chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: M
Vaccine: HEPA
Symptoms: Therapeutic response decreased
Clinical narrative: Antibody test negative. Information has been received from a physician concerning a 38 year old airman with no allergies and no pertinent medical history, who in February 2000, was vaccinated with a first dose hepatitis A virus vaccine inactivated (646789/0753N) and according to patient's chart shows that possibly, he was administered a 0.5ml dose of hepatitis A virus vaccine inactivated. In July 2004 he was vaccinated with a second dose (1.0ml) of hepatitis A virus vaccine inactivated. There was no concomitant medication. On 02-SEP-2005 a titer was non-reactive. The physician reported that he is unsure whether the first dose was incorrect or was charted incorrectly. It was noted therapy stopped after the July 2004 dose and the patient's outcome is not recovered. There was no product quality complaint reported. The patient sought unspecified medical attention. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: HEPA
Symptoms: Hepatic enzyme abnormal
Clinical narrative: Liver function test abnormal Information has been received from a registered nurse concerning a 42 year old female with  no known allergies or medical history who on 12-OCT-2004 was vaccinated IM in the left deltoid with a 1.0ml dose of hepatitis A virus vaccine inactivated. There was no concomitant medication. Subsequently, the patient had elevated liver function tests. Therapy with hepatitis A vaccine (inactive) was discontinued. Subsequently, the patient recovered from elevated liver function tests. It was unknown if medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: HEPA
Symptoms: Liver function test abnormal
Clinical narrative: Liver function test abnormal Information has been received from a health professional concerning a female who 6 months ago in approximately March 2005, was vaccinated with a 50u dose of hepatitis A virus vaccine inactivated. Subsequently the patient's liver function tests were elevated. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: HEPA
Symptoms: Rash erythematous, Rash macular
Clinical narrative: Rash macular; rash erythematous Information has been received from a physician assistant concerning a 57 year old female who on 08-SEP-2005 was vaccinated IM with a one milliliter dose of hepatitis A virus vaccine inactivated (lot #649456/0501R). On 09-SEP-2005 the patient experienced an erythematous macular rash limited mostly to her legs and arms. The rash has been treated with two IV methylprednisolone sodium succinate (Solu-Medrol) treatments, a methylprednisolone (MEDROL) dose pack and over the counter diphenhydramine (Benadryl). It was reported that improvement post treatment has been minimal. No other information was available. The patient is no recovered. There was no product quality complain reported. The patient sought unspecified medical attention. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: HEPA
Symptoms: Immunoglobulins increased
Clinical narrative: Blood immunoglobulin M increased Information has been received from a physician concerning a female patient in her 70's who was vaccinated with a dose of hepatitis A virus vaccine inactivated (date unspecified). Subsequently, the patient experienced elevated IGM antibody. Unspecified medical attention was sought. The physician reported that that was the only clinical factor for hepatitis that was evident. The patient's present status was reported as not recovered. No product quality complaint was involved.  Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Demyelination, Polyneuropathy
Clinical narrative: Information has been received from a physician concerning a pt who was vaccinated with a dose of hep A virus vaccine inactivated on an unspecified date. It was reported that the pt developed chronic inflammatory demyelinating polyneuropathy. Unspecified medical attention was sought. There was no information regarding this pt's present status. No product quality complaint was involved. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Drug ineffective, Hepatitis A, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 50 year old male who in Mar 2004, was vaccinated with the first dose of hep A virus vaccine inactivated. Concomitant therapy included zolpidem tartrate (Ambien). In July 2005, the pt received the second dose of hep A virus vaccine inactivated (lot 649456/0174R). On 22Oct05 (previously reported as an unspecified date), the pt developed asymptomatic Hep A. The pt sought unspecified medical attention. At the time of this report, the outcome of the event was unk. Follow up was received from the nurse on 11Nov05. The pt was a white male with allergic rhinitis and a family a history of prostate, skin, and colon cancer, heart murmur (mother and father), and multiple lipomas. On 19Jul05 at 4:00PM, he was vaccinated with the second dose of hep A virus vaccine inactivated (lot 649456/0174R), IM into the left arm and with the third dose of hep B virus vaccine rHBsAg (yeast) (lot 647548/0032P), IM into the right arm. He had no adverse events following prior vaccinations and no illness at the time of vaccination. The nurse reported that lab work done on 22Oct05 came back with a positive hep A result. He was not symptomatic of hep C signs/symptoms pt feels fine. On 27Oct05, the pt again tested reactive for hep A, and was negative for hep C. He was to make an appt with ID (infectious disease) as soon as possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: FLUX, HEPA
Symptoms: Cough, Eye swelling, Ocular hyperaemia, Pruritus, Pyrexia
Clinical narrative: Information has been received from an approx 40 yr old female physician who on 24Oct05 was vaccinated SC with a 0.5ml, second dose of hep A virus vaccine inactivated (lot646790/0693N). Concomitant therapy included influenza virus vaccine (unspecified) and tuberculin purified protein derivative. On 24Oct05 the pt developed blood red eyes, swollen eyes, itchy eyes, swollen tongue and cough approx 1-2 hrs after the dose. She was treated with diphenhydramine hydrochloride (Benadryl) after which a fever developed. As of 28Oct05, she had recovered from the events. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: FLUX, HEPA
Symptoms: Tongue oedema
Clinical narrative: Information has been received from an approx 40 yr old female physician who on 24Oct05 was vaccinated SC with a 0.5ml, second dose of hep A virus vaccine inactivated (lot646790/0693N). Concomitant therapy included influenza virus vaccine (unspecified) and tuberculin purified protein derivative. On 24Oct05 the pt developed blood red eyes, swollen eyes, itchy eyes, swollen tongue and cough approx 1-2 hrs after the dose. She was treated with diphenhydramine hydrochloride (Benadryl) after which a fever developed. As of 28Oct05, she had recovered from the events. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: HEPA
Symptoms: Inflammation
Clinical narrative: Information has been received from a physician concerning a 7 year old female who was vaccinated with hep A virus vaccine inactivated. The physician reported that the pt had previously been vaccinated with hep A virus vaccine inactivated (Havrix) for their first hep A dose and then received hep A virus vaccine inactivated for the second dose. Subsequently, the pt experienced swelling and inflammation. The physician reported that the pt sought unspecified medical attention. Additional information is expected.
Age: 4.0
Sex: M
Vaccine: HEPA
Symptoms: Inflammation
Clinical narrative: Information has been received from a physician concerning a 4 yr old male who was vaccinated with hep A virus vaccine inactivated. The physician reported that the pt was previously vaccinated with hep A virus vaccine inactivated (Havrix) for their first hep A dose and received hep A virus vaccine inactivated for their second dose. Subsequently the pt experienced swelling and inflammation. The pt sought unspecified medical attention. Additional information is expected.
Age: 20.0
Sex: U
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning an adult pt aged 20-25 years who was vaccinated with hep A virus inactivated. The physician reported that the pt was previously vaccinated with hep A virus vaccine inactivated (Havrix) for their first hep A dose and received hep A virus vaccine inactivated for their second dose. Subsequently the pt experienced fever. The physician reported that the pt sought unspecified medical attention. Additional information is expected.
Age: 20.0
Sex: U
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning an adult pt aged 20-25 who was vaccinated with hep A virus vaccine inactivated. The physician reported that the pt had been previously vaccinated with hep A virus vaccine inactivated (Havrix) for their first hep A dose and then received hep A virus vaccine inactivated for their second dose. Subsequently the pt experienced fever. The physician reported that the pt sought unspecified medical help. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning an adult pt who was vaccinated with hep A virus vaccine inactivated. The physician reported that the pt had previously been vaccinated with hep A virus vaccine inactivated (Havrix) for their first hep A dose and received hep A virus vaccine inactivated for their second dose. Subsequently the pt experienced injection site pain. The pt sought unspecified medical attention. Additional information is expected.
Sex: U
Vaccine: HEPA
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning an adult pt who was vaccinated with hep A virus vaccine inactivated. The physician reported that the pt was previously vaccinated with hep A virus vaccine inactivated (Havrix) for their first hep A dose and then received hep A virus vaccine inactivated for their second dose. Subsequently the pt experienced injection site pain. The physician reported that the pt sought unspecified medical attention. Additional information is expected.
Sex: U
Vaccine: HEPA
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning an adult pt who was vaccinated with hep A virus vaccine inactivated. The physician reported that the pt had previously been vaccinated with hep A virus vaccine inactivated (Havrix) for their first hep A dose and then received hep A virus vaccine inactivated for their second dose. Subsequently the pt experienced injection site pain. The physician reported that the pt sought unspecified medical attention. Additional information is expected.
Age: 6.0
Sex: F
Vaccine: FLUX, HEPA
Symptoms: Urticaria
Clinical narrative: Information has been received from a health professional concerning a 5 yr old female child with no pertinent medical history or allergies who on 20OCT05 was vaccinated with hep A virus vaccine inactivated (lot649459/0287R). Concomitant therapy included influenza virus vaccine (unspecified) (dose not reported). On 20Oct05, 2 hrs after the pt received her first hep A virus vaccine inactivated and flu vaccine in different arms, the pt developed hives. She was treated was diphenhydramine hydrochloride (Benadryl). No lab tests were required. Subsequently about 2 hrs after the vaccine, the pt recovered from hives. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTP, HEPA, IPV
Symptoms: Eyelid oedema
Clinical narrative: Information has been received from a health professional concerning a 4 yr old female who on 16Dec05 was vaccinated with hep A virus vaccine inactivated (lot649459/0287R) and diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid and poliovirus vaccine in different locations. The night of 16Dec05 the pt experienced swelling of both upper and lower eyelids. The pt received diphenhydramine (Benadryl) and recovered from swelling both upper and lower eyelids the next morning. This was the first dose of Vaqta, but she had received the other two vaccines in the past without reaction. Additional information is not expected.
Age: 53.0
Sex: F
Vaccine: HEPA
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a RN concerning a female with allergy to some preservatives who in approx 2005 (recently) was vaccinated with hep A virus vaccine inactivated. The nurse reported that the pt was having an allergic reaction to something. The nurse was not sure if the hep A virus vaccine inactivated was the cause. She said the pt was going to undergo allergy testing. The outcome was reported as not recovered. Additional information is not expected.
Age: 30.0
Sex: M
Vaccine: HEPA
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a physician and registered nurse concerning a 30 yr old male who on 10Dec05 was vaccinated with the first dose of hep A virus vaccine inactivated. According to the nurse, approx three weeks following the vaccination a hep antibody test was performed. She was not sure why the test was performed at this early date. It revealed that the pt failed to seroconvert. On approx 18Jan06, the pt saw a different physician at an outpt clinic and at that visit was vaccinated with the second dose of hep A vaccine (mfr unk) as well as with hep B vaccine (mfr unk). Later that day the pt experienced an unspecified reaction. The nurse felt that the reaction was due to having both vaccinations on the same day. She had no further details on the reaction type and severity. The outcome was unk. She did report that the pt was not hospitalized since the first vaccination with hep A virus vaccine inactivated on 10Dec05 (initially reported as hospitalized for unrelated health issue). Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a pharmacist concerning a pt with HIV disease who was vaccinated with a first and second dose of hep A virus vaccine inactivated. In Nov 2005, the pt had a recent titer which failed to show seroconversion. Unspecified medical attention was sought. There was no product quality complaint involved. It was reported that the pt failed to show seroconversion following hep B virus vaccine rHBsAg (yeast) (WAES0511USA03543). Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: HEPA
Symptoms: Headache, Vomiting
Clinical narrative: Information has been received from a RN concerning a pt (age and sex not reported) who on an unspecified date was vaccinated with hep A virus vaccine inactivated (lot651877/0705R). In Feb 2006, the pt experienced severe headaches and was vomiting within a few hours of receiving their first dose of hep A virus vaccine. The pt sought unspecified medical attention. Subsequently, the pt recovered from severe headaches and vomiting. Follow up information was received from the RN. The pt was a nine yr old female student with no illness at the time of vaccination and no preexisting allergies, birth defects or medical conditions, and no history of adverse event following prior vaccinations. On 07Feb06 at 10:30AM, the pt was vaccinated with her first dose of hep A virus vaccine inactivated (lot651877/0706R), IM in left arm. The pt had a headache and one episode of vomiting on the evening of vaccine given (onset time 8:00PM). No headache or vomiting after going to sleep that night. On 08Feb06, the pt recovered. She attended school the next day following the vaccination. No further information is expected.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Bacterial infection, Blood albumin decreased, Blood bilirubin increased
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 yr old female who on 22Jan06 was vaccinated with hep A virus vaccine inactivated, 0.5mL once. There was no concomitant medication. On 14Jan06 the pt experienced elevated liver enzymes after vaccination with hep A virus vaccine inactivated. She was vaccinated to go on a church mission trip. The nurse practitioner suspected the pt had a salmonella infection as well as hep A. The nurse practitioner also stated the pt was really sick. Medical attention was sought. The pt was reported as not recovered. Follow up was received from the nurse practitioner on 20Mar06 concerning this 16 yr white female who on 16Feb06 was evaluated for fever, vomiting, and diarrhea. On lab tests performed for these symptoms it was noted that the pt had slightly elevated liver functions (ALT 72 IU/L, AST 58 IU/L, bilirubin total 1.2 mg/dL, bilirubin direct 0.48mg/dL), negative hep A IgM, reactive hep A antibodies, and stool culture positive for salmonella. Follow up labs were not required. On an unspecified date, the pt recovered from the events. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Diarrhoea, Hepatic enzyme abnormal, Pyrexia, Sepsis, Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 yr old female who on 22Jan06 was vaccinated with hep A virus vaccine inactivated, 0.5mL once. There was no concomitant medication. On 14Jan06 the pt experienced elevated liver enzymes after vaccination with hep A virus vaccine inactivated. She was vaccinated to go on a church mission trip. The nurse practitioner suspected the pt had a salmonella infection as well as hep A. The nurse practitioner also stated the pt was really sick. Medical attention was sought. The pt was reported as not recovered. Follow up was received from the nurse practitioner on 20Mar06 concerning this 16 yr white female who on 16Feb06 was evaluated for fever, vomiting, and diarrhea. On lab tests performed for these symptoms it was noted that the pt had slightly elevated liver functions (ALT 72 IU/L, AST 58 IU/L, bilirubin total 1.2 mg/dL, bilirubin direct 0.48mg/dL), negative hep A IgM, reactive hep A antibodies, and stool culture positive for salmonella. Follow up labs were not required. On an unspecified date, the pt recovered from the events. Additional information is not expected.
Age: 0.21
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Atrial septal defect, Hypoxia, Patent ductus arteriosus, Pulmonary oedema
Clinical narrative: Pt received vaccine on 3/20/06. Pt expired at home on 3/22/06. 7/10/06 Received autopsy report which revealed COD as persistence of fetal circulation/ss
Age: 1.05
Sex: M
Vaccine: VARCEL
Symptoms: Abnormal behaviour, Coma, Diarrhoea, Hypersensitivity, Opisthotonus
Clinical narrative: Information has been received from a health professional concerning her 12 month old son, with no medical history and no allergies, who on 3/15/2005 was vaccinated with a dose of varicella virus vaccine live (lot 647536/0825P). Concomitant vaccine administered on the same day included a dose of measles mumps rubella vaccine (lot 648606/0558P). The next day, on 3/16/2005 the patient experienced a fever. One week later, on approximately 3/22/2005, the patient developed diarrhea, his speech decreased, he became sensitive to foods, did not respond to people, and began banging his head and arching his back. The patient had been treated by a nutritionist and many other medical specialists (unspecified). He had been treated with pancreatic enzymes, bacteria for his gut, and holistic vitamins. Diagnostic studies were performed (no results provided). An endoscopy and colonoscopy were planned. It was reported that the patient had been to the emergency room several times. At the time of the report the patient had not recovered. No product quality complaint was involved. The patients reaction was considered to be immediately life threatening, disabling, and an other important medical event by the reporter (OMIC). Additional information has been requested. A lot check has been requested. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released.
Age: 1.05
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Speech disorder
Clinical narrative: Information has been received from a health professional concerning her 12 month old son, with no medical history and no allergies, who on 3/15/2005 was vaccinated with a dose of varicella virus vaccine live (lot 647536/0825P). Concomitant vaccine administered on the same day included a dose of measles mumps rubella vaccine (lot 648606/0558P). The next day, on 3/16/2005 the patient experienced a fever. One week later, on approximately 3/22/2005, the patient developed diarrhea, his speech decreased, he became sensitive to foods, did not respond to people, and began banging his head and arching his back. The patient had been treated by a nutritionist and many other medical specialists (unspecified). He had been treated with pancreatic enzymes, bacteria for his gut, and holistic vitamins. Diagnostic studies were performed (no results provided). An endoscopy and colonoscopy were planned. It was reported that the patient had been to the emergency room several times. At the time of the report the patient had not recovered. No product quality complaint was involved. The patients reaction was considered to be immediately life threatening, disabling, and an other important medical event by the reporter (OMIC). Additional information has been requested. A lot check has been requested. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released.
Age: 0.76
Sex: F
Vaccine: HEP, HEPA
Symptoms: Medication error
Clinical narrative: Patient given hepatitis A vaccine prematurely. No adverse reactions noted.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site warmth, Pruritus, Rash
Clinical narrative: 24 hours after vaccine bright red, rash appeared-very hot to touch @ site, itching 19X10cm rt hip.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Lymphadenopathy, Nausea, Pain, Pyrexia
Clinical narrative: SWOLLEN AND PAINFUL AXILLARY, NECK AND CHEST GLANDS STARTED ON SAT 05/27/06. PT VOICED THAT SHE CALLED FOR ADVICE ON SAT WAS TOLD TO TAKE TYLENOL FOR PAIN AND IF SHE BECAME FEVERISH SHE SHOULD THEN GO TO E.R. PT VOICED TODAY SHE STILL HAS SWOLLEN GLANDS SLIGHTLY LESS THAN SAT NOT AS PAINFUL. TODAY PT VOICED SHE FEELS NAUSEATED AND TIRED. PT HAS BEEN USING TYLENOL CONSISTENTLY FOR PAIN.
Age: 67.0
Sex: F
Vaccine: HEPA, IPV, TDAP, TYP
Symptoms: Muscle spasms
Clinical narrative: Later in the day had cramping in her hips and ankles.
Age: 0.09
Sex: M
Vaccine: HEP
Symptoms: Cough, Depressed level of consciousness, Heart rate increased, Hypotonia, Hypoventilation
Clinical narrative: An hour after the hep B shot was given to my child, he dropped limp in my arms and was lethargic. We were unable to wake him. He had shallow breathing with a fast heart rate. A week afterHep B shot, He had cold like symptoms, Stuffy nose, cough, sneezing. He also continues to have brief lethargic states with blank stares.
Age: 0.09
Sex: M
Vaccine: HEP
Symptoms: Lethargy, Nasal congestion, Sneezing, Staring
Clinical narrative: An hour after the hep B shot was given to my child, he dropped limp in my arms and was lethargic. We were unable to wake him. He had shallow breathing with a fast heart rate. A week afterHep B shot, He had cold like symptoms, Stuffy nose, cough, sneezing. He also continues to have brief lethargic states with blank stares.
Age: 30.0
Sex: F
Vaccine: MEA
Symptoms: Injection site erythema, Injection site rash, Injection site warmth, Pyrexia
Clinical narrative: Pt started having a red rash and warmness at the site of injection 2 days after and low grade fever resolving with Tylenol.
Age: 22.0
Sex: M
Vaccine: JEV
Symptoms: Chills, Headache
Clinical narrative: 7 days after completing the 3rd vaccine for Japanese Encephalitis, pt. awoke c/o chills and headache which lasted for 2 days.
Age: 59.0
Sex: F
Vaccine: MMR
Symptoms: Hypoaesthesia, Paraesthesia, Swelling
Clinical narrative: 052506 1350 PM Telephone call to client, as RN had a report that this client had numbness and tingling in her arm following an MMR.  Client reports she had tingling and swelling in her left arm just above her elbow and she noticed this almost right after the MMR.  Indicates that the tingling and swelling are better and now her arm feels a little prickly.  Client denied any numbness.  This client didn't report this while at the MMR Clinic.
Age: 17.0
Sex: F
Vaccine: YF
Symptoms: Pruritus, Urticaria
Clinical narrative: Approx. 6-7 hours after receiving yellow fever vaccine, client noted "hives" on lower legs with intense itching. Benadryl tab taken @ hs. Next day noted increase in number of hives on legs & also around injection site on arm. To dermatologist 5/26 who felt hives do to yellow fever vaccine. 5/31, per mother, hives fading in color, but not in number.  Hives have remained localized on legs between ankles & knees.  Itching has decreased, using topical cream from dermatologist.
Age: 1.56
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Injury, Medication error
Clinical narrative: Child jerked when vaccine administered the Hib vaccine causing the needle to be withdrawn while med was administered, and puncturing his leg again on 5/26/06.  Mother called on 5/30/06 stating site is inflamed, reddened, swollen and painful to touch.  Advised to apply warm packs and give Tylenol.  Mother took child to her family physician on 5/30/06 who prescribed an antibiotic in case of infection.
Age: 1.56
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC
Symptoms: Pain
Clinical narrative: Child jerked when vaccine administered the Hib vaccine causing the needle to be withdrawn while med was administered, and puncturing his leg again on 5/26/06.  Mother called on 5/30/06 stating site is inflamed, reddened, swollen and painful to touch.  Advised to apply warm packs and give Tylenol.  Mother took child to her family physician on 5/30/06 who prescribed an antibiotic in case of infection.
Age: 0.85
Sex: F
Vaccine: HEP, IPV
Symptoms: Tongue paralysis
Clinical narrative: This case was reported by a consumer and described the occurrence of slowing of tongue movement in a 10 month old female subject who received hepatitis B vaccine recombinant Engerix B plus a separate injection of poliomyelitis virus vaccine IPOL. On 5/22/2006 the patient received the first dose of Engerix lot number not provided. On 5/22/2006 the subject also received a separate injection of poliomyelitis virus vaccine Ipol. Approximately four following the administration of Engerix B on 5/22/2006 the subject experienced slowing of tongue movement. The outcome of the event had worsened the following day.
Age: 1.29
Sex: M
Vaccine: DTAP, HEP
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: Swelling redness to injection site within 24 hours of vaccine given decreased redness and swelling about 4 days after vaccine given.
Age: 41.0
Sex: M
Vaccine: MMR
Symptoms: Aggression, Aphasia, Asthenia, Headache
Clinical narrative: 5/22/06 Severe headache treated with analgesics at home. 5/23/06 Weak, uptunded, combative and admitted. Aphasia. Rule out encephalitis vs vaccine reaction. Received MMR on about 5/16/06. ? where. Pt discharged from hospital 5/27/06, fully recovered.
Age: 1.03
Sex: M
Vaccine: IPV, VARCEL
Symptoms: Infection
Clinical narrative: Limited number of vesicles on face and right arm. topical Umbilical lesions.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HEP, HIBV, IPV, PNC
Symptoms: Injection site haemorrhage
Clinical narrative: Hematoma to L lateral thigh. Still present.
Age: 1.41
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Infection transmission via personal contact
Clinical narrative: Pt exposed to child with varicella. Broke out with varicella rash.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Blister, Dermatitis, Irritability, Pain, Pruritus
Clinical narrative: Very irritated with sore of blisters from my head to feet A/C over my body end pack kept you up a day and a half of no sleep of hurting all over and itching and itching. Lidex cream and clobetasol, Gentamicin, ointment and Dapsone 100mg tab 2x day, Prednisone 40 mg.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Similar reaction on previous exposure to drug
Clinical narrative: Very irritated with sore of blisters from my head to feet A/C over my body end pack kept you up a day and a half of no sleep of hurting all over and itching and itching. Lidex cream and clobetasol, Gentamicin, ointment and Dapsone 100mg tab 2x day, Prednisone 40 mg.
Age: 12.0
Sex: F
Vaccine: TDAP, TD
Symptoms: Dizziness, Facial palsy
Clinical narrative: Vaccine 4/18/06, ER 4/25/06 diagnosed with bells palsy on right side of body, prescribed acyclovir and Prednisone, as of 5/7/06 has not gone away.
Age: 12.0
Sex: F
Vaccine: TDAP, TD
Symptoms: Facial palsy
Clinical narrative: Vaccine 4/18/06, ER 4/25/06 diagnosed with bells palsy on right side of body, prescribed acyclovir and Prednisone, as of 5/7/06 has not gone away.
Age: 44.0
Sex: F
Vaccine: HEP, TD, HEP, TD, HEP, TD
Symptoms: Bedridden, Complex regional pain syndrome, Condition aggravated, Dizziness, Hemiparesis
Clinical narrative: Began getting headaches after the shots (W/in hours). H/A became more severe, symptoms increased. Unable to work since 9/13/05. Pain, stress, nausea, photophobia, digestive elimination problems. Also facial redness, swelling. Symptoms continued to increase. In Dec 05 included right arm and right leg. Difficulty walking, cane, wheelchair, bedridden.  Complex Regional Pain Syndrome (face, rt arm, rt leg) Disabled. Bedridden 90-95% of time with mod-severe chronic pain. (I had pre-existing facial neuralgia and an allergy to sulfur biproducts. Vaccine contain sulfate). Please see attached pages of deposition of the medical examiner Depo 4-19-07 pgs 5-16, 49-52. (Also pkg insert for Septocaine Depo pg 49) that shows it causes damage to trigeminal nerve.
Age: 44.0
Sex: F
Vaccine: HEP, TD, HEP, TD, HEP, TD
Symptoms: Hypokinesia, Injection site pain, Injection site rash, Pain, Photophobia
Clinical narrative: Began getting headaches after the shots (W/in hours). H/A became more severe, symptoms increased. Unable to work since 9/13/05. Pain, stress, nausea, photophobia, digestive elimination problems. Also facial redness, swelling. Symptoms continued to increase. In Dec 05 included right arm and right leg. Difficulty walking, cane, wheelchair, bedridden.  Complex Regional Pain Syndrome (face, rt arm, rt leg) Disabled. Bedridden 90-95% of time with mod-severe chronic pain. (I had pre-existing facial neuralgia and an allergy to sulfur biproducts. Vaccine contain sulfate). Please see attached pages of deposition of the medical examiner Depo 4-19-07 pgs 5-16, 49-52. (Also pkg insert for Septocaine Depo pg 49) that shows it causes damage to trigeminal nerve.
Age: 44.0
Sex: F
Vaccine: HEP, TD, HEP, TD, HEP, TD
Symptoms: Swelling, Thermal burn
Clinical narrative: Began getting headaches after the shots (W/in hours). H/A became more severe, symptoms increased. Unable to work since 9/13/05. Pain, stress, nausea, photophobia, digestive elimination problems. Also facial redness, swelling. Symptoms continued to increase. In Dec 05 included right arm and right leg. Difficulty walking, cane, wheelchair, bedridden.  Complex Regional Pain Syndrome (face, rt arm, rt leg) Disabled. Bedridden 90-95% of time with mod-severe chronic pain. (I had pre-existing facial neuralgia and an allergy to sulfur biproducts. Vaccine contain sulfate). Please see attached pages of deposition of the medical examiner Depo 4-19-07 pgs 5-16, 49-52. (Also pkg insert for Septocaine Depo pg 49) that shows it causes damage to trigeminal nerve.
Age: 44.0
Sex: F
Vaccine: HEP, TD, HEP, TD, HEP, TD
Symptoms: Abasia, Anxiety, Difficulty in walking, Dyspepsia, Erythema
Clinical narrative: Began getting headaches after the shots (W/in hours). H/A became more severe, symptoms increased. Unable to work since 9/13/05. Pain, stress, nausea, photophobia, digestive elimination problems. Also facial redness, swelling. Symptoms continued to increase. In Dec 05 included right arm and right leg. Difficulty walking, cane, wheelchair, bedridden.  Complex Regional Pain Syndrome (face, rt arm, rt leg) Disabled. Bedridden 90-95% of time with mod-severe chronic pain. (I had pre-existing facial neuralgia and an allergy to sulfur biproducts. Vaccine contain sulfate). Please see attached pages of deposition of the medical examiner Depo 4-19-07 pgs 5-16, 49-52. (Also pkg insert for Septocaine Depo pg 49) that shows it causes damage to trigeminal nerve.
Age: 44.0
Sex: F
Vaccine: HEP, TD, HEP, TD, HEP, TD
Symptoms: Face oedema, Headache, Hepatocellular damage, Hypovitaminosis, Nausea
Clinical narrative: Began getting headaches after the shots (W/in hours). H/A became more severe, symptoms increased. Unable to work since 9/13/05. Pain, stress, nausea, photophobia, digestive elimination problems. Also facial redness, swelling. Symptoms continued to increase. In Dec 05 included right arm and right leg. Difficulty walking, cane, wheelchair, bedridden.  Complex Regional Pain Syndrome (face, rt arm, rt leg) Disabled. Bedridden 90-95% of time with mod-severe chronic pain. (I had pre-existing facial neuralgia and an allergy to sulfur biproducts. Vaccine contain sulfate). Please see attached pages of deposition of the medical examiner Depo 4-19-07 pgs 5-16, 49-52. (Also pkg insert for Septocaine Depo pg 49) that shows it causes damage to trigeminal nerve.
Age: 44.0
Sex: F
Vaccine: HEP, TD, HEP, TD, HEP, TD
Symptoms: Oedema, Pain, Photophobia
Clinical narrative: Began getting headaches after the shots (W/in hours). H/A became more severe, symptoms increased. Unable to work since 9/13/05. Pain, stress, nausea, photophobia, digestive elimination problems. Also facial redness, swelling. Symptoms continued to increase. In Dec 05 included right arm and right leg. Difficulty walking, cane, wheelchair, bedridden.  Complex Regional Pain Syndrome (face, rt arm, rt leg) Disabled. Bedridden 90-95% of time with mod-severe chronic pain. (I had pre-existing facial neuralgia and an allergy to sulfur biproducts. Vaccine contain sulfate). Please see attached pages of deposition of the medical examiner Depo 4-19-07 pgs 5-16, 49-52. (Also pkg insert for Septocaine Depo pg 49) that shows it causes damage to trigeminal nerve.
Age: 44.0
Sex: F
Vaccine: HEP, TD, HEP, TD, HEP, TD
Symptoms: Condition aggravated, Hemiparesis, Hypokinesia, Pain, Skin burning sensation
Clinical narrative: Began getting headaches after the shots (W/in hours). H/A became more severe, symptoms increased. Unable to work since 9/13/05. Pain, stress, nausea, photophobia, digestive elimination problems. Also facial redness, swelling. Symptoms continued to increase. In Dec 05 included right arm and right leg. Difficulty walking, cane, wheelchair, bedridden.  Complex Regional Pain Syndrome (face, rt arm, rt leg) Disabled. Bedridden 90-95% of time with mod-severe chronic pain. (I had pre-existing facial neuralgia and an allergy to sulfur biproducts. Vaccine contain sulfate). Please see attached pages of deposition of the medical examiner Depo 4-19-07 pgs 5-16, 49-52. (Also pkg insert for Septocaine Depo pg 49) that shows it causes damage to trigeminal nerve.
Age: 1.02
Sex: F
Vaccine: HIBV, MMR, VARCEL, HIBV, MMR, VARCEL
Symptoms: Pyrexia, Restlessness, Rhinorrhoea
Clinical narrative: 1st night temp 103, restless, fussy, low grade temp next day, 2nd night temp 102, restless, fussy, up all night crying, kicking legs. Continued with temp off and on for up to 10 days, diarrhea, restless, fussy, poor appetite, runny nose, hyperactive bowel sounds, temp 104 on day 9. Went to family MD on following Tuesday and back to Pediatrician on Monday 5/8/06.
Age: 1.02
Sex: F
Vaccine: HIBV, MMR, VARCEL, HIBV, MMR, VARCEL
Symptoms: Bowel sounds abnormal, Crying, Decreased appetite, Diarrhoea, Insomnia
Clinical narrative: 1st night temp 103, restless, fussy, low grade temp next day, 2nd night temp 102, restless, fussy, up all night crying, kicking legs. Continued with temp off and on for up to 10 days, diarrhea, restless, fussy, poor appetite, runny nose, hyperactive bowel sounds, temp 104 on day 9. Went to family MD on following Tuesday and back to Pediatrician on Monday 5/8/06.
Age: 1.02
Sex: F
Vaccine: HIBV, MMR, VARCEL, HIBV, MMR, VARCEL
Symptoms: Irritability, Pyrexia, Restlessness, Rhinorrhoea, Screaming
Clinical narrative: 1st night temp 103, restless, fussy, low grade temp next day, 2nd night temp 102, restless, fussy, up all night crying, kicking legs. Continued with temp off and on for up to 10 days, diarrhea, restless, fussy, poor appetite, runny nose, hyperactive bowel sounds, temp 104 on day 9. Went to family MD on following Tuesday and back to Pediatrician on Monday 5/8/06.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site warmth
Clinical narrative: Right upper arm with redness, warm to touch, swollen, Placed on Keflex 250/5 1 1/2 tsp TID x 10days.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Mom called 5/28/0-fever 103.5. No cold sx. No GI sx. Temperature decreased with Ibuprofen. No rash. ER 5/29-fever 104. CBC-nml, UA-nml. BMP-Glu 66. Rocephin/fluids-Home. Seen doctor 5/30, diarrhea 3-4 X day. 5/31-fever 101. Doing better.
Age: 22.0
Sex: F
Vaccine: YF
Symptoms: Disorientation, Dizziness, Headache, Myalgia, Pyrexia
Clinical narrative: Fever, muscle aches, HA, diarrhea, lightheadedness, fainted and disoriented.
Age: 22.0
Sex: F
Vaccine: YF
Symptoms: Syncope, Viral infection
Clinical narrative: Fever, muscle aches, HA, diarrhea, lightheadedness, fainted and disoriented.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Erythema, Rash maculo-papular, Rash pruritic
Clinical narrative: A report was received of itchy rash coincident to FluMist. An eight year old female received FluMist vaccine sometime between 12/29/2005 and 6/02/2006. In the evening of 1/4/2006, the child developed a rash and was seen by a physician on 1/6/2006. The rash was described as an itchy, erythematous, maculo papular rash primarily located on the upper and lower extremities and the trunk. The child had no fever, cough or congestion and no history of suspicious allergies or similar rash in the past. Physical examination revealed a scattered erythematous fine papular rash on the trunk proximal arms, and the lower extremities. The parents had applied hydrocortisone cream to the rash prior to presentation to the physicians office. Event outcome was not reported. The reporter assessed the causality of the event to FluMist as unrelated.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Chills, Condition aggravated, Injection site erythema, Injection site mass, Injection site oedema
Clinical narrative: 5/18/06 Tele call to public health from parent, parent reporting swelling in left arm/hard/red. Had called MD last eve, gave Benadryl and Motrin per MD recommendation. PHN advised seek medical attention if parent felt increased in swelling. Parent took child to ER arm. Treated with 3 doses IV antibiotics discharged 5/19/06 AM. Home on oral antibiotics x5 days. 5-22-06 Parent report child doing well, swelling resolved. Medical records state vaccine reaction, chills. msv
Age: 16.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Dizziness, Headache, Oral intake reduced
Clinical narrative: Rec'd vaccine approx. 12:00 noon on 5/22/06. Remained at HD X 15 min. Approx. 13:30, began having mild to moderate H/A over forehead. Took ibuprofen last night. H/A relieved. Other associated symptoms were lightheadedness, weakness and loss of appetite. No longer lightheaded but weakness and loss of appetite persist. Mild symptoms remained.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: Rash, fever.
Age: 1.29
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: Rash, fever started 10 days after vaccination sent to Dermatologist, put on ATB.
Age: 47.0
Sex: F
Vaccine: FLU3, HEPA, IPV, TD, TYP
Symptoms: Abdominal pain, Disorientation, Headache, Memory impairment, Nausea
Clinical narrative: Spouse states 1 day after taking 1st oral typhoid capsule, she developed nausea, headache, abdominal cramps, forgetfulness, disorientation, wheezing. She continued capsules until complete.
Age: 47.0
Sex: F
Vaccine: FLU3, HEPA, IPV, TD, TYP
Symptoms: Wheezing
Clinical narrative: Spouse states 1 day after taking 1st oral typhoid capsule, she developed nausea, headache, abdominal cramps, forgetfulness, disorientation, wheezing. She continued capsules until complete.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Infection transmission via personal contact, Unevaluable event
Clinical narrative: Smallpox vaccine administered to roommate. Pt did not received vaccine but may have become secondarily infected on left forehead by room mate.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Infection, Injection site oedema, Injection site pain, Malaise
Clinical narrative: Had slight swelling, pain, tenderness x 5 days at site of injection. On 4/7/06 employee had fever of 101.6 with achiness, cough starting 28 hours after injection. Fever increased to 102.3 in evening of 4/7/06. Was still feeling sick on 4/10/06 when returned to work a clinic she works in. Dr there prescribed Zithromax which cleared up infection after a 5 day course. Infection lasted approx 1 1/2 to 2 weeks. No residual after effects.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia, Tenderness
Clinical narrative: Had slight swelling, pain, tenderness x 5 days at site of injection. On 4/7/06 employee had fever of 101.6 with achiness, cough starting 28 hours after injection. Fever increased to 102.3 in evening of 4/7/06. Was still feeling sick on 4/10/06 when returned to work a clinic she works in. Dr there prescribed Zithromax which cleared up infection after a 5 day course. Infection lasted approx 1 1/2 to 2 weeks. No residual after effects.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Diarrhoea, Difficulty in walking, Dizziness, Lymphadenopathy
Clinical narrative: 103 temp 3 days, dizziness, hard time walking, vomiting, diarrhea, glands swollen, achy. No breathing problems but said felt like someone was sitting on her chest.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: 103 temp 3 days, dizziness, hard time walking, vomiting, diarrhea, glands swollen, achy. No breathing problems but said felt like someone was sitting on her chest.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema
Clinical narrative: Local erythema 4X3cm diam, 3cm under injection site. C/O minor discomfort.
Age: 16.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema
Clinical narrative: 3 inch erythema around site.
Age: 29.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site hypersensitivity, Injection site oedema, Rash pustular
Clinical narrative: On day 10 Post vaccination, patient developed increasing redness and swelling at site with a pustule in the center! Streaking note to axilla, Levaquin 750 mg PO daily x 5 days.
Age: 25.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Chest pain, Dyspnoea, Feeling cold, Hyperhidrosis, Lymphadenopathy
Clinical narrative: Pt initial C/O sore throat and cold sweats on 5/16/06. Pt started vomiting on Tuesday evening through Wednesday. Pt went to ER on Wed night with c/o chest pain and labored breathing. Pt was diagnosed with muscle spasms in chest due to increased swelling of lymph nodes from smallpox vaccine.
Age: 25.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Muscle spasms, Pharyngolaryngeal pain, Vomiting
Clinical narrative: Pt initial C/O sore throat and cold sweats on 5/16/06. Pt started vomiting on Tuesday evening through Wednesday. Pt went to ER on Wed night with c/o chest pain and labored breathing. Pt was diagnosed with muscle spasms in chest due to increased swelling of lymph nodes from smallpox vaccine.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Contusion, Injection site erythema, Injection site reaction
Clinical narrative: Bruise at injection site DTaP, large area of erythema just distal to injection site later on day of immunization.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Face oedema, Pruritus, Tongue oedema, Urticaria
Clinical narrative: Tongue, lip swelling, head itching, Hives arms, chest legs.
Age: 1.05
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Erythema, Lethargy, Pyrexia, Rash
Clinical narrative: 7th Day after immunizations, temperature 100 - 100.5, light red bumps 5-10 on tummy and a few on face, slight lethargy. Light red bumps 30 on back, all of rash lasted only 4 days.
Age: 27.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Had tetanus shot after receiving stitches in left thumb. Area in left arm where shot administered has remained red, swollen, sore since day after.
Age: 28.0
Sex: F
Vaccine: HEP, HEPA, MMR
Symptoms: Arthralgia, Back pain, Feeling hot, Injection site pain, Muscle disorder
Clinical narrative: SX occurred 5/15/2006 right arm began hurting aching. 5/18/06 SX's right arm swollen, aching,  Pain right shoulder joint, right side neck swelling, back hurting, right tricep slight swollen, right side of chest, hot, swollen, rash light in color, confluent.
Age: 28.0
Sex: F
Vaccine: HEP, HEPA, MMR
Symptoms: Oedema, Pain, Rash, Shoulder pain
Clinical narrative: SX occurred 5/15/2006 right arm began hurting aching. 5/18/06 SX's right arm swollen, aching,  Pain right shoulder joint, right side neck swelling, back hurting, right tricep slight swollen, right side of chest, hot, swollen, rash light in color, confluent.
Age: 1.4
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Significant swelling and erythema at the injection site both proximal thighs worse on Lt thigh. No fever measured area of swelling and erythema Lt 4 inches Rt 2 inches.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site hypersensitivity, Injection site pain, Injection site warmth
Clinical narrative: 5/21/06 Local redness 6cm with warmth and pain x02 days with swelling T 36 to Emergency dept TX with PO antibiotics for cellulitis mild, right arm deltoid
Sex: M
Vaccine: PNC
Symptoms: Injection site rash, Skin ulcer
Clinical narrative: Pt got a rash and a quarter size lesion around the area of administration.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: L arm injection site, warm and swollen 6 1/2cm X 6 1/2cm.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Hives (urticarial)
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: Received immunizations 5/24/06. That evening had fever 101.4 (R). This AM 5/25/06 temp 103.5 (R). Mom gave Tylenol. Not wanting to eat or take formula this AM. He did take Pedialyte. Temp 100 (R) at 10:45 AM in office.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site pain, Screaming
Clinical narrative: Child crying inconsolably for 4 hours, post vaccination. Left upper thigh painful to touch and red. Mom applied cool compress to area and gave Tylenol at home. Child continued to cry and was instructed to return to office to be checked by MD. Examined by MD and Dx: hematoma on L thigh.
Age: 1.66
Sex: M
Vaccine: UNK
Symptoms: Dermatitis bullous
Clinical narrative: Rash/red base/blister in center, multiple lesions. Looks like varicella.
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: Dermatitis bullous, Injection site erythema, Injection site induration
Clinical narrative: R posterior upper arm (inj site) with 11 1/2 X 14cm raised erythema with 3 X 5cm central zone of more intense erythematous induration with linear blister. Local site reaction. No systemic reaction noted.
Age: 1.14
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Medication error
Clinical narrative: Patient given Pedivax with expiration date of 5/29/06.