Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Incorrect dose administered, Limb discomfort, Pain in extremity, Product administration error
Clinical narrative: After first dose for two days I couldn't move my arm; Swollen with circular black and blue bruises in the injection site; Trouble raising her arm; The huge sore became hot to touch; Blue bruises in the injection site; I think this happened because the person that administered the vaccine did it wrong; I don't think I received a full dose vaccine from first dose.; Arm bleed; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Arm bleed) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Kidney stone (More than once) and Shingles (More than once). Concurrent medical conditions included Multiple allergies (had a lot of allergies) and Chronic pain. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 29-Apr-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced HAEMORRHAGE (Arm bleed) (seriousness criterion medically significant), PRODUCT ADMINISTRATION ERROR (I think this happened because the person that administered the vaccine did it wrong), INCORRECT DOSE ADMINISTERED (I don't think I received a full dose vaccine from first dose.) and PAIN IN EXTREMITY (sore arm). On 01-May-2021, the patient experienced LIMB DISCOMFORT (Trouble raising her arm), VACCINATION SITE WARMTH (The huge sore became hot to touch), VACCINATION SITE BRUISING (Blue bruises in the injection site) and VACCINATION SITE SWELLING (Swollen with circular black and blue bruises in the injection site). On an unknown date, the patient experienced LIMB DISCOMFORT (After first dose for two days I couldn't move my arm). On 29-Apr-2021, PRODUCT ADMINISTRATION ERROR (I think this happened because the person that administered the vaccine did it wrong) and INCORRECT DOSE ADMINISTERED (I don't think I received a full dose vaccine from first dose.) had resolved. At the time of the report, HAEMORRHAGE (Arm bleed), VACCINATION SITE WARMTH (The huge sore became hot to touch), PAIN IN EXTREMITY (sore arm) and VACCINATION SITE SWELLING (Swollen with circular black and blue bruises in the injection site) outcome was unknown and LIMB DISCOMFORT (Trouble raising her arm), VACCINATION SITE BRUISING (Blue bruises in the injection site) and LIMB DISCOMFORT (After first dose for two days I couldn't move my arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient wanted to report the side effects they experienced post receiving their first shot of Moderna vaccine. After a few hours their arm developed a huge sore 1 and ½ inches in size and the patient had trouble raising their arm. The patient day before reporting woke up and had a problem lifting their arm. The patient reported that the huge sore became hot to touch, was swollen with circular black and had blue bruises in the injection site. The patient mentioned that they had a lot of allergies. On 02-Jun-2021, the patient reported adverse reaction patient had from dose one and reported huge adverse reaction to dose two.  The patient post first dose for two days was not able to move their arm and had a bruise that lasted for two weeks. The patient stated that now they think this happened because the person that administered the vaccine did it wrong and vaccine went into wrong place. Post receiving their first dose the patient said one of their arms was bleeding.  The patient went back to the vaccination site and had been complaining so much because the registered nurse let the patient know that the Nurse didn't wore gloves nor shield and was anti-vaccinated.  The patient also stated that they don't think that they received a full dose vaccine from first dose. The patient also reported that they were a chronic pain patient and had kidney stone and shingles more than once and understood pain.  The patient wanted antibody test done because the patient think they didn't receive a full active first dose and wanted to have it after first dose but couldn't get it and still wanted to do this post second dose. Concomitant medication reported also included over the counter medicine but didn't specified the name. No treatment medication was reported. The patient informed that they slept and drunk a lot. No specific treatment was taken.   Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. Vaccination site swelling are consistent with the known safety profile of the vaccine.  This case was linked to MOD-2021-201885 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Email response. No significant information found. On 02-Jun-2021: Added Reporter Details. Added current and historical conditions under relevant medical history. Updated action taken. Updated concomitant medication in I-narrative supplement field.  Added new events and updated the event description and outcome of the events.; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. Vaccination site swelling are consistent with the known safety profile of the vaccine.