Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: dizziness; vomiting; vertigo/vesicular vertigo; arm swelling; had a little bit of an reaction / got the booster on 09Oct2021 and reports that one was awful; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swelling), VERTIGO (vertigo/vesicular vertigo), DIZZINESS (dizziness) and VOMITING (vomiting) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 1301A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Macular degeneration (under control with medication that it had been taking for years and years and years.) since 2020, Blood pressure high (under control with medication that it had been taking for years and years and years.) and High cholesterol (under control with medication that it had been taking for years and years and years.).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Oct-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced PERIPHERAL SWELLING (arm swelling) (seriousness criterion hospitalization). On 01-Dec-2022, the patient experienced VERTIGO (vertigo/vesicular vertigo) (seriousness criterion hospitalization). On an unknown date, the patient experienced DIZZINESS (dizziness) (seriousness criterion hospitalization), VOMITING (vomiting) (seriousness criterion hospitalization) and IMMUNISATION REACTION (had a little bit of an reaction / got the booster on 09Oct2021 and reports that one was awful). The patient was treated with MECLOZINE (MECLIZINE [MECLOZINE]) ongoing from 01-Dec-2022 for Dizziness and Vertigo, at a dose of 3 a day and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intravenous) ongoing since an unknown date for Dizziness and Vomiting, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (arm swelling), VERTIGO (vertigo/vesicular vertigo), DIZZINESS (dizziness), VOMITING (vomiting) and IMMUNISATION REACTION (had a little bit of an reaction / got the booster on 09Oct2021 and reports that one was awful) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood potassium: low potassium because they think she vomited all of the food up..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. All blood tests were normal only. When they took her by ambulance to the hospital, they did a CAT scan and X-ray. All of a sudden on 01-Dec-2022 caller got vertigo and ended up in the hospital and they said it was vesicular vertigo and nobody could figure out why they got this. Caller just came from the eye doctor who mentioned the vesicular vertigo and she started looking it up and came across an article by Moderna saying it had been linked with the vaccine. Caller had not been to an ENT doctor but have been referred. They gave her Benadryl while she was in the hospital.  Company comment: This is a spontaneous case concerning a 82-year-old female patient with blood pressure high, who experienced the serious (hospitalization) unexpected events vertigo, dizziness and vomiting. On 01-Dec-2022, more than one year after the last reported dose of mRNA-1273 (Booster dose on 09-Oct-2021), patient experienced vertigo and had gone to the hospital by ambulance. Blood test showed low potassium (attributed to vomiting). CAT scan and X-ray was performed without reported results. It was said she had "vesicular" vertigo, and was treated with meclizine, Benadryl IV and other medications to stop the dizziness and vomiting. Further information had been requested. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: Company comment: This is a spontaneous case concerning a 82-year-old female patient with blood pressure high, who experienced the serious (hospitalization) unexpected events vertigo, dizziness and vomiting. On 01-Dec-2022, more than one year after the last reported dose of mRNA-1273 (Booster dose on 09-Oct-2021), patient experienced vertigo and had gone to the hospital by ambulance. Blood test showed low potassium (attributed to vomiting). CAT scan and X-ray was performed without reported results. It was said she had "vesicular" vertigo, and was treated with meclizine, Benadryl IV and other medications to stop the dizziness and vomiting. Further information had been requested. The benefit-risk relationship of mRNA-1273 is not affected by this report.