Age: 48.0
Sex: F
Vaccine: FLUC4, HEP, HEPA, TDAP, HEP, HEPA, TDAP, UNK
Symptoms: Contusion, Fatigue, Haematocrit decreased, Haemoglobin decreased, Impaired work ability
Clinical narrative: Flucelvax Quadrivalent and Vaqta were administered on the same date, at the same anatomical location; Plenty of bruises in her arms and all over her body; Feels so tired; Hematocrit 31.8; Hemoglobin 10.6; RBC 3.54; Lymphocytes 18.9; This spontaneous case was retrieved on 04-Mar-2024 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2741109-1), reported by other healthcare professional and concerned a 48-year-old female patient.    The patient had no relevant medical history and was not taking any concomitant medications.  On 18-Jan-2024, the patient was vaccinated with non-company co-suspect Engerix b (hepatitis b vaccine rHBsAg (yeast); dose: reported as '1'; route of administration: intramuscular (IM); anatomical location: left arm (LA); indication: not reported); the batch number reported was 9452S, with non-company co-suspect Vaqta (hepatitis a vaccine inact; dose: reported as '1', route of administration: intramuscular (IM); anatomical location: right arm (RA); indication: not reported); the batch number reported was X015720, and with non-company co-suspect Boostrix (Diphtheria vaccine toxoid, Pertussis vaccine acellular 3-component, Tetanus vaccine toxoid; dose: reported as '1'; route of administration: intramuscular (IM); anatomical location: left arm (LA); indication: not reported); the batch number reported was 324B2.  On the same date, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4V; dose: reported as '1', route of administration: intramuscular (IM); anatomical location: right arm (RA); indication: not reported) (explicitly coded as 'Product administration error'). The batch number reported was 370658.  On an unspecified date in Jan-2024, an unknown amount of time after receiving Flucelvax Quadrivalent and non-company co-suspect vaccines Engerix b, Vaqta, and Boostrix,  the patient developed plenty of bruises on her arms and all over her body, and the patient felt so tired, she couldn't get up for work. The patient also experienced haematocrit decreased, haemoglobin decreased, red blood cell count decreased and lymphocyte percentage decreased. Laboratory tests were ordered for red blood cell count 3.54, hemoglobin 10.6, hematocrit 31.8, and lymphocytes 18.9.   On an unspecified date in Jan-2024, the patient recovered from the events.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 48-year-old patient was vaccinated with Flucelvax Quadrivalent and non-company co-suspects Engerix b, Vaqta and Boostrix on the same day. Flucelvax Quadrivalent and Vaqta were administered in the right arm (explicitly coded as 'Product administration error'). Within eight days following vaccination, the patient developed plenty of bruises on her arms and all over her body, and the patient felt so tired, she couldn't get up for work. Additionally, the patient also experienced haematocrit decreased, haemoglobin decreased, red blood cell count decreased and lymphocyte percentage decreased. Product administration error is assessed as not related as per company's conventions. Although causality is confounded by administration of co-suspect vaccines, it cannot be ruled out and is assessed as possible for contusion and fatigue, due to chronological plausibility. Causality for haematocrit decreased, haemoglobin decreased, red blood cell count decreased and lymphocyte percentage decreased is assessed as not related, due to biological implausibility.  Case correction (04-Mar-2024): After internal review of information, it was noted that the event Flucelvax Quadrivalent and Vaqta were administered on the same date, at the same anatomical location was inadvertently captured under LLT and PT Product administration error. The event was updated to LLT and PT Product use issue.; Reporter's Comments: A 48-year-old patient was vaccinated with Flucelvax Quadrivalent and non-company co-suspects Engerix b, Vaqta and Boostrix on the same day. Flucelvax Quadrivalent and Vaqta were administered in the right arm (explicitly coded as 'Product administration error'). Within eight days following vaccination, the patient developed plenty of bruises on her arms and all over her body, and the patient felt so tired, she couldn't get up for work. Additionally, the patient also experienced haematocrit decreased, haemoglobin decreased, red blood cell count decreased and lymphocyte percentage decreased. Product administration error is assessed as not related as per company's conventions. Although causality is confounded by administration of co-suspect vaccines, it cannot be ruled out and is assessed as possible for contusion and fatigue, due to chronological plausibility. Causality for haematocrit decreased, haemoglobin decreased, red blood cell count decreased and lymphocyte percentage decreased is assessed as not related, due to biological implausibility.