Adverse Event Reporting
| VAERS ID | 1265870 |
|---|---|
| Gender | Male |
| Age | |
| StateCode | CA |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | |
| Number of vaccinations | |
| Vaccinated | |
| Onset | 2020-08-01 |
| Condition | Permanent Disability |
Symptoms
- Injection site erythema
- Somnolence
- Gait disturbance
- Neuropathy peripheral
- Abnormal dreams
- Weight increased
- Drug ineffective
- Cataract
- Monoclonal gammopathy
Current Illness
Preexisting Conditions
Medical History/Concurrent Conditions: Appendectomy; Cataract operation; Drug allergy (sulfa); Pre-diabetic; Proctectomy; Sinus operation
Other Medications
EDEMIDE; BEMPEDOIC ACID
Previous Vaccinations
Allergies
Laboratory Data
Write-up
The consumer reported he is on Eliquis for DVT behind his right knee that is still there; cataract surgery; neuropathy; He has gained five pounds; The first shot he took, his arm turned red; wanted to sleep a lot; weird dreams; He has been on the walker for 8 months now; Monoclonal gammopathy; This is a spontaneous report from a contactable consumer, based on information received by Pfizer (manufacturer control number:COMPANY-BMS-2021-037416), license party for apixaban (ELIQUIS).
This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (neuropathy), CATARACT (cataract surgery) and GAIT DISTURBANCE (He has been on the walker for 8 months now) in 80-year-old male patient who received apixaban (Eliquis) tablet (batch no.
1708750) for DVT.
The occurrence of additional non-serious events is detailed below CO-SUSPECT PRODUCTS included Covid-19 Vaccine for an unknown indication.
Product or product use issues identified: DRUG INEFFECTIVE (The consumer reported he is on Eliquis for DVT behind his right knee that is still there) (seriousness criterion medically significant).
The patient's past medical history included Pre-diabetic, Proctectomy, Sinus operation, Appendectomy and Drug allergy (sulfa).
In 2018, the patient started Eliquis (batch no.
1708750) (Oral), 5 milligram twice a day.
On an unknown date, the patient started Covid-19 Vaccine (unknown route).
In 2020, the patient experienced MONOCLONAL GAMMOPATHY.
In August 2020, the patient experienced GAIT DISTURBANCE (seriousness criterion disability).
On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (seriousness criterion medically significant), CATARACT (seriousness criterion medically significant), WEIGHT INCREASED (He has gained five pounds), INJECTION SITE ERYTHEMA (The first shot he took, his arm turned red), SOMNOLENCE (wanted to sleep a lot) and ABNORMAL DREAMS (weird dreams).
The patient was treated with Surgery (cataract surgery) for Cataract.
The action taken with Eliquis(Oral) was unknown.
At the time of the report, NEUROPATHY PERIPHERAL, CATARACT, GAIT DISTURBANCE, MONOCLONAL GAMMOPATHY, WEIGHT INCREASED, INJECTION SITE ERYTHEMA, SOMNOLENCE and ABNORMAL DREAMS outcome was unknown.
The patient received apixaban at a strength of 5 mg.
The consumer reported he was on apixaban, 5 mg twice daily by mouth for a DVT behind his right knee that was still there.
He started the medication three years ago.
He stated he had to get his glasses.
He had cataract surgery three or four years ago.
He has neuropathy and believed it was affecting his right eye.
He has had the neuropathy for quite a while.
He finally went to neurologist and figured out he has neuropathy.
The neurologist did needles.
The neurologist found he also has MGUS (Monoclonal gammopathy).
He stated it was a protein that was formed in the bone marrow and goes into the blood stream.
He stated he has had it for a while.
It was over a year ago when he found he had it.
He stated the neurologist gives the test to people over 70 years old.
The neurologist said it was idiopathic or pre-diabetic that caused it.
He has gained five pounds.
He stated he has to get off the chocolate.
He was walking every day.
The patient uses a walker which he stated was driving him nuts.
He has been on the walker for 8 months now (Aug-2020).
He reported he had his COVID shot and would not go through it again.
The first shot he took, his arm turned red and it bothered his thinking.
He put something down and misplaced it.
After the second shot, he felt really bad and wanted to sleep a lot.
He did not feel like doing anything.
That lasted for a day.
It came back a week later.
He stated he has been busy and working on taxes.
He reported he had weird dreams right after having it.
For Eliquis(Oral), the reporter considered NEUROPATHY PERIPHERAL to be not related.
No further causality assessments were provided for CATARACT, GAIT DISTURBANCE, MONOCLONAL GAMMOPATHY, WEIGHT INCREASED, INJECTION SITE ERYTHEMA, SOMNOLENCE and ABNORMAL DREAMS.
Case Assessment Drug: ELIQUIS Injection site redness, Sleepiness, Abnormal dreams, Monoclonal gammopathy, Drug ineffective, Cataract, Weight gain,Walking difficulty Per Reporter= Not related Per Company =Related Drug: ELIQUIS Neuropathy Per Reporter= Not Related Per Company = Not Related; Sender's Comments:Medical Evaluation Comment: This 80 -year-old patient had multiple events after receiving apixaban therapy.
This patient also got vaccinated for COVID-19.
Elderly age with medical history of pre-diabetes are likely the risk factors for the reported events peripheral neuropathy, cataract and gait disturbance; hence considered as not related to apixaban.
Drug ineffective is inherent to the nature of pharmacotherapy and is considered not related to the suspect.