chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Headache, Loss of consciousness, Pruritus, Pyrexia
Clinical narrative: This case was reported by a nurse and described the occurrence of fever in a 26 year old male pt who received hep B vaccine recombinant (Engerix B) for prophylaxis. The pt had no relevant medical history, concurrent conditions, or concurrent medications. He reported that he developed a fever of 103 deg F and passed out following receipt of influenza virus vaccine. On 6/24/03 at 7:30, the pt received Engerix B (373B6). On 6/24/03 at 8:30, one hour post immunization, the pt telephoned the nurse and reported that he had a fever of 101.6 deg F and was experiencing itching and hives. He stated that he also felt dizzy and had a headache. At that time, he "realized" that he had received the hep B immunization series in 2002 "without any problems." The pt was treated with 50mg of oral Benadryl. The pt then began to shake. As of 12:50 on 6/24/03, the hives had resolved, but the other events persisted. The nurse considered the events were probably related to vaccination with Engerix B.
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Tremor, Urticaria
Clinical narrative: This case was reported by a nurse and described the occurrence of fever in a 26 year old male pt who received hep B vaccine recombinant (Engerix B) for prophylaxis. The pt had no relevant medical history, concurrent conditions, or concurrent medications. He reported that he developed a fever of 103 deg F and passed out following receipt of influenza virus vaccine. On 6/24/03 at 7:30, the pt received Engerix B (373B6). On 6/24/03 at 8:30, one hour post immunization, the pt telephoned the nurse and reported that he had a fever of 101.6 deg F and was experiencing itching and hives. He stated that he also felt dizzy and had a headache. At that time, he "realized" that he had received the hep B immunization series in 2002 "without any problems." The pt was treated with 50mg of oral Benadryl. The pt then began to shake. As of 12:50 on 6/24/03, the hives had resolved, but the other events persisted. The nurse considered the events were probably related to vaccination with Engerix B.
Age: 51.0
Sex: M
Vaccine: HEP
Symptoms: Fatigue
Clinical narrative: This case was reported by a nurse and described the occurrence of increased lack of energy and fatigue in a 51 year old male pt who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  The pt's medical history included chronic hepatitis B, fatigue, and lack of energy.  Concurrent medications were not reported.  On an unspecified date in December 2002, the subject received his first dose of Engerix-B.  He also received injections of Engerix-B on unspecified dates in April 2003 and May 2003.  The pt presented to his physician on an unspecified date with complaints of increased fatigue and increased lack of energy.  He reported that he did not feel rested when he awakened from sleep.  He reported that the events began after December 2002, but before April 2003.  The events persisted as of 06/30/03.  The reporting nurse considered the events to be unlikely related to vaccination with Engerix-B and "most likely due to progression of his disease or to depression."
Age: 15.0
Sex: M
Vaccine: HEP
Symptoms: Skin burning sensation
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site pain in a 15 year old male pt who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  On 03/30/03, the pt received his second injection of Engerix-B (Lot # ENG5266C9). While injecting the vaccine, the nurse noted that it was leaking.  She did not state where the leak occurred, but she stated that it did not occur where the needle was placed on the syringe.  She noticed that some of the vaccine ran down the pt's arm. She knew that he received some of the vaccine, because the pt stated that he felt burning during the injection. The burning resolved that day. The nurse considered the injection site burning was probably related to vaccination with Engerix-B.
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described an adult male who did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series. The pt's medical history, concurrent conditions, and concurrent medications were not reported.  On unspecified dates, the pt received three injections of Engerix-B.  The pt inadvertently received the pediatric dosage for all three injections.  At an unspecified time after the third injection, the pt was "found to be non-responsive" to the vaccine.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Upper respiratory tract infection
Clinical narrative: This case was reported by a physician's assistant and described the occurrence of shortness of breath in a 19 year old female who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  The pt's medical history included "mild" asthma since childhood that was "generally triggered by hot weather", and tobacco use (less than one pack of cigarettes per day). Concurrent medications and unspecified oral contraceptive, salbutamol inhaler used as needed, and cetirizine (Zyrtec).  On 07/01/03, the subject received her first dose of Engerix-B.  On 07/002/03, the pt presented to the physician with "upper respiratory symptoms" and shortness of breath, which had begun 10 hours post-immunization.  The symptoms were unresponsive to salbutamol metered-dose inhaler. Other treatment was not specified.  The reporter stated that the pt did not return to the physician's office, so the events had "likely resolved".  The reporter considered the events to be possibly related to Engerix-B or to a "concurrent URI (upper respiratory infection)/mild asthma flare."
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Neck pain, Pain
Clinical narrative: This case was reported by a nurse practitioner and described the occurrence of neck and shoulder pain in a 38 year old female who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  The pt's past medical history included arthritis and an unspecified form of lupus. Concurrent medications included valdecoxib (Bextra).  On 07/02/03 at 07:00 the pt received her first injection of Engerix-B (Lot # ENG5373B6) in the right arm. Nine hours post-immunization at 16:00, the pt experienced pain in her neck and left shoulder.  The pt told the nurse that she thought the events were related to vaccination with Engerix-B.
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Vaccine positive rechallenge
Clinical narrative: A nurse reported that an adult female pt 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 received a series of injections of hepatitis B vaccine (manufacturer unknown) on unspecified dates.  It was subsequently determined that the pt "failed to respond" to the vaccine.  On unspecified dates, the pt received three injections of Engerix-B.  It was subsequently determined that the pt "failed to respond" to Engerix-B.
Age: 25.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis
Clinical narrative: This case was reported by a physician and described the occurrence of chronic hepatitis B infection in a 25 year old male pt who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  On an unspecified date, the pt received an injection of Engerix-B. Three days post-immunization, a test for hepatitis B surface antigen was positive.  The pt was referred to the reporter.  Subsequent serologies were positive for hepatitis B core antigen and hepatitis B epsilon antigen. Testing for hepatitis B DNA by polymerase chain reaction was also positive.  The physician made a diagnosis of "hepatitis B (chronic) prior to vaccine administration".  The physician considered the events to be unrelated to vaccination with Engerix-B.  The Engerix-B immunization series was discontinued.
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: This case was reported by a pharmacist and described the occurrence of hives in an adult female who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  On an unspecified date, the pt received an injection of Engerix-B.  AT an unknown time post-immunization, the pt experienced hives. The event resolved after an unspecified period of time.
Age: 62.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Asthenia, Diarrhoea, Headache, Influenza like illness
Clinical narrative: This case was reported by a nurse and described the occurrence of flu-like symptoms in a 62 year old female pt who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. The vaccine provider submitted this report directly to the CDC.  The pt's medical history included allergies to sulfa-containing medications and quinidine. There were no concurrent medications. On 06/13/03, the pt received the 1st dose of Engerix-B and had no adverse event.  On 07/14/03 the pt received the 2nd dose of Engerix-B (Lot # ENG5376A2).  On 07/15/03, 24 hours post-immunization, the pt felt weak and experienced achy joints.  On 07/16/03, she developed eye redness and a headache.  On 07/19/03, the pt developed nausea, vomiting, and diarrhea. The reporter made a diagnosis of flu-like symptoms.  On 07/20/03, the pt was "able to keep crackers down".  The events resolved on 07/21/03; however, the pt was unable to work that day. The reporter considered the events were possibly related to vaccination with Engerix-B.
Age: 62.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Vomiting
Clinical narrative: This case was reported by a nurse and described the occurrence of flu-like symptoms in a 62 year old female pt who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. The vaccine provider submitted this report directly to the CDC.  The pt's medical history included allergies to sulfa-containing medications and quinidine. There were no concurrent medications. On 06/13/03, the pt received the 1st dose of Engerix-B and had no adverse event.  On 07/14/03 the pt received the 2nd dose of Engerix-B (Lot # ENG5376A2).  On 07/15/03, 24 hours post-immunization, the pt felt weak and experienced achy joints.  On 07/16/03, she developed eye redness and a headache.  On 07/19/03, the pt developed nausea, vomiting, and diarrhea. The reporter made a diagnosis of flu-like symptoms.  On 07/20/03, the pt was "able to keep crackers down".  The events resolved on 07/21/03; however, the pt was unable to work that day. The reporter considered the events were possibly related to vaccination with Engerix-B.
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described an adult male who did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series.  On unspecified dates, the pt received four doses of hepatitis B vaccine (manufacturer unknown)>  the pt received an injection of Engerix-B in 10/02 for his fifth dose. An unspecified titer performed in 2003 revealed that the pt "has not seroconverted".
Age: 31.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: This case was reported by a health professional and described a 31 year old male who 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 received injections of Engerix-B on 08/23/01 (Lot # ENG5235A4), 09/25/01 (Lot # ENG5239A4) and 05/07/2002 (Lot # ENG5242A4).  On 04/23/03, a hepatitis B surface antibody titer measured less than 2.0.
Age: 50.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: This case was reported by health professional and described a 50 year old male who did not respond to the hep B vaccine recombinant (Engerix B) immunization series. The pt's medical history, concurrent conditions, and concurrent medications were not reported. The pt received injections of Engerix B on 8/24/01 (5239A4), 9/25/01 (5239A4) and 5/7/02 (5242A4). On 4/23/03, a hep B surface antibody titer measured less than 2.0.
Age: 42.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: This case was reported by a health professional and described a 42 year old male who did not respond to the hep B vaccine recombinant (Engerix B) immunization series. The pt's medical history, concurrent conditions, and concurrent medications were not reported. The pt received injections of Engerix B on 5/23/01 (5235A4), 9/25/01 (5239A4) and 5/7/02 (5242A4). On 4/24/03, a hep B surface antibody titer measured less than 2.0.
Age: 39.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: This case was reported by a health professional and described a 39 year old male who had a decreased response to the hep B vaccine recombinant (Engerix B) immunization series. The pt's medical history, concurrent conditions, and concurrent medications were not reported. The pt received injections of Engerix B on 9/25/01 (5239A4), 10/22/01 (5235A4), and 4/1/02 (5242A2). On 5/20/03, a hep B surface antibody titer measured 5.4.
Age: 16.0
Sex: M
Vaccine: HEP
Symptoms: Eye disorder, Facial palsy, Hemiparesis
Clinical narrative: This case was reported by a physician and described the occurrence of Bell's palsy in a 16 year old male pt who received hep B vaccine recombinant (Engerix B) for prophylaxis. On 7/22/03 the pt received the 2nd dose of Engerix B. One day post-immunization, on 7/23/03, the pt presented to the physician with weakness in the left side of the face, including difficulty opening and closing the left eye and the inability to flex the left side of his forehead. He also had a "drooping smile." The physician made a diagnosis of Bell's palsy. The most recent info was received on 8/20/03. The Bell's palsy had improved by 8/14/03. The reporting physician considered the events were possibly related to vaccination with Engerix B, and the immunization series was discontinued. The reporter considered the Bell's palsy to be nonserious; however, the event is considered to be medically serious by manufacturer (OMIC).
Age: 41.0
Sex: M
Vaccine: HEP
Symptoms: Neck pain, Shoulder pain
Clinical narrative: This case was reported by a nurse practitioner and described the occurrence of neck and shoulder pain in a 41 year old male who received hep B vaccine recombinant (Engerix B) for prophylaxis. The pt received his first injection of Engerix B (5373B6) on an unspecified date. On 7/03/03, an unspecified time post-immunization, he reported pain in his neck and shoulder. He stated that he "cannot attribute the pain in any activity."
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: This case was reported by a health professional and described the occurrence of an injection site reaction in a 30 year old female who was vaccinated with hep B vaccine recombinant (Engerix B) for prophylaxis. On 7/24/03, the pt received the second dose of Engerix B (5371A4). On 7/25/03, one day post-immunization, she developed an injection site welt that was raised, hot, tender and that itched. The pt was seen by the physician.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Injection site warmth, Pruritus
Clinical narrative: This case was reported by a health professional and described the occurrence of an injection site reaction in a 30 year old female who was vaccinated with hep B vaccine recombinant (Engerix B) for prophylaxis. On 7/24/03, the pt received the second dose of Engerix B (5371A4). On 7/25/03, one day post-immunization, she developed an injection site welt that was raised, hot, tender and that itched. The pt was seen by the physician.
Age: 20.0
Sex: U
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: This case was reported by a health professional and described the occurrence of fever in a 20 year old pt who received hep B vaccine recombinant (Engerix B) for prophylaxis. The pt's medical history, concurrent conditions, and concurrent medications were not reported. On 7/24/03, the pt received the first dose of Engerix B (5371A4). In the afternoon or evening of 7/24/03, the pt developed a fever. She was febrile when seen by the physician on 7/25/03.
Age: 45.0
Sex: U
Vaccine: HEP
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site reaction, Pruritus
Clinical narrative: This case was reported by a health professional and described an injection site reaction in a 45 year old pt who received hep B vaccine recombinatn (Engerix B) for prophylaxis. On 7/24/03, the pt received an injection of Engerix B (5371A4). On 7/25/03, one day post-immunization, the pt developed an injection site reaction characterized by a "red, itchy spot." The pt was seen by the physician. The reporter stated that the injection site reaction was "perhaps from the bandage."
Age: 18.0
Sex: M
Vaccine: HEP, MEN, HEP, MEN
Symptoms: Dizziness, Medication error
Clinical narrative: This case was reported by a nurse and described lightheadedness in an 18 year old male who received hep B vaccine recombinant (Engerix B) for prophylaxis. The pt had no known drug allergies. There were no concurrent medications. In June 2003 and on 7/22/03, the pt received injections of Engerix B without adverse event. On 7/29/03, the pt returned to receive an injection of Menomune. The nurse did not realize that the second injection of Engerix B had been administered one week earlier, and administered a third dose. The pt's mother telephoned the physician to report that the pt experienced lightheadedness four to five hrs post-immunization. The lightheadedness resolved by the morning of 7/30/03.
Age: 18.0
Sex: M
Vaccine: HEP, MEN, HEP, MEN
Symptoms: Dizziness
Clinical narrative: This case was reported by a nurse and described lightheadedness in an 18 year old male who received hep B vaccine recombinant (Engerix B) for prophylaxis. The pt had no known drug allergies. There were no concurrent medications. In June 2003 and on 7/22/03, the pt received injections of Engerix B without adverse event. On 7/29/03, the pt returned to receive an injection of Menomune. The nurse did not realize that the second injection of Engerix B had been administered one week earlier, and administered a third dose. The pt's mother telephoned the physician to report that the pt experienced lightheadedness four to five hrs post-immunization. The lightheadedness resolved by the morning of 7/30/03.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: This case was reported by a nurse described the occurrence of vomiting in an 11 year old female who received hep B vaccine recombinant (Engerix B) for prophylaxis. On 5/19/03, the pt received her second injection of Engerix B. Two days later, on 5/21/03, the pt experienced nausea, vomiting, and diarrhea. The events resolved on 5/22/03. The reporting nurse considered the events were possibly related to vaccination with Engerix B.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Hypersensitivity, Pruritus, Urticaria
Clinical narrative: This case was reported by a physician and described the occurrence of a possible allergic reaction in a 35 year old female pt who received hep B vaccine recombinant (Engerix B) for prophylaxis. The pt's past medical history included latex sensitivity. In early June 2003 the pt received the 1st dose of Engerix B that had been packaged in a single-dose vial. "A few hours" post-immunization, the pt experienced redness and itching of the arm, which then generalized. She also developed generalized hives. The vaccine provider considered these events to represent a possible allergic reaction to Engerix B. The vaccine provider did not prescribe any treatment; however, he did not know if the pt self-medicated. The hives resolved "after several hours." The redness and itching resolved after an unspecified period of time.
Age: 13.0
Sex: M
Vaccine: HEP, TD, HEP, TD
Symptoms: Headache, Pain, Pyrexia, Vomiting
Clinical narrative: This case was reported by a nurse and described the occurrence of fever in a 13 year old male pt who received hep B vaccine recombinant (Engerix B) for prophylaxis. On 8/5/03 the pt received the 1st dose of Engeirx B in the right arm. The pt also received an injection of tetanus and diphtheria toxoids in the left arm. Later that day, at an unspecified time post-immunization, the pt experienced fever of 103 deg F, pain in both arms, vomiting, and headache. The pt's mother treated the events with Motrin. The events resolved on 8/8/03. The nurse considered the events were possibly related to vaccination with Engerix B and tetanus and diphtheria toxoids. The Engerix B immunization series was discontinued.
Age: 13.0
Sex: M
Vaccine: HEP, TD, HEP, TD
Symptoms: Headache, Injection site reaction, Pain, Pyrexia, Vomiting
Clinical narrative: This case was reported by a nurse and described the occurrence of fever in a 13 year old male pt who received hep B vaccine recombinant (Engerix B) for prophylaxis. On 8/5/03 the pt received the 1st dose of Engeirx B in the right arm. The pt also received an injection of tetanus and diphtheria toxoids in the left arm. Later that day, at an unspecified time post-immunization, the pt experienced fever of 103 deg F, pain in both arms, vomiting, and headache. The pt's mother treated the events with Motrin. The events resolved on 8/8/03. The nurse considered the events were possibly related to vaccination with Engerix B and tetanus and diphtheria toxoids. The Engerix B immunization series was discontinued.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Urticaria
Clinical narrative: This case was reported by a health professional and described the occurrence of chronic idiopathic urticaria in a 19 year old female pt who received hep B vaccine recombinant (Engerix B) for prophylaxis. The pt's medical history included polycystic ovary syndrome. Concurrent medications include dmetformin and Yasmin. On 4/8/03 the pt received the 1st dose of Engerix B. On 4/13/03, five days post-immunization, the pt developed hives and rash. The pt was seen by the reporter, who made the diagnosis of chronic idiopathic urticaria. Metformin and Yasmin therapies were discontinued; the rash and hives persisted. On 8/18/03 the reporter stated, "So far, the hives have not resolved but antihistamine and Zantac will control them." The reporter stated that the events could have been associated with polycystic ovary syndrome. Yasmin therapy, or Metfromin therapy. However, he also stated that the events were possibly related to vaccination with Engerix B. The Engerix B immunization series was delayed until at least December 2003.
Age: 14.0
Sex: M
Vaccine: HEP
Symptoms: Ageusia, Convulsion, Discomfort, Tremor
Clinical narrative: This report describes the occurrence of a possible seizure in a 14 year old male who received hep 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 mother stated that in 1999, the pt received his first dose of hep B vaccine. Reportedly, at an unspecified time post-immunization, he experienced "a more severe reaction than the reaction to the second dose." In the afternoon of 8/5/03, the subject received his second dose of Engerix B. According to the mother, the pt experienced "shaking and uncomfortable, strong" and loss of taste approximately 45 mins post-immunization. She stated that a "possible seizure" occurred during the evening of 8/5/03. Reportedly, the pt was taken to the local ER, where he was treated with unspecified IV medication "because he had not eaten all day" and Atarax. The mother stated that the pt was monitored and then sent home on the same day. Reportedly, the pt was "emotionally and socially drained after this event and does not have any memory of the experience." The seizure resolved on 8/5/03. The shaking, uncomfortable feeling, loss of taste, and feeling of being emotionally and socially drained resolved after approximately one week. The Engerix B immunization series was discontinued. Possible seizure is considered to be medically serious by manufacturer (OMIC).
Sex: U
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site soreness in a pt who received hep B vaccine recombinant (Engerix B) for prophylaxis. On an unspecified date, the pt received an injection of Engerix B (544A4; not a valid lot number). At an unspecified time post-immunization, the pt experienced injection site soreness. The event resolved after an unspecified period of time. Additional info was received from the vaccine provider on 9/12/03. The nurse who administered the vaccine stated that approximately 50 staff members at the facility had been immunized. The nurse wrote, "Most, if not all of the staff here who receive Engerix B vaccine experience a level of discomfort ranging from mild to severe injection site pain during infusing of the vaccine into the muscle with the majority of the staff experiencing moderate to severe pain upon infusion." The nurse declined to provide information on the individual staff members.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: This case was reported by a physician and described the occurrence of injection site pain in a 42 year old female pt who receiving hep B vaccine recombinant (Engerix B) for prophylaxis. On 8/13/03, the pt received an injection of Engerix B (5386A2). Immediately post-immunization, she experienced "severe stinging and pain" at the injection site which resolved after two minutes. The reporting physician suspected an "unusual or abnormal vaccine lot"; however, the physician also reported that patients who previously received this lot of vaccine did not experience pain.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: This case was reported by a physician and described the occurrence of injection site pain in a 39 year old female pt who received hep B vaccine recombinant (Engerix B) for prophylaxis. On 8/13/03, the pt received an injection of Engerix B (5386A2). Immediately post-immunization, she experienced "severe stinging and pain" at the injection site, which resolved after two minutes. The reporting physician suspected an "unusual or abnormal vaccine lot"; however, the physician also reported that patients who previously received this lot of vaccine did not experience pain.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: This case was reported by a physician and described the occurrence of injection site pain in an 18 year old female pt who received hep B vaccine recombinant (Engerix B) for prophylaxis. On 8/13/03, the pt received inadvertently received the adult dosage of Engerix B (5386A2). Immediately post-immunization, she experienced "severe stinging and pain" at the injection site, which resolved after two minutes. The reporting physician suspected an "unusual or abnormal vaccine lot"; however, the physician also reported that patients who previously received this lot of vaccine did not experience pain.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Joint swelling, Pruritus, Rash
Clinical narrative: This case was reported by a medical assistant and described the occurrence of joint swelling in a 52 year old female pt who received hep B vaccine recombinant (Engerix B) for prophylaxis. The pt had traveled " in early August 2003" and returned with a pruritic rash. The rash had resolved by 8/5/03. On 8/6/03, the pt received the 1st dose of Engerix B (538A2; not a valid lot number). On 8/9/03, three days post-immunization, the pt experienced swelling in the joints of her hands and ankles and a re-occurrence of the pruritic rash. The pt treated the rash with Benadryl. The pt was seen by the physician on 8/13/03 and 8/15/03. No treatment was given. As of 8/15/03, the events had improved. The Engerix B immunization series was discontinued.
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal, Medication error
Clinical narrative: This case was reported by a nurse and described a female pt in her mid-20s who did not respond to the hep B vaccine recombinant (Engerix B) immunization series. The pt received three injections of Engerix B on unspecified dates. The reporter stated that the pt had "received at least two, maybe three, pediatric doses of Engerix B." In August 2003, one to two months after the third dose of vaccine, unspecified titers were "negative."
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: This case was reported by a physician and described a 22 day old male pt who tested positive for hepatitis B core IgG and hep B surface antigen after receiving hep B vaccine recombinant (Engerix B) for prophylaxis. The infant's mother tested positive for hep B core antibody, which was "thought to be a result of a resolved hepatitis B infection." The infant's medical history and concurrent conditions were not reported. There were no concurrent medications. On 7/7/03, the pt received the 1st dose of Engerix B. On 7/8/13, 12 hrs post-immunization, tests for hep B core IgG and hep B surface antigen were positive. Repeat tests for hep B core IgG and hep B surface antigen performed on 7/16/03 were positive. The most recent info was received on 10/14/03. Serologies for hep B core IgG and hep B surface antigen were again negative on 8/29/03. The physician considered the infant's positive test for hep B core IgG to be possibly related to maternal transfer of the immunoglobulin and the positive test for hep B surface antigen to be related to administration of Engerix B only 12 hrs prior to the blood draw.
Age: 14.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: This case was reported by a nurse and described a 14 year old female pt who tested positive for hep B surface antigen after receiving hep B vaccine for prophylaxis. On 7/5/00 the pt received the 3rd dose of hep B vaccine. In August 2003, a test for hep B surface antigen was "positive." On 9/11/03, the nurse reported that "the initial test was a false positive. Upon retesting pt for a whole hepatitis series, all tests were negative except for surface antigen."
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: This case was reported by a physician and described a 6 week old male pt who tested positive for hep B surface antigen after receiving hep B vaccine recombinant (Engerix B) for prophylaxis. The pt's past medical history included prematurity. The pt had received a blood transfusion. The pt's mother tested negative for hep B surface antigen. On 8/15/03 the pt received the 1st dose of Engerix B. Three days post-immunization, on 8/18/03, the pt tested positive for hep B surface antigen. On 8/25/03, testing for hep B surface antigen was "indeterminate." Testing for hep B core antigen was negative. On 10/31/03, the physician reported that lab work for persistent direct hyperbilirubinaemia was performed on 8/18/03, three days post-immunization with hep B vaccine recombinant (Engerix B), and was therefore positive for hep B surface antigen and was unrelated to the use of hep B vaccine recombinant (Engerix B). No adverse effect was reported.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Herpes simplex, Hypersensitivity, Pharyngolaryngeal pain
Clinical narrative: This case described the occurrence of an allergic reaction in a 52 year old female pt who received hep B vaccine for prophylaxis. This report was received from the pt, who is an emergency medical technician. The pt's past medical history included allergy to thimerosal. The pt stated that she had unspecified adverse experiences following receipt of previous, unspecified immunizations. On an unspecified date in 2002 the pt received the 1st dose of hep B vaccine. At an unknown time post-immunization, the pt experienced an allergic reaction characterized by mouth sores and a sore throat. The pt was seen by a physician. The events resolved after an unspecified period of time. The hep B immunization series was discontinued.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: This case was reported by a nurse and described a 26 year old female who did not respond to the hep B vaccine recombinant (Engerix B) immunization series. On 6/18/02, the pt received her first injection of Engerix B. On 7/18/02, the pt received her second injection of Engerix B. On 12/17/02, the pt received her third injection of Engerix B. Lot numbers for this series were not provided. On 8/25/03, serology for hep B surface antigen was "negative." The reporter considered this to represent a lack of response to immunization. On 9/11/03, the pt received a booster injection of Engerix B.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: This case was reported by a nurse and described a 50 year old female pt who did not respond to the hep B vaccine recombinant (Engerix B) immunization series. On 12/2/02, the pt received her first dose of Engerix B (5351A4). On 1/2/03, the pt received the second dose of Engerix B (5351A4). On 6/3/03, the pt received the third dose of Engerix B (5389A4). On 7/31/03, a hep B surface antibody titer was "negative." The nurse considered the events to be related to vaccination with Engerix B. The reporter stated that "many" patients did not seroconvert following receipt of three doses of Engerix B. However, only one other pt is presently identifiable; please see report A0427422A.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Arthritis, Condition aggravated, Oedema peripheral
Clinical narrative: This case was reported by a nurse and described the occurrence of worsening arthritis of the left knee in a 50 year old female pt who received hep B vaccine recombinant (Engerix B) for prophylaxis. The pt's medical history included arthritis of the left knee diagnosed following knee surgery in 1999 for a torn meniscus, and diabetes mellitus. No pt history of gout, Crohn's disease, or Lyme disease. The pt had no family history of rheumatoid arthritis or lupus. .The pt reported that she "has problems with vaccines" and "got a heart virus after the swine flu shot." She noted that she had received hep A vaccine without any problems. Concurrent medications were not reported. On 6/24/03, the pt received the first dose of Engerix B. Prior to receiving the 20mcg dose, the pt underwent a "two step" skin test for an unspecified reason. The pt reported that, within one day of immunization, she experienced worsening of arthritis in her left knee characterized by swelling and pain. The worsening of arthritis resolved after approximately 12 days, and she did not seek medical attention. The worsening of arthritis resolved after approximately six days. All joint complains resolved before the pt was evaluated by a physician. The nurse considered both episodes of worsening arthritis were possibly related to vaccination with Engerix B.
Sex: F
Vaccine: HEP, TTOX, UNK
Symptoms: Laboratory test abnormal
Clinical narrative: This report was received from a pharmacist and described an adult female (the reporter's spouse) who tested positive for hep B surface antigen after receiving hep B vaccine recombinant (Engerix B) for prophylaxis. On an unspecified date in approximately June 2003, the pt received the first dose of Engerix B. The pt also received an injection of tetanus toxoid and "one other" unidentified vaccine. Approximately three months post-immunization, in September 2003, the pt tested positive for hep b surface antigen. The reporter considered the positive test to be possibly related to Engerix B administration.
Age: 41.0
Sex: M
Vaccine: HEP
Symptoms: Laboratory test abnormal, Medication error
Clinical narrative: This case was reported by a physician and described a 41 year old male who did not respond to the hep B vaccine recombinant (Engerix B) immunization series. The pt had no relevant medical history, concurrent conditions, or concurrent medications. The pt received injections of hep B vaccine on 2/22/01, 3/20/01, and 8/17/01. An unspecified "titer" measured < 2 on 3/31/02. The pt began another series of injections with Engerix B (5363C6) on 6/13/03. An unspecified "titer" measured < 2 on 7/11/03. On 7/22/03, the pt received the second dose of Engerix B. An unspecified "titer" measured < 2 on 8/19/03. The pt received the third dose of Engerix B (5363C6) on 8/21/03; this dose was administered two months after the first dose, rather than the recommended interval of six months. On 9/15/03, 25 days post-immunization, an unspecified "titer" measured 7.
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Headache, Influenza like illness, Pyrexia
Clinical narrative: This case was reported by a nurse and described the occurrence of headache in a female pt in her thirties who received hep B vaccine recombinant (Engerix B) injection for prophylaxis. On 9/15/03 the pt received the 1st dose of Engerix B. On that date, she also received a tuberculin skin test. approximately four hrs post-immunization, on 9/15/03, the pt experienced headache, fatigue, fever and flu-like symptoms. The fatigue, fever and headache resolved the next day. The outcome of flu-like symptoms is unknown.
Age: 22.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: This case was reported by a nurse and described a 21 year old male pt who did not respond to the hep B vaccine recombinant (Engerix B) immunization series. On 1/6/03, the pt received his first dose of Engerix B (5351A4). On 2/7/03, the pt received the second dose of Engerix B (5351A4). On 7/15/03, the pt received the third dose of Engerix B (5444A4). On 9/2/03, a hepatitis B surface antibody titer was "negative." The nurse considered the events to be related to vaccination to Engerix B. The reporter stated that "many" patients did not seroconvert  following receipt of three doses of Engerix B. However, only one other pt is presently identifiable; please see report A0424946A.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Asthenia, Chills, Headache, Nausea
Clinical narrative: A nurse reported the occurrence of right upper quadrant pain in a 24 year old female who received hep B vaccine recombinant (Engerix B) for prophylaxis. The pt had no relevant medical history, concurrent conditions or concurrent medications. On 8/13/03, the subject received her first injection of Engerix B. Approximately two weeks post-immunization, in Aug 2003, the pt developed abdominal pain. The event resolved approximately two weeks later. The second dose of Engerix B was administered on 9/15/03. Approximately eight days following the second dose, on 9/23/03, the pt developed right upper quadrant pain, abdominal pain, nausea, headache, chills, weakness and a fever of 100.4 deg F. At unspecified ultrasound and urinalysis were negative; complete blood count and liver function tests were normal. The events were resolved approximately two weeks later on 10/6/03. The series of Engerix B was discontinued. The nurse reported the events as "serious because the pt was incapacitated for two weeks." The nurse considered the events to be possibly related to Engerix B administration.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Pyrexia
Clinical narrative: A nurse reported the occurrence of right upper quadrant pain in a 24 year old female who received hep B vaccine recombinant (Engerix B) for prophylaxis. The pt had no relevant medical history, concurrent conditions or concurrent medications. On 8/13/03, the subject received her first injection of Engerix B. Approximately two weeks post-immunization, in Aug 2003, the pt developed abdominal pain. The event resolved approximately two weeks later. The second dose of Engerix B was administered on 9/15/03. Approximately eight days following the second dose, on 9/23/03, the pt developed right upper quadrant pain, abdominal pain, nausea, headache, chills, weakness and a fever of 100.4 deg F. At unspecified ultrasound and urinalysis were negative; complete blood count and liver function tests were normal. The events were resolved approximately two weeks later on 10/6/03. The series of Engerix B was discontinued. The nurse reported the events as "serious because the pt was incapacitated for two weeks." The nurse considered the events to be possibly related to Engerix B administration.
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Injection site hypersensitivity, Injection site induration, Injection site oedema, Injection site reaction, Injection site warmth
Clinical narrative: This case was reported by a nurse and described the occurrence of an injection site reaction in a 32 year old male who received hep B vaccine recombinant (Engerix B) for prophylaxis. On 9/29/03, the pt received the second dose of Engerix B (5444A4). Later that day, at an unspecified time post-immunization, the pt developed an injection site reaction characterized by swelling, warmth, redness, and induration that was approximately 1.5 inches from the injection site. The pt was seen by the physician. The outcome of events is unknown. Per follow up report events resolved on Sept 29 2003.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Headache, Influenza like illness, Pyrexia
Clinical narrative: This case was reported by a nurse and described the occurrence of headache in a female pt in her twenties who received hepatitis B vaccine recombinant (Engerix-B) injection for prophylaxis.  On 09/22/03 the pt received the 1st dose of Engerix-B.  On that date, she also received a tuberculin skin test.  Approximately four hours post-immunization, on 09/22/03, the pt experienced headache, fatigue, fever and flu-like symptoms.  The events resolved by 09/24/03.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Arthralgia, Diarrhoea, Fatigue, Hypersensitivity
Clinical narrative: This case was reported by a consumer and described the occurrence of joint pain in a 29 year old female who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  This report was received from the pt and has not been verified by a physician or other healthcare professional.  The pt's medical history included allergy to PCN.  Concurrent medications included fluoxetine, clonazepam and verapamil.  On 09/24/03, the pt received the first dose of Engerix-B (Lot # ENG5390A4).  The following day, the pt experienced joint pain, joint swelling, jaws locked shut, irritability, fever, extreme fatigue, muscle cramping, stiff neck, abdominal cramps, and diarrhea.  The pt also was unable to move for three days.  She sought medical attention at a MD's office and was treated with ibuprofen and acetaminophen.  The diarrhea resolved and the stiff neck, irritability, fever, fatigue, muscle cramping and abdominal cramps improved by 10/07/03. The locked jaws, and joint pain and swelling were unresolved as of 10/07/03.   As per follow up report: The patient ws diagnosed with a hypersensitivity reaction to hepatitis B vaccine. 10/30/2003, blood test results were within normal limits with teh exception of cholesterol. On 11/18/2003, the joint pain and swelling continued and the patient was referred to a rheumatologist. The physician noted that the Engerix B immunization series had been discontinued.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Hypokinesia, Irritability, Muscle spasms, Musculoskeletal stiffness, Oedema
Clinical narrative: This case was reported by a consumer and described the occurrence of joint pain in a 29 year old female who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  This report was received from the pt and has not been verified by a physician or other healthcare professional.  The pt's medical history included allergy to PCN.  Concurrent medications included fluoxetine, clonazepam and verapamil.  On 09/24/03, the pt received the first dose of Engerix-B (Lot # ENG5390A4).  The following day, the pt experienced joint pain, joint swelling, jaws locked shut, irritability, fever, extreme fatigue, muscle cramping, stiff neck, abdominal cramps, and diarrhea.  The pt also was unable to move for three days.  She sought medical attention at a MD's office and was treated with ibuprofen and acetaminophen.  The diarrhea resolved and the stiff neck, irritability, fever, fatigue, muscle cramping and abdominal cramps improved by 10/07/03. The locked jaws, and joint pain and swelling were unresolved as of 10/07/03.   As per follow up report: The patient ws diagnosed with a hypersensitivity reaction to hepatitis B vaccine. 10/30/2003, blood test results were within normal limits with teh exception of cholesterol. On 11/18/2003, the joint pain and swelling continued and the patient was referred to a rheumatologist. The physician noted that the Engerix B immunization series had been discontinued.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of joint pain in a 29 year old female who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  This report was received from the pt and has not been verified by a physician or other healthcare professional.  The pt's medical history included allergy to PCN.  Concurrent medications included fluoxetine, clonazepam and verapamil.  On 09/24/03, the pt received the first dose of Engerix-B (Lot # ENG5390A4).  The following day, the pt experienced joint pain, joint swelling, jaws locked shut, irritability, fever, extreme fatigue, muscle cramping, stiff neck, abdominal cramps, and diarrhea.  The pt also was unable to move for three days.  She sought medical attention at a MD's office and was treated with ibuprofen and acetaminophen.  The diarrhea resolved and the stiff neck, irritability, fever, fatigue, muscle cramping and abdominal cramps improved by 10/07/03. The locked jaws, and joint pain and swelling were unresolved as of 10/07/03.   As per follow up report: The patient ws diagnosed with a hypersensitivity reaction to hepatitis B vaccine. 10/30/2003, blood test results were within normal limits with teh exception of cholesterol. On 11/18/2003, the joint pain and swelling continued and the patient was referred to a rheumatologist. The physician noted that the Engerix B immunization series had been discontinued.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Anaemia, Blood fibrinogen increased, Fatigue, Headache, Laboratory test abnormal
Clinical narrative: This case was reported by a physician and described the occurrence of anemia in a 48 year old female pt who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  The pt's medical history was notable for good general health prior to the onset of these events.  The pt received injections of Engerix-B on 12/05/02, 01/14/03 and 06/03/03.  At an unspecified time after the third dose, the pt developed a fever of unknown origin, throbbing headaches, poor sleep, and fatigue.  She was seen by a physician.  Laboratory investigations revealed "mild" anemia, elevated white blood cell count, elevated sedimentation rate, elevated platelets, fibrinogen, and C-reactive protein.  The outcome of the events was unknown. The physician noted that the events jeopardized the patient. The events resolved on 23 September 2003. The physician considered the events to be possibly related to vaccination with Engerix-B