Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Blood urea increased, Diarrhoea, Differential white blood cell count, Fatigue, Full blood count
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of inadvertent overdose (asymptomatic) in a 76-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Previous and/or concurrent vaccination included FLULAVAL (GlaxoSmithKline; unknown; right arm) given on 17 September 2009 at 15:38. Concurrent medications included Hydrochlorothiazide, Potassium and Colchicine. On 17 September 2009 at 15:48, the subject received 2nd dose of FLULAVAL (.5 ml, unknown, right arm) and experienced inadvertent overdose (asymptomatic). The healthcare professional report that the subject was given FLULAVAL two times on the same day. The first vaccination was given at approximately 15:38 and the second was given about 10 minutes later. The subject has not had any immediate adverse reactions. Follow up information was received on 29 October 2009 via the nurse. Concurrent medical conditions included constipation and gout. Additional concurrent medications included Prednisone and EX-LAX. Following the subject's "double" flu shot with FLULAVAL on 17 September 2009, the physician had contacted the subject on 18 September 2009 at 15:45. The subject reported that on 17 September 2009 a couple of hours after receiving the vaccine that he felt shaky inside, but that it soon went away. The subject reported that he also had diarrhea briefly, but at the time of the physician's call 18 September 2009 he was fine. The physician asked the subject to call him if he had any possible side effects. The physician did not hear from the subject until the day of his appointment on 01 October 2009. The subject presented with fatigue. The subject's fatigue was described as improving, but still ongoing. The fatigue started two weeks ago. The subject reported that his fatigue moderately limited his activities. The frequency of his fatigue episode was daily. The fatigue was alleviated by resting and lying down for two to three hours helped. In addition, the subject presented with joint pain. The joint pain was ongoing. The subject also presented with diarrhea, and was described as improving. The subject reported that his diarrhea was sudden in onset. The subject reported to the physician that he normally had problems with constipation for which he took EX-LAX. Sometime after speaking to the physician on 18 September 2009, the subject again developed diarrhea. The diarrhea continued, but as of 01 October 2009, it had slowed down considerably. The subject denied nausea and vomiting with his complaint of diarrhea. The subject reported that the diarrhea had left him very weak and unable to work. The subject denied loss of appetite, chills, and fever with his complaint of fatigue. The subject reported that he was unable to work for a week (date unspecified), but was able to return to work two days prior to his appointment. The physician ordered a complete blood count (CBC), basic metabolic panel (BMP) and hepatic profile panel which was significant for potassium 3.3 (3.5-5.1), blood urea nitrogen (BUN) 27 (7-18) and creatinine 1.5 (0.8-1.3); otherwise the results were normal. The physician had scheduled a follow up appointment with the subject in two weeks from the time of his appointment (01 October 2009). The physician did not want to give the subject his PNEUMOVAX vaccination until the subject was 100 percent well. Relevant test results included complete blood count with differential, hepatic function panel, and basic metabolic panel on 01 October 2009. Laboratories were significant for potassium 3.3 mmol/L (3.5-5.1), BUN 27 mg/dl (70-110), glucose 112 mg/dl (70-110) and creatinine 1.5 mg/dl (0.8-1.3). Hepatic function pasn was within normal limits. The nurse reported that feeling of shakiness inside, diarrhea, fatigue, inability to work, feeling weak, joint pain, malaise, decreased ability to perform daily activities and overdose were not associated with a medical history or concurrent illness, lack of efficacy, or suspected transmission of an infectious agent via a medicinal product; but was associated with an erroneous administration. At the time of reporting the feeling of shakiness inside, diarrhea, fatigue, inability to work, feeling weak, joint pain, malaise, decreased ability to perform daily activities and overdose were resolved. The healthcare professional considered feeling of shakiness inside, diarrhea, fatigue, inability to work, feeling weak, joint pain, malaise, decreased ability to perform daily activities and overdose were probably related to vaccination with FLULAVAL.