Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Limb mass, Mobility decreased, Suspected product quality issue, Vaccination site inflammation
Clinical narrative: At the moment, she cant lift her arm up; Surgery Doctor said that "It was a 3, 5, 6 mass and never saw something like that before"; Her eyes are getting bad now; The second shot messed up my arm/"Something was wrong with the shot",/My Doctor said that i can't get any more shots"; An hour later of receiving the second shot, my arm swallowed up like the size of a grapefruit/Arm inflammation lasted for a month; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (At the moment, she cant lift her arm up) and LIMB MASS (Surgery Doctor said that "It was a 3, 5, 6 mass and never saw something like that before") in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arm operation in November 2021. Previously administered products included for COVID-19 vaccination: Moderna COVID-19 vaccine on 12-Mar-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 vaccine. Concurrent medical conditions included Drug allergy (Patient was allergic to Aminophylline).   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced VACCINATION SITE INFLAMMATION (An hour later of receiving the second shot, my arm swallowed up like the size of a grapefruit/Arm inflammation lasted for a month). On an unknown date, the patient experienced MOBILITY DECREASED (At the moment, she cant lift her arm up) (seriousness criterion disability), LIMB MASS (Surgery Doctor said that "It was a 3, 5, 6 mass and never saw something like that before") (seriousness criterion medically significant), EYE DISORDER (Her eyes are getting bad now) and SUSPECTED PRODUCT QUALITY ISSUE (The second shot messed up my arm/"Something was wrong with the shot",/My Doctor said that i can't get any more shots"). At the time of the report, MOBILITY DECREASED (At the moment, she cant lift her arm up), LIMB MASS (Surgery Doctor said that "It was a 3, 5, 6 mass and never saw something like that before"), EYE DISORDER (Her eyes are getting bad now), VACCINATION SITE INFLAMMATION (An hour later of receiving the second shot, my arm swallowed up like the size of a grapefruit/Arm inflammation lasted for a month) and SUSPECTED PRODUCT QUALITY ISSUE (The second shot messed up my arm/"Something was wrong with the shot",/My Doctor said that i can't get any more shots") outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient never tested positive for COVID-19 and did not receive any other vaccine within one month prior to Moderna vaccine. At the time of the vaccination, she did not have any acute or chronic illnesses and she was not taking any concomitant medication.  Company Comment: This spontaneous case concerns a 53-year-old, female patient, with no relevant medical history, who experienced an unexpected, disabling, and ongoing serious event of Mobility decreased and an unexpected, medically significant serious event of Limb mass that occurred on an unspecified date after receiving dose 2 of mRNA-1273 vaccine. An hour after receiving her second dose of mRNA-1273, the patient reportedly experienced her arm swelled up to a size of a grapefruit and the inflammation lasted for a month. The patient added that she underwent an unspecified arm surgery due to a "3, 5, 6 mass" 7 months post-vaccination with dose 2 of mRNA-1273. The patient also reported that her eyes are getting bad now. The patient suspected product quality issue (The second shot messed up my arm/"Something was wrong with the shot",/My Doctor said that i can't get any more shots") with her second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 16-Mar-2022: Live non-significant follow-up received. No new information was added.; Sender's Comments: This spontaneous case concerns a 53-year-old, female patient, with no relevant medical history, who experienced an unexpected, disabling, and ongoing serious event of Mobility decreased and an unexpected, medically significant serious event of Limb mass that occurred on an unspecified date after receiving dose 2 of mRNA-1273 vaccine. An hour after receiving her second dose of mRNA-1273, the patient reportedly experienced her arm swelled up to a size of a grapefruit and the inflammation lasted for a month. The patient added that she underwent an unspecified arm surgery due to a "3, 5, 6 mass" 7 months post-vaccination with dose 2 of mRNA-1273. The patient also reported that her eyes are getting bad now. The patient suspected product quality issue (The second shot messed up my arm/"Something was wrong with the shot",/My Doctor said that i can't get any more shots") with her second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.