Received Apr 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | LP1776 | LA |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | 1 | UT8485MA | LA |
mild hallucinations; disassociation/not being fully aware of where she was; an extreme headache has settled that has lasted since 09Apr2025; chills; shakes; This is a spontaneous report received from a Consumer or other non HCP. A 45-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 08Apr2025 at 15:00 as dose 1, single (Lot number: LP1776), in left arm for covid-19 immunisation; influenza vaccine (FLUZONE [INFLUENZA VACCINE]), on 08Apr2025 as dose 1, single (Lot number: UT8485MA), in left arm for immunisation. The patient's relevant medical history included: "Just occasional heartburn" (unspecified if ongoing). Concomitant medication(s) included: HEPLISAV B taken for immunisation, on 01Apr2025 as dose 2, single; TDAP taken for immunisation, on 01Apr2025 as dose 1, single; TYPHOID VACCINE POLYSACCH VI taken for immunisation, on 01Apr2025 as dose 1, single; VITAMIN D NOS, start date: 26Mar2025; SIMPESSE, start date: 27Mar2025; OMEPRAZOLE, start date: 04Apr2024. Vaccination history included: Heplisav b (Dose 1), for Immunization. The following information was reported: CHILLS (non-serious) with onset 09Apr2025, outcome "recovered" (09Apr2025); TREMOR (non-serious) with onset 09Apr2025, outcome "recovered" (09Apr2025), described as "shakes"; HEADACHE (non-serious) with onset 09Apr2025 at 13:00, outcome "not recovered", described as "an extreme headache has settled that has lasted since 09Apr2025"; DISSOCIATION (non-serious) with onset 09Apr2025 at 13:00, outcome "recovered" (Apr2025), described as "disassociation/not being fully aware of where she was"; HALLUCINATION (medically significant) with onset 09Apr2025 at 13:00, outcome "not recovered", described as "mild hallucinations". The events "mild hallucinations", "disassociation/not being fully aware of where she was" and "an extreme headache has settled that has lasted since 09apr2025" required emergency room visit. Therapeutic measures were taken as a result of hallucination, dissociation, headache. Clinical details: The next morning after taking the two vaccines, she had her normal reaction of chills, shakes, etc, but after that stopped an extreme headache has settled that has lasted since 09Apr2025. She was having mild hallucinations the first couple days, not being fully aware of where she was. Went to urgent care, they prescribed Fioricet, which has stopped the disassociation, but has not touched the actual headache. The patient had none known allergies.
Medical History/Concurrent Conditions: Heartburn
VITAMIN D NOS; SIMPESSE; OMEPRAZOLE