Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Insomnia, Laboratory test, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Caller said she tested positive for Covid-19 on Friday; Caller said she tested positive for Covid-19 on Friday; she hadn't been sleeping; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 68-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "She has the beginning of COPD" (unspecified if ongoing), notes: She states she has the beginning of COPD even though she never smoked; "never smoked" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunisation. The following information was reported: INSOMNIA (medically significant) with onset 2023, outcome "not recovered", described as "she hadn't been sleeping"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Dec2023, outcome "recovered" (Dec2023) and all described as "Caller said she tested positive for Covid-19 on Friday". The events "caller said she tested positive for covid-19 on friday" and "she hadn't been sleeping" required physician office visit. The patient underwent the following laboratory tests and procedures: lab values: (Dec2023) no lines; (unspecified date) negative, notes: other had one line; SARS-CoV-2 test: (08Dec2023) Positive, notes: Treatment of Covid-19; (Dec2023) Negative, notes: it came out negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Caller said she started taking taking her Paxlovid pills today and she tested negative for Covid-19. She would like to know if she should continue taking it. Caller stated she didn't feel good last week and couldn't work on Thursday. She had her "booster shot" 9 days before that. Friday she tested positive for Covid on a home test and the doctors office prescribed Paxlovid. She stated she had fever, only slept 5 hours, couldn't eat and only had liquids, had experienced diarrhea and vomiting. The NP told her the script will had her taking 3 pills in the morning and 3 pills in the evening. Her script was picked up Friday afternoon and the NP said she could start it Saturday. She then tested again with two different tests- one had no lines and the other had one line, which was a negative result. She stated she had the beginning of COPD even though she never smoked. She will be 69 years old. Caller said she tested positive for Covid-19 on Friday so she didn't start the medication but her doctor told her to start taking the medication today, but after she started it she went and took a test for Covid-19 and it came out negative. Caller said she only took one set of pills but she wanted to know if she should keep taking them. Caller also mentioned that she was confused with the prescription because she was older and she had fevers, and didn't eat anything, and she hadn't been sleeping. Caller also stated that she had been coughing and choking, and gagging and had been fighting the Covid-19 virus even after taking the booster shot 10 days prior.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.