Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Fatigue, Pain in extremity, SARS-CoV-2 test, Vaccination failure
Clinical narrative: caller mentioned that she had her 4th Pfizer covid vaccine booster and recently was diagnosed with covid./ She stated they all have had the Pfizer Covid vaccine for their vaccinations.; caller mentioned that she had her 4th Pfizer covid vaccine booster and recently was diagnosed with covid./ She stated they all have had the Pfizer Covid vaccine for their vaccinations.; Caller states just sore arm and tiredness maybe after all of her COVID-19 vaccines; Caller states just sore arm and tiredness maybe after all of her COVID-19 vaccines; 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), on 25Jan2021 as dose 1, single (Batch/Lot number: unknown), on 15Feb2021 as dose 2, single (Batch/Lot number: unknown), on 10Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 20Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FJ9943) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing), notes: Comments: Migraine Caller states she has been getting migraines for a long time.; "Arthritis" (unspecified if ongoing), notes: Comments: Arthritis Caller states she was diagnosed with arthritis 2 years ago.; "Prediabetes" (unspecified if ongoing); "palpitations" (unspecified if ongoing). Concomitant medication(s) included: NIRMATRELVIR; RITONAVIR; METFORMIN taken for glucose tolerance impaired (ongoing); BYSTOLIC taken for palpitations (ongoing); LIVALO (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious), FATIGUE (non-serious) all with onset 2021, outcome "unknown" and all described as "Caller states just sore arm and tiredness maybe after all of her COVID-19 vaccines"; VACCINATION FAILURE (medically significant) with onset 29Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 29Apr2022, outcome "recovering" and all described as "caller mentioned that she had her 4th Pfizer covid vaccine booster and recently was diagnosed with covid./ She stated they all have had the Pfizer Covid vaccine for their vaccinations.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Apr2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: Question: Does Nurtec (Rimegepant) interact with Paxlovid?  Caller states that she takes the Nurtec for migraine and has recently felt the beginning of one coming.  She was also put on dexamethasone (unknown manufacturer) for her cough while she is being treated with the Paxlovid for her Covid infection.  She also stated that it is cloudy outside and that will also cause her to get migraines.  In addition, caller mentioned that she had her 4th Pfizer Covid vaccine booster and recently was diagnosed with Covid.  Her brother was also boosted with his 4th booster and recently was diagnosed with Covid.  And her son also has Covid but has not yet had a booster.  She stated they all have had the Pfizer Covid vaccine for their vaccinations. Medicinal Product Name as Reported by the Primary Source: Metformin. Additional Information for Other medicines Metformin: Caller states she has taken Metformin for several years. Her dose is 500 but she is not sure. She takes Metformin 3 times a day and she takes 3 pills. Additional Context: Warm transfer from (withheld) with Medical Information. Agent reports she has a consumer on line reporting she has been taking Paxlovid and has had the beginning of a migraine. Caller also reported she has been prescribed Dexamethasone. She reports she has had her 4th booster of Pfizer COVID-19 vaccine and recently got COVID. Caller also reported her brother also had the Pfizer COVID-19 vaccine and has gotten COVID and her son also has COVID. Agent reports the caller had a drug interaction question which was addressed. Caller clarifies the details provided by transfer agent. Caller states she got COVID a week after her 4th booster dose of the COVID-19 vaccine and clarifies a week or week and a half. She states she received the COVID-19 vaccine on Wednesday and had symptoms the following Thursday. Caller states her brother had his 4th booster dose of the COVID-19 Vaccine but she doesn't know the exact dates he got the booster. She states her brother got the booster dose of COVID-19 a week or so before her and tested positive yesterday for COVID and he just started Paxlovid today. Caller states her son also has COVID and has had his 3rd booster dose of the COVID-19 vaccine but hasn't gotten his 4th booster dose. She states her son received COVID from 2 kids that are unvaccinated. She states her other grandson after one shot of the COVID-19 vaccine got COVID and then got his second shot of the COVID-19 vaccine. Caller states she does not have the details on shots. Reporter details: Caller states she probably has the longest name in the system. She states she is not a doctor, nurse, or pharmacist but her husband is a doctor. Caller clarifies that her area code for her phone number is # not #. Prescribing HCP details: Caller states she does not have mailing address, email address, or phone number available. Positive for COVID after 4th COVID-19 vaccine booster dose: Caller states her symptoms started on Thursday and she tested positive on Friday, 29Apr2022. She didn't know when to test again but will test again tomorrow after she finishes her Paxlovid. She states that was a question she had as well. Caller states she is still having symptoms but her symptoms have definitely improved. Caller states she asked the pharmacist and was told she received the full dosage. She states the COVID-19 Vaccine was an injection in her left arm. Indication: Caller states she received the COVID-19 vaccine for protection for her age and for her grandkids as she thinks she gave COVID to her grandkids. Concomitant Medications: Caller states she does get a lot of medications but she doesn't have her medication list with her. Additional Vaccines Administered on Same Date of the Pfizer Suspect. Vaccines were not administered on same date with the Pfizer vaccine considered as suspect. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) were administered. For Lack of Efficacy, request the following information if not included in the initial report is not available. Caller declined to complete report on her brother, her son, and her grandson. Full details unable to be obtained. Caller states she is glad Pfizer has these vaccines and her symptoms could have been a lot worse if she didn't have the vaccines. Caller declined to complete reports for her brother, her son, and her grandson. Full details unable to be obtained. Caller phone went in and out during report. Attempts made to clarify details. There was product complaint to report. Product strength and count size dispensed not provided on call. Sample of the product available to be returned, if requested (Y/N) was not provided on call. Packaging sealed and intact was not provided on call.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.