Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Computerised tomogram, Inappropriate schedule of product administration, Magnetic resonance imaging, Neck pain
Clinical narrative: blood clot in her brain on the right side artery; She took a home test and had Covid/felt sick with cold symptoms; crick in her neck, pain in her neck; 1st dose on 06 Mar 2021, 2nd dose on 23-Apr-2021; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (blood clot in her brain on the right side artery) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 008E21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder and Sleep disorder. Concomitant products included ZOLPIDEM TARTRATE (AMBIEN) for Sleep disorder NOS, LEVOTHYROXINE for Thyroid disorder.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 06 Mar 2021, 2nd dose on 23-Apr-2021). In May 2022, the patient experienced NECK PAIN (crick in her neck, pain in her neck). On 21-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (She took a home test and had Covid/felt sick with cold symptoms). On an unknown date, the patient experienced THROMBOSIS (blood clot in her brain on the right side artery) (seriousness criterion medically significant). The patient was treated with ACETYLSALICYLIC ACID (BAYER ASPIRIN) at an unspecified dose and frequency. At the time of the report, THROMBOSIS (blood clot in her brain on the right side artery), NECK PAIN (crick in her neck, pain in her neck), COVID-19 (She took a home test and had Covid/felt sick with cold symptoms) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 06 Mar 2021, 2nd dose on 23-Apr-2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2022, SARS-CoV-2 antibody test: positive (Positive) Took a home test and had Covid.. On an unknown date, Computerised tomogram: blood clot in her brain she had a blood clot in her brain on the right side artery. On an unknown date, Magnetic resonance imaging: blood clot in her brain she had a blood clot in her brain on the right side artery.         The patient went on a cruise and upon return on 21 May 2022 and felt sick with cold symptoms. The patient took a home test and had Covid. About 4-5 days into having Covid, the patient had a crick in her neck but ended up going to the ER. After a MRI and CT scan diagnosed with a blood clot in brain on the right side artery.  The patient was put on antibiotics and steroids which was completed and also placed on Bayer 325, a blood thinner, a pain medication and a muscle relaxer to help with the pain in neck. She does not know the names of any of the medications she was put on in the ER.  Company Comment: This spontaneous case concerns a female patient of unknown age with no relevant medical history who experienced the unexpected, serious (medically significant) adverse event of special interest of Thrombosis and non-serious adverse event of special interest of COVID-19 (with a positive SARS-CoV-2 test) which occurred approximately 13 months after receiving the second dose of mRNA-1273 vaccine. Inappropriate schedule of vaccine administered is noted in this case as second dose was administered 48 days after the first dose. Patient developed cold symptoms and tested positive with home COVID-19 test. This was followed by neck pain 5 days after which prompted consultation in the emergency room. A cranial MRI and CT scan were performed which revealed a blood clot involving the right artery of unspecified brain location. Patient was treated with acetylsalicylic acid 325 mg, steroids, and unspecified antibiotics. Diagnosis was not provided but patient is scheduled for a neurologist consultation. Concurrent COVID-19 is a risk factor for thrombosis. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no relevant medical history who experienced the unexpected, serious (medically significant) adverse event of special interest of Thrombosis and non-serious adverse event of special interest of COVID-19 (with a positive SARS-CoV-2 test) which occurred approximately 13 months after receiving the second dose of mRNA-1273 vaccine. Inappropriate schedule of vaccine administered is noted in this case as second dose was administered 48 days after the first dose. Patient developed cold symptoms and tested positive with home COVID-19 test. This was followed by neck pain 5 days after which prompted consultation in the emergency room. A cranial MRI and CT scan were performed which revealed a blood clot involving the right artery of unspecified brain location. Patient was treated with acetylsalicylic acid 325 mg, steroids, and unspecified antibiotics. Diagnosis was not provided but patient is scheduled for a neurologist consultation. Concurrent COVID-19 is a risk factor for thrombosis. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.