chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Asthenia, Headache
Clinical narrative: Pt stated he had headache and felt weak. Pt lied down, vitals taken BP 118/67; retaken 129/80. Apple juice x2 given. Pt stated he longer had headache & was not weak.
Age: 12.0
Sex: F
Vaccine: FLUN3, MNQ, TDAP
Symptoms: Nuclear magnetic resonance imaging abnormal, Optic nerve disorder, Optic neuritis
Clinical narrative: Optic neuritis, possible transverse myelitis vs ADEM. Responded to steroids.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Skin warm
Clinical narrative: 3/25/11 2:30pm Cellulitis (centric) of 3-4 inches diameter. The area is warm to hot to touch; reddish in color.
Age: 51.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Chills, Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Low grade fever, chills, body aches began w/i 24 hrs. Body aches increased for 48 hrs. Injection site red and slightly swollen x 6 days.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Convulsion, Laboratory test normal
Clinical narrative: Patient suffered a seizure approximately one hour after immunizations were given. Patient was evaluated in emergency dept. and discharged after 5 hours of monitoring post seizure activity.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Bilirubinuria, Pyrexia
Clinical narrative: Had fever of 103 degrees F with bilirubinuria and acute elevated ALT/AST from 9 & 10 respectively to 96 & 45 then decreasing again after fever broke. No local site reaction noted.
Age: 26.0
Sex: F
Vaccine: IPV, RAB, TDAP, TYP
Symptoms: Hypoaesthesia
Clinical narrative: Numbness of 4th & 5th (L) fingers - "a few days after receiving injections" (vaccinations) (3/1/11).
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning patient who on 26-JUN-2009, 14-SEP-2009 and 04-FEB-2010 was vaccinated with the first, second and third dose of ROTATEQ respectively. The patient received the third dose of ROTATEQ after 32 weeks of age. At the time of the report, the patient was not experiencing any known symptoms. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 11-JAN-2010 and 04-FEB-2010 was vaccinated orally with doses of ROTATEQ (lot # not reported). No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a consumer concerning his 30 months old daughter with no pertinent medical history who received her ROTATEQ series at age 2 months, 4 months, and 6 months. There was no concomitant medication. "About 5 days ago", on approximately 30-JAN-2010 the patient had a case of diarrhea that resembled a rotavirus infection. She was not dehydrated and seemed "normal" except for the diarrhea. It had not been officially diagnosed as rotavirus but there were cases of rotavirus reported in the local area. Also the infection had not spread to her brothers. The patient did not seek medical attention. No diagnostic laboratory tests were performed. At the time of the report, the patient had not recovered. This is one of several reports received from the same source. No further information is available.
Sex: U
Vaccine: RV5
Symptoms: Rotavirus infection
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with ROTATEQ (lot# not reported). Subsequently the patient experienced with a mild to moderate case of rotavirus. It was unknown how many doses of ROTATEQ and when did the patient vaccinated. The patient sought medical attention via office. At the time of the report, the patient status was unknown. Additional information has been requested.
Age: 0.36
Sex: M
Vaccine: RV5
Symptoms: Oral administration complication, Regurgitation, Vomiting
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date received the second dose of ROTATEQ (dose and lot # not reported) through oral administration. On 11-FEB-2010, the patient received the third dose of ROTATEQ (dose and lot # not reported) through oral administration. The physician reported that the patient spit out or regurgitated his second and third dose of ROTATEQ. No adverse effect reported. Follow-up information was received from the physician concerning this 18 week old male with no medical history, concurrent condition or illness at the time of vaccination who on 04-NOV-2009 received the second dose of ROTATEQ (lot # not reported) and spit it out. On 11-FEB-2010, the patient received the third dose of ROTATEQ (lot # 664649/1083Y) and vomited a few seconds after taking the vaccine. Subsequently the patient recovered. No further information was not available.
Age: 0.4
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a 16 weeks old female patient who in December 2009 was vaccinated with a dose of ROTATEQ (route and lot # unknown) at 16 weeks of age. The physician stated the she was a "micro preemie" and she was not released from the hospital until 16 weeks. No adverse effects reported. The patient sought medical attention at the physician's office. This is one of several reports from the same source. Additional information has been requested. This is an amended report. The ONUM of multiple=2 was deleted. The report's reportability changed from do not send to periodic.
Age: 0.4
Sex: F
Vaccine: RV5
Symptoms: No adverse event
Clinical narrative: Information has been received from a physician concerning a 16 weeks old female patient who in December 2009, was vaccinated with a dose of ROTATEQ (route and lot # unknown) at 16 weeks of age. The physician stated the she was a "micro preemie" and she was not release from the hospital until 16 weeks. No adverse effects reported. The patient sought medical attention at the physician's office. This is one of several reports from the same source. Additional information has been requested. This is an amended report. The ONUM of multiple=2 was deleted. The reporter's reportability was changed from do not send to periodic.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Incorrect dose administered, Infantile spitting up, Oral administration complication, Retching, Vomiting
Clinical narrative: Information has been received from a medical assistant concerning a 9 weeks old female with no pertinent medical history and no known allergies who on 18-FEB-2010 was vaccinated with the first dose of ROTATEQ (lot number 664783/1211Y). The patient received 4 drops from the first tube and spit it up. The remainder of the dose was not given to the child. The medical assistant attempted to give another tube of vaccine and gave 2 drops when the patient spit it up. This second tube was not finished. Concomitant medications included 3 other unspecified vaccines on the same day. Medical attention was sought via office visit. There was no lab studies performed. On 18-FEB-2010, the patient recovered. Follow-up information received from the medical assistant concerning the 9 weeks old female patient with no pertinent medical history and no illness at time of vaccination who on 18-FEB-2010, at 11:00 AM was vaccinated orally with the first dose of ROTATEQ (lot number 664783/1211Y). The patient gagged and vomited when a few drops of the vaccine was administered orally; the patient vomited again when full dose administered. The patient was administered a second dose of vaccine because the medical assistant was not aware of not needing to re-administer dose. The patient then was given injectables for PENTACEL, RECOMBIVAX HB (manufacturer unspecified) and PREVNAR IM without incidence. The patient and her parents left the office after the injectables were given; the patient seemed okay. Additional information is not expected. This is an amended report. The AE term "inappropriate schedule of drug administration " has been removed from this case.
Age: 0.08
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 32 day old patient who on 11-DEC-2009 was vaccinated with the first dose of ROTATEQ at 4 weeks of age. On 12-JAN-2010 and 20-FEB-2010, the patient received the second and third dose of ROTATEQ, respectively. No adverse effect was reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 0.36
Sex: F
Vaccine: RV5
Symptoms: Culture urine, Full blood count abnormal, Laboratory test, Pyrexia, White blood cell count increased
Clinical narrative: Information has been received from a physician concerning a 16 week old female with no pertinent medical history, drug reactions or allergies who in December 2009, was vaccinated orally with the first dose of ROTATEQ (dose and lot number not reported). Subsequently, the patient was vaccinated orally with the second dose of ROTATEQ (Lot # 664882/1522Y). Concomitant medication included all routine vaccinations. On 23-FEB-2010 the patient experienced fever and abnormal white blood cell count showed by a CBC test that was performed. The physician reported that the patient came back in the office on 24-FEB-2009 for a follow up visit and the patient had recovered. Follow up information was received from a health professional concerning a 16 week old female with pertinent medical history, no know drug allergies and no illness at the time of vaccination who on 22-FEB-2010 was vaccinated orally with second dose (previously reported as first dose) of ROTATEQ (dose not reported, lot number 664882/1522Y). It was reported that on 23-FEB-2010, the patient developed fever and elevated white blood cell count. Laboratory tests performed included CBC, UIA and urine culture (results not provided). The patient recovered from fever and elevated white blood cell count on an unspecified date. No further information is available.
Age: 0.14
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Diarrhoea, Lethargy, Pallor, Unresponsive to stimuli, Vomiting
Clinical narrative: Information has been received from a physician concerning a 50 day old male patient with no medical history and no drug reactions or allergies who on 18-FEB-2010, was vaccinated with the first dose of "regular dose" of ROTATEQ orally (lot # 664876/1470Y). On the same day, the patient also received a dose of PENTACEL, PREVNAR and ENGERIX B (manufacturer unknown). On 18-FEB-2010 the patient experienced diarrhea, lethargy, vomiting green, pale and not responsive. The interval between the administration of ROTATEQ and the onset of symptoms was not provided. The patient went to emergency room. No lab diagnostics studies were performed. On 19-FEB-2010, the patient recovered. Follow up information was received from the physician which reported that the male patient on 18-FEB-2010, was vaccinated with the first PO dose of ROTATEQ orally (lot # 664876/1470Y). On the same day, the patient also received the first dose of PENTACEL (lot # C3497AA) in the right vastus lateralis, the first dose of PREVNAR (lot # E13862) into left vastus lateralis and the first dose of ENGERIX B (lot # AHBUB818AA) in left vastus lateralis. On 18-FEB-2010, the patient experienced severe vomiting and diarrhea. Subsequently the patient recovered. The patient did not seek medical attention. Additional information is not expected.
Age: 0.6
Sex: M
Vaccine: RV5
Symptoms: Rotavirus infection
Clinical narrative: Information has been received from a physician concerning a 7 month old male who on unspecified date was vaccinated with three doses of ROTATEQ oral (lot # not provided). The physician reported that the patient received all three doses and still got rotavirus. The physician also stated that the patient did not receive his first dose at the practice, so it was not sure if the patient received ROTATEQ or ROTARIX. The patient was not hospitalized because the patient's parents did not want him to be hospitalized, however the physician stated that he would have hospitalized him. On unspecified date, the patient recovered from rotavirus. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Regurgitation, Vaccine positive rechallenge, Vomiting
Clinical narrative: Information has been received from a physician concerning a female who on 23-DEC-2009 was vaccinated PO with the 2 ml first dose of ROTATEQ. On 03-MAR-2010 the patient was vaccinated PO with the second 2 ml dose of ROTATEQ (lot number___). The physician reported that the patient vomited up the first and second dose of vaccine. It was unknown if medical attention was sought. The outcome of the patient was not reported. Additional information has been requested.
Age: 0.22
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a Registered Nurse concerning a 12 week old female patient with no pertinent medical history and no known drug allergies, who on 06-JAN-2010 was vaccinated with a dose of ROTATEQ (lot number 664437/0536Y). There was no concomitant medication. On 13-JAN-2010 the patient experienced diarrhea for almost 3 weeks after administration. On 01-FEB-2010, the patient recovered. The patient sought medical attention (office visit). No laboratory diagnostics studies were performed. Follow up information has been received from a Registered Nurse who reported that the patient with no pre-existing allergies, birth defects, medical conditions or illness at the time of vaccination was vaccinated with the first oral dose of ROTATEQ (lot number 664437/0536Y) on 06-JAN-2010. It was stated that on 07-JAN-2010 (previously reported as 13-JAN-2010) the patient experienced profuse diarrhea for 3 weeks. At the time of the report the patient had recovered. No laboratory diagnostics studies were performed. No further information is available.
Sex: M
Vaccine: RV5
Symptoms: Rotavirus infection
Clinical narrative: Information has been received from a physician concerning a 20 month old male patient who on 28-AUG-2008 was vaccinated with a first 0.2 ml oral dose of ROTATEQ, a second 0.2 ml oral dose of ROTATEQ on 27-OCT-2008 and a third 0.2 ml oral dose of ROTATEQ on 02-JAN-2009. It was reported that the patient developed rotavirus after all three doses of ROTATEQ. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Rotavirus infection
Clinical narrative: Information has been received from a physician concerning a 23 month old female patient who on 06-JUN-2008 was vaccinated orally with the first 0.2 ml dose of ROTATEQ. On 01-AUG-2008 and 13-OCT-2008, the patient was vaccinated with the second and third dose of ROTATEQ respectively. It was reported that the patient developed rotavirus after all three doses of ROTATEQ. At the time of the report the patient had improved. The patient sought unspecified medical attention. Additional information has been requested.
Age: 0.02
Sex: M
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a physician concerning a 6 day old male patient who on an unspecified date was vaccinated with a dose of ROTATEQ. No adverse effect was reported. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Regurgitation, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a male baby who on 24-MAR-2010 was vaccinated orally with his third dose of ROTATEQ. At the time of vaccination, the baby vomited up his third dose of ROTATEQ. No adverse effect was reported. It was unknown if the patient sought medical attention. At the time of the report, the baby's outcome was unknown. Follow-up information has been received from the registered nurse concerning a six months old male baby with no illness at the time of vaccination who was vaccinated orally with his third dose of ROTATEQ (lot # 664874/1213Y) at approximately 16:15 on 24-MAR-2010. At the time of the report, the baby's status was unknown. Additional information has been requested.
Age: 0.19
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 10 weeks patient who on 04-MAR-2010 was vaccinated with the first dose of ROTATEQ and on 26-MAR-2010 was vaccinated with the second dose of ROTATEQ. No adverse effect was reported. It was not specified if the patient sought medical attention. Additional information has been requested.
Age: 1.02
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 12 months old patient who on 29-MAR-2010 was vaccinated with the third dose of ROTATEQ by accident. The reporting physician did not have the dates of the first and second doses of ROTATEQ. The patient was not experiencing any known symptoms. It was not specified if the patient sought medical attention. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Regurgitation
Clinical narrative: Information has been received from a Certified Medical Assistant concerning a 2 month old female infant who on 30-MAR-2010 was vaccinated orally with a dose of ROTATEQ. Concomitant therapy included a dose of PREVNAR, a dose of PEDIARIX and a dose of Hib (unspecified carrier). Within a minute of receive ROTATEQ the patient "threw up the medicine". The patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a nurse concerning a 4 month old patient who on an unspecified date was vaccinated with the second dose of ROTATEQ (lot number not reported). The infant vomited a few minutes after vaccination. The patient also received other routine unnamed vaccinations. Unspecified medical attention was sought. The outcome of the patient was not reported. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: RV5
Symptoms: Choking, Cough
Clinical narrative: Information has been received from a consumer concerning her 17 weeks old son with no previous medical history and no known allergies who on 21-JAN-2010 was vaccinated PO with the first 2 ml dose of ROTATEQ (lot number not reported). On 25-MAR-2010, the patient was vaccinated PO with the second 2 ml dose of ROTATEQ (lot number 665022/1613Y). Concomitant therapy included hepatitis B vaccine (manufacturer unspecified), PREVNAR and PENTACEL (unspecified). The patient choked a little bit on ROTATEQ after in was given which cause coughing. The patient has had no further adverse reaction from the vaccine. There was no lab study performed. On 25-MAR-2010, the patient had recovered. Follow-up information received from a registered nurse concerning the 17 weeks old male patient with no illness at time of vaccination who on 25-MAR-2010 at 13:58 PM was vaccinated PO with the second dose of ROTATEQ (lot number 665022/1613Y). The baby was administered the vaccine by the registered nurse. On 25-MAR-2010, at 14:00 PM, the baby apparently choked on vaccine. The registered nurse did not feel it was necessary to document event or get physician to assess the child. The mother stated she was concerned that the baby possibly aspirated 'live vaccine", so she called the Company. The patient recovered on 25-MAR-2010. There was no adverse reaction reported after the patient left the office. Additional information is not expected.
Age: 0.58
Sex: F
Vaccine: RV5
Symptoms: Rotavirus infection, Rotavirus test positive
Clinical narrative: Information has been received from a nurse concerning a 22 month old female patient who was vaccinated orally with three doses of ROTATEQ (lot#s follow as 660682/0574X, 660880/0923X, 662618/0925X) respectively on 04-AUG-2008, 06-OCT-2008 and 03-DEC-2008. On an unspecified date in the week of 29-MAR-2010, the patient was tested positive for rotavirus after being fully vaccinated with ROTATEQ. The patient was brought to the doctor's office and was treated with diet and fluids. At the time of this report, the patient was recovering. This is one of several reports from the same source. This is a consolidation of two reports concerning the same patient. Additional information has been requested.
Age: 0.57
Sex: M
Vaccine: RV5
Symptoms: Rotavirus test positive
Clinical narrative: Information has been received from a nurse concerning a 16 month old male patient who on 12-FEB-2009 was vaccinated with the first dose of ROTATEQ (lot # 662825/1168X). On 15-APR-2009 the patient was vaccinated with the second dose of ROTATEQ (lot # 663396/1724X). On 15-JUN-2009 the patient was vaccinated with the third dose of ROTATEQ (lot # 663842/0068Y). On 29-MAR-2010 the patient tested positive for rotavirus after being fully vaccinated with ROTATEQ. The patient went to doctor's office for medical attention. The patient was treated with diet and fluids and was improving. This is one of several reports from the same source. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Regurgitation
Clinical narrative: Information has been received from a bachelor of science in nursing concerning an eight weeks female baby, who on an unknown date was vaccinated with the first dose of ROTATEQ, oral. The bachelor of science in nursing reported that the patient regurgitated the ROTATEQ. The patient was drinking a bottle of formula at the time. A portion of ROTATEQ was administered first and then the patient regurgitated about a half a cup. Then after the patient continued to drink from the bottle, a portion of the ROTATEQ was regurgitated a second time. At the time of the report, the patient recovered. No laboratory diagnostic study was performed. The patient did not seek medical attention. Additional information has been requested.
Age: 0.38
Sex: F
Vaccine: DTAPIPVHIB, PPV, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning an 18 weeks male patient who on an unspecified date was vaccinated with the first dose of ROTATEQ. No adverse effect was reported. It was unspecified if the patient sought medical attention. Follow up information has been received from the physician's office manager who indicated that the patient was an 18 weeks female patient (previously reported as male) who on 11-FEB-2010 was vaccinated with the first dose of ROTATEQ. Concomitant vaccinations included the second dose of PENTACEL and the second dose of pneumococcal conj vaccine (unspecified). The office manager stated that they did not provide ROTATEQ to the patient. The patient's first visit to the reporting physician's office was for her six month well check on 09-APR-2010. The office manager confirmed that according to the patient's mom, there were no adverse events. It was also reported that ROTATEQ was administered at a public health clinic/hospital. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient who on 14-SEP-2009, 30-DEC-2009 and 12-APR-2010 was vaccinated with the first, second and third doses of ROTATEQ respectively. No adverse effect was reported. It was not specified if the patient sought medical attention. Additional information has been requested.
Age: 0.9
Sex: U
Vaccine: RV5
Symptoms: No adverse event
Clinical narrative: Information has been received from a registered nurse concerning an 11 month old patient who on 13-APR-2010 was vaccinated with the second dose of ROTATEQ (lot number not reported). There was no adverse effect reported. It was unknown if medical attention was sought. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Gastroenteritis, Hypersensitivity
Clinical narrative: Information has been received from a physician concerning a 16 week old patient who in May 2010, was vaccinated with a dose of ROTATEQ (Lot#: not reported). The physician reported a scheduled visit to examine an infant who, after receiving ROTATEQ, had a severe case of gastroenteritis. He was unsure if it was a severe allergic reaction. He said he thought that an adverse experience report was filled by the pediatrician who administered the vaccine. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. Follow up information has been received from the physician indicated that he didn't want to received any further follow up mailings because he didn't know anything regarding the patient. No further information is available.
Age: 0.35
Sex: M
Vaccine: RV5
Symptoms: No adverse event
Clinical narrative: Information has been received from a registered nurse concerning an 18 week old male patient with a history of premature birth at 28 weeks who on 17-MAY-2010 was vaccinated with a dose of ROTATEQ; he did not receive the first dose while in the hospital. On 21-JUL-2010 the patient was vaccinated with a second dose of ROTATEQ. No adverse symptoms were noted. Additional information has been requested.
Age: 0.8
Sex: U
Vaccine: RV5
Symptoms: No adverse event
Clinical narrative: Information has been received from a physician concerning a 9 month old patient who on an unspecified date was vaccinated with a dose of ROTATEQ (Lot # not reported). No adverse experience was reported. It was not specified if the patient sought medical attention. This is one of two reports received from the same source. The health care professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination, dose, lot number. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 20 weeks and 5 days old patient who on 23-JUL-2010 was vaccinated orally with the first 2ml dose of ROTATEQ (lot # reported as 1507Y). The physician stated that she thought the patient already had the first dose of ROTATEQ so she administered a dose today (23-JUL-2010). After giving the dose to the patient, she realized the patient that was 20 weeks and 5 days old and never received the first dose. The patient was fine at this time. No medical attention was sought. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Accidental exposure, Eye irritation, Vision blurred
Clinical narrative: Information has been received from a female medical assistant concerning herself who on an unspecified date was given an oral dose of ROTATEQ (Lot # unknown) to a baby. The medical assistant stated that the baby coughed and spitted out the vaccine into her eye. Her eyes were burning and blurry. She did flush her eyes with water and they were not as burning but still blurry. At the time of the report, the patient had not recovered. It was unknown if the patient sought medical attention. This is one of several reports from the same source. No further information is available.
Sex: U
Vaccine: RV5
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a consumer concerning her child who on 03-AUG-2010 was vaccinated with a dose of ROTATEQ Lot# unknown). The reporter stated that on 03-AUG-2010, she took her child to her pediatrician's office for a check up. She stated that a nurse came in and gave her child a dose of ROTATEQ, however this shot was intended for the patient next door and not her child. She also reported that her child had already received the full course of ROTATEQ and this would had been an extra dose. No further information is available.
Age: 0.15
Sex: M
Vaccine: RV5
Symptoms: Lip discolouration, Oral mucosal discolouration
Clinical narrative: Information has been received from a physician concerning a 2 months old male patient who on 01-AUG-2010 ("5 days ago") was vaccinated orally with the first dose of ROTATEQ (lot# not reported). On 01-AUG-2010 the patient developed a discoloration at the corners of his mouth, and the discoloration had worsened since the ROTATEQ was administered. Unspecified medical attention was sought. The patient's a discoloration at the corners of his mouth persisted. Follow up information has been received from a physician concerning the male patient with a family history of eczema who on 28-JUL-2010 was vaccinated orally with the first dose of ROTATEQ (lot# 668123/0512Z). There was no illness at time of vaccination. On 29-JUL-2010, the patient developed discoloration (darkening) of his mouth. There were no laboratory diagnostics studies performed. At the time of this report, the patient's outcome was unknown. Follow up information has been received from a physician concerning the male patient who on 28-JUL-2010 was vaccinated orally with the first dose of ROTATEQ. On 29-JUL-2010, the patient developed discoloration of his lips. At the time of this report, the patient had recovered. Additional information is not expected.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Decreased appetite, Dehydration, Diarrhoea, Irritability, Urine output decreased
Clinical narrative: Information has been received from a consumer concerning a 17 week old female with no pertinent medical history reported and no known drug allergies/reactions who on 12-APR-2010 was vaccinated with a dose of ROTATEQ (dose, route and lot number not reported). There was no concomitant medication. Within 12 hours after receiving ROTATEQ, on approximately 12-APR-2010 the patient experienced severe diarrhea, dehydration, reduced urine output, loss of appetite, vomiting and irritability. The patient's mother states that she "took her daughter to the emergency room on Sunday 18-APR-2010, but she was not admitted". Laboratory tests performed included stool studies (results not provided). The patient's mother also stated that her daughter received ROTARIX as her first vaccination against rotavirus gastroenteritis on 02-MAR-2010 and did not experience any adverse effects after receiving that. Therapy with ROTATEQ was discontinued. The patient's severe diarrhea and dehydration and reduced urine output and loss of appetite and vomiting and irritability persisted. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a consumer concerning a 17 week old female with no pertinent medical history reported and no known drug allergies/reactions who on 12-APR-2010 was vaccinated with a dose of ROTATEQ (dose, route and lot number not reported). There was no concomitant medication. Within 12 hours after receiving ROTATEQ, on approximately 12-APR-2010 the patient experienced severe diarrhea, dehydration, reduced urine output, loss of appetite, vomiting and irritability. The patient's mother states that she "took her daughter to the emergency room on Sunday 18-APR-2010, but she was not admitted". Laboratory tests performed included stool studies (results not provided). The patient's mother also stated that her daughter received ROTARIX as her first vaccination against rotavirus gastroenteritis on 02-MAR-2010 and did not experience any adverse effects after receiving that. Therapy with ROTATEQ was discontinued. The patient's severe diarrhea and dehydration and reduced urine output and loss of appetite and vomiting and irritability persisted. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: No adverse event
Clinical narrative: Information has been received from a Certified Medical Assistant concerning a male patient who received his first dose of ROTATEQ (oral route, lot # unknown) at 15 weeks and 6 days old. No adverse effects reported. No further information is available.
Age: 0.8
Sex: U
Vaccine: RV5
Symptoms: No adverse event
Clinical narrative: Information has been received from a physician concerning a 9 month old patient who on an unspecified date was vaccinated with a dose of ROTATEQ (Lot # not reported). No adverse experience was reported. It was not specified if the patient sought medical attention. The health professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination, dose, lot number. This is one of two reports received from the same source. Additional information has been requested.
Age: 0.07
Sex: M
Vaccine: RV5
Symptoms: No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 26 day old male patient who was orally vaccinated with the first, second and third dose of ROTATEQ on 12-NOV-2009, 16-DEC-2009 and 12-FEB-2010, respectively. The patient sought medical attention by an office visit. There were no adverse effects reported. Additional information has been requested.
Age: 0.21
Sex: F
Vaccine: RV5
Symptoms: Haematemesis, Haemoglobin, Occult blood
Clinical narrative: Information has been received from a nurse practitioner concerning an 11 week old female patient with no pertinent medical history, drug reactions/allergies, who on 13-APR-2010 was vaccinated orally with the first dose of ROTATEQ (Lot No. 664945/0147Z), 3 days later (on 16-APR-2010) the patient had small vomiting along with blood that occurred twice on the same day. The patient sought medical attention at office visit. The patient had hemoglobin and guaic (hemoccult) laboratories performed (results not reported). On 23-APR-2010, the patient recovered. Follow up information has been received which reported that an 11 week old female patient with no pre-existing allergies, birth defects or medical conditions, who on 13-APR-2010 at 14:40, was vaccinated orally with the first dose of ROTATEQ (Lot No. 664945/0147Z). There was no illness at the time of vaccination. It was reported that 3 days after the vaccine was ingested the patient vomited blood twice (reported as on 23-APR-2010, also reported as on 16-APR-2010 by the nurse practitioner), at 14:00. The outcome of the patient was recovered soon after the doctor visit. Additional information is not expected.
Age: 0.16
Sex: U
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Diarrhoea, Faeces discoloured, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 60 day old patient who on 28-JUL-2010 was orally vaccinated with a dose of ROTATEQ. Concomitant therapy included PENTACEL, "PCV-13" and hepatitis B vaccine, recomb (manufacturer unknown). On 04-AUG-2010, the patient's mother called in to report that on 28-JUL-2010 the patient had had a low grade fever and watery pee colored stool. The physician recommended that the patient drank PEDIALYTE SOLUTION and ate yogurt. At the time of the report, the child was still recovering. Additional information has been requested.
Age: 0.63
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a health professional concerning a 7 month old patient who on 05-NOV-2009 was vaccinated oral with the first 2 ml dose of ROTATEQ. On 21-APR-2010 the patient received their last dose of ROTATEQ, at greater than 32 weeks of age. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 1.4
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a 17 month old female patient who on an unspecified date was vaccinated orally with the second 2 ml dose of ROTATEQ (Lot # not reported) outside of the recommended timeframe in the prescribing information. No adverse effect was reported. It was not specified if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a healthcare working concerning a patient who on 01-MAR-2010 was vaccinated with the first dose of ROTATEQ (therapy dose, route and site unknown). The healthcare working reported that the patient received the vaccine later than recommended; the patient received ROTATEQ on 01-MAR-2010, 14-JUL-2010 and 17-AUG-2010 and no adverse effect. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a 17 week old patient who was vaccinated with the first dose of ROTATEQ orally on an unspecified date. No adverse symptoms were reported. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a 16 week old patient who on 07-MAY-2010 was vaccinated with the first dose of ROTATEQ orally. No adverse symptoms were reported. Additional information has been requested.
Age: 0.27
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Erythema, Hypersomnia, Swelling face
Clinical narrative: Information has been received from a nurse concerning a 14 weeks old female who on 01-JUN-2010 and 27-JUL-2010 was vaccinated with the first and second dose of ROTATEQ respectively. (Lot number is 665276/0302z for the first dose and 668041/0510z for the second dose). Concomitant therapy included PENTACEL and PREVNAR. On 28-JUL-2010, the patient experienced facial swelling after receiving her second dose of ROTATEQ on 27-JUL-2010. Her right cheek was swollen and bright red. She did not have a fever but experienced an increase in sleep. The patient was seen in the office on 28-JUL-2010 and 30-JUL-2010. By 30-JUL-2010, her face had improved. On unknown date, the patient recovered. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Immediate post-injection reaction, Vomiting
Clinical narrative: Information has been received from a physician concerning a patient who was orally vaccinated with a dose of ROTATEQ on an unspecified date. The patient vomited immediately after administration. It was unknown which dose in the series. The patient visit the office and was orally administered another dose of ROTATEQ. On unspecified date, the patient recovered. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from an immunization field consultant concerning an approximately 62 day old (also reported as 2 months old) patient who on an unspecified date was vaccinated with the first dose of ROTATEQ (lot # not reported). After receiving the vaccination the patient had developed diarrhea for 2 weeks. On an unspecified date the patient recovered on therapy. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a nurse practitioner concerning a 6 month old female patient with no known allergies who on 01-JUN-2010, was vaccinated with the first one tube dose of ROTATEQ (oral vaccine). There was no concomitant medication. Her relevant past drug history included she was behind on her immunizations and she had very poor immunization records. On 01-JUN-2010, the child received what was thought to be the second dose of ROTATEQ. On 01-JUN-2010, upon later review of the child's immunization records it was discovered that she had never started the ROTATEQ series, so the child actually received a first dose of ROTATEQ series at 6 months old. No relevant laboratory testing was done. As of 01-JUN-2010, it was unknown if the child would receive the remaining doses of ROTATEQ series, and her status was unknown. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Stool analysis
Clinical narrative: Information has been received from a consumer concerning her approximately 16 month old son with chronic constipation before receiving ROTATEQ and with no drug allergies who on an unspecified date was vaccinated with ROTATEQ (lot # not reported). There was no concomitant therapy. After the vaccination her son had been experiencing diarrhea. The patient went to emergency room but not admitted. Stool sample was collected for test no result provided. He still had diarrhea occasionally. At the time of the report, the outcome of the event was unknown. The consumer also mentioned that her son "always got sick after receiving vaccines". In the past, the patient developed a fever and seizure while on prior therapy with hepatitis B virus vaccine (WAES# 1006USA00380). No further information is available.
Age: 0.34
Sex: U
Vaccine: RV5
Symptoms: No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 16 weeks patient who was vaccinated, oral, with ROTATEQ on 15-JUN-2010, 19-AUG-2010, and 23-AUG-2010. No adverse effect was reported. The lot number of third dose was 663908/0176Y, the other lot numbers were no known. The patient sought unspecified medical attention. Additional information has been requested.
Age: 0.34
Sex: U
Vaccine: RV5
Symptoms: No adverse event
Clinical narrative: Information has been received from a physician concerning a 4 month old patient who on 05-APR-2010 was vaccinated with the first dose of ROTATEQ at 4 month of age. No adverse effect reported. Additional information has been requested.
Sex: M
Vaccine: RV5
Symptoms: Mucous stools
Clinical narrative: Information has been received from a registered nurse concerning a male child who on 28-APR-2010 was vaccinated with a dose of ROTATEQ. On 01-MAY-2010 the patient's mother called the office stating that her child had very mucousy stools. It was reported that the patient's mother was breast feeding and there had been some dietary changes to dairy free. On 01-MAY-2010 the patient was placed on a soy formula but mucousy stools continued. At the time of the report, the patient was on "ALIMENTUM" formula and had not recovered. Additional information has been requested.
Age: 0.81
Sex: M
Vaccine: RV5
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a physician concerning a 9 month old male who in October 2009, was vaccinated with a first dose of ROTATEQ (oral, lot # 664345/1056Y), the second dose (oral, lot # 664592/1057Y) in January 2010 and the third dose (oral, lot # 665273/0204Z) on 09-JUN-2010. No adverse effects were reported. Follow up information received from physician concerning a 9 month old male with no illness at time of vaccination, who on 09-JUN-2010 at a.m. was vaccinated with a third dose of ROTATEQ (oral, lot # 665273/0204Z). It was reported that the wrong dose was administered in spite of the patient being 9 months already. Previous dose was administered 5 months earlier. The patient did not have an adverse effect, and there was no adverse effects following prior vaccination. No further information is available.
Age: 0.19
Sex: F
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 10 week old female who on 04-JUN-2010 was vaccinated with the first 2ml dose of ROTATEQ (oral, lot # 664876/1470Y). On 05-JUN-2010 at 2:00 am the patient was vomiting. The patient was treated with PEDIALYTE SOLUTION and then clear fluids for 6-8 hours. Symptoms subsided in a a few hours. The patient received unspecified medical attention. On an unspecified date, the patient recovered from vomiting. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Rotavirus infection, Rotavirus test positive
Clinical narrative: Information has been received from a nurse practitioner concerning an approximately 9 week old female patient with history of being premature baby and pneumonia and others unspecified who on approximately February 2009 (at 2 months) was vaccinated orally with her first 0.2 ml dose of ROTATEQ. In approximately February 2009 (a week later) the patient came down with the rotavirus. The patient sought unknown medical attention. Lab diagnostic tests were performed: unspecified which ones. The patient recovered on an unspecified date. The patient still finished the series and was fine after the rest of the doses of ROTATEQ. No further information provided. Follow up information has been received from a physician concerning the 9 week old female patient with prematuration and no illness at time of vaccination who on 02-DEC-2008 was vaccination orally with the first dose of ROTATEQ (Lot # 663234/1473X). The patient's sibling developed diarrhea at 7 years old without vaccination. On 06-DEC-2008 the patient developed diarrhea. Stool sample was sent for rotavirus ova and parasite examination on 09-DEC-2008 and antigen was positive on 10-DEC-2008. The final report verified at 10:55 on 10-DEC-2008 was antigen detected. The patient recovered on 08-DEC-2008. Additional information is not expected.
Age: 0.08
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a 30 day old female patient who on 21-MAY-2010 was vaccinated with a dose of ROTATEQ (Lot number 665272/0203Z). The physician stated that the infant received the first dose of ROTATEQ suspension too soon (on 21-MAY-2010). No adverse symptoms noted. The patient sought unspecified medical attention. Additional information has been requested.
Age: 0.1
Sex: U
Vaccine: RV5
Symptoms: No adverse event
Clinical narrative: Information has been received from a physician concerning a 32 day old patient who on unspecified date was vaccinated with the first dose of ROTATEQ. No adverse effect reported. Additional information has been requested.
Age: 0.1
Sex: U
Vaccine: DTP, PPV, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a Registered Nurse (R.N) concerning a patient who approximately 31 day old on an unknown date, was vaccinated with ROTATEQ and PNEUMOVAX at one month of age at another physician's office. Concomitant therapy included DTP. No adverse effect reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 0.9
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning an 11 month old patient who on 30-AUG-2010 receive the third 2ml dose of ROTATEQ, oral. It was unspecified if the patient sought medical attention. No adverse effect was reported. Additional information has been requested.
Age: 0.36
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a Healthcare Worker concerning a approximately 20 week old patient who in June 2010, was vaccinated with the first dose of ROTATEQ (lot number is 665259/0202z). No adverse effect reported. The patient did not seek medical attention. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Oral administration complication, Vomiting
Clinical narrative: Information has been received from a physician concerning a 9 week-old female with acid reflux who on 30-AUG-2010 was vaccinated with ROTATEQ PO. The physician reported that the patient was given ROTATEQ and immediately vomited. The AE improved after stopping therapy. The patient recovered on 30-AUG-2010. The patient sought unspecified medical attention. Additional information has been requested.