chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Laboratory test, Musculoskeletal pain, Pain in extremity
Clinical narrative: Pain in back of both legs, rt wrist started 6-26-07. Pain with rt wrist radiates to 3rd and 4th fingers. Pain at lt shoulder since 3-07. Tried exercises and Motrin - no help. Saw ortho - had steroid injection. Stopped Crestor, notes Naproxen and Lymca with some relief.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure normal, Dizziness, Heart rate normal, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: pt felt faint and passed out immediately after injection, approx 5 sec. 10:15 am BP 117/65 P: 59 O2 Sat 100% 10:16 BP 102/58 P: 74 O2 Sat 100:-Juice given once 10:20 BP 108/68 P: 70 O2 Sat 1005-pt allowed to sit up 10:25 BP 103/68 P: 80 O2 Sat 100% 10:30 BP 96/66 P: 72 O2 Sat 100%
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Oxygen saturation normal
Clinical narrative: pt felt faint and passed out immediately after injection, approx 5 sec. 10:15 am BP 117/65 P: 59 O2 Sat 100% 10:16 BP 102/58 P: 74 O2 Sat 100:-Juice given once 10:20 BP 108/68 P: 70 O2 Sat 1005-pt allowed to sit up 10:25 BP 103/68 P: 80 O2 Sat 100% 10:30 BP 96/66 P: 72 O2 Sat 100%
Age: 45.0
Sex: M
Vaccine: ANTH
Symptoms: Balance disorder, Blood pressure increased, Dizziness, Feeling jittery, Nasopharyngitis
Clinical narrative: Received 1st shot 31 Mar, 2nd on 14 Apr, on 15 Apr woke up wide awake about 0300 hrs, unable to sleep, slept about 4 hrs the night of the 16th, very jittery, felt like he "took 10 Sudafed", dizzy, off balance, cold symptoms, increased BP on 23 Apr.
Age: 45.0
Sex: M
Vaccine: ANTH
Symptoms: Sleep disorder
Clinical narrative: Received 1st shot 31 Mar, 2nd on 14 Apr, on 15 Apr woke up wide awake about 0300 hrs, unable to sleep, slept about 4 hrs the night of the 16th, very jittery, felt like he "took 10 Sudafed", dizzy, off balance, cold symptoms, increased BP on 23 Apr.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: On 8-23-07 Mother brought her daughter for more vaccines that weren't available on 8-21-07. Mom showed nurse pt's (L) arm which was red and swollen from last shots receive on 8-21-07.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia, Urticaria
Clinical narrative: 8/22/07-Fever of 102-103 deg-started at 11pm Fever continued of 101-102 through 8/26/07 8/24/07-Hives over 90% of body at 7am Saw physician-Still has hives on 8/27
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Induration, Pain, Pruritus, Pyrexia
Clinical narrative: Began with local swelling, itching and pain 1 day after immunization. Fever x 1d. On exam area was red, hot, tender, indurated - treated with Keflex for cellulitis.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin warm, Swelling, Tenderness
Clinical narrative: Began with local swelling, itching and pain 1 day after immunization. Fever x 1d. On exam area was red, hot, tender, indurated - treated with Keflex for cellulitis.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling and pain at injection site (R) deltoid. Advised OTC Motrin/ice pack.
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Burning sensation, Erythema, Pain, Pruritus, Swelling
Clinical narrative: Swelling, reddening of upper arm, intense pain and itchiness of skin w/burning sensation redness and swelling spread to elbow area.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Pt returned to office one day later with left upper arm red, swollen, warm to touch, and painful. Afebrile.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, HIBV, IPV, PNC
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Body temperature increased
Clinical narrative: Temp 102.5 w/i 24 hours of vaccine.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Hypersensitivity, Injection site erythema
Clinical narrative: Possible allergic rx 5-6 cm erythema at DTaP site.
Age: 0.38
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Body temperature increased
Clinical narrative: Temp 102.8 24 hours post immunization.
Age: 12.0
Sex: M
Vaccine: HEPA
Symptoms: Burning sensation, Chills, Evans syndrome, Injection site pain
Clinical narrative: Onset of chills and fever (101.7). Parents dosing with Advil - injection site soreness c/o "burning in chest".
Age: 0.76
Sex: F
Vaccine: HEP
Symptoms: Kawasaki's disease
Clinical narrative: child admitted to CHOC dx with Kawasaki Disease on 7/10/2007. 10/29/07-records received for DOS 07/10-07/13/07-DC DX: Kawasaki disease. Seen in ER temperature 104.4,  Admitted with fever, rash and swollen extremities, chapped lips, decreased oral intake began last Friday. Conjuctivial injection bilaterally,  Treated with IVIG.
Age: 1.1
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Child seen right after immunization series for a rash that presented 11 days after MMR vacc. Rash began on face and has traveled to trunk and UE/LE. Child does scratch. No fever. No decrease in appetite. No difficulty breathing. Twin brother with same vaccine with same problems. Rash began 24 hours after day at park where child had sunscreen on and exposed to water at theme park. Mom has given 3 doses of Benadryl with resolution of sx.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site erythema
Clinical narrative: Mild erythema to immunization site about 5 mm to (R) upper leg.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, pain at site of injection (L deltoid/upper arm). 5 1/2cm down upper arm and 5 1/2. Ibuprofen 1 1/2 tsp Q 8 hours, Orapred 30mg x 5 d.
Age: 0.2
Sex: F
Vaccine: HEPA
Symptoms: Wrong drug administered
Clinical narrative: Hepatitis A given at 2 months old by mistake. Needed Hepatitis B #2.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral, Pyrexia
Clinical narrative: Vaccine given in left arm 8/28/07. Fever of 103 within 24 hours, swelling 14x14cm area with erythema on the left arm. Interventions Benadryl and Tylenol - swelling g x 5 days.
Age: 16.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: Pt was given DTaP instead of Tdap. No symptoms within 24 hours.
Age: 5.0
Sex: F
Vaccine: UNK
Symptoms: Hyperaesthesia, Injection site erythema, Injection site vesicles, Pyrexia
Clinical narrative: Fever to 101, large erythema at vaccine site with single vesicle and pain to touch. Erythema measuring 10x8 inches.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Intussusception, Obstruction, Pyrexia, Small intestinal resection
Clinical narrative: Information has been received from an agency concerning a 14 week old female, who was noted to have birth defects of a grossly deformed right ear and a spot on her kidney, who on 07-MAY-2007 was vaccinated with a first dose of Rotateq (Lot # 656383/0235U). Concomitant vaccines included a first dose of Pediarix (Lot# AC21B114BB), a first dose of ActHib (Lot# UF018AA) and a first dose of Prevnar (Lot# B08692D). On 30-MAY-2007 the patient experienced nausea, bilious vomiting, fever, and lethargy for four days. The patient was admitted from 30-MAY-2007 to 03-JUN-2007. The patient was treated with IV antibiotics and was taken to the operating room. A small bowel intussusception was found a the proximal mid ileum. On 01-JUN-2007 the patient had a resection of five cm of the bowel. The patient did well post operation without complications. The final diagnosis was intussusception, and the patient had an exploratory laparotomy and small bowel reaction with reanastomosis. It was reported that the patient recovered. The patient's experience was considered to be immediately life-threatening by the reporter. A lot check was requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements and was released. Additional information is not expected.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from an agency concerning a 14 week old female, who was noted to have birth defects of a grossly deformed right ear and a spot on her kidney, who on 07-MAY-2007 was vaccinated with a first dose of Rotateq (Lot # 656383/0235U). Concomitant vaccines included a first dose of Pediarix (Lot# AC21B114BB), a first dose of ActHib (Lot# UF018AA) and a first dose of Prevnar (Lot# B08692D). On 30-MAY-2007 the patient experienced nausea, bilious vomiting, fever, and lethargy for four days. The patient was admitted from 30-MAY-2007 to 03-JUN-2007. The patient was treated with IV antibiotics and was taken to the operating room. A small bowel intussusception was found a the proximal mid ileum. On 01-JUN-2007 the patient had a resection of five cm of the bowel. The patient did well post operation without complications. The final diagnosis was intussusception, and the patient had an exploratory laparotomy and small bowel reaction with reanastomosis. It was reported that the patient recovered. The patient's experience was considered to be immediately life-threatening by the reporter. A lot check was requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements and was released. Additional information is not expected.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from an agency concerning a 14 week old female, who was noted to have birth defects of a grossly deformed right ear and a spot on her kidney, who on 07-MAY-2007 was vaccinated with a first dose of Rotateq (Lot # 656383/0235U). Concomitant vaccines included a first dose of Pediarix (Lot# AC21B114BB), a first dose of ActHib (Lot# UF018AA) and a first dose of Prevnar (Lot# B08692D). On 30-MAY-2007 the patient experienced nausea, bilious vomiting, fever, and lethargy for four days. The patient was admitted from 30-MAY-2007 to 03-JUN-2007. The patient was treated with IV antibiotics and was taken to the operating room. A small bowel intussusception was found a the proximal mid ileum. On 01-JUN-2007 the patient had a resection of five cm of the bowel. The patient did well post operation without complications. The final diagnosis was intussusception, and the patient had an exploratory laparotomy and small bowel reaction with reanastomosis. It was reported that the patient recovered. The patient's experience was considered to be immediately life-threatening by the reporter. A lot check was requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements and was released. Additional information is not expected.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Blood potassium increased, Blood sodium decreased, Blood urea normal, Intussusception
Clinical narrative: Information has been received from an agency concerning a 14 week old female, who was noted to have birth defects of a grossly deformed right ear and a spot on her kidney, who on 07-MAY-2007 was vaccinated with a first dose of Rotateq (Lot # 656383/0235U). Concomitant vaccines included a first dose of Pediarix (Lot# AC21B114BB), a first dose of ActHib (Lot# UF018AA) and a first dose of Prevnar (Lot# B08692D). On 30-MAY-2007 the patient experienced nausea, bilious vomiting, fever, and lethargy for four days. The patient was admitted from 30-MAY-2007 to 03-JUN-2007. The patient was treated with IV antibiotics and was taken to the operating room. A small bowel intussusception was found a the proximal mid ileum. On 01-JUN-2007 the patient had a resection of five cm of the bowel. The patient did well post operation without complications. The final diagnosis was intussusception, and the patient had an exploratory laparotomy and small bowel reaction with reanastomosis. It was reported that the patient recovered. The patient's experience was considered to be immediately life-threatening by the reporter. A lot check was requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements and was released. Additional information is not expected.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Laparotomy, Lethargy, Nausea, Obstruction, Pyrexia
Clinical narrative: Information has been received from an agency concerning a 14 week old female, who was noted to have birth defects of a grossly deformed right ear and a spot on her kidney, who on 07-MAY-2007 was vaccinated with a first dose of Rotateq (Lot # 656383/0235U). Concomitant vaccines included a first dose of Pediarix (Lot# AC21B114BB), a first dose of ActHib (Lot# UF018AA) and a first dose of Prevnar (Lot# B08692D). On 30-MAY-2007 the patient experienced nausea, bilious vomiting, fever, and lethargy for four days. The patient was admitted from 30-MAY-2007 to 03-JUN-2007. The patient was treated with IV antibiotics and was taken to the operating room. A small bowel intussusception was found a the proximal mid ileum. On 01-JUN-2007 the patient had a resection of five cm of the bowel. The patient did well post operation without complications. The final diagnosis was intussusception, and the patient had an exploratory laparotomy and small bowel reaction with reanastomosis. It was reported that the patient recovered. The patient's experience was considered to be immediately life-threatening by the reporter. A lot check was requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements and was released. Additional information is not expected.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Small intestinal anastomosis, Small intestinal resection, Surgery, Urinary system X-ray, Vomiting
Clinical narrative: Information has been received from an agency concerning a 14 week old female, who was noted to have birth defects of a grossly deformed right ear and a spot on her kidney, who on 07-MAY-2007 was vaccinated with a first dose of Rotateq (Lot # 656383/0235U). Concomitant vaccines included a first dose of Pediarix (Lot# AC21B114BB), a first dose of ActHib (Lot# UF018AA) and a first dose of Prevnar (Lot# B08692D). On 30-MAY-2007 the patient experienced nausea, bilious vomiting, fever, and lethargy for four days. The patient was admitted from 30-MAY-2007 to 03-JUN-2007. The patient was treated with IV antibiotics and was taken to the operating room. A small bowel intussusception was found a the proximal mid ileum. On 01-JUN-2007 the patient had a resection of five cm of the bowel. The patient did well post operation without complications. The final diagnosis was intussusception, and the patient had an exploratory laparotomy and small bowel reaction with reanastomosis. It was reported that the patient recovered. The patient's experience was considered to be immediately life-threatening by the reporter. A lot check was requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements and was released. Additional information is not expected.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: White blood cell count increased
Clinical narrative: Information has been received from an agency concerning a 14 week old female, who was noted to have birth defects of a grossly deformed right ear and a spot on her kidney, who on 07-MAY-2007 was vaccinated with a first dose of Rotateq (Lot # 656383/0235U). Concomitant vaccines included a first dose of Pediarix (Lot# AC21B114BB), a first dose of ActHib (Lot# UF018AA) and a first dose of Prevnar (Lot# B08692D). On 30-MAY-2007 the patient experienced nausea, bilious vomiting, fever, and lethargy for four days. The patient was admitted from 30-MAY-2007 to 03-JUN-2007. The patient was treated with IV antibiotics and was taken to the operating room. A small bowel intussusception was found a the proximal mid ileum. On 01-JUN-2007 the patient had a resection of five cm of the bowel. The patient did well post operation without complications. The final diagnosis was intussusception, and the patient had an exploratory laparotomy and small bowel reaction with reanastomosis. It was reported that the patient recovered. The patient's experience was considered to be immediately life-threatening by the reporter. A lot check was requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements and was released. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fall, Head injury, Loss of consciousness
Clinical narrative: Information was obtained on request by the Company from the FDA under the Freedom of Information Act concerning an 18 year old female patient who on 14-JUN-2007 was vaccinated IM with a dose of Gardasil, lot #658094/0524U. Shortly after, the patient blacked out and fell off exam table where she had been sitting. Her forehead struck the exam table stirrup, breaking it off, her left thigh scraped against broken metal from stirrup and patient landed on the floor, where she was found by the nurse. Her outcome was not reported. The reporter considered loss of consciousness, head injury and fall to be immediately life-threatening. The original reporting source was not provided. A standard lot check was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements and was released. No further information is available.
Age: 0.4
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from the FDA (VAERS # 284308) through the CDC concerning a 23-week-old male with a ventricular septal defect and a cardiac murmur and a history of bronchitis and pyloric stenosis (surgically repaired) who on 07-JUN-2007 was vaccinated with a second dose of Rotateq (Lot # "0578E"). Concomitant therapy that day included a second dose of DAPTACEL (Lot # C2650AA), a dose of COMVAX (Lot # Z0547), and a second dose of PREVNAR (Lot # B0674A). It was noted that on 30-JUN-2007, the patient complained of fever, nausea, and vomiting since the night before. The sudden onset of vomiting became projectile. The patient was noted to have bloody diarrhea and a temperature of 100.5. On 30-JUN-2007, 23 days post vaccination, the patient was diagnosed with intussusception and was hospitalized. An exploratory laparotomy and appendectomy were done on 02-JUL-2007. Lab values included: neutrophils=71.1; monocytes=2.9; potassium=2.0; sodium=147; urine culture=no growth; stool culture=normal flora; x-ray upper GI with KUB=distended small bowel loops compatible with small bowel obstruction. The patient was discharged on 07-JUL-2007. The outcome was recovered. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Appendicectomy, Blood potassium decreased, Blood sodium normal, Culture stool negative, Culture urine negative
Clinical narrative: Information has been received from the FDA (VAERS # 284308) through the CDC concerning a 23-week-old male with a ventricular septal defect and a cardiac murmur and a history of bronchitis and pyloric stenosis (surgically repaired) who on 07-JUN-2007 was vaccinated with a second dose of Rotateq (Lot # "0578E"). Concomitant therapy that day included a second dose of DAPTACEL (Lot # C2650AA), a dose of COMVAX (Lot # Z0547), and a second dose of PREVNAR (Lot # B0674A). It was noted that on 30-JUN-2007, the patient complained of fever, nausea, and vomiting since the night before. The sudden onset of vomiting became projectile. The patient was noted to have bloody diarrhea and a temperature of 100.5. On 30-JUN-2007, 23 days post vaccination, the patient was diagnosed with intussusception and was hospitalized. An exploratory laparotomy and appendectomy were done on 02-JUL-2007. Lab values included: neutrophils=71.1; monocytes=2.9; potassium=2.0; sodium=147; urine culture=no growth; stool culture=normal flora; x-ray upper GI with KUB=distended small bowel loops compatible with small bowel obstruction. The patient was discharged on 07-JUL-2007. The outcome was recovered. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Diarrhoea haemorrhagic, Explorative laparotomy, Intussusception, Lymphocyte count normal, Monocyte count normal
Clinical narrative: Information has been received from the FDA (VAERS # 284308) through the CDC concerning a 23-week-old male with a ventricular septal defect and a cardiac murmur and a history of bronchitis and pyloric stenosis (surgically repaired) who on 07-JUN-2007 was vaccinated with a second dose of Rotateq (Lot # "0578E"). Concomitant therapy that day included a second dose of DAPTACEL (Lot # C2650AA), a dose of COMVAX (Lot # Z0547), and a second dose of PREVNAR (Lot # B0674A). It was noted that on 30-JUN-2007, the patient complained of fever, nausea, and vomiting since the night before. The sudden onset of vomiting became projectile. The patient was noted to have bloody diarrhea and a temperature of 100.5. On 30-JUN-2007, 23 days post vaccination, the patient was diagnosed with intussusception and was hospitalized. An exploratory laparotomy and appendectomy were done on 02-JUL-2007. Lab values included: neutrophils=71.1; monocytes=2.9; potassium=2.0; sodium=147; urine culture=no growth; stool culture=normal flora; x-ray upper GI with KUB=distended small bowel loops compatible with small bowel obstruction. The patient was discharged on 07-JUL-2007. The outcome was recovered. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Nausea, Neutrophil count increased, Pyrexia, Surgery, Vomiting
Clinical narrative: Information has been received from the FDA (VAERS # 284308) through the CDC concerning a 23-week-old male with a ventricular septal defect and a cardiac murmur and a history of bronchitis and pyloric stenosis (surgically repaired) who on 07-JUN-2007 was vaccinated with a second dose of Rotateq (Lot # "0578E"). Concomitant therapy that day included a second dose of DAPTACEL (Lot # C2650AA), a dose of COMVAX (Lot # Z0547), and a second dose of PREVNAR (Lot # B0674A). It was noted that on 30-JUN-2007, the patient complained of fever, nausea, and vomiting since the night before. The sudden onset of vomiting became projectile. The patient was noted to have bloody diarrhea and a temperature of 100.5. On 30-JUN-2007, 23 days post vaccination, the patient was diagnosed with intussusception and was hospitalized. An exploratory laparotomy and appendectomy were done on 02-JUL-2007. Lab values included: neutrophils=71.1; monocytes=2.9; potassium=2.0; sodium=147; urine culture=no growth; stool culture=normal flora; x-ray upper GI with KUB=distended small bowel loops compatible with small bowel obstruction. The patient was discharged on 07-JUL-2007. The outcome was recovered. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Vomiting projectile, X-ray with contrast upper gastrointestinal tract
Clinical narrative: Information has been received from the FDA (VAERS # 284308) through the CDC concerning a 23-week-old male with a ventricular septal defect and a cardiac murmur and a history of bronchitis and pyloric stenosis (surgically repaired) who on 07-JUN-2007 was vaccinated with a second dose of Rotateq (Lot # "0578E"). Concomitant therapy that day included a second dose of DAPTACEL (Lot # C2650AA), a dose of COMVAX (Lot # Z0547), and a second dose of PREVNAR (Lot # B0674A). It was noted that on 30-JUN-2007, the patient complained of fever, nausea, and vomiting since the night before. The sudden onset of vomiting became projectile. The patient was noted to have bloody diarrhea and a temperature of 100.5. On 30-JUN-2007, 23 days post vaccination, the patient was diagnosed with intussusception and was hospitalized. An exploratory laparotomy and appendectomy were done on 02-JUL-2007. Lab values included: neutrophils=71.1; monocytes=2.9; potassium=2.0; sodium=147; urine culture=no growth; stool culture=normal flora; x-ray upper GI with KUB=distended small bowel loops compatible with small bowel obstruction. The patient was discharged on 07-JUL-2007. The outcome was recovered. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PPV, RV5, DTAPHEPBIP, PPV, RV5
Symptoms: Blood glucose, Inappropriate schedule of drug administration, Intussusception, Lethargy, Pallor
Clinical narrative: Information has been received from the FDA (VAERS # 285725) through the CDC concerning a 6-month-old male with history of respiratory syncytial virus infection who on 03-JUL-2007 was vaccinated with a first dose of Rotateq (Lot # 657049/0503U). Concomitant therapy that day included a third dose of PEDIARIX (Lot # AC21B132BA) and a third dose of PNU-IMUNE (Lot # B58845H). There were no other concomitant medications. The patient was seen for lethargy and pallor. Glucose was at 110. He was sent to the emergency room for evaluation and admitted for intussusception. On 05-JUL-2007, 2 days post vaccination, the patient was diagnosed with intussusception and was hospitalized. Abdominal ultrasound revealed IT in the midtransverse colon. Abdominal ultrasound revealed nonobstructive bowel gas pattern with midepigastric soft tissue density. He complained of lethargy and became pale. There was no nausea, vomiting, diarrhea, or blood in stool. The IT was successfully reduced with air enema. The patient recovered. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PPV, RV5, DTAPHEPBIP, PPV, RV5
Symptoms: Ultrasound abdomen abnormal
Clinical narrative: Information has been received from the FDA (VAERS # 285725) through the CDC concerning a 6-month-old male with history of respiratory syncytial virus infection who on 03-JUL-2007 was vaccinated with a first dose of Rotateq (Lot # 657049/0503U). Concomitant therapy that day included a third dose of PEDIARIX (Lot # AC21B132BA) and a third dose of PNU-IMUNE (Lot # B58845H). There were no other concomitant medications. The patient was seen for lethargy and pallor. Glucose was at 110. He was sent to the emergency room for evaluation and admitted for intussusception. On 05-JUL-2007, 2 days post vaccination, the patient was diagnosed with intussusception and was hospitalized. Abdominal ultrasound revealed IT in the midtransverse colon. Abdominal ultrasound revealed nonobstructive bowel gas pattern with midepigastric soft tissue density. He complained of lethargy and became pale. There was no nausea, vomiting, diarrhea, or blood in stool. The IT was successfully reduced with air enema. The patient recovered. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PPV, RV5, DTAPHEPBIP, PPV, RV5
Symptoms: Abdominal X-ray, Blood glucose abnormal, Enema administration, Inappropriate schedule of drug administration, Intussusception
Clinical narrative: Information has been received from the FDA (VAERS # 285725) through the CDC concerning a 6-month-old male with history of respiratory syncytial virus infection who on 03-JUL-2007 was vaccinated with a first dose of Rotateq (Lot # 657049/0503U). Concomitant therapy that day included a third dose of PEDIARIX (Lot # AC21B132BA) and a third dose of PNU-IMUNE (Lot # B58845H). There were no other concomitant medications. The patient was seen for lethargy and pallor. Glucose was at 110. He was sent to the emergency room for evaluation and admitted for intussusception. On 05-JUL-2007, 2 days post vaccination, the patient was diagnosed with intussusception and was hospitalized. Abdominal ultrasound revealed IT in the midtransverse colon. Abdominal ultrasound revealed nonobstructive bowel gas pattern with midepigastric soft tissue density. He complained of lethargy and became pale. There was no nausea, vomiting, diarrhea, or blood in stool. The IT was successfully reduced with air enema. The patient recovered. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PPV, RV5, DTAPHEPBIP, PPV, RV5
Symptoms: Lethargy, Pallor, Ultrasound abdomen abnormal
Clinical narrative: Information has been received from the FDA (VAERS # 285725) through the CDC concerning a 6-month-old male with history of respiratory syncytial virus infection who on 03-JUL-2007 was vaccinated with a first dose of Rotateq (Lot # 657049/0503U). Concomitant therapy that day included a third dose of PEDIARIX (Lot # AC21B132BA) and a third dose of PNU-IMUNE (Lot # B58845H). There were no other concomitant medications. The patient was seen for lethargy and pallor. Glucose was at 110. He was sent to the emergency room for evaluation and admitted for intussusception. On 05-JUL-2007, 2 days post vaccination, the patient was diagnosed with intussusception and was hospitalized. Abdominal ultrasound revealed IT in the midtransverse colon. Abdominal ultrasound revealed nonobstructive bowel gas pattern with midepigastric soft tissue density. He complained of lethargy and became pale. There was no nausea, vomiting, diarrhea, or blood in stool. The IT was successfully reduced with air enema. The patient recovered. Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Intussusception, Surgery
Clinical narrative: Information has been received from the FDA (VAERS # 286500) through the CDC concerning a 19-week-old female with no history or preexisting conditions who on 01-JUN-2007 was vaccinated with a third dose of Rotateq (Lot # 656191/1365F). Concomitant therapy that day included a second dose of INFANRIX (Lot # AC148056BA), a second dose of ACTHIB (Lot # UF100AA), a second dose of IPOL (Lot # Z0548), and a second dose of PREVNAR (Lot # B08690C). There were no other concomitant medications. On 17-JAN-2007, 16 days post vaccination, the patient was diagnosed with intussusception and was hospitalized. The patient was operated on for intussusception in the hospital. The outcome was recovered. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5
Symptoms: Death, Developmental delay, Failure to thrive
Clinical narrative: Information has been received from a physician concerning a 2-month-old male with a history of genetic issues who in August 2007, was vaccinated with a dose of Rotateq. Concomitant vaccinations administered on the same day included a dose of PREVNAR and a dose of PEDIARIX. The physician reported that in August 2007, a couple of days after being vaccinated, the patient was admitted to the hospital with possible sepsis. On 25-AUG-2007, the patient died due to sepsis. The physician also considered sepsis to be immediately life-threatening. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5
Symptoms: Death, Sepsis
Clinical narrative: Information has been received from a physician concerning a 2-month-old male with a history of genetic issues who in August 2007, was vaccinated with a dose of Rotateq. Concomitant vaccinations administered on the same day included a dose of PREVNAR and a dose of PEDIARIX. The physician reported that in August 2007, a couple of days after being vaccinated, the patient was admitted to the hospital with possible sepsis. On 25-AUG-2007, the patient died due to sepsis. The physician also considered sepsis to be immediately life-threatening. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5
Symptoms: Death
Clinical narrative: Information has been received from a physician concerning a 2-month-old male with a history of genetic issues who in August 2007, was vaccinated with a dose of Rotateq. Concomitant vaccinations administered on the same day included a dose of PREVNAR and a dose of PEDIARIX. The physician reported that in August 2007, a couple of days after being vaccinated, the patient was admitted to the hospital with possible sepsis. On 25-AUG-2007, the patient died due to sepsis. The physician also considered sepsis to be immediately life-threatening. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Condition aggravated, Convulsion, Tremor
Clinical narrative: Information has been received from a physician concerning a 14 year old female with a history of seizure which the patient was put on medication for until the seizures were under control and had been off the medication for one year, since approximately August 2006, and who on 06-AUG-2007 was vaccinated with her first dose of the series with Gardasil, injection. On 16-AUG-2007 the patient experienced seizures and has had problems since, including tremors in her hand. It was reported that as of 27-AUG-2007, the patient was recovering. Unspecified medical attention was sought by the patient. Patient Quality Complaints (PQC) was not involved. Seizures and tremors in hand were considered disabling by the reporting physician. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Tremor
Clinical narrative: Information has been received from a physician concerning a 14 year old female with a history of seizure which the patient was put on medication for until the seizures were under control and had been off the medication for one year, since approximately August 2006, and who on 06-AUG-2007 was vaccinated with her first dose of the series with Gardasil, injection. On 16-AUG-2007 the patient experienced seizures and has had problems since, including tremors in her hand. It was reported that as of 27-AUG-2007, the patient was recovering. Unspecified medical attention was sought by the patient. Patient Quality Complaints (PQC) was not involved. Seizures and tremors in hand were considered disabling by the reporting physician. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature decreased, Body temperature increased, Discomfort, Fatigue, Influenza like illness
Clinical narrative: In about 11 hours after the vaccine I experienced physical discomfort and woke up from sleep (3 AM). By 9:30 AM I experienced flu like symptoms; body aches and general discomfort. By 2:00 PM my temperature began to rise and by 4:00 PM it reached 104 degrees Fahrenheit. I experienced violent shaking and called my doctor's office. They recommended certain medications: benedril and Ibuprofin. I took a couple of Tylenol and the temp dropped. I experienced continued discomfort; as if all the nerve endings on the surface of my body suddenly became very sensitive. I went to bed and slept fairly well. In the morning I felt quite tired but the shakes were gone and my temp. was down to 101. I missed my second day of work and rested. By evening I felt quite normal except that I was too tired to do any chores around my home. It took two more days for me to recover.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Tremor
Clinical narrative: In about 11 hours after the vaccine I experienced physical discomfort and woke up from sleep (3 AM). By 9:30 AM I experienced flu like symptoms; body aches and general discomfort. By 2:00 PM my temperature began to rise and by 4:00 PM it reached 104 degrees Fahrenheit. I experienced violent shaking and called my doctor's office. They recommended certain medications: benedril and Ibuprofin. I took a couple of Tylenol and the temp dropped. I experienced continued discomfort; as if all the nerve endings on the surface of my body suddenly became very sensitive. I went to bed and slept fairly well. In the morning I felt quite tired but the shakes were gone and my temp. was down to 101. I missed my second day of work and rested. By evening I felt quite normal except that I was too tired to do any chores around my home. It took two more days for me to recover.
Age: 17.0
Sex: F
Vaccine: HEP, HPV4
Symptoms: Hypoaesthesia, Myalgia, Paraesthesia, Pyrexia
Clinical narrative: Numbness, tingling of both hands, fingertips although worse on the right side where one of the vaccines was administered.  Also with fever to 99, myalgias beginning the day after.
Age: 0.2
Sex: F
Vaccine: HBHEPB, IPV, PNC, RV5
Symptoms: Haematochezia, Surgery, Vomiting
Clinical narrative: Information has been received from a physician concerning a 4 month old patient who on approximately 30-Jun-2007 and August 2007 was vaccinated with the first and second oral dose of Rotateq. Concomitant vaccinations at 2 months of age included "other vaccines." In August 2007, the patient developed vomiting and bloody stools. Medical attention was sought via office visit and ER visit. The patient was then admitted to the hospital, where surgery was performed. The physician stated that "the intestine was not cut during the surgery but relaxed." Subsequently, the patient recovered. There was no product quality complaint. The events were also considered to be an other important medical event (surgery). Additional information has been requested.  10/02/2007 Vax record received from reporter and info updated in database.  10/03/2007 Additional vax records received from CDC.  Database updated. 10/30/2007 MR received for DOS 8/17-21/2007 for DX: Intussusception.  Child presented to ER with irritability, bilious vomiting and  bloody stool. Temp =101'F.  PE (+) for decreased BS and palpable mass.  Diagnostic and therapeutic Barium Enema attempted with findings compatible with IS.  Unsuccessful attempt at reduction x 3.   Taken to OR for Exploratory Lap, Reduction of small bowel Intussusception with appendectomy. 10/19/2007 Records received for subsequent ER visit of 9/9/007 for vomiting and irritability S/P Intussusception with Surgical reduction on 8/17/2007.  Infant vomited x3 at home.  Crying was similar to when pt had IS. Irritability improved in ER. DX: Non-infectious gastroenteritis and colitis.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy, Pregnancy, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a physician concerning a 16 year old female with no pertinent medical history and drug reactions/allergies who on 15-JUN-2007 was vaccinated with Gardasil (lot# 657617/0384U) "single dose" in the left arm IM. There was no concomitant medication. The patient is currently pregnant. The date of the last menstrual period was in "early June 2007". Medical attention was sought. On an unspecified date the patient had a urine beta-human chorionic gonadotropin test performed and the results were positive. No symptoms have been reported. No further information was available. The estimated date of delivery is 07-MAR-2008. Follow-up information was received from the physician via telephone. The physician reported that the patient was going to be terminating her pregnancy. No further information was provided. Follow up information was received from a registered nurse via telephone. The patient was a white female who was seen in the office on 15-JUN-2007 at which time she was menstruating. The patient reported that she was not sexually active. The patient was vaccinated with Gardasil. On 10-AUG-2007 the patient returned to the office at which time she reported that she had become sexually active. A urine beta-human chorionic gonadotropin test sample was taken which was positive for pregnancy. The patient did not receive the vaccination. On 24-AUG-2007 a telephone call was placed to the patient and the physician's office was told that the pregnancy had been terminated electively. The patient was reported to be doing well. The nurse reported that the series of vaccinations will be continued when the patient returns to the office. Upon internal review elective abortion is considered to be an other important medical event. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old female, who on 08-AUG-2007 was vaccinated with a first dose of Gardasil (Lot# 658282/0929U). Concomitant therapy included Effexor. Subsequently, the patient experienced severe pain in her deltoid and she was unable to move her arm. The patient was seen in the emergency room but she was not admitted to the hospital. At the time of the report the patient was recovering. No product quality complaint was involved. The severe pain in her deltoid was considered to be disabling. Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/6/2007: 9/13/2007. Initial and follow-up information has been received from a registered nurse concerning a 12 year old female with no pertinent medical history and allergies to vancomycin and oxycontin, who on 08-Aug-2007 was vaccinated subcutaneously in the left deltoid with a first dose of GARDASIL (Lot # 658287/0929U). Concomitant therapy included EFFEXOR. Subsequently, the patient experienced severe pain in her deltoid and was unable to mover her arm for 2 weeks. The patient was seen in the emergency room but she was not admitted to the hospital and treatment was unknown. At the time of the report the patient was recovering. No product quality complaint was involved. The severe pain in her deltoid was considered to be disabling, in follow-up the registered nurse did not consider the event to be disabling as previously reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Laboratory test, Pain, Pain in extremity
Clinical narrative: Information has been received from a physician and a licensed practical nurse concerning a 13 year old female with no drug allergies and no medical history, who on 06-OCT-2006 was vaccinated intramuscularly into the right deltoid with a 0.5mL first dose of Gardasil. On 13-AUG-2007 the patient was vaccinated with a second dose of Gardasil. There was no concomitant medication. On 25-AUG-2007 the patient experienced pain that started in both arms, progressed to her legs, and then to her whole body. On 26-AUG-2007 the patient went to the emergency room. She was treated with over the counter analgesics and released. On 29-AUG-2007 she was seen at the office because the pain had not stopped. The patient had since been hospitalized, and the symptoms have continued to the present. It was also reported by the nurse that the patient received the injection in her left arm and that the left arm was more painful then the right arm. Laboratory diagnostics were performed but details were not available. At the time of the report the patient had not recovered. No product quality complaint was involved. The reporting physician considered pain that started in both arms, progressed to her legs and her whole body as an other important medical event. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Chest discomfort, Dyspnoea, Erythema, Eyelid oedema, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old male with reactive airway disease (since December 2002), history of premature birth and no allergies who in January 2003, was vaccinated IM with a first 0.5 ml dose of MMR II and on 25-AUG-2007 was vaccinated IM with second 0.5 ml dose of MMR II (Lot# 656527/0285U). Concomitant therapy included albuterol as needed. On 25-AUG-2007, soon after vaccination the patient experienced hives on face, wheezing, dyspnea, chest tightness, swollen eyelids and erythema on face, hands and back. It was reported that the patient was immediately treated with Benadryl IM, Decadron IM, epinephrine IM and nebulizer treatment. The patient was also given prednisone and albuterol as needed. On 25-AUG-2007, after soon vaccination the patient experienced hives on face, wheezing, dyspnea, chest tightness, swollen eyelids and erythema on face, hands and back. It was reported that the patient was immediately treated with Benadryl IM, Decadron IM, epinephrine IM and nebulizer treatment. The patient was also given prednisone and albuterol inhaler. Flovent was later added as needed. It was reported that the patient did not experience any adverse event with first dose of the vaccination. No diagnostic laboratory test was undertaken. At the time of report the patient had recovered. A product quality complaint was not involved. The patient's experiences were considered to be life threatening and an other important medical event by the reporter. A lot check has been initiated. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Urticaria, Wheezing
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old male with reactive airway disease (since December 2002), history of premature birth and no allergies who in January 2003, was vaccinated IM with a first 0.5 ml dose of MMR II and on 25-AUG-2007 was vaccinated IM with second 0.5 ml dose of MMR II (Lot# 656527/0285U). Concomitant therapy included albuterol as needed. On 25-AUG-2007, soon after vaccination the patient experienced hives on face, wheezing, dyspnea, chest tightness, swollen eyelids and erythema on face, hands and back. It was reported that the patient was immediately treated with Benadryl IM, Decadron IM, epinephrine IM and nebulizer treatment. The patient was also given prednisone and albuterol as needed. On 25-AUG-2007, after soon vaccination the patient experienced hives on face, wheezing, dyspnea, chest tightness, swollen eyelids and erythema on face, hands and back. It was reported that the patient was immediately treated with Benadryl IM, Decadron IM, epinephrine IM and nebulizer treatment. The patient was also given prednisone and albuterol inhaler. Flovent was later added as needed. It was reported that the patient did not experience any adverse event with first dose of the vaccination. No diagnostic laboratory test was undertaken. At the time of report the patient had recovered. A product quality complaint was not involved. The patient's experiences were considered to be life threatening and an other important medical event by the reporter. A lot check has been initiated. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Abscess, Culture wound negative
Clinical narrative: Pt was seen outpt with abscess for 2 days she was hospitalized 8/30/07. She was set home on Clindamycin. She received IV Clindamycin.  09/10/2007 MR received from hospital for DOS 8/30-9/1/2007 for DX of Abscess on the L arm at the injection site. Started on po abx at PCP's office however is now having increased discharge.  Also c/o joint pain. PE (+) for erythematous papular rash on the torso as well as injection site redness and tenderness. Improved on IV abx. Joint pain resolved.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Rotator cuff syndrome
Clinical narrative: Intermittent pain (R) shoulder after 3rd HPV injection for less than 14 days. Continues at present time.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Musculoskeletal pain, Oedema peripheral, Pain in extremity
Clinical narrative: (L) shoulder/arm pain and swelling, seen by MD for persistent pain and swelling 9 days post vaccination w/ limited ROM due to pain. 8/14/07 Pt saw MD - put on Prednisone and Iodine. 8/27/07 Spoke with pt and sxs gone.