Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Tremor
Clinical narrative: severe pain in the back/diagnosed with lumbar pain; severe pain in the back; diagnosed with high blood pressure (180/106); diagnosed with neuropathy; tremor in her leg /tremors felt above the knee; pain in the neck; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (severe pain in the back/diagnosed with lumbar pain), BACK PAIN (severe pain in the back), HYPERTENSION (diagnosed with high blood pressure (180/106)), NEUROPATHY PERIPHERAL (diagnosed with neuropathy) and TREMOR (tremor in her leg /tremors felt above the knee) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced BACK PAIN (severe pain in the back) (seriousness criterion hospitalization), HYPERTENSION (diagnosed with high blood pressure (180/106)) (seriousness criterion hospitalization) and NEUROPATHY PERIPHERAL (diagnosed with neuropathy) (seriousness criteria hospitalization and medically significant). On 28-Aug-2021, the patient experienced BACK PAIN (severe pain in the back/diagnosed with lumbar pain) (seriousness criterion hospitalization). On an unknown date, the patient experienced TREMOR (tremor in her leg /tremors felt above the knee) (seriousness criterion medically significant) and NECK PAIN (pain in the neck). The patient was hospitalized from 10-May-2021 to 10-May-2021 due to HYPERTENSION and NEUROPATHY PERIPHERAL, then from 28-Aug-2021 to 28-Aug-2021 due to BACK PAIN, then from 28-Aug-2021 to 28-Aug-2021 due to BACK PAIN The patient was treated with GABAPENTIN for Adverse event, at a dose of 100 mg twice a day; GABAPENTIN for Adverse event, at a dose of 100 mg once a day; GABAPENTIN for Adverse event, at a dose of UNK UNK, tid; TRAMADOL for Adverse event, at an unspecified dose and frequency; ALLOPURINOL for Adverse event, at a dose of UNK UNK, bid; MORPHINE for Back pain, at an unspecified dose and frequency and LIDOCAINE (LIDODERM) for Back pain, at an unspecified dose and frequency. On 10-May-2021, BACK PAIN (severe pain in the back) and NEUROPATHY PERIPHERAL (diagnosed with neuropathy) had resolved. On 28-Aug-2021, BACK PAIN (severe pain in the back/diagnosed with lumbar pain) had resolved. At the time of the report, HYPERTENSION (diagnosed with high blood pressure (180/106)), TREMOR (tremor in her leg /tremors felt above the knee) and NECK PAIN (pain in the neck) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2021, Blood pressure measurement: 180/106 (High) high blood pressure (180/106). On 10-May-2021, Blood uric acid: elevated (High) elevated uric acid in the blood.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 10-May-2021, there were other lab tests performed such as, CBC auto differential, CMP, C-reactive protein, magnesium, microscopic urine, POTC urine analysis dip stick, Sedition rate, PSH, Us doppler venous of the leg on the left, no results provided. Patient also stated they will have MRI test. Patient experienced electric pain on both legs, both feet ,hands and ankle which just felt like shock. Patient stated that the prescriber called this as peripheral nerve disease. Patient was prescribe Morphine in the back as well as Lidoderm patches. Patient was diagnosed with Lumbar pain and discharge the same day. Patient stated the prescriber is calling this as a peripheral nerve disease.  Company comment This case concerns a 65-year-old female patient with no medical history reported, who experienced the unexpected, serious (hospitalization and medically significant) events of hypertension, neuropathy peripheral, tremor, back pain and neck pain. The events occurred approximately 67 days after the first dose of mRNA-1273 and 36 after the second dose of mRNA-1273. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-363400 (Patient Link).; Sender's Comments: This case concerns a 65-year-old female patient with no medical history reported, who experienced the unexpected, serious (hospitalization and medically significant) events of hypertension, neuropathy peripheral, tremor, back pain and neck pain. The events occurred approximately 67 days after the first dose of mRNA-1273 and 36 after the second dose of mRNA-1273. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.