Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eye pruritus, Eye swelling, Fatigue, Feeling abnormal
Clinical narrative: Gave her an eye exam and was told that they were sore and swollen; felt like about to pass out; exhausted; rash on lower back of body; Broke out in deep red dots size of penny two on her left cheek one on upper calf; Itching in eyes; could not go to work; Headache; eyes red/pink eye; eyes swollen; freezing to death and could not stop being cold; terrible itching/itching on side of forehead/itching could not stop scratching; did not feel good; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 at 20:00 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine", start date: 2017 (ongoing), notes: Since she was a child. Neurologist in 2017 diagnosed her with migraines. She is on medication. Concomitant medication(s) included: AMITRIPTYLINE oral taken for migraine, start date: 2017 (ongoing). Vaccination history included: Moderna covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE, PRIMARY IMMUNIZATION SERIES COMPLETE), for COVID-19 immunization, reaction(s): "never had a thing/never had reaction"; Moderna covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "was not affected by the covid shot before not even boosters". The following information was reported: FEELING ABNORMAL (non-serious) with onset 27Sep2023, outcome "recovered with sequelae" (08Oct2023), described as "did not feel good"; PRURITUS (non-serious) with onset 27Sep2023, outcome "recovered" (03Oct2023), described as "terrible itching/itching on side of forehead/itching could not stop scratching"; FEELING COLD (non-serious) with onset 27Sep2023 at 20:30, outcome "recovered" (29Sep2023), described as "freezing to death and could not stop being cold"; HEADACHE (non-serious) with onset 28Sep2023, outcome "recovered" (02Oct2023); EYE PRURITUS (non-serious) with onset 28Sep2023, outcome "recovered" (07Oct2023), described as "Itching in eyes"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 28Sep2023, outcome "recovered" (12Oct2023), described as "could not go to work"; OCULAR HYPERAEMIA (non-serious) with onset 28Sep2023, outcome "recovered" (13Oct2023), described as "eyes red/pink eye"; EYE SWELLING (non-serious) with onset 28Sep2023, outcome "recovered" (13Oct2023), described as "eyes swollen"; RASH MACULAR (non-serious) with onset 30Sep2023, outcome "recovering", described as "Broke out in deep red dots size of penny two on her left cheek one on upper calf"; FATIGUE (non-serious) with onset 30Sep2023, outcome "recovered" (07Oct2023), described as "exhausted"; PRESYNCOPE (non-serious) with onset 30Sep2023, outcome "recovered" (07Oct2023), described as "felt like about to pass out"; RASH (non-serious) with onset 30Sep2023, outcome "recovering", described as "rash on lower back of body"; EYE PAIN (non-serious), outcome "unknown", described as "Gave her an eye exam and was told that they were sore and swollen". The events "terrible itching/itching on side of forehead/itching could not stop scratching", "freezing to death and could not stop being cold", "itching in eyes", "rash on lower back of body", "headache", "broke out in deep red dots size of penny two on her left cheek one on upper calf", "did not feel good", "could not go to work", "felt like about to pass out", "exhausted", "eyes red/pink eye", "eyes swollen" and "gave her an eye exam and was told that they were sore and swollen" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pruritus, feeling cold, eye pruritus, headache, rash macular, feeling abnormal, presyncope, fatigue, ocular hyperaemia, eye swelling. Therapeutic measures were not taken as a result of rash. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.  Additional information: patient reported did not have a sore throat, cough or sore arm where the shot was. . Had the Pfizer Covid 19 shot on Monday night and by Wednesday she was freezing to death and could not stop being cold for at least 48 hours (Put layer of clothes on and two down comforters by Saturday went to doctor because was miserable). Started itching on the side of her forehead and eye (put something on it does not know if it was Vaseline or A&D, she was at eye doctor on 04Oct2023 he gave her something. Had eye doctor's appointment on 16Oct2023, a follow up. ). By Friday, her eyes were swollen; had thought she had pink eye (Medication given by ophthalmologist). Woke up with a rash on the lower back of her body that her husband noticed on Saturday. Started getting a headache. Is prone to migraines and takes Amitryptline one pill at night. Broke out in deep red dots size of penny two on her left cheek one on upper calf (she was told to put Aquaphor on them). Had showed them to the doctor and was told that they should go away but they have not yet. One on the lower calf lightened but has not dissipated still colored to the skin. For the itching she bought cortisone cream and put that on. She was closed to passing out, she stayed in bed.