chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Contusion, Crying, Somnolence
Clinical narrative: 3 hrs after vaccinations patient seemed sleepy and when awoke for next feeding, cried inconsolably, no fever, both thighs were pink slight STS and slight bruise noted on right thigh.  Patient cried for 2 hours on and off then fell asleep, ate, then cried again.  2/5/08 doing well.
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Crying, Swelling, Tenderness
Clinical narrative: Unconsolable high pitched screams/cry 11:00AM-5:00PM day of vaccines.  Sore right upper thigh.  Tender to touch with multi swelling but no induration, no redness.
Age: 41.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: 7 cm. round raised erythematous eruption around injection site & 2 cm. rash at site.
Age: 30.0
Sex: M
Vaccine: SMALL
Symptoms: Fatigue, Immunisation reaction, Pain, Rash pustular, Scab
Clinical narrative: Pt received smallpox vaccine 1/16/08. Returned 1/23/08 with major reaction, on 1/25 noted pustules forming arms, neck, lip and back seen in office 1/28. Body aches, fatigue. Diag: generalized vaccine reaction. Plan Levaquin 750mg PO Qd #5, Reevaluated 2/4/08 pustules scabbed over - SX resolved (pics taken).
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Erythema
Clinical narrative: Saturday 2/2/08 started with red bumps on belly.  Bumps are spreading.  Last Friday had fever.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Erythema, Pain, Swelling, Urticaria
Clinical narrative: Orange size circle, raised and red, painful.  No fever, positive welting.
Age: 53.0
Sex: F
Vaccine: PNC
Symptoms: Wrong drug administered
Clinical narrative: Pediatric pneumococcal conjugate given instead of adult. No adverse event.
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Ear pain, Pain in extremity, Pharyngolaryngeal pain, Postnasal drip, Productive cough
Clinical narrative: Description: I received AVA # 2 12 days ago and had some arm soreness and a low grade fever. What I am concerned about is that within 24 hrs I developed a cough with phlegm and felt like I was catching a cold. this went away and then returned. No fever now but cough and congestion continues. No body pains, but reports sore throat, sinus pressure, post nasal drip, slight stuffy nose and some ear pressure. he is new to the area and has had childhood allergies to dust and certain pollen. Grew in another state. Other than soreness no problem with AVA # 1. Wondering if AVA is causing his problems. Symptom: Cough, productive Start: 01/24/2008; Symptom: fever start: 01/24/2008; Symptom: Nasal Drainage Start: 01/24/2008; Symptom: Ear Pain Start: 01/24/2008; Symptom: Pain Start: 01/24/2008 Comment: throat pain/sore throat.
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Pyrexia, Respiratory tract congestion, Sinus headache
Clinical narrative: Description: I received AVA # 2 12 days ago and had some arm soreness and a low grade fever. What I am concerned about is that within 24 hrs I developed a cough with phlegm and felt like I was catching a cold. this went away and then returned. No fever now but cough and congestion continues. No body pains, but reports sore throat, sinus pressure, post nasal drip, slight stuffy nose and some ear pressure. he is new to the area and has had childhood allergies to dust and certain pollen. Grew in another state. Other than soreness no problem with AVA # 1. Wondering if AVA is causing his problems. Symptom: Cough, productive Start: 01/24/2008; Symptom: fever start: 01/24/2008; Symptom: Nasal Drainage Start: 01/24/2008; Symptom: Ear Pain Start: 01/24/2008; Symptom: Pain Start: 01/24/2008 Comment: throat pain/sore throat.
Age: 1.3
Sex: M
Vaccine: HEPA, MMR, VARZOS
Symptoms: Rash
Clinical narrative: Developed rash after receiving immunizations.  Possible post vaccination VZ vs. step rash.  Treated with Duricef 200mg twice daily for 5 days and Benadryl.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site nodule, Injection site warmth
Clinical narrative: Bump at site of chicken pox vaccine, warm to touch, non tender.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Feeling hot
Clinical narrative: Within 24 hours positive erythema from insertion down to elbow - warm to touch, hardened area 2cm x 2cm.  Lasted 3 days.
Age: 38.0
Sex: M
Vaccine: HEP
Symptoms: Facial palsy, Hypoaesthesia oral, Neck pain
Clinical narrative: Severe pain neck under occipital bone and left Trapezoid 8 hours after shot. 3 days in numbness to left side of mouth and tongue, 5 days in numbness radiating up to left eye. Diagnosis Bells' Palsy and prescribed Prednisone and acyclovir (Valtrex) (Vaccine shot given 01/08/08)
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion
Clinical narrative: We received on 24 JAN 2008 from a healthcare professional the following information: A 71-year-old female patient, born on 16 SEP 1936, was vaccinated i.m. with Fluvirin (batch no. unknown) on 09 OCT 2007. The patient experienced severe bruising on the extremities. It was reported that the patient experienced idiopathic thrombocytopenic purpura the last 2 years after vaccination (see cases MA2008-0090 and MA2008-0091). The outcome is unknown.
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Idiopathic thrombocytopenic purpura, Vaccine positive rechallenge
Clinical narrative: We received on 24 JAN 2008 from a healthcare professional the following information: A female patient, born on 16 SEP 1936, was vaccinated one year ago with an influenza virus vaccine (batch no. and manufacturer unknown) on an unknown date. The reporter believes that it was Fluvirin. The patient experienced idiopathic thrombocytopenia purpura. The outcome is unknown. She had a full workup by a hematologist with inconclusive results as to cause of ITP. It was reported that the patient also experienced idiopathic thrombocytopenic purpura 2 years ago after a flu vaccine (see case MA2008-0090) and severe bruising after this year's vaccination (MA2008-0092).
Sex: F
Vaccine: FLU3
Symptoms: Idiopathic thrombocytopenic purpura
Clinical narrative: We received on 24 JAN 2008 from a healthcare professional the following information: A female patient, born on 16 SEP 1936, was vaccinated, two years ago with an influenza virus vaccine (batch no. and manufacturer unknown) on an unknown date. The patient experienced idiopathic thrombocytopenic purpura. The outcome is unknown. It was also reported, that she experienced adverse events in the following two years (see cases MA2008-0091 and MA2008-0092).
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Asthenia, Balance disorder, Candidiasis, Cognitive disorder
Clinical narrative: RECEIVED ANTHRAX VACCINATIONS 1/2000. SEE PREVIOUS VAERS REPORTS FOR SAME INCIDENT. NOW, EIGHT YEARS LATER, I AM STILL ILL. I SUFFER FROM SEVERE COGNITIVE PROBLEMS: (MEMORY, THINKING, ANALYZING, TECHNICAL ABILITY IS GONE...ETC..), MUSCLE + JOINT PAIN AND SPASM, EASILY PULL MUSCLE AND/OR CRAMP, UNREFRESHING SLEEP, CHRONIC FATIGUE, NO STAMINA OR STRENGTH, DIZZINESS + UNBALANCED, MOTION SICKNESS, EASILY DEHYDRATED, RINGING IN THE EARS, IRRITABLE BOWEL SYNDROME, CANDIDA SYNDROME, MILD DEPRESSION (FROM DEALING WITH ALL THIS). NOT SUICIDAL BUT VERY FRUSTRATED AND SOMETIMES CLOSE TO LOSING IT.
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Dehydration, Depression, Diagnostic procedure, Dizziness, Fatigue
Clinical narrative: RECEIVED ANTHRAX VACCINATIONS 1/2000. SEE PREVIOUS VAERS REPORTS FOR SAME INCIDENT. NOW, EIGHT YEARS LATER, I AM STILL ILL. I SUFFER FROM SEVERE COGNITIVE PROBLEMS: (MEMORY, THINKING, ANALYZING, TECHNICAL ABILITY IS GONE...ETC..), MUSCLE + JOINT PAIN AND SPASM, EASILY PULL MUSCLE AND/OR CRAMP, UNREFRESHING SLEEP, CHRONIC FATIGUE, NO STAMINA OR STRENGTH, DIZZINESS + UNBALANCED, MOTION SICKNESS, EASILY DEHYDRATED, RINGING IN THE EARS, IRRITABLE BOWEL SYNDROME, CANDIDA SYNDROME, MILD DEPRESSION (FROM DEALING WITH ALL THIS). NOT SUICIDAL BUT VERY FRUSTRATED AND SOMETIMES CLOSE TO LOSING IT.
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Fibromyalgia, Frustration, Inner ear disorder, Irritable bowel syndrome, Malaise
Clinical narrative: RECEIVED ANTHRAX VACCINATIONS 1/2000. SEE PREVIOUS VAERS REPORTS FOR SAME INCIDENT. NOW, EIGHT YEARS LATER, I AM STILL ILL. I SUFFER FROM SEVERE COGNITIVE PROBLEMS: (MEMORY, THINKING, ANALYZING, TECHNICAL ABILITY IS GONE...ETC..), MUSCLE + JOINT PAIN AND SPASM, EASILY PULL MUSCLE AND/OR CRAMP, UNREFRESHING SLEEP, CHRONIC FATIGUE, NO STAMINA OR STRENGTH, DIZZINESS + UNBALANCED, MOTION SICKNESS, EASILY DEHYDRATED, RINGING IN THE EARS, IRRITABLE BOWEL SYNDROME, CANDIDA SYNDROME, MILD DEPRESSION (FROM DEALING WITH ALL THIS). NOT SUICIDAL BUT VERY FRUSTRATED AND SOMETIMES CLOSE TO LOSING IT.
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Memory impairment, Motion sickness, Muscle spasms, Myalgia, Sleep disorder
Clinical narrative: RECEIVED ANTHRAX VACCINATIONS 1/2000. SEE PREVIOUS VAERS REPORTS FOR SAME INCIDENT. NOW, EIGHT YEARS LATER, I AM STILL ILL. I SUFFER FROM SEVERE COGNITIVE PROBLEMS: (MEMORY, THINKING, ANALYZING, TECHNICAL ABILITY IS GONE...ETC..), MUSCLE + JOINT PAIN AND SPASM, EASILY PULL MUSCLE AND/OR CRAMP, UNREFRESHING SLEEP, CHRONIC FATIGUE, NO STAMINA OR STRENGTH, DIZZINESS + UNBALANCED, MOTION SICKNESS, EASILY DEHYDRATED, RINGING IN THE EARS, IRRITABLE BOWEL SYNDROME, CANDIDA SYNDROME, MILD DEPRESSION (FROM DEALING WITH ALL THIS). NOT SUICIDAL BUT VERY FRUSTRATED AND SOMETIMES CLOSE TO LOSING IT.
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Thinking abnormal, Tinnitus
Clinical narrative: RECEIVED ANTHRAX VACCINATIONS 1/2000. SEE PREVIOUS VAERS REPORTS FOR SAME INCIDENT. NOW, EIGHT YEARS LATER, I AM STILL ILL. I SUFFER FROM SEVERE COGNITIVE PROBLEMS: (MEMORY, THINKING, ANALYZING, TECHNICAL ABILITY IS GONE...ETC..), MUSCLE + JOINT PAIN AND SPASM, EASILY PULL MUSCLE AND/OR CRAMP, UNREFRESHING SLEEP, CHRONIC FATIGUE, NO STAMINA OR STRENGTH, DIZZINESS + UNBALANCED, MOTION SICKNESS, EASILY DEHYDRATED, RINGING IN THE EARS, IRRITABLE BOWEL SYNDROME, CANDIDA SYNDROME, MILD DEPRESSION (FROM DEALING WITH ALL THIS). NOT SUICIDAL BUT VERY FRUSTRATED AND SOMETIMES CLOSE TO LOSING IT.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL, HEPA, MMR, PNC, VARCEL
Symptoms: Blister, Injection site vesicles
Clinical narrative: Blisters where vaccine was administered, slight fever.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL, HEPA, MMR, PNC, VARCEL
Symptoms: Injection site vesicles, Pyrexia
Clinical narrative: Blisters where vaccine was administered, slight fever.
Age: 31.0
Sex: F
Vaccine: ANTH
Symptoms: Pruritus, Rash macular, Rash pustular
Clinical narrative: Pustular red itchy macules on feet and ankles.
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Blister, Rash, Rash erythematous, Rash maculo-papular
Clinical narrative: 24 yo male complained of rash on legs x 2 days.  Received smallpox vaccination 16 days prior.  Skin with erythematous rash vesicles, maculopapular bilateral LE most below kneew, L arm some just below inoculation site, few on abdomen and R arm. Temp 98.6, PE = VSS, Lungs CTAB, Heart RRR, Abd Soft NtND.  Hydroxyzine 25mg, 2PO q 6hrs prn itching, increased to 100mg po q 6hrs.
Age: 20.0
Sex: M
Vaccine: ANTH, FLU3, SMALL
Symptoms: Culture, Erythema, Rash
Clinical narrative: Pt. began to see red bumps on his chest in a V-shape about 10 days after vaccination.  Member reported to clinic on day 11 with bumps on his back and arms as well.  No discharge, fever, or itching.  Reaction prevented member from deploying the next day.
Age: 17.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pustule, Injection site warmth
Clinical narrative: 1/29/08 Received phone call from patients father. Patient c/o right arm being sore from where Menactra was administered. Father noted area to be tender, slightly red, warm to touch and appears has a pustule type area in the center. I advised to use warm compresses, and contact physician. Apparently the area had been somewhat tender since administration, but patient had not informed a family member. 1/31/08 Spoke with father. Patient used warm compresses for a very short time. Did not contact physician as of yet. 2/6/08 Contacted by father.  Father contacted family physician's office. They issued patient a script for a 10 day supply of a sulfa based antibiotic on Friday 2/1/08. The spot on her right arm is smaller and is now cool to the touch.  "It looks like it is clearing up" per father's statement.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Dizziness, Presyncope
Clinical narrative: The day of Vaccine everything was fine. The next day my daughter was dizzy and felt very weak. She nearly fainted twice. The weakness subsided after two days but she continued to feel dizzy for a total of five/six days. The last few days she described that if she looked up of down and then went to focus on something she still felt dizzy. She has not complained of this for the last three days. It was very worrisome. And, it felt like there was no one to turn too.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Local reaction, Oedema peripheral, Rash, Skin warm
Clinical narrative: Had localized reaction with rash, heat, swelling.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Pain in extremity, Paraesthesia, Pruritus, Tenderness
Clinical narrative: Patient called on 2/4/08 at 9am and spoke to writer regarding a flu vaccination she received on 11/06/07.  She informed writer she was currently having tingling and pain radiating up her R arm which was now proceeding down towards her right elbow.  She stated her symptoms began not long after receiving her flu vaccination in November with some localized tenderness and itching. She also reported having a black and blue mark at the injection site which has not gone away. She states her symptoms have become progressively worse with increased pain, and tingling.  She stated she has not reported nor seen her primary care physician regarding her signs and symptoms.  Writer recommended she call her primary care physicain for treatment and follow-up. Patient agreed to call her primary care physican and will follow up with writer after this assessment is completed.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Immune system disorder
Clinical narrative: Pt states he believes his immune system has been affected by anthrax immunizations since 1996.  "Use to get only one cold a year, now I am getting 6 or 7 per year."  Pt has not previously presented to clinic of any of these "colds" and states they did not affect his active duty flying status.  Pt is wanting this subjective effect to be documented.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Dyskinesia, High-pitched crying, Staring
Clinical narrative: 02/04/08 received vaccines @ 0930A. At 0730P started crying, high pitched. Child couldn't be consoled. Around 0830P child had staring event followed by mild jerking, lasting approx 1 minute. Called Dr. on 2/5/08, not seen was told to monitor child.
Age: 0.76
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Vaccine administered before 12 months of age.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Erythema, Gait disturbance, Oedema peripheral, Skin warm
Clinical narrative: Right Leg where Varivax immunization administered was red, swollen and warm.  Size was 2-3 inches in diameter.  Patient had difficulty walking.
Age: 32.0
Sex: F
Vaccine: ANTH
Symptoms: Chills, Night sweats, Pyrexia
Clinical narrative: High fever after receiving does #3 of anthrax vaccination...104.5 and chills with night sweats for 2 days.
Age: 32.0
Sex: F
Vaccine: ANTH
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site warmth, Lymphadenopathy
Clinical narrative: High Fever 105....chills, lymph nodes in left armpit swelled up...cramps throughout body...arches of feet to neck.  The injection site was swollen for over a week and red (like a sunburn)...hot to the touch.
Age: 32.0
Sex: F
Vaccine: ANTH
Symptoms: Muscle spasms, Pyrexia
Clinical narrative: High Fever 105....chills, lymph nodes in left armpit swelled up...cramps throughout body...arches of feet to neck.  The injection site was swollen for over a week and red (like a sunburn)...hot to the touch.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Influenza, Influenza serology positive, Lacrimation increased, Pharyngolaryngeal pain
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  Initial report received on 23 January 2008 from a health care professional.  A 7-year-old male patient, with no concurrent illnesses, and a history of allergies (allergies not defined) and asthma, had received a ninth, intramuscular, left arm dose of FLUZONE No Preservative 2007-2008 (lot number U2457HA) on 03 November 2007.  Eighty-one days after receiving the Fluzone vaccine, the patient developed a fever of 100.7 degrees Fahrenheit, watery eyes, congestion, cough, and sore throat.  A Quick Vue flu test positive for type A and B influenzae.  The patient was prescribed Tamiflu as treatment.  At the time of this report, the patient had not recovered.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Respiratory tract congestion, Vaccination failure
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  Initial report received on 23 January 2008 from a health care professional.  A 7-year-old male patient, with no concurrent illnesses, and a history of allergies (allergies not defined) and asthma, had received a ninth, intramuscular, left arm dose of FLUZONE No Preservative 2007-2008 (lot number U2457HA) on 03 November 2007.  Eighty-one days after receiving the Fluzone vaccine, the patient developed a fever of 100.7 degrees Fahrenheit, watery eyes, congestion, cough, and sore throat.  A Quick Vue flu test positive for type A and B influenzae.  The patient was prescribed Tamiflu as treatment.  At the time of this report, the patient had not recovered.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral, Skin warm, Urticaria
Clinical narrative: Area hot red and swollen, welted up.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Chills, Dehydration, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: 6 hours after vaccination, patient was throwing up and had diarrhea. She had a low-grade fever and chills. Symptoms persisted throughout the night. I brought her to our regular doctor Tuesday morning. He gave her 2 bags of fluid via I.V. for dehydration. Fever of 101.4 continued through out the day along with diarrhea.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Hypersensitivity, Injection site cellulitis, Injection site erythema, Oedema, Skin warm
Clinical narrative: 6-8 cm patch on right upper arm tricep area; 2 cm dark red patch with central punctate; 2 cm surrounding erythema; warm to touch; mild edema; no streaks, no nodes.  Impression: Varicella injection site with secondary cellulitis versus local allergic reaction. Plan: Keflex 500mg TID times 7 days, marked area of erythema at border and return if increased redness, use Benadryl and cool compresses.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Rash
Clinical narrative: On 4Feb08 patient walks in clinic and seen by RN. Pt. C/O of a painful rash on right side of neck. Patient states that he began to experience right side headache during the night of 29 Jan 08.  Plan: Refer to family physician for immediate DX & TX. Patient was seen same day by MD.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test normal, Computerised tomogram normal, Convulsion, Electroencephalogram normal, Haematology test normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA. A 21 year old female patient, on 07-AUG-2007, was vaccinated with the third dose of Gardasil (lot# 658282/0929U). On 07-AUG-2007, two hours after the injection, she fainted, and had "shaking" seizure activity. The patient was taken to the emergency room. At the time of this report, the outcome of the events was unknown. The original reporting source was not provided. No further information is available. Follow up information had been received, via a company representative, in the form of a newspaper article containing a statement made by the patient's mother, who had been present when her daughter had the seizure. The mother noted that the seizure occurred approximately 3 hours after vaccination. She reported that her daughter was followed up by a neurologist, had a computed tomography (CT) scan, magnetic resonance imaging (MRI), blood work, electroencephalogram (EEG), and X-rays, all of which were negative. She added that "none of the physicians would say it was from the vaccine," though she reported her "daughter is perfectly healthy, no medical problems, so I know it was from the vaccine." The outcome of seizures was not specified. Upon internal review, "seizure activity 2 hours after injection" was considered to be serious, as an other important medical event. This report was filed with the FDA. The ISR number is 1-2273704943.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging normal, Syncope, Tremor, X-ray normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA. A 21 year old female patient, on 07-AUG-2007, was vaccinated with the third dose of Gardasil (lot# 658282/0929U). On 07-AUG-2007, two hours after the injection, she fainted, and had "shaking" seizure activity. The patient was taken to the emergency room. At the time of this report, the outcome of the events was unknown. The original reporting source was not provided. No further information is available. Follow up information had been received, via a company representative, in the form of a newspaper article containing a statement made by the patient's mother, who had been present when her daughter had the seizure. The mother noted that the seizure occurred approximately 3 hours after vaccination. She reported that her daughter was followed up by a neurologist, had a computed tomography (CT) scan, magnetic resonance imaging (MRI), blood work, electroencephalogram (EEG), and X-rays, all of which were negative. She added that "none of the physicians would say it was from the vaccine," though she reported her "daughter is perfectly healthy, no medical problems, so I know it was from the vaccine." The outcome of seizures was not specified. Upon internal review, "seizure activity 2 hours after injection" was considered to be serious, as an other important medical event. This report was filed with the FDA. The ISR number is 1-2273704943.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Electrocardiogram normal, Migraine, Nuclear magnetic resonance imaging normal, Paraesthesia, Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a 19 year old female with a history of seasonal sinus headache and seasonal allergy who on 08-Jan-2007 was vaccinated IM with the first 0.5 mL dose of Gardasil (lot #655165/1425F).  On 12-Mar-2007 the patient was vaccinated IM with the second 0.5 mL dose of Gardasil (lot #655165/1425F).  On 17-Jul-2007 the patient was vaccinated IM with the third dose of Gardasil (lot #654272/0319U).  Concomitant therapy included sertraline HC1 (ZOLOFT), alprazolam (XANAX), ethinyl estradiol/norethindrone acetate (ESTROSTEP) and iron (unspecified).  In August 2007 after administration of her third dose of Gardasil, the patient developed migraines.  The patient also experienced a tingling sensation in her extremities, particularly her hands.  The patient fainted twice since her symptoms started.  An MRI and EKG were performed yielding normal results.  Iron levels (Fe) showed low results.  The patient's status was reported as not recovered.  Migraines, tingling sensation in her extremities and fainting were considered to be disabling.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Urine iron decreased
Clinical narrative: Information has been received from a nurse practitioner concerning a 19 year old female with a history of seasonal sinus headache and seasonal allergy who on 08-Jan-2007 was vaccinated IM with the first 0.5 mL dose of Gardasil (lot #655165/1425F).  On 12-Mar-2007 the patient was vaccinated IM with the second 0.5 mL dose of Gardasil (lot #655165/1425F).  On 17-Jul-2007 the patient was vaccinated IM with the third dose of Gardasil (lot #654272/0319U).  Concomitant therapy included sertraline HC1 (ZOLOFT), alprazolam (XANAX), ethinyl estradiol/norethindrone acetate (ESTROSTEP) and iron (unspecified).  In August 2007 after administration of her third dose of Gardasil, the patient developed migraines.  The patient also experienced a tingling sensation in her extremities, particularly her hands.  The patient fainted twice since her symptoms started.  An MRI and EKG were performed yielding normal results.  Iron levels (Fe) showed low results.  The patient's status was reported as not recovered.  Migraines, tingling sensation in her extremities and fainting were considered to be disabling.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test, Computerised tomogram, Convulsion, Electroencephalogram normal, Hypoaesthesia
Clinical narrative: Information has been received from a nurse practitioner concerning a 19 year old female with a history of seasonal sinus headache and seasonal allergy who on 08-Jan-2007 was vaccinated IM with the first 0.5 mL dose of Gardasil (lot #655165/1425F).  On 12-Mar-2007 the patient was vaccinated IM with the second 0.5 mL dose of Gardasil (lot #655165/1425F).  On 17-Jul-2007 the patient was vaccinated IM with the third dose of Gardasil (lot #654272/0319U).  Concomitant therapy included sertraline HC1 (ZOLOFT), alprazolam (XANAX), ethinyl estradiol/norethindrone acetate (ESTROSTEP) and iron (unspecified).  In August 2007 after administration of her third dose of Gardasil, the patient developed migraines.  The patient also experienced a tingling sensation in her extremities, particularly her hands.  The patient fainted twice since her symptoms started.  An MRI and EKG were performed yielding normal results.  Iron levels (Fe) showed low results.  The patient's status was reported as not recovered.  Migraines, tingling sensation in her extremities and fainting were considered to be disabling.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia facial, Migraine, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain normal, Paraesthesia
Clinical narrative: Information has been received from a nurse practitioner concerning a 19 year old female with a history of seasonal sinus headache and seasonal allergy who on 08-Jan-2007 was vaccinated IM with the first 0.5 mL dose of Gardasil (lot #655165/1425F).  On 12-Mar-2007 the patient was vaccinated IM with the second 0.5 mL dose of Gardasil (lot #655165/1425F).  On 17-Jul-2007 the patient was vaccinated IM with the third dose of Gardasil (lot #654272/0319U).  Concomitant therapy included sertraline HC1 (ZOLOFT), alprazolam (XANAX), ethinyl estradiol/norethindrone acetate (ESTROSTEP) and iron (unspecified).  In August 2007 after administration of her third dose of Gardasil, the patient developed migraines.  The patient also experienced a tingling sensation in her extremities, particularly her hands.  The patient fainted twice since her symptoms started.  An MRI and EKG were performed yielding normal results.  Iron levels (Fe) showed low results.  The patient's status was reported as not recovered.  Migraines, tingling sensation in her extremities and fainting were considered to be disabling.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a 19 year old female with a history of seasonal sinus headache and seasonal allergy who on 08-Jan-2007 was vaccinated IM with the first 0.5 mL dose of Gardasil (lot #655165/1425F).  On 12-Mar-2007 the patient was vaccinated IM with the second 0.5 mL dose of Gardasil (lot #655165/1425F).  On 17-Jul-2007 the patient was vaccinated IM with the third dose of Gardasil (lot #654272/0319U).  Concomitant therapy included sertraline HC1 (ZOLOFT), alprazolam (XANAX), ethinyl estradiol/norethindrone acetate (ESTROSTEP) and iron (unspecified).  In August 2007 after administration of her third dose of Gardasil, the patient developed migraines.  The patient also experienced a tingling sensation in her extremities, particularly her hands.  The patient fainted twice since her symptoms started.  An MRI and EKG were performed yielding normal results.  Iron levels (Fe) showed low results.  The patient's status was reported as not recovered.  Migraines, tingling sensation in her extremities and fainting were considered to be disabling.  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Amnesia, Confusional state, Convulsion, Depressed level of consciousness, Dissociative fugue
Clinical narrative: Information has been received from a physician concerning his 11 (also reported as 10) year old granddaughter with no pertinent medical history or drug reactions/allergies who in June 2007, was vaccinated with a first dose of Gardasil (lot# unknown).  There was no concomitant medication.  The patient had 3 seizures.  In June 2007, the patient experienced a seizure 10 days after her first dose of Gardasil.  The first seizure lasted about 90 minutes (also reported as the patient experienced the onset of "a fugue-like" state lasting several hours).  The patient was examined in the emergency room and released.  On an unspecified date in June 2007 the patient had an electroencephalography (EEG) and a magnetic resonance imaging (MRI) and the results were normal.  The patient was not admitted to the hospital.  The patient recovered from the first seizure.  On an unspecified date the patient experienced a brief lack of conscious activity and "appeared to be vacant or far away".  The patient was not experiencing any muscle jerking or twitching during an episode.  In August 2007, the patient experienced a second seizure a few days after her second dose.  The patient recovered from the second seizure.  On 30-JAN-2008 the patient experienced a third seizure in school.  By the time the father arrived at her school the patient was more responsive but still was unable to remember her father's name.  The patient recovered a few minutes later.  The patient is asymptomatic other than the seizures.  The patient had not received her third dose of Gardasil.  No further information was available.  Follow-up information was received from the grandfather who reported that his granddaughter is "transiently confused following these episodes, had no warnings they are starting, and remembers nothing about them".  Upon internal review seizure is considered to be an other medical event.  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Electroencephalogram normal, Nuclear magnetic resonance imaging normal, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning his 11 (also reported as 10) year old granddaughter with no pertinent medical history or drug reactions/allergies who in June 2007, was vaccinated with a first dose of Gardasil (lot# unknown).  There was no concomitant medication.  The patient had 3 seizures.  In June 2007, the patient experienced a seizure 10 days after her first dose of Gardasil.  The first seizure lasted about 90 minutes (also reported as the patient experienced the onset of "a fugue-like" state lasting several hours).  The patient was examined in the emergency room and released.  On an unspecified date in June 2007 the patient had an electroencephalography (EEG) and a magnetic resonance imaging (MRI) and the results were normal.  The patient was not admitted to the hospital.  The patient recovered from the first seizure.  On an unspecified date the patient experienced a brief lack of conscious activity and "appeared to be vacant or far away".  The patient was not experiencing any muscle jerking or twitching during an episode.  In August 2007, the patient experienced a second seizure a few days after her second dose.  The patient recovered from the second seizure.  On 30-JAN-2008 the patient experienced a third seizure in school.  By the time the father arrived at her school the patient was more responsive but still was unable to remember her father's name.  The patient recovered a few minutes later.  The patient is asymptomatic other than the seizures.  The patient had not received her third dose of Gardasil.  No further information was available.  Follow-up information was received from the grandfather who reported that his granddaughter is "transiently confused following these episodes, had no warnings they are starting, and remembers nothing about them".  Upon internal review seizure is considered to be an other medical event.  Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: RV5
Symptoms: Appendicectomy, Decreased appetite, Diarrhoea, Explorative laparotomy, Intussusception
Clinical narrative: Information has been received from a post-marketing evaluation program concerning a 5 month old female who was vaccinated PO with the first dose of Rotateq.  Subsequently 7 days post dose, the patient was brought to the office with complaints of vomiting, diarrhea, poor appetite.  The patient was admitted for exploratory laparotomy with reduction of partial volvulus, resection of Meckel's diverticulum and appendectomy and was hospitalized for 6 days.  The patient was discharged on day 6 with a diagnosis of ileocolic intussusception with partial volvulus.  Subsequently, the patient recovered.  The events were considered to be other important medical events (surgery) by the reporter.  Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: RV5
Symptoms: Vitello-intestinal duct remnant, Volvulus, Vomiting
Clinical narrative: Information has been received from a post-marketing evaluation program concerning a 5 month old female who was vaccinated PO with the first dose of Rotateq.  Subsequently 7 days post dose, the patient was brought to the office with complaints of vomiting, diarrhea, poor appetite.  The patient was admitted for exploratory laparotomy with reduction of partial volvulus, resection of Meckel's diverticulum and appendectomy and was hospitalized for 6 days.  The patient was discharged on day 6 with a diagnosis of ileocolic intussusception with partial volvulus.  Subsequently, the patient recovered.  The events were considered to be other important medical events (surgery) by the reporter.  Additional information has been requested.
Age: 0.54
Sex: M
Vaccine: DTAP, HIBV, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated PO with a 2.0 ml dose of Rotateq (no lot# provided) (dose of series unknown).  Subsequently the patient experienced intussusception.  The patient sought unspecified medical attention.  Subsequently, the patient recovered from intussusception.  There was no product quality complaint.  Upon internal review, intussusception was determined to be an other important medical event.  This is one of two reports from the same source.  Additional information has been requested.  03/31/2008 MR received for DOS 10/3-5/2008 with DX:  Intussusception.  S/P Laparoscopic Appendectomy and reduction of Intussusception. Infant presented with fever, vomiting, abdominal pain and bloody stool.  Abd US (+) for IS and pt transferred to current facility for Tx. Unable to reduce by Barium Enema so taken to OR for surgical reduction. D/C home on POD#2.
Age: 0.2
Sex: F
Vaccine: HIBV, PNC, RV5, TDAP
Symptoms: Haematochezia, Occult blood positive
Clinical narrative: Information has been received from a registered nurse concerning a 9 week old female with no pertinent medical history or drug allergies who on 28-Jan-2008 in the morning was vaccinated PO with her first 2.0 ml dose of Rotateq (lot #658386/1734U).  Concomitant vaccinations administered on that same day included a dose of PREVNAR, a dose of ACTHIB and a dose of Tdap.  On that same day in the afternoon, the patient experienced blood in stools.  The patient sought medical attention at the physician's office.  The office performed a hemoccult test to monitor the patient's stool which was positive for blood.  It was also noted that the patient was not seriously ill and did not have a diagnosis.  At the time of this report the patient was not recovered.  There was no product quality complaint.  Upon internal review, blood in stool was determined to be an other important medical event.  Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased
Clinical narrative: Ptnt administered Adacel 09/19/2007 post partum. Admitted 9/23/07 with severe cellulitis, temp 104.7; IV Vancomycin therapy, recovered. 2/27/08-records received for DOS 9/23-9/26/07-DC DX: Right arm cellulitis status post DPT shot. Admitted with temperature of 103.4. Erythema at injection site, injection site warmth and tenderness and crusted lesions.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Death, Intensive care, Malaise, Mechanical ventilation
Clinical narrative: She was immediately sick.  Very sick for 4 more days.  Kept getting worse.  Dec 20 put in hospital.  Dec 25 to ICU.  Dec 27 respirator.  Died 1/17/08.  2/21/08 Reviewed hospital medical records which included clinic visit & vax record of 11/28/07.  Database updated.  Patient w/palpitations intermittently when anxious or blood sugar low, 10# wt loss over past several months since the death of parent. H&P indicates patient experienced sinusitis, fever, chills, sore throat, nasal congestion, postnasal drip, swollen cervical lymph nodes & productive cough x 3 wks.  Dx w/bronchitis & pneumonia & tx w/oral antibiotics as outpatient w/o increasing fever, SOB & weakness.  Admitted 12/20/07-01/17/2008 w/community acquired pneumonia & dehydration.  Consults by pulmonogy, surgery & ID.  Conditioned worsened & was intubated & transferred to ICU.  Developed pneumothorax s/p transbronchial biopsy & had chest tube placed.  Developed acute ARDS & was trached 1/8/08. Continued to deteriorate & expired 1/17/2008. FINAL DX: none provided on D/C summary.  No autopsy done per med records.  Death certificate requested from funeral home. 2/21/08 Reviewed death certificate which states COD as respiratory failure with pneumonia as underlying cause.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling, Rash macular
Clinical narrative: R upper arm with swelling, macular rash and tenderness.  Itch/pain.  Prescribed Benadryl pru, Motrin PO pru.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC
Symptoms: Body temperature increased, Diarrhoea, Food intolerance, Vomiting
Clinical narrative: Baby threw-up all night day of administration.  Continued to vomit, did not retain any feeds.  Pt was taken to ER on the 20th.  No h/o excessive crying.  Temp T max 100.4.  Mom kept baby home.  He recovered in 1.5 days.  He had mild diarrhea also.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Blood immunoglobulin E, Cellulitis, Erythema, Full blood count
Clinical narrative: Redness, swelling, weakness and pain 24 hours after. T 98.4. No adenopathy? cellulitis. RX with Rocephin 1gm and start Keflex. Discolorization of arm which is resolving. Advised Td in future - No Tdap. per ID doctor.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Skin discolouration, Swelling
Clinical narrative: Redness, swelling, weakness and pain 24 hours after. T 98.4. No adenopathy? cellulitis. RX with Rocephin 1gm and start Keflex. Discolorization of arm which is resolving. Advised Td in future - No Tdap. per ID doctor.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Feeling hot, Rash generalised, Skin warm
Clinical narrative: Rash all over body - warm to touch.  Pt states she feels like she's "on fire".  Given Epi & 40 mg Depo Medrol.  Sent home with.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash generalised
Clinical narrative: Rash all over body - warm to touch.  Pt states she feels like she's "on fire".  Given Epi & 40 mg Depo Medrol.  Sent home with.
Age: 10.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Blister, Erythema, Oedema peripheral, Skin warm
Clinical narrative: Erythemic, edematous, warm left arm with 3 blisters (small).
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: 10 days after injection pain at L deltoid site-began right after injection 1-18-08; seen by MD 1-28-08 with c/o pain from "neck down to fingers"; guarding arm & not using L hand.  Positive tenderness at site of injection with pain at L deltoid-no firmness, no redness, positive pain with passive ROM >90 degrees.  Motrin 400mg po q 6 hours x2 days.  Recheck 48 hours.
Age: 17.0
Sex: M
Vaccine: DTAP, MNQ
Symptoms: Chills, Fatigue, Pain, Pain in extremity, Pyrexia
Clinical narrative: Patient received Menactra and Tdap - started having sore arms that night, then next day.  Low grade fever, chills.  Also pain, fatigue.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: Left arm, left hand swollen 2x1.  Left upper arm swollen red 3x5.  Vaccine reaction with distant reaction too, itchy.  Rx Zyrtec.
Age: 1.3
Sex: F
Vaccine: DTAPH, FLU3, PNC
Symptoms: Injection site swelling
Clinical narrative: Extensive limb (L) swelling.
Age: 1.2
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Generalized mocular-papular rash appeared on trunk.  Mild congestion, low grade fever for 1 week.  Treatment: Calamine lotion, Tylenol, Benadryl.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Erythema, Injection site erythema, Injection site induration, Mobility decreased
Clinical narrative: Vaccine given in office 1/17/08.  Seen in our office 1/30 with R thigh marked by indurated & erythematous circle 2cm.  Clear vesicle noted.  Several red papules on R wrist & forearm.  Being treated for LOM.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash papular
Clinical narrative: Vaccine given in office 1/17/08.  Seen in our office 1/30 with R thigh marked by indurated & erythematous circle 2cm.  Clear vesicle noted.  Several red papules on R wrist & forearm.  Being treated for LOM.
Age: 4.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Anaphylactic reaction, Oxygen saturation decreased, Wheezing
Clinical narrative: Anaphylaxis 10 min after MMR, VZV, HAV boosters.  Treated with Epinephrine 0.2mg SQ x2, Prednisolone PO 30mg, Benadryl 19mg PO.  911 to ER.
Age: 47.0
Sex: F
Vaccine: TD
Symptoms: Fatigue, Influenza like illness, Myalgia, Pyrexia, Rash
Clinical narrative: 01/18/08-Flu-like muscular pains, fatigue, low fever.  01/19/08-Rash on back of hands.  01/20/08-Rash spread to wrists & arms.  01/21/08-Rash spread to thighs, legs & ankles.  01/27/08-Welts in rash on upper thighs.
Age: 47.0
Sex: F
Vaccine: TD
Symptoms: Urticaria
Clinical narrative: 01/18/08-Flu-like muscular pains, fatigue, low fever.  01/19/08-Rash on back of hands.  01/20/08-Rash spread to wrists & arms.  01/21/08-Rash spread to thighs, legs & ankles.  01/27/08-Welts in rash on upper thighs.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Erythema, Injection site streaking, Pain, Pyrexia
Clinical narrative: Thurs: aches and pains, red arm; Fri: aches and pains, fever 102+, chills, red area on upper left arm, 3" by 3" which was warm to touch, with red lines going to underarm; Sat: aches and pains, fever 102+, red area increased to 6" by 6" with deeper red; Sun: same; Red area took over 1 week to lighten. Have pictures of the arm. Treatment: took doses of Tylenol and Benadryl every two to three hours, plus ice applied to arm.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Thurs: aches and pains, red arm; Fri: aches and pains, fever 102+, chills, red area on upper left arm, 3" by 3" which was warm to touch, with red lines going to underarm; Sat: aches and pains, fever 102+, red area increased to 6" by 6" with deeper red; Sun: same; Red area took over 1 week to lighten. Have pictures of the arm. Treatment: took doses of Tylenol and Benadryl every two to three hours, plus ice applied to arm.
Age: 0.53
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC, RV5
Symptoms: Abdominal pain, Barium enema, Bowel movement irregularity, Gastroenteritis viral, Gastrointestinal sounds abnormal
Clinical narrative: The patient presented in the office on November 16, 2007 with vomiting, cramping abdominal pain.  She had not had a bowel movement for 2 days.  Her abd./gastro was soft and hypoactive.  She was diagnosed with viral gastroenteritis.   Pt. mom was told to supplement with Pedialyte 1/2 ounce every 15-20 minutes until the patient had not vomited for 6 hours.  She was told no solids for 24 hours and to give Mylicon drops every 4 hours as needed.  She was also told to go to the ER if it worsened over the weekend.  The patient then presented to the Emergency Room 11/18/2007 at 4:15 a.m. with worsening symptoms.  The ER did a KUB that showed nonspecific bowel gas pattern the ER physcian then consulted a General Surgeon who ordered an abdominal ultrasound.  The abdominal ultrasound was postive for intussusception localized in the right upper quadrant mainly pointing at an ileoceal or ileo-ascending colon intussusception.  The patient then underwent a hydrostatic barium enema reduction of her intussusception that failed.  So the patient was then transported to another facility where the intussuception was reduced.  2/7/08 vax rec received; no update needed- vax/lot # are as reported. 2/8/08 Reviewed ER medical records which reveal patient experienced abdominal pain & bilious vomiting x 3 days.  Transferred to higher level of care for peds surgical consult. 2/19/08 Reviewed hospital medical records which reveal patient experienced IS unable to reduce via BE at outlying hospital.  Had bilious emesis & abdominal pain 3 days prior to admit,  seen by pcp & dx w/recurrence of viral infection.  Resolved & recurred again & crying inconsolably.  Admitted 11/18-11/19/2007.  Surgical consult done.   FINAL DX: Intussusception, enema reduced.
Age: 0.53
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC, RV5
Symptoms: Intussusception, Ultrasound abdomen abnormal, Urinary system X-ray
Clinical narrative: The patient presented in the office on November 16, 2007 with vomiting, cramping abdominal pain.  She had not had a bowel movement for 2 days.  Her abd./gastro was soft and hypoactive.  She was diagnosed with viral gastroenteritis.   Pt. mom was told to supplement with Pedialyte 1/2 ounce every 15-20 minutes until the patient had not vomited for 6 hours.  She was told no solids for 24 hours and to give Mylicon drops every 4 hours as needed.  She was also told to go to the ER if it worsened over the weekend.  The patient then presented to the Emergency Room 11/18/2007 at 4:15 a.m. with worsening symptoms.  The ER did a KUB that showed nonspecific bowel gas pattern the ER physcian then consulted a General Surgeon who ordered an abdominal ultrasound.  The abdominal ultrasound was postive for intussusception localized in the right upper quadrant mainly pointing at an ileoceal or ileo-ascending colon intussusception.  The patient then underwent a hydrostatic barium enema reduction of her intussusception that failed.  So the patient was then transported to another facility where the intussuception was reduced.  2/7/08 vax rec received; no update needed- vax/lot # are as reported. 2/8/08 Reviewed ER medical records which reveal patient experienced abdominal pain & bilious vomiting x 3 days.  Transferred to higher level of care for peds surgical consult. 2/19/08 Reviewed hospital medical records which reveal patient experienced IS unable to reduce via BE at outlying hospital.  Had bilious emesis & abdominal pain 3 days prior to admit,  seen by pcp & dx w/recurrence of viral infection.  Resolved & recurred again & crying inconsolably.  Admitted 11/18-11/19/2007.  Surgical consult done.   FINAL DX: Intussusception, enema reduced.
Age: 3.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Rash macular
Clinical narrative: There is a slightly tender, warm, erythematous macule over the left lateral thigh, about 5 x 8 cm in size.  It is slightly elevated.