Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Fatigue, Inappropriate schedule of product administration, Nasopharyngitis, Pyrexia
Clinical narrative: Loss of smell; Cold symptoms; Fatigue; Fever; 1st dose-01-MAR-2021,Dose 2-01-JUN-2021; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Loss of smell), NASOPHARYNGITIS (Cold symptoms), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose-01-MAR-2021,Dose 2-01-JUN-2021), FATIGUE (Fatigue) and PYREXIA (Fever) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    The patient's past medical history included COVID-19. Concurrent medical conditions included Plaque psoriasis.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 01-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose-01-MAR-2021,Dose 2-01-JUN-2021). On an unknown date, the patient experienced ANOSMIA (Loss of smell), NASOPHARYNGITIS (Cold symptoms), FATIGUE (Fatigue) and PYREXIA (Fever). At the time of the report, ANOSMIA (Loss of smell), NASOPHARYNGITIS (Cold symptoms), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose-01-MAR-2021,Dose 2-01-JUN-2021), FATIGUE (Fatigue) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2021, SARS-CoV-2 test: (Positive) Positive.         Concomitant products were not provided. Treatment medication were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 01 Jan 2021, the patient experienced COVID-19 postive. On 05 jan 2021, the covid 19 postive resolved. On 22 feb 2021, the patient experienced psoriasis breakouts which is not recovered. Patient stated Skyrizi resulted originally cleared up over a year ago when he began treatment, after the first 2 initial treatment patient noticed his skin clear up. After the first two treatments patient hasn't noticed any improvement with psoriasis. Patient mentioned skin remaining discolored and due to breakouts. Patient applied topical cream on leg when he wore shorts.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment-This spontaneous case concerns a male patient aged 49 years with relevant past medical history of Covid -19 reported, who experienced the unexpected non serious AESI event of Anosmia on unknown date in the context of mRNA-1273 vaccination. Inappropriate schedule of product administration was noted as patient had received 1st and 2nd dose of same vaccine at an interval of 3 months and a booster dose 6 months later. Patient also had non serious events of Nasopharyngitis, fatigue and pyrexia. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the event was not known at the time of report. Relevant past medical history could be confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement; Sender's Comments: This spontaneous case concerns a male patient aged 49 years with relevant past medical history of Covid -19 reported, who experienced the unexpected non serious AESI event of Anosmia on unknown date in the context of mRNA-1273 vaccination. Inappropriate schedule of product administration was noted as patient had received 1st and 2nd dose of same vaccine at an interval of 3 months and a booster dose 6 months later. Patient also had non serious events of Nasopharyngitis, fatigue and pyrexia. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the event was not known at the time of report. Relevant past medical history could be confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement