Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Vaccination failure
Clinical narrative: Flare up of her guillain-barre/Guillain-Barre syndrome; Headache; Having a hard time regulating her urine/the nurse thought she had a UTI on top of that; Kidney pain; Getting really hot then cold and hot and cold; Fever; Chest tightness; Flu; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history included: "Guillain Barre syndrome" (unspecified if ongoing), notes: Guillain Barre syndrome; "Myasthenia gravis" (unspecified if ongoing), notes: Myasthenia Gravis; "Hashimoto's disease" (unspecified if ongoing), notes: Hashimoto's disease; "over weight" (unspecified if ongoing); "Covid", start date: Mar2020 (unspecified if ongoing), notes: Had first symptoms of Covid Mar2020. Was having a Myasthenia flare up.; "Surgery", start date: Jun2022 (unspecified if ongoing), notes: Had surgery in Jun2022 and had more symptoms then. Concomitant medication(s) included: METHYLPREDNISOLONE taken for guillain-barre syndrome, myasthenia gravis (ongoing); TETANUS VACCINE taken for immunisation. Vaccination history included: Bnt162b2 (First Dose: Apr2021, she thinks, when they came out), administration date: Apr2021, when the patient was 52 years old, for COVID-19 immunization, reaction(s): "Has autonomic dysfunction", "Balance was off", "Flare up of Guillain-Barre", "After the first vaccine, her reflexes went away and that was it", "Her eyes, she had the miller fisher variant and her eyes got really wonky again"; Bnt162b2 (Dose 2), for COVID-19 immunization, reaction(s): "Flare up of Guillain-Barre", "Flare up of Guillain-Barre"; Bnt162b2 (Dose 3), for COVID-19 immunization, reaction(s): "Flare up of Guillain-Barre", "Flare up of Guillain-Barre". The following information was reported: INFLUENZA (non-serious) with onset 09Dec2022, outcome "unknown", described as "Flu"; CHEST DISCOMFORT (non-serious) with onset 12Dec2022, outcome "unknown", described as "Chest tightness"; GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "Flare up of her guillain-barre/Guillain-Barre syndrome"; HEADACHE (non-serious), outcome "unknown"; URINARY TRACT INFECTION (non-serious), outcome "unknown", described as "Having a hard time regulating her urine/the nurse thought she had a UTI on top of that"; RENAL PAIN (non-serious), outcome "unknown", described as "Kidney pain"; BODY TEMPERATURE FLUCTUATION (non-serious), outcome "unknown", described as "Getting really hot then cold and hot and cold"; PYREXIA (non-serious), outcome "unknown", described as "Fever". The events "flare up of her guillain-barre/guillain-barre syndrome", "flu", "headache", "chest tightness", "having a hard time regulating her urine/the nurse thought she had a uti on top of that", "kidney pain", "getting really hot then cold and hot and cold" and "fever" required emergency room visit. The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) Was getting really hot then cold and hot and cold., notes: Was spiking a fever; Full blood count: (unspecified date) Good, notes: Everything was good; Influenza: (09Dec2022) Positive, notes: Result: positive for Flu B; Unit: Not Provided; Metabolic function test: (unspecified date) Good, notes: Everything was good. Therapeutic measures were taken as a result of guillain-barre syndrome.  Clinical course: Caller states she received a pfizer bivalent covid vaccine at beginning of Nov this year. She was diagnosed with covid last friday. States 'with this vaccine and all others (unclear if received all pfizer covid 19 vaccines), she experienced a flareup of her guillain-barre. States before this she didnt have any symptoms for 30 years. States she started feeling sick so she received IBIG (gamma gard) last monday to thursday of last week. States she hasnt had IBIG for 30 yrs. Reports headache on the first day of IBIG treatment and reports infusion reaction. Last friday she was diagnosed with covid 19 and the flu. States she is 'feeling surprisingly well. She was prescribed paxlovid and was advised by her hcp if she became worse then she should start taking it. Reports chest tightness but hasnt started Paxlovid yet- she was not sure if she will take it. States she is unsure when her covid 19 infection sxs started as she had the flu and an infusion reaction. She was unsure whether the headache she experienced on the first day of IBIG infusion was related to covid 19 or infusion reaction. Her hcp informed her that the Paxlovid may not be effective if taken outside of the 5 day sxs onset window. Also reports her 'neuro is really flaring today." Also reports hx of Myasthenia Gravis; states it can flare with different medications. They did an IVIG, intravenous immunoglobulin treatment. She just finished the series last week. Clarified this treatment as the Gamma Gard infusion which was previously mentioned that she believes she had a reaction to. Wednesday, started having a hard time regulating her urine. Kept having to go and go and go. Was having kidney pain and was getting really hot then cold and hot and cold. Was spiking a fever so, the nurse thought she had a UTI on top of that.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.