chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV1
Symptoms: Dysgeusia, Grimacing, Regurgitation
Clinical narrative: This case was reported by a physician via a sales representative and described this occurrence of adverse taste in a child subject (baby) of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). In the first week of September 2008 the subject received 1st dose of ROTARIX (oral). At an unspecified time after vaccination with ROTARIX, the subject experienced adverse taste, grimaced and spit out the vaccine. At the time of reporting the outcome of the events was unspecified. The reporter mentioned that this event occurred in 5 or 6 babies that received ROTARIX.
Age: 0.2
Sex: F
Vaccine: DTAP, RV1, UNK
Symptoms: Diarrhoea, Incorrect route of drug administration, Pyrexia
Clinical narrative: This case was reported by a physician and described the occurrence of fever in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline), Diphtheria tetanus acellular pertussis). Concurrent vaccination included unspecified vaccine (manufacturer unspecified) given on 1 October 2008. On 1 October 2008 the subject received 1st dose of ROTARIX at 0.5 ml, intramuscularly and 1st dose of Diphtheria tetanus acellular pertussis. ROTARIX was administered via the wrong route. As indicated, ROTATRIX should be administered orally. Also, within 24 hours of vaccination with ROTARIX and diphtheria acellular pertussis, the subject experienced fever and diarrhea and was seen in the emergency room. At the time of reporting the outcome of the events was unresolved. In the physician's opinion, the events were possibly related to treatment with ROTARIX.
Sex: U
Vaccine: DTAP, HIBV, MMR, OPV, DTAP, HIBV, MMR, OPV
Symptoms: Body temperature increased, Deafness
Clinical narrative: A four-year-old previously healthy male patient received the following vaccines in April 1995: TRIPEDIA (lot number 4A51075), PEDVAXHIB (Merck, lot number 0716C), MMRII (Merck, lot number 1052A), and ORIMUNE (Lederle, lot number 0768A). Within two weeks of vaccination, the patient's mother noted a temperature of 100.6 and deterioration in hearing. An evaluation by an otorhinolaryngologist led to the diagnosis of hearing loss. No additional information was available. Follow-up information received on 14 March 2008 from a physician in the United States. Per the reporter, he was an author of the publication mentioned above and obtained the case information from VAERS database and other sources. He stated he had no additional information to provide for the patient described in the literature article. No further information is expected. Based on the available information no inference can be drawn regarding the cause of hearing loss.
Sex: U
Vaccine: DTAP, HIBV, MMR, OPV, DTAP, HIBV, MMR, OPV
Symptoms: Deafness, Pyrexia
Clinical narrative: A four-year-old previously healthy male patient received the following vaccines in April 1995: TRIPEDIA (lot number 4A51075), PEDVAXHIB (Merck, lot number 0716C), MMRII (Merck, lot number 1052A), and ORIMUNE (Lederle, lot number 0768A). Within two weeks of vaccination, the patient's mother noted a temperature of 100.6 and deterioration in hearing. An evaluation by an otorhinolaryngologist led to the diagnosis of hearing loss. No additional information was available. Follow-up information received on 14 March 2008 from a physician in the United States. Per the reporter, he was an author of the publication mentioned above and obtained the case information from VAERS database and other sources. He stated he had no additional information to provide for the patient described in the literature article. No further information is expected. Based on the available information no inference can be drawn regarding the cause of hearing loss.
Age: 11.0
Sex: F
Vaccine: DTAP, HPV4
Symptoms: Pallor, Syncope vasovagal, Unresponsive to stimuli, Vision blurred
Clinical narrative: This case was reported by a health professional on 04 October 2007.  An 11-year-old female patient with no reported history received an intramuscular right deltoid injection of TRIPEDIA (lot number U1813BA) and an intramuscular left deltoid injection of GARDASIL (Merck, lot number 10606) on 03 October 2007.  Within 15 minutes, the patient had blurred vision, and subsequently became pale and unresponsive.  She slid to the floor, and was responsive within one minute.  No respiratory distress was noted, and no EMS was required.  The patient recovered.  Additional information received 05 November 2007.  An 11-year-old female patient received TRIPEDIA (Per product insert, indicated through six years of age).  The reporter verified that the patient had not received any concomitant medications at the time of vaccination and had no prior history of fainting.  Diagnostic and laboratory testing had not been performed.  The reporter stated that this event was felt to be a vasovagal response.  No further information was provided.  Additional information received from a health car professional on 04 January 2008.  The reporter confirmed that the patient was 11-years-old and that the product administered with TRIPEDIA (TDAP was the intended vaccine).  17/Sep/2008: A corrective version with the same latest received date as the previous version (04/Jan/2008) was created to add the event of vasovagal response.
Age: 1.6
Sex: F
Vaccine: DTAP, HIBV, DTAP, HIBV
Symptoms: Oedema peripheral, Tenderness
Clinical narrative: A healthy 19-month-old female patient, had received on 31 July 2008 a fourth intramuscular injection of Tripedia, lot number U2397CA, combined with a third intramuscular injection of ActHIB lot number UP230AM (Sanofi Pasteur SA lot number A0547-2). The site of administration was not reported for either vaccine. Within six hours post-vaccination, the patient experienced "sudden increase in girth of thigh to 2 cm greater than other leg" with mild tenderness (site not provided). The event required physician evaluation, and no palpable mass noted. No diagnostic test or laboratory data were performed. At the time of this report, the patient had recovered, however, a recovery date was not provided. The reporter for this care is the same as for case 2008-02546.
Age: 1.6
Sex: F
Vaccine: DTAP, HIBV, DTAP, HIBV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: A healthy 19-month-old female patient, had received on 31 July 2008 a fourth intramuscular injection of Tripedia, lot number U2397CA, combined with a third intramuscular injection of ActHIB lot number UP230AM (Sanofi Pasteur SA lot number A0547-2). The site of administration was not reported for either vaccine. Within six hours post-vaccination, the patient experienced "sudden increase in girth of thigh to 2 cm greater than other leg" with mild tenderness (site not provided). The event required physician evaluation, and no palpable mass noted. No diagnostic test or laboratory data were performed. At the time of this report, the patient had recovered, however, a recovery date was not provided. The reporter for this care is the same as for case 2008-02546.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Computerised tomogram normal, Eye pain, Eye swelling, Headache, Herpes zoster
Clinical narrative: Patient receive Zostavax vaccine to prevent Shingles, ended up with Shingles, Bells Palsy and TIA all results of Zostavax
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Vomiting
Clinical narrative: Patient receive Zostavax vaccine to prevent Shingles, ended up with Shingles, Bells Palsy and TIA all results of Zostavax
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Facial palsy, Herpes zoster, Transient ischaemic attack
Clinical narrative: Patient receive Zostavax vaccine to prevent Shingles, ended up with Shingles, Bells Palsy and TIA all results of Zostavax
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, IPV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: No adverse events were noted; It was not noted until the patient arrived to receive her 4 month shots that it appears she had received 2 polio vaccinations with her 2 month vaccine series.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Headache, Lip swelling, Oedema peripheral, Pain
Clinical narrative: About 6 hours after receiving vaccine, pt states she had a headache and fever to 102.  Felt achy and fatigued the entire next day and also developed slight swelling of upper lip.  On day of presentation to clinic (2 days after receiving vaccine) pt developed itchy rash/slight swelling of both hands.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Rash pruritic
Clinical narrative: About 6 hours after receiving vaccine, pt states she had a headache and fever to 102.  Felt achy and fatigued the entire next day and also developed slight swelling of upper lip.  On day of presentation to clinic (2 days after receiving vaccine) pt developed itchy rash/slight swelling of both hands.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Death
Clinical narrative: Information has been received from a physician concerning a patient younger than 6 months who was vaccinated with a dose of oral ROTATEQ.  There was no concomitant medication.  Subsequently, the patient died after receiving a dose of ROTATEQ.  The cause of death has not been reported.  Unspecified medical attention was sought.  No product quality complaint involved.  Additional information has been requested. 10/30/08-records received for DOS 10/2-10/3/08-presented with fever 103 and lethargy, developed abdominal distention and occult blood positive stool. Decreased urine output. Exploratory laparotomy, drainage of peritoneal fluid, omentectomy, appendectomy.  Intubation and ventilation and resuscitation. Profound metabolic acidosis. Right pleural effusion. Necrotic omentum. Acute renal failure. 12/1/08-provisional autopsy report received-Provisional clinical diagnosis: suspected abdominal compartment syndrome. Emergency laparotomy with appendectomy, omentectomy and placement of peritoneal drain. Postoperatively developed severe thrombocytopenia and prolong APTT and INR. Hypotensive secondary to suspected ventricular fibrillation. Resuscitation unsuccessful. Pathologic examination of appendix revealed suppurative acute appendicitis with focal transmural necrosis and extensive periappendicitis.  4/6/09-final autopsy report received. Clinical Diagnosis:fever and lethargy. Abdominal distention and hem positive stool with currant jelly appearance. Acute passive hepatic congestion. Congestive splenomegaly. Bilateral renal medullary congestion. Hypotension due to suspected ventricular fibrillation. Postoperative severe thrombocytopenia and abnormal coagulation profile. krk
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Impaired work ability, Lacrimation increased, Muscular weakness
Clinical narrative: Information has been received from a registered nurse concerning a 34-year-old female who in 2007 was vaccinated with MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (Dose and route not specified). In 2007 the patient developed severe muscle weakness and had to quit her job. It was reported that the patient also developed eye tearing. She was advised by her physician never to get MMRII (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) again. The outcome of severe muscle weakness and eye tearing was unknown. No product quality complaint was involved. Upon internal review, severe muscle weakness was determined to be disabling. No further information is available.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Conjunctivitis allergic, Hypersensitivity
Clinical narrative: Flumist nasal vaccine administered.  Pt. had an allergic reaction - allergic conjunctivitis.  10/21/08 Reviewed PCP office notes of 8/13 & 9/26/08. FINAL DX: none provided Records reveal patient experienced fever, HA decreased appetite, irritability, runny nose, tonsils enlarged & red on 8/13.  Dx w/pharyngitis & HA.  When RTC on 9/26, was doing well when flumist given.  No further records available.
Age: 54.0
Sex: M
Vaccine: TDAP
Symptoms: Musculoskeletal pain
Clinical narrative: Experienced 2+ month history of shoulder pain described as sharp and deep in the shoulder.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Dehydration, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Patient came into clinic on 10/2 for flu shot and after getting home that evening began feeling flu-like and came back into emergency room with fever, chills and myalgias. Patient was re-hydrated with fluids and give PO TYLENOL.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Stomatitis, Vaccine positive rechallenge, Vaginal inflammation
Clinical narrative: Patient with stomatitis and vaginal mucositis beginning one week after each of her first two Gardasil injections.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Parent was notified by phone - waited in the office for 20 minutes. Pt was in for a  well child visit and father asked for flu shot. Nurse gave flu vaccine to the 2 months old patient. Pt waited in office for 20 minutes no noted reaction. Went back to notify patient, and they need left office.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Hyperhidrosis, Urticaria
Clinical narrative: 7 Hours after receiving vaccine patient developed chills, T101 , sweats and hives on both arms and head . Took benedryl, saw Medical Doctor  48hours later.
Age: 3.0
Sex: M
Vaccine: DTAP, FLU3, HEPA
Symptoms: Cellulitis
Clinical narrative: Right arm Cellulitis
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Cough, Feeling hot, Ocular hyperaemia
Clinical narrative: At 4 PM  Pt. came back to pharmacy said she was experiencing redness of eyes, burning sensation in nose, coughing, and hot feeling in face.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: 2 hours after flu-shot - left deltoid - c/o itching skin, no fever, no oral c/o.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Patient came in 24 hours later, area was puffy, redness the size of a 1/2 dollar.  Warm to the touch.  Tender around area.
Age: 1.3
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Varicella Disease
Age: 70.0
Sex: F
Vaccine: PPV, TD
Symptoms: Chills, Flushing, Injection site induration, Pain in extremity
Clinical narrative: Pneumovax given Friday - by evening, pt felt chilled, sore arm and hardness at site of injection.  Next day - Sat - patient felt flushed.  Pt reported this 10/8/08 at which time all symptoms were resolved.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Rash on face.  Vesicular, painless, bilateral.  Started 40 days after vaccine.  Examined on 10/13/08 and not resolved.
Age: 19.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Blood pressure normal, Dizziness, Heart rate normal, Nausea, Pallor
Clinical narrative: Pt became pale, light headed and nauseas after administration. Event reported to Provider - B/P and finger glucose obtained. After lying down for aprrox 5-10 mionutes, S/s disapeared and Pt stated that she felt fine. No treatment given
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Blister
Clinical narrative: was given influenza vaccine and developed 15mm multiple blisters to right deltoid. No treatment needed. No other signs or symptoms.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspepsia, Headache, Hypoaesthesia, Menstruation irregular, Urticaria
Clinical narrative: Developed numbness in arms, hands, feet and legs.  Headaches, irregular periods, heartburn, hives.  Began 2-3 months after first HPV vaccine administered.  Had brain MRI to look for MS with no lesions seen.  10/24/08 Office notes received from PCP. Parent reports continued numbness/tingling of feet/legs/hands, severe headaches and severe heartburn which began 2 months after 1st HPV shot. 12/1/2008 MR received from  neurologist. Referred from PCP for intermittent peripheral neuropathy in variable distribution. Pt presented with a several week hx of intermittant episodes of numbness of the feet, hands, and extremities. Neuro exam normal as pt was asymptomatic at time of exam. Impression:  Paresthesias. F/u reports 3/4/08 with continued numbness all over, interfering with pt's ability to run.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Anaemia, Menorrhagia
Clinical narrative: Menorrhagia (1 month duration of bleeding) with anemia
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Differential white blood cell count normal, Ecchymosis, Erythema, Full blood count normal, Oedema peripheral
Clinical narrative: Vigorous swelling, erythema, dependent ecchymosis involving entire left arm as well as upper back.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Body temperature increased, Cough, Heart rate increased, Palpitations
Clinical narrative: developed chest congestion, cough, elevated temp and heart rate, palpations.  antihistimine prescribed and send home from work.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Upper respiratory tract congestion
Clinical narrative: developed chest congestion, cough, elevated temp and heart rate, palpations.  antihistimine prescribed and send home from work.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Stomach discomfort, Vomiting
Clinical narrative: approx. 15 minutes after Flulaval administration, pt. began to vomit (three times in small amounts). no other signs/symptoms after vaccination. between time of vaccine admin. and adverse event, the pt. reported not eating breakfast and complained of stomach discomfort and decided to have a snack at the flu shot clinic.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Nausea, Pain, Pyrexia
Clinical narrative: HIGH FEVER (1O3 DEGREES); NAUSEA; VOMITING; CHILLS; ACHES; FATIGUE; SHAKING.  SYMPTOMS STARTED THE EVENING OF THE VACCINATION AND CONTINUED SEVERAL DAYS.  PATIENT IS STILL RUNNING FEVER (100.2) AND VOMITING 5 DAYS LATER ALTHOUGH SHE IS FEELING SOMEWHAT BETTER
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor, Vomiting
Clinical narrative: HIGH FEVER (1O3 DEGREES); NAUSEA; VOMITING; CHILLS; ACHES; FATIGUE; SHAKING.  SYMPTOMS STARTED THE EVENING OF THE VACCINATION AND CONTINUED SEVERAL DAYS.  PATIENT IS STILL RUNNING FEVER (100.2) AND VOMITING 5 DAYS LATER ALTHOUGH SHE IS FEELING SOMEWHAT BETTER
Age: 0.33
Sex: F
Vaccine: DTAP
Symptoms: Breath sounds abnormal, Dyspnoea, Irritability, Nasopharyngitis, Restlessness
Clinical narrative: Severe Cold, fluid in lungs, raspy breathing, irregular breathing, fussiness, restlessness. To this day, 2 weeks later, she is still restless and cranky.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster disseminated
Clinical narrative: Herpes Zoster onset 9/29/08, diagnosed 10/3/08 V1 distribution.  Disseminated zoster diagnosed 10/6/08 requiring hospitalization for IV acyclovir 10/6/08 to 10/9/08 at Hospital.  Recovered. 10/20/2008 MR received for DOS 10/6-9/2008 with D/C DX: Disseminated zoster.  Asthma.  Hx of HTN. Hx of tubular adenoma. Pt presented with Shingles rash already Dx'd for antiviral tx. Itchy rash is on L side of face, and scalp as well as multiple small eruptions on trunk and R arm. Mild h/a for last week. Ophth r/o ophthalmic involvement. Tx with Acyclovir.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Nausea
Clinical narrative: diarrhea and severe nausea
Age: 24.0
Sex: F
Vaccine: FLU3, HEP, HEPA, TYP
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: 09:08 received the following vaccines: HEPATITIS A MERCK 0020U 1.0CC IM RA, HEPATITIS B GSC AHBVB596CA 1.0CC IM LA, TYPHOID VI SANOFI A0923 0.5CC IM LA, FLULAVAL GSC AFFL197AA 0.5CC IM RA.  PT COMPLAINED OF DIZZINESS AND BLACKED OUT FOR APPX 15 SECONDS BEFORE BECOMING A+OX3.  PT GIVEN IV, BENADRYL AND PHENARGEN IN ACUTE CARE AREA AS A PRECAUTION.  NO FURTHER S/S.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: approx. 2 hours after receiving flu vaccine injection to left deltoid, arm very sore.Continued pain all evening, required vicodin. 18 hours after injection, entire arm sore. Fingers feel tingly and weak. Relates previous history of arm injury- unknown details.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Musculoskeletal stiffness, Pain
Clinical narrative: Patient states got flu shot on 10-4-08. Stated shot hurt when recieved, but not issues immediately following shot. Patient said about 14 hours later pain woke her up with stiffness on her right side. Patient said went all the way down her right side, including hand, hip, and knee. Patient denied any tingling associated with stiffness. Patient denies any other problem with the shot. Patient stated last a "couple of hours" and has no residual pain and/or stiffness today.
Age: 0.33
Sex: M
Vaccine: HIBV, PNC, TDAP
Symptoms: Wrong drug administered
Clinical narrative: PATIENT RECEIVED TDAP INJECTION INSTEAD OF PEDIAREX
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, raised and swollen at injection site and the red raised area is 3-4" in diameter and growing.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Rash macular, Urticaria
Clinical narrative: 10/14/08 8:00 AM  First noted hives on posterior aspect of both forearms and on anterior aspect of both thighs just above knees. At 3:00 PM hives are reduced to blotchy areas
Age: 20.0
Sex: M
Vaccine: ANTH, FLUN3, TYP, ANTH, FLUN3, SMALL, TYP
Symptoms: Rash papular
Clinical narrative: 30 SEP 08 VACCINATED. 14 OCT 08 PAPULES FORM ON ARMS AND SPREAD TO ARMS, TRUNK-FRONT AND BACK, BOTH LEGS. SEEN AT MEDICAL CENTER BY DR. ZYRTEC, BENADRYL, MOTRIN.
Age: 20.0
Sex: M
Vaccine: ANTH, FLUN3, TYP, ANTH, FLUN3, SMALL, TYP
Symptoms: Biopsy skin, Dermatitis, Rash generalised, Rash papular, Rash pruritic
Clinical narrative: 30 SEP 08 VACCINATED. 14 OCT 08 PAPULES FORM ON ARMS AND SPREAD TO ARMS, TRUNK-FRONT AND BACK, BOTH LEGS. SEEN AT MEDICAL CENTER BY DR. ZYRTEC, BENADRYL, MOTRIN.
Age: 20.0
Sex: M
Vaccine: ANTH, FLUN3, TYP, ANTH, FLUN3, SMALL, TYP
Symptoms: Vaccine positive rechallenge
Clinical narrative: 30 SEP 08 VACCINATED. 14 OCT 08 PAPULES FORM ON ARMS AND SPREAD TO ARMS, TRUNK-FRONT AND BACK, BOTH LEGS. SEEN AT MEDICAL CENTER BY DR. ZYRTEC, BENADRYL, MOTRIN.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Joint swelling, Urticaria
Clinical narrative: patient had Right sided joint swelling with hives
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Influenza, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: FLU LIKE SYNDROME, EXTREME PAIN AT INJECTION SITE, UNABLE TO MOVE ARM WITHOUT SEVERE PAIN.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Feeling cold, Tremor
Clinical narrative: Following vaccine administration, 1 week of intermittant shakiness, can't get warm, dizziness and lightheadedness.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Apnoea, Cyanosis
Clinical narrative: apnea 12 hours after pediarix, prevnar, oral rotavirus.  apnea and cyanotic x 2 requiring emergency transport and near intubation, perhaps pending intubation 10/16/08-records received for DOS 10/14/08-presented to ED with apnea times 30 seconds with spontaneous breathing. DX Apnea. ALTE.  Transferred to another facility.  10/27/08-records received for DOS 10/14-10/16/08-DC DX: Pneumonia.  Fever.
Age: 0.17
Sex: F
Vaccine: HIBV, PNC
Symptoms: Crying
Clinical narrative: inconsolable crying x 6 hrs - refused to lay on L  side - HIB vax given on L -
Age: 1.0
Sex: F
Vaccine: IPV, MMR
Symptoms: Pyrexia
Clinical narrative: HIGH fever, 105 onset one week after injection with MMR and Polio
Age: 21.0
Sex: M
Vaccine: FLUN3
Symptoms: Abdominal pain, Nausea, No reaction on previous exposure to drug
Clinical narrative: rlq colicky abd pain and nausea 20 minutes after administration of flumist, no previous problems with flu vax or any vax
Age: 81.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Patient developed a red, itchy rash on lower arms, upper leg and groin area and sides of abdomen.  He states his internist prescribed him a medrol dosepak and antibiotic and he he seems to be getting better.
Age: 23.0
Sex: F
Vaccine: FLUN3
Symptoms: No reaction on previous exposure to drug, Pruritus, Urticaria
Clinical narrative: Developed pruritis and wheals 10 minutes after flumist, mostly post neck and post ears, lungs clear, required IM benedryl, responded well, no sequelae. no previous hx of allergies or vax reactions
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy
Clinical narrative: Lymphadenopathy
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Heart rate increased, Hypotension
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of death-unknown cause in a 89-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included atrial fibrillation, cva and dementia. Concurrent medications included ATIVAN, PROZAC, LORTAB, PRILOSEC and CARAFATE. On 3 October 2008 at 17:15 the subject received a dose of FLULAVAL at 0.5 ml in the right arm. On 4 October 2008, approximately 21 hours after vaccination with FLULAVAL, the subject felt cool and clammy, had increased pulse and low blood pressure. Within 5 minutes, the subject experienced death-unknown cause. She was DNR (do not resuscitate). The healthcare professional considered the events were life threatening. The subject died on 4 October 2008, cause of death was not reported. It was unknown whether an autopsy was performed. 1/6/09-records received-Cause of Death-Sudden Cardiac Death. Cerebrovascular Disease. No autopsy performed.
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain lower, Abdominal pain upper, Anorexia, Arthralgia, Asthenia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of acute renal failure in a female subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). On 18 September 2008 the subject received 3rd dose of ENGERIX B at 0.5 ml in the left arm. On 02 October 2008, the subject began to complain of lower abdominal pain and was diagnosed with a hernia at a walk in clinic. On 06 October 2008, the subject continued to feel ill and was sent to the emergency room. From that day on, the subject has been hospitalized. The reporter also considered the events disabling, life threatening and clinically significant (or requiring intervention). Additional symptoms experienced by the subject included acute renal failure, stomach pain, platelets decreased, joint pain, lower abdominal pain, hernia, feeling unwell, headache, insomnia, diarrhea, vomiting, loss of appetite, weakness, chills, nausea, stomach cramps and petechiae. The subject was treated with blood transfusion. At the time of reporting the outcome of the events was unspecified.
Sex: F
Vaccine: HEP
Symptoms: Chills, Diarrhoea, Headache, Hernia, Insomnia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of acute renal failure in a female subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). On 18 September 2008 the subject received 3rd dose of ENGERIX B at 0.5 ml in the left arm. On 02 October 2008, the subject began to complain of lower abdominal pain and was diagnosed with a hernia at a walk in clinic. On 06 October 2008, the subject continued to feel ill and was sent to the emergency room. From that day on, the subject has been hospitalized. The reporter also considered the events disabling, life threatening and clinically significant (or requiring intervention). Additional symptoms experienced by the subject included acute renal failure, stomach pain, platelets decreased, joint pain, lower abdominal pain, hernia, feeling unwell, headache, insomnia, diarrhea, vomiting, loss of appetite, weakness, chills, nausea, stomach cramps and petechiae. The subject was treated with blood transfusion. At the time of reporting the outcome of the events was unspecified.
Sex: F
Vaccine: HEP
Symptoms: Malaise, Nausea, Petechiae, Platelet count decreased, Renal failure acute
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of acute renal failure in a female subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). On 18 September 2008 the subject received 3rd dose of ENGERIX B at 0.5 ml in the left arm. On 02 October 2008, the subject began to complain of lower abdominal pain and was diagnosed with a hernia at a walk in clinic. On 06 October 2008, the subject continued to feel ill and was sent to the emergency room. From that day on, the subject has been hospitalized. The reporter also considered the events disabling, life threatening and clinically significant (or requiring intervention). Additional symptoms experienced by the subject included acute renal failure, stomach pain, platelets decreased, joint pain, lower abdominal pain, hernia, feeling unwell, headache, insomnia, diarrhea, vomiting, loss of appetite, weakness, chills, nausea, stomach cramps and petechiae. The subject was treated with blood transfusion. At the time of reporting the outcome of the events was unspecified.
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of acute renal failure in a female subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). On 18 September 2008 the subject received 3rd dose of ENGERIX B at 0.5 ml in the left arm. On 02 October 2008, the subject began to complain of lower abdominal pain and was diagnosed with a hernia at a walk in clinic. On 06 October 2008, the subject continued to feel ill and was sent to the emergency room. From that day on, the subject has been hospitalized. The reporter also considered the events disabling, life threatening and clinically significant (or requiring intervention). Additional symptoms experienced by the subject included acute renal failure, stomach pain, platelets decreased, joint pain, lower abdominal pain, hernia, feeling unwell, headache, insomnia, diarrhea, vomiting, loss of appetite, weakness, chills, nausea, stomach cramps and petechiae. The subject was treated with blood transfusion. At the time of reporting the outcome of the events was unspecified.
Age: 11.0
Sex: M
Vaccine: FLUN3, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Left arm with red, circular area approximately 15cm x 13.5cm, warm to touch and tender after receiving Varivax.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Hyperhidrosis, Pyrexia
Clinical narrative: Sweating, Fever, and Headache left to go home.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Malaise, Tremor
Clinical narrative: violently ill temp 103  shaking chills now-malaise
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Eye pruritus, Headache, Throat tightness
Clinical narrative: Throat closing, eyes itchy, temp 102, headache.
Age: 38.0
Sex: M
Vaccine: FLUN3, SMALL
Symptoms: Dermatitis acneiform, Erythema
Clinical narrative: 10cm area of redness around area of the head/arms/back/chest/legs with eruption of acneoform pustules.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Blood culture negative, Full blood count normal, Headache, Nausea
Clinical narrative: High Fever, headache and back pain, nausea
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Urine analysis normal
Clinical narrative: High Fever, headache and back pain, nausea
Age: 83.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported extensive soreness and swelling throughout his upper right arm.  Above his right elbow he had a large bump.  His entire upper arm was warm to the touch.  He was advised to see a doctor ASAP.  Doctor at urgent care advised that it was an adverse reaction to the PNEUMOVAX.  He was advised to ice the area and keep it wrapped.  After follow-up with patient, he was reported full recovery.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Dime size  inducation on injection site, left deltoid.  Edema and redness to surrounding injection  site.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient received both PNEUMOVAX-23 and Influenza vaccine in her left arm, upper and lower deltoid (pt requested same arm). Pt reported redness and pain in upper arm in 24hrs. In 48hrs exam showed 20cm circular warm erythematous area in the (L) deltoid with minimal pain.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus
Clinical narrative: 4 hr after IM injection intense pruritus redness and edema developed 12x11cm (R) deltoid Tx with oral antihistamines and topical cortisone cream
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Cellulitis, Erythema, Fatigue, Malaise
Clinical narrative: Subject said she didn't fell well and was very tired after her vaccinations on 10/06/2008.  In the morning on 10/07/2008 she woke  us and her arm was painful, swollen, re and warm from her shoulder about 3 inches above her elbow of her right arm (the arm of the PNEUMOVAX vaccine).  She said she had temperature of about 101 degrees.  She saw a Dr  who put her on CEPHALEXIN 500mg, 1 cap tid for 1 week for cellulitis.  She had a follow up with her regular MD, on 10/10/08.  She stated that she had her first PNEUMOVAX in 2003 and Dr. wanted her to repeat it this year. RPh called her on 10/08/08 to discuss reaction and on 10/13/08 to follow up.  The patient stated that her condition had resolved.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Subject said she didn't fell well and was very tired after her vaccinations on 10/06/2008.  In the morning on 10/07/2008 she woke  us and her arm was painful, swollen, re and warm from her shoulder about 3 inches above her elbow of her right arm (the arm of the PNEUMOVAX vaccine).  She said she had temperature of about 101 degrees.  She saw a Dr  who put her on CEPHALEXIN 500mg, 1 cap tid for 1 week for cellulitis.  She had a follow up with her regular MD, on 10/10/08.  She stated that she had her first PNEUMOVAX in 2003 and Dr. wanted her to repeat it this year. RPh called her on 10/08/08 to discuss reaction and on 10/13/08 to follow up.  The patient stated that her condition had resolved.
Age: 36.0
Sex: M
Vaccine: MNQ
Symptoms: Asthenia, Chills, Impaired work ability, Nausea, Pain
Clinical narrative: Had vaccine 10/8/08 at 1:00 pm. Fever set in at 7 p.m. that evening. Ranged 101-102 deg- Nausea, vomiting, chills, body ache. His PCP told him to take Ibuprofen-(vomitted). Fever down by Saturday. Missed 2 days work. Today feeling okay, but lacks energy.
Age: 36.0
Sex: M
Vaccine: MNQ
Symptoms: Pyrexia, Vomiting
Clinical narrative: Had vaccine 10/8/08 at 1:00 pm. Fever set in at 7 p.m. that evening. Ranged 101-102 deg- Nausea, vomiting, chills, body ache. His PCP told him to take Ibuprofen-(vomitted). Fever down by Saturday. Missed 2 days work. Today feeling okay, but lacks energy.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Lymphadenopathy, Malaise, Oedema peripheral
Clinical narrative: 1 day past, Arm swelling and not felling well. 2nd day passed, arm swelling more and lymph nodes in neck swelling. Feeling sick, told to take benedryl.
Age: 1.9
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Some swelling and tenderness on left thigh
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Sensation of foreign body
Clinical narrative: pt returned to imz. table reporting trouble swallowing felt "something in throat". Pt had personal Epi Pen, this was administered at 350. BP were taken and documented, 911 was called and transported her
Age: 17.0
Sex: F
Vaccine: FLU3, HEPA, HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Pt. received two 0.5cc FLUZONE lot#U2811AA
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Back pain, Diet refusal, Full blood count, Headache, Neck pain
Clinical narrative: headache, bodyaches, neck and back pain, not eating
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Pain
Clinical narrative: headache, bodyaches, neck and back pain, not eating
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Nausea, Pain, Pain in extremity, Skin warm
Clinical narrative: Patient  c/o nausea and body aches, vomiting 1 1/2 hrs after shots given. Both arms sore with some redness and warm to touch. Patient  slept rest of that day and the next day s/s subsided  by the 3rd day without treatment .
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Somnolence, Vomiting
Clinical narrative: Patient  c/o nausea and body aches, vomiting 1 1/2 hrs after shots given. Both arms sore with some redness and warm to touch. Patient  slept rest of that day and the next day s/s subsided  by the 3rd day without treatment .
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Feeling abnormal, Neck pain, Tremor
Clinical narrative: Patient c/o shaking/chills, with associated neck pain x15min after receiving the flu vaccine. Occurred ~ 5 mins. after receiving vaccine. "Uneasy feeling" continued for several hrs. Symptoms resolved by next day.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Rash
Clinical narrative: Rash on abdomen right side, appears on (day4) after infection.
Age: 15.0
Sex: F
Vaccine: FLU3, HPV4, VARCEL
Symptoms: Burning sensation, Erythema, Pain, Pruritus, Skin warm
Clinical narrative: 10CM X 5cm Red area, burning, itching, warm and painful to touch for eight to ten hours. Benadryl given by mother for relief.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Lip swelling, Pain in extremity, Urticaria
Clinical narrative: Bedtime Friday 10PM 10/10 with sore arm. Woke up at midnight-1AM with swollen lips, whelps around groin area/armpits. Both upper arms, waist. 10/11 took BENADRYL 2 tabs (25 mg) and went back to bed. Up at 6:30AM , went for a walk stop to rest, hives had decreased with med q 4-6 hours. 10/13/08- body aches fever-none.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Chest pain
Clinical narrative: 10-10-08 Complained of chest pain, sharp, Midsternal after receiving vaccines ~ Approximately 10-15 min post vaccination was given Ibuprofen, 2 tabs. Pain seemed to lessen when recumbent. Status checks 2hrs later - patient. Felt better, still had slight pain.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Full blood count normal, Hypoaesthesia, Joint range of motion decreased, Pain, Paraesthesia
Clinical narrative: 10-10-08 patient called- reported  numb/tingle left thumb. Left arm throbbing. 10-13-08 office visit - pain left arm decreased range of motion in left shoulder
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperhidrosis, Oxygen supplementation, Pallor, Staring, Vomiting
Clinical narrative: Patient received (age 3) Flu vaccine, watched his sister get several vaccines and subsequently became diaphoretic, pastly, glassy eyed with episode of vomiting, No loss of consciousness. O2 by mask give, juice given. Color came back and after observation for about  30 - 4d days back to normal.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Drug exposure during pregnancy, Fatigue, Headache, Nausea, Pain
Clinical narrative: Patient is pregnant (14 weeks), Nausea, Fatigue and achiness. Began 3am 10/13/2008 and is ongoing . Patient also experiencing headaches. (Onset prior to vaccine)
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: Stiffing Pain with numbness and throbbing when lifting arm.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: 0.5 cc given to patient instead of 0.25 cc.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Full blood count, Injection site reaction, Local reaction, Rash generalised, Rash pruritic
Clinical narrative: Local reaction at site of injection - full body itchy Rash.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Streptococcal identification test
Clinical narrative: Local reaction at site of injection - full body itchy Rash.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Urticaria
Clinical narrative: Diffuse urticaria joint pain requiring treatment with oral steroids and antihistamines. Symptoms persisted x 4 days. Child seen in office twice and E.D. twice for worsening symptoms. Resolution of symptoms reported 10/12/08
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Culture, Dysstasia, Fatigue, Gait disturbance, Malaise
Clinical narrative: severe malaise, fatigue, muscle tenderness (generalised) difficulty with standing and walking without assistance.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Metabolic function test, Myalgia
Clinical narrative: severe malaise, fatigue, muscle tenderness (generalised) difficulty with standing and walking without assistance.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: redness, warmth, & swollen & hard from (R) elbow to (R) shoulder. (R arm only) treated with KEFLEX (from DR. visit) mother noted it started on FRI. (10/10/08) on Sun 10/12/08 the swelling and redness disappeared.
Age: 1.0
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Rash erythematous, Rash pruritic, Rash pustular
Clinical narrative: rash started yesterday 2-3 spots itches off and on no fever today 30 erythematous areas with small pustules
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Irritability, Oxygen saturation decreased, Pruritus, Urticaria
Clinical narrative: Within 5-10" of receiving DTaP/IPV/MMR/Varivax. Child became irritable, itchy and red on face and torso. Noted few small 1/4" raised areas (hives) on leg and torso. Refused BENADRYL. Has mouth tactile and aspiration issue. In next 1/2 hr. progressed to increased hives with O2 93%. Slight wheeze but not breathing difficulties. Improved after dissolving BENADRYL given.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Wheezing
Clinical narrative: Within 5-10" of receiving DTaP/IPV/MMR/Varivax. Child became irritable, itchy and red on face and torso. Noted few small 1/4" raised areas (hives) on leg and torso. Refused BENADRYL. Has mouth tactile and aspiration issue. In next 1/2 hr. progressed to increased hives with O2 93%. Slight wheeze but not breathing difficulties. Improved after dissolving BENADRYL given.
Age: 1.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Rash erythematous, Rash papular
Clinical narrative: 1 Year  Received Hepatitis A and Varicella in right thigh and developed redness, red bumps Approximately  10 days. Vaccine also has diffuse  Red Papular  rash
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Mother stated after patient received vaccines, both arms (that night) became itchy and very swollen - (Lasted for 3 days).  Induration formed.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, MMR, PNC, VARCEL
Symptoms: Conjunctivitis, Oedema peripheral, Pyrexia, Rash generalised, Rash macular
Clinical narrative: 2 yr old male, previously healthy, presented 4 days after receiving imms with 1 day Hx of fever up to 101.7, diffuse generalized fine macular rash all over the body more confluent on chest and back: with conjunctivitis, eye periorbital, hands & feet puffiness - likely exanthem from measles vaccine.  Dimetap PL2 as per 10-14-08, will recheck in 2 days.
Age: 42.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site induration
Clinical narrative: Induration at tetanus site of Right arm 5-10 mm. Resolved in 4 weeks.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Diarrhoea, Dizziness, Nausea
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 23 year old female with penicillin allergy who on 27-AUG-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (Lot # 660612/0229X), 0.5 mL, IM. There was no concomitant medication. On 27-AUG-2008, the patient experienced diarrhea, nausea and dizziness 60 to 90 minutes following vaccination. The patient's diarrhea and nausea and dizziness persisted. The patient sought medical attention by a phone call. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Asthenia, Nausea, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 11 year old female who on 03-SEP-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast), (route and administration site not reported). Concomitant therapy on the same day included MENACTRA and ADACEL. On the day of the vaccination the patient did have an upper respiratory infection with no fever. Within 24 hours the patient experienced a 102 F fever and dizziness. The patient sought medical attention via a phone call. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Dizziness, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 11 year old female who on 03-SEP-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast), (route and administration site not reported). Concomitant therapy on the same day included MENACTRA and ADACEL. On the day of the vaccination the patient did have an upper respiratory infection with no fever. Within 24 hours the patient experienced a 102 F fever and dizziness. The patient sought medical attention via a phone call. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site swelling, Pruritus
Clinical narrative: Information has been received from a nurse concerning a 17 year old female with exercised induced asthma and depression and a history of gastrooesophageal reflux disease who on 07-JAN-2008 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL vaccine (yeast) (lot # 654741/1208F). On 13-MAY-2008 the patient was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL vaccine (yeast) (lot # 659180/1758U). Concomitant therapy included hormonal contraceptives (unspecified), Albuterol and LEVSIN. On approximately 13-MAY-2008, after receiving her second dose, the patient developed round, red, raised, itchy bulls eye area on her arm, at the injection site. The area was raised in the center and on the outer edge. As of 08-SEP-2008, the patient's symptoms persisted. The patient sought unspecified medical attention via office visit. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 17 year old female with exercised induced asthma and depression and a history of gastrooesophageal reflux disease who on 07-JAN-2008 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL vaccine (yeast) (lot # 654741/1208F). On 13-MAY-2008 the patient was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL vaccine (yeast) (lot # 659180/1758U). Concomitant therapy included hormonal contraceptives (unspecified), Albuterol and LEVSIN. On approximately 13-MAY-2008, after receiving her second dose, the patient developed round, red, raised, itchy bulls eye area on her arm, at the injection site. The area was raised in the center and on the outer edge. As of 08-SEP-2008, the patient's symptoms persisted. The patient sought unspecified medical attention via office visit. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Syncope
Clinical narrative: Has syncopal episode with seizures, no previous medical hx of this. NO family hx of seizure, had last shot of GARDASIL 2/20/08.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Electroencephalogram abnormal, Syncope
Clinical narrative: Has syncopal episode with seizures, no previous medical hx of this. NO family hx of seizure, had last shot of GARDASIL 2/20/08.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Immediately After providing 1PV #4 Developed hive at the  injection site Approximately  1 1/2 cm - given 12.5 mg Benedryl and observed