Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Consumer mentioned he/she has problem of facial neuralgia (left side) and it has worsened after getting vaccination dose, it is twitching more/progressively worsened/obviously so much pain was there in left arm; Consumer called doctor after another week as shoulder hurt and couldn't' lift arm to certain extent/Limited movement was there along with pain/Consumer stated that he/she cannot hold hair dryer or getting dressed also hurts; Regular orthopedic doctor said it can be from shoulder injury related to vaccine shot; it is twitching more; He/she doesn't get sleep at night and try to lay down during day but it is hard; Consumer mentioned that shoulder upper arm hurts; Arm hurt; Arm hurt,it was hurting bad,Cannot hold hair dryer or getting dressed also hurts; Swollen arm; Burning sensation; Couple of days later on 24 Mar2021 was given Prednisone treatment. There was weird feeling/feeling strange; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Jun-2021 and was forwarded to Moderna on 08-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Consumer mentioned he/she has problem of facial neuralgia (left side) and it has worsened after getting vaccination dose, it is twitching more/progressively worsened/obviously so much pain was there in left arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Facial neuralgia.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), BURNING SENSATION (Burning sensation), FEELING ABNORMAL (Couple of days later on 24 Mar2021 was given Prednisone treatment. There was weird feeling/feeling strange), PAIN IN EXTREMITY (Arm hurt) and MYALGIA (Arm hurt,it was hurting bad,Cannot hold hair dryer or getting dressed also hurts). On an unknown date, the patient experienced CONDITION AGGRAVATED (Consumer mentioned he/she has problem of facial neuralgia (left side) and it has worsened after getting vaccination dose, it is twitching more/progressively worsened/obviously so much pain was there in left arm) (seriousness criterion medically significant), MOBILITY DECREASED (Consumer called doctor after another week as shoulder hurt and couldn't' lift arm to certain extent/Limited movement was there along with pain/Consumer stated that he/she cannot hold hair dryer or getting dressed also hurts), LIMB INJURY (Regular orthopedic doctor said it can be from shoulder injury related to vaccine shot), MUSCLE TWITCHING (it is twitching more), INSOMNIA (He/she doesn't get sleep at night and try to lay down during day but it is hard) and ARTHRALGIA (Consumer mentioned that shoulder upper arm hurts). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency; MELOXICAM at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, CONDITION AGGRAVATED (Consumer mentioned he/she has problem of facial neuralgia (left side) and it has worsened after getting vaccination dose, it is twitching more/progressively worsened/obviously so much pain was there in left arm), PERIPHERAL SWELLING (Swollen arm), BURNING SENSATION (Burning sensation), FEELING ABNORMAL (Couple of days later on 24 Mar2021 was given Prednisone treatment. There was weird feeling/feeling strange), MOBILITY DECREASED (Consumer called doctor after another week as shoulder hurt and couldn't' lift arm to certain extent/Limited movement was there along with pain/Consumer stated that he/she cannot hold hair dryer or getting dressed also hurts), LIMB INJURY (Regular orthopedic doctor said it can be from shoulder injury related to vaccine shot), MUSCLE TWITCHING (it is twitching more), INSOMNIA (He/she doesn't get sleep at night and try to lay down during day but it is hard), PAIN IN EXTREMITY (Arm hurt), MYALGIA (Arm hurt,it was hurting bad,Cannot hold hair dryer or getting dressed also hurts) and ARTHRALGIA (Consumer mentioned that shoulder upper arm hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information not provided.  Treatment medication includes Steroid injection as well. 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. Additionally, patient's medical history can also have compounding effects that can also contribute to a possible causal relationship. Further information has been requested.; 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. Additionally, patient's medical history can also have compounding effects that can also contribute to a possible causal relationship. Further information has been requested.