Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19/ postive for Covid-19 and taking the full 5 day course of Paxlovid/ still testing positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19/ postive for Covid-19 and taking the full 5 day course of Paxlovid/ still testing positive) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 05121A, 020B21A and 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Obesity, Anxiety and Drug allergy. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE), AZELASTINE, ESCITALOPRAM, HYDROCHLOROTHIAZIDE, LOSARTAN, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), MULTI VITAMIN [ASCORBIC ACID;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;VITAMIN B1 NOS;VITAMIN B12 NOS;VITAMIN D NOS;VITAMIN E NOS], COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), VITAMIN C [ASCORBIC ACID], LEVOCETIRIZINE DIHYDROCHLORIDE (ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE]), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) for an unknown indication.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2022, the patient experienced COVID-19 (COVID-19/ postive for Covid-19 and taking the full 5 day course of Paxlovid/ still testing positive). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 03-May-2022 to 08-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19/ postive for Covid-19 and taking the full 5 day course of Paxlovid/ still testing positive) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 12-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 15-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 23-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant products included Leutin and Tri-chromium.  The Patient reported after testing postive for Covid on 03-May-2022 and took the full 5 day course of Paxlovid, the patient tested negative (with a home antigen rapid test). On 12-May-2022 all symptoms of patient had resolved and patient had not had a fever since 04-May-2022. On 14-May-2022 the patient had developed sore throat again and on 15-May-2022 it was worse and had cough. The patient had tested positive at home on 15-May-2022. On 23-May-2022 the patient was still positive . The patient had mild symptoms that had resolved but patient was having daily headaches at time of reporting.  Company Comment: This spontaneous case concerns a 53-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 which occurred 5 months 25 days after receiving the third dose of mRNA-1273 vaccine. It was reported that patient was treated with a 5-day course of Paxlovid and the patient had developed sore throat again on 14-May-2022 which was worsened with cough the next day. She was positive as on 23-May-2022. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 53-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 which occurred 5 months 25 days after receiving the third dose of mRNA-1273 vaccine. It was reported that patient was treated with a 5-day course of Paxlovid and the patient had developed sore throat again on 14-May-2022 which was worsened with cough the next day. She was positive as on 23-May-2022. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.