Age: 45.0
Sex: F
Vaccine: COVID19, FLUC3
Symptoms: Blood pressure fluctuation, Chest pain, Diarrhoea, Fatigue
Clinical narrative: Chest pains; Floating blood pressure; Diarrhea; Fatigue; This spontaneous case from the was received on 21-Oct-2021 from other non-healthcare professional and concerned a 45-year-old, female patient.  The patient's concurrent condition included low blood pressure. The patient's concomitant medications included Vitamin d (ergocalciferol) and Iron pills (ferrous sulfate), both used for unreported indication.  On 06-Oct-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 308444; expiration date: 25-Jun-2022.  On the same date, the patient was vaccinated with non-company co-suspect COVID-19 vaccine (brand not specified, dose, route of administration, indication and anatomical location: not reported). The batch number was not reported.  On 08-Oct-2021, two days after receiving Flucelvax Quadrivalent and non-company co-suspect Covid-19 vaccine, the patient experienced diarrhoea, fatigue and floating blood pressure. After a while she felt chest pains. Her doctor told her she should see a cardiologist. She wanted to know if the flu vaccine was a legit flu vaccine.   On an unspecified date in Oct-2021, the patient received treatment with Tramadol (tramadol hydrochloride) for the events.   At the time of initial reporting, the patient had not recovered from the event of 'chest pain' as the patient was still experiencing symptom.  The outcome of the all other events were not reported.  The reporter assessed the event of 'chest pain' related to Flucelvax Quadrivalent. It was reported that consumer stated she never experienced 'chest pain' after getting flu vaccines. This is the first time she got Flucelvax Quad. The reporter did not provide a causality assessment for the other events.  The case was assessed as non-serious.  Case updated on 26-Apr-2022: Correction made to information received on 21-Oct-2021: Regulatory authority was deleted from Intermediary field and Report Sent to Regulatory Authority by Reporter was changed from 'Yes' to 'Unk'. No changes in the narrative.  Company comment: A 45-year-old female patient experienced diarrhea, fatigue, chest pain and floating blood pressure 2 days after receiving Flucelvax Quadrivalent and non-company co-suspect product Covid-19 vaccines. The patient's past medical history included low blood pressure. Thus, causality for the event floating blood pressure is assessed as not related. Despite confounding by co-suspect Covid-19 vaccine, causality for all other events is assessed as possibly related based on plausible temporal relationship.; Sender's Comments: A 45-year-old female patient experienced diarrhea, fatigue, chest pain and floating blood pressure 2 days after receiving Flucelvax Quadrivalent and non-company co-suspect product Covid-19 vaccines. The patient's past medical history included low blood pressure. Thus, causality for the event floating blood pressure is assessed as not related. Despite confounding by co-suspect Covid-19 vaccine, causality for all other events is assessed as possibly related based on plausible temporal relationship.