Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Foot pain; Feels so bad Feels terrible; Tested positive on 14Mar2022; Patient got covid Tested positive for covid on 14Mar2022; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), PAIN IN EXTREMITY (Foot pain), FEELING ABNORMAL (Feels so bad Feels terrible), DRUG INEFFECTIVE (Tested positive on 14Mar2022) and COVID-19 (Patient got covid Tested positive for covid on 14Mar2022) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A, D10M20-A and 025L201A/4) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus (Since 10 years old). Concomitant products included INSULIN for Type 1 diabetes mellitus.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Dec-2020, the patient experienced RHINORRHOEA (Runny nose). On 14-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Patient got covid Tested positive for covid on 14Mar2022). On an unknown date, the patient experienced PAIN IN EXTREMITY (Foot pain), FEELING ABNORMAL (Feels so bad Feels terrible) and DRUG INEFFECTIVE (Tested positive on 14Mar2022). The patient was treated with TRIAMCINOLONE ACETONIDE (NASACORT) on 14-Mar-2022 at an unspecified dose and frequency and MOLNUPIRAVIR on 14-Mar-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, RHINORRHOEA (Runny nose) had not resolved and PAIN IN EXTREMITY (Foot pain), FEELING ABNORMAL (Feels so bad Feels terrible), DRUG INEFFECTIVE (Tested positive on 14Mar2022) and COVID-19 (Patient got covid Tested positive for covid on 14Mar2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2022, SARS-CoV-2 test: positive (Positive) Positive.         Patient stated that her nose has ran since the day of the 1st dose but said it could be allergies.The patient stated that is has been going on and on. Nasacort - the steroid was given to decrease secretions.  Company Comment: This spontaneous case concerns a 52-year-old, female patient with no relevant medical history reported, who experienced the unexpected,non-serious Adverse Event of Special Interest of COVID-19, which occurred 4 months and 2 days after the booster dose of mRNA-1273 vaccine administration. Additionally, drug ineffective was also reported. The diagnosis of COVID-19 was supported by SARS-CoV-2 test which was positive. The patient was treated with triamcinolone (Nasacort) and molnupiravir. The ongoing COVID-19 pandemic is a confounder for the event. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-513468, MOD-2021-214960 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2022: Follow up received included. Non significant information (quality complaint number); Sender's Comments: This spontaneous case concerns a 52-year-old, female patient with no relevant medical history reported, who experienced the unexpected,non-serious Adverse Event of Special Interest of COVID-19, which occurred 4 months and 2 days after the booster dose of mRNA-1273 vaccine administration. Additionally, drug ineffective was also reported. The diagnosis of COVID-19 was supported by SARS-CoV-2 test which was positive. The patient was treated with triamcinolone (Nasacort) and molnupiravir. The ongoing COVID-19 pandemic is a confounder for the event. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.