chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a female who was a premature infant with a history of seizures as an infant (no current seizure history) who was vaccinated with a first dose of GARDASIL. Subsequently, the patient had a seizure the following day. The patient sought unspecified medical attention. At the time of the report the patient's outcome was recovered. Upon internal review, the seizure was considered to be an other important medical event. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Convulsion, Syncope
Clinical narrative: Information has been received from a physician concerning some patients who were vaccinated with a dose of GARDASIL. After receiving GARDASIL the patients fainted or had seizures. At the time of the report, it was unknown if the patients had recovered from the events. Upon internal review, seizures were considered to be an other important medical event. No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Foetal disorder, Pregnancy test
Clinical narrative: Information has been received through a Merck pregnancy registry from a 27 year old female with penicillin allergy and no pertinent medical history who on 20-AUG-2007 was vaccinated with a single dose of GARDASIL.  There was no concomitant medication.  She became pregnant in September 2007.  A pregnancy test was performed (result not provided).  Her LMP was 08-SEP-2007.  Expected date of delivery was 14-JUN-2008.  The patient did not have any adverse symptoms as a result of receiving GARDASIL.  She did not have any additional doses of GARDASIL.  On 11-JUN-2008 the patient gave birth to a baby girl.  The child had been diagnosed with congenital cataracts in both eyes.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Premature labour, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from the Merck pregnancy registry for GARDASIL from a physician concerning a 17 year old female who on 16-JUL-2007 was first vaccinated with 0.5 ml, GARDASIL.  Concomitant therapy included albuterol which the patient used infrequently.  On 17-SEP-2007, the patient presented to the office to get her second dose of GARDASIL but a urine test showed positive HCG and the client was pregnant (LMP 18-AUG-2007).  The second dose of GARDASIL was not administered.  Followup phone call information from a pediatrician reported that the patient had not been back to the pediatrician's office since she found out she was pregnant.  However, the pediatrician was able to report that via their tracking system, it appeared that the patient was still pregnant and had an upcoming appointment.  She also reported the patient had been admitted to the hospital for pre-term labor from 28-MAY-2008 to 31-MAY-2008.  No outcome information was reported.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Drug exposure during pregnancy, Pregnancy test
Clinical narrative: Initial and follow-up information has been received through the Merck pregnancy registry from a 23 year old female, with no pertinent medical history, who on 19-APR-2007 was vaccinated IM with a third dose of GARDASIL.  There was no concomitant medication.  Subsequently, the patient became pregnant.  Date of conception was reported as 31-MAY-2007.  The patient reported a beta-human chorionic gonadotropin test (unspecified) was performed.  There were no adverse reactions.  At the time of the report the outcome of the patient was unknown.  On 29-FEB-2008 the patient gave birth to a liveborn infant via cesarean section.  The indication for the cesarean section was not provided.  The infant was healthy, normal, and delivered at full term.  Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal injury, Alpha 1 foetoprotein amniotic fluid normal, Anaemia, Caesarean section, Delivery
Clinical narrative: Information has been received from a consumer, a 21 year old female, through the Merck Pregnancy Registry for GARDASIL, who on 05-APR-2007 was vaccinated with a first dose of GARDASIL (Lot # unknown), and on 18-SEP-2007 she was vaccinated with a second dose of GARDASIL (Lot # unknown). On 21-OCT-2007 she found out she was pregnant after the second dose. The consumer had performed two pregnancy tests, one was done on 22-OCT-2007 and then another on 08-NOV-2007. Both tests came back positive (estimated LMP 23-AUG-2007). Unspecified medical attention was sought. The consumer reported that she is 29 weeks pregnant. Follow up information has been received from a certified nurse midwife. The patient's significant past medical history was benign. The patient had one previous pregnancy which was a full term delivery. The patient's LMP was confirmed to be 19-AUG-2007 and her estimated delivery date to be 25-MAY-2008. On 04-JAN-08 the patient was started on prenatal vitamins (unspecified) for pregnancy/nutrition. The nurse midwife indicated that the following labs/diagnostics studies were performed: on an unspecified date for Hepatitis C Antibody (tested reactive); on an unspecified date recombinant immunoblot assay (RIBA) (negative); on 04-JAN-2008 alpha-fetoprotein (AFP) (negative) and on 10-JAN-2008 an ultrasound for anatomay (WNL, confirmed dates). On 10-MAR-2008 the patient had a 24 hour urine test and liver function tests which were within normal levels. On 10-MAR-2008, the patient also had a hematocrit of 30, which was done because of anemia. The reporter noted that on 24-MAR-2008, at 31 weeks gestation, the patient fell and hit her abdomen. Labs and electronic fetal monitoring were within normal at that time. On1 5-APR-2008 the patient was started on ED Cyte F for the anemia. No product quality complaint was involved. On 23-MAY-2008, at 39 5/7 weeks from the LMP, the patient underwent primary caesarean section for multiple variable fetal heart decelerations shown on electronic fetal monitoring, and delivered a full-term healthy, normal baby with no congenital anomalies. The baby's weight: 8lbs 12 ozs; length; 20 1/4 inches; Apgar score: 8/9. Upon internal review, the patient's caesarean section due to multiple fetal heart decelerations was considered to be an other important medical event. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Fall, Haematocrit decreased, Hepatitis C antibody negative, Immunology test normal
Clinical narrative: Information has been received from a consumer, a 21 year old female, through the Merck Pregnancy Registry for GARDASIL, who on 05-APR-2007 was vaccinated with a first dose of GARDASIL (Lot # unknown), and on 18-SEP-2007 she was vaccinated with a second dose of GARDASIL (Lot # unknown). On 21-OCT-2007 she found out she was pregnant after the second dose. The consumer had performed two pregnancy tests, one was done on 22-OCT-2007 and then another on 08-NOV-2007. Both tests came back positive (estimated LMP 23-AUG-2007). Unspecified medical attention was sought. The consumer reported that she is 29 weeks pregnant. Follow up information has been received from a certified nurse midwife. The patient's significant past medical history was benign. The patient had one previous pregnancy which was a full term delivery. The patient's LMP was confirmed to be 19-AUG-2007 and her estimated delivery date to be 25-MAY-2008. On 04-JAN-08 the patient was started on prenatal vitamins (unspecified) for pregnancy/nutrition. The nurse midwife indicated that the following labs/diagnostics studies were performed: on an unspecified date for Hepatitis C Antibody (tested reactive); on an unspecified date recombinant immunoblot assay (RIBA) (negative); on 04-JAN-2008 alpha-fetoprotein (AFP) (negative) and on 10-JAN-2008 an ultrasound for anatomay (WNL, confirmed dates). On 10-MAR-2008 the patient had a 24 hour urine test and liver function tests which were within normal levels. On 10-MAR-2008, the patient also had a hematocrit of 30, which was done because of anemia. The reporter noted that on 24-MAR-2008, at 31 weeks gestation, the patient fell and hit her abdomen. Labs and electronic fetal monitoring were within normal at that time. On1 5-APR-2008 the patient was started on ED Cyte F for the anemia. No product quality complaint was involved. On 23-MAY-2008, at 39 5/7 weeks from the LMP, the patient underwent primary caesarean section for multiple variable fetal heart decelerations shown on electronic fetal monitoring, and delivered a full-term healthy, normal baby with no congenital anomalies. The baby's weight: 8lbs 12 ozs; length; 20 1/4 inches; Apgar score: 8/9. Upon internal review, the patient's caesarean section due to multiple fetal heart decelerations was considered to be an other important medical event. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Liver function test normal, Pregnancy test positive, Ultrasound scan normal, Urine analysis normal
Clinical narrative: Information has been received from a consumer, a 21 year old female, through the Merck Pregnancy Registry for GARDASIL, who on 05-APR-2007 was vaccinated with a first dose of GARDASIL (Lot # unknown), and on 18-SEP-2007 she was vaccinated with a second dose of GARDASIL (Lot # unknown). On 21-OCT-2007 she found out she was pregnant after the second dose. The consumer had performed two pregnancy tests, one was done on 22-OCT-2007 and then another on 08-NOV-2007. Both tests came back positive (estimated LMP 23-AUG-2007). Unspecified medical attention was sought. The consumer reported that she is 29 weeks pregnant. Follow up information has been received from a certified nurse midwife. The patient's significant past medical history was benign. The patient had one previous pregnancy which was a full term delivery. The patient's LMP was confirmed to be 19-AUG-2007 and her estimated delivery date to be 25-MAY-2008. On 04-JAN-08 the patient was started on prenatal vitamins (unspecified) for pregnancy/nutrition. The nurse midwife indicated that the following labs/diagnostics studies were performed: on an unspecified date for Hepatitis C Antibody (tested reactive); on an unspecified date recombinant immunoblot assay (RIBA) (negative); on 04-JAN-2008 alpha-fetoprotein (AFP) (negative) and on 10-JAN-2008 an ultrasound for anatomay (WNL, confirmed dates). On 10-MAR-2008 the patient had a 24 hour urine test and liver function tests which were within normal levels. On 10-MAR-2008, the patient also had a hematocrit of 30, which was done because of anemia. The reporter noted that on 24-MAR-2008, at 31 weeks gestation, the patient fell and hit her abdomen. Labs and electronic fetal monitoring were within normal at that time. On1 5-APR-2008 the patient was started on ED Cyte F for the anemia. No product quality complaint was involved. On 23-MAY-2008, at 39 5/7 weeks from the LMP, the patient underwent primary caesarean section for multiple variable fetal heart decelerations shown on electronic fetal monitoring, and delivered a full-term healthy, normal baby with no congenital anomalies. The baby's weight: 8lbs 12 ozs; length; 20 1/4 inches; Apgar score: 8/9. Upon internal review, the patient's caesarean section due to multiple fetal heart decelerations was considered to be an other important medical event. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Syncope
Clinical narrative: Information has been received from an office manager in a physicians office concerning a female (age unreported) who on an unspecified date, was vaccinated with a dose of GARDASIL, no lot number reported.  It was reported that within 5 minutes of being vaccinated with GARDASIL, the patient fainted and then also experienced convulsions.  Unspecified medical attention was sought.  At the time of this report the outcome was unknown.  Upon internal review convulsions were considered an other important medical event.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin, Drug exposure during pregnancy, Progesterone, Ultrasound scan
Clinical narrative: Information has been received from a licensed practical nurse through the Merck Pregnancy Registry concerning an 18 year old female who on 23-APR-2008 was vaccinated with a first dose of GARDASIL, 0.5mL intramuscularly (lot# 0152X).  There was no concomitant medication.  The patient became pregnant after receiving the first dose of GARDASIL.  The patient's last menstrual period was 11-APR-2008.  On 28-MAY-2008 the patient had labs and diagnostic studies including HCG and progesterone levels and ultrasound.  On 01-JUN-2008 the patient was hospitalized for a dilatation and curettage (D&C) because she miscarried.  The reason for the miscarriage was unknown, but believed to be spontaneous.  She was discharged the same day.  The patient's estimated due date was 16-JAN-2009.  On 16-JUN-2008, the patient received a second dose of GARDASIL (lot# 0250X).  No further detail was provided.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Uterine dilation and curettage
Clinical narrative: Information has been received from a licensed practical nurse through the Merck Pregnancy Registry concerning an 18 year old female who on 23-APR-2008 was vaccinated with a first dose of GARDASIL, 0.5mL intramuscularly (lot# 0152X).  There was no concomitant medication.  The patient became pregnant after receiving the first dose of GARDASIL.  The patient's last menstrual period was 11-APR-2008.  On 28-MAY-2008 the patient had labs and diagnostic studies including HCG and progesterone levels and ultrasound.  On 01-JUN-2008 the patient was hospitalized for a dilatation and curettage (D&C) because she miscarried.  The reason for the miscarriage was unknown, but believed to be spontaneous.  She was discharged the same day.  The patient's estimated due date was 16-JAN-2009.  On 16-JUN-2008, the patient received a second dose of GARDASIL (lot# 0250X).  No further detail was provided.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Syncope, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse mid-wife concerning a 20 year old female who on unspecified dates was vaccinated with a first and second dose of GARDASIL (lot number, injection site and route not reported). The patient fainted and had a "seizure like" reaction after vaccinations. On an unspecified date, the patient was vaccinated with a third dose of GARDASIL (lot number, injection site and route not reported). On approximately 23-JUN-2008, also reported as "last week", the patient fainted and had a "seizure like" reaction. It was unknown whether the patient sought medical attention. The patient had recovered from all the events. Upon internal review "seizure like" reaction was determined to be an other important medical event. This is one of two reports received from the same source. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a medical assistant, and a physician (through the patient's mother) concerning a 22 year old female patient with hyperglycaemia who on 19-MAR-2007 was vaccinated intramuscularly with a first dose of 0.5mL GARDASIL (lot # not reported). On 14-MAY-2007 the patient was vaccinated with a second dose of GARDASIL (lot#657621/0387U); and on 11-SEP-2007 the patient was vaccinated with a third dose of GARDASIL (lot# 657868/0523U). Concomitant therapy included ibuprofen, PHENERGAN and "NARCO" (therapy unspecified). The patient's mother and the medical assistant reported that the patient experienced three seizures since receiving the GARDASIL, (timing for each seizure not specified). The mother also reported that the patient was scheduled to see a neurosurgeon. The medical assistant reported that on unspecified date, the patient recovered. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Impaired work ability, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 21 year old female who on an unspecified date was vaccinated with a first dose of GARDASIL.  On 06-MAY-2008 the patient was vaccinated IM into the deltoid with a second 0.5ml dose of GARDASIL.  The patient developed unspecified arm pain at an unspecified time after the injection and inability to raise the arm above the shoulder level which caused her disability from her work.  The patient sought treatment with a chiropractor.  At the time of the report the patient was not recovered.  The physician considered the unspecified arm pain and inability to raise the arm above the shoulder level to be disabling.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Arrested labour, Caesarean section, Drug exposure during pregnancy, Live birth
Clinical narrative: Initial and follow up information has been received from the Merck pregnancy registry for GARDASIL via a medical assistant (also reported as a nurse) concerning a 24 year old female who on 03-APR-2007 was vaccinated with the first dose of GARDASIL.  On 05-Jun-2007 the patient was vaccinated with the second dose of GARDASIL.  Concomitant therapy included prenatal vitamins (unspecified).  The patient was 9 weeks and one day pregnant.  Unknown medical attention was sought.  The patient delivered by primary cesarean section secondary to arrest of active labor at 8cm.  She delivered a healthy and normal infant at 40 weeks estimated gestational age, weighing 9 lbs. 7 oz.  Upon internal review primary cesarean secondary to arrest of active labor at 8 cm was considered to be an other important medical event.  Additional information has been requested.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Allergy test positive, Blood culture negative, Bronchiolitis, Bronchitis
Clinical narrative: Information has been received from a certified medical assistant (CMA) concerning a 10 week old male twin who on 16-JAN-2008 was vaccinated po with the first 2.0 ml dose of ROTATEQ (lot#657988/1193U).  Concomitant vaccines included PEDIARIX, PREVNAR and ACTHIB.  It was reported that on 29-JAN-2008 the patient was seen in the office when he became very fussy, spitting up, screaming if not being held, irritable and increased drooling.  Nothing was found on physical exam and the patient was treated with ZANTAC and formula change, blood tests (unspecified) were normal.  The patient was seen again on 31-JAN-2008 with no improvement, the parents had not been giving the ZANTAC.  The patient was seen again on 05-FEB-2008 with limited improvement and on 06-FEB-2008, the patient had an X-ray of the kidney, ureters and bladder, results were normal.  On 08-FEB-2008 the parents stated the patient was doing better.  On 18-FEB-2008, the patient had bronchiolitis, wet cough and wheezing.  A few days later, approximately 20-FEB-2008, patient was started on steroids and ROTATEQ was discontinued.  On 25-FEB-2008, the patient was hospitalized with bronchitis and was discharged on 01-MAR-2008.  The outcome is reported as recovered.  Additional information has been received from a physician reporting that when the patient was seen in the office on 29-JAN-2008 the biggest thing was his "extreme crankiness", a sepsis work-up was performed: blood cultures were negative, Sed rate was a little high at 27, C-reactive protein was less than 1, CBC was normal and an allergy test showed a class II allergy to milk, (reported as not that significant) and was placed on ALIMENTUM formula.  On 30-JAN-2008 and 31-JAN-2008 the patient was seen in the office and remained very cranky, a stool culture on 31-JAN-2008, negative for blood.  Intussusception was ruled out.  On 01-FEB-2008 it was reported that the patient was doing a little better.  On 05-FEB-2008, seen in the office with fussiness but "definitely improved".  On 06-FEB-2008, an abdominal x-ray was performed which was normal.  On 18-FEB-2008 the patient's "GI stuff" improved and the patient was seen for a cold.  On 20-FEB-2008 patient had a lot of congestion and wheezing.  On 25-FEB-2008, the patient was admitted to the hospital with bronchiolitis, official diagnosis was intermittent wheezing.  On 01-MAR-2008, the patient was discharged from the hospital to home of FLOVENT and albuterol PRN.  On 03-MAR-2008 patient was seen in the office, was doing well but still had wheezing.  On 10-MAR-2008 patient was seen in the office and was "doing great".  The physicians opted not to give the second dose of ROTATEQ.  A product quality complaint was not involved.  This is one of several reports from the same source.  No additional information is expected.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: C-reactive protein normal, Culture stool negative, Drooling, Full blood count normal, Infantile spitting up
Clinical narrative: Information has been received from a certified medical assistant (CMA) concerning a 10 week old male twin who on 16-JAN-2008 was vaccinated po with the first 2.0 ml dose of ROTATEQ (lot#657988/1193U).  Concomitant vaccines included PEDIARIX, PREVNAR and ACTHIB.  It was reported that on 29-JAN-2008 the patient was seen in the office when he became very fussy, spitting up, screaming if not being held, irritable and increased drooling.  Nothing was found on physical exam and the patient was treated with ZANTAC and formula change, blood tests (unspecified) were normal.  The patient was seen again on 31-JAN-2008 with no improvement, the parents had not been giving the ZANTAC.  The patient was seen again on 05-FEB-2008 with limited improvement and on 06-FEB-2008, the patient had an X-ray of the kidney, ureters and bladder, results were normal.  On 08-FEB-2008 the parents stated the patient was doing better.  On 18-FEB-2008, the patient had bronchiolitis, wet cough and wheezing.  A few days later, approximately 20-FEB-2008, patient was started on steroids and ROTATEQ was discontinued.  On 25-FEB-2008, the patient was hospitalized with bronchitis and was discharged on 01-MAR-2008.  The outcome is reported as recovered.  Additional information has been received from a physician reporting that when the patient was seen in the office on 29-JAN-2008 the biggest thing was his "extreme crankiness", a sepsis work-up was performed: blood cultures were negative, Sed rate was a little high at 27, C-reactive protein was less than 1, CBC was normal and an allergy test showed a class II allergy to milk, (reported as not that significant) and was placed on ALIMENTUM formula.  On 30-JAN-2008 and 31-JAN-2008 the patient was seen in the office and remained very cranky, a stool culture on 31-JAN-2008, negative for blood.  Intussusception was ruled out.  On 01-FEB-2008 it was reported that the patient was doing a little better.  On 05-FEB-2008, seen in the office with fussiness but "definitely improved".  On 06-FEB-2008, an abdominal x-ray was performed which was normal.  On 18-FEB-2008 the patient's "GI stuff" improved and the patient was seen for a cold.  On 20-FEB-2008 patient had a lot of congestion and wheezing.  On 25-FEB-2008, the patient was admitted to the hospital with bronchiolitis, official diagnosis was intermittent wheezing.  On 01-MAR-2008, the patient was discharged from the hospital to home of FLOVENT and albuterol PRN.  On 03-MAR-2008 patient was seen in the office, was doing well but still had wheezing.  On 10-MAR-2008 patient was seen in the office and was "doing great".  The physicians opted not to give the second dose of ROTATEQ.  A product quality complaint was not involved.  This is one of several reports from the same source.  No additional information is expected.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Irritability, Nasopharyngitis, Occult blood negative, Productive cough, Red blood cell sedimentation rate increased
Clinical narrative: Information has been received from a certified medical assistant (CMA) concerning a 10 week old male twin who on 16-JAN-2008 was vaccinated po with the first 2.0 ml dose of ROTATEQ (lot#657988/1193U).  Concomitant vaccines included PEDIARIX, PREVNAR and ACTHIB.  It was reported that on 29-JAN-2008 the patient was seen in the office when he became very fussy, spitting up, screaming if not being held, irritable and increased drooling.  Nothing was found on physical exam and the patient was treated with ZANTAC and formula change, blood tests (unspecified) were normal.  The patient was seen again on 31-JAN-2008 with no improvement, the parents had not been giving the ZANTAC.  The patient was seen again on 05-FEB-2008 with limited improvement and on 06-FEB-2008, the patient had an X-ray of the kidney, ureters and bladder, results were normal.  On 08-FEB-2008 the parents stated the patient was doing better.  On 18-FEB-2008, the patient had bronchiolitis, wet cough and wheezing.  A few days later, approximately 20-FEB-2008, patient was started on steroids and ROTATEQ was discontinued.  On 25-FEB-2008, the patient was hospitalized with bronchitis and was discharged on 01-MAR-2008.  The outcome is reported as recovered.  Additional information has been received from a physician reporting that when the patient was seen in the office on 29-JAN-2008 the biggest thing was his "extreme crankiness", a sepsis work-up was performed: blood cultures were negative, Sed rate was a little high at 27, C-reactive protein was less than 1, CBC was normal and an allergy test showed a class II allergy to milk, (reported as not that significant) and was placed on ALIMENTUM formula.  On 30-JAN-2008 and 31-JAN-2008 the patient was seen in the office and remained very cranky, a stool culture on 31-JAN-2008, negative for blood.  Intussusception was ruled out.  On 01-FEB-2008 it was reported that the patient was doing a little better.  On 05-FEB-2008, seen in the office with fussiness but "definitely improved".  On 06-FEB-2008, an abdominal x-ray was performed which was normal.  On 18-FEB-2008 the patient's "GI stuff" improved and the patient was seen for a cold.  On 20-FEB-2008 patient had a lot of congestion and wheezing.  On 25-FEB-2008, the patient was admitted to the hospital with bronchiolitis, official diagnosis was intermittent wheezing.  On 01-MAR-2008, the patient was discharged from the hospital to home of FLOVENT and albuterol PRN.  On 03-MAR-2008 patient was seen in the office, was doing well but still had wheezing.  On 10-MAR-2008 patient was seen in the office and was "doing great".  The physicians opted not to give the second dose of ROTATEQ.  A product quality complaint was not involved.  This is one of several reports from the same source.  No additional information is expected.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Respiratory tract congestion, Screaming, Vomiting, Wheezing, X-ray normal
Clinical narrative: Information has been received from a certified medical assistant (CMA) concerning a 10 week old male twin who on 16-JAN-2008 was vaccinated po with the first 2.0 ml dose of ROTATEQ (lot#657988/1193U).  Concomitant vaccines included PEDIARIX, PREVNAR and ACTHIB.  It was reported that on 29-JAN-2008 the patient was seen in the office when he became very fussy, spitting up, screaming if not being held, irritable and increased drooling.  Nothing was found on physical exam and the patient was treated with ZANTAC and formula change, blood tests (unspecified) were normal.  The patient was seen again on 31-JAN-2008 with no improvement, the parents had not been giving the ZANTAC.  The patient was seen again on 05-FEB-2008 with limited improvement and on 06-FEB-2008, the patient had an X-ray of the kidney, ureters and bladder, results were normal.  On 08-FEB-2008 the parents stated the patient was doing better.  On 18-FEB-2008, the patient had bronchiolitis, wet cough and wheezing.  A few days later, approximately 20-FEB-2008, patient was started on steroids and ROTATEQ was discontinued.  On 25-FEB-2008, the patient was hospitalized with bronchitis and was discharged on 01-MAR-2008.  The outcome is reported as recovered.  Additional information has been received from a physician reporting that when the patient was seen in the office on 29-JAN-2008 the biggest thing was his "extreme crankiness", a sepsis work-up was performed: blood cultures were negative, Sed rate was a little high at 27, C-reactive protein was less than 1, CBC was normal and an allergy test showed a class II allergy to milk, (reported as not that significant) and was placed on ALIMENTUM formula.  On 30-JAN-2008 and 31-JAN-2008 the patient was seen in the office and remained very cranky, a stool culture on 31-JAN-2008, negative for blood.  Intussusception was ruled out.  On 01-FEB-2008 it was reported that the patient was doing a little better.  On 05-FEB-2008, seen in the office with fussiness but "definitely improved".  On 06-FEB-2008, an abdominal x-ray was performed which was normal.  On 18-FEB-2008 the patient's "GI stuff" improved and the patient was seen for a cold.  On 20-FEB-2008 patient had a lot of congestion and wheezing.  On 25-FEB-2008, the patient was admitted to the hospital with bronchiolitis, official diagnosis was intermittent wheezing.  On 01-MAR-2008, the patient was discharged from the hospital to home of FLOVENT and albuterol PRN.  On 03-MAR-2008 patient was seen in the office, was doing well but still had wheezing.  On 10-MAR-2008 patient was seen in the office and was "doing great".  The physicians opted not to give the second dose of ROTATEQ.  A product quality complaint was not involved.  This is one of several reports from the same source.  No additional information is expected.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B
Clinical narrative: Information has been received from a pediatrician concerning a patient (age and gender not reported) who (on an unspecified date) was vaccinated with a third dose of RECOMBIVAX HB (lot#, injection route and site not reported).  Subsequently the patient experienced hepatitis B.  The duration and outcome were not reported.  Further information will be expected.  The pediatrician considered the patient's hepatitis B to be an other important medical event.  Other business partner numbers included: E2008-05736.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Chest pain, Chills, Dizziness, Full blood count abnormal, Leukocytosis
Clinical narrative: Information has been received from a physician concerning a 49 year old male with coronary artery disease, who on 21-JUN-2008 was vaccinated IM with a single dose of PNEUMOVAX 23.  There was no concomitant medication.  On 22-JUN-2008 the patient experienced fever, chills, myalgia, lightheadedness, and some chest pain.  The patient was hospitalized.  A complete blood count was performed and showed leucocytosis.  At the time of the report the patient was still hospitalized and was recovering.  Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 49 year old male with coronary artery disease, who on 21-JUN-2008 was vaccinated IM with a single dose of PNEUMOVAX 23.  There was no concomitant medication.  On 22-JUN-2008 the patient experienced fever, chills, myalgia, lightheadedness, and some chest pain.  The patient was hospitalized.  A complete blood count was performed and showed leucocytosis.  At the time of the report the patient was still hospitalized and was recovering.  Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pharyngeal oedema, Swelling face, Swollen tongue
Clinical narrative: Information has been received from a licensed vocational nurse concerning a 64 year old female with diabetes, hypercholesterolaemia, hypertension, emphysema, morbid obesity and drug hypersensitivity to ACTOS, codeine, DARVOCET, dexamethasone (MSD) (WAES # 0807USA00172), GLUCOPHAGE, ketoconazole, LIPITOR and ezetimibe (MSD) (WAES # 0807USA00173), who on 24-JUN-2008 was vaccinated subcutaneously in the deltoid with 0.65 ml of ZOSTAVAX (Oka/Merck) (lot # 659409/0409X).  Concomitant therapy included DYAZIDE, estradiol, HUMULIN, sitagliptin phosphate (MSD), LYRICA, NASACORT AQ, enalapril maleate (MSD) and LUNESTA.  A nurse stated that a patient's tongue, face and throat began to swell after receiving a dose of ZOSTAVAX (Oka/Merck) (Lot # 659409/0409X) on 24-JUN-2008.  The patient was treated with epinephrine and BENADRYL and the symptoms resolved.  No other symptoms or treatment reported.  The patient recovered on 24-JUN-2008.  Medical attention was sought: office visit.  There was no product quality complaint.  Upon internal review, tongue, face and throat swelling requiring epinephrine were considered other important medical events.  Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Blood culture negative, Erythema, Full blood count, Haematocrit normal, Haemoglobin normal
Clinical narrative: About 20 hrs after vaccination developed redness, swelling and pain over (R) arm vaccination site which increased in size on ED visit on 4/5/08 AM. About on AM of 7/5/08, (L) arm noted to be red as well but not as painful with concerns for cellulitis (R) arm. Given VANCOMYCIN initially, changed to CLINDAMYCIN. 7/24/08-records received for DOS 7/5/08-DX:Cellulitis of skin. Presented to ED with C/O right arm pain lasting 1 day. Erythema, swelling, tenderness associated with hotness, area of induration, with limitation in range of motion. Received vaccine 2 days prior. Observed and treated with IVAB then discharged on oral antibiotic from ED.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Lymphocyte percentage decreased, Neutrophil percentage increased
Clinical narrative: About 20 hrs after vaccination developed redness, swelling and pain over (R) arm vaccination site which increased in size on ED visit on 4/5/08 AM. About on AM of 7/5/08, (L) arm noted to be red as well but not as painful with concerns for cellulitis (R) arm. Given VANCOMYCIN initially, changed to CLINDAMYCIN. 7/24/08-records received for DOS 7/5/08-DX:Cellulitis of skin. Presented to ED with C/O right arm pain lasting 1 day. Erythema, swelling, tenderness associated with hotness, area of induration, with limitation in range of motion. Received vaccine 2 days prior. Observed and treated with IVAB then discharged on oral antibiotic from ED.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Platelet count normal, White blood cell count normal
Clinical narrative: About 20 hrs after vaccination developed redness, swelling and pain over (R) arm vaccination site which increased in size on ED visit on 4/5/08 AM. About on AM of 7/5/08, (L) arm noted to be red as well but not as painful with concerns for cellulitis (R) arm. Given VANCOMYCIN initially, changed to CLINDAMYCIN. 7/24/08-records received for DOS 7/5/08-DX:Cellulitis of skin. Presented to ED with C/O right arm pain lasting 1 day. Erythema, swelling, tenderness associated with hotness, area of induration, with limitation in range of motion. Received vaccine 2 days prior. Observed and treated with IVAB then discharged on oral antibiotic from ED.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Laboratory test, Muscular weakness, Nuclear magnetic resonance imaging brain abnormal, Paraesthesia
Clinical narrative: May 2008, my daughter started to experience bilateral leg weakness, bilateral arm weakness.  She required care as of 6/14/08 and was hospitalized by her neurologist on 6/30/08 for a complete neuro work-up.  She had numbness and tingling in all 4 extremities. Still hospitalized. 8/25/08-records received for DOS 6/30-7/4/08-DC DX: Ataxia. Seen in ED 6/16/08-C/O paresthesia started 1 week ago includes tingling. In ED on 6/18/08 with C/O numbness to arms and legs. In ED on 6/27/08 with C/O paresthesia and numbness to entire body Presented with 2 week history of weakness in upper extremities and motor weakness. Medical history is consistent with anxiety and stress. PE: bilateral upper extremity motor weakness 3/5. Transferrred to rehabilitation facility. 1/25/2010 Follow up: She continues to get symptoms from her transverse melytis from last year, thank God, not as sever but that may be because she is taking ReBit med, injection 3 x a week.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Scan brain, Urine analysis
Clinical narrative: May 2008, my daughter started to experience bilateral leg weakness, bilateral arm weakness.  She required care as of 6/14/08 and was hospitalized by her neurologist on 6/30/08 for a complete neuro work-up.  She had numbness and tingling in all 4 extremities. Still hospitalized. 8/25/08-records received for DOS 6/30-7/4/08-DC DX: Ataxia. Seen in ED 6/16/08-C/O paresthesia started 1 week ago includes tingling. In ED on 6/18/08 with C/O numbness to arms and legs. In ED on 6/27/08 with C/O paresthesia and numbness to entire body Presented with 2 week history of weakness in upper extremities and motor weakness. Medical history is consistent with anxiety and stress. PE: bilateral upper extremity motor weakness 3/5. Transferrred to rehabilitation facility. 1/25/2010 Follow up: She continues to get symptoms from her transverse melytis from last year, thank God, not as sever but that may be because she is taking ReBit med, injection 3 x a week.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Developed cellulitis at injection site.  8/5/08 Reviewed hospital medical records of 7/2-7/4/2008. FINAL DX: no d/c summary available.  Admit dx: LUE cellulitis Records reveal patient experienced LUE rash, erythema, edema & pain where had received vaccination.  Erythema noted immediately s/p vax & then spread & worsened.  Seen by MD & tx w/antibiotics.  Continued to worsen & admitted.  ID consult done.  Area at injection site indurated w/fluctuance.  Improved & d/c to home on continued oral antibiotics.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abnormal behaviour, Aggression, Anger, Confusional state
Clinical narrative: After HPV #3 reported acute behavior change, angry, confrontational, confused, trying to leave house.  Had resolved by the time she reached ER.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Dermatitis acneiform, Pruritus
Clinical narrative: Between series 1 & series 2 of anthrax vaccination soldier developed rash resembling pimples near vaccination site.  This rash appears in clusters & spread to soldiers right & left shoulders chest, back & neck.  Treated w/ 2 cycles of prednisone.  Rash remained.  Soldier takes BENADRYL to aid in relief of itchiness of rash.  Dermatologist diagnosed rash as acneiform.  Rash still present 4 month after 1st vaccination.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Blood pressure, Dizziness, Headache, Heart rate normal, Loss of consciousness
Clinical narrative: Patient was given MENACTRA & GARDASIL in the L upper arm.  Within 10 seconds she passed out for about 5 seconds. She complained of dizziness & headache when she woke up.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Oxygen saturation normal
Clinical narrative: Patient was given MENACTRA & GARDASIL in the L upper arm.  Within 10 seconds she passed out for about 5 seconds. She complained of dizziness & headache when she woke up.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site discharge, Injection site rash
Clinical narrative: Patient received VZV vaccine on 6-20-08.  The mother called back a few days later stating he had a rash on his arm where the VZV was given.  The mother was instructed to carry patient to MD.  Mother called back 7-1-08 & stated the rash is from shoulder to elbow and "oozing".
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Rotavirus vaccine given out of recommended guidelines (First rotavirus given >12 weeks of age).
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Blood pressure, Dizziness, Gaze palsy, Heart rate decreased, Hyperhidrosis
Clinical narrative: Pt felt lightheaded and fainted.  Some LUE tonic/clonic movement, eyes rolled back, head turned to R.  This episode lasted less than 10 sec.  Pt was pale, diaphoretic with nausea.  Monitor pt for 30 min.  BP 116/68 - 104/70 HR 52, lips pink, good cap. refill - color improved, sm. sip of cl. liquid.  D/C home with mom.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Nausea, Pallor, Syncope, Tonic clonic movements
Clinical narrative: Pt felt lightheaded and fainted.  Some LUE tonic/clonic movement, eyes rolled back, head turned to R.  This episode lasted less than 10 sec.  Pt was pale, diaphoretic with nausea.  Monitor pt for 30 min.  BP 116/68 - 104/70 HR 52, lips pink, good cap. refill - color improved, sm. sip of cl. liquid.  D/C home with mom.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Blood pressure, Syncope
Clinical narrative: 6/30/08 11AM Child here for physical exam.  Nurse adm. vaccines - child fainted.  Recovered quickly.  No intervention necessary.  B/P 102/66.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Erythema, Pain, Pruritus, Urticaria
Clinical narrative: Took off band aid that evening.  Started to hurt.  Next day - red, itchy, bump last few days.  Wk later it was still visible.  Red & bruised.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Dark red erythema - (L) deltoid - Tdap - painful. Dark red erythema - (R) - Hep A - painful. Dark red erythema (R) - deltoid- MCV - painful. Cold compresses - MOTRIN.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Pink-red erythema L deltoid - itching  - MCD.  Pink-red erythema L deltoid - itching - Hep A.  Cold compresses & MOTRIN.
Age: 33.0
Sex: F
Vaccine: HEPAB, TYP, YF
Symptoms: Facial palsy, Hypoaesthesia facial
Clinical narrative: Patient received a TWINRIX, typhoid and yellow fever on 7/3/08.  On 7/5/08 at 2:30pm began to feel numbness in L side of face.  Unable to blink left eye, feel teeth, tongue, lips and cheek on L side of face.  Went to emergency room, diagnosed with Bell's palsy and told it was probably due to the yellow fever vaccine.  Placed on VALTREX and prednisone.  Going out of the country in Oct 08.  7/15/08 Reviewed ER medical records of 7/5/2008. FINAL DX: Bell's palsy Records reveal patient experienced left facial numbness & weakness 3 days s/p vaccines w/gradual onset.  Difficulty smiling, watering left eye, difficulty eating/drinking.  Neuro consult done in ER.  Tx w/antivirals & tapering steroids.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy
Clinical narrative: Patient received vaccine (HPV) 2nd dose during pregnancy.  Reported to Merck 6/17/08.
Age: 18.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Unevaluable event
Clinical narrative: Patient seen in office following injection at health dept.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, Irritability, Pyrexia, Screaming
Clinical narrative: 10:00pm - fever & crying (TYLENOL, .4 x .8 alternated every 4 hrs.).  1:00pm screaming - 101.3 fever with TYLENOL given.  Gave bath - did sleep in swing - fussy afterwards.  Better following day - fever down just fussy.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Injection site erythema, Injection site induration, Injection site swelling, Rash pustular
Clinical narrative: Large, red, hard, swollen area around shot site the next day - then 2 days later I broke out with chicken pox pustules on the side of my body where I had shingles earlier.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Large, red, hard, swollen area around shot site the next day - then 2 days later I broke out with chicken pox pustules on the side of my body where I had shingles earlier.
Age: 21.0
Sex: F
Vaccine: HEPA, YF
Symptoms: Paraesthesia, Pharyngolaryngeal pain, Rash
Clinical narrative: 1) Rash on chest, arms and legs and face. 2) Tingling in hands. 3) Slight sore throat.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash pruritic
Clinical narrative: Onset 5 days after injection.  Itchy rash, small blisters under chin, on thighs.  Initially used Benadryl susp and topical.  Zovirax cream and Zovirax tablets started 7/1/08, Xyzal tablets.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Deep vein thrombosis, Pain, Pyrexia, Ultrasound scan abnormal
Clinical narrative: Saturday 14th was walking, develop pain in left calf up thigh, low grade fever, painful to walk.  Used ice, baby aspirin and Aleve.  Went to doctor's on Monday.  Doctor sent patient to get ultrasound.  After ultrasound went to ER.  DVT diagnosed using Lovenix and Coumadin for treatment.  08/14/2008 MR received from PCP. Pt presented to office 6/16/2008 with c/o popliteal tenderness. Sent for US which revealed DVT above the left popliteal vein.  Refered for anti-coagulation therapy. 9/25/08 ER record received for DOS 6/16/08 with DX: Lower extremity pain.  DVT.  Presented with pain and swelling of RLE. D/C home on Coumadin and then Lovenox. Seen 6/25 with c/o knee/leg pain on the R 2' to L leg issues. Rx-percocet.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Deep vein thrombosis, Pain in extremity, Pyrexia, Thrombosis, Ultrasound scan abnormal
Clinical narrative: Saturday 14th was walking, develop pain in left calf up thigh, low grade fever, painful to walk.  Used ice, baby aspirin and Aleve.  Went to doctor's on Monday.  Doctor sent patient to get ultrasound.  After ultrasound went to ER.  DVT diagnosed using Lovenix and Coumadin for treatment.  08/14/2008 MR received from PCP. Pt presented to office 6/16/2008 with c/o popliteal tenderness. Sent for US which revealed DVT above the left popliteal vein.  Refered for anti-coagulation therapy. 9/25/08 ER record received for DOS 6/16/08 with DX: Lower extremity pain.  DVT.  Presented with pain and swelling of RLE. D/C home on Coumadin and then Lovenox. Seen 6/25 with c/o knee/leg pain on the R 2' to L leg issues. Rx-percocet.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia, Rash erythematous, Rash generalised, Rash papular
Clinical narrative: Fever 1 day after vaccination then erythematous rash developed over entire body 2 days after vaccines given.  Coalescing papules/plaques involving face to legs.  Not itchy.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Breath holding, Gaze palsy, Musculoskeletal stiffness, Pallor, Syncope vasovagal
Clinical narrative: Patient pale with apparent vasovagel event.  (Patient unresponsive, stiff, hands positioned up toward chest, fixed eyes, held breath approximately 30-40 secs.).  Patient then was conscious, communicative and pallor improved within 1-2 minutes.  Patient symptom free and rechecked 15-20 minutes later, released home with mom.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient pale with apparent vasovagel event.  (Patient unresponsive, stiff, hands positioned up toward chest, fixed eyes, held breath approximately 30-40 secs.).  Patient then was conscious, communicative and pallor improved within 1-2 minutes.  Patient symptom free and rechecked 15-20 minutes later, released home with mom.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Fatigue, Neurological examination normal, Paraesthesia, Presyncope
Clinical narrative: Onset with fatigue, chills, (never took temperature) improved in 2 days then 6/24/08 had a near syncope and got tingling/numbness left arm.  Today, 6/26/08, symptoms resolved.  No reaction post TD.  Local reaction now resolved.
Age: 14.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Erythema
Clinical narrative: 2cm x 1cm mild red area left arm.  No treatment - to observe.