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VAERS ID: 1000340

AGE: UNK| SEX: F|State: FR

Description

Dysuria; Hyperreflexia; Extensor plantar response; Anal sphincter atony; Urinary retention; Myelitis transverse; Paraesthesia; This is a spontaneous report from a contactable physician from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202101191454133610 with Safety Report Unique Identifier GB-MHRA-ADR 24615906. A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EEG993), via an unspecified route of administration from on 11Jan2021 at a single dose for COVID-19 immunisation. Medical history included suspected covid-19: unsure when symptoms started and stopped and was Covid-19 virus test "Yes - Positive COVID-19 test" on an unspecified date; and spinal osteoarthritis. The patient is usually fit and well; not pregnant and is not enrolled in clinical trial. Concomitant medications were not reported. On 14Jan2021, the patient experienced myelitis transverse and paraesthesia. On an unspecified date, the patient experienced dysuria, hyperreflexia, extensor plantar response, anal sphincter atony and urinary retention. The events were described as: 3 days after administration of vaccine noted paraesthesia to feet and legs. This subsequently rose to her hips. She has also noted difficulty in passing urine. Admitted to hospital 7 days following vaccination (18Jan2021). At this time, she had paraesthesia up to the level of her hips, brisk lower limb tendon reflexes and upgoing plantars. Power normal. She has reduced anal tone as well as significant post void residual on bladder scan. She has been reviewed by one of the consultant neurologists who has clinically diagnosed transverse myelitis and commenced treatment with intravenous steroids. Patient has not tested positive for COVID-19 since having the vaccine. MRI Spine showed degenerative cervical spine disease but no other changes. The regulatory authority assessed the events as serious requiring hospitalization and medically significant. The patient has not recovered from myelitis transverse. The outcome of the remaining events was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported serious events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Symptoms

Anal sphincter atony, Magnetic resonance imaging, Bladder scan, Myelitis transverse, Dysuria, Paraesthesia, Extensor plantar response, SARS-CoV-2 test, Hyperreflexia, Urinary retention

Vaccines

VAX DATE: 10 January 2021 | ONSET DATE: 13 January 2021 | DAYS TO ONSET: 3
Vaccine TypeManufacturerVaccine NameDoseRouteSiteLot
  • COVID19
  • PFIZERBIONTECH
  • COVID19 (COVID19 (PFIZER-BIONTECH))
  • UNK
  • EEG993

RECVDATE:
03 February 2021
CAGE_YR:
CAGE_MO:
RPT_DATE:
DIED:
DATEDIED:
L_THREAT:
ER_VISIT:
HOSPITAL:
Y
HOSPDAYS:
X_STAY:
DISABLE:
RECOVD:
N
LAB_DATA:
Test Name: Bladder scan; Result Unstructured Data: Test Result:significant post void residual; Test Name: MRI; Result Unstructured Data: Test Result:degenerative cervical spine disease; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
V_ADMINBY:
OTH
OTHER_MEDS:
CUR_ILL:
HISTORY:
Medical History/Concurrent Conditions: Cervical spine degeneration; Suspected COVID-19 (Unsure when symptoms startedUnsure when symptoms stopped)
PRIOR_VAX:
SPLTTYPE:
GBPFIZER INC2021052070
FORM_VERS:
2
TODAYS_DATE:
02 February 2021
BIRTH_DEFECT:
OFC_VISIT:
ER_ED_VISIT:
ALLERGIES:
V_FUNDBY:
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