chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Loss of consciousness, Pallor, Syncope
Clinical narrative: Fainted, pale, unconscious (4-5 minutes).
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Body temperature increased, Feeding disorder, Full blood count, Lethargy
Clinical narrative: Temperature elevation of 107 rectal reported by parent, decreased responsiveness, lethargy, decreased feeding.
Age: 20.0
Sex: M
Vaccine: HEPAB
Symptoms: Cellulitis, Injection site erythema, Injection site induration
Clinical narrative: Patient had a 6" red circle around the injection site that was firm to the touch. Patient was diagnosed with cellulitis and given Keflex with relief.
Age: 1.92
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Inappropriate schedule of drug administration, Medication error, No adverse effect, Wrong drug administered
Clinical narrative: Pediarix given when DTAP was to be given parents reports. No adverse events.
Age: 0.21
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Agitation, Body temperature increased, Pain
Clinical narrative: Temp 102-102 x 3 days, some site pain and fussiness x 2 days. No swelling or edema.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Body temperature increased
Clinical narrative: Temp 102 x 2 days, increased sleeping.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Body temperature increased, Injection site pain
Clinical narrative: Temp > 103 for 2 days, some site pain (no swelling or edema).
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Induration, Myalgia
Clinical narrative: In upper left arm with in 12 hrs of Hep B vaccination #1, pain started in muscle. Deep pain is very noticeable, also a "knot" in the muscle is present. Pain has remained consistent predictable since initial vaccination. Has not gotten worse or better.
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: Syncope
Clinical narrative: Fainted after receiving Hep B vaccine had fasted for blood test.
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Death
Clinical narrative: Initial report received on 28 February 2007 from another manufacturer, report number WAES0702USA03211. Verbatim from the report: "Information has been received concerning a 2 month old male who had hydronephrosis at birth who on 13-Feb-2007 was vaccinated with an oral first dose of Rotateq (lot #653661/0146P). Concomitant vaccination administered that day included an IM first dose in the left thigh of Daptacel (lot # C2630AA), an IM first dose in the right thigh of Comvax (lot #654904/0757F), an IM first dose in the right thigh of Prevnar (lot #B36258A) and a SC first dose in the left thigh of IPOL (lot #B0240). There were no other concomitant medications. On 14-Feb-2007 the patient was found dead on an unknown cause. It was reported that the patient was sleeping in bed with his mom. Additional information has been requested. The lot number for IPOL in the narrative portion of the received information was reported as B0240 (not a valid manufacturer number), and the lot number for IPOL in the product listings area of the information received was reported as Z0240 (not a valid manufacturer lot number).
Age: 8.0
Sex: F
Vaccine: PPV, PPV
Symptoms: C-reactive protein normal, Cellulitis, Erythema, Pain, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old female patient with complex congenital heart disease who on 21-FEB-2007 was vaccinated IM with a 0.5 mL first dose Pneumovax 23 (Lot# 65588/0883F). Concomitant therapy included amoxicillin. On approximately 23-FEB-2007, the patient developed progressive pain, redness and swelling at the injection site (time line unspecified). On 23-FEB-2007 the patient was seen in the office and due to the swelling and pain at the site, could not move the area. She was admitted to the hospital from 23-FEB-206 to 26-FEB-2007. The patient's white blood cell count was 14,700 and C-reactive protein was 1.0 at the time of admission to the hospital. The nurse reported that the patient was discharged from the hospital (date  unspecified) and she was not considered to be disabled by the events. She was considered recovered. The nurse requested a lot check. A lot check has been initiated. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: PPV, PPV
Symptoms: White blood cell count normal
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old female patient with complex congenital heart disease who on 21-FEB-2007 was vaccinated IM with a 0.5 mL first dose Pneumovax 23 (Lot# 65588/0883F). Concomitant therapy included amoxicillin. On approximately 23-FEB-2007, the patient developed progressive pain, redness and swelling at the injection site (time line unspecified). On 23-FEB-2007 the patient was seen in the office and due to the swelling and pain at the site, could not move the area. She was admitted to the hospital from 23-FEB-206 to 26-FEB-2007. The patient's white blood cell count was 14,700 and C-reactive protein was 1.0 at the time of admission to the hospital. The nurse reported that the patient was discharged from the hospital (date  unspecified) and she was not considered to be disabled by the events. She was considered recovered. The nurse requested a lot check. A lot check has been initiated. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: PPV, PPV
Symptoms: C-reactive protein decreased, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old female patient with complex congenital heart disease who on 21-FEB-2007 was vaccinated IM with a 0.5 mL first dose Pneumovax 23 (Lot# 65588/0883F). Concomitant therapy included amoxicillin. On approximately 23-FEB-2007, the patient developed progressive pain, redness and swelling at the injection site (time line unspecified). On 23-FEB-2007 the patient was seen in the office and due to the swelling and pain at the site, could not move the area. She was admitted to the hospital from 23-FEB-206 to 26-FEB-2007. The patient's white blood cell count was 14,700 and C-reactive protein was 1.0 at the time of admission to the hospital. The nurse reported that the patient was discharged from the hospital (date  unspecified) and she was not considered to be disabled by the events. She was considered recovered. The nurse requested a lot check. A lot check has been initiated. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: PPV, PPV
Symptoms: White blood cell count increased
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old female patient with complex congenital heart disease who on 21-FEB-2007 was vaccinated IM with a 0.5 mL first dose Pneumovax 23 (Lot# 65588/0883F). Concomitant therapy included amoxicillin. On approximately 23-FEB-2007, the patient developed progressive pain, redness and swelling at the injection site (time line unspecified). On 23-FEB-2007 the patient was seen in the office and due to the swelling and pain at the site, could not move the area. She was admitted to the hospital from 23-FEB-206 to 26-FEB-2007. The patient's white blood cell count was 14,700 and C-reactive protein was 1.0 at the time of admission to the hospital. The nurse reported that the patient was discharged from the hospital (date  unspecified) and she was not considered to be disabled by the events. She was considered recovered. The nurse requested a lot check. A lot check has been initiated. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Abnormal behaviour, Erythema, Induration, Skin warm
Clinical narrative: Erythematous induration of right upper arm, warm to touch, pt also c/o shoulder and acting funny on occasions. Pt sibling received the same vaccine and no reaction.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Convulsion, Crying, Eye rolling, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Approx 3 hours after immunization pt cried for 4 hours, mom gave pt Motrin, then pt got stiff eyes rolled back. Mom took pt to ER possible seizure, febrile 99 deg, pt brother has has of febrile seizures.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Swelling
Clinical narrative: Pt rcvd Dtap on 2/26/07 came in 72 hours later 3-1-07 with red raised area about 76 MM
Sex: U
Vaccine: HEPA, HIBV, PNC
Symptoms: Erythema, Swelling
Clinical narrative: Left arm, deltoid-swelling with redness.  Parent advised to give children's Motrin as needed and use an ice pack on deltoid.
Age: 41.0
Sex: M
Vaccine: YF
Symptoms: Incorrect dose administered, No adverse effect
Clinical narrative: 5 patients received a full dose vial (3.0 ml exconstituted dose) of yellow fever vaccine by mistake.  There is currently no symptomatic complaints.  This patient was identified as one of the possible recipients.
Age: 28.0
Sex: M
Vaccine: YF
Symptoms: Incorrect dose administered, No adverse effect
Clinical narrative: 5 patients received a full vial (3.0 ml reconstituted dose) of yellow fever vaccine by mistake.  There is currently no symptomatic complaints.  This patient was identified as one of the possible recipients.
Age: 44.0
Sex: M
Vaccine: YF
Symptoms: Incorrect dose administered, No adverse effect
Clinical narrative: 5 patients received a full vial (3.0 ml reconstituted dose) of yellow fever vaccine by mistake.  There is currently no symptomatic complaints. This patient was identified as one of the possible recipients.
Age: 35.0
Sex: M
Vaccine: YF
Symptoms: Incorrect dose administered, No adverse effect
Clinical narrative: 5 patients received a full vial (3.0 ml reconstituted dose) of yellow fever vaccine by mistake.  There is currently no symptomatic complaints. This patient was identified as one of the possible recipients.
Age: 44.0
Sex: M
Vaccine: YF
Symptoms: Incorrect dose administered, No adverse effect
Clinical narrative: 5 patients received a full vial (3.0 cc reconstituted dose) of yellow fever vaccine by mistake. There is currently no symptomatic complaints. This patient was identified as one of the possible recipients.
Age: 0.34
Sex: M
Vaccine: RV5, DTAP, HIBV, PNC, RV5
Symptoms: Intestinal resection, Intussusception
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a first and second dose of Rotateq on 28-NOV-2006 and 16-JAN-2007, respectively. On the evening of 22-FEB-2007 the patient experienced intussusception. No product quality complaint was involved. The route of administration was recorded as "injection" (further clarification is pending). Upon internal review, the patient's intussusception was considered to be an other important medical event. Additional information has been requested.  4/27/07 Received medical records from hospital which reveals patient experienced vomiting x 3 days prior to admit on 2/21-2/26/07.  Had been on antibiotics since 2/15 for ear infection.  Seen on day of admit at PCP office & sent for testing due to concerns of IS.  Exam also revealed right OM.  On 2/22 had currant jelly stool & was taken to OR on 2/22 where reduction & resection was done w/primary anastomosis.  Had gradual improvement to normal stools & feeding at d/c to home. FINAL DX: ileocolic intussusception involving terminal ileum & extending into left colon, not completely reducible.  Ileocecectomy w/end to end anastomosis.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Haematochezia, Irritability, Lethargy, Ultrasound abdomen, Urinary system X-ray
Clinical narrative: Information has been received from a physician concerning a 11 week male with gastrointestinal reflux disease and no known allergies who on 30-JAN-2007 was vaccinated with the first dose of Rotateq (Lot # 656102/1165F). Concomitant therapy included Prevnar, Comvax and PREVACID. On 15-FEB-2007 (several weeks after receiving first dose), the patient experienced bloody stool, and was irritable and lethargic. The patient had bloody stools for two days. The patient was taken to an emergency room but later was released. A KUB X-ray and abdominal ultrasound were performed (results were not provided). On 17-FEB-2007, the patient recovered from bloody stool, irritable and lethargic. Upon internal review, bloody stool was considered an other important medical event. There was no product quality complaint involved. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Crying, Culture stool negative, Haematochezia, Intestinal functional disorder, Mucous stools
Clinical narrative: Information has been received from a physician concerning a 2 month old male who on 30-JAN-2007 was vaccinated PO with a 2 cc dose of Rotateq. On 15-FEB-2007 the patient experienced bloody mucusy stool and went to the ER. He was tested for rotavirus antigens and was negative. The patient had stool cultures that were also negative. The patient was not admitted to the hospital. He went to a specialist and had a sonogram done which revealed a thickened bowel wall. After visiting the specialist the patient "was better". On 26-FEB-2007 the baby cried all day and the physician was worried about intussusception. It was also noted that the AE improved after stopping therapy. Upon internal review, bloody stool was considered an other important medical event. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Rotavirus test negative, Ultrasound abdomen abnormal, Ultrasound scan, Virus stool test negative
Clinical narrative: Information has been received from a physician concerning a 2 month old male who on 30-JAN-2007 was vaccinated PO with a 2 cc dose of Rotateq. On 15-FEB-2007 the patient experienced bloody mucusy stool and went to the ER. He was tested for rotavirus antigens and was negative. The patient had stool cultures that were also negative. The patient was not admitted to the hospital. He went to a specialist and had a sonogram done which revealed a thickened bowel wall. After visiting the specialist the patient "was better". On 26-FEB-2007 the baby cried all day and the physician was worried about intussusception. It was also noted that the AE improved after stopping therapy. Upon internal review, bloody stool was considered an other important medical event. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Balance disorder, Clumsiness, Coordination abnormal, Demyelination, Diplopia
Clinical narrative: Information has been received from a physician concerning a 15 year old female with no pertinent medical history and no drug reactions or allergies, who on 26-DEC-2006 was vaccinated with a 0.5 mL dose of Gardasil (Lot not reported). There was no concomitant medication. On 23-Jan-2007 the patient developed numbness of her face which eventually spread to her hands and legs. The patient was treated with prednisone and acyclovir. The numbness partially cleared but she then developed double vision, weakness of her right side, unbalance, decreased coordination and clumsiness of her hands. The patient sought unspecified medical attention. On 23-FEB-2007 the patient had a magnetic resonance imaging (MRI), which revealed demyelination and a spinal tap (results not available yet). The physician stated that the patient was starting to get better but was told the patient's parents stopped the Gardasil vaccine series. The dose of Gardasil vaccine was administered by the patient's primary care physician (PCP). The reporter considered the patient's numbness of her face, hands and legs, double vision, weakness of her right side, imbalance, decreased coordination, clumsiness of her hands and demyelination to be other important medical events. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hemiparesis, Hypoaesthesia, Hypoaesthesia facial, Lumbar puncture, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Information has been received from a physician concerning a 15 year old female with no pertinent medical history and no drug reactions or allergies, who on 26-DEC-2006 was vaccinated with a 0.5 mL dose of Gardasil (Lot not reported). There was no concomitant medication. On 23-Jan-2007 the patient developed numbness of her face which eventually spread to her hands and legs. The patient was treated with prednisone and acyclovir. The numbness partially cleared but she then developed double vision, weakness of her right side, unbalance, decreased coordination and clumsiness of her hands. The patient sought unspecified medical attention. On 23-FEB-2007 the patient had a magnetic resonance imaging (MRI), which revealed demyelination and a spinal tap (results not available yet). The physician stated that the patient was starting to get better but was told the patient's parents stopped the Gardasil vaccine series. The dose of Gardasil vaccine was administered by the patient's primary care physician (PCP). The reporter considered the patient's numbness of her face, hands and legs, double vision, weakness of her right side, imbalance, decreased coordination, clumsiness of her hands and demyelination to be other important medical events. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dysgraphia, Hypoaesthesia facial, Mobility decreased, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 15 year old female with no pertinent medical history and no drug reactions or allergies, who on 26-DEC-2006 was vaccinated with a 0.5 mL dose of Gardasil (Lot not reported). There was no concomitant medication. On 23-Jan-2007 the patient developed numbness of her face which eventually spread to her hands and legs. The patient was treated with prednisone and acyclovir. The numbness partially cleared but she then developed double vision, weakness of her right side, unbalance, decreased coordination and clumsiness of her hands. The patient sought unspecified medical attention. On 23-FEB-2007 the patient had a magnetic resonance imaging (MRI), which revealed demyelination and a spinal tap (results not available yet). The physician stated that the patient was starting to get better but was told the patient's parents stopped the Gardasil vaccine series. The dose of Gardasil vaccine was administered by the patient's primary care physician (PCP). The reporter considered the patient's numbness of her face, hands and legs, double vision, weakness of her right side, imbalance, decreased coordination, clumsiness of her hands and demyelination to be other important medical events. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Diplopia, Dysarthria, Dysphagia, Guillain-Barre syndrome
Clinical narrative: Onset 1/17/07 of weakness in legs ("rubbery feeling"), numbness in hands progressing to biceps - T-102 - neuro consult with diagnosis of Sensory Guillain Barre - in ICU on ventilator and receiving IVIG. In rehab 2-5 ---> 2-28-07: discharged with diplopia; right 7th cranial nerve palsy; dysarthria; dysphagia and decreased mobility. 03/19/07-records received from facility for DOS-01/18/07-02/01/07 and acute rehabilitation from 02/05-02/28/07 DC DX: Guillain Barre Syndrome DC DX: Neurological disorder with acute inflammatory demyelinating polyneuropathy "Guillain-Barre Syndrome". Right VII cranial nerve palsy. Diplopia. Dysphagia. Dysarthria. Steroid versus ICU psychosis, resolved. Depression/Anxiety. Pulmonary issues, status post pneumonia, History of COPD and pulmonary involvment of AIDP. Decreased mobility. Decreased ADL. Admission to acute inpatient rehabilitation. Presented with C/O numbness in hands and weakness in legs. Noted a slight cough running nose and watery eyes recently. Temp of 102. Admitted. Continued to have muscular weakness, ataxia and difficulty with ambulation.  Intubated and extubated.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Intensive care, Life support, Mobility decreased, Muscular weakness
Clinical narrative: Onset 1/17/07 of weakness in legs ("rubbery feeling"), numbness in hands progressing to biceps - T-102 - neuro consult with diagnosis of Sensory Guillain Barre - in ICU on ventilator and receiving IVIG. In rehab 2-5 ---> 2-28-07: discharged with diplopia; right 7th cranial nerve palsy; dysarthria; dysphagia and decreased mobility. 03/19/07-records received from facility for DOS-01/18/07-02/01/07 and acute rehabilitation from 02/05-02/28/07 DC DX: Guillain Barre Syndrome DC DX: Neurological disorder with acute inflammatory demyelinating polyneuropathy "Guillain-Barre Syndrome". Right VII cranial nerve palsy. Diplopia. Dysphagia. Dysarthria. Steroid versus ICU psychosis, resolved. Depression/Anxiety. Pulmonary issues, status post pneumonia, History of COPD and pulmonary involvment of AIDP. Decreased mobility. Decreased ADL. Admission to acute inpatient rehabilitation. Presented with C/O numbness in hands and weakness in legs. Noted a slight cough running nose and watery eyes recently. Temp of 102. Admitted. Continued to have muscular weakness, ataxia and difficulty with ambulation.  Intubated and extubated.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Neurological examination, VIIth nerve paralysis
Clinical narrative: Onset 1/17/07 of weakness in legs ("rubbery feeling"), numbness in hands progressing to biceps - T-102 - neuro consult with diagnosis of Sensory Guillain Barre - in ICU on ventilator and receiving IVIG. In rehab 2-5 ---> 2-28-07: discharged with diplopia; right 7th cranial nerve palsy; dysarthria; dysphagia and decreased mobility. 03/19/07-records received from facility for DOS-01/18/07-02/01/07 and acute rehabilitation from 02/05-02/28/07 DC DX: Guillain Barre Syndrome DC DX: Neurological disorder with acute inflammatory demyelinating polyneuropathy "Guillain-Barre Syndrome". Right VII cranial nerve palsy. Diplopia. Dysphagia. Dysarthria. Steroid versus ICU psychosis, resolved. Depression/Anxiety. Pulmonary issues, status post pneumonia, History of COPD and pulmonary involvment of AIDP. Decreased mobility. Decreased ADL. Admission to acute inpatient rehabilitation. Presented with C/O numbness in hands and weakness in legs. Noted a slight cough running nose and watery eyes recently. Temp of 102. Admitted. Continued to have muscular weakness, ataxia and difficulty with ambulation.  Intubated and extubated.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Full blood count, Metabolic function test, Vomiting
Clinical narrative: Excessive vomit followed with cough.
Age: 19.0
Sex: F
Vaccine: HPV4, MNQ, PPV
Symptoms: Erythema, Nausea, Pain, Pyrexia, Swelling
Clinical narrative: Right arm red, swollen, has fever, nausea, body aches, no rash or hives.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia, Vomiting
Clinical narrative: Mom reports pt developed a fever-102 deg F that evening and throughout the night.  Vomited formula bottle on 2/17/07 at 6:00 am. Continued with fever throughout the day. Tolerated smaller amounts of fluid that day. Fever ended at 6:00 pm 2/17/07.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling at injection site moderate, with erythema and warmth. Has continued x 5 days after injection.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site pain, Injection site swelling, Pain
Clinical narrative: Pain and swelling, lt deltoid. HA and body aches day after.
Age: 0.17
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Blood immunoglobulin G decreased, Culture stool, Diarrhoea haemorrhagic, Full blood count, Immunoglobulins
Clinical narrative: Bloody diarrhea 7-14 days after each Rotateq. No fever or other ill SX cultures negative. Immune W/U revealed low levels of IgG. Further eval is pending.
Age: 0.17
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Metabolic function test, Vaccine positive rechallenge
Clinical narrative: Bloody diarrhea 7-14 days after each Rotateq. No fever or other ill SX cultures negative. Immune W/U revealed low levels of IgG. Further eval is pending.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema multiforme
Clinical narrative: Developed erythema multiforme.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HEP, HIBV, IPV, PNC
Symptoms: Unevaluable event
Clinical narrative: Patient was given Pediarix 0.5ml, Plus IPV 0.5ml, Hepatitis B 0.5ml, Prevnar 0.5 ml.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Confusional state, Speech disorder
Clinical narrative: 03/02/07 mom calls and reports that about 9:30am) one hour after administration, pt became confused and had difficulty speaking. Had trouble putting words together. Today he seems more like himself, not confused. Activity normal. There was no loss of consciousness.
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: Rash on forehead, under lower eyelids, and on cheeks.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: intermittent elevated fever. Persistent x 8d.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Wed. 2/28 @ 5:30 rec'd Hep A#2 in thigh. Fri 3/2 @ 3:45pm noticed hives on bilat calves and left thigh and face.  Instructed mom to call Dr for further instructions.
Age: 5.0
Sex: U
Vaccine: DTAP
Symptoms: Erythema, Injection site erythema, Injection site swelling, Swelling
Clinical narrative: Initial report received from a health care provider on 27/Mar/2006. A five-year-old patient (gender not reported) had received an intramuscular, right arm injection of Daptacel, lot number C2405AA, on 22/Mar/2006. Two days later, the patient experienced "redness and swelling of the entire arm after vaccination". The patient had received four previous doses. At the time of this report, the patient had recovered from the event. The reporter in this case is the same as for cases 2006-00694, 2006-00695, 2006-00697, 2006-00698, 2006-00699, and 2006-00700.
Age: 5.0
Sex: U
Vaccine: DTAP
Symptoms: Erythema, Injection site erythema, Injection site swelling, Oedema peripheral
Clinical narrative: Initial report received from a health care provider on 27/Mar/2006. A five-year-old patient (gender not reported) had received an intramuscular, right arm injection of Daptacel, lot number C2405AA, on 22/Mar/2006. Two days later, the patient experienced "redness and swelling of the entire arm after vaccination". The patient had received four previous doses. At the time of this report, the patient had recovered from the event. The report in this case is the same as for cases 2006-00693, 2006-00695, 2006-00696, 2006-00697, 2006-00698, 2006-00699, and 2006-00700.
Age: 5.0
Sex: U
Vaccine: DTAP
Symptoms: Erythema, Injection site erythema, Injection site swelling, Oedema peripheral
Clinical narrative: Initial report received from a health care provider on 27/Mar/2006. A five-year-old patient (gender not reported) had received an intramuscular, right arm injection of Daptacel, lot number C2405AA, on 22/Mar/2006. Two days later, the patient experienced "redness and swelling of the entire arm after vaccination". The patient had received four previous doses. At the time of this report, the patient had recovered from the event. The reporter in this case is the same as for cases 2006-00694, 2006-00693, 2006-00696, 2006-00697, 2006-00698, 2006-00699, and 2006-00700.
Age: 5.0
Sex: U
Vaccine: DTAP
Symptoms: Erythema, Injection site erythema, Injection site swelling, Oedema peripheral
Clinical narrative: Initial report received from a health care provider on 27/Mar/2006. A five-year-old patient (gender not reported) had received an intramuscular, right arm injection of Daptacel, lot number number C2405AA, on 22/Mar/2006. Two days later, the patient experienced "redness and swelling of the entire arm after vaccination". The patient had received four previous doses. At the time of this report the patient had recovered from the event. The reporter in this case is the same as for 2006-00694, 2006-00695, 2006-00693, 2006-00697, 2006-00698, 2006-00699, and 2006-00700.
Age: 5.0
Sex: U
Vaccine: DTAP
Symptoms: Erythema, Injection site erythema, Injection site swelling, Oedema peripheral
Clinical narrative: Initial report received from a health care provider on 27/Mar/2006. A five-year-old patient (gender not reported) had received an intramuscular, right arm injection of Daptacel, lot number number C2405AA, on 22/Mar/2006. Two days later, the patient experienced "redness and swelling of the entire arm after vaccination". The patient had received four previous doses. At the time of this report the patient had recovered from the event. The reporter in this case is the same as for 2006-00694, 2006-00695, 2006-00693, 2006-00696, 2006-00698, 2006-00699, and 2006-00700.
Age: 5.0
Sex: U
Vaccine: DTAP
Symptoms: Erythema, Injection site erythema, Injection site swelling, Oedema peripheral
Clinical narrative: Initial report received from a health care provider on 27/Mar/2006. A five-year-old patient (gender not reported had received an intramuscular, right arm injection of Daptacel, lot number number C2405AA, on 22/Mar/2006. Two days later, the patient experienced "redness and swelling of the entire arm after vaccination". The patient had received four previous doses. At the time of this report the patient had recovered from the event. The reporter in this case is the same as for 2006-00694, 2006-00695, 2006-00696, 2006-00697, 2006-00693, 2006-00699, and 2006-00700.
Age: 5.0
Sex: U
Vaccine: DTAP
Symptoms: Erythema, Injection site erythema, Injection site swelling, Oedema peripheral
Clinical narrative: Initial report received from a health care provider on 27/Mar/2006. A five-year-old patient (gender not reported had received an intramuscular, right arm injection of Daptacel, lot number number C2405AA, on 22/Mar/2006. Two days later, the patient experienced "redness and swelling of the entire arm after vaccination". The patient had received four previous doses. At the time of this report the patient had recovered from the event. The reporter in this case is the same as for 2006-00694, 2006-00695, 2006-00696, 2006-00697, 2006-00698, 2006-00693, and 2006-00700.
Age: 5.0
Sex: U
Vaccine: DTAP
Symptoms: Erythema, Injection site erythema, Injection site swelling, Oedema peripheral
Clinical narrative: Initial report received from a health care provider on 27/Mar/2006. A five-year-old patient (gender not reported had received an intramuscular, right arm injection of Daptacel, lot number number C2405AA, on 22/Mar/2006. Two days later, the patient experienced "redness and swelling of the entire arm after vaccination". The patient had received four previous doses. At the time of this report the patient had recovered from the event. The reporter in this case is the same as for 2006-00694, 2006-00695, 2006-00696, 2006-00697, 2006-00698, 2006-00699, and 2006-00693.
Age: 0.18
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Rash
Clinical narrative: A two-month-old male patient received initial doses of Daptacel, lot number C2406AA, administered intra-muscularly in the right thigh, IPOL, lot number Y1050-2, administered subcutaneously in the left thigh, Comvax (manufacturer reported), lot number 00012F, administered intra-muscularly in the left thigh and Prevnar (manufacturer reported), lot number B086518, administered intra-muscularly in the right thigh on 20/Jun/2006. Four days later, the patient developed a rash on both legs below the knee. The patient recovered from this event. Follow-up information received on 28/Aug/2006 from a health care provider. The patient had no relevant diagnostic testings. He was not taking other medications. Additional medically relevant information was not provided.
Age: 0.34
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Injection site nodule, Livedo reticularis, Oedema peripheral, Skin lesion
Clinical narrative: Initial report received on 10/Aug/2006 from a physician. A four-month old male patient, with no past medical history, had received a second dose, right thigh injection of Daptacel, lot number C2432AA; a second dose, right thigh injection of IPOL, lot number not reported; a second dose, left thigh injection of Prevnar, manufacturer reported, lot number B086828; on 07/Aug/2006. The patient had also received a prior dose of Recombivax HB, manufacturer reported, lot number not reported, on 07/Jul/2006. Per the reporter, the "patient received Daptacel and IPOL in the right thigh and approximately 48 hours later it was reported to the doctor that the leg appears mottled and is swollen." Upon exam by the physician,"it appears as there was older bruising and some burst capillaries at the site." It was additionally reported by a physician, on 11/Aug/2006, that the patient had presented with marked, inconsolable fussiness, a nodule at the Daptacel injection site and numerous small purple lesions from pin to pea size on the anterior and posterior injected limb. The patient subsequently developed a similar lesion on the contralateral limb raising concern for a systemic or vasculitic process. However, the patient was afebrile and did not appear systemically ill. He was referred to an infectious disease specialist for evaluation. At the time of this report the patient had not recovered.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Adverse event, Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Initial report received on 11/Aug/2006 from a health care professional. A five-year-old female patient with no known allergies and no illnesses had received a fifth intramuscular dose of Daptacel, lot number C2243AA, in the left thigh on 09/Aug/2006. Concomitant vaccines received that day were a fourth dose of IPOL, lot number X1240, in the right thigh, and a second subcutaneous dose of MMR II (manufacturer reported), lot number 0634P, in the right thigh. The patient experienced a two and a half raised reddened area with itchiness 48 hours post vaccination. The adverse events occurred in the left thigh where the Daptacel vaccine was administered. The patient was evaluated by a physician that day, and prescribed benadryl and cool packs to the area. The recovery status of the patient was reported as not recovered. Follow-up information received on 01/Sep/2006 from a health care professional. Per the reporter, the patient's parent had reported itching and rash at the "injection site only". It was treated with Benadryl and resolved in three days. The patient had experienced no further symptoms and recovered from the event.
Age: 50.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Local reaction, Medication error
Clinical narrative: Initial report received on 11/Sep/2006 from a health care provider. A cluster of 10 adult patients were inadvertently administered an injection of Daptacel, lot number C2630AA, (instead of Adacel), on 08/Sep/2006. (Daptacel is not recommended for use in adult age groups). Twenty-four hours later, all ten patients complained of muscle aches and one patient complained of a local reaction. The symptoms of all of the patients experiencing muscles aches had resolved except one. At the time of this report, not all of the patients had recovered. Follow-up information received on 10 November 2006 from a health care provider. Individual information was provided for each patient. This patient was a 50-year-old female who experienced a local reaction that was red, sore, and indurated for approximately one week and was limited to the left deltoid Daptacel injection site. The patient recovered from the event. The reporter in this same as the reporter in cases 2006-03043, 2006-03044, 2006-03045, 2006-03046, 2006-03047, 2006-03048, 2006-03049, and 2006-03051.
Age: 50.0
Sex: F
Vaccine: DTAP
Symptoms: Myalgia, Wrong drug administered
Clinical narrative: Initial report received on 11/Sep/2006 from a health care provider. A cluster of 10 adult patients were inadvertently administered an injection of Daptacel, lot number C2630AA, (instead of Adacel), on 08/Sep/2006. (Daptacel is not recommended for use in adult age groups). Twenty-four hours later, all ten patients complained of muscle aches and one patient complained of a local reaction. The symptoms of all of the patients experiencing muscles aches had resolved except one. At the time of this report, not all of the patients had recovered. Follow-up information received on 10 November 2006 from a health care provider. Individual information was provided for each patient. This patient was a 50-year-old female who experienced a local reaction that was red, sore, and indurated for approximately one week and was limited to the left deltoid Daptacel injection site. The patient recovered from the event. The reporter in this same as the reporter in cases 2006-03043, 2006-03044, 2006-03045, 2006-03046, 2006-03047, 2006-03048, 2006-03049, and 2006-03051.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Initial report received on 22/Sep/2006 from a healthcare professional. A five-year-old male patient with no current illnesses had received a fifth intra-muscular dose of Daptacel, lot number C2407AA, in the left thigh, an intra-muscular dose of IPOL, lot number Y0638-2, in the left thigh, and a concomitant subcutaneous dose of MMR II (manufacturer reported), lot number 0215F, in the right thigh on 13/Sep/2006. The next day, the patient experienced injection site redness and warmth on the left thigh. The reaction was reported as being five inches in diameter. A 25g one inch needle was used to administer the vaccines. The patient had no other symptoms. The patient was seen by the physician two days later for medical evaluation but the treatments received were not reported. At the time of this report, the patient had recovered from these events. Follow-up information received on 16 November 2006 from a health care provider. No diagnostic testing was performed.
Age: 0.18
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Pallor, Screaming
Clinical narrative: Initial report received on 18 October 2006 from a health care professional. A two-month-old female patient, with a past medical history of torticollis, had received a first dose, left thigh injection of ActHIB, lot number C2650AA; a first dose, left thigh injection of IPOL, lot number Z2001-2; and a first dose, right thigh injection of Prevnar, manufacturer reported, lot number B08646E; on 17 October 2006 at 3:30 pm. Immediately post-vaccination, the infant was crying and screaming, then quit crying, put her head back and turned pale. Her lips were not blue. The patient was still without any abnormal movement. The length of the episode was not reported. At 11:00 pm, the parents took the patient to an emergency room for evaluation. No description of events that precipitated this visit were provided. Blood and urine testings were performed, but no results were provided. Per the reporter, "no spinal tap done." The patient was re-examined by the pediatrician on 18 October 2006 and was noted to be well. On the same day, the patient received a first dose, oral administration of Rotateq, manufacturer reported, lot number 0849F. At the time of this report, the patient had recovered.
Age: 47.0
Sex: F
Vaccine: DTAP
Symptoms: Medication error, Myalgia, Wrong drug administered
Clinical narrative: Initial report received on 10 November 2006 from the patient who is also a health care professional. A 47-year-old female patient had inadvertently received a left deltoid, intramuscular injection of Daptacel, (product not recommended for use in this age group). lot number C2630AA, on 01 September 2006. This product was administered instead Adacel. The following day, the patient experienced muscle soreness. No testing or examination by a physician was required. The patient took nonsteroidal anti-inflammatory medications as needed. The patient recovered from the event within 96 hours.  The reporter in this case is the same as the reporter in cases 2006-02409, 2006-03044, 2006-03045, 2006-03046, 2006-03047, 2006-03048, 2006-03049, 2006-03050, and 2006-03051.
Age: 38.0
Sex: F
Vaccine: DTAP
Symptoms: Medication error, Myalgia, Wrong drug administered
Clinical narrative: Initial report received on 10 December 2006 a health care professional. A 38-year-old female patient had inadvertently received a left deltoid, intramuscular injection of Daptacel, (product not recommended for use in this age group), lot number C2630AA, on 18 August 2006. This product was administered instead of Adacel. The following day, the patient experienced muscle soreness. No testing or examination by a physician was required. The patient took nonsteroidal anti-inflammatory medications as needed. The patient recovered from the event within 96 hours. The reporter in this case is the same as the reporter in cases 2006-02409, 2006-03043, 2006-03045, 2006-03046, 2006-03047, 2006-03048, 2006-03049, 2006-03050, and 2006-03051.
Age: 35.0
Sex: F
Vaccine: DTAP
Symptoms: Medication error, Myalgia, Wrong drug administered
Clinical narrative: Initial report received on 10 November 2006 a health care professional. A 35-year-old female patient had inadvertently received a left deltoid, intramuscularly injection if Daptacel, (product not recommended for use in this age group). lot number C2630AA, on 18 August 2006. This product was administered instead of Adacel. The following day, the patient experienced muscle soreness. No testing or examination by a physician was required. The patient took nonsteroidal anti-inflammatory medications as needed. The patient recovered from the event within 96 hours. The reporter in this case in the same as the reporter in cases 2006-02409, 2006-03043, 2006-03044, 2006-03046, 2006-03047, 2006-03048, 2006-03049, 2006-03050, and 2006-03051.
Age: 45.0
Sex: F
Vaccine: DTAP
Symptoms: Medication error, Myalgia, Wrong drug administered
Clinical narrative: Initial report received on 10 November 2006 a health care professional. A 45-year-old female patient had inadvertently received a left deltoid, intramuscularly injection if Daptacel, (product not recommended for use in this age group). lot number C2630AA, on 18 August 2006. This product was administered instead of Adacel. The following day, the patient experienced muscle soreness. No testing or examination by a physician was required. The patient took nonsteroidal anti-inflammatory medications as needed. The patient recovered from the event within 96 hours. The reporter in this case in the same as the reporter in cases 2006-02409, 2006-03043, 2006-03044, 2006-03045, 2006-03047, 2006-03048, 2006-03049, 2006-03050, and 2006-03051.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Wrong drug administered
Clinical narrative: A 27-year-old female patient had inadvertently received a left deltoid, intramuscular injection of Daptacel, (product not recommended for use in this age group), lot number C2630AA, on 01 September 2006. This product was administered instead of Adacel.  The following day, the patient experienced muscle soreness. No testing or examination by a physician was required. The patient took nonsteroidal anti-inflammatory medications as needed. The patient recovered from the event within 96 hours.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Muscle spasms, Myalgia, Wrong drug administered
Clinical narrative: A 45-year-old female patient had inadvertently received a left deltoid, intramuscular injection of Daptacel, (product not recommended for use in this group), lot number C2630AA, on 08 September 2006. This product was administered instead of Adacel.  The following day, the patient experienced muscle spasms.  No testing or examination by a physician was required. the patient took nonsteroidal anti-inflammatory medications as needed.  The patient recovered from the event within 96 hours.  The reporter in this case is the same as the reporter in cases 2006-02409, 2006-03043, 2006-03044, 2006-03045, 2006-03046, 2006-03047, 2006-03049, 2006-03050, and 2006-03051.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Wrong drug administered
Clinical narrative: A 50-year-old female patient had inadvertently received a left deltoid, intramuscular injection of Daptacel, (product not recommended for use in this age group), lot number C26300AA, on 18 August 2006. This product was administered instead of Adacel. The following day, the patient experienced muscle soreness. No testing or examination by a physician was required. The patient took nonsteroidal anti-inflammatory medications as needed. The patient recovered from the event within 96 hours. The reporter in this case is the same as the reporter in cases 2006-02409, 2006-03043, 2006-03044, 2006-03045, 2006-03046, 2006-03047, 2006-03048, 2006-03050, and 2006-03051.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Wrong drug administered
Clinical narrative: A 45-year-old female patient had inadvertently received a left deltoid, intramuscular injection of Daptacel, (product not recommended for use in this age group), lot number C2630AA, on 01 September 2006. This product was administered instead of Adacel. The following day, the patient experienced muscle soreness. No testing or examination by a physician was required. The patient took non steroidal anti-inflammatory medications as needed. The patient recovered from the event with in 96 hours.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Myalgia, Wrong drug administered
Clinical narrative: Initial report received on 10 November 206 a health care professional. A 45-year-old female patient had inadvertently received a left deltoid, intramuscular injection of Daptacel, (product not recommended for use in this age group), lot number C2630AA, on 01 September 2006. This product was administered instead of Adacel. The following day, the patient experienced muscle soreness, and she had a local reaction of redness and it was indurated. No testing or examination by a physician was required. The patient took nonsteroidal anti-inflammatory medications as noted. The patient recovered from the injection site redness and induration six to eight hours after onset of the adverse event. The patient recovered from the muscle soreness within 96 hours after onset of the adverse event.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Otitis media, Sinusitis
Clinical narrative: Initial report received from a physician in the USA on 04 January 2007. A 2 1/2 year old, male patient (with a history of mild respiratory distress) received 4 doses of Daptacel up to date. He had recurrent sinusitis and otitis media. An ENT physician drew a tetanus antitoxoid IGG titer which was less than 0.1 IU/mL (protective level according to the laboratory is 0.4 IU/mL). Additionally, the diphtheria level was 1.67 IU/mL, which the doctor stated was consistent with a protective level.  The patient's recovery status was not reported.
Age: 0.18
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Amino acid level, Aphasia, Blood culture, CSF test normal, Convulsion
Clinical narrative: Baby became very pale, white lips 3 brief seizures (2) hospitalizations - for decrease appetite, increase irritability poor eye contact, loss of verbal coo / 8 only - on day 4 after event - resolving symptoms. Seen in ER awake, alert, PE WNL. labs negative. CSF negative. Blood culture leukocytosis. MRI normal. EEG normal.  5/25/07-no DC summary only progress note available for short stay. received progress note Impression. new onset seizure times three without recurrence. question abnormal behavior, not seen here.
Age: 0.18
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Culture urine, Decreased appetite, Decreased eye contact, Disturbance in attention, Electroencephalogram normal
Clinical narrative: Baby became very pale, white lips 3 brief seizures (2) hospitalizations - for decrease appetite, increase irritability poor eye contact, loss of verbal coo / 8 only - on day 4 after event - resolving symptoms. Seen in ER awake, alert, PE WNL. labs negative. CSF negative. Blood culture leukocytosis. MRI normal. EEG normal.  5/25/07-no DC summary only progress note available for short stay. received progress note Impression. new onset seizure times three without recurrence. question abnormal behavior, not seen here.