chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Rotavirus infection
Clinical narrative: Information has been received from a physician concerning a patient (age not reported) who on an unspecified date was vaccinated with orally 2 ml of ROTATEQ (orally dose and lot number not reported).  The physician reported that the patient developed ROTATEQ after receiving ROTATEQ.  The physician mentioned that the patient may had been "incubating rotavirus prior to vaccination".  At the time of the report the patient recovered on an unspecified date.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 0.52
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a 7 month old female patient who on 30-MAR-2009, 07-AUG-2009 and on 21-AUG-2009 was vaccinated with the first, second and third doses of ROTATEQ (Lot # 663265/1585X: first and second doses) (Lot #663848/0147Y: third dose). No adverse symptoms noted. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, PPV, RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a consumer her son, an 8 week old male patient with a history of premature birth 8 weeks early and no drug reactions/allergies who on 29-JUN-2009 was vaccinated with his first series of vaccinations which included ROTATEQ, HIB (OMPC) (manufacturer unknown), RECOMBIVAX HB (manufacturer unknown), DTaP vaccine (unspecified) (manufacturer unknown). Later that day, the patient began experiencing diarrhea in every diaper he had about 8 diapers a day and this experience lasted over 2 weeks. The patient had visited the office to seek medical attention. No laboratory diagnostic study was performed. On approximately 20-JUL-2009 (reported as "about 3 weeks after beginning of experience"), the patient recovered. Follow-up information received from the office indicated that no patient's specific information was found. Additional information is not expected.
Age: 0.1
Sex: M
Vaccine: HEP, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 30 day old male patient who on 19-AUG-2009 was vaccinated with a dose of ROTATEQ and RECOMBIVAX HB. No adverse effect reported. The patient sought unspecified medical attention. Additional information has been requested.
Age: 0.19
Sex: F
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 10 week old female patient who on 31-AUG-2009 was vaccinated with first dose of ROTATEQ (lot# not reported) at a wellness clinic. On 31-AUG-2009 within minutes the patient had large amount of emesis. Unspecified medical attention was sought. At the time of this report,  the patient's outcome was unknown. No further information is available.
Age: 0.0
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning an 18 day old male patient who on 11-SEP-2009 was vaccinated with a dose of ROTATEQ (lot number not reported).  Concomitantly the patient received a dose of PEDVAXHIB (manufacturer unspecified), a dose of PREVNAR, DTAP and IPOL.  No adverse effect reported.  Additional information has been requested.
Age: 1.16
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a licensed practical nurse concerning a 52 weeks old patient who on 11-SEP-2009 was vaccinated with the first and only dose of ROTATEQ.  No adverse effect reported.  It was unknown if the patient sought medical attention.  Follow up information received from the licensed practical nurse indicated that he was a 52 weeks patient with no known allergies or illnesses at time of vaccination.  Concomitant therapy included a second dose of FLUZONE (Lot # V3211AA) given on 11-SEP-2009 intramuscularly.  No diagnostic tests were performed.  No adverse event was reported.  Additional information has been requested.
Age: 0.16
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a medical assistant concerning a 2 month old female with relevant medical history or past drug history reported as none who on 16-MAR-2009 was vaccinated with a single dose of ROTATEQ (lot # 662825/1168X) orally.  There was no concomitant medication.  On 16-MAR-2009 the patient was in for a well baby appointment.  That night after getting the ROTATEQ she had diarrhea.  It was unknown if there was any relevant laboratory data.  As of 11-SEP-2009 she had not had any more doses of the ROTATEQ due to her mother's refusal, and she recovered from the diarrhea on an unknown date.  Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Regurgitation, Retching, Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning a 60 day old female patient who on 11-MAY-2009 was vaccinated orally with the first dose of ROTATEQ (Lot # 663265/1585X). On 14-JUL-2009 the patient was vaccinated orally with the second dose of ROTATEQ (Lot # 663461/0285Y). On 14-SEP-2009 the patient was vaccinated orally with the third dose of ROTATEQ (Lot #663848/0147Y) and regurgitated it 1-2 minutes later. The patient received a partial 4th dose of ROTATEQ (Lot # 663848/0147Y) on 14-SEP-2009. The patient started gagging so the full 4th dose was not given. The nurse practitioner mentioned the patient gagged after receiving the first and second dose but did not vomit the doses. The patient had sought medical attention, in the office. At the time of the report the patient's status was recovered. Follow-up information has been received from a physician indicated that the female patient with no illness at time of vaccination and with no pre-existing allergies, birth defects and medical conditions who was vaccinated with the third dose of ROTATEQ (Lot # 663848/0147Y) orally on 14-SEP-2009 at the age of 26 weeks old. The patient also was vaccinated with third dose of PENTACEL (Lot# C3362AA) in the left anterior lateral thigh on 14-SEP-2009 and the third dose of PREVNAR (Lot # 181705) in the right anterior lateral thigh on 14-SEP-2009. On 14-SEP-2009 at 10:00am the child gagged an unnoted dose of ROTATEQ. There were attempts to repeat dose to the child and the child gagged and spit out vaccine again. There were no respiratory problems and no distress. The patient had not sought medical attention. There were no relevant diagnostic tests. At the time of report the patient's status was recovered. Follow-up information has been received from a physician indicated that the female patient with no illness at time of vaccination and with no pre-existing allergies, birth defects and medical conditions who was vaccinated with third dose of ROTATEQ (lot# 663848/0147Y) orally on 14-Sep-2009 at 10:30 am. The patient also was vaccinated with the third dose of PENTACEL (Lot# C3362AA) IM in the left anterior lateral thigh on 14-SEP-2009 and the third dose of PREVNAR (Lot# D181705) IM in the right anterior lateral thigh on 14-SEP-2009. On 14-SEP-2009 at 10:30 am after ROTATEQ was given the patient immediately vomited. There were attempts to repeat dose to the child and the child vomited and spit out vaccine again. The patient had not sought medical attention. There were no relevant diagnostic tests. At the time of report the patient's status was recovered. Additional information is not expected.
Age: 0.34
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Screaming
Clinical narrative: Information has been received from a physician concerning an approximate 17 weeks old patient who on 15-Jun-2009 was vaccinated with the second dose of ROTATEQ. After the second dose of ROTATEQ, the patient developed diarrhea and screaming. Therapy with ROTATEQ was discontinued. At the time of the report the patient's status was unspecified. Additional information has been requested.
Age: 0.37
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 19 weeks patient who on 18-SEP-2009 was vaccinated with the first dose of ROTATEQ.  The physician thought the patient had received the first dose of ROTATEQ at age 2 months but did not.  The patient did not experience any known symptoms.  Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Regurgitation
Clinical narrative: Information has been received from a nurse concerning a patient who on 21-SEP-2009 was vaccinated with the second dose of ROTATEQ (lot number not reported) and spit up some of the medication.  There were no adverse reactions reported.  At the time of the report, the outcome of the patient was not reported.  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 consumer concerning her 19 weeks old son who on an unspecified date was vaccinated with ROTATEQ (Lot number was not provided) at 19 weeks old.  No adverse effects were reported.  No further information is available.
Age: 0.19
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Ultrasound scan, Vomiting
Clinical narrative: Information has been received from a medical assistant concerning a 9 weeks female patient with no known drug allergies and no pertinent medical history, who on 06-JUL-2009 was vaccinated orally with a dose of ROTATEQ.  Concomitant therapy included PENTACEL and PREVNAR which were administered on the same day.  There was no other concomitant therapy.  According to the reporter, on 06-JUL-2009 the patient experienced vomiting and diarrhea after administration of ROTATEQ.  The patient was examined in the emergency room but was not admitted.  At the time of the reporting the patient had recovered.  An ultrasound was performed (not results provided).  Additional information has been requested.
Age: 0.55
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning a 26 week old patient who on 22-APR-2009 was vaccinated with the first dose of ROTATEQ.  On 17-AUG-2009 the patient was vaccinated with the second dose of ROTATEQ.  The patient did not receive a third dose.  No adverse effect was reported.
Age: 0.16
Sex: F
Vaccine: RV5
Symptoms: Infantile spitting up
Clinical narrative: Information has been received from a licensed practical nurse concerning an infant who was vaccinated with a dose of ROTATEQ.  The nurse reported that the infant spat out a dose of ROTATEQ.  No adverse effect reported.  Follow up information has been received from a licensed practical nurse concerning a 3 month old female patient with birth weight of 5 pounds and 11 ounces who on 01-OCT-2009, at 4:15PM, was vaccinated orally with a first dose of ROTATEQ (lot # 664068/0319Y).  The patient spat up 10 minutes after receiving the dose of ROTATEQ.  The patient was known to have spitting up on a regular basis.  On the same day, the patient recovered.  Additional information is not expected.
Age: 0.9
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning her "11 months" old daughter who on an unspecified date was vaccinated orally with her 2 ml second dose of ROTATEQ.  According to the reporter, after receiving the second dose of ROTATEQ the patient experienced 16 days of diarrhea.  At the time of the report the patient had recovered.
Age: 0.37
Sex: F
Vaccine: RV5
Symptoms: Decreased appetite, Incorrect route of drug administration, Pyrexia
Clinical narrative: Information has been received from a physician concerning a patient who on 06-OCT-2009 was vaccinated with a second dose of ROTATEQ intramuscularly rather than oral administration.  The patient was kept in the office for an additional ten minutes with no reported problems.  The patient was not experiencing any known symptoms.  Follow-up information was received from a health care professional, concerning a female patient with no illnesses at the time of vaccination and no medical history, (birth weight reported 24.26 grams), who was vaccinated with a second dose of ROTATEQ (lot # 663839/0316Y), batch # 0316Y) into the left leg.  On the same day, the patient experienced fever and loss of appetite.  No laboratory diagnostics tests were performed.  On 08-OCT-2009, the patient had recovered.  No further information is available.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a medical assistant concerning a 5 month old patient who on an unspecified date was vaccinated PO with a 21 ml dose of ROTATEQ (lot number not reported).  It was unknown if medical attention was sought.  The outcomes of the patients were not reported.  Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Blood glucose normal, Breath sounds abnormal, Constipation, Decreased appetite, Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 60 day old female infant with umbilical hernia and a history of breathing difficult, heart rate irregular and premature baby who on 24-Nov-2008 was vaccinated with RECOMBIVAX HB. Concomitant therapy included vaccination with RECOMBIVAX HB (MSD) on 29-Jan-2009 and 26-Mar-2009. On 22-Jan-2009, the patient was seen in the physicians office because she experienced "gasps for air", difficulty swallowing and was constipated. It was reported that the patient had "intermittent problems breathing, making a noise breathing in/out all of the time. When she wakes up in the morning and into night occurring when she was awake and asleep." The pain was to monitor the patient for now, if the breathing problem progressed to contact the physician. The patient was to be recheck in one week. On 29-Jan-2009, at the patient's 2 month check-up, it was reported that the patient experienced diarrhea. On 18-Feb-2009, the patient experienced upper respiratory tract infection. It was reported that the patient was sleeping a lot the past 3 days. The patient's mother was concerned as the patient only wakes to eat and her appetite was decreased. It was also reported that the patient has been congested for the past 2 weeks. Laboratory/diagnostic tests performed at this time showed pulse oximetry at 100%, glucose at 84 and metabolic panel was normal. Instructions were provided for administration of saline nasal spray as treatment. On 26-Mar-2009, the patient experienced labial fusion. The patient was treated with PREMARIN CREAM), three times a day for 7 days, two times a day for 3 days, once a day for 2 days and then Vaseline daily. A follow-up appointment was recommended for 2 months. At the time of reporting, the outcome and causality for the events was unknown. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Dysphagia, Dyspnoea, Genital labial adhesions, Hypersomnia, Metabolic function test normal
Clinical narrative: Information has been received from a physician concerning a 60 day old female infant with umbilical hernia and a history of breathing difficult, heart rate irregular and premature baby who on 24-Nov-2008 was vaccinated with RECOMBIVAX HB. Concomitant therapy included vaccination with RECOMBIVAX HB (MSD) on 29-Jan-2009 and 26-Mar-2009. On 22-Jan-2009, the patient was seen in the physicians office because she experienced "gasps for air", difficulty swallowing and was constipated. It was reported that the patient had "intermittent problems breathing, making a noise breathing in/out all of the time. When she wakes up in the morning and into night occurring when she was awake and asleep." The pain was to monitor the patient for now, if the breathing problem progressed to contact the physician. The patient was to be recheck in one week. On 29-Jan-2009, at the patient's 2 month check-up, it was reported that the patient experienced diarrhea. On 18-Feb-2009, the patient experienced upper respiratory tract infection. It was reported that the patient was sleeping a lot the past 3 days. The patient's mother was concerned as the patient only wakes to eat and her appetite was decreased. It was also reported that the patient has been congested for the past 2 weeks. Laboratory/diagnostic tests performed at this time showed pulse oximetry at 100%, glucose at 84 and metabolic panel was normal. Instructions were provided for administration of saline nasal spray as treatment. On 26-Mar-2009, the patient experienced labial fusion. The patient was treated with PREMARIN CREAM), three times a day for 7 days, two times a day for 3 days, once a day for 2 days and then Vaseline daily. A follow-up appointment was recommended for 2 months. At the time of reporting, the outcome and causality for the events was unknown. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Oxygen saturation normal, Upper respiratory tract congestion, Upper respiratory tract infection
Clinical narrative: Information has been received from a physician concerning a 60 day old female infant with umbilical hernia and a history of breathing difficult, heart rate irregular and premature baby who on 24-Nov-2008 was vaccinated with RECOMBIVAX HB. Concomitant therapy included vaccination with RECOMBIVAX HB (MSD) on 29-Jan-2009 and 26-Mar-2009. On 22-Jan-2009, the patient was seen in the physicians office because she experienced "gasps for air", difficulty swallowing and was constipated. It was reported that the patient had "intermittent problems breathing, making a noise breathing in/out all of the time. When she wakes up in the morning and into night occurring when she was awake and asleep." The pain was to monitor the patient for now, if the breathing problem progressed to contact the physician. The patient was to be recheck in one week. On 29-Jan-2009, at the patient's 2 month check-up, it was reported that the patient experienced diarrhea. On 18-Feb-2009, the patient experienced upper respiratory tract infection. It was reported that the patient was sleeping a lot the past 3 days. The patient's mother was concerned as the patient only wakes to eat and her appetite was decreased. It was also reported that the patient has been congested for the past 2 weeks. Laboratory/diagnostic tests performed at this time showed pulse oximetry at 100%, glucose at 84 and metabolic panel was normal. Instructions were provided for administration of saline nasal spray as treatment. On 26-Mar-2009, the patient experienced labial fusion. The patient was treated with PREMARIN CREAM), three times a day for 7 days, two times a day for 3 days, once a day for 2 days and then Vaseline daily. A follow-up appointment was recommended for 2 months. At the time of reporting, the outcome and causality for the events was unknown. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Insomnia, Joint instability, Myalgia
Clinical narrative: Information has been received from a Medical Technologist (M.T.) concerning a 58 year old female patient with no pertinent medical history and no known drug allergies/drug reactions who on 03-DEC-2008 was vaccinated with the first 1 mL dose of RECOMBIVAX HB intramuscularly.  On 07-MAY-2009 the patient received the third 1 mL dose of RECOMBIVAX HB (Lot # 663315/1446X) (Thimerosal Free) intramuscularly.  There was no concomitant medication reported.  It was reported that on 09-MAY-2009 the patient developed joint aching, muscle aching and insomnia.  The patient also noticed her "elbow joints popping".  The patient sought medical attention via telephone call.  It was reported that the patient was recommended to take ALEVE.  There were no laboratory diagnostic tests performed.  It was reported that the patient had not recovered at the time of the report.  Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Chronic fatigue syndrome, Fatigue, Vestibular neuronitis
Clinical narrative: Information has been received concerning a male diagnosed with mononucleosis (early 2001) who on 05-NOV-2001 was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown). Two doctors retained by the petitioners opined that the patient had recovered from the Epstein Barre infection before the 05-NOV-2001, hepatitis B vaccination in question, while two doctors retained by the respondent opined the patient continued to show signs of Epstein Barr infection for months later. His mother testified that he experienced certain problems the evening he received the vaccine, but she did not consult a doctor. No contemporaneous medical record supported the mother's descriptions of his problems. He went to the emergency room on 03-NOV-2001, where doctors eventually diagnosed him with vestibular neuronitis. In early 2002, he complained of fatigue and he was eventually diagnosed with chronic fatigue syndrome. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: HEP
Symptoms: Guillain-Barre syndrome
Clinical narrative: Information has been received from a physician concerning a now 18 year old female who in approximately 1997, when she was 6 years of age, was vaccinated with RECOMBIVAX HB (manufacturer unknown). In approximately 1997, when she was 6 years of age, after vaccination, the patient experienced GUILLAIN-BARRE syndrome and was hospitalized. Date of hospitalization and hospital's name were unknown. The physician did not want to report the event because it happened a long time ago, it was already reported and she did not have the patient's chart. No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Swelling, Vaccination complication
Clinical narrative: Information has been received from a medical assistant concerning a female with allergy to penicillin, eggs, sulfa and yeast who was vaccinated with RECOMBIVAX HB (manufacturer unspecified). Subsequently the patient experienced severe reaction involving swelling after she received the vaccine. This occurred "years ago" and was not administered by the office where the medical assistant worked. The patient sought medical attention by unspecified contact. Subsequently, the patient recovered. Additional information has  been requested.
Age: 0.53
Sex: M
Vaccine: RV5
Symptoms: Abnormal faeces, Diarrhoea, Faeces discoloured
Clinical narrative: Information has been received from a consumer concerning her 6 months old grandson who was taking "alimentum due to lactose intolerance and "something for reflux" who between 20-May-2009 and 25-May-2009 was vaccinated orally with his first dose of ROTATEQ, on an unspecified date received his second dose of ROTATEQ and on 06-Oct-2009 received orally his third dose of ROTATEQ. Concomitant therapy included "something for the reflux, maybe PRILOSEC", and other unspecified vaccines "that were due at 6 months of age but they were not live vaccines". According to the reporter, the patient received his third dose of ROTATEQ and on 07-Oct-2009 had horrible smelling dark bowel movements. It was also reported that the stools were soft and very loose but not runny and green in color. The grandson had 2-5 bowel movements every day. The reporter also stated there was no fever. The pediatrician office told the mother of the patient on 08-Oct-2009 that it was probably rotavirus. The reporter stated that the consumer had no problems with the first or second dose of ROTATEQ. At the time of the report the patient had not recovered. No diagnostic tests were performed. Additional information has been requested.
Sex: M
Vaccine: RV5
Symptoms: Expired drug administered, Pyrexia
Clinical narrative: Information has been received from a physician and a mother concerning her son who on 13-OCT-2009 was vaccinated with the third dose of ROTATEQ (Lot No. not provided) that had expired on 25-SEP-2009.  The mother reported that her son also received several unspecified vaccines at the same time as ROTATEQ and that her son had a
Age: 0.36
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received form a health professional concerning a 4 month old patient who on 04-NOV-2008 was vaccinated late with ROTATEQ. On 14-JAN-2009 and 17-SEP-2009 the patient received the second and third dose ROTATEQ respectively. The patient did not experience any known symptoms. At the time of this report, the patient outcome was unknown. Follow up information has been received form the nurse practitioner who indicated that a male patient with no known allergies or drug reactions and no pertinent medical history who on 17-SEP-2009 receive his third dose of ROTATEQ (Lot # 661430/1033X) PO at 14:00. There was no illness at the time of vaccination. No adverse event was reported. No labs or diagnostic tests were performed. No further information is available.
Age: 0.51
Sex: M
Vaccine: DTAPH, HEP, RV5
Symptoms: Decreased appetite, Expired drug administered, Rash
Clinical narrative: Information has been received from a registered nurse who was also the patient's mother and a consumer who was also the patient's father concerning their son, a 6month old patient with no drug reaction or allergy who on 16-JUN-2009 was vaccinated with the first dose of ROTATEQ vaccine. On 21-AUG-2009 the patient was vaccinated with second dose of ROTATEQ vaccine. On 12-OCT-2009 the patient was vaccinated with the third dose of 2 ml ROTATEQ vaccine (lot # 660287/1887U) which was expired with an expiration date of September 2009 (the full expiration date was unknown). Other concomitant therapy included amoxicillin. The father reported that after received the vaccine, on 13-OCT-2009 the patient's "appetite dropped drastically". Father stated that is was possible that his son wasn't eating when he was around, or that it might be related to an ear infection that he got "around the same time the vaccine was given". Mother of the child also reported that her son had a slight rash on his face. Her son was also given diphtheria toxoid (+) Hib conj vaccine (unspecified carrier) (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid three in one vaccine, and a hepatitis B (manufacturer unknown) on the same date of 12-OCT-2009. It was reported that adverse event appeared after reintroduction. No laboratory diagnostics study was performed. Unspecified medical attention had been sought. The outcome of the adverse events was unknown. The mother wanted all the follow up information sent to the physician and her. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient who on 22-OCT-2009 was vaccinated with a PO dose of ROTATEQ (Lot number unspecified) (It was not known which dose in th series this was). The licensed practical nurse reported that the patient may have received a partial dose of ROTATEQ. The patient vomited soon after the dose was administered. At the time of the report the status of the patient was unspecified. It was unknown if the patient sought medical attention. 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 16 week old female patient who on 28-OCT-2009 was vaccinated orally with first 2mL dose of ROTATEQ (lot number not reported).  The physician stated that on 28-OCT-2009, the patient came to the office for her 4 month well visit and was administered what they thought it was the second dose of ROTATEQ.  After looking at the patient's chart they realized that the patient had not been administered the first dose at 2 months old and that the dose given on 28-OCT-2009 was actually the first.  No adverse effect was involved.  Additional information has been requested.
Age: 0.49
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Rotavirus infection, Rotavirus test positive, Stool analysis abnormal, Vomiting
Clinical narrative: Information has been received from a nurse concerning a 13 month old male who on 05-NOV-2008, on 07-JAN-2009 and in March 2009 received orally 2ml the first, second and third doses respectively of ROTATEQ (lot number not reported).  Concomitant therapy included a dose of RECOMBIVAX HB, a dose of PREVNAR and a dose of PENTACEL on an unspecified date.  On 19-OCT-2009 the patient developed diarrhea and vomiting.  The physician's office performed a rotavirus test and they did it a micro slide analysis of the patient's stool and the patient tested positive for rotavirus.  The patient was doing fine as 28-OCT-2009.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 0.25
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 13 week old male patient with a history of gastrooesophageal reflux who on 31-OCT-2009 was vaccinated with the first dose of ROTATEQ (oral administration, "three times").  Concomitant therapy included MOTILIUM and RANIMED.  On 31-OCT-2009, the same night that the patient received the vaccine, the patient developed acute vomiting.  The vomiting sustained for 48 hours till he felt relief and recovered 48 hours later on 02-NOV-2009.  Additional information is not expected.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Regurgitation
Clinical narrative: Information has been received from a physician concerning an approximately 16 week old patient who was vaccinated orally with 1 pouch of ROTATEQ.  The physician reported that the patient regurgitated a portion of the ROTATEQ dose shortly after receiving it.  The physician also mentioned that it happened after the first dose.  It was unknown if the patient sought medical attention.  Additional information has been requested.
Age: 0.75
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 9 month old male patient who on 18-NOV-2009 was vaccinated with his third oral dose of ROTATEQ.  No adverse symptoms were reported.  Additional information has been requested.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a licensed nurse practitioner concerning a 19 weeks old male patient without any pertinent medical history, drug reactions or allergies, who on 03-SEP-2009 and on 02-NOV-2009 was vaccinated with the first and second dose of ROTATEQ respectively (oral route, lot # 664291/0769Y).  Concomitant therapy included PENTACEL and PREVNAR.  On approximately 05-NOV-2009, "3-4 days after receiving the second dose of ROTATEQ", the patient developed a rash on the trunk and possibly on the groin.  No lab diagnostic studies performed.  The patient sought medical attention in the physician's office.  At the time of the report the patient's outcome was unknown.  A standard lot check investigation has been finalized.  All in-process quality checks for the lot number 664291/0769Y in question were satisfactory.  The lot met the requirements of the Center for Biologics Evaluation and Research and was released.  Follow-up information has been received from a registered nurse via medical records concerning the 5 month old white male with eczema.  It was reported that on 03-SEP-2009 the patient received a first dose of ROTATEQ (lot # 664398/0573Y) and concomitantly received a first dose of PENTACEL into his left thigh (lot # C3436AB) and a first dose of PREVNAR into his left thigh (lot # D81705).  On 02-NOV-2009, the patient received a second dose of ROTATEQ (lot # 664291/0769Y) orally, and a second dose of PENTACEL (lot # C3482A) IM into his left thigh and a second of PREVNAR (lot # D90888) IM into his right thigh.  There was no illness at time of vaccination.  It was reported by the registered nurse that the patient was seen on 05-NOV-2009 with complaints of rash.  It was reported that the patient had a history of eczema but different from rash presented on 05-NOV-2009.  The patient used NUCORT as needed and AQUAPHOR twice a day.  On 06-NOV-2009, the rash had spread to patient cheeks and by 12-NOV-2009 the rash had almost gone. On 17-NOV-2009, the patient presented for follow-up and overall history and findings, suggested that the patient's viral infection was resolved.  The registered nurse reported that the patient's rash was not due to the vaccination.  No further information is available.
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a physician assistant concerning a male patient who on unspecified dates were vaccinated with "2 out of the 3 doses" of ROTATEQ (oral).  Subsequently the patient developed symptoms of ROTATEQ like vomiting and diarrhea that lasted for a couple of days.  At the time of the report, the patient recovered after a couple of days of having the symptoms.  No further information is available.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a nurse and a physician's assistant concerning a 8 weeks old female patient with no known drug allergies and a history of hospitalization and H1N1 virus who on 25-NOV-2009 was vaccinated with the first dose of ROTATEQ (lot # 662825/1168X) orally.  Concomitant therapy included PENTACEL (lot # 3498AA), PREVNAR (lot # D03125) and hepatitis B virus vaccine (lot # AHBVB707M) (manufacturer unspecified).  It was reported that 30 minutes after receiving ROTATEQ on 25-NOV-2009 the infant vomited.  On the same day the patient fully recovered from vomiting.  The patient sought unspecified medical attention.  No further information is available.
Age: 1.6
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a consumer concerning her 19 month old son who on 01-DEC-2009 was vaccinated with his first dose of oral ROTATEQ (lot # not given) despite being past the indicated age.  Follow up information received from physician indicating that the patient had no adverse effect.  No further information is available.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient who on 14-AUG-2009 was vaccinated with the first dose of ROTATEQ, on 30-SEP-2009 was vaccinated with the second dose of ROTATEQ and on 15-OCT-2009 was vaccinated with the third dose of ROTATEQ.  No adverse event was reported.  Additional information has been requested.
Age: 1.56
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning an 18 month old male with underweight who on 08-DEC-2009 morning was vaccinated with a dose of ROTATEQ (dose, route, and lot # not reported). No adverse effects reported. The patient sought medical attention through an office visit. Follow up information has been received from a registered nurse concerning an 18 month old male patient with no illness at the time of the vaccination who on 08-DEC-2009, at 9:30 am was vaccinated orally with first dose of ROTATEQ (lot# 664588/0613Y). Concomitant vaccination at the same time included a dose of PENTACEL (lot# C339SAA) (Sanofi Pasteur) in right deltoid, a dose of PREVNAR (lot# D93212) (Wyeth) in left deltoid, and a dose of FLUZONE (lot# U3260BA) (Sanofi Pasteur) in left deltoid. No adverse event reported. Additional information is not expected.
Age: 0.1
Sex: M
Vaccine: RV5
Symptoms: Diagnostic procedure, Diarrhoea, Incorrect route of drug administration, Irritability
Clinical narrative: Information has been received from a consumer concerning his 2 month old son who on 21-OCT-2009 was vaccinated intramuscularly with "single dose" of ROTATEQ.  Concomitant medication include "other vaccines for that age: unspecified which ones".  The baby had been fussy "after getting the vaccine" and experiencing diarrhea.  The baby was taken for some gastrointestinal test on 15-DEC-2009.  The baby was not hospitalized.  The patient's fussy and diarrhea persisted at the time of this report.  No further information is available.
Age: 0.42
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a licensed visiting nurse concerning an approximately 22 week old patient who on 17-NOV-2009 was inadvertently vaccinated with the first dose of ROTATEQ outside the recommended age range.  No symptoms were reported.  It was unknown if the patient sought medical attention.  Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a medical assistant concerning a 2 month old male infant with no pertinent medical history who on 18-DEC-2009 was vaccinated orally with the first 2 ml dose of ROTATEQ (lot # not reported).  Concomitant therapy included "other routine 2 month of age vaccines".  On 18-DEC-2009 the patient "vomited" after receiving the dose of ROTATEQ in the physician's office.  No diagnostic laboratory test was performed.  At the time of the report, the patient's status was unknown.  No further information is available.
Age: 1.5
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a medical technologist concerning an 18 month old male who was vaccinated with ROTATEQ today.  There were no adverse effects reported.  Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: No adverse event
Clinical narrative: Information has been received from a registered nurse concerning an approximately 16 week old patient who on approximately 11-JAN-2010 ("last week"), was vaccinated with dose of ROTATEQ. Concomitant therapy included globulin, immune. The patient did not experience any known symptoms. It is unknown if the patient sought medical attention. 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 was vaccinated with the first dose of ROTATEQ at age 2 months and the second dose at age 6 months.  The patient stated that the patient was over 8 months of age at the reporting time and would not be able to receive the third dose.  No adverse reactions reported.  At the time of report, the outcome was unknown.  Additional information has been requested.  This is one of two reports received from the same source.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, DTAPIPVHIB, HIBV, PNC, RV5
Symptoms: Diarrhoea, Diet refusal, Infantile spitting up, Irritability, Rotavirus infection
Clinical narrative: Information has been received from a physician (also reported as a nurse) concerning a 9 week old male with no pertinent medical history and no drug reactions/allergies who on 15-JAN-2010 was orally vaccinated with the first dose of ROTATEQ (2ml, lot # 663144/1449X). Concomitant therapy included PREVENAR, DTaP (unspecified) (-) Hib vaccine (unspecified carrier) and IPOL. The patient experienced diarrhea on 20-JAN-2010 and loose bowels on 21-JAN-2010. On 21-JAN-2010 the patient was also fussy, spitting up and not eating. The patient was seen in the office and a stool specimen was sent to the lab on 21-JAN-2010. The lab report was positive for rotavirus. At the time of report the patient had not recovered. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, DTAPIPVHIB, HIBV, PNC, RV5
Symptoms: Rotavirus test positive
Clinical narrative: Information has been received from a physician (also reported as a nurse) concerning a 9 week old male with no pertinent medical history and no drug reactions/allergies who on 15-JAN-2010 was orally vaccinated with the first dose of ROTATEQ (2ml, lot # 663144/1449X). Concomitant therapy included PREVENAR, DTaP (unspecified) (-) Hib vaccine (unspecified carrier) and IPOL. The patient experienced diarrhea on 20-JAN-2010 and loose bowels on 21-JAN-2010. On 21-JAN-2010 the patient was also fussy, spitting up and not eating. The patient was seen in the office and a stool specimen was sent to the lab on 21-JAN-2010. The lab report was positive for rotavirus. At the time of report the patient had not recovered. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, DTAPIPVHIB, HIBV, PNC, RV5
Symptoms: Diarrhoea, Rotavirus infection, Rotavirus test positive, Vomiting
Clinical narrative: Information has been received from a physician (also reported as a nurse) concerning a 9 week old male with no pertinent medical history and no drug reactions/allergies who on 15-JAN-2010 was orally vaccinated with the first dose of ROTATEQ (2ml, lot # 663144/1449X). Concomitant therapy included PREVENAR, DTaP (unspecified) (-) Hib vaccine (unspecified carrier) and IPOL. The patient experienced diarrhea on 20-JAN-2010 and loose bowels on 21-JAN-2010. On 21-JAN-2010 the patient was also fussy, spitting up and not eating. The patient was seen in the office and a stool specimen was sent to the lab on 21-JAN-2010. The lab report was positive for rotavirus. At the time of report the patient had not recovered. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, DTAPIPVHIB, HIBV, PNC, RV5
Symptoms: Diarrhoea, Diet refusal, Infantile spitting up, Irritability, Rotavirus infection
Clinical narrative: Information has been received from a Registered Nurse (R.N) concerning an 8 weeks old white male patient who on 15-JAN-2010, at 11:00 am, was vaccinated with the first dose of ROTATEQ (Lot # 663144/1449X) by oral route.  Concomitant vaccines given intramuscularly on the same day, at 11:00 am, included the first dose of PREVENAR (Lot # D59304), the first dose of ACTHIB (Lot # 4F708AA), the first dose of TRIPEDIA (Lot # 424708A) and PENTACEL (Lot # D0052).  It was reported that on 21-JAN-2010, at 06:00 am, the patient started with diarrhea 6 days after immunization.  The patient started with vomiting and has had no fever.  On an unspecified date a rotavirus serology test was performed and it showed a positive results.  The patient sought medical attention with a doctor visit.  At the time of the report the outcome of the patient was unknown.  Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, DTAPIPVHIB, HIBV, PNC, RV5
Symptoms: Rotavirus test positive
Clinical narrative: Information has been received from a Registered Nurse (R.N) concerning an 8 weeks old white male patient who on 15-JAN-2010, at 11:00 am, was vaccinated with the first dose of ROTATEQ (Lot # 663144/1449X) by oral route.  Concomitant vaccines given intramuscularly on the same day, at 11:00 am, included the first dose of PREVENAR (Lot # D59304), the first dose of ACTHIB (Lot # 4F708AA), the first dose of TRIPEDIA (Lot # 424708A) and PENTACEL (Lot # D0052).  It was reported that on 21-JAN-2010, at 06:00 am, the patient started with diarrhea 6 days after immunization.  The patient started with vomiting and has had no fever.  On an unspecified date a rotavirus serology test was performed and it showed a positive results.  The patient sought medical attention with a doctor visit.  At the time of the report the outcome of the patient was unknown.  Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, DTAPIPVHIB, HIBV, PNC, RV5
Symptoms: Diarrhoea, Rotavirus infection, Rotavirus test positive, Vomiting
Clinical narrative: Information has been received from a Registered Nurse (R.N) concerning an 8 weeks old white male patient who on 15-JAN-2010, at 11:00 am, was vaccinated with the first dose of ROTATEQ (Lot # 663144/1449X) by oral route.  Concomitant vaccines given intramuscularly on the same day, at 11:00 am, included the first dose of PREVENAR (Lot # D59304), the first dose of ACTHIB (Lot # 4F708AA), the first dose of TRIPEDIA (Lot # 424708A) and PENTACEL (Lot # D0052).  It was reported that on 21-JAN-2010, at 06:00 am, the patient started with diarrhea 6 days after immunization.  The patient started with vomiting and has had no fever.  On an unspecified date a rotavirus serology test was performed and it showed a positive results.  The patient sought medical attention with a doctor visit.  At the time of the report the outcome of the patient was unknown.  Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 17 week old patient who was vaccinated with the first dose of ROTATEQ at age 4 months and the second dose at age 6 months.  The patient stated that the patient was over 8 months of age at the reporting time and would not be receiving the third dose.  No adverse reactions reported.  At the time of report, the outcome was unknown.
Age: 1.05
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old female who on 09-MAR-2009 and 02-JUN-2009 was vaccinated with a first and second doses of ROTATEQ (lot# not reported). The patient was seen for her 12 month appointment on 27-JAN-2010 and was inadvertently given a third dose of ROTATEQ. No adverse effects reported. The patient did not seek medical attention. Additional information has been requested.
Age: 0.1
Sex: F
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a medical assistant concerning an 8 week old female patient who on 01-JUL-2009 was vaccinated with a recommended dose of ROTATEQ (lot number not reported) via oral administration.  On 08-JUL-2009, the patient experienced vomiting after receiving vaccine.  The patient had sought medical attention by calling the office.  On 09-JUL-2009, the patient recovered from vomiting.  Additional information has been requested.
Age: 0.79
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 9 month old female patient who on 07-JUL-2009 was vaccinated with a third 2ml dose of ROTATEQ (663711/0107Y) orally.  No adverse effects were reported.  It was unknown if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with a second 2ml dose of ROTATEQ (lot number not reported) orally earlier than 6 weeks.  There was no information on first dose.  No adverse effect was involved.  It was unknown if the patient had sought medical attention.  Additional information has been requested.
Age: 0.9
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a 11 month old patient who on unspecified date was vaccinated orally with the second 2.0 mL dose of ROTATEQ (Lot # 663711/0107Y). No adverse effect was reported. This is one of several cases from the same source. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a consumer concerning his daughter, an 8 week old female patient with no pertinent medical history and drug reaction / allergies who on 13-JUL-2009 was vaccinated with a dose of ROTATEQ orally.  There was no concomitant medication.  On 13-JUL-2009, soon after receiving vaccine, the patient vomited up the vaccine.  The patient had sought medical attention in the clinic.  No lab diagnostic study was performed.  Subsequently, the patient recovered on 13-JUL-2009.  This is one of several reports received from the same source.  No further information is available.