Sex: U
Vaccine: COVID19, COVID19, UNK
Symptoms: Chills, Fatigue, Headache, Injection site pain, Pain
Clinical narrative: retinal tear; Severe Body aches; severe headaches like a hot poker piercing debilitating headache like patient head was going to fall off; patient got the chills; patient  was very tired; Very sore left injection site arm; This spontaneous case was reported by a patient and describes the occurrence of RETINAL TEAR (retinal tear) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products POVIDONE-IODINE (COVIDON) for an unknown indication and RETINALDEHYD for an unknown indication.    The patient's past medical history included Retinal tear.   On 28-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started POVIDONE-IODINE (COVIDON) (unknown route) at an unspecified dose and RETINALDEHYD (unknown route) at an unspecified dose. On 28-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INJECTION SITE PAIN (Very sore left injection site arm). On 29-Oct-2021, the patient experienced PAIN (Severe Body aches), HEADACHE (severe headaches like a hot poker piercing debilitating headache like patient head was going to fall off), CHILLS (patient got the chills) and FATIGUE (patient  was very tired). On 28-Jan-2023, the patient experienced RETINAL TEAR (retinal tear) (seriousness criterion medically significant). At the time of the report, RETINAL TEAR (retinal tear), PAIN (Severe Body aches), INJECTION SITE PAIN (Very sore left injection site arm), HEADACHE (severe headaches like a hot poker piercing debilitating headache like patient head was going to fall off), CHILLS (patient got the chills) and FATIGUE (patient  was very tired) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2023, SARS-CoV-2 antibody test: did not return with antibodies. On an unknown date, SARS-CoV-2 antibody test: 5 of the tests returned with antibodies.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on 28-Oct-2021.       It was unknown if the patient received any vaccine in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Company comment- This spontaneous case concerns an adult patient of unknown gender with relevant medical history of retinal tear, who experienced the unexpected serious (medically significant) event of retinal tear approximately 1 year and 3 months after a dose of mRNA-1273 vaccine, given as a first dose of COVID-19 vaccine schedule, was administered. The patient had several severe adverse reactions after vaccination with a very sore left injection site arm, severe body aches, severe headaches, tiredness, and chills. Then the patient started to feel better. One year after patient had a retinal tear and had laser surgery. Retinal tear was assessed as not related, considering lack of temporal association and the medical history of retinal tear, that remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  On 28-Oct-2021, patient had a minor sore left arm. On 29-Oct-2021, patient had several severe adverse reactions. Very sore left injection site arm. Severe Body aches, severe headaches like a hot poker piercing debilitating headache like my head was going to fall off. Patient was very tired. Patient got the chills, It was one solid day of Pure . Patient felt like if an elderly person got this shot that they may not have survived the side effects of the Moderna Covid-19 vaccine. On 30-Oct-2021 patient started to feel better. The patient did not receive any additional Moderna Covid-19 vaccines after his first dose. On the weekend of 28-Jan-2023, patient had retinal tear. On 01-Feb-2023, Patient had laser surgery on Wednesday. The patient has had 6 antibodies for SARS Co-V 2 antibodies. 5 of the tests returned with antibodies. The test in Apr-2023 did not return with antibodies.  On 03-Aug-2023, patient seems to had a flight of ideas on the phone jumping fro   This case was linked to US-MODERNATX, INC.-MOD-2023-735503 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735503:Same reporter