Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Body temperature fluctuation, Dyspnoea, Eye colour change, Face oedema
Clinical narrative: the rash is mostly on her right forearm; her eyes and the line of the eyelash are black and little pink; really bothering me : body aches, and the allergy reactions; really bothering me : body aches, and the allergy reactions; shaking; felt flu like symptoms; slept 36 hours straight; had a lot of nightmares; it was really strange , like i was not fully awake, like an alternate state; She knew she had to wake up and do some things like call a person but she could not actually; 3 hours after the shot, patient started to feel, extreme fatigue; Needed to stop walking because she had difficulty breathing; body pain; swollen face since she got the vaccine; face swollen and also the glands under her chin , her hands are swollen up; her throat is swollen and has a whizzing when breathing; Rash on her body; problems regulating her body temperature, she was extremely hot or extremely cold; lost her ability to walk, with no balance; had difficult to get her legs into her car, could not lift the legs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HALLUCINATION (She knew she had to wake up and do some things like call a person but she could not actually) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Allergic reaction (allergic reaction around 10 years ago with a flu shot). Concomitant products included VITAMIN D3, ZINC and MONTELUKAST for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 22-Feb-2021, the patient experienced FATIGUE (3 hours after the shot, patient started to feel, extreme fatigue), DYSPNOEA (Needed to stop walking because she had difficulty breathing), MYALGIA (body pain), FACE OEDEMA (swollen face since she got the vaccine), SWELLING (face swollen and also the glands under her chin , her hands are swollen up), LYMPHADENOPATHY (her throat is swollen and has a whizzing when breathing), RASH (Rash on her body), BODY TEMPERATURE FLUCTUATION (problems regulating her body temperature, she was extremely hot or extremely cold), BALANCE DISORDER (lost her ability to walk, with no balance) and GAIT DISTURBANCE (had difficult to get her legs into her car, could not lift the legs). On 26-Feb-2021, the patient experienced HALLUCINATION (She knew she had to wake up and do some things like call a person but she could not actually) (seriousness criterion medically significant), TREMOR (shaking), INFLUENZA LIKE ILLNESS (felt flu like symptoms), HYPERSOMNIA (slept 36 hours straight), NIGHTMARE (had a lot of nightmares) and FEELING ABNORMAL (it was really strange , like i was not fully awake, like an alternate state). On 12-Mar-2021, the patient experienced RASH (the rash is mostly on her right forearm), EYE COLOUR CHANGE (her eyes and the line of the eyelash are black and little pink), PAIN (really bothering me : body aches, and the allergy reactions) and TYPE IV HYPERSENSITIVITY REACTION (really bothering me : body aches, and the allergy reactions). On 24-Feb-2021, BODY TEMPERATURE FLUCTUATION (problems regulating her body temperature, she was extremely hot or extremely cold) had resolved. At the time of the report, HALLUCINATION (She knew she had to wake up and do some things like call a person but she could not actually), FATIGUE (3 hours after the shot, patient started to feel, extreme fatigue), DYSPNOEA (Needed to stop walking because she had difficulty breathing), MYALGIA (body pain), FACE OEDEMA (swollen face since she got the vaccine), SWELLING (face swollen and also the glands under her chin , her hands are swollen up), LYMPHADENOPATHY (her throat is swollen and has a whizzing when breathing), RASH (Rash on her body), RASH (the rash is mostly on her right forearm), EYE COLOUR CHANGE (her eyes and the line of the eyelash are black and little pink), TREMOR (shaking), INFLUENZA LIKE ILLNESS (felt flu like symptoms), HYPERSOMNIA (slept 36 hours straight), NIGHTMARE (had a lot of nightmares), FEELING ABNORMAL (it was really strange , like i was not fully awake, like an alternate state), PAIN (really bothering me : body aches, and the allergy reactions), TYPE IV HYPERSENSITIVITY REACTION (really bothering me : body aches, and the allergy reactions), BALANCE DISORDER (lost her ability to walk, with no balance) and GAIT DISTURBANCE (had difficult to get her legs into her car, could not lift the legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications also included supplements (not specified).  Montelukast, ibuprofen 800mg daily since the 1st dose was administered.  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.; 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.