chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dysphagia, Flushing, Throat tightness
Clinical narrative: Facial flushing, difficulty swallowing, throat tight. Brought to Emergency Dept.
Age: 24.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Syncope
Clinical narrative: Within a minute of vaccinations patient fainted. He recovered in about 5-10 seconds but was still very dizziness. Dizziness passed within 15-20 minutes. Patient laid in the pharmacy for 40 minutes and was monitored for an hour after dizziness passed. Patient was fine after this time. Followed up with patient 12/20/09 had no adverse effect.
Age: 55.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Ear disorder, Flushing, Nausea
Clinical narrative: Pt. was complained of some adverse reactions, she claims when she returned to the pharmacy 1 day later. After receiving shot she said a hour later her ear popped and after 8 hours she felt flushed, Dz and sick to her stomach, however, she did not vomit. At 24 hours, she was still Dz and sick to her stomach. I informed her to talk to her doctor right away.
Age: 30.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Drug exposure during pregnancy, Injection site pain
Clinical narrative: Persistent pain at injection site. (L deltoid 0.25 ml preserv free - pregnancy).
Age: 70.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Chills, Fatigue, Local swelling, Pain in jaw
Clinical narrative: Client received H1N1 in a mass vac's clinic and woke up next morning with jaw pain and neck swelling on the same side as the injection arm (Left). Called H.D. to report and we referred her to her physician (reported fatigue and chills to.) Client seen and tk with Benadryl for II weeks.
Age: 26.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Blood pressure normal, Dizziness, Feeling hot, Vision blurred, Vomiting
Clinical narrative: Adverse Event: (1) Hot feeling (2) Dizzy, blurry vision (3) Vomiting. Treatment: B.P. checked (normal), cold drink, ice pack.
Age: 6.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site urticaria, Lip swelling, Rash, Urticaria
Clinical narrative: Received vaccine at around 1:25 PM and by the time they reached home, hives were evident starting at site of injection (left arm) up her neck to face down chest and back: Rash also evident behind ears not much on face. Lips sl. swollen save BENADRYL to daughter and called child's pediatrician - no respiratory problems.
Age: 38.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Chills, Dyspnoea, Erythema, Full blood count normal, Gait disturbance
Clinical narrative: Thursday morning, 12/10/09, around 6pm started to have fever, headache, difficulty in walking, red face, rash on skin. The symptoms continued and on the third day the fever did not go down. Had a severe infection in the throat, slightly fast pulse, nausea, body aches, shivers. When had fever had difficulty breathing. On Friday, 12/18/09, 8 days after the administration of the vaccine finally felt better. Visited an ER and 2 private doctors. Was administered CIPRO and PANADOL.
Age: 38.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Headache, Heart rate increased, Nausea, Pain, Pharyngitis
Clinical narrative: Thursday morning, 12/10/09, around 6pm started to have fever, headache, difficulty in walking, red face, rash on skin. The symptoms continued and on the third day the fever did not go down. Had a severe infection in the throat, slightly fast pulse, nausea, body aches, shivers. When had fever had difficulty breathing. On Friday, 12/18/09, 8 days after the administration of the vaccine finally felt better. Visited an ER and 2 private doctors. Was administered CIPRO and PANADOL.
Age: 38.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Pyrexia, Rash
Clinical narrative: Thursday morning, 12/10/09, around 6pm started to have fever, headache, difficulty in walking, red face, rash on skin. The symptoms continued and on the third day the fever did not go down. Had a severe infection in the throat, slightly fast pulse, nausea, body aches, shivers. When had fever had difficulty breathing. On Friday, 12/18/09, 8 days after the administration of the vaccine finally felt better. Visited an ER and 2 private doctors. Was administered CIPRO and PANADOL.
Age: 2.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Laboratory test, Pyrexia, Rhinorrhoea, Tremor, Urine analysis
Clinical narrative: 12/16/09 Late morning, mom noted child shaking. Brought to office, T 102.6->105.8. MOTRIN given. Clear rhinorrhea otherwise no other symptoms. UA C&S ordered. Better 12/17 day but F to 103.3 in PM, afeb 12/18/09.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Flatulence, Injection site pain, Mobility decreased
Clinical narrative: Patient describes onset of pain in left shoulder soon after injection; severe, radiating down arm, making it impossible to move arm @ shoulder; then radiating into left breast and upper back. Symptoms have persisted x 9 days now. Also had some chills and gassiness that resolved the next day.
Age: 15.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Loss of consciousness, Mydriasis, Pallor, Unresponsive to stimuli
Clinical narrative: About 5 min after receiving vaccine on approach to vehicle, mother states pt went white and lost consciousness. When I arrived outside, pt was pale and unresponsive for about 10-15 sec. at which time he regain some composure and became A/O x 3, though pupils were still dilated. Pt was moved to tx rm where he was monitored for 20 min and release by Dr.
Age: 20.0
Sex: F
Vaccine: TYP
Symptoms: Syncope
Clinical narrative: Headache, nausea, vomiting after 3rd dose of oral typhoid, near syncope 2 days after 4th dose.
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 1.17
Sex: M
Vaccine: UNK
Symptoms: Full blood count normal, Irritability, Loss of consciousness, Pallor, Posture abnormal
Clinical narrative: Starting at 07:30 10-22-09. 1. Pale. 2. Limp-passed out. 3. Very fussy. Follow-up: This was administered at Health Department. When phoned for information the office was unable to provide the information due to the rapid response of getting the H1N1 vaccination, they were behind on the data entry process.
Age: 57.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Chills, Dyspnoea, Pyrexia
Clinical narrative: 12/5/09, 2:30pm sudden onset chills, fever 101-102 degrees. Took flu medication OTC at night and went to bed at 5pm. Increased chills, fever, shortness of breath during night. Improved by 10:00 AM 12/6/09. Improving but weak at 3pm.
Age: 59.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Diarrhoea haemorrhagic, Drug hypersensitivity, Nausea, Vomiting
Clinical narrative: Patient received H1N1, and seasonal Flu injections at 11 am 12/22/09. By 9 pm that night she developed severe nausea and vomiting, and diarrhea. This am 12/23/09 she has bloody diarrhea with clots of blood.
Age: 43.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event
Clinical narrative: None reported
Age: 9.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Mydriasis, Pallor, Staring, Syncope, Unresponsive to stimuli
Clinical narrative: A few minutes after receiving the vaccine, his older brother fainted and within a few minutes after that patient fainted as well. Patient went pale, pupils dilated and though eyes remained open, patient was unresponsive for about 10 sec. After a few minutes in Trendelenburg, color returned and patient went back to normal.
Age: 47.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site pain, Neck pain, Pain
Clinical narrative: 4-5 days after admin. of vaccine, I experienced pain from bottom of left deltoid to behind left ear all the way up the side of my neck. Pain lasted x1 wk. Missed 1 day of work.
Age: 16.0
Sex: F
Vaccine: TD
Symptoms: Lip swelling, Paraesthesia oral, Throat irritation
Clinical narrative: Scratchy throat, "tingly mouth/lips", lips swelling. Treated with BENADRYL for two days (given by parent).
Age: 3.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Body temperature normal, Cough, Headache, Pyrexia, Urticaria
Clinical narrative: Patient c/o a headache 10 min. after shot admin. Temp was taken=102 degrees. Wet cough and fever x 3 days. 11/5 developed hives, afebrile. Hives x 5 days. Hives responded to CLARITAN. Cough x 3 wks.
Age: 71.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Cough, Immediate post-injection reaction, Nasopharyngitis
Clinical narrative: Immediately following vaccination patient started having cold symptoms noted particularly by severe coughing with no relief.
Age: 55.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Hypoaesthesia, Muscle contracture, Muscular weakness
Clinical narrative: Weakness, numbness in left arm after receiving injection, "contractures" the next day.
Age: 3.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Immediate post-injection reaction, Pain in extremity, Paraesthesia
Clinical narrative: Patient complained of tingling in feet immediately after administration. Two days after admin, patient complained of leg pain-generalized.
Age: 55.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Malaise
Clinical narrative: Chills, headache, nausea, tired, just a real sick and achy feeling- later had diarrhea. Went home and went to bed.
Age: 55.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Nausea, Pain
Clinical narrative: Chills, headache, nausea, tired, just a real sick and achy feeling- later had diarrhea. Went home and went to bed.
Age: 73.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Bone pain, Myalgia, Nausea, Vomiting
Clinical narrative: Had vaccination Friday afternoon on Saturday had symptoms of nausea & vomiting, also extreme soreness/ achiness of muscles also soreness of bones of vertebrae down to ankles still sore as of Monday.
Age: 49.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Asthenia, Dizziness, Erythema
Clinical narrative: C/o weakness, lightheadedness and redness above injection site, up neck and down back x 2 hours.
Age: 39.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Dizziness, Fatigue, Nausea, Vertigo
Clinical narrative: Dizzy, room spinning, nauseous, light headed, excessively tired.
Age: 8.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Injection site papule, Injection site rash
Clinical narrative: Papular rash noticed 24 hours after shot. Rash located on same area where vaccine was given.
Age: 17.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Headache, Malaise, Somnolence
Clinical narrative: Received on 12/12/09 - on 12/15/09 - light headed not feeling well headache since 12/16/09 - sleeping most of the day - denies fever without vomiting - called FMD 12/17/09 - to go to doctor 12/21 if no change of symptoms. 12/21/09 per mother was in school on 12/21/09.
Age: 30.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Asthenia, Dizziness, Drug exposure during pregnancy, Eye pruritus, Pruritus
Clinical narrative: Received H1N1 injection. About 20-30 minutes after injection she complained of itchy nose and eyes, started sneezing. Moved to exam room. BP taken sitting, L arm 102/40. C/O feeling weak and dizzy. Laid her on exam table-c/o tightness in throat. 911 called and paramedics came, BP 114/70, P=88. Improved. Paramedics had her sit up-respiratory symptoms were resolving. Client reported feeling better. Paramedic suggested giving her BENADRYL. Client was given 25 mg tablet diphenhydramine in the office and sent home with 3 more 25 mg tablets diphenhydramine and instructed to take 1-2 tablets every 4-6 hours as needed. Client given crackers and juice as she stated she had not eaten. After 30 minutes more she left clinic.
Age: 30.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Sneezing, Throat tightness
Clinical narrative: Received H1N1 injection. About 20-30 minutes after injection she complained of itchy nose and eyes, started sneezing. Moved to exam room. BP taken sitting, L arm 102/40. C/O feeling weak and dizzy. Laid her on exam table-c/o tightness in throat. 911 called and paramedics came, BP 114/70, P=88. Improved. Paramedics had her sit up-respiratory symptoms were resolving. Client reported feeling better. Paramedic suggested giving her BENADRYL. Client was given 25 mg tablet diphenhydramine in the office and sent home with 3 more 25 mg tablets diphenhydramine and instructed to take 1-2 tablets every 4-6 hours as needed. Client given crackers and juice as she stated she had not eaten. After 30 minutes more she left clinic.
Age: 1.27
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Tremor
Clinical narrative: Received a call from mom stating pt had H1N1 #2 this am and mom noticed her hands and body trembling at lunchtime. Pt ate lunch. No diff breathing or other sxs. Mom to cb for ongoing pos.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Nausea
Clinical narrative: (1) Nauseas - (2) Dolor de cabeza
Age: 32.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Drug exposure during pregnancy, Foetal heart rate abnormal, Intra-uterine death
Clinical narrative: Pt. received H1N1 vaccine at 14 wks. Fetal heart tones present 5 days later at MD appt. At next appt (12/23/09), fetal heart tones absent (18 wks). US confirmed fetal demise. Delivered 12/26/09.
Age: 9.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Dyspnoea, Rash macular, Swelling face, Throat tightness, Urticaria
Clinical narrative: Developed blotchy, puffy face & hives at neck, back & abdomen. Throat felt tight. Some difficulty breathing. Given epinephrine & BENADRYL by ambulance. Then ORAPRED/BENADRYL.
Age: 9.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Fall
Clinical narrative: 6 pm child received vaccine, IM then fell on floor. Parents at side and states child has not eaten. Patient encouraged to eat crackers and drink water.
Age: 13.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Incorrect drug dosage form administered
Clinical narrative: Received 2009 H1N1 FLUMIST. Consent form indicates person has asthma. Vaccinator gave wrong type of vaccine.
Age: 9.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Abdominal discomfort, Feeling abnormal
Clinical narrative: Sitting on steps friend told her 'something' about shot. Reading side effects sheet. Stomach upset. Saw blood on palm. Feeling "yucky."
Age: 8.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Cyanosis, Dizziness, Feeling hot, Pallor
Clinical narrative: Felt hot, dizzy. Eased to floor. Pale, cyanotic, awake & alert. Elem. 12/9/09.
Age: 8.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Incorrect drug dosage form administered
Clinical narrative: Child with diabetes received 2009 H1N1 Flu Mist. Meaning received wrong type of vaccine. No immediate physiologic reaction.
Age: 16.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Asthenia, Headache, Rhinorrhoea
Clinical narrative: "Feeling weak, my head feels stuffed or bloated and I got a runny nose". Sent to nurse office to call Mom/Dad.
Age: 16.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Angiofibroma, Computerised tomogram, Nasal cavity mass, Swelling face
Clinical narrative: Facial swelling L side nontender, nonerythematous. No respiratory distress. Follow up received 1/4/2010. Impression: Large mass occupying the nasal cavity, sphenoid sinus, extending minimally into the left orbit, and extending prominently through the left pterygopalatine fossa into the infratemporal and temporal fossa. The location is highly suggestive of a juvenile angiofibroma, though the enhancement pattern is somewhat aytpical. The location is atypical for an inverted papilloma, although the enhancement pattern is more suggestive of this diagnosis, this is thought unlikely. Other possiblilites including esthesioneuroblastoma, lyphoma and rhabdomyosarcoma merit consideration but the lack of intracranial extension, but there are features which are atypical for each of these diagnoses. Overall, a juvenile angiofibroma is most likely.
Age: 66.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Erythema, Immediate post-injection reaction, Pruritus, Vaccination complication
Clinical narrative: Even though has latex allergy did take H1N1 vaccine as seasonal vaccine taken at office didn't give her a reaction, after 2009 H1N1 administered small bandaid applied. She felt itching almost immediately. Area became red. Ice applied, Benadryl 50mg p.o stat. Reaction -2 1/2 x 2 1/2 Reaction dissipated. 15min after Benadryl sent home by cab.
Age: 9.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Electrocardiogram normal, Palpitations
Clinical narrative: Received H1N1 vaccine by injection on 12/11/09. On 12/12/09-patient c/o pounding in chest. Father took pulse=134 bpm. Parents took him to walk-in, saw Dr @ about 16:30, bland diet advised. No further treatment or evaluation. EKG done-normal. Mother states patient completely normal by 20:00.
Age: 13.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Chest discomfort, Urticaria
Clinical narrative: Within 1 hr of receiving H1N1 vaccination, developed few urticaria on mid-chest and c/o chest tightness. School nurse administered BENADRYL 50 mg PO, notified mother who took her to her pediatrician. Given Rx for oral BENADRYL, took one dose after initial dose given by school nurse. Mother states completely recovered by 11 PM same day. Mother stated pt has multiple antibiotic allergies, none listed on consent form and mother stated MD would have to be contacted to find out what they were. 12/31/09:  Primary care records received for date of service 12/16/09.    Presented with chest tightness and itchy rash, benadryl administered, sx. improving.  C/o feeling very tired.
Age: 14.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Grip strength decreased, Muscular weakness
Clinical narrative: My arm feels weak, I'm having problems holding my pencil tighter shot.  Starting feeling about 20 mins after shot.  Ice offered - student refused & wanted to return to class.  Instructed to return to nurse if needed.  Pt with equal strength bilat when squeezing this writers hand/fingers.
Age: 11.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Headache
Clinical narrative: Presented with c/o headache generalized in nature. All VS WNL for age. No other complaints per student. Observed 20 minutes. VS remained normal. Neuro checks normal. Mother called per school nurse to bring Tylenol/ stable to be treated by mom.
Age: 16.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Nausea
Clinical narrative: Pt c/o sudden onset of nausea, dizziness and "feel like I want to throw up". Injection site without redness or swelling. Denies cardiac or respiratory distress. Pt sent to nurse to call parent for pick up.
Age: 49.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Chapped lips, Cheilitis, Oral herpes
Clinical narrative: 1 wk after H1N1 developed sores on lips-they became chapped and then developed into "cold sores". Went to drug store-they gave him ABREVA and they are getting better.
Age: 17.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Dizziness, Lethargy, Nausea
Clinical narrative: Lightheaded, nauseous, lethargic.
Age: 3.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Rash, Urticaria
Clinical narrative: Approximately one hour after administration broke out in hives/rash around neck, body and legs. Treated with over the counter BENADRYL.
Age: 15.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Dizziness, Lethargy, Nausea, Oropharyngeal pain
Clinical narrative: Lightheaded, nausea, sore throat, lethargic. Sent to nurses office to call parent.
Age: 27.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Euphoric mood
Clinical narrative: Complained of dizziness before H1N1 injection which got worse at 20 minutes after injection. By 30 minutes, she reported feeling "high". BP taken 102/78. Laid client down for 20 min. Repeated BP 112/72, P=80. Given cracker and juice, left clinic 30 min feeling OK.
Age: 18.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Feeling hot
Clinical narrative: Lightheaded, hot. Sent to nurse office to call mom.
Age: 17.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Nausea
Clinical narrative: C/o nausea, dizziness, light headed. Last meal 9:00AM. Received injection ~ 8:15AM 12/8/09. Denies shortness of breath or chest pain no redness or swelling at injection site.
Age: 17.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Dizziness
Clinical narrative: Pt c/o lightheadedness while walking-started half hour "or so" after shot (vacc admin approx 08:30). Pt sent to nurse office to call mom-going home with mom.
Age: 57.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Abdominal pain, Chills, Diarrhoea, Erythema, Localised oedema
Clinical narrative: Pt describes fever of 102 degrees and chills 1st day after injection. Day 2 awoke with 5 inch circle that was 4 inches above site. C/O red/hot area with 20 sm circles within the larger area. Generalized malaise, abd cramping, diarrhea.
Age: 57.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Malaise, Pyrexia, Skin warm
Clinical narrative: Pt describes fever of 102 degrees and chills 1st day after injection. Day 2 awoke with 5 inch circle that was 4 inches above site. C/O red/hot area with 20 sm circles within the larger area. Generalized malaise, abd cramping, diarrhea.
Age: 6.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Erythema, Rash pruritic
Clinical narrative: Rash, red itchy bumps starting within 24 hrs. Spreading from thorax area to entire body over 25 day period. 5 mg PREDNISONE twice daily started 12-28-09.
Age: 16.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Light headed, nausea, headache.
Age: 16.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Nausea
Clinical narrative: Nausea. Sent to nurse's office.
Age: 15.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Feeling hot, Headache, Lacrimation increased
Clinical narrative: Current lightheaded, headache; hot face and teary eyes resolved. Sent to nurse's office.
Age: 13.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Anxiety, Dizziness, Headache, Hot flush, Peripheral coldness
Clinical narrative: Lightheaded then headache-cold hands, flush. Received shot, anxious prior to shot.
Age: 13.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Abdominal pain upper, Ear discomfort, Feeling hot, Hyperhidrosis
Clinical narrative: Sweaty, hot, ears clogged, stomach pain. Received mist.
Age: 11.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Asthma, Wrong drug administered
Clinical narrative: - Asthma -> Received mist by accident.
Age: 14.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Student fainted in chair after receiving vaccine. Transported by W/C to RN's office. Popsicle given, ice given. Rested x 30 min. Ret. to class.
Age: 14.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Syncope
Clinical narrative: Fainted in hallway after receiving vaccine. Walked to RN office. Rested x 15 minute. Popsicle given. Ret. to class.
Age: 5.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Wrong drug administered
Clinical narrative: Child received H1N1 FLUMIST 11/3/09.
Age: 7.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Syncope
Clinical narrative: Fainted after getting an injection.
Age: 53.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Biopsy skin, Blood culture negative, Laboratory test normal, Neuralgia, Pyrexia
Clinical narrative: Fever, vasculitis (full body) neuralgias commenced 11-27-09 thru present (12/15/09) on Prednisone, Allegra, Atarax.
Age: 53.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Red blood cell sedimentation rate increased, Vasculitis
Clinical narrative: Fever, vasculitis (full body) neuralgias commenced 11-27-09 thru present (12/15/09) on Prednisone, Allegra, Atarax.
Age: 40.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Cough, Dizziness, Headache, Muscular weakness, Nausea
Clinical narrative: Fever, sore throat, congestion, cough, blurry vision, sputum production; LE weakness; HA, nausea, lightheaded, dizzy, tingling in feet. Went to ED for MRI-negative; treated HA w/ ibuprofen-resolved; will flu with PCP.
Age: 40.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Nuclear magnetic resonance imaging normal, Oropharyngeal pain, Paraesthesia, Productive cough, Pyrexia
Clinical narrative: Fever, sore throat, congestion, cough, blurry vision, sputum production; LE weakness; HA, nausea, lightheaded, dizzy, tingling in feet. Went to ED for MRI-negative; treated HA w/ ibuprofen-resolved; will flu with PCP.
Age: 40.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Upper respiratory tract congestion, Vision blurred
Clinical narrative: Fever, sore throat, congestion, cough, blurry vision, sputum production; LE weakness; HA, nausea, lightheaded, dizzy, tingling in feet. Went to ED for MRI-negative; treated HA w/ ibuprofen-resolved; will flu with PCP.
Age: 36.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Nausea
Clinical narrative: Adult staff experienced feeling dizzy & nauseated after receiving H1N1 at school flu clinic. Assessment: BP 120/60, RR=18, HR=84. No SOB, wheezing, itching swelling or hives. Rested for 15 minutes, reported feeling better. Returned to class at 9:30am.
Age: 51.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pruritus, Rash generalised, Scratch
Clinical narrative: 11:00 Generalized rash and itching to H1N1 vaccine. Pt. c/o itching, she was observed scratching B UES and B LES. BENADRYL 50 mg was administered IM to R arm. Pt. reported no improvement after 30 minutes, Dr. was consulted to obtain permission to administer a 2nd dose of BENADRYL. Informed Dr. pt. weighs 80 kg. 11:35-2nd dose of BENADRYL 50 mg IM given to L arm. 11:55 AM Pt. reported feeling better. 12:00 Pt. went back to work.
Age: 8.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Pruritus, Rash
Clinical narrative: Approx. 30-40 min after H1N1 vaccine admin. intranasal, child developed flat rash on front and back of trunk. C/O of itching. NKA, no new foods or cleaning products used in home.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Ongoing achiness of left deltoid muscle, the one that received the vaccine.  Pain still present as of exam date 12/29/2009 but slowly resolving.
Age: 37.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Chest pain, Electrocardiogram
Clinical narrative: Presented with gradual onset of anterior chest pain that started approximately 30 minutes to 1 hour after receiving the H1N1 nasal mist vaccine this morning.  She was feeling well prior and during her vaccination. She returned to work and shortly after developed chest pain at her desk.The pain persisted so she called employee health and was instructed to go to ED.
Age: 57.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Asthenia, Atrophy, Back pain, Electromyogram abnormal, Musculoskeletal pain
Clinical narrative: Patient presented on 11/12/09 with left upper back and shoulder pain in trapezius area.  Patient also complains of left deltoid weakness and atrophy.  Patient had needle EMG of left upper extremity on 12/15/09 with the following findings: abnormal consistent with acute/subacute denervation with some motor unit loss and evidence of reinnervation in a upper brachial plexus/C5-5 nerve root distribution with sparing of the rhomboids (pure C5 nerve root innervation).  Needle EMG of the cervical paraspinal muscles at the C5-6 spinous process level was normal, but C7-T1 level muscles showed abnormal consistent with acute/subacute denervation.  Cervical paraspinal muscles may have significant segmental overlap, therefore these findings are most consistent C6 radiculopathy.  Patient had been treated with ibuprofen without response, Percocet without response, and some response to prednisone (decrease in pain to 2 out of 10, but weakness persisted).  Patient is now seeing physical therapy for modalities and strengthening.
Age: 57.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Nuclear magnetic resonance imaging abnormal, Radiculopathy, X-ray limb normal
Clinical narrative: Patient presented on 11/12/09 with left upper back and shoulder pain in trapezius area.  Patient also complains of left deltoid weakness and atrophy.  Patient had needle EMG of left upper extremity on 12/15/09 with the following findings: abnormal consistent with acute/subacute denervation with some motor unit loss and evidence of reinnervation in a upper brachial plexus/C5-5 nerve root distribution with sparing of the rhomboids (pure C5 nerve root innervation).  Needle EMG of the cervical paraspinal muscles at the C5-6 spinous process level was normal, but C7-T1 level muscles showed abnormal consistent with acute/subacute denervation.  Cervical paraspinal muscles may have significant segmental overlap, therefore these findings are most consistent C6 radiculopathy.  Patient had been treated with ibuprofen without response, Percocet without response, and some response to prednisone (decrease in pain to 2 out of 10, but weakness persisted).  Patient is now seeing physical therapy for modalities and strengthening.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HEP, PPV
Symptoms: Depressed level of consciousness, Emotional distress, Irritability, Myoclonus, Petit mal epilepsy
Clinical narrative: onset within 12 hrs of vaccination fever, irritability (unconsolable. within 48 hrs. myoclonic jerking noted . within 72hrs "petite mal absence-type episodes followed by decreased arousal for 24- 48 hrs.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HEP, PPV
Symptoms: Pyrexia
Clinical narrative: onset within 12 hrs of vaccination fever, irritability (unconsolable. within 48 hrs. myoclonic jerking noted . within 72hrs "petite mal absence-type episodes followed by decreased arousal for 24- 48 hrs.
Age: 5.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Influenza, Pyrexia, Rash
Clinical narrative: My state health department encouraged me to report this.  I am unsure of the approximate dates of onset.  My 5 yr old daughter developed a rash 3-4 weeks after her second h1n1 vaccine.  It has continued approximately 3 weeks to date.  It has not yet been diagnosed.  About 10 days into the rash, she developed a fever and was diagnosed by rapid test with influenza A.  She began tamiflu.  The rash is still constant, spreading to her back of neck and elbows and forearms.  I am uncertain whether this is a side effect of vaccine.  Please help.
Age: 34.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Headache
Clinical narrative: C/O frontal HA approx. 30 minutes after  H1N1 nasal spray vaccine.
Age: 47.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Feeling hot, Rash erythematous, Tongue disorder
Clinical narrative: Approximately 20 minutes after vaccine was administered, patient developed a red spotted rash to neck and chest area and stated her tongue felt thick and felt very warm.  Patient was given 0.5mg Epi and 50 mg Benadryl IM @ 3:53 p.m. and 3:55 p.m.  EMS came, client declined transport.  Client taken to ER by her husband.
Age: 2.0
Sex: F
Vaccine: FLU3, HEPA, HIBV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Received call from mother 12/16/09 stating both legs very red at injection sites and sore.  Advised to see family physician or ER.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea
Clinical narrative: Patient returned shortly after receiving the shot complaining of dizziness and lightheadedness.  The patient was positioned on the floor with her legs elevated and given a cold compress.  Patient refused to have an ambulance called.  After approximately 10 minutes lying on the floor the patient elevated to a sitting position and complained of nausea as well.  Patient sat for another 5-10 minutes, and then wished to leave.  She was escorted by her father who was with her the entire time to his car.  The pharmacy technician also helped to escort the patient to the car.
Age: 4.0
Sex: F
Vaccine: DTAP, FLUN3, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Developed redness and swelling on two separate spots on right arm (around and tricep area) about 24 hrs after immunization given
Age: 59.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt states that she started feeling sore on her right upper arm since 12/28/09 at around 1500 then last night she noticed her arm is swollen. Noted swelling and redness to R upper arm. Advised to RTC if worse.
Age: 59.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient states that she started feeling sore on her right upper arm since 12/28/09 at around 1500 then last night she noticed that her arm is swollen noted swelling and redness to right upper arm.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain
Clinical narrative: 12-29-2009 can still feel where immunization was administered 9/29/09. Painful at site, numbness in L pinkie finger continuous-end of week pain began.
Age: 0.61
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV1
Symptoms: Computerised tomogram normal, Convulsion, Gaze palsy, Pyrexia
Clinical narrative: Mother said during the first overnight visit with dad pt's eyes rolled in the back of the head and pt. started seizing. Mother thinks it's due to pt. having a fever, however doesn't think that it is vaccine related. Mother thinks the event was hoax made up by the pt. father.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Confusional state, Cough, Diarrhoea, Laboratory test, Malaise
Clinical narrative: Son became very ill few days after receiving vaccination on 12-18-09. High fevers to 106.2, vomiting, diarrhea, coughing, aching body and confusion. Took to ER. Could not diagnose him with anything.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Son became very ill few days after receiving vaccination on 12-18-09. High fevers to 106.2, vomiting, diarrhea, coughing, aching body and confusion. Took to ER. Could not diagnose him with anything.
Age: 11.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Cold sweat, Dizziness, Pallor
Clinical narrative: Light headed, pale, clammy.
Age: 11.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Cold sweat, Dizziness, Pallor
Clinical narrative: Lightheaded, pale, clammy.
Age: 11.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Dizziness, Feeling hot, Hyperventilation, Paraesthesia
Clinical narrative: Hyperventilation, hot, dizzy, tingling on face.
Age: 15.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Feeling hot, Headache, Nausea
Clinical narrative: Hot, Headache, Nausea.
Age: 15.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Abdominal pain upper, Dizziness, Feeling of body temperature change, Headache
Clinical narrative: Headache, dizzy, stomach pain, hot and cold flashes
Age: 15.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Asthenopia, Dizziness, Headache
Clinical narrative: Headache, dizzy, heavy eyes.
Age: 15.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Fatigue, Headache
Clinical narrative: Headache, tired.
Age: 15.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Dizziness, Tremor
Clinical narrative: Dizzy, shakes.
Age: 16.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Chest pain, Muscular weakness
Clinical narrative: Chest pains, weak legs.
Age: 27.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Fatigue, Injection site pain, Lymphadenopathy
Clinical narrative: Swelling of glands, tenderness at site of inoculation and glands, and fatigue.
Age: 54.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Chest discomfort, Dysphagia, Oropharyngeal pain, Throat tightness
Clinical narrative: Soar throat, thraot constriction, difficuly (painful) swallowing; no effect on ability to breath, however.  Periodic tightness in chest; not severe.
Age: 17.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Erythema, Eye irritation, Ocular hyperaemia, Oral discomfort
Clinical narrative: complains of redness and burning around eyes and mouth. no swelling or difficulty breathing. pt told to monitor condition and call md immediately if getting worse
Age: 15.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Feeling hot, Nausea
Clinical narrative: Dizziness, hot, nausea
Age: 25.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Blood test, Chills, Erythema, Nausea
Clinical narrative: After receiving 2 vaccines in my left arm, I had nausea, fever, chills, and extreme pain in my arm. My arm was very red and swollen & I was weak.
Age: 25.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: After receiving 2 vaccines in my left arm, I had nausea, fever, chills, and extreme pain in my arm. My arm was very red and swollen & I was weak.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Convulsion, Electrocardiogram, Electroencephalogram, Nuclear magnetic resonance imaging
Clinical narrative: Patient had 3 seizures, 1 day after flu shot was administered, 1 at home, one at physician, 1 at hospital.    12/31/09:  Hospital records received for dates of service 10/14/09 to 10/16/09.  Dx:  New onset seizures.  Experienced eyes rolling to back of head, drooling, limbs went limp, lethargic but still breathing.  Tired and sleepy afterward for 5-10 minutes.  Repeated episode of seizure in peds. office, decision made to admit.  Admitted and experienced a third seizure on the same day, this time with tonic clonic activity. Oxygen desaturation to 60%, supplemental O2 given.  Started on fosphenytoin, and IV fluids.  Discharged home on Topamax.  01/04/10:  Primary care records and ED record received for dates of service 10/14/09 to 12/17/09.  No new information.
Age: 86.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Cough, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: 24 hours after receiving H1N1 vaccine, c/o fever, sore throat, general body aches, intermittent cough. Symptoms worsened on 12-28-09. Antibiotic therapy was started...Amoxicillin 500 mg TID x 10 days. 12-29-09 Follow up at clinic.
Age: 1.7
Sex: M
Vaccine: FLU(H1N1), FLU3, HEPA
Symptoms: Blood culture negative, Body temperature increased, Culture throat negative, Febrile convulsion, Full blood count
Clinical narrative: Pt had febrile sz at time vaccines administered on 12/16/09. Temp 101 degrees prior to sz & had gone up to 102 degrees immediately after sz. O2 via FM at 6C & TYLENOL PM. Sz at 2025, awake & in MOC's lap at 2100. Had febrile sz in office when seen for f/u 12/17/09 at 1820. Pt had had high temperature 102 when mom brought to office & she had not medicated. Child had O2 via FM & had has MORTRIN po prior to sz.
Age: 1.7
Sex: M
Vaccine: FLU(H1N1), FLU3, HEPA
Symptoms: Influenza serology negative, Respiratory syncytial virus test negative
Clinical narrative: Pt had febrile sz at time vaccines administered on 12/16/09. Temp 101 degrees prior to sz & had gone up to 102 degrees immediately after sz. O2 via FM at 6C & TYLENOL PM. Sz at 2025, awake & in MOC's lap at 2100. Had febrile sz in office when seen for f/u 12/17/09 at 1820. Pt had had high temperature 102 when mom brought to office & she had not medicated. Child had O2 via FM & had has MORTRIN po prior to sz.
Age: 16.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Headache, Dizzy, Nausea.
Age: 16.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Nausea
Clinical narrative: Shot-nausea.
Age: 15.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Hyperhidrosis, Nausea, Vertigo
Clinical narrative: Sweat, spinning, nausea.
Age: 15.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Dyspnoea
Clinical narrative: Hard to breathe.
Age: 16.0
Sex: M
Vaccine: FLUN3
Symptoms: Abdominal pain upper, Asthenia, Headache
Clinical narrative: Mist- Headache, feels weak, stomach cramps.
Age: 14.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Headache, Hot flush
Clinical narrative: Headache; lightheaded; hot flashes
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Burning sensation, Injection site pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: Scabbed for a month that was itchy. Felt burning sensation right below where vaccinated then moved to elbow to lower arm. Still hurts right below shoulder, very painful @ elbow. Still feel a burning sensation and shoulder hurts.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Scab
Clinical narrative: Scabbed for a month that was itchy. Felt burning sensation right below where vaccinated then moved to elbow to lower arm. Still hurts right below shoulder, very painful @ elbow. Still feel a burning sensation and shoulder hurts.
Age: 15.0
Sex: M
Vaccine: FLUN3
Symptoms: Asthenia, Muscle spasms
Clinical narrative: Cramps, weak.
Age: 17.0
Sex: F
Vaccine: FLUN3
Symptoms: Feeling hot, Throat tightness
Clinical narrative: Mist-"Hot" feeling in neck and arms, throat closing up but breathing OK.
Age: 17.0
Sex: F
Vaccine: FLUN3
Symptoms: Dizziness, Eye pruritus, Headache, Nausea
Clinical narrative: Mist-dizziness, headache, nausea, eyes itching.
Age: 16.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Burning sensation, Dizziness, Dysgeusia, Urticaria
Clinical narrative: Burning arm, metal taste in mouth, dizzy, hives.
Age: 16.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal pain upper, Asthenia, Dizziness
Clinical narrative: Mist-lightheaded, feeling weak, stomach cramps.
Age: 51.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Asthenia, Feeling abnormal, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Received the H1N1 vaccine on 12/23/2009 in the evening, began to feel a "surge" right away, he states that a surge is when he feels weak and the room "seems to fade away". He was walked out to the lobby to sit down, his blood pressure was taken and his temperature was taken. He was told he had a slight fever but no number was given to him. His temperature  was not taken  prior to receiving the vaccine. He was told to go home but he drove around his town for a few hours. He states he is allergic to thimerasol, SSRIS, he received teramycin as a child and vomited. He mentioned that he has felt a "surge feeling" after the past two seasonal flu shots but the effects went away quickly, this time after the H1N1 vaccine it lasted for 3 hours. He received the seasonal flu vaccine in September. The man stated he did not see his doctor for the surge feeling nor did he call him.
Age: 17.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Dizziness, Feeling hot, Nausea
Clinical narrative: Hot, Light headed, nausea.
Age: 18.0
Sex: M
Vaccine: UNK
Symptoms: Dizziness, Injection site warmth
Clinical narrative: Shot-hot and dizzy.
Age: 17.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Headache, Nausea, Tinnitus
Clinical narrative: Mist - Lightheaded, Dizziness, ears ringing, nausea headache.
Age: 16.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Headache, Nausea, Oropharyngeal pain
Clinical narrative: Mist - headache, nausea throat sore
Age: 15.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Dizziness, Sinus operation, Skin warm
Clinical narrative: Received mist-dizziness, feels warm, sinus drainage.
Age: 16.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Pain in right arm, numbness.
Age: 6.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Contraindication to vaccination
Clinical narrative: Received FluMist when it was marked asthma on his sheet. FluMist was also marked.
Age: 43.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Flushing, Headache, Pruritus
Clinical narrative: Noticed flushing, itching & headache. Pt going home, knows to call Dr if needed.
Age: 28.0
Sex: M
Vaccine: UNK
Symptoms: Cold sweat, Dizziness
Clinical narrative: Pt felt faint; cold sweat
Age: 14.0
Sex: F
Vaccine: FLU(H1N1), FLUN3
Symptoms: Urticaria
Clinical narrative: Hives outbreak on back, belly, upper arms and thighs (mild).
Age: 16.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt received NOVARTIS, 102138PTA .5 cc lm - (R) deltoid by above nurse. Pt has slight allergy to eggs. Pt eats eggs and gets a metalic taste, site is red, and swollen. (-) SOB, lung clear, pt observed 30 mins. Feels ok. Instructed to apply ice to site.
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Pain
Clinical narrative: MMR vaccine 8/21/09. 9/7 - Developed aching and throbbing pain in left Tricept with escalating intensity. 9/15 - Presented for evaluation negative swelling, negative bruising, negative tender thighs.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Anal abscess, Chorioamnionitis, Colposcopy, Drug exposure during pregnancy, Fungal infection
Clinical narrative: Information has been received from a nurse for the Pregnancy Registry for GARDASIL concerning a 21 year old female with no medical history or drug allergy who on 05-DEC-2008 was vaccinated with the second dose of GARDASIL (0947X). There was no concomitant medication. The patient's LMP was on 14-NOV-2008 and then the patient came into the clinic to receive the second dose of GARDASIL. Before the second dose of GARDASIL the patient was given a pregnancy test which came back negative and therefore the patient was given the second dose of GARDASIL. The patient came back into the clinic on 29-JAN 2009 and the patient found out she was pregnant. The nurse reported that the patient was approximately about a week to three weeks pregnant at the time she received the second dose of GARDASIL on 05-DEC-2008. No AE involved. The patient performed urine pregnancy test. The patient sought medical attention. Follow up information has been received from a registered nurse, concerning the patient with no illness at the time of vaccination or no pre-existing allergies or birth defects on 13-AUG-2008 received the first dose of GARDASIL and on 05-DEC-2008 AM received the second dose of GARDASIL IM on deltoid. The patient with 5 previous pregnancies had 1 full term delivery at 42 weeks from LMP, no pre-term delivery, 1 spontaneous abortions at 16 weeks from LMP, 3 elective terminations at unknown weeks from LMP and no fetal death. There was no birth defects in previous pregnancies. It was unknown if there any infant complications in previous pregnancies. Concomitant therapy included vitamins (unspecified). On 05-DEC-2008 the patient did a colposcopy pasts due for the second dose of GARDASIL. On 05-DEC-2008 pregnancy test was negative - specific gravity of urine was 1.025. The patient returned to office on 29-JAN-2009 and pregnancy test positive. On 23-MAR-2009 the patient did ultrasound for fetal structure scan and results indicated no abnormal findings. On 02-JUL-2009 the patient was treated with KEFLEX 500 mg 4 x/day for 7 days for infection and MONISTAT vaginal suppository x 7 days for yeast. And on 23-JUL-2009 the patient was treated with KEFLEX 500 mg 4 x/day for 7 days for infection. On 15-AUG-2009 the patient delivered a normal boy at 39 weeks from LMP. The boy weight 3628gm, length 15cm, Apgar score 8/9 and head circumference 33. The baby developed tachypnea and presumed sepsis. Course of IV antibiotics for 10 days, the baby was discharged on 25-AUG-2009. The patient developed perianal abscess/troakd during pregnancy. The patient developed severe chorioamnionitis, acute vasculitis and funisitis of umbilical cord during labor/delivery. All prenatal testing were normal during pregnancy. At the time of the report, the outcome of the patient was unknown. No further information is available. The baby's experience has been captured in WAES 0902USA02182B1.