Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Cataract, Chills, Cluster headache, Fatigue
Clinical narrative: Blurred vision; still has not recovered all of her taste buds since receiving the vaccinations; Difficulty seeing/ she needed to start taking her eyeglasses off to read things on her tv, phone and computer; headache; quick growing cataracts/ right eye stage 2+ on the scale of cataract ratings; pain in her right arm; cluster headache; hungry; she had lump at the injection site; nausea; muscle pain; chills; she felt really tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CATARACT (quick growing cataracts/ right eye stage 2+ on the scale of cataract ratings), PAIN IN EXTREMITY (pain in her right arm), CLUSTER HEADACHE (cluster headache), HUNGER (hungry) and VACCINATION SITE MASS (she had lump at the injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fibromyalgia, Neuropathy, Chronic fatigue, Opioid type dependence and Opioid type dependence. Concurrent medical conditions included Arthritis.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced FATIGUE (she felt really tired). On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in her right arm), CLUSTER HEADACHE (cluster headache), HUNGER (hungry), VACCINATION SITE MASS (she had lump at the injection site), NAUSEA (nausea), MYALGIA (muscle pain) and CHILLS (chills). On 01-Jul-2021, the patient experienced CATARACT (quick growing cataracts/ right eye stage 2+ on the scale of cataract ratings). On an unknown date, the patient experienced VISION BLURRED (Blurred vision), AGEUSIA (still has not recovered all of her taste buds since receiving the vaccinations), VISUAL IMPAIRMENT (Difficulty seeing/ she needed to start taking her eyeglasses off to read things on her tv, phone and computer) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, CATARACT (quick growing cataracts/ right eye stage 2+ on the scale of cataract ratings), VISION BLURRED (Blurred vision), AGEUSIA (still has not recovered all of her taste buds since receiving the vaccinations), VISUAL IMPAIRMENT (Difficulty seeing/ she needed to start taking her eyeglasses off to read things on her tv, phone and computer) and HEADACHE (headache) had not resolved and PAIN IN EXTREMITY (pain in her right arm), CLUSTER HEADACHE (cluster headache), HUNGER (hungry), VACCINATION SITE MASS (she had lump at the injection site), NAUSEA (nausea), MYALGIA (muscle pain), CHILLS (chills) and FATIGUE (she felt really tired) was resolving.            Concomitant product use was not reported.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Event of cataracts was automatically upgraded as a serious event as per IME list. However, based on the information available and as per medical judgment it is classified as Non-serious.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up received as no new information On 29-Jun-2021: Follow up received as no new information On 06-Jul-2021: Follow up received as added additional events (cataract, vision blurred, ageusia, withdrawal syndrome, unexpected therapeutic benefit, visual impairment, headache). The case is upgraded to serious as the event "cataract" is medically significant. Outcome of events not resolved (ongoing).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Event of cataracts was automatically upgraded as a serious event as per list. However, based on the information available and as per medical judgment it is classified as Non-serious.