Age: 51.0
Sex: F
Vaccine: HEPAB, TDAP, HEPAB, TDAP
Symptoms: Drug administered at inappropriate site, Incorrect route of drug administration, Injection site erythema, Injection site induration, Injection site nodule
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site soreness in a 51-year-old female subject (also a nurse) who was vaccinated with TWINRIX (GlaxoSmithKline), ENGERIX B. Concurrent medical conditions included allergic rhinitis, fibromyalgia, hemorrhoids, hyperthyroidism, rash, restless legs syndrome, rotator cuff injury, shoulder impingement syndrome, sleep apnea, uterine fibroid and vitamin d deficiency. Concurrent vaccination included tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed given on 16 March 2012 and HAVRIX (GlaxoSmithKline) given in an unknown deltoid on 11 April 2012. Concurrent medications included LEVOXINE, AMBIEN and Nasal medication (unspecified) (Nasal spray). On 16 March 2012 at 12:00 the subject received unspecified dose of TWINRIX in the right gluteal. The vaccine was administered at the inappropriate site. TWINRIX should be administered in the deltoid. It was reported that a one inch needle was used for the injection; therefore, TWINRIX administration may have resulted in subcutaneous injection. This was considered to be inappropriate route of vaccination. On 16 March 2012, less than one day after vaccination with TWINRIX, the subject experienced injection site soreness, injection site redness and hard nodule at the injection site. Injection site soreness and injection site redness resolved on unspecified dates. The hard nodule at the injection site was unresolved. Almost a month after TWINRIX administration, on 11 April 2012 at 12:50, the subject received unspecified dose of ENGERIX B in the left gluteal. The vaccine was administered at the inappropriate site. It was reported that the subject also received a dose of HAVRIX (unknown deltoid) on 11 April 2012. No adverse reactions were noted. Follow-up information was received on 13 June 2012 via healthcare professional who clarified the subject received ADACEL (0.5ml, intramuscular, left gluteal) and TWINRIX (1.0m, unknown, right gluteal) on 16 March 2012. The events onset date was 16 March 2012 and were local. It was reported that the subject insisted on where the injection site would be; given in the gluteal region due to fibromyalgia. The vaccine admin states "against lab recommendations". The healthcare professional reported the events to FDA (VAERS ID 453916). According to the VAERS report ADACEL was indicated as co-suspect vaccine. On 16 March 2012 the subject "was in need of Hepatitis B vaccination and insisted the vaccine be given in the glut due to fibromyalgia. Vaccine was administered as subject (who is also a nurse) requested. The subject had a local reaction with node, soreness, redness at site. The subject returned to the clinic for the 2nd dose and instructed it to be injected the same way". The subject reacted, but "a lot less" [injection site reaction[. The subject did not mention to her reactions healthcare professional until after receiving immunizations on 11 April 2012. On 11 April 2012 the subject received ENGERIX B 1.0ml, unknown, left gluteal) as well as HAVRIX (1.0mL, intramuscular, left deltoid). The reporting healthcare professional attributed the events to the subject's medical condition of fibromyalgia and "others" (not specified); this was an attempt to accommodate subject needs due to medical conditions. At the time of the report the events improved.