Age: 83.0
Sex: F
Vaccine: UNK
Symptoms: Product administered at inappropriate site, Skin warm
Clinical narrative: Arterial bleed into her deltoid muscle that was then festering; High dose of flu vaccine administered; Provider who administered the vaccine injected it into her artery; Arterial bleed into her deltoid muscle that was then festering; This is a spontaneous case, reported by other non-health professional to agency[reference number: SEQ19-07068] and initially received on 27-Nov-2019, concerning an 83-year-old, female patient.  The patient's medical history included rheumatoid arthritis, hypertension and diabetes. The patient was taking unspecified concomitant medications, however, the brand names were not provided.  On 05-Nov-2019, the patient was administered unspecified Flu vaccine [Influenza vaccine, batch number: 260397, route of administration: into the artery, anatomical location: right arm, dose reported as 'high' and expiration date: not reported] (explicitly coded as 'Inappropriate route of vaccination' and 'Inappropriate dose of vaccine administered') for influenza prophylaxis.  On 06-Nov-2019, one day after vaccination, the patient experienced slight soreness.   On an unspecified date in Nov-2019, reported as a week later, the patient had significant pain in her entire right arm.  On 22-Nov-2019, the patient was still experiencing severe pain, and she lost most of the ability to use her arm.  On 24-Nov-2019, the patient was taken to the emergency room (ER) due to severe edema, heat, hardness of her upper arm along with bruising from her shoulder to elbow. In the hospital it was noted that the vaccine was injected into patient's artery, causing arterial bleeding into the deltoid muscle that festered until the pain became unbearable. The patient started treatment with unspecified pain killers and antibiotic, and her blood thinners were stopped for a week. The patient was not hospitalised.   At the time of initial reporting, the patient had not recovered form the events. It was reported that the patient continued to have no use of right arm, and she still had heat, swelling and bruising from shoulder to arm, and was unable to use her cane.   The event of 'arterial bleeding' was assessed as serious (medically significant) per company.  The reporter did not provide causality assessment.  Company Comment: The patient experienced arterial haemorrhage and infection (reported as arterial bleed into her deltoid muscle that was then festering) after incorrect route and dose of product unspecified Flu vaccine administration. Chronology is plausible. Medical history of diabetes may have contributed to events. No concomitant medications were provided. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.; Sender's Comments: The patient experienced arterial haemorrhage and infection (reported as arterial bleed into her deltoid muscle that was then festering) after incorrect route and dose of product unspecified Flu vaccine administration. Chronology is plausible. Medical history of diabetes may have contributed to events. No concomitant medications were provided. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.