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This is VAERS ID 1752930

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First Appeared on 10/15/2021

VAERS ID: 1752930
VAERS Form:2
Age:42.0
Sex:Female
Location:Foreign
Vaccinated:2021-09-06
Onset:2021-09-06
Submitted:0000-00-00
Entered:2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005294 / 1 - / OT

Administered by: Unknown      Purchased by: ??
Symptoms: Blister, Burning sensation, Headache, Hemiparesis, Loss of consciousness, Paralysis

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy (allergy to cat fur); Food allergy (Lamb, snails); Grass allergy; House dust mite allergy; Hypertension; Insulin resistance; Metabolic syndrome (Homocysteine metabolic syndrome); MTHFR gene mutation; Obesity; Thrombophilia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC 'Split Type': ITMODERNATX, INC.MOD20213

Write-up: ; .; .; .; .; .; This case was received via European Medicines Agency (Reference number: IT-MINISAL02-786877) on 23-Sep-2021 and was forwarded to Moderna on 23-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of BLISTER (), HEADACHE (.), BURNING SENSATION (.), LOSS OF CONSCIOUSNESS (.), HEMIPARESIS (.) and PARALYSIS (.) in a 42-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005294) for COVID-19 vaccination. Concurrent medical conditions included Insulin resistance, Hypertension, Thrombophilia, Food allergy (Lamb, snails), Metabolic syndrome (Homocysteine metabolic syndrome), Allergy (allergy to cat fur), Obesity, MTHFR gene mutation, House dust mite allergy and Grass allergy. On 06-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 06-Sep-2021, the patient experienced BLISTER () (seriousness criterion life threatening), HEADACHE (.) (seriousness criterion life threatening), BURNING SENSATION (.) (seriousness criterion life threatening), LOSS OF CONSCIOUSNESS (.) (seriousness criteria medically significant and life threatening), HEMIPARESIS (.) (seriousness criteria medically significant and life threatening) and PARALYSIS (.) (seriousness criteria medically significant and life threatening). At the time of the report, BLISTER (), HEADACHE (.), BURNING SENSATION (.), LOSS OF CONSCIOUSNESS (.), HEMIPARESIS (.) and PARALYSIS (.) had resolved with sequelae. Concomitant product use was not provided. Treatment information was not provided. It was reported that 10 minutes after the first dose of the Moderna vaccine patient had severe burning in head, blisters on face, paralysis on the right side of body, loss of consciousness and a pulsating headache. This case concerns a 42-year-old female patient with relevant medical history of Hypertension, Hypercoagulation, Obesity with Metabolic syndrome and multiple allergies, who experienced the unexpected serious events of Loss of consciousness, Hemiparesis, Paralysis, Blister, Headache, Burning sensation. The events occurred approximately 1 day after the first dose of Moderna COVID-19 Vaccine administration. Blister, Headache and Burning sensation were assessed by the reporting RA as Life threatening; however, the was no clinical evidence provided to justify this seriousness. Therefore, events Blister, Headache and Burning sensation considered as non-serious. The rechallenge was unknown as no information on the second dose available. The benefit-risk relationship is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Translation document received on 27 Sep 2021 contains translated verbatim. On 24-Sep-2021: Follow up information received wherein relevant medical history, updated batch number and new event On 24-Sep-2021: Translation document received on 29 Sep 2021, updated medical history comments, updated translated event verbatim information in I-narrative. On 28-Sep-2021: Follow up information received contains no new information; Sender''s Comments: This case concerns a 42-year-old female patient with relevant medical history of Hypertension, Hypercoagulation, Obesity with Metabolic syndrome and multiple allergies, who experienced the unexpected serious events of Loss of consciousness, Hemiparesis, Paralysis, Blister, Headache, Burning sensation. The events occurred approximately 1 day after the first dose of Moderna COVID-19 Vaccine administration. Blister, Headache and Burning sensation were assessed by the reporting RA as Life threatening; however, the was no clinical evidence provided to justify this seriousness. Therefore, events Blister, Headache and Burning sensation considered as non-serious. The rechallenge was unknown as no information on the second dose available. The benefit-risk relationship is not affected by this report.

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