chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Choking, Dyspnoea, Foreign body aspiration
Clinical narrative: Information has been received from a nurse practitioner concerning a 9 week old female with no allergies and a history of easily choke who on 03-JUN-2011 was vaccinated with a dose of ROTATEQ (lot # 669071/1269Z, expiration date 15-AUG-2012). Concomitant therapy included PENTACEL and PREVNAR at the same office visit. On 03-JUN-2011 the patient choked and might have aspirated a dose of ROTATEQ and had trouble catching her breath during administration. The patient was kept of the office for 1 hour after the choking incident and then went home recovered. The patient did not require any treatment for the choking incident. Additional information has been requested.
Age: 0.19
Sex: F
Vaccine: RV5
Symptoms: Oral administration complication, Vomiting
Clinical narrative: Information has been received from a health care worker concerning a 9 week old female patient who on an unspecified date was vaccinated with a dose of ROTATEQ (dose and lot # not reported). The health care worker reported that on an unspecified date, the patient regurgitated almost immediately after receiving a dose of ROTATEQ. No treatment for the adverse event was given. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. Follow up information has been received from the health professional concerning a 8 week old female patient who on 12-JUL-2011 at 14:24 was vaccinated at a private doctor's office with the first dose of ROTATEQ (dose not reported) and lot # 668953/1137Z. The healthcare reported that on 12-JUL-2011 at 14:24 the patient vomited right after dose of ROTATEQ was given. At the time of the report, the patient's outcome was unknown. No further information is available.
Age: 0.62
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a 7 month old (also reported as 32 weeks and 2 days) patient who was vaccinated with the first and second dose of ROTATEQ (Lot numbers not reported, on 07-DEC-2010 and 15-FEB-2010 respectively and today, on 24-MAY-2011 was in the office to receive the third dose. No adverse effects were reported. Follow-up information has been received from a certified medical assistant who reported that 7 month male patient with no illness at time of vaccination or pre-existing allergies, birth defects, medical conditions and no adverse events following prior vaccination was vaccinated orally with third dose of ROTATEQ (Lot number 669829/0076AA) on 24-MAY-2011 at 01:14 pm. There were no laboratory diagnostic tests performed. The patient did not seek medical attention. No further information is available.
Sex: F
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Oral administration complication
Clinical narrative: Information has been received from a Nurse Practitioner (N.P.) concerning an approximately 28 day old (reported as a 4 week old) female patient who on 14-FEB-2011 was vaccinated orally with the first dose of ROTATEQ (lot # not reported). The nurse practitioner stated that this infant spat out an unknown amount of this dose. No adverse effect reported. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. This is an amended report. The reporting status was changed from do not send to periodic.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a physician concerning an approximately 9 week old patient with a history of pyelonephritis at 1 month of age and was on 4 days of IV antibiotics and then followed by 12 days of SUPRAX therapy and no drug allergy who on 19-APR-2011 was vaccinated with the first dose of ROTATEQ (dose, route and lot# not reported). On 20-APR-2011 the patient developed diarrhea and vomiting on 21-APR-2011. It was unspecified if the patient sought medical attention. The child was treated with unspecified over the counter medication. Family of child has not called back to the office so it was believed that child was recovering. Additional information has been requested.
Age: 0.54
Sex: M
Vaccine: RV5
Symptoms: Cough, Oral administration complication, Vomiting
Clinical narrative: Information has been received from a licensed practitioner nurse concerning a 6 month old male patient who was vaccinated orally with the first, second and third dose of ROTATEQ on 27-OCT-2010, 24-JAN-2011 and 07-MAR-2011 respectively (lot # 668271/0514Z, expiration: 16-APR-2012). The nurse reported that on 07-MAR-2011 the patient was given this third dose of ROTATEQ. About 10 minutes after the child received the vaccine, he began to cough and then regurgitated the vaccine. The child had had no previous problems when he received the first two doses. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. Follow up information has been received form the licensed practical nurse who reported that on an unspecified date, the approximately 6 month old patient with no illness at the time of vaccination, no known drug allergies was vomiting right after ROTATEQ was given. Secondary suspect therapy included hepatitis B virus vaccine rHBsAg (lot # 666600/0319Z) given on 24-JAN-2011 intramuscularly in the left arm. The patient did not seek medical attention. No lab diagnostics studies were performed. At the time of reporting, the patient had recovered from voting. No further information is available.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a consumer concerning her 15 weeks old son, who on an unspecified date was vaccinated with the first dose of ROTATEQ, 2 ml, oral (lot number not reported). The reporter stated "my son didn't get his first ROTATEQ vaccine until he was 15 weeks old. I see he should have gotten it by 12 weeks old". No further information is available.
Sex: F
Vaccine: RV5
Symptoms: Accidental exposure, Eye irrigation, Eye irritation, Eye pain
Clinical narrative: Information has been received from a registered nurse concerning a patient care assistant who on an unspecified date got some of the ROTATEQ (lot number 668953/1137Z, expiry date 05-AUG-2012) in her eye during administration of vaccine to a patient. She was currently experiencing mild discomfort and burning. The patient care assistant was treated with flushing eye with water. She did not seek medical attention. At the time of report the patient care assistant's status was not recovered. Additional information has been requested. This is one of several reports from the same source.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning an approximately 9 month old (reported as "35-36 weeks of age") patient who on 29-JUN-2011 was administered a third dose of ROTATEQ (Lot # not reported). The nurse did not know the dates of when the first two doses of ROTATEQ were given. No adverse event was reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Oral administration complication, Vomiting
Clinical narrative: Information has been received from a physician concerning a female baby who "this week", on approximately 27-JUN-2011, was vaccinated orally with the third dose of ROTATEQ (Lot number not provided). It was reported that "other vaccines might have been administered". "This week", on approximately 27-JUN-2011, the patient threw up after receiving ROTATEQ. The patient vomited in the waiting room immediately following administration and vomited again the same day after returning home. No lab diagnostics studies performed. The patient sought unspecified medical attention. She was on therapy and the event improved. On an unspecified date, the patient recovered. Additional information has been requested.
Age: 0.43
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a 20 week old patient who on 21-JUL-2011 was given a first dose of ROTATEQ (2ml, orally, Lot# 668359/0982Z). The patient was not experiencing any known symptoms. It was unknown if the patient had sought any medical attention. No further information is available.
Age: 0.6
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Urticaria
Clinical narrative: This report was received from Pfizer inc. and was assigned manufacturer report number 2011131829 for PREVNAR. Information has been received from a medical assistant concerning a 28 weeks female patient who on 01-APR-2011 was vaccinated with the first dose of ROTATEQ. On the same day the patient received the first dose of hepatitis B vaccine, recomb (manufacturer unspecified), the first dose of PREVNAR and the first dose of PENTACEL. There was no concomitant medication. On 01-APR-2011 the patient experienced hives following administration with the vaccines. At the time of the report the patient was recovering. This was originally reported by a medical assistant. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a consumer concerning his 8 weeks old daughter who on 02-AUG-2011, was vaccinated with the first dose of ROTATEQ (dose and lot number not reported). "After receiving her first dose on 02-AUG-2011, the consumer stated that his daughter vomited. The patient did not seek medical attention. At the time of the report the outcome of the patient was unknown. No further information is available.
Age: 0.8
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning an older than 8 month old patient who on an unspecified date was vaccinated with the third dose of ROTATEQ (lot# not reported). The patient was not experiencing any known symptoms. Additional information has been requested.
Age: 0.8
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a health care worker concerning a 9 month old patient who on an unspecified date was vaccinated orally with the second dose of ROTATEQ (dose and lot# not reported). No adverse symptoms noted. Additional information has been requested.
Age: 0.16
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Occult blood negative, Parasite stool test negative, Pyrexia, Rotavirus test negative
Clinical narrative: Information has been received from a physician concerning a 57 day old male patient who on 20-APR-2011, was vaccinated with the first dose of ROTATEQ (lot number: 669827/0257AA, expiration date: 28-OCT-2012), 2 ml, orally. On 20-APR-2011, after receiving ROTATEQ, the patient experienced "loose stools for 1 month". The patient was seen by a gastroenterologist. Therapy with ROTATEQ was discontinued. At the time of the report, the patient recovered from loose stools (on 20-MAY-2011). Follow up information has been received from the physician concerning the 59 day old male patient with no illness at time of vaccination, who on 20-APR-2011 experienced non bloody diarrhea (4-8 per day) and fever (100 degrees max) for 10 days. On 05-May-2011 hemoccult test, stool O and P (stool ova and parasites) test and rotavirus antigen by enzyme immunoassay (x2) were performed which showed a negative results. It was reported that the patient recovered by 19-MAY-2011. No further information is available.
Age: 0.36
Sex: F
Vaccine: RV5
Symptoms: Urticaria
Clinical narrative: Information has been received from a registered nurse concerning an 18 weeks old female patient who on 14-JUN-2011 was vaccinated with a dose of ROTATEQ (Lot Number 0059AA is an invalid lot number for ROTATEQ; expiration date unknown). On 14-JUN-2011 the patient received ROTATEQ and developed hives upon the face immediately. The patient did not seek medical attention. The symptoms resolved without treatment within 15 minutes. Follow-up information was received from a registered nurse who stated that the 18 weeks old female patient with no illness at time of vaccination and no pre-existing allergies, birth defects and no medical conditions, was vaccinated with PO with the second dose of ROTATEQ (lot # 669832/0259AA) at 9:45 am. It was reported that within 5 minutes of receiving the second dose of ROTATEQ, the patient developed hives on body. There were no signs of respiratory diseases or facial swelling. There was no diagnostic test performed. The symptoms resolved spontaneously after 15 minutes. Additional information is not expected.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Feeling hot, Induration, Mobility decreased, Pain, Ultrasound scan
Clinical narrative: Ct called 4/9/12 c/o increase pain. Ct in c/o pain 6 1-10 pain scale. Increase warmth & induration. Referred to urgent care. In f/u seen urgent care ultrasound done, antibiotics prescribed recommend to take ADVIL. 4/10/12 09:30 voice message left & call returned at 10:00 reports he is feeling much better & can raise arm today.
Age: 0.41
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a 19 weeks old patient who on 24-FEB-2011 was orally vaccinated with the first dose of ROTATEQ (Lot# and expiration not reported). The physician reported that inadvertently the patient was given ROTATEQ by mouth by the patient was over 15 weeks old. Physician reported that the patient was born on 26-SEP-2010 and the patient received the first dose of ROTATEQ on 24-FEB-2011. No adverse effects reported. At the time of reporting the patient's outcome was unknown. Additional information has been requested.
Age: 0.37
Sex: M
Vaccine: RV1
Symptoms: Diarrhoea, Pyrexia, Rotavirus infection, Rotavirus test positive, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a 22 month old male with no medical history and no drug reactions/allergies who on 26-MAY-2009 was vaccinated with the first dose of ROTATEQ (lot # 663842/0068Y, oral). The reporter stated that on 24-FEB-2011 the patient developed diarrhea and rotavirus infection after receiving ROTATEQ and ROTARIX. The patient received the ROTATEQ on 26-MAY-2009 and ROTARIX on 27-AUG-2009. The patient did not get the third dose. No treatment was given for the event. Rotavirus test was performed showed positive. At the time of reporting, the patient was recovering from diarrhea and rotavirus infection. The patient sought unspecified medical attention. Follow-up information was concerning a 22 month male who on 26-MAY-2009 was vaccinated with the first dose of ROTATEQ (lot # 663842/0068Y, oral). Secondary suspect therapy included a dose of ROTARIX (lot #: A41FA850A) on 27-AUG-2009. The reporter stated that on 23-FEB-2011 the patient developed diarrhea, fever and vomiting, the patient was seen in office on 24-FEB-2011. On 24-FEB-2011, Rotavirus stool screen was performed showed positive. At the time of reporting, the patient had recovered. Follow up information was concerning the male patient who on 24-FEB-2011 (previously reported as 23-FEB-2011) came to the office with diarrhea, temperature (previously reported as fever) and vomiting. At the time of the report, the patient had recovered. No further information is available.
Age: 0.17
Sex: F
Vaccine: HEP, PNC, RV5
Symptoms: Immediate post-injection reaction, Vomiting
Clinical narrative: Information has been received from a nurse concerning an 8 week old female who on approximately 29-JUN-2010 was vaccinated orally with the first stand dose of ROTATEQ. Secondary suspect therapy included hepatitis B virus vaccine (unspecified) (manufacturer unknown). Other concomitant therapy included PREVNAR and PENTACEL. On approximately 29-JUN-2010 ("immediately following the administration"), the patient had vomiting. No treatment was given for vomiting. At the time of the report, the patient had recovered from vomiting ("alive and well"). The patient did not seek medical attention. Follow up information has been received from a License Practitioner Nurse (L.P.N.) reported that the female with no known drug allergy who at 15:10 on 30-JUN-2011 was vaccinated orally with the second dose of ROTATEQ (lot#0308z is an inbalida lot number for ROTATEQ), secondary suspect on the same date included the second dose of hepatitis B virus vaccine rHBsAg (lot#666183/1481Y) IM in her right arm, Concomitant therapy on the same date included the second dose of PREVNAR (lot#E77469) IM in her right arm. At 15:10 on 30-JUN-2010, the patient vomited immediately after giving vaccination. On the same date, the patient recovered from vomiting. The patient did not seek medical attention. No further information is available.
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a medical assistant's child (female) who on 01-FEB-2011 was vaccinated orally with ROTATEQ (Lot #668038/0596z). On 07-FEB-2011 (six days later, and reported as 01-FEB-2011), the patient experienced diarrhea. The patient sought unspecified medical attention. The treatment of hydration and soy formula was given for diarrhea. At the time of this report, the patient was recovering. Additional information has been requested.
Age: 0.51
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Rotavirus infection, Rotavirus test positive, Stool analysis abnormal
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 6 month old patient who on 18-JUL-2008 was vaccinated with the first dose of ROTATEQ (lot # 660377/0274X), the second dose on 19-SEP-2008 (lot # 661031/0476X) and the third dose on 18-NOV-2008 (lot # 662603/1271X, dose and route not reported). On 23-FEB-2011 the patient presented with rotavirus and the lab confirmed presence of rotavirus in the child's stool. The child had diarrhea for five days, multiple daily episodes. The patient was not hospitalized and had "now" (approximately in February 2011) recovered. Follow up information was received from a registered nurse (R.N.) and medical records a thirty three month old male (14.6kg, 38") who was vaccinated with oral ROTATEQ, the first dose given on 18-JUL-2008, the second dose on 19-SEP-2008 and the third dose on 18-NOV-2008. The nurse reported that the patient had all three doses of ROTATEQ at appropriate age and intervals. On 18-FEB-2011 the patient experienced diarrhea (duration unknown). Stool specimen was collected on 23-FEB-2011 and on 24-FEB-2011 results for rotavirus EIA value was reported positive. At the time of the report the patient recovered. This is an amended report. Adverse event of inappropriate schedule of drug administered was removed and patient's age of thirty three months was updated to patient demographic screen. All available medical records will be provided upon request. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a consumer concerning his daughter who on an unspecified date was vaccinated with a dose of ROTATEQ (lot # not reported). Subsequently the patient vomited. The outcome of vomiting was unknown. It was unknown if the patient seek medical attention. No further information is available.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, HEP, RV5
Symptoms: Bacterial test negative, Body temperature increased, Clostridium test negative, Culture stool negative, Diarrhoea
Clinical narrative: Information has been received from a Nurse Practitioner concerning an approximately 12 month old male patient who was vaccinated orally with the first, second and third dose of ROTATEQ on 01-APR-2010 (Lot #664883/1523Y), 02-JUN-2010 (Lot #665259/0202Z) and 02-AUG-2010 (Lot#667461/0500Z) respectively. The nurse reported that "a few weeks ago" (approximately on 17-JAN-2011), the patient had a moderate case of diarrhea with no vomiting, which on 17-JAN-2011 tested positive for Rotavirus. At the time of the report patient's outcome was not reported. Patient sought unspecified medical attention. Follow up information has been received from medical records and a physician concerning a 7 month old female patient (initially reported as 12 month old male) with no previous pre-existing allergies, birth defects or medical conditions who on 02-AUG-2010 was vaccinated with her third dose of ROTATEQ (Lot # 664883/1523Y, conflicting information initially reported as Lot # 667461/0500Z). Concomitant medications were RECOMBIVAX HB (Lot # 1482Y) administered intramuscular left site (02-AUG-2010) and had (two previous doses) and PENTACEL (Lot # C3513B4) administered intramuscular left site (02-AUG-2010) and had (two previous doses). On 17-JAN-2011, the patient was evaluated in the emergency room for diarrhea (six to seven watery stools a day without blood or vomiting noted). The patient had a increased temperature of a hundred and one for twenty four hours. On 18-JAN-2011, the patient had the following stool diagnostic tests performed: negative for Fecal leukocytes; negative for Fecal occult blood; Aerobic culture negative for Salmonella, Campylobacter, Shiga toxin 1 and 2, and Giardia and Cryptosporidium; negative for Clostridium difficile Toxin A/B; and positive for rotavirus. The patient's caregiver was noted as having similar symptoms a week prior to the patient's own symptoms. On "02-JUN-2011", the patient's previous immunization (conflicting information as initially noted the patient's second dose of vaccine was administered on 02-JUN-2010), it was noted that she had two days of nasal congestion. The patient had no other illnesses to any of her well clinic visits. The patient recovered from her symptoms on 31-JAN-2011. All telephone attempts to obtain follow-up information have been unsuccessful. All available medical records will be provided upon request. Additional information has been requested.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, HEP, RV5
Symptoms: Nasal congestion, Occult blood negative, Rotavirus test positive, White blood cells stool negative
Clinical narrative: Information has been received from a Nurse Practitioner concerning an approximately 12 month old male patient who was vaccinated orally with the first, second and third dose of ROTATEQ on 01-APR-2010 (Lot #664883/1523Y), 02-JUN-2010 (Lot #665259/0202Z) and 02-AUG-2010 (Lot#667461/0500Z) respectively. The nurse reported that "a few weeks ago" (approximately on 17-JAN-2011), the patient had a moderate case of diarrhea with no vomiting, which on 17-JAN-2011 tested positive for Rotavirus. At the time of the report patient's outcome was not reported. Patient sought unspecified medical attention. Follow up information has been received from medical records and a physician concerning a 7 month old female patient (initially reported as 12 month old male) with no previous pre-existing allergies, birth defects or medical conditions who on 02-AUG-2010 was vaccinated with her third dose of ROTATEQ (Lot # 664883/1523Y, conflicting information initially reported as Lot # 667461/0500Z). Concomitant medications were RECOMBIVAX HB (Lot # 1482Y) administered intramuscular left site (02-AUG-2010) and had (two previous doses) and PENTACEL (Lot # C3513B4) administered intramuscular left site (02-AUG-2010) and had (two previous doses). On 17-JAN-2011, the patient was evaluated in the emergency room for diarrhea (six to seven watery stools a day without blood or vomiting noted). The patient had a increased temperature of a hundred and one for twenty four hours. On 18-JAN-2011, the patient had the following stool diagnostic tests performed: negative for Fecal leukocytes; negative for Fecal occult blood; Aerobic culture negative for Salmonella, Campylobacter, Shiga toxin 1 and 2, and Giardia and Cryptosporidium; negative for Clostridium difficile Toxin A/B; and positive for rotavirus. The patient's caregiver was noted as having similar symptoms a week prior to the patient's own symptoms. On "02-JUN-2011", the patient's previous immunization (conflicting information as initially noted the patient's second dose of vaccine was administered on 02-JUN-2010), it was noted that she had two days of nasal congestion. The patient had no other illnesses to any of her well clinic visits. The patient recovered from her symptoms on 31-JAN-2011. All telephone attempts to obtain follow-up information have been unsuccessful. All available medical records will be provided upon request. 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 a 5 months and 9 days old patient who on 15-FEB-2011 was vaccinated with the first dose of ROTATEQ (lot# not reported). No adverse effect reported. Additional information has been requested.
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, HEP, RV5
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a 19 weeks boy with a history of born premature and no drug reactions or allergies who on 26-APR-2011 was vaccinated orally with a dose of (Lot # 668908/1135z). Secondary suspect therapy included a dose of hepatitis B virus vaccine rHBsAg (dose, route and Lot # not reported). Concomitant therapy included PENTACEL, PREVNAR and iron (unspecified) (+) vitamins (unspecified). On 26-APR-2011 the patient had a low-grade fever later in the evening. The patient's parent spoke to physician on phone to seek medical attention. The patient was treated with TYLENOL. No lab diagnostic studies were performed. At the time of the report, the patient was recovering. This is one of several reports concerning the sibling. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacy technician concerning unspecified number of patients (pediatric and/or adolescent) who in March 2011, were vaccinated with ROTATEQ (lot # not reported), which were exposed to very low temperature within a more than 2 months (also reported as 3 months) period from 05-JAN-2011 to 18-MAR-2011. No adverse events reported. This is one of several reports from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated orally with the second dose of 2ml ROTATEQ (lot # not reported). After being given the vaccination ("a couple months ago") the patient experienced vomiting about twice a day for a week but did not have diarrhea. The patient had sought unspecified medical attention and was given PEDIALYTE solution for treatment of the adverse event. At the time of reporting, the adverse event improved but the patient's outcome was unknown. There was no adverse event after the first dose. No further information is available.
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a 19 weeks boy with a history or born premature and no drug reactions or allergies who on 26-APR-2011 was vaccinated orally with a dose of ROTATEQ (lot # 668908/1135Z). Secondary suspect therapy included a dose of RECOMBIVAX HB (dose, route and lot # not reported). Concomitant therapy included PENTACEL, PREVNAR, PREVACID and iron (unspecified) & vitamins (unspecified). On 26-APR-2011 the patient had a low-grade fever in the evening. The patient's parent spoke to physician on phone to seek medical attention. The patient was treated with TYLENOL. No lab diagnostics studies were performed. At the time of the report, the patient was recovering. Follow-up information was received from the physician indicating that the 19 weeks boy with a history of Ex-preterm (27 weeks/745gm) who on 26-APR-2011 at 1:45 PM was vaccinated orally with the first dose of ROTATEQ (Lot # 668908/1135Z) at private doctor's office/hospital. At the time of the report, there was on adverse event reported. This is one of several reports concerning the sibling. No further information is available.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Pyrexia, Rotavirus infection, Rotavirus test positive
Clinical narrative: Information has been received from a registered nurse concerning a 17 weeks male patient, with no pertinent medical history and no known drug allergies who on 29-DEC-2010, was vaccinated with the first dose of ROTATEQ, oral administration (Lot number 668361/1062Z and expiration date: 07-May-2012). There was no concomitant medication. The registered nurse reported that on approximately 25-FEB-2010 ("1 week ago") the patient developed severe diarrhea and fever after administration of the first dose of ROTATEQ. The patient was diagnosed with rotavirus. On 01-MAR-2011 there was a stool sample performed with -positive for rotavirus as result. The patient sought unspecified medical attention. The patient received hydration as treatment. At the time of reporting the patient was recovering. Additional information has been requested.
Sex: U
Vaccine: RV1, RV5
Symptoms: Drug name confusion, No adverse event
Clinical narrative: Information has been received from a nurse concerning a patient who on an unspecified date was vaccinated with a dose of ROTATEQ (Lot #, expire date and route not reported). Suspect therapy included ROTARIX. Nurse stated that she was confused by an immunization report and confused ROTATEQ with ROTARIX and thought ROTATEQ was only a two dose series. No adverse effect was reported. Additional information has been requested.
Age: 0.38
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 20 weeks old female who on 15-MAR-2011, was vaccinated with the first dose of ROTATEQ, oral (lot number not reported). No adverse effects were reported. Additional information has been requested.
Age: 0.39
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a Registered Nurse concerning a 20 week old patient who on 15-OCT-2010, was vaccinated with the first dose of ROTATEQ (route, dose and lot# not provided). The patient sought unspecified medical attention. Additional information has been requested.
Age: 0.56
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a certified medical assistant concerning a 6 month old patient who on 22-SEP-2010 was vaccinated with a first dose of ROTATEQ (Lot# not reported), PO and on 08-FEB-2011 was vaccinated with a second dose of ROTATEQ (Lot# not reported), PO. No adverse effect. Follow up information has been received from a certified medical assistant. It was reported that on 08-FEB-2011 the female patient was vaccinated with a second oral dose of ROTATEQ (Lot number 668358/0917Z). Concomitant vaccinations given the same day included a second dose of PEDIARIX (lot number AC21B256AA) given IM, a second dose of ACTHIB (lot number UH239AB) given IM and a second dose of PREVNAR (lot number 914514) given IM. No further information is expected.
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse concerning an approximately 16 weeks old patient who on 18-JAN-2011, 01-FEB-2011 and 24-MAR-2011 was vaccinated PO with the first, second and third dose of ROTATEQ (lot # and expiration date: the first dose 668359/0987Z, 06-MAY-2012; the second dose 668967/1201Z, 12-AUG-2012; the third dose 668824/2528Z, 08-JUL-2012), respectively. No adverse effect was reported. Additional information has been requested.
Age: 0.38
Sex: F
Vaccine: RV1
Symptoms: Abnormal faeces, Diarrhoea, Faeces discoloured, Pyrexia, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning a 23 month old female with no pertinent medical history or drug reactions/allergies who on 21-MAY-2009 was vaccinated with ROTATEQ (lot # 663846/0067Y, expiration date 12-APR-2009). Concomitant therapy PENTACEL and PREVNAR. The patient was vaccinated with ROTARIX on 09-JUL-2009. On 08-FEB-2011 the patient experienced vomiting, diarrhea (that was yellow and foul smelling) and fever of 101 F. No treatment was given. This patient had been exposed for an entire week to another patient that had rotavirus (WAES # 1102USA00878). The patient was recovering at the time of this report. The patient had rotavirus screen done, result not provided. The patient sought unspecified medical attention. Follow up information has been received from a licensed practical nurse. The patient with no drug allergies or pertinent medical history was vaccinated with the first dose of ROTATEQ (lot # 63846/0067Y). There was no illness at the time of vaccination. The patient was vaccinated with the second dose of ROTARIX (lot number A41FA859A) on 09-JUL-2009. It was reported that on 08-FEB-2011 at 05:30 the patient experienced vomiting and yellow diarrhea. The same day, at 14:40 the patient presented temperature and loose stools with foul odor. The licensed practical nurse reported that the patient was exposed to rotavirus at the daycare. On 12-FEB-2011 the patient recovered from temperature and diarrhea. On 14-FEB-2011 the patient recovered from vomiting and yellow diarrhea (also reported as 12-FEB-2011). The patient required a doctor visit (also reported as no medical attention required). No further information is expected.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a 13 weeks 6 days old male patient who on 14-FEB-2011 was vaccinated with his first dose of 2 ml ROTATEQ (lot # not reported). No adverse effect reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 0.31
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a 16 weeks old male patient who on 17-DEC-2010 was administered the first dose of ROTATEQ (Lot # and expire date not reported), per oral. No adverse symptoms were reported. It was unknown if the patient sought medical attention. No further information is available.
Age: 0.76
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning a 9 month old male patient who was vaccinated orally with the first and second dose of ROTATEQ on 14-SEP-2010 and 28-MAR-2011 respectively (lot# not specified). No adverse effects were reported. Follow up information has been received from a Certified Pediatric Nurse Practitioner, concerning a 9 month old male patient with "none" pertinent medical history, "none" drug allergies or reactions, who was vaccinated orally with the first and second dose of ROTATEQ on 14-SEP-2010 (lot# not specified) and 28-MAR-2011 (lot# 668967/1201Z, expiration date: August 2012) respectively. There were "none" concomitant therapies. The nurse reported that on 28-MAR-2011, the patient was given his 6 months vaccines at 9 months old. After given his ROTATEQ, was noticed he was 36 weeks old, when he should had gotten it at 24 weeks. No further information is available.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Pyrexia, Rotavirus test
Clinical narrative: Information has been received from a physician concerning a 9 weeks female patient, who on 23-FEB-2011 was vaccinated with a dose of ROTATEQ (Lot # 669073/1525Z) orally. The physician reported that on 25-FEB-2011, "two days later" vaccination, the patient experienced watery stool and low grade fever. A stool roto test was performed (results not provided). It was reported that the patient had not received treatment for the adverse event. The patient sought medical attention. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 0.13
Sex: U
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a Registered Nurse concerning a 48 day old patient with a history of vomiting and "none" drug reactions or allergies who on 22-MAR-2011 was vaccinated orally with the first 2 ml dose ROTATEQ (lot # unspecified). Suspect therapy included HepB (manufacturer unknown) (dose, route and lot# unspecified). Concomitant therapy included PREVNAR and PENTACEL. The nurse reported that after receiving the first dose of ROTATEQ, the patient vomited a short time (while still in the exam room while the patient was being dressed). No treatment was given to the patient. No lab diagnostic studies were performed. At the time of the report the patient's status was not reported. The patient sought medical attention, as adverse event occurred in the physician's office. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient who on approximately 20-APR-2011 was vaccinated with the first dose of ROTATEQ. On 06-JUL-2011 the patient experienced received the second dose vaccine 11 weeks later. The nurse reported that the patient was in the office on 06-JUL-2011 for a second dose of ROTATEQ and the first dose was administered 11 weeks ago. The nurse did not think the patient was going to continued the series. No adverse effect was reported. It was unknown if the patient sought medical attention. Additional information is not expected.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Dehydration, Diarrhoea, Rotavirus infection, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning a 22 month old female with no drug allergies and no medical history who in approximately October 2009 (about 20 months ago), was vaccinated with a dose of ROTATEQ orally according to the prescribed schedule (dose/frequency reported as "3-dose/between 6 and 12 weeks of age"). In April 2011, the patient experienced contracted rotavirus and was dehydrated from diarrhea. it was tested positive for rotavirus. Patient was treated with oral rehydration. And the adverse events improved. On an unspecified date, the patient recovered from contracted rotavirus and dehydrated from diarrhea. No further information is available.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning an approximately 16 weeks (reported as "4 months") patient who on an unspecified date was vaccinated with the first and second dose of ROTATEQ. On an unspecified date, the patient developed hives. It was unspecified whether the patient sought medical attention. Upon the time of the report, the patient's present status was unknown. No further information is available.
Age: 0.16
Sex: M
Vaccine: RV5
Symptoms: Oral administration complication, Vomiting
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 60 days old male infant with a history of premature baby 33 weeks who on 04-APR-2011 was vaccinated with the first dose of ROTATEQ (lot# 669072/1270Z, dose not reported). The patient spit up the dose within 30 seconds of receipt. The patient sought medical attention. At the time of reporting, the patient had recovered. Follow up information has been received from a physician concerning the child with no illness at time of vaccination who on 04-APR-2011 at 12:00, was vaccinated with ROTATEQ and threw up the vaccine at 12:00 PM. Physicians were called to see if the dose was needed to repeat. The physician did not repeat it. The patient was 100% fine and recovered after he threw up. No ER visit was request. Additional information is not expected.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Oral administration complication, Vomiting
Clinical narrative: Information has been received from a Licensed Practical Nurse, concerning a 60 days old female patient, with no pertinent medical history reported, who on 29-APR-2011 was vaccinated orally, with her first dose of ROTATEQ (Lot #: 665161/1632Y) (Dose not reported). Concomitant therapy included PENTACEL, PREVNAR 13 and ENGERIX-B. Licensed Practical nurse reported that the patient vomited immediately after receiving her first dose of ROTATEQ. No treatment was given for the event. The patient sought unspecified medical attention. The adverse event occurred in the physicians office. No lab/diagnostic studies were performed. At the time of the report, the patient's outcome was unknown.  Follow-up information has been received from the licensed practical nurse, concerning a 60 days "8 weeks" old (also reported as new born), female patient, with no pre-existing allergies, birth defects or medical conditions reported, who on 29-APR-2011 at approximately 11:00 am was vaccinated orally with her first dose of ROTATEQ (Lot #: 665161/1632Y) (Dose not reported). There was no illness at the time of vaccination. Concomitant vaccination received on the same day, at approximately 11:00 am, included the first dose intramuscularly in the left thigh of PENTACEL (Lot #: C3715AA), the first dose, intramuscularly in the right thigh of PREVNAR 13 (Lot#: E56496) and the second dose intramuscularly in the left deltoid, of ENGERIX-B (Lot #: AHBVB845AA). Licensed practical nurse reported that patient immediately vomited following administration of ROTATEQ. She reported that patient was receiving formula when entered room for vaccine administration and was "bumped" prior to vaccines. No lab/diagnostic studies were performed. The patient did not seek medical attention. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Infantile spitting up
Clinical narrative: Information has been received from a licensed practical nurse concerning a 10 weeks old female patient with no pertinent medical history and no drug allergy or reaction who on 18-AUG-2011 was vaccinated with the first dose for ROTATEQ (Lot Number not reported). Concomitant therapy included PEDIARIX, PREVNAR and Hib conj vaccine (unspecified carrier) received on the same day. On 18-AUG-2011 the patient spitted up after receiving her first dose of ROTATEQ in the office. No lab diagnostic study was performed. On an unspecified date, the patient recovered. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning an approximately 16 week old ("4 month old") male patient who received his first, second and third doses of ROTATEQ (lot # 669830/0078AA, EXP 31-OCT-2012) on 06-JUN-2011, 23-AUG-2011 and 31-AUG-2011, respectively. No adverse symptoms reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 0.6
Sex: M
Vaccine: RV5
Symptoms: Vomiting projectile
Clinical narrative: Information has been received from a reporter at a physician's office concerning a 24 week old male patient who was a premature baby, was on oxygen prior, had a respiratory disease and was an intensive care unit (ICU) patient. Two months ago (on approximately 06-OCT-2011), the patient was vaccinated orally with the first dose of ROTATEQ (lot number and dose not reported). There was no concomitant therapy. The reporter stated that the patient came in for his first dose of ROTATEQ and he experienced projectile vomiting, no blood or anything (the AE onset date also reported as "about 2 month ago", approximately in October 2011). It was unknown of the patient sought medical attention. No treatment was given for the event and no lab diagnostic tests were performed. at the time of the report the patient was recovered. This is one of several reports received from the same source. No further information is available.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Infantile spitting up, Irritability, Pyrexia, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 8 week old male patient with no drug reactions/allergies and no pertinent medical history who on 06-JAN-2012, was vaccinated with a first dose of ROTATEQ, (lot number 668906/1476Z, expiration date 01-AUG-2012), (dose, route not reported). Concomitant therapy included PREVNAR 13 and PENTACEL given in 06-JAN-2012, at the same office visit as administration of the first dose of ROTATEQ. On 06-JAN-2012, the patient developed a fever shortly after his first vaccination with ROTATEQ. The fever resolved on 09-JAN-2012. In January 2012, the patient then became fussy and was spitting up. On 11-JAN-2012, the patient began to vomit. There was no treatment given for becoming fussy, spitting up and vomiting. At the time of the report the patient's outcome was not recovered. No laboratory diagnostics studies were performed. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a consumer concerning about her 24 weeks old son (currently 36 weeks old) who in July 2011 and November 2011, was vaccinated with 2 ml a first and a second doses respectively, of ROTATEQ (Lot # and route unknown). The consumer report that her son received his first dose at 2 months old and got the second dose at 6 months old (in November 2001). At the time of the report the baby was 9 months old and it was too old to received the third dose of ROTATEQ. There was no adverse reaction reported. Additional information has been requested.
Age: 0.45
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 23 week old patient who on 30-JUL-2010, was vaccinated with a first dose of ROTATEQ, oral (dose and lot number not reported). On 10-NOV-2010, the patient received a second dose of ROTATEQ, oral (dose and lot number not reported). On 10-JAN-2012, the patient received a third dose of ROTATEQ, oral (dose and lot number not reported). No known adverse effect. Follow-up information has been received from a registered nurse (R.N.) concerning a 23 week old male patient, birth weight 6 pounds 13 ounces, with 1 sibling, with recurrent upper respiratory infections, possible asthma, recurrent otitis media and left serous otitis at time of vaccination, with no adverse events following prior vaccination, who 10-JAN-2012, at 11:30 AM, was vaccinated with a third dose of ROTATEQ (lot number 1303AA), oral, (dose not reported). Concomitant therapy included his fourth dose of PENTACEL and his fourth dose of PREVNAR 13. No adverse event reported. The patient did not seek medical attention. There were no lab diagnostic studies performed. Additional information has been requested.
Age: 0.25
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a 13 week old male patient who on 12-DEC-2011 was vaccinated with the first dose of ROTATEQ (lot #, dose and route not reported). On 04-JAN-2012 the patient was vaccinated with the second dose of ROTATEQ (lot #, dose and route not reported) too early. She stated that no adverse experience had been observed or reported. It was unspecified if the patient sought medical attention. Additional information has been requested.