chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.5
Sex: F
Vaccine: HIBV, PNC, HIBV, PNC
Symptoms: Bronchiolitis, Dyspnoea, Pallor, Pyrexia, Swelling
Clinical narrative: A mother reported, via a company representative, that her 4 1/2 year old daughter received an initial dose of Prevnar in 12/00. In 12/00, she developed wheezing and coughing. In 1/01, the child developed a "barking" cough that did not resolve for months. The child has also been on antibiotics every month since receiving Prevnar for ear infections. The healthcare provider told the mother that the child's lungs were clear. In 4/01, the child developed bilateral ear infections, cough and was dx'd with pneumonia. The child developed a fever of 104F, of 6 days duration. After 2 days of fever, she was treated with azithromycin (Zithromax) with no resolution of fever. The child developed "violent" vomiting for 3 days and then developed "severe" diarrhea. The fever was treated with acetaminophen (Tylenol) or ibuprofen (Advil) and it resolved. No additional information was available as of the date of this report. Follow up info recieved on 7/30/01 , Prevnar and Hib-titer vaccines received on 4/25/01. Concurrent medication included Augmentin. Lab data includes chest x-ray that revealed no active lung disease. The child recovered. Follow up info received 7/27/01, stated that child had several ER visits following Prevnar immunization. Additional info received 9/7/01, four days post 2nd Prevnar immunization, child started vomiting. She vomited 5 times before being seen in the ER. In July 2001, the child was given a diagnosis of asthma.
Age: 1.5
Sex: F
Vaccine: HIBV, PNC, HIBV, PNC
Symptoms: Vaccine positive rechallenge, Wheezing
Clinical narrative: A mother reported, via a company representative, that her 4 1/2 year old daughter received an initial dose of Prevnar in 12/00. In 12/00, she developed wheezing and coughing. In 1/01, the child developed a "barking" cough that did not resolve for months. The child has also been on antibiotics every month since receiving Prevnar for ear infections. The healthcare provider told the mother that the child's lungs were clear. In 4/01, the child developed bilateral ear infections, cough and was dx'd with pneumonia. The child developed a fever of 104F, of 6 days duration. After 2 days of fever, she was treated with azithromycin (Zithromax) with no resolution of fever. The child developed "violent" vomiting for 3 days and then developed "severe" diarrhea. The fever was treated with acetaminophen (Tylenol) or ibuprofen (Advil) and it resolved. No additional information was available as of the date of this report. Follow up info recieved on 7/30/01 , Prevnar and Hib-titer vaccines received on 4/25/01. Concurrent medication included Augmentin. Lab data includes chest x-ray that revealed no active lung disease. The child recovered. Follow up info received 7/27/01, stated that child had several ER visits following Prevnar immunization. Additional info received 9/7/01, four days post 2nd Prevnar immunization, child started vomiting. She vomited 5 times before being seen in the ER. In July 2001, the child was given a diagnosis of asthma.
Age: 1.5
Sex: F
Vaccine: HIBV, PNC, HIBV, PNC
Symptoms: Asthma, Cough, Diarrhoea, Ear disorder, Infection
Clinical narrative: A mother reported, via a company representative, that her 4 1/2 year old daughter received an initial dose of Prevnar in 12/00. In 12/00, she developed wheezing and coughing. In 1/01, the child developed a "barking" cough that did not resolve for months. The child has also been on antibiotics every month since receiving Prevnar for ear infections. The healthcare provider told the mother that the child's lungs were clear. In 4/01, the child developed bilateral ear infections, cough and was dx'd with pneumonia. The child developed a fever of 104F, of 6 days duration. After 2 days of fever, she was treated with azithromycin (Zithromax) with no resolution of fever. The child developed "violent" vomiting for 3 days and then developed "severe" diarrhea. The fever was treated with acetaminophen (Tylenol) or ibuprofen (Advil) and it resolved. No additional information was available as of the date of this report. Follow up info recieved on 7/30/01 , Prevnar and Hib-titer vaccines received on 4/25/01. Concurrent medication included Augmentin. Lab data includes chest x-ray that revealed no active lung disease. The child recovered. Follow up info received 7/27/01, stated that child had several ER visits following Prevnar immunization. Additional info received 9/7/01, four days post 2nd Prevnar immunization, child started vomiting. She vomited 5 times before being seen in the ER. In July 2001, the child was given a diagnosis of asthma.
Age: 1.5
Sex: F
Vaccine: HIBV, PNC, HIBV, PNC
Symptoms: Pneumonia, Pyrexia, Vomiting, Wheezing
Clinical narrative: A mother reported, via a company representative, that her 4 1/2 year old daughter received an initial dose of Prevnar in 12/00. In 12/00, she developed wheezing and coughing. In 1/01, the child developed a "barking" cough that did not resolve for months. The child has also been on antibiotics every month since receiving Prevnar for ear infections. The healthcare provider told the mother that the child's lungs were clear. In 4/01, the child developed bilateral ear infections, cough and was dx'd with pneumonia. The child developed a fever of 104F, of 6 days duration. After 2 days of fever, she was treated with azithromycin (Zithromax) with no resolution of fever. The child developed "violent" vomiting for 3 days and then developed "severe" diarrhea. The fever was treated with acetaminophen (Tylenol) or ibuprofen (Advil) and it resolved. No additional information was available as of the date of this report. Follow up info recieved on 7/30/01 , Prevnar and Hib-titer vaccines received on 4/25/01. Concurrent medication included Augmentin. Lab data includes chest x-ray that revealed no active lung disease. The child recovered. Follow up info received 7/27/01, stated that child had several ER visits following Prevnar immunization. Additional info received 9/7/01, four days post 2nd Prevnar immunization, child started vomiting. She vomited 5 times before being seen in the ER. In July 2001, the child was given a diagnosis of asthma.
Age: 2.0
Sex: M
Vaccine: PNC, PNC
Symptoms: Urticaria
Clinical narrative: A company representative reported that a 2 year old male received his 2nd dose of Prevnar on 7/5/01. Within minutes of leaving the office, the child developed hives and returned to the physician's office. He was treated with Benadryl and steroids and his symptoms abated. No further information was available at the date of the report. Additional information received from the physician's office on 7/30/01, provided the name of the pt, as well as, the route and site of vaccine administration.
Age: 0.5
Sex: F
Vaccine: DTAP, PNC, DTAP, PNC
Symptoms: Convulsion, Muscle twitching, Pyrexia
Clinical narrative: 10 hours post vax, the infant experienced a seizure lasting 35 minutes. The reporter stated that she was resuscitated and taken to the ER but not admitted. The reporter stated that on 7/8/01 the infant again experienced a seizure and was taken to the ER but not admitted. These events were considered to be medically important. No further information was available at the date of the report.
Age: 0.5
Sex: F
Vaccine: DTAP, PNC, DTAP, PNC
Symptoms: Convulsion
Clinical narrative: 10 hours post vax, the infant experienced a seizure lasting 35 minutes. The reporter stated that she was resuscitated and taken to the ER but not admitted. The reporter stated that on 7/8/01 the infant again experienced a seizure and was taken to the ER but not admitted. These events were considered to be medically important. No further information was available at the date of the report.
Age: 3.0
Sex: M
Vaccine: PNC, PNC, PNC
Symptoms: Angioneurotic oedema, Injection site erythema, Injection site swelling
Clinical narrative: A mother reported that subsequent to receiving vax, the pt developed urticaria on his face, neck and trunk. The mother notified his health care provider and the pt was treated with Benadryl. The hives resolved the following day, however they returned about two weeks later. No additional information was available as of the date of this report.
Age: 3.0
Sex: M
Vaccine: PNC, PNC, PNC
Symptoms: Eye swelling, Oedema peripheral, Purpura, Swelling face, Urticaria
Clinical narrative: A mother reported that subsequent to receiving vax, the pt developed urticaria on his face, neck and trunk. The mother notified his health care provider and the pt was treated with Benadryl. The hives resolved the following day, however they returned about two weeks later. No additional information was available as of the date of this report.
Age: 3.0
Sex: M
Vaccine: PNC, PNC, PNC
Symptoms: Urticaria
Clinical narrative: A mother reported that subsequent to receiving vax, the pt developed urticaria on his face, neck and trunk. The mother notified his health care provider and the pt was treated with Benadryl. The hives resolved the following day, however they returned about two weeks later. No additional information was available as of the date of this report.
Age: 1.25
Sex: F
Vaccine: DTAP, HBHEPB, PNC, DTAP, HBHEPB, PNC
Symptoms: Apnoea, Convulsion, Drooling, Ear disorder, Eye movement disorder
Clinical narrative: That same day, the child developed a fever of 102 and experienced a febrile seizure. she was seen in an ER and recovered. Febrile seizure is considered medically important. Follow-up info received on 10/19/2001 from the physician indicated that the child received Prevnar, Comvax, and Tripedia on 01/24/2001. That same day, the pt experienced a seizure described as "eyes rolled back, turned white, foaming at mouth, not breathing, rhythmic shaking." Transported to ER and the following day, she was seen by the physician who diagnosed the child with otitis media.
Age: 1.25
Sex: F
Vaccine: DTAP, HBHEPB, PNC, DTAP, HBHEPB, PNC
Symptoms: Infection, Pallor, Tremor
Clinical narrative: That same day, the child developed a fever of 102 and experienced a febrile seizure. she was seen in an ER and recovered. Febrile seizure is considered medically important. Follow-up info received on 10/19/2001 from the physician indicated that the child received Prevnar, Comvax, and Tripedia on 01/24/2001. That same day, the pt experienced a seizure described as "eyes rolled back, turned white, foaming at mouth, not breathing, rhythmic shaking." Transported to ER and the following day, she was seen by the physician who diagnosed the child with otitis media.
Age: 1.25
Sex: F
Vaccine: DTAP, HBHEPB, PNC, DTAP, HBHEPB, PNC
Symptoms: Apnoea, Eye movement disorder, Febrile convulsion, Otitis media, Pallor
Clinical narrative: That same day, the child developed a fever of 102 and experienced a febrile seizure. she was seen in an ER and recovered. Febrile seizure is considered medically important. Follow-up info received on 10/19/2001 from the physician indicated that the child received Prevnar, Comvax, and Tripedia on 01/24/2001. That same day, the pt experienced a seizure described as "eyes rolled back, turned white, foaming at mouth, not breathing, rhythmic shaking." Transported to ER and the following day, she was seen by the physician who diagnosed the child with otitis media.
Age: 1.25
Sex: F
Vaccine: DTAP, HBHEPB, PNC, DTAP, HBHEPB, PNC
Symptoms: Pyrexia, Tremor
Clinical narrative: That same day, the child developed a fever of 102 and experienced a febrile seizure. she was seen in an ER and recovered. Febrile seizure is considered medically important. Follow-up info received on 10/19/2001 from the physician indicated that the child received Prevnar, Comvax, and Tripedia on 01/24/2001. That same day, the pt experienced a seizure described as "eyes rolled back, turned white, foaming at mouth, not breathing, rhythmic shaking." Transported to ER and the following day, she was seen by the physician who diagnosed the child with otitis media.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL, HIBV, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: A nurse reported that a 12 month old female who received Prevnar, Hib-Titer, MMR and Varivax vaccines on 7/13/01 and within 24 hours, post vax, she developed a fever of 105F and a generalized rash. She was taken to the ER and "blood work" was performed. The physician indicated that the child was experiencing a "vaccine reaction" and she was discharged that same day. On 7/15/01, she was taken back to the ER after spiking a fever of 105F. The physician indicated that the child was again experiencing a "vaccine reaction" and she was sent home. On 7/18/01, she was taken to the clinic with a fever of 101F. She was treated with acetaminophen and ibuprofen.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL, HIBV, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: A nurse reported that a 12 month old female who received Prevnar, Hib-Titer, MMR and Varivax vaccines on 7/13/01 and within 24 hours, post vax, she developed a fever of 105F and a generalized rash. She was taken to the ER and "blood work" was performed. The physician indicated that the child was experiencing a "vaccine reaction" and she was discharged that same day. On 7/15/01, she was taken back to the ER after spiking a fever of 105F. The physician indicated that the child was again experiencing a "vaccine reaction" and she was sent home. On 7/18/01, she was taken to the clinic with a fever of 101F. She was treated with acetaminophen and ibuprofen.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Agitation, Diarrhoea, Injection site erythema, Injection site swelling, Lymphopenia
Clinical narrative: Per mom, post vax, pt took 1 oz of formula and fell asleep. She was awakened at approx. 16:00 and refused to eat. She started crying non-stop from 17:30 to 19:30 and fell asleep at 19:45. Sometime this evening, her temperature climbed to 103.2F and she was taken to the hospital. In the ER, she was vomiting and was given suppositories. On 8/30/01, she was taken to the doctor where blood and urine samples were taken. She was given a shot of Rocephin, at this time. Both legs were red and swollen at the injection sites. On 8/31/01, she was taken back to the doctor because of continued diarrhea and vomiting. Another shot of Rocephin was given. On 9/1/01, mom states that she took some Pedialyte but pushed nipple back on formula. She had less diarrhea and vomiting today. On 9/2/01, the baby took 12 oz of formula today. No Pedialyte offered. Baby had less diarrhea and vomiting than yesterday, per mom. On 9/3/01, mom felt she was "turning around" for better by today. The way the baby acted, ate and slept was better. On 9/5/01, pt was seen again at doctor's office today for a check-up and baby is back to "normal" per doctor and mom.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Oral intake reduced, Pyrexia, Vomiting, White blood cell count increased
Clinical narrative: Per mom, post vax, pt took 1 oz of formula and fell asleep. She was awakened at approx. 16:00 and refused to eat. She started crying non-stop from 17:30 to 19:30 and fell asleep at 19:45. Sometime this evening, her temperature climbed to 103.2F and she was taken to the hospital. In the ER, she was vomiting and was given suppositories. On 8/30/01, she was taken to the doctor where blood and urine samples were taken. She was given a shot of Rocephin, at this time. Both legs were red and swollen at the injection sites. On 8/31/01, she was taken back to the doctor because of continued diarrhea and vomiting. Another shot of Rocephin was given. On 9/1/01, mom states that she took some Pedialyte but pushed nipple back on formula. She had less diarrhea and vomiting today. On 9/2/01, the baby took 12 oz of formula today. No Pedialyte offered. Baby had less diarrhea and vomiting than yesterday, per mom. On 9/3/01, mom felt she was "turning around" for better by today. The way the baby acted, ate and slept was better. On 9/5/01, pt was seen again at doctor's office today for a check-up and baby is back to "normal" per doctor and mom.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Crying, Diarrhoea, Injection site erythema, Injection site swelling, Oral intake reduced
Clinical narrative: Per mom, post vax, pt took 1 oz of formula and fell asleep. She was awakened at approx. 16:00 and refused to eat. She started crying non-stop from 17:30 to 19:30 and fell asleep at 19:45. Sometime this evening, her temperature climbed to 103.2F and she was taken to the hospital. In the ER, she was vomiting and was given suppositories. On 8/30/01, she was taken to the doctor where blood and urine samples were taken. She was given a shot of Rocephin, at this time. Both legs were red and swollen at the injection sites. On 8/31/01, she was taken back to the doctor because of continued diarrhea and vomiting. Another shot of Rocephin was given. On 9/1/01, mom states that she took some Pedialyte but pushed nipple back on formula. She had less diarrhea and vomiting today. On 9/2/01, the baby took 12 oz of formula today. No Pedialyte offered. Baby had less diarrhea and vomiting than yesterday, per mom. On 9/3/01, mom felt she was "turning around" for better by today. The way the baby acted, ate and slept was better. On 9/5/01, pt was seen again at doctor's office today for a check-up and baby is back to "normal" per doctor and mom.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia, Vomiting, White blood cell count increased
Clinical narrative: Per mom, post vax, pt took 1 oz of formula and fell asleep. She was awakened at approx. 16:00 and refused to eat. She started crying non-stop from 17:30 to 19:30 and fell asleep at 19:45. Sometime this evening, her temperature climbed to 103.2F and she was taken to the hospital. In the ER, she was vomiting and was given suppositories. On 8/30/01, she was taken to the doctor where blood and urine samples were taken. She was given a shot of Rocephin, at this time. Both legs were red and swollen at the injection sites. On 8/31/01, she was taken back to the doctor because of continued diarrhea and vomiting. Another shot of Rocephin was given. On 9/1/01, mom states that she took some Pedialyte but pushed nipple back on formula. She had less diarrhea and vomiting today. On 9/2/01, the baby took 12 oz of formula today. No Pedialyte offered. Baby had less diarrhea and vomiting than yesterday, per mom. On 9/3/01, mom felt she was "turning around" for better by today. The way the baby acted, ate and slept was better. On 9/5/01, pt was seen again at doctor's office today for a check-up and baby is back to "normal" per doctor and mom.
Age: 1.25
Sex: F
Vaccine: DTAP, HBHEPB, IPV, DTAP, HBHEPB, IPV
Symptoms: Injection site erythema, Pain
Clinical narrative: Per mom; symptoms started on 8/30/01 at 08:00 with redness size 3" in diameter in left leg with complaint of pain. Tylenol was given on Thursday and Friday 2 X, both days. Mom says "spot" is pin point in size since 9/1/01 and no "knot".
Age: 1.25
Sex: F
Vaccine: DTAP, HBHEPB, IPV, DTAP, HBHEPB, IPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Per mom; symptoms started on 8/30/01 at 08:00 with redness size 3" in diameter in left leg with complaint of pain. Tylenol was given on Thursday and Friday 2 X, both days. Mom says "spot" is pin point in size since 9/1/01 and no "knot".
Age: 1.4
Sex: M
Vaccine: DTAP, HBHEPB, IPV, DTAP, HBHEPB, IPV
Symptoms: Erythema, Oedema, Pain
Clinical narrative: Per mother's friend; symptoms started on 8/24/01 evening. Pt complained of redness, swelling and soreness in the left leg. Tylenol was given for treatment of symptoms. Friend brought baby for shots with permission by mom.
Age: 1.4
Sex: M
Vaccine: DTAP, HBHEPB, IPV, DTAP, HBHEPB, IPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Per mother's friend; symptoms started on 8/24/01 evening. Pt complained of redness, swelling and soreness in the left leg. Tylenol was given for treatment of symptoms. Friend brought baby for shots with permission by mom.
Age: 1.25
Sex: F
Vaccine: HIBV, IPV, TTOX, DTAP, HIBV, IPV
Symptoms: Crying, Erythema, Oral intake reduced, Screaming
Clinical narrative: Symptoms started approx. 4 hours, post vax. Pt didn't want to eat supper. She screamed when she stood up. Cried "a lot" between 17:30 and bedtime at 20:30. Mom says she had redness the size of a nickel but no knot.
Age: 1.25
Sex: F
Vaccine: HIBV, IPV, TTOX, DTAP, HIBV, IPV
Symptoms: Crying, Hypokinesia, Injection site erythema, Oral intake reduced
Clinical narrative: Symptoms started approx. 4 hours, post vax. Pt didn't want to eat supper. She screamed when she stood up. Cried "a lot" between 17:30 and bedtime at 20:30. Mom says she had redness the size of a nickel but no knot.
Age: 1.75
Sex: F
Vaccine: DTAP, HIBV, IPV, DTAP, HIBV, IPV
Symptoms: Abasia, Injection site mass, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: On 8/29/01, upon awakening at 07:00, the child would not stand on left leg and cried with pain upon trying to stand. Left leg is swollen, 2" in diameter, warm to touch, with a "knot" but no redness noted. Mom used Advil for low-grade temperature and pain. She used a cool wash rag to area and mom massaged leg. On 8/30/01, child is back walking without complaint of pain. Swelling is gone but "knot" remains palpable per mom in left leg.
Age: 1.75
Sex: F
Vaccine: DTAP, HIBV, IPV, DTAP, HIBV, IPV
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: On 8/29/01, upon awakening at 07:00, the child would not stand on left leg and cried with pain upon trying to stand. Left leg is swollen, 2" in diameter, warm to touch, with a "knot" but no redness noted. Mom used Advil for low-grade temperature and pain. She used a cool wash rag to area and mom massaged leg. On 8/30/01, child is back walking without complaint of pain. Swelling is gone but "knot" remains palpable per mom in left leg.
Age: 1.75
Sex: F
Vaccine: DTAP, HIBV, IPV, DTAP, HIBV, IPV
Symptoms: Crying, Hypokinesia, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: On 8/29/01, upon awakening at 07:00, the child would not stand on left leg and cried with pain upon trying to stand. Left leg is swollen, 2" in diameter, warm to touch, with a "knot" but no redness noted. Mom used Advil for low-grade temperature and pain. She used a cool wash rag to area and mom massaged leg. On 8/30/01, child is back walking without complaint of pain. Swelling is gone but "knot" remains palpable per mom in left leg.
Age: 8.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Headache, Malaise, Rash vesicular
Clinical narrative: Rash onset, 3 days ago, with malaise and headache. Seen on 9/23/01 with 5 vesicles and about 20 spots.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Abortion
Clinical narrative: A 30 year old female was vaccinated with varicella virus vaccine lives on 10/31/00. On 12/04/00, the patient received the 2nd dose of varicella vaccine live. The patient's last menstrual period was 11/10/00. The patient has been to the obstetrician gynecologist and has heard the fetal heart beat. The patient reported that her doctor had advised her to terminate the pregnancy. In follow-up, the physician reported that the patient had "terminated the pregnancy shortly after the diagnosis was made". The patient did not have a rash.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Albumin globulin ratio abnormal, Blood thyroid stimulating hormone increased, Electrocardiogram abnormal, Hypertension, Hypothyroidism
Clinical narrative: It was initially reported on 08/14/01, between 14:00 and 17:00, the vaccinee (white female) received her 1st dose of Engerix-B. Approximately seven or eight hours later, at 24:00, she awoke with a heart rate of 152 beats per minute. Emergency medical services were called, and the vaccinee was taken to the local ER. Upon arrival at the ER, her heart rate was 88 beats per minute, and her blood pressure was 168 / 90 mmHg. The vaccinee took two capsules (strength unk) of diphenhydramine hydrochloride (Benadryl) and went to sleep. The hypertension and tachycardia resolved on 08/14/01. The vaccinee was seen by her personal physician on 08/16/01. The most recent info was received on 09/25/01. The vaccine provider stated that the hypertension and tachycardia were severe in intensity and life-threatening. The vaccine provider considered the events to be possibly related to Engerix-B administration, the vaccinee's personal physician recommended that the vaccinee receive the 2nd dose on Engerix-B. F/U states that the Synthroid dosage was increased to 0.112mg daily. Information received on 10/2/01 indicated that blood chemistry, including assessment of thyroid function, was performed at the ER at 16:24 on 9/24/01. Thyroid function tests revealed a thyroxine concentration of 9.8mcg/dL (reference range, 6.0-12.2), triiodothyronine uptake of 34.3% (referenace range, 32.0-48.4) and a tyroid stimulating hormone (TSH) concentration of 10.85uIU/mL (reference range, 0.34-5.60). An ECG was performed at the ER at 16:36 on 9/14/01. The ECG revealed normal sinus rhythm at a rate of 75 beats/minute. A non-specific ST and T wave abnormality was noted. Other lab findings included an elevated globulin concentration, reduced albumin/globulin (A/G) ratio, reduced mean platelet volume and increased neutrophil count (pleas see lab data section for details).
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Tachycardia, Volume blood decreased, White blood cell count increased
Clinical narrative: It was initially reported on 08/14/01, between 14:00 and 17:00, the vaccinee (white female) received her 1st dose of Engerix-B. Approximately seven or eight hours later, at 24:00, she awoke with a heart rate of 152 beats per minute. Emergency medical services were called, and the vaccinee was taken to the local ER. Upon arrival at the ER, her heart rate was 88 beats per minute, and her blood pressure was 168 / 90 mmHg. The vaccinee took two capsules (strength unk) of diphenhydramine hydrochloride (Benadryl) and went to sleep. The hypertension and tachycardia resolved on 08/14/01. The vaccinee was seen by her personal physician on 08/16/01. The most recent info was received on 09/25/01. The vaccine provider stated that the hypertension and tachycardia were severe in intensity and life-threatening. The vaccine provider considered the events to be possibly related to Engerix-B administration, the vaccinee's personal physician recommended that the vaccinee receive the 2nd dose on Engerix-B. F/U states that the Synthroid dosage was increased to 0.112mg daily. Information received on 10/2/01 indicated that blood chemistry, including assessment of thyroid function, was performed at the ER at 16:24 on 9/24/01. Thyroid function tests revealed a thyroxine concentration of 9.8mcg/dL (reference range, 6.0-12.2), triiodothyronine uptake of 34.3% (referenace range, 32.0-48.4) and a tyroid stimulating hormone (TSH) concentration of 10.85uIU/mL (reference range, 0.34-5.60). An ECG was performed at the ER at 16:36 on 9/14/01. The ECG revealed normal sinus rhythm at a rate of 75 beats/minute. A non-specific ST and T wave abnormality was noted. Other lab findings included an elevated globulin concentration, reduced albumin/globulin (A/G) ratio, reduced mean platelet volume and increased neutrophil count (pleas see lab data section for details).
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Aphasia, Diarrhoea, Eye disorder, Hearing impaired
Clinical narrative: The pt developed permanent chronic diarrhea, arersion to eye contact, change in hearing and stopped speaking. Diarrhea and loss of speech were immediate others were gradual onset approximately 1 month.
Age: 50.0
Sex: M
Vaccine: LYME
Symptoms: Antinuclear antibody positive, Arthralgia, Dizziness, Feeling hot, Red blood cell sedimentation rate increased
Clinical narrative: 1 month following 2nd injection, the pt became hot, dizzy with impaired vision. This reoccurred 1 week later and was worse. A CAT scan was performed. The pt remained sun sensitive all summer and was never sensitive before. The pt recovered during the winter months. Problems reoccurred in late Feb in the left great toe. The pt saw a podiatrist, had biopsy. Pain in toe (foot and thigh) lasted 4 months. Problems increased in 7/01 with multiple joint pain and heat sensitivity. Saw MD several times. The pt was treated with 400 mg of Celebrex daily. The pt has an appointment with rheumatologist. Additional information received on 12/26/2001: Patient continues to have symptoms as previously stated. He is being seen by a family doctor and Rheumatologist. After extensive blood tests, they are 99% sure that patient has some type of Lupus, but no definate diagnosis. We feel this was caused by the vaccine. He had no medical problems prior to the injections. Follow up information received 10/18/02 stated, " Pt diagnosed with Lupus. Pt still has some of the same original symptoms and is under doctor's care. He will have to be on medication the remainder of his life."
Age: 50.0
Sex: M
Vaccine: LYME
Symptoms: Skin disorder, Systemic lupus erythematosus, Visual acuity reduced
Clinical narrative: 1 month following 2nd injection, the pt became hot, dizzy with impaired vision. This reoccurred 1 week later and was worse. A CAT scan was performed. The pt remained sun sensitive all summer and was never sensitive before. The pt recovered during the winter months. Problems reoccurred in late Feb in the left great toe. The pt saw a podiatrist, had biopsy. Pain in toe (foot and thigh) lasted 4 months. Problems increased in 7/01 with multiple joint pain and heat sensitivity. Saw MD several times. The pt was treated with 400 mg of Celebrex daily. The pt has an appointment with rheumatologist. Additional information received on 12/26/2001: Patient continues to have symptoms as previously stated. He is being seen by a family doctor and Rheumatologist. After extensive blood tests, they are 99% sure that patient has some type of Lupus, but no definate diagnosis. We feel this was caused by the vaccine. He had no medical problems prior to the injections. Follow up information received 10/18/02 stated, " Pt diagnosed with Lupus. Pt still has some of the same original symptoms and is under doctor's care. He will have to be on medication the remainder of his life."
Age: 0.4
Sex: M
Vaccine: DTAP, PNC, DTAP, PNC
Symptoms: Convulsion, Electroencephalogram abnormal
Clinical narrative: The pt experienced an onset of infantile spasms and an abnormal EEG. Follow up information received 10/18/02, stated, " Infantile spasms controlled by meds, long-term developmental outcome - too soon to tell."
Age: 0.4
Sex: M
Vaccine: DTAP, PNC, DTAP, PNC
Symptoms: Electroencephalogram abnormal, Infantile spasms
Clinical narrative: The pt experienced an onset of infantile spasms and an abnormal EEG. Follow up information received 10/18/02, stated, " Infantile spasms controlled by meds, long-term developmental outcome - too soon to tell."
Age: 1.25
Sex: F
Vaccine: DTAPH, MMR, OPV
Symptoms: Convulsion, Muscle twitching, Nervous system disorder, Otitis media, Pyrexia
Clinical narrative: The pt experienced a prolonged seizure 16 hours post vax. Temperature at time was 102.5 rectally. Right arms and legs were twitching. 2 months later the pt started having complex partial seizures and was diagnosed with medial temporal sclerosis. The pt is currently on Lamictal to control seizures.  Also diagnosed with OM, viral stomatitis, URI. Follow up information receivced 10/21/02 stated, "Brain damage, seizures, epilepsy"
Age: 1.25
Sex: F
Vaccine: DTAPH, MMR, OPV
Symptoms: Stomatitis, Upper respiratory tract infection
Clinical narrative: The pt experienced a prolonged seizure 16 hours post vax. Temperature at time was 102.5 rectally. Right arms and legs were twitching. 2 months later the pt started having complex partial seizures and was diagnosed with medial temporal sclerosis. The pt is currently on Lamictal to control seizures.  Also diagnosed with OM, viral stomatitis, URI. Follow up information receivced 10/21/02 stated, "Brain damage, seizures, epilepsy"
Age: 1.3
Sex: M
Vaccine: DTP, HIBV, MMR, OPV, VARCEL
Symptoms: Diarrhoea, Eye disorder, Fungal infection, Gait disturbance, Hypoacusis
Clinical narrative: The pt experienced chronic permanent diarrhea, chronic "yeast infection" type rashes, change in hearing, loss of eye contact, started to walk on tip toes and spin allot.
Age: 1.3
Sex: M
Vaccine: DTP, HIBV, MMR, OPV, VARCEL
Symptoms: Rash
Clinical narrative: The pt experienced chronic permanent diarrhea, chronic "yeast infection" type rashes, change in hearing, loss of eye contact, started to walk on tip toes and spin allot.
Age: 2.0
Sex: F
Vaccine: DTAP, HBHEPB, IPV, MMR, PNC
Symptoms: Erythema, Urticaria
Clinical narrative: Mom complained of "hives" appearing on 9/22/01 PM on butt and top of thigh. No fever, no other symptoms. Never had a reaction to shots before. Took child to doctor, by the time they got there, buttocks were red and tops of backs of thighs was gone. He dx'd "hives". The "hives" come and go and are still present today, 9/25/01.
Age: 4.0
Sex: M
Vaccine: PNC
Symptoms: Hallucination, Pyrexia
Clinical narrative: Pt developed a fever over 103F with hallucinations.
Age: 3.0
Sex: F
Vaccine: PNC
Symptoms: Injection site reaction
Clinical narrative: Pt developed a 5" X 4" large, local reaction less than 24 hours, post vax.
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Rales, Viral infection
Clinical narrative: The pt received his shots in 8/01, 10 days later, he woke up covered in red bumps; I took him to the ER to find out he had Rubella.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Pt received DTAP #5 and post vax, there was a red induration.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Screaming
Clinical narrative: Inconsolable crying for 5 hours. Treated with Motrin and Benadryl.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: Had documented temperature by thermometer at 105F. Responded to bath and Tylenol.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Urticaria
Clinical narrative: Pt developed generalized urticaria, about 30 hours, post vax, which lasted 48 hours.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Pt presented to our office today with a round red rash on trunk, behind ears and in genital area. Dx'd by our physician as "chickenpox". History of step-sister having same.
Age: 1.6
Sex: M
Vaccine: RUB
Symptoms: Face oedema, Hyperaemia
Clinical narrative: The pt experienced mild hyperemia of cheeks, and facial cheek swelling.
Age: 13.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Dehydration, Skin ulcer, Syncope
Clinical narrative: 13 days post vax, the pt developed 20-30 lesions and no fever.  3 days post vax the pt was seen for a physical and blood draw. The pt fainted 2 times, was seen in the ER and diagnosed with dehydration. No fever, vomiting or diarrhea.
Age: 51.0
Sex: M
Vaccine: TD
Symptoms: Injection site pain
Clinical narrative: The pt experienced discomfort in left deltoid where TD was given.
Age: 1.8
Sex: F
Vaccine: DTAP, HEP, IPV
Symptoms: Crying, Injection site swelling, Irritability
Clinical narrative: The child became irritable, experienced non-stop crying, developed soft ball sized swelling with left leg, thigh seen at ER. No medication given, supportive care only. Resolved in 4-5 days.
Age: 15.0
Sex: F
Vaccine: MMR
Symptoms: Headache, Lethargy, Nausea, Vomiting
Clinical narrative: Mom said that pt became lethargic, 1 hour, post vax. Then she developed nausea, vomiting and a bad headache. There is no fever on 9/7/01. Follow-up call to mother. She stated that the pt was back in school today but still has a headache. No nausea and vomiting. No doctor follow-up was done.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Injection site oedema, Injection site warmth, Malaise, Urticaria
Clinical narrative: One day post vax, the pt't arm began swelling, to th axilla, was hot to the touch, red with small hives No  fever was given noted. The pt also experienced malaise. The pt is beginning to recover. No diarrhea nor a fever.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Amnesia, Anorexia, Eye disorder, Feeling abnormal, Pruritus
Clinical narrative: Parent called to report, after her child had received Hep-B at 09:30. He went to school and completed a day of school but told parent he "felt weird; not like himself" all day. He complained of loss of memory, shakiness and spilling liquids while at school. By 19:30, he complained of itchy eyes and loss of appetite. He went to ER and his only treatment was to take Benadryl po.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Tremor
Clinical narrative: Parent called to report, after her child had received Hep-B at 09:30. He went to school and completed a day of school but told parent he "felt weird; not like himself" all day. He complained of loss of memory, shakiness and spilling liquids while at school. By 19:30, he complained of itchy eyes and loss of appetite. He went to ER and his only treatment was to take Benadryl po.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt awoke the next morning, post vax, with right arm swollen from his shoulder to his elbow. His arm was red and hot to touch. The child was seen at Urgent Care and treated with Cephalexin and hydroxyzine. On Monday, the child's arm was still swollen.
Age: 4.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia
Clinical narrative: Pt had varivax injection on 3/3/98 and on 9/20/01 he developed low-grade fever and chickenpox. Saw doctor on 9/21/01and was treated with Zovirax.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: On 8/21/01, client came to clinic for TB test reading. She stated that MMR site had began to redden and swell within a day, post vax. The area of right arm was examined and was warm to the touch. There was a 1 1/2" X 2" area that was pink per caller, noted below injection site. Pt was advised to seek medical care. On 8/27/01, received telephone call from pt stating the she was unable to see physician (clinic closed) but the area was less warm and smaller in size.
Age: 1.6
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt developed erythematous area about 20cm X 15cm in right thigh, around the injection site. No swelling but mildly warmer on the right more than on the left. Not pruritic area. Skin is smooth with no fluctuation. Treated with Duricef 250/5ml 3.5ml po BID.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash
Clinical narrative: Pt received Hep-B (dose #3) at 10:13 on 9/20/01. Pt returned at 19:27, complaining of a rash and itching. Rash was on the abdomen, arms and back. Temperature was 98.2F. Pt was treated with Benadryl 25mg 1 po q6 hours X 5 days and Claritin 1 po q day X 7 days.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Pyrexia, Similar reaction on previous exposure to drug, Wheezing
Clinical narrative: Pt developed wheezing and increased temperature to 102F after 2nd DTAP, IPV and Comvax. Pt had hives after the 1st DTAP, IPV and Comvax.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Pt's right leg was swollen, red, warm to touch and with a knot.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Bacterial infection, Pneumonia
Clinical narrative: On 5/21/01, six days post vax, the child was found dead in her crib. Preliminary autopsy cause of death was attributed to "sudden unexplained non-traumatic infant death." The autopsy report was amended on 8/15/01 to "acute streptococcus pneumonia. Follow-up info received on 09/10/2001 revealed that on 05/20/2001, the child was fussy at bedtime and was given a dose of Tylenol.
Age: 1.0
Sex: F
Vaccine: PNC
Symptoms: Bacterial infection, Bone disorder, Pyrexia, Red blood cell sedimentation rate increased, White blood cell count increased
Clinical narrative: A 12 month old female completed the series of Prevnar injections in February 2001. The patient was not receiving concomitant therapy and she had no preexisting illnesses at the time of vaccination. In July 2001 (at the age of 17 months), the patient was hospitalized for Streptococcal pneumoniae osteomyelitis. An unspecified culture was positive for streptococcus pneumoniae. Follow-up information received on 08/03/01 indicated that the child was previously well and considered up to date on her Prevnar vaccinations having received her 3rd dose in 02/01. She presented in June 2001, with a 2 day history of fever between 102 and 103 deg. F. and favoring her left leg. She was seen in the ER on day 2 of illness where examination revealed a blood culture positive for Streptococcus pneumoniae, "mildly" elevated white blood cell count with no shift, and increased erythrocyte sedimentation rate. Ultrasound of hip on day 2 and bone scan on day 3 were negative; however, an MRI on day 4 was positive. A repeat blood culture on day 5 was negative. She was initially treated with IV nafcillin, then switched over to ceftriaxone for 1 week. She then began oral amoxicillin with plans to continue treatment for three weeks. As of 08/03/01, plans were to repeat the bone scan at the end of antibiotic treatment for further evaluation. The S. pneumoniae isolate was not serotyped; however, arrangements were being made to have this done.  Follow-up information was received from the original reporter on 08/15/01, which provided the lot numbers and dates of Prevnar doses administered. Also, the patient's birthday was provided; the patient was 15 months of age (several days shy of 16 months) when the events occurred (06/17/01). The following patient had no preexisting illnesses at the time of the vaccination and had no history  of adverse events following previous vaccination. The reporter also noted that the patient received Varivax (MSD) and Engerix B (SKB) vaccines within 4 weeks of receiving Prevnar, but dates were not provided. The patient recovered.
Age: 1.25
Sex: F
Vaccine: HIBV, PNC
Symptoms: Apnoea, Cardiac arrest, Choking, Cyanosis, Eye movement disorder
Clinical narrative: On 3/6/01 the pt developed choking, eyes rolling to the back of the head, and tremors in all extremities. She also appeared to stop breathing with perioral cyanosis. She received cardiopulmonary resuscitation and was transported to the ER. Upon arrival to the ER she had a fever of 102.
Age: 1.25
Sex: F
Vaccine: HIBV, PNC
Symptoms: Tremor
Clinical narrative: On 3/6/01 the pt developed choking, eyes rolling to the back of the head, and tremors in all extremities. She also appeared to stop breathing with perioral cyanosis. She received cardiopulmonary resuscitation and was transported to the ER. Upon arrival to the ER she had a fever of 102.
Sex: U
Vaccine: PNC
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain
Clinical narrative: A physician reported that a young child received the 1st dose of Prevnar and subsequently developed an injection site reaction characterized by erythema, induration, swelling, and tenderness. No fever was noted. The induration was described as "persistent", lasting more than 7 days. The child recovered. The reporter felt this reaction was medically important. MANUFACTURER'S COMMENT: The reporter indicated that 2 children experienced this event; however, they are not presently identifiable. An additional report will be generated when identifying information is provided.
Age: 0.4
Sex: F
Vaccine: PNC
Symptoms: Bacterial infection, Laboratory test abnormal, Meningitis
Clinical narrative: A 5 month old infant received a 2nd dose of Prevnar. Subsequently, the infant was hospitalized with a diagnosis of pneumococcal meningitis. No further info was available at the date of this report. Follow up info received from the physician on 07/23/01, indicated that a 5 month old female received an injection of Prevnar on 05/16/01. On 05/28/01, the child was hospitalized and diagnosed with pneumococcal meningitis. Blood and cerebral spinal fluid cultures were positive for Streptococcus pneumoniae. Gram positive cocci were seen in a gram stain of cerebral spinal fluid. A bacterial antigen panel was positive for Streptococcus pneumoniae. Lumbar puncture results on 05/28/01, showed white blood cells at 50/ cu mm, total protein of 329 mg/dl., neutrophils at 46 %, bands at 37 %, Lymphocytes at 15 % and monocytes at 1 %. The infant recovered.
Age: 5.0
Sex: U
Vaccine: PNC
Symptoms: Meningitis
Clinical narrative: A company representative reported that a 5 year old child was admitted to the hospital with a diagnosis of pneumococcal meningitis. No further information was available at the date of this report.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Bacterial infection, Sepsis
Clinical narrative: On 10/12/00 the child was hospitalized for pneumococcal sepsis. A blood culture was obtained on 10/12/00 yielded the presence of streptococcus pneumoniae. The child recovered and was discharged seven days later. This case has been determined to be a duplicate of report HQ2678324OCT2000. A physician reported that a 4 month old male received his first dose of Prevnar, Hib-Titer, Acel-immune, IPV (manufact unknown), and his second dose of Recombivax-HB(MSD) vaccines on 21-Aug-2000.
Age: 1.5
Sex: M
Vaccine: RV
Symptoms: Viral infection
Clinical narrative: The pt experienced rotavirus three months after vax. He was hospitalized twice. He almost died. No medical history and no further details were provided. Follow up info received on 11/9/01, upon review of the case, the recovery status was changed to "unknown."
Sex: U
Vaccine: PNC
Symptoms: Discomfort
Clinical narrative: A healthcare professional reported that an unspecified number of pts experienced site "discomfort", subsequent to Prevnar administration. The reporter considered the event due to the needle, not the vaccine. No further information was available at the time of this report.
Age: 0.5
Sex: M
Vaccine: DTAP, PNC
Symptoms: Irritability, Lethargy, Urticaria
Clinical narrative: A physician reported that a 6 month old male received his 1st dose of Prevnar and his 3rd dose of DTAP vaccines on 3/15/01. That day, he developed hives, irritability and lethargy. He was seen in Urgent Care and treated with diphenhydramine. He recovered.
Sex: U
Vaccine: PNC
Symptoms: Injection site swelling, Rash macular
Clinical narrative: A nurse reported that a child received an injection of Prevnar and subsequently, developed a "red lacey rash all over". The child also developed swelling at the injection site. No further information was available at the date of this report. The reporter declined to provide information for follow-up investigation.
Age: 8.0
Sex: F
Vaccine: PNC
Symptoms: Immune system disorder
Clinical narrative: A mother reported that her 8 year old daughter with common variable immunodeficiency received Prevnar "in the standard procedural way for a child on gamma globulins". Following immunization, her serum antibody value was measured to be lower than her pre-immunization value. She was seen by the physician who had the lab run the test again. No further information was available at the date of this report.
Sex: U
Vaccine: PNC
Symptoms: Dysphonia
Clinical narrative: A pharmacist reported that a child received a dose of Prevnar and subsequently developed hoarseness. The child recovered. No further information was available at the date of the report.