chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Blood test, Culture stool negative, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning a 4 month old male with no pertinent history and no drug allergies who was vaccinated PO with his second dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine). There was no concomitant medication. "About six weeks ago" the patient developed a 104 F fever, vomiting and diarrhea 7 days after administration. The vomiting and fever resolved after 3-4 days, but the diarrhea persisted. Medical attention was sought through an exam in the office. Lab diagnostic studies included a stool culture which showed negative for rotavirus and blood work. The patient was referred for a gastroenterology consult. The patient was treated with diet modification. The diarrhea was resolving at the time of this report. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a patient who has vaccinated with a dose of ROTATEQ vaccine live (human-bovine) (no lot numbers available). Subsequently the patient experienced diarrhea. Medical attention was sought at the physician's office. As a result, the parents of the patient requested the ROTATEQ vaccine live (human-bovine) series not to be continued. It was noted that by the physician that a "couple of patients out of hundred doses" at the office have experienced diarrhea. The recovery status was unknown. There was no product quality complaint. This is one of several reports from the same source. Additional information has been requested.
Age: 0.1
Sex: M
Vaccine: RV5
Symptoms: Flatulence
Clinical narrative: Information has been received from a physician concerning an approximately 60 day old male relative who "in the 2nd or 3rd week" of September 2007, received 2 ml oral dose of ROTATEQ vaccine live (human-bovine). In the 2nd or 3rd week of September 2007, 6 hours after receiving the vaccine the patient experienced a lot of gas. The patient sought unspecified medical attention. Subsequently, 48 hours after the dose, he recovered from a lot of gas. A product quality complaint was not reported. No further information was available. Additional information has been requested.
Age: 0.9
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Diarrhoea, Inappropriate schedule of drug administration, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 11 month old female with no pertinent medical history or drug allergies who on 06-APR-2007and 08-JUN-2007 was vaccinated PO with her first and second 2.0 mL doses of RotaTeq. On 04-OCT-2007, the patient was inadvertently vaccinated PO with the third 2.0 mL dose of RotaTeq (lot# 657520/0670U). Concomitant vaccinations administered that same day included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, a dose of ActHIB, a dose of Prevnar and a dose of poliovirus vaccine inactivated (unspecified). On 05-OCT-2007, the patient also developed diarrhea and fever. The patient sought medical attention by phone and in the physician's office. No labs or diagnostic studies were performed. The patient was not recovered 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: Vomiting
Clinical narrative: Information has been received from a certified medical assistant concerning a 6-month-old male with no medical history or allergies who on 06-AUG-2007 and 05-OCT-2007 (Lot #656845/0409U) was vaccinated PO with the first and second doses, respectively, of RotaTeq. There was no concomitant therapy. The CMA reported that on 05-OCT-2007, five minutes after receiving the second dose, the patient vomited. The patient was seen while still at the physician's office, recovered and was sent home. No laboratory/diagnostic tests were performed. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning an 18 week (reported as 4.5 months) old male who was vaccinated with ROTATEQ vaccine live (human-bovine). The physician reported that the patient experienced diarrhea a couple of days after receiving the second dose of ROTATEQ vaccine live (human-bovine) and it lasted for 6 to 7 weeks. Subsequently, the patient recovered. There was no product quality complaint. Additional information is not expected.
Age: 0.4
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning an approximately 5 month old male who "2 weeks ago", on approximately 25-SEP-2007, received his second dose early, only 2 weeks after the first dose of RotaTeq vaccine (lot# 656384/0237U). No adverse reactions were reported. A product quality complaint was not reported. No further information was available. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a physician concerning an 6 month old male who on 06-JUN-2007 and 06-AUG-2007 was vaccinated PO with his first (lot# 656388/0506U) and second (lot# 657292/0551U) doses of ROTATEQ vaccine live (human-bovine) at the 2 month and 4 month visit. The patient experienced diarrhea and vomiting for 7 days after administration of both doses. Medical attention was sought through the physician at the patient's 4 month visit. On 09-OCT-2007 for the 6 month visit, the physician decided not to administer the third dose of ROTATEQ vaccine live (human-bovine). No labs or diagnostic studies were performed. The patient was recovered 7 days after both vaccinations approximately 13-Jun-2007 and 13-AUG-2007 respectively. There was no product quality complaint. Additional information has been requested.
Age: 0.8
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a health professional concerning a 10 month old patient who in 2007 was vaccinated with a third dose of RotaTeq vaccine. The patient is late for the third dose of RotaTeq vaccine, but received the first two doses on time. No further information was available. It was unknown if medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 6 month old female who was vaccinated with a first dose of RotaTeq vaccine on a unspecified date. On 12-APR-2007, the patient was vaccinated with a second dose of RotaTeq vaccine. On 11-JUN-2007, the patient was vaccinated with a third dose of RotaTeq vaccine (lot# 657046/0504U). On 12-JUN-2007, the patient experienced bad diarrhea that was persistent for 2 or 3 days. Subsequently, the patient recovered 3 days after vaccination with the third dose of RotaTeq vaccine. It was reported that the patient's mother called the physician's office for medical attention. No product quality complaint was involved. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning an 8 month old male, with no medical history and no allergies, who was vaccinated with a first, second, and third oral dose of ROTATEQ vaccine live (human-bovine) on 15-MAR-2007, 21-MAY-2007 and 23-JUL-2007, respectively. There was no concomitant medication. The patient's parents reported to the physician that diarrhea started on 04-OCT-2007. On 09-OCT-2007, during an examination, there was a positive stool test for rotavirus. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with the first dose of RotaTeq vaccine (lot number not available). The physician reported that the patient subsequently developed diarrhea. Unspecified medical attention was sought. Subsequently, the patient recovered. It was noted that the patient did not receive the second or third dose of RotaTeq vaccine. Additional information has been requested.
Age: 0.1
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 2 month old patient who on 09-OCT-2007 and 10-OCT-2007 was vaccinated PO with 2.0 ml doses of ROTATEQ vaccine live (human-bovine). No adverse experience was related to this event. It was unknown whether medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a 4 month old female who on 10-OCT-2007 was vaccinated with the first dose of RotaTeq vaccine. No symptoms or problems were noted. It was unknown whether medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a licensed practical nurse concerning a 20 week old male who was vaccinated with his first dose of ROTATEQ vaccine live (human-bovine). Medical attention was sought in the physician's office. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of ROTATEQ vaccine live (human-bovine) (no lot numbers available). Subsequently the patient experienced diarrhea. Medical attention was sought at the physician's office. As a result, the parents of the patient requested the ROTATEQ vaccine live (human-bovine) series not to be continued. It was noted that by the physician that a "couple of patients out of hundred doses" at the office have experienced diarrhea. The recovery status was unknown. There was no product quality complaint. This is one of several reports from the same source. Additional information has been requested.
Age: 0.6
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning a 31 week old male who was vaccinated PO with his first, second and third doses of ROTATEQ vaccine live (human-bovine). The patient received the second dose 15 and 1/2 weeks after the first dose. No adverse reactions were reported. It was unknown whether medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 6 month old patient who on 16-MAY-2007 was vaccinated with RotaTeq vaccine. On 12-OCT-2007, the patient was seen by the physician to received the second dose of RotaTeq vaccine. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with ROTATEQ vaccine live (human-bovine) on the schedule of 4, 6, and 8 months of age. A product quality complaint was not reported. No other information was available. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a patient that received the first dose of RotaTeq vaccine at 16 weeks of age. No adverse reaction were reported. A product  quality complaint was not reported. No further information was available. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Faeces discoloured, Screaming
Clinical narrative: Information has been received from a physician concerning a 2 month old male who on 10-OCT-2007, was vaccinated with a first oral dose of ROTATEQ vaccine live (human-bovine) (lot#657517/0877U. It was reported that the patients mother had called the physician and informed him that the baby had developed persistent green diarrhea and was screaming as a result of the diarrhea. On 13-OCT-2007, the mother phoned the on-call physician and proceeded to an emergency department. It was reported that no diagnostic studies or labs were preformed. On 15-OCT-2007, the mother called the physicians office for follow and she reported that the patient was recovering. A product quality complaint was not reported. No further information was available. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a person working in a physician's office concerning a patient with gastroesophageal reflux disease, who on 12-OCT-2007 received an oral dose of RotaTeq vaccine and within hours developed diarrhea. As of this report, the diarrhea had not resolved. A product quality complaint was not reported. No Further information was available. Additional information has been requested.
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 male child who was vaccinated p.o. with a first 2 mL dose of RotaTeq vaccine after 12 weeks of age. No adverse affects. No other information. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested. This is one report of several from the same source.
Sex: F
Vaccine: RV5
Symptoms: Accidental exposure, Malaise
Clinical narrative: Information has been received from a female physician, who in 2007 ("about a couple of months ago" in 2007), after administering RotaTeq vaccine to one of her patients, believed she developed rotavirus. She reported that although she washed her hands, she thought that some residual vaccine from her hand was ingested during food consumption (sandwich). She reported that she was sick and stayed home for one week. Specific medical attention and current patient status was not reported. A product quality complaint was not reported. No further information was available. Additional information has been requested.
Age: 0.6
Sex: U
Vaccine: RV5
Symptoms: Gastroenteritis rotavirus
Clinical narrative: Information has been received from a physician concerning an 8 month old patient who received 3 doses, on schedule, of RotaTeq vaccine. It was reported that after completion of the vaccination series the patient developed severe rotavirus lasting for 2 weeks and has recovered. A product quality complaint was not reported. No further information was available. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 4 month old male who received a second 2.0 mL oral dose of RotaTeq vaccine. The physician reported that 3 days after receiving the vaccine the patient developed severe diarrhea. Unspecified medical attention was sought. It was reported that the patient has recovered. A product quality complaint was not reported. No further information was available.  Additional information is not expected.
Age: 0.3
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning a 16-week-old female with no medical history, who on 28-SEP-2007, at 10:30, was vaccinated PO with the first dose of RotaTeq vaccine (Lot #656707/0410U). There was no illness at the time of vaccination. The patient was seen in the physician's office. No adverse event was reported.  No further information is available.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning 5 patients who were over the age of 32 weeks up to 9 months of age when they were vaccinated with the third RotaTeq vaccine 2 mL oral. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: RV5, UNK
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 2 month old patient who on 13-APR-2007 was vaccinated PO with the first 2.0 ml dose of ROTATEQ vaccine live (human-bovine). Concomitant vaccinations administered "at the same time included other 2 month vaccinations." Subsequently the patient developed diarrhea for 10 days and was hospitalized. Subsequently, the patient recovered. There was no product quality complaint. This is one of several reports from the same source. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Crying, Diarrhoea, Irritability, Pain, Vomiting
Clinical narrative: Information has been received from a physician concerning a 11 week old male who on 01-OCT-2007 was vaccinated PO with his first 2.0 mL dose of RotaTeq vaccine. On 17-OCT-2007, the patient experienced pain, vomiting and loose stools and was cranky and crying. Unspecified medical attention was sought. Subsequently, the patient recovered. There was no product quality complaint. This is one of several reports from the same source. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5, UNK
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 4 month old patient, who on 14-AUG-2007 was vaccinated PO with the second 2.0 mL dose of RotaTeq vaccine. Concomitant vaccinations administered "at the same time included other 4 month vaccinations. " Subsequently the patient developed diarrhea for 10 days. It was unknown whether medical attention was sought. The outcome was unknown. There was no product quality complaint. This is one of several reports from the same source. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Crying, Diarrhoea, Irritability, Pain, Vomiting
Clinical narrative: Information has been received from a physician concerning a 2 month old female who on 08-OCT-2007 was vaccinated PO with her first 2.0 ml dose of ROTATEQ vaccine live (human-bovine). On 15-OCT-2007 the patient experienced pain, diarrhea and vomiting and was cranky and crying. Medical attention was sought in the physician's office. No labs or diagnostic studies were performed. Subsequently, the patient recovered. There was no product quality complaint. This is one of several reports from the same source. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 4-month-old male with no medical history or allergies who on 24-OCT-2007 was vaccinated PO with the second dose of ROTATEQ vaccine live (human-bovine). There was no concomitant therapy. The RN reported that on 27-OCT-2007, the patient vomited. The patient was seen in the physician's office. No laboratory/diagnostic tests were performed. On that same day, the patient recovered. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Rotavirus test positive
Clinical narrative: Information has been received from a healthcare worker concerning a 2 month old patient who was vaccinated with ROTATEQ vaccine live (human-bovine). It was reported that the next day the patient developed diarrhea that lasted about a week. It was reported that the patient's stools were positive for rotavirus. Medical treatment and current patient status was not reported. A product quality complaint was not reported. Additional information was not available. This is one of two reports from the same source. Additional information has been requested.
Age: 0.16
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concern a 2 month old patient who was vaccinated with a dose of RotaTeq vaccine. The next day the patient developed severe to moderately severe diarrhea for 8 days. It was unknown whether medical attention was sought. No medication was dispensed and there was no hospitalization. The baby was noted to be okay. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAP, FLUX, HIBV, PNC, RV5
Symptoms: Abnormal behaviour, Body temperature, Poor quality sleep, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her 6 month old nephew who on 26-OCT-2007 was vaccinated with a dose of ROTATEQ vaccine live (human-bovine). Other vaccinations received on the same day included influenza virus vaccine (unspecified), (manufacturer unknown), diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, (manufacturer unknown), Hib conj vaccine (OMPC) (manufacturer unknown), PREVNAR vaccine (CRM197). In the evening of 26-OCT-2007, it was reported that he was "just not acting right". He was awake several times throughout the night with fever (maximum temperature was 101.6 F). By 28-OCT-2007, he had recovered completely. No further information is available.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 6 month old female who "2 months ago", in August 2007, received her second oral dose of RotaTeq vaccine. It was reported that after receiving the dose she developed diarrhea and vomiting. It was reported that the patient sought unspecified medical attention and had recovered. No product quality complaint was reported. No other information was available. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: RV5
Symptoms: Abdominal pain, Diarrhoea, Inappropriate schedule of drug administration, Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning a 5 month old female with no pertinent medical history or drug allergies who on 02-AUG-2007 and 26-OCT-2007 was vaccinated PO with her first and second doses of RotaTeq vaccine (lot# 657045/1053U). There was no concomitant medication. On approximately 26-OCT-2007, the patient  experienced abdominal pain. On 26-OCT-2007 (Friday), the patient experienced diarrhea and vomiting for the next  two days (Saturday and Sunday). The patient was still experiencing abdominal pain. Unspecified medical attention was sought. No labs or diagnostic studies were performed. The outcome was not recovered. It was noted that the patient did not have the same adverse experience after the first dose. There was no product quality complaint. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 14 week old patient who on 26-JUL-2007 was vaccinated with ROTATEQ vaccine live (human-bovine) later than 13 weeks of age at another practice. It was reported that the patient's parents consulted with the physician. Current patient status was not reported. No product quality complaint was reported. No further information was available. Additional information has been requested.
Age: 0.16
Sex: F
Vaccine: RV5
Symptoms: Blood test, Body temperature increased, Diarrhoea, Pyrexia, Urine analysis
Clinical narrative: Information has been received from a physician concerning a 2 month old female who on 11-OCT-2007was vaccinated PO with her first 2.0 mL dose of RotaTeq vaccine. In 2007, the patient experienced a fever of 102.5 degrees Fahrenheit  and watery and frequent diarrhea. The patient was seen in the emergency room, but was not admitted to the hospital. Blood and urine studies were performed. Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.
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 male child who was vaccinated PO with a first 2 ml dose ROTATEQ vaccine live (human-bovine) after 12 weeks of age. No adverse affects. No other information. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event, Unevaluable event
Clinical narrative: Information has been received from a registered nurse concerning a male child who was vaccinated PO with a first 2 ml dose ROTATEQ vaccine live (human-bovine) after 12 weeks of age. No adverse affects. No other information. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested. This is one report of several from the same source.
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 male child who was vaccinated with a first 2 mL dose RotaTeq vaccine after 12 weeks of age. No adverse affects. No other information. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
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 male child who was vaccinated PO with a first 2 mL dose of RotaTeq vaccine after 12 weeks of age. No adverse affects. No other information. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested. This is one report of several from the same source.
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 male child who was vaccinated PO with a first 2 mL dose of RotaTeq vaccine after 12 weeks of age. No adverse effects. No other information. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested. This is one report of several from the same source.
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a female child who was vaccinated PO with a first 2 mL dose of RotaTeq vaccine after 12 weeks of age. No adverse affects. No other information. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested. This is on report of several from the same source.
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a female child who was vaccinated PO with a first 2 mL dose of RotaTeq vaccine after 12 weeks of age. No adverse affects. No other information. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested. This is one report of several from the same source.
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a female child who was vaccinated PO with a first 2 mL dose RotaTeq vaccine after 12 weeks of age. No adverse affects. No other information. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been sought. This is one report of several from the same source.
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a female child who was vaccinated PO with a first 2 mL dose of RotaTeq vaccine after 12 weeks of age. No adverse affects. No other information. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested. This is one of several reports from the same source.
Age: 0.25
Sex: U
Vaccine: RV5
Symptoms: Kawasaki's disease
Clinical narrative: Information has been received from a physician concern a 3 month old patient who was vaccinated with RotaTeq vaccine (Lot not provided). Subsequently, the patient experienced Kawasaki disease and was hospitalized. Additional information has been requested. This is one of several reports from the same source.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Initial and follow-up information has been received from a physician concerning an 18 year old female student with a penicillin allergy and no reported pertinent medical history, who on 07-AUG-2007 was vaccinated in the left arm with her first dose of Gardasil vaccine (LOT# 658100/0525U). There was no concomitant medication reported. There were no illnesses at the time of the vaccination. On 10-AUG-2007 in the evening, 72 hours after her Gardasil vaccination, the patient developed extensive urticaria (also reported as a hive-like rash) that lasted 24 hours. On 11-AUG-2007, the patient recovered. On 08-OCT-2007, the patient reported the rash at the follow-up appointment for the second HPV injection. No laboratory diagnostics were performed. No product quality complaint was involved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Drug exposure during pregnancy, Smear cervix abnormal, Ultrasound foetal, Ultrasound scan normal
Clinical narrative: Information has been received from a certified medical assistant concerning a 17 year old female with no drug reactions/allergies and no report of medical history who on 12-MAR-2007 was vaccinated with the first dose of Gardasil vaccine, 0.5 mL intramuscularly.  There was no concomitant medication. The patient sought medical attention. On 09-MAY-2007, the patient was determined to be 17 weeks pregnant (LMP was 23-JAN-2007). An ultrasound on 09-MAY-2007 was normal. The medical assistant also reported that the patient's pap smear in March 2007 was negative, but a repeat pap smear on 23-May-2007 revealed low grade squamous intraepithelial lesion. Additional information has been requested.  01/07/08 This is in follow-up to report(s) previously submitted on 11/14/2007. Initial and follow-up information has been received from a certified medical assistant concerning a 17 year old female with no drug reactions/allergies and no reported medical history, who on 12-MAR-2007 was vaccinated with the first dose of GARDASIL 0.5 ml intramuscularly. Concomitant therapy included prenatal vitamins. The patient sought medical attention. On 09-MAY-2007 the patient was determined to be 17 weeks pregnant (LMP was 23-JAN-2007). The prenatal vitamins were taken during "all of the pregnancy". An ultrasound on 09-MAY-2007 was normal. The medical assistant also reported that the patient's pap smear in March 2007 was negative, but a repeat pap smear on 23-MAY-2007 revealed low grade squamous intraepithelial lesion. The patient's last menstrual period was 23-JAN-2007 and her estimated delivery date was 30-OCT-2007. The patient did not have any previous pregnancies. On 23-OCT-2007 the patient gave birth to a liveborn female infant. The infant weighed 7 pounds 2 ounces and was 19 1/2 inches long. The infant's apgar score was 8/9. The infant was normal. There were no congenital anomalies, complications, or abnormalities. There were no complications during pregnancy, labor/delivery, no diagnostic tests, and no infections or illnesses during pregnancy. At the time of the report, the outcome of the patient was unknown. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Syncope
Clinical narrative: Information has been received from a health professional concerning a 14 year old female who was vaccinated with her second dose of Gardasil vaccine intramuscularly. The patient fainted and fell on the floor after receiving the second dose. The patient collapsed on the floor and possibly hit her head. The patient was taken to the ER and released after examination. The patient had a history of fainting following blood draws and the patient had not eaten prior to the vaccination. Subsequently, the patient recovered. Additional information was received and entered on 16-OCT-2007. On 10-SEP-2007, the patient experienced the above adverse events. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a health professional concerning a female who in May 2007, was vaccinated with her first dose of GARDASIL vaccine (yeast) when she was seeing another physician. A pap smear was performed and the results were abnormal. The patient sought unspecified medical attention and her outcome is unknown. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling hot, Stomach discomfort, Urticaria
Clinical narrative: Information has been received from a health professional concerning a 27 year old female who on 02-AUG-2007 was vaccinated with her first dose of GARDASIL vaccine (yeast) (lot# 658084/0524U). On 27-SEP-2007 the patient was vaccinated with her second dose of GARDASIL vaccine (yeast) (lot# 658563/1063U). On 29-SEP-2007 the patient was breaking out in hives all over her body, feeling sun burned and experienced an upset stomach. The patient sought medical attention by calling the doctor's office and was instructed to take diphenhydramine hydrochloride (Benadryl). Subsequently, the patient recovered from hives, feeling sun burned and upset stomach. The patient did not experience any adverse events after Dose 1 of GARDASIL vaccine (yeast). Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Menorrhagia, Ultrasound pelvis, Vaccine positive rechallenge
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 24 year old female who on 25-JUL-2007 was vaccinated IM with a first dose of GARDASIL vaccine (yeast), lot #657868/0523U. On an unspecified date the patient received a second dose of GARDASIL vaccine (yeast), lot #658558/1061U. Concomitant therapy included alprazolam (XANAX) and duloxetine hydrochloride (CYMBALTA). On 01-AUG-2007 the patient experienced heavy menstrual bleeding. The patient experienced the excessive menstrual bleeding after her first dose of GARDASIL vaccine (yeast). In September 2007, the patient experienced another episode of heavy menstrual bleeding. The patient saw the Nurse Practitioner, and a pelvic sonogram was performed (results not reported). The patient's outcome was not reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Haemoglobin, Menorrhagia
Clinical narrative: Information has been received from a nurse practitioner concerning a 22 year old female who on 21-NOV-2006 received her 1st 0.5 ml dose of GARDASIL vaccine (yeast) intramuscularly (lot# 654540/0800F). The nurse practitioner noted that on 22-Jan-2007 the patient developed heavy bleeding. The patient has received all 3 doses of GARDASIL vaccine (yeast) (lot # 654540/0800F, 653937/0637F, 655618/0186U respectively). The patient was concomitantly taking drospirenone (+) ethinyl estradiol (YASIN) at the time of the vaccination. The patient received unspecified medical attention. Per the nurse practitioner, the patient recovered from excessive menstrual bleeding. Additional information has been requested. This is one of several cases, from the same source.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Menstrual disorder
Clinical narrative: Information has been received from a physician assistant concerning a 22 year old female who in April 2007 and June 2007, was vaccinated with a first and second dose of Gardasil vaccine. Since June 2007, the patient has experienced abnormal menstrual cycles. The patient received the 3rd dose of Gardasil in Oct 2007. The patient received unspecified medical attention and at the time of this report it is unknown if she has recovered. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from a Certified Medical Assistant concerning a 12 year old female patient who on 19-JUN-2007 was vaccinated IM with her first does of Gardasil vaccine, Lot #656051/0244U. concomitant therapy included Menactra and Boostrix. The patient has not had a menstrual period since she received the first dose of Gardasil vaccine on 19-JUN-2007. Unspecified medical attention was sought. At the time of the report the event was ongoing. Additional information has been requested. This is in follow-up to report(s) previously submitted on 11/14/2007.  Information has been received from a licensed practical nurse concerning a 13 year old female patient with no medical history of allergies who on 19-JUN-2007, was vaccinated IM with a first dose of GARDASIL (lot #655051/0244U).  Concomitant therapy included MENACTRA and BOOSTRIX.  The patient has not had a menstrual period since she received the first dose of GARDASIL on 12-JUN-2007.  Unspecified medical attentino was sought.  No laboratory diagnostic studies were performed.  At the time of this report.  The patient's outcome was unknown.  No product quality complaint was involved.  Additional information is not expected.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Injection site pain, Injection site reaction, Muscle spasms
Clinical narrative: Information has been received from a nurse practitioner concerning a 28 year old female who on 08-OCT-2007 was vaccinated with GARDASIL vaccine (yeast). Subsequently the patient received a dose of GARDASIL vaccine (yeast) and experienced a pain that was like a muscle cramp at the injection site (unspecified). The pain resolved within a few minutes after the administration of the dose. It was reported the patient was seen by the physician. Patient Quality Complaints (PQC) was not involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Inappropriate schedule of drug administration, Pyrexia, Underdose
Clinical narrative: Information has been received from a consumer concerning her 15 year old daughter with a penicillin allergy who on 25-JUL-2007 was vaccinated IM with a first dose of GARDASIL vaccine (yeast). It was reported that when the vaccine was administered, some of it leaked out of the syringe (noted to not be a syringe issue). Another full dose was administered to the patient. There was no concomitant medication. On 27-JUL-2007 "a few days later", the patient experienced a fever of 104F. The physician did not attribute fever to vaccine. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. On 30-JUL-2007 3 days after receiving the vaccine, the patient's temperature returned to normal. No product quality complaint was involved. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Tremor, Vaccine positive rechallenge
Clinical narrative: Information has been received from a registered nurse concerning a 26 year old female with gout, gastroesophageal reflux disease and hypersensitivity to Reglan, who on 22-MAR-2007 was vaccinated in the right hip with a first dose of Gardasil vaccine (Lot #656051/0244U). Concomitant therapy included "Lo/Ovral-28". Subsequently, the patient developed body tremors for several days and recovered. On 30-MAY-2007, the patient was vaccinated into the right deltoid with a second dose of Gardasil vaccine (Lot #657737/0522U). Subsequently the patient developed body tremors. It was reported that the body tremors were more severe and prolonged after the first dose of Gardasil vaccine was given. The patient was in the office for the 3rd dose of Gardasil vaccine, the provider did not feel comfortable giving the third dose and the therapy with Gardasil vaccine was stopped until verified with the physician. Subsequently the patient recovered fully. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Rheumatoid arthritis
Clinical narrative: Information has been received from a nurse concerning a 21 year old female patient with rheumatoid arthritis, chronic anemia and a history of hip replacement in 2003 due to Rheumatoid arthritis who in 09-JUL-2007 was vaccinated 0.5 ml IM with a dose of GARDASIL vaccine (yeast) (lot # 657737/0522U). Concomitant therapy included etanercept (ENBREL), ethinyl estradiol (+) norelgestromin (ORTHO EVRA). In October 2007, about 2-3 months post vaccination of GARDASIL vaccine (yeast) the patient developed Rheumatoid arthritis flare up that was not controlled with the etanercept (ENBREL) therapy. The patient switched to infliximab (REMICADE) therapy which controlled her symptoms. At the time of this report the patient recovered. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Cold sweat, Pallor, Peripheral coldness
Clinical narrative: Information has been received from a medical assistant concerning an 11 year old female who on 09-APR-2007 was vaccinated intramuscularly with a first dose of Gardasil vaccine (lot #659435/1265U). On 09-OCT-2007, the patient was vaccinated with a third dose of Gardasil vaccine. Concomitant vaccination on the same day included Havrix. On 09-OCT-2007, when the patient was coming out of the room she bumped into the wall, her eyes were open, face was very pale, skin was cold and clammy. The patient's mother caught her and assisted her to the floor. The patient was given candy and a drink. The patient rested in the office and was then fine. The office staff does not believe she fainted or loss consciousness. At the time of the report the patient was doing fine. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2007. Initial and follow-up information has been received from a medical assistant concerning an 11 year old female who on 09-APR-2007 was vaccinated intramuscularly with a first dose of GARDASIL vaccine. On 09-OCT-2007 the patient was vaccinated into the left arm with a third dose of GARDASIL (Lot #659402/1265U). Concomitant vaccination on the same day included HAVRIX vaccine. On 09-OCT-2007 when the patient was coming out of the room she bumped into the wall, her eyes were open, face was very pale, skin was cold and clammy and the patient passed out. The patient's mother caught her and assisted her to the floor. The patient was given candy and a drink. The patient rested in the office and was then fine. The office staff does not believe she fainted or lost consciousness. At the time of the report the patient was doing fine. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed, Urine human chorionic gonadotropin negative
Clinical narrative: Information has been received from a registered nurse concerning a 26 year old female with a fish allergy and a history of brain surgery who on 09-AUG-2007 and also reported as 09-SEP-2007 was vaccinated intramuscularly in the arm with a first dose of GARDASIL vaccine (yeast) (Lot #658100/0525U). Concomitant therapy included lamotrigine (LAMICTAL). Subsequently the patient experienced a delay in her menstrual period at the time of the report the patient was three weeks late for the second menstrual period. The patient's urine pregnancy test was negative. The patient was seen for a follow-up exam. At the time of the report the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a consumer concerning her daughter who was vaccinated with a second dose of Gardasil vaccine. Subsequently, the patient experienced "a lot of side effects". She had to have an "MRI" (illegible data) and her physician said "it was from the vaccine." At the time of this report the patient's outcome was unknown. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Palpitations, Pruritus
Clinical narrative: Information has been received from a nurse concerning a female who on 08-OCT-2007 was vaccinated with GARDASIL vaccine (yeast). On 09-OCT-2007 the patient developed heart palpitations, pain and itching on the arm but not at the injection site (arm not specified). The patient did receive unspecified medical attention. At the time of this report, the patient's heart palpitations, pain and itching on their arm is persisting per the nurse. Additional information has been requested.  01/07/08 This is in follow-up to report(s) previously submitted on 11/14/2007. No additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Injection site pain, Nausea, Pain, Pregnancy test positive
Clinical narrative: Information has been received from a physician concerning two females (age was not reported) who were recently vaccinated intramuscularly with the 3rd 0.5mL dose of Gardasil vaccine. Both patients reported experiencing injection site pain, general body aches and pain that lasted several days after the injection. Patient's received unspecified medical attention. Outcome is not known on either patient at the time of this report. In follow-up it was reported through Merck's Pregnancy Registry and the physician that one of the two patients reported previously was complaining daily of general body aches, nausea and vomiting. It was reported that "they performed blood-work and it turned out the patient was pregnant." The physician reported that he thought the patient's reaction was related to the Gardasil vaccine. The physician also reported that another patient after third dose of Gardasil vaccine had injection pain for 1-2 days (WAES # 0710USA05320). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning two females (age was not reported) who were recently vaccinated intramuscularly with the 3rd 0.5mL dose of Gardasil vaccine. Both patients reported experiencing injection site pain, general body aches and pain that lasted several days after the injection. Patient's received unspecified medical attention. Outcome is not known on either patient at the time of this report. In follow-up it was reported through Merck's Pregnancy Registry and the physician that one of the two patients reported previously was complaining daily of general body aches, nausea and vomiting. It was reported that "they performed blood-work and it turned out the patient was pregnant." The physician reported that he thought the patient's reaction was related to the Gardasil vaccine. The physician also reported that another patient after third dose of Gardasil vaccine had injection pain for 1-2 days (WAES # 0710USA05320). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash, Rash
Clinical narrative: Information has been received from a physician concerning a female (age unknown), who, on an unspecified date, was vaccinated with a first dose of GARDASIL vaccine (yeast). Subsequently, the patient developed a rash on her face and on her arm at the injection site. The rash lasted 2 to 3 days. The patient told the physician about her rash at the next office visit. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.