Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pyrexia, SARS-CoV-2 test
Clinical narrative: Nose is still stuffy; He didn't have a fever by then; COVID-19; Lack of drug effect; Feeling bad; Cold; Something was coming like a fllu; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (Lack of drug effect), FEELING ABNORMAL (Feeling bad), NASOPHARYNGITIS (Cold), INFLUENZA LIKE ILLNESS (Something was coming like a fllu) and NASAL CONGESTION (Nose is still stuffy) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included VITAMIN D NOS, MULTIVITAMINS [VITAMINS NOS] and ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]) for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Oct-2021, the patient experienced FEELING ABNORMAL (Feeling bad), NASOPHARYNGITIS (Cold) and INFLUENZA LIKE ILLNESS (Something was coming like a fllu). On 16-Oct-2021, the patient experienced DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (COVID-19). On an unknown date, the patient experienced NASAL CONGESTION (Nose is still stuffy) and PYREXIA (He didn't have a fever by then). The patient was treated with FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Nose congestion, at an unspecified dose and frequency; AZELASTINE for Adverse event, at an unspecified dose and frequency and Immunotherapy (Monoclonal antibody treatment) for COVID-19. At the time of the report, DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (COVID-19) outcome was unknown, FEELING ABNORMAL (Feeling bad), NASOPHARYNGITIS (Cold) and INFLUENZA LIKE ILLNESS (Something was coming like a fllu) was resolving, NASAL CONGESTION (Nose is still stuffy) had not resolved and PYREXIA (He didn't have a fever by then) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Oct-2021, SARS-CoV-2 test: negative (Negative) Negative. On 16-Oct-2021, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant product includes: Blood pressure medication. Company comment includes-This case concerns a 79-year-old, female patient with relevant medical history of hypertension, who experienced the non-serious adverse event of special interest of COVID-19, non-serious unexpected events of feeling abnormal, nasopharyngitis, influenza like illness, nasal congestion, non-serious expected event of pyrexia. Drug ineffective was considered as an additional event. The event COVID-19 occurred approximately 8 months after the second dose of Spikevax. The events feeling abnormal, nasopharyngitis, influenza like illness, occurred approximately 7 months and 26 days after the second dose of Spikevax. Nasal congestion and pyrexia occurred on an unknown date after the second dose of Spikevax. The rechallenge was assessed as not applicable since the AEs occurred after the second dose. The medical history of hypertension could be a risk factor for the event COVID-19. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.   This case was linked to MOD-2021-366741 (Patient Link). Sender's Comments: This case concerns a 79-year-old, female patient with relevant medical history of hypertension, who experienced the non-serious adverse event of special interest of COVID-19, non-serious unexpected events of feeling abnormal, nasopharyngitis, influenza like illness, nasal congestion, non-serious expected event of pyrexia. Drug ineffective was considered as an additional event. The event COVID-19 occurred approximately 8 months after the second dose of Spikevax. The events feeling abnormal, nasopharyngitis, influenza like illness, occurred approximately 7 months and 26 days after the second dose of Spikevax. Nasal congestion and pyrexia occurred on an unknown date after the second dose of Spikevax. The rechallenge was assessed as not applicable since the AEs occurred after the second dose. The medical history of hypertension could be a risk factor for the event COVID-19. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.