Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Cataract, Condition aggravated, Hypersensitivity, Oxygen saturation decreased, Sleep apnoea syndrome
Clinical narrative: Sleep apnea; SLEEP APNEA WORSENED; Oxygen saturation low at night during sleep; Injection site stinging; Weight gain/she gained around 20 to 25lbs since the start of the pandemic.; Allergy; Cataract on both eyes and she was her condition was slowly declining due to her age.; Injection site stinging; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP APNOEA SYNDROME (Sleep apnea) and CATARACT (Cataract on both eyes and she was her condition was slowly declining due to her age.) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis and Plaque psoriasis.    The patient's past medical history included Bilateral cataracts in 2016. Concurrent medical conditions included Social alcohol drinker (NON ALCOHOL USER,ALCOHOL USER ONE GLASS OF MARGARITA SOCIALLY.), Sleep apnea, Blood pressure high, Pre-diabetes, Pollen allergy (MANIFESTATED BY RUNNY NOSE.), Allergy to plants (MANIFESTATED BY RUNNY NOSE.), Dust allergy (MANIFESTATED BY RUNNY NOSE.), Drug allergy (ASPIRIN ALLERGY, MANIFESTATED BY UPSET STOMACH/BLEEDING.), Drug allergy (IBUPROFEN ALLERGY, MANIFESTATED BY UPSET STOMACH/BLEEDING.), Drug allergy (ASPARTAME ALLERGY, MANIFESTATED BY UPSET STOMACH/BLEEDING.), Ulcerative colitis and Plaque psoriasis. Concomitant products included LOSARTAN and HYDROCHLOROTHIAZIDE for Blood pressure high, METFORMIN for Pre-diabetic, VITAMIN D3 and GABAPENTIN for an unknown indication.   In 2012, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram once a week. In 2012, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram once a week. On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2012, the patient experienced the first episode of VACCINATION SITE PAIN (Injection site stinging). In 2016, the patient experienced CATARACT (Cataract on both eyes and she was her condition was slowly declining due to her age.) (seriousness criterion medically significant). In 2017, the patient experienced HYPERSENSITIVITY (Allergy). In 2020, the patient experienced WEIGHT INCREASED (Weight gain/she gained around 20 to 25lbs since the start of the pandemic.). In 2021, the patient experienced the second episode of VACCINATION SITE PAIN (Injection site stinging). On an unknown date, the patient experienced SLEEP APNOEA SYNDROME (Sleep apnea) (seriousness criterion medically significant), CONDITION AGGRAVATED (SLEEP APNEA WORSENED) and OXYGEN SATURATION DECREASED (Oxygen saturation low at night during sleep). The patient was treated with FLUTICASONE at an unspecified dose and frequency and Surgery (cataract surgery on her left eye on ??-May-2021 and also had second eye cataract surgery.) for Cataract. At the time of the report, SLEEP APNOEA SYNDROME (Sleep apnea), CONDITION AGGRAVATED (SLEEP APNEA WORSENED), OXYGEN SATURATION DECREASED (Oxygen saturation low at night during sleep) and the last episode of VACCINATION SITE PAIN (Injection site stinging) outcome was unknown, CATARACT (Cataract on both eyes and she was her condition was slowly declining due to her age.) and HYPERSENSITIVITY (Allergy) was resolving and WEIGHT INCREASED (Weight gain/she gained around 20 to 25lbs since the start of the pandemic.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Weight increased: gained around 20 to 25lbs..         She had an intrinsic eye test, however, she was unable to remember the names and results of those test  Patient noted that her oxygen level recently dropped while sleeping and her HCP decided to upgrade her C-pap machine for her sleep apnea and however, on her recent dose 2 of Humira, she never felt that sting(vaccination site stinging).  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.  The reporters causality for the events of SLEEP APNEA, CATARACT, OXYGEN LEVEL LOW AT NIGHT DURING SLEEP, ALLERGIES, STINGING AT INJECTION SITE and WEIGHT GAIN with HUMIRA 40MG/0.4ML(ADALIMUMAB) was no reasonable possibility and there is a reasonable possibility that the event of STINGING AT INJECTION SITE is related to HUMIRA 40MG/0.4ML(ADALIMUMAB).  Company Comment: This is a spontaneous case concerning a 61-year-old female patient with medical history of sleep apnea and cataract of both eyes, who experienced the unexpected, serious (medically significant) events of Sleep apnoea syndrome and Cataract, after receiving the second dose of mRNA-1273 vaccine. The patient had cataract surgery of her left eye approximately 3 months after receiving the second dose of mRNA-1273 and had a second cataract surgery on unknown date. On unknown date, the patient noted that her oxygen level recently dropped while sleeping and her HCP decided to upgrade her C-pap machine for her sleep apnea. The event Cataract was resolving while the event Sleep apnoea syndrome had worsened at the time of the report. Medical history of sleep apnea remains a risk factor for the event of Sleep apnoea syndrome and medical history of cataract of both eyes remains a risk factor for the event of Cataract. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 61-year-old female patient with medical history of sleep apnea and cataract of both eyes, who experienced the unexpected, serious (medically significant) events of Sleep apnoea syndrome and Cataract, after receiving the second dose of mRNA-1273 vaccine. The patient had cataract surgery of her left eye approximately 3 months after receiving the second dose of mRNA-1273 and had a second cataract surgery on unknown date. On unknown date, the patient noted that her oxygen level recently dropped while sleeping and her HCP decided to upgrade her C-pap machine for her sleep apnea. The event Cataract was resolving while the event Sleep apnoea syndrome had worsened at the time of the report. Medical history of sleep apnea remains a risk factor for the event of Sleep apnoea syndrome and medical history of cataract of both eyes remains a risk factor for the event of Cataract. The benefit-risk relationship of mRNA-1273 is not affected by this report.