Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Cough, Decreased appetite, Diarrhoea
Clinical narrative: tested positive for Covid; tested positive for Covid; headache; cough; sore throat; She lost some weight in the last few days because for five days she had no appetite;; She lost some weight in the last few days because for five days she had no appetite;; nausea; diarrhea; she had 99.7 degree fever; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 03Apr2021 as dose 2, single (Lot number: EP6955), in left arm and on 02Dec2021 as dose 3 (booster), single (Lot number: FJ8762) at the age of 75 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "tested positive for Covid"; HEADACHE (non-serious), outcome "unknown"; COUGH (non-serious), outcome "unknown"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; WEIGHT DECREASED (non-serious), DECREASED APPETITE (non-serious), outcome "unknown" and all described as "She lost some weight in the last few days because for five days she had no appetite;"; NAUSEA (non-serious), outcome "unknown"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; PYREXIA (non-serious), outcome "unknown", described as "she had 99.7 degree fever". The patient underwent the following laboratory tests and procedures: Body temperature: she had 99.7 degree fever, notes: she had 99.7 degree fever; SARS-CoV-2 test: Positive, notes: She tested positive for Covid Tuesday; Weight: her weight is normally 118-119, notes: Weight: She lost some weight in the last few days because for five days she had no appetite; her weight is normally 118-119 now 115-116; this happened before taking Paxlovid; now 115-116, notes: Weight: She lost some weight in the last few days because for five days she had no appetite; her weight is normally 118-119 now 115-116; this happened before taking Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19, headache, cough, oropharyngeal pain, weight decreased, decreased appetite, nausea, diarrhoea, pyrexia.  Clinical course: Reporter has had three Pfizer Covid-19 vaccines, with her last in December. On Sunday or Monday, she started feeling funny. She tested positive for Covid Tuesday. She was feeling bad with cough, sore throat, headache and was told by someone about Paxlovid. She called her doctor and started taking Paxlovid yesterday. The taste in her mouth is unbearable, it's like an aftertaste. Besides her symptoms of Covid itself, which is some nausea, diarrhea, and now with the taste; she doesn't want to stop taking it; her symptoms are kind of persistent of sort of mild to moderate with Covid; Her question was if her symptoms would subside on it's own because it's a virus and they go away;  she started taking the medication yesterday and took it this morning;  if she stops taking is it going to be bad or worse?  will it aggravate the condition? She read that it would be bad; because she doesn't see herself having shortness of breath that would take to her to the hospital; she is having some cough but her breathing is ok; she had 99.7 degree fever on Monday or Tuesday. Compared to other people that died with Covid maybe it's nothing; it's really bad plus the nausea before started taking the medication. She lost some weight in the last few days because for five days she had no appetite; her weight is normally 118-119 now 115-116; this happened before taking Paxlovid. She got the prescription by her own request. She called her doctor and he provided it; hasn't been much discussion and wanted to get better quicker; Start date: after the first dose; a package comes with 5 packets; after the first day dose, she had the taste which subsided after a few hours; after the night dose she went to bed and didn't have the chance to feel the taste, it's so bad it will wake you up; this morning she thought maybe she was desensitized but it came back. Products: She has the box and insert with small letters which she's not up to read;  she doesn't see NDC number; lot: she was reading the blister pack, she hopes she can read it, she has to turn on the light, she thinks she needs a magnifier, she see's the Lot in the package for the medication but it is really hard to read: the other one she can read better, the lot number is G, O or zero, 4718. 150mg; 100mg dose pack. Dose was not changed. she thinks she is going to heal and she is through the worst part; the taste is causing her not to eat which is causing weakness; and she doesn't think she's going to have shortness of breath or hospitalization and she is riding the virus well. She doesn't remember the time of vaccination. No treatment or medical intervention was needed. Vaccine was not administered at facility. No emergency room or physician office required for adverse event. No other vaccinations was taken within four weeks prior to the first administration date of the suspect vaccine(s). No prior vaccination. Patient had no medical history, medical history relevant to adverse event, relevant test, secondary sites, predisposing factors. No culture performed. No Serotyping done. She took Tylenol for generalized pain, but none on the day of vaccination. She doesn't feel that she can continue taking the medication. DCA declined. Product strength and count size dispensed: package total dose cartons, which carton has 20 tablets in 5 blisters, five 150mg each and two ritonavir 100mg each; 150mg nirmatrelvir and 100mg ritonavir.  Description of Product Complaint: Description of complaint: Caller taking Paxlovid. She has the box and insert with small letters which she's not up to read. She doesn't see NDC number. She is reading the blister pack and she hopes she can read it. She has to turn on the light, she thinks she needs a magnifier, she see's the Lot in the package for the medication, but it is really hard to read; the lot number is G, O or zero, 4718; it is very hard to read; if printed it has to be clear; so much information; it's hard to find. Product strength and count size dispensed: package total dose cartons, which carton has 20 tablets in 5 blisters, five 150mg each and two ritonavir 100mg each; 150mg nirmatrelvir and 100mg ritonavir. No additional lot numbers reported. Packaging was sealed and intact.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded