Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Influenza like illness, Oropharyngeal pain, Pain, Polymerase chain reaction
Clinical narrative: Tinnitus; Cystitis; COVID-19; Lack of drug effect; Runny nose; Headache; fatigue; Sore throat; Viral illness; Body ache; Headache; Flu-like symptoms; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (COVID-19), DRUG INEFFECTIVE (Lack of drug effect), CYSTITIS (Cystitis), INFLUENZA LIKE ILLNESS (Flu-like symptoms) and TINNITUS (Tinnitus) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL ALLERGY/COLD) for Seasonal allergy, MONASCUS PURPUREUS, NICOTINAMIDE, PHYTOSTEROLS NOS (RED YEAST RICE WITH PLANT STEROLS) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN (Body ache) and the first episode of HEADACHE (Headache). On 07-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OROPHARYNGEAL PAIN (Sore throat). On 10-Mar-2021, the patient experienced RHINORRHOEA (Runny nose) and the second episode of HEADACHE (Headache). 10-Mar-2021, the patient experienced FATIGUE (fatigue). In March 2021, the patient experienced ILLNESS (Viral illness). On 16-Mar-2021, the patient experienced COVID-19 (COVID-19). 16-Mar-2021, the patient experienced DRUG INEFFECTIVE (Lack of drug effect). On 17-Mar-2021, the patient experienced CYSTITIS (Cystitis). On an unknown date, the patient experienced TINNITUS (Tinnitus). On 27-Jan-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms) and PAIN (Body ache) had resolved. On 16-Mar-2021, DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown. On 19-Mar-2021, RHINORRHOEA (Runny nose) and the last episode of HEADACHE (Headache) had resolved. On 31-Mar-2021, CYSTITIS (Cystitis) had resolved. At the time of the report, COVID-19 (COVID-19), OROPHARYNGEAL PAIN (Sore throat), ILLNESS (Viral illness) and FATIGUE (fatigue) had resolved and TINNITUS (Tinnitus) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Polymerase chain reaction: positive (Positive) SARS-CoV-2 test positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information reported included antibiotics for Cystitis.  This is a case of lack of efficacy for mRNA-1273. Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as not applicable. Based on the current available information and temporal association between the use of the product and the start date of the other events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-049931 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Significant follow up added and added events; Sender's Comments: This is a case of lack of efficacy for mRNA-1273. Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as not applicable. Based on the current available information and temporal association between the use of the product and the start date of the other events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-049931:crosslink 1st dose