chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Axillary pain, Chest pain, Injection site pain, Lymphadenopathy, Lymphadenopathy
Clinical narrative: Information has been received from a healthcare professional (who is also the patient) who on an unspecified date was vaccinated (route and site not reported) with the 2nd dose of Gardasil (lot# not reported). On 04-DEC-2007, after receiving the 2nd dose of Gardasil, the patient experienced inflamed lymph node, a pain all throughout her left arm which was the injection site and across her chest. No diagnostic laboratory test were performed. Per the patient, the "swelling has improved and so has the pain". At the time of this report the patient was recovering. Additional information has been requested. 04/07/2008 Initial and follow-up information has been received from a medical assistant (who is also the patient) with allergies to azithromycin and benzoyl peroxide, who on 03-DEC-2007 was vaccinated in the left arm with the 2nd dose of GARDASIL (lot# 658538/1061U). There were no illnesses at the time of the vaccination. On 05-DEC-2007 (previously reported as 04-DEC-2007), the patient experienced inflammed lymph nodes, a pain all throughout her left arm which was the injection site and across her chest. It was reported that no palpable axillary lymph nodes were on the physical examination. However, the patient reported that there was increased pain with palpation of left axilla. There was no adenopathy at other sites. No diagnostic laboratory test were performed. Per the patient, the "swelling has improved and so has the pain". At the time of this report the patient was recovering. On 22-DEC-2007 that patient was vaccinated in the right arm with a third dose of hepatitis B virus vaccine (unspecified). Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a healthcare professional (who is also the patient) who on an unspecified date was vaccinated (route and site not reported) with the 2nd dose of Gardasil (lot# not reported). On 04-DEC-2007, after receiving the 2nd dose of Gardasil, the patient experienced inflamed lymph node, a pain all throughout her left arm which was the injection site and across her chest. No diagnostic laboratory test were performed. Per the patient, the "swelling has improved and so has the pain". At the time of this report the patient was recovering. Additional information has been requested. 04/07/2008 Initial and follow-up information has been received from a medical assistant (who is also the patient) with allergies to azithromycin and benzoyl peroxide, who on 03-DEC-2007 was vaccinated in the left arm with the 2nd dose of GARDASIL (lot# 658538/1061U). There were no illnesses at the time of the vaccination. On 05-DEC-2007 (previously reported as 04-DEC-2007), the patient experienced inflammed lymph nodes, a pain all throughout her left arm which was the injection site and across her chest. It was reported that no palpable axillary lymph nodes were on the physical examination. However, the patient reported that there was increased pain with palpation of left axilla. There was no adenopathy at other sites. No diagnostic laboratory test were performed. Per the patient, the "swelling has improved and so has the pain". At the time of this report the patient was recovering. On 22-DEC-2007 that patient was vaccinated in the right arm with a third dose of hepatitis B virus vaccine (unspecified). Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antigen positive
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hepatitis b surface antigen positive in a 34-year-old female subject who was vaccinated with Engerix B for prophylaxis.  The reporter was a friend of the subject.  On 14 April 2007 the subject received unspecified dose of Engerix B (unknown, unknown arm).  On 21 April 2007, the subject donated blood.  A diagnostic test report dated 07 May 2007, less than one month after vaccination with Engerix B, revealed that the subject was positive for hepatitis B surface antigen.  A confirmatory test for hepatitis B surface antigen was also positive.  At the time of reporting the outcome of the event was unspecified.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician concerning a 19 year old female with penicillin allergy who on 18-MAY-2007 was vaccinated (site and route not reported) with the 1st dose of Gardasil (lot# 656051/0244U).  On 17-Jul-2007, the patient was vaccinated (site and route not reported) with the 2nd dose of the Gardasil (lot#658100/0525U).  On 23-Nov-2007, the patient was vaccinated (site and route not reported) with the 3rd dose of the Gardasil (lot#658560/1062U).  On approximately 25-MAY-2007, 24-JUL-2007 and 30-NOV-2007, 7 days post vaccination, the patient developed a rash all over her body.  The physician stated that she was only aware of the rash after the 1st dose of the vaccine.  The patient was treated, the 1st time with a topical steroid.  No diagnostic laboratory tests were performed.  The patient recovered.  No other information available.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration, Lethargy, Pyrexia
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 15 year old female patient with asthma and rhinitis allergic, who on an unspecified date was vaccinated with the first dose of Gardasil (lot # not provided). A few hours after the vaccination, the patient became lethargic, developed a fever (value not specified) and had induration around the injection site. The symptoms lasted for approximately 3 days before the patient recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Paraesthesia, Paraesthesia oral, Swollen tongue
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female who was vaccinated into the left arm with a 0.5 ml third dose of Gardasil.  On 06-Dec-2007, the patient experienced a tingling feeling on her tongue.  The patient also experienced numbness on the top of her right hand, right foot and right leg.  The patient was given diphenhydramine hydrochloride (Benadryl) and the experiences went away.  Unspecified medical attention was sought.  On 07-Dec-2007, the patient recovered. 02/10/2010 There were not illnesses at the tiem of the vaccination. On 06-DEC-2007, the patient experienced a tingling feeling on her tongue. The patient also experienced numbness on the top of her right hand , right foot and right leg, which resolved spontaneously. Tbe patietn developed a swollen tongue on the evening of the vaccination. It was reported that 72 hours later the swelling was not evident upon inspection. The patient was given Benadryl and the experiences went away. Unspecified medical attention was sought. No laboratory diagnostics were performed. On 07-DEC-2007, the patient recovered.  Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with hepatitis B vaccine (manufacturer unspecified) for prophylaxis.  On an unspecified date the subject received unspecified dose of hepatitis B vaccine (unknown).  At an unspecified time after vaccination with hepatitis B vaccine, the subject experienced not responding to therapy.  At the time of reporting the outcome of the event was unspecified.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Paraesthesia
Clinical narrative: Information has been received from a registered nurse concerning a 25 year old female with no pertinent medical history who on 06-Dec-2007 was vaccinated intramuscularly with a 0.5 ml dose of Gardasil (Lot #659437/1266U).  There was no concomitant medication.  On 06-Dec-2007, the patient developed generalized tingling and burning throughout her body including her genitals.  There was no laboratory or diagnostic tests performed.  The patient called the office.  At the time of the report the patient had not recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a nurse practitioner concerning a female who was vaccinated with a 0.5 ml first dose of Gardasil. Subsequently, the patient experienced "swelling on her arm". Unspecified medical attention was sought. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 30.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of not responding to therapy in an adult male subject who was vaccinated with Engerix B (manufacturer unspecified) for prophylaxis.  On an unspecified date the subject received unspecified dose of Engerix B vaccine (unknown).  At an unspecified time after vaccination with Engerix B vaccine, the subject experienced not responding to therapy.  At the time of reporting the outcome of the event was unspecified.  Follow-up information received on 13 June 2007 indicated that the subject was 30 years old at the time of the event.  In the reporter's opinion, the event was related to treatment with Engerix B vaccine.  The subject tested Hepatitis B surface antibody negative.  Outcome was not stated.
Age: 16.0
Sex: F
Vaccine: HPV4, UNK
Symptoms: Dizziness, Nausea
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female, who, on an unspecified date "several weeks ago", was vaccinated intramuscularly with a 0.5mL first dose of Gardasil.  Concomitant therapy included "another vaccine" (therapy unspecified).  Subsequently the patient experienced nausea and dizziness.  The patient did not seek medical attention.  The patient recovered the same day on an unspecified date.  No product quality complaint was involved.  Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Therapeutic response decreased
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of decreased therapeutic response in a subject of unspecified age and gender who was vaccinated with hepatitis B vaccine (manufacturer unspecified) for prophylaxis.  On an unspecified date the subject received 3rd dose of hepatitis B vaccine at 20 mcg in an unknown deltoid to complete the three dose series.  An unspecified amount of time after completion of the hepatitis B vaccine series, the subject was tested and noted to have decreased response to vaccination.  At the time of reporting the event was unresolved.  Follow-up information received via the reporter on 21 May 2007 indicated that the reaction that the subject experienced was determined to be due to another unspecified condition that the subject has and not related to hepatitis B vaccine.  No further information will be reported.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pruritus, Pruritus
Clinical narrative: Information has been received from a health professional concerning a 20 year old female who on 06-OCT-2007 was vaccinated with Gardasil IM. On 06-OCT-2007 the patient experienced itching from the injection site down to her fingers that lasted for about 48 hours post vaccination. Subsequently, the patient recovered from itching from the injection site. The patient sought medical attention with a doctors office visit. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a pharmacist concerning a female (age not reported) who on an unspecified date was vaccinated with a dose of Gardasil. The pharmacist reported that the patient developed hives after receiving the vaccine and went to the emergency room because 3 months later she still had hives. The patient was not admitted to the hospital. The patient's status was reported as unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 04-DEC-2007 was vaccinated with the second dose of Gardasil (Lot# 656050/0245U) and fainted.  It was reported that the patient was fine before leaving the office and had fully recovered on 04-DEC-2007.  The patient sought unspecified medical attention.  It was reported that the patient did not have this experience after receiving the first dose (date unspecified).  Additional information has been requested. This is in follow-up to report(s) previously on 1/7/2008. Information has been received from a physician concerning a 15 year old female (88 lbs., 63 in.) who on 04-DEC-2007 was vaccinated with the second dose of GARDASIL (Lot# 656050/0245U) and fainted. The episode lasted about 2 seconds and the patient got up and was doing well. The patient was placed on observation for about 10 minutes and was sent home doing well. No additional information is expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abnormal behaviour, Crying, Hepatitis B test negative, Lymphadenopathy, Metrorrhagia
Clinical narrative: Information has been received from a consumer, concerning her 16 year old daughter with no pertinent medical history, who on 21-NOV-2007 was vaccinated in the left arm, with the first dose of Gardasil (lot # not reported).  There was no concomitant medication.  On 23-NOV-2007 the patient experienced spotting that lasted for 11 days.  She also developed an "enlarged lymph, like an almond sized node" in her groin and left arm pit, vomiting and nausea, "has always been crying," and is not acting like herself (dates not specified).  On 27-NOV-2007, the patient had labwork performed, inclusive of a screen for hepatitis B, with results indicative only of an elevated white blood count.  On 03-DEC-2007, the had an ultrasound of her spleen and kidneys, with no abnormal results found.  At the time of this report the outcome of "spotting" was recovered, and the outcome of all remaining events was not recovered.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Ultrasound abdomen normal, Ultrasound kidney normal, Vomiting, White blood cell count increased
Clinical narrative: Information has been received from a consumer, concerning her 16 year old daughter with no pertinent medical history, who on 21-NOV-2007 was vaccinated in the left arm, with the first dose of Gardasil (lot # not reported).  There was no concomitant medication.  On 23-NOV-2007 the patient experienced spotting that lasted for 11 days.  She also developed an "enlarged lymph, like an almond sized node" in her groin and left arm pit, vomiting and nausea, "has always been crying," and is not acting like herself (dates not specified).  On 27-NOV-2007, the patient had labwork performed, inclusive of a screen for hepatitis B, with results indicative only of an elevated white blood count.  On 03-DEC-2007, the had an ultrasound of her spleen and kidneys, with no abnormal results found.  At the time of this report the outcome of "spotting" was recovered, and the outcome of all remaining events was not recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Information has been received from a physician concerning a female who on 04-DEC-2007 was vaccinated with Gardasil. The nurse administering the vaccine had blood mix in the syringe after aspirating. The nurse discarded the syringe with the Gardasil and blood mixture. The patient did not receive any product from this syringe. The office gave the patient another Gardasil (new vial and syringe) that was free of blood at another site. On 04-DEC-2007 the patient experienced pain because it required 2 skin penetrations to get 1 Gardasil dose. Neither dose was a prefilled syringe. The patient sought medical attention in the office and her outcome was not reported. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female with no drug reactions/allergies who on 03-DEC-2007 was vaccinated IM in the left arm with the first dose of Gardasil (lot # not reported).  There was no concomitant medication.  On 04-DEC-2007 the patient experienced itching in her right leg and rash on her stomach and all extremities.  The patient's itching in her right leg and rash on stomach and extremities persisted.  No laboratory diagnostic tests were performed.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Joint stiffness, Musculoskeletal stiffness
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old female who on 12-NOV-2007 was vaccinated in the left deltoid with the first dose of Gardasil (lot # 659437/1266U).  On 16-NOV-2007 the patient complained of stiff neck, stiff joints and stiff fingers.  The patient's status was not reported.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/7/2008. Information has been received from a registered nurse concerning a 22 year old year old white female weighing 127 pounds and height of 63 inches who at 4:21 PM on 13-NOV-2007 (also reported as 12-NOV-2007) was vaccinated IM in the left deltoid with the first dose of GARDASIL (lot # 659437/1266U). On 16-NOV-2007 the patient complaint of stiff neck, stiff joints and stiff fingers. The patient's status was not reported. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Information has been received from a physician concerning a 19 year old female with a history of low blood pressure who on 02-Oct-2007 was vaccinated with her first dose of Gardasil IM (lot #655849/0263U).  On 02-Oct-2007 the patient "passed out".  Subsequently, the patient recovered from passing out and was fine before leaving the office.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/7/2008. Information has been received from a physician concerning a 19 year old female (111 lbs., 63 in.) with a history of low blood pressure who on 02-OCT-2007 was vaccinated in the left arm with her first dose of GARDASIL IM (lot# 659849/0263U). On 02-OCT-2007 the patient "passed out", for about 2 seconds. The patient was observed for 10 minutes and was okay, so she was sent home.The patient recoevered from her syncope episode. No additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass
Clinical narrative: Information has been received from a nurse concerning a female who was vaccinated intramuscularly with a 0.5 ml dose of Gardasil.  Subsequently the patient experienced a lump underneath the injection site.  Unspecified medical attention was sought.  At the time of the report the patient's outcome was unknown.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a 14 year old female who was vaccinated with an injection of her third dose of Gardasil.  Subsequently the patient experienced a fever one week after getting the third dose of Gardasil.  The patient's fever persisted and she sought unspecified medical attention.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Muscle atrophy, Pain, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a caucasian 23 year old female with a history of attention deficit/hyperactivity disorder, allergic reaction to Macrobid and an allergic reaction to Lorabid who on 29-Dec-2006 was vaccinated intramuscularly with her first dose of GARDASIL in the left arm (lot #654389/0961F).  Concomitant therapy included amphetamine aspartate/amphetamineSO4/dex (ADDERALL XR bid) and drospirenone (+) ethinyl estradiol (YASMIN).  On 02-May-2007 the patient was vaccinated intramuscularly with her second dose of GARDASIL in the left arm (lot #657617/0384U).  The patient complained of pain and throbbing during both injections.  On approximately 16-May-2007 the patient returned to the office with a dent with pain and ache in her left arm a few inches below the injection site.  On 10-Oct-2007 the patient was vaccinated intramuscularly with her third dose of GARDASIL in the right arm (lot #657617/0384U).  On 30-Nov-2007 the patient was seen by the orthopedist for the dent in her arm.  He feels it is muscle mass deterioration related to absorption of the GARDASIL.  The patient has not recovered.  The nurse also mentioned many other patients have had pain at the injection site. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Urticaria
Clinical narrative: Information has been received from a nurse concerning a 24 year old female who on 14-SEP-2007 was vaccinated intramuscularly with her first dose of Gardasil (lot# 658560/1062U). Concomitant therapy included hormonal contraceptives (unspecified) and ZYRTEC. On 15-SEP-2007 the patient experienced redness and pain at the injection site and hives on her arms and chest. The patient needed to use her inhaler (medication not specified) the next day. Subsequently, the patient recovered from redness and pain at the injection site and hives on her arm and chest. The patient sought medical attention with an office visit. Additional information has been requested. Additional information was received on 08-JAN-2008. The doctors office received the WAES letter and will fill out the information and send it back. Additional information has been requested.
Sex: F
Vaccine: HPV4, FLU3, HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a female with a history of ventricular septal defect and cardiac valve disease who on 02-DEC-2007 was vaccinated IM with the second dose of Gardasil.  Concomitant therapy included ZOLOFT.  On 03-DEC-2007 the patient experienced dizziness.  Subsequently, the patient recovered from her dizziness.  The reporter felt that dizziness was not related to therapy with Gardasil.  No further information was provided.  Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: HEP
Symptoms: Injection site pain, Pharmaceutical product complaint
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site pain in a 6-month-old subject of unspecified gender who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  On an unspecified date the subject received the 1st dose of Engerix B (.5 units not specified, unknown).  On an unspecified date, less than one day after vaccination with Engerix B, the subject experienced injection site pain.  The reporter stated that the needle "went into the subject, but when the nurse pulled the plunger out to aspirate, the entire plunger came out".  It was noted that the needle was still in the subject "when the unit fell apart" (product quality complaint).  The needle was removed, and the subject required re-administration of the vaccine.  At the time of reporting the outcome of the events was unspecified.  Follow-up information received on 04 June 2007 indicated that per the reporter, the medical assistant was correctly using the vaccine when the plunger fell out.  No additional detail was provided concerning the outcome of the event.
Age: 44.0
Sex: M
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  On an unspecified date the subject received an unspecified dose of Engerix B (unknown).  At an unspecified time after vaccination with Engerix B, the subject experienced not responding to therapy.  A registered nurse reported that she has a subject who was prescribed Engerix B to be given at a "non-responder dosage".  At the time of reporting the outcome of the event was unspecified.  Follow-up received on 09 July 2007 via the nurse indicated that the subject received the first dose of Engerix B on 18 October 2004, the second dose on 22 November 2004 and the third dose on 06 May 2005.  At an unspecified time after the completion of the series, it was noted that the subject did not respond to therapy.  The subject was given a fourth dose of Engerix B on 08 May 2007.
Sex: U
Vaccine: HEP
Symptoms: Decreased immune responsiveness
Clinical narrative: This case was reported by a physician and described the occurrence of low seroconversion to hepatitis B in a subject of unspecified age and gender who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  On an unspecified date the subject received unspecified dose of Engerix B (unknown).  At an unspecified time after vaccination with Engerix B, the subject experienced low seroconversion to hepatitis B vaccine.  At the time of reporting the outcome of the event was unspecified.
Age: 32.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antigen, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of decreased therapeutic response in a 33-year-old male subject who was vaccinated with Engerix B for prophylaxis.  On 5 January 2006, 13 February 2006, and 24 July 2006 the subject received the first, second, and third doses of Engerix B (unknown).  On 10 April 2007, approximately 9 months after the third vaccination with Engerix B, the subject experienced "possible nonresponse"/decreased therapeutic response in that the hepatitis B surface antigen titer was less than 3 mIU/mL.  The nurse indicated that it was unknown whether the subject was a "nonresponder" at the time of completion of the vaccination series, or if his antibody levels had "since waned".  At the time of reporting the event was unresolved.
Age: 10.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hives in a 10-year-old female subject who was vaccinated with hepatitis B vaccine (manufacturer unspecified) for prophylaxis.  On an unspecified date the subject received 1st dose of hepatitis B vaccine (unknown).  At an unspecified time after vaccination with hepatitis B vaccine, the subject experienced hives.  The subject was treated (not specified) in the doctor's office and the hives resolved after an unknown period of time.  No additional doses of hepatitis B vaccine were given due to the hives.  The healthcare professional considered the event was possibly related to vaccination with hepatitis B vaccine.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Laboratory test abnormal, No therapeutic response
Clinical narrative: This case was reported by a pharmacist and described the occurrence of a 51-year-old female subject not responding to therapy following vaccination with Engerix B (GlaxoSmithKline) for prophylaxis.  Concurrent medications included Ziac and Premarin.  On 18 July 2005 at 11:19 the subject received 4th dose of Engerix B in the right arm.  A negative titer was discovered in March 2007.  The subject had not responded to therapy.  At the time of reporting the outcome of the event was unspecified.  Follow-up information received on 22 May 2007 indicated that the subject had completed the three dose series of Engerix B with three vaccinations given on 10 August 2004, 08 February 2005 and the 3rd on 20 April 2005.  A 4th dose of Engerix B was given on 18 July 2005.  No additional information was provided.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody, Hepatitis B antibody negative
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in an adult female subject who was vaccinated with Engerix B vaccine (manufacturer unknown) for prophylaxis.  On unspecified dates the subject received unspecified doses of a complete Engerix B vaccine series (manufacturer unknown).  At an unspecified time after completing vaccination a Engerix B vaccine series, the subject was found to have lack of seroconversion.  The reporter noted that the subject had to have the series as a medical student, but was not sure which series the subject received.  At the time of reporting the outcome of the event was unspecified.  The healthcare professional considered the event was probably related to vaccination with Engerix B.  Follow-up information received later the same day of initial reporting indicated the dates of receipt of Engerix B.  The dates were 21 August 2003, 29 March 2003 and 28 February 2003.  A titer taken on 20 April 2007 indicated that the subject was not seroprotected following receipt of the Engerix B three dose series completed four years ago.  Follow-up information received on 14 May 2007 indicated that the reporter had limited information on this case as the subject was a student that requested a hepatitis titer as a requirement for continuing on at another school.  The subject has been lost to follow-up.  It was reported that the subject was 22 years old at the time the titer was performed.
Age: 12.0
Sex: F
Vaccine: HEP, TD
Symptoms: Injection site pain, Mobility decreased, Muscular weakness
Clinical narrative: This case was reported by a physician and described the occurrence of injection site pain in a 12-year-old female subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  The subject had no adverse events following receipt of prior immunizations and no relevant medical history.  There were no concurrent medications.  On 19 August 2003 the subject received unspecified dose of Engerix B (.5 ml, unknown) in the right arm.  On 19 August 2003, the subject also received a booster dose of Td adsorbed (Aventis Pasteur) in the left arm.  On 19 August 2003, less than one day after vaccination with Engerix B, the subject experienced injection site pain and arm weakness of the right arm.  The physician reported that the subject, "had to use her left arm to raise her right arm."  The physician reported that the "symptoms occurred intermittently and resolved after one year without treatment."  The vaccination course with Engerix B was discontinued.  The physician considered the events were probably related to vaccination with Engerix B.  Follow up information was received on 09 May 2007 via the physician, who reported that the subject had not previously received Engerix-B prior to the first administration on 19 August 2003.  The immunization series was discontinued, and the events resolved.  Upon follow-up, the physician indicated that the events were possibly related to vaccination with Engerix B.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hepatitis B surface antigen positive in a female subject of unspecified age who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  On 23 April 2007 at 3:00 p.m., the subject received 1st dose of Engerix B (20 mcg, unknown, right arm).  On 25 April 2007, 2 days after vaccination with Engerix B, the subject "tested positive for hepatitis B surface antigen."  At the time of reporting the outcome of the event was unspecified.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in an adult female subject who was vaccinated with Engerix B (manufacturer unknown) for prophylaxis.  On an unspecified date the subject received unspecified dose of Engerix B (20 mcg, unknown).  At an unspecified time after vaccination with Engerix B, the subject was tested and had no antibodies.  A registered nurse reported that her office provided the subject with a prescription to receive the adult series of vaccine for Engerix B; however, the subject received the Engerix B vaccine series at another unspecified location.  Thus, the reporting nurse does not know the manufacturer of the vaccine as the prescription was filled at a pharmacy.  The nurse considered the event was probably related to vaccination with Engerix B.  At the time of reporting the outcome of the event was unspecified.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Laboratory test abnormal, Therapeutic response decreased
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of decreased therapeutic response in a 22-year-old female subject who was vaccinated with hepatitis B vaccine (manufacturer unspecified) for prophylaxis.  On unspecified date(s), the subject received the series of three doses of hepatitis B vaccine.  At an unspecified time after completion of the vaccination series with hepatitis B vaccine, the subject experienced decreased therapeutic response.  The reporting nurse stated that the subject's hepatitis B antibody titers were "currently lower than what they should be and may need further immunization".  At the time of reporting the outcome of the event was unspecified.  Follow up information was received from the healthcare professional on 04 May 2007.  The healthcare professional indicated that she did not report this case to a regulatory authority.
Sex: M
Vaccine: HEP
Symptoms: Laboratory test abnormal, No therapeutic response
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of not responding to therapy in a male subject aged between 40 and 49 years old who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  On unspecified dates the subject received 3rd dose, 2nd dose and 1st dose of Engerix B.  Approximately five months after completing the series of three vaccinations with Engerix B, the subject had a titer for hepatitis B surface antibodies drawn and was found to have not responded to vaccination; the specific titer levels were not known by the reporter.  At the time of reporting, the physician was still determining whether he would give additional doses of the vaccine and the event was unresolved.  No further information available per the subject's physician.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Antibody test abnormal, Hepatitis B antibody, No therapeutic response
Clinical narrative: This case was reported by a physician and described the occurrence of not responding to therapy in a female subject of unspecified age who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  On an unspecified date the subject received 3rd dose, 2nd dose and 1st dose of Engerix B (unknown).  At an unspecified time after vaccination with Engerix B, the subject experienced not responding to therapy.  The subject stated that she had the hepatitis B series in the past but has no documentation to support this claim.  A random titer was drawn from the subject and the results "came back zero".  The physician stated that revaccination of the subject is planned.  At the time of reporting the outcome of the event was unspecified.  Follow-up information was received from the reporting physician on 24 April 2007.  The subject was 42 years old.  She was a social drinker and had never used tobacco.  The subject reported that she had received three "shots" for hepatitis B; however, a laboratory reported that her antibody level was "zero".  On 28 February 2007, hepatitis B surface antibody was "non reactive".  No details were available on the producer of the vaccine, and the lot number and the name of the vaccine were unknown.  The subject reported that she received the hepatitis B vaccine twice, but did not recall the dates of administration.  The subject was not sure that she had completed all three "shots" of each series.  The subject did not have a bad reaction to any of the vaccinations.  Per the reporter, the reason why the vaccine was ordered a second time was not known.  At the time of reporting, the subject had not experienced any adverse events.  The physician considered that the event could not have been associated with the subject's medical history/concurrent illness.  The physician reported that it was unknown if the event could have been associated with lack of efficacy or erroneous administration.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Eczema, Pruritus, Rash
Clinical narrative: This case was reported by a consumer and described the occurrence of rash in a 48-year-old female subject who was vaccinated with Engerix B for prophylaxis.  A physician or other health care professional has not verified this report.  In 1997 the subject received 3rd dose of Engerix B (unknown).  In October 2006, 9 years after vaccination with Engerix B, the subject developed a rash on her back, arms, chest, legs and sometimes her face.  The symptoms were described as a "red sunburn" with bumps that itch.  The subject was treated with topical steroids, xipamide (Aquaphor), allegra-d (Allegra D) and diphenhydramine hydrochloride (Benadryl) which helped the symptoms.  At the time of reporting the events were said to be worsening.  Follow-up information was received on 20 April 2007 via the consumer.  According to the subject, her allergist stated that any reaction to the vaccine would have been localized to the injection site.  The subject reported that she has eczema which is "completely unrelated" to the use of Engerix B.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody, Muscle spasms, Nausea, Swollen tongue, Vomiting
Clinical narrative: This case was reported by a consumer and described the occurrence of swelling of tongue in a 41-year-old female subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  A physician or other health care professional has not verified this report.  The subject's medical history included allergies to Prozac and penicillin.  There were no concurrent medications.  The subject previously received vaccinations, including influenza vaccine, without experiencing any adverse events.  On 2 April 2007, the subject received a dose of Engerix B (unknown).  This was the subject's 1st dose of Engerix B, but the 4th dose of hepatitis B vaccine.  The subject previously received the series of hepatitis B vaccine (unknown manufacturer) in 1995.  On 09 February 2007, the subject experienced not responding to therapy with Engerix B when she "was treated and the hepatitis B antibody was no longer present".  On 02 April 2007, the subject received a dose of Engerix-B.  After the Engerix B was administered, in the morning of 02 April 2007, the subject experienced nausea.  Later that same day, the subject reported her tongue was swelling, she was having leg cramps, and she "threw up" until 11 pm on 02 April 2007.  At the time of reporting the tongue swelling, nausea, and vomiting were unresolved.
Sex: F
Vaccine: HEP
Symptoms: Pruritus
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of itching in an adult female subject who was vaccinated with Engerix B for prophylaxis.  On 26 October 2006 the subject received 2nd dose of Engerix B in the right arm.  A few hours after receiving Engerix B, on 26 October 2006, the subject experienced itching on her neck, face and nose.  The subject received 50 mg diphenhydramine hydrochloride (Benadryl) the following day, on 27 October 2006, and the symptoms were relieved temporarily.  After a second, 50 mg dose of Benadryl taken 8 hours after the first, the event resolved.
Age: 0.6
Sex: M
Vaccine: DTAP, HBHEPB, HEP, PNC
Symptoms: Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hives in a 6-month-old male subject who was vaccinated with Engerix B (GlaxoSmithKline), Infanrix for prophylaxis.  The subject's medical history and concurrent conditions were not provided.  The subject had no known concurrent medications.  Previous and/or concurrent vaccination included Comvax; Merck given on 27 February 2006; Prevnar; Wyeth Labs given on 27 February 2006.  On 27 February 2006 the subject received 1st dose of Engerix B (unknown, right thigh, lot number reported as "ACHBCC6AA") and the 1st dose of Infanrix (unknown).  (A lot number that was given appears to be that of Infanrix; however, Infanrix was not mentioned in the subject's chart.)  At an unspecified time after vaccination with Engerix B and Infanrix, the subject experienced hives.  The reporter, a nurse, was calling from an allergist's office.  They were trying to determine the causative allergen of the hives.  The Engerix B immunization series was delayed and discontinued.  At the time of reporting, the hives resolved.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Body temperature, Dizziness
Clinical narrative: This case was reported by a physician and described the occurrence of dizziness in a 32-year-old female subject who was vaccinated with Engerix B for prophylaxis.  Concurrent medication included an unknown diet medication (Diet Pill).  On 27 February 2007 at 11:15 the subject received 3rd dose of Engerix B, intramuscularly, in the left deltoid.  About 85 minutes after vaccination with the 3rd dose of Engerix B, the subject experienced dizziness.  At the time of reporting the event was resolved.  Follow-up information was received on 10 April 2007 via a physician, who reported that the subject received her 1st dose of Engerix B on 08 March 2006, and her 2nd dose of Engerix B on 05 April 2006.  In addition, the physician stated that the dizziness lasted for approximately 30 minutes and may not have been related to the Engerix B injection.  After receiving fluids (unspecified) and rest, the symptoms improved.  The subject has no history of alcohol or tobacco use.  The physician indicated that the subject's medical history and/or concurrent illness of dehydration may have been associated with the event.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of positive serology for hepatitis B surface antigen in a 46-year-old female subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  On 3 March 2007 at 11:10 the subject received 1st dose of Engerix B (two lot numbers provided: AHBVB260, AHBVB2878) at 40 mcg, intramuscularly, in the right arm.  On 6 March 2007, 3 days after vaccination with Engerix B, the subject experienced positive serology for hepatitis B surface antigen.  At the time of reporting the outcome of the event was unspecified.
Sex: M
Vaccine: HEP
Symptoms: Activities of daily living impaired, Developmental delay, Learning disability, Learning disorder, Mental disorder
Clinical narrative: This case was reported by a lawyer and described the occurrence of nerve damage in a male subject of unspecified age (identified as "minor child") who was possibly vaccinated with hepatitis B vaccine (manufacturer unspecified) and/or Tdap for prophylaxis.  A physician or other health care professional has not verified this report.  The legal complaint alleged that the subject was exposed to airborne mercury vapor and mercury through the food chain.  Concomitant medications and/or vaccinations were not specified.  According to the complaint, subject experienced mercury exposure from products including but not limited to hepatitis B vaccine and/or Tdap, in addition to mercury exposure from other products and via the environment.  The complaint alleged that as a result of "toxic mercury exposure", the minor child experienced "serious and permanent neurological damage.  Said damages include past and future mental, intellectual, developmental, and neurological incapacity and associated learning disabilities, disorders, and impairments."  Additionally, the complaint alleged that the subject "has suffered and will suffer in the future impairment of enjoyment and loss of quality of life and other injuries".  At the time of reporting the outcome of the events was unspecified.
Sex: M
Vaccine: HEP
Symptoms: Mental impairment, Metal poisoning, Nerve injury
Clinical narrative: This case was reported by a lawyer and described the occurrence of nerve damage in a male subject of unspecified age (identified as "minor child") who was possibly vaccinated with hepatitis B vaccine (manufacturer unspecified) and/or Tdap for prophylaxis.  A physician or other health care professional has not verified this report.  The legal complaint alleged that the subject was exposed to airborne mercury vapor and mercury through the food chain.  Concomitant medications and/or vaccinations were not specified.  According to the complaint, subject experienced mercury exposure from products including but not limited to hepatitis B vaccine and/or Tdap, in addition to mercury exposure from other products and via the environment.  The complaint alleged that as a result of "toxic mercury exposure", the minor child experienced "serious and permanent neurological damage.  Said damages include past and future mental, intellectual, developmental, and neurological incapacity and associated learning disabilities, disorders, and impairments."  Additionally, the complaint alleged that the subject "has suffered and will suffer in the future impairment of enjoyment and loss of quality of life and other injuries".  At the time of reporting the outcome of the events was unspecified.
Sex: M
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a physician and described the occurrence of a male subject aged between 60 and 69 years old testing hepatitis b antibody negative following vaccination with a complete series of Engerix B for prophylaxis.  On 2 March 2007 the subject completed his three dose series of Engerix B (unknown).  The 3rd dose was given, 20mcg in the deltoid of each arm.  At an unspecified time after completion of the Engerix B series, the subject was tested on 05 March 2007 and found to be positive for surface antigens.  The subject was tested again on 10 March 2007 and was negative for surface antigens.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antigen negative, No therapeutic response
Clinical narrative: This case was reported by a physician and described a 21-year-old female subject who did not respond to immunization with Engerix B for prophylaxis.  The subject received her first, second, and third dose of Engerix B on 29 September 1999, 29 October 1999, and 12 April 2000 respectively.  On 23 February 2007, approximately 7 years after her third vaccination with Engerix B, random titer results which included hepatitis B surface antibody titer were negative.  Follow-up was received from reporting physician on 09 April 2007.  The subject was reported to be in good health.  The subject's diagnosis was reported as "no detectable titer on 23 March 2007".  The lot number of Engerix B was reported as 3075A2 0098 SKB.  The physician considered the event was related to vaccination with Engerix B.  He indicated the event was not serious, but considered that it jeopardized the subject or required intervention.  The immunization series with Engerix B was not discontinued or delayed.  At the time of reporting, the event was unresolved.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antigen negative, No therapeutic response
Clinical narrative: This case was reported by a pharmacist and described the occurrence of an adult female subject not responding to therapy following vaccination with Engerix B for prophylaxis.  Concurrent medications included Fish oil.  On an unspecified date the subject received 3rd dose, 2nd dose and 1st dose of Engerix B (unknown).  At an unspecified time after vaccination with Engerix B, the subject was tested and found to not be responding to therapy and therefore experiencing lack of effect.  At the time of reporting the outcome of the events was unspecified.