Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID Virus; COVID Virus; 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 66-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Feb2021 as dose 1, single (Lot number: EL9266, Expiration Date: 31May2021), in left arm, on 10Mar2021 as dose 2, single (Lot number: EN6205, Expiration Date: 30Jun2021), in left arm and on 08Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing), notes: COPD Diagnosed maybe 5-10 years ago.; "Seasonal Allergies and allergic to cats, dogs and milk." (unspecified if ongoing), notes: Seasonal Allergies and allergic to cats, dogs and milk.; "Seasonal Allergies and allergic to cats, dogs and milk." (unspecified if ongoing), notes: Allergies diagnosed as a child.  She was born allergic to milk.; "liver problems" (unspecified if ongoing), notes: have liver problems and COPD. There were no concomitant medications. Vaccination history included: Flu shot (Dose number: Unknown, MANUFACTURER UNKNOWN), for Immunization, reaction(s): "came down with a really bad case of the flu.". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovered" and all described as "COVID Virus". The event "covid virus" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: Feeling sick like she had a cold and did a home test swab and it came back positive really fast. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient had been boosted with Pfizer 1 and 2 and a booster. Patient can't take Paxlovid because have liver problems and COPD. Patient got COVID after that and got the monoclonal antibodies. Patient was trying to get BA booster now and when went to the hospital to get it there was a list of questions and one of them was asking Patient to say "I have never received passive whatever for treatment of COVID" but patient did because had the monoclonal antibodies. Patient needed the booster. This virus is new and doctor's play a guessing game with this. Patient was on the line regarding Pfizer COVID 19 vaccine adult formulation and unsure if purple or grey cap. Received doses 1, 2 and a booster and then contracted COVID in May 2022. Patient did mention that her husband received the vaccine as well and then agent inadvertently disconnected before providing any additional details about husband. Patient stated they did not have any adverse reactions to the booster. Withheld said that people that took the Pfizer vaccines and contracted COVID afterwards is the reason she transferred her. Her husband also contracted COVID first and then she got it. He also received 3 doses of the Pfizer COVID vaccine. Patient said her husband took Paxlovid. She cannot take it, so she took Monoclonal antibodies. Patient took everything into her own hands and decided to go somewhere where they were giving the Monoclonal antibody. A week later than her husband got COVID virus, she got it. 3rd dose given on 08Sep2021, Lot and expiration are unknown. They did not put on card. She went to a different facility for this one. Boster was given at different facility. That was given at Withheld. The county they live in in Withheld, it was a county Hospital. Additional vaccines administered on same date of the pfizer suspect administered on same date with the pfizer vaccine considered as suspect was reported as none. It was reported that onset of AE COVID Virus - in the morning. Feeling sick like she had a cold and did a home test swab, and it came back positive really fast. She has COPD, but has a liver disease and could not go for the Paxlovid. She read up on the Paxlovid and cannot swallow pills. You can't crush it, so she could not swallow those gigantic pills. She just called where they were giving monoclonal antibodies. Patient had COPD, liver disease, and could not swallow pills. They put her in the emergency room only because she had COVID at the time and instead of her being with the general population they brought her to ER so she could be in her own room not to infect anyone else. She confirmed she was not admitted. Regarding Physician Office visit, she just went to the hospital to get the Monoclonal antibody. She received it on an outpatient basis. Patient did not have any prior vaccinations (within 4 weeks) within four weeks prior to the first administration date of the suspect vaccine. AE(s) following prior vaccinations: A really long time ago in the 1970's they had a case of swine flu and she went and got a flu shot for it and came down with a really bad case of the flu. After that she would not get the flu shots ever again. No manufacturer, lot or expiration for the one she got. She said it may have been a live virus. Family medical history relevant to AE(s) and relevant tests were reported as none. Patient needs to go for the new booster B4BA5, when she went to website it asked her if you have been treated with Monoclonal antibodies. She wanted to know if she could get it. Why is that question even on there and Pfizer can't help her. Go see your medical Doctor, but if Pfizer doesn't know, then how will her medical doctor. She wants to know why is that a question. It makes you swear you have never received them and doesn't know what it has to do to the booster.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201152062 same reporter/drug/event, different pt;