chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain, Abdominal pain upper, Abdominal tenderness, Back pain, Burning sensation
Clinical narrative: First Gardasil shot was given and within a two months she started having stomach pain. In ER on 7/4/11. 2nd Gardasil shot was given on 10/20/2011 and symptoms started getting worse. In ER on 11/16/11. Doctors were still making guesses as to what and why she is having this stomach pain. 3rd Gardasil shot was given on 03/14/2012 and we were in the ER again within a week (03/21/12). She's seeing a Gastrologist whom has one more test to run and then they are clueless. The onset of her symptoms started after the first shot and have increased in severity after each one. This vaccine has attacked her immune system and created medical issues. Symptoms to date are as follows: Stomach pain high & low as well as left side and right side, Headaches, fatigue, leg pain, nausea, Chest pain, insomnia, loss of appetite, light sensitivity, Moodiness.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chest pain, Computerised tomogram abdomen abnormal, Condition aggravated, Confusional state, Cough
Clinical narrative: First Gardasil shot was given and within a two months she started having stomach pain. In ER on 7/4/11. 2nd Gardasil shot was given on 10/20/2011 and symptoms started getting worse. In ER on 11/16/11. Doctors were still making guesses as to what and why she is having this stomach pain. 3rd Gardasil shot was given on 03/14/2012 and we were in the ER again within a week (03/21/12). She's seeing a Gastrologist whom has one more test to run and then they are clueless. The onset of her symptoms started after the first shot and have increased in severity after each one. This vaccine has attacked her immune system and created medical issues. Symptoms to date are as follows: Stomach pain high & low as well as left side and right side, Headaches, fatigue, leg pain, nausea, Chest pain, insomnia, loss of appetite, light sensitivity, Moodiness.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Decreased appetite, Diarrhoea, Dizziness, Dysmenorrhoea, Enema administration
Clinical narrative: First Gardasil shot was given and within a two months she started having stomach pain. In ER on 7/4/11. 2nd Gardasil shot was given on 10/20/2011 and symptoms started getting worse. In ER on 11/16/11. Doctors were still making guesses as to what and why she is having this stomach pain. 3rd Gardasil shot was given on 03/14/2012 and we were in the ER again within a week (03/21/12). She's seeing a Gastrologist whom has one more test to run and then they are clueless. The onset of her symptoms started after the first shot and have increased in severity after each one. This vaccine has attacked her immune system and created medical issues. Symptoms to date are as follows: Stomach pain high & low as well as left side and right side, Headaches, fatigue, leg pain, nausea, Chest pain, insomnia, loss of appetite, light sensitivity, Moodiness.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Feeling of body temperature change, Haematochezia, Headache, Hypoaesthesia
Clinical narrative: First Gardasil shot was given and within a two months she started having stomach pain. In ER on 7/4/11. 2nd Gardasil shot was given on 10/20/2011 and symptoms started getting worse. In ER on 11/16/11. Doctors were still making guesses as to what and why she is having this stomach pain. 3rd Gardasil shot was given on 03/14/2012 and we were in the ER again within a week (03/21/12). She's seeing a Gastrologist whom has one more test to run and then they are clueless. The onset of her symptoms started after the first shot and have increased in severity after each one. This vaccine has attacked her immune system and created medical issues. Symptoms to date are as follows: Stomach pain high & low as well as left side and right side, Headaches, fatigue, leg pain, nausea, Chest pain, insomnia, loss of appetite, light sensitivity, Moodiness.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypophagia, Insomnia, Joint injury, Joint swelling, Ligament sprain
Clinical narrative: First Gardasil shot was given and within a two months she started having stomach pain. In ER on 7/4/11. 2nd Gardasil shot was given on 10/20/2011 and symptoms started getting worse. In ER on 11/16/11. Doctors were still making guesses as to what and why she is having this stomach pain. 3rd Gardasil shot was given on 03/14/2012 and we were in the ER again within a week (03/21/12). She's seeing a Gastrologist whom has one more test to run and then they are clueless. The onset of her symptoms started after the first shot and have increased in severity after each one. This vaccine has attacked her immune system and created medical issues. Symptoms to date are as follows: Stomach pain high & low as well as left side and right side, Headaches, fatigue, leg pain, nausea, Chest pain, insomnia, loss of appetite, light sensitivity, Moodiness.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Mental status changes, Mood altered, Musculoskeletal pain, Nausea, Pain
Clinical narrative: First Gardasil shot was given and within a two months she started having stomach pain. In ER on 7/4/11. 2nd Gardasil shot was given on 10/20/2011 and symptoms started getting worse. In ER on 11/16/11. Doctors were still making guesses as to what and why she is having this stomach pain. 3rd Gardasil shot was given on 03/14/2012 and we were in the ER again within a week (03/21/12). She's seeing a Gastrologist whom has one more test to run and then they are clueless. The onset of her symptoms started after the first shot and have increased in severity after each one. This vaccine has attacked her immune system and created medical issues. Symptoms to date are as follows: Stomach pain high & low as well as left side and right side, Headaches, fatigue, leg pain, nausea, Chest pain, insomnia, loss of appetite, light sensitivity, Moodiness.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain in extremity, Pallor, Pharyngitis, Photophobia, Pregnancy test negative
Clinical narrative: First Gardasil shot was given and within a two months she started having stomach pain. In ER on 7/4/11. 2nd Gardasil shot was given on 10/20/2011 and symptoms started getting worse. In ER on 11/16/11. Doctors were still making guesses as to what and why she is having this stomach pain. 3rd Gardasil shot was given on 03/14/2012 and we were in the ER again within a week (03/21/12). She's seeing a Gastrologist whom has one more test to run and then they are clueless. The onset of her symptoms started after the first shot and have increased in severity after each one. This vaccine has attacked her immune system and created medical issues. Symptoms to date are as follows: Stomach pain high & low as well as left side and right side, Headaches, fatigue, leg pain, nausea, Chest pain, insomnia, loss of appetite, light sensitivity, Moodiness.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Respiratory tract congestion, Rhinitis allergic, Road traffic accident, Sinusitis, Sleep disorder
Clinical narrative: First Gardasil shot was given and within a two months she started having stomach pain. In ER on 7/4/11. 2nd Gardasil shot was given on 10/20/2011 and symptoms started getting worse. In ER on 11/16/11. Doctors were still making guesses as to what and why she is having this stomach pain. 3rd Gardasil shot was given on 03/14/2012 and we were in the ER again within a week (03/21/12). She's seeing a Gastrologist whom has one more test to run and then they are clueless. The onset of her symptoms started after the first shot and have increased in severity after each one. This vaccine has attacked her immune system and created medical issues. Symptoms to date are as follows: Stomach pain high & low as well as left side and right side, Headaches, fatigue, leg pain, nausea, Chest pain, insomnia, loss of appetite, light sensitivity, Moodiness.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Streptococcus test negative, Tenderness, Ultrasound abdomen abnormal, Urine analysis normal, Vaginal haemorrhage
Clinical narrative: First Gardasil shot was given and within a two months she started having stomach pain. In ER on 7/4/11. 2nd Gardasil shot was given on 10/20/2011 and symptoms started getting worse. In ER on 11/16/11. Doctors were still making guesses as to what and why she is having this stomach pain. 3rd Gardasil shot was given on 03/14/2012 and we were in the ER again within a week (03/21/12). She's seeing a Gastrologist whom has one more test to run and then they are clueless. The onset of her symptoms started after the first shot and have increased in severity after each one. This vaccine has attacked her immune system and created medical issues. Symptoms to date are as follows: Stomach pain high & low as well as left side and right side, Headaches, fatigue, leg pain, nausea, Chest pain, insomnia, loss of appetite, light sensitivity, Moodiness.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: White blood cell count decreased, X-ray limb normal
Clinical narrative: First Gardasil shot was given and within a two months she started having stomach pain. In ER on 7/4/11. 2nd Gardasil shot was given on 10/20/2011 and symptoms started getting worse. In ER on 11/16/11. Doctors were still making guesses as to what and why she is having this stomach pain. 3rd Gardasil shot was given on 03/14/2012 and we were in the ER again within a week (03/21/12). She's seeing a Gastrologist whom has one more test to run and then they are clueless. The onset of her symptoms started after the first shot and have increased in severity after each one. This vaccine has attacked her immune system and created medical issues. Symptoms to date are as follows: Stomach pain high & low as well as left side and right side, Headaches, fatigue, leg pain, nausea, Chest pain, insomnia, loss of appetite, light sensitivity, Moodiness.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Alopecia, Amenorrhoea, Arthralgia, Blood test, Computerised tomogram
Clinical narrative: Severe vomiting nausea weight gain, no menstrual period, insomnia, chronic fatigue, hair loss, irritability, muscle aches and joint pain.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Endoscopy, Fatigue, Gastric emptying study, Insomnia, Irritability
Clinical narrative: Severe vomiting nausea weight gain, no menstrual period, insomnia, chronic fatigue, hair loss, irritability, muscle aches and joint pain.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Myalgia, Nausea, Nuclear magnetic resonance imaging, Ultrasound scan, Vomiting
Clinical narrative: Severe vomiting nausea weight gain, no menstrual period, insomnia, chronic fatigue, hair loss, irritability, muscle aches and joint pain.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Weight increased, X-ray
Clinical narrative: Severe vomiting nausea weight gain, no menstrual period, insomnia, chronic fatigue, hair loss, irritability, muscle aches and joint pain.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Computerised tomogram, Full blood count, Headache, Neck pain
Clinical narrative: Severe headache and neck pain. Became worse overnight and was unbearable by the morning of 5/22/11.
Age: 8.0
Sex: M
Vaccine: PPV
Symptoms: C-reactive protein increased, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Swelling of right deltoid with erythema and tenderness, including fever to 102.8.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Dyspnoea, Nausea, Tremor
Clinical narrative: Pt states after a couple of hours of recieving the Anthrax vaccine he started to have nausea, shaking, and shortness of breath that lasted for a couple of hours.  Pt was not seen for these symptoms.
Age: 82.0
Sex: M
Vaccine: TDAP
Symptoms: Blood pressure increased, Body temperature increased, Heart rate increased, Malaise, Tremor
Clinical narrative: Wife reports temp of 101.4 increased BP and pulse, shaking. Still not feeling well after 8 days.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, HEP, HEPA, VARCEL
Symptoms: Cellulitis, Erythema, Exposure to communicable disease, Induration, Skin lesion
Clinical narrative: Increasing erythema and induration over three days, appeared to have cellulitis with lesion 2-3cm in diameter. no fluctuance on exam. Started on Clindamycin for likely MRSA exposure (mother is a healthcare worker).
Age: 1.05
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Febrile convulsion, Pyrexia, Rash morbilliform
Clinical narrative: Febrile seizure on the evening of administration. Formation of mobiliform rash with recurring fevers few days after administration.
Age: 1.02
Sex: M
Vaccine: HEPA
Symptoms: Depressed mood, Eating disorder, Vomiting
Clinical narrative: Prior to event he was not too willing to eat and looking kind of sad.  After dinner he vomited and continued to throughout the night.
Age: 64.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Autoimmune disorder, Cough, Influenza like illness, Oedema peripheral, Renal disorder
Clinical narrative: Patient started experiencing flu-like symptoms a day after his influenza vaccination. He noted that he experienced a very bad cough. About three weeks after vaccination he noticed that his "calves and feet" were swelling. He went to his MD and they stated that his kidneys were attacking themselves, some sort of "autoimmune disorder".  He is still experiencing problems.
Age: 64.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Biopsy kidney abnormal, Joint swelling, Oedema, Oedema peripheral, Renal disorder
Clinical narrative: Patient started experiencing flu-like symptoms a day after his influenza vaccination. He noted that he experienced a very bad cough. About three weeks after vaccination he noticed that his "calves and feet" were swelling. He went to his MD and they stated that his kidneys were attacking themselves, some sort of "autoimmune disorder".  He is still experiencing problems.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient reports itching and swollen at injection site shortly after administration. Works with a physician, so Monday was started on Keflex. Had chills, and headache, has become more swollen and raised, it is hot and sore.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Patient reports itching and swollen at injection site shortly after administration. Works with a physician, so Monday was started on Keflex. Had chills, and headache, has become more swollen and raised, it is hot and sore.
Age: 0.5
Sex: F
Vaccine: DPP, FLUX, HIBV, PPV
Symptoms: Body temperature increased, Hyperhidrosis, Insomnia, Irritability, Skin warm
Clinical narrative: Her skin was burning hot, she was sweating, and had a 104 temperature. She was also very fussy nonstop and didn't nap much.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: 4 hours after receiving PENTACEL in (L) thigh, area became red, swollen, warm, hard intradermal mass, severe irritability.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Irritability
Clinical narrative: 4 hours after receiving PENTACEL in (L) thigh, area became red, swollen, warm, hard intradermal mass, severe irritability.
Age: 1.55
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Rash erythematous
Clinical narrative: Rt. arm, red bumps, swelling, 2 red spots, hot to the touch.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient had 4 vaccines on 4-3-12 & later that afternoon both arms were red, swollen & warm to touch. She was started on oral BACTRIM & BENADRYL on 4-5-12 w/ improvement in sx by 4-6-12.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Erythema, Headache, Local swelling, Nausea
Clinical narrative: Local redness, with swelling and "hard knot" under skin "approx 4 inches diameter". Chills/fever x 2 days - Undocumented by patient. Nausea. Headache.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Subcutaneous nodule
Clinical narrative: Local redness, with swelling and "hard knot" under skin "approx 4 inches diameter". Chills/fever x 2 days - Undocumented by patient. Nausea. Headache.
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Per mom, child developed increased pain at site compared to past vaccine doses, and fever around 100 degrees.
Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site induration, Injection site scab, Injection site vesicles, Mycobacterium tuberculosis complex test positive
Clinical narrative: 4/1/2012 Fever, blister formation, followed by crusting and erythema over a 20 mm sized induration TB injection site, RFA, 4 days after injection. 4/2/12: PPD test injected 12:20 pm 4/4/12: TB test read positive 20mm.
Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: 4/1/2012 Fever, blister formation, followed by crusting and erythema over a 20 mm sized induration TB injection site, RFA, 4 days after injection. 4/2/12: PPD test injected 12:20 pm 4/4/12: TB test read positive 20mm.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Wife called 4-9-12, said arm spot was red at injection site from 3-22-12. Said light soreness, some itching. Said had BACITRACIN at home & wanted to use some.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Injection site rash
Clinical narrative: Rash located in both extremities.
Age: 1.2
Sex: M
Vaccine: RV5
Symptoms: No adverse event
Clinical narrative: Information has been received from a registered nurse concerning an actually 60 weeks male patient who on 06-SEP-2011, was vaccinated with the 2.0 ml first dose of ROTATEQ and on 21-NOV-2011, was vaccinated with the second 2.0 ml dose of ROTATEQ. Both vaccines were administered orally (Lot numbers not reported). No adverse events were reported. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site erythema, Injection site nodule, Irritability, Local reaction, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 weeks old female child who on 25-OCT-2011 was vaccinated intramuscularly with a dose of ROTATEQ (lot #, dose not reported). She had not yet seen the patient or contacted the clinic where the patient was treated but was told by the patient's mother that it occurred. She was going to follow-up with the clinic before she saw the patient and called back with a follow-up report. No Adverse events reported. At 5:00 PM on 25-OCT-2011 follow up AE information: the nurse practitioner reported that she examined the child "today" on 25-OCT-2011, in a separate clinic. The child displayed some irritability and a small local reaction at the injection site, as well as a low grade fever. She did not think these findings were unusual, since the patient received numerous vaccines "yesterday" on 24-OCT-2011. Otherwise, she seemed fine. The patient was seen by the doctor on 24-OCT-2011. The patient's mother called and was bringing child in to seek medical attention. At the time of reporting outcome was unknown. Follow up information has been received from the nurse practitioner concerning the 16 weeks old female with no allergies, medical conditions, illness at the time of vaccination or adverse events following prior vaccinations who at 11:00 AM on 25-OCT-2011 was vaccinated intramuscularly on left anterior thigh with a first dose of ROTATEQ (lot #, dose not reported) in another clinic. The patient experienced small nodule with some erythema to left anterior thigh at injection site. The patient was seen in clinic at 2:00 pm on 26-OCT-2011 and again at 10:00 am on 28-OCT-2011. No treatment was needed. The patient recovered from the events on 28-OCT-2011. The patient was revaccinated by mouth with a 2 ml second dose of ROTATEQ (lot # not reported) in another clinic on 23-NOV-2011. The patient did not seek medical attention. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Incorrect route of drug administration, Irritability
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 weeks old female child who on 25-OCT-2011 was vaccinated intramuscularly with a dose of ROTATEQ (lot #, dose not reported). She had not yet seen the patient or contacted the clinic where the patient was treated but was told by the patient's mother that it occurred. She was going to follow-up with the clinic before she saw the patient and called back with a follow-up report. No Adverse events reported. At 5:00 PM on 25-OCT-2011 follow up AE information: the nurse practitioner reported that she examined the child "today" on 25-OCT-2011, in a separate clinic. The child displayed some irritability and a small local reaction at the injection site, as well as a low grade fever. She did not think these findings were unusual, since the patient received numerous vaccines "yesterday" on 24-OCT-2011. Otherwise, she seemed fine. The patient was seen by the doctor on 24-OCT-2011. The patient's mother called and was bringing child in to seek medical attention. At the time of reporting outcome was unknown. Follow up information has been received from the nurse practitioner concerning the 16 weeks old female with no allergies, medical conditions, illness at the time of vaccination or adverse events following prior vaccinations who at 11:00 AM on 25-OCT-2011 was vaccinated intramuscularly on left anterior thigh with a first dose of ROTATEQ (lot #, dose not reported) in another clinic. The patient experienced small nodule with some erythema to left anterior thigh at injection site. The patient was seen in clinic at 2:00 pm on 26-OCT-2011 and again at 10:00 am on 28-OCT-2011. No treatment was needed. The patient recovered from the events on 28-OCT-2011. The patient was revaccinated by mouth with a 2 ml second dose of ROTATEQ (lot # not reported) in another clinic on 23-NOV-2011. The patient did not seek medical attention. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a consumer concerning her 20 weeks old son with no pertinent medical history and no drug allergy or reaction who on 29-JUL-2011 was vaccinated with a dose of ROTATEQ (lot number not reported). Secondary suspect therapy included a dose of hepatitis (manufacturer unknown) administered on an unspecified date (dose and route not reported). Concomitant therapy included PENTACEL, and PREVNAR. On 30-JUL-2011, the patient experienced diarrhea after receiving ROTATEQ which resolved shortly after it occurred on an unspecified date. The patient contacted the physician. No treatment was given for the events. No lab diagnostics studies were performed. No further information is available.
Age: 0.27
Sex: M
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a Physician assistant concerning a 14 weeks old male patient who his on 27-APR-2011 was vaccinated with the first dose of ROTATEQ oral (lot. Dose not provided). On 23-MAY-2011, patient was vaccinated with the second dose of ROTATEQ oral (lot. Dose not provided). On 27-OCT-2011, the patient was vaccinated with the third dose of ROTATEQ oral (lot. Dose not provided). No adverse event reported. Additional information has been requested.
Age: 0.36
Sex: F
Vaccine: RV5
Symptoms: Oral administration complication, Vomiting
Clinical narrative: Information has been received from a consumer concerning her 19 weeks old daughter with gastrooesophageal reflux and milk allergy who was vaccinated orally with the first dose of ROTATEQ (dose and lot# were unspecified) on 07-OCT-2011. Concomitant therapy included MIRALAX and ZANTAC. On 13-DEC-2011, the patient was taken to clinic for her second dose of ROTATEQ; while the technician as administering ROTATEQ to the patient, the patient was spitting some of the medication out. Five seconds after the administration of ROTATEQ was completed, the patient vomited. No lab diagnostics studies were performed and no treatment was given for adverse events. On 14-DEC-2011, the patient felt good and recovered from vomit. Follow up information has been received from a doctor requested no more letters from this report. No further information is available.
Age: 0.18
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 16 weeks female patient who within the last several months was orally vaccinated with the second dose of ROTATEQ (Lot # and expiration not reported). It was reported that on an unspecified date, 24 hours after receiving the second dose of ROTATEQ the patient experienced severe diarrhea. The patient sought unspecified medical attention. It was reported that the patient would not receive the third dose ROTATEQ. At the time of reporting the outcome of the patient was unknown. This is one of several reports from the same source. Follow up information has been received from a health care professional who reported that the patient was a 9 weeks old female (previously reported as 16 weeks old) who on 22-JUN-2011 was vaccinated with the first dose of ROTATEQ orally (Lot number 669827/0257AA) and on 24-AUG-2011 was vaccinated with the second dose of ROTATEQ orally (Lot number 669476/1529Z). It was reported that the patient after both doses, first and second, of ROTATEQ developed severe vomiting and severe diarrhea. Signs and symptoms developed about 24 hours after vaccine, on "approximately 23-JUN-2011". At the time of the report, the patient's outcome was unknown. The patient did not seek medical attention. No further information is available.
Age: 0.82
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 10 month old female who on 04-NOV-2011 inadvertently was vaccinated with the third dose of ROTATEQ (lot number not reported). No adverse symptoms noted. The follow-up information has been received from the registered nurse concerning the patient who at 10:00 AM on 07-NOV-2011 orally was vaccinated with the third dose of ROTATEQ (lot number 16572, a not valid number) by public funds at public health clinic/hospital. The nurse reported that no adverse events. The patient did not perform any relevant diagnostic tests or any illness at time of vaccination. The patient did not have any adverse events following prior vaccination. The patient did not have any pre-existing allergies, birth defects or medical conditions. Additional information is not expected.
Age: 0.18
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Frequent bowel movements, Ultrasound abdomen normal, Urine output decreased, Vomiting
Clinical narrative: Information has been received from a physician concerning a 9 weeks old (also reported as 2-month-old) female with no drug reactions or allergies who on 31-OCT-2011 was vaccinated orally with her first dose of ROTATEQ (lot# 670535/0542AA, exp 09-MAR-2013). Concomitant therapy included PREVACID. On 02-NOV-2011 the patient experienced diarrhea. The physician saw the child on 04-NOV-2011 at this time the diarrhea had been occurring for 3 days at the rate of 5 to 6 time bowel movements per day. The child also vomited on while in the office. The physician ordered probiotics and PEDIALYTE. The patient went to visit physician to seek medical attention. The child was seen again on 22-NOV-2011 with decreased urination and decreased bowel movements. There was no fever but the child did have episode of vomiting while in the office. Abdominal and pyloric sonograms were performed and came back either negative or inconclusive. The child had recovered at the time of the report. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a Physician Assistant concerning a 12 month old patient who on 19-JAN-2011 was vaccinated with the first dose of ROTATEQ and the second dose on 24-MAR-2011. The patient received the third dose of ROTATEQ at 12 months of age on 04-NOV-2011. No adverse event was reported. It was unspecified if the patient sought medical attention. Additional information has been requested. This is an amended report, the reporting status change to periodic.
Age: 0.18
Sex: M
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a registered nurse concerning a 9 weeks old male patient with no drug reactions or allergies and no pertinent medical history who on 22-DEC-2011, was vaccinated with the first 2 mL (reported as "regular dose") dose of ROTATEQ Lot # 669757/0884AA, exp. date 09-MAR-13) (dose was not reported). There was no concomitant therapy. The nurse reported that on 22-DEC-2011, patient's mother called 4 hours after patient received a dose of ROTATEQ and reported that patient had a "bloody stool". The medical attention was sought by calling physician's office. None lab diagnostic tests were performed. Patient did not received treatment. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 0.16
Sex: F
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning an 8 weeks old female patient with no drug reactions or allergies and no pertinent medical history who on 15-DEC-2011, was orally vaccinated with the first dose of ROTATEQ (lot # 669085/1659Z, exp. date 29-AUG-2012) (dose was not reported). There was no concomitant therapy. The nurse reported that on 22-DEC-2011 (reported as "seven days after her first dose of ROTAREQ"), the patient developed blood in her stool. The patient sought medical attention by visiting an unspecified physician's office. Non lab diagnostic tests were performed. Patient did not received treatment. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 0.48
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a 25 weeks old patient who on 08-AUG-2011, at 12 weeks 6 days of age, was vaccinated with the first dose of ROTATEQ (Lot# not reported) and on 03-NOV-2011, vaccinated the second dose of ROTATEQ (Lot# not reported). The third dose had not been administered yet. No adverse event reported. The patient sought medical attention by an office visit. Additional information has been requested. This is an amended report, the reporting status change to periodic.
Age: 1.06
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a child who on 30-NOV-2010 was vaccinated orally with first dose of ROTATEQ and the second dose was then administered on 20-OCT-2011 at public health clinic/hospital. No adverse effects were reported. Follow up information has been received from a healthcare worker from the office reporting that the patient did not have any adverse symptoms. Follow up information has been received from a registered nurse reporting that the 12 months old male patient did not seek any medical information. No further information is available.
Age: 0.37
Sex: F
Vaccine: RV5
Symptoms: Haematochezia, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 19 weeks old female child who received her first dose and second dose of 2ml ROTATEQ (Lot# not reported) on 19-OCT-2011 and today on 21-NOV-2011 respectively by oral route. No adverse event reported. At the time of the report it was unknown if the patient sought medical attention. Follow-up information has been received from a clinic concerning a 19 weeks old female child who at 11:00 AM on 19-OCT-2011 received her first dose of ROTATEQ (Lot # 669821/1034AA) by oral route, at 2:30 PM on 21-NOV-2011 received second dose of ROTATEQ (Lot# 669825/1347AA, not valid) by oral route, and at 11:00 AM on 11-JAN-2012 received third dose of ROTATEQ (Lot# 1457Z, which is not valid) by oral route. Patient did not have adverse reaction. Patient had blood in stool unrelated to vaccine. The first dose of ROTATEQ was given late, verified ok to give second dose of ROTATEQ. Additional information has been requested.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 30 day old infant patient who on 09-DEC-2011 was vaccinated with the first dose of ROTATEQ (lot number not provided). The infant also receive PENTACEL and PREVNAR at an alternate schedule and the pharmaceutical companies were notified. No adverse symptoms noted. Follow-up information has been received from a licensed practical nurse who reported that the female patient was vaccinated with a first dose of ROTATEQ, oral (lot number 1393AA, Expiry date 03-DEC-2011) (dose not reported) on 08-DEC-2011 (previously reported as 09-DEC-2011) at 08:15. No adverse reactions were reported. No further information is available.
Age: 0.8
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 9 month old patient who on 26-APR-2011 and 27-JUN-2011 was vaccinated orally with the first dose and the second dose of 2ml ROTATEQ (Lot# not reported) respectively. On 15-NOV-2011, the patient received the third dose of 2ml ROTATEQ (Lot# not reported) orally, late. The nurse reported that the patient was 9 months old instead of 8 months old when the patient received the third dose of ROTATEQ. No adverse effects were reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 1.5
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning an 18 weeks old premature infant who on 09-DEC-2011 was vaccinated orally with the first dose of 2 ml ROTATEQ (lot# 669819/1237AA, exp unknown). No adverse effects reported. Additional information has been requested.
Age: 0.31
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 16 week old patient who on 17-AUG-2011, was vaccinated orally with a first dose of ROTATEQ (lot number and dose not reported) and today on 31-OCT-2011, was vaccinated orally with a second dose of ROTATEQ (lot number and dose not reported). No adverse effect was reported. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning a 16 week old male who on 08-NOV-2011 received his first dose of ROTATEQ (Lot# not reported). No adverse effect reported. Follow up information has been received from a licensed practical nurse concerning a male who on 08-NOV-2011 at 1:20 p.m. received his first dose of ROTATEQ (Lot# 669821/1034AA). Concomitant vaccination included the second dose of PENTACEL (Lot# C3834AA) which was vaccinated IM in the left upper thigh on 08-NOV-2011 at 12:30 p.m. and the second dose of PREVNAR 13 (Lot# 916617) which was vaccinated IM in the right upper thigh on 08-NOV-2011 at 12:30 p.m. There was no adverse event. No further information is available.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Ammonia increased, Hepatic enzyme increased, Liver function test abnormal
Clinical narrative: Information has been received from a registered nurse concerning a now 6 month old male child who on an unknown date was orally vaccinated with 2ml ROTATEQ (lot# unspecified). On an unknown date, the child experienced an increase in liver enzymes and ammonia levels. The child had sought medical attention by office visit. At the time of reporting, the child had not recovered. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a registered nurse concerning a 19-week old male with no pertinent medical history and no drug reactions/allergies who on 23-AUG-2011 and 24-OCT-2011 was vaccinated orally with the first and second dose of ROTATEQ respectively (2ml for each dose) (Lot number 670237/0919AA). Concomitant therapy included unspecified multivitamins. On 02-NOV-2011 the patient had blood in his stools after receiving the second dose for ROTATEQ. The patient sought medical attention via contacting the physician. No treatment was given for the event. There was no laboratory test performed. At the time of the report, the patient was recovering from the event. Additional information has been requested. Follow up information has been received from the registered nurse concerning the patient who on 23-AUG-2011 was vaccinated the first dose of ROTATEQ (lot number 669992/0287AA) and on 24-OCT-2011 was vaccinated with the second dose of ROTATEQ. Concomitantly on 24-OCT-2011 the patient was administered the second dose of DAPTACEL, ACTHIB, IPOL, and a dose of PREVNAR. On 02-NOV-2011, the patient was seen in the office, no stool to test. The patient had no other symptoms and no treatment provided. On 07-NOV-2011, the patient was recovered. Follow up information has been received from a registered nurse concerning the 4 month old male patient (previously reported as 19 week old) above who on 24-OCT-2011 10:00 AM was vaccinated orally with the second dose of ROTATEQ. On 02-NOV-2011, patient was seen in office with complaint of blood (small amount) in stool. On 07-NOV-2011 follow up call was placed, his mother reported no more blood was seen. On 03-NOV-2011 (previously reported as 07-NOV-2011) the patient was recovered. The patient experienced no adverse event following prior vaccination. The patient had no illness at the time of vaccination. No further information is available.
Age: 0.3
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse (R.N), concerning a 16 weeks and 6 days old female infant who on 02-NOV-2011 was vaccinated with the first dose of ROTATEQ (Lot #, site and route were not reported). No adverse effects to report. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect dose administered, Oral administration complication, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning an infant who on an unspecified date was vaccinated with a dose of ROTATEQ (Lot# and dose unspecified), orally. On 13-DEC-2011 the patient experienced vomited after receiving the dose of ROTATEQ and a replacement dose was administered. The patient sought medical attention in the office. At the time of reporting, the outcome was unknown. Additional information has been requested.
Age: 0.21
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Ear pain, Erythema
Clinical narrative: Information has been received from a consumer concerning her approximately 13 weeks (also reported as "about 4 months old") son who on approximately 25-OCT-2011 ("about 4 weeks ago") was vaccinated with a dose of ROTATEQ (Lot# was unspecified) ("injection", dose not reported). There was no concomitant medication. The reporter stated that on approximately 08-NOV-2011, ("about two weeks ago") her son had diarrhea, a red ear and an earache. The patient sought unspecified medical attention. No treatment was given and no lab diagnostics was performed. At the time of reporting, the patient had not recovered. No further information is available.
Age: 0.15
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a consumer reporting on her daughter who in June 2010 was vaccinated with a dose of ROTATEQ (lot number dose and site of administration not reported) and in August 2010 was vaccinated with a dose of ROTATEQ (lot number dose and site of administration not reported). Concomitant vaccines included ACTHIB, ENGERIX-B, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid "dtap vaccine" in August 2010. In June 2010, the patient experienced diarrhea and in August 2010 the patient also experienced diarrhea. This is one of several reports received from the same source. At the time of the report, the patient outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Haematochezia, Weight gain poor
Clinical narrative: Information has been received from a physician concerning an infant patient, who on an unspecified date, was vaccinated with a dose of ROTATEQ (dose, route and Lot# not specified). The physician reported that "2-3 weeks" after the patient was given the dose of ROTATEQ (dates unspecified), patient experienced blood in stool. The physician also reported that the patient had poor weight gain. At the time of the report the patient's outcome, was not reported. It was unspecified if the patient sought medical attention. This is one of several reports from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Diarrhoea, Rotavirus infection, Rotavirus test positive, Vaccine breakthrough infection, Vomiting
Clinical narrative: Information has been received from a physician concerning a 16 weeks old (also reported as 14 month old by the physician) female patient with no drug reactions or allergies and no pertinent medical history who on unspecified dates were vaccinated with the first dose and second dose "on time" of ROTATEQ, 2 ml orally "twice" (lot number not reported). On unspecified date, the patient was given a dose of ROTARIX in place of the third dose of ROTATEQ. Concomitant therapy included unspecified "oral antibiotics". "Within 10-15 days after getting ROTARIX, the patient was vomiting had diarrhea and watery stools. On unspecified date, the patient was brought to the emergency room of an unspecified hospital where she was given IV fluids (unspecified) and released". At the time of the report, the patient recovered (on unspecified date). The physician reported that the patient had a breakthrough with Rotavirus despite receiving two doses of ROTATEQ and one dose of ROTARIX. Follow up information has been received from a medical assistant concerning 14 month old female patient who on 23-APR-2010 was vaccinated with the first dose of ROTATEQ (lot number: 664076/0768Y) (dose and site of administration not reported), PEDIARIX (lot number: AC21B024AA), ACTHIB (lot number: UH01944) and PREVNAR (lot number: D88184). On 25-JUN-2011, the patient was vaccinated with the second dose of ROTATEQ, 2 mL orally (lot number: 664945/0147Z), PEDIARIX (lot number: AC21B248CA), ACTHIB (lot number: UH091AA) and PREVNAR (lot number: E60221). On 27-AUG-2010, the patient was vaccinated with a dose of ROTARIX (AU1FB058A) in place of third dose of ROTATEQ. On the same day, the patient was also vaccinated with the third dose of PEDIARIX (lot number: AC2B248CA), ACTHIB (lot number: UH093AA) and PREVNAR (lot number: 914265). On 15-MAY-2011, the patient had vomiting and watery stool. On 18-MAY-2011, the patient was seen by the physician. The patient's stools test positive for rotavirus. The patient was taken to hospital and not admitted. The patient was observed in the hospital and was given IV fluid for hydratation. At the time of the report, the patient had recovered from rotavirus. 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 physician concerning an unknown number of patients who on unknown dates were orally vaccinated with 2 mL of the first dose of ROTATEQ (Lot # and expiration not reported) at 14 weeks of age. No adverse effects were reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
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 unknown number of patients who on unknown dates, might had been vaccinated with a dose of ROTATEQ at a longer interval than indicted, (routes and lot numbers not reported). It was unknown if the patients sought medical attention. No adverse effect reported. Follow up information has been received via telephone call from the registered nurse who stated that she could not provide any patient identifiers as the patients had been switched from ROTATEQ to a different vaccine. The patient's were switched from ROTATEQ to another vaccine because the parents had a "tough time" getting their child in on time for the ROTATEQ series of vaccinations. Follow up information has been received from the registered nurse who stated that they had not had any adverse reaction or issues of any kind with ROTATEQ to the best of her knowledge. The nurse thought there was some miscommunication during a phone call with a marketing agent. No further information is available.
Age: 0.59
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Gastroenteritis rotavirus, Rotavirus test positive, Vomiting
Clinical narrative: Information has been received from a physician concerning a 7 month old patient who on 06-OCT-2009 was vaccinated with the first dose of ROTATEQ (lot number: 664068/0319Y) (dose and route of administration not reported). On 08-DEC-2009 was vaccinated with the second dose of ROTATEQ (lot number: 664648/1034Y) (dose and route of administration not reported). On 08-MAR-2010 was vaccinated with the third dose of ROTATEQ (lot number: 664779/1439Y) (dose and route of administration not reported). on 15-MAy-2011, the patient was diagnosed with laboratory confirmed rotavirus gastroenteritis. The baby had several office visits but did not require hospitalization and there was no sequelae. At the time of the report, the patient's outcome was unknown. Follow up information has been received from the physician who reported that the 7 month old male patient with no preexisting allergies, birth defects or medical conditions at the morning of 06-OCT-2009, was vaccinated with the first dose of ROTATEQ (lot number: 664068/0319Y) orally. At the morning of 08-DEC-2009, was vaccinated with the second dose of ROTATEQ (lot number: 664648/1034Y) orally. At the morning of 08-MAR-2010, was vaccinated with the third dose of ROTATEQ (lot number: 664779/1439Y) orally. The patient had diarrhea and his sibling too following prior vaccination third dose. There was no illness at the time of vaccination. On 14-MAY-2011, the patient had vomiting and diarrhea episode with rotavirus after adequate vaccination. The patient sought medical attention. Positive rotavirus elisa assay was reported. At the time of the report the patient had recovered. Additional information is not expected.