chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: HEP
Symptoms: Chest pain, Dysphagia, Laboratory test abnormal, Lymphadenopathy, Lymphopenia
Clinical narrative: A physician reported the occurrence of chest pain in a 62 year old male who was vaccinated with hep B vaccine recombinant for prophylaxis. The subject's relevant medical history included polycystic kidney disease treated with hemodialysis. Concurrent medications were unknown. In March 2001, April 2001, May 2001 and 8/31/01, the subject received injections of Engerix B. On 9/1/01, he experienced chest pain, a feeling of fullness in neck, and pain on swallowing. He was seen in the ER. X-rays of the neck and CT showed "lymphadenopathy in the neck area only." At that time, he had no indication of viral infection. Complete blood count revealed lymphopenia with a normal white blood cell count. On 11/8/01, it was determined that the subject had not seroconverted as a result of receiving Engerix B. CT performed on 11/9/01 indicated "no lymphadenopathy." The chest pain, feeling of fullness, and painful swallowing resolved on an unspecified date. The subject felt that the events were due to Engerix B administration. The reporting physician considered the events to be possibly related to Engerix B administration. The subject refused additional Engerix B booster as indicated for hemodialysis patients.
Age: 62.0
Sex: M
Vaccine: HEP
Symptoms: Pain
Clinical narrative: A physician reported the occurrence of chest pain in a 62 year old male who was vaccinated with hep B vaccine recombinant for prophylaxis. The subject's relevant medical history included polycystic kidney disease treated with hemodialysis. Concurrent medications were unknown. In March 2001, April 2001, May 2001 and 8/31/01, the subject received injections of Engerix B. On 9/1/01, he experienced chest pain, a feeling of fullness in neck, and pain on swallowing. He was seen in the ER. X-rays of the neck and CT showed "lymphadenopathy in the neck area only." At that time, he had no indication of viral infection. Complete blood count revealed lymphopenia with a normal white blood cell count. On 11/8/01, it was determined that the subject had not seroconverted as a result of receiving Engerix B. CT performed on 11/9/01 indicated "no lymphadenopathy." The chest pain, feeling of fullness, and painful swallowing resolved on an unspecified date. The subject felt that the events were due to Engerix B administration. The reporting physician considered the events to be possibly related to Engerix B administration. The subject refused additional Engerix B booster as indicated for hemodialysis patients.
Age: 53.0
Sex: F
Vaccine: HEP, TTOX
Symptoms: Injection site pain, Laboratory test abnormal, Shoulder pain
Clinical narrative: A nurse described the occurrence of injection site pain in a 53 year old female who was vaccinated with hep B vaccine recombinant (Engerix B) for prophylaxis. The subject's medical history and concurrent medications were not reported. The subject experienced no adverse events following previous immunizations. The subject received the "entire series" of Engerix B injections in 1988. On 2/10/03, her "hep B titer" was "less than 2.0.: On 2/25/03, the subject received her fourth injection of Engerix B (5371A4) injected into the right arm. At that time, she was experiencing right shoulder pain. She also received an injection of tetanus toxoid injected into the left deltoid. On 2/27/03, the subject experienced injection site pain. She telephoned the vaccine provider to report the event. The reporting nurse considered the event to be possibly related to Engerix B administration, or to the right shoulder pain that was present at the time of immunization. As of 3/25/03, the outcome of the event was unknown.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Malaise, Nausea
Clinical narrative: A nurse reported the occurrence of dizziness in a 35-year-old female who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. The had no known drug allergies. The medical history, concurrent conditions and concurrent medications were not reported. On 11/24/2002, the pt received her 1st injection of Engerix-B. Approx one hour post-immunization, she experienced dizziness and nausea and went home from work for the day. She reported that she generally felt sick. The reporting nurse considered the events to be possibly related to Engerix-B administration. The events resolved on 11/24/2002. The immunization series was delayed.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: A nurse reported that a 33-year-old female did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series. The pt's medical history, concurrent conditions and concurrent medications were unknown. The pt received injections of Engerix-B on 08/04/1998 (lot # not provided), 03/25/2002 (lot ENG5257A4) and 05/20/2002 (lot ENG5257A4). The vaccine was not administered according to the recommended schedule of 0, 1, and 6 months. Six months after the 3rd injection of Engerix-B, on 11/20/2002, an unspecified titer was "less than 2". In December 2002, the pt received her 4th injection of Engerix-B. Comment: The reporter indicated that 4 additional subjects did not achieve protective antibody titers following immunization with Engerix-B. Please see reports A0400568A, A0400569A, A0400570A, and A0400571A.
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia
Clinical narrative: A physician reported the occurrence of numbness in the arms and legs of a female of unspecified age who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. The pt's medical history and concurrent conditions were not specified. Concurrent medications included methadone hydrochloride. On an unspecified date, the pt received her 1st injection of Engerix-B. One week post-immunization, the pt began to experience "numbness in arms and legs at rest." As of 03/05/2003, the physician reported that the numbness had improved.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: A nurse reported that a 43-year-old female had a decreased response to the hepatitis B vaccine recombinant (Engerix-B) immunization series. The pt's medical history, concurrent conditions and concurrent medications were unknown. The pt received injections of Engerix-B on 06/30/1992, 07/30/1992 and 01/30/1993. On 01/29/2003, a hepatitis B titer measured less than 6. The reporting nurse considered the decreased therapeutic response to be possible related to Engerix-B administration. On 03/21/2003, the pt received her 4th injection of Engerix-B.
Sex: M
Vaccine: HEP
Symptoms: Mononucleosis syndrome, Splenomegaly
Clinical narrative: A physician reported the occurrence of mononucleosis-like symptoms in a male of unspecified age who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. The pt's medical history, concurrent conditions and concurrent medications were not reported. On an unspecified date, the pt received his 1st injection of Engerix-B. At an unspecified time post-immunization, the pt experienced mononucleosis-like symptoms. The outcome of these symptoms was not specified. On an unspecified date, the pt received his 2nd injection of Engerix-B. He again experienced mononucleosis-like symptoms, including splenomegaly. The splenomegaly resolved after 2 to 3 months. The outcome of the other mononucleosis-like symptoms was not reported. Comment: The physician indicated that a 2nd subject experienced mononucleosis-like symptoms following receipt of the 1st injection of Engerix-B. However, the pt is not presently identifiable.
Age: 0.58
Sex: F
Vaccine: HEP
Symptoms: Hypersensitivity, Injection site haemorrhage, Injection site urticaria
Clinical narrative: A physician reported the occurrence of a hypersensitivity reaction in an 7-month-old female who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. The pt's medical history, concurrent conditions and concurrent medications were not reported. On 02/07/2003, the pt received an injection of Engerix-B. 24 hours post-immunization, the pt presented to the physician with "intense" urticaria and a progressive ecchymosis of the the right thigh around the injection site. The area of ecchymosis measured 3.9" x 2.7". The physician made a diagnosis of hypersensitivity reaction. No treatment was provided. The physician considered the hypersensitivity reaction to be related to Engerix-B administration. As of 03/10/2003, the hypersensitivity reaction was slowly improving.
Age: 35.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: A nurse reported that a 35-year-old male did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series. The pt's medical history, concurrent conditions and concurrent medications were unknown. The pt received injections of Engerix-B on 03/27/2002 (lot ENG5257A4), 05/20/2002 (lot ENG5257A4) and 11/05/2002 (lot ENG5291A4). 85 days after his 3rd injection of Engerix-B, on 01/29/2003, an unspecified titer was "less than 2". Comment: the reporter indicated that 4 additional subjects did not achieve protective antibody titers following immunization with Engerix-B. Please see reports A0398883A, A0400569A, A0400570A, and A0400571A.
Age: 28.0
Sex: M
Vaccine: HEP
Symptoms: Laboratory test abnormal, Unevaluable event
Clinical narrative: A nurse reported that a 28-year-old male had a decreased response to the hepatitis B vaccine recombinant (Engerix-B) immunization series. The pt's medical history, concurrent conditions and concurrent medications were unknown. The pt received injections of Engerix-B on 03/26/2002 (lot ENG5257A4), 05/21/2002 (lot ENG5263A4) and 11/25/2002 (lot ENG5291A4). 87 days after his 3rd injection of Engerix-B, on 02/20/2003, an unspecified titer was 7. Comment: the reporter indicated that 4 additional subjects did not achieve protective antibody titers following immunization with Engerix-B. Please see reports A0398883A, A0400568A, A0400570A and A0400571A.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: A nurse reported that a 34-year-old female did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series. The pt's medical history, concurrent conditions and concurrent medications were unknown. The pt received injections of Engerix-B on 03/26/2002 (lot ENG5257A4), 05/20/2002 (lot ENG5257A4) and 11/12/2002 (lot ENG5291A4). 90 days after her 3rd injection of Engerix-B, on 02/10/2003, an unspecified titer was "less than 2". Comment: The reporter indicated that 4 additional subjects did not achieve protective antibody titers following immunization with Engerix-B. Please see reports A0398883A, A0400568A, A0400569A and A0400571A.
Age: 29.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: A nurse reported that a 29-year-old male did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series. The pt's medical history, concurrent conditions and concurrent medications were unknown. The pt received injections of Engerix-B on 03/25/2002 (lot ENG5257A4), 05/20/2002 (lot ENG5257A4) and 11/26/2002 (lot ENG5291A4). 42 days after his 3rd injection of Engerix-B, on 01/07/2003, an unspecified titer was "less than 2". Comment: The reporter indicated that 4 additional subjects did not achieve protective antibody titers following immunization with Engerix-B. Please see reports A0398883A, A0400568A, A0400569A and A0400570A.
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: A nurse reported that a female "over 60" tested positive for hepatitis B surface antigen after being vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. The pt's medical history included renal failure (cause not reported) treated with hemodialysis. Concurrent medications were not reported. On 02/26/2003, the pt received a 40-mcg injection of Engerix-B. Nine days later, on 03/07/2003, testing for hepatitis B surface antigen was "positive"; this test had "previously" been "negative". A healthcare professional was consulted regarding the positive test. The reporting nurse considered the event to be possibly related to Engerix-B administration.
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: A nurse reported that a female "over 60" tested positive for hepatitis B surface antigen after being vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. The pt's medical history included renal failure (cause not reported) treated with hemodialysis. Concurrent medications were not reported. On 02/26/2003, the pt received a 40-mcg injection of Engerix-B. Seven days later, on 03/05/2003, testing for hepatitis B surface antigen was "positive", this test had "previously" been "negative". A healthcare professional was consulted regarding the positive test. The reporting nurse considered the event to be possible related to Engerix-B administration.
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: A nurse reported that a female "over 60" tested positive for hepatitis B surface antigen after being vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. The pt's medical history included renal failure (cause not reported) treated with hemodialysis. Concurrent medications were not reported. On 03/03/2003, the pt received a 40-mcg injection of Engerix-B. Two days later, on 03/05/2003, testing for hepatitis B surface antigen was "positive"; this test had "previously" been "negative". A healthcare professional was consulted regarding the positive test. The reporting nurse considered the event to be possibly related to Engerix-B administration.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Drug administration error, Eye irritation, Ocular hyperaemia
Clinical narrative: A medical assistant reported that hepatitis B vaccine recombinant (Engerix-B) was inadvertently sprayed into the eye of a 24-year-old female. The pt's medical history, concurrent conditions and concurrent medications were not reported. On 03/25/2003, while preparing an injection of Engerix-B for administration to a pt, the pt inadvertently sprayed Engerix-B into her eye. "Just after it happened", she experienced "minor" eye redness and irritation. Her eye was flushed with water and the events resolved after 15 minutes.
Sex: M
Vaccine: HEP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Hepatocellular damage
Clinical narrative: This case described the occurrence of liver damage in an adult male pt who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  This report was received from the pt and has not been verified by a physician or other health care professional.  The pt's medical history, concurrent conditions, and concurrent medications were not reported.  The pt stated, "I have records of my lab test done only a year before the vaccine shots started and my liver, and functions, were all normal."  On 05/25/01 the pt reportedly received the 3rd dose of Engerix-B.  At an unknown time post-immunization, in 2001, the pt reported that he experienced "liver damage" with aspartate aminotransferase concentrations twice the reference range and alanine aminotransferase concentrations four times the reference range.  The pt stated that he received medical attention.  He reported that as of 03/20/03, the increased aspartate aminotransferase and alanine aminotransferase concentrations persisted, and the liver damage was "permanent".  The pt declined to provide additional information, and declined to grant authorization to GSK to contact his health care providers.
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Dyspnoea, Heart rate increased, Rash macular
Clinical narrative: A nurse described the occurrence of shortness of breath in a 56 year old female who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  The subject's medical history included vertigo.  The subject experienced no adverse events following previous immunizations.  The subject received no concurrent medications or vaccines.  On 01/13/03, the subject received her first injection of Engerix-B (Lot # ENG5338A6).  On 01/13/03, at 18:00 she began to experience lightheadedness.  At 22:00, she noticed "blotchy" areas on her lower arms.  On 01/14/03 at 02:00, the subject began to experience shortness of breath and "her heart started to race".  These events "progressed through the night."  At 10:00 on 01/14/03, she presented to the local ER.  Her "blotchiness" started to fade.  Unspecified "blood work", chest x-ray and ECG were "fine".  The physician prescribed meclizine hydrochloride (Antivert) 25mg.  The blotchiness, shortness of breath, and racing heart resolved on 01/14/2003; the lightheadedness resolved on approximately 01/15/03.  The reporting nurse considered the events to be possibly related to Engerix-B administration, and the immunization series was discontinued.
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: A nurse reported that a female older than 25 years did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series.  The subject had no known allergies.  Her medical history included "skin problems in the past" and she was "recently"diagnosed with pompholyx.  the pt was also obese.  Concurrent medications were not reported.  The pt received injections of Engerix-B on 04/18/02, 05/23/02, and 10/24/02.  A hepatitis B titer (NOS) measured on 03/19/03 was less than 10.  The subject received her fourth and fifth injections of Engerix B on 03/27/03 and 05/15/03, respectively.  The reporter stated that the pt's lack of response to immunization may have been associated with the pt's pompholyx.
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Anxiety, Dizziness, Headache, Hypersensitivity, Nausea
Clinical narrative: A nurse reported the occurrence of possible anxiety or hypersensitivity in a 26 year old male who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  The subject had no relevant medical history, concurrent conditions, concurrent medications, or concurrent vaccines.  On 03/13/03, the subject received his first injection of Engerix-B (Lot # ENG5338A6).  He was "very anxious about receiving Engerix-B".  After the injection, he experienced nausea, dizziness, and a headache.  The subject's blood pressure and pulse were "fine".  The nurse reported that a diagnosis of "question of hypersensitivity versus anxiety" was made.  The events resolved on 03/13/03.  The reporting nurse considered the events to be possibly related to Engerix-B administration.  The subject received his second injection of Engerix-B on 04/15/03.  No adverse events occurred.
Age: 17.0
Sex: M
Vaccine: HEP
Symptoms: Laboratory test abnormal, Lymphadenopathy, Mononucleosis syndrome
Clinical narrative: A physician reported the occurrence of mononucleosis in a 17 year old male who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  The subject's medical history, concurrent conditions, and concurrent medications were unknown.  In March 2003, the subject received his first injection of Engerix-B.  Two weeks later, in mid-March, the subject presented to the physician's office with lymphadenopathy.  A monospot test was positive for mononucleosis.  As of 04/04/03, the outcome of the mononucleosis was unknown.
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: A nurse reported that a female in her 40's did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series.  The subject had no relevant medical history or concurrent conditions.  Concurrent medications were not reported.  The subject received her first series of Engerix-B injections on 07/27/2001 (Lot # ENG5294B6).  On 05/14/2002, a hepatitis B antibody titer was less than 10 mIU.  The subject received her fourth injection of Engerix-B on 07/26/2002 (Lot # ENG5294B6).  On 09/12/2002, a hepatitis B antibody titer was less than 3 mIU.  The subject received her fifth and sixth injections of Engerix-B on 11/27/2002 (Lot # ENG533A6; not a complete lot number) and 02/19/2003 (Lot # ENG5305A6), respectively.  On 04/09/2003, a hepatitis B antibody titer was less than 3 mIU.
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: A nurse reported that a female in her 30s did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series.  Concurrent conditions included obesity and tobacco use.  The subject was "otherwise healthy".  Concurrent medications were not reported.  The subject received injections of Engerix-B on 06/05/2002 (Lot # ENG5285C6).  On 03/06/2003, a hepatitis B surface antibody titer was less than 3mIU.  The reporting nurse stated that the lack of response to the Engerix-B immunization series could have been associated with the subject's obesity and tobacco use.  On 03/17/2003, the subject received a fourth injection of Engerix-B.
Age: 93.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: A nurse reported that a 93 year old female tested positive for the hepatitis B surface antigen after vaccination with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  The subject's medical history included renal failure treated with hemodialysis.  Concurrent conditions and concurrent medications were not reported.  On 04/01/2003, the subject received her first 40-mcg injection of Engerix-B (Lot # ENG5263A4).  Three days later, on 04/04/2003, the subject tested positive for hepatitis B surface antigen.  She was seen by a physician.  Hepatitis B surface antigen was "negative" on 04/25/2003.  The reporting nurse stated that the positive hepatitis B surface antigen was related to Engerix-B administration.  The reporting nurse stated that the subject had not yet received her second injection of Engerix-B "due to the pt being hospitalized with unrelated causes".
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Gamma-glutamyltransferase increased
Clinical narrative: This report describes the occurrence of increased gamma-glutamyl-transpepeptidase (GGTP) concentration in a 32 year old female.  This report was received from the subject and has not been verified by a physician or other healthcare professional.  The subject's medical history and concurrent conditions were not reported.  The subject reportedly had no history of elevated liver enzymes.  The subject stated that she received no concurrent medications.  The subject reportedly had no adverse experiences following previous immunizations.  The subject stated that she received her second injection of Engerix-B in July 1992.  In December 1992, it was "first noted" that her GGTP concentration was elevated.  The Engerix-B immunization series was discontinued. The subject reported that her GGTP concentration "dropped over time", but recently "was elevated again".  She was seen by a physician.  The subject declined to provide further information, and declined to grant authorization to GSK to contact her physician.
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Pyrexia, Shoulder pain
Clinical narrative: A nurse reported the occurrence of joint pain in an adult female of unspecified age who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. The subject's medical history included an unspecified adverse event following receipt of tetanus toxoid.  Concurrent conditions and medications are not reported.  On approximately 03/15/03, the subject received her first injection of Engerix-B.  "Shortly after administration", the subject developed joint pain including shoulder and knee pain, and was "feverish".  The events resolved without medical attention after approximately two weeks.
Age: 25.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: A nurse reported that an approximately 25 year old male was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis and subsequently tested positive for the hepatitis B surface antigen. The subject's medical history, concurrent conditions, and concurrent medications were not reported.  The subject had exposure to blood on 03/28/03.  The source blood was "negative for hepatitis B".  On 04/07/03, the subject received his first injection of Engerix-B (Lot # ENG5285B6).  On 04/09/03, a hepatitis B surface antigen titer was "positive".  The reporting nurse considered the positive hepatitis B surface antigen titer to be possibly related to Engerix-B administration.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: A pharmacist reported that a subject of unspecified age and gender had a decreased response to hepatitis B vaccine recombinant (Engerix-B).  The subject's medical history, concurrent conditions, and concurrent medications were unknown.  In the year 2001, the subject received an unspecified number of injections of Engerix-B (Lot # ENG3375A4).  Subsequently, on an unspecified date, an unspecified titer was "below normal".  Comment: The reporter indicated that a total of six subjects out of seven vaccinees had "below normal titers" after immunization with Engerix-B Lot # ENG3375A4. However, they are not presently identifiable.
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: A nurse reported that a 47 year old male did not respond to immunization with hepatitis B vaccine recombinant (Engerix-B).  The subject's medical history, concurrent conditions, and concurrent medications were unknown.  The subject received injections of Engerix-B on 08/13/01 (Lot # ENG5179A6), 09/13/01 (Lot # ENG5179A6) and 02/01/02 (Lot # ENG5255D6).  An unspecified titer measured on 05/28/02 was "negative".  The subject then received another series of Engerix-B on 06/19/02 (Lot # ENG5260A6), 08/22/02 (ENG5257A4), and 01/30/03 (Lot # ENG5305C6).  An unspecified titer measured in "late" March 2003 was again "negative".
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Oedema, Oedema peripheral
Clinical narrative: A nurse reported the occurrence of joint swelling in a 48 year old female who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. The vaccine provider submitted this report directly to VAERS.  The subject had no medical history, concurrent conditions, or concurrent medications.  The subject received her first injection of Engerix-B (Lot # ENG5375A2) on 03/25/03; no adverse event was reported.  She received MMRII (Merck) on 04/11/03.  On 04/25/03 at 07:30, she received her second injection of Engerix-B (Lot # ENG5375A2).  On 04/29/03 at approximately 15:00, four days after the second injection of Engerix-B, she developed swelling of her hands, knees, and ankles with no associated pain or redness. As of 05/01/03, the joint swelling had resolved.
Age: 0.4
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Drug administration error, Dyskinesia, Irritability, Miosis, Muscle twitching
Clinical narrative: This report describes the occurrence of twitching in a 4 month old female who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. This report was received from the subject's mother and has not been verified by a physician or other healthcare professional.  Reportedly, the subject had no relevant medical history or concurrent conditions and had no adverse experiences following previous immunizations. The mother reported that on 04/16/03, the subject received her third injection of Engerix-B (Lot # ENG5288A2), administered four months after the first injection rather than the recommended interval of six months.  This occurred because the first injection was not recorded by the hospital at which it was administered.  It was later determined that the hospital had administered the first injection.  On 04/16/2003, she also received injections of DTAP (manufacturer unknown), HIB (Manufacturer unknown), IPV (AP), Prevnar (Lederle).  The mother reported that on 04/17/03, the subject began to be sleepy, "jerky-twitching", cranky, was "not talking babytalk", had a "slight" fever, "pupils small-just dots", was "not three days after the immunizations.  The events reportedly resolved on 04/20/03.
Age: 0.4
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Pyrexia, Somnolence, Speech disorder
Clinical narrative: This report describes the occurrence of twitching in a 4 month old female who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. This report was received from the subject's mother and has not been verified by a physician or other healthcare professional.  Reportedly, the subject had no relevant medical history or concurrent conditions and had no adverse experiences following previous immunizations. The mother reported that on 04/16/03, the subject received her third injection of Engerix-B (Lot # ENG5288A2), administered four months after the first injection rather than the recommended interval of six months.  This occurred because the first injection was not recorded by the hospital at which it was administered.  It was later determined that the hospital had administered the first injection.  On 04/16/2003, she also received injections of DTAP (manufacturer unknown), HIB (Manufacturer unknown), IPV (AP), Prevnar (Lederle).  The mother reported that on 04/17/03, the subject began to be sleepy, "jerky-twitching", cranky, was "not talking babytalk", had a "slight" fever, "pupils small-just dots", was "not three days after the immunizations.  The events reportedly resolved on 04/20/03.
Age: 33.0
Sex: F
Vaccine: HEP, TD
Symptoms: Arthralgia, Oedema peripheral
Clinical narrative: This report describes the occurrence of ankle swelling in a 33 year old female who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. This report was received from the subject, who is a pharmacist.  The subject submitted a report directly to VAERS.  The subject's medical history, concurrent conditions and concurrent medications were not reported.   The subject had no adverse experiences following previous injections of tetanus and diphtheria toxoids adsorbed.  On 04/08/03, the subject received her first injection of Engerix-B.  On the same date, she received an injection of tetanus and diphtheria toxoids (AP).  On 04/15/03, seven days post-immunization, she began to experience pain in her elbows, knees, hips and ankles.  On 04/20/03, the subject noticed swelling of the ankles.  On 04/21/03, the subject was seen by her physician.  Unspecified blood analyses were "negative for rheumatoid arthritis and lupus".  The physician prescribed rofecoxib (Vioxx).  By 04/26/03, the subject found that Vioxx was "not working for pain".  She obtained "slight relief" with ibuprofen.  The subject was seen by a different physician, who prescribed a rapidly-tapering course of methylprednisolone (Medrol Dosepak).  The Medrol Dosepak "helped with the swelling and pan by day one".  On 05/02/03, the subject finished the first Medrol Dosepak, and began experiencing pain and swelling again.  On 05/03/03, the subject began a second Medrol Dosepak.  She noticed improvement "immediately".  As of 05/05/03, the events persisted but had improved.
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: A nurse reported that a female subject of unspecified age did not respond to immunization with hepatitis B vaccine recombinant (Engerix-B). The subject's medical history, concurrent conditions, and concurrent medications were not reported.  The subject received her first and second injections of Engerix-B on unspecified dates.  Lot ENG5285A6 was used for both injections.  On 11/01/02, the subject received her third injection of Engerix-B (Lot # ENG5312A6).  On 05/05/03, an unspecified titer was "negative".
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: A nurse reported that a female subject of unspecified age did not respond to immunization with hepatitis B vaccine recombinant (Engerix-B).  The subject's medical history, concurrent conditions, and concurrent medications were not reported.  On unspecified dates, the subject received her first injection (Lot # ENG525A6) and second injection (Lot # ENG5287A6) of Engerix-B.  On 11/05/02, the subject received her third injection (Lot # ENG5312A6) of Engerix-B.  An unspecified titer measured on 05/10/03 was "negative".  Comment: The lot number provided for the first injection of Engerix-B is not a complete lot #.
Age: 10.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Vomiting
Clinical narrative: A nurse reported the occurrence of vomiting in an 10 year old female who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  The subject had no relevant medical history, concurrent conditions or concurrent medications.  The subject had no adverse experiences following previous immunizations.  On 04/19/02, the subject received her first injection of Engerix-B (Lot # ENG5156A2).  On 04/21/02, two days post-immunization, the subject developed vomiting and fever.  The subject was seen by her primary physician. The events resolved after an unspecified period of time.  At that time, her primary physician considered the events to be unrelated to Engerix-B administration.  On 05/31/02, the subject received her second injection of Engerix-B (Lot # ENG5288A2).  On 06/02/02, two days post-immunization she again developed vomiting and fever.  The subject did not follow up with her physician and the events resolved.  On the office visit for the third injection of Engerix-B, the vaccine provider decided that the events were related to Engerix-B administration and the Engerix-B immunization series was discontinued.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Feeling hot, Injection site oedema, Pruritus
Clinical narrative: A nurse reported the occurrence of an injection site reaction in a 27 year old female who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  The subject's medical history included allergy to PCN.  Concurrent medications were not reported.  The subject received her first injection of Engerix-B (Lot # ENG5303A4) on 11/11/02 and her second injection of Engerix-B (Lot # not provided) on 12/11/02.  She had no adverse experiences following these injections.  On 05/15/03, the subject received her third injection of Engerix-B (Lot # ENG5371A4).  On 05/17/03, two days post-immunization, she developed an injection site reaction characterized by swelling, warmth, and itching.  The injection site reaction resolved after three hours.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Rash pruritic, Urticaria
Clinical narrative: This case described the occurrence of itching and welts in a 47 year old female pt who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  This report was received from the pt and has not been verified by a physician or other health care professional.  The pt reported that she had no known drug allergies.  She stated that she had no adverse experiences following the first injection of Engerix-B.  Other medical history and concurrent conditions were not reported.  Concurrent medications included Accupril.  On an unspecified date in November 2002, the pt received the 2nd dose of Engerix-B.  She reported that, one or two days post-immunization, she began to experience itching on her legs and the insides of her arms.  When she would scratch these areas, welts would develop.  She was seen by her primary physician and a dermatologist.  She stated that she "had to soak in ice cold water".  The events were also treated with diphenhydramine and topical triamcinolone.  She stated that the events resolved after two to four weeks.  She reported that her primary physician and dermatologist considered the events to be unrelated to Engerix-B administration. She planned to consult an allergist.
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: A nurse reported that a 36 year old male did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series.  The subject's medical history, concurrent conditions and concurrent medications were not reported.  The subject received injections of Engerix-B on 08/16/01 (Lot # ENG5239A4), 09/10/01 (Lot # ENG5235A4) and 03/27/02 (Lot # ENG5242A4).  On 05/09/03, a hepatitis B surface antibody titer measured less than 2.0.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Asthenia, Hypersensitivity, Joint swelling, Nausea
Clinical narrative: This report describes the occurrence of an allergic reaction in a 53 year old female who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. This report was received from the subject and has not been verified by a physician or other healthcare professional.  The subject's medical history reportedly included menopause.  Reportedly, the subject had no known drug allergies and no adverse experiences following previous immunizations.  The subject stated that her concurrent medications included montelukast sodium (Singulair), fexofenadine hydrochloride (Allegra), "shots at the allergists", and unspecified vitamins.  The subject stated that on 05/12/03, she received her first injection of Engerix-B; 48 hours post-immunization she developed an allergic reaction characterized by nausea, "slight" fever, soreness in her throat, weakness, and pain and swelling in her joints.  The subject stated that she was seen by a physician. The subject reported that the nausea, fever and sore throat resolved after one day; the weakness and joint swelling resolved after a "few" days.  As of 05/22/03, the joint pain persisted.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Pharyngolaryngeal pain, Pyrexia
Clinical narrative: This report describes the occurrence of an allergic reaction in a 53 year old female who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. This report was received from the subject and has not been verified by a physician or other healthcare professional.  The subject's medical history reportedly included menopause.  Reportedly, the subject had no known drug allergies and no adverse experiences following previous immunizations.  The subject stated that her concurrent medications included montelukast sodium (Singulair), fexofenadine hydrochloride (Allegra), "shots at the allergists", and unspecified vitamins.  The subject stated that on 05/12/03, she received her first injection of Engerix-B; 48 hours post-immunization she developed an allergic reaction characterized by nausea, "slight" fever, soreness in her throat, weakness, and pain and swelling in her joints.  The subject stated that she was seen by a physician. The subject reported that the nausea, fever and sore throat resolved after one day; the weakness and joint swelling resolved after a "few" days.  As of 05/22/03, the joint pain persisted.
Age: 15.0
Sex: F
Vaccine: HEP
Symptoms: Cold sweat, Dizziness, Pallor
Clinical narrative: This case was reported by a nurse and described the occurrence of pallor in a 15 year old female pt who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  The pt's medical history, concurrent conditions and concurrent medications were not reported.  On 04/21/03 the pt received the 1st dose of Engerix-B.  Approximately 3 hours post-immunization, on 04/21/03, the pt experienced pallor, clamminess and dizziness.  A health professional was consulted regarding the events, but no medical treatment was provided.  The events resolved after approximately 30 minutes.  The Engerix-B immunization series was discontinued.  The reporting nurse considered the events were probably related to vaccination with Engerix-B.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective, Hepatitis, Laboratory test abnormal
Clinical narrative: This case was reported by a nurse and described a pt who tested positive for hepatitis B surface antigen after receiving hepatitis B vaccine (manufacturer unknown) for prophylaxis.  The pt's past medical history included renal failure from an unspecified cause, treated with hemodialysis.  Concurrent medications were not reported.  On an unspecified date, the pt received a booster dose of hepatitis B vaccine (manufacturer unknown).  At an unknown time post-immunization, the pt tested positive for hepatitis B surface antigen. The outcome of the event is unknown.
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: This case was reported by a nurse and described an adult male who did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series.  The pt received injections of Engerix-B on 10/18/02 ( Lot # ENG5371A4), 11/18/02 (Lot # ENG5371A4), and 04/18/03 (Lot # ENG5444A4).  On 05/19/03, a hepatitis B surface antibody titer was a "negative".
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a dentist and described a 30 year old female pt who did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series.  On 11/02, the pt received her second injection of Engerix-B. Approximately 6 months post-immunization, in May 2003, the pt had "no antibodies".
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist and described the occurrence of a rash in a 21 year old female pt who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. On an unspecified date, the pt received the 2nd dose of Engerix-B.  At an unknown time, post-immunization, the pt experienced a rash. The outcome of the event is unknown.
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described an adult male pt who did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series.  The pt received injections of Engerix-B on 10/17/02 (LOT # ENG5374A4, 11/18/02 (LOT # ENG5371A4), 04/18/03( LOT # ENG5444A4).  On 05/19/03, a hepatitis B surface antibody titer was "negative".
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: This report was reported by a nurse and described an adult male patient who did not respond to the hepatitis B vaccine recombinant immunization series. The patient received injections of Engerix B on 10/18/02 (lot ENG5371A4), 11/18/02 (lot ENG5371A4), and 4/18/03 (lot ENG5444A4). On 5/19/03, a hepatitis B surface antibody titer was negative.
Sex: F
Vaccine: HEP
Symptoms: Anorexia, Myalgia, Neck pain, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: This case was reported by a nurse and described the occurrence of a sore throat in a female patient who received hepatitis B vaccine recombinant for prophylaxis. On 6/9/03 the patient received the 1st dose of Engerix B. On 6/10/03, one day post immunization, the subject developed a fever greater than 102 degrees F, severe myalgias, anorexia, and digestive upset. On 6/12/03, the patient experienced sore throat and pain in the back of her neck. The subject was seen by the physician. The fever, myalgias, anorexia, and digestive upset had improved but persisted as of 6/12/03. The sore throat and neck pain were unresolved as of 6/12/03. The nurse considered the events were probably related to vaccination with Engerix B.
Sex: F
Vaccine: HEP
Symptoms: Stomach discomfort
Clinical narrative: This case was reported by a nurse and described the occurrence of a sore throat in a female patient who received hepatitis B vaccine recombinant for prophylaxis. On 6/9/03 the patient received the 1st dose of Engerix B. On 6/10/03, one day post immunization, the subject developed a fever greater than 102 degrees F, severe myalgias, anorexia, and digestive upset. On 6/12/03, the patient experienced sore throat and pain in the back of her neck. The subject was seen by the physician. The fever, myalgias, anorexia, and digestive upset had improved but persisted as of 6/12/03. The sore throat and neck pain were unresolved as of 6/12/03. The nurse considered the events were probably related to vaccination with Engerix B.
Sex: F
Vaccine: HEP
Symptoms: Anorexia, Myalgia, Pyrexia, Stomach discomfort
Clinical narrative: This case was reported by a nurse and described the occurrence of digestive upset in female patient who received hepatitis B vaccine recombinant for prophylaxis. On 6/10/03 the patient received the 1st dose of Engerix B. On 6/11/03, one day post immunization, the patient experienced digestive upset, severe myalgias, fever greater than 102 degrees F, and anorexia. The subject had to leave work on 6/12/03. The subject was seen by the physician. The events were unresolved as of 6/12/03. The nurse considered the events were probably related to vaccination with Engerix B.
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Alanine aminotransferase increased
Clinical narrative: This report describes the occurrence of increased alanine aminotransferase concentrations in a 59 year old female patient who received hepatitis B vaccine recombinant for prophylaxis. This report was received from the patient, who is a physician. The patient's medical history and concurrent conditions were not reported. However, alanine aminotransferase concentration was normal in September 2002. Concurrent medications included celecoxib, which was discontinued on 4/29/03. On 4/29/03, the patient received the 4th dose of Engerix B. The reason for receiving a fourth dose was not provided. At an unknown time post immunization, the patient experienced increased concentrations of alanine aminotransferase to 138. The patient consulted another physician regarding the event. The increased alanine aminotransferase concentrations persisted as of 6/17/03, which was six weeks after onset.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Photophobia
Clinical narrative: This case was reported by a nurse and described the occurrence of photophobia in a 45 year old female patient who received hepatitis B vaccine recombinant for prophylaxis. On 5/15/03, the patient received the 1st dose of Engerix B. Two to three hours post immunization, on 5/15/03, the patient experienced a headache. On 5/15/03, at an unspecified time post immunization, the patient also experienced photophobia. The photophobia resolved after 12 hours. The headache was relieved after treatment with paracetamol, but was not totally gone until 5/16/03. A healthcare professional was consulted regarding the events. The nurse considered the events to be not related to Engerix B. On 6/15/03, the patient received the second dose of Engerix B after pre-medication with paracetamol. No adverse event occurred.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: This case was reported by a nurse and described a 33 year old female who did not respond to the hepatitis B vaccine recombinant immunization series. The patient had no relevant medical history. Concurrent medications were not reported. On an unspecified date in 1995, the patient completed a series of Engerix B injections. At an unspecified time post immunization, an unspecified titer revealed that the patient did not have antibodies.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: A nurse reported that an adult patient did not respond to the hepatitis B recombinant immunization series. On 5/20/03, the patient received the third injection of Engerix B, which was injected into the right leg, rather than the recommended deltoid. An unspecified titer performed on 6/19/03 revealed that the patient did not obtain adequate titer levels.