chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Back pain, Influenza like illness, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: It has been rec'd that a pt with an insignificant medical history and no allergies who on 1/18/02 was vaccinated IM in the L arm with hepatitis B vaccine recombinant. Concomitant vaccinations included a rabies vaccine which was received on 1/18/02 and 1/25/02 in the L deltoid (lot#T0880). On 1/26/02 the pt experienced flu like illness ( chills and questionable fever), and muscle soreness which was mainly at the injection site. The pt's lymph node under her L arm swelled significantly and a lymph node on the L side of her neck became hard, swollen, and tender. The pt also experienced L sided neck tenderness. It was reported that all of the symptoms resolved in 3 days. At the time of this report, the pt also experienced pain in the upper part of her back when she turned left. At the time of this report, the pt had little residual pain with definite improvement. Unspecified medical attention was sought. Follow up and conflicting information has been rec'd from a RN who reported that on 1/18/02, the pt was vaccinated with the 1st dose of hepatitis B vaccine recombinant in the R deltoid (lot#641072-1164L exp:06/04/04). On 1/18/02 and on 1/25/02 the pt was vaccinated with the first and second doses of rabies vaccine (INOVAX RABIES VACCINE) in the L deltoid (lot#T0880). There were no other concomitant medications and no illness at time of vaccination. It was reported that on 1/26/02, the pt experienced flu like symptoms, chills, felt hot and cold, swollen and tender lymph nodes under the L arm and L side of neck times 3 days and the L side of her neck hurt. On 1/28/02 the pt's upper back by the top of her spine hurt. The nurse reported that the pt did not seek medical attention. The pt subsequently recovered from the flu like symptoms, chills, hot and cold feeling, swollen and tender lymph nodes under the L arm and L side of neck, L neck pain and back pain. It was also reported that there was no subsequent reaction on additional vaccinations with hepatitis B vaccine recombinant (details pertaining to the subsequent vaccination were not provided). No further info is expected.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Tenderness
Clinical narrative: It has been rec'd that a pt with an insignificant medical history and no allergies who on 1/18/02 was vaccinated IM in the L arm with hepatitis B vaccine recombinant. Concomitant vaccinations included a rabies vaccine which was received on 1/18/02 and 1/25/02 in the L deltoid (lot#T0880). On 1/26/02 the pt experienced flu like illness ( chills and questionable fever), and muscle soreness which was mainly at the injection site. The pt's lymph node under her L arm swelled significantly and a lymph node on the L side of her neck became hard, swollen, and tender. The pt also experienced L sided neck tenderness. It was reported that all of the symptoms resolved in 3 days. At the time of this report, the pt also experienced pain in the upper part of her back when she turned left. At the time of this report, the pt had little residual pain with definite improvement. Unspecified medical attention was sought. Follow up and conflicting information has been rec'd from a RN who reported that on 1/18/02, the pt was vaccinated with the 1st dose of hepatitis B vaccine recombinant in the R deltoid (lot#641072-1164L exp:06/04/04). On 1/18/02 and on 1/25/02 the pt was vaccinated with the first and second doses of rabies vaccine (INOVAX RABIES VACCINE) in the L deltoid (lot#T0880). There were no other concomitant medications and no illness at time of vaccination. It was reported that on 1/26/02, the pt experienced flu like symptoms, chills, felt hot and cold, swollen and tender lymph nodes under the L arm and L side of neck times 3 days and the L side of her neck hurt. On 1/28/02 the pt's upper back by the top of her spine hurt. The nurse reported that the pt did not seek medical attention. The pt subsequently recovered from the flu like symptoms, chills, hot and cold feeling, swollen and tender lymph nodes under the L arm and L side of neck, L neck pain and back pain. It was also reported that there was no subsequent reaction on additional vaccinations with hepatitis B vaccine recombinant (details pertaining to the subsequent vaccination were not provided). No further info is expected.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Hypersensitivity, Injection site hypersensitivity, Pruritus
Clinical narrative: Information was rec'd concerning a pt with seasonal allergies who on 9/10/01 in the PM and on 10/10/01 in the PM was vaccinated with the 1st (lot#636717/1592K) and 2nd (635178/0473K) dose of hepatitis B vaccine recombinant, both administered in the L deltoid. Concomitant therapy included Loratadine ( Claritin). There was no illness at the time of vaccination. Subsequently, after each dose the  pt developed itching at the injection site, described by the pt as occurring "inside the site". It was reported that the itching lasted 2 to 3 days and the pt recovered. It was noted that the pt opted "not to receive the 3rd vaccine". No further information is expected.
Age: 20.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Dizziness, Injection site erythema, Rash macular
Clinical narrative: Information has been received concerning a pt with no known drug allergies, who at the end of 9/01 was vaccinated IM with the 2nd dose of hepatitis B vaccine recombinant. (PI: 8/01). approx 30 minutes after receiving the vaccine, the pt experienced dizziness and weakness and developed a redness at the injection site and blotchy patches on his neck. One day later the reaction resolved. The pt experienced no side effects after the 1st injection.  No additional information is expected.
Age: 10.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Angiopathy, Arthritis, Autoimmune disorder, Collagen disorder, Rash
Clinical narrative: Information has been rec'd concerning a pt with attention deficit/hyperactivity disorder and enuresis who on 10/18/01 was vaccinated with his 1st dose of hepatitis B vaccine recombinant (lot#640334/0673L0. On 10/18/01 the pt was also vaccinated with MMR (MSD). Other concomitant therapy included clonazepam (Klonopin), methylphenidate HCl (Concerta) and desmopressin (DDAVP). In 10/01, after being vaccinated the pt experienced arthritis. On 12/26/01 the child was vaccinated with 2nd does of hepatitis B vaccine recombinant (lot#640005/0960L). In 12/01, after vaccination, the child developed an extensive rash that lasted for 2 weeks but continued with intermittent skin problems since then, The physician reported that the arthritis continued and he was being evaluated for collagen vascular disease or autoimmune disease in combination with the rash and arthritis.  Additional info has been requested.
Age: 10.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Skin disorder
Clinical narrative: Information has been rec'd concerning a pt with attention deficit/hyperactivity disorder and enuresis who on 10/18/01 was vaccinated with his 1st dose of hepatitis B vaccine recombinant (lot#640334/0673L0. On 10/18/01 the pt was also vaccinated with MMR (MSD). Other concomitant therapy included clonazepam (Klonopin), methylphenidate HCl (Concerta) and desmopressin (DDAVP). In 10/01, after being vaccinated the pt experienced arthritis. On 12/26/01 the child was vaccinated with 2nd does of hepatitis B vaccine recombinant (lot#640005/0960L). In 12/01, after vaccination, the child developed an extensive rash that lasted for 2 weeks but continued with intermittent skin problems since then, The physician reported that the arthritis continued and he was being evaluated for collagen vascular disease or autoimmune disease in combination with the rash and arthritis.  Additional info has been requested.
Sex: U
Vaccine: HEP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased
Clinical narrative: Information has been received from a health professional concerning a child who was vaccinated with hep B vaccine recombinant (manuf unk). It was reported that the child is involved in a formula study and therefore has multiple liver enzymes drawn. One month into the study, serum aspartate aminotransferase test (SGOT)=47; four months into the study, SGOT=50, serum alanine aminotransferase test (SGPT)=31; twelve months into the study and six hours after hep B vaccine (manuf unk), SGOP=427, SGPT=534, 15 months into the study, SGOT=5 units higher than nomral, normal for this lab=0-45. Upon internal review, increased SGOT and SGPT was determined to be other important medical events (OMIC). No further info is available.
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Nausea
Clinical narrative: Info has been rec'd concerning  a pt who was vaccinated with hepatitis B vaccine recombinant. Subsequently, 2 days after administration of their 1st dose of the hepatitis B vaccine recombinant, the pt experienced nausea and developed loose stools, the outcome of the pt's nausea and loose stools was unknown.  Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been rec'd concerning a pt who was vaccinated with hepatitis B vaccine recombinant. It was noted that the pt  serocoverted, but then had a waning titer. No other info was provided. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Injection site pain, Nausea
Clinical narrative: Information has been rec'd concerning a pt with no past medical history and no known allergies who on 4/4/02 was vaccinated with a 1st does of hepatitis B vaccine recombinant (lot#638671/0656L). Concomitant therapy that day included tuberculin purified protein derivative. The physician reported that the pt was probably given 3.0 instead of 1.0ml. It was noted by the physician that "it seemed like it took the nurse a long time to administer the shot". Later that day on 4/4/02, the pt had slight nausea and diarrhea and some arm soreness. The pt sought unspecified medical attention.  Follow up information indicated that the pt rec'd a 2nd dose of hepatitis B vaccine recombinant (lot #638671/0656L) (0.5ml) on 5/3/02 in the right arm. There were no concomitant medications and no illnesses at the time of vaccination. On 7/15/02 the pt developed arm pain, nausea and diarrhea. The pt recovered on 7/17/02. Additional information is not expected.
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Ear pain
Clinical narrative: Info has been received from a health prof'l concerning a female school employee who was vax'd w/Hep B vax recombinant. Subsequently, 1.5 hrs later the PT experienced lightheadedness and pressure in her ears. Add'l info. has been requested.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis, Liver function test abnormal
Clinical narrative: Info. has been received from a registered nurse from an employee health department concerning a 38 y.o. female financial analyst employee w/acne who was vax'd w/her first and 2nd dose of Hep B vax recombinant on 12/3/01 at 8 a.m. and 1/4/02 at 8:00, respectively. Concomitant therapy included one dose of MMRII on 1/11/02 and minocycline HCl (Dynacin), for treatment of her acne. The nurse reported that on an unknown date in 2002 the PT alleged that she had elevated liver enzymes and verbal reports of Lab results from the PT herself revealed elevated serum alanine aminotransferase of 123, elevated serum aspartate aminotransferase of 70, and elevated serum lactate dehydrogenase of 263. The nurse also reported that the "doctor felt she had hepatitis." It was not known why the PT had her liver enzymes tested but it was known that she has had the test done previously related to therapy w/minocycline HCl (Dynacin). The nurse further reported that there was no proof of the elevated liver enzymes at her facility, that the PT was no longer employed there, and that attempts to have follow-up have failed. The PT sought unspecified medical attention. Add'l info is not expected.
Sex: U
Vaccine: HEP
Symptoms: Arthralgia, Weight increased
Clinical narrative: Info has been received from a registered nurse concerning an adolescent PT who was vax'd w/Hep B vax recombinant. Subsequently the PT experienced weight gain and joint pain. Add'l info has been requested.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Injection site rash
Clinical narrative: Info has been received from a 27 y.o. female pharmacist who on 5/13/02 was vax'd w/a first 10 mcg dose of Hep B vax recombinant. On 5/13/02 the PT developed a rash around the inject site. On 5/15/02, it was reported that the PT still had the local inject site rash. PT stated she "thinks that she may have allergy to thimerosal, but not sure". Unspecified medical attention was sought. Add'l info has been requested.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Headache, Injection site oedema, Injection site pain, Myalgia
Clinical narrative: Info. has been received from a health prof'l concerning a 37 y.o. female w/a codeine allergy who in the 80's and in the 90's was vax'd w/Hep B vax recombinant series. There was no concomitant therapy. It was reported that the PT's titer was taken in the 80's and in the 90's and was found to be negative both times. In May 02 the PT received Hep B vax recombinant. On 5/15/02 the PT experienced pain and swelling at the inject site (left deltoid), nausea, vomiting, diarrhea, headache and generalized achiness. It was reported that the pain at the inject site lasted for more than 2 days. Add'l info has been requested.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Vomiting
Clinical narrative: Info. has been received from a health prof'l concerning a 37 y.o. female w/a codeine allergy who in the 80's and in the 90's was vax'd w/Hep B vax recombinant series. There was no concomitant therapy. It was reported that the PT's titer was taken in the 80's and in the 90's and was found to be negative both times. In May 02 the PT received Hep B vax recombinant. On 5/15/02 the PT experienced pain and swelling at the inject site (left deltoid), nausea, vomiting, diarrhea, headache and generalized achiness. It was reported that the pain at the inject site lasted for more than 2 days. Add'l info has been requested.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis, Laboratory test abnormal
Clinical narrative: Info has been received from a physician concerning a 19 year old female pt, who in approx. 1999 was vaccinated with the Hep-B series. In approx. 2002, the pt "tested positive core antibody". Unspecified medical attention was sought. Additional info has been requested.
Sex: F
Vaccine: HEP
Symptoms: Injection site mass, Oedema, Pain, Vasodilation procedure
Clinical narrative: Info. has been received from a female PT who on approx 5/22/02 was vax'd w/a "booster dose' of Hep B vax recombinant. The PT reported that she received the Hep B vax recombinant series in 91, respectively. The PT also reported that post-vax, her arm had a "knot", was painful, swollen, and warm to touch. The outcome of the PT's events was unknown. It was unknown if the PT sought medical attention. No further info. is available.
Age: 42.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Blister, Myalgia
Clinical narrative: Info has been received from a physician concerning a 42 year old male with no known drug allergies who on 5/31/02 was vaccinated with the 3rd dose of Hep-B. On 6/3/02, the pt presented with rash, blisters, arthralgias and muscle pains. The outcome of the pt's rash, blisters, arthralgias and muscle pains was unknown. It was reported that the pt sought unspecified medical attention. It was also reported that the pt was subsequently being referred to an allergist. Additional info has been requested.
Age: 1.5
Sex: M
Vaccine: HBHEPB, HEP
Symptoms: Speech disorder
Clinical narrative: Info has been received from a mother concerning her 18 month old son who was vaccinated with Hep-B. Concomitant therapy included Haemophilus B conjugate vaccine (+) Hep-B vaccine recombinant (yeast). In approx. June, 2002, the mother reported that her son had not started to speak yet. Additional info has been requested.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Panic reaction
Clinical narrative: Info has been received on 6/6/02 from a nurse practitioner concerning a 23 y.o. female who was vax'd w/a 1st and 2nd dose of Hep B vax recombinant. Subsequently, a few hrs after each vax, the PT had panic attacks. It was reported that "this lasted for a short period of a few hrs." The PT was treated w/clonazepam (Klonopin) and paroxetine HCl (Paxil), "after the panic attacks started." The PT sought unspecified medical attention. Add'l info has been requested.
Age: 73.0
Sex: M
Vaccine: HEP
Symptoms: Aspartate aminotransferase increased
Clinical narrative: Info has been received on 6/6/02 from an MD concerning a 73 y.o. male w/diabetes and a history of cardiac heart failure and arrhythmias who was vax'd w/the first and 2nd doses of Hep B vax recombinant. Concomitant therapy included glipizide (Glucotrol XL), insulin human (Humulin R), enalapril, furosemide, amiodarone hydrochloride (Cordarone), carvedilol, multivitamins, and ferrous SO4 (Feosol). The PT's asparate transamine and alanine transaminase levels have been increasing since the 2nd dose. The PT sought unspec'd medical attention. Add'l info has been requested.
Sex: F
Vaccine: HEP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Drug ineffective
Clinical narrative: Info has been received on 6/11/02 from a registered nurse w/a history of endometriosis and NDKA who "11 yrs ago" received a series of Hep B vax recombinant. Subsequently the PT had a titer that was negative. On 3/5/02 the PT was vax'd w/a booster dose of Hep B vax recombinant. Concomitant therapy on 3/5/02 included tramadol HCl (Ultram), valdecoxib (Bextra) and carisodropol (Soma). The nurse had a titer in Apr. 02 that indicated the presence of antibodies. The PT also has labs drawn on 5/29/02 and had an "elevated SGOT 52 (nl 1-50) and SGPT 76 (nl 1-50)." It was noted that the PT also received a dose of MMRII at the end of March 02, "because of a negative rubella titer." Add'l info has been requested.
Sex: F
Vaccine: HEP
Symptoms: Back pain, Difficulty in walking, Musculoskeletal stiffness, Pyrexia, Systemic lupus erythematosus
Clinical narrative: Information was rec'd concerning a pt who on 5/1/01 was vaccinated with a booster dose of hepatitis B vaccine recombinant. A few weeks after the vaccination, she experienced "Lupus like symptoms" which included fever, stiffness, extreme back pain and pain walking. There was no swelling. The pt did not seek medical attention. No further information is available.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Injection site pain, Laboratory test abnormal, Myalgia, Overdose
Clinical narrative: Information has been received from a doctor of dental surgery concerning a white 32 year old dental assistant, gravida III, female with a codeine allergy who on 6/18/02, was "inadvertently" vaccinated with 3ml of hep B vaccine recombinant(638671/0656L). There was no concomitant medication. Follow-up info was received from the doctor of dental surgery. There was no illness at the time of the vaccination. On 6/18/02, the pt developed a slight diarrhea for one day, experienced muscle soreness at the injection site for three days and slight muscle soreness in the trapezius (bilaterally) for three days. The pt recovered three days after administration of the vaccination. The doctor of dental surgery reported that the pt did not "really require medical intervention per the symptoms, but the doctor of dental medicine believed that it was necessary to follow up with a physician visit. On 7/3/02, the pt's serum hep B surface antibody screen was >150.0mIU/mL. It was reported that there was "no need for further HBV shots. Started series a few years back and looks like she is immune." Additional follow up info was received from the doctor of dental surgery who reported that his office was "scared" over this event of overdose. He reported that he "could not find info int he product circular." Therefore, the office referred the pt to her medical doctor for monitoring. The doctor of dental surgery reported that the pt did not require any intervention and recovered from the event. The doctor of dental surgery suggested that hep B vaccine recombinant not be packaged in multidose vials. The administering doctor of dental medicine had given the hep B vaccine recombinant in the past from one-dose vials. When administering this dose of hep B vaccine recombinant, she did not realize that it was a multidose vial and drew up the entire contents and administered the vaccination. The reporter indicated that the pt required medical intervention to prevent a serious medical event (OMIC). No additional info is available.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Dyspnoea, Lethargy, Nervousness, Paraesthesia
Clinical narrative: Info. has been received from an MD concerning a 39 y.o. female dental office secretary who was vax'd w/a "series" of Hep B vax recombinant in the "early" 80's. Subsequently, the PT had a "titer" done and had "no titer". Subsequently, the PT was vax'd w/the first dose of her 2nd series of Hep B vax recombinant, and experienced SOB, nervousness, lethargy and tingling from the top of her head to her knees. Add'l info. has been requested.
Age: 51.0
Sex: F
Vaccine: HEP, HEPA, TD, TYP
Symptoms: Oedema, Tongue oedema
Clinical narrative: Info has been received from a registered nurse concerning a 51 y.o. female w/allergies to PCN, sulfa, ibuprofen (Motrin) and codeine and a history of anaphylaxis related to ibuprofen who on 5/23/02 was vax'd w/Hep B vax recombinant. Concomitant suspect therapy, received during the same visit, included typhoid vax, Hep A vax, diphtheria toxoid/tetanus toxoid and yellow fever virus vax live. Other concomitant therapy included "clorpheniramine", estrogens conjugated (+) medroxyprogesterone acetate (Prempro), vitamin E, ascorbic acid, folic acid, calcium (unspec'd) (+) vitamin D (unspec'd), cyanocobalamin and multivitamins (unspec'd). On 5/23/02, 2 hrs post vax's, the PT developed a thick tongue and itching of the throat and tongue. Subsequently, the PT was treated w/prednisone and an antihistamine (unspec'd). The PT did seem medical attention. Add'l info has been requested.
Age: 37.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Injection site erythema, Injection site mass, Pruritus
Clinical narrative: Info. has been received from a registered nurse concerning a 37 y.o. male admissions clerk w/epilepsy w/NKA, who on unspecified dates in 2002 was vax'd w/a 3 dose series of Hep B vax recombinant. Concomitant therapy included phenytoin (Dilantin) "300 mg then 200 mg 4 hrs after - daily." Subsequently, the PT's titers were negative. On 6/7/02 the PT was vax'd IM in the left deltoid w/a 4th dose of Hep B vax recombinant. Subsequently, the PT developed a quarter sized reddened induration that itches at the inject site. The PT continued to have this at the time of this report, which was noted to be several wks later. Follow-up info received from the registered nurse indicated that on 6/11/02 the PT developed a 42 mm x 35 mm raised reddened area at the inject site. The PT also c/o'd of itching, "which although is resolving still itches." The PT's outcome was reported as not recovered. Add'l info is not expected.
Age: 0.5
Sex: F
Vaccine: HEP
Symptoms: Anorexia, Crying
Clinical narrative: Info. has been received from an MD concerning a 6-mt old female who was vax'd w/the 2nd dose of Hep B vax recombinant. Subsequently, the PT experienced screaming and would not eat for 3 days. Unspec'd medical attention was sought. Add'l info has been requested.
Sex: U
Vaccine: HEP
Symptoms: Arthropathy
Clinical narrative: Info has been received on 7/5/02 from a pharmacist on behalf of an MD concerning a PT who was vax'd w/a 3 dose series of Hep B vax recombinant. Subsequently, 3 wks later, the PT developed "bilateral painless knee effusions." It was reported to be unknown if the PT was an adult or child, however, the PT reportedly was seeing an adult orthopedist. The PT sought unspec'd medical attention. Add'l info has been requested.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective, Hepatitis, Hepatitis B, Hepatitis B surface antigen positive, No therapeutic response
Clinical narrative: Info has been received from an internet publication concerning a surgeon who in 85 was vax'd w/Hep B vax recombinant. It was reported that the surgeon was infected w/Hep B and may have infected at least 28 of his PTs. More than 1,500 PT's who the surgeon treated btwn 1995 and Feb. 99 were tested, and researchers determined that the MD had passed the virus on to 8 PT's, and likely infected 2 others, and may have infected 18 more. It was noted that the MD apparently did not respond to the immunization and was routinely exposed to the blood of PTs while working under primitive conditions. It was not reported if the surgeon sought medical attention. Information was also received in a published abstract (Undiscovered hepatitis B transmission from an hepatitis B E antigen positive surgeon to his patients over a four-year period). Three cases of acute hepatitis B were reported at a regional health service, all patient were operated on at hospital A by the same general surgeon. The surgeon (X) was found to be HbaAg positive with a viral load of >5x10^g copies/ml. A retrospective cohort study was conducted on 1562 patients on whom surgeon X had operated from June 1995 through February 1999. Moreover, a case control study was carried out to study risk factors for HBV transmission. Surgeon X transmitted HBV to 29 patients (1.9%), of whom 2 remained HBV carriers. In addition, one case of secondary transmission was identified, in which the patient died from fulminant hepatitis B infection. DNA sequencies obtained from surgeon X were 100% identical to sequences in 7 of the 29 cases and in the case of secondary transmission. Surgeon X was a non-responder after HBV vaccination (manufacturer unknown) and appeared to be infected for more than ten years. At least 11 patients were infected during "low risk" procedures. Transmission from surgeon to patient can occur without discovery for along period of time. Prevention required a more stringent policy for the vaccination and testing of surgeons. It may require revision of policies allowing surgeons to perform "non-exposure prone" procedures, since these are not without risk of HBV transmission. No further information is available. This is a consolidation of two reports concerning the same patient. The primary source has changed from a domestic source to a foreign source. Therefore, this report no longer meets criteria for submission.
Sex: U
Vaccine: HEP
Symptoms: Primary transmission
Clinical narrative: Info has been received from an internet publication concerning a surgeon who in 85 was vax'd w/Hep B vax recombinant. It was reported that the surgeon was infected w/Hep B and may have infected at least 28 of his PTs. More than 1,500 PT's who the surgeon treated btwn 1995 and Feb. 99 were tested, and researchers determined that the MD had passed the virus on to 8 PT's, and likely infected 2 others, and may have infected 18 more. It was noted that the MD apparently did not respond to the immunization and was routinely exposed to the blood of PTs while working under primitive conditions. It was not reported if the surgeon sought medical attention. Information was also received in a published abstract (Undiscovered hepatitis B transmission from an hepatitis B E antigen positive surgeon to his patients over a four-year period). Three cases of acute hepatitis B were reported at a regional health service, all patient were operated on at hospital A by the same general surgeon. The surgeon (X) was found to be HbaAg positive with a viral load of >5x10^g copies/ml. A retrospective cohort study was conducted on 1562 patients on whom surgeon X had operated from June 1995 through February 1999. Moreover, a case control study was carried out to study risk factors for HBV transmission. Surgeon X transmitted HBV to 29 patients (1.9%), of whom 2 remained HBV carriers. In addition, one case of secondary transmission was identified, in which the patient died from fulminant hepatitis B infection. DNA sequencies obtained from surgeon X were 100% identical to sequences in 7 of the 29 cases and in the case of secondary transmission. Surgeon X was a non-responder after HBV vaccination (manufacturer unknown) and appeared to be infected for more than ten years. At least 11 patients were infected during "low risk" procedures. Transmission from surgeon to patient can occur without discovery for along period of time. Prevention required a more stringent policy for the vaccination and testing of surgeons. It may require revision of policies allowing surgeons to perform "non-exposure prone" procedures, since these are not without risk of HBV transmission. No further information is available. This is a consolidation of two reports concerning the same patient. The primary source has changed from a domestic source to a foreign source. Therefore, this report no longer meets criteria for submission.
Age: 10.0
Sex: F
Vaccine: HEP
Symptoms: Blister, Injection site erythema, Rash macular
Clinical narrative: Information has been received from a medical assistant concerning a 10 year old "healthy" female with no past medical history who on 7/2/02 was vaccinated with the second dose of hep B vaccine. There were no concomitant medications. On 7/14/02 the pt developed blisters posterior to the site, on the inner elbow and at the top of the scapula. On 7/18/02 the site was blotchy and red and the pt was afebrile. The reporter stated that there were no adverse reactions noted from the first dose of hep B vaccine recombinant. The pt was treated with Claritin. The pt sought unspecified medical attention. Follow-up info from the medical assistant revealed that the pt was vaccinated at a health department and stated "everything is fine." No further info is available.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Headache, Influenza like illness, Pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 38 year old female teacher with no part medical history and no known drug allergies who was vaccinated on the morning of 4/25/02 IM in the left deltoid with a second dose of hep B vaccine recombinant. Concomitant therapyincluded diazepam. There was no illness at the time of vaccination. The pt "woke up the next morning and felt like she had the flu." It was reported that the symptoms lasted for 24 to 36 hrs then "went away without treatment." Follow-up info received from the nurse practitioner indicated that on 4/25/02, in the evening, the pt developed "flu like symptoms" which included headache, chills and body aches. The pt recovered on 4/27/02. Additional info is not expected.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Injection site urticaria
Clinical narrative: Information has been received from a licensed practical nurse concerning a 32 year old female whon on 6/5/02 was vaccinated with her second dose of hep B vaccine recombinant. On 6/5/02 the pt received the vaccine intradermaly into the left forearm developing a 4mm wheal at injection site that has not resolved. Unspecified medical attention was sought. Additional info has been requested.
Age: 53.0
Sex: M
Vaccine: HEP
Symptoms: Musculoskeletal stiffness, Myalgia, Nasopharyngitis, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 53 year old male who on 4/11/02 was vaccinated with hep B vaccine recombinant 10mcg, first dose (641448/1497L). On approximately 4/11/02 the pt developed cold symptoms for the duration of 2-3 days and experienced muscle achiness for the duration of 15 days. On 5/16/02 the pt was administered his second dose of hep B vaccine recombinant10mcg, (642483/0008M). In approximately May 2002, the pt experienced right arm myalgia "which went to the neck and legs." The pt also stated that the muscles under the knees were very stiff. The pt visited his primary physician who recommended ibuprofen and acetaminophen. In approximately May 2002 the pt had a fever of 99-100 degrees F for the duration of 'about one month." The pt's temperature would rise in the middle of the day. The reporter stated that the pt would "take medication in the morning but no additional medication during the day." The pt sought medical attention. Additional info has been requested.
Sex: F
Vaccine: HEP
Symptoms: Injection site induration, Medication error
Clinical narrative: Information has been received from a registered nurse concerning a female pt who on 7/26/02 was vaccinated with SC in the left forearm with her fourth dose of hep B vaccine recombinant. The pt developed "a small hard spot" at the injection site. The registered nurse also reported that on 7/26/02 the pt was supposed to be given a vaccine other than hep B vaccine recombinant, but the nurse inadvertently "grabbed the wrong vial." The registered nurse reported that the pt was seen by an MD who prescribed Allegra, BID to treat the reaction. She noted that the pt recovered after approximately three weeks and that the area is now "normal." No additional info is available at this time.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Chills, Influenza like illness, Joint swelling, Musculoskeletal stiffness
Clinical narrative: Information has been received from a health professional concerning an approximately 39 year old white female with pcn allergy who "about five years ago," in approximately 1997 was vaccinated with one dose of hep B vaccine recombinant. Following vaccination, the pt experienced generalized illness with aching and chills. The outcome of these events was not reported. She did not complete the dose series. The pt subsequently developed arthralgia, swelling and effusion of the right knee, flu-like symptoms, hives, neck stiffness, and rash following vaccination with MMR II (WAES0205USA00787). Follow up info received, from a registered nurse, on 9/6/02 indicated that she did not know any of the details of the adverse events following vaccination with hep B vaccine recombinant. She stated that it occurred five years ago and that the pt was a new employee as of March 2002. She further stated that there was no documentation of this vaccination or the events in the employee's chart. Unspecified medical attention was sought. No further info is available.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Rash, Urticaria
Clinical narrative: Information has been received from a health professional concerning an approximately 39 year old white female with pcn allergy who "about five years ago," in approximately 1997 was vaccinated with one dose of hep B vaccine recombinant. Following vaccination, the pt experienced generalized illness with aching and chills. The outcome of these events was not reported. She did not complete the dose series. The pt subsequently developed arthralgia, swelling and effusion of the right knee, flu-like symptoms, hives, neck stiffness, and rash following vaccination with MMR II (WAES0205USA00787). Follow up info received, from a registered nurse, on 9/6/02 indicated that she did not know any of the details of the adverse events following vaccination with hep B vaccine recombinant. She stated that it occurred five years ago and that the pt was a new employee as of March 2002. She further stated that there was no documentation of this vaccination or the events in the employee's chart. Unspecified medical attention was sought. No further info is available.
Sex: M
Vaccine: HEP
Symptoms: Facial palsy
Clinical narrative: Information has been received from a physician concerning a male child who was vaccinated with a dose of hep B vaccine recombinant. Subsequently, four days after vaccination, the pt developed symptoms of bell's palsy and nausea. Unspecified medical attention was sought. Additional info has been requested.
Sex: F
Vaccine: HEP
Symptoms: Eye irritation
Clinical narrative: Information has been received form a female physician who on 7/30/02 had splashed herself in the eye with hep B vaccine recombinant 10mcg (642246/0032M) while trying to draw up a dose. She believed that she was exposed to just a few drops. At the time of this report on 7/30/02, her eye felt irritated. She sought unspecified medical attention.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Vitiligo
Clinical narrative: Information has been received from a 57 year old black female with a pcn allergy who on 2/22/02 was vaccinated with the first dose of hep B vaccine recombinant. Concomitant therapy included Procardia, and amiloride hydrochloride-HCTZ. In February 2002, a few days after vaccination, the pt noticed two skin discoloration on her thigh (later reported as vitiligo). On 4/13/02, the pt was vaccinated with a second dose of hep B vaccine. In April 2002 after vaccination, the pt experienced some sort of skin reaction all over her chest and arms and hips which she called discoloration of the skin (later reported as vitiligo). The pt was treated with triamcinolone. The pt's outcome was unknown. Follow-up reports the vitiliog "seemed to be triggered by the vaccien according to the pt and history of time sequence." On 9/17/02 the physician reported that the pt had not returned for follow up and no further info was available at this time. Additional info has been requested.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash
Clinical narrative: Information has been received from a registered nurse concerning a female in her early 40's a penicillin allergy and no relevant medical history who on 7/10/02 was vaccinated with a first dose of hep B vaccine recombinant (641694/1534L). There was no concomitant medication. On 7/12/02, the pt developed an intense itching under her skin all over her body and "bumps" on her arms. The pt sought unspecified medical attention. The pt's symptoms lasted for about 2 days. No additional info is expected.
Age: 52.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Arthritis, Myalgia, Pain, Rheumatoid factor
Clinical narrative: Information has been received from a physician concerning a 52 year old male with "unremarkable" past medical history and no allergies, who in early April 2002 and early Mary 2002 was vaccinated with a first and second dose of hep B vaccine recombinant. There was no concomitant medication. One week after the first vaccination, in April 2002, the pt developed muscle pain. Approximately one month after the second vaccination, in June 2002, the pt reported that the pain and aches became more severe. The physician described the pt's pain as musculo-skeletal pain, rheumatoid arthritis like symptoms. A rheumatoid factor level done on 8/1/02 was 15.9. Unspecified medical attention was sought. Additional info has been requested.
Sex: U
Vaccine: HEP
Symptoms: Injection site reaction
Clinical narrative: Info has been received from a pharmacist who received a report from an MD concerning a PT who was vax'd in the buttock w/a dose of Hep B vax recombinant and not the buttock has an indentation in it, "just like laying an egg." Unspecified medical attention was sought. Add'l info has been requested.
Age: 30.0
Sex: F
Vaccine: DT
Symptoms: Asthenia, Pyrexia, Somnolence
Clinical narrative: Info has been received from a registered nurse concerning a 30 y.o. female w/no known allergies who on 11/5/01, was vax'd w/her first dose of Hep B vax recombinant. Concomitant therapy included multivitamins (unspec'd). On 11/5/01, post vax, the PT reported feeling tired, feverish, and somnolent. These Sx's continued for approx 3 wks. On 8/5/02, the PT was vax'd w/her 2nd dose of Hep B vax recombinant. On 8/5/02, post vax, the registered nurse reported that the PT experienced the same "constellation" of Sx's. As of 8/14/02, the registered nurse reported that the PT had not been treated w/any interventions. Add'l info has been requested.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Rash erythematous
Clinical narrative: Info. has been received from a nurse practitioner concerning a 37 y.o. HIV positive female w/no known allergies, who on 8/13/02 was vax'd w/the 2nd dose of a 2nd series of Hep B vax recombinant. Concomitant therapy included sulfamethoxazole / trimethoprim (Bactrim), tenofovir disoproxil fumarate (Viread), lamivudine (Epivir), efavirenz (Sustiva), dicyclomine HCl (Bentyl) and fexofenadine (Allegra). On 8/14/02 the PT developed a red rash distal to the inject site. Unspecified medical attention was sought. At the time of this report, the outcome of the rash was unknown. Add'l info has been requested.
Sex: M
Vaccine: HEP
Symptoms: Confusional state, Hypertonia
Clinical narrative: Info has been received from a consumer and his wife concerning their son's pediatrician, ad adult male, who "recently" in approx 2002 was vax'd w/a dose of Hep B vax recombinant. It was reported that he experienced "bad reactions to the shot". The reporter indicated that the PT told him about the reactions, but did not go into detail. It was reported that it "sounded like" his muscles became rigid. He was also "bewildered and thought he might have a brain tumor until he realized his Sx's were a reaction to the shots." No add'l info was provided. The consumer reported this episode upon providing follow-up info, reporting his son who developed "severe adverse effects" following vax w/Hep B vax recombinant. Add'l info is not expected.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Anorexia, Asthenia, Depression, Dizziness, Malaise
Clinical narrative: Info has been received from a consumer concerning her 12 y.o. daughter w/no known medical history who was vax'd w/a first, 2nd and 3rd dose of Hep B vax recombinant in Jan 01, Apr 01, and Nov 01, respectively. There was no concomitant medication. W/in 2 mts of vax, w/the first dose the PT experienced weakness, loss of appetite, weight loss, depression and dizziness. The PT again experienced these Sx's w/2 mts of the 2nd dose of the vax. Subsequently, w/in 2 mts of the 3rd dose, the PT again experienced weakness, loss of appetite, weight loss, depression and dizziness. As of 8/19/02, the PT's mother reported that her daughter, "has continued to experience these Sx's since the last vax, and has been consistently ill since March". Unspecified medical attention has been sought. Add'l info has been requested.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Weight decreased
Clinical narrative: Info has been received from a consumer concerning her 12 y.o. daughter w/no known medical history who was vax'd w/a first, 2nd and 3rd dose of Hep B vax recombinant in Jan 01, Apr 01, and Nov 01, respectively. There was no concomitant medication. W/in 2 mts of vax, w/the first dose the PT experienced weakness, loss of appetite, weight loss, depression and dizziness. The PT again experienced these Sx's w/2 mts of the 2nd dose of the vax. Subsequently, w/in 2 mts of the 3rd dose, the PT again experienced weakness, loss of appetite, weight loss, depression and dizziness. As of 8/19/02, the PT's mother reported that her daughter, "has continued to experience these Sx's since the last vax, and has been consistently ill since March". Unspecified medical attention has been sought. Add'l info has been requested.
Age: 5.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Info has been received from a mother concerning her 5 y.o. daughter who on 3/19/97, was vax'd w/a first dose of Hep B vax recombinant. W/in 24 hrs the PT developed dollar bill size hives on her trunk and legs, but no  other Sx's. Subsequently, the PT recovered from the dollar bill size hives. The mother stated that the family moved and their new family practitioner would like to continue the child on therapy w/Hep B vax recombinant. The PT's mother stated that she is going to discuss this w/an allergist. Follow-up info received from the office manager at the PT's new practice stated that they have no add'l info regarding the PT's experience. Add'l info is not expected.
Age: 8.0
Sex: M
Vaccine: HEP
Symptoms: Injection site erythema, Injection site oedema, Injection site rash, Injection site reaction
Clinical narrative: Info has been received from a registered nurse concerning an 8 y.o. male who on 8/5/02 was vax'd w/a first dose of Hep B vax recombinant. On 9/5/02, the PT was seen in the MD's office for a 2nd dose of Hep B vax recombinant, when a 15 mm round, red, raised, scaly area at the inject site was noted. The perimeter of the area had blister-like bumps, and the area was itchy. It was reported to look "more like a wound than a rash". The reaction was reported to have occurred "sometime after administration" and was still present at the office visit. Unspecified medical attention was sought. Add'l info has been requested.
Age: 62.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Hepatitis
Clinical narrative: This report was received from manufacturer for Hep B vax and was assigned a report number. Info has been received concerning an approx 62 y.o. male w/an unknown prior medical history who in approx 1989 was vax'd w/a full series of Hep B vax recombinant. It is unknown if the PT received concomitant medications. Subsequently, it was reported on 9/11/02, that the PT "gave blood recently and was told he had Hep B". It was reported that no medical attention was required. Add'l info has been requested. This was originally reported by a healthcare prof'l.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Gait disturbance, Pain
Clinical narrative: Info has been received from a consumer concerning a 12 y.o. female PT w/no known drug allergies, who in July 02 was vax'd w/Hep B vax recombinant. There was no concomitant medication. Subsequently, 2 days post vax w/Hep B vax recombinant the PT developed leg pain and could not walk on her leg.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Myalgia, Pyrexia, Vomiting
Clinical narrative: Info has been received from a nurse concerning a 12 y.o. female child w/unknown allergies and medical history who on unspecified dates, was vax'd w/doses of Hep B vax recombinant. Subsequently the PT developed vomiting and diarrhea after her 2nd dose of Hep B vax, and fever of 102 deg F w/achiness after her 3rd dose. Unspecified medical attention was sought. Add'l info has been requested.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Chest pain, Pain
Clinical narrative: Info has been received from a medical assistant concerning a 12 y.o. female who on 4/19/02 and 5/21/02 was vax'd w/Hep B vax recombinant. Concomitant therapy included salmeterol xinafoate (Serevent). Subsequently the PT experienced a painful arm after her first dose and a painful chest and arm after her 2nd dose. A physical exam revealed no redness. The PT sought medical attention. Add'l info has been requested.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Hypertonia, Injection site oedema, Paraesthesia, Vasodilation procedure
Clinical narrative: Info has been received from an MD concerning a 12 y.o. female who on 9/18/01 was vax'd w/a first dose of Hep B vax recombinant. Subsequently, 10 mins post vax, the PT developed numbness and stiffness in her arms and legs as well as fatigue. According to the reporter, the inject site was mildly swollen and warm. Medical attention was sought and the PT was given ibuprofen (Motrin). On 9/20/02, the PT was reported as doing "better today". Add'l info has been requested.
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Info has been received from a DDS concerning a female who was vax'd w/Hep B vax recombinant. The PT received the 1st dose of Hep B vax recombinant w/out any prob's. The PT received the 2nd dose (date UNK) and w/in 24 hrs she developed a rash on the one leg. The PT was treated w/diphenhydramine hydrochloride (Benadryl) and the rash "was gone the next day". Unspecified medical attention was sought. Add'l info has been requested.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Headache, Rash
Clinical narrative: Info. has been received from a registered nurse concerning an approx 11 y.o. male w/no medical history and NKDA, who on 8/20/02 was vax'd w/a 1st dose of Hep B vax recombinant. There was no concomitant medication. Subsequently, the PT developed a severe headache for 3 days and a rash on his back, chest, and arms. Unspecified medical attention was sought. No further info. is available.