Sex: U
Vaccine: COVID19, COVID19, COVID19, FLUC3
Symptoms: Asthenia, Body temperature, Decreased appetite, Fatigue, Headache
Clinical narrative: Flu; Sinus literally killing me; Horrible body ache; Have no energy; Appetite have been exhausted/no appetite; Have been so sick; Threw up few times; Excruciating Headache; Nauseous; Fever 102.5/100; Not feeling great; Have been exhausted; Hives; This spontaneous case was received on 26-Oct-2023 from other non-healthcare professional (consumer) via Pfizer (reference number: US-PFIZER-INC-202300316345) and concerned a female patient of an unspecified age and gender.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; route of administration, anatomical location, dose, and indication: not reported). The batch number reported was 942309 and expiry date reported was Jun-2023. As reported, the patient did not receive flu shot in 2023.  On an unspecified date, the patient was vaccinated with first dose of non-company, co-suspect COVID-19 vaccine (reported as Moderna unspecified vaccine, active ingredients not specified; dose, anatomical location, route of administration and indication: not reported). The batch number reported was 027A2119.  On an unspecified date, the patient was vaccinated with second dose of non-company, co-suspect COVID-19 vaccine (reported as Moderna unspecified vaccine, active ingredients not specified; dose, anatomical location, route of administration and indication: not reported). The batch number reported was 064H21A.  On an unspecified date, the patient was vaccinated with third dose of non-company, co-suspect COVID-19 vaccine (reported as Moderna unspecified vaccine, active ingredients not specified; dose, anatomical location, route of administration and indication: not reported). The batch number was not reported.  On an unspecified date, the patient was vaccinated with non-company, co-suspect COVID-19 vaccine (reported as Pfizer COVID-19 vaccine, active ingredients not specified; dose, anatomical location, route of administration and indication: not reported. The batch number reported was FN2908 and expiry date reported was Sep-2022.  On an unspecified date, the patient was vaccinated with non-company, co-suspect COVID-19 vaccine (reported as Pfizer COVID-19 bivalent vaccine, active ingredients not specified; dose, anatomical location, route of administration and indication: not reported. The batch number reported was GJ3274 and expiry date reported was May-2023.  On 30-Sep-2023 at about 11.20 am, reported as on Saturday, the patient was vaccinated with non-company, co-suspect Comirnaty vaccine (tozinameran; anatomical location: left deltoid, dose: 0.3 ml, route of administration and indication: not reported). The batch number reported was HG4628 and expiry date reported was Nov-2023.  On an unspecified date, an unknown amount of time after receiving Flucelvax Quadrivalent vaccine, and non-company co-suspect unspecified Moderna COVID-19 vaccine, the patient had rough time and experienced flu for two days.    On 30-Sep-2023, an unknown amount of time after receiving Flucelvax Quadrivalent and non-company co-suspect unspecified Moderna COVID-19 vaccines, non-company co-suspect unspecified Pfizer and Pfizer bivalent COVID-19 vaccine and Comirnaty vaccine, the patient was felling so sick. The patient was nauseous and was not feeling great. The patient threw up few times, had no appetite, and have been exhausted. It was reported that sinus was literally killing the patient. At three o'clock, the patient experienced excruciating headache. At six o'clock patient experienced body ache and at eight o'clock terrible fever of 102.5.   On an unspecified date in 2023, reported as 24 hours later, the patient woke up with hives. The patient still had headache. Fever was improved to 100. Patient was not throwing up, and sinus was better when patient was up right. The patient took Tylenol (paracetamol) at dose of 325 mg three times a day.   On an unspecified date in 2023, reported as this morning, the patient took one Tylenol 325 mg.  At the time of initial reporting, the patient was recovering from event fever.  The outcome of all events flu, sinus disorder, general body pain, loss of energy, appetite lost, sickness, vomiting, headache, hives, nauseous, feeling unwell and exhaustion was not reported.  The reporter did not provide a causality assessment.  The event flu was considered to be medically significant by Physician within Seqiruss.  Company comment: A patient of unspecified age experienced influenza an unknown amount of time after receiving the suspect product Flucelvax Quadrivalent vaccine, and non-company co-suspect unspecified Moderna COVID-19 vaccine. The patient also developed sinus disorder, general body pain, asthenia, decreased appetite, illness, vomiting, headache, urticaria, nausea, fever, malaise, and fatigue at least approximately nine months after vaccination. The patient's medical history, concomitant drugs, and diagnostic findings were not provided. Due to lack of information and unclear temporal relationship, causality for the event influenza is unassessable. For the rest of the events causality is assessed as not related, based on implausible temporal relationship.; Sender's Comments: A patient of unspecified age experienced influenza an unknown amount of time after receiving the suspect product Flucelvax Quadrivalent vaccine, and non-company co-suspect unspecified Moderna COVID-19 vaccine. The patient also developed sinus disorder, general body pain, asthenia, decreased appetite, illness, vomiting, headache, urticaria, nausea, fever, malaise, and fatigue at least approximately nine months after vaccination. The patient's medical history, concomitant drugs, and diagnostic findings were not provided. Due to lack of information and unclear temporal relationship, causality for the event influenza is unassessable. For the rest of the events causality is assessed as not related, based on implausible temporal relationship.