Received Dec 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | — | — |
| PPV | PNEUMO (PNEUMOVAX) | MERCK & CO. INC. | UNK | — | — |
| PPV | PNEUMO (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| PPV | PNEUMO (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
did not feel well; feeling really bad; nausea; chills; fever; COVID 19; Gait disturbance; lymphadenopathy; nail disorder; cardiac disorder; Asthenia; arthralgia; This spontaneous report was received from referring to an 82-year-old female patient. The patient's past medical history, medical treatments, concomitant drugs/ vaccinations, and family history were not provided. The patient had the unspecified history of vaccination reaction before. Since 2024, the patient started taking doxycycline salt (strength, dose, route of administration, lot#, expiration date, and indication were not reported). On an unknown date in 2025, the patient initiated taking dupilumab (DUPIXENT) solution for injection (unknown strength; 300 mg: 3 doses of 300 mg) subcutaneously for Prurigo Nodularis and Bullous pemphigoid. On 02-OCT-2025, the patient was vaccinated with pneumococcal vaccine (manufacturer unknown) (strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis; and the patient was vaccinated with COVID-19 VACCINE (strength, dose, route of administration, lot#, and expiration date were not reported). After getting the vaccination, on 02-OCT-2025, the patient did not feel well (intermittent constant nausea), fever, chills, freezing cold last night and just feeling really bad. On an unknown date in October 2025, the patient felt weakness which made walking around 1,000 times worse in the morning and at night (conflicting information, the onset date was also reported as an unknown date in 2024, after the vaccination of pneumococcal vaccine). On an unknown date in October 2025, the patient developed cardiac disorder, swollen lymph nodes, change in fingernails, joint pain, COVID 19. The patient had no problems with dupilumab (DUPIXENT). The patient's pharmacist told her to wait 2472 hours for the dupilumab (DUPIXENT), so it would be late. The action taken with doxycycline, and dupilumab (DUPIXENT) and doxycycline was unknown. At the time of reporting, the patient had not recovered from nausea, asthenia, gait disturbance, cardiac disorder, lymphadenopathy, arthralgia. The outcome of the remaining events was unknown. The reporter considered the events of feeling unwell, nausea, fever, chills, and feeling abnormal were related to the suspected vaccines. The causal relationship between the remaining events and pneumococcal vaccine was not provided. This case was received from the same reporter with another case. Lot# is being requested and will be submitted if received.; Sender's Comments: Priority : 2 , Is case serious : Yes , Index user : Index date : 2025-12-17 , MNSC number : 02920698 , CLIC number : , ESTAR number : , IRMS number : 2025SA29695 , Central date : 2025-12-15 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Medical History/Concurrent Conditions: Vaccination adverse reaction
DUPIXENT; doxycycline salt