chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEP
Symptoms: Medication error, Pruritus
Clinical narrative: This case was reported by a nurse and described the occurrence of back itch in an adult female patient who received hepatitis B vaccine recombinant Engerix B. The patients medical history includes no allergies to medication or yeast. On 01/07/2005, the patient received the first dose of Engerix B. On 2/28/2005, the patient received the second dose of Engerix B. this is longer than the recommended interval of one month between the first and second doses of Engerix B. Approximately five days following the second administration of Engerix B, on 3/5/2005, the patient experienced itching that was localized only to her back. The nurse stated that the patient reported no visible rash associated with the itching. The patient was seen by a physicians office. The outcome of the event was not reported.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: This case was reported by a nurse and described a 28 year old female patient who did not respond to immunization with hepatitis B vaccine recombinant (Engerix B). On May 19 2003, the patient received the first dose of Engerix B (lot ENG529292 incorrect lot number). On 6/23/2006, the patient received the second dose of Engerix B (lot ENG529292 incorrect lot number). Approximately 20 months later, on 2/19/2005, a hepatitis B surface antibody titer was negative. The patient was seen at a physicians office. Report received via manufacturer.
Age: 62.0
Sex: F
Vaccine: HEP
Symptoms: Influenza like illness, Injection site pain, Myalgia, Pain, Viral infection
Clinical narrative: This case was reported by a physician and described the occurrence of a viral syndrome in a 62 year old female patient who received hepatitis B vaccine recombinant Engerix B. The physician reported that the patient was basically healthy. On an unspecified date in Feb 2005, the patient received the first dose of Engerix B in her deltoid. Approximately one week following the 1st dose of Engerix B, on an unspecified date in Feb 2005, the patient experienced flu like aches and muscle soreness in the arm that the shot was given, the soreness extended to the back of the arm. The patient was seen at a physicians office and was diagnosed with viral syndrome. The events resolved three to four days following the onset of symptoms, on an unspecified date in Feb or March 2005. The reporting physician considered the events to not be related to vaccination with Engerix B and probably due to the viral syndrome.
Sex: F
Vaccine: HEP
Symptoms: Injection site reaction, Thermal burn
Clinical narrative: This case was reported by a physician to a sales representative and described the occurrence of injection site burning in an elderly female patient who received hepatitis B vaccine recombinant (Engerix B). On an unspecified date, the patient received a dose of Engerix B (dose number and lot number not provide. The physician reported that the patient complained that the injection burns when being administered. The patient was seen at a physicians office. The outcome of the injection site burning was not provided. The reporting physician considered the injection site burning to probably be related to vaccination with Engerix B.
Sex: F
Vaccine: HEP
Symptoms: Injection site reaction, Thermal burn
Clinical narrative: This case was reported by a physician to a sales representative and described the occurrence of injection site burning in an adult female patient who received a hepatitis b vaccine recombinant Engerix B. On an unspecified date, the patient received a dose of Engerix B (dose number and lot number not provided). The physician reported that the patient complained that the injection burns when being administered. The patient was seen at a physicians office. The outcome of the injection site burning was not provided.  The reporting physician considered the injection site burning to probably be related to vaccination with Engerix B.
Age: 0.72
Sex: M
Vaccine: HEP, IPV
Symptoms: Hypersensitivity, Irritability, Oedema peripheral, Urticaria
Clinical narrative: This case was reported by a nurse and described the occurrence of an allergic reaction in an 8 month old male who received hepatitis B vaccine recombinant (Engerix B). On March 19 2005, the patient received the third dose of Engerix B in the right arm (lot AHBVA0588AA). Concurrently the patient received the first dose of inactivated poliomyelitis virus vaccine (Ipol). The site of injection of IPOL was not provided. On March 21 2005, two days post immunization, the patient experienced urticaria, swelling of his hands and feet, and crankiness. The patient was seen in the ER and was diagnosed with an allergic reaction. The events resolved on March 24 2005. The nurse considered the allergic reaction to be related to vaccination with Engerix B.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Injection site reaction, Paraesthesia
Clinical narrative: This case was reported by a nurse and described the occurrence of an injection site reaction in a 42 year old female patient who received hepatitis B vaccine recombinant Engerix B. On 3/24/2005, the patient received the first dose of Engerix B in the left arm (lot ENg5595B). Almost immediately following the first dose of Engerix B, on 3/24/2005, the patient experienced an injection site reaction characterized as tingling. the injection site tingling was ongoing at the time of initial reporting, 3/28/2005. The nurse considered the injection site reaction to possibly be related to vaccination with Engerix B.
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described an adult female patient who did not respond to immunization with hepatitis B vaccine recombinant (Engerix B). The reporter is the patient. On an unspecified date in 1994, the patient received the third dose of Engerix B. At an unspecified time later, before 3/29/2005, a hepatitis B surface titer was negative. On an unspecified date, the patient received the fourth dose of Engerix B. Approximately 30 days after the fourth dose, on an unspecified date before 3/29/2005, a hepatitis B surface antibody titer was negative. On an unspecified date, the patient received the fifth dose of Engerix B vaccine. Approximately 30 days after the fifth dose, on an unspecified date before Mar 29 2005, a hepatitis b surface antibody titer was negative.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described a patient who did not respond to immunization with hepatitis B vaccine recombinant (Engerix B). The nurse reported that several patients did not respond to immunization with Engerix B, however, patient identifiers were not provided. On an unspecified date, the patient received the third dose of Engerix B. Approximately four to six weeks after the third dose of Engerix B, on an unspecified date, a hepatitis B surface antibody titer was positive. At an unspecified time following the first antibody titer test, on an unspecified date, a second titer for hepatitis B surface antibody was negative.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Anaphylactic reaction, Erythema, Pain, Paraesthesia, Rash
Clinical narrative: This case was reported by a nurse and described the occurrence of anaphylactic reaction in a 17 year old female subject who received hepatitis B vaccine recombinant (Engerix B). On an unspecified date in March 2005 on or before March 28 2005, the subject received the first dose of Engerix B in the left arm (lot AHBV0077AB). At an unspecified time following the first dose of Engerix B, on March 28 2005, the subject experienced soreness, redness, tingling and a rash covering the entire arm. The subject was diagnosed with an anaphylactoid reaction. The events resolved on 3/31/2005. The nurse considered the events to be related to vaccination with Engerix B. Anaphylactoid reaction was considered medically serious by manufacturer (OMIC).
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer and described the occurrence of an injection site reaction in a 44 year old female patient who received hepatitis B vaccine recombinant (Engerix B). The reporter is the patient. A physician or other health care professional has not verified this report. The patients past medical history included allergy to norflex, codeine and bismuth subsalicylate. On 2/25/2005, the patient received the first dose of Engerix B. On 3/23/2005, the patient received the second dose of Engerix B in the arm. At an unspecified time following the second administration of Engerix B, on 3/23/2005, the patient experienced an injection site reaction characterized as pain at the spot where the needle was inserted. The patient was seen at a physicians office. The injection site reaction was ongoing as of 3/23/2005. Report received via manufacturer.
Age: 21.0
Sex: M
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: This case was reported by a nurse and described the occurrence of hives in a 21 year old male patient who received hepatitis B vaccine recombinant Engerix B. The patient had no pre existing medical conditions. On 3/29/2005, the patient received the first dose of Engerix B (lot AHBVA059BA) in the right deltoid. Approximately six days following the first dose of Engerix B, on 4/4/2005, the patient experienced hives and itching. The hives and itching improved on 4/6/2005. The immunization series with Engerix B was discontinued. The nurse considered the hives and itching to  possibly be related to vaccination with Engerix B and that the hives were of questionable etiology.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described a 57 year old female patient who did not respond to immunization with hepatitis B vaccine recombinant Engerix B. On Jan 15 2004, the patient received the 1st dose of Engerix B. On 2/15/2004, the patient received second dose of Engerix B. On 9 21/2004, the patient received the third dose of Engerix B. This is longer than the recommended interval of six months between the first and third doses of Engerix B. On an unspecified date after 9/21/2004 and before 10/28/2004, a hepatitis B surface antibody titer was negative. On 10/28/2004, the patient received the fourth dose of Engerix B. This dose represented the initial dose of the second series of Engerix B. On 12/01/2004, the patient received the fifth dose of Engerix B. On 3/1/2005, the patient received the sixth dose of Engerix B. On an unspecified date after 3/01/2005 an on or before 4/07/2005, a hepatitis B surface antibody titer was negative. The lot numbers for the six doses of Engerix B were not provided.
Age: 54.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described a 54 year old patient who did not respond to immunization with hepatitis B vaccine recombinant (Engerix B). On 04/22/2004, the patient received the first dose of Engerix B (lot ENG5553B2). On 04/25/2004, the patient received the second dose of Engerix B (lot ENG5553B)  On 10/25/2004 the patient received the third dose of Engerix B. On an unspecified date after 10/25/2004 and on or before April 7 2005, a hepatitis B surface antibody titer was negative.
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described a 45 year old male patient who did not respond to immunization with hepatitis B vaccine recombinant (Engerix B). On 04/22/2004, the patient received the first dose of Engerix B (lot ENG5553B2). On 05/24/2004, the patient received the second dose of Engerix B (lot ENG5520A2)  On 10/24/2004 the patient received the third dose of Engerix B (lot number not provided). On an unspecified date after 10/24/2004 and on or before April 7 2005, a hepatitis B surface antibody titer was negative. On an unspecified date in 2005, the patient received a booster dose (lot number not specified) of Engerix B.
Age: 49.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described a patient who did not respond to immunization with hepatitis B vaccine recombinant (Engerix B). On an unspecified date, the patient received the third dose of Engerix B (lot AHBV032AA incorrect lot number). At an unspecified time following the third dose of Engerix B. on Feb 18 2005, a hepatitis B surface antibody titer was negative. On March 2 2005, the patient received the fourth dose of Engerix B (lot AHBV032AA incorrect lot number). Approximately 30 days after the fourth dose of Engerix B, on April 1 2005, a hepatitis B surface antibody titer was negative.
Sex: M
Vaccine: HEP
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a pharmacy technician and described the occurrence of an injection site reaction in a male patient who received hepatitis B vaccine recombinant (Engerix B). On an unspecified date on or before 04/08/2005, the patient received a dose of Engerix B (dose number, lot number, and site of administration not provided). At an unspecified time following the administration of Engerix B, on or before 4/8/2005, the patient experienced an injection site reaction. The outcome of the injection site reaction was not provided.
Sex: U
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of an injection site reaction in an adult patient who received hepatitis B vaccine recombinant (Engerix B). The physician reported that multiple patients experienced injection site reactions with Engerix B, however patient identifiers were not provided. On an unspecified date on or before 4/13/2005, the patient received a dose of Engerix B into the deltoid muscle (dose number not provided, lot AHBVB034BB). the pharmacist referred to the Engerix B as the adult formula. The pharmacist stated that, the patient complained about a lot of pain as the vaccine was going into the muscle. The injection site reaction resolved on an unspecified date after 4/13/2005 and on or before 5/20/2005. The pharmacist considered the injection site reaction to be related to vaccination with Engerix B. The pharmacist reported that he observed, no pain with Engerix B from lot ENG5588A4. The pharmacist also reported that , at another employer, I regularly administered the ENG lot without any untoward reaction reported by the patient. On 05/20/2005. Two Engerix B immunizations were given from lot AHBVB005AA with no pain reported.
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described a patient who did not respond to immunization with hepatitis B vaccine recombinant (Engerix B).  On an unspecified date, the patient received the sixth dose of hepatitis B vaccine (manufacture unknown). Subsequently, on an unspecified date on or before 05/02/2005, a hepatitis B surface antibody titer was negative.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Alanine aminotransferase increased, Aspartate aminotransferase increased, Asthenia, Back pain
Clinical narrative: This case was reported by a physician and described the occurrence of multiple sclerosis in a 30 year old female subject who received with hepatitis B vaccine (manufacture unknown). The subjects medical history was notable for pyelonephritis with reimplantation of the Ureters for reflux at 2 years of age. On an unspecified date on Oct 2001, at 30 years of age, the subject again developed pyelonephritis. Medical history also included chronic back pain, groin pain, dysmenorrhea and ovarian cysts. Concurrent medications included nitrofurantoin (Macrobid) for prophylaxis of pyelonephritis and oral contraceptives to treat ovarian cysts. On Jan 9 2002, the subject received a dose of hepatitis ab vaccine (dose number not provided, lot 1A660 unknown lot number configuration). Approximately 14 days after receipt of hepatitis B vaccine, on 01/23/2002, lab analyses revealed elevated levels of aspartate transaminase (45) and alanine transaminase (89). On an unspecified date in March 2002, the subject experienced weakness of the lower extremities, abdominal pain, back pain, paresthesias and urinary and fecal retention. On an unspecified date in March 2002, magnetic resonance imaging of the brain and spine were negative. The symptoms persisted. On Dec 3 2004 and again on April 15 2004, magnetic resonance imaging of the brain showed two hyperintense lesions in the left hemisphere. On May 19 2004, the subject was diagnosed with multiple sclerosis. The outcome of the events was not provided. Multiple sclerosis, elevated aspartate transaminase, and elevated alanine transaminase were assessed as medically serious by manufacturer (OMIC).
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Laboratory test abnormal, Multiple sclerosis, Paraesthesia, Urinary retention
Clinical narrative: This case was reported by a physician and described the occurrence of multiple sclerosis in a 30 year old female subject who received with hepatitis B vaccine (manufacture unknown). The subjects medical history was notable for pyelonephritis with reimplantation of the Ureters for reflux at 2 years of age. On an unspecified date on Oct 2001, at 30 years of age, the subject again developed pyelonephritis. Medical history also included chronic back pain, groin pain, dysmenorrhea and ovarian cysts. Concurrent medications included nitrofurantoin (Macrobid) for prophylaxis of pyelonephritis and oral contraceptives to treat ovarian cysts. On Jan 9 2002, the subject received a dose of hepatitis ab vaccine (dose number not provided, lot 1A660 unknown lot number configuration). Approximately 14 days after receipt of hepatitis B vaccine, on 01/23/2002, lab analyses revealed elevated levels of aspartate transaminase (45) and alanine transaminase (89). On an unspecified date in March 2002, the subject experienced weakness of the lower extremities, abdominal pain, back pain, paresthesias and urinary and fecal retention. On an unspecified date in March 2002, magnetic resonance imaging of the brain and spine were negative. The symptoms persisted. On Dec 3 2004 and again on April 15 2004, magnetic resonance imaging of the brain showed two hyperintense lesions in the left hemisphere. On May 19 2004, the subject was diagnosed with multiple sclerosis. The outcome of the events was not provided. Multiple sclerosis, elevated aspartate transaminase, and elevated alanine transaminase were assessed as medically serious by manufacturer (OMIC).
Age: 0.01
Sex: M
Vaccine: HEP
Symptoms: Convulsion
Clinical narrative: This case was reported by a medical assistant and described the occurrence of seizure in a 2 day old male subject who was vaccinated with hepatitis B vaccine recombinant (Engerix B) for prophylaxis. On Jan 17 2002, the subject received 1st dose of Engerix B (lot ENG5252A2). At an unspecified time after vaccination with Engerix B, on or after 01/17/2002 an don or before May 4 2005, the subject experienced seizure. The outcome of the seizure was not reported. Comment: seizure was assessed as medically serious by manufacturer (OMIC).
Sex: U
Vaccine: HEP
Symptoms: Malaise
Clinical narrative: This case was reported by a physician and described the occurrence of an unspecified illness in a child of unspecified gender who was vaccinated with hepatitis B vaccine recombinant (Engerix B) for prophylaxis. On an unspecified date on or before May 12 2005, the subject received a dose of Engerix B (dose number nor provided, lot ENG5224B9). The physician reported that, at an unspecified period of time following the administration of Engerix B, on an unspecified date on or before May 12 2005, the subject became very sick. At the time of reporting, May 12 2005, the outcome of the event was not reported.
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: This case was reported by a physician and described the occurrence of rash under eyes in a 3 week old subject of female who was vaccinated with hepatitis B vaccine recombinant Engerix B for prophylaxis. The subject had no known allergies. Concurrently the subject received no medications. On May 6 2005, the subject received the 1st dose of Engerix B. On may 12 2005, 6 days after vaccination with Engerix B, the patient experienced an allergic reaction manifested as a rash beneath the eyes and was seen at a physicians office. The physician described the rash as a rash bilaterally beneath the eyes with micropustles, macro papules, coalescing under the eyes. The physician also reported that he, usually sees this type of rash with topical application of products. As of June 3 2005 the rash had improved. In the reporters opinion, the rash was possibly related to the use of Engerix B.
Sex: U
Vaccine: HEP
Symptoms: Injection site hypersensitivity, Injection site rash, Pruritus
Clinical narrative: This case was reported by a sales representative and described the occurrence of an injection site reaction in a subject of unspecified age and gender who was vaccinated with hepatitis B vaccine, manufacturer unknown, for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date in 1997 the subject received a dose of hepatitis B vaccine (dose number not provided). At an unspecified time after vaccination with hepatitis B vaccine, on an unspecified date in 1997, the subject experienced an injection site reaction characterized as rash and itching. The injection site reaction resolved on an unspecified date on or before May 17 2005.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a pharmacist and described an adult subject of unspecified gender who had a decreased response to vaccination with hepatitis B vaccine recombinant Engerix B, for prophylaxis. the pharmacist states that, four nurses, had a decreased response to vaccination with Engerix B, however patient identifiers were not provided. The pharmacist reported that she, believes that the nurses were probably overweight, smokers and of ethnic origin. On an unspecified date before May 13 2005, the subject received a dose of Engerix B (dose number not provided). At an unspecified time after vaccination with Engerix B, on or before May 13 2005, a hepatitis B surface antibody titer was less than 5 mIU/ml.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Arthritis, Drug ineffective, Medication error
Clinical narrative: This case was reported by a nurse and described the occurrence of arthritis in a 40 year old female subject who was vaccinated with hepatitis b vaccine recombinant Engerix B for prophylaxis. The reporter is the patient. The nurse reported that several other subjects experienced similar problems following the administration of Engerix B, however, no identifiers were provided. Medical history was notable for a finger stick in 1997. On 9/1/1994, the subject received first dose of Engerix B. On 10/24/1994, the subject received the second dose of Engerix B. This is longer than the recommended interval of one month between the first and second dose of Engerix B. On 3/3/1995, the subject received the third dose of Engerix B. Approximately two years after the third dose of Engerix B, on an unspecified date in 1997, the subject was stuck by a needle and was tested for hepatitis B surface antibody. The nurse reported that, the titer did now show antibody to hepatitis B surface antigen. On April 17 1997, the subject received the fourth dose of Engerix B. On Aug 13 1997, the subject received the fifth dose of Engerix B. On January 14 1998 the subject received the sixth dose of Engerix B. This is longer than the recommended interval of six months between the fourth and sixth doses of Engerix B. Following the sixth dose of Engerix B, on Jan 14 1998, the subject experienced severe arthritis. The nurse reported that the arthritis resolved two years later on an unspecified date in 2000. The nurse considered the arthritis to probably be related to vaccination with Engerix B. The nurse stated that she, now 05/18/2005 experienced joint pain due to old age.
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: This case was reported by a nurse and described an adult male patient who did not respond to immunization with hepatitis B recombinant (Engerix-B). Medical history included HIV positive. On unspecified dates, the patient received "two series" of Engerix-B (lot number not provided). Subsequently, on an unspecified date in 2005, a hepatitis B surface antibody titer was "Negative."
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Hypoaesthesia, Nausea, Vision blurred
Clinical narrative: This case was reported by a consumer and described the occurrence of dizziness in a 26 year old female subject who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. The reporter is the mother of the subject. A physician or other health care professional has not verified this report. Concurrent medical conditions included family history of Multiple Sclerosis (mother). On an unspecified date in May 2005, the subject received the first dose of Engerix-B (lot number not specified). At an unspecified time later after the administration of Engerix-B, the subject experienced dizziness, numbness of extremities, blurred vision and nausea. The subject reported to her mother that she had "low sugar" and "all symptoms resolved after eating something sweet." The mother state the symptoms occurred "because my daughter got over-heated." All symptoms resolved within 24 hours.
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a health professional and described a 57 year old female subject who did not respond to immunization with hepatitis B vaccine recombinant Engerix B. Medical history included breast cancer, fatigue, muscle spasms, allergy to sulfa, and social alcohol use. Concurrent medications included tamoxifen to treat breast cancer, modafinil (Provigil) to treat fatigue and baclofen to treat muscle spasms. On 3/10/2004, 4/09/2004, and 09/10/2004, the subject received three doses of Engerix B (lot number not specified). Approximately eight months later, on 5/14/2005, a hepatitis B surface antibody titer was negative. On 6/03/2005, the subject received a booster dose of Engerix B (lot AHBVB005AA).
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a health professional and described a 28 year old female subject who did not respond to immunization with hepatitis B vaccine recombinant Engerix B. The subjects medical history included allergy to erythromycin, asthma, gastroesophageal reflux disease, tobacco use, and social drinking. Concurrent medication included fluticasone propionate + salmeterol xinafoate (Advair) to treat asthma, esomeprazole (Nexium) to treat gastroesophageal reflux disease, and zolpidem (Ambien) for an unspecified drug indication. On 3/1/2004, 4/5/2004, and 9/17/2004, the subject received three dosed of Engerix B (lot number not specified). Approximately seven months later, on an unspecified date on or before 4/25/2005, a hepatitis B surface antibody titer was negative. On 4/25/2005, the subject received a booster dose of Engerix B (lot number not specified.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: This case was reported by a physician and described an adult patient who did not respond to immunization with hepatitis B recombinant vaccine (Engerix-B) immunization series. The physician state that "some" patients did not respond to immunization with Engerix-B; however no patient identifiers were available. Medical history included HIV. The patient's concurrent conditions and concurrent medications were not reported. On unspecified dates, the patient received three doses of Engerix-B (lot number not specified). Subsequently, on an unspecified date later, a hepatitis B surface antibody titer indicated that the patient was "non-immune."
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a pharmacist and described an adult patient who did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series. The patient's medical history, concurrent medical conditions, and concurrent medications were not reported. On unspecified dates, the patient received "a series" (three separate doses) of Engerix-B (lot number not specified). On an unspecified date following the third dose of Engerix-B, a hepatitis B surface antibody titer showed the patient "did not serovoncert."
Sex: U
Vaccine: HEP
Symptoms: Nonspecific reaction
Clinical narrative: This case was reported by a pharmacist and described the occurrence of an unspecified adverse event in a subject of unspecified age and gender who was vaccinated with hepatitis B vaccine recombinant for prophylaxis. On an unspecified date several years ago the subject received unspecified dose of Engerix-B.  The pharmacist reported that "a physician mentioned to me that at an unspecified time after vaccination with Engerix B, the subject, he thinks, had a reaction to it (Engerix-B)".
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a health professional and described a patient of unspecified age and gender who did not respond to immunization with hepatitis B recombinant vaccine (Engerix-B) immunization series.  The health professional stated that seven or eight patients did not respond to immunization with Engerix-B; however no patient identifiers were available. On unspecified dates, the patient received 3 doses of Engerix-B.  Subsequently, on an unspecified date later, a hepatitis B surface antibody titer indicated that the patient did not receive adequate titers.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: This case was reported by a physician and described the occurrence of rash in a 34 year old female subject who was vaccinated with hepatitis B vaccine recombinant for prophylaxis. Concurrent medical conditions included allergy to erythromycin and eczema.  Concurrent medications included Multivitamins for dietary supplementation and Pseudoephedrine hydrochloride for an unspecified medical condition.  On 06/20/2005 the subject received the 1st dose of Engerix-B in the left arm.  On 06/21/2005, 1 day after vaccination with Engerix-B, the subject experienced a rash on the trunk and extremities.  The subject was seen in an emergency room.  The rash was ongoing at the time of initial reporting, 06/22/2005.
Age: 41.0
Sex: M
Vaccine: HEP
Symptoms: Medication error
Clinical narrative: This case was reported by a pharmacist and described a 41 year old male patient who inadvertently received Hepatitis B vaccine recombinant that was stored above the recommended temperature.  Medical history included smoker.  The patient's concurrent conditions, and concurrent medications were not reported.  On 08/12/1992, the patient received the third dose of hepatitis B vaccine.  Approximately 13 years later, on 06/13/2005, a hepatitis B surface antibody titer measured less than 3.0 ml.  On 06/24/2005, the patient received a booster dose of Engerix-B.  The pharmacist reported that prior to the administration the Engerix B "had been stored outside of refrigeration since 06/20/2005".  The recommended storage for Engerix-B is refrigeration between 2 and 8 Celsius.  As of 08/12/2005, no adverse event had occurred.  The reporting pharmacist stated that a follow-up titer would be performed to determine the effectiveness of the Engerix-B booster dose.  In the pharmacist's opinion, the event was possibly related to vaccination with Engerix-B.
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described a 56 year old female subject who did not respond to immunization with Hepatitis B vaccine recombinant.  The subject's medical history included no known allergies.  On an unspecified date in December 2004, the subject received the third dose of Engerix-B.  At an unspecified time following the administration of the third dose of Engerix-B, on or after December 2004 and on or before 06/27/2005, a hepatitis B surface antibody test revealed a titer of less than five.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a physician and described a subject of unspecified age and gender who had a decreased response to immunization with hepatitis B vaccine recombinant Engerix B. The physician reported that an unspecified number of patients experienced a decrease response to Engerix B, however, no subject identifies were provided. Medical history included human immunodeficiency virus infection. On an unspecified date before June 29 2005, the subject received a dose of Engerix B (dose number not provided). At an unspecified time after vaccination with Engerix B on an unspecified date on or before 6/29/2005, a hepatitis B surface antibody titer indicated that the subject had a decreased response to immunization with Engerix B. The physician reported that, my HIV patients have a poorer response rate to Engerix B then my immuno competent patients.
Age: 0.7
Sex: M
Vaccine: HEP
Symptoms: Mental retardation severity unspecified
Clinical narrative: This case was reported by a nurse and described the occurrence of pervasive developmental disorder in a 2 year old male subject who was vaccinated with hepatitis B vaccine recombinant Engerix B for prophylaxis. This report was initially received via manufacturer research. On 3/29/1996, the subject received the first dose of hepatitis B vaccine unknown manufacturer. On 5/10/1996, the subject received the second dose of hepatitis B vaccine recombinant Engerix B (lot ENG2004A2). Approximately nine months after the first dose of hepatitis B vaccine, on 12/9/1996 the subject received the third dose of Engerix B (lot ENG2132A2). The recommended interval between the first and third dose of Engerix B is six months. On 10/9/1998, 22 months after the third dose of Engerix B, the subject was diagnosed with pervasive developmental disorder. The outcome of the event was not reported. The nurse considered the pervasive developmental disorder to not be related to vaccination with Engerix B.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive
Clinical narrative: This case was reported by a nurse and described an adult female subject who was vaccinated with hepatitis B vaccine recombinant Engerix B and subsequently tested positive for the hepatitis B antigen. Medical history included renal failure (cause not specified) requiring hemodialysis. The nurse reported that, on June 20 2005, a hepatitis B antigen test was negative. On 7/1/2005 the subject received the 1st dose of Engerix B. The nurse reported that, on 7/4/2005, 3 days after vaccination with Engerix, the patient was again tested for hepatitis B antigen and was found to be positive. The outcome for the event was not reported. The nurse considered the event to probably be related to vaccination with Engerix B.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive
Clinical narrative: This case was reported by a physicians assistant and described an adult subject of unspecified gender who was vaccinated with hepatitis B vaccine recombinant Engerix B and subsequently tested positive for the hepatitis B antigen. The physicians assistant reported that there were four cases of antigenemia detected following the administration of Engerix B, however subject identifiers were not provided. Medical history included renal failure (cause not specified) requiring hemodialysis. On an unspecified date before July 14 2005, the subject received a dose of Engerix B. The physicians assisted reported that the subject received, either the second, third or booster dose of Engerix B. At an unspecified time after vaccination with Engerix B on or before July 14 2005, the subject tested positive for hepatitis B antigen. The outcome of the event was not reported.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described a patient who did not respond to immunization with hepatitis B vaccine recombinant (Engerix B). The nurse reported that several patients were non responders, however, subject identifiers were not provided. Medical history included renal failure (cause not specified requiring hemodialysis). On an unspecified date before July 12 2005, the subject received the 3rd dose of Engerix B. Approximately two months following the third dose of Engerix B, on an unspecified date on or before 07/12/2005, a hepatitis B surface antibody titer was negative.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Myalgia, Nausea, Rash
Clinical narrative: This case was reported by a pharmacist and described the occurrence of nausea in a 19 year old female subject who was vaccinated with hepatitis B vaccine recombinant (Engerix B) for prophylaxis. Concurrent mediations included Valacyclovir hydrochloride (Valtrex) and Ibuprofen. The subjects medical history included high pitched crying following the administration of the MMR II virus vaccine, as an infant, the MMR series was discontinued. The subjects concurrent conditions were not reported. On an unspecified date in June 2005 the subject received 1st dose of Engerix B (lot number not provided). Approximately 2 hours after vaccination with Engerix B, the subject experienced nausea and a headache. The pharmacist stated the patient complained the headache was the worse headache that she had ever experienced. Approximately three days later, on an unspecified date in June 2005, the patient developed a rash on her chest, back, and arms, and muscle pain. The  headache and nausea resolved after three to four days, the rash resolved three weeks after onset, the resolution date of the muscle pain was an unknown date in July 2005. The pharmacist considered the events nausea, headache and rash to be possibly related to vaccination with Engerix B.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described a patient who did not respond to immunization with hepatitis B vaccine recombinant (Engerix B) immunization series. The subjects medical history, concurrent conditions, and concurrent medication were not reported. On unspecified dates, the patient received three doses of Engerix B. Subsequently, on an unspecified date after immunization with Engerix B, a hepatitis B surface antibody titer indicated that the patient was a non responder. The nurse considered the event to be possibly related to vaccination with Engerix B.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Herpes zoster, Medication error, Vaccine positive rechallenge, Viral infection
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of shingles in a 51 year old female subject who was vaccinated with hepatitis B vaccine recombinant (Engerix B) for prophylaxis. Medical history included arrhythmia. the subject dose not use alcohol or tobacco. Concurrent medications included Atenolol for an unspecified medical condition. On 2/10/2005 the subject received the first dose of Engerix B (lot number not provided). Within 7 to 10 days after vaccination with the first dose of Engerix B, on an unspecified date in Feb 2005, the subject experienced shingles on her back. the shingles resolved four weeks after the outbreak, in an unspecified date in march 2005. On March 24 2005, the subject received the second dose of Engerix B (lot AHBVB052AA. This is longer the recommended interval of one month between the first and second doses of Engerix B. Approximately two weeks or more following vaccination with the second dose of Engerix , on an unspecified date in April 2005, the subject again experienced shingles on the opposite side of her back. The shingles resolved three weeks after the outbreak, on an unspecified date in either April or May 2005. The healthcare professional considered both occurrence of shingles to possibly be related to vaccination with Engerix B. Follow up to this case was received on Sept 20 2005 from the subject. The subject is a nurse. She reported that she was seen at a physicians office as a result of the shingles. She was treated with valacyclovir (Valtrex) and lidocaine patches. The events resolved on an unspecified date. She considered the shingles outbreaks to possibly be related to vaccination with Engerix B.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Medication error
Clinical narrative: This case was reported by a nurse and described an 18 year old female subject who did no respond to vaccination with hepatitis B vaccine recombinant (Engerix B) for prophylaxis. On 10/14/2004 the subject received the first dose of Engerix B (lot ENG5586A).  11/15/2004 the subject received the 2nd dose of Engerix B (lot ENG5586D). On 6/27/2005, the subject received 3rd dose of Engerix B (lot AHBVB074BA). This is longer than the recommended interval of six months between the first and third dosed of Engerix B. Approximately six weeks after the third dose of Engerix B, on or before 8/15/2005, a hepatitis B surface antibody titer indicated that the subject, did not seroconvert.
Age: 67.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described a 67 year old male subject who did not respond to immunization with hepatitis B vaccine recombinant (Engerix B). This report was initially received via manufacturer. Medical history included diabetes and hypertension. Concurrent medications include Ramipril (Altace) to treat hypertension, Metformin hydrochloride (Metformin) and insulin to treat diabetes, Calcium salt and Centrum, Esomepraxole (Nexium) for nutritional supplementation. Concurrent medications also included Hydrochlorothiazide, Thyroxine sodium (Synthroid), Ezetimibe + Simvastatin (Vytorin), Foltx, Metoprolol succinate (Toprol XL) Pioglitazone (Actos), Risedronic acid (Actonel), Carteolol, Bimatoprost (Lumigan), and Aspirin for unspecified drug indications. On 12/14/2004 the subject received the 1st dose of Engerix B (lot ENG5466A4). On 1/24/2005, the subject received the 2nd dose of Engerix B (lot AHBVA059BA) and on 6/23/2005 the subject received the 3rd dose of Engerix B (lot AHBVA059BA). On an unspecified date in 7/2005, the subject was vaccinated with Tetanus toxoid vaccine due to injury. The nurse reported that approximately one week following receipt of the tetanus toxoid vaccine, on 7/21/2005, a hepatitis B surface antibody titer shows non immune response of less than 2 mIU/ml.
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain upper, Asthenia, Dizziness, Gastrointestinal disorder, Headache
Clinical narrative: This case was reported by a nurse and described the occurrence of pain in upper quadrant in a 33 year old  male subject who was vaccinated with hepatitis B vaccine recombinant (Engerix B) for prophylaxis. Medical history included non smoker and allergy to some antibiotics, allergy to prednisone and upset stomach. There were no concurrent medications. On June 24 2005 the subject received the 1st dose of Engerix B in the left arm. On June 26 2005, two days after the vaccination with the first dose of Engerix B, the subject experienced pain in upper right quadrant, gastrointestinal upset, dizziness, headache, and weakness. The events resolved five days later, on 6/30/2005. On Aug 3 2005, the subject received the second dose of Engerix B. This is longer than the recommended interval of one month between the first and second doses of Engerix B. On Aug 5 2005, two days following receipt of the second dose of Engerix B, the subject again experienced pain in upper right quadrant, gastrointestinal upset, dizziness, headache, and weakness, but with greater intensity, and fever, racing heart, and injection site soreness. The events resolved eight days later, on 8/12/2005, and 4 days of that week were spent in bed due to weakness.
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Heart rate increased, Injection site pain, Pyrexia, Vaccine positive rechallenge
Clinical narrative: This case was reported by a nurse and described the occurrence of pain in upper quadrant in a 33 year old  male subject who was vaccinated with hepatitis B vaccine recombinant (Engerix B) for prophylaxis. Medical history included non smoker and allergy to some antibiotics, allergy to prednisone and upset stomach. There were no concurrent medications. On June 24 2005 the subject received the 1st dose of Engerix B in the left arm. On June 26 2005, two days after the vaccination with the first dose of Engerix B, the subject experienced pain in upper right quadrant, gastrointestinal upset, dizziness, headache, and weakness. The events resolved five days later, on 6/30/2005. On Aug 3 2005, the subject received the second dose of Engerix B. This is longer than the recommended interval of one month between the first and second doses of Engerix B. On Aug 5 2005, two days following receipt of the second dose of Engerix B, the subject again experienced pain in upper right quadrant, gastrointestinal upset, dizziness, headache, and weakness, but with greater intensity, and fever, racing heart, and injection site soreness. The events resolved eight days later, on 8/12/2005, and 4 days of that week were spent in bed due to weakness.
Age: 60.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a healthcare professional and described a 60 year old male subject who did not respond to immunization with hepatitis B vaccine recombinant (Engerix B). On 12/15/, 01/21 2005, 06/15/2005, the subject received the first three dosed of Engerix B (lot AHBVB005AA, expiration date 01/23/2006. Approximately one month later, on 8/10/2005, a hepatitis B surface antibody titer was negative.
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Medication error
Clinical narrative: This case was reported by a nurse and described a 55 year old male subject who did not respond to immunization with hepatitis B vaccine recombinant (Engerix B). The subject does not consume alcohol and occasional cigar smoker. On 11/12/2002, the subject received the 1st dose of Engerix B (lot ENG3231D6). On 12/17/2002, the subject received the 2nd dose of Engerix B (lot ENG5371A4). On 4/28/2003, the subject received the 3rd dose of Engerix B (lot ENG5377A4). This represents an interval of five months between the first and third dosed of Engerix B. The recommended interval between the first and third doses of Engerix B is six months. On June 19 2003, a hepatitis B surface antibody titer was less than 2 mIU/ml which indicated that the subject was non immune. On 12/21/2004, the subject received the 4th dose of Engerix B (lot ENG5466A4). On 2/2/2005, the subject received the 5th dose of Engerix B (lot AHBBA059BA). This is longer than the recommended interval of one month between the first two doses of the Engerix B booster series. On July 20 2005, the subject received the 6th dose of Engerix B (lot AHBVA059BA). On 8/17/2005, a hepatitis B surface antibody titer was less than 2 mIU/ml which indicated that the subject was non immune.
Age: 35.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive
Clinical narrative: This case was reported by a pharmacist and described a 34 year old male subject who tested positive for hepatitis B surface antigen following vaccination with hepatitis B vaccine recombinant (Engerix B) for prophylaxis. Medical history included renal failure (cause not specified) requiring hemodialysis, hypertension, anemia and diabetes. Concurrent medications included Epoetin alfa, Venofer, Paricalcitol, Spironolactone, Nephro-Vite, Lisinopril, Warfarin sodium, Sevelamer hydrochloride, and sodium bicarbonate. The indications for the concurrent medications were not provided. On 8/17/2005 the subject received the 4 dose of Engerix B (lot AHBV087AB incomplete lot number). On 8/22/2005, 5 days after vaccination with Engerix B, the subject tested positive for hepatitis B surface antigen. On 8/26/2005, the subject retested and was negative for hepatitis b surface antigen. The pharmacist considered the positive test for hepatitis B surface antigen to be related to vaccination with Engerix B. The pharmacist also reported that the lab test was done too soon with regard to dose. Hospital policy is to have a three week lapse between dose and lab.