Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Haemoglobin, Investigation, Liver function test, SARS-CoV-2 antibody test
Clinical narrative: Positive for COVID-19 on a home test three days after receiving the Pfizer COVID-19 booster; Positive for COVID-19 on a home test three days after receiving the Pfizer COVID-19 booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team and product quality group, Program ID:  The reporter is the patient.  A 54-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Jan2023 at 11:00 as dose 3 (booster), single (Lot number: GL0447) at the age of 54 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Aug2022 at 10:30 as dose 1, single (Lot number: FN2908), in left arm and on 24Aug2022 at 11:15 as dose 2, single (Lot number: FP7138), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: Been on medication for three years; "Right ankle injury Had to have surgery" (unspecified if ongoing), notes: Either 2017 or 2018, Resulted in permanent nerve damage; "Right ankle injury Had to have surgery" (unspecified if ongoing), notes: Either 2017 or 2018, Resulted in permanent nerve damage; "Resulted in permanent nerve damage" (unspecified if ongoing), notes: Right ankle injury Had to have surgery either 2017 or 2018; "COVID-19", start date: 15Jan2021 (unspecified if ongoing); "COVID-19", start date: 17Jan2022 (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Jan2023, outcome "recovered", and all described as "Positive for COVID-19 on a home test three days after receiving the Pfizer COVID-19 booster". The event "positive for covid-19 on a home test three days after receiving the Pfizer covid-19 booster" required physician office visit. The patient underwent the following laboratory tests and procedures: Hemoglobin: (unspecified date) Unknown results; routine checkup: (unspecified date) unknown results, notes: realized the antibodies came back as negative; (unspecified date) Unknown results; Liver function test: (unspecified date) Unknown results; SARS-CoV-2 antibody test: (unspecified date) Positive, notes: She made some antibody tests after being sick with COVID-19; (unspecified date) Negative, notes: after the vaccinations, her antibody tests have been negative; (unspecified date) Negative, notes: she's negative for antibodies now; (Oct2022) Positive, notes: positive for both old and new antibodies; (01Jan2023) negative; (Jan2023) negative, notes: first week of Jan2023; (Jan2023) negative, notes: two weeks later in Jan2023; (20Mar2023) negative; (27Mar2023) negative; SARS-CoV-2 test: (15Jan2021) Positive, notes: first positive; (17Jan2022) Positive; (22Jan2023) Positive, notes: did a COVID-19 home test three days after 19Jan2023 and it was positive; Thyroid function test: (unspecified date) Unknown results; Vitamin D: (unspecified date) Unknown results. Clinical course: Concomitant medications included high cholesterol pills and vitamins. Patient has no prior vaccinations (within 4 weeks). Patient wants to report an adverse event with her Pfizer COVID-19 vaccines. She has COVID-19 two times in Jan2021 and Jan2022. She was sick first time for 12 weeks and then for 6 weeks. She started her Pfizer COVID-19 vaccinations in Aug2022. Received booster dose in Jan2023. She made some antibody tests after being sick with COVID-19, the tests were positive. However, after the vaccinations, her antibody tests have been negative. She thinks she received no protection from the vaccines. In Jan2021, she was sick for 12 weeks with COVID-19. Had long haulers. Had natural antibodies to the first week of Nov2021. She was first positive for COVID-19 on 15Jan2021; on 17Jan2022, after six tests, she was positive for COVID-19 again. She was sick for 6 weeks. Had natural antibodies until the third week in Nov222. On 02Aug2022, she received her first shot of the COVID-19 vaccine. She volunteers at a bingo hall and is around 300 other people because she knew she had antibodies. On 24Aug2022 was her second dose COVID-19 vaccine.  Her doctor has no idea why she's negative for antibodies now. Her doctor advised her that anyone else who received these shots has new antibodies. By getting her shot in Jan2023, she is not completely protected but there should be something to help her recover. She had an antibody test last Monday (20Mar2023) and it was negative. Her most recent antibody test was on 20Mar2023. She was called on 23Mar2023 with the results that she is negative for COVID-19 antibodies. The test was sent off to the clinic to be processed. Knew she previously had COVID-19 and that her natural antibodies would quit in between October and November. She wanted to make sure she was covered by getting the vaccines. She had a COVID-19 antibody test on Oct2022 and was positive for both old and new antibodies. She doesn't know the exact name of the antibodies, stating it's maybe IgGA or IgA or IgAA. The older antibodies are her natural antibodies showing up in her immune system. The new antibodies were showing up from the COVID-19 Vaccines. For two years in a row since she had COVID-19, if she still had antibodies, she was going to skip the booster dose of COVID-19 vaccine, but her bloodwork in the first week of Jan2023 was negative for COVID-19 antibodies. Had another set of labs two weeks later in Jan2023, a few days before 19Jan2023 and she was called notifying her she was negative for COVID-19 antibodies. She was negative twice for COVID-19 antibodies in Jan2023, so she proceeded to get the booster dose COVID-19 Vaccine on 19Jan2023. She was sick for 5 days after 19Jan2023. Had every symptom of COVID-19, including low grade fever. It only lasted for 5 days, and she recovered really fast. She did a COVID-19 home test three days after 19Jan2023 and it was positive. When she had last minute blood work, she was called on Thursday (23Mar2023) notifying her of her negative COVID-19 antibodies. This was after having two shots and then a booster dose less than six months ago. Patient was advised to get another booster dose. Called the health department and was told she can't have anymore COVID-19 vaccine boosters because the one she received on 19Jan2023 was the newest one and there are no more boosters after she received that one. AE required visit to just her HCP's office. He ordered lab work for the COVID-19 antibodies. The was last time was just a routine checkup to get labs for the year and then realized the antibodies came back as negative. Her HCP advised that just because she get a booster or a shot, doesn't mean she's totally protected, but she should have some form of antibodies to help recover so she doesn't get very ill. She was classified as having long hauler both times she had COVID-19. She spent a lot of time in isolation.  Patient is reading not to worry about the blood work for the COVID-19 antibody testing because it's irrelevant. States it's not irrelevant to her. If she's getting a negative test result, she's still able to be exposed. Knows she can be exposed with the having the shots, but it should show some type of immunity, even if doesn't stop her from getting sick. States she had a flu shot, but patient doesn't elaborate further. She is petrified because she was very sick the 12 weeks and 6weeks after she had COVID-19. Now being around people in the bingo hall because she is not protected. She was relying on the COVID-19 shot from getting her super sick. Knew she would probably get something from the COVID-19 Vaccine shot, like a cold, but now she has nothing. She could go right back to being sick for 12 weeks or 6 weeks again. The first time she had COVID-19 and was sick for 12 weeks, she spent more time in and in and out of isolation than she did at home. The last COVID-19 Vaccine booster they gave her, she is not supposed to get any more booster. So, what does she do because of that and she doesn't have antibodies? She is a little let down. Had better antibodies naturally than by the COVID-19 Vaccine shots. Pfizer was supposed to stop people from dying. Here she is one of the people who has zero antibodies. When she had COVID-19 both times, she went months with natural antibodies. Most people who get COVID-19 only have natural antibodies for 60-90 days, but hers were lasting for 9 months. The patient is asking after getting COVID-19 Primary series and booster dose, her antibody for Covid is still negative, she wants to know why. Patient said she was asked to call the Safety department to be properly assisted. She described she had 2 doses of the Pfizer-BioNTech COVID-19 Vaccine in Aug2022. Previously, she had COVID 2 times: one time in Jan2021 (she was sick for 12 weeks) and another time in Jan2022 (she was sick for 6 weeks). After the first infection, about every 4 months her doctor tested her for antibodies. Her doctor said she was producing antibodies on her own until November, which he said it was rare, she was a long holder. Back in Oct2022, she tested positive for COVID antibodies from the previous infection and from the vaccination. Then, she tested negative for antibodies on 01Jan2023, so she was recommended to receive the booster dose. She received this dose in 19Jan2023 and she was sick for about 5 days. She has tested negative for antibodies last week and yesterday (27Mar2023). She wanted to know why she is not producing antibodies after vaccination. Her doctors couldn't explain her case. She had antibodies from the infection for more time than from the vaccine; she thinks this should not be the case. She said that she has not developed any antibodies after 3 shots of the vaccine, and she can't have any more shots. She thinks she has absolutely no protection right now for COVID. Patient called stating that she had COVID 2 years ago on "17Jan2021" (also reported as '15Jan2021') and was sick for 12 weeks. Patient had COVID again on "15Jan2022" (also reported as '17Jan2022') and was also sick for "12 weeks" (also reported as '6 weeks'). Patient's antibody was high in Oct2022 but was negative for antibodies in Jan2023. Last Monday, a week ago from today patient was negative for antibodies. Patient was sick for 5 days after the vaccine with COVID-like symptoms. Investigation result received on 29Mar2023. Conclusion of Previously Completed Investigation: The complaint for Pfizer BioNTech covid-19 vaccine was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FP FN2908 (SF FN2904). A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. It was concluded that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. Sender's Comments: Linked Report(s): US-PFIZER INC-202300135793 Same reporter/drug/AE, different patient;US-PFIZER INC-202300135831 same reporter/patient/product, different event/dose;