Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: She got COVID after being vaccinated with all Pfizer COVID vaccines available; She got COVID after being vaccinated with all Pfizer COVID vaccines available; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "She is an asthmatic" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She got COVID after being vaccinated with all Pfizer COVID vaccines available". The patient underwent the following laboratory tests and procedures: Body temperature: 101.2, notes: The highest temperature she did record was 101.2; always under 98.6, notes: She recorded temperature always under 98.6 sometimes in the 94 and 95 range; 94, notes: She recorded temperature always under 98.6 sometimes in the 94 and 95 range; 95; SARS-CoV-2 test: Positive.  Clinical course: It was reported that she got COVID after being vaccinated with all Pfizer COVID vaccines available. The report was not related to a study or programme. The reason for no lot number of COVID vaccine was reported as reporter unwilling to complete the report. Other Products were not Provided. She just had an Inquiry. She had spoken with her pharmacist in (withheld).She did that with regularity with questions.She was an asthmatic. On, 25Mar2023, she had symptoms while driving. She didn't know what was going on, but knew she had to get to where she was going. She was going to visit her grandson at her daughter's house. She asked her daughter to take a COVID test at home. It was positive. So then the reporter took one. It was also positive. The reporter was fully vaccinated with all available Pfizer COVID vaccines. She had a nursing background. She had good self care and follows instructions. Her symptoms from COVID were mild. She had lots of mucus and coughing. She just had cold like symptoms. The highest temperature she did record was 101.2. The next day and following, she self quarantined. She recorded temperature always under 98.6 sometimes in the 94 and 95 range. Which was subnormal. Her and her daughter went to urgent care in (withheld) on 26Mar2023. Her symptoms were not approving. She was in the house with her grandson who has issues. The reporter thought she was the carrier, but the grandson was unable to go to school because of this. He tested positive as well. She self quarantined for 2.5 weeks. Her symptoms were not abiding. She was not able to reach her primary doctor. Once she finally spoke with her primary, 2.5 week later things were improved. The doctor asked if she opted to take Paxlovid when she visited the urgent care. She told her no. She didn't ask for paxlovid. She was on day 2 of a positive test. She had a second covid flu and something test that tests for three things. It was positive for COVID too. She was instructed at urgent care to continue isolating and check in with her primary. Which she tried to do, but they wouldn't call her back. She continued isolating for a period of time until she felt better. She was told to test for negativity once she felt better. She still hadn't been able to get a negative test. At testing centers tests were not readily available. The only available ones were the ones in drug stores, and she didn't like those since they were just positive or negative symbols. She was symptom free now. She received a 13 page print out from the ER physician, and she read it carefully. The doctor didn't recommend Paxlovid because there were too many side effects, and it was still an investigational drug. The reporter was also on a statin for cholesterol. Which she was not happy about. She wished they could put her on a substitute to get off of it. But her doctor said she would be on it for life. She read a lot it was just her nature. She was just wondering if this 13 page print out that was revised on 26Sep2022 had been updated since then. Does Pfizer have updated information. Please just transfer her. She didn't want to do a report. No other details provided. There was a product complaint to report. Description of Product Complaint: Description of complaint: The reporter was fully vaccinated with all available Pfizer COVID vaccines. Reporter tested positive for COVID and had cold like symptoms. Reporter declined report. Product strength and count size dispensed, Additional lot numbers were not provided. It was not provided whether a sample of the product available to be returned, if requested, whether packaging was sealed and intact. Consumer, patient, caregiver: not provided. Reporter was a retired RN. Reporter confirmed that she was given 13 pages handout (Fact sheet) of Paxlovid that was revised on 26Sep2022(from an urgent care physician). She wanted to know if since then Pfizer had new updated information. She asked if the product was under emergency used only especially for those who were at high risk/severe cases. She had been previously fully vaccinated with all Pfizer covid-19 vaccines and did test positive for covid infection and she never took the Paxlovid. She did asked her urgent care physician; 3 decades plus asthmatic adult onset, well controlled with Advair hfa she had been using it pretty consistently, not properly, not always, She didn't get all the 4 puffs in a day as instructed, but it was considered well controlled. She isolated for 3 weeks after testing positive with covid despite having the Pfizer covid19 vaccine history. She came in contact with someone, she maintained masking. The person on desk (where she stayed in) she was masked and she was not, and she was admitted and several of her colleagues were out sick, she had asthma and coughing quite a bit. She thought that had been her source (of covid infection) she had been on many places. The contact at the desk happened on a weekly basis on a short period of time. Was it recommended for emergency use for those who are at high risk/severe cases. Which she was never told in which she was in on that category as an asthmatic. She did not had a terrible week (3 weeks of covid positive) still having symptoms and they were abating and mild. Her doctor did not recommend taking Paxlovid on her case based on her diagnosis and how she utilizes the Advair and because of the risk factors that could apply. Reporter also asked the timeline when Paxlovid first came out in the market, but then she declined and said that it was just an education guess. She infected one of them (pertaining to her grandsons), he's also vaccinated (with Pfizer covid-19 vaccines) he did not had a long positive with a fever, missed an important musical piece, 13 years old.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, an association between the reported events DRUG INEFFECTIVE  , COVID-19  and The suspected drug cannot be ruled out.