Received Apr 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | 1 | LP1776 | OT / LA |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | 1 | UT8485MA | OT / LA |
hallucinations; reaction of chills, shakes; reaction of chills, shakes; extreme headache; Initial information received on 16-Apr-2025 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional. This was a courtesy case received via Pfizer. This case involves a 45 years old female patient who experienced hallucinations, reaction of chills, shakes, reaction of chills, shakes and extreme headache after receiving Covid-19 Vaccine (Comirnaty) and Influenza usp trival a-b subvirion no preservative vaccine [Fluzone]. The patient's past medical history included Dyspepsia. The patient's past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Ergocalciferol (Vitamin d); Ethinylestradiol, Levonorgestrel (Simpesse); Omeprazole; Hepatitis b vaccine rHBsAg (yeast) (Heplisav b); Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Tdap); and Typhoid vaccine (Typhoid) for Immunisation. On 08-Apr-2025, the patient received a dose 1 of suspect influenza usp trival a-b subvirion no preservative vaccine Suspension for injection lot UT8485MA via unknown route in the left arm (route, strength and expiration date: not provided) for prophylactic vaccination and received a dose 1 of suspect COVID-19 Vaccine (Comirnaty) not produced by Sanofi Pasteur lot LP1776 via unknown route in the left arm (route, strength and expiration date: not provided) for prophylactic vaccination. On 09-Apr-2025 the patient developed hallucinations (hallucination), reaction of chills, shakes (chills), (tremor) and headache (latency- 1 day). Reportedly, patient stated that she had her normal reaction of chills, shakes, etc, but after that stopped an extreme headache has settled that has lasted since 4/9. Was having mild hallucinations the first couple days, not being fully aware of where she was. Action taken- not applicable (for both suspects). The patient was treated with Butalbital, Caffeine, Paracetamol (Fioricet) for Symptomatic treatment. At time of reporting, the outcome was Not Recovered / Not Resolved for all the events. Seriousness criteria- medically significant for hallucination.; Sender's Comments: Sanofi Company Comment dated 23-Apr-2025: This case involves a 45 years old female patient who experienced hallucinations, reaction of chills, shakes, reaction of chills, shakes and extreme headache after receiving Covid-19 Vaccine (Comirnaty) and Influenza usp trival a-b subvirion no preservative vaccine [Fluzone]. The causal role of the company suspect vaccine cannot be assessed based on the temporal relevance. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Medical History/Concurrent Conditions: Heartburn
Vitamin d; Simpesse; Omeprazole; Heplisav b; Tdap; Typhoid