Age: 38.0
Sex: F
Vaccine: COVID19, FLUC3, TDAP
Symptoms: Blood iron, Blood iron decreased, Computerised tomogram, Electrocardiogram, Full blood count
Clinical narrative: Blood clot in lower right lung; Low iron levels; Tachycardia; Low hemoglobin; This spontaneous case was retrieved on 09-Jan-2024 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2720660-1), reported by other healthcare professional and concerned a 38-year-old, female patient.    The patient's concurrent conditions included fibroids, seasonal allergies, and drug allergies to Yaz and Claritin. The patient's concomitant medication included Zyrtec (cetirizine hydrochloride), used for unreported indication.  It was reported that on 25-Sep-2023, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; route of administration: intramuscular (IM); anatomical location: left arm (LA); dose and indication: not reported). The batch number reported was 370650. The reported batch number was identified by Seqirus to be linked to the suspect product Flucelvax Quadrivalent (influenza vaccine inact sag 4v) instead of the reported suspect product Fluad Quadrivalent. Based on the reported batch number, the suspect product was changed to Flucelvax Quadrivalent.  On the same date, the patient was vaccinated with a non-company, co-suspects Pfizer BioNTech COVID-19 vaccine (tozinameran; dose: reported as '3'; route of administration: intramuscular (IM); anatomical location: right arm (RA); indication: not reported; batch number: HG4628), and Boostrix (diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid; route of administration: intramuscular (IM); anatomical location: right arm (RA); dose and indication: not reported; batch number: E3594).  On 19-Oct-2023, 24 days after receiving Flucelvax Quadrivalent and a non-company, co-suspects Pfizer BioNTech COVID-19 vaccine and Boostrix, the patient experienced tachycardia for several weeks and hemoglobin was low.The patient's treatment included blood thinners.  On 20-Nov-2023, a complete blood count (CBC) and metabolic panel test confirmed low iron.  On 26-Nov-2023, an electrocardiogram (ECG), iron level, and X-ray tests were in the normal range. A computerized tomography (CT) scan identified a blood clot in the lower right lung.  On an unspecified date in 2023, the patient was admitted to a hospital. After three days, the patient was discharged from a hospital.  At the time of initial reporting, the patient had not recovered from the events.    The reporter did not provide a causality assessment.  All events were considered as serious due to the seriousness criteria of hospitalization and life-threatening. Additionally, the event of 'pulmonary thrombosis' was considered to be medically significant by Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 38-year-old patient experienced tachycardia and developed low haemoglobin 24 days after receiving the suspect product Flucelvax Quadrivalent and a non-company, co-suspect vaccines Pfizer BioNTech COVID-19 vaccine and Boostrix. A complete blood count and metabolic panel test was conducted one month and 26 days after vaccination, revealing a low iron level. The patient also underwent computerized tomography scan, one month and 32 days after vaccination, which detected a blood clot in the lower right lung. Based on biological and chronological implausibility, causal role of the suspect vaccine is assessed as not related.; Sender's Comments: A 38-year-old patient experienced tachycardia and developed low haemoglobin 24 days after receiving the suspect product Flucelvax Quadrivalent and a non-company, co-suspect vaccines Pfizer BioNTech COVID-19 vaccine and Boostrix. A complete blood count and metabolic panel test was conducted one month and 26 days after vaccination, revealing a low iron level. The patient also underwent computerized tomography scan, one month and 32 days after vaccination, which detected a blood clot in the lower right lung. Based on biological and chronological implausibility, causal role of the suspect vaccine is assessed as not related.