chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL
Symptoms: Immediate post-injection reaction, Pallor, Syncope
Clinical narrative: Information has been received from an office manager concerning a 13 year old female with no pertinent medical history or drug reactions or allergies who on 12-MAY-2009 was vaccinated with the first 0.5 ml dose of GARDASIL (lot # 661953/1130X) in the left arm. Concomitant suspect therapy included a dose of VARIVAX (lot # 659455/0228Y) administered in the right arm. Other concomitant therapy included (MENACTRA) and (HAVRIX). On 12-MAY-2009, "after receiving all of these vaccinations", the patient became pale and fainted. The patient was still at the physician's office when the symptoms occurred and began to recover within ten minutes. At the time of this report, the patient's final outcome was not specified. No lab tests were done. The patient was seen at the office and sought unspecified medical attention. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL
Symptoms: Fall, Pallor, Syncope, Tremor
Clinical narrative: This report was received from GlaxoSmithKline and was assigned manufacturer report number A0784405A for (HAVRIX). On 12-MAy-2009, a 13 year old female was vaccinated with the first dose of GARDASIL (lot # 661953/1130X). Concomitant suspect vaccination included the second dose of VARIVAX (lot # 659455/0228Y0 given on the same day. Other concomitant vaccinations included the first dose of (HAVRIX) (lot # AHAV33341A) given at 15:30 in the left arm and the first dose of (MENACTRA) (lot # M2870AA) given on the same day. On 12-MAY-2009 at 16:22, 52 minutes after vaccination, the patient experienced fainting, became pale, shaky and fell. The patient required emergency room and/or doctor visit. She had to suit for 10 minutes with her head between her legs and was given an energy bar and an unspecified drink. At the time of the report, the patient recovered from the events. This was originally reported by a healthcare professional. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL
Symptoms: Loss of consciousness, Syncope
Clinical narrative: This report was received from GlaxoSmithKline and was assigned manufacturer report number A0784405A for (HAVRIX). On 12-MAy-2009, a 13 year old female was vaccinated with the first dose of GARDASIL (lot # 661953/1130X). Concomitant suspect vaccination included the second dose of VARIVAX (lot # 659455/0228Y0 given on the same day. Other concomitant vaccinations included the first dose of (HAVRIX) (lot # AHAV33341A) given at 15:30 in the left arm and the first dose of (MENACTRA) (lot # M2870AA) given on the same day. On 12-MAY-2009 at 16:22, 52 minutes after vaccination, the patient experienced fainting, became pale, shaky and fell. The patient required emergency room and/or doctor visit. She had to suit for 10 minutes with her head between her legs and was given an energy bar and an unspecified drink. At the time of the report, the patient recovered from the events. This was originally reported by a healthcare professional. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL
Symptoms: Immediate post-injection reaction, Pallor, Syncope
Clinical narrative: This report was received from GlaxoSmithKline and was assigned manufacturer report number A0784405A for (HAVRIX). On 12-MAy-2009, a 13 year old female was vaccinated with the first dose of GARDASIL (lot # 661953/1130X). Concomitant suspect vaccination included the second dose of VARIVAX (lot # 659455/0228Y0 given on the same day. Other concomitant vaccinations included the first dose of (HAVRIX) (lot # AHAV33341A) given at 15:30 in the left arm and the first dose of (MENACTRA) (lot # M2870AA) given on the same day. On 12-MAY-2009 at 16:22, 52 minutes after vaccination, the patient experienced fainting, became pale, shaky and fell. The patient required emergency room and/or doctor visit. She had to suit for 10 minutes with her head between her legs and was given an energy bar and an unspecified drink. At the time of the report, the patient recovered from the events. This was originally reported by a healthcare professional. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anaemia of pregnancy, Caesarean section, Complication of pregnancy, Drug exposure during pregnancy, Foetal growth retardation
Clinical narrative: Information has been received from a registered nurse and a staff member in a office, for the pregnancy registry for GARDASIL, concerning a 24 year old female with renal disease - glomerulonephritis, post partum anemia and history of 5 previous pregnancies, 4 live births, 1 spontaneous abortion who on 20-Sep-2006 was vaccinated with the first dose of GARDASIL (lot# 653735/0688F). On 05-Apr-2007 the patient delivered a normal, healthy male baby (WAES# 0707USA01442). On 20-Nov-2006, the patient was vaccinated with dose of FLUVIREIN (lot# 7135). On 13-Jul-2007 the patient was vaccinated with the second dose of GARDASIL (lot# 657868/0523U). The patient was pregnant, patient's date of last menstrual period was 04-Feb-2008, estimated delivery date 10-Nov-2008. Medication used during pregnancy included prenatal vitamin, iron. On 13-May-2008 24 hour urine cr / cl (creatinine clearance) was performed due to history of renal disease with result WNL. On 05-Sep-2008 ultrasound was performed due to history of renal disease with result within normal limit (WNL). On 11-Sep-2008 non stress test (NST) was performed with result reactive/reassessing. Patient declined MSAFP testing. On 04-Nov-2008, the patient was admitted to the hospital for a repeat C-section and delivered a normal, healthy female baby weighing 7 pounds 11 ounces at 39 week and 1 day pregnancy. The agars score test was preformed with result 9/9. The patient was diagnosed with uterine atony after the delivery of the baby on 04-Nov-2008 and was treated with METHERGINE injection. The patient was also diagnosed with post partum anemia from which she recovered (not considered to be life threatening; no date provided, she had this with a previous pregnancy as well) the patient was discharged from the hospital on 07-Nov-2008 and therefore did not require prolonged hospitalization for any reason. On 20-Nov-2008 the patient was vaccinated with the third dose of GARDASIL (lot# 661531/1311X) No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anaemia of pregnancy, Drug exposure during pregnancy, Inappropriate schedule of drug administration, Ultrasound scan, Uterine atony
Clinical narrative: Information has been received from a registered nurse and a staff member in a office, for the pregnancy registry for GARDASIL, concerning a 24 year old female with renal disease - glomerulonephritis, post partum anemia and history of 5 previous pregnancies, 4 live births, 1 spontaneous abortion who on 20-Sep-2006 was vaccinated with the first dose of GARDASIL (lot# 653735/0688F). On 05-Apr-2007 the patient delivered a normal, healthy male baby (WAES# 0707USA01442). On 20-Nov-2006, the patient was vaccinated with dose of FLUVIREIN (lot# 7135). On 13-Jul-2007 the patient was vaccinated with the second dose of GARDASIL (lot# 657868/0523U). The patient was pregnant, patient's date of last menstrual period was 04-Feb-2008, estimated delivery date 10-Nov-2008. Medication used during pregnancy included prenatal vitamin, iron. On 13-May-2008 24 hour urine cr / cl (creatinine clearance) was performed due to history of renal disease with result WNL. On 05-Sep-2008 ultrasound was performed due to history of renal disease with result within normal limit (WNL). On 11-Sep-2008 non stress test (NST) was performed with result reactive/reassessing. Patient declined MSAFP testing. On 04-Nov-2008, the patient was admitted to the hospital for a repeat C-section and delivered a normal, healthy female baby weighing 7 pounds 11 ounces at 39 week and 1 day pregnancy. The agars score test was preformed with result 9/9. The patient was diagnosed with uterine atony after the delivery of the baby on 04-Nov-2008 and was treated with METHERGINE injection. The patient was also diagnosed with post partum anemia from which she recovered (not considered to be life threatening; no date provided, she had this with a previous pregnancy as well) the patient was discharged from the hospital on 07-Nov-2008 and therefore did not require prolonged hospitalization for any reason. On 20-Nov-2008 the patient was vaccinated with the third dose of GARDASIL (lot# 661531/1311X) No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MEN, TD, HPV4, MNQ, TDAP
Symptoms: Arthralgia, Blood creatine phosphokinase normal, Chest discomfort, Feeling hot, Full blood count normal
Clinical narrative: Information has been received from a consumer concerning his daughter, a 13 year old female who was allergic to pineapple and CEPHALOSPORIN and with a mild asthma, received the first dose of GARDASIL on 05-MAY-2009.  Concomitant therapy included FLOVENT.  On 06-MAY-2009, the patient experienced severe pain in both arms, legs, chest, and abdomen.  Her skin could not be touched because she was in so much pain.  She was taken to the Emergency Room where she was given pain medication and tests were done for 5 hours.  All tests came back negative.  About 3-4 days the pain seemed to have gone away.   On 20-MAY-2009, the severe pain came back.  The patient would not be receiving her second or third dose of GARDASIL.  No lot number was provided.  At the time of reporting, the patient's severe pain persisted.  Follow- up information has been received from a medical assistant who stated that the lot # of GARDASIL was 661952/1129X.  The patient received the following vaccines concomitantly on 05-MAY-2009:  MENACTRA, (lot # U2875AA) and BOOSTRIX, (Lot # AC52B030AA).  On 06-MAY-2009 the patient went to a hospital and complained of shaking, chills, cough and dark colored urine.  The patient was treated with IV fluids, DILAUDID and ZOFRAN.  The patient had a urine analysis test and a CBC blood test (results not reported).  The patient was not admitted to the hospital.  On 07-MAY-2009 the physician evaluated the patient.  The patient did not received any treatment at the time.  On 22-MAY-2009, the patient was seen by the physician's assistant.  The patient stated that she was improving but had body aches, nausea, and had a warm feeling with no associated fever.  The patient had a CBC, Complete Metabolic Panel (CMP) and CK blood tests.  The patient's CK was slightly lower than normal (other results not reported).  The patient was not treated at the time.  The patient was referred to a neurologist.  Additional information has been requested.  The patient was seen at hospital.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MEN, TD, HPV4, MNQ, TDAP
Symptoms: Influenza serology negative, Myalgia, Urine analysis normal
Clinical narrative: Information has been received from a consumer concerning his daughter, a 13 year old female who was allergic to pineapple and CEPHALOSPORIN and with a mild asthma, received the first dose of GARDASIL on 05-MAY-2009.  Concomitant therapy included FLOVENT.  On 06-MAY-2009, the patient experienced severe pain in both arms, legs, chest, and abdomen.  Her skin could not be touched because she was in so much pain.  She was taken to the Emergency Room where she was given pain medication and tests were done for 5 hours.  All tests came back negative.  About 3-4 days the pain seemed to have gone away.   On 20-MAY-2009, the severe pain came back.  The patient would not be receiving her second or third dose of GARDASIL.  No lot number was provided.  At the time of reporting, the patient's severe pain persisted.  Follow- up information has been received from a medical assistant who stated that the lot # of GARDASIL was 661952/1129X.  The patient received the following vaccines concomitantly on 05-MAY-2009:  MENACTRA, (lot # U2875AA) and BOOSTRIX, (Lot # AC52B030AA).  On 06-MAY-2009 the patient went to a hospital and complained of shaking, chills, cough and dark colored urine.  The patient was treated with IV fluids, DILAUDID and ZOFRAN.  The patient had a urine analysis test and a CBC blood test (results not reported).  The patient was not admitted to the hospital.  On 07-MAY-2009 the physician evaluated the patient.  The patient did not received any treatment at the time.  On 22-MAY-2009, the patient was seen by the physician's assistant.  The patient stated that she was improving but had body aches, nausea, and had a warm feeling with no associated fever.  The patient had a CBC, Complete Metabolic Panel (CMP) and CK blood tests.  The patient's CK was slightly lower than normal (other results not reported).  The patient was not treated at the time.  The patient was referred to a neurologist.  Additional information has been requested.  The patient was seen at hospital.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MEN, TD, HPV4, MNQ, TDAP
Symptoms: Abdominal pain, Chest pain, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a consumer concerning his daughter, a 13 year old female who was allergic to pineapple and CEPHALOSPORIN and with a mild asthma, received the first dose of GARDASIL on 05-MAY-2009.  Concomitant therapy included FLOVENT.  On 06-MAY-2009, the patient experienced severe pain in both arms, legs, chest, and abdomen.  Her skin could not be touched because she was in so much pain.  She was taken to the Emergency Room where she was given pain medication and tests were done for 5 hours.  All tests came back negative.  About 3-4 days the pain seemed to have gone away.   On 20-MAY-2009, the severe pain came back.  The patient would not be receiving her second or third dose of GARDASIL.  No lot number was provided.  At the time of reporting, the patient's severe pain persisted.  Follow- up information has been received from a medical assistant who stated that the lot # of GARDASIL was 661952/1129X.  The patient received the following vaccines concomitantly on 05-MAY-2009:  MENACTRA, (lot # U2875AA) and BOOSTRIX, (Lot # AC52B030AA).  On 06-MAY-2009 the patient went to a hospital and complained of shaking, chills, cough and dark colored urine.  The patient was treated with IV fluids, DILAUDID and ZOFRAN.  The patient had a urine analysis test and a CBC blood test (results not reported).  The patient was not admitted to the hospital.  On 07-MAY-2009 the physician evaluated the patient.  The patient did not received any treatment at the time.  On 22-MAY-2009, the patient was seen by the physician's assistant.  The patient stated that she was improving but had body aches, nausea, and had a warm feeling with no associated fever.  The patient had a CBC, Complete Metabolic Panel (CMP) and CK blood tests.  The patient's CK was slightly lower than normal (other results not reported).  The patient was not treated at the time.  The patient was referred to a neurologist.  Additional information has been requested.  The patient was seen at hospital.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MEN, TD, HPV4, MNQ, TDAP
Symptoms: Urine analysis normal
Clinical narrative: Information has been received from a consumer concerning his daughter, a 13 year old female who was allergic to pineapple and CEPHALOSPORIN and with a mild asthma, received the first dose of GARDASIL on 05-MAY-2009.  Concomitant therapy included FLOVENT.  On 06-MAY-2009, the patient experienced severe pain in both arms, legs, chest, and abdomen.  Her skin could not be touched because she was in so much pain.  She was taken to the Emergency Room where she was given pain medication and tests were done for 5 hours.  All tests came back negative.  About 3-4 days the pain seemed to have gone away.   On 20-MAY-2009, the severe pain came back.  The patient would not be receiving her second or third dose of GARDASIL.  No lot number was provided.  At the time of reporting, the patient's severe pain persisted.  Follow- up information has been received from a medical assistant who stated that the lot # of GARDASIL was 661952/1129X.  The patient received the following vaccines concomitantly on 05-MAY-2009:  MENACTRA, (lot # U2875AA) and BOOSTRIX, (Lot # AC52B030AA).  On 06-MAY-2009 the patient went to a hospital and complained of shaking, chills, cough and dark colored urine.  The patient was treated with IV fluids, DILAUDID and ZOFRAN.  The patient had a urine analysis test and a CBC blood test (results not reported).  The patient was not admitted to the hospital.  On 07-MAY-2009 the physician evaluated the patient.  The patient did not received any treatment at the time.  On 22-MAY-2009, the patient was seen by the physician's assistant.  The patient stated that she was improving but had body aches, nausea, and had a warm feeling with no associated fever.  The patient had a CBC, Complete Metabolic Panel (CMP) and CK blood tests.  The patient's CK was slightly lower than normal (other results not reported).  The patient was not treated at the time.  The patient was referred to a neurologist.  Additional information has been requested.  The patient was seen at hospital.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MEN, TD, HPV4, MNQ, TDAP
Symptoms: Abdominal pain, Blood creatine phosphokinase abnormal, Chest pain, Chills, Chromaturia
Clinical narrative: Information has been received from a consumer concerning his daughter, a 13 year old female who was allergic to pineapple and CEPHALOSPORIN and with a mild asthma, received the first dose of GARDASIL on 05-MAY-2009.  Concomitant therapy included FLOVENT.  On 06-MAY-2009, the patient experienced severe pain in both arms, legs, chest, and abdomen.  Her skin could not be touched because she was in so much pain.  She was taken to the Emergency Room where she was given pain medication and tests were done for 5 hours.  All tests came back negative.  About 3-4 days the pain seemed to have gone away.   On 20-MAY-2009, the severe pain came back.  The patient would not be receiving her second or third dose of GARDASIL.  No lot number was provided.  At the time of reporting, the patient's severe pain persisted.  Follow- up information has been received from a medical assistant who stated that the lot # of GARDASIL was 661952/1129X.  The patient received the following vaccines concomitantly on 05-MAY-2009:  MENACTRA, (lot # U2875AA) and BOOSTRIX, (Lot # AC52B030AA).  On 06-MAY-2009 the patient went to a hospital and complained of shaking, chills, cough and dark colored urine.  The patient was treated with IV fluids, DILAUDID and ZOFRAN.  The patient had a urine analysis test and a CBC blood test (results not reported).  The patient was not admitted to the hospital.  On 07-MAY-2009 the physician evaluated the patient.  The patient did not received any treatment at the time.  On 22-MAY-2009, the patient was seen by the physician's assistant.  The patient stated that she was improving but had body aches, nausea, and had a warm feeling with no associated fever.  The patient had a CBC, Complete Metabolic Panel (CMP) and CK blood tests.  The patient's CK was slightly lower than normal (other results not reported).  The patient was not treated at the time.  The patient was referred to a neurologist.  Additional information has been requested.  The patient was seen at hospital.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MEN, TD, HPV4, MNQ, TDAP
Symptoms: Cough, Feeling hot, Full blood count, Laboratory test normal, Metabolic function test
Clinical narrative: Information has been received from a consumer concerning his daughter, a 13 year old female who was allergic to pineapple and CEPHALOSPORIN and with a mild asthma, received the first dose of GARDASIL on 05-MAY-2009.  Concomitant therapy included FLOVENT.  On 06-MAY-2009, the patient experienced severe pain in both arms, legs, chest, and abdomen.  Her skin could not be touched because she was in so much pain.  She was taken to the Emergency Room where she was given pain medication and tests were done for 5 hours.  All tests came back negative.  About 3-4 days the pain seemed to have gone away.   On 20-MAY-2009, the severe pain came back.  The patient would not be receiving her second or third dose of GARDASIL.  No lot number was provided.  At the time of reporting, the patient's severe pain persisted.  Follow- up information has been received from a medical assistant who stated that the lot # of GARDASIL was 661952/1129X.  The patient received the following vaccines concomitantly on 05-MAY-2009:  MENACTRA, (lot # U2875AA) and BOOSTRIX, (Lot # AC52B030AA).  On 06-MAY-2009 the patient went to a hospital and complained of shaking, chills, cough and dark colored urine.  The patient was treated with IV fluids, DILAUDID and ZOFRAN.  The patient had a urine analysis test and a CBC blood test (results not reported).  The patient was not admitted to the hospital.  On 07-MAY-2009 the physician evaluated the patient.  The patient did not received any treatment at the time.  On 22-MAY-2009, the patient was seen by the physician's assistant.  The patient stated that she was improving but had body aches, nausea, and had a warm feeling with no associated fever.  The patient had a CBC, Complete Metabolic Panel (CMP) and CK blood tests.  The patient's CK was slightly lower than normal (other results not reported).  The patient was not treated at the time.  The patient was referred to a neurologist.  Additional information has been requested.  The patient was seen at hospital.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MEN, TD, HPV4, MNQ, TDAP
Symptoms: Nausea, Pain, Pain in extremity, Pain of skin, Tremor
Clinical narrative: Information has been received from a consumer concerning his daughter, a 13 year old female who was allergic to pineapple and CEPHALOSPORIN and with a mild asthma, received the first dose of GARDASIL on 05-MAY-2009.  Concomitant therapy included FLOVENT.  On 06-MAY-2009, the patient experienced severe pain in both arms, legs, chest, and abdomen.  Her skin could not be touched because she was in so much pain.  She was taken to the Emergency Room where she was given pain medication and tests were done for 5 hours.  All tests came back negative.  About 3-4 days the pain seemed to have gone away.   On 20-MAY-2009, the severe pain came back.  The patient would not be receiving her second or third dose of GARDASIL.  No lot number was provided.  At the time of reporting, the patient's severe pain persisted.  Follow- up information has been received from a medical assistant who stated that the lot # of GARDASIL was 661952/1129X.  The patient received the following vaccines concomitantly on 05-MAY-2009:  MENACTRA, (lot # U2875AA) and BOOSTRIX, (Lot # AC52B030AA).  On 06-MAY-2009 the patient went to a hospital and complained of shaking, chills, cough and dark colored urine.  The patient was treated with IV fluids, DILAUDID and ZOFRAN.  The patient had a urine analysis test and a CBC blood test (results not reported).  The patient was not admitted to the hospital.  On 07-MAY-2009 the physician evaluated the patient.  The patient did not received any treatment at the time.  On 22-MAY-2009, the patient was seen by the physician's assistant.  The patient stated that she was improving but had body aches, nausea, and had a warm feeling with no associated fever.  The patient had a CBC, Complete Metabolic Panel (CMP) and CK blood tests.  The patient's CK was slightly lower than normal (other results not reported).  The patient was not treated at the time.  The patient was referred to a neurologist.  Additional information has been requested.  The patient was seen at hospital.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MEN, TD, HPV4, MNQ, TDAP
Symptoms: Urine analysis
Clinical narrative: Information has been received from a consumer concerning his daughter, a 13 year old female who was allergic to pineapple and CEPHALOSPORIN and with a mild asthma, received the first dose of GARDASIL on 05-MAY-2009.  Concomitant therapy included FLOVENT.  On 06-MAY-2009, the patient experienced severe pain in both arms, legs, chest, and abdomen.  Her skin could not be touched because she was in so much pain.  She was taken to the Emergency Room where she was given pain medication and tests were done for 5 hours.  All tests came back negative.  About 3-4 days the pain seemed to have gone away.   On 20-MAY-2009, the severe pain came back.  The patient would not be receiving her second or third dose of GARDASIL.  No lot number was provided.  At the time of reporting, the patient's severe pain persisted.  Follow- up information has been received from a medical assistant who stated that the lot # of GARDASIL was 661952/1129X.  The patient received the following vaccines concomitantly on 05-MAY-2009:  MENACTRA, (lot # U2875AA) and BOOSTRIX, (Lot # AC52B030AA).  On 06-MAY-2009 the patient went to a hospital and complained of shaking, chills, cough and dark colored urine.  The patient was treated with IV fluids, DILAUDID and ZOFRAN.  The patient had a urine analysis test and a CBC blood test (results not reported).  The patient was not admitted to the hospital.  On 07-MAY-2009 the physician evaluated the patient.  The patient did not received any treatment at the time.  On 22-MAY-2009, the patient was seen by the physician's assistant.  The patient stated that she was improving but had body aches, nausea, and had a warm feeling with no associated fever.  The patient had a CBC, Complete Metabolic Panel (CMP) and CK blood tests.  The patient's CK was slightly lower than normal (other results not reported).  The patient was not treated at the time.  The patient was referred to a neurologist.  Additional information has been requested.  The patient was seen at hospital.
Age: 0.8
Sex: U
Vaccine: PNC, RV5, RV5
Symptoms: Enema administration, Intussusception, Pyrexia, Rectal haemorrhage, Urinary system X-ray
Clinical narrative: Information has been received from a voicemail, a physician concerning a 9 month old infant who was vaccinated with the 1st dose of ROTATEQ. The patient experienced intussusceptions and was hospitalized in between late April 2009 to early May 2009. They wanted the safety department to contact them for all the details. Additional information has been requested.
Age: 0.8
Sex: U
Vaccine: PNC, RV5, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a voicemail, a physician concerning a 9 month old infant who was vaccinated with the 1st dose of ROTATEQ. The patient experienced intussusceptions and was hospitalized in between late April 2009 to early May 2009. They wanted the safety department to contact them for all the details. Additional information has been requested.
Age: 0.8
Sex: U
Vaccine: PNC, RV5, RV5
Symptoms: Inappropriate schedule of drug administration, Intussusception
Clinical narrative: Information has been received from a voicemail, a physician concerning a 9 month old infant who was vaccinated with the 1st dose of ROTATEQ. The patient experienced intussusceptions and was hospitalized in between late April 2009 to early May 2009. They wanted the safety department to contact them for all the details. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chest pain, Chills, Dyspnoea, Pain, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female with papanicolaou smear abnormal and a colposcopy (21-MAY-2009), who on 21-MAY-2009 was vaccinated with 0.5 ml of the first dose of GARDASIL (Lot. 661953/1130X), no other vaccine was administered at the same time. Concomitant therapy included multiple vitamins (unspecified). On 24-MAY-2009, the patient experienced a headache, slight diarrhea and fever. The patient went to the emergency room (ER), but was not admitted. The patient did not have a urinary tract infection (UTI) or a cervical infection. Her white blood cell count (WBC) was normal. The ER's discharge summary stated, "viral illness". On 26-MAY-2009, the nurse practitioner spoke with the patient who reported an intermittent fever of about 100 degrees, chest pain and some difficulty breathing. The patient was told to contact her primary care physician. At the time of this report, the patient's status was unknown. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chest pain, Diarrhoea, Dyspnoea, Headache, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female with papanicolaou smear abnormal and a colposcopy (21-MAY-2009), who on 21-MAY-2009 was vaccinated with 0.5 ml of the first dose of GARDASIL (Lot. 661953/1130X), no other vaccine was administered at the same time. Concomitant therapy included multiple vitamins (unspecified). On 24-MAY-2009, the patient experienced a headache, slight diarrhea and fever. The patient went to the emergency room (ER), but was not admitted. The patient did not have a urinary tract infection (UTI) or a cervical infection. Her white blood cell count (WBC) was normal. The ER's discharge summary stated, "viral illness". On 26-MAY-2009, the nurse practitioner spoke with the patient who reported an intermittent fever of about 100 degrees, chest pain and some difficulty breathing. The patient was told to contact her primary care physician. At the time of this report, the patient's status was unknown. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Smear cervix normal, Urine analysis normal, Viral infection, White blood cell count normal
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female with papanicolaou smear abnormal and a colposcopy (21-MAY-2009), who on 21-MAY-2009 was vaccinated with 0.5 ml of the first dose of GARDASIL (Lot. 661953/1130X), no other vaccine was administered at the same time. Concomitant therapy included multiple vitamins (unspecified). On 24-MAY-2009, the patient experienced a headache, slight diarrhea and fever. The patient went to the emergency room (ER), but was not admitted. The patient did not have a urinary tract infection (UTI) or a cervical infection. Her white blood cell count (WBC) was normal. The ER's discharge summary stated, "viral illness". On 26-MAY-2009, the nurse practitioner spoke with the patient who reported an intermittent fever of about 100 degrees, chest pain and some difficulty breathing. The patient was told to contact her primary care physician. At the time of this report, the patient's status was unknown. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, DTAP, MNQ
Symptoms: Dysarthria, Gait disturbance, Headache, Lethargy, Nuclear magnetic resonance imaging abnormal
Clinical narrative: This case was received from a physician on 06 June 2009. An 11-year-old male patient received an injection of MENACTRA (lot number not reported) and TDaP (manufacturer and lot number not reported) on 06 May 2009. On 23 May 2009, 17 days post-vaccination, he began experiencing headaches. Over the next week, symptoms progressed to include lethargy, slurred speech, facial paralysis, and imbalanced gait. He was admitted to the hospital on 02 June 2009, and an MRI revealed multifocal lesions in the basal ganglia and mid brain. An EEG showed spikes and generalized slowing. The presumptive diagnosis at the time of the report was acute disseminated encephalomyelitis (ADEM), although it was noted that the neurological findings were not consistent with typical ADEM. Per the reporter's discussion with the neurologist, the pattern shown on EEG could also be seen with metabolic or mitochondrial disease. It was noted that "the characteristics of the lesions are not classic for ADEM", and additional testing was being performed. Treatment included steroids, with questionable improvement. At the time of the report, the event was still ongoing. Additional medical records had been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, DTAP, MNQ
Symptoms: Balance disorder, Central nervous system lesion, Dysarthria, Electroencephalogram abnormal, Facial palsy
Clinical narrative: This case was received from a physician on 06 June 2009. An 11-year-old male patient received an injection of MENACTRA (lot number not reported) and TDaP (manufacturer and lot number not reported) on 06 May 2009. On 23 May 2009, 17 days post-vaccination, he began experiencing headaches. Over the next week, symptoms progressed to include lethargy, slurred speech, facial paralysis, and imbalanced gait. He was admitted to the hospital on 02 June 2009, and an MRI revealed multifocal lesions in the basal ganglia and mid brain. An EEG showed spikes and generalized slowing. The presumptive diagnosis at the time of the report was acute disseminated encephalomyelitis (ADEM), although it was noted that the neurological findings were not consistent with typical ADEM. Per the reporter's discussion with the neurologist, the pattern shown on EEG could also be seen with metabolic or mitochondrial disease. It was noted that "the characteristics of the lesions are not classic for ADEM", and additional testing was being performed. Treatment included steroids, with questionable improvement. At the time of the report, the event was still ongoing. Additional medical records had been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, DTAP, MNQ
Symptoms: Gait disturbance, Headache, Lethargy, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: This case was received from a physician on 06 June 2009. An 11-year-old male patient received an injection of MENACTRA (lot number not reported) and TDaP (manufacturer and lot number not reported) on 06 May 2009. On 23 May 2009, 17 days post-vaccination, he began experiencing headaches. Over the next week, symptoms progressed to include lethargy, slurred speech, facial paralysis, and imbalanced gait. He was admitted to the hospital on 02 June 2009, and an MRI revealed multifocal lesions in the basal ganglia and mid brain. An EEG showed spikes and generalized slowing. The presumptive diagnosis at the time of the report was acute disseminated encephalomyelitis (ADEM), although it was noted that the neurological findings were not consistent with typical ADEM. Per the reporter's discussion with the neurologist, the pattern shown on EEG could also be seen with metabolic or mitochondrial disease. It was noted that "the characteristics of the lesions are not classic for ADEM", and additional testing was being performed. Treatment included steroids, with questionable improvement. At the time of the report, the event was still ongoing. Additional medical records had been requested.
Age: 66.0
Sex: F
Vaccine: DT
Symptoms: Urticaria
Clinical narrative: Initial report was received 04 June 2009 from a consumer, who is also the patient. A 67-year-old female patient with a history of penicillin, seafood and bee sting allergies, had received a left deltoid injection of DECAVAC, lot number U1923HA during January 2008, and the day after vaccination, she was "covered in hives which lasted for a year". She received various medications as corrective treatment to relieve the hives and at the time of the report, she reported that she continues to have occasional episodes of hives. The patient had no illness at the time of vaccination and she had been taking Synthroid and Crestor concomitantly. She had not received any other vaccines within four weeks of DECAVAC. The patient's recovery status was reported as unknown at the time of the report. According to the reporter, she also had a sister who experienced "the same reaction to Tetanus vaccine". No further information was provided at the time of the report. Documents held by sender: None.
Sex: F
Vaccine: PER
Symptoms: Convulsion
Clinical narrative: Initial report received on 08 June 2009 from another manufacturer whose initial reporter was a health care professional. A 24 year old female patient received a pertussis vaccine as an infant (manufacturer and lot number not known). After receiving the vaccine, the patient experienced a seizure. No further information was provided. Recovery status was not reported. List of Documents held by Sender: none.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a physician for the Pregnancy Registry for GARDASIL regarding an 18 year old female with depression and a history of attention deficit disorder (1988) who on 31-OCT-2007 was vaccinated intramuscularly with her first dose of GARDASIL (Lot # 657006/0188U; site not reported). On 31-DEC-2007, the patient was vaccinated intramuscularly with her second dose of GARDASIL (Lot # 658554/0928U; site not reported). On 31-MAY-2008 (also reported as 4 days ago), the patient took a home pregnancy test which was negative. On 03-JUN-2008, the patient was vaccinated intramuscularly with her third dose of GARDASIL (Lot # reported as "0178U"; site not reported). Concomitant therapy included an unspecified antidepressant. On 03-JUN-2008, the patient took four home pregnancy tests which were all positive. The LMP date was not reported. The patient sought unspecified medical attention in the office. The patient outcome was not reported. No additional information was provided. All telephone attempts to contact the physician have been unsuccessful. Follow up information was received from the licensed practical nurse concerning the 18 year old patient who experienced miscarriage in approximately June 2008 which was about 2-3 weeks after the initial report was called in June 2008. The patient was doing fine. Upon internal review, miscarriage was determined to be an other important medical event. Additional information is not expected.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Incorrect route of drug administration, Post herpetic neuralgia
Clinical narrative: Information has been received from a physician concerning an approximately 80 years old female who was vaccinated with a 0.65ml dose of ZOSTAVAX (Merck) subcutaneously a year and a half ago. In December 2008, after receiving ZOSTAVAX (Merck), the patient developed shingles with "neuralgia". The patient had sought unspecified medical attention. It was reported that the patient improved but final outcome was not reported. Follow-up information has been received from the physician concerning an 86 year old female who on 02-AUG-2007 was vaccinated with the first dose of ZOSTAVAX (Merck) (lot number 657676/0619U) intramuscularly. Concomitant therapy included many unspecified medications. On 01-NOV-2008 the patient developed shingles with post herpetic neuralgia. Shingles and post herpetic neuralgia were considered to be disabling and an other important medical event by the physician. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion, Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a physician, for the Pregnancy Registry for GARDASIL, concerning an 18 year old female who on 13-JUN-2008 was vaccinated with the first dose of GARDASIL (lot # 658222/0927U). Subsequently the patient had a positive pregnancy test. The patient's LMP was not reported. Patient outcome was not reported. The patient sought unspecified medical attention by contacting the office. Follow-up information has been received from a physician who reported that the patient had an abortion. The abortion was not due to congenital anomaly or abnormal sonogram result. Patient decided on her own that she had too many unplanned pregnancies. Upon internal review, abortion was determined to be an other important medical event. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: DTAP, HEP, VARCEL
Symptoms: Abortion induced, Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a physician concerning a 29 year old female who on 14-MAY-2009 was vaccinated with VARIVAX (Oka/Merck) (manufacturer unknown) (dose route and lot no. not reported). Concomitant therapy included RECOMBIVAX HB (unspecified) (dose route and lot no. not reported) and DTaP (dose route and lot no. not reported). On 03-JUN-2009 the patient found out she was pregnant, she conducted a home urinary pregnancy test, patient's LMP was on 01-MAY-2009. The physician reported that on 05-JUN-2009 (three days after patient's finding) she decided to have an elective termination of her pregnancy at another practice. The patient would have a follow up visit with them on 26-JUN-2009. Upon internal review abortion was considered to be an other important medical event. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Drug exposure during pregnancy, Pregnancy induced hypertension
Clinical narrative: Information has been received from a nurse, for the pregnancy registry for GARDASIL, concerning a female with no known allergies and no pertinent medical history who in approximately July 2007, was vaccinated IM with a dose of GARDASIL (lot#, and site not reported) 0.5 ml. There was no concomitant medication. The patient sought unspecified medical attention. The nurse reported that the patient is pregnant and "she's probably in labor now" but was not positive. The LMP (last menstrual period) and estimated date of delivery were not reported. Method of pregnancy confirmation was also not reported. The nurse did not have the patient's chart in front of her, so exact details could not be provided. Follow up information was received, for GARDASIL, a Pregnancy Registry product, which reported that the patient delivered a baby via C-section on 24-MAY-2008. The reporter said that the patient had mild pregnancy-induced hypertension (PIH), but she was not sure why the C-section was performed. The baby just turned one and was normal and healthy with no congenital anomalies. The patient worked in the office and everything turned out fine. Upon internal review, C-section was determined to be an other important medical event. No further information is available.
Age: 0.8
Sex: F
Vaccine: HEP
Symptoms: Cerebrovascular accident, Convulsion, Motor dysfunction, Speech disorder
Clinical narrative: Information has been received from a physician concerning a 10 month old female with a history of wheezing who was vaccinated with 3 doses of RECOMBIVAX HB on unspecified date. There was no concomitant medication. In December 2006, the patient experienced seizure followed by a cerebral vascular accident. The patient was hospitalized on unspecified date. The patient initially had speech and motor delays but the reporter added "she is doing well now". On unknown date, the patient recovered. Seizure, initially had speech and motor delays and a cerebral vascular accident were reported as immediately life-threatening and disabling. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Intracranial pressure increased, Lymphadenectomy, Lymphadenopathy, Thyroid disorder
Clinical narrative: Information has been received from a consumer concerning his 15 year old daughter who was vaccinated with GARDASIL. After the patient received the first dose of GARDASIL the patient had a headache. The patient was hospitalized after the second dose of GARDASIL with a lymphadectomy, lymphadenopathy of the neck and the heart, a thyroid lesion, intracranial hypertension and was hospitalized. The patient was 17 years old at the time of reporting. No further information is available.
Age: 6.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Eye swelling, Rash pruritic, Sneezing
Clinical narrative: Patient started sneezing approx. 20 minutes after getting immunization. Left eye swelling and pt. c/o itching - rash on thigh. BENADRYL 40 mg given PO. Epinephrine 0.15 cc given SQ, SOLUMEDROL 15 mg given IM. 6/29/09-records received for DOS 6/10-6/11/09-DC DX: Acute allergic reaction to vaccine. Five minutes after receiving vaccine developed hives, periorbital edema, wheezing with shortness of breath.ICD-9 999.4.
Age: 6.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Eyelid oedema, Full blood count, Laboratory test, Rash generalised, Sneezing
Clinical narrative: Patient started sneezing approx. 20 minutes after getting immunization. Left eye swelling and pt. c/o itching - rash on thigh. BENADRYL 40 mg given PO. Epinephrine 0.15 cc given SQ, SOLUMEDROL 15 mg given IM. 6/29/09-records received for DOS 6/10-6/11/09-DC DX: Acute allergic reaction to vaccine. Five minutes after receiving vaccine developed hives, periorbital edema, wheezing with shortness of breath.ICD-9 999.4.
Age: 19.0
Sex: F
Vaccine: IPV, MMR, TD
Symptoms: Anorexia, Arthralgia, Ear pain, Headache, Lymph node pain
Clinical narrative: Achy joints (not just in shoulders with shots - though it is worst there), sore lymph nodes (at back of neck), sore throat, aching ears, loss of appetite (not very hungry), mild headache, mild fever (1 degree).
Age: 19.0
Sex: F
Vaccine: IPV, MMR, TD
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: Achy joints (not just in shoulders with shots - though it is worst there), sore lymph nodes (at back of neck), sore throat, aching ears, loss of appetite (not very hungry), mild headache, mild fever (1 degree).
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Blood test, CSF culture positive, Convulsion, Electroencephalogram abnormal, Facial palsy
Clinical narrative: THURSDAY, JUNE 4TH, RIGHT SIDE OF FACE STARTED SWELLING. PARENT TOOK HER INTO EMERGENCY ROOM. BY THE TIME THE M.D. GOT THERE SHE WAS ALERT AND ACTIVE. E.R. STAFF SAID SHE SEEMED LIKE A NORMAL BABY AND THEY COULDN'T NOTICE THE SWELLING BUT PARENT COULD. THEY DISCHARGED HER TO HOME THURSDAY NIGHT. FRIDAY, JUNE 5TH, SHE WENT TO HER REGULAR DR. FOR HER ROUTINE 4 MO. CHECK UP AND WAS FINE THERE. THEN AT 3:00 P.M. SHE STARTED HAVING SEIZURES, RIGHT EYE WAS DROOPING AND SHE WAS SHAKING. PROBABLY HAD 15 SEIZURES AT HOME PER MOM, AND HAD ABOUT 5 SEIZURES ON WAY TO HOSPITAL. ER STAFF TOOK HER INTO TRAUMA ROOM AND CHECK-IN NURSE SAW A SEIZURE. THEY DREW BLOOD AND DID A SPINAL TAP AND ADMITTED HER. SHE KEPT ON HAVING SEIZURES THROUGH OUT NIGHT. DID EEG ON SAT JUNE 6TH AND THEY CAUGHT A SEIZURE AND PUT HER ON PHENOBARBITAL. SUNDAY JUNE 7TH SHE HAD THREE MORE SEIZURES. THEY KEPT HER ON EEG MACHINE UNTIL MONDAY MORNING JUNE 8TH. THEN MONDAY MORNING SHE GOT AN MRI DONE. NO MORE SEIZURES SINCE SUNDAY JUNE 7TH. MRI CAME BACK NORMAL. TUESDAY DID ANOTHER SPINAL TAP, FIRST CULTURE HAD BACTERIA IN IT BUT THOUGHT IT WAS CONTAMINATION BECAUSE IT WAS JUST A LITTLE BIT. 2ND SPINAL CAME BACK NORMAL. WEDNESDAY JUNE 10TH SHE WAS RELEASED HOME AND NOTHING HAS HAPPENED SINCE WITH SEIZURE ACTIVITY. SHE IS ON PHENOBARBITAL 20 MG. AMT: 1 AND 1/2 TSP. QD PO. THE NEUROLOGIST SAID IF NO MORE SEIZURE ACTIVITY FOR 6 MONTHS, WILL TRY TO WEAN HER OFF MED.  7/1/09 Hospital records received DOS 6/6/09 to 6/10/09. Assessment: New onset seizures. Patient presented with multi episodes of eye blinking, unresponsiveness, drooling. Twitching, eyes rolling back. Tachycardic. Stares to right. Rash lower extremities. Hyperreflexia, clonus.  7/16/09 ICD-9 Codes: 780.39, 987.8