Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Head discomfort, Heart rate, Heart rate irregular, Insomnia
Clinical narrative: I thought I may have developed GBS or MS; I thought I may have developed GBS or MS; I had a raised, hot, tender welt on the deltoid muscle; Burning sensations on my scalp/face/neck/thighs/shins/ankles; Tingling all over my body/Pins & needles sensations in my hands/feet/legs; Hip joint pain; Blurred vision; Fullness sensation in my ears & head; Fullness sensation in my ears & head; Occipital/trigeminal neuralgia pains shooting from my neck & above my ears to my eyes/face; Occipital/trigeminal neuralgia pains shooting from my neck & above my ears to my eyes/face; Random extreme dizzy spells; Difficulty concentrating; Insomnia; Fluctuating heart rate & blood pressure; fluctuating heart rate & blood pressure; Difficulty breathing; Numerous GI issues (acid reflux/GERD); Intense pains from my right shoulder blade to my spine that seem to be gallbladder related.; Intense pains from my right shoulder blade to my spine that seem to be gallbladder related.; Intense pains from my right shoulder blade to my spine that seem to be gallbladder related.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 at 12:00 as dose 5 (booster), single (Lot number: GJ5342) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HSV2" (unspecified if ongoing); "Hashimotos" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "Herniated Discs" (unspecified if ongoing); "Known allergies: Eggs" (unspecified if ongoing); "Known allergies: Hazelnuts" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing). Concomitant medication(s) included: B12-VITAMIIN; D3; OMEPRAZOLE; LIVALO; VALACYCLOVIR [VALACICLOVIR]; SYNTHROID. Past drug history included: Amoxicillin for Drug allergy; Ibuprofen for Drug allergy; Lactose for Drug allergy. Vaccination history included: BNT162b2 (Dose Number: 4, Batch/Lot No: FM9992, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 04Jun2022, when the patient was 54-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 3, Batch/Lot No: FJ1620, Location of injection: Arm Left, Vaccine Administration Time: 04:30 PM), administration date: 27Nov2021, when the patient was 53-year-old, for COVID-19 immunization, reaction(s): "Lab Notes:Nasal Swab/Result:Positive", "Lab Notes:Nasal Swab/Result:Positive"; BNT162b2 (Dose Number: 2, Batch/Lot No: EN5318, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 10Apr2021, when the patient was 52-year-old, for COVID-19 immunization, reaction(s): "migraines"; BNT162b2 (Dose Number: 1, Batch/Lot No: EP7534, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 20Mar2021, when the patient was 52-year-old, for COVID-19 immunization, reaction(s): "I had burning tongue syndrome beforehand", "severe lightheadedness/dizziness", "it has gotten much worse", "Tinnitus", "weakness in my left arm", "severe headache", "Nausea". The following information was reported: VISION BLURRED (disability) with onset 2022, outcome "not recovered", described as "Blurred vision"; BURNING SENSATION (disability) with onset 2022, outcome "not recovered", described as "Burning sensations on my scalp/face/neck/thighs/shins/ankles"; DYSPNOEA (disability) with onset 2022, outcome "not recovered", described as "Difficulty breathing"; DISTURBANCE IN ATTENTION (disability) with onset 2022, outcome "not recovered", described as "Difficulty concentrating"; HEART RATE IRREGULAR (disability) with onset 2022, outcome "not recovered", described as "Fluctuating heart rate & blood pressure"; HEAD DISCOMFORT (disability), EAR DISCOMFORT (disability) all with onset 2022, outcome "not recovered" and all described as "Fullness sensation in my ears & head"; ARTHRALGIA (disability) with onset 2022, outcome "not recovered", described as "Hip joint pain"; VACCINATION SITE URTICARIA (disability) with onset 2022, outcome "not recovered", described as "I had a raised, hot, tender welt on the deltoid muscle"; INSOMNIA (disability) with onset 2022, outcome "not recovered"; BILIARY COLIC (disability), MUSCULOSKELETAL PAIN (disability), SPINAL PAIN (disability) all with onset 2022, outcome "not recovered" and all described as "Intense pains from my right shoulder blade to my spine that seem to be gallbladder related."; GASTROOESOPHAGEAL REFLUX DISEASE (disability) with onset 2022, outcome "not recovered", described as "Numerous GI issues (acid reflux/GERD)"; TRIGEMINAL NEURALGIA (disability), OCCIPITAL NEURALGIA (disability) all with onset 2022, outcome "not recovered" and all described as "Occipital/trigeminal neuralgia pains shooting from my neck & above my ears to my eyes/face"; DIZZINESS (disability) with onset 2022, outcome "not recovered", described as "Random extreme dizzy spells"; PARAESTHESIA (disability) with onset 2022, outcome "not recovered", described as "Tingling all over my body/Pins & needles sensations in my hands/feet/legs"; BLOOD PRESSURE FLUCTUATION (disability) with onset 2022, outcome "not recovered", described as "fluctuating heart rate & blood pressure"; GUILLAIN-BARRE SYNDROME (disability, medically significant), MULTIPLE SCLEROSIS (disability, medically significant), outcome "unknown" and all described as "I thought I may have developed GBS or MS". The events "i had a raised, hot, tender welt on the deltoid muscle", "burning sensations on my scalp/face/neck/thighs/shins/ankles", "tingling all over my body/pins & needles sensations in my hands/feet/legs", "hip joint pain", "blurred vision", "fullness sensation in my ears & head", "occipital/trigeminal neuralgia pains shooting from my neck & above my ears to my eyes/face", "random extreme dizzy spells", "difficulty concentrating", "insomnia", "fluctuating heart rate & blood pressure", "fluctuating heart rate & blood pressure", "difficulty breathing", "numerous gi issues (acid reflux/gerd)" and "intense pains from my right shoulder blade to my spine that seem to be gallbladder related." required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Angiogram: Unknown Results; Blood cholesterol: High; Blood pressure measurement: fluctuating; Blood test: Unknown Results; Catheterisation cardiac: Unknown Results; Computerised tomogram: Unknown Results; Heart rate: fluctuating; Magnetic resonance imaging: Unknown Results; Ultrasound scan: Unknown Results; X-ray: Unknown Results. Therapeutic measures were taken as a result of vaccination site urticaria, burning sensation, paraesthesia, arthralgia, vision blurred, head discomfort, ear discomfort, trigeminal neuralgia, occipital neuralgia, dizziness, disturbance in attention, insomnia, heart rate irregular, blood pressure fluctuation, gastrooesophageal reflux disease, biliary colic, musculoskeletal pain, spinal pain.  Clinical course: After the 5th dose, patient had a raised, hot, tender welt on the deltoid muscle where the vaccine was administered. A few days later she began having (and still had ) intense symptoms that became so extreme, she was bedridden for 3 weeks (she thought she might had developed GBS or MS). In addition to the above mentioned symptoms, she now also had burning sensations on her scalp/face/neck/thighs/shins/ankles tingling all over my body, pins & needles sensations in her hands/feet/legs, hip joint pain blurred vision, fullness sensation in her ears & head, occipital/trigeminal neuralgia pains shooting from her neck & above her ears to her eyes/face, random extreme dizzy spells, difficulty concentrating, insomnia, fluctuating heart rate & blood pressure, difficulty breathing and numerous GI issues (acid reflux/GERD) intense pains from her right shoulder blade to her spine that seem to be gallbladder related. Patient did not received any other vaccine in 4 weeks. Patient did not had Covid prior vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300253122 same reporter/patient/product, different dose/event;US-PFIZER INC-2021367791 same reporter/patient/product, different dose/event;