chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.75
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration, Intussusception
Clinical narrative: Initial report received on 23 May 2007 from another manufacturer, report# WAES0705USA03217. The initial reporter to this manufacturer had been the FDA, VAERS# 278006. Verbatim from the report: "Information has been received from the FDA (VAERS # 278006) through the CDC concerning a 9-month-old female with no history or pre-existing conditions who on 29-DEC-2006 was vaccinated with a third dose of Rotateq (Lot # 655866/1110F). Concomitant vaccinations that day included a dose of DAPTACEL (Lot # U1965AB), a third dose of Recombivax HB (Lot # 652402/0032F), a third dose of ACTHIB (Lot # UF018AD), a third dose of IPOL (Lot # Y10312), and a third dose of PREVNAR (Lot # B08646C). There were no other medications. On 26-APR-2007, 118 days post vaccination, the patient experienced intussusception and was hospitalized. Subsequently, the patient recovered. Additional information has been requested. ActHIB lot number UF018AD corresponds to sanofi pasteur ltd. lot number Z0879-2. IPOL lot number Y10312 is not a valid sanofi pasteur lot number.
Age: 84.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Rash pruritic
Clinical narrative: After a few days of the vax developed rashes, itching in the right side of power back. Went to see Dr. He confirmed that it was shingles. Rep to hosp and Merck.
Age: 84.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Pruritus, Rash
Clinical narrative: After a few days of the vax developed rashes, itching in the right side of power back. Went to see Dr. He confirmed that it was shingles. Rep to hosp and Merck.
Age: 84.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Discomfort, Herpes zoster, Pruritus, Rash
Clinical narrative: After a few days of the vax developed rashes, itching in the right side of power back. Went to see Dr. He confirmed that it was shingles. Rep to hosp and Merck.
Age: 18.0
Sex: M
Vaccine: JEV, JEV
Symptoms: Dyspepsia, Pharyngolaryngeal pain, Rash pruritic, Throat tightness
Clinical narrative: This case was received from a health professional on 28 May 2007. SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. An 18-year-old male patient with no known medical conditions or allergies had received an injection of JE-VAX on 10 May 2007, and 19 days later developed throat closing, chest discomfort, and rash. The patient had received dose one of JE-VAX on 10 April 2007, dose two on 17 April 2007, and dose three on 10 May 2007. On 28 May 2007 he presented to the emergency room with complaints of a rash which had developed on his stomach and neck and spread to his entire body; he also complained of throat closing and chest discomfort described as "severe heartburn". He was treated with Benadryl, and at the time of the report had not yet recovered.
Age: 18.0
Sex: M
Vaccine: JEV, JEV
Symptoms: Chest discomfort, Dyspepsia, Rash, Throat tightness
Clinical narrative: This case was received from a health professional on 28 May 2007. SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. An 18-year-old male patient with no known medical conditions or allergies had received an injection of JE-VAX on 10 May 2007, and 19 days later developed throat closing, chest discomfort, and rash. The patient had received dose one of JE-VAX on 10 April 2007, dose two on 17 April 2007, and dose three on 10 May 2007. On 28 May 2007 he presented to the emergency room with complaints of a rash which had developed on his stomach and neck and spread to his entire body; he also complained of throat closing and chest discomfort described as "severe heartburn". He was treated with Benadryl, and at the time of the report had not yet recovered.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Aplastic anaemia, Aspiration bone marrow, Biopsy bone marrow, Contusion, Fatigue
Clinical narrative: In early May, increased bruising, slower wound healing, severe bleeding with menstruation, intermittent headaches, fatigue. Admitted to medical center on 06/01/07 following referred from primary pediatrician with pancytopenia. Diagnosed with aplastic anemia. Treatment to be determined. 6/21/07-records received for DOS 6/1-6/5/07-DC DX: Severe pancytopenia. status post transfusion of RBC times 2 and platelets times 1. Seen in ER on 6/1/07 for increased bruising and pancytopenia on her blood smear. No evidence of ITP. Severe aplastic anemia.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count, Headache, Impaired healing, Menorrhagia, Pancytopenia
Clinical narrative: In early May, increased bruising, slower wound healing, severe bleeding with menstruation, intermittent headaches, fatigue. Admitted to medical center on 06/01/07 following referred from primary pediatrician with pancytopenia. Diagnosed with aplastic anemia. Treatment to be determined. 6/21/07-records received for DOS 6/1-6/5/07-DC DX: Severe pancytopenia. status post transfusion of RBC times 2 and platelets times 1. Seen in ER on 6/1/07 for increased bruising and pancytopenia on her blood smear. No evidence of ITP. Severe aplastic anemia.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Viral test
Clinical narrative: In early May, increased bruising, slower wound healing, severe bleeding with menstruation, intermittent headaches, fatigue. Admitted to medical center on 06/01/07 following referred from primary pediatrician with pancytopenia. Diagnosed with aplastic anemia. Treatment to be determined. 6/21/07-records received for DOS 6/1-6/5/07-DC DX: Severe pancytopenia. status post transfusion of RBC times 2 and platelets times 1. Seen in ER on 6/1/07 for increased bruising and pancytopenia on her blood smear. No evidence of ITP. Severe aplastic anemia.
Age: 21.0
Sex: F
Vaccine: HEPA, HPV4, TD
Symptoms: Immediate post-injection reaction, Nausea, Presyncope
Clinical narrative: 1. (L) arm Hep A then Td 2. (L) arm Gardasil Immediate onset of nausea and pre syncopal symptoms, BP 80/60 Improved within 10 min lying down
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a physician concerning a 8 week old male on 22-MAR-2007 was vaccinated with 2 ml dose of Rotateq. On 01-APR-2007, the patient experienced blood in the stool. The patient sought unspecified medical attention. Subsequently, the patient recovered from blood in the stool. Upon internal review blood in stool was determined to be an other important medical event. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: MU
Symptoms: Convulsion, Lymphadenopathy, Testicular pain
Clinical narrative: Information has been received from a male consumer, concerning himself, with no medical history or allergies, who "as a child" was vaccinated with a dose of Mumpsvax. There were no concomitant medication. It was reported that the patient experienced two seizures, "one about six years ago and one about four days ago, date approximate". Prior to the seizures, it was reported that "there was pain in his testis". Recently, he has had "what may be gland swelling in his neck". No lab diagnostic studies were performed. No medical attention was sought. No product quality complaint was involved. The patients' adverse events were considered to be other important medical events. Additional information has been requested.
Sex: U
Vaccine: DTAP
Symptoms: Death
Clinical narrative: This case was received from a consumer on 22 May 2007. A consumer reported that "her friend's child died from a DPT shot". No additional information was provided.
Sex: M
Vaccine: MNQ
Symptoms: Congenital anomaly, Drug exposure during pregnancy, Polydactyly
Clinical narrative: Initial report received from a health care professional on 25 May 2007. A male patient was exposed to Menactra, lot number U1874A, transplacentally on 5 September 2006 during the mother's pregnancy at 13 weeks gestation. The mother's last menstrual period date was 20 May 2006. The patient was delivered via C-section and was found to have an extra digit on each hand. As per the reporter, there were no pregnancy complications and no complications of labor and delivery. No information regarding medical intervention or recovery status was reported. This case is linked to case 2006-02349, which involved the non-serous event of anemia in the patient's mother during pregnancy.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Body temperature increased, Irritability
Clinical narrative: Patient developed temp to 105 deg about 12 hours after receiving ProQuad. He also was irritable.
Sex: M
Vaccine: VARCEL
Symptoms: Cough, Dyspnoea, Oxygen saturation, Pharyngolaryngeal pain, Rash
Clinical narrative: Patient began to cough, c/o throat pain, difficulty breathing, rash on trunk, wheezing, pulse ox on Room air 93.7. Give SQ epi-nephrine 0.3 ml x 1 (1:1000)
Sex: M
Vaccine: VARCEL
Symptoms: Wheezing
Clinical narrative: Patient began to cough, c/o throat pain, difficulty breathing, rash on trunk, wheezing, pulse ox on Room air 93.7. Give SQ epi-nephrine 0.3 ml x 1 (1:1000)
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Nausea
Clinical narrative: 05/15/07 Pt states had nausea, H/A and chills approx 6 hrs after immunization no site redness or swelling. States felt fine approx 10am next day (5/16/07
Age: 30.0
Sex: M
Vaccine: HEP, IPV, MMR, TDAP
Symptoms: Injection site erythema, Injection site swelling, Loss of consciousness, Pallor, Syncope
Clinical narrative: Client became pale, fainted approx 5 sec unconscious easily aroused. Tdap inject site red, swollen, raised area 6" x 4 1/2". Ice applied area decreased to 2" x 3" by discharge from clinic. States received tetanus years ago as wound care - no problem- ? Pertussis in Tdap.
Sex: M
Vaccine: TDAP
Symptoms: Blood culture, Blood urea, Full blood count, Influenza serology, Laboratory test
Clinical narrative: 102 deg fever, body aches, swollen lips, felt really sick.
Sex: M
Vaccine: TDAP
Symptoms: Lip swelling, Malaise, Pain, Pyrexia, Streptococcal identification test
Clinical narrative: 102 deg fever, body aches, swollen lips, felt really sick.
Sex: M
Vaccine: TDAP
Symptoms: Urine analysis
Clinical narrative: 102 deg fever, body aches, swollen lips, felt really sick.
Age: 71.0
Sex: U
Vaccine: PPV
Symptoms: Heat therapy, Rash erythematous, Skin warm, Tenderness
Clinical narrative: Warm tender, erythematous rash two days after Pneumovax Ix. heating pad, tylenol, NSAIDS
Age: 66.0
Sex: U
Vaccine: PPV
Symptoms: Cold compress therapy, Heat therapy, Induration, Rash erythematous, Skin warm
Clinical narrative: Indurated, tender, warm erythematous rash. Treated with heat, ice, NSAIDS and tylenol. Then tx with Keflex empirically
Age: 66.0
Sex: U
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Indurated, tender, warm erythematous rash. Treated with heat, ice, NSAIDS and tylenol. Then tx with Keflex empirically
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Biopsy, Pruritus, Rash, Rash pruritic
Clinical narrative: Zostavax administered 05/10/2007. 05/15/2007 rash, itchy, appeared along left jaw line, forearm on right arm; right chest. Scattered itchy, red, raised pustules in appearance. Doctor took biopsy. Determined reaction to vaccine.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pustular
Clinical narrative: Zostavax administered 05/10/2007. 05/15/2007 rash, itchy, appeared along left jaw line, forearm on right arm; right chest. Scattered itchy, red, raised pustules in appearance. Doctor took biopsy. Determined reaction to vaccine.
Age: 1.83
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: none stated
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Cold compress therapy, Induration, Injection site erythema, Skin warm
Clinical narrative: Redness at (R) upper arm at injection site started 6/1/07-size of 2 quarters. Redness spread 8 x 10" indurated warm to touch by 6/2/07 (circled in ink). Motrin, cool compress.
Age: 9.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Pt. rec. vaccine on the afternoon of 5/29/07 the morning of 5/30/07 there was a small area of redness, by that afternoon, pt complaining of pain and area swollen to 2" x 2" diameter with redness
Sex: F
Vaccine: MMR
Symptoms: Erythema, Headache, Lacrimation increased, Lethargy, Swelling face
Clinical narrative: Within approx 20 min. pt complained of severe headache, vomited, became lethargic and then developed red, watery eyes, puffy face and covered in hives. Resolved after few hours with steroids and antihistamines.
Sex: F
Vaccine: MMR
Symptoms: Urticaria, Vomiting
Clinical narrative: Within approx 20 min. pt complained of severe headache, vomited, became lethargic and then developed red, watery eyes, puffy face and covered in hives. Resolved after few hours with steroids and antihistamines.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Decreased appetite, Erythema, Pain, Pharyngeal oedema
Clinical narrative: Pt experienced fever 100.4, muscle, joint weakness and pain,tongue and throat swollen and white coated, redness and tenderness below I.M. site. Decreased appetite. Symptoms began P.M. following injection. Pt feeling better on 6-5-7
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Swollen tongue, Tenderness
Clinical narrative: Pt experienced fever 100.4, muscle, joint weakness and pain,tongue and throat swollen and white coated, redness and tenderness below I.M. site. Decreased appetite. Symptoms began P.M. following injection. Pt feeling better on 6-5-7
Age: 18.0
Sex: F
Vaccine: MNQ, TD, YF
Symptoms: Chest discomfort, Cold sweat, Dizziness, Dry mouth, Dyspnoea
Clinical narrative: Patient left the facility not feeling well - lightheaded, dizzy.  Within 10 minutes, she was having difficulty breathing with dry mouth, heavy chest and swelling throat.  Other symptoms were nausea, extremely white/pale with clammy skin, jello arms and legs.  I spoke with the doctor's office and a family friend who is a nurse.  We had patient drink a sugar drink and rest with cold compresses.  Her symptoms improved over the next 3 hours, and we are continuing to monitor her.
Age: 18.0
Sex: F
Vaccine: MNQ, TD, YF
Symptoms: Malaise, Muscular weakness, Nausea, Pallor, Pharyngeal oedema
Clinical narrative: Patient left the facility not feeling well - lightheaded, dizzy.  Within 10 minutes, she was having difficulty breathing with dry mouth, heavy chest and swelling throat.  Other symptoms were nausea, extremely white/pale with clammy skin, jello arms and legs.  I spoke with the doctor's office and a family friend who is a nurse.  We had patient drink a sugar drink and rest with cold compresses.  Her symptoms improved over the next 3 hours, and we are continuing to monitor her.
Age: 29.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Contusion, Feeling abnormal, Haematoma, Pyrexia, Rash
Clinical narrative: Patient received Hep B vaccine and MMR vaccine on Monday, May 21, 2007. By the next day, she began to feel "bad" and have fever. By Friday, May 25, 2007, she found a rash on her legs and bruises/hematomas all over her body. She went an emergency department where she was admitted to hospital x 4 days. She was treated with transfusions and steroids and discharged with a diagnosis of "immune thrombocytopenic purpura" by pt. report. Patient came to our office on 6-05 when she looked well, but some bruising remained. 9/21/07-records received for DOS 5/25-5/28/07. DC DX: Immune thrombocytopenia probably secondary to measles, mumps, rubella vaccination. C/O bruising and multiple rashes over bilateral extremities. PE: Petechial rashes on lower extremities, bruises with ecchymosis over bilateral hip area and elbows.
Age: 29.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Thrombocytopenic purpura
Clinical narrative: Patient received Hep B vaccine and MMR vaccine on Monday, May 21, 2007. By the next day, she began to feel "bad" and have fever. By Friday, May 25, 2007, she found a rash on her legs and bruises/hematomas all over her body. She went an emergency department where she was admitted to hospital x 4 days. She was treated with transfusions and steroids and discharged with a diagnosis of "immune thrombocytopenic purpura" by pt. report. Patient came to our office on 6-05 when she looked well, but some bruising remained. 9/21/07-records received for DOS 5/25-5/28/07. DC DX: Immune thrombocytopenia probably secondary to measles, mumps, rubella vaccination. C/O bruising and multiple rashes over bilateral extremities. PE: Petechial rashes on lower extremities, bruises with ecchymosis over bilateral hip area and elbows.
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Culture stool, Diarrhoea, Gastroenteritis rotavirus, Rotavirus test, Vomiting
Clinical narrative: child with vomiting and diarrhea from 5/22/2007.  Seen 5/23/2007 with negative rotovirus.  Seen 6/05/2007 an positive rotovirus
Age: 22.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Pallor, Rash
Clinical narrative: Patient seen by MD on 5/3/07, 5/5/07 and 5/8/07 for raised, erythematous, blanching rash on neck, torso and arms. No other symptoms. 5/10/07 follow up phone call, pt reported rash had not resolved, but was not worsening.
Age: 12.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Body temperature increased, Erythema, Pruritus, Rash, Somnolence
Clinical narrative: Got shot at 11:15, went out to lunch and for a haircut, about 2:00 pm c/o extreme itching on upper thighs and Mom discovered an angry bright red raised rash that mottled and began all joining together into one large solid welt covering the thighs bilaterally from hip to knee. Took him to the pediatrician immediately and by then the rash existed on both forearms and the forehead in addition to the thighs. Given 4 fast melt tablets of Benadryl (adult dose since weight 110 lbs) and observed for 45 minutes in doctor's office. Temp was 100 degrees. Examined by Drs and allowed to go home after rash subsided. Parents instructed to give Benadryl q 4-6 hours for the next four days. Mother reports on 6/6/07 that some redness was starting again last night but went away after Benadryl was administered. Patient is sleepy from the Benadryl but is doing well.
Age: 12.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Urticaria
Clinical narrative: Got shot at 11:15, went out to lunch and for a haircut, about 2:00 pm c/o extreme itching on upper thighs and Mom discovered an angry bright red raised rash that mottled and began all joining together into one large solid welt covering the thighs bilaterally from hip to knee. Took him to the pediatrician immediately and by then the rash existed on both forearms and the forehead in addition to the thighs. Given 4 fast melt tablets of Benadryl (adult dose since weight 110 lbs) and observed for 45 minutes in doctor's office. Temp was 100 degrees. Examined by Drs and allowed to go home after rash subsided. Parents instructed to give Benadryl q 4-6 hours for the next four days. Mother reports on 6/6/07 that some redness was starting again last night but went away after Benadryl was administered. Patient is sleepy from the Benadryl but is doing well.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Blood culture, Chills, Dizziness, Nausea, Pyrexia
Clinical narrative: Pt received immunization on 30 MAY. Awoke the following morning with fever(101), chills, dizziness, nausea and vomiting which did not resolve after 24hrs.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Pt received immunization on 30 MAY. Awoke the following morning with fever(101), chills, dizziness, nausea and vomiting which did not resolve after 24hrs.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Barium double contrast, Intussusception, Ultrasound abdomen abnormal, X-ray abnormal
Clinical narrative: ER 05/06/07 abnl x-ray abdomen; 05/7/07 Us abdomen 'findings highly suggestive of ileocolic intussusception. tx 'Air reduction.' 06/07/07-rcords received from facility for DOS 5/8-5/11/07-DC DX: Intussusception. One day history of emesis, nonbilious, nonbloody and multiple episodes of diarrhea with no blood no mucus. Refusing to eat. Seen in ER.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium double contrast, Diarrhoea, Diet refusal, Flatulence, Intussusception
Clinical narrative: ER 05/06/07 abnl x-ray abdomen; 05/7/07 Us abdomen 'findings highly suggestive of ileocolic intussusception. tx 'Air reduction.' 06/07/07-rcords received from facility for DOS 5/8-5/11/07-DC DX: Intussusception. One day history of emesis, nonbilious, nonbloody and multiple episodes of diarrhea with no blood no mucus. Refusing to eat. Seen in ER.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Ultrasound abdomen abnormal, Vomiting, X-ray abnormal
Clinical narrative: ER 05/06/07 abnl x-ray abdomen; 05/7/07 Us abdomen 'findings highly suggestive of ileocolic intussusception. tx 'Air reduction.' 06/07/07-rcords received from facility for DOS 5/8-5/11/07-DC DX: Intussusception. One day history of emesis, nonbilious, nonbloody and multiple episodes of diarrhea with no blood no mucus. Refusing to eat. Seen in ER.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Abdominal mass, Barium double contrast, Barium enema, Diarrhoea
Clinical narrative: ER 05/06/07 abnl x-ray abdomen; 05/7/07 Us abdomen 'findings highly suggestive of ileocolic intussusception. tx 'Air reduction.' 06/07/07-rcords received from facility for DOS 5/8-5/11/07-DC DX: Intussusception. One day history of emesis, nonbilious, nonbloody and multiple episodes of diarrhea with no blood no mucus. Refusing to eat. Seen in ER.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: ER 05/06/07 abnl x-ray abdomen; 05/7/07 Us abdomen 'findings highly suggestive of ileocolic intussusception. tx 'Air reduction.' 06/07/07-rcords received from facility for DOS 5/8-5/11/07-DC DX: Intussusception. One day history of emesis, nonbilious, nonbloody and multiple episodes of diarrhea with no blood no mucus. Refusing to eat. Seen in ER.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Apnoea, Culture negative, Cyanosis
Clinical narrative: On 6-4-07 at 10:00 a.m. patient received two month vaccines.  Went home and at 8:00 that evening pt. had severe apnic events with color changes which required hospitalization including septic workup.  As of 6-6-07 pt. still in hospital. All cultures negative and patient improving.  Plan probable discharge in the next couple of day.  6/12/07 Received hospital medical records which reveal patient experienced pauses in breathing w/accompanying pallor, lethargy.  Brought to ER where O2sats were 100% on RA w/exam WNL but was admitted for observation as patient had only been d/c from NICU 5 days prior to readmission. Admitted 6/4-6/7/07.  Family instructed to not give pertussis to patient again but all other family members were to have pertussis vax or booster. FINAL DX: apnea, O2 desats & bradycardic events; GERD resolved; sepsis ruled out.  7/17/07 Received pcp vax record & office notes which confirms RO dose & lot number as reported.  Office note indicates patient doing well on day of vax.
Age: 28.0
Sex: F
Vaccine: HEP, TTOX, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Varicella
Clinical narrative: Patient was given Varivax(Merck) on 6/5/2007. On 6/6/2007 she developed a circular swelling measuring 7x3 cm on her arm where it was given. It is red and hot. She has no other symptoms.
Age: 0.8
Sex: M
Vaccine: HBHEPB
Symptoms: Injection site haematoma, Injection site swelling
Clinical narrative: IMMEDIATE SWELLING WITH INJECTION, SUSPECT HEMATOMA. ICE AND PRESSURE APPLIED.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Vomiting
Clinical narrative: severe headache and vomiting starting about 18-20 hrs after immunization, given 500ml NS bolus and Zofran by ER
Age: 40.0
Sex: F
Vaccine: ANTH
Symptoms: Headache, Injection site erythema, Injection site induration, Muscle contractions involuntary
Clinical narrative: severe headache, fasciculations in both arms. Induration and erythema at site of injection.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Fatigue, Joint swelling
Clinical narrative: after 1 day I had the vaccine I start to feel tired and my joints became swollen and I had aches in all the joints of my upper body.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Blood electrolytes, Convulsion, Electroencephalogram, Pallor, Protein total
Clinical narrative: The child immediately became pale and went into a seizure at the completion of the vaccines administrations-while applying band aids lasted < 1 min
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Erythema multiforme
Clinical narrative: Onset of erythema multiforme dx 6/6/07 No other source for infection found; only med-Tylenol x 1 dose on evening of vaccination.
Age: 15.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Discomfort, Pruritus
Clinical narrative: Pt instructed to apply warm moist compresses QID for discomfort, OTC Benadryl cream for itch.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Pt was seen for a physical 6-1-07. Mom is a CMA in the lab at our facility; she states that 6-3-07 pt had a "25mm x 25 mm" "hard, red area at the sit eof the (ProQuad) injection'. Mom also denied further react. respiratory distress or any pn or pruritus. Mom was advised to bring child in to check area mom declined; she states that the area "almost gone with on problems, no fever, no pn. "PA here at the clinic is aware of pt and situation. "Advised to not ask as mom stated and report reaction/sx as adverse reaction to vaccine.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia, Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: Red rash on face, head, neck, chest and back. Was itchy to him, had a little fever (99.6) and was warm to the touch.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling and erythema L deltoid area with slight tenderness
Sex: M
Vaccine: ANTH, TYP
Symptoms: Erythema, Induration, Pruritus
Clinical narrative: 2nd anthrax shot - rt upper arm hard bump, itched, reddened area.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Body temperature increased, Hyperhidrosis, Hypersomnia, Nausea, Pallor
Clinical narrative: (translation) high temperature 101.4, not hungry, sleeping more than usual, pale, nausea, excessive sweaty hands was taken to the pediatrician and was recommended to be evaluated by neurologist. At the moment of the interview he looks alert, looks well-neurologically speaking, with good color evaluation was made by Dr.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Crying, Gaze palsy, Similar reaction on previous exposure to drug, Somnolence, Unresponsive to stimuli
Clinical narrative: at 2m of age gave shots, pt immediately cried for 1/2 sec dad picked him up then imm. went in to a deep sleep for 40 min, only response to painful stimuli. Eyes rolling in back of head - same exact thing happened at 4 mos of age.
Age: 0.67
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, Rash generalised
Clinical narrative: [translation] rash in the whole body.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Lethargy, Rash
Clinical narrative: Information has been received from a physician regarding his 18 month old niece who on 01-APR-2006 was vaccinated with Vaqta 0.5 mL/25 U intramuscularly. On 08-APR-2006 the patient experienced a rash. On 09-APR-2006 the patient was lethargic. The child's pediatrician was contacted by her parents and they were told to have the child seen in the emergency room. The pediatrician felt the events were unrelated to vaccination. The reporting physician family member felt that lethargy and rash were possibly related to therapy with Vaqta. No further information is available.
Age: 0.5
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, Nausea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 6 month old female (also reported as 8 months old) with a history of reactive airway disease and umbilical hernia and no allergies who on 18-APR-2006 was vaccinated with Vaqta (Lot # 652090/1070R) 0.5 ml intramuscularly. No concomitant medications. On 18-APR-2006, the patient inadvertently received 3 doses of Vaqta of 0.5 ml. No other other vaccines were administered at the visit. No labs were required. No adverse reaction noted at the time or today (19-APR-2006). No further information was available at the time of reporting. Additional information was received from the physician. On 18-APR-2006, the patient received Vaqta (lot number 652508/1194R previously reported as 652090/1070R) IM in left and right thigh at 1600 hours. The patient had not received previous doses of hepatitis A virus vaccine inactivated. On 21-APR-2006, the child experienced mild nausea and vomiting lasting approximately 48 hours. On 22-APR-2006, the patient recovered. No additional information is expected.
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Vomiting
Clinical narrative: Information has been received from a certified medical assistant concerning a 5 year old 8 month old male who on 22-MAY-2006 was vaccinated with second dose of hepatitis A virus  vaccine inactivated (lot number 653616/0201F) 0.5 ml IM into left deltoid. The first dose was given on 04-AUG-2005. The patient had no illness at the time of the vaccination. It was reported that, on 22-MAY-2006, the patient vomited within 1/2 hour of receiving hepatitis A virus vaccine inactivated. At the time of reporting, the patient was recovering. Additional information was received from the certified medical assistant who reported that the child was hospitalized and has since recovered. Additional information was received from the certified medical assistant. It was reported that on 22-MAY-2006 at 1130 hours, the patient started vomiting with 30 to 40 minutes of the vaccination and was taken to the emergency room by the mother. The patient was observed and was doing fine (previously reported as hospitalized). On 22-MAY-2006, the patient recovered. No additional information is expected.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Eyelid disorder, Face oedema
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 24 month old female (weight 25#, height 33") medical history and drug reactions/allergies reported as none (previously not reported) who on 08-MAY-2006 was vaccinated with Vaqta (lot #652508/1194R). Concomitant medication included albuterol sulfate (previously not reported). On 09-MAY-2006, the patient experienced right side facial edema and right upper eyelid drainage (previously reported as swelling in her face). On 16-MAY-2006, the patient recovered from the right side facial edema and right upper eyelid drainage (previously reported as the patient's swelling in her face persisted). The physician considered the events to be non-serious and not related to therapy with Vaqta. The patient sought unspecified medical attention. No product quality complaint was involved. Additional information is not expected.
Age: 48.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Blood alkaline phosphatase increased, Body temperature increased, Diarrhoea, Hepatic enzyme abnormal, Hepatic function abnormal
Clinical narrative: Information has been received from a physician and the consumer a 48 year old female who on 01-MAY-2006 was vaccinated with Vaqta (lot # 646789/0753N) 1ml, injection. Concomitant therapy included typhoid vaccine (unspecified) administered on 01-MAY-2006. The consumer reported that on approximately 03-MAY-2006, "2 or 3 days after the shot". she developed diarrhea, liver enzyme elevation, and a fever of 102.7. Blood work and stool samples were being performed. At the time of reporting, the patient was recovering. Additional information was received from the physician. He reported that the patient received typhoid vaccine on 01-MAY-2006. He was unsure at this time if the patient even received hepatitis A virus vaccine inactivated on 01-MAY-2006. At the time of reporting, the patient had elevated total serum alkaline phosphatase and elevated transaminase of 140. The patient had low grade hepatitis which is most likely unrelated to vaccine. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Pyrexia, Transaminases increased
Clinical narrative: Information has been received from a physician and the consumer a 48 year old female who on 01-MAY-2006 was vaccinated with Vaqta (lot # 646789/0753N) 1ml, injection. Concomitant therapy included typhoid vaccine (unspecified) administered on 01-MAY-2006. The consumer reported that on approximately 03-MAY-2006, "2 or 3 days after the shot". she developed diarrhea, liver enzyme elevation, and a fever of 102.7. Blood work and stool samples were being performed. At the time of reporting, the patient was recovering. Additional information was received from the physician. He reported that the patient received typhoid vaccine on 01-MAY-2006. He was unsure at this time if the patient even received hepatitis A virus vaccine inactivated on 01-MAY-2006. At the time of reporting, the patient had elevated total serum alkaline phosphatase and elevated transaminase of 140. The patient had low grade hepatitis which is most likely unrelated to vaccine. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Vomiting
Clinical narrative: Information has been received from a certified medical assistant concerning a 3 year old male who on 22-MAY-2006 was vaccinated with second dose of Vaqta (lot number 653616/0201F) 0.5 ml intramuscular into left deltoid. The first dose was given on 10-APR-2005. The patient has no illnesses at the time of vaccination. On  approximately 22-MAY-2006, the patient vomited within 1/2 hour of receiving Vaqta. The outcome was not reported. Follow-up information was received from the certified medical assistant who reported that the child was hospitalized and has since recovered. Additional information was received from the certified medical assistant. It was reported that on 22-MAY-2006, at 1130 hours, the patient started vomiting with 30 to 40 minutes after receiving the vaccination. The patient was taken to the emergency room (previously reported as hospitalized), was observed and was doing fine. On 22-MAY-2006, the patient recovered. No additional information is expected.
Age: 10.0
Sex: M
Vaccine: HEPA
Symptoms: Nausea, Rash erythematous
Clinical narrative: Information has been received from a certified medical assistant concerning a 10 year old male who on 05-JUN-2006 was vaccinated with his first dose of Vaqta (Lot # 652087/0937R) intramuscularly. There was no concomitant medication. On 05-JUN-2006, the patient became "nauseous and breaking out in a bright red rash that lasted about 30 or 40 seconds after being vaccinated with first dose of Vaqta". The patient had no relevant diagnostic tests/laboratory data. Subsequently, the patient recovered from nauseous and breaking out in a bright red rash. Additional information has been requested.
Sex: M
Vaccine: HEPA
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a male who was vaccinated with a dose of Vaqta (previously reported as MMRV (Oka/Merck upgrade process)). Subsequently the patient experienced severe leg pain. The patient's outcome was recovered. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Rash erythematous, Rash maculo-papular, Rash pruritic
Clinical narrative: Information has been received from a physician concerning a 48 month old female (medical history and drug reactions/allergies reported as none) who on 08-JUN-2006 was vaccinated with Vaqta (lot #653619/0144F). Concomitant medications was reported as none. On 11-JUN-2006, the patient developed red, itchy, raised, maculopapular rash that was non-crusting. The rash was widely distributed over her body and the total number of lesions was about 50. The patient was treated with over the count diphenhydramine hydrochloride (BENADRYL). The patient's red itchy raised maculopapular non-crusting rash persisted. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: HEPA
Symptoms: Rash papular
Clinical narrative: Information has been received from a physician concerning a 48 month old female child (weigh 25 kg) (medical history and drug reactions/allergies reported as none) who on the morning of 14-JUN-2006 was vaccinated with Vaqta (653616/0201F). Concomitant medication was reported as none. On 14-JUN-2006 in the PM, the patient developed a papular rash on dorsum of both hands and wrists left greater then right (previously reported as red papular rash on both wrists) several hours after the vaccination with Vaqta. The patient recovered from the papular rash on dorsum on both hands and wrist left greater than right (previously reported as the patient's red papular rash on both wrists persisted to the present). Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: HEPA
Symptoms: Anorexia, Asthenia, Dizziness, Dysphonia, Dyspnoea
Clinical narrative: Information has been received from a optometrist concerning herself, a 35 year old female with a sulfa allergy, who on 23-APR-2003 was vaccinated intramuscularly with a one time 1.0 mL dose of Vaqta (Lot # unknown). There was no concomitant medication. The doctor reported that she experienced a reaction to hepatitis A virus vaccine. The immediate reactions that occurred on 23-APR-2003 for about the first 24 hours were: felt hot, headache, loss of appetite, and tired. Fever occurred after 24 hours on 24-APR-2003 and lasted for approximately 72 hours. The doctor also experienced difficulty breathing, dizzy, nausea, hoarseness, paleness, weakness, fast heart beat, change in emotions, and feeling shaky off and on. The doctor also mentioned there was a rash on the torso and chest. Subsequently, 7 to 10 days, the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. No further information is available.
Age: 35.0
Sex: F
Vaccine: HEPA
Symptoms: Emotional disorder, Fatigue, Feeling hot, Headache, Nausea
Clinical narrative: Information has been received from a optometrist concerning herself, a 35 year old female with a sulfa allergy, who on 23-APR-2003 was vaccinated intramuscularly with a one time 1.0 mL dose of Vaqta (Lot # unknown). There was no concomitant medication. The doctor reported that she experienced a reaction to hepatitis A virus vaccine. The immediate reactions that occurred on 23-APR-2003 for about the first 24 hours were: felt hot, headache, loss of appetite, and tired. Fever occurred after 24 hours on 24-APR-2003 and lasted for approximately 72 hours. The doctor also experienced difficulty breathing, dizzy, nausea, hoarseness, paleness, weakness, fast heart beat, change in emotions, and feeling shaky off and on. The doctor also mentioned there was a rash on the torso and chest. Subsequently, 7 to 10 days, the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. No further information is available.
Age: 35.0
Sex: F
Vaccine: HEPA
Symptoms: Pallor, Rash, Tachycardia, Tremor
Clinical narrative: Information has been received from a optometrist concerning herself, a 35 year old female with a sulfa allergy, who on 23-APR-2003 was vaccinated intramuscularly with a one time 1.0 mL dose of Vaqta (Lot # unknown). There was no concomitant medication. The doctor reported that she experienced a reaction to hepatitis A virus vaccine. The immediate reactions that occurred on 23-APR-2003 for about the first 24 hours were: felt hot, headache, loss of appetite, and tired. Fever occurred after 24 hours on 24-APR-2003 and lasted for approximately 72 hours. The doctor also experienced difficulty breathing, dizzy, nausea, hoarseness, paleness, weakness, fast heart beat, change in emotions, and feeling shaky off and on. The doctor also mentioned there was a rash on the torso and chest. Subsequently, 7 to 10 days, the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. No further information is available.
Age: 8.0
Sex: F
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning an 8 year old female who was vaccinated IM with a dose of Vaqta. Subsequently, the patient developed rash. Unspecified medical attention was sought. There was no product quality complaint. Follow-up information received from a registered nurse indicating that "no one in the office recalls anything like this". No additional information expected.
Sex: U
Vaccine: HEPA
Symptoms: Dizziness, Injection site haemorrhage, Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning a patient, (demographics unknown), with a history of hepatitis C and treatment with interferon who, "within the last 12 months", was vaccinated with Vaqta (manufacturer unknown). Within the past 12 months, the patient experienced arm hurting more with the second shot than with the first shot. There was bleeding from injection site and dizziness. Unspecified medical attention was sought. Subsequently, the patient recovered from the arm hurting, bleeding from injection site and dizziness. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HEPA
Symptoms: Rash erythematous
Clinical narrative: Information has been received from a pharmacist concerning a 12 year old male who was vaccinated about 1 month ago with Vaqta. In approximately July 2006, a week after the vaccination, the patient experienced a red rash on his chest that "seemed to form in lines." "The rash seems to have come and gone several times over the last three weeks". Unspecified medical attention was sought. No other symptoms were noted. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Erythema, Incorrect route of drug administration
Clinical narrative: Information has been received from a nurse concerning three children, ages 7, 11 and 13 years old (age of patient not specified) of who on 23-JUN-2006 were vaccinated with Vaqta. Regarding this patient, the patient was administered the vaccine subcutaneously. The second dose of the region was administered on 28-Jul-2006, approximately 1 month after first dose. The patient also experienced redness of upper extremity. Unspecified medical attention was sought. No product quality complaint. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Erythema, Incorrect route of drug administration
Clinical narrative: Information has been received from a nurse concerning three children, ages 7, 11 and 13 years old (age of patient not specified) of who on 23-JUN-2006 were vaccinated with Vaqta. Regarding this patient, the patient was administered the vaccine subcutaneously. The second dose of the regimen was administered on 28-Jul-2006, approximately 1 month after first dose. The patient also experienced redness of upper extremity. Unspecified medical attention was sought. No product quality complaint. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Fatigue, Hepatic function abnormal, Hepatitis A antibody positive
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old white male student weight 150 pounds with fatigue at the time of the vaccination and unspecified medical history, and drug reactions/allergies reported as none. On 21-JUL-2006, the patient was vaccinated with the second dose of Vaqta (lot # 653144/0602F) IM into left arm. The patient also received TDAP (lot # AC52B005BA) IM right arm on 21-JUL-2006. Concomitant therapy included bupropion HCl (WELLBUTRIN) and trazodone HCl. The nurse reported that on 23-JUL-2006, the patient received Vaqta and then developed elevated liver function tests, fatigue and itching. Medical attention was sought. On 23-JUL-2006, laboratory evaluation revealed elevated serum alanine aminotransferase (ALT) 148 and elevated serum aspartate aminotransferase (AST) 98. On 31-JUL-2006, his ALT was 169 and AST 79. On 03-AUG-2006, his ALT decreased to 101 and his AST decreased to 47. At the time of reporting the patient was recovering. Follow-up information was received from the registered nurse. The patient complained of fatigue on 07-JUL-2006. At the time of vaccination on 21-JUL-2006, he had fatigue. On 23-JUL-2006, laboratory evaluation revealed positive Hepatitis A IgM. On an unspecified date, his total anti-HAV was positive. No additional information is expected.
Age: 15.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Off label use, Pruritus, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old white male student weight 150 pounds with fatigue at the time of the vaccination and unspecified medical history, and drug reactions/allergies reported as none. On 21-JUL-2006, the patient was vaccinated with the second dose of Vaqta (lot # 653144/0602F) IM into left arm. The patient also received TDAP (lot # AC52B005BA) IM right arm on 21-JUL-2006. Concomitant therapy included bupropion HCl (WELLBUTRIN) and trazodone HCl. The nurse reported that on 23-JUL-2006, the patient received Vaqta and then developed elevated liver function tests, fatigue and itching. Medical attention was sought. On 23-JUL-2006, laboratory evaluation revealed elevated serum alanine aminotransferase (ALT) 148 and elevated serum aspartate aminotransferase (AST) 98. On 31-JUL-2006, his ALT was 169 and AST 79. On 03-AUG-2006, his ALT decreased to 101 and his AST decreased to 47. At the time of reporting the patient was recovering. Follow-up information was received from the registered nurse. The patient complained of fatigue on 07-JUL-2006. At the time of vaccination on 21-JUL-2006, he had fatigue. On 23-JUL-2006, laboratory evaluation revealed positive Hepatitis A IgM. On an unspecified date, his total anti-HAV was positive. No additional information is expected.
Age: 2.5
Sex: M
Vaccine: HEPA
Symptoms: Rash generalised, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 30 month old male with no pertinent medical history and no known allergies who on 12-AUG-2006 was vaccinated with Vaqta (lot #654337/0510f) 0.5 mL intramuscularly in the left leg. There was no concomitant medication. This was the patient's first dose of Vaqta. On 15-AUG-2006 the patient presented to the doctor's office with red splotches over his body. The child did not seem to be ill or in distress and had no fever. Oral diphenhydramine hydrochloride (BENADRYL) was administered. The patient's red splotches over his body persisted at the time of reporting. There was no product quality complaint involved. The nurse reported that intervention to prevent serious criteria (Other Important Medical Event) was needed for the event. Additional information has been received from the physician indicating that the patient woke on 15-AUG-2006 with the splotchy red rash/urticarial rash and was not sick. The physician was unsure whether the rash was related to the Vaqta or "either food, drug, vital exposure." The patient recovered. It was now reported that the event did not require medical or surgical intervention to prevent serious criteria. Additional information is not expected.