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VAERS Report 2156930

Case Report Section

Vaer Report Details

Age: 62 years old

Gender: Female

State: Outside US

Patient Died?
No
Vaccine information

Name: COVID19 (COVID19 (MODERNA))

Type: Coronavirus 2019 vaccine

Manufacturer: MODERNA

Lot: 3005889


Date report was received
2022-03-04
Date form completed
Date Vaccinated
2022-02-24
Date of Onset
0
Number of days (onset date – vaccination date)
0
Adverse Event Description

lethargy; headache; nauseous; inflammation injection site; this case was received via regulatory authority (reference number: gb-mhra-adr 26657119) on 28-feb-2022 and was forwarded to moderna on 28-feb-2022. this regulatory authority case was reported by a consumer and describes the occurrence of lethargy (lethargy), headache (headache), nausea (nauseous) and injection site inflammation (inflammation injection site) in a 62-year-old female patient who received mrna-1273 (moderna covid-19 vaccine) (batch no. 3005889) for an unknown indication. concomitant products included covid-19 vaccine nrvv ad (chadox1 ncov-19) (covid-19 vaccine astrazeneca) from 15-mar-2021 to an unknown date and covid-19 vaccine nrvv ad (chadox1 ncov-19) (covid-19 vaccine astrazeneca) for an unknown indication. on 24-feb-2022, the patient received third dose of mrna-1273 (moderna covid-19 vaccine) (unknown route) 1 dosage form. on 24-feb-2022, the patient experienced lethargy (lethargy) (seriousness criterion medically significant), headache (headache) (seriousness criterion medically significant), nausea (nauseous) (seriousness criterion medically significant) and injection site inflammation (inflammation injection site) (seriousness criterion medically significant). at the time of the report, lethargy (lethargy), nausea (nauseous) and injection site inflammation (inflammation injection site) had not resolved and headache (headache) was resolving. the action taken with mrna-1273 (moderna covid-19 vaccine) (unknown) was unknown. patient was otherwise fit and well. patient did not had symptoms associated with covid-19 and did not had a covid-19 test. patient had not tested positive for covid-19 since she had received the vaccine. this report was not related to possible inflammation of the heart (myocarditis or pericarditis). no treatment medication reported. company comment: this case concerns a 62-year-old female patient with no medical history reported, who experienced the unexpected, serious (medically significant) events of lethargy, headache, and nausea the same day after the third dose of mrna-1273. information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. seriousness assessment has been retained as per regulatory authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. the benefit-risk relationship of mrna-1273 is not affected by this report.; sender's comments: this case concerns a 62-year-old female patient with no medical history reported, who experienced the unexpected, serious (medically significant) events of lethargy, headache, and nausea the same day after the third dose of mrna-1273. information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. seriousness assessment has been retained as per regulatory authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. the benefit-risk relationship of mrna-1273 is not affected by this report

Lab Data
na
List of symptoms
injection site inflammation nausea headache lethargy
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?
No
Allergies:
na
Current Illness
na