chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Anorexia, Insomnia, Liver function test abnormal, Malaise, Pallor
Clinical narrative: From initial information received on 9/22/03, first dose, second dose, regarding separate adverse events occurring in the US for the same patient, it was reported that a 2 month old male patient received his first doses of ACTHIB, IPOL, TRIPEDIA, PREVNAR and RECOMBIVAX-HB on 6/16/03. The lot numbers and route/site were all not reported. On 6/18/03, two days post vaccination, the patient did not feel well, had a gurgling stomach, did not sleep, eat or drink, looked grey/white, was vomiting while also having abnormal urine and liver enzymes. Reportedly, on 8/19/03, the patient also received his second doses of ACTHIB, IPOL, TRIPEDIA, PREVNAR and RECOMBIVAX-HB. The lot numbers and route/site were all not reported. The same day, the patient developed a fever, experienced fussiness, screaming/crying, vomiting and looked grey/white. These events were reported as medically important (OMIC). The patient has since recovered from all the events reported.  Follow up on 10/20/2003: "From additional information received on 10/07/2003, from Merck (WAES0309USA03338), it was reported that "it has been determined that WAES # 0309USA03338 is a duplicate report of WAES # 0309USA02269.  Therefore, WAES # 0309USA03338 is being deleted from our files and the reported consolidated into WAES # 0309USA02269.  No further information is available."  Follow up on 10/20/2003: "From additional information received on 10/13/2003 (VAERS form from Merck), the dates and results of diagnostic and laboratory tests were provided.  Please refer to the Lab Data section for information (section 12 of the VAERS form)."
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Urine analysis abnormal, Vomiting
Clinical narrative: From initial information received on 9/22/03, first dose, second dose, regarding separate adverse events occurring in the US for the same patient, it was reported that a 2 month old male patient received his first doses of ACTHIB, IPOL, TRIPEDIA, PREVNAR and RECOMBIVAX-HB on 6/16/03. The lot numbers and route/site were all not reported. On 6/18/03, two days post vaccination, the patient did not feel well, had a gurgling stomach, did not sleep, eat or drink, looked grey/white, was vomiting while also having abnormal urine and liver enzymes. Reportedly, on 8/19/03, the patient also received his second doses of ACTHIB, IPOL, TRIPEDIA, PREVNAR and RECOMBIVAX-HB. The lot numbers and route/site were all not reported. The same day, the patient developed a fever, experienced fussiness, screaming/crying, vomiting and looked grey/white. These events were reported as medically important (OMIC). The patient has since recovered from all the events reported.  Follow up on 10/20/2003: "From additional information received on 10/07/2003, from Merck (WAES0309USA03338), it was reported that "it has been determined that WAES # 0309USA03338 is a duplicate report of WAES # 0309USA02269.  Therefore, WAES # 0309USA03338 is being deleted from our files and the reported consolidated into WAES # 0309USA02269.  No further information is available."  Follow up on 10/20/2003: "From additional information received on 10/13/2003 (VAERS form from Merck), the dates and results of diagnostic and laboratory tests were provided.  Please refer to the Lab Data section for information (section 12 of the VAERS form)."
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Crying, Insomnia, Irritability, Liver function test abnormal, Malaise
Clinical narrative: From initial information received on 9/22/03, first dose, second dose, regarding separate adverse events occurring in the US for the same patient, it was reported that a 2 month old male patient received his first doses of ACTHIB, IPOL, TRIPEDIA, PREVNAR and RECOMBIVAX-HB on 6/16/03. The lot numbers and route/site were all not reported. On 6/18/03, two days post vaccination, the patient did not feel well, had a gurgling stomach, did not sleep, eat or drink, looked grey/white, was vomiting while also having abnormal urine and liver enzymes. Reportedly, on 8/19/03, the patient also received his second doses of ACTHIB, IPOL, TRIPEDIA, PREVNAR and RECOMBIVAX-HB. The lot numbers and route/site were all not reported. The same day, the patient developed a fever, experienced fussiness, screaming/crying, vomiting and looked grey/white. These events were reported as medically important (OMIC). The patient has since recovered from all the events reported.  Follow up on 10/20/2003: "From additional information received on 10/07/2003, from Merck (WAES0309USA03338), it was reported that "it has been determined that WAES # 0309USA03338 is a duplicate report of WAES # 0309USA02269.  Therefore, WAES # 0309USA03338 is being deleted from our files and the reported consolidated into WAES # 0309USA02269.  No further information is available."  Follow up on 10/20/2003: "From additional information received on 10/13/2003 (VAERS form from Merck), the dates and results of diagnostic and laboratory tests were provided.  Please refer to the Lab Data section for information (section 12 of the VAERS form)."
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Oral intake reduced, Pallor, Pyrexia, Screaming, Stomach discomfort
Clinical narrative: From initial information received on 9/22/03, first dose, second dose, regarding separate adverse events occurring in the US for the same patient, it was reported that a 2 month old male patient received his first doses of ACTHIB, IPOL, TRIPEDIA, PREVNAR and RECOMBIVAX-HB on 6/16/03. The lot numbers and route/site were all not reported. On 6/18/03, two days post vaccination, the patient did not feel well, had a gurgling stomach, did not sleep, eat or drink, looked grey/white, was vomiting while also having abnormal urine and liver enzymes. Reportedly, on 8/19/03, the patient also received his second doses of ACTHIB, IPOL, TRIPEDIA, PREVNAR and RECOMBIVAX-HB. The lot numbers and route/site were all not reported. The same day, the patient developed a fever, experienced fussiness, screaming/crying, vomiting and looked grey/white. These events were reported as medically important (OMIC). The patient has since recovered from all the events reported.  Follow up on 10/20/2003: "From additional information received on 10/07/2003, from Merck (WAES0309USA03338), it was reported that "it has been determined that WAES # 0309USA03338 is a duplicate report of WAES # 0309USA02269.  Therefore, WAES # 0309USA03338 is being deleted from our files and the reported consolidated into WAES # 0309USA02269.  No further information is available."  Follow up on 10/20/2003: "From additional information received on 10/13/2003 (VAERS form from Merck), the dates and results of diagnostic and laboratory tests were provided.  Please refer to the Lab Data section for information (section 12 of the VAERS form)."
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Crying, Hepatic enzyme abnormal, Hepatic function abnormal, Irritability, Liver disorder
Clinical narrative: From initial information received on 9/22/03, first dose, second dose, regarding separate adverse events occurring in the US for the same patient, it was reported that a 2 month old male patient received his first doses of ACTHIB, IPOL, TRIPEDIA, PREVNAR and RECOMBIVAX-HB on 6/16/03. The lot numbers and route/site were all not reported. On 6/18/03, two days post vaccination, the patient did not feel well, had a gurgling stomach, did not sleep, eat or drink, looked grey/white, was vomiting while also having abnormal urine and liver enzymes. Reportedly, on 8/19/03, the patient also received his second doses of ACTHIB, IPOL, TRIPEDIA, PREVNAR and RECOMBIVAX-HB. The lot numbers and route/site were all not reported. The same day, the patient developed a fever, experienced fussiness, screaming/crying, vomiting and looked grey/white. These events were reported as medically important (OMIC). The patient has since recovered from all the events reported.  Follow up on 10/20/2003: "From additional information received on 10/07/2003, from Merck (WAES0309USA03338), it was reported that "it has been determined that WAES # 0309USA03338 is a duplicate report of WAES # 0309USA02269.  Therefore, WAES # 0309USA03338 is being deleted from our files and the reported consolidated into WAES # 0309USA02269.  No further information is available."  Follow up on 10/20/2003: "From additional information received on 10/13/2003 (VAERS form from Merck), the dates and results of diagnostic and laboratory tests were provided.  Please refer to the Lab Data section for information (section 12 of the VAERS form)."
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Malaise, Oral intake reduced, Pallor, Pyrexia, Renal impairment
Clinical narrative: From initial information received on 9/22/03, first dose, second dose, regarding separate adverse events occurring in the US for the same patient, it was reported that a 2 month old male patient received his first doses of ACTHIB, IPOL, TRIPEDIA, PREVNAR and RECOMBIVAX-HB on 6/16/03. The lot numbers and route/site were all not reported. On 6/18/03, two days post vaccination, the patient did not feel well, had a gurgling stomach, did not sleep, eat or drink, looked grey/white, was vomiting while also having abnormal urine and liver enzymes. Reportedly, on 8/19/03, the patient also received his second doses of ACTHIB, IPOL, TRIPEDIA, PREVNAR and RECOMBIVAX-HB. The lot numbers and route/site were all not reported. The same day, the patient developed a fever, experienced fussiness, screaming/crying, vomiting and looked grey/white. These events were reported as medically important (OMIC). The patient has since recovered from all the events reported.  Follow up on 10/20/2003: "From additional information received on 10/07/2003, from Merck (WAES0309USA03338), it was reported that "it has been determined that WAES # 0309USA03338 is a duplicate report of WAES # 0309USA02269.  Therefore, WAES # 0309USA03338 is being deleted from our files and the reported consolidated into WAES # 0309USA02269.  No further information is available."  Follow up on 10/20/2003: "From additional information received on 10/13/2003 (VAERS form from Merck), the dates and results of diagnostic and laboratory tests were provided.  Please refer to the Lab Data section for information (section 12 of the VAERS form)."
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Sleep disorder, Urine analysis abnormal, Vomiting
Clinical narrative: From initial information received on 9/22/03, first dose, second dose, regarding separate adverse events occurring in the US for the same patient, it was reported that a 2 month old male patient received his first doses of ACTHIB, IPOL, TRIPEDIA, PREVNAR and RECOMBIVAX-HB on 6/16/03. The lot numbers and route/site were all not reported. On 6/18/03, two days post vaccination, the patient did not feel well, had a gurgling stomach, did not sleep, eat or drink, looked grey/white, was vomiting while also having abnormal urine and liver enzymes. Reportedly, on 8/19/03, the patient also received his second doses of ACTHIB, IPOL, TRIPEDIA, PREVNAR and RECOMBIVAX-HB. The lot numbers and route/site were all not reported. The same day, the patient developed a fever, experienced fussiness, screaming/crying, vomiting and looked grey/white. These events were reported as medically important (OMIC). The patient has since recovered from all the events reported.  Follow up on 10/20/2003: "From additional information received on 10/07/2003, from Merck (WAES0309USA03338), it was reported that "it has been determined that WAES # 0309USA03338 is a duplicate report of WAES # 0309USA02269.  Therefore, WAES # 0309USA03338 is being deleted from our files and the reported consolidated into WAES # 0309USA02269.  No further information is available."  Follow up on 10/20/2003: "From additional information received on 10/13/2003 (VAERS form from Merck), the dates and results of diagnostic and laboratory tests were provided.  Please refer to the Lab Data section for information (section 12 of the VAERS form)."
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Adenocarcinoma, Weight decreased
Clinical narrative: This subject is a 71 year old male who was admitted to the hospital for an exploratory laparotomy and was found to have metastatic adenocarcinoma while enrolled in RSV 11 study. The subject received RSV vaccine or Placebo and Influenza Vaccine on 10/14/02. The subject developed stomach pain and weight loss and 185 days post-immunization on 4/17/03 was admitted to the hospital for an exploratory laparotomy and liver biopsy and was found to have metastatic adenocarcinoma consistent with pancreatic origin. Oncologist recommended palliative chemotherapy. Investigator is awaiting more records and will send when received. Patient was discharged on 4/22/03. Outcome is ongoing. Diagnosis: Metastatic Adenocarcinoma to the liver from the pancreas. The investigator assessed the event as unrelated to the study product. Follow up information received on 5/23/03. MediPort insertion was done on 5/8/03. On the 5/6/03 chemotherapy was initiated with Gemzar, 1000mg IV on day one and day eight, also Xeloda 650mg BID for 14 days. This cycle it to be repeated every 21 days as long as blood counts tolerate. Subject was also started on Pancrease 2 to 3 tablets before meals for indigestion and Duragesic 50mcg every 72 hours for pain relief. Additional information received on 9/24/03. The subject died 344 days after receiving RSV vaccine or Placebo and Influenza vaccine. Death: 9/23/03. The death was reported by the investigator as unrelated to the study vaccine. Further information has been requested.
Age: 1.3
Sex: F
Vaccine: DTPHIB, DTAP, HIBV
Symptoms: Abasia, Asthenia, Balance disorder, Cerebellar ataxia, Dyskinesia
Clinical narrative: Started having weakness and extrapyramidal symptoms with involuntary jerking movements of the head, extremity, and body. Need for hospitalization for 3 days. Continue to have weakness. The 60 day follow up received on 12/23/03 states balance problems: child unstable on her feet and unable to walk. Dx from hospitalization on 9/23/03: acute encephalopathy. Dx from hospitalization/ED visit on 11/25/03: acute cerebellar ataxia.
Age: 1.3
Sex: F
Vaccine: DTPHIB, DTAP, HIBV
Symptoms: Encephalopathy, Gait disturbance
Clinical narrative: Started having weakness and extrapyramidal symptoms with involuntary jerking movements of the head, extremity, and body. Need for hospitalization for 3 days. Continue to have weakness. The 60 day follow up received on 12/23/03 states balance problems: child unstable on her feet and unable to walk. Dx from hospitalization on 9/23/03: acute encephalopathy. Dx from hospitalization/ED visit on 11/25/03: acute cerebellar ataxia.
Age: 1.3
Sex: F
Vaccine: DTPHIB, DTAP, HIBV
Symptoms: Pyrexia, Tremor
Clinical narrative: Started having weakness and extrapyramidal symptoms with involuntary jerking movements of the head, extremity, and body. Need for hospitalization for 3 days. Continue to have weakness. The 60 day follow up received on 12/23/03 states balance problems: child unstable on her feet and unable to walk. Dx from hospitalization on 9/23/03: acute encephalopathy. Dx from hospitalization/ED visit on 11/25/03: acute cerebellar ataxia.
Age: 1.3
Sex: U
Vaccine: DTPHIB, DTAP, HIBV
Symptoms: Abasia, Asthenia, Balance disorder, Cerebellar ataxia, Dyskinesia
Clinical narrative: Trembling of neck and upper extremities and fever on 9/20/03. Treated with Tylenol or Motrin by parents. Child sx got worse and on 9/22/03 child was unable to stand. Parents took child to Dr. on 9/23/03. Doctor advised ED visit. Child hospitalized on 9/23/03.
Age: 1.3
Sex: U
Vaccine: DTPHIB, DTAP, HIBV
Symptoms: Encephalopathy, Gait disturbance
Clinical narrative: Trembling of neck and upper extremities and fever on 9/20/03. Treated with Tylenol or Motrin by parents. Child sx got worse and on 9/22/03 child was unable to stand. Parents took child to Dr. on 9/23/03. Doctor advised ED visit. Child hospitalized on 9/23/03.
Age: 1.3
Sex: U
Vaccine: DTPHIB, DTAP, HIBV
Symptoms: Pyrexia, Tremor
Clinical narrative: Trembling of neck and upper extremities and fever on 9/20/03. Treated with Tylenol or Motrin by parents. Child sx got worse and on 9/22/03 child was unable to stand. Parents took child to Dr. on 9/23/03. Doctor advised ED visit. Child hospitalized on 9/23/03.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Meningitis
Clinical narrative: Was admitted to hospital on 7/15/03 for spinal meningitis.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site oedema, Pruritus
Clinical narrative: On 03/01/03 had redness, itching, swelling in bicep area moving down left each day for 3 days with swelling increasing to forearm area. Lasted 4-5 days.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: Pt received influenza vaccine injection on 9/22/2003. The following morning, 9/24/03 pt noted raised wheal with erythema, urticaria and warmth at the injection site. Reaction subsided as the day progressed and no other problems noted.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Feeling hot, Injection site erythema, Injection site oedema, Pain
Clinical narrative: Area to left upper arm red, swollen, warm. Area approx 4.5" in length. C/o tenderness to area, less today than yesterday. Able to move arms diff. Return for exam today. Seen Dr., Dx cellulitis. Rx with Keflex.
Age: 1.25
Sex: F
Vaccine: DTAP, PNC
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Local reaction deltoid both arms erythema and min. induration.
Age: 27.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema, Pain
Clinical narrative: 9/4/03 called - arm sore, red, swollen. Advised to see private MD. She was seen in regional medical center either 9/4 or 9/5. Wound drain, drain inserted, drain inserted, put on antibiotics. Rechecked on 9/9/. Injection given 8/26/03.
Age: 1.57
Sex: F
Vaccine: DTAP, PNC
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Child received DTaP #4 and Prevnar on 09/17/03. Return to clinic 9/19/03 due to diffuse redness and swelling to anterior right thigh. No cellulitis. Dx as local reaction to vaccine.
Age: 2.0
Sex: F
Vaccine: HEPA, PNC
Symptoms: Injection site erythema, Injection site oedema, Pain, Urticaria
Clinical narrative: Hep A #1 and Prevnar #4 given to pt in left arm. Developed redness, swelling and pain left arm and was seen next day 9/24/03. Treated with Benadryl PO and Keflex PO. Pt then developed worsening urticaria on left arm with F/U. Pt was seen again 9/26/03 for F/U and had generalized urticaria and decreased of left arm. Tx with Prelone 2mg/kg for 5 days, Benadryl and Keflex.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Pt came in for a well exam on 9/25/03 at 9:00 AM and got a DTaP #5 in right thigh. Seen in our office again on 9/26/03 at 4:20 PM, had 4.5 x 2.5cm erythema and swelling on right outer thigh. This started the morning of 9/26/03.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Left arm red and swollen. Not painful at site. Dr looked at arm, stated normal reaction.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red area on right thigh hot to touch.
Age: 66.0
Sex: F
Vaccine: PPV, TD
Symptoms: Injection site erythema, Injection site inflammation, Pain
Clinical narrative: Pt received Td and Pneumovax on 9/29/03. Presents today with inflammation, pain and erythema at site of injection (Pneumo) extending to elbow.
Age: 53.0
Sex: F
Vaccine: PPV, TD
Symptoms: Injection site oedema, Pain
Clinical narrative: Right upper arm more swollen and tender. Went to ER and put on antibiotics (had previously taken Benadryl).
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Shot administered 8/8/03 (MMR), pt in 8/91/03 (per mom symptoms started 8/18/03) with diffuse mac-pap rash c/w measles.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Contusion, Injection site erythema, Injection site oedema, Pain
Clinical narrative: 8/1/03 left upper thigh with redness, swelling, bruising size 11.5cm x 6cm; c/o pain with palpation at injection site. Dr instructed Augmentin 400mg/5cc. 4cc po Bid for 10 days. Keep leg elevated with warm compresses and stat CBC, WBC.
Age: 18.0
Sex: M
Vaccine: HEP, TD
Symptoms: Convulsion, Cyanosis, Malaise
Clinical narrative: 3-5 minutes after receiving Td and HBV #1 pt "felt funny". Pt had active seizure with eyes and upper extremities involved. No resp effort. Cyanotic. Seizure lasted about 1-2 minutes. Color improved with opening of airway. After about 3 minutes pt became responsive.
Age: 0.08
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia, Rash maculo-papular
Clinical narrative: Light pink maculopapular rash starting face, palms and soles starting within 12 hours of vaccines. Low grade fever. Seen by physician. Tylenol PRN.
Age: 15.0
Sex: F
Vaccine: TD
Symptoms: Dizziness, Headache, Pain, Pyrexia
Clinical narrative: Within hours of shot, child c/o fever 100.5, aching all over and what she described as a severe headache as well as dizziness. Nurse told mother to contact MD as child described headache as not being "touched" by use of Tylenol and Ibuprofen. Mother telephoned RN next day. Child was fine. Never called MD.
Age: 4.0
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Agitation, Crying, Injection site erythema, Irritability, Pyrexia
Clinical narrative: Very irritable, crying fits, low-grade fever, redness at injection sites.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Redness and swelling on left upper arm (from about the shoulder to elbow - hot, inflamed and swollen). Started the morning after receiving shot. Tx: Advil, hot packs, etc.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth, Pain
Clinical narrative: Mother states day of vaccination child c/o of "sore arm". Next day mother states she noted "red and hard to touch". Upon examination erythema noted 60 x 60mm and mild swelling to right deltoid area. Child able to move arm without difficulty. Hot to touch. Advised to take Tylenol as directed for pain and Benadryl/cream or PO for local reaction PRN as directed and to use cool pack to site.
Age: 1.3
Sex: M
Vaccine: DTAP
Symptoms: Crying, Irritability, Oedema peripheral, Pyrexia, Somnolence
Clinical narrative: vomitting, swelling of leg, mild shaking, irritability, slight fever,sleepy,non-stop crying for more than an hour.
Age: 1.3
Sex: M
Vaccine: DTAP
Symptoms: Tremor, Vomiting
Clinical narrative: vomitting, swelling of leg, mild shaking, irritability, slight fever,sleepy,non-stop crying for more than an hour.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Eye movement disorder, Hypotension, Hypotonia, Rash erythematous
Clinical narrative: Approx 45 minutes after receiving vaccinations, parents noticed in the car that the child was making noises and suddenly stopped.  Mom looked back into the car seat and the child's eyes were "rolling back in his head."  Mom got out of the car and picked the child up and the child was noted to be "floppy."  She also stated that he was difficult to arouse for about 10 minutes and remained "not himself" approx 30 minutes afterwards.  Upon presentation to the ED, patient was eating and had no signs of residual neurologic symptoms.  It was noticed that he had a fine erythematous, blanchable rash on the face and neck. Thought this might be a hypotonic hyporesponsive episode secondary to vaccination. The hospital discharge received on 11/11/03 states hypotonia and hypotension.
Age: 48.0
Sex: M
Vaccine: SMALL
Symptoms: Analgesic effect, Asthenia, Biliary colic, Hyperplasia, Lymphadenopathy
Clinical narrative: 48 yo Caucasian male developed acute pain in bilateral inguinal areas on July 16, 2003, with pain along the length of his right lower extremity. He also had subjective weakness of right lower extremity, and subjectively altered sensation medial right thigh.  He was found to have tender lymphadenopathy (or tenderness without discernible adenopathy in the case of one axilla) in bilateral inguinal and axillary areas. He was admitted to the hospital (7/16 to 7/22) because of the severity of pain, and for diagnostic evaluation. Nodes were said to be "pea" to "acorn" size at that time. No constitutional symptoms were noted at that time.  Neurology and infectious disease consulted on his case. Despite multiple tests no explanation was found for his symptoms, which improved significantly in hospital.  He did well after discharge and returned to work, with apparent diminution of enlarged nodes. Symptoms increased again in August, and he was again hospitalized from 8/15-8/19. He reported about a week of feeling "run-down and achy"  He has apparently been requiring narcotics for analgesia since then, and has not returned to work as a security guard.  He recently went to the University of Iowa for another infectious disease consultation.   The vaccinee is convinced that his symptoms are related to his smallpox vaccination.  Current medications:  Topamax 100 bid (for chronic headaches) Fiorcet prn pain  Allergies: tetanus and beestings  PMH: history of smoke inhalation with ? h/o cardiac arrest vs MI, ? anoxic brain injury. Has memory deficits and chronic headaches. PSH knee arthroscopy, lumbar laminectomy, surgical repair of shrapnel injuries Bilat calves.  Extensive past travel history, none recent. History of some unprotected sexual encounters. Lymph node biopsy (July) showed follicular hyperplasia. Recent neg labs include HIV, tularemia, Lyme, CSD, Ehrlichia, CMV, Monoscreen, C-RP (less than 0.3) ESR (10), blood cultures (2),  AFB stains of lymph node, fungal and bacterial cultures of lymph node biopsy specimen (grew coagulase negative Staph aureus felt to be contaminant), ANA, Brucella,   WBCs normal eg 10.1, with unremarkable differential. Had 5.2% eosinophils in July on a single draw, but subsequently about 3%. Hgb 14.7 to 13.5., 258,000. CPK 66.  Lumbosacral MRI normal post-surgical changes. Brain MR 7/16 showed "vascular flow void in left vertebral and basilar arteries". CT scan chest to pelvis normal except one group of fairly small retroperitoneal nodes as noted above. The 60 day follow up received on 11/26/03 states the pt was ultimately diagnosed with lymphoma. Consensus of treating physicians is that lymphoma is not related to smallpox vaccination administered about 4 months before symptom onset. This has been discussed with CDC staff on smallpox detail. I have not been able to obtain pathology report.
Age: 48.0
Sex: M
Vaccine: SMALL
Symptoms: Lymphoma, Pain
Clinical narrative: 48 yo Caucasian male developed acute pain in bilateral inguinal areas on July 16, 2003, with pain along the length of his right lower extremity. He also had subjective weakness of right lower extremity, and subjectively altered sensation medial right thigh.  He was found to have tender lymphadenopathy (or tenderness without discernible adenopathy in the case of one axilla) in bilateral inguinal and axillary areas. He was admitted to the hospital (7/16 to 7/22) because of the severity of pain, and for diagnostic evaluation. Nodes were said to be "pea" to "acorn" size at that time. No constitutional symptoms were noted at that time.  Neurology and infectious disease consulted on his case. Despite multiple tests no explanation was found for his symptoms, which improved significantly in hospital.  He did well after discharge and returned to work, with apparent diminution of enlarged nodes. Symptoms increased again in August, and he was again hospitalized from 8/15-8/19. He reported about a week of feeling "run-down and achy"  He has apparently been requiring narcotics for analgesia since then, and has not returned to work as a security guard.  He recently went to the University of Iowa for another infectious disease consultation.   The vaccinee is convinced that his symptoms are related to his smallpox vaccination.  Current medications:  Topamax 100 bid (for chronic headaches) Fiorcet prn pain  Allergies: tetanus and beestings  PMH: history of smoke inhalation with ? h/o cardiac arrest vs MI, ? anoxic brain injury. Has memory deficits and chronic headaches. PSH knee arthroscopy, lumbar laminectomy, surgical repair of shrapnel injuries Bilat calves.  Extensive past travel history, none recent. History of some unprotected sexual encounters. Lymph node biopsy (July) showed follicular hyperplasia. Recent neg labs include HIV, tularemia, Lyme, CSD, Ehrlichia, CMV, Monoscreen, C-RP (less than 0.3) ESR (10), blood cultures (2),  AFB stains of lymph node, fungal and bacterial cultures of lymph node biopsy specimen (grew coagulase negative Staph aureus felt to be contaminant), ANA, Brucella,   WBCs normal eg 10.1, with unremarkable differential. Had 5.2% eosinophils in July on a single draw, but subsequently about 3%. Hgb 14.7 to 13.5., 258,000. CPK 66.  Lumbosacral MRI normal post-surgical changes. Brain MR 7/16 showed "vascular flow void in left vertebral and basilar arteries". CT scan chest to pelvis normal except one group of fairly small retroperitoneal nodes as noted above. The 60 day follow up received on 11/26/03 states the pt was ultimately diagnosed with lymphoma. Consensus of treating physicians is that lymphoma is not related to smallpox vaccination administered about 4 months before symptom onset. This has been discussed with CDC staff on smallpox detail. I have not been able to obtain pathology report.
Age: 0.53
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Convulsion, Encephalitis, Irritability, Meningitis, Pyrexia
Clinical narrative: High fever (103 degrees F), right focal seizures, meningitis. Received Dexamethasone, Cefotaxime, Vancomycin, Acyclovir. All cultures: positive HSV PCR positive; enterovirus PCR negative. Discharge Summary received on 10/07/2003 states fussy, rash, and encephalitis.
Age: 0.53
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Rash
Clinical narrative: High fever (103 degrees F), right focal seizures, meningitis. Received Dexamethasone, Cefotaxime, Vancomycin, Acyclovir. All cultures: positive HSV PCR positive; enterovirus PCR negative. Discharge Summary received on 10/07/2003 states fussy, rash, and encephalitis.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site inflammation, Injection site oedema
Clinical narrative: Pt with erythema/edema/pain and local inflammation at injection site.
Age: 47.0
Sex: F
Vaccine: TD
Symptoms: Hypersensitivity, Injection site erythema, Pain, Paraesthesia
Clinical narrative: 6/10/03 Left arm red, tender 15 x 8cm with altered sensation of the hand. Dx: Allergic reaction. Rx: Prednisone 20mg
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Anorexia, Malaise, Pain, Pyrexia, Rash
Clinical narrative: Within 1 hour of vaccine "not feel good". No appetite, drinks very little, fever onset several hours after shot to 104 degrees. Complains of while body hurt and legs. New circular 1 inch skin rash on arm today. Shots in left thigh.
Age: 1.42
Sex: F
Vaccine: DTPHIB, IPV, MMR, VARCEL
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Pt came in today 10/2/03 for PPD reading and showed left upper thigh was red, warm and swollen about 4 inches diameter, started last night.
Age: 17.0
Sex: M
Vaccine: HEP, IPV, MMR, TD
Symptoms: Injection site erythema, Pruritus, Rash
Clinical narrative: Pt states that 1 week after receiving vaccines he broke out in red patchy areas which itched. Pt raised his shirt and revealed healed site on chest wall and left VQ and right LE (brown patch) near ankle. Also stated he went to the beach same week.
Age: 3.0
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Bronchitis acute, Cough, Rales, Rash vesicular
Clinical narrative: Varicelliform eruption with about 25 spots (mostly papules, some vesicles). Onset 16 days post vaccination. Acute bronchitis, onset 18 days post vaccination, with cough, coarse rales and rhonchi throughout chest.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Left leg swollen red, warm to touch.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Pt in for vaccines 9/25/03 given a/o. No illnesses, no concerns. Returned to clinic 9/26/03, no temp (97 axillary). Seen by NP. 8cm circumference, left anterior thigh. Red, swollen area. Child eating, sleeping, acting well. Localized reaction. Cool compress, Tylenol, Benadryl if needed. To call if Sx worsened.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Swelling and erythema to vaccine site (left arm) noted several hours after vaccination. Resolving erythema without induration or tenderness noted by PMD on 9/11/03 at well child visit.
Age: 2.0
Sex: M
Vaccine: HEPA, HIBV, PNC
Symptoms: Feeling hot, Injection site erythema, Injection site haemorrhage
Clinical narrative: Left upper thigh reddened and warm approx 10 x 10cm area to right of area small dime size pinpoint ecchymotic area.
Age: 1.25
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Injection site erythema, Injection site induration, Petechiae, Pyrexia
Clinical narrative: 4-5 cm area of induration and erythema with some petechiae at margins, temp 102. No apparent infection, above all developed within 24 hours of getting PCV7 #4 and Varivax.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Pyrexia, Screaming
Clinical narrative: 9/10/03 vaccine given, 9/11/03 at 1:00 PM fever onset, fever for 24 hours with inconsolable screaming for 48 hours.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Infection
Clinical narrative: Broke out with chicken pox rash today, no treatment necessary.
Age: 3.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Bacterial infection, Pharyngitis, Pyrexia
Clinical narrative: Healthy 9/19/03 given DTaP, IPV. Strep, pharyngitis. 9/26 Rx'd with Amox. 9/28/03 Reported 107 degrees digital ear thermometer. 9/29/03 Tmax 101 degrees. Happy nontoxic.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Dx with chicken pox
Age: 30.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: 9/26/03-Erythem, swelling around injection site to elbow area.  Approximately 6 inches long by 2 inches wide. 9/27/03 ER-seen by physician.  Pt. on Keflex x10 days.
Age: 21.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Local Reaction to Anthrax Vaccination: Anthrax #4 (Left arm-deltoid area)Hep B #3 (Right arm) 29 Sept 03 Received vaccinations on this date.  No complaints.    30 Sept 03 Erythematous, edematous ring started to develop around site of anthrax vaccination.  Site tender to touch.  Service member reports no strenuous use of this arm since receiving the vaccination.  Denies any problems with previous 3 Anthrax vaccinations.  01 Oct 03 Enrolled in VHC services for evaluation.  Reports that the swelling and redness have decreased since the previous day.  No other complaints.   Treatment:  1. Ibuprofen 800mg po q8 hrs prn and diprolene topical steroid cream bid x 3-5 days. 2. Give future doses of anthrax vaccine via intramuscular route into deltoid muscle. 3. Pre-treat injection site with diprolene (or equivalent) topical steroid cream 1 hour prior to vaccination and bid x 3-5 days afterwards. 4. Ibuprofen 800 mg (or equivalent NSAID) 2 hours before receiving vaccine and tid x 3-5 days afterwards.   5. Avoid strenuous exercise for 24 to 48 hours after next dose to avoid aggravating local reaction.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Dyspnoea, Palpitations, Tremor
Clinical narrative: Vaccine administered at approximately 9:45 am.  Approx. 1 hour later patient "felt weak, felt like "heart was palpitating," had the shakes, was breathing hard and felt faint."  Wife states she took him to ER.  He was discharged with Benadryl and a "steroid pack."
Age: 59.0
Sex: M
Vaccine: TD
Symptoms: Contusion, Hyporeflexia, Laboratory test abnormal, Myalgia, Pain
Clinical narrative: dT vaccine administered 6/27/03.  Patient reported pain, swelling, bruise by 6/28/03.  Over next weeks, patient reported paresthesias from injection site into forearm on left upper extremity with associated myalgias.  Patient was treated conservatively initially with NSAIDS but with minimal improvement, tylenol #3 was used as well.  Lab evaluation revealed an elevated CRP but no other notable abnormalities.  Pain has persisted and worsened, and he was referred to Neurology for further evaluation.  The neurologist felt he had dysaesthersias in left arm with decreased relexes in distribution of C5-C7 concerning for a plexopathy related to vaccine associated edema, or possibly a demylinating neuropathy.  An MRI and an EMG have been ordered and are pending.
Age: 59.0
Sex: M
Vaccine: TD
Symptoms: Paraesthesia, Swelling
Clinical narrative: dT vaccine administered 6/27/03.  Patient reported pain, swelling, bruise by 6/28/03.  Over next weeks, patient reported paresthesias from injection site into forearm on left upper extremity with associated myalgias.  Patient was treated conservatively initially with NSAIDS but with minimal improvement, tylenol #3 was used as well.  Lab evaluation revealed an elevated CRP but no other notable abnormalities.  Pain has persisted and worsened, and he was referred to Neurology for further evaluation.  The neurologist felt he had dysaesthersias in left arm with decreased relexes in distribution of C5-C7 concerning for a plexopathy related to vaccine associated edema, or possibly a demylinating neuropathy.  An MRI and an EMG have been ordered and are pending.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Dyspnoea, Palpitations, Pharyngeal oedema
Clinical narrative: Mild shortness of breath, dizzyness and palpatations. Subjective feeling og throat swelling.
Age: 33.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site reaction, Injection site swelling, Oedema peripheral, Skin ulcer
Clinical narrative: Patient received primary smallpox vaccine on 1/29/03. On Day 14, he developed a large local reaction with swelling of the upper arm and extending to the elbow.  He was evaluated and dx. with a robust reaction to the vaccine.  The symptoms were self-limiting and resolved in 2-3 days.  Six months later, he noticed a change in the appearance of the vaccine scar.  The scar became raised with a papule lesion about the size of a dime.  In september, he noted a scant amount of serious drainage from the lesion.  He presented to KFB medical center for evaluation on  22 September 2003.  Denies, fever, lymphadenopathy,swelling, redness,streaking or rashes.  PCR for vaccinia, viral and bacterial cultures obtained.  Underwendt skin bisopsy by dermatology.
Age: 0.19
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Anorexia, Cerebral palsy, Lethargy, Respiratory distress
Clinical narrative: Had been not been nursing well during the night prior to vaccine.  Seen in clinic 8/22/02 with normal exam except slow gain.  Received DTaP, IPV and Comvax.  Over the next day became much more lethargic, evavuated for sepsis at ER and admitted to Hospital for 2 to 3 days.  No source of infection found.  Seen again 9/6/02. Gaining weight well.  Not seen again until 12/6/02 with severe failure to thrive readmitted to Hospital.  No diagnostic work up.  Has continued with increased developmental delay poor growth.  Episode of admission for sever resp distress.  Now diagnosis of cerbral palsy.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: I had my annual check up with my physician here on Sept 23rd.   They recommended and gave me the inoculation that day... it for people over 65.  Hives started soon after. The main itching and hives didn't show in full force until Sunday the 28th, but had probably been coming on and I didn't pay any attention to it.  Mon. I went back to the Dr. and she advised me to use  antihisimines.  She gave me a prescription for predispose but said try to get by with out it.  The break out has been just about everywhere on my body, not much on my face or in my hair.  In my crotch, legs, arms. hands, feet, back, front.  Today I decided to stop taking the antihistamine as the rash is settling down a lot .
Age: 50.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: no immunity conferred from series of 3 hepatitis B vaccinations from 1/23/03 - 7/22/03.
Age: 0.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: urticaria developed approx 10 hours after exam
Age: 3.0
Sex: M
Vaccine: HEPA, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Child received prevnar injection on Left thigh on 09/16/03.  Brought in by mother today 09/18/03.  Left thigh with approx. 100mm circular area red, warm and firm to touch.
Age: 37.0
Sex: M
Vaccine: ANTH, FLUX
Symptoms: Pruritus, Rash maculo-papular, Rash pruritic
Clinical narrative: 15 minutes after vacination of Anthrax and Flu, patient developed macular-papular puretic rash circumflexing his chest and upper extremities.  No angioedema, SOB, respiratory difficulty, or tachycardia.  Alert and orientient X 3, vital signs stable (115/72, 122/80) during entire event.  Only complaint was itchiness.  Given 50mg IM Benadryl and 4mg of Dexamethasone.  After 1/2 hour rash resolving, puritis resolving, and remained stable.  Patient released accompanied by co-worker.
Age: 37.0
Sex: F
Vaccine: TD, TD
Symptoms: Coma, Convulsion, Eye movement disorder, Genital discharge, Hypotension
Clinical narrative: From initial information received on 9/18/03 from a physician, regarding an adverse event occurring in the USA, it was reported that a patient (gender, age and birth date not provided) received a dose of DIPHTHERIA and TETANUS TOXOIDS (manufacturer, lot number, route and site not reported), on 9/16/03 at 1:30 AM. The same day, the patient experienced contractures, loss of consciousness, dilated pupils, seizure activity and muscle spasms. The patient was prescribed epinephrine, Solumedrol, and Benadryl. The recovery status was reported as unknown. Information received on 9/18/03 is not submitted to the health authorities since there is no identifiable patient. This specific information was requested to the reporting physician. The trade name of the specific vaccine administered is also not reported. From additional information received on 8/29/03 from an employee health nurse, it was reported that a 37 year old female patient received TD ADS ADULT, lot number U0827AA, IM in the right arm on 9/16/03. The patient also received a tuberculin skin test, manufacturer specified, lot number 1172P, in the left forearm. It was reported that the patient was not taking any medications at that time and did not have any illnesses at the time of vaccination. The patient was seen in the ER of the hospital and was treated with epinephrine, Solumedrol, Benadryl and Pepcid. It was reported that the patient has since recovered from these events.  (OMIC). Follow up on 03/22/04 states: "From additional information received 03/08/04 during a telephone conversation with the reporting nurse, the seizure started five minutes after the pt received the vaccine. The pt has had no further seizures and she has recovered.  It was recommended that the pt not receive any TD in the future.  No further information is anticipated. This case is considered closed."
Age: 37.0
Sex: F
Vaccine: TD, TD
Symptoms: Tachycardia, Tremor
Clinical narrative: From initial information received on 9/18/03 from a physician, regarding an adverse event occurring in the USA, it was reported that a patient (gender, age and birth date not provided) received a dose of DIPHTHERIA and TETANUS TOXOIDS (manufacturer, lot number, route and site not reported), on 9/16/03 at 1:30 AM. The same day, the patient experienced contractures, loss of consciousness, dilated pupils, seizure activity and muscle spasms. The patient was prescribed epinephrine, Solumedrol, and Benadryl. The recovery status was reported as unknown. Information received on 9/18/03 is not submitted to the health authorities since there is no identifiable patient. This specific information was requested to the reporting physician. The trade name of the specific vaccine administered is also not reported. From additional information received on 8/29/03 from an employee health nurse, it was reported that a 37 year old female patient received TD ADS ADULT, lot number U0827AA, IM in the right arm on 9/16/03. The patient also received a tuberculin skin test, manufacturer specified, lot number 1172P, in the left forearm. It was reported that the patient was not taking any medications at that time and did not have any illnesses at the time of vaccination. The patient was seen in the ER of the hospital and was treated with epinephrine, Solumedrol, Benadryl and Pepcid. It was reported that the patient has since recovered from these events.  (OMIC). Follow up on 03/22/04 states: "From additional information received 03/08/04 during a telephone conversation with the reporting nurse, the seizure started five minutes after the pt received the vaccine. The pt has had no further seizures and she has recovered.  It was recommended that the pt not receive any TD in the future.  No further information is anticipated. This case is considered closed."
Age: 37.0
Sex: F
Vaccine: TD, TD
Symptoms: Convulsion, Loss of consciousness, Muscle spasms, Mydriasis
Clinical narrative: From initial information received on 9/18/03 from a physician, regarding an adverse event occurring in the USA, it was reported that a patient (gender, age and birth date not provided) received a dose of DIPHTHERIA and TETANUS TOXOIDS (manufacturer, lot number, route and site not reported), on 9/16/03 at 1:30 AM. The same day, the patient experienced contractures, loss of consciousness, dilated pupils, seizure activity and muscle spasms. The patient was prescribed epinephrine, Solumedrol, and Benadryl. The recovery status was reported as unknown. Information received on 9/18/03 is not submitted to the health authorities since there is no identifiable patient. This specific information was requested to the reporting physician. The trade name of the specific vaccine administered is also not reported. From additional information received on 8/29/03 from an employee health nurse, it was reported that a 37 year old female patient received TD ADS ADULT, lot number U0827AA, IM in the right arm on 9/16/03. The patient also received a tuberculin skin test, manufacturer specified, lot number 1172P, in the left forearm. It was reported that the patient was not taking any medications at that time and did not have any illnesses at the time of vaccination. The patient was seen in the ER of the hospital and was treated with epinephrine, Solumedrol, Benadryl and Pepcid. It was reported that the patient has since recovered from these events.  (OMIC). Follow up on 03/22/04 states: "From additional information received 03/08/04 during a telephone conversation with the reporting nurse, the seizure started five minutes after the pt received the vaccine. The pt has had no further seizures and she has recovered.  It was recommended that the pt not receive any TD in the future.  No further information is anticipated. This case is considered closed."