Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Vaccination site pain
Clinical narrative: cervical pain; lumbar, thoracic and cervical back pain; headache; fatigue; Nausea; sore arm at the injection site; I was diagnosed with shingles; Illness after 2nd dose; This spontaneous case was reported by a health care professional and describes the occurrence of HERPES ZOSTER (I was diagnosed with shingles), ILLNESS (Illness after 2nd dose), NECK PAIN (cervical pain), BACK PAIN (lumbar, thoracic and cervical back pain) and VACCINATION SITE PAIN (sore arm at the injection site) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Peripheral neuropathy hereditary.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced ILLNESS (Illness after 2nd dose). On 14-May-2021, the patient experienced HERPES ZOSTER (I was diagnosed with shingles). On 15-May-2021, the patient experienced VACCINATION SITE PAIN (sore arm at the injection site). On an unknown date, the patient experienced NECK PAIN (cervical pain), BACK PAIN (lumbar, thoracic and cervical back pain), HEADACHE (headache), FATIGUE (fatigue) and NAUSEA (Nausea). At the time of the report, HERPES ZOSTER (I was diagnosed with shingles) had not resolved, ILLNESS (Illness after 2nd dose), NECK PAIN (cervical pain), BACK PAIN (lumbar, thoracic and cervical back pain), HEADACHE (headache), FATIGUE (fatigue) and NAUSEA (Nausea) had resolved and VACCINATION SITE PAIN (sore arm at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered HERPES ZOSTER (I was diagnosed with shingles) and ILLNESS (Illness after 2nd dose) to be related. No further causality assessments were provided for NECK PAIN (cervical pain), BACK PAIN (lumbar, thoracic and cervical back pain), VACCINATION SITE PAIN (sore arm at the injection site), HEADACHE (headache), FATIGUE (fatigue) and NAUSEA (Nausea).    Concomitant products were included women multivitamin. Treatment medication were not reported/unknown.  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.   This case was linked to US-MODERNATX, INC.-MOD-2021-137830, US-MODERNATX, INC.-MOD-2021-138184 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: VAER form received events added, outcome of the event shingles updated, causality for the event illness and shingles was updated, dose 1 details received.; 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. US-MODERNATX, INC.-MOD-2021-137830:Same reporter US-MODERNATX, INC.-MOD-2021-138184:Same reporter, different patient