Age: 57.0
Sex: F
Vaccine: FLUX, UNK
Symptoms: Dizziness, Erythema, Headache, Nasopharyngitis, Peripheral swelling
Clinical narrative: Faint; Dizzy/ Lightheaded like a balloon/ / Feeling like she was going to fall over; headache; swelling on her arm; redness; itchiness; cold; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Faint) in a 57-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030535) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    No Medical History information was reported.   On 09-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 10-Oct-2023, the patient experienced SYNCOPE (Faint) (seriousness criterion medically significant) and DIZZINESS (Dizzy/ Lightheaded like a balloon/ / Feeling like she was going to fall over). In October 2023, the patient experienced PERIPHERAL SWELLING (swelling on her arm), ERYTHEMA (redness), PRURITUS (itchiness), NASOPHARYNGITIS (cold) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SYNCOPE (Faint), PERIPHERAL SWELLING (swelling on her arm), ERYTHEMA (redness), PRURITUS (itchiness), NASOPHARYNGITIS (cold), DIZZINESS (Dizzy/ Lightheaded like a balloon/ / Feeling like she was going to fall over) and HEADACHE (headache) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported.  Halfway through the night after receiving the most recent dose of the vaccine she felt dizzy, lightheaded like a balloon, and faint. She went to work, where she felt she got worse. Feeling like she was going to fall over, was dizzy, cold, and had a headache. She also had some swelling on her arm, itchiness, and redness. She called her doctor who recommended ice on her arm, Tylenol, rest, and drinking lots of fluids. She had attempted these treatments. Company comment: This spontaneous case concerns a 57-year-old female patient, with no medical history reported, who experienced the unexpected and serious (medically significant) event of SYNCOPE, halfway through the night after receiving an unspecified dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) vaccine, among other non-serious events. Vaccination with influenza vaccine on the same day remains as a confounder for the event. She took paracetamol, rest, and drank fluids as treatment. No further clinical information was available for medical review. She reported having received previous doses of the COVID-19 vaccines without any specifications. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-745400 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745400:Spikevax NOS case (Same patient)