chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 practitioner concerning a 20 weeks and 2 days old patient who on 06-DEC-2011 was vaccinated with the first dose of ROTATEQ, 2ml, orally (lot number not reported). The nurse reported, that it was off schedule. No adverse effects were reported. Additional information has been requested.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Haematochezia, Mucous stools, Pain
Clinical narrative: Information has been received from a physician concerning a 58 days old male patient with no known drug allergies and no pertinent medical history who on 27-DEC-2011, was orally vaccinated with the first dose of ROTATEQ (Lot# 671724/1543AA, expiration date: 12-JUN-2013), (dose not reported. Secondary suspect therapy also included a dose of RECOMBIVAX (manufacturer, route and lot number unknown). Concomitant therapy included a dose of PENTACEL, a dose of PREVNAR. The physician reported that on 28-DEC-2011, the patient experienced blood in his stool after administration of his first dose of ROTATEQ. He had blood and mucus in stools four times. No treatment was given for blood and mucus in stools. It was also reported that the patient experienced some pain from other immunizations: PENTACEL, PREVNAR and RECOMBIVAX (manufacturer unknown) which the patient had received during the same visit. Patient was treated with TYLENOL. Patient sought medical attention by visiting physician's office. None lab diagnostic studies were performed. On 28-DEC-2011, patient recovered from blood and mucus on stool. The patient's outcome for pain was unknown. Additional information has been requested.
Age: 0.35
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning 18 week old patient who in October 2011, was vaccinated with a first dose of ROTATEQ, (dose, route, lot number were not reported). It was reported that the patient was given the second dose of ROTATEQ on 12-DEC-2011. The patient was given the third dose of ROTATEQ early on 28-DEC-2011, (lot number 16592 is an invalid number for ROTATEQ, expiration date 06-DEC-2012). No adverse reactions reported. The patient did not seek medical attention. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Infantile spitting up, Oral administration complication
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a 2 month old female patient with no drug reactions/allergies and no pertinent medical history who on 12-JAN-2012, was vaccinated with a first dose of ROTATEQ, oral, (lot number 670539/0678AA, expiration date 15-MAR-2013), (dose not reported) and spitted it up. There was no treatment given for spitting up. At the time of the report the patient's outcome was unknown. The patient did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Infantile spitting up, Oral administration complication
Clinical narrative: Information has been received from a nurse concerning a patient who on 02-FEB-2012, was vaccinated with a dose of ROTATEQ (lot# and dose not reported) and spit up the ROTATEQ after it was administered. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a now 15 month old patient who was vaccinated with the first, second and third dose of ROTATEQ (lot# unspecified) by oral on 28-DEC-2010, 14-MAR-2011 and 27-APR-2011 (approximately at 6 month old). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Emotional distress, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning an infant who on approximately 23-NOV-2011, was vaccinated with a dose of ROTATEQ, 2 ml, orally (lot number not reported). Concomitant therapy included PEDIARIX, PREVNAR and Hib conj vaccine (unspecified carrier). A day later, 2 months ago, on approximately 24-NOV-2011, the patient experienced vomiting, diarrhoea, low grade fever and was inconsolable. The parents were told by the doctor to take the infant to the emergency room. It was also reported that the patient sought medical attention by phone. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 0.1
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning a 35 day old patient who in December 2011, was vaccinated with the first dose of ROTATEQ (dose and lot number not reported), PO. No adverse effects were reported. No further information is available.
Age: 0.4
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 29-AUG-2011 was vaccinated with the first dose of ROTATEQ (lot # not provided). The physician refused to provide any specific patient data. No adverse effects reported. Additional information has been requested. This is a an amended report. The reporting status was changed from do not send to periodic.
Age: 0.79
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse practitioner concerning a 9 month old child who on 07-FEB-2011, was vaccinated orally with the first 2 ml dose of ROTATEQ (lot # not provided) and the third dose at the age of 9 months (on approximately 03-SEP-2011). No adverse effect was known. The patient did not seek medical attention. Follow up information was received from an advanced practice nurse (APN) concerning a 9 month old male patient with no pre-existing allergies, birth defects or medical conditions who on 16-SEP-2011 (previously reported as at the age of 9 months), was vaccinated orally with the third dose of ROTATEQ (lot # 110078AA was not valid for ROTATEQ. The nurse reported that this mistake was realized after the patient had left the clinic. No adverse event was reported. The patient had been seen 3 times since the event. No further information is available.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 22 week old patient who on 09-SEP-2011 was vaccinated orally with the first 2 ml dose of ROTATEQ (Lot number not reported). No adverse symptoms noted. Additional information has been requested.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Haematochezia, Milk allergy, Occult blood positive
Clinical narrative: Information has been received from a physician concerning a 12 weeks old female patient with no pertinent medical history or drug allergies who on 25-MAY-2011 was vaccinated orally with a dose of ROTATEQ (Lot#: 669523/1556Z). There was no concomitant medication. On 07-JUN-2011 (reported as 13 days after therapy), the patient experienced hematochezia. There was no lab diagnostics performed. The patient did not seek medical attention. At the time of the report, the patient had recovered. Follow up information has been received from a registered nurse who stated that on 25-MAY-2011, the patient received the first dose of ROTATEQ (Lot #: 669523/1556Z), and concomitantly received the second dose of RECOMBIVAX HB (Lot#: 668062/0979Z) and received the first dose of PREVNAR 13 and the first dose of PENTACEL. On 27-MAY-2011, the patient's mother reported that the patient had bloody stools with red streaks. The patient's stools tested positive for blood. The patient's mother was advised to male some dietary changes for the patient. On 23-JUN-2011, the bloody stools persisted. In July 2011, the physician felt that the patient's bloody stools were the result of a milk allergy. The patient was placed on Alimentum formula. The patient had not had bloody stools since she was placed on the Alimentum formula. The patient recovered. The physician discontinued ROTATEQ (Lot #: 669523/1556Z). Additional information was received from a physician regarding a 9 week old (previously reported as 12 week old) female patient who on 25-MAY-2011 received a first dose of ROTATEQ PO (Lot#: 669523/1556Z), and concomitantly received the second dose of RECOMBIVAX HB (Lot #: 668062/0979Z) IM in LAT, and received the first dose of PREVNAR 13 (Wyeth) (lot #: E84910) IM in RAT, and the first PENTACEL (Sanofi Pasteur) (Lot #: C3869AA for DTaP-IPV component and lot# C3724AA for ACTHIB component) IM in LAT. Subsequently, on 26-MAY-2011, the patient experienced blood in stool. The patient was recovered from this event on approximately 03-JUN-2011. At the time of this report, the patient was reported as 7 months old. All available medical records will be provided upon request. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Bacterial test negative, Diarrhoea, Escherichia infection, Haematochezia, Immediate post-injection reaction
Clinical narrative: Information has been received from a physician concerning a patient who within the last month (in September 2011), was vaccinated with a dose of ROTATEQ (Lot # not reported). It was reported that immediately following the dose, the patient had excessive diarrhea. The physician did multiple tests to rule out other illness and no one in the patient's family had been ill at that time. The physician stated that it took several weeks for the diarrhea to clear up. Follow up information has been received from physician, concerning an approximate 17 weeks female patient who on 31-AUG-2011 was vaccinated orally with the second dose of ROTATEQ (Lot number 669992/0287AA). Concomitant vaccine given on the same day included the second dose of PREVNAR (Lot number 916973) administered in the left arm and the second dose of PENTACEL (Lot number C3796AA) administered in the right arm. The physician indicated that that patient presented between 01-SEP-2011 or 02-SEP-2011 with diarrhea for 1 month, watery, 4 to 5 stools per day, there was blood on single occasion; onset shortly after 4 hours given ROTATEQ. E. coli urinary tract infection (UTI) developed 2 weeks after onset. On 20-SEP-2011, the following lab tests were taken: Campylobacter culture (No enteric Campylobacter isolated), stool Escherichia coli 0157:H7 culture (No detected), stool Salmonella and Shigella culture (No Salmonella or Shigella isolated), Rotavirus Ag (Negative), Red subst, faces (1+), stool occult blood test (Negative ), Giardia EIA (Negative), Cryptosporidium EIA (Negative) and histolytics Stool EIA (Negative). It was reported that the patient did not seek medical attention. In October 2011, the patient recovered from the events. No further information is available.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Occult blood negative, Parasite blood test, Parasite stool test negative, Rotavirus test negative, Stool analysis abnormal
Clinical narrative: Information has been received from a physician concerning a patient who within the last month (in September 2011), was vaccinated with a dose of ROTATEQ (Lot # not reported). It was reported that immediately following the dose, the patient had excessive diarrhea. The physician did multiple tests to rule out other illness and no one in the patient's family had been ill at that time. The physician stated that it took several weeks for the diarrhea to clear up. Follow up information has been received from physician, concerning an approximate 17 weeks female patient who on 31-AUG-2011 was vaccinated orally with the second dose of ROTATEQ (Lot number 669992/0287AA). Concomitant vaccine given on the same day included the second dose of PREVNAR (Lot number 916973) administered in the left arm and the second dose of PENTACEL (Lot number C3796AA) administered in the right arm. The physician indicated that that patient presented between 01-SEP-2011 or 02-SEP-2011 with diarrhea for 1 month, watery, 4 to 5 stools per day, there was blood on single occasion; onset shortly after 4 hours given ROTATEQ. E. coli urinary tract infection (UTI) developed 2 weeks after onset. On 20-SEP-2011, the following lab tests were taken: Campylobacter culture (No enteric Campylobacter isolated), stool Escherichia coli 0157:H7 culture (No detected), stool Salmonella and Shigella culture (No Salmonella or Shigella isolated), Rotavirus Ag (Negative), Red subst, faces (1+), stool occult blood test (Negative ), Giardia EIA (Negative), Cryptosporidium EIA (Negative) and histolytics Stool EIA (Negative). It was reported that the patient did not seek medical attention. In October 2011, the patient recovered from the events. No further information is available.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Urinary tract infection bacterial
Clinical narrative: Information has been received from a physician concerning a patient who within the last month (in September 2011), was vaccinated with a dose of ROTATEQ (Lot # not reported). It was reported that immediately following the dose, the patient had excessive diarrhea. The physician did multiple tests to rule out other illness and no one in the patient's family had been ill at that time. The physician stated that it took several weeks for the diarrhea to clear up. Follow up information has been received from physician, concerning an approximate 17 weeks female patient who on 31-AUG-2011 was vaccinated orally with the second dose of ROTATEQ (Lot number 669992/0287AA). Concomitant vaccine given on the same day included the second dose of PREVNAR (Lot number 916973) administered in the left arm and the second dose of PENTACEL (Lot number C3796AA) administered in the right arm. The physician indicated that that patient presented between 01-SEP-2011 or 02-SEP-2011 with diarrhea for 1 month, watery, 4 to 5 stools per day, there was blood on single occasion; onset shortly after 4 hours given ROTATEQ. E. coli urinary tract infection (UTI) developed 2 weeks after onset. On 20-SEP-2011, the following lab tests were taken: Campylobacter culture (No enteric Campylobacter isolated), stool Escherichia coli 0157:H7 culture (No detected), stool Salmonella and Shigella culture (No Salmonella or Shigella isolated), Rotavirus Ag (Negative), Red subst, faces (1+), stool occult blood test (Negative ), Giardia EIA (Negative), Cryptosporidium EIA (Negative) and histolytics Stool EIA (Negative). It was reported that the patient did not seek medical attention. In October 2011, the patient recovered from the events. No further information is available.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Immediate post-injection reaction, Vomiting
Clinical narrative: Information has been received from a medical assistant concerning an 8 weeks female with no drug allergy and no medical history who on 10-AUG-2011 was vaccinated orally with her first dose of ROTATEQ, 2ml. There was no concomitant medication. The reporter stated that immediately following administration, the patient vomited on 10-AUG-2011. The reporter was unsure whether or not the patient got the full dose. No treatment was given for AE. The patient did not undergo any lab diagnostics studies. The patient was in office to seek medical attention. The patient recovered on 10-AUG-2011. Additional information has been requested.
Age: 0.35
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a 4 month old patient who on 23-MAY-2011, was vaccinated with the first dose of ROTATEQ (dose, route and lot number not reported). There were no adverse events to report. The patient did not seek medical attention. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: PNC, RV5
Symptoms: Abnormal behaviour, Bruxism, Dyskinesia, Personality change
Clinical narrative: Information has been received from a physician concerning an 18 weeks male patient, who approximately on 01-JUL-2011, when he was 10 weeks, was vaccinated with the first dose of ROTATEQ (Lot #, dose and route not reported), then on 02-SEP-2011, when he was 18 weeks, the patient was vaccinated with the second dose of ROTATEQ (Lot #, dose and route not reported). Concomitant therapy included PREVNAR on 02-SEP-2011. The physician reported that on 02-SEP-2011, one hour after receiving the second dose, the patient acted odd, out of character, clenching his jaw and moving his head according to the patient's mother. The physician stated that the patient sought unspecified medical attention by calling the physician. The patient was no given any treatment for the events. On 02-SEP-2011, the symptoms resolved on their own after fifteen minutes. No further information is available.
Sex: U
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning an infant who on 03-OCT-2011, was vaccinated with a dose of ROTATEQ (lot # and dose not reported). The physician reported that on 03-OCT-2011 the patient vomited shortly after receipt of the vaccine. It was unknown if the patient sought medical attention. At the time of the report the outcome of the patient was unknown. Additional information has been requested.
Age: 0.25
Sex: F
Vaccine: RV5
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a physician concerning an approximately 13 weeks old female patient who on an unspecified date was vaccinated orally with the first 2 ml dose of ROTATEQ. On approximately 10-OCT-2011 (reported as "about two weeks ago"), the patient experienced pedal edema. The patient sought unspecified medical attention. It was reported that the patient was on therapy and recovered from pedal edema. Additional information has been requested.
Age: 0.6
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient who at 8 months and 28 days was vaccinated orally with the third 2 ml dose of ROTATEQ (lot # not reported). No adverse effect reported. No further information is available.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Decreased appetite, Infrequent bowel movements
Clinical narrative: Information has been received from a certified nurse practitioner concerning an 8 week old patient with a history of Hirschsprung's disease that was repaired (unspecified repair), who "about two weeks ago" on approximately 20-SEP-2011 was vaccinated with a dose of ROTATEQ (dose, route and lot # not reported). The nurse reported that about two weeks ago, on approximately 20-SEP-2011 the patient developed slowed down bowel movements and a loss of appetite after receiving ROTATEQ. The development of slowed down bowel movements and loss of appetite occurred shortly after the vaccine was administered. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Cough, Diarrhoea, Haematochezia, Mucous stools, Viral infection
Clinical narrative: Information has been received from a physician concerning a 9 week old female with no pertinent medical history and no drug reactions or allergies who on 10-DEC-2010 was vaccinated with a dose of ROTATEQ (lot # 668264/0854Z). There was no concomitant medication. On 10-DEC-2010 the patient experienced hematochezia after receiving ROTATEQ. The patient sought unspecified medical attention. No lab diagnostics studies were performed. At the time of the report, the patient had recovered. Follow-up information was from a registered nurse indicating that on 10-DEC-2010, the patient received the first dose of ROTATEQ (lot # 668264/0854Z) and concomitantly received the second dose of RECOMBIVAX HB (Lot # 666186/1483Y, thimerosal free) and received the first dose of PREVNAR 13 and the first dose of PENTACEL. On the evening of 10-DEC-2010, the patient's mother reported that the patient had blood streaks in her stools and mucus in her stools. The patient's mother was advised to have the patient be seen by the physician if the blood and mucus in her stools persisted. There was no documentation which indicted that the patient had a follow-up appointment due to blood and mucus in her stools. The R.N. stated that there were no issues of bloody stools that followed. The R.N. stated that the patient had recovered. The physician had discontinued ROTATEQ. On 18-JAN-2011, the patient was seen by the physician for cough, vomiting and watery stools. The R.N. stated that the patient was diagnosed with a virus (not specified). Follow-up information has been received from a physician and medical records indicating that a two month old female who on 10-DEC-2010, received the first dose of ROTATEQ (lot # 668264/0854Z) and concomitantly received the second dose of RECOMBIVAX HB (Lot # 666186/1483Y, thimerosal free), the first dose of PREVNAR 13 and the first dose of PENTACEL. On 10-DEC-2010, the patient experienced blood in stool. The patient recovered on approximately 15-DEC-2010. The second and third doses of ROTATEQ were not given. At the time of the report, the outcome of virus (not specified) was not reported. This is one of several reports received from the same source. All available medical records will be provided upon request. Additional information is not expected.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 9 week old female with no pertinent medical history and no drug reactions or allergies who on 10-DEC-2010 was vaccinated with a dose of ROTATEQ (lot # 668264/0854Z). There was no concomitant medication. On 10-DEC-2010 the patient experienced hematochezia after receiving ROTATEQ. The patient sought unspecified medical attention. No lab diagnostics studies were performed. At the time of the report, the patient had recovered. Follow-up information was from a registered nurse indicating that on 10-DEC-2010, the patient received the first dose of ROTATEQ (lot # 668264/0854Z) and concomitantly received the second dose of RECOMBIVAX HB (Lot # 666186/1483Y, thimerosal free) and received the first dose of PREVNAR 13 and the first dose of PENTACEL. On the evening of 10-DEC-2010, the patient's mother reported that the patient had blood streaks in her stools and mucus in her stools. The patient's mother was advised to have the patient be seen by the physician if the blood and mucus in her stools persisted. There was no documentation which indicted that the patient had a follow-up appointment due to blood and mucus in her stools. The R.N. stated that there were no issues of bloody stools that followed. The R.N. stated that the patient had recovered. The physician had discontinued ROTATEQ. On 18-JAN-2011, the patient was seen by the physician for cough, vomiting and watery stools. The R.N. stated that the patient was diagnosed with a virus (not specified). Follow-up information has been received from a physician and medical records indicating that a two month old female who on 10-DEC-2010, received the first dose of ROTATEQ (lot # 668264/0854Z) and concomitantly received the second dose of RECOMBIVAX HB (Lot # 666186/1483Y, thimerosal free), the first dose of PREVNAR 13 and the first dose of PENTACEL. On 10-DEC-2010, the patient experienced blood in stool. The patient recovered on approximately 15-DEC-2010. The second and third doses of ROTATEQ were not given. At the time of the report, the outcome of virus (not specified) was not reported. This is one of several reports received from the same source. All available medical records will be provided upon request. Additional information is not expected.
Age: 0.6
Sex: M
Vaccine: RV5
Symptoms: Eructation, Flatulence, Nausea, Retching
Clinical narrative: Information has been received from a physician concerning a 7 month old male patient with perforated anus and G-tube who on approximately 05-SEP-2011 was vaccinated with ROTATEQ (lot # not reported). On approximately 08-SEP-2011 (reported as "approximately three days following the vaccination") the patient began experiencing nausea, retching and burping up more gas than usual. At the time of reporting, the patient had not recovered. The patient sought medical attention via office visit. Additional information has been requested.
Age: 0.18
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Oral administration complication, Vomiting
Clinical narrative: Information has been received from a certified medical assistant concerning a 9 weeks old female patient with no pertinent medical history and no drug allergy or reaction who on 17-OCT-2011 was vaccinated with the first dose of ROTATEQ (Lot number not reported) orally. On 17-OCT-2011 the patient experienced vomited in the office after receiving her first dose of ROTATEQ. At the time of the report, the patient's present status was unknown. Follow-up information has been received from a physician concerning the patient who on 17-OCT-2011 3:00 PM was vaccinated with the first dose of ROTATEQ (lot # 12011Z is an invalid lot number for ROTATEQ) orally. The physician reported that there was no adverse event. The patient spit out dose on 17-OCT-2011 3:00 PM. The physician checked to see if needed to be repeated. It was reported answer was no. Emergency room or doctor visit was not required. No further information is available.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Haematochezia, Occult blood positive
Clinical narrative: Information has been received from a physician concerning an 9 week old male patient with no medical history and no drug reactions/allergies who on 06-OCT-2011 was vaccinated with ROTATEQ (lot #669992/0287AA, Exp 15-NOV-2012). There was no concomitant medication. On 07-OCT-2011 the patient's mom called the office with a report of blood in the stool. No treatment was given for adverse events. Lab diagnostics studies were not performed. At the time of the report, the patient had not recovered from blood in the stool. The physician contacted during telephone follow-up could not supply the following information: patient's full name and recovery status. She did comment that the stool tested heme positive. She could not recall if the baby had any other symptoms, but did not think so. The event was thought to be due to diet rather than the vaccine. Status as of 14-OCT-2011 was unknown. No further information is available.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Vomiting projectile
Clinical narrative: Information has been received from a doctor of osteopathy concerning a 60 day old male patient who on an unspecified date was orally vaccinated with 2 mL of the first dose of ROTATEQ (Lot # and expiration not reported). On an unspecified date the patient had projectile vomit. Patient did not seek medical attention. No treatment was given for this adverse event. On an unspecified date the patient recovered. Follow up information was received from the doctor of osteopathy who reported that he recommended a consult with a gastrointestinal (GI) specialist for the patient and ordered a liver function test and rotavirus test but the patient did not follow up with the GI specialist and did not have the tests performed. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Cold sweat, Crying, Irritability, Product taste abnormal, Rash macular
Clinical narrative: Information has been received from a licensed nurse practitioner concerning an 8 week old female with no drug allergy and no medical history who on 19-OCT-2011 was vaccinated with a dose of ROTATEQ, 2 ml (lot# 668905/0560AA, expiration 30-JUN-2012). There was no concomitant medication. The nurse reported that on 19-OCT-2011, during administration, the patient made a "horrible gaggy face", and the baby gagged. The patient also screamed and cried during administration. The patient's skin became cool and clammy after the patient received the dose of ROTATEQ. No treatment was given for the AEs. No lab diagnostics studies were performed. The patient was seen and assessed by the nurse practitioner. Nurse suspected a quality issue with this vaccine as this is one of two doses that were administered from this same lot and expiration. The nurse requested a lot check for ROTATEQ (lot # 0560AA expiration 30-JUN-2012). Product quality complaint involved. The follow-up information has been received from the licensed nurse practitioner concerning the patient, a two month old female who at AM of 19-OCT-2011 was vaccinated with her first dose of ROTATEQ. The nurse reported that the patient became clammy and skin was blotchy and cold after vaccination at AM of 19-OCT-2011. During administration, the patient was very fussy and made faces like ROTATEQ tasted bad. The patient also screamed and gagged. The patient recovered on 19-OCT-2011. The patient had no illness at time of vaccination. The patient had no pre-existing allergies, birth defects or medical conditions. The follow-up information has been received from the licensed nurse practitioner concerning the patient, a 8 weeks old female who at AM of 19-OCT-2011 was vaccinated with her first dose of ROTATEQ. The nurse reported that during ROTATEQ was administered orally, the patient became fussy and made horrible gaggy face and gagged as if going to vomit. The patient screamed and moved head side to side. The patient's skin became cold and clammy. The nurse practitioner evaluated the patient. No relevant diagnostic tests were performed. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Drug Evaluation and Research and was released. This is one of several report received from the same source. No further information is available.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Retching, Screaming
Clinical narrative: Information has been received from a licensed nurse practitioner concerning an 8 week old female with no drug allergy and no medical history who on 19-OCT-2011 was vaccinated with a dose of ROTATEQ, 2 ml (lot# 668905/0560AA, expiration 30-JUN-2012). There was no concomitant medication. The nurse reported that on 19-OCT-2011, during administration, the patient made a "horrible gaggy face", and the baby gagged. The patient also screamed and cried during administration. The patient's skin became cool and clammy after the patient received the dose of ROTATEQ. No treatment was given for the AEs. No lab diagnostics studies were performed. The patient was seen and assessed by the nurse practitioner. Nurse suspected a quality issue with this vaccine as this is one of two doses that were administered from this same lot and expiration. The nurse requested a lot check for ROTATEQ (lot # 0560AA expiration 30-JUN-2012). Product quality complaint involved. The follow-up information has been received from the licensed nurse practitioner concerning the patient, a two month old female who at AM of 19-OCT-2011 was vaccinated with her first dose of ROTATEQ. The nurse reported that the patient became clammy and skin was blotchy and cold after vaccination at AM of 19-OCT-2011. During administration, the patient was very fussy and made faces like ROTATEQ tasted bad. The patient also screamed and gagged. The patient recovered on 19-OCT-2011. The patient had no illness at time of vaccination. The patient had no pre-existing allergies, birth defects or medical conditions. The follow-up information has been received from the licensed nurse practitioner concerning the patient, a 8 weeks old female who at AM of 19-OCT-2011 was vaccinated with her first dose of ROTATEQ. The nurse reported that during ROTATEQ was administered orally, the patient became fussy and made horrible gaggy face and gagged as if going to vomit. The patient screamed and moved head side to side. The patient's skin became cold and clammy. The nurse practitioner evaluated the patient. No relevant diagnostic tests were performed. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Drug Evaluation and Research and was released. This is one of several report received from the same source. No further information is available.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Product taste abnormal, Screaming
Clinical narrative: Information has been received from a L.P. nurse concerning a 9 week old male with a history of haemangioma on the face and no allergies who on 19-OCT-2011 was vaccinated orally with a dose of 2 ml ROTATEQ (lot #: 668905/0560AA, exp. : 30-JUN-2012). There was no other concomitant medication. Nurse reported that on 19-OCT-2011 during administration of a dose of the vaccine the patient screamed continuously and made a face that would indicate that the taste of the vaccine was unpleasant. Nurse reported that the patient did not vomit. Nurse reported that the patient's symptoms completed resolved. Nurse suspected a quality issue with this dose of the vaccine because this was one of two patients who received doses of the vaccine from this same lot and expiration (see WAES # 1110USA02941). No lab diagnostic studies perform and no treatment given for AE. The patient was recovered. A lot check has been initiated. This is one of several reports received from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Ear discomfort, Haemorrhage, Irritability
Clinical narrative: Information has been received via medical records concerning a 9 week old female with gastroesophageal reflux disease, no known allergies and a history of jaundice neonatal, group B streptococcus (GBS) positive and oral thrush who on 10-JUN-2010 was vaccinated orally with the first dose of ROTATEQ (lot # 664945/0147Z). Suspect therapy given on the same day included the first dose of PENTACEL (lot # C3591AA) given IM in the right thigh, the second dose of hepatitis B (unspecified) (lot # AHBUB6KAA) given IM in the left upper thigh and PREVNAR (lot # E44433) given IM in the left lower thigh. On 11-JUN-2010 the patient was seen in the office presenting with fussy, pulling at ear. It was reported that mom found two tiny spots of pink blood in the front of her diaper in the morning around 11:00. The location was right ear. The onset was sudden, 1 day ago (on 10-JUN-2010). There were relieving factors including TYLENOL. Associated symptoms included fussy and no other symptoms. The patient got 2 month immunizations "yesterday". The patient continued to take PO well. Mom had not noted any blood in the diaper before or since the one incident. All the review of systems was negative. No findings were noticed in the physical examination. The patient was diagnosed as fussy infant, which was "likely secondary to receiving immunizations yesterday". The patient was instructed to follow up and return to the office (RTO) if any acute changes, or no improvement by "Monday" (14-JUN-2010), monitor closely for any further signs of blood in the diaper and call or RTO if positive. This is one of several reports received from the same source. Additional information is not expected.
Age: 0.52
Sex: M
Vaccine: RV5
Symptoms: Adverse event, Erythema multiforme, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 6 1/2 month old male patient with no allergies or drug reactions and no pertinent medical history who on an unspecified date was orally vaccinated with 2 mL of the third dose of ROTATEQ (Lot# and expiration not reported). There was no concomitant medication. Nurse reported that the patient was administered ROTATEQ and 24 hours post vaccination developed erythema multiforme. Nurse stated that the third dose was not administered with any other medications. No laboratories were performed. The patient sought the physician. No treatment was given for this adverse event. The patient recovered on an unspecified date. Follow-up information has been received from a registered nurse concerning a mixed (AA/C) 16 week old patient, with no known illness at the time of vaccination, who on 20-MAY-2011 was vaccinated with a second dose of ROTATEQ (Lot #, dose and route not reported), a second dose of PENTACEL (lot # dose and route not reported) and a second dose of PREVNAR 13 (lot # dose and route not reported) and on 26-JUL-2011 at 11:30 am he was vaccinated with the third dose of ROTATEQ (Lot # 669963/1724Z). Vaccine given within 4 weeks of MERCK vaccination included PENTACEL (lot# C3840AA) L thigh at 1:00pm and PREVNAR 13 (lot #E97569) R thigh at 1:00 pm. The registered nurse reported that on 27-JUL-2011 the parents noticed 2-3 mosquito size bumps (late pm). On 28-JUL-2011 the bumps changed in color looking dusky in the center and multiplied to approximately 10 on abdomen and arm. No further information is available.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: No adverse event
Clinical narrative: Information has been received from a registered nurse concerning an approximately 23 month old female patient with hypoplastic left heart syndrome and no drug reactions/allergies who on 08-JUN-2011 was vaccinated with the first dose of ROTATEQ orally (dose unknown, lot # not reported). Concomitant therapy included aspirin, digoxin, LASIX, captopril and ranitidine. "Now" the patient had a gastrostomy tube. The nurse did not have any information on the reason the patient needed a gastrostomy tube at this time. It was unknown if the patient sought medical attention. The outcome of "had a gastrostomy tube" was unknown at the time of the report. Follow-up information has been received from the registered nurse concerning the patient who was vaccinated with the first dose of ROTATEQ (lot # 669832/0259AA) and concomitantly received the first dose of PENTACEL, ENGERIX-B and the first dose of PREVNAR 13, (Lot numbers not reported). The registered nurse did not know why the patient had the Gastrostomy tube inserted. The patient had a physician's visit on 19-SEP-2011. The patient was seen with the Gastrostomy tube in place. Follow-up information has been received from the registered nurse concerning that this patient did not have a "reverse reaction". She had a gastrostomy tube. So we contacted the company to see if we could administer it this way. We came to the decision not to give it per gastrostomy tube. She received a dose at an earlier age that had been p.o. but no problems arose with the dose. Additional information is not expected.
Age: 0.7
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning an anonymous of 8 to 8.5 months old patients who "sometimes in early 2009" was vaccinated with "one dose" of ROTATEQ after 8 months of age (Lot number not reported). No adverse effect reported. No expiration date or patient demographics provided. No further information is available.
Age: 0.34
Sex: M
Vaccine: RV5
Symptoms: Crying, Product taste abnormal, Retching, Screaming
Clinical narrative: Information has been received from a Licensed Practical Nurse (L.P.N.) concerning an 18 week old male patient with no pertinent medical history and drug reactions/allergy who on 19-AUG-2011 was orally vaccinated with a first dose of 2ml ROTATEQ and on 19-Oct-2011 was orally vaccinated with a second dose of 2ml ROTATEQ (lot# 669757/0884AA, exp: 14-OCT-2012). There was no concomitant medication. During administration of ROTATEQ on 19-OCT-2011, the patient "made a gaggy face" and started to gag, scream, and cry throughout the administration. Nurse reported that the patient did not vomit. Nurse suspected a quality issue with this dose of ROTATEQ. Nurse requested a lot check. No lab diagnostics study was performed and no treatment was given for the adverse events. At the time of report, the outcomes of the adverse events were unknown. Follow up information was received from the Licensed Practical Nurse (L.P.N.) concerning an 18 week old male patient with no pertinent medical history and drug reactions/allergy who at AM on 19-Oct-2011 was orally vaccinated with a second dose of ROTATEQ (lot# 669757/0884AA). Upon administration of ROTATEQ, the patient began to gag, scream and cry. The patient made a face like vaccine did not taste well. The patient had been recovered already on 19-OCT-2011. This is one of several reports received from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
Sex: U
Vaccine: RV5
Symptoms: Oral administration complication, Regurgitation
Clinical narrative: Information has been received from a healthcare student concerning a patient who on unspecified date was vaccinated with a dose of ROTATEQ (lot number, dose and site of administration not reported). On unspecified date, the patient regurgitated a dose of ROTATEQ after administration. It was unknown if the patient sought medical attention. At the time of the report, the patient's outcome was unknown. No further information is available.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a 21 week old male patient who on 01-SEP-2011 was vaccinated with his first dose of ROTATEQ (lot # not provided). No adverse experience had been reported. Whether the patient sought medical attention was not reported. Follow up information has been received from a physician concerning the patient with gastrooesophageal reflux disease (GERD) who at 12:00 pm on 01-SEP-2011 was vaccinated with the first dose of ROTATEQ (Lot number 669996/0326AA) and vaccinated IM with the first dose of PREVNAR 13 (Lot number: 037117) in left thigh, and the first dose of PENTACEL (Lot number: C3755AA) in right thigh. Concomitant therapy included PREVACID. The physician reported that no adverse event. The patient was fine before and after the vaccination. The physician also report that the patient was born weighted 9 pounds and 15.1 ounce. The patient had 2 siblings. Additional information is not expected.
Age: 64.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Infection, Injection site pain, Injection site swelling, Oedema peripheral
Clinical narrative: Case number PHHY2011US113884 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS: 434548) website on 30 Dec 2011 with the follow-up received from Quality assurance department (reference number: 140393) on 06 Jan 2012, with another follow-up from the quality assurance department (reference number: 140393) on 02 Apr 2012: This report refers to 64 year old patient of unknown gender. The patient was vaccinated with FLUVIRIN (batch number: 1100121) intramuscularly in the left arm on 12 Sep 2011 and pneumococcal polysaccharide vaccine (other manufacturer, batch number: 0595AA) intramuscularly in the left arm on 12 Sep 2011. On 13 Sep 2011, the patient experienced swelling of arm at the site of injection and was painful upon touch. The patient felt shortness of breath on 13 Sep 2011. The physician felt there is infection in the arm of patient. The patient still had pain and swelling in arm 5 days later. The physician prescribed a 5 day course of KEFLEX 500mg qid. The outcome of events was reported as complete recovery. Based on the document review, it was stated that the concerned FLUVIRIN batch number 1100121 was manufactured in accordance with approved internal procedures and were in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from Quality assurance department on 06 Jan 2012: Updated Quality complaint number (sentry record number: 140393). Follow-up received from the quality assurance department (reference number: 140393) on 02 Apr 2012: Updated batch review report.
Age: 64.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: Case number PHHY2011US113884 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS: 434548) website on 30 Dec 2011 with the follow-up received from Quality assurance department (reference number: 140393) on 06 Jan 2012, with another follow-up from the quality assurance department (reference number: 140393) on 02 Apr 2012: This report refers to 64 year old patient of unknown gender. The patient was vaccinated with FLUVIRIN (batch number: 1100121) intramuscularly in the left arm on 12 Sep 2011 and pneumococcal polysaccharide vaccine (other manufacturer, batch number: 0595AA) intramuscularly in the left arm on 12 Sep 2011. On 13 Sep 2011, the patient experienced swelling of arm at the site of injection and was painful upon touch. The patient felt shortness of breath on 13 Sep 2011. The physician felt there is infection in the arm of patient. The patient still had pain and swelling in arm 5 days later. The physician prescribed a 5 day course of KEFLEX 500mg qid. The outcome of events was reported as complete recovery. Based on the document review, it was stated that the concerned FLUVIRIN batch number 1100121 was manufactured in accordance with approved internal procedures and were in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from Quality assurance department on 06 Jan 2012: Updated Quality complaint number (sentry record number: 140393). Follow-up received from the quality assurance department (reference number: 140393) on 02 Apr 2012: Updated batch review report.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Bacterial infection, Injection site erythema, Injection site swelling, Injection site warmth, Oedema peripheral
Clinical narrative: Case number PHHY2011US113894 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 434822) website on 30 Dec 2011 with the follow-up received from Quality assurance department (reference number: 152860) on 02 Apr 2012: This report refers to a 68-year-old female patient. Her medical history included hypertension, heart murmur, V-tach (ventricular tachycardia) and treatment with Penicillin, Sulfa, ibuprofen and betablockers. Concomitant medications included lisinopril, CLEOCIN, KLOR-CON, LASIX, PREVACID, ZETIA, CENESTIN, diltiazem, CRESTOR, SYNTHROID and PROMETRIUM. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on to the left arm and pneumococcal polysaccharide vaccine (other manufacturer, batch no: not reported) intramuscularly on the left arm on 17 Sep 2011. It was reported that on the same day about two hours after injection, she experienced swelling, redness and increased temperature at the site of injection. Swelling progressed down and up her arm. Laboratory test diagnosed a bacterial infection. She made an emergency room visit. The outcome of events was reported as condition unchanged. Since the batch number was not reported, a batch specific review could not be performed. Based on the Annual Product Review (APR) of FLUVIRIN, it was concluded that FLUVIRIN manufacturing process was operated at a good level of overall control and the supporting systems are effective in supporting the compliant production, testing and supply processes for FLUVIRIN. From this conclusion there was no reason or explanation to account for the reported adverse event. Follow-up received from Quality assurance department on 02 Apr 2012: Updated batch review report.