chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site discolouration
Clinical narrative: Information has been received from a female registered nurse concerning a 22 year old female who on 10-SEP-2007 was vaccinated with her first 0.5 ml dose of Gardasil (Lot #658556/1060U) intramuscularly in the left arm. The patient developed a 2 inch by 2 inch area at injection site which remains hypopigmented. On 24-OCT-2007 patient was seen in the doctors office and hypopigmentation continued on the left arm. Patient has not been wearing a bandaid or sun tanning. No additional information is available at this time. Additional information has been requested.
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with Gardasil (lot # not reported), 0.5mL, intramuscularly.  Concomitant therapy included Menactra.  The patient fainted after receiving her Gardasil injection, date not reported.  No laboratory studies were performed.  The patient recovered on the "same day the vaccine was given".  Unspecified medical attention was sought.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Syncope
Clinical narrative: Information has been received from a physician concerning a female who in October 2007, "about two weeks ago" was vaccinated with the first intramuscular dose of Gardasil (lot # not reported).  In October 2007, "around two weeks ago" the patient fainted and became nauseous.  Subsequently, the patient recovered, on an unknown date.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Hepatic enzyme increased, Hepatic function abnormal, Malaise
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female with no pertinent medical history or drug reactions/allergies who in April 2007, was vaccinated with the first dose of Gardasil (lot # not reported), 0.5mL, intramuscularly in the deltoid.  In "early" June 2007, the patient received her second dose of Gardasil.  There were no concomitant medication.  In "late or early" July 2007, the patient became sick.  She had an increase in her liver enzymes during her illness.  As of 01-Nov-2007 the patient had not recovered.  The patient is under the care of the practice.  Additional information has been requested. In follow up information it was reported that in ??-OCT-2007 patient received a dose "number of previous dose 0" of GARDASIL lot #659437/1266U IM into left deltoid at 04:00 PM. It was mentioned that in November, 2007 her hepatic function tests (LFTs) was noted elevated and she complained of fatigue. She had complete blood count (CBC with diff) with differntial, complete metabolic panel, liver function test and thyroid function laboratory test was done. No result available except LFT being elevated. She recovered in December 2007. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Pregnancy test negative
Clinical narrative: Information has been received from a nurse concerning a female with no pertinent medical history or prior drug reactions/ allergies who on 08-JUN-2007 was vaccinated with the first dose of Gardasil (lot #653735/0668F), 0.5ml intramuscularly. The patient's last menstrual period occurred during the last week of June 2007. On 09-AUG-2007 the patient received her second dose of Gardasil (lot# 655617/1447F). On 01-NOV-2007 the patient reported that "recent" laboratory test included a pregnancy test with a negative result. No other symptoms were reported. Unspecified medical attention was sought. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/14/2007. Initial and follow up information have been received from a nurse concerning a black female with no pertinent medical history or prior drug reactions / allergies who on 08-JUN-2007 was vaccinated with the first dose of GARDASIL (lot # 653735/0688F), 0.5mL Intramuscularly. The patient's last menstrual period occurred on 28-MAY-2007. On 09-AUG-2007 the patient received her second dose of GARDASIL (lot# 655617/1447F). It was reported that from approximately the beginning of July the patient "felt like she was going to get her menses, experiencing cramps and nausea." On 01-NOV-2007 the patient was seen by her physician and reported that "recent" laboratory test included a pregnancy test with a negative result. No other symptoms were reported. On 18-DEC-2007 the patient was seen by her OBGYN and reported that she had her menses (date not provided). On 18-DEC-2007 the patienet received her third vaccination of GARDASIL (lot# not provided). Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Injection site abscess, Pain, Swelling
Clinical narrative: Information has been received from a 26 year old female Pharmacy student who on 15-MAR-2007 was vaccinated intramuscularly with a 0.5 ml dose of Gardasil. Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO TRI-CYCLEN LO). On 20-SEP-2007 the patient was vaccinated with third dose of Gardasil. On 23-SEP-2007 the patient developed a small bubble under the skin at the injection site. This bubble lasted for a couple of months. On 01-NOV-2007, the bubble got "hug", red, swollen and painful. "It looked like a bite." At the time of the report the patient's outcome was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Device leakage, Pain in extremity, Underdose
Clinical narrative: Initial and follow up information has been received from a medical assistant concerning a patient who on 29-AUG-2007 was vaccinated with a first dose of Gardasil (lot # unknown).  On 29-AUG-2007 the patient's arm was sore from the vaccination.  On 02-NOV-2007 the patient was vaccinated at the physician's office with a second dose of Gardasil.  The patient did not receive the full second dose of Gardasil.  As the vaccine was being administered some of the dose leaked from the syringe where the needle was attached.  The syringe was not a pre-filled Gardasil syringe; the dose was drawn up with a syringe from a single dose vial.  The patient is not experiencing any known symptoms.  Follow-up information was received and the patient's arm was sore from the second vaccination.  At the time of reporting it was unknown if the patient had recovered.  No further information was available.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a company representative concerning a female who was vaccinated with Gardasil. there was no concomitant medication. Subsequently the patient fainted. No additional information provided. No lot number provided. Physician's name was not specified by Representative. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: Information has been received from a nurse practitioner concerning a 22 year old female with no pertinent medical history and a drug hypersensitivity to clindamycin who on 01-NOV-2007 was vaccinated with a first dose of Gardasil (lot #659435/1265U).  There was no concomitant therapy.  On 01-NOV-2007 while the patient was checking out of the office she became dizzy and light headed.  Medical attention was sought.  The patient rested in the office for 30 minutes and then left.  The patient called the office 02-NOV-2007 and reported that she felt queasy and light headed.  The patient was told to drink fluids and rest.  At the time of the report the patient had not recovered.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a female licensed practical nurse concerning a 15 year old female patient with no medical history who on 20-Aug-2007 was vaccinated with her first 0.5 ml dose of Gardasil (Lot #654741/1208F) intramuscularly.  There was no concomitant medication.  On 01-Nov-2007 the patient was in the doctor's office to receive her second dose of Gardasil but did not want to receive it at that time.  She stated that within a few hours after receiving the first dose on 20-Aug-2007 she developed hives on her torso but not at the injection site.  She took Benadryl and her symptoms resolved within a day.  The second dose of Gardasil was not administered.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Clinical narrative: Information has been received from a registered nurse, via a company representative, concerning a female patient (age not specified) who in October 2007 ("last week"), was vaccinated IM with a 0.5 ml dose of Gardasil.  Following the vaccination, the patient fainted, and received unspecified treatment in the office.  At the time of this report, the patient had recovered from the event (duration not specified).  Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/14/2007. Initial and follow up information has been received from a registered nurse, concerning a 23 year old female college student with no medical conditions, who  25-OCT-2007, at 3:00 PM, was vaccinated IM in deltoid with the third dose, 0.5 ml. of GARDASIL (lot #654539/0742U). There was no illness at the time of vaccination. Immediately following the vaccination, the patient felt lightheaded (previously reported as fainted), and had to lie down for 15 minutes. At the time of this report, the patient had recovered from the event. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Blood iron normal, Electrocardiogram normal, Full blood count normal, Laboratory test, Metabolic function test
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female with penicillin allergy who on 26-JUL-2007 was vaccinated with the first dose of Gardasil (Lot #658094/0524U).  On 12-OCT-2007, she was vaccinated intramuscularly in unspecified deltoid muscle with the second dose of Gardasil (Lot #659435/1265U).  Concomitant therapy included influenza virus vaccine (unspecified).  On 12-OCT-2007, the patient fainted after receiving the second Gardasil vaccine.  On 30-OCT-2007, the patient was examined by the physician because of four more episodes of fainting (no previous history of fainting before the 12-OCT-2007 episode).  Laboratory work on 30-OCT-2007 for a complete blood count, iron level and a metabolic panel was within normal limits (levels unspecified).  An electrocardiogram did not show any abnormalities.  The patient's experience persisted.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female with penicillin allergy who on 26-JUL-2007 was vaccinated with the first dose of Gardasil (Lot #658094/0524U).  On 12-OCT-2007, she was vaccinated intramuscularly in unspecified deltoid muscle with the second dose of Gardasil (Lot #659435/1265U).  Concomitant therapy included influenza virus vaccine (unspecified).  On 12-OCT-2007, the patient fainted after receiving the second Gardasil vaccine.  On 30-OCT-2007, the patient was examined by the physician because of four more episodes of fainting (no previous history of fainting before the 12-OCT-2007 episode).  Laboratory work on 30-OCT-2007 for a complete blood count, iron level and a metabolic panel was within normal limits (levels unspecified).  An electrocardiogram did not show any abnormalities.  The patient's experience persisted.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site movement impairment, Injection site pain
Clinical narrative: Information has been received from a healthcare worker concerning a 16 year old female with no known allergies who on 14-Aug-2007 was vaccinated with the first dose of Gardasil.  On 25-Oct-2007, she was vaccinated intramuscularly in the right deltoid muscle with the second dose of Gardasil.  On 25-Oct-2007, the patient experienced painful injection site which had gotten progressively more painful, starting after vaccination with Gardasil.  The patient had difficulty moving the arm because it was "very painful".  The pain in the arm was in an area 2 inches around the injection site and the area was not red or swollen.  The patient's painful injection site persisted.  The patient sought medical attention by calling the physician's office.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia
Clinical narrative: Information has been received from a nurse concerning a female who was vaccinated with Gardasil (lot# not reported), injection. Subsequently the patient experienced numbness in her arm and legs. The patient sought unspecified medical attention. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Rash
Clinical narrative: Information has been received from a 27 year old female who was vaccinated three times with Gardasil.  Subsequently, the patient experienced arm pain with all 3 doses and after the third dose, broke out with a rash on the arm that she had received the vaccine.  The patient outcome was not reported.  No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Pallor, Respiratory arrest, Syncope
Clinical narrative: Information has been received from a health professional concerning a 16 year old white female student with syncope after receiving kindergarten shots et zoole flu vaccine, and no known allergies, who on 01-Nov-2007 was vaccinated IM in the left deltoid, with the second dose of Gardasil (lot #658560/1062U).  There was no concomitant medication.  The patient had no adverse event after the first dose of Gardasil.  On 01-Nov-2007, three seconds after the second dose the patient fainted on exam table.  Unknown medical attention was sought.  She was sitting and lied down.  She was very pale and wasn't breathing for 5 seconds.  She came out of it, got her color back and was fine afterwards. The patient was recovered without treatment. No product quality complaint was involved. No product quality complaint was involved. Follow up information indicated that the patient needed no treatment. No diagnostic work up was done on the patient. No hospitalization or as a out patient.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse, via a company representative, concerning a female patient (age not specified) who in October 2007 ("last week"), was vaccinated IM with a 0.5 ml dose of Gardasil.  Following the vaccination, the patient fainted, and received unspecified treatment in the office.  At the time of this report, the patient had recovered from the event (duration not specified).  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a consumer concerning her daughter, a 20 year old female with a history of severe reaction to wasp stings who on 05-SEP-2007 was vaccinated with her first dose of Gardasil.  There was not concomitant medication.  The patient woke up the next morning on 06-SEP-2007 with hives on her torso and knees.  She was treated with an intramuscular shot of an unspecified antihistamine and a prescription for oral steroids.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: DTAP, HPV4, MNQ
Symptoms: Back pain
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 13 year old female patient, who on 27-Nov-2007 was vaccinated with a dose of Gardasil (lot #657736/0389U).  Concomitant vaccine therapy included diphtheria toxoid (+) pertussis acellular vaccine (manufacturer unspecified) (+) Menactra.  On 29-Nov-2007 the patient reported lower back pain.  At the time of this report, the patient had not recovered.  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 physician concerning a 17-week-old female who on 06-NOV-2007 was vaccinated with the first dose of RotaTeq. The patient was seen in the physician's office. 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 physician concerning a 22-week-old male who on 06-NOV-2007 was vaccinated with the first dose of Rotateq.  The patient was seen in the physician's office.  Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician's assistant (PA) concerning an infant who was vaccinated with the first dose of Rotateq after 13 weeks of age.  It was unknown if medication attention was sought.  Additional information has been requested.
Age: 0.36
Sex: M
Vaccine: RV5
Symptoms: Culture stool negative, Culture stool positive, Diarrhoea, Gastroenteritis, Gastroenteritis rotavirus
Clinical narrative: Information has been received from a physician concerning a 22 week old (pre-term at 32 weeks) male with no other medical history and no drug allergies who on 24-JUL-2007 and 24-SEP-2007 was vaccinated PO with his first and second dose of RotaTeq (lot# 656184/0558U and 656846/0940U). There was no concomitant medication. On 20-OCT-2007 the patient experienced diarrhea and "gastroinitis." The physician performed a "stool test" that confirmed results of rotavirus. Subsequently, the patient recovered. There was no product quality complaint. It was noted that the physician will give the patient the third dose of RotaTeq which will be due next week. Additional information has been requested. 03/04/08 This is in follow-up to report(s) previously submitted on 12/14/2007. Follow-up information from the reporting physician and medical records indicated that on 19-NOV-2007 the patient was vaccinated PO with his third dose of ROTATEQ (lot# 657666/1391U). On 20-OCT-2007 stool cultures were performed which revealed a negative result for C. difficile toxin A/B and a positive result for rotavirus. Lab results for campyobacter were pending at the time of this report. The patient was diagnosed with gastroenteritis rotavirus. Additional information has been requested.
Age: 0.36
Sex: M
Vaccine: RV5
Symptoms: Rotavirus infection
Clinical narrative: Information has been received from a physician concerning a 22 week old (pre-term at 32 weeks) male with no other medical history and no drug allergies who on 24-JUL-2007 and 24-SEP-2007 was vaccinated PO with his first and second dose of RotaTeq (lot# 656184/0558U and 656846/0940U). There was no concomitant medication. On 20-OCT-2007 the patient experienced diarrhea and "gastroinitis." The physician performed a "stool test" that confirmed results of rotavirus. Subsequently, the patient recovered. There was no product quality complaint. It was noted that the physician will give the patient the third dose of RotaTeq which will be due next week. Additional information has been requested. 03/04/08 This is in follow-up to report(s) previously submitted on 12/14/2007. Follow-up information from the reporting physician and medical records indicated that on 19-NOV-2007 the patient was vaccinated PO with his third dose of ROTATEQ (lot# 657666/1391U). On 20-OCT-2007 stool cultures were performed which revealed a negative result for C. difficile toxin A/B and a positive result for rotavirus. Lab results for campyobacter were pending at the time of this report. The patient was diagnosed with gastroenteritis rotavirus. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Faeces discoloured, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a male with no drug allergies who on 12-Oct-2007 was vaccinated PO with a dose of Rotateq (lot #657661/0973U).  On approximately 14-Oct-2007 about two days post vaccination, the patient experienced vomiting and diarrhea that was greenish brown in color.  Unspecified medical attention was sought.  No labs or diagnostic studies were performed.  Subsequently, the patient recovered.  There was no product quality complaint.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/14/2007. Information has been received indicating that a 10 week old male with gastrooesophageal reflux who on 12-OCT-2007 at 13:15 was vaccinated PO with the first dose of ROTATEQ (lot# 657661/0973U). The patient has a history of GERD prior to vaccination. Concomitant vaccinations administered on that same day at 13:15 included the first IM dose of ACT-HIB (lot# 656518/0258U) in the right thigh, the first IM dose of PEDIARIX (lot# AC21B125AA) in the left thigh and PREVNAR (lot# 890143P) in the right thigh. On 15-OCT-2007 (also reported as approximately 14-OCT-2007), the patient experienced vomiting, greenish brown diarrhea and diarrhea. The patient did not seek medical attention. Subsequently, the patient recovered. It was noted that the patient received a dose of ROTATEQ in December 2007 with no problems of vomiting and diarrhea noted. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated PO with a dose of RotaTeq. Subsequently, within a day or two after receiving the vaccine, the patient began vomiting. It was unknown if this was the first, second, or third dose of the vaccine, or if the baby will go on to received further doses. It was noted that the patient was seen by a physician. The outcome was recovered. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
Clinical narrative: Information has been received from a registered nurse concerning a 2 week old patient who on 08-Nov-2007 was vaccinated with a dose of Rotateq.  The patient was not experiencing any known symptoms.  It was unknown whether medical attention was sought.  There was no product quality complaint.  This is one of two reports from the same patient.  Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Gastroenteritis salmonella
Clinical narrative: Information has been received from a physician concerning a child who was vaccinated PO with the first 2.0 ml dose of Rotateq.  The physician reported that in 2007, the patient developed Salmonella based gastroenteritis.  The patient was seen in the physician's office.  The patient was noted to have some residual loose stools, but no blood.  At the time of this report, the patient still had Salmonella in the stool, but was considered to be recovering.  Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Body temperature fluctuation, Body temperature increased, Dermatitis diaper, Diarrhoea, Faeces discoloured
Clinical narrative: Information has been received from a father concerning his 6-month-old son who had no medical history or allergies who on 08-NOV-2007, at around 10:00, was vaccinated PO with a dose of Rotateq (Lot #657515/0668U).  The father reported that 08-NOV-2007, between 4-6 pm, his son's temperature spiked to 103 degrees and he started having watery green stools about every hour and a half.  On 10-NOV-2007, the patient was taken to the Emergency Room (ER).  No additional laboratory/diagnostic tests were performed.  Since then, his temperature was going up and down and as of 12-NOV-2007, his temperature was about 100 degrees.  He still had the watery green stools and had extreme diaper rash.  Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated po with a second dose of RotaTeq. Subsequently the patient experienced vomiting. Very little information was provided regarding this adverse experience. The outcome was reported as recovered. There was no product quality complaint. This is one report of several from the same source. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
Clinical narrative: Information has been received from a medical assistant concerning her 20 week old son who on 06-Apr-2007 received his first oral dose of Rotateq at the age of 20 weeks.  He received his second oral dose of Rotateq and has not received a third dose.  No problems were reported.  It was not reported if the patient sought medical attention.  A product quality complaint was not reported.  Further details were not available.  Additional information has been requested. Follow up information from the physician provided no additional information or current patient status.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal pain, Diarrhoea, Faeces discoloured, Fluid intake reduced, High-pitched crying
Clinical narrative: Information has been received from a physician concerning a 9 week old male with no known pre-existing allergies, birth defects or medical conditions, who on 29-OCT-2007 received his first oral dose of Rotateq (lot #656186/1235F).  Concomitant vaccinations included a first dose of PedvaxHIB (lot #656522/0437U) intramuscular in the right thigh, a first dose of Pediarix (lot #AC21B133BA) intramuscular in the left thigh and a first dose of Prevnar (lot #B701438) in the left thigh.  There was no reported illness at the time of vaccination.  On the night following the vaccinations (29-OCT-2007), it was reported that he developed irritability with a high pitched cry, and fever lasting 48 hours.  It was reported that the sites of injections were swollen.  On 01-NOV-2007 it was reported that he developed green watery stools, knees to chest crampy pain upon eating, frequent night time waking screaming, and yellow jelly like stools for 2-3 days and he was drinking 50% of his usual intake.  It was reported that there were no adverse events following previous vaccination.  The patient sought emergency room and/or a doctor's visit (not specified).  It was reported that he had a normal physical exam and that diagnostic studies and laboratory tests were not ordered.  Current patient status was not reported.  A product quality complaint was not reported.  Additional information has been requested. 03/04/08 This is in follow-up to report(s) previously submitted on 12/14/2007. Follow up information indicated that the patient's crampy abdominal pains resolved by one month after vaccination and the diarrhea resolved in about two weeks. As of 30-NOV-2007, the patient had recovered. The patient was reported to have been growing and developing normally. Additional information has been requested.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Injection site swelling, Irritability, Mucous stools, No reaction on previous exposure to drug, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 9 week old male with no known pre-existing allergies, birth defects or medical conditions, who on 29-OCT-2007 received his first oral dose of Rotateq (lot #656186/1235F).  Concomitant vaccinations included a first dose of PedvaxHIB (lot #656522/0437U) intramuscular in the right thigh, a first dose of Pediarix (lot #AC21B133BA) intramuscular in the left thigh and a first dose of Prevnar (lot #B701438) in the left thigh.  There was no reported illness at the time of vaccination.  On the night following the vaccinations (29-OCT-2007), it was reported that he developed irritability with a high pitched cry, and fever lasting 48 hours.  It was reported that the sites of injections were swollen.  On 01-NOV-2007 it was reported that he developed green watery stools, knees to chest crampy pain upon eating, frequent night time waking screaming, and yellow jelly like stools for 2-3 days and he was drinking 50% of his usual intake.  It was reported that there were no adverse events following previous vaccination.  The patient sought emergency room and/or a doctor's visit (not specified).  It was reported that he had a normal physical exam and that diagnostic studies and laboratory tests were not ordered.  Current patient status was not reported.  A product quality complaint was not reported.  Additional information has been requested. 03/04/08 This is in follow-up to report(s) previously submitted on 12/14/2007. Follow up information indicated that the patient's crampy abdominal pains resolved by one month after vaccination and the diarrhea resolved in about two weeks. As of 30-NOV-2007, the patient had recovered. The patient was reported to have been growing and developing normally. Additional information has been requested.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Screaming, Sleep disorder
Clinical narrative: Information has been received from a physician concerning a 9 week old male with no known pre-existing allergies, birth defects or medical conditions, who on 29-OCT-2007 received his first oral dose of Rotateq (lot #656186/1235F).  Concomitant vaccinations included a first dose of PedvaxHIB (lot #656522/0437U) intramuscular in the right thigh, a first dose of Pediarix (lot #AC21B133BA) intramuscular in the left thigh and a first dose of Prevnar (lot #B701438) in the left thigh.  There was no reported illness at the time of vaccination.  On the night following the vaccinations (29-OCT-2007), it was reported that he developed irritability with a high pitched cry, and fever lasting 48 hours.  It was reported that the sites of injections were swollen.  On 01-NOV-2007 it was reported that he developed green watery stools, knees to chest crampy pain upon eating, frequent night time waking screaming, and yellow jelly like stools for 2-3 days and he was drinking 50% of his usual intake.  It was reported that there were no adverse events following previous vaccination.  The patient sought emergency room and/or a doctor's visit (not specified).  It was reported that he had a normal physical exam and that diagnostic studies and laboratory tests were not ordered.  Current patient status was not reported.  A product quality complaint was not reported.  Additional information has been requested. 03/04/08 This is in follow-up to report(s) previously submitted on 12/14/2007. Follow up information indicated that the patient's crampy abdominal pains resolved by one month after vaccination and the diarrhea resolved in about two weeks. As of 30-NOV-2007, the patient had recovered. The patient was reported to have been growing and developing normally. Additional information has been requested.
Age: 0.35
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Abnormal faeces, Crying, Diarrhoea, Diarrhoea, Hypersomnia
Clinical narrative: Information has been received from a health professional concerning a 2 month old female, with no allergies and no medical history, who on 29-Oct-2007 was vaccinated with a 2 ml oral dose of Rotateq (lot #656706/0242U).  On 29-Oct-2007 the patient experienced high fever (over 101) and diarrhea.  Subsequently, the patient recovered within 24 hours.  No product quality complaint was involved.  No other information was provided.  Additional information has been requested. This is in follow-up to reports previously submitted on 12/14/2007 information has been received from a health professional concerning a 9 week old female, with no allergies and no medical history who on 29-Oct-2007 was vaccinated with a 2ml oral first dose of Rotateq (Lot# 656706/0242U). Concomitent vaccine administered on 29-OCT-2007, included a first dose in the left thigh of OMPC (Lot# 657180/0224U), a first dose in the right thigh of TRIPEDIA (lot# U2156AA), a first dose in the right thigh of IPOL (Lot# A0170) and a first dose in the left thigh of PREVNAR ) (Lot# B08700E). There was no illness at the time of vaccination and no adverse events following prior vaccination. On 29-OCT-2007, at 2:00 pm, the patient started receiving a high fever up to 103.1. It was reported that the patient looked very lethargic, sleeping a lot, and crying. The patient had two watery bowels with foul odor. The patient's symptoms subsided on 10-Oct-2007 and was considered to be recovered. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 0.35
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Lethargy, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 2 month old female, with no allergies and no medical history, who on 29-Oct-2007 was vaccinated with a 2 ml oral dose of Rotateq (lot #656706/0242U).  On 29-Oct-2007 the patient experienced high fever (over 101) and diarrhea.  Subsequently, the patient recovered within 24 hours.  No product quality complaint was involved.  No other information was provided.  Additional information has been requested. This is in follow-up to reports previously submitted on 12/14/2007 information has been received from a health professional concerning a 9 week old female, with no allergies and no medical history who on 29-Oct-2007 was vaccinated with a 2ml oral first dose of Rotateq (Lot# 656706/0242U). Concomitent vaccine administered on 29-OCT-2007, included a first dose in the left thigh of OMPC (Lot# 657180/0224U), a first dose in the right thigh of TRIPEDIA (lot# U2156AA), a first dose in the right thigh of IPOL (Lot# A0170) and a first dose in the left thigh of PREVNAR ) (Lot# B08700E). There was no illness at the time of vaccination and no adverse events following prior vaccination. On 29-OCT-2007, at 2:00 pm, the patient started receiving a high fever up to 103.1. It was reported that the patient looked very lethargic, sleeping a lot, and crying. The patient had two watery bowels with foul odor. The patient's symptoms subsided on 10-Oct-2007 and was considered to be recovered. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Accidental exposure, Infantile spitting up
Clinical narrative: Information has been received from registered nurse concerning an infant who was vaccinated with a dose of RotaTeq (lot# 657666/1391U). Subsequently the patient spit up the vaccine into his father's eye (WAES# 0711USA02988). It was unknown whether medical attention was sought. The outcome was unknown at the time of this report. There was no product quality complaint. This is one of two reports from the same source. Additional information has bee requested.
Sex: U
Vaccine: RV5
Symptoms: Abdominal pain, Crying
Clinical narrative: Information has been received from a physician concerning an infant patient who was vaccinated with a dose of Rotateq.  Subsequently the patient experienced abdominal pain and chronic crying.  Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a 5 month old female who in January 2007 was vaccinated with her first dose of Rotateq followed by her second dose at 8 months of age in April 2007.  Medical attention was sought at the physician's office.  There was no product quality complaint.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning an approximately 2 month old patient who was vaccinated PO with the first dose of RotaTeq (no lot number was given). Subsequently about 2-3 days post vaccination, the patient experienced "diarrhea that lasted for about a week." Unspecified medical attention was sought. Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a consumer concerning her daughter with a history of bronchiolitis on 18-May-2001 (WAES #01120973), a diagnosis of failure to thrive and no drug allergies who in approximately 2001 was vaccinated PO with a dose of Rotateq.  In approximately 2001 "within a week of receiving the vaccine," (It was noted that the patient participated in a clinical trial for Rotateq and was not sure if her daughter received the placebo or the vaccine.) the patient experienced diarrhea on and off.  Medical attention was sought through a physician.  No labs or diagnostic studies were performed.  The patient's outcome was not recovered.  There was no product quality complaint.  Additional information has been requested.
Age: 0.51
Sex: M
Vaccine: RV5
Symptoms: Gastroenteritis rotavirus, Laboratory test abnormal
Clinical narrative: Information has been received from a physician concerning an approximately 9 month old male who was vaccinated PO with the first, second and third 2.0 ml doses of Rotateq (no lot number was provided).  Subsequently, "the patient went to and got the rotavirus".  The patient sought unspecified medical attention.  The outcome was unknown.  There was no product quality complaint.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/14/2007. Follow-up information from the reporting physician indicated that an 8 month old (also reported as approximately 9 months old) male with no pre-existing medical conditions or allergies who on 13-APR-2007, 04-JUN-2007 and 09-AUG-2007 was vaccinated PO with his first, second and third doses of ROTATEQ (lot# "07680"). There was no illness the time of vaccination. Concomitant vaccinations administered on 13-APR-2007 included the first IM dose of COMVAX (lot# 655549/1415F), the first SC dose of IPOL (lot# 41032) and the first IM dose of DAPTACEL (lot# C2570). On 18-OCT-2007 the patient experienced gastroenteritis rotavirus while visiting confirmed by labs (results unavailable) as per parents. The patient sought unspecified medical attention. Subsequently, the patient recovered. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Rotavirus infection
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with all three doses of Rotateq and subsequently experienced a rotavirus infection.  The patient was seen by the physician for medical attention.  The outcome was unknown.  There was no product quality complaint.  No further information is available.
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a licensed practical nurse concerning an approximately 23 week old patient who on approximately 20-NOV-2007 was inadvertantly vaccinated PO with the first 2.0 ml dose of RotaTeq (lot# 657511/0553U) at 4 months old. Medical attention was sought at the physician's office. There was no product quality complaint. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 16 week old male who received a second dose of Rotateq and developed diarrhea after getting the second dose of the vaccine.  It was reported that the diarrhea continued for several weeks.  It was reported that the patient sought unspecified medical attention and the patient was referred to a G.I. clinic a month after getting the dose (impression, treatment and diagnosis not reported).  A product quality complaint was not reported.  Additional information has been requested.
Age: 0.1
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
Clinical narrative: Information has been received from a physician concerning a 1 month and 7 days old male who on 26-Nov-2007 was vaccinated PO with the first 2.0 mL dose of Rotateq.  It was unknown if medical attention was sought.  No adverse event was reported.  Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Choking
Clinical narrative: Information has been received from a registered nurse concerning a 2 month old patient who was vaccinated PO with a first dose of Rotateq.  The nurse reported that while administering the vaccine, the patient experienced choking.  No further information was provided.  The outcome was reported as recovered after vaccine was administered.  There was no product quality complaint.  Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, RV5
Symptoms: Immediate post-injection reaction, Vomiting
Clinical narrative: Information has been received from a healthcare worker concerning a 6 month old male with no reported medical history and no allergies who on 15-OCT-2007 and 19-OCT-2007 presented for his third oral dose of ROTATEQ and promptly vomited the dose. Concomitant vaccination on 15-OCT-2007 included PEDIARIX. On 19-OCt-2007, the staff attempted to again administer the third dose of RotaTeq (lot # 655868/1375F) and reportedly he vomited again. It was reported that the patient sought unspecified medial attention. There were no laboratory or diagnostic tests performed. At the time of this report, it was reported that the patient had recovered. A product quality complaint was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated PO with a second dose of Rotateq.  Subsequently the patient experienced vomiting.  Very little information was provided regarding this adverse experience.  The outcome was reported as recovered.  There was no product quality complaint.  This is one report of several from the same source.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue
Clinical narrative: Information has been received concerning a female who was vaccinated with the second dose of Gardasil.  Subsequently, the patient experienced dizziness, fatigue and tiredness.  The patient did not have any AE after the first dose.  It was unknown whether medical attention was sought.  The patient's dizziness and fatigue persisted.  No product quality complaint was involved.  Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 02-Nov-2007 was vaccinated IM in right deltoid with a 0.5 ml of first dose of Gardasil (lot #1266U).  There was no concomitant medication.  On 02-Nov-2007 the patient experienced urticaria on her chin and cheeks.  Unknown medical attention was sought.  The patient's urticaria on her chin and cheeks persisted.  No product quality complaint was involved.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy, Oedema peripheral
Clinical narrative: Information has been received from a nurse practitioner concerning a 12 year old female who in October 2007, was vaccinated with Gardasil (lot # not reported).  In October 2007, two days after she was given Gardasil the patient presented with a swollen thigh.  The patient then progressed to lymphadenopathy.  As of 05-Nov-2007, the patient's swollen thigh and lymphadenopathy persisted.  Unspecified medical attention was sought.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Erythema multiforme
Clinical narrative: Information has been received from a physician a female who was vaccinated with GARDASIL. Subsequently the patient experienced erythma, multiforme. Therapy with human papillomavirus vaccine was discontinued. The patient sought unspecified medical attention and her out come was unknown. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Antinuclear antibody negative, Arthralgia, Culture urine negative, Headache, Musculoskeletal discomfort
Clinical narrative: Information has been received from a health professional concerning a 14 year old white female (115.4 pounds, 63 inches) with seasonal allergies who on 16-Aug-2007 was vaccinated IM with Gardasil (lot #658490/0802U).  On 05-Sep-2007 the patient visited the physician's office with a fever, sore back, headache, vomiting and joint discomfort.  ANA, ASO, urine "C and S" were negative (not further specified).  The patient had her second IM injection, in the left arm, of Gardasil (lot #659435/1265U) on 24-Oct-2007 and on 28-Oct-2007 began to experience the same symptoms except without vomiting.  Subsequently she recovered.  Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Red blood cell count, Streptococcal identification test, Vomiting, White blood cell count increased
Clinical narrative: Information has been received from a health professional concerning a 14 year old white female (115.4 pounds, 63 inches) with seasonal allergies who on 16-Aug-2007 was vaccinated IM with Gardasil (lot #658490/0802U).  On 05-Sep-2007 the patient visited the physician's office with a fever, sore back, headache, vomiting and joint discomfort.  ANA, ASO, urine "C and S" were negative (not further specified).  The patient had her second IM injection, in the left arm, of Gardasil (lot #659435/1265U) on 24-Oct-2007 and on 28-Oct-2007 began to experience the same symptoms except without vomiting.  Subsequently she recovered.  Additional information is not expected.
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Pyrexia, Urticaria
Clinical narrative: Information has been received from a physician assistant (P.A.) concerning a female who was vaccinated with GARDASIL (lot# not reported). Concomitant therapy included MENACTRA, administered the same day. The injections were given in the same arm. Subsequently the patient experienced considerable fever (temperature not reported) and a "welt type reaction" in her arm. It was not known if the patient required hospitalization or other treatment. Outcome was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on approximately 23-OCT-2007 about 2 weeks ago, was vaccinated IM with a second 0.5mL dose of GARDASIL. On approximately 23-OCT-2007, the patient fainted after receiving the vaccine. Unspecified medical attention was sought. Within minutes and without any intervention at the office, the patient recovered. It was reported that the patient did not experience any events after her first dose of the vaccine. No product quality was involved. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a health professional concerning a 20 year old female with a history of drug hypersensitivity to Erythromycin who on 26-JUL-2007 was vaccinated intramuscularly with her first dose of Gardasil (Lot #657006/0188U).  Concomitant therapy included influenza virus vaccine (unspecified), venlafaxine HCl (Effexor) and ethinyl estradiol/norgestimate (Ortho Tri-Cyclen).  On 26-JUL-2007 the patient experienced pain at injection site.  The patient sought unspecified medical treatment while at the office.  On 06-NOV-2007 the patient was intramuscularly vaccinated with the second dose of Gardasil (Lot #659437/1266U) and experienced pain at the injection site.  Subsequently, the patient recovered from the pain at the injection site.  Additional information has been requested.  This is one of several reports received from the same source. This is in follow-up to report (s) previously submitted on 12/14/2007.