Received Sep 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | N/A | Y019158 | IM / RA |
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | 1 | Y019158 | OT / RA |
CELLULITIS; IMMUNISATION REACTION; Information has been received from Food and Drug Administration Agency (FDA) via Vaccine Adverse Events Reporting System (VAERS) (agency #2845108-1) on 20-Aug-2025. This spontaneous report refers to a 58-year-old female patient. The patient's medical history was not reported. As concurrent conditions were reported prediabetes, Hypothyroidism, Chronic low back pain, Hypercholesterolemia, allergy to adhesive, allergy to latex, allergy to Penicillin and allergy to Codeine (it was reported that the allergies to penicillin and sulfa, cause nausea and vomiting). It was confirmed that she has a history of vaccine administration without prior adverse reactions. Concomitant medications included Tirzepatide(ZEPBOUND), Levothyroxine sodium(SYNTHROID), Cefalexin(KEFLEX) and Methocarbamol(ROBAXIN) . On 05-Jun-2025, the was vaccinated with a dose of Pneumococcal 21-valent Conjugate Vaccine(CAPVAXIVE)) (lot #Y019158, expiration date: 20-May-2026), dose number 1, administered by Intramuscular route in Right Arm as prophylaxis. On 06-Jun-2025, the patient experienced cellulitis of right upper extremity. The patient reported that the injection site had become red, warm to the touch, and had been progressively worsening since the day after the shot. The redness intensifies throughout the day and was accompanied by burning and itching. She denies fevers, chills, dysphagia or swelling and stated that the typical post-vaccine arm soreness had resolved, leaving only the redness and warmth. The patient expressed concern about taking antihistamines due to her eye condition, as she was being monitored for glaucoma (not reported as concurrent condition). As they suspect of a possible bacterial infection. She was prescribed with cefalexin(KEFLEX) (also reported as concomitant medication) 500mg four times a day for seven days, noting the potential for cross-reactivity but deeming it appropriate based on the nature of penicillin allergy. She was advised to monitor for spreading redness, fevers, or chills over the next two days and to report any worsening symptoms and was recommended to use over-the-counter anti-itch cream or hydrocortisone to help with the itching. Additional, was discussed the possibility of soft tissue infection or a vaccine reaction causing an infection between the skin layers. On 16-Jun-2025, during a follow up, the patient stated that she sees "definite improvement" (discrepant information as the outcome was reported as "not recovered"). She stated that the site "remains a little bit sore, but the redness and swelling have gone down, not totally resolved but has improved". Patient denied any issues with the antibiotic and was due to complete the antibiotic course on 19-Jun-2025. She stated she had skipped one dose 14-Jun-2025 and noticed that her arm was burning a bit more. She stated she took her dose as soon as she could and was back on schedule. The causal relationship between the event of immunisation reaction and cellulitis and Pneumococcal 21-valent Conjugate Vaccine(CAPVAXIVE) was reported to be related.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-08-20 , number : , number : , number : , number : , Central date : 2025-08-20 , Classification : , Attachment description : Post Marketing Basic , Safety case number :
Allergy; Drug allergy; Hypercholesterolemia; Hypothyroidism; Latex allergy; Low back pain; Penicillin allergy; Prediabetes
Zepbound; Synthroid; Keflex; Robaxin