Received Mar 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | 6024MF016A | IM / LA |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 388532 | IM / LA |
Burning sensation shoots from top of bicep of mid forearm and occasionally moves; Bruise that extended down his entire left bicep; Injection site pain; Injection had no issue once needle was swapped.; This spontaneous case, initially received on 26-Feb-2025, was reported by a non health professional and concerns an adult male patient. Past medical history included High blood pressure, Gout, High cholesterol, prediabetes. Concomitant medication: refer to appropriate report section. Administration of company suspect drug: On 29-Oct-2024, the patient received Flucelvax (TIV) for Drug use for unknown indication, Dose regimen: not reported, Route of administration: Intramuscular, Anatomical location: Left arm, Lot number: 388532. Non-company suspect drugs: On 29-Oct-2024, the patient received, Novavax COVID-19 Vaccine (COVID-19 vaccine prot. subunit (NVX CoV 2373)), Indication: COVID-19 immunization. Anatomical site: left arm, lot number: 6024MF016A Adverse reactions/events and outcomes: On 29-Oct-2024, the patient experienced Injection had no issue once needle was swapped. (outcome: Recovered / Resolved, stop date: 29-Oct-2024). On 02-Nov-2024, the patient experienced Burning sensation shoots from top of bicep of mid forearm and occasionally moves (outcome: Not recovered / Not resolved), Bruise that extended down his entire left bicep (outcome: Not recovered / Not resolved), Injection site pain (outcome: Not recovered / Not resolved). The Non health professional reported that patient received two vaccine in the left arm on 29-Oct-2024. When injecting the novavax vaccine it was discovered that the needle was faulty (needle would not allow injection to occur) and had to be switched out after initial poke to a new needle. Injection had no issue once needle was swapped. Patient stated that over the next few days a bruise developed that extended down his entire left bicep and he started to develop a burning sensation about 3 days after injection. The sensation shoots from top of bicep to mid forearm and occasionally moves down to fingertips and certain movements when patient moves from close to body to out of body can aggravate the sensation, lifting weights or letting arm hang do not aggravate. Patient presented to urgent care on 03-Nov-2024. They did an x ray and could not find anything wrong. Patient started OTC ibuprofen 400 mg every 8 hours as he was unsure that it was helping or if it was more of a placebo effect. Patient went to clinic for an annual check-up on 13-Dec-2024 and prescribed to start physical therapy which he will start on 06-Jan-2025. The physician hopes to do an MRI to get further imaging results after physical therapy was started and discrepancy was identified in the source document. Lab data details: X-ray: Did not have any findings of note Flucelvax (TIV) action taken: Not Applicable Treatment medication: Ibuprofen 400 mg Three times a day Reporter's assessment: The reporter consider event as non-serious and causality was not reported; Reporter's Comments: The causality of all events was assessed related to the administration of Flucelvax (TIV) except needle issue assessed as not related.
Medical History/Concurrent Conditions: Blood pressure high; Gout; High cholesterol; Prediabetes
Fish oil; Vit d; Pseudoephedrine; Align