chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Hyporeflexia, Muscle spasms, Muscular weakness, Myelopathy, Nuclear magnetic resonance imaging
Clinical narrative: The patient's problems started about 5 to 6 days ago when she started having some spasms in the back with some numbness, tingling in the legs. She did see a neurosurgeon who ordered MRI of the thoracic spine and the lumbar spine. This appeared to be essentially unremarkable, slight pinching of the sacral sac. While this was going on, she started having more and more weakness and numbness in the legs. She went to the emergency room. She was given pain medication and was sent home. She got worse, went to the emergency room and again was treated with pain medication Norflex and anxiety medication that seems to make her feel a little bit better. She went home and then was unable to walk unsteady. On examination she was found to have no deep tendon reflexes in the lower legs and sensory level to L1. Myelopathy or AIDP diagnoses was made and she was immediately admitted now with neurology consultation. Further work-up will be done here immediately. The patient who is well known to me has no previous neurological problems. She has been treated in the past for hypercholesterolemia but otherwise the labs essentially have been normal. She has been in good health. She is up-to date with her DEXA scan which shows mild osteopenia. She is very active. She had hysterectomy in 2002. Otherwise she has absolutely no medical or surgical problems. She does take vitamins at home. Otherwise, no other pertinent medical/surgical history. Within the last 24-48 hours she has also developed acute left facial palsy. She complains of marked tingling, numbness, hyperesthesias both legs as well as tips of her fingers.  02/19/2007 VAERS report received with accompanying medical records (H&P, labs and diagnostics).  Made call to hospital to see if D/C Summary had been dicated yet, it has not.  TC to admitting MD who stated D/C DX was the same: Acute GBS, Acute left Bells' Palsy.  HPI: Two and 1/2 weeks after receiving flu vax. pt. began having back spasms and numbness/tingling in the legs.  Two ER visits over several days resulted in tx. with pain  meds, muscle relaxers, and anti-anxiety medication. Finally presented to admitting MD when she was unable to walk properly, gait unsteady.  C/o marked numbness, tingling, hyperesthesias of both legs as well as the tips of her fingers PE: No DTRs in lower extremities. Sensory level to L1.  Sensation is lost to the groin.  Gait unsteady and shuffling. On approx. 2/10/2007 she developed acute left facial palsy. Admitted to IMCU for Stat work-up.  Transfered to rehab after 3 days. Admission DX:  1) Acute Guillain-Barre Syndrome, AIDP, r/o CIDP 2) Acute left Bell's Palsy.  (MD states D/C DX is the same.) Per information received from annual, residual sensory and motor neurological symptoms legs & back, otherwise almost complete recovery. Return to work period including rehabilitative physical therapy of almost 1 yr duration.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Laboratory test, Pregnancy, Systemic lupus erythematosus
Clinical narrative: Information has been received from a 26 year old female consumer with migraine headaches, who on approximately 31-OCT-2006 ("end of October or beginning of November 2006"), was vaccinated with the first dose of Gardasil (yeast). Concomitant therapy included propranolol HCL for migraine headaches. Subsequently, the patient "became pregnant at the end of November 2006," and reported " a normal pregnancy with no adverse side effects". The approximate LMP date was 30-NOV-2006, with an estimated due date of 06-SEP-2007. Additionally, on approximately 28-DEC-2006 ("approximately six weeks ago"), the patient was diagnosed with lupus (not further specified), and daily injections of LOVENOX were initiated as treatment. Unspecified blood tests were performed (results not reported). At the time of the report, the patient had not recovered. Upon internal review, the patient's diagnosis of lupus was considered to be an other important medical event. The patient sought unspecified medical attention. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Brain scan normal, Computerised tomogram normal, Condition aggravated, Dystonia, Pain
Clinical narrative: Information has been received from a health professional concerning a 14 year old female with allergies to Prozac and Seroquel and a history of dystonic reaction involving the right arm, right leg and neck in 2006 caused by an allergic reaction to Seroquel who on 12-JAN-2007 was vaccinated IM with a first dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified) and Prevacid. On 13-JAN-2007 the patient experienced a tic disorder involving her head and neck. The patient also had a rapid, involuntary, spasmodic dystonic reaction and torticollis like movement that appeared painful and continued during sleep. On 13-JAN-2007, the patient was examined in the emergency room and was given Benadryl and Ativan and was released. A CT scan of the brain was negative. On 15-JAN-2007, she was examined by her primary care physician and was given Benadryl IM. She was later examined on 15-JAN-2007 by a neurologist and was given Cogentin IM and was started on oral benztropine mesylate (MSD). ON 17-JAN-2007, 19-JAN-2007, and 05-FEB-2007, the patient was also examined by a neurologist. On 19-JAN-2007 the symptoms began to resolve and on 05-FEB-2007 completely resolved. The patient will continue with Cogentin until 19-FEB-2007. Tic disorder, rapid, involuntary, spasmic dystonic reaction and torticollis like movement were considered to be other important medical events and disabling. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Tic, Torticollis
Clinical narrative: Information has been received from a health professional concerning a 14 year old female with allergies to Prozac and Seroquel and a history of dystonic reaction involving the right arm, right leg and neck in 2006 caused by an allergic reaction to Seroquel who on 12-JAN-2007 was vaccinated IM with a first dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified) and Prevacid. On 13-JAN-2007 the patient experienced a tic disorder involving her head and neck. The patient also had a rapid, involuntary, spasmodic dystonic reaction and torticollis like movement that appeared painful and continued during sleep. On 13-JAN-2007, the patient was examined in the emergency room and was given Benadryl and Ativan and was released. A CT scan of the brain was negative. On 15-JAN-2007, she was examined by her primary care physician and was given Benadryl IM. She was later examined on 15-JAN-2007 by a neurologist and was given Cogentin IM and was started on oral benztropine mesylate (MSD). ON 17-JAN-2007, 19-JAN-2007, and 05-FEB-2007, the patient was also examined by a neurologist. On 19-JAN-2007 the symptoms began to resolve and on 05-FEB-2007 completely resolved. The patient will continue with Cogentin until 19-FEB-2007. Tic disorder, rapid, involuntary, spasmic dystonic reaction and torticollis like movement were considered to be other important medical events and disabling. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Skin lesion, Varicella
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated with a dose of ZOSTAVAX. Subsequently the patient developed chickenpox. The number of lesions was not specified. The patient may have possibly been hospitalized after the symptoms appeared. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARCEL
Symptoms: Adverse drug reaction, Biopsy skin, Rash pruritic, Rash vesicular, Secondary transmission
Clinical narrative: Information has been received from a physician's assistant (PA) concerning an 80 year old male with a history of lymphoma and chemotherapy who had close contact with a child who was vaccinated with a dose of VARIVAX. The PA reported that the patient subsequently developed a systemic itchy, vesicular rash. Unspecified medical attention was sought the patient was subsequently hospitalized for one week. A skin biopsy was done with a diagnosis of drug reaction. At the time of this report, the patient's systemic itchy vesicular rash persisted. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it present to identify if it is associated with the wild-type (WT) VZV strain or with the manufacturer vaccine reported VZV strain. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a physician concerning a 2 month old male with no medical history or allergies who on 06-FEB-2004 was vaccinated with an oral dose of Rotateq. There was no concomitant medication. On 07-FEB-2007, within 24 hours of vaccination, the patient developed bloody stools and was hospitalized. The patient's outcome was not reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a physician concerning two infants who on 06-FEB-2004 were vaccainted a dose of Rotateq. Within 24 hours after being vaccinated the patients developed bloody stools. They were not hospitalized. The patients outcomes were not reported. Upon internal review the patient's blood stools were considered to be other important medical events. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a female with no drug reactions of allergies and with reportedly immunosuppression due to multiple sclerosis, who on 06-FEB-2007 was vaccinated into the right deltoid with a 0.5ml dose of Pneumovax (lot #655152/0889F). The patient was concomitantly vaccinated with Dtap into the left deltoid. Concomitant medications included medications for multiple sclerosis. It was reported that the patient presented to the office yesterday (07-NOV-2007) with high fever 101, redness at the injection site which was the right deltoid, swelling measured 5 by 4 centimeters. The patient experienced extreme pain at the injection site and limited movement of her right arm due to the pain. The patient sought unspecified medical attention and was treated with oral antibiotic. The patient had a follow up visit and the site was 7 by 6 centimeters of redness, but the swelling had gone down and her temperature was 99.8. The injection site was less tender and the patient had more movement of the right arm. The reporter determined the patients high fever 101, redness at the injection site, swelling measured 5 by 1 centimeters, extreme pain at the injection site and limited movement of right arm due to pain were considered to be disabling and other important medical events. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a female with no drug reactions of allergies and with reportedly immunosuppression due to multiple sclerosis, who on 06-FEB-2007 was vaccinated into the right deltoid with a 0.5ml dose of Pneumovax (lot #655152/0889F). The patient was concomitantly vaccinated with Dtap into the left deltoid. Concomitant medications included medications for multiple sclerosis. It was reported that the patient presented to the office yesterday (07-NOV-2007) with high fever 101, redness at the injection site which was the right deltoid, swelling measured 5 by 4 centimeters. The patient experienced extreme pain at the injection site and limited movement of her right arm due to the pain. The patient sought unspecified medical attention and was treated with oral antibiotic. The patient had a follow up visit and the site was 7 by 6 centimeters of redness, but the swelling had gone down and her temperature was 99.8. The injection site was less tender and the patient had more movement of the right arm. The reporter determined the patients high fever 101, redness at the injection site, swelling measured 5 by 1 centimeters, extreme pain at the injection site and limited movement of right arm due to pain were considered to be disabling and other important medical events. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse concerning a female with a penicillin and aspirin allergy who was vaccinated with the first and second doses, respectively, of Recombivax HB. The RN reported that the patient developed a rash after receiving the first dose and was then hospitalized after the second dose. The RN did not know when the patient received the vaccine, but did state it was not within the last two years. The patient subsequently recovered. Additional information has been requested.
Age: 0.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Pt developed chickenpox
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Lymphadenopathy, Malaise, Pruritus, Rash macular, Vaccinia
Clinical narrative: Developed macular rash, malaise, pruritis and regional (axillary) lymphadenopathy 14 days following smallpox vaccination (e.g. generalized vaccinia).  Otherwise normal vaccination reaction.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, Oedema peripheral, Skin irritation
Clinical narrative: Swollen and irritation on the right leg. cry for 3 hrs.
Age: 41.0
Sex: M
Vaccine: MMR, TD
Symptoms: Hyperhidrosis, Lymphadenopathy, Malaise, Measles, Myalgia
Clinical narrative: Patient developed measles: the patient started noticing signs of sweating, myalgias, malaise, right auricular and bilateral inguinal lymphadenopathy.  At the same time a rash  broke out over his forehead and over his chest and expanded centrifugally. Dr. saw the patient and recommended supportive care with antipyretics, fluids, and ibuprofen for   pain.
Age: 41.0
Sex: M
Vaccine: MMR, TD
Symptoms: Rash
Clinical narrative: Patient developed measles: the patient started noticing signs of sweating, myalgias, malaise, right auricular and bilateral inguinal lymphadenopathy.  At the same time a rash  broke out over his forehead and over his chest and expanded centrifugally. Dr. saw the patient and recommended supportive care with antipyretics, fluids, and ibuprofen for   pain.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug exposure during pregnancy, Pregnancy
Clinical narrative: Patient into clinic on 1/18/07 for appointment. Patient not asked if she could be pregnant. Given varicella vaccine. Patient returned on 2/15/07 for another appointment. Discovered in appointment that patient is pregnant. Attending doctor noted at previous visit that patient had received varicella vaccine. Patient's est. GA  is about 24-25 weeks and has had no prenatal care. Dr. advised patient on theorictal risk, counselled about medicine labels for pregnancy precautions. Referral to prenatal clinic
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Rash
Clinical narrative: Received Tdap on 2/13/2007.  Reports developing a rash on 2/14/2007 around 3pm that started on left side of neck and has extended around neck and to upper chest.  Patient reports some minor itching.  Took Benadryl due to previous reactions with medications before.   Took no Benadryl on 2/15/2007.  Rash has not resolved.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Fatigue, Hypersomnia, Nausea
Clinical narrative: Several hours later developed diffuse joint pain, severe fatigue and nausea.  Slept for 16 hours.  Nausea and joint pain continued for 2 days, then resolved.
Age: 43.0
Sex: M
Vaccine: HEPA
Symptoms: Wrong drug administered
Clinical narrative: Soldier was to receive a Hepatitis B vaccine and received a Hepatitis A vaccine instead. Soldier had already completed his Hepatitis A series. Immunization record notes to Twinrix doses in the past and 3 Hep A doses.
Age: 0.2
Sex: F
Vaccine: HIBV, RV5, RV5
Symptoms: Culture stool positive, Diarrhoea, Haematochezia, White blood cell count normal
Clinical narrative: 10 DAYS AFTER PATIENT RECEIVED ROTA-TEQ VACCINE SHE BEGAN WITH MUCOUSY DIARRHEA.  MOTHER ALSO STATED A FEW DAYS AFTER THAT SHE SAW SPECKS OF RED IN STOOLS THOUGHT TO BE BLOOD.  STOOL CULTURE, O+P, WHITE CELLS WERE DONE, ALL WERE NEGATIVE.  NO TREATMENT WAS DONE, PATIENT WAS REFERRED TO PEDI-GI FOR EVALUATION.
Age: 0.2
Sex: F
Vaccine: HIBV, RV5, RV5
Symptoms: Culture stool negative, Diarrhoea, Diarrhoea haemorrhagic, Haematochezia
Clinical narrative: 10 DAYS AFTER PATIENT RECEIVED ROTA-TEQ VACCINE SHE BEGAN WITH MUCOUSY DIARRHEA.  MOTHER ALSO STATED A FEW DAYS AFTER THAT SHE SAW SPECKS OF RED IN STOOLS THOUGHT TO BE BLOOD.  STOOL CULTURE, O+P, WHITE CELLS WERE DONE, ALL WERE NEGATIVE.  NO TREATMENT WAS DONE, PATIENT WAS REFERRED TO PEDI-GI FOR EVALUATION.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Laboratory test, Mobility decreased, Muscular weakness
Clinical narrative: Onset of arthritic type pain in R arm/hand which moved to L hand arm several weeks later.  After hand symptoms subsided, same type of pain began in legs, first right then left.  Pain then moved to hips, at times severe enough that climbing stairs was difficult.  Symptoms have subsided for the most part.  Slight muscle weakness noted during worst of the pain.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Pt received DTaP and MMRV in the left arm on 2/12/07.  On 2/13/07 pt started with fever and redness at the site of injection.  On 2/15 fever was still present, up to 104 and the redness on the left arm still 1in by 3 inches, no streaking.  No other symptoms besides fever.  Treated with Tylenol and ice to the area.  Told to come into the clinic on 2/16 to have the arm looked at to see if it is an infection, pt called and cancelled appt and said he was getting better on 2/16.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Oedema peripheral
Clinical narrative: Mom called 2 days after child received DtaP in left thigh to report that child's left thigh was larger than right one. Reported that leg was swollen from his "knee up" and was about 1 1/4th to 1 1/2 times the size of the right one. Denies elevated temperature or any other involvement other than tenderness and redness. Mom was instructed to give Tylenol/Advil for tenderness, monitor for worsening of symptoms and to report event to physician at next ofice visit or sooner if does not resolve. Mom verbalized understanding and agreement.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, HEPA, HIBV, IPV, MMR, PNC
Symptoms: Injection site pain, Oedema peripheral, Pain in extremity
Clinical narrative: RIGHT ARM SWOLLEN AROUND THE SHOULDER. ARM HURTS TO MOVE UPWARD, AND TO TOUCH ON THE SITE OF THE INJECTION. NO FEVER, DUE TO RECEIVE MOTRIN EVERY SIX HOURS AFTER SHOTS GIVEN.
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Chills, Pharyngitis streptococcal, Pyrexia, Rash pruritic, Vomiting
Clinical narrative: Client received first pre-exposure rabies vaccine on 02/09/07. On 02/15/07 clients instructor  notified us that client would not return for completion of series due to a possible reaction. Instructor reported that client said   that evening she experienced rash with itching on her body, and within 12-24 hours fever, vomiting, and chills.  Instructor indicated client did not say what temperature was. Client contacted and was seen by a physician who told her she had strep throat and advised her to not take any further rabies vaccine as this may be a reaction.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Erythema, Pyrexia, Skin warm, Swelling
Clinical narrative: 2/15/07 AWAKENED WITH SOME HIGH TEP:MOTHER NOTED SOME REDDESH COLOR ON LEFT DELTOID AREA (ABOUT 6MM). AS DAY PROGRESSED AREA ENLARGED.  AREA WAS WARM TO TOUCH.  THIS A.M. 2/16/07 AREA SOME WHAT LARGER THAN LAST EVENING. STILL WARM TO TOUCH, CHILD HAS NO COMPLAINT OF HIGH FEVER, BUT, STATES ARM IS SRILL SOME WHAT ENCOMFORTABLE. CHILD "STATES HE FEELS FINE"
Age: 40.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Induration, Wrong drug administered
Clinical narrative: Patient in clinic on 02/14/2007 for MMR, but received MMRV in error.  Patient returned on 02/16/2007 with redness and induration measuring 80mm x 65mm.  Patient reports no other adverse reactions such as fever, hives, pain, etc.  Patient had no history of chickenpox or previous varicella vaccinations.
Age: 0.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Rhinorrhoea, Wheezing
Clinical narrative: AFTER RECIVING VARICELLA VACCINE, ABOUT FIVE MINUTES LATER DEVELOPED WHEEZING, ITCHING, DIFFUSE SKIN ERYTHEMA.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Blood lead normal, Dizziness, Oxygen saturation normal, Vital capacity normal
Clinical narrative: Pt became dizzy, PB dropped, Sat remained 99% in R/A. Lungs clear, no wheezing noticed. Recovered in 10 min. Vital sign normal prior to discharge. Refused to go to ER.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre Syndrome.  3/1/07 Received medical records from PCP which reveals patient experienced Lymes disease in 7/05 after receiving multiple mosquito bites at summer camp in NY.  Fever of 102, blotchy rash & fatigue.  Treated w/antibiotics.  In 10/06, felt Lymes worsening & eval by ortho included MRI of shoulder & cspine. which were reported as WNL.  Saw neuro also & EMG of UE & LE reported as WNL.  PCP note of 11/06 states neuro now thinks GBS & weakness had improved.  By 2/07 was symptom free w/resolved muscle weakness. 3/30/07 Received medical records from neurologist which reveal patient was initially evaluated on 10/23/06 after experienced weakness of bilat UEs.  Weakness had started approx 2-3 wks prior when he noted having difficulty raising his arm & had pain in sides of his neck radiating to shoulders bilat when turned head to that particular side.  Neuro exam revealed gen weakness of shoulder abductors & hip flexors.  DTRs were absent in UEs & right knee and decreased in left knee & both ankles.  EMG/NCS done that day revealed decreased recruitment suggesting central process.  MRI of brain & c-spine was to be reviewed.  Returned to office on 11/2/06.  MRI was read as WNL.  Strength had improved but right remained weaker than left arm.  It was felt that his constellation of s/s was suggestive of GBS, resolving spontaneously.  Returned to office on 11/13/06 & continued to improve & regain strength.  He was d/c from neuro f/u at that point & permitted to return to sports.  No EMG/NCS report was included with records. FINAL DX: acute inflammatory polyradicular neuropathy (GBS). 4/5/07 Per direction of CDC: Please change the lot # that was entered for VAERS # 272473. It was reported incorrectly. The correct lot # for the Menactra given was U2108AA.  Please correct this is the VAERS database.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site haemorrhage, Myalgia, Pyrexia
Clinical narrative: Pt seen in office the day after vaccine with fever (99.2), headache, some muscle aches, and a mild ecchymotic reaction at injection site.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Irritability
Clinical narrative: Prolonged (5hours or more) profound irritability, high pitched inconsolable cry, syxs waning by 9 hours post injection.
Age: 14.0
Sex: F
Vaccine: UNK
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Left arm redness, swelling surrounding site of injection. Treating for cellulitis with antibiotics.
Sex: U
Vaccine: RV5
Symptoms: Choking, Incorrect dose administered, No adverse effect, Vaccination complication
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient was vaccinated with a dose of Rotateq. The LPN reported that the patient choked and spit some of the vaccine out causing some of the vaccine to go into the medical assistant's eyes. It was unknown if medical attention was sought and no other symptoms were noted.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a health professional concerning a 4 month old infant who on 20-Oct-2006 was vaccinated with an oral first dose of Rotateq (lot 655175/0849F). The patient was not experiencing any known symptoms. 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
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 2-month-old female who on 08-Jul-2006 was vaccinated PO with a 2.0 ml dose of Rotateq. There was no concomitant therapy. The physician reported that on 14-Jul-2006, the patient developed severe diarrhea. Unspecified medical attention was sought. On 15-Jul-2006, the patient's severe diarrhea resolved. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Cough, Wheezing
Clinical narrative: Information has been received from a physician concerning a 2-month-old male who in December 2006, was vaccinated PO with the first dose of Rotateq. The physician reported that, later that same night, in December 2006 the patient developed wheezing and a cough. The patient was taken to the emergency room, but was not hospitalized. The patients wheezing and cough subsequently resolved. The physician felt that the wheezing and cough were probably a reaction to Rotateq. Additional information has been requested.
Age: 0.22
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 2-month-old female on 30-Oct-2006 was vaccinated PO with the first 2.0 ml dose of Rotateq. Concomitant vaccinations administered on that same day included a dose of Prevnar, a dose of Pediarix, a dose of PedvaxHib. Other concomitant drug therapy included amoxicillin. The physician reported that on 31-OCT-2006, the patient developed severe diarrhea three times daily. Unspecified medical attention was sought. On 03-NOV-2006, the patient's diarrhea resolved. Additional information has been requested.
Age: 0.16
Sex: M
Vaccine: HIBV, PNC, RV5
Symptoms: Rash, Viral rash
Clinical narrative: Information has been received from a physician concerning a 60-day-old male twin who on 26-DEC-2006 was vaccinated PO with the first 2.0 ml dose of Rotateq (Lot # 655483/1116F). Concomitant vaccinations on that same day included a dose of Prevnar (Lot #B08655A) and the first IM dose of PedvaxHib (Lot #6543399/0785F). There was no illness at the time of developed a rash on his trunk, face and legs. Unspecified medical attention was sought. No laboratory/diagnostic tests were performed. A diagnosis of viral exanthema was made. The physician reported that on 26-DEC-2006, the patient developed a rash on his trunk, face and legs. Unspecified medical attention was sought. On 29-DEC-2006, the patient's rash resolved. The physician noted that the patient would receive additional doses of Rotateq. Additional information is not expected. On morning of 28-DEC-2006 (previously reported as 26-DEC-2006), the patient developed a rash on his trunk, face and legs. On 29-DEC-2006 (previously reported as 27-DEC-2006), the patient viral exanthema resolved. Additional inforamtion is not expected.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a health professional concerning a 6 month old patient who was vaccinated with a first dose of Rotateq. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 19 week old male who on 09-JAN-2007 was vaccinated with an oral second dose of Rotateq. it was reported that the second dose was administered 11 weeks after the first dose. No problems were reported. Medical attention was not sought. There was no product quality complaint involved.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Rash papular
Clinical narrative: Information has been received from a physician concerning a 2-month-old male who in January 2007, was vaccinated PO with the first 2.0 ml dose of Rotateq. Concomitant vaccinations administered on the same day included a dose of Pediarix. The physician reported that on 08 Jan-2007, the patient developed a rash. Unspecified medical attention was sought, but no laboratory/diagnostic tests were performed. At the time of this report, the patient's rash persisted. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 2/13/2007.  Information has been received from a physician concerning a 8-week-old Hispanic male with no medical history who on 08-JAN-2007, at 10:00, (previously reported as January 2007), was vaccinated PO with the first 2.0 mL dose of ROTATEQ (Lot #654970/0777F).  Concomitant vaccinations administered on that same day and time included the first IM dose in the right leg of PEDIARIX (Lot #AC21B079AA), the first IM dose in the left leg of ACTHIB and the first IM dose in the left leg of PREVNAR (Lot #B08675C).  There was no illness at the time of vaccination.  The physician reported that on 09-JAN-2007, at 11:00, (previously reported as 08-JAN-2007), the patient developed an erythematous papular rash all over his body.  The patient was seen by the physician, but no laboratory/diagnostic tests were performed.  On 19-JAN-2007, the patient's rash resolved.  Additional information is not expected.
Age: 0.59
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a registered nurse concerning a 6-month-old patient who on 24-AUG-2006 and 10-JAN-2007 was vaccinated PO with the first and second doses, respectively, of Rotateq. It was unknown if medical attention was sought. No problems were reported. Additional information has been requested.
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a consumer concerning her 6-week-old grandson with no medical history or allergies who on 03-Jan-2007 was vaccinated with the first dose of Rotateq. There was no concomitant therapy. On 03-JAN-2007, the patient developed diarrhea and vomiting. Unspecified medical attention was sought, but no laboratory/diagnostic test were performed. In January 2007, the patient recovered from the diarrhea and vomiting. No further information is available.
Age: 0.25
Sex: U
Vaccine: RV5
Symptoms: Gastroenteritis rotavirus, HIV antibody positive, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning a 3 month old HIV positive patient who was vaccinated with a first oral dose of Rotateq. One week post vaccination the patient experienced rotavirus gastroenteritis (rota test performed). Unspecified medical attention was sought. The patients outcome was not known. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with a first dose of Rotateq. Subsequently the patient developed fever and diarrhea. Unspecified medical attention was sought. The patients outcome was unknown. There was no product quality complaint involved. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a physician concerning a 4-month-old patient who was vaccinated with the first dose of Rotateq. Unspecified medical attention was sought and no problems reported. 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 was vaccinated with a first dose of Rotateq. It was reported that it had been 16.5 weeks (also reported as 6.5 weeks) since the first dose and the patient was to received a second dose on 13-JAN-2007. It was noted that the patient was doing fine. So product quality complaint was involved. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 2 month old female who on 18-DEC-2006 was vaccinated with a 2ml oral dose of Rotateq. Concomitant vaccinations administered that day included a dose of Comvax, ad dose of Dtap, Polio and a dose of Prevnar. Later the day the patient experienced on or more episodes of vomiting. Subsequently, the patient recovered. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Oral mucosal blistering, Pain
Clinical narrative: Information has been received from a physician concerning an approximately 2 month old male who on 04-JAN-2007 was vaccinated PO with a first dose of rotavirus.  On 05-JAN-2007 the patient developed painful blisters in his mouth.  The patient recovered on 08-JAN-2007.  Unspecified medical attention was sought.  There was no product quality complaint involved.  Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning a 8 week old female who on 10-OCT-2006 was vaccinated with a 2 mL PO dose of rotavirus. There was no concomitant medication. On 10-OCT-2006 the patient vomited the medication and stomach contents.  The baby had just been fed before administration of the vaccine.  Subsequently, the patient recovered.  It was noted that two months later the infant tolerated the next dose of the vaccine.  There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Retching
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a 2 ml dose of rotavirus.  It was reported that the patient gagged because the "vaccine is too thin'.  Medical attention was sought.  There was no product quality complaint involved.  Additional information has been requested.
Age: 0.27
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a registered nurse concerning a 14 week old female who on 22-Nov-2004 was vaccinated with a first dose of Rotateq (human-bovine) (lot# "0942"). The patient was not experiencing any problem post vaccination. Unspecified attention was sought. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Ear infection, Nasopharyngitis
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a child who on 14-JUN-2006 and 15-AUG-2006 was vaccinated PO with the first and second dose, respectively, of Rotateq (human-bovine). The LPN reported that the patient subsequently developed diarrhea, an ear infection and a cold. Unspecified medical attention was sought. It was noted that the third dose of Rotateq (human-bovine) was not given at the recommended schedule due to the child's events (no symptoms noted from not getting 3rd dose at recommended schedule). At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 0.08
Sex: U
Vaccine: DTAPHEPBIP, HIBV, RV5
Symptoms: Body temperature increased
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 6 week old patient with no allergies who in December 2006, was vaccinated PO with the first dose of Rotateq (human-bovine). Concomitant vaccinations administered on that same day included a dose of Pediarix and a dose of PedvaxHIB. The RN reported that in December 2006, the patient experienced an elevated temperature. Unspecified medical attention was sought. At the time of this report, the patient was noted to be recovering. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Gastrooesophageal reflux disease
Clinical narrative: Information has been received from a physician concerning PO with the second dose of Rotateq (human-bovine). Concomitant therapy included ZANTAC and PREVACID. The physician reported that on approximately 04-JAN-2007, within five hours of being vaccinated, the patient developed GERD. Unspecified medical attention was sought. No laboratory/diagnostic tests were performed. At the time of the report, the patient was noted to be recovering. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Gastrooesophageal reflux disease
Clinical narrative: Information has been received from a physician concerning a 2-month-old female who on approximately 04-JAN-2007 was vaccinated PO with the first dose of Rotateq (human-bovine). The physician reported that on approximately 04-JAN-2007, within eight hours of being vaccinated, the patient developed GERD. Unspecified medical attention was sought. No laboratory/diagnostic tests were performed. At the time of this report, the patient was noted to be recovering. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a patient who on 13-AUG-2006 and 03-NOV-2006 was vaccinated PO with the first and second doses, respectively of Rotateq (human-bovine). The physician reported that the patient did not receive the third dose due to illness. It was unknown if medical attention was sought. At the tome of this report, the outcome was unknown.
Age: 0.35
Sex: M
Vaccine: RV5
Symptoms: Blood electrolytes abnormal, Diarrhoea, Fluid replacement, Full blood count
Clinical narrative: Information has been received from a physician concerning an 18 week old male, with no medical history and no allergies, who on 13-JAN-2007 was vaccinated with a second 2ml oral dose of Rotateq (lot #655175/0849F). there was no concomitant medication. On 17-JAN-2007 the patient developed diarrhea. The patient's mother called the physician on 21-JAN-2007 to say that the child still had watery stools. The patient was admitted to the hospital on the evening of 21-JAN-2007 and was given intravenous fluids to prevent dehydration. At the time of the report the patient was recovering but was still in the hospital. The patient's diarrhea was also considered to be an other important medical event by the reporter as he had to receive intravenous fluids. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a health professional concerning a patient who on 01-DEC-2006 was vaccinated with a first 2 ml oral dose of Rotateq (human-bovine). On 02-DEC-2006 the patient was vaccinated with a second 2 ml oral dose of Rotateq (human-bovine). No adverse experience was related to this event. No other information was provided. Additional information has been requested.
Age: 0.35
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a licensed visiting nurse (LVN) concerning a 17-week-old patient who on 19-JAN-2007 was vaccinated PO with the first 2.0 ml dose of Rotateq (human-bovine) (Lot#654969/1016F). It was unknown if medical attention was sought. No adverse experience was reported. Additional information has been requested. This was reported as there was a concern from the patient's mother as a sibling of the patient's developed Steven Johnson Syndrome secondary to medications not vaccine. additonal information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a first dose of rotavirus vaccine. On 06-NOV-2006, eleven weeks after the first dose, the patient came into the office for the second dose. The physician decided not to administer the second dose. No product quality complaint was involved.  No other information was provided. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This is in follow-up to report (s) previoulsy submitted on 2/13/2007. Information has been received from a registered nurse (RN) concerning a 6-month-old patient who was vaccinated with the 2nd dose of rotavirus vaccine after receiving the first dose at 2 months of age.  It was unknown if medical attention was sought.  Additional information has been requested. Follow information was received from the RN who indicated that the 6-month-old was never vaccinated with the second dose. There was no adverse event. Therefore WAES #0701USA04098 will be deleted from our files for ROTATEQ. Additional information has been requested.
Age: 0.25
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a physician concerning an approximately 3-month-old male with a history of stomach problems who in approximately October 2006, was vaccinated PO with the first 2.0 mL dose of rotavirus vaccine.  The physician reported that in approximately October 2006, the patient developed diarrhea and vomiting. Unspecified medical attention was sought and the patient subsequently recovered.  In December 2006, at approximately 5 months of age, the patient was vaccinated with the second 2.0 mL dose of rotavirus vaccine and again developed diarrhea and vomiting.  The patient subsequently recovered.  It was noted that the patient would not be getting the third dose.  Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 9-week-old female who on 15-SEP-2006 was vaccinated with second mL dose of rotavirus vaccine.  The physician reported that on 16-SEP-2006, the patient developed severe diarrhea. Unspecified medical attention was sought.  No laboratory/diagnostic tests were performed. On 24-SEP-2006, the patient's diarrhea resolved.  Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Irritability
Clinical narrative: Information has been received from a physician concerning a 2-month-old patient who was vaccinated PO with first 2.0 mL dose of rotavirus vaccine.  The physician reported that the patient subsequently became irritable with symptoms of diarrhea.  Unspecified medical attention was sought.  At the time of this report, the outcome was unknown.  Additional information has been requested.
Age: 0.47
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a female who in January 2007, was vaccinated with the second dose of rotavirus vaccine. The physician reported that in January 2007, the patient developed diarrhea.  It was unknown if medical attention was sought.  At the time of this report, the outcome was unknown.  Additional information has been requested.
Age: 0.54
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a nurse concerning a 2-month-old female who on 01-DEC-2006 was vaccinated PO with the first 2.0 mL dose of rotavirus vaccine. The nurse reported that on 02-DEC-2006, the patient developed diarrhea.  Unspecified medical attention was sought.  On 05-DEC-2006, the patient's diarrhea resolved. It was note that the patient did not receive the second dose of rotavirus vaccine. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 9-week-old white female with a probable mix protein allergy who on 28-NOV-2006, at 1700, was vaccinated PO with the first dose of rotavirus vaccine.  Concomitant vaccines administered on that same day and time included the first IM dose of Pediarix, the first dose IM dose of ActHib (lot#VE965AA) and the first IM dose of Prevnar. There was no illness at the time of vaccination. The physician reported that on 30-NOV-2006, the patient developed vomiting and diarrhea.  No laboratory/diagnostic tests were performed as medical attention was not sought. No adverse consequences, hospitalization or IV fluids were required.  Subsequently, the patient recovered from the vomiting and diarrhea.  No further information is available.
Age: 1.83
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a health professional concerning a 22 month old patient who was vaccinated with a first dose of rotavirus vaccine. No product quality complaint was involved. No other information was provided.  Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a health professional concerning a 12 month old patient who was vaccinated with a first dose of rotavirus vaccine.  No product quality complaint was involved. No other information was provided.  Additional information has been requested.
Age: 0.87
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a health professional concerning a 19 month old patient who was vaccinated with a third dose of rotavirus vaccine. No product quality complaint was involved.  No other information was provided.  Additional information has been requested.
Age: 0.42
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a health professional concerning a 5 month old patient who was vaccinated with a first dose of rotavirus vaccine. No product quality complaint was involved. No other information was provided.  Additional information has been requested.
Age: 0.58
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a health professional concerning a 2 month old patient who was vaccinated with a first dose of rotavirus vaccine. No product quality complaint was involved. No other information was provided.  Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 68 year old female with no known allergies who on 29-DEC-2006 was vaccinated SC with a 0.5 ml dose of varicella-zoster vaccine.  "Within 24 hours", on 30-DEC-2006 the patient developed an injection site reaction. The patient's symptoms included local heat, redness, pain and itching. Unspecified medical attention was sought.  At the time of the report the symptoms continued and the patient had not recovered.  There was no product quality complaint involved.  No further information was available.  Additional information has been requested. The patient had allergies to losartan potassium (WAES # 073USA00372)and hydrochlorothiarde (+) losartan potassium (WAES #0703USA00373).