Adverse Event Reporting
| VAERS ID | 2474823 |
|---|---|
| Gender | Female |
| Age | 45 |
| StateCode | FR |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | EJ0563 |
| Number of vaccinations | 1 |
| Vaccinated | 2020-12-09 |
| Onset | 2022-10-05 |
| Condition | Permanent Disability |
Symptoms
- Fatigue
- Dizziness
- Tremor
- Pain
- Vomiting
- SARS-CoV-2 test
Current Illness
Psoriasis (on fortnightly amgevita injections)
Preexisting Conditions
Medical History/Concurrent Conditions: Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...)
Other Medications
AMGEVITA; FLUVAX
Previous Vaccinations
Allergies
Laboratory Data
Test Date: 20220113; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: test_result = Yes - Positive COVID-19 test;
Write-up
Dizziness; Vomiting; Tiredness; Ache; Shakiness; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 27372398) on 10-Oct-2022 and was forwarded to Moderna on 10-Oct-2022.
This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), VOMITING (Vomiting), FATIGUE (Tiredness), PAIN (Ache) and TREMOR (Shakiness) in a 45-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos.
000084A and 3005889) for COVID-19 prophylaxis.
Co-suspect products included non-company products TOZINAMERAN (COMIRNATY) for an unknown indication and TOZINAMERAN (COMIRNATY) for an unknown indication.
Concurrent medical conditions included Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i.
.
.
) and Psoriasis (on fortnightly amgevita injections).
Concomitant products included INFLUENZA VACCINE INACT SPLIT 3V (FLUVAX) from 03-Oct-2022 to an unknown date for Immunocompromised, ADALIMUMAB (AMGEVITA) from an unknown date to 29-Sep-2022 for Psoriasis.
On 09-Dec-2020, the patient started TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form.
On 08-Jan-2021, TOZINAMERAN (COMIRNATY) (unknown route) dosage was changed to 1 dosage form.
On 24-Sep-2021, TOZINAMERAN (COMIRNATY) (unknown route) dosage was changed to 1 dosage form.
On 16-Feb-2022, the patient received fourth dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form.
On 07-Jun-2022, received fifth dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.
On 04-Oct-2022, the patient received dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form.
On 05-Oct-2022, the patient experienced FATIGUE (Tiredness) (seriousness criteria disability and medically significant), PAIN (Ache) (seriousness criteria disability and medically significant) and TREMOR (Shakiness) (seriousness criteria disability and medically significant).
On 07-Oct-2022, the patient experienced DIZZINESS (Dizziness) (seriousness criteria disability and medically significant) and VOMITING (Vomiting) (seriousness criteria disability and medically significant).
At the time of the report, DIZZINESS (Dizziness), VOMITING (Vomiting), FATIGUE (Tiredness), PAIN (Ache) and TREMOR (Shakiness) had not resolved.
DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2022, SARS-CoV-2 test: (Positive) test_result = Yes - Positive COVID-19 test;.
The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown.
Patient has not had symptoms associated with COVID-19.
Patient was not currently breastfeeding.
Patient had not tested positive for COVID-19 since having the vaccine.
Patient was not enrolled in clinical trial.
The patients report did not relate to possible myocarditis or pericarditis.
Treatment information was not provided.
Company comment-This regulatory case reported by a consumer concerns a female patient aged 45 years with no relevant medical history reported, who experienced unexpected serious (medically significant/Disability) events of Dizziness, Vomiting, Fatigue, Pain and Tremor approximately four months after 5th dose of mRNA-1273 vaccination in covid-19 vaccination series.
Patient had received initial 3 doses of co-suspect Comirnaty followed by 4th and 5th dose of mRNA-1273 vaccine and unspecified dose of co-suspect Comirnaty approximately 4 months later (Interchange of vaccine products noted).
The events occurred 1-3 days after unspecified dose of co-suspect Comirnaty vaccination.
No further information on risk factors, concurrent illness, detailed clinical course, investigations, treatment of the events was available in the report.
Outcome of events was not resolved at the time of report.
The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
The case seriousness was assessed as per Regulatory Authority report.
; Sender's Comments: This regulatory case reported by a consumer concerns a female patient aged 45 years with no relevant medical history reported, who experienced unexpected serious (medically significant/Disability) events of Dizziness, Vomiting, Fatigue, Pain and Tremor approximately four months after 5th dose of mRNA-1273 vaccination in covid-19 vaccination series.
Patient had received initial 3 doses of co-suspect Comirnaty followed by 4th and 5th dose of mRNA-1273 vaccine and unspecified dose of co-suspect Comirnaty approximately 4 months later (Interchange of vaccine products noted).
The events occurred 1-3 days after unspecified dose of co-suspect Comirnaty vaccination.
No further information on risk factors, concurrent illness, detailed clinical course, investigations, treatment of the events was available in the report.
Outcome of events was not resolved at the time of report.
The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
The case seriousness was assessed as per Regulatory Authority report.