Your Health. Your Family. Your Choice.
|History of Changes from the VAERS Wayback Machine|
|Vaccination / Manufacturer||Lot / Dose||Site / Route|
|COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA||3002180 / 1||- / OT|
Administered by: Unknown Purchased by: ??
Symptoms: Anaphylactic reaction, Body temperature, Heart rate, Oxygen saturation, Respiratory rate, Blood pressure measurement
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)? No
Hospitalized? Yes, days:
Write-up: Anaphylactic reaction; This regulatory authority case was reported by a physician and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 65-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002180) for COVID-19 vaccination. Concurrent medical conditions included Pancreatic carcinoma, Diabetes mellitus and Asthma. On 01-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 01-Jun-2021 at 7:31 PM, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criteria hospitalization and medically significant). The patient was hospitalized until 02-Jun-2021 due to ANAPHYLACTIC REACTION. The patient was treated with EPINEPHRINE for Anaphylactic reaction, at a dose of 0.3 milligram. On 02-Jun-2021, ANAPHYLACTIC REACTION (Anaphylactic reaction) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jun-2021, Blood pressure measurement: 88/52 (Low) Test Result:88/52 mm[Hg], 82/51 (Low) Test Result:82/51 mm[Hg], 88/51 (Low) Test Result:88/51 mm[Hg] and 108/53 (Low) Test Result:108/53 mm[Hg]. On 02-Jun-2021, Heart rate: 79 (normal) Test Result:79. On 02-Jun-2021, Oxygen saturation: 97 (normal) Normal and 99 (normal) Normal. On 02-Jun-2021, Respiratory rate: 24 (Inconclusive) Test Result:24. On an unknown date, Blood pressure measurement: 130 (Inconclusive) 130. On an unknown date, Body temperature: 35.9 (Low) Decreased. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered ANAPHYLACTIC REACTION (Anaphylactic reaction) to be possibly related. No concomitant medications were reported. Other treatment medications provided by the reporter included Drip infusion of normal saline solution This case, initially reported to the Moderna adverse reaction reporting site by a physician, was received by the regulatory authority. On an unknown date, body temperature before vaccination: 35.9 degrees Celsius. On 01-JUN-2021, at 19:12, the patient received the 1st dose of the vaccine. At 19:31, anaphylaxis developed. The event developed 19 minutes after the vaccination, was not sudden onset, and was rapidly progressive. There was no skin or mucosal symptom. There was a cardiovascular symptom (hypotension). There was no respiratory symptom. There was no gastrointestinal symptom. When the patient walked independently to a toilet, the patient felt poorly with cold sweat. The consciousness was clear. The patient moved to a treatment room. BP was 88/52 mmHg. SpO2 was 97%. There was no abnormal respiratory sound. There was no skin eruption. At 19:45, the patients feeling improved with bed rest, but BP was 82/51 mmHg and the patient originally had blood pressure of 130 mmHg. Thus, a diagnosis of shock vital was made. Intramuscular injection of epinephrine 0.3 mg was performed. Drip infusion of normal saline solution was started. At 19:55, BP was 88/51 mmHg. Since hypotension persisted, transportation to another hospital was decided. At 20:25, before transportation, BP was 108/53 mmHg, HR 79, SpO2 99%, and RR 24. On 02-JUN-2021, the patient was discharged from the hospital. The outcome of anaphylaxis was resolved. Follow-up investigation will be made. Company Comment: Based on the 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.; Sender''s Comments: Based on the 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.
Copyright © 2021 National Vaccine Information Center. All rights reserved.
21525 Ridgetop Circle, Suite 100, Sterling, VA 20166