Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral palsy, Complex regional pain syndrome, Pain in extremity, Product dose omission issue
Clinical narrative: Cerebral palsy; Intentional deviation from dosage regimen; Pain was terrible; complex regional pain syndrome; Pain in left leg/Unbearable pain in right leg/Pain in foot; This spontaneous case was reported by a consumer and describes the occurrence of CEREBRAL PALSY (Cerebral palsy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Complex regional pain syndrome (Right leg), Cataract, Reflex sympathetic dystrophy (due to blood clots), Nerve pain (due to blood clots), Cancer surgery and Whipple's operation (Had nerve problems from pancreatic surgery blood clots hemorrhage.). Concurrent medical conditions included Nerve damage (right pelvis from blood clots), Leukemia, Lymphoma, Penicillin allergy, Pancreatic cancer, Haemorrhage (due to pancreatic surgery), Clot blood (due to pancreatic surgery) and Nervous system disorder (due to pancreatic surgery).   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in left leg/Unbearable pain in right leg/Pain in foot). On an unknown date, the patient experienced CEREBRAL PALSY (Cerebral palsy) (seriousness criterion medically significant), PRODUCT DOSE OMISSION ISSUE (Intentional deviation from dosage regimen) and COMPLEX REGIONAL PAIN SYNDROME (Pain was terrible; complex regional pain syndrome). At the time of the report, CEREBRAL PALSY (Cerebral palsy), PAIN IN EXTREMITY (Pain in left leg/Unbearable pain in right leg/Pain in foot), PRODUCT DOSE OMISSION ISSUE (Intentional deviation from dosage regimen) and COMPLEX REGIONAL PAIN SYNDROME (Pain was terrible; complex regional pain syndrome) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided.  This case concerns a 73-year-old female patient  who received first dose of mRNA-1273 and experienced cerebral palsy, pain in left leg/Unbearable pain in right leg/Pain in foot and complex regional pain syndrome  and will not be receiving the 2nd vaccine due to her condition (product dose omission).  Product dose omission is assessed as not applicable and the other events show temporal association between the use of mRNA-1273 and onset, hence a causal relationship cannot be excluded.   This case was linked to MOD-2021-258012 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Jul-2021: Follow up report was received, and include information for new events and procedure. On 17-Jul-2021: Upon internal review on 20-SEP-2022 non significant corrections performed to update case received from field.; Sender's Comments: This case  concerns a 73-year-old female patient  who received first dose of mRNA-1273 and experienced cerebral palsy, pain in left leg/Unbearable pain in right leg/Pain in foot and complex regional pain syndrome  and will not be receiving the 2nd vaccine due to her condition (product dose omission).  Product dose omission is assessed as not applicable and the other events show temporal association between the use of mRNA-1273 and onset, hence a causal relationship cannot be excluded.