Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain of skin, Skin burning sensation, Suspected COVID-19, Vaccination site pain
Clinical narrative: COVID-like symptoms; neurological events/neurological side effects/progressed from her legs into her head; vision affected; blurry eyes; affected joint of her shoulder; hair loss; scalp is burning; burning in her leg; soreness of the scalp; pain all over/pain; Patient got worse and noticed a slow progression affecting her body it's gone completely all over my body, her arms, her legs. With the booster it was awful; arm on which she received the booster is sore and hurting; This spontaneous case was reported by a patient and describes the occurrence of SUSPECTED COVID-19 (COVID-like symptoms), NEUROLOGICAL SYMPTOM (neurological events/neurological side effects/progressed from her legs into her head), VISUAL IMPAIRMENT (vision affected), VISION BLURRED (blurry eyes) and ARTHROPATHY (affected joint of her shoulder) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033h21a and 012m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (adverse reactions to medications), Pollen allergy and Seasonal allergy.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (COVID-like symptoms), NEUROLOGICAL SYMPTOM (neurological events/neurological side effects/progressed from her legs into her head), VISUAL IMPAIRMENT (vision affected), VISION BLURRED (blurry eyes), ARTHROPATHY (affected joint of her shoulder), ALOPECIA (hair loss), SKIN BURNING SENSATION (scalp is burning), BURNING SENSATION (burning in her leg), PAIN OF SKIN (soreness of the scalp), PAIN (pain all over/pain), CONDITION AGGRAVATED (Patient got worse and noticed a slow progression affecting her body it's gone completely all over my body, her arms, her legs. With the booster it was awful) and VACCINATION SITE PAIN (arm on which she received the booster is sore and hurting). At the time of the report, SUSPECTED COVID-19 (COVID-like symptoms), NEUROLOGICAL SYMPTOM (neurological events/neurological side effects/progressed from her legs into her head), VISUAL IMPAIRMENT (vision affected), VISION BLURRED (blurry eyes), ARTHROPATHY (affected joint of her shoulder), ALOPECIA (hair loss), SKIN BURNING SENSATION (scalp is burning), BURNING SENSATION (burning in her leg), PAIN OF SKIN (soreness of the scalp), PAIN (pain all over/pain), CONDITION AGGRAVATED (Patient got worse and noticed a slow progression affecting her body it's gone completely all over my body, her arms, her legs. With the booster it was awful) and VACCINATION SITE PAIN (arm on which she received the booster is sore and hurting) had not resolved.            No concomitant medications were reported.  Patient went to the ER on Jan, Feb and March 2022. The HCP initially told patient to drink plenty of water. The patient was not getting better, the symptoms have intensified.  No treatment medications were reported.  Company comment: This is a spontaneous case concerning a 87-year-old, female patient with no relevant medical history. The patient has vaccination history of receiving first and second dose of mRNA-1273 vaccine with unknown dosage interval. The patient experienced the unexpected non-serious AESI event of suspected Covid-19 (Covid-like symptoms), the unexpected non-serious events of pain, soreness of the scalp, hair loss, skin burning sensation (scalp is burning), burning sensation (burning in her leg), neurological symptom (neurological events/neurological side effects/progressed from her legs into her head), vision blurred (blurry eyes), visual impairment (vision affected), arthropathy (affected joint of her shoulder), condition aggravated (patient got worse and noticed a slow progression affecting her body it's gone completely all over my body, her arms, her legs), and the expected non-serious event of vaccination site pain. The event neurological symptom was reported to occurred within a couple of days receiving the third dose (first booster) of mRNA-1273 vaccine. The rest of the events occurrence unknown with respect to the third dose (first booster) of mRNA-1273 vaccine. Allegedly the events were described as, on unknown date the patient experienced pain in the vaccinated arm and affected the patient's shoulder joint. On unknown date, the patient experienced neurological events within a couple of days of receiving the third dose (first booster) of mRNA-1273 vaccine. On unknown date, it was reported that the patient got worse and noticed a slow progression affecting all over her body, her arms, legs, head with blurry eyes which affect the patient's vision. It was reported that that the patient sought emergency room consult on the same month, the month after and approximately 2 months after the third dose (first booster) of mRNA-1273 vaccine administration. It was reported that the initial health care practitioner advised her to drink plenty of water. No further clinical information was available for medical review. The patient's age remain confounder for the events vision blurred (blurry eyes), and visual impairment (vision affected). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-648216 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 87-year-old, female patient with no relevant medical history. The patient has vaccination history of receiving first and second dose of mRNA-1273 vaccine with unknown dosage interval. The patient experienced the unexpected non-serious AESI event of suspected Covid-19 (Covid-like symptoms), the unexpected non-serious events of pain, soreness of the scalp, hair loss, skin burning sensation (scalp is burning), burning sensation (burning in her leg), neurological symptom (neurological events/neurological side effects/progressed from her legs into her head), vision blurred (blurry eyes), visual impairment (vision affected), arthropathy (affected joint of her shoulder), condition aggravated (patient got worse and noticed a slow progression affecting her body it's gone completely all over my body, her arms, her legs), and the expected non-serious event of vaccination site pain. The event neurological symptom was reported to occurred within a couple of days receiving the third dose (first booster) of mRNA-1273 vaccine. The rest of the events occurrence unknown with respect to the third dose (first booster) of mRNA-1273 vaccine. Allegedly the events were described as, on unknown date the patient experienced pain in the vaccinated arm and affected the patient's shoulder joint. On unknown date, the patient experienced neurological events within a couple of days of receiving the third dose (first booster) of mRNA-1273 vaccine. On unknown date, it was reported that the patient got worse and noticed a slow progression affecting all over her body, her arms, legs, head with blurry eyes which affect the patient's vision. It was reported that that the patient sought emergency room consult on the same month, the month after and approximately 2 months after the third dose (first booster) of mRNA-1273 vaccine administration. It was reported that the initial health care practitioner advised her to drink plenty of water. No further clinical information was available for medical review. The patient's age remain confounder for the events vision blurred (blurry eyes), and visual impairment (vision affected). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.