Age: 64.0
Sex: F
Vaccine: HEPA, TDAP, TYP, HEPA, TDAP, TYP
Symptoms: Nervousness
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of arm swelling (injection site) in a 64-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent medical conditions included codeine allergy (nausea) and sulfa allergy. Concurrent vaccination included tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed; GlaxoSmithKline; unknown; unknown given on 18 July 2013; typhoid vaccine (non-gsk); Sanofi; unknown; unknown given on 18 July 2013. On 18 July 2013 the subject received 1st dose of HAVRIX (1 unknown, unknown route, left arm). In the evening of 25 July 2013, 7 days after vaccination with HAVRIX, the subject experienced arm swelling (injection site). The reporter also described the arm swelling as "bumps on arm." The subject contacted the office where the vaccine was administered on 26 July 2013 and faxed a picture of the site. The subject was referred to another healthcare professional to have the site evaluated and the subject was given a steroid cream. At the time of reporting, it was unknown if the vaccination series was discontinued or delayed. The healthcare professional considered the event was clinically significant (or requiring intervention). At the time of reporting the outcome of the event was clinically significant (or requiring intervention). At the time of reporting the outcome of the event was unknown. No further details were available at the time of reporting as the subject left for foreign travel the following day. The healthcare professional considered the event was probably related to vaccination with HAVRIX. The nurse reported other cases with HAVRIX. See cases A1033622A and A1032762A for details on the other cases. GSK number A1035061A is a duplicate of A1035779A. All future correspondence will be submitted to A1035779A. On 19 September 2013, the nurse returned documentation that reflected two reporters who "reported on the same" subject. The follow up received from the case A1035061A is as follows: This case was reported by a healthcare professional (office manager) and described the occurrence of injection site reaction in arm in an unknown number of subjects of unspecified age and gender who were vaccinated with HAVRIX (GlaxoSmithKline). At an unspecified time after vaccination with HAVRIX,  the subjects experienced injection site reaction in arm (described as "weird feelings going down the arm"), feeling sick and shaking feeling. No additional details were available at the time of reporting. Outcome of the events were unknown. Additional follow up was received from a nurse on 9 August 2013. The nurse reported that the case had been reported to a regulatory agency. The nurse described the occurrence of injection site reaction in arm in a 64-year-old subject of unspecified gender. Concurrent vaccination included tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed; GlaxoSmithKline; intramuscular; unknown given on 18 July 2013; typhoid vaccine (non-gsk); non-GSK manufacturer; intramuscular; unknown given on 18 July 2013. On 18 July 2013, the subjects received 1st dose of HAVRIX (unknown details). The nurse reported that all adverse events began on 25 July 2013, 7 days after vaccination with HAVRIX. The nurse also reported that the subject experienced elevated red spot at the injection site (described as "4 raised, red areas at site"). The outcomes of all events were unknown. The nurse identified the suspect product as HAVRIX. The nurse did not consider the events as serious. The nurse documented that the events were not life threatening, did not involve severe or permanent disability, did not involve hospitalization, did not involve congenital anomaly and did not jeopardize the patient or require intervention. A biopsy was not performed. Alcohol and tobacco use was unknown to the nurse. It was unknown at the time of reporting if symptoms recurred following subsequent administration. The subject had not experienced adverse events following previous vaccinations. The initial reporter, the office manager, considered that the events jeopardized the subject or required making an intervention; therefore, GlaxoSmithKline considered this case to be serious.