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VAERS Report 2157076

Case Report Section

Vaer Report Details

Age: 25 years old

Gender: Unknown

State: Outside US

Patient Died?
No
Vaccine information

Name: DT ADSORBED (NO BRAND NAME)

Type: Diphtheria and tetanus toxoids, pediatric

Manufacturer: UNKNOWN

Lot: unknown


Name: VACCINE NOT SPECIFIED (NO BRAND NAME)

Type: Unknown vaccine type

Manufacturer: UNKNOWN

Lot: unknown


Date report was received
2022-03-04
Date form completed
Date Vaccinated
2021-03-08
Date of Onset
9
Number of days (onset date – vaccination date)
9
Adverse Event Description

low grade fever; blurred vision; retrobulbar pain; abdominal numbness; retention of urine; other demyelinating diseases of central nervous system; lumbago; muscle weakness of lower extremities; numbness of lower extremities; encephalitis, myelitis and encephalomyelitis, unspecified; urination difficulty; initial information regarding this unsolicited valid serious case downloaded from regulatory authority, was received on 23-feb-2022 from consumer/non-hcp via health authorities under reference gr-greof-202200787. the following narrative is based on the information retrieved from all other accessible data this case involves a 25 years old and unknown gender patient who had lumbago, muscle weakness of lower extremities, low grade fever, numbness of lower extremities, retrobulbar pain, blurred vision, retention of urine, encephalitis, myelitis and encephalomyelitis, unspecified, abdominal numbness, other demyelinating diseases of central nervous system and urination difficulty while receiving vaccines diphtheria and tetanus toxoids and nimenrix. the patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. on 08-mar-2021, the patient received a dose of suspect diphtheria and tetanus toxoids produced by unknown manufacturer with unknown formulation, strength, batch number, expiry date via unknown route in unknown administration site to prevent infections of diphtheria, tetanus. on 08-mar-2021, the patient received a dose of suspect nimenrix not produced by sanofi pasteur with unknown strength, route, formulation, cyclical, batch umber, number, expiry date via unknown route in unknown administration site for meningococcal immunization. on an unknown date the patient developed low grade fever (pyrexia), myelitis and encephalomyelitis, unspecified (myelitis) with unspecified latency following the administration of nimenrix and diphtheria and tetanus toxoids. on 17-mar-2021 the patient developed lumbago (back pain), muscle weakness of lower extremities (muscular weakness), numbness of lower extremities (hypoaesthesia) 9 days following the administration of diphtheria and tetanus toxoids and nimenrix. on 18-mar-2021 the patient developed other demyelinating diseases of central nervous system (demyelination) 10 days following the administration of nimenrix and diphtheria and tetanus toxoids. on 19-mar-2021 the patient developed urination difficulty (dysuria) 11 days following the administration of nimenrix and diphtheria and tetanus toxoids. on 20-mar-2021 the patient developed retention of urine (urinary retention), abdominal numbness (hypoaesthesia) 12 days following the administration of diphtheria and tetanus toxoids and nimenrix. relevant laboratory test results included: on 20-mar-2021 computerised tomogram(ct) of lumbar spine and ct brain scan was normal. on 22-mar-2021 magnetic resonance imaging of brain and cervical spine, thoracic spine was abnormal and showed myelopathy (possible transverse myelitis). on 07-apr-2021 the patient developed retrobulbar pain (eye pain) 1 month following the administration of nimenrix and diphtheria and tetanus toxoids. on 12-apr-2021 the patient developed blurred vision (vision blurred) 1 month 4 days following the administration of diphtheria and tetanus toxoids and nimenrix. on an unknown date patient was tested negative for sars-cov-2 test. action taken with meningococcal vaccine a/c/y/w conj (tet tox) (nimenrix) and diphtheria and tetanus toxoids was not applicable. it was not reported if the patient received a corrective treatment for the events (myelitis, pyrexia, back pain, muscular weakness, hypoaesthesia, demyelination, dysuria, urinary retention, eye pain, vision blurred). at time of reporting, the outcome was unknown for the events lumbago, muscle weakness of lower extremities, low grade fever, urination difficulty, numbness of lower extremities, retrobulbar pain, blurred vision, retention of urine, encephalitis, myelitis and encephalomyelitis, unspecified, abdominal numbness and was not recovered / not resolved for the event other demyelinating diseases of central nervous system. seriousness criteria: the events vision blurred, urinary retention, myelitis were assessed as medically significant along with causing hospitalization. the event demyelination was assessed as medically significant and was leading to disability and hospitalization. the events back pain, pyrexia, hypoaesthesia, eye pain, muscular weakness were assessed caused hospitalization.; sender's comments: sanofi company comment dated 28-feb-2022: this case involves 25 years old unknown gender patient who had myelitis, pyrexia, back pain, muscular weakness, hypoaesthesia, demyelination, dysuria, urinary retention, eye pain, vision blurred while receiving the vaccines nimenrix and diphtheria and tetanus toxoids. the role of non company suspect in causing the adverse events cannot be ruled out. based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history and concomitant medications

Lab Data
test date: 20210320; test name: ct scan; result unstructured data: normal: no abnormal findings; comments: lumbar spine ct scan; test date: 20210320; test name: ct brain scan; result unstructured data: normal; test date: 20210322; test name: mri abnormal; result unstructured data: abnormal: myelopathy (possible transverse myelitis); comments: mri of cervical spine and of thoracic spine.; test date: 20210322; test name: mri brain abnormal; result unstructured data: myelopathy; test name: sars-cov-2 infection; result unstructured data: negative; comments: 2 tests performed in total
List of symptoms
myelitis sars-cov-2 test negative back pain eye pain vision blurred encephalitis urinary retention demyelination pyrexia dysuria hypoaesthesia muscular weakness computerised tomogram normal computerised tomogram head normal encephalomyelitis magnetic resonance imaging spinal abnormal magnetic resonance imaging head abnormal
Patient Died?
No
Date Died
NA
Birth defect
false
Vaccine Administered By:
Other
Vaccine Purchased By:
Unknown
Patient visit ER?
No
Patient Hospitalized?
Yes
Stay in hospital
No
Days in hospital
Unspecified
Permanent disability?
Yes
Allergies:
na
Current Illness
na