Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Covid19; Lack of drug effect; swelling in the left side of the neck/felt like a lot fluid in neck/fluid may be filling up/swollen lymph node from the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swelling in the left side of the neck/felt like a lot fluid in neck/fluid may be filling up/swollen lymph node from the vaccine), COVID-19 (Covid19) and DRUG INEFFECTIVE (Lack of drug effect) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039C21A and 033C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (Took lowdose blood pressure medicine). Concomitant products included ATORVASTATIN for an unknown indication.   On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYMPHADENOPATHY (swelling in the left side of the neck/felt like a lot fluid in neck/fluid may be filling up/swollen lymph node from the vaccine). In January 2022, the patient experienced COVID-19 (Covid19) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, LYMPHADENOPATHY (swelling in the left side of the neck/felt like a lot fluid in neck/fluid may be filling up/swollen lymph node from the vaccine), COVID-19 (Covid19) 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) tested positive.         Caller reported a couple days after getting the second dose, they were in the Emergency hospital around 06July2021 due to a swelling in the left side of the neck, felt like a lot fluid in neck, fluid may be filling up. Caller reported at the hospital they checked everything out and said it was a swollen lymph node from the vaccine.  No treatment information was provided by the reporter.  Company Comment: This spontaneous case concerns a 56-year-old female patient, with no relevant medical history, who experienced the unexpected non-serious events of left cervical Lymphadenopathy, COVID-19 (AESI), and Drug ineffective. The event Lymphadenopathy occurred approximately 4 days after the second dose of mRNA-1273 vaccine (02July2021), administered 27 days after the first dose (05June2021), while events COVID-19 and Drug ineffective occurred unknown number of days after the vaccination. According to the patient, she was in the Emergency hospital approximately 4 days after vaccination due to a swelling in the left side of the neck, it felt like there was a lot of fluid in neck or that fluid may be filling up. Patient was checked and was told that it was a swollen lymph node from the vaccine. COVID-19 PCR test was positive in JAN2022. There was no available information regarding clinical course and treatment medication. There was also no other information regarding the first dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2022: Follow up received contains no new information.; Sender's Comments: This spontaneous case concerns a 56-year-old female patient, with no relevant medical history, who experienced the unexpected non-serious events of left cervical Lymphadenopathy, COVID-19 (AESI), and Drug ineffective. The event Lymphadenopathy occurred approximately 4 days after the second dose of mRNA-1273 vaccine (02July2021), administered 27 days after the first dose (05June2021), while events COVID-19 and Drug ineffective occurred unknown number of days after the vaccination. According to the patient, she was in the Emergency hospital approximately 4 days after vaccination due to a swelling in the left side of the neck, it felt like there was a lot of fluid in neck or that fluid may be filling up. Patient was checked and was told that it was a swollen lymph node from the vaccine. COVID-19 PCR test was positive in JAN2022. There was no available information regarding clinical course and treatment medication. There was also no other information regarding the first dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.