Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Drug ineffective, Influenza like illness, Myalgia
Clinical narrative: Tested positive for COVID, although antibody test then came out negative; Lack of drug effect; Fever; Chills; Body aches / pain; 2 days of flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (2 days of flu like symptoms), COVID-19 (Tested positive for COVID, although antibody test then came out negative), DRUG INEFFECTIVE (Lack of drug effect), PYREXIA (Fever) and CHILLS (Chills) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Insomnia. Concomitant products included ESZOPICLONE for Insomnia, ROSUVASTATIN, PIOGLITAZONE and PANTOPRAZOLE for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (2 days of flu like symptoms). On 12-Feb-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches / pain). On 17-Mar-2021, the patient experienced COVID-19 (Tested positive for COVID, although antibody test then came out negative). 17-Mar-2021, the patient experienced DRUG INEFFECTIVE (Lack of drug effect). On 13-Feb-2021, PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches / pain) had resolved. On 14-Feb-2021, INFLUENZA LIKE ILLNESS (2 days of flu like symptoms) had resolved. On 17-Mar-2021, DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown. At the time of the report, COVID-19 (Tested positive for COVID, although antibody test then came out negative) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, SARS-CoV-2 test: positive (Positive) tested positive. In 2021, SARS-CoV-2 antibody test: negative (Negative) Antibody test was negative..         Concomitant medication included rosuvastatin for cholesterol.  No treatment medication was reported.  Based on the mechanism of action of mRNA-1273, the event (Covid-19) is assessed as unlikely related to mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of other events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2021: Upon internal review on 06-Aug-2021, event of Lack of drug effect was added. Route of administration of the suspect product was also updated. On 12-May-2021: Additional information received on 12-May-2021 was updated with patient information, patient relevant medical history, concomitant medications, start date and outcome of events fever, chills and body ache. Causality for the events fever, chills and body ache was updated. On 16-Jul-2021: Follow up information was received on 16-Jul-2021 contains no new information.; Sender's Comments: Based on the mechanism of action of mRNA-1273, the event (Covid-19) is assessed as unlikely related to mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of other events, a causal relationship cannot be excluded.