Received May 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | 1 | ZOo4301 | LA |
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | — | OT |
rash on her arm where she got the injection and it also started on her legs; her arm was swollen at the injection site; headache; indication: Pneumococcal; Information has been received from a 71 years old female patient and referred to herself. The patient had no medical history. The patient's concurrent conditions included allergic to aspirin, penicillin, levothyroxine, and sulfamethoxazole (+) trimethoprim (BACTRIM). Concomitant therapy included "METHROTREC" 10mg once weekly, the patient was advised to stop the medication during the week she got the vaccine. On 20-MAY-2025, the patient vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) Injection (strength, dose, frequency, route, lot # and expiration date were not reported) for Pneumococcal (Product use in unapproved indication). She thought she was receiving the Pneumococcal vaccine conj 20v (CRM197)(PREVNAR 20), however she was administered Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE). On 21-MAY-2025 (the second day after she received the vaccine), the patient's arm was swollen at the injection site (Vaccination site swelling) and she had a headache. On 25-MAY-2025 (the day five), she started getting a rash on her arm where she got the injection, and it also started on her legs and the rash lessens when she wears loose clothes (Rash). The reporter said the rash was better but has not gone away, the outcome of the event rash was considered as recovering. The outcome of other events of Vaccination site swelling and headache was reported as not recovered. The causal relationship between the events of Vaccination site swelling, Headache, Rash and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported. Lot# is being requested and will be submitted if received.
Drug allergy