Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Body temperature, Feeling abnormal, Inappropriate schedule of product administration, Lymph node rupture
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE RUPTURE (Thinks lymph node is ruptured) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048L21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Iron deficiency anemia (Iron deficiency anemia during menopause (its gone now)). Previously administered products included for Drug use for unknown indication: PFIZER vaccine (primary series and first booster dose). Past adverse reactions to the above products included No adverse event with PFIZER vaccine. Concurrent medical conditions included Fibroids. On 04-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2022, the patient experienced LYMPH NODE RUPTURE (Thinks lymph node is ruptured) (seriousness criterion medically significant), FEELING ABNORMAL (Felt like a truck hit her /was miserable throughout the night), LYMPHADENOPATHY (Swelling of the lymph node / lymph nodes were large grape-life / firm under the armpit/swollen/lymph node is bulging/swelling like a outward down), AXILLARY PAIN (Her entire armpit was like a bee stung / states it is painful), PYREXIA (Had a 102 F. temp.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had primary series and first booster dose as PFIZER and 2nd booster shot as Moderna). At the time of the report, LYMPH NODE RUPTURE (Thinks lymph node is ruptured), FEELING ABNORMAL (Felt like a truck hit her /was miserable throughout the night), LYMPHADENOPATHY (Swelling of the lymph node / lymph nodes were large grape-life, / firm under the armpit/swollen/lymph node is bulging/swelling like a outward down), AXILLARY PAIN (Her entire armpit was like a bee stung / states it is painful), PYREXIA (Had a 102 F.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had primary series and first booster dose as PFIZER and 2nd booster shot as Moderna) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Apr-2022, Body temperature: 102 (High) 102 F. The weight of patient was reported as 125 (unit was not reported). Patient had primary series and first booster dose of PFIZER and second booster shot of Moderna. It was reported that patient had swelling of the lymph nodes, lymph nodes were large grape-life and firm under the armpit. She stated it was painful and swollen. She used to put hot water under the arm and it was no longer firm but her entire armpit was like a bee stung. She stated that, the lymph node was not firm anymore and had bulged and swelling like outward down. She was thinking could that possibly be a lymph node rupture. No concomitant and treatment medication information was reported. Company comment: This spontaneous case concerns a 58-year-old female patient with history of interchange of vaccine products, who experienced the unexpected serious (medically significant) event Lymph node rupture, on same day after a dose of mRNA-1273. The patient experienced fever, axillary pain, and enlarged firm lymph nodes in the armpit which subsequently softened after hot fomentation, and she felt that the nodes had ruptured. At the time of reporting, the event outcome was unknown. Previously the patient had taken 3 doses of Pfizer vaccine (inappropriate schedule of vaccine administration). The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 58-year-old female patient with history of interchange of vaccine products, who experienced the unexpected serious (medically significant) event lymph node rupture, on same day after a dose of mRNA-1273. The patient experienced fever, axillary pain, and enlarged firm lymph nodes in the armpit which subsequently softened after hot fomentation, and she felt that the nodes had ruptured. At the time of reporting, the event outcome was unknown. Previously the patient had taken 3 doses of Pfizer vaccine (inappropriate schedule of vaccine administration). The benefit-risk relationship of mRNA-1273 is not affected by this report.