chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Papilloma viral infection, Smear cervix abnormal, Vomiting
Clinical narrative: Information has been received from a 26 year old female Registered Nurse with a history of abnormal Papanicolaou smear in 2003 who in approximately June 2007, was vaccinated IM with the first dose of Gardasil.  The patient was vaccinated with the second dose of Gardasil in August 2007 and the received the third dose in January 2008.  There was no concomitant medication.  Subsequently the patient tested positive for HPV.  The patient also reporting becoming nauseous and had vomiting for about 48 hours after receiving the second dose.  The patient recovered from the nausea and vomiting without treatment.  Additional information has been requested. Follow up information was received. The reporter does not know who administered the vaccine. It was reported that on 01-FEB-2008, the patient had a negative pap test and a positive test for HPV-HH. No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a medical assistant concerning a female with an allergy to BIAXIN, penicillin and erythromycin who on 04-SEP-2007 was vaccinated with the first dose of Gardasil.  The patient received the second dose of Gardasil on 27-NOV-2007 and subsequently experienced hives in a small area on the arm.  Subsequently, the patient recovered from the hives.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female with no reported medical history who on 09-NOV-2007 was vaccinated with 0.5 ml of Gardasil (Lot #659439/1267U) intramuscularly.  Concomitant therapy included MENACTRA (route and site of administration not reported) on the same day.  The patient fainted shortly after receiving the Gardasil shot.  The patient was observed for 60 minutes in the office following the fainting.  No further information was available.  The patient recovered on an unspecified day in November 2007.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy cervix abnormal, Cervical dysplasia, Colposcopy, Drug exposure during pregnancy, Genital haemorrhage
Clinical narrative: Initial and follow up information has been received from a nurse, via the Merck pregnancy registry, concerning a 22 year old female patient, non-smoker with exercise-induced mild asthma (since age 12, no medication), human papilloma virus, and a history of frequent urinary tract infection post-coital, who on 05-FEB-2007 was vaccinated with the first dose, 0.5 ml, of GARDASIL (lot #654510/0962F), and on 17-APR-2007 with the second dose, 0.5 ml, of GARDASIL (lot #654702/0011U). On 07-MAY-2007, the patient had a blood test which confirmed she was pregnant. Date of the LMP and estimated date of conception and delivery were not provided. During pregnancy, the patient took prenatal vitamins PRIMACARE ONE). On 12-JUN-2007, the patient had a Papanicolaou (PAP) test, that revealed atypical squamous cells of undetermined significance (ASCUS), cannot rule out HOSIL (high grade squamous intraepithelial lesion). On 02-JUL-2007 the patient experienced spotting. On 03-JUL-2007, the patient visited the physician was diagnosed with a small subchorionic hemorrhage; an ultrasound indicated she was at 12 weeks, 6 days gestation, with estimated date of confinement of 09-JAN-2008. On 09-JUL-2007, she had an pap smear result of ASCUS, with 2 lesions (Reid's index score 1 lesion at 12, score 2 at 5-6 without Lugol's). A colposcopy was performed, and a biopsy showed cervical intraepithelial neoplasm (CIN) grade 2. On 15-AUG-2007, an ultrasound indicated she was at 18 weeks, 3 days gestation. On 22-OCT-2007, a repeat colposcopy revealed a small focal area 5 o'clock, 3 mm focal area of HPV (right upper inner labia minora). On 05-DEC-2007, the patient was found to be streptococcus B positive, with a note to "treat in labor." On 16-JAN-2008, the patient, with continued CIN II, had a normal spontaneous vaginal delivery, at full-term gestation, and delivered an 8 lb 8 oz, female infant (no complications or abnormalities noted). Beginning after delivery, she experienced "significant symphysitis." In late January 2009 (noted in obstetrician's notes on 01-FEB-2008 as "several days ago"), the patient saw her primary care physician for treatment of a fever up to 104 degrees, which was attributed to flu symptoms; on 01-FEB-2008, she had a normal post partum exam with only some residual symphysis discomfort to palpation. ON 25-FEB-2008, at 6 weeks post partum, the patient had a benign post partum exam, with no complaints and no gross HPV lesions. Additional information is not expected. Follow up from the patient indicated that her baby was healthy and normal and was "doing fine." Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Haemorrhage, Pregnancy test positive, Smear cervix abnormal, Streptococcal identification test positive, Ultrasound scan
Clinical narrative: Initial and follow up information has been received from a nurse, via the Merck pregnancy registry, concerning a 22 year old female patient, non-smoker with exercise-induced mild asthma (since age 12, no medication), human papilloma virus, and a history of frequent urinary tract infection post-coital, who on 05-FEB-2007 was vaccinated with the first dose, 0.5 ml, of GARDASIL (lot #654510/0962F), and on 17-APR-2007 with the second dose, 0.5 ml, of GARDASIL (lot #654702/0011U). On 07-MAY-2007, the patient had a blood test which confirmed she was pregnant. Date of the LMP and estimated date of conception and delivery were not provided. During pregnancy, the patient took prenatal vitamins PRIMACARE ONE). On 12-JUN-2007, the patient had a Papanicolaou (PAP) test, that revealed atypical squamous cells of undetermined significance (ASCUS), cannot rule out HOSIL (high grade squamous intraepithelial lesion). On 02-JUL-2007 the patient experienced spotting. On 03-JUL-2007, the patient visited the physician was diagnosed with a small subchorionic hemorrhage; an ultrasound indicated she was at 12 weeks, 6 days gestation, with estimated date of confinement of 09-JAN-2008. On 09-JUL-2007, she had an pap smear result of ASCUS, with 2 lesions (Reid's index score 1 lesion at 12, score 2 at 5-6 without Lugol's). A colposcopy was performed, and a biopsy showed cervical intraepithelial neoplasm (CIN) grade 2. On 15-AUG-2007, an ultrasound indicated she was at 18 weeks, 3 days gestation. On 22-OCT-2007, a repeat colposcopy revealed a small focal area 5 o'clock, 3 mm focal area of HPV (right upper inner labia minora). On 05-DEC-2007, the patient was found to be streptococcus B positive, with a note to "treat in labor." On 16-JAN-2008, the patient, with continued CIN II, had a normal spontaneous vaginal delivery, at full-term gestation, and delivered an 8 lb 8 oz, female infant (no complications or abnormalities noted). Beginning after delivery, she experienced "significant symphysitis." In late January 2009 (noted in obstetrician's notes on 01-FEB-2008 as "several days ago"), the patient saw her primary care physician for treatment of a fever up to 104 degrees, which was attributed to flu symptoms; on 01-FEB-2008, she had a normal post partum exam with only some residual symphysis discomfort to palpation. ON 25-FEB-2008, at 6 weeks post partum, the patient had a benign post partum exam, with no complaints and no gross HPV lesions. Additional information is not expected. Follow up from the patient indicated that her baby was healthy and normal and was "doing fine." Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Drug exposure during pregnancy, Papilloma viral infection, Premature labour, Ultrasound scan normal
Clinical narrative: Information has been received from a nurse and medical records through the pregnancy registry for Gardasil concerning a 15 year old female with an environmental allergy and migraines, a history of UTI, and an otherwise unremarkable medical history, who on 30-MAR-2007 was vaccinated intramuscularly in the left arm with the first dose of Gardasil (0.5 ml) (lot # 654535/0960F). Concomitant therapy included CLARITIN and PERIACTIN. It was reported that the patient's pediatrician was notified by an OB/GYN's office that the patient was pregnant. The patient's LMP was 17-MAR-2007 (also reported as 24-JUL-2007). This was the patient's first pregnancy. An ultrasound on 07-AUG-2007 showed 33 weeks gestation. The patient did not seek treatment with the OB/GYN until she presented with increasing labor pains and gush of clear fluid. The loss of fluid occurred at 08:45 and shortly her contractions markedly increased in strength. When she presented, she was 4 to 5 cm and was managed expectantly. She was noted to be completely dilated at 1413 hours and the baby delivered in the right occiput anterior position at 1520. Nasal and oropharynx were suctioned in the perineum and gentle posterior traction was applied to the head to deliver the anterior shoulder. Once both shoulders were out, the patient reached down and delivered the remainder of the baby on her own. It was reported that the baby had a short cord and when elevated above the perineum approximately 8 inches, the cord broke after having very little traction applied to it. The point where the break occurred was approximately 1 inch away from the umbilicus of the baby which was grabbed  by the physician and pressure was applied. A Kelly clamp was applied to the area and therein stopped further bleeding. Overall blood loss was approximately 50 cc. The placenta was expressed and noted to have a three-vessel cord and was intact. Inspection of the perineum noted second-degree perineal lacerations which were repaired in a standard fashion with 3.0 Vicryl suture. The patient delivered a full term normal baby girl weighing 7 pounds 8.4 ounces with a length of 19.9 inches, apgar 8/9 with no apparent problems. There were no congenital anomalies and no other complications or abnormalities. On 17-SEP-2007, the baby was examined and was noted to have marked moldings with a temperature of 99 degrees rectally. The patient (mother) was also reported to have had condylomula and a positive HPV test. The patient was discharged after delivery on 19-SEP-2007. No further information is expected. Pediatric medical records were received and reviewed; adverse experiences related to hepatitis B virus vaccine were identified, and are described in WAES # 0803USA04159.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Gonorrhoea, Laboratory test normal, Trichomoniasis, Ultrasound scan
Clinical narrative: Information has been received through the Merck pregnancy registry through an 18 year old female consumer who on 21-NOV-2007 was vaccinated intramuscularly with her first dose of Gardasil.  There was no concomitant medication.  Subsequently, the patient was determined to be 4 months pregnant (not further specified) (LMP approximately 15-AUG-2007).  The patient sought unspecified medical attention.  Follow-up information was received.  Concomitant therapy included prenatal vitamins ongoing for 1 tablet daily.  On an unspecified date the patient had an ultrasound and the results were twins 15 weeks.  A MSAFP Quad screen was 1.85 and was within normal limits.  In December 2007, diagnostic testing revealed that the patient had trichomoniasis and gonorrhea and was treated with FLAGYL and other unspecified therapy.  On 11-DEC-2007, the patient had heavy vaginal discharge.  The patient's LMP was 15-AUG-2007 and the estimated date of delivery is 21-MAY-2008.  Additional information has been requested. Follow-up information was received from the physician's office. On 08-MAR-2008 the patient delivered normal twin girls. Twin A was 3 lbs 5 oz and 32.2 weeks from LMP. The Apgar score was 9/9. Twin A also had routine prenatal labs "frequent US". Twin B was 3 lbs 13 oz and 32.2 weeks from LMP. The Apgar score was 8/9. Twin B was a preterm delivery and had premature rupture membranes. Twin B had decorded growth. Twin B also had routine prenatal labs "frequent US." The patient also had concomitant drug which included Celestone injections and "PROCARDIA" 10mg every 4 hours for pre-term labor. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Vaginal discharge
Clinical narrative: Information has been received through the Merck pregnancy registry through an 18 year old female consumer who on 21-NOV-2007 was vaccinated intramuscularly with her first dose of Gardasil.  There was no concomitant medication.  Subsequently, the patient was determined to be 4 months pregnant (not further specified) (LMP approximately 15-AUG-2007).  The patient sought unspecified medical attention.  Follow-up information was received.  Concomitant therapy included prenatal vitamins ongoing for 1 tablet daily.  On an unspecified date the patient had an ultrasound and the results were twins 15 weeks.  A MSAFP Quad screen was 1.85 and was within normal limits.  In December 2007, diagnostic testing revealed that the patient had trichomoniasis and gonorrhea and was treated with FLAGYL and other unspecified therapy.  On 11-DEC-2007, the patient had heavy vaginal discharge.  The patient's LMP was 15-AUG-2007 and the estimated date of delivery is 21-MAY-2008.  Additional information has been requested. Follow-up information was received from the physician's office. On 08-MAR-2008 the patient delivered normal twin girls. Twin A was 3 lbs 5 oz and 32.2 weeks from LMP. The Apgar score was 9/9. Twin A also had routine prenatal labs "frequent US". Twin B was 3 lbs 13 oz and 32.2 weeks from LMP. The Apgar score was 8/9. Twin B was a preterm delivery and had premature rupture membranes. Twin B had decorded growth. Twin B also had routine prenatal labs "frequent US." The patient also had concomitant drug which included Celestone injections and "PROCARDIA" 10mg every 4 hours for pre-term labor. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test positive, Vomiting
Clinical narrative: Information has been received from a certified medical assistant for the Pregnancy Registry for Gardasil with no pertinent medical history and no history of drug reactions/allergies concerning a 17 year old female who on 20-NOV-2007 was vaccinated with Gardasil (lot # 658282/1263U) 0.5 ml IM.  At the time of vaccination, the patient was at 12 weeks gestation as of 08-JAN-2008.  Her last menstrual period was on 15-OCT-2007.  The patient visited the office.  On an unspecified date, she had a positive pregnancy test (beta-human chorionic gonadotropin test (unspecified)).  Estimated date of delivery is 21-JUL-2008.  Additional information was received from the physician's assistant.  The patient's last menstrual period was in October 2007.  Her period was due on 08-NOV-2007.  On 20-NOV-2007, a pregnancy test was negative (same date as the vaccine injection).  On 20-NOV-2007, the patient was prescribed PHENERGAN 25 mg q6h for vomiting.  The patient (well child) was referred to an OB/GYN physician.  Additional information has been requested. 04/07/09 This is in follow-up to report(s) previously submitted on 4/7/2008; 7/8/2008. Follow up information was received from a health care worker in physician's office by phone call. It was reported that the patient's delivery was fine and as far as the reporter knew the baby was healthy and normal. The mom had just been in the office on 11-FEB-2009. The reporter did not indicate the reason for the recent visit. No further information was available.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Lymph node pain, Lymphadenopathy, Tenderness, White blood cell count
Clinical narrative: Information was obtained on request by the Company from the government via the Act concerning a 25 year old female with a history of molluscum contagiosum opposite side who on 08-JUN-2007 was vaccinated IM in the right upper out quadrant of the hip with a dose of Gardasil (lot # 657868/0523U). Concomitant therapy included LEVORA. On 13-JUN-2007 the patient was seen for painful swollen lymph nodes right inguinal area and tenderness from area of injection to lymph not. White blood cell count was not elevated. The patient's status was not reported. The original reporting source was not reported. The VAERS ID is 281914. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Injection site mass, Injection site rash
Clinical narrative: Information has been received from a health professional concerning a female with a history of morbid obesity who on 05-SEP-2007 was IM vaccinated with her first dose of Gardasil (lot number unspecified) in the left deltoid. On 26-DEC-2007 the patient received her second dose, previously reported as her first dose, of Gardasil (lot number unspecified) intramuscularly in the left hip. At an unspecified time, the patient returned to the office for the third injection, there was a palpable lump at the left hip injection site. The patient told the physician assistant that the lump was improved and had been much larger. The patient told the physician assistant that there had been an injection site rash at the left hip for an  unspecified period of time. On 26-Dec-2007 the patient experienced incorrect site, injection site rash and palpable lump at injection site. Additional information has been requested. Additional information received from the physician indicated the patient experienced the adverse events for approximately 1 month. The patient recovered from injection site rash and palpable lump on 24-Jan-2008.
Sex: F
Vaccine: HPV4
Symptoms: Accidental exposure, Medical device complication
Clinical narrative: Information has been received from a female healthcare professional who reports that she had a small amount of Gardasil spray into her eye because of a defective, third party plastic syringe. No symptoms were reported. The Service Request Number is 1-2360217272. Follow-up information received from NSC call (07-FEB-2008): Per the reporter, the Gardasil involved in this case was being administered to a patient. The patient received approximately 3/4 of the dose. No symptoms were reported. Names/initials of the patient were not provided. This was dose 3 for the patient. This situation occurred on 05-FEB-2008 and there are no other details. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Incorrect dose administered, Injection site pain
Clinical narrative: Information has been received from a consumer concerning her daughter who on 18-FEB-2008 was vaccinated with a fourth dose of GARDASIL (Lot # unknown) by mistake. In July 2007, in August 2007, and in January 2008 the patient was vaccinated with the first, second, and third dose of GARDASIL (Lot #'s unknown), respectively. The patient experienced pain at the injection site after each dose. The consumer reported that "the patient experienced no adverse side effects as a result of this." Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/7/2008.  Information has been received from a consumer concerning her daughter who on 18-FEB-2008 was vaccinated with a fourth dose of GARDASIL (Lot # unknown) by mistake.  In July, 2007, in August 2007 and in January 2008 the patient was vaccinated with the first, second, and third dose of GARDASIL (Lot #'s unknown), respectively.  The patient experienced pain at the injection site after each dose.  Follow-up information received from a registered nurse included that on 29-JUN-2007, 11-SEP-2007, 02-JAN-2008, and 18-FEB-2008 the patient was vaccinated with the first, second, third, and fourth dose of GARDASIL (Lot #'s unknown).  The nurse also reported all patients complain about pain at the injection site after every dose".  The nurse comfirmed that the statement "all patients complain about pain at the injection site after every dose: was a generalized statement that the injection site pain "is not considered and event".  She stated that they ahve read the literature and understand this is an expected reaction.  They have begun to explain this to patients when they come in for the injection and make certain they sit still for 15 minutes following the injection to avoid possible fainting.  As it is a general statement, the nurse reported that the doctor would not be providing any specifics patient details.  There will be no additional information coming in from the office concerning this event.  Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal X-ray, Abdominal rigidity, Dehydration, Diarrhoea, Full blood count normal
Clinical narrative: Information has been received from a registered nurse concerning her 16 year old daughter with a history of irritable bowel syndrome who on unspecified dates were vaccinated with a first and second dose of Gardasil. On 23-FEB-2008 the patient was vaccinated with a third dose of Gardasil 0.5 mL IM. There was no concomitant therapy. The registered nurse reported her daughter completed the Gardasil series on 23-FEB-2008. Since her daughter has started the vaccination series she developed intermittent abdominal spasms, nausea, vomiting and diarrhea. The symptoms were severe on 03-JAN-2008 and the daughter was taken to the ER. She was found to be dehydrated; was treated with IV fluids, and was then released. The patient had an abdominal X-ray performed and was negative. A complete blood cell count was performed and was normal. The patient was positive for dehydration. At the time of the report the patient was recovering. This report is one of two sources. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning her 16 year old daughter with a history of irritable bowel syndrome who on unspecified dates were vaccinated with a first and second dose of Gardasil. On 23-FEB-2008 the patient was vaccinated with a third dose of Gardasil 0.5 mL IM. There was no concomitant therapy. The registered nurse reported her daughter completed the Gardasil series on 23-FEB-2008. Since her daughter has started the vaccination series she developed intermittent abdominal spasms, nausea, vomiting and diarrhea. The symptoms were severe on 03-JAN-2008 and the daughter was taken to the ER. She was found to be dehydrated; was treated with IV fluids, and was then released. The patient had an abdominal X-ray performed and was negative. A complete blood cell count was performed and was normal. The patient was positive for dehydration. At the time of the report the patient was recovering. This report is one of two sources. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Dizziness, Dizziness, Dysstasia, Headache, Immediate post-injection reaction
Clinical narrative: Information has been received from a registered nurse concerning her 16 year old daughter with headaches who on an unspecified date was vaccinated with a second dose of GARDASIL. Concomitant therapy included influenza virus vaccine (unspecified) on an unspecified date. Subsequently 24 hours after receiving the second dose of GARDASIL the patient experienced dizziness that lead to a headache. Medical attention was sought. At the time of reporting the patient had recovered. No further information was provided. Additional information has been requested. 02/17/2010 Subsequently on 04-DEC-2007 at 8 AM, 12 hours after receiving the second dose of GARDASIL the patient experienced dizziness (severe-could not stand up) severe headache, lightheadedness, no nausea and no fever. Medical attention was sought. "Did not take to hospital-thought was a virus going around". On 07-DEC-2008 the patient had recovered. No further information was provided. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia
Clinical narrative: Information has been received from a 22 year old female patient who in May 2007, was vaccinated with a first 0.5 mL dose of Gardasil. On an unspecified date in 2007, she was vaccinated with a second dose and in November 2007, she was vaccinated with her third dose of Gardasil. There was no concomitant medication. In June 2007, the patient experienced joint pain that first occurred in her upper shoulder then spread to her wrist, hip and knees. She reported that joint pain occurred since a month after the first dose of Gardasil and was still occurring. Additional information is not available.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Eye swelling, Nasopharyngitis
Clinical narrative: Information has been received from a nurse concerning a female who on 27-FEB-2008 was vaccinated IM with the first dose of GARDASIL. Subsequently the patient experienced swelling around one of her eyes a few days after receiving the vaccination. The patients' outcome was not reported. Additional information has been requested. 07/08/08 This is a follow-up to report(s) previously submitted on 4/7/2008. Information has been received from a nurse concerning a 13 year old female student who on 27-FEB-2008 was vaccinated (2:40PM) IM in her left arm with a first dose of GARDASIL (lot# 655327/1287U). On 03-MAR-2008 (10:00AM) the patient experienced puffy eyes and also had cold symptoms, BENADRYL was recommended. The patient's outcome was not reported. No further complications reported. Patient was not brought to the office. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hypotension
Clinical narrative: Information has been received from a 23 year old female who on 15-FEB-2007 was vaccinated with the first dose of GARDASIL. Concomitant therapy included MICROGESTIN. As soon as she received the vaccination, the patient became very dizzy and her blood pressure became very low. The patient continued experiencing dizzy spells that came on all of a sudden for approximately 6 months post vaccination. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on 02-MAR-2008 was vaccinated with her first dose of GARDASIL (lot number unspecified). On 02-MAR-2008 the patient experienced hives. The patient sought unspecified medical attention. No further information was provided. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a pharmacist concerning his 11 week old son with no pertinent medical history, drug reactions or allergies who on 05-FEB-2008 was vaccinated orally with a a "single dose" of ROTATEQ. There was no concomitant medication. The pharmacist reported that the patient had been experiencing 5-6 loose stools per day since 21-FEB-2008, 16 days after receiving his first dose of ROTATEQ. On 29 FEB 2008 the pharmacist contacted the physician by phones, who recommended switching the patient to a lactose free infant formula. The patient started the lactose free formula on 02 MAR 2008. At the time of reporting the patient had not yet recovered, and his symptoms were unchanged. No lab diagnostic studies were performed. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 07-NOV-2007 and 04-MAR-2008 was vaccinated PO with the first and second doses of ROTATEQ. The second dose was later than recommended. No adverse experience was related to this event. There was no product quality complaint. Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a 14 week old female who on 01-FEB-2008 was inadvertently vaccinated PO with her first dose of ROTATEQ (lot# 657986/1205U). The patient did not experience any difficulties since the first dose. The patient sought unspecified medical attention. There was no product quality complaint. Additional information has been requested.
Age: 0.1
Sex: F
Vaccine: HIBV, PNC, RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a registered nurse concerning a 43 day old female with no pertinent medical history or drug allergies who on 28-JAN-2008 was vaccinated PO with her first 2.0 ml dose of ROTATEQ (lot# 659688/1620U). Concomitant vaccinations administered on that same day included a dose of ACTHIB and a dose of PREVNAR. Shortly after vaccination the same day, the patient experienced diarrhea. The infant's mother called the physician's office on 31-JAN-2008 to mention that the diarrhea was continuing and the patient was then seen by the physician. The patient was treated with fluids, PEDIALYTE with weight monitoring and her formula was switched to DF, an infant formula. On 06-FEB-2008 the patient was seen in the office again for diarrhea that continued 10 days after vaccination. The patient was gradually reintroduced to her usual formula after the diarrhea resolved and she was recovered on 10-FEB-2008. There was no product quality complaint. Additional information has been requested.
Age: 0.53
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a 28 week old patient who on approximately 17-OCT-2007 and 06-MAR-2008 was vaccinated PO with the first and second doses of ROTATEQ. The patient sought medical attention via physician's office visit. The nurse mentioned that the patient had not experienced any difficulties since the first vaccination. There was no product quality complaint. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPH, IPV, PNC, RV5
Symptoms: Abnormal faeces, Dehydration, Diarrhoea, Vomiting
Clinical narrative: Information has been received from a physician concerning a male with a history of reflux and no drug allergies who on 14-NOV-2006, 13-DEC-2006 and 30-MAR-2007 was vaccinated PO with his first, second and third dose of ROTATEQ. On 26-FEB-2008 the patient experienced vomiting, diarrhea and his stool smelled like rotavirus. Since the patient experience vomiting and diarrhea, he was moderately dehydrated. The patient sought unspecified medical attention. No labs or diagnostic studies were performed. The child was noted to be fine and subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Abnormal faeces, Constipation, Mucous stools
Clinical narrative: Information has been received from a pharmacist concerning her son with no pertinent medical history or drug allergies who on 20-NOV-2007 and 21-JAN-2008 was vaccinated PO with his first and second doses of ROTATEQ. There was no concomitant medication. In 2007 after the patient's first dose, the patient's stools became "mucousy." Subsequently, the patient recovered from stools mucousy. In 2008 after the patient's second dose the patient became constipated with stool consistency of "peanut butter." It was also reported that the patient had not experienced any bleeding or discomfort with this change. The patient did begin to eat food between the first and second doses of ROTATEQ. The pharmacist contacted the physician for medical attention. No labs or diagnostic studies were performed. The patient was noted to be recovering at the time of this report. There was no product quality complaint. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a 6 month old male who on 15-NOV-2007 and 07-MAR-2008 was vaccinated PO with his first and second doses or ROTATEQ. No adverse reactions were reported. There was no product quality complaint. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: RV5, UNK
Symptoms: Diarrhoea, Vaccine positive rechallenge, Vomiting
Clinical narrative: Information has been received from a physician concerning an approximately 4 month old male with no pertinent medical history who on 27-NOV-2007 and 29-JAN-2008 was vaccinated PO with his first and second doses of ROTATEQ. Concomitant vaccinations included "other vaccines." After the first dose, the patient experienced severe vomiting and loose stools for two weeks. The patient eventually recovered. After the second dose, the patient experienced the same symptoms of severe vomiting and loose stools that lasted about two weeks as well. The patient sought unspecified medical attention. There was no product quality complaint. Therapy with ROTATEQ was discontinued after the second vaccination. Additional information has been requested.
Age: 0.1
Sex: U
Vaccine: RV5, UNK
Symptoms: Immediate post-injection reaction, Posturing
Clinical narrative: Information has been received from a nurse in a physician's office concerning a 6 week old patient who was vaccinated PO with the first single dose of Rotateq (no lot# provided).  Concomitant vaccinations administered on that same day were unspecified.  Almost immediately following administration of Rotateq, the patient experienced posturing.  The patient sought unspecified medical attention.  It was noted that the "patient was fine."  There was no product quality complaint.  Additional information has been requested.
Age: 0.52
Sex: F
Vaccine: RV5
Symptoms: Abnormal faeces, Diarrhoea, Diarrhoea, Inappropriate schedule of drug administration, Rotavirus infection
Clinical narrative: Information has been received from a nurse practitioner concerning a 9 month old female with no pertinent medical history or drug allergies who was vaccinated with a dose of Rotateq.  On 27-FEB-2008 the patient experienced the symptoms of rotavirus characterized by 13 loose stools per day which had a foul odor.  The patient was seen in the physician's office for medical attention.  No labs or diagnostic studies were performed.  The patient was treated with PEDIALYTE.  The patient still had loose stools but was noted to be recovering.  There was no product quality complaint.  Additional information has been requested. 06/02/2008 Follow-up information from the reporting nurse practitioner indicated that the 9 months old female who on 03-DEC-2007 was vaccinated PO with her third dose of ROTATEQ (lot# 657659/0969U). There was no illness at the time of vaccination. On 25-FEB-2008 the patient complained of loose, watery stools with 10 occurrences in one day on 27-FEB-2008. It was also reported that rotavirus was suspected. The outcome was unknown for watery stools. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Blood albumin decreased, Kawasaki's disease, Rash erythematous, Rash maculo-papular, Urine leukocyte esterase positive
Clinical narrative: Information has been received from a physician concerning a 4 month old male child whose mother was Caucasian and father was Asian who was vaccinated with rotavirus G1 G2 G3 G4 P1 reassortant vaccine live 2ml PO (human-bovine) at the age of two months. In June 2007, when the patient was 4 months of age he was hospitalized with Kawasaki disease which occurred in June 2007. The physician reported that after the hospitalization the child received the rest of the rotavirus G1 G2 G3 G4 P1 reassortant vaccine live series. The patient fully recovered from Kawasaki disease. 5/12/08-records received for DOS 6/4-6/8/07-DC DX: Kawasaki Disease. HX of fever times 6 days, on bactrim for urinary tract infection. HX of conjunctival injection, red rash, red lips. Treated with IVIG.Watery stools 04/30/08-records received for DOS 6/2-6/04/07-transferred to another facility for treatment of Kawasaki disease. Presented with 3-4 day history of fever as high as 104. Conjunctival injection, maculopapular rash, cracked red lips. Irritability. Further information has been received concerning this male child with an allergy to BACTRIM who on 27-APR-2007 was vaccinated with ROTATEQ ( lot # 656382/0234U) first dose. Other suspect vaccines included COMVAX ( lot #655550/1416F) IM, first dose. Other concomitant vaccine included DTaP (unspecified) + RECOMBIVAX HB + Hib conj vaccine PREVENAR (Lot # B08690C) IM and IPOL (lot # 20547-2) (all first dose). The physician reported that on 01-JUN-2007 the patient developed Kawasaki disease approximately 5 weeks after the two month old vaccination including ROTATEQ). The patient was hospitalized for about four days. The physician reported that the patient recovered. Additional information is not expected.
Age: 0.19
Sex: M
Vaccine: DTAP, HEP, IPV, PNC, RV5
Symptoms: Conjunctivitis, Echocardiogram normal, Kawasaki's disease, Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning a 14 week old male who on 08-JAN-2008 was vaccinated PO with a 2.0 ml dose of ROTATEQ (lot# 658383/1389U). Concomitant vaccinations administered on that same day included a dose of Hib conj vaccine (tet toxoid) (ACTHIB), a dose of PREVNAR, a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and a dose of poliovirus vaccine inactivated (unspecified). On 07-FEB-2008 the patient's fever started and this was when the physician felt was the onset of Kawasaki disease. Additional symptoms of Kawasaki's disease that the patient experienced included conjunctivitis and rash. On 08-FEB-2008 the patient was admitted to the hospital and was discharged on 11-FEB-2008. Subsequently, the patient recovered. The physician stated that "according to things I've read I don't think it was related to ROTATEQ." There was no product quality complaint. Additional information has been requested.  5/9/08 Reviewed hospital medical records for 2/8-2/11/2008. FINAL DX: Kawasaki disease Records reveal patient experienced fever, rash, cracked lips & red eyes, conjunctivitis, cough, runny nose, irritability, reduced oral intake x 1 week.  Cardio & ID consult done.  Tx w/IVIG & ASA.  Remained afebrile during hospitalization.  Improved & d/c to home on ASA w/cardio, ID & PCP f/u.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient who on approximately 28-JAN-2008 and 17-MAR-2008 was vaccinated PO with the first and second (lot# 658386/1734U) 2.0 ml doses of Rotateq at 19 weeks of age and at 27 weeks of age.  No adverse event was noted.  The patient sought medical attention in the physician's office.  There was no product quality complaint.  Additional information has been requested.
Age: 0.16
Sex: F
Vaccine: RV5
Symptoms: Underdose, Vomiting
Clinical narrative: Information has been received from a physician concerning a 2 month old female who on 17-MAR-2008 was vaccinated PO with her first dose of ROTATEQ (lot# 657667/1392U).  After vaccination the patient vomited almost the whole dose in the physician's office.  No symptoms were noted.  The patient recovered that same day.  There was no product quality complaint.  Additional information has been requested.
Age: 0.44
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 23 week old patient who on 20-DEC-2007 and 17-MAR-2008 was vaccinated PO with the first and second doses of ROTATEQ.  No problems were reported.  There was no product quality complaint.  Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning an infant who was vaccinated with the third dose (completed series) of Rotateq after the age of 12 months.  No symptoms were reported.  There was no product quality complaint.  This is one of several reports from the same source.
Sex: U
Vaccine: RV5
Symptoms: Rotavirus infection
Clinical narrative: Information has been received from a nurse concerning a patient who was vaccinated PO with a dose of Rotateq.  The patient experienced rotavirus infection 2 days after vaccination.  The patient was seen by a physician for medical attention.  The outcome was unknown.  There was no product quality complaint.  Additional information has been requested.  Follow-up information from a physician's office practice manager indicated that the office was not aware of this incident.  No further information is available.
Age: 0.3
Sex: F
Vaccine: RV5, UNK
Symptoms: Abdominal pain upper, Diarrhoea, Faeces discoloured
Clinical narrative: Information has been received from a physician concerning a 4 month old female who on 15-JAN-2008 was vaccinated PO with a 2.0 ml dose of Rotateq.  Concomitant vaccinations administered that same day included other "most common injectable vaccines used."  On that same day the patient experienced diarrhea (stool green in color) and stomach pains.  It was unknown whether medical attention was sought.  The patient's mother requested to discontinue therapy with Rotateq.  The outcome was unknown.  There was no product quality complaint.  Additional information has been requested.
Age: 0.55
Sex: F
Vaccine: RV5
Symptoms: Accidental exposure, Regurgitation, Underdose
Clinical narrative: Information has been received from a registered nurse concerning a female who on 20-MAR-2008 was vaccinated PO with her third 2.0 ml incomplete dose of ROTATEQ (lot# 659855/1692U). Upon administration the patient spit out the vaccine which then splashed into the child's right eye. The patient sought medical attention in the physician's office. The right was flushed with a saline eye wash. There was no product quality complaint. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/24/2008.  Follow-up information from the reporting registered nurse and administering register nurse concerning a 6 month old (14lb. 8oz. 25.25in.) female with no pre-existing medical conditions or allergies who on 20-MAR-2008 in the morning was vaccinated PO with her third dose of ROTATEQ (lot# 659855/1692U).  Upon administration the patient was able to spit it out and some went into her eye.  The eye ws irrigated with normal saline and more normal saline was given to the patien'ts dad for home.  No redness or irritation was noted.   The patient recovered on that same day.  Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Secondary transmission
Clinical narrative: Information has been received from a female nurse who reported that "every time she administers ROTATEQ she develops diarrhea. medical attention was not sought. The outcome was not reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: DTAP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning another physician's infant with no pertinent medical history who in approximately 2007 was vaccinated PO with the first and second doses of ROTATEQ. Concomitant vaccinations administered in approximately 2007 included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, a dose of PREVNAR and a dose of Hib conj vaccine (OMPC) (manufacturer unknown). In approximately 2007 the patient experienced diarrhea after the first dose of ROTATEQ. Subsequently the patient recovered. In approximately 2007 after the second dose, the patient experienced diarrhea. The infant sought unspecified medical attention. The father of the patient (physician), decided to discontinue therapy with ROTATEQ for the infant. Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Parenteral nutrition
Clinical narrative: Information has been received from a physician concerning an approximately 8-week-old infant who was vaccinated with a first oral dose of ROTATEQ.  It was reported that 20 hours after receiving the vaccination the patient developed severe diarrhea.  Medical attention was sought, and the child was hospitalized and required total parenteral nutrition.  At the time of the report, the diarrhea had not resolved.  No product quality complaint was involved.  The reporter considered diarrhea to be an other important medical event.  Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Immediate post-injection reaction, Regurgitation, Underdose
Clinical narrative: Information has been received from a physician concerning a 2 month old female who on 24-MAR-2008 was vaccinated with a 2 milliliter dose of Rotateq (Lot number: 659773/0020X) PO.  There was no concomitant medication.  The physician reported that the patient received Rotateq and immediately regurgitated the vaccine.  The patient regurgitated 2 ounces of milk and stomach contents along with the vaccine.  The patient sought medical attention in the office.  Outcome was not reported.  There was no product quality complaint.  Additional information has been requested.
Age: 0.8
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient who at 36 weeks of age, in approximately March of 2008, was vaccinated with a third dose of Rotateq.  No symptoms were reported.  There was no product quality complaint.  Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 2 month old male who 18-FEB-2008 was vaccinated orally with a first dose ROTATEQ (lot # 659685/1619U). Suspect therapy that same day included Hib conj vaccine (OMPC) (manufacturer unknown). Concomitant therapy included PEDIARIX, PREVNAR and ZANTAC. On 18-FEB-2008 the patient developed non stop vomiting 12 hrs post vaccination and was unable to keep anything down. The patient was taken to the hospital on 18 FEB 2008, at which time the patient was admitted, and treated with intravenous (unspecified). The patient was released from the hospital on 20 FEB 2008. At the time of reporting the patient was recovered (date unspecified). There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 5 day old patient who on 26-MAR-2008 was vaccinated with a dose of Rotateq.  No adverse experience was related to this event.  There was no product quality complaint.  Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Gastrooesophageal reflux disease
Clinical narrative: Information has been received from a physician concerning a 2 month old male who was vaccinated PO with his first dose of Rotateq.  Subsequently the patient experienced acid reflux.  The patient sought unspecified medical attention.  Therapy with Rotateq was discontinued.  The patient was treated with a medicine for acid reflux (unspecified).  The patient was noted to be recovering.  There was no product quality complaint.  Additional information has been requested.  This is one of several reports from the same source.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Gastrooesophageal reflux disease
Clinical narrative: Information has been received from a physician concerning a 2 month old female who was vaccinated PO with a dose of ROTATEQ. Subsequently the patient experienced acid reflux. It was unknown whether medical attention was sought. The patient was no treated with any medicine. Subsequently, the acid reflux went away and the patient was fully recovered. Additional information has been requested. This is one of several reports from the same source.