Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Abnormal dreams, Confusional state, Derealisation, Fatigue
Clinical narrative: not behaving in the usual way; confusion; dissociation from the reality; her mom would get tired; she was dead, and can't afford a funeral; she was still upset about it; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 94-year-old female patient received BNT162b2 (BNT162B2), on 05May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 94 years for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: Apr2020 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 01), administration date: 05Feb2021, when the patient was 93-year-old, for COVID-19 Immunization; BNT162b2 (Dose: 02), administration date: 26Feb2021, when the patient was 93-year-old, for COVID-19 Immunization; Bnt162b2 (Dose: 03), for COVID-19 Immunization. The following information was reported: CONFUSIONAL STATE (non-serious) with onset 06May2022, outcome "unknown", described as "confusion"; DEREALISATION (non-serious) with onset 06May2022, outcome "unknown", described as "dissociation from the reality"; ABNORMAL BEHAVIOUR (non-serious) with onset 06May2022, outcome "unknown", described as "not behaving in the usual way"; FATIGUE (non-serious) with onset May2022, outcome "unknown", described as "her mom would get tired"; ABNORMAL DREAMS (non-serious) with onset May2022, outcome "unknown", described as "she was dead, and can't afford a funeral"; FEELING ABNORMAL (non-serious) with onset May2022, outcome "unknown", described as "she was still upset about it".   Additional information:Caller stated that her 94-year-old mother received the booster dose of the Pfizer-BioNTech COVID-19 Vaccine yesterday 05May2022. Today 06May2022 she noticed that her mother was not behaving in the usual way. Normally she is extremely active and involved with her community. However, this morning she had problem dressing. She also noticed confusion and dissociation from the reality. Caller wanted to know if those symptoms have been reported previously as AE. On Apr2020 she had COVID. Her test was asymptomatic, so she only had to isolate. She's been fine ever since. Before that she only had one dose, and she's received three vaccines after that. No reactions at all until now. Consumer was calling regarding her mom's reaction or what they think was a reaction after the second booster of COVID-19 vaccine. Caller said this was her mom's fourth dose altogether of the Pfizer COVID-19 vaccine, she had got her first two doses and then got her first and second booster doses. She said she wanted to know if it had been reported before, which her mother is 94 years old, so she is absolutely not sure if it could be a reaction to the vaccine or not. Primary Care Provider: Caller stated that this provider did not give her mom the injection, it was administered by a company that came to the facility her mom lives at. Caller stated her mom just got her second booster dose yesterday. She said she did not have her mother's vaccine card to provide NDC/LOT/EXP for any of the four doses. She stated she has the dates given for the first two vaccines. She stated the first vaccine was given 05Feb2021 and the second one was 26Feb2021. She stated it looks like she didn't write down the date of the third dose/first booster. Indication: Caller stated her mom got her Pfizer COVID-19 vaccines primarily because she is 94-year-old and lives in a community. She said her mother was also diagnosed positive with COVID in May2020, before there was any vaccines, and the facility had isolated her. She says her mother had no symptoms; she was non-symptomatic. She stated she asked for a second test for her mother to confirm, and they said their policy was for a positive test for them to be isolated, so they took her mom to a hotel where they had a wing isolated from everything else, which was very traumatic for her mom, that isolation. She stated her mom had tested positive in May2020, and her first vaccine dose was Feb2021. Caller stated that her mom said the only symptom she felt from the first time she was exposed to it, clarified to COVID-19 and not the vaccine, was that she slept most of the week. She stated her mom was positive for COVID May2020 after she was probably exposed in Apr2020 or Mar2020 by a caregiver. AE: Caller stated her mom's possible reaction is that she is 94 which sometimes she has word recall issues, but for the most part she is very much in the present. She stated when she called her mom this morning, she said she had a dream that she was not sure was a dream, which in it she was running around her apartment saying she couldn't afford to pay for her funeral at this time, she was dead, and can't afford a funeral. Caller stated the time her mom was telling her this was after she was up to the bathroom at 05:00AM so between then and 07:00AM, and when her caregiver arrived at 07:00AM she said her mom was very much confused and was feeling like she was dead and couldn't pay for her funeral. She stated this is not something that was recently discussed, and they can pay for her funeral, but they have never known her to disassociate from reality prior to this. She stated her mother knows current events, goes to eat meals with the other residents, is active, and is involved in all kinds of activities, so this is not typical for her. She stated when her mother's caregiver was there, she assured her she was fine, and told her she thought it would be best before she got washed up for the day if she had breakfast, and her caregiver made her oatmeal and she didn't go to the restaurant as usual, then ate half of that. Caller stated the caregiver made sure to let her know things about the present like what day it is, that they were in her apartment, and her mom was fine and realized perhaps it was a dream. Caller stated she talked to her mom at 11:30 and she was still upset about it and said never happened before. Caller asked was that a side effect of the vaccine, since in the past her mom would get tired, the usual side effects, which she has also had all four, and there was nothing out of ordinary. She says what happened this morning, as her daughter and healthcare POA she has to look at it and is thinking she should find out has this been reported, confusion, since it is unlike anything seen prior to this. Concomitant Medications: Caller stated that for the meds her mom takes, she takes none or nothing psychotropic or currently new, what she takes has been taken for a period of time. Caller stated she just wanted to see if confusion has been reported before. She stated she was going to call her mom again after this since she usually naps in afternoon and her caregiver will be by in the afternoon again because she needs help getting dressed and bathing. Caller clarified that is normal for her, and that otherwise her mom is independent, she has bad rotator cuffs and that is the primary reason she needs help, they aren't going to do surgery at her age.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.