chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Intestinal obstruction, Surgery
Clinical narrative: Information has been received from a physician concerning a 2 month old male with a history of abdominal surgery prior to vaccination who on 02-APR-2008 was vaccinated PO with his first dose of Rotateq. On 08-APR-2008 the patient was diagnosed with a bowel obstruction. The patient was hospitalized and had surgery on 14-APR-2008 and was still recovering. The physician concluded that "the bowel obstruction was caused by scar tissue from the previous abdominal surgery. "There was no product quality complaint. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Autoimmune disorder, Pancreatitis
Clinical narrative: Information has been received from a nurse practitioner concerning her father, a 69-year-old male who on 18-APR-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  The next day, on 19-APR-2008, the patient developed autoimmune pancreatitis and was hospitalized.  No other information was provided.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Fatigue, Headache, Lymphadenopathy, Pharyngolaryngeal pain
Clinical narrative: 4/21/08 Patient received Gardasil 2/20/08 at right deltoid. Patient complained of that next day increased swollen glands at neck. Right side - size of a "golf ball" x 4 weeks - completely resolved additional 4wks as decrease in size. Patient complained of fatigue, exhaustion, sore throat, headache. No pain at deltoid, only reaction was on right side. Patient did not go to MD due to no insurance, but states was in bed (totally) x 3 days - then long recovery x 1 wk before normal activities; CRNP aware of patient reaction.
Age: 11.0
Sex: F
Vaccine: DTAP, MNQ
Symptoms: Headache, Inappropriate schedule of drug administration, Pyrexia
Clinical narrative: non-DTaP was given to this pt and she is age 11. No adverse events occurred  mom reported 1 d after immunization, pt had 102 fever with headache, lasted 2d, sibling with similar sx. Fever and HA resolved in 2d. No problems since.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Body temperature increased, Erythema, Pain of skin, Skin warm
Clinical narrative: (R) lower arm 5cm x 6cm area of erythema, warmth, tenderness; low grade fever. Benadryl QHS, Zantac AM; cool compresses.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Pyrexia, Vomiting
Clinical narrative: Mother states son awoke 12/22 AM with 99 degree temp and vomiting. 3.5x2.25cm reddened area noted on top of (L) thigh yesterday (12/21) - area is swollen, warm to touch and reddened at this time. T 96.9 ax.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Dx red and swollen and warm. Tx: cold compress and Zyrtec and Motrin.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Swelling and redness (L) deltoid with pain.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, Convulsion
Clinical narrative: Information has been received from a physician concerning a 21 year old female with no medical history and no drug allergies, who on 13-AUG-2007 was vaccinated with a first dose of Gardasil. On 15-OCT-2007 the patient was vaccinated IM with a 0.5 mL second dose of Gardasil (Lot# 658558/1061U). There was no concomitant medication. On 21-NOV-2007 the patient experienced a seizure. The patient was seen by the physician. A computed axial tomography (CAT scan) was performed. The patient recovered on an unspecified date. No product quality complaint was involved. Upon internal review seizure was considered to be an other important medical event. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: FLUX, HPV4, MNQ
Symptoms: Activities of daily living impaired, Arthralgia, Dysuria, Eyelid oedema, Fatigue
Clinical narrative: Information has been received from a physician concerning a 14 year old female with asthma and no drug allergies, who in November 2007 was vaccinated with a first dose of GARDASIL.  There was no concomitant medication.  Subsequently, two or three weeks post vaccination the patient developed an enlarged spleen, swollen liver, high liver enzymes, swollen eye lids, weight loss, difficulty urinating, fever, fatigue, joint pain, and swollen glands.  The patient had been out of school and was hospitalized for approximately one week.  The following tests were performed: mononucleosis, lupus, rheumatoid arthritis, hepatitis, lime disease, and many other lab tests.  At the time of the report the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.  5/19/2008 MR received for DOS 3/4-8/2008 with D/C DX: Viral Syndrome.  Pt presented to ER with 5 day hx of fevers, difficulty urinating, fatigue, abdominal and flank pain as well as eyelid swelling. Pt reports knee, elbow and joint pain. PE (+) for periorbital swelling and abdominal tenderness. Tx with ceftriaxone.
Age: 13.0
Sex: F
Vaccine: FLUX, HPV4, MNQ
Symptoms: Pyrexia, Splenomegaly, Weight decreased
Clinical narrative: Information has been received from a physician concerning a 14 year old female with asthma and no drug allergies, who in November 2007 was vaccinated with a first dose of GARDASIL.  There was no concomitant medication.  Subsequently, two or three weeks post vaccination the patient developed an enlarged spleen, swollen liver, high liver enzymes, swollen eye lids, weight loss, difficulty urinating, fever, fatigue, joint pain, and swollen glands.  The patient had been out of school and was hospitalized for approximately one week.  The following tests were performed: mononucleosis, lupus, rheumatoid arthritis, hepatitis, lime disease, and many other lab tests.  At the time of the report the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.  5/19/2008 MR received for DOS 3/4-8/2008 with D/C DX: Viral Syndrome.  Pt presented to ER with 5 day hx of fevers, difficulty urinating, fatigue, abdominal and flank pain as well as eyelid swelling. Pt reports knee, elbow and joint pain. PE (+) for periorbital swelling and abdominal tenderness. Tx with ceftriaxone.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning an approximately eleven or twelve year old female patient who was vaccinated with the third dose of GARDASIL.  Subsequently, after receiving the third dose of GARDASIL, the patient "went into a" seizure.  The seizure lasted a couple of seconds and then the patient was "ok."  The patient sought unspecified medical attention.  It was reported that the patient was "ok" after receiving the first and second doses of GARDASIL.  No product quality complaint was involved.  Upon internal review, seizure was considered to be an other important medical event.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a representative as told by a physician "in conversation patient's mother mentioned her friend's daughter who was vaccinated with GARDASIL and mentioned the reason she will not let her daughter receive the vaccine is because her friend's daughter experienced convulsions after receiving GARDASIL". No further information was provided as the representative did not have direct contact or conversation with the patient. Upon internal review convulsion is considered to be an other medical event.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Computerised tomogram, Convulsion, Head injury, Headache
Clinical narrative: Information has been received from an office manager at a physician's office concerning a 20 year old female who was vaccinated with a first dose of GARDASIL (lot number, route and site not reported) on an unspecified date.  The patient received a second dose of GARDASIL (lot number not reported) intramuscularly on an unspecified date.  The office manager reported that the patient fainted and hit her head on a railing while making an appointment for her third dose at the receptionist desk.  The patient also became hypertensive, began seizing, and throwing up.  The patient was admitted to the hospital where she received 7 stitches.  A computed axial tomography was performed (results not reported).  The patient was admitted on 09-APR-2008 and released on 10-APR-2008.  After being released the patient is still experiencing pain at the injection site, headaches, nausea and back pain.  At the time of reporting the patient had not recovered.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Hypertension, Injection site pain, Nausea, Suture insertion, Syncope
Clinical narrative: Information has been received from an office manager at a physician's office concerning a 20 year old female who was vaccinated with a first dose of GARDASIL (lot number, route and site not reported) on an unspecified date.  The patient received a second dose of GARDASIL (lot number not reported) intramuscularly on an unspecified date.  The office manager reported that the patient fainted and hit her head on a railing while making an appointment for her third dose at the receptionist desk.  The patient also became hypertensive, began seizing, and throwing up.  The patient was admitted to the hospital where she received 7 stitches.  A computed axial tomography was performed (results not reported).  The patient was admitted on 09-APR-2008 and released on 10-APR-2008.  After being released the patient is still experiencing pain at the injection site, headaches, nausea and back pain.  At the time of reporting the patient had not recovered.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from an office manager at a physician's office concerning a 20 year old female who was vaccinated with a first dose of GARDASIL (lot number, route and site not reported) on an unspecified date.  The patient received a second dose of GARDASIL (lot number not reported) intramuscularly on an unspecified date.  The office manager reported that the patient fainted and hit her head on a railing while making an appointment for her third dose at the receptionist desk.  The patient also became hypertensive, began seizing, and throwing up.  The patient was admitted to the hospital where she received 7 stitches.  A computed axial tomography was performed (results not reported).  The patient was admitted on 09-APR-2008 and released on 10-APR-2008.  After being released the patient is still experiencing pain at the injection site, headaches, nausea and back pain.  At the time of reporting the patient had not recovered.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy, Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Initial and follow up information has been received from a health professional for Merck Pregnancy Registry, concerning a 24 year old female patient who had an allergy to aspirin and had an abnormal cervical smear on 28-FEB-2008 which showed atypical cells. Patient was positive for human papilloma virus (exact stain was not known). On 07-MAR-2008 she was vaccinated IM with her first dose of GRADASIL (lot # 655504/0052X). It was reported that there was no concomitant medication. The home pregnancy test showed that the patient was pregnant. The medical assistant mentioned that the patient was going to have an office visit on 18-Mar-2008. In follow up information from the doctor's office it was reported that her last menstrual period was 15-FEB-2008 and expected delivery date would be 21-NOV-2008. On 23-MAR-2008 patient had an elective abortion which was five weeks after the LMP. The outcome of the event was unknown. Upon internal review elective termination of pregnancy was determined to be an other important medical event. Additional information is not expected.
Sex: M
Vaccine: MMR
Symptoms: Autism, Immediate post-injection reaction
Clinical narrative: Information has been received from a health professional concerning a male child who was vaccinated with a dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3).  The patient's mother reported that her child developed autism immediately after receiving the vaccination.  A product quality complaint was not involved.  Upon internal review, autism was determined to be an other important medical event.  No further information is available.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC, RV5, DTAPHEPBIP, FLU3, HIBV, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician concerning an 8 month old male who on 05-OCT-2007, 01-DEC-2007 and 08-FEB-2008 was vaccinated PO with his first, second and third "standard" doses of Rotateq.  Concomitant vaccinations included "other routine vaccines."  Subsequently the patient experienced intussusception went to an emergency room and was subsequently hospitalized.  The patient had surgery on 14-APR-2008.  Subsequently, the patient recovered and was discharged from the hospital.  There was no product quality complaint.  Intussusception was also considered to be an other important medical event (surgery) by the physician.  Additional information has been requested. 8/11/08-records received for DOS 3/26-3/29/08-DC DX: Intussusception. Leukocytosis. Presented to ED with screaming, vomiting and difficulty breathing, abdominal pain, inconsolable. Last BM day before. Exploratory laparotomy with incidental appendectomy.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Convulsion, Lethargy, Pyrexia
Clinical narrative: Initial report was received 17 April 2008 from a consumer, who is the patient's parent. a four-month-old male patient with no pre-existing medical conditions, had received a second dose injection of DTaP, and a second dose injection of Hib vaccine, and a second dose of Polio vaccine (manufacturers, lot numbers, route/sites of administration not provided) on 31 August 1992 and within hours of vaccination, he developed a fever of 108 degrees Farenheit (rectally) and became lethargic. The patient was taken to the emergency room where he experienced two to three episodes of convulsions back to back. Motrin and Tylenol were administered but were not effective in reducing the fever. The patient was placed in a tub of cool water and the fever gradually lowered to 100-101 degrees Fahrenheit. The patient was sent home and had not been admitted to the hospital. The fever resolved and the patient fully recovered from the event. It was noted by the reporter that this patient experienced a fever of 100-101 degrees Fahrenheit after receipt of their first dose of DTaP, Hib and Polio vaccinations at two months of age. No further information was provided at the time of the report. Documents held by sender: Certificate of Immunizations. This patient experienced two other events which have been captured in cases 2008-01108 and 2008-01110.
Age: 9.0
Sex: M
Vaccine: PNC, PPV
Symptoms: Inflammation, Pyrexia
Clinical narrative: LEFT UPPER EXTREMITY INFLAMMATORY IMMUNIZATION REACTION TO PNEUMOVAX OR PREVNAR, FEVER, POSSIBLE EARLY CELLULITIS, GIVEN KEFLEX 250/5 2 TSP. PO TID X 7 DAYS, PREDNISONE 10 MG 2 X 1 THEN 1 QD X 2, IBUPROFEN 400 Q 8 HOURS PRN.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Body temperature increased, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: On 23 April 2008, member felt nauseous around midnight.  Member began feeling joint pains in legs/hips and overall aches.  At 1000 on 24 April 2008 member's temp. was 99.9 F at 1200 temp. went up to 101.0F and at 1400 on 24 April 2008 it was 101.9F. Member began to take ibuprofen same day and the fever broke around 2000.  Site of injection swollen and red about 1-1 1/2 inch diameter area.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Pain
Clinical narrative: On 23 April 2008, member felt nauseous around midnight.  Member began feeling joint pains in legs/hips and overall aches.  At 1000 on 24 April 2008 member's temp. was 99.9 F at 1200 temp. went up to 101.0F and at 1400 on 24 April 2008 it was 101.9F. Member began to take ibuprofen same day and the fever broke around 2000.  Site of injection swollen and red about 1-1 1/2 inch diameter area.
Age: 1.25
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Abnormal behaviour, Blood test, Bowel movement irregularity, Clumsiness, Computerised tomogram
Clinical narrative: Developed fever of 105 for two days ten days following immunizations.  Shortly after began showing unsteady gait and clumsiness.  Also began drinking excessively, having sporadic appetite, and irregular bowel movements with both diarrhea and constipation.  Sudden onset severe sleep disturbance (day and night) and sudden onset behavioral disruption.
Age: 1.25
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Constipation, Decreased appetite, Diarrhoea, Gait disturbance, Pyrexia
Clinical narrative: Developed fever of 105 for two days ten days following immunizations.  Shortly after began showing unsteady gait and clumsiness.  Also began drinking excessively, having sporadic appetite, and irregular bowel movements with both diarrhea and constipation.  Sudden onset severe sleep disturbance (day and night) and sudden onset behavioral disruption.
Age: 1.25
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Sleep disorder, Thirst, Urine analysis
Clinical narrative: Developed fever of 105 for two days ten days following immunizations.  Shortly after began showing unsteady gait and clumsiness.  Also began drinking excessively, having sporadic appetite, and irregular bowel movements with both diarrhea and constipation.  Sudden onset severe sleep disturbance (day and night) and sudden onset behavioral disruption.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Full blood count normal, Irritability, Lethargy, Pyrexia
Clinical narrative: 104 degree fever, treated with Tylenol and Ibuprofen (alternating medicines every two hours) and cool baths. Has lasted four days, and she is still ill. Very lethargic, cranky.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Contusion, Full blood count, Petechiae
Clinical narrative: Bruising, palatal petechiae. 6/30/2008 MR received for OV 4/25/2008 with c/o bruising following both Gardasil injections.  Petechiae noted on posterior palate and bruising on arms and legs.
Age: 31.0
Sex: F
Vaccine: RAB
Symptoms: Abdominal pain, Asthenia, Aura, Fatigue, Hot flush
Clinical narrative: Abdomen pain, sore neck, L arm pain (17 Apr 08/1045; 5 hrs). Visual Auras w/migraine, nausea, hot flashes, light/noise/smell sensitivity (18 Apr/1150; 6 hrs). Facial sinus pain under eyes, fatigue/weakness, sore throat, L arm pain, abdomen pain, R ear ringing, light/noise sensitivity (19-24 Apr/all days).
Age: 31.0
Sex: F
Vaccine: RAB
Symptoms: Migraine, Nausea, Neck pain, Pain in extremity, Pharyngolaryngeal pain
Clinical narrative: Abdomen pain, sore neck, L arm pain (17 Apr 08/1045; 5 hrs). Visual Auras w/migraine, nausea, hot flashes, light/noise/smell sensitivity (18 Apr/1150; 6 hrs). Facial sinus pain under eyes, fatigue/weakness, sore throat, L arm pain, abdomen pain, R ear ringing, light/noise sensitivity (19-24 Apr/all days).
Age: 31.0
Sex: F
Vaccine: RAB
Symptoms: Phonophobia, Photophobia, Sinus headache, Tinnitus
Clinical narrative: Abdomen pain, sore neck, L arm pain (17 Apr 08/1045; 5 hrs). Visual Auras w/migraine, nausea, hot flashes, light/noise/smell sensitivity (18 Apr/1150; 6 hrs). Facial sinus pain under eyes, fatigue/weakness, sore throat, L arm pain, abdomen pain, R ear ringing, light/noise sensitivity (19-24 Apr/all days).
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: 50 mm induration and erythema, warm to touch beginning the morning after injection. Client states putting ice to site made it worse.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: I felt like I got the flu. Had a running nose, felt aches and joint pains along with a fever. It lasted seven days.
Age: 49.0
Sex: M
Vaccine: TD
Symptoms: Expired drug administered
Clinical narrative: EXPIRED TD VACCINE ADMINISTERED TO THE PATIENT.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Facial palsy, Fatigue
Clinical narrative: 3/24/08 had symptoms of fatigue, right sided facial paralysis.  Diagnosed with Bell's Palsy.
Age: 26.0
Sex: F
Vaccine: DT
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Employee reports onset of redness and swelling to injection site to right deltoid a few hours after injection.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Feeling of body temperature change, Rash papular
Clinical narrative: Patient's md called pharmacy to report that patient had gone to md office with diffuse papular rash with a lot of erythema on chest, back and legs with joint pain. Patient reported she had developed hot and cold flashes within 5 hours of injection.
Age: 36.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Rash papular, Skin lesion
Clinical narrative: Multiple red papular lesions distant from vaccination site - on abdomen, anterior neck, left upper arm.  Lesions are nonpruritic.  No vesicles or pustules.  No signs of anaphylaxis.  Patient looks and feels well otherwise.  No fever or chills.  No treatment provided.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Erythema 9x11cm left deltoid.  No induration, slight warmth, slight tenderness.
Age: 0.64
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV
Symptoms: Febrile convulsion, Grand mal convulsion, Inappropriate schedule of drug administration, Pyrexia
Clinical narrative: According to the mother, child was vaccinated in the morning and in the evening she came down with a fever.  Just as she was about to take the temperature, child had a full tonic clonic febrile seizure that lasted 2 minutes. Mom immediately called 911 and the ambulance to the child to Medical Center.  Child was examined and Tylenol administered.  Child was released after 3 hours. Follow up at PMD today for assessment.
Age: 0.16
Sex: F
Vaccine: HIBV, PNC
Symptoms: Crying, Injection site erythema, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: Had only two imminizations today. Prevnar in Left thigh about 1 hour later red hot and swelling down to Left knee. Very fussy and crying, screaming if touched at site.  Mother gave a bath and swelling decreased but stayed larger than a 50 cent piece. Came back to office for exam Tylenol given, cool washcloth and will Not give Prevnar in future. Documented in chart.
Age: 0.16
Sex: F
Vaccine: HIBV, PNC
Symptoms: Screaming
Clinical narrative: Had only two imminizations today. Prevnar in Left thigh about 1 hour later red hot and swelling down to Left knee. Very fussy and crying, screaming if touched at site.  Mother gave a bath and swelling decreased but stayed larger than a 50 cent piece. Came back to office for exam Tylenol given, cool washcloth and will Not give Prevnar in future. Documented in chart.
Age: 1.0
Sex: M
Vaccine: HEP, HIBV, MMR, VARCEL
Symptoms: Aphasia, Catatonia, Communication disorder, Immediate post-injection reaction, Influenza like illness
Clinical narrative: On 12-19-06, patient rec'd the MMR, HIB, Hep B & Varicella vaccinations. He should not have had the shots since he was recovering from a cold but the Dr. never told us that. My husband & I refused the MMR shot several times while in the Dr's office but we were intimidated by the Dr & his staff to give it. Patient immediately developed flu-like symptoms & a full body rash. The flu symptoms lasted about 2 wks & the rash about 2 days. Patient lost speech & communication including up to 15 words he had learned. Patient became catatonic & non-responsive to physical & verbal cues. Patient began Tx with a Holistic Physician immediately who placed him on a wheat-free, gluten-free, dairy-free diet including holistic vitamins & probiotics. Patient currently is developing physically, verbally & cognitively at a normal level for his age. He has met all of his major milestones. Patient is a fraternal twin & IVF baby using PGD.
Age: 1.0
Sex: M
Vaccine: HEP, HIBV, MMR, VARCEL
Symptoms: Rash generalised, Unresponsive to stimuli
Clinical narrative: On 12-19-06, patient rec'd the MMR, HIB, Hep B & Varicella vaccinations. He should not have had the shots since he was recovering from a cold but the Dr. never told us that. My husband & I refused the MMR shot several times while in the Dr's office but we were intimidated by the Dr & his staff to give it. Patient immediately developed flu-like symptoms & a full body rash. The flu symptoms lasted about 2 wks & the rash about 2 days. Patient lost speech & communication including up to 15 words he had learned. Patient became catatonic & non-responsive to physical & verbal cues. Patient began Tx with a Holistic Physician immediately who placed him on a wheat-free, gluten-free, dairy-free diet including holistic vitamins & probiotics. Patient currently is developing physically, verbally & cognitively at a normal level for his age. He has met all of his major milestones. Patient is a fraternal twin & IVF baby using PGD.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Death, Loss of consciousness
Clinical narrative: Sudden loss of consciousness several hours after vaccination.  EMT could not revive him.  Physical and EKG were normal just 3 days prior at annual exam.  4/29 Autopsy report states COD as atherosclerotic coronary vascular disease.  Manner of death is natural.  4/29 Autopsy states patient found unresponsive & cyanotic at bottom of ladder with a drill (no malfunction).  ASCVD findings: LAD & circumflex arteries to pinpoint lumen; RCA 80% narrowing; aorta w/ulcerated plaque partly occluding left coronary ostium; previous MI, extensive involving lateral LV w/aneurysmal thinning of ventricular wall.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Decreased appetite, Pyrexia, Rash
Clinical narrative: Gardasil administered 4/16/08. On 4/20/08 fever at 103. Seen by primary care physician treated with Amoxicillin and then got a rash. Today 4/25/08 with low grade temp 101. Appetite slightly better. Has returned to school.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, IPV, VARCEL
Symptoms: Hyperhidrosis, Nausea, Pallor, Palpitations, Presyncope
Clinical narrative: 5 PM Few seconds after GARDASIL was injected to (L) deltoid IM, patient developed nausea, palpitation, to drowsiness, pyrexia followed. Developed pallor, diaphoresis to pre-syncopal attack. Tachy, stimulation applied; patient then reported nausea and subsequently vomited. After this pallor resolved and regained full consciousness. T 99, BP 100/70. Fully recovered, stood up, walked and discharged. Duration 15 minutes.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, IPV, VARCEL
Symptoms: Pyrexia, Somnolence, Vomiting
Clinical narrative: 5 PM Few seconds after GARDASIL was injected to (L) deltoid IM, patient developed nausea, palpitation, to drowsiness, pyrexia followed. Developed pallor, diaphoresis to pre-syncopal attack. Tachy, stimulation applied; patient then reported nausea and subsequently vomited. After this pallor resolved and regained full consciousness. T 99, BP 100/70. Fully recovered, stood up, walked and discharged. Duration 15 minutes.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Erythema, Swelling
Clinical narrative: Started with redness and swelling, no fever.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pruritus, Tenderness
Clinical narrative: 4-18 Arm developed red, tender 3" L x 2" wide area with hard center.  Looked like a large hive, lasted about 5 days.  On day 3 also became itchy.  4-23 Symptoms started to subside.  4-24 Arm is just pale red, no swelling.
Age: 4.0
Sex: U
Vaccine: DTAP, IPV, MMRV
Symptoms: Swelling
Clinical narrative: Left arm large bump size of golf ball. Per mom applied ice left arm patient received vaccine 4/23/08, came back PPD read 4/25/08.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Redness, induration, warmth surrounding injection site. 5-6cm diameter.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dysphemia, Headache, Hypoaesthesia facial, Induration, Tremor
Clinical narrative: Lt facial numbness, tremors to lt hand, arm, hard. Pain to left side of head. Stutters. Mother evidenced sxs with HPV and MCV4. Has been seen in hospital, neuro clinic. Unknown Dx - possible complex partial seizure/? Psychogenic component.  5/9/08 Reviewed neuro clinic records of 1/29-2/21/08. FINAL DX: stress induced conversion reaction Records reveal patient experienced left sided numbness, left hand twitching which included face & leg intermittently w/periodic vertigo & HA.  Exam found very blunted affect, poor eye contact, slow speech, mild decreased sensation of LUE w/normal strength, tone & reflexes.  By 2/21, tremors had increased & now included stuttering.  Referred for counseling.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Disturbance in attention, Migraine, Musculoskeletal stiffness, Myalgia
Clinical narrative: With anthrax vaccine (4), service member (SM) denies any unusual or prolonged local reactions. He experienced a migraine headache. He describes the headache pain being constant aching pain with occasional sharp pains located at the base of his head and was accompanied by nausea. He had no improvement with OTC headache remedies (Tylenol, ibuprofen, Goody's powder). He had no history of similar headaches. He also had sore joints and muscles with onset within 24 hours of vaccine receipt and resolving within 3 days. After AVA (5), SM denies any unusual or prolonged local reactions. He experienced a "terrible" headache with n/v. Also, his "whole body" was sore (muscle and joints ached all over). These symptoms lasted about 5 days. His headache came and went. In addition to nausea, he also vomited a couple of times. He spoke to an MD on the phone and was told his symptoms were 'normal reaction to AVA.' Had similar symptoms after his 6th anthrax vaccine 'only a little worse' and lasted about a week. He had the same reaction after his next anthrax vaccine (7), but the headache and body aches were 'the worst'. He wondered if that week would ever end. His unit released him from work x 2-3 days. He could not concentrate due to the nausea and pain. Since his last AVA vaccine, he has not experienced any muscle or joint pain, other than r/t overuse. He has had 1-2 headaches since then with one migraine in the fall of 2006. He has had other minor headaches, but not associated with nausea and aching. Other headaches have always gone away with OTC meds. Muscle and joint pain was constant dull aching pain rated as 4-5/10 using pain ascale of 0-10. Treated with OTC analgesics with no significant decrease pain. The only thing that helped was massaging muscle and that provided ltd relief. He had some morning stiffness that took 'awhile to loosen up'. No paresthesias. PAIN: Wrist symptoms, elbow symptoms, arm symptoms, back symptoms, knee symptoms, leg symptoms, ankle symptoms, muscle aches, and arthralgias. No localized joint swelling. Symptomms: Muscle Pain; Symptom: Joint Pain, multiple joints, Headache, Migraine; Nausea w/vomiting
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: With anthrax vaccine (4), service member (SM) denies any unusual or prolonged local reactions. He experienced a migraine headache. He describes the headache pain being constant aching pain with occasional sharp pains located at the base of his head and was accompanied by nausea. He had no improvement with OTC headache remedies (Tylenol, ibuprofen, Goody's powder). He had no history of similar headaches. He also had sore joints and muscles with onset within 24 hours of vaccine receipt and resolving within 3 days. After AVA (5), SM denies any unusual or prolonged local reactions. He experienced a "terrible" headache with n/v. Also, his "whole body" was sore (muscle and joints ached all over). These symptoms lasted about 5 days. His headache came and went. In addition to nausea, he also vomited a couple of times. He spoke to an MD on the phone and was told his symptoms were 'normal reaction to AVA.' Had similar symptoms after his 6th anthrax vaccine 'only a little worse' and lasted about a week. He had the same reaction after his next anthrax vaccine (7), but the headache and body aches were 'the worst'. He wondered if that week would ever end. His unit released him from work x 2-3 days. He could not concentrate due to the nausea and pain. Since his last AVA vaccine, he has not experienced any muscle or joint pain, other than r/t overuse. He has had 1-2 headaches since then with one migraine in the fall of 2006. He has had other minor headaches, but not associated with nausea and aching. Other headaches have always gone away with OTC meds. Muscle and joint pain was constant dull aching pain rated as 4-5/10 using pain ascale of 0-10. Treated with OTC analgesics with no significant decrease pain. The only thing that helped was massaging muscle and that provided ltd relief. He had some morning stiffness that took 'awhile to loosen up'. No paresthesias. PAIN: Wrist symptoms, elbow symptoms, arm symptoms, back symptoms, knee symptoms, leg symptoms, ankle symptoms, muscle aches, and arthralgias. No localized joint swelling. Symptomms: Muscle Pain; Symptom: Joint Pain, multiple joints, Headache, Migraine; Nausea w/vomiting
Age: 18.0
Sex: M
Vaccine: HEP, MMR, TD
Symptoms: Dizziness, Unresponsive to stimuli
Clinical narrative: Immediately follow administration of Td, pt became lightheaded and unresponsive after about 30-60 seconds. He quickly aroused with no sequelae.
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure 9 days after MMR.
Age: 0.6
Sex: M
Vaccine: DTAP, HBHEPB
Symptoms: Dysphagia, Pharyngeal oedema, Pyrexia, Rash, Urticaria
Clinical narrative: Per mother, patient developed temperature of 103 and broke out in rash on face and shoulder which looked like hives in the evening of April 2, after receiving DTaP and HBV/HIB vaccines. He was acting like he had "swollen throat" and could not swallow well. Given Ibuprofen at 10PM, and 11Am the following day. Patient taken to ER at 3PM.
Age: 24.0
Sex: M
Vaccine: TTOX
Symptoms: Confusional state, Dizziness, Fatigue
Clinical narrative: Lightheadness lasting 10 seconds, stated "feel confused, like a high (1 sec) feel tired-Sx for 30 minutes.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Red, hard area at injection site 7cm x 6 cm.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Erythema, Urticaria
Clinical narrative: (L) deltoid has small scattered hives and redness. 2 tsp po Benadryl (12.5 mg/5 ml) given. Pt observed for additional 30 min - hives gone. No s/s of reaction. Pt in stable condition.
Age: 9.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Site of injection is red, swollen (size of 3-4 cm), hard and painful.
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a female pediatric patient who on an unspecified date was vaccinated subcutaneously with a 0.5 ml dose of VARIVAX (Oka/Merck), and subsequently developed a rash. Unspecified medical attention was sought. No further information was provided. There was no product quality complaint. No further information is expected. This is one of several reports from the same source.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Acne, Fatigue, Headache, Varicella
Clinical narrative: Varicella vaccine administered 4/11/08. Patient called 4/22/08 to report little "acne" like bumps in area of vaccination. Noted more bumps on epilateral side of body. Saw dermatologist, who cultured, given diagnosis of chickenpox. Started on Valtrex. Patient called 4/25/08 to report fatigue and headache.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site discolouration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Varivax Local reaction at injection site - approximately 4 cm x 5 cm pink, puffy, warm, pruritic
Age: 61.0
Sex: F
Vaccine: TD
Symptoms: Abdominal pain upper, Cough, Diarrhoea, Dysphonia, Dyspnoea
Clinical narrative: Mild fever, aches, cough, hoarseness, stomach ache, headaches, tired, shortness of breath (but Ihave asthma) diarrhea!!!
Age: 61.0
Sex: F
Vaccine: TD
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Mild fever, aches, cough, hoarseness, stomach ache, headaches, tired, shortness of breath (but Ihave asthma) diarrhea!!!
Age: 54.0
Sex: F
Vaccine: TD
Symptoms: Headache, Injection site erythema, Myalgia
Clinical narrative: Initial report received on 20 March 2007 from a healthcare professional. A 54 year old female patient received on 13 March 2007 a dose of DECAVAC (lot# U1923CA) and three days post vaccination experienced headaches, generalized myalgias-ankles, knees, hips, shoulder and wrist. Seven days post vaccination, the patient experienced redness at injection site. The patient was treated with ZYRTEC 10mg, PREDNISONE and KEFLEX. The patient had not recovered. The patient had a laceration on the right middle finger at vaccination time. Medical history included: gastric bypass (5 years ago), allergies to CIPRO, codeine and morphine. Other medications included: AMBIEN CR 6.25mg, LEXAPRO, ALLEGRA, ZELNORM. Follow-up information was received from a health professional on 16 July 2007. The patient was given 15mg of oral PREDNISONE on 20 March 200 to treat "reaction to TD circumferential around arm". The reporter made several attempts to obtain follow-up, but the patient did not return phone calls.
Age: 48.0
Sex: F
Vaccine: HEPA, TD
Symptoms: Hypoaesthesia, Muscular weakness, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Initial report received on 02 May 2007 from another manufacturer, report number A0645609A. The initial reporter to the other manufacturer was a physician. Verbatim from report: "This case was reported by a physician and described the occurrence of weakness in a 47-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline), diphtheria and tetanus toxoids. On 28 June 2006 the subject received 1st dose of HAVRIX at 0.5 mL in the left arm and a booster dose of Tetanus + diphtheria toxoids (Aventis). Within approximately 7 weeks of vaccination with HAVRIX and Tetanus + diphtheria toxoids, on 13 August 2006, the subject experienced weakness and numbness primarily on the left side in both the upper and lower extremities. At the time, no other cause could be identified for the events other than possible multiple sclerosis. The physician considered the events were disabling. No treatment was required and the events resolved approximately 6 months later on 16 February 2007. In the reporter's opinion, the events were possibly related to treatment with HAVRIX. MRI of the brain and thoracic c-spine were negative." A search of the Sanofi Pasteur product system revealed a lot number for the DECAVAC to be U1731AA. Follow-up information was received from a phone message left by a representative from manufacturer GlaxoSmithKline (GSK) on 17 October 2007. The message indicated that GSK has made multiple attempts to contact the reporter in order to obtain more information. As GSK has not received any response, they consider the case closed. It was also indicated that GSK would forward any additional information they might receive in the future. Relevant Test/Laboratory Data : "MRI of the brain and thoracic c-spine were negative." Medical assessment: The events of weakness and numbness, primarily on the left side in both the upper and lower extremities, were reported in a patient who had received a concurrent immunization with Td and Hepatitis A vaccines, 46 days prior to the symptom onset. Possible multiple sclerosis was initially suspected, but the imaging studies were negative. The documentation of this report is incomplete at this time. The reporter assessed that the events were possibly associated with the hepatitis A vaccine.
Age: 55.0
Sex: F
Vaccine: TD
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site warmth, Muscular weakness
Clinical narrative: Initial report received on 05 October 2007 from a health care professional. A 56-year-old female patient had received an injection of Diphtheria and Tetanus vaccine, manufacturer not reported, lot number not reported, and route and site of administration not reported, on 24 July 2007. Two days post-vaccination, the patient developed severe pain and weakness in the right arm where she had received the vaccination. The weakness was so severe that she had difficulty picking up light objects. She also had a fever of 101 degrees Fahrenheit. The patient did not seek medical attention. Relevant diagnostic testing was none. She improved over a four day period and recovered from the event. There were no long term adverse effects. Follow-up information was received from the health professional on 16 November 2007. The patient received a right deltoid injection of DECAVAC (lot number U1953B) on 24 July 2007. Within 12 hours of vaccination (previously reported as two days), the patient began experiencing pain in the right arm. Over the next two days, her pain became severe, and movement of th right arm became limited. In addition, she experienced warmth and redness at the injection site. She denied illness at the time of vaccination. Per the reporter, "this client said she does not like to go to doctors unless she absolutely has to which is why she did not seek medical attention". The reporter in this case is the same as in case 2007-03404.
Age: 55.0
Sex: F
Vaccine: TD
Symptoms: Pyrexia
Clinical narrative: Initial report received on 05 October 2007 from a health care professional. A 56-year-old female patient had received an injection of Diphtheria and Tetanus vaccine, manufacturer not reported, lot number not reported, and route and site of administration not reported, on 24 July 2007. Two days post-vaccination, the patient developed severe pain and weakness in the right arm where she had received the vaccination. The weakness was so severe that she had difficulty picking up light objects. She also had a fever of 101 degrees Fahrenheit. The patient did not seek medical attention. Relevant diagnostic testing was none. She improved over a four day period and recovered from the event. There were no long term adverse effects. Follow-up information was received from the health professional on 16 November 2007. The patient received a right deltoid injection of DECAVAC (lot number U1953B) on 24 July 2007. Within 12 hours of vaccination (previously reported as two days), the patient began experiencing pain in the right arm. Over the next two days, her pain became severe, and movement of th right arm became limited. In addition, she experienced warmth and redness at the injection site. She denied illness at the time of vaccination. Per the reporter, "this client said she does not like to go to doctors unless she absolutely has to which is why she did not seek medical attention". The reporter in this case is the same as in case 2007-03404.
Age: 55.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site pustule, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received on 05 October 2007 from a health care professional. A 55-year-old female patient, with no known illness at the time of vaccination, had received a first dose, left arm, intramuscular injection of DECAVAC, lot number U1953BA, on 13 August 2007. Two days post-vaccination, she was examined in a health unit and was experiencing erythema, edema, and local heat of the left deltoid as well as a headache. The following day, the erythema, edema, and heat extended an unspecified distance from the deltoid area, and a pustule was present at the injection site. She was referred to a physician but did not go. The next day, she returned to the clinic and indicated that she had experienced a fever of "at least" 101 degrees Fahrenheit for three days following vaccination (initial) onset date of symptoms in the structured field of this report was 14 August 2007). The patient was subsequently examined by a physician and treated with antibiotic and anti-inflammatory medication. During the event, she had good mobility in the arm and continued to work. At the time of this report, the patient had recovered. Follow-up information was received from the health professional on 16 November 2007. The patient's fever pain, swelling, redness, and warmth at the injection site all developed on 14 August 2007. The reporter did not know the names of the treatment medications. The reporter in this case is the same as in case 2007-03405.
Age: 55.0
Sex: F
Vaccine: TD
Symptoms: Pyrexia
Clinical narrative: Initial report received on 05 October 2007 from a health care professional. A 55-year-old female patient, with no known illness at the time of vaccination, had received a first dose, left arm, intramuscular injection of DECAVAC, lot number U1953BA, on 13 August 2007. Two days post-vaccination, she was examined in a health unit and was experiencing erythema, edema, and local heat of the left deltoid as well as a headache. The following day, the erythema, edema, and heat extended an unspecified distance from the deltoid area, and a pustule was present at the injection site. She was referred to a physician but did not go. The next day, she returned to the clinic and indicated that she had experienced a fever of "at least" 101 degrees Fahrenheit for three days following vaccination (initial) onset date of symptoms in the structured field of this report was 14 August 2007). The patient was subsequently examined by a physician and treated with antibiotic and anti-inflammatory medication. During the event, she had good mobility in the arm and continued to work. At the time of this report, the patient had recovered. Follow-up information was received from the health professional on 16 November 2007. The patient's fever pain, swelling, redness, and warmth at the injection site all developed on 14 August 2007. The reporter did not know the names of the treatment medications. The reporter in this case is the same as in case 2007-03405.
Age: 60.0
Sex: F
Vaccine: TD
Symptoms: Glossodynia, Swollen tongue
Clinical narrative: Initial report received on 12 October 2007 from a health care professional. A 60-year-old female patient, who had recently stepped on a nail, had received a right gluteal, intramuscular injection of DECAVAC, lot number U1820GA, on 08 October 2007. The next day, the patient developed a swollen tongue and soreness under the left side of her tongue. She experienced no shortness of breath or wheezing, and her speech was clear. The following day, she was examined in an emergency room and treated with intravenous BENADRYL and "intravenous" epinephrine. The patient also took oral BENADRYL daily. Per the reporter, the soreness and some swelling persists. At the time of this report, the patient had not recovered. Follow-up information received on 10 December 2007 from a health care professional. Per the reporter, the patient is not one of their patient's and all correspondence needs to go to the patient's primary care physician. The contact information was provided for the primary care physician. No relevant medically significant information was added to the case. Follow-up information received 25 January 2008 from a health care professional. According to the reporter, the patient was only seen by the primary care physician one time on 10 October 2007 for a follow-up visit due to the adverse experience on 09 October 2007. The primary care physician prescribed BENADRYL and the patient was instructed to follow-up as needed. No further information was provided.