Received May 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | — | OT |
I didn't really get much of a type 2 reaction, you know the big bump on your arm; I didn't really get much of a type 2 reaction, you know the big bump on your arm; This serious initial spontaneous safety report was received by Novavax on 29-Apr-2025 from an Other health professional via contact center (MI No. NOV25-00250). A 42-year-old female was vaccinated with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (Intramuscular) (Lot number was not provided in the report) on Nov-2023. The following medical history was reported: HYPOGAMMAGLOBULINEMIA, AUTO-INFLAMMATORY CONDITION, YAO SYNDROME, LONG COVID, 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, BEE ALLERGY, BEE'S WAX AND HONEY ALLERGY, METRONIDAZOLE ALLERGY, IODINE CONTRAST ALLERGY and IMMUNOCOMPROMISED. The following concomitant medications were reported: MITOCHONDRIAL NRG(d-ribose), GAMMAGARD(immunoglobulin human normal), SULFADIAZINE(sulfadiazine), METFORMIN(metformin), MESTINON(pyridostigmine bromide), FAMOTIDINE(famotidine), LORATADINE(loratadine), ACETYSALICYLIC ACID(acetylsalicylic acid), CROMOLYN [CROMOGLICIC ACID](cromoglicic acid), DIGESTIVE ENZYMES [BETAINE HYDROCHLORIDE;BROMELAINS;CELLULASE;PANCREATIN;PAPAIN](betaine hydrochloride), MAGNESIUM(magnesium), NIACIN(nicotinic acid), MIRTAZAPINE(mirtazapine), NALTREXONE(naltrexone), SYMBICORT(formoterol fumarate), ALBUTEROL [SALBUTAMOL SULFATE](salbutamol sulfate), ATROVENT(ipratropium bromide), FLONASE [MOMETASONE FUROATE](mometasone furoate), BENADRYL [ACRIVASTINE](acrivastine), VYVANSE(lisdexamfetamine mesilate), METOPROLOL(metoprolol), CORLANOR(ivabradine hydrochloride), NATAZIA(estradiol valerate), SLYND(drospirenone) and ZYRTEC [LEVOCABASTINE HYDROCHLORIDE](levocabastine hydrochloride). On unspecified dates after vaccination the patient experienced "I didn't really get much of a type 2 reaction, you know the big bump on your arm (Type II hypersensitivity) (Serious: Other Medically Important Condition)" and "I didn't really get much of a type 2 reaction, you know the big bump on your arm" (Injection site mass). At the time of reporting, the outcomes of events Type II hypersensitivity and Injection site mass were Unknown. Additional case number for this patient included: 2025-NVX-US-00307.; Sender's Comments: This 42-year-old female experienced Type II hypersensitivity and Injection site mass after vaccination with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula). The event Type II hypersensitivity was reported as serious. The event Injection site mass was reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) and Type II hypersensitivity and Injection site mass is considered Possible.
Allergy to intravenous contrast media; Bee sting hypersensitivity; Drug allergy; Honey allergy; Immunocompromised; 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
Mitochondrial supplements; Gammagard; Sulfadiazene; Metformin; Mestinon; Famotidine; Loratadine; Aspirin; Cromolyn; Digestive enzymes; Magnesium; Niacin; Mirtazapine; Naltrexone; Symbicort; Albuterol; Atrovent; Flonase; Benadryl; Vyvanse; M