Adverse Event Reporting

VAERS ID 1957035
Gender Male
Age 83
StateCode FR
Pharmaceutical Company MODERNA
Lot Number
Number of vaccinations 3
Vaccinated 2021-11-26
Onset 2021-11-30
Condition Life Threatening
Symptoms
  • Pyrexia
  • Hyperhidrosis
  • SARS-CoV-2 test

Current Illness

Preexisting Conditions

Other Medications

COVID-19 VACCINE ASTRAZENECA; COVID-19 VACCINE ASTRAZENECA

Previous Vaccinations

Allergies

Laboratory Data

Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test

Write-up

sweating; Fever; This case was received (Reference number: GB-MHRA-ADR 26295133) on 07-Dec-2021 and was forwarded to Moderna on 07-Dec-2021.
This regulatory authority case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating) and PYREXIA (Fever) in an 83-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication.
Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for COVID-19 immunization, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for COVID-19 vaccination.
On 26-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form.
On 30-Nov-2021, the patient experienced PYREXIA (Fever) (seriousness criteria medically significant and life threatening).
On an unknown date, the patient experienced HYPERHIDROSIS (sweating) (seriousness criteria medically significant and life threatening).
At the time of the report, HYPERHIDROSIS (sweating) had not resolved and PYREXIA (Fever) was resolving.
DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test.
The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown.
Patient had Fever, sweating profusely, and was drenched in sweat, had an enlarged testicle and penis swelling.
Patient has not tested positive for COVID-19 since having the vaccine.
Treatment information was not provided.
Company Comment: This case concerns an 83-year-old male subject, with no relevant medical history reported in this case, who experienced the serious unexpected events of Hyperhidrosis and Pyrexia.
The event Hyperhidrosis occurred on an unknown date and the outcome at the time of the report was Not Recovered/Not Resolved.
The event Pyrexia occurred approximately 4 days after the administration of the 3rd dose of the mRNA-1273 and the outcome at the time of the report was Recovering/Resolving.
The rechallenge is not applicable since the events occurred after the 3rd dose of the of the mRNA-1273 vaccine and another dose will not be administered.
The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
; Sender's Comments: This case concerns an 83-year-old male subject, with no relevant medical history reported in this case, who experienced the serious unexpected events of Hyperhidrosis and Pyrexia.
The event Hyperhidrosis occurred on an unknown date and the outcome at the time of the report was Not Recovered/Not Resolved.
The event Pyrexia occurred approximately 4 days after the administration of the 3rd dose of the mRNA-1273 and the outcome at the time of the report was Recovering/Resolving.
The rechallenge is not applicable since the events occurred after the 3rd dose of the of the mRNA-1273 vaccine and another dose will not be administered.
The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.