chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Loss of consciousness
Clinical narrative: Severe stomach ache, diarrhea, headache,dizziness,coldness, and loss of consciousness.  After passing out I fell and hurt my face and pump my head.  For a few hours I was dizzy.  The rest of the day I was tired,but all symptoms were gone. The site were the vaccine was administered got swollen and red. Today look fine.  Did not call my doctor because I started feeling better and I don't seem to have any adverse damage.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, MMRV
Symptoms: Injection site induration, Injection site swelling, Skin exfoliation, Tenderness
Clinical narrative: Area of induration and swelling 8cm X 12cm left thigh. Indurated and tender, but no fluctuance. Peeling of skin over surface.
Age: 1.08
Sex: M
Vaccine: HBHEPB, HEPA, MMRV, PNC
Symptoms: Pyrexia
Clinical narrative: Developed fever evening of shots.  7pm  fever 103. Tylenol.
Sex: M
Vaccine: HEP
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: 4/30/07 @ 1400 "getting wound up and experiencing a lot of stress and experiencing chest d/c. Then after shot chest d/c and dull ache in L arm.  Dull ache in front of the cheston L. Soreness in arm around injection site upper and lower arm." 5/2/07 @1040 "States just soreness around injection site"
Age: 19.0
Sex: F
Vaccine: DTAP
Symptoms: Body temperature increased, Injection site erythema, Oedema peripheral, Pain in extremity
Clinical narrative: INJ GIVEN 04/25/07 AT HEALTH DEPT., NO REDNESS OR SWELLING FOR 3 DAYS, SEEN IN OUR OFFICE ON 5/1/07 RT ARM RED AND SLIGHTLY SWOLLEN FROM ELBOW TO FINGERS, SLIGHT REDNESS AT INJECTION SITE. PT STATES VERY PAINFUL. TEMP ON 5/1/07 100.2 ORALLY. INSTRUCTED TO TAKE TYLENOL FOR PAIN, ICE ARM AND REST IT UNTIL BETTER.
Age: 48.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Body temperature increased, Chills, Dizziness, Headache, Nausea
Clinical narrative: Within 24 hours, headache, achiness, chills, pale, dizzy, T-103, achiness increasingly severe, nausea. By 48 hours, temp decreased to 101 and feeling 50% better.
Age: 48.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Pain, Pallor
Clinical narrative: Within 24 hours, headache, achiness, chills, pale, dizzy, T-103, achiness increasingly severe, nausea. By 48 hours, temp decreased to 101 and feeling 50% better.
Age: 48.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Body temperature increased, Computerised tomogram normal, Headache, Injection site pain, Laboratory test
Clinical narrative: Within 24 hours, headache, achiness, chills, pale, dizzy, T-103, achiness increasingly severe, nausea. By 48 hours, temp decreased to 101 and feeling 50% better.
Age: 48.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Lumbar puncture normal, Malaise, Nausea, Pain
Clinical narrative: Within 24 hours, headache, achiness, chills, pale, dizzy, T-103, achiness increasingly severe, nausea. By 48 hours, temp decreased to 101 and feeling 50% better.
Age: 48.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Blood electrolytes normal, Body temperature increased, Computerised tomogram normal, Full blood count normal, Headache
Clinical narrative: Within 24 hours, headache, achiness, chills, pale, dizzy, T-103, achiness increasingly severe, nausea. By 48 hours, temp decreased to 101 and feeling 50% better.
Age: 48.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Kernig's sign, Laboratory test normal, Lumbar puncture normal, Malaise, Musculoskeletal stiffness
Clinical narrative: Within 24 hours, headache, achiness, chills, pale, dizzy, T-103, achiness increasingly severe, nausea. By 48 hours, temp decreased to 101 and feeling 50% better.
Age: 48.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Nausea
Clinical narrative: Within 24 hours, headache, achiness, chills, pale, dizzy, T-103, achiness increasingly severe, nausea. By 48 hours, temp decreased to 101 and feeling 50% better.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Injection site swelling, Local reaction
Clinical narrative: ATYPICAL LOCAL REACTION  SWELLING OF THIGH
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Abasia, Abdominal pain upper, Abnormal behaviour, Aggression, Body temperature increased
Clinical narrative: Approximately 1 hour after vaccinations she began to have stomach cramps, headache, and was tired. For the next 5 hours her tiredness increased and her cramping became more pronounced. At about 3:30P.M. her behavior changed and she wobbled between tiredness and aggression, she was not acting her normal self. This persisted for about an hour and she finally went to bed about 6:00P.M. She awoke crying about her stomach at 8:30P.M., 10:00P.M., 12:15P.M., and 3:30 A.M.  At 3:30 she said her legs, arms, neck, head, and stomach hurt. At this time she had wet the bed, which is unusual for her. She would scream if I touched her right arm. She needed to vomit so I tried to get her up and she said she couldn't walk. I carried her to the bathroom where she vomited repeatedly. Her temperature was 103.2F. I gave her a cool bath at 5:00A.M. which brought the fever down. She vomited  again at 6:00A.M. and 6:25A.M. At about 7:45A.M. she started to feel better. Currently it is 9:45A.M and she still has a pain in her stomach, but her other pains have dissipated, and she has not vomited again. I called her doctor at 9:05A.M. and was told the incident is unrelated and she must have the flu, I needed to give her Pedialyte and they would call back later. I have filled this form out to the best of my knowledge. Three shots were given in her right, upper arm and two in her left, upper arm.  I guessed that they were intradermal, all other information will have to come from the doctor's office.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Crying, Enuresis, Fatigue, Headache, Screaming
Clinical narrative: Approximately 1 hour after vaccinations she began to have stomach cramps, headache, and was tired. For the next 5 hours her tiredness increased and her cramping became more pronounced. At about 3:30P.M. her behavior changed and she wobbled between tiredness and aggression, she was not acting her normal self. This persisted for about an hour and she finally went to bed about 6:00P.M. She awoke crying about her stomach at 8:30P.M., 10:00P.M., 12:15P.M., and 3:30 A.M.  At 3:30 she said her legs, arms, neck, head, and stomach hurt. At this time she had wet the bed, which is unusual for her. She would scream if I touched her right arm. She needed to vomit so I tried to get her up and she said she couldn't walk. I carried her to the bathroom where she vomited repeatedly. Her temperature was 103.2F. I gave her a cool bath at 5:00A.M. which brought the fever down. She vomited  again at 6:00A.M. and 6:25A.M. At about 7:45A.M. she started to feel better. Currently it is 9:45A.M and she still has a pain in her stomach, but her other pains have dissipated, and she has not vomited again. I called her doctor at 9:05A.M. and was told the incident is unrelated and she must have the flu, I needed to give her Pedialyte and they would call back later. I have filled this form out to the best of my knowledge. Three shots were given in her right, upper arm and two in her left, upper arm.  I guessed that they were intradermal, all other information will have to come from the doctor's office.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Vomiting
Clinical narrative: Approximately 1 hour after vaccinations she began to have stomach cramps, headache, and was tired. For the next 5 hours her tiredness increased and her cramping became more pronounced. At about 3:30P.M. her behavior changed and she wobbled between tiredness and aggression, she was not acting her normal self. This persisted for about an hour and she finally went to bed about 6:00P.M. She awoke crying about her stomach at 8:30P.M., 10:00P.M., 12:15P.M., and 3:30 A.M.  At 3:30 she said her legs, arms, neck, head, and stomach hurt. At this time she had wet the bed, which is unusual for her. She would scream if I touched her right arm. She needed to vomit so I tried to get her up and she said she couldn't walk. I carried her to the bathroom where she vomited repeatedly. Her temperature was 103.2F. I gave her a cool bath at 5:00A.M. which brought the fever down. She vomited  again at 6:00A.M. and 6:25A.M. At about 7:45A.M. she started to feel better. Currently it is 9:45A.M and she still has a pain in her stomach, but her other pains have dissipated, and she has not vomited again. I called her doctor at 9:05A.M. and was told the incident is unrelated and she must have the flu, I needed to give her Pedialyte and they would call back later. I have filled this form out to the best of my knowledge. Three shots were given in her right, upper arm and two in her left, upper arm.  I guessed that they were intradermal, all other information will have to come from the doctor's office.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Chest X-ray normal, Chest pain, Electrocardiogram normal, Injection site pain
Clinical narrative: Chest pain for 4 days which started 5 days after gardasil administration.  Also has injection site pain.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Skin warm, Tenderness
Clinical narrative: Patient's left arm became red, warm and swollen beginning the day of injection in the afternoon. One the second day  she felt like the flu.  Today she still has an area of erythema and tenderness of about 4cm by 5 cm distal the injection site without swelling, erythema or warmth.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral
Clinical narrative: LEFT ARM SWOLLEN AND RED
Age: 27.0
Sex: M
Vaccine: TYP
Symptoms: Myelitis transverse
Clinical narrative: PT DEVELOPED CERVICAL TRANSVERSE MYELITIS 7 DAYS AFTER VACCINATION
Age: 32.0
Sex: F
Vaccine: TYP
Symptoms: Arthralgia, Diarrhoea, Flushing, Nausea
Clinical narrative: Presented post two doses of oral typhoid. 128/90 76 18 98.7States she has had flushing, intemittent diarrhea, nausea and joint pain. Has not noticed and blood in stool. Instructed to discontinue the rest of the tablets.
Age: 45.0
Sex: M
Vaccine: TYP
Symptoms: Rash, Urticaria
Clinical narrative: HIVES TYPE RASH - L ARM THEN R ARM - OVER THE BACK BUTTOCKS AND BACK OF BOTH LEGS.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, PNC, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient was brought in by her mother and father. Reported redness and size of a 50 cent piece with swelling, mild pain. The area was hot to touch with a dime size knot in the middle approximately 30 hours after the injection. This occured on the right arm, the site whre the prevnar was given IM. Is currently still taking tylenol for symptoms. The nurse encouraged warm compresses to the area and benedryl . To return to the PMD or NCHD if symptoms persist or worsen.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception
Clinical narrative: April 24, 2007 patient was treated for intersusseption records received 5/15/07-intussusception. exploratory laparotomy.
Age: 77.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration, Medication error
Clinical narrative: None  Adacel was given to patient who was too old according to the guidelines
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Culture throat negative, Dizziness, Headache, Influenza
Clinical narrative: At 2:00am on 4/26/07 patient woke up with a severe sore throat. She experienced chills and pain in lower extremities(legs). She did not take temp so unsure if she had fever. When she woke up later in am she felt like she had the flu. She experienced dizziness, headache and weakness in her legs. Called Dr. on 4/28/07 because she was not getting any better. Dr. could not see her that day so patient made an appointment for Mon 4/30/07. At that point in time, still had some weakness in her legs and patient still felt very bad. Dr. proceeded to do a strep culture on her. The strep culture came back negitive. Patient still complaining of slight headache as of today,but most of the other symptoms have subsided. Patients denies of ever having symptoms like this prior to a vaccination. Patient states that in 2003 she was given a Tetnus-Diptheria only, and the only side effect she had was a sore arm.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Muscular weakness, Pain in extremity, Pharyngolaryngeal pain
Clinical narrative: At 2:00am on 4/26/07 patient woke up with a severe sore throat. She experienced chills and pain in lower extremities(legs). She did not take temp so unsure if she had fever. When she woke up later in am she felt like she had the flu. She experienced dizziness, headache and weakness in her legs. Called Dr. on 4/28/07 because she was not getting any better. Dr. could not see her that day so patient made an appointment for Mon 4/30/07. At that point in time, still had some weakness in her legs and patient still felt very bad. Dr. proceeded to do a strep culture on her. The strep culture came back negitive. Patient still complaining of slight headache as of today,but most of the other symptoms have subsided. Patients denies of ever having symptoms like this prior to a vaccination. Patient states that in 2003 she was given a Tetnus-Diptheria only, and the only side effect she had was a sore arm.
Age: 11.0
Sex: M
Vaccine: IPV, MNQ, TDAP
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: Localized redness, swelling, and tenderness in right arm.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Grand mal convulsion, Nuclear magnetic resonance imaging brain normal, Partial seizures, Scan brain
Clinical narrative: 16 year old s/p receiving HPV #2 on 4/6/07. Presented 4/9/07 with possible focal seizure (contracture right hand) sent to ER then admitted with Grand Mal seizure episode that evening. Patient placed on Dilantin discharged home on Dilantin PO. No FMH of seizure episodes. 06/06/07-records received for DOS 4/10-4/11/07-DC DX:Seizures Partial complex. Intermittent periods of right hand pain and shaking. Subsequent period of shaking episode of right hand progressed to generalized tonic clonic shaking of arms and legs associated with loss of consciousness and post ictal period. Received HPV vaccine 3 days before.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Night sweats
Clinical narrative: "Sweats thru night of injection "per mother, arm swollen and red deltoid within 24 hours - persisting greater than 48 hours. Using Tylenol/ Motrin - patient declined cold/ hot packs to arm. Positive mobility/normal temp and color of hand and fingers.
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Antinuclear antibody negative, Arthralgia, Fatigue, Full blood count normal, Rash
Clinical narrative: 4/12/07 Generalized arthralgia, myalgia, rash noted on lower extremities, fatigue. 4/23/07 Symptoms begin to decrease 5/2/07 rash gone, myalgia/arthralgia gone - some fatigue and endurance remains.
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Red blood cell sedimentation rate normal
Clinical narrative: 4/12/07 Generalized arthralgia, myalgia, rash noted on lower extremities, fatigue. 4/23/07 Symptoms begin to decrease 5/2/07 rash gone, myalgia/arthralgia gone - some fatigue and endurance remains.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Erythema, Induration, Local reaction
Clinical narrative: Local reaction (redness, induration of left thigh) approximately 24 hours after vaccine was administered.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Induration, Local reaction
Clinical narrative: Local reaction (redness, induration) in both right and left thigh areas that began approximately 24 hours  after immunizations were given. Treatment: warm compress, Ibuprofen, hydrocortisone cream.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Rash pruritic
Clinical narrative: Rash/Puritic <24 hr
Age: 1.3
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Insomnia, Irritability, Rash, Rash papular
Clinical narrative: Received MMRV on 4/20/07. Patient irritable, decrease sleep began 1/27/07 intensified over the next few days. Rash erupted 5/?/07. Small red papules on trunk/ back, few on face, no fever.
Age: 1.3
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Insomnia, Irritability, Pyrexia, Rash erythematous, Rash papular
Clinical narrative: Received MMRV on 4/20/07. Patient irritable, decrease sleep began 1/27/07 intensified over the next few days. Rash erupted 5/?/07. Small red papules on trunk/ back, few on face, no fever.
Age: 1.3
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Diarrhoea, Immunisation reaction, Irritability, Pyrexia, Rash
Clinical narrative: Rec'd ProQuad - MMR-V 4/23/07 (MMRV reaction) rash and fever Maculopapular rash on neck and back, cranky but consolable. Also had fever and diarrhea. Information has been received from a licensed graduate practical nurse concerning a 15-month-old male who on 23-APR-2007 was vaccinated with a first dose of PROQUAD. On 02-MAY-2007 the patient vomited once. This patient was seen in the office on 02-May-2007 with a maculopapular rash on his neck and back, he was cranky but consolable, and had a fever and diarrhea that lasted fo r3 days. The reporter felt that diarrhea, fever, cracky, maculopapular rash on neck and back and vomited were related to therapy with PROQUAD. On an unspecified date the patient recovered. This is one of several reports from the same reporter.
Age: 1.3
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Rash maculo-papular, Vomiting
Clinical narrative: Rec'd ProQuad - MMR-V 4/23/07 (MMRV reaction) rash and fever Maculopapular rash on neck and back, cranky but consolable. Also had fever and diarrhea. Information has been received from a licensed graduate practical nurse concerning a 15-month-old male who on 23-APR-2007 was vaccinated with a first dose of PROQUAD. On 02-MAY-2007 the patient vomited once. This patient was seen in the office on 02-May-2007 with a maculopapular rash on his neck and back, he was cranky but consolable, and had a fever and diarrhea that lasted fo r3 days. The reporter felt that diarrhea, fever, cracky, maculopapular rash on neck and back and vomited were related to therapy with PROQUAD. On an unspecified date the patient recovered. This is one of several reports from the same reporter.
Age: 1.3
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Diarrhoea, Irritability, Pyrexia, Rash maculo-papular, Vomiting
Clinical narrative: Rec'd ProQuad - MMR-V 4/23/07 (MMRV reaction) rash and fever Maculopapular rash on neck and back, cranky but consolable. Also had fever and diarrhea. Information has been received from a licensed graduate practical nurse concerning a 15-month-old male who on 23-APR-2007 was vaccinated with a first dose of PROQUAD. On 02-MAY-2007 the patient vomited once. This patient was seen in the office on 02-May-2007 with a maculopapular rash on his neck and back, he was cranky but consolable, and had a fever and diarrhea that lasted fo r3 days. The reporter felt that diarrhea, fever, cracky, maculopapular rash on neck and back and vomited were related to therapy with PROQUAD. On an unspecified date the patient recovered. This is one of several reports from the same reporter.
Age: 4.0
Sex: F
Vaccine: IPV, MMRV
Symptoms: Erythema
Clinical narrative: Benadryl TID. RTC if redness increase, pain or fever.
Age: 10.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Blood pressure, Heart rate normal, Nausea, Oxygen saturation normal, Pallor
Clinical narrative: After vaccine given patient felt weak and nauseated. She had pale skin. HR 84, BP 94/60, O2 Sat 94%, resp even and unlabored after lying down for 20 minutes patient felt better she was still alot nauseated and her stomach hurt but she wanted to return to school.
Age: 10.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Stomach discomfort
Clinical narrative: After vaccine given patient felt weak and nauseated. She had pale skin. HR 84, BP 94/60, O2 Sat 94%, resp even and unlabored after lying down for 20 minutes patient felt better she was still alot nauseated and her stomach hurt but she wanted to return to school.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red swollen R leg within 4 hrs of injection
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Heat therapy, Injection site erythema, Injection site induration
Clinical narrative: Local reaction (redness, induration) L thigh that began approximately 24 hours after injection. Treatment: warm compresses, Ibuprofen
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Crying
Clinical narrative: He cried for 7 hours after receiving Dtap at 2 months/ shots visit.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Generalized erythema warm to touch, minimally tender, (+) firmness in area approximately 2" x 2 1/2".
Age: 4.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Cold compress therapy, Injection site erythema, Injection site pain
Clinical narrative: Vaccine given at 4/30/07 in PM. On 5/1/07 approximately 5 pm child C/o pain and erythema at injection site (R) Triceps area discussed Tylenol for discomfort Ice pack monitor area and return in 2 days PRN Child returning in 2 days.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling, warm to touch
Age: 24.0
Sex: F
Vaccine: ANTH
Symptoms: Drug exposure during pregnancy, Foetal disorder, Immune system disorder
Clinical narrative: May 2006 filed a complaint concerning child who is now 3 years old. Was administered the Anthrax shot in my first trimester of pregnancy, had two shots. Child born from pregnancy has a severely weak immune system and other complications received emails from someone but no other response.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Information has been received from a physician concerning an 18 year old female patient who on 29-JAN-2007 was vaccinated in her left arm with her first dose of Gardasil, lot #655617/1447F. Concomitant therapy included meningococcal vaccine (unspecified). On 29-JAN-2007 after receiving the injection the patient experienced weakness and tingling in her left arm which spread over the entire length of her arm and also to her jaw. She experienced so much discomfort in her jaw that she had difficulty chewing. An examination of the patient ruled out Guillain-Barre Syndrome. The above reaction eventually resolved in two weeks and on approximately 12-FEB-2007, the patient recovered. The physician considered the events to be disabling. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Muscular weakness, Paraesthesia
Clinical narrative: Information has been received from a physician concerning an 18 year old female patient who on 29-JAN-2007 was vaccinated in her left arm with her first dose of Gardasil, lot #655617/1447F. Concomitant therapy included meningococcal vaccine (unspecified). On 29-JAN-2007 after receiving the injection the patient experienced weakness and tingling in her left arm which spread over the entire length of her arm and also to her jaw. She experienced so much discomfort in her jaw that she had difficulty chewing. An examination of the patient ruled out Guillain-Barre Syndrome. The above reaction eventually resolved in two weeks and on approximately 12-FEB-2007, the patient recovered. The physician considered the events to be disabling. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: MNQ, PPV, MNQ, PPV, MNQ, PPV
Symptoms: Abscess drainage, Culture positive, Inappropriate schedule of drug administration, Staphylococcus test positive, Swelling
Clinical narrative: Information has been received from a physician concerning a 17 year old Hispanic male with chronic respiratory failure (oxygen dependent), chronic swelling along scar tissue on the upper back, severe kyphoscoliosis and klippe,-feil syndrome and a history of multiple back surgeries, cleft palate repair, atrial septal defect repair (1995) and craniotomy (1994) who on 22-FEB-2007 was vaccinated, intramuscularly into the right deltoid, with a 3 ml first dose of Pneumovax 23 (lot #655289/0958F) concomitantly with a first dose of Menactra (lot # U2208AA) intramuscularly into the left deltoid. Other concomitant therapy included, budesonide (PULMICORT) and albuterol. On 02-MAR-2007, one of two chronic abcess on scar tissue on the upper back ruptured and drained pus and blood. On 05-MAR-2007, culture of the back abcess revealed scant growth of staphylococcus aureus sensitive to ciprofloxacin hydrochloride (CIPRO), amoxicillin (+) clavulanate potassium, cefazolin, clindamycin, oxacillin sodium, etc. On 05-MAR-2007, therapy with ciprofloxacin hydrochloride (CIPRO) 500 mg BID for 6 weeks was initiated. On 16-MAR-2007, the second chronic abcess on scar tissue on the upper back started draining. At the time of the report, the patient had not recovered. The reporting physician considered chronic abcess on scar tissue on upper back ruptured and second abcess started draining to be other important medical events. No further information is available.
Age: 17.0
Sex: M
Vaccine: MNQ, PPV, MNQ, PPV, MNQ, PPV
Symptoms: Abscess drainage, Abscess rupture, Culture positive, Incorrect dose administered, Staphylococcal abscess
Clinical narrative: Information has been received from a physician concerning a 17 year old Hispanic male with chronic respiratory failure (oxygen dependent), chronic swelling along scar tissue on the upper back, severe kyphoscoliosis and klippe,-feil syndrome and a history of multiple back surgeries, cleft palate repair, atrial septal defect repair (1995) and craniotomy (1994) who on 22-FEB-2007 was vaccinated, intramuscularly into the right deltoid, with a 3 ml first dose of Pneumovax 23 (lot #655289/0958F) concomitantly with a first dose of Menactra (lot # U2208AA) intramuscularly into the left deltoid. Other concomitant therapy included, budesonide (PULMICORT) and albuterol. On 02-MAR-2007, one of two chronic abcess on scar tissue on the upper back ruptured and drained pus and blood. On 05-MAR-2007, culture of the back abcess revealed scant growth of staphylococcus aureus sensitive to ciprofloxacin hydrochloride (CIPRO), amoxicillin (+) clavulanate potassium, cefazolin, clindamycin, oxacillin sodium, etc. On 05-MAR-2007, therapy with ciprofloxacin hydrochloride (CIPRO) 500 mg BID for 6 weeks was initiated. On 16-MAR-2007, the second chronic abcess on scar tissue on the upper back started draining. At the time of the report, the patient had not recovered. The reporting physician considered chronic abcess on scar tissue on upper back ruptured and second abcess started draining to be other important medical events. No further information is available.
Age: 17.0
Sex: M
Vaccine: MNQ, PPV, MNQ, PPV, MNQ, PPV
Symptoms: Abscess drainage, Abscess rupture, Culture positive, Culture wound positive, Staphylococcal abscess
Clinical narrative: Information has been received from a physician concerning a 17 year old Hispanic male with chronic respiratory failure (oxygen dependent), chronic swelling along scar tissue on the upper back, severe kyphoscoliosis and klippe,-feil syndrome and a history of multiple back surgeries, cleft palate repair, atrial septal defect repair (1995) and craniotomy (1994) who on 22-FEB-2007 was vaccinated, intramuscularly into the right deltoid, with a 3 ml first dose of Pneumovax 23 (lot #655289/0958F) concomitantly with a first dose of Menactra (lot # U2208AA) intramuscularly into the left deltoid. Other concomitant therapy included, budesonide (PULMICORT) and albuterol. On 02-MAR-2007, one of two chronic abcess on scar tissue on the upper back ruptured and drained pus and blood. On 05-MAR-2007, culture of the back abcess revealed scant growth of staphylococcus aureus sensitive to ciprofloxacin hydrochloride (CIPRO), amoxicillin (+) clavulanate potassium, cefazolin, clindamycin, oxacillin sodium, etc. On 05-MAR-2007, therapy with ciprofloxacin hydrochloride (CIPRO) 500 mg BID for 6 weeks was initiated. On 16-MAR-2007, the second chronic abcess on scar tissue on the upper back started draining. At the time of the report, the patient had not recovered. The reporting physician considered chronic abcess on scar tissue on upper back ruptured and second abcess started draining to be other important medical events. No further information is available.
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Granuloma annulare
Clinical narrative: Received vaccinatin is right arm and three weeks later a granuloma annulare lesion appeared on the same arm.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Injection site streaking, Malaise, Rash, Skin warm
Clinical narrative: Hx of increased redness, warmth, "streaks", felt bad night of injection, vomited once, rash.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Vomiting
Clinical narrative: Hx of increased redness, warmth, "streaks", felt bad night of injection, vomited once, rash.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Death
Clinical narrative: Baby received 5 shots and died the next day of unknown cause - pending coroner report.  6/8/07 Received Autopsy Report which reveals COD as SIDS.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 75 year old female patient with osteoporosis and a history of ovarian cancer who on 11-APR-2007 was vaccinated with Zostavax, subcutaneously. There was no concomitant medication. On 13-APR-2007 the patient experienced cellulitis with redness and swelling at injection site and shingles lesions, located left of midline, in the area of T-12 to L-1. She went to the local ER on 14-APR-2007, and was placed on acyclovir, KEFLEX, and LORTAB, then was released. A follow-up visit with her physician had the patient showing improvement of all symptoms. It was reported that the patient had intervention to prevent serious criteria (other important medical event). There was no product quality complaint involved. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 9 year old female with no medical history or allergies who on 24-APR-2007 was vaccinated SC in left arm with 0.5 ml dose of Varivax (lot # 656688/0124U). There were no concomitant medications. On 24-APR-2007 the patient developed swelling at injection site. On the evening of 25-APR-2007 the patient's symptoms worsened. The patient developed 2 x 3 inch erythematous, warm, slightly tender, clearly demarcated inflammation reaction at injection site on left arm and had body temperature of 99.2 F. The patient was prescribed ice on the left arm at the site of redness for 10 minutes three times a day for 2-3 days. The patient was also prescribed ibuprofen 300 mg by mouth three times a day for 2.3 days. No diagnostic laboratory tests were performed. A product quality complaint was not involved. The 2 x 3 inch erythematous, warm, slightly tender demarcated inflammation reaction was considered to be other important medical events by the reporter. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site warmth
Clinical narrative: Information has been received from a nurse concerning a 9 year old female with no medical history or allergies who on 24-APR-2007 was vaccinated SC in left arm with 0.5 ml dose of Varivax (lot # 656688/0124U). There were no concomitant medications. On 24-APR-2007 the patient developed swelling at injection site. On the evening of 25-APR-2007 the patient's symptoms worsened. The patient developed 2 x 3 inch erythematous, warm, slightly tender, clearly demarcated inflammation reaction at injection site on left arm and had body temperature of 99.2 F. The patient was prescribed ice on the left arm at the site of redness for 10 minutes three times a day for 2-3 days. The patient was also prescribed ibuprofen 300 mg by mouth three times a day for 2.3 days. No diagnostic laboratory tests were performed. A product quality complaint was not involved. The 2 x 3 inch erythematous, warm, slightly tender demarcated inflammation reaction was considered to be other important medical events by the reporter. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness
Clinical narrative: Information has been received from a physician concerning a 16 year old female (also reported as 18 year old ) who on 16-APR-2007 was vaccinated with a dose of GARDASIL. Since 1 day post-injection, the patient had progressive bilateral leg numbness and weakness and motor weakness. The physician inquired about the possibility of Guillian Barre Syndrome. At the time of this report, the outcome was unknown. Upon internal review, progressive bilateral leg numbness and weakness and motor weakness were considered to be other important medical events. No further information is available.
Age: 35.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Injected limb mobility decreased, Insomnia, Musculoskeletal pain
Clinical narrative: Information has been received from a registered nurse concerning a 35 year old female with a history of papilloma viral infection who on unspecified dated, was vaccinated with the first and second dose of Gardasil. 04-APR-2007, the patient was vaccinated with a third dose of Gardasil (lot # 654702/0011U) 0.5 ml IM into the left deltoid. Concomitant therapy included ORTHO TRI-CYCLEN, and ALLEGRA-D. On 05-APR-2007, the patient sought medical attention by contacting the physician's office. The patient reported that on 04-APR-2007, immediately after being vaccinated with the third dose of vaccine, she noticed symptoms. She had severe shoulder pain. The patient could not lift her arm laterally and could not sleep due to the pain. The patient was ordered MEDROL DOSE PACK, heat, and LORCET PLUS. The patient had also been seen at an orthopedics office. She was given 2 steroid injections and she is being set up for physical therapy. The patient did not have any symptoms with the first two doses of vaccine. At the time of reporting, the patient had not recovered. No further information was available at the time of reporting. The reporter felt that the events were disabling. Additional information has been requested.
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with the first dose of Gardasil, injection. Concomitant therapy included MENACTRA. Subsequently on an unspecified date, the patient "passed out" 15 minutes after receiving Gardasil. The patient was sent to the hospital but the length of stay was unknown. Subsequently on an unspecified date, the patient recovered from the event. Additional information has been requested.
Age: 0.6
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, RV5, RV5
Symptoms: Intussusception, Screaming, Sleep disorder, Vomiting
Clinical narrative: Intussusception, increased screaming, vomit, deep sleep.  5/4/07 Received vax records from PCP which reveal the following also received on 4/21/07: DTaP C2552AA 3rd dose Hib UE981AA 3rd dose IPV 20547 3rd dose PCV B086820 3rd dose Rotavirus 0389F 3rd dose 6/19/07 Received ER records.  No D/C Summary available.  Patient seen only in ER on 4/30/07 for vomiting & increased sleepiness. FINAL DX: Intussusception, reduced by air contrast enema.
Age: 0.6
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, RV5, RV5
Symptoms: Intussusception
Clinical narrative: Intussusception, increased screaming, vomit, deep sleep.  5/4/07 Received vax records from PCP which reveal the following also received on 4/21/07: DTaP C2552AA 3rd dose Hib UE981AA 3rd dose IPV 20547 3rd dose PCV B086820 3rd dose Rotavirus 0389F 3rd dose 6/19/07 Received ER records.  No D/C Summary available.  Patient seen only in ER on 4/30/07 for vomiting & increased sleepiness. FINAL DX: Intussusception, reduced by air contrast enema.
Age: 0.1
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Cyanosis, Gastrooesophageal reflux disease, Musculoskeletal stiffness, Respiratory arrest, X-ray with contrast upper gastrointestinal tract
Clinical narrative: Approximately 2 hours after vaccines were administered, patient was drinking 2 oz Neosure formula. Then while burping patient, mom noted stiffening of upper and lower extremities, with milk coming out of nose and mouth. (+) Facial cyanosis, not breathing. Mom gave CPR.  Patient revived after approximately 5 minutes. 06/06/07-records received for DOS 4/25-4/26/07. DC DX: Premature infant presently at 38 weeks gestational age, premature at 32 1/2 weeks. Acute life threatening event possible from vaccine reaction. Gastroesophageal reflux. Two to three hours after vaccines noted to have stiffening of body specifically upper extremities and lower extremities with milk coming our of nose and mouth. Some facial cyanosis and no respirations. Apnea lasted about 5 minutes.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: C-reactive protein increased, Echocardiogram abnormal, Immunoglobulins, Kawasaki's disease, Pericardial effusion
Clinical narrative: Within 12 hrs of this patient's vaccination, she developed high fevers then proceeded in the next 24 hrs to developed Kawasaki Syndrome including eye changes, generalized rash and oral changes - confirmed by Dr. Treated with IV gammaglobulin.  5/11/07 Received medical records from initial hospital which reveal patient seen in ER on 4/20/07 for fever, decreased appetite, runny nose, agitation & excessive crying since receiveing vax on 4/19. Dx: vaccine related fever.  Treated w/antipyretic & d/c to home. Returned to ER on 4/21 w/persistent fever, nasal stuffiness, cough, conjunctivitis, eye swelling & fussy.  Admitted 4/21/-4/22/07 to r/o sepsis.  Tx w/IV antibiotics.  Developed gen erythematous maculopapular rash.  Antibiotics d/cd.  Rash worsened & continued w/high fever & developed heart murmur.  Transferred to higher level of care to r/o Kawasaki syndrome.  ID consult done 4/23 revealed nasal congestion, bilateral conjunctivitis, dry & cracked lips, strawberry tongue, tachycardia, diffuse macular rash all over her body.  No bacterial focus for persistent fever.  Echocardiogram revealed small pleural effusion & coronary arteries were WNL.  Antibiotics were d/c & she was treated w/ASA & IVIG. Patient returned to ER at initial hospital on 4/27/07 w/complaints of intractable crying s/p hospital d/c for Kawaski disease.  Released from ER to see PCP in AM.  PCP rechecked patient on 4/27.  Exam neg except for known dermatitis/seborrhea on scalp & eczema on ears. 6/6/07 Received D/C Summary from higher level hospital which CDC had requested & faxed to VAERS.  Reveals patient admitted 4/22-4/26/07 after experienced 3 days of fever, emesis & 1 day of rash.  Seen at outlying ER w/fever, nasal stuffiness, cough, conjunctivitis, yellow eye discharge, slightly increased work of breathing & red dots on neck.  Admitted to outlying hospital for possible sepsis & started on antibiotics.  Rash spread to entire body s/p antibiotics & was then transferred for higher level of care.  Peds ID consult obtained & dx w/atypical Kawasakis disease.  Treated w/IVIG & ASA.  Rash & fever improved prior to d/c home on continued high dose ASA. FINAL DX: atypical Kawasaki disease.  Remainder of hospital records will be mailed. 6/8/07 Received vax record from PCP which confirms RO lot & dose #.  6/12/07 Received medical records from higher level hospital via fax from CDC which reveal patient experienced fever x 3 days, rash x 1 day, conjunctivitis & respiratory distress.  Admitted 4/22-4/26/07 after transfer from outlying hospital. ID consult obtained who made dx/atypical Kawasaki disease.  Treated w/high dose ASA & IVIG.  Fever, rash, strawbery tongue & conjunctivitis resolved by d/c to home.  To continue on high dose ASA for 3 more days then low dose ASA for 2 mo.  Close f/u w/PCP & f/u w/ID. FINAL DX: Kawaskis Disease, atypical.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia, Rash, Rash generalised
Clinical narrative: Within 12 hrs of this patient's vaccination, she developed high fevers then proceeded in the next 24 hrs to developed Kawasaki Syndrome including eye changes, generalized rash and oral changes - confirmed by Dr. Treated with IV gammaglobulin.  5/11/07 Received medical records from initial hospital which reveal patient seen in ER on 4/20/07 for fever, decreased appetite, runny nose, agitation & excessive crying since receiveing vax on 4/19. Dx: vaccine related fever.  Treated w/antipyretic & d/c to home. Returned to ER on 4/21 w/persistent fever, nasal stuffiness, cough, conjunctivitis, eye swelling & fussy.  Admitted 4/21/-4/22/07 to r/o sepsis.  Tx w/IV antibiotics.  Developed gen erythematous maculopapular rash.  Antibiotics d/cd.  Rash worsened & continued w/high fever & developed heart murmur.  Transferred to higher level of care to r/o Kawasaki syndrome.  ID consult done 4/23 revealed nasal congestion, bilateral conjunctivitis, dry & cracked lips, strawberry tongue, tachycardia, diffuse macular rash all over her body.  No bacterial focus for persistent fever.  Echocardiogram revealed small pleural effusion & coronary arteries were WNL.  Antibiotics were d/c & she was treated w/ASA & IVIG. Patient returned to ER at initial hospital on 4/27/07 w/complaints of intractable crying s/p hospital d/c for Kawaski disease.  Released from ER to see PCP in AM.  PCP rechecked patient on 4/27.  Exam neg except for known dermatitis/seborrhea on scalp & eczema on ears. 6/6/07 Received D/C Summary from higher level hospital which CDC had requested & faxed to VAERS.  Reveals patient admitted 4/22-4/26/07 after experienced 3 days of fever, emesis & 1 day of rash.  Seen at outlying ER w/fever, nasal stuffiness, cough, conjunctivitis, yellow eye discharge, slightly increased work of breathing & red dots on neck.  Admitted to outlying hospital for possible sepsis & started on antibiotics.  Rash spread to entire body s/p antibiotics & was then transferred for higher level of care.  Peds ID consult obtained & dx w/atypical Kawasakis disease.  Treated w/IVIG & ASA.  Rash & fever improved prior to d/c home on continued high dose ASA. FINAL DX: atypical Kawasaki disease.  Remainder of hospital records will be mailed. 6/8/07 Received vax record from PCP which confirms RO lot & dose #.  6/12/07 Received medical records from higher level hospital via fax from CDC which reveal patient experienced fever x 3 days, rash x 1 day, conjunctivitis & respiratory distress.  Admitted 4/22-4/26/07 after transfer from outlying hospital. ID consult obtained who made dx/atypical Kawasaki disease.  Treated w/high dose ASA & IVIG.  Fever, rash, strawbery tongue & conjunctivitis resolved by d/c to home.  To continue on high dose ASA for 3 more days then low dose ASA for 2 mo.  Close f/u w/PCP & f/u w/ID. FINAL DX: Kawaskis Disease, atypical.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: C-reactive protein increased, Eye disorder, Kawasaki's disease, Pericardial effusion, Pyrexia
Clinical narrative: Within 12 hrs of this patient's vaccination, she developed high fevers then proceeded in the next 24 hrs to developed Kawasaki Syndrome including eye changes, generalized rash and oral changes - confirmed by Dr. Treated with IV gammaglobulin.  5/11/07 Received medical records from initial hospital which reveal patient seen in ER on 4/20/07 for fever, decreased appetite, runny nose, agitation & excessive crying since receiveing vax on 4/19. Dx: vaccine related fever.  Treated w/antipyretic & d/c to home. Returned to ER on 4/21 w/persistent fever, nasal stuffiness, cough, conjunctivitis, eye swelling & fussy.  Admitted 4/21/-4/22/07 to r/o sepsis.  Tx w/IV antibiotics.  Developed gen erythematous maculopapular rash.  Antibiotics d/cd.  Rash worsened & continued w/high fever & developed heart murmur.  Transferred to higher level of care to r/o Kawasaki syndrome.  ID consult done 4/23 revealed nasal congestion, bilateral conjunctivitis, dry & cracked lips, strawberry tongue, tachycardia, diffuse macular rash all over her body.  No bacterial focus for persistent fever.  Echocardiogram revealed small pleural effusion & coronary arteries were WNL.  Antibiotics were d/c & she was treated w/ASA & IVIG. Patient returned to ER at initial hospital on 4/27/07 w/complaints of intractable crying s/p hospital d/c for Kawaski disease.  Released from ER to see PCP in AM.  PCP rechecked patient on 4/27.  Exam neg except for known dermatitis/seborrhea on scalp & eczema on ears. 6/6/07 Received D/C Summary from higher level hospital which CDC had requested & faxed to VAERS.  Reveals patient admitted 4/22-4/26/07 after experienced 3 days of fever, emesis & 1 day of rash.  Seen at outlying ER w/fever, nasal stuffiness, cough, conjunctivitis, yellow eye discharge, slightly increased work of breathing & red dots on neck.  Admitted to outlying hospital for possible sepsis & started on antibiotics.  Rash spread to entire body s/p antibiotics & was then transferred for higher level of care.  Peds ID consult obtained & dx w/atypical Kawasakis disease.  Treated w/IVIG & ASA.  Rash & fever improved prior to d/c home on continued high dose ASA. FINAL DX: atypical Kawasaki disease.  Remainder of hospital records will be mailed. 6/8/07 Received vax record from PCP which confirms RO lot & dose #.  6/12/07 Received medical records from higher level hospital via fax from CDC which reveal patient experienced fever x 3 days, rash x 1 day, conjunctivitis & respiratory distress.  Admitted 4/22-4/26/07 after transfer from outlying hospital. ID consult obtained who made dx/atypical Kawasaki disease.  Treated w/high dose ASA & IVIG.  Fever, rash, strawbery tongue & conjunctivitis resolved by d/c to home.  To continue on high dose ASA for 3 more days then low dose ASA for 2 mo.  Close f/u w/PCP & f/u w/ID. FINAL DX: Kawaskis Disease, atypical.