chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 6 month old patient (weight 20 pounds 10 ounces) with no illness at time of vaccination or pre-existing allergies, birth defects, medical conditions who on 04-DEC-2008 was vaccinated with the first dose of ROTATEQ (lot # 662876/1169X) oral administration. Concomitant therapy included DAPTACEL (Lot # C3082AA) and ACTHIB (lot # UF579AA). On 06-DEC-2008 the patient experienced severe diarrhea, 5 times a day. Subsequently, 24 hours after the patient recovered. On 04-FEB-2009 the patient received her second dose of ROTATEQ (lot # 662953/1169X), and her second dose of DAPTACEL and ACTHIB. On 06-FEB-2009 the patient experienced severe diarrhea, 5 times a day. Subsequently, 24 hours after the patient recovered. Additional information is not expected.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a 11 month old male who on 20-FEB-2008 and 19-NOV-2008 when the patient was 11 months of age was vaccinated with the first and third dose of ROTATEQ (lot number not reported) oral respectively.  No adverse symptoms reported.  Additional information has been requested.
Age: 0.25
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Reflux oesophagitis
Clinical narrative: Information has been received from a consumer concerning her daughter who was vaccinated with four different vaccines at 3 months of age, in approximately Jan 2008, is including a dose of ROTATEQ (manufacturer unspecified).  It was reported that after the vaccination the patient experienced diarrhea for 3 to 4 weeks and was only able to eat hypo-allergenic formula.  Later she developed reflux which the reporter considered to be not related to formula.  The patient was now 1 and a half year old and had to take PREVACID every morning.  At time of reporting the patient's outcome was unknown.  Additional information is not expected.
Age: 0.3
Sex: F
Vaccine: RV5
Symptoms: Immediate post-injection reaction, Rash
Clinical narrative: Information has been received from a physician concerning a 12 week old female infant who was vaccinated with the first dose of ROTATEQ. The patient developed rash immediately after administration. Additional information has been requested.
Age: 0.23
Sex: M
Vaccine: RV5
Symptoms: Culture stool negative, Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 12 weeks old male patient who was born pre-term at 34 weeks and on 31-MAR-2009 was vaccinated orally with the first dose of ROTATEQ.  Since 05-APR-2009 the patient has been experiencing six watery stools per day.  A stool culture was performed.  Results were not reported.  The patient was seen at the practice.  The physician reported that the patient's sibling also received ROTATEQ and was experiencing the same adverse event (WAES # 0904USA03411).  Follow-up information was received from a nurse who reported that both patients received ROTATEQ vaccine (lot # 663400/1693X).  It was reported that they have not yet received the patient's stool culture results.  The nurse did not know the patient's current status.  Follow up information received on 28-MAY-2009 from a physician stated that the patient experienced diarrhea for 2 weeks and the stool culture done to rule out bacteria as the cause of diarrhea was negative.  The patient recovered approximately on 24-APR-2009.  This is one of two reports from the same source.  No further information is available.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Gastroenteritis rotavirus
Clinical narrative: Information has been received from a nurse concerning a patient who was vaccinated with ROTATEQ.  On 22-APR-2009 the patient was diagnosed with rotavirus.  The patient was not hospitalized.  At the time of reporting, the outcome was unknown.  It is unknown if the patient sought medical attention.  This is one of several reports from the same source.  Follow up information was received from a physician concerning the 12 month old patient who on 10-JUN-2008, 11-AUG-2008 and 09-OCT-2008 was vaccinated with the first, second and third dose of ROTATEQ (lot # 660286/183OU, 660289/1888U and 660548/0501X) respectively.  Additional information has been requested.
Age: 0.24
Sex: U
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Accidental exposure
Clinical narrative: Information has been received from a nurse practitioner concerning a 11 week old patient who on 28-DEC-2008 was vaccinated with the first dose of hepatitis B virus vaccine.  On 16-MAR-2009, the patient was vaccinated with a dose of ROTATEQ and the second dose of hepatitis B virus vaccine (MSD, WAES # 0904USA01908).  Vaccine received at the same day including, PREVNAR, IPOL, ACTHIB and TRIPEDIA.  On 26-MAR-2009 the patient was again inadvertently vaccinated with a dose of ROTATEQ and the third dose of hepatitis B virus vaccine.  Vaccine received at the same day including PREVNAR, IPOL, ACTHIB and TRIPEDIA.  No symptoms reported.  Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a medical assistant concerning a 17 weeks old male patient with no pertinent medical history and no known allergies who on 02-FEB-2009 was vaccinated orally with the first dose of ROTATEQ (lot # 660550/0616X) and on 17-APR-2009 received orally the second dose of ROTATEQ (LOT # 663142/1462X).  There was no concomitant medication.  On 17-APR-2009, 5 to 10 minutes after receiving his second dose of ROTATEQ, the patient vomited.  It was reported that the patient was seen for an office visit.  On 17-APR-2009 the patient recovered.  Follow-up information has been received from a physician concerning the infant patient.  It was reported that on 17-APR-2009 the patient concomitantly received a dose of PENTACEL and a dose of PREVNAR.  There was no illness present at the time of vaccination.  It was reported that the patient promptly vomited ROTATEQ after it was given.  The physician office contacted a company representative to see if the patient should be given another dose of ROTATEQ and she told them not to.  There were no problems the patient experienced after this event.  No laboratory or diagnostic tests were performed.  On 15-JUN-2009 the patient received the third dose of ROTATEQ without problem.  No further information is available.
Age: 0.2
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a registered nurse concerning an approximately 8 week old patient with no pertinent medical history and no known drug allergies/reactions who on 13-APR-2009 was vaccinated with the first PO standard dose of ROTATEQ.  Concomitant therapy included PEDIARIX, ACTHIB and PREVNAR.  On approximately 14-APR-2009 ("24 to 48 hours after the vaccination") the patient experienced diarrhea.  No lab diagnostics studies were performed.  At the time of reporting, the patient's diarrhea persisted.  The patient sought medical attention via seeing the physician assistant.  Further information has been requested.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 8 week old patient, with no pertinent medical history, who on an unspecified date, was vaccinated with the first dose of ROTATEQ, orally.  Concomitantly, the patient also received other "normal" 2 month old vaccinations.  The physician reported that the patient experienced explosive, frequent and odorous diarrhea after receiving the vaccination.  At the time of the report, the patient had recovered.  Follow-up information has been received from the physician via telephone call indicating the patient's name, date of birth and vaccine's lot number (Lot # 661032/0469X).  The physician reported that the patient developed diarrhea one week after receiving the ROTATEQ.  The physician stated that the patient had recovered.  Additional information is not expected.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a Registered Nurse concerning a 15 week old patient who on 01-MAY-2009 was orally vaccinated with the first dose of ROTATEQ, "1 tube", at an age later than recommended. The child was not experiencing any known symptoms. Additional information has been requested.
Age: 0.51
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 23 month old male who on 27-JUN-2007 was vaccinated with a first dose of ROTATEQ.  On 27-AUG-2007 the patient received a third dose of ROTATEQ (lot # 657668/1390U).  On 21-APR-2009 the patient developed vomiting that lasted 24 hours, followed by watery diarrhea that lasted for 4 days, the patient also experienced fever.  The patient had recovered.  Follow up information has been received from the registered nurse concerning a male patient, who on 21-APR-2009 experienced vomiting for 24 hours, then he had watery diarrhea that lasted for 4 days, the patient also had fever.  Subsequently, the patient fully recovered.  The patient's sister also had an adverse event after vaccination with ROTATEQ (WAES # 0905USA00018).  This is one of two reports from the same source.  No further information is available.
Age: 0.52
Sex: M
Vaccine: RV5
Symptoms: Clostridium test negative, Gastroenteritis rotavirus, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with three doses of ROTATEQ. Subsequently the patient developed rotavirus. At the time of reporting, the outcome was unknown. It is unknown if the patient sought medical attention. Follow-up information has been received from a registered nurse concerning the 20 months old male patient who was vaccinated with all 3 doses of ROTATEQ on 20-AUG-2007, 19-OCT-2007 and 27-DEC-2007 respectively. Lot numbers reported as 657514/0667U and 657520/0670U (dose numbers unspecified). On 25-FEB-2009 the patient developed diarrhea rotavirus. On 27-FEB-2009, the patient tested positive for rotavirus. On 03-MAR-2009, the patient was positive for rotavirus. The physician spoke with the patient's mother and it was reported that the patient was doing well and the diarrhea had improved. The patient had good oral intake. On an unspecified date, the patient recovered. Additional information is not expected.
Age: 0.42
Sex: F
Vaccine: RV5
Symptoms: Gastroenteritis rotavirus, Respiratory syncytial virus infection, Respiratory syncytial virus test positive, Rotavirus test positive
Clinical narrative: Information has been received from a registered nurse concerning an approximately 24 month old female who in December 2007, was vaccinated with the first dose of ROTATEQ and in March 2008, was vaccinated with the second dose. On 11-MAR-2009 the patient was tested positive for rotavirus and respiratory syncytial virus (RSV) at the same time. It was reported that the patient recovered both from rotavirus and respiratory syncytial virus (RSV) (date unspecified). The patient sought unspecified medical attention from a nurse. Follow-up information was received from a health professional concerning this 29 month old female patient (also reported as approximately 24 month) who on 27-DEC-2006, was vaccinated PO with the first dose of ROTATEQ (lot #: 655405/1113F) and on 09-MAR-2007, was vaccinated PO with the second dose (lot #: 656106/1233F). On 11-MAR-2009 the patient was tested positive for rotavirus. Additional information has been requested. This is one of several reports from the same source.
Age: 0.23
Sex: M
Vaccine: RV5
Symptoms: Culture stool negative, Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 12 weeks old male patient, born at 34 weeks gestation who on 31-MAR-2009 was vaccinated orally with the first dose of ROTATEQ. Since 05-APR-2009 the patient has been experiencing six watery stools per day. A stool culture was performed. Results were not reported. The patient was seen at the practice. The physician reported that the patient's sibling also received ROTATEQ vaccine and was experiencing the same adverse event (WAES # 0904USA03555). Follow-up information was received from a nurse who reported that both patients received ROTATEQ vaccine (lot # 663400/1693X). The patient's stool culture was negative. The nurse did not know the patient's current status. Follow-up information has been received from the physician concerning this 12 weeks old male patient, born at 34 weeks gestation who on 31-MAR-2009 was vaccinated orally with a dose of ROTATEQ (lot # 663400/1693X). There was no illness at the time of vaccination. The physician reported that since 05-APR-2009, the patient had diarrhea for 2 weeks. The patient had a stool culture performed to rule out bacteria as the cause of the diarrhea. The culture was negative. Subsequently, the patient recovered on approximately 24-APR-2009. Additional information is not expected.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Weight increased
Clinical narrative: Information has been received from a physician concerning a 4 month old male patient who was vaccinated with his first dose of ROTATEQ orally. After receiving the vaccine the patient experienced severe diarrhea that lasted for thirty days. The patient had seen physician for medical attention. The physician reported that the patient's weight was back up and on an unspecified date the patient had recovered. Follow up information was received from the physician concerning the patient who was vaccinated with the first dose of ROTATEQ on 18-MAR-2009. On 19-MAR-2009, 1 day after vaccination, the patient developed severe, persistent diarrhea. The patient experienced 6 watery stools per day. The patient responded to cereal added to diet and the diarrhea resolved in 30 days, on approximately 18-APR-2009. The patient was able to gain weight in spite of the diarrhea. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Rotavirus infection, Rotavirus test positive
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with ROTATEQ. Subsequently the patient was tested positive for rotavirus. The reporter could not find the chart at the time of reporting, so she was not sure whether there was an AE involved with the patient. This is one of several reports from the same source. Additional information has been requested.
Age: 0.74
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a medical assistant concerning an 8 month old male who on 20-APR-2009 was vaccinated orally with first dose of ROTATEQ (lot number reported as "657360/0508U").  No adverse symptoms reported.  It was not specified if the patient sought medical attention.  Additional information has been requested.
Age: 0.38
Sex: F
Vaccine: RV5
Symptoms: Clostridium test positive, Diarrhoea, Faeces discoloured, Rotavirus infection, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning an approximately 11 week old female who on 31-OCT-2008 was vaccinated orally with the second dose 2 ml dose of ROTATEQ. "After receiving her second dose", the patient experienced "red and watery stools" and the patient did test positive for rotavirus. On 15-JAN-2009 the series of ROTATEQ were decided to discontinue. The patient recovered on an unspecified date. Unspecified medical attention was sought. Follow-up information was received from the physician concerning the 8 month old patient with no illness at time of vaccination, no pre-existing allergies or birth defects or medical conditions. On 31-OCT-2008 the patient was vaccinated orally with the first dose of ROTATEQ (lot # 660880/0923X). Concomitantly, the patient was vaccinated IM with the second dose of PANTACEL (lot # C3176AA) on the same day. On 15-JAN-2009 the patient was vaccinated orally with the second dose of ROTATEQ (lot # 662876/1169X). The physician reported that the patient got only 2 doses of ROTATEQ. She developed diarrhea at 8 month of age. On 27-APR-2009 the sample of the patient's stools was collected for rotavirus antigen test. The following lab tests for stools were also ordered: routine ova and parasites exam, C. Difficile toxins A and B test, white blood cells, direct giardia lamblia, stool culture. On 06-MAY-2009 the patient's mother was notified and diarrhea was improving. The results on 08-MAY-2009 revealed that rotavirus antigen test was positive (also reported as on 05-MAY-2009 the rotavirus antigen test was positive) and the stool C. Difficile toxins A and B test was abnormal. The other lab test results were not provided. The physician also reported that the patient's rotavirus antigen test was positive at the age of 8 month, the time of the "third" dose of ROTATEQ. The patient was recovered on 09-MAY-2009. Additional information is not expected.
Age: 28.0
Sex: F
Vaccine: RV5
Symptoms: Lacrimation increased
Clinical narrative: Information has been received from a registered nurse concerning a 28 year old female certified medical assistant (CMA) who on 21-APR-2009 had ROTATEQ spit in her eye by a child who received the vaccine (WAES #0904USA03828).  The CMA's eye teared up and was watering.  The eye was flushed with water and the CMA was advised to see an eye doctor for follow-up.  It was reported that the CMA was not wearing contact lens.  This is one of two reports received from the same source.  Additional information has been requested.
Age: 0.53
Sex: F
Vaccine: RV5
Symptoms: Rotavirus infection, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning a 17 month old female patient who was administered orally with the first, second, third dose of ROTATEQ on 14-JAN-2008, 24-MAR-2008 and 27-MAR-2008.  On 03-May-2009 the patient presented with Rota virus symptoms and was taken to the emergency room.  It was not sure if the patient was admitted.  The patient sought unspecified medical attention.  On an unspecified date the patient recovered.  Additional information has been received from a physician concerning a patient who on 14-JAN-2008, 24-MAR-2008, and 27-MAY-2008 (previously reported as 27-MAR-2008) was vaccinated with the first, second and third dose of ROTATEQ separately.  It was reported that the child did get vaccine on appropriate schedule, but she did get rotavirus infection (confirmed by lab) also in 1 year after the last dose (on 03-MAY-2009).  Rotavirus antigen was detected on 03-MAY-2009.  No further information is available.
Age: 0.55
Sex: F
Vaccine: RV5
Symptoms: Infantile spitting up, Vomiting
Clinical narrative: Information has been received from a medical assistant concerning a 6 month old female patient with no pertinent medical history and no drug reactions/allergies who in December 2008, was vaccinated with the first 2 ml oral dose of ROTATEQ (lot # not reported) and on 21-APR-2009 received her third 2 ml oral dose of ROTATEQ (#663460/1792X). On 21-APR-2009 the patient spit up the vaccine after the full dose was administered. No other adverse effects were reported. Follow-up information was received from the medical assistant who reported that on 21-APR-2009, the patient received the third dose of ROTATEQ (lot # 663460/1792X) P.O at 15:00 hours. The medical assistant reported that the patient spit up after the third dose was given. No further information is available.
Age: 0.7
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a licensed practical nurse concerning a 37 week old female who was vaccinated with a first dose of ROTATEQ (lot # not reported) on 20-NOV-2008 and 07-MAY-2009, respectively. It was reported that the patient received her second dose when she was 37 weeks old. No adverse effect reported. Additional information has been requested.
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a male who on 22-APR-2009 was vaccinated orally with the first dose of ROTATEQ.  On 12-MAY-2009 the patient was vaccinated orally with the second 2 ml dose of ROTATEQ.  The patient had not experienced any known symptoms.  It was unknown if the patient sought medical attention or not.  Additional information has been requested.
Age: 1.19
Sex: F
Vaccine: RV5
Symptoms: Rotavirus infection, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning a 14 month old female patient with cardiac disorder who on 07-APR-2009 was vaccinated with a first dose of ROTATEQ (Lot # not reported) 2ml, orally.  On 14-APR-2009 the patient experienced rotavirus.  The patient sought unspecified medical attention.  Test for Rotavirus was performed.  Additional information has been requested.
Age: 0.19
Sex: F
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a medical assistant concerning a 9 week old female with no pertinent medical history and no known drug allergies who on 13-MAY-2009 was vaccinated orally with a dose of ROTATEQ (lot # 663461/0285Y).  There was no concomitant medication.  On the same day, after receiving ROTATEQ, the patient vomited 5 minutes.  No lab tests were done.  The patient recovered on the same day.  Unspecified medical attention was sought.  Follow-up information was received from the medical assistant which reported that the white baby had no illness at time of vaccination.  On 13-MAY-2009 the baby was in the office for well baby exam and was vaccinated orally with the first dose of ROTATEQ (lot # 663461/0285Y).  No further information was provided at this time.  Additional information is not expected.
Age: 0.44
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Incorrect storage of drug
Clinical narrative: Information has been received from a nurse concerning a 23 week old patient who on 22-Jun-2009 was vaccinated orally with a dose of ROTAVIRUS (Lot # 663679/1765X) that was improperly stored as low as 31 degrees F on one occasion in the month of June 2009. No adverse effects were reported. Follow-up information was received from the licensed practical nurse concerning the 6 months female who on 22-Jun-2009 was vaccinated with the second dose of ROTAVIRUS (Lot # 663679/1765X thimersol free) at the private doctor's office / hospital. Secondary suspect therapy included the second dose of RECOMBIVAX (Lot # 662113/0293Y). Concomitant therapy included the second dose of PREVNAR (Lot # 034438), the second dose of PENTACEL (Lot # C3282AA). This is one of tow reports from the same source. No further information is available.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Anxiety disorder, Arthralgia, Asthenia, Colitis ulcerative
Clinical narrative: Information has been received from a lawyer regarding a case in litigation, which was reported in March 2009 concerning a 32 year old female patient who on three unspecified dates in 1993 was vaccinated with a dose of RECOMBIVAX HB. Subsequently the patient experienced ulcerative colitis, stomach pain, joint pain, fatigue, weakness, weight loss, clinical depression and anxiety disorder. The reporter felt that ulcerative colitis, stomach pain, joint pain, fatigue, weakness, weight loss, clinical depression and anxiety disorder were not related to therapy with RECOMBIVAX. No further information is available.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Depression, Fatigue, Weight decreased
Clinical narrative: Information has been received from a lawyer regarding a case in litigation, which was reported in March 2009 concerning a 32 year old female patient who on three unspecified dates in 1993 was vaccinated with a dose of RECOMBIVAX HB. Subsequently the patient experienced ulcerative colitis, stomach pain, joint pain, fatigue, weakness, weight loss, clinical depression and anxiety disorder. The reporter felt that ulcerative colitis, stomach pain, joint pain, fatigue, weakness, weight loss, clinical depression and anxiety disorder were not related to therapy with RECOMBIVAX. No further information is available.
Age: 33.0
Sex: U
Vaccine: HEP
Symptoms: Erythema nodosum, Neuropathy peripheral
Clinical narrative: Information has been received from a lawyer regarding a case in litigation, which was reported in a Litigation report, concerning a 33 year old patient who in 1992 was vaccinated with two RECOMBIVAX HB.  Subsequently, the patient experienced chronic erythema nodosum, peripheral neuropathy and other symptoms.  The government agreed to $50,000 in compensation.  The outcome was unknown.  No further information is available.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Vaccination failure
Clinical narrative: Information has been received from a physician's assistant concerning a 32 year old female patient with an allergy to penicillin who was vaccinated with four 1 ml doses of RECOMBIVAX HB (lot # not reported), respectively. The first and second doses were received on 24-JUL-2007 and 28-AUG-2007, respectively. The dates of the third and fourth dose were not reported. The patient had a negative Hepatitis B titer after receiving the initial three doses regimen (considered a vaccination failure). It was noted that the patient received the fourth dose but still responded with a negative titer. The patient had not experienced any known symptoms. The patient sought medical attention at the practice. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Combined immunodeficiency, Diarrhoea, Rotavirus test positive
Clinical narrative: Information has been received from a health professional, concerning a child patient who was vaccinated with ROTATEQ and developed diarrhea for an unspecified period of time (presumably for about a month).  The child was diagnosed with severe combined immunodeficiency (SCID).  Molecular analyses performed on the virus recovered from the stool revealed the presence of the W179-9 reassortant, referred as to G1 for simplicity, from ROTATEQ.  Test revealed that several gene products (NSP1, VP6, and NSP4) shared almost 100% nucleotide identity with the corresponding gene products of WC3 (the backbone of ROTATEQ), conforming the presence of vaccine virus.  In addition, the VP7 of the virus was shown to be 100% identical to that of W179, which makes up the VP7 protein of the G1 reassortant.  In addition, VP4 analyses revealed the presence of a wildtype human VP4 of serotype / genotype P1A(8) - suggesting that the G1 reassortant of the vaccine reassorted with a wildtype human rotavirus possessing a P1A (8) VP4.  Note that the VP4 from the virus in the stool was not a match to that of the W179-4 reassortant, also known as P1.  This is one of the reports received from the same source.  No further information is expected.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from a nurse practitioner (N.P.) concerning a 12 year old female patient with no relevant medical history or drug allergy who in 1997 was vaccinated with a dose of RECOMBIVAX HB (lot # not reported). There is no concomitant medication. It was reported that the patient developed benign lymphadenopathy 12 years ago (in 1997) after receiving the vaccine. The patient sought medical attention at the physician's office. On an unspecified date, the patient recovered from the benign lymphadenopathy. Additional information has been requested.
Age: 0.66
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a nurse concerning an approximately 8 week old female who on approximately 11-MAY-2009, "within the last week", was vaccinated orally with the first 2 ml dose of ROTATEQ.  On approximately 11-MAY-2009, "after receiving her first dose", the patient experienced mild vomiting and diarrhea.  The outcome was not reported.  Unspecified medical attention was sought.  No further information is available.
Age: 0.51
Sex: F
Vaccine: RV5
Symptoms: No reaction on previous exposure to drug, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning a 6 month old female with no medical history or drugs allergies, who on 16-JAN-2009 was vaccinated with the first dose of ROTATEQ.  The patient received a second dose of ROTATEQ on 20-MAR-2009 and a third dose of ROTATEQ (lot # 663841/0083Y) on 22-MAY-2009, oral.  There was no concomitant medication.  The patient vomited the third dose.  The patient had no problems with dose 1 and 2.  No laboratories studies performed.  The patient sought medical attention through an office visit.  The patient recovered on 22-MAY-2009.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Visual impairment
Clinical narrative: Information has been received from a female consumer who was vaccinated with a dose of RECOMBIVAX HB (manufacturer unspecified) when she was around 21 years of age. Subsequently the patient experienced vision problem on an unspecified date. No other details provided. This is one of several reports received form same source. Additional information has been requested.
Age: 0.7
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning an 8 month and 19 days old patient who was vaccinated PO with the third 2 ml dose of ROTATEQ vaccine. No adverse effect reported. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Culture stool positive, Salmonellosis
Clinical narrative: Information has been received from an office manager at the physician's office concerning a 6 month old male patient who was vaccinated PO with a dose of ROTATEQ. Subsequently the patient had stool specimen done and it came back positive for salmonella. At the time of reporting, the outcome was unknown. It is unknown if the patient sought medical attention. It was also reported that the patient's twin experienced adverse event on ROTATEQ (WAES #0906USA00842). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Injection site induration
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who on approximately 21-APR-2009, "last week," was vaccinated with the third dose of RECOMBIVAX HB (lot number, site and route not reported). The patient's injection site developed into a dense hardness area. According to the patient, some of the vaccine might have been leaked out from the site. The outcome of the event was not reported. No further information is available.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Eczema
Clinical narrative: Information has been received from medical records concerning a 22 week old female who on 17-DEC-2008 was administered the first dose of oral ROTATEQ vaccine 0.5 mL (lot #662652/1272X). Concomitant therapy included PEDIARIX 0.5 mL IM in right thigh, (lot #AC21B198BA). ACTHIB 0.5 mL in left thigh (lot #UF513AB) and PREVENAR 0.5 mL IM in left thigh (lot #C99098). On 16-Feb-2009 the patient saw the physician for a well child visit, and was vaccinated with a second dose of oral ROTATEQ. On 16-DEC-2008 she also was vaccinated with PEDIARIX 0.5 mL IM in left deltoid, (lot #AC21B1201AA), ACTHIB 0.5 mL in right deltoid (lot #UF531AA) and PREVENAR 0.5 mL IM in left deltoid. The mother was advised about growth and the baby was scheduled for another well child care visit in 2 months. On 24-MAR-2009 the baby, now 5 months old was taken to see the physician for a rash. The mother noted that the rash started about a week ago and seemed to come and go. It was mostly on her face and abdomen. Otherwise the baby was doing well with no fever, and interacting normally on physical exam the baby's skin had generalized erythematous rash, most notable on scalp. Impression by the physician was rash and other non specific skin eruption. It was prickly heat rash vs. cradle cap vs viral exanthem. The physical exam was appropriate. The mother was given instructions to keep the baby cool and exfoliate her scalp gently. She was to return to clinic if any changes. On 16-APR-2009, the baby was seen in an office visit for follow up of the rash (viral exanthem, vs prickly heat rash). The rash was now worse and was all over the body, more at skin folds such as inner elbow and thighs. It was on her face as well. Mother had been using cetaphil soap which seemed to show slight improvement, then worsened. The mother reported that the baby continuously acted normally with normal feeding, bowel movements and activity. She denied any fever. The baby however was scratching all over a lot and sometimes pulling at left ear. At the visit the baby weighed 15 lbs. Temperature was 98.6 degrees C. On examination the baby's skin had generalized eczematous rash, worse at skin folds. No vesicles were seen. She had patchy distribution of maculopapular finely scaling rash. The physician's impression was dermatitis, atopic. The rash was spreading and looked like atopic picture, despite lack of family history of the triad. The mother was encouraged to use Dove soap, cetaphil or eucerin creams. Encouraged to use vaseline on face and diaper area and for rest of body area. Over the counter cortaid creams could be used. Ear pulling was probably either random movements or baby may be teething soon. She was to return to clinic in 2-3 weeks for follow up and 6 months well child care. The mother was instructed that the baby probably had eczema and to continue with the cares as instructed. Additional information is not expected. Medical records will be provided upon request.
Sex: U
Vaccine: RV5
Symptoms: Infantile spitting up
Clinical narrative: Information has been received from a certified medical assistant concerning a patient who was vaccinated with a dose of ROTATEQ. The medical assistant reported the patient "spit up a dose of ROTATEQ". Additional information has been requested.
Age: 0.8
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a 9 month old infant who was vaccinated with the third dose of ROTATEQ (lot number, route and site not reported). No adverse effect was reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Culture stool positive, Salmonellosis
Clinical narrative: Information has been received from an office manager at the physician's office concerning a 6 month old male patient who was vaccinated PO with a dose of ROTATEQ. Subsequently the patient had stool specimen done and it came back positive for salmonella. At the time of reporting, the outcome was unknown. It is unknown if the patient sought medical attention. It was also reported that the patient's twin experienced adverse event on ROTATEQ (WAES #0906USA00566). Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a certified medical assistant concerning a 61 day old female with no pertinent medical history reported and no known drug allergies who on 04-Jun-2009 was vaccinated orally with her first dose of ROTAVIRUS (lot number 662738/1358X). There was no concomitant medication. The certified medical assistant reported that on 04-Jun-2009, the patient vomited after receiving the dose of ROTAVIRUS. The patient recovered form the event on the same day. No lab tests were performed. The patient sought medical attention in the office. This is one of two reports from the same source. Additional information has been requested.
Age: 0.73
Sex: F
Vaccine: RV5
Symptoms: Allergy to arthropod bite, Cellulitis, Roseola
Clinical narrative: Information has been received from a certified medical assistant concerning an over 8 month female who on 06-APR-2009 was vaccinated with the initial dose of ROTATEQ (lot number and route not reported). Since vaccination, the patient developed roseola on 28-APR-2009, and on 19-MAY-2009 experienced cellulitis due to insect bites. The patient had sought medical attention at the office. The patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Malaise, Nausea, Vomiting
Clinical narrative: Information has been received from a registered pharmacist concerning a female facility employee with no medical history or drugs allergies, who on 06-Apr-2009 was vaccinated with a first doe of RECOMBIVAX (lot # 663280/1677X), intramuscularly. There was no concomitant medication. On 06-Apr-2009 and within 45 minutes the patient became "violently ill" with nausea and vomiting for 3-4 hours. The pharmacist was asking for a lot check. It was also reported that the employees health nurse will not continue to use this particular lot until it has been verified that there is no problems with this lot. No laboratories studies performed. The patient recovered on 06-Apr-2009. The patient did not seek medical attention. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation had Research and was released. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Accidental exposure, Pruritus
Clinical narrative: Information has been received from a medical assistant who on 18-JUN-2009 got "some" ROTATEQ (Lot # 663147/1486X) on both of her hands. It was noted that she washed her hands right away. The medical assistant stated she opened the foil pouch and as she was removing the oral dosing tube it felt wet and sticky. She then realized that the inside of the pouch was wet and concluded that the tube had leaked into the package. She stated that the end of the foil pouch was not sealed. It did not look like the foil was cut or as if someone opened it; it just looked as if it had not been sealed. There was no damage noted to the tube or cap or the foil other than the open end. It was reported that this had never happened before to this office. The medical assistant also reported that her hands have felt itchy since she was exposed to ROTATEQ. The medical assistant did not think it was related to the exposure but she thought she would mention it. At the time of the report, the patient's status was unknown. Follow-up information received from a physician indicated that the vaccine was already opened and was leaking when removed from paper box. It was not administered by them to patient. The medical assistant had not sought medical attention. There were no adverse effects reported. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Rotavirus infection
Clinical narrative: Information has been received from a physician concerning a "child" who on an unspecified date was vaccinated with a dose of ROTATEQ (lot number not reported). On an unspecified date after the vaccination, "the entire family was infected with Rotavirus". It was unknown whether medical attention was sought. At the time of the report, the outcome of the patient was not reported. This is one of several reports from the same source. No further information is available.
Age: 5.0
Sex: U
Vaccine: RV5
Symptoms: No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a 5 year old patient who on 19-JUN-2009 was vaccinated with a dose of ROTATEQ (PO).  At the time of the report, no adverse effect was reported.  Additional information has been requested.
Age: 0.19
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a nurse concerning a 10 week old male patient who on 03-Aug-2009 was vaccinated with a dose of ROTATEQ (lot number 663903/0088Y). On 04-Aug-2009 the patient developed diarrhea. It was noted that the patient has had 1-2 episodes of diarrhea since the vaccine was given. Medical attention was sought via an office visit with the physician. It was unspecified if lab studies were performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a pharmacist concerning a female patient with yeast allergy, who on an unspecified date was vaccinated with RECOMBIVAX HB (manufacturer unknown). The pharmacist reported that the patient had a severe reaction after receiving the vaccine. On an unspecified date, the patient recovered. The patient sought unspecified medical attention.
Age: 0.4
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse concerning an approximately 20 weeks old male patient who was vaccinated with the third dose of ROTATEQ (lot # not provided) orally a week after receiving the second dose of ROTATEQ. No adverse event reported.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 6 month old patient (unknown gender) who in approximately May 2009 at 12 week old, was vaccinated with the first dose of ROTATEQ (lot number and route not reported). On 13-AUG-2009 the patient was at the office to receive the second dose of ROTATEQ (lot number and route not reported). No adverse reactions reported. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Rotavirus infection, Rotavirus test positive
Clinical narrative: Information has been received from a Licensed Practical Nurse (L.P.N) concerning a "7 month old" male patient who "when was 2 months old" was vaccinated with the first 2 mL dose of ROTATEQ (Lot # 662951/1432X) by oral route.  It was reported that he received the second 2 mL dose of ROTATEQ at four months of age.  It was reported by the patient's parents that "3 weeks prior to 18-MAY-2009" (approximately on 27-APR-2009), the patient had been having symptoms of rotavirus.  The vaccine was not reintroduced.  The patient sought medical attention with a visit to the physician's office on 18-MAY-2009.  A rotavirus test was performed, and the patient was diagnosed positive for rotavirus.  It was reported that on an unspecified date the patient had recovered.  Additional information has been requested.
Age: 0.46
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 6 month old patient who on 17-AUG-2009 was vaccinated with the first and only dose of ROTATEQ.  It was reported that the patient received the vaccine later than the recommended age.  No adverse effect reported.  Follow up information was received from a physician concerning a 28.5 week old (previously) reported as 6 month old ) male infant who in August 2009 was vaccinated with a dose of ROTATEQ (Lot # 660269/0148X), valid for measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD).  It was reported that the patient received oral vaccine at 6 month check up under the assumption that he had received the 2 and 4 month doses at his previous physician's office.  It was reported that when immunization records were received, there was no 2 or 4 month doses given.  At the time of the report the patient was 2 weeks post-administration of ROTATEQ and has had no adverse reactions.  No further information is available.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Rotavirus infection, Rotavirus test positive, Vomiting
Clinical narrative: Information has been received from a physician concerning a 3 month old patient who "1 week ago", on 19-JUN-2009 was vaccinated with a dose of ROTATEQ. It was reported that, on approximately 26-JUN-2009, the patient experienced vomiting and diarrhea. The patient also had a positive rotavirus stool antigen test. It is unknown if the patient sought medical attention. At the time of reporting the patient had not recovered. Additional information has been requested.
Age: 0.26
Sex: M
Vaccine: RV5
Symptoms: Body temperature increased, Decreased appetite, Infantile spitting up, Irritability, Vomiting projectile
Clinical narrative: Information has been received from a registered nurse concerning a 13 week male with gastrooesophageal reflux disease and no known drug allergies, who on 10-Jun-2009 was vaccinated with the first and only dose of ROTATEQ (Lot: 661581/1461X). Concomitant therapy included REGLAN and PREVACID. On 11-Jun-2009 (reported as 24 hours after vaccination) the patient initially did not want to eat, and then started to vomit once or twice a day for 2 weeks. Sometimes the patient had projective vomiting. Subsequently, the patient recovered from the symptoms. Follow-up information was received on 17-Jul=2009 which reported that the 13 week old white male patient, on 11-Jun-2009 started out with extreme irritability along with this within 24 hrs, did not want to drink. Child typically ate 6 times a day and 3 of these times very irritable and would take a long time to finish bottle, spit up small amounts daily for 2 weeks at least one a day and projective vomiting for 1 week. He went from extreme irritable to being totally fine, low grade temperature from 01-Jun-2009 until 15-Jun-2009. Mother gave TYLENOL every Q4H, no diarrhea or loose stools, continued nutritional supplements (ISOMIL) formula. No dehydration, increased GERD meds approximately 2 weeks did not help. On 24-Jul-2009, the registered nurse reported that on 10-Jul-2009, the patient received her second dose of ROTATEQ. She said within the following 24 hours after vaccination, the child was slightly irritable lasting 5 days and had a low grade temperature for 1 day. Child did not get vomiting or diarrhea. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Infantile spitting up
Clinical narrative: Information has been received from a nurse concerning a "baby" patient who on 18-AUG-2009 spit up when was vaccinated orally with a dose of ROTATEQ (lot number not reported). At the time of the report, the outcome of the patient was not reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Dermatitis diaper, Diarrhoea
Clinical narrative: Information has been received from a patient's mother concerning her 18 week old female child with no pertinent medical history and no known drug allergies/drug reactions who on 16-JUN-2009 was vaccinated with the first 2 mL dose of ROTATEQ by oral route. On 10-AUG-2009, the patient received the second 2 mL dose of ROTATEQ (Lot # 663399/0308Y) by oral route. Concomitant vaccines included PEDIARIX, ACTHIB and PREVNAR. It was reported that mom called the doctor office on 14-AUG-2009 stating child had diarrhea and diaper rash. It was reported that the child was seen at the office on 18-AUG-2009; still had diarrhea and diaper rash. There were no laboratory diagnostic tests performed. It was reported that NYSTATIN was treatment for the diaper rash. It was reported that child still had watery stools and had not recovered at the time of the report. Follow up information was received from a physician concerning a 4 months old female patient who on 10-AUG-2009, in the morning, was vaccinated with the second dose of ROTATEQ (Lot # 663399/0308Y) by oral route. Concomitant vaccines given intramuscularly into her thigh on the same day included the second dose of PEDIARIX (Lot # AC21B187AA), ACTHIB (Lot # UF604AB) and PREVNAR (Lot # D75884). There were no illnesses at time of vaccination. It was reported that the infant had persistent loose stools from the day following her vaccine on, and it was reported that it lasted 2 weeks more. On 25-AUG-2009, the patient recovered. No further information is available.