Received Apr 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | Not Reported | — |
HCP diagnosed as cellulitis; Patient came back to clinic 03/18/2025 with complaint of injection site pain, fever, redness that increased around injection site as well as swelling and induration. Redness continued to expand to 14 by 11 centimeters, area is tender to touch.; Patient came back to clinic 03/18/2025 with complaint of injection site pain, fever, redness that increased around injection site as well as swelling and induration. Redness continued to expand to 14 by 11 centimeters, area is tender to touch.; Patient came back to clinic 03/18/2025 with complaint of injection site pain, fever, redness that increased around injection site as well as swelling and induration. Redness continued to expand to 14 by 11 centimeters, area is tender to touch.; Patient came back to clinic 03/18/2025 with complaint of injection site pain, fever, redness that increased around injection site as well as swelling and induration. Redness continued to expand to 14 by 11 centimeters, area is tender to touch.; This spontaneous report was received from a Nurse and refers to a(n) 49-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 12-Mar-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), formulation: injection (lot #, expiration date, exact dose, route of administration, anatomical location and indication were not provided). On an unknown exact date in March 2025, the patient experienced cellulitis, vaccination site erythema, vaccination site induration, vaccination site pain, vaccination site swelling. Patient came back to clinic 10-Mar-2025 with complaint of injection site pain, fever, redness that increased around injection site as well as swelling and induration. Redness continued to expand to 14 by 11 centimeters, area is tender to touch. Patient was prescribed Benadryl and topical cortisone cream for symptoms as well as CEPHALEXIN. HCP diagnosed as cellulitis. On the same date, body temperature was 97.8 F, oxygen saturation was 99 %, heart rate showed 71 (units not provided), blood pressure showed 126/75 (units not provided). At the reporting time, the outcome of the events was unknown. The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was unknown/not reported/not provided.
Test Date: 20250318; Test Name: HR; Result Unstructured Data: 71 (units not provided); Test Date: 20250318; Test Name: Temp.; Result Unstructured Data: 97.8 [degF]; Test Date: 20250318; Test Name: O2; Test Result: 99 %; Test Date: 20250318; Test Name: BP.; Result Unstructured Data: 126/75 (units not provided)