chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.8
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a 9 month old male who on 18-MAY-2010 was inadvertently administered with the first dose of ROTATEQ. No adverse symptoms reported. It is unknown if the patient sought medical attention. No further information is available.
Sex: U
Vaccine: RV5
Symptoms: Infantile spitting up, No adverse event, Oral administration complication
Clinical narrative: Information has been received from a health care worker concerning a patient who on 07-SEP-2010 was vaccinated orally with a dose of ROTATEQ (dose and lot number not reported). On 07-SEP-2010 the patient "spit up/out", the ROTATEQ dose within 5 minutes of receiving it. At the time of the report the outcome of the patient was unknown. "No known adverse effect". Additional information has been requested.
Age: 0.37
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a consumer who reported that in approximately July 2010, her approximately 20 week old ("five months of age") daughter was vaccinated with the first dose of ROTATEQ (Lot # not reported) at five months of age, instead of 6-12 weeks as stated in the PI. Consumer was unwilling to give physician information. No adverse effect was reported. It was unspecified it the patient sought medical attention. No further information is available.
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a 20 week year old patient who on 10-SEP-2010 was vaccinated with a dose of ROTATEQ (Route and lot # no reported). No adverse effects reported. Additional information has been requested.
Age: 0.08
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a 4 weeks old patient who on 21-MAY-2010 was vaccinated PO with a first dose of ROTATEQ (Lot number not provided). The physician reported that the patient was vaccinated with ROTATEQ at 4 weeks of age which was two weeks earlier than what is suggested by the prescribing information. No adverse event reported. The patient received unspecified medical attention. Additional information has been requested.
Age: 0.19
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a registered nurse and a physician concerning an approximately 9 week old male patient who on 17-JUN-2010 (also reported as 16-JUN-2010), was vaccinated with the first PO dose of ROTATEQ. On 23-JUN-2010, the patient was inadvertently received a second partial dose of ROTATEQ. The partial dose consisted of 2 drops of ROTATEQ. No vomiting, diarrhea, or fever noted. No adverse symptoms were reported. The patient did not seek medical attention. Follow up information was received from the registered nurse and the doctor of osteopathy. The registered nurse reported that on 23-JUN-2010 at 13:00, the patient received the second PO dose of ROTATEQ (lot # 665343/1507Y). Full dose was not given. No side effect was noticed. It reported that the patient was recovered on 23-JUN-2010. Additional information is not expected.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Oral administration complication, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning a 60 day old male patient who on 23-JUN-2010 was vaccinated orally with a dose of ROTATEQ (lot# not reported). On 23-JUN-2010, immediately after administration, the patient vomited and he may have received an incomplete dose of ROTATEQ. At the time of this report, the patient had fully recovered. Additional information has been requested.
Age: 0.91
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 11 month old male patient who on 22-JUN-2010 was inadvertently vaccinated orally with a dose of ROTATEQ (lot# not reported). No adverse symptoms were reported. Follow-up information has been received from the RN concerning a 10 month old male with no illness, pre-existing allergies or medical conditions who on 22-JUN-2010 at 13:15 was vaccinated with the first dose of ROTATEQ (lot# 665254/0200Z) orally. Concomitant vaccination at the same time included RECOMBIVAX HB (lot# 665619/1021Y, Thimerosal free) (vaccination site: left leg), PENTACEL (vaccination site: left leg) (lot# C3299AA) and PREVNAR 13 (vaccination site: right leg) (lot# E47474). No adverse event reported. Additional information is not expected.
Age: 0.64
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 33 week and 5 days old patient who on 16-APR-2010 was vaccinated with the third dose of ROTATEQ (oral, 2 ml single unit dose) at the age of 33 weeks and five days. No adverse effects were reported. 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 physician concerning a patient who on an unspecified date was orally vaccinated with a dose of ROTATEQ. The physician reported that the ROTATEQ was administered off label by giving it later than 32 weeks. There was no adverse event reported. It was noted that this was brought up because the vaccine was not covered by insurance since it was given off label. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a consumer concerning a 12 month old male patient with "no known allergies" who on an unspecified dates was vaccinated with a first and second dose of ROTATEQ (dates, routes and lot numbers unspecified). It was reported that the baby patient began experiencing diarrhea and fever after each dose was given. The "Third dose was not given". The patient sought unspecified medical attention. At the time of the report the outcome of the patient was recovering. Additional information is not expected.
Age: 0.09
Sex: M
Vaccine: HEP, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a 31 day old male patient (4.5 weeks of age also reported as 2 day of age), who on 12-JUL-2010 was inadvertently given the first dose of ROTATEQ (lot number: 668123/0512Z, orally at 4.5 weeks of age instead of 6 weeks (lot number: 668123/0512Z). Concomitant therapy included RECOMBIVAX HB (manufacturer unspecified). No adverse effects were reported. The patient did not seek medical attention. Follow up information has been received from the physician who reported that 31 day old male patient who on 12-JUL-2010 at 15:00 p.m., was vaccinated IM with a second dose of RECOMBIVAX HB in the left thigh (lot number: 663280/1677X). The physician reported that no adverse events noted, just given the vaccine earlier that recommended age. Additional information is not expected.
Age: 0.01
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a 3 day old male patient, who on 15-JUL-2010 was inadvertently given a dose of ROTATEQ (dose and lot number not reported). No adverse effects reported. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product contamination physical, Product deposit
Clinical narrative: Information has been received from a nurse concerning a patient who on 22-SEP-2010 was vaccinated orally with ROTATEQ (lot # 667863/0685Z). While administering the ROTATEQ to the patient, the patient's mother noticed sediment and a small black object in the vial. The patient received some of this dose but was also administered a second 2 mL dose of ROTATEQ afterwards. No adverse reactions reported. Follow-up information has received from a nurse who reported that one of her staff was in the middle of administering the product when the infant's mother saw a black particle in the tube. They stopped administering the product and looked closer. The black particle was smaller than a grain of rice and oblong in shape. It was not flaky. The product also had three flaky white particles. One was round and another was the size of the grain rice. The product was shaken prior to given it. The office provided another half of dose to the infant. Follow-up information has been received from a physician concerning the patient, a 2 month old (approximately 8 week old) female child. The patient was "well check" and had GERD (Gastrooesophageal reflux disease) at time of vaccination. Nurse began to administer ROTATEQ and mother noticed something black floating in the vaccine. Nurse removed it from the patient's mouth and reported this to supervisor. There was a black contaminant about the size of a grain of rice and several other small white pieces of sediment/trash. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologic Evaluation and Research and was released. No further information is available.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Decreased eye contact, Lethargy, Mood altered
Clinical narrative: Information has been received from patient's mother who reported that her 6 month old male son with no medical history/allergies or drug reactions on approximately 27-FEB-2010 at 2 months old was vaccinated with a first dose of ROTATEQ. On 03-JUN-2010 the patient received a second dose of ROTATEQ. There was no concomitant medication. On 03-JUN-2010 after receiving the second dose the patient began to experience poor eye contact, decrease in laughter and lethargy. It was reported that the symptoms had improved but that the patient was "still not himself". The patient sought unspecified medical attention. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event
Clinical narrative: Information has been received from a physician concerning a 6 month old preterm infant who on 28-SEP-2010 was vaccinated with the first dose of ROTATEQ. No adverse effect reported. Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning a 19 weeks and 2 days old female patient with no pertinent medical history and no known allergies who on 29-SEP-2010 was vaccinated orally with the first dose of ROTATEQ (lot # not reported). There was no concomitant medication. No adverse experience was reported. There were no laboratory diagnostics studies performed. The patient's outcome was unknown. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Exposure to vaccinated person, Vomiting
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 36 month old male who in 2010 developed vomiting and diarrhea 2 days after ROTATEQ was vaccinated to a 62 day old sibling with no pertinent medical history and no drug reactions/allergies. The 62 day old who received the vaccine did not have any adverse event and did not take concomitant medication. At the time of the report, the outcome was unknown. The patient sought medical attention by calling office. The caller believed that the 36 month old caught the virus from the 2 month old. Follow-up information was a clarification on 13-OCT-2010 10:23 am: the 62 day old received the vaccine, the 36 month old sibling had the adverse event. Additional information has been requested.
Age: 0.51
Sex: F
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning a 6 months old female patient who on 13-OCT-2010 was vaccinated with the first dose of ROTATEQ (lot number unknown). The nurse stated that the child threw up after administration of the ROTATEQ. At the time of report, the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Exposure to vaccinated person, Pyrexia
Clinical narrative: Information has been received from a female patient in her "mid 30's" with a history of Crohn's disease. In October 2010 ("last week"), her baby received ROTATEQ orally. "With hours" of her baby receiving the vaccine, she began experiencing fever and diarrhea. Potential vaccine virus transmission was noted. The patient sought unspecified medical attention. Diagnostic determination for Rotavirus was performed (result not provided). Outcome of the events were not reported. There was some discrepancy between what was reported to the pediatrician and the patient's gastroenterologist. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a 12 month old female child who on 25-OCT-2010 was vaccinated orally with a first dose of ROTATEQ (lot # 668266/0521Z). No adverse effect was known. The patient did not seek medical attention. Follow-up information has been received from the physician who indicated no adverse effect. No information is available.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning an 18 weeks old patient, who on 09-JUL-2010 was vaccinated with a first 2 ml dose of ROTATEQ (Lot # not reported) PO. No adverse effect was reported. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Regurgitation
Clinical narrative: Information has been received from a medical assistant concerning an 8 week male patient with no medical history or drug/allergies reported, who on 02-NOV-2010 was vaccinated with a dose of ROTATEQ (Lot # not provided), 2 mL, orally. There was no concomitant medication. It was reported that the patient regurgitated immediately after receiving a dose of ROTATEQ. The child had just been fed prior to being seen by the doctor. There were no laboratories diagnostics performed. The patient recovered on the same day. Follow up information has been received from the medical assistant who stated that the patient spit up entire dose of ROTATEQ in October, 2010 (previously reported as 02-NOV-2010). Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Faeces discoloured
Clinical narrative: Information has been received from a physician concerning a 10 week old male patient with no pertinent medical history and no drug reactions or allergies who on 28-SEP-2010 was vaccinated with the first oral dose of ROTATEQ (Lot # 668042/0511Z, expiration date: 30-MAR-2012). There was no concomitant medication. The physician reported that 1 week after dose 1 of the ROTATEQ on approximately 05-OCT-2010, the patient developed diarrhea that was green and mucousy. At the time of the report the patient had not recovered. Patient sought medical attention by a visit to the office. No lab diagnostic studies were performed. Additional information has been requested.
Age: 0.16
Sex: M
Vaccine: RV5
Symptoms: Body temperature increased, Rash, Rash generalised
Clinical narrative: Information has been received from a Licensed Visiting Nurse concerning a 60 day old male with no pertinent medical history and no drug allergies who on 26-OCT-2010 was vaccinated with the first dose of ROTATEQ by oral administration (lot number reported as 668337/0524Z). There was no concomitant medication. On 26-OCT-2010 the patient developed an abdominal rash 12 hours after administration of ROTATEQ. The patient was evaluated in the office on 29-OCT-2010. He was found to have a temperature of 100.2 F and a widespread rash on his abdomen. No therapy was prescribed. Lab diagnostics studies were not performed. At the time of report, the outcome was unknown. Additional information has been requested.
Age: 0.51
Sex: F
Vaccine: RV5
Symptoms: Clostridium test negative, Rotavirus infection, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning a 19 month old female who on 18-MAY-2009 was vaccinated orally with the first dose of ROTATEQ (lot # 663359/1661X), the second dose on 20-JUL-2009 (lot # 663711/0107Y) and the third dose on 21-SEP-2009 (lot # 663909/0184Y). On 12-NOV-2010 this past Friday, the patient experienced an outbreak of confirmed rotavirus. The patient was not hospitalized. 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 a licensed practical nurse via a medical record. It was reported the female child had been given all 3 doses of ROTATEQ vaccines on time. On 12-NOV-2010, the patient was diagnosed with rotavirus. The stool test revealed negative for clostridium difficile toxin assay and positive for rotavirus antigen on 12-NOV-2010. On an unspecified date, the patient recovered. Additional information is not expected.
Sex: M
Vaccine: RV5
Symptoms: Oral administration complication, Regurgitation
Clinical narrative: Information has been received from a Certified Medical Assistant concerning a male patient who on 14-SEP-2010 was vaccinated with the first dose of ROTATEQ (lot # and expire date not reported), 2 ml, per oral. On 15-NOV-2010 the patient was vaccinated with the second dose of ROTATEQ (lot # and expire date not reported), 2 ml, per oral and regurgitated an unknown quantity of his second dose. No adverse effect reported. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from licensed practical nurse concerning a 10 week old male patient with not illness at the time of vaccination who on 17-SEP-2010 at 11:00 am was vaccinated orally with a first dose of ROTATEQ (Lot # 668036/0594Z). The licensed practical nurse reported that on 17-SEP-2010 the patient experienced diarrhea after getting the vaccine 4 to 7 stools per day that lasted 20 days. On approximately 07-OCT-2010 the patient had recovered. The patient did not seek medical attention. Additional information is not expected.
Age: 0.76
Sex: M
Vaccine: RV5
Symptoms: No adverse event
Clinical narrative: Information has been received from a physician concerning a 9 month old male patient with no pertinent medical history and no drug reactions/allergies, who on 18-NOV-2010 was vaccinated with the initial dose of ROTATEQ (Lot # not reported) orally. There was no concomitant medication. There were no Lab diagnosis/studies performed. No adverse event was reported. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Crying, Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning an 8 week old male patient, who on 18-NOV-2010 was vaccinated with a dose of ROTATEQ (Lot # not reported). The nurse stated that on 18-NOV-2010 the patient threw up and had been crying all day. The patient did not seek medical attention. It was reported that the AE had not improved at the time of the report, the patient's present status was not reported. Additional information has been requested.
Age: 0.51
Sex: F
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a consumer concerning his/her 6 month old grand daughter with pulmonary lymphangiectasia and gastrostomy tube (G-tube) "normally gets things administered through the tube. She does not receive anything by the mouth" and with no drug reactions or allergies who on 22-NOV-2010 was vaccinated orally with a first dose of ROTATEQ (manufacturer unknown) (Lot# unknown). There was no concomitant medication. The consumer reported that the patient threw up while getting the 1st dose of ROTATEQ. There were no laboratory tests or diagnostic studies performed. The consumer stated that after some time passed, the patient seemed to be ok. It was also reported that the patient was back to her present state afterwards. The patient did not seek medical attention. No further information is available.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Oral administration complication, Vomiting
Clinical narrative: Information has been received from a physician concerning an approximately 6 month old female infant with lymph system disorder affecting her breathing and requiring a G-tube, gastrostomy tube who in approximately August 2010 "2 to 3 months ago", was vaccinated orally with a first dose of ROTATEQ (dose and lot # not reported). In the week of 22-NOV-2010 the patient was vaccinated orally with a second dose of ROTATEQ (dose and lot # not reported) and immediately vomited the majority of the suspension. The patient usually took minimal amounts of fluid orally. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 0.39
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Immediate post-injection reaction, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 20 week female "reported as four month old" with no drug reaction/allergies and no pertinent medical history, who on 08-SEP-2010 was vaccinated with a first dose of ROTATEQ (dose and lot # not reported). The patient had no ill effects when she received that dose of vaccine. There was no concomitant medication. On 23-NOV-2010 the patient was vaccinated with a second dose of ROTATEQ (dose not reported, lot # 668266/0521Z). The patient vomited shortly after receiving her second dose of vaccine (about 2 minutes). The child expelled about a quarter cup of vomit. The patient showed no other adverse signs and was fine when left the office an hour later on 23-NOV-2010. No diagnostic laboratory tests were performed. The patient sought unspecified medical attention. Follow-up information has been received from the nurse who reported that the patient was not their patient. The adverse event might have been from the health center next door to the nurse's office. Follow-up information has been received from the registered nurse concerning the infant patient with no illness at time of vaccination, pre-existing allergies, birth defects or medical conditions and no medical history reported who on 24-NOV-2010 14:47 was vaccinated orally with the second dose of ROTATEQ (lot #668266/0521Z). Concomitant vaccines included the second dose of PENTACEL (lot #C3684AA) given intramuscularly into the right arm, and the second dose of PREVNAR 13 (lot # E70436) given intramuscularly into the left arm. On 24-NOV-2010 14:47, the patient vomited up approximate 1/4 cup of white, watery liquid immediately post vaccination. No further complications noted. On 24-NOV-2010, the patient recovered from the adverse event. The patient did not seek medical attention. No further information is available.
Age: 0.19
Sex: M
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a Licensed Practical nurse concerning a 60 day (reported as 2 months) old patient who on 30-NOV-2010 was vaccinated with ROTATEQ (lot number not provided, expiration date 25-NOV-2010) that expired. No adverse effect was reported. The patient did not sought medical attention. Follow-up information received from the Licensed Practical nurse stated that the patient was a 70 day old male with no illness at time of vaccination and no pre-existing allergies, birth defects and medical conditions and no adverse event following prior vaccination who on 30-NOV-2010 was vaccinated with the first dose of ROTATEQ (lot number 663848/0147Y, expiration date 25-NOV-2010) which expired 5 days. On 03-DEC-2010, the patient was re-administered with the second dose of ROTATEQ (lot number 668268/0947Z). Concomitant therapy included PEDIARIX, PREVNAR and Hib (unspecified carrier) (manufacturer unknown). It was reported that the patient did not require emergency room/doctor visit. No further information is available.
Age: 0.48
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse concerning a patient who on 01-SEP-2010 received the first dose of ROTATEQ and would get the second dose on 01-DEC-2010 (lot # not reported). No known adverse effect. It was unspecified if the patient sought medical attention. Follow up information has been received from a nurse reporting that the 24 week old female patient received the second dose of ROTATEQ (lot # 665274/0300Z) on 01-DEC-2010. Concomitant therapy included PEDIARIX (lot # AC21B248AA, left arm), ACTHIB (lot # SPUH157AA, right arm), PREVNAR 13 (lot # E72961, right arm). All the concomitant therapy was the second dose vaccinated on 01-DEC-2010. There was no adverse reaction with either dose of ROTATEQ. Additional information is not expected.
Sex: M
Vaccine: RV5
Symptoms: Accidental exposure, Erythema, Pruritus
Clinical narrative: Information has been received from a nurse concerning a 6 month old baby's father who on 03-DEC-2010 was contacted with the drool from the baby who on 03-DEC-2010 was vaccinated with ROTATEQ (lot number not provided). The nurse believed that the baby received the full dose of the vaccine but a scant amount of drool from the baby mouth came into contact with the hand of the baby's father not at time of administration. A few hours after the drool came into contact with the father's hand, the father complained of his hand being reddened and itchy. At time of the report, the father's outcome was unknown. Additional information has been requested.
Age: 0.52
Sex: F
Vaccine: RV5
Symptoms: No adverse event
Clinical narrative: Information has been received from a consumer concerning her 6 month old daughter who on 29-NOV-2010 was vaccinated with a dose of ROTATEQ (Lot #, expire date and route not reported). No adverse effect was reported. Follow up information was received from a physician who reported that the patient with no illness at time of vaccination, no pre-existing allergies, birth defects or medical conditions, who received the first dose of ROTATEQ (Lot # 665258/0201Z, expire date 12-AUG-2012, route not reported). No laboratory tests were performed. No adverse events were reported. No further information is available.
Age: 0.16
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 9 week old (also reported as "about 2 months old") female infant who on approximately 21-SEP-2010 was vaccinated with a first dose of ROTATEQ (dose, route and lot # not reported). Concomitant therapy included other unspecified vaccines indicated for 2 month old given simultaneously. On 28-SEP-2010 "about one week after administration" the patient presented to the office with diarrhoea and fever. Supportive care was given. Diarrhoea and fever improved while on therapy. On an unspecified date the patient recovered from diarrhoea and fever. Additional information was been requested.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a nurse concerning a 15 weeks old female patient who on 01-SEP-2010 was vaccinated orally with the first dose of 2ml ROTATEQ (lot # 663681/0016Y, expiration date 30-OCT-2010). On 30-NOV-2010 the patient received second dose of ROTATEQ that had expired on 30-OCT-2010. No adverse experience known. No treatment was given for the events. The patient did not seek medical attention. Additional information has been requested.
Age: 0.6
Sex: U
Vaccine: RV5
Symptoms: No adverse event
Clinical narrative: Information has been received from a nurse (R.N.) concerning a 7 month (currently age "10 months 2 days") old patient who on 16-APR-2010 was orally vaccinated with the first dose of ROTATEQ suspension (dose, route and lot# not reported), the second dose of 05-OCT-2010, the third dose on 13-DEC-2010 at age "10 month and 2 days". No adverse reactions reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Gastroenteritis rotavirus
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified dates was vaccinated with the three doses of ROTATEQ (Lot# unknown) per the recommended schedule and subsequently on an unspecified date, the patient had been diagnosed with rotavirus gastroenteritis. The patient's outcome was not reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: No adverse event
Clinical narrative: Information has been received from a physician concerning 6 month old male patient who on 17-DEC-2010 was vaccinated with a dose of ROTATEQ suspension (Lot# 668363/1046Z). No adverse reaction noted. Additional information has been requested.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Culture stool, Diarrhoea
Clinical narrative: Information has been received from a medical assistant concerning a 10 week old female with no medical history and no drug reaction or allergies who on 02-SEP-2010 was vaccinated with the first dose of ROTAEQ (lot # 667989/0687Z). Concomitant therapy included PEDIARIX, ACTHIB, and PREVNAR at the same appointment. The patient experienced persistent diarrhea on 08-SEP-2010, 6 days after receiving her first vaccination with ROTATEQ (lot # 667989/0687Z). The patient had stool cultures taken (results not reported). At the time of reporting, the patient's status was unspecified. The patient sought medical attention via calling office. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Accidental exposure, Eye irrigation, Eye irritation
Clinical narrative: Information has been received from a medical assistant concerning another female medical assistant, who while was opening a vial of ROTATEQ (Lot # 668274/09482 EXP 19-APR-2012) on 17-DEC-2010, the vaccine popped open and squirted into the medical assistant's eye. The medical assistant reported that the other medical assistant was now experiencing burning in her eye. The eye was being flushed with water. At the time of the report, the patient had not recovered. The patient was seen in the pediatrician's office where she worked. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Accidental exposure, Eye irritation, Eye swelling, Ocular hyperaemia
Clinical narrative: Information has been received from a physician concerning a nurse who on 17-DEC-2010 was splashed with some dose of ROTATEQ (Lot # not reported0 in her eye. The nurse stated that on 17-DEC-2010 she twisted off the top and it popped open like champagne cork and the vaccine shot in her eye and her eye started burning, eyewash was given, and it felt fine while they were given it to her, but after the eye wash, her eye started to burn again and it was red and puffy. She went to an urgent care facility and they gave her some type of drops to keep the eye wet. After the weekend her eye was fine and she had no loss of vision. Additional information has been requested.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Bacterial test, Diarrhoea, Laboratory test normal
Clinical narrative: Information has been received from a physician concerning an approximately 19 week old male patient who on 24-AUG-2010, was vaccinated PO with the second dose of ROTATEQ (Lot# not reported) and then sometime after the vaccination the patient experienced severe diarrhea and was advise to take PEDIALYTE. Then on 31-AUG-2010, the patient went to see the physician since the patient was still having diarrhea. The physician reported that a bacterial report was done on the patient's stool and the test was negative. The physician reported that he believed the patient went to the emergency room after being seen on 31-AUG-2010 but he still had not received the emergency room report. The physician did not know if the patient was admitted. At the time of the report, the patient's outcome was unknown. Follow-up information was received from a physician who reported that the now 6 month old male patient with no pre-existing allergies, no birth defects, no medical conditions, no illness at time of vaccination and no adverse events following prior vaccination on 24-AUG-2010, was vaccinated PO with the second dose of ROTATEQ (Lot# not reported) in the morning. On the same day, the patient was vaccinated IM in the left thigh with the second dose of PENTACEL (Lot# C3656AA) and IM in the right thigh with the second dose of PREVNAR (Lot# E69592) in the morning. It was reported that on 24-AUG-2010 in the afternoon, the patient developed diarrhea after immunization. The patient had a stool analysis performed and there were no Salmonella, no Shigella and there was no Campylobacter. There was no vomiting or fever. "Acting and feeding". The patient was taken to hospital to the emergency room on 02-SEP-2010 and was given intravenous fluids, but no medicines. On 14-SEP-2010, the formula was change to PROSOBEE. On 15-SEP-2010, the diarrhea stopped. No further information is available.
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a female patient who on 22-SEP-2010, was vaccinated with the first dose of ROTATEQ (lot# not reported) and on 20-DEC-2010, the patient was vaccinated with the second dose of ROTATEQ (lot# not reported), 11 weeks after the first dose. No adverse effect was reported. 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 a patient who on an unspecified date was vaccinated PO with a dose of ROTATEQ (Lot# not reported) at 34 weeks instead of 32 weeks. There was no adverse event involved. No further information is available.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning a 62 day old female patient who on 28-DEC-2010 was vaccinated with a dose of ROTATEQ (Lot # 668341/0526Z, expire date 28-APR-2012), per oral. Licensed practical nurse stated that on 28-DEC-2010 the patient immediately vomited almost all of the ROTATEQ and her last feeding. Subsequently, on 28-DEC-2010 the patient recovered. There were no laboratory diagnostics tests performed. The patient sought unspecified medical attention. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: Information has been received from a medical assistant concerning a 20 week old female patient with no pertinent medical history and no drug reactions/allergies who on 07-JUL-2010 was vaccinated orally with the first 2 ml dose of ROTATEQ (lot # 665258/0201Z). On 21-SEP-2010, the patient was vaccinated with the second dose of ROTATEQ (lot # 668124/0520Z). There was no concomitant medication. On 21-SEP-2010, after the second dose the patient experienced a rash around her mouth. The patient experienced no rash after the first dose of ROTATEQ. At the time of the report, the patient was recovering. The patient sought medical attention (office visit). No laboratory diagnostics studies were performed. Follow-up was received from a medical assistant who stated that the 20 week old female patient with no pre-existing allergies, no birth defects and no medical conditions on 21-SEP-2010, was vaccinated with the second dose of ROTATEQ lot #665258/0201Z (also reported by the physician as 668124/0520Z) at 10:30. There was no illness at time of vaccination. On 21-SEP-2010 at 11:30, the patient experienced red large bumps all around her mouth, itchy but comfortable and also the patient experienced itchy face. It was reported that the patient recovered "some day pm". No further information is expected.
Age: 0.29
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 15 week old patient who on 05-JAN-2011 was vaccinated with a first dose of ROTATEQ (therapy route and lot # not provided) past the recommended age. No adverse effect reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Screaming
Clinical narrative: Information has been received from a nurse with a Bachelor of Science in Nursing concerning a female who on 07-JAN-2011 was vaccinated orally with a third dose of ROTATEQ (lot # 668334/0515Z, expired date 21-APR-2012). On 07-JAN-2011 the patient started screaming but received the complete dose. No treatment was given for this adverse event. Patient sought medical attention which happened in office. At the time of reporting, the patient was recovered. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Screaming, Vomiting
Clinical narrative: Information has been received from a nurse with a Bachelor of Science in Nursing concerning an infant who "about 2 months ago", in approximately November 2010 was vaccinated orally with a dose of ROTATEQ (lot # 668334/0515Z, expired date 21-APR-2012). The nurse reported that the patient started screaming and vomited during administration. It was decided to repeat the dose with lot # 668334/0515Z. No treatment was given for this adverse event. Patient sought medical attention which happened in office. At the time of reporting, the patient was recovered. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: RV5
Symptoms: Screaming
Clinical narrative: Information has been received from a nurse with a Bachelor of Science in Nursing concerning a male who on 12-JAN-2011 was vaccinated orally with a third dose of ROTATEQ (lot # 668334/0515Z, expired date 21-APR-2012). On 12-JAN-2012 the patient started screaming and administration from that vial was discontinued. The dosage was completed from another vial of lot # 668334/0515Z. The nurse then tasted the ROTATEQ after administration to the patient. Although the lot numbers were the same and the vials came from the same box, she felt one vial tasted sweet and the other one was salty. The patient was screaming when he received the salty tasting ROTATEQ. No treatment was given for this adverse event. Patient sought medical attention which happened in office. At the time of reporting, the patient was recovered. This is one of several reports received from the same source. 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 physician concerning a patient who on an unknown date, was vaccinated with a second dose of ROTATEQ (dose, route and lot# not reported) about 3-4 weeks after the 1st dose and no adverse effect reported. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Erythema
Clinical narrative: Information has been received from a physician concerning an 8 week old ("2 month old") baby boy with a history of some difficulties around the birth who on approximately 17-JAN-2011 ("sometime in the last week") was vaccinated orally with the first standard dose of ROTATEQ (lot # not reported). Concomitant therapy included other vaccines but the reporter did not know which ones. On approximately 17-JAN-2011 ("In the last few days") the baby had an adverse experience after receiving the vaccines (product unspecified) that day including ROTATEQ. The baby had become quite red. No treatment was given to the patient. There was no time for the patient to have another dose yet. The patient had sought unspecified medical attention. At the time of reporting, the baby's adverse event had improved. There would be some sort of follow up. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a consumer concerning her/his child who was vaccinated with the only dose of ROTATQ PO at 6 months of age. No known adverse effect. The consumer hung up before any further information could be obtained. No further information is available.
Age: 0.55
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 6 month old patient who on 31-JAN-2011 was vaccinated with a dose of ROTATEQ PO. The patient older than 12 weeks of age received dose 1 of ROTATEQ. No symptoms reported, and no other details. No further information is available.
Sex: F
Vaccine: RV5
Symptoms: Rotavirus infection
Clinical narrative: Information has been received from a registered nurse concerning a female who was vaccinated with 3 doses of ROTATEQ suspension PO on unknown dates. The nurse stated that after the administration the patient developed the rotavirus. No additional AE information was provided. Therapy with ROTATEQ was stopped. Then the patient recovered from patient developed the rotavirus. No further information is available.
Age: 0.08
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 16 week old patient who on an unspecified date was vaccinated with the first dose of ROTATEQ (Lot# and expire date not reported), per oral, as opposed to 6-12 weeks of age. Therapy with ROTATEQ was discontinued. The patient did not seek medical attention. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning an 8 week old female patient who in January 2011, was vaccinated with a first dose of ROTATEQ (dose, route and Lot# not reported). The nurse stated that 21 days (in approximately January 2011) after receiving her first dose of ROTATEQ, the patient developed diarrhea and tested positive for rotavirus (stool sample). At the time of the report the patient had recovered. It was unspecified if the patient sought medical attention. No further information is available.
Age: 46.0
Sex: M
Vaccine: SMALL
Symptoms: Arthralgia, Chest discomfort, Computerised tomogram thorax normal, Echocardiogram normal, Electrocardiogram normal
Clinical narrative: Member developed fevers, joint aches and chest discomfort.
Age: 46.0
Sex: M
Vaccine: SMALL
Symptoms: Pyrexia
Clinical narrative: Member developed fevers, joint aches and chest discomfort.
Age: 1.01
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Listless, Pyrexia, Staring
Clinical narrative: Fever for 5 days, listlessness, staring spells.
Age: 5.0
Sex: M
Vaccine: PPV
Symptoms: Eating disorder, Erythema, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: First he complained of pain, we noticed it was very swollen, raised and red. He complained of pain throughout the day.  The next morning the swelling was down but the area was bright pink in a well defined 2 inch area around the shot, and it was warm to the touch.  He was a bit grumpy, and didn't eat well for those two days.  The next morning it looked fine.
Age: 5.0
Sex: M
Vaccine: PPV
Symptoms: Irritability, Pain, Swelling
Clinical narrative: First he complained of pain, we noticed it was very swollen, raised and red. He complained of pain throughout the day.  The next morning the swelling was down but the area was bright pink in a well defined 2 inch area around the shot, and it was warm to the touch.  He was a bit grumpy, and didn't eat well for those two days.  The next morning it looked fine.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Feeling of body temperature change, Hypersomnia, Pyrexia, Rhinorrhoea
Clinical narrative: extreme fatigue 6pm - 9pm, around 9pm fever started (didn't measure), slight runny nose and sneezing, slept for 13 hours and body is still fatigued and wants to sleep, while sleeping, very very cold but also hot at the same time probably due to fever, 2:30 pm on the 26th, fever 100F, extreme fatigue, runny nose, sneezing
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Sneezing
Clinical narrative: extreme fatigue 6pm - 9pm, around 9pm fever started (didn't measure), slight runny nose and sneezing, slept for 13 hours and body is still fatigued and wants to sleep, while sleeping, very very cold but also hot at the same time probably due to fever, 2:30 pm on the 26th, fever 100F, extreme fatigue, runny nose, sneezing
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Myalgia
Clinical narrative: Severe muscle soreness, joint pain in shoulder lasting more than a week.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Fatigue, Headache, Musculoskeletal stiffness, Nausea
Clinical narrative: Severe headache, nausea and vomiting, fever, joint pain, stiffness, fatigue
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Severe headache, nausea and vomiting, fever, joint pain, stiffness, fatigue
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Injection site pain, Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Woke up with severe stabbing pain in front of left arm/shoulder, at the site of vaccine injection, that radiated to the back shoulder blade and down to tricep.  Pain did not go away most of the night but was dulled after taking Percocet.  Decreased range of motion in that arm.  In subsequent days, pain seemed to be getting better each day, but then on 3/27/2011, the same excruciating pain woke me up around 12:00 AM.  Didn't respond as well to 2 Percocet.
Age: 0.3
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Insomnia, Irritability, Pyrexia
Clinical narrative: extreme fussiness, inability to sleep, fever of 103.1 F
Age: 1.37
Sex: F
Vaccine: DTAP, FLUX, HEPA, HIBV, MMR, PPV, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Patient exhibited a high fever after shots. 12 days later (on the 25th), she had a fever of 103.6. This was taken down by administering infant's Tylenol for two days. As of today, 3/27/2011, her fever was 96.4, which her normal temperature is 98.2 Her rash spread from her face to all over her body within two days. The rash was noticed at the evening time of 03/25/2011-since it is Sunday, there is no place to take my daughter. I have taken pictures with my camera-on 03/28/2011, I will take my daughter to either the health dept. or to her pediatrician's office to confirm.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Vaccine virus shedding
Clinical narrative: Patient's mother developed shingles rash on left side of face, abdominal pain, chills. Mother's shingles rash spread on top of scalp and all around the left eye. Made two emergency visits to optomologist and one to primary care physician. Took Acyclovir for 1 week. Still have nerve sensations on face, scalp and also have noticable, large scar on forehead. In addiition, ten month old brother developed severe case of chickenpox (18 days after patient's vaccination) with a fever of 101. Made trip to brother's pediatrician who confirmed it was chickenpox. Patient developed 102 fever, chills, and chickenpox rash on arms fourteen days after vaccination.