chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Dizziness, Hyperhidrosis, Myalgia
Clinical narrative: This case was reported by a nurse practitioner and described the occurrence of lightheadedness in a 57 year old female pt who received hep b vaccine recombinant (Engerix B) for prophylaxis. The pt's medical history included stem cell transplant. Concurrent medications included Prednisone. On 15Dec03, at 11:30AM, the pt received the third dose of Engerix B (lot ENG5456A9). Approx 10 minutes later, on 15Dec03, the pt experienced lightheadedness, body pain, sweating and abdominal discomfort. The pt phoned her physician. The pt stated that the physician did not prescribe any type of treatment. The pt rested in bed. The events resolved on 17Dec03. The nurse practitioner considered the events to possibly be related to vaccination with Engerix B.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a pharmacist and described a 50 year old female pt who did not respond to the hep B vaccine recombinant (Engerix B) immunization series. The pt received her first dose of Engerix B on an unspecified date in 2000. She then received her second dose on an unspecified date in June 2003, followed by her third dose on an unspecified date in Oct 2003. Subsequently in Dec 2003 lab work indicated that the pt did not respond.
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a physician and described an adult male pt did not respond immunization with hep B vaccine (manf unk). The pt's medical history, concurrent conditions, and concurrent medications were not reported. The physician reported that on unspecified dates several years ago, the pt received a series of injections of hep B vaccine (manf unk). The pt also received yearly boosters. It was subsequently determined that the pt never had a detectable titer. The physician stated that he did not know specifically when the titers were being drawn in relation to when the immunization series was completed or boosters were received.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a physician and described a 21 yr old female 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 24Nov03, the pt received the third dose of Engerix B. On 26Nov03, a hep B surface antibody titre was negative. On 02Jan04, a hep B surface antibody titre was again negative.
Age: 31.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a physician and described a 31 yr old male pt who did not respond to the hep B vaccine recombinant (Engerix B) immunization series. The pt received  doses of Engerix B on 15May1998, 15Jun1998, and 14Dec1998. The physician stated that he did not know if he took a titer after the first series, but a hep B surface antibody titre in May 2003 was negative. The pt then received booster doses of Engerix B on 29May03, 07Jul03 and 09Oct03. Repeat hep B surface antibody titers performed in Nov 2003 and Dec 2003 were both negative.
Age: 20.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by an office administrator at a physician's office and described her 20 year old son who did not respond to immunization with hep B vaccine (manf unk). On unspecified dates, the pt received three doses of hep b vaccine (manf unk). On an unspecified date, a hep B surface antibody titer was negative. On 07Dec03, the pt inadvertently received the pediatric dose of hep B vaccine recombinant (Engerix B) as the first dose of a second series of hep B vaccination.
Age: 69.0
Sex: M
Vaccine: HEP
Symptoms: Hepatic enzyme abnormal
Clinical narrative: A 68 yr old male pharmacist reported that he experienced increased liver enzymes after receiving hep A vaccine inactivated (Havrix) and hep B vaccine recombinant (Engerix B) for prophylaxis. Concurrent medications included Atenol. In approx June 2003, the pt received his initial admin with Havrix prior to leaving the country. At an unspecified amount of time later, the pt received the second Havrix vaccination, and his initial admin of Engerix B. One month later he received his second Engerix B vaccination and on 19Dec03 received his third Engerix B vaccination. Approx 6 months after the initial Havrix vaccination, in Dec 2003, diagnostic examination revealed elevated liver enzymes (NOS). The event was unresolved at the time of reporting.
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Insomnia, Joint swelling, Oedema peripheral
Clinical narrative: This case was reported by a nurse practitioner and described the occurrence of wrist and hand swelling in an adult female pt who received hep B vaccine recombinant (Engerix B). The pt had a medical history of allergy to intravenous pyelogram dye. Concurrent medications included aspirin, progesterone and estrogen. On 05Jan04, the pt received the first dose of Engerix B injected into her left arm. The following day, the pt telephoned the physician's office and reported that on 05Jan04 she experienced swelling, pain and soreness in her right wrist and hand and difficulty sleeping. The reporter noted that the pt had been in the midst of a home remodel, but did not recall any specific injury. According to the nurse practitioner, the joint complaints had not been evaluated by a physician. At the time of reporting on 23Feb04, the immunization series had been neither discontinued nor delayed; however, no further doses had been administered. The events resolved. The nurse practitioner considered the events to be possibly related to vaccination with Engerix B.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: This case was reported by a nurse and described the occurrence of arm pain in a 41 yr old female pt who received hep B vaccine recombinant (Engerix B) injection for prophylaxis. On 18Dec03 the pt received the second dose of Engerix B (lot ENG5465A6, 04Dec04) and at an unspecified time the same day experienced arm pain. The immunization series with Engerix B was discontinued. As of 27Jan04, the event was unresolved. The nurse considered the event to be related to vaccination with Engerix B.
Age: 20.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain, Nausea, Vomiting
Clinical narrative: This case was reported by a health professional and described the occurrence of stomach cramps in a 20 yr old male pt (an employee at a dialysis clinic) who received hep B vaccination recombinant (Engerix B). On 13Jan04, the pt received a dose of Engerix B (dose number not specified; Lot ENG5351A4). At an unspecified time following the admin of Engerix B, on 13Jan04, the pt experienced stomach cramps, nausea and vomiting. The pt was seen at an ER. The events resolved on 14Jan04, in about 24 hrs.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: This case was reported by a nurse and described the occurrence of rash in a 52 yr old female pt who received hep B vaccine recombinant (Engerix B). The pt's past medical history included allergy to penicillin. Concurrent medications included Prilosec. On 14Jan04, the pt received the first dose of Engerix B vaccine (lot ENG5520A2) in his left arm. One day later, on 15Jan04, the pt experienced a small rash on his thigh. The event unresolved.
Age: 32.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described a 32 year old male patient who did not respond to the Hepatitis B vaccine recombinant (Engerix-B) immunization series.  On an unspecified date in 2002 or 2003, the patient received the third dose of Engerix-B.  Approximately 6 to 12 weeks later, a hepatitis B surface antibody titer was negative.  The nurse stated that, "All injections were given intramuscularly in the deltoid muscle with a 1 inch needle.  All vaccine is refrigerated and the temperature is monitored daily.  The nurse considered the event to be probably related to vaccination with Engerix-B.
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described a 33 year old male patient who did not respond to the Hepatitis B vaccine recombinant immunization series.  On an unspecified date in 2002 or 2003, the patient received the third dose of Engerix-B.  Approximately 6 to 12 weeks later a Hepatitis B surface antibody titer was negative.  The nurse stated that "All injections were given intramuscularly in the deltoid muscle with a 1 inch needle.  All vaccine is refrigerated and the temperature is monitored daily.  The nurse considered the event to be probably related to vaccination with Engerix-B.
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described a 34 year old male patient who did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series.  On an unspecified date in 2002 or 2003, the patient received the third dose of Engerix-B.  Approximately 6 to 112 weeks later, a hepatitis B surface antibody titer was negative.  The nurse stated that, "All injections were given intramuscularly in the deltoid muscle with a 1 inch needle.  All vaccine is refrigerated and the temperature is monitored daily.  The nurse considered the event to be probably related to vaccination with Engerix-B.
Age: 39.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described a 39 year old male patient who did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series.  On an unspecified date in 2002 or 2003, the patient received the third dose of Engerix-B.  Approximately 6 to 12 weeks later a hepatitis B surface antibody titer was negative.  The nurse stated that, "All injections were given intramuscularly in the deltoid muscle with a 1 inch needle.  All vaccine is refrigerated and the temperature is monitored daily.  The nurse considered the event to be probably related to vaccination with Engerix-B.
Age: 59.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described a 59 year old male patient who did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series.  On an unspecified date in 2002 or 2003, the patient received the third dose of Engerix-B.  Approximately 6 to 12 weeks later a hepatitis B surface antibody titer was negative.  The nurse stated that, "All injections were given intramuscularly in the deltoid muscle with a 1 inch needle.  The nurse considered the event to be probably related to vaccination with Engerix-B.
Age: 60.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described a 60 year old male patient who did not respond to Hep-B vaccine immunization series.    On an unspecified date in 2002 or 2003, the patient received the third dare of Energix-B.  Approximately "6 to 12 weeks" later, a Hep-B surface antibody titer was "negative".  The nurse stated that "All injections were given IM in the deltoid muscle with a 1 inch needle.  All vaccine is refrigerated and the temperature is monitored daily."  The nurse considered the event to be probably related to vaccination with Energix-B
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described a 23 year old female patient who did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series.  On an unspecified date in 2002 or 2003, the patient received the third dose of Engerix-B.  Approximately 6 to 12 weeks later, a hepatitis B surface antibody titer was negative.  The nurse stated that, "All injections were given intramuscularly in the deltoid muscle with a 1 inch needle.  All vaccine is refrigerated and the temperature is monitored daily.  The nurse considered the event to be probably related to vaccination with Engerix-B.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described a 32 year old female patient who did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series.  On an unspecified date in 2002 or 2003, the patient received the third dose of Engerix-B.  Approximately 6 to 12 weeks later, a hepatitis B surface antibody titer was negative.  The nurse stated that, "All injections were given intramuscularly in the deltoid muscle with a 1 inch needle.  The vaccine is refrigerated and the temperature is monitored daily.  The nurse considered the event to be probably related to vaccination with Engerix-B.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described a 41 year old female patient who did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series.  On an unspecified date in 2002 or 2003, the patient received the third dose of Engerix-B.  Approximately 6 to 12 weeks later, a hepatitis B surface antibody titer was negative.  The nurse stated that, "All injections were given intramuscularly in the deltoid muscle with a 1 inch needle.  All vaccine is refrigerated and the temperature is monitored daily.  The nurse considered the event to be probably related to vaccination with Engerix-B.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described a 54 year old female patient who did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series.  On an unspecified date in 2002 or 2003, the patient received the third dose of Engerix-B.  Approximately 6 to 12 weeks later a hepatitis B surface antibody titer was negative.  The nurse stated that, "All injections were given intramuscularly in the deltoid muscle with a 1 inch needle.  The nurse considered the event to be probably related to vaccination with Engerix-B.
Sex: U
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: This case was reported by a medical assistant and described the occurrence of hives in an 11 year old male patient who receive hepatitis B vaccine recombinant (Engerix-B).  On an unspecified date in 2000, the patient received a dose of Engerix-B.  At an unspecified time following administration of Engerix-B, the patient developed hives.  The patient was examined at a physician's office and was treated with oral corticosteroids.  The event resolved.  Report received via Merck and Co.
Sex: U
Vaccine: HEP
Symptoms: Medication error
Clinical narrative: This case was reported by a physician to a sales representative and described the occurrence of a false positive laboratory results for human immunodeficiency virus (HIV) in a patient who received hepatitis B vaccine recombinant (Engerix-B).  On an unspecified dates, the patient received the Engerix-B series.  At an unknown time following administration of Engerix-b, results of an HIV test were "false positive".
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site pain in a 28 year old patient who received hepatitis B vaccine recombinant (Engerix-B).  The patient did not receive any concurrent medications.  On 01/23/2004, the patient received the third and final dose of the series of Engerix-B in the arm.  The expiration date for this administration of Engerix-B was on 12/04/2002.  At an unspecified time following administration of Engerix-B, on 01/23/2004, the patient experienced prolonged injection site pain.  The event resolved on 01/27/2004.  The reporter stated that the event could possibly have been related to erroneous administration, but noted that 2 additional parents had experienced similar events to be probably related to vaccination with Engerix-B.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site pain in a 42 year old female patient who received hepatitis B vaccine recombinant (Engerix-B).  The patient did not received any concurrent medications.  On 01/23/2004, the patient received the third dose and final dose of the series of Engerix-B in the arm.  The expiration date for this lot of Engerix-B was 12/04/2002.  At an unspecified time following administration of Engerix-B on 01/23/2004, the patient experienced prolonged injection site pain.  The event resolved on 01/27/2004.  The reporter stated that the event could possibly have been related to erroneous administration, but noted that 2 additional patients had experienced similar events on the same date.  The pharmacist considered the events to be probably related to vaccination with Engerix-B.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site pain in a 46 year old female patient who received hepatitis B vaccine recombinant (Engerix-B).  The patient did not receive any concurrent medications.  On 01/23/2004, the patient received the sixth dose and final dose of an Engerix-B series in the arm.  The expiration date for this lot of Engerix-B is 12/04/2002.  At an unspecified time following administration of Engerix-B, on 01/23/2004, the patient experienced prolonged injection site pain.  The event resolved on 01/27/2004.  The reporter stated that the event could possibly have been related to erroneous administration, but noted that 2 additional patients had experienced similar events on the same date.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Asthenia, Rash
Clinical narrative: This case was reported by a 39 year old female pharmacist who developed joint pain after she received Engerix-B. The pt stated that, "approximately 10 years ago", on an unspecified date in 4/93, she received the first dose of Engerix-B (lot ENG1039A4). "Approximately one week later", on an unspecified date in 4/93, the pt experienced "disabling severe" joint pain, a bilateral leg rash that extended from the "knee to the lower legs", weakness and fatigue. The events resolved "approximately two weeks later". On 5/14/93, the pt received the second dose of Engerix-B (lot ENG1039A4). "Approximately one week later, the pt again experienced disabling severe joint pain, a bilateral leg rash that extended from the knee to the lower legs, weakness and fatigue. The pt was seen at an ER. The events resolved approximately two weeks later. The vaccination series with Engerix-B was discontinued. The reporting pharmacist considered the events to probaby be related to Engerix-B.
Sex: F
Vaccine: HEP
Symptoms: Liver function test abnormal
Clinical narrative: This case was reported by a nurse via a company representative and described the occurrence of abnormal liver test (NOS) in a female pt who received Engerix-B and Havrix. The pt received Engerix-B and Havrix on unknown dates. At an unknown time after  receiving both vaccines, diagnostic tests revealed abnormal liver test (NOS). The pt was evaluated by a health care provider. The event was unresolved at the time of reporting.
Age: 50.0
Sex: M
Vaccine: HEP
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site reaction in a 50 year old male pt who received Engerix-B. On 1/27/04, the pt received the 3rd dose of Engerix-B. At the time of vaccination, the pt experienced an injection site reaction characterized by "sever" injection site pain. The events were associated with a potential product complaint. On an unspecified date, the events resolved. The nurse considered the events to possibly be related to vaccination with Engerix-B.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site reaction in a 15 year old female who received Engerix-B. On 1/27/04, the pt received the 1st dose of Engerix-B. At the time of vaccination, the pt experienced an injection site reaction characterized by injection site pain. The events were associated with a potential product complaint. On an unspecified date, the events resolved. The nurse considered the events to possibly be related to vaccination with Engerix-B.
Sex: M
Vaccine: HEP
Symptoms: Myelitis transverse
Clinical narrative: This case was reported by a physician and described the occurrence of transverse myelitis in a male pt who received Engerix-B. On an unspecified date, the pt received Engerix-B. Three days later, the pt experienced transverse myelitis. As of 2/10/04, the event remained unresolved. This case was assessed as medically serious by mfr.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: This case was reported by a nurse and described the occurrence of generalized achiness in a 52 year old female pt who received Engerix-B. On 1/6/04, the pt received the 1st dose of Engerix-B "in her arm". At an unspecified time following the administration of Engerix-B, on the same day, the pt experienced general aches all over her body, a headache, a fever of 101F, chills and injection site swelling, redness and soreness. The fever resolved on 1/9/04 and all the other events resolved on 1/13/04. The nurse considered the events to be related to vaccination with Engerix-B.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: This case was reported by a nurse and described the occurrence of generalized achiness in a 52 year old female pt who received Engerix-B. On 1/6/04, the pt received the 1st dose of Engerix-B "in her arm". At an unspecified time following the administration of Engerix-B, on the same day, the pt experienced general aches all over her body, a headache, a fever of 101F, chills and injection site swelling, redness and soreness. The fever resolved on 1/9/04 and all the other events resolved on 1/13/04. The nurse considered the events to be related to vaccination with Engerix-B.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Injection site mass
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site mass in a 31 year old female pt who had received Engerix-B for prophylaxis. In 1/04, the pt received the 2nd dose of Engerix-B. Approximately 1 month after immunization, on 2/23/04, the pt developed injection site mass. She was examined by her physician who stated that the mass looked like a seroma. The event was unresolved at the time of reporting. The nurse considered the events were probably related to vaccination with Engerix-B.
Sex: U
Vaccine: HEP
Symptoms: Cough
Clinical narrative: This case was reported by a pharmacist and described the occurrence of cough in a pt who received Engerix-B for prophylaxis. In 1/04, the pt received the initial dose of Engerix-B. During the month following vaccination, the pt experienced cough which required medical attention in a doctor's office. The event was unresolved at the time of reporting in 2/04.
Sex: U
Vaccine: HEP
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site redness in a pt who received Engerix-B for prophylaxis. On an unknown date, the pt received vaccination with Engerix-B. At an unknown time after receiving Engerix-B, the pt had "deep red" coloration at the injection site. The outcome of the events is unknown.
Sex: U
Vaccine: HEP
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site redness in a pt who received Engerix-B for prophylaxis. On an unknown date, the pt received vaccination with Engerix-B. At an unknown time after receiving Engerix-B, the pt  had "deep red" coloration at the injection site and vomiting. The outcome of the events is unknown.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Laboratory test abnormal, Medication error
Clinical narrative: This case was reported by a nurse and described the occurrence of decreased antibody response in a 21 year old female pt who received Engerix-B injection for prophylaxis. The pt received immunizations with Engerix-B on 6/27/03, 8/11/03 and 12/19/03 (lots ENG5379A4, Eng5379A4 and ENG5456A4 respectively). The vaccine was administered on a 0, 2, and 6 month schedule rather than the recommended schedule of 0, 1, and 6 months. Approx. 2 months after receiving the 3rd vaccination with Engerix-B, on 2/18/04, a hepatitis B surface antibody titer measured 4.2 mIU/mL. The nurse consider the event to be related to vaccination with Engerix-B.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described a 41 year old female pt who did not respond to Engerix-B. On unspecified dates, the pt received the Engerix-B "series". On an unspecified date in 2004, a hepatitis B surface antibody titer was "Negative".
Age: 64.0
Sex: F
Vaccine: HEP
Symptoms: Bronchitis, Bronchospasm, Dysphonia, Headache, Influenza
Clinical narrative: This case was reported by a nurse and described the occurrence of bronchospasm in a 63 year old female pt who received Engerix-B. On 1/13/04, the pt received the 3rd dose of Engerix-B (lot ENG5394A2). "Shortly" following vaccination, the pt experienced flu-like symptoms, nausea, headache, runny nose and a fever of 99F. The events resolved within one week of onset. On 1/21/04, the pt reported onset of new symptoms that she described as "laryngitis", including hoarseness. At an unspecified time following the 3rd dose of Engerix-B, the pt was dx'd with influenza A. Her illness persisted and she was subsequently dx'd with bronchitis and bronchospasm. Hoarseness persisted at the time of reporting; however, the outcome of the remaining events was not reported.
Age: 64.0
Sex: F
Vaccine: HEP
Symptoms: Influenza like illness, Laryngitis, Nausea, Pyrexia, Rhinorrhoea
Clinical narrative: This case was reported by a nurse and described the occurrence of bronchospasm in a 63 year old female pt who received Engerix-B. On 1/13/04, the pt received the 3rd dose of Engerix-B (lot ENG5394A2). "Shortly" following vaccination, the pt experienced flu-like symptoms, nausea, headache, runny nose and a fever of 99F. The events resolved within one week of onset. On 1/21/04, the pt reported onset of new symptoms that she described as "laryngitis", including hoarseness. At an unspecified time following the 3rd dose of Engerix-B, the pt was dx'd with influenza A. Her illness persisted and she was subsequently dx'd with bronchitis and bronchospasm. Hoarseness persisted at the time of reporting; however, the outcome of the remaining events was not reported.
Age: 41.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Fatigue, Myalgia
Clinical narrative: This case was reported by a consumer and described the occurrence of lightheadedness in a 41 year old male pt who received hepatitis B shot for prophylaxis. A physician or other health care professional has not verified this report. Concurrent medications included Aciphex and Paxil tablet over a period of 3 weeks starting on 2/13/04 for obsessive compulsive disorder and generalized anxiety disorder. Paroxetine hydrochloride was continued. The pt stated that for the 1st few days on the product, his physician instructed him to take half of the prescribed Paxil 10mg tablet. His doctor has now titrated him up to taking the full 10mg tablet, once daily. On a date as yet unknown, a dose of Hepatitis B was given. At an unknown time after vaccination, the subject experienced lightheadedness, muscle pain and fatigue. The outcome of the events is unknown. The case has been closed. The case was identified as a vaccine case after check for pharma cases with recent vaccines as concomittant drugs.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Myalgia
Clinical narrative: This case was reported by a physician and described the occurrence of myalgia in a 23 year old female pt who received Engerix-B. On 3/9/04, the pt received the 3rd dose of Engerix-B in her right arm. Approx. 1 day later, on 310/04, the pt experienced myalgia and cephalgia. She was seen at a physician's office. The events resolved on 3/11/04. The reporting physician considered the events to probably be related to vaccination with Engerix-B.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Anorexia, Back pain, Dizziness, Hypotension, Insomnia
Clinical narrative: This case was reported by a pharmacist and described the occurrence of hypotension in a 44 year old female who received Engerix-B. The reporting pharmacist is also the pt. The pt received her 1st and 2nd doses of Engerix-B in 8/03 and 9/03. On 3/8/04, the pt received the 3rd dose of Engerix-B in her left arm. Later the same day, on 3/9/04, the pt experienced hypotension, dizziness, shoulder pain, back pain, lack of appetite and lack of sleep. The events resolved on 3/12/04. The pharmacist considered the events to be related to vaccination with Engerix-B.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of hypotension in a 44 year old female who received Engerix-B. The reporting pharmacist is also the pt. The pt received her 1st and 2nd doses of Engerix-B in 8/03 and 9/03. On 3/8/04, the pt received the 3rd dose of Engerix-B in her left arm. Later the same day, on 3/9/04, the pt experienced hypotension, dizziness, shoulder pain, back pain, lack of appetite and lack of sleep. The events resolved on 3/12/04. The pharmacist considered the events to be related to vaccination with Engerix-B.
Age: 0.09
Sex: M
Vaccine: HEP
Symptoms: Hypotonia
Clinical narrative: This case was reported by a physician and described the occurrence of hypotonia in a 2 month old male pt who received Engerix-B. On 5/10/93, the pt received the 1st dose of Engerix-B. On 6/22/93, the pt received the 2nd dose of Engerix-B. At an unspecified time following the 2nd administration of Engerix-B, in 1993, "at 2 months of age", the pt was seen at a physician's office and dx'd  with hypotonia. The immunization series with Engerix-B was discontinued. As of 3/24/03, the event was unresolved.
Age: 14.0
Sex: F
Vaccine: HEP, TD
Symptoms: Guillain-Barre syndrome, Paralysis
Clinical narrative: This case was initially reported by a consumer and confirmed by a pediatrician and described the occurrence of Guillain Barre Syndrome in her 13 year old daughter who received Engerix-B. This case has been reported directly to VAERS. On 10/12/00, the pt received the first dose of Engerix-B, lot ENG3332A9. On the same day, the pt received an injection of TD. Eight days post-immunization. On 10/20/00, the pt experienced Guillain Barre Syndrome with partial paralysis which was considered life-threatening. The pt was seen at a physician's office and subsequently hospitalized. On an unspecified date, the events resolved. The immunization series was delayed. The immunization series was restarted on 5/11/04 with Recombivax without inicident. The physician considered the events to be possibly related to vaccination with Engerix-B. The mother stated "Please understand, Guillain Barre Syndrome's (sic) cause is unknown. There is no definite way to prove that it came from vaccine. There is evidence that some patients who have had the disease had a vaccine relatively soon to having the disease. My daughter had a vaccine, but also had a sinus/virus infection." The pediatrician reported that the sinus/virus infection symptoms onset on 10/4/00. Report subsequently received via Mfr. (Note: the pediatrician also submitted a report to VAERS.) Comment: Guillain Barre Syndrome was assessed as medically serious by MFR.
Age: 0.05
Sex: M
Vaccine: HEP
Symptoms: Candidiasis
Clinical narrative: This case was reported by a consumer and described the occurrence of oral thrush in a 14 day old male pt who received Hepatitis B vaccine. A physician or other health care professional has not verified this report. On an unspecified date in 2004, the pt received the 1st dose of Hepatitis B vaccine. At an unspecified time following administration of vaccine in 2004, the pt experienced oral thrush. The pt was seen at a physician's office. The event resolved on an unspecified date.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Fibromyalgia
Clinical narrative: This case was reported by a nurse and described the occurrence of exacerbation of fibromyalgia in a 46 year old female who received Engerix-B. On 1/30/04, the pt received the 2nd dose of Engerix-B (lot ENG35456A4). Following the administration of Engerix-B, on an unspecified date, in 2/04, the pt developed a "flare-up" of her fibromyalgia. The nurse considered the event to possibly be related to vaccination with Engerix-B. The nurse also reported that, "The event could have been associated with thimerosol, but it is not definite".
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: This case was reported by a nurse and described the occurrence of lightheadedness in a 36 year old female patient who received hepatitis B vaccine recombinant (Engerix-B).  On 03/04/2004, the patient received the first dose of Engerix-B.  At an unspecified time following the administration of Engerix-B, on March 2004, the patient experienced lightheadedness, dizziness, nausea and vomiting.  The patient was seen at a physician's office.  The outcome of the event is unknown.
Age: 0.26
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a pharmacist and described a 3 month old female patient who received hepatitis B vaccine recombinant (Engerix-B) and tested positive for hepatitis B surface antigen.  On 03/18/2004, the patient received the first dose of Engerix-B.  Approximately four days later, on 03/22/2004, laboratory evaluations revealed that the patient tested positive for hepatitis B surface antigen.
Sex: M
Vaccine: HEP
Symptoms: Eye irritation, Ocular hyperaemia
Clinical narrative: This case was reported by a nurse and described the occurrence of red itchy eyes in a male patient who received hepatitis B vaccine recombinant (Engerix-B).  On 03/30/2004, the patient received the first dose of Engerix-B.  The same day, on 03/30/2004, the patient experienced red itchy eyes.  The patient was seen at a physician's office.  The event worsened.
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Thyroxine increased
Clinical narrative: This case was reported by a nurse and described the occurrence of increased thyroid function tests in a 34 year old male patient who received hepatitis B vaccine recombinant (Engerix-B) injection for prophylaxis.  The patient's past medical history included hepatitis C and a positive PPD skin test without active disease.  On 01/08/2003 the patient received his initial immunization with Engerix-B.  Approximately 4 month later, on 05/19/2003, the patient received his second immunization with Engerix-B vaccine.  This represents an inappropriate schedule of vaccine administration, as the recommended schedule for immunization with Engerix B is 0,1, and 6 months.  Approximately six months after receiving the second vaccination with Engerix-B, on 11/24/2003, diagnostic tests revealed elevated thyroid levels.  Thyroid stimulating hormone and thyroxine values were each elevated from baseline.  On 02/12/2004, thyroid levels were further elevated.  The outcome of the events is unknown.
Sex: M
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: This case was reported by a health professional and described the occurrence of fever in a male patient who received hepatitis B vaccine injection for prophylaxis.  In approximately 2000 or 2001, the patient received hepatitis B vaccine.  At an unknown time after immunization with hepatitis B vaccine, the patient developed a fever of 103 to 104 degrees Fahrenheit.  Hepatitis B vaccine was not re-administered.  The outcome of the event is unknown.
Age: 50.0
Sex: M
Vaccine: HEP
Symptoms: Pruritus
Clinical narrative: This case was reported by a medical assistant and described the occurrence of itching on bottom of feet in a 49 year old male patient who received hepatitis B vaccine recombinant (Engerix-B).  On 03/09/2004, the patient received the first dose of Engerix-B.  Approximately 3 days after administration of Engerix-B, on 03/12/2004, the patient experienced itching on bottom of feet.  On an unspecified date, the event resolved.  The medical assistant considered the event to probably be related to vaccination with Engerix-B.
Sex: F
Vaccine: HEP
Symptoms: Alopecia
Clinical narrative: This case was reported by a pharmacist and described the occurrence of alopecia of scalp in an adult female patient who received hepatitis B vaccine recombinant.  On an unspecified date, the patient received a dose of Engerix-B.  At an unspecified time following the administration of Engerix-B, the patient experienced alopecia of scalp and alopecia of eyebrows.  The patient was seen at a physician's office.  The events were unresolved.   The reporting pharmacist considered the events to probably be related to vaccination with Engerix-B.
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Convulsion
Clinical narrative: This case was reported by a nurse and described the occurrence of seizure in a 36 year old male patient who received hepatitis B vaccine recombinant.  On 04/19/2004, the patient received the first dose of Engerix-B.  Approximately 10 minutes following the administration of Engerix-B, on 04/19/2004 the patient experienced a seizure.  The patient was seen in an emergency room.  The event resolved on 04/19/2004.  The vaccination series with Engerix-B was discontinued.  Comment:  Seizure was assessed as medically serious by GSK.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Fatigue, Influenza like illness, Muscular weakness, Myalgia
Clinical narrative: This case was reported by a health professional and described the occurrence of muscular ache of the thigh in a 49 year old female patient who received hepatitis B vaccine recombinant (Engerix-B).  The patient's past medical history included adenotonsillectomy, appendectomy, arthritis, hypercholesterolemia, hysterectomy and ostepenia.  The patient also had family history of coronary heart disease and unspecified thyroid problems.  Concurrent medications included Multivitamin, Soy, Magnesium, Vitamin B, Fish Oil, Guggulipid, Baby aspirin, Actonel, Flax seed oil and calcium.  On 04/06/2004, the patient received the first dose of Engerix-B in her left arm.  At an unspecified time after the administration of Engerix-B on 04/06/2004, the patient experienced muscular aches in her thighs, joint aches, fatigue, muscle weakness, rash on her neck and forearms, and flu-like symptoms.  The events resolved on 04/08/2004.  The immunization series with Engerix-B was discontinued.  The health professional considered the events to possibly be related to vaccination with Engerix-B.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: This case was reported by a health professional and described the occurrence of muscular ache of the thigh in a 49 year old female patient who received hepatitis B vaccine recombinant (Engerix-B).  The patient's past medical history included adenotonsillectomy, appendectomy, arthritis, hypercholesterolemia, hysterectomy and ostepenia.  The patient also had family history of coronary heart disease and unspecified thyroid problems.  Concurrent medications included Multivitamin, Soy, Magnesium, Vitamin B, Fish Oil, Guggulipid, Baby aspirin, Actonel, Flax seed oil and calcium.  On 04/06/2004, the patient received the first dose of Engerix-B in her left arm.  At an unspecified time after the administration of Engerix-B on 04/06/2004, the patient experienced muscular aches in her thighs, joint aches, fatigue, muscle weakness, rash on her neck and forearms, and flu-like symptoms.  The events resolved on 04/08/2004.  The immunization series with Engerix-B was discontinued.  The health professional considered the events to possibly be related to vaccination with Engerix-B.
Sex: F
Vaccine: HEP
Symptoms: Nasal congestion, Obstructive airways disorder, Prinzmetal angina, Pruritus, Rash
Clinical narrative: This case was reported by a female nurse and described her experience of Stevens Johnson Syndrome after receiving hepatitis B vaccine recombinant.  On an unspecified date, the patient received the third dose of Engerix-B.  At an unspecified time following the administration of the third dose of Engerix-B, a hepatitis B surface antibody titer was negative.  The patient was given a fourth dose of Engerix-B.  The patient stated that she had, some type of reaction following each dose of Engerix-B.  On an unspecified date in 1997, the patient received the fifth dose of Engerix-B.  At an unspecified time following the administration of the fifth dose of Engerix-B, in 1997, the patient experienced Stevens Johnson Syndrome, fluid in the lungs, chest congestion, rash, and itching.  The patient was seen in the emergency room.  The events resolved on an unspecified date.  The reporter stated that she still has scarring.  The nurse considered the events to probably be related to vaccination with Engerix-B.  The nurse subsequently stated that she had two problems as a result of the incident.  She had an underlying pigment change in skin - it appears like a rash all over.  She was also super sensitive to sun exposure.  She turned bright red and burned easily.  She incidentally reported that in April 2000, she was diagnosed with prinzmetal's angina.  It was unknown whether this was genetic or acquired.  As this incidentally reported during the course of follow up of her Stevens Johnson Syndrome, this was not coded as an adverse event.  She did not provide permission to contact her physician; therefore, this case is closed. Comment:  Stevens Johnson Syndrome, fluid in the lungs, and chest congestion were assessed as medically serious by GSK.
Sex: F
Vaccine: HEP
Symptoms: Stevens-Johnson syndrome
Clinical narrative: This case was reported by a female nurse and described her experience of Stevens Johnson Syndrome after receiving hepatitis B vaccine recombinant.  On an unspecified date, the patient received the third dose of Engerix-B.  At an unspecified time following the administration of the third dose of Engerix-B, a hepatitis B surface antibody titer was negative.  The patient was given a fourth dose of Engerix-B.  The patient stated that she had, some type of reaction following each dose of Engerix-B.  On an unspecified date in 1997, the patient received the fifth dose of Engerix-B.  At an unspecified time following the administration of the fifth dose of Engerix-B, in 1997, the patient experienced Stevens Johnson Syndrome, fluid in the lungs, chest congestion, rash, and itching.  The patient was seen in the emergency room.  The events resolved on an unspecified date.  The reporter stated that she still has scarring.  The nurse considered the events to probably be related to vaccination with Engerix-B.  The nurse subsequently stated that she had two problems as a result of the incident.  She had an underlying pigment change in skin - it appears like a rash all over.  She was also super sensitive to sun exposure.  She turned bright red and burned easily.  She incidentally reported that in April 2000, she was diagnosed with prinzmetal's angina.  It was unknown whether this was genetic or acquired.  As this incidentally reported during the course of follow up of her Stevens Johnson Syndrome, this was not coded as an adverse event.  She did not provide permission to contact her physician; therefore, this case is closed. Comment:  Stevens Johnson Syndrome, fluid in the lungs, and chest congestion were assessed as medically serious by GSK.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Aspartate aminotransferase increased, Pain, Pyrexia, Rash
Clinical narrative: This case was reported by a consumer and described the occurrence of increased aspartate aminotransferase levels in a 13 year old female relative who received hepatitis B vaccine recombinant.  A physician or other healthcare professional has not verified this report.  The reporter stated that the patient's past medical history included being fine prior to immunization with Engerix-B.  On an unspecified date, the patient received the first dose of Engerix-B.  On an unspecified date, the patient experienced an increased aspartate aminotransferase level, chronic pain, rash and fever.  Outcome was not specifically reported.  On an unspecified date in April 2003, the patient received the second dose of Engerix-B.  At an unspecified time following the second administration of Engerix-B, the events reocurred.  On an unspecified date, the patient received hepatitis B vaccine as the third dose in the immunization series.  It is unknown if the events reocurred following the administration of Recombivax-HB.  The patient was seen at a physician's office.  At time of reporting, the rash and fever resolved.  The increased asparate aminotransferase level and chronic pain were unresolved.
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 the hepatitis B vaccine.  The patient's medical history, concurrent conditions and concurrent medications were not reported.  On unspecified dates the patient received the hepatitis B vaccine series.  On an unspecified date in 2004, a hepatitis B surface antibody titer was negative.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a pharmacist and described a patient who did not respond to the hepatitis B vaccine recombinant immunization series.  The patient's medical history, concurrent medical conditions, and concurrent medications were not reported.  On an unspecified date, the patient received the third dose of Engerix-B.  On an unspecified date following the third dose Engerix-B, a hepatitis B surface antibody titer showed no immune response.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Bacterial infection
Clinical narrative: This case was reported by a nurse and described the occurrence of a systemic yeast infection in a 39 yr old female pt who received hep B vaccine recombinant (Engerix B). The pt's past medical history included a prior history of yeast sensitivity, but it had been under control prior to Engerix B admin. On 22Aug97, the pt received the first dose of Engerix B. On 19Sep97, the pt received the second dose of Engerix B. On 01Feb98, the pt received the third dose of Engerix B (lot ENG2930A2). Approx one year after the third dose of Engerix B, on an unspecified date in 1999, the pt experienced recurrent systemic yeast infections. The event was unresolved.
Age: 39.0
Sex: M
Vaccine: HEP
Symptoms: Influenza like illness, Malaise, Nausea
Clinical narrative: This case was reported by a consumer and described the occurrence of flu like symptoms in a 39 year old male pt who received hep B vaccine (unk manf). A physician or other health care professional has not verified this report. On 22Jun02, the pt received the fourth or fifth dose of hep B vaccine. At an unspecified time following the admin of hep B vaccine, on 22Jun02, the pt experienced flu-like symptoms, malaise, and nausea. The pt stated that following the admin of hep B vaccine, he was out of work the afternoon of 22Jun2002. On an unspecified date, the events resolved.
Sex: U
Vaccine: HEP
Symptoms: Injection site reaction, Pain, Skin burning sensation
Clinical narrative: This case was reported by a pharmacist and described the occurrence of an injection site reaction in an adult pt who received hep B vaccine recombinant (Engerix B). The pharmacist reported several pt's experienced an injection site reaction following administration of Engerix B, however, pt identifiers were not provided. On an unspecified date, the pt received the first dose of hep B vaccine (Recombivax HB). On an unspecified date in 2004, the pt received the second dose in the hep B immunization series with Engerix B. The reporter stated that the Engerix B for this second dose came from either of two lots (ENG5563A4 or ENG5563B4). At an unspecified time following the administration of Engerix B, on an unspecified date in 2004, the pt experienced an injection site reaction characterized by stinging and burning. The outcome of the events is unk.