chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Guillain-Barre syndrome
Clinical narrative: This case was reported by a pharmacist and described the occurrence of Guillain [[name]] Syndrome in a 52 year old female pt who received Engerix-B and Havrix. On 3/3/04, the pt received separate injections of Engerix-B and Havrix. Approximately 36 days, post/vax, on 4/8/04, the pt experienced Guillain [[name]] Syndrome and was hospitalized. The outcome of the event is unknown. Comment: "Guillian [[name]] Syndrome" was assessed as medically serious by Mfr.
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Palpitations
Clinical narrative: This case was reported by a nurse and described the occurrence of heart palpitations in an adult female pt who received hep B vaccine (unk manf). On an unspecified date, the pt received the first dose of hep B vaccine. At an unspecified time following the administration of hep B vaccine, the pt experienced heart palpitations and dizziness. The immunization series with hep b vaccine was discontinued. The outcome of the events is unk.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Medication error
Clinical narrative: This case was reported by a 23 yr old medical assistant who did not respond to the hep B vaccine recombinant (Engerix B) immunization series. The medical assistant reported that she received three doses of Engerix B on 07Jul03 (lot ENG5379A4), 08Aug03 (lotENG5390A4) and 09Feb04 (lot ENG5507A4). Engerix B was administered on a 0, 1 and 7 month schedule rather than the recommended schedule of 0, 1, and 6 months. On an unspecified date in May 2004, a hep B surface antibody titer indicated that the medical assistant was non-reactive.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Medication error
Clinical narrative: This case was reported by medical assistant and described a 28 yr old female pt who did not respond to the hep B vaccine recombinant (Engerix B) immunization series. The pt  received three doses of Engerix B on 07Jul03 (lot ENG5379A4), 08Aug03 (lot ENG5390A4) and 09Feb04 (lot ENG5507A4). Engerix B was administered on a 0, 1 and 7 month schedule rather than the recommended schedule of 1, 1, and 6 months. On an unspecified date in May 2004, a hep B surface antibody titer indicated that the pt was non-reactive.
Sex: F
Vaccine: HEP, HEPA
Symptoms: Rash
Clinical narrative: This case was reported by a nurse and described the occurence of abdominal rash in a female pt who received hep B vaccine recombinant (Engerix B) plus a separate injection of hep A vaccine inactivated (Havrix). On 08Apr04, the pt received the first dose of Engerix B (lot ENG5447A6) in the right deltoid. On 08Apr04, the pt also received the first dose of Havrix (lot VHA776D6) in the left deltoid. The afternoon of the same day as the admin of Engerix B and Havrix, 08Apr04, the pt experienced abdominal rash. The event resolved approx nine days later, on 17Apr04. The nurse consideredf the abdominal rash to be related to vaccination with Engerix B and Havrix.
Sex: F
Vaccine: HEP
Symptoms: Rash pruritic, Vomiting
Clinical narrative: This case was reported by a nurse and described the occurrence of vomiting in a female pt in her early twenties who received hep B vaccine recombinant (Engerix B). On 13Apr04, the pt received the first dose of Engerix B in her right leg (lot ENG5466A4). On the same day of the admin of Engerix B, on 13Apr04, the pt experienced an itchy rash on her leg. The reporter did not state which leg was affected. The itchy rash resolved in a couple days on an unspecified date in Apr 2004. On 25May04, the pt received the second dose of Engerix B. On the same day of the admin if Engerix B, the pt experienced vomiting. The vomiting resolved in 24 hrs, on 26May04.
Age: 37.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Arthralgia, Influenza like illness, Myalgia
Clinical narrative: This case was reported by a nurse and described the occurrence of muscle pain in a 37 yr old female pt who received hep B vaccine recombinant (Engerix B). On 02Apr04, the pt received the first dose of Engerix B (lot ENG5588A4). On 02Apr04, the pt also received an injection of varicella virus vaccine (Varivax). Approx one month after the admin of Engerix B, on an unspecified date in May 2004, the pt experienced muscle pain, joint pain, and flu-like symptoms. As of 22Jun04, the outcome of the events was unk. The nurse considered the events to be unrelated to vaccination with Engerix B.
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a medical assistant and described an adult female pt who did not respond to the hep B vaccine recombinant (Engerix B) immunization series. The medical assistant reported two adult females pt's, however, no pt identifiers were provided. On unspecified dates, the pt received three doses of Engerix B (lot ENG 5379A4, lot ENG 5390A4, and lot ENG5507A4). On an unspecified date, a hep B surface antibody titer indicated that the pt was non reactive. The reporter stated that teh pt sought medical attention, however no further information was provided. Report received via manf.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: This case was reported by a nurse and described the occurrence of an injection site reaction in a 45 year old female pt who received hep B vaccine recombinant (Engerix). On 25Jun04, the pt received the first dose of Engerix B in the right arm (lot ENG5540A2). Immediately following the admin of Engerix B, on 25Jun04, the pt experienced an injection site reaction characterized as redness and swelling. The events resolved approx 40 minutes later on 25Jun04. The nurse considered the events to probably be related to vaccination with Engerix B.
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a physician to a sales rep and described an adult male pt who did not respond to immunization with Hep b vaccine (manf unk). On unspecified dates, the pt received an unspecified number of doses of hep B (manf unk). Subsequently, on an unspecified date, a hep B surface antibody titer was negative.
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described an adult female pt who did not respond to the hep B vaccine (manf unk). The pt's medical history, concurrent conditions and concurrent medications were not reported. On unspecified dates the pt received the hep B vaccine 3 dose series. On an unspecified date in 2004, approx 6 weeks after the most recent dose of hep B vaccine, a hep B surface antibody titer was non reactive.
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a pharmacy intern and described an adult male pt 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. On unspecified dates the pt received three doses of Engerix B (lot numbers not specified). On an unspecified date later, a hep B surface antibody titer was less than 10 mIU/ml (negative). The pt then received another three shot series of Engerix B (lot numbers not specified), and on an unspecified date later, a repeat hep B surface antibody titer was less than 10 m IU/ml (negative).
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described an adult female pt who did not respond to the hep b vaccine recombinant (Engerix B).  The pt's medical history, concurrent conditions and concurrent medications were not reported. On an unspecified date the pt received the third dose of Engerix B (lot ENG5446A4). On an unspecified date approx one to two months later, a hep B surface antibody titer was negative.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Medication error
Clinical narrative: This case was reported by a nurse and described a 50 yr old female pt who did not respond to immunization with hep B vaccine recombinant (Engerix B). On unspecified dates, the pt received the full series of Engerix B (dose numbers not specified). At an unspecified time following the admin of the Engerix B series, on an unspecified date in Apr 2004,  a hep B surface antibody test revealed a titer of six. On 18Jun04, the pt received a booster dose of Engerix B (lot ENG5379A4). The expiration date for this lot of Engerix B is 18May04. No adverse event occurred following the 18Jun04 booster dose.
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described an adult male pt who did not respond to the hep b vaccine recombinant (Engerix B). The pt's medical history, concurrent conditions and concurrent medications were not reported. On an unspecified date the pt received the third dose of Engerix B (lot ENG5446A4). On an unspecified date approx one to two months later, a hep B surface antibody titer was negative.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Medication error
Clinical narrative: This case was reported by a nurse and described a 36 yr old female pt who did not respond to immunization with hep B vaccine recombinant (Engerix B). The pt's medical history was notable for tobacco use. On unspecified dates, the pt received the full series of Engerix B (dose numbers not specified). At an unspecified time following the admin of the Engerix b series, on an unspecified date in Apr 2004, a hep B surface antibody test revealed a titer of zero. On 18Jun04 the pt received a booster dose of Engerix B (lot Eng5379A4). The expiration date for this lot of Engerix B is 18May04. No adverse event occurred following the 18Jun04 booster dose.
Sex: M
Vaccine: HEP
Symptoms: Hepatic enzyme abnormal, Laboratory test abnormal
Clinical narrative: This case was reported by a pharmacy student and described the occurrence of increased liver enzymes in a male pt in his thirties who received Engerix B. On an unspecified date, the pt received the second dose of Engerix B. At an unspecified time following the administration of the second dose of Engerix B, laboratory analysis revealed that the pt developed increased liver enzymes. The reporter stated that she, "was not sure if alanine or aspartate transaminase increased but the number increased from 40 to 120." The outcome of the event is unknown. Comment: Increased liver enzymes was assesses as medically serious (OMIC) by the manufacturer.
Sex: U
Vaccine: HEP
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: This case was reported by a nurse to a sales representative and described the occurrence of an injection site reaction in a pt who received Engerix B. The nurse reported that several patients experienced an injection site reaction following  the administration of Engerix B, however no patient identifiers were provided. On an unspecified date, the pt received a dose of Engerix B (dose number not specified). At an unspecified time following the administration of Engerix B, the pt experienced an injection site reaction characterized by burning and stinging. The outcome of the event is unknown. The nurse stated that she, "noticed more burning and stinging at site of injection with Engerix B compared to Recombivax."
Age: 84.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Hepatitis, Viral infection
Clinical narrative: This case was reported by a nurse and described an 84 year old female pt who tested positive for hepatitis B e antigen following the administration of Engerix B. The pt's history was notable for renal failure (cause not specified) requiring hemodialysis, diabetes mellitus (type not specified), coronary artery disease, hypertension and Parkinson's disease. On 02 July 2004, the pt received the fourth dose of Engerix B (lot ENG5589A4). The reporter stated that, "five days after receiving Engerix B, on 07 July 2004, laboratory findings indicated that the pt developed hepatitis B e antigen."  A repeat laboratory test performed on 12 July 2004 for hepatitis B e antigen was "non-reactive." The nurse considered the event to possibly be related to vaccination with Engerix B.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Hepatitis, Viral infection
Clinical narrative: This case was reported by a nurse and described a 50 year old female pt who tested positive for hepatitis B surface antigen following the administration of Engerix B. The pt's medical history was notable for renal failure (cause not specified) requiring hemodialysis, diabetes mellitus (type not specified), hypertension, tuberculosis, chronic obstructive pulmonary disease, tobacco use and cachexia. On 02 July 2004, the pt received the second dose of Engerix B (lot ENG5589A4). The reporter stated that, "five days after receiving Engerix B, on 07 July 2004, laboratory findings indicated that the pt developed hepatitis B surface antigen." A repeat laboratory test performed on 13 July 2004 for hepatitis B surface antigen was "negative." The nurse considered the event possible related to vaccination with Engerix B.
Sex: U
Vaccine: HEP
Symptoms: Liver function test abnormal
Clinical narrative: This case was reported by a consumer to a sales representative and described the occurrence of elevated liver function tests in an adult pt who received hepatitis B vaccine (manufacturer unknown). The consume is reporting for a coworker. This case has not been verified by a health care professional. On an unspecified date, the pt received the third dose of hepatitis B vaccine. At an unspecified time following the administration of the third dose of hepatitis B vaccine, the pt's liver function tests were elevated. The outcome of the event is unknown. Comment "Elevated liver function tests" was assessed as medically serious (OMIC) by the manufacturer.
Age: 52.0
Sex: M
Vaccine: HEP
Symptoms: Facial palsy
Clinical narrative: This report describes the occurrence of Bell's Palsy in a 51 year old male pt who received Engerix B for prophylaxis. This report was received from a nurse. The pt's medical history included acute renal failure (cause not reported). Concurrent medications included Procrit, heparin, PhosLo, Protonix, Reglan, hydrocodone, Citracel, Vitamin D and Lotrel. On 29 May 2004 the pt received the second dose of Engerix B in the right arm. On 15 June 2004, 17 days post-immunization, the pt developed Bell's palsy. He was not hospitalized but was referred back to his primary care physician. At time of initial reporting, the event was unresolved. This case was assessed as medically serious (OMIC) by the manufacturer.
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: The case reported by a physician and described the occurrence of generalized urticaria in a 25 year old male pt who received Engerix B. On 22 July 2004, the pt received the first dose of Engerix B in the right arm (ENG5586A2). Approximately one day following the administration of Engerix B, on 23 July 2004, the pt experienced pruritus of the hands and fingers "that developed into urticaria all over the body." There was no localized reaction at the injection site. The pt was seen at a physician's office and was treated with steroids and diphenhydramine. The events resolved on 24 July 2004.
Sex: F
Vaccine: HEP
Symptoms: Back pain, Headache
Clinical narrative: This case was reported by a pharmacist to sales representative and described the occurrence of spinal pain in adult female pt who received Engerix B. On an unspecified date, the pt received a dose of Engerix B (dose number not specified). At an unspecified time following the administration of Engerix B, on an unspecified date, the pt experienced spinal pain, back pain and a headache. The outcome of events is unknown.
Age: 14.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist and described the occurrence of rash in a 14 year old female pt who received Engerix B. On an unspecified date, the pt received a dose of Engerix B (dose number not specified). On an unspecified date following the administration of Engerix B, the pt experienced a "mosquito bite like" rash. The pharmacist "got the impression that the rash was not localized" but was not sure where the rash was located. The pt was seen at a physician's office and was treated with diphenhydramine. The event resolved on an unspecified date. The vaccination with Engerix B.
Age: 22.0
Sex: M
Vaccine: HEP, MMR, TTOX
Symptoms: Rash, Urticaria
Clinical narrative: This case was reported by a nurse and described the occurrence of whole body rash in an 11 year old male pt who Engerix B. On 16 June 2004, the pt received the first dose of Engerix B in the right arm (lot ENG5570A2). On 16 June 2004, the pt also received injections of MMR II and tetanus toxoid absorbed. At an unspecified time following the administration of Engerix B, on 16 June 2004, the pt experienced rash and hives "covering the entire body." The pt was seen in an emergency room and was treated with Benadryl. The rash and hives remained unresolved. On 19 June 2004, the pt was seen again in an emergency room and was treated with medrol. The events resolved on 30 June 2004. the immunization series with Engerix B was discontinued. The nurse considered the events to possibly be related to vaccination with Engerix B.
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: This case was reported by a nurse and described the occurrence of an unspecified illness in a female patient who received Hep-B vaccine.    The patient's medical history included developmental delay and "seizure behaviour".  On 04 AUG 2000, the patient received the first dose of Engerix_B.  On 07 SEP 2000, the patient received the second dose of Energix-B.  Approximately eight months after the second dose, on 14 MAY 2001 the patient received the third dose of Energix-B.  This is longer than the recommedended interval of five months between the second and third doses of Energix-B.  At an unspecified time following the third administration of Energix-B, on an unspecified date, the patient experienced an unspecified illness.  The illness was ongoing at the time of follow-up.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a pharmacist and described a 43 year old female patient who did not respond to the Hep-B vaccines immunization series.   On an unspecified date, the patient received the third dose of Energix-B.  Approximately two months after the third dose of Energix-B, on an unspecified date, a hepatitis B surface antibody titer indicted that the patient was "non-immune".  The reporting pharmacist considered the event to probably related to vaccination with Energix_b.  The pharmacist reported that the patient had begun the "second series" of immunization with Energix-B.
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse to a sales representative and described an adult male patient who tested positive for hepatitis B antigen after receiving Energix-B.    The patient's past medical history included renal failure (cause not specified) regarding hemodialysis.    On an unspecified date, the patient received the fourth dose of Energix-B.  Approximately one year after the administration of Engerix-B, on an unspecified date, "a hepatitis B panel was positive for hepatitis B antigen,"  The reporter was unsure if the antigen was "hepatitis B antigen or hepatitis B antigen positive"  At the time of initial reporting, it was not known if the serology had been repeated.
Age: 8.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: This case was reported by a consumer and described the occurrence of erythema multiforme in an 8 year old female patient who received hepatitis B vaccine.  The reporter is the mother of the patient.  A physician or other health care professional has not verified this report.    On an unspecified date in 1998, the patient received the first dose of hepatitis B vaccines.  Approximately one day after the administration of hepatitis B vaccine, on an unspecified date in 1998, the patient experienced erythema multiforme, joint swelling "two to three times normal size", and joint pain.  The patient was seen at a phyisician;s office and was treated with prednisone and antihistamines.  The erythema multifirme (presumably, the skin lesions) and joint swelling resolved in "eight to nine days".  The joint pain was ongoing at the time of initial reporting in AUG 2004.  The immunization series with hepatitis B vaccine was discontinued.    Comment: Erythema multiforme was assessed as medically serious by GSK.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a pharmacist and described a patient who received hep-B vaccine and tested positive for hep-b antigen.    The patient's medical history included renal failure (cause not specified) requiring hemodialysis.    On an unspecified date, the patient received a dose of Energix-B.  "A few hours" after the administration of Energix-B, a hep-b surface antigen was "positive".
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of a low grade fever in a 55 year old female patient who received hep-B vaccine (Energix-B).  The reporter is the patient.  A physician or other health care professional has not verified this report.    The patient's past medical history was notable for Iga deficiency.    On an unspecified date in 2002, the patient received the first dose of Energix-B in her arm.  Approximately one day later, the patient experienced a low-grade fever, headache, and "felt under the weather."  She was seen at a physician s office and was treated with tylenol.  The events resolved "two to three days after the vaccine" was administered.  On an unspecified date in 2002 the patient received the second dose of Energix-B in her arm.  Approximately one day later, the patient again experienced a low-grade fever, headache and "felt under the weather."  The reporter stated that the events following the second administration of Engergix-B were "milder".  The events resolved "two to three days after the vaccine"  was administered.  The immunization series with Energix-B was discontinued because the patient changed jobs.
Age: 0.16
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: This case was reported by a physician and described the occurrence of facial hives in a 2 month old female patient who received hep-B vaccine.    On 09 JUN 2004, the patient received a dose of Energix-B.  At an unspecified period of time following the vaccination the patient experienced "a few hives" on the face.  The event resolved on an unspecified date.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described an adult patient who did not respond to immunization with Hep-B.    The patient's medical history included renal failure (cause not specified) requiring hemodialysis.    On an unspecified date, the patient received a dose of Energix-B.  At an unspecified time following the administration of Energix-B on an unspecified date, a hepatitis B surface antibody titre was "less than 10".  The nurse stated that the patient "failed to seroconvert"
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Therapy non-responder. This case was reported by a nurse and described an adult female who did not respond to immunization with hepatitis B vaccine recombinant (Engerix-B). The reporter is the patient. On an unspecified date in 1992, the patient received a dose of Engerix-B. On an unspecified date in 2004, a hepatitis B surface antibody titer indicated that the patient "did not seroconvert. " Report received via manufacturer.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Therapy non-responder, incorrect dose administered. This case was reported by a nurse and described a 24-year-old female patient who did not respond to immunization to the hepatitis B vaccine recombinant. On 23 October 2003, 25 November 2003, and 06 May 2004 the patient received the first, second and third dose of Engerix-B. The patient inadvertently received the 10 mcg dose for the three doses of the Engerix-B series. The recommended dose of Engerix-B for individuals older than 19 years of age is 20 mcg. On an unspecified date in 2004, at an unspecified time following the third dose of Engerix-B, a hepatitis B surface antibody titer indicated that the patient was "not seroprotected."
Age: 54.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive
Clinical narrative: Hepatitis B surface antigen positive. This case was reported by a physician and described a 54-year-old patient who received hepatitis B vaccine recombinant (Engerix-B) and subsequently tested positive for hepatitis B surface antigen. Medical history included renal failure (cause not specified) requiring hemodialysis. On 07 January 2004, prior to immunization with Engerix-B, the patient tested negative for hepatitis B surface antigen and hepatitis B surface antibody. On 23 August 2004, the patient received the first dose of Engerix-B (Lot AHBVA077AB). Approximately two days later, on 25 August, the patient tested positive for hepatitis B surface antigen. The patient received the second dose of Engerix-B on 15 September 2004 (lot AHBVA077AB). Approximately two weeks later, on 29 September 2004, a repeat test for hepatitis B surface antigen was negative. The reporting physician considered the event to be related to vaccination with Engerix-B.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Therapy non-responder. This case was reported by a nurse and described a 36-year-old female patient who did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series. The reporter is the patient. On an unspecified date, the patient received the sixth dose of Engerix-B. On an unspecified date following the sixth dose of Engerix-B., a hepatitis B surface antibody titer indicated that the patient "did not have a positive titer." The nurse considered the event to not be related to vaccination with Engerix-B.
Sex: M
Vaccine: HEP
Symptoms: Injection site induration, Injection site rash, Injection site reaction
Clinical narrative: Injection site rash, Injection site induration, Injection site reaction. This case was reported by a physician and described the occurrence of an injection site reaction in a male neonate who received hepatitis B vaccine recombinant (Engerix-B). On an unspecified date in July 2004, the patient received the first dose of Engerix-B at birth. The physician reported that, on an unspecified date post-immunization, the infant developed an indurated rash at the injection site. The physician stated, "almost two months later, if the skin is provoked at the site where the vaccine was administered, an indurated rash appears."
Age: 8.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: This case was reported by a nurse and described an 8-year-old male patient who did not respond to immunization with hepatitis B vaccine (manufacturer unknown). On unspecified dates, "starting at birth," the patient received a series of three doses of hepatitis B vaccine (manufacturer unknown). Subsequently, on 07 September 2004, a hepatitis B surface antibody titer was negative.
Age: 51.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Therapy non-responder. Poor quality drug administered. This case was reported by a nurse and described a 51 year old male who did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series. On 19 August 2004, the patient received the third dose of Engerix-B (lot ENG5389A4). The nurse stated the expiration date for this lot of Engerix-B was 21 June 2004. On 22 September 2004, a hepatitis B surface antibody titer was "less than 3.0".
Age: 32.0
Sex: M
Vaccine: HEP
Symptoms: Hypersensitivity, Injection site erythema, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: Hypersensitivity; This case was reported by a nurse and described the occurrence of an allergic reaction in a 32-year-old male who received hepatitis B vaccine recombinant (Engerix-B). Medical history included allergies to Augmentin and amoxicillin. On 15 September 2004 the patient received the third dose of Engerix-B (lot number ENG5595A6). During the administration of the third dose of Engerix-B, the nurse stated that the "patient had commented that the injection hurt on administration as opposed to the previous two Engerix-B injections." Approximately one day later, on 16 September 2004, the patient experienced a mild fever and swelling, pain, and redness at the injection site. On 17 September 2004, the injection site redness and swelling extended "from shoulder to elbow." The patient was seen at a physician's office and was diagnosed with an allergic reaction. The patient was treated with Benadryl. The events resolved on 22 September 2004. The reporting nurse considered the events to be related to vaccination with Engerix-B.
Age: 43.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described a 43 year old male who tested positive for unspecified "hepititis B antigen" after receiving Hep-B vaccine.    On 14 SEP 2004 the patient receioved the first dose of Energix-B vaccine.  Two days later, on 16 SEP 2004, the patient tested positive for unspecified hepititis B antigen.  The outcome of the event is unknown.  The burse considered the event probably related to vacconation with Engerix-B.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Rash; This case was reported by a health professional and described the occurrence of rash in a 45-year-old female patient who hepatitis B vaccine recombinant (Engerix-B). Medical history is notable for a possible allergy to thimerosal. On unspecified dates in November 2003 and December 2003, the patient received the first and second doses of Engerix-B.  On  26 May 2004, the patient received the third dose of Engerix-B (lot ENG5582B6). At an unknown time following the third administration of Engerix-B, on an unspecified date in 2004, the patient experienced a rash. The patient was seen at a physician's office. The health professional reported that she did not know if the rash was at the injection site or a systemic reaction. The outcome of the event is unknown.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Hepatitis, Laboratory test abnormal
Clinical narrative: Hepatitis B, Hepatitis B e antigen positive, Hepatitis B antibody positive, Therapy non-responder; This case was reported by a physician and described a 49-year0old female patient who tested positive for hepatitis B following immunization with hepatitis B vaccine recombinant (Engerix-B). The patient's medical history was notable for hepatitis B exposure from "two brothers who have hepatitis B." On an unspecified date in December 2000, the patient "tested negative for hepatitis B." The patient received a series of three doses of Engerix-B on 09 January 2001, 08 February 2001 and 12 July 2001. The lot number for all three doses of Engerix-B is ENG5160D9. The reporter stated that, "A titer was not done when the series was completed." On an unspecified date in September 2004, the patient was donating blood and "tested positive for hepatitis B." She was seen at a physician's office. Laboratory analyses revealed that the antibody to hepatitis B core antigen was "non-reactive," hepatitis B surface antigen was "non-reactive," IgM antibody to hepatitis B surface antigen was "non-reactive," hepatitis Be antigen was positive, antibody to hepatitis Be antigen was positive and polymerase chain reaction by focus technology revealed 8700 copies/ml of hepatitis B virus.
Sex: U
Vaccine: HEP
Symptoms: Convulsion
Clinical narrative: This case was reported by a physician to a sales representative and described the occurrence of seizure in an adult pt who received Engerix-B. On 9/16/04, the pt received a dose of Engerix-B. On an unspecified date in 9/04, at an unspecified time following the administration of Engerix-B, the pt experienced a seizure and was hospitalized. Outcome was not reported. The reporting physician considered the event to possibly be related to vaccination with Engerix-B.
Age: 2.0
Sex: M
Vaccine: HEP
Symptoms: Diarrhoea, Nausea
Clinical narrative: This case was reported by a consumer and described the occurrence of diarrhea in a 2 year old male pt who received Engerix-B. The reporter is the mother of the pt. A physician or other health care professional has not verified this report. On an unspecified date, the pt received a dose of Engerix-B. Approx. 2 days following the administration of Engerix-B, on an unspecified date, the pt experienced diarrhea and nausea. Outcome of the events was unknown.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a healthcare professional and described a pt who did not respond to the Engerix-B immunization series. The healthcare professional reported that several pts did not respond to the immunization series with Engerix-B, however, pt identifiers were no provided. On an unspecified date, the pt received a series of 4 doses of Engerix-B. On an unspecified date, a hepatitis B surface antibody titer indicated that the pt "did not respond" to immunization with Engerix-B.
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described an adult female pt who did not respond to the Engerix-B immunization series. The nurse reported that the pt was a non-smoker and was "not older or obese". On unspecified dates, the pt received a series of 3 doses of Engerix-B. Approx. 1 month after the 3rd dose, on an unspecified date, a hepatitis B surface antibody titer indicated that the pt "did not become sero-protected".
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described an adult female pt who did not respond to Engerix-B immunization series. The nurse reported that another pt that was a smoker did not respond to immunization with Engerix-B, however, pt identifiers were not reported. The nurse reported that the pt was smoker and was "not older or obese". On unspecified dates, the pt received a series of 3 doses of Engerix-B. Approximately 1 month after the 3rd dose, on an unspecified date, a hepatitis B surface antibody titer indicated that the pt "did not become sero-protected".
Sex: F
Vaccine: HEP
Symptoms: Hepatic enzyme abnormal
Clinical narrative: This case was reported by a consumer and described the occurrence of elevated liver enzymes in an adult female pt who received hepatitis B vaccine. The reporter is the pt. A physician or other health care professional has not verified this report. On an unspecified date in 7/03, the pt received the 3rd dose of hepatitis B vaccine. Approximately 2 months after the administration of the 3rd dose of hepatitis B, on an unspecified date in 9/03, at the pt's "annual physical", a blood test revealed elevated liver enzymes. The pt reported that, on an unspecified date following the 3rd dose of hepatitis B vaccine, "an ultrasound and MRI of the liver found no abnormalities". The event was ongoing at the time of initial reporting. Comment: Elevated liver enzymes was assessed as medically serious by mfr.
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described an adult female pt who did not respond to the Engerix-B immunization series. On unspecified dates in 1986, the pt received the 1st "series" of hepatitis B vaccine. On an unspecified date in 2003, a hepatitis B surface antibody titer was "non-reactive". The pt then received a series of 3 doses of Engerix-B, with the 3rd dose administered on 7/26/04. On an unspecified date in 9/04, a hepatitis B surface antibody titer was also "non-reactive". The nurse considered the events to be probably related to vaccination with Engerix-B.
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a pharmacist and described an adult female pt who did not respond to the Engerix-B series. On unspecified dates, the pt received 3 doses of Engerix-B. On an unspecified date in 2004, approximately 30 days after the 3rd dose of Engerix-B, a hepatitis B surface antibody titer was "Negative".
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Medication error
Clinical narrative: This case was reported by a nurse and described an adult male patient who did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series.  The nurse stated there were two patients; however, no patient identifiers were provided.  The patient's medical history, concurrent conditions and concurrent medications were not reported.  On unspecified dates the patient received 3 doses of Engerix B (lot ENG5540A2).   The patient inadvertently received the pediatric dosage for all 3 injections.  On an unspecified date approximately six weeks later, a hepatitis B surface antibody titer was negative.  The nurse stated that the immunization series was to be repeated.
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described an adult male pt who did not respond to the Engerix-B immunization series. The nurse stated many adult males were immunized and that "one out of three" have not responded to the immunization series; however, no pt identifiers were provided. On unspecified dates, the pt received 3 doses of Engerix-B (lot AHBVA068AA). On an unspecified date later, a hepatitis B surface antibody titer was "negative".
Age: 28.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a pharmacist and described a 28 year old male pt who did not respond to the Engerix-B immunization series. On an unspecified date, the pt received the 3rd dose of Engerix-B (lot ENG5466A4). Approx. 2 months after the 3rd dose of Engerix-B, on an unspecified date, a hepatitis B surface antibody titer indicated that the pt was "non-immune". The reporting pharmacist considered the event to probably related to vaccination with Engerix-B. The pharmacist reported that the pt had begun the "second series" of immunization with Engerix-B.
Age: 39.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a pharmacist and described a 39 year old male pt who did not respond to the Engerix-B immunization series. The pt reported "occasional" alcohol use. On an unspecified date, the pt received the 3rd dose of Engerix-B (lot ENG35466A4). Approx. 2 months after the 3rd dose of Engerix-B on an unspecified, a hepatitis B surface antibody titer indicated that the pt was "non-immune". The reporting pharmacist reported that the pt had begun the "second series" of immunization with Engerix-B.
Age: 53.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a pharmacist and described a 53 year old male patient who did not respond to the Hep-B vaccines.    The patient's medical history included childhood asthma, depression, and seasonal allergies.  Concurrent medications were not reported.    On an unspecified date, the patient received the third dose of Energix-B.  Approximately two months after the third dose, on an unspecified date, a hep-B surface antibody titer indicated that the patient was "non-immune".  The reporting pharmacist considered the event to probably be related to vaccinations with Energix-B.  The pharmacist reported that the patient has begun the second series of Energix-B.
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described a 47 year old male patient who did not respond to the hep-B vaccine.    On 30 December 2003 and 02 FEB 2004, the patient received the first and second dose of Energix-B.  On 01 JUL 2004 the patient received the third dose.  Approximately two months after the third dose on an unspecified date in SEP 2004 a hep-B surface antibody titer was "negative".  The reporting nurse considered the event to probably be related to vaccination with Energix-B.
Age: 49.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described a 49 year old male patient who did not respond to Hep-B vaccine.   On 12 JAN 2004  and 10 FEB 2004, the patient received the first and second dose of Energix-B.  On 14 JUL 2004 the patient received the third dose of Energix-B.  On 16 SEP 2004, a Hep-B surface antibody titer was "negative".  The reporting nurse considered the event to probably be related to vaccination with Energix-B
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described a female patient in her 40's who did not respond to Hep-B vaccine.   On an unspecified date in 2004, the patient received the third dose of Energix-B.  On an unspecified date in SEP 2004, a Hep-B surface antibody titer was "negative".  The reporting nurse considered the event to probably be related to vaccination with Energix-B
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described a male patient in his 40's who did not respond to Hep-B vaccine.   On an unspecified date in 2004 the patient received the third dose of Energix-B.  On an unspecified date in SEP 2004, a Hep-B surface antibody titer was "negative".  The reporting nurse considered the event to probably be related to vaccination with Energix-B
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a physician and described a female patient who did not respond to Hep-B vaccine.   The patient's medical history, concurrent conditions and medications were not reported.  On 06 MAY 2003, 03 JUN 2003, and 03 NOV 2003 the patient received the first dose of Energix-B.  On an unspecified date in APR 2004 a Hep-B surface antibody titer was "negative".  On an unspecified date later in 2004 the patient received a booster dose of Energix-B.  On an unspecified date three to four months later in 2004 a hep-B surface antibody titer was again negative
Sex: U
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: This case was reported by a nurse to a sales representative and described the occurrence of injection site burning in an adult patient who received Hep-B.   On an unspecified date, the patient received a dose of Energix-B in the arm.  At an unspecified period of time following the vaccination on the same day, the patient experienced an injection site reaction characterized as burning.  The nurse considered the injection site reaction to possibly be related to vaccination with Energix-B.
Age: 30.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described a 30 year old male patient who did not respond to the Hep-B vaccine.   On unspecified dates in 2004, the patient received three doses of Energix-B.  Subsequently on 18 OCT 2004 a hep-B surface antibody titer was negative.  The nurse considered the event to probably by related to the use of Energix-B
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: This case was reported by a physician's assistant and described the occurrence of an injection site reaction in a 34 year old female patient who received Hep-B.    On 20 OCT 2004 the patient received the second dose of Energix-B in the right arm.  At an unspecified time following the vaccination on 20 OCT 2004 the patient experienced an injection site reaction characterized as red and firm.  The patient was seen at a physician's office.  The immunization series with Energix-B was discontinued.  The injection site reaction had improved as of 02 NOV 2004.  The physician's assistant considered the injection site reaction to possibly be related to vaccination with Energix-B
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: This case was reported by a nurse practitioner and described the occurrence of a raised red rash in a 60 year old female patient who received Hep-B vaccine.    Concurrently the patient received no other medications.  The patient also reported no known drug allergies  On 21 SEP 2004 the patient received an application of tuberculin purified protein derivative.  The tuberculin test was examined on 23 SEP 2004 with negative results reported.  On 23 SEP 2004 the patient received the first dose of Energix-B.  Approximately seven days later, on 30 SEP 2004 the patient experienced a raided rash on both forearms and both shins. The patient was seen by a nurse practitioner and was treated with topical cortisone.  The immunization series with Energix-B was discontinued.  The rash had improved by 26 Nov 2004.  The nurse practitioner considered the event to be possibly related to vaccination with Energix-B.
Sex: M
Vaccine: HEP
Symptoms: Fatigue, Myalgia
Clinical narrative: This case was reported by a consumer and described the occurrence of body achiness in an adult male pt who received hep B vaccine recombinant (Engerix B). The reporter is the pt. A physician or other health care professional has not verified this report. On 07Oct04, the pt received the first dose of Engerix B in the left arm. Approx 7 days following the admin of Engerix B, on 14Oct04, the pt experienced body achiness and fatigue. The events were ongoing at the time of initial reporting.
Sex: U
Vaccine: HEP
Symptoms: Rash, Vaccine positive rechallenge
Clinical narrative: This case was reported by a pharmacist and described the occurrence of a facial rash in a pt who received hep B vaccine recombinant (Engerix B). On an unspecified date, the pt received the first dose of Engerix b. At an unspecified time following the first admin of Engerix B, the pt experienced a full body rash. The event resolved on an unspecified date. On an unspecified date, the pt received the second dose of Engerix B. At an unspecified time following the second admin of Engerix B, the pt experienced a facial rash. The event resolved on an unspecified date.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Hepatitis B surface antigen positive
Clinical narrative: Hepatitis B surface antigen positive; This case was reported by a physician and described a 57-year-old female patient who received hepatitis B vaccine recombinant (Engerix-B) and subsequently tested positive for hepatitis B surface antigen. Medical history included renal failure (cause not specified) requiring hemodialysis. On 07 January 2004, prior to immunization with Engerix-B, the patient tested negative for hepatitis B surface antibody. On 23 August 2004, the patient received the first dose of Engerix-B (lot AHBVA077AB). Approximately four days later, on 27 August 2004, the patient tested positive for hepatitis B surface antigen. The physician considered the event to be related to vaccination with Engerix-B.
Age: 88.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a physician and described an 87 year old male pt who received Engerix-B and subsequently tested positive for hepatitis B surface antigen. On 1/7/04, prior to immunization with Engerix-B, the pt tested negative for hepatitis B surface antibody. On 8/23/04, the pt received the 1st dose of Engerix-B (lot AHBVA077AB). Approximately 4 days later, on 8/27/04, the pt tested positive for hepatitis B surface antigen. The physician considered the event to be related to vaccination with Engerix-B.
Age: 77.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Hepatitis B surface antigen positive, Laboratory test abnormal, Renal failure
Clinical narrative: Hepatitis B surface antigen positive; This case was reported by a physician and described a 77-year-old male patient who received hepatitis B vaccine recombinant (Engerix-B and subsequently tested positive for hepatitis B surface antigen. Medical history included renal failure (cause not specified) requiring hemodialysis. On 07 January 2004, prior to immunization with Engerix-B, the patient tested negative for hepatitis B surface antibody. On 23 August 2004, the patient received the first dose of Engerix-B (lot AHBVA077AB). approximately four days later, on 27 August 2004, the patient tested positive for hepatitis B surface antigen. The physician considered the event to be related to vaccination with Engerix-B.