chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Lip swelling, Swollen tongue
Clinical narrative: Swelling of tongue and lips within 1 hr of recieving vaccines. ER visit
Age: 1.1
Sex: F
Vaccine: HIBV, MMRV, PNC
Symptoms: Pallor, Rash macular
Clinical narrative: Blanching macular rash to face, abdomen, chest, and arms 10 days after receiving Proquad vaccine.
Age: 15.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Headache, Laboratory test normal, Nausea, Vomiting
Clinical narrative: Client went on Sunday, March 11, 2007 complaining of headache, nausea and vomiting since Saturday, March 10, 2007.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Day 1: Left arm had DTaP and IVP vaccinations (right arm had MMR). Day 3: We noticed considerable swelling, redness and very hot left arm and shoulder (onset may have been much sooner - with the cold winter weather our son had on long sleeved shirts and pajamas at all times - we discovered because son was complaining of pain in the arm). Left arm was 20-25% larger than right arm. Returned to doctor immediately (48 hours after vaccinations). Dr. prescribed Cefadroxil 250MG/5ML Susp 100ML - 6ml twice/day for 10 days. No change for first 24 hours, but after 24 hours redness and swelling was reduced somewhat. Day 5: Dr. requested re-check visit. Swelling/redness/warmth down considerably. Day 8: (today) arm appears normal. Will have final Dr. visit 3/16/07 (Day 12) to verify complete recovery.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Hypotension, Mental status changes, Tachycardia
Clinical narrative: Postural hypotension,tachycardia, changes in mentation. Patient had La Bicillin at the same visit.
Age: 7.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Arm swollen and red, golf ball size. Advised to watch and see if it got any bigger, draw a circle around it. Call if she starts to act ill or run a fever. No treatment needed.
Age: 7.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Skin lesion
Clinical narrative: Arm swollen and red, golf ball size. Advised to watch and see if it got any bigger, draw a circle around it. Call if she starts to act ill or run a fever. No treatment needed.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Body temperature increased, Chills
Clinical narrative: Elevated temp and chills approx. 16 hours after vaccine given
Age: 17.0
Sex: F
Vaccine: HPVX, HPV4
Symptoms: Anxiety, Deafness, Fatigue, Flushing, Hypoaesthesia
Clinical narrative: 10:30am - Within 10 minutes of receiving vaccine, she fainted.  She began to experience severe pain in her left arm with numbness in her hands and fingers. She had feelings of impending dome.  11:30am - She returned to school approximately 1 hour after the injection, but her symptoms did not improve and worsened. She was unable to use her left arm do to the pain and lack of feeling/strength in her hand. She then had periods of hearing loss. She experienced nausea, vertigo, facial flushing, upper chest flushing, and profound fatigue.                             12:30pm - I returned her back to the MD office. There they did vital signs and administered Bendaryl by mouth.                                Her symptoms lasted 12 hours.  By the next morning, she back to normal.
Age: 17.0
Sex: F
Vaccine: HPVX, HPV4
Symptoms: Injected limb mobility decreased, Nausea, Pain in extremity, Syncope, Vertigo
Clinical narrative: 10:30am - Within 10 minutes of receiving vaccine, she fainted.  She began to experience severe pain in her left arm with numbness in her hands and fingers. She had feelings of impending dome.  11:30am - She returned to school approximately 1 hour after the injection, but her symptoms did not improve and worsened. She was unable to use her left arm do to the pain and lack of feeling/strength in her hand. She then had periods of hearing loss. She experienced nausea, vertigo, facial flushing, upper chest flushing, and profound fatigue.                             12:30pm - I returned her back to the MD office. There they did vital signs and administered Bendaryl by mouth.                                Her symptoms lasted 12 hours.  By the next morning, she back to normal.
Age: 17.0
Sex: F
Vaccine: HPVX, HPV4
Symptoms: Dizziness, Loss of consciousness, Pertussis, Syncope
Clinical narrative: 10:30am - Within 10 minutes of receiving vaccine, she fainted.  She began to experience severe pain in her left arm with numbness in her hands and fingers. She had feelings of impending dome.  11:30am - She returned to school approximately 1 hour after the injection, but her symptoms did not improve and worsened. She was unable to use her left arm do to the pain and lack of feeling/strength in her hand. She then had periods of hearing loss. She experienced nausea, vertigo, facial flushing, upper chest flushing, and profound fatigue.                             12:30pm - I returned her back to the MD office. There they did vital signs and administered Bendaryl by mouth.                                Her symptoms lasted 12 hours.  By the next morning, she back to normal.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: erythema, lump at injection site.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, RV5
Symptoms: Diarrhoea, Secondary transmission, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning her son-in-law, who had no medical history and allergies, whose daughter was vaccinated with a dose of Rotateq on approximately 01-FEB-2007. Concomitant vaccine administered on the same day included a dose of Pediarix. On approximately 03-FEB-2007, early in the morning, the father developed diarrhea and vomiting. He was seen by a family member who was a physician, and was placed on fluids. The diarrhea and vomiting continued for three days, and he missed one an half days of work. Most of his symptoms resolved within three days. It was noted that the father did not resume a regular diet until a week later. After a week he recovered completely. There were no laboratory or diagnostic test performed. No product quality complaint was involved. The patient's experienced were considered to be disabling by the reporter since her son-in-law missed work. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAP, IPV, PNC, RV5, DTAP, IPV, PNC, RV5
Symptoms: Blood test, Feeding disorder of infancy or early childhood, Pyrexia, Vomiting
Clinical narrative: Information has been received from a health professional concerning a 9 week old male, with no allergies and a history of premature birth, who on 20-FEB-2007 was vaccinated with a 2ml oral dose of Rotateq (lot #656105/1232F). Concomitant vaccines administered on the same day included a dose of Dtap,  Prevnar, and a dose of Ipol. Concomitant medication including SYNAGIS. The patient was seen in the office on 26-FEB-2007 with vomiting and a fever and was hospitalized. The patient was admitted for observation only and was discharged within 24 hours. It was reported that the patient was now feeding well, and had recovered. The patient experienced poor feeding and was hospitalized. No product quality complaint was involved. No other information was provided. The patient's experiences were considered to be immediately life-threatening and other important medical events by the reporter. A lot check has been requested. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAP, IPV, PNC, RV5, DTAP, IPV, PNC, RV5
Symptoms: Feeding disorder of infancy or early childhood, Hospitalisation, Pyrexia, Vomiting
Clinical narrative: Information has been received from a health professional concerning a 9 week old male, with no allergies and a history of premature birth, who on 20-FEB-2007 was vaccinated with a 2ml oral dose of Rotateq (lot #656105/1232F). Concomitant vaccines administered on the same day included a dose of Dtap,  Prevnar, and a dose of Ipol. Concomitant medication including SYNAGIS. The patient was seen in the office on 26-FEB-2007 with vomiting and a fever and was hospitalized. The patient was admitted for observation only and was discharged within 24 hours. It was reported that the patient was now feeding well, and had recovered. The patient experienced poor feeding and was hospitalized. No product quality complaint was involved. No other information was provided. The patient's experiences were considered to be immediately life-threatening and other important medical events by the reporter. A lot check has been requested. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Abnormal faeces, Diarrhoea, Fluid replacement, Vaccine positive rechallenge, Vomiting
Clinical narrative: Information has been received from a physician concerning an 8 week female who on a approximately 05-JAN-2007 (two months ago) was vaccinated with the first dose of Rotateq (lot #114P, invalid). Concomitant vaccinations included "routine two and four month vaccinations. On approximately 06-JAN-2007 ( the day after first vaccination), the patient developed vomiting and had frequent foul smelling diarrhea and possible loss of weight. She was taken to the emergency room and given IV fluids. There was no evidence of intussusception. In approximately March 2007 (at four months of age). The patient was vaccinated with the second dose of Rotateq. (lot #656193/0023U). Three to four days post vaccination (on approximately March 2007), the patient was taken to the emergency room with the same experience of vomiting and diarrhea. IV Fluids were administered. There was no evidence of intussusception. There was a possible loss of weight. There was no fever with either dose. Subsequently in an unspecified date, the patient recovered from vomiting, possible weight loss, and diarrhea. The reporter felt that the vomiting, possible weight loss and diarrhea were other important medical events. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Weight decreased
Clinical narrative: Information has been received from a physician concerning an 8 week female who on a approximately 05-JAN-2007 (two months ago) was vaccinated with the first dose of Rotateq (lot #114P, invalid). Concomitant vaccinations included "routine two and four month vaccinations. On approximately 06-JAN-2007 ( the day after first vaccination), the patient developed vomiting and had frequent foul smelling diarrhea and possible loss of weight. She was taken to the emergency room and given IV fluids. There was no evidence of intussusception. In approximately March 2007 (at four months of age). The patient was vaccinated with the second dose of Rotateq. (lot #656193/0023U). Three to four days post vaccination (on approximately March 2007), the patient was taken to the emergency room with the same experience of vomiting and diarrhea. IV Fluids were administered. There was no evidence of intussusception. There was a possible loss of weight. There was no fever with either dose. Subsequently in an unspecified date, the patient recovered from vomiting, possible weight loss, and diarrhea. The reporter felt that the vomiting, possible weight loss and diarrhea were other important medical events. Additional information has been requested.
Sex: M
Vaccine: DTP, MMR
Symptoms: Encephalitis, Mental impairment
Clinical narrative: Information has been received from a pharmacist concerning a male who in approximately 1987 was vaccinated with an "unknown" vaccine, which was possibly either MMR II or DTP (manufacturer unknown). In approximately 1987, the patient experienced encephalitis and was mentally impaired as a result, which persisted. The mental impairment and encephalitis were considered to be disabling. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: DTAP, IPV, MMR
Symptoms: Anaphylactic reaction
Clinical narrative: Seriousness criteria other medically significant. Other manufacturers reference number: A0636909A. Initial report received from another manufacturer on 26 February 2007. The information was provided to the other company by a health care professional. A patient of unspecified age or gender received the following injection on an unspecified date, DTaP (manufacturer unspecified), Ipol, and MMR II for prophylaxis. The patient's medical history and concurrent medications were not provided. An unspecified time after vaccination, the patient experienced anaphylaxis that required an emergency room visit. The reporting pharmacist considered the event to be clinically significant (or requiring intervention). At the time of this report, the outcome of the event was unspecified. The reporter of this case is the same as for case 2007-00549, which involved a case of anaphylaxis following the administration of DTaP, Ipol, and MMR.
Sex: U
Vaccine: DTAP, IPV, MMR
Symptoms: Anaphylactic reaction
Clinical narrative: Seriousness criteria other medically significant. Other manufacturer's reference number: A0636913A. Initial report received from another manufacturer on 26 February 2007. The information was provided to the other company by a health care professional. A patient of unspecified age or gender received the following injections on an unspecified date: DTaP (manufacturer unspecified), Ipol, and MMR II for prophylaxis. The patient's medical history and concurrent medications were not provided. An unspecified time after vaccination, the patient experienced anaphylaxis that required an emergency room visit. The reporting pharmacist considered the event to be clinically significant (or requiring intervention). At the time of this report, the outcome of the event was unspecified. The reporter of this case is the same as for case 2007-00548, which involved a case of anaphylaxis following the administration of DTaP, Ipol and MMR.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Convulsion, Encephalitis, Intensive care
Clinical narrative: Encephalitis, Seizures hospitalized at medical center, including ICU stay. 3/23/07 Received medical records from hospital which reveal patient experienced vomiting, fatigue, weakness, facial & chest petechial rash.  Patient lived in dormitory at school, home on weekends.  Seen by PCP who sent to outlying ER for w/u.  While in ER patient had seizure & was admitted to ICU.  Had another seizure in ICU & was transferred to higher level of care on 12/7/06-1/5/07.  On admit exam showed not responsive to commands but opening eyes to voice & pain.  DTRs absent.  +Babinski on R & - on L.  Consults by neuro, ID & neurosurg.  Tx w/antibiotics, antivirals, multi antiseizure meds & IVIG.  Experienced rash & all meds d/c.  Then seizures recurred & antiseizure med restarted x 1.  Developed mild bone marrow suppression thought to be due to antiviral med.  Patient began to respond on 12/20 & gradually improved to almose full function by d/c on 1/5 to outpatient rehab. FINAL DX: Encephalitis.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral
Clinical narrative: 3 days after vaccine-local forearms spreading redness with swelling
Age: 0.18
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Haematochezia, Mass, Mucous stools, Pseudomembranous colitis
Clinical narrative: 1/25/07 Blood and mucous in stool approx 21 days after 2 month old well visit with live Rota vaccines. 2/16/06 right lower quadrant mass palpated but ultrasonic neg intussusception at later visit for another episode. 2/16/07 C difficult toxin positive-pseudomemb. colitis.
Age: 16.0
Sex: M
Vaccine: HEPA, IPV, MMRV, TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: No known adverse event-upon review of immunization record, it was noted that patient received Proquad on 2/1/07- This is not for use in children >12 years old.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Irritability, Rash, Rash erythematous, Rash papular
Clinical narrative: Pt seen in ER 3/4/07 for eval of rash. Active, fussy, widely scattered, erythematous, papular areas noted on trunk, abd, arms and legs. They do not blouch. Not vesicular in their appearance.
Age: 61.0
Sex: M
Vaccine: PPV, VARZOS, VARZOS
Symptoms: Bone pain, Erythema, Gait disturbance, Hypokinesia, Myalgia
Clinical narrative: Over the first eight hours muscle and bone aching occurring, caused inability to lift arm. Swelling developed from distal axilla to mid forearm. Aching 5 days. Redness developed after 36 hrs and persisted for 6 days.
Age: 61.0
Sex: M
Vaccine: PPV, VARZOS, VARZOS
Symptoms: Oedema peripheral, Pain
Clinical narrative: Over the first eight hours muscle and bone aching occurring, caused inability to lift arm. Swelling developed from distal axilla to mid forearm. Aching 5 days. Redness developed after 36 hrs and persisted for 6 days.
Age: 61.0
Sex: M
Vaccine: PPV, VARZOS, VARZOS
Symptoms: Erythema, Generalised erythema, Injection site swelling, Oedema, Oedema peripheral
Clinical narrative: Over the first eight hours muscle and bone aching occurring, caused inability to lift arm. Swelling developed from distal axilla to mid forearm. Aching 5 days. Redness developed after 36 hrs and persisted for 6 days.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Headache, Hypersomnia, Hypoaesthesia, Hypokinesia
Clinical narrative: 1/31/07 tc from mother-states patient had HPV vaccine 1/19/07 on 1/20/07 c/o achy arms.  Developed headache that comes and goes and blurred vision the comes and goes.  On 1/26/07 c/o weakness-couldn't move-went to hosp ER-was in ER for 8 hours. No convulsion for use of symptoms.  Able to move now but has charge of sensation of left side. Mom states had been sleeping a lot.  2/21/07-Return call from mom. Completed form with available info, lasted 6 days-numbness/tingling. 03/30/07-records received from reporter. PE:WNL Pain when walking able to walk with some poor effort on examination but grossly normal musculoskeletal exam. Dehydration, musculoskeletal pain. Orthostatic blood pressure mostly likely due to poor oral intake. Sore throat and nasal congestion. Numbness in toes and feel and intermittent blurring of vision and seemed confused. Tired. Mother concerned about possible bipolar disorder. Multiple stressors in home life. Recommended mental health care provider
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Pain in extremity, Paraesthesia, Sensory disturbance, Vision blurred
Clinical narrative: 1/31/07 tc from mother-states patient had HPV vaccine 1/19/07 on 1/20/07 c/o achy arms.  Developed headache that comes and goes and blurred vision the comes and goes.  On 1/26/07 c/o weakness-couldn't move-went to hosp ER-was in ER for 8 hours. No convulsion for use of symptoms.  Able to move now but has charge of sensation of left side. Mom states had been sleeping a lot.  2/21/07-Return call from mom. Completed form with available info, lasted 6 days-numbness/tingling. 03/30/07-records received from reporter. PE:WNL Pain when walking able to walk with some poor effort on examination but grossly normal musculoskeletal exam. Dehydration, musculoskeletal pain. Orthostatic blood pressure mostly likely due to poor oral intake. Sore throat and nasal congestion. Numbness in toes and feel and intermittent blurring of vision and seemed confused. Tired. Mother concerned about possible bipolar disorder. Multiple stressors in home life. Recommended mental health care provider
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: Oedema peripheral
Clinical narrative: Arm began swelling 2-28-07. 3-1-07 entire arm began to swell. 3-2-07 hand is swollen.
Age: 0.51
Sex: F
Vaccine: DTAP, PNC, RV5
Symptoms: Blood culture, Culture urine, Frequent bowel movements, Full blood count, Pyrexia
Clinical narrative: Fever (101.2), screaming, frequent stools (4-5/day).
Age: 0.51
Sex: F
Vaccine: DTAP, PNC, RV5
Symptoms: Screaming, Urine analysis
Clinical narrative: Fever (101.2), screaming, frequent stools (4-5/day).
Age: 15.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Swelling, erythema and tender, left upper arm
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Incorrect dose administered
Clinical narrative: Adult dose of Hepatitis A given (1440 elu) instead of pediatric dose of Hepatitis A (720 elu)
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Adult dose of Hepatitis A given (1440 elu) instead of Pediatric dose of Hepatitis A (720 elu).
Age: 12.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC
Symptoms: Incorrect dose administered
Clinical narrative: Adult dose of Hepatitis A given (1440 elu) instead of Pediatric dose of Hepatitis A (720 elu).
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Pain, Skin warm
Clinical narrative: On Thursday 3/8/07, left arm red and swollen, felt achy all over. Today, 3/12/07 arm still red and warm from elbow to shoulder.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Erythema, Pruritus
Clinical narrative: Within 1/2 hr of receiving injection pt complained of face itching.  Within 1 hour face and neck burning red and itchy. Given Benadryl at school. Slept several hours, still complaining of itching when she woke up.  Resolved without further treatment.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Inflammation, Pruritus, Skin warm
Clinical narrative: Inflammation and redness on left upper arm. Itching and warm to touch.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Injection site reaction, Irritability, Skin warm
Clinical narrative: Local reaction to right outer thigh. Warm to touch approx 3-4 cm in size infant pt fussy.  Afebrile. No other symptoms.
Age: 1.29
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Erythema, Rash, Swelling
Clinical narrative: Red swollen leg. Had red speckled rash that turned into big red rash. Just a local reaction. Not having trouble breathing. MOC was advised to give pt Benadryl and call if symptoms worsened.
Age: 11.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Tender, warm, red 3x 6 cm reaction at site of Varivax #2; 48 hr after vaccine administration.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Asthenia, Urticaria, Vomiting
Clinical narrative: Pt is 7 y/o male with history of PDD pt developed vomiting and weakness within 5 min of vaccine.  Then developed rash which progressed to diffuse hives, no wheeze, no difficulty breathing. Pt responded well to oral Benadryl and IM Solumedrol.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Tdap given on 12/26/06. Pt received Tdap 5/16/06, Td 6/16/06. Should have received Td on 12/26/06.  Follow-up states no known adverse event occurred - Td should have been given. Tdap vaccine type BOOSTRIX, GSK - Lot# AC52B012AA.
Age: 7.0
Sex: F
Vaccine: DTAP, HBHEPB, IPV, MMR, VARCEL
Symptoms: Pruritus, Pyrexia, Rash papular, Skin lesion
Clinical narrative: Papulo vesicular lesions with itching, fever.
Age: 9.0
Sex: F
Vaccine: HEPA, MMR
Symptoms: Varicella
Clinical narrative: Chickenpox
Age: 5.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Drug ineffective, Varicella
Clinical narrative: Child came in office 3/6/07 and diagnosed with Varicella. All over back, abdomen and neck. Symptomatic care.
Age: 8.0
Sex: F
Vaccine: HIBV, PPV
Symptoms: Ecchymosis, Local reaction, Mass, Pain
Clinical narrative: Local reaction-very painful, edematous, hard lump and ecchymosis. Hurts to walk on. No erythema. Not warm to touch. Afebrile, warm compresses. Tylenol and Motrin.
Age: 19.0
Sex: M
Vaccine: HEPAB
Symptoms: Syncope, Unresponsive to stimuli, Vomiting
Clinical narrative: Fainted after Twinrix, TB skin test, and RPR drawn. Pt unresponsive 2-5 seconds, alert and oriented x 4, B/P 120/74 p-74, vomited one time, pt did not feel comfortable walking to car. Ambulance called, after EMS arrived, pt began to feel better and assisted to private vehicle, stating I feel fine now.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Crying, Pyrexia
Clinical narrative: Fever 106.5 began 4 hours after vaccine 12-11-06. Spoke with 24 hour RN if increased go to ER if not to continue Tylenol. 6am 102 deg resolved within 24 hours, no high pitched cry, no loss of color (white). Pt fussing, cried a little, cheeks red, played some.
Age: 3.0
Sex: F
Vaccine: HEPA, PNC
Symptoms: Erythema, Swelling
Clinical narrative: Left thigh with swelling, redness 1 cm x 20 cm.
Age: 69.0
Sex: F
Vaccine: TD
Symptoms: Influenza, Injection site swelling
Clinical narrative: Vaccine site swollen. Flu like illness for 1 week.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Erythema, Pallor
Clinical narrative: Diffuse body erythema, in thigh area. Blancher no true hives, no wheezing.
Age: 1.5
Sex: M
Vaccine: DTAPHEPBIP, HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Adult dose of Hepatitis A given (1440elu) instead of Pediatric dose of Hepatitis A (720 elu)
Age: 53.0
Sex: F
Vaccine: DTP, PPV
Symptoms: Chills, Fatigue, Nausea, Pyrexia, Sleep disorder
Clinical narrative: Chills, fatigue, nausea/vomiting, fever, no sleep
Age: 53.0
Sex: F
Vaccine: DTP, PPV
Symptoms: Vomiting
Clinical narrative: Chills, fatigue, nausea/vomiting, fever, no sleep
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Erythema, Pain, Swelling
Clinical narrative: Pain, redness, swelling. Cellulitis vs localised nxm.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, VARCEL, DTAP, IPV, VARCEL
Symptoms: Abdominal pain, Dysuria, Full blood count, Hypokinesia, Influenza
Clinical narrative: 3/3/07 Fever (102.4), leg pain, cannot walk or stand, unable to urinate, cannot sit on toilet, left-side abdominal pain, pain with palpation of thigh muscles, no erythema. (DTaP on 3/2/07 left thigh) complained of leg pain as soon as got home.  Did not want to walk. 3/6/07 diagnosed Influenza B.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, VARCEL, DTAP, IPV, VARCEL
Symptoms: Pain in extremity, Pyrexia, Tympanometry, Urine analysis
Clinical narrative: 3/3/07 Fever (102.4), leg pain, cannot walk or stand, unable to urinate, cannot sit on toilet, left-side abdominal pain, pain with palpation of thigh muscles, no erythema. (DTaP on 3/2/07 left thigh) complained of leg pain as soon as got home.  Did not want to walk. 3/6/07 diagnosed Influenza B.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, VARCEL, DTAP, IPV, VARCEL
Symptoms: Abdominal pain, Bladder obstruction, Dysuria, Full blood count, Hypokinesia
Clinical narrative: 3/3/07 Fever (102.4), leg pain, cannot walk or stand, unable to urinate, cannot sit on toilet, left-side abdominal pain, pain with palpation of thigh muscles, no erythema. (DTaP on 3/2/07 left thigh) complained of leg pain as soon as got home.  Did not want to walk. 3/6/07 diagnosed Influenza B.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, VARCEL, DTAP, IPV, VARCEL
Symptoms: Influenza, Pain in extremity, Palpitations, Pyrexia, Tympanometry
Clinical narrative: 3/3/07 Fever (102.4), leg pain, cannot walk or stand, unable to urinate, cannot sit on toilet, left-side abdominal pain, pain with palpation of thigh muscles, no erythema. (DTaP on 3/2/07 left thigh) complained of leg pain as soon as got home.  Did not want to walk. 3/6/07 diagnosed Influenza B.
Age: 13.0
Sex: M
Vaccine: HEPA
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Pt was pale, sweating, complaining of dizziness. Few minutes after he was given Hepatitis A vaccine.  Epinephrine 1:1000 wat given sc.  He recovered quickly.
Age: 10.0
Sex: M
Vaccine: HEPA
Symptoms: Contusion, Erythema, Hypoaesthesia, Pain, Rash macular
Clinical narrative: Bruising, blotching, redness, warmth, pain, numbness in arm
Age: 10.0
Sex: M
Vaccine: HEPA
Symptoms: Skin warm
Clinical narrative: Bruising, blotching, redness, warmth, pain, numbness in arm
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash erythematous, Swelling
Clinical narrative: Swollen left with red rash that was 6 in x 6 in. Leg was hot to the touch. MOC brought pt in for appt per physician request.
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia
Clinical narrative: Arthralgia (poly) following AVA #6.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Abdominal X-ray, Barium double contrast, Haematochezia, Intussusception, Surgery
Clinical narrative: Patient developed vomiting that progressively worsened over 2 days, followed by an episode of bloody stool. She was taken to the ED where they attempted an air enema x 3, at which time she was sent to surgery for surgical correction of severe intussusception.  03/14/07-records received from facility  DX:Ileocolic intussusception. Laparotomy and appendectomy.  C/O vomiting 4-6 times per day for 2 days. 10/26/06-bloody stool.  PE: WNL  Some issues with green stools and blood in stools when mom ate dairy products.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Patient developed vomiting that progressively worsened over 2 days, followed by an episode of bloody stool. She was taken to the ED where they attempted an air enema x 3, at which time she was sent to surgery for surgical correction of severe intussusception.  03/14/07-records received from facility  DX:Ileocolic intussusception. Laparotomy and appendectomy.  C/O vomiting 4-6 times per day for 2 days. 10/26/06-bloody stool.  PE: WNL  Some issues with green stools and blood in stools when mom ate dairy products.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Asthenia, Erythema, Pain, Swelling
Clinical narrative: Pneumovax injection 1-30-07 left forearm swelling pain, tightness. Appt 1-31-07 pt cancelled appt. Appt 2-1-07 prescription for Amoxicillin, Atarax, IBP, rest elevation and cold compress. Return to clinic if not better follow up call from doctor to pt 2-8-07.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Joint stiffness, Oedema peripheral, Pain
Clinical narrative: Pneumovax injection 1-30-07 left forearm swelling pain, tightness. Appt 1-31-07 pt cancelled appt. Appt 2-1-07 prescription for Amoxicillin, Atarax, IBP, rest elevation and cold compress. Return to clinic if not better follow up call from doctor to pt 2-8-07.
Age: 0.54
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC, RV5, DTAPHEPBIP, FLU3, PNC, RV5, DTAPHEPBIP, FLU3, PNC, RV5
Symptoms: Diarrhoea, Intussusception, Ultrasound scan, Vomiting
Clinical narrative: Information has been received concerning a 6 month old male with eczema and recurrent wheezing and a history of respiratory syncytial virus bronchiolitis who on 29-JAN-2007 was vaccinated PO with a second dose of Rotateq (Lot #654663/0942F). Concomitant vaccination administered that day included an IM second dose of Pediarix (lot #AC21B097AB), an IM first dose of Fluzone (lot # UT2191KA) and an IM second dose of Prevnar (lot B08691A). There were no other medications. The patient developed explosive diarrhea and emesis shortly after the vaccine was given. On 06-FEB-2007 the patient was admitted to the hospital for worsening vomiting. On the morning of 07-FEB-2007 he was found to have intussusception. A stool culture and viral studies were to be done. An ultrasound showed ileocolic intussusception and the patient was transferred. The patient's outcome was not known. The patient's adverse events were considered to be life threatening. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met requirements and was released by the regulatory agency. Follow-up information received on 05-MAR-2007 indicated that the patient had a barium enema. Additional information has been requested.
Age: 0.54
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC, RV5, DTAPHEPBIP, FLU3, PNC, RV5, DTAPHEPBIP, FLU3, PNC, RV5
Symptoms: Culture stool, Diarrhoea, Intussusception, Ultrasound scan abnormal, Vomiting
Clinical narrative: Information has been received concerning a 6 month old male with eczema and recurrent wheezing and a history of respiratory syncytial virus bronchiolitis who on 29-JAN-2007 was vaccinated PO with a second dose of Rotateq (Lot #654663/0942F). Concomitant vaccination administered that day included an IM second dose of Pediarix (lot #AC21B097AB), an IM first dose of Fluzone (lot # UT2191KA) and an IM second dose of Prevnar (lot B08691A). There were no other medications. The patient developed explosive diarrhea and emesis shortly after the vaccine was given. On 06-FEB-2007 the patient was admitted to the hospital for worsening vomiting. On the morning of 07-FEB-2007 he was found to have intussusception. A stool culture and viral studies were to be done. An ultrasound showed ileocolic intussusception and the patient was transferred. The patient's outcome was not known. The patient's adverse events were considered to be life threatening. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met requirements and was released by the regulatory agency. Follow-up information received on 05-MAR-2007 indicated that the patient had a barium enema. Additional information has been requested.
Age: 0.54
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC, RV5, DTAPHEPBIP, FLU3, PNC, RV5, DTAPHEPBIP, FLU3, PNC, RV5
Symptoms: Barium enema, Diarrhoea, Intussusception, Ultrasound scan, Ultrasound scan abnormal
Clinical narrative: Information has been received concerning a 6 month old male with eczema and recurrent wheezing and a history of respiratory syncytial virus bronchiolitis who on 29-JAN-2007 was vaccinated PO with a second dose of Rotateq (Lot #654663/0942F). Concomitant vaccination administered that day included an IM second dose of Pediarix (lot #AC21B097AB), an IM first dose of Fluzone (lot # UT2191KA) and an IM second dose of Prevnar (lot B08691A). There were no other medications. The patient developed explosive diarrhea and emesis shortly after the vaccine was given. On 06-FEB-2007 the patient was admitted to the hospital for worsening vomiting. On the morning of 07-FEB-2007 he was found to have intussusception. A stool culture and viral studies were to be done. An ultrasound showed ileocolic intussusception and the patient was transferred. The patient's outcome was not known. The patient's adverse events were considered to be life threatening. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met requirements and was released by the regulatory agency. Follow-up information received on 05-MAR-2007 indicated that the patient had a barium enema. Additional information has been requested.
Age: 0.54
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC, RV5, DTAPHEPBIP, FLU3, PNC, RV5, DTAPHEPBIP, FLU3, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received concerning a 6 month old male with eczema and recurrent wheezing and a history of respiratory syncytial virus bronchiolitis who on 29-JAN-2007 was vaccinated PO with a second dose of Rotateq (Lot #654663/0942F). Concomitant vaccination administered that day included an IM second dose of Pediarix (lot #AC21B097AB), an IM first dose of Fluzone (lot # UT2191KA) and an IM second dose of Prevnar (lot B08691A). There were no other medications. The patient developed explosive diarrhea and emesis shortly after the vaccine was given. On 06-FEB-2007 the patient was admitted to the hospital for worsening vomiting. On the morning of 07-FEB-2007 he was found to have intussusception. A stool culture and viral studies were to be done. An ultrasound showed ileocolic intussusception and the patient was transferred. The patient's outcome was not known. The patient's adverse events were considered to be life threatening. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met requirements and was released by the regulatory agency. Follow-up information received on 05-MAR-2007 indicated that the patient had a barium enema. Additional information has been requested.
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Death, Gastrointestinal necrosis, Septic shock
Clinical narrative: Information has been received concerning a female with unrepaired ambiguous genitalia, and a history of prematurity, non surgical necrotizing enterocolitis, bilateral hydronephrosis, klebsiella, urinary tract infection, sepsis, and omphalocele, who on 28-NOV-2006 was vaccinated with a first oral dose of Rotateq (lot #654248/0577F). Concomitant vaccines administered on the same day included a first intramuscular dose in the right leg of Pediarix (lot #AC21B64AA), a first intramuscular dose in the right leg of PedvaxHib (lot #652502/0719R) and a first intramuscular dose in the left leg of Prevnar (lot #B08672F). Concomitant therapy included SYNAGIS, beginning on 21-NOV-2006, POLY-VI-SOL WITH IRON TABLETS, and prophylactic amoxicillin. On 09-DEC-2006 the patient presented to the emergency room with septic shock secondary to a necrotic bowel and was hospitalized. Subsequently on 09-DEC-2006 the patient died. The patient's reactions were considered to be immediately life threatening by the reporter. Lot checks were requested. The records of testing prior to release of the lots in question, 0577F and 0719R, have been rechecked and found to be satisfactory. The lots met the requirements and were released. Additional information is not expected.
Age: 0.5
Sex: F
Vaccine: HIBV, IPV
Symptoms: Diarrhoea, Vomiting
Clinical narrative: One week after receiving HiB + IPV vaccines, pt began vomiting formula, which lasted for 3 days. Diarrhea was also present during this time, though not as frequent as the vomiting. She was able to keep down Pedialyte and slowly began keeping down 1/2 strength formulation by 3/5/07. She was not exposed to any other illness before or after the vaccinations and had no fever during the time of this possible reaction. She now seems fully recovered, though I will continue watching her for problems.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Muscle swelling, Pruritus, Rash
Clinical narrative: Around 1 pm-itchy a lot but able to move arm, no fever, O/E 10 cm x 6 cm-swelling of muscle noted-circle rash-shape of bandage notice on 3/11/07
Age: 0.17
Sex: F
Vaccine: DTAP, HBHEPB, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Haematochezia, Laboratory test, Stool analysis
Clinical narrative: Information has been received from a physician concerning a 2 month old female who on 12-FEB-2007 was vaccinated with a 2ml oral dose of Rotateq (lot #115F). Concomitant vaccination administered that day included a dose of Comvax, Prevnar and Dtap. The patient "may have had" blood in stool at the time of vaccination. On 12-FEB-2007 the patient developed hematochezia. A lab test was performed to verify if there was blood in stool, the results were not reported. Subsequently, the patient recovered. The patient's hematochezia was considered to be an other important medical event. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAP, HBHEPB, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Culture stool negative, Haematochezia, Mucous stools, Occult blood positive
Clinical narrative: Information has been received from a physician concerning a 2 month old female who on 12-FEB-2007 was vaccinated with a 2ml oral dose of Rotateq (lot #115F). Concomitant vaccination administered that day included a dose of Comvax, Prevnar and Dtap. The patient "may have had" blood in stool at the time of vaccination. On 12-FEB-2007 the patient developed hematochezia. A lab test was performed to verify if there was blood in stool, the results were not reported. Subsequently, the patient recovered. The patient's hematochezia was considered to be an other important medical event. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Allergy test, Culture stool, Haematochezia, Rotavirus test
Clinical narrative: Information has been received from a physician assistant concerning a female with no pertinent medical history was vaccinated with the second oral dose of Rotateq (human-bovine) (lot # not provided). There was no concomitant medication. Subsequently, the patient experienced blood in her stool after receiving the second dose. The patient sought unspecified medical treatment. There was no product quality complaint involved. Upon internal review, blood in her stool considered to be an other important medical event. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Allergy test, Culture stool, Haematochezia
Clinical narrative: Information has been received from a physician assistant concerning a female with no pertinent medical history was vaccinated with the second oral dose of Rotateq (human-bovine) (lot # not provided). There was no concomitant medication. Subsequently, the patient experienced blood in her stool after receiving the second dose. The patient sought unspecified medical treatment. There was no product quality complaint involved. Upon internal review, blood in her stool considered to be an other important medical event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abortion, Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Information has been received from a registered nurse through a pregnancy registry concerning a female (age not reported) who on an unspecified date was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil. The patient was pregnant, and on 28-FEB-2007 the patient had a miscarriage or abortion after receiving the first dose of Gardasil. The patient sought unspecified medical attention. At the time of this report, the nurse was unsure if the patient had a miscarriage or abortion. Upon internal review, the patient's miscarriage or abortion was considered an other important medical event. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative, Hepatic function abnormal, Liver function test abnormal, Oxygen supplementation, Polymerase chain reaction
Clinical narrative: Information has been received from a physician concerning a 5 year old male, with a history of red man syndrome associated with vancomycin, who in 2003 was vaccinated with 0.5ml of Varivax, he was also diagnosed with leukemia. concomitant therapy included Chemotherapy medications (unspecified). Twelve months after being vaccinated, in 2004, testing showed that the patient had no titers, and had not seroconverted. On approximately 24-FEB-2007, the patient presented with a rash and fever which was polymerase-chain-reaction (PCR) tested. Results showed that it was positive for Varicella-Zoster virus. The patient was also reported to have been in respiratory distress for one hour, and was on oxygen therapy. The patient recovered from respiratory distress. The patient also had elevated liver function tests. The patient is being treated with intravenous acyclovir, to which he is responding. The patients status, at the time of this report, was considered to be recovering. Medical attention was sought. The patient was hospitalized on an undisclosed date. There was no product quality complaint. The events were considered to be other medical important events. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Respiratory distress, Seroconversion test negative, Vaccination failure
Clinical narrative: Information has been received from a physician concerning a 5 year old male, with a history of red man syndrome associated with vancomycin, who in 2003 was vaccinated with 0.5ml of Varivax, he was also diagnosed with leukemia. concomitant therapy included Chemotherapy medications (unspecified). Twelve months after being vaccinated, in 2004, testing showed that the patient had no titers, and had not seroconverted. On approximately 24-FEB-2007, the patient presented with a rash and fever which was polymerase-chain-reaction (PCR) tested. Results showed that it was positive for Varicella-Zoster virus. The patient was also reported to have been in respiratory distress for one hour, and was on oxygen therapy. The patient recovered from respiratory distress. The patient also had elevated liver function tests. The patient is being treated with intravenous acyclovir, to which he is responding. The patients status, at the time of this report, was considered to be recovering. Medical attention was sought. The patient was hospitalized on an undisclosed date. There was no product quality complaint. The events were considered to be other medical important events. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella, Varicella zoster virus serology positive
Clinical narrative: Information has been received from a physician concerning a 5 year old male, with a history of red man syndrome associated with vancomycin, who in 2003 was vaccinated with 0.5ml of Varivax, he was also diagnosed with leukemia. concomitant therapy included Chemotherapy medications (unspecified). Twelve months after being vaccinated, in 2004, testing showed that the patient had no titers, and had not seroconverted. On approximately 24-FEB-2007, the patient presented with a rash and fever which was polymerase-chain-reaction (PCR) tested. Results showed that it was positive for Varicella-Zoster virus. The patient was also reported to have been in respiratory distress for one hour, and was on oxygen therapy. The patient recovered from respiratory distress. The patient also had elevated liver function tests. The patient is being treated with intravenous acyclovir, to which he is responding. The patients status, at the time of this report, was considered to be recovering. Medical attention was sought. The patient was hospitalized on an undisclosed date. There was no product quality complaint. The events were considered to be other medical important events. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Rash
Clinical narrative: Patient had Gardasil (1st injection of series) on 2/26/07 10:00 am, 24 hours later developed pink rash on arms. torso and neck. Patient complain of itching, denies using any new meds or products. Patient came in for OV with doctor, was given Medrol dose pack.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Faeces hard, Infrequent bowel movements
Clinical narrative: After each Rotateq, no stool for 48 hours then hard pebble stool for 2-3 days. Otherwise fine.
Age: 0.18
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Abdominal pain, Cough, Diarrhoea, Dysphonia, Haematochezia
Clinical narrative: After Rotateq developed abdominal pain, diarrhea, dusky lips and extremities, pallor, fussiness, hoarseness, increase heart rate and nasal congestion and fever and cough and heme (+) stool,
Age: 0.18
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Heart rate increased, Irritability, Nasal congestion, Pallor, Pyrexia
Clinical narrative: After Rotateq developed abdominal pain, diarrhea, dusky lips and extremities, pallor, fussiness, hoarseness, increase heart rate and nasal congestion and fever and cough and heme (+) stool,
Age: 0.18
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Rotavirus test positive
Clinical narrative: After Rotateq developed abdominal pain, diarrhea, dusky lips and extremities, pallor, fussiness, hoarseness, increase heart rate and nasal congestion and fever and cough and heme (+) stool,
Sex: M
Vaccine: TDAP
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: Fever, chills, nausea.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Body temperature increased, Hyperhidrosis
Clinical narrative: Temperature of 103 degrees F, weakness, joint pain, diaphoretic for 2 days, treatment was rest and administration of 800 mg Ibuprofen every 6 hours.
Age: 3.0
Sex: F
Vaccine: DTAP, FLU3, HEPA, PNC
Symptoms: Injection site erythema, Oedema peripheral, Skin warm
Clinical narrative: Left arm began swelling, warm to touch and red at injection site. Recheck on 2/28 - swelling and redness have completely resolved. No pain.
Age: 64.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Oedema peripheral, Pruritus, Rash
Clinical narrative: One week after TD vaccination left arm began to swell - extended down arm to hand and up over shoulder - 2 wks went to M.D. received steroid injection - continued to spread - contacted office reported 2-22-07 - Encourage to return to M.D. - rash had spread around breast. MD Rx for medicine (pill) for itching and continued use of hydrocortisone cream. No report of diagnosis of injection.