Vaer Report Details
Age: 12 years old
Gender: Female
State: Outside US
- Patient Died?
- No
- Vaccine information
-
Name: COVID19 (COVID19 (MODERNA))
Type: Coronavirus 2019 vaccine
Manufacturer: MODERNA
Lot: 000033a
- Date report was received
- 2022-03-04
- Date form completed
- Date Vaccinated
- 2022-01-18
- Date of Onset
- 0
- Number of days (onset date – vaccination date)
- 0
- Adverse Event Description
-
in the evening symptoms appeared: fever 39.5, sore throat, lack of appetite, headache, pain in left injection site. symptoms for two days; in the evening symptoms appeared: fever 39.5, sore throat, lack of appetite, headache, pain in left injection site. symptoms for two days; in the evening symptoms appeared: fever 39.5, sore throat, lack of appetite, headache, pain in left injection site. symptoms for two days; in the evening symptoms appeared: fever 39.5, sore throat, lack of appetite, headache, pain in left injection site. symptoms for two days; in the evening symptoms appeared: fever 39.5, sore throat, lack of appetite, headache, pain in left injection site. symptoms for two days; this case was received via the ra (reference number: it-minisal02-840355) on 23-feb-2022 and was forwarded to moderna on 23-feb-2022. this regulatory authority case was reported by a pharmacist and describes the occurrence of hyperpyrexia (in the evening symptoms appeared: fever 39.5, sore throat, lack of appetite, headache, pain in left injection site. symptoms for two days), administration site pain (in the evening symptoms appeared: fever 39.5, sore throat, lack of appetite, headache, pain in left injection site. symptoms for two days), headache (in the evening symptoms appeared: fever 39.5, sore throat, lack of appetite, headache, pain in left injection site. symptoms for two days), oropharyngeal pain (in the evening symptoms appeared: fever 39.5, sore throat, lack of appetite, headache, pain in left injection site. symptoms for two days) and decreased appetite (in the evening symptoms appeared: fever 39.5, sore throat, lack of appetite, headache, pain in left injection site. symptoms for two days) in a 12-year-old female patient who received mrna-1273 (spikevax) (batch no. 000033a) for covid-19 vaccination. no medical history information was reported. on 18-jan-2022, the patient received dose of mrna-1273 (spikevax) (intramuscular) .5 milliliter. on 18-jan-2022, the patient experienced hyperpyrexia (in the evening symptoms appeared: fever 39.5, sore throat, lack of appetite, headache, pain in left injection site. symptoms for two days) (seriousness criterion medically significant), administration site pain (in the evening symptoms appeared: fever 39.5, sore throat, lack of appetite, headache, pain in left injection site. symptoms for two days) (seriousness criterion medically significant), headache (in the evening symptoms appeared: fever 39.5, sore throat, lack of appetite, headache, pain in left injection site. symptoms for two days) (seriousness criterion medically significant), oropharyngeal pain (in the evening symptoms appeared: fever 39.5, sore throat, lack of appetite, headache, pain in left injection site. symptoms for two days) (seriousness criterion medically significant) and decreased appetite (in the evening symptoms appeared: fever 39.5, sore throat, lack of appetite, headache, pain in left injection site. symptoms for two days) (seriousness criterion medically significant). at the time of the report, hyperpyrexia (in the evening symptoms appeared: fever 39.5, sore throat, lack of appetite, headache, pain in left injection site. symptoms for two days), administration site pain (in the evening symptoms appeared: fever 39.5, sore throat, lack of appetite, headache, pain in left injection site. symptoms for two days), headache (in the evening symptoms appeared: fever 39.5, sore throat, lack of appetite, headache, pain in left injection site. symptoms for two days), oropharyngeal pain (in the evening symptoms appeared: fever 39.5, sore throat, lack of appetite, headache, pain in left injection site. symptoms for two days) and decreased appetite (in the evening symptoms appeared: fever 39.5, sore throat, lack of appetite, headache, pain in left injection site. symptoms for two days) was resolving. for mrna-1273 (spikevax) (intramuscular), the reporter did not provide any causality assessments. no concomitant drug details were reported. 1st batch dose 094f21a administered on 21-dec-2021 no adrs no treatment details were reported. company comment: this regulatory case concerns a 12-year-old, female patient with no medical history reported, who experienced the unexpected, serious (medically significant) events of hyperpyrexia, administration site pain, headache, oropharyngeal pain and decreased appetite. the events occurred on the same day after administration of an unspecified dose of the moderna mrna-1273 vaccine. treatment information was not provided. however, the events were resolving at the time of the report. the benefit-risk relationship of the moderna mrna-1273 vaccine is not affected by this report.; sender's comments: this regulatory case concerns a 12-year-old, female patient with no medical history reported, who experienced the unexpected, serious (medically significant) events of hyperpyrexia, administration site pain, headache, oropharyngeal pain and decreased appetite. the events occurred on the same day after administration of an unspecified dose of the moderna mrna-1273 vaccine. treatment information was not provided. however, the events were resolving at the time of the report. the benefit-risk relationship of the moderna mrna-1273 vaccine is not affected by this report
- Lab Data
-
na
- List of symptoms
-
headache decreased appetite oropharyngeal pain hyperpyrexia administration site pain
- 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