Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Feeling abnormal, SARS-CoV-2 antibody test
Clinical narrative: Tested positive for Covid-19; Tested positive for Covid-19; Felt bad all the way around; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (Tested positive for Covid-19), FEELING ABNORMAL (Felt bad all the way around) and COVID-19 (Tested positive for Covid-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067H21A, 036B21A and 038A21A) for COVID-19 vaccination.  Patient's allergies were unknown. History related to adverse events and both Acute and Chronic illnesses at the time of vaccination was unknown. It was unknown, if patient received any other vaccines within 1 month prior to Moderna COVID-19 vaccine.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 06-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING ABNORMAL (Felt bad all the way around). On 08-May-2022, the patient experienced DRUG INEFFECTIVE (Tested positive for Covid-19) and COVID-19 (Tested positive for Covid-19). At the time of the report, DRUG INEFFECTIVE (Tested positive for Covid-19) outcome was unknown, FEELING ABNORMAL (Felt bad all the way around) had resolved and COVID-19 (Tested positive for Covid-19) had not resolved.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-May-2022, SARS-CoV-2 antibody test: positive (Positive) Positive.  No concomitant medications were reported. In 2022, patient recovered from event felt bad all the way around. Patient did not seek medical care for event felt bad however seek medical care for event COVID-19, sore throat and cough. Patient did not want to get the 2nd booster dose because she had bad reaction to the 2nd shot and the booster. No treatment medication was reported.  Company Comment: This spontaneous case concerns a female patient of an unknown age, with no relevant medical history, who experienced the unexpected events of COVID-19 (AESI)  and Drug ineffective, approximately 4 months after receiving the third dose of mRNA-1273 Vaccine. The outcome of the events was reported as not resolved. The patient also experienced Feeling abnormal a day after the third dose of the vaccine that is now resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.  This case was linked to MOD-2022-561910, MOD-2022-561889 (Patient Link).  Reporter did not allow further contact  Most recent FOLLOW-UP information incorporated above includes: On 09-May-2022: Follow up contains no new information.; Sender's Comments: This spontaneous case concerns a female patient of an unknown age, with no relevant medical history, who experienced the unexpected events of COVID-19 (AESI)  and Drug ineffective, approximately 4 months after receiving the third dose of mRNA-1273 Vaccine. The outcome of the events was reported as not resolved. The patient also experienced Feeling abnormal a day after the third dose of the vaccine that is now resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.