Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I tested positive for Covid 19.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I tested positive for Covid 19.) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003k21-2a, 939902, 012A21A and 004M20) for COVID-19 vaccination.     Concurrent medical conditions included Lung cancer, Asthma and Drug allergy (unknown drug). Concomitant products included ATORVASTATIN from 30-Apr-2021 to 24-May-2022, LEVOTHYROXINE SODIUM (SYNTHROID) from 02-Feb-2022 to an unknown date, MONTELUKAST from 20-Jan-2021 to an unknown date, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) from 10-May-2021 to an unknown date, ACETYLSALICYLIC ACID (ASPIRIN LOW) from 24-Apr-2021 to an unknown date, LINUM USITATISSIMUM SEED OIL, OENOTHERA BIENNIS OIL, VACCINIUM MYRTILLUS OIL (RETAINE FLAX) from 04-Apr-2022 to an unknown date, CALCIUM, MAGNESIUM, ZINC (CALCIUM + MAGNESIUM + ZINK) from 07-Feb-2022 to an unknown date and ZINC from 04-Feb-2022 to an unknown date for an unknown indication.   On 28-Jan-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (I tested positive for Covid 19.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 24-May-2022 to 29-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (I tested positive for Covid 19.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.  Device Date: 05-Jun-2022  Company Comment: This Spontaneous case concerns a 78-year-old female patient, with relevant medical condition of lung cancer, who experienced the unexpected, non-serious AESI of COVID-19 (after a SARS-CoV-2 positive test), which occurred on an unknown date after the fourth dose of mRNA-1273 vaccine. The patient received treatment for COVID-19 with Nirmatrelvir, Ritonavir (Paxlovid). Outcome was unknown. Additional information was solicited for accurate and complete medical review. Medical condition of lung cancer remains a confounder for COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This Spontaneous case concerns a 78-year-old female patient, with relevant medical condition of lung cancer, who experienced the unexpected, non-serious AESI of COVID-19 (after a SARS-CoV-2 positive test), which occurred on an unknown date after the fourth dose of mRNA-1273 vaccine. The patient received treatment for COVID-19 with Nirmatrelvir, Ritonavir (Paxlovid). Outcome was unknown. Additional information was solicited for accurate and complete medical review. Medical condition of lung cancer remains a confounder for COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.