Received Feb 27, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | — | — |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
| HPVX | HPV (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | — | — |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| HPVX | HPV (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| HPVX | HPV (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
PT has not a lot of fat, so that is a concern; PT was getting bad skin reaction/ PT states she broke out in hives, itchiness, swelling, after 2 weeks/ Infused in legs, hips.; HPV vaccine (product origin unknown); Information was received from a business partner on 19-Feb-2026. This spontaneous report was received from a patient referring herself as a currently 50-year-old female patient. Her medical history, concurrent conditions and concomitant therapies were not reported. On unreported date (s), the patient was vaccinated with an unspecified human papillomavirus (HPV) vaccine (exact dose, dosage regimen, batch/lot #, expiration date, anatomical location and route of administration were not reported) (product origin unknown) administered as prophylaxis; with an unspecified influenza vaccine (reported as "flu" vaccine) (exact dose, dosage regimen, batch/lot #, expiration date, anatomical location, route of administration and indication were not reported); and with an unspecified coronavirus disease (COVID) -19 vaccine (reported as "COVID" VACCINE); and started therapy with immunoglobulin human normal (HIZENTRA), strength and formulation reported as "4", infused in legs and hips (route of administration reported as "unknown"; dose, frequency, batch/lot #, expiration date, and indication were not reported.) On an unknown date (reported as "after 2 weeks"), the patient experienced bad skin reaction; she stated she broke out in hives, itchiness and swelling (urticaria). She stated this happened after flu, COVID, and HPV vaccine. In addition, since an unknown date, the patient did not have a lot of fat, so that was a concern (body fat disorder.) At the reporting time, the outcome of the events was unknown. The causal relationship between urticaria, body fat disorder and the suspect products was not reported. However, patient stated her symptoms were triggered by a live vaccine. Information was initially received by business partner on 20-Jan-2026 and captured on case AU-009507513-2373667. The case safety report UID number AU-009507513-2373667 is being deleted from our files and information was copied into case safety report UID number US-009507513-2384959 due to incorrect UID number as country of the reporter was corrected.
Hizentra