Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sepsis, Urinary tract infection
Clinical narrative: Patient was feeling nauseous one day after receiving vaccine; As a result she wasn't drinking and became dehydrated; She complained of headache and back spasms which became progressively worse.; She complained of headache and back spasms which became progressively worse.; She was diagnosed with UTI, pneumonia and sepsis; pneumonia; sepsis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 92-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 92 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII taken for influenza immunisation as dose number unknown, single. The following information was reported: DEHYDRATION (hospitalization) with onset 17Oct2023, outcome "not recovered", described as "As a result she wasn't drinking and became dehydrated"; NAUSEA (hospitalization) with onset 17Oct2023, outcome "not recovered", described as "Patient was feeling nauseous one day after receiving vaccine"; HEADACHE (hospitalization), MUSCLE SPASMS (hospitalization) all with onset 17Oct2023, outcome "not recovered" and all described as "She complained of headache and back spasms which became progressively worse."; URINARY TRACT INFECTION (hospitalization) with onset 17Oct2023, outcome "not recovered", described as "She was diagnosed with UTI, pneumonia and sepsis"; PNEUMONIA (hospitalization) with onset 17Oct2023, outcome "not recovered"; SEPSIS (hospitalization) with onset 17Oct2023, outcome "not recovered". The patient was hospitalized for nausea, dehydration, headache, muscle spasms, urinary tract infection, pneumonia, sepsis (start date: 20Oct2023). The events "patient was feeling nauseous one day after receiving vaccine", "as a result she wasn't drinking and became dehydrated", "she complained of headache and back spasms which became progressively worse.", "she was diagnosed with uti, pneumonia and sepsis", "pneumonia" and "sepsis" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of nausea, dehydration, headache, muscle spasms, urinary tract infection, pneumonia, sepsis. Clinical course: Patient was feeling nauseous one day after receiving vaccine. As a result she wasn't drinking and became dehydrated. She complained of headache and back spasms which became progressively worse. She went to the ER on 20Oct2023 and was admitted. She was diagnosed with UTI, pneumonia and sepsis. Patient was treated with fluids and IV antibiotics. Remains hospitalized at this time. The patient's son, (name withheld), directly reported this to reporter. The treatment included: IV antibiotics and fluids. Patient did not had covid prior vaccination. Patient tested post vaccination and Covid test post vaccination result was Negative.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.