Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pruritus, Rash
Clinical narrative: Hasn't been able to sleep in the last two days; Severe allergic reaction; Body is flush; Burning sensation in her body; Body reddish; Eruption all over their body, and it moving to their groin area; Got itchiness on their body,all of their body got horrible; Doctor recommended to wait 3 month to take their second dose; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Severe allergic reaction), PRURITUS (Got itchiness on their body, all of their body got horrible), FLUSHING (Body is flush), INSOMNIA (Hasn't been able to sleep in the last two days), BURNING SENSATION (Burning sensation in her body), ERYTHEMA (Body reddish) and RASH (Eruption all over their body, and it moving to their groin area) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ROSUVASTATIN for an unknown indication.   On 08-Apr-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, the patient experienced PRURITUS (Got itchiness on their body,all of their body got horrible) (seriousness criterion hospitalization) and OFF LABEL USE (Doctor recommended to wait 3 month to take their second dose). On 29-Aug-2021, the patient experienced FLUSHING (Body is flush) (seriousness criterion hospitalization), BURNING SENSATION (Burning sensation in her body) (seriousness criterion hospitalization), ERYTHEMA (Body reddish) (seriousness criterion hospitalization) and RASH (Eruption all over their body, and it moving to their groin area) (seriousness criterion hospitalization). On an unknown date, the patient experienced HYPERSENSITIVITY (Severe allergic reaction) (seriousness criterion hospitalization) and INSOMNIA (Hasn't been able to sleep in the last two days) (seriousness criterion hospitalization). The patient was treated with METHYLPREDNISOLONE SODIUM SUCCINATE (METHYLPRED) on 27-Aug-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (Severe allergic reaction), PRURITUS (Got itchiness on their body,all of their body got horrible), FLUSHING (Body is flush), INSOMNIA (Hasn't been able to sleep in the last two days), BURNING SENSATION (Burning sensation in her body), ERYTHEMA (Body reddish), RASH (Eruption all over their body, and it moving to their groin area) and OFF LABEL USE (Doctor recommended to wait 3 month to take their second dose) outcome was unknown.            Additional treatment medication included was Allergy relief medication.  On 27 Aug 2021, all of their body got horrible, and patient went to the hospital. Patient never had an allergic reaction in their entire life.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This is a case of Off label dosing frequency. Further information will be requested to clarify if patient was hospitalized due to the events associated with second dose administered.   This case was linked to MOD-2021-300936 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This is a case of Off label dosing frequency. Further information will be requested to clarify if patient was hospitalized due to the events associated with second dose administered.