chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HEPAB
Symptoms: Injection site pain
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of stinging at the injection site in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of TWINRIX. At an unspecified time after vaccination with TWINRIX, the subject experienced stinging and burning at the injection site. This was also reported to be a product complaint as the reporter felt the events were related to a quality issue with the TWINRIX injection. The outcome of the events was unspecified. It was reported that 10 subjects (including this one) experienced burning and stinging at the injection site following administration of TWINRIX from the same lot. Linked cases include: A0752060A, A0752087A, A0752088A, A0752089A, A0752090A, A0752091A, A0752093A, A0752094A and A0752095A. Follow-up information was received on 04 November 2008, by a physician and described described the occurrence of injection site stinging in a male subject of 35 unspecified age unit who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of TWINRIX (unknown). On 29 September 2008, at an unspecified time after vaccination with TWINRIX, the subject experienced injection site stinging, injection site burning and product complaint. On 29 September 2008, the events were resolved. The physician considered the events were related to vaccination with TWINRIX. The physician associated the events to possible irritation substance in lot AHABB128AB. The lot was removed from vaccination circulation.
Age: 1.0
Sex: F
Vaccine: RUB
Symptoms: Pyrexia, Rubella antibody negative, Rubella antibody test
Clinical narrative: Information has been received from a consumer concerning herself with sensitivity to vaccines who received a dose of rubella virus vaccine live (Wistar RA 27/3) as a child when the patient was about a year old and experienced a high fever after getting the vaccine. She also mentioned that at age 18 she had a booster shot done because she had not developed immunity for rubella by titer test and had high fever as well. The patient did not seek medical attention. After getting the booster she had another titer test done and the 2nd shot did not take either. The patient was recovered on an unspecified date. This is one of several reports from the same source. No further information is available.
Sex: M
Vaccine: RUB, VARCEL
Symptoms: Hypovitaminosis, Pyrexia, Urine analysis abnormal
Clinical narrative: Information has been received from a consumer concerning her nephew who on an unspecified date was vaccinated with a dose of MERUVAX vaccine(Wistar RA 27/3). Secondary suspect therapy included VARIVAX vaccine (Oka/Merck) given on an unspecified date. It was reported that the patient developed "vitaminosis", high fever and his urine had extra protein. This is one of several cases from the same source. Additional information has been requested.
Sex: M
Vaccine: HEPAB
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer and described the occurrence of sick in a male subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified the report. On "January 26th", the subject received 1st dose of Twinrix (unknown). The subject's wife reported that he was on the accelerated "system". He missed the second dose due seven days later as she was "away" and was then sick for a week. At the time of reporting the outcomes of the event was unspecified. Please see A0768979A for a report of the subject's wife who also became sick.
Sex: U
Vaccine: HEPAB
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site pruritus
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of TWINRIX at 1.0 ml in an unknown arm. Immediately after vaccination with TWINRIX,  the subject experienced an achy sensation at the injection site that traveled down the arm to the wrist (pain radiating down arm). It was reported that the achy sensation resolved within 5 minutes as if it was from the injection. In the reporter's opinion, the events were probably related to treatment with TWINRIX. The reporter stated that this has been a trend that has been noted in multiple subjects receiving TWINRIX.
Sex: U
Vaccine: HEPAB
Symptoms: Hepatitis A antibody negative, Hepatitis B antibody negative
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of hepatitis b test negative in an adult subject of unspecified gender who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (TWINRIX, Glaxosmithkline). In 2008 the subject received the standard schedule of TWINRIX (unknown). In 2008, approximately six months after vaccination with the last dose of TWINRIX, the healthcare provider took titers and the subject did not show protective levels for hepatitis A, hepatitis B or both hepatitis A and B. Multiple subjects (approximately 17 - 18 subjects), who were sanitary workers were vaccinated during 2008 with the standard schedule of TWINRIX. Approximately six months after the last dose, the healthcare provider took titers and five subjects did not show protective levels for hepatitis Band six subjects did not show protective levels for hepatitis A. Some of these subjects showed non-protective titers for both A and B in the same subject. There were some vaccinated subjects in the group of 17-18 employees whose levels were "fine". Their local health department recommends that post-vaccination titers be done to prove protection.
Age: 65.0
Sex: F
Vaccine: HEPAB, IPV
Symptoms: Biopsy gingival, Gingival erythema, Gingival pain
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of gums red in an adult female subject who was vaccinated with TWINRIX, (GlaxoSmithKline).  Concurrent vaccination included poliomyelitis vaccine (manufacturer unspecified) given on February 2009.  In February 2009 the subject received unspecified dose of TWINRIX (unknown).  A few days after vaccination with TWINRIX, the subject went to her dentist for red and sore gums.  While at the dentist, the subject was told that she had white striations on her gums (white line on gum due to discoloration).  At the time of reporting the outcome of the events was unspecified.  Follow-up information received on 24 March 2009 indicated that the subject was a 65 year old female.  The events were reportedly resolved and indicated as possibly related to 2nd dose of TWINRIX, however, it was noted that a gum biopsy performed on an unspecified date indicated that the subject's gums and teeth were reacting to "filling" and not related to vaccine.  Additionally, it was reported that the onset of events was 26 January 2009, however, 2nd dose of TWINRIX was not administered until February 2009.  The 2nd dose of TWINRIX was given at 0.5 ml intramuscularly in the left deltoid.  Concurrent IPV vaccine (Sanofi) was given subcutaneously at 0.5 ml in the left arm.  Medical history reported included hypertension and PENICILLIN allergy (swelling).
Age: 35.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site atrophy, Skin discolouration
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of mark at injection site in a 35 year old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent vaccination included TWINRIX (Glaxosmithkline) given in the left arm on 23 February 2009 at 10:00. Concurrent medications included DEPOPROVERA.  On an unspecified date approximately one month ago, the subject received 1st dose of TWINRIX in the left arm. Soon after vaccination with TWINRIX, the subject developed a hole at the injection site and skin discoloration where the bandage was attached. The hole and the discoloration were unresolved at the time of reporting. The subject stated that the area was not painful and did not bother her. No bandage was applied after the 2nd injection in the same arm. It was noted that the reporter initially reported that the events took place following the 2nd administration with TWINRIX. She then corrected to say it was the 1st injection that triggered the events.
Age: 40.0
Sex: F
Vaccine: HEPAB
Symptoms: Haemorrhage, Immediate post-injection reaction
Clinical narrative: This case was reported by a consumer (also a sales representative) and described the occurrence of injection site hemorrhage in a 40-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included penicillin allergy and sulfa allergy. Concurrent medications included IBUPROFEN. On 10 March 2009 at 16:00 the subject received 1st dose of TWINRIX in the left arm. Immediately after vaccination with TWINRIX, the subject experienced a significant amount of bleeding. The physician applied pressure and then placed a band-aid on it. On 10 March 2009, the event resolved while the subject was still in office.
Age: 45.0
Sex: M
Vaccine: HEPAB
Symptoms: Immediate post-injection reaction, Injection site haemorrhage
Clinical narrative: The case was reported by a sales representative (also the wife of the subject) and described the occurrence of injection site hemorrhage in a 45-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject received no concurrent medications. On 11 March 2009 at 16:00 the subject received 1st dose of TWINRIX. Immediately after vaccination with TWINRIX, the subject experienced a significant amount of bleeding. The physician applied pressure and then placed a band-aid on it. On 11 March 2009, the event resolved while the subject was still in the office.
Sex: U
Vaccine: HEPAB
Symptoms: Pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of increased pain in an adult subject of unspecified gender who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (TWINRIX, Glaxosmithkline). On an unspecified date the subject received unspecified dose of TWINRIX (unknown). At an unspecified time after vaccination with TWINRIX, the subject experienced increased pain. The reporter commented that the administrating nurse lets the subject know that typically pain following TWINRIX injection lasts about one day, however, it lasted longer for this subject. At the time of reporting the outcome of the event was unspecified. It was reported that this event has occurred in multiple subjects.
Sex: U
Vaccine: HEPAB
Symptoms: Injection site pain
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of stinging at the injection site in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline).  On an unspecified date the subject received unspecified dose of TWINRIX.  At an unspecified time after vaccination with TWINRIX, the subject experienced stinging and burning at the injection site.  This was also reported to be a product complaint as the reporter felt the events were related to a quality issue with the TWINRIX injection.  The outcome of the events was unspecified.  It was reported that 10 subjects (including this one) experienced burning and stinging at the injection site following administration of TWINRIX from the same lot.  Linked cases include: A0752060A, A0752087A, A0752088A, A0752089A, A0752090A, A0752091A, A0752092A, A0750294A and A0752095A.
Age: 40.0
Sex: F
Vaccine: HEPAB
Symptoms: Vision blurred, Visual impairment
Clinical narrative: This case was reported by a physician and described the occurrence of transient visual disturbance in a 40-year-old female subject who was vaccinated with TWINRIX, GlaxoSmithKline. The subject's medical history included migraine headache. Previous vaccination included TWINRIX, GlaxoSmithKline given approximately one month prior to this event. The subject was taking no concurrent medications. On 3 April 2009 the subject received 2nd dose of TWINRIX (unknown route, left arm). On 3 April 2009, 1 hour after vaccination with TWINRIX, the subject experienced transient visual disturbances such as cloudy vision. On 3 April 2009, the events were resolved. The reporter does not know if she is going to complete the series.
Sex: U
Vaccine: HEPAB
Symptoms: Injection site pain
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of stinging at the injection site in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of TWINRIX. At an unspecified time after vaccination with TWINRIX, the subject experienced stinging and burning at the injection site. This was also reported to be a product complaint as the reporter felt the events were related to a quality issue with the TWINRIX injection. The outcome of the events was unspecified. It was reported that 10 subjects (including this one) experienced burning and stinging at the injection site following administration of TWINRIX from the same lot. Linked cases include: A0752060A, A0752087A, A0752088A, A0752089A, A0752090A, A0752091A, A0752092A, A0752093A and A0752095A.
Sex: U
Vaccine: HEPAB
Symptoms: Injection site pain
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of stinging at the injection site in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of TWINRIX. At an unspecified time after vaccination with TWINRIX, the subject experienced stinging and burning at the injection site. This was also reported to be a product complaint as the reporter felt the event were related to a quality issue with the TWINRIX injection. The outcome of the events was unspecified. It was reported that 10 subjects (including this one) experienced burning and stinging at injection site following administration of TWINRIX from the same lot. Linked cases include: A0752060A, A0752087A, A0752088A, A0752089A, A0752090A, A0752091A, A0752092A, A0752093A and A0752094A.
Age: 51.0
Sex: M
Vaccine: HEPAB
Symptoms: Hypersensitivity, Lip swelling, No reaction on previous exposure to drug
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of allergic reaction in a 51-year-old male subject who was vaccinated with TWINRIX. The subject's medical history included hypertension. Concurrent medications included DIOVAN. On 15 April 2009 at 15:00 the subject received 1st dose of TWINRIX (1 ml, unknown route, right arm). On 17 April 2009, 2 days after vaccination with TWINRIX, the subject experienced allergic reaction which was described as a swelling of the lips. The subject was treated with hydroxyzine. At the time of reporting the outcome of the events were was unspecified. The vaccination course with TWINRIX was discontinued. Follow-up received from the reporting healthcare professional on 15 May 2009: The subject had not experienced adverse events following previous vaccinations. TWINRIX was administered intramuscularly. The event of lip swelling occurred in the subject's upper lip. The events resolved on an unknown date. The reporting healthcare professional considered the events were possibly related to vaccination with TWINRIX.
Age: 51.0
Sex: F
Vaccine: HEPAB
Symptoms: Antibody test negative, Headache
Clinical narrative: This case was reported by a nurse and described the occurrence of not responding to therapy in a 51-year-old female subject who was vaccinated with Hep A + Hep B recombinant vaccine (GlaxoSmithKline) for prophylaxis. On unspecified dates, the subject received the full series of Hep A + Hep B and in 2008 she experienced not responding to therapy. On the morning of 6 October 2008, the subject received 1st dose of repeat series of Hep A + Hep B (1 cc, unknown, right arm) and that afternoon, she experienced a headache described as a dull throb in head. The nurse stated a female subject was vaccinated on the morning of 06 October 2008 with Hep A + Hep B and that afternoon developed a headache, which was further described as a dull throb in her head. These events did not require any treatment and did not last long. The reason Hep A + Hep B was being given was that she had the Hep A + Hep B series before but her body titers were negative when taken in 208. The timing of the previous series was not known. The subject did not have any reactions to Hep A + Hep B during her initial series. The nurse has consulted with the clinic physician and he did not feel this headache was a reason not to continue  the Hep A + Hep B series. Thus the Hep A + Hep B series will be continued as long as the subject is comfortable continuing. At the time of reporting the headache had resolved, the not responding to therapy was unspecified. The healthcare professional considered the events were possibly related to vaccination with Hep A + Hep B.
Sex: U
Vaccine: HEPAB
Symptoms: Antibody test negative, No therapeutic response
Clinical narrative: This case was reported by a nurse and described the occurrence of not responding to therapy in a subject (s) of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline).  On unspecified dates, the subject (s) received TWINRIX series (unknown).  At an unspecified time after vaccinations with TWINRIX, the subject (s) experienced not responding to therapy.  The nurse reported that they are seeing a trend, she estimated 6 or less subjects at their clinic, that get the TWINRIX series and are positive for antibodies initially and then a couple of years later when tested they have negative antibody titers.  The nurse stated that they do not know why the titers are negative and they do not known whether this is related to the TWINRIX or not.  The TWINRIX series is repeated in the subjects.  At the time of the reporting, there was no further information about the subjects.  At the time of reporting, the outcome of the event was unspecified.
Sex: U
Vaccine: HEPAB
Symptoms: Hepatitis A antibody negative, Hepatitis B antibody negative, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional via a GSK representative and described the occurrence of negative hepatitis A and B antibodies in a subject of unspecified age and gender who was vaccinated with TWINRIX, (GlaxoSmithKline).  On an unspecified date the subject received 1st dose, 2nd dose and 3rd dose of TWINRIX (details unknown).  At an unknown time after vaccination with TWINRIX, the subject had hepatitis A and B antibody titers taken, which were negative.  There was no further information available.
Sex: U
Vaccine: HEPAB
Symptoms: Hepatitis B antibody negative
Clinical narrative: This case was reported by a physician via a representative and described the occurrence of non-seroconversion in a subject of unspecified age and gender who was vaccinated with TWINRIX, (GlaxoSmithKline).  On an unspecified date the subject received unspecified dose of TWINRIX (unknown).  Approximately one month following the last dose of TWINRIX, hepatitis B titers were checked and it was noted that the subject was not seroprotected to hepatitis B.  Outcome was not provided.  The physician reported that 1 out of three subjects vaccinated with TWINRIX do not obtain seroprotection.  The physician works at a hepatitis C clinic and they use standard dosing of TWINRIX (0, 1 and 6 months).  They check hepatitis B titers 1 month after the last dose.  They vaccinated about 10 subjects a month and about 2 to 3 do not obtain seroprotection.
Age: 40.0
Sex: M
Vaccine: HEPAB
Symptoms: Therapeutic response decreased
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of decreased therapeutic response in a male subject aged between 40 and 49 years old who was vaccinated with TWINRIX, (GlaxoSmithKline).  There was no relevant medical history and no concomitant medications or vaccines.  On unspecified dates the subject received 1st dose, 2nd dose, 3rd dose of TWINRIX (details unknown).  In April 2009, at an unknown time after vaccination with TWINRIX the subject experienced decreased therapeutic response with low titers.
Age: 73.0
Sex: M
Vaccine: HEPAB
Symptoms: Dizziness, Headache, Vertigo
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of dizziness in a 73-year-old male subject who was vaccinated with TWINRIX, (GlaxoSmithKline). On 5 June 2009 the subject received 1st dose of TWINRIX (unknown route, right arm). At an unspecified time after vaccination with TWINRIX, the subject experienced dizziness, vertigo and headache. At the time of reporting the events were worse. The healthcare professional considered the events were possibly related to vaccination with TWINRIX.
Age: 44.0
Sex: M
Vaccine: HEPAB, IPV, TYP
Symptoms: Chromaturia
Clinical narrative: This case was reported by a pharmacist and described the occurrence of urine in dark yellow/orange in a 44-year-old male subject who was vaccinated with TWINRIX, (GlaxoSmithKline).  There was no relevant medical history.  The reporting pharmacist was not aware of any adverse events following previous vaccinations.  It was not known whether the subject was taking concomitant medications.  Concurrent vaccination included poliomyelitis vaccine inactivated (non-gsk); Sanofi Pasteur MSD given on 9 June 2009; typhoid vaccine (non-gsk); Sanofi Pasteur MSD given on 9 June 2009.  On 9 June 2009 at 09:30 the subject received 1st dose of TWINRIX (1 ml, unknown route, right arm).  Seven to ten days (the exact date was unknown) after vaccination with TWINRIX, the subject experienced dark yellow to orange color urine.  The event resolved after 10 days.  The pharmacist considered the event was possibly related to vaccination with TWINRIX.
Age: 48.0
Sex: F
Vaccine: HEPAB
Symptoms: Flushing, Hypoaesthesia oral, Immediate post-injection reaction, Paraesthesia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm tingling in a 48-year-old female subject who was vaccinated with TWINRIX, (GlaxoSmithKline).  On 7 November 2008, the subject received unspecified dose of TWINRIX (1 ml, unknown, left arm).  On 7 November 2008, immediately after vaccination with TWINRIX, the subject experienced arm tingling, jaw numbness, arm numbness, facial flushing and pharmaceutical product complaint.  The healthcare professional reported that a female subject received a TWINRIX vaccination on the morning of 07 November 2008 and developed immediate symptoms of tingling, numbness of her left jaw, and facial flushing.  The emergency medical service (EMS) was called and the subject was transported to the hospital.  The healthcare professional was concerned over a called and the subject was transported to the hospital.  The healthcare professional was concerned over a potential quality issue with vaccine.  At the time of reporting the outcome of the events were unspecified.  The healthcare professional considered the events were probably related to vaccination with TWINRIX.  TWINRIX lot number was reported as "AHAVB140AA".  The healthcare professional reported another subject see case A0757114A.
Age: 48.0
Sex: F
Vaccine: HEPAB
Symptoms: Pruritus, Rash
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of localized rash on back in a female subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline).  On 19 January 2009 the subject received unspecified dose of TWINRIX (1 ml, unknown).  On 20 January 2009, 1 day after vaccination with TWINRIX, the subject experienced localized rash on back.  The subject denied any itching or associated pain.  At the time of reporting the outcome of the event was unspecified.  Follow-up information received on 06 February 2009 indicated that the subject was a 48 year old female.  The rash began on 20 January 2009 and was improved by 23 January 2009.  In the reporter's opinion, the rash was possibly related to treatment with TWINRIX.  The subject also experienced itching.  The onset, outcome and relationship to TWINRIX was not reported.  The 1st dose of TWINRIX was administered on 24 November 2008.
Sex: F
Vaccine: HEPAB
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer and described the occurrence of sick in a female subject of unspecified age who was vaccinated with TWINRIX (Glaxosmithkline). A physician or other health care professional has not verified this report. On "January 26th", the subject received 1st dose of TWINRIX (unknown). The subject reported that she was on the accelerated "system". She missed the second dose due seven days later as she was "away" and was then sick for a week.  At the time of reporting the outcome of the event was unspecified. Please see A0768986A for a report of the subject's husband who also became sick.
Age: 22.0
Sex: M
Vaccine: HEPAB
Symptoms: Condition aggravated, Rash generalised
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of rash aggravated in a male subject of unspecified age who was vaccinated with Twinrix (GlaxoSmithKline). At the time of reporting, the subject was a prisoner. There was no information provided regarding concomitant medications or medical history. Previous vaccination included 1st and 2nd dose of Twinrix (GlaxoSmithKline) given on unknown dates in 2009. The subject has had a worsening rash over the past 6 months. The only thing the healthcare professional could correlate it with was the Twinrix vaccination. The rash seemed to get worse after each injection and then would subside until receiving the next injections. On 23 July 2009 the subject received 3rd dose of Twinrix (detail unknown). On 31 July 2009, 8 days after vaccination with Twinrix, the subject experienced rash aggravated. A the time of reporting the outcome of the event was unspecified. Follow-up information was received on 31 August 2009, via physician's assistant, who reported a 23 year old male 2009 and it became worse with the 3rd injection. The physician's assistant considered the event may have been to Twinrix. Further evaluation of his records revealed that his rash wasn't reported until 01 May 2009, well after the first and second doses". The subject was referred to dermatology.
Age: 1.3
Sex: M
Vaccine: RUB
Symptoms: Pyrexia, Rash, Vaccination complication
Clinical narrative: Information has been received from a consumer concerning his 15 month old son with no pertinent medical history and no pertinent medical history and no known drug allergies/drug reactions who on an unspecified date was vaccinated with a dose of MERUVAX II. There was no concomitant medication reported. It was reported that "same day of the vaccination" the patient developed slight fever and some rash. There were no laboratory diagnostic tests performed. The patient did not seek medical attention. It was reported that the patient recovered 2 or 3 days after the vaccination. The reporter indicated that the patient also experienced an adverse experience following another vaccination. WAES # 0905USA01274. Additional information has been requested.
Age: 38.0
Sex: M
Vaccine: HEPAB
Symptoms: Biopsy, Lichen planus
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of lichen planus in a 38 year old male subject who was vaccinated with TWINRIX (Glaxosmithkline). A physician or other healthcare professional has not verified this report. On an unspecified date the subject received unspecified dose of TWINRIX (unknown). At an unspecified time after vaccination with TWINRIX, the subject experienced lichen planus. At the time of reporting the event was unresolved. The reporter stated that this event occurred months ago. Follow-up information was received on 01 September 2009, via healthcare professional, who reported the Lichen planus onset date was 07 January 2009. Biopsy was performed. At the time of the report, the event was unresolved. The healthcare professional considered the event possibly related to vaccination with TWINRIX.
Sex: U
Vaccine: RUB
Symptoms: Malaise, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her child who in earlier 2009 was vaccinated with MERUVAX II (lot number, route and site not reported).  Subsequently patient developed a bad fever and was "all out of sorts" after getting vaccine.  It was unknown if the patient sought medical attention.  The outcome was not reported.  The patient also had a reaction to ATTENUVAX (MSD, WAES0905USA03195).  No further information is available.
Sex: U
Vaccine: HEPAB
Symptoms: Hepatitis B antibody negative
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hepatitis b antibody negative in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medical conditions included HIV positive. On an unspecified date, the subject received 1st dose, 2nd dose of TWINRIX (unknown). On an unspecified date in 2009, six to eight weeks prior to the time of reporting, the subject received 3rd dose of TWINRIX (unknown). On an unspecified date after vaccination with TWINRIX, the subject had a negatives hepatitis b titer. The subject had a positive titer to hepatitis A. The subject was referred from a medical facility to get re vaccinated because of the negative hepatitis B titer. Follow-up information was received on 17 September 2009, via healthcare professional who reported the subject did not experience "any event, subject was a non-responder due to immunocompromised state."
Age: 55.0
Sex: M
Vaccine: HEPAB
Symptoms: Muscular weakness, Paraesthesia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of muscle weakness right-sided in a 55-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). On 7 August 2009 the subject received 1st dose of Twinrix (1ml, unknown, right arm). On 7 August 2009, less than one day after vaccination with Twinrix, the subject experienced muscle weakness right-sided and radiating tingling down right arm to fingers. The subject's symptoms were only on the right side. At the time of reporting, the outcome of the radiating tingling down the arm to fingers was worse. The outcome of muscle was unknown. The healthcare professional considered the events were possibly related to vaccination with Twinrix. The healthcare professional called the CDC and was referred to GSK.
Sex: F
Vaccine: RUB
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a Doctor of pharmacy concerning a female baby (1-2) days old who on approximately on 05-JUL-2009 was vaccinated with MERUVAX II (lot # not reported) instead HEPATITIS B (manufacturer unknown). Reported as human error. On an unspecified date she received HEPATITIS B (manufacturer unknown) (lot # not reported). No adverse effects were reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of two reports from the same source.
Sex: U
Vaccine: HEPAB
Symptoms: Feeling hot
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of heat sensation in arm in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of TWINRIX (unknown). On an unspecified time after vaccination with TWINRIX, the subject experienced heat sensation in arm. At the time of reporting the outcome of the event was unspecified. A traveling nurse reported that she was aware of several subjects who after being vaccinated with TWINRIX (pre-filled syringe) experienced heat down the arm which did not last long.
Age: 1.4
Sex: F
Vaccine: RUB
Symptoms: Feeling abnormal, Immediate post-injection reaction, Malaise, Measles, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her approximately 17 month old female daughter with a history of "had a high fever" to unknown vaccine by unspecified manufacturer and "hand-foot-mouth night of vaccination to unspecified vaccine or manufacturer but different than the one in which she experienced a high fever" and who experienced sickness, measles, fussiness, fever, and rash while on therapy with measles virus vaccine live (WAES # 0907USA01311) who in the spring of 2008, was vaccinated with a dose of rubella virus vaccine live (Wistar RA 27/3) (dose and lot # not reported). There was no concomitant medication. Subsequently, the patient had an immediate reaction. The specific reaction was not remembered but the consumer did remember it was not as a severe reaction as the one after vaccination with measles virus vaccine live (MSD). The consumer was unsure if her daughter went into the office with this reaction or if the medical attention was over the phone. No lab diagnostics studies were performed. On unspecified date, the patient recovered.
Age: 1.4
Sex: F
Vaccine: RUB
Symptoms: Rash
Clinical narrative: Information has been received from a consumer concerning her approximately 17 month old female daughter with a history of "had a high fever" to unknown vaccine by unspecified manufacturer and "hand-foot-mouth night of vaccination to unspecified vaccine or manufacturer but different than the one in which she experienced a high fever" and who experienced sickness, measles, fussiness, fever, and rash while on therapy with measles virus vaccine live (WAES # 0907USA01311) who in the spring of 2008, was vaccinated with a dose of rubella virus vaccine live (Wistar RA 27/3) (dose and lot # not reported). There was no concomitant medication. Subsequently, the patient had an immediate reaction. The specific reaction was not remembered but the consumer did remember it was not as a severe reaction as the one after vaccination with measles virus vaccine live (MSD). The consumer was unsure if her daughter went into the office with this reaction or if the medical attention was over the phone. No lab diagnostics studies were performed. On unspecified date, the patient recovered.
Sex: F
Vaccine: RUB
Symptoms: Incorrect drug dosage form administered
Clinical narrative: Information has been received from a Doctor of pharmacy concerning a female baby (1-2) days old who on approximately on 05-July-2009 was vaccinated with RUBELLA (lot # not reported) instead YEAST (manufacturer unknown). Reported as human error. On an unspecified date she received YEAST (manufacturer unknown) (lot # not reported). No adverse effects were reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 2.0
Sex: F
Vaccine: RUB
Symptoms: Diarrhoea, Rash pruritic, Urticaria
Clinical narrative: Information has been received from a consumer concerning her 29 month old daughter with possible allergy to MOTRIN and no pertinent medical history who on 20-JUL-2009 was vaccinated with a 0.5 ml dose of MERUVAX II (lot # 661767/1198X) in the thigh. Concomitant therapy included multivitamins. On 21-JUL-2009, "the next day", the patient experienced a rash with hives and itching on both arms. On approximately 27-JUL-2009, "the week of 27-JUL-2009", the patient had diarrhea after swimming in a pool. Twelve days after the vaccination, the patient had "dime sized hives that looked like mosquito bites" on her body and legs. The doctor was phoned and said it was probably viral or from the swimming pool. The doctor did not feel it was associated with the vaccination. The patient was treated with oatmeal baths and BENADRYL. No lab tests were done. At the time of this report, the patient's symptoms persisted. No further information is available.
Age: 32.0
Sex: F
Vaccine: HEPAB
Symptoms: Fatigue, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of nausea in a 32-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). On 2 September 2009 and 14 September 2009 the subject received 1st dose adn 2nd dose of TWINRIX (1 ml, unknown, left arm). On 4 September 2009, after starting 'low dose birth control' and 1 hour after vaccination with TWINRIX, the subject experienced nausea and vomiting. On 14 September 2009, 1 hour after vaccination with TWINRIX, the subject experienced nausea and vomiting. The subject started to take low dose birth control on the same date as the initial TWINRIX injection. The nausea and vomiting resolved within one hour of the first injection on 4 September 2009. I was unknown how long the nausea and vomiting lasted after the second TWINRIX injection. At the time of reporting the outcome of the nausea and vomiting after the 2nd dose of TWINRIX events were unspecified. Follow-up information was received on 15 September 2009, via sales representative, who reported the subject still had a headache, fatigue slight fever, but is no longer vomiting. The subject is not taking LOESTRIN, but is using a topical CLEOCIN T. Follow-up information received on 25 September 2009, via nurse practitioner who stated that she thinks that the subject was malingering when she complained about her symptoms. She believes that subject wanted to get out of work and that is why she complained. Follow-up information received on 30 September 2009, indicated that the events resolved and were considered possibly related to treatment with TWINRIX.
Sex: U
Vaccine: FLUX, MU, RUB
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a medical assistant concerning a patient who was vaccinated with WISTAR RA 27/3 or JERYL LYNN. Concomitant therapy included "Flu-shot and possibly other vaccines were given." On "07-NOV-2008" the physician sent the patient to the Emergency Room after receiving either WISTAR RA 27/3 or JERYL LYNN vaccines. The patient had sought medical attention. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: RUB
Symptoms: Fatigue, Vomiting
Clinical narrative: Information has been received from a consumer concerning her 4 year old son with no pertinent medical history, no drug reactions/allergies, who in 2007, was vaccinated with a first dose of MERUVAX II. On 27-FEB-2009, the patient was vaccinated with a second dose of MERUVAX II. There was no concomitant medication. "4 hours after receiving the MERUVAX II, the patient experienced vomiting for 4 to 5 times. The patient had been seen getting tired easily lately. The reporter called the physician office. On an unspecified date, the patient recovered. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: RUB
Symptoms: Lethargy, Pyrexia
Clinical narrative: Information has been received from a consumer concerning a 12 month old son with birth defect where he had "a hole in his heart" and no allergies who on 03-MAR-2009 was vaccinated with a dose of MERUVAX II (lot number not available). Subsequently, the patient developed fever and became lethargic two hours after receiving MERUVAX II on 03-MAR-2009. He was brought to the emergency room on 04-MAR-2009 but was not admitted in the hospital and was sent home the same day. The consumer noted that she and her husband had stomach flu a week prior to the time when the patient got the MERUVAX II. The physician at the hospital thought that it could be the reason of patient's symptoms but the mother did not want to believe that because the patient did not show any demonstration of being affected of the stomach flu prior to him receiving the MERUVAX II. The patient recovered four days after having the symptoms on 07-MAR-2009. The patient sought unspecified medical attention. Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HBHEPB, PNC, RV5
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a consumer concerning her 4 month old daughter with no pertinent medical history and no known drug allergies/drug reactions who on 05 Mar 2009 was vaccinated with a dose of hepatitis B virus vaccine rHBsAg + Hib conj vaccine (OMPC) (Lot # 655548/1243F) intramuscularly. Secondary suspect therapy included rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (MSD). Other concomitant therapy given on  the same day included the second dose of PEDIARIX ("the first dose was given at 2 months of age") and a dose of PREVAR. It was reported that her daughter developed a "slight rash and fever for a few days after the vaccinations". The patient sought medical attention with an office visit. There was no laboratory diagnostic tests performed. it was reported that the patient had recovered "a few days later.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Crying, Drug administered at inappropriate site, Immediate post-injection reaction
Clinical narrative: This case was reported by a physician and described the occurrence of crying in a 11-year-old male subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline). The subject's medical history included enuresis. Concurrent vaccination given on 03 June 2008 included VARIVAX, (manufacturer unspecified). Concurrent medications included Imipramine. On 03 June 2008 at 17:15, the subject received the 1st dose of BOOSTRIX (.5 ml, intramuscular, left thigh). Immediately after vaccination with BOOSTRIX, the subject experienced crying. The subject received the BOOSTRIX injection in the left thigh, rather than the recommended deltoid muscle of the upper arm. At the time of reporting, the outcome of the events was unspecified.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site movement impairment, Muscle spasms, Wrong drug administered
Clinical narrative: This case was reported by a physician and described the occurrence of muscle spasm at injection in a 50-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 5 June 2008 the subject received unspecified dose of BOOSTRIX at 0.5 ml in the left arm. At an unspecified time after vaccination with BOOSTRIX, the subject experienced muscle spasms at injection. At the time of reporting the event was unresolved. Administration of BOOSTRIX to this subject was also considered to be a medication error as BOOSTRIX is not indicated for use in subjects over the age of 18 years.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Drug administration error, Hearing impaired, Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a physician and described the occurrence of a medication error in a 32-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On the morning of 24 September 2008, the subject inadvertently received a 2nd dose of Boostrix. This was considered to be a maladminstration (asymptomatic/ extra dose given). It was also considered to be a medication error as Boostrix is not indicated for use in subjects over the age of 18 years and this subject received two doses of Boostrix in her 30's. The 1st dose was administered approximately one year prior in 2007. No adverse events were reported. The reporter commented that they have given Boostrix to many of their adult patients. No specifics were provided.  Follow-up information received on 24 October 2008 indicated that in October 2008, the subject developed hearing issues. The reporter stated that voices and everything sounds very loud and things are muffled and not clear sounding. The physician checked the subject's ears and reported that they were fine with no sign of infection. At the time of reporting, the outcome of the events was unspecified. 01 December 2008, follow-up information was received from the reporting physician. The subject did not use alcohol or tobacco. The first and second doses of Boostrix were administered intramuscularly. The second dose of Boostrix (0.5mL) was given on 17 September 2007 in the left deltoid. Onset date of the events was reported as "after vaccination?". The outcome of the events was unknown. Relationship to Boostrix was unknown. The physician considered the events could have been associated with erroneous administration: the subject received DTAP twice within one years time.
Age: 0.16
Sex: F
Vaccine: TDAP
Symptoms: Cough, Nasopharyngitis, Wrong drug administered
Clinical narrative: This case was reported by a grandfather of a consumer and described the occurrence of wrong vaccine administration in a 2-month-old female subject who was vaccinated with (BOOSTRIX, GlaxoSmithKline). A physician or other health care professional has not verified this report. On 12 December 2008 the subject inadvertently received a dose of BOOSTRIX at 0.5 ml in the right thigh. This was the wrong vaccine. The subject should have received INFANRIX. The child was taken to the hospital several days later due to cough and cold. At the time of reporting the outcome of the events was unspecified.
Sex: F
Vaccine: TDAP
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of nonspecific reaction in a female subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline) for prophylaxis. On an unspecified date the subject received unspecified dose of BOOSTRIX (.5 ml. unknown). In 2009, at an unspecified time after vaccination with BOOSTRIX, the subject experienced nonspecific reaction. The medical assistant reported that two subjects reacted to BOOSTRIX. No specific complaints about the appearance or characteristics of the BOOSTRIX were provided. The sales representative had limited information. She could not provide details on the type of reaction the subjects experienced or whether the reaction was local or systemic. The reporter believed that a quality assurance problem may have caused the adverse event. No specific physical complaints with the product's appearance, etc. were provided. The medical assistant just thought that presentation of BOOSTRIX (vial or prefilled syringe) was used. Please see A0774667A for the second report of unspecified reaction to BOOSTRIX. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the unspecified reaction was possibly related to vaccination with BOOSTRIX. Follow-up received as quality statement performed on 15 May 2009: As per quality statement, the BOOSTRIX vaccine lot AC52B031AB met the requirements of the specifications and was confirmed as suitable for vaccination purpose.