Received Jan 26, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | — | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
Guillain-Barré Syndrome; This spontaneous report was received from a Physician and refers to a male patient of unknown age (age reported as 50+). The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (dose, route and site of administration, lot # and expiration date were not reported) administered into arm (unspecified) for prophylaxis. On the same day, but in the opposite arm, the patient was also vaccinated with varicella zoster vaccine rgE (SHINGRIX)) (dose, route and site of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, approximately 1 year ago, the patient experienced Guillain-Barré Syndrome after receiving the suspect vaccines. At the reporting time, the outcome of Guillain-Barré Syndrome was unknown. At the time of the report, the outcome of the event was not provided. The action taken with the suspect vaccines was not applicable. The causal relationship between the event of Guillain-Barré Syndrome the suspect vaccines was not provided. Upon internal review, the event of Guillain-Barré Syndrome was determined to be medically significant. Lot # is being requested and will be submitted if received.