Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Nasal disorder, Off label use, Pain in extremity, Rash
Clinical narrative: Beyond 42 days and No second dose yet; Rash (left  thigh); Shingles (left  thigh); Blisters (left  thigh); Numb Left Leg; Full Blown Allergy; Nasal symptoms; Cough; Tired; Left Arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles (left  thigh)), BLISTER (Blisters (left  thigh)), HYPOAESTHESIA (Numb Left Leg) and RASH (Rash (left  thigh)) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (Left Arm hurt) and FATIGUE (Tired). On 10-Apr-2021, the patient experienced HYPERSENSITIVITY (Full Blown Allergy), NASAL DISORDER (Nasal symptoms) and COUGH (Cough). On 16-Apr-2021, the patient experienced HERPES ZOSTER (Shingles (left  thigh)) (seriousness criterion medically significant), BLISTER (Blisters (left  thigh)) (seriousness criterion medically significant), HYPOAESTHESIA (Numb Left Leg) (seriousness criterion medically significant) and RASH (Rash (left  thigh)) (seriousness criterion medically significant). On 02-Jun-2021, the patient experienced OFF LABEL USE (Beyond 42 days and No second dose yet). On 16-Apr-2021, PAIN IN EXTREMITY (Left Arm hurt) had resolved. On 31-May-2021, HERPES ZOSTER (Shingles (left  thigh)), BLISTER (Blisters (left  thigh)), NASAL DISORDER (Nasal symptoms), COUGH (Cough) and FATIGUE (Tired) had resolved, HYPERSENSITIVITY (Full Blown Allergy) outcome was unknown. On 02-Jun-2021, OFF LABEL USE (Beyond 42 days and No second dose yet) had resolved. At the time of the report, HYPOAESTHESIA (Numb Left Leg) had not resolved and RASH (Rash (left  thigh)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product was not provided by the reporter  Patient reported that after taking vaccine her arm hurt and she was tired. On 10-Apr-2021 she had allergy, Cough, Nasal symptoms. She again had Rash, blister and diagnosed with shingles on left thigh. her left leg felt numb and feeling till at the time of report. Doctor advised her do not took 2nd dose until she has totally recovered.  Treatment information was not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Live follow up received on 02-Jun-2021.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.