chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Heart rate increased, Muscular weakness, Tremor
Clinical narrative: 20 minutes after I was given the Influenza shot I was feeling very dizzy and felt like passing out, my heart rate elevated to 164/87 and my normal is  104/62. I was shaking all over and was taken to ER. I was given Epinephrine and hooked up to a heart monitor because my heart was skipping a beat. Went home 3 hours later still could not breathe well and was very dizzy. Went to ER again that night and was told they could not find anything and to continue to take Benadryl this continued for the next month and have been to ER 4 times total and to the clinic, Neurologist and Allergy specialist several times. I was out of work for 3 months because of trouble breathing, dizziness and weakness of arms and legs. I was given Prozac. Zoloft. Ativan, and Allegra during this time stopped taking medications and went to work on 2/16. 3/13 still not feeling like I did before having the shot. Still feeling light headed and dizzy.
Age: 0.33
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Petechiae
Clinical narrative: 10 minutes after child received DTAP, COMVAX, IPV and Prevnar and Rotateq po, petechiae noted on neck and face. No symptoms of dizziness. Doctor made aware.
Age: 33.0
Sex: M
Vaccine: TYP
Symptoms: Blister, Injection site oedema, Local reaction, Pyrexia, Type III immune complex mediated reaction
Clinical narrative: Developed severe local reaction along outside of the arm from shoulder to fingers. Also developed fever and blisters on area "like a bad sunburn". Probable arthus reaction.  Edema at injection site >120 mm beyond elbow. Fever.
Age: 0.11
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Rotavirus test
Clinical narrative: Information has been received from a pharmacist concerning a 44-day-old male with no allergies who was hospitalized due to abdominal surgery for gastroschisis repair (at birth) who on 29-JAN-2007 was vaccinated with the first dose of Rotateq. There was no concomitant therapy. The pharmacist reported that on 31-JAN-2007, the patient developed diarrhea. Unspecified medical attention was sought. On 04-FEB-2007, one week after being discharged after gastroschisis repair, the patient was hospitalized for the diarrhea. While hospitalized, the patient was treated with IV fluids and a stool sample was tested for rotavirus (results not provided). At the time of this report, the patient was noted to be recovering. No further information is available.
Age: 0.48
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a 5-month-old male who on 24-OCT-2006 and February 2007 was vaccinated PO with the first and second doses, respectively, of Rotateq. Unspecified medical attention was sought. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Rotavirus test, Rotavirus test positive, Vomiting
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated PO with a dose of rotavirus. The physician reported that, a week after being vaccinated, the patient developed moderate vomiting and diarrhea. Unspecified medical attention was sought. A stool sample was positive for rotavirus. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 0.45
Sex: M
Vaccine: HIBV, PNC, RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a physician concerning an approximately 2-month0old male with no medical history or allergies who on 31-OCT-2006 was vaccinated PO with the first dose of Rotateq. The physician reported that after being vaccinated the patient developed intermittent diarrhea and vomiting for a month (exact start date of symptoms unknown). Unspecified medical attention was sought. No laboratory/diagnostic test were performed. On 23-JAN-2007, the patient was vaccinated PO with the second dose of Rotateq. Concomitant vaccinations administered on that same day included a dose of PedvaxHib and a dose of Prevnar. On 28-JAN-2007, the patient again developed vomiting and diarrhea. The patient subsequently recovered. Additional information has been requested.
Age: 0.41
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a 21-week-old patient who on 08-DEC-2006 was vaccinated PO with the first dose of Rotateq. On 08-FEB-2007, the patient was vaccinated PO with the second dose of Rotateq. Additional information has been requested.
Age: 0.53
Sex: F
Vaccine: DTAP, FLU3, PNC, RV5
Symptoms: Body temperature increased, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with the third dose of Rotateq. The physician reported that the patient subsequently experienced a fever of 104 degrees. Unspecified medical attention was sought. The patient's fever subsequently resolved. Additional information has been requested. 06/01/2007 Information has been received from a physician concerning a 6-month-old female with no medical history who on 08-JAN-2007, at 1100, was vaccinated PO with the third dose of ROTATEQ (Lot #655174/0848P). Concomitant vaccinations adminstered on that same day and time included the third IM dose in the right thigh of PREVNAR (Lot #B08653H), the third dose in the left thigh of TRIPEDIA (Lot #U1813BA) and the first IM dose in the left thigh of FLUZONE (Lot #U2174DA). There was no illness at the time of vaccination. The physician reported that on 15-JAN-2007, the patient vomited x 1 and experienced a fever of 102-104 degrees. No other symptoms were reported. Unspecified medical attention was sought. No laboratory/diagnosic tests were performed. On 18-JAN-2007, the patient recovered. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 2-month-old patient who was vaccinated with a dose of Rotateq. The physician reported that the patient subsequently developed diarrhea. Unspecified medical attention was sought but no laboratory/diagnostic tests were performed. The patient subsequently recovered. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a health professional concerning a patient who on 19-OCT-2006 was vaccinated with a first dose of Rotateq. It was reported that on 12-FEB-2007 the patient would be coming into the office for a second dose of Rotateq. No symptoms had been reported. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Accidental exposure, Nausea, Vomiting
Clinical narrative: Information has been received from a registered nurse who on 11-SEP-2006 had an infant spit up some Rotateq which dribbled down her arm. The RN subsequently washed her arm off. The RN reported than on 12-SEP-2006, at about 0500, she developed severe nausea and vomiting for about 12 hours. Unspecified medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Accidental exposure, Diarrhoea, Vomiting
Clinical narrative: Information has been received from an office worker concerning a female nurse who developed diarrhea and vomiting after administering rotavirus to a patient. The nurse was subsequently hospitalized (duration unknown). It was not know if the nurse had any direct contact with the vaccine or if the patient she was vaccinating spit out the vaccine after it was administered. At the time of this report, the nurse's diarrhea and vomiting persisted. Additional information has been requested.
Age: 0.25
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a physician concerning a 16-week-old patient who was vaccinated with the first dose of Rotateq. It was unknown if medical attention was sought. No symptoms were reported. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a physician concerning several patients who were vaccinated with the first dose of Rotateq at 4 months of age. It was unknown if medical attention was sought. No adverse event was reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Age: 0.35
Sex: F
Vaccine: RV5
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: Information has been received from a nurse concerning an 18-week-old female who on 12-FEB-2007 was vaccinated with the Second 2.0 ml dose of Rotateq (Lot #653661/0146F). The nurse reported that on 12-FEB-2007, the patient developed a high fever of 102.7. Unspecified medical attention was sought. At the time of this report the patient's high fever persisted. Additional information has been requested.
Age: 0.12
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a female between 6-7 weeks old who, "within the last week," on approximately 06-Feb-2007, was vaccinated with a first oral dose of Rotateq. "Within the first five days," on approximately 06-Feb-2007, the patient developed diarrhea. It was reported that the diarrhea was mild. Subsequently, the patient recovered. There was no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, RV5
Symptoms: Gastroenteritis rotavirus, Secondary transmission
Clinical narrative: Information has been received from a physician concerning an approximately 9 month old female who was vaccinated with a first, second, and third oral dose of Rotateq on 08-Jun-2006, 25-Aug-2006, and 20-Oct-2006, respectively. Concomitant vaccine included a first, second, and third dose of Pediarix administered on the same dates, respectively.  "About a week ago," on approximately 02 Feb 2007 the patient experienced rotavirus. The patient was in the emergency room but was not hospitalized. Subsequently the patient fully recovered. It was reported that the patient's father also came down with rotavirus, but did not have to be hospitalized. No product quality complaint was involved. No other information was provided. The patient's twin brother experienced rotavirus following vaccination with Rotateq. Additional information has been requested.
Age: 0.36
Sex: F
Vaccine: DPP, HIBV, RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 4 month old patient who was vaccinated PO with a second dose of Rotateq. Subsequently the patient experienced diarrhea that started 1-2 days after the vaccination. Unspecified medical attention was sought but no tests were performed. The patient recovered. The physician was uncertain if the diarrhea was related to the Rotateq. Additional information has been requested. Follow up information received from the physician indicated that the patient had "severe" diarrhea, 8-10 times per day for 48-60 hours. No additional information is expected.
Age: 0.16
Sex: F
Vaccine: RV5
Symptoms: Flushing, Vomiting projectile
Clinical narrative: Information has been received from a physician concerning a 2 month old female who was vaccinated PO with the first dose of Rotateq. The physician reported that the patient's face turned red and she developed projectile vomiting. Unspecified medical attention was sought. The patient subsequently recovered. Additional information has been requested.  This is in follow-up to report(s) previously submitted on 3/14/2007.  Information has been received from a physician and medical assistant concerning a 57-day-old female with no medical history who on 14-FEB-2007, at 1030, was vaccinated PO with the first dose of ROTATEQ (Lot #654795/1374F).  There was no illness at the time of vaccination.  On 14-FEB-2007, at 1030, the patient's face turned red and she developed projectile vomiting which contained large amounts of formula (patient was fed prior to vaccination) after the first drops of vaccine were administered.  The patient was burped and was given a few more drops of the vaccine.  In seconds, the patient turned red in the face and vomited even more.  Unspecified medical attention was sought.  No laboratory/diagnostic tests were performed.  The remainder of the vaccine was not given and the patient was administered four vaccines for her two month visit.  The patient subsequently recovered.  Additional information is not expected.
Age: 0.5
Sex: F
Vaccine: DPP, HEP, IPV, RV5
Symptoms: Constipation
Clinical narrative: Information has been received from a mother concerning her 6 month old daughter with an unremarkable medical history and no allergies who on 28 Sep 2006 was vaccinated PO with the first 2.0 mL dose of Rotateq. Concomitant vaccinations administered on that same day included a dose of poliovirus vaccine, a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and a dose of hepatitis B. The mother reported that on approximately 30 Sep 2006, her daughter became severely constipated. Unspecified medical attention was sought. No laboratory/diagnostic tests were performed. The patient's mother noted that her daughter received all three doses of Rotateq per the appropriate schedule with the third dose having been administered on 29 Jan 2007. At the time of this report, the patient remained severely constipated. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Constipation
Clinical narrative: Information has been received from a healthcare professional concerning a 2 month old female who was vaccinated PO with a dose of Rotateq. It was reported that the patient subsequently became constipated. Medical attention was not sought. At the time of this report, the patient's constipated persisted. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a patient who was vaccinated with a dose of Rotateq. The LPN reported that the patient subsequently developed diarrhea. It was unknown if medical attention was sought. At the time of this report, the outcome was unknown. No further information is available.
Sex: F
Vaccine: RV5
Symptoms: Gastrointestinal pain, Irritability
Clinical narrative: Information has been received from a physician concerning an "over 4 months" old female who was vaccinated PO with the second 2.0 mL dose of Rotateq (human bovine) (1st dose given at 2 months old). The physician reported that, a day or two after receiving the second dose, the patient experienced some intestinal pain. The patient was also noted to be very irritable, but no mention of diarrhea was made. Unspecified medical attention was sought. The patient subsequently recovered. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAP, IPV, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 2 month old female who was vaccinated PO with a dose of Rotateq. Concomitant vaccinations administered at the time included a dose of diphtheria toxoid (+) pertussis accellular vaccine (unspecified) (+)tetanus toxoid and a dose of poliovirus vaccine inactivated (unspecified). The physician reported that, within 36 hours of being vaccinated, the patient developed vomiting. It was unknown if medical attention was sought and the patient was not hospitalized. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DPP, HIBV, IPV, RV5
Symptoms: Crying, Screaming
Clinical narrative: Information has been received from a physician concerning a 2 month old patient who was vaccinated with a dose of Rotateq and began crying inconsolable for 4-5 hours after the dose was given. The patient recovered. Unspecified medical attention was sought. Additional information has been requested. Follow-up information from the physician indicated that the patient had persistent screaming until 6 pm. The exam was normal and the patient recovered the same day, on 05-FEB-2007.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with an oral dose of Rotateq. Subsequently the patient experienced severe diarrhea and was hospitalized overnight. It was noted that that patient had been in for follow-up with the pediatrician. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 0.35
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning an 18 week old female who on 27-DEC-2006 was vaccinated with a first dose of Rotateq. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a female who on 01-FEB-2007 was vaccinated with an oral dose of Rotateq. On 15-FEB-2007 the patient experienced vomiting. The vomiting lasted for four days. It was not specified if the patient had recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: RV5
Symptoms: Culture stool positive, Diarrhoea, Enterovirus infection
Clinical narrative: Information has been received from a physician concerning a 2 month old patient who on 09-FEB-2007 was vaccinated within oral dose of Rotateq (lot # 655866/1110F). On 09-FEB-2007 the patient developed diarrhea. The patient sought treatment for the diarrhea on 09-FEB-2007, 12-FEB-2007, 15-FEB-2007 and 19-FEB-2007. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.  This in in follow-up to report (s) previously submitted on 3/14/2007.  Information has been received from a physician concerning a 9 week old patient with a history of formula intolerance, colicky disposition and ventricular septal defect who on 09-FEB-2007 at 11:45 am was vaccinated with an first oral dose of ROTATEQ (lot # 655866/1110P).  There was no illness at the time of vaccination.  On 11-FEB-2007 (previously reported as 09-FEB-2007) the patient developed diarrhea.  The patient sought treatment for the diarrhea on 12-FEB-2007, 16-FEB-2007 and 19-FEB-2007 (09-FEB-2007 was previously reported as a treatment date).  The patient's diarrhea was described as non-specific without emesis.  There was no blood or mucous in the stool.  There was no weight loss.  On 21-FEB-2007 a stool culture was positive for enterovirus.  On 28-FEB-2007 the patient recovered.  There was no product quality complaint involved.  Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old male twin with a history of premature delivery who on 12-FEB-2007 at 14:30 was vaccinated with a PO first dose of Rotateq (lot # 656105/1232F). Concomitant vaccination administered that day at 14:30 included an IM first dose in the left thigh of Pediarix (lot # AC21B092AA), an IM first dose in the left thigh of ActHib (lot # UE704AA), and a first IM dose in the right thigh of Prevnar (lot # B08672K). On 12-FEB-2007 at 16:30 the patient developed diarrhea. A doctors visit was sought. There were no laboratory tests performed. Subsequently, the patient recovered from diarrhea on an unspecified date. There was no product quality complaint involved. It was reported that the patient's twin sister (WAES# 0703USA00869) experienced a similar event after vaccination with Rotateq (lot # 656105/1232F). Additional information is not expected.
Age: 0.17
Sex: M
Vaccine: HEP, RV5
Symptoms: Pyrexia, Urticaria
Clinical narrative: Information has been received from a physician concerning a 9 week old male who on 13-FEB-2007 was vaccinated with an oral first dose of Rotateq. Concomitant vaccination administered that day included a dose of Recombivax HB and a dose of Prevnar. On 19-FEB-2007 the patient developed perfuse bluish hives ranging from the torso and legs, spreading to face and arms. On 20-FEB-2007 the patient had a low grade fever (temperature unspecified). When the physician saw him on 21-FEB-2007, she noted that hives had reduced to just a few. The patient was considered to be recovering. There was no product quality complaint involved. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Giardiasis, Parasite blood test, Rotavirus test negative
Clinical narrative: Information has been received from a healthcare professional concerning a 6-month-old female with an allergy to milk protein who on 16-JAN-2007 was vaccinated PO with the first dose of Rotateq (Lot #655175/0849F). There was no concomitant therapy. It was reported that on 07-FEB-2007, the patient developed diarrhea. No fever was noted. On 09-FEB-2007, the patient was seen in the physician's office. A stool test was negative for rotavirus and positive for Giardia. The patient was treated with Flagyl. On 13-FEB-2007, the patient recovered. Additional information has been requested. 06/01/2007 Information has been received from a physician and healthcare professional concerning a 6-month-old healthy female with an allergy to milk protein and no other medical history who on 16-JAN-2007 was vaccinated PO with the first dose of ROTATEQ (Lot #655175/0849F). There was no concomitant therapy or illness at the time of vaccination. On 07-FEB-2007, the patient developed diarrhea. No fever was noted. On 09-FEB-2007, the patient was seen in the physician's office. A stool test was negative for rotavirus and positive for Giardia. The patient was treated with FLAGYL. On 27-FEB-2007 (previously reported as 13-FEB-2007), the patient recovered. The physician did not feel the Giardia was related to ROTATEQ. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with the first dose of Rotateq and did not return on time for the second dose. The physician reported, that the patient developed chickenpox (unknown if medical attention was sought) since the first dose and was in the office awaiting vaccination with the second dose (unknown if 2nd dose was given). At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 11-week-old female with no medical history who on 08-FEB-2007 was vaccinated PO with the first 2.0 mL dose of Rotateq. The physician reported that on 20-FEB-2007, the patient developed vomiting and diarrhea. Unspecified medical attention was sought and the patient was hospitalized for one night. No laboratory/diagnostic tests were performed. In February 2007, the patient's diarrhea and vomiting resolved. Additional information has been requested.
Age: 0.45
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a nurse practitioner (NP) concerning a 2 month old male who was vaccinated PO, at 2 months old, with the first 2.0 mL dose of Rotateq. The NP reported that in 2007, the patient developed diarrhea for 10 days. The patient was seen in the Emergency Room (ER), but was not hospitalized. The patient's formula was changed and the patient subsequently recovered. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 3/14/2007.  Information has been received from a nurse practitioner (NP) concerning a 23-week-old (previously reported as 2-month-old) black male with eczema and hypospadias who was vaccinated PO, at 2 months old, with the first 2.0 mL dose of ROTATEQ and on 12-JAN-2007 with the second PO dose of ROTATEQ (Lot #654392/0578F).  The NP reported that on 15-JAN-2007, the patient developed diarrhea and vomiting.  The patient was seen in the Emergency Room (ER), but was not hospitalized.  It was noted that the patient had up to 10 watery stools per day.  The patient's formula was changed and the patient recovered on 21-JAN-2007.  Additional information is not expected.
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning her "under 1-year-old" daughter who was vaccinated PO with the second dose of Rotateq (lot number not provided). The physician reported that, within 24 hours of being vaccinated, her daughter developed diarrhea. Unspecified medical attention was sought. The patient was considered to be recovered as she was noted to be doing fine. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a registered nurse concerning a 6-month-old patient who was vaccinated with the first dose of Rotateq. It was unknown if medical attention was sought. No symptoms were reported. Additional information has been requested
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a second dose of Rotateq. Subsequently the patient developed increased loose stool and watery diarrhea. It was not reported it medical attention was sought. This event was not considered to be life threatening, no special treatment was required or dehydration in the patient. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a health professional concerning a 17-week-old male who was vaccinated with a first dose of Rotateq. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received fro a physician concerning 15 children who were vaccinated PO with the first 2.0 ml dose of Rotateq after 32 weeks of age. Medical attention was not sought. It was noted that the children only received the first dose in the series. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Gastroenteritis, Rotavirus test positive
Clinical narrative: Information has been received from a health professional concerning an 18 week old female who on 02-JAN-2007 was vaccinated with an oral dose of Rotateq (lot # 654422/0607F). There was no concomitant medication . Subsequently the patient developed gastroenteritis. On 25-FEB-2007 the patient had a positive rotavirus test. Unspecified medical attention was sought. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a nurse practitioner concerning four patients who were vaccinated with a second dose of Rotateq. It was reported that the patients were late for their second dose. All four patients presented to the office later than 10 weeks post dose 1. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
Age: 0.44
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning an 8 month old male with oesophageal reflux and no drug reactions/allergies who vaccinated with a first and second oral dose with a 2mL of Rotateq on 18-SEP2006 (lot # 654248/0577F) and 30-NOV-2006 (lot # 654489/0941F). There was no concomitant medication. Illness at the time of vaccination included viral gastroenteritis. On 26-FEB-2007 the patient developed diarrhea. The infant had diarrhea in which there were 9-10 stools a day. The patient vomited "last night" after eating. The nurse mentioned that in general the infant spits up eating after eating. On 28-FEB-2007, the infant had one diarrhea episode and one vomiting episode. Unspecified medical attention was sought. No labs were performed. The nurse felt that the physician giving the infant ZANTAC for reflux and Culturelle for the diarrhea was intervention. At the time of the report the patient was recovering. The third dose was not given. There  was no product quality complaint involved. Vomited and diarrhea were considered to be other important medical events. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Infantile spitting up, Underdose
Clinical narrative: Information has been received from a nurse concerning a 2-month-old patient who on 11-SEP-2006 was vaccinated PO with the first dose of Rotateq. The nurse reported that on 11-SEP-2006, the patient spit up some of the vaccine. It was unknown if medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning an 8-week-old female birth twin who on 12-FEB-2007, at 1430, was vaccinated PO with the first 2.0 ml dose of Rotateq (Lot #656105/1232F). Concomitant vaccinations administered on that same day and time included the first IM dose in the left thigh of Pediarix (Lot #AC21B092AA) and the first IM dose in the right thigh of ActHib (Lot #UE704AA) and the first IM dose in the right thigh of Prevnar (Lot #B08672K). The physician reported that on 12-FEB-2007, at 1630, the patient developed acute diarrhea. Unspecified medical attention was sought, but no laboratory/diagnostic test were performed. The patient's acute diarrhea subsequently resolved. The physician also reported that the patient's twin brother also developed acute diarrhea after receiving the first dose of Rotateq (Lot #656105/1232F) (WAES #0702USA03796). No further information is available.
Age: 0.22
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 11 week old male with no medical history or allergies who was vaccinated with a 2 ml oral first, second and third dose of Rotateq on 24-OCT-2007, 07-NOV-2006 and 09-JAN-2007. There was no concomitant medications. There was no problems reported with administration. Unspecified medical attention was sought. No laboratory test were performed. There was no product quality complaint involved. Additional information is not expected.
Age: 0.38
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a registered nurse concerning a 17 week old infant who was vaccinated on 14-SEP-2006 with an oral dose of Rotateq. No problems were reported. It was not reported if medical attention was sought. There was no product quality complaint involved. Additional information has been requested
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a registered nurse concerning a 24 week old infant who was vaccinated on 26 Sep 2006 with and oral dose of Rotateq. No problems were reported. It was not reported if medical attention was sought. There was no product quality complaint involved. Additional information is not expected
Age: 0.48
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a registered nurse concerning a 19 week old infant who was vaccinated on 26-SEP-2007 with an oral dose of Rotateq. No problems were reported. It was not reported if medical attention was sought. There was no product quality complaint was involved. Additional information is not expected.
Age: 0.45
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a registered nurse concerning a 22 week old infant who was vaccinated on 28-SEP-2007 with an oral dose of Rotateq. No problems were reported. It was not reported if medical attention was sought. There was no product quality complaint was involved. Additional information is not expected.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a registered nurse concerning a 25 week old infant who was vaccinated on 10-OCT-2007 with an oral dose of Rotateq. No problems were reported. It was not reported if medical attention was sought. There was no product quality complaint was involved. Additional information is not expected.
Age: 0.37
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a registered nurse concerning a 19 week old infant who was vaccinated on 10-Oct-2006 with an oral dose of Rotateq. No problems were reported. It was not reported if medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
Age: 0.32
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a registered nurse concerning a 16 week old infant who was vaccinated on 12-Oct-2006 with and oral dose of Rotateq. No problems were reported. It was not reported if medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
Age: 0.35
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a registered nurse concerning a 17 week old infant who was vaccinated on 26-OCT-2007 with an oral dose of Rotateq. No problems were reported. It was not reported if medical attention was sought. There was no product quality complaint was involved. Additional information is not expected.
Age: 0.32
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a registered nurse concerning a 19 week old infant who was vaccinated on 13 Oct 2006 with an oral dose of Rotateq. No problems were reported, it was not reported if medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
Age: 0.42
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a registered nurse concerning a 20 week old infant who was vaccinated on 13-Nov-2006 with an oral dose of Rotateq (human bovine). No problems were reported. It was not reported if medical attention was sought.  There was no product quality complaint involved. Additional information is not expected.
Age: 0.38
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a registered nurse concerning a 18 week old infant who was vaccinated on 13-Nov-2006 with an oral dose of Rotateq. No problems were reported. It was not reported if medical attention was sought. There was no product quality complaint involved. Additional information in not expected.
Age: 0.59
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a  registered nurse concerning a 30 week old infant who was vaccinated 20-NOV-2006 with an oral dose of Rotateq. No problems were reported. It was not reported if medical attention was sought. There was no product quality involved. Additional information is not expected.
Age: 0.36
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a registered nurse concerning a 18 week old infant who was vaccinated 21-NOV-2006 with an oral dose of Rotateq. No problems were reported. It was not reported if medical attention was sought, There was no product quality complaint involved. Additional information is not expected.
Age: 0.53
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a registered nurse concerning a 27 week old infant who was vaccinated on 27-NOV-2007 with an oral dose of Rotateq. No problems were requested. It was not reported if medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
Age: 0.38
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a registered nurse concerning a 17 week old infant who was vaccinated on 30-NOV-2006 with an oral dose of Rotateq. No problems were reported. It was not reported if medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
Age: 0.34
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a registered nurse concerning a 18 week old infant who was vaccinated on 30-NOV-2006 with an oral dose of Rotateq. No problems were reported. It was not reported if medical attention was sought. There was no product complaint involved. Additional information is not expected.
Age: 0.41
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a registered nurse concerning a 20 week old infant who was vaccinated on 04-DEC-2005 with an oral dose of Rotateq. No problems were reported. It was not reported if medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
Age: 0.53
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a registered nurse concerning a 27 week old infant who was vaccinated on 05-DEC-2006 with an oral dose of Rotateq. No problems were reported. It was reported if medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
Age: 0.34
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a registered nurse concerning a 17 week old infant who was vaccinated on 05-DEC-2006 with an oral dose of Rotateq. No problems were reported. It was not reported if medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
Age: 0.52
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a registered nurse concerning a 20 week old infant who was vaccinated on 07-DEC-2007 with an oral dose of Rotateq. No problems were reported. It was not reported if medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
Age: 0.34
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a registered nurse concerning a 16 week old infant who was vaccinated on 14-DEC-2006 with an oral dose of Rotateq. No problem were reported. It was reported if medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
Age: 0.42
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a registered nurse concerning a 21 week old infant who was vaccinated on 19-DEC-2006 with an oral dose of Rotateq. No problems were reported. It was not reported if medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
Age: 0.25
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a registered nurse concerning a 13 week old infant who was vaccinated on 19-DEC-2006 with an oral dose of Rotateq. No problems were reported. It was reported if medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
Age: 0.45
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a registered nurse concerning a 23 week old infant who was vaccinated on 19-DEC-2006 with an oral dose of Rotateq. No problems were reported. It was not reported if medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
Age: 0.37
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a registered nurse concerning a 19 week old infant who was vaccinated on 19-DEC-2006 with an oral dose of Rotavirus. No problems were reported. It was not reported if medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
Age: 0.39
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a registered nurse concerning a 19 week old infant who was vaccinated on 27-DEC-2006 with an oral dose of Rotateq. No problems were reported. It was not reported if medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
Age: 0.54
Sex: U
Vaccine: RV5
Symptoms: Drug ineffective, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a 29 week old infant who was vaccinated on 28-DEC-2006 with an oral dose of Rotateq. No problems were reported. It was not reported if medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
Age: 0.26
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a registered nurse concerning a 13 week old infant who was vaccinated on 02-JAN-2007 with an oral dose of Rotateq. No problems were reported. It was not reported if medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, HPV4, FLU3, HPV4
Symptoms: Electroencephalogram, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a physician concerning an adolescent female (demographics not provided) who on an unspecified date was vaccinated with the first dose of Gardasil (lot # not provided). Concomitant therapy included an unspecified anti malaria medication. Subsequently, on an unspecified date " a few days later" the patient had a seizure. It was reported by the physician that at the time "the patient has a series of tests (NOS) but no diagnosis was found. On another unspecified date the patient received the second dose of Gardasil (lot # not provided) and sixteen days post vaccination, on an unspecified date the patient had seizure. The patient sought unspecified medical attention. The physician reported that it was not known if additional test were completed. The physician reported that the patient had recovered from the seizures. Upon internal medical review, the seizures were felt to be other medical events. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, HPV4, FLU3, HPV4
Symptoms: Convulsion, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning an adolescent female (demographics not provided) who on an unspecified date was vaccinated with the first dose of Gardasil (lot # not provided). Concomitant therapy included an unspecified anti malaria medication. Subsequently, on an unspecified date " a few days later" the patient had a seizure. It was reported by the physician that at the time "the patient has a series of tests (NOS) but no diagnosis was found. On another unspecified date the patient received the second dose of Gardasil (lot # not provided) and sixteen days post vaccination, on an unspecified date the patient had seizure. The patient sought unspecified medical attention. The physician reported that it was not known if additional test were completed. The physician reported that the patient had recovered from the seizures. Upon internal medical review, the seizures were felt to be other medical events. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, HPV4, FLU3, HPV4
Symptoms: Convulsion, Electroencephalogram normal, Gaze palsy, Laboratory test, Loss of consciousness
Clinical narrative: Information has been received from a physician concerning an adolescent female (demographics not provided) who on an unspecified date was vaccinated with the first dose of Gardasil (lot # not provided). Concomitant therapy included an unspecified anti malaria medication. Subsequently, on an unspecified date " a few days later" the patient had a seizure. It was reported by the physician that at the time "the patient has a series of tests (NOS) but no diagnosis was found. On another unspecified date the patient received the second dose of Gardasil (lot # not provided) and sixteen days post vaccination, on an unspecified date the patient had seizure. The patient sought unspecified medical attention. The physician reported that it was not known if additional test were completed. The physician reported that the patient had recovered from the seizures. Upon internal medical review, the seizures were felt to be other medical events. Additional information has been requested.