chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: U
Vaccine: HEPA
Symptoms: Drug ineffective, Hepatitis A antibody, Hepatitis A antibody negative
Clinical narrative: This case was reported by a physician and described the occurrence of a subject of unspecified age and gender being hepatitis A antibody negative following vaccination with HAVRIX, GlaxoSmithKline.  At the end of June 2007 the subject received 2nd dose of HAVRIX at 1440 elisa units to complete the series.  Three weeks after the 2nd dose was received the subject's physician checked for antibodies and determined that the subject was not protected by the HAVRIX vaccine.  This was considered to be a lack of effect.  At the time of reporting the outcome of the events was unspecified.  Follow-up information received on 07 August 2007 indicated that the subject was 37 years old at the time of reporting.  The outcome was not known and the event was considered by the reporter to be related to treatment with HAVRIX.  The 1st dose of HAVRIX was administered in May 2006.  No concomitant medications were taken.  A Hepatitis A IgM performed on 27 June 2007 was non-reactive.
Age: 1.7
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of vomiting in an 18-month-old male subject who was vaccinated with Havrix (GlaxoSmithKline), DTaP (Sanofi Pasteur).  The subject's medical history included celiac sprue.  On 10 July 2007 the subject received 1st dose of Havrix 0.5 (units unspecified) and the 4th dose of DTaP (dose unspecified).  On 10 July 2007, less than one day after vaccination with DTaP and Havrix, the subject experienced vomiting.  The reporting healthcare professional stated that the subject vomited for 10 days following administration of the vaccines, but no treatment was needed.  The reporter also inquired about the gluten content of Havrix.  At the time of reporting the event was unresolved.  Follow-up information was received on 07 August 2007 via a healthcare professional, who reported that the vomiting was resolved as of 23 July 2007.  The reporter listed glutens (wheat, barley, and rice) as co-suspect products for the vomiting.  The healthcare professional considered the event was possibly related to vaccination with Havrix and DTaP, but also indicated the patient's medical history/concurrent illness of celiac disease as a possible cause of the event.  At the time of reporting, the event was resolved.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Menstruation irregular
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of irregular menstrual cycle in a 18-year-old female subject who was vaccinated with Havrix (GlaxoSmithKline). Concurrent vaccination included Gardasil (Merck; unknown given on 12 June 2007). On 12 June 2007 the subject received 1st dose of Havrix (unknown). In June 2007, at an unspecified time after vaccination with Havrix, the subject experienced irregular menstrual cycle. At the time of reporting the event was improved. The healthcare professional considered the event was possibly related to vaccination with Havrix.
Sex: U
Vaccine: HEPA
Symptoms: Injection site pain
Clinical narrative: This case was reported by a physician and described the occurrence of injection site stinging in subject of unspecified age and gender who was vaccinated Havrix (GlaxoSmithKline). Concurrent vaccination given on the same day as Havrix included varicella virus vaccine. On an unspecified date the subject received unspecified dose of Havrix (unknown). Less than one day after vaccination with Havrix, the subject experienced injection site stinging. At the time of reporting the outcome of the event was unspecified. The reporter stated that this events had occurred in an unknown number of patients of all ages and with multiple lots of Havrix. It was questioned if the Havrix involved was the preservative-free formulation.
Age: 12.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Blood glucose normal, Blood pressure normal, Dizziness, Hyperhidrosis, Hyperventilation
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of dizziness in a 12-year-old male subject who was vaccinated with HAVRIX, GlaxoSmithKline.  Concurrent vaccination included VARIVAX (Merck) given on 6 August 2007.  Concurrent medications included Fexofenadine hydrochloride (Allegra).  On 6 August 2007 the subject received 1st dose of HAVRIX at 0.5 ml in the right arm.  A short time after vaccination with HAVRIX, as the subject was on his way to the car, he experienced dizziness, sweating, pallor, almost fainting and legs buckling.  He returned inside the office and was watched and allowed to recline for two hours.  He never lost consciousness.  His blood pressure and glucose were normal.  He also reported tingling hands most likely from hyperventilating.  He was released after two hours.  All events were resolved, with the outcomes of tingling hands and hyperventilation not specified.  The events of dizziness, sweating and pallor were reported as possibly related to treatment with HAVRIX.  Almost fainting and legs buckling was unrelated.  Relationship of tingling hands and hyperventilation was not reported.  Follow-up received on 20 September 2007 from the healthcare professional indicated that the events resolved.
Age: 12.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Muscular weakness, Pallor, Paraesthesia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of dizziness in a 12-year-old male subject who was vaccinated with HAVRIX, GlaxoSmithKline.  Concurrent vaccination included VARIVAX (Merck) given on 6 August 2007.  Concurrent medications included Fexofenadine hydrochloride (Allegra).  On 6 August 2007 the subject received 1st dose of HAVRIX at 0.5 ml in the right arm.  A short time after vaccination with HAVRIX, as the subject was on his way to the car, he experienced dizziness, sweating, pallor, almost fainting and legs buckling.  He returned inside the office and was watched and allowed to recline for two hours.  He never lost consciousness.  His blood pressure and glucose were normal.  He also reported tingling hands most likely from hyperventilating.  He was released after two hours.  All events were resolved, with the outcomes of tingling hands and hyperventilation not specified.  The events of dizziness, sweating and pallor were reported as possibly related to treatment with HAVRIX.  Almost fainting and legs buckling was unrelated.  Relationship of tingling hands and hyperventilation was not reported.  Follow-up received on 20 September 2007 from the healthcare professional indicated that the events resolved.
Sex: U
Vaccine: HEPA
Symptoms: Injection site pain, Screaming
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of stinging during injection in an unspecified number of subjects of unspecified ages and genders who were vaccinated with Havrix (GlaxoSmithKline).  On an unspecified date the subjects received unspecified dose of Havrix (unknown).  The reporter stated that approximately one-third of patients were "screaming and saying that the Havrix injection stings."  The nurse believed that the event "may be due to the reformulation".  At the time of reporting the outcome of the event was was unspecified.
Sex: U
Vaccine: HEPA
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a sales representative via a healthcare professional and described the occurrence of sore arm in an adult subject of unspecified gender who was vaccinated with HAVRIX (GlaxoSmithKline) for prophylaxis. On or after 24 July 2007, the subject received unspecified dose of HAVRIX (1440 units, unknown). Immediately after vaccination with HAVRIX, the subject experienced sore arm. At the time of reporting the outcome of the event was unspecified. She was concerned that this event may be due to a particular lot number or due to the reformulation of the vaccine. The reporter considered that the event were probably related to the use of HAVRIX. Follow-up information received on 17 September 2007 indicated that the subjects experienced arm soreness immediately after the injection. Subjects noted that, "I can feel that all the way down my arm." It was noted that the pain and soreness at the injection site did not last very long. It was reported that when the subjects left the office they were no longer complaining of soreness at the site or with their arm. It was reported that this event occurred with both the 1st dose of HAVRIX administered to the subject as well as the booster dose. Vaccine was given intramuscularly in an unknown deltoid. Outcome of the events resolved. In the reporter's opinion, the events were related to treatment with HAVRIX. A statement was provided that this event occurred in multiple subjects over a 6 week period. The reporter also noted that she would be interested to see if these complaints decreased when the lot number changed.
Sex: U
Vaccine: HEPA
Symptoms: Immediate post-injection reaction, Pain
Clinical narrative: This case was reported by a sales representative via a healthcare professional and described the occurrence of shooting pains in an adult subject of unspecified gender who was vaccinated with Havrix (GlaxoSmithKline).  On or after 24 July 2007, the subject received unspecified dose of Havrix (1 ml, unknown).  Immediately after vaccination with Havrix, the subject experienced shooting pains in the arm.  At the time of reporting the outcome of the event was unspecified.  She was concerned that this event may be due to a particular lot number or due to the reformulation of the vaccine.  The reporter considered that the events were probably related to the use of Havrix.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site erythema, Skin exfoliation, Thermal burn
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of peeling of skin around injection site in a 2-year-old female subject who was vaccinated with Havrix (GlaxoSmithKline). On 28 August 2007, the subject received an unspecified dose of Havrix (unknown, left arm). Within 3 to 5 days vaccination with Havrix, the subject experienced peeling of skin around injection site, and injection site redness that had a burn-like appearance. the subject was seen in the physician's office (treatment unspecified). At the time of reporting the events were unresolved.
Sex: F
Vaccine: HEPA
Symptoms: Headache, Influenza like illness, Injection site reaction, Nausea
Clinical narrative: This case was reported by a healthcare professional to a sales representative and described the occurrence of flu like symptoms in an adult female subject who was vaccinated with Havrix (GlaxoSmithKline).  On 24 September 2007 the subject received 1st dose of Havrix (1440 elisa unit, unknown, unknown arm).  The subject did not receive any other vaccines on 24 September 2007.  On the morning of 25 September 2007, 1 day after vaccination with Havrix, the subject experienced flu like symptoms, nausea, headache and injection site reaction.  The subject was seen at a physician's office.  At the time of reporting the events were worse.  The vaccination course with Havrix was discontinued.  The healthcare professional considered the events were probably related to vaccination with Havrix.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: No reaction on previous exposure to drug, Urticaria
Clinical narrative: This case was reported by a physician and described the occurrence of urticaria in a 3-year-old female subject who was vaccinated with Engerix B (GlaxoSmithKline).  In September 2007 the subject received 2nd dose of Engerix B at 720 elisa units.  Approximately 8 to 20 hours after vaccination with Engerix B, the subject developed urticaria over her body.  She was treated with Benadryl and the urticaria resolved.  Two to three days later, she developed hives, which again resolved with additional Benadryl.  Follow-up received on 15 October 2007 from a physician indicated that the subject received Havrix instead of Engerix-B.  The subject had previously received the first dose of Havrix in August 2006 and had no problems after receiving the first dose.  Further information was not provided.  Follow-up was received by a physician who is an allergist, via Merck Research Laboratories.  Medical conditions were notable for no drug reactions or allergies and no pertinent medical history.  The subject did not have any problems with the 1st dose of hepatitis A vaccine.  The subject received no concurrent medication.  The subject received the 2nd dose of Havrix (GlaxoSmithKline) and developed urticaria all over her body the following morning.  The physician estimated that the onset of the urticaria was 8 to 15 hours after receiving the 2nd dose of Havrix.  The subject's parents called the subject's primary care physician who instructed that the subject take Benadryl.  The hives appeared to a lesser extent each day and resolved without sequelae.
Sex: U
Vaccine: HEPA
Symptoms: Erythema, Swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of localized erythema in an unspecified number of subjects of unspecified ages and genders who were vaccinated with a Havrix (GlaxoSmithKline). The reporter indicated that some of the subjects may have received concurrent Menactra (Sanofi Pasteur) "because that was common". The reporter also indicated that there were probably other concurrent vaccines "but did not know exactly which" vaccines might have been concurrently administered. On unspecified dates the subjects received unspecified doses of Havrix (.5 mL/ 720 elisa units, unknown). At an unspecified time after vaccination with Havrix, the subjects experienced localized redness and/or localized swelling. The reporter questioned whether "there had been any recall on any lots of Havrix" due to an increase in reports of redness and swelling in subjects who had been vaccinated with Havrix. At the time of reporting the outcomes of the events were unspecified.
Sex: F
Vaccine: HEPA
Symptoms: Injection site rash, Oedema peripheral
Clinical narrative: This case was reported by a consumer, via Merck Research Laboratories, and described the occurrence of swelling arm in a female subject of unspecified age who was vaccinated with Havrix (GlaxoSmithKline).  The consumer is the mother of the subject.  A physician or other health care professional has not verified this report.  On an unspecified date the subject received unspecified dose of Havrix (unknown).  On 25 August 2007, at an unspecified time after vaccination with Havrix, the subject experienced swelling in her right arm.  On 23 September 2007, the subject developed an injection site rash.  At the time of reporting the outcome of the events were was unspecified.  Follow-up was received from the initial reporting consumer, via Merck Research Laboratories.  The consumer contacted Merck and asked, "Is there a blood test that will show if my daughter has HPV vaccine in her blood?"  It was not reported if the HPV vaccine was administered to the subject.  No additional information was provided.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Erythema multiforme, Rash
Clinical narrative: This case was reported by a healthcare professional to a sales representative and described the occurrence of erythema multiforme in an 18-month-old female subject who was vaccinated with Havrix (GlaxoSmithKline). The subject's medical condition was considered "healthy." The healthcare professional did not report if the subject received any other vaccinations or concurrent medications on the date of the Havrix administration. On 22 October 2007 the subject received 1st dose of "pediatric" Havrix (unknown). On 27 October 2007, 5 days after vaccination with Havrix, the subject experienced rash or erythema multiforme. The subject was seen by a physician on 29 October 2007. The subject had also visited a pumkin farm following the vaccination. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were worse.
Sex: U
Vaccine: HEPA
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of swelling injection site in a subject of unspecified age and gender who was vaccinated with HAVRIX 720, GlaxoSmithKline.  Concurrent vaccinations received the same day were unspecified, but may have included live attenuated measles, mumps (strain not specified), rubella vaccine (MMR).  In 2007 on an unspecified date within the last two weeks of this report, the subject received unspecified dose of HAVRIX 720 (unknown).  Immediately after vaccination with HAVRIX 720, the subject experienced swelling injection site.  At the time of reporting the outcome of the event was unspecified.  The physician considered the event was probably related to vaccination with HAVRIX 720.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a college health registered nurse concerning a female who was vaccinated with either a second or third dose of Gardasil (lot #659962/1740U).  Subsequently the patient developed pain at the injection site.  It was reported that it was the worst shot she ever had.  The patient sought medical attention in the office.  At the time of the report, the patient's outcome was unknown.  The register nurse is requesting a lot check.  Additional information has been requested. 07/08/2008 This is in follow-up to report(s) previously submitted on 3/14/2008; 7/8/2008; 1/7/2009. Initial and follow-up information has been received from a registered nurse concerning an approximately 20 year old female who was vaccinated IM with either a second or third dose of GARDASIL (lot #659962/1740U). Subsequently the patient developed excrutiating pain at the injection site. It was reported that it was the worst shot she ever had. At the time of the report, the patient's outcome was unknown. The registered nurse is requesting a lot check. A standard lot check investigation was performed. All in-process quality checks for the lot number 659962/1740U was satisfactory. The lot # 659962/1740U met the requirements of the Center for Biologics Evaluation and Research and was released. A standard lot check was performed. All in-process quality checks for the lot number 659962/1740U in question were satisfactory. In addition an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot number 6599/1740U met the requirements of the Center for Drug Evaluation and Research and was released. This is one of several reports received from the same source. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pruritus
Clinical narrative: Information has been received from a health professional concerning a 15 year old female with a history of drug hypersensitivity to amoxicillin who on 27-AUG-2007 was vaccinated with her first dose of GARDASIL (lot 658222/0927U). Concomitant therapy included ORTHO TRI-CYCLEN, vitamins (unspecified) and RETIN-A. On 29-Oct-2007 the patient was vaccinated with her second dose of GARDASIL (lot 658558/1061U). On 27-AUG-2007 and 29-Oct-2007 the patient experienced pruritus at the injection site. The patient sought unspecified medical treatment. Subsequently, the patient recovered from pruritus at injection site after longer than a week. Additional information has been requested. No further information is expected.
Sex: U
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of hives on chest in a subject of unspecified age and gender who was vaccinated with HAVRIX 720, GlaxoSmithKline.  Concurrent vaccinations received the same day were unspecified, but may have included live attenuated measles, mumps (strain not specified), rubella vaccine (MMR).  In 2007 on an unspecified date within the last two weeks of this report, the subject received unspecified dose of HAVRIX 720 (unknown).  At an unknown time after vaccination with HAVRIX 720, the subject experienced hives on chest.  At the time of reporting the outcome of the event was unspecified.  The physician considered the event was possibly related to vaccination with HAVRIX 720.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyspnoea, Feeling hot, Hyperhidrosis
Clinical narrative: Information has been received from a healthcare professional concerning a female who on an unspecified date was vaccinated with her second dose of GARDASIL (lot number unspecified). On 29-FEB-2008 the patient was vaccinated with her third dose of GARDASIL (lot number unspecified). Subsequently after the second dose the patient felt warm and sweaty, felt faint and felt like she needed air. The nurse reported that the patient did not wait 10 minutes after receiving the dose because she had to leave. The nurse reported that the office did not hear about this event until patient came into the office on 29-Feb-2008 for her third dose. The nurse reported the patient sought unspecified medical treatment. No adverse experience was reported after receiving her third dose. Subsequently, the patient recovered. Additional information has been requested.
Sex: U
Vaccine: HEPA, UNK
Symptoms: Urticaria
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of hives on chest in a subject of unspecified age and gender who was vaccinated with Havrix 720 (GlaxoSmithKline).  Concurrent vaccinations received the same day were unspecified, but may have included MMR.  In 2007 on an unspecified date within the last two weeks of this report, the subject received unspecified dose of Havrix 720 (unknown).  At an unknown time after vaccination with Havrix 720, the subject experienced hives on chest.  At the time of reporting the outcome of the event was unspecified.  The physician considered the event was possibly related to vaccination with Havrix 720.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Skin papilloma
Clinical narrative: Information has been received from a 28 year old female health care professional and consumer with a history of wart on her hands (2001/2002) who on 15-AUG-2006 was vaccinated with the first dose of Gardasil (lot # not reported). In October 2006 the patient was vaccinated with the second dose of Gardasil (lot # not reported). In January 2007 the patient was vaccinated with the third dose of Gardasil (lot # not reported). Concomitant therapy included vitamins (unspecified). In February 2007 "one month" after completion of the series the patient began experiencing warts on her hands. She had a history of warts on her hands but her last "outbreak" was 5 years prior to receiving Gardasil around 2001/2002. It was reported that she has been developing these warts on different spots on her hands from February 2007 to the present day. She also reported that she has to have these warts frozen and removed periodically. The warts were never tested (no biopsy) or etiology unknown. The patient has not recovered. Additional information has been requested. follow up 2/16/2010- follow up information received on 15-apr-2006. the patient, a white female weighing 235 pounds and height of 69 inches. on approximately march 2007 broke out with warts on her right and left hands about two months after her injection. patient has had "cryo" therapy on them several times. they re-occur in different spots each time. at the time of the report it was unknown if the patient had recovered. the lot number of all three vaccine given to the patient was 651650/0702f.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a Nurse concerning a female who on an unspecified date, was vaccinated with a dose of Gardasil (route, site and lot# not provided).  It was reported that the patient fainted after administration of vaccine.  It was unknown whether medical attention was sought.  The patient's outcome is unknown.  No product quality complaint was involved.  Additional information has been requested.  This is in follow-up to report(s) previously submitted on 3/14/2008.  Information has been received from a Nurse concerning a female who on an unspecified date, was vaccinated with a dose of GARDASIL (route, site and lot# not provided).  It was reported that the patient fainted after administration of vaccine.  It was unknown whether medical attention was sought.  The patient's outcome is unknown.  No product quality complaint was involved.  Additional information is not expected.
Age: 12.0
Sex: M
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of rash in a 12-year-old male subject who was vaccinated with HAVRIX, GlaxoSmithKline.  It was assumed that HAVRIX was administered, the reporter was unclear whether the patient received HAVRIX or Hepatitis A vaccine (Merck).  On 9 November 2007 at 11:00, the subject received 1st dose of HAVRIX (.5 ml, unknown).  At an unspecified time after vaccination with HAVRIX, the subject experienced a rash.  The healthcare professional was notified on 14 November 2007 that the patient developed a rash.  It was reported that the patient was going to be seen in the clinic for follow-up.  The immunization series was delayed.  At the time of reporting, the outcome of the event was unspecified.  The healthcare professional considered the event was possibly related to vaccination with HAVRIX.
Sex: U
Vaccine: HEPA
Symptoms: Burning sensation, Crying
Clinical narrative: This case was reported by a physician, via a sales representative, and described the occurrence of burning (nos) in a child subject of unspecified gender who was vaccinated with HAVRIX, GlaxoSmithKline.  It was unknown if other vaccines were given on the same day as HAVRIX.  On an unspecified date the subject received unspecified dose of HAVRIX (.5 ml, unknown).  At an unspecified time after vaccination with HAVRIX, the subject experienced burning (nos) and crying.  It was noted that this practice did not have the same issues with VAQTA and they also commented that they did not like the prefilled syringes.  At the time of reporting the outcome of the events were unspecified.  It was noted that these events occurred in "pediatric patients."
Sex: M
Vaccine: HEPA
Symptoms: Nonspecific reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of nonspecific reaction in a male subject of unspecified age who was vaccinated with Havrix (GlaxoSmithKline). On an unspecified date the subject received 1st dose of Havrix (1 ml, unknown). At an unspecified time after vaccination with Havrix, the subject experienced nonspecific reaction. It was reported the immunization series was discontinued and/or delayed. No other information was provided. At the time of reporting the outcome of the event was unspecified.
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain upper, Fatigue, Headache, Inappropriate schedule of drug administration, Menorrhagia
Clinical narrative: This case was reported by a consumer and described the occurrence of excessive menstrual bleeding in a 13-year-old female subject who was vaccinated with Havrix (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  Concurrent medical conditions included asthma and Augmentin allergy.  Concurrent medications included Zoloft.  On 23 August 2007 in the morning and 18 October 2007 the subject received 1st dose and 2nd dose of Havrix (unknown).  At an unspecified time after vaccination with Havrix, the subject experienced excessive menstrual bleeding, headache, tiredness, sore throat, stomach pain and inappropriate schedule of vaccine administered.  Medical attention was required in the emergency room and the subject consulted a healthcare professional.  The headache, tiredness, sore throat and stomach pain were unresolved.  The outcome of the excessive menstrual bleeding was unspecified.
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Pharyngolaryngeal pain
Clinical narrative: This case was reported by a consumer and described the occurrence of excessive menstrual bleeding in a 13-year-old female subject who was vaccinated with Havrix (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  Concurrent medical conditions included asthma and Augmentin allergy.  Concurrent medications included Zoloft.  On 23 August 2007 in the morning and 18 October 2007 the subject received 1st dose and 2nd dose of Havrix (unknown).  At an unspecified time after vaccination with Havrix, the subject experienced excessive menstrual bleeding, headache, tiredness, sore throat, stomach pain and inappropriate schedule of vaccine administered.  Medical attention was required in the emergency room and the subject consulted a healthcare professional.  The headache, tiredness, sore throat and stomach pain were unresolved.  The outcome of the excessive menstrual bleeding was unspecified.
Age: 10.0
Sex: M
Vaccine: HEPA
Symptoms: Diarrhoea, Headache, Inappropriate schedule of drug administration, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of diarrhea in a 9-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline) for prophylaxis. A physician or other health care professional has not verified this report. The subject's medical history included seasonal allergy. Concurrent medical conditions included asthma. Concurrent medications included ADVAIR. On 23 August 2007 in the morning and 18 October 2007 the subject received 1st dose and 2nd dose of HAVRIX (unknown). At an unspecified time after vaccination with HAVRIX, the subject experienced diarrhea, fever, headache, sore throat and inappropriate schedule of vaccine administered. Medical attention was required in the emergency room and a healthcare professional was consulted. At the time of reporting, the diarrhea, fever, headaches and sore throat were unresolved.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Allergy test, Arthralgia, Musculoskeletal pain, Pain in extremity
Clinical narrative: Information has been received from a health professional concerning a 17 year old female who in March 2007, was vaccinated with a dose of Gardasil. In September 2007, the patient received the third dose. One month later in the patient experienced sudden onset of pain in the injection site arm, elbow and shoulder. At the time of reporting the pain had persisted and it had worsened. The patient saw the nurse practitioner and was referred to orthopedist. The patient's outcome is unknown. Additional information has been requested.  1/5/10 follow up - injection site pain,muscular weakness
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Rash generalised
Clinical narrative: Information has been received from a nurse practitioner, concerning an 18 year old female who on 05-FEB-2008, was vaccinated with her first dose of GARDASIL 0.5 ml (lot# 659437/1266U). The patient received the vaccination and experienced a rash all over her body particularly her upper chest, arm and face. Unspecified medical attention was sought. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of fever in a 2-year-old male subject who was vaccinated with HAVRIX, GlaxoSmithKline.  On the afternoon of 12 December 2007 the subject received the second dose of HAVRIX (0.5 mL, unknown, left arm).  On 13 December 2007, 1 day after vaccination with HAVRIX, the subject experienced a fever ranging from 102 to 105 degrees Fahrenheit.  He required medical attention at the doctor's office.  The healthcare professional considered the event was disabling.  At the time of reporting the event was unresolved.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse, concerning a female colleague who on the evening of 27-FEB-2008 was vaccinated with her third dose of GARDASIL (lot# unspecified) in the left deltoid. The nurse reports that her colleague had a prickly looking rash on both forearms the next day. The nurse confirms that her colleague was vaccinated at her primary care givers office, and only came to her for advice. Nurse states that she is not able to provide any other information. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain
Clinical narrative: Information has been received from a health professional concerning her 21 year old daughter who was recently vaccinated with the first two doses of GARDASIL (dates and lot numbers not reported). After each dose the patient developed abdominal cramping, similar to menstrual cramps. Subsequently, the patient recovered from abdominal cramping after each dose (dates not specified by reporter). The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Depression
Clinical narrative: Information has been received from a physician concerning a patient's daughter who on unspecified date was vaccinated with GARDDASIL (lot # unspecified). The day after receiving GARDASIL the patient experienced depression. Unspecified medical attention was sought. At the time of this report, the patient has not recovered from the depression. No further information was available. No additional information is expected or available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Colposcopy, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 19 year old single female who on 19-JUN-2007 was vaccinated with the first dose of GARDASIL (Lot # "0389U"), on 23-Aug-2007 was vaccinated with the second dose of GARDASIL (Lot # 658488/0930U) and on 03-Jan-2008 was vaccinated with the third dose of GARDASIL (Lot # 658558/1061U). The patient had an abnormal PAP test since receiving the vaccinations. The patient needed a colposcopy. The patient did not have a positive PAP test prior to receiving the vaccinations. Medical attention was sought in the office. Patient outcome was unknown. No product quality complaint was involved. Additional information has been requested.  This is in follow-up to report(s) previously submitted on 3/14/2008.  No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Colposcopy, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 21 year old single female who was vaccinated on 21-Jan-2008 with the first dose of GARDASIL (Lot # 65855/1061U). The patient had an abnormal PAP test since receiving the vaccination and needed a colposcopy. The patient did not have positive PAP test prior to receiving the vaccination. Unknown medical attention was sought in the office. Patient outcome was unknown. No product quality was involved. Additional information has been requested.  Follow-up information was received indicating that the patient received GARDASIL the same day as abnormal PAP. Follow-up information was received from a physician indicating that she does not have any additional information at this time and in re-reviewing the chart, the doctor wishes to withdrawal the report. This report is related to reports WAES # 0802USA04152, 0803USA01372, 0803USA01381 with the same source. No further information is available.
Age: 13.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Injection site pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site soreness in a 13-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline) for prophylaxis. Previous and/or concurrent vaccination included influenza virus vaccine (Novartis) given on 27 December 2007. Concurrent medications included ZOLOFT. On 27 December 2007 at 11:00 the subject received 1st dose of HAVRIX (1 ml, left arm). On 27 December 2007, immediately after vaccination with HAVRIX, the subject experienced injection site soreness. The subject also experienced inappropriate dose of vaccine administration as he received the adult dose. The nurse noted that she thought the soreness at the injection site was from the alcohol not drying completely. At the time of reporting the soreness at the injection site was unresolved.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Colposcopy, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning an 18 year old single female who was vaccinated on 23-Jan-2007 with the first dose of GARDASIL (Lot # 655165/1425F), on 23-Mar-2007 was vaccinated with the second dose of GARDASIL (Lot # 655165/1425F) and on 23-Jul-2007 was vaccinated with the first dose of GARDASIL (Lot # "0389U"). The patient has an abnormal PAP test since receiving the vaccination and needed a colposcopy. The patient did not have positive PAP test prior to receiving the vaccination. Medical attention was sought in the office. Patient outcome was unknown. No product quality complaint was involved. Additional information has been requested. 02/17/2010 Follow up information was received from a physician indicating that the patient had the first abnormal PAP in July 2007 (ASCUS with diagnosis of HPV) and in January 2008 underwent colposcopy which was bening. The patient is still being treated. Follow up information was received from a physician indicating that she does not have any additional information at this time and in re-reviewing the chart, the doctor wishes to withdral the report. This report is realted to report WAES # 0902USA04152, 0803USA01379, 0803USA01380 with the same source. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Injection site pain
Clinical narrative: Information has been received from a college health registered nurse concerning a female who was vaccinated with either a second or third dose of GARDASIL (lot #659962/1740U). Subsequently the patient developed pain at the injection site. It was reported that it was the worst shot she ever had. The patient had to lie down because "the shot hurt so bad." The patient was weak and "felt like fainting." The patient sought medical attention in the office. At the time of the report, the patient's outcome was unknown. The registered nurse is requesting a lot check.  This is in follow-up to report(s) previously submitted on 3/14/2008; 7/8/2008; 1/7/2009. Initial and follow-up information has been received from a college health registered nurse concerning an approximately 20 year old female who was vaccinated with either a second or third dose of GARADASIL (lot #659962/1740U). Subsequently the patient developed excruciating pain at the injection site. It was reported that it was the worst shot she ever had. The patient had to lie down because "the shot hurt so bad". The patient was weak and "felt like fainting". The patient sought medical attention in the office. At the time of the report, the patient's outcome was unknown. The registered nurse is requesting a lot check. A standard lot check investigation was performed. All in-process quality checks for the lot number 659962/1740U was satisfactory. The lot # 659962/1740U met the requirements of the Center for Biologics Evaluation and Research and was released. A standard lot check was performed. All in-process quality checks for the lot number 659962/1740U in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot number 659962/1740U met the requirements of the Center for Drug Evaluation and Research and was released. This is one of several reports received from the same sourced. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Injection site pain
Clinical narrative: Information has been received from a college health registered nurse concerning a female who was vaccinated with either a second or third dose of GARDASIL (lot # 6559962/1740U). Subsequently the patient developed pain at the injection site. It was reported that it was the worst shot she ever had. The patient had to lie down because "the shot hurt so bad." The patient was weak and "felt like fainting." The patient sought medical attention in the office. At the time of the report, the patient's outcome was unknown. The registered nurse is requesting a lot check. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Red swollen arm
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Injected limb mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: Initial report received on 12 December 2007 from a health care professional in the United States. A 19 year-old male patient received on 30 October 2007 Menactra (lot#U2427AA) and at the evening of the same day, began having pain in his entire left arm. He had pain when he moved his arm a certain way and he could not lift a weight over his head. The muscle felt tired. There was no redness or swelling. Treated with Medrol dose pack with no change (in his condition). The patient was seen again by a physician as the pain was becoming worse. Naproxen was prescribed but there was no change (in his condition). The patient was planning to see an orthopedic PhD and to get an MRI. No relevant laboratory or diagnostic tests were done. The patient had no illness at vaccination time. No other vaccines were given around the same time. The patient's medical history included: NKA (No Known Allergies), asthma, anxiety and depression. The patient's concomitant medications included: albuterol inhaler, Clonipine and Zoloft. No adverse event was reported following prior vaccination. The patient had not recovered. Upon internal review: the initial report received on 11 December 2007 (and not as reported previously) from a health care professional.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abnormal behaviour, Full blood count, Laboratory test normal, Lymphocyte count decreased, Pallor
Clinical narrative: Previously healthy, received 1st set of immunizations.  That evening during bath, turned pale white, not acting right for few hours, went to ER and admitted to hospital.    5/16/08 Reviewed hospital medical records of 2/28-2/29/208. FINAL DX: apparent life threatening event Records reveal patient experienced pallor & 'not acting right' for a few hours after vaccinations.  Temp 100.4 in ER.  Admitted to be monitored overnight.  No further episodes & d/c to home.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: White blood cell count increased
Clinical narrative: Previously healthy, received 1st set of immunizations.  That evening during bath, turned pale white, not acting right for few hours, went to ER and admitted to hospital.    5/16/08 Reviewed hospital medical records of 2/28-2/29/208. FINAL DX: apparent life threatening event Records reveal patient experienced pallor & 'not acting right' for a few hours after vaccinations.  Temp 100.4 in ER.  Admitted to be monitored overnight.  No further episodes & d/c to home.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging normal, Optic neuritis, Visual evoked potentials normal, Visual field defect
Clinical narrative: Optic neuritis 6 wks after vaccine.  Rx high dose solumedrol followed by prednisone. 3/31/08-treatment records received from facility for DX optic neuritis. IV steroid therapy. 5/6/08-records received for DOS 2/15/08-presented with left eye visual symptoms, began somewhat abruptly 10 days prior with visual blurring and left periorbital pain. Moving his eyes caused some discomfort. Optic nerve head pallor and some peripapillary hemorrhages. Treated with Solu-Medrol.
Age: 8.0
Sex: F
Vaccine: FLUN3, HEPA
Symptoms: Bronchitis, Chest X-ray abnormal, Convulsion, Cough, Electroencephalogram normal
Clinical narrative: 3 days after vaccine in the morning developed a seizure, nasal stuffiness and sore throat. One week later had a cough, then fever. 2 weeks later placed on Augmentin ES for sinusitis and Zithromax for bronchitis. Began wheezing 3 weeks after vaccine. started asthma meds. Diagnosed pneumonia. Added Prednisone. Went on airplane, became hypoxic, needed emergency oxygen. Taken to Emergency room. Fully recovered.  4/1/08 Reviewed ER medical records of 12/29/2007. FINAL DX: Pneumonia. Records reveal patient experienced SOB, & feeling ill since vax date w/multiple respiratory illness.  Dx w/pneumonia on 12/24/07.  Completed the antibiotics as prescribed for that.  Currently on antibiotics for sinusitis, nebs & steroids for respiratory problems w/o improvement.  Exam revealed decreased air movement & slight wheezing.
Age: 8.0
Sex: F
Vaccine: FLUN3, HEPA
Symptoms: Full blood count, Hypoxia, Nasal congestion, Nuclear magnetic resonance imaging brain normal, Oxygen supplementation
Clinical narrative: 3 days after vaccine in the morning developed a seizure, nasal stuffiness and sore throat. One week later had a cough, then fever. 2 weeks later placed on Augmentin ES for sinusitis and Zithromax for bronchitis. Began wheezing 3 weeks after vaccine. started asthma meds. Diagnosed pneumonia. Added Prednisone. Went on airplane, became hypoxic, needed emergency oxygen. Taken to Emergency room. Fully recovered.  4/1/08 Reviewed ER medical records of 12/29/2007. FINAL DX: Pneumonia. Records reveal patient experienced SOB, & feeling ill since vax date w/multiple respiratory illness.  Dx w/pneumonia on 12/24/07.  Completed the antibiotics as prescribed for that.  Currently on antibiotics for sinusitis, nebs & steroids for respiratory problems w/o improvement.  Exam revealed decreased air movement & slight wheezing.
Age: 8.0
Sex: F
Vaccine: FLUN3, HEPA
Symptoms: Pharyngolaryngeal pain, Pneumonia, Pyrexia, Sinusitis, Wheezing
Clinical narrative: 3 days after vaccine in the morning developed a seizure, nasal stuffiness and sore throat. One week later had a cough, then fever. 2 weeks later placed on Augmentin ES for sinusitis and Zithromax for bronchitis. Began wheezing 3 weeks after vaccine. started asthma meds. Diagnosed pneumonia. Added Prednisone. Went on airplane, became hypoxic, needed emergency oxygen. Taken to Emergency room. Fully recovered.  4/1/08 Reviewed ER medical records of 12/29/2007. FINAL DX: Pneumonia. Records reveal patient experienced SOB, & feeling ill since vax date w/multiple respiratory illness.  Dx w/pneumonia on 12/24/07.  Completed the antibiotics as prescribed for that.  Currently on antibiotics for sinusitis, nebs & steroids for respiratory problems w/o improvement.  Exam revealed decreased air movement & slight wheezing.