Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Pruritus, Sluggishness, Tongue disorder, Vaccination site pain
Clinical narrative: thickening of my tongue; itchy; lower intestines rumbled; arms felt heavy; Patient has not had second dose; Thowing up/Threw up that night; Felt like boiling water pouring down arm; Super tired; Felt dizzy; Arm and fingers felt sluggish for the day; Horrible migraine; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISORDER (thickening of my tongue), PRURITUS (itchy), GASTROINTESTINAL SOUNDS ABNORMAL (lower intestines rumbled), LIMB DISCOMFORT (arms felt heavy) and DIZZINESS (Felt dizzy) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Allergy NOS (History of bad allergies (unspecified)).    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced DIZZINESS (Felt dizzy), SLUGGISHNESS (Arm and fingers felt sluggish for the day), MIGRAINE (Horrible migraine), VOMITING (Thowing up/Threw up that night), VACCINATION SITE PAIN (Felt like boiling water pouring down arm) and FATIGUE (Super tired). On an unknown date, the patient experienced TONGUE DISORDER (thickening of my tongue), PRURITUS (itchy), GASTROINTESTINAL SOUNDS ABNORMAL (lower intestines rumbled), LIMB DISCOMFORT (arms felt heavy) and PRODUCT DOSE OMISSION ISSUE (Patient has not had second dose). On 26-Jan-2021, MIGRAINE (Horrible migraine) and FATIGUE (Super tired) had resolved. At the time of the report, TONGUE DISORDER (thickening of my tongue), PRURITUS (itchy), GASTROINTESTINAL SOUNDS ABNORMAL (lower intestines rumbled), LIMB DISCOMFORT (arms felt heavy), DIZZINESS (Felt dizzy), SLUGGISHNESS (Arm and fingers felt sluggish for the day), VOMITING (Thowing up/Threw up that night) and VACCINATION SITE PAIN (Felt like boiling water pouring down arm) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient has not had second dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant medications and treatment information was not provided. The patient has not gotten the second dose.  She is afraid of having the second dose.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Based on the current available information and strong temporal association between the use of the product and the start date of the event, and excluding all other etiologies, a causal relationship cannot be excluded. Tiredness, vaccination site pain and vomiting are consistent with the known safety profile of the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: Follow-up information received captured additional adverse events, medical history and reporter details.; Reporter's Comments: Based on the current available information and strong temporal association between the use of the product and the start date of the event, and excluding all other etiologies, a causal relationship cannot be excluded. Tiredness, vaccination site pain and vomiting are consistent with the known safety profile of the vaccine.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.