Vaer Report Details
Age: 42 years old
Gender: Male
State: Outside US
- Patient Died?
- No
- Vaccine information
-
Name: COVID19 (COVID19 (MODERNA))
Type: Coronavirus 2019 vaccine
Manufacturer: MODERNA
Lot: unknown
- Date report was received
- 2022-03-04
- Date form completed
- Date Vaccinated
- Date of Onset
- 0
- Number of days (onset date – vaccination date)
- 0
- Adverse Event Description
-
exhaustion; lymph nodes cervical swollen; this case was received via regulatory authority (reference number: gr-greof-20217507) on 01-mar-2022 and was forwarded to moderna on 01-mar-2022. this regulatory authority case was reported by a consumer and describes the occurrence of lymphadenopathy (lymph nodes cervical swollen) in a 42-year-old male patient who received mrna-1273 (spikevax) for covid-19 vaccination. the occurrence of additional non-serious events is detailed below. no medical history information was reported. on an unknown date, the patient received dose of mrna-1273 (spikevax) (intramuscular) 1 dosage form. on 01-sep-2021, the patient experienced fatigue (exhaustion) and lymphadenopathy (lymph nodes cervical swollen) (seriousness criterion disability). at the time of the report, fatigue (exhaustion) and lymphadenopathy (lymph nodes cervical swollen) had not resolved. the action taken with mrna-1273 (spikevax) (intramuscular) was unknown. no concomitant drug details were reported. no treatment details were reported. company comment: this regulatory case concerns a 42-year-old, male patient with no medical history reported, who experienced the unexpected, serious (seriousness criteria disability) event of lymphadenopathy an unknown duration after the unknown dose of mrna-1273. no relevant lab data or details regarding clinical course and treatment received were reported. at the time of report, outcome of the event was not resolved. the benefit-risk relationship of mrna-1273 vaccine is not affected by this report. event seriousness assessed as per regulatory authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.; sender's comments: this regulatory case concerns a 42-year-old, male patient with no medical history reported, who experienced the unexpected, serious (seriousness criteria disability) event of lymphadenopathy an unknown duration after the unknown dose of mrna-1273. no relevant lab data or details regarding clinical course and treatment received were reported. at the time of report, outcome of the event was not resolved. the benefit-risk relationship of mrna-1273 vaccine is not affected by this report. event seriousness assessed as per regulatory authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity
- Lab Data
-
na
- List of symptoms
-
fatigue lymphadenopathy
- Patient Died?
- No
- Date Died
- NA
- Birth defect
- false
- Vaccine Administered By:
- Unknown
- Vaccine Purchased By:
- Unknown
- Patient visit ER?
- No
- Patient Hospitalized?
- No
- Stay in hospital
- No
- Days in hospital
- Unspecified
- Permanent disability?
- Yes
- Allergies:
-
na
- Current Illness
-
na