Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Tested positive for COVID-19; Her arms were going numb; The reaction got worst; Lack of drug effect; She freaked out; Lymph node on her neck swelled up/Lymph node on her neck had like a big bowling ball/It swelled up under her armpit/Right side also swelled up but not as much; Lymph node swelled up more so on the left side, were she got the shot; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (She freaked out), CONDITION AGGRAVATED (The reaction got worst), DRUG INEFFECTIVE (Lack of drug effect), PAIN IN EXTREMITY (Sore arm) and SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to plants (Allergies to Cedar tree, very common in (privacy)). Concomitant products included CALCIUM and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 04-May-2021, the patient experienced ANXIETY (She freaked out), LYMPHADENOPATHY (Lymph node on her neck swelled up/Lymph node on her neck had like a big bowling ball/It swelled up under her armpit/Right side also swelled up but not as much) and VACCINATION SITE SWELLING (Lymph node swelled up more so on the left side, were she got the shot). In January 2022, the patient experienced CONDITION AGGRAVATED (The reaction got worst), DRUG INEFFECTIVE (Lack of drug effect), SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) and HYPOAESTHESIA (Her arms were going numb). On 05-May-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, ANXIETY (She freaked out), CONDITION AGGRAVATED (The reaction got worst), SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19), HYPOAESTHESIA (Her arms were going numb), LYMPHADENOPATHY (Lymph node on her neck swelled up/Lymph node on her neck had like a big bowling ball/It swelled up under her armpit/Right side also swelled up but not as much) and VACCINATION SITE SWELLING (Lymph node swelled up more so on the left side, were she got the shot) had not resolved and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Magnetic resonance imaging: results awaited An MRI was performed and she was waiting for the result. On an unknown date, Ultrasound scan: normal (normal) A sonogram of the lymph node on her neck was performed and the result was normal.         Patient not had history related to mentioned adverse events and not had both acute and chronic illnesses at the time of vaccination. Patient not had other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Both doses were administered on the patient left arm, which was the non-dominant arm. The adverse event caused patient to visit office for medical care. Treatment medications information included patient had steroids that helped a little bit and lymphatic massages: she could feel the swelling draining, after the massage it was half its size, but it went back and there was no permanent fix.  Company comment: This spontaneous case concerns a 53-year-old female patient with medical history of allergy to plants, who experienced non-serious Lack of drug effect and Tested positive for COVID-19 after approximately within 9 months after the second dose of mRNA-1273. The patient experienced additional non-serious events listed above. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-485348 (Patient Link).; Sender's Comments: This spontaneous case concerns a 53-year-old female patient with medical history of allergy to plants, who experienced non-serious Lack of drug effect and Tested positive for COVID-19 after approximately within 9 months after the second dose of mRNA-1273. The patient experienced additional non-serious events listed above. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.