chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in jaw, Rash, Tooth abscess
Clinical narrative: Pt developed an outbreak of Shingles in the Mandibular nerve distribution after recieving the vaccine.Vaccination date 04/17/2007, Dental cleaning Morining of 04/23/2007, noticed pain 1PM was managed by dentist for root abcess,  Rash on face broke out 4/27 (Friday) Night, Seen by me on 4/30/07 with classic Shingles
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Skin nodule, Swelling
Clinical narrative: right shoulder pain (deltoid) with a nodule, noted swelling under armpit
Age: 3.0
Sex: M
Vaccine: PNC
Symptoms: Body temperature increased, Swelling
Clinical narrative: FIRST DAY - SMALL AMOUNT OF SWELLING AND NO FEVER.  MORE SWELLING ON SECOND DAY. 5/11/07 LARGE AMOUNT OF SWELLING AND 07.7 AXILLARY TEMP.
Age: 1.17
Sex: M
Vaccine: DTAP
Symptoms: Abdominal pain, Blood alkaline phosphatase increased, Blood glucose increased, Blood test, Crying
Clinical narrative: 05052007  Dtap given @ approx. 10:30 a.m..  TC from mom @12:55 p.m. that child has not stopped fussing and crying since they left the health dept.  He has vomited x 3.  He took a short nap, nursed upon awakening, started crying and vomited again.  Child can be heard crying in the background.  Mom says he draws his legs up to his stomach as though his stomach hurts.  Mom has no primary care MD, no crackers, no carobonated beverages, and no Tylenol.  PHN recommended they go to the Emergency Dept.  At ER, they gave IV fluids, antiemetics and then discharged child to home.
Age: 1.17
Sex: M
Vaccine: DTAP
Symptoms: Emotional distress, Urine analysis normal, Vomiting
Clinical narrative: 05052007  Dtap given @ approx. 10:30 a.m..  TC from mom @12:55 p.m. that child has not stopped fussing and crying since they left the health dept.  He has vomited x 3.  He took a short nap, nursed upon awakening, started crying and vomited again.  Child can be heard crying in the background.  Mom says he draws his legs up to his stomach as though his stomach hurts.  Mom has no primary care MD, no crackers, no carobonated beverages, and no Tylenol.  PHN recommended they go to the Emergency Dept.  At ER, they gave IV fluids, antiemetics and then discharged child to home.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC, HEPA, MMRV, PNC
Symptoms: Rash erythematous, Urticaria
Clinical narrative: 12 mos old boy who developed red urticarial type rash within 12 hours of receiving PCV #3, Hep A #1 (havrix) and MMR/Varicella (proquad).  he went to the er where the rash went away within a few hours of receiving oral benedryl.  he finished 5 days of prednisilone. Information was received froma physician concerning a 12 month old hispanic male, with no known medical history of allergies, who was vaccinated on 12-APR-2007 with a 0.5 ml. SC first dose in the "right" of MMR II (+) VARIVAX ( lot # 656309/1393P). Concominant vaccinations administered that day included a fourth dose of PNEUMOVAX 23 ( lot number B066668 also reported B08557141) subcutaneously and a first dose in the left deltoid of hepatitis A virus vaccine inactivated (havrix) (lot number AHAVE143HA). There was no illness at the time of vaccination. It was reported that within 24 hours the patient developed urticaria. The patient was treated with BENARDRYL. The symptoms have since resolved. It was reported that the patient's medical status is recovering. No product quality was involved. Additional information was received from the doctro who reported that on 12-APR-2007, a red rash developed within 12-24 hours. The patient went to the emergency department and received oral BENADRYL and the rash got better. He was started on oral BENADRYL and prednisone and the rash resolved within a few hours. There was no reoccurance. The patient recovered on 13-APR-2007. No further information is expected.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC, HEPA, MMRV, PNC
Symptoms: Urticaria
Clinical narrative: 12 mos old boy who developed red urticarial type rash within 12 hours of receiving PCV #3, Hep A #1 (havrix) and MMR/Varicella (proquad).  he went to the er where the rash went away within a few hours of receiving oral benedryl.  he finished 5 days of prednisilone. Information was received froma physician concerning a 12 month old hispanic male, with no known medical history of allergies, who was vaccinated on 12-APR-2007 with a 0.5 ml. SC first dose in the "right" of MMR II (+) VARIVAX ( lot # 656309/1393P). Concominant vaccinations administered that day included a fourth dose of PNEUMOVAX 23 ( lot number B066668 also reported B08557141) subcutaneously and a first dose in the left deltoid of hepatitis A virus vaccine inactivated (havrix) (lot number AHAVE143HA). There was no illness at the time of vaccination. It was reported that within 24 hours the patient developed urticaria. The patient was treated with BENARDRYL. The symptoms have since resolved. It was reported that the patient's medical status is recovering. No product quality was involved. Additional information was received from the doctro who reported that on 12-APR-2007, a red rash developed within 12-24 hours. The patient went to the emergency department and received oral BENADRYL and the rash got better. He was started on oral BENADRYL and prednisone and the rash resolved within a few hours. There was no reoccurance. The patient recovered on 13-APR-2007. No further information is expected.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Intussusception, Medication error, Wrong drug administered
Clinical narrative: See the vaccine history attached.   8 month old baby diagnosed with intussuscetion on April 11, 2007 had third rotavirus vax on March 15. DTaP-HBV-POL (Diphtheria, Tetanus, acellular Pertussis, Hepatitis B, Polio) 3/15/2007, 1/2/2007, 10/31/2006  HBV adult (Hepatitis B) 9/1/2006  HIB PRP-OMP (Haemophilus influenzae b) 1/2/2007, 10/31/2006  PNUcn (Pneumococcal conjugate, pneumonia) 3/15/2007, 1/2/2007, 10/31/2006  ROT5 (Rotavirus live, pentavalent) 3/15/2007, 1/2/2007, 10/31/2006 6/26/07 Received hosp med recs which reveal on 4/10/07 pt experienced abdominal pain & wretching & seen in peds clinic.  Referred to ER for w/u.  Surg consult done. Pt d/c to home to be eval by PCP next day. FINAL DX: None provided, surgeon did not feel probable IS. 6/29/07 Received additional hospital medical records which reveal patient admitted 4/11-4/12/07 for continued fever, vomiting, irritability & abdominal pain.  Found to have heme (+) stool in ER.  Per MD notes, IS was reduced by barium enema but no radiology report included. FINAL DX: Intussusception, reduced by barium enema. 7/31/07 Received vax record from reporter.  VAERS database updated w/same.
Age: 21.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Rash pruritic, Urticaria
Clinical narrative: 5/7/07-Patient complained of pruritic raised rash on trunk, back, legs and arms. Better on 5/8/07. 5/9/07 -hives again on face and hands now. Symptoms were treated with Benadryl, with complete resolution on 5/11/07.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Anaemia, Biopsy bone marrow, Blood immunoglobulin A, Blood immunoglobulin E, Blood immunoglobulin G normal
Clinical narrative: Diarrhea and fever (102) x 1 week s/p vaccine (2 month imms).  -anemia -thrombocytopenia -hypoalbuminemia (severe 1.2) -hepatomegaly, -sm hypopigmented papules on forehead and abd (about 8).  6/8/07 Received medical records from hospital which reveal patient experienced fever, nasal congestion, decreased appetite, diarrhea & post tussive vomiting since receiving vax on 4/30/07.  Found to have thrush, congestion, anemia, thrombocytopenia & hepatomegaly in ER.  Admitted 5/7-5/19/07.  Consults by Heme/onc,  Rheumatology, dermatology, ID, GI.  Received multiple transfusions of PRBCs & platelets.  Improved slowly & d/c to home w/PICC line & home health nursing. LABS: bone marrow biopsy 5/10.  Admit H/H 6.0/18.3.  Final H/H 7.3/21.6.  Parvovirus IgG elevated 1.1.  EBNA elevated 1.59  FINAL DX: juvenile xanthogranuloma/ss 6/22/07 Received med recs from provider which included vax rec that confirmed RO lot & dose as reported.  Only health problem noted was mild torticollis on day of vax 4/30/07.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood immunoglobulin M, Blood triglycerides normal, Coagulation test normal, Diarrhoea, Epstein-Barr virus antibody negative
Clinical narrative: Diarrhea and fever (102) x 1 week s/p vaccine (2 month imms).  -anemia -thrombocytopenia -hypoalbuminemia (severe 1.2) -hepatomegaly, -sm hypopigmented papules on forehead and abd (about 8).  6/8/07 Received medical records from hospital which reveal patient experienced fever, nasal congestion, decreased appetite, diarrhea & post tussive vomiting since receiving vax on 4/30/07.  Found to have thrush, congestion, anemia, thrombocytopenia & hepatomegaly in ER.  Admitted 5/7-5/19/07.  Consults by Heme/onc,  Rheumatology, dermatology, ID, GI.  Received multiple transfusions of PRBCs & platelets.  Improved slowly & d/c to home w/PICC line & home health nursing. LABS: bone marrow biopsy 5/10.  Admit H/H 6.0/18.3.  Final H/H 7.3/21.6.  Parvovirus IgG elevated 1.1.  EBNA elevated 1.59  FINAL DX: juvenile xanthogranuloma/ss 6/22/07 Received med recs from provider which included vax rec that confirmed RO lot & dose as reported.  Only health problem noted was mild torticollis on day of vax 4/30/07.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: HIV test negative, Hepatomegaly, Hypoalbuminaemia, Liver function test normal, Parvovirus B19 serology negative
Clinical narrative: Diarrhea and fever (102) x 1 week s/p vaccine (2 month imms).  -anemia -thrombocytopenia -hypoalbuminemia (severe 1.2) -hepatomegaly, -sm hypopigmented papules on forehead and abd (about 8).  6/8/07 Received medical records from hospital which reveal patient experienced fever, nasal congestion, decreased appetite, diarrhea & post tussive vomiting since receiving vax on 4/30/07.  Found to have thrush, congestion, anemia, thrombocytopenia & hepatomegaly in ER.  Admitted 5/7-5/19/07.  Consults by Heme/onc,  Rheumatology, dermatology, ID, GI.  Received multiple transfusions of PRBCs & platelets.  Improved slowly & d/c to home w/PICC line & home health nursing. LABS: bone marrow biopsy 5/10.  Admit H/H 6.0/18.3.  Final H/H 7.3/21.6.  Parvovirus IgG elevated 1.1.  EBNA elevated 1.59  FINAL DX: juvenile xanthogranuloma/ss 6/22/07 Received med recs from provider which included vax rec that confirmed RO lot & dose as reported.  Only health problem noted was mild torticollis on day of vax 4/30/07.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia, Rash papular, Rotavirus test negative, Skin hypopigmentation, Syphilis test negative
Clinical narrative: Diarrhea and fever (102) x 1 week s/p vaccine (2 month imms).  -anemia -thrombocytopenia -hypoalbuminemia (severe 1.2) -hepatomegaly, -sm hypopigmented papules on forehead and abd (about 8).  6/8/07 Received medical records from hospital which reveal patient experienced fever, nasal congestion, decreased appetite, diarrhea & post tussive vomiting since receiving vax on 4/30/07.  Found to have thrush, congestion, anemia, thrombocytopenia & hepatomegaly in ER.  Admitted 5/7-5/19/07.  Consults by Heme/onc,  Rheumatology, dermatology, ID, GI.  Received multiple transfusions of PRBCs & platelets.  Improved slowly & d/c to home w/PICC line & home health nursing. LABS: bone marrow biopsy 5/10.  Admit H/H 6.0/18.3.  Final H/H 7.3/21.6.  Parvovirus IgG elevated 1.1.  EBNA elevated 1.59  FINAL DX: juvenile xanthogranuloma/ss 6/22/07 Received med recs from provider which included vax rec that confirmed RO lot & dose as reported.  Only health problem noted was mild torticollis on day of vax 4/30/07.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Thrombocytopenia, Ultrasound scan abnormal, Ureteric dilatation, Urine protein/creatinine ratio normal, White blood cell count
Clinical narrative: Diarrhea and fever (102) x 1 week s/p vaccine (2 month imms).  -anemia -thrombocytopenia -hypoalbuminemia (severe 1.2) -hepatomegaly, -sm hypopigmented papules on forehead and abd (about 8).  6/8/07 Received medical records from hospital which reveal patient experienced fever, nasal congestion, decreased appetite, diarrhea & post tussive vomiting since receiving vax on 4/30/07.  Found to have thrush, congestion, anemia, thrombocytopenia & hepatomegaly in ER.  Admitted 5/7-5/19/07.  Consults by Heme/onc,  Rheumatology, dermatology, ID, GI.  Received multiple transfusions of PRBCs & platelets.  Improved slowly & d/c to home w/PICC line & home health nursing. LABS: bone marrow biopsy 5/10.  Admit H/H 6.0/18.3.  Final H/H 7.3/21.6.  Parvovirus IgG elevated 1.1.  EBNA elevated 1.59  FINAL DX: juvenile xanthogranuloma/ss 6/22/07 Received med recs from provider which included vax rec that confirmed RO lot & dose as reported.  Only health problem noted was mild torticollis on day of vax 4/30/07.
Age: 73.0
Sex: F
Vaccine: TD, TD
Symptoms: Hypoaesthesia, Injection site pain, Muscle twitching, Oedema peripheral, Pain in extremity
Clinical narrative: 74 Year old female seen and given a tetanus immunization on 8/24/06 on left deltoid cane in to report on 11/28/06 that two weeks after her shot she developed muscle twitching, numbness, dysthesia, swelling and sharp pain left upper extremity never had this in the past. 05/29/07-records received for DOS 10/31-11/2/07-DX: Complex regional pain syndrome. Reflex sympathetic dystrophy.  C/O 5 days worsening edema and pain in left arm triggered by an injection. Noted to have hyperalgesia and allodynia.
Age: 73.0
Sex: F
Vaccine: TD, TD
Symptoms: Arthritis, Bacterial infection, Breath sounds abnormal, Muscle atrophy, Pain
Clinical narrative: 74 Year old female seen and given a tetanus immunization on 8/24/06 on left deltoid cane in to report on 11/28/06 that two weeks after her shot she developed muscle twitching, numbness, dysthesia, swelling and sharp pain left upper extremity never had this in the past. 05/29/07-records received for DOS 10/31-11/2/07-DX: Complex regional pain syndrome. Reflex sympathetic dystrophy.  C/O 5 days worsening edema and pain in left arm triggered by an injection. Noted to have hyperalgesia and allodynia.
Age: 73.0
Sex: F
Vaccine: TD, TD
Symptoms: Swelling
Clinical narrative: 74 Year old female seen and given a tetanus immunization on 8/24/06 on left deltoid cane in to report on 11/28/06 that two weeks after her shot she developed muscle twitching, numbness, dysthesia, swelling and sharp pain left upper extremity never had this in the past. 05/29/07-records received for DOS 10/31-11/2/07-DX: Complex regional pain syndrome. Reflex sympathetic dystrophy.  C/O 5 days worsening edema and pain in left arm triggered by an injection. Noted to have hyperalgesia and allodynia.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Injection site papule, Rash vesicular
Clinical narrative: Papule developed at site of vaccine-1-2 weeks after injection. Papule persists. Clusters of vesicles noted to left of sternum in axilla, to left of spine in derrmatomal pattern-5/13/07. No history of wild varicella prior to immunization. ? vaccine related zoster.
Age: 13.0
Sex: M
Vaccine: HEPA, IPV, MMR, TDAP
Symptoms: Cough, Dizziness, Feeling hot, Foreign body aspiration, Hyperhidrosis
Clinical narrative: Patient suddenly felt hot, sweaty, nauseous, was lightheaded. Was coughing a lot. Rested in cool place, then felt better. Was seen to have tremor at that time, but not witnessed on exam. Improved within about 2 hours. Vaccine sites normal. Suspected diagnosis: FB aspiration (phlegm), cleared.
Age: 13.0
Sex: M
Vaccine: HEPA, IPV, MMR, TDAP
Symptoms: Increased upper airway secretion, Nausea, Tremor
Clinical narrative: Patient suddenly felt hot, sweaty, nauseous, was lightheaded. Was coughing a lot. Rested in cool place, then felt better. Was seen to have tremor at that time, but not witnessed on exam. Improved within about 2 hours. Vaccine sites normal. Suspected diagnosis: FB aspiration (phlegm), cleared.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Swelling
Clinical narrative: None - informed mother to look for localized swelling or redness, and to call back of symptoms continue or worsen
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: PT received adult dose of Havrix (1 ml) instead of Havrix (0.5 ml). No symptoms or signs have developed or been reported by patients guardian.
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Cyanosis, Injection site pruritus, Injection site rash
Clinical narrative: On 8 May 07 I received my second anthrax shot. On 11 May 07 around 2000. The area where I received the shots started to turn blue and began to itch. Everyday after 11 May 07 the itch got worst. On 18 May 07 a rash appeared. and everyday after that the rash spreaded, and the itch got worst.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling
Clinical narrative: Staff noticed swelling in arm where varicella was given per staff, swelling is size of adult size fist. Child discontinued before seen in clinic. Staff noticed 5/13.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Nausea, Skin warm, Vomiting
Clinical narrative: 1/2 -1 hour after vaccination - started to feel very warm. 1.1/2 hours after the vaccine, started to feel nausea. left work 2.1/2 hours after vaccine felt very nauseated and vomited. symptoms then started to subside - but slight headache started.
Age: 0.04
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site bruising, Pyrexia
Clinical narrative: Fever of 102.3 since 4:30 pm 5-16-07, 101.6 5-16-07. Bruising at site of injections.
Age: 0.16
Sex: M
Vaccine: RV5
Symptoms: Choking, Cough
Clinical narrative: Information has been received from a health professional concerning an approximately 2 month old male who, between 09-APR-2007 and 13-APR-2007, was vaccinated with a 2 ml, oral, first dose of rotavirus vaccine live (human-bovine) (lot# 656186/1235F). There was no illness at the time of vaccination. It was reported that the patient appeared to have a hard time swallowing the medication. The reporter felt that the vaccine was too thin and she was uncomfortable with the fact that the patient appeared to cough as a result of the administration. It was reported that the vaccine was administered very slowly and despite that the patient still choked. The patient recovered after the administration of rotavirus vaccine live (human-bovine). There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information is not expected.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 4-month-old female who on 28-MAR-2007 was vaccinated PO with the second dose of rotavirus vaccine live (human-bovine). On 29-MAR-2007, the patient developed diarrhea. On 31-MAR-2007, the patient was seen by the physician as she was still experiencing diarrhea. At the time of this report, the final outcome was unknown. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, Overdose, Vomiting
Clinical narrative: Information has been received from a physician concerning a 2-month-old patient who was vaccinated PO with the first dose of rotavirus vaccine live (human-bovine). The physician reported that the patient threw up after the vaccine was administered and the nurse administered a second dose right away. At the time of this report, the outcome was unknown. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 5/14/2007.  Information has been received from a physician and a healthcare professional concerning a 17-week-old Hispanic female with no medical history who on 22-MAR-2007 was vaccinated PO with the first dose of ROTATEQ (Lot #656101/1231F).  There was no illness at the time of vaccination.  At approximately 11:00, immediately after being vaccinated on 22-MAR-2007, the patient threw up/vomited.  The nurse administered a second dose right away.  No laboratory/diagnostic tests were performed.  At the time of this report, the outcome was unknown.  Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5, DTAP, HIBV, IPV, RV5
Symptoms: Diarrhoea, Gastroenteritis rotavirus, Rotavirus test negative, Rotavirus test positive, Stool analysis abnormal
Clinical narrative: Information has been received from a physician concerning a two month old male who on 09-MAR-2007 was vaccinated with rotavirus vaccine live (human-bovine) PO first dose. Concomitant therapy included "two month old required vaccinations". The physician reported that the patient who received the vaccine on 09-MAR-2007 had vomited and was experiencing prolonged diarrhea by 15-MAR-2007. The patient was also experiencing weight loss due to the vomiting and prolonged diarrhea. The physician reported that they obtained three stool samples from the patient on 21-MAR-2007 the stool sample tested negative for rota virus. On 27 and 31-MAR-2007 the stool samples tested positive for rota virus. The physician reported that after the positive rota virus tests, the mother was advised to stop breast feeding the patient and recommended the patient be seen by a GT specialist. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5, DTAP, HIBV, IPV, RV5
Symptoms: Stool analysis normal, Vomiting, Weight decreased
Clinical narrative: Information has been received from a physician concerning a two month old male who on 09-MAR-2007 was vaccinated with rotavirus vaccine live (human-bovine) PO first dose. Concomitant therapy included "two month old required vaccinations". The physician reported that the patient who received the vaccine on 09-MAR-2007 had vomited and was experiencing prolonged diarrhea by 15-MAR-2007. The patient was also experiencing weight loss due to the vomiting and prolonged diarrhea. The physician reported that they obtained three stool samples from the patient on 21-MAR-2007 the stool sample tested negative for rota virus. On 27 and 31-MAR-2007 the stool samples tested positive for rota virus. The physician reported that after the positive rota virus tests, the mother was advised to stop breast feeding the patient and recommended the patient be seen by a GT specialist. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5, DTAP, HIBV, IPV, RV5
Symptoms: Diarrhoea, Faeces discoloured, Full blood count, Rotavirus test positive, Saliva analysis normal
Clinical narrative: Information has been received from a physician concerning a two month old male who on 09-MAR-2007 was vaccinated with rotavirus vaccine live (human-bovine) PO first dose. Concomitant therapy included "two month old required vaccinations". The physician reported that the patient who received the vaccine on 09-MAR-2007 had vomited and was experiencing prolonged diarrhea by 15-MAR-2007. The patient was also experiencing weight loss due to the vomiting and prolonged diarrhea. The physician reported that they obtained three stool samples from the patient on 21-MAR-2007 the stool sample tested negative for rota virus. On 27 and 31-MAR-2007 the stool samples tested positive for rota virus. The physician reported that after the positive rota virus tests, the mother was advised to stop breast feeding the patient and recommended the patient be seen by a GT specialist. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5, DTAP, HIBV, IPV, RV5
Symptoms: Stool analysis normal, Sweat chloride test normal, Vomiting, Weight decreased
Clinical narrative: Information has been received from a physician concerning a two month old male who on 09-MAR-2007 was vaccinated with rotavirus vaccine live (human-bovine) PO first dose. Concomitant therapy included "two month old required vaccinations". The physician reported that the patient who received the vaccine on 09-MAR-2007 had vomited and was experiencing prolonged diarrhea by 15-MAR-2007. The patient was also experiencing weight loss due to the vomiting and prolonged diarrhea. The physician reported that they obtained three stool samples from the patient on 21-MAR-2007 the stool sample tested negative for rota virus. On 27 and 31-MAR-2007 the stool samples tested positive for rota virus. The physician reported that after the positive rota virus tests, the mother was advised to stop breast feeding the patient and recommended the patient be seen by a GT specialist. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 3 month old male who on 04-MAR-2007 was vaccinated with rotavirus vaccine live (human-bovine). In 2007 the patient experienced four loose stools a day. The physician stated that the stools did not contain blood and did not have a foul odor. The patient sought unspecified medical attention. The patient's four loose stools a day persisted. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: RV5
Symptoms: Crying, Infantile spitting up, Regurgitation, Underdose
Clinical narrative: Information has been received from a medical assistant concerning a 4-month-old male who on 06-APR-2007 was vaccinated PO with a 2mL dose of rotavirus vaccine (human-bovine). Subsequently the patient spit up some of the rotavirus vaccine (human-bovine) 5 minutes after it was administered. The reporter believed he spit it up because he was crying and upset because other vaccines were being given. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 0.6
Sex: U
Vaccine: RV5
Symptoms: Dermatitis diaper
Clinical narrative: Information has been received from a physician concerning a 6-month-old patient who was vaccinated PO with a third dose of rotavirus vaccine (human-bovine). Concomitant therapy included other unspecified 6 month vaccinations. Subsequently, one day after vaccination, the patient experienced diaper rash. The patient was given unspecified antibiotics. The outcome was recovering. Unspecified medical attention was sought. No other information was reported. There were no lab diagnostic studies performed. There was no product quality complaint. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 17 week patient who on 30-MAR-2007 was vaccinated with a second dose of ROTATEQ Lot # 656102/1165F). On 06-APR-2007, the patient was vaccinated with the third dose of oral ROTATEQ (lot # 656302/1165F). No further information was available.
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a physician concerning a 4-month-old birth twin who on 09-FEB-2007, 30-MAR-2007 and 06-APR-2007 was vaccinated with the first, second and third doses respectively, of rotavirus vaccine. It is unknown if medical attention was sought. No symptoms were noted. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Pseudomonas infection, Sepsis
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated at 4-month-old with a dose of rotavirus vaccine (human-bovine). Subsequently the patient experienced pseudomonas sepsis. The physician did not feel that the rotavirus vaccine (human-bovine) caused the infection. Additional information has been requested.
Sex: U
Vaccine: RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Blood culture positive, Compartment syndrome, Diarrhoea, Erythema, Fasciotomy
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated at 4-month-old with a dose of rotavirus vaccine (human-bovine). Subsequently the patient experienced pseudomonas sepsis. The physician did not feel that the rotavirus vaccine (human-bovine) caused the infection. Additional information has been requested.
Sex: U
Vaccine: RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Fluid replacement, Gangrene, Hypotension, Immunology test, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated at 4-month-old with a dose of rotavirus vaccine (human-bovine). Subsequently the patient experienced pseudomonas sepsis. The physician did not feel that the rotavirus vaccine (human-bovine) caused the infection. Additional information has been requested.
Sex: U
Vaccine: RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Induration, Intubation, Oxygen supplementation, Pseudomonal sepsis, Pseudomonas infection
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated at 4-month-old with a dose of rotavirus vaccine (human-bovine). Subsequently the patient experienced pseudomonas sepsis. The physician did not feel that the rotavirus vaccine (human-bovine) caused the infection. Additional information has been requested.
Sex: U
Vaccine: RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Purpura, Pyrexia, Respiratory distress, Septic shock, Skin graft
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated at 4-month-old with a dose of rotavirus vaccine (human-bovine). Subsequently the patient experienced pseudomonas sepsis. The physician did not feel that the rotavirus vaccine (human-bovine) caused the infection. Additional information has been requested.
Sex: U
Vaccine: RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Skin lesion, Surgery, Upper respiratory tract infection
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated at 4-month-old with a dose of rotavirus vaccine (human-bovine). Subsequently the patient experienced pseudomonas sepsis. The physician did not feel that the rotavirus vaccine (human-bovine) caused the infection. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Agitation, Ear disorder, Otitis media acute, Sleep disorder
Clinical narrative: Information has been received from a physician concerning a 2 month old white female with viral congestion and no fever who on 27-DEC-2006 was vaccinated with rotavirus vaccine (human-bovine) 1 cc PO as a first time dose (Lot # 655405/1113F). The nurse reported the infant of a diabetic mother had some nasal congestion at the time of immunization but no fevers at the time of immunization. On 04-JAN-2007 the patient returned to the clinic with a three day history of not sleeping, fussiness and batting at her ears (onset 01-JAN-2006). The nurse reported the infant was diagnosed with left acute otitis media and was treated with good resolution. The nurse noted that the patient did not develop otitis media after her four month immunization. The infant recovered on 10-JAN-2007. Additional information has been requested.
Age: 0.6
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a physician concerning a 6 month old patient who in December 2006, was vaccinated with rotavirus vaccine (human-bovine) (2 nd dose). The patient received her second dose four months after she had received her first dose of rotavirus vaccine (human-bovine). No problems were reported. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a medical assistant (MA) concerning a 14-15 week old patient who was vaccinated with the first dose of rotavirus vaccine (human-bovine). It was unknown if medical attention was sought. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Fluid replacement, Frequent bowel movements
Clinical narrative: Information has been received from a physician concerning a 2 month old male who was vaccinated with Rotateq. In March 2007 (last month), the patient experienced 10 to 12 bowel movements a day with severe diarrhea 5 days after the vaccine was given. The 10 to 12 bowel movements with severe diarrheas lasted for 12 days. Subsequently, the patient recovered from the 10 to 12 bowel movements a day with severe diarrhea two weeks after the vaccination was given. Ten to 12 bowel movements a day with severe diarrhea was considered to be disabling and an other important medical event. Unspecified medical attention was sought and the patient was hydrated with oral fluids. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: RV5
Symptoms: Mouth injury
Clinical narrative: Information has been received from a registered nurse concerning a 4 month old male who was vaccinated with an oral 2 mL first dose of rotavirus vaccine (human-bovine). Concomitant vaccination included "standard 4 month old vaccines". While the patient was being vaccinated he bit down on the vial. The patient cut his lip or mouth "a little" while receiving the vaccine and started to bleed a little due to "the hard plastic nature of the vaccine vial". The nurse reported that the patient "could very well have been teething" and the reason for the reason why he bit down on the vial. No lot number was provided. It was reported that the patient "was fine now". A product quality complaint was resolved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with the first dose of rotavirus vaccine (human-bovine). The patient subsequently developed 10 days of watery diarrhea. Unspecified medical attention was sought. The patient recovered. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Vomiting projectile
Clinical narrative: Information has been received from a certified medical assistant (CMA) concerning a 9-week-old breast fed white female who on 12-APR-2007 was vaccinated PO with the first dose of rotavirus vaccine (human-bovine) (lot # 655406/1114F). On 12-APR-2007, the patient experienced projectile vomiting when "a little" of the vaccine was administered into her mouth. The CMA tried again to administer the dose and the patient vomited again. The dose was then mixed with Pedialyte, but the patient vomited again. Unspecified medical attention was sought. On that same day, the patient recovered. No further information is available.
Sex: M
Vaccine: PNC, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse (RN) concerning a patient who was vaccinated with the first dose of rotavirus vaccine (human-bovine) after 12 weeks of age. It was unknown if medical attention was sought. No adverse event was reported. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Gastroenteritis rotavirus, Rotavirus test positive, Stool analysis abnormal
Clinical narrative: Information has been received from a licensed practical nurse concerning a 21 week old female who was vaccinated with a first and second oral dose of rotavirus vaccine (human-bovine) on 20-DEC-2006 (lot # 655174/0848F) and 21-FEB-2007 (lot # 656188/1238F), respectively. There was no adverse event after the first dose. On 20-MAR-2007 the patient developed multiple episodes of diarrhea which was confirmed to be rotavirus. A stool test was done. Unspecified medical attention was sought. At the time of the report the patient was recovering. There was no product quality complaint involved. Further information has been received from the nurse concerning this five ) HlB conj vaccine (OMPC) ( lot # 655079/1435F) on 21-FEB-2007. On 19-MAR-2007 the diarrhea was foul smell and a stool specimen was sent. On 29-MAR-2007 the stool sample came back positive for Rotavirus. IT was reported that the patient had recovered on an unspecifed date.month old female with no known allergies or medical conditions and no illness at the time of vaccination who on 21-FEB-2007 was vaccinated with the second dose of oral dose ROTATEQ in combination with diphtheria toxoid (+) hepatitis B virus vaccine rHBaAg (yeast) (+) pertusis acellular 3-componenet vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid PEDIARIX . Further information is not expected.
Age: 0.6
Sex: M
Vaccine: RV5
Symptoms: Gastroenteritis rotavirus
Clinical narrative: Information has been received from a consumer concerning his 6 month old son who was vaccinated PO with a dose of rotavirus vaccine (human-bovine). Concomitant therapy included dextrose (+) electrolytes (unspecified) (PEDIALYTE SOLUTION). The patient was also receiving fluids. The patient subsequently developed rotavirus. Unspecified medical attention was sought. At the time of this report, the patient's rotavirus persisted. No further information is available.
Sex: U
Vaccine: RV5
Symptoms: Gastroenteritis rotavirus
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated PO with the first dose of rotavirus vaccine (human-bovine). The patient subsequently developed rotavirus gastroenteritis. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. This is one of several reports received from the same source. 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 and a nurse concerning an approximately 16 week female with a history of colostomy who on 12-FEB-2007 was the first dose of vaccinated with rotavirus vaccine (human-bovine) by mouth. There was no concomitant  medication. On approximately 26-MAR-2007 (two to three weeks ago), the patient was positive for rotavirus at a visit to the emergency room for diarrhea. It was reported that per labs in the emergency room the patient was positive for rotavirus. Subsequently, the patient recovered from positive for rotavirus. The physician mentioned that the patient's mother thought the child spit up the dose of rotavirus vaccine (human-bovine) at the time of administration. The nurse's notes did not indicate that the child spit up the doe. Additional information has been requested. This is in follow-up to reports previously submitted on 5/14/2007. Information has been received from a physician and a nurse concerning an approximately 15 week female who was born with imperforate anus and had a colostomy who on 12-FEB-2007 was vaccinated with the second dose of oral ROTATEQ (Lot #655485/1033F). There were no concomtitant medications. On approximately 26-MAR-2007 (two to three weeks ago) also rported as March 2007, the patient was positive for rotavirus  at a visit to the emergency room for diarrhea. The patient developed diarrhea about one month after receiving the first rotavirus vaccine. It was reported that pel labs in the emergency room the patient was positive for rotavirus. Subsequently, the patient recovered from positive for rotavirus after a few days. The physician mentioned that the patient's mother thought the child spit up the dose of ROTATEQ at the time of administration. The nurse's did not indicate that the child spit up the dose. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 4 month old patient who was vaccinated PO with a first dose of Rotateq. No further information was provided.  There was no product quality complaint. Additional information has been requested.
Age: 0.15
Sex: M
Vaccine: DTAPHEPBIP, DTPHIB, PNC, RV5
Symptoms: Crying, Irritability
Clinical narrative: This is in follow-up to report (s) previously submitted on 5/14/2007. Information has been received from a physician concerning a 2-6 month old patient who was vaccinated with a first dose of Rotateq. Concomitant vaccines administered on that same day included "other vaccines". The patient subsequently became irritable. Unspecified medical attention was sought. The patient's symptoms subsequently resolved on their own after a short period of time. It was unknown if the patient completed the series.  This is one of several reports received from same source.  Additional information has been requested. Information has been received from a physician concerning a 55 day old male who on 19-DEC-2006 was vaccinated PO with the first dose of ROTATEQ (Lot # 655082/0779F). Concomitant vaccinations administered on that day included the first IM dose in the left thigh of PEDIARIX (Lot #AC21B073AA), the first IM dose in the right thigh of ACTHIB (Lot # UE994AA) and the first IM dose in the right thigh of PREVNAR (Lot #B08646P). The physician reported that on 19-DEC-2006, the patient became irritable and had prolonged high-ptiched crying for several hours post-vaccination. Unspecified medical attention was sought. The patient's symptoms subsequently resolved on their won after a short period of time. On 27-FEB-2007 the patient was vaccinated PO with the second dose ROTATEQ (Lot #656188/1238F). Concomitant vaccinations administered on that same day included teh second IM dose in the left thigh PEDIARIX (Lot #C2569AA), the second IM dose in the right thigh ofACTHIB (Lot #UF929AA), the second IM dose in the right thigh of PREVNAR (Lot #B08684C) and the second IM dose in the left thigh of IPOL (Vero) (Lot #Z0324). The physician reported that on 27-FEB-2007, patient became irritable and had prolonged high-pitched crying for several hours post-vaccination. Unspecified medical attention was sought. The patient;s symtoms subsequently resolved on their own after a short period of time. It was unknown if the patient completed the series of ROTATEQ. This is one of several reports received from the same souce.Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Gastroenteritis rotavirus
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated PO with a 2.0 mL dose of Rotateq. The patient possibly developed rotavirus. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Breast feeding, Crying, Vomiting projectile
Clinical narrative: Information has been received from a physician concerning a 2 month old patient with no pertinent medical history or allergies, who on 08 Feb 2007 was vaccinated with Rotateq, "one tube" by mouth (lot # 654663/0942F). There was no concomitant medication. About six hours post vaccination, on 08 Feb 2007, the patient developed projectile vomiting and fits of crying that lasted two days. There were no other symptoms. The baby was on breast milk only. The patient sought unspecified medical attention. On 10 Feb 2007, the patient recovered from projectile vomiting and fits of crying. Additional information has been requested. It was also reported that the patient had no adverse events after two more doses of ROTATEQ. No further information is expected.
Age: 0.1
Sex: M
Vaccine: RV5, UNK
Symptoms: Screaming
Clinical narrative: Information has been received from a pharmacist concerning her son with no pertinent medical history and no drug reactions/allergies who in February 2007, was vaccinated PO with a dose of Rotateq. Concomitant therapy that day included 4 other unspecified vaccines. Subsequently, 2-3 hours after vaccination, the patient was screaming and pulling on his leg. This occurred for a couple of hours. The pharmacist did not call the pediatrician. By the next day, her son was " a lot better". The patient recovered. The pharmacist mentioned that her son was breastfed exclusively during the time of vaccination. No further information was available. There were no lab diagnostic studies performed.  There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal pain, Agitation, Body temperature decreased, Body temperature increased, Crying
Clinical narrative: Information has been received from a physician concerning a Caucasian female patient (previously reported as 4 month old) with an unknown medical history and no known allergies who on 17 Apr 2007 was vaccinated with second oral dose (previously reported as first dose) of Rotateq (Lot # 656195/0025D). There was no illness at the time of vaccination. Concomitant vaccinations on that day included the second dose of PedvaxHIB (lot # 655079/1435F), the second dose of Pediarix (lot # AC1B092AA), and the second dose of Prevnar (lot # B08670E). Within twenty four hours of receiving Rotateq (also reported on 17 Apr 2007), the patient experienced fever of 102, loose stools, bad abdominal cramping. No blood was detected in stool. The patient was also very fussy and decreased appetite. Unspecified medical attention was sought. At the time of the report the patient was recovering. In follow up on 18 Apr 2007, in the early am (9:00am was when the physician was called), the patient had a fever up to 103.5, was fussy, has loose stool, crying unconsolable, poor appetite and everytime she eats a few sips she will start screaming pulling her legs up to her stomach. The patient did not have blood or mucous in her stool and no vomiting. The patient's white blood cell count (WBC) at the patient's mother's family doctor was 3.5. On 19 Apr 2007, the patient was recovering and he patient's temperature was down to 100.5. No further information is expected.
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Decreased appetite, Diarrhoea, Laboratory test normal, Pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a Caucasian female patient (previously reported as 4 month old) with an unknown medical history and no known allergies who on 17 Apr 2007 was vaccinated with second oral dose (previously reported as first dose) of Rotateq (Lot # 656195/0025D). There was no illness at the time of vaccination. Concomitant vaccinations on that day included the second dose of PedvaxHIB (lot # 655079/1435F), the second dose of Pediarix (lot # AC1B092AA), and the second dose of Prevnar (lot # B08670E). Within twenty four hours of receiving Rotateq (also reported on 17 Apr 2007), the patient experienced fever of 102, loose stools, bad abdominal cramping. No blood was detected in stool. The patient was also very fussy and decreased appetite. Unspecified medical attention was sought. At the time of the report the patient was recovering. In follow up on 18 Apr 2007, in the early am (9:00am was when the physician was called), the patient had a fever up to 103.5, was fussy, has loose stool, crying unconsolable, poor appetite and everytime she eats a few sips she will start screaming pulling her legs up to her stomach. The patient did not have blood or mucous in her stool and no vomiting. The patient's white blood cell count (WBC) at the patient's mother's family doctor was 3.5. On 19 Apr 2007, the patient was recovering and he patient's temperature was down to 100.5. No further information is expected.