Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Was going to go this week for her second booster dose, but then got sick.; COVID-19 positive on 27Apr2022 after receiving three COVID-19 Vaccines/she had a temperature and felt horrible, then found she was COVID-19 positive; It is now making her nauseous; Horrible bitter after taste; It woke her up out of a sound sleep between 3-4AM; This spontaneous case was reported by a nurse and describes the occurrence of DYSGEUSIA (Horrible bitter after taste), SLEEP DISORDER (It woke her up out of a sound sleep between 3-4AM), ILLNESS (Was going to go this week for her second booster dose, but then got sick.), COVID-19 (COVID-19 positive on 27Apr2022 after receiving three COVID-19 Vaccines/she had a temperature and felt horrible, then found she was COVID-19 positive) and NAUSEA (It is now making her nauseous) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 008B212A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced SLEEP DISORDER (It woke her up out of a sound sleep between 3-4AM). On 27-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSGEUSIA (Horrible bitter after taste), COVID-19 (COVID-19 positive on 27Apr2022 after receiving three COVID-19 Vaccines/she had a temperature and felt horrible, then found she was COVID-19 positive) and NAUSEA (It is now making her nauseous). On an unknown date, the patient experienced ILLNESS (Was going to go this week for her second booster dose, but then got sick.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) on 27-Apr-2022 for COVID-19, at a dose of three tablets twice a day, in the morning and evening,. At the time of the report, DYSGEUSIA (Horrible bitter after taste) had not resolved and SLEEP DISORDER (It woke her up out of a sound sleep between 3-4AM), ILLNESS (Was going to go this week for her second booster dose, but then got sick.), COVID-19 (COVID-19 positive on 27Apr2022 after receiving three COVID-19 Vaccines/she had a temperature and felt horrible, then found she was COVID-19 positive) and NAUSEA (It is now making her nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2022, SARS-CoV-2 test: positive positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient ethnicity was reported as other caucasian.  Patient did not take any concomitant medications.   Paxlovid related information reported as  'Paxlovid came in blister package & due to rip off/light print could not able to locate lot number. Patient took the dose as one (100mg) ritonavir tablet and two (150mg) nirmatrelvir tablets with total of 30 tablets. Conducted Positive COVID-19 test on Wednesday morning. Had a tele-med appointment with her doctor and discussed the new anti-viral, Paxlovid. Now she noticed it after every dose. She was putting off taking her next dose It did eventually go away, but it takes four hours. Was chewing gum for an hour because she thought it helped. She had been drinking a lot of water and being cognizant of being hydrated. At 4AM she still had that icky taste in her mouth. She swished her mouth with toothpaste and took the gum out. It helped for a little bit. Still had the horrendous bitter taste in her mouth. Product compliant involved with Paxlovid was unable to locate lot number and expiry date. It was still annoying. Company comment- This spontaneous case concerns a 61-year-old female patient receiving PAXLOVID, who experienced the unexpected AESI COVID-19 along with the non-serious events of dysgeusia and nausea approximately 5 months and 8 days days after a booster dose of mRNA-1273 vaccine was administered. After she got a positive COVID-19 test she started taking the new anti-viral, PAXLOVID (ritonavir/nirmatrelvir). She experienced an icky horrendous bitter taste in her mouth. Treatment with PAXLOVID remains as a confounder for the events dysgeusia and nausea.  The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-557706 (Patient Link).; Sender's Comments: This spontaneous case concerns a 61-year-old female patient receiving PAXLOVID, who experienced the unexpected AESI COVID-19 along with the non-serious events of dysgeusia and nausea approximately 5 months and 8 days days after a booster dose of mRNA-1273 vaccine was administered. After she got a positive COVID-19 test she started taking the new anti-viral, PAXLOVID (ritonavir/nirmatrelvir). She experienced an icky horrendous bitter taste in her mouth. Treatment with PAXLOVID remains as a confounder for the events dysgeusia and nausea.  The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.