Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Off label use, Peripheral paralysis
Clinical narrative: paralysis of the right hand; right arm felt weak; one of the fingers on the right hand was curved, paralysis of the right hand; feeling pretty badly; fell and hurt herself; appetite off; muscle pain all over her body; Her mom (patient) received the full 3rd dose which was the same as the first 2 doses. Daughter stated several times that her mother is not immunocompromised.; This spontaneous case was reported by a physician and describes the occurrence of PERIPHERAL PARALYSIS (paralysis of the right hand) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Sep-2021, the patient experienced OFF LABEL USE (Her mom (patient) received the full 3rd dose which was the same as the first 2 doses. Daughter stated several times that her mother is not immunocompromised.). On 30-Sep-2021, the patient experienced DECREASED APPETITE (appetite off) and MYALGIA (muscle pain all over her body). On 07-Oct-2021, the patient experienced FALL (fell and hurt herself). On 08-Oct-2021, the patient experienced FEELING ABNORMAL (feeling pretty badly). On 10-Oct-2021, the patient experienced PERIPHERAL PARALYSIS (paralysis of the right hand) (seriousness criterion medically significant), INJECTION SITE MUSCLE WEAKNESS (right arm felt weak) and FINGER DEFORMITY (one of the fingers on the right hand was curved, paralysis of the right hand). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Muscle pain, at an unspecified dose and frequency. On 21-Sep-2021, OFF LABEL USE (Her mom (patient) received the full 3rd dose which was the same as the first 2 doses. Daughter stated several times that her mother is not immunocompromised.) had resolved. At the time of the report, PERIPHERAL PARALYSIS (paralysis of the right hand), DECREASED APPETITE (appetite off), FALL (fell and hurt herself), FEELING ABNORMAL (feeling pretty badly), INJECTION SITE MUSCLE WEAKNESS (right arm felt weak), FINGER DEFORMITY (one of the fingers on the right hand was curved, paralysis of the right hand) and MYALGIA (muscle pain all over her body) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by reporter.  No treatment information was provided.  Company comment: This case concerns a 85-year-old female patient with no details on previous medical history, who experienced the unexpected serious event of Peripheral paralysis and other non serious events after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). Additionally, off label use was captured. The onset of the event occurred approximately 19 days after the third dose of Spikevax. Clinical manifestations included muscular weakness on the vaccinated arm, finger deformity and paralysis of the hand. The rechallenge is not applicable since no further dose is expected. The benefit-risk relationship of Spikevax vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2021: Significant Follow up- New event added; Sender's Comments: This case concerns a 85-year-old female patient with no details on previous medical history, who experienced the unexpected serious event of Peripheral paralysis and other non serious events after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). Additionally, off label use was captured. The onset of the event occurred approximately 19 days after the third dose of Spikevax. Clinical manifestations included muscular weakness on the vaccinated arm, finger deformity and paralysis of the hand. The rechallenge is not applicable since no further dose is expected. The benefit-risk relationship of Spikevax vaccine is not affected by this report.