Sex: F
Vaccine: COVID19, FLUX, RVX
Symptoms: COVID-19, Gait inability, Guillain-Barre syndrome, Hypersensitivity, Loss of control of legs
Clinical narrative: leptomeningeal metastases; unable to control leg; Guillain barre; weird rash; Allergic reaction; Covid 19; swelling of the meninges; Unable to walk; difficulty with movement; This serious case was reported by a lawyer via other manufacturer and described the occurrence of leptomeningeal metastases in a female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (batch number HD9876) for prophylaxis and INFLUENZA VACCINE for prophylaxis.   Previously administered products included Pfizer Covid vaccine (1st dose received on 5th March 2021 lot number EN6201), Pfizer Covid vaccine (2nd dose received on 5th April 2021 lot number ER2613), Moderna covid vaccine (1st dose received on 2nd December 2021 lot number 058H21A), Moderna covid vaccine (2nd dose received on 2nd October 2022  lot number 061F22A) and Atovaquone. Concurrent medical conditions included brain swelling and allergy to antibiotic.   On 04-OCT-2023, the patient received RSV vaccine, PFIZER BIONTECH COVID-19 VACCINE and INFLUENZA VACCINE. In OCT-2023, 2 weeks after receiving RSV vaccine, the patient experienced movement disorder (Verbatim: difficulty with movement). On 07-NOV-2023, the patient experienced meningitis (Verbatim: swelling of the meninges) (serious criteria GSK medically significant). In NOV-2023, the patient experienced unable to walk (Verbatim: Unable to walk). On 19-JUL-2024, the patient experienced covid-19 (Verbatim: Covid 19). On an unknown date, the patient experienced leptomeningeal metastases (Verbatim: leptomeningeal metastases) (serious criteria GSK medically significant), loss of control of legs (Verbatim: unable to control leg) (serious criteria GSK medically significant), guillain barre syndrome (Verbatim: Guillain barre) (serious criteria GSK medically significant), rash (Verbatim: weird rash) and allergic reaction (Verbatim: Allergic reaction). The outcome of the leptomeningeal metastases, loss of control of legs, guillain barre syndrome, meningitis, unable to walk and movement disorder were not reported and the outcome of the covid-19 was not resolved and the outcome of the rash and allergic reaction were resolved.   It was unknown if the reporter considered the leptomeningeal metastases, loss of control of legs, guillain barre syndrome, meningitis, unable to walk, movement disorder, covid-19, rash and allergic reaction to be related to RSV vaccine.     The company considered the leptomeningeal metastases, loss of control of legs, guillain barre syndrome and meningitis to be unrelated to RSV vaccine. It was unknown if the company considered the unable to walk, movement disorder, covid-19, rash and allergic reaction to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 30-JUL-2024 The patient stated that she called regarding a request for Paxlovid that was denied and then added different information. Caller stated 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 04 October 2023. The next month in November, she was sent to the Emergency department because she could not walk. The agent thought the caller said she had 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 stated it was that she was having issues with not being able to control her leg but she could walk at point, corrected the information provided to state she went in there and the initial diagnosis was that she had swelling of the meninges and they thought she had leptomeningeal metastases and she has had 200 various tests run and stated she did not have cancer anywhere but had 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 reason called was because she came up positive for covid on day of reporting and her doctor had called in Paxlovid that the insurance company flagged as having some high reaction or bad reaction to atovaquone but had previously taken that and stopped taking it in May. Patient stated her weight was right around 100 pounds. The first dose was on 05 March 2021 Pfizer Covid vaccine, EN6201, had no expiry dates or NDC numbers to provide on her card, the next dose was on 05 April 2021 and was Pfizer Covid vaccine with lot number ER2613, the next dose was 02 December 2021 and was Moderna with lot number 058H21A, the next dose was 17 October 2022 and was Moderna with lot number 061F22A, the next was 04 October 2023 and was Pfizer covid vaccine with lot number HD9876 and then she stopped. RSV Vaccine had no lots, expiry dates, NDC number or manufacturer name for any of the components to provide. Flu vaccine had no manufacturer name, lot, expiry date or NDC number to provide. Paxlovid had no lot, expiry date, NDC to provide because the doctor who prescribed it had the pharmacist flag it and the caller called Pfizer and they said it was a bad reaction with Atovaquone that she took when she went on prednisone to release the swelling in her brain and they put her on this Atovaquone.  She was allergic to Bactrim, for the Atovaquone and Bactrim, stated she had a box that had never been opened and the manufacturer of those was camber and she assumed it was the same manufacturer as the other one. Stated she was not a Healthcare professional but was a lawyer. The movement issued began she wanted to say around like 10 to 14 days after the vaccines. No concomitant medications and did not even take an aspirin. Other medical conditions were she did 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. Investigations reported were that she had probably 200 test results and those results just showed swelling in the meninges and that began on November 7th. She went to the Emergency room 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 was. She asked if she was ok to get Paxlovid, the previous agent stated they could not find the drug that the insurance flagged as having a bad reaction, caller aware this agent had no information to speak. There was a product complaint to reported that she came up positive for covid on day of reporting. It was unknown if the company considered the leptomeningeal metastases, loss of control of legs, guillain barre syndrome, meningitis, unable to walk, movement disorder, covid-19 and rash to be related to pfizer biontech covid-19 vaccine and influenza vaccine.; Sender's Comments: Metastases to meninges, Loss of control of legs,  Guillain Barre syndrome and  Meningitis are unlisted events which are considered unrelated to GSK RSV vaccine.