Received Apr 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | 1 | Y011819 | OT / LA |
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | — | OT / RA |
syncope; dizziness; feeling abnormal; blood glucose normal; nausea; skin warm; This spontaneous report was received from a Regulatory Authority and refers to a 50-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions included diabetic. Concomitant therapies were not reported. On 17-Nov-2024, the patient started therapy with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), Injection (lot #Y011819, expiration date: 01-Oct-2025), dose number 1, administered by Intramuscular route in Left Arm. On an unknown date, the patient started therapy with . On 17-Nov-2024, the patient started therapy with ADACEL administered by Intramuscular route (indication, expiration date, and lot # were not reported). The patient started therapy with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), for the treatment of prophylaxis. On 17-Nov-2024, the patient experienced dizziness. On 17-Nov-2024, the patient experienced feeling abnormal. On 17-Nov-2024, the patient experienced blood glucose normal. On 17-Nov-2024, the patient experienced nausea. On 17-Nov-2024, the patient experienced skin warm. On 17-Nov-2024, the patient experienced syncope. On an unknown date, Investigation showed Blood sugar (??-???-0000): 111 (unit not provided). The patient recovered/resolved from the event of dizziness on an unspecified date. The patient recovered/resolved from the event of feeling abnormal on an unspecified date. The patient recovered/resolved from the event of blood glucose normal on an unspecified date. The patient recovered/resolved from the event of nausea on an unspecified date. The patient recovered/resolved from the event of skin warm on an unspecified date. The patient recovered/resolved from the event of syncope on an unspecified date. The action taken with Pneumococcal 21-valent Conjugate Vaccine was reported as not applicable. The action taken with Pneumococcal 21-valent Conjugate Vaccine Solution for injection was reported as not applicable. The causal relationship between the event of dizziness and Pneumococcal 21-valent Conjugate Vaccine was unknown/not reported/not provided. The causal relationship between the event of feeling abnormal and Pneumococcal 21-valent Conjugate Vaccine was unknown/not reported/not provided. The causal relationship between the event of blood glucose normal and Pneumococcal 21-valent Conjugate Vaccine was unknown/not reported/not provided. The causal relationship between the event of nausea and Pneumococcal 21-valent Conjugate Vaccine was unknown/not reported/not provided. The causal relationship between the event of skin warm and Pneumococcal 21-valent Conjugate Vaccine was unknown/not reported/not provided. The causal relationship between the event of syncope and Pneumococcal 21-valent Conjugate Vaccine was unknown/not reported/not provided. The reporter considered the event(s) of syncope to be medically significant. This is an amended report. The patient's age was updated from 6 months to 50 years.
Diabetes
Test Name: Investigation; Result Unstructured Data: Blood sugar (??-???-0000): 111 (unit not provided)