Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood pressure measurement, Hypoaesthesia, Impaired work ability, Inner ear inflammation
Clinical narrative: She started not being able to remember anything/She had extreme forgetfulness; she couldn't spell "world" backwards/inability to form sentences; Neurologic symptoms/ Not being able to remember anything/ Extreme forgetfulness and inability to form sentences; Relapsing polychondritis; Numbness; Tingling; Pain in the back of head down neck and spine; Muscle twitch; Spasms in my legs; No longer able to work anymore; Tremors in legs; Developed weakness (in my legs); Redness, inflammation and severe pain inside both ears; This spontaneous case was reported by a consumer and describes the occurrence of NEUROLOGICAL SYMPTOM (Neurologic symptoms/ Not being able to remember anything/ Extreme forgetfulness and inability to form sentences), MEMORY IMPAIRMENT (She started not being able to remember anything/She had extreme forgetfulness), SPEECH DISORDER (she couldn't spell "world" backwards/inability to form sentences) and POLYCHONDRITIS (Relapsing polychondritis) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.    On 25-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2021, the patient experienced INNER EAR INFLAMMATION (Redness, inflammation and severe pain inside both ears). In February 2021, the patient experienced MUSCULAR WEAKNESS (Developed weakness (in my legs)). In March 2021, the patient experienced TREMOR (Tremors in legs). In April 2021, the patient experienced NEUROLOGICAL SYMPTOM (Neurologic symptoms/ Not being able to remember anything/ Extreme forgetfulness and inability to form sentences) (seriousness criterion hospitalization), MEMORY IMPAIRMENT (She started not being able to remember anything/She had extreme forgetfulness) (seriousness criterion hospitalization) and SPEECH DISORDER (she couldn't spell "world" backwards/inability to form sentences) (seriousness criterion hospitalization). On an unknown date, the patient experienced POLYCHONDRITIS (Relapsing polychondritis) (seriousness criterion medically significant), HYPOAESTHESIA (Numbness), PARAESTHESIA (Tingling), BACK PAIN (Pain in the back of head down neck and spine), MUSCLE TWITCHING (Muscle twitch), MUSCLE SPASMS (Spasms in my legs) and IMPAIRED WORK ABILITY (No longer able to work anymore). The patient was hospitalized on sometime in April 2021 due to NEUROLOGICAL SYMPTOM. The patient was treated with HYDROXYCHLOROQUINE for Adverse event, at a dose of 400 milligram once a day; METHYLPREDNISOLONE ongoing since an unknown date for Adverse event, at a dose of 12 milligram once a day; GABAPENTIN (NEURONTIN) for Adverse event, at a dose of 300 milligram; ACETYLSALICYLIC ACID (BABY ASPIRIN) for Adverse event, at an unspecified dose and frequency; PREDNISONE for Adverse event, at an unspecified dose and frequency and MELOXICAM for Pain, at a dose of 15 milligram. At the time of the report, NEUROLOGICAL SYMPTOM (Neurologic symptoms/ Not being able to remember anything/ Extreme forgetfulness and inability to form sentences), MEMORY IMPAIRMENT (She started not being able to remember anything/She had extreme forgetfulness), SPEECH DISORDER (she couldn't spell "world" backwards/inability to form sentences), POLYCHONDRITIS (Relapsing polychondritis), TREMOR (Tremors in legs), INNER EAR INFLAMMATION (Redness, inflammation and severe pain inside both ears), MUSCULAR WEAKNESS (Developed weakness (in my legs)), HYPOAESTHESIA (Numbness), PARAESTHESIA (Tingling), BACK PAIN (Pain in the back of head down neck and spine), MUSCLE TWITCHING (Muscle twitch), MUSCLE SPASMS (Spasms in my legs) and IMPAIRED WORK ABILITY (No longer able to work anymore) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: decreased (Low) decreased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Within a couple days after the second shot, the patient got redness, inflammation, and severe pain inside both ears. On an unknown date in Feb-2021, the patient developed weakness. On an unknown date in Mar-2021, the patient developed tremors in legs, numbness and tingling, and pain in the back of head down neck and spine. The patient never had pain in back in spin before. The patient had muscle twitches and spasms in legs. On an unknown date in Apr-2021, the patient was in the hospital for a week with neurologic symptoms. The patient was not able to remember anything, could not spell 'world' backwards, had extreme forgetfulness and inability to form sentences. The patient still had difficulty with that. The blood pressure kept dropping, which was never issue before. The patient was no longer able to work anymore. The patient was started on hydroxychloroquine because it looked like relapsing polychondritis.  Since vaccination, the condition had been continually worsening. The patient has seen a million different specialists, and no one seems to know what was going on. It had been months now.  Company comment: This case concerns a 28 year old female patient, with no medical history reported, who experienced serious unexpected events of neurological symptoms, Memory impairment and Speech disorder after second dose of mRNA-1273. The events occurred approximately 2 months after second dose of mRNA-1273. The re-challenge is not applicable as no further dose is expected to be given. The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-345526 (Patient Link).; Sender's Comments: This case concerns a 28 year old female patient, with no medical history reported, who experienced serious unexpected events of neurological symptoms, Memory impairment and Speech disorder after second dose of mRNA-1273. The events occurred approximately 2 months after second dose of mRNA-1273. The re-challenge is not applicable as no further dose is expected to be given. The benefit-risk relationship of Spikevax is not affected by this report.