Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drug ineffective, Feeling abnormal, Hot flush
Clinical narrative: sore arm; most immune reaction; hot flushes; lethargic; tested positive for COVID; drug ineffective; minor cold-like symptoms; scratchy throat; a little bit of coughing; runny nose; really intense virusy feeling/mildly virusy; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (minor cold-like symptoms), COVID-19 (tested positive for COVID), THROAT IRRITATION (scratchy throat), COUGH (a little bit of coughing) and RHINORRHOEA (runny nose) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A, 012L20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included TELMISARTAN, ROSUVASTATIN CALCIUM (ROSUVASTATIN CALCIUM GENERIC), DUTASTERIDE, ALFUZOSIN HYDROCHLORIDE, VITAMIN D NOS, ZINC SULFATE (ZINC 220) and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Sep-2021, the patient experienced NASOPHARYNGITIS (minor cold-like symptoms), THROAT IRRITATION (scratchy throat), COUGH (a little bit of coughing), RHINORRHOEA (runny nose) and FEELING ABNORMAL (really intense virusy feeling/mildly virusy). On 23-Sep-2021, the patient experienced COVID-19 (tested positive for COVID) and DRUG INEFFECTIVE (drug ineffective). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), VACCINATION COMPLICATION (most immune reaction), HOT FLUSH (hot flushes) and LETHARGY (lethargic). On 24-Sep-2021, FEELING ABNORMAL (really intense virusy feeling/mildly virusy) had resolved. At the time of the report, NASOPHARYNGITIS (minor cold-like symptoms) had not resolved and COVID-19 (tested positive for COVID), THROAT IRRITATION (scratchy throat), COUGH (a little bit of coughing), RHINORRHOEA (runny nose), PAIN IN EXTREMITY (sore arm), VACCINATION COMPLICATION (most immune reaction), HOT FLUSH (hot flushes), LETHARGY (lethargic) and DRUG INEFFECTIVE (drug ineffective) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Sep-2021, SARS-CoV-2 test: positive (Positive) Tested positive for COVID via a PCR test..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were provided.  it was reported that temperature stayed normal, and the oxygen saturation was normal, as well.  it was also reported that patient got both third Moderna shot and flu shot at the same time in the same arm.  He stated he received a monoclonal antibody infusion this weekend.   This case was linked to MOD-2021-330549, MOD-2021-330550 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: Non-significant follow-up appended; Sender's Comments: This case of Loss Of Effectiveness for this concerns a 71-year-old, male patient with unknown medical history, who experienced the unexpected non-serious events of Covid-19, nasopharyngitis, throat irritation, cough, rhinorrhea and feeling abnormal, pain in extremity, vaccination complication, hot flush and lethargy. The events occurred on the 20 days after receiving the third dose of Moderna mRNA-1273 Vaccine. The rechallenge is not applicable as the events reported were only after third dose. The reporter did not provide the causality assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.