chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Injection site erythema, Irritability, Lethargy, Malaise, Pruritus
Clinical narrative: Initial report received on 22Aug06 from another manf who originally received the report from a pharmacist who received the report from a physician. A 5 yr old male pt with no known allergies and a history of gastroesophageal reflux, and periodic breathing difficulty had received a fourth IM dose of Ipol, lot number Y0298, in the left thigh; a fifth IM dose of Infanrix, lot number AC14B008AA, in the left thigh; and a second SC dose of MMR II vaccine, in the right thigh, on 31May06 at 15:15PM. Approx ten minutes post immunization, the pt became uncomfortable, did not feel well, and began to have severe vomiting. This was followed by extreme itchiness of his feet, and whole body redness with hives on his left shoulder. The pt was fussy, disoriented, lethargic, and having trouble staying awake. He wanted to sleep. His blood pressure was 40mm systolic compared to 80mm systolic prior to the vaccinations. He was given oxygen, and an Epipen was administered. The pt was transported to the ER. On examination in the ER, the pt was somewhat unresponsive and needed a lot of stimulation to get him to wake up. He was erythematous all over but the hives had resolved. His vital signs were stable and he was treated with IV fluids, a second dose of epinephrine, Zantac, Zyrtec, and Solumedrol. By 17:00pm, the pt's erythema had resolved. His diagnosis was anaphylactic reaction likely secondary to the MMR II vaccine. The pt's recovery status was reported as being recovered on 01Jun06, the date of discharge from the hospital. The pt was discharged with a steroid for five days, a proton pump inhibitor, antihistamine for one month and an Epipen. Per the reporter, the pt had received a first dose of MMR vaccine, lot number 642645/0527M, on 29Aug02 with no problems. Per the other manf, the records of testing prior to release of Lot 649811/0491R in question have been rechecked and found to be satisfactory. The lot 649811/0491R met the requirements and was released by the regulatory agency. The event of anaphylactic reaction was considered by the other manf to be immediately life threatening, disabling and other important medical event (OMIC).
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Somnolence, Urticaria, Vomiting
Clinical narrative: Initial report received on 22Aug06 from another manf who originally received the report from a pharmacist who received the report from a physician. A 5 yr old male pt with no known allergies and a history of gastroesophageal reflux, and periodic breathing difficulty had received a fourth IM dose of Ipol, lot number Y0298, in the left thigh; a fifth IM dose of Infanrix, lot number AC14B008AA, in the left thigh; and a second SC dose of MMR II vaccine, in the right thigh, on 31May06 at 15:15PM. Approx ten minutes post immunization, the pt became uncomfortable, did not feel well, and began to have severe vomiting. This was followed by extreme itchiness of his feet, and whole body redness with hives on his left shoulder. The pt was fussy, disoriented, lethargic, and having trouble staying awake. He wanted to sleep. His blood pressure was 40mm systolic compared to 80mm systolic prior to the vaccinations. He was given oxygen, and an Epipen was administered. The pt was transported to the ER. On examination in the ER, the pt was somewhat unresponsive and needed a lot of stimulation to get him to wake up. He was erythematous all over but the hives had resolved. His vital signs were stable and he was treated with IV fluids, a second dose of epinephrine, Zantac, Zyrtec, and Solumedrol. By 17:00pm, the pt's erythema had resolved. His diagnosis was anaphylactic reaction likely secondary to the MMR II vaccine. The pt's recovery status was reported as being recovered on 01Jun06, the date of discharge from the hospital. The pt was discharged with a steroid for five days, a proton pump inhibitor, antihistamine for one month and an Epipen. Per the reporter, the pt had received a first dose of MMR vaccine, lot number 642645/0527M, on 29Aug02 with no problems. Per the other manf, the records of testing prior to release of Lot 649811/0491R in question have been rechecked and found to be satisfactory. The lot 649811/0491R met the requirements and was released by the regulatory agency. The event of anaphylactic reaction was considered by the other manf to be immediately life threatening, disabling and other important medical event (OMIC).
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Anaphylactic shock
Clinical narrative: Initial report received on 8/22/06 from another manufacturer who received the initial report from a nurse, with a reference number WAES0608USA00474. A five year old male pt with a history of cardiac disorder and previous heart surgeries (dates and number of surgeries not specified) had received a dose of IPOL, a dose of Infanrix, and a first dose of MMR II, lot number 653751/0499F, on 8/1/06. The lot numbers, routes and sites of administration were unknown for the IPOL and the Infanrix Vaccines. Within five minutes post immunization, the pt turned beet red, developed rashy red bumps and vomited. The pt said that his tongue hurt and stopped talking. The pt went into anaphylactic shock and was immediately treated with epinephrine and a IV line was placed. The pt was sent to the hospital as a direct admit. The treatment and diagnostic testing lab date performed in the hospital were not reported. The pt was discharged from the hospital on an unspecified date. The recovery status of the pt was reported as recovered on 8/2/06. The pts anaphylactic shock was considered to be life threatening.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Anaphylactic shock, Aphasia, Erythema, Glossodynia, Rash
Clinical narrative: Initial report received on 8/22/06 from another manufacturer who received the initial report from a nurse, with a reference number WAES0608USA00474. A five year old male pt with a history of cardiac disorder and previous heart surgeries (dates and number of surgeries not specified) had received a dose of IPOL, a dose of Infanrix, and a first dose of MMR II, lot number 653751/0499F, on 8/1/06. The lot numbers, routes and sites of administration were unknown for the IPOL and the Infanrix Vaccines. Within five minutes post immunization, the pt turned beet red, developed rashy red bumps and vomited. The pt said that his tongue hurt and stopped talking. The pt went into anaphylactic shock and was immediately treated with epinephrine and a IV line was placed. The pt was sent to the hospital as a direct admit. The treatment and diagnostic testing lab date performed in the hospital were not reported. The pt was discharged from the hospital on an unspecified date. The recovery status of the pt was reported as recovered on 8/2/06. The pts anaphylactic shock was considered to be life threatening.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Skin discolouration, Vomiting
Clinical narrative: Initial report received on 8/22/06 from another manufacturer who received the initial report from a nurse, with a reference number WAES0608USA00474. A five year old male pt with a history of cardiac disorder and previous heart surgeries (dates and number of surgeries not specified) had received a dose of IPOL, a dose of Infanrix, and a first dose of MMR II, lot number 653751/0499F, on 8/1/06. The lot numbers, routes and sites of administration were unknown for the IPOL and the Infanrix Vaccines. Within five minutes post immunization, the pt turned beet red, developed rashy red bumps and vomited. The pt said that his tongue hurt and stopped talking. The pt went into anaphylactic shock and was immediately treated with epinephrine and a IV line was placed. The pt was sent to the hospital as a direct admit. The treatment and diagnostic testing lab date performed in the hospital were not reported. The pt was discharged from the hospital on an unspecified date. The recovery status of the pt was reported as recovered on 8/2/06. The pts anaphylactic shock was considered to be life threatening.
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial information received on 8/25/06 from a health care professional. A 17 year old female pt received a first dose of Menactra, lot number U2119AA, administered IM in the right arm on 8/17/06 at 11:30am. Approximately 60 to 30 seconds. The pt felt weak and dizzy. Emergency medical services were called. The pts blood sugar was 113, blood pressure 86/68, pulse 78. She was transported to the ER. A basic metabolic profile and CBC were completed, however, no results were provided. The pt was observed for two to three hours and was discharged. She recovered from the events.
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Asthenia, Blood glucose increased, Dizziness
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial information received on 8/25/06 from a health care professional. A 17 year old female pt received a first dose of Menactra, lot number U2119AA, administered IM in the right arm on 8/17/06 at 11:30am. Approximately 60 to 30 seconds. The pt felt weak and dizzy. Emergency medical services were called. The pts blood sugar was 113, blood pressure 86/68, pulse 78. She was transported to the ER. A basic metabolic profile and CBC were completed, however, no results were provided. The pt was observed for two to three hours and was discharged. She recovered from the events.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypokinesia, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a certified medical assistant concerning a female (age unknown), with unknown medical history, who in Nov 2005, was vaccinated IM with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot unknown). Subsequently, in Nov 2005, the pt developed large swollen arm, with redness and tenderness at the injection site. The injection site reaction spread to the whole arm and she could not move the arm. The reporter and the doctor felt that the pts experience was serious because of the symptoms. Subsequently, the pt recovered in a few days. Unspecified medical attention was sought. No product quality complaint was involved. The pts experience, large swollen arm, with redness at the injection site, tenderness at the injection site, injection site reaction spread to the whole arm and could not move the arm were considered to be other important medical events by the reporter (OMIC). Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Tenderness
Clinical narrative: Information has been received from a certified medical assistant concerning a female (age unknown), with unknown medical history, who in Nov 2005, was vaccinated IM with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot unknown). Subsequently, in Nov 2005, the pt developed large swollen arm, with redness and tenderness at the injection site. The injection site reaction spread to the whole arm and she could not move the arm. The reporter and the doctor felt that the pts experience was serious because of the symptoms. Subsequently, the pt recovered in a few days. Unspecified medical attention was sought. No product quality complaint was involved. The pts experience, large swollen arm, with redness at the injection site, tenderness at the injection site, injection site reaction spread to the whole arm and could not move the arm were considered to be other important medical events by the reporter (OMIC). Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Hot flush, Hypokinesia, Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from a certified medical assistant concerning a 36 year old female, with no medical history reported, who on 12/30/2005 was vaccinated IM with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot unknown). Concomitant therapy included montelukast sodium and budesonide (Pulmicort). On 12/30/05 th pt developed large swollen arm with redness and tenderness at the injection site. She also experienced chills and hot flashed. The pt called the doctor on call. The physician recommended the use of ice packs. The injection site reaction spread to the whole upper arm and she could not move the arm. The reporter and the doctor felt that the pts experience was serious because of the symptoms. Subsequently, by 1/4/06 ht pt got better but the arm was still tender. The clinical outcome was reported as recovered. No product quality complaint was involved. The pts experience, injection site reaction, swollen arm, redness and tenderness at the injection site, chills, hot flashes, could not move the arm, and arm still tender were considered to be other important medical events by the reporter (OMIC). Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Information has been received from a certified medical assistant concerning a 36 year old female, with no medical history reported, who on 12/30/2005 was vaccinated IM with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot unknown). Concomitant therapy included montelukast sodium and budesonide (Pulmicort). On 12/30/05 th pt developed large swollen arm with redness and tenderness at the injection site. She also experienced chills and hot flashed. The pt called the doctor on call. The physician recommended the use of ice packs. The injection site reaction spread to the whole upper arm and she could not move the arm. The reporter and the doctor felt that the pts experience was serious because of the symptoms. Subsequently, by 1/4/06 ht pt got better but the arm was still tender. The clinical outcome was reported as recovered. No product quality complaint was involved. The pts experience, injection site reaction, swollen arm, redness and tenderness at the injection site, chills, hot flashes, could not move the arm, and arm still tender were considered to be other important medical events by the reporter (OMIC). Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Convulsion, Pyrexia
Clinical narrative: Information has been received from a RN concerning her 1 yr old daughter who on an unspecified date, was vaccinated SC with a single 0.5ml dose of MMR (+) varicella virus vaccine live. Eight days after vaccination, the pt developed a high temp ranging from 99 to 103 degrees. The pt also had seizures. The pt's mother felt that the high temp was life threatening. Unspecified medical attention was sought. There was no product quality complaint involved. The child fully recovered. Upon internal review, seizures were considered to be an other important medical event (OMIC). The pt is one of triplets, her sisters (WAES0608USA05187 and 0608USA05188) also had adverse experiences after vaccination with MMR (+) varicella virus vaccine live. Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Headache, Malaise
Clinical narrative: Approx 15 days post receipt SPV pt developed substernal pressure accompanied by dyspnea, described as like someone sitting my chest and significantly increased with lying and sitting and reduced when standing up - See VHC clinical summary. Symptoms Dyspnea (shortness of breath), chest pain felt like someone sitting on my chest, fever nasal drainage (runny nose, also reports sore throat), headache, malaise (<60 days).
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Pharyngolaryngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: Approx 15 days post receipt SPV pt developed substernal pressure accompanied by dyspnea, described as like someone sitting my chest and significantly increased with lying and sitting and reduced when standing up - See VHC clinical summary. Symptoms Dyspnea (shortness of breath), chest pain felt like someone sitting on my chest, fever nasal drainage (runny nose, also reports sore throat), headache, malaise (<60 days).
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Alopecia, Anxiety, Arthralgia, Asthenia, Blindness
Clinical narrative: Weakness, joint pain, migraine, anxiety, depression, hair loss, insomnia, blackouts, muscle pain, skin disorder, hearing loss, loss vision, finger and toes go numb for min. DX: PTSD Chronic low back pain Migraine Major depression/single acute URI HX of affective disorder.
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Depression, Hypoacusis, Hypoaesthesia, Insomnia, Loss of consciousness
Clinical narrative: Weakness, joint pain, migraine, anxiety, depression, hair loss, insomnia, blackouts, muscle pain, skin disorder, hearing loss, loss vision, finger and toes go numb for min. DX: PTSD Chronic low back pain Migraine Major depression/single acute URI HX of affective disorder.
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Migraine, Myalgia, Skin disorder, Urinary tract infection
Clinical narrative: Weakness, joint pain, migraine, anxiety, depression, hair loss, insomnia, blackouts, muscle pain, skin disorder, hearing loss, loss vision, finger and toes go numb for min. DX: PTSD Chronic low back pain Migraine Major depression/single acute URI HX of affective disorder.
Age: 70.0
Sex: F
Vaccine: HEPA
Symptoms: Angioedema, Asthma, Coronary artery disease, Dyspnoea, Dyspnoea
Clinical narrative: 36 hours after shot, face bloated and unrecognizable.  Complaint that her throat was closing and may not be able to breathe much longer. Medical records include dyspnea.  10/6/06 Received medical records from hospital which indicate patient had significant medical history prior to admission including multiple drug allergies.  Experienced hives, angioedema & slight SOB.  10/12/06 Received D/C summary which revealed patient admitted on 8/31 & d/c home on 9/5/06 w/final dx: angioedema; asthma; allergic rhinitis; HTN; hyperlipidemia; GERD, Meniers disease; CAD; & osteoarthritis.  PCP had seen patient on day of admission for facial & lip swelling & hives./ss Follow-up: Pt seen in office 8-30-06 - treated with PO meds and condition worsened -admitted 8-31-06.
Age: 70.0
Sex: F
Vaccine: HEPA
Symptoms: Gastrooesophageal reflux disease, Hyperlipidaemia, Hypertension, Lip swelling, Meniere's disease
Clinical narrative: 36 hours after shot, face bloated and unrecognizable.  Complaint that her throat was closing and may not be able to breathe much longer. Medical records include dyspnea.  10/6/06 Received medical records from hospital which indicate patient had significant medical history prior to admission including multiple drug allergies.  Experienced hives, angioedema & slight SOB.  10/12/06 Received D/C summary which revealed patient admitted on 8/31 & d/c home on 9/5/06 w/final dx: angioedema; asthma; allergic rhinitis; HTN; hyperlipidemia; GERD, Meniers disease; CAD; & osteoarthritis.  PCP had seen patient on day of admission for facial & lip swelling & hives./ss Follow-up: Pt seen in office 8-30-06 - treated with PO meds and condition worsened -admitted 8-31-06.
Age: 70.0
Sex: F
Vaccine: HEPA
Symptoms: Osteoarthritis, Pharyngeal oedema, Rhinitis allergic, Swelling face, Urticaria
Clinical narrative: 36 hours after shot, face bloated and unrecognizable.  Complaint that her throat was closing and may not be able to breathe much longer. Medical records include dyspnea.  10/6/06 Received medical records from hospital which indicate patient had significant medical history prior to admission including multiple drug allergies.  Experienced hives, angioedema & slight SOB.  10/12/06 Received D/C summary which revealed patient admitted on 8/31 & d/c home on 9/5/06 w/final dx: angioedema; asthma; allergic rhinitis; HTN; hyperlipidemia; GERD, Meniers disease; CAD; & osteoarthritis.  PCP had seen patient on day of admission for facial & lip swelling & hives./ss Follow-up: Pt seen in office 8-30-06 - treated with PO meds and condition worsened -admitted 8-31-06.
Age: 37.0
Sex: M
Vaccine: SMALL
Symptoms: Chills, Erythema, Injection site abscess, Lymphangitis, Malaise
Clinical narrative: "Robust Take with Lymphangitis"  Persistent 103F Fever-3 Days, Chills, Extreme Malaise, Redness throughout upper Left Forearm, Welt approximately 2" in diameter at injection site.  Unable to report for work for 7 Days.  Welt was drained approximately 19 days after injection.  Block 13: Route--multiple puncture vaccination; 3 punctures.
Age: 37.0
Sex: M
Vaccine: SMALL
Symptoms: Pyrexia, Urticaria
Clinical narrative: "Robust Take with Lymphangitis"  Persistent 103F Fever-3 Days, Chills, Extreme Malaise, Redness throughout upper Left Forearm, Welt approximately 2" in diameter at injection site.  Unable to report for work for 7 Days.  Welt was drained approximately 19 days after injection.  Block 13: Route--multiple puncture vaccination; 3 punctures.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Crying, Eye movement disorder, Irritability, Loss of consciousness
Clinical narrative: Mom reports that at approx 4pm on 9/1/06 patient's eyes rolled up in his head, he fell off of his chair and was unconscious for a short time.  She observed him for awhile, but he was "not himself" Pt taken to ER was observed and sent home.  He continued to be irritable and cried easily, would not get dressed. Mom called this am saying pt was still not acting quite right.  We have scheduled pt for eval by neurology on 9/8/06
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Erythema, Eye movement disorder, Lethargy, Swelling, Vomiting
Clinical narrative: Mother said child's left leg had excessive swelling and redness. He was lethargic and his eyes started to roll back. Vomited once. She took him to the ER.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Alopecia, Alopecia areata
Clinical narrative: After having the first 2 Hep B shots, her hair began to fall out.  We had no idea that the vaccine could be causing this, and so we followed with the last shot on 2/10/98.  From around Oct. 1997 through May 1998, her hair continued to fall out.  A dermatologist diagnosed her with alopecia areata.  Months of treatment followed, including cortisone shots in her head in the bald places.  We also used special shampoos & treatments for the alopecia.  In addition, I must add that the emotional trauma that this caused was intense.  Around June of 1998, her hair stared growing back.  She recovered and has not had another incidence of alopecia since then.
Age: 56.0
Sex: M
Vaccine: RAB
Symptoms: Influenza like illness, Interstitial lung disease
Clinical narrative: Initial report received on 22/Aug/2006 from a health care professional.  A 57-year-old male patient, with no past medical history, had received his third dose injection of Imovax, lot number unknown, on 15/Aug/2006.  He had received his first dose of Imovax on 08/Aug/2006, and his second dose injection on 11/Aug/2006.  On the same day following his third dose injection, the patient experienced "flu-like symptoms".  He was examined by a physician and subsequently hospitalized with a diagnosis of interstitial pneumonia.  Per the reporter, the patient " is not responding to antibiotics and is now in the intensive care unit".  At the time of this report, the patient had not recovered.
Age: 22.0
Sex: F
Vaccine: DTAP
Symptoms: Diarrhoea, Dyspnoea, Medication error, Pain, Pyrexia
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 8/22/06 from a health care professional. A 21 year old female pt had received a left deltoid injection of Tripedia, (product not recommended for administration in this age group), lot number U1751CA, on 8/18/06. Within 24 hours post vaccination, the pt developed fever, aches and diarrhea. Four days post vaccination, the pt was experiencing shortness of breath. The event required examination by a physician. the pt had recovered by 8/22/06.
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 8/23/06 from a health care professional. A 58 year old male pt, with a past medical history of hypertension, had received an IM, left arm injection of Adacel, lot number C2556AA, on 8/11/2006. He had no illness at the time of vaccination. Eight days post vaccination, the pt developed generalized hives. He was examined by a physician four days afterwards and was treated with a Kenalog injection, oral Atarax and prednisone. At the time of this report, the pt had not recovered.
Age: 12.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Cough, Dizziness, Fall, Headache, Throat tightness
Clinical narrative: Within 5 min of receiving the injection pt experienced dizziness, fell to the floor, then c/o lump in throat, then occasional hives. Tx With epi pen, PO Benadryl, PO Prednisone. BP always stable.  10/12/06 Received medical records from provider which reveal patient initially had dizziness & had to lie down.  Then started to develop numbness of lips, fullness in back of throat & hives.  EpiPen given which resolved most of s/s but continued to be dizzy.  Taken by ambulance to ER where she received IVF & Benadryl.  She developed headache & treated with ibuprofen.  Admitted for overnight observation.  Seen by PCP next day & patient had HA & cough which was getting worse (pt had hx of cough & asthma w/URIs).
Age: 12.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Urticaria
Clinical narrative: Within 5 min of receiving the injection pt experienced dizziness, fell to the floor, then c/o lump in throat, then occasional hives. Tx With epi pen, PO Benadryl, PO Prednisone. BP always stable.  10/12/06 Received medical records from provider which reveal patient initially had dizziness & had to lie down.  Then started to develop numbness of lips, fullness in back of throat & hives.  EpiPen given which resolved most of s/s but continued to be dizzy.  Taken by ambulance to ER where she received IVF & Benadryl.  She developed headache & treated with ibuprofen.  Admitted for overnight observation.  Seen by PCP next day & patient had HA & cough which was getting worse (pt had hx of cough & asthma w/URIs).
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Dermatitis bullous, Injection site erythema, Injection site swelling
Clinical narrative: Swelling, erythema, bulla, R thigh, knee; with secondary reticular pattern down leg and foot.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Unevaluable event
Clinical narrative: None Stated
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, IPV, MMRV
Symptoms: Injection site rash
Clinical narrative: Rash on bilateral deltoid area 5 days after receiving DTP, IPV, MMR. Rest ok ROS Neg
Age: 9.0
Sex: M
Vaccine: TDAP
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Mom called 8/28/06. Pt had Tdap on 08/27/06. Pt c/o N/V and diarrhea.
Age: 44.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Arthralgia, Arthritis, Back pain, Chills, Diabetes mellitus
Clinical narrative: Diabetes, pain in joints while standing and sitting, numbness in hands, cramps, chills, fever, back pain, erectile dysfunction, arthritis.
Age: 44.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Erectile dysfunction, Hypoaesthesia, Muscle spasms, Pyrexia
Clinical narrative: Diabetes, pain in joints while standing and sitting, numbness in hands, cramps, chills, fever, back pain, erectile dysfunction, arthritis.
Age: 48.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Dyspnoea, Erectile dysfunction, Pain, Sleep disorder
Clinical narrative: Shoulders and elbows pain for 3 yrs, short breath, sleeping problems, erectile dysfunction. Thigh pain.
Age: 13.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash, Rash pruritic
Clinical narrative: Vaccines given on 8/02/06 mom calls on 8/14/06 kid away at camp, developed rash, itchy bumps, went to an ER (I have no info from ER).
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Irritability, Pyrexia
Clinical narrative: Had a high fever of 104 and irritability after shots on 6/27/06. Mother did not tell MD until 8/28/06.
Age: 1.0
Sex: M
Vaccine: MMR, PNC
Symptoms: Injection site erythema
Clinical narrative: 8 1/2 x 3 1/2 cm pink area to left upper outer aspect of thigh. No treatment.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: 5 inch diameter erythematous, warm, circular area/mil swelling at site of Varivax injection L arm.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Ear discomfort, Feeling hot, Injection site pain, Injection site swelling, Lymph node pain
Clinical narrative: Site pain, swelling and heat. Pain radiated into neck and ear. Had ear canal swollen with drainage. Subclavicular node swollen and painful. Hives on arm.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Lymphadenopathy, Urticaria
Clinical narrative: Site pain, swelling and heat. Pain radiated into neck and ear. Had ear canal swollen with drainage. Subclavicular node swollen and painful. Hives on arm.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Feeling hot, Rash erythematous, Rash macular
Clinical narrative: Child presented in clinic after visit to ER for c/o hot rash to R thigh. Reported syringe blew off during administration. Child's leg was red blotchy in appearance, redness was not bold but covered 60-70% of R thigh anterior and medial.
Age: 11.0
Sex: F
Vaccine: HEPA, MMR
Symptoms: Injection site reaction
Clinical narrative: Pt came in for well exam 8/30/06, received Hep A #2 R arm, Varivax #2 L arm, came in 8/31/06 with reaction at site of L arm 4 in in diameter.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Hypoacusis, Lung disorder, Night sweats, Pneumonia
Clinical narrative: On 7/6/06 client came to HD stating that on 11/08/05 he had a flu shot that resulted in many untoward side effects necessitating Dr visits and testing. S/s began 2 days after shot with night sweats and one-two wks later needed CXR and antibiotics for Dx of pneumonia or a spot on lung which he is still being followed up for and is scheduled for a CT of lungs. Also saw Dr for hearing loss and sinus problems. Had about 10 Dr visits since onset to date. Coughing resolved but lung spot remains for weeks. Still testing and follow up in process.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Sinusitis
Clinical narrative: On 7/6/06 client came to HD stating that on 11/08/05 he had a flu shot that resulted in many untoward side effects necessitating Dr visits and testing. S/s began 2 days after shot with night sweats and one-two wks later needed CXR and antibiotics for Dx of pneumonia or a spot on lung which he is still being followed up for and is scheduled for a CT of lungs. Also saw Dr for hearing loss and sinus problems. Had about 10 Dr visits since onset to date. Coughing resolved but lung spot remains for weeks. Still testing and follow up in process.
Age: 1.01
Sex: F
Vaccine: HIBV, IPV, MMR, PNC, VARCEL
Symptoms: Convulsion, Pyrexia
Clinical narrative: Father called on 6/12/06 5:15pm to HD, stated wife told him pt was taken to UC (urgent care) on  6/11/06 2AM with fever started 11PM 105deg and seizure, not sure what UC did for her and not sure f/u instructions since he and his wife are in custody battle. He will take pt to see Dr in couple days. Pt has no fever or seizure activation noted since he has pt today, just finishing dinner. Dad has pt 4 nights a week, last saw her on 6/8/06.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Chest discomfort, Confusional state, Dysphonia, Dyspnoea, Urticaria
Clinical narrative: 15-20 min after receiving vaccine client reported experiencing tightness in chest, hoarse voice, difficulty breathing, hives and confusion. Was taken to urgent care by her neighbor, was treated with steroids and Benadryl. Client advised by Doctor to no receive anymore vaccines for HBV.
Age: 4.0
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Dtap L upper leg localized erythema on leg, mild pruritis local only.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Haematochezia
Clinical narrative: Infant received 1st dose of Rotateq on 8/28/06. Mom noticed blood in 2 stools on 8/30/06. No vomiting, no other sx, infant exam nl.
Age: 39.0
Sex: M
Vaccine: RAB
Symptoms: Rash
Clinical narrative: 8-21-06 rash appeared on neck.  Following day, rash appeared over entire body 8-22-06 emergency room visit, 8-26-06 emergency room visit medication prescribed hydroxyzine and Medrol.
Age: 81.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Developed large area of redness induration extending 10 centimeter around site of Tetanus.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, PNC
Symptoms: Injection site swelling
Clinical narrative: Area of swelling (1 centimeter) on right anterior thigh at immunization site.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Injection site warmth
Clinical narrative: 6 centimeter by 4 centimeter red, warm to touch.
Age: 1.01
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Herpes zoster, Infection
Clinical narrative: Zoster/shingles right shoulder and chest C3, C4 distribution.  See photo
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Swelling
Clinical narrative: 6 by 7 centimeter redness and swelling with mild to moderate pain at right upper arm at 36-48 hours post injection of MMR #2, Hepatitis A #2.  No fever, no streaks.  Expect to do fine.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site warmth, Oedema, Pyrexia
Clinical narrative: Left thigh with 14.5 by 15.5 centimeter erythematous, edematous area, non tender, positive warm to touch, fever.
Sex: F
Vaccine: MMRV
Symptoms: Erythema
Clinical narrative: Red raised areas to chest/abdomen
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Injection site erythema, Nausea, Pain, Pyrexia
Clinical narrative: 1. fever, 2. body aches, 3. chills, 4. nausea, 5. redness at injection site
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Malaise, Pain
Clinical narrative: Generalized malaise, chills, body aches, weakness
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Injection site warmth, Pyrexia, Swelling
Clinical narrative: Right leg swollen, red and hot to touch, mom called with symptom at 3:50 on 8-24-06.  Was seen at 4:30 by provider and had 24 by 13 centimeter area of erythema with warmth.  Placed on KEFLEX 250/5 2 teaspoons twice a day for 7 days.  99.6 temperature at office at 4:30.
Age: 37.0
Sex: F
Vaccine: RAB
Symptoms: Anxiety, Headache, Injection site pain, Myalgia, Pharyngolaryngeal pain
Clinical narrative: Received series of rabies vaccine for bite of ferral cat which occurred abroad.  Received vaccination 5/24/06, 5/27/06,5/31, 6/7, 6/21 around 7/25/06 developed pain, left deltoid at site of injection.  Muscle pain in same arm and burning sensation in upper arm.  Approximately 8/1/06 developed low grade fever, sore throat, headache, anxiety.  Seen by medical profession in late July and again 8/14 or 15
Age: 37.0
Sex: F
Vaccine: RAB
Symptoms: Pyrexia
Clinical narrative: Received series of rabies vaccine for bite of ferral cat which occurred abroad.  Received vaccination 5/24/06, 5/27/06,5/31, 6/7, 6/21 around 7/25/06 developed pain, left deltoid at site of injection.  Muscle pain in same arm and burning sensation in upper arm.  Approximately 8/1/06 developed low grade fever, sore throat, headache, anxiety.  Seen by medical profession in late July and again 8/14 or 15
Sex: M
Vaccine: HEP, IPV, MMR, TD
Symptoms: Erythema, Injection site nodule, Injection site swelling, Urticaria
Clinical narrative: Patient received immunizations 8-15-06, Hepatitis B, Tetanus, IPV, MMR.  Grandmother reports child broke out in hives same day of immunization administration and resolved 3 days afterwards.  No welts seen on 8/23/06.  Red raised knot right deltoid at Tetanus site.
Age: 40.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness
Clinical narrative: 08-28-06 Hepatitis B vaccine 9third shot) given at 10:00 am.  10:15 employee states "dizzy".  Doctor instructed to sit and put head down.  10:30 ambulatory but state he still dizzy, made sit down again, blood pressure 128/84, pulse 87, temperature 98.1. Instructed to lie down but refused and left at 10:45 pm.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Pyrexia, Shoulder pain
Clinical narrative: I received Pertussis vaccine on Thursday 8-17-06, on Tuesday 8-22-06, I suddenly developed pain in shoulders, elbows, hips and knees bilaterally.  The pain was severe and I had a low grade temperature of 99.9 F.  The pain continued through Thursday 8-24-06 and I missed work on 8-23-06.  I could hardly walk due to the pain.
Age: 1.53
Sex: F
Vaccine: DTAP, HEP, IPV, DTAP, HEP, IPV, DTAP, HEP, IPV
Symptoms: Injection site hypersensitivity, Injection site reaction, Listless, Rash, Vomiting
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 8/8/06 from a nurse. An 18 month old female pt with no current illnesses, and a history of allergy to Rocephin had received a third SC dose of IPOL, lot number Y1051-2, in the left arm, a fourth IM dose of Tripedia lot number U1397AB, in the right anterior thigh, and a third IM dose of Hepatitis B vaccine, lot number AHBVB289CA, in the left anterior thigh, on 7/22/06 at 9:00am. Before the pt left the physicians office, the mother noted injection site redness at the Hepatitis B vaccine site. the injection site was still red, and at seven o'clock that night, the pt developed a rash all over her body, had started vomiting, and had become listless. The parents called 911, and the ambulance transported the pt to the ER. A CT scan was normal, and blood cultures, BMP, PHOS, UA and CBC were completed. The results of the lab work were not reported. Treatment received was not reported. The recovery status of the pt was reported as recovered. Follow up information received from another manufacturer, report number A0616357A, in 8/22/06. The initial report had been received from a health care professional. Ten hours following the vaccinations, at 7:00pm, the pt developed hives all over her body, and between 7:30 and 8:00pm, she developed vomiting and sleepiness. By 8:30pm, she was so lethargic that the paramedics were called. The ER physician determined that the pt had experienced a possible seizure based on the parents description of the event. On 7/23/2006, the events were resolved. Events in this case have been amended, and the case has been upgraded to serious based on this new medical information.
Age: 1.53
Sex: F
Vaccine: DTAP, HEP, IPV, DTAP, HEP, IPV, DTAP, HEP, IPV
Symptoms: Convulsion, Injection site erythema, Injection site reaction, Lethargy, Listless
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 8/8/06 from a nurse. An 18 month old female pt with no current illnesses, and a history of allergy to Rocephin had received a third SC dose of IPOL, lot number Y1051-2, in the left arm, a fourth IM dose of Tripedia lot number U1397AB, in the right anterior thigh, and a third IM dose of Hepatitis B vaccine, lot number AHBVB289CA, in the left anterior thigh, on 7/22/06 at 9:00am. Before the pt left the physicians office, the mother noted injection site redness at the Hepatitis B vaccine site. the injection site was still red, and at seven o'clock that night, the pt developed a rash all over her body, had started vomiting, and had become listless. The parents called 911, and the ambulance transported the pt to the ER. A CT scan was normal, and blood cultures, BMP, PHOS, UA and CBC were completed. The results of the lab work were not reported. Treatment received was not reported. The recovery status of the pt was reported as recovered. Follow up information received from another manufacturer, report number A0616357A, in 8/22/06. The initial report had been received from a health care professional. Ten hours following the vaccinations, at 7:00pm, the pt developed hives all over her body, and between 7:30 and 8:00pm, she developed vomiting and sleepiness. By 8:30pm, she was so lethargic that the paramedics were called. The ER physician determined that the pt had experienced a possible seizure based on the parents description of the event. On 7/23/2006, the events were resolved. Events in this case have been amended, and the case has been upgraded to serious based on this new medical information.
Age: 1.53
Sex: F
Vaccine: DTAP, HEP, IPV, DTAP, HEP, IPV, DTAP, HEP, IPV
Symptoms: Rash, Somnolence, Urticaria, Vomiting
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 8/8/06 from a nurse. An 18 month old female pt with no current illnesses, and a history of allergy to Rocephin had received a third SC dose of IPOL, lot number Y1051-2, in the left arm, a fourth IM dose of Tripedia lot number U1397AB, in the right anterior thigh, and a third IM dose of Hepatitis B vaccine, lot number AHBVB289CA, in the left anterior thigh, on 7/22/06 at 9:00am. Before the pt left the physicians office, the mother noted injection site redness at the Hepatitis B vaccine site. the injection site was still red, and at seven o'clock that night, the pt developed a rash all over her body, had started vomiting, and had become listless. The parents called 911, and the ambulance transported the pt to the ER. A CT scan was normal, and blood cultures, BMP, PHOS, UA and CBC were completed. The results of the lab work were not reported. Treatment received was not reported. The recovery status of the pt was reported as recovered. Follow up information received from another manufacturer, report number A0616357A, in 8/22/06. The initial report had been received from a health care professional. Ten hours following the vaccinations, at 7:00pm, the pt developed hives all over her body, and between 7:30 and 8:00pm, she developed vomiting and sleepiness. By 8:30pm, she was so lethargic that the paramedics were called. The ER physician determined that the pt had experienced a possible seizure based on the parents description of the event. On 7/23/2006, the events were resolved. Events in this case have been amended, and the case has been upgraded to serious based on this new medical information.
Age: 1.53
Sex: F
Vaccine: DTAP, HEP, IPV, DTAP, HEP, IPV, DTAP, HEP, IPV
Symptoms: Convulsion, Injection site hypersensitivity, Lethargy, Somnolence, Urticaria
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 8/8/06 from a nurse. An 18 month old female pt with no current illnesses, and a history of allergy to Rocephin had received a third SC dose of IPOL, lot number Y1051-2, in the left arm, a fourth IM dose of Tripedia lot number U1397AB, in the right anterior thigh, and a third IM dose of Hepatitis B vaccine, lot number AHBVB289CA, in the left anterior thigh, on 7/22/06 at 9:00am. Before the pt left the physicians office, the mother noted injection site redness at the Hepatitis B vaccine site. the injection site was still red, and at seven o'clock that night, the pt developed a rash all over her body, had started vomiting, and had become listless. The parents called 911, and the ambulance transported the pt to the ER. A CT scan was normal, and blood cultures, BMP, PHOS, UA and CBC were completed. The results of the lab work were not reported. Treatment received was not reported. The recovery status of the pt was reported as recovered. Follow up information received from another manufacturer, report number A0616357A, in 8/22/06. The initial report had been received from a health care professional. Ten hours following the vaccinations, at 7:00pm, the pt developed hives all over her body, and between 7:30 and 8:00pm, she developed vomiting and sleepiness. By 8:30pm, she was so lethargic that the paramedics were called. The ER physician determined that the pt had experienced a possible seizure based on the parents description of the event. On 7/23/2006, the events were resolved. Events in this case have been amended, and the case has been upgraded to serious based on this new medical information.
Age: 1.53
Sex: F
Vaccine: DTAP, HEP, IPV, DTAP, HEP, IPV, DTAP, HEP, IPV
Symptoms: Vomiting
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 8/8/06 from a nurse. An 18 month old female pt with no current illnesses, and a history of allergy to Rocephin had received a third SC dose of IPOL, lot number Y1051-2, in the left arm, a fourth IM dose of Tripedia lot number U1397AB, in the right anterior thigh, and a third IM dose of Hepatitis B vaccine, lot number AHBVB289CA, in the left anterior thigh, on 7/22/06 at 9:00am. Before the pt left the physicians office, the mother noted injection site redness at the Hepatitis B vaccine site. the injection site was still red, and at seven o'clock that night, the pt developed a rash all over her body, had started vomiting, and had become listless. The parents called 911, and the ambulance transported the pt to the ER. A CT scan was normal, and blood cultures, BMP, PHOS, UA and CBC were completed. The results of the lab work were not reported. Treatment received was not reported. The recovery status of the pt was reported as recovered. Follow up information received from another manufacturer, report number A0616357A, in 8/22/06. The initial report had been received from a health care professional. Ten hours following the vaccinations, at 7:00pm, the pt developed hives all over her body, and between 7:30 and 8:00pm, she developed vomiting and sleepiness. By 8:30pm, she was so lethargic that the paramedics were called. The ER physician determined that the pt had experienced a possible seizure based on the parents description of the event. On 7/23/2006, the events were resolved. Events in this case have been amended, and the case has been upgraded to serious based on this new medical information.
Age: 0.25
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, RV5
Symptoms: Neutropenia, Petechiae, Platelet count decreased, Rash, Skin ulcer
Clinical narrative: Initial report received on 8/22/06 from another manufacturer, report number WAES0608USA01963. A three month old female pt, with no pre existing medical conditions, had received a right thigh, first dose injection of Daptacel, lot number C2407AA, a left thigh first dose injection of IPOL, lot number Y1068, a right thigh, first dose of injection of Comvax, lot number 653539/1193R, a first dose, oral administration of Rotateq, lot number 653915/0389F, and a left thigh, first dose injection of Prevnar, lot number B08651E, on 7/14/06. There were no other concomitant therapies and no illness at the time of vaccination. Fifteen days post vaccination, on 7/29/06, the pt was examined by a physician, and her platelet count was 7,000. The pt also had small petechial lesions spread all over her body. She was subsequently hospitalized and treated with IVIG 5 grams. Platelet count on 8/1/06 was 76,000 and on 8/8/06 was 693,000. At the time of this report, the pt had recovered.
Age: 0.25
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, RV5
Symptoms: Thrombocytopenic purpura
Clinical narrative: Initial report received on 8/22/06 from another manufacturer, report number WAES0608USA01963. A three month old female pt, with no pre existing medical conditions, had received a right thigh, first dose injection of Daptacel, lot number C2407AA, a left thigh first dose injection of IPOL, lot number Y1068, a right thigh, first dose of injection of Comvax, lot number 653539/1193R, a first dose, oral administration of Rotateq, lot number 653915/0389F, and a left thigh, first dose injection of Prevnar, lot number B08651E, on 7/14/06. There were no other concomitant therapies and no illness at the time of vaccination. Fifteen days post vaccination, on 7/29/06, the pt was examined by a physician, and her platelet count was 7,000. The pt also had small petechial lesions spread all over her body. She was subsequently hospitalized and treated with IVIG 5 grams. Platelet count on 8/1/06 was 76,000 and on 8/8/06 was 693,000. At the time of this report, the pt had recovered.