Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Formication, Headache, Investigation, Magnetic resonance imaging, Noninfective encephalitis
Clinical narrative: brain infection/inflammation was really debilitating; C1 and C2 were slightly out of alignment; nothing stopped the prickly, crawling feeling in her brain.; nothing stopped the prickly, crawling feeling in her brain.; This brain inflammation was since 06Jul2022; inflammation of her brain membranes.; She had a viral brain infection; From the back of her head, up her occipital and up front of her face it was as if she had shingles on the inside with nothing showing on the outside. It was that intense and beyond painful; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 67 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Little high blood pressure", start date: 2015 (unspecified if ongoing), notes: Diagnosed 8 years ago, it's minor. Takes 5mg Benazepril every day.; "Migraine" (unspecified if ongoing), notes: Migraine Takes Sumatriptan; "Muscle spasms" (unspecified if ongoing), notes: She takes 50mg of Tramadol each day and Soma 350mg. A year ago, started on neurotoxin Botox.; "Severe Osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: BENAZEPRIL taken for hypertension (ongoing); SUMATRIPTAN taken for migraine; TRAMADOL taken for muscle spasms; SOMA [CARISOPRODOL] taken for muscle spasms; BOTOX taken for muscle spasms, start date: 2023. Past drug history included: Forteo for osteoporosis, reaction(s): "didn't do anything", notes: She did go through an 18 month program with Forteo, an injectable drug injected into abdomen, which didn't do anything.; Boniva for Osteoporosis, reaction(s): "it's totally useless", notes: She just lets them fill it and she doesn't take it. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: FD8448, Time: probably before noon; Anatomical Site of injection: usually in left arm, Route: injection), administration date: 20Aug2021, when the patient was 66-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: EL3302, Time: given before noon, Anatomical Site of injection: usually in the left arm; Route: injected), administration date: 05Mar2021, when the patient was 66-year-old, for COVID-19 immunization; BNT162b2 (DOSE 1, SINGLE; Lot number: EL3302, Anatomical Site of injection: Arm, Route: injection), administration date: 13Feb2021, when the patient was 66-year-old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 06Jul2022, outcome "recovering", described as "From the back of her head, up her occipital and up front of her face it was as if she had shingles on the inside with nothing showing on the outside. It was that intense and beyond painful"; ENCEPHALITIS VIRAL (medically significant) with onset 06Jul2022, outcome "recovering", described as "She had a viral brain infection"; NONINFECTIVE ENCEPHALITIS (medically significant) with onset 06Jul2022, outcome "recovering", described as "This brain inflammation was since 06Jul2022; inflammation of her brain membranes."; ASTHENIA (non-serious), outcome "unknown", described as "brain infection/inflammation was really debilitating"; DISLOCATION OF VERTEBRA (non-serious), outcome "unknown", described as "C1 and C2 were slightly out of alignment"; FORMICATION (non-serious), outcome "unknown", PARAESTHESIA (non-serious), outcome "not recovered" and all described as "nothing stopped the prickly, crawling feeling in her brain.". The patient underwent the following laboratory tests and procedures: Biopsy: (unspecified date) Unknown results, notes: They did biopsies and they were all benign, but did discover she had silicone in her lymph nodes from a breast implant. When that happened, who knows. She has really small breasts and was told to not go for more surgeries. Is scheduled to see for another ultrasound this month and another bone scan this month; Computerised tomogram: (unspecified date) Unknown results, notes: When she first started developing symptoms in her brain and skull, primary care immediately sent her in for a CAT scan or MRI. The scans definitely didn't show any type of masses or tumors or anything like that. Also had X-rays done to see if her cervical spine, C1 and C2 were out of alignment and possibly creating the symptoms. C1 and C2 were slightly out of alignment and the treatment she received did get her back in alignment; Investigation: (unspecified date) Unknown results, notes: They did biopsies and they were all benign, but did discover she had silicone in her lymph nodes from a breast implant. When that happened, who knows. She has really small breasts and was told to not go for more surgeries. Is scheduled to see for another ultrasound this month and another bone scan this month; Magnetic resonance imaging: (unspecified date) Unknown results, notes: They had done MRIs and there was no blockage, no masses. Went to neurologist who wanted to do a nerve block, but refused the nerve block because she wasn't in that type of pain; SARS-CoV-2 test: (19May2023) Negative, notes: First Test; (20May2023) Positive, notes: She took two more tests and at midnight on 20May2023, she was COVID-19 positive; X-ray: (unspecified date) Unknown results, notes: When she first started developing symptoms in her brain and skull, primary care immediately sent her in for a CAT scan or MRI. The scans definitely didn't show any type of masses or tumors or anything like that. Also had X-rays done to see if her cervical spine, C1 and C2 were out of alignment and possibly creating the symptoms. C1 and C2 were slightly out of alignment and the treatment she received did get her back in alignment. Therapeutic measures were taken as a result of noninfective encephalitis, encephalitis viral, headache, asthenia, dislocation of vertebra, formication.  Clinical course: She takes 50mg of Tramadol each day and Soma 350mg because she gets severe muscle spasms. Muscle spasms have been so severe over a 27-year period that finally, a year ago, some pain management doctor started injecting her with neurotoxin Botox to help keep those under control. She also has severe osteoporosis, which is shocking but not shocking because women get it all the time. She did go through an 18-month program with Forteo, an injectable drug injected into abdomen, which didn't do anything. NDC/LOT/EXP are unknown, this was about 8 years ago and [Name withheld] may be retired now. Now she's just taking Boniva, it's totally useless. She just lets them fill it and she doesn't take it. Caller wanted to tell the good side effects regarding Paxlovid. She had a viral brain infection. Once she took Paxlovid, it started helping with other issues she was already experiencing due to the brain infection. Paxlovid was like divine intervention. Doctors didn't know what brought this one, but it's been happening since 06Jul2022. Clarified she went to the dentist, and afterwards, something happened. From the back of her head, up her occipital and up front of her face it was as if she had shingles on the inside with nothing showing on the outside. It was that intense and beyond painful. She's fully vaccinated and hadn't had COVID. Then ended up getting COVID around 21May2023 and her doctor called in Paxlovid. Within 36 hours of taking Paxlovid, for the first time in a year, she had 80% relief from her symptoms. The best way she could describe was she was going through was an inflammation of her brain membranes. Wanted to tell Pfizer that Paxlovid can help other conditions besides COVID. This to her was a breakthrough. She had written 4 pages of notes of her experience. All of her COVID-19 Vaccines were manufactured by Pfizer. She didn't have any side effects with the vaccines. She eats really healthy has no cholesterol. Has slightly elevated blood pressure, but overall, she is healthy. Caller does everything via [withheld], except for examine and blood work. COVID-19 symptoms started 19May2023. First test was negative. She took two more tests and at midnight on 20May2023, she was COVID-19 positive. [Withheld], immediately called in Paxlovid. Started Paxlovid on 20May2023 or 21May2023, but was pretty sure it was Sunday, 21May2023. There was 80 percent relief from brain infection/inflammation symptoms. The symptoms from the brain infection/inflammation was really debilitating. She wanted to die. The COVID-19 was nothing. This brain infection/inflammation was since 06Jul2022. They had done MRIs and there was no blockage, no masses. Went to neurologist who wanted to do a nerve block, but refused the nerve block because she wasn't in that type of pain. The neurologist fired her as a patient. Confirmed caller was not suicidal and caller declined the phone number. Caller clarified she was just left in debilitating state with no answers and spent money on expensive doctors. She doesn't want to be treated like she was a bat-shit crazy person because she was highly educated and on her own figured out she has a viral inflammation in her brain because it follows the SARS and she had chicken pox. Her symptoms followed so much down that autoimmune type of area. She was spending $30,000 out of pocket a year and she wanted answers. Confirmed she completed the Paxlovid treatment and discarded the packaging. Can't remember time of COVID-19 Vaccines but pretty sure they were administered before noon. Thought her COVID-19 was pretty mild, but she was vaccinated and boosted. Thinks because of her age. In her opinion, COVID-19 has not gone away. States they stay up to date on the shingles and flu vaccine. Got the fifth COVID-19 Vaccine just to be proactive and because her husband is 77 and she is 68. Because she didn't have COVID-19, she hadn't built up any immunity because she hadn't had it. She's never had a cold in her life. She takes Alendronate sodium (Boniva) tablets USP 70mg tablet once a week. It doesn't create new bones. It hardens bones so if a person has a fall. She is part of an experimental [program name withheld]. When she first started developing symptoms in her brain and skull, primary care immediately sent her in for a CAT scan or MRI. The scans definitely didn't show any type of masses or tumors or anything like that. Also had X-rays done to see if her cervical spine, C1 and C2 were out of alignment and possibly creating the symptoms. C1 and C2 were slightly out of alignment and the treatment she received did get her back in alignment. But nothing stopped the prickly, crawling feeling in her brain. She doesn't know how relevant this is, but when she went for breast exam last year, she did have 3 small masses. They did biopsies and they were all benign, but did discover she had silicone in her lymph nodes from a breast implant. When that happened, who knows. She has really small breasts and was told to not go for more surgeries. She was scheduled to see for another ultrasound this month and another bone scan this month. Whatever Paxlovid did to her, is like winning money, it's a miracle. She was suffering, she was curled up in bed thinking she was going to die of a brain injury. When she gets back to [Place name withheld], [Name withheld] is doing a study long term COVID-19 and will be meeting with her to make her aware of caller's response to the Paxlovid. Once she completed Paxlovid, doctor put her on another anti-viral, Valacyclovir 1 gram tablet 3 times a day. After taking that for 48 hours, last night the inflammation in her head/brain came back with a vengeance to where she was hysterical. She called her neighbor who had some Paxlovid she didn't take. Caller got one dose of the 3 tablets, and within 1 hour and 45 minutes, her brain inflammation was over 80% gone. Caller was pretty savvy, and she doesn't mind being a guinea pig, but was in a debilitating state with her doctor for a year. It wasn't cool to do what she did, but states she is not talking about fentanyl or a street drug. This information could help hundreds or thousands of people. Her doctor was by the book. Caller stated she will take matters into her own hands and is not going back into a critical state, she was 103lbs and she was exhausted. Aware this was discrepant from caller previously providing she is 105 lbs, but this was confirmed and documented as provided. She would get her neighbor's Paxlovid again. If the symptoms come back again, she will call her friend across the street and get another dose of her Paxlovid. Stated it's scary is that it's an unknown variable. On normal COVID, she takes Paxlovid twice a day. She was experimenting. After she took Paxlovid last night, she woke up without the severe symptoms in her head, she is going to see how long she goes today with her symptoms being kept at bay. Then if the symptoms in her head come back tomorrow or the next day, she will get Paxlovid and will take another dose. This was vitally important. A a lot of drugs created for one condition and then down the road are found out to be wonderful for 4-5 other conditions. Her doctor wouldn't call in a second prescription of Paxlovid because it's not FDA approved beyond COVID-19. She was not going to let herself go back to feeling like she's going to die.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300211892 same patient and drug; different dose and event;