chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Drug exposure during pregnancy, Oligohydramnios, Pregnancy test positive, Ultrasound scan
Clinical narrative: Information has been received from a certified nurse midwife concerning a 23 year old pregnant female who is bipolar and has a history of depression, anxiety, abnormal pap test and had a loop electrosurgical excision procedure. On 02-NOV-2007 the patient was vaccinated IM with the first dose of GARDASIL vaccine (lot # 658563/1063U). On 09-JAN-2008 the patient was vaccinated IM with the second dose of GARDASIL vaccine (lot #659437/1266U). The last menstrual period was reported to be on 10-JAN-2008. An urine pregnancy test was performed with positive results. On 12-JAN-2008 a maternal serum alpha-fetoprotein test was performed within normal results. On 05-MAR-2008 an ultrasound was performed (NP). It was also reported that this is the patient's first pregnancy. The estimated delivery date is 16-OCT-2008. The certified nurse midwife reported she wishes to register the patient on the pregnancy registry. Follow-up information has been received from certified nurse midwife concerning the patient, who was also reported to be a smoker with no history of previous pregnancies. On 01-MAY-2008,  MSAFP screening test as performed and results were within normal limits. It was reported he mother developed oligohydramnios during the pregnancy. On 21-OCT-2008, 41.1 weeks from the last menstrual period, the patient delivered a normal male baby who weighted 7 pounds and 13.8 ounces. His length was 19 feet. His Apgar score was assessed to be 8/9. No complications occurred during the labor. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test positive, Premature labour, Ultrasound scan abnormal, Urinary tract infection
Clinical narrative: Initial and follow up information has been received from a certified nurse midwife for the Pregnancy Registry for GARDASIL, concerning a 22 year old white female with bipolar disorder and allergic reaction to KEFLEX and no previous pregnancies who on 03-OCT-2007 was vaccinated with a first dose of GARDASIL (lot # 658558/1061U).  On 04-DEC-2007 the patient was vaccinated with a second dose of GARDASIL vaccine (lot # 659437/1266U).  Concomitant therapy included SEROQUEL (lot # not reported) and ABILIFY for the treatment of bipolar disorder.  The patient's LMP was reported as 15-FEB-2008.  The patient's pregnancy was verified with an office pregnancy test during an office visit on 24-MAR-2008.  An ultrasound performed on 01-APR-2008 revealed a 6.4 week intrauterine pregnancy.  On an unspecified date in April 2008,  therapy with quetiapine fumarate and aripiprazole was discontinued.  The patient sought unspecified medical attention.  No problems were reported.  Follow up information has been received from a certified nurse midwife concerning a female patient concerning a female patient (Rh negative) who was vaccinated with a first and the second dose of GARDASIL on 03-OCT-2007 and 04-DEC-2007.  Concomitant therapy included WELLBUTRIN SR, SEROQUEL (reported) and ABILIFY.  The patient was treated for pre-term labor (2008) with TERBURALINE and was also treated for an urinary tract infection (2008) with MACROBID and AMOXICILLIN.  On 27-OCT-2008 (36 weeks from LMP) delivered a healthy female baby (7 lb 8 oz, 20 in length, head circumference 13.75 cm and APGAR score 8 at 1 minute/ 9 at 5 minutes).  The patient had not had a Group B strep test done so she was treated with AMPICILLIN 2 grams IV one time dose .  She also received a dose of RHOGAM.  Additional information is not expected.  (Rh negative)
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Anaemia, Chromosome analysis abnormal, Dehydration, Drug exposure during pregnancy, Platelet count decreased
Clinical narrative: Initial information and follow up has been received from a physician for the pregnancy registry for GARDASIL concerning a 24 year old female who on 21-May-2008, was vaccinated with her second dose of GARDASIL (lot# 659655/1486U) and found out on 27-May-2008 that she was pregnant. The patient's estimated LMP was 28-Apr-2008. Follow up information was received which reported that patient's concurrent medical condition included hypertension, and the patient smoked half a pack of cigarettes per day during pregnancy. Concomitant therapy included Tylenol and vitamins (unspecified). The  patient had ultrasounds (no results reported) and blood test positive for down's syndrome (however the baby was normal). During pregnancy she developed anemia, platelets decreased, vomiting and dehydration. On 27-Dec-2008, 35 weeks gestation, the patient gave birth to a female infant weighing 5 pounds and 5 ounces. The length was 19 inches. The infant was normal. There was no congenital anomaly. There were n complications during delivery. No further is available
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Premature labour, Vomiting
Clinical narrative: Initial information and follow up has been received from a physician for the pregnancy registry for GARDASIL concerning a 24 year old female who on 21-May-2008, was vaccinated with her second dose of GARDASIL (lot# 659655/1486U) and found out on 27-May-2008 that she was pregnant. The patient's estimated LMP was 28-Apr-2008. Follow up information was received which reported that patient's concurrent medical condition included hypertension, and the patient smoked half a pack of cigarettes per day during pregnancy. Concomitant therapy included Tylenol and vitamins (unspecified). The  patient had ultrasounds (no results reported) and blood test positive for down's syndrome (however the baby was normal). During pregnancy she developed anemia, platelets decreased, vomiting and dehydration. On 27-Dec-2008, 35 weeks gestation, the patient gave birth to a female infant weighing 5 pounds and 5 ounces. The length was 19 inches. The infant was normal. There was no congenital anomaly. There were n complications during delivery. No further is available
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Beta haemolytic streptococcal infection, Drug exposure during pregnancy, Ultrasound scan
Clinical narrative: Information has been received from a consumer and a nurse practitioner for the Pregnancy Registry for GARDASIL concerning herself, a 26 year old female with no medical history, and no drug reactions/allergies, who on 29-APR-2008 was vaccinated with her first dose of GARDASIL (lot # unspecified). On 02-May-2008 (three days later), the patient became pregnant (LMP estimated as 15-Apr-2008). Concomitant therapy included azithromycin (ZITHROMAX). The patient sought unspecified medical attention. At the time of this report the outcome was unknown. No further information available. Follow-up information received on 17-FEB-2009 from a nurse practitioner who reported the patient is Hispanic and has a history of smoking 2-5 cigarettes a day which she stopped with pregnancy, and an abnormal PAP s/p LEEP. Patient has had a previous pregnancy, no previous full term deliveries and a miscarriage. On 15-Jul-2008 patient had an ultrasound, which showed 12 weeks and 4 days pregnant ERA normal. On 13-AUG-2008 patient had a MSAFP testing with normal results. The lot # of the first dosage of GARDASIL received is 659180/1758U. Concomitant medications during pregnancy included prenatal vitamins (unspecified) which patient started taking on 18-JUN-08 (27 mg of Iron and folate 1mg daily) and on 08-JAN-2009 penicillin (unspecified) 3000000 international units every 4 hours for the treatment of bacterial infection due to streptococcus, group B. Date of last menstrual period on 18-APR-2008 (previously reported as 15-APR-2008) and estimated delivery date on 23-JAN-2009. Patient had a normal baby on 09-JAN-2009, male, who weighed 2975 grams, length 49 cm, Apgar score 9/9, head circumference 33.5 cm. No congenital anomalies or other complications or abnormalities. No complications during pregnancy, or during labor and/or delivery. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Inappropriate schedule of drug administration, Pregnancy test positive, Ultrasound scan normal
Clinical narrative: Information has been received through the pregnancy Registry for GARDASIL from a nurse concerning a 20 year old  female with no pertinent medical history and no history of drug reactions or allergies who on 04-Feb-2008 was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL. On 07-May-2008 the patient had her last menstrual period. On 29-May-2008 the patient was vaccinated intramuscularly with the second 0.5ml dose of GARDASIL (lot# 659964/1978U). Concomitant medication included doxycycline for the treatment of a chlamdia infection. On an unspecified date, a pregnancy test revealed the patient was pregnant. The patient had not experienced any known symptoms. On 07-Jul-2008, an ultrasound was performed, the results were within normal limits. The patient sought medical attention with a physician office visit. The patient was pregnant once previously, and it was a pre-term delivery. Follow up information has been received from a physician on 16-Feb-2009. It was reported that the 20 year old female patient was vaccinated on 14-Feb-2008 with the first dose of GARDASIL. The patient delivered a healthy baby on 06-Feb-2009. The pregnancy was normal except for induction for advance cervical dilation. On 16-Feb-2009, the patient was vaccinated with the third dose of GARDASIL. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Anaemia, Drug exposure during pregnancy, Inappropriate schedule of drug administration, Infection
Clinical narrative: Initial information has been received from an 18 year old female with no pertinent medical history or drug reactions or allergies, for the Pregnancy Registry for GARDASIL.  In November 2007, the patient was vaccinated with the first dose of GARDASIL.  In June 2008, the patient received "her second dose of GARDASIL while pregnant".  There was no concomitant medication.  The patient did not know she was pregnant at the time of vaccination.  As of 10-JUL-2008, the patient was one and a half months pregnant.  The patient did not seek medical attention.  Follow-up information was received from the physician which reported that the vaccine was not administered in her office.  The patient had no previous pregnancy and a history of papanicolaou smear abnormal.  The LMP of the patient was 23-MAY-2008.  The estimate delivery date was 27-FEB-2009.  ON 25-AUG-2008, ultrasound was performed for twin pregnancy and the results revealed normal twins.  ON 15-SEP-2008, maternal serum alpha-fetoprotein screening was performed and the results were normal.  Follow-up information has been received from a completed pregnancy questionnaire.  On approximately 03-SEP-2008, the patient developed infection.  On 03-SEP-2008, the patient was prescribed ROCEPHIN, 250 mg once and AZITHROMYCIN, 1 gram once for the treatment of infection.  The outcome of infection was not specified.  On approximately 01-DEC-2008, the patient developed anemia.  On 01-DEC-2008, the patient was prescribed REPLIVA, daily for the treatment of anemia.  The outcome of anemia was not specified.  On 22-JAN-2009, the patient delivered normal twins baby girls with no congenital anomalies at the 33.3 weeks gestation.  It was considered prematurity.  One of the baby weighed 3 pounds 14 ounces and another weighed 3 pounds 10 ounces.  The Apgar scores of both babies were 8/9.  It was reported that there was no complication during pregnancy and delivery.  Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Premature labour, Ultrasound scan
Clinical narrative: Initial information has been received from an 18 year old female with no pertinent medical history or drug reactions or allergies, for the Pregnancy Registry for GARDASIL.  In November 2007, the patient was vaccinated with the first dose of GARDASIL.  In June 2008, the patient received "her second dose of GARDASIL while pregnant".  There was no concomitant medication.  The patient did not know she was pregnant at the time of vaccination.  As of 10-JUL-2008, the patient was one and a half months pregnant.  The patient did not seek medical attention.  Follow-up information was received from the physician which reported that the vaccine was not administered in her office.  The patient had no previous pregnancy and a history of papanicolaou smear abnormal.  The LMP of the patient was 23-MAY-2008.  The estimate delivery date was 27-FEB-2009.  ON 25-AUG-2008, ultrasound was performed for twin pregnancy and the results revealed normal twins.  ON 15-SEP-2008, maternal serum alpha-fetoprotein screening was performed and the results were normal.  Follow-up information has been received from a completed pregnancy questionnaire.  On approximately 03-SEP-2008, the patient developed infection.  On 03-SEP-2008, the patient was prescribed ROCEPHIN, 250 mg once and AZITHROMYCIN, 1 gram once for the treatment of infection.  The outcome of infection was not specified.  On approximately 01-DEC-2008, the patient developed anemia.  On 01-DEC-2008, the patient was prescribed REPLIVA, daily for the treatment of anemia.  The outcome of anemia was not specified.  On 22-JAN-2009, the patient delivered normal twins baby girls with no congenital anomalies at the 33.3 weeks gestation.  It was considered prematurity.  One of the baby weighed 3 pounds 14 ounces and another weighed 3 pounds 10 ounces.  The Apgar scores of both babies were 8/9.  It was reported that there was no complication during pregnancy and delivery.  Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Beta haemolytic streptococcal infection, Blood test, Chlamydial infection, Drug exposure during pregnancy, Ultrasound scan
Clinical narrative: Initial and follow-up information has been received from a nurse, for the Pregnancy Registry for GARDASIL, concerning a 23 year old female smoker with a history of one pregnancy which the infant had gastroschisis and was pre-term premature rupture of fetal membranes at 32 weeks and pre-term delivery. On 19-MAY-2008 the patient was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot no. 659182/1757U) into the right deltoid. There was no concomitant medication. The patient is now pregnant. On 18-JUN-2008 the patient had ultrasound done for dating and the result was normal embryo. On an unspecified date the patient had routine blood and laboratory tests done and no results reported. No problems reported. The patient sought unspecified medical attention. Follow-up information has been received from a complete pregnancy questionnaire. The patient was taking prenatal vitamin, 1 tablet daily in the entire pregnancy. On approximately 15-SEP-2008 the patient developed bacterial vaginosis. On 15-SEP-2008, the patient was prescribed metronidazole, 500 mg, twice a day for 7 days for the treatment of bacterial vaginosis on 15-SEP-2008, the patient developed chlamydia. On 16-SEP-2008, the patient was prescribed ZITHROMAX, 1 gram once for the treatment of chlamydia. On an unspecified date, the patient developed Group B streptococcal infection. The outcome of the events was unknown. On 07-FEB-2009, the patient delivered a normal baby girl with no congenital anomalies for complications at the 40 weeks gestation. The baby weighted 7 pounds and 4 ounces. The length was 21 inches (53.3 cm). The Apgar score was 8/9 and the head circumference was 33.5 cm. It was reported that there was no complication during pregnancy and delivery. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Vaginitis bacterial
Clinical narrative: Initial and follow-up information has been received from a nurse, for the Pregnancy Registry for GARDASIL, concerning a 23 year old female smoker with a history of one pregnancy which the infant had gastroschisis and was pre-term premature rupture of fetal membranes at 32 weeks and pre-term delivery. On 19-MAY-2008 the patient was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot no. 659182/1757U) into the right deltoid. There was no concomitant medication. The patient is now pregnant. On 18-JUN-2008 the patient had ultrasound done for dating and the result was normal embryo. On an unspecified date the patient had routine blood and laboratory tests done and no results reported. No problems reported. The patient sought unspecified medical attention. Follow-up information has been received from a complete pregnancy questionnaire. The patient was taking prenatal vitamin, 1 tablet daily in the entire pregnancy. On approximately 15-SEP-2008 the patient developed bacterial vaginosis. On 15-SEP-2008, the patient was prescribed metronidazole, 500 mg, twice a day for 7 days for the treatment of bacterial vaginosis on 15-SEP-2008, the patient developed chlamydia. On 16-SEP-2008, the patient was prescribed ZITHROMAX, 1 gram once for the treatment of chlamydia. On an unspecified date, the patient developed Group B streptococcal infection. The outcome of the events was unknown. On 07-FEB-2009, the patient delivered a normal baby girl with no congenital anomalies for complications at the 40 weeks gestation. The baby weighted 7 pounds and 4 ounces. The length was 21 inches (53.3 cm). The Apgar score was 8/9 and the head circumference was 33.5 cm. It was reported that there was no complication during pregnancy and delivery. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Ultrasound scan abnormal
Clinical narrative: Information has been received from a licensed practical nurse through the pregnancy registry for GARDASIL concerning an 18 year old female with asthma and amoxicillin allergy who on 02-JUN-2008 was vaccinated with a first dose of GARDASIL (Lot # 659962/1740U) 0.5 ml intramuscularly. Concomitant therapy included prenatal vitamins. The nurse reported that the patient who received her first dose of GARDASIL is pregnant. No complications are reported. Medical attention was sought. On 19-JUN-2008, ultrasound revealed the patient had 10.1 weeks gestation at that time (gestation also reported as 5 weeks). Date of LMP was 09-APR-2008. Estimated date of delivery is 14-JAN-2009. There was no product quality complaint. Follow up information was received from a licensed practical nurse concerning an 18 year old female who on 02-JUN-2008 was vaccinated with a first dose of GARDASIL (Lot # 659962/1740U). Concomitant therapy included vitamins (unspecified). The LPN reported that on 19-JUN-2008 an ultrasound was performed which showed 10.1 weeks of gestation and confirm due date. On 22-AUG-2008 a routine ultrasound was performed: no problems were seen. The patient declined a Maternal Serum Alpha Fetoprotein Test. Date of LMP was 09-APR-2008. Estimated date of delivery is 14-JAN-2009. Follow up information was received from the pregnancy registry which reported that the patient delivered a normal healthy male baby on 15-JAN-2009. APGAR SCORE 8/9, weight: 8 pounds. The baby had no congenital anomalies, complications or abnormalities. The nurse reported fetal malpresentation and non reassuring fetal heart rate tracing during labor. It was also reported by the licensed practical nurse that the lot no. of first dose of GARDASIL was 661764/0650X (previously reported as Lot # 659962/1740U). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Hypoaesthesia, Injection site pain, Sensation of heaviness, Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning many patients that complain of pain after receiving GARDASIL. The nurse practitioner also reported that it "appears to be the most painful vaccination." Follow up information was received on 02-FEB-2009 from a nurse practitioner who stated that all the patients she has given GARDASIL too have complained that it was very painful, their arms went numb and felt heavy. The nurse practitioner felt this was why a lot of patients faint with the vaccine. The actual number of patients was not reported. This is one of several cases from the same source. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Muscle spasms, Pregnancy test negative, Ultrasound scan, Vomiting
Clinical narrative: Information has been received from a Licensed Practical Nurse (L.P.N.) for GARDASIL, a Pregnancy Registry product, concerning an 18 year old pregnant female smoker with no drug allergies who received her second dose of GARDASIL on 06-NOV-2006.  Date of initial dose was unspecified.  No details about the first or second dose of GARDASIL are known as another office administered them.  Concomitant therapy included LEXAPRO which was discontinued on 16-nov-2008.  An ultrasound showed patient was 5 weeks and 6 days pregnant at time of GARDASIL administration (LMP: 05-OCT-2008).  Follow-up information was received from the a physician concerning the 18 year old white female smoker with no previous pregnancies and a history of depression who on 06-NOV-2008 was vaccinated with a dose of GARDASIL though a clinic.  The patient had a LMP of 05-OCT-2008, became pregnant and had an EDD of 04-JUL-2009.  On 16-NOV-2008 ultrasound was done in the emergency room due to vomiting and cramping the ultrasound indicated 7 weeks gestation and on 21-JAN-2009 serum alpha-fetoprotein test negative.  The patient sought medical attention by visiting the physician's office.  Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Neuritis
Clinical narrative: Patient received the flu shot on 10/22/08.  Felt pain at the site.  A few days later pain continued at injection site.  Saw PCP.  Referred to specialist who diagnosed her 10 days later with neuritis.  Had physical therapy.
Sex: M
Vaccine: MNQ
Symptoms: Blood culture positive, Death, Meningitis meningococcal, Vaccination failure
Clinical narrative: Information was initially provided from the Centers for Disease Control (CDC) which concerned a total of 13 cases of MENACTRA vaccine failure from January 2005 to September 2008. No individual case information or patient identifiers were provided. This information was entered into case reference number 2008-04011. It was determined that five of these cases came from the VAERS database and had previously been entered in the Sanofi Pasteur Pharmacovigilance database (Sanofi Pasteur case reference numbers 2007-03425, 2007-03383, 2008-00038, 2008-00531, and 200802355). On 05 January 2009, additional information was provided for seven patients. This information included specific patient identifiers. The information for these cases is contained in cases 2009-00012, 2009-00013, 2009-00014, 2009-00015, 2009-00016, 2009-00017, and 2009-00018. This serious report was received from the Centers for Disease Control and Prevention (CDC) on 05 January 2009, under VAERS number 335762. A male patient, born in 1988 and with no reported medical history, received an injection of MENACTRA (lot number U2004AA) on 01 May 2006. The patient developed meningococcal disease on 03 June 2008. Culture confirmed meningococcal disease on 05 June 2008. Blood culture was positive for Neisseria meningitides serogroup C on 05 June 2008. The patient was hospitalized, and died on 08 June 2008. Documents held by sender: None.
Sex: M
Vaccine: MNQ
Symptoms: Blood culture positive, Death, Meningitis meningococcal, Vaccination failure
Clinical narrative: Information was initially provided from the Centers for Disease Control (CDC) which concerned a total of 13 cases of MENACTRA vaccine failure from January 2005 to September 2008. No individual case information or patient identifiers were provided. This information was entered into case reference number 2008-04011. It was determined that five of these cases came from the VAERS database and had previously been entered in the Sanofi Pasteur Pharmacovigilance database (Sanofi Pasteur case reference numbers 2007-03425, 2007-03383, 2008-00038, 2008-00531, and 200802355). On 05 January 2009, additional information was provided for seven patients. This information included specific patient identifiers. The information for these cases is contained in cases 2009-00012, 2009-00013, 2009-00014, 2009-00015, 2009-00016, 2009-00017, and 2009-00018. This serious report was received from the Centers for Disease Control and Prevention (CDC) on 05 January 2009, under VAERS number 335764. A male patient, born in 1988 and with no reported medical history, received an injection of MENACTRA (lot number U2236AA) on 25 June 2007. The route and site of administration for the MENACTRA vaccine was unknown. The patient developed meningococcal disease that was confirmed by culture on 26 September 2007. Blood culture on 26 September 2007 was positive for Neisseria meningitides serogroup C. The patient died on 27 September 2007. Documents held by sender: None.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Amnesia, Electroencephalogram, Fall, Grunting, Immediate post-injection reaction
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female with neurological disorder who on 03-MAR-2009 was vaccinated with a dose of GARDASIL vaccine in her left arm (LOT# 1432X, this lot is valid for another MSD product). Concomitant therapy included MENACTRA in her right arm (LOT# 62927AA). The onset of adverse event was immediate. The patient experienced as either convulsion, seizure or potential syncope episode. The patient passed out, leapt off the table and fell on floor, and hit her head on the floor. The patient has a history of neurological problems so they went immediately to a neurologist to do an EEG. The results were still outstanding at the time of the reporting. As far as long term effects there were none reported at the time of the report. The patient was still being monitored. The patient visited an urgent care facility because the mother felt the patient was still out of sorts. The outcome of adverse events was unknown. It was reported that the patient was still out of sorts. The outcome of adverse events were unknown. It was reported that the patient sought medical attention: visit an urgent care facility. Upon internal review convulsion, seizure was determined to be an other important medical event. Additional information has been requested
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Injury, Loss of consciousness, Muscle rigidity, Muscle tightness, Staring
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female with neurological disorder who on 03-MAR-2009 was vaccinated with a dose of GARDASIL vaccine in her left arm (LOT# 1432X, this lot is valid for another MSD product). Concomitant therapy included MENACTRA in her right arm (LOT# 62927AA). The onset of adverse event was immediate. The patient experienced as either convulsion, seizure or potential syncope episode. The patient passed out, leapt off the table and fell on floor, and hit her head on the floor. The patient has a history of neurological problems so they went immediately to a neurologist to do an EEG. The results were still outstanding at the time of the reporting. As far as long term effects there were none reported at the time of the report. The patient was still being monitored. The patient visited an urgent care facility because the mother felt the patient was still out of sorts. The outcome of adverse events was unknown. It was reported that the patient was still out of sorts. The outcome of adverse events were unknown. It was reported that the patient sought medical attention: visit an urgent care facility. Upon internal review convulsion, seizure was determined to be an other important medical event. Additional information has been requested
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Urinary incontinence
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female with neurological disorder who on 03-MAR-2009 was vaccinated with a dose of GARDASIL vaccine in her left arm (LOT# 1432X, this lot is valid for another MSD product). Concomitant therapy included MENACTRA in her right arm (LOT# 62927AA). The onset of adverse event was immediate. The patient experienced as either convulsion, seizure or potential syncope episode. The patient passed out, leapt off the table and fell on floor, and hit her head on the floor. The patient has a history of neurological problems so they went immediately to a neurologist to do an EEG. The results were still outstanding at the time of the reporting. As far as long term effects there were none reported at the time of the report. The patient was still being monitored. The patient visited an urgent care facility because the mother felt the patient was still out of sorts. The outcome of adverse events was unknown. It was reported that the patient was still out of sorts. The outcome of adverse events were unknown. It was reported that the patient sought medical attention: visit an urgent care facility. Upon internal review convulsion, seizure was determined to be an other important medical event. Additional information has been requested
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Convulsion, Electroencephalogram, Fall, Head injury, Immediate post-injection reaction
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female with neurological disorder who on 03-MAR-2009 was vaccinated with a dose of GARDASIL vaccine in her left arm (LOT# 1432X, this lot is valid for another MSD product). Concomitant therapy included MENACTRA in her right arm (LOT# 62927AA). The onset of adverse event was immediate. The patient experienced as either convulsion, seizure or potential syncope episode. The patient passed out, leapt off the table and fell on floor, and hit her head on the floor. The patient has a history of neurological problems so they went immediately to a neurologist to do an EEG. The results were still outstanding at the time of the reporting. As far as long term effects there were none reported at the time of the report. The patient was still being monitored. The patient visited an urgent care facility because the mother felt the patient was still out of sorts. The outcome of adverse events was unknown. It was reported that the patient was still out of sorts. The outcome of adverse events were unknown. It was reported that the patient sought medical attention: visit an urgent care facility. Upon internal review convulsion, seizure was determined to be an other important medical event. Additional information has been requested
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female with neurological disorder who on 03-MAR-2009 was vaccinated with a dose of GARDASIL vaccine in her left arm (LOT# 1432X, this lot is valid for another MSD product). Concomitant therapy included MENACTRA in her right arm (LOT# 62927AA). The onset of adverse event was immediate. The patient experienced as either convulsion, seizure or potential syncope episode. The patient passed out, leapt off the table and fell on floor, and hit her head on the floor. The patient has a history of neurological problems so they went immediately to a neurologist to do an EEG. The results were still outstanding at the time of the reporting. As far as long term effects there were none reported at the time of the report. The patient was still being monitored. The patient visited an urgent care facility because the mother felt the patient was still out of sorts. The outcome of adverse events was unknown. It was reported that the patient was still out of sorts. The outcome of adverse events were unknown. It was reported that the patient sought medical attention: visit an urgent care facility. Upon internal review convulsion, seizure was determined to be an other important medical event. Additional information has been requested
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Cyanosis, Dizziness, Immediate post-injection reaction, Migraine, Nausea
Clinical narrative: Fainted immediately after administrating vaccination. Severe migraine headaches - at least one episode everyday lasting at least 30 min. Headaches - non-stop for five days after the vaccination. Associated nausea also with the headaches. Some vomiting.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Syncope
Clinical narrative: Fainted immediately after administrating vaccination. Severe migraine headaches - at least one episode everyday lasting at least 30 min. Headaches - non-stop for five days after the vaccination. Associated nausea also with the headaches. Some vomiting.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Condition aggravated, Migraine, Nausea, Syncope, Vomiting
Clinical narrative: Fainted immediately after administrating vaccination. Severe migraine headaches - at least one episode everyday lasting at least 30 min. Headaches - non-stop for five days after the vaccination. Associated nausea also with the headaches. Some vomiting.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Headache, Migraine, Syncope, Urine human chorionic gonadotropin negative
Clinical narrative: Fainted immediately after administrating vaccination. Severe migraine headaches - at least one episode everyday lasting at least 30 min. Headaches - non-stop for five days after the vaccination. Associated nausea also with the headaches. Some vomiting.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Activities of daily living impaired, Dizziness, Ear discomfort, Feeling drunk, Hypersomnia
Clinical narrative: Pt received ZOSTAVAX on 1-10-09. Ears" plugged up" on Jan 11 2009. On Jan 14th, 2009 pt had episode at work with dizziness and emesis X 3. He reports on March 9, 2008 ears remain "plugged".
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Vomiting
Clinical narrative: Pt received ZOSTAVAX on 1-10-09. Ears" plugged up" on Jan 11 2009. On Jan 14th, 2009 pt had episode at work with dizziness and emesis X 3. He reports on March 9, 2008 ears remain "plugged".
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Ear discomfort, Vomiting
Clinical narrative: Pt received ZOSTAVAX on 1-10-09. Ears" plugged up" on Jan 11 2009. On Jan 14th, 2009 pt had episode at work with dizziness and emesis X 3. He reports on March 9, 2008 ears remain "plugged".
Age: 21.0
Sex: F
Vaccine: ANTH, SMALL, SMALL, TYP, ANTH, SMALL
Symptoms: Dyspnoea, Oral disorder, Pruritus, Pyrexia, Skin lesion
Clinical narrative: 7 DAYS AFTER RECEIVING SMALLPOX VACCINATION PATIENT PRESENTED WITH OPEN BLISTERS TO RIGHT HAND AND THE INSIDE OF MOUTH. PATIENT WAS REFERRED ON TO MEDICAL CLINIC WHERE SHE WAS PLACED ON CONTACT PRECAUTIONS. 3/20/09 MR received. One week s/p smallpox vax pt inadvertently scratched inoculation site and then ate finger food.  Developed papular lesions on index finger and in pharynx.  Also c/o extreme fatigue and myalgias, sore throat. Assessment:  Auto-innoculation by scratch, then spread on R index finger and posterior pharynx.  Myalgia and myositis. Tx: pain meds
Age: 21.0
Sex: F
Vaccine: ANTH, SMALL, SMALL, TYP, ANTH, SMALL
Symptoms: Blister, Oropharyngeal blistering
Clinical narrative: 7 DAYS AFTER RECEIVING SMALLPOX VACCINATION PATIENT PRESENTED WITH OPEN BLISTERS TO RIGHT HAND AND THE INSIDE OF MOUTH. PATIENT WAS REFERRED ON TO MEDICAL CLINIC WHERE SHE WAS PLACED ON CONTACT PRECAUTIONS. 3/20/09 MR received. One week s/p smallpox vax pt inadvertently scratched inoculation site and then ate finger food.  Developed papular lesions on index finger and in pharynx.  Also c/o extreme fatigue and myalgias, sore throat. Assessment:  Auto-innoculation by scratch, then spread on R index finger and posterior pharynx.  Myalgia and myositis. Tx: pain meds
Age: 21.0
Sex: F
Vaccine: ANTH, SMALL, SMALL, TYP, ANTH, SMALL
Symptoms: Dyspnoea, Fatigue, Myalgia, Myositis, Oropharyngeal pain
Clinical narrative: 7 DAYS AFTER RECEIVING SMALLPOX VACCINATION PATIENT PRESENTED WITH OPEN BLISTERS TO RIGHT HAND AND THE INSIDE OF MOUTH. PATIENT WAS REFERRED ON TO MEDICAL CLINIC WHERE SHE WAS PLACED ON CONTACT PRECAUTIONS. 3/20/09 MR received. One week s/p smallpox vax pt inadvertently scratched inoculation site and then ate finger food.  Developed papular lesions on index finger and in pharynx.  Also c/o extreme fatigue and myalgias, sore throat. Assessment:  Auto-innoculation by scratch, then spread on R index finger and posterior pharynx.  Myalgia and myositis. Tx: pain meds
Age: 21.0
Sex: F
Vaccine: ANTH, SMALL, SMALL, TYP, ANTH, SMALL
Symptoms: Post vaccination autoinoculation, Pruritus, Pyrexia, Skin lesion, Stomatitis
Clinical narrative: 7 DAYS AFTER RECEIVING SMALLPOX VACCINATION PATIENT PRESENTED WITH OPEN BLISTERS TO RIGHT HAND AND THE INSIDE OF MOUTH. PATIENT WAS REFERRED ON TO MEDICAL CLINIC WHERE SHE WAS PLACED ON CONTACT PRECAUTIONS. 3/20/09 MR received. One week s/p smallpox vax pt inadvertently scratched inoculation site and then ate finger food.  Developed papular lesions on index finger and in pharynx.  Also c/o extreme fatigue and myalgias, sore throat. Assessment:  Auto-innoculation by scratch, then spread on R index finger and posterior pharynx.  Myalgia and myositis. Tx: pain meds
Age: 26.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Body temperature increased, Full blood count, Rash generalised, Red blood cell sedimentation rate, Respiratory distress
Clinical narrative: 3-10-09, 5:30PM CALLED FAMILY MD WITH C/O'S OF SHORTNESS OF BREATH, TEMPERATURE, WHEEZING, HIVES AND SHAKES, MD TOLD PATIENT TO TAKE BENADRYL, BUT SYMPTOMS INCREASED AND SHE WENT TO THE EMERGENCY ROOM.  9:00PM WENT TO ER, GIVEN EPI, BENADRYL, PREDNISONE AND ATIVAN.  SYMPTOMS THE SAME PLUS HEART RATE=168, 02 SATURATION IN HIGH 80'S, SWELLING IN THROAT AND TROUBLE WITH SWALLOWING. AFTER SYMPTOMS DECREASED, PATIENT WAS SENT HOME.  ON 3/11/09, 4:00PM RETURNED TO ER WITH SAME SYMPTOMS, RECEIVED SAME TREATMENT AND WAS RELEASED AROUND 6:00PM. AT 11:00PM ON 3/11/09, WENT BACK TO THE ER WITH SAME SYMPTOMS EXCEPT INCREASING SHORTNESS OF BREATH, 02 SATS ONLY HIGH 80'S.  STAYED IN ER ALL NIGHT AND WAS TO LEAVE IN AM, BUT SYMPTOMS INCREASED AND PATIENT WAS ADMITTED.  FRIDAY, 3/13/09 SYMPTOMS INCREASED AND PATIENT WAS ADMITTED TO HOSPITAL.  PT WAS RELEASED FROM HOSPITAL ON 3/16/09 AND WAS INFORMED SHE HAD "SICK SINUS SYNDROME" THOUGHT DUE TO ANAPHYLACTIC REACTION FROM VACCINES GIVEN ON 3/10/09. 3/17/09 PATIENT STILL COMPLAINING OF SHORTNESS OF BREATH, FOLLOWING UP WITH MD FOR THIS COMPLAINT.
Age: 26.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Tachycardia
Clinical narrative: 3-10-09, 5:30PM CALLED FAMILY MD WITH C/O'S OF SHORTNESS OF BREATH, TEMPERATURE, WHEEZING, HIVES AND SHAKES, MD TOLD PATIENT TO TAKE BENADRYL, BUT SYMPTOMS INCREASED AND SHE WENT TO THE EMERGENCY ROOM.  9:00PM WENT TO ER, GIVEN EPI, BENADRYL, PREDNISONE AND ATIVAN.  SYMPTOMS THE SAME PLUS HEART RATE=168, 02 SATURATION IN HIGH 80'S, SWELLING IN THROAT AND TROUBLE WITH SWALLOWING. AFTER SYMPTOMS DECREASED, PATIENT WAS SENT HOME.  ON 3/11/09, 4:00PM RETURNED TO ER WITH SAME SYMPTOMS, RECEIVED SAME TREATMENT AND WAS RELEASED AROUND 6:00PM. AT 11:00PM ON 3/11/09, WENT BACK TO THE ER WITH SAME SYMPTOMS EXCEPT INCREASING SHORTNESS OF BREATH, 02 SATS ONLY HIGH 80'S.  STAYED IN ER ALL NIGHT AND WAS TO LEAVE IN AM, BUT SYMPTOMS INCREASED AND PATIENT WAS ADMITTED.  FRIDAY, 3/13/09 SYMPTOMS INCREASED AND PATIENT WAS ADMITTED TO HOSPITAL.  PT WAS RELEASED FROM HOSPITAL ON 3/16/09 AND WAS INFORMED SHE HAD "SICK SINUS SYNDROME" THOUGHT DUE TO ANAPHYLACTIC REACTION FROM VACCINES GIVEN ON 3/10/09. 3/17/09 PATIENT STILL COMPLAINING OF SHORTNESS OF BREATH, FOLLOWING UP WITH MD FOR THIS COMPLAINT.
Age: 26.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Anaphylactic reaction, Body temperature increased, Dysphagia, Dyspnoea, Oxygen saturation decreased
Clinical narrative: 3-10-09, 5:30PM CALLED FAMILY MD WITH C/O'S OF SHORTNESS OF BREATH, TEMPERATURE, WHEEZING, HIVES AND SHAKES, MD TOLD PATIENT TO TAKE BENADRYL, BUT SYMPTOMS INCREASED AND SHE WENT TO THE EMERGENCY ROOM.  9:00PM WENT TO ER, GIVEN EPI, BENADRYL, PREDNISONE AND ATIVAN.  SYMPTOMS THE SAME PLUS HEART RATE=168, 02 SATURATION IN HIGH 80'S, SWELLING IN THROAT AND TROUBLE WITH SWALLOWING. AFTER SYMPTOMS DECREASED, PATIENT WAS SENT HOME.  ON 3/11/09, 4:00PM RETURNED TO ER WITH SAME SYMPTOMS, RECEIVED SAME TREATMENT AND WAS RELEASED AROUND 6:00PM. AT 11:00PM ON 3/11/09, WENT BACK TO THE ER WITH SAME SYMPTOMS EXCEPT INCREASING SHORTNESS OF BREATH, 02 SATS ONLY HIGH 80'S.  STAYED IN ER ALL NIGHT AND WAS TO LEAVE IN AM, BUT SYMPTOMS INCREASED AND PATIENT WAS ADMITTED.  FRIDAY, 3/13/09 SYMPTOMS INCREASED AND PATIENT WAS ADMITTED TO HOSPITAL.  PT WAS RELEASED FROM HOSPITAL ON 3/16/09 AND WAS INFORMED SHE HAD "SICK SINUS SYNDROME" THOUGHT DUE TO ANAPHYLACTIC REACTION FROM VACCINES GIVEN ON 3/10/09. 3/17/09 PATIENT STILL COMPLAINING OF SHORTNESS OF BREATH, FOLLOWING UP WITH MD FOR THIS COMPLAINT.
Age: 26.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pharyngeal oedema, Sick sinus syndrome, Tremor, Urticaria, Wheezing
Clinical narrative: 3-10-09, 5:30PM CALLED FAMILY MD WITH C/O'S OF SHORTNESS OF BREATH, TEMPERATURE, WHEEZING, HIVES AND SHAKES, MD TOLD PATIENT TO TAKE BENADRYL, BUT SYMPTOMS INCREASED AND SHE WENT TO THE EMERGENCY ROOM.  9:00PM WENT TO ER, GIVEN EPI, BENADRYL, PREDNISONE AND ATIVAN.  SYMPTOMS THE SAME PLUS HEART RATE=168, 02 SATURATION IN HIGH 80'S, SWELLING IN THROAT AND TROUBLE WITH SWALLOWING. AFTER SYMPTOMS DECREASED, PATIENT WAS SENT HOME.  ON 3/11/09, 4:00PM RETURNED TO ER WITH SAME SYMPTOMS, RECEIVED SAME TREATMENT AND WAS RELEASED AROUND 6:00PM. AT 11:00PM ON 3/11/09, WENT BACK TO THE ER WITH SAME SYMPTOMS EXCEPT INCREASING SHORTNESS OF BREATH, 02 SATS ONLY HIGH 80'S.  STAYED IN ER ALL NIGHT AND WAS TO LEAVE IN AM, BUT SYMPTOMS INCREASED AND PATIENT WAS ADMITTED.  FRIDAY, 3/13/09 SYMPTOMS INCREASED AND PATIENT WAS ADMITTED TO HOSPITAL.  PT WAS RELEASED FROM HOSPITAL ON 3/16/09 AND WAS INFORMED SHE HAD "SICK SINUS SYNDROME" THOUGHT DUE TO ANAPHYLACTIC REACTION FROM VACCINES GIVEN ON 3/10/09. 3/17/09 PATIENT STILL COMPLAINING OF SHORTNESS OF BREATH, FOLLOWING UP WITH MD FOR THIS COMPLAINT.
Age: 0.25
Sex: F
Vaccine: DTAPIPVHIB, RVX
Symptoms: Decreased appetite, Diet refusal, Fontanelle bulging, Hypersomnia, Injection site erythema
Clinical narrative: redness, swelling, heat and hard spot at site of injection 24-72 hours after initial injection. Low grade fever of approximately 100 degrees farenheit 48-96 hours after injection. Fussiness 12-96 hours after injection. Inconsolable screaming for 1.5 to 3 hours after 72 hours and continuing daily until day 7. Suspected bulging fontanel from 48-72 hours after injection. Vomiting 72-96 hours after injection. Decreased appetite and refusal to nurse 48-72 hours after injection. Increased sleepiness (12 hours at a time) 72 hours to 96 hours after injection.
Age: 0.25
Sex: F
Vaccine: DTAPIPVHIB, RVX
Symptoms: Injection site induration, Injection site swelling, Injection site warmth, Irritability, Pyrexia
Clinical narrative: redness, swelling, heat and hard spot at site of injection 24-72 hours after initial injection. Low grade fever of approximately 100 degrees farenheit 48-96 hours after injection. Fussiness 12-96 hours after injection. Inconsolable screaming for 1.5 to 3 hours after 72 hours and continuing daily until day 7. Suspected bulging fontanel from 48-72 hours after injection. Vomiting 72-96 hours after injection. Decreased appetite and refusal to nurse 48-72 hours after injection. Increased sleepiness (12 hours at a time) 72 hours to 96 hours after injection.
Age: 0.25
Sex: F
Vaccine: DTAPIPVHIB, RVX
Symptoms: Screaming, Vomiting
Clinical narrative: redness, swelling, heat and hard spot at site of injection 24-72 hours after initial injection. Low grade fever of approximately 100 degrees farenheit 48-96 hours after injection. Fussiness 12-96 hours after injection. Inconsolable screaming for 1.5 to 3 hours after 72 hours and continuing daily until day 7. Suspected bulging fontanel from 48-72 hours after injection. Vomiting 72-96 hours after injection. Decreased appetite and refusal to nurse 48-72 hours after injection. Increased sleepiness (12 hours at a time) 72 hours to 96 hours after injection.
Sex: U
Vaccine: MEA
Symptoms: Death, Measles
Clinical narrative: Information has been received from a published article, concerning "a patient who was vaccinated with two doses of ATTENUVAX (manufacturer unknown). In approximately 2004, the patient experienced measles related death. The cause of death was measles." The article also discussed the experience of 1 other patient who died while on therapy with ATTENUVAX (manufacturer unknown) (WAES# 0903USA01794). Additional information has been requested. A copy of the published article is attached as further documentation of the patient's experience.
Sex: U
Vaccine: MEA
Symptoms: Death, Measles
Clinical narrative: Information has been received from a published article, concerning "a patient who was vaccinated with one dose of ATTENUVAX (manufacturer unknown). In approximately 2004, the patient experienced measles related death. The cause of death was measles." The article also discussed the experience of 1 other patient who died while on therapy with ATTENUVAX (manufacturer unknown) (WAES# 0903USA02000). Additional information has been requested. A copy of the published article is attached as further documentation of the patient's experience.
Age: 0.2
Sex: U
Vaccine: HIBV
Symptoms: Death, Haemophilus infection
Clinical narrative: Information has been received form a physician who received a "health alert" from the health department concerning an 8 week old patient who was vaccinated with unspecified HIB (manufacturer unknown) (Lot# not reported). 5-6 days after receiving the unspecified HIB (manufacturer unknown), the patient developed invasive HIB disease and died shortly afterward. The adverse events were considered to be immediately life-threatening. It was not reported whether the patient's sought medical attention. This is one of several reports receive from the same resource. Additional information has been requested.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Anti-cyclic citrullinated peptide antibody, Arthralgia, Injected limb mobility decreased, Joint range of motion decreased, Pain
Clinical narrative: Information has been received from a 91 year old female patient with an unspecified thyroid disorder, recent diagnosis of hypertension, nitroglycerin allergy and possible Sulfonamide allergy and with a history of glaucoma; who on 26-MAR-2008 was vaccinated with ZOSTAVAX (Lot # 659403/1825U), subcutaneously in the left arm. Concomitant therapy included an unspecified thyroid medication, Lovastatin (manufacturer unknown) and Lisinopril (manufacturer unknown). The consumer reported that on approximately 26-APR-2008, one month after receiving ZOSTAVAX, she developed rheumatoid arthritis. The patient started having pain and difficulty moving her left arm one month after receiving the vaccine. The pain and swelling progressed to her right hand, fingers and knees. The patient's physician prescribed Methotrexate. The patient stated that she was hospitalized on 22-JAN-2009 because the Methotrexate caused to have respiratory problems. Methotrexate was discontinued. On unspecified dates rheumatoid factor, antinuclear antibody and Lyme disease titer tests were performed with unreported results. Multiple blood test performed on unreported dates included sedimentation rate of 34 and cyclic citrullinated peptide antibody of 250. At the time of the report, the patient had not recovered. The patient sought medical attention and visited physician's office. Additional information has been requested.