Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Interchange of vaccine products, Nausea
Clinical narrative: Hives from her shoulders down to her feet/Welts on her waistband; itching on her lower back; skin rash/a little rash on her left feet; vomited; nausea (queasy); shake and chills followed by non-shaking chills after; shake and chills followed by non-shaking chills after; fatigue; headache; interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 78 years for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 02May2023 as dose 6 (booster), single (Lot number: 069H22A) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: HTN controlled with medicines; "Dizzy" (unspecified if ongoing), notes: Cipro which made her dizzy. The patient's concomitant medications were not reported. Past drug history included: Ciprofloxacin, reaction(s): "Dizzy". Vaccination history included: moderna coviD-19 vaccine (Dose 1, Single, Lot number: 025L20A), administration date: 22Jan2021, when the patient was 76-year-old, for Covid-19 Immunization; moderna coviD-19 vaccine (Dose 2, Single, Lot number: 011A21A), administration date: 26Feb2021, when the patient was 77-year-old, for Covid-19 Immunization; moderna coviD-19 vaccine (Dose 3 (Booster), Single, 1st Booster, Lot number: 033F21A), administration date: 01Nov2021, when the patient was 77-year-old, for Covid-19 Immunization; moderna coviD-19 vaccine (Dose 4 (Booster), Single, 2nd Booster, Lot number: 057M21A), administration date: 02May2022, when the patient was 78-year-old, for Covid-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 26Nov2022, outcome "unknown"; NAUSEA (non-serious) with onset 05May2023, outcome "recovered", described as "nausea (queasy)"; TREMOR (non-serious), CHILLS (non-serious) all with onset 05May2023, outcome "recovered" and all described as "shake and chills followed by non-shaking chills after"; VOMITING (non-serious) with onset 05May2023, outcome "recovered", described as "vomited"; RASH (non-serious) with onset 09May2023, outcome "recovered", described as "skin rash/a little rash on her left feet"; URTICARIA (non-serious) with onset 10May2023, outcome "recovered", described as "Hives from her shoulders down to her feet/Welts on her waistband"; PRURITUS (non-serious) with onset 10May2023, outcome "recovered", described as "itching on her lower back"; FATIGUE (non-serious) with onset May2023, outcome "recovered"; HEADACHE (non-serious) with onset May2023, outcome "recovered". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash, urticaria, pruritus.  Additional information: Caller experienced adverse reaction upon receiving bivalent booster dose on 02May2023. Caller advised that she suffered from nausea and shaking chills on 05May2023 and broke out in hives on skin rash on 10May23. The caller advised her HCP treated her hives and rash with a prescription cream. Caller advised that she was administered Pfizer vaccine booster on 21Oct2022. The caller was a retired nurse practitioner who reported the following details of the adverse events she experienced after getting the Moderna bivalent on 02May2023. She stated that she was fine after getting the shot but on 05May2023 she vomited once, and this was followed by 5 days of nausea (queasy) but did not have fever at all. On 16- 18May2023, she had shake and chills and this was followed by non-shaking chills after. On 07May2023, she tested negative for Covid. On 09May2023, she noted a little rash on her left feet, but she disregarded it. On 10May2023, when she woke up, she had hives from her shoulders down to her feet. She noticed welts on her waistband and there was itching on her lower back. She consulted with her primary physician and was prescribed with tapering Prednisone (she was still on it at the time of the call) for 5 days and Triamcinolone to help with the itching. The hives disappeared after 2 days she was on Prednisone. She had fatigue and headache but very mild. No bruising noted. She did not have any concomitant vaccines administered with the 2nd bivalent booster. She had her flu shot in the fall of last year.  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.