Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, Dysgeusia, SARS-CoV-2 test
Clinical narrative: is the bitter taste a known side effect" & "bitter taste and she would like to know if its coming from her pill or if its a liver problem?; Tested Positive for COVID -19; Lack of efficacy; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested Positive for COVID -19), DRUG INEFFECTIVE (Lack of efficacy) and DYSGEUSIA (is the bitter taste a known side effect" & "bitter taste and she would like to know if its coming from her pill or if its a liver problem?) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 022M20A and 007M20A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) tablet for COVID-19 treatment.    The patient's past medical history included COVID-19 pneumonia (hospitalized) in January 2021. Concurrent medical conditions included Pollen allergy and Visual impairment.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) 6 dosage form once a day. On 09-May-2022, the patient experienced COVID-19 (Tested Positive for COVID -19) and DRUG INEFFECTIVE (Lack of efficacy). On 15-May-2022, the patient experienced DYSGEUSIA (is the bitter taste a known side effect" & "bitter taste and she would like to know if its coming from her pill or if its a liver problem?). At the time of the report, COVID-19 (Tested Positive for COVID -19) had not resolved and DRUG INEFFECTIVE (Lack of efficacy) and DYSGEUSIA (is the bitter taste a known side effect" & "bitter taste and she would like to know if its coming from her pill or if its a liver problem?) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Body temperature: 101 Her fever was 101 degrees and 100 fever was lower before like 100 degrees Fahrenheit. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medications were not reported. Vision was not good and needed glasses to read vaccine card. She had symptoms and was sick and had to put on this medication. She took the medication there was a bitter taste and she would like to know if its from her pill or if its a liver problem. She was also having a little nausea and saliva was so bitter. Twenty minutes after she took it, it started with the bitter taste, it started right away. She did not have a lot of side effects and was wondering if bitterness if from medication or her organs. When asked for start date of nausea, she said it was not bad and was very small and will not say it was a side effect. COVID symptoms started, and she thought it was allergies, because they have a lot of pollen Symptoms started Thursday. She got tested on Saturday that, she was positive. She got fever, sore throat. She knows how the COVID works. With the first COVID, she did not have headache. She has head congestion like a pressure in her head with congestion and runny nose that was clear. In order to get rid of the bitter taste she takes lots of water with the medication and then drinks milk and honey. she would like to know if it was okay to take the Pill with Milk and honey.  Paxlovid was started at night. The pharmacist wrote down which pills to take: 2150mg tablets Nirmatrelvir and 1100 mg of Ritonavir twice daily without food for five days. Lot number for fourth dose was reported as Lot 005M2LA or 005M21A.   This case was linked to MOD-2022-571207 (Patient Link).  Company Comment: This spontaneous case concerns a 70  year  old female patient with no relevant medical history, who experienced the unexpected, non  serious AESI of COVID  19, 4 days after the fourth dose of mRNA-1273 vaccine. The patient received the first two doses in an appropriate schedule of vaccination, hence, drug ineffective is considered. Since she was feeling sick and tested positive for COVID, she was prescribed treatment with Paxlovir, considering she was hospitalized due to COVID  19 pneumonia (before vaccination with mRNA  1273). For COVID  19, no further clinical information was available for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 70  year  old female patient with no relevant medical history, who experienced the unexpected, non  serious AESI of COVID  19, 4 days after the fourth dose of mRNA-1273 vaccine. The patient received the first two doses in an appropriate schedule of vaccination, hence, drug ineffective is considered. Since she was feeling sick and tested positive for COVID, she was prescribed treatment with Paxlovir, considering she was hospitalized due to COVID  19 pneumonia (before vaccination with mRNA  1273). For COVID  19, no further clinical information was available for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report.