chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: CSF protein increased, Demyelinating polyneuropathy, Electromyogram abnormal, Fatigue, Gait disturbance
Clinical narrative: Guillian-Barre Syndrome with loss of sensation in hands/feet and proximal muscle weakness onset on 12/08/08. No improvement as of yet 4 days of IVIG beginning 1/15/09 (Hospitalized).  5/8/09 Received Neuro medical records of 1/12-4/20/2009 which included hospital d/c summary & H&P of 2/16-2/28/09 admit. FINAL DX: acute inflammatory demyelinating polyneuropathy Records reveal patient seen for eval on 1/12/09.  Exam revealed decreased sensation in hands/feet, decreased reflexes.  Seen by second Neuro on 1/15 & 1/28/09 for eval & repeat EMG/NCS which remained abnormal & c/w acute/subacute sensory-motor demyelinating peripheral neuropathy w/significant radicular component.  RTC 3/17/09 improved, started on steroid taper & referred for PT/OT.  RTC 4/15/09 & continued to slowly improve w/excessive tiredness, fatigue, paresthesias of hands/feet & difficulty walking uphill.  Continued PT/OT.  3/18/09 Received hospital medical records of 1/15-1/18/2009. FINAL DX: atypical Guillain-Barre syndrome  Records reveal patient experienced progressive numbness, tingling, pain & weakness of extremities esp hands/feet, difficulty walking, grip strength & dexterity were decreased starting 2 weeks s/p flu shot.  LP done.  Reflexes present but decreased.  Tx w/IVIG & made slight improvement.  Sent to inpatient rehab.  Patient was readmitted for relapse from 2/16/09-2/28/09 FINAL DX: acute GBS s/p vaccination   Patient developed increased difficulty walking, increased muscle weakness, SOB, loss of balance.  Had repeat EMG/NCS done as outpatient which were c/w sensory motor, peripheral neuropathy w/demyelinating features.  Exam revealed near normal muscle strength but DTRs were diminished throughout, sensation was slightly decreased & gait was quite abnormal.  Tx w/plasmapheresis x 7 & steroids. Follow-up: Residual generalized weakness (muscle strength), fatigue, neuropathic pain, and continued paresthesia/numbness feet.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Muscular weakness, Nerve conduction studies abnormal
Clinical narrative: Guillian-Barre Syndrome with loss of sensation in hands/feet and proximal muscle weakness onset on 12/08/08. No improvement as of yet 4 days of IVIG beginning 1/15/09 (Hospitalized).  5/8/09 Received Neuro medical records of 1/12-4/20/2009 which included hospital d/c summary & H&P of 2/16-2/28/09 admit. FINAL DX: acute inflammatory demyelinating polyneuropathy Records reveal patient seen for eval on 1/12/09.  Exam revealed decreased sensation in hands/feet, decreased reflexes.  Seen by second Neuro on 1/15 & 1/28/09 for eval & repeat EMG/NCS which remained abnormal & c/w acute/subacute sensory-motor demyelinating peripheral neuropathy w/significant radicular component.  RTC 3/17/09 improved, started on steroid taper & referred for PT/OT.  RTC 4/15/09 & continued to slowly improve w/excessive tiredness, fatigue, paresthesias of hands/feet & difficulty walking uphill.  Continued PT/OT.  3/18/09 Received hospital medical records of 1/15-1/18/2009. FINAL DX: atypical Guillain-Barre syndrome  Records reveal patient experienced progressive numbness, tingling, pain & weakness of extremities esp hands/feet, difficulty walking, grip strength & dexterity were decreased starting 2 weeks s/p flu shot.  LP done.  Reflexes present but decreased.  Tx w/IVIG & made slight improvement.  Sent to inpatient rehab.  Patient was readmitted for relapse from 2/16/09-2/28/09 FINAL DX: acute GBS s/p vaccination   Patient developed increased difficulty walking, increased muscle weakness, SOB, loss of balance.  Had repeat EMG/NCS done as outpatient which were c/w sensory motor, peripheral neuropathy w/demyelinating features.  Exam revealed near normal muscle strength but DTRs were diminished throughout, sensation was slightly decreased & gait was quite abnormal.  Tx w/plasmapheresis x 7 & steroids. Follow-up: Residual generalized weakness (muscle strength), fatigue, neuropathic pain, and continued paresthesia/numbness feet.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Neuralgia, Pain in extremity, Paraesthesia, Peripheral sensorimotor neuropathy, Sensory loss
Clinical narrative: Guillian-Barre Syndrome with loss of sensation in hands/feet and proximal muscle weakness onset on 12/08/08. No improvement as of yet 4 days of IVIG beginning 1/15/09 (Hospitalized).  5/8/09 Received Neuro medical records of 1/12-4/20/2009 which included hospital d/c summary & H&P of 2/16-2/28/09 admit. FINAL DX: acute inflammatory demyelinating polyneuropathy Records reveal patient seen for eval on 1/12/09.  Exam revealed decreased sensation in hands/feet, decreased reflexes.  Seen by second Neuro on 1/15 & 1/28/09 for eval & repeat EMG/NCS which remained abnormal & c/w acute/subacute sensory-motor demyelinating peripheral neuropathy w/significant radicular component.  RTC 3/17/09 improved, started on steroid taper & referred for PT/OT.  RTC 4/15/09 & continued to slowly improve w/excessive tiredness, fatigue, paresthesias of hands/feet & difficulty walking uphill.  Continued PT/OT.  3/18/09 Received hospital medical records of 1/15-1/18/2009. FINAL DX: atypical Guillain-Barre syndrome  Records reveal patient experienced progressive numbness, tingling, pain & weakness of extremities esp hands/feet, difficulty walking, grip strength & dexterity were decreased starting 2 weeks s/p flu shot.  LP done.  Reflexes present but decreased.  Tx w/IVIG & made slight improvement.  Sent to inpatient rehab.  Patient was readmitted for relapse from 2/16/09-2/28/09 FINAL DX: acute GBS s/p vaccination   Patient developed increased difficulty walking, increased muscle weakness, SOB, loss of balance.  Had repeat EMG/NCS done as outpatient which were c/w sensory motor, peripheral neuropathy w/demyelinating features.  Exam revealed near normal muscle strength but DTRs were diminished throughout, sensation was slightly decreased & gait was quite abnormal.  Tx w/plasmapheresis x 7 & steroids. Follow-up: Residual generalized weakness (muscle strength), fatigue, neuropathic pain, and continued paresthesia/numbness feet.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV1
Symptoms: Blood calcium normal, Blood chloride increased, Blood glucose normal, Blood potassium increased, Full blood count normal
Clinical narrative: Vaccines administered 2/05/09 in morning. Parents report mom picked up child from crib for 9 p.m feeding. Child was unresponsive and limp. Father began CPR. Child responded. Ambulance arrived but did not transport child to hospital. I was notified of episode one week later. Child was electively admitted to hospital.  3/18/09 MR received for DOS 2/12-14/2009 with DX:  ALTE.  Pt presented 3 days s/p an episode of limpness.  Parent usure if child was breathing.  Parent began CPR and continued while pt was crying.  Upon EMS arrive pt behaving normally.  Episode reported to PCP  who recommended inpt eval which was (-). No apnea or brady. D/C on home apnea monitoring.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV1
Symptoms: Hypotonia, Liver function test normal, Resuscitation, Unresponsive to stimuli
Clinical narrative: Vaccines administered 2/05/09 in morning. Parents report mom picked up child from crib for 9 p.m feeding. Child was unresponsive and limp. Father began CPR. Child responded. Ambulance arrived but did not transport child to hospital. I was notified of episode one week later. Child was electively admitted to hospital.  3/18/09 MR received for DOS 2/12-14/2009 with DX:  ALTE.  Pt presented 3 days s/p an episode of limpness.  Parent usure if child was breathing.  Parent began CPR and continued while pt was crying.  Upon EMS arrive pt behaving normally.  Episode reported to PCP  who recommended inpt eval which was (-). No apnea or brady. D/C on home apnea monitoring.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Diarrhoea, Nausea, Pneumonia
Clinical narrative: Approximately 4 days after immunization, pt had nausea that went to fever, chills and extreme diarrhea - went to urgent care about 1 1/2 weeks also had dry cough - treated for pneumonia, gave antibiotic abt 3-4 days. Went to Primary care with all the symptoms - placed on BRAT diet for 2-3 days and went to ER. Admitted - rehydrated and found spot? on lung - diarrhea and other symptoms subsided after 2 days in hospital but they kept her to work up lung condition. Possible valley fever.   3/23/09 MR received for DOS 11/21-12/04/2008 with D/C DX:  Interstitial Lung Disease, newly diagnosed.  Pathology c/w but not confirmatory for UIP (Usual Interstitial Pneumonia).  Hypoxemia 2' to interstitial lung disease.  False (+) coccidiomycosis IgM titre.  HTN.  Hyperlipidemia.  Pleauritic Chest Pain.  SOB and cough.  Antibiotic induced diarrhea.  Gastroenteritis.   Pt presented with several week hx of weakness, fatigue, nausea, vomiting, diarrhea and SOB with cough since receiving Flu shot 11/3/08. Recent worsening of SOB with ambulation precipitated ER visit. Initially dx with PNA at urgent care and placed on abx.  No improvement x1 wk on abx. Admitted for complete w/u. PE (+) for rhonchi and rales. Abx changed. Pt continued to desat w/ ambulation. ? Coccidiomycosis so antifungal added with no response. Thoracoscopy done for bx with chest tube placed. When removed, d/c for outpt f/u with O2 supplementation PRN.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Approximately 4 days after immunization, pt had nausea that went to fever, chills and extreme diarrhea - went to urgent care about 1 1/2 weeks also had dry cough - treated for pneumonia, gave antibiotic abt 3-4 days. Went to Primary care with all the symptoms - placed on BRAT diet for 2-3 days and went to ER. Admitted - rehydrated and found spot? on lung - diarrhea and other symptoms subsided after 2 days in hospital but they kept her to work up lung condition. Possible valley fever.   3/23/09 MR received for DOS 11/21-12/04/2008 with D/C DX:  Interstitial Lung Disease, newly diagnosed.  Pathology c/w but not confirmatory for UIP (Usual Interstitial Pneumonia).  Hypoxemia 2' to interstitial lung disease.  False (+) coccidiomycosis IgM titre.  HTN.  Hyperlipidemia.  Pleauritic Chest Pain.  SOB and cough.  Antibiotic induced diarrhea.  Gastroenteritis.   Pt presented with several week hx of weakness, fatigue, nausea, vomiting, diarrhea and SOB with cough since receiving Flu shot 11/3/08. Recent worsening of SOB with ambulation precipitated ER visit. Initially dx with PNA at urgent care and placed on abx.  No improvement x1 wk on abx. Admitted for complete w/u. PE (+) for rhonchi and rales. Abx changed. Pt continued to desat w/ ambulation. ? Coccidiomycosis so antifungal added with no response. Thoracoscopy done for bx with chest tube placed. When removed, d/c for outpt f/u with O2 supplementation PRN.
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Dysarthria, Dyspnoea, Hypoaesthesia, Influenza like illness, Injection site warmth
Clinical narrative: Student dropped off at Mall. At 5:30pm student called mother with Sx of SOB, grey lips, perspiration, pale skin color, numbness of legs, slurred speech. Injection site warm only. States Sx moved from head to toe. Mother took student to Urgent Care. Mother told to give BENADRYL and ibuprofen by Urgent Care MD. Student continues to have flu-like symptoms with fever on 2/27/09.
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Pallor, Pyrexia
Clinical narrative: Student dropped off at Mall. At 5:30pm student called mother with Sx of SOB, grey lips, perspiration, pale skin color, numbness of legs, slurred speech. Injection site warm only. States Sx moved from head to toe. Mother took student to Urgent Care. Mother told to give BENADRYL and ibuprofen by Urgent Care MD. Student continues to have flu-like symptoms with fever on 2/27/09.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt received ZOSTOVAX vaccine on 2/17/09 and three days later she developed shingles on right breast.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: Pt received IZ on 2/18/2009, mother phoned 2/19/2009 fever 104 advised ER.
Age: 1.07
Sex: M
Vaccine: FLU3, HEPA, PNC, VARCEL
Symptoms: Fall, Muscular weakness, Neurological examination normal, Pyrexia, Urticaria
Clinical narrative: See attached. Neurologist's assessment 2/20/09 - normal with coincidental viral infection with fever to 102 on day of visit 2/20/09.
Age: 1.07
Sex: M
Vaccine: FLU3, HEPA, PNC, VARCEL
Symptoms: Viral infection
Clinical narrative: See attached. Neurologist's assessment 2/20/09 - normal with coincidental viral infection with fever to 102 on day of visit 2/20/09.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Fainting after vaccines given.
Age: 14.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Eye swelling, Fatigue, Lacrimation increased, Nasal congestion, Postnasal drip
Clinical narrative: After 2 shots, pt complained of feeling "tired". This "feeling" lasted et mother reports had fever not measured via thermometer- 24 hours after injections, pt awoke with nasal congestion, swollen eyes et cough. Patient currently mouth breathing, sneezing with postnasal drip/eye tearing.
Age: 14.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Pyrexia, Sneezing
Clinical narrative: After 2 shots, pt complained of feeling "tired". This "feeling" lasted et mother reports had fever not measured via thermometer- 24 hours after injections, pt awoke with nasal congestion, swollen eyes et cough. Patient currently mouth breathing, sneezing with postnasal drip/eye tearing.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Oedema peripheral, Rash pruritic
Clinical narrative: Afternoon after am shot, mom called to report itchy rash on left arm with some swelling. Patient complained of knee and elbow pain.
Age: 41.0
Sex: F
Vaccine: FLUN3
Symptoms: Chest X-ray normal, Influenza like illness, Pyrexia, Wheezing
Clinical narrative: 3 days post immunization pt. c/o wheezing with exhalation.  The Monday following 11/10 she came down with flu-like symptoms + fever 101 degrees.  She saw her personal physician given Z Pack.  2 additional episodes in December + January treated with Z-Pack + OTC cold med CXR-negative in February.
Age: 14.0
Sex: F
Vaccine: MEN
Symptoms: Full blood count normal, Metabolic function test normal, Pain, Pyrexia, Vomiting
Clinical narrative: Onset of fever, generalized aching 24 hour after vaccine given.  Vomited 2 day after vaccine given.
Age: 28.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site streaking
Clinical narrative: PNEUMOVAX given IM Left deltoid on 2/18/09. On 2/19/09, pt returned to ofc with edema, pain and erythematous streaking from injection site down beneath axilla-streaking completely 1/2 way around his arm.
Age: 83.0
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash, Sleep disorder
Clinical narrative: Shingles broke out at 4:30 pm 11/08/08. Rash or blister like over left eye- on forehead + into scalp + hair. Not to painful but very uncomfortable especially at night. Have had many sleepless nights. Doctor prescribed some pills - for - 6 days at outset - then said its going to take its course.
Age: 49.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: Blister, Rash pruritic
Clinical narrative: Came in today stating that the day after getting her shots she developed Blisters in her scalp and itchy rash on her body. She did not seek medical attention and used Benadryl and Hydrocortisone. Rash left several days.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Urticaria
Clinical narrative: Hive like rash across abdomen with urticaria started 24 hour after Hepatitis B vaccine administration. Self treated with BENADRYL OTC and topical hydrocortisone cream otc. Rash resolving.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Pt got a large reddened area with raised rash at injection site. 11 days after injection.
Age: 12.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Cellulitis, Erythema, Induration, Swelling
Clinical narrative: R arm with severe redness/swelling & induration.  Worsened over several days pt treated with ABX for possible cellulitis & steroids/BENADRYL for allergic rxn.
Age: 1.3
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis
Clinical narrative: Left thigh cellulitis. Treated with Omnicef 120/5/ml 3.5 ml twice daily for 7 days.
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Antineutrophil cytoplasmic antibody, Blood immunoglobulin A, Complement factor, Epistaxis, Hypoaesthesia
Clinical narrative: Hemorrhagic purpura - developed 4-6 hrs after vaccine lasted 1 month - 2-3 developed nose bleed lasted 2 months swelling ankles lasted 2wks - wheezing developed 1-2 after vaccine - 3 weeks after vaccine when the swelling decreased had pain + numbness in left foot.
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Joint swelling, Pain in extremity, Purpura, Red blood cell sedimentation rate, Ultrasound Doppler
Clinical narrative: Hemorrhagic purpura - developed 4-6 hrs after vaccine lasted 1 month - 2-3 developed nose bleed lasted 2 months swelling ankles lasted 2wks - wheezing developed 1-2 after vaccine - 3 weeks after vaccine when the swelling decreased had pain + numbness in left foot.
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Wheezing
Clinical narrative: Hemorrhagic purpura - developed 4-6 hrs after vaccine lasted 1 month - 2-3 developed nose bleed lasted 2 months swelling ankles lasted 2wks - wheezing developed 1-2 after vaccine - 3 weeks after vaccine when the swelling decreased had pain + numbness in left foot.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Lymphadenitis
Clinical narrative: Left cervical lymphadenitis.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Loop electrosurgical excision procedure, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: I went in for the 1st of three Guardisil vaccinations. I had a recent previous pap smear that normal, no HPV, no abnormal cells, nothing. After another pap (after having the vaccine) it was found that I did in fact now have HPV and a lession that needed a LEEP procedure to be removed. My gyno was stunned at how quickly this lesion manifested and how dangerous it had become so very quickly. I was lucky to have it removed when I did as my gyno said one more week and more than likely it would have been cancerous. I now need pap tests every 6 months to make sure I don't get cervical cancer (from a shot that was meant to protect me from it). I now have HPV forever, and I never had it before I got the vaccine. Married, monogamous (as is spouse), how did I get it then? And is it a coincidence that it happened very shortly after the HPV vaccine was administered? I think not.  4/7/09 Received PCP vaccine record & medical records for 4/27/07. FINAL DX: none provided. Records reveal patient was new patient to practice & experienced menstrual cramps since 1/07 when out of BCPs.  Exam was WNL.   4/7/09 Received additional PCP records of 8/23/07. FINAL DX: chest pain, tachycardia Records reveal patient experienced chest pain, heart racing, SOB x 1 day.  Began right after starting new BCP.  Exam in office WNL.  Referred for echocardiogram & BCP d/c'd.  No further medical records or echocardiogram report available.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Culture positive, Erythema, Herpes zoster, Rash papular
Clinical narrative: Developed grouped papules and vesicles with a red base on his left shoulder on 2/17/09. He was treated with Valtrex for 7 days. Papules, vesicles and reddness resolved after treatment was completed.
Age: 12.0
Sex: F
Vaccine: HEPA, HPVX, MEN, TDAP
Symptoms: Disorientation, Dizziness, Dysarthria, Fall, Fatigue
Clinical narrative: Within 5 minutes of injection, arms felt heavy and tingly, tongue was tingling, felt nautious and felt dizzy, collapsed in waiting area but did not loose conciousness.  Was disoriented and was slurring while trying to talk, and pulse was 98.  Nurses arrived promptly and gave her orange juice and rested for 15 minutes.  Blood pressure was taken after the rest and pulse returned to normal 72.  Was released to go home.  Felt very tired and sleepy the rest of the evening.
Age: 12.0
Sex: F
Vaccine: HEPA, HPVX, MEN, TDAP
Symptoms: Heart rate increased, Immediate post-injection reaction, Nausea, Paraesthesia, Paraesthesia oral
Clinical narrative: Within 5 minutes of injection, arms felt heavy and tingly, tongue was tingling, felt nautious and felt dizzy, collapsed in waiting area but did not loose conciousness.  Was disoriented and was slurring while trying to talk, and pulse was 98.  Nurses arrived promptly and gave her orange juice and rested for 15 minutes.  Blood pressure was taken after the rest and pulse returned to normal 72.  Was released to go home.  Felt very tired and sleepy the rest of the evening.
Age: 12.0
Sex: F
Vaccine: HEPA, HPVX, MEN, TDAP
Symptoms: Sensation of heaviness, Somnolence
Clinical narrative: Within 5 minutes of injection, arms felt heavy and tingly, tongue was tingling, felt nautious and felt dizzy, collapsed in waiting area but did not loose conciousness.  Was disoriented and was slurring while trying to talk, and pulse was 98.  Nurses arrived promptly and gave her orange juice and rested for 15 minutes.  Blood pressure was taken after the rest and pulse returned to normal 72.  Was released to go home.  Felt very tired and sleepy the rest of the evening.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: 49 yo WF was given IM Pneumovax in left detoid on 3/2/09 at clinic visit for cough and sore throat. RN reported using one inch 25 gauge needle and proper technique. Pt voiced no concerns at the time the injection was given but developed fever and redness, swelling, and pain in the left arm on 3/3/09. Pt treated self with Tylenol alternating with Motrin every 4 hours. Returned to clinic 3/5 f/u. On assessment, pt's L upper arm from a couple of inches above the elbow up to the shoulder was red, swollen, warm to touch and painful. Temp 98.8. Augmentin 875/125 PO bid for 10 days prescribed. Pt will f/u in clinic in 6 days.
Age: 67.0
Sex: M
Vaccine: DT, PPV
Symptoms: Erythema, Feeling hot, Oedema peripheral
Clinical narrative: redm wram swollen right bicep. treated with local care only, observation
Age: 25.0
Sex: F
Vaccine: TYP, YF
Symptoms: Pruritus, Rash maculo-papular, Urticaria
Clinical narrative: RECEIVED YELLOW FEVER VACCIN SQ, NOTICED REACTION SEVERAL DAYS LATER. REACTION CONSISTED OF URTICARIAL REACTION (MACULAR, PAPULAR, 3 INCH DIAMETER, WITH PRURITIS).                       PT PRESENTED TO CLINIC WITH SYMPTOMS 2/1/09 AND WAS GIVEN DIPHENHYDRAMINE 25MG PO 1-2 PO Q4-6 PRN & PREDNISONE 20MG TID FOR 3 DAYS, THEN TAPER OVER 6 DAYS.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Localized wheal (3 cm x 1 cm) and flare (5 cm x 6 cm).  Started within 5 minutes of vaccination.  At 10 minutes was still spreading without systemic symptoms.  Treated with Benadryl 1.25 mg/kg with good response.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: PATIENT DEVELOPED REDNESS TO INJECTION SITE (RIGHT ARM) WITH INDURATION AND SENSITIVE TO TOUCH
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Pain in extremity
Clinical narrative: Patient received flu shot at unknown pharmacy 6 months ago.  Felt immediate pain in Left lateral upper arm, and pain has persisted to the present day.  No loss of motor function.
Age: 1.25
Sex: F
Vaccine: DTAP, PNC
Symptoms: Erythema, Eye swelling, Rash, Urticaria
Clinical narrative: Developed swelling of right eye with redness 1 hour after Immunizations, then developed swelling of left eye and approx 2 hours later had hives on face, neck, back, arms and later developed flat red rash on legs.  Child seen in Urgent Care & given Prednisone and Benadryl.  All symptoms subsided by evening of following day.
Age: 1.33
Sex: U
Vaccine: FLU3, HEPA
Symptoms: Injection site erythema
Clinical narrative: localized redness for two days at site of injection. Right thigh.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy
Clinical narrative: Mother called and reported that patient was pregnant when she received her third Gardisil.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: multiple wheals around injection site, right shoulder area, and trunks. Hydrocortison cream and Loratadine given.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Convulsion, Crying, Emotional distress, Hyperventilation, Immediate post-injection reaction
Clinical narrative: Austen was very anxious when given his immunizations at 11:30am.  Immediately after he became pale and c/o nausea.  Less than 5 minutes after vaccination, at about 11:35am, he became unresponsive, lost consciousness and convulsed.  The convulsion lasted less than 5 seconds after which he regained consciousness and appeared visibly upset by crying.  His respirations increased and he began to hyperventilate.  He was able to follow commands to breath into a paper bag slowly.  His pulse remained normal throughout the episode.  He experienced no allergic response or fall.  He stayed in the office for 30 minutes and was able to walk to his mother's car at 12noon.  She took him to his family doctor where he was examined.  Mother reported exam was normal.  When I spoke with her around 2pm, he was sleeping comfortably at home.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Loss of consciousness, Nausea, Pallor, Respiratory rate increased, Unresponsive to stimuli
Clinical narrative: Austen was very anxious when given his immunizations at 11:30am.  Immediately after he became pale and c/o nausea.  Less than 5 minutes after vaccination, at about 11:35am, he became unresponsive, lost consciousness and convulsed.  The convulsion lasted less than 5 seconds after which he regained consciousness and appeared visibly upset by crying.  His respirations increased and he began to hyperventilate.  He was able to follow commands to breath into a paper bag slowly.  His pulse remained normal throughout the episode.  He experienced no allergic response or fall.  He stayed in the office for 30 minutes and was able to walk to his mother's car at 12noon.  She took him to his family doctor where he was examined.  Mother reported exam was normal.  When I spoke with her around 2pm, he was sleeping comfortably at home.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: 5cm x 5 cm Red, Swollen, Hardness, warm to touch. Patient admitted to scratching the arm at the injection site.
Age: 62.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness
Clinical narrative: received the vaccine at 3pm, february 10, 2009.  Suddenly became very dizzy at 4:30 pm.  The extreme dizziness slowly subsided and was gone by 9:30 pm that same evening.  I sat quietly, but lying down increased the dizziness.  there were no recurrences and no medical care was needed.
Age: 0.15
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Crying
Clinical narrative: Unconsolable crying for 6 hours after vaccine administration.  No treatment.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Patient received pneumococcal vaccine on 11/17/2008 and 2 days later complained that his right upper arm was hot to the touch red, and swollen. PAC recommended icing the arm and taking Tylenol for the pain.
Age: 1.3
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Erythema and swelling of L upper thigh measuring 8 x 7 cm oval.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, HPV4
Symptoms: Computerised tomogram, Convulsion, Electrocardiogram, Fall, Posture abnormal
Clinical narrative: Pt had seizure while sitting and eating, talking neck twisted and fell to the floor while @ grandmother's house lasted 2min. Multiple seizures since then. Had 3 in one day on 6-11-08 while at school.  3/11/09 MR received from PCP from 9/2007-2/2009. WCC 9/18/07 with normal exam, well adolecent, no problems on 9/18/07. Several visits for bronchitis 12/07 and 5/08. Seen in f/u of tonic seizure which occured 6/5/08. 3 seizures 6/9/08. Referred stat to neurologist. 5 seizures 10/2008. 5 seizures Jan-Feb 2009. Neuro consult dated 12/11/08. 1st seizure lasting 2-3" with post-ictal confusion, agitation and amnesia. More recently pt reports increased sleep, problems with processing, and paresthesias. Grades have recently declined.  3/26/09 Neuro consult received as above.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, HPV4
Symptoms: Convulsion
Clinical narrative: Pt had seizure while sitting and eating, talking neck twisted and fell to the floor while @ grandmother's house lasted 2min. Multiple seizures since then. Had 3 in one day on 6-11-08 while at school.  3/11/09 MR received from PCP from 9/2007-2/2009. WCC 9/18/07 with normal exam, well adolecent, no problems on 9/18/07. Several visits for bronchitis 12/07 and 5/08. Seen in f/u of tonic seizure which occured 6/5/08. 3 seizures 6/9/08. Referred stat to neurologist. 5 seizures 10/2008. 5 seizures Jan-Feb 2009. Neuro consult dated 12/11/08. 1st seizure lasting 2-3" with post-ictal confusion, agitation and amnesia. More recently pt reports increased sleep, problems with processing, and paresthesias. Grades have recently declined.  3/26/09 Neuro consult received as above.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Convulsion, Fatigue
Clinical narrative: 3/4/2009 at 7:30pm child had a seizure lasting about 1.5 minutes. No fever. Complained of feeling tired before and after taken ER treated and has a follow-up appointment.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Rash vesicular
Clinical narrative: Had 2 doses of VARIVAX, developed 20-30 classic varicella lesions over axillary/trunk area, no cough, coryza, URI symptoms, otherwise well, lesions and associated pruritis - no impetigo.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Injection site erythema
Clinical narrative: After receiving all ten shots - PENTACEL, ENGERIX and ROTATEQ. Pt noted to have significant erythematosis lower extremities that lasted few minutes then Pt completely recovered.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, CSF protein increased, Facial paresis, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Pain, tingling and weakness in legs, feet, arms, hands and face; first noticed numbness in feet end of October, 2008. Progressed to legs, arms, hands and then face. Also progressively got worse and more painful. Diagnosis GUILLAN BARRE.  3/16/09 Neurology consult received with assessment post-vaccinal AIDP (GBS). ROS (+) for difficulty sleeping, blurring of eyes, arthritis, rash, itching, tingling, weakness, numbness.  PE (+) for sensory disturbances toes, ankles and fingers and dysthesias to heels and fingertips. DTRS absent L achilles, depressed tricep, brachiorad, and R achilles. Has had 2 rounds of IVIG with lack of response.  3/31/09 Neuro consults dated 12/2/08 to 3/12/09 received.  Pt presented to neuro with 3 week hx of foot numbness and feeling swollen, tightness in the lower legs and numbness which progressed to the fingertips and hands. PE (+) for absent DTRs in UE and brisk DTRs in LE. Sensory loss in LEs. DX: Acute demyelinating polyneuropathy. 4/14/09 ER note from 12/2/08 received.  Pt sent in by PCP for testing r/t c/o acute numbness to all extremities.  Not seen by MD, only in for testing/spinal tap. Labs as above.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Lumbar puncture, Muscular weakness, Nuclear magnetic resonance imaging, Pain, Paraesthesia
Clinical narrative: Pain, tingling and weakness in legs, feet, arms, hands and face; first noticed numbness in feet end of October, 2008. Progressed to legs, arms, hands and then face. Also progressively got worse and more painful. Diagnosis GUILLAN BARRE.  3/16/09 Neurology consult received with assessment post-vaccinal AIDP (GBS). ROS (+) for difficulty sleeping, blurring of eyes, arthritis, rash, itching, tingling, weakness, numbness.  PE (+) for sensory disturbances toes, ankles and fingers and dysthesias to heels and fingertips. DTRS absent L achilles, depressed tricep, brachiorad, and R achilles. Has had 2 rounds of IVIG with lack of response.  3/31/09 Neuro consults dated 12/2/08 to 3/12/09 received.  Pt presented to neuro with 3 week hx of foot numbness and feeling swollen, tightness in the lower legs and numbness which progressed to the fingertips and hands. PE (+) for absent DTRs in UE and brisk DTRs in LE. Sensory loss in LEs. DX: Acute demyelinating polyneuropathy. 4/14/09 ER note from 12/2/08 received.  Pt sent in by PCP for testing r/t c/o acute numbness to all extremities.  Not seen by MD, only in for testing/spinal tap. Labs as above.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Ultrasound scan normal
Clinical narrative: Pain, tingling and weakness in legs, feet, arms, hands and face; first noticed numbness in feet end of October, 2008. Progressed to legs, arms, hands and then face. Also progressively got worse and more painful. Diagnosis GUILLAN BARRE.  3/16/09 Neurology consult received with assessment post-vaccinal AIDP (GBS). ROS (+) for difficulty sleeping, blurring of eyes, arthritis, rash, itching, tingling, weakness, numbness.  PE (+) for sensory disturbances toes, ankles and fingers and dysthesias to heels and fingertips. DTRS absent L achilles, depressed tricep, brachiorad, and R achilles. Has had 2 rounds of IVIG with lack of response.  3/31/09 Neuro consults dated 12/2/08 to 3/12/09 received.  Pt presented to neuro with 3 week hx of foot numbness and feeling swollen, tightness in the lower legs and numbness which progressed to the fingertips and hands. PE (+) for absent DTRs in UE and brisk DTRs in LE. Sensory loss in LEs. DX: Acute demyelinating polyneuropathy. 4/14/09 ER note from 12/2/08 received.  Pt sent in by PCP for testing r/t c/o acute numbness to all extremities.  Not seen by MD, only in for testing/spinal tap. Labs as above.
Age: 1.6
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Oedema peripheral
Clinical narrative: 2 days later (after 3rd DTaP) leg from thigh to knee swollen and red spotty spot on inner thigh not at injection site but near it, no fever, warm, tender.
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient had swelling and soreness to injection site. She also had about 6 inches of redness around site.
Age: 26.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Infection, Injection site pain, Injection site swelling, Purulent discharge
Clinical narrative: Green drainage- painful, swollen around injection site.  (Secondary Infection)
Age: 26.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Culture positive, Injection site discharge, Injection site pain, Injection site swelling, Staphylococcal infection
Clinical narrative: Green drainage- painful, swollen around injection site.  (Secondary Infection)
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Back pain, Blood test normal, Convulsion, Electroencephalogram normal
Clinical narrative: Information has been received from a consumer concerning her 19 year old daughter with penicillin and sulfa allergy who on 25-MAR-2008 was vaccinated with the first dose of GARDASIL.  Immediately after getting the vaccine her daughter had a severe backache, severe headaches, a urinary tract infection, a kidney infection, seizures, hair loss and bruising.  On 6-MAY-2008 the patient received the second dose of GARDASIL and then had seizures everyday.  It was also reported that the patient tested positive for dysplasia after being vaccinated with the GARDASIL vaccine.  The reporter stated her daughter almost died from the seizure.  On an unspecified date the patient was hospitalized.  A complete blood work was performed and everything was normal other than a vitamin deficiency.  The patient did not receive the third dose of GARDASIL vaccine and she continues to get seizures about every six weeks.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Headache, Pain, Smear cervix abnormal, Urinary tract infection
Clinical narrative: Information has been received from a consumer concerning her 19 year old daughter with penicillin and sulfa allergy who on 25-MAR-2008 was vaccinated with the first dose of GARDASIL.  Immediately after getting the vaccine her daughter had a severe backache, severe headaches, a urinary tract infection, a kidney infection, seizures, hair loss and bruising.  On 6-MAY-2008 the patient received the second dose of GARDASIL and then had seizures everyday.  It was also reported that the patient tested positive for dysplasia after being vaccinated with the GARDASIL vaccine.  The reporter stated her daughter almost died from the seizure.  On an unspecified date the patient was hospitalized.  A complete blood work was performed and everything was normal other than a vitamin deficiency.  The patient did not receive the third dose of GARDASIL vaccine and she continues to get seizures about every six weeks.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Visual impairment
Clinical narrative: Information has been received from a consumer concerning her 19 year old daughter with penicillin and sulfa allergy who on 25-MAR-2008 was vaccinated with the first dose of GARDASIL.  Immediately after getting the vaccine her daughter had a severe backache, severe headaches, a urinary tract infection, a kidney infection, seizures, hair loss and bruising.  On 6-MAY-2008 the patient received the second dose of GARDASIL and then had seizures everyday.  It was also reported that the patient tested positive for dysplasia after being vaccinated with the GARDASIL vaccine.  The reporter stated her daughter almost died from the seizure.  On an unspecified date the patient was hospitalized.  A complete blood work was performed and everything was normal other than a vitamin deficiency.  The patient did not receive the third dose of GARDASIL vaccine and she continues to get seizures about every six weeks.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Alopecia, Back pain, Contusion, Convulsion, Dysplasia
Clinical narrative: Information has been received from a consumer concerning her 19 year old daughter with penicillin and sulfa allergy who on 25-MAR-2008 was vaccinated with the first dose of GARDASIL.  Immediately after getting the vaccine her daughter had a severe backache, severe headaches, a urinary tract infection, a kidney infection, seizures, hair loss and bruising.  On 6-MAY-2008 the patient received the second dose of GARDASIL and then had seizures everyday.  It was also reported that the patient tested positive for dysplasia after being vaccinated with the GARDASIL vaccine.  The reporter stated her daughter almost died from the seizure.  On an unspecified date the patient was hospitalized.  A complete blood work was performed and everything was normal other than a vitamin deficiency.  The patient did not receive the third dose of GARDASIL vaccine and she continues to get seizures about every six weeks.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Hypovitaminosis, Immediate post-injection reaction, Kidney infection, Laboratory test abnormal
Clinical narrative: Information has been received from a consumer concerning her 19 year old daughter with penicillin and sulfa allergy who on 25-MAR-2008 was vaccinated with the first dose of GARDASIL.  Immediately after getting the vaccine her daughter had a severe backache, severe headaches, a urinary tract infection, a kidney infection, seizures, hair loss and bruising.  On 6-MAY-2008 the patient received the second dose of GARDASIL and then had seizures everyday.  It was also reported that the patient tested positive for dysplasia after being vaccinated with the GARDASIL vaccine.  The reporter stated her daughter almost died from the seizure.  On an unspecified date the patient was hospitalized.  A complete blood work was performed and everything was normal other than a vitamin deficiency.  The patient did not receive the third dose of GARDASIL vaccine and she continues to get seizures about every six weeks.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Urinary tract infection
Clinical narrative: Information has been received from a consumer concerning her 19 year old daughter with penicillin and sulfa allergy who on 25-MAR-2008 was vaccinated with the first dose of GARDASIL.  Immediately after getting the vaccine her daughter had a severe backache, severe headaches, a urinary tract infection, a kidney infection, seizures, hair loss and bruising.  On 6-MAY-2008 the patient received the second dose of GARDASIL and then had seizures everyday.  It was also reported that the patient tested positive for dysplasia after being vaccinated with the GARDASIL vaccine.  The reporter stated her daughter almost died from the seizure.  On an unspecified date the patient was hospitalized.  A complete blood work was performed and everything was normal other than a vitamin deficiency.  The patient did not receive the third dose of GARDASIL vaccine and she continues to get seizures about every six weeks.  Additional information has been requested.
Age: 37.0
Sex: M
Vaccine: SMALL
Symptoms: Chills, Injection site cellulitis, Myalgia, Pyrexia, Somnolence
Clinical narrative: Fever, Chills, Myalgia, Drowsiness, Cellulitis around injection site.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Oedema peripheral
Clinical narrative: Pain and swelling in Right upper arm after 4 year old received vaccines.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling in Right upper arm after 4 year old received vaccines.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV5, DTAPHEPBIP, HIBV, RV5
Symptoms: Intussusception, Surgery
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 5 month old male patient who on 27-JAN-2009 was vaccinated with the second dose of ROTATEQ orally, the second dose of ACTHIB (Lot UF472AB) intramuscularly and the second dose of PEDIARIX (Lot AC21B149A) intramuscularly. On 28-JAN-2009 the patient developed intussusception and required surgical repair. The listing indicated that one or more of the events required hospitalization and were considered to be immediately life-threatening. No further information is available. VAERS ID number 338639. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the research center and was released. The original reporting source was not provided.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Urticaria
Clinical narrative: Hives all over body, very large and raised. Benadryl worked somewhat. Zyrtec (20mg) stopped the reaction almost totally. However, after about a week or so, they reoccurred just as severely as at first. Took Tylenol when I felt warm, along with the Zyrtec and that also worked for a few days. After a massage today, large areas of hives broke out on my thighs and neck.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test negative, Vaginal haemorrhage
Clinical narrative: Information has been received from a licensed practical nurse concerning a 26 year old female with no known medical history and drug allergies, who on 12-DEC-2008 was vaccinated with a first dose of GARDASIL (lot # 660620/0571X) on 12-FEB-2009.  The patient received a 0.5 mL second dose of GARDASIL (lot # 661764/0650X), intramuscularly.  There was no concomitant medication.  It was reported that the patient was pregnant.  It was noted that the patient had experienced vaginal spot bleeding that was bright red.  It was also reported that the patient miscarried.  She was in her first trimester and probably only a couple weeks pregnant.  Beta levels were negative and she will not require a dilation and curettage procedure.  The patient sought medical attention through a phone call to the practice.  Upon internal review, miscarried was determined to be an other important medical event.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain, Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test negative, Urine human chorionic gonadotropin negative
Clinical narrative: Information has been received from a physician assistant and a licensed practical nurse, for GARDASIL, a Pregnancy Registry product, concerning a 20 year old female patient with asthma and no known drug allergies or reactions who on 02-DEC-2008 (after a negative pregnancy test) was vaccinated with the first 0.5 ml IM dose of GARDASIL (lot #0152X). Concomitant therapy included albuterol. It was noted that the patient got pregnant around the end of December 2008. About 6-7 weeks ago, the patient was assumed to undergo a miscarriage. She experienced abdominal pain. On 04-JAN-2009 the patient was seen at a hospital. On 06-JAN-2009 the patient was seen at the emergency room, experiencing a threatening spontaneous abortion, with no evidence of gestation sack and no evidence of embryonic pole. She was given birth control after the miscarriage. It was reported that unspecified blood was drawn and testing was done. On 26-JAN-2009 the patient had a HCG quant level of 16, and on 03-FEB-2009 a quant level of 5. But the patient never got her period. On 16-FEB-2009 physician assistant spoke with the patient's physician's office to confirm her lack of pregnancy and gave her a pregnancy test with negative result. On 16-FEB-2009 the patient received the second 0.5 ml IM dose of GARDASIL (lot #01423X). The patient also had an adverse event after this second dose (WAES # 0903USA00527). Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Drug exposure during pregnancy, Muscle spasms, Pregnancy, Ultrasound scan abnormal
Clinical narrative: Information has been received from a physician assistant and a licensed practical nurse, for GARDASIL, a Pregnancy Registry product, concerning a 20 year old female patient with asthma and no known drug allergies or reactions who on 02-DEC-2008 (after a negative pregnancy test) was vaccinated with the first 0.5 ml IM dose of GARDASIL (lot #0152X). Concomitant therapy included albuterol. It was noted that the patient got pregnant around the end of December 2008. About 6-7 weeks ago, the patient was assumed to undergo a miscarriage. She experienced abdominal pain. On 04-JAN-2009 the patient was seen at a hospital. On 06-JAN-2009 the patient was seen at the emergency room, experiencing a threatening spontaneous abortion, with no evidence of gestation sack and no evidence of embryonic pole. She was given birth control after the miscarriage. It was reported that unspecified blood was drawn and testing was done. On 26-JAN-2009 the patient had a HCG quant level of 16, and on 03-FEB-2009 a quant level of 5. But the patient never got her period. On 16-FEB-2009 physician assistant spoke with the patient's physician's office to confirm her lack of pregnancy and gave her a pregnancy test with negative result. On 16-FEB-2009 the patient received the second 0.5 ml IM dose of GARDASIL (lot #01423X). The patient also had an adverse event after this second dose (WAES # 0903USA00527). Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested.