Adverse Event Reporting
| VAERS ID | 1277222 |
|---|---|
| Gender | Unknown |
| Age | 50 |
| StateCode | CT |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | EP6955 |
| Number of vaccinations | 1 |
| Vaccinated | 2021-03-23 |
| Onset | 2021-04-10 |
| Condition | Permanent Disability |
Symptoms
- Headache
- SARS-CoV-2 test
Current Illness
Preexisting Conditions
Medical History/Concurrent Conditions: Mitral valve repair (4 years ago)
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Test Date: 20210413; Test Name: Nasal Swab; Test Result: Negative
Write-up
Headache; This is a spontaneous report from a contactable other healthcare professional (patient) reported that a 50-year-old patient of an unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955) via an unspecified route of administration, administered in arm left on 23Mar2021 (at the age of 50-years-old) as a single dose for covid-19 immunisation.
The patient medical history included mitral valve repaired in 2017 (reported as 4 years ago).
The patient had no known allergies.
The patient's concomitant medications were not reported.
The patient had no other vaccines within four weeks.
The patient experienced headache on 10Apr2021 15:00 (03:00PM).
The event resulted in physician or other health professional office visit, disability or permanent damage.
The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 13Apr2021.
The patient received treatment for the event as doxycycline and prednisone were provided.
The outcome of the event was not recovered.
; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of headache due to temporal relationship and current known drug safety profile.
Case will be re-assessed upon the additional information provided.
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.