Age: 77.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Balance disorder, Blister, Condition aggravated, Dizziness, Fatigue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), BLISTER (blister), BALANCE DISORDER (off balance/dropped things and broke things and knocked into things), CONDITION AGGRAVATED (symptoms are getting worse/itching got worse) and DIZZINESS (dizzy) in a 77-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product THYROID (ARMOUR THYROID) for an unknown indication.    Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Two instances of the body itch years ago. The First was after encountering some jelly fish. Her whole body was a rash but she went to her doctor for it. The second instance was a rash she experiences at a football game years ago.  The patient's past medical history included Itching all over (Two instances of the body itch years ago. The First was after encountering some jelly fish. Her whole body was a rash but she went to her doctor for it. The second instance was a rash she experiences at a football game years ago.) and COVID-19. Previously administered products included for Product used for unknown indication: Influenza Vaccine; for COVID-19 prophylaxis: COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE and Influenza Vaccine.   On 17-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient started THYROID (ARMOUR THYROID) (unknown route) at an unspecified dose. In December 2022, the patient experienced PRURITUS (itching). On an unknown date, the patient experienced BLISTER (blister), BALANCE DISORDER (off balance/dropped things and broke things and knocked into things), CONDITION AGGRAVATED (symptoms are getting worse/itching got worse), DIZZINESS (dizzy), FATIGUE (felt tired) and RASH (rash/larger rash that is reoccurring /broke out in a rash all over their body). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, PRURITUS (itching), BLISTER (blister), DIZZINESS (dizzy) and RASH (rash/larger rash that is reoccurring /broke out in a rash all over their body) had not resolved and BALANCE DISORDER (off balance/dropped things and broke things and knocked into things), CONDITION AGGRAVATED (symptoms are getting worse/itching got worse) and FATIGUE (felt tired) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported.  Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine Her doctor told her to call and report her side effects. She had a small rash and then escalated to itching and larger rash that is reoccurring and symptoms are getting worse. She had itching and a rash after receiving the Moderna COVID-19 Bivalent vaccine. She had all vaccines. The itching got worse in December through holidays. They broke out in a rash all over their body. she visited the doctor they said the rash was due to the Bivalent vaccine. The doctor treated with her with Prednisone. The caller said they get flare -ups. They also take Amour Thyroid medicine and has been taking it for 20 years. She started to eliminate food and started deep cleaning to rule out environmental reasons and determined it was the Bivalent vaccine she received. She felt dizzy and off balance, she dropped things and broke things and knocked into things. The beginning of January she went to urgent care and the doctor didn't know what it was. They referred her to a dermatologist. She went several days later, and he said he saw patients like this who experience this from any vaccine (not necessarily Moderna). They received prednisone and it seemed to go away. She would get these big flare ups at night. She stopped her Armour Thyroid and then recently she got a compound to use instead to see if it may be from this medication.   This case was linked to US-MODERNATX, INC.-MOD-2023-708304 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-708304:Other Patients case