fine." The events, which were described as having jeopardized the pt/ required intervention, were associated with a potential product complaint.  Follow up information received on 03/22/04 states: "He was discharged to rest at home. The following day, the pt remained off work for ordered rest, and continued to complain of nausea, dizziness, and weakness. On 01/27/04 the fatigue and injection site pain resolved. The events, which were described as life-threatening and as having jeopardized the pt/required intervention, were associated with a potential product complaint. The immunization series with Engerix-B was discontinued. The nurse considered the events to possibly be related to vaccination with Engerix-B.  Case Number A0495290A is a duplicate of A0496327A.  All future correspondence will be submitted to A0496327A."
Age: 3.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Convulsion, Epilepsy, Febrile convulsion, Grand mal convulsion, Salivary hypersecretion
Clinical narrative: A three year old female pt with no previous medical conditions, developed seizures following treatment with RabAvert. The reporter states that the pt has no history of head trauma and no family history of seizures. The pt was bitten by a grondhog in Oct 01 and given the first dose on 10/22/01. She was given subsequent doses on days 3, 7, 14, and 28. The pt developed seizures in Jan 02 described as foaming at the mouth with tremors. She later had a grand mal seizure in May 02 lasting 20 minutes. The pt was taken to the emergency room after that and diagnosed with febrile seizures. After the first grand mal, she had 4 or 5 seizures. In May 03, the reporter approached the physician to re-examine the pt. On 7/1/03, she was diagnosed with epilepsy. The pt has been treated with Lamictal, Trileptal and Depakote on different regimens. She is currently on Depakote and Trileptal. The reporter also stated that the pt had mental and motor skills of a 3 1/2 year old child, but was thought to be advanced for her age prior to groundhog bite and RabAvert injections. Follow up received 8/12/04: The patient received RabAvert on the following dates, 10/22/01, 10/25/01, 10/29/01, 11/5/01, and 11/19/01. The patient was diagnosed with intractable epilepsy.