Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 5 | — | — |
Off balance -Fall down; Crying; Runny nose; High anxiety; Vertigo; Weakness; No smell; No Appetite; No taste; Coughing; vomit; This spontaneous case was reported by a patient and describes the occurrence of BALANCE DISORDER (Off balance -Fall down), CRYING (Crying), RHINORRHOEA (Runny nose), ANXIETY (High anxiety) and VERTIGO (Vertigo) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Previously administered products included for Product used for unknown indication: Pfizer (Dose 4, Batch no: GH9702) on 08-Nov-2022, Morphine and codeine. Past adverse reactions to the above products included No adverse effect with Pfizer; and Sickness with Morphine and codeine. Concurrent medical conditions included Drug allergy (Codeine made patient sick), Drug allergy (Morphine made patient sick), COVID-19 since 05-Jan-2020, High cholesterol since 10-Jun-1969, Post-traumatic stress disorder since 30-Nov-1970, Thyroid disorder since 15-Jun-1965, Stomach ache and Constipation. Concomitant products included Docusate sodium (Colace) from 01-Jan-2020 to an unknown date for Constipation, Calcium carbonate (Tums) from 01-Jan-2020 to an unknown date for Stomach ache. On 21-Nov-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced BALANCE DISORDER (Off balance -Fall down), CRYING (Crying), RHINORRHOEA (Runny nose), ANXIETY (High anxiety), VERTIGO (Vertigo), ASTHENIA (Weakness), ANOSMIA (No smell), DECREASED APPETITE (No Appetite), AGEUSIA (No taste), COUGH (Coughing) and VOMITING (vomit). At the time of the report, BALANCE DISORDER (Off balance -Fall down), CRYING (Crying), RHINORRHOEA (Runny nose), ANXIETY (High anxiety), VERTIGO (Vertigo), ASTHENIA (Weakness), ANOSMIA (No smell), DECREASED APPETITE (No Appetite), AGEUSIA (No taste), COUGH (Coughing) and VOMITING (vomit) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: blood pressure up. The events cause the patient to seek medical care. No other factors that could had led to the adverse event. The patient experienced similar events in past. No treatment information was reported. This case was linked to MOD-2025-782752 (Patient Link).; Reporter's Comments: Previously given Pfizer vaccination (unknown indication) can be contributing factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Constipation; COVID-19; Drug allergy (Morphine made patient sick); Drug allergy (Codeine made patient sick); High cholesterol; Post-traumatic stress disorder; Stomach ache; Thyroid disorder
Tums; Colace
Test Name: blood pressure; Result Unstructured Data: blood pressure up