Received Feb 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | LJ5284 | LA |
redness over 13cm in diameters; cellulitis; infection; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 41-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 12Feb2025 as dose number unknown, single (Lot number: LJ5284, Expiration Date: 30Jun2025) at the age of 41 years, in left arm for immunisation; influenza vaccine (INFLUENZA VACCINE), from 12Feb2025) to 12Feb2025 at single (dose number unknown, single) for immunisation. The patient's relevant medical history included: "Ankylosing spondylitis" (ongoing), notes: Ankylosing spondylitis is a autoimmune. Concomitant medication(s) included: SIMPONI taken for ankylosing spondylitis; LEVOTHYROXINE taken for thyroid disorder; KEFLEX [CEFALEXIN]. The following information was reported: ERYTHEMA (non-serious), outcome "unknown", described as "redness over 13cm in diameters"; CELLULITIS (non-serious), outcome "unknown"; INFECTION (non-serious), outcome "unknown". Therapeutic measures were taken as a result of erythema, cellulitis, infection. Additional Information: Caller, a 41-year-old patient, was injected with pneumococcal vaccine. When asked for the name of the vaccine, caller stated that it's from REDACTED. She received the vaccine and it cost her to have an infection, redness over 13cm in diameters. According to the doctors it was cellulitis and they are not taking responsibility. Consumer was unaware of the dose of vaccination. Consumer stated, Yes, she had taken Simponi (50 mg), and she had taken it for Ankylosing spondylitis and that is why she went her physician and that is why they gave her the vaccine. Other concomitant medication was taken consumer stated, Levothyroxine, 100 mg for thyroid. Vaccine administered on same date with the Pfizer vaccine was yes it was another vaccine in the off the arms and that the flu vaccine.
Ankylosing spondylitis (Ankylosing spondylitis is a autoimmune)
SIMPONI; LEVOTHYROXINE; KEFLEX [CEFALEXIN]