chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: BENADRYL given to pt for now. Will f/u with new or worsening symptoms. -Red, itchiness, tender, warm on (L) thigh where vaccines were placed.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives on top lip, tongue itching.  Observed in office.  Administration of BENADRYL.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: was given MENACTRA 8/8/07 but was not noted in medical record. Pt seen 7/28/08 given MENACTRA again. No adverse event reported by patient or parents
Age: 5.0
Sex: M
Vaccine: HEPA, IPV, MMR, TDAP, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None.
Age: 7.0
Sex: F
Vaccine: HEPA
Symptoms: Eye swelling, Urticaria
Clinical narrative: Vaccine given Tuesday (07/22/08).  Father noticed hives, swollen eyes early Thurs. morning (07/24).  Given ZYRTEC & BENADRYL.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site pain, Pyrexia, Rash erythematous, Skin warm
Clinical narrative: 4 yo female with rash and fever 101.1 axillary at home since 09:00, in office 100.1. Patient also with pain along injection site. Rash erythematous, warmth on (L) thigh.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Body temperature increased
Clinical narrative: Mom states temp rectally was 101.7.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cellulitis, Local reaction
Clinical narrative: Local reaction that worsened & dx'd as cellulitis in ER.  Responded to antibiotics.  IPV was given at injection site.
Age: 6.0
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Local reaction
Clinical narrative: Severe local reaction to arm SQ inj sites with resulting cellulitis. (R) AND (L).
Age: 11.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Local reaction, Tenderness
Clinical narrative: (L) arm- tender reaction. (R) arm- tender reaction
Age: 50.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Chemotherapy, Death, Diplegia, Fall, Lung neoplasm malignant
Clinical narrative: Brother states patient developed "Transverse myelitis" from the MMR vaccine then the patient "Fell down and died". Developed paralysis in legs one week after shot. 8/11/08-records received for DOS 12/12/07-1/6/08- DX: Paraparesis secondary to transverse myelitis. Death secondary to pulmonary embolism. Admitted for evaluation of lower extremity weakness for 2-3 weeks, with shooting pain in feet on 12/14/07-balance difficulties noted, tingling in left upper extremity prior to hospitalization Upgoing plantar reflex noted on right side, lower extremity reflex loss at ankles and left patella.  Autopsy refused by family.
Age: 50.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Myelitis transverse
Clinical narrative: Brother states patient developed "Transverse myelitis" from the MMR vaccine then the patient "Fell down and died". Developed paralysis in legs one week after shot. 8/11/08-records received for DOS 12/12/07-1/6/08- DX: Paraparesis secondary to transverse myelitis. Death secondary to pulmonary embolism. Admitted for evaluation of lower extremity weakness for 2-3 weeks, with shooting pain in feet on 12/14/07-balance difficulties noted, tingling in left upper extremity prior to hospitalization Upgoing plantar reflex noted on right side, lower extremity reflex loss at ankles and left patella.  Autopsy refused by family.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Fatigue, Headache, Pyrexia, Tachycardia
Clinical narrative: Fever up to 103.9, Headache, fatigue, tachycardia (125) in office.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Patients mom called on 7/29/2008, and stated that the site where the injection was given ( RIGHT ARM) was red and swollen. I advised the patient and the mother to come in the office and have Dr. look at the area. Patient came into the office and saw Dr. Dr. documented in the chart, the following: Swelling, redness, warmth induration extending down from the injection site. Measured 7x10cm. No fever, no rash, No malaise, No LAD. To call back if it gets worse, LAD enlarged, fever greater than 101F, pain , redness increases, ect. Patinet will be called by myself this afternoon to see if the symptoms are getting better or worse.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Blood pressure decreased, Disorientation, Erythema, Fatigue, Loss of consciousness
Clinical narrative: Our daughter began throwing up in the school bathroom and passed out wihtin 90 minutes of receiving the vaccine.  They loaded her in a wheelchair and took her to the nurse's office.  She was pale, her skin was red and blotchy and her blood pressure had dropped significantly.  She was disoriented and extremely nauseous.  The immediate symptoms lasted for about 30 minutes with fatigue and naseua lasting for several hours.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Nausea, Pallor, Rash macular, Vomiting
Clinical narrative: Our daughter began throwing up in the school bathroom and passed out wihtin 90 minutes of receiving the vaccine.  They loaded her in a wheelchair and took her to the nurse's office.  She was pale, her skin was red and blotchy and her blood pressure had dropped significantly.  She was disoriented and extremely nauseous.  The immediate symptoms lasted for about 30 minutes with fatigue and naseua lasting for several hours.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Blood pressure decreased, Loss of consciousness, Vomiting
Clinical narrative: Our daughter began throwing up in the school bathroom and passed out wihtin 90 minutes of receiving the vaccine.  They loaded her in a wheelchair and took her to the nurse's office.  She was pale, her skin was red and blotchy and her blood pressure had dropped significantly.  She was disoriented and extremely nauseous.  The immediate symptoms lasted for about 30 minutes with fatigue and naseua lasting for several hours.
Age: 22.0
Sex: F
Vaccine: MMR, MNQ
Symptoms: Incorrect dose administered
Clinical narrative: Patient received pediatric dose of Hepatitis B. instead of adult dose.  Give Hepatitis B adult dose in 8 weeks.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Varicella
Clinical narrative: varicella  less than 50 lesions
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Body temperature increased, Crying, Drooling, Electroencephalogram normal, Full blood count normal
Clinical narrative: on 2/11/08(8 pm) had small spit-up and some drooling; face turn to the side and she was staring for about 1 minute; then she started to cry and she started to regain her face. A similar episode recurred at about 10 pm same night and also at 1 pm the following date. Temperature was 100.4 to 100.8  after the immunization. No jerky movements no rolling of eyes back; no cyanosis. She was addimeetd to the Hospital on 2/13/08 discharged 2/16/08  8/11/2008 MR received for DOS 2/13-16/2008 with D/C DX:  Sinusitis. Pt admitted after 3 episodes of staring following spitting up where the face was turned to the side and pt was pale and drooling. Pt had temp of 101.8'F following immunizations and had nasal congestion 2-3 days prior to vax. Tx with abc and d/c.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Infantile spitting up, Laboratory test normal, Lumbar puncture normal, Posture abnormal, Staring
Clinical narrative: on 2/11/08(8 pm) had small spit-up and some drooling; face turn to the side and she was staring for about 1 minute; then she started to cry and she started to regain her face. A similar episode recurred at about 10 pm same night and also at 1 pm the following date. Temperature was 100.4 to 100.8  after the immunization. No jerky movements no rolling of eyes back; no cyanosis. She was addimeetd to the Hospital on 2/13/08 discharged 2/16/08  8/11/2008 MR received for DOS 2/13-16/2008 with D/C DX:  Sinusitis. Pt admitted after 3 episodes of staring following spitting up where the face was turned to the side and pt was pale and drooling. Pt had temp of 101.8'F following immunizations and had nasal congestion 2-3 days prior to vax. Tx with abc and d/c.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Skin papilloma, Vaccine positive rechallenge
Clinical narrative: After second vaccine patient developed one wart on hand. It was treated and resolved. After third vaccine, patient broke out prolifically with warts across knuckles and fingers of both hands. Multiple treatments have not been successful.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: PATIENT DEVELOPED RASH AND AFTER SEEING HER PRIMARY CARE PHYSICIAN SHE WAS DIAGNOSED WITH SHINGLES.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Rash, Urethral caruncle, Urinary incontinence
Clinical narrative: PATIENT DEVELOPED RASH AND AFTER SEEING HER PRIMARY CARE PHYSICIAN SHE WAS DIAGNOSED WITH SHINGLES.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, VARCEL
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine given on 07/28/2008.  On 07/29/2008 temp of 102.  Treated with motrin.  Injection site red, swolen, hot to the touch & soreness.  On 07/30/2008 temp subsided.  Injection site still red, swolen, hot to the touch & soreness.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Body temperature increased, Febrile convulsion, Otitis media
Clinical narrative: Pt had febrile seizures with temps to 103F 7 days after MMR vaccination. Pt presented to outside ER. Patient received tylenol in ER, and discharged with amoxicillin for bilateral otitis media.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: urticaria.  RX benadryl prn
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Rash pruritic, Rash vesicular
Clinical narrative: developed aised red vesicular pruritic rash gen over upper thighs and arms. Recieved the vaccination on 7/23/2008 and rash developed on Thursday 7/24/2008.  Treated with zovirax, benadryl and topical hydrocortisone cream.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash papular, Rash pustular
Clinical narrative: Patient reports one week after vaccine administration he developed several papules and pustules on the lowere extremity with no clear cut etiology. He asked me to report it just in case it was a relevent reaction.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Croup infectious, Dysphonia, Dyspnoea, Hypoventilation, Tracheobronchitis
Clinical narrative: Patient developed difficulty breathing with short shallow breaths and hoarseness.  Parents proceded to take patient to ER for treatment.  Patient was treated for tracheobronchiolitis and croup.  Given Decadron orally and script for Orapred.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Aplastic anaemia, Contusion, Erythema, Fatigue, Night sweats
Clinical narrative: Tiredness, Night Sweats, Bruiseing, small red dots all over her body...they diagnosed her with having Aplastic Anemia.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Tiredness, Night Sweats, Bruiseing, small red dots all over her body...they diagnosed her with having Aplastic Anemia.
Age: 54.0
Sex: F
Vaccine: DTAP
Symptoms: Chills, Dizziness, Dyspnoea, Fatigue, Headache
Clinical narrative: WOKE UP SICK JUST BEFORE MIDNIGHT. SEVERE CHILLS, HEADACHE, NAUSEA, VOMITING, DIZZINESS, FEVER UP TO 102, BODY ACHES, TIREDNESS, DIFFICULTY BREATHING, FAST HEART BEAT, SLIGHTLY SWOLLEN LYMPH GLANDS.  SYMPTOMS LASTED 3 DAYS (SEVERE AT FIRST, PROGRESSIVELY EASING BY THIRD DAY).  HEADACHES KEPT RECURRING AND WERE EXTREMELY PAINFUL.  IBUPROFEN DIDN'T HELP.  MIGRAINE MEDS (IMITREX) EVENTUALLY HELPED.
Age: 54.0
Sex: F
Vaccine: DTAP
Symptoms: Heart rate increased, Lymphadenopathy, Nausea, Pain, Pyrexia
Clinical narrative: WOKE UP SICK JUST BEFORE MIDNIGHT. SEVERE CHILLS, HEADACHE, NAUSEA, VOMITING, DIZZINESS, FEVER UP TO 102, BODY ACHES, TIREDNESS, DIFFICULTY BREATHING, FAST HEART BEAT, SLIGHTLY SWOLLEN LYMPH GLANDS.  SYMPTOMS LASTED 3 DAYS (SEVERE AT FIRST, PROGRESSIVELY EASING BY THIRD DAY).  HEADACHES KEPT RECURRING AND WERE EXTREMELY PAINFUL.  IBUPROFEN DIDN'T HELP.  MIGRAINE MEDS (IMITREX) EVENTUALLY HELPED.
Age: 54.0
Sex: F
Vaccine: DTAP
Symptoms: Vomiting
Clinical narrative: WOKE UP SICK JUST BEFORE MIDNIGHT. SEVERE CHILLS, HEADACHE, NAUSEA, VOMITING, DIZZINESS, FEVER UP TO 102, BODY ACHES, TIREDNESS, DIFFICULTY BREATHING, FAST HEART BEAT, SLIGHTLY SWOLLEN LYMPH GLANDS.  SYMPTOMS LASTED 3 DAYS (SEVERE AT FIRST, PROGRESSIVELY EASING BY THIRD DAY).  HEADACHES KEPT RECURRING AND WERE EXTREMELY PAINFUL.  IBUPROFEN DIDN'T HELP.  MIGRAINE MEDS (IMITREX) EVENTUALLY HELPED.
Age: 26.0
Sex: F
Vaccine: RUB
Symptoms: Back pain, Injected limb mobility decreased, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Four days after I was given a Rubella vaccination my left shoulder began to have a severe pain, it spread to the middle of my back, neck, and down my arm. After a few days it was down my right arm and shoulder also. The pain was severe and I could hardly use my left arm at all. Nothing would help the pain. I tried a maximum dose of Ibuprophen, narcotic analgesics, ice, heat, arthritis "rub", hot showers, nothing even helped it at all. After about 3 weeks the pain finally subsided only to return every single time I exercise at anything more than a light effort. The pain is not as severe most of the time when it returns but it keeps coming back and can be severe at times. I have tried most over the counter drugs that are safe while breastfeeding (the vaccine was given to me immediately after giving birth) but none seem to work. I have gone to a chiropractor and that didn't work either.
Age: 2.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Asthenia, Pyrexia, Rash generalised
Clinical narrative: High fevers (103.5) for 5 days. Low energy, rash over body
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Haematochezia
Clinical narrative: On 5/29/08, child revieved his 2 months vaccines: Hep B #2, Prevnar #1 and Rotateq #1. Next day Mom noticed slight bright red blood in stool.  Doctor not notified. On 6/12/08 child recieved vaccine Hib #1, no adverse reaction.  On 7/29/08 child recieved vaccines Pediarix #2, Hib #2, Prevnar #2, and Rotateq #2.  Mom on 7/30/08 notifies doctor that childs bm had a small clump of bright red blood after 24 hours of getting vaccines.  Doctor reporting incident to be Hematochezia due to Rotateq vaccine.  Future Rotateq immunization will not be given for future dosing. No treatment was given, next bm was normal.
Age: 0.5
Sex: M
Vaccine: DTP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Body temperature increased, Lethargy, Somnolence
Clinical narrative: My son developed a temperature of 104. After receving his vaccinations my son was sleepy and lethargic for over four days.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Barium enema, Surgery
Clinical narrative: Patient was administered ROTATEQ on 4/1/08 and developed intussusception in 5/08 requiring surgical repair at hospital. 8/11/08-records received for DOS 5/26-63/08-DX: Intussusception. Presented to ED  crying, vomiting green colored emesis and blood in diaper. On 5/25/08 had bowel movement of mucus and blood. Stomach pain for past 2 days. Air reduction enema unsuccessful reduction of ileocolic intussusception. 8/26/08-records received-open reduction to reduce intussuception.
Age: 0.8
Sex: F
Vaccine: DTAP, PNC
Symptoms: Death
Clinical narrative: Pt deceased on 07/26/08. Currently case remains open at Medical Examiners office. Pt had no positive signs of illness at time of exam, normal PE.  10/20/2008 Autopsy received. COD Sudden Infant Death Syndrome. Infant found by parent cold and unresponsive. Resuscitation efforts were unsuccessful. No significant anatomic, circumstantial or toxicologic findings on Autopsy.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Abdominal X-ray, Carbon dioxide decreased, Intestinal obstruction, Intussusception, Leukocyturia
Clinical narrative: Patient had emesis x 5-7 episodes 4 days after ROTATEQ vaccination; diagnosed with obstruction due to INTUSSUSCEPTION; required surgery to relieve obstruction and removal of small segment of ascending colon.  08/27/2008 MR received for DOS 7/26-30/2008 with D/C DX:  Intussusception. Pt presented with several day hx of vomiting with dehydration. Pt had bloody stool during eval. PE (+) for depressed fontanelle and abdominal distention. Enema attempted for reduction which resulted in a bowel perforation. Pt taken for emergent exploratory lap with small bowel resection of perforated segment with primary anastomosis. Pt developed mild ileus post-op which resolved spontaneously and diet then advanced.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Surgery, Vomiting
Clinical narrative: Patient had emesis x 5-7 episodes 4 days after ROTATEQ vaccination; diagnosed with obstruction due to INTUSSUSCEPTION; required surgery to relieve obstruction and removal of small segment of ascending colon.  08/27/2008 MR received for DOS 7/26-30/2008 with D/C DX:  Intussusception. Pt presented with several day hx of vomiting with dehydration. Pt had bloody stool during eval. PE (+) for depressed fontanelle and abdominal distention. Enema attempted for reduction which resulted in a bowel perforation. Pt taken for emergent exploratory lap with small bowel resection of perforated segment with primary anastomosis. Pt developed mild ileus post-op which resolved spontaneously and diet then advanced.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site pain, Injection site swelling, Pain in extremity, Rash generalised, Urticaria
Clinical narrative: Pt got MENACTRA injection 071808, woke up 071908 with hives all over body and really sore arm at injection site. Went to clinic at University and was given steroid shot. Was unable to go to work 071908. As of 072008, hives were gone. As of 072508 still c/o soreness at injection site.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Diarrhoea, Gastrointestinal sounds abnormal, Irritability
Clinical narrative: Very fussy with lots of stomach noises for 4 hrs after 1st ROTATEQ.  Relieved by 1 episode of diarrhea.
Age: 24.0
Sex: F
Vaccine: HEP, TDAP, VARCEL
Symptoms: Erythema, Nodule, Skin warm
Clinical narrative: Possible reaction to VARIVAX.  Right arm red and warm to touch and knot on arm.
Age: 17.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: Cellulitis L arm (upper).  KEFLEX 500mg TID.
Age: 13.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Chicken pox vaccine notice yesterday on reaction - on 7/29/08 measures 30mmx30mm.  Red, swelling L deltoid SQ area.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Abdominal distension, Abdominal pain upper, Blood test normal, Dizziness, Headache
Clinical narrative: Pt. received GARDASIL dose #1, #2, & #3 - after #3 pt. experienced stomach pain, protruding stomach, trouble after eating.  Four times in the morning pt. walking to bathroom - lightheaded, fainted.  Frequent c/o HA, pain in muscle mostly R leg, hands trembling.  Pt. lost weight due to inability to eat because of pain.  ER visit -> bloodwork, check for ulcer, UA tests within normal limits.  Sxs continued.  Then went to regular Dr. - went to GI specialist/surgeon.  Scheduled upper & lower CAT scan of abd.  Test NL expect showed ovarian cysts.  Mom said news showed a story about a girl with similar symptoms.  "I'm 100% convinced it's from the shot" per mom.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Laboratory test normal, Myalgia, Oral intake reduced, Syncope, Tremor
Clinical narrative: Pt. received GARDASIL dose #1, #2, & #3 - after #3 pt. experienced stomach pain, protruding stomach, trouble after eating.  Four times in the morning pt. walking to bathroom - lightheaded, fainted.  Frequent c/o HA, pain in muscle mostly R leg, hands trembling.  Pt. lost weight due to inability to eat because of pain.  ER visit -> bloodwork, check for ulcer, UA tests within normal limits.  Sxs continued.  Then went to regular Dr. - went to GI specialist/surgeon.  Scheduled upper & lower CAT scan of abd.  Test NL expect showed ovarian cysts.  Mom said news showed a story about a girl with similar symptoms.  "I'm 100% convinced it's from the shot" per mom.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Urine analysis normal, Weight decreased
Clinical narrative: Pt. received GARDASIL dose #1, #2, & #3 - after #3 pt. experienced stomach pain, protruding stomach, trouble after eating.  Four times in the morning pt. walking to bathroom - lightheaded, fainted.  Frequent c/o HA, pain in muscle mostly R leg, hands trembling.  Pt. lost weight due to inability to eat because of pain.  ER visit -> bloodwork, check for ulcer, UA tests within normal limits.  Sxs continued.  Then went to regular Dr. - went to GI specialist/surgeon.  Scheduled upper & lower CAT scan of abd.  Test NL expect showed ovarian cysts.  Mom said news showed a story about a girl with similar symptoms.  "I'm 100% convinced it's from the shot" per mom.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Muscular weakness, Musculoskeletal pain, Pain in extremity, Weight bearing difficulty
Clinical narrative: 3 day after shot developed pain/weakness (L) arm/shoulder. c/o to able to lift self up into forklift due to weakness-treatment with aspirin/ VOLTAREN and called to f/u today-no better.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Disorientation, Dizziness, Hypoaesthesia, Musculoskeletal pain, Neck pain
Clinical narrative: Sharp, tingling pain in rt arm; shooting up through shoulder, neck, jaw, back of neck, and down arm to finger. Numbness in hand and finger. Lightheadeness and a little disoriented.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity, Pain in jaw, Paraesthesia
Clinical narrative: Sharp, tingling pain in rt arm; shooting up through shoulder, neck, jaw, back of neck, and down arm to finger. Numbness in hand and finger. Lightheadeness and a little disoriented.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: C/o hives that started 36 hours after receiving GARDASIL.  Pt also changed eye medication on that day from TOBRADEX ointment to TOBRADEX drops.  Has h/o hives frequently gets them with viruses, "these are worse".  Not ill.  Tried BENADRYL & CLARITIN which did not help.  Seen in office on 7/29/08 - for urticaria possible allergic rxn to GARDASIL or TOBRADEX drops.  Rx given for hydroxyzine 25mg one Q6 hours prn, may also try ZYRTEC, prn QD.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Borrelia burgdorferi serology negative, Electromyogram normal, Full blood count normal, Hypoaesthesia, Metabolic function test normal
Clinical narrative: Patient fainted after receiving GARDASIL #2.  Patient complained of tingling & numbness of both legs below the knees ~1 day after GARDASIL #2. 8/4/08-records received -7/2/07-C/O chronic shoulder pain. 4/9/08-C/O tingling in legs from knees down. Exercising with 16 pound weight loss, possible reduced potassium intake. 4/30/08-continues with C/O tingling in both legs. 6/25/08-neurology consult-C/O pins and needles in bilateral lower extremities. Swims and runs competitively. C/O developed in March 2008. PE WNL except for minimally decreased pinprick sensation in lateral aspect of both feet.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging normal, Paraesthesia, Syncope
Clinical narrative: Patient fainted after receiving GARDASIL #2.  Patient complained of tingling & numbness of both legs below the knees ~1 day after GARDASIL #2. 8/4/08-records received -7/2/07-C/O chronic shoulder pain. 4/9/08-C/O tingling in legs from knees down. Exercising with 16 pound weight loss, possible reduced potassium intake. 4/30/08-continues with C/O tingling in both legs. 6/25/08-neurology consult-C/O pins and needles in bilateral lower extremities. Swims and runs competitively. C/O developed in March 2008. PE WNL except for minimally decreased pinprick sensation in lateral aspect of both feet.
Age: 10.0
Sex: M
Vaccine: IPV, MMR, TD
Symptoms: Convulsion, Vomiting
Clinical narrative: Approx. 15 minutes after getting vaccines, child experienced seizure like symptoms with emesis x1.  After 5 minutes, in which vital signs were taken (stable), child was coherent x3.  Copy of vitals sent with ER persons that answered 911 call.  Child transported via ambulance to ER, released shortly.  Mom to sign ROI for ER report.  MD states "not time seizure".
Age: 8.0
Sex: F
Vaccine: HEP, TD
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Notice Td vaccine reaction on 7/28/08.  L deltoid apply ice packed.  Red induration swelling 4 inches x 4 inches.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral, Rash papular
Clinical narrative: Swollen right arm, no fever papulo rash erythema and 6cm diameter Rx Antihistamines
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Ice today, heat tomorrow.  Ibuprofen.  R leg swollen, red, warm to touch 3cm red, 8cm pink.
Age: 21.0
Sex: F
Vaccine: MMR, TD
Symptoms: Pyrexia, Rash, Rash macular
Clinical narrative: 0.5 cm or less macular scattered eruption on throat and neck. Fever.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site irritation, Injection site pruritus, Injection site swelling
Clinical narrative: reaction to (L) arm at site of Varicella injection given 7-28-08, complaint of burning, itching, sensation, redness, swelling noted, no pain, 3x2 inch area to (L) upper arm.
Age: 1.7
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Red, swollen, painful.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram head, Grand mal convulsion
Clinical narrative: Information has been received from a medical assistant concerning a 12 year old female with no pertinent medical history, drug reactions or allergies who in the morning of 23-JUL-2008 was vaccinated intramuscularly with a first dose of GARDASIL (Lot #63/0067X). In the afternoon of 23-JUL-2008, the patient was found by her sister on her bed having a seizure. The patient was taken to the emergency room. On the same day the patient recovered from seizure and was released from the emergency room. It was reported that vaccination with GARDASIL was discontinued. Follow-up information was received via telephone call on 28-JUL-2008 from the medical assistant. She did not know if the patient ate before or after the vaccination. She stated that the seizure occurred at night time. The patient went to the emergency room at a hospital. Diagnostic test and treatment from the hospital was not available. The patient was referred to a neurologist but there was no information from that appointment yet. The patient was suppose to return to the office after the neurology consult, but an appointment had not been scheduled. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested. 8/11/08-records received-presented to ED 7/24/08-C/O seizure like activity this evening, arms shaking and eyes rolling in back of head. Drowsy. DX: Seizure.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pregnancy test
Clinical narrative: Information has been received from a medical assistant concerning a 12 year old female with no pertinent medical history, drug reactions or allergies who in the morning of 23-JUL-2008 was vaccinated intramuscularly with a first dose of GARDASIL (Lot #63/0067X). In the afternoon of 23-JUL-2008, the patient was found by her sister on her bed having a seizure. The patient was taken to the emergency room. On the same day the patient recovered from seizure and was released from the emergency room. It was reported that vaccination with GARDASIL was discontinued. Follow-up information was received via telephone call on 28-JUL-2008 from the medical assistant. She did not know if the patient ate before or after the vaccination. She stated that the seizure occurred at night time. The patient went to the emergency room at a hospital. Diagnostic test and treatment from the hospital was not available. The patient was referred to a neurologist but there was no information from that appointment yet. The patient was suppose to return to the office after the neurology consult, but an appointment had not been scheduled. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested. 8/11/08-records received-presented to ED 7/24/08-C/O seizure like activity this evening, arms shaking and eyes rolling in back of head. Drowsy. DX: Seizure.
Age: 71.0
Sex: U
Vaccine: PPV, TTOX, PPV, PPV, TD
Symptoms: Autopsy, Death
Clinical narrative: Information has been received from a registered nurse concerning a 71 year old patient who on 21-JUL-2008 was vaccinated with PNEUMOVAX 23. There was no concomitant medication. The patient did not received any other vaccinations on the date. It was reported that the patient experienced an adverse event. On 22-JUL-2008 the patient died within 12 hours of being vaccinated. The patient's autopsy performed on 24-JUL-2008 but no results at the time of report. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Biopsy, Injection site discolouration, Rash
Clinical narrative: Rash appears on neck and few days after shot, cream then visit to dermatologist when rash spreads to chest and eventually down to legs - no itching - two doses Prednisone cream - 6 biopsies (nothing conclusive) (not allergic to egg or chicken).  Small brown spot around area where shot administered. 1/26/2010 Death  8/18/2008 MR received from dermatology consult dated 12/18/07 and 01/02/2008 with DX:  Contact dermatitis, possible drug eruption/allergy.  Pt presented with rash which began 2 days s/p flu shot.  PE (+) for erythematous annular and confluent patches on thighs, waistband and chest.  Erythematous cribiform patches of edematous papules on nape of neck. 31x3mm band of light brown macule on R upper arm at flu shit injection site. Rashes improve with steroids. ROS also (+) for SOB, night sweats, foot swelling, constipation and diarrhea. F/U 1/2/08 with rash slowing resolving.  8/25/2008 MR received for several OVs beginning 12/27/07 with DX:  Contact Dermatitis.  Erythema Multiforme.  Allergic urticaria.  Unspecified adverse effect of unspecified drug.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Abdominal pain, Differential white blood cell count normal, Nausea, Platelet count decreased, Vomiting
Clinical narrative: 7/23/08 Received MENACTRA , Hep A and ADACEL. That day developed N/V and abd pain. TO ED 7/23, 7/24 and 7/25. Admit 7/25-7/27/08 inpatient. CT abd (-), Blood cx (-), WBC ct 2.8 with NL diff and Platelets 90,000, no bleeding.8/12/08-records received for DOS 7/25-7/27/08-DC DX: Fever. Abdominal Pain. Mildly low white blood count. Thrombocytopenia. Seen in ED with C/O abdominal pain, vomiting on Fevers continued and returned to ED on 7/24 and 7/25/08.On 7/27/08 nose bleed. Left deltoid warm and tender at site of Adacel vaccine.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: White blood cell count decreased
Clinical narrative: 7/23/08 Received MENACTRA , Hep A and ADACEL. That day developed N/V and abd pain. TO ED 7/23, 7/24 and 7/25. Admit 7/25-7/27/08 inpatient. CT abd (-), Blood cx (-), WBC ct 2.8 with NL diff and Platelets 90,000, no bleeding.8/12/08-records received for DOS 7/25-7/27/08-DC DX: Fever. Abdominal Pain. Mildly low white blood count. Thrombocytopenia. Seen in ED with C/O abdominal pain, vomiting on Fevers continued and returned to ED on 7/24 and 7/25/08.On 7/27/08 nose bleed. Left deltoid warm and tender at site of Adacel vaccine.
Age: 0.6
Sex: F
Vaccine: DTAP, HIBV, RV5
Symptoms: Body temperature, Convulsion
Clinical narrative: Seizure 8/25/08-records received for DOS 7/7-7/9/08-DC DX: Seizure disorder secondary to vaccinations. Admitted via ED with history of seizure while in car seat, became stiff, pale and then lethargic. Postictal in ED.
Age: 38.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Cellulitis, Injection site swelling, Lymphadenopathy, Pain in extremity, Skin warm
Clinical narrative: Client reported arm hurt like a tetanus shot on 6/28. On 6/29, arm hurt worse, lymph nodes under arm were the size of a small apricot, couldn't place arm down close to side. On 6/29, arm felt hot to the touch, injection site was as large as her hand. Client was seen in an Urgent Care Center and diagnosed with cellulitis or a possible abscess. Client received IV antibiotic 6/29, two doses 6/30, and one dose 6/31; unable to determine name of medication. She also took doxycycline for 10 days. Client reported her arm cleared after treatment.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Death, Fatigue, Injection site pain, Viral infection
Clinical narrative: Information has been received from a physician concerning a 22 year old female who on an unspecified date was vaccinated with her third dose of GARDASIL. Subsequently the patient experienced soreness at the injection site and fatigue. The outcome of soreness at the injection site and fatigue was not reported. Two months after receiving her third dose of GARDASIL, the patient died. The cause of death was "viral insult to the heart". Unspecified medical attention was sought. Follow-up information was received via telephone call from the physician. The patient was a family member. She did not have the vaccination dates or lot numbers since she did not give them. The physician reported that the patient's mother thought that the patient died related to GARDASIL. She did not have the cause of death. The physician refused to provide patient information, information was gave to the coroner. The physician considered "viral insult to the heart" to be immediately life-threatening and disabling. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: Information has been received from a physician concerning his patient's daughter who on an unspecified date was vaccinated with a dose of GARDASIL. The patient's mother told to the physician that her daughter died in her dorm room 4 days after receiving the dose. The physician did not have much information because he did not administer the vaccine and the patient's daughter was not his patient. The reporter did not know the name of the physician who administered the vaccine. The physician considered the event to be life threatening. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Brain stem infarction, Dizziness, Left atrial dilatation, Left ventricular dysfunction, Nausea
Clinical narrative: Information has been received from a 73 year old male patient with diabetes and with no known drug reactions/allergies who on 16-JUN-2008 was vaccinated with a first dose of ZOSTAVAX (Oka/Merck) injecting in his arm. Concomitant therapy included WARFARIN, metoprolol, TRICOR and LIPITOR. On 16-JUN-2008, after receiving the ZOSTAVAX (Oka/Merck), the patient experienced extreme dizziness, nausea and vertigo on his way home. He did make it home, but one he got into the house he could not function due to the dizziness and he felt like he was going to vomit. The room was just spinning. He was kept hospitalized for 4 days. A magnetic resonance imaging (MRI), unspecified scans and blood work were performed but no result was provided. The patient's extreme dizziness and nausea and vertigo persisted. Additional information has been requested.8/18/08-records received for DOS 6/17-6/20/08-DC DX: Acute dizziness, possibly a cerebellar versus midbrain small infarct versus acute vestibular neuronitis. Presented to ED with C/O acute vertiginous attack, dizziness and diaphoresis.  Gait disturbance. 1/25/2010 Follow up: I have not felt real well since I took the vaccine, I now get more dizzy spells than before I took the vaccine.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Vertigo, Vestibular neuronitis
Clinical narrative: Information has been received from a 73 year old male patient with diabetes and with no known drug reactions/allergies who on 16-JUN-2008 was vaccinated with a first dose of ZOSTAVAX (Oka/Merck) injecting in his arm. Concomitant therapy included WARFARIN, metoprolol, TRICOR and LIPITOR. On 16-JUN-2008, after receiving the ZOSTAVAX (Oka/Merck), the patient experienced extreme dizziness, nausea and vertigo on his way home. He did make it home, but one he got into the house he could not function due to the dizziness and he felt like he was going to vomit. The room was just spinning. He was kept hospitalized for 4 days. A magnetic resonance imaging (MRI), unspecified scans and blood work were performed but no result was provided. The patient's extreme dizziness and nausea and vertigo persisted. Additional information has been requested.8/18/08-records received for DOS 6/17-6/20/08-DC DX: Acute dizziness, possibly a cerebellar versus midbrain small infarct versus acute vestibular neuronitis. Presented to ED with C/O acute vertiginous attack, dizziness and diaphoresis.  Gait disturbance. 1/25/2010 Follow up: I have not felt real well since I took the vaccine, I now get more dizzy spells than before I took the vaccine.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Abasia, Aphasia, Blood test, Computerised tomogram normal, Diplopia
Clinical narrative: Information has been received from a 73 year old male patient with diabetes and with no known drug reactions/allergies who on 16-JUN-2008 was vaccinated with a first dose of ZOSTAVAX (Oka/Merck) injecting in his arm. Concomitant therapy included WARFARIN, metoprolol, TRICOR and LIPITOR. On 16-JUN-2008, after receiving the ZOSTAVAX (Oka/Merck), the patient experienced extreme dizziness, nausea and vertigo on his way home. He did make it home, but one he got into the house he could not function due to the dizziness and he felt like he was going to vomit. The room was just spinning. He was kept hospitalized for 4 days. A magnetic resonance imaging (MRI), unspecified scans and blood work were performed but no result was provided. The patient's extreme dizziness and nausea and vertigo persisted. Additional information has been requested.8/18/08-records received for DOS 6/17-6/20/08-DC DX: Acute dizziness, possibly a cerebellar versus midbrain small infarct versus acute vestibular neuronitis. Presented to ED with C/O acute vertiginous attack, dizziness and diaphoresis.  Gait disturbance. 1/25/2010 Follow up: I have not felt real well since I took the vaccine, I now get more dizzy spells than before I took the vaccine.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Eye movement disorder, Hyperhidrosis, Nuclear magnetic resonance imaging normal, Vomiting
Clinical narrative: Information has been received from a 73 year old male patient with diabetes and with no known drug reactions/allergies who on 16-JUN-2008 was vaccinated with a first dose of ZOSTAVAX (Oka/Merck) injecting in his arm. Concomitant therapy included WARFARIN, metoprolol, TRICOR and LIPITOR. On 16-JUN-2008, after receiving the ZOSTAVAX (Oka/Merck), the patient experienced extreme dizziness, nausea and vertigo on his way home. He did make it home, but one he got into the house he could not function due to the dizziness and he felt like he was going to vomit. The room was just spinning. He was kept hospitalized for 4 days. A magnetic resonance imaging (MRI), unspecified scans and blood work were performed but no result was provided. The patient's extreme dizziness and nausea and vertigo persisted. Additional information has been requested.8/18/08-records received for DOS 6/17-6/20/08-DC DX: Acute dizziness, possibly a cerebellar versus midbrain small infarct versus acute vestibular neuronitis. Presented to ED with C/O acute vertiginous attack, dizziness and diaphoresis.  Gait disturbance. 1/25/2010 Follow up: I have not felt real well since I took the vaccine, I now get more dizzy spells than before I took the vaccine.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, RV5
Symptoms: Barium enema, Diarrhoea, Endotracheal intubation, Hydronephrosis, Intussusception
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 week old female with no medical history who on 17-MAR-2008 and 07-MAY-2008 was vaccinated PO with 2.0 ml of the first and second doses of ROTATEQ (first dose lot # 659852/1665U and second dose lot # 659774/0140X).  Concomitant vaccine therapy included on 17-MAR-2008 a dose of HEP B (lot #654436/1106F), IPOL, ACTHIB and PREVNAR.  No concomitant drug therapy reported.  On 19-APR-2008 the patient developed severe acute diarrhea and was hospitalized (19-APR-2008 - 25-APR-2008) for the treatment of urosepsis, septic shock.  The patient required intubation for correction of the septic shock.  The patient was diagnosed as having hydronephrosis by a renal ultrasound on approximately 19-APR-2008.  The patient recovered (date unspecified) after receiving unspecified treatment.  The NP felt that the diarrhea may have caused the urinary symptoms.  On 15-JUN-2008 the patient experienced intussusception and was hospitalized.  The patient recovered and was discharged on 17-JUN-2008.  On 30-JUN-2008 the patient experienced intussusception, the barium enema was negative for intussusception but the ultrasound was positive and the patient was hospitalized until 02-JUL-2008.  The NP reported that the third dose of ROTATEQ was held.  The patient fully recovered on an unspecified date.  The reporter considered the severe diarrhea, urosepsis, septic shock, hydronephrosis and both episodes of intussusception an other important medical event and immediately life-threatening.  Additional information has been requested. 8/13/08-records received for DOS 6/30-7/2/08-DC DX: Vomiting. Intussusception. Presented with coughing, vomiting and nonbloody diarrhea. Positive upper respiratory infections. Previously seen on 6/15/08 for self reduced intussusception times 2 and was negative on barium enema and E. coli pyelonephritis on 4/08.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, RV5
Symptoms: Septic shock, Ultrasound scan abnormal, Urosepsis
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 week old female with no medical history who on 17-MAR-2008 and 07-MAY-2008 was vaccinated PO with 2.0 ml of the first and second doses of ROTATEQ (first dose lot # 659852/1665U and second dose lot # 659774/0140X).  Concomitant vaccine therapy included on 17-MAR-2008 a dose of HEP B (lot #654436/1106F), IPOL, ACTHIB and PREVNAR.  No concomitant drug therapy reported.  On 19-APR-2008 the patient developed severe acute diarrhea and was hospitalized (19-APR-2008 - 25-APR-2008) for the treatment of urosepsis, septic shock.  The patient required intubation for correction of the septic shock.  The patient was diagnosed as having hydronephrosis by a renal ultrasound on approximately 19-APR-2008.  The patient recovered (date unspecified) after receiving unspecified treatment.  The NP felt that the diarrhea may have caused the urinary symptoms.  On 15-JUN-2008 the patient experienced intussusception and was hospitalized.  The patient recovered and was discharged on 17-JUN-2008.  On 30-JUN-2008 the patient experienced intussusception, the barium enema was negative for intussusception but the ultrasound was positive and the patient was hospitalized until 02-JUL-2008.  The NP reported that the third dose of ROTATEQ was held.  The patient fully recovered on an unspecified date.  The reporter considered the severe diarrhea, urosepsis, septic shock, hydronephrosis and both episodes of intussusception an other important medical event and immediately life-threatening.  Additional information has been requested. 8/13/08-records received for DOS 6/30-7/2/08-DC DX: Vomiting. Intussusception. Presented with coughing, vomiting and nonbloody diarrhea. Positive upper respiratory infections. Previously seen on 6/15/08 for self reduced intussusception times 2 and was negative on barium enema and E. coli pyelonephritis on 4/08.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Where T-dap was given - 19x16 cm area of erythema with mild swelling, nontender, no discharge, not indurated, mild increased warmth.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral, Rash
Clinical narrative: Rash on various parts of body right thumb swollen.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test
Clinical narrative: Information has been received from a registered nurse for the pregnancy registry for GARDASIL concerning an 18 year old female with a history of chickenpox disease at age 5 and no allergies who on 25-APR-2008 was vaccinated with the first dose of GARDASIL 0.5 ml IM. The patient at the time of vaccination of the first dose indicated she was not pregnant. On approximately 09-MAY-2008, the patient found out she was pregnant. The patient started at an unspecified date and went to the hospital. The hospital informed her on 01-JUN-2008 the patient had a miscarriage. On 25-JUL-2008 the patient was vaccinated with the second dose of GARDASIL 0.5 ml IM. The patient sought medical attention and told the nurse at an office visit. Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested
Sex: F
Vaccine: HPV4
Symptoms: Coma
Clinical narrative: Information has been received from a vaccine specialist and a nurse practitioner (N.P.) concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL. Subsequently, on an unspecified date following vaccination with GARDASIL, the patient fell into a coma. The outcome of the patient was not reported. Upon internal review, coma was determined to be an other important medical event. No further information is available.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Febrile convulsion, Pyrexia, Rash
Clinical narrative: Had febrile seizure, fever of 104 and rash 8 days after. went to ER
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 15 year old female who on an unspecified date was vaccinated intramuscularly with her third 0.5 ml dose of GARDASIL. Subsequently the patient experienced seizures. At the time of the report, the patient's seizures persisted. Unspecified medical attention was sought. Upon internal review, seizure was determined to be an other important medical event. This is one of several reports from the same source. Additional information has been requested.
Age: 1.7
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Erythema, Joint swelling, Oedema peripheral
Clinical narrative: Left thigh and knee red and swollen.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Dizziness, Immediate post-injection reaction, Tonic clonic movements, Unresponsive to stimuli
Clinical narrative: Information has been received from a physician concerning a 17 year old white female student with a history of syncope (February 2006), who after a check-up on 20-MAY-2008 was vaccinated with the first dose of GARDASIL (lot # 660387/1967U) into her left deltoid (route not reported). After vaccine was administered, the patient experienced dizziness then had a seizure with tonic movements. She was unresponsive 30-45 seconds then returned to baseline. After 10-15 minutes, the patient went to the waiting room. While talking to her, she stated "I can't hear you" and had another seizure lasting approximately 10-15 seconds. 911 was called. The patient was transferred to the emergency room (ER) via ambulance. She recovered and was referred to neurology. No testing was done in the ER. The patient was seen and discharged by the hospital's ER physician. Upon internal review, seizure with tonic movements and seizure were considered to be other important medical events. Additional information has been requested.