Adverse Event Reporting
| VAERS ID | 984616 |
|---|---|
| Gender | Female |
| Age | 78 |
| StateCode | MT |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | |
| Number of vaccinations | 1 |
| Vaccinated | 2021-01-16 |
| Onset | 2021-01-16 |
| Condition | Hospitalized Life Threatening Permanent Disability |
Symptoms
- Fatigue
- Pyrexia
- Headache
- Dyspnoea
- Nausea
- Asthenia
- Heart rate increased
- Respiratory rate increased
- SARS-CoV-2 test negative
- Electrocardiogram abnormal
- Angiogram
- Hypopnoea
- X-ray abnormal
- Pleural effusion
- Angiogram abnormal
- Pericardial effusion
Current Illness
Preexisting Conditions
Medical History/Concurrent Conditions: Cirrhosis liver; Dementia; Depression; Drug allergy; Fish allergy; Heart block; Parkinsonism; Portal hypertension; Type 2 diabetes mellitus
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Test Date: 20210116; Test Name: CTA; Result Unstructured Data: Test Result:had a pleuralpericardial effusion; Test Date: 20210116; Test Name: body temperature; Result Unstructured Data: Test Result:low grade fever; Test Date: 20210116; Test Name: EKG; Result Unstructured Data: Test Result:had a pleuralpericardial effusion; Test Date: 20210116; Test Name: heart rate; Result Unstructured Data: Test Result:100 bpm; Test Date: 20210117; Test Name: Rapid Nasal Swab; Test Result: Negative ; Test Date: 20210116; Test Name: Xray; Result Unstructured Data: Test Result:had a pleuralpericardial effusion
Write-up
felt tired; nausea; headache; short of breath; rapid/shallow breathing; rapid/shallow breathing; fast heart rate (100 bpm); low grade fever; felt very weak; pleuralpericardial effusion; pleuralpericardial effusion; This is a spontaneous report from a contactable consumer.
A non-pregnant 78-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm on 16Jan2021 10:30 at a single dose for COVID-19 immunization.
Medical history included allergic to opioids, allergy to fish, cirrhosis with portal hypertension, parkinsonism, heart blockage, type 2 diabetes, depression, early dementia.
The patient previously took morphine and experienced drug hypersensitivity.
There was unspecified concomitant medication.
The patient previously took morphine (MANUFACTURER UNKNOWN) and experienced allergic to morphine.
The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
The patient experienced felt tired, nausea, headache, short of breath, rapid/shallow breathing, fast heart rate (100 bpm), low grade fever, felt very weak, pleuralpericardial effusion on 16Jan2021.
All the events were reported with the seriousness criteria of disability, hospitalization and being life-threatening.
The patient was hospitalized for the events for 4 days.
After the injection, from 0 to 24 hours the patient felt tired, had nausea, a headache, short of breath then at about 24 hours post injection developed rapid/shallow breathing, fast heart rate (100 bpm) low grade fever and felt very weak.
The patent was taken to the emergency room (ER) at 30 hours post injection and it was determined (Xray, CTA & EKG) that she had a pleuralpericardial effusion.
She was flown by air life to another ER for treatment.
The patient underwent lab tests and procedures on 16Jan2021 which included angiogram (CTA): had a pleuralpericardial effusion; body temperature: low grade fever; electrocardiogram (EKG): had a pleuralpericardial effusion; heart rate: 100 beats per minute (bpm); X-ray: had a pleuralpericardial effusion.
The patient had a rapid nasal swab on 17Jan2021 which was negative.
Therapeutic measures were taken as a result of the events and included unspecified medications & oxygen therapy.
The outcome of the events was recovering.
The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.