Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypotension, Inappropriate schedule of product administration, Overdose, Presyncope, SARS-CoV-2 test
Clinical narrative: Dizziness; hearing and inners ear/hearing aid in Jun/hearing in my left ear was (decreased symbol) by 40%; BP changes; 2 falls at home; near syncopy episode; weak; low bp; Date of start of drug: 27Jun2023, Dose Number: 6; Date of start of drug: 27Jun2023, Dose Number: 5; Date of start of drug: 27Jun2023, Dose Number: 6; Date of start of drug: 27Jun2023, Dose Number: 5; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Jun2023 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm and on 27Jun2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes type 2, A16. 5.5." (unspecified if ongoing), notes: 10 chronic conditions; "mod elevated BP" (unspecified if ongoing); "arthritis of spine knees" (unspecified if ongoing); "torn rotator cuff" (unspecified if ongoing); "2x spinal fusions", start date: 2016 (unspecified if ongoing), notes: 2x spinal fusions 2016 and 2019 for spinal stenosis and sciatica; "Fibromyalgia" (unspecified if ongoing); "weight loss of 80 lbs in 14 years" (unspecified if ongoing); "leaky heart valves" (unspecified if ongoing), notes: Heart valve leakage with last echo; "spring allergies" (unspecified if ongoing); "kidney disease" (unspecified if ongoing), notes: Stage III; "Penicillin allergy" (unspecified if ongoing); "myalgias" (unspecified if ongoing), notes: some cholesterol meds cause myalgias; "milk and fish together very serious allergy" (unspecified if ongoing); "milk and fish together very serious allergy" (unspecified if ongoing); "Anemia of long duration" (unspecified if ongoing); "Fall 11 total so far since 1985", start date: 1985 (unspecified if ongoing); "Gout right foot" (unspecified if ongoing), notes: Controlled; "Artificial right total knee" (unspecified if ongoing), notes: Artificial right total knee use cane since 2016; "Artificial right total knee" (unspecified if ongoing), notes: Artificial right total knee use cane since 2016; "arthritis of spine knees, arm, both hand, feet" (unspecified if ongoing); "arthritis of spine knees, arm, both hand, feet" (unspecified if ongoing); "arthritis of spine knees, arm, both hand, feet" (unspecified if ongoing); "spinal stenosis and sciatica" (unspecified if ongoing); "spinal stenosis and sciatica" (unspecified if ongoing); "Weak left leg" (unspecified if ongoing). Concomitant medication(s) included: CELEBREX (ongoing); LOSARTAN (ongoing); MG [MAGNESIUM SULFATE] (ongoing); HCTZ (ongoing); NEXIUM [ESOMEPRAZOLE SODIUM] (ongoing). Vaccination history included: Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Manufacturer: Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer: Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer: Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer: Unknown), for Covid-19 immunization. The following information was reported: OVERDOSE (non-serious), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) all with onset 27Jun2023, outcome "unknown" and all described as "Date of start of drug: 27Jun2023, Dose Number: 6; Date of start of drug: 27Jun2023, Dose Number: 5"; DIZZINESS (hospitalization) with onset 15Aug2023, outcome "not recovered"; HYPOACUSIS (hospitalization) with onset Aug2023, outcome "not recovered", described as "hearing and inners ear/hearing aid in Jun/hearing in my left ear was (decreased symbol) by 40%"; HYPOTENSION (non-serious) with onset 08Sep2023, outcome "not recovered", described as "low bp"; PRESYNCOPE (medically significant) with onset 08Sep2023, outcome "not recovered", described as "near syncopy episode"; ASTHENIA (non-serious) with onset 08Sep2023, outcome "not recovered", described as "weak"; FALL (non-serious), outcome "unknown", described as "2 falls at home"; BLOOD PRESSURE ABNORMAL (non-serious), outcome "unknown", described as "BP changes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Aug2023) Negative, notes: Nasal Swab; (unspecified date) Negative. Therapeutic measures were taken as a result of hypoacusis, dizziness, presyncope, asthenia, hypotension. Therapeutic measures were not taken as a result of fall.  Clinical information: Her 6th and last Covid shot was 27Jun2023, they returned from cruise on 05Aug, it has been 10 month since her last shot. Her attending doctor wanted her to wait until after her surgery on 02May2024. They have been trying to find out what was causing the dizziness and balance issues. Since Aug, she has communicated with her cardiologist regarding her BP changes and BP med evaluation as she did not have dizziness until mid Aug2023. Her EKG appeared normal and was on a home monitor for 1 week. There was no cardiac arrhythmia or extra beats noted - just dizziness according to her doctor. Tests were done after her near syncopy on 08Sep2023. She finally had the ENT consult on 26Mar2023 and will have a follow up with another doctor in Jun. Found out from her audiogram that hearing in her left ear was (decreased "symbol") by 40% which she noticed in Aug combined with the dizziness probably led to middle ear which could indicate the falls. An MRI was done which said 7th cranial nerve was intact and ears were clear, she will follow-up with possible hearing aid in Jun. Some days her dizziness was better by afternoon, she believed in the Pfizer shots as she has had no problems except after the one on 27Jun2023. MRI head was done.  Follow-up (26Apr2024): Follow-up attempts are completed.  Follow up (07May2024): This is a spontaneous follow up report from a same consumer. This consumer (patient) reported in response to Non-HCP letter sent in cross reference case included that: Updated information: Case upgraded to serious, additional events, medical history, laboratory data, concomitant medication details, lot number removed and clinical course details.  Batch/lot number is not provided, and it cannot be obtained.