Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Eye irritation, Fatigue, Feeling guilty, SARS-CoV-2 test
Clinical narrative: My Mental Symptoms were: Overwhelmed with anxiety, shame/guilt, overthinking, worry; My Mental Symptoms were: Overwhelmed with anxiety, shame/guilt, overthinking, worry; exhaustion; major dehydration; burning eyes; bedridden; drug ineffective; became COVID positive; I puke for hours the next day following my second dose,vomiting; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (became COVID positive) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Polycystic ovarian syndrome. Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and MAGNESIUM for Polycystic ovarian syndrome.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced VOMITING (I puke for hours the next day following my second dose,vomiting). On 27-Jul-2021, the patient experienced COVID-19 (became COVID positive) (seriousness criterion medically significant) and DRUG INEFFECTIVE (drug ineffective). On an unknown date, the patient experienced FEELING GUILTY (My Mental Symptoms were: Overwhelmed with anxiety, shame/guilt, overthinking, worry), ANXIETY (My Mental Symptoms were: Overwhelmed with anxiety, shame/guilt, overthinking, worry), FATIGUE (exhaustion), DEHYDRATION (major dehydration), EYE IRRITATION (burning eyes) and BEDRIDDEN (bedridden). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COVID-19 (became COVID positive), FEELING GUILTY (My Mental Symptoms were: Overwhelmed with anxiety, shame/guilt, overthinking, worry), ANXIETY (My Mental Symptoms were: Overwhelmed with anxiety, shame/guilt, overthinking, worry), FATIGUE (exhaustion), DEHYDRATION (major dehydration), EYE IRRITATION (burning eyes), BEDRIDDEN (bedridden) and VOMITING (I puke for hours the next day following my second dose,vomiting) outcome was unknown and DRUG INEFFECTIVE (drug ineffective) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jul-2021, Body temperature: high (High) Over 100. On 27-Jul-2021, SARS-CoV-2 test: positive (Positive) positive.         No treatment medication was reported.  This is a case of lack of efficacy of the product. Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. For the event vomiting, based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Events of anxiety, eye irritation, feeling guilty and fatigue  a causal relationship cannot be excluded. But the event COVID-19 is a confounder.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Significant Follow-up received on 04-AUG-2021 including suspect drug batch no, dose details and added concomitant medication.; Sender's Comments: This is a case of lack of efficacy of the product. Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. For the event vomiting, based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Events of anxiety, eye irritation, feeling guilty and fatigue  a causal relationship cannot be excluded. But the event COVID-19 is a confounder.