Age: 69.0
Sex: F
Vaccine: COVID19, FLU4, COVID19, FLUA4
Symptoms: Immunisation, Off label use, Product use issue, Thinking abnormal
Clinical narrative: more or less in a coma; unable to eat; Felt tired; felt a "fog" on her brain; difficult to think; it got worse / condition had deteriorated rapidly; Booster; Other vaccine same date vaccine date 08Nov2021; Other vaccine same date vaccine date 08Nov2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 08Nov2021 14:30 (Lot number: 32030BD) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine inact sag 4v (FLUAD QUAD), administered in arm left, administration date 08Nov2021 (Lot number: 312879) as dose 1, single for immunisation. Relevant medical history included: "allergies: egg" (unspecified if ongoing), notes: known allergies: maybe eggs. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8730, Location of injection: Arm Right, Vaccine Administration Time: 13:15), administration date: 10Mar2021, when the patient was 68 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6199, Location of injection: Arm Right, Vaccine Administration Time: 13:15), administration date: 31Mar2021, when the patient was 68 years old, for COVID-19 immunization. The following information was reported: OFF LABEL USE (hospitalization, medically significant), PRODUCT USE ISSUE (hospitalization, medically significant) all with onset 08Nov2021, outcome "unknown" and all described as "Other vaccine same date vaccine date 08Nov2021"; IMMUNISATION (hospitalization, medically significant) with onset 08Nov2021 14:30, outcome "unknown", described as "Booster"; FATIGUE (hospitalization) with onset 09Nov2021 14:30, outcome "not recovered", described as "Felt tired"; FEELING ABNORMAL (hospitalization) with onset 09Nov2021 14:30, outcome "not recovered", described as "felt a "fog" on her brain"; THINKING ABNORMAL (hospitalization) with onset 09Nov2021 14:30, outcome "not recovered", described as "difficult to think"; CONDITION AGGRAVATED (hospitalization) with onset 09Nov2021 14:30, outcome "not recovered", described as "it got worse / condition had deteriorated rapidly"; COMA (hospitalization, medically significant) with onset 09Nov2021 14:30, outcome "not recovered", described as "more or less in a coma"; FEEDING DISORDER (hospitalization) with onset 09Nov2021 14:30, outcome "not recovered", described as "unable to eat". The patient was hospitalized for off label use, product use issue, immunisation, fatigue, feeling abnormal, thinking abnormal, condition aggravated (start date: 17Dec2021, hospitalization duration: 9 day(s)); for coma, feeding disorder (start date: 28Dec2021). The events "other vaccine same date vaccine date 08nov2021", "other vaccine same date vaccine date 08nov2021", "booster", "felt tired", "felt a "fog" on her brain", "difficult to think", "it got worse / condition had deteriorated rapidly", "more or less in a coma" and "unable to eat" were evaluated at the physician office visit and emergency room visit. It was reported the patient felt tired for 2 days then within the next 3 days felt a "fog" on her brain. She started to find it difficult to think. Over the next 2 weeks it got worse and the reporter took her to the emergency room (ER) on 27Nov2021. They could not find an answer; then they went to her family doctor and he did not have an answer. She was admitted to the hospital on 17Dec2021 as her condition had deteriorated in the previous 3 weeks. She was released to another hospital on 28Dec2021 where she was "more or less" in a coma unable to eat. The patient had not been tested for COVID post-vaccination. It was unknown if therapeutic measures were taken as a result of fatigue, feeling abnormal, thinking abnormal, condition aggravated, coma, feeding disorder..