chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.25
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Rhinorrhoea, Status epilepticus, Strabismus
Clinical narrative: 1st set of shots given on 8-31-06.  No fever or fussiness after shots.  9-6-06 Runny stuffy nose - Rx. Infant Pediacare .4cc given 3 times a day.  9-10-06 Lt arm jerking, fist clenched arm against body Lasted 3 to 4 minutes. Then arm went limp.  Cried only when arm jerking.  Arm remained limp for about 1 hour. No hand grasp at that time.  After 2 hours hand grasp returned and appeared normal.  9-23-06  Lt arm jerking with fist clenched.  Lasted 2 minutes.  Then limpness.  Regained normal range of motion and hand grasp after about 35 minutes.  9-28-06  Had been napping for 20 minutes.  Cried out.  Eyes closed. Lt arm jerking with hand clenched.  Arm close to body.  Lasted 2 minutes and arm again went limp for about 35 minutes.  9-29-06  Seizure began 8:10am.  Began in Rt arm as a tremor then moved into both arms and legs and then her whole body was shaking.  Eyes deviated to the lt.  No vomiting. Discharged on Keppra 70 mg twice a day for 5 days then 100mg twice a day DC DX: Status epilepticus, resolved. Epilepsy vs seizure disorder. Serious infection ruled out. PMH: Three episodes of left elbow to hand jerking three times this month. Jerking lasts two minutes, the arm is really stiff, she cannnot open the fingers and then the arm would go limp. Arm stiffness began ten days afer her 2 month old shots which were approximately three weeks prior to this ER visit. Mother did not make an appointment with neurologists that was recommended on 10/10/06.
Age: 58.0
Sex: M
Vaccine: FLUN3
Symptoms: Medication error
Clinical narrative: 58 year old male administered Flumist live virus vaccine that should not be given to individuals older than 50. Pt educated on influenza symptoms and instructed to report for medical care immediately if symptoms present. Pt stated he is very healthy and will comply.
Age: 38.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal pain, Chills, Cough, Face oedema, Fatigue
Clinical narrative: Abdominal pain, headache, fever, chills, nausea, runny nose, cough, tiredness, facial edema.
Age: 38.0
Sex: F
Vaccine: FLUN3
Symptoms: Headache, Nausea, Pyrexia, Rhinorrhoea
Clinical narrative: Abdominal pain, headache, fever, chills, nausea, runny nose, cough, tiredness, facial edema.
Age: 0.74
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site induration, Injection site mass, Pyrexia
Clinical narrative: 10 days after vaccination developed high fever (above 103) with a hard knot remaining in the leg the Pediarix was given.  Symptoms lasted 5 days.  Saw the doctor, treated with tylenol and motrin.
Age: 1.07
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: High fever 2-3 days after shots
Age: 43.0
Sex: M
Vaccine: FLUN3
Symptoms: Arthralgia, Chills, Dizziness, Pyrexia
Clinical narrative: She received the vaccine on 14 Oct 06 at apporoximatley 1030.  By 1700 she was feeling dizzy and had the chills.  Her temperature at that time was 101.  She had a fever for the next 24 hours and the highest it got was 102.6.  She took ibuprofen to aleviate the fever, but it only helped her joint pain.  She then took Tylenol and her fever came down.
Age: 47.0
Sex: M
Vaccine: MMR
Symptoms: Headache, Lymphadenopathy, Pharyngolaryngeal pain
Clinical narrative: MMR administered on 10/4/06 (not sure if he had an MMR as a child.  On 10/13 he developed an occipital HA that was largely relieved by Advil.  On 10/14, he noted persistent (although less intense) HA & cervical adenopathy that he described as large and tender.  Since then, his HA and adenopathy have improved but are not resolved.   He reports, NKDA, no fever, chills, cough or SOB.  He has a very mild sore throat.  No family contacts are ill.  O: T 98.7, throat clear, slight to moderate cervical and submandibular adenopathy (L>R), lungs clear
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: The nurse noted swelling to the size of an orange at the site where the vaccine was administered ( right upper sub-q area).  The physician assistant was notified and the patient received Ibuprofen 800mg every 8 hours for a localized reaction.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Crying, Injection site erythema, Injection site swelling
Clinical narrative: SWELLING AND REDNESS AT INJECTION SITES WITHIN 2 MINUTES OF INJECTIONS, PLUS SWELLING AND REDNESS CIRCUMSCRIBING BOTH ANKLES.  ALSO UNCONSOLLABLE CRYING THAT DECREASED 15 MINUTES AFTER REACTION.  SWELLING PEAKED 2-3 MINUTES AFTER VACCINE ADMINISTRATION, THEN STARTED DECREASING AROUND THE 5-MIN POST VACCINATION PERIOD.  COMPLETELY RESOLVED SWELLING BY 30 MINUTES BUT NO IMPROVEMENT IN CRYING OTHER THAN DURING FORMULA FEEDING AT 15 MINUTE MARK.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema
Clinical narrative: Redness and erythema to left deltoid area, instructed to use otc Benadryl orally and apply cold compresses until redness and pain subsided, if no better than to RTC.
Age: 1.49
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Patient diagnosed with breakthrough varicella.
Age: 43.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Cellulitis, Eye pain, Headache, Injection site pain
Clinical narrative: Headache, general malaise, cellulitis, eye pain, severe pain at injection site and all of left arm, fever, arthralgia, rash.
Age: 43.0
Sex: M
Vaccine: PPV
Symptoms: Malaise, Pyrexia, Rash
Clinical narrative: Headache, general malaise, cellulitis, eye pain, severe pain at injection site and all of left arm, fever, arthralgia, rash.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Myalgia, Swelling
Clinical narrative: Patient developed soreness and swelling around Right Deltoid muscle with pain on 10/13/06;  erythema developed on 10/15/06.  Patient used Ibuprofen, Tylenol, and an anti-inflammatory cream as treatment.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chills, Cough, Ear discomfort, Eye discharge
Clinical narrative: Received vaccination at 3:30 pm.  At app. 7:00 pm, noticed phlemmy throat, wheezing and coughing.  At app. 2:00 am, had extreme chills and fever of at least 102, headache, body aches, head congestion, plugged left ear, mattery eyes, swollen eyelids, weakness, and was pale and gray.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Eyelid oedema, Headache, Nasal congestion, Pain, Pallor
Clinical narrative: Received vaccination at 3:30 pm.  At app. 7:00 pm, noticed phlemmy throat, wheezing and coughing.  At app. 2:00 am, had extreme chills and fever of at least 102, headache, body aches, head congestion, plugged left ear, mattery eyes, swollen eyelids, weakness, and was pale and gray.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Wheezing
Clinical narrative: Received vaccination at 3:30 pm.  At app. 7:00 pm, noticed phlemmy throat, wheezing and coughing.  At app. 2:00 am, had extreme chills and fever of at least 102, headache, body aches, head congestion, plugged left ear, mattery eyes, swollen eyelids, weakness, and was pale and gray.
Age: 10.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Pain, Swelling
Clinical narrative: Patient received PPV-23 vaccine on 10-10-06 in upper left arm. 10-12-06 patient returned to clinic with complaints of soreness. On exam of upper left arm moderate amounts of induration noted with erythema 5"x3" in size. Patient was seen by medical provider and was presribed, Atarax 25mg 1 tablet po every 6 hours for swelling routine for 48 hours, Motrin 200mg 2 tablets every 6 hours routine for 48 hours. Patient was contacted 10-13-06 and stated "arm is better".
Age: 1.3
Sex: M
Vaccine: DTAP, HEPA, HIBV, VARCEL
Symptoms: Injection site rash, Injection site vesicles, Rash macular
Clinical narrative: Vaccine administered on 9-28-06, seen in the office on 10-09-06 and had a 2x3 macular rash with a 3cm nodule. On 10-16-06, mom called and said pateint had a blistery rash around injection site on 9-13-06 and treated at home with Benadryl and patient is doing well now.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Fever, chills, swelling and redness at site.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dizziness, Dysphonia, Dyspnoea, Heart rate increased
Clinical narrative: Experienced difficulty breathing, severe wheezing, hoarseness, elevated heart rate, dizziness, hives, paleness and weakness.  I went to the emergency room and received 2 steroids, 2 benadryl and a breathing treatment.  Went home with an inhaler and benadryl.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Pallor, Urticaria, Wheezing
Clinical narrative: Experienced difficulty breathing, severe wheezing, hoarseness, elevated heart rate, dizziness, hives, paleness and weakness.  I went to the emergency room and received 2 steroids, 2 benadryl and a breathing treatment.  Went home with an inhaler and benadryl.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chest pain, Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: DIFFICULTY BREATHING, FAST HEART BEAT, DIZZINESS, PALENESS, WEAKNESS, FEVER,BODY ACHES ,VOMITING, CHEST PAIN. HEART BEAT LASTED FOR ABOUT 5 MINUTES, VOMITED 1 TIME, DIFFICULTY BREATHING FOR ABOUT 2 DAYS , DIZZINESS AND WEAKNESS FOR 3 DAYS SO FAR  AND  CHEST PAIN FOR 2 DAYS.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pallor, Pyrexia, Vomiting
Clinical narrative: DIFFICULTY BREATHING, FAST HEART BEAT, DIZZINESS, PALENESS, WEAKNESS, FEVER,BODY ACHES ,VOMITING, CHEST PAIN. HEART BEAT LASTED FOR ABOUT 5 MINUTES, VOMITED 1 TIME, DIFFICULTY BREATHING FOR ABOUT 2 DAYS , DIZZINESS AND WEAKNESS FOR 3 DAYS SO FAR  AND  CHEST PAIN FOR 2 DAYS.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Medication error
Clinical narrative: Information has been received from a licensed practical nurse concerning a 6 month old pa who was vaccinated PO with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine). it was unk if medical attention was sought and no adverse event was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a pt who in Aug 2006, was vaccinated with a first dose of Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine). Within 2 days in Aug 2006, the pt developed vomiting. The vomiting resolved within a week. No subsequent doses of Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine) had been administered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5, UNK
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 2 month old female who on 8/26/06 was vaccinated PO with a 2.0 ml dose of Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine) along with other vaccinations (vaccines unk). The physician reported since 8/26/06 the pt has had seven cases of diarrhea as of 9/5/06. Unspecified medical attention was sought. The pt had no weight loss and was noted to be afebrile. At the time of this report, the pt had not recovered. Additional information has been requested.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 13 week old male who on the morning of 8/17/06 was vaccinated PO with the first dose of Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine). Concomitant vaccinations administered on that same day and time included the first IM dose of Pediarix (lot AC21B059AA), the first IM dose of ActHib (lot UE918AA) and the first IM dose of Prevnar (lot B08682A). It was reported that on the morning of 8/17/06, six hours after being vaccinated, the pt experienced a high fever up to 102-103. The pts temp continued to rise up to 105. Despite being treated with Tylenol and Motrin, the pt went to the ER for evaluation. Blood cultures, urine cultures and a chest x ray were all neg. Subsequently, the pts fever resolved. No further information is available.
Sex: F
Vaccine: RV5
Symptoms: Eye irritation, Medication error
Clinical narrative: Information has been received from a licensed practical nurse concerning a female medical assistant who got Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine) in both of her eyes when a baby spit it out during administration. The LPN reported that subsequently, the medical assistants right eye burned. The medical assistant was treated at the splash station in the office. At the time of the report, the outcome was unk. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Medication error
Clinical narrative: Information has been received from a registered nurse concerning a 6 month old male who was vaccinated with the first dose of Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine) at six months of age and the second dose at 7 months of age. It was unk if medical attention was sought and the pt did not have any symptoms. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Medication error
Clinical narrative: Information has been received from a physicians assistant concerning a 4 month old pt who was vaccinated with a dose of Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine). It was unk if medical attention was sought and no adverse experiences were reported. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a 2 month old pt with a history of an ear infection who on 9/7/06 was vaccinated PO with a 2.0 ml dose of Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine). Concomitant vaccinations administered on that same day included a dose of Pediarix, a dose of Prevnar and a dose of Hib conj vaccine. The physician reported that on 9/7/06, the pt developed a high fever. Unspecified medical attention was sought. At the time of this report, the pt was recovering. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning an 8 week old female who on 9/8/06 was vaccinated with a 2ml oral dose of Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine) (lot 655153/0847F). Concomitant vaccine administered on the same day included a dose of Prevnar, a dose of Dtap, poliovirus vaccine and a dose of Hib/Hep B vaccine. It was reported, that, over the weekend of 9/9/06 to 9/10/06, the pt developed an extensive case of hives on her face, arms, legs, and abdomen and went to the ER. No product quality complaint was involved. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Medication error
Clinical narrative: Information has been received from a health professional concerning a 17 week old pt who was vaccinated with a first dose of Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine). Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning a female who, before three months of age, was vaccinated PO with the first dose of Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine). The physician reported that the pts temp went up to 103.7 after being vaccinated. The physician also reported that, within 36-72 hours of receiving rotavirus, the pt developed diarrhea and vomiting. The pt was taken to the ER where she was treated with IV fluids. It was noted that the pt was hospitalized for an unk length of time and then released. The pt subsequently recovered in approx one week. the physician also considered the pts 103.7 temp, diarrhea and vomiting to be other important medical events (OMIC). Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Breath holding, Retching
Clinical narrative: Information has been received from a physician concerning a 2 month old pt who on 9/8/06 was vaccinated PO with a 2.0 ml dose of Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine) (lot number not provided). The physician reported that on  9/8/06, the pt gagged when rotavirus vaccine was administered causing the child to hold their breath for a brief period of time. Unspecified medical attention was sought. On that same day, the pt recovered from their events. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 2-month-old female who was vaccinated by mouth with a 2.0 ml dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (lot number not provided).  Concomitant vaccinations administered on that same day included a dose of "another vaccine" (not further specified).  The physician reported that the patient subsequently vomited twice.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  Additional information has been requested.
Age: 0.35
Sex: U
Vaccine: RV5
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a registered nurse (RN) concerning an 18-week-old patient who on 26-May-2006 was vaccinated by mouth with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine). It was unknown if medical attention was sought and no symptoms were noted.  Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 2-month-old male who was vaccinated by mouth with a dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine).  The physician reported that, within two weeks of vaccination, the patient developed diarrhea characterized by roughly 6-7 loose stools each day for approximately five days.  Unspecified medical attention was sought. Subsequently, the patient's diarrhea resolved. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Ultrasound scan normal, Vomiting
Clinical narrative: Information has been received from a physician concerning an 8 week old female who was vaccinated with first oral dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine). Four days after the vaccination the patient experienced vomiting and diarrhea.  It was reported that the patient recovered seven days after the vaccination.  Unspecified medical attention was sought.  No product quality complaint was involved.  No other information was provided. Additional information has been requested. 04/04/2010 Follow-up information from a physician indicated that on 01-SEP-2006 the patient experienced vomiting and diarrhea. The patient had a follow-up visit. An ultrasound was done to rule out pyloric stenosis secondary to vomiting and it was normal. The physician reported that the patient continued experiencing vomiting and diarrhea for 12 days from the vaccination. It was reported that the patient recovered on 11-SEP-2006. Additional information is not expected.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Gastroenteritis
Clinical narrative: Information has been received from a physician concerning an approximately 4 month old male who was vaccinated with a 2 ml oral dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). Subsequently the patient experienced gastroenteritis and diarrhea. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Medication error
Clinical narrative: Information has been received from a health professional concerning a 4 month old male who on 18-SEP-2006 was vaccinated with a first oral dose of rotavirus G1 G2 G3 G4 P1 veassortant vaccine live (human bovine). No problems with the administration were noted. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a health professional concerning a greater than 12 week old patient who was vaccinated with an initial dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). The child displayed no symptoms. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.This is in follow-up to reports previously submitted on 10/10/2006. Information has been received from a health professional concerning a greater than 12 week old patient, with no medical history and no allergies, who was vaccinated with an initial dose of ROTATEQ. There was no illness at the time of vaccination and no adverse events following prior vaccination. The child displayed no symptoms. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow-up information from an office manager in a physician's office indicated that the patient's parent refused any more doses of ROTATEQ. No adverse signs or symptoms had presented. Additional information is not expected.
Age: 0.3
Sex: F
Vaccine: RV5
Symptoms: Infection
Clinical narrative: Information has been received from a physician concerning a 4 month old female with no medical history and no allergies, who on 09-SEP-2006 was vaccinated with a second oral dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). Three days after on 12-SEP-2006, the patient developed an ear infection. The patient was given antibiotics and the ear infection resolved. There were no laboratory or diagnostic tests performed. No additional information was provided. Additional information has been requested.
Age: 0.6
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 7 month old male who was vaccinated with a first 2 ml oral dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). There was no concomitant medication. Subsequently the patient experienced diarrhea and vomiting that had resolved in three days. It was noted that remaining doses of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine) were not administered. The patient did not require an office visit for the diarrhea and vomiting. Unspecified medical attention was sought. No product quality complaint was involved. No additional information was provided. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning three patients who on approximately 18-SEP-2006 was vaccinated with 2 ml PO first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). It was reported that they were vaccinated at 16 weeks of age. There were no problems with the administration of the vaccine. Medical attention was sought. There was no product quality complaint involved. 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. Additional information has been requested. This is in follow-up to report (s) previously submitted on 10/10/2006.  Information has been received from a registered nurse concerning a patient who on approximately 18-SEP-2006 was vaccinated with 2 mL PO first dose of ROTATEQ.  It was reported that the patient was vaccinated at 16 weeks of age.  There were no problems with the administration of the vaccine.  Medical attention was sought.  There was no product quality complaint involved.  Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Medication error
Clinical narrative: Information has been received from a physician concerning a 6 month old patient who on 21-SEP-2006 was vaccinated with a first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). No adverse events were reported. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 0.6
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 7 month old male who was vaccinated with a first 2 ml oral dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). There was no concomitant medication. Subsequently the patient experienced diarrhea and vomiting that had resolved in six days. It was noted that remaining doses of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine) were not administered. The patient did not require an office visit for the diarrhea and vomiting. Unspecified medical attention was sought. No product quality complaint was involved. No additional information was provided. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Faeces discoloured
Clinical narrative: Information has been received from a health professional concerning a 4 month old male who at "2 months of age" on approximately 28-JUL-2006 was vaccinated with a first oral dose of rotavirus G1 G2 G3 G4 P1 reassorted vaccine live (human bovine). On 08-SEP-2006 the patient developed diarrhea and green stools. The stool was not cultured. It was noted that the patient did not appear ill as he was eating normally and thriving. The patient was treated symptomatically and appeared to be recovering. There were no laboratory or diagnostic tests performed. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Abdominal pain
Clinical narrative: Information has been received from a physician concerning a 6 month old male with no medical history and no allergies who on 03-JUN-2006 was vaccinated with a first 2 ml oral dose of Rotateq (Lot #653915/0389F). Subsequently, on 03-JUN-2006 the patient experienced cramping, but no vomiting for diarrhea. It was reported that the patient recovered within 5 days. On 25-JUL-2006 the patient was vaccinated with a second 2 ml dose of rotavirus G1 G2 G3 G4 P1 reassorted vaccine live (human bovine) (Lot # 653915/0389F). Concomitant vaccines administered on 24-JUL-2006 included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified)  (+) tetanus toxoid, a dose of poliovirus vaccine, a dose of pneumococcal 5 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar) and a dose of HIB conj-hepatitis B vaccine (MSD). Subsequently on 25-JUL-2006 the patient experienced cramping but had no vomiting or diarrhea. It was reported that the patient recovered within 5 days. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow-up information from a physician indicated that the patient's mother reporter at her son's & month check up that after the second dose of ROTATEQ at the patient's 4 month check-up that he acted "not quite right", and he seemed like he had a stomach ache for a few days.Additional information has been requested.
Age: 0.45
Sex: M
Vaccine: RV5
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a registered nurse concerning a 5 month old male who was vaccinated a first and second dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine) on 20 June 2006 and 25 September 2006 (lot # 654970/0777F), respectively.  No problems were reported.  It was unknown if medical attention was sought.  There was no product quality complaint involved.   Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This is in follow-up to report(s) previously submitted on 10/10/2006. Information has been received from a certified medical assistant (CMA) concerning a 6-month-old male patient who on 28 August 2006 was vaccinated PO with the first 2.0 mL dose of ROTATEQ (Lot #654664/0726F).  It was unknown if medical attention was sought an no adverse event was reported.  The patient did not have any symptoms.  Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Vomiting  Information has been received from a physician concerning an infant who on 25 September 2006 was vaccinated with a 2 mL PO dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine).  Subsequently the patient "threw it up".  The patient was not experiencing any known symptoms.  Unspecified medical attention was sought.  There was no product quality complaint involved.  Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: RV5
Symptoms: Unevaluable event
Clinical narrative: Inappropriate schedule of drug administration; no adverse effect.  Information has been received from a doctor of philosophy (PhD) concerning his 20 week old son who was vaccinated with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine).  Unspecified medical attention was sought and no problems were reported.    Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: DTAP, HBHEPB, IPV, RV5
Symptoms: Crying, Decreased appetite, Gastrooesophageal reflux disease, Irritability, X-ray gastrointestinal tract normal
Clinical narrative: Information has been received from a physician concerning an infant who was vaccinated PO with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine) (lot number not reported). The physician reported that the infant subsequently developed GERD and irritability. Unspecified medical attention was sought. The physician recommended further testing for the GERD (not further specified). 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 10/10/2006.  Follow-up information has been received from a physician concerning a 15-week-old white male who on 07-JUL-2006, at 1000, was vaccinated PO with the first dose of ROTATEQ (Lot #653661/0138F).   Concomitant vaccinations administered on that same day and time included a dose of DAPTACEL, a dose of COMVAX, a dose of PREVNAR and a dose of IPOL.  Illness at the time of vaccination included nasal congestion.  The physician reported that on the night of 14-AUG-2006, the patient began crying.  On 31-AUG-2006, the patient was seen by the physician and was noted to have thrush and refusal to feed.  On 05-SEP-2005, the patient was crying and had difficulty eating.  On 13-SEP-2006, a diagnosis of GERD was made.  On 29-SEP-2006, a Barium swallow and upper GI series were both normal.  On 06-OCT-2006, a modified Barium swallow revealed that the patient had a disorganized suck-swallow (physician felt that this may have been present since birth as the patient's mother was unable to breast feed).  The physician felt that due to the patient's disorganized suck-swallow, her GERD was not related to ROTATEQ.  The patient improved with famotidine (MSD) and REGLAN.  It was also noted that the patient was only formula fed and had multiple changes in brand and type.  At the time of this report, the patient was recovering, but was noted not to be fully recovered.  Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: DTAP, HBHEPB, IPV, RV5
Symptoms: X-ray normal
Clinical narrative: Information has been received from a physician concerning an infant who was vaccinated PO with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine) (lot number not reported). The physician reported that the infant subsequently developed GERD and irritability. Unspecified medical attention was sought. The physician recommended further testing for the GERD (not further specified). 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 10/10/2006.  Follow-up information has been received from a physician concerning a 15-week-old white male who on 07-JUL-2006, at 1000, was vaccinated PO with the first dose of ROTATEQ (Lot #653661/0138F).   Concomitant vaccinations administered on that same day and time included a dose of DAPTACEL, a dose of COMVAX, a dose of PREVNAR and a dose of IPOL.  Illness at the time of vaccination included nasal congestion.  The physician reported that on the night of 14-AUG-2006, the patient began crying.  On 31-AUG-2006, the patient was seen by the physician and was noted to have thrush and refusal to feed.  On 05-SEP-2005, the patient was crying and had difficulty eating.  On 13-SEP-2006, a diagnosis of GERD was made.  On 29-SEP-2006, a Barium swallow and upper GI series were both normal.  On 06-OCT-2006, a modified Barium swallow revealed that the patient had a disorganized suck-swallow (physician felt that this may have been present since birth as the patient's mother was unable to breast feed).  The physician felt that due to the patient's disorganized suck-swallow, her GERD was not related to ROTATEQ.  The patient improved with famotidine (MSD) and REGLAN.  It was also noted that the patient was only formula fed and had multiple changes in brand and type.  At the time of this report, the patient was recovering, but was noted not to be fully recovered.  Additional information has been requested.
Age: 0.18
Sex: F
Vaccine: HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 9 week old female with gastric reflux and no allergies who on 14-SEP-2006 was vaccinated PO with a 2.0ml dose of  rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine); (lot #655082/0779F). Concomitant vaccination administered on that same day included a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar). Hib conj vaccine (OMPC) (manufacturer unknown). Other concomitant therapy included ranitidine HCL (Zantac). The LPN reported that on 14-SEPY-2006 the patient regurgitated the dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). Unspecified medical treatment was sought but no laboratory/diagnostic tests were performed. On that same day the patient recovered. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: Medication error
Clinical narrative: Information has been received from a physician concerning a 5 month old patient who on 28-SEP-2006 was vaccinated PO with first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine) with no adverse effect. It was unknown if medical attention was sought. No further information is available.
Sex: U
Vaccine: RV5
Symptoms: Medication error
Clinical narrative: Information has been received from a physician concerning children who were vaccinated with rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine) at greater than 12 weeks of age. The reported noted that the series completed by 32 weeks of age in the infants. No symptoms were present. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Sex: M
Vaccine: RV5
Symptoms: Medication error
Clinical narrative: Information has been received from a health professional concerning a male child who on 16-SEP-2006 was vaccinated with an oral 2 ml second dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). "Ten days after" on 26-SEP-2006 the patient was vaccinated with a third 2 ml oral dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine) (Lot #654489/0941F). The patient was not experiencing any known symptoms. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a health professional concerning 4-6 month old patients who were vaccinated with 2 ml oral dose of ROTATEQ. It was not indicated if only one dose was given, or it the full three week regimen was completed. Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/10/2006. Information has been received from a health professional concerning 4-6 month old patients who were vaccinated with 2 ml oral doses of ROTATEQ. It was not indicated if only one dose was given, or if the full three week regimen was completed. Follow-up information indicated that no patients were actually involved in the previously reported experience. Therefore, WAES# 0609USA08405 is being deleted from our files on ROTATEQ. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Pyrexia
Clinical narrative: Information has been received from a nurse concerning a patient who was vaccinated with a dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). the nurse reported that the patient was subsequently rushed to the Emergency Room (ER) after developing a high fever. At the time of this report, the patient was noted to be recovering. The nurse considered high fever to be an other important medical event. Additional information has been requested.
Age: 0.35
Sex: M
Vaccine: HIBV, IPV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration, Overdose
Clinical narrative: Information has been received from a physician concerning a four month old patient who on approximately 28-JUL2006 at two month of age was vaccinated PO with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). The physician reported that on 28-SEP-2006 the patient was administered two PO doses of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). It was unknown if medical attention was sought. No adverse experience was reported. 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 10/10/2006.  Information has been received from a physician concerning a 18-week-old white male who on 28-JUL-2006, at two months of age, was vaccinated PO with the first dose of ROTATEQ.  The physician reported that on 28-SEP-2006, at 1600, the patient was administered two PO doses of ROTATEQ (Lot #653755/0319F & Lot #655174/0848F), respectively.  Concomitant vaccinations on that same day and time included the second IM dose in the right vastus lateralis of PEDVAXHIB (652863/0401F), the second SC dose in the left vastus lateralis of IPOL (Lot #Y0991), the second IM dose in the left vastus lateralis of PREVNAR (Lot #B08670C) and the second dose in the right vastus lateralis of DTAP.  Medical attention was not sought and no adverse experience was reported.  Additional information is not expected.
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning their niece who was vaccinated with a dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). The physician reported that their niece subsequently developed diarrhea. Unspecified medical attention was sought. After three days the diarrhea resolved. No further information is available.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Acidosis, Dehydration, Diarrhoea, Gastroenteritis, Irritability
Clinical narrative: Information has been received concerning a 2-month-old male who on 31-JUL-2006, at 1002, was vaccinated by mouth with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (Lot#653755/0319F). Concomitant vaccinations administered on the same day and time included the first dose of diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid (PEDIARIX) (Lot#AC21B066AA), a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (Lot#B08657E) and the first dose of Hib conj vaccine (tet toxoid) ACTHIB) (Lot#UE885AA).  Illness at the time of vaccination included right otitis media (treated with amoxicillin).  It was reported that in 2006, the patient was fussy and developed diarrhea. The patient was subsequently hospitalized for 2-4 days and was discharged.  At the time of this report, the outcome was unknown.  Additional information has been received via medical records concerning a 10-week-old male with no frequent illness and no known drug allergies (NKDA) who on 31-JUL-2006, after being vaccinated became cranky and developed stomach bloating nd diarrhea.  On 04-AUG-2006, the patient was hospitalized due to fever, irritability, abdominal bloating and diarrhea.  The diarrhea was eight times per day and was not improving and seemed to be getting worse.  The patient had been treated with Pedialyte but had not improved.  The patient also looked dehydrated, sick and acidotic.  At the time of admission, the patient was very very cranky but not cyanotic or tachypneic and had not slept well due to the fever and stomach bloating.  He was alert and awake .  There was no history of bloody stool.  The patient cried without tears.  His lips were dry, but occasionally had some redness but no cyanosis.  The diarrhea was watery and brownish and dark green in color.  The patient had not vomited.  The patient was treated with intravenous (IV) fluids and Pedialyte was gradually added.  When the patient improved, half strength Progestamil was given.  A stool  culture grew normal enteric flora (see laboratory/diagnostic section for additional results).  The patient gradually improved .  On 07-AUG-2006, the patient was discharged from the hospital with a discharge of acute gastroenteritis with dehydration and metabolic acidosis.  At the time of discharge the patient was being treated with half strength Progestamil for one day and then with full strength.  The mother was advised to bring her son back for follow up on 09-AUG-2006.  No information is available.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Otitis media
Clinical narrative: Information has been received concerning a 2-month-old male who on 31-JUL-2006, at 1002, was vaccinated by mouth with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (Lot#653755/0319F). Concomitant vaccinations administered on the same day and time included the first dose of diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid (PEDIARIX) (Lot#AC21B066AA), a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (Lot#B08657E) and the first dose of Hib conj vaccine (tet toxoid) ACTHIB) (Lot#UE885AA).  Illness at the time of vaccination included right otitis media (treated with amoxicillin).  It was reported that in 2006, the patient was fussy and developed diarrhea. The patient was subsequently hospitalized for 2-4 days and was discharged.  At the time of this report, the outcome was unknown.  Additional information has been received via medical records concerning a 10-week-old male with no frequent illness and no known drug allergies (NKDA) who on 31-JUL-2006, after being vaccinated became cranky and developed stomach bloating nd diarrhea.  On 04-AUG-2006, the patient was hospitalized due to fever, irritability, abdominal bloating and diarrhea.  The diarrhea was eight times per day and was not improving and seemed to be getting worse.  The patient had been treated with Pedialyte but had not improved.  The patient also looked dehydrated, sick and acidotic.  At the time of admission, the patient was very very cranky but not cyanotic or tachypneic and had not slept well due to the fever and stomach bloating.  He was alert and awake .  There was no history of bloody stool.  The patient cried without tears.  His lips were dry, but occasionally had some redness but no cyanosis.  The diarrhea was watery and brownish and dark green in color.  The patient had not vomited.  The patient was treated with intravenous (IV) fluids and Pedialyte was gradually added.  When the patient improved, half strength Progestamil was given.  A stool  culture grew normal enteric flora (see laboratory/diagnostic section for additional results).  The patient gradually improved .  On 07-AUG-2006, the patient was discharged from the hospital with a discharge of acute gastroenteritis with dehydration and metabolic acidosis.  At the time of discharge the patient was being treated with half strength Progestamil for one day and then with full strength.  The mother was advised to bring her son back for follow up on 09-AUG-2006.  No information is available.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Irritability
Clinical narrative: Information has been received concerning a 2-month-old male who on 31-JUL-2006, at 1002, was vaccinated by mouth with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (Lot#653755/0319F). Concomitant vaccinations administered on the same day and time included the first dose of diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid (PEDIARIX) (Lot#AC21B066AA), a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (Lot#B08657E) and the first dose of Hib conj vaccine (tet toxoid) ACTHIB) (Lot#UE885AA).  Illness at the time of vaccination included right otitis media (treated with amoxicillin).  It was reported that in 2006, the patient was fussy and developed diarrhea. The patient was subsequently hospitalized for 2-4 days and was discharged.  At the time of this report, the outcome was unknown.  Additional information has been received via medical records concerning a 10-week-old male with no frequent illness and no known drug allergies (NKDA) who on 31-JUL-2006, after being vaccinated became cranky and developed stomach bloating nd diarrhea.  On 04-AUG-2006, the patient was hospitalized due to fever, irritability, abdominal bloating and diarrhea.  The diarrhea was eight times per day and was not improving and seemed to be getting worse.  The patient had been treated with Pedialyte but had not improved.  The patient also looked dehydrated, sick and acidotic.  At the time of admission, the patient was very very cranky but not cyanotic or tachypneic and had not slept well due to the fever and stomach bloating.  He was alert and awake .  There was no history of bloody stool.  The patient cried without tears.  His lips were dry, but occasionally had some redness but no cyanosis.  The diarrhea was watery and brownish and dark green in color.  The patient had not vomited.  The patient was treated with intravenous (IV) fluids and Pedialyte was gradually added.  When the patient improved, half strength Progestamil was given.  A stool  culture grew normal enteric flora (see laboratory/diagnostic section for additional results).  The patient gradually improved .  On 07-AUG-2006, the patient was discharged from the hospital with a discharge of acute gastroenteritis with dehydration and metabolic acidosis.  At the time of discharge the patient was being treated with half strength Progestamil for one day and then with full strength.  The mother was advised to bring her son back for follow up on 09-AUG-2006.  No information is available.