Sex: U
Vaccine: FLUC4
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: Raised bump at the injection site; Warm to touch at the injection site; A three inch rash at the injection site; Redness at the injection site; Itchy at the injection site; This spontaneous case was received on 18-Sep-2020 from other non-health professional via Agency (reference number: SEQW20-01953) and concerned a patient of unknown age and gender.  The patient's medical history and concomitant medications were not reported.   On an unspecified date in 2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, route of administration: intramuscular, dose: full dose as reported, anatomical location: not reported) for influenza prophylaxis. The batch number reported was 283849, expiry date: 30-Jun-2021. The product was stored in refrigeration and no temperature excursions occurred with the vaccines. The vaccine was administered by nurse practitioner without any leakage of vaccine.   On an unspecified date in 2020, during an injection of Flucelvax QIV, the patient developed a raised bump and a three-inch rash around the injection site. In addition, the patient experienced adverse reactions of redness, warm to touch, itchy and raised at the injection site. There had been nothing in regards of treatment administered. The reactions lasted longer then expected.   On an unspecified date in 2020, the patient recovered from all events.   The reporter did not provide a causality assessment.   The reporter assessed the case as non-serious.  This case is linked to cases 202004573, 202004596, 202004597, 202004598, 202004599, 202004600, 202004601, 202004602, 202004603, 202004605 and 202004606 (the same reporter).  Additional information received on 25-Sep-2020 from other health professional: Two reporters were provided and all events changed from medically confirmed 'NO' to 'YES'. Route of administration was provided. The events 'vaccination site redness', 'vaccination site warmth' and 'vaccination site pruritus' added. The outcome of the events 'vaccination site lump' and 'vaccination site rash' changed from 'unknown' to 'resolved'. Narrative amended accordingly.  Additional non-significant information received on 06-Jan-2021 from other non-health professional via Agency (reference number: SEQW21-00064): Additional reporter added. New reference numbers added. No changes in the narrative.  Company comment: The patient developed vaccination site mass, vaccination site rash, vaccination site pruritus, vaccination site erythema and vaccination site warmth after receiving the suspect product, Flucelvax QIV. Chronology is plausible. No information regarding concomitant medications and medical history was provided. Based on this information, causal relationship for all events is assessed as possibly related.; Sender's Comments: The patient developed vaccination site mass, vaccination site rash, vaccination site pruritus, vaccination site erythema and vaccination site warmth after receiving the suspect product, Flucelvax QIV. Chronology is plausible. No information regarding concomitant medications and medical history was provided. Based on this information, causal relationship for all events is assessed as possibly related.