Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Feeling unwell; rash; passed out; Disorientation; Chills; Headache; Hives in the whole body; Itching at the injection site; Sore injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure abnormal, Sleep disorder NOS, Herpes NOS since 1980 and Hypothyroidism since 1975. Concomitant products included TELMISARTAN (MICARDIS) for Blood pressure abnormal, VALACYCLOVIR [VALACICLOVIR] for Herpes NOS, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, DIAZEPAM (VALIUM) for Sleep difficult, LEVOTHYROXINE SODIUM (LEVOXYL), ACYCLOVIR [ACICLOVIR], PYRIDOXINE HYDROCHLORIDE (B6) and COLECALCIFEROL (D3) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore injection site). On 27-Jan-2021, the patient experienced URTICARIA (Hives in the whole body), VACCINATION SITE PRURITUS (Itching at the injection site) and HEADACHE (Headache). On 28-Jan-2021, the patient experienced DISORIENTATION (Disorientation) and CHILLS (Chills). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), MALAISE (Feeling unwell) and RASH (rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of Expired; PREDNISONE at a dose of 20 mg; SERTRALINE HYDROCHLORIDE (SERTAC) at an unspecified dose and frequency; FAMOTIDINE (PEPCID [FAMOTIDINE]) at a dose of 2 days and FLUOCINOLONE ACETONIDE (topical) for Rash, at a dose of 2 days. At the time of the report, LOSS OF CONSCIOUSNESS (passed out) and VACCINATION SITE PRURITUS (Itching at the injection site) had resolved and DISORIENTATION (Disorientation), URTICARIA (Hives in the whole body), MALAISE (Feeling unwell), RASH (rash), VACCINATION SITE PAIN (Sore injection site), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: inconclusive (Inconclusive) Inconclusive. On an unknown date, COVID-19: negative (Negative) Negative. On an unknown date, Cognitive test: inconclusive (Inconclusive) Inconclusive. On an unknown date, Computerised tomogram: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was treated with IV steroids , Topical oil for rash .  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: Case updated to Serious , Patient details, conmeds, treatment medications added On 26-May-2021: contact information , Second dose details updated .; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.