chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: F
Vaccine: FLUN3, HEPA, FLUN3
Symptoms: Angiogram, Antinuclear antibody positive, Apraxia, Blood alkaline phosphatase increased, Blood bilirubin normal
Clinical narrative: A serious spontaneous report of third nerve palsy, dilated pupil on the right side, loss of vision, eye misalignment and non-serious report of entire dose of FLUMIST being administered in right side has been received from a consumer, patient's mother, in the country concerning a three year-old female subsequent to FLUMIST. Past medical history included a febrile seizure when the patient was 13 months old. No concomitant medications were reported. No previous vaccines were given at the time of FLUMIST. The patient received a dose of FLUMIST on 04-Sep-2008. The dose of FLUMIST was entirely administered in the right nostril. On 07-Sep-2008 the patient was noted to have a "blown pupil" in the right eye. She was then evaluated by an ophthalmologist and neuro-ophthalmologist. A work-up that included multiple diagnostic testing and CT scans failed to identify a cause. A diagnosis of 3rd nerve palsy was made on Apr-2009. The mother states that the child also was told there was loss of vision in the eye due to misalignment of the right eye. The outcome of the entire of FLUMIST being administered in right side was resolved. All other events remain unresolved. The causality of the events to FLUMIST was not reported.
Age: 3.0
Sex: F
Vaccine: FLUN3, HEPA, FLUN3
Symptoms: Diplopia, Eyelid ptosis, IIIrd nerve paralysis, Laboratory test normal, Nuclear magnetic resonance imaging normal
Clinical narrative: A serious spontaneous report of third nerve palsy, dilated pupil on the right side, loss of vision, eye misalignment and non-serious report of entire dose of FLUMIST being administered in right side has been received from a consumer, patient's mother, in the country concerning a three year-old female subsequent to FLUMIST. Past medical history included a febrile seizure when the patient was 13 months old. No concomitant medications were reported. No previous vaccines were given at the time of FLUMIST. The patient received a dose of FLUMIST on 04-Sep-2008. The dose of FLUMIST was entirely administered in the right nostril. On 07-Sep-2008 the patient was noted to have a "blown pupil" in the right eye. She was then evaluated by an ophthalmologist and neuro-ophthalmologist. A work-up that included multiple diagnostic testing and CT scans failed to identify a cause. A diagnosis of 3rd nerve palsy was made on Apr-2009. The mother states that the child also was told there was loss of vision in the eye due to misalignment of the right eye. The outcome of the entire of FLUMIST being administered in right side was resolved. All other events remain unresolved. The causality of the events to FLUMIST was not reported.
Age: 3.0
Sex: F
Vaccine: FLUN3, HEPA, FLUN3
Symptoms: Pupil fixed, Pupillary disorder, Strabismus, Thyroid function test normal
Clinical narrative: A serious spontaneous report of third nerve palsy, dilated pupil on the right side, loss of vision, eye misalignment and non-serious report of entire dose of FLUMIST being administered in right side has been received from a consumer, patient's mother, in the country concerning a three year-old female subsequent to FLUMIST. Past medical history included a febrile seizure when the patient was 13 months old. No concomitant medications were reported. No previous vaccines were given at the time of FLUMIST. The patient received a dose of FLUMIST on 04-Sep-2008. The dose of FLUMIST was entirely administered in the right nostril. On 07-Sep-2008 the patient was noted to have a "blown pupil" in the right eye. She was then evaluated by an ophthalmologist and neuro-ophthalmologist. A work-up that included multiple diagnostic testing and CT scans failed to identify a cause. A diagnosis of 3rd nerve palsy was made on Apr-2009. The mother states that the child also was told there was loss of vision in the eye due to misalignment of the right eye. The outcome of the entire of FLUMIST being administered in right side was resolved. All other events remain unresolved. The causality of the events to FLUMIST was not reported.
Age: 3.0
Sex: F
Vaccine: FLUN3, HEPA, FLUN3
Symptoms: Blindness, Eye disorder, IIIrd nerve paralysis, Mydriasis, Wrong technique in drug usage process
Clinical narrative: A serious spontaneous report of third nerve palsy, dilated pupil on the right side, loss of vision, eye misalignment and non-serious report of entire dose of FLUMIST being administered in right side has been received from a consumer, patient's mother, in the country concerning a three year-old female subsequent to FLUMIST. Past medical history included a febrile seizure when the patient was 13 months old. No concomitant medications were reported. No previous vaccines were given at the time of FLUMIST. The patient received a dose of FLUMIST on 04-Sep-2008. The dose of FLUMIST was entirely administered in the right nostril. On 07-Sep-2008 the patient was noted to have a "blown pupil" in the right eye. She was then evaluated by an ophthalmologist and neuro-ophthalmologist. A work-up that included multiple diagnostic testing and CT scans failed to identify a cause. A diagnosis of 3rd nerve palsy was made on Apr-2009. The mother states that the child also was told there was loss of vision in the eye due to misalignment of the right eye. The outcome of the entire of FLUMIST being administered in right side was resolved. All other events remain unresolved. The causality of the events to FLUMIST was not reported.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Contusion, Fall, Head injury, Headache, Loose tooth
Clinical narrative: This case was received from a physician on 26 June 2009. A 14-year-old female, with a history of shrimp allergy, received the following vaccinations on 21 May 2009: a first dose of MENACTRA (lot number U2877AA) and a third dose of GARDASIL (Merck, lot number not reported). The patient was in a seated position two minutes post-vaccination, when she experienced a syncopal episode, fell to the floor, and hit her head. She had a possible injury to her tooth, and underwent a CT of the head. The patient had not experienced any adverse reactions following her first two doses of GARDASIL. At the time of the report, outcome was unknown.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Mouth injury, Syncope
Clinical narrative: This case was received from a physician on 26 June 2009. A 14-year-old female, with a history of shrimp allergy, received the following vaccinations on 21 May 2009: a first dose of MENACTRA (lot number U2877AA) and a third dose of GARDASIL (Merck, lot number not reported). The patient was in a seated position two minutes post-vaccination, when she experienced a syncopal episode, fell to the floor, and hit her head. She had a possible injury to her tooth, and underwent a CT of the head. The patient had not experienced any adverse reactions following her first two doses of GARDASIL. At the time of the report, outcome was unknown.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Computerised tomogram, Contusion, Dizziness, Face injury, Full blood count
Clinical narrative: This case was received from a physician on 26 June 2009. A 14-year-old female, with a history of shrimp allergy, received the following vaccinations on 21 May 2009: a first dose of MENACTRA (lot number U2877AA) and a third dose of GARDASIL (Merck, lot number not reported). The patient was in a seated position two minutes post-vaccination, when she experienced a syncopal episode, fell to the floor, and hit her head. She had a possible injury to her tooth, and underwent a CT of the head. The patient had not experienced any adverse reactions following her first two doses of GARDASIL. At the time of the report, outcome was unknown.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Headache, Metabolic function test, Syncope
Clinical narrative: This case was received from a physician on 26 June 2009. A 14-year-old female, with a history of shrimp allergy, received the following vaccinations on 21 May 2009: a first dose of MENACTRA (lot number U2877AA) and a third dose of GARDASIL (Merck, lot number not reported). The patient was in a seated position two minutes post-vaccination, when she experienced a syncopal episode, fell to the floor, and hit her head. She had a possible injury to her tooth, and underwent a CT of the head. The patient had not experienced any adverse reactions following her first two doses of GARDASIL. At the time of the report, outcome was unknown.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Computerised tomogram, Fall, Head injury, No reaction on previous exposure to drug, Syncope
Clinical narrative: This case was received from a physician on 26 June 2009. A 14-year-old female, with a history of shrimp allergy, received the following vaccinations on 21 May 2009: a first dose of MENACTRA (lot number U2877AA) and a third dose of GARDASIL (Merck, lot number not reported). The patient was in a seated position two minutes post-vaccination, when she experienced a syncopal episode, fell to the floor, and hit her head. She had a possible injury to her tooth, and underwent a CT of the head. The patient had not experienced any adverse reactions following her first two doses of GARDASIL. At the time of the report, outcome was unknown.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Back pain, Computerised tomogram normal, Diarrhoea, Full blood count normal, Headache
Clinical narrative: Throat swollen, difficulty breathing, body aches, severe headaches, chills/sweats, legs ache. vomiting/nausea, muscle spasms, light headed.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Lumbar puncture normal, Myalgia, Nausea, Neck pain, Pain in extremity
Clinical narrative: Throat swollen, difficulty breathing, body aches, severe headaches, chills/sweats, legs ache. vomiting/nausea, muscle spasms, light headed.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Paraesthesia, Vomiting
Clinical narrative: Throat swollen, difficulty breathing, body aches, severe headaches, chills/sweats, legs ache. vomiting/nausea, muscle spasms, light headed.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Blood test, Chills, Computerised tomogram, Dizziness, Dyspnoea
Clinical narrative: Throat swollen, difficulty breathing, body aches, severe headaches, chills/sweats, legs ache. vomiting/nausea, muscle spasms, light headed.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Headache, Hyperhidrosis, Lumbar puncture, Muscle spasms, Nausea
Clinical narrative: Throat swollen, difficulty breathing, body aches, severe headaches, chills/sweats, legs ache. vomiting/nausea, muscle spasms, light headed.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Nuclear magnetic resonance imaging, Pain, Pain in extremity, Pharyngeal oedema, Vomiting
Clinical narrative: Throat swollen, difficulty breathing, body aches, severe headaches, chills/sweats, legs ache. vomiting/nausea, muscle spasms, light headed.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Abortion induced, Drug exposure during pregnancy, Intra-uterine death, Pregnancy test positive
Clinical narrative: Information has been received from a 23 years old female for the Pregnancy Registry for GARDASIL who on 16-MAY-2008 was vaccinated intramuscularly with her first dose GARDASIL and found out three days later that she was pregnant. The patient's estimated LMP was 20-APR-2008 and she had a positive pregnancy test. Subsequently the patient experienced no adverse event symptoms and sought unspecified medical attention on an unspecified date by calling the office. Follow up information has been received from the patient who stated that she did get the GARDASIL last year but at 10 weeks in her pregnancy she had a miscarriage. At the time of her receiving the first dose of GARDASIL, she had a negative pregnancy test at the office. After one to two weeks, she performed a home pregnancy test which was positive. She called the physician's office to report it as she was concerned. On her initial prenatal visit, her physical exam was completely normal, and an ultrasound was not routinely done. When she sent to have an ultrasound at the office at 10 weeks, it was found there was no fetal heartbeat. She was asymptomatic. She stated the doctor told her it looked like the fetus had stopped developing about a week or two before that. After the ultrasound, she had some abdominal cramping type pain, but did not spontaneously pass the pregnancy. She "ended up needing a D&C". That went OK, she said, and at her 2 week checkup "everything was fine". Upon internal review, the intra-uterine death and abortion induced were considered as Other Important Medical Events. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Uterine dilation and curettage
Clinical narrative: Information has been received from a 23 years old female for the Pregnancy Registry for GARDASIL who on 16-MAY-2008 was vaccinated intramuscularly with her first dose GARDASIL and found out three days later that she was pregnant. The patient's estimated LMP was 20-APR-2008 and she had a positive pregnancy test. Subsequently the patient experienced no adverse event symptoms and sought unspecified medical attention on an unspecified date by calling the office. Follow up information has been received from the patient who stated that she did get the GARDASIL last year but at 10 weeks in her pregnancy she had a miscarriage. At the time of her receiving the first dose of GARDASIL, she had a negative pregnancy test at the office. After one to two weeks, she performed a home pregnancy test which was positive. She called the physician's office to report it as she was concerned. On her initial prenatal visit, her physical exam was completely normal, and an ultrasound was not routinely done. When she sent to have an ultrasound at the office at 10 weeks, it was found there was no fetal heartbeat. She was asymptomatic. She stated the doctor told her it looked like the fetus had stopped developing about a week or two before that. After the ultrasound, she had some abdominal cramping type pain, but did not spontaneously pass the pregnancy. She "ended up needing a D&C". That went OK, she said, and at her 2 week checkup "everything was fine". Upon internal review, the intra-uterine death and abortion induced were considered as Other Important Medical Events. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Breech presentation, Caesarean section, Drug exposure during pregnancy
Clinical narrative: Information has been received from a registered nurse through the Merck Pregnancy Registry concerning a 16 year old female patient who on 28-MAR-2008 was vaccinated with the first dose of GARDASIL. On 22-MAY-2008 the patient was vaccinated with the second dose of GARDASIL. There was no concomitant medication. The patient was pregnant. The patient has not experienced any know symptoms. The patient sought medical attention seen by the physician. Follow-up information was received from a health professional. The patient delivered on 05-DEC-2008 via C-section due to breech presentation. The baby was 6 lb 5 oz and completely normal and healthy with no congenital anomalies. Upon internal review, C-section due to breech presentation were determined to be an other important medical event. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Neonatal disorder, Poor weight gain neonatal, Premature labour
Clinical narrative: Initial and follow-up information has been received from a Nurse Practitioner for the pregnancy registry for GARDASIL From a nurse practitioner concerning a 16 year old female patient with a history of no previous pregnancies who on 18-AUG-2008 was vaccinated with a 0.5 mL second dose of GARDASIL (LOT # 659964/1878U) while she was pregnant. The estimated conception date is 01-JUL-2008 and the estimated delivery date is 24-MAR-2009. The nurse reported that on 18-JUN-2008 the patient received a 0.5 mL first dose of GARDASIL (LOT # 659653/1448U). A healthcare worker in the Nurse Practitioner's office reported that the patient had no prenatal care until she was 5 months along. She delivered her baby 2 months premature. The baby had reflux issues and slow weight gain. Her neurological status was within normal limits. She did confirm that there were no congenital anomalies and the baby was, otherwise, normal. Upon internal review, premature was determined to be an other important medical event. No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Activities of daily living impaired, Hemiparesis, Nuclear magnetic resonance imaging normal, Pain, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 22 year old female with no pertinent medical history who on 06-APR-2009 was vaccinated with the first dose of GARDASIL (lot # 661953/1130X) and on 09-JUN-2009 received a second dose of GARDASIL (lot # 662404/0312Y) in her left arm. Concomitant therapy included birth control (unspecified). There were no concomitant vaccinations administered with the GARDASIL. On 13-JUN-2009, the patient had motor weakness. She started experienced tingling on her face, left arm, hand, leg and foot. It then progressed to pain and tingling on the entire left side of her body. The patient is left handed. The patient was able to work. The physician reported that the patient was seen by a neurologist who did a magnetic resonance imaging and a magnetic resonance angiography on the patient and the results came back normal. The physician indicated that the patient had not recovered, and the patient had been monitored every day and she could not go on vacation. The patient sought medical attention with her physician. Follow up call information from the neurologist indicated that the patient had left-sided weakness. The patient's magnetic resonance imaging and magnetic resonance angiography were normal. The neurologist stated that as of 29-JUN-2009, there was no definitive diagnosis. The patient would have a repeat magnetic resonance imaging for the next week. Upon internal review, left-sided weakness was determined to be an other important medical event. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Vascular imaging
Clinical narrative: Information has been received from a physician concerning a 22 year old female with no pertinent medical history who on 06-APR-2009 was vaccinated with the first dose of GARDASIL (lot # 661953/1130X) and on 09-JUN-2009 received a second dose of GARDASIL (lot # 662404/0312Y) in her left arm. Concomitant therapy included birth control (unspecified). There were no concomitant vaccinations administered with the GARDASIL. On 13-JUN-2009, the patient had motor weakness. She started experienced tingling on her face, left arm, hand, leg and foot. It then progressed to pain and tingling on the entire left side of her body. The patient is left handed. The patient was able to work. The physician reported that the patient was seen by a neurologist who did a magnetic resonance imaging and a magnetic resonance angiography on the patient and the results came back normal. The physician indicated that the patient had not recovered, and the patient had been monitored every day and she could not go on vacation. The patient sought medical attention with her physician. Follow up call information from the neurologist indicated that the patient had left-sided weakness. The patient's magnetic resonance imaging and magnetic resonance angiography were normal. The neurologist stated that as of 29-JUN-2009, there was no definitive diagnosis. The patient would have a repeat magnetic resonance imaging for the next week. Upon internal review, left-sided weakness was determined to be an other important medical event. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Borrelia burgdorferi serology, Hypoaesthesia, Inflammation, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain
Clinical narrative: Information has been received from a physician concerning a 22 year old female with no pertinent medical history who on 06-APR-2009 was vaccinated with the first dose of GARDASIL (lot # 661953/1130X) and on 09-JUN-2009 received a second dose of GARDASIL (lot # 662404/0312Y) in her left arm. Concomitant therapy included birth control (unspecified). There were no concomitant vaccinations administered with the GARDASIL. On 13-JUN-2009, the patient had motor weakness. She started experienced tingling on her face, left arm, hand, leg and foot. It then progressed to pain and tingling on the entire left side of her body. The patient is left handed. The patient was able to work. The physician reported that the patient was seen by a neurologist who did a magnetic resonance imaging and a magnetic resonance angiography on the patient and the results came back normal. The physician indicated that the patient had not recovered, and the patient had been monitored every day and she could not go on vacation. The patient sought medical attention with her physician. Follow up call information from the neurologist indicated that the patient had left-sided weakness. The patient's magnetic resonance imaging and magnetic resonance angiography were normal. The neurologist stated that as of 29-JUN-2009, there was no definitive diagnosis. The patient would have a repeat magnetic resonance imaging for the next week. Upon internal review, left-sided weakness was determined to be an other important medical event. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Sensory loss
Clinical narrative: Information has been received from a physician concerning a 22 year old female with no pertinent medical history who on 06-APR-2009 was vaccinated with the first dose of GARDASIL (lot # 661953/1130X) and on 09-JUN-2009 received a second dose of GARDASIL (lot # 662404/0312Y) in her left arm. Concomitant therapy included birth control (unspecified). There were no concomitant vaccinations administered with the GARDASIL. On 13-JUN-2009, the patient had motor weakness. She started experienced tingling on her face, left arm, hand, leg and foot. It then progressed to pain and tingling on the entire left side of her body. The patient is left handed. The patient was able to work. The physician reported that the patient was seen by a neurologist who did a magnetic resonance imaging and a magnetic resonance angiography on the patient and the results came back normal. The physician indicated that the patient had not recovered, and the patient had been monitored every day and she could not go on vacation. The patient sought medical attention with her physician. Follow up call information from the neurologist indicated that the patient had left-sided weakness. The patient's magnetic resonance imaging and magnetic resonance angiography were normal. The neurologist stated that as of 29-JUN-2009, there was no definitive diagnosis. The patient would have a repeat magnetic resonance imaging for the next week. Upon internal review, left-sided weakness was determined to be an other important medical event. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Contraception, Convulsion, Electroencephalogram abnormal
Clinical narrative: Information has been received from a physician assistant concerning a 15 year old female who on an unspecified date was vaccinated with the first 0.5ml dose of GARDASIL (IM, lot number unspecified). Originally the patient's pediatrician sent the patient to the physician assistant to have DEPO-PROVERA inserted (on an unspecified date). The patient went back to her pediatrician (on an unspecified date) and received the first dose of GARDASIL. The GARDASIL vaccine and DEPO-PROVERA administration were started "around the same time". It is reported that the information for DEPO-PROVERA stated that seizures had been associated with it. Approximately 4 weeks after administration she developed seizures. An electroencephalography (EEG) was performed and the technician performing the test asked the patient's mother if the patient have had a head injury so the physician assistant thought there might have been some "activity" showing up (not further specified). The patient had not received any further doses of GARDASIL and the DEPO-PROVERA had been removed. At the time of the report, the patient's status was unknown. Upon internal review, seizures was determined to be an other important medical event. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Colectomy total, Colitis ulcerative, Condition aggravated, Inappropriate schedule of drug administration, Surgery
Clinical narrative: Information has been received from a physician and her office manager concerning a 19 years old female with no drug reactions and a history of anemia and ulcerative colitis which began at age 17 years who in July 2007, was vaccinated with the first dose of GARDASIL. In July 2008, the patient had a Total Colectomy and was hospitalized. In October 2008, the patient had J-Pouch surgery and on 05-JAN-2009, had "reversal" surgery. On 25-JUN-2009 (also reported as April 2008), the patient was seen in physician's office and received the second dose of GARDASIL (lot # 660616/0570X). At the time of reporting, the patient had recovered. Total Colectomy, J-Pouch surgery and "reversal" surgery were considered to be other important medical events, disabling and life-threatening. Follow up telephone call was made to the physician, and was transferred to the Office Manager. The Office Manager was not able to confirm that the patient's surgeries (Total Colectomy, J-Pouch surgery and reversal surgery) were related to a worsening of ulcerative colitis. Additional information has been requested.  7/7/09 Spoke with mother-emphatically denied that symptoms were related to HPV4, patient has a long history of colitis and does not want any follow-up on this report.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Syncope
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient with seasonal allergies who on 11-JUN-2008 was vaccinated with the first dose of GARDASIL (Lot number 659653/1448U) 0.5 mL intramuscular in the right arm. On 11-JUN-2008, the patient fainted after her initial GARDASIL, she reportedly fainted in the office with "seizures like movements", then became responsive immediately after. The patient sought medical attention in the office and was sent to the emergency room (name unspecified) but was not admitted. The patient did not continue with the series. Seizure was considered to be an other important medical event. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Barium enema, Intussusception, Irritability, Nausea, Ultrasound scan abnormal
Clinical narrative: Information has been received from a study for ROTATEQ concerning a 17 week old male who was vaccinated with a second dose of ROTATEQ. Eight days after vaccination, the infant was with one day of nausea, vomiting and fussiness. Pediatrician referred him to ED for ultrasound. On 14-AUG-2007 the patient was hospitalized. Ileocolic intussusception was confirmed by ultrasound and hydrostatically reduced via barium enema. The infant was discharged home next day. At the time of reporting, the outcome was unknown. Ileocolic intussusception was considered to be an other important medical event. The relationship of intussusception to ROTATEQ was not reported. Additional information is not expected.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a study for ROTATEQ concerning a 17 week old male who was vaccinated with a second dose of ROTATEQ. Eight days after vaccination, the infant was with one day of nausea, vomiting and fussiness. Pediatrician referred him to ED for ultrasound. On 14-AUG-2007 the patient was hospitalized. Ileocolic intussusception was confirmed by ultrasound and hydrostatically reduced via barium enema. The infant was discharged home next day. At the time of reporting, the outcome was unknown. Ileocolic intussusception was considered to be an other important medical event. The relationship of intussusception to ROTATEQ was not reported. Additional information is not expected.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Enema administration, Ileectomy, Intussusception, Rectal haemorrhage, Ultrasound scan abnormal
Clinical narrative: Information has been received from a study for ROTATEQ concerning a 17 week old male who was vaccinated with a second dose of ROTATEQ. Three days after vaccination, the infant experienced one day of vomiting and bright red blood per rectum, on 16-DEC-2007 the patient was hospitalized. Diagnosis was confirmed as intussusception by ultrasound. Reduction via air contrast enema was not successful. Ileo-colic intussusception was surgically resected due to ileocecal enteric duplication cyst. The infant was discharged at day 3. At the time of reporting, the outcome was unknown. Intussusception was considered to be an other important medical event. The relationship of intussusception to ROTATEQ was not reported. No further information is available.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a study for ROTATEQ concerning a 17 week old male who was vaccinated with a second dose of ROTATEQ. Three days after vaccination, the infant experienced one day of vomiting and bright red blood per rectum, on 16-DEC-2007 the patient was hospitalized. Diagnosis was confirmed as intussusception by ultrasound. Reduction via air contrast enema was not successful. Ileo-colic intussusception was surgically resected due to ileocecal enteric duplication cyst. The infant was discharged at day 3. At the time of reporting, the outcome was unknown. Intussusception was considered to be an other important medical event. The relationship of intussusception to ROTATEQ was not reported. No further information is available.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Facial palsy
Clinical narrative: Information has been received from a physician concerning a now 29 year old female patient who was diagnosed with Bell's palsy 2 days after receiving her first dose of VARIVAX (Merck) 10 years ago in 1999 approximately at age of 19 year old. There was no concomitant medication. The symptoms resolved after 6 months (date unknown) and the patient fully recovered. Unspecified medical attention had been sought. Upon internal review, bells palsy was determined to be an other important medical event. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: MEN, TD, TYP, YF
Symptoms: Full blood count, Influenza serology, Metabolic function test, Mononucleosis heterophile test, Pyrexia
Clinical narrative: Patient developed fevers about 2-3 days post vaccination.
Age: 17.0
Sex: M
Vaccine: MEN, TD, TYP, YF
Symptoms: Streptococcal identification test
Clinical narrative: Patient developed fevers about 2-3 days post vaccination.
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema, Skin warm, Swelling
Clinical narrative: SEEN ON 6/30/09 FOR 16 YEAR OLD WELL CHECK.  RECIEVED VARIVAX # 2.  ON 7/1/09 WOKE UP WITH RED, SWOLLEN TO TOUCH, WARM RIGHT ARM.  SEEN IN OUR OFFICE DIAGNOSED WITH CELLULITIS TO R ARM.  TREATED WITH KEFLEX.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Balance disorder, Fatigue, Injection site pruritus, Injection site rash
Clinical narrative: Client reports on Sat., July 4, 09, she noted a mild rash at site of injection.  Denies itching at this time and had no other complaints.  Reports that she had some nausea and stomach pains after eating on Sunday, July 5, 09 with each meal.  She also reports being extremely tired after returning from church and was experiencing some vertigo and "off balance" sensation.  She states the rash still present but no itching.  She states that this morning she is having some mild itching at site of injection and continues with the rash at the site of injection.  She has not eaten this morning, but states her appetite is fine and has been, that she has nausea and stomach pains after she eats.  She has an appointment to see her doctor today, July 6, 09 for a discolored finger which she also went to the ER for on Friday, July 3, 09.  She reports she had a tingling sensation in her right ring finger and her finger was cold and turned purple.  She denies any known trauma to her finger.  The discoloration had started 6-29-09 before she was vaccinated.  She also reports a genetic disorder called Leiden factor 5 (a clotting disorder).  She plans on discussing all of her immediate issues with Dr. today at her appointment.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Paraesthesia, Peripheral coldness, Skin discolouration, Vertigo
Clinical narrative: Client reports on Sat., July 4, 09, she noted a mild rash at site of injection.  Denies itching at this time and had no other complaints.  Reports that she had some nausea and stomach pains after eating on Sunday, July 5, 09 with each meal.  She also reports being extremely tired after returning from church and was experiencing some vertigo and "off balance" sensation.  She states the rash still present but no itching.  She states that this morning she is having some mild itching at site of injection and continues with the rash at the site of injection.  She has not eaten this morning, but states her appetite is fine and has been, that she has nausea and stomach pains after she eats.  She has an appointment to see her doctor today, July 6, 09 for a discolored finger which she also went to the ER for on Friday, July 3, 09.  She reports she had a tingling sensation in her right ring finger and her finger was cold and turned purple.  She denies any known trauma to her finger.  The discoloration had started 6-29-09 before she was vaccinated.  She also reports a genetic disorder called Leiden factor 5 (a clotting disorder).  She plans on discussing all of her immediate issues with Dr. today at her appointment.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Anaphylactic reaction, Erythema, Hyperhidrosis
Clinical narrative: redness, diaphoresis, early analphylaxis, given diphenhydramine and epinephrine.  observed in emergency room
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Fall, Immediate post-injection reaction, Loss of consciousness, Pallor
Clinical narrative: Fainted after recieving immunizations.Turned pale. Fell to the floor. Patient passed out for 10 seconds. Stated that she felt dizzy when she came to.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Fainted after recieving immunizations.Turned pale. Fell to the floor. Patient passed out for 10 seconds. Stated that she felt dizzy when she came to.
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: Blood test normal, Bone pain, Chest X-ray normal, Chills, Crying
Clinical narrative: Felt ill day after infection, by 7:00 p.m. 6/17/09, had high fever chills, muscle aches, pain down spine.  Severe muscle aches, child sobbing.  Took to ER ater child blacked out. Ran blood tests adn CXR, all normal.  Rehydrated adn sent home.  Took Ibuprofen for fever/aches.  Recovered by Friday 6/19/09 - SSM
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: Dehydration, Loss of consciousness, Malaise, Myalgia, Pyrexia
Clinical narrative: Felt ill day after infection, by 7:00 p.m. 6/17/09, had high fever chills, muscle aches, pain down spine.  Severe muscle aches, child sobbing.  Took to ER ater child blacked out. Ran blood tests adn CXR, all normal.  Rehydrated adn sent home.  Took Ibuprofen for fever/aches.  Recovered by Friday 6/19/09 - SSM
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Fall, Muscular weakness
Clinical narrative: Patient recieved shots, walked out of room feeling fine. Walked over to the check out desk after standing there for a few seconds knees gave out and started to fall. Patient lowered to the floor, did not pass out completely.Patient had not eaten yet today. Responded to questons. Was given some orange juice. Left office 15 min later feeling better.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Aortic valve incompetence, Atrial fibrillation, Atrial flutter, Blood creatine phosphokinase normal, Blood thyroid stimulating hormone normal
Clinical narrative: PATIENT DEVELOPED ATRIAL FLUTTER/FIBRILLATION IN JUNE 2009, AND WAS CONCERNED THAT IT MAY HAVE BEEN CAUSED BY VACCINE. 7/15/09-records received for DOS 6/12-6/15/09-DC DX: ANew onset atrial flutter/fibrillation. Cardiomyopathy, possibly related to tachydysrhythmia. Presented with 2 day history of palpitations and shortness of breath on exertion. In ED atrial flutter.   7/16/09 ICD-9 Codes: 427.32, 425.4, 785.2
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Echocardiogram abnormal, Ejection fraction decreased, Electrocardiogram abnormal, Mitral valve incompetence, Tricuspid valve incompetence
Clinical narrative: PATIENT DEVELOPED ATRIAL FLUTTER/FIBRILLATION IN JUNE 2009, AND WAS CONCERNED THAT IT MAY HAVE BEEN CAUSED BY VACCINE. 7/15/09-records received for DOS 6/12-6/15/09-DC DX: ANew onset atrial flutter/fibrillation. Cardiomyopathy, possibly related to tachydysrhythmia. Presented with 2 day history of palpitations and shortness of breath on exertion. In ED atrial flutter.   7/16/09 ICD-9 Codes: 427.32, 425.4, 785.2
Age: 52.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Anorexia, Asthenia, Back pain, Dizziness, Feeling of body temperature change
Clinical narrative: After receiving both vaccines, patient complained of the following symptoms later in the evening;Entire mouth and lips were swollen and blistered, Palpitations and hot/cold flashes, light-headed and dizzy, generalized weakness (legs buckled), lost appetite and sharp pains across lower back
Age: 52.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Lip blister, Lip swelling, Oedema mouth, Oropharyngeal blistering, Palpitations
Clinical narrative: After receiving both vaccines, patient complained of the following symptoms later in the evening;Entire mouth and lips were swollen and blistered, Palpitations and hot/cold flashes, light-headed and dizzy, generalized weakness (legs buckled), lost appetite and sharp pains across lower back
Age: 5.0
Sex: U
Vaccine: DTPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: reddness and swelling at injection site left deltoid.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, Injection site oedema, Pain in extremity
Clinical narrative: Edema at site approx 3 hours post injection.  Approx. 9cm by 4cm.  Pt crying and retracting RIGHT leg when leg touched.  Was taken to the doctor at 2pm after giving one dose of Benadryl.  Edema was gone by 3-4pm
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Furuncle, Oedema peripheral, Pruritus, Rash, Urticaria
Clinical narrative: severe rash developed by 7/1/09. rash got worse by 7/2- rash was on hands, between fingers and on arms and feet. right hand was swollen and puffy. Symptoms worse on arm shot was given. By 7/3 swelling , hives and boils were worse.Unbearable itching. hives on stomach, arms, legs, feet, hands, arms, between fingers, face and eyes.took doses of bendryl on 7/2 and 7/3 every 4 hours without it helping at all. was given prescription for prednisone on 7/4 at about 4pm. this is day 3 of taking prednisone and still have moderate symptoms.
Age: 48.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Feeling hot, Injection site pain, Injection site swelling
Clinical narrative: PATIENT COMPLAINS OF SWELLING AND PAIN IN LEFT ARM ON 7/3/09 AFTER GETTING IMMUNIZATIONS ON 7/2/09. STATES SHE FELT HOT LIKE SHE MIGHT HAVE HAD FEVER ON 7/3 & 7/4. STILL HAVING SWELLING & PAIN TODAY 7/6. HAS SWELLING IN LEFT DELTOID REGION TODAY 3" X 3 1/2". ADVISED TO USE COLD COMPRESSES & IBUPROFEN.
Age: 76.0
Sex: M
Vaccine: VARCEL, VARZOS, VARZOS
Symptoms: Angioedema, Blood culture negative, Complement factor C3, Urticaria
Clinical narrative: Hives Tx 50 mg prednisone x 3 days, angiodema with admission to hospital 6/19/2009, benadry,discharged on 6/21/2009 with hydroxizene 25 mg 3/d for 30 days and ranitidine 300 mg. 1/d for 30 days.  9/23/09 Hospital records received DOS 6/19/09 to 6/20/09. Assessment: Urticaria secondary to allergic reaction. Patient presented with difficulty breathing and feeling of swallowing in throat and hives. Cough, nausea, vomiting. Diffuse multiple urticarial lesions all over body with excoriation marks. Tongue, lips, chin swollen. Speech slurred. Angioedema. Allergic to vaccine.
Age: 76.0
Sex: M
Vaccine: VARCEL, VARZOS, VARZOS
Symptoms: Angioedema, Rash generalised, Urticaria
Clinical narrative: Hives Tx 50 mg prednisone x 3 days, angiodema with admission to hospital 6/19/2009, benadry,discharged on 6/21/2009 with hydroxizene 25 mg 3/d for 30 days and ranitidine 300 mg. 1/d for 30 days.  9/23/09 Hospital records received DOS 6/19/09 to 6/20/09. Assessment: Urticaria secondary to allergic reaction. Patient presented with difficulty breathing and feeling of swallowing in throat and hives. Cough, nausea, vomiting. Diffuse multiple urticarial lesions all over body with excoriation marks. Tongue, lips, chin swollen. Speech slurred. Angioedema. Allergic to vaccine.
Age: 76.0
Sex: M
Vaccine: VARCEL, VARZOS, VARZOS
Symptoms: Angioedema, Rash
Clinical narrative: Hives Tx 50 mg prednisone x 3 days, angiodema with admission to hospital 6/19/2009, benadry,discharged on 6/21/2009 with hydroxizene 25 mg 3/d for 30 days and ranitidine 300 mg. 1/d for 30 days.  9/23/09 Hospital records received DOS 6/19/09 to 6/20/09. Assessment: Urticaria secondary to allergic reaction. Patient presented with difficulty breathing and feeling of swallowing in throat and hives. Cough, nausea, vomiting. Diffuse multiple urticarial lesions all over body with excoriation marks. Tongue, lips, chin swollen. Speech slurred. Angioedema. Allergic to vaccine.
Age: 1.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC, VARCEL
Symptoms: Body temperature increased, Crying, Rash
Clinical narrative: Temp to 103 degrees started at 6pm, rash started at 5pm and crying from 10pm - 2am
Age: 25.0
Sex: M
Vaccine: DTAP
Symptoms: Aphthous stomatitis, Arthralgia, Headache, Nausea, Pyrexia
Clinical narrative: Pt presents to the clinic with 3 day hx of headache, joint pain, low grade fever, nausea, aphtous stomatitis.  Tx with SoluMedrol 125mg IM injection and 7 day course of Benadryl, with f/u instructions given.
Age: 70.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: Arthralgia, Injection site pain
Clinical narrative: OV made to inform PHN that approx 24 hrs after receiving Tdap, Hep A and Hep B. Pt L arm where Tdap was given was tender for 24 hrs. Pt c/o upper body joints were severely achy. Pt stated that symptoms lasted 3 weeks. Pt unsure if it was the reaction to vaccine or arthritis/rain. We had rain for 3 weeks.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness, warmth, tenderness to left upper thigh began approx. 24 hours after injection. Erythema measuring 10.5 cm in diameter. Advised to apply cool compresses and give BENADRYL/liquid.
Age: 1.4
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Rash, Urticaria
Clinical narrative: Wheal and flared urticaria scattered throughout her body. Pt seen today in office for rash for 4 days. Treated with BENADRYL at home and prescribed PRELONE today. Nurse at Health Dept notified by phone.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Erythema, Local reaction, Oedema peripheral, Pain in extremity, Urticaria
Clinical narrative: 14 yr old fe here today with Aunt (who has legal custody of child.) to show nurse Rt arm - Local reaction back of Rt arm red, raised, swollen area measures 10" x 11" has a red raised center approx 2" sore to touch - Arm started to swelling some that night after the injection - Had VARIVAX AND GARDASIL #1 same arm - MENINGITIS vaccine
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Oedema peripheral
Clinical narrative: Arm swelled up after it was given.  Required BENADRYL for about two days.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Injection site erythema
Clinical narrative: 1 X 3 cm area of erythema but no induration, (R) thigh
Age: 1.85
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia, Rash
Clinical narrative: Mom called office 9:10 am 6/29/09 regarding Hepatitis A shot received in office on 6/26/09 - States child developed fever- 102 degrees Saturday 6/27/09 - 06/29/09 - Fever didn't occur til 6/27/09 pm along with rash to trunk and back. Has been treated with TYLENOL for fever.
Age: 1.69
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Nuclear magnetic resonance imaging normal, Paralysis
Clinical narrative: On 6/11/09, we have this 20-month old her 4th DTAP, her 4th H flu, and her second Hepatitis A. 10 days later she developed a L nerve palsy in her L eye.
Sex: M
Vaccine: HEP, RUB
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Infant accidentally received RUBELLA vaccine in addition to HEPATITIS B vaccine.
Sex: F
Vaccine: HEP, RUB
Symptoms: Incorrect dose administered
Clinical narrative: Infant accidentally received Rubella vaccine in addition to Hepatitis B vaccine
Age: 54.0
Sex: F
Vaccine: HEPA
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Low grade fever, nausea, headache  Prior medical diagnoses:  Hyperlipidemia dysmetabolic syndrome, diabetes, hypertension
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Pt had DTAP vaccine 6/29/09 @ Lt thigh and developed redness, swelling, and hardness 7/1/09 per Pts. mother
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Area red, swollen, warm to touch at site of injection.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Mass, Rash pruritic
Clinical narrative: 1 day lump X 2 days 1 1/2 dollar size. Itchy/ rash
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral, Upper respiratory tract infection
Clinical narrative: Red, raised area to right upper arm. There was some soreness to the arm as well. Patient developed worse URI s/s on 6/30/09 as well.
Age: 15.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Accidental exposure, Blood count normal, Blood glucose normal, Immediate post-injection reaction, Presyncope
Clinical narrative: This case was reported by a physician and described the occurrence of vasovagal response in a 15-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Previous and/or concurrent vaccination included BOOSTRIX; GlaxoSmithKline given on 25 June 2009. On 25 June 2009 at 16:40 the subject received 1st dose of TWINRIX (1 ml, unknown, left arm). On 25 June 2009, immediately after vaccination with TWINRIX, the subject experienced vasovagal response, fainting and inadvertent exposure to vaccine. The 15-year-old subject inadvertently received TWINRIX. Additionally, the subject had a vasovagal response immediately after receiving TWINRIX and then fainted. The office subsequently checked the subject blood sugar and blood count, which were both normal. This case was assessed as medically serious by GSK. At the time of reporting the vasovagal response had resolved, the outcome of the fainting was unspecified.