Received Dec 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | LA |
Chills; between chills and warm; Dizziness; Headache; a bit of brain fog; Was not severe pain, but was noticeable, where she had shot in left arm, was mild pain, in upper left arm; This is a spontaneous report received from a Consumer or other non HCP. A 59-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 12Dec2025 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "lupus" (unspecified if ongoing), notes: Takes lupus medication. The patient took concomitant medications. Vaccination history included: Covid 19 vaccine (DOSE 1, unknown manufacturer), for covid-19 immunization; Covid 19 vaccine (DOSE 2, unknown manufacturer), for covid-19 immunization; Covid 19 vaccine (DOSE 3, unknown manufacturer), for covid-19 immunization; Flu shot (unknown manufacturer ), administration date: 2025, for immunization. The following information was reported: CHILLS (non-serious) with onset 13Dec2025, outcome "recovered"; DIZZINESS (non-serious) with onset 13Dec2025, outcome "recovered"; HEADACHE (non-serious) with onset 13Dec2025, outcome "recovered"; VACCINATION SITE PAIN (non-serious) with onset 13Dec2025, outcome "recovered", described as "Was not severe pain, but was noticeable, where she had shot in left arm, was mild pain, in upper left arm"; BRAIN FOG (non-serious) with onset 13Dec2025, outcome "recovered", described as "a bit of brain fog"; FEELING HOT (non-serious) with onset 13Dec2025, outcome "recovered", described as "between chills and warm". Therapeutic measures were taken as a result of chills, feeling hot, dizziness, headache. Additional information: Reporter called regarding Pfizer Covid vaccine, had that Friday. Thinks she kind of experienced some side effects, which could happen. Age adverse event was same age, 59. Just had this, last Friday. Knows she has had 3 Covid vaccines before. Not sure if ones she had before were Pfizer or not, does not remember. Patient clarified she thinks, maybe 10 hours later, after getting Covid vaccine, clarified, as Friday, 13Dec2025. Has chills, can kind of get warm, fluctuates between chills and warm. Has some dizziness, that has kind of coming and going. Also had a little bit of a headache, not horrible, not awful, just enough to let her know she has a headache, guesses, a light headache. Yesterday, started to figure, was tied to Covid shot. Tried Aleve but, that is not working. Thinks Aleve can last up to 12 hours, did not see that with Alleve. Has a bit of brain fog. Was not severe pain, but was noticeable, where she had shot in left arm, was mild pain, in upper left arm. Does have lupus, goes to see lupus doctor, rheumatologist, to be proactive, to get any next shots for flu and pneumonia, told to be proactive. Had flu shots 2 months before, from same place. Just watching closely, to see how she is feeling. This happened a few times over weekend, kind of went away. Feels ok right now. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
Medical History/Concurrent Conditions: Lupus erythematosus (Takes lupus medication)