Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, SARS-CoV-2 test
Clinical narrative: she still has the night sweats quite frequently with low grade fever and headaches; Covid-19 (fever, chills, sweats, Hyperhidrosis and cough); This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid-19 (fever, chills, sweats, Hyperhidrosis and cough)) and HEADACHE (she still has the night sweats quite frequently with low grade fever and headaches) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066N21A, 030L20A and 015M20A) for COVID-19 vaccination.     The patient's past medical history included Bladder cancer (15 years ago) and Splenectomy (spleen was taken out many years ago (prior to getting the Covid-19 vaccine)). Previously administered products included for Immunisation: flu vaccine in 2021. Past adverse reactions to the above products included No adverse event with flu vaccine. Concurrent medical conditions included High cholesterol, Hypertension and Immunocompromised (autoimmune disease (not specified)). Concomitant products included PRAVASTATIN for High cholesterol, METOPROLOL for Hypertension.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In January 2022, the patient experienced COVID-19 (Covid-19 (fever, chills, sweats, Hyperhidrosis and cough)). On an unknown date, the patient experienced HEADACHE (she still has the night sweats quite frequently with low grade fever and headaches). At the time of the report, COVID-19 (Covid-19 (fever, chills, sweats, Hyperhidrosis and cough)) outcome was unknown and HEADACHE (she still has the night sweats quite frequently with low grade fever and headaches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: positive (Positive) Positive.         The patient had no allergies. The patient had autoimmune disease, when asked about specific autoimmune disease she said it was because she no longer had a spleen so she had it. The patient received third dose at full dose as she was immunocompromised. The patient had Covid-19 in Jan2022 where she stayed home and was quite sick with fever and chills and tremendous sweats and cough. The cough lingered for awhile and resolved. The patient stated she had tons of night sweats but had started to live with that. That just occurred to her that she never had it prior to getting Covid-19 disease. The patient had not consulted her primary doctor regarding the ongoing symptoms and did not seek medical care. No treatment drug was reported.  Company Comment: This is a spontaneous case concerning a 77-year-old female patient with medical history of bladder cancer, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 4 months after receiving the third dose of mRNA-1273 vaccine. The patient reported fever and chills, sweats and cough. The cough resolved but the patient still experiencing night sweats associated with low grade fever and headaches. Exact onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown. The first two doses of mRNA-1273 was given on a 28-day interval with the second dose administered approximately 6 months prior to the third dose of mRNA-1273. Medical history of bladder cancer remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 77-year-old female patient with medical history of bladder cancer, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 4 months after receiving the third dose of mRNA-1273 vaccine. The patient reported fever and chills, sweats and cough. The cough resolved but the patient still experiencing night sweats associated with low grade fever and headaches. Exact onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown. The first two doses of mRNA-1273 was given on a 28-day interval with the second dose administered approximately 6 months prior to the third dose of mRNA-1273. Medical history of bladder cancer remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.