Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Presyncope, Pruritus, Retinal haemorrhage, Rhinorrhoea
Clinical narrative: Double vision; Confusion; Dry mouth; All over body itchiness; My body was filled with sores on my breasts, armpits and back; my blood pressure was high; Neck rigidity; Retinal Hemorrhage; Blood shot eye in right eye; Headache; I thought I was going to pass out; I started shaking; Palpitations; Half of my head (the right) felt a little cold; The vein in my head was swollen; the half part of my body on the right became very stiff; it started to hurt; my mouth started tingling; tachycardia; Right eye started to water; On the left side, in the groin, I had a numbing sensation; My tongue also got dry; runny nose; Half of my head (the right) felt a little cold; Chills; nausea; Extreme fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RETINAL HAEMORRHAGE (Retinal Hemorrhage) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergy to Tramadol). Concomitant products included TRAMADOL.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced LACRIMATION INCREASED (Right eye started to water), PALPITATIONS (Palpitations), HYPOAESTHESIA (On the left side, in the groin, I had a numbing sensation), TONGUE DRY (My tongue also got dry), RHINORRHOEA (runny nose), NASOPHARYNGITIS (Half of my head (the right) felt a little cold), HEAD DISCOMFORT (Half of my head (the right) felt a little cold), VEIN DISORDER (The vein in my head was swollen), MUSCULOSKELETAL STIFFNESS (the half part of my body on the right became very stiff), PAIN (it started to hurt), PARAESTHESIA ORAL (my mouth started tingling), TACHYCARDIA (tachycardia), CHILLS (Chills), NAUSEA (nausea) and FATIGUE (Extreme fatigue). On 27-Feb-2021, the patient experienced PRESYNCOPE (I thought I was going to pass out) and TREMOR (I started shaking). On 11-Mar-2021, the patient experienced RETINAL HAEMORRHAGE (Retinal Hemorrhage) (seriousness criterion medically significant), OCULAR HYPERAEMIA (Blood shot eye in right eye), NUCHAL RIGIDITY (Neck rigidity) and HEADACHE (Headache). On 12-Mar-2021, the patient experienced HYPERTENSION (my blood pressure was high). On an unknown date, the patient experienced DIPLOPIA (Double vision), CONFUSIONAL STATE (Confusion), DRY MOUTH (Dry mouth), PRURITUS (All over body itchiness) and MYALGIA (My body was filled with sores on my breasts, armpits and back). At the time of the report, RETINAL HAEMORRHAGE (Retinal Hemorrhage), OCULAR HYPERAEMIA (Blood shot eye in right eye), LACRIMATION INCREASED (Right eye started to water), DIPLOPIA (Double vision), NUCHAL RIGIDITY (Neck rigidity), HYPERTENSION (my blood pressure was high), PALPITATIONS (Palpitations), PRESYNCOPE (I thought I was going to pass out), CONFUSIONAL STATE (Confusion), HYPOAESTHESIA (On the left side, in the groin, I had a numbing sensation), TONGUE DRY (My tongue also got dry), RHINORRHOEA (runny nose), NASOPHARYNGITIS (Half of my head (the right) felt a little cold), DRY MOUTH (Dry mouth), HEAD DISCOMFORT (Half of my head (the right) felt a little cold), VEIN DISORDER (The vein in my head was swollen), MUSCULOSKELETAL STIFFNESS (the half part of my body on the right became very stiff), PAIN (it started to hurt), PARAESTHESIA ORAL (my mouth started tingling), TACHYCARDIA (tachycardia), PRURITUS (All over body itchiness), TREMOR (I started shaking), HEADACHE (Headache), MYALGIA (My body was filled with sores on my breasts, armpits and back), CHILLS (Chills), NAUSEA (nausea) and FATIGUE (Extreme fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Blood glucose: low (Low) Dropped to 60. On 27-Feb-2021, Blood pressure measurement: high (High) 174/90 mm Hg..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Events retinal hemorrhage, diplopia, nuchal rigidity, palpitations, headache, etc were added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.