Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort, Hyperhidrosis, Pyrexia, Viral test
Clinical narrative: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (significant troubled breathing/short of breath) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced EYE DISCHARGE (eyes really really really began leaking tremendously worse than after getting the 1st and 2nd doses). On 27-Dec-2021, the patient experienced COVID-19 (detected to have Covid-19 after getting a swab test). On an unknown date, the patient experienced DYSPNOEA (significant troubled breathing/short of breath) (seriousness criterion medically significant), FEELING ABNORMAL (Gets windy when he talks/at times fells like dying because he is catching his breath), HYPERHIDROSIS (Sweat), HEAD DISCOMFORT (head feels like 10 pounds heavier), EYELID THICKENING (his eyes was very profuse and thick) and PYREXIA (Fever). At the time of the report, DYSPNOEA (significant troubled breathing/short of breath) and EYE DISCHARGE (eyes really really really began leaking tremendously worse than after getting the 1st and 2nd doses) had not resolved and COVID-19 (detected to have Covid-19 after getting a swab test), FEELING ABNORMAL (Gets windy when he talks/at times fells like dying because he is catching his breath), HYPERHIDROSIS (Sweat), HEAD DISCOMFORT (head feels like 10 pounds heavier), EYELID THICKENING (his eyes was very profuse and thick) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Dec-2021, Viral test: detected to have Covid-19 (Positive) detected to have Covid-19.         Concomitant medication was not reported. The patient was consulted with doctor who is helping getting infusion antibodies, but it is currently not available in their area. The patient was not on any medication at present. Treatment information was not reported. Company comment: This spontaneous case concerns 47-years-old male patient with no medical history provided, who experienced the unexpected serious event Dyspnoea (Medically significant), Unexpected AESI event of COVID19 and unexpected non serious events of Feeling abnormal, Eyelid discharge, Hyperhidrosis, Head discomfort and  Eyelid thickening. The event Eye discharge occurred on same day after third dose of mRNA 1273 vaccine (07 Dec 2021). The event COVID-19 occurred 20 days after the third dose of the mRNA-1273 vaccine and on unknown date patient had Dyspnoea, Feeling abnormal, Hyperhidrosis, Head discomfort, and Eyelid thickening. The outcome  was reported unknown for all events except Dyspnoea and eye discharge which was not resolved. Reportedly Eye discharge was noticed during previous vaccination with mRNA1273 and  COVID-19 test was positive (27 Dec 2021). The benefit-risk relationship of mRNA-1273 in not affected by this report.   This case was linked to MOD-2021-436731, MOD-2021-436262 (Patient Link). Sender's Comments: This spontaneous case concerns 47-years-old male patient with no medical history provided, who experienced the unexpected serious event Dyspnoea (Medically significant), Unexpected AESI event of COVID19 and unexpected non serious events of Feeling abnormal, Eyelid discharge, Hyperhidrosis, Head discomfort, and Eyelid thickening. The event Eye discharge occurred on same day after third dose of mRNA 1273 vaccine (07 Dec 2021). The event COVID-19 occurred 20 days after the third dose of the mRNA-1273 vaccine and on unknown date patient had Dyspnoea, Feeling abnormal, Hyperhidrosis, Head discomfort, and Eyelid thickening. The outcome was reported unknown for all events except Dyspnoea and eye discharge which was not resolved. Reportedly Eye discharge was noticed during previous vaccination with mRNA1273 and COVID-19 test was positive (27 Dec 2021). The benefit-risk relationship of mRNA-1273 in not affected by this report.