chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal, Unevaluable event
Clinical narrative: A physician reported the inability of a 40-year-old female to respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series. The pt's medical history, concurrent conditions and concurrent medications were unknown. The physician did not believe that the pt was immunocompromised. On unspecified dates, the pt received a series of hepatitis B vaccine (brand unknown) and was found to be nonresponder after the 3rd injection. An additional series of Engerix-B was given "recently" at 0, 1, and 6 months. The 6th injection was given in Oct 2002. A titer measured "a little" after one month after the 6th injection was "negative".
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Medication error, Thermal burn
Clinical narrative: A physician reported the occurrence of an injection site reaction in a 37-year-old female who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. The pt's medical history, concurrent medical conditions or concurrent medications were not provided. On 11/13/2002 an adult female was vaccinated with 2 pediatric doses of hepatitis B vaccine recombinant (Engerix-B) (ENG5356A2) rather than an adult injection. Two days later, on 11/15/2002, the pt experienced redness and burning distal to the injection site. This was the pt's 1st injection of hepatitis B vaccine recombinant.
Age: 15.0
Sex: U
Vaccine: HEP
Symptoms: Fibromyalgia
Clinical narrative: A physician reported the occurrence of symptoms of fibromyalgia in a 15-year-old pt of unspecified gender who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. The pt's medical history, concurrent medical conditions or concurrent medications were not provided. Approx 6 years ago, the pt was vaccinated hepatitis B vaccine recombinant series (manufacturer unknown). On unspecified dates, the pt was vaccinated with a 2nd series of hepatitis B vaccine recombinant (Engerix-B). On an unspecified date the pt began to experience symptoms of fibromyalgia. The event is reported to persist.
Age: 9.0
Sex: M
Vaccine: HEP
Symptoms: Injection site erythema, Injection site inflammation, Injection site reaction, Pruritus
Clinical narrative: This report describes the occurrence of an injection site reaction in a 9-year-old male who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. This report was received from the pt's mother and has not been verified by a physician or other health care professional. Concurrent conditions and concurrent medications were not reported. The pt reportedly had no allergies. The pt's brother reportedly experienced swollen liver, elevated bilirubin, fatigue, muscle pain and joint pain following receipt of his 1st injection of Engerix-B. On 09/17/2002, the pt reportedly received his 1st injection of Engerix-B (lot ENG5313A2). The mother stated that "after twenty-four hours", on 09/18/2002, her son experienced an injection site reaction characterized by redness, inflammation, itching and tightness. The pt was seen by the physician, who prescribed a "topical steroid cream" and amoxicillin. The events resolved on an unspecified date. The Engerix-B immunization series was discontinued. This report has been linked to report A0387553A due to same family.
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Anorexia, Arthralgia, Fatigue, Hepatomegaly, Injection site erythema
Clinical narrative: This report describes the occurrence of swollen liver in a 13-year-old male who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. This report was received from the pt's mother and has not been verified by a physician or other health care professional. The pt reportedly had no allergies. Concurrent conditions and medications were not reported. The pt's brother experienced an injection site reaction characterized by swelling, redness, inflammation, itching and tightness after receiving his 1st Engerix-B injection. On 09/17/2002, the pt reportedly received his 1st injection of Engerix-B (lot ENG5313A2). "Within a week" he experienced fatigue. Reportedly, he also experienced muscle pain, joint pain, general malaise and loss of appetite. His physician "ran a multitude of tests to rule out other possible causes (of the events)." Reportedly, he only found that the pt's liver was slightly enlarged and that the pt's bilirubin was slightly elevated. As of 11/22/2002, the events reportedly persisted. The Engerix-B immunization series was discontinued. This report has been linked to report A0387550A due to same family.
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Injection site inflammation, Injection site reaction, Injection site swelling, Malaise, Myalgia
Clinical narrative: This report describes the occurrence of swollen liver in a 13-year-old male who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. This report was received from the pt's mother and has not been verified by a physician or other health care professional. The pt reportedly had no allergies. Concurrent conditions and medications were not reported. The pt's brother experienced an injection site reaction characterized by swelling, redness, inflammation, itching and tightness after receiving his 1st Engerix-B injection. On 09/17/2002, the pt reportedly received his 1st injection of Engerix-B (lot ENG5313A2). "Within a week" he experienced fatigue. Reportedly, he also experienced muscle pain, joint pain, general malaise and loss of appetite. His physician "ran a multitude of tests to rule out other possible causes (of the events)." Reportedly, he only found that the pt's liver was slightly enlarged and that the pt's bilirubin was slightly elevated. As of 11/22/2002, the events reportedly persisted. The Engerix-B immunization series was discontinued. This report has been linked to report A0387550A due to same family.
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Pruritus
Clinical narrative: This report describes the occurrence of swollen liver in a 13-year-old male who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. This report was received from the pt's mother and has not been verified by a physician or other health care professional. The pt reportedly had no allergies. Concurrent conditions and medications were not reported. The pt's brother experienced an injection site reaction characterized by swelling, redness, inflammation, itching and tightness after receiving his 1st Engerix-B injection. On 09/17/2002, the pt reportedly received his 1st injection of Engerix-B (lot ENG5313A2). "Within a week" he experienced fatigue. Reportedly, he also experienced muscle pain, joint pain, general malaise and loss of appetite. His physician "ran a multitude of tests to rule out other possible causes (of the events)." Reportedly, he only found that the pt's liver was slightly enlarged and that the pt's bilirubin was slightly elevated. As of 11/22/2002, the events reportedly persisted. The Engerix-B immunization series was discontinued. This report has been linked to report A0387550A due to same family.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Fatigue, Headache, Injection site rash
Clinical narrative: A nurse reported the occurrence of an injection site rash in 20-year-old female who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. The pt had no relevant medical history, concurrent medical conditions or concurrent medications. There were no known drug allergies. On an unspecified date, the pt received an injection of hepatitis B vaccine recombinant (Engerix-B) 20 mcg in the left arm (lot #ENG5299A4). On 11/18/2002, the pt developed chills. On 11/21/2002, the pt experienced fatigue, and developed an injection site rash. On an unspecified date, the pt experienced a headache. All events were experienced post-vaccination. The injection site rash resolved on 11/22/2002 while all the other events resolved by 11/25/2002. The reporter considered the events to be related to Engerix-B administration.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Unevaluable event, Unintended pregnancy
Clinical narrative: A physician assistant reported the occurrence of a 31-year-old female who failed to respond after vaccination with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. The pt's medical history, concurrent medical conditions and concurrent medications were not specified. In March 2002 the pt received her 5th injection of hepatitis B vaccine recombinant (Engerix-B). Approx 8 months after the 5th injection, the pt had a "negative titer test". The pt had been vaccinated with the 1st 2 injections in January and Feb 1999. The series was discontinued after the 2 injections because the pt became pregnant. The series was repeated in Sept 2001 after the pt's pregnancy.
Age: 0.01
Sex: M
Vaccine: HEP
Symptoms: Urticaria, Vaccine positive rechallenge
Clinical narrative: This report describes the occurrence of hives in a 1 day old male who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  This report was received from the pt's mother and has not been verified by a physician or other healthcare professional.  The subject had no relevant medical history.  Concurrent medical conditions and concurrent medications were not specified.  On 11/06/2002, the subject received his first injection of hepatitis B vaccine recombinant (Engerix-B). Twelve hours later, the subject developed hives.  The hives resolved two days later.  The reporter stated the subject had developed hives after each subsequent injection of Engerix-B and diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) (see report number A0388124A).  The subject was seen by a dermatologist who allegedly reported the hives may be a reaction to the vaccines.  Comment: This report has been linked to report A0388124A due to the same pt and same reporter.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: A nurse reported the occurrence of failing to seroconvert in an adult pt who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. The pt's medical history, concurrent medical conditions and concurrent medications were not provided. The pt received an unspecified injection of hepatitis B vaccine recombinant (Engerix-B). After an unspecified amount of time, the pt failed to seroconvert. Comment: The reporter indicated that there were 6 adult pts who failed to seroconvert. However, they are not presently identifiable.
Age: 62.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Hepatitis, Laboratory test abnormal
Clinical narrative: A physician reported a 62-year-old female was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis and subsequently tested positive for the hepatitis B surface antigen. The pt's medical history and concurrent conditions were not reported. Concurrent medications included estrogen, testosterone, vitamins and Gingko. The pt experienced no adverse events following previous immunizations. On 10/21/2002, the pt received her 1st injection of Engerix-B (lot #ENG5354A2) consisting of 2 injections of 10 mcg to provide the adult 20 mcg injection. On 10/22/2002, she attempted to donate blood and was told she tested positive for the hepatitis B surface antigen. On that date, she tested negative for hepatitis B core antibody, and hepatitis C antibodies. On 12/30/2002, she tested non-reactive for hepatitis B core IgM, hepatitis B surface antibody and hepatitis B surface antigen. The reporting physician indicated that the pt will receive the remaining Engerix-B immunizations.
Age: 35.0
Sex: M
Vaccine: HEP
Symptoms: Hepatic enzyme abnormal, Rash
Clinical narrative: This report describes the occurrence of elevated liver enzymes in a 36-year-old male who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. This report was received by the pt and has not been verified by a physician or heath care professional. The pt's medical history, concurrent medical conditions and concurrent medications were not specified. The pt had no adverse events after previous vaccinations. In May 2001, the pt received his 2nd injection of hepatitis B vaccine recombinant (Engerix-B). During that same month, the pt developed elevated liver enzymes and a rash. Prior to vaccination, the pt's liver tests showed levels of 27 whereas, after vaccination, the levels were at 48, 43, and 49. The rash developed on the pt's wrists, arms, hands and upper torso. The pt took cetirizine hydrochloride (Zyrtec) to treat the rash. The rash had resolved by 11/18/2002. The liver enzyme elevation persisted at the time of this report.
Sex: M
Vaccine: HEP
Symptoms: Alanine aminotransferase increased
Clinical narrative: A nurse reported the occurrence of elevated alanine aminotransferase in a "young" adult 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. The pt did not drink alcohol. On unspecified dates "over a year ago", the pt received a series of Engerix-B injections. "Recently", the pt went for a routine physical and his alanine aminotransferase (ALT) was 77 IU (reference range unspecified). The reporting nurse did not think that the elevated ALT was related to Engerix-B administration "since Engerix-B was given over one year ago." As of 12/11/2002, the elevated ALT persisted.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Tremor
Clinical narrative: A physician reported the occurrence of shaking of both hands in an 18-year-old male who was vaccinated with hepatitis B vaccine recombinant (Engerix-B for prophylaxis. The pt's relevant medical history, concurrent conditions and concurrent medications were unknown. On 12/16/2002, the pt received his 1st injection of Engerix-B. "Immediately" afterward, the pt experienced shaking in both hands. He was seen in the physician's office and was then referred to a neurologist. The reporting physician stated that the event was unrelated to Engerix-B administration. As of 12/17/2002, the event persisted. As of 02/03/2003, the outcome of the event was unknown.
Age: 37.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: A nurse reported that a 37-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 not reported. The pt experienced no adverse events following previous immunizations. The pt received injections of Engerix-B on 01/17/2002 (lot ENG2994C6), an unspecified date (lot ENG3231C6) and 07/25/2002 (lot ENG3231C6). Subsequently, an unspecified time post-immunization, it was determined that he had not responded to immunization. On 11/13/2002, the pt received his 4th injection of Engerix-B (lot ENG3231C6) without adverse event. On 12/11/2002, the pt received his 5th injection of Engerix-B (lot ENG3231C6) one day after the labelled expiration date. No adverse events occurred. On 01/29/2003 the pt received his 6th injection of Engerix-B (lot ENG5303A4) without adverse event.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Chest pain, Discomfort, Dysphonia, Face oedema, Hypersensitivity
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 prophalyxis. The pt's medical history included unspecified liver dysfunction. Concurrent conditions and medications were not reported. On 12/02/2002, the pt received her 1st injection of Engerix-B (lot ENG5305B6). On that date, she also received a tuberculin Mantoux test. On 12/07/2002, 5 days post-immunization, she experienced 5 episodes of being awakened in the night with "extreme" itching on the palms of her hands that then spread to her pubic area, head, arms and thighs. There was no rash. She also noted a thickening of the anterior portion of her tongue and swelling of her lips that affected her ability to speak. She also experienced tightening of her neck, heaviness of her mid upper chest, "severe" discomfort, "copious" amounts of frothy sputum and hoarseness. She was seen by her physician, who made a diagnosis of allergic reaction. She was treated with unspecified medications. The allergic reaction persisted as of 12/18/2002. The Engerix-B immunization series was discontinued. The allergic reaction in this report is considered GSK medically serious.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Musculoskeletal stiffness, Pruritus, Tongue disorder
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 prophalyxis. The pt's medical history included unspecified liver dysfunction. Concurrent conditions and medications were not reported. On 12/02/2002, the pt received her 1st injection of Engerix-B (lot ENG5305B6). On that date, she also received a tuberculin Mantoux test. On 12/07/2002, 5 days post-immunization, she experienced 5 episodes of being awakened in the night with "extreme" itching on the palms of her hands that then spread to her pubic area, head, arms and thighs. There was no rash. She also noted a thickening of the anterior portion of her tongue and swelling of her lips that affected her ability to speak. She also experienced tightening of her neck, heaviness of her mid upper chest, "severe" discomfort, "copious" amounts of frothy sputum and hoarseness. She was seen by her physician, who made a diagnosis of allergic reaction. She was treated with unspecified medications. The allergic reaction persisted as of 12/18/2002. The Engerix-B immunization series was discontinued. The allergic reaction in this report is considered GSK medically serious.
Age: 16.0
Sex: M
Vaccine: HEP
Symptoms: Medication error, Nausea
Clinical narrative: A physician reported the occurrence of nausea in a 16-year-old male who inadvertently received an adult injection of hepatitis B vaccine recombinant (Engerix-B). The pt's medical history, concurrent conditions and concurrent medications were not reported. On 10/09/2002, the pt inadvertently received his 1st adult injection of Engerix-B. On 10/10/2002 he experienced nausea, which resolved the same day. The reporting physician stated that the nausea was possibly related to Engerix-B administration.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Malaise, Pharyngolaryngeal pain
Clinical narrative: A nurse reported the occurrence of a sore throat in a 20-year-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 unknown. The reporting nurse stated that on 11/26/2002, the pt received her 1st Engerix-B injection. On 12/02/2002, the pt's mother called the physician's office to report that the pt was experiencing a sore throat and was "rundown". As of 12/20/2002, the outcomes of the events were unknown.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Periorbital oedema, Rash, Urticaria
Clinical narrative: A nurse reported the occurrence of swelling around the eyes in a 21 year old female who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  The subject's relevant medical history, concurrent conditions and concurrent medications were not provided.  Follow-up information revealed that the hepatitis B vaccine recombinant (Engerix-B) injection was the first vaccine the subject had ever received.  The subject's parents had refused all childhood immunizations.  On 11/05/02, the subject received the first injection of hepatitis B vaccine recombinant (Engerix-B) (Lot # ENG5229B9).  On 11/11/2002, the subject experienced swelling around her eyes and hives and rash on her legs.  The subject "denied exposure to possible allergic substances (tomatoes, peanuts, fish etc.)" Subject was seen by physician who prescribed loratadine (Claritin).  By the time of the initial report, 12/27/02, the events had resolved.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: A physician reported via manufacturer the inability of a 50 year old female to respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series.  The subject's relevant medical history, concurrent conditions, and concurrent medications were not reported.  On unspecified dates, the subject received a series of Engerix-B injections.  Subsequently, she did not seroconvert.  As of 12/20/02, the outcome of the event was unknown.
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: A physician reported via manufacturer the occurrence of a decreased therapeutic response in a 55 year old male who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  The subject's relevant medical history, concurrent conditions, and concurrent medications were not reported.  The reporting physician stated that on 12/23/01, the subject was exposed to "blood borne pathogens and received a three-injection series of Engerix-B vaccine.  On 10/30/02, his titer (NOS) was less than 2."
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: A nurse reported the occurrence of a 52 year old female who did not respond to a series of hepatitis B recombinant (Engerix-B) for prophylaxis.  The subject had no relevant medical history or concurrent medications specified.  The subject had a current unspecified condition, which required dialysis.  On an unspecified date, the subject completed a four injection series of hepatitis B vaccine recombinant (Engerix-B).  On 01/09/03, an unspecified titer was drawn which resulted in a negative result.  Comment: This report has been linked to report A0392069A due to the same reporter.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: A nurse reported the occurrence of a 50 year old female who did not respond to a series of hepatitis B recombinant (Engerix-B) for prophylaxis.  The subject had no relevant medical history or concurrent medications specified.  The subject had a current unspecified condition, which required dialysis.  On an unspecified date, the subject completed a four injection series of hepatitis B vaccine recombinant (Engerix-B).  On 01/09/03, an unspecified titer was drawn which resulted in a negative result.  Comment: This report has been linked to report A0392068A due to the same reporter.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Headache, Injection site pain, Laboratory test abnormal, Vaccine positive rechallenge
Clinical narrative: A nurse reported the occurrence of throbbing in the arm of a 44 year old female who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  The subject's medical history included no known drug allergies and there were no concurrent medications or concurrent conditions specified.  The subject denied tobacco use and used alcohol socially.  The subject was administered hepatitis vaccine (unknown manufacturer) in the early 1990's.  On 12/06/2002, the subject received the first injection of her second series of hepatitis B recombinant (Engerix-B)(Lot # ENG5272A2).  The subject was administered 20mcg (contents of two pediatric 10 mcg vials).  The subject reported an injection site reaction manifested by injection site pain described as burning and stinging which caused her arm to feel as though it was throbbing and felt like it was on fire.  This feeling traveled up to her neck and side of her face.  The subject also reported having a headache.  The nurse reported that the subject experienced the same adverse reaction when she received the vaccine years ago.  On 12/08/02, the injection site reaction, injection site pain and headache had resolved.  The nurse had reported probable causality between the adverse events and the injection.  On follow up, it was also reported that the subject had an unspecified hepatitis B titer drawn on an unspecified date and that the "titer did not detect immunity."
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: An employee heath nurse reported the occurrence of a 35 year old female subject who did not respond to a series of hepatitis B vaccine for prophylaxis.  The subject's relevant medical history, concurrent conditions and concurrent medications were not specified.  On unspecified date, the subject completed a three injection series of hepatitis B vaccine (unknown manufacturer).  an unspecified titer was drawn with a negative result.  A fourth injection of hepatitis B vaccine (unknown manufacturer) (date not specified) was administered.  A second unspecified titer was drawn again with a negative result.
Age: 44.0
Sex: M
Vaccine: HEP
Symptoms: Cough, Drug administration error, Injection site pain, Nasal congestion
Clinical narrative: A consumer reported the occurrence of congestion in a 44 year old adult male who was vaccinated with hepatitis B recombinant vaccine (Engerix-B) for prophylaxis.  This report was received from the subject's wife and has not been confirmed by a physician or any other health care professional.  The subject did not have any relevant medical history or concurrent conditions.  Concurrent medications were unspecified.  On 10/07/2002, the subject received the third injection of hepatitis B vaccine recombinant (LOT # ENG5207A2) three days past the labeled expiration date.  The subject's wife reported that the injection was a "pediatric vaccine" and "may not have gotten the recommended dose." However, in follow up it was reported that the subject received the adult injection 20mcg/1.0ml.  Additionally, on this date, the subject experienced soreness at the injection site, "more than with previous shots" which resolved.  At the end of 2002, the subject's wife reported that the subject developed congestion and coughing.  On an unspecified date, the subject was seen by his health care provider and prescribed antibiotic therapy (name and dosage unspecified).  The reporter stated that the congestion and coughing had improved.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: A medical co-ordinator reported the occurrence of adult subjects (gender not specified) who did not respond to a series of hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  The subject's relevant medical histories, concurrent conditions and concurrent medications were not provided.  The subjects received the first injection of the series on 02/06/2001 (Lots: ENG5167A2, ENG3232A4 or ENG3360A4), the second injection was on 03/14/2001 (Lot # ENG3382A4) and the third injection was administered on 08/22/2001.  On 12/13/2002, a titer was drawn.  The reporter stated that "so far, they have seven low-responders ranging from 2 to 9 mIU/mL hep B titers."
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Anxiety, Paraesthesia
Clinical narrative: A nurse reported the occurrence of an anxiety attack in a 29-year-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 provided. On 05/28/2002, the pt received an injection of Engerix-B (lot ENG5186C6) into an unspecified arm. The pt stated that her arm began to tingle "immediately". The reporting nurse attributed this to an anxiety attack, because the vaccine injection was "very dramatic for [the pt]." The pt was treated with diphenhydramine (Benadryl). The reporting nurse contacted the pt that evening, and was told that the arm tingling had resolved. The reporting nurse considered the anxiety attack to be unrelated to Engerix-B administration. However, the Engerix-B immunization series was discontinued.
Sex: M
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: A nurse reported the occurrence of injection site pain in an adult male subject of unspecified age who was administered the hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  The subject's relevant medical history, concurrent conditions and concurrent medications were not provided.  Six months ago, in approximately 07/02, the subject received his third injection of Engerix-B.  The subject's complaint of injection site pain persists.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: This report describes the inability of an adult pt of unspecified gender to respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series. The pt's relevant medical history, concurrent conditions, and concurrent medications were unknown. Reportedly, the pt received a 3-injection series of Engerix-B. It was reported that 1 to 2 months after the 3rd injection of Engerix-B, a titer revealed that the pt "did not seroconvert."
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: A physician's assistant reported the occurrence of pain at the injection site in a 29 year old female who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  The subject's medical history included "mild", persistent, left arm pain following receipt of her second injection of hepatitis B vaccine (Recombivax-HB, Merck) in October 2001.  The pain was exacerbated by palpation and "specified movement of the arm".  Concurrent conditions and concurrent medications were unknown.  In May 2002, the subject received an injection of Engerix-B (Lot # ENG5216A2) administered into the left arm.  Subsequently, the subject experienced increased pain at the injection site.  The subject was seen in the clinic.  The pain was not located in the shoulder joint and the subject had full range of motion.  However, she reported difficulty reaching into the back seat of her car.  The pain persisted as of 04/14/2003.  The reporter considered the injection site pain to be possibly related to "scar tissue from injection".
Age: 30.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: A physician reported the occurrence of a male subject approximately 30 years of age who did not respond to two different series of hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.   The subject's relevant medical history or concurrent conditions were not provided.  Concurrent medications and allergies were not specified.  On an unspecified date, the subject completed the second series of hepatitis B vaccine recombinant (Engerix-B).  On an unspecified date, the physician reported that the subject "had not responded."  The physician reported that the titers (NOS) were drawn at the correct times.
Sex: U
Vaccine: HEP
Symptoms: Muscle twitching
Clinical narrative: A nurse reported the occurrence of the development of "muscle tics" in an age and sex unspecified child who was administered hepatitis B vaccine recombinant (Engerix-B). The pt's relevant medical history, concurrent medications and concurrent conditions were unspecified. On 08/26/2002, the pt received the 1st injection of hepatitis B vaccine recombinant and received the 2nd injection on 10/29/2002. The nurse reported that the pt "developed muscle tics after 2 vaccinations with Engerix-B," however reported the onset of the event as "mid September 2002", after receipt of the 1st injection.
Age: 43.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Back pain, Chills, Pyrexia, Sinusitis
Clinical narrative: A nurse practitioner reported the occurrence of fever in a 43 year old male who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  The subject was originally from Turkey.  He stated that he had no relevant medical history, concurrent conditions, or concurrent medications.  However, the reporter was "not convinced that he answered medical history questions correctly."  On 01/21/03, the subject received his first injection of Engerix-B (Lot # ENG5285C6).  Approximately 6 hours post-immunization, he began to experience chills, fever, joint pain and back pain.  He was seen by the reporter on 01/23/03.  There were no warm or swollen joints.  Physical findings were consistent with sinusitis.  White blood cell count was 13,600 cells/cu mm.  A nasal swab culture was negative for influenza.  The reporter prescribed a 10 day course of clarithromycin.  The most recent information, received on 02/27/03, indicated that the events resolved on 01/23/03.  The reporter considered the events to be possibly related to Engerix-B administration or to possible sinusitis.  The Engerix-B immunization series was discontinued.
Age: 43.0
Sex: M
Vaccine: HEP
Symptoms: White blood cell count increased
Clinical narrative: A nurse practitioner reported the occurrence of fever in a 43 year old male who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  The subject was originally from Turkey.  He stated that he had no relevant medical history, concurrent conditions, or concurrent medications.  However, the reporter was "not convinced that he answered medical history questions correctly."  On 01/21/03, the subject received his first injection of Engerix-B (Lot # ENG5285C6).  Approximately 6 hours post-immunization, he began to experience chills, fever, joint pain and back pain.  He was seen by the reporter on 01/23/03.  There were no warm or swollen joints.  Physical findings were consistent with sinusitis.  White blood cell count was 13,600 cells/cu mm.  A nasal swab culture was negative for influenza.  The reporter prescribed a 10 day course of clarithromycin.  The most recent information, received on 02/27/03, indicated that the events resolved on 01/23/03.  The reporter considered the events to be possibly related to Engerix-B administration or to possible sinusitis.  The Engerix-B immunization series was discontinued.
Age: 48.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: A nurse reported the occurrence of a 48 year old male who did not respond to two series of hep B vaccine recombinant (Engerix B) for prophylaxis. The subject had no relevant medical history, concurrent conditions or concurrent medications specified. The subject had received a three injection series of Engerix B in 1997 (dates unspecified). A hep B surface antibody titer measured on 1/4/02 was <2MIU/mL (a measurement >10 MIU/mL indicating immunity). On 1/18/02, the subject received his fourth injection of Engerix B. Hep B surface antibody titers on 2/7/02 and 3/21/02 were negative (a positive value indicating immunity); hep B surface antibody quantitative taken on 3/21/02 measured 0.0MIU/mL (>10MIU/mL indicating immunity). On 6/19/02, the subject received his fifth injection of Engerix B. A hep B surface antibody titer drawn on 6/27/02 was negative (positive indicating immunity). On 8/19/02, the subject received his sixth injection of Engerix B. A hep B surface antibody titer measured on 1/22/03 was negative (positive indicating immunity).
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: A nurse reported that a 27 year old female did not respond to the hep B vaccine recombinant immunization series. The subject had no relevant medical history or concurrent conditions. There were no concurrent medications. The subject received injections of Engerix B 5/7/02, 6/6/02 and on 11/6/02. A titer, measured on 1/17/03, was negative.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: A nurse reported that a 27 year old female did not respond to the hep B vaccine recombinant (Engerix B) immunization series. The subject had no relevant medical history or concurrent conditions. There were no concurrent medications. The subject was administered her first series of Engerix B injections on 12/7/01, 1/13/02 and on 6/3/02. A titer, measured one to two months after completion of the series, was negative. The subject then received three additional injections. The dates were unspecified for the first and second injections; the third injection was administered on 1/22/03. A second titer, measured on an unspecified date, was negative.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Crying, Dyspnoea, Injection site hypersensitivity, Injection site pain, Pruritus
Clinical narrative: A nurse reported the occurrence of injection site pain in a 39 year old female who was vaccinated with hep B vaccine recombinant (Engerix B) for prophylaxis. The subject's relevant medical history included allergy to latex gloves, Medrol, amoxicillin, and Carbocaine with epinephrine. The subject had no adverse experiences following previous immunizations. There were no concurrent medications. On 12/30/02, the subject received her first injection of Engerix B (5351A). Later that day, she began to experience pain at the injection site and  itching. The subject reported that these events resolved after three weeks. She did not seek medical attention. The subject received her second injection of Engerix B (5377A4) in the ER on 2/4/03. Within 10 minutes, she experienced site pain, itching, shortness of breath, and crying. Oxygen saturation was 99 to 100% during this time. The subject was treated with 25mg Benadryl. On 2/5/03, the subject returned to the ER, stating that she continued to experience injection site pain, itching, and SOB. The reporting nurse stated that she thought the events could be "psychological." The most recent info, received on 3/3/03, indicated that the injection site pain had improved by 2/25/03. The outcomes of the itching, SOB, and crying were not reported.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Loss of consciousness, Pain
Clinical narrative: A nurse reported that a 28 year old female passed out after being vaccinated with hep B vaccine recombinant (Engerix B) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. The subject had no adverse experiences following previous immunizations. On an unspecified date, the subject received her second injection of Engerix B (5362A2). The nurse reported that the injection caused the subject to "scream out in pain" and she "passed out." The events resolved after an unspecified period of time. The reporting nurse considered the vents to be possibly related to Engerix B administration.
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: A nurse reported the occurrence of an age unspecified female who did not respond to a hep B vaccine series (unk manuf) for prophylaxis. The subject had no relevant medical history, concurrent conditions or concurrent medications specified. On an unspecified date, "several years ago," the subject reported she had completed a hep B vaccine series. On an unspecified date, a titer was drawn which revealed negative antibodies. Comment: This case is considered non-reportable as an adverse event has not been reported.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: A nurse reported the occurrence of a 27 year old female who did not seroconvert after receiving three injections of hep B vaccine, one hep B vaccine recombinant and two injections of hep B vaccine. The subject's medical history, concurrent medical conditions, and concurrent medications were not provided. On 11/23/01, the subject received her first injection of Engerix B. Subsequently, the subject received two doses of hep B vaccine on 12/23/03 (1069L), and 5/23/02 (1536L). Two months following the third injection, the subject's "titer" 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. Results of the inquiry were not provided. Treatment and outcome of the events were not provided. Comment: This report has been linked to reports A0376434A and A0395496A due to the same reporter.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: A nurse reported the occurrence of a 52 year old female who did not seroconvert after receiving three injections of hep B vaccine recombinant (Engerix B). The subject's medical history, concurrent medical conditions, and concurrent medications were not provided. On 7/13/01, 8/13/01, and 1/13/02, the subject received injections of Engerix B. Two months following the third injection, the subject's "titer" 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. Results of the inquiry were not provided. Treatment and outcome of the events were not provided. Comment: This report has been linked to reports A0376434A and A0395494A due to the same reporter.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Drug administration error, Headache, Visual disturbance
Clinical narrative: A nurse reported the occurrence of a headache in a 51 year old female who was vaccinated with ehp B vaccine recombinant (Engerix B) for prophylaxis earlier than recommended. The subject had no relevant medical history and received no concomitant medications. On 1/29/03 and 2/5/03, the subject received her first and second injections of Engerix B (5377A) respectively. The second injection was received one week after the first injection. On 2/5/03, at an unspecified time post-immunization, the subject experienced a headache and saw "black spots." As of 2/10/03, the events persisted.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: A nurse reported the occurrence of injection site pain in a 50 year old female who was vaccinated with hep B vaccine recombinant (Engerix B) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. The subject had no adverse experiences following previous immunizations. On an unspecified date, the subject received her third injection of Engerix B (5362A2). The nurse reported that the injection caused the subject to complain of "severe" injection site pain. The event resolved after an unspecified period of time. The reporting nurse considered the event to be possibly related to Engerix B administration.
Sex: F
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: A nurse reported the occurrence of injection site pain in an adult female of unspecified age who was vaccinated with hep B vaccine recombinant (Engerix B) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. She had no adverse experiences following previous immunizations. On an unspecified date, the subject received her second injection of Engerix B (5362A2). The nurse reported that the injection caused the subject to "scream out in pain." The injection site pain resolved after an unspecified period of time.
Sex: F
Vaccine: HEP
Symptoms: Injection site induration, Injection site mass
Clinical narrative: A nurse reported the occurrence of an injections site lump in a female of unspecified age who was vaccinated with hep B vaccine recombinant (Engerix B) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were unknown. On 1/10/03, the subject received her first injection of Enerix B. Later that day, she developed a "hard lump: at the injection site that measured "three inches across." The lump resolved after approximately two weeks.
Age: 41.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Hepatitis, Laboratory test abnormal
Clinical narrative: A nurse reported that a 41 year old male tested positive for hep B core antigen being vaccinated with hep B vaccine recombinant (Engerix B) for prophylaxis. The subject had no relevant medical history, concurrent conditions, or concurrent medications. On 8/27/02, the subject received his first injection of Engerix B (5358A2). He received his second injection of Engerix B (5353B2) on 9/27/02. On 10/10/02, the subject attempted to donate blood. He was told that he could not donate blood because he was hep B core antigen positive; serology for hep B surface antigen was negative. The subject received his third injection of Engerix B (5355A2) on 2/27/03. Serology for hep B surface antibody was non-reactive on 4/7/03. Serologies for hep B surface antigen and hep B core antibody were non-reactive on 4/11/03.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Cough
Clinical narrative: This report described the occurrence of a chronic cough in a 58 year old female who was vaccinated with hep B vaccine recombinant (Engerix B) for prophylaxis. This report was received from the subject and has not been verified by a physician or any other healthcare professional. The subject's medical history reportedly included SOB after exercising. Concurrent medications included an unspecified "stomach medicine." The subject stated that she had no adverse experiences following previous immunizations. On an unspecified date in September 2002, the subject received her first injection of Engerix B. She received her second injection on an unspecified date in October 2002. She reported that she started to cough "since beginning the Engerix B series." She was examined by a physician, who did not find a cause for the cough. A chest x-ray "was negative." The subject used non-prrescription cough suppressants and "prescription therapy" without relief. She reported that the cough was only relieved by taking one-half tablet of Vicodin.
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: A nurse reported that a 45 year old male had a decreased therapeutic response to the hep B vaccine recombinant (Engerix B) immunization series. The subject's medical history, concurrent conditions, and concurrent medications were not specified. The subject received injections of Engerix B on a 0, 1 and 6 month schedule. On 2/6/03, 30 days after receiving the third injection of Engerix B, a titer was found to be below the protective level.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash erythematous, Rash macular
Clinical narrative: A nurse reported the occurrence of a macular rash in a 23 year old female who was vaccinated with hep b vaccine recombinant (Engerix B) for prophylaxis. The subject had no relevant medical history, no known drug allergies, and no concurrent medications. The subject experienced no adverse events following the first injection of Engerix B, or other previous immunizations. On 2/20/, the subject received her second injection of Engerix B (5338B6). One day later, on 2/21/03, she develo9ped an erythematous pruritic macular rash scattered "all over body" including the trunk, forearm, and legs. The subject was seen by a physician. The reporting nurse considered the events to be possibly related to Engerix B administration. As of 2/24/03, the rash persisted.
Sex: U
Vaccine: HEP
Symptoms: Influenza like illness
Clinical narrative: This report describes the occurrence of flu-like symptoms in an unidentified subject who was vaccinated with hep B vaccine recombinant (Engerix B) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On an unspecified date, the subject received an injection of Engerix B (5379A4). Subsequently, the subject experienced flu-like symptoms. The outcome of the events was unknown. Comment: The reporter indicated that 11 subjects experienced flu-like symptoms after receiving Engerix B (5379A4). However, they are not presently identifiable.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: A nurse reported the occurrence of an injection site reaction in a 25 year old female who was vaccinated with hep B vaccine recombinant (Engerix B) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were unknown. On 1/9/03, the subject received her second injection of Engerix B (5285C6). Approximately 24 hrs later, on 1/10/03, the subject experienced an injection site reaction characterized by redness and swelling the "size of a baseball." The subject was seen by the physician, who prescribed Benadryl. On an unspecified date, the event resolved.