Received Jun 8, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | 1 | Z013321 | IM / RA |
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | Z013321 | OT / RA |
high blood sugars; swelling and redness at injection site; body aches; Headache; swelling and redness at injection site; fever; Information has been received from Food and Drug Administration (FDA) (2888816-1). This spontaneous report refers to a 54-years-old male patient. The patient's concurrent conditions included Hypertension, DM type 2, Hyperlipidemia, obesity, and allergy to niacin. The patient's past medications and concomitant medications were not reported. On 09-Mar-2026, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine Solution for injection (CAPEXIVE) 1 dosage form, lot Number: Z013321 with no expiration date that has been verified to be valid with expiration date established as: 02-Jun-2027, administered via Intramuscular on right arm. On 10-Mar-2026, the patient experienced swelling and redness at injection site (Injection site swelling and Injection site erythema), body aches (Pain), high blood sugars (Blood glucose increased), headache (Headache) and with fever (Pyrexia). The outcome of the events were not provided. The causal relation between the events and suspect vaccine were not provided.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : [email protected] , Index date : 2026-05-27 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2888816 , Central date : 2026-05-26 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Drug allergy; Hyperlipidemia; Hypertension; Obesity; Type 2 diabetes mellitus