Sex: U
Vaccine: FLUC4
Symptoms: Rash papular, Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Raised bump at the injection site/raised at the injection site; Warm to touch at the injection site; A three inch rash around the injection site; Itchy at the injection site; Redness 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: reported as 'full dose' and anatomical location: not reported) for influenza prophylaxis. The batch number was 283849 and expiry date: 30-Jun-2021. It was reported that the product had been stored in refrigeration and no temperature excursions had occurred with the vaccine. The vaccine was administered by nurse practitioner and there was no any leakage of vaccine.  On an unknown 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 the adverse reactions of redness, warm to touch and itchy at the injection site. There had been nothing in regards of treatment administered.   On an unspecified date in 2020, the patient recovered from all events. It was reported that the reactions had lasted longer than expected.  The reporter did not provide a causality assessment to Flucelvax QIV.  The reporter assessed the case as non-serious.  This case is linked to cases 202004573, 202004596, 202004597, 202004598, 202004599, 202004600, 202004601, 202004603, 202004604, 202004605 and 202004606 (the same reporter).   Additional information received on 25-Sep-2020 from other health professional: Additional details added for one reporter. Two new reporters added. Case changed from medically confirmed 'no' to 'yes. Dose description populated. Route of administration provided. Medical confirmation for the event of 'vaccination site lump' changed from 'no' to 'yes'. New events 'vaccination site erythema', ' vaccination site pruritus' and 'vaccination site warmth' added. 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): One reporter added. Reference numbers added. No changes in 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.