Adverse Event Reporting
| VAERS ID | 2484741 |
|---|---|
| Gender | Male |
| Age | 65 |
| StateCode | FR |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | FP1972 |
| Number of vaccinations | 4 |
| Vaccinated | 2022-08-01 |
| Onset | 2022-08-01 |
| Condition | Hospitalized Permanent Disability |
Symptoms
- Facial paresis
- Immunisation
- Off label use
Current Illness
Type 2 diabetes mellitus
Preexisting Conditions
Other Medications
AMILOFERM; MITFORGEN
Previous Vaccinations
Allergies
Laboratory Data
Write-up
facial paresis/hanging and crooked mouth; Booster; Off label use; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician) from the regulatory authority-WEB.
Other Case identifier(s): SE-MPA-2022-019334 (RA), SE-VISMA-1664188889687 (RA).
A 65-year-old male patient received BNT162b2 (COMIRNATY), on 01Aug2022 as dose 4 (booster), single (Lot number: FP1972) at the age of 65 years for covid-19 immunisation.
The patient's relevant medical history included: "Type 2 diabetes mellitus" (ongoing).
Concomitant medication(s) included: AMILOFERM oral; MITFORGEN oral.
Vaccination history included: comirnaty (Dose 1, Single), administration date: 22Apr2021, for covid-19 immunization; comirnaty (Dose 2, Single), administration date: 03Jun2021, for covid-19 immunization, reaction(s): "Inappropriate schedule of product administration"; comirnaty (Dose 3 (booster), Single), administration date: 19Nov2021, for covid-19 immunization.
The following information was reported: IMMUNISATION (hospitalization, disability) with onset 01Aug2022, outcome "unknown", described as "Booster"; OFF LABEL USE (hospitalization, disability) with onset 01Aug2022, outcome "unknown"; FACIAL PARESIS (hospitalization, disability) with onset 20Aug2022, outcome "recovering", described as "facial paresis/hanging and crooked mouth".
Clinical course: Reporter is a contactable insurance company (non-hcp) dealing with product complaints.
On 13Oct2022, According to the description, the man suffered from a hanging and crooked mouth, which made it difficult to eat and drink.
Furthermore, it is stated that the eye had no blink reflex and was watery.
No further information appears in the report.
Reported suspected side effect is facial paralysis with onset of symptoms 19 days after the vaccination.
According to the description, the man was hit of drooping and crooked mouth, which made it difficult to eat and drink.
Furthermore, it is stated that the eye was missing blink reflex and was running.
No further information appears from the report.
Follow-up report received from a hospital doctor.
The previously reported suspect the side effect facial paralysis has medical confirmed.
The reporting physician states that investigation has ruled out an infectious cause.
The case assessed as serious, hospitalization, permanent disability.
Concomitant medication with Mitforgen and Amiloferm.
No follow-up attempts are possible.
No further information is expected.
Follow-up (13Oct2022): This is a follow up report combining information from duplicate reports #PV202200073532 and #202201210550.
The current and all subsequent follow-up information will be reported under manufacturer report number #PV202200073532.
New information reported from the non-retained case included: Updated information included: New reporter was added in slide#2; Patient details (height and weight); RMH and Vaccination history was updated; Dose details was updated (dose number, dose description and lot number); New concomitant drugs was added (Mitforgen and Amiloferm); Event Facial paresis verbatim, outcome and seriousness criteria was added hospitalization and disability; Added new events Off label use and booster; Off label use checked in product tab; Clinical course and narrative was updated with case closure line; Additional information tab was updated.
No follow-up attempts are possible.
No further information is expected.
; Sender's Comments: Linked Report(s) : SE-PFIZER INC-202201219011 Same patient and product.
Different events and doses;