Age: 56.0
Sex: M
Vaccine: COVID19-2, COVID19-2, COVID19
Symptoms: Loss of consciousness, Nasopharyngitis, SARS-CoV-2 test negative, Suspected COVID-19
Clinical narrative: lost Facial Hair as well; bad cold; some thinning of his hair after the first booster dose; Patient reports adverse Reactions of a sore left injection site arm.; Suspected COVID-19; passed out; felt light headed; first Moderna Covid 19 vaccine primary series on January 23,2021 and second dose on March 2, 2021; This spontaneous case was reported by a pharmacist and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 032L20A and 013A21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included ATORVASTATIN, TADALAFIL, FISH OIL, VITAMINS NOS (MVI [VITAMINS NOS]), BIOTIN and TADALAFIL (CIALIS) for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first Moderna Covid 19 vaccine primary series on January 23,2021 and second dose on March 2, 2021). On 03-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant) and DIZZINESS (felt light headed). On an unknown date, the patient experienced HYPOTRICHOSIS (lost Facial Hair as well), NASOPHARYNGITIS (bad cold), ALOPECIA (some thinning of his hair after the first booster dose), VACCINATION SITE PAIN (Patient reports adverse Reactions of a sore left injection site arm.) and SUSPECTED COVID-19 (Suspected COVID-19). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), NASOPHARYNGITIS (bad cold), DIZZINESS (felt light headed), VACCINATION SITE PAIN (Patient reports adverse Reactions of a sore left injection site arm.), SUSPECTED COVID-19 (Suspected COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first Moderna Covid 19 vaccine primary series on January 23,2021 and second dose on March 2, 2021) outcome was unknown, HYPOTRICHOSIS (lost Facial Hair as well) had not resolved and ALOPECIA (some thinning of his hair after the first booster dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, SARS-CoV-2 test: Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient also took antioxidant combination for unknown indication. Patient also suspected a possibility of a Covid-19 infection after his first booster dose at the end of November 2021. Patient tested for COVID-19 and it came back negative however patient thought that he may have tested too early and he did not test again as he thought that it was a bad cold. On 14-Oct-2022, the patient received MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) additional booster dose (Lot number 053D22A) in the left arm. Treatment details was not reported by the reporter. Company comment: This spontaneous case concerns a 56-year-old male patient, with no medical history reported, who experienced the unexpected, serious (medically significant) events of LOSS OF CONSCIOUSNESS on the following day of the second dose of mRNA-1273 vaccine, among other non-serious events. He woke up on the following day of vaccination feeling lightheaded and he passed out. He felt better quickly after resting. No further clinical information was available for medical review. Inappropriate schedule of vaccine administration was also noted, primary vaccination series was administered in a 38-day interval. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2023-713956 (Patient Link).