Received Nov 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| VARZOS | ZOSTER LIVE (ZOSTAVAX) | MERCK & CO. INC. | 2 | — | — |
| VARZOS | ZOSTER LIVE (ZOSTAVAX) | MERCK & CO. INC. | 1 | — | — |
feeling tired; feverish; achy; weak; This spontaneous report was received from a Consumer or other non health professional (on behalf of his wife) and refers to a 71-year-old female patient. The patient's medical history included a surgery (not specified). The patient's concurrent conditions included pancreatic cancer. Concomitant medications included Gabapentin. On an unknown date (reported as "some time ago"), the patient started therapy with pembrolizumab (KEYTRUDA), Solution for infusion administered by Intravenous (not otherwise specified) route, every 6 weeks (exact dosage, lot # and expiration date were not reported) for pancreatic cancer. The wife began an "unknown" chemotherapy and pembrolizumab (KEYTRUDA), but finished the chemotherapy around July 2025 (reported as "approximately 12 weeks ago") and continued on pembrolizumab (KEYTRUDA) as a single agent. The consumer stated his wife has been doing well on pembrolizumab (KEYTRUDA) and had never experienced any adverse issues or side effects from the prior treatments in the past. On an unknown date (reported as "mid-August"), the patient was vaccinated with Zoster Vaccine Live (manufacturer unknown), Solution for injection, dose number 1, (route of administration, anatomical location, exact dosage, lot # and expiration date were not reported), which was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT), Solution for injection (1st dose), (route of administration, anatomical location, exact dosage, lot # and expiration date were not reported) as prophylaxis. In which she also did not experience any adverse issues or side effects. On Monday 06-OCT-2025, she received her last dose of pembrolizumab (KEYTRUDA). Then on Wednesday 08-Oct-2025, the patient was vaccinated with Zoster Vaccine Live (manufacturer unknown), Solution for injection, dose number 2, (route of administration, anatomical location, exact dosage, lot # and expiration date were not reported), which was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT), Solution for injection (2nd dose), (route of administration, anatomical location, exact dosage , lot # and expiration date were not reported) as prophylaxis. On the same day she also was vaccinated with Flu (Influenza vaccine) (route of administration, anatomical location, exact dosage, lot # and expiration date were not reported) as prophylaxis. The consumer stated his wife had been and was feeling well, happy and walking around. On 09-Oct-2025, the she began feeling tired, weak, achy, feverish (98.1 units not provided) and was in bed. The consumer was unable to provide brand names or other details regarding the flu or shingles vaccines nor was he able to provide any lot/expiration or dose information regarding his wife's pembrolizumab (KEYTRUDA). The consumer did provide feedback requesting clarifying information be added to available information clearly stating how long someone should wait to take other medications when taking pembrolizumab (KEYTRUDA). At the reporting time, the patient had not recovered from all the events. The action taken with pembrolizumab (KEYTRUDA) was reported as dose not changed. The patient did not seek medical attention. There was no treatment given for the events. Lab diagnostics were also reported as "mri, xray, cbc,ct scan" but without any results. The causal relationship between the events and pembrolizumab (KEYTRUDA) was unknown. The causal relationship between the events and Zoster Vaccine Live (manufacturer unknown) was unknown. The causal relationship between the events and sterile diluent (Hollister-Stier STERILE DILUENT) was unknown. The causal relationship between the events and Flu (Influenza vaccine) was unknown; Reporter's Comments: Keywords : OCL
Pancreatic cancer
Medical History/Concurrent Conditions: Surgery
gabapentin; KEYTRUDA; sterile diluent
Test Date: 20251009; Test Name: body temperature; Result Unstructured Data: feverish (98.1) and is in bed