Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: First tested positive, May 4th/ tested negative for Covid on May 11th, but then a faint positive on a rapid test on May 12th/ Symptoms returned; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (First tested positive, May 4th/ tested negative for Covid on May 11th, but then a faint positive on a rapid test on May 12th/ Symptoms returned) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, FB-003C21A and 032B21A) for COVID-19 vaccination.     Concurrent medical conditions included GERD, Chronic migraine, Obesity and Seasonal allergy. Concomitant products included OMEPRAZOLE and LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (First tested positive, May 4th/ tested negative for Covid on May 11th, but then a faint positive on a rapid test on May 12th/ Symptoms returned). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 04-May-2022 to 09-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (First tested positive, May 4th/ tested negative for Covid on May 11th, but then a faint positive on a rapid test on May 12th/ Symptoms returned) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2022, SARS-CoV-2 test: positive (Positive) started taking Paxlovid on the evening  first tested positive, May 4th.. On 11-May-2022, SARS-CoV-2 test: negative (Negative) tested negative for COVID on a rapid test on May 11th.. On 12-May-2022, SARS-CoV-2 test: positive (Positive) a faint positive on a rapid test on May 12th.         Patient had allergic reaction to unspecified drug.  The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  The patient had previously received a COVID-19 Vaccine.  Symptoms returned on May 12th, though they were mild. Since then, patient not sure if patient had been symptomatic as any symptoms patient had were indistinguishable from seasonal allergies, and every day since then (patient had tested every other day, including 20th May), Patient  had tested strongly positive on a rapid test.  Company comment: This is a spontaneous case concerning a 42-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious AESI event of Covid-19. The patient received first and second dose of mRNA-1273 vaccine with appropriate dosage interval of 28 days and after approximately 6-7 months patient received third dose of mRNA-1273 vaccine. The event occurred approximately176 days after the third dose of mRNA-1273 vaccine administration. The event was described as, patient tested positive with Covid-19 and took Nirmatrelvir (Paxlovid) the same day with duration of 5 days. Patient tested negative in Covid-19 rapid test 2 days after the last dose of Nirmatrelvir (Paxlovid). However the day after, patient experienced mild Covid-19 symptoms and patient tested positive on Covid-19 rapid test. No other information surrounding the event was reported. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 42-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious AESI event of Covid-19. The patient received first and second dose of mRNA-1273 vaccine with appropriate dosage interval of 28 days and after approximately 6-7 months patient received third dose of mRNA-1273 vaccine. The event occurred approximately176 days after the third dose of mRNA-1273 vaccine administration. The event was described as, patient tested positive with Covid-19 and took Nirmatrelvir (Paxlovid) the same day with duration of 5 days. Patient tested negative in Covid-19 rapid test 2 days after the last dose of Nirmatrelvir (Paxlovid). However the day after, patient experienced mild Covid-19 symptoms and patient tested positive on Covid-19 rapid test. No other information surrounding the event was reported. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.