Adverse Event Reporting
| VAERS ID | 1964316 |
|---|---|
| Gender | Female |
| Age | 29 |
| StateCode | FR |
| Pharmaceutical Company | MODERNA |
| Lot Number | 214001 |
| Number of vaccinations | 1 |
| Vaccinated | 1992-07-01 |
| Onset | 2021-07-19 |
| Condition | Permanent Disability |
Symptoms
- Headache
- Acne
- Skin disorder
- Menstruation irregular
- Hormone level abnormal
Current Illness
Celiac disease
Preexisting Conditions
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Write-up
Regular cycles and hormones.
Since vaccine no longer; Sudden hormone levels without any reason; Very bright acne when I've never had this before; headache; Skin Problem; This case was received via RA (Reference number: BE-FAMHP-DHH-N2021-110013) on 10-Dec-2021 and was forwarded to Moderna on 10-Dec-2021.
This regulatory authority case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (Regular cycles and hormones.
Since vaccine no longer), HORMONE LEVEL ABNORMAL (Sudden hormone levels without any reason), ACNE (Very bright acne when I've never had this before), HEADACHE (headache) and SKIN DISORDER (Skin Problem) in a 29-year-old female patient who received mRNA-1273 (Spikevax) (batch no.
214001) for COVID-19 vaccination.
Concurrent medical conditions included Celiac disease.
On 01-Jul-1992, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form.
On 19-Jul-2021, the patient experienced MENSTRUATION IRREGULAR (Regular cycles and hormones.
Since vaccine no longer) (seriousness criterion disability), HORMONE LEVEL ABNORMAL (Sudden hormone levels without any reason) (seriousness criterion disability), ACNE (Very bright acne when I've never had this before) (seriousness criterion disability), HEADACHE (headache) (seriousness criterion disability) and SKIN DISORDER (Skin Problem) (seriousness criterion disability).
At the time of the report, MENSTRUATION IRREGULAR (Regular cycles and hormones.
Since vaccine no longer), HORMONE LEVEL ABNORMAL (Sudden hormone levels without any reason), ACNE (Very bright acne when I've never had this before), HEADACHE (headache) and SKIN DISORDER (Skin Problem) had not resolved.
Concomitant products were not provided.
Treatment medication were not reported.
Patient took moderna vaccine first dose with batch number 214001 and second dose on 28/07/21 with batch number 3003659.
Patient had very bright acne, sudden hormone levels without any reason.
Contraception has been stopped for 2 years.
Patient had regular cycles and hormones before vaccination.
Since vaccine no more and now 5 months later still not and the acne does not go away either.
Patient also experienced much more headache and trouble.
Acne is constant and does not improve, headache comes in wave.
Company Comment: This case concerns a 29-year-old female subject, with medical history of celiac disease, who experienced the unexpected and serious events of Menstruation irregular, Hormone level abnormal, Acne, Headache, and Skin disorder.
Drug start date was reported as 01-JUL-1992, which might probably be patient´s date of birth.
The events occurred after the second dose of mRNA-1273 vaccine.
The rechallenge is not applicable, as no additional dosing will be given.
The medical history remains confounder.
The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
; Sender's Comments: This case concerns a 29-year-old female subject, with medical history of celiac disease, who experienced the unexpected and serious events of Menstruation irregular, Hormone level abnormal, Acne, Headache, and Skin disorder.
Drug start date was reported as 01-JUL-1992, which might probably be patient´s date of birth.
The events occurred after the second dose of mRNA-1273 vaccine.
The rechallenge is not applicable, as no additional dosing will be given.
The medical history remains confounder.
The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.