Age: 62.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pustule, Injection site scar, Injection site ulcer
Clinical narrative: Scar at the injection site with a reddish-brown color, darker than the color of the skin, about half dollar size; [About 3 days after] the injection it was sore; [About 3 days after the injection it was sore and] pus was coming out of it; Infection injection site/ He had a hole and it got infected; This is a spontaneous case, initially received from other non-health professional on 07-May-2018, concerning a 62-year-old, adult, male patient.  The patient's historical condition included 3 times heart attack on an unspecified date in 2016, one heart attack recently (few months ago as reported) and back pain. The current condition included diabetes and high blood pressure (since an unspecified date). The concomitant medications included unspecified diabetic medication, unspecified blood pressure medication and unspecified back pain medication.  On 23-Sep-2017, the patient was administered Afluria (TIV) (influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: XT59205, expiry date: 16-May-2018) for prevention of flu and non-company suspect product Pneumovax (pneumococcal vaccine polysacch 23v, anatomical location: left arm, dose, route of administration, batch number and expiry date: not reported) for an unknown indication.   On 26-Sep-2017, 3 days after vaccination, the patient had a sore and hole at injection site which got infected and reported that pus was coming out of it. It was reported that, the patient was consulted with primary care physician (PCP) and treated with an antibiotic and cream but the patient did not take it. After 2-3 weeks of the onset of events, the patient developed a scar at the injection site about a half dollar size.   On an unspecified date in Oct-2017 (reported as 2-3 weeks after injection), the patient had recovered from the events (infection injection site, pain injection site, injection site pustule) with sequelae and had not recovered from the event injection site scar.   The reporter assessed this case as non-serious.  Follow-up report received from other non-health professional on 13-Jun-2018: The age of the patient, medical history (heart attack, back pain, diabetes and high blood pressure), concomitant medications (diabetic, blood pressure, back pain medications), the co-suspect product (pneumovax) and the start date of the event (infection injection site) (26-Sep-2017) were added. The indication for the suspect product (prevention for flu) was updated. The NDC number (33332-0017-01) was added in the additional information field. The new events (pain injection site, injection site pustule and injection site scar) were added. The outcome of the event (infection injection site) was changed from unknown to recovered with sequelae. The causality of the event was changed from unassessable to related. The narrative amended accordingly.  Update on 22-Jul-2018: Non-significant case correction was performed with IRD 13-Jun-2018: The case comment was corrected from "A 62-Year-old, male patient with historical condition heart attack, back pain and current condition included diabetes and high blood pressure, received influenza vaccine and developed infection injection site, pain injection site, injection site pustule and injection site scar after 3 days of vaccination. Considering the close temporal relationship, the causality of the events is assessed as related to the suspect vaccine" to " A 62-Year-old, male patient with current condition of diabetes and high blood pressure, developed infection injection site, pain injection site, injection site pustule and injection site scar, 3 days after vaccination with Afluria (TIV). Considering the close temporal relationship and localized injection site nature of the event, the causality of the events is assessed as related to the suspect vaccine".  Follow-up received from other health professional on 14-Dec-2018: The event injection site scar was made as diagnosis from symptom. It was reported that the patient still had the scar at the injection site with a reddish-brown colour, darker than the colour of the skin, about half dollar size, that was result of infection at the injection site. The reporter does not remember further details of the medications recommended by the doctor, so there is no further information regarding treatment measures associated with the event. The Narrative was amended accordingly.  Follow up received from non-health professional on 14-Jan-2019: The patient's name was added in the patient tab. It was reported that the event injection site infection cleared up 2-3 weeks after injection (unspecified date in Oct-2018). Therefore, stop date was updated as Oct-2018 for the event injection site infection. Med info number (SEQ19-00265) was updated in additional information tab. The narrative was amended accordingly.; Reporter's Comments: A 62-year-old male patient developed infection injection site, pain injection site and injection site pustule, 3 days after administration of Afluria (TIV). The patient also developed an injection site scar, 2-3 weeks after vaccination. The company assessed the causality of the events injection site, pain injection site and injection site as related due to the plausible temporal relationship between the events and the suspect vaccine and localized injection site nature of the event. The company assessed the causality of the event injection site scar as not related as it can be alternatively explained by the event injection site infection.