Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, Investigation, SARS-CoV-2 test
Clinical narrative: again had COVID-19 now; again had COVID-19 now; She had to switch to Moderna vaccines for the boosters; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 09Jan2021 at 16:30 as dose 1, single (Lot number: EL3247), in right arm and on 09Feb2021 at 17:15 as dose 2, single (Lot number: EM9810) at the age of 71 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Dec2021 at 15:40 as dose 3 (booster), single (Lot number: 939903), in right arm, on 01Jun2022 at 17:20 as dose 4 (booster), single (Lot number: 054222A), in right arm, on 22Oct2022 at 12:05 as dose 5 (booster), single (Lot number: 0171422A), in right arm and on 23May2023 at 12:00 as dose 6 (booster), single (Lot number: A57167B), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sensitive to drugs" (unspecified if ongoing), notes: Known allergies: sensitive to drugs; "cholesterol" (unspecified if ongoing); "Afib" (unspecified if ongoing), notes: Also has heart A fib problem., She talked to her cardiologist when medication came in they told her to take half of the Eliquis prescribed and her cholesterol medication they have her on./She does have an A-fib problem and is on blood thinners. The patient's concomitant medications were not reported. Past drug history included: Benadryl, reaction(s): "allergic to Benadryl", notes: She is allergic to Benadryl. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Dec2021, outcome "unknown", described as "She had to switch to Moderna vaccines for the boosters"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Jul2023, outcome "not recovered" and all described as "again had COVID-19 now". The patient underwent the following laboratory tests and procedures: tested for flu: (unspecified date) unknown results; (unspecified date) unknown results; SARS-CoV-2 test: (02Jul2023) Positive, notes: on 02Jan2023 a NP called and told her she was positive for Covid; (12Jul2023) Positive, notes: 12Jul2023 tested positive for Covid again; (unspecified date) Positive, notes: Got herself tested on a home kit and she was COVID-19 positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: She got the prescription today because of Covid however the caller is concerned because she had 2 previous Covid vaccines from Pfizer. Calling to make sure she can take Paxlovid because of previous reactions with vaccines. States that Moderna was less invasive and less problematic. She is sensitive to drugs. Has had Covid twice. Beginning of January she was very sick. Had the 2 main vaccines of Pfizer and like 4 boosters of Moderna, the last on 23May2023. She went away for 8 days and felt bad Sunday. Yesterday found out she has Covid again. Doesn't get this. Wears double mask in. She is allergic to Benadryl, her heart starts palpitating. PA said may have had allergic reaction to Pfizer. She didn't think that. Was told if her throat begins to close up go to ER. She didn't have to do that, she was fine. Knew there were future boosters and talked about Moderna. Much better. Had some flu like headache for 4 days but survived it. COVID-19 Vaccines gave her a fever. With all of the COVID-19 Vaccines she felt very uncomfortable for 3-4 days afterwards. Doesn't understand why this has happened to her. Was calling you because she just got the Paxlovid delivered. She has COVID-19 again. Had COVID-19 first in Jan2023. Doesn't understand. Had the boosters and double masks. She is very upset that she's been doing this and she's not getting protected. First started having COVID-19 symptoms on 29Dec2022, went to her PCP on 30Dec2022. Had to wait over the weekend and on 02Jan2023 was told she had COVID-19. She was cleared for strep and was cleared for flu, but she was very sick. She was there 15 days. Had upper respiratory and was given antibiotics for that. She's really upset. Was away for 8 days and got back Saturday and then on Sunday she came down with the same kind of throat problem and thought it was strep. Got herself tested on a home kit and she was COVID-19 positive. States this is ridiculous. Her PCP suggested Paxlovid and she's concerned about it. She does have an A-fib problem and is on blood thinners. She doesn't want more complications in her life. Paxlovid: Just got it today, has not consumed it yet. She would start it tonight. NDC: 0069-0345-30 LOT: GJ7122 EXP: Aug2023 Can she give the COVID-19 virus to her cat? States she's had 8 days of separation and anxiety. Referred caller to her cat's veterinarian on whether or not COVID-19 can be transmitted to cats. She is apprehensive to take Paxlovid because she has this heart problem and doesn't want more problems. She is going to have to think about if she is going to take the Paxlovid.  Based on investigation of PFIZER-BIONTECH COVID-19 VACCINE result conclusion: The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL3247 and EM9810, fill lot EL3230 and EM9806, and the formulated drug product lot EL3223 and EM9808. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300250670 same patient/event, different vaccine dose;