Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Insomnia, Polymers allergy, Rash, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH (Terrible rash which kept her awake at night) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 037BZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Glaucoma (Patient said the medication for rash affected her glaucoma with increased eye pressure). On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced ARTHRALGIA (Severe shoulder pain which it went away in a week). On 23-Oct-2021, the patient experienced RASH (Terrible rash which kept her awake at night) (seriousness criterion medically significant), INSOMNIA (Terrible rash which kept her awake at night) and ARTHRALGIA (severe shoulder pain returned). On 30-Dec-2021, the patient experienced COVID-19 (Covid-19) and DRUG INEFFECTIVE (Lack of Drug Effect). On an unknown date, the patient experienced POLYMERS ALLERGY (several allergies such as plastic/polyester), ALLERGY TO METALS (nickel allergy), ALLERGY TO CHEMICALS (Dye allergy) and HYPERSENSITIVITY (fragrance allergy). The patient was treated with HYDROCORTISONE (CORTIZONE 10) at an unspecified dose and frequency. At the time of the report, RASH (Terrible rash which kept her awake at night), COVID-19 (Covid-19), DRUG INEFFECTIVE (Lack of Drug Effect), POLYMERS ALLERGY (several allergies such as plastic/polyester), INSOMNIA (Terrible rash which kept her awake at night), ALLERGY TO METALS (nickel allergy), ALLERGY TO CHEMICALS (Dye allergy) and HYPERSENSITIVITY (fragrance allergy) outcome was unknown, ARTHRALGIA (severe shoulder pain returned) was resolving and ARTHRALGIA (Severe shoulder pain which it went away in a week) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive. No Concomitant Medications were provided by the Reporter. Patient visited the Dermatologist and was prescribed with Cortizone 10 which initially did not help, later steroid cream was prescribed by HCP which seemed to help relieving the pain. Company comment: This spontaneous case concerns a 60 year old female patient with no relevant medical history reported, who experienced Serious (Medically significant), unexpected event of Rash which occurred 5 months and 16 days post vaccination with the 2nd dose of mRNA-1273 vaccine. Seven months 28 days post vaccination with the 2nd dose of mRNA-1273 vaccine she experienced non-serious, unexpected, AESI event of Covid 19. Drug ineffective (lack of Drug effect) was also reported for this case. Other non-serious, unexpected events reported were insomnia , polymers allergy, allergy to metals and allergy to chemicals  and non-serious, expected events of arthralgia 1 and 2   (shoulder pain) and hypersensitivity. The shoulder pain of the patient was initially experienced 3 months post vaccination with the 2nd dose of the mRNA-1273 which was relieved however recurred 5 months after. This patient visited the Dermatologist and was prescribed with Cortizone 10 which initially did not help but later when steroid cream was prescribed by the physician there was some relief. The details regarding the Covid-19 was not included in the report. The outcome of the event arthralgia (shoulder pain) was reported as resolved while the other events outcome was resolving. The benefit -risk relationship of mRNA -1273 (Moderna Covid-19 Vaccine) is not affected by this report. This case was linked to MOD-2022-533463 (Patient Link). Sender's Comments: This spontaneous case concerns a 60 year old female patient with no relevant medical history reported, who experienced Serious (Medically significant), unexpected event of Rash which occurred 5 months and 16 days post vaccination with the 2nd dose of mRNA-1273 vaccine. Seven months 28 days post vaccination with the 2nd dose of mRNA-1273 vaccine she experienced non-serious, unexpected, AESI event of Covid-19. Drug ineffective (lack of Drug effect) was also reported for this case. Other non-serious, unexpected events reported were insomnia, polymers allergy, allergy to metals and allergy to chemicals and non-serious, expected events of arthralgia 1 and 2 (shoulder pain) and hypersensitivity. The shoulder pain of the patient was initially experienced 3 months post vaccination with the 2nd dose of the mRNA-1273 which was relieved however recurred 5 months after. This patient visited the Dermatologist and was prescribed with Cortizone 10 which initially did not help but later when steroid cream was prescribed by the physician there was some relief. The details regarding the Covid-19 was not included in the report. The outcome of the event arthralgia (shoulder pain) was reported as resolved while the other events outcome was resolving. The benefit -risk relationship of mRNA -1273 (Moderna Covid-19 Vaccine) is not affected by this report.