chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: HEPA, YF, HEPA, YF
Symptoms: Pyrexia
Clinical narrative: Initial report received on 14 May 2008 from a Nurse Practitioner. A 60-year-old male patient, whose past medical history included hypertension, "DM II" (Diabetes Mellitus Type II), and mononucleosis 20 years ago, had received a first intramuscular left upper arm injection of YF VAX (Lot # UF302AA) and a first intramuscular left deltoid injection of HAVRIX (manufacturer GlaxoSmithKline, Lot # AHAVB224BA) on 22 April 2008. Approximately one week post-vaccination on 30 April 2008, the patient experienced "chill" and fever of 101.0 degrees Fahrenheit that continued for three days. The temperature was confirmed to be as high as 102.0 degrees Fahrenheit. The patient had redness, swelling and firmness of approximately four inches in diameter at the injection site. The swelling and redness subsequently involved the upper arm and anterior chest wall. The patient presented to the emergency room for evaluation. Treatments received and diagnostic tests performed were not provided. Approximately five days later, on 05 May 2008, the swelling and redness was decreasing and the patient's temperature had decreased to 99.0 degrees Fahrenheit, and he was feeling much better. The following day on 06 May 2008, the patient had stated he had no temperature and the swelling on the left upper arm was continuing to resolve and he was feeling better. The patient was seen for follow-up the following day and laboratory work was completed. Three days later, the laboratory work showed the patient had "Mono" re-activated. EBV acute infection antibodies for EBV Ab VCA, IgM were 8, EBV early antigen Ab, IgG was 182, EBV Ab VCA, IgG was 2554, and EBV nuclear antigen Ab, IgG was 2235. At that time the injection site remained about the same size described as "size of 1/2 Cuban cigar." The patient continued to have fatigue at the end of the day but was able to resume some usual activities. Treatments received for the diagnosis of mononucleosis was not provided. At the time of this report, the subject's recovery status was reported as recovered; however, the recovery status of the mononucleosis was not provided.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth, Urticaria
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 10 year old male with no medical history or allergies who on 08-SEP-2000 was vaccinated with a first dose of VARIVAX (Oka/Merck) and on 08-SEP-2007 received second dose of VARIVAX (Oka/Merck) (Lot # 657715/0609U).  There was no concomitant medication.  On 26-SEP-2007, within one day of vaccination the patient developed an injection site reaction.  The patient was seen in the office on 27-SEP-2007 and at that time the reaction was described as red warm heart shaped welt 1x1 inch in the right arm.  The mother reported that the injection site reaction was worse and had improved by the office visit on 27-SEP-2007.  Unspecified medical attention was sought.  At the time of report the patient was recovering.  A product quality complaint was not involved.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Syncope
Clinical narrative: This report was received from a health professional. SERIOUNESS CRITERIA: OTHER-MEDICALLY SIGNIFICANT A 17-year-old female patient received an intramuscular injection of MENACTRA (lot number U2619AA) and a subcutaneous injection of VARIVAX (Merck, lot number 1855U) on 19 May 2008. Within five to ten minutes of vaccination, she had a syncopal episode in her physician's office lasting less than one minute. She was monitored, and subsequently recovered and was sent home. She was not ill at the time of vaccination, was not taking any concomitant medications, and had no pre-existing conditions.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bursitis, Drug administered at inappropriate site, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: Initial report was received from a health care provider on 04 January 2008. A 44-year-old female patient had received an intramuscular left deltoid injection of FLUZONE NO-PRESERVATIVE 2007-2008, lot number U2475KA, and on the day of vaccination, she complained of pain at the injection site. Two days later, the pain became severe. Corrective treatments consisted of MOTRIN. On 20 December 2007, the patient received a physician's evaluation and subsequent x-ray with negative results. According to the reporter, it was possible that the vaccine may have been administered too high in the shoulder area, possibly into the bursa. At the time of the report, the pain intensity was mild and the patient reported a shooting pain through the arm when the shoulder was abducted. The patient had pre-existing allergies to penicillin, amoxicillin and CECLOR and had not been ill at the time of vaccination. Concurrent medications included "VITORIN". At the time of the report, the patient had not recovered from the event. Follow-up information was received 14 May 2008 from a health care professional. According to the reporter, the patient had no history of arm pain. The pain at the injection site began immediately after vaccination and was severe for two days (previously reported as "two days later, pain became severe"). The pain was located high on the patient's left arm just below the joint. An X-ray of the patient's left shoulder was performed with negative results; no bone or joint abnormalities and no soft tissue calcification were seen. The patient was evaluated by a specialist and diagnosed with Subacromial Bursitis and soft tissue inflammation secondary to FLUZONE. She had been evaluated by the specialist on 04 January 2008, 21 January 2008 and 18 February 2008 (evaluation results not reported). On 06 May 2008, the patient reported to their health care provider that their "arm is good now, sometimes hurts to lift, still tender to touch". No further information was provided at the time of the report.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain, Soft tissue inflammation, Tenderness, Vaccination complication, X-ray limb normal
Clinical narrative: Initial report was received from a health care provider on 04 January 2008. A 44-year-old female patient had received an intramuscular left deltoid injection of FLUZONE NO-PRESERVATIVE 2007-2008, lot number U2475KA, and on the day of vaccination, she complained of pain at the injection site. Two days later, the pain became severe. Corrective treatments consisted of MOTRIN. On 20 December 2007, the patient received a physician's evaluation and subsequent x-ray with negative results. According to the reporter, it was possible that the vaccine may have been administered too high in the shoulder area, possibly into the bursa. At the time of the report, the pain intensity was mild and the patient reported a shooting pain through the arm when the shoulder was abducted. The patient had pre-existing allergies to penicillin, amoxicillin and CECLOR and had not been ill at the time of vaccination. Concurrent medications included "VITORIN". At the time of the report, the patient had not recovered from the event. Follow-up information was received 14 May 2008 from a health care professional. According to the reporter, the patient had no history of arm pain. The pain at the injection site began immediately after vaccination and was severe for two days (previously reported as "two days later, pain became severe"). The pain was located high on the patient's left arm just below the joint. An X-ray of the patient's left shoulder was performed with negative results; no bone or joint abnormalities and no soft tissue calcification were seen. The patient was evaluated by a specialist and diagnosed with Subacromial Bursitis and soft tissue inflammation secondary to FLUZONE. She had been evaluated by the specialist on 04 January 2008, 21 January 2008 and 18 February 2008 (evaluation results not reported). On 06 May 2008, the patient reported to their health care provider that their "arm is good now, sometimes hurts to lift, still tender to touch". No further information was provided at the time of the report.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bursitis, Drug administered at inappropriate site, Immediate post-injection reaction, Injection site pain, Pain
Clinical narrative: Initial report was received from a health care provider on 04 January 2008. A 44-year-old female patient had received an intramuscular left deltoid injection of FLUZONE NO-PRESERVATIVE 2007-2008, lot number U2475KA, and on the day of vaccination, she complained of pain at the injection site. Two days later, the pain became severe. Corrective treatments consisted of MOTRIN. On 20 December 2007, the patient received a physician's evaluation and subsequent x-ray with negative results. According to the reporter, it was possible that the vaccine may have been administered too high in the shoulder area, possibly into the bursa. At the time of the report, the pain intensity was mild and the patient reported a shooting pain through the arm when the shoulder was abducted. The patient had pre-existing allergies to penicillin, amoxicillin and CECLOR and had not been ill at the time of vaccination. Concurrent medications included "VITORIN". At the time of the report, the patient had not recovered from the event. Follow-up information was received 14 May 2008 from a health care professional. According to the reporter, the patient had no history of arm pain. The pain at the injection site began immediately after vaccination and was severe for two days (previously reported as "two days later, pain became severe"). The pain was located high on the patient's left arm just below the joint. An X-ray of the patient's left shoulder was performed with negative results; no bone or joint abnormalities and no soft tissue calcification were seen. The patient was evaluated by a specialist and diagnosed with Subacromial Bursitis and soft tissue inflammation secondary to FLUZONE. She had been evaluated by the specialist on 04 January 2008, 21 January 2008 and 18 February 2008 (evaluation results not reported). On 06 May 2008, the patient reported to their health care provider that their "arm is good now, sometimes hurts to lift, still tender to touch". No further information was provided at the time of the report.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity, Soft tissue inflammation, Tenderness, X-ray normal
Clinical narrative: Initial report was received from a health care provider on 04 January 2008. A 44-year-old female patient had received an intramuscular left deltoid injection of FLUZONE NO-PRESERVATIVE 2007-2008, lot number U2475KA, and on the day of vaccination, she complained of pain at the injection site. Two days later, the pain became severe. Corrective treatments consisted of MOTRIN. On 20 December 2007, the patient received a physician's evaluation and subsequent x-ray with negative results. According to the reporter, it was possible that the vaccine may have been administered too high in the shoulder area, possibly into the bursa. At the time of the report, the pain intensity was mild and the patient reported a shooting pain through the arm when the shoulder was abducted. The patient had pre-existing allergies to penicillin, amoxicillin and CECLOR and had not been ill at the time of vaccination. Concurrent medications included "VITORIN". At the time of the report, the patient had not recovered from the event. Follow-up information was received 14 May 2008 from a health care professional. According to the reporter, the patient had no history of arm pain. The pain at the injection site began immediately after vaccination and was severe for two days (previously reported as "two days later, pain became severe"). The pain was located high on the patient's left arm just below the joint. An X-ray of the patient's left shoulder was performed with negative results; no bone or joint abnormalities and no soft tissue calcification were seen. The patient was evaluated by a specialist and diagnosed with Subacromial Bursitis and soft tissue inflammation secondary to FLUZONE. She had been evaluated by the specialist on 04 January 2008, 21 January 2008 and 18 February 2008 (evaluation results not reported). On 06 May 2008, the patient reported to their health care provider that their "arm is good now, sometimes hurts to lift, still tender to touch". No further information was provided at the time of the report.
Age: 3.0
Sex: F
Vaccine: RV5
Symptoms: Dehydration, Diarrhoea, Gastroenteritis rotavirus, Secondary transmission, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning a female who on 08-MAY-2008 was vaccinated with one dose of ROTATEQ (lot# 659915/0015X). The nurse reported that the 39 month old sister of the patient who was vaccinated developed rotavirus gastroenteritis from her sister. The patient developed vomiting and diarrhea for 48 hours. On 12-MAY-2008 she became dehydrated and was hospitalized. The outcome was unknown. There was no product quality complaint. No other information was provided. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Dehydration, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning an approximately 25 week old male who on 21-JAN-2008 and 21-MAR-2008 was vaccinated PO with his first and second 2.0 ml doses of ROTATEQ.  On 15-MAY-2008 the patient was hospitalized due to severe dehydration due to a positive rotavirus test.  The patient was still hospitalized and was not recovered at the time of this report.  There was no product quality complaint.  No further information was provided.  Severe dehydration and positive rotavirus test were also considered to be immediately life-threatening by the physician.  A lot check has been initiated.  Additional information has been requested. 8/28/08-records received for DOS 5/15-5/17/08-DC DX:Dehydration. Rotavirus with vomiting, dehydration, diarrhea and acute gastroenteritis for one day, decreased appetite and decreased sleeping and fussy. Temperature of 101.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Carbon dioxide decreased, Dehydration, Diarrhoea, Rotavirus test positive, Vomiting
Clinical narrative: Information has been received from a physician concerning an approximately 25 week old male who on 21-JAN-2008 and 21-MAR-2008 was vaccinated PO with his first and second 2.0 ml doses of ROTATEQ.  On 15-MAY-2008 the patient was hospitalized due to severe dehydration due to a positive rotavirus test.  The patient was still hospitalized and was not recovered at the time of this report.  There was no product quality complaint.  No further information was provided.  Severe dehydration and positive rotavirus test were also considered to be immediately life-threatening by the physician.  A lot check has been initiated.  Additional information has been requested. 8/28/08-records received for DOS 5/15-5/17/08-DC DX:Dehydration. Rotavirus with vomiting, dehydration, diarrhea and acute gastroenteritis for one day, decreased appetite and decreased sleeping and fussy. Temperature of 101.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Dehydration, Rotavirus test positive
Clinical narrative: Not aware of adverse effect from vaccine.  but had 2 doses of ROTATEQ but developed vomiting and diarrhea and dehydration.  Had positive rotavirus test.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Carbon dioxide decreased, Dehydration, Diarrhoea, Rotavirus test positive, Vomiting
Clinical narrative: Not aware of adverse effect from vaccine.  but had 2 doses of ROTATEQ but developed vomiting and diarrhea and dehydration.  Had positive rotavirus test.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Cervix disorder, Drug exposure during pregnancy, Foetal disorder, Thrombosis
Clinical narrative: Initial and follow-up information have been received from a registered nurse and a licensed practical nurse through a Merck pregnancy registry concerning a 19 year old female with papanicolaou smear abnormal and a history of hypothyroidism who on 22-DEC-2009 was vaccinated with the first dose of GARDASIL (Lot #653938/0954F). On 08-MAR-2007, the patient received the second dose of GARDASIL (Lot #655618/0186U). Concomitant medication was not reported. In approximately April 2007, it was determined that the patient was pregnant. On an unspecified date, the patient had a positive urine pregnancy test. The date of the patient's last menstrual period was 19-APR-2007 and estimated delivery date is 24-JAN-2008. On 01-JUN-2007 and 17-JUL-2007, ultrasounds performed were normal. On 31-AUG-2007, was third ultrasound performed showed funneling of the cervix. On 13-SEP-2007, a fourth ultrasound showed a blood clot only. On 03-OCT-2007 at 26 weeks and 2 days of pregnancy, the patient had an emergency caesarean section performed due to the funneling of the cervix. At this time, the patient delivered two normal male infants one weighed 1 lb 12 oz and the second weighed 1 lb 13 oz with no congenital anomalies. Apgar scores were 6/7 for both infants. The infants experienced the following complications or abnormalities prematurity, bronchopulmonary dysplasia and ductus arteriosus. It was reported that there were no infections or illnesses during pregnancy and no complications during labor/delivery. The outcome and causality of these events were not reported. Upon internal review the following were considered to other important medical events: premature baby, bronchopulmonary dysplasia, caesarean section, ductus arteriosus and small for dates baby. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan abnormal, Urine human chorionic gonadotropin positive
Clinical narrative: Initial and follow-up information have been received from a registered nurse and a licensed practical nurse through a Merck pregnancy registry concerning a 19 year old female with papanicolaou smear abnormal and a history of hypothyroidism who on 22-DEC-2009 was vaccinated with the first dose of GARDASIL (Lot #653938/0954F). On 08-MAR-2007, the patient received the second dose of GARDASIL (Lot #655618/0186U). Concomitant medication was not reported. In approximately April 2007, it was determined that the patient was pregnant. On an unspecified date, the patient had a positive urine pregnancy test. The date of the patient's last menstrual period was 19-APR-2007 and estimated delivery date is 24-JAN-2008. On 01-JUN-2007 and 17-JUL-2007, ultrasounds performed were normal. On 31-AUG-2007, was third ultrasound performed showed funneling of the cervix. On 13-SEP-2007, a fourth ultrasound showed a blood clot only. On 03-OCT-2007 at 26 weeks and 2 days of pregnancy, the patient had an emergency caesarean section performed due to the funneling of the cervix. At this time, the patient delivered two normal male infants one weighed 1 lb 12 oz and the second weighed 1 lb 13 oz with no congenital anomalies. Apgar scores were 6/7 for both infants. The infants experienced the following complications or abnormalities prematurity, bronchopulmonary dysplasia and ductus arteriosus. It was reported that there were no infections or illnesses during pregnancy and no complications during labor/delivery. The outcome and causality of these events were not reported. Upon internal review the following were considered to other important medical events: premature baby, bronchopulmonary dysplasia, caesarean section, ductus arteriosus and small for dates baby. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: DTAP, HPV4, IPV, MNQ, HPV4, MNQ, TDAP
Symptoms: Headache, Inappropriate schedule of drug administration, Laboratory test, Nausea, Pain
Clinical narrative: Initial and follow up information has been received from a physician and by telephone from a registered nurse (R.N.) concerning a 17 year old female patient who on 28-APR-2008 was vaccinated with a first dose of GARDASIL lot # 659180/1758U. Concomitant therapy included DTAP-IPV, MENACTRA and ACCUTANE. On 01-MAY-2008 the patient experienced severe headache and nausea and after getting the first injection and went to the emergency room (ER). The next day, on 02-MAY-2008 she went to her physician's office and her physician sent her to the hospital. While at the hospital she was given Intravenous (IV) Fluids and narcotics for the pain. Unspecified laboratory blood work was done. In follow up telephone call to the office the nurse reported that there was no documentation regarding patient's hospitalization. No additional information was provided. The patient was reported as recovered at the time of this report. Additional information has been requested.  8/15/08 Reviewed hospital medical records of 5/2/2008. FINAL DX: acute HA; fever; vomiting; & dehydration Records reveal patient experienced severe vomiting, HA, low grade fever & dehydration.  Patient admitted to HA prior to vaccination & was on Accutane.  Also had leg pain.  Seen in PCP office where she could not stand w/o vomiting.  Had been seen in ER on 5/1 as well w/decreased urine output & dry lips.  Tx w/IVF & improved.  D/C to home on same day.
Age: 17.0
Sex: F
Vaccine: DTAP, HPV4, IPV, MNQ, HPV4, MNQ, TDAP
Symptoms: Band neutrophil percentage decreased, Blood creatinine normal, Blood culture, Blood immunoglobulin A normal, Blood pressure
Clinical narrative: Initial and follow up information has been received from a physician and by telephone from a registered nurse (R.N.) concerning a 17 year old female patient who on 28-APR-2008 was vaccinated with a first dose of GARDASIL lot # 659180/1758U. Concomitant therapy included DTAP-IPV, MENACTRA and ACCUTANE. On 01-MAY-2008 the patient experienced severe headache and nausea and after getting the first injection and went to the emergency room (ER). The next day, on 02-MAY-2008 she went to her physician's office and her physician sent her to the hospital. While at the hospital she was given Intravenous (IV) Fluids and narcotics for the pain. Unspecified laboratory blood work was done. In follow up telephone call to the office the nurse reported that there was no documentation regarding patient's hospitalization. No additional information was provided. The patient was reported as recovered at the time of this report. Additional information has been requested.  8/15/08 Reviewed hospital medical records of 5/2/2008. FINAL DX: acute HA; fever; vomiting; & dehydration Records reveal patient experienced severe vomiting, HA, low grade fever & dehydration.  Patient admitted to HA prior to vaccination & was on Accutane.  Also had leg pain.  Seen in PCP office where she could not stand w/o vomiting.  Had been seen in ER on 5/1 as well w/decreased urine output & dry lips.  Tx w/IVF & improved.  D/C to home on same day.
Age: 17.0
Sex: F
Vaccine: DTAP, HPV4, IPV, MNQ, HPV4, MNQ, TDAP
Symptoms: Blood urea decreased, Computerised tomogram normal, Dehydration, Full blood count, Haemoglobin normal
Clinical narrative: Initial and follow up information has been received from a physician and by telephone from a registered nurse (R.N.) concerning a 17 year old female patient who on 28-APR-2008 was vaccinated with a first dose of GARDASIL lot # 659180/1758U. Concomitant therapy included DTAP-IPV, MENACTRA and ACCUTANE. On 01-MAY-2008 the patient experienced severe headache and nausea and after getting the first injection and went to the emergency room (ER). The next day, on 02-MAY-2008 she went to her physician's office and her physician sent her to the hospital. While at the hospital she was given Intravenous (IV) Fluids and narcotics for the pain. Unspecified laboratory blood work was done. In follow up telephone call to the office the nurse reported that there was no documentation regarding patient's hospitalization. No additional information was provided. The patient was reported as recovered at the time of this report. Additional information has been requested.  8/15/08 Reviewed hospital medical records of 5/2/2008. FINAL DX: acute HA; fever; vomiting; & dehydration Records reveal patient experienced severe vomiting, HA, low grade fever & dehydration.  Patient admitted to HA prior to vaccination & was on Accutane.  Also had leg pain.  Seen in PCP office where she could not stand w/o vomiting.  Had been seen in ER on 5/1 as well w/decreased urine output & dry lips.  Tx w/IVF & improved.  D/C to home on same day.
Age: 17.0
Sex: F
Vaccine: DTAP, HPV4, IPV, MNQ, HPV4, MNQ, TDAP
Symptoms: Headache, Lymphocyte count decreased, Lymphocyte percentage decreased, Metabolic function test, Neutrophil count increased
Clinical narrative: Initial and follow up information has been received from a physician and by telephone from a registered nurse (R.N.) concerning a 17 year old female patient who on 28-APR-2008 was vaccinated with a first dose of GARDASIL lot # 659180/1758U. Concomitant therapy included DTAP-IPV, MENACTRA and ACCUTANE. On 01-MAY-2008 the patient experienced severe headache and nausea and after getting the first injection and went to the emergency room (ER). The next day, on 02-MAY-2008 she went to her physician's office and her physician sent her to the hospital. While at the hospital she was given Intravenous (IV) Fluids and narcotics for the pain. Unspecified laboratory blood work was done. In follow up telephone call to the office the nurse reported that there was no documentation regarding patient's hospitalization. No additional information was provided. The patient was reported as recovered at the time of this report. Additional information has been requested.  8/15/08 Reviewed hospital medical records of 5/2/2008. FINAL DX: acute HA; fever; vomiting; & dehydration Records reveal patient experienced severe vomiting, HA, low grade fever & dehydration.  Patient admitted to HA prior to vaccination & was on Accutane.  Also had leg pain.  Seen in PCP office where she could not stand w/o vomiting.  Had been seen in ER on 5/1 as well w/decreased urine output & dry lips.  Tx w/IVF & improved.  D/C to home on same day.
Age: 17.0
Sex: F
Vaccine: DTAP, HPV4, IPV, MNQ, HPV4, MNQ, TDAP
Symptoms: Neutrophil percentage increased, Pyrexia, Scan brain, Vomiting, White blood cell count normal
Clinical narrative: Initial and follow up information has been received from a physician and by telephone from a registered nurse (R.N.) concerning a 17 year old female patient who on 28-APR-2008 was vaccinated with a first dose of GARDASIL lot # 659180/1758U. Concomitant therapy included DTAP-IPV, MENACTRA and ACCUTANE. On 01-MAY-2008 the patient experienced severe headache and nausea and after getting the first injection and went to the emergency room (ER). The next day, on 02-MAY-2008 she went to her physician's office and her physician sent her to the hospital. While at the hospital she was given Intravenous (IV) Fluids and narcotics for the pain. Unspecified laboratory blood work was done. In follow up telephone call to the office the nurse reported that there was no documentation regarding patient's hospitalization. No additional information was provided. The patient was reported as recovered at the time of this report. Additional information has been requested.  8/15/08 Reviewed hospital medical records of 5/2/2008. FINAL DX: acute HA; fever; vomiting; & dehydration Records reveal patient experienced severe vomiting, HA, low grade fever & dehydration.  Patient admitted to HA prior to vaccination & was on Accutane.  Also had leg pain.  Seen in PCP office where she could not stand w/o vomiting.  Had been seen in ER on 5/1 as well w/decreased urine output & dry lips.  Tx w/IVF & improved.  D/C to home on same day.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Syncope
Clinical narrative: Information has been received from a physician concerning a 14 year old female, who, on an unspecified date, was vaccinated with a 0.5mL first dose of GARDASIL.  Subsequently, the patient experienced a syncope episode and a seizure.  The patient sought unspecified medical attention.  The patient recovered on the same day as the episode.  No product quality complaint was involved.  Upon internal review seizure was considered to be an other important medical event.  Additional information is not expected.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Hypovolaemia, Quadriplegia
Clinical narrative: Received 2-month immunizations (PEDIARIX, ACT HIB, PREVNAR, ROTATEQ) on 5/15/08.  Three days prior he had pink eye & runny nose.  No fevers.  On 5/19 our office received a call from a pediatric hospital that the child had been admitted for hyperolemic state, he had cardiac arrest.  The previous was from severe diarrhea.  6/10/08 Reviewed hospital medical records 5/17-6/4/08 FINAL DX: respiratory failure requiring intubation; cardiopulmonary arrest; seizure activities; hyponatremia; hyperkalemia; acute renal failure;&  hormone deficiency (primary aldosterone deficiency vs pseudohypoaldosteronism). Records reveal patient experienced illness while visiting from out of state.  Patient experienced incresed lethargy over 2 days, loose stools, reduced oral intake, hypotonia, dehydration, sunken fontanel, pale & ashen color, unresponsive, vomiting.  Developed bradycardia in ER.  Exam revealed sunken anterior fontanelle, pupils sluggish, poor capillary refill, unresponsive.  Tx w/bicarb & intubated.  Admitted to PICU. Extubated in 9 days, tube feedings started, Neuro, nephrology, endocrine, ST consults done.  Progressed well & d/c to f/u w/PCP & peds endocrinologist & nephrologist when returns home.
Age: 78.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Oedema peripheral, Pain in extremity
Clinical narrative: Pain-swelling in arm-red rash-Dr. prescribed antibiotic cephalexin 250 mg.  Therapy exercises-MRI-and x-rays.  Constant pain-had biofeedback for pain exercises-relaxation.  Have a large rotator cuff tear and a deltoid tear-constant pain. 6/3/08-records received-Seen on 1/16/07 C/O breast masses with history of breast cancer. Visit 3/29/07-C/O right leg pain with history of back pain for 5 1/2 months. 5/8/08 visit routine visit with C/O ecchymotic area on left arm, chronic left shoulder pain since tetanus injection 1/07.  Follow-up: Fluid collection in arm-came shortly after injectio torn deltoid muscle and massive rotator cuff tears.
Age: 78.0
Sex: F
Vaccine: TDAP
Symptoms: Rash erythematous, Rotator cuff syndrome, X-ray limb abnormal
Clinical narrative: Pain-swelling in arm-red rash-Dr. prescribed antibiotic cephalexin 250 mg.  Therapy exercises-MRI-and x-rays.  Constant pain-had biofeedback for pain exercises-relaxation.  Have a large rotator cuff tear and a deltoid tear-constant pain. 6/3/08-records received-Seen on 1/16/07 C/O breast masses with history of breast cancer. Visit 3/29/07-C/O right leg pain with history of back pain for 5 1/2 months. 5/8/08 visit routine visit with C/O ecchymotic area on left arm, chronic left shoulder pain since tetanus injection 1/07.  Follow-up: Fluid collection in arm-came shortly after injectio torn deltoid muscle and massive rotator cuff tears.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Abnormal behaviour, Activities of daily living impaired, Cough, Grand mal convulsion, Nausea
Clinical narrative: 03-27-08 Phone call from patient's mother, to JMCHD reporting the following information.  Her 4 y/o son received immunizations at JMCHD 10-01-08.  10-08-08 he started coughing had fever around 100 degree.  He continued in pre-school.  10-15-08 symptoms of nausea, vomiting, and staring.  Transported to hospital.  Grand mal seizure in ER.  Admitted to hospital.  10-16-07 Discharged with medication for seizures.  Continued to have focal type seizures as many as 40 per day with duration 45 seconds to 3 minutes.  12-10-07 admitted to JMCGH after grand mal seizure in route to hospital.  12-11-07 discharged from JMCGH.  Referral for evaluation.  01-09-08 Admission to referral.  01-12-08 Discharged from referral.  Mother states child has several behavioral changes and is presently not able to attend pre-school.  6/3/08 Reviewed hospital medical records for 12/9-12/11/2007. FINAL DX: status epilepticus Records reveal patient experienced tonic-clonic seizure x 45 min requiring multiple meds for cessation.  Had runny nose, congestion, cough & had been exposed to sick contact at school.  Improved slowly & d/c to home w/unsteady gait.  Family had antiseizure med on hand from prior seizure 2 mos ago but did not administer at home.  D/C to home w/neuro clinic f/u.  6/3/08 Reviewed hospital records for 10/15-10/16/2007. FINAL DX: new onset seizures Records reveal patient experienced HA, abdominal pain, vomiting, diarrhea & incontinent of urine.  Had staring, left sided tonic-clonic seizures lasting a couple minutes followed by left sided hemiparesis which resolved.  Seen in ER & tx w/meds.  Admitted to PICU.  No further seiures were noted & returned to baseline w/no residual weakness.  Consulted peds neuro.  D/C to home w/meds & peds neuro f/u.   6/3/08 Reviewed Neuro clinic records of 12/2007-2/2008  FINAL DX: intractable epilepsy  Records reveal patient did not have further seizures since starting the meds but had staring spells. Then in January, started having frequent seizures despite medication & was seen again in ER.  Meds changed but continued w/seizures consisting of staring, gasping for air & nonresponsive w/only occasional tonic-clonic activity.  Meds maximized & had improvement to only 2 seizures/day but longer lasting.  Meds possibly caused hyperactivity & ADHD.  Meds changed w/some improvement in hyperactivity.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Partial seizures, Pyrexia, Staring, Vomiting
Clinical narrative: 03-27-08 Phone call from patient's mother, to JMCHD reporting the following information.  Her 4 y/o son received immunizations at JMCHD 10-01-08.  10-08-08 he started coughing had fever around 100 degree.  He continued in pre-school.  10-15-08 symptoms of nausea, vomiting, and staring.  Transported to hospital.  Grand mal seizure in ER.  Admitted to hospital.  10-16-07 Discharged with medication for seizures.  Continued to have focal type seizures as many as 40 per day with duration 45 seconds to 3 minutes.  12-10-07 admitted to JMCGH after grand mal seizure in route to hospital.  12-11-07 discharged from JMCGH.  Referral for evaluation.  01-09-08 Admission to referral.  01-12-08 Discharged from referral.  Mother states child has several behavioral changes and is presently not able to attend pre-school.  6/3/08 Reviewed hospital medical records for 12/9-12/11/2007. FINAL DX: status epilepticus Records reveal patient experienced tonic-clonic seizure x 45 min requiring multiple meds for cessation.  Had runny nose, congestion, cough & had been exposed to sick contact at school.  Improved slowly & d/c to home w/unsteady gait.  Family had antiseizure med on hand from prior seizure 2 mos ago but did not administer at home.  D/C to home w/neuro clinic f/u.  6/3/08 Reviewed hospital records for 10/15-10/16/2007. FINAL DX: new onset seizures Records reveal patient experienced HA, abdominal pain, vomiting, diarrhea & incontinent of urine.  Had staring, left sided tonic-clonic seizures lasting a couple minutes followed by left sided hemiparesis which resolved.  Seen in ER & tx w/meds.  Admitted to PICU.  No further seiures were noted & returned to baseline w/no residual weakness.  Consulted peds neuro.  D/C to home w/meds & peds neuro f/u.   6/3/08 Reviewed Neuro clinic records of 12/2007-2/2008  FINAL DX: intractable epilepsy  Records reveal patient did not have further seizures since starting the meds but had staring spells. Then in January, started having frequent seizures despite medication & was seen again in ER.  Meds changed but continued w/seizures consisting of staring, gasping for air & nonresponsive w/only occasional tonic-clonic activity.  Meds maximized & had improvement to only 2 seizures/day but longer lasting.  Meds possibly caused hyperactivity & ADHD.  Meds changed w/some improvement in hyperactivity.
Age: 45.0
Sex: M
Vaccine: RAB
Symptoms: Body temperature increased, Injection site erythema, Injection site pruritus, Injection site rash, Nausea
Clinical narrative: Patient came in to donate plasma on 5-16-08 and reported having possible reaction from his rabies immunization on 5-9-08.  He stated on 5-12-08, he noticed a 2-inch red itchy rash on his left upper arm.  Tues. 5-13-08, the rash disappeared, but he had a temp. and felt nauseated.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Oedema peripheral, Pyrexia, Vomiting
Clinical narrative: Swollen red arm; fever to 102.5; vomiting
Age: 15.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fevers to 100, dizziness, red, painful, swollen L arm at injection site.  Tx - MOTRIN & BENADRYL.
Age: 0.7
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Dyskinesia, Gaze palsy, Hypotonic-hyporesponsive episode
Clinical narrative: One day after vaccine, patient had repetitive protrusion of tongue with eyes rolled backwards -> seen in ER and diagnosed with hypotonic hyporesponsive episode; no treatment, self-resolved in 1 day.
Age: 15.0
Sex: M
Vaccine: HEPA
Symptoms: Wrong technique in drug usage process
Clinical narrative: 3rd Hep A vaccine given - 2nd dose was not 'chirped" - error discovered after the fact.
Age: 6.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Left arm red warm swollen and itchy from elbow to vaccination site.  Apply warm compress BENADRYL Q 9 hours PRN or ZYRTEC Q 24 hours PRN.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Blood heavy metal test, Childhood disintegrative disorder, Injection site mass, Pyrexia
Clinical narrative: High fever, lump in leg for over a month, stopped reaching milestone within a month, now has autism. Undergoing detox, 24hrs/wk of therapy. 7 months old at time of reaction.  12/8/08 Reviewed psychological evaluation of 07/17/2008. FINAL DX: PDD, global developmental delay Records reveal patient experienced delayed & atypical development, social & communication deficits, sterotyped repetitive play.  Recommended for increased early intervention services & additional testing.  1/23/09 Received PCP medical records of 1/7/2009. FINAL DX: delayed developmental milestones, motor hypotonia, cerebral palsy, speech delay, myopathy, ?ASD Records reveal patient recently in ER for dehydration secondary to emesis triggered by chelation therapy.  Hx of night time seizures & unable to walk following AM.  Being f/u w/neuro. Also referred for genetics, rehab & neuro 2nd opinion prior to medication for seizures.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Hypoaesthesia, Induration, Injection site pain, Injection site swelling, Oedema peripheral
Clinical narrative: Arm hot, swelled and had knot.  Numbness & tingling in arm until knot dissolved.  3/26/08 reported swelling/tenderness at site.  4/7/08 numbness tingling in arm.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Paraesthesia, Skin warm
Clinical narrative: Arm hot, swelled and had knot.  Numbness & tingling in arm until knot dissolved.  3/26/08 reported swelling/tenderness at site.  4/7/08 numbness tingling in arm.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left thigh swollen, site of vaccine also slightly red and raised and mildly tender
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Convulsion, Loss of consciousness
Clinical narrative: 2 days after MMR vaccine was given patient lost consciousness and, possibly had a mild seizure.
Age: 2.0
Sex: M
Vaccine: IPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: IPV vaccine given at wrong time
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Oedema peripheral
Clinical narrative: 2nd day after shots, mom noticed kept scratching his lefty arm. Mom noticed red area red raised, spread thru-out day, kept scratching, entire left upper arm red
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Itching, swollen, pain, rash, redness at injection site (L) arm.
Age: 18.0
Sex: M
Vaccine: MMR
Symptoms: Parotitis
Clinical narrative: (L) Parotitis
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Generalised erythema, Rash morbilliform
Clinical narrative: 12 mo female seen 14 days after MMR with hx rash on set 2 days prior. Exam revealed well appearing afebrile child with generalized erythematous macular measles like rash
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Akinesia, Injection site pain, Injection site swelling
Clinical narrative: Swelling to inj site, pain unable to move arm
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Local reaction, Skin warm, Swelling, Tenderness
Clinical narrative: Local reaction (swelling, warmth, tenderness) <24 hr after vaccination. Tx with warm packs, TYLENOL
Age: 18.0
Sex: F
Vaccine: UNK
Symptoms: Anxiety, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Within 3 h of injection, client noted "terrible rash", "itchy, red" approx 10 cm around at site of inj. Had "anxiety attack" on noticing rash. No Rx at ER visit. MD "go home, take med for anxiety and that she not get a third GARDASIL. She first said she had not (anxiety) meds but then stated she took "a XANAX". She also used an "itch cream" on the rash. Rash and anxiety resolved. She reports not having had a reaction to the first GARDASIL.
Age: 21.0
Sex: F
Vaccine: ANTH
Symptoms: Rash, Swelling
Clinical narrative: Patient made appt in clinic next day after appt. Had rash upper torso. Had swelling that was aleviated with Benadryl. Could not conclude that reaction was not from Anthrax
Age: 11.0
Sex: U
Vaccine: TDAP, VARCEL
Symptoms: No adverse event
Clinical narrative: No adverse events reported. Child inadvertently given booster without consent of parent.
Age: 0.4
Sex: F
Vaccine: HIBV, RV5
Symptoms: Screaming
Clinical narrative: Patient was in for immunization on 01/25/08. One hour after receiving shots, child had inconsolable screaming for 9 hours. Child called PCP at 3am in morning; Dr said child had a reaction to shots, and to tell Health Dept when she brought infant book for next shots. Child was also seen in Dr's office morning after shots. Reported to health Dept 4/7/08
Age: 19.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling in left deltoid where shot was given, approximately 10cm long x 7cm wide x 3cm deep. Red, warm to touch, extended down arm to elbow, painful to move and to touch. Instructed to apply cool compress, if increases remove compress. Referred to physician. Analgesics as needed. Saw MD, diagnosed with possible infection, Started on PREDNISONE and BACTRIM. Improved on 4/11/08, able to move and without pain, swelling and redness decreased.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Blood test, Injection site nodule, Injection site swelling, Rash
Clinical narrative: After leaving clinic, child's right arm was swollen with a nodule where an immunization was given, broke out with hives on trunk, back, arms; was taken to ER and given BENADRYL, no circled nodule to watch how large it got; right arm was red, hot and swollen
Age: 18.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Dyspnoea, Hypoventilation, Lethargy, Pyrexia
Clinical narrative: Mo. called reported patient had. TDap. and HPV#1 on 3/3/08; Is currently running fever lethargic; and having trouble breathing/swallowing, Instructed to go directly to ER or PCP which ever closer and return call to report.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: One week post vaccination, became uncomfortable with severe itching around front and right side of waist. Skin appears normal.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, and warmth at injection site. Left deltoid - "more than normal"
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Client was diagnosed, by his PCP, with shingles one week post receipt of ZOSTAVAX.  (Client contacted health dept 1/26/08 via email; then unavailable until 2/13/08 for further contact).
Age: 41.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Vaccines administered on 1-25-08. Patient went to ER that evening for swelling at injection site and redness on upper arm.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Musculoskeletal chest pain
Clinical narrative: Joint pain - chest wall pain.  Joint pain is constant, not relieved by IBUPROFEN.  6/3/08 Reviewed OB/GYN medical records & vax records. FINAL DX: probable hypersensitivity to Gardisil. Vax records reveal 2nd HPV 0052Y given RUE 3/1/08.  Patient had been on Yasmin & then was switched to some other BCP.  Well for both doses.  5/27/08 reports that patient experienced constant joint pain after 1st HPV along w/chest pain.  Seen by pediatrician & dx w/chest wall pain.
Age: 1.01
Sex: M
Vaccine: FLU3, HEPA, MMR
Symptoms: Autism, Gastrointestinal disorder, Rash generalised, Social avoidant behaviour
Clinical narrative: The adverse symptoms my child received after the MMR injection was a huge rash all over his body then 5-days later, loss of speech & gastrointestinal difficulties, & loss of social withdrawal-autism.  5/29/2008 Multidisciplinary eval received dated 3/31/2008 with DX:  Speech Delay, Developmental Delay, PDD-Nos. On the Bayley Scales of Infant Development pt scored in the upper limit of moderately autistic range of autism spectrum disorders. Initially referred due to lack of speech aquisition (report states child has had no meaningful speech) but also had cognitive and social abnormalities.  /20/2008 Office records received from PCP with normal WCC 10/25/06. on 5/3/07 WCC Assessment:Well child. WCC 10/29/07 with vocab of 10 words at 2 yr check. Language delay noted at 2/28/08 visit. Follow-up: The residual symptoms that are related to the vaccine shot patient received are loss of speech and a regressive developmental disorder. Patient has pervasive developmental disorder not otherwise specified <PDD-NOS> known as autism spectrum. Patient received one hundred and twenty-five times his allowable exposure to mercury from vaccines in a single day.
Age: 9.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: PT. had ZNC-VZV vacc. in this office at 4 4 08.  Date of first vacc. 5/25/01.  Pt came in my office at 5/21 08 with HO 3 days itchy rash all over body more than 50.  No fever.
Age: 35.0
Sex: M
Vaccine: SMALL
Symptoms: Infection, Injection site infection
Clinical narrative: Secondary infection of smallpox vaccination site.
Age: 42.0
Sex: M
Vaccine: SMALL
Symptoms: Chest discomfort, Chest pain, Electrocardiogram normal
Clinical narrative: Developed atypical chest pain 1 day following receipt of SPV. Chest pain waxed and waned over next couple of days and patient was seen in ER on 11 April with normal exam. No associated symptoms or radiation. CP described as "little tightness in my chest...not really painful, but more bothersome". Noted burning quality that felt like heartburn, but different from heartburn in duration compared to previous heartburn episodes. No improvement of pain after receipt of IM TORADOL and po MYLANTA in ER. Chest pain did not change with changes in position or with deep breaths. (Patient sought evaluation on at least 2 other occasions for continued chest pain over next several weeks.)
Age: 11.0
Sex: M
Vaccine: UNK
Symptoms: Lymphadenopathy
Clinical narrative: Significant axillary right swelling (?edema) on side with TDaP and Hep A.  24 hours later and increased over 24 hour noted some shotty axillary adenopathy.