Received Jan 20, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 1 | — | — |
acute disseminated encephalomyelitis (ADEM); positive for Mycoplasma pneumonia IgM and IgG; This literature-non-study case was reported in a literature article and describes the occurrence of ACUTE DISSEMINATED ENCEPHALOMYELITIS (acute disseminated encephalomyelitis (ADEM)) and MYCOPLASMA INFECTION (positive for Mycoplasma pneumonia IgM and IgG) in a 44-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. LITERATURE REFERENCE: The patient's past medical history included Renal stone. Concurrent medical conditions included Anxiety, Hyperlipidemia and Hypothyroidism. Concomitant products included Levothyroxine for an unknown indication. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACUTE DISSEMINATED ENCEPHALOMYELITIS (acute disseminated encephalomyelitis (ADEM)) (seriousness criteria hospitalization and medically significant) and MYCOPLASMA INFECTION (positive for Mycoplasma pneumonia IgM and IgG) (seriousness criteria hospitalization and medically significant). The patient was treated with Methylprednisolone sodium succinate (Solumedrol) (intravenous use) at a dose of 500 milligram twice a day; Prednisone (oral use) at a dose of 60 milligram, tapered by half every three days; Gabapentin for Back pain, at a dose of UNK UNK, prn; Baclofen for Back pain, at a dose of UNK UNK, prn and Surgery (plasmapheresis and plasma exchange) for Acute disseminated encephalomyelitis. At the time of the report, ACUTE DISSEMINATED ENCEPHALOMYELITIS (acute disseminated encephalomyelitis (ADEM)) had resolved and MYCOPLASMA INFECTION (positive for Mycoplasma pneumonia IgM and IgG) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Albumin CSF (8.0-42.0 mg/dl): 59 mg/dl. On an unknown date, Angiotensin converting enzyme (Unknown-15): 6 p/mol/L/min. On an unknown date, Blood immunoglobulin A (Unknown-0.6 mg/dl): 1.8 mg/dl CSF. On an unknown date, Blood immunoglobulin G (0.8-7.7 mg/dl): 11.6 mg/dl CSF. On an unknown date, Blood immunoglobulin M (Unknown-0.5 mg/dl): 1.8 mg/dl CSF. On an unknown date, Blood potassium: 3.4 milliequivalent per litre. On an unknown date, CSF glucose (40-70 mg/dl): 66 mg/dl. On an unknown date, CSF myelin basic protein (2.0-4.0 microgram per litre): 10.2 microgram per litre. On an unknown date, CSF protein (15-40 mg/dl): 98 mg/dl. On an unknown date, CSF red blood cell count (0-5 cells): 7 cells. On an unknown date, CSF white blood cell count (0-10 cells): 105 cells. On an unknown date, Computerised tomogram head: Showed a 2.4 cm low-density mass in anterior left frontal lobe along with multiple supratentorial and infratentorial lesions consistent with demyelinating disease either multiple sclerosis (MS) or acute disseminated encephalomyelitis (ADEM). On an unknown date, Cryptococcus test: Negative. On an unknown date, Cytomegalovirus test (Unknown-30): less than 30 mg/dL and Negative. On an unknown date, Epstein-Barr virus test (Unknown-200 international unit per millilitre): 693 international unit per millilitre. On an unknown date, HIV test: Non-reactive. On an unknown date, Herpes simplex test: Negative. On an unknown date, Influenza A virus test: Negative. On an unknown date, Influenza B virus test: Negative. On an unknown date, Magnetic resonance imaging head: showed multifocal supratentorial predominantly periventricular lesions with a single lesion in right upper cervical cord and an enhancing 17 mm lesion in left frontal white matter with surrounding edema, again findings consistent with demyelinating disease, showed an enhancing 17.3 mm lesion in the left frontal white matter with surrounding edema, Showed improvement, previous lesions seemed to decrease in size or resolved (After 14 days) and Showed resolution of previously reported demyelinating lesions and no new demyelinating lesions (Six months later). On an unknown date, Magnetic resonance imaging spinal: Shows diffuse abnormal central cord signal intensity throughout thoracic spine, extending into cervical cord and conus with focal enhancement in left central region at T7-T8 level. Multifocal and diffuse abnormal central cord signal intensity beginning at C3-C4 extending into thoracic spine with focal sparing at C5-C6. Diffuse abnormal central cord signal intensity throughout thoracic spine was favoring ADEM considering recent MRI brain findings, Showed improvement, previous lesions seemed to decrease in size or resolved (After 14 days), Showed resolution of previously reported demyelinating lesions and no new demyelinating lesions (Six months later) and T2 MRI lumbar spine with and without contrast showed a 12 mm lesion in conus at T11-12 level consistent with an active demyelinating plaque. On an unknown date, Mycoplasma test (Unknown-0.90 mg/dl): 4.07 mg/dl, 1943 mg/dl, Positive and Positive. On an unknown date, Oligoclonal band assay: No bands. On an unknown date, Ophthalmological examination: Repeatedly found sable. On an unknown date, Physical examination: showed muscle strength 1/5, 0 deep tendon reflexes of bilateral lower extremities, bilateral and equal diminished sensation to touch and pinprick, and sensory level at T3. Gait couldn't be checked since she wasn't able to stand, rest of the physical examination was otherwise normal. On an unknown date, SARS-CoV-2 antibody test (Unknown-1.39 mg/dl): 0.09 mg/dl. On an unknown date, SARS-CoV-2 test: (Negative) tested for coronavirus disease 2019 (COVID-19) by polymerase chain reaction (PCR)-RNA test twice weekly, and never had a positive result. On an unknown date, Syphilis test: Non-reactive and Non-reactive in CSF. On an unknown date, Varicella virus test: Not detected. On an unknown date, Visual field tests: Visual field test showed blind spot, ceco-central scotoma in both eyes. On an unknown date, Vital signs measurement: On arrival vital signs were stable. On an unknown date, West Nile virus test: West Nile Ab IgG, CSF- less than 1.30 and West Nile Ab IgM, CSF- less than 0.90. On an unknown date, White blood cell count: 12.1 x1,000/mL Mild leucocytosis. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter considered ACUTE DISSEMINATED ENCEPHALOMYELITIS (acute disseminated encephalomyelitis (ADEM)) to be related. No further causality assessment was provided for MYCOPLASMA INFECTION (positive for Mycoplasma pneumonia IgM and IgG). This case was identified during a retrospective clean-up activity initiated under CAPA in response to a Health Inspection Observation. Patient went to the emergency room (ER) with complaints of numbness and weakness in both legs. The patient reported that she was completely well. The previous day, she went to a massage therapist, and the next day she started having tingling and numbness along with weakness in both lower extremities, she also endorsed urinary retention, blurred vision in right eye, and midline lower back pain. Symptoms gradually got worse until she was barely able to move both lower extremities, she got concerned with all these and went to ER. She denied fever, chills, headache, nuchal rigidity, nausea, vomiting, chest pain, shortness of breath, trouble with speech, facial droop, any trauma, recent infection, or similar complaints in the past. She did receive SARS-CoV-2 mRNA vaccine first dose six days prior to presentation. Speech and swallow evaluations were done, and she did not have any signs or symptoms of aspiration. Meningoencephalitis panel, neuromyelitis optica (NMO) antibody, Lyme antibody, Malignant cells in CSF test were negative. Further workup was done to rule out other potential diagnoses and causes of ADEM. After treatment patient gradually showed slow improvement, was able to wiggle her toes and later move her feet and was medically stable enough to go to rehab. She still had bilateral lower extremity weakness, tingling and numbness, blurred vision in right eye, and urinary retention. On day eight since admission, patient had acute worsening blurred vision in left eye (blurry vision of right eye never improved) during her rehab stay and was transferred to another facility for plasmapheresis on day nine from admission. Plasma exchange was planned for five treatments for acute disseminated encephalomyelitis (ADEM), patient started noticing improvement in visual and urinary symptoms. She was discharged on steroid taper with advice to follow up with ophthalmology, urology, and neurology as outpatient. Urinary retention completely resolved, per neuro-ophthalmology, patient likely had optic neuritis which resolved to optic atrophy. Author discussed a case of ADEM following COVID mRNA vaccine administration and mycoplasma detection. ADEM should be considered in the differential diagnosis of any case presented with a suggestive clinical picture after COVID vaccine administration. Moreover, careful immunization history is necessary in any case presented with ADEM. More studies are needed to identify if there is a relation between COVID vaccination and ADEM. Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2022: Case was unlocked on 27-Nov-2025 as a part of Health Inspection to perform significant correction to update report type as Literature Non-study, case validity from invalid to valid, literature information, added lab data, event and narrative updated.; Reporter's Comments: Mycoplasma infection remains as a confounding factor. The benefit-risk relationship of product is not affected by this report.
Anxiety; Hyperlipidemia; Hypothyroidism
Medical History/Concurrent Conditions: Renal stone
Levothyroxine
Test Name: Albumin, CSF; Test Result: 59 mg/dL; Test Name: ACE, CSF; Result Unstructured Data: 6 p/mol/L/min; Test Name: IgA, CSF; Test Result: 1.8 mg/dL; Test Name: IgG, CSF; Test Result: 11.6 mg/dL; Test Name: IgM, CSF; Test Result: 1.8 mg/dL; Test Name: Serum K; Test Name: CT head without contrast; Result Unstructured Data: Showed a 2.4 cm low-density mass in anterior left frontal lobe along with multiple supratentorial and infratentorial lesions consistent with demyelinating disease either multiple sclerosis (MS) or acute disseminated encephalomyelitis (ADEM); Test Name: Cryptococcus antigen, CSF; Test Result: Negative ; Test Name: Glucose, CSF; Test Result: 66 mg/dL; Test Name: Myelin basic protein, CSF; Test Name: Protein, CSF; Test Result: 98 mg/dL; Test Name: RBC, CSF; Test Name: WBC, CSF; Test Name: CMV IgM Ab; Result Unstructured Data: less than 30 mg/dL; Test Name: CMV qPCR; Test Result: Negative ; Test Name: EBV DNA qPCR; Test Name: HSV 1; Test Result: Negative ; Test Name: HIV; Result Unstructured Data: Non-reactive; Test Name: Flu A; Test Result: Negative ; Test Name: Flu B; Test Result: Negative ; Test Name: T2 MRI brain with and without contrast; Result Unstructured Data: showed multifocal supratentorial predominantly periventricular lesions with a single lesion in right upper cervical cord and an enhancing 17 mm lesion in left frontal white matter with surrounding edema, again findings consistent with demyelinating disease, showed an enhancing 17.3 mm lesion in the left frontal white matter with surrounding edema; Test Name: T2 MRI brain with and without contrast; Result Unstructured Data: Showed improvement, previous lesions seemed to decrease in size or resolved (After 14 days); Test Name: T2 MRI brain with and without contrast; Result Unstructured Data: Showed resolution of previously reported demyelinating lesions and no new demyelinating lesions (Six months later); Test Name: Cervical and thoracic spine with and without contrast; Result Unstructured Data: Shows diffuse abnormal central cord signal intensity throughout thoracic spine, extending into cervical cord and conus with focal enhancement in left central region at T7-T8 level. Multifocal and diffuse abnormal central cord signal intensity beginning at C3-C4 extending into thoracic spine with focal sparing at C5-C6. Diffuse abnormal central cord signal intensity throughout thoracic spine was favoring ADEM considering recent MRI brain findings; Test Name: Cervical and thoracic spine with and without contrast; Result Unstructured Data: Showed improvement, previous lesions seemed to decrease in size or resolved (After 14 days); Test Name: Cervical and thoracic spine with and without contrast; Result Unstructured Data: Showed resolution of previously reported demyelinating lesions and no new demyelinating lesions (Six months later); Test Name: T2 MRI lumbar spine with and without contrast; Result Unstructured Data: T2 MRI lumbar spine with and without contrast showed a 12 mm lesion in conus at T11-12 level consistent with an active demyelinating plaque; Test Name: Mycoplasma pneumonia Ab, IgG; Test Result: 4.07 mg/dL; Test Name: Mycoplasma pneumonia Ab, IgM; Test Result: 1943 mg/dL; Test Name: Mycoplasma pneumonia IgG; Test Result: Positive ; Test Name: Mycoplasma pneumonia IgM; Test Result: Positive ; Test Name: Oligoclonal bands, CSF; Result Unstructured Data: No bands; Test Name: Ophthalmological evaluation; Result Unstructured Data: Repeatedly found sable; Test Name: Physical examination; Result Unstructured Data: showed muscle strength 1/5, 0 deep tendon reflexes of bilateral lower extremities, bilateral and equal diminished sensation to touch and pinprick, and sensory level at T3. Gait couldn't be checked since she wasn't able to stand, rest of the physical examination was otherwise normal; Test Name: COVID-19 IgG; Test Result: 0.09 mg/dL; Test Name: coronavirus disease 2019 (COVID-19) by polymerase chain reaction (PCR)-RNA test; Test Result: Negative ; Test Name: venereal disease research laboratory/rapid plasma reagin; Result Unstructured Data: Non-reactive; Test Name: venereal disease research laboratory/rapid plasma reagin, CSF (VDRL/RPR, CSF); Result Unstructured Data: Non-reactive in CSF; Test Name: VZV DNA, CSF; Result Unstructured Data: Not detected; Test Name: Visual field test; Result Unstructured Data: Visual field test showed blind spot, ceco-central scotoma in both eyes; Test Name: vital signs; Result Unstructured Data: On arrival vital signs were stable; Test Name: West Nile Ab IgG/West Nile Ab IgM, CSF; Result Unstructured Data: West Nile Ab IgG, CSF- less than 1.30; Test Name: West Nile Ab IgG/West Nile Ab IgM, CSF; Result Unstructured Data: West Nile Ab IgM, CSF- less than 0.90; Test Name: Mild leucocytosis; Result Unstructured Data: 12.1 x1,000/mL Mild leucocytosis