Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, FLUX, RVX, COVID19, FLUX, RVX
Symptoms: COVID-19, Investigation, SARS-CoV-2 test, Vaccination failure, Weight
Clinical narrative: rash; has swelling in her meninges of her brain/swelling on her brain; had a difficulty/she could not walk; This is a spontaneous report received from a Consumer or other non HCP from medical information team and product quality group.  A 62-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Oct2023 as dose 1, single (Lot number: HD9876) at the age of 62 years for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 04Oct2023 as dose number unknown, single) for immunisation; rsv vaccine (RSV VACCINE), on 04Oct2023 as dose number unknown, single) for immunisation. The patient's relevant medical history included: "leptomeningeal metastases" (unspecified if ongoing); "Guilian barre" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1 Pfizer Covid vaccine, lot number EN6201), administration date: 05Mar2021, when the patient was 60-year-old, for Covid-19 immunization; BNT162b2 (Dose 2 Pfizer Covid vaccine with lot number ER2613), administration date: 05Apr2021, when the patient was 60-year-old, for Covid-19 immunization; moderna (Dose 3 Moderna with lot number 058H21A.), administration date: 02Dec2021, when the patient was 60-year-old, for Covid-19 immunization; moderna (Dose 4  Moderna with lot number 061F22A.), administration date: 17Oct2022, when the patient was 61-year-old, for Covid-19 immunization. The following information was reported: BRAIN OEDEMA (medically significant) with onset 07Nov2023, outcome "unknown", described as "has swelling in her meninges of her brain/swelling on her brain"; GAIT INABILITY (non-serious) with onset Nov2023, outcome "unknown", described as "had a difficulty/she could not walk"; RASH (non-serious), outcome "recovered". The event "had a difficulty/she could not walk" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: she came up positive for covid today. Clinical course: Caller on the line who is the patient and she states she called regarding a request for Paxlovid that was denied and then added different information. Caller states she had a difficulty with movement that began 2 weeks after took the covid vaccine, RSV vaccine, and flu shot that she had all in one day back in October on 04Oct2023. The next month in November, she was sent to the ER because she could not walk. The USMI agent thinks the caller said she has metastatic brain cancer and the cancer did cause the difficulty in movement as they ruled that out and they do not know why there was swelling on her brain. Caller clarified the information provided and states it was that she was having issues with not being able to control her leg but she could walk at point. She went in there and the initial diagnosis was that she has swelling of the meninges and they thought she had leptomeningeal metastases and she has had 200 various tests run and has been to MD and states she does not have cancer anywhere but has swelling in her meninges of her brain and so a couple of weeks after she took this she had weird leg movements and got progressively worse and clarified she has never had Paxlovid. The movement issue began she wants to say around like 10-14 days after the vaccines. She does not know but has had this weird rash that developed and they never knew what that was but it went away and resolved when all the movements issues started when she started having difficulty with movements. The rash was on her trunk and they said it looked like she had an allergic reaction to medication but she was not on any medication. MD and those results just showed swelling in the meninges and that began 07Nov; she went to the ER because she was having difficulty controlling her leg and wants to say it was the right leg and then it became both and just progressed to the point she was not able to walk or control her trunk and thought she had Guillain barre or whatever that is.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400220362 same patient, different dose/AE;