chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Ultrasound scan normal, Vomiting projectile, Weight decreased, X-ray normal
Clinical narrative: 4 days after receiving Rotateq patient developed projectile vomiting with each feeding. The patient was seen 7 days after recieving Rotateq and was well hydrated but had a 1 pound weight loss. He was evaluated for pyloric stenosis and obstruction. An Ultrasound and obstruction series was negative. His feeds were limited to 1 ounce per hr for 12 hours and then advanced slowly over 72 hours. Today, 11 days post vaccination he is taking his usual amount of feedings with no problems. He gained back 3 ounces and his exam is normal.
Age: 0.17
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Eczema, Erythema, Rash
Clinical narrative: Mom says she broke out with a quarter size rash, approx. 8 spots on back, 3 on abdomen, and one on the top of her foot.The spots were red and dry. After the next set of vaccines she had the same rash only the spots were dthe size of a mosquito bite.The 3rd visit she only had a Dtap and her 4th visit she had only a Prenar shot. Her pediatrician feels it is eczema and not the vaccines, but mother wants it reported because sshe feels there is a connection. She does want the vaccines, but does not want to persue them at this time until she can get more information.
Age: 23.0
Sex: F
Vaccine: YF
Symptoms: Fatigue, Feeling abnormal, Full blood count normal, Headache, Laboratory test normal
Clinical narrative: A few hours after the yellow fever injection the patient felt extremely tired for 3-4 days.  Patient also report headaches in front of head and on top of head.  Headaches would come and go every few hours.  Eventually the headaches have made the patient miserable most of the day.  Patient continues to feel "foggy" and increased amount of headaches.  Patient has taken acetimenophen.  It takes a long time to take effect, and then does not work well. Patient requests immediate contact with CDC/vaccine manufacturer.
Age: 23.0
Sex: F
Vaccine: YF
Symptoms: Thyroid function test normal
Clinical narrative: A few hours after the yellow fever injection the patient felt extremely tired for 3-4 days.  Patient also report headaches in front of head and on top of head.  Headaches would come and go every few hours.  Eventually the headaches have made the patient miserable most of the day.  Patient continues to feel "foggy" and increased amount of headaches.  Patient has taken acetimenophen.  It takes a long time to take effect, and then does not work well. Patient requests immediate contact with CDC/vaccine manufacturer.
Age: 31.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Feeling abnormal, Heart rate increased, Hypoaesthesia oral
Clinical narrative: Client waited 15 min.after Tdap and Hep A inj. before leaving clinic. No adverse effects noted @ this time.Client returned to clinic @ 245pm with wife. Reports driving after shots and experienced increased heart rate and numb tongue.Client called wife who called dr. and advised to go to ER for evaluation. Client declined and came back to clinic with wife. Told client no physician was on staff and should go to ER. CLient declines again. Asked client if still had symptoms as reported earlier. Client states heart rate seems normal and tongue was no longer numb. Asked client if he had or was having symptoms of shortness of breath or breathing difficulties. Client states no but states still "feels weird". Asked client if has PCP, no. Advised client to go to urgent care for evaluation as clinic did not have a physician to evaluate client. Client's wife states will take client to facility for evaluation.
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Feeling hot, Lip swelling, Urticaria
Clinical narrative: On 5/9/08, pt started feeling weakness and felt feverish but no temperature was taken. Hives started on 5/10/08. Patient was examined on 5/12/08 and had welts on trunk and extremities, along with swollen lips.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Blood alkaline phosphatase increased, Blood culture negative, Blood glucose increased, Full blood count, Laboratory test
Clinical narrative: On 5-8-08 she received HIB, Prevnar, MMR and Varicella vaccine at noon.  On 5-10-08 at 6 PM she developed a fever of 100.0 rectally.  "A few hours later" per mom it was 104.0 rectally.  She was taken to ER where labs were drawn.  No difinite diagnosis was made - "could be from the shots".  Temp remained 100 rectal during the day and highter at night - 103.7 on 5-12-08.  Temp broke on 05-14-08.  Back to normal on 05-16-08.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Lymphocyte percentage increased, Neutrophil percentage, Pyrexia
Clinical narrative: On 5-8-08 she received HIB, Prevnar, MMR and Varicella vaccine at noon.  On 5-10-08 at 6 PM she developed a fever of 100.0 rectally.  "A few hours later" per mom it was 104.0 rectally.  She was taken to ER where labs were drawn.  No difinite diagnosis was made - "could be from the shots".  Temp remained 100 rectal during the day and highter at night - 103.7 on 5-12-08.  Temp broke on 05-14-08.  Back to normal on 05-16-08.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Lymphadenopathy, Pyrexia, Rash, Vaccinia
Clinical narrative: Began with lymphadenopathy and fever, then progressed to a rash under immunized arm with surrounding upper chest, back and both arms.
Age: 75.0
Sex: M
Vaccine: HEP
Symptoms: Confusional state, Hyperhidrosis, Hypertension, Pyrexia, Wheezing
Clinical narrative: wheezing, fever, up to 104F; sweats, frank confusion, hypertension
Age: 72.0
Sex: U
Vaccine: PPV
Symptoms: Dyspnoea, Pyrexia
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized for fever and progressive dyspnea. Vaccination took place on 4/14/2008 and hospital admission was on 5/09/2008. According to the physician, relationship to treatment is 'None'. We would be happy  to forward the Study's SAE Report Form upon request.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Developed scratching, redness, swelling, tightness/tautness left arm from elbow to shoulder.  No fever. Gave Benadryl, and Motrin alternating with Tylenol. Next morning swelling, itching, soreness were all diminishing.  Instructed to call Health Dept. if more problems.  We will check with Med Dir re: further immunizations and get back with Mom.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Scratch
Clinical narrative: Developed scratching, redness, swelling, tightness/tautness left arm from elbow to shoulder.  No fever. Gave Benadryl, and Motrin alternating with Tylenol. Next morning swelling, itching, soreness were all diminishing.  Instructed to call Health Dept. if more problems.  We will check with Med Dir re: further immunizations and get back with Mom.
Age: 0.3
Sex: M
Vaccine: PNC
Symptoms: Urticaria, Wrong drug administered
Clinical narrative: My baby broke out in terrible looking hives, and he was taken to hospital emergency room, and was given a steroid dose of 5ml and a referral to a pediatrician.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Nausea, Tremor, Vertigo
Clinical narrative: Vaccine Admin. at 10:30 AM. Pt called the office at 1:00PM with complaints of nausea, shakiness, vertigo and SOB. Pt told to go to ER & call PMD. Pt went to Medical Center and was treated with Prednisone, Benadryl and Xanax(all of this per pt). At approx. 2pm pt called back and talked to RN..pt feeling much better after ER visit and treatment given.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Lip swelling, Throat tightness
Clinical narrative: lightheaded, puffy lips, throat tightness
Age: 20.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: CLT'S MOTHER WHO IS THE CLT'S GUARDIAN REPORTED THAT SHE TOOK HER SON TO THE BARBER SHOP FOR A HAIR CUT ON 5/7/08 WHEN SHE NOTICED HE HAD "PIMPLE LIKE" SPOTS ON HIS HEAD APPROXIMATELY 1:00PM. SHE THEN CHECKED HIS NECK AND FOUND 2 MORE SIMILAR SPOTS THERE TOO. ON 5/9/08 CLT'S MOTHER REPORTED THAT THE "SPOTS" HAD SPREAD TO HIS BODY TO HIS CHEST, BACK AND ARMS. CLT'S MOTHER DESCRIBED "SPOTS" AS HAVING A "WHITE HEAD" ON SOME OF THEM. CLT'S MOTHER DENIES ANY FEVER WITH "SPOTS" AND THAT THE "SPOTS" DID ITCH AND SCABBED OVER.  CLT'S MOTHER REPORTED THAT THE SYMPTOMS LASTED APPROXIMATELY 5 DAYS AND THAT CLT IS NO LONGER ITCHING AND THE "SPOTS" ARE HEALING (ONLY PINKISH SPOTS LEFT ON SKIN).  CLT'S MOTHER REPORTS SHE WAS UNABLE TO TAKE CLT TO HIS PRIVATE PHYSICIAN BECAUSE SHE WAS GOING OUT OF TOWN.  CLT'S MOTHER RERPORTED THAT SHE PLACED CALAMINE LOTION ON "SPOTS" AND THAT CLT WAS ALREADY TAKING ORAL BENADRYL WITH MEDICATIONS HE TAKES ON A DAILY BASIS TO PREVENT SIDE EFFECTS OF THOSE MEDICATIONS. THE OFFICE OF DR. CALLED TO ORIGINALLY REPORT TO HEALTH DEPARTMENT ADVERSE REACTION THAT MOTHER HAD CALLED INTO THEM.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Antibody test negative, Blood culture negative, CSF test normal, Crying, Culture urine negative
Clinical narrative: One day after administration of her 2 month vaccines the patient began taking less feeds and had decreased interaction with family.  She was noted to have episodes where she would stare off into space followed by jerking of her arms and then begin crying.  These episodes occured once the day following her vaccines and then twice 2 days following her vaccines.  Mother also reported a low grade fever of 100.9, loose stools and emesis.  The patient was admitted received a full rule out sepsis w/u as well as evaluation for etiology of seizure.  Her work up was negative and she was discharged to home without medications.7/15/08-records received for DOS 3/26/08-not acting like self. Screaming. Legs swollen secondary to vaccinations. Loose stools, emesis increase in spit up, drooling. Temp 100.9 (R). Staring, tremble and jerks arm. Fever, irritability possible seizures.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Dyskinesia, Nuclear magnetic resonance imaging brain normal, Oral intake reduced, Polymerase chain reaction
Clinical narrative: One day after administration of her 2 month vaccines the patient began taking less feeds and had decreased interaction with family.  She was noted to have episodes where she would stare off into space followed by jerking of her arms and then begin crying.  These episodes occured once the day following her vaccines and then twice 2 days following her vaccines.  Mother also reported a low grade fever of 100.9, loose stools and emesis.  The patient was admitted received a full rule out sepsis w/u as well as evaluation for etiology of seizure.  Her work up was negative and she was discharged to home without medications.7/15/08-records received for DOS 3/26/08-not acting like self. Screaming. Legs swollen secondary to vaccinations. Loose stools, emesis increase in spit up, drooling. Temp 100.9 (R). Staring, tremble and jerks arm. Fever, irritability possible seizures.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia, Social avoidant behaviour, Staring, Vomiting
Clinical narrative: One day after administration of her 2 month vaccines the patient began taking less feeds and had decreased interaction with family.  She was noted to have episodes where she would stare off into space followed by jerking of her arms and then begin crying.  These episodes occured once the day following her vaccines and then twice 2 days following her vaccines.  Mother also reported a low grade fever of 100.9, loose stools and emesis.  The patient was admitted received a full rule out sepsis w/u as well as evaluation for etiology of seizure.  Her work up was negative and she was discharged to home without medications.7/15/08-records received for DOS 3/26/08-not acting like self. Screaming. Legs swollen secondary to vaccinations. Loose stools, emesis increase in spit up, drooling. Temp 100.9 (R). Staring, tremble and jerks arm. Fever, irritability possible seizures.
Age: 1.25
Sex: F
Vaccine: HEPA
Symptoms: Body temperature increased, Oedema peripheral, Rash generalised, Skin discolouration, Swelling face
Clinical narrative: Rash dev. all over body 3 hrs after immunization given on 5/14/08. Temp of 99.1, puffy to face and feet. daycare reported was had blueish tint. Benedryl ws adm. by mom on 05/16/08.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site rash
Clinical narrative: Pt had a local rash at the site of her MMR injection. Mom noticed the rash the next morning after injection.
Sex: U
Vaccine: HEPAB
Symptoms: Erythema multiforme
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of erythema multiforme in an adult subject of unspecified gender who was vaccinated with Twinrix (GlaxoSmithKline).  In 2008 the subject received unspecified dose of Twinrix at 1.0 ml.  At an unspecified time after vaccination with Twinrix, the subject experienced erythema multiforme and a systemic reaction.  This case was assessed as medically serious by GSK.  At the time of reporting the outcome of the events was unspecified.  The physician considered the events were probably related to vaccination with Twinrix.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Gait disturbance, Injection site nodule, Oedema peripheral, Pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling of legs in a 4-year-old female subject who was vaccinated with INFANRIX(GlaxoSmithKline). Previous and/or concurrent vaccination included INFANRIX; GlaxoSmithKline; intramuscular given on an unspecified date; HAVRIX; GlaxoSmithKline; intramuscular, left thigh given on 26 April 2008; Ipol; Aventis Pasteur; unknown given on 26 April 2008; MMR II; Merck; unknown given on 26 April 2008; MMR II; Merck; unknown given on 26 April 2008. On 26 April 2008 the subject received 5th dose of INFANRIX (.5 ml, intramuscular, left thigh). On 28 April 2008, two days after vaccination with INFANRIX, the subject experienced swelling of legs, nodule at injection site, redness, painful to walk and pharmaceutical product complaint. The reporter insisted that HAVRIX was not co-suspect although it was given in the same leg. The reporter strongly felt there was a quality issue with INFANRIX. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with INFANRIX. Follow-up information was received on 09 May 2008 via a healthcare professional, who reported that the subject's mother had to wrap a warm rag around the child's leg in order for the swelling to go down. The reporting healthcare professional considered the events to be clinically significant requiring intervention.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Pharmaceutical product complaint
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling of legs in a 4-year-old female subject who was vaccinated with INFANRIX(GlaxoSmithKline). Previous and/or concurrent vaccination included INFANRIX; GlaxoSmithKline; intramuscular given on an unspecified date; HAVRIX; GlaxoSmithKline; intramuscular, left thigh given on 26 April 2008; Ipol; Aventis Pasteur; unknown given on 26 April 2008; MMR II; Merck; unknown given on 26 April 2008; MMR II; Merck; unknown given on 26 April 2008. On 26 April 2008 the subject received 5th dose of INFANRIX (.5 ml, intramuscular, left thigh). On 28 April 2008, two days after vaccination with INFANRIX, the subject experienced swelling of legs, nodule at injection site, redness, painful to walk and pharmaceutical product complaint. The reporter insisted that HAVRIX was not co-suspect although it was given in the same leg. The reporter strongly felt there was a quality issue with INFANRIX. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with INFANRIX. Follow-up information was received on 09 May 2008 via a healthcare professional, who reported that the subject's mother had to wrap a warm rag around the child's leg in order for the swelling to go down. The reporting healthcare professional considered the events to be clinically significant requiring intervention.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Gait disturbance, Injection site nodule, Oedema peripheral, Pain
Clinical narrative: This case was reported by a health care professional and described the occurrence of swelling of legs in a 6-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). Previous and/or concurrent vaccination included INFANRIX; GlaxoSmithKline; intramuscular; unknown given on an unspecified date. On 26 April 2008, the subject received 5th dose of INFANRIX (.5 ml, intramuscular, left thigh). On 28 April 2008, two days after vaccination with INFANRIX, the subject experienced swelling of legs, nodule at injection site, redness, painful to walk and pharmaceutical product complaint. The reporter strongly felt there was a quality issue with INFANRIX. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with INFANRIX. Follow-up information was received on 09 May 2008 via a healthcare professional, who reported that the subject's mother stated that the child's leg was very swollen, not just "knotty". The reporting healthcare professional considered the events to be clinically significant requiring intervention.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Pharmaceutical product complaint
Clinical narrative: This case was reported by a health care professional and described the occurrence of swelling of legs in a 6-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). Previous and/or concurrent vaccination included INFANRIX; GlaxoSmithKline; intramuscular; unknown given on an unspecified date. On 26 April 2008, the subject received 5th dose of INFANRIX (.5 ml, intramuscular, left thigh). On 28 April 2008, two days after vaccination with INFANRIX, the subject experienced swelling of legs, nodule at injection site, redness, painful to walk and pharmaceutical product complaint. The reporter strongly felt there was a quality issue with INFANRIX. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with INFANRIX. Follow-up information was received on 09 May 2008 via a healthcare professional, who reported that the subject's mother stated that the child's leg was very swollen, not just "knotty". The reporting healthcare professional considered the events to be clinically significant requiring intervention.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Anion gap increased, Antibody test abnormal, Bacteria urine no organism observed, Band neutrophil count increased, Basophil percentage
Clinical narrative: Shots given in office about 9AM.  Pt. with seizures - generalized jerking movements about 2:10pm.  Tx O2 911 called pt. taken to ER.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Bilirubin urine, Blood calcium normal, Blood chloride normal, Blood creatinine decreased, Blood glucose increased
Clinical narrative: Shots given in office about 9AM.  Pt. with seizures - generalized jerking movements about 2:10pm.  Tx O2 911 called pt. taken to ER.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Blood osmolarity normal, Blood potassium normal, Blood sodium normal, Blood urea nitrogen/creatinine ratio increased, Blood urea normal
Clinical narrative: Shots given in office about 9AM.  Pt. with seizures - generalized jerking movements about 2:10pm.  Tx O2 911 called pt. taken to ER.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Blood urine present, Carbon dioxide abnormal, Chromaturia, Convulsion, Differential white blood cell count
Clinical narrative: Shots given in office about 9AM.  Pt. with seizures - generalized jerking movements about 2:10pm.  Tx O2 911 called pt. taken to ER.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Dyskinesia, Eosinophil count, Full blood count, Glucose urine present, Granulocyte count decreased
Clinical narrative: Shots given in office about 9AM.  Pt. with seizures - generalized jerking movements about 2:10pm.  Tx O2 911 called pt. taken to ER.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Haematocrit normal, Haemoglobin normal, Lymphocyte count normal, Lymphocyte morphology normal, Lymphocyte percentage
Clinical narrative: Shots given in office about 9AM.  Pt. with seizures - generalized jerking movements about 2:10pm.  Tx O2 911 called pt. taken to ER.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume abnormal, Mean platelet volume normal, Monocyte count normal
Clinical narrative: Shots given in office about 9AM.  Pt. with seizures - generalized jerking movements about 2:10pm.  Tx O2 911 called pt. taken to ER.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Monocyte percentage, Neutrophil count, Nitrite urine absent, Platelet count normal, Platelet morphology normal
Clinical narrative: Shots given in office about 9AM.  Pt. with seizures - generalized jerking movements about 2:10pm.  Tx O2 911 called pt. taken to ER.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Protein urine absent, Red blood cell count normal, Red blood cell morphology normal, Red blood cells urine negative, Red cell distribution width decreased
Clinical narrative: Shots given in office about 9AM.  Pt. with seizures - generalized jerking movements about 2:10pm.  Tx O2 911 called pt. taken to ER.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Specific gravity urine normal, Urine abnormality, Urine analysis, Urine ketone body absent, Urine leukocyte esterase
Clinical narrative: Shots given in office about 9AM.  Pt. with seizures - generalized jerking movements about 2:10pm.  Tx O2 911 called pt. taken to ER.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Urobilin urine present, White blood cell count normal, White blood cells urine negative, pH urine normal
Clinical narrative: Shots given in office about 9AM.  Pt. with seizures - generalized jerking movements about 2:10pm.  Tx O2 911 called pt. taken to ER.
Age: 51.0
Sex: M
Vaccine: FLU3, HEP, TDAP, TYP
Symptoms: Blood pressure, Electrocardiogram normal, Loss of consciousness
Clinical narrative: After leaving clinic patient passed out at desk while at work; was taken to ER and released.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: 24-48 hours of vaccination child had diarrhea and fever with vomiting starting in the evening after shots.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Culture, Erythema, Pruritus
Clinical narrative: Sat 5-10-08 red with cluster of blisters, itches & burns always.  Thur-started getting worse called Dr made appt for 5-16-08.  Tx generic for ZOVARAX & generic for VICODIN VZV culture done.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pain, Pain in extremity
Clinical narrative: Injection site left arm with erythema and swelling 5 x 7.5cm.  Induration same (5 x 7.5cm).  Pain radiates to left thumb.  Pain 6/10 - throbbing.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Rash, Urticaria
Clinical narrative: Pain at injection site, swelling with hive like rash 6days after shot.
Age: 17.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Blood pressure, Dizziness, Heart rate
Clinical narrative: Patient became lightheaded.  Patient laid on table and no LOC.  Given ginger ale & lollipops.  BP 130/80 after vaccine & HR 70.  AAO x3.  Pt observed x15-20 mins alert full recovery and discharged to home.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Granulocyte count increased, Skin warm, White blood cell count increased
Clinical narrative: Mom called and talked with triage nurse on 5-15-08.  Patient had golf ball size area of redness, warmth to touch.  No drainage, fevers at this time so decided to watch one more day as this can happen with vaccines.  Mom encouraged to call though if any changes.  Mom called back on AM of 5-16-08 because spot had increased to grapefruit size and remained warm/hot to touch.  Patient seen twice 5/16/08 due to mom wanting 2nd opinion.
Age: 1.61
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: BOOSTRIX, instead of INFANRIX, was administered the doses of the Tetanus, Diphtheria and Pertussis are less then the INFANRIX.
Age: 3.0
Sex: F
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: BOOSTRIX, instead of INFANRIX was administered.  The doses of the Tetanus, Diptheria, Pertussis are less than the INFANRIX.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Erythema infectiosum, Oedema peripheral, Pruritus, Pyrexia
Clinical narrative: Child's mother, reports a rash that started with a low grade fever (100.4) on 5-16-08. The rash worsened on 5-17-08. It covered her chest, back, trunk and face. Her cheeks were very red with white, raised areas noted. The rash on chest and trunk and back was red and "splotchy," not raised. Her right arm, where she received the DTaP and VAR, was swollen and very red; also itched. She saw her doctor on 5-16-08 for another health issue; the Dr told mom to "watch the rash." I talked to mom on 5/19/08 - she says the rash is getting better; no fever. follow up 1/15/10 - 6/2/08 update - after i reported this, the child's rash worsened.  parent took the child to the dr - she was diagnosed with Fifth's Disease.  the dr felt the  rash was due to illiness, not vaccine.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash, Rash macular
Clinical narrative: Child's mother, reports a rash that started with a low grade fever (100.4) on 5-16-08. The rash worsened on 5-17-08. It covered her chest, back, trunk and face. Her cheeks were very red with white, raised areas noted. The rash on chest and trunk and back was red and "splotchy," not raised. Her right arm, where she received the DTaP and VAR, was swollen and very red; also itched. She saw her doctor on 5-16-08 for another health issue; the Dr told mom to "watch the rash." I talked to mom on 5/19/08 - she says the rash is getting better; no fever. follow up 1/15/10 - 6/2/08 update - after i reported this, the child's rash worsened.  parent took the child to the dr - she was diagnosed with Fifth's Disease.  the dr felt the  rash was due to illiness, not vaccine.
Age: 22.0
Sex: F
Vaccine: TD
Symptoms: Dizziness, Nausea, Syncope
Clinical narrative: Patient immediately began feeling lightheaded and nauseated.  Then patient became dizzy and fainted.  Patient was revived.  Upon awakening, patient remained dizzy and had trouble talking.  BENADRYL was administered.  Patient slept off the symptoms and was fine next day.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Photophobia, Rash
Clinical narrative: 5/19/08 awoke this AM with a rash primarily on face to a lesser extent on arms/torso.  History Rosacea with 10 min sun exposure past 2y.  Also, photophobia, conj. inj. dizziness - type 2 diabetes.
Age: 31.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site induration, Pain in extremity
Clinical narrative: Donor received shot on 5-14-08 and adverse reaction noted. On 5-16-08 Donor states arm was sore after doing alot of heavy lifting light yard work. On 5-18-08 donor phoned center to report to medical staff, MSA asked donor to comes to center. Donor presents at center with 6"x4" red area with 2x2" hard area at injection site.
Age: 1.02
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Unevaluable event
Clinical narrative: VARIVAX given 12-19-03; No known history wild type Varicella disease; sign of shingles about 2 weeks prior to today's exam (was out of town and I did not see active lesions although Dx is clear)
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Injection site rash, Injection site urticaria, Pain in extremity
Clinical narrative: Mother reports to ER 5/17/08 in afternoon as had rash/hives on right thigh where vaccines were given, patient verbalized right leg hurt. Did receive BENADRYL, instructed to use warm compresses. Rash has decreased. Today - 5/19/08 at 1315 - area approximate 7 inch diameter is reddened, no induration noted. No pain with palpation noted.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein amniotic fluid normal, Complication of delivery, Drug exposure during pregnancy, Ultrasound scan normal
Clinical narrative: Initial and follow-up information has been received from a physician concerning a female with a history of obesity and no concurrent medical conditions, who on 22-MAR-2007 was vaccinated IM with a first dose of GARDASIL (Lot# 657006/0188U).  Subsequently, the patient was pregnant.  The physician reported that the patient was in her first trimester.  The patient's last menstrual period was 16-FEB-2007 and her estimated delivery date was 23-NOV-20067 (also reported as 18-DEC-2007).  On 10-JUL-2007 a Maternal Serum Alpha-Fetoprotein Screening (MSAFP) was performed and was low risk.  On 17-JUL-2007 an ultrasound was performed and showed normal anatomy.  The patient took prenatal vitamins throughout the duration of her pregnancy, calcium during the 2nd and 3rd trimester, and iron during the last month of her pregnancy.  It was reported that the patient had one previous pregnancy and one spontaneous abortion at 5 weeks.  No further information was available.  Follow-up information indicated that 43 weeks from her last menstrual period (also reported as 38 weeks) on 15-DEC-2007 the patient delivered a female infant that weighed 7 pounds 4 ounces, and had an Apgar score of 8/9.  It was reported there was a complication of fetal intolerance to labor during the delivery.  The patient received routine prenatal testing during her pregnancy.  It was reported that the infant was normal with no congenital anomalies, complications, or abnormalities.  Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Haemorrhage, Herpes simplex
Clinical narrative: Initial and follow up information has been received for the pregnancy registry for GARDASIL from a registered nurse concerning a 26 year old female with allergies, bipolar, depression, Von Willebrand disease type 1 due to aspirin intake, genital herpes, irritable bowel syndrome, migraine headaches, panic attacks and allergies to Pseudophedrine, Ibuprofen and Aspirin who on 15-MAY-2007 was vaccinated IM with 0.5 mL GARDASIL (lot # 655205/1426F).  Concomitant therapy included ZYRTEC and EFFEXOR.  On 29-MAY-2007 the patient had a positive pregnancy test (LMP 21-APR-2007, EDD 26-Jan-2008) and therapy with venlafaxine HCL was discontinued.  On 02-AUG-2007 an ultrasound revealed a subchorionic hemorrhage which resolved without intervention on unspecified date.  A maternal serum alpha fetoprotein test on 15-AUG-2007 was normal.  On 11-OCT-2007 the patient was diagnosed with a urinary tract infection and treated with Ceftin, 250 mg, PO, BID.  On 03-JAN-2008 the patient began treatment with Acyclovir, 400 mg, BID for herpes simplex virus.  On 05-JAN-2008 at 37 weeks the patient had a spontaneous rupture of membranes and gave birth to a normal male infant who weighed 7 lbs. 5 oz.  His apgar scores were 9/9.  The patient completed therapy with Acyclovir on 15-JAN-2008.  Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan abnormal, Urinary tract infection
Clinical narrative: Initial and follow up information has been received for the pregnancy registry for GARDASIL from a registered nurse concerning a 26 year old female with allergies, bipolar, depression, Von Willebrand disease type 1 due to aspirin intake, genital herpes, irritable bowel syndrome, migraine headaches, panic attacks and allergies to Pseudophedrine, Ibuprofen and Aspirin who on 15-MAY-2007 was vaccinated IM with 0.5 mL GARDASIL (lot # 655205/1426F).  Concomitant therapy included ZYRTEC and EFFEXOR.  On 29-MAY-2007 the patient had a positive pregnancy test (LMP 21-APR-2007, EDD 26-Jan-2008) and therapy with venlafaxine HCL was discontinued.  On 02-AUG-2007 an ultrasound revealed a subchorionic hemorrhage which resolved without intervention on unspecified date.  A maternal serum alpha fetoprotein test on 15-AUG-2007 was normal.  On 11-OCT-2007 the patient was diagnosed with a urinary tract infection and treated with Ceftin, 250 mg, PO, BID.  On 03-JAN-2008 the patient began treatment with Acyclovir, 400 mg, BID for herpes simplex virus.  On 05-JAN-2008 at 37 weeks the patient had a spontaneous rupture of membranes and gave birth to a normal male infant who weighed 7 lbs. 5 oz.  His apgar scores were 9/9.  The patient completed therapy with Acyclovir on 15-JAN-2008.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Foetal activity test, Streptococcal identification test positive, Ultrasound scan
Clinical narrative: Initial and follow up information has been received from a healthcare professional and a physician, via the Merck pregnancy registry, concerning a 20 year old female patient with no previous pregnancies, with gastrooesophageal reflux disease and papilloma viral infection and a history of anaemia, pneumonia, infectious mononucleosis, ulcer, Papanicolaou smear abnormal and colposcopy, who in May 2007, was vaccinated with the first dose of GARDASIL.  The date of the LMP was approximately 01-May-2007, date of conception estimated as 15-MAY-2007.  On 25-JUN-2007, an ultrasound confirmed the patient to be 8 weeks and 1 day into the pregnancy; the estimated date of delivery was 05-FEB-2008.  Follow-up information was received from the physician's office.  On 06-FEB-2008 the patient delivered a healthy 7 pound 2 ounces baby boy with an Apgar score of 8/9.  The patient was 40 weeks from LMP.  The patient was Group B streptococcus positive (GBS+).  From 19-DEC-2007 to 22-JAN-2008 fetal activity both reactive was monitored for decreased fetal motion.  Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Alpha 1 foetoprotein amniotic fluid normal, Drug exposure during pregnancy, Premature labour, Ultrasound scan abnormal, Umbilical cord abnormality
Clinical narrative: Information has been received from a licensed practical nurse through the Pregnancy Registry for GARDASIL concerning a 16 year old, female smoker, with no previous pregnancies, who on 20-FEB-2007 was vaccinated intramuscularly with the first dose of GARDASIL (Lot # 654389/0961F).  On 23-APR-2007, the patient was vaccinated intramuscularly with her second dose of GARDASIL (Lot # 655205/1426F).  On 22-AUG-2007, the patient was vaccinated intramuscularly with her third dose of GARDASIL (Lot # 655620/0171U) and in addition was vaccinated with a VAQTA vaccine (MSD; not lot # reported).  On 24-AUG-2007 the patient was seen at the doctor's office for a urine pregnancy test which was positive (LMP 13-JUN-2007).  On 12-SEP-2007, the patient had an ultrasound for the purpose of dating which was normal and indicated that the fetus was 12 weeks and 4 days gestation.  From November 2007 to January 2008, the patient was taking vitamins with iron daily.  On 07-NOV-2007, the patient had an ultrasound for Level II screening which had the fetus at 20 weeks and 1 day gestation and showed an eccentric cord insertion (not further specified).  The patient also has an MSAFP for screening purposes and the results were within normal limits.  On 31-Jan-2008, the patient gave birth to a live 3 lb, 12 oz female infant (32 weeks and 6 days from LMP).  It was also reported that the patient had preterm delivery at 32 weeks and 4 days.  The baby had Apgar scores of 7 and 8, and there were no congenital anomalies.  No additional information is expected.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a licensed practical nurse through the Pregnancy Registry for GARDASIL concerning a 16 year old, female smoker, with no previous pregnancies, who on 20-FEB-2007 was vaccinated intramuscularly with the first dose of GARDASIL (Lot # 654389/0961F).  On 23-APR-2007, the patient was vaccinated intramuscularly with her second dose of GARDASIL (Lot # 655205/1426F).  On 22-AUG-2007, the patient was vaccinated intramuscularly with her third dose of GARDASIL (Lot # 655620/0171U) and in addition was vaccinated with a VAQTA vaccine (MSD; not lot # reported).  On 24-AUG-2007 the patient was seen at the doctor's office for a urine pregnancy test which was positive (LMP 13-JUN-2007).  On 12-SEP-2007, the patient had an ultrasound for the purpose of dating which was normal and indicated that the fetus was 12 weeks and 4 days gestation.  From November 2007 to January 2008, the patient was taking vitamins with iron daily.  On 07-NOV-2007, the patient had an ultrasound for Level II screening which had the fetus at 20 weeks and 1 day gestation and showed an eccentric cord insertion (not further specified).  The patient also has an MSAFP for screening purposes and the results were within normal limits.  On 31-Jan-2008, the patient gave birth to a live 3 lb, 12 oz female infant (32 weeks and 6 days from LMP).  It was also reported that the patient had preterm delivery at 32 weeks and 4 days.  The baby had Apgar scores of 7 and 8, and there were no congenital anomalies.  No additional information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Delivery, Drug exposure during pregnancy, No adverse event
Clinical narrative: Information has been received from a nurse through the Merck pregnancy registry concerning an 18 year old female with attention deficit/hyperactivity disorder and allergies to codeine and ULTRAM who 26-JAN-2007 was vaccinated intramuscularly with her first dose of GARDASIL (Lot 3 654741/0013U). On 02-APR-2007, the patient was vaccinated intramuscularly with her second dose of GARDASIL vaccines (Lot # 657617/0384U). On 03-JUL-2007, the patient was vaccinated intramuscularly with her third dose of GARDASIL (Lot # 658100/0525U). On 18-SEP-2007, it was reported that the patient was at 13 weeks gestation (LMP=19-JUN-2007). There was no adverse experienced related to this event. The nurse reported information based on information provided by the patient's grandmother during a telephone conversation. "The baby was born in March 2008 and is doing fine. Only has a little bit of gas/GI Issues but is fine. As far as they know the baby is healthy and normal with no congenital anomalies." No additional information is expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein amniotic fluid normal, Cholestasis of pregnancy, Drug exposure during pregnancy, Ultrasound scan normal
Clinical narrative: Information has been received from a nurse through the Pregnancy Registry for GARDASIL concerning a 16 year old female, with a history of obesity (BMI 35), and no previous pregnancies, who on 29-MAR-2007 received her first vaccination with GARDASIL (Lot # 654702/0011U). On 31-MAY-2007, the patient received her second vaccination with GARDASIL (Lot # 654702/0011U). Subsequently, the patient became pregnant (LMP = 28-JUN-2007). On 18-SEP-2007, the patient had an ultrasound for dating purposes which was normal indicated a single IUP at 10 weeks. On 02-OCT-2007 and 01-NOV-2007, the patient had integrated screening for maternal serum alpha-fetoprotein which were negative. On an unspecified date, the patient developed cholestasis of pregnancy and was treated with URSO FORTE, outcome was not reported. It was reported that at 16 weeks (approximately 30-OCT-2007) through approximately 19 weeks (approximately 20-Nov-2007), the patient was treated with REGLAN. Other medications used during pregnancy included prenatal vitamins (not specified) and permethrin cream (not further specified). Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Appendicectomy, Appendicitis, Diagnostic procedure, Drug exposure during pregnancy
Clinical narrative: Initial and follow-up information has been received through the Merck pregnancy registry through a 25 year old female who on 21-SEP-2007 was vaccinated with intramuscularly with her first dose of GARDASIL. On 25-OCT-2007, the patient was vaccinated intramuscularly with her second dose of GARDASIL. There was no concomitant medication. The patient reported that after receiving her second vaccination on 25-OCT-2007 she discovered she was "4 weeks pregnant" (LMP approximately 27-SEP-2007). It was reported by the patient that "everything was fine" and she was probably going to have a cesarean section in June. On 21-APR-2008 the patient had an appointment and "everything looked great." The baby's weight was "fine" and her fungal height was normal. "A few weeks ago" the patient experienced appendicitis and was hospitalized in order to have her appendix removed. The patient did not think the appendicitis was related to the vaccine. The patient recovered and it was reported that the patient and the baby were doing fine. No further information was provided. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Ultrasound scan, Venous lake
Clinical narrative: Information has been received through the Pregnancy Registry for GARDASIL through a nurse practitioner concerning a 15 year old white, non-smoker female, with acne and no previous pregnancies, who on 02-AUG-2007 was vaccinated intramuscularly with her first dose of GARDASIL (Lot #657006/0188U).  Concomitant therapy included ORTHO EVRA and "minocycline".  Subsequently, the patient found out she was pregnant (LMP = 22-JUN-2007).  The patient had an ultrasound (not further specified).  The patient sought unspecified medical attention.  Follow-up information received 10-APR-2008 from the physician reported that on 01-NOV-2007, the patient had an ultrasound which was normal except "small venous lakes in the placenta".  The reporter also indicated that the patient had stopped therapy with ORTHO EVRA (date not specified).  From November 2007 until present, the patient has been on prenatal vitamins (not further specified).  The patient discontinued treatment with minocycline for acne in November 2007.  On 04-Jan-2008, the patient was given a flu shot (not further specified).  There were no complications during pregnancy.  On 02-Mar-2008, the patient delivered a female infant, 5 pounds, 7 ounces, 18 1/4 inches long, and an apgar score of 8/9.  Delivery was 36 weeks and 2 days from LMP.  The infant had no congenital anomalies, no complications or abnormalities, and there were no complications during labor and delivery.  No additional information is expected.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Drug exposure during pregnancy, Foetal disorder, Pregnancy test positive
Clinical narrative: Information has been received from a certified medical assistant, for the Pregnancy Registry for GARDASIL, concerning a 17 year old female who on 30-OCT-2007 (also reported as 18-JUL-2007) was vaccinated intramuscularly with the first dose of GARDASIL (655165/1425F). Per the reporter, the patient was pregnant at the time of vaccination (Gestation = 36 weeks; LMP approximately 04-Mar-2007). The pregnancy was confirmed by a pregnancy test. Concomitant therapy included vaccination with the first dose of VAQTA (653616/0511F) on 18-SEP-2006 and the second dose of VAQTA (654514/0304U) on 30-OCT-2007 (dose, duration not reported). The patient is not experiencing any known symptoms. No further information is available. It was reported that on 02-DEC-2007 the patient delivered a baby girl via vaginal delivery that is normal, no congenital anomalies. "but has had some illnesses". Birth weight was 6lbs 10oz, Apgar scores were 9 and 9. The baby did have a right parietal cephalohematoma at birth due to probable vacuum use during delivery. The baby also experienced some illnesses, most respiratory issues including RSV pneumonitis which has resolved. The reporter indicated that the patient has a high level of exposure to school aged children family members. There was also some jaundice at birth which has also resolved. The baby has also had some thrush. On 04-APR-2008 it was indicated by the physician that the baby was a "healthy baby girl with some eczema. No additional information is expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Nausea, Ultrasound abdomen, Vomiting
Clinical narrative: Information and follow up has been received from a physician for the Pregnancy Registry for GARDASIL concerning a 25 year old female with a history of 1 pregnancy and 1 live birth who was vaccinated on 12-OCT-2007 with her first dose of GARDASIL (lot# 0530U). On 07-DEC-2007 the patient was vaccinated with her second dose of GARDASIL (lot# 655322/1211U) and became pregnant. Concomitant therapy included prenatal vitamins (unspecified). The patient's LMP was reported as 01-JAN-2008 with an estimated due date of 10-OCT-2008. The patient had an ultrasound on 01-JAN-2008 and the results of the test were IUG-6W4D. On 17-MAR-2008 the patient developed nausea and vomiting which were treated with PHENERGAN. At the time of this report it was unknown if the patient had recovered from nausea and vomiting. No further information was available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: Information has been received from a health professional concerning a 24 year old female who on 11-MAR-2008 was vaccinated SQ with the third dose of GARDASIL (659182/1757U). On 11-MAR-2008 the patient experienced injection site soreness and incorrect route of administration. Subsequently, the patient recovered from the injection site soreness and incorrect route of administration. Per the reporter, there were no reactions with the first two doses. Additional information has been requested. 07/08/08 This is in follow-up to report(s) previously submitted on 4/14/2008. Information has been received from a health professional concerning a 24 year old (previously reported as 31 year old) female who on 12-SEP-2007 was vaccinated with the first dose of GARDASIL. On 12-Nov-2007, the patient received the second dose and on 11-Mar-2008 received the third dose SQ (lot# 659182/1757U). After the third dose the patient experienced increased soreness at the injection site and not experienced with the prior doses. The patient was seen in the doctor's office. The patient was recovered.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Information has been received concerning a 19 year old female with a history of allergic reaction to antibiotics who on 14-NOV-2007 was vaccinated IM in the deltoid with the first dose of GARDASIL (658560/1062U). Concomitant therapy included LOESTRIN. On 15-NOV-2007 the patient experienced nausea, vomiting, fever, chills and headache. Additional information received from NSC call (14-APR-2008): The caller states that she continues to receive letters from WPS about WAES 0804USA00354. The caller does not know who the WPS letter was addressed to. The caller was unable to locate the SR associated with this WAES #. The caller states that she has returned a previous letter from WPS and does not want to receive any more letters. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised, Urticaria
Clinical narrative: Information has been received from a physician concerning a 19 year old female with penicillin allergy who on 18-OCT-2007 was vaccinated intramuscularly in the left deltoid with a first dose of GARDASIL (Lot # 658488/1264U). There was no concomitant medication. On 18-OCT-2007, within hours of vaccination, the patient developed hives all over her body. Subsequently, several days later, the patient recovered from hives all over her body without any treatment. Additional information has been requested.