Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis, Corneal lesion, Encephalitis, Herpes zoster, Hypokinesia
Clinical narrative: loss of consciousness; Transient encephalitis of brain; On Sunday she developed scabbing on her head and pink eye; Shingles got worse, swelling caused eyes to close/She had shingles on head eye neck; Pupil cornea lesion; Pink eye; She couldn't move, came to ER as code septic; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (loss of consciousness), ENCEPHALITIS (Transient encephalitis of brain), SCAB (On Sunday she developed scabbing on her head and pink eye), HERPES ZOSTER (Shingles got worse, swelling caused eyes to close/She had shingles on head eye neck), CORNEAL LESION (Pupil cornea lesion) and CONJUNCTIVITIS (Pink eye) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A, 010A21A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE, AMLODIPINE, ESCITALOPRAM, TORSEMIDE, ACETYLSALICYLIC ACID (ECOTRIN), POTASSIUM, ISOSORBIDE, UBIDECARENONE (COQ10 [UBIDECARENONE]), PROBIOTICS NOS, ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]) and PRAVASTATIN for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (loss of consciousness) (seriousness criteria hospitalization and medically significant), ENCEPHALITIS (Transient encephalitis of brain) (seriousness criteria hospitalization and medically significant), SCAB (On Sunday she developed scabbing on her head and pink eye) (seriousness criterion hospitalization), HERPES ZOSTER (Shingles got worse, swelling caused eyes to close/She had shingles on head eye neck) (seriousness criterion hospitalization), CORNEAL LESION (Pupil cornea lesion) (seriousness criterion hospitalization), CONJUNCTIVITIS (Pink eye) (seriousness criterion hospitalization) and HYPOKINESIA (She couldn't move, came to ER as code septic). The patient was treated with FAMCICLOVIR for Adverse reaction, at an unspecified dose and frequency and HEPARIN (intravenous) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (loss of consciousness), ENCEPHALITIS (Transient encephalitis of brain), SCAB (On Sunday she developed scabbing on her head and pink eye), HERPES ZOSTER (Shingles got worse, swelling caused eyes to close/She had shingles on head eye neck), CORNEAL LESION (Pupil cornea lesion) and CONJUNCTIVITIS (Pink eye) had not resolved and HYPOKINESIA (She couldn't move, came to ER as code septic) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took the IV Antibiotics, antiviral cream for eye and antibiotic cream for eye as treatment medication.  Company Comment: This case concerns an 89 year-old female patient with no reported medical history, on levothyroxine, amlodipine, torsemide, potassium, isosorbide, pravastatin who experienced the unexpected serious events of loss of consciousness, encephalitis, herpes zoster, conjunctivitis and corneal lesion. The events occurred on an unknown date in the same month as vaccination with the third dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns an 89 year-old female patient with no reported medical history, on levothyroxine, amlodipine, torsemide, potassium, isosorbide, pravastatin who experienced the unexpected serious events of loss of consciousness, encephalitis, herpes zoster, conjunctivitis and corneal lesion. The events occurred on an unknown date in the same month as vaccination with the third dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.