Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Restlessness, Therapeutic response unexpected, White blood cell count increased
Clinical narrative: Diarrhea; Tingling in arms/Tingling in legs; Sore throat; reported history of back injury in 1998 and stated that all of this is now active; his white cell count went up by 20,000 to a total of 75,000; having an overstimulated, enhanced, magnified, and amplified response to the vaccine 14 days later after receiving the vaccine; Headache; Fatigue; Neuropathy; Has crazy exaggerated dreams; feels terrible/ brain fog; feels like he has a full blown flu infection; unable to sleep/Cannot sleep/Trouble sleeping; Restless; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy), INSOMNIA (unable to sleep/Cannot sleep/Trouble sleeping), RESTLESSNESS (Restless), ABNORMAL DREAMS (Has crazy exaggerated dreams) and FEELING ABNORMAL (feels terrible/ brain fog) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included CLL. Concomitant products included IBUPROFEN for an unknown indication.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced INSOMNIA (unable to sleep/Cannot sleep/Trouble sleeping) and RESTLESSNESS (Restless). On 11-Aug-2021, the patient experienced FEELING ABNORMAL (feels terrible/ brain fog) and INFLUENZA LIKE ILLNESS (feels like he has a full blown flu infection). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy), ABNORMAL DREAMS (Has crazy exaggerated dreams), DIARRHOEA (Diarrhea), PARAESTHESIA (Tingling in arms/Tingling in legs), OROPHARYNGEAL PAIN (Sore throat), MUSCULOSKELETAL DISCOMFORT (reported history of back injury in 1998 and stated that all of this is now active), WHITE BLOOD CELL COUNT INCREASED (his white cell count went up by 20,000 to a total of 75,000), THERAPEUTIC RESPONSE UNEXPECTED (having an overstimulated, enhanced, magnified, and amplified response to the vaccine 14 days later after receiving the vaccine), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy), INSOMNIA (unable to sleep/Cannot sleep/Trouble sleeping), RESTLESSNESS (Restless), ABNORMAL DREAMS (Has crazy exaggerated dreams), FEELING ABNORMAL (feels terrible/ brain fog), INFLUENZA LIKE ILLNESS (feels like he has a full blown flu infection), DIARRHOEA (Diarrhea), PARAESTHESIA (Tingling in arms/Tingling in legs), OROPHARYNGEAL PAIN (Sore throat), MUSCULOSKELETAL DISCOMFORT (reported history of back injury in 1998 and stated that all of this is now active), WHITE BLOOD CELL COUNT INCREASED (his white cell count went up by 20,000 to a total of 75,000), THERAPEUTIC RESPONSE UNEXPECTED (having an overstimulated, enhanced, magnified, and amplified response to the vaccine 14 days later after receiving the vaccine), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       the reporter reported that the patient felt similar to when he had a lymphoblastic surge when his lymphocytes went up to 105,000.  No concomitant medication was reported.  No treatment medication was reported by the reporter.  The patient has trouble sleeping as he cannot sleep, is restless, has crazy exaggerated dreams, neuropathy and diarrhea. The patient also mentioned having tingling in arms and legs and believes its neuropathy. The patient stated that he has history of cancer ("chronic "leukotosis" leukemia") that is unmutated. The patient believes that his antibodies are having trouble due to his cancer. The patient stated that his symptoms of headache, sore throat and fatigue went away (lot of other stuff has subsided). The patient reported history of back injury in 1998 and stated that all of this is now active. Patient stated that upon his blood test with hematologist, his white cell count went up by 20,000 to a total of 75,000.  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, patient's medical history of chronic lymphocytic leukemia could be a confounder for the events. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: Followup received contains information about  past medical history, concomitant medication , events information.; 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, patient's medical history of chronic lymphocytic leukemia could be a confounder for the events. Further information has been requested.