Received Mar 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | Y013009 | IM / RA |
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | Y013009 | RA |
localize reaction where the CAPVAXIVE was administered on the upper right arm/the patient reported burining and itching over and around the affected injection site area; localize reaction where the CAPVAXIVE was administered on the upper right arm/the patient reported burining and itching over and around the affected injection site area; the skin looked like "it may break and begin weaping" in the affected area with "fissure cracks"; localize reaction where the CAPVAXIVE was administered on the upper right arm/reddened, and warm to the touch; Localize reaction where the CAPVAXIVE was administered on the upper right arm/reddened, and warm to the touch/the patient reported burning over and aro8und the affected injection site area; localize reaction where the CAPVAXIVE was administered /almost as big as a grapefruit/the reaction was bigger/ and had spread to approximately 1-2cm beyond the circled border near the bottom "where gravity would pull it down"; Low grade temperature; Significant discomfort; Body/bone aches; Body/bone aches; This spontaneous report was received from a nurse practitioner and regarding to a 56-year-old female patient. The patient's medical history included hypertension and history of respiratory infection, actinic keratosis, basal cell carcinoma upper extremity and eyelid, fair skin and blond hair. Concomitant medications included Bupropion hydrochloride (WELLBUTRIN XL), Estradiol benzoate (ESTRADIOL PATCH), lisinopril hydrochlorothiazide (hctz), naltrexone, progesterone and tirzepatide. On 11-MAR-2025, the patient started therapy with pneumococcal 21-valent conjugate vaccine (CAPVAXIVE) INJ 168 mcg/ml, 0.5 mL, once, via injection intramuscular (IM) on the upper right arm, lot number Y013009 (lot number Y013009 had been verified to be valid lot number for, expiration date was reported as 17-DEC-2025, but upon an internal validation, established as 17-NOV-2025), as 56 range vaccination (prophylaxis). The reporter stated the patient began having a low grade temperature, significant discomfort and body/bone aches on 11-MAR-2025 and next day 12-MAR-2025, after the injection which resolved by the next morning 13-MAR-2025 (recovered), but then the patient reported a localize reaction where the pneumococcal 21-valent conjugate vaccine (CAPVAXIVE) was administered on the upper right arm in which the patient sought medical attention from the health care professional (HCP). The HCP described the reaction on 13-MAR-2025, as being "significant" and almost as big as a grapefruit, reddened, and warm to the touch, so the HCP circled the borders of the reaction site and prescribed sulfamethoxazole;trimethoprim (BACTRIM) because she was concerned about cellulitis, and told the patient to return if the reaction became larger than the circled ring. The patient returned to the HCP on 14-MAR-2025, because the reaction was bigger and had spread to approximately 1-2cm beyond the circled border near the bottom "where gravity would pull it down" and approximately 1cm beyond the circled border near the top shoulder and posterior part of the arm, additionally, the HCP stated the skin looked like "it may break and begin weaping" in the affected area with "fissure cracks" and the patient reported burning and itching over and around the affected injection site area. The HCP stated she prescribed triamcinolone steroid cream, mupirocin antibiotic cream, and ice packs for 15 minutes to the affected site every four hours. The HCP stated although the patient had been in significant discomfort, she did feel the patient was improving and "on the other side". The HCP offered to send pictures of the reaction. The HCP stated she was considering getting pneumococcal 21-valent conjugate vaccine (CAPVAXIVE) herself, but after her patient's reaction to the vaccine she was thinking twice about it. No additional adverse event (AE). No product quality complaint (PQC). At the reporting time, the patient was recovering from vaccination site pruritus, vaccination site erythema, vaccination site warmth, vaccination site inflammation, vaccination site burning and vaccination site desquamation. The causal relationship between the events and pneumococcal 21-valent conjugate vaccine (CAPVAXIVE) were not provided.
Medical History/Concurrent Conditions: Actinic keratosis; Basal cell carcinoma; Hypertension; Respiratory infection
Wellbutrin XL; Estradiol patch; lisinopril HCTZ combo drug; Naltrexone; progesterone; tirzepatide