Received Nov 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | 2 | 8058581 | OT / LA |
Lymphedema; limited range of motion; COVID arm symptoms; small patch of rash [on the arm]; COVID arm symptoms; pain [on the arm]; Nerve pain; Heaviness in whole arm; COVID arm symptoms; burning, warmth on the arm; This non-serious, initial spontaneous safety report was received by Novavax on 20-DEC-2023 from a consumer via the web portal. A 41-year-old female of an unspecified race was vaccinated with intramuscular Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (batch number 8058581) 0.5 milliliter suspect COVID-19 vaccine dose 2 (dose 4 of COVID-19 vaccine) in the left arm on 16-DEC-2023 at a pharmacy. Medical history included Endometriosis, Hyperthyroidism (in remission), and SARS-CoV-2 test positive on 25-OCT-2022. Allergies included Food allergy (legumes), Dermatitis contact (surgical tape and glue), and Allergy to vaccine (unspecified influenza and mRNA vaccines). The individual experienced Neuralgia, Limb discomfort, Rash, Pain in extremity, and Skin warm after prior vaccination with Pfizer BioNTech COVID-19 vaccine (tozinameran) dose 1 on 07-JUL-2021 and dose 2 on 27-JUL-2021, and Novavax COVID-19 Vaccine, Adjuvanted (original formula) dose 1 (dose 3 of COVID-19 vaccine) on 23-FEB-2022. The individual was not taking any concomitant medications. On unspecified dates, after vaccination, the individual experienced nerve pain (PT: Neuralgia) and heaviness in her whole arm (PT: Limb discomfort). She also experienced COVID arm symptoms, including a small patch of rash (PT: Rash), pain (PT: Pain in extremity), and warmth on the arm (PT: Skin warm). It was reported the individual developed these symptoms after every vaccine. She received no treatment for the adverse events. At the time of reporting, the event outcome of Neuralgia, Limb Discomfort, Rash, Pain in extremity, and Skin warm were recovering/resolving. On 24-Jun-2024, additional information was received from a consumer via a query response: Updated the onset date of the following events Nerve pain, Heaviness in whole arm, COVID arm symptoms; small patch of rash (on the arm), COVID arm symptoms; pain (on the arm), COVID arm symptoms; warmth on the arm to 17-Dec-2023. Updated treatment performed to Yes with Treatment description physical therapy for COVID arm symptoms; pain (on the arm), COVID arm symptoms; warmth on the arm. Updated the outcome of the events nerve pain, heaviness in whole arm, pain on the arm, and warmth on the arm to Not Recovered/Not Resolved. Updated the outcome of the event COVID arm symptoms; small patch of rash (on the arm) to Recovered/Resolved with cessation date of 15-Jan-2024. New events were added to the case: Lymphedema and limited range of motion with unknown onset date and outcome of Not Recovered/Not Resolved/Ongoing. Treatment included physical therapy. A discrepancy was noted on the source document. The event cessation date was documented as 15-Jan-2023 which was before the event onset date. On 11-Sep-2024, additional information was received from a consumer via a query response: Updated disease type of Allergy to Legumes and added Seasonal Allergies under Medical History. Updated patient's past therapy with removed adverse reactions to previous vaccination. Updated COVID-19 mRNA Vaccine and Flu Vaccine Start Date under Patient Past Therapy. Updated therapy dosage text. Updated Lymphedema outcome to "Recovered/Resolved" and added cessation date of Jul-2024 Added an additional event reported term of burning for PT: Skin Warm Added COVID-19 Molecular Test Positive Lab Data Sender's Comments: This 41 year-old Female experienced Lymphoedema, Joint range of motion decreased, Neuralgia, Limb discomfort, Rash, Pain in extremity and Skin warm after vaccination with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula). The events Lymphoedema, Joint range of motion decreased, Neuralgia, Limb discomfort, Rash, Pain in extremity and Skin warm were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) and the reported events is considered Possible. Additional information was received on 11-Nov-2025 from consumer/ non-healthcare professional: Batch number added, Causality and listedness updated as not added in the previous version, narrative amended accordingly.; Sender's Comments: US-Novavax, Inc-2023NVX-US-000001973:
Adhesive tape allergy; Allergy to legumes; Asthma; Drug allergy; Endometriosis; Hyperthyroidism (In remission); Penicillin allergy; Seasonal allergy
Medical History/Concurrent Conditions: COVID-19 PCR test positive
Test Date: 20221023; Test Name: COVID-19 MOLECULAR TEST POSITIVE; Test Result: Positive