Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paralysis, Product dose omission issue, Tremor, Weight, Weight decreased
Clinical narrative: some kind of paralyzed with weakness and paralysis on her legs and arms; some kind of paralyzed with weakness and paralysis on her legs and arms; some kind of paralyzed with weakness and paralysis on her legs and arms; late on her most recent dose as she had covid booster shot; some kind of paralyzed with weakness and paralysis on her legs and arms; weakness and left arm are very weak; bad headache; shaky; 130 pounds today she weigh more last year; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022SA196565.  Initial information received on 24May2022 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional. The case involves an unknown age patient who was some kind of paralyzed with weakness and paralysis on legs and arms, weakness and left arm was very weak, bad headache,shaky, 130 pounds today weigh more last year and late on most recent dose as had covid booster shot while being treated with dupilumab [Dupixent] delivered via unknown device along with elasomeran [Moderna covid-19 Vaccine] and Tozinameran [Pfizer covid-19 vaccine]. The patient's past medical history, medical treatment(s), vaccine(s) and family history was not reported. At the time of event, the patient had ongoing Asthma. On 09Mar2022, the patient started taking Dupixent (dupilumab) at a dose of 600 mg IX (once) subcutaneously (Formulation, strength, dosage, route, batch number, expiration date: unknown) followed by maintenance dose of 300 mg QOW (every other week) for atopic dermatis. On 13May2022, the patient started taking Pfizer Biontech covid-19 vaccine (Tozinameran) (Formulation, strength, dosage, route, frequency, batch number, expiration date: unknown) for covid-19 vaccination. On an unknown date patient started taking Moderna covid-19 vaccine (elasomeran) (Formulation, strength, dosage, route, frequency, batch number, expiration date: unknown) for COVID-19 immunisation. On an unknown date, it was reported that patient was late on most recent dose as had covid booster shot (product dose omission issue) on 13May2022 and was down for 12 days did fine with 1st booster shot, feeling better and was able to call us. Had weakness and left arm was very weak (muscular weakness) along with that paralysis on legs and arms and some kind of paralyzed with weakness (monoplegta), shakey (Tremor), bad headache (Headache). She took 500 mg Tylenol (Paracetamol) every 6 hours, to attain a lot of sleep. Nurse also reported the consumer had Pfizer booster shot and also had moderna for dose. Event was carbon copy of 2nd dose of moderna vaccine Pfizer shot was a lot worse when took moderna vaccine already started on taking Dupixent, 130 pounds today weigh more last year (weight decreased) (unknown latency) and Dupixent alo helps with asthma. Relevant laboratory test included. Weight- On an unknown date: [130 pounds today she weigh more last year]. Action taken: Unknown with respect to dupilumab and not applicable with respect to other two suspects. Correction treatment: The patient was treated with paraetamol (Tylenol) for headache and not reported for other events. Outcome: Unknown for all events. Seriousness: Medically significant for event Monoplegia.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive (Withheld) and Pharmacovigilance. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Company Comment: company comment dated 30May2022: This case involves an unknown age patient who was some kind of paralyzed with weaknes and paralysis on legs and arms while being treated with dupilumab (Dupixent). Based on limited information provided regarding this case, causal role of the company suspect product cannot be excluded. However, lack of information of past and concomitant medications, any family history, relevant history of patient any concurrent conditions of the drug precludes comprehensive case assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.