Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Chills, Decreased appetite, Depression, Headache
Clinical narrative: after the vaccine she has started to remember her dreams in detail now; now suffering from depression / she never had before (depression) / depressed only because she is dealing with this; diminished appetite may be due to stress / doctors thinks it might be stress/ look like she has mental issues; did not have any appetite, lost her appetite and that is very unusual/has been eating 1 meal a day, does not feel like eating, does not feel hungry / she had a complete loss of appetite/ going to end up anorexic; Patient was down for 24 hours; little bit of night sweats for few days; her arm swell up really tight; chills; headache; Temperature; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (little bit of night sweats for few days), DECREASED APPETITE (did not have any appetite, lost her appetite and that is very unusual/has been eating 1 meal a day, does not feel like eating, does not feel hungry / she had a complete loss of appetite/ going to end up anorexic), VACCINATION COMPLICATION (Patient was down for 24 hours), ABNORMAL DREAMS (after the vaccine she has started to remember her dreams in detail now) and DEPRESSION (now suffering from depression / she never had before (depression) / depressed only because she is dealing with this) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure abnormal and Blood cholesterol abnormal. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jun-2021, the patient experienced NIGHT SWEATS (little bit of night sweats for few days), VACCINATION COMPLICATION (Patient was down for 24 hours), VACCINATION SITE SWELLING (her arm swell up really tight), CHILLS (chills), HEADACHE (headache) and PYREXIA (Temperature). On 26-Jun-2021, the patient experienced DECREASED APPETITE (did not have any appetite, lost her appetite and that is very unusual/has been eating 1 meal a day, does not feel like eating, does not feel hungry / she had a complete loss of appetite/ going to end up anorexic), DEPRESSION (now suffering from depression / she never had before (depression) / depressed only because she is dealing with this) and STRESS (diminished appetite may be due to stress / doctors thinks it might be stress/ look like she has mental issues). On an unknown date, the patient experienced ABNORMAL DREAMS (after the vaccine she has started to remember her dreams in detail now). At the time of the report, NIGHT SWEATS (little bit of night sweats for few days), ABNORMAL DREAMS (after the vaccine she has started to remember her dreams in detail now), CHILLS (chills) and HEADACHE (headache) outcome was unknown, DECREASED APPETITE (did not have any appetite, lost her appetite and that is very unusual/has been eating 1 meal a day, does not feel like eating, does not feel hungry / she had a complete loss of appetite/ going to end up anorexic), DEPRESSION (now suffering from depression / she never had before (depression) / depressed only because she is dealing with this) and STRESS (diminished appetite may be due to stress / doctors thinks it might be stress/ look like she has mental issues) had not resolved and VACCINATION COMPLICATION (Patient was down for 24 hours), VACCINATION SITE SWELLING (her arm swell up really tight) and PYREXIA (Temperature) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: low (Low) Low.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included medications for cholesterol and Blood Pressure Medicine 10mg.  Patient also mentioned having temperature after the vaccine (high or low not mentioned).  Patient was going back and forth to the emergency room. Every blood work test was normal. Patient was now suffering from depression, which she never had before. Patient was now taking depression medicine and therapy.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, more information is required for further assessment.   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow up information contains patient's current medical conditions, laboratory details, concomitant medications. New events Peripheral swelling, Depression and Stress were added. Events related information and treatment information were added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, more information is required for further assessment.