Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Herpes zoster, Product dose omission issue, Skin burning sensation
Clinical narrative: temperature; swelling of the face; missed dose; severe headache; shingles; burning on the right side of her stomach and around the back; she noticed a lesion under her right breast; This spontaneous case was reported by a nurse and describes the occurrence of SKIN BURNING SENSATION (burning on the right side of her stomach and around the back), SKIN LESION (she noticed a lesion under her right breast), HERPES ZOSTER (shingles), BODY TEMPERATURE (temperature) and SWELLING FACE (swelling of the face) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) injection for an unknown indication.    No Medical History information was reported.   In 2019, the patient started DUPILUMAB (DUPIXENT) (unknown route) 1 dosage form.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.   On 12-Oct-2020, the patient experienced SKIN BURNING SENSATION (burning on the right side of her stomach and around the back) and SKIN LESION (she noticed a lesion under her right breast). On 19-Oct-2020, the patient experienced HERPES ZOSTER (shingles). On an unknown date, the patient experienced BODY TEMPERATURE (temperature), SWELLING FACE (swelling of the face), PRODUCT DOSE OMISSION ISSUE (missed dose) and HEADACHE (severe headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) ongoing since an unknown date for Skin lesion, at an unspecified dose and frequency and ACYCLOVIR [ACICLOVIR] for Shingles and Skin lesion, at an unspecified dose and frequency. At the time of the report, SKIN BURNING SENSATION (burning on the right side of her stomach and around the back), BODY TEMPERATURE (temperature), SWELLING FACE (swelling of the face), PRODUCT DOSE OMISSION ISSUE (missed dose) and HEADACHE (severe headache) outcome was unknown and SKIN LESION (she noticed a lesion under her right breast) and HERPES ZOSTER (shingles) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: Body temperature abnormal.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 11-Oct-2020, the patient did an injection in her abdomen.  It was reported that the corrective treatment dry up the lesion that was about the size of a silver dollar with blisters (blister). It was painful (pain) and burning (skin burning sensation) felt like somebody burned it and wiped it raw. Patient went to the emergency room on  19-Oct-2020 and they diagnosed her with shingles .  Patient was not sure if she received a loading dose or not.  No product technical complaint (PTC) was reported for the event missed dose.   No relevant medical history was reported for the patient.    Concomitant medication was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.