Adverse Event Reporting
| VAERS ID | 1391099 |
|---|---|
| Gender | Unknown |
| Age | |
| StateCode | CA |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | EN6201 |
| Number of vaccinations | 1 |
| Vaccinated | 2021-02-26 |
| Onset | 2021-02-26 |
| Condition | Permanent Disability |
Symptoms
- Fatigue
- Pain in extremity
- Pain
- Hypersensitivity
- Vision blurred
- Hypotonia
- Bell's palsy
Current Illness
Preexisting Conditions
Medical History/Concurrent Conditions: Tremor of hands (she take's Topamax)
Other Medications
TOPAMAX
Previous Vaccinations
Allergies
Laboratory Data
Write-up
Her vision is blurry she went to the eye doctor and in the back of the right eye there are two blisters that are representing an allergic reaction; fatigued; Severe pain/The pain is terrible it is ongoing.
Her right forehead temporal all the way down the jaw line to her right ear; Blurry vision; right side of her face was flaccid; That day they diagnosed four other patients with Bell's Palsy who received Pfizer.
; Sore arm; This is a spontaneous report from a contactable other hcp.
A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6201), via an unspecified route of administration, administered in arm right on 26Feb2021 at a 1st dose, single dose and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6199) via an unspecified route of administration, administered in arm right on 19Mar2021 at 2nd dose, single dose, both the doses for covid-19 immunisation.
Medical history included tremor (she take's Topamax because she has a very fine essential hand tremor so they wanted to try that in her right hand).
Concomitant medication included topiramate (TOPAMAX) taken for tremor.
Prior Vaccinations within 4 weeks was no, adverse event following prior vaccinations was none she has had the flu vaccine and shingles no reaction.
The patient did not had additional vaccines administered on same date of the pfizer suspect.
On an unknown date, the patient experienced fatigued, Her vision is blurry she went to the eye doctor and in the back of the right eye there are two blisters that are representing an allergic reaction, on 26Feb2021 the patient experienced Sore arm, on 04May2021, the patient experienced That day they diagnosed four other patients with Bell's Palsy who received Pfizer, right side of her face was flaccid, on 06May2021, the patient experienced Blurry vision, on 10May2021 Severe pain/The pain is terrible it is ongoing.
Her right forehead temporal all the way down the jaw line to her right ear.
All the adverse events lead to emergency room visit.
Patient received treatment as eye drops for the event Her vision is blurry she went to the eye doctor and in the back of the right eye there are two blisters that are representing an allergic reaction and prednisone 60 mg a day for a week.
And the other one was acyclovir an anti-viral 1 gram 3 times a day for a week as a treatment for the event that day they diagnosed four other patients with Bell's Palsy who received Pfizer, right side of her face was flaccid.
Event Details: Patient talked to Pfizer.
Patient had to gone to ER on 06May2021.
She woke up actually on the 04May2021.
She looked in mirror and the right side of her face was flaccid and muscles weren't moving and she said her lips were numb.
Right side of her face was flaccid: Attempted to clarify seriousness criteria with patient.
Patient stated it was disfiguring initially then said it was disabling.
Patient stated it was a slight improvement.
Treatment - When she got this patient called an MD live where you talk to a doctor.
Patient wanted to know if it was one of her medications that could cause this.
He said she take's Topamax because she has a very fine essential hand tremor so they wanted to try that in her right hand.
He said that if it was that medication they would stop it and in a few days it would go away and it persisted and her eye closed.
Muscles weren't moving: treatment - On 06May2021 patient went to the ER.
Patient had her friend take her there.
Two ER doctors saw it and they said it Bell's palsy.
Patient has some other symptoms that have occurred about 2.
5 to 3 weeks ago with the right side of your face she had severe pain.
Severe pain: The pain is terrible it is ongoing.
Her right forehead temporal all the way down the jaw line to her right ear.
It is disabling you can't imagine.
Why did she get this.
The pain is still persisting day and night.
Treatment - Her primary doc-tor ordered physical therapy she hasn't started treatment.
Its not until 08Jun2021 she guesses they are going to do ultrasound she will get an evaluation with the ultrasound to see if they can reduce the inflammation to all those areas where her face isn't moving, the muscle.
She thinks it is important to add that coffee or any liquids drips out of her mouth and onto her top.
She has to bend over the kitchen table she can't chew her food on the right side and the food goes up to the gum line and doesn't go anywhere.
The inside of her cheek muscles aren't moving.
Causality: She was fine.
Yes, patient was healthy she would walk visit her friends with the covid thing patient hasn't been visiting that much just on the phone talking or going grocery store.
Patient wasn't sick with the cold or flu, nothing.
She wasn't stressed.
Time the Vaccination Was Given: Her vision is blurry she went to the eye doctor and in the back of the right eye there are two blisters that are representing an allergic reaction.
Blurry vision: It is ongoing she can't even look at phone.
Patient has to get the non prescriptive reading glasses.
He said she didn't need eye glasses.
Treatment - He said to put in eye drops, prescriptive, now they sell it over the counter for allergic reaction to eye.
One drop in both eyes.
It is persisting patient has never had vision problems before all of this.
Adverse event require a visit to Emergency Room, on 06May2021 she went to the ER and they had two ER doctors verify that it was Bell's Palsy.
Just a tid bit the ER doctor said we never had so many Bell's Palsy patients.
That day they diagnosed four other patients with Bell's Palsy who received Pfizer.
DSU agent asked caller if she had any further information on the patients or would like to file a safety report on their behalf.
Reporter declined to provide any further information and declined to complete a safety report on their behalf stating no that would be against HIPPA.
Sore arm: start - The day she got her first injection on 26Feb2021.
Then it went away she would say 48 hours.
The second vaccine her arm was sore like the first one and she felt fatigued for about 72 hours but then it went away.
The CDC had told her on the phone that 10% of people either get neurological or Bell's Palsy from the Pfizer vaccine.
The pain is severe and just so unbearable.
They are going to do an MRI to see if the virus is still occurring to the 7th cranial never.
The event that day they diagnosed four other patients with Bell's Palsy who received Pfizer was considered as serious with seriousness disability, medically significant, the events Blurry vision, right side of her face was flaccid, Severe pain/The pain is terrible it is ongoing.
Her right forehead temporal all the way down the jaw line to her right ear was considered as serious with seriousness disability.
Out-come of the events severe pain/the pain is terrible it is ongoing.
her right forehead temporal all the way down the jaw line to her right ear, her vision is blurry she went to the eye doctor and in the back of the right eye there are two blisters that are representing an allergic reaction was not re-solved and that day they diagnosed four other patients with Bell's Palsy who received Pfizer, Blurry vision, right side of her face was flaccid, fatigued, Sore arm was unknown.
Causality as per reporter was related to the events Severe pain, Sore arm, fatigued, right side of her face was flaccid, the patient experienced That day they diagnosed four other patients with Bell's Palsy who received Pfizer, right side of her face was flaccid.
PSCC Communication: DSU agent attempted to clarify with caller if she had any medically related questions that we suggest she reaches out to her primary care provider.
Provided caller with Report Reference PSBNIJOC.
Information on Lot/Batch number has been requested.
; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of bell'spalsy,hypersensitivity,hypotonia,blurred vision,hypotonia,pain cannot be excluded But also consider concomitant medications and relevant medical history.
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,Linked Report(s) : US-PFIZER INC-2021662288 same reporter/product/event, different patient;US-PFIZER INC-2021662287 same reporter/product/event, different patient;US-PFIZER INC-2021662286 same reporter/product/event, different patient