Sex: F
Vaccine: COVID19
Symptoms: Throat tightness, Vertigo, Vomiting
Clinical narrative: now has persistent vertigo; Throat closing; vomiting; This is a spontaneous report received from a Pharmacist and an Other HCP.  A 50-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergic to wheat and rye products" (ongoing); "Asthma" (ongoing); "IBS" (unspecified if ongoing); "Anaphylaxis" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "allergies" (unspecified if ongoing); "breast cancer surgery" (not ongoing), notes: had chemo 2007 and had surgery 2006/2007 and had been cancer free since.; "non smoker" (unspecified if ongoing); "Breast cancer", start date: 2006 (not ongoing); "Chemotherapy", start date: 2007 (not ongoing). Concomitant medication(s) included: CLARITIN [LORATADINE]; SYNTHROID taken for hypothyroidism. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EJ1685), administration date: 18Dec2020, when the patient was 47-year-old, for COVID-19 Immunization, reaction(s): "allergic reaction", "throat was closing up", "vomiting uncontrollably/vomiting constantly", "had normal achiness", "very lightheaded and dizzy", "splitting migraine", "tiredness", "had the weird sensation in her head"; BNT162b2 (DOSE 2, SINGLE, Lot: EJ1685), administration date: 08Jan2021, when the patient was 47-year-old, for COVID-19 Immunization, reaction(s): "allergic reaction", "throat was closing up", "blood pressure spiked up", "felt nauseous", "inner ear disorder", "flu like symptoms", "achiness", "headache", "vertigo", "couldn't walk, she was walking sideways", "faint"; BNT162b2 (DOSE 2, SINGLE, Lot: EJ1685), administration date: 21Aug2021, when the patient was 47-year-old, for COVID-19 Immunization, reaction(s): "Vomiting", "allergic reaction", "normal achiness", "headache", "a little nausea"; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Lot: FM0698), administration date: 25Mar2022, when the patient was 48-year-old, for COVID-19 Immunization, reaction(s): "throat was closing up", "allergic reaction", "asthma", "normal achiness", "headache", "nausea"; moderna (DOSE 5 (BOOSTER), SINGLE, Lot: A89140C), administration date: 29Sep2022, when the patient was 49-year-old, for COVID-19 Immunization. The following information was reported: VERTIGO (disability, medically significant), outcome "not recovered", described as "now has persistent vertigo"; THROAT TIGHTNESS (medically significant), outcome "unknown", described as "Throat closing"; VOMITING (medically significant), outcome "unknown". Therapeutic measures were taken as a result of vertigo. Clinical course: She got another COVID Vaccination & now had persistent vertigo with no other obvious causes. She did learn she was allergic to wheat and rye products (reaction: anaphylaxis). Patient was not hospitalized, not admitted to an Intensive care unit and did not display clinical signs at rest indicative of severe systemic illness. Patient did not require supplemental oxygen (Including high flow or ECMO) or receive mechanical ventilation. Event required the initiation of new medication or other treatment or procedure of Ginger for treatment of vertigo s/p COVID shot. Patient did not have COVID and not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 Vaccination. Ginger root capsules 550 mg up to 4/day. 5x from Pfizer 2019. Reporter considered the Pfizer product had a causal effect to the adverse event.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: A possible contribution of suspect drug BNT162B2 OMI XBB.1.5 cannot be totally excluded for the reported events given the compatible time association. However, patient underlying medical history may be a confounder. Case will be reassessed should additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.,Linked Report(s) : US-PFIZER INC-202400052538 Same patient/product, different dose/events;US-PFIZER INC-202400051629 Same patient/product, different dose/events;US-PFIZER INC-202400051079 Same patient/product, different dose/events;US-PFIZER INC-202400051628 Same patient/product, different dose/events;