Sex: F
Vaccine: COVID19
Symptoms: Herpes ophthalmic, Hidradenitis, Scab, Wound haemorrhage
Clinical narrative: Herpes ocular/Three herpes outbreaks in left eye; Hidradenitis suppurativa/Hidradenitis outbreaks on buttocks and left thigh; Scab/Hole in left leg with wound/scab on top of it was full of blood; Wound bleeding; This spontaneous case was reported by a consumer and describes the occurrence of HERPES OPHTHALMIC (Herpes ocular/Three herpes outbreaks in left eye) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Previously administered products included for Product used for unknown indication: Keflex. Past adverse reactions to the above products included No adverse event with Keflex. Concurrent medical conditions included Allergy to antibiotic (Keflex allergy) and Rheumatoid arthritis. Concomitant products included FAMOTIDINE, BACLOFEN, TRAZODONE, THIAMINE HYDROCHLORIDE, FENOFIBRATE, SPIRONOLACTONE, METHOTREXATE, HYDROXYCHLOROQUINE PHOSPHATE (PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]), VARENICLINE TARTRATE (CHANTIX), DOXYCYCLINE, DOXYCYCLINE HYCLATE (HYCLATE), HYDROXYZINE and CELECOXIB (CELEBREX) for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient experienced HERPES OPHTHALMIC (Herpes ocular/Three herpes outbreaks in left eye) (seriousness criterion medically significant), HIDRADENITIS (Hidradenitis suppurativa/Hidradenitis outbreaks on buttocks and left thigh), SCAB (Scab/Hole in left leg with wound/scab on top of it was full of blood) and WOUND HAEMORRHAGE (Wound bleeding). At the time of the report, HERPES OPHTHALMIC (Herpes ocular/Three herpes outbreaks in left eye), HIDRADENITIS (Hidradenitis suppurativa/Hidradenitis outbreaks on buttocks and left thigh), SCAB (Scab/Hole in left leg with wound/scab on top of it was full of blood) and WOUND HAEMORRHAGE (Wound bleeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 vaccine trial.   On unknown dates, the patient experienced hidradenitis outbreaks on buttocks and left thigh, hole in left leg with wound/scab on top of It was full of blood and three herpes outbreaks in left eye.  Moderna was also considered suspect.   No treatment medication was 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.  Company Comment: This is a spontaneous case concerning an adult female patient with no relevant medical history, who experienced the unexpected, serious event of Herpes ophthalmic (reported as three herpes outbreaks in left eye), after receiving the first dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the outbreaks, clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an adult female patient with no relevant medical history, who experienced the unexpected, serious event of Herpes ophthalmic (reported as three herpes outbreaks in left eye), after receiving the first dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the outbreaks, clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.