Received Feb 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19-2 | COVID19 (COVID19 (MODERNA BIVALENT)) | MODERNA | UNK | 013H22A | IM |
left facial nerve palsy; small fiber peripheral neuropathy; This spontaneous case was reported by a patient and describes the occurrence of FACIAL PARALYSIS (left facial nerve palsy) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Unspecified hypothyroidism, Hyperlipidemia, Constipation chronic and Cancer (cancer survivor (2001)) since 2021. On 27-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) 1 dosage form. In November 2022, the patient experienced SMALL FIBRE NEUROPATHY (small fiber peripheral neuropathy). In 2023, the patient experienced FACIAL PARALYSIS (left facial nerve palsy) (seriousness criterion medically significant). The patient was treated with Pregabalin at an unspecified dose and frequency. At the time of the report, FACIAL PARALYSIS (left facial nerve palsy) and SMALL FIBRE NEUROPATHY (small fiber peripheral neuropathy) had not resolved. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Suspect vaccine dosage text was reported as booster. She received the Moderna booster on 27-Oct-2022 and two weeks later between November 15th-20th she developed numbness of the right fifth toe and foot outer border, discomfort of the right lower back area (butt), sciatica like symptoms which kept progressing. It progressed and then developed like burning, numbness, tingling, pain of hands, feet, facial (around the lips/mouth) and all extremities and face. In 2023 reporter was then diagnosed with small fiber peripheral neuropathy. On Mar-2023, neurologist placed reporter on steroids, responded very well to the steroids, got better but after the steroids wore off, it all came back. Now has developed left facial nerve palsy and taking pregabalin (start date Jun or July 2023), did not control symptoms very well, could not tolerate high doses and still symptomatic. Reporter causality was not reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Cancer (cancer survivor (2001)); Constipation chronic; Hyperlipidemia; Unspecified hypothyroidism