Adverse Event Reporting
| VAERS ID | 910481 |
|---|---|
| Gender | Female |
| Age | 36 |
| StateCode | FR |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | EJ0553 |
| Number of vaccinations | |
| Vaccinated | 2020-12-12 |
| Onset | 2020-12-12 |
| Condition | Permanent Disability |
Symptoms
- Pain in extremity
- Headache
- Chest discomfort
- Chills
- Palpitations
- Malaise
- Tachycardia
- SARS-CoV-2 test
- Asthma
- Vaccination site pain
Current Illness
Allergic asthma (Severe asthma with related allergies (pets, dust etc) no food or medical allergies.)
Preexisting Conditions
Medical History/Concurrent Conditions: Allergy to animals (pets, severe allergies); Dust allergy (severe allergies); Ehlers-Danlos syndrome; Supraventricular tachycardia; Comments: Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient is not pregnant.
Other Medications
; ; ; FOSTAIR
Previous Vaccinations
Allergies
Laboratory Data
Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative COVID-19 test; Comments: No - Negative COVID-19 test
Write-up
Palpitations and tachycardia; Palpitations and tachycardia; Vaccination site pain; Intense headache; Severe arm pain; Worsening asthma; Chills; Chest tightness; feeling generally unwell; This is a spontaneous report from a contactable consumer downloaded from agency and from the Medicines Agency (MA) Regulatory authority-WEB (GB-MHRA-WEBCOVID-20201213163748).
Safety Report Unique Identifier is GB-MHRA-ADR 24542779.
A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ0553) via an unspecified route of administration on 12Dec2020 at a single dose for COVID-19 immunization.
Medical history included supraventricular tachycardia, and Ehlers-Danlos syndrome, dust allergy (severe allergies), ongoing asthma (severe asthma with related allergies (pets, dust etc) no food or medical allergies), allergy to animal (pets, severe allergies).
Concomitant medications included salbutamol, montelukast for asthma, fexofenadine for asthma, beclometasone dipropionate/formoterol fumarate (FOSTAIR) for Asthma.
Patient had not had symptoms associated with COVID-19.
Patient was not enrolled in clinical trial.
Patient was not pregnant.
The patient experienced palpitations and tachycardia (disability) on 12Dec2020 with outcome of recovering, vaccination site pain (disability) on 12Dec2020 with outcome of unknown, intense headache (disability) on 12Dec2020 with outcome of recovered on an unknown date in Dec2020, severe arm pain (disability) on 12Dec2020 with outcome of not recovered, worsening asthma (disability) on 12Dec2020 with outcome of not recovered, chills (disability) on 12Dec2020 with outcome of not recovered, chest tightness (disability) on 12Dec2020 with outcome of not recovered.
Clinical course as follow: within approximately one hour severe headache reported.
Within several hours chest tightness and palpitations.
No shortness of breath (SOB) though or chest pain.
Throughout night developed worsening arm pain, not just at site but entire limb.
Following morning headache improving but arm pain worsening, could not drive or place any pressure around arm.
Tight chest ongoing (using inhalers approximately 5 times in one day).
After approximately 18 hours complaints of chills and feeling generally unwell (with outcome of unknown).
With exception of headache all symptoms worsening at the point of 24 hours.
Had to leave work (is a nurse) due to severity and unable to raise/use arm.
Patient had not tested positive for COVID-19 since having the vaccine.
The clinical setting the vaccine was given (community, hospital etc) was Hospital setting.
It was reported as general observations.
No red flags or anaphylaxis.
Patient had not had symptoms associated with COVID-19.
Patient was not enrolled in clinical trial.
The patient underwent lab tests and procedures which included COVID-19 virus test: negative COVID-19 test (no - negative COVID-19 test) on an unspecified date.
No follow-up attempts are possible, no further information expected.