Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Interchange of vaccine products, Monoplegia, Tremor, Weight
Clinical narrative: Monoplegia/some kind of paralyzed with weakness and paralysis on her legs and arms; Shaky (tremor); She weighed more last year and recently patient was 130 lbs; bad headache; Patient received mRNA-1273 vaccine as second dose and Covid 19 vaccine Pfizer as booster dose; This spontaneous case was reported by a consumer and describes the occurrence of MONOPLEGIA (Monoplegia/some kind of paralyzed with weakness and paralysis on her legs and arms) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  Co-suspect products included non-company products DUPILUMAB (DUPIXENT) solution for injection for Atopic dermatitis and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.  Concurrent medical conditions included Asthma.  On 09-Mar-2020, the patient DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 600 milligram once a day. On 13-May-2022, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and DUPILUMAB (DUPIXENT) (unknown route) 300 milligram. On an unknown date, the patient experienced MONOPLEGIA (Monoplegia/some kind of paralyzed with weakness and paralysis on her legs and arms) (seriousness criterion medically significant), TREMOR (Shaky (tremor)), WEIGHT DECREASED (She weighed more last year and recently patient was 130 lbs), HEADACHE (bad headache) and INTERCHANGE OF VACCINE PRODUCTS (Patient received mRNA-1273 vaccine as second dose and Covid 19 vaccine Pfizer as booster dose). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, MONOPLEGIA (Monoplegia/some kind of paralyzed with weakness and paralysis on her legs and arms), TREMOR (Shaky (tremor)), WEIGHT DECREASED (She weighed more last year and recently patient was 130 lbs), HEADACHE (bad headache) and INTERCHANGE OF VACCINE PRODUCTS (Patient received mRNA-1273 vaccine as second dose and Covid 19 vaccine Pfizer as booster dose) outcome was unknown.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, Weight: 130 130 pounds (she weigh more last year.).   No concomitant medication was reported by patient.  It was reported that patient had some kind of paralyzed with weakness and paralysis on her legs and arms, weakness and left arm was very weak, bad headache, shaky, 130 pounds on the day it was reported, she weighed more last year and late on her most recent dose as she had covid booster shot while being treated with dupilumab with Moderna covid-19 Vaccine Pfizer biontech covid-19 Vaccine. On 09-Mar-2020, the patient started taking Dupixent (dupilumab) at a dose of 600 mg 1 (once) subcutaneously followed by maintenance dose of 300 mg QOW (every other week) for atopic dermatitis. On an unknown date it was reported that patient was late on her most recent dose as she had covid booster shot (product dose omission issue) on 13-May-2022 and was down for 12 days she did fine with her 1st booster shot, feeling better and was able to call them. She had weakness and left arm was very weak along with that paralysis on her legs and arms and some kind of paralyzed with weakness, shaky, bad headache. She took 500 mg Tylenol (paracetamol) every 6 hours, to attain a lot of sleep. It was also reported that, consumer had Pfizer booster shot and also had Moderna for her dose. It was reported that event was carbon copy of her 2nd dose of moderna vaccine, pfizer shot was a lot worst when she took moderna vaccine she already started on taking Dupixent. It was reported that Dupixent also helped with asthma.  Company Comment: This spontaneous case concerns a female patient with unknown age, with relevant medical history of asthma, who is taking Dupilumab (Dupixent) for Atopic dermatitis given Subcutaneously (also reported as a Co-suspect drug) 600 mg once a day followed by 300 mg every other week as a maintenance dose, who experienced Serious (medically significant), unexpected event of Monoplegia (some kind of paralyzed with weakness and paralysis on her legs and arms) and non-serious, unexpected event of tremor (shaky), weight decreased, non-serous, expected event t of headache (bad headache). These events occurred on an unknown date post vaccination with the 2nd dose of mRNA-1273 vaccine. The details regarding the first dose of Covid 19 vaccine of this patient was not reported but it was mentioned that this patient was given Covid 19 vaccine Pfizer as a booster dose (given 13-05-2022, Co-susupect drug). Event of interchange of Vaccine products also occurred. This patient took Tylenol (paracetamol) 500mg /tab 1 tab every 6 hours to attain a lot of sleep. The details surrounding the events like other treatment information, medical consultation or if any laboratories /diagnostic procedures done were not reported. This report co-insides with the report given by the co-suspect drug reported above of Dupilumab since upon further review this patient received Covid 19 vaccination at the time of treatment with Dupilumab. The outcome of all of the events was reported as unknown. The co-suspect drugs such as Dupilumab and Covid 19 Vaccine Pfizer are considered as confounders for all of the events. The benefit -risk relationship of mRNA -1273 (Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient with unknown age, with relevant medical history of asthma, who is taking Dupilumab (Dupixent) for Atopic dermatitis given Subcutaneously (also reported as a Co-suspect drug) 600 mg once a day followed by 300 mg every other week as a maintenance dose, who experienced Serious (medically significant), unexpected event of Monoplegia (some kind of paralyzed with weakness and paralysis on her legs and arms) and non-serious, unexpected event of tremor (shaky), weight decreased, non-serous, expected event t of headache (bad headache). These events occurred on an unknown date post vaccination with the 2nd dose of mRNA-1273 vaccine. The details regarding the first dose of Covid 19 vaccine of this patient was not reported but it was mentioned that this patient was given Covid 19 vaccine Pfizer as a booster dose (given 13-05-2022, Co-susupect drug). Event of interchange of Vaccine products also occurred. This patient took Tylenol (paracetamol) 500mg /tab 1 tab every 6 hours to attain a lot of sleep. The details surrounding the events like other treatment information, medical consultation or if any laboratories /diagnostic procedures done were not reported. This report co-insides with the report given by the co-suspect drug reported above of Dupilumab since upon further review this patient received Covid 19 vaccination at the time of treatment with Dupilumab. The outcome of all of the events was reported as unknown. The co-suspect drugs such as Dupilumab and Covid 19 Vaccine Pfizer are considered as confounders for all of the events. The benefit -risk relationship of mRNA -1273 (Moderna Covid 19 Vaccine) is not affected by this report.