Received Apr 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | 1 | — | — |
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | 2 | Y019158 | — |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
Patient reported that she does not feel good, and pharmacist stated he thinks patient is experiencing general malaise.; Patient reported that she does not feel good, and pharmacist stated he thinks patient is experiencing general malaise.; Pharmacist reported patient received a second dose of CAPVAXIVE on Apr 15, 2025. Pharmacist explained that patient received first dose of CAPVAXIVE in Colorado, so his electronic medical system did not notify him because it only picks up medications; Information has been received from Business Partner/CRO on 16-Apr-2025. This spontaneous report was received from an Consumer or other non health professional and refers to a female patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 15-Apr-2025, the patient started therapy with Pneumococcal 21-valent Conjugate Vaccine (lot #Y019158, expiration date: 20-May-2026), dose number 2,. On Feb-2025, the patient started therapy with Pneumococcal 21-valent Conjugate Vaccine, dose number 1, (lot # and expiration date were not reported). On 15-Apr-2025, the patient was vaccinated with two doses of non-product or non-Merck product (indication, expiration date, and lot # were not reported) (Extra dose administered). On unknown date, the patient reported that she does not feel good, and pharmacist stated he thinks patient is experiencing general malaise. At the reporting time, the outcome of all of the events was unknown. The action taken with all of the vaccines was reported as not applicable. The causal relationship between all of the events and Pneumococcal 21-valent Conjugate Vaccine was unknown/not reported/not provided. The causal relationship between all of the events and non-product or non-Merck product was unknown/not reported/not provided.