Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: She says she had her booster, clarified to second booster shot, a month before she tested positive; She says she had her booster, clarified to second booster shot, a month before she tested positive; 18th with a fever of 100.2 and pretty horrific sore throat]; 18th with a fever of 100.2 and pretty horrific sore throat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from product quality group. The reporter is the patient. A 65-year-old female patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL8982), on 17Feb2021 as dose 2, single (Lot number: EM9809), on 27Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown, Expiration Date: 31Oct2021) and on 22Apr2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history included: "Hip replaced" (unspecified if ongoing), notes: she had a hip replaced on the 17May. There were no concomitant medications. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 18May2022, outcome "unknown", described as "18th with a fever of 100.2 and pretty horrific sore throat"; PYREXIA (non-serious) with onset 18May2022, outcome "unknown", described as "18th with a fever of 100.2 and pretty horrific sore throat]"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18May2022, outcome "unknown" and all described as "She says she had her booster, clarified to second booster shot, a month before she tested positive". The patient underwent the following laboratory tests and procedures: Body temperature: (18May2022) 100.2, notes: fever of 100.2; SARS-CoV-2 test: (unspecified date) Positive; (18May2022) Positive, notes: positive for COVID-19 on the 18May and 23May; (23May2022) Positive; (06Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, pyrexia, oropharyngeal pain.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Additional Context: Agent reports caller is a consumer of Paxlovid who wanted to report her experience with Paxlovid and mentioned both she and her husband have recently completed a five-day course of Paxlovid. Agent reports originally tested positive for COVID-19 on the 18May and 23May. Agent reports both have just completed another COVID test and both tests came back positive. Agent reports she says they are asymptomatic and are just looking to share the timeline they had regarding previous infection, their Paxlovid treatment, and the reinfection. Agent reports transfer is because mentioned both of them tested positive again. Agent reports she mentioned that they spent about 16 days in isolation already. Agent reports her's husband is 67 years old, Agent reports she also mentioned she knows of two other friends who experienced the same rebound and estimates the age of the two other friends could be in their mid-60s as well. she confirms above details. She says that she doesn't have her Paxlovid packaging anymore to provide NDC/LOT/EXP, unknown, because she discarded her box. She says she said to man previously she finished her treatment 24May. She says she started taking Paxlovid on the afternoon of the 19th after testing positive on 18May, her doctor called the script in on the 19th. She says her recent positive was on Monday afternoon at 12:30PM, which she was asymptomatic at the time. She says she did not take a test between the positive tests. She says they have spent 16 out of the last 21 days in isolation. She says they did 10 days isolation in full that CDC recommended, with 5 days then additional 5 days wearing a mask, and since they were both positive within 5 days of each other, they stayed separate until Monday or Tuesday last week on 30May or 31May. Historical adverse event include she says one reason was she had a hip replaced on the 17th of May and stayed overnight at the hospital and woke up morning of 18th with a fever of 100.2 and pretty horrific sore throat, but she doesn't think she got COVID in the hospital. she says both she and her husband had Pfizer COVID-19 vaccines. She says she had her booster, clarified to second booster shot, a month before she tested positive, and her husband # had his two weeks before. She says they have handwritten vaccine cards. She says her first dose was given 27Jan2021 NDC/EXP: not provided on card, with LOT: EL8982. She says her second dose was given 17Feb2021 with NDC/EXP: not provided on vaccine card, and LOT: EM9809. She says her third dose was given 27Aug2021 with NDC not provided on vaccine card and EXP: 31Oct2021. Third dose LOT either not provided or inadvertently deleted by call handler. she says her fourth dose was given 22Apr2022 with NDC: not provided on vaccine card, LOT: FP4554, and EXP: not provided on vaccine card. she declines to complete a report on the people they know in their 60s and says she doesn't know anything about them other than the couple knows they too tested positive after they finished their prescription of Paxlovid. No further details captured, reported, or documented at this time about the other couple. she says the thing is because Paxlovid is EUA, they should have in recommendations that there should have been a follow up by Pfizer or drug company or physician where they have a test in 5 days after finishing. She says a follow up to add data, since there have been two million doses released globally, and valuable information but no one followed up after. She says they got their vaccines and they had follow up where they got their vaccines with 10 questions. She says they thought they would get in touch with Pfizer to let them know what their experience was, to help Pfizer get data and protocol reports to be out of EUA widely.  Description of Product Complaint: Description of complaint: Pfizer COVID-19 vaccine: she had four doses of Pfizer COVID-19 vaccine and tested positive for COVID-19. Product strength and count size dispensed: four doses. Additional lot numbers: LOT: EL8982, LOT: EM9809. Third dose LOT either not provided or inadvertently deleted by call handler. LOT: FP4554. Is a sample of the product available to be returned, if requested (Y/N): not provided. Packaging sealed and intact? not provided.  No follow-up attempts are needed. No further information is expected.