Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, FLUX, UNK, UNK, COVID19
Symptoms: Localised infection, Quadriparesis, Somnolence, Tremor, Upper respiratory tract infection
Clinical narrative: shaky; lot of sleep; infection after the injection; Interchange of vaccine products; bad headache; paralysis in her legs and arm, Muscular weakness; unable to drive again; patient had a flare- up on her left foot; it started on her great and small toe and increased to the top of her left foot, her left ankle was starting to itch; upper respiratory infection, Illness; extremes fatigue, close to a type of paralysis; This spontaneous case was reported by a patient and describes the occurrence of QUADRIPARESIS (paralysis in her legs and arm, Muscular weakness ) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products DUPILUMAB for Atopic dermatitis and Localised infection, DUPILUMAB for Atopic dermatitis, INFLUENZA VACCINE for an unknown indication and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for Prophylactic vaccination.    The patient's past medical history included lung capacity abnormal.  The patient's past medical history included Laryngitis (had a little bit of laryngitis due to air very dry,) and Memory loss. Concomitant products included TERBINAFINE HYDROCHLORIDE (LAMISIL 1) for Eczema, TRIAMCINOLONE for Rash, KETOCONAZOLE for Rash and Eczema, PIMECROLIMUS (ELIDEL) for Rash, Dermatitis atopic and Dermatitis atopic, PARACETAMOL (TYLENOL) for an unknown indication.   In December 2017, the patient started DUPILUMAB (Subcutaneous) 1 dosage form. On 09-Mar-2020, the patient started DUPILUMAB (Subcutaneous) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. In March 2021, the patient experienced UPPER RESPIRATORY TRACT INFECTION (upper respiratory infection, Illness ) and FATIGUE (extremes fatigue, close to a type of paralysis). In April 2021, the patient experienced DERMATITIS ATOPIC (patient had a flare- up on her left foot; it started on her great and small toe and increased to the top of her left foot, her left ankle was starting to itch). On an unknown date, the patient experienced QUADRIPARESIS (paralysis in her legs and arm, Muscular weakness ) (seriousness criterion medically significant), IMPAIRED DRIVING ABILITY (unable to drive again), TREMOR (shaky), SOMNOLENCE (lot of sleep), LOCALISED INFECTION (infection after the injection), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and HEADACHE (bad headache). The patient was treated with DOXYCYCLINE for Dermatitis atopic, at an unspecified dose and frequency and AZITHROMYCIN (Z-PAK) for Viral infection, at an unspecified dose and frequency. At the time of the report, QUADRIPARESIS (paralysis in her legs and arm, Muscular weakness ), IMPAIRED DRIVING ABILITY (unable to drive again), TREMOR (shaky), HEADACHE (bad headache) and FATIGUE (extremes fatigue, close to a type of paralysis) was resolving, UPPER RESPIRATORY TRACT INFECTION (upper respiratory infection, Illness ) and LOCALISED INFECTION (infection after the injection) had resolved and DERMATITIS ATOPIC (patient had a flare- up on her left foot; it started on her great and small toe and increased to the top of her left foot, her left ankle was starting to itch), SOMNOLENCE (lot of sleep) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: 130 130 pounds and 139 139.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered UPPER RESPIRATORY TRACT INFECTION (upper respiratory infection, Illness ) to be related. No further causality assessments were provided for QUADRIPARESIS (paralysis in her legs and arm, Muscular weakness ), IMPAIRED DRIVING ABILITY (unable to drive again), DERMATITIS ATOPIC (patient had a flare- up on her left foot; it started on her great and small toe and increased to the top of her left foot, her left ankle was starting to itch), TREMOR (shaky), SOMNOLENCE (lot of sleep), LOCALISED INFECTION (infection after the injection), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products), HEADACHE (bad headache) and FATIGUE (extremes fatigue, close to a type of paralysis).    Patient reported that he took dupilumab syringe at a loading dose of 600 mg once subcutaneously (strength, batch number, expiry date: unknown) and followed by maintenance dose 300 mg everyother week subcutaneously   On an unknown date in Oct-2020, the patient had an unknown virus (Viral infection- onset date, latency: unknown). Reportedly, patient would get her flu shot the next day and stated that she gets a bad flareup afterwards where her body goes into overdrive. Since New Year (unspecified), the patient had been off of the medication due to insurance but was receiving shipment on Wednesday (date unspecified).  Company comment-This spontaneous case concerns an 78-year-old, female patient with no relevant medical history reported who experienced the unexpected, serious (medically significant) event of  Quadriparesis on an unknown date after receiving second dose of mRNA-1273 vaccine. She also experienced non serious events of Upper respiratory tract infection, Dermatitis atopic, Tremor, Somnolence, Localised infection, Headache and Fatigue. Patient reported upper respiratory tract infection and extreme fatigue in March 2021, followed by a flare up of Dermatitis atopic, with infection in her right lower leg and flare up in left foot due to severe itching and scratching. On an unknown date she took co suspect DUPILUMAB. On an unknown date she had weight loss, with severe muscular weakness and paralysis in her legs and arms associated with tremor, headache and inability to drive. She took Tylenol 500 mg 6th hourly. Patient received Elidel (pimecrolimus) cream, Doxycycline for Dermatitis atopic, antibiotics and dupilumab for localised infection. Interchange of vaccine products was noted as patient has received a dose of co suspect TOZINAMERAN. Patient also had received a dose of mRNA-1273 vaccine on an unknown date. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns an 78-year-old, female patient with no relevant medical history reported who experienced the unexpected, serious (medically significant) event of  Quadriparesis on an unknown date after receiving second dose of mRNA-1273 vaccine. She also experienced non serious events of Upper respiratory tract infection, Dermatitis atopic, Tremor, Somnolence, Localised infection, Headache and Fatigue. Patient reported upper respiratory tract infection and extreme fatigue in March 2021, followed by a flare up of Dermatitis atopic, with infection in her right lower leg and flare up in left foot due to severe itching and scratching. On an unknown date she took co suspect DUPILUMAB. On an unknown date she had weight loss, with severe muscular weakness and paralysis in her legs and arms associated with tremor, headache and inability to drive. She took Tylenol 500 mg 6th hourly. Patient received Elidel (pimecrolimus) cream, Doxycycline for Dermatitis atopic, antibiotics and dupilumab for localised infection. Interchange of vaccine products was noted as patient has received a dose of co suspect TOZINAMERAN. Patient also had received a dose of mRNA-1273 vaccine on an unknown date. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed as per medical judgement.