Adverse Event Reporting
| VAERS ID | 1972287 |
|---|---|
| Gender | Female |
| Age | 16 |
| StateCode | FR |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | |
| Number of vaccinations | 2 |
| Vaccinated | 2018-03-21 |
| Onset | 2021-03-31 |
| Condition | Hospitalized Permanent Disability |
Symptoms
- Fatigue
- Headache
- Dizziness
- Paraesthesia
- Balance disorder
- Multiple sclerosis
- Quadriparesis
Current Illness
Preexisting Conditions
Medical History/Concurrent Conditions: Abstains from alcohol; Juvenile idiopathic arthritis; Non-tobacco user; Urticaria heat (Allergy)
Other Medications
ARAVA
Previous Vaccinations
Allergies
Laboratory Data
Write-up
multiple sclerosis; rapidly ascending tetraparesis; Tingling paresthesias on fingers/Tingling paresthesias on toes; severe headaches; considerable fatigue for 3-4 days; dizziness; balance disorders, which also lasted 3-4 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority.
Regulatory number: CH-SM-2021-28437.
A 16 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Mar2021 (Batch/Lot number: unknown) at the age of 16 years as dose 2, single for covid-19 immunisation; infliximab (INFLECTRA), from 21Mar2018 (Batch/Lot number: unknown) to 31Mar2021 at 250 mg cyclic (every 6 weeks, cyclic) for juvenile idiopathic arthritis.
Relevant medical history included: "Juvenile idiopathic arthritis" (unspecified if ongoing); "Heat-induced urticaria" (unspecified if ongoing), notes: Allergy; "No Tobacco" (unspecified if ongoing); "Abstains from alcohol" (unspecified if ongoing).
Concomitant medication(s) included: ARAVA taken for juvenile idiopathic arthritis, start date: 15Jun2017.
Past drug history included: Inflectra, start date: 21Mar2018, for Juvenile rheumatoid arthritis, reaction(s): "headache aggravated"; Inflectra, start date: 21Mar2018, for Juvenile rheumatoid arthritis, reaction(s): "fatigue".
Vaccination history included: Comirnaty (1st dose, batch/lot: EL8723), administration date: 18Feb2021, for COVID-19 immunisation, reaction(s): "headache aggravated", "fatigue".
The following information was reported: QUADRIPARESIS (hospitalization, disability, medically significant) with onset 01Apr2021, outcome "recovered", described as "rapidly ascending tetraparesis"; PARAESTHESIA (hospitalization, medically significant) with onset 31Mar2021, outcome "not recovered", described as "Tingling paresthesias on fingers/Tingling paresthesias on toes"; MULTIPLE SCLEROSIS (hospitalization, medically significant) with onset 01Apr2021, outcome "unknown", described as "multiple sclerosis"; HEADACHE (non-serious), outcome "unknown", described as "severe headaches"; FATIGUE (non-serious), outcome "unknown", described as "considerable fatigue for 3-4 days"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness"; BALANCE DISORDER (non-serious), outcome "unknown", described as "balance disorders, which also lasted 3-4 days".
The action taken for infliximab was dosage permanently withdrawn on 31Mar2021.
Therapeutic measures were taken as a result of quadriparesis, paraesthesia, paraesthesia and included treatment with Privigen (human immunoglobulin).
Clinical Course: Initially, GBS (Guillain-Barre syndrome) was postulated, but this was discarded in the course.
Therapy with Privigen (human immunoglobulin) was initiated.
During neuro-rehabilitation following the acute hospitalization, the ability to move arms and legs returned after about 6 weeks.
However, no sensation in arms and legs continued until the reporting date.
In Sep2021, multiple sclerosis was diagnosed and infliximab was suspected to trigger the initial manifestation on 01Apr2021.
Starting in November, the patient is planned to be treated with Ocrevus (ocrelizumab), as treatment with Inflectra (infliximab) was permanently discontinued after 01Apr2021.
There is a temporal relationship between the use of Comirnaty (tozinameran) and the occurrence of paresthesias in fingers and toes and tetraparesis.
Similarly, there is a temporal relationship between the use of Inflectra (infliximab) and the onset of symptoms.
Although some symptoms are also documented for Arava (leflunomide) in the drug information, since the patient had only received Comirnaty (tozinameran), Arava (leflunomide) seems etiologically less likely as the cause of the paresthesia's and tetraparesis.
The partial improvement of symptoms during the course represents a partial positive dechallenge.
In summary, based on the temporal relationship, the documentation in the drug information as well as in the databases, but possible other non-drug causes that cannot be excluded, we formally assess the causality between the use of Comirnaty (tozinameran) and Inflectra (infliximab) and the occurrence of the tingling paresthesias in fingers and toes as well as the rapidly progressive tetraparesis according to RA criteria as possible for each preparation individually and overall.
Causality assessment: A causal relationship between Comirnaty, Inflectra and AEs: Paresthesia of fingers, Paresthesia foot, Tetraparesis was assessed as being possible Seriousness: This case was reported as serious (hospitalized, medically significant) No follow-up attempts are possible; information about lot/batch number cannot be obtained.
No further information is expected.
; Sender's Comments: Linked Report(s) : CH-PFIZER INC-202101820660 Same patient, different events, first dose.