chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Sepsis
Clinical narrative: Information has been received from a physician concerning a 55 year old female pt with a history of hairy cell leukemia, and splenectomy who on 7/2/02 (also reported as "third quarter of 2002") was vaccinated with a second dose of pneumococcal vaccine 23 polyvalent (641115/1159L). Concomitant medications at the time of the vaccination were Celebrex, pyridoxine, homeopathic medications (Echinacea). On an unspecified date at the end of January 2003, the pt complained of fever, chills, and nausea. The physician reported the next morning the pt went to the ER and she was admitted to the hospital. Her condition continued to deteriorate progressing to positive blood cultures for pneumococcus, which was rpeorted as Pneumococcal sepsis. The physician also reported the pt experienced a stroke, and disseminated intravascular coagulation (DIC), and she was on the ventilator for a "few" days. Additionally the pt lost all of her fingers to amputation except for her thumbs on both hands. It was noted the pt remained in the acute care hospital for about one month and was then transferred to a rehabilitation hospital. According to the reporter, it was "fairly catastrophic," but now the pt is "much better," and she is undergoing physical therapy. The physician reported that he had seen the pt in his office about one month ago and she is making great progress, she drove herself to the appointment, and despite the stroke, she walks without any mechanical assistance. It was reported that the adverse event abated, and the pt is recovering with sequelae. The physician also mentioned a colleague had described a similar case (WAES0307USA03543), but details were not available. There was no product quality complaint involved. Pneumococcal sepsis, disseminated intravascular coagulation (DIC), stroke, and lost all fingers to amputation were considered to be immediately life-threatening. Pneumococcal sepsis, disseminated intravascular coagulation (DIC), stroke, and lost all fingers to amputation were considered to be disabling. Additional info has been requested. A 15-day follow up report received 10/27/2003 adds no new info.
Sex: U
Vaccine: PPV
Symptoms: Cerebrovascular accident, Disseminated intravascular coagulation, Sepsis
Clinical narrative: Information has been received from a physician, which was reported to him by a colleague, who is an infectious disease specialist, who reported that a pt had similar experience to the pt referred in WAES0307USA02888 (pneumococcal sepsis, disseminated intravascular coagulation (DIC), stroke, and loss of fingers), following vaccination with pneumococcal vaccine 23 polyvalent. The physician mentioned specific details were not available. Pneumococcal sepsis, disseminated intravascular sepsis, stroke, and loss of fingers were considered other important medical events (OMIC). Additional info has been requested.
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, High-pitched crying, Pyrexia, Screaming, Sleep terror
Clinical narrative: Information has been received from a consumer concerning her currently 8 year old son who in 1995 was vaccinated with a first dose of MMR (second generation) (lot # not reported). Soon after vaccination, the patient experienced having night terrors and he broke out in a fever. In addition, it was reported that the patient had been throwing his body into his crib and the walls. The patient woke one night with a high pitched scream and with uncontrollable fear. The patient also had screaming episodes and has had episodes of acting as a rabid dog like in the movies. The reporter stated that her son's behavior has definitely changed since receiving the vaccine. It was reported that even today, the patient easily flies off the handle and it was reported that these episodes could go on for a half an hour. No further information was provided. It was reported that the patient had not recovered. Upon internal review, night terrors, high pitched scream and screaming episodes, uncontrollable fear, behavior that has changed-throwing body into crib and walls, acting as a rabid dog and easily flies off the handle were determined to be other important medical events (OMIC). No further information is available.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Autism, Speech disorder
Clinical narrative: Information has been received from an occupational health registered nurse via the mother of a 3 year old male who in November 2000, when the patient was 11 months old, was vaccinated with MMR (second generation). In approximately June 2001, when the patient was approximately 18 months old, the mother reported she feels he now displays pre-autistic tendencies. The mother felt that pre-autistic tendencies was related to therapy with MMR (second generation). Unspecified medical attention was sought. Follow up information was received from the physician who reported that on 12/11/00, the patient was vaccinated with MMR (second generation) (lot # 636400/1276K). This was the only vaccination the child received on that date. The child was well at the time of the visit, and did not have any history of any allergies. In approximately 5/01, at 17-18 months of age, it was noted that the child was not as vocal has he should be at this age, and the child's behavior was noted to be uncooperative. At 2 years of age he was referred for hearing tests and the results were reported as normal. Also, at 2 years of age, the child was referred to the intermediate unit for speech therapy and intervention, it was reported that the child continued to be uncooperative during appointments. His speech had improved, with speech therapy he could now say short sentences. At the age of 2 years 7 months, another specialist saw the child and diagnosed the patient with Pervasive Developmental Delay. The physician reported that the child is currently 3 and one-half years old, speaks in small sentences, and continues to have uncooperative behavior. The physician reported that the patient has a sibling who is 18 months of age and has not been immunized with MMR (second generation). Upon internal review, pre-autistic tendencies and pervasive developmental delay were considered to be an other important medical event (OMIC). Additional information has been requested. A 15-day follow up report received 10/24/2003 adds: Follow up info was received from the physician who reported that the parent of the pt "wanted to cancel the report of their child's condition, as he is progressing to improve". Upon internal review, pre-autistic tendencies and pervasive developmental delay were considered to be an other important medical events. Additional info has been requested.
Age: 24.0
Sex: F
Vaccine: SMALL
Symptoms: Cellulitis, Feeling hot, Injection site oedema, Lymphadenopathy, Pain
Clinical narrative: 7/30 Pt developed large painful lymphadenopathy left avicular area, pain with moving neck. 7/31 approx 3" circumference erythematous warm rash surrounding vaccine site with swelling of anterior deltoid area. Rx with Tequin 400 mg po qd #5 cellulitis resolved after 5 days on Tequin.
Age: 24.0
Sex: F
Vaccine: SMALL
Symptoms: Rash erythematous
Clinical narrative: 7/30 Pt developed large painful lymphadenopathy left avicular area, pain with moving neck. 7/31 approx 3" circumference erythematous warm rash surrounding vaccine site with swelling of anterior deltoid area. Rx with Tequin 400 mg po qd #5 cellulitis resolved after 5 days on Tequin.
Age: 65.0
Sex: F
Vaccine: PPV, TD
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Pruritus
Clinical narrative: Injection site red, warm, 6cm x 8cm, not tender to touch, good ROM, itchy left shoulder.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Eye oedema, Pruritus
Clinical narrative: Developed itching, periorbital, swelling following vaccine about 15 minutes. Attempted po Benadryl without success. 2 hours pt cooperation. Gave 25 mg IM followed by relief of itching within 10 minutes.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Per phone call, erythematous and hot/warm to touch at injection site.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: 12/19-12/20/02 Fever. 12/21-12/14/02 Rash. Rash did not have fluid in it and did not break open and scab over.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Fatigue, Hepatomegaly, Joint swelling, Nausea
Clinical narrative: Enlarged painful liver. Low grade fever, joint swelling and pain, nausea, fatigue.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Pyrexia
Clinical narrative: Enlarged painful liver. Low grade fever, joint swelling and pain, nausea, fatigue.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Pyrexia
Clinical narrative: Local reaction with erythema, induration and increased local temperature.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Pruritus
Clinical narrative: On 7/25/03 pt was brought in to be checked, found 6 cm mild erythema left gluteus max. some redness and itching noted.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Rash
Clinical narrative: Called answering service on 7/31/03 at 18:15 complained of rash spreading up leg and rash around injection site. 8/1/03 called pt at 8:45, mother stated, "It has become bumpy and swollen with redness on the right leg. Advised pt's mother to bring him to be checked. 4 cm x 3 cm hot, red with induration.
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Feeling hot, Injection site oedema
Clinical narrative: Swelling of leg, slight warmth (left leg).
Age: 53.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis
Clinical narrative: Cellulitis of left arm vs allergic reaction. Clarinex 1 po qd x 7. Keflex 500 mg po x 10 TID.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Swelling and redness start 10 x 13cm over left thigh starting 10-12 hours after vaccine. Came to office. Treated for presumed infection with cladenysin.
Sex: F
Vaccine: HEP
Symptoms: Convulsion, Fatigue, Multiple sclerosis, Nausea, Vomiting
Clinical narrative: This case described the occurrence of "multiple sclerosis symptoms" in a female pt who received hep B vaccine recombinant (Engerix B) for prophylaxis. This report was received from the pt's spouse and has not been verified by a physician or other healthcare professional. On 6/24/03 the pt received an injection of Engerix B. "Early the next morning," on 6/25/03, the pt reportedly experienced a seizure and vomiting. The pt was taken to the local ER. The seizure and vomiting resolved. On 6/25/03, the pt also reportedly began to experience "multiple sclerosis symptoms" and "frequent" periods of nausea and fatigue. The pt was seen by a neurologist. As of 7/31/03, the "multiple sclerosis symptoms," fatigue, and nausea persisted. The pt's spouse considered all of the reported events to be probably related to Engerix B. He stated that the immunization schedule was discontinued; however, it was unclear if it was discontinued because of the events or because no further doses of vaccine were necessary. The reporter declined to provide additional information, and declined to grant authorization to manufacturer to contact the pt's neurologist. Therefore, no further info will be available. Seizure and "multiple sclerosis symptoms" are considered to be medically serious (OMIC).
Age: 0.6
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site oedema, Pain, Pyrexia
Clinical narrative: Right thigh with 3 cm edematous area, no erythema, no streaks given Rx for Keflex and ibuprofen susp. for fever/pain. Pt afebrile at home and in clinic.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Pruritus
Clinical narrative: 8/2/03 Pt complained of arm itching at 1:00 PM. Later that evening Mom noticed his right arm was red and hot to the touch. Went to ER that night. Arm measured 15 x 8". Recommended for Tylenol, Benadryl and cold compress.
Age: 13.0
Sex: M
Vaccine: HEPA, TD
Symptoms: Dizziness, Eye movement disorder
Clinical narrative: According to pt's dad, child complained of dizziness, 5 minutes after receiving TD and HAV. He laid him on the floor and he observed that ... stiffened...upper..motion and rolled his eyes back for 10-15 seconds x2 at a minute interval. BP 110/80 HP 82, Resp 24/m
Age: 40.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Headache, Malaise, Myalgia, Pain, Pyrexia
Clinical narrative: Fever up to 101 degrees. Headache, myalgias, malaise, injection site pain. No other symptoms.
Age: 0.75
Sex: F
Vaccine: PNC
Symptoms: Asthenia, Decreased appetite, Pyrexia, Somnolence
Clinical narrative: Drowsy after vaccination. Next day fever from 101.8-102.9 degrees, fever resided when took medication. Fever up and down for 5 days in total, always taking Motrin and Tylenol on a regular basis. During these days child was moaning like in pain, weak because did not want to eat but was not throwing up.
Age: 13.0
Sex: M
Vaccine: TTOX, VARCEL
Symptoms: Headache, Hypersensitivity, Syncope
Clinical narrative: After sitting for a bit after receiving the vaccination, the patient and I proceeded to the appointment desk to schedule the second shot.  While  talking with the clerk, he fainted and hit his head on the floor.  He was taken to an examination room where possible concussion was ruled out, he rested for approximately 45 minutes, and I took him home.  He slept at home for approximately two hours and had a headache all that evening for which he refused treatment.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Confusional state, Headache, Lethargy, Syncope
Clinical narrative: After receiving the vaccination, and the nurse being aware of his previous adverse reaction, he sat for approximately 5 minutes before being released.  I drove him home, approximately 1 mile away, and he fainted twice in the car.  I took him to a neighbor, and he fainted once on the sidewalk and again as we got him to the couch.  He slept for about an hour at the neighbor's house and asked to go home.  He called me from home but didn't remember how he got home or that he was home.  He sounded very confused on the phone.  I came home about 30 minutes later, and he had been sleeping again.  When I woke him, he was oriented to time and place, but he continued to be lethargic.  His energy level increased, we pushed fluids to increase blood volume, and he had a headache for the remainder of the evening.
Age: 55.0
Sex: F
Vaccine: SMALL
Symptoms: Cardiac failure congestive, Dyspnoea, Fatigue, Oedema, Palpitations
Clinical narrative: Palpitations 6 weeks after vaccination, resolved; then shortness of breath at rest and with exercise, fatigue, beginning approximately 100 days after vaccination.  Diagnosed with congestive heart failure.  Already on anti-arrythmics, antihyperlipidemics, begun on lisinopril, lasix, and appointment made with cardiologist on 08/11/03 for echocardiogram  Follow up 02/08/2005: Final diagnosis "palpitations without documented dysrhythmia; shortness of breath and prior history of premature ventricular contractions and shortness of breath. 01/04 Persistent symptoms of shortness of breath, palpitations and edema.
Age: 55.0
Sex: F
Vaccine: SMALL
Symptoms: Pulmonary hypertension
Clinical narrative: Palpitations 6 weeks after vaccination, resolved; then shortness of breath at rest and with exercise, fatigue, beginning approximately 100 days after vaccination.  Diagnosed with congestive heart failure.  Already on anti-arrythmics, antihyperlipidemics, begun on lisinopril, lasix, and appointment made with cardiologist on 08/11/03 for echocardiogram  Follow up 02/08/2005: Final diagnosis "palpitations without documented dysrhythmia; shortness of breath and prior history of premature ventricular contractions and shortness of breath. 01/04 Persistent symptoms of shortness of breath, palpitations and edema.
Age: 1.3
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever of 102 appeared four days after vaccine was administered.  Fever lasted for 4 days, lingering around 100 - 101 degrees.    Red rash appeared 9 days after the vaccine was given.  Rash appeared on nape of the neck, and quickly spread to the back and stomach.  Rash on the nape was extremely itchy.  Low grade fever of 99-100 reappeared 12 days after the vaccine for two more days.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Fever to 103.6 that same evenig; left shoulder swollen to about i/3 larger and erythema to the shoulder and upper arm.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Convulsion
Clinical narrative: PATIENT RECEIVED DTAP ON 7/28/03 REPORTED SEIZURE ON 8/2/03. SEIZURE WAS DESCRIBED TO ER PERSONEL AS GENERALIZED TONIC CLONIC SEIZURE. .0
Age: 1.0
Sex: M
Vaccine: HEP
Symptoms: Diarrhoea, Laboratory test abnormal, Lymphadenopathy
Clinical narrative: 1. Sever Lymphadenopathy immediately after vaccine and still enlarged lymph glands 2.5 post vaccine.  2. Diarrhea, loose stools, undigested food beginning after vaccination and lasting for 1.5 years.    3.Abnormal liver function tests immediately after vaccine.                        4/10/01   2/13/02  5/15/03   Alkaline Phosphatease 366 U/L   291 U/L  282 U/L Absolute Monocytes   1514 c/mcl normal   na Absolute Eosinophils  757 c/mcl normal   na White Blood Count     17.6      normal   na
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Apnoea, Cyanosis, Laboratory test abnormal, Pallor, Rash macular
Clinical narrative: This subject is a 2 month old male, who was admitted to the hospital due to near miss SIDS while enrolled in a Phase IV P3T08 study. The subject received one dose of study vaccine; the last dose prior to the event was given on 1/28/03. The subject became apneic and turned blue, shortly after immunization and was admitted to the hospital the same day. The subject required bag valve ventilation for several minutes to keep saturations within the normal range. 911 was called to the vaccination clinic. When the paramedics arrived, the subject was active and breathing on his own, but had three additional apneic spells requiring stimulation or short-term bagging until resolution. It is not known whether bradycardia accompanied his apneic spells. He did have some perioral cyanosis associated with him and cyanosis of mucous membranes. He did appear to be somewhat pale after resolution of all episodes. It was noted that the subject was developing a few red blotches on extremities and chest. Epinephrine was given prior to transport. He was transferred to the emergency room where he was evaluated and later admitted to the hospital ICU for observation. Upon arrival at the emergency room, oxygen saturation was 85, increased to 100% quickly on 100% blow-by oxygen and after 20 to 30 minutes, he was more than 95% on room air. The subject recovered and was discharged from the hospital two days later. The subject continued in the trial. The event of near miss SIDS was reported by the investigator as possibly related to the study vaccine. The next series of vaccinatinos was given on 4/2/03, including Daptacel, Poliomyelitis vaccine inactivated, HIB vaccine, Hepatitis B, and Prevnar. The subject tolerated this series. A 15-day follow up report received 8/12/2003 adds: D/C summary has been requested by Medical Affairs. From additional info received on 07/31/2003, it was reported that the subject was seen for well child exam at 2 months on 02/07/2003. After vaccinations, the child was inconsolable with periods of lethargy and apnea. An entire ER workup was done, with the results of negative CT and negative blood work (Cerebral Spinal Flud WBC 30, but RBCs 1860. The subject did not have any further episodes of this type while observed in the hospital for 3 days. The pt's vaccine reaction was likely secondary to pertussis. A pediatric infectious disease specialist was consulted, no report of this type of reaction with acellular pertussis, but it has happened with whole cell pertussis. Recommended that subject receive no further pertussis vaccines. On 04/02/2003, the pt had a four-month visit and was given IPOL, DT, Prevnar, Hib and Hepatitis B, but no pertussis. The pt was observed for 30 minutes with no reaction. The AvP Medical Monitor evaluation is that the reaction was likely anaphylaxis, which is serious, expected and related.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Apnoea, Cyanosis, Erythema, Pallor, Rash macular
Clinical narrative: This subject is a 2 month old male, who was admitted to the hospital due to near miss SIDS while enrolled in a Phase IV P3T08 study. The subject received one dose of study vaccine; the last dose prior to the event was given on 1/28/03. The subject became apneic and turned blue, shortly after immunization and was admitted to the hospital the same day. The subject required bag valve ventilation for several minutes to keep saturations within the normal range. 911 was called to the vaccination clinic. When the paramedics arrived, the subject was active and breathing on his own, but had three additional apneic spells requiring stimulation or short-term bagging until resolution. It is not known whether bradycardia accompanied his apneic spells. He did have some perioral cyanosis associated with him and cyanosis of mucous membranes. He did appear to be somewhat pale after resolution of all episodes. It was noted that the subject was developing a few red blotches on extremities and chest. Epinephrine was given prior to transport. He was transferred to the emergency room where he was evaluated and later admitted to the hospital ICU for observation. Upon arrival at the emergency room, oxygen saturation was 85, increased to 100% quickly on 100% blow-by oxygen and after 20 to 30 minutes, he was more than 95% on room air. The subject recovered and was discharged from the hospital two days later. The subject continued in the trial. The event of near miss SIDS was reported by the investigator as possibly related to the study vaccine. The next series of vaccinatinos was given on 4/2/03, including Daptacel, Poliomyelitis vaccine inactivated, HIB vaccine, Hepatitis B, and Prevnar. The subject tolerated this series. A 15-day follow up report received 8/12/2003 adds: D/C summary has been requested by Medical Affairs. From additional info received on 07/31/2003, it was reported that the subject was seen for well child exam at 2 months on 02/07/2003. After vaccinations, the child was inconsolable with periods of lethargy and apnea. An entire ER workup was done, with the results of negative CT and negative blood work (Cerebral Spinal Flud WBC 30, but RBCs 1860. The subject did not have any further episodes of this type while observed in the hospital for 3 days. The pt's vaccine reaction was likely secondary to pertussis. A pediatric infectious disease specialist was consulted, no report of this type of reaction with acellular pertussis, but it has happened with whole cell pertussis. Recommended that subject receive no further pertussis vaccines. On 04/02/2003, the pt had a four-month visit and was given IPOL, DT, Prevnar, Hib and Hepatitis B, but no pertussis. The pt was observed for 30 minutes with no reaction. The AvP Medical Monitor evaluation is that the reaction was likely anaphylaxis, which is serious, expected and related.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Apnoea, Cyanosis, Hypoxia, Pallor, Rash macular
Clinical narrative: This subject is a 2 month old male, who was admitted to the hospital due to near miss SIDS while enrolled in a Phase IV P3T08 study. The subject received one dose of study vaccine; the last dose prior to the event was given on 1/28/03. The subject became apneic and turned blue, shortly after immunization and was admitted to the hospital the same day. The subject required bag valve ventilation for several minutes to keep saturations within the normal range. 911 was called to the vaccination clinic. When the paramedics arrived, the subject was active and breathing on his own, but had three additional apneic spells requiring stimulation or short-term bagging until resolution. It is not known whether bradycardia accompanied his apneic spells. He did have some perioral cyanosis associated with him and cyanosis of mucous membranes. He did appear to be somewhat pale after resolution of all episodes. It was noted that the subject was developing a few red blotches on extremities and chest. Epinephrine was given prior to transport. He was transferred to the emergency room where he was evaluated and later admitted to the hospital ICU for observation. Upon arrival at the emergency room, oxygen saturation was 85, increased to 100% quickly on 100% blow-by oxygen and after 20 to 30 minutes, he was more than 95% on room air. The subject recovered and was discharged from the hospital two days later. The subject continued in the trial. The event of near miss SIDS was reported by the investigator as possibly related to the study vaccine. The next series of vaccinatinos was given on 4/2/03, including Daptacel, Poliomyelitis vaccine inactivated, HIB vaccine, Hepatitis B, and Prevnar. The subject tolerated this series. A 15-day follow up report received 8/12/2003 adds: D/C summary has been requested by Medical Affairs. From additional info received on 07/31/2003, it was reported that the subject was seen for well child exam at 2 months on 02/07/2003. After vaccinations, the child was inconsolable with periods of lethargy and apnea. An entire ER workup was done, with the results of negative CT and negative blood work (Cerebral Spinal Flud WBC 30, but RBCs 1860. The subject did not have any further episodes of this type while observed in the hospital for 3 days. The pt's vaccine reaction was likely secondary to pertussis. A pediatric infectious disease specialist was consulted, no report of this type of reaction with acellular pertussis, but it has happened with whole cell pertussis. Recommended that subject receive no further pertussis vaccines. On 04/02/2003, the pt had a four-month visit and was given IPOL, DT, Prevnar, Hib and Hepatitis B, but no pertussis. The pt was observed for 30 minutes with no reaction. The AvP Medical Monitor evaluation is that the reaction was likely anaphylaxis, which is serious, expected and related.
Age: 26.0
Sex: F
Vaccine: ANTH
Symptoms: Abortion spontaneous
Clinical narrative: LMP 6/25/03. Anthrax vaccine 7/16/03. Miscarriage 8/4/03.
Age: 1.0
Sex: F
Vaccine: HIBV, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: After receiving MMR and Varivax in RAT approx 3-4 minutes later immediate redness and swollen.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: DTaP given 7/28/03-mother noted swelling and erythema at site 7/30/03-continuing to enlarge at the point right thigh swollen and warm to knee. Mobility not limited. No evidence for cellulitis.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Right anterior thigh with 3 puncture sites. Erythema extending from most inferior and medial injection site. No induration, nontender to palpate.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, DTAPHEPBIP, HIBV
Symptoms: Facial palsy, Nasal congestion, Pyrexia
Clinical narrative: Vaccines given 6/18/03, that night temp up to 101, miserable, congested. Mother/father thought they saw some left-sided facial paralysis too. At 6/19/03 appt. MD states exam WNL. Mother questioned if at times still facial symptoms. Scheduled to see neuro.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, DTAPHEPBIP, HIBV
Symptoms: Facial palsy, Injection site oedema, Irritability, Pyrexia
Clinical narrative: Vaccines given 6/18/03, that night temp up to 101, miserable, congested. Mother/father thought they saw some left-sided facial paralysis too. At 6/19/03 appt. MD states exam WNL. Mother questioned if at times still facial symptoms. Scheduled to see neuro.
Age: 1.0
Sex: M
Vaccine: IPV, VARCEL
Symptoms: Rash
Clinical narrative: A per type rash present on 7/23/03. No signs of illness.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema multiforme, Rash
Clinical narrative: Mom called office with complaints of developed rash (3 spots) left shoulder, right shoulder and left lower leg-was seen in office same day and dx with erythema multiform. No rash evident prior to immunizations.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Pruritus, Urticaria, Wheezing
Clinical narrative: Hives over entire body, itching, wheezing and with some SOB.
Age: 1.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Rash papular
Clinical narrative: Low grade temp approx 48 hours after administration of MMR, then "measly" rash all over his body. These are small papules on face, trunk, extremities and diaper areas, buttocks. Feeling OK, behaving normally today.
Age: 54.0
Sex: F
Vaccine: TD
Symptoms: Muscle spasms
Clinical narrative: 8/2/03 7AM muscle spasm right thigh. 8/3/03 muscle spasm at back of right thigh 10wav extremity for approx 5-10 minutes, more intense than 8/2/03 symptoms, denies fever. 8/4/03 visit B/P 136/88, p 73, no symptoms.
Age: 11.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Pt's mother called 8/4/03 stating pt has redness and swelling around the site where the varicella injection was given. Pt denies fever or pain.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Crying, Irritability
Clinical narrative: Prolonged screaming, irritability of >1 hour duration. No recorded fever. Less responsive than usual. Follow up exam in our office normal.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Convulsion, Musculoskeletal stiffness, Tremor
Clinical narrative: Mom called and reported that child had a seizure-like episode on Sun. 7/20/03 after 12 on 7/18/03. Episode lasted 15-20 seconds. Child was conscious and talking throughout but lost balance (couldn't maintain sitting position). Body was stiff, right leg shaking. Did not seek any medical treatment at time but was visiting later in day and a asked nurse on duty about incident, who suggested it be reported as preschool 12 given 2 days to Mom. Checked temp with ear thermometer-98.4. No signs of any illness.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Urticaria
Clinical narrative: Following administration of Varivax and MMR, developed a hive at site of administration. Pt was given the above vaccines in opposing arms. And had the local red reaction in each arm. Given Benadryl po.
Age: 46.0
Sex: F
Vaccine: TD
Symptoms: Feeling hot, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Td left arm pt received 10 days ago. Still has big lump there. Warm to touch, pink, lower half of arm feels "funny". Feels like pulling a little by elbow. No soreness unless bumped. Induration about 1 cm left arm at vaccine site.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: Local reaction to left upper arm. Redness to area and patch about 5" x 3" erythema. No Tx. Necessary only observation and apply or take Benadryl.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Viral infection
Clinical narrative: Diagnosed with chickenpox (head to toe typical lesions)
Sex: U
Vaccine: DTAP
Symptoms: Erythema, Oedema
Clinical narrative: Left leg 6.5 x 5.5 inch erythema, swelling, non-tender, walking ok.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Angioneurotic oedema, Tachypnoea, Wheezing
Clinical narrative: Wheezing, angioedema, tachypnea.  In office: required albuterol, Epi-pen Jr, Benadryl.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Redness, induration, warmth at site 6x4cm.  Responded well to Keflex.
Age: 11.0
Sex: M
Vaccine: HEP, TD, VARCEL
Symptoms: Fall, Haematoma, Hyperhidrosis, Syncope
Clinical narrative: Heard a 'thump' in the hallway and came out from patient room to check.  Patient laying flat appearing dazed, minor clonic tonic movements to extremities ~ 30-40 seconds, fully conscious, no emesis/cyanosis.  Heart rate 80.  Completely responsive once twitching over and stood up with steady gait.  Mildly diaphoectic, scalp with small ~ 1.5 cm hematoma, left occiput, Heart rate 82, RR 24, blood pressure 110-80.  Right elbow with tenderness-keeping it flessed.  right elbow (independent review)-normal.  A/P syncope, following immunizations.  Cool compresses to scalp, signs of intrassanial injury including unusual sleepiness/aesoerentatrou/headache/vomiting/diptopia or other concerns.  Right arm sling for comfort.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Body temperature increased, Irritability, Rash
Clinical narrative: Diffuse rash over entire body, irritable, temperature 100.4F.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema
Clinical narrative: Red area going below elbow where vaccines were administered in right arm.
Age: 13.0
Sex: F
Vaccine: HEP, TD, VARCEL
Symptoms: Dyspnoea, Injection site erythema, Pruritus
Clinical narrative: Approximately 1 minute after getting varicella vaccine, patients arm at the site (right arm) turned red and started itching.  Administered Benadryl 50mg per mouth.  Complained of shortness of breath.  No other rashes noted.  Patient remained in health department for 20 min. after medication.  Redness was almost gone.  Patient stated it was not itching as bad.  Advised to go to ER if symptoms return or worsen.
Age: 0.4
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Erythema, Feeling hot, Rash
Clinical narrative: 3-4 minutes after immunizations, child had rash on face and legs.  Legs were solid red and hot to touch.  Gave 3mL of Childrens Benadryl per MD, child waited and was fine.
Age: 1.0
Sex: F
Vaccine: UNK
Symptoms: Rash macular, Rash papular
Clinical narrative: Maculopapular rash starting on face and progressing to trunk.  No treatment needed c/w measles vaccine associated rash.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site swelling
Clinical narrative: 3 1/2 large reddened swollen area going around th edeltoid muscle with fever.  Received one shot on this arm.  Mom said he only received one shot in this arm.
Age: 1.6
Sex: M
Vaccine: DTPIPV
Symptoms: Injection site erythema, Oedema
Clinical narrative: Child received DPaP IPV in L thigh on 6/10/03 Seen 6/12/03 and had 10x6cm swollen erythematous area L thigh.  Puncture seen in upper part of swollen area.  No apparent pain, moved leg normally, erythema fading.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain, Decreased appetite, Influenza like illness, Nausea, Petechiae
Clinical narrative: Patient developed a fever of 102.2,petechiae on his upper quadrant and vomited the evening after he recieved the first of the hepatitis shots.He also developed influenza-like symptoms that lasted over 3 weeks. He seemed to recover for a few weeks and then the symptoms returned. patient has been unable to eat without feeling severe nausea and abdominal pain. He continues to loss weight and has been seen multiple times by his physician and a pediatric G.I. specialist.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Pyrexia, Vomiting, Weight decreased
Clinical narrative: Patient developed a fever of 102.2,petechiae on his upper quadrant and vomited the evening after he recieved the first of the hepatitis shots.He also developed influenza-like symptoms that lasted over 3 weeks. He seemed to recover for a few weeks and then the symptoms returned. patient has been unable to eat without feeling severe nausea and abdominal pain. He continues to loss weight and has been seen multiple times by his physician and a pediatric G.I. specialist.
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Feeling hot, Oedema
Clinical narrative: R arm swollen after anthrax shot - 4x6cm red, warm site
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Chills, Dehydration, Headache, Hyperhidrosis, Influenza like illness
Clinical narrative: Smallpox vaccination,Anthrax #1, Typhoid,Hepatitis B #2. 24 July 2003 Received primary smallpox vaccination in his left arm via 3 jabs.  No contraindications to smallpox.  Received the smallpox briefing and brochure.Also received the other 3 vaccinations in his right arm.  He had no complaints on this day ("felt fine").   2 Aug 2003 Started developing fever (subjective) and chills alternating with sweats.  "Didn't feel up to normal activities."  "Felt dehydrated."  Mild to moderate headache.  No vision changes.  No neck discomfort.  No chest pain or dyspnea.  Vaccination site had slight drainage and there was erythema starting to develop around smallpox vaccination site (approximately 1 inch).No complaints regarding vaccination sites in right arm.  3 Aug 2003 Continuation of flu-like symptoms and erythematous circle growing around site.  Now noted that the erythematous circle had expanded around shoulder and to approximately 3 inches above elbow.  Noted tenderness under left arm-"it felt tight if I moved my arm."  8/4/03 Flu-like symptoms decreasing but noted increasing erythema and had extended to approximately 2 inches from elbow.  Area not pruritic.  Smallpox vaccination site with slight drainage.  Presented to the clinic for evaluation.  MD referred. He was diagnosed with having a robust take, prescribed Ibuprofen, Tylenol, and Benadryl, and referred to another MD.  8/5/03 Evaluation.  Flu-like symptoms almost completely resolved.  Reports erythema is "lighter" but now has extended down to antecubital area.  Had not noted any other lesions but then at visit, noted several erythematous macular-papular lesions on chest and back.  Non-pruritc.  Denies noticing these lesions previously and does not remember ever having these lesions in previous episodes. Diagnosed with Robust take and Non-viral pustulosis.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site erythema, Pyrexia, Rash maculo-papular, Tenderness
Clinical narrative: Smallpox vaccination,Anthrax #1, Typhoid,Hepatitis B #2. 24 July 2003 Received primary smallpox vaccination in his left arm via 3 jabs.  No contraindications to smallpox.  Received the smallpox briefing and brochure.Also received the other 3 vaccinations in his right arm.  He had no complaints on this day ("felt fine").   2 Aug 2003 Started developing fever (subjective) and chills alternating with sweats.  "Didn't feel up to normal activities."  "Felt dehydrated."  Mild to moderate headache.  No vision changes.  No neck discomfort.  No chest pain or dyspnea.  Vaccination site had slight drainage and there was erythema starting to develop around smallpox vaccination site (approximately 1 inch).No complaints regarding vaccination sites in right arm.  3 Aug 2003 Continuation of flu-like symptoms and erythematous circle growing around site.  Now noted that the erythematous circle had expanded around shoulder and to approximately 3 inches above elbow.  Noted tenderness under left arm-"it felt tight if I moved my arm."  8/4/03 Flu-like symptoms decreasing but noted increasing erythema and had extended to approximately 2 inches from elbow.  Area not pruritic.  Smallpox vaccination site with slight drainage.  Presented to the clinic for evaluation.  MD referred. He was diagnosed with having a robust take, prescribed Ibuprofen, Tylenol, and Benadryl, and referred to another MD.  8/5/03 Evaluation.  Flu-like symptoms almost completely resolved.  Reports erythema is "lighter" but now has extended down to antecubital area.  Had not noted any other lesions but then at visit, noted several erythematous macular-papular lesions on chest and back.  Non-pruritc.  Denies noticing these lesions previously and does not remember ever having these lesions in previous episodes. Diagnosed with Robust take and Non-viral pustulosis.
Age: 44.0
Sex: F
Vaccine: SMALL
Symptoms: Arthritis, Asthenia, Fatigue, Pain, Rash
Clinical narrative: One week after vaccination, pt presented to Dr  with rash on right wrist and small lesion on the back.  The lesion did not look like a vesicule.  A few days after Dr visit, pt stated that the lesion broke and fluid came out. Pt presents again to Dr Aug 8, 2003 with complaints of arthritic pain. Indicated a week after lesion broke, pt began (and continues)to be tired and weak; muscles are tender to palpation and has general fatigue. EKG, chest x-ray and other labs ordered.  Dr realizes that smallpox vaccine given several months ago, but due to concern heart condition called UDOH to report the case.  UDOH also referred Dr to the clinical information line for more clinical assistance.
Age: 44.0
Sex: F
Vaccine: SMALL
Symptoms: Rash pustular
Clinical narrative: One week after vaccination, pt presented to Dr  with rash on right wrist and small lesion on the back.  The lesion did not look like a vesicule.  A few days after Dr visit, pt stated that the lesion broke and fluid came out. Pt presents again to Dr Aug 8, 2003 with complaints of arthritic pain. Indicated a week after lesion broke, pt began (and continues)to be tired and weak; muscles are tender to palpation and has general fatigue. EKG, chest x-ray and other labs ordered.  Dr realizes that smallpox vaccine given several months ago, but due to concern heart condition called UDOH to report the case.  UDOH also referred Dr to the clinical information line for more clinical assistance.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Dyskinesia, Eye movement disorder, Headache, Nausea, Syncope
Clinical narrative: After pt. received vaccine, pt became faint, eyes rolled, arms had jerky movements for 30 sec.  Pt lost consciousness.  Vitals checked.  Pt c/o nausia, servere headache.  A&O x 4, called, pt sent to hospital per ambulance
Age: 1.0
Sex: M
Vaccine: HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: Patient received PPD, HIB#4, and Pneumo#4 in the morning and in the middle of that night development high fever 104-105.8.
Age: 5.0
Sex: F
Vaccine: DTP, IPV, MMR
Symptoms: Injection site inflammation, Rash erythematous, Tenderness
Clinical narrative: Round, red, raised, tender area about 6" around area of inflammation was found at injection site.  Notified MD and was seen next day on May 31, 2003.  MD determined this was an adverse reaction to Whooping cough vaccine and not cellulitis.
Age: 0.4
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Pyrexia, Rash, Somnolence
Clinical narrative: FEVER, RASH,EXCESSIVE SLEEPING,CALLED NURSE AND ASSURED ME THIS WAS NORMAL A REACTION. WHEN MY CHILD CONTINUED TO GET WORSE I CALLED THE DOCTORS OFFICE BACK AND INSISTED HE BE SEEN AND CHECKED OUT SO SHE TOLD ME TO BRING HIM INTO THE OFFICE.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Anorexia, Cyanosis, Dehydration, Diarrhoea, Gastroenteritis
Clinical narrative: This report was received for diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid and hepatitis B vaccine recombinant and was assigned manufacturer report number A0417640A. It was reported that a 57 day old female with no concurrent conditions or relevant medical history was vaccinated with a dose of hepatitis B virus vaccine on 11/1/02. Suspect vaccinations on the same day included a first dose of Haemophilus B conjugate vaccine, a first dose of diphtheria toxoid/pertussis vaccine/tetanus toxoid, a dose of Streptococcus pneumoniae vaccine and a first dose of poliovirus vaccine. On 11/2/02 the patient experienced heavy vomiting with the inability to keep down fluids, lethargy, diarrhea and heavy urination. The patient was hospitalized for seven days. Subsequently, the events resolved. The reporter indicated that the patient's physician considered the events to be caused by the diphtheria toxoid/pertussis vaccine/tetanus toxoid vaccine and the series was discontinued. This was originally reported by a consumer, the patient's mother. No further information provided. Follow up on 09/30/2003: "From additional information received on 09/15/2003 from Merck (reference number WAES 0307USA03642), it was reported that the patient was seen by a physician and was hospitalized for seven days.  She has since recovered.  The reporter indicated that the patient's physician considered the events to be caused by the diphtheria toxoid/pertussis vaccine/tetanus toxoid vaccine and the series was discontinued.  No further information was provided."
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Insomnia, Lethargy, Somnolence, Vomiting
Clinical narrative: This report was received for diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid and hepatitis B vaccine recombinant and was assigned manufacturer report number A0417640A. It was reported that a 57 day old female with no concurrent conditions or relevant medical history was vaccinated with a dose of hepatitis B virus vaccine on 11/1/02. Suspect vaccinations on the same day included a first dose of Haemophilus B conjugate vaccine, a first dose of diphtheria toxoid/pertussis vaccine/tetanus toxoid, a dose of Streptococcus pneumoniae vaccine and a first dose of poliovirus vaccine. On 11/2/02 the patient experienced heavy vomiting with the inability to keep down fluids, lethargy, diarrhea and heavy urination. The patient was hospitalized for seven days. Subsequently, the events resolved. The reporter indicated that the patient's physician considered the events to be caused by the diphtheria toxoid/pertussis vaccine/tetanus toxoid vaccine and the series was discontinued. This was originally reported by a consumer, the patient's mother. No further information provided. Follow up on 09/30/2003: "From additional information received on 09/15/2003 from Merck (reference number WAES 0307USA03642), it was reported that the patient was seen by a physician and was hospitalized for seven days.  She has since recovered.  The reporter indicated that the patient's physician considered the events to be caused by the diphtheria toxoid/pertussis vaccine/tetanus toxoid vaccine and the series was discontinued.  No further information was provided."
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Diarrhoea, Lethargy, Pollakiuria, Vomiting
Clinical narrative: This report was received for diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid and hepatitis B vaccine recombinant and was assigned manufacturer report number A0417640A. It was reported that a 57 day old female with no concurrent conditions or relevant medical history was vaccinated with a dose of hepatitis B virus vaccine on 11/1/02. Suspect vaccinations on the same day included a first dose of Haemophilus B conjugate vaccine, a first dose of diphtheria toxoid/pertussis vaccine/tetanus toxoid, a dose of Streptococcus pneumoniae vaccine and a first dose of poliovirus vaccine. On 11/2/02 the patient experienced heavy vomiting with the inability to keep down fluids, lethargy, diarrhea and heavy urination. The patient was hospitalized for seven days. Subsequently, the events resolved. The reporter indicated that the patient's physician considered the events to be caused by the diphtheria toxoid/pertussis vaccine/tetanus toxoid vaccine and the series was discontinued. This was originally reported by a consumer, the patient's mother. No further information provided. Follow up on 09/30/2003: "From additional information received on 09/15/2003 from Merck (reference number WAES 0307USA03642), it was reported that the patient was seen by a physician and was hospitalized for seven days.  She has since recovered.  The reporter indicated that the patient's physician considered the events to be caused by the diphtheria toxoid/pertussis vaccine/tetanus toxoid vaccine and the series was discontinued.  No further information was provided."