Age: 34.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Anosmia, COVID-19, Dyspnoea, Nasopharyngitis, Pruritus
Clinical narrative: Loss of smell; Cold symptoms; Itching; Shortness of breath; COVID-19 virus test positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 virus test positive), ANOSMIA (Loss of smell), NASOPHARYNGITIS (Cold symptoms), PRURITUS (Itching) and DYSPNOEA (Shortness of breath) in a 34-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On 12-Jul-2022, the patient experienced COVID-19 (COVID-19 virus test positive). On an unknown date, the patient experienced ANOSMIA (Loss of smell), NASOPHARYNGITIS (Cold symptoms), PRURITUS (Itching) and DYSPNOEA (Shortness of breath). At the time of the report, COVID-19 (COVID-19 virus test positive) had not resolved, ANOSMIA (Loss of smell) and NASOPHARYNGITIS (Cold symptoms) outcome was unknown and PRURITUS (Itching) and DYSPNOEA (Shortness of breath) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jul-2022, SARS-CoV-2 test: (Positive) Positive.         Concomitant product use was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  No treatment information was provided.  Company comment: This spontaneous case concerns a 34-year-old female patient, with no reported medical history, who experienced the unexpected non-serious adverse events of special interest COVID-19 (reported as COVID-19 virus test positive) and Anosmia after receiving the 2nd dose of mRNA-1273 vaccine and co-suspect drug Adalimumab. The vaccination date and onset date of event anosmia were not reported, hence latency cannot be assessed. The events were reported along with nasopharyngitis, pruritus, and dyspnoea. Clinical course and treatment details were not reported. The outcome of event COVID-19 was reported as not resolved and anosmia unknown. Patient received 1st dose of mRNA-1273 vaccine (date not reported). Co-suspect drug Adalimumab could be considered as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 34-year-old female patient, with no reported medical history, who experienced the unexpected non-serious adverse events of special interest COVID-19 (reported as COVID-19 virus test positive) and Anosmia after receiving the 2nd dose of mRNA-1273 vaccine and co-suspect drug Adalimumab. The vaccination date and onset date of event anosmia were not reported, hence latency cannot be assessed. The events were reported along with nasopharyngitis, pruritus, and dyspnoea. Clinical course and treatment details were not reported. The outcome of event COVID-19 was reported as not resolved and anosmia unknown. Patient received 1st dose of mRNA-1273 vaccine (date not reported). Co-suspect drug Adalimumab could be considered as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.