chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
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 an adult male subject who was vaccinated with Engerix B for prophylaxis.  Concurrent medical conditions included dialysis.  The subject had no allergies.  Concurrent medications included Multiple unspecified medications.  On 12 February 2007 the subject received the 1st dose of Engerix B (40 mcg, unknown).  Two days after vaccination with Engerix B, blood work was completed.  On 15 February 2007, 3 days after vaccination with Engerix B, the subject was found to be hepatitis b surface antigen positive.  Previously, the subject was hepatitis b surface antigen negative.  At the time of reporting the event was unresolved.  The healthcare professional considered the event was probably related to vaccination with Engerix B.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive, Vaccination failure
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hepatitis b surface antigen positive in an adult male subject who was vaccinated with Engerix B for prophylaxis.  Concurrent medical conditions included dialysis and shellfish allergy.  Concurrent medications included Multiple unspecified medications.  On 12 February 2007 the subject received the 1st dose of Engerix B (40 mcg, unknown, unknown arm).  On 14 February 2007, 2 days after vaccination with Engerix B, blood work was completed, and the subject was found to be hepatitis b surface antigen positive.  Previously, the subject had been hepatitis b surface antigen negative.  At the time of reporting the event was unresolved.  The healthcare professional considered the event was probably related to vaccination with Engerix B.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive, Vaccination failure
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hepatitis b surface antigen positive in an adult female subject who was vaccinated with Engerix B for prophylaxis.  Concurrent medical conditions included dialysis and penicillin allergy.  Concurrent medications included Multiple unspecified medications.  On 13 February 2007 the subject received the 1st dose of Engerix B (40 mcg, unknown, unknown arm).  On 15 February 2007, 2 days after vaccination with Engerix B, blood work was completed, and the subject was found to be hepatitis b surface antigen positive.  Previously, the subject was hepatitis b surface antigen negative.  At the time of reporting the event was unresolved.  The healthcare professional considered the event was probably related to vaccination with Engerix B.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive, Vaccination failure
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hepatitis b surface antigen positive in an adult female subject who was vaccinated with Engerix B for prophylaxis.  The subject's medical history included dialysis.  The subject had no allergies.  Concurrent medications included Multiple unspecified medications.  On 12 February 2007 the subject received the 1st dose of Engerix B (40 mcg, unknown, unknown arm).  On 14 February 2007, 2 days after vaccination with Engerix B, blood work was drawn, and the subject was found to be hepatitis b surface antigen positive.  At the time of reporting the event was unresolved.  The healthcare professional considered the event was probably related to vaccination with Engerix B.
Sex: M
Vaccine: HEP
Symptoms: Diarrhoea, Faeces discoloured
Clinical narrative: This case was reported by a consumer and described the occurrence of diarrhea in a male subject aged between 60 and 69 years old who was vaccinated with Engerix B for prophylaxis.  The reporter is the subject.  A physician or other health care professional has not verified this report.  The subject had no pre-existing medical conditions.  There were no concurrent medications.  On an unspecified date before 29 November 2006, the subject received the 2nd dose of Engerix B.  At an unspecified time after vaccination with the 2nd dose of Engerix B, on an unspecified date before 29 November 2006, the subject experienced diarrhea and stool color change from "brown to yellow."  On 29 November 2006, the subject received 3rd dose of Engerix B.  The subject was seen at a physician's office.  At the time of initial reporting, 19 February 2007, the subject reported that the diarrhea had improved and that he is "now having one firm stool in the morning and then diarrhea later in the day."  The outcome of the stool color change was not reported.  Follow-up information was received from the subject on 20 February 2007.  The subject reported that he was advised to have a liver function test.  He called to report that his liver function test was "fine".  He reported: "I have a good liver".
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody, No therapeutic response
Clinical narrative: This report was reported by a pharmacist and described the occurrence of not responding to therapy in an adult subject of unspecified gender who was vaccinated with ENGERIX-B (GlaxoSmithKline) for prophylaxis. On an unspecified date on or before 16 February 2007, the subject received 3rd dose of Engerix-B. At an unspecified time after vaccination with Engerix-B, on an unspecified date on or before 16 February 2007, a hepatitis B surface antibody titer was negative. The pharmacist considered the event was probably related to vaccination with Engerix-B.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody, No therapeutic response
Clinical narrative: This case was reported by a pharmacist and described the occurrence of not responding to therapy in an adult subject of unspecified gender who was vaccinated with Engerix B for prophylaxis.  On an unspecified date on or before 16 February 2007, the subject received 3rd dose of Engerix B.  At an unspecified time after vaccination with Engerix B, on an unspecified date on or before 16 February 2007, a hepatitis B surface antibody titer was negative.  The pharmacist considered the event was probably related to vaccination with Engerix B.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody, Hepatitis B antibody negative, No therapeutic response
Clinical narrative: This case was reported by a pharmacist and described the occurrence of not responding to therapy in an adult subject of unspecified gender who was vaccinated with Engerix-B (GlaxoSmithKline) for prophylaxis.  On an unspecified date on or before 16 February 2007, the subject received 3rd dose of Engerix-B.  At an unspecified time after vaccination with Engerix-B, on an unspecified date on or before 16 February 2007, a hepatitis B surface antibody titer was negative.  The pharmacist considered the event was probably related to vaccination with Engerix-B.  The pharmacist reported that two other subjects did not respond to immunization to Engerix-B.  Please see cases A0639944A and A0639945A.
Sex: M
Vaccine: HEP
Symptoms: Developmental delay, Immune system disorder, Metal poisoning, Nervous system disorder, Psychomotor skills impaired
Clinical narrative: This case was reported by a lawyer and described the occurrence of toxic effect of mercury and its compounds in a male child 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, concurrent conditions, and concurrent medications were not reported. On 30 March 1998 the subject received 1st dose of Engerix-B (10 mcg, intramuscular). During the first 15 months of life, on or after 30 March 1998 and on or before 15 July 1999, the subject also received vaccinations with RECOMBIVAX, TriHIBit, ACEL-IMMUNE, HibTITER, and MMR II vaccine. According to the legal complaint, the subject was subjected to very high doses of mercury from thimerosal-containing vaccines during the first 15 months of life. As a result of the mercury contained in the thimerosal-containing vaccinations, the subject suffers from neurological and immunological damage with symptoms including developmental delay, loss of language, and failure to meet certain social and motor milestones. The outcome of the events was not reported.
Sex: M
Vaccine: HEP
Symptoms: Speech disorder
Clinical narrative: This case was reported by a lawyer and described the occurrence of toxic effect of mercury and its compounds in a male child 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, concurrent conditions, and concurrent medications were not reported. On 30 March 1998 the subject received 1st dose of Engerix-B (10 mcg, intramuscular). During the first 15 months of life, on or after 30 March 1998 and on or before 15 July 1999, the subject also received vaccinations with RECOMBIVAX, TriHIBit, ACEL-IMMUNE, HibTITER, and MMR II vaccine. According to the legal complaint, the subject was subjected to very high doses of mercury from thimerosal-containing vaccines during the first 15 months of life. As a result of the mercury contained in the thimerosal-containing vaccinations, the subject suffers from neurological and immunological damage with symptoms including developmental delay, loss of language, and failure to meet certain social and motor milestones. The outcome of the events was not reported.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Sinusitis bacterial, Upper respiratory tract infection
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of chills in a 43-year-old female subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  The subject's medical history included sinus infection in September 2006 treated with Avelox.  Concurrent medical conditions included anxiety depression, celiac disease and hepatitis C (date of diagnosis unknown).  Concurrent medications included Fioricet and Xanax.  On an unspecified date the subject received the 1st dose of Engerix B (1 ml, unknown).  At an unspecified time after vaccination with Engerix B, the subject experienced chills, bacterial sinusitis and upper respiratory symptoms.  The upper respiratory illness was diagnosed as a bacterial sinus infection and was initially treated with penicillin.  The bacterial sinus infection proved to be resistant to penicillin, and the subject was then started on Levaquin.  It was unclear if the subject was responding to Levaquin.  At the time of reporting the outcome of the events was unspecified.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, 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.  Concurrent medical conditions included dialysis.  Subjects had previously received Recombivax and did not respond to therapy.  On an unspecified date the subject received unspecified dose of Engerix B (unknown).  At an unspecified time after vaccination with Engerix B, the subject did not respond to therapy as laboratory results did not show anti-hepatitis B antibodies.  At the time of reporting the outcome of the event was unspecified.  The nurse reported that this occurred in a total of eight patients.  GSK case numbers are A0638778A and A638780A through A0638786A.
Sex: U
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). Concurrent medical conditions included dialysis. Subjects had previously received Recombivax and did not respond to therapy. On an unspecified date the subject received unspecified dose of Engerix B (unknown). At an unspecified time after vaccination with Engerix B, the subject did not respond to therapy as laboratory results did not show anti-hepatitis b antibodies. At the time of reporting the outcome of the event was unspecified. The nurse reported that this occurred in a total of eight patients. GSK case numbers are A0638778A and A638780A through A0638786A.
Sex: U
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 hepatitis B vaccine (Engerix B, GlaxoSmithKline) for prophylaxis. Concurrent medical conditions included dialysis. Subjects had previously received Recombivax and did not respond to therapy. On an unspecicifed date the subject received unspecified dose of Engerix B (unknown). At an unspecified time after vaccination with Engerix B, the subject did not respond to therapy as laboratory results did not show anti-hepatits b antibodies. At the time of reporting the outcome of the event was unspecified.
Sex: U
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). Concurrent medical conditions included dialysis. Subjects had previously received Recombivax and did not respond to therapy. On an unspecified date the subject received unspecified dose of Engerix B (unknown). At an unspecified time after vaccination with Engerix B, the subject did not respond to therapy as laboratory results did not show anti-hepatitis b antibodies. At the time of reporting the outcome of the event was unspecified. The nurse reported that this occurred in a total of eight patients. GSK case numbers are A0639778A and A638780A through A0638786A.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, 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.  Concurrent medical conditions include dialysis.  Subjects had previously received Recombivax and did not respond to therapy.  On an unspecified date the subject received unspecified dose of Engerix B (unknown).  At an unspecified time after vaccination with Engerix B, the subject did not respond to therapy as laboratory results did not show anti-hepatitis B antibodies.  At the time of reporting the outcome of the event was unspecified.  The nurse reported that this occurred in a total of eight patients.  GSK case numbers are A0638778A and A0638780A through A0638786A.
Sex: U
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 unspecicifed age an gender who was vaccinated with ENGERIX B (GlaxoSmithKline) for prophylaxis. Concurrent medical conditions included dialysis. Subjects had previously received Recombivax and did not respond to therapy. On a unspecified date the subject received unspecified dose of Engerix B (unknown). At an unspecified time after vaccination with Engerix B, the subject did not respond to therapy as laboratory results did not show anti-hepatitis b antibodies. At the time of reporting the outcome of the event was unspecified.
Sex: U
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 for prophylaxis. Concurrent medical conditions included dialysis. Subjects had previously received Recombivax and did not respond to therapy. On an unspecified date the subject received unspecified dose of Engerix B (unknown). At an unspecified time after vaccination with Engerix B, the subject did not respond to therapy as laboratory results did not show anti-hepatitis b antibodies. At the time of reporting the outcome of the event was unspecified.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, 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.  Concurrent medical conditions included dialysis.  Subjects had previously received Recombivax and did not respond to therapy.  On an unspecified date the subject received unspecified dose of Engerix B (unknown).  At an unspecified time after vaccination with Engerix B, the subject did not respond to therapy as laboratory results did not show anti-hepatitis B antibodies.  At the time of reporting the outcome of the event was unspecified.  The nurse reported that this occurred in a total of eight patients.  GSK case numbers are A0638778 and A0638780A through A0638786A.
Age: 2.0
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B, Vaccination failure
Clinical narrative: This case was reported by a healthcare professional, via a sales representative, and described the occurrence of hepatitis b in two and a half-year-old subject of unspecified gender who was vaccinated with hepatitis B vaccine (manufacturer unspecified) for prophylaxis. On an unspecified date, the subject completed the primary course of Hepatitis B vaccine (unknown) during infancy. At an unspecicifed time after vaccination with Hepatitis B vaccine, the subject experienced lack of effect and was "recently" diagnosed with Hepatitis B. At the time of reporting the outcome of the events was unspecified. The subject was sent to the Health Department by his/her physician with the request for the subject to receive another Hepatitis b vaccine series.
Age: 48.0
Sex: M
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 48-year-old male subject who was vaccinated with Engerix-B (GlaxoSmithKline) for prophylaxis.  The subject's medical history included hemodialysis and hepatitis C.  Concurrent medications included blood pressure medication and anti-hypercholesterolaemic (cholesterol reducing agent name not known).  On 15 January 2007 the subject received 1st dose of Engerix-B.  On 17 January 2007, 2 days after vaccination with Engerix-B, a hepatitis B surface antigen test was positive.  The outcome of the event was not reported.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Influenza like illness
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a female patient between 14 and 16 year old who was vaccinated with a second dose of Gardasil. The reporter mentioned that patient's mother called in to report she was experiencing flu like symptoms. She received the dose of Gardasil 2 weeks earl. It was unknown if patient sought medical attention, the outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Syncope
Clinical narrative: Information has been received from a physician concerning patients who were vaccinated with Gardasil. Subsequently the patients experienced fainting and nausea. The nurse indicated at least 5 patients experienced fainting and nausea. The nurse indicated at least 5 patients have had this experience. They did not eat before receiving the vaccination. The patient's sought unspecified medical attention and their outcome was not reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Blood human chorionic gonadotropin, Blood urine present, Drug exposure during pregnancy, Ultrasound abdomen normal
Clinical narrative: Information has been received from a consumer concerning her 16 year old daughter who on approximately 15-AUG-2007 "two months ago" was vaccinated with a dose of Gardasil. There was no concomitant medication. The consumer was not sure whether it was her daughter's first or second dose. It was reported that her daughter is currently four months pregnant (approximate LMP 15-JUN-2007). Her pregnancy was confirmed by a pregnancy test. Unspecified medical attention was sought. At the time of this report, the patient had not recovered. No product quality complaint was involved. Follow up information indicated that the patient had back pain starting on 26-NOV-2007 and also urinated a little bit of blood. She went to the emergency room on 27-NOV-2007 and was checked to see if she was having any contractions and sent her home. No ultrasound was done at that time. An ultrasound was done on 05-NOV-2007 and the baby was moving and another ultrasound was scheduled for 14-DEC-2007. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy
Clinical narrative: Information has been received through the Merck pregnancy registry through a nurse concerning a 26 year old female who on 03-APR-2007 was vaccinated with her first dose of GARDASIL. On 07-JUN-2007, the patient was vaccinated with her second dose of GARDASIL. On 27-SEP-2007 the patient was vaccinated with her third dose of GARDASIL. Subsequently, it was determined that the patient was pregnant (LMP = 23-SEP-2007, also reported as 27-SEP-2007). No adverse reactions were reported. This is a consolidation of two reports. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a health professional concerning a female (age not reported) who on an unspecified date was vaccinated IM with a dose of Gardasil (lot #, site of administration not reported). Immediately after vaccination, the patient experienced moderate inflammation at the site of injection characterised by redness, warmth and pain. Subsequently the patient experienced axillary adenopathy. At the time of the report, the duration of the events and the outcome of was not reported. Other business partner numbers include: E2007-07547. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from a health professional concerning a female (age not reported) who on an unspecified date was vaccinated IM with a dose of Gardasil (lot #, site of administration not reported). Immediately after vaccination, the patient experienced moderate inflammation at the site of injection characterised by redness, warmth and pain. Subsequently the patient experienced axillary adenopathy. At the time of the report, the duration of the events and the outcome of was not reported. Other business partner numbers include: E2007-07547. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Contusion, Erythema, Hypoaesthesia, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a physisican concerning a female in her "early twenties" who was vaccinated with her third dose of GARDASIL (lot# unspecified). There was no concomitant medication. Sometime during the last week of November 2007, the patient experienced pain down her arm that later morphed into numbness down her hand. The patient's outcome was not reported. No further information is available. 02/10/2010 On 26-Nov-2007, the patient reported shooting pain down left arm from left shoulder with numbness in her left hand lasting 3 hours. Since then has reported intermittent left hand numbness and left arm pain. Left arm pain and left arm has significant redness, swelling and bruising. A C-spine x-ray was performed on 01-Dec-2007, and the report listed no acute fracture or dislocation. The neural formained and spinal canal were of normal size. The alignment of the cervical vertbrae was within normal limits.  No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Spinal X-ray normal
Clinical narrative: Information has been received from a physisican concerning a female in her "early twenties" who was vaccinated with her third dose of GARDASIL (lot# unspecified). There was no concomitant medication. Sometime during the last week of November 2007, the patient experienced pain down her arm that later morphed into numbness down her hand. The patient's outcome was not reported. No further information is available. 02/10/2010 On 26-Nov-2007, the patient reported shooting pain down left arm from left shoulder with numbness in her left hand lasting 3 hours. Since then has reported intermittent left hand numbness and left arm pain. Left arm pain and left arm has significant redness, swelling and bruising. A C-spine x-ray was performed on 01-Dec-2007, and the report listed no acute fracture or dislocation. The neural formained and spinal canal were of normal size. The alignment of the cervical vertbrae was within normal limits.  No further information is available.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Dysgeusia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of bad taste mouth in a 40-year-old female subject who was vaccinated with Engerix-B (GlaxoSmithKline) for prophylaxis.  On 17 November 2006 at 3:15 p.m., the subject received 3rd dose of Engerix-B in the left deltoid.  On 17 November 2006 at 3:15 p.m., immediately after vaccination with Engerix-B, the subject experienced bad taste in her mouth.  The reporter stated that the subject, "did not experience this reaction with her previous (two) doses."  On 17 November 2006, the subject also received 2nd dose of Havrix (GlaxoSmithKline).  The exact time of administration of Havrix was not reported.  The outcome of the event was not reported.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antigen positive, Hepatitis B surface antigen positive, Vaccination failure
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of a male subject of unspecified age testing hepatitis B antigen positive following vaccination with Engerix B for prophylaxis. On unspecified dates the subject received 1st and 2nd doses of Engerix-B. At an unspecified time after the 2nd vaccination with Engerix-B, the subject tested hepatitis B antigen positive. He had no symptoms of hepatitis and his liver enzymes were normal. Prior to receiving Engerix-B, the subject was hepatitis B antigen negative. Follow-up was received from the reporting healthcare professional. The subject received the 1st dose of Engerix-B on 06 November 2006. On 08 November 2006, two days after receipt of the 1st dose of Engerix B, a hepatitis B surface antigen test was positive. On 10 November 2006, a repeat hepatitis B surface antigen test was again positive. On 16 November 2006, the subject was again retested with "a different lab" and was hepatitis B surface antigen negative. The healthcare professional stated that the subject tested positive for hepatitis B surface antigen due to "lab error, not because of the vaccine."
Sex: F
Vaccine: HPV4
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a dose of Gardasil (lot# unspecified).  The physician was informed that the patient had a reaction to a recent dose of the vaccine.  No diagnostic laboratory studies were performed.  No details of the reaction were available at this time.  Additional information has been requested. 04/07/2008 Follow-up information was received by the physician who reported that the vaccination was given by the pediatrician. No further information is expected.
Age: 65.0
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered, Laboratory test normal, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of a 65-year-old male subject not responding to therapy following vaccination with Engerix B (GlaxoSmithKline). The subject completed his initial Engerix B series in 2000. Following an "exposure" the subject was  tested and his titer came back negative. On 27 November 2006 at 15:40 the subject received a 4th dose of Engerix B at 10 mcg. This was considered to be an inappropriate dose of Engerix B. The subject should have received the adult dose of Engerix B at 20 mcg as indicated. No adverse events were reported.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Joint sprain, Joint swelling, Laboratory test, Subcutaneous nodule
Clinical narrative: Information has been received from the father of a 16 year old female consumer with no medical history and/or drug reactions/allergies who on 04-Sep-2007 was vaccinated IM with the first 0.5 mL dose of Gardasil (lot not reported).  There was no concomitant medication.  During the first part of October, 2007, the patient experienced swollen ankle.  The patient went to the ER and was diagnosed with ankle sprain.  "A couple of days later" her other ankle swelled.  At the time of the report the patient was experiencing pain in her ankles, knees, hips, elbows and wrists and she has "subcutaneous nodules" on her arms and legs."  Unspecified blood work was performed (results not provided).  At the time of the report the patient was recovering.  There was no product quality complaint.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/7/2008. Information has been received from the father of a 16 year old female (119 lbs., 62 inches) with no medical history and/or drug reactions/allergies who on 04-SEP-2007 was vaccinated IM with the first 0.5 mL dose of GARDASIL vaccine (Lot #657872/0515U). There was no concomitant medication. During "the first part of October, 2007, the patient experienced swollen ankle. The patient went to the ER and was diagnosed with ankle sprain. "A couple of days later" her other ankle swelled. At the time of the report the patient was experiencing pain in her ankles, knees, hips, elbows and wrists and she has "subcutaneous nodules" on her arm and legs." Unspecified blood work was performed (results not provided). The patient recovered from her experiences on 17-DEC-2007. No further information is expected.
Age: 63.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antigen positive
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of a 63-year-old male subject testing hepatitis B antigen positive following vaccination with Engerix B (GlaxoSmithKline) for prophylaxis.  Concurrent medications included Zemplar, allopurinol, Nexium, Serevent, Colace, Epodil, thalidomide, VFEND, albuterol, Singulair, Kytril, lorazepam, EPO, and Renagel.  On 21 October 2006 the subject received 1st dose of Engerix B, two 20 mcg injections, one in each arm (40 mcg, intramuscularly).  In September 2006, the subject tested hepatitis antigen negative.  On 24 October 2006, the subject had a positive antigen test result.  The subject had a negative test result again on 02 November 2006.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site discolouration
Clinical narrative: Information has been received from a medical assistant concerning a 19 year old female with no medical history and no known drug reactions or allergies who on 22-MAY-2007 was vaccinated with the first dose of Gardasil. On 23-July-2007 the patient was vaccinated with the second dose of Gardasil. And on 21-Nov-2007 the patient was vaccinated with the third dose of Gardasil (Lot # 0530U). Concomitant therapy included LOESTRIN. On 21-NOV-2007 the patient developed a white spot at injection site. At the time of reporting the patient had not recovered. No laboratory diagnostic tests were performed. Unknown medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site bruising, Injection site mass, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning her 16 year old daughter, with a history of seasonal allergy and no other pertinent medical history who on 28-NOV-2007 was vaccinated subcutaneously in the arm with a dose of GARDASIL. On 29-NOV-2007 the patient's arm hurt and it was bruised with a lump on the arm where she was vaccinated. Unspecified medical attention was sought. The patient recovered on 02-DEC-2007. No diagnostic laboratory tests were performed. No product quality complaint was involved. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Information has been received from a nurse concerning a 21 year old female who on 08-OCT-2007 was vaccinated with a dose of Gardasil (lot # 657005/0314U). Concomitant therapy included hormonal contraceptives (unspecified). On 08-OCT-2007 the patient experienced redness, swelling and water blisters around the injection site. The patient's status was not reported. There was no product quality complaint involved. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Nausea, Paraesthesia
Clinical narrative: Information has been received from a health care professional concerning an 18 year old white female college student weighing 165 pounds and height of 5' 3" with a history of asthma and no known drug allergies or illnesses at time of vaccination who on 21-NOV-2007 was vaccinated in the left deltoid with the first dose of Gardasil (lot # 658100/0525U). It was reported that within 5 minutes after vaccination, the patient complained of nausea and dizziness. The patient had stood up. The patient was told to stay seated and was given cold compresses on back of neck and head and was told to lower her head. The patient was also given water and crackers. After 30 minutes the patient was allowed to go home. The patient also complained of left hand tingling after 5 to 10 minutes of vaccination. The patient recovered on 21-NOV-2007. No laboratory diagnostic tests were performed. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Pallor
Clinical narrative: Information has been received from a physician concerning an 18 year old female who was vaccinated with a dose of Gardasil.  The patient became pale and lightheaded.  Subsequently, the patient recovered from pale and lightheaded.  Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis A antibody positive, Hepatitis B surface antigen negative, Hepatitis B surface antigen positive
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of a 72-year-old female subject testing hepatitis b antigen positive following vaccination with ENGERIX B (GlaxoSmithKline) for prophylaxis. Concurrent medications included phoslo, paricalcitol, unknown medication (Sensepur), erythropoientin, nifedipine, linsinopril, TUMS, nephrocaps, lipitor and enteric-coated aspirin. On 24 October 2006 the subject received 1st dose of Engerix B, two 20 mcg injections intramuscularly in the left arm. (40 mcg, intramuscularly). On 26 September 2006 and 24 October 2006, the subject tested hepatitis antigen negative. On 28 November 2006, the subject tested hepatitis antigen positive.
Sex: F
Vaccine: HPV4
Symptoms: Rash vesicular, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a female in 2007 who was vaccinated with a first dose of Gardasil (lot# unknown). On an unspecified date, the patient experienced a fainting episode. On 05-DEC-2007, the patient was vaccinated with a second dose of Gardasil. On an unspecified date the patient developed shingles like rash. The rash broke out on her face a few days later. Medical attention was sought. At the time of reporting the patient had not recovered. No further information is available.
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: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test positive, Smear cervix abnormal, Syncope
Clinical narrative: Information has been received from a licensed practical nurse concerning a 19 year old female with seizure disorder, asthma, a papanicolaou smear with epithelial abnormality and cellular changes suggestive of HPV on 15-Mar-2007, and a papanicolaou smear that was negative two years earlier, who on 15-Mar-2007 was vaccinated intramuscularly with a 0.5mL first dose of Gardasil (Lot #654535/0960F).  On 21-Jun-2007 the patient was vaccinated with a second dose of Gardasil (Lot #655617/1447F).  On 13-Sep-2007 the patient was vaccinated with a third dose of Gardasil (Lot #655205/1426F).  Concomitant therapy included albuterol inhaler as needed and a seizure disorder medication (therapy unspecified) that was stopped on an unknown date by the patient before the pregnancy.  On 13-Sep-2007 a urine pregnancy test was taken and was negative.  On 15-Oct-2007 the patient experienced a syncopal episode and a urine pregnancy test was negative.  On 25-Nov-2007 the patient was seen in the office and a urine pregnancy test was positive.  The patient's last menstrual period was 15-Oct-2007 and her estimated delivery date was 21-Jul-2007.  At the time of the report, the outcome of the patient was unknown.  No product quality complaint was involved.  Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in an adult subject of unspecified gender who was vaccinated with Engerix-B (GlaxoSmithKline). The healthcare professional reported that more than one subject did not respond to immunization to Engerix-B, however a specific number of subjects was not reported. On an unspecified date on or before 11 December 2006, the subject received unspecified dose of Engerix-B. At an unspecified time after vaccination with Engerix-B, on an unspecified date on or before 11 December 2006, a hepatitis B surface antibody titer indicated that the subject "did not respond to Engerix-B." The subject was seen by a physician.
Age: 23.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: 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 23-year-old male subject who was vaccinated with Engerix B, Twinrix, and Havrix for prophylaxis. On 19 September 2006, 28 March 2006 and 24 January 2006 the subject received 3rd dose, 2nd dose and 1st dose of Engerix B (1 ml, unknown). On an unspecified date the subject received unspecified dose of Twinrix (unknown). On 19 September 2006, 28 March 2006 and 24 January 2006 the subject received 3rd dose, 2nd dose and 1st dose of Havrix (unknown). At an unspecified time after vaccination with Engerix B, Havrix and Twinrix, the subject experienced not responding to therapy. The physician reported that the surface antibody was negative as well as the core antibody. Relevant test results included  [laboratory results/hospital investigations]. At the time of reporting the outcome of the event was unspecified.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Mass, Oedema peripheral, Pruritus, Swelling face
Clinical narrative: Information has been received from a nurse practitioner concerning a 25 year old female, who on 19-NOV-2007 was vaccinated with a first dose of Gardasil (Lot# 654539/0742U). On 20-NOV-2007 the patient developed red lumps on her face. The patient was advised to take BENADRYL. On 24-NOV-2007 the patient still was not recovered and went to the emergency room where she received steroids. The patient was advised to receive the second and third dose of Gardasil. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/7/2008. Initial and follow-up information had been received from a nurse practitioner concerning a 25 year old female, who on 19-NOV-2007 was vaccinated intramuscularly in the right deltoid with a first dose of GARDASIL (Lot# 654539/0742U). There was no illness at the time of the vaccination. On 20-NOV-2007 the patient developed pruritic red lumps on her face, hands, and upper body. There was no shortness of breath, and no swelling. The patient was advised to take BENADRYL. On 24-NOV-2007 the patient developed swelling of face and hands. The patient still was not recovered and went to the emergency room with no relief from BENADRYL. The patient was given "steroids for 5 days." The patient was advised to receive the second and third dose of GARDASIL. On 26-NOV-2007 the patient recovered. No product quality complaint was involved. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 14 year old female who on 17-NOV-2007 was vaccinated with Gardasil and has had injection site pain since then.  Onset of injection site pain was also reported as 13-JAN-2007.  Medical attention was sought, patient called nurse practitioner.  Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a pharmacist and described the occurrence of not responding to therapy in an adult subject of an unspecified gender who was vaccinated with Engerix B for prophylaxis.  On unspecified dates, the subject received the 1st, 2nd, and 3rd dose of Engerix B (unknown).  At an unspecified time after vaccination with Engerix B, the subject did not respond to therapy.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site bruising, Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a physician concerning a 16 year old female with no pertinent medical history and no drug reaction/allergies who on 17-JAN-2007 was vaccinated with her first dose of GARDASIL. Concomitant therapy included pantoprazole sodium (PROTONIX). On 20-MAR-2007 the patient received her second dose of GARDASIL (lot# 653736/0014U) subcutaneously, 0.5ml once. After receiving the second dose subcutaneously the patient had an injection site reaction. The reaction consisted of pain and bruising at the injection site. No laboratory studies were performed. The patient eventually recovered on 03-APR-2007. She received the third dose of intramuscularly on 29-SEP-2007 without an incident. Medical attention was sought, the patient saw a physician. Additional information has been requested. 04/07/2008 Information has been received from a physician concerning a 16 year old female with no pertinent medical history and no drug reactions/allergies who on 17-JAN-2007 was vaccinated with her first dose of GARDASIL. Concomitant therapy included PROTONIX. On 20-Mar-2007 the patient received her second dose of GARDASIL (lot# 653736/0014U) subcutaneously, 0.5mL once. After receiving the second dose subcutaneously the patient had an injection site reaction. The reaction consisted of pain and bruising at the injection site (also reported as 06-NOV-2007). No laboratory studies were performed. The patient eventually recovered on 03-APR-2007 (also reported as 27-NOV-2007). She received the third dose intramuscularly on 29-SEP-2007 without an incident. Medical attention was sought, the patietn saw a physician. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Disturbance in attention
Clinical narrative: Information has been received from a consumer concerning a 15 year old female with thyroid condition and no drug reactions/allergies who on 17-AUG-2007 was vaccinated with her first dose of GARDASIL and her second dose of GARDASIL on 17-OCT-2007. Concomitant therapy included propranolol HCl. The patient had been very anxious and had trouble focusing since she was given both doses of GARDSASIL. As of 04-DEC-2007, the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Skin papilloma
Clinical narrative: Information has been received from a physician concerning a female with warts on her hands who was vaccinated with Gardasil.  Subsequently the patient's warts got worse while she was taking her final exams.  There was no illness reported at the time of vaccination.  The patient's warts got worse persisted.  Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a pharmacist and described the occurrence of not responding to therapy in an adult subject of unspecified gender who was vaccinated with Engerix B for prophylaxis. On unspecified dates, the subject received the 1st, 2nd, and 3rd dose of Engerix-B (unknown). At an unspecified time after vaccination with Engerix-B, the subject did not respond to therapy.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Local reaction
Clinical narrative: Information has been received from a nurse concerning a 21 year old female with amoxicillin allergy and allergic reaction to BIAXIN who in August 2007, was vaccinated with her first dose of GARDASIL.  There was no concomitant medication.  The nurse reported that her daughter had injection site reactions after receiving her second dose of GARDASIL by subcutaneous route on 19-NOV-2007.  The patient experienced localized pain, redness and small lump at the injection site.  The patient had not yet received the third dose.  Three days after the vaccination, the patient recovered from localized pain, redness and small lump at the injection site.  Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a pharmacist and described the occurrence of not responding to therapy in an adult subject of unspecified gender who was vaccinated with Engerix-B for prophylaxis. On unspecified dates, the subject received the 1st, 2nd, and 3rd dose of Engerix-B (unknown). At an unspecified time after vaccination with Engerix-B, the subject did not respond to therapy.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning his 22 year old daughter with no medical history and/or drug reactions/allergies who on during the week of 22-NOV-2007 was vaccinated IM with the third dose of Gardasil (lot # not reported).  Dates of previous doses were not reported.  There was no concomitant medication.  "After administration of the third dose of the vaccine, the patient's arm became red and swollen.  Her arm improved after 3 days.  The patient's status was reported as recovered.  No laboratory diagnostic tests were performed.  There was no product complaint involved.  Additional information has been requested.