Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dysphemia, Headache, Pruritus, Rash
Clinical narrative: Stuttering when talking; Itchy Stomach; Rashes all over the body and it increase everyday; Headache; he got Covid-19 last year but he cannot recall the specific date; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (he got Covid-19 last year but he cannot recall the specific date), DYSPHEMIA (Stuttering when talking), PRURITUS (Itchy Stomach), RASH (Rashes all over the body and it increase everyday) and HEADACHE (Headache) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A, 0361A21A and 042B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced COVID-19 (he got Covid-19 last year but he cannot recall the specific date). On 10-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPHEMIA (Stuttering when talking), PRURITUS (Itchy Stomach), RASH (Rashes all over the body and it increase everyday) and HEADACHE (Headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash all over, at a dose of UNK UNK, bid. At the time of the report, COVID-19 (he got Covid-19 last year but he cannot recall the specific date), DYSPHEMIA (Stuttering when talking), PRURITUS (Itchy Stomach) and HEADACHE (Headache) outcome was unknown and RASH (Rashes all over the body and it increase everyday) had not resolved.            Weight was asked but unknown. No concomitant drug was reported.  The patient called to report the side effect after he got the booster dose of Moderna vaccine. He did not recall if vaccine was given on his right or left arm. He consulted a physician on the day before  reporting and was given steroid pills and Benadryl tablet took twice a day as treatment for the rashes.  Company Comment: This spontaneous case concerns a 58-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 (he got Covid-19 last year but he cannot recall the specific date) which occurred on an unknown date in 2021 while the first dose of mRNA-1273 was administered on 15-Mar-2021. Inappropriate schedule of product administration was also noted in the case (interval between dose 1 and dose 2 longer than 35 days), Dose interval is 37 days. Non-serious events of Dysphemia, Pruritus, Rash and Headache occurred on the same day after receiving the third dose of mRNA-1273 vaccine. Patient was treated with steroid pills and Benadryl tablet for the rashes. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 58-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 (he got Covid-19 last year but he cannot recall the specific date) which occurred on an unknown date in 2021 while the first dose of mRNA-1273 was administered on 15-Mar-2021. Inappropriate schedule of product administration was also noted in the case (interval between dose 1 and dose 2 longer than 35 days), Dose interval is 37 days. Non-serious events of Dysphemia, Pruritus, Rash and Headache occurred on the same day after receiving the third dose of mRNA-1273 vaccine. Patient was treated with steroid pills and Benadryl tablet for the rashes. The benefit-risk relationship of mRNA-1273 is not affected by this report.