Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Hepatic enzyme, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 (Oropharyngeal pain, nasal congestion, Pharyngeal erythema, Fatigue, Cough and Sneezing); Tested positive with an at home antigen test on 21May2022; Tested positive PCR for Covid 19 on 11MAY2022; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 (Oropharyngeal pain, nasal congestion, Pharyngeal erythema, Fatigue, Cough and Sneezing)), SARS-COV-2 TEST POSITIVE (Tested positive PCR for Covid 19 on 11MAY2022) and SARS-COV-2 TEST POSITIVE (Tested positive with an at home antigen test on 21May2022) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A, 016M20A and 011F21A) 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 Gallbladder removal (She had common bile duct stones back in the fall) in 2020. Concurrent medical conditions included Bile duct stone (history of high liver enzymes due to the common bile duct stones and  asymptomatic.), Anxiety and Allergy to animal (Cat). Concomitant products included CETIRIZINE HYDROCHLORIDE (CETRIZINE) for Allergy to animal, SERTRALINE for Anxiety, OMEPRAZOLE for Common bile duct stone.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (Oral) 300 mg nirmatrelvir, two 150 mg tablets and 100 mg ritonavir taken orally. On 11-May-2022, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive PCR for Covid 19 on 11MAY2022). On 21-May-2022, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive with an at home antigen test on 21May2022). On an unknown date, the patient experienced COVID-19 (COVID-19 (Oropharyngeal pain, nasal congestion, Pharyngeal erythema, Fatigue, Cough and Sneezing)). At the time of the report, COVID-19 (COVID-19 (Oropharyngeal pain, nasal congestion, Pharyngeal erythema, Fatigue, Cough and Sneezing)), SARS-COV-2 TEST POSITIVE (Tested positive PCR for Covid 19 on 11MAY2022) and SARS-COV-2 TEST POSITIVE (Tested positive with an at home antigen test on 21May2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 19-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 20-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 21-May-2022, SARS-CoV-2 test: positive (Positive) Positive. In 2022, SARS-CoV-2 test: negative (Negative) Negative and negative (Negative) Negative. On an unknown date, Hepatic enzyme: high (High) history of high liver enzymes due to the common bile duct stones.         Caller just wanted to provide all this information for data collection. Caller confirms above information and adds that for 5 days of antigen testing she did, 4 of the 5 days she was negative, 1st PCR test come back positive she shouted her doctor a message through the portal and her doctor sent in a prescription for the Paxlovid right away. Events: All ongoing. Her chief complaint was a stuffy nose, sore throat but no swelling and the back of her throat is red but no pustules and no sign of infection. Reports fatigue and that runs like a roller coaster, she has a few hours of feeling great and then not great. Outcome of all events: it fluctuates, it is not worse, just feels like a rotten cold. Caller stated that she took the doses within an hour of each other on the 12 hour mark. Attempted clarification and caller states that she started at 5:30pm and then would take the morning dose between 5:30am and 6:30am. Caller stated that while she was on the Paxlovid she did not take the omeprazole, she was concerned it would interfere with the absorption. Caller reported that she had her gal bladder removed in 2020. She had common bile duct stones back in the fall, then states that was she take the omeprazole and she was concerned about her liver. She has history of high liver enzymes due to the common bile duct stones. She has been asymptomatic for common bile duct stones. Then adds, in fact last week she was due for a physical and she would have had her LFT's checked for a follow up and she wants to know what her liver function test is since she took Paxlovid. States she will have to wait another week for that since she was positive for COVID still. Company Comment: This is a Spontaneous case concerning a 57-years-old female patient, with no relevant medical history reported, who experienced the non-serious unexpected AESI of COVID-19, in an unknown date after the administration of the 3rd dose of the mRNA-1273 vaccine in an appropriate schedule of vaccination. Also, the special situation of Vaccination Failure was reported in this case. Relevant test was performed: COVID-19 rapid home tests positive. Patient presents Oropharyngeal pain, nasal congestion, Pharyngeal erythema, Fatigue, Cough and Sneezing and the outcome of those events at the time of the report was Unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event assessed as non-serious.; Sender's Comments: This is a Spontaneous case concerning a 57-years-old female patient, with no relevant medical history reported, who experienced the non-serious unexpected AESI of COVID-19, in an unknown date after the administration of the 3rd dose of the mRNA-1273 vaccine in an appropriate schedule of vaccination. Also, the special situation of Vaccination Failure was reported in this case. Relevant test was performed: COVID-19 rapid home tests positive. Patient presents Oropharyngeal pain, nasal congestion, Pharyngeal erythema, Fatigue, Cough and Sneezing and the outcome of those events at the time of the report was Unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event assessed as non-serious.