chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: This case was reported by a healthcare professional, via an agency sales representative, and described the occurrence of injection site soreness in an unspecified number of adult subjects of unspecified genders who were vaccinated with HAVRIX (GlaxoSmithKline).  In May 2008, the subject (s) received unspecified dose(s) of HAVRIX 1440 (unknown).  A nurse reported, via an agency sales representative, that an unspecified number of adults (genders unspecified) experienced severe soreness at the injection site immediately following vaccinations(s) with HAVRIX 1440.  It was unclear how long the pain continued post injection(s), as the sales representative had limited information to provide.  At the time of reporting, the outcome of the event was unspecified.  The healthcare professional considered the event was probably related to vaccination with HAVRIX 1440.  Follow up information received on 27 June 2008 indicated that the reporter has received numerous reports of pain and stinging at the injection site when administering HAVRIX (AHAVB224AA) to both adults and children.  No HAVRIX dose was provided for vaccine given to children.  No redness or indurations appeared, but frequent complaints of intense pain during and shortly thereafter giving the injection;  more than nurse noted the problem.  The site started administering a different lot of HAVRIX (AHAVB251AA) and continues to receive complaints.
Sex: F
Vaccine: HEPA
Symptoms: Nonspecific reaction
Clinical narrative: This case was reported by a consumer and described the occurrence of a nonspecific reaction in a female subject of unspecified age who was vaccinated with HAVRIX. A physician or other health care professional has not verified this report. On 1 May 2006 the subject received unspecified dose of HAVRIX (unknown). At an unspecified time after vaccination with HAVRIX, the subject experienced a terrible nonspecific reaction. At the time of reporting the outcome of the event was unspecified.
Sex: U
Vaccine: HEPA
Symptoms: Arthralgia, Musculoskeletal pain, Neck pain, Pain, Pain in extremity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm pain in a subject of unspecified age and gender who was vaccinated with HAVRIX (manufacturer unspecified). On an unspecified date the subject received unspecified dose of HAVRIX. At the time of injection with HAVRIX, the subject experienced arm pain and shoulder pain. The reporter stated that it seems to have started occurring in the last 6 months. Subjects complain of a sudden, brief, but significant pain that shoots down the arm to the elbow or sometimes up into the shoulder and neck. This was considered to be a product complaint. The reporter has been giving the vaccine since 1995 and it never happened before. At the time of reporting the outcome of the events was unspecified. These events occurred in a number of different subjects from the same source, but with different contacts. Linked cases include A0732483A, A0732491A, A0732492A, A0732500A, A0732501A, A0732515A, A0732528A, A0732533A, A0732539A, A0732540A, A0732936A and A073244A.
Sex: U
Vaccine: HEPA
Symptoms: Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm pain in a subject of unspecified age and gender who was vaccinated with HAVRIX (manufacturer unspecified). On an unspecified date the subject received unspecified dose of HAVRIX. At the time of injection with HAVRIX, the subject experienced arm pain and shoulder pain. The reporter stated that it seems to have started occurring in the last 6 months. Subjects complain of a sudden, brief, but significant pain that shoots down the arm to the elbow or sometimes up into the shoulder and neck. This was considered to be a product complaint. The reporter has been giving the vaccine since 1995 and it never happened before. At the time of reporting the outcome of the events was unspecified. These events occurred in a number of different subjects from the same source, but with different contacts. Linked cases include A0732483A, A0732491A, A0732492A, A0732500A, A0732501A, A0732515A, A0732528A, A0732533A, A0732539A, A0732540A, A0732936A and A073244A.
Sex: F
Vaccine: HEPA
Symptoms: Injection site irritation, Paraesthesia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of burning in a female subject of unspecified age who was vaccinated with HEPATITIS A. On an unspecified date the subject received unspecified dose of HEPATITIS A vaccine. At an unspecified amount of time following injection with HEPATITIS A vaccine, the subject experienced burning and tingling. The burning and tingling worked it's way down the arm. The reporter stated that the events only last 2 to 5 minutes and then seem to be fine. Resolution was not specifically stated. The reporter felt that this was not occurring say 6 months ago. These events occurred in a number of different subjects from the same source, but with different contacts. Linked cases included A0732483A, A0732491A, A0732492A, A0732501A, A0732515A, A0732528A, A0732533A, A0732539A, A0732540A, A0732936A and A0732944A.
Sex: M
Vaccine: HEPA
Symptoms: Burning sensation, Paraesthesia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of burning in a male subject of unspecified age who was vaccinated with HEPATITIS A vaccine, (manufacturer unspecified).  On an unspecified date the subject received unspecified dose of HEPATITIS A vaccine.  At an unspecified amount of time following injection with HEPATITIS A vaccine, the subject experienced burning and tingling.  The burning and tingling worked it's way down the arm.  The reporter stated that the events only last 2 to 5 minutes and then seem to be fine.  Resolution was not specifically stated.  The reported felt that this was not occurring say 6 months ago.  These events occurred in a number of different subjects from the same source, but with different contacts.  Linked cases included A0732483A, A0732491A, A0732492A, A0732500A, A0732501A, A0732515, A732528A, A0732533A, A0732539A, A0732540A, A0732936A, and A0732944A.
Sex: F
Vaccine: HEPA, TYP
Symptoms: Vulvovaginal mycotic infection
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of vaginal yeast infection in an adult female subject who was vaccinated HAVRIX, (GlaxoSmithKline).  Concurrent vaccination included TYPHOID vaccine, (manufacturer unspecified) given on 12 June 2008.  On 12 June 2008 at 17:00 the subject received 1st dose of HAVRIX at 1.0 ml.  On 18 June 2008, 6 days after vaccination with HAVRIX, the subject experienced vaginal yeast infection.  A systemic reaction.  At the time of reporting the events were unresolved.  The healthcare professional considered the events were unresolved.  The healthcare professional considered the events were possibly related to vaccination with HAVRIX.
Age: 10.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Accidental overdose, Incorrect dose administered, Inflammation
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of localized inflammatory reaction in a 10-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent vaccination given on 27 June 2008 included VARIVAX; Merck; unknown. Concurrent medications included ALBUTEROL. On 27 June 2008 at 10:30, the subject inadvertently received an adult dose of HAVRIX (1 ml, unknown, right arm), instead of the intended 1st dose of pediatric HAVRIX. This was considered to be an accident overdose. Follow-up information was received on 15 July 2008 via a healthcare professional, who reported that a physician ordered a pediatric dose of HAVRIX for the infant subject. After the subject left the clinic, the healthcare professional stated that she realized that the subject had accidentally been administered an adult dose of HAVRIX. The healthcare professional immediately notified the physician of the error and contacted a pharmacy and GlaxoSmithKline to inform them of possible implications. In addition, the healthcare professional informed the subject's mother of unspecified studies and advised her to monitor the infant for increased symptoms if fever and/or inflammatory reactions occurred. The healthcare professional indicated that the subject experienced a local inflammatory reaction at an unspecified time after vaccination with adult HAVRIX, and recommended treatment with TYLENOL or MOTRIN. The healthcare professional indicated that the immunization series was neither discontinued nor delayed, stating that the subject was scheduled to receive the 2nd dose of pediatric HAVRIX in six months. At the time of reporting the events were resolved.
Age: 17.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Vaginal infection
Clinical narrative: This case was reported by a physician and described the occurrence of vaginal yeast infection in a 17-year-old female subject who was vaccinated with HAVRIX 1440 (GlaxoSmithKline).  Concurrent medical conditions included borderline diabetes and gastroesoephageal reflux disease.  Concurrent vaccination given on 12 June 2008 included SALMONELLA TYPHI VI CAPSULAR POLYSACCHARIDE vaccine; Sanofi.  Concurrent medications included PREVACID.  On 12 June 2008 at 16:30, the subject received 1st dose of HAVRIX 1440 elisa units (unknown, right arm).  A physician reported stated that he decided to give the subject an adult dose of HAVRIX, as she presented to his office one month prior to her 18th birthday.  On 13 June 2008, one day after vaccination with HAVRIX 1440, the subject's mother contacted the physician and stated that her daughter had developed a vaginal infection.  The subject was taken to her primary care physician, where she was diagnosed with a yeast infection and started on DIFLUCAN therapy.  At the time of reporting, the events were improved.  The physician considered the events were unrelated to vaccination with HAVRIX 1440.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Anaphylactic reaction, Injection site pruritus, Injection site urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site hives in a 3 year-old female subject who was vaccinated with HAVRIX. Previous vaccinations included HEPATITIS A vaccine (manufacturer unspecified) given on an unknown date. There were no concurrent medications. On 10 June 2008, at 10:30 - 11:00, the subject received 2nd dose of HAVRIX at 0.5ml (720 elisa units) in an unknown thigh. On 11 June 2008, 1 day after vaccination with HAVRIX, the subject experienced hives initially around the injection site and then the trunk and arms. The subject experienced a systemic reaction. It was noted that the subjects 1st dose of HEPATITIS A vaccine previously received was from another manufacturer other than GSK based on the lot number. The subject returned to the physician's office on 13 June 2008 and was advised to take Benadryl. At that time, the hives were improved. The healthcare professional considered the hives were probably related to vaccination with HAVRIX. Follow-up information was received on 18 July 2008 via a healthcare professional, who reported that the subject received the 2nd dose of HAVRIX on 10 June 2008. On 11 June 2008, the subject's mother noticed hives at the injection site, which scattered to both arms, both legs, and on the subject's trunk. The hives were reported to be very itchy, but the subjects did not experienced a fever. As of 17 June 2008, the events were resolved. The reporting healthcare professional considered the events to be related to vaccination with HAVRIX.
Age: 66.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Convulsion, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional (also the subject) and described the occurrence of injection site redness in a 67-year-old female subject who was vaccinated with HEPATITIS A vaccine, (manufacturer unspecified), PNEUMOVAX.  Concurrent medical conditions included high blood pressure.  Concurrent medications included blood pressure medications.  On May 2008 at 11:00 the subject received 1st dose of HEPATITIS A vaccine in the right arm.  On the same date, the subject also received a one time dose of PNEUMOVAX.  Twenty four hours after vaccination with HEPATITIS A vaccine and an unspecified time after vaccination with PNEUMOVAX, the subject experienced injection site redness, heat at the injection site and swelling at the injection site.  She described this as a terrible reaction.  At the time of reporting the events were resolved.  The subject does not plan to continue the hepatitis A series. Follow-up 2/11/09 Still having Seizures & seeing a neurologist.
Sex: U
Vaccine: HEPA
Symptoms: Injection site pain
Clinical narrative: This case was reported by a healthcare professional, via a GSK sales representative, and described the occurrence of injection site soreness in an unspecified number of adult and children subjects of unspecified genders who were vaccinated with HAVRIX. In May 2008, The subject received unspecified number of Adults (Genders unspecified) experienced severe soreness at the injection site immediately following vaccination with HAVRIX 1440. It was unclear how long the pain continued post injection as the sales representative had limited to provide. At the time of reporting, the outcome of the event was unspecified. The healthcare reporter has received numerous reports of pain and stinging at the injection site when administering HAVRIX (AHAVB224AA) to both adults and children. No HAVRIX dose was provided for vaccination given to children. No redness or in duration appeared, but frequent complaints of site started administering a different lot of HAVRIX (AHAVB251AA) and continues to receive complaints of intense pain during and shortly thereafter giving the injection; more than one nurse noted the problem. The site started administering a different lot of HAVRIX (AHAVB251AA) and continues to receive complaints.
Age: 8.0
Sex: M
Vaccine: HEPA
Symptoms: Product quality issue, Urticaria
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of hive in a 8-year-old male subject who was vaccinated with HAVRIX, (GlaxoSmithKline).  There were no concurrent medications.  On 27 June 2008 at 17:00 the subject received 2nd dose of HAVRIX at 0.5 ml (720 elisa units) in the left arm.  On 27 June 2008, sometime after 19:00, the subject started to develop hives all over his body (a systemic reaction).  He was seen in the office the following day.  The hives were 1/2 mm in size.  The subject was treated with BENADRYL.  The subject had previously received HAVRIX without any problems.  At the time of reporting the hives were resolved.  The healthcare professional considered that the event was probably related to vaccination with HAVRIX.  The reporter stated that they did not want to use any of the remaining doses of HAVRIX from the same lot as the 2nd dose.  This was considered to be a product complaint.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Product quality issue, Urticaria
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of hives in a 3-year-old male subject who was vaccinated with HAVRIX for prophylaxis. There were no concurrent medications. On 27 June 2008 at 13:00 the subject received 1st dose of HAVRIX at 0.5 ml (720 elisa units) in right arm. On 27 June 2008, sometime after 19:00, the subject started to develop hives and urticaria all over his body (a systemic reaction). He was seen in the office the following day. The hives were 1 mm in size. The subject was treated with BENADRYL. At the time of reporting the hives and urticaria were improved. The healthcare professional considered that the events were probably related to vaccination from the same lot as this 1st dose of HAVRIX given. This was considered to be a product complaint.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Accidental overdose, Anorexia, Diarrhoea, Ear pain, Gastroenteritis
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of accidental overdose in a 5-year-old female subject who was vaccinated with HAVRIX 1440 (GlaxoSmithKline).  Concurrent vaccinations given on 16 July 2008 included INFANRIX, (GlaxoSmithKline); IPV, (Sanofi); MMR II, (Merck); and VARICELLA virus (Merck).  On 16 July 2008 at 11:30, the subject inadvertently received an adult dose of HAVRIX 1440 (unknown, left arm), instead of the intended 1st dose of pediatric HAVRIX.  This was considered to be an accidental overdose and a maladministration.  At the time of this report, the parents of the subject had not been contacted or notified.  Follow-up information received on 01 August 2008 indicated that the HAVRIX 1440 dose administered to the subject was given intramuscularly.  Concurrent IPV and Infanrix vaccine were also administered intramuscularly, MMR and VARICELLA vaccine were given subcutaneously.  Three days following administration of HAVRIX, on 19 July 2008, the subject was diagnosed with acute gastroenteritis.  The subject suffered from loose stools, anorexia, fever and headache.  The reporter felt that these events were possibly related to treatment with HAVRIX.  A day later, on 20 July 2008, the subject experienced right otitis externa with pain.  These events were not related to HAVRIX according to the reporter.  All events resolved by 21 July 2008.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Headache, Incorrect dose administered, Medication error, Otitis externa, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of accidental overdose in a 5-year-old female subject who was vaccinated with HAVRIX 1440 (GlaxoSmithKline).  Concurrent vaccinations given on 16 July 2008 included INFANRIX, (GlaxoSmithKline); IPV, (Sanofi); MMR II, (Merck); and VARICELLA virus (Merck).  On 16 July 2008 at 11:30, the subject inadvertently received an adult dose of HAVRIX 1440 (unknown, left arm), instead of the intended 1st dose of pediatric HAVRIX.  This was considered to be an accidental overdose and a maladministration.  At the time of this report, the parents of the subject had not been contacted or notified.  Follow-up information received on 01 August 2008 indicated that the HAVRIX 1440 dose administered to the subject was given intramuscularly.  Concurrent IPV and Infanrix vaccine were also administered intramuscularly, MMR and VARICELLA vaccine were given subcutaneously.  Three days following administration of HAVRIX, on 19 July 2008, the subject was diagnosed with acute gastroenteritis.  The subject suffered from loose stools, anorexia, fever and headache.  The reporter felt that these events were possibly related to treatment with HAVRIX.  A day later, on 20 July 2008, the subject experienced right otitis externa with pain.  These events were not related to HAVRIX according to the reporter.  All events resolved by 21 July 2008.
Sex: U
Vaccine: HEPA
Symptoms: Adverse event, Product quality issue
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of an unspecified, severe event in a pediatric subject of unspecified, severe event in a pediatric subject of unspecified age and gender who was vaccinated with HAVRIX. On an unspecified date the subject received unspecified dose of HAVRIX 0.5ml (prefilled syringe). At an unspecified time after vaccination with HAVRIX, the subject experienced an unspecified severe, adverse event. At the time of reporting the outcome of the event was unspecified. The reporter expressed concern over the quality of the vaccine as severe events occurred in two other pediatric subjects that received the same lot of HAVRIX (product complaint). For details surrounding the other two subjects, refer to case numbers A0741170A (master case - involving an event of seizure) and A0741173A (event unspecified).
Sex: U
Vaccine: HEPA
Symptoms: Adverse event, Product quality issue
Clinical narrative: This case was reported by a healthcare professional via a sale representative and described the occurrence of an unspecified, severe event in a pediatric subject of unspecified age and gender who was vaccinated with HAVRIX. On an unspecified date the subject received unspecified dose of HAVRIX at 0.5 ml (prefilled syringe). At an unspecified time after vaccination with HAVRIX, the subject experienced an unspecified, severe, adverse event. At the time of reporting the outcome of the event was unspecified. The reported expressed concern over the quality of the vaccine as severe events occurred in two other pediatric subjects that received the same lot of HAVRIX (product complaint). For details surrounding the other two subjects, refer to case numbers A0741170A (master case-involving an event of seizure) and A0741172A (event unspecified).
Age: 13.0
Sex: M
Vaccine: HEPA
Symptoms: Blood pressure decreased, Fatigue, Hyperhidrosis
Clinical narrative: This case was reported by a physician and described the occurrence of sweating in a 13-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). There were no concurrent medications. On the morning of 2 February 2008 the subject received 1st dose of HAVRIX at 0.5 ml in the left arm. An unspecified amount of time following vaccination with HAVRIX, the subject experienced sweating and feeling very tired. This resolved after 20 minutes. Then on the morning of 02 August 2008 (the subject was now 14 years old) the subject received a 2nd dose of HAVRIX at 0.5 ml in the left arm. Immediately afterwards, he experienced tiredness and sweating which lasted 10 minutes. His blood pressure remained within 90/50 (his normal is 110/55). After 20 minutes he felt better and was sent home. His blood pressure went back up to 96/53 (improved). Follow-up information was received on 04 September 2008 via a physician, which conflicted with the initial report. The physician reported that all of the events resolved after 20 minutes, but listed the date of onset as 08 May 2008, which differs from the previously reported vaccination dates. The physician indicated that the events were resolved and were possibly related to vaccination with HAVRIX. In addition, the physician stated that no action was taken other than rest for the subject.
Age: 1.6
Sex: M
Vaccine: HEPA
Symptoms: Petechiae, Purpura
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of purpura in a 19-month-old male subject who was vaccinated with HAVRIX for prophylaxis. There were no concurrent medications. On 12 August 2008 at 10:30 the subject received 1st dose of HAVRIX at 0.5 ml in the left thigh. Approximately 4 hours and 25 minutes later (on 12 August 2008), the subject developed a rash on the left leg posterior to the injection site. The rash was described as purpura and petechial. At the time of reporting the subject was at the office and had not received any treatment for the rash. The events were unresolved. Follow-up information was received on 21 August 2008 via a nurse, who reported that the events were resolved as of 13 August 2008. The reporting nurse considered the events to be possibly related to vaccination with HAVRIX
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Anaphylactic reaction
Clinical narrative: This case was reported by a physician and described the occurrence of anaphylaxis in a 1-year-old subject of unspecified gender who was vaccinated with HEPATITIS A vaccine. Concurrent medical conditions included egg allergy and peanut allergy. Concurrent vaccinations given on the same day (unspecified) as the Hepatitis A vaccine included three unspecified vaccines; manufacturer unspecified; unknown. On an unknown date, the subject received an unspecified dose of Hepatitis A (unknown) vaccine, the subject experienced anaphylaxis. A physician reported that a subject with egg and peanut allergies experienced an anaphylactic reaction on the same day that the subject was administered a Hepatitis A vaccine, followed by exposure to peanuts one hour after receiving the Hepatitis A dose. The physician contacted GSK to inquire if eggs were used in the manufacturing of, or were ingredient in HAVRIX. This case was assessed as medically serious by GSK. The reporting physician considered the event to be unrelated to vaccination with Hepatitis A vaccine. At the time of reporting the outcome of the event was unspecified. Follow-up information was received on 18 September 2008 via a physician, who stated that he did not need to report this due to the subject being allergic to peanuts, which she received after the Hepatitis A vaccination.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Accidental overdose, Irritability
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of an accidental overdose in a 1-year-old female subject who was vaccinated with HAVRIX for prophylaxis. Concurrent vaccination included MMR, PREVNAR and VARIVAX all given on 20 February 2008. On 20 February 2008 the subject inadvertently received 1st dose of HAVRIX at 1.0 ml (1440 elisa units). This was considered to be an accidental overdose. The same day, the subject became fussy. At the time of reporting, the event was resolved. Follow-up information was received on 12 September 21008 via a nurse, who reported that she had no further information to provide, as the incident did not happen at her clinic, nor was she involved with the incident. The nurse stated that she was only informed of the event via the subject's mother.
Age: 0.2
Sex: F
Vaccine: DTAP, HEPA, HIBV, IPV, PNC, RV5
Symptoms: Medication error, Pyrexia
Clinical narrative: This case was reported by a physician and described the occurrence of fever in a 2-month-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent vaccination included Act Hib vaccine Merck, TRIPEDIA, PREVNAR, IPOL and ROTATEQ all given on 3 July 2008. There were no concurrent medications. On 3 July 2008 the subject inadvertently received 1st dose of HAVRIX at 0.5 ml. There was considered to be a medication error as HAVRIX is not indicated for use in subjects under the age of 12 months. Immediately following vaccination with HAVRIX, on 3 July 2008, the subject developed a fever that resolved one day later on 4 July 2008. The physician considered the events of fever to probably related to vaccination with HAVRIX. Follow up information was received on 27 October 2008, via physician who reported the subject was a female who experienced the fever and medication error. The physician reported the subject's earliest sign or symptoms were experienced on 03 July 2008 and resolved on 04 July 2008. The physician stated the events were possibly related to HAVRIX or one of the other administered vaccine. It was reported that the immunization series with HAVRIX was delayed until the appropriate age.
Age: 52.0
Sex: F
Vaccine: HEPA
Symptoms: Haemorrhage, Laceration
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of bleeding from cut in a 52-year-old female subject who was vaccinated with HAVRIX 720. Concurrent medications included LEVOTHYROXINE. On 27 October 2008 at 11:00, the subject experienced bleeding from cut from broken vial of HAVRIX 720 (pharmaceutical product complain). The healthcare professional reported that when the medical assistant removed a vial of HAVRIX from the box and placed it on the counter, the bottom of the vial cracked and completely came apart from the vial. (pharmaceutical product complaint). Then when the reporter picked it up, she cut her right and left thumb. It is currently bleeding sporadically. At the time of reporting, the events were unresolved.
Age: 0.1
Sex: M
Vaccine: HEPA, HIBV, PNC, RV5
Symptoms: Irritability, Wrong drug administered
Clinical narrative: This case was reported by a physician and described the occurrence of fussiness in a 2-month-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). Previous and /or concurrent vaccination included PEDVAXHIB; Merck; unknown; unknown given on 7 November 2008; PREVNAR; Wyeth Labs; unknown given on 7 November 2008. On 7 November 2008 at 16:15, the subject received 1st dose of HAVRIX (.5 ml, unknown, left thigh). On 7 November 2008, at the time of vaccination with HAVRIX, the subject experienced wrong vaccine administered. On 08 November 2008, 1 day after vaccination with HAVRIX, the subject experienced fussiness. Physician reported a 2-month old infant received HAVRIX instead of PEDIARIX. The physician stated that 24 hours after the HAVRIX, HIB and PREVNAR vaccinations were given the subject's parent contacted a pediatric infectious disease physician because the subject was experiencing fussiness. The reporting physician feels that the fussiness is not due to the HAVRIX. The physician is unsure if the subject's fussiness has resolved. The subject was expected in the office to received PEDIARIX. At the time of reporting the outcome of the events were unspecified. The physician considered the events were not related to vaccination with HAVRIX. Follow-up information was received on 05 December 2008, via healthcare professional who reported the subject received HAVRIX instead of PEDIARIX. Other than fussiness, the subject did not have any adverse reactions. The reporting healthcare professional considered the events possibly related to vaccination with HAVRIX but also stated the fussiness my have been related to ROTATEQ, HIB or PREVNAR, which the subject also received. The onset dates was on 08 November 2008 and resolved the same day.
Age: 34.0
Sex: M
Vaccine: HEPA, IPV, MNQ, TYP
Symptoms: Erythema, Rash
Clinical narrative: The subject's medical history included high blood pressure and high cholesterol. Previous and/or concurrent vaccination included inactivated IPOL; unknown given on 30 April 2008; MENACTRA; unknown given on 30 April 2008. Concurrent medications included Unknown. On 30 April 2008, the subject received 1st dose of HAVRIX 1440 (unknown, left arm), unspecified dose of VIVOTIF (oral). On 3 May 2008, 3 days after vaccination with HAVRIX 1440, at an unspecified time after vaccination with VIVOTIF, the subject experienced rash. The subject received HAVRIX alone with other vaccines on 30 April 2008 prior to a trip. Three days later a rash developed under his arms and groin area. The rash was circular, red and not extensive. The subject contacted the healthcare professional who recommended a topical cortisone product. The subject traveled starting the 24 May 2008 for one week. The subject reported that the cortisone cream helped for a little bit, but then the rash became more generalized. Upon return, the subject saw a dermatologist and one of the spots on his arms was biopsies. The dermatologist determined the rash was vial and advised the subject not to complete the HAVRIX. The dermatologist gave an injection of a corticosteroid, provided topical cortisone type cream and "heavy duty cram" that he advised the subject not to use for more than 10 days. The subject's rash resolved by mid-June 2008. The healthcare professional considered the event was possibly related to vaccination with HAVRIX 1440 and VIVOTIF.
Age: 6.0
Sex: F
Vaccine: FLUN3, HEPA
Symptoms: Vaccination complication, Wrong technique in drug usage process
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of vaccination complication in a 6-year-old female subject who was vaccinated with HAVRIX for prophylaxis. Previous and/or concurrent vaccination included FLUMIST; manufacturer unspecified given on 21 November 2008. On 21 November 2008 at 15:45, the subject received 2nd dose of HAVRIX (.5 ml, unknown, left arm). On 21 November 2008, at the time of vaccination with HAVRIX, the subject experienced vaccination complication and accidental blood exposure. The reported noticed when the administering nurse drew back the syringe prior to injecting HAVRIX there was blood in the vaccine (vaccine complication). The vaccine was given in this manner and no adverse events have been experienced. At the time of reporting the outcome of the events were unspecified.
Age: 0.8
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Inappropriate schedule of drug administration, Pyrexia, Wrong drug administered
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a 10-month-old female subject who was vaccinated with HAVRIX, GlaxoSmithKline. A physician or other health care professional has not verified report. Previous and/or concurrent vaccination included FLUZONE, non-GSK; SANOFI; unknown given on 16 October 2008. On 16 October 2008 at 12:00, the subject received 1st dose of HAVRIX vaccine (unknown, left thigh). On 16 October 2008, less than one day after vaccination with HAVRIX, the subject experienced drug use for unapproved indication and wrong vaccine administered. On 31 October 2008, fifteen days after vaccination with HAVRIX, the subject experienced fever. The mother of a 10-month old subject reported that her physician intended to give a Hepatitis B vaccine but gave the subject a dose of HAVRIX instead. The subject was 10-months old at the time of immunization, which is below the recommended 1-year indication. The mother reported that two weeks later, the subject had a fever of 103 degrees which resolved. At the time of reporting the outcome of the events were resolved. Follow-up information was received on 24 November 2008, via physician who reported that HAVRIX 720 was given instead of Hepatitis B vaccine to a 10-month-old baby on16 October 2008. The physician advised the parent and the parent mentioned that the subject had a fever for 2 days about a week after the HAVRIX dose. The subject has not been seen in the office.
Age: 22.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Urticaria
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of hives in a 22-year-old female subject who was vaccinated with HAVRIX and influenza virus vaccine for prophylaxis. On 24 October 2008 the subject received 2nd dose of HAVRIX in the left arm and a dose of Flu vaccine (unknown manufacturer). Either that same day or the next day (25 October 2008) the subject developed hives. She presented to the office. The treating physician implied that the hives resolved, but the reporting sales representative was not certain, thus the resolution was reported as unknown. The physician was not certain whether the hives were caused by the HAVRIX or the concomitant flu vaccine given on the same date. The physician considered the event was possibly related to vaccination with HAVRIX and FLU vaccine. Follow-up information received on 19 December 2008 indicated that hives began on 24 October 2008. They resolved on an unknown date and were considered to be possibly related to treatment with HAVRIX.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, HEPA, PNC, RV5
Symptoms: Inappropriate schedule of drug administration, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of low grade fever in a 6-month-old male subject who was vaccinated with HAVRIX 720 for prophylaxis. The subject's medical history included allergic rhinitis and reflux unspecified. Previous and/or concurrent vaccinations included PEDIARIX; unknown given on 18 November 2008; PREVNAR; unknown given on 18 November 2008 and ROTATEQ; unknown given on 18 November 2008. On 18 November 2008 at 10:00, the subject received 1st dose of HAVRIX 720 (.5 ml, unknown, left thigh) and experienced drug use for unapproved indication. At an unspecified time after vaccination with HAVRIX 720, the subject experienced low grade fever. A 6-month-old subject received HAVRIX as ordered by a physician. The subject's mother was concerned about safety since the product is not recommended for 6-months of age. At the time of reporting. the events were unresolved. Follow-up information was received on 9 December 2008, via healthcare professional who reported the events resolved and were possibly related to vaccination with HAVRIX. The reporting healthcare professional associated the events with sinus congestion noted at the exam and erroneous administration given at 6-months of age.
Sex: U
Vaccine: HEPA
Symptoms: Abdominal pain, Drug exposure during pregnancy
Clinical narrative: This case was reported by a consumer and described the occurrence of colic in a neonate subject of unspecified gender who was exposed to HAVRIX given to the mother during pregnancy. A physician or other health care professional has not verified this report. In December 2006 the pregnant mother received 1st dose of HAVRIX. She was three months pregnant at the time and the fetus was exposed transplacentary to HAVRIX. At an unknown stage of gestation, mother gave birth to a normal neonate (no congenital defects reported) that was noted sometime later to have second dose of HAVRIX had not been given at the time of report.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Asthenia, Borrelia burgdorferi serology negative, Computerised tomogram normal, Dizziness
Clinical narrative: 10/12 - tingling in arms/legs, feeling weak, nauseated  10/13 - see doctor 1st time & twice more in Oct Oct - tingling in arms/legs, feeling weak, nausea but no vomiting, extreme tiredness, very dizzy, stomach ache Oct/Nov - saw neurologist & then in Dec began light sensitivity - on going today w/some robe  Jan/Feb saw neurologist & rheumatologist March = better but not "normal"
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Full blood count normal, Lumbar puncture, Nausea, Nuclear magnetic resonance imaging abnormal
Clinical narrative: 10/12 - tingling in arms/legs, feeling weak, nauseated  10/13 - see doctor 1st time & twice more in Oct Oct - tingling in arms/legs, feeling weak, nausea but no vomiting, extreme tiredness, very dizzy, stomach ache Oct/Nov - saw neurologist & then in Dec began light sensitivity - on going today w/some robe  Jan/Feb saw neurologist & rheumatologist March = better but not "normal"
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia, Photophobia, Thyroid function test normal
Clinical narrative: 10/12 - tingling in arms/legs, feeling weak, nauseated  10/13 - see doctor 1st time & twice more in Oct Oct - tingling in arms/legs, feeling weak, nausea but no vomiting, extreme tiredness, very dizzy, stomach ache Oct/Nov - saw neurologist & then in Dec began light sensitivity - on going today w/some robe  Jan/Feb saw neurologist & rheumatologist March = better but not "normal"
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Axonal neuropathy, Blood creatine phosphokinase increased, CSF protein increased, Demyelinating polyneuropathy, Electromyogram abnormal
Clinical narrative: Information has been received from a patients mother concerning her 12 year old daughter who, on an unknown date, was vaccinated with a dose of GARDASIL. Subsequently the patient experienced an "unknown neuromuscular condition" and was hospitalized. The patients mother reported that her 12 year old daughter was now crippled with a neuromuscular disorder caused from the HPV vaccines. She wears braces on both legs and uses a walker to walk with. She hardly moves or walks at all. She has been in the hospital twice in 6 weeks and was to go back into the hosp "this week" for a few days. The patients mother felt that the "unknown neuromuscular condition" was related to therapy with GARDASIL. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Gait disturbance, Muscle atrophy, Paraesthesia
Clinical narrative: Information has been received from a patients mother concerning her 12 year old daughter who, on an unknown date, was vaccinated with a dose of GARDASIL. Subsequently the patient experienced an "unknown neuromuscular condition" and was hospitalized. The patients mother reported that her 12 year old daughter was now crippled with a neuromuscular disorder caused from the HPV vaccines. She wears braces on both legs and uses a walker to walk with. She hardly moves or walks at all. She has been in the hospital twice in 6 weeks and was to go back into the hosp "this week" for a few days. The patients mother felt that the "unknown neuromuscular condition" was related to therapy with GARDASIL. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Gait disturbance, Mobility decreased, Neuromyopathy, Orthosis user, Walking aid user
Clinical narrative: Information has been received from a patients mother concerning her 12 year old daughter who, on an unknown date, was vaccinated with a dose of GARDASIL. Subsequently the patient experienced an "unknown neuromuscular condition" and was hospitalized. The patients mother reported that her 12 year old daughter was now crippled with a neuromuscular disorder caused from the HPV vaccines. She wears braces on both legs and uses a walker to walk with. She hardly moves or walks at all. She has been in the hospital twice in 6 weeks and was to go back into the hosp "this week" for a few days. The patients mother felt that the "unknown neuromuscular condition" was related to therapy with GARDASIL. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Balance disorder, Chronic inflammatory demyelinating polyradiculoneuropathy, Electromyogram, Gait disturbance, Laboratory test
Clinical narrative: Information has been received from a patients mother concerning her 12 year old daughter who, on an unknown date, was vaccinated with a dose of GARDASIL. Subsequently the patient experienced an "unknown neuromuscular condition" and was hospitalized. The patients mother reported that her 12 year old daughter was now crippled with a neuromuscular disorder caused from the HPV vaccines. She wears braces on both legs and uses a walker to walk with. She hardly moves or walks at all. She has been in the hospital twice in 6 weeks and was to go back into the hosp "this week" for a few days. The patients mother felt that the "unknown neuromuscular condition" was related to therapy with GARDASIL. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Lumbar puncture, Muscle atrophy, Nerve conduction studies, Nuclear magnetic resonance imaging, Syncope
Clinical narrative: Information has been received from a patients mother concerning her 12 year old daughter who, on an unknown date, was vaccinated with a dose of GARDASIL. Subsequently the patient experienced an "unknown neuromuscular condition" and was hospitalized. The patients mother reported that her 12 year old daughter was now crippled with a neuromuscular disorder caused from the HPV vaccines. She wears braces on both legs and uses a walker to walk with. She hardly moves or walks at all. She has been in the hospital twice in 6 weeks and was to go back into the hosp "this week" for a few days. The patients mother felt that the "unknown neuromuscular condition" was related to therapy with GARDASIL. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Walking aid user
Clinical narrative: Information has been received from a patients mother concerning her 12 year old daughter who, on an unknown date, was vaccinated with a dose of GARDASIL. Subsequently the patient experienced an "unknown neuromuscular condition" and was hospitalized. The patients mother reported that her 12 year old daughter was now crippled with a neuromuscular disorder caused from the HPV vaccines. She wears braces on both legs and uses a walker to walk with. She hardly moves or walks at all. She has been in the hospital twice in 6 weeks and was to go back into the hosp "this week" for a few days. The patients mother felt that the "unknown neuromuscular condition" was related to therapy with GARDASIL. No further information is available.
Age: 54.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Axillary pain, Headache, Hypoaesthesia, Injection site pain, Nausea
Clinical narrative: Left axillary pain 3 hrs after injection progressive swelling of axilla.  Numbness + tingling in fingers.
Age: 54.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Pyrexia, Swelling
Clinical narrative: Left axillary pain 3 hrs after injection progressive swelling of axilla.  Numbness + tingling in fingers.
Age: 54.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Axillary pain, Hypoaesthesia, Paraesthesia, Swelling
Clinical narrative: Left axillary pain 3 hrs after injection progressive swelling of axilla.  Numbness + tingling in fingers.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain, Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test negative, Urine human chorionic gonadotropin negative
Clinical narrative: Information has been received from a physician assistant and a licensed practical nurse, for GARDASIL, a Pregnancy Registry product, concerning a 20 year old female patient with asthma and a history of miscarriage and no known drug allergies or reactions who on 02-DEC-2008 was vaccinated with the first 0.5 ml IM dose of GARDASIL (lot #0152X).  Concomitant therapy included ALBUTEROL.  On 16-FEB-2009 the patient received the second 0.5 ml IM dose of GARDASIL (lot #01423X).  On 24-FEB-2008 the patient's mother reported that the patient experienced cramping and was in the emergency room.  An ultrasound was done and showed the patient was 6 weeks pregnant.  The office did not receive ER hospital records, so this was unconfirmed.  At the time of reporting, the outcome was unknown.  The patient also had a adverse experience after the first dose of GARDASIL (WAES # 0902USA04266).  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Drug exposure during pregnancy, Muscle spasms, Pregnancy, Ultrasound scan abnormal
Clinical narrative: Information has been received from a physician assistant and a licensed practical nurse, for GARDASIL, a Pregnancy Registry product, concerning a 20 year old female patient with asthma and a history of miscarriage and no known drug allergies or reactions who on 02-DEC-2008 was vaccinated with the first 0.5 ml IM dose of GARDASIL (lot #0152X).  Concomitant therapy included ALBUTEROL.  On 16-FEB-2009 the patient received the second 0.5 ml IM dose of GARDASIL (lot #01423X).  On 24-FEB-2008 the patient's mother reported that the patient experienced cramping and was in the emergency room.  An ultrasound was done and showed the patient was 6 weeks pregnant.  The office did not receive ER hospital records, so this was unconfirmed.  At the time of reporting, the outcome was unknown.  The patient also had a adverse experience after the first dose of GARDASIL (WAES # 0902USA04266).  Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Cough, Oxygen saturation decreased, Oxygen supplementation, Respiratory distress, Tachycardia
Clinical narrative: This case was received from a health care professional on 11 March 2009. A four-year-old male patient, with a history of milk allergy and ongoing left serous otitis, received the following vaccinations on 05 March 2009: a left thigh intramuscular fifth injection of TRIPEDIA (lot number reported as C2999AA, which corresponds to DAPTACEL); a left thigh intramuscular fourth dose of IPOL (lot number A0474-2); a right thigh subcutaneous second injection of MMR II (Merck, lot number 1571X); and a right thigh subcutaneous second injection of VARIVAX (Merck, lot number 1784X). Within three to five minutes post-vaccination, the patient developed a tight cough and progressive respiratory distress. He became tachypnic and tachycardic, with oxygen saturation 92% and blood pressure 82/42. Treatment included nebulizer treatments, DECADRON, BENADRYL, and supplemental oxygen, and the patient was transported to the hospital. He responded well to treatment, and the event subsequently recovered.