Sex: F
Vaccine: COVID19
Symptoms: Dementia
Clinical narrative: Bad Reaction Dementia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEMENTIA (medically significant), outcome "unknown", described as "Bad Reaction Dementia".  Clinical course: the reporter stated, hello, I was not sure where to send this form. I discovered this on 03Dec and had to confirm the name and phone number to be able to complete the form today. I spoke with (person) this evening to collect some additional details and told he she would be contacted by a Pfizer representative. She will be prepared to provide her doctor's contact information. Let me know if you need anything else from me. Pfizer Product Safety Information Report Form: Date: 03Dec2022. Note: Tell the reporter that Pfizer may contact them to follow up. Told on 07Dec2022 during phone call. Covid-19 vaccine reaction Dementia. Was the product used by the patient: Yes Description of the event, comment or concern as provided by the reporter: After vaccine kept repeating things husband was concentrated, possible dementia (name withheld) said has improved since the vaccine reaction but still needs to get back to where she was before. Any other relevant information: (name) will provide doctor phone number so Pfizer can collect from Doctor. Who is completing the Product Safety Information form. Upon follow-up received on 08Dec2022, this is a spontaneous follow-up report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included: Updated information included: Reporter information/Patient information (state) added. Event occurrence country updated. Drug obtain country and Facility details (state and country) updated. Additional information: Query: Dear Colleague, Thank you for providing information related to an adverse event received from a consumer reporter, (name withheld), on 03Dec2022. Upon review of the form I noticed that the reporter phone number appears to have a (state name withheld), area code and would just like to confirm whether this is a country based event/reporter? Many thanks in advance for your assistance in this matter. Response: This is country based. I work remotely in (city and state name withheld) and (name withheld) lives in (state name withheld) and received vaccine in (withheld). Follow-up (12Dec2022): This is a spontaneous follow-up report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included: Updated information included: Reporter information slider #03 added. Additional information: Query: Thanks for sending this AE information to safety. Since the Pfizer awareness date was captured as 03Dec2022 and not reported until 08Dec2022, you have submitted this report outside of the 24 hour compliance timelines. Would you kindly confirm your awareness date and if delayed please provide a reason for the delay in forwarding to safety. Lastly, kindly confirm you have completed AE reporting training and are aware of the timelines for reporting. Response: Hello, Yes I have AE training and was actually very stressed for days. I reported the accurate date. I was at a event among elderly woman 70s and 60s on Saturday night. I thought the person's name was (name withheld) who told me this. I only had her phone number and told her I had to report what she told me because of Pfizer procedure. That night I knew I could not complete the from with the wrong name and if you called her she would have thought was was a wrong number. I did not go online late Saturday evening to start the form. Yes I did have information on Saturday and did not tell Pfizer and complete this form. Sunday morning my son called me. My oldest grandchild 4 was in the hospital, and my 4-month grandchild had just been released from the hospital with (Hospital name withheld). On Sunday I was talking care of the 3rd grandchild for my son and did not report. On Monday I contacted the person who invited me, (name withheld) to find out the lady's correct name so I could call this person who was 79 and has some dementia. The lady is in her mid 80s did not reply to my call. Truth I was very much focused on my own family and my grandchildren. I knew you would all be contacting me on this. I called contact, as soon as I received her name from contact. I had to refresh her memory and told her Pfizer would be contacting her that same day I sent the form. I am sorry for not reporting on Saturday evening. Please let me know next steps for non-compliance. The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.