Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Gastrointestinal pain, Headache, Nausea
Clinical narrative: a blood vessel burst in her right eye; intestinal pain; loose stools; swollen left arm that was hot; light sensitivity like someone piercing eye with hot poker; swelling of her right eyelid; She has deterioration in her spine & lower back due to her history of lupus & that acted up; brain fog; then was sore; fatigue; joint aches; nausea; headache; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of EYE HAEMORRHAGE (a blood vessel burst in her right eye), GASTROINTESTINAL PAIN (intestinal pain), DIARRHOEA (loose stools), PERIPHERAL SWELLING (swollen left arm that was hot) and PHOTOPHOBIA (light sensitivity like someone piercing eye with hot poker) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Systemic lupus erythematosis since 1979.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced DIZZINESS (dizziness) and HEADACHE (headache). On an unknown date, the patient experienced EYE HAEMORRHAGE (a blood vessel burst in her right eye), GASTROINTESTINAL PAIN (intestinal pain), DIARRHOEA (loose stools), PERIPHERAL SWELLING (swollen left arm that was hot), PHOTOPHOBIA (light sensitivity like someone piercing eye with hot poker), SWELLING OF EYELID (swelling of her right eyelid), CONDITION AGGRAVATED (She has deterioration in her spine & lower back due to her history of lupus & that acted up), FEELING ABNORMAL (brain fog), PAIN IN EXTREMITY (then was sore), FATIGUE (fatigue), ARTHRALGIA (joint aches) and NAUSEA (nausea). At the time of the report, EYE HAEMORRHAGE (a blood vessel burst in her right eye), GASTROINTESTINAL PAIN (intestinal pain), DIARRHOEA (loose stools), PERIPHERAL SWELLING (swollen left arm that was hot), PHOTOPHOBIA (light sensitivity like someone piercing eye with hot poker), SWELLING OF EYELID (swelling of her right eyelid), CONDITION AGGRAVATED (She has deterioration in her spine & lower back due to her history of lupus & that acted up), FEELING ABNORMAL (brain fog), PAIN IN EXTREMITY (then was sore), FATIGUE (fatigue), ARTHRALGIA (joint aches), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown and DIZZINESS (dizziness) had resolved.            Patient had significant reactions involving a # of systems that lasted 16 days before she began a one week course of Prednisone.  The prednisone quieted everything down starting the day patient first took it on day 17 after her 3rd dose. By the next day her symptoms had mostly resolved.  Most of her symptoms are part of the lupus but the vaccine made them worse.  Company Comment: This case concerns a 73-year-old female patient with  relevant medical history of Systemic lupus erythematosis, who experienced unexpected events of dizziness, eye haemorrhage, gastrointestinal pain, diarrhoea, peripheral swelling, photophobia, swelling of eyelid, condition aggravated, feeling abnormal and pain in extremity. The event dizziness occurred approximately 1 day after the third dose of mRNA-1273. The other events occurred on an unknown date after the third dose of mRNA-1273. The rechallenge was not applicable as no additional dosing is expected. Medical history of Systemic lupus erythematosis remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. The event eye haemorrhage is marked serious by the auto-seriousness tool.  Case downgraded to non-serious due to the lack of evidence of seriousness from a clinical or regulatory standpoint, and reporter assessed the case as non-serious.   This case was linked to MOD-2021-333655, MOD-2021-333670 (Patient Link).; Sender's Comments: This case concerns a 73-year-old female patient with  relevant medical history of Systemic lupus erythematosis, who experienced unexpected events of dizziness, eye haemorrhage, gastrointestinal pain, diarrhoea, peripheral swelling, photophobia, swelling of eyelid, condition aggravated, feeling abnormal and pain in extremity. The event dizziness occurred approximately 1 day after the third dose of mRNA-1273. The other events occurred on an unknown date after the third dose of mRNA-1273. The rechallenge was not applicable as no additional dosing is expected. Medical history of Systemic lupus erythematosis remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. The event eye haemorrhage is marked serious by the auto-seriousness tool.  Case downgraded to non-serious due to the lack of evidence of seriousness from a clinical or regulatory standpoint, and reporter assessed the case as non-serious.