Received May 11, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 1 | — | RA |
Peripheral neuropathy; Erythromelalgia; hives around the injection site in the right arm; This literature-non-study case was reported in a literature article and describes the occurrence of NEUROPATHY PERIPHERAL (Peripheral neuropathy) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. LITERATURE REFERENCE: The patient's past medical history included Tobacco user. Concurrent medical conditions included Depression. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced NEUROPATHY PERIPHERAL (Peripheral neuropathy) (seriousness criterion medically significant), ERYTHROMELALGIA (Erythromelalgia) and VACCINATION SITE URTICARIA (hives around the injection site in the right arm). At the time of the report, NEUROPATHY PERIPHERAL (Peripheral neuropathy), ERYTHROMELALGIA (Erythromelalgia) and VACCINATION SITE URTICARIA (hives around the injection site in the right arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Physical examination: Rash on presentation at the right arm injection site, foot, and hands. Redness and swelling below the injection site, along with a pruritic papular rash on the palms and soles and the dorsal surfaces of the feet. In June 2021, Histamine level (180-1800 nmol/L): 1813 nmol/L slightly elevated. In June 2021, Tryptase (Unknown-11.5 ng/mL): 4.6 ng/mL Reference provided. On an unknown date, Biopsy: of the thumb was unremarkable. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case refers to Patient 16 from Table 1 who received Moderna COVID-19 vaccine. Concomitant medications were not reported. The patient had no history of COVID-19. Eight days later, the patient developed hives around the injection site in the right arm. The following day, patient presented to physician's office with redness and swelling below the injection site, along with a pruritic papular rash on the palms and soles and the dorsal surfaces of the feet. Patient had no facial swelling, fever, or respiratory symptoms. The patient experienced burning, throbbing pain that felt like the sting of a billion mosquitoes. The patient presented to the emergency room (ER) on 17-Apr-2021 for persistent hives. The patient was administered methylprednisolone 125 mg intramuscularly and sent home with hydroxyzine, famotidine, and a rapid prednisone taper starting at 40 mg. Hives of the hands and feet returned after completion of the steroid taper. The hands continued to be very painful with worsening redness, for which she was prescribed triamcinolone cream on 17-May-2021. The symptoms rebounded once off the topical steroids. The patient was unable to work due to pain. On 03-Jun-2021, an allergy consultation suggested mast cell activation syndrome or histamine intolerance. Over the ensuing months, patient tried various other medications for hand pain and redness, including ketorolac, cetirizine, gabapentin, and montelukast, without any significant benefit. The patient was diagnosed with erythromelalgia at an outside institution in November 2021. The pruritus had resolved by this point. As of July 2023, patient continued to suffer the consequences of adverse event following immunization (AEFI). The patient continued to have dysesthesia of the distal extremities. The patient remained on pregabalin, aspirin, and venlafaxine. The application of compounded amitriptyline 2% and ketamine 0.5% cream had alleviated some of the pain. Approximate date of symptom onset in relation to vaccination was reported as 9 days. This was a descriptive case series prospectively identified and collected by the authors during formal or informal consultation from January to December 2021. The aims of this descriptive case series were twofold. First, to present detailed clinical case presentations of serious adverse events following immunization (AEFI)I with COVID-19 vaccines seen at one rural healthcare system during the first year after the introduction of COVID-19 vaccines. Second, to review the medical literature regarding similarly reported cases. Author concluded that they encountered a variety of AEFI with COVID-19 vaccines, including myocarditis, demyelinating disease, encephalitis, Bell's palsy, burning mouth syndrome, MIS, ITP, pneumonitis, colitis, staphylococcal infection, and erythromelalgia. This detailed case series were presented to help clinicians consider a diagnosis of AEFI when no other explanation had been found after a thorough diagnostic evaluation. These described adverse events following COVID-19 vaccination do not imply causality. They hope this descriptive case series leads to further case-control studies from healthcare organizations to explore the possible risks, incidence, and causal relationships of such adverse events following COVID-19 vaccination. This case was linked to US-MODERNATX, INC.-MOD-2026-795547 (E2B Linked Report).; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2026-795547:Patient Case Number 1 (22-year old male)
Depression
Medical History/Concurrent Conditions: Tobacco user
Test Name: Biopsy of the thumb; Result Unstructured Data: of the thumb was unremarkable; Test Date: 202106; Test Name: histamine; Result Unstructured Data: Test Result:1813 nmol/L;slightly elevated; Test Date: 202104; Test Name: Physical examination; Result Unstructured Data: Rash on presentation at the right arm injection site, foot, and hands. Redness and swelling below the injection site, along with a pruritic papular rash on the palms and soles and the dorsal surfaces of the feet; Test Date: 202106; Test Name: Tryptase; Result Unstructured Data: Test Result:4.6 ng/mL;Reference provided