Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Caller states she tested positive for Covid on Saturday; Caller states she tested positive for Covid on Saturday; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 10Feb2021 (Lot number: EN6201) at the age of 67 years as dose 1, single, administered in deltoid right, administration date 03Mar2021 (Lot number: EM9809) as dose 2, single and administered in deltoid left, administration date 15Nov2021 (Lot number: VH8030) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: Verbatim: high blood pressure; "Diverticulum" (unspecified if ongoing), notes: Verbatim: Diverticulosis.  Vaccination Facility Type was Pharmacy/Drug Store. There was no prior vaccinations (within 4 weeks). Concomitant medication(s) included: METOPROLOL taken for hypertension. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Feb2022, outcome "unknown" and all described as "Caller states she tested positive for Covid on Saturday". There was no emergency room or physician's office visit due to the adverse events. Caller stated she tested positive for Covid on Saturday, 12Feb2022 and was given Paxlovid package to take for 5 days. Stated it was 3 pills in the morning and 3 pills in the evening for 5 days. Caller stated her concern was the side effects she had from it, she had a little diarrhea, a bad bitter taste in her mouth since she started taking it and the bitterness in her mouth doesn't go away. Caller stated the thing was she still has sweats like if she had a fever but she doesn't feel like she has a high fever but goes into sweats. Caller was asking with this medication is it safe to take Tylenol. Caller stated she had flu symptoms and was starting to get better but Monday she called her provider and was put on this and feels from getting better she had little side effects from the medication and feels iffy and was wondering if she could take the Tylenol to help herself. Caller stated her symptoms started after taking the medication, the bitterness was half an hour after taking her 1st dose she had that taste and it doesn't go away until about half an hour before her next dose. Stated she drinks water and tea and takes hard candy and that kind of relieves it but as soon as the candy taste is out the bitter taste is back. Caller stated it is causing restless nights as she tosses and turns and feels it and gets up and washes her mouth and the bitterness doesn't go away. Caller relayed the diarrhea started when she 1st did the Covid test on Saturday and it was a little bit and Sunday a little bit and by Monday it was like starting a little and wasn't too bad and then when she started taking the medication she still has it but not as much as before. States when she eats she had to go and she has a medical condition, diverticulosis, and has problems with her GI system sometimes so it is hard to determine if it's from the medication, the Covid or from her condition. Caller stated the sweats she usually got sweats but with taking this medication she felt a little warm feeling and wonders if she had a fever but she doesn't feel fever she felt something strange of it. States if she was a little active like going to the kitchen or washing dishes she feels damp or sweaty and she sweats very much but taking something different she doesn't know if it is triggering it a little more. Caller stated she got up today to get some clothes out and to disinfect her room and she got so sweaty and was like Jesus Christ she was sweating was she hot or was it the medication or a fever but she doesn't feel like she has a fever, she would know if it was 101 or 102. Caller stated she tested positive for Covid Saturday morning and called her doctor Monday morning and told her by the way she tested positive and was taking over the counter medication. States she had Robitussin cough. Tylenol and flu with cold and was holding up pretty good and feeling a little better when she called her. Stated her doctor recommended it as she is over 65 and she started it Tuesday, 15Feb2022 around 5pm. States that today was her 4th dose at 6am. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Feb2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: As there is limited information in the case provided, the causal association between the ~Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200291683 Same patient, different dose, different event