Received May 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (NOVAVAX)) | NOVAVAX | UNK | 3024MF012 | OT |
Walking got worse; It was itchy, hard, type 2 reaction; It was itchy, hard, type 2 reaction; And this time I was so sore because she rubbed it; It was itchy, hard, type 2 reaction; It was itchy, hard, type 2 reaction; She had COVID again recently and it almost killed her; COVID; Vaccination failure; This serious initial spontaneous safety report was received by Novavax on 29-Apr-2025 from an other health professional via Novavax Medical Information (AE Number: NOV25-00250). A 43 year-old female was vaccinated with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula)(Intramuscular) (LOT: 3024MF012) on 04-Oct-2024. The following medical history was reported: LONG COVID, HYPOGAMMAGLOBULINEMIA, AUTO-INFLAMMATORY CONDITION, YAOS SYNDROME, MCAS, POTS, SMALL FIBER NEUROPATHY FROM LONG COVID, SEVERE ASTHMA, VOCAL CORD DYSFUNCTION, METABOLIC SYNDROME, AUTONOMIC DYSFUNCTION, SEVERE GASTROPARESIS, GI DYSMOTILITY, LATEX ALLERGY, PENICILLIN ALLERGY, BEES ALLERGY, BEES WAX AND HONEY ALLERGY, METRONIDAZOLE ALLERGY, IODINE CONTRAST ALLERGY and IMMUNOCOMPROMISED. The following concomitant medications were reported: GAMMAGARD(immunoglobulin human normal), SULFADIAZINE(sulfadiazine), METFORMIN(metformin), MESTINON(pyridostigmine bromide), FAMOTIDINE(famotidine), LORATADINE(loratadine), ASPIRIN [ACETYLSALICYLIC ACID](acetylsalicylic acid), CROMOLYN [CROMOGLICATE SODIUM](cromoglicate sodium), MAGNESIUM(magnesium), NIACIN(nicotinic acid), MIRTAZAPINE(mirtazapine), NALTREXONE(naltrexone), SYMBICORT(formoterol fumarate), ALBUTEROL [SALBUTAMOL](salbutamol), ATROVENT(ipratropium bromide), FLONASE [FLUTICASONE PROPIONATE](fluticasone propionate), BENADRYL [DIPHENHYDRAMINE](diphenhydramine), VYVANSE(lisdexamfetamine mesilate), METOPROLOL(metoprolol), CORLANOR(ivabradine hydrochloride), NATAZIA(estradiol valerate), SLYND(drospirenone), ZYRTEC [CETIRIZINE HYDROCHLORIDE](cetirizine hydrochloride), MITOCHONDRIAL NRG(creatine) and DIGESTIVE ENZYMES [BETAINE HYDROCHLORIDE;BROMELAINS;CELLULASE;PANCREATIN;PAPAIN](betaine hydrochloride). On an unspecified dates, after vaccination the patient experienced "It was itchy, hard, type 2 reaction" (Type II hypersensitivity) (Serious: Other Medically Important Condition), "Walking got worse" (Gait disturbance), "It was itchy, hard, type 2 reaction" (Injection site pruritus), "It was itchy, hard, type 2 reaction" (Injection site mass), and "And this time I was so sore because she rubbed it" (Pain). On 04-Oct-2024, day 1 after vaccination the patient experienced Vaccination failure (Vaccination failure) (Serious: Other Medically Important Condition). On 30-Dec-2024, 88 days after vaccination the patient experienced "She had COVID again recently and it almost killed her" (COVID-19) (Serious: Other Medically Important Condition). Relevant lab tests included: COVID-19 TEST(Result: Positive, Test Date: 30-Dec-2024). At the time of reporting, the event outcomes of Type II hypersensitivity, Gait disturbance, Injection site pruritus, Injection site mass, Pain, and COVID-19 were Unknown and Vaccination failure was Recovered/Resolved. Additional case number for this patient included: 2025-NVX-US-00312. A discrepancy was identified in the source document where the administration date of Novavax vaccine was reported as 01-Oct-2024 and 04-Oct-2024. 04-Oct-2024 was captured in the case.; Sender's Comments: This 43 year-old female experienced Type II hypersensitivity, Vaccination failure, Gait disturbance, Injection site pruritus, Injection site mass, Pain and COVID-19 after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The events Type II hypersensitivity, Vaccination failure and COVID-19 were reported as serious. The events Gait disturbance, Injection site pruritus, Injection site mass and Pain were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and COVID-19, Type II hypersensitivity, Gait disturbance, Injection site pruritus, Injection site mass and Pain is considered Possible, and between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Vaccination failure is considered Related.
Bee sting hypersensitivity; Drug allergy; Honey allergy; Immunocompromised; Iodine contrast media allergy; Latex allergy; Long COVID; Mast cell activation syndrome; Penicillin allergy; Small fiber neuropathy
Medical History/Concurrent Conditions: Asthma; Autoinflammatory disease; Autonomic dysfunction; Gastrointestinal motility disorder; Gastroparesis; Hypogammaglobulinemia; Metabolic syndrome; Postural orthostatic tachycardia syndrome; Vocal cord dysfunction; Yao syndrome
IV Gammagard; Sulfadiazene; Metformin; Mestinon; Famotidine; Loratadine; Aspirin; Cromolyn; Magnesium; Niacin; Mirtazapine; Naltrexone low dose; Symbicort; Albuterol; Atrovent; Flonase; Benadryl; Vyvanse; Metropolol; Corlanor; Natazia; Slyn
Test Date: 20241230; Test Name: COVID-19 TEST; Test Result: Positive