chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEP
Symptoms: Expired drug administered, Injection site pain
Clinical narrative: Information has been received from a health professional concerning a female with hypertension, mitral valve pro lapse and a penicillin allergy, who on 19, Oct 2006 was vaccinated with a third, 1 ml, intramuscular dose of hepatitis B virus vaccine rHBsAg (yeast) (lot# 647274/0205P) that had expired. Concomitant therapy included atenolol (TENORMIN), 50 mg, amlodipine besylate (+) benazepril hydrochloride (LOTREL), 10/20 mg, HCTZ/triamterene (DYAZIDE) and alprazolem (XANAX), 0.25 mg. It was reported that the injection hurt. At the time of the report the patient was recovering. There were no laboratory and diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided.
Age: 14.0
Sex: M
Vaccine: HEP, HIBV
Symptoms: Haematochezia, Laboratory test
Clinical narrative: Information has been received from a pharmacist concerning an approximately 14 week old male who in October 2006 was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast). Additional suspect therapy included a dose of Hib con j vaccine (OMPC) (MSD). Subsequently, two weeks later, the patient was passing blood in his stool. Unspecified medical attention was sought. There was no product quality complaint involved. The patient's sibling (WAES # 0611USA04780) had a similar experience after vaccination.
Sex: U
Vaccine: HEP, HIBV
Symptoms: Haematochezia
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown). suspect vaccination administered at the same visit included a dose of Hib conj vaccine (CMPC) (manufacturer unknown). Subsequently the patient developed blood in the stool. The patient's outcome was not known. There was no product quality complaint involved. The patient's sibling (WAES# 0610USA11149) experienced a similar reaction after vaccination with hepatitis B virus vaccine rHBsAg (yeast) and Hib conj vaccine (CMPC) (MSD).
Sex: F
Vaccine: HEP
Symptoms: Skin laceration
Clinical narrative: Information has been received from a female consumer and registered nurse who on 23-OCT-2006 was cut by a vial of Recombivax HB (lot # 653391/0186F). It was reported that two doses of the vaccine 0.5 ml were broken when received. While trying to clean up the broken vials the nurse cut her finger. She described it as a minor poke. There was no additional information regarding the extent of severity of the cut. The patients outcome was not reported. Medical attention was sought. There was a product quality complaint involved. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Information has been received from physician concerning a 7 year old female with no allergies or medical history who on 15 AUG 2006 was vaccinated in the right upper arm with a first dose of Recombivax HB (lot # 651735/0537R). Concomitant therapy included FLOVENT and Albuterol. On 17-AUG-2006, the patient had a pin point rash on her thigh two days after vaccination. Unspecified medical attention was sought. The patient recovered a couple days later with BENADRYL treatment. Subsequently, the patient recovered from pin point rash. A product quality complaint was not involved. Additional information has been requested. Additional information has been received from a physician who reported that on 17-AUG-2006, in the afternoon, the patient developed a pinpoint rash on her thighs that was raised and pruritic. The rash responsed to BENADRYL which was required for a few days. The patient recovered on approximately 19-AUG-2006 or 20-AUG-2006. There was no reoccurence. It was also noted that the patient had a hepatitis B surface antibody of 24 MIU/ml and a negative hepatitis B core antibody and hepatitis surface antigen. Neither the patient nor her sibling had any adverse events following prior vaccination. No further information is expected.
Sex: F
Vaccine: HEP
Symptoms: Chills, Myalgia, Pyrexia, Serum sickness, Similar reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning a female who, at "10 years old", in approximately 2001 was vaccinated with a first dose of Recombivax HB (manufacturer unknown). Subsequently the patient experienced a serum sickness type reaction with a high fever, chills, and myalgia. The patient was vaccinated with a second dose of Recombivax HB (manufacturer unknown). After the second vaccination the patient experienced a serum sickness type reaction with a high fever, chills, and myalgia. The duration of the reactions were not known. It was reported that the patient was fully recovered as of 27-OCT-2006. Unspecified medical attention was not sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Hypoaesthesia, Medication error, Paraesthesia
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a adult male patient who on 17-OCT-2006 was vaccinated with a dose of Recombivax. It was reported that the Recombivax was improperly stored. Also, after vaccination the patient developed numbness and tingling in th arm in which he was vaccinated. Unspecified medical attention was sought. He was seen by the physician for follow-up on 24-OCT-2006, no outcome was reported. No product quality complaint was involved. Additional information is not expected.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a 54-year-old female with a penicillin allergy, sulfonamide allergy, belladona allergy, iodine allergy and an allergy to ULTRACET; who on 14-SEP-2006 was vaccinated intramuscularly in the left deltoid with a third dose of Recombivax HB (lot#647547/0031P). One to two days following vaccination, on approximately 15-SEP-2006, the patient experienced soreness to her left arm after injection. It was unspecified if medical attention was sought, no laboratory or diagnostic test were performed. No outcome was reported. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Adverse event
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a 51-year-old female house keeper who on 09-OCT-2006 was vaccinated intramuscularly in the left deltoid with a third dose of Recombivax HB (lot# 647547/0031P). Subsequently, the patient experienced adverse experience. It was unspecified if medical attention was sought. No outcome was reported. Additional information has been requested.
Sex: U
Vaccine: HEP, HIBV
Symptoms: Haematochezia
Clinical narrative: Information has been received from a pharmacist concerning patient who on an unspecified date was vaccinated with a dose of Recombivax HB (manufacturer unknown). Additional suspect therapy included a dose of PedvaxHib (manufacturer unknown). Subsequently, the patient developed blood in the stool, but it was thought to be a possible allergy. No further information is available. The patient's siblings, (WAES # 0610USA12034) had a similar experience after vaccination.
Age: 0.09
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a 35-day-old female with no medical history or allergies, who on 20-NOV-2006 was vaccinated intramuscularly with a second dose of Recombivax HB. There was no concomitant medication. On 21-NOV-2006 the baby broke out in a rash. Unspecified medical attention was sought and no laboratory or diagnostic test were performed. Subsequently, the patient recovered. No product quality complaints were involved. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Blood pressure increased, Dysarthria, Dyspnoea, Electrocardiogram, Heart rate increased
Clinical narrative: Information has been received from a 49-year-old female registered nurse with no pertinent medical history or allergies, who in 1993 or 1994 was vaccinated with a second dose of Recombivax HB (manufacturer unspecified)Concomitant therapy included hormonal contraceptives (unspecified). After receiving the second vaccination, the patient experienced shortness of breathe, slurred speech, elevated heart rate (over 130) and elevated blood pressure. The patient was seen in the emergency room but was not admitted. An EKG was performed but no results were reported. Subsequently, the patient recovered from the reaction on her own, no medication or treatment was required. No product quality complaints were involved. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Urticaria
Clinical narrative: Information has been received from a physician concerning a 26 year old female with in known allergies ore pertinent medical history, who on an unspecified date was vaccinated with a dose of Recombivax HB. Subsequently the patient developed hives and a fever after immunization. Unspecified medical attention was sought. Subsequently, the patient recovered. There was no product quality complaint involved. No further information was available. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Blood test, Dizziness, Electrocardiogram, Hypotension, Laboratory test
Clinical narrative: Information has been received from a registered nurse concerning a 33-year-old female with penicillin allergy who on 13-DEC-2006 was vaccinated with her second dose of Recombivax HB (Lot # 655810/1022F). There was no concomitant medication. On 15-DEC-2006, the patient became lightheaded and fainted; developed red blotches and rash on her chest, arm, neck, and shoulder; and her blood pressure was low. These events were considered to cause significant disability or incapacity. The patient sought medical attention in the emergency room and an EKG and blood work were performed (results not reported) but was admitted to the hospital. At the time of the report, the patient had not recovered. No further information to report. There was not a product quality complaint involved. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Rash macular, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 33-year-old female with penicillin allergy who on 13-DEC-2006 was vaccinated with her second dose of Recombivax HB (Lot # 655810/1022F). There was no concomitant medication. On 15-DEC-2006, the patient became lightheaded and fainted; developed red blotches and rash on her chest, arm, neck, and shoulder; and her blood pressure was low. These events were considered to cause significant disability or incapacity. The patient sought medical attention in the emergency room and an EKG and blood work were performed (results not reported) but was admitted to the hospital. At the time of the report, the patient had not recovered. No further information to report. There was not a product quality complaint involved. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Blood glucose increased, Convulsion, Pallor, Tremor, Unresponsive to stimuli
Clinical narrative: Information has been received from a woman in a physician's office concerning an 18-year-old male student who on 14-DEC-2006, at 1230, was vaccinated in the right deltoid with the second dose of Recombivax HB (Lot #655810/1022F) (1st dose noted to be given "years ago"). At the time of vaccination, the patient was noted to be depressed and had not eaten for approximately 24 hours as a friend had died the previous day. It was reported that on 14-DEC-2006, at 1245, the patient was brought back to the physician office after he had been shaking and unresponsive. The patient had a seizure at the office lasting for 30 seconds and was very pale. The physician and nurse monitored the patient's vitals (results not provided), blood sugar (116), had him lie down and gave him orange juice. It was noted that the patient would not receive any further doses of Recombivax HB. At the time of this report, the outcome was unknown. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Diarrhoea, Nausea, Vomiting
Clinical narrative: Information has been received fro a physician's assistant concerning a 24 year old female, with a penicillin allergy and no medical history, who on 03-JAN-2007 was vaccinated with a first 1 ml intramuscular dose of Recombivax HB (Lot# 653391/0186F). There was no concomitant medication. On 03-JAN-2007 about 45 minutes after vaccination with Recombivax, the patient developed nausea and abdominal cramping. The patient vomited twice and had diarrhea. No treatment was given. After several hours of rest the patient seemed to be recovering. There were no laboratory or diagnostic tests performed. Unspecified medial attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Crying, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning an 18-year-old female who in August 2006, was vaccinated with a 0.5 dose of Recombivax HB. Within 15 minutes of vaccination, the patient experienced nausea; and within another 15 to 30 minutes she had a fever and sweating; one hour later she experienced sharp stomach pains with crying lasting for four hours. Subsequently, the patient recovered from nausea, fever, sweating and sharp stomach pains, and crying. No diagnostic studies were performed. No additional information to report. There was not product quality complaint involved. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, Feeding disorder of infancy or early childhood, Insomnia, Intussusception, Pyrexia
Clinical narrative: Information has been received concerning a 2 month old male, with no allergies, who on 17-JAN-2007, at 1:30 p.m., was vaccinated with an oral first dose of Rotateq (lot #655153/0847F). Concomitant vaccines administered on the same day included a first intramuscular dose in the right leg of Prevnar (lot #B08672F), a first intramuscular dose in the left leg of ActHib (lot # UE915AA) and a first intramuscular dose in the right leg of Pediarix (lot AC21B065AA). On 20-FEB-2007, the patient's mother took the patient to the clinic at 2:00 p.m. complaining that the child would not sleep, would not eat anything, and was crying since 3:30 a.m. The patient vomited four times at home and one in the clinic. The patient had a fever and was sent to the hospital where he was diagnosed with intussusception. Subsequently the patient recovered. Upon internal review, the patient's intussusception was considered to be other important medical event. A lot check was requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements and was released. Additional information has been requested.03/22/07-records received DOS 02/20/2007-DX Intussusception right upper quadrant of abdomen by ultrasound. tranferred to another facility 05/15/07-records received from receiving facility for DOS 02/21-02/22/07-DC DX: Intussusception. Air enema reduction. Successful reduction of ileocolic intussusception by air enema.  PE generalized tenderness and discomfort with abdominal palpation. Vomiting and irritability times 1 day. Bloody soft stool. Guaic positive. Fever 100.8.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received concerning a 2 month old male, with no allergies, who on 17-JAN-2007, at 1:30 p.m., was vaccinated with an oral first dose of Rotateq (lot #655153/0847F). Concomitant vaccines administered on the same day included a first intramuscular dose in the right leg of Prevnar (lot #B08672F), a first intramuscular dose in the left leg of ActHib (lot # UE915AA) and a first intramuscular dose in the right leg of Pediarix (lot AC21B065AA). On 20-FEB-2007, the patient's mother took the patient to the clinic at 2:00 p.m. complaining that the child would not sleep, would not eat anything, and was crying since 3:30 a.m. The patient vomited four times at home and one in the clinic. The patient had a fever and was sent to the hospital where he was diagnosed with intussusception. Subsequently the patient recovered. Upon internal review, the patient's intussusception was considered to be other important medical event. A lot check was requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements and was released. Additional information has been requested.03/22/07-records received DOS 02/20/2007-DX Intussusception right upper quadrant of abdomen by ultrasound. tranferred to another facility 05/15/07-records received from receiving facility for DOS 02/21-02/22/07-DC DX: Intussusception. Air enema reduction. Successful reduction of ileocolic intussusception by air enema.  PE generalized tenderness and discomfort with abdominal palpation. Vomiting and irritability times 1 day. Bloody soft stool. Guaic positive. Fever 100.8.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Anorexia, Crying, Insomnia, Intussusception, Pyrexia
Clinical narrative: Information has been received concerning a 2 month old male, with no allergies, who on 17-JAN-2007, at 1:30 p.m., was vaccinated with an oral first dose of Rotateq (lot #655153/0847F). Concomitant vaccines administered on the same day included a first intramuscular dose in the right leg of Prevnar (lot #B08672F), a first intramuscular dose in the left leg of ActHib (lot # UE915AA) and a first intramuscular dose in the right leg of Pediarix (lot AC21B065AA). On 20-FEB-2007, the patient's mother took the patient to the clinic at 2:00 p.m. complaining that the child would not sleep, would not eat anything, and was crying since 3:30 a.m. The patient vomited four times at home and one in the clinic. The patient had a fever and was sent to the hospital where he was diagnosed with intussusception. Subsequently the patient recovered. Upon internal review, the patient's intussusception was considered to be other important medical event. A lot check was requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements and was released. Additional information has been requested.03/22/07-records received DOS 02/20/2007-DX Intussusception right upper quadrant of abdomen by ultrasound. tranferred to another facility 05/15/07-records received from receiving facility for DOS 02/21-02/22/07-DC DX: Intussusception. Air enema reduction. Successful reduction of ileocolic intussusception by air enema.  PE generalized tenderness and discomfort with abdominal palpation. Vomiting and irritability times 1 day. Bloody soft stool. Guaic positive. Fever 100.8.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Blood glucose normal, CSF test normal, Chest X-ray normal, Full blood count normal, Headache
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 15 year old female patient with asthma who on 28-FEB-2007 was vaccinated with a dose of Gardasil, lot #654535/0960F. Concomitant suspect therapy included Menactra, administered on the same day. Other concomitant therapy included Advair. On 05-MAR-2007 the patient was diagnosed with Guillain-Barre syndrome. Her outcome was not reported. The reporter felt that Guillain Barre syndrome was a result of Menactra, and not Gardasil. Upon internal review, Guillain-Barre syndrome was considered to be an other important medical event. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Hypoaesthesia, Hypokinesia, Hyporeflexia, Malaise, Pyrexia
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 15 year old female patient with asthma who on 28-FEB-2007 was vaccinated with a dose of Gardasil, lot #654535/0960F. Concomitant suspect therapy included Menactra, administered on the same day. Other concomitant therapy included Advair. On 05-MAR-2007 the patient was diagnosed with Guillain-Barre syndrome. Her outcome was not reported. The reporter felt that Guillain Barre syndrome was a result of Menactra, and not Gardasil. Upon internal review, Guillain-Barre syndrome was considered to be an other important medical event. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Tremor, Urine analysis normal, Vomiting
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 15 year old female patient with asthma who on 28-FEB-2007 was vaccinated with a dose of Gardasil, lot #654535/0960F. Concomitant suspect therapy included Menactra, administered on the same day. Other concomitant therapy included Advair. On 05-MAR-2007 the patient was diagnosed with Guillain-Barre syndrome. Her outcome was not reported. The reporter felt that Guillain Barre syndrome was a result of Menactra, and not Gardasil. Upon internal review, Guillain-Barre syndrome was considered to be an other important medical event. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Guillain-Barre syndrome
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 15 year old female patient with asthma who on 28-FEB-2007 was vaccinated with a dose of Gardasil, lot #654535/0960F. Concomitant suspect therapy included Menactra, administered on the same day. Other concomitant therapy included Advair. On 05-MAR-2007 the patient was diagnosed with Guillain-Barre syndrome. Her outcome was not reported. The reporter felt that Guillain Barre syndrome was a result of Menactra, and not Gardasil. Upon internal review, Guillain-Barre syndrome was considered to be an other important medical event. Additional information has been requested.
Age: 40.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Arthralgia, Joint swelling, Oedema peripheral, Pain in extremity, Rash
Clinical narrative: Information has been received from a physician concerning a 40-year-old male with hypertension and seasonal allergies with no previous drug reaction who on 04-NOV-2006 was vaccinated with MMR II (Lot #650102/0826R). Concomitant therapy included losartan potassium-HCTZ. On 27-NOV-2006, the patient experienced a pruritic macular rash evenly distributed over his body and joint pain. The outcome at the tiem of this report was not recovered, no information if there has been any improvement. Medical attention was sought. Complete blood count results showed an elevated white blood cell count. The patient has been examined by a dermatologist, and an appointment with a hematologist was pending at the time of report. The patient's pruritic rash and macular rash and joint pain were considered to be disabling. Additional information has been requested.
Age: 40.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Arthralgia, Full blood count abnormal, Rash macular, Rash pruritic, White blood cell count increased
Clinical narrative: Information has been received from a physician concerning a 40-year-old male with hypertension and seasonal allergies with no previous drug reaction who on 04-NOV-2006 was vaccinated with MMR II (Lot #650102/0826R). Concomitant therapy included losartan potassium-HCTZ. On 27-NOV-2006, the patient experienced a pruritic macular rash evenly distributed over his body and joint pain. The outcome at the tiem of this report was not recovered, no information if there has been any improvement. Medical attention was sought. Complete blood count results showed an elevated white blood cell count. The patient has been examined by a dermatologist, and an appointment with a hematologist was pending at the time of report. The patient's pruritic rash and macular rash and joint pain were considered to be disabling. Additional information has been requested.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Cyanosis, Dysphagia, Hospitalisation, Infantile apnoeic attack
Clinical narrative: Information has been received from a health professional concerning a 9 week old female, who was a twin, born at 32 weeks, with severe reflux, who on 02-JAN-2007 was vaccinated with a first oral dose of Rotateq. Concomitant vaccines administered on the same day included a dose of Pediarix, a dose of PedvaxHIB (manufacturer unknown) and a dose of Prevnar. It was reported that, on 02-JAN-2007, the patient had trouble swallowing the vaccine and her lips turned slightly blue. That night her apnea alarm went off and she was admitted to the hospital. The length of hospitalization was unknown. Subsequently the patient recovered. The reporter noted that the patient's twin did not have any trouble. No product quality complaint was involved. The patient's experiences were considered to be immediately life-threatening by the reporter. Additional information has been requested.
Age: 0.51
Sex: F
Vaccine: RV5
Symptoms: Enema administration, Intestinal resection, Intussusception, Surgery
Clinical narrative: Information has been received from a physician concerning a 6 month old female who on 31-JAN-2007 was vaccinated with her last dose of Rotateq (lot #654970/0777F) (the dated of the other two doses were not reported). The patient had no medical history or concomitant therapy. On 27-FEB-2007, the patient was examined by the physician and had developed intussusception. The patient's symptoms at the time of the exam were reported as unknown. On 01-MAR-2007, the patient was hospitalized for intussusception. An enema reduction was attempted unsuccessfully. The patient had bowel resection surgery. On an unspecified date, the patient recovered from intussusception. Her release date from the hospital was not known. The physician considered intussusception to be immediately life-threatening, and disabling, and an other important medical event. There was no product quality complaint involved. Additional information has been requested.  4/13/07 Received medical records & vax records from PCP which reveal child was in good health on day of vax 1/31/07.  Growth & development were as expected for age.  Lot # for 3rd dose of Rotateq incorrect on VAERS report & corrected in database. 4/27/07 Received medical records from hospital which reveal patient experienced bilious vomiting, lethargy, fever & dehydration x 2 days prior to admit on 3/1/07-3/5/07. Exam revealed tachycardia, decreased bowel sounds & guarding.  Rad attempts at reducing IS were unsuccessful & taken to OR for exp lap, reduction of IS & small bowel resection w/primary anastomosis.  Developed post op ileus which resolved.  Slowed advanced diet & had maroon stools initially.  D/c to home. FINAL DX: ileoileal intussusception, surgically reduced & small bowel resection.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Urine human chorionic gonadotropin negative
Clinical narrative: Information has been received from a 20 year old female with an allergy to Zomig and a history of multiple miscarriages. On 11-JAN-2007 the patient was vaccinated with her first dose of Gardasil when she was 4 and a half weeks pregnant. The patient took a urine Human chorionic gonadotropin (HCG) test in the doctor's office that said she was not pregnant, and they administered the vaccination on day. On 17-JAN-2007 the patient discovered she was pregnant. On 21-JAN-2007 she had a miscarriage. Medical attention was sought. Her outcome was unknown. Upon internal review, miscarriage was considered to be an other important medical event. Additional information has been requested. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Hip arthroplasty
Clinical narrative: Information has been received from a female who on 29-NOV-2006 was vaccinated with Gardasil. At the time of reporting, the patient had not yet received her second dose of Gardasil due to hip replacement surgery. Additional information has been requested. Upon internal review, hip replacement surgery was considered to be an other important medical event.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Information has been received from a medical assistant through a pregnancy registry concerning a 19 year old female with a history of miscarriage who was vaccinated with the first dose of Gardasil. It was reported that later the patient found out that she was pregnant. The patient was 2 months pregnant at the time of the vaccination. It was reported that the patient miscarried 2 weeks after the vaccination. At the time of the report it was unknown, if the patient recovered. Upon internal review, it was determined that miscarried was an other important medical event. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Autism spectrum disorder, Childhood disintegrative disorder, Hypokinesia, Nuclear magnetic resonance imaging, Rash
Clinical narrative: Information has been received from a consumer concerning her 15-month-old daughter with no drug reactions/allergies who on 11-JAN-2005 was vaccinated SC with a 0.5 mL dose of MMR II. There was no concomitant medication. On 13-JAN-2005 the patient stopped crawling or being active at all. She would not look at her mother and became unresponsive. Her daughter has since been diagnosed with pervasive developmental disorder (not otherwise specified). It was also noted that she had a rash on her leg that "just will not disappear". MRIs and sleep studies were obtained (results not reported). The outcome was not recovered. Unspecified medical attention was sought. There was no product quality complaint. Pervasive development disorder (not otherwise specified) was considered to be an other important medical event. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Sleep study, Unresponsive to stimuli
Clinical narrative: Information has been received from a consumer concerning her 15-month-old daughter with no drug reactions/allergies who on 11-JAN-2005 was vaccinated SC with a 0.5 mL dose of MMR II. There was no concomitant medication. On 13-JAN-2005 the patient stopped crawling or being active at all. She would not look at her mother and became unresponsive. Her daughter has since been diagnosed with pervasive developmental disorder (not otherwise specified). It was also noted that she had a rash on her leg that "just will not disappear". MRIs and sleep studies were obtained (results not reported). The outcome was not recovered. Unspecified medical attention was sought. There was no product quality complaint. Pervasive development disorder (not otherwise specified) was considered to be an other important medical event. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: FLU3, VARCEL, FLU3, VARCEL
Symptoms: Erythema, Eye swelling, Pruritus, Skin warm, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 7-year-old female with asthma and allergies to Zithromax, cyprohetador, beef, corn, soy, and milk, chronic gastric paresis, eosinophilic, and esophagitis who on 26-FEB-2007 at 4:30PM was vaccinated SC in the right arm with a second dose of Varivax (lot #656079/1306F). Concomitant therapy that day at 4:30PM included a forth dose of Fluzone (lot # U62271AA) administered in the right deltoid. Additional concomitant therapy included montelukas sodium, Flovent, Prevacid, Miralax and Vitamins (unspecified). On 26-FEB-2007 at 5:45PM, the patient's whole body became bright red, and the child became itchy and warm with hives. In additional, the patient's eyes started to swell. After talking to the doctor, 25mg Benadryl was given and was told to go to the ER. The patient began wheezing on the way to the ER. Epinephrine was given in the ER and the patient was discharged on prednisone. Subsequently, the patient recovered. There was no product quality complaint. The events were considered to be immediately life-threatening and other important medical events by the reporter. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: FLU3, VARCEL, FLU3, VARCEL
Symptoms: Wheezing
Clinical narrative: Information has been received from a registered nurse concerning a 7-year-old female with asthma and allergies to Zithromax, cyprohetador, beef, corn, soy, and milk, chronic gastric paresis, eosinophilic, and esophagitis who on 26-FEB-2007 at 4:30PM was vaccinated SC in the right arm with a second dose of Varivax (lot #656079/1306F). Concomitant therapy that day at 4:30PM included a forth dose of Fluzone (lot # U62271AA) administered in the right deltoid. Additional concomitant therapy included montelukas sodium, Flovent, Prevacid, Miralax and Vitamins (unspecified). On 26-FEB-2007 at 5:45PM, the patient's whole body became bright red, and the child became itchy and warm with hives. In additional, the patient's eyes started to swell. After talking to the doctor, 25mg Benadryl was given and was told to go to the ER. The patient began wheezing on the way to the ER. Epinephrine was given in the ER and the patient was discharged on prednisone. Subsequently, the patient recovered. There was no product quality complaint. The events were considered to be immediately life-threatening and other important medical events by the reporter. Additional information has been requested.
Age: 1.15
Sex: M
Vaccine: DTAPH, FLU3, MMRV, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: Fever & Seizure records received 5/3/07-notes received DX Febrile Seizure same day as vaccines. Temp 103.6 in ER. Shaking, eyes rolled questionable cyanosis
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: Nausea, lightheaded x 5 min right after injection.
Age: 1.5
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Erythema, Induration, Infection, Scab, Skin warm
Clinical narrative: R thigh redness, scab (infected) TX Augmentin 200/5 ml warm induration
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Back pain, Discomfort, Dizziness, Headache, Nystagmus
Clinical narrative: 1:30 Backache, headache, dizziness, generalized discomfort in clinic - call to facility for clarification of side effects, referred to Family Practice - developed stridor, nystagmus - transferred to facility reported at 4:30. Admitted to ICU. Discharged facility 3/9/07. 04/02/07-records received from facility-Fever and altered neurological status. Temp 101.2. Fell at clinic. Fainted. Presented to ER with nystagmus with mainly her gaze toward the right. Not speaking Hyperventilating. Fever a few days ago and had been sick with viral syndrome.  PE pupils equal round reactive to light but she had nystagmus frequently every few seconds and mainly seemed with a right. Required interpreter but she had no spontaneous speech. Carpal pedal spasm.  Summary for DOS 3/7-3/9/07. DC DX:Diseases disorders of nervous system. Convulsions, Tetany, bronchitis, nystagmus, altered mental status, hyperventilation, headache, lumbago, fever.  8/25/08-progress notes received-3/8/07 all symptoms have resolved discharged without any medications.  Continues to experience being a little dizzy when walking.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Stridor
Clinical narrative: 1:30 Backache, headache, dizziness, generalized discomfort in clinic - call to facility for clarification of side effects, referred to Family Practice - developed stridor, nystagmus - transferred to facility reported at 4:30. Admitted to ICU. Discharged facility 3/9/07. 04/02/07-records received from facility-Fever and altered neurological status. Temp 101.2. Fell at clinic. Fainted. Presented to ER with nystagmus with mainly her gaze toward the right. Not speaking Hyperventilating. Fever a few days ago and had been sick with viral syndrome.  PE pupils equal round reactive to light but she had nystagmus frequently every few seconds and mainly seemed with a right. Required interpreter but she had no spontaneous speech. Carpal pedal spasm.  Summary for DOS 3/7-3/9/07. DC DX:Diseases disorders of nervous system. Convulsions, Tetany, bronchitis, nystagmus, altered mental status, hyperventilation, headache, lumbago, fever.  8/25/08-progress notes received-3/8/07 all symptoms have resolved discharged without any medications.  Continues to experience being a little dizzy when walking.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Back pain, Bronchitis, CSF glucose normal, CSF protein normal, Convulsion
Clinical narrative: 1:30 Backache, headache, dizziness, generalized discomfort in clinic - call to facility for clarification of side effects, referred to Family Practice - developed stridor, nystagmus - transferred to facility reported at 4:30. Admitted to ICU. Discharged facility 3/9/07. 04/02/07-records received from facility-Fever and altered neurological status. Temp 101.2. Fell at clinic. Fainted. Presented to ER with nystagmus with mainly her gaze toward the right. Not speaking Hyperventilating. Fever a few days ago and had been sick with viral syndrome.  PE pupils equal round reactive to light but she had nystagmus frequently every few seconds and mainly seemed with a right. Required interpreter but she had no spontaneous speech. Carpal pedal spasm.  Summary for DOS 3/7-3/9/07. DC DX:Diseases disorders of nervous system. Convulsions, Tetany, bronchitis, nystagmus, altered mental status, hyperventilation, headache, lumbago, fever.  8/25/08-progress notes received-3/8/07 all symptoms have resolved discharged without any medications.  Continues to experience being a little dizzy when walking.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Discomfort, Dizziness, Electroencephalogram abnormal, Fall, Gaze palsy
Clinical narrative: 1:30 Backache, headache, dizziness, generalized discomfort in clinic - call to facility for clarification of side effects, referred to Family Practice - developed stridor, nystagmus - transferred to facility reported at 4:30. Admitted to ICU. Discharged facility 3/9/07. 04/02/07-records received from facility-Fever and altered neurological status. Temp 101.2. Fell at clinic. Fainted. Presented to ER with nystagmus with mainly her gaze toward the right. Not speaking Hyperventilating. Fever a few days ago and had been sick with viral syndrome.  PE pupils equal round reactive to light but she had nystagmus frequently every few seconds and mainly seemed with a right. Required interpreter but she had no spontaneous speech. Carpal pedal spasm.  Summary for DOS 3/7-3/9/07. DC DX:Diseases disorders of nervous system. Convulsions, Tetany, bronchitis, nystagmus, altered mental status, hyperventilation, headache, lumbago, fever.  8/25/08-progress notes received-3/8/07 all symptoms have resolved discharged without any medications.  Continues to experience being a little dizzy when walking.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Headache, Hyperventilation, Influenza serology negative, Lack of spontaneous speech, Lumbar puncture
Clinical narrative: 1:30 Backache, headache, dizziness, generalized discomfort in clinic - call to facility for clarification of side effects, referred to Family Practice - developed stridor, nystagmus - transferred to facility reported at 4:30. Admitted to ICU. Discharged facility 3/9/07. 04/02/07-records received from facility-Fever and altered neurological status. Temp 101.2. Fell at clinic. Fainted. Presented to ER with nystagmus with mainly her gaze toward the right. Not speaking Hyperventilating. Fever a few days ago and had been sick with viral syndrome.  PE pupils equal round reactive to light but she had nystagmus frequently every few seconds and mainly seemed with a right. Required interpreter but she had no spontaneous speech. Carpal pedal spasm.  Summary for DOS 3/7-3/9/07. DC DX:Diseases disorders of nervous system. Convulsions, Tetany, bronchitis, nystagmus, altered mental status, hyperventilation, headache, lumbago, fever.  8/25/08-progress notes received-3/8/07 all symptoms have resolved discharged without any medications.  Continues to experience being a little dizzy when walking.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Mental status changes, Nervous system disorder, Neurological symptom, Neutrophil count increased, Nystagmus
Clinical narrative: 1:30 Backache, headache, dizziness, generalized discomfort in clinic - call to facility for clarification of side effects, referred to Family Practice - developed stridor, nystagmus - transferred to facility reported at 4:30. Admitted to ICU. Discharged facility 3/9/07. 04/02/07-records received from facility-Fever and altered neurological status. Temp 101.2. Fell at clinic. Fainted. Presented to ER with nystagmus with mainly her gaze toward the right. Not speaking Hyperventilating. Fever a few days ago and had been sick with viral syndrome.  PE pupils equal round reactive to light but she had nystagmus frequently every few seconds and mainly seemed with a right. Required interpreter but she had no spontaneous speech. Carpal pedal spasm.  Summary for DOS 3/7-3/9/07. DC DX:Diseases disorders of nervous system. Convulsions, Tetany, bronchitis, nystagmus, altered mental status, hyperventilation, headache, lumbago, fever.  8/25/08-progress notes received-3/8/07 all symptoms have resolved discharged without any medications.  Continues to experience being a little dizzy when walking.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Pyrexia, Speech disorder, Stridor, Syncope, Tetany
Clinical narrative: 1:30 Backache, headache, dizziness, generalized discomfort in clinic - call to facility for clarification of side effects, referred to Family Practice - developed stridor, nystagmus - transferred to facility reported at 4:30. Admitted to ICU. Discharged facility 3/9/07. 04/02/07-records received from facility-Fever and altered neurological status. Temp 101.2. Fell at clinic. Fainted. Presented to ER with nystagmus with mainly her gaze toward the right. Not speaking Hyperventilating. Fever a few days ago and had been sick with viral syndrome.  PE pupils equal round reactive to light but she had nystagmus frequently every few seconds and mainly seemed with a right. Required interpreter but she had no spontaneous speech. Carpal pedal spasm.  Summary for DOS 3/7-3/9/07. DC DX:Diseases disorders of nervous system. Convulsions, Tetany, bronchitis, nystagmus, altered mental status, hyperventilation, headache, lumbago, fever.  8/25/08-progress notes received-3/8/07 all symptoms have resolved discharged without any medications.  Continues to experience being a little dizzy when walking.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Viral infection, White blood cell count increased
Clinical narrative: 1:30 Backache, headache, dizziness, generalized discomfort in clinic - call to facility for clarification of side effects, referred to Family Practice - developed stridor, nystagmus - transferred to facility reported at 4:30. Admitted to ICU. Discharged facility 3/9/07. 04/02/07-records received from facility-Fever and altered neurological status. Temp 101.2. Fell at clinic. Fainted. Presented to ER with nystagmus with mainly her gaze toward the right. Not speaking Hyperventilating. Fever a few days ago and had been sick with viral syndrome.  PE pupils equal round reactive to light but she had nystagmus frequently every few seconds and mainly seemed with a right. Required interpreter but she had no spontaneous speech. Carpal pedal spasm.  Summary for DOS 3/7-3/9/07. DC DX:Diseases disorders of nervous system. Convulsions, Tetany, bronchitis, nystagmus, altered mental status, hyperventilation, headache, lumbago, fever.  8/25/08-progress notes received-3/8/07 all symptoms have resolved discharged without any medications.  Continues to experience being a little dizzy when walking.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Clinical narrative: 3/28/07 Per phone conversation w/reporter, patient developed hives within a few minutes of vaccine.  Treated in office and at home w/oral Benadryl.  Patient had complete recovery w/o difficulty.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Lightheaded then passed out for less than 10 seconds.
Age: 87.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Herpes zoster, Nausea
Clinical narrative: Vaccinated 3/12. 3/13-3/16 slight nausea, backache. 3/16 shingles on waist - right side appeared. Started Acyclovir 3/16.   Follow-up - Lot# 0163U exp. date 13/07/08
Age: 87.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Nausea
Clinical narrative: Vaccinated 3/12. 3/13-3/16 slight nausea, backache. 3/16 shingles on waist - right side appeared. Started Acyclovir 3/16.   Follow-up - Lot# 0163U exp. date 13/07/08
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy, Hypotrichosis, Laboratory test, Lichen planus, Rash
Clinical narrative: Rash on back, sides and arms - Dr incorrectly diagnosed as Pityriasis Rosea on 1-2-07. Diagnosed as Lichen Planus 3-6-07. Recommended treatment drug Soriatan Acitretin which has possible severe side effects not being used at this time. This is in follow-up to report(s) previously submitted on 4/13/2007. Information has been received from a licensed practical nurse concerning a 69 year old male with benign prostatic hyperplasia, arteriosclerotic cardiovascular disease, osteoporosis, trigeminal neuralgia, hyperlipidaemia, dyspepsia, hypertension, and allergies to ANTACAND ("problem with is his head"), ACEON (lightheaded), ALTACE (vertigo), MAVIR (vertigo) PRAVACHOL (vertigo), and REMERON (sleep aberration) who on 14-DEC-2006, in the PM, was vaccinated with no improperly stored first dose of ZOSATAVAX (Merck) (lot # 654604/1406F). There was no illness at the time of vaccination. Concomitant therapy included AVODART, aspirin, LIPITOR, AMBIEN, TEGRETOL, SEPTRA DS, VIAGRA and clobetasol propionate. The patient developed a non-vesicular rash on his back 10 days after receiving the vaccination. The patient was referred to a dermatologist who first diagnosed pityriasis rosea and then dermined the diagnosis to be lichen planus. The patient was prescribed SORIATANE. The patient also had a decrease in facial hair. At the time of the report, the patient had not recovered. A product quality complaint was not involved.  Additional information was received from the licensed practical nurse who reported that on 17-DEC-2006, the patient developed a rash on his back, he had facial hair loss, and lichen planus. It was noted that the patient was also recently started on AVODART. The patient saw a dermatologist. The patient was found to have benign nevi (no treatment needed), lentigines/ephelides (not treatment needed), and lichen planus for which he was treated with SORIATANE 29 mg daily. The dermatologist made no comment regarding whether the lichens planus was related to vaccination with ZOSTAVAX (Merck). It was unknown if the patient recovered. No further information is expected.