Adverse Event Reporting
| VAERS ID | 918712 |
|---|---|
| Gender | Female |
| Age | 25 |
| StateCode | FR |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | |
| Number of vaccinations | |
| Vaccinated | 2020-12-14 |
| Onset | 2020-12-14 |
| Condition | Permanent Disability |
Symptoms
- Fatigue
- Headache
- Pain
- Malaise
- SARS-CoV-2 test
- Lymphadenopathy
- Vaccination site pain
Current Illness
Preexisting Conditions
Medical History/Concurrent Conditions: Anxiety attack; Chronic fatigue; Depression; Ehlers-Danlos syndrome (queried); Fibromyalgia; Hypermobility syndrome; Multiple allergies; Pain; Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial Patient is not pregnant
Other Medications
; ; ; PARACETAMOL AND CODEINE PHOSPHATE (I); ; ;
Previous Vaccinations
Allergies
Laboratory Data
Test Date: 20201210; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
Write-up
Enlarged lymph nodes (excl infective)/Swelling of lymph nodes; Feeling sick/Feeling unwell; Headache; Injection site pain; Fatigue; Pain; This is a spontaneous report from a contactable consumer received from the from the Medicines Agency (EMA) Regulatory Authority-WEB.
Regulatory authority number (GB-MHRA-WEBCOVID-20201216201312).
Safety Report Unique Identifier (GB-MHRA-ADR 24544034).
A 25-year-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration on 14Dec2020 at single dose for COVID-19 vaccination.
Medical history included hypermobility syndrome from an unknown date and unknown if ongoing, Chronic fatigue from an unknown date and unknown if ongoing, Ehlers-Danlos syndrome from an unknown date and unknown if ongoing queried, fibromyalgia from an unknown date and unknown if ongoing, Anxiety attack, Depression, pain and Multiple allergies.
Concomitant medication included propranolol hydrochloride for Anxiety attack, sertraline for Depression, omeprazole, codeine phosphate hemihydrate, paracetamol (PARACETAMOL AND CODEINE PHOSPHATE (I) for Pain, fexofenadine hydrochloride for Multiple allergies, diclofenac sodium for Pain, imipramine for Pain.
Patient has not had symptoms associated with COVID-19.
Patient is not enrolled in clinical trial Patient is not pregnant.
The patient experienced enlarged lymph nodes (excl infective) on 15Dec2020 with outcome of not recovered, feeling sick on 14Dec2020 with outcome of recovering, headache on 14Dec2020 with outcome of recovered on 15Dec2020, injection site pain on 14Dec2020 with outcome of not recovered, fatigue on 14Dec2020 with outcome of recovering, pain on 14Dec2020 with outcome of not recovered.
Patient had feeling sick.
Pain at injection site beginning from time of injection at around 11am on 14Dec2020, severe fatigue started around 2pm same day.
Headache, feeling unwell, severe pain beginning around 6pm same day.
Headache subsided 15Dec2020.
Swelling of lymph nodes upon waking on 15Dec2020.
Very severe pain limiting movement and daily activity, still severe fatigue.
Fatigue starting to ease 16Dec2020.
Feeling unwell starting to subside 16Dec2020.
Ongoing severe pain, still limiting activity.
Swollen glands still very uncomfortable.
Patient has not tested positive for coronavirus disease (COVID-19) since having the vaccine.
The patient underwent lab tests and procedures which included COVID-19 virus test: no-negative covid-19 test on 10Dec2020.
The seriousness criteria was reported as disability and medically significant.
No follow-up attempts possible.
No further information expected.
Lot/batch number was not provided and unable to obtain.