Age: 68.0
Sex: F
Vaccine: FLUX, UNK
Symptoms: Post inflammatory pigmentation change, Rash
Clinical narrative: rash; sore throat; patient had darkening under the eye; red and swelling under eye; red and swelling under eye; post inflammatory hyperpigmentation; This spontaneous case was reported by a patient and describes the occurrence of POST INFLAMMATORY PIGMENTATION CHANGE (post inflammatory hyperpigmentation) in a 68-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030335) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:asthma, 2017 hypogammaglobulinemia, brain tumor 2016 menengeoma.  Concurrent medical conditions included Asthma, Hypogammaglobulinemia since 2017, Brain tumor, Meningioma since 2016 and Dermal filler reaction (Had facial injury) since 11-Aug-2023.   On 21-Sep-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. In September 2023, the patient experienced POST INFLAMMATORY PIGMENTATION CHANGE (post inflammatory hyperpigmentation) (seriousness criterion medically significant). On 22-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced OCULAR HYPERAEMIA (red and swelling under eye) and EYE SWELLING (red and swelling under eye). On 23-Sep-2023, the patient experienced EYELASH HYPERPIGMENTATION (patient had darkening under the eye). On 27-Oct-2023, the patient experienced OROPHARYNGEAL PAIN (sore throat). On an unknown date, the patient experienced RASH (rash). The patient was treated with SIBUTRAMINE HYDROCHLORIDE MONOHYDRATE (GOLDLINE) at a dose of For 2 weeks; DOXYCYCLINE HYCLATE (HYCLATE) at a dose of For 2 weeks; CEFALEXIN (CEPHALEXINE) at an unspecified dose and frequency and HYDROQUINONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, POST INFLAMMATORY PIGMENTATION CHANGE (post inflammatory hyperpigmentation), OROPHARYNGEAL PAIN (sore throat), OCULAR HYPERAEMIA (red and swelling under eye) and EYE SWELLING (red and swelling under eye) had not resolved and EYELASH HYPERPIGMENTATION (patient had darkening under the eye) and RASH (rash) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: Fine.         It was reported that patient receives other vaccines in the four weeks prior to covid-19 vaccine. Patient never had covid.  Concomitant product use was not provided by the reporter.  It was reported patient receives latest covid-19 vaccine and flu shot on 21-Sep-2023. On 22-Sep-2023 she had red and swelling under eye. Physician said they had seen this kind of reaction. She received a rash after taking prescribed antibiotic, goldline, hyclate for 2 weeks also got cephalexin as well. The next morning patient had darkening under the eye. Three days later was diagnosed with post inflammatory hyperpigmentation and started patient on long course of hydroquinone for 3 or 4 months. It might be permanent.   Company Comment This spontaneous case concerns a 68 years-old female patient with medical history of Co-suspect product included non-company product INFLUENZA VACCINE, asthma, 2017 hypogammaglobulinemia, meningioma tumor 2016, had a facial injury, dermal fillers in both eye troughs and nasolabial and chin area in august 2021 who experienced the unexpected seriousness criterion medically significant event of post inflammatory pigmentation change; the unexpected event of oropharyngeal pain, ocular hyperaemia, eye swelling, eyelash hyperpigmentation and other expected event the same month after 6th. dose of mRNA-1273.815 vaccine. The medical history of facial injury, dermal fillers in both eye troughs and nasolabial and chin area in august 2021 is a contributor for the events. The benefit-risk relationship of mRNA-1273.815 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-747888 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747888:Bivalent dose