chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: M
Vaccine: RAB
Symptoms: Diarrhoea, Fatigue, Nausea, Vomiting
Clinical narrative: 5 hours after receiving 1st Rabies dose, complained of nausea, vomit, diarrhea.  Next day complained of fatigue then felt fine the following day.  Denies fever or respiratory symptoms, denies hives.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Convulsion, Cyanosis, Paraesthesia oral, Respiratory distress
Clinical narrative: The following was reported to me on 06/27/08: On 08/28/08 the client received PEDIARIX, Hib, PCV 7 and TB skin tests. Ct's parents reported approx 1 hr to 1.5 hr after immunizations were given, pt had a seizure, respiratory distress, as noted by the lips and bluish tinge around nose. Ct was seen by EMS & ER visit, cx completely recovered. Ct has since received all childhood vaccines immunizations except pertussis w/no problems. Ct did not have fever or rash with the tx of vaccine.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Medication error
Clinical narrative: Pt. said she'd never received Hep B series.  I though I checked her imm. record.  When I went to chart it I saw she had the series in 2000+2001.  I reported this to pt, doctor, and others.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Rash
Clinical narrative: Patient came in on 7/16/08 have rash all over his upper arm red.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Autopsy, Death, Spleen disorder
Clinical narrative: Pt received her 3rd and final dose of HPV vaccine on 6/3/08.  Per mother patient was found dead, in bed on 6/22/08, in her dorm room at an out-of-state college.  According to the autopsy the patient had been dead for about 48 hours.  According to mother autopsy was negative except for splenic inflammation. 8/22/08 Autopsy report also states Final Diagnoses: Cardiac arrest, cause undetermined w/recent history of PAC w/otherwise normal EKG; normal echocardiogram 2/08; no evidence of myocarditis; acute pulmonary edema; slight splenomegaly; cardiac blood neg for ethanol; urine (+) for ethanol=16 mg/dl; liver (+) for acetaldehyde (incidental finding). 3/5/09-records received for DOS 8/22/07-seen for routine visit and first annual pap test..PE normal.  First HPV vaccine administered. 2/4/09-records received for DOS 11/20/07-C/O chronic PAC and irregular heart beat.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Death
Clinical narrative: Pt received her 3rd and final dose of HPV vaccine on 6/3/08.  Per mother patient was found dead, in bed on 6/22/08, in her dorm room at an out-of-state college.  According to the autopsy the patient had been dead for about 48 hours.  According to mother autopsy was negative except for splenic inflammation. 8/22/08 Autopsy report also states Final Diagnoses: Cardiac arrest, cause undetermined w/recent history of PAC w/otherwise normal EKG; normal echocardiogram 2/08; no evidence of myocarditis; acute pulmonary edema; slight splenomegaly; cardiac blood neg for ethanol; urine (+) for ethanol=16 mg/dl; liver (+) for acetaldehyde (incidental finding). 3/5/09-records received for DOS 8/22/07-seen for routine visit and first annual pap test..PE normal.  First HPV vaccine administered. 2/4/09-records received for DOS 11/20/07-C/O chronic PAC and irregular heart beat.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Autopsy, Death, Fatigue, Splenitis, Viral infection
Clinical narrative: Pt received her 3rd and final dose of HPV vaccine on 6/3/08.  Per mother patient was found dead, in bed on 6/22/08, in her dorm room at an out-of-state college.  According to the autopsy the patient had been dead for about 48 hours.  According to mother autopsy was negative except for splenic inflammation. 8/22/08 Autopsy report also states Final Diagnoses: Cardiac arrest, cause undetermined w/recent history of PAC w/otherwise normal EKG; normal echocardiogram 2/08; no evidence of myocarditis; acute pulmonary edema; slight splenomegaly; cardiac blood neg for ethanol; urine (+) for ethanol=16 mg/dl; liver (+) for acetaldehyde (incidental finding). 3/5/09-records received for DOS 8/22/07-seen for routine visit and first annual pap test..PE normal.  First HPV vaccine administered. 2/4/09-records received for DOS 11/20/07-C/O chronic PAC and irregular heart beat.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Autopsy, Death, Pulmonary oedema
Clinical narrative: Pt received her 3rd and final dose of HPV vaccine on 6/3/08.  Per mother patient was found dead, in bed on 6/22/08, in her dorm room at an out-of-state college.  According to the autopsy the patient had been dead for about 48 hours.  According to mother autopsy was negative except for splenic inflammation. 8/22/08 Autopsy report also states Final Diagnoses: Cardiac arrest, cause undetermined w/recent history of PAC w/otherwise normal EKG; normal echocardiogram 2/08; no evidence of myocarditis; acute pulmonary edema; slight splenomegaly; cardiac blood neg for ethanol; urine (+) for ethanol=16 mg/dl; liver (+) for acetaldehyde (incidental finding). 3/5/09-records received for DOS 8/22/07-seen for routine visit and first annual pap test..PE normal.  First HPV vaccine administered. 2/4/09-records received for DOS 11/20/07-C/O chronic PAC and irregular heart beat.
Age: 0.58
Sex: F
Vaccine: RV5
Symptoms: Abdominal mass, Abdominal rigidity, Constipation, Flatulence, Pain
Clinical narrative: 14 days after last dose of RotaTeq, he vomited four times & had intermittent severe abdominal spasm manifested by writhing & arching & flatus.  No stool in rectum for 36 hours.  Ovoid mass palpable in RUQ, resolved when pain abated.  7/30/2008 ER rec dated 12/12/2007. Pt presented with episodes of back arching, screaming and drawing up of legs in pain after feeds, vomiting x4 as well as increased sleepiness. DX: Vomiting-resolved.  Emesis not bloody or green. BS (+). Abdomen soft.
Age: 0.58
Sex: F
Vaccine: RV5
Symptoms: Ultrasound scan normal, Vomiting
Clinical narrative: 14 days after last dose of RotaTeq, he vomited four times & had intermittent severe abdominal spasm manifested by writhing & arching & flatus.  No stool in rectum for 36 hours.  Ovoid mass palpable in RUQ, resolved when pain abated.  7/30/2008 ER rec dated 12/12/2007. Pt presented with episodes of back arching, screaming and drawing up of legs in pain after feeds, vomiting x4 as well as increased sleepiness. DX: Vomiting-resolved.  Emesis not bloody or green. BS (+). Abdomen soft.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Balance disorder, Blood glucose, Blood pressure, Cold sweat, Disorientation
Clinical narrative: Patient given immunizations @ 10:55 and reported felt light headed and loss balance. Face red,hands shaking,cold &clammy, eyes glazed, unware of her surroundings. Doctor responded. Vital signs recorded Q 5 minutes BP 96/56 pulse 72(normal for patient) Oxygen given @ 2 liters Monitored until 11:45 and released to return on 07/17/2008 for follow-up
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Erythema, Gaze palsy, Heart rate normal, Tremor
Clinical narrative: Patient given immunizations @ 10:55 and reported felt light headed and loss balance. Face red,hands shaking,cold &clammy, eyes glazed, unware of her surroundings. Doctor responded. Vital signs recorded Q 5 minutes BP 96/56 pulse 72(normal for patient) Oxygen given @ 2 liters Monitored until 11:45 and released to return on 07/17/2008 for follow-up
Age: 48.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Inappropriate schedule of drug administration, Injection site pain, Injection site swelling
Clinical narrative: MA failed to see documentation on new hire chart that gave dates of the Tdap (5/20/08) and Hep B #2 vaccinations (6/23/08).  The MA gave the new hire a Tdap and a Twinrix on 7/14/08.  The new hire complained of pain to the Tdap site - (I'm still having pain to my arm.") There was minimal swelling and no redness noted, however, the new hire is a person of color, so there may have been slight redness that I was unable to discern.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Vaccination failure, Varicella
Clinical narrative: PATIENT DX WITH CHICKEN POX ON 7/16/2008
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Diffuse maculopapular rash
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Injection site discolouration, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Vaccines administered 7-15-08.  Mother noticed redness on left arm 7-16-08. On 7-17-08, Mother noticed redness, swelling, and yellow discoloration from the vaccine site to 1 or 2 inches above elbow of left arm.  It is very warm to touch.  Child c/o itching but is not in pain according to mother.  She called to report symptoms 7-17-08.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Blister, Erythema, Rash, Vaccination failure, Varicella
Clinical narrative: Child recieved second dose of Varicella vaccine on June 30, 2008. Mother called on 7/16/2008 and left message stating child had Doctor documented case of Chicken Pox. Child woke up on 7/12/2008 with "a nickel size red spot on stomach and then the next day blisters appeared.  On 7/14/2008 more blisters appeared around the larger one on the abdomen".Today when I called and talked to the mother she said there were two smaller "pox" on the child's back.
Age: 14.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Oedema peripheral, Pain in extremity
Clinical narrative: 24 hours after injection began to have arm swelling and pain.  seen in clinic at 48hrs. with arm swelling about 6cm with injection site at center mild hue of erythema.  Treated with benadryl and ice to site. Patient to call if any increase in erythema, pain, or fever.
Age: 5.0
Sex: F
Vaccine: IPV
Symptoms: Rash, Rash maculo-papular
Clinical narrative: 3 DAYS AFTER RECEIVING THE IPV ONLY DEVELOPED A RED MACULAR PAPULAR RASH ON THE ANTECUBES,TRUNK AND EXTREMETIES
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: Pain in the injection site, headache, tiredness, chills, body aches, sore joints, redness and swelling at the injection site, fever (did not take temp but definitely have a fever.  Had Tdap Vaccine administered to me at approximately 1715 on July 15, 2008.  The following day around 1200, started feeling extremely tired and by 1600 the rest of the above mentioned reactions were coming on.  At this time I have not seeked Medical attention.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: Pain in the injection site, headache, tiredness, chills, body aches, sore joints, redness and swelling at the injection site, fever (did not take temp but definitely have a fever.  Had Tdap Vaccine administered to me at approximately 1715 on July 15, 2008.  The following day around 1200, started feeling extremely tired and by 1600 the rest of the above mentioned reactions were coming on.  At this time I have not seeked Medical attention.
Age: 5.0
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Erythema
Clinical narrative: Patient received 4 year old vaccines - Dtap, MMR,IPV, and Varicella.  PPD placed.  Child experienced an area of erythema approximately 6 inches in diameter - ?Dtap.  Unable to verify which vaccine due to glich in computer system.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Erythema,swelling and pain at injection size approximately 5 cm in size.  Treated with cool or warm compress, aleve prn and f/u prn
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Pruritus, Swelling, Throat tightness, Urticaria
Clinical narrative: SWELLING, ITCHING, HIVES,THROAT FELT TIGHT APPROX 20 HRS POST VACCINATION.  PT WENT TO ER, TEHN F/U W/ PCM ON 17 JUL.  PRESCRIBED STEROIDS, EPI-PEN, INSTRUCTED TO CONTINUE BENADRYL ALONG WITH STEROIDS.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Balance disorder, Crying, Dizziness, Eye pain, Eye rolling
Clinical narrative: The child received DTaP vaccine on Jul 16 2007.  On July 2007 am the child walked up to mom and cried his   eyes and head were hurting followed by acting dizzy/unsteady and eyes rolling back in head several times over a 2-3 minute period.  He remained standing/conscious during the entire episode and became completely normal afterwards.  He was examined in the office about 3 hours after the event and had a totally normal examination in general and neurologically.  Based on this we have decided to observe the child for the time being.  If recurrent events develop we will begin a more thorough neurological work up to include EEG and a screening laboratory evaluation.  As the mother was concerned about the event in relationship to the recent vaccine we decided to make this report to VAERS to be complete and make sure others have not had a similar event.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Headache, Neurological examination normal, Physical examination normal
Clinical narrative: The child received DTaP vaccine on Jul 16 2007.  On July 2007 am the child walked up to mom and cried his   eyes and head were hurting followed by acting dizzy/unsteady and eyes rolling back in head several times over a 2-3 minute period.  He remained standing/conscious during the entire episode and became completely normal afterwards.  He was examined in the office about 3 hours after the event and had a totally normal examination in general and neurologically.  Based on this we have decided to observe the child for the time being.  If recurrent events develop we will begin a more thorough neurological work up to include EEG and a screening laboratory evaluation.  As the mother was concerned about the event in relationship to the recent vaccine we decided to make this report to VAERS to be complete and make sure others have not had a similar event.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Crying, Depression, Inappropriate schedule of drug administration, Thinking abnormal
Clinical narrative: On February 21st of 2008 I received my first hpv and first hepatitis b vaccines and was told to come back in one month for my 2nd hepatiits b shot and then the following month I'd receive my 2nd hpv shot. So on the 27th of March I recieved what I though to be my second hepatitis b shot. With in days I had dropped into a very bad depression. I was crying all the time, could hardly function and had no idea what was causing all of this. I wanted to die and I didn't know why it got so bad I started to call help lines and tried to decide if I should see about getting some medical help. It was the worst I have ever felt in my life, I felt completely out of control. Finally after about 3 weeks of what I can only describe as hell, I started to feel a little better, then I received a bill I was being charged for my 2nd hpv shot not my 2nd hepatitis b! After talking to my mother and putting dates and everything together I believe that my deep depression was soley caused by receiving my 2nd hpv shot a month sooner than I'd expected. We immediatly made an appointment with the clinic to discuss there huge error. They refused to admit any mistake on their part due to that fact that the recommended time inbetween dosing on the hpv serious had change. They would only admit that they should have also given me the 2nd hepitis b shot as well as the 2nd hpv shot I'd received. No one told me that day that the plan had changed that I would be recieving the 2nd hpv shot a month sooner than planned. Not only do I think the clinic was inapt in their communicating my course of treatment but I believe that the 2nd hpv shot sent me into at least 3 weeks of severe depression that with out the help and support of my family and a close friend I don't know if I'd have made it through on my own. After thinking about everything I feel it is my responsiblitiy to tell you the reaction that I had from my 2nd shot, in hopes that maybe others have come forward and it will stop anyone else in the futre from suffering the same horrible side effect.I had decided not to continue the series and get the 3rd shot as I do not have any confidence left in series. I don't believe that it has been studied enough and will not risk having another adverse reaction as I did to the last one. I hope that if I am not the only one that has come foward with this reaction that it is taken very seriously. It may not have resulted in my death or caused any long term effects that I have become aware of but it was a severe reaction one that I was never warned or advised could happen, had I known it was a possible side effect I would never had agreed to the series in the first place.
Age: 14.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Urticaria
Clinical narrative: Mother of patient came in office on 07/17/2008 stated that she notice a large circular wheal on the arm in area where Varicella vaccine was administered on 07/16/2008. The wheal was noticed this morning and mom brought patient into the office.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Local reaction, Mass
Clinical narrative: Patient presented 7/17/08 with golf ball size, red, raised, warm to touch area on left upper arm.  This was previous injection site of Varicella vaccine given on 7/15/08.  Doctor diagnosed with localized reaction to Varicella vaccine and treated with Benadryl TID x 1 week prn as well as warm compresses TID prn.  Follow up if symptoms persist.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient received two MENACTRA vaccines. #1 on 11-5-07 and #2 on 7-17-08
Age: 0.5
Sex: F
Vaccine: HIBV, IPV, PNC, TDAP
Symptoms: Incorrect dose administered
Clinical narrative: Pt was administered adolescent/adult dose of Tdap (ADACEL) instead of pediatric dose (DAPTACEL).
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Hypersensitivity, Rash erythematous, Rash pruritic
Clinical narrative: Allergy in the whole body, rashes red and itchy.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Erythema, Rash generalised
Clinical narrative: Allergy in the whole body, rashes red and itchy.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Blood pressure decreased, Gaze palsy, Injection site pain, Moaning, Syncope
Clinical narrative: Patient received, TDAP, Varivax and Gardasil immunization.  After receiving Gardasil, patient stated that hurt worse.  She then moaned and fell on her side lying on table, eyes rolled back and fainted after 20 seconds.  Received orange juice, water and granola bar.  Blood pressure taken before patient left was 70/40.  Original blood pressure 80/50.  Patient was in stable condition upon leaving per doctor.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Patient received GARDASIL on 5/15/08. Patient developed intermittent episodes of dizziness starting 5/22/08 continuing daily until 6/12/08. Episodes subsided hen and have not reoccurred. This information reported on 7/17/08 by mother to our office.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Crying, Injection site erythema, Irritability
Clinical narrative: Fussiness, extreme incessant crying, erythema (large) at site of injection R upper ant thigh.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Medication error
Clinical narrative: Rec'd call from Dr. 7/8/08 in reference to above pt. to confirm if child had received vaccines at our clinic.  Child has hx of lymphoma & is recovering chemo therapy.  Dx. 10/06 at different facility.  Parent did not inform nurse of/but denied any medical issues when questioned prior to receiving vaccines.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Ear pain, Local swelling, Musculoskeletal pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: Associate states developed sore throat at 1900 hrs 7/9/08. Associate states on 7/10/08 noticed throat pain with neck swelling at 1900 hrs with swallowing. Notified by associate on 7/11/08 at approx 1345 hrs of neck swelling, stiffness with radiating pain to (L) shoulder, (L) ear and throat. Seen in Emerg Dept for evaluation. On 7/14/08, associate states symptoms nearly all resolved. On 7/17/08 - assoc states all resolved.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Pharyngolaryngeal pain
Clinical narrative: Associate states developed sore throat at 1900 hrs 7/9/08. Associate states on 7/10/08 noticed throat pain with neck swelling at 1900 hrs with swallowing. Notified by associate on 7/11/08 at approx 1345 hrs of neck swelling, stiffness with radiating pain to (L) shoulder, (L) ear and throat. Seen in Emerg Dept for evaluation. On 7/14/08, associate states symptoms nearly all resolved. On 7/17/08 - assoc states all resolved.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: "none"
Age: 10.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Pallor, Throat irritation, Vomiting
Clinical narrative: Within seconds after VARIVAX booster vaccine being given, patient complained of throat itching and vomited. Became very pale - was given Epinephrine and Benadryl.
Age: 10.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Foaming at mouth, Immediate post-injection reaction, Pallor, Throat irritation, Vomiting
Clinical narrative: Within seconds after VARIVAX booster vaccine being given, patient complained of throat itching and vomited. Became very pale - was given Epinephrine and Benadryl.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt received routine IZ's on 7-15-08.  Got DTaP, IPV, MMR, VARIVAX, Hep A, and PPD.  Mom states next day L arm swollen, red & painful.
Age: 7.0
Sex: F
Vaccine: HEPA
Symptoms: Rash, Urticaria
Clinical narrative: Received 2nd dose of hepatitis A vaccine 6/27/08.  2 days later went to ER for "rash" (was urticaria).  Given prednisone 30mg/day for 3 days.  On next day.  Trunk, legs, & face were involved.  Played outdoors.  Waded ankle deep in river seen in office 7/2/08 & 50 MEDROL given (60mg) then prednisone.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Local reaction
Clinical narrative: Severe local redness, swelling & induration at injection site R deltoid.  8cm x 6 1/2cm.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 5 month old female who female who on 14-MAR-2008 and 31-MAR-2008 was vaccinated po with the first and second doses of ROTATEQ. No adverse event was reported. Additional information has been requested.
Sex: M
Vaccine: RV5
Symptoms: Decreased appetite, Diarrhoea, Pyrexia
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated po with the first dose of ROTATEQ. It was reported that 24 hours after receiving the vaccine the patient developed persistent diarrhea, a little fever and would not eat as much. Unspecified medical attention was sought. The outcome was not reported. A product quality complaint was not involved. No further information is available.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning an approximately 2 month old patient, who on approximately 22-MAY-2008 was vaccinated po with ROTATEQ. It was reported on approximately 24-MAY-2008 the patient experienced prolonged diarrhea. The patient's out was reported as not recovered. 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 licensed practical nurse concerning a 14 week old patient who was vaccinated with the first dose or ROTATEQ (date unspecified). There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Retching, Underdose
Clinical narrative: Information has been received from a physician concerning a patient with a history of gastroschisis who was vaccinated po with the first and second doses of ROTATEQ (dates unspecified). It was reported that the patient was "gagging" on the second dose of ROTATEQ and full dose was not given to patient. The outcome was not reported. A product quality complaint was not involved. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 17 week old patient who on 19-MAR-2008 was vaccinated po with the first dose of ROTATEQ. The RN reported that there was no adverse event. A product quality complaint was not involved. Additional information has been requested.
Age: 0.55
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Inappropriate schedule of drug administration, Rotavirus infection, Rotavirus test positive, Vomiting
Clinical narrative: Information has been received from a nurse concerning an 8 month old patient who was vaccinated po on 04-DEC-2007, 25-JAN-2008 and 09-APR-2008 with the first, second, and third doses of ROTATEQ  (first dose lot # 657606/1391U and third dose lot # 660550/0616X). The nurse reported that the patient developed rotavirus, confirmed by the office lab technician. It was reported that the patient sought medical attention, unspecified. The outcome was not reported.  Follow-up information was received from a nurse concerning a 9 month old (previously reported as an 8 month old) patient. On 03-JUN-2008 the patient experienced vomiting for 3 to 4 days and diarrhea for 2 to 3 days. On 04-JUN-2008 a stool test was done which was positive for Rotozyme, negative hematest and no fecal white blood cells seen. The patient was seen for a doctor  visit. It was reported that the patient recovered.  This is one of several reports from the same source. Additional information has been requested.  No further information is expected.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a patient who on 14-May-2008 and 04-JUN-2008 was vaccinated po with the first and second doses of ROTATEQ. It was reported that the patient did not experience any known symptoms. The outcome is unknown. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 19 week old female who on 11-APR-2008 and 05-Jun-2008 was vaccinated po with the first and second doses respectively of ROTATEQ. No adverse event was reported. It is unknown if medical attention was sought. A product quality complaint was not involved. No further information is available.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a certified medical assistant (CMA) concerning a 10 week old male who on 30-MAY-2008 at 09:30 was vaccinated po with the first dose of ROTATEQ (lot #660380/0277X). The CMA reported that on approximately 01-JUN-2008 the patient had diarrhea and vomiting. It was reported that the stools were "firming" up and the vomiting was a lot less. The CMA instructed the patient's mother to watch and push fluids in small frequent amounts and to call on 06-JUN-2008 if the patient was not better. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 2 month old patient who was vaccinated po with the first 2.0 ml dose of ROTATEQ at 2 months of age (date unspecified). It was reported that the patient did not return for the second dose of ROTATEQ 4 to 10 weeks later. The LPN reported that the patient is now exactly 7 months old (unspecified if patient received second dose at 7 months). No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated po with the first dose of ROTATEQ. It was reported that the patient experienced vomiting within 1 minute of vaccine administration. The child vomited the vaccine in addition to other stomach contents. The physician reported that the mother declined to continue with further doses. It was reported that the patient sought medical attention at the office. The outcome is unknown. A product complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Rotavirus infection, Rotavirus test positive, Salmonellosis, Stool analysis abnormal
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of ROTATEQ, (date, route and dose not indicated). It was reported that the patient tested positive for rotavirus after receiving the vaccine and tested positive for salmonella one to two days after testing positive for rotativirus. No further information was available. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of ROTATEQ (date, route and dose unspecified). The physician reported that after the patient was given the ROTATEQ tested positive for rotavirus. It was reported that the patient sought medical attention, unspecified. The outcome is unknown. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a nurse concerning an 8 week old male who on 12-JUN-2008 was vaccinated po with a dose of ROTATEQ. It was reported that on 12-JUN-2008 that the patient was given the dose of ROTATEQ then had vomiting. The outcome was not reported. A product quality complaint was not involved. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse (RN) concerning an approximately 16 week old female who was vaccinated with the first dose of ROTATEQ (date unspecified). It was reported that the patient received the first dose of ROTATEQ (date unspecified) at 16-17 weeks of age. The RN reported that the patient may receive the second dose now on 13-Jun-2008. The patient sought medical attention in the office. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Rotavirus infection, Rotavirus test positive
Clinical narrative: Information has been received from a nurse concerning a patient who was vaccinated po with a dose of ROTATEQ (date and number of dose unspecified). The nurse reported that the patient developed rotavirus, confirmed by the office lab technician. It was reported that the patient sought medical attention, unspecified. The outcome was not reported.
Age: 0.52
Sex: M
Vaccine: RV5
Symptoms: Occult blood negative, Rotavirus infection, Rotavirus test positive
Clinical narrative: Information has been received from a nurse concerning a patient who was vaccinated po with a dose of ROTATEQ (date and number of dose unspecified). The nurse reported that the patient developed rotavirus, confirmed by the office lab technician. It was reported that the patient sought medical attention, unspecified. The outcome was not reported. This is one of several reports from the same source. Additional information has been requested.  09/02/2008 This is in follow-up to report(s) previously submitted on 7/15/2008. Information has been received from a nurse concerning a 15 month old male with no medical history who was vaccinated PO on 08-MAY-2007, 11-JUL-2007 and 11-SEP-2007 with the first, second and third dose respectively of ROTATEQ (first and second dose lot # 656390/0236U and third dose lot # 654665/0694F). The patient did not have any illness at the time of vaccination. The nurse reported that the patient developed rotavirus, confirmed by the office lab technician. It was reported that the patient sought medical attention, unspecified. The outcome was not reported. Folllow-up information was received from a nurse. On 05-JUN-2008 the patient developed diarrhea that lasted one week. A stool test was done which was positive for Rotozyme, hematest negative and no fecal white blood cells seen. It was reported that the patient was seen for a doctor visit. The patient was reported as recovered on approximately 12-JUN-2008. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, Infantile spitting up, Underdose
Clinical narrative: Information has been received from a registered nurse (RN) concerning a patient who on 03-JUN-2008 was vaccinated po with the second dose of ROTATEQ. It was reported that on 03-JUN-2008 the patient spit up the second dose in the vaccine series. The RN reported on approximately 10-JUN-2008 (one week later) the patient received another po dose of ROTATEQ to replace the incomplete dose. The patient has not experienced any other known symptoms. The outcome has not been reported. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a patient who on on 09-JUN-2008 was given the second oral 2 mL dose of ROTATEQ (Lot# 660292/1832U) and the third 2 mL dose of ROTATEQ (Lot# 660292/1832U) on 16-JUN-2008. The nurse stated that the third dose of GARDASIL early. The patient sought treatment at the physician's office. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Rotavirus infection
Clinical narrative: Information has been received from a nurse concerning a patient who was vaccinated po with a dose of ROTATEQ (date and number of dose unspecified). The nurse reported that the patient developed rotavirus. It was reported that the patient sought medical attention, unspecified. The outcome was not reported. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Rotavirus infection, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning a female who on 06-Nov-2007, 03-Jan-2008 and 06-Mar-2008 was vaccinated po with the first, second and third doses respectively of ROTATEQ. It was reported that on 02-JUN-2008 the patient tested positive (stool specimen) for rotavirus. The physician reported that medical attention was sought (unspecified). The outcome was reported as recovered on 13-Jun-2008. A product quality complaint was not involved. Additional information has been requested.
Age: 0.26
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a female infant who on 05-JUN-2008 was vaccinated with a first dose of ROTATEQ greater than 12 weeks of age. There were no adverse symptoms reported. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/13/2008. Follow-up information has been received from a registered nurse concerning a 13 week old male (previously reported as female). Infant with no known allergies or pertinent medical history who on 05-Jun-2008 was vaccinated orally with a first dose of ROTATEQ (lot # 606427/0280X) at 1:40 PM. The patient had atopic dermatitis at the time of vaccination. There were no adverse symptoms reported. At the time of the report, the patient;s status was unknown. Additional information is not expected.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Rash, Vomiting
Clinical narrative: Information has been received from a physician concerning an approximately 10 week old female infant with "severe protein food in tolerance" who "a week after she was 2 months old" on approximately 26-MAY-2008 was vaccinated orally with a first dose of ROTATEQ (Oka/Merck) (lot # 660378/1928U). There was no concomitant medication. Subsequently, on approximately 29-MAY-2008, "3 days after getting the vaccination" the patient experienced diarrhea, vomiting and rash. It was noted that the gastroenterologist said it was ok to give the vaccination to the child. Unspecified medical attention was sought. It was unspecified if lab studies were performed. At the time of the report the patient recovered on an unspecified date. There was no product quality complaint involved. Additional information has been requested.
Age: 0.14
Sex: F
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 51 day old female infant with no known allergies and reflux who on 02-APR-2008 was vaccinated orally with a first dose of ROTATEQ (Oka/Merck) (lot # 659915/0015X). There was no concomitant medication. Subsequently, on 03-APR-2008 the patient experienced vomiting 2 to 4 times a day for 4 days after administration of the vaccine. Medical attention was sought in the office. There were no lab studies performed. The patient recovered on 07-APR-2008. There was no product quality complaint involved. Additional information has been requested.
Age: 0.08
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a certified medial assistant concerning a 28 day old triplet patient who on 16-JUN-2008 was vaccinated po with the first 2.0 ml dose of ROTATEQ. No adverse event was reported. It was reported that the patient sought medical attention at the office. A product quality complaint was not involved. This is one of several reports from the same source. Additional information has been requested. Follow-up information was recieved from a certified medical assistant who reported that the patient was in the clinic on 16-JUN-2008 for check-up and due to computer error regarding their birthdate (listed as 19-MAR-2008 but actually 19-MAY-2008). It was promised that the patient  was 2 3/4 months adn actually they were 28 days old. The patient received the 2 monthe vaccines by accident. No adverse reactions were reported up to date. This is one of several reports from the same source. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Pyrexia, Rotavirus infection, Rotavirus test positive, Stool analysis
Clinical narrative: This is in follow-up to report(s) previously submitted on 7/15/2008. Information has been received from a physician concerning a 6 month old male who was vaccinated po with the third 2.0 ml dose of ROTATEQ (lot #657986/1205U) on 04-JAN-2008. It was reported that the patient was positive for the rotavirus after receiving the third dose of ROTATEQ. The patient received the first and second dose on 06-SER02007 and 05-NOV-2007. Unspecified medical attention was sought. The outcome is reported as recovered (date unspecified). A product quality complaint was not involved. Additional information has been requested. Follow-up information was received from a registered nurse. The reporter states that the patient (12 kg, 11 inches in height), with no illness at the time of vaccination or pertinent medical history, was seen on 05-JUN-2008 and presented with fever and diarrhea. A stool analysis revealed positive rotavirus antigen by EIA. The patient was only sick overnight and was completely better on 09-JUN-2008. The patient had no adverse events following prior vaccinations. No additional information expected.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Therapeutic response decreased
Clinical narrative: This is in follow-up to report(s) previously submitted on 7/15/2008. Information has been received from a physician concerning a 6 month old male who was vaccinated po with the third 2.0 ml dose of ROTATEQ (lot #657986/1205U) on 04-JAN-2008. It was reported that the patient was positive for the rotavirus after receiving the third dose of ROTATEQ. The patient received the first and second dose on 06-SER02007 and 05-NOV-2007. Unspecified medical attention was sought. The outcome is reported as recovered (date unspecified). A product quality complaint was not involved. Additional information has been requested. Follow-up information was received from a registered nurse. The reporter states that the patient (12 kg, 11 inches in height), with no illness at the time of vaccination or pertinent medical history, was seen on 05-JUN-2008 and presented with fever and diarrhea. A stool analysis revealed positive rotavirus antigen by EIA. The patient was only sick overnight and was completely better on 09-JUN-2008. The patient had no adverse events following prior vaccinations. No additional information expected.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Infantile spitting up, Underdose, Vomiting projectile
Clinical narrative: Information has been received from a licensed practical nurse concerning a 11 week male infant who on 19-JUN-2008 was vaccinated orally with a first dose of an individual pouch single-dose tube of ROTATEQ (Oka/Merck) (lot # 660379/0144X). It was reported that the infant spit up the first part of the dose, then when more was given there was "projectile vomiting." When the remainder of the dose was provided the infant spit it out. Unspecified medical attention was sought. There were no other problems reported. At the time of report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested.
Age: 0.6
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 24 week old male infant who on 19-JUN-2008 was vaccinated orally with a first dose of ROTATEQ (Oka/Merck). It was reported that the patient was inadvertently administered his first dose of 24 weeks old. There were no adverse effects reported. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 4 month old patient who was vaccinated with the first and only dose of ROTATEQ. No adverse effect reported. A product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Gastroenteritis rotavirus
Clinical narrative: Information has been received from a physician concerning a female whose daughter was vaccinated po with all three doses of ROTATEQ. On 02-Jun-2008 the patient's daughter experienced gastroenteritis rotavirus. On 04-JUN-2008 and on 05-JUN-2008 the patient complained of diarrhea and on 13-JUN-2008 there were no complaints. Subsequently, the patient recovered from diarrhea. This is one of several reports from the same source. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC, RV5
Symptoms: Pyrexia, Vomiting
Clinical narrative: Information has been received from a certified medical assistant concerning a 6 month old male on 01-FEB-2008, 28-MAR-2008 and 23-MAY-2008 was vaccinated po with the first, second and third 2.0 ml doses respectively ROTATEQ (first dose lot #657988/1193U, second dose lot # 660287/1877U and third dose lot # 660379/0144X). Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, ACTHIB, PREVNAR and amoxcillin. It was reported that on 27-MAY-2008 the patient experienced vomiting and an unspecified low grade fever. Treatment included dietary changes. There were no other symptoms or treatment reported. On 29-MAy-2008 the mother reported that the symptoms were resolving. The patient sought medical attention at an office visit. It was reported that the patient recovered (date unspecified). This is one of several reports from the same source. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal pain upper, Allergy test negative, Bronchiolitis, Cough, Decreased appetite
Clinical narrative: Information has been received from a certified medical assistant (CMA) and a physician concerning a 10 week old male twin who on 16-JAN-2008 was vaccinated po with the first 2.0 ml dose of ROTATEQ ( lot#65788/1193U). Concomitant vaccines included PEDIARIX, PREVNAR and ACTHIB. It was reported that on 22-JAN-2008 the patient experienced vomiting, it continued and was seen in the office on 25-Jan-2008 with some projectile vomiting and belly pain. Patient was seen in the office on 29-JAN-2008 with less appetite, increased sleeping and still spitting up. On 31-JAN-2008 patient was still vomiting, very fussy and afebrile. Intussusception was ruled out and vomiting and fussiness resolved. On 18-FEB-2008, the patient was seen in the office for congestion and was diagnosed with bronchiolitis, wet cough and wheezing. Patient was seen again on 19-FEB-2008, 21-FEB-2008 and 22-FEB-2008 in the office for the bronchiolitis. On 23-FEB-2008, the patient was reported to be doing better. On 25-FEB-2008 the patient was seen in the emergency room with bronchiolitis (was not admitted to the hospital). Allergy tests were negative and the patient was diagnosed with intermittent wheezing. The patient was placed on therapy with FLOVENT and albuterol prn. On 19-Mar-2008 patient was seen in the office and was reported as doing "great" and physician opted not to give the ROTATEQ. The outcome is reported as recovered. This is one of several reports from the same source. No additional information is expected.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Infantile spitting up, Irritability, Respiratory tract congestion, Somnolence, Vomiting
Clinical narrative: Information has been received from a certified medical assistant (CMA) and a physician concerning a 10 week old male twin who on 16-JAN-2008 was vaccinated po with the first 2.0 ml dose of ROTATEQ ( lot#65788/1193U). Concomitant vaccines included PEDIARIX, PREVNAR and ACTHIB. It was reported that on 22-JAN-2008 the patient experienced vomiting, it continued and was seen in the office on 25-Jan-2008 with some projectile vomiting and belly pain. Patient was seen in the office on 29-JAN-2008 with less appetite, increased sleeping and still spitting up. On 31-JAN-2008 patient was still vomiting, very fussy and afebrile. Intussusception was ruled out and vomiting and fussiness resolved. On 18-FEB-2008, the patient was seen in the office for congestion and was diagnosed with bronchiolitis, wet cough and wheezing. Patient was seen again on 19-FEB-2008, 21-FEB-2008 and 22-FEB-2008 in the office for the bronchiolitis. On 23-FEB-2008, the patient was reported to be doing better. On 25-FEB-2008 the patient was seen in the emergency room with bronchiolitis (was not admitted to the hospital). Allergy tests were negative and the patient was diagnosed with intermittent wheezing. The patient was placed on therapy with FLOVENT and albuterol prn. On 19-Mar-2008 patient was seen in the office and was reported as doing "great" and physician opted not to give the ROTATEQ. The outcome is reported as recovered. This is one of several reports from the same source. No additional information is expected.