chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: This report describes 10 of 11 vaccinees who failed to respond to a 3 injection series of Hep-B vaccine (Engerix-B). Seven were male, 4 were female, and all but 1 (male) were between the ages of 30 and 45 years. All vaccinee completed the series with lot ENG3351C6 (expiry unknown). Six months after completing the series, the pts had sero-converted. That pt was male, and was the only pt older than 45 years of age. He could not remember if he had had the vaccine before and the reporter also stated that he could have had antibody protection because of previous exposure. As of 5/3/02, the outcomes of the events were unknown. Since a specific vaccinee has not been identified, this report is considered not reportable.
Sex: F
Vaccine: HEP
Symptoms: Eye swelling, Hypersensitivity, Influenza like illness, Pain
Clinical narrative: Eye swelling, Pain NOS, cell mediated allergic reaction, Report A0368358A describes puffy eyes in an adult (over 40 y.o.) female who received Hep B vaccine recombinant (Engerix-B). The medical history included allergy to acetaminophen hydrocodone bitartrate (Vicodin). No concurrent conditions were provided. There were no concurrent medications. The vaccines had no adverse experiences following receipt of her first injection of Engerix-B. On 5/8/02, the vaccinee received her second injection of Engerix-B. Later that day, she experienced puffy eyes, without itching and "an achy feeling, like the flu". The vaccinee reported these symptoms via telephone. The reporter was "concerned that this may be a delayed hypersensitivity reaction from the first shot." The events persisted the next day. The reporting nurse considered the events to be probably not related to Engerix-B administration.
Sex: F
Vaccine: HEP
Symptoms: Crying, Drug tolerance decreased, Gastrooesophageal reflux disease, Hypersensitivity, Pain
Clinical narrative: The pt's medical history reportedly included reflux treated with Zantac; intolerance to breast milk, and allergies to dairy products, rice, peanuts, barley, Baker's yeast, and "possibly" wheat. In July 1999, while still in the hospital after birth, the neonate rec'd an injection of hepatitis B vaccine(manufacturer unknown). Subsequently, she was reported "up all night, restless, crying, seemed to be in pain". the outcomes of the event were not specified.
Sex: F
Vaccine: HEP
Symptoms: Restlessness
Clinical narrative: The pt's medical history reportedly included reflux treated with Zantac; intolerance to breast milk, and allergies to dairy products, rice, peanuts, barley, Baker's yeast, and "possibly" wheat. In July 1999, while still in the hospital after birth, the neonate rec'd an injection of hepatitis B vaccine(manufacturer unknown). Subsequently, she was reported "up all night, restless, crying, seemed to be in pain". the outcomes of the event were not specified.
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: Confusional state
Clinical narrative: On 5/2/02, the pt rec'd her first injection of Engerix-B. One day later, on 5/3/02, the pt experienced confusion. According to the physician's assistant, it was" thought at first the pt may have had a head injury due to presentation of symptoms but no information to support that".Treatment, if any, was not specified. The reporter considered the events to be unrelated to Engerix-B. The most recent information, rec'd on 0/0/02, reported that the event resolved by 5/16/02.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Body temperature increased, Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: Report A0369042A describes warm inject site in a 27 y.o. female vaccine who received Hep B vaccine recombinant (Engerix-B). This report was received from a PT and has not been verified by a physician or other health care professional. The vaccinee had no concurrent medical conditions and was taking no concurrent medications. She had no adverse experiences following receipt of prior immunizations. On 5/13/02,the vaccinee received an injection of Engerix-B. On the same date, post immunization, the vaccinee experienced an elevated temp. reported to have been "104". On 5/14/02, the inject site was reportedly red, warm, tender, and swollen. Treatment was not provided. The most recent info. provided on 5/16/02, reports the outcome to be unresolved.
Age: 75.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Report A0369096A describes a positive test for Hep B surface antigen in a 75 y.o. male who received Hep B vaccine recombinant (Engerix-B). The vaccinee was a hemodialysis patient. Concurrent medications were not specified. On 5/7/02, the vaccinee received a 40 mcg "booster" injection of Engerix-B. On 5/9/02, an unspecified "titer test" was positive for Hep B surface antigen. The reporting nurse had been told that "the false positive may have been due to a reaction with heparin when using the red tube for the collection of blood." A repeat titer was scheduled for one month post-vaccination. The reporter stated that the positive test for Hep B surface antigen may possibly be related to Engerix-B administration.
Age: 77.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive
Clinical narrative: Report A0369098A describes a positive test for Hep surface B antigen in a 77 y.o. female who received Hep B vaccine recombinant (Engerix-B). The vaccinee was a hemodialysis PT. Concurrent medications were not specified. On 5/7/02, an unspecified "titer test" was positive for Hep B surface antigen. The reporting nurse had been told that "the false positive may have been due to a reaction with heparin when using the red tube for the collection of blood." A repeat titer was scheduled for one month post-vaccination. The reporter stated that the positive test for Hep B surface antigen may possibly be related to Engerix-B administration.
Age: 23.0
Sex: M
Vaccine: HEP, HEPA, YF
Symptoms: Arthritis
Clinical narrative: A MD reported the occurrence of arthritis in a 23-y.o. male who received Hep B vaccine recombinant (Engerix-B). Medical history, concurrent conditions, and concurrent medications were not provided. On 5/1/02, the subject received Hep B vaccine recombinant, Hep A vaccine inactivated, and yellow fever vaccine. ON 6/6/02, 5 days post immunization, the subject experienced arthritis. On 5/10/02, the following tests were performed: antinuclear antibody (ANA) was 1:40 (reference range unspecified) c-reactive protein (CRP) elevated, rheumatoid factor (RA) within normal limit (WNL), and antistreptolysin o titer (ASO) within normal limit (please see relevant diagnostic tests for details). It was not indicated if treatment was given for the event. The outcome of the event was reported to have improved. The reporting physician considered the even to be possibly related to the injection of Hep B vaccine recombinant (Engerix-B).
Sex: M
Vaccine: HEP
Symptoms: Anaphylactic reaction
Clinical narrative: Report A0369578A describes an anaphylactic reaction in a male vaccinee of unspecified age who received Hep B vaccine recombinant (Engerix-B). Medical history, concurrent conditions, and concurrent medications were not specified. The vaccinee had an unspecified reaction to "pertussis" as a child. He received measles, mumps, and rubella vaccine and meningococcal vaccine at unspecified times without reaction. On an unspecified date, the vaccinee received an injection of Engerix-B; it was not known if he had received previous injections of Engerix-B. Subsequently, he experienced an anaphylactic reaction. As of 5/22/02, the anaphylactic reaction had resolved. Anaphylactic reaction is considered GSK medically serious.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Hypokinesia, Injection site reaction
Clinical narrative: Report A0369656A described a 12 y.o. female who experienced an inject site reaction after receiving Hep B vaccine recombinant (Engerix-B). The medical history included juvenile rheumatoid arthritis. The PT was allergic to naproxen (Naprosyn). Concurrent medications included rofecoxib (Vioxx), minocycline, and ethinylestradiol/ noresthisterone (Necon). On 4/12/02, the vaccinee received her first injection of Engerix-B (lot ENG5167A2; expiry, 6/9/02). On approximately 5/3/02, she experienced inject site tenderness and "could not move her arm." She was seen by the rheumatologist (findings unknown). On 5/20/02, the vaccinee received her 2nd injection of Engerix-B (lot ENG5167A2; expiry 6/9/02). On 5/23/02, she again experienced tenderness at the inject site and "could not move arm." She returned to the pediatrician's office (findings unknown). The reporter stated that the events could have been associated w/the subject's juvenile rheumatoid arthritis. The events revolved on 5/24/02.
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Injection site oedema, Rash
Clinical narrative: Report A0370072A described a rash in a 26 y.o. male subject who received Hep B vaccine recombinant (Engerix-B). Medical history, concurrent conditions, and concurrent medications were not provided. On 5/23/02, the subject received his 2nd injection of Engerix-B (lot # ENG5252A2). Immediately following the injection, the subject experienced an inject site reaction characterized by swelling. Later that evening, the subject experienced a "heat-like rash" on his upper body after he played a game of basketball. The inject site swelling was treated with ice and most of it resolved w/in 20 mins. Treatment for the rash was not specified but it reportedly resolved w/in 3-4 hrs. By 5/24/02, the inject site reaction of swelling had completely resolved. The physician advised the subject to contact the student health physician regarding this info. Additionally, the physician recommended that the subject receive his next injection at a "medical facility that has access to emergency facilities." on 9/17/02, the reporting nurse considered only the inject site swelling to be related to Engerix-B administration.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Report A0370074A describes a facial rash in a 39 y.o. female who received Hep B vaccine recombinant (Engerix-B). This report was initially received from a nurse via Merck & Co. The medical history, concurrent conditions, and concurrent medications were not specified. On 12/8/98 and 1/8/99, the vaccinee received her first and 2nd injections of Engerix-B, respectively. On 1/9/99, she experienced a facial rash and sought medical attention for this event. As of 5/29/02, the outcome of the event was unknown.
Age: 48.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Therapy non-responder. Report A0370075A describes a 48 y.o. male who did not respond to the Hep B vaccine recombinant (Engerix-B) immunization series. The medical history, concurrent conditions, and concurrent medications were not specified. On 9/11/01, 10/11/01, and 3/11/02, the vaccinee received his first (lot ENG5168A2; expiry 5/14/02), second (lot ENG5168A2; expiry, 5/14/02), and third (lot ENG5272A2; expiry, 8/20/03) injections of Engerix-B, respectively. A titer (NOS) drawn for this vaccinee on 5/16/02, 66 days after the 3rd injection of Engerix-B, was "negative"; measurable titers were not obtained." The reporter stated that the event was probably related to Engerix-B.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Alopecia
Clinical narrative: Report A0370076A describes hair loss in a 17 y.o. female who received Hep B vaccine recombinant (Engerix-B). This report was received from the mother of the vaccinee and has not been verified by a physician or other healthcare professional. The medical history and concurrent conditions were not specified. Concurrent medications reportedly included thiamazole (Tapazole). According to the mother, the vaccinee received her first injection of Engerix-B in June 99. Reportedly, in the summer & fall of 99, the vaccinee "experienced hair loss from her hair line above her temples - similar to how a man loses his hair. It grew back later." Reportedly, the vaccinee received her second and 3rd injections of Engerix-B in July & October 2000, respectively. The hair loss reportedly revolved in winter 2000.
Age: 10.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Dyspepsia, Pallor
Clinical narrative: Report A0370296A describes pallor in a 10 y.o. male who received Hep B vaccine (manuf'r unknown). Medical history, concurrent conditions, and concurrent medications were not provided. In November 01, the subject received his first injection of Hep B vaccine ("may have been Engerix-B but not sure"). Reportedly, 15 mins after receiving the injection he experienced "dizziness, pale and, sick to stomach." Treatment was not specified. Info. received on 5/30/02 reports that all symptoms were resolved 1 day following the injection. Follow-up received from the physician on 9/10/02 specified that the events were reported to the physician by the mother and did not occur in his office. Since that episode, a 2nd Hep B vaccine was given to the subject by the physician in his office (date unspecified) "without any ill effect."
Sex: M
Vaccine: HEP
Symptoms: Photosensitivity reaction, Rash
Clinical narrative: Report A0370297A describes sensitivity to heat in a male vaccinee of unspecified age who received Hep B vaccine recombinant (Engerix-B) for "work-related possible exposure." This report was received from the vaccinee and has not been verified by a physician or other healthcare professional. The vaccinee reportedly had no relevant medical history and received no concurrent medications. Reportedly, he had not experienced any adverse events following previous vaccinations. According to the vaccinee, in June and July 2001 he received his first & 2nd injections of Engerix-B, respectively. It was reported that beginning in approximately August 01, he began to experience sensitivity to heat and sun. Reportedly, his skin broke out in a rash, "small bumps appear that are very itchy." The vaccinee stated that he can now tolerate the cold better than the heat. The Engerix-B vaccination series was reportedly discontinued. Reportedly, no medical attention was required. As of 7/1/02, the outcomes of the events were reportedly ongoing.
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This report describes a female in her 30's who did not respond (therapy non-responder) to 3 injections of Hep B vaccine recombinant (Engerix-B). This report was received from the subject who is a nurse and has been medically confirmed. The subject's medical history included an allergy to sulfa and airborne allergy. 2 yrs ago, the subject had an allergic reaction to a flu vaccine (NOS) that contained sulfur component/base. There was no concomitant medication. In the early 90's, the subject received 3 injections of Hep B vaccine (Engerix-B). Approximately 2 to 3 yrs after completion of the vaccination series, the subject's titer tests were checked and came back negative. It was determined that the subject did not seroconvert. A 4th injection of Engerix-B was administered. The PT had repeat titers drawn which were positive nothing seroconversion. The reporter considered the lack of seroconversion following the 3rd injection of Engerix-B to be probably related to the Engerix-B administered.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Oedema, Rash maculo-papular, Skin disorder, Skin ulcer
Clinical narrative: This report describes the occurrence of pityriasis lichenoides et varioliformis acuta in a 12 y.o. female who received Hep B vaccine recombinant (Engerix-B). This report was received from the subject's mother and has been confirmed by a dermatologist. The subject's medical history, concurrent conditions, and concomitant medications were not provided. The subject experienced no adverse events following receipt of her first injection of Engerix-B. On 1/8/02, the subject received her 2nd injection of Engerix-B. On 1/10/02, 2 days post immunization, she developed a blotchy rash all over her body. On that date, the subject presented to her primary care physician and again on 1/15/02 for the body rash. Initially the rash was thought to be scabies; however, it did not respond to treatment. The subject was subsequently treated for eczema; however, the rash did not improve significantly with steroid cream (NOS). The subject's mother stated that the rash "did seem to get better for a period of time, but would keep breaking out again in a rash off and and on since January on her legs and arms the most." Subsequently, the subject was referred to a dermatologist. The subject presented to the dermatologist on 1/29/02, with a 2 to 3 week-old itchy rash on her trunk and extremities. Initially the subject was suspected of having scabies or contact dermatitis and was treated with permethrin (Elkimite) and fluocinonide topically; however, there was no relief. Additionally, the dermatologist suspected possible pityriasis lichenoides et varioliformis acuta (PLVA), therefore; fluticasone propionate (Cutavate) was prescribed. On 2/7/02, the subject's mother called to report that the eruption had worsened. Upon the subject's return visit on 2/15/02, the dermatologist noted that the rash was spreading further and a diagnosis of pityriasis lichenoides et varioliformia acuta (PLVA) was confirmed. The dermatologist advised the subject to continue treatment with Cutivate as he did see some benefit from using the cream. Additional treatment included erythromycin 200 mg 3 times daily by mouth. On 6/10/02, the subject's mother called to report that her daughter did not get new lesions; however, complained of increased pigmentation from old lesions. The subject was treated with hydroquinone (Alustra) cream to be used twice daily topically. According to the dermatologist, the blotchy rash resolved with sequela in April 2002 and was considered to be possibly related to the second injection of Engerix-B. However, he also indicated that "it is possible the rash represented pityriasis lichenoides acuta, an idiopathic skin eruption unrelated to the vaccine, but this is uncertain."
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site reaction, Pruritus
Clinical narrative: Report A0371140A describes inject site react in a 36 y.o. female who received Hep B vaccine recombinant (Engerix-B). This report was received from a nurse. Medical history included "skin reaction" to powder in gloves and similar type items such a Banbaids. Concurrent conditions were not specified, Concomitant medications included thyroxine sodium (Synthroid), vitamins (NOS), and calcium. Reportedly, the PT had received a Hep B vaccination series in the past (date unspecified) with a vaccine other than Engerix-B. The nurse also stated that an unspecified "titer test" did not reveal protective antibodies. The interval between completion of the immunization series and titer determination was not known. Therefore, the vaccination series were repeated on 5/3/02 using Engerix-B. 2 to 4 hrs after receiving her first injection in the repeat series, the PT experienced an inject site reaction characterized by redness "the size of a dime" and itching. The PT treated the area by applying ice for relief. The redness and itching were reported to have resolved the following day. The reporting nurse considered the events to be probably related to the immunization.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Hypertonia, Laryngospasm, Pain, Rash
Clinical narrative: Report A0371257A described the occurrence of throat swelling in a 23 y.o. female who received Hep B vaccine recombinant (Engerix-B). This report was received from the subject's sister and had not been verified by a physician or other health care professional. There was no relevant medical history or concurrent conditions. Concomitant medications included "birth control" (NOS). The subject experienced no adverse events following receipt of prior immunization. On 6/5/02, the subject received her first injection of Engerix-B in the left arm. W/in 48 hrs of her immunization, the subject experienced stiffness, pain, rash, and swollen throat. Reportedly,the symptoms worsened and the subject had to go to the emergency rm. where she was treated with prednisone and was instructed to take diphenhydramine hydrochloride (Benadryl). The rash and swollen throat was reported to have improved, however, the stiffness and pain were unresolved.
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Report A0371311A describes an adult female (age unspecified) who did not respond to the first 3 injection immunization series with Hep B vaccine (mft'r unknown). This report was received from the subject, who is a nurse. Medical history, concurrent conditions, and concurrent medications were not specified. Approximately 10-12 yrs ago, the subject received 3 injections of Hep B vaccine and reported that she "did not respond". Subsequently, she was given a 4th injection and titer was measured. The subject stated she "finally" responded to the 4th injection.
Sex: U
Vaccine: HEP
Symptoms: Injection site inflammation
Clinical narrative: Report A0371653A describes burning at the inject site in a PT (age, gender unspecified) who received Hep B vaccine recombinant (Engerix-B). This report was received from a nurse via a GSK sales rep. There was no relevant medical history, concurrent conditions, or concomitant medications provided. The vaccinee experienced no adverse events following receipt of the first injection of Engerix-B. On an unspecified date, the vaccinee received a 2nd injection of Engerix-B and immediately experienced burning at the inject site. The reaction did not last long and was reported to have resolved.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site reaction, Rash, Urticaria
Clinical narrative: This report describes the occurrence of an inject site reaction in a 27 y.o. female who received Hep B vaccine recombinant (Engerix-B). This report was received from the subject who is a pharmacist and has been medically confirmed. The subject's medical history included environmental allergies and allergy to thimerosal (1999). She denied any tobacco use and indicated that she is a social drinker (approximately one drink/month). The subject experienced a "similar type of reaction" (red, pimply rash with some hives) with the tuberculin (TB) skin test a few yrs ago and approximately 36 hrs after receiving her first injection of Hep B vaccine series with Recombivax adult dose (May 02). Concurrent medications included ethinyl estradiol/norgestrel (Lo-Ovral) and acetaminophen (Tylenol). Reportedly, the subject noted that Recombivax adult and the TB skin test, both contained thimerosal. Therefore, for her second injection of Hep B vaccine, she opted to receive Engerix-B pediatric, which she thought did not contain thimerosal. On 6/13/02, the subject received her second injection of Hep B vaccine recombinant (Engerix-B pediatric) in the right arm. Reportedly, for this 2nd injection, 2 doses of Engerix-B pediatric were drawn up in one syringe and was given as one adult strength injection. On the same day, post immunization, the subject developed an inject site reaction characterized by a red, pimply rash with some hives. It was not indicated if treatment was given for the events. The symptoms were reported to have resolved as of 6/16/02. The reporter considered the events to be related to the 2nd injection of Engerix-B pediatric, since she realized after the injection that Engerix-B may have trace amounts of thimerosal. Additionally, the subject realized that she is planning to receive her third dose of the series with the Recombivax pediatric, which she believes, does not contain thimerosal.
Age: 7.0
Sex: F
Vaccine: HEP
Symptoms: Amnesia
Clinical narrative: This report describes the occurrence of spaciness in a 7 y.o. female who received Hep B vaccine recombinant (Engerix-B). This report was received from the subject's mother and had been verified by a physician. The subject had no relevant medical history, concurrent medical conditions,or concurrent medications. The subject experienced no adverse events following receipt of the 1st and 2nd injections of Engerix-B. The subject's mother reported that on 4/12/99, the same night after receiving the third injection of Engerix-B (lot #ENG2919A2), her daughter became "spacey" and "had problems with short term memory". Reportedly, per the mother, the symptoms have resolved with an unspecified sequelae. This subject's mother also stated that her daughter "is having problems with learning in school".
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Chills, Dizziness, Flushing, Hyperhidrosis
Clinical narrative: This report described the occurrence of an uneasy feeling in an adult male who received Hep B vaccine recombinant (Engerix-B). There was no relevant medical history or concurrent conditions. The subject reported rare alcohol use and denied tobacco use. Concurrent medications were not provided. On 5/16/02, the subject received his first injection of Engerix-B. W/in one hour post immunization he experienced dizziness, sweating, malaise, chills, weakness, flushing, low grade fever of 100.4 degrees F and "felt uneasy." The subject reportedly went home from work and slept, and after 4 - 6 hrs, he felt better. The immunization series was discontinued per the subject's request as he did not feel comfortable receiving the remainder of the series. The reporter stated the events were possibly related to the treatment with Engerix-B. As of 5/17/02 the adverse events had resolved.
Sex: M
Vaccine: HEP
Symptoms: Malaise, Pyrexia
Clinical narrative: This report described the occurrence of an uneasy feeling in an adult male who received Hep B vaccine recombinant (Engerix-B). There was no relevant medical history or concurrent conditions. The subject reported rare alcohol use and denied tobacco use. Concurrent medications were not provided. On 5/16/02, the subject received his first injection of Engerix-B. W/in one hour post immunization he experienced dizziness, sweating, malaise, chills, weakness, flushing, low grade fever of 100.4 degrees F and "felt uneasy." The subject reportedly went home from work and slept, and after 4 - 6 hrs, he felt better. The immunization series was discontinued per the subject's request as he did not feel comfortable receiving the remainder of the series. The reporter stated the events were possibly related to the treatment with Engerix-B. As of 5/17/02 the adverse events had resolved.
Age: 44.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This report describes a 44 y.o. male who did not respond to the Hep B vaccine recombinant (Engerix-B) immunization series. The subject's medical history and concurrent conditions included hypertension (onset 2000). Concurrent medications were not specified. The vaccinee was not obese or a smoker. The vaccinee received Engerix-B on 9/15/01 (lot #ENG3382A4), 10/13/01 (lot ENG5178A4) and 4/5/02 (lot ENG5178A4). A Hep B surface antibody titer, measured on 5/25/02, 50 days after the 3rd injection of Engerix-B was "negative."
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Alopecia, Fatigue, Pruritus
Clinical narrative: This report describes hair loss in a 44 y.o. female who was vaccinated with Hep B vaccine recombinant (Engerix-B) for prophylaxis. The subject's medical history included allergy to ampicillin. Concurrent medications were not specified. The subject had not experienced any adverse events following previous immunizations. On 6/3/02, the subject received her first injection of Engerix-B. By approximately 6/10/02, she experienced hair loss, skin itching, and fatigue. The events "came on gradually." The subject was seen by a physician. The Engerix-B immunization series was discontinued. As of 10/8/02, the events has "improved".
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive
Clinical narrative: This report describes a male subject of unspecified age who tested positive for Hep B surface antigen after being vaccinated with Hep B vaccine recombinant (Engerix-B) for prophylaxis. The subject's medical history included "renal dysfunction resulting in hemodialysis." Concurrent medications were unknown. On an unspecified date, the subject received his first 40 mcg injection of Engerix-B. Subsequently, the subject tested positive for Hep B surface antigen. "The PT's liver function tests were all within normal limits, as they have consistently been in the past."
Age: 49.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Hepatitis B surface antigen positive
Clinical narrative: This report describes a 49 y.o. male who did not respond to the Hep B vaccine recombinant (Engerix-B) immunization series. There was no relevant medical history, concurrent condition, or concurrent medication. The subject received three injections of Engerix-B on a 0, 1, and 6 month schedule. The 3rd injections was administered on 4/11/02 (log #NG528A2; expiry 9/18/03). 1 week prior to this injection, on 4/4/02, Hep B surface antibody titer was positive. However Hep B surface antibody titer measured in July 02 was "negative"; he was a "low responder" with a titer value of <0.1 (reference range, 0.0 - 2.0). Comment: The reporter indicated that the subject received Engerix-B from lot ENG5282A2; however, this is not a valid Engerix-B lot number.
Age: 32.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Dyspnoea, Erythema nodosum, Pruritus, Rash
Clinical narrative: This report describes erythema nodosum in a 32 y.o. male who received Hep B vaccine recombinant (Engerix-B). Medical history included allergy induced asthma as a child. On 7/19/02, the subject received his 2nd injection of Engerix-B. Shortly after receiving the injection, he experienced a rash and itching on both ankles. Two days later, on 7/22/02, he experienced shortness of breath, dizziness, and lightheadedness. The subject was seen at the physician's office on 7/22/02 stating that his symptoms had not improved. He further stated that the symptoms were similar to the symptoms he had when he was diagnosed with Asthma as a child. The subject was treated with diphenhydramine. The events were reported to persist. Info. received from the physician on 10/16/02, reports that the subject "suffered from Erythema nodosum, a side effect from Hep B vaccine."
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This report describes a male subject (age unspec'd) who did not respond to immunization with Hep B vaccine. This report was received from a nurse. Medical history, concurrent conditions, and concurrent medications were not specified. The nurse reported that the subject received the Hep B vaccine immunizations series (dates unspec'd) and "was a non-or low-responder".
Sex: F
Vaccine: HEP
Symptoms: Condition aggravated, Multiple sclerosis
Clinical narrative: This report describes an exacerbation of multiple sclerosis in a female of unspecified age who received Hep B vaccine recombinant (Engerix-B). This report was received from a lawyer and has not been verified by a MD or other healthcare professional. The medical history included multiple sclerosis. Concurrent conditions and concurrent medications were not specified. On an unspecified date, the vaccinee received an injection of Engerix-B; it was not known if she had received previous injections of Engerix-B. It was reported that, "shortly after" immunization, the vaccinee experienced an exacerbation of multiple sclerosis. Treatment and outcome were not provided. Exacerbation of multiple sclerosis is considered GSK medically serious.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: A nurse reported that an unidentified adult subject did not seroconvert after receiving 3 injections of Hep B vaccine recombinant (Engerix-B). The subject's medical history, concurrent medical conditions, and concurrent medications were not provided. On unspecified dates, the subject received injections of Engerix-B at 0, 1, and 6 months. 2 months following the 3rd dose, the subject's "titer" (NOS) was less than two indicating that the subject did not seroconvert. The reporting nurse stated that she has investigated the "Lab" to see if there was a problem there. (Outcome not specified.) Treatment and outcome were not provided. Comment: The reporter indicated that four subjects have experienced this event, however, identifiers were not provided. Therefore, this report is considered not reportable.
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: A nurse reported that an adult male subject was negative for antibodies to "Hep B antigen" after receiving 3 injections of Hep B vaccine recombinant (Engerix-B). The subject's medical history, concurrent medical conditions, and concurrent medications were not provided. The subject received injections of Engerix-B in Sept. 01 (lot # ENG5208A2), Oct. 01 (Lot # ENG5235A4), and May 02 (lot # ENG5299A4). Approximately 1 to 2 months following completion of the series, a "titer test" (NOS) was performed and the results were negative for antibodies. The reporting nurse considered the event probably related to Engerix-B administration.
Age: 0.4
Sex: M
Vaccine: HEP
Symptoms: Coma, Hypotension, Hypotonia, Stupor
Clinical narrative: This report describes a hypotonic-hyporesponsive episode in a 6 month old male who received Hep B vaccine recombinant (Engerix-B). The subject's medical history, concurrent conditions, and concurrent medications were not specified. On an unspecified date, the subject received his first injection of Engerix-B. W/in 24 hrs, he experienced a hypotonic-hyporesponsive episode characterized by hypotonnia, placidity, non-responsiveness, and decreased blood pressure. The infant was seen by a physician and recovered.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This report describes a 45 y.o. female who did not respond to the Hep B vaccine recombinant (Engerix-B) immunization series. The subject's medical history included diabetes mellitus and hypertension. Concurrent medications included amlodipine besylate/benazepril hydrochloride (Lotrel) and glipizide (Glucotrol XL). She received no concurrent vaccines. The subject experienced no adverse events following previous immunizations. The subject received Engerix-B on 11/27/01, 12/28/01, and 5/23/02. Lots of vaccine administered were ENG5239A4 (1st two injections) and ENG5299A4 (3rd injection). A titer (NOS) measured on 7/23/02, 2 months after the 3rd injection, showed a value of "0" (10 being considered a protective level). The reporting nurse considered this non-response to be possibly related to Engerix-B administration.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This report describes a 58 y.o. female who did not respond to the Hep B vaccine recombinant (Engerix-B) immunization series. The subject is a moderate cigarette smoker. No other medical history, concurrent conditions, or concurrent medications were reported. She received no concurrent vaccines. The subject experienced no adverse events following previous immunizations. The subject's birth weight was 6.68 pounds. The subject received Engerix-B on 8/1/01, 9/11/01, and 2/5/02. Lots of vaccine administered were ENG5235A4 (1st 2 injections) and ENG5262A4 (3rd injection). A titer (NOS) measured 2 months after the 3rd injection on 4/5/02 showed a value of "4" (10 being considered a protective level). The reporting nurse considered the inability to respond to the Engerix-B immunization series as possibly related to Engerix-B administration.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This report described a 48 y.o. female who did not respond to the Hep B vaccine recombinant (Engerix-B) immunization series. Medical history included tobacco use. No concurrent conditions or concurrent medications were reported. The subject had no adverse experiences following receipt of previous vaccinations. She received no concurrent vaccines. The subject received Engerix-B on 10/24/01, 11/27/01, and 4/24/02. Lots of vaccine administered were ENG5239A4 (1st injection), 5242A4 (2nd injection), and 5262A4 (3rd injection). A titer measured on 6/24/02, 2 months after the 3rd injection of Engerix-B showed a value of "0" (10 being considered a protective level). The reporting nurse considered the non-response to be possibly related to Engerix-B administration.
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Influenza like illness, Pyrexia
Clinical narrative: A physician reported that occurrence of flu-like symptoms in a male who was vaccinated with Hep B vaccine recombinant (Engerix-B). The subject's medical history or concurrent medical conditions were not specified. On an unspecified date, the subject received the first injection of Hep B vaccine recombinant (20 mcg) intramuscularly in an unspecified arm. Concurrent medications included tetanus-diphtheria toxoid (unknown mnft'r) and a unspecified vaccine (unknown mnft'r). A few days later, he developed arthralgia, a low grade fever, and flu-like symptoms. The events were reported to have resolved within one day.
Age: 53.0
Sex: M
Vaccine: HEP
Symptoms: Blood pressure decreased, Hypoaesthesia, Nausea, Pyrexia
Clinical narrative: He had experienced no adverse events following receipt of his 1st injection of Engerix-B. On 8/14/02, the subject received his 2nd injection of Engerix-B (lot 5305B6). A "few" hours later, he complained of nausea and numbness in the arm. He was found to have a fever of 102F and decreased blood pressure (84/60mmHg). He was treated in the infirmary with unspecified IV fluids, Tylenol for fever and Vistaril for nausea. The subject spent the night in the infirmary and was discharged in the AM of 8/15/02. At that time, his temperature was 97.8F, his blood pressure was 120/80mmHg and he had no redness or soreness at the injection site. As of 8/15/02, the events had resolved. The Engerix-B immunization series was discontinued. The nurse mentioned that the subject ran every day and he did run on 8/14/02. The reporting nurse stated that the events were not related to Engerix-B administration. She said that the weather in her locale was very hot and humid on 8/14/02 and questioned whether the subject's running might have caused these events.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: A nurse reported the occurrence of abdominal cramps in a 39 y.o. female who was vaccinated w/Hep B vaccine recombinant (Engerix-B) for prophylaxis. During the subject's last pregnancy she was "labeled as a Hep carrier". An unspecified Hep A titer was negative and an unspecified Hep B titer was >2 (units and reference range unspecified). Concurrent medications included birth control pills (NOS), loratadine (Claritin), fluoxetine (Prozac), formoterol fumarate (Foradil), and levothyroxine sodium (Unithyroid). On 8/13/02, the subject received her 1st injection of Engerix-B (lot ENG530348; expiry 11/22/03). On 8/14/02, she experienced abdominal cramping and diarrhea. As of 8/16/02, the events were ongoing, but medical attention was not required. Comment: The reporter indicated that the subject received lot ENG530348; however, this is not a valid Engerix-B lot #.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Back pain, Hypersensitivity, Pain, Paraesthesia, Skin disorder
Clinical narrative: A physician via Merck Pharmaceuticals reported the occurrence of an allergic reaction in a 46 y.o. female who was vaccinated with Hep B recombinant (Engerix-B) for prophylaxis. The subject had previously experienced an allergic reaction manifested by persistent eye redness to a contact lens solution containing thimerosal. She subsequently had to use a thimerosal-free solution. Concurrent medications were not specified. On 4/23/91 at 9:00, the vaccinee received her first injection of Engerix-B (lot ENG630A4; expiry, 2/23/92). W/in 6 hrs post-immunization she experienced body aches, and back ache. She subsequently experienced cutaneous sensitivity and migratory paresthesias which persisted for several weeks. The physician made a diagnosis of "allergic reaction to the thimerosal." The reporting physician stated that the events were possibly related to Engerix-B administration. The Engerix-B immunization series was discontinued. The events revolved in May 1991.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive
Clinical narrative: A nurse reported the occurrence of a positive Hep B surface antigen result in a neonate of unspecified gender who was vaccinated w/Hep B vaccine recombinant (Engerix-B) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were unknown. On an unspecified date, the subject received the first injection of Engerix-B. Subsequently, the subject tested positive for Hep B surface antigen.
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: A nurse reported the inability of a female in her 40's to respond to her 3rd injection of Hep B vaccine recombinant (Engerix-B). The subject had reportedly had an unspecified "immune disorder". However, the PT's physician indicated that this disorder "would not interfere with responding to the vaccine." Concurrent medications were unknown. The subject received Engerix-B in Sept. 01, Oct. 01, and Apr. 02. An unspecified titer measures 1 to 2 months after the 3rd injection listed a value "<10" (units and reference range unspecified). The subject received her4th injection of Engerix-B on 6/6/02 (lot ENG5270A4). An unspecified titer measured on 8/9/02, 64 days after the 4th injection, listed a value of "<10" (units and reference range unspecified). As of 8/21/02, the outcome of the event was unknown.
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Arthritis, Chest pain, Fatigue, Headache
Clinical narrative: On 3/21/96, the vaccinee received his 1st injection of Engerix-B (lot ENG1814A4). The vaccinee alleged that "During the weeks and months following vaccination, (he) developed a wide array of symptoms including severe pain in the feet, ankles and legs, arthritis, erythematous rash, fatigue, headaches and chest pain. Other more severe symptoms have gradually developed and appeared over time, including neurological damage and degeneration of the liver. Plaintiff has been completely disabled due to the onset of these conditions since 1997. On or about 6/28/00, (a physician) dx'd the Plaintiff's symptoms as arising from and constituting an adverse reaction to the Hep-B vaccination he received on 3/21/96."
Sex: M
Vaccine: HEP
Symptoms: Hepatocellular damage, Neurological symptom, Pain, Rash erythematous
Clinical narrative: On 3/21/96, the vaccinee received his 1st injection of Engerix-B (lot ENG1814A4). The vaccinee alleged that "During the weeks and months following vaccination, (he) developed a wide array of symptoms including severe pain in the feet, ankles and legs, arthritis, erythematous rash, fatigue, headaches and chest pain. Other more severe symptoms have gradually developed and appeared over time, including neurological damage and degeneration of the liver. Plaintiff has been completely disabled due to the onset of these conditions since 1997. On or about 6/28/00, (a physician) dx'd the Plaintiff's symptoms as arising from and constituting an adverse reaction to the Hep-B vaccination he received on 3/21/96."
Age: 60.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Back pain, Injection site inflammation, Myalgia
Clinical narrative: A nurse reported the occurrence of joint pain in a 60 y.o. male who was vaccinated w/Hep B vaccine recombinant (Engerix-B) for prophylaxis. The subject had no relevant medical history, concurrent conditions or known drug allergies. He was described by the reporting nurse as being "very healthy." Concurrent medications included multivitamin, ginseng, fo-ti, gotu kola, red clover, dandelion, burdock root, Omega-3, vitamin E, and "natural" vitamin C. On 5/22/02, the subject received his first injection of Engerix-B (lot # not provided). An an unspecified time post-vaccination, he experienced muscle and joint aches in his shoulders, arm, neck, and back, and a burning sensation at the inject site, which felt "like a burning knife." The subject returned to the vaccine provider on 8/13/02 and described the symptoms he had experienced following the first injection of Engerix-B. The decision was made to administer the 2nd injection of Engerix-B (lot ENG5213A2; expiry 11/23/02) on 8/13/02. On 8/13/02, the subject reported to the nurse that he was experiencing a burning sensation in the joints and muscles of his arm, neck, shoulder, and back. As of 10/14/02, the outcomes of the events were unknown.
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: A pharmacist reported the inability of an adult female to respond to the third injection of Hep B vaccine recombinant (Engerix-B). Medical history, concurrent conditions, and concomitant medications were not provided. Approximately in 1998,the subject received her third injection of Engerix-B and reported that she "may have not responded." The subject stated that her titer was measured 6 to 12 months after the completion of the series (results not provided).
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: A medical assistant reported the occurrence of an inject site reaction in a 12 y.o. male who was inadvertently vaccinated with only 0.1 mL of Hep B vaccine recombinant (Engerix-B) for prophylaxis. The subject had no relevant medical history. Concurrent medications included paracetamol with codeine (Tylenol #3). On 8/26/02, the subject received his first injection (lot ENG5352A2; expiry, 2/11/04) of Engerix-B. The medical assistant reported that she intended to administer 1 mL of Engerix-B. However, when she drew back on the syringe, she found that there was a "very large air bubble in the syringe". As a result, the subject only received approximately 0.1 mL of Engerix-B. After cleaning the arm post-immunization, she noticed that the subject had experienced an inject site reaction characterized by warmth and redness. Medical attention was required at the physician's office. The Engerix-B immunization series was discontinued.
Age: 84.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This report describes an 86 y.o. female subject who tested positive for Hep B surface antigen after receiving Hep B vaccine recombinant (Engerix-B) for prophylaxis. The subject's medical history and concurrent conditions were unknown. Concurrent medications included atorvastatin calcium (Lipitor), aspirin, lisinopril, digoxin, metoprolol succinate (Toprol XL), "Nephplex Rx", ciprofloxacin hydrochloride (Cipro), intravenous cefazolin, intravenous gentamicin, and intravenous ceftazidime. On 8/14/02, the subject received two 20 mcg intramuscular injections to provide the recommended 40 mcg dose of Engerix-B. On 8/19/02, she was found to be Hep B surface antigen positive. The subject was kept in isolation. Hep B surface antigen titers measured on 8/23/02 and 8/26/02 were both negative and in-center isolation was discontinued. The reporter stated that the event was possibly due to Engerix-B administration. It was reported that the subject was "off dialysis". On follow-up, the reporter stated that the event was not serious and that the subject was not hospitalized. She was kept isolated from other dialysis patients while at the outpatient dialysis center. Therefore, this report has been reclassified as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This report was received from a pharmacist and described an adult of unspecified gender over the age of 50 years who did not respond to the Hep B vaccine recombinant (Engerix-B) immunization series. Medical history, concurrent conditions, and concurrent meditations were not provided. On unspecified dates, the subject received three injections of Engerix-B. Sometime after the injections, the reporter indicated that the subject had "not converted". Comment: The reporter indicated that another adult experienced this event, but was unable to identify the subject.