Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | — | IM / LA |
Blister at the Bottom of the Ear Lobe; A Red Spot, Spread Down the Neck to the Clavicle, It's a Red Rash; Initial report received on 17-Mar-2025. A consumer reported that she, a 57-year-old female, received non-branded hepatitis B vaccine for hepatitis B immunization and developed a red spot (red rash) on the right side of her neck that spread down to the clavicle and a blister at the bottom of her ear lobe. No medical history or concomitant medications were reported. On 06-Mar-2025, the patient received dose 1 of a hepatitis B vaccine intramuscularly in the left arm. On an unknown date, after receiving hepatitis B vaccine, the patient reported a red spot on the right side of her neck that spread down to her clavicle. She reported this as a red rash. On 17-Mar-2025, 12 days after receiving HEPLISAV-B, the patient reported that she found a blister at the bottom of her ear lobe. The patient noted the other potential cause of the rash could be imitation large silver hoop earrings she wore on 09-Mar-2025. The patient's rash has improved and is noted to be resolving. No additional information was reported. Company Comment: ?The company assessed the events as non-serious.; Sender's Comments: ?The company assessed the events as non-serious.