Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| CHIK | CHIKUNGUNYA LIVE (IXCHIQ) | VALNEVA USA, INC. | UNK | — | — |
Rash (rash started faint, like raised bumps or pustules up the arm and down the legs); Brain Fog; Malaise; Did not feel like herself; High fever (38.9 degree Celsius); Headache; Light-headedness; Incredible joint pain, could not get up and down out of a chair; Debilitated; Felt achy; Positional nausea; Blood pressure went higher (140s systolic) because of the response to the NSAIDS; The following information was received from a nurse on 13 Mar 2025. A 72-year-old female vaccinee received one dose of IXCHIQ (Chikungunya virus vaccination (CHIKV), batch number not provided) into her left arm on 13 Feb 2025. Concomitant medication included Lipitor (atorvastatin), Allegra (fexofenadine), B12 (cobalamin), Tylenol ES as needed (acetaminophen), nasal spray for allergies (NOS), Benadryl (diphenhydramine, indication reported as for sleep [most likely sleep disorder]), and Zantac (ranitidine) for rash post vaccination. Relevant past medication included COVID vaccine Moderna. The vaccinee stated that she has no medical history with exception of borderline cholesterol. Relevant medical episodes included past medical history of COVID-19 immunisation, and brain fog (after COVID immunisation) and the current diseases/conditions borderline hypercholesterolaemia, sleeping disorder (NOS), as well as rash post vaccination (NOS). Approximately two days after vaccination ('15 Feb 2025 - 16 Feb 2025'), she experienced malaise. She 'did not feel like herself'. On 'approximately 18 Feb 2025 - 22 Feb 2025', she experienced high fever (38.9 degrees Celsius) along with headache and light headedness. Approximately five days post vaccination, she experienced 'incredible joint pain and could not get up and down out of a chair'. She had been debilitated for 24 hours, then it got better, and she just felt achy. This pain has lasted for approximately five days. On 21 Feb 2025 - 23 Feb 2025, the woman experienced nausea, when she laid down, stated as 'positional nausea', and took an Advil (ibuprofen) at night. However, her blood pressure went higher (140s systolic) reportedly 'because of the response to the NSAIDS'. On 26 Feb 2025, the vaccinee experienced a rash. The rash started faint, like raised bumps or pustules up the arm and down the legs. She also experienced brain fog, which was treated with Zantac (ranitidine) and Allegra (fexofenadine). Outcome in general was stated as '90% resolved' and outcome for brain fog was specifically stated as 'not resolved'. Case is linked to US-INTERCELLP-6750 (same reporter).; Sender's Comments: Company' medical assessment: This case refers to a 72-year-old female vaccinee who was vaccinated with IXCHIQ on 13 Feb 2025. After vaccination she experienced malaise, high fever, headache, light headedness, joint pain, asthenia, pain, nausea, elevated blood pressure, rash and brain fog. The causality of the reported events is assessed as possibly related to IXCHIQ, as time to onset is plausible (first events started 2 days past vaccination). The occurrence of all events can be seen in the context of a systemic vaccination reaction, but the relatively high age of the vaccinee, the sleep disorder and the concomitant medication, especially atorvastatin should be taken into consideration, too, as e.g. malaise, pyrexia, rash, dizziness, headache, pain, arthralgia, and asthenia are explicitly listed for atorvastatin.
Allergy NOS (Allergies); Borderline hypercholesterolaemia (Borderline cholesterol); Rash (Rash post vaccination)
Medical History/Concurrent Conditions: Brain fog (Brain Fog after her Moderna COVID shot); COVID-19 immunisation; Difficulty sleeping ("Sleep")
Lipitor; Allegra; B12; Tylenol ES; Benadryl; Zantac
Test Date: 202502; Test Name: Body temperature; Result Unstructured Data: High fever of 102ºF (38.9 degree Celsius); Test Date: 202502; Test Name: Blood pressure; Result Unstructured Data: (140s systolic) because of the response to the NSAIDS