Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyskinesia, Lacrimation increased, Malaise, Muscle twitching
Clinical narrative: After second that night she thought she was going to die for 4 hours; Shakes; Twitches; Jerking/could not control muscles; Eyes were watering constantly; Chills; Drastic (positive) change; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (After second that night she thought she was going to die for 4 hours), TREMOR (Shakes), MUSCLE TWITCHING (Twitches), DYSKINESIA (Jerking/could not control muscles) and LACRIMATION INCREASED (Eyes were watering constantly) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051121A and 059E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sinus infection (In 2017 she had a sinus infection that was treated with steroids and antibiotics.) in 2017 and Leishmaniasis (She lost all her hair, she lost the skin in her nose, her skin was like decaying, she even had wholes in her skin, a whole in her forehead., Six months ago, the infection spread to her kidneys, intestines, lungs. They treated her with an infusion. She does not take opioids or pain medication.). Previously administered products included for Product used for unknown indication: Jexshot in 1992. Past adverse reactions to the above products included Infection with Jexshot. Concurrent medical conditions included Infection (After 7 doses she had a hyperinfection: fungus, mole, Candia).   On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced MALAISE (After second that night she thought she was going to die for 4 hours), TREMOR (Shakes), MUSCLE TWITCHING (Twitches), DYSKINESIA (Jerking/could not control muscles), LACRIMATION INCREASED (Eyes were watering constantly) and CHILLS (Chills). In September 2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Drastic (positive) change). At the time of the report, MALAISE (After second that night she thought she was going to die for 4 hours), TREMOR (Shakes), MUSCLE TWITCHING (Twitches), DYSKINESIA (Jerking/could not control muscles), LACRIMATION INCREASED (Eyes were watering constantly), THERAPEUTIC RESPONSE UNEXPECTED (Drastic (positive) change) and CHILLS (Chills) outcome was unknown.            The patient felt that she was going to die for 4 hours and experienced chills, twitches like jerking could not control muscles. The eyes were watering constantly. The patient  had a drastic (positive) change in what is related to her hyperinfection and would like to know what to expect. The patient was scared of taking the third or booster dose.   Concomitant product use was not provided by the reporter.  Treatment medications include steriod and antibiotics for hyperinfection. The patient was also treated with infusion.   This case was linked to MOD-2021-325597 (Patient Link).; Sender's Comments: This case concerns a female patient of unknown age with a history of Leishmaniasis who experienced the non-serious unexpected events of Dyskinesia, Muscle twitching Chills, Malaise and Tremor the same night of the second dose of Moderna COVID-19 vaccine. Re-challenge is not applicable as this was the second dose. Re-challenge for the first dose was negative as the patient did not experience the same events after the second dose. Of note is that the patient had an event of Therapeutic response unexpected for her condition of Leishmaniasis. Benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.