Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 infection; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 infection) and DRUG INEFFECTIVE (Lack of drug effect) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     The patient's past medical history included Ovary removal (one ovary removed.) in 2007. Concurrent medical conditions included Hypothyroidism (No change reported.), High cholesterol (No change reported.), Seasonal allergy (No change reported.) and Menopause since 2014. Concomitant products included ROSUVASTATIN for High cholesterol, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Seasonal allergy.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 04-Jan-2022, the patient experienced COVID-19 (COVID-19 infection) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (COVID-19 infection) had resolved and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.         Allergies (medications, food and other products) was reported as none. Concomitant medication included thyroid medication (unspecified) to treat hypothyroidism. It was reported that the patient had seen gynecologist concerning the bleeding events and stated that the gynecologist referred the patient to a specialist.  No treatment information was reported.  Company Comment: This spontaneous case concerns a 47-year-old female patient, with no relevant medical history, who experienced the unexpected non-serious events of COVID-19 (AESI) ("got very sick") and Drug ineffective. The events occurred 9 months 20 days after the second dose of mRNA-1273 vaccine (15Mar2021), the 2nd dose administered 27 days after the 1st dose (16Feb2021). The booster dose (31Dec2021) was given 4 days before the onset of the events. There is no available information regarding clinical course and treatment medication. Additional information regarding adverse events that occurred after the booster dose (PT Postmenopausal haemorrhage, Impaired work ability, Loss pf personal independence in daily activities) can be found in linked case MOD-2022-523987. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-523987 (Patient Link).; Sender's Comments: This spontaneous case concerns a 47-year-old female patient, with no relevant medical history, who experienced the unexpected non-serious events of COVID-19 (AESI) ("got very sick") and Drug ineffective. The events occurred 9 months 20 days after the second dose of mRNA-1273 vaccine (15Mar2021), the 2nd dose administered 27 days after the 1st dose (16Feb2021). The booster dose (31Dec2021) was given 4 days before the onset of the events. There is no available information regarding clinical course and treatment medication. Additional information regarding adverse events that occurred after the booster dose (PT Postmenopausal haemorrhage, Impaired work ability, Loss pf personal independence in daily activities) can be found in linked case MOD-2022-523987. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.