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|History of Changes from the VAERS Wayback Machine|
|Vaccination / Manufacturer||Lot / Dose||Site / Route|
|COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA||3002912 / 1||RA / OT|
Administered by: Unknown Purchased by: ??
Symptoms: Body temperature, Chills, Concussion, Dizziness, Fall, Headache, Loss of consciousness, Pain in extremity, Pyrexia, Syncope
Life Threatening? No
Birth Defect? No
Permanent Disability? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? Yes
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Diagnostic Lab Data: Test Date: 20210604; Test Name: Body temperature; Result Unstructured Data: Increased; Test Date: 20210605; Test Name: Body temperature; Result Unstructured Data: Increased
CDC 'Split Type': CHMODERNATX, INC.MOD20212
Write-up: suddenly fainted; lost consciousness for a few seconds; Fall; slight concussion; Light pain in the arm; Dizziness; Chills; Headache; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (suddenly fainted) and LOSS OF CONSCIOUSNESS (lost consciousness for a few seconds) in a 26-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3002912) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included COVID-19 in October 2020. On 04-Jun-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced SYNCOPE (suddenly fainted) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (lost consciousness for a few seconds) (seriousness criterion medically significant), FALL (Fall), CONCUSSION (slight concussion), PAIN IN EXTREMITY (Light pain in the arm), DIZZINESS (Dizziness), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever). The patient was treated with PARACETAMOL from 04-Jun-2021 to 06-Jun-2021 for Fever, at a dose of 3 dosage form. On 04-Jun-2021, SYNCOPE (suddenly fainted) and LOSS OF CONSCIOUSNESS (lost consciousness for a few seconds) had resolved. On 07-Jun-2021, PYREXIA (Fever) had resolved. At the time of the report, FALL (Fall), CONCUSSION (slight concussion) and CHILLS (Chills) outcome was unknown and PAIN IN EXTREMITY (Light pain in the arm), DIZZINESS (Dizziness) and HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jun-2021, Body temperature: 38 degree Celsius (High) Increased. On 05-Jun-2021, Body temperature: 37-38 degree Celsius (High) Increased. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown) was unknown. Patient states that he does not take any other medications and have no pre-existing medical conditions except that he wear glasses. Concomitant medications were not provided. Patient received the vaccine in the morning as an injection to the right arm, since the left arm is his dominant arm. patient was feeling good during the day, no fever, just light pain in the arm. In the evening, the patient visited his parent''s in-law and watched TV on the couch. the patient got up from the couch, walked about 10 meters and suddenly fainted. (patient was found half a meter away from the doorframe), he had lost consciousness for a few seconds, their relatives found the patient on the floor. (patient did not realize what was happening around him until he suddenly regained consciousness) then the patient had a fever (38 degree) and chills. patient waited for a while to feel better and then went to the emergency room on the same night. In the hospital, patient was diagnosed with slight concussion due to the fall. No treatment was prescribed. It was reported that the patient continued to have a light fever through Saturday (05-Jun-2021) and Sunday (06-Jun-2021) at around 37-38 Degree, so the patient took 1 tablet of paracetamol on Sunday evening. On 07-Jun-2021, patient fever is gone and there is still some feeling of dizziness, headache and light pain in the arm. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. affiliate comment: This spontaneous report was received from a 26-year-old male consumer who received the first dose of Moderna''s COVID-19 Vaccine (mRNA1273) on 04-JUN-2021 in his right arm (Batch number: 3002912, exp date: unknown) for prophylaxis of COVID-19 infection. The reporter felt well during the day after the vaccination but experienced a slight pain in the vaccination arm which did not have any impact as his dominant arm was the left one. However, on the same day in the evening, when he was visiting his family and was watching TV, he got up from the couch, walked about 10 meters and suddenly fainted (verbatim: I found myself half a meter away from the doorframe). They had lost consciousness for a few seconds, his relatives found him on the floor (verbatim: I did not realize what was happening around me until I suddenly regained consciousness). After that, the reporter experienced fever (38?) and chills. He presented himself on the same evening to the local hospital for investigations in emergency. In the hospital, a slight concussion due to the fall was diagnosed, no treatment was prescribed. He applied self-treatment with 2 tablets of paracetamol for the reported fever. Over the next 2 days, the reporter continued to experience "slight fever" throughout Saturday, 05-JUN-2021 and Sunday, 06-JUN-2021 up to 37?-38?C; he applied an additional tablet of paracetamol on Sunday evening and the fever resolved by the next day 07-JUN-2021. At the moment of reporting on 07-JUN-2021, the fever was resolved but dizziness, headache and also a slight pain in the arm were still ongoing. The medical history did not include any relevant condition or comorbidity (except that the reporter had been wearing glasses) and no concomitant medication was used at the time of vaccination. The company assessed the case as serious. Company''s assessment: Based on 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. Local assessment: Vaccination arm pain (onset latency: on the same day after the vaccination with the first dose, grade not reported ? described by the reporter as mild, unilateral, ipsilateral to the vaccination arm without impact on activities as the vaccination arm was the non-dominant one) [unlabeled / no additional risk minimization measures (aRMMs) necessary; episode of fainting with transitory loss of consciousness and fall leading to mild concussion (onset latency: in the evening of the vaccination day; assumed resolved by the moment of reporting with residual dizziness and headache; other physical signs or symptoms possibly associated with the reported concussion were not specified, possible late-onset symptoms following concussion not known at the moment of reporting; no symptoms which may have triggered the patient to get up from the coach were reported; possibly associated febrile state) [unlabeled / no aRMMs necessary for the general population; the patient was consulted in emergency by hospital physician; we assume vasovagal effects which did not require inpatient treatment, but specific tests to rule out other causes for fainting in this apparently healthy young man must be confirmed; the hospital report was not provided]; fever (up to 38?C) (onset latency: in the evening of the vaccination day, following fainting, resolved with paracetamol treatment over the next 2 days) [labeled / no aRMMs necessary for the general population; chills (onset latency: in the evening of the vaccination day, following fainting, resolved by the time of reporting) [labeled / no aRMMs necessary for the general population; headache and dizziness (onset latency: assumed after the reported fainting with concussion, grade not reported, ongoing at the time of reporting) [unlabeled in the context of fainting but headache alone is covered necessary for the general population. Action taken with the Moderna product in response to the reported events was not reported. The events reported on 07-JUN-2021 are assessed as possibly related to the vaccine, confounded by the ophthalmological condition and/or external visual triggers; pupillary pathways in triggering the event of fainting cannot be ruled out. The long-term outcome of the event is not known.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
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