Age: 69.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: General physical health deterioration, Loss of consciousness, Memory impairment, Respiratory rate decreased
Clinical narrative: Basically unconscious; Very slow breathing; Memory started to deteriorate; Condition continued to deteriorate / was deteriorating rapidly; This spontaneous case was retrieved on 20-Jan-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2000413-1), reported by other non-healthcare professional and concerned a 69-year-old, female patient.  The patient's concurrent condition included allergy to eggs (also reported as 'maybe eggs'). The patient's concomitant medications were not reported.  On 08-Nov-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: reported as 'one', route of administration: intramuscular (IM), anatomical location: reported as 'in 2 different arms' and indication: not reported. The batch number reported was 312879.   On the same day, the patient was vaccinated with non-company co-suspect Pfizer BioNTech COVID-19 vaccine (tozinameran; dose: reported as 'third', route of administration: IM, anatomical location: reported as 'in 2 different arms' and indication: not reported. The batch number reported was 32030BD.  On 10-Nov-2021, two days after receiving Fluad Quadrivalent and Pfizer BioNTech COVID-19 vaccine, the patient's memory started to deteriorate.  On 27-Nov-2021, the patient was admitted to emergency room (ER) where they did a battery of test and could find nothing wrong.  On an unspecified date in 2021, over the next three weeks, as reported, the patient's condition continued to deteriorate.  On 17-Dec-2021, the patient was admitted to the hospital. Again they could find nothing wrong and she was deteriorating rapidly.   On 27-Dec-2021, the patient was discharged from hospitala and moved to hospice care.  On an unspecified date, the patient was basically unconscious with very slow breathing.  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 assessed as serious due to seriousness criteria of life-threatening condition, disability and hospitalisation. Additionally, the event of 'unconscious' was considered to be medically significant by Physician within regulatory authority.  Company comment: A 69-year-old patient experienced memory impairment on the same day after receiving the suspect product Fluad Quadrivalent and non-company co-suspect Pfizer BioNTech COVID-19 vaccine. The patient also developed loss of consciousness, general physical health deterioration, and decreased respiratory rate an unknown amount of time after vaccination. Advance age of patient contributed to the development of the events memory impairment and general physical health deterioration. Based on biological implausibility and confounding factor, causality for the event memory impairment is assessed as not related. For the rest of the events causality is unassessable, due to unclear time relationship.; Sender's Comments: A 69-year-old patient experienced memory impairment on the same day after receiving the suspect product Fluad Quadrivalent and non-company co-suspect Pfizer BioNTech COVID-19 vaccine. The patient also developed loss of consciousness, general physical health deterioration, and decreased respiratory rate an unknown amount of time after vaccination. Advance age of patient contributed to the development of the events memory impairment and general physical health deterioration. Based on biological implausibility and confounding factor, causality for the event memory impairment is assessed as not related. For the rest of the events causality is unassessable, due to unclear time relationship.