Age: 70.0
Sex: F
Vaccine: COVID19, FLUX, COVID19, FLUX
Symptoms: Intraocular pressure test, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: not being able to pronounce words correctly; Has brain fog; Caller also provided that she had went blind in one eye after receiving the third dose of the Pfizer Covid-19 vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 25Sep2021 as dose 3 (booster), single (Lot number: 30135BA) at the age of 70 years, in arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 01, lot: EL3246 , NDC: Unknown, Expiration: Unknown , Route of administration: Arm), administration date: 15Jan2021, when the patient was 70-year-old, for COVID-19 Immunization; BNT162b2 (Dose: 02, lot: EL9264, NDC: Unknown, Expiration: Unknown , Route of administration: Arm), administration date: 03Feb2021, when the patient was 70-year-old, for COVID-19 Immunization. The following information was reported: BLINDNESS (medically significant) with onset 04Oct2021, outcome "recovered", described as "Caller also provided that she had went blind in one eye after receiving the third dose of the Pfizer Covid-19 vaccine."; FEELING ABNORMAL (non-serious) with onset 12May2022, outcome "unknown", described as "Has brain fog"; SPEECH DISORDER (non-serious), outcome "unknown", described as "not being able to pronounce words correctly". The patient underwent the following laboratory tests and procedures: Intraocular pressure test: (unspecified date) 44, notes: eye pressure went up to 44; SARS-CoV-2 test: (12May2022) Positive.  Clinical Course: Request Name: REQ-794263, REQ-794265, REQ-794229, REQ-794270, REQ-794272, REQ-794271  for the Product COMIRNATY (COVID 19 Vaccine, mRNA), Patient asked if the vaccine that is released now is protective against the omicron variant. Patient asked if the omicron targeted variant vaccine will be released in September. Patient received three doses of the Pfizer Covid-19 vaccine, however has tested positive for the Covid virus. Patient received Bebtelovimab through IV on Friday, 13May2022. Patient wants to receive the fourth dose of the Pfizer Covid-19 vaccine, and is asking if she is able to due to receiving Bebtelovimab. Patient states she is supposed to receive the fourth dose on 04Jun2022 and would like to get the vaccine prior to leaving town. Patient stated it has been 8 months since her third dose and she is very concerned to travel and visit relatives who have underlying conditions. Patient states if she does not receive the vaccine on 04Jun2022, then she will not be back in town until the end of July to receive the vaccine. Patient described that she is having brain fog and experiences episodes of not being able to pronounce words correctly. Patient stated she will say, "wah from web uh from (Name Withheld) and try to put them together in place of a word, that is the kind of thing that is happening with me." Patient stated that she believes she came down with Covid after being at an outdoor event in (City Name Withheld) at an athletic event which was consumed of a younger population. Patient stated everyone was supposed to be vaccinated, however the camper and their son next to her was not vaccinated. Patient also provided that she had went blind in one eye after receiving the third dose of the Pfizer Covid-19 vaccine. Patient also asked if you can receive the Pfizer Covid-19 vaccine and the flu vaccine at the same time. Patient stated that she was told by a pharmacist that she could receive as many vaccines as she wanted and witness them administer 8 vaccines to another patient. Patient asked, "how many months after the fourth dose can she get another at this time. Patient stated that she has consulted with her doctor, nurses, (Name Withheld) and "no body can give me a definitive answer." Patient stated, "she still don't know the answer to my question. Patient stated that she was  going to have to go on faith and decide what to do. This was really difficult." Pfizer Covid 19 Vaccine  Date and Time of Start of Drug: 15Jan2021, Batch/lot number: 30135BA, Dosage text was Arm, doesn't remember which arm, third dose. Indication as Reported by the Primary Source was because of age and was time to receive. This report related to a study or programme, Selected Report Type: Initial. Patient was also the reporter. No other Conditions and other Products. Investigations were Yes. The Patient completed three doses of the Pfizer Covid 19 Vaccine and has Covid. Since getting Covid, Patient received a treatment medication, Bebtelovimab. Patient will be receiving the fourth dose Pfizer Covid 19 Vaccine and would like to know if there will be a reaction with Bebtelovimab and the fourth dose Pfizer Covid 19 Vaccine the Patient would like to receive. Patient confirms details provided by the transfer agent. Patient states Bebtelovimab is a monoclonal for the Omicron. Patient is supposed to receive the fourth dose Pfizer Covid 19 Vaccine. Patient says on the (Website Name Withheld), states Bebtelovimab possibly could interfere with body's own ability to fight off future infection as far as CoV2, may reduce body's immune system response to Vaccine for SARS CoV2. If Bebtelovimab stays in the body for 60 days, during the 60 days probably not recommended to receive booster dose of the Pfizer Covid 19 Vaccine because might interfere with the booster dose. Patient is trying to find out if the Bebtelovimab will interfere with the fourth Pfizer Covid 19 Vaccine the patient would like to receive? Also, the patient was blind in one eye after receiving third dose Pfizer Covid 19 Vaccine. HCP: Patient does not want to provide name, address, telephone number or email because has not asked permission. Has brain fog: Patient has brain fog right now. Patient knew the date and now can't remember, so weird. Patient is really having brain fog after getting Covid. Was blind in one eye after receiving third dose: A few days after receiving third dose Pfizer Covid 19 Vaccine, blind in one eye began. Patient doesn't know if related to the third dose Pfizer Covid 19 Vaccine. The Patient also had the flu shot within 2 days of receiving the third dose Pfizer Covid Vaccine. NDC/lot/expiration of flu vaccine not provided. Patient was also in a traumatic situation and could have been stress from this experience. Patient clarifies the going blind in one eye began on 04Oct2021. The Patient had bled internally in the eye where couldn't see and dried blood was found. Patient had a big work up with lots of specialists. About a week later being blind in one eye was gone. Think what may have happened, nobody knows, just speculation, if blood there would have blocked eye breathing liquid, fluids fill up and eye pressure went up to 44. Once that was gone, being blind in one eye dissipated about a week later. Patient states Patient recovered completely from being blind in one eye. Tested positive for Covid: Took the covid test on 12May2022 and received result on 13May2022. Bebtelovimab: NDC/lot/expiration: Unknown, given IV on 13May2022. According to (Name Withheld), Bebtelovimab stays in body for 60 days but half of it is gone in 12 days. Patient has brain fog. Has brain fog: Started feeling badly on Thursday, 12May2022 and Friday, 13May2022 got worse. Its just like dumb things like want to go get a cup from cabinet but walk in that direction and open fridge. Patient's husband said noticed. Patient's husband said for patient not to make any decisions about anything. Patient has to travel outside of the country and has to apply with Covid information and husband said not to do it now because patient was not thinking straight, husbands notices more than her. Yes there a product complaint to report. Description of Product Complaint: tested positive for Covid after receiving three doses of the Pfizer Covid 19 Vaccine. Product strength and count size dispensed was N/A. Is a sample of the product available to be returned, if requested (Y/N) was N/A. Packaging sealed and intact was N/A. PC is not suspect product, identified while completing the report. Description of complaint: Bebtelovimab possibly could interfere with body's own ability to fight off future infection as far as CoV2, may reduce body's immune system response to Vaccine for SARS CoV2. Caller questioning if Bebtelovimab would cause interference with Pfizer Covid 19 Vaccine. Product strength and count size dispensed were Not provided. Additional lot numbers were Unknown. Is a sample of the product available to be returned, if requested (Y/N) was N/A, given IV. Packaging sealed and intact was N/A  No follow-up attempts are possible. No further information is expected.