Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Groin pain, Malaise, Nausea, Neuralgia
Clinical narrative: really bad nerve pain in her shoulder, arms, wrists that hurt and upper part of legs, back of her thighs; depression; anxiety; chest pain; abdominal pain/slight left abdomen pain; back pain; burning sensation/burning; itching pain; strength has weakned; Stomach burning; no longer fell comfortable; New pains are symmetrical hip/groin pain; ear feels full; urinate frequenlty; burning pain; pain in arms/Feel like my hand strength has weakened and the motor skills in my hands are of; Tingling in spine, shoulders, earlobes, arms, armpits, the skin of my neck,tingles in my scalp, tingling in my calves and heels; burning, tingling, searing pain in top of her spine, in-between her two shoulders, then across of her chest; balance problems, sense of unbalance; cannot walk/cannot walk without stabilizing gait or holding on to something/Cannot sit for long periods of time without balance; dizziness; nausea/a little nausea; burning, tingling, searing pain in right shoulder/in-between her two shoulders/wrist pain; face pain in left sinus and left head; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL PAIN (burning, tingling, searing pain in top of her spine, in-between her two shoulders, then across of her chest), BALANCE DISORDER (balance problems, sense of unbalance), GAIT DISTURBANCE (cannot walk/cannot walk without stabilizing gait or holding on to something/Cannot sit for long periods of time without balance), DIZZINESS (dizziness) and NEURALGIA (really bad nerve pain in her shoulder, arms, wrists that hurt and upper part of legs, back of her thighs) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B211A and 008B21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension (at onset of reaction pressure was low, taken off most BP meds), Penicillin allergy and High cholesterol. Concomitant products included HYDROCHLOROTHIAZIDE from an unknown date to 15-Jun-2021 for Blood pressure high, ATORVASTATIN from 14-Feb-2021 to 15-May-2021 for Cholesterol high, LOSARTAN from an unknown date to 15-Jun-2021 for Hypertension, NADOLOL from 01-Aug-2020 to an unknown date and MAGNESIUM from 01-Aug-2020 to an unknown date for Prophylaxis, CYANOCOBALAMIN (VITAMIN B 12 [CYANOCOBALAMIN]), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), FISH OIL, PROBIOTICS NOS, OMEPRAZOLE and FAMOTIDINE (PEPCID AC) for an unknown indication.   On 25-Mar-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced FACIAL PAIN (face pain in left sinus and left head). On 18-May-2021 at 10:00 PM, the patient experienced SPINAL PAIN (burning, tingling, searing pain in top of her spine, in-between her two shoulders, then across of her chest), BALANCE DISORDER (balance problems, sense of unbalance), GAIT DISTURBANCE (cannot walk/cannot walk without stabilizing gait or holding on to something/Cannot sit for long periods of time without balance), DIZZINESS (dizziness), NAUSEA (nausea/a little nausea) and ARTHRALGIA (burning, tingling, searing pain in right shoulder/in-between her two shoulders/wrist pain). In July 2021, the patient experienced PARAESTHESIA (Tingling in spine, shoulders, earlobes, arms, armpits, the skin of my neck,tingles in my scalp, tingling in my calves and heels), PAIN (burning pain), PAIN IN EXTREMITY (pain in arms/Feel like my hand strength has weakened and the motor skills in my hands are of), URINARY INCONTINENCE (urinate frequenlty), MALAISE (no longer fell comfortable), GROIN PAIN (New pains are symmetrical hip/groin pain) and EAR DISCOMFORT (ear feels full). On an unknown date, the patient experienced NEURALGIA (really bad nerve pain in her shoulder, arms, wrists that hurt and upper part of legs, back of her thighs), DEPRESSION (depression), ANXIETY (anxiety), BURNING SENSATION (burning sensation/burning), CHEST PAIN (chest pain), ABDOMINAL PAIN (abdominal pain/slight left abdomen pain), BACK PAIN (back pain), PRURITUS (itching pain), ASTHENIA (strength has weakned) and DYSPEPSIA (Stomach burning). The patient was treated with CELECOXIB (CELEXA [CELECOXIB]) ongoing since an unknown date for Anxiety, at an unspecified dose and frequency and LORAZEPAM ongoing since an unknown date for Anxiety, at an unspecified dose and frequency. At the time of the report, SPINAL PAIN (burning, tingling, searing pain in top of her spine, in-between her two shoulders, then across of her chest), BALANCE DISORDER (balance problems, sense of unbalance), GAIT DISTURBANCE (cannot walk/cannot walk without stabilizing gait or holding on to something/Cannot sit for long periods of time without balance), DIZZINESS (dizziness) and NAUSEA (nausea/a little nausea) had not resolved, NEURALGIA (really bad nerve pain in her shoulder, arms, wrists that hurt and upper part of legs, back of her thighs), FACIAL PAIN (face pain in left sinus and left head), DEPRESSION (depression), ANXIETY (anxiety), PARAESTHESIA (Tingling in spine, shoulders, earlobes, arms, armpits, the skin of my neck,tingles in my scalp, tingling in my calves and heels), BURNING SENSATION (burning sensation/burning), PAIN (burning pain), CHEST PAIN (chest pain), ABDOMINAL PAIN (abdominal pain/slight left abdomen pain), BACK PAIN (back pain), PAIN IN EXTREMITY (pain in arms/Feel like my hand strength has weakened and the motor skills in my hands are of), PRURITUS (itching pain), URINARY INCONTINENCE (urinate frequenlty), ASTHENIA (strength has weakned), MALAISE (no longer fell comfortable), GROIN PAIN (New pains are symmetrical hip/groin pain), EAR DISCOMFORT (ear feels full) and DYSPEPSIA (Stomach burning) outcome was unknown and ARTHRALGIA (burning, tingling, searing pain in right shoulder/in-between her two shoulders/wrist pain) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 96/77 Low, 125/85 High, 110/88 normal and 125/93 abnormal. On an unknown date, Electromyogram: normal (normal) normal. On an unknown date, Weight decreased: unknown abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient went to ER twice from pain.  Concomitant medication also included blood pressure and headache preventative, 6 weeks of atorvastatin, but stopped it.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Significant follow up, Event, Patient details, Suspect and concomitant drug details updated.