Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Confusional state, Emphysema, Feeling abnormal, Hallucination
Clinical narrative: Nothin taste good; COPD; Emphysema; Little confused at time so to speak slowly; Little confused at time so to speak slowly; Hallucinations; She was absolutely miserable/nothing sounds good, overall not feeling good; This is a spontaneous report from a contactable consumer based on information received by Pfizer from Sanofi (manufacturer control number: 2021SA002076).  A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE (TOZINAMERAN), Solution for injection. Lot number: unknown), dose 1 via an unspecified route of administration on 08Jun2021 (at the age of 73-years-old) as dose 1, single for COVID-19 immunization and dupilumab (DUPIXENT, Batch/Lot number: unknown) at 600 mg, 1x/day, subcutaneous from 2019 and ongoing, at 300 mg QOW for severe persistent asthma. Medical history included severe persistent asthma. In 2019 (unknown date), the patient started taking Dupilumab 300 mg solution for injection at a dose of 600 mg es loading dose followed by 300 mg every other week via subcutaneous route with an unknown expiry date and batch number) delivered via Dupilumab prefilled syringe. Reason for use: severe persistent asthma (product use issue latency: Same day Information on batch number was requested. It was not the first time patient used the product. Past medical history, medical treatments and family history were not provided. Concomitant medications included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY) and nebulizer (unspecified) that she uses 3 to 4 times a day.   On an unspecified date patient experienced hallucinations COPD (Chronic obstructive pulmonary disease) emphysema, asked when going to start seeing improvement, nothing taste good, does not feel good, nothing sounds good, overall not feeling good. She used 800 mg as loading dose followed by 300 mg every other week used for severe persistent Asthma. Took an Injection at the beginning of this month a day early scheduled dose was due on 02Jun2021 but took on 01 Jun2021. She was little confused at times so to speak slowly and she already had her first covid-19 vaccine 3 weeks ago and she was absolutely miserable, while she was treated with Duplumab (Duplent) delivered via duplurnab prefilled syringe Tozinameran Pfizer/BioNTech COVID-19 vaccina) and 2 medications (unspecified).  The patient reported that she was on 2 medications unspecified that were giving her (unknown onset and latency) hallucinations (hallucination), COPD (Chronic obstructive pulmonary disease) and emphysema. The medical doctor was aware and she was no longer on the medications. When she was asked if she was using other medications for her asthma, consumer stated that none she can think of and said that she was taking a lot of medications. Also she had a question on when she was going to start seeing improvement (drug ineffective: unknown onset and latency and the nurse answered her question during the call. The patient said that she received paperwork involving a reaction to the Dupixent, but she stated that Dupixent did not have anything to do with this at all. She stated that the adverse event was in regard to hallucinations with Ed A Hist. She called her doctor and told her that she was seeing people in her house and experiencing hallucinations and her doctor told her to stop taking Ed A Hist and the hallucinations disappeared. She stated that she was aware of two other people that had the same reaction to ED A Hist and her son had the exact same reaction to it as well. She stated that she was doing great right now on Dupixent.  Last Tuesday 08Jun2021.consumer took the Pfizer COVID Vaccine and did not feel good, nothing taste good (taste disorder, onset date: Jun-2021. Latency: 2 years approximately nothing sounds good, overall not feeling good (feeling abnormal onset date Jun2021, latency 2 years approximately). It was unknown from the nurse if the consumer takes Dupilumab as an add on medication for her asthma. No additional information was available at the time of the report. Latency approximately 1 year and few months after Dupilumab and unknown after tozinameran). On an unknown date the patient was little confused at times so to speak slowly confusional state) (slow speech) unknown latency Reportedly patient took her last Dupilumab dose on 18Jun2021 and would be taking the next Dupilumab dose 30Jun2021 and her COVID vaccine was scheduled for 02Jul2021. The Patient wanted to be sure if this was going to be okay. The patient stated that she already had her first COVD 19 vaccine 3 weeks ago and she was absolutely miserable. She stated that was the Pfizer COVID-19 vaccine and she said she had to get another one, she would be going to die. Seriousness criteria: Medically significant for hallucination. The outcome of the events feeling abnormal and taste disorder were not recovered while other events were unknown.  Reporter causality: Reported for dupilumab for all events Related to hallucinations, COPD (chronic obstructive pulmonary disease) and emphysema and not related to drug ineffective and product use issue for other 2 medications (co-suspects).  Company causality: Not reportable for all events.