Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood calcium, Blood parathyroid hormone, Depressed mood, Fear, Osteoporosis
Clinical narrative: Fears if she may be allergic to the Moderna vaccine; During the call the patient was emotional; Diagnosed with osteoporosis; Flinched her body after recieving second dose / possible improper injection administration; Has a disability in which her right side of body she experiences paralysis at night and was ongoing since recieving the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (Has a disability in which her right side of body she experiences paralysis at night and was ongoing since recieving the second dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vitamin D deficiency (Has low vitamin D deficiency which was pre existing to the Moderna vaccine) and Post-traumatic stress disorder. Concurrent medical conditions included Hypertension and Drug allergy (Allergy to blood pressure medication and went 13 years without doctors discovering it).   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PARALYSIS (Has a disability in which her right side of body she experiences paralysis at night and was ongoing since recieving the second dose) (seriousness criterion medically significant) and PRODUCT ADMINISTRATION ERROR (Flinched her body after recieving second dose / possible improper injection administration). On 13-Aug-2021, the patient experienced OSTEOPOROSIS (Diagnosed with osteoporosis). On 09-Nov-2021, the patient experienced DEPRESSED MOOD (During the call the patient was emotional). On an unknown date, the patient experienced FEAR (Fears if she may be allergic to the Moderna vaccine). On 06-Apr-2021, PRODUCT ADMINISTRATION ERROR (Flinched her body after recieving second dose / possible improper injection administration) had resolved. At the time of the report, PARALYSIS (Has a disability in which her right side of body she experiences paralysis at night and was ongoing since recieving the second dose), DEPRESSED MOOD (During the call the patient was emotional), FEAR (Fears if she may be allergic to the Moderna vaccine) and OSTEOPOROSIS (Diagnosed with osteoporosis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Blood parathyroid hormone: low (Low) She had bloodwork on May 2021 in which her PTH levels were low then went to 120. In 2021, Blood calcium: low (Low) Low calcium level.         The concomitant medications reported included medications for hypertension.  Treatment information was not provided.  The patient reported that in 2018 she was hospitalized and went 13 years without doctors discovering that she was allergic to blood pressure medication. She also fears that she may be allergic to Moderna vaccine. The patient flinched her body after receiving the second dose and was not aware whether this has to do with paralysis, she experiences from possible improper injection administration.  Company Comment: This case concerns a 65-year-old female patient with no relevant medical history, who experienced the unexpected event of Paralysis. The event occurred the same day after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the second dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Follow up received contains additional event. On 10-Nov-2021: Follow up received contains no new information.; Sender's Comments: This case concerns a 65-year-old female patient with no relevant medical history, who experienced the unexpected event of Paralysis. The event occurred the same day after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the second dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.