Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immunisation reaction, Muscular weakness, Pain in extremity, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: This situation happened again last night, 28Apr2022, she had severe pain. This is still ongoing, she is in pain right now; She can´t bring her coffee cup to her lips.; Then the night of the 27Apr2022 she woke up having the same pain for 3 hours and then it went away); Very severe arm pain. Her upper arm region was in pain, and it started radiating down the arm and up the neck.; Severe arm pain that started on the deltoid area, and then radiated down the arm and up the neck; The arm was weak/ Weakness on her arm/ Weak enough she can´t raise her; She couldn´t lift any weight over her head (which is a normal thing for her, she can usually lift 16 lbs over her head.) It was very hard for her to lift her arm over her head. Started lifting 4 lbs and then 6 lbs; Delayed reaction to the vaccine; Localized pain on the injection site/ After fourth dose, the pain was different; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Delayed reaction to the vaccine), PAIN IN EXTREMITY (Severe arm pain that started on the deltoid area, and then radiated down the arm and up the neck), MUSCULAR WEAKNESS (The arm was weak/ Weakness on her arm/ Weak enough she can´t raise her), VACCINATION SITE MOVEMENT IMPAIRMENT (She couldn´t lift any weight over her head (which is a normal thing for her, she can usually lift 16 lbs over her head.) It was very hard for her to lift her arm over her head. Started lifting 4 lbs and then 6 lbs) and PAIN IN EXTREMITY (Very severe arm pain. Her upper arm region was in pain, and it started radiating down the arm and up the neck.) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A and R89350 & 1822809) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Allergies (medications, food, and other products). Patient has never had COVID. No vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Cataract. Concomitant products included CANNABIDIOL (CBD OIL), SIMVASTATIN and FAMOTIDINE for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. In April 2022, the patient experienced IMMUNISATION REACTION (Delayed reaction to the vaccine) and VACCINATION SITE PAIN (Localized pain on the injection site/ After fourth dose, the pain was different). On 16-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Severe arm pain that started on the deltoid area, and then radiated down the arm and up the neck), MUSCULAR WEAKNESS (The arm was weak/ Weakness on her arm/ Weak enough she can´t raise her) and VACCINATION SITE MOVEMENT IMPAIRMENT (She couldn´t lift any weight over her head (which is a normal thing for her, she can usually lift 16 lbs over her head.) It was very hard for her to lift her arm over her head. Started lifting 4 lbs and then 6 lbs). On 26-Apr-2022, the patient experienced PAIN IN EXTREMITY (Very severe arm pain. Her upper arm region was in pain, and it started radiating down the arm and up the neck.). On 27-Apr-2022, the patient experienced PAIN IN EXTREMITY (Then the night of the 27Apr2022 she woke up having the same pain for 3 hours and then it went away)). On 28-Apr-2022, the patient experienced PAIN IN EXTREMITY (This situation happened again last night, 28Apr2022, she had severe pain. This is still ongoing, she is in pain right now) and VACCINATION SITE MOVEMENT IMPAIRMENT (She can´t bring her coffee cup to her lips.). In April 2022, PAIN IN EXTREMITY (Severe arm pain that started on the deltoid area, and then radiated down the arm and up the neck), VACCINATION SITE MOVEMENT IMPAIRMENT (She couldn´t lift any weight over her head (which is a normal thing for her, she can usually lift 16 lbs over her head.) It was very hard for her to lift her arm over her head. Started lifting 4 lbs and then 6 lbs), PAIN IN EXTREMITY (Very severe arm pain. Her upper arm region was in pain, and it started radiating down the arm and up the neck.) and PAIN IN EXTREMITY (Then the night of the 27Apr2022 she woke up having the same pain for 3 hours and then it went away)) had resolved. At the time of the report, IMMUNISATION REACTION (Delayed reaction to the vaccine) and VACCINATION SITE PAIN (Localized pain on the injection site/ After fourth dose, the pain was different) outcome was unknown and MUSCULAR WEAKNESS (The arm was weak/ Weakness on her arm/ Weak enough she can´t raise her), PAIN IN EXTREMITY (This situation happened again last night, 28Apr2022, she had severe pain. This is still ongoing, she is in pain right now) and VACCINATION SITE MOVEMENT IMPAIRMENT (She can´t bring her coffee cup to her lips.) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter stated that the patient had localized pain at the injection site after receiving the four doses. However, after the fourth dose the pain was different. Patient has not experienced a similar event (severe arm pain) in the past.  Patient sought medical care. Doctor suggested physical therapy and oral steroids. However, the patient is having cataract surgery so she won´t take the steroids.   This case was linked to MOD-2022-554220, MOD-2022-554221, MOD-2022-554223 (Patient Link).