Adverse Event Reporting
| VAERS ID | 908248 |
|---|---|
| Gender | Female |
| Age | |
| StateCode | FR |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | E50553 |
| Number of vaccinations | |
| Vaccinated | 2020-12-10 |
| Onset | 2020-12-10 |
| Condition | Permanent Disability |
Symptoms
- Arthralgia
- Fatigue
- Pain in extremity
- Pyrexia
- Headache
- Dizziness
- Chills
- Nausea
- Myalgia
- Photophobia
- SARS-CoV-2 antibody test
Current Illness
Preexisting Conditions
Medical History/Concurrent Conditions: Blood test; Clinical trial participant ((study and Study (staff only))); COVID-19 ((Patient had severe Covid March 18th for one month)); COVID-19 PCR test negative; Irritable bowel syndrome; Comments: In regard to antibodies on the studies - patient had high detectable antibodies since April (on study staff only) and from August (on study). Patient has not had symptoms associated with COVID-19 Patient is not pregnant
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Test Date: 20201214; Test Name: COVID-19 antibody test; Result Unstructured Data: Test Result:Lateral flow test - negative
Write-up
Muscle ache; Headache; Light sensitivity to eye; Joint ache; Feverish; Chills; Nausea; Sore arm; Fatigue; Light headedness; This is a spontaneous report a contactable other hcp downloaded from the Regulatory Authority.
Regulatory authority GB-MHRA-WEBCOVID-20201215061410, Safety Report Unique Identifier GB-MHRA-ADR 24543243.
A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number E50553, with unknown expiration date), via an unspecified route of administration on 10Dec2020 at single dose for covid-19 immunisation.
Medical history included blood test from 10Dec2020 to an unknown date, irritable bowel syndrome from an unknown date and unknown if ongoing, clinical trial participant from an unknown date and unknown if ongoing (study and Study (staff only)), covid-19 from 18Mar2020 to Apr2020 (Patient had severe Covid March 18th for one month), COVID-19 PCR test negative from 10Dec2020 to an unknown date.
The patient's concomitant medications were not reported.
The patient experienced muscle ache on 11Dec2020, headache on 11Dec2020, light headedness on 10Dec2020, light sensitivity to eye on 11Dec2020, fatigue on 10Dec2020, joint ache on 11Dec2020, sore arm on 10Dec2020, feverish on 11Dec2020, chills on 11Dec2020, nausea on 10Dec2020.
All events were serious with criteria of disability, medically significant.
Patient has not tested positive for COVID-19 since having the vaccine.
Lateral flow test 14Dec20 negative.
Had bloods, antibody tests and PCR swabs done 10dec20 before vaccine given.
The outcome of the event sore arm was recovering, the outcome of event Light headedness was recovered on 11Dec2020, while the outcome of the other events was recovered on 13Dec2020.
No follow-up attempts possible.
No further information expected.
Information on lot # already obtained.