Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Suicidal ideation, Therapeutic response unexpected
Clinical narrative: feel only a little numbness on their feet/still have the numbness they always have had in their feet, toes, and fingers; I had an adverse reaction to vaccine, it was not compatible with my psychotropics, Geodonsince the reaction I've meltdowns with people giving me poor customer; suicidal thoughts and strong urges to hurt myself ie death; has not gotten the second dose yet/I keep forgetting to go back to get the second dose; feet hurt only on occasion like when cleaning, walked 2 mile; could walk again,neropathy is gone,pain is gone,feel fine, able to walk to bathroom, dance, able to walk the dog on a 5min walk/ the patient has not had to take as much medication that they usually do when they have migraines; still feel tired on their feet "like you have to kick back and relax; This spontaneous case was reported by a consumer and describes the occurrence of SUICIDAL IDEATION (suicidal thoughts and strong urges to hurt myself ie death) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Neuropathy (diagnosed with neuropathy about 4 years ago. The patient stated it was debilitating, they couldn't walk, they crawled, they were in a lot of pain, and nothing they tried helped.), Migraine, Debility, Chronic pain, Crawling sensation and Walking disability. Concomitant products included CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]), PREGABALIN (LYRICA), BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET), LORATADINE (LARITOL), LUMATEPERONE TOSYLATE (CAPLYTA) and ZIPRASIDONE HYDROCHLORIDE (GEODON [ZIPRASIDONE HYDROCHLORIDE]) for an unknown indication.    On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced PAIN IN EXTREMITY (feet hurt only on occasion like when cleaning, walked 2 mile), THERAPEUTIC RESPONSE UNEXPECTED (could walk again,neropathy is gone,pain is gone,feel fine, able to walk to bathroom, dance, able to walk the dog on a 5min walk/ the patient has not had to take as much medication that they usually do when they have migraines) and FATIGUE (still feel tired on their feet "like you have to kick back and relax). On an unknown date, the patient experienced SUICIDAL IDEATION (suicidal thoughts and strong urges to hurt myself ie death) (seriousness criterion medically significant), HYPOAESTHESIA (feel only a little numbness on their feet/still have the numbness they always have had in their feet, toes, and fingers), ADVERSE REACTION (I had an adverse reaction to vaccine, it was not compatible with my psychotropics, Geodonsince the reaction I've meltdowns with people giving me poor customer) and PRODUCT DOSE OMISSION ISSUE (has not gotten the second dose yet/I keep forgetting to go back to get the second dose). At the time of the report, SUICIDAL IDEATION (suicidal thoughts and strong urges to hurt myself ie death), PAIN IN EXTREMITY (feet hurt only on occasion like when cleaning, walked 2 mile), HYPOAESTHESIA (feel only a little numbness on their feet/still have the numbness they always have had in their feet, toes, and fingers), ADVERSE REACTION (I had an adverse reaction to vaccine, it was not compatible with my psychotropics, Geodonsince the reaction I've meltdowns with people giving me poor customer), THERAPEUTIC RESPONSE UNEXPECTED (could walk again,neropathy is gone,pain is gone,feel fine, able to walk to bathroom, dance, able to walk the dog on a 5min walk/ the patient has not had to take as much medication that they usually do when they have migraines) and FATIGUE (still feel tired on their feet "like you have to kick back and relax) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (has not gotten the second dose yet/I keep forgetting to go back to get the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was advised by her psychiatrist not to take the second injection.  No treatment information was provided.  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.  Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Updated information about past medical history, start date of 1st dose of vaccine, additional concomitant medications were added and update the onset date for events and additional events were added On 18-Aug-2021: Significant follow-up received and added new events suicidal intention and adverse event; 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.  Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events. Further information has been requested.