Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site pruritus, Injection site pustule, Injection site reaction
Clinical narrative: Left shoulder became reddened (with multiple pustules and itching unmercifully); Left shoulder ( became reddened) with multiple pustules (and itching unmercifully); Itching on shoulder of injection site that she scratched until it was bleeding; Left shoulder (became reddened with multiple pustules and) itching unmercifully; Subcutaneous or intramuscular route of administration, nurse was not sure; This is spontaneous case initially reported by other health professional to Med Communications (reference number: SEQ19-04615) on 14-Oct-2019 with additional information (being process together) on 22-Oct-2019, concerning a female patient of unspecified age.  The patient's medical history and concomitant medications were not reported.  On 28-Aug-2019, the patient was administered Afluria Quadrivalent [Influenza vaccine; route of administration: subcutaneous or intramuscular (IM), not sure; anatomical location: left arm; dose, batch number and expiration date: not reported] (explicitly coded as Inappropriate route of vaccination') for influenza prophylaxis. It was reported that injection was routine, non-painful and uncomplicated.  On the same, date the patient's left shoulder become reddened, with multiple pustules and itched unmercifully. She stated that she had itching on the shoulder of injection site that she scratched until they were bleeding. The severe itching lasted for about a month.  On 02-Sep-2019, the patient was treated with Benadryl (diphenhydramine hydrochloride) and hydrocortisone cream due to the itching.  On an unspecified date, the patient was also treated with Tylenol (paracetamol) and antihistamines.  On 14-Oct-2019, the patient explicitly stated that this was not a localized injection site reaction, and that her symptoms were abated, but lingering, itching and discomfort were still were still present about once a week.    The outcome of events: 'Redness', 'Pustule', 'Itch' and skin bleeding' was recovered, on an unspecified date, according to additional information received from the patient.  Follow up received from other health professional via Med Communications (reference number: SEQ19-06013) on 05-Nov-2019: Route of administration and anatomical location added for Afluria; start date for Benadryl and hydrocortisone added; start dates for events updated; new event added. Narrative was updated accordingly.  Company Comment: The patient experienced erythema, pustule, skin haemorrhage and pruritus after incorrect route of the suspect product Afluria Quadrivalent administration. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.; Sender's Comments: The patient experienced erythema, pustule, skin haemorrhage and pruritus after incorrect route of the suspect product Afluria Quadrivalent administration. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.