Received Mar 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 2 | 3043836 | IM / RA |
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | 1 | Y011819 | IM / LA |
Distal patch with excoriation started day after receiving vaccine; Warmth to site; Chills; Fever; Erythematic patches on left arm; Left arm pain; This spontaneous case was reported by an other health care professional and describes the occurrence of SKIN ABRASION (Distal patch with excoriation started day after receiving vaccine), VACCINATION SITE WARMTH (Warmth to site), CHILLS (Chills), PYREXIA (Fever) and ERYTHEMA (Erythematic patches on left arm) in a 51-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043836) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Pneumococcal vaccine conj 21v (CRM197) (Capvaxive) for an unknown indication. The patient's past medical history included Palpitations, Pain in hip (Bilateral chronic hip pain), Hiatal hernia and Esophageal spasm (Esophageal spasms). Previously administered products included for Drug use for unknown indication: Celebrex. Past adverse reactions to the above products included Allergy with Celebrex. Concurrent medical conditions included Schizoaffective disorder, Obesity, Tobacco user, Insomnia, GERD, Adrenal adenoma, Dyslipidemia and Allergy to NSAIDs (Celebrex allergy). Concomitant products included Bupropion hydrochloride (Wellbutrin), Hydroxyzine hydrochloride (Atarax), Omeprazole (Prilosec), Ziprasidone hydrochloride (Geodon) and Hyoscyamine sulfate (Anaspaz) for an unknown indication. On 19-Dec-2024, the patient received second dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and first dose of Pneumococcal vaccine conj 21v (CRM197) (Capvaxive) (Intramuscular use) 1 dosage form. On 20-Dec-2024, the patient experienced SKIN ABRASION (Distal patch with excoriation started day after receiving vaccine), VACCINATION SITE WARMTH (Warmth to site), CHILLS (Chills), PYREXIA (Fever), ERYTHEMA (Erythematic patches on left arm) and PAIN IN EXTREMITY (Left arm pain). At the time of the report, SKIN ABRASION (Distal patch with excoriation started day after receiving vaccine), VACCINATION SITE WARMTH (Warmth to site), CHILLS (Chills), PYREXIA (Fever), ERYTHEMA (Erythematic patches on left arm) and PAIN IN EXTREMITY (Left arm pain) had not resolved. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. It was reported that after the day of vaccination, patient experienced reported events. Lad data was reported as vital signs were recorded. Current illness was reported as unknown. Patient was started on antibiotics on day 4 post vaccination after patient went to clinic again.
Adrenal adenoma; Allergy to NSAIDs (Celebrex allergy); Dyslipidemia; GERD; Insomnia; Obesity; Schizoaffective disorder; Tobacco user
Medical History/Concurrent Conditions: Esophageal spasm (Esophageal spasms); Hiatal hernia; Pain in hip (Bilateral chronic hip pain); Palpitations
Wellbutrin; Atarax; Prilosec; Geodon; Anaspaz