Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersomnia, Malaise, Ocular hyperaemia, Pain of skin
Clinical narrative: eyes were reddened with crusty discharge from eye drops which contain the propylene glycol; skin tenderness; skin tenderness and redness; eyes were reddened with crusty discharge from eye drops which contain the propylene glycol; eyes were reddened with crusty discharge from eye drops which contain the propylene glycol; not feeling well/general malaise; excessive sleeping/fatigue; decreased appetite/low appetite; excessive sleeping/fatigue; headache; the skin at the injection site which was at the left arm was red and was itching; the skin at the injection site which was at the left arm was red and was itching; This spontaneous case was reported by a nurse practitioner and describes the occurrence of EYELID MARGIN CRUSTING (eyes were reddened with crusty discharge from eye drops which contain the propylene glycol), MALAISE (not feeling well/general malaise), HYPERSOMNIA (excessive sleeping/fatigue), DECREASED APPETITE (decreased appetite/low appetite) and PAIN OF SKIN (skin tenderness) in an adult female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Adverse drug reaction NOS, Lichen sclerosis atrophicus and Colonoscopy in 2015. Previously administered products included for Lichen sclerosis atrophicus: CLOBETASOL (0.05% skin cream with propylene glycol); for Product used for unknown indication: systane ultra (night time), ESTRADIOL (Estradiol vaginal cream (topical medicine), ,) called Patagis 0.01 % for dermatologic issues.) and MIRALAX. Past adverse reactions to the above products included No adverse effect with CLOBETASOL, ESTRADIOL and systane ultra; and Sickness with MIRALAX. Concurrent medical conditions included Sjogren's.    On 26-Jan-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. In January 2025, the patient experienced VACCINATION SITE PRURITUS (the skin at the injection site which was at the left arm was red and was itching) and VACCINATION SITE ERYTHEMA (the skin at the injection site which was at the left arm was red and was itching). On 26-Jan-2025,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced MALAISE (not feeling well/general malaise), HYPERSOMNIA (excessive sleeping/fatigue), DECREASED APPETITE (decreased appetite/low appetite), FATIGUE (excessive sleeping/fatigue) and HEADACHE (headache). On an unknown date, the patient experienced EYELID MARGIN CRUSTING (eyes were reddened with crusty discharge from eye drops which contain the propylene glycol), PAIN OF SKIN (skin tenderness), ERYTHEMA (skin tenderness and redness), OCULAR HYPERAEMIA (eyes were reddened with crusty discharge from eye drops which contain the propylene glycol) and EYE DISCHARGE (eyes were reddened with crusty discharge from eye drops which contain the propylene glycol). In January 2025, VACCINATION SITE PRURITUS (the skin at the injection site which was at the left arm was red and was itching) and VACCINATION SITE ERYTHEMA (the skin at the injection site which was at the left arm was red and was itching) had resolved. At the time of the report, EYELID MARGIN CRUSTING (eyes were reddened with crusty discharge from eye drops which contain the propylene glycol), MALAISE (not feeling well/general malaise), HYPERSOMNIA (excessive sleeping/fatigue), DECREASED APPETITE (decreased appetite/low appetite), PAIN OF SKIN (skin tenderness), ERYTHEMA (skin tenderness and redness), OCULAR HYPERAEMIA (eyes were reddened with crusty discharge from eye drops which contain the propylene glycol), EYE DISCHARGE (eyes were reddened with crusty discharge from eye drops which contain the propylene glycol), FATIGUE (excessive sleeping/fatigue) and HEADACHE (headache) was resolving.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   Patient was using eyedrops because of Sjogrems for both eyes. When she stopped using it her eyes got better.  Patient took a laxative MiraLax for the very first time and then really felt sick afterwards. MiraLax she took back in 2015 which had propylene glycol.  It was reported that patient went to pick it up and looked at the ingredients and said, I did not think I want this one because of the trouble I had before, and because of the trouble with the eye drops and the trouble with the skin cream. Patient had the trouble with propylene glycol was with MiraLax first time. Patient used Clobetasol for Lichen Sclerosis, which was getting worse, a skin cream with propylene glycol. She had stopped it, and a biopsy was done after seeing her dermatologist and found out it was not Lichen Sclerosis but was something else. Patient reported that it was not treating the lichen sclerosis when it had treated it for, like 25 years that it had been working. The brand was Taro.  It was reported that the patient had reactions post administration of the Moderna vaccine. She was not feeling well afterwards. She added she felt fine after the first ones. She reported that she cannot tolerate creams, or eye drops with it as well as MiraLax with propylene glycol.  The symptoms were mild to moderate headache, general malaise, excessive sleeping/fatigue, decreased appetite/low appetite, all occurred by evening on the same day or 4 hours afterwards.  All these symptoms were a little worse the next day but a little better today but still present. Patient then clarified she did not react to the vaccine, but she reacted to propylene glycol dermatologically with skin tenderness and redness. Patient never had a local reaction but the skin at the injection site which was at the left arm was red and was itching. Patient took the band aid off on Sunday night. But today injection site was fine. Today no longer itching and red.  No treatment medication was reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.