Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, Movement disorder
Clinical narrative: Patient was treated with Theraflu liquid for COVID-19 treatment; Uncontrolled thrashing of limbs/flailing of arms.Need to pace and keep moving; Patient received first dose on 7-Jan-2021 and second dose on 4-Feb-2022; This spontaneous case was reported by a patient and describes the occurrence of MOVEMENT DISORDER (Uncontrolled thrashing of limbs/flailing of arms.Need to pace and keep moving), COVID-19 (Patient was treated with Theraflu liquid for COVID-19 treatment) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 7-Jan-2021 and second dose on 4-Feb-2022) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 429K20A and 025J20A) for COVID-19 vaccination.    Co-suspect product included non-company product DEXTROMETHORPHAN HYDROBROMIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (THERAFLU [DEXTROMETHORPHAN HYDROBROMIDE;PARACETAMOL;PSEUDOEPHEDRINE HYDROCHLORIDE]) for COVID-19 treatment.    Concurrent medical conditions included Exercise induced asthma and Drug allergy (Compazine family of medication).   On 07-Jan-2021 at 12:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2022 at 12:15 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2022, the patient started DEXTROMETHORPHAN HYDROBROMIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (THERAFLU [DEXTROMETHORPHAN HYDROBROMIDE;PARACETAMOL;PSEUDOEPHEDRINE HYDROCHLORIDE]) (unknown route) at an unspecified dose. On 04-Feb-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 7-Jan-2021 and second dose on 4-Feb-2022). On 27-May-2022 at 4:00 PM, the patient experienced MOVEMENT DISORDER (Uncontrolled thrashing of limbs/flailing of arms.Need to pace and keep moving). On an unknown date, the patient experienced COVID-19 (Patient was treated with Theraflu liquid for COVID-19 treatment). The patient was treated with LORAZEPAM (ATIVAN) at an unspecified dose and frequency and BENZTROPINE [BENZATROPINE] at an unspecified dose and frequency. At the time of the report, MOVEMENT DISORDER (Uncontrolled thrashing of limbs/flailing of arms.Need to pace and keep moving) was resolving and COVID-19 (Patient was treated with Theraflu liquid for COVID-19 treatment) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 7-Jan-2021 and second dose on 4-Feb-2022) outcome was unknown.            Company comment: This is a spontaneous case concerning a 39-year-old male  patient with no relevant medical history, who experienced the non-serious unexpected event of COVID-19 (AESI), approximately 3 months after the administration of second dose of mRNA-1273 vaccine. Clinical course was not provided. Patient receive treatment with Theraflu and adverse event of movement disorder had been reported after this medication. Inappropriate schedule of product administration has been captured, as interval between first and second dose was reported to be 13 months.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Patient's race was reported. No information on concomitant medication was reported.; Sender's Comments: Company comment: This is a spontaneous case concerning a 39-year-old male  patient with no relevant medical history, who experienced the non-serious unexpected event of COVID-19 (AESI), approximately 3 months after the administration of second dose of mRNA-1273 vaccine. Clinical course was not provided. Patient receive treatment with Theraflu and adverse event of movement disorder had been reported after this medication. Inappropriate schedule of product administration has been captured, as interval between first and second dose was reported to be 13 months.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.