chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 88.0
Sex: F
Vaccine: PPV
Symptoms: Respiratory rate, Skin discolouration, Sleep disorder, White blood cell count
Clinical narrative: Information has been received from a physician concerning an 88 year old white female patient, nonsmoker, with allergies to Ibuprofen and aspirin, asthma, hypothyroidism, questionable congestive heart failure, hypertension, gastro-esophageal reflux disease, generalised arthritis, hard of hearing, anxiety and a surgical history included tonsillectomy and a right hip replacement, who on 07-NOV-2007 at 8:30 AM was vaccinated intramuscularly with a first dose of PNEUMOVAX (Lot #658673/0990U).  Concomitant therapy included lorazepam (ATIVAN), one tablet at hour of sleep.  The physician stated that the patient's arm "looked horrible."  On 10-NOV-2007 she presented to the emergency room complaining of left upper arm redness, swelling, pain and discoloration after receiving the pneumonia shot.  The left upper arm was discolored, reddish, purple on the posterior aspect with swelling noted at the elbow.  Discoloration extends up to the axilla and is warm to touch.  The patient reports taking lorazepam (ATIVAN) at home - supposed to take one tablet at hour of sleep (QHS), but "needs it more often," and takes it more often than ordered.  It was also reported that the patient didn't sleep well.  The patient was treated with intravenous antibiotics and levofloxacin (LEVAQUIN) 500 mg at 10:10.  The patient complained of feeling "very nervous," and was given lorazepam (ATIVAN) 0.5 mg orally at 10:50.  The patient was also treated with atenolol, furosimide (LASIX), potassium chloride (MICRO K LOW) and synthroid.  Diagnostic laboratory studies included blood cultures indicating no growth at 6 days, white blood count 5.8 (4.0-10.5 K/uL), red blood cell count 4.06 (4.20-5.40 M/uL), mean corpuscular hemoglobin 33.3 (27-31 pg), lymphocyte count 19.6 (25-45%).  Subsequently, the patient recovered.  Discharge instructions were given to the patient to return to the emergency room on 11-NOV-2007 and 12-NOV-2007 for intravenous levofloxacin (LEVAQUIN) and recheck.  The patient will also take diphenhydramine hydrochloride (BENADRYL) at bedtime for sleep.  No product quality complaint was involved.  Left upper arm cellulitis and large bruise were considered to be other medically important events.  The patient also experienced burning soles of her feet and feeling nervous.  Additional information has been requested.  All medical records are available upon request.
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, HEPA, MNQ, TDAP, HEPA, MNQ, TDAP
Symptoms: Chest pain, Dyspnoea, Gait disturbance, Hemiparesis, Hypoaesthesia
Clinical narrative: This case was received from a physician on 02 April 2008.  A 15-year-old female, with an unknown medical history, received the following vaccinations on 27 March 2008: an intramuscular dose of Adacel (lot number C2862AA), an intramuscular dose of Menactra (lot number U2236AA), an intradermal dose of Tubersol (lot number not provided) and a dose of Vaqta (Merck, lot number 1258U).  The patient was not ill at the time of vaccination, and had experienced no adverse events following previous vaccinations.  She had a sibling with multiple sclerosis.  A few hours after vaccination, the patient complained of chest pain and shortness of breath, and was treated with Motrin.  At 3:00 the following morning, she awoke with right-sided facial swelling, right-sided numbness, and weakness in both upper and lower extremities.  She was admitted to the hospital, where testing for multiple sclerosis was negative.  Of note, her total cholesterol was found to be 292.  At the time of the report, the subject had not yet recovered.
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, HEPA, MNQ, TDAP, HEPA, MNQ, TDAP
Symptoms: Oedema peripheral, Swelling face
Clinical narrative: This case was received from a physician on 02 April 2008.  A 15-year-old female, with an unknown medical history, received the following vaccinations on 27 March 2008: an intramuscular dose of Adacel (lot number C2862AA), an intramuscular dose of Menactra (lot number U2236AA), an intradermal dose of Tubersol (lot number not provided) and a dose of Vaqta (Merck, lot number 1258U).  The patient was not ill at the time of vaccination, and had experienced no adverse events following previous vaccinations.  She had a sibling with multiple sclerosis.  A few hours after vaccination, the patient complained of chest pain and shortness of breath, and was treated with Motrin.  At 3:00 the following morning, she awoke with right-sided facial swelling, right-sided numbness, and weakness in both upper and lower extremities.  She was admitted to the hospital, where testing for multiple sclerosis was negative.  Of note, her total cholesterol was found to be 292.  At the time of the report, the subject had not yet recovered.
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, HEPA, MNQ, TDAP, HEPA, MNQ, TDAP
Symptoms: Cardiolipin antibody negative, Chest X-ray normal, Chest pain, Computerised tomogram normal, Depressed level of consciousness
Clinical narrative: This case was received from a physician on 02 April 2008.  A 15-year-old female, with an unknown medical history, received the following vaccinations on 27 March 2008: an intramuscular dose of Adacel (lot number C2862AA), an intramuscular dose of Menactra (lot number U2236AA), an intradermal dose of Tubersol (lot number not provided) and a dose of Vaqta (Merck, lot number 1258U).  The patient was not ill at the time of vaccination, and had experienced no adverse events following previous vaccinations.  She had a sibling with multiple sclerosis.  A few hours after vaccination, the patient complained of chest pain and shortness of breath, and was treated with Motrin.  At 3:00 the following morning, she awoke with right-sided facial swelling, right-sided numbness, and weakness in both upper and lower extremities.  She was admitted to the hospital, where testing for multiple sclerosis was negative.  Of note, her total cholesterol was found to be 292.  At the time of the report, the subject had not yet recovered.
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, HEPA, MNQ, TDAP, HEPA, MNQ, TDAP
Symptoms: Echocardiogram, Electrocardiogram normal, Factor V Leiden mutation, Hemiparesis, Hypoaesthesia
Clinical narrative: This case was received from a physician on 02 April 2008.  A 15-year-old female, with an unknown medical history, received the following vaccinations on 27 March 2008: an intramuscular dose of Adacel (lot number C2862AA), an intramuscular dose of Menactra (lot number U2236AA), an intradermal dose of Tubersol (lot number not provided) and a dose of Vaqta (Merck, lot number 1258U).  The patient was not ill at the time of vaccination, and had experienced no adverse events following previous vaccinations.  She had a sibling with multiple sclerosis.  A few hours after vaccination, the patient complained of chest pain and shortness of breath, and was treated with Motrin.  At 3:00 the following morning, she awoke with right-sided facial swelling, right-sided numbness, and weakness in both upper and lower extremities.  She was admitted to the hospital, where testing for multiple sclerosis was negative.  Of note, her total cholesterol was found to be 292.  At the time of the report, the subject had not yet recovered.
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, HEPA, MNQ, TDAP, HEPA, MNQ, TDAP
Symptoms: Inappropriate schedule of drug administration, Lipoprotein (a) increased, Nuclear magnetic resonance imaging brain normal, Polymerase chain reaction, Protein S normal
Clinical narrative: This case was received from a physician on 02 April 2008.  A 15-year-old female, with an unknown medical history, received the following vaccinations on 27 March 2008: an intramuscular dose of Adacel (lot number C2862AA), an intramuscular dose of Menactra (lot number U2236AA), an intradermal dose of Tubersol (lot number not provided) and a dose of Vaqta (Merck, lot number 1258U).  The patient was not ill at the time of vaccination, and had experienced no adverse events following previous vaccinations.  She had a sibling with multiple sclerosis.  A few hours after vaccination, the patient complained of chest pain and shortness of breath, and was treated with Motrin.  At 3:00 the following morning, she awoke with right-sided facial swelling, right-sided numbness, and weakness in both upper and lower extremities.  She was admitted to the hospital, where testing for multiple sclerosis was negative.  Of note, her total cholesterol was found to be 292.  At the time of the report, the subject had not yet recovered.
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, HEPA, MNQ, TDAP, HEPA, MNQ, TDAP
Symptoms: Scan brain, Swelling face, Type I hypersensitivity, Ultrasound Doppler normal, Ultrasound scan normal
Clinical narrative: This case was received from a physician on 02 April 2008.  A 15-year-old female, with an unknown medical history, received the following vaccinations on 27 March 2008: an intramuscular dose of Adacel (lot number C2862AA), an intramuscular dose of Menactra (lot number U2236AA), an intradermal dose of Tubersol (lot number not provided) and a dose of Vaqta (Merck, lot number 1258U).  The patient was not ill at the time of vaccination, and had experienced no adverse events following previous vaccinations.  She had a sibling with multiple sclerosis.  A few hours after vaccination, the patient complained of chest pain and shortness of breath, and was treated with Motrin.  At 3:00 the following morning, she awoke with right-sided facial swelling, right-sided numbness, and weakness in both upper and lower extremities.  She was admitted to the hospital, where testing for multiple sclerosis was negative.  Of note, her total cholesterol was found to be 292.  At the time of the report, the subject had not yet recovered.
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, HEPA, MNQ, TDAP, HEPA, MNQ, TDAP
Symptoms: Blood cholesterol increased, Chest pain, Dyspnoea, Hypoaesthesia, Laboratory test normal
Clinical narrative: This case was received from a physician on 02 April 2008.  A 15-year-old female, with an unknown medical history, received the following vaccinations on 27 March 2008: an intramuscular dose of Adacel (lot number C2862AA), an intramuscular dose of Menactra (lot number U2236AA), an intradermal dose of Tubersol (lot number not provided) and a dose of Vaqta (Merck, lot number 1258U).  The patient was not ill at the time of vaccination, and had experienced no adverse events following previous vaccinations.  She had a sibling with multiple sclerosis.  A few hours after vaccination, the patient complained of chest pain and shortness of breath, and was treated with Motrin.  At 3:00 the following morning, she awoke with right-sided facial swelling, right-sided numbness, and weakness in both upper and lower extremities.  She was admitted to the hospital, where testing for multiple sclerosis was negative.  Of note, her total cholesterol was found to be 292.  At the time of the report, the subject had not yet recovered.
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, HEPA, MNQ, TDAP, HEPA, MNQ, TDAP
Symptoms: Muscular weakness, Swelling face
Clinical narrative: This case was received from a physician on 02 April 2008.  A 15-year-old female, with an unknown medical history, received the following vaccinations on 27 March 2008: an intramuscular dose of Adacel (lot number C2862AA), an intramuscular dose of Menactra (lot number U2236AA), an intradermal dose of Tubersol (lot number not provided) and a dose of Vaqta (Merck, lot number 1258U).  The patient was not ill at the time of vaccination, and had experienced no adverse events following previous vaccinations.  She had a sibling with multiple sclerosis.  A few hours after vaccination, the patient complained of chest pain and shortness of breath, and was treated with Motrin.  At 3:00 the following morning, she awoke with right-sided facial swelling, right-sided numbness, and weakness in both upper and lower extremities.  She was admitted to the hospital, where testing for multiple sclerosis was negative.  Of note, her total cholesterol was found to be 292.  At the time of the report, the subject had not yet recovered.
Age: 85.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Eye swelling, Rash, Scab
Clinical narrative: Shingles vaccine caused shingles.  5 days after shot, got red rash on eyelid, red rash on scalp.  Diagnosed with shingles by Dr. with shingles on March 28, 2008.  Rash progressed to forehead, trunk, back, and some on leg, rash turned to pox, has lightening like pain which shoots across his head.  Treated with anti-viral- famciclovir 500mg tid. and erythromycin opthalmic oint.
Age: 85.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Eye swelling, Scab
Clinical narrative: Shingles vaccine caused shingles.  5 days after shot, got red rash on eyelid, red rash on scalp.  Diagnosed with shingles by Dr. with shingles on March 28, 2008.  Rash progressed to forehead, trunk, back, and some on leg, rash turned to pox, has lightening like pain which shoots across his head.  Treated with anti-viral- famciclovir 500mg tid. and erythromycin opthalmic oint.
Age: 85.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash, Rash erythematous
Clinical narrative: Shingles vaccine caused shingles.  5 days after shot, got red rash on eyelid, red rash on scalp.  Diagnosed with shingles by Dr. with shingles on March 28, 2008.  Rash progressed to forehead, trunk, back, and some on leg, rash turned to pox, has lightening like pain which shoots across his head.  Treated with anti-viral- famciclovir 500mg tid. and erythromycin opthalmic oint.
Age: 85.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Eye swelling, Herpes zoster, Scab
Clinical narrative: Shingles vaccine caused shingles.  5 days after shot, got red rash on eyelid, red rash on scalp.  Diagnosed with shingles by Dr. with shingles on March 28, 2008.  Rash progressed to forehead, trunk, back, and some on leg, rash turned to pox, has lightening like pain which shoots across his head.  Treated with anti-viral- famciclovir 500mg tid. and erythromycin opthalmic oint.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein, Caesarean section, Drug exposure during pregnancy, Foetal disorder, Oestriol
Clinical narrative: Information has been received through the Merck pregnancy registry from a 21 year old female with seasonal allergies and a history of ureteric reimplantation (1996).  On 10-JAN-2007, the patient was vaccinated with the first 0.5 mL dose of Gardasil (Lot# not reported).  Concomitant medications included Augmentin, ibuprofen and unspecified prenatal vitamins.  It was reported that the patient later found out that she was six weeks pregnant.  The patient underwent a pregnancy test (date unknown).  It was reported that the patient has had no ill effects from this.  The patient sought unspecified medical attention.  At the time of this report, the outcome of the event was unknown.  Follow-up information was received from the patient who reported that she gave birth to a healthy baby boy on 03-OCT-2007.  The patient reported that labor and delivery went smooth and the baby was healthy and normal.  Additional follow up information was received from the physician.  Laboratory results included quad screen from 26-APR-2007 which was normal and ultrasounds results from 25-APR-2007 which were normal.  An ultrasound from 25-JUL-2007 revealed a low lying placenta which the physician considered to be within normal limits and on an unspecified date was considered to have resolved.  The physician reported that on 03-OCT-2007 the baby was delivered by a cesarean section due to cephalo pelvic disproportion.  Upon internal review this was determined to be a serious other medical event.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Placental disorder, Pregnancy test, Ultrasound scan abnormal
Clinical narrative: Information has been received through the Merck pregnancy registry from a 21 year old female with seasonal allergies and a history of ureteric reimplantation (1996).  On 10-JAN-2007, the patient was vaccinated with the first 0.5 mL dose of Gardasil (Lot# not reported).  Concomitant medications included Augmentin, ibuprofen and unspecified prenatal vitamins.  It was reported that the patient later found out that she was six weeks pregnant.  The patient underwent a pregnancy test (date unknown).  It was reported that the patient has had no ill effects from this.  The patient sought unspecified medical attention.  At the time of this report, the outcome of the event was unknown.  Follow-up information was received from the patient who reported that she gave birth to a healthy baby boy on 03-OCT-2007.  The patient reported that labor and delivery went smooth and the baby was healthy and normal.  Additional follow up information was received from the physician.  Laboratory results included quad screen from 26-APR-2007 which was normal and ultrasounds results from 25-APR-2007 which were normal.  An ultrasound from 25-JUL-2007 revealed a low lying placenta which the physician considered to be within normal limits and on an unspecified date was considered to have resolved.  The physician reported that on 03-OCT-2007 the baby was delivered by a cesarean section due to cephalo pelvic disproportion.  Upon internal review this was determined to be a serious other medical event.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Brain neoplasm benign, Surgery
Clinical narrative: Information has been received from a nurse concerning an 18 year old female patient who on 23-JUL-2007 was vaccinated with a first dose of GARDASIL. Concomitant therapy included ABILIFY. The nurse reported that the patient developed a benign brain tumor in the fall of 2007 after receiving GARDASIL. She required surgery and was hospitalized. She recovered on an unspecified day. The nurse felt that patient having benign brain neoplasm and requiring surgery was to prevent serious criteria and reported event as Other Medical Event (OME). Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a 17 year old female patient who was vaccinated with a dose of GARDASIL (unknown dose by caller) at another office. The physician reported that the patient developed seizure-like activities after receiving the GARDASIL. The physician consulted with specialists at the University and they concluded that it was from the GARDASIL. He also reported that the information relayed by the patient's mother who stated that her daughter had been evaluated by a pediatric cardiologist and pediatric neurologist for syncopal episodes/seizure like episodes following the vaccination but not associated with receipt of GARDASIL. The outcome was unknown. Upon internal review "seizure-like activities" was determined to be an other important medical event. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium enema abnormal, Intussusception
Clinical narrative: Information has been received from a physician concerning a "pretty normal healthy" 9 week old patient who on 14-MAR-2008 was vaccinated PO with the initial 2.0 ml dose of ROTATEQ (lot# 659913/1702U).  Concomitant vaccinations included a dose of ACTHIB, a dose of PREVNAR and a dose of PEDIARIX.  On 20-MAR-2008 the patient experienced intussusception and on 21-MAR-2008 was diagnosed with intussusception and was hospitalized for 5 days.  The intussusception did not resolve after the barium enema and the patient was taken to surgery for a loop reduction.  Per physician, "the patient's intestines were retracted and did not have to be cut."  The patient was discharged on 25-MAR-2008.  the physician saw the patient on 27-MAR-2008 and noted that the patient was recovered/resolved when it came to "feeding and everything."  The patient's stitches were still dissolving.  There was no product quality complaint.  Intussusception was also considered to be immediately life-threatening and an other important medical event (surgery) by the physician.  Additional information has been requested. 05/29/08-records received for DOS  3/21-3/25/08-DX DC: Intussusception Status post reduction. Appendectomy. Developed abdominal pain. Increased abdominal distention, emesis morning of admission. Fussy. Heart rate increased. Urine output decreased. Stool bloody. Exploratory laparotomy and incidental appendectomy. Barium enema was unsuccessful. Developed post op ileus. NG placement.
Age: 0.38
Sex: F
Vaccine: RV5
Symptoms: Crying, Diarrhoea, Intussusception, Vomiting
Clinical narrative: Information has been received from a physician concerning a 26 week old female who on 25-MAY-2007 and 08-AUG-2007 was vaccinated PO with her first and second 2.0 ml doses of Rotateq (lot# "12337," 656393/0240U).  On 21-SEP-2007 the patient was seen in the physician's office since the patient experienced vomiting, crying and loose stools.  The patient did not have bloody stools.  The patient was admitted to a hospital that same day and was diagnosed with intussusception.  The patient was hospitalized for 3 days.  A barium enema resolved the intussusception.  The patient was discharged from the hospital on 23-SEP-2007.  On 24-SEP-2007 the patient was seen in the physician's office and the physician stated the patient had been vomiting, but with no dehydration.  The patient had a bowel movement with no blood in the stools.  Therapy with Rotateq was discontinued on 08-AUG-2007.  The physician stated the patient was recovering.  There was no product quality complaint.  Additional information has been requested.8/4/08-records received for DOS 9/21-9/23/07-DC DX: Intussusception. Presented to ED with C/O vomiting and loose bowel movement times 1-2 days. Crying, irritable.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Gastrointestinal necrosis, Intestinal resection, Intussusception, Lethargy
Clinical narrative: Information has been received from a physician concerning a 21 week old male who on an unknown date and on 20-MAR-2007 was vaccinated PO with his first and second 2.0 ml doses of Rotateq.  On approximately 07-APR-2007 per the physician, "the patient was brought into the office at 5 months old and was lethargic."  On 27-APR-2007 the patient diagnosed with intussusception and was hospitalized (amount of time unknown).  Surgery was performed and the patient had a necrotic bowel therefore the bowel had to be resected.  The patient returned to the office for a follow-up visit and the third dose of Rotateq was administered by a different provider in the office.  Subsequently, the patient recovered.  There was no product quality complaint.  Intussusception was also considered to be an other important medical event (surgery) by the physician.  Additional information has been requested. 4/22/08-record received-Surgical report 4/29/07-Intussusception, ileocolic and ilioiliac due to mesenteric adenitis and possible hypertrophic tire patches, terminal ileum. Exploratory laparotomy with reduction of ileocolic anastomosis and small bowel resection. Seen in ER with 3 day history of URI like symptoms. Lethargic after receiving anti-histamine. Nausea and vomiting. Diminished appetite and urine output. Low grade temperature. Weight loss. Dehydration. Drowsiness secondary to possible antihistamine overdose.
Age: 0.2
Sex: M
Vaccine: RV5, RV5
Symptoms: Apnoea, Chest X-ray normal, Heart rate, Oxygen saturation, Respiratory arrest
Clinical narrative: Information has been received from a physician and a nurse concerning a 9 week old (8lb., 15 oz.) male with gastroesophageal reflux and prematurity with apnea and bradycardia (on monitor when sleeping) who on 19-MAR-2008 was vaccinated PO with his first 2.0 ml dose of ROTATEQ (lot# 657980/0106K). There were no concomitant vaccinations. Concomitant drug therapy included PREVACID and ZANTAC. Upon vaccination, the patient "Stopped breathing." The patient sought medical attention in the physician's office. Lab diagnostic studies included a chest x-ray that was within normal limits, a heart rate which was 44-150 bpm and oxygen saturation results of 98-99% room air. The patient was also treated by stimulation and the patient was suctioned with a bulb syringe. It was noted that therapy with ROTATEQ was discontinued for the second and third dose. Subsequently, the patient recovered. There was no product quality complaint. Stopped breathing was considered to be immediately life-threatening by the physician. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5, RV5
Symptoms: Breath sounds abnormal, Chest X-ray, Dysphagia, Intercostal retraction, Oxygen saturation
Clinical narrative: Information has been received from a physician and a nurse concerning a 9 week old (8lb., 15 oz.) male with gastroesophageal reflux and prematurity with apnea and bradycardia (on monitor when sleeping) who on 19-MAR-2008 was vaccinated PO with his first 2.0 ml dose of ROTATEQ (lot# 657980/0106K). There were no concomitant vaccinations. Concomitant drug therapy included PREVACID and ZANTAC. Upon vaccination, the patient "Stopped breathing." The patient sought medical attention in the physician's office. Lab diagnostic studies included a chest x-ray that was within normal limits, a heart rate which was 44-150 bpm and oxygen saturation results of 98-99% room air. The patient was also treated by stimulation and the patient was suctioned with a bulb syringe. It was noted that therapy with ROTATEQ was discontinued for the second and third dose. Subsequently, the patient recovered. There was no product quality complaint. Stopped breathing was considered to be immediately life-threatening by the physician. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5, RV5
Symptoms: Respiratory arrest
Clinical narrative: Information has been received from a physician and a nurse concerning a 9 week old (8lb., 15 oz.) male with gastroesophageal reflux and prematurity with apnea and bradycardia (on monitor when sleeping) who on 19-MAR-2008 was vaccinated PO with his first 2.0 ml dose of ROTATEQ (lot# 657980/0106K). There were no concomitant vaccinations. Concomitant drug therapy included PREVACID and ZANTAC. Upon vaccination, the patient "Stopped breathing." The patient sought medical attention in the physician's office. Lab diagnostic studies included a chest x-ray that was within normal limits, a heart rate which was 44-150 bpm and oxygen saturation results of 98-99% room air. The patient was also treated by stimulation and the patient was suctioned with a bulb syringe. It was noted that therapy with ROTATEQ was discontinued for the second and third dose. Subsequently, the patient recovered. There was no product quality complaint. Stopped breathing was considered to be immediately life-threatening by the physician. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV, RV5
Symptoms: Haematochezia, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a 20 week old (breast-fed) female with gastroesophageal reflux disease (GERD) and potential milk protein allergy (milk intolerance while breast feeding) and a history of umbilical hernia, gas and irritability who on 11-JAN-2008 and 14-MAR-2008 (also reported as 21-MAR-2008) was vaccinated PO with her first and second doses of Rotateq (lot# 657667/1392U, 656841/1319U).  Concomitant vaccinations administered on 14-MAR-2008 included a dose of PEDIARIX, a dose of Pneumovax 23 (manufacturer unknown) and a dose of ACTHIB.  On 15-MAR-2008 (also reported as 22-MAR-2008) the day after vaccination, the patient experienced bloody stools which resolved without intervention.  No other symptoms were noted.  The patient sought unspecified medical attention (method unknown).  No labs or diagnostic studies were performed.  The patient was not hospitalized.  On 23-MAR-2008 the patient recovered.  There was no product quality complaint.  Upon internal review, bloody stool was determined to be an other important medical event.  Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Joint effusion, Joint swelling
Clinical narrative: Initial report received on 01 April 2008 from a nurse.  A 5-year-old male patient, who had concurrent illness of "strep" infection (diagnosed 17 March 2008) that was being treated with amoxicillin, Tylenol, and Motrin, had received on 19 March 2008 a fifth, intramuscular, left anterior thigh injection of Tripedia (lot # C2797AA); a third, subcutaneous, right anterior thigh injection of IPOL (lot # A0298-2); a first, subcutaneous, left anterior thigh injection of "MMR" (Measles Mumps Rubella Virus vaccine) (Manufacturer Merck, lot # 1670U); and a first, subcutaneous, right anterior thigh injection of Varivax (manufacturer Merck, lot # 1788U).  The following day, the patient developed redness and swelling of the left thigh and knee.  He was taken to the emergency room and admitted to the hospital for "1-2 days" where he was diagnosed with cellulitis and joint effusion.  The patient received corrective treatment of intravenous antibiotics (specific antibiotics were not specified).  Diagnostic testings performed were not provided.  As of 01 April 2008, the symptoms had resolved.  The patient recovered.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Childhood disintegrative disorder, Developmental delay, Regressive behaviour, Speech disorder
Clinical narrative: Pt started to regress in development. Stopped hitting milestone at 9 mo. of age.  4/8/08 Case closed w/records attached to VAERS report by parents. FINAL DX: autism (high functioning) Psychiatric evaluation of 2003: Parents noted significant developmental issues at 9 mo of age when he was not crawling or sitting up.  Began crawling 17 mo.  Began single words at 3 yrs old.  Very loud speech & using nonsense words.  Delay in toilet training, fine & gross motor skills.  Enrolled in early intervention program at 18 mo for ST/OT/PT & developmental teacher.  Agressive behavior w/others & poor social skills.  Plays alone or parallel play.  Poor eye contact.  Resists change.  Temper tantrums.  Poor attention span unless involved in repetitive/sterotypical behaviors.  Hyperactive.  Separation anxiety & fear of dogs.   1/21/2010 Child has autism, low muscle bone. Follow-up: (He has social problems along with a list of other related problems. I believe because patient has a weak immune system when he was born he received to many vaccines to soon.) Patient is a 9 year old boy who has had speech, occ therapy, physical therapy, and has many developmental problems. He has received these services since he was 18 months old. Because of his vaccines he has been robbed of his childhood and his future is uncertain.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Body temperature, Fatigue, Full blood count normal, Headache, Nausea
Clinical narrative: Vaccines admin. 4-1-08, that night pt. c/o soreness of arms.  4-2-08 very tired, achy.  4-3-08 L arm quivering, achy, soreness, nausea and headache.  4-4-08 headache, jaw pain, low grade temp 100.  Pt. stated head is "splitting".  Prone to headaches.  Rx with Imitrex.  hx mono 9-07.  Lab ordered CBC, sed rate.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pain, Pain in extremity, Pain in jaw, Red blood cell sedimentation rate normal, Tremor
Clinical narrative: Vaccines admin. 4-1-08, that night pt. c/o soreness of arms.  4-2-08 very tired, achy.  4-3-08 L arm quivering, achy, soreness, nausea and headache.  4-4-08 headache, jaw pain, low grade temp 100.  Pt. stated head is "splitting".  Prone to headaches.  Rx with Imitrex.  hx mono 9-07.  Lab ordered CBC, sed rate.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Vaccine positive rechallenge
Clinical narrative: Approx. 15 min after receiving the vaccine, the client experienced numbness in her fingertips and her two fingers on the outer side of her rt hand.  The mother was contacted the next day and she stated that this lasted all night; in the morning the client was fine.  The client received her 1st dose of HPV on Jan 15, 2008, the mother stated that after that dose her left hand was numb for several hrs but then resolved itself.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Face and mouth X-ray abnormal, Facial bones fracture, Fall, Syncope
Clinical narrative: Pt received imm inj per protocol, bandage was applied + clothing covered arm.  Pt was sitting on exam table and talking after injection.  Mother was in the room.  Pt touched left deltoid approx 1 1/2 minutes, nurse disposing sharps when pt fainted & fell striking nose.  Xray revealed nasal Fx, ENT consulted with splint.
Age: 1.6
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Body temperature, Rash, Rash erythematous
Clinical narrative: Low grade temp of 99 degrees x 1 day & red rash on trunk of body.  Occurrence developed 12 days after immunizations administered.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Hives, difficulty breathing after 24 hrs. after Menactra shot given.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Body temperature, Diarrhoea, Vomiting, Yellow skin
Clinical narrative: Mom reports patient became ill during noc with 100 degree temp.  Stomach, emesis with yellow bile & yellow skin, loose stool.  Continues with above c/o this morning.  Referred to MD.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration
Clinical narrative: Child had a 6" x 4" discoloration on R leg, induration of 2" surrounding injection site and the rest was redness.  Immunizations given on 4-2-08, on 4-3-08 redness was quarter sized, on 4-4-08 had gotten bigger.  Milder, Augmentin, Prelone.  No fever.
Age: 5.0
Sex: U
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Right arm red, edematous, tender, warm to touch.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Induration, Injection site erythema, Injection site swelling
Clinical narrative: Swollen, erythematous L upper arm.  Erythema measuring 13.5 x 10 cm.  Mild induration approx. 5 x 5 cm area.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Eye irritation, Rash macular
Clinical narrative: Custodial parent stated after Hep A vaccine on 9-14-07, taken to ER on 9/15/07 for blotchy rash.  Eyes looked like pink eye.  ER gave script for prednisone & eye drops.
Age: 1.1
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Allergy test, Urticaria
Clinical narrative: child received vaccination 3/18/08 (MMR Varivax, Hepatitis A). I saw her in the office on 3/27/08 with diffuse marked urticaria. Mom reported that the rash started on the day after he received his vaccines (within 48 hrs) and has continued so she brought him in.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Erythema, Erythema multiforme, Pruritus, Urticaria
Clinical narrative: Hives noticed about 6 hr. after shots.  Pediapred prescribed for 7 days bid.  Also Benadryl 1 tsp. every 4-6 hr., & Zyrtec 1 tsp. daily for itching.  The patient is a 1-year-old female came in yesterday and had her 1 year immunizations.  Last night at her bath time dad noticed a couple of red spots.  This morning when she woke up she was covered with hives.  She has been scratching at them a little bit.  She has not had a fever and she has otherwise seemed fine.  Erythema multiforme secondary to one of the vaccines she received yesterday most likely, which include MMR, varicella, hepatitis A, and Prevnar, which is less likely because that was her third dose.  She will be placed on Pediapred 30 mg initially, 10 mg tonight at bedtime, then 20 mg b.i.d. for 2 days, 10 mg b.i.d. for 2 days, then 5 mg b.i.d. for 2 days.  Also it is recommended that she get some Benadryl today, 1 teaspoon every 4-6 hours and they also could try Zyrtec 1 teaspoon daily until her itching is diminished.  They will return with increasing symptoms or as needed.  She should not receive any of the above vaccines again.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Blister, Injection site bruising, Injection site erythema, Injection site induration, Pruritus
Clinical narrative: Pt recieved smallpox vaccination on 3/38/08.  On 4/4/08, pt returned for his 7 day follow up with a regular reaction:  white vesicle 5mm, local itching, and local redness.  On day 4/6/08, pt presented with a large erythemic smallpox site of 40x40mm induration.  Site has purplish bruising of 40x40mm, local rash, and 5mm white vesicle.  Pt reported adverse reaction to medical 4/7/0804.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Rash
Clinical narrative: Pt recieved smallpox vaccination on 3/38/08.  On 4/4/08, pt returned for his 7 day follow up with a regular reaction:  white vesicle 5mm, local itching, and local redness.  On day 4/6/08, pt presented with a large erythemic smallpox site of 40x40mm induration.  Site has purplish bruising of 40x40mm, local rash, and 5mm white vesicle.  Pt reported adverse reaction to medical 4/7/0804.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Swelling with warmth to injection site.  Upper left arm swelled about 5 cm noticed 24 hours after injection of varicella.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Vaccine positive rechallenge
Clinical narrative: Pt fainted after receiving second dose of Gardasil.  This also occurred after the first dose given with Menactra 11/16/07.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL, HEPA, HPV4, VARCEL
Symptoms: Chest pain, Heart rate irregular, Hypotension
Clinical narrative: Client was given 3 vaccines (Hep A, Varicella and Gardasil) and within 10 minutes of administration, the client began complaining of chest pain. Assisted to a supine position. BP was 78/20 and pulse was erratic and nurse not able to count.  EMS was called.  Client remained conscious. BP was 128/90, HR 100 when she left with EMS.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL, HEPA, HPV4, VARCEL
Symptoms: Chest pain, Condition aggravated, Nuclear magnetic resonance imaging normal, Syncope
Clinical narrative: Client was given 3 vaccines (Hep A, Varicella and Gardasil) and within 10 minutes of administration, the client began complaining of chest pain. Assisted to a supine position. BP was 78/20 and pulse was erratic and nurse not able to count.  EMS was called.  Client remained conscious. BP was 128/90, HR 100 when she left with EMS.
Age: 22.0
Sex: F
Vaccine: ANTH
Symptoms: Dizziness, Headache, Injection site erythema, Injection site inflammation, Malaise
Clinical narrative: Headache, dizziness, general sick feeling, nausea, redness and inflammation at injection site, itching.
Age: 22.0
Sex: F
Vaccine: ANTH
Symptoms: Nausea, Pruritus
Clinical narrative: Headache, dizziness, general sick feeling, nausea, redness and inflammation at injection site, itching.
Age: 25.0
Sex: U
Vaccine: ANTH, MNQ, TYP
Symptoms: Headache, Injection site erythema, Injection site inflammation, Injection site irritation, Injection site pain
Clinical narrative: Severe headaches for 3 days.  Burning and achiness at and around injection site.  Measured at 2 1/2 inches in diameter.  Redness, hot, and inflammed at site.  Like a welt.
Age: 25.0
Sex: U
Vaccine: ANTH, MNQ, TYP
Symptoms: Injection site warmth, Urticaria
Clinical narrative: Severe headaches for 3 days.  Burning and achiness at and around injection site.  Measured at 2 1/2 inches in diameter.  Redness, hot, and inflammed at site.  Like a welt.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Abnormal behaviour, Appetite disorder, Pollakiuria, Thirst, Type 1 diabetes mellitus
Clinical narrative: At the end of January '08 beginning of February '08 patient started having frequent urination and increased thirst.  These symptoms progressively got worse over the next weeks.  He had behavioral changes and had excessive hunger also.  We took him to the doctor on February 22nd '08 and they diagnosed him with Type 1 Diabetes and sent us straight to the hospital.  We were admitted and stayed there for 3days.  6/12/08-records received for DOS 2/22-2/24/08-DC DX: Diabetes Mellitus. Follow-up: He now has an uncurable disease that requires 4-6 finger sticks per day and 3-4 shots. His blood sugars remain to be high and low and he requires frequent dr visits. He requires monitoring 24/7. Our lives have been changed forever b/c of this. Shame on the government for forcing vaccinations that not only are not safe but PROVEN to cause this disease. The package insert states diabetes as a side effect. My informed consent consisted of telling me side effects were only mild irritation at the site of injection, mild fever or irritability. Some "informed" consent! Quite forcing vaccinations without proper consent and that will solve your problem.
Age: 0.53
Sex: F
Vaccine: 6VAX-F, FLU3, PNC, RV5
Symptoms: Convulsion, Influenza serology, Pyrexia, Respiratory syncytial virus serology, Urine analysis
Clinical narrative: Pt was given Pediarix #3, Prevnar #3 and Rotavirus #3 on 2-11-08. Parent states the child got a high fever and had a siezure.  The parent took the child to Hospital.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Cough, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt developed redness, swelling and pain at site of varicella vaccine same day.  Morning after vaccines given pt had headache, fever and vomiting and later developed runny/stuffy nose and cough.  Mother took patient to Urgent Care and told Staph infection and started on Bactrim DS.  Follow up dx 4 days later with me, vaccine administering provider:  No redness, mild swelling and mild pain at Var injection site, pt with cold symptoms and not yet fully recovered as of 4/7/08.  It is my professional opinion that this was not a Staph infection but a combination of a new onset upper respiratory infection and localized reaction to Var vaccine.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Local reaction, Nasal congestion, Pyrexia, Rhinorrhoea, Staphylococcal infection
Clinical narrative: Pt developed redness, swelling and pain at site of varicella vaccine same day.  Morning after vaccines given pt had headache, fever and vomiting and later developed runny/stuffy nose and cough.  Mother took patient to Urgent Care and told Staph infection and started on Bactrim DS.  Follow up dx 4 days later with me, vaccine administering provider:  No redness, mild swelling and mild pain at Var injection site, pt with cold symptoms and not yet fully recovered as of 4/7/08.  It is my professional opinion that this was not a Staph infection but a combination of a new onset upper respiratory infection and localized reaction to Var vaccine.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Upper respiratory tract infection, Vomiting
Clinical narrative: Pt developed redness, swelling and pain at site of varicella vaccine same day.  Morning after vaccines given pt had headache, fever and vomiting and later developed runny/stuffy nose and cough.  Mother took patient to Urgent Care and told Staph infection and started on Bactrim DS.  Follow up dx 4 days later with me, vaccine administering provider:  No redness, mild swelling and mild pain at Var injection site, pt with cold symptoms and not yet fully recovered as of 4/7/08.  It is my professional opinion that this was not a Staph infection but a combination of a new onset upper respiratory infection and localized reaction to Var vaccine.
Age: 23.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Skin lesion
Clinical narrative: Multiple lesions on L shoulder (1.5 cm and .5 cm) and one lesion on L cheek (1.5 cm). Possible lesion beginning on R cheek. No other lesions noted on body. No recent illnesses.
Age: 23.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Central nervous system lesion, Computerised tomogram abnormal, Hypoaesthesia, Multiple sclerosis, Muscular weakness
Clinical narrative: Numbness starting in right ankle to knee and hip area. Hospital performed sensation tests and after CT and MRI discovered multiple leasions on brain and spine.  4/24/2008 MR received for neuro consults beginning 12/21/2007 to 4/2/2008 with DX: Multiple sclerosis and Optic Neuritis. Pt developed numbness in R foot in October 2007 which progressed into the R trunk and R arm.  Weakness of the R arm resulted in pt dropping things. Two weeks later pt noted blurred vision in the L eye, associated with some mild pressure and pain with movement of the eye and unable to read.  Brain and cervical MRIs were c/w dx of MS. 6 weeks after onset pt noted unsteadiness on feet and emesis. (+) Urinary frequency and urgency as well as fatigue.  Initial PE (+) for optic pallor, weakness in R wrist, diminished pinprick and sensation in R forearm and hand.  Initally txd with Prednisone. Vision deterioration noted 12/26/07. Improved with Solumedrol. (+) Depression r/t medical condition etc.  Clinically stable 4/2008. Follow-up: I have MS, Optic Neuritis (Loss of Vision), Spine burns, legs numb, wear diapers sometimes due to problems there.
Age: 23.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain abnormal, Optic atrophy, Visual acuity reduced
Clinical narrative: Numbness starting in right ankle to knee and hip area. Hospital performed sensation tests and after CT and MRI discovered multiple leasions on brain and spine.  4/24/2008 MR received for neuro consults beginning 12/21/2007 to 4/2/2008 with DX: Multiple sclerosis and Optic Neuritis. Pt developed numbness in R foot in October 2007 which progressed into the R trunk and R arm.  Weakness of the R arm resulted in pt dropping things. Two weeks later pt noted blurred vision in the L eye, associated with some mild pressure and pain with movement of the eye and unable to read.  Brain and cervical MRIs were c/w dx of MS. 6 weeks after onset pt noted unsteadiness on feet and emesis. (+) Urinary frequency and urgency as well as fatigue.  Initial PE (+) for optic pallor, weakness in R wrist, diminished pinprick and sensation in R forearm and hand.  Initally txd with Prednisone. Vision deterioration noted 12/26/07. Improved with Solumedrol. (+) Depression r/t medical condition etc.  Clinically stable 4/2008. Follow-up: I have MS, Optic Neuritis (Loss of Vision), Spine burns, legs numb, wear diapers sometimes due to problems there.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Patient was seen on Monday and by that night mother noted a redden area in right upper arm but did not give her any Tylenol at that time. It continued to enlarge and remain red and tender so mother brought her in on Wednesday. The child had a large area of inflammation at injection site: 15x20cm's, warm and firm. Child had no other signs of secondary infection; no fever, pustules or systemic symptoms. Benadryl was prescribed as well as Tylenol for the discomfort. The child had a return appointment which indicated the reaction was resolving without incidence.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema nodosum
Clinical narrative: 7 Aug 2004 patient was treated for Erythema Nodosum.  This condition manifested 6 days after immunization with Anthrax Vaccine.  Per patient this was the second episode, but was unable to correlate for episode with anthrax immunization prior to. Submitting this report per patients request.
Age: 70.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Flushing, Nausea, Oedema peripheral, Pruritus
Clinical narrative: Nausea, feverish, throat tightness, itching, painful joint, arm swelling, flushed.
Age: 70.0
Sex: F
Vaccine: TD
Symptoms: Pyrexia, Throat tightness
Clinical narrative: Nausea, feverish, throat tightness, itching, painful joint, arm swelling, flushed.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, and hot at injection site along with left cheek redness at approximately 7:00 pm each evening.
Age: 14.0
Sex: M
Vaccine: TD
Symptoms: Body temperature increased, Pain, Vomiting
Clinical narrative: 4 hours after the tetanus shot was given he had extreme aching and vomiting for 48 hours, temperature was 101.