Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Agitation, Anxiety, Asthenia, Autonomic nervous system imbalance, Bipolar disorder
Clinical narrative: I've been exploring ketamine, TMS, therapy guided psilocybin or MDMA treatment, and even ECT; Obsessively ponder ways to kill myself; She feels she is a bipolar; Mental disorder; Agitation; Panicked/ Fear; Anxiety; Rapid heart rate; ANS/ Psychic distress/ Somatic symptom; Weak feelings in my legs; Numbness in my arms; Sweating; Sleepless; Generalized weakness; psychiatric illness; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DRUG ABUSE (I've been exploring ketamine, TMS, therapy guided psilocybin or MDMA treatment, and even ECT) and SUICIDAL IDEATION (Obsessively ponder ways to kill myself) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included ESTRIOL and ECSTASY for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DRUG ABUSE (I've been exploring ketamine, TMS, therapy guided psilocybin or MDMA treatment, and even ECT) (seriousness criterion medically significant), SUICIDAL IDEATION (Obsessively ponder ways to kill myself) (seriousness criterion medically significant), BIPOLAR DISORDER (She feels she is a bipolar), MENTAL DISORDER (Mental disorder ), AGITATION (Agitation), PANIC REACTION (Panicked/ Fear), ANXIETY (Anxiety), TACHYCARDIA (Rapid heart rate), AUTONOMIC NERVOUS SYSTEM IMBALANCE (ANS/ Psychic distress/ Somatic symptom), MUSCULAR WEAKNESS (Weak feelings in my legs), HYPOAESTHESIA (Numbness in my arms), HYPERHIDROSIS (Sweating), INSOMNIA (Sleepless), ASTHENIA (Generalized weakness), PSYCHOTIC DISORDER (psychiatric illness) and NAUSEA (Nausea). The patient was treated with GABAPENTIN at a dose of 1 dosage form; LORAZEPAM at a dose of 1 dosage form; FLUOXETINE at a dose of 1 dosage form and KETAMINE at a dose of 1 dosage form. At the time of the report, DRUG ABUSE (I've been exploring ketamine, TMS, therapy guided psilocybin or MDMA treatment, and even ECT), SUICIDAL IDEATION (Obsessively ponder ways to kill myself), BIPOLAR DISORDER (She feels she is a bipolar), MENTAL DISORDER (Mental disorder ), AGITATION (Agitation), PANIC REACTION (Panicked/ Fear), ANXIETY (Anxiety), TACHYCARDIA (Rapid heart rate), AUTONOMIC NERVOUS SYSTEM IMBALANCE (ANS/ Psychic distress/ Somatic symptom), MUSCULAR WEAKNESS (Weak feelings in my legs), HYPOAESTHESIA (Numbness in my arms), HYPERHIDROSIS (Sweating), INSOMNIA (Sleepless), ASTHENIA (Generalized weakness), PSYCHOTIC DISORDER (psychiatric illness) and NAUSEA (Nausea) outcome was unknown.            Other treatment information includes Mood stabilizer, Tranquilizer, Benzo diazepam, Atypical Antipsychotics, Transcranial magnetic stimulation therapy, Electroconvulsive therapy. Action taken with mRNA-1273 in response to the events was not applicable.  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.   This case was linked to MOD-2021-073191 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow up was received on 15-JUN-2021 contains significant information. Vaccine dose details, Concomitant, Treatment medications and Events include: Panic reaction, Tachycardia, Autonomic nervous system imbalance, Muscular weakness, Hypoaesthesia, Hyperhidrosis, Nausea were added. On 21-Jun-2021: Follow up received on 21-Jun-2021 contains no new information. On 03-Jul-2021: Follow up information was received from initial reporter: It was reported that the patient not a bipolar and mental disorder and never been diagnosed or treated for bipolar disorder. It was also reported that the patient was on no medication and not under recent psychiatric care prior to getting Moderna COVID vaccine. The patient reported that the Moderna vaccine elicited a full body response that has affected nervous system. This case was upgraded from non-serious to serious due to the events Drug abuse and Suicidal ideation (Medically significant); 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.