Vaer Report Details
Age: 78 years old
Gender: Male
State: Outside US
- Patient Died?
- No
- Vaccine information
-
Name: COVID19 (COVID19 (MODERNA))
Type: Coronavirus 2019 vaccine
Manufacturer: MODERNA
Lot: 216035
- Date report was received
- 2022-03-04
- Date form completed
- Date Vaccinated
- 2022-01-28
- Date of Onset
- 0
- Number of days (onset date – vaccination date)
- 0
- Adverse Event Description
-
severe chest pain that spread down under his arm to stomach area; loss of appetite; severe chest pain that spread down under his arm to stomach area; severe chest pain that spread down under his arm to stomach area; weak with pain; discoloured face; this case was received via regulatory authority (reference number: ie-ra-2022-092203) on 25-feb-2022 and was forwarded to moderna on 25-feb-2022. this regulatory authority case was reported by a consumer and describes the occurrence of chest pain (severe chest pain that spread down under his arm to stomach area), decreased appetite (loss of appetite), axillary pain (severe chest pain that spread down under his arm to stomach area), abdominal pain upper (severe chest pain that spread down under his arm to stomach area), asthenia (weak with pain) and skin discolouration (discoloured face) in a 78-year-old male patient who received mrna-1273 (spikevax) (batch no. 216035) for covid-19 vaccination. previously administered products included for covid-19 immunization: comirnaty. past adverse reactions to the above products included no adverse event with comirnaty. on 28-jan-2022, the patient received third dose of mrna-1273 (spikevax) (unknown route) 1 dosage form. in january 2022, the patient experienced chest pain (severe chest pain that spread down under his arm to stomach area) (seriousness criteria hospitalization, medically significant and life threatening), decreased appetite (loss of appetite) (seriousness criteria hospitalization, medically significant and life threatening), axillary pain (severe chest pain that spread down under his arm to stomach area) (seriousness criteria hospitalization, medically significant and life threatening), abdominal pain upper (severe chest pain that spread down under his arm to stomach area) (seriousness criteria hospitalization, medically significant and life threatening), asthenia (weak with pain) (seriousness criteria hospitalization, medically significant and life threatening) and skin discolouration (discoloured face) (seriousness criteria hospitalization, medically significant and life threatening). at the time of the report, chest pain (severe chest pain that spread down under his arm to stomach area), decreased appetite (loss of appetite), axillary pain (severe chest pain that spread down under his arm to stomach area), abdominal pain upper (severe chest pain that spread down under his arm to stomach area), asthenia (weak with pain) and skin discolouration (discoloured face) had not resolved. diagnostic results (normal ranges are provided in parenthesis if available): on an unknown date, blood test: results not reported results not provided. concomitant medications were not provided by the reporter. dosage text was reported as booster dose. treatment information was not provided. company comment: this regulatory case concerns a 78-year-old, male patient with no relevant medical history, who experienced the unexpected, serious (hospitalized, disability, medically significant) events of chest pain with axillary pain and abdominal pain along with asthenia, decreased appetite and skin discolouration. the events occurred 48 hours after receiving the booster dose of mrna-1273 vaccine. it should also be noted that the patient previously received another brand of covid-19 vaccine, comirnaty, on an unspecified date (interchange of vaccine products). on an unknown date, blood tests were conducted but results were not provided in the case. clinical course and treatment details were also not disclosed. at the time of reporting, the patient has not recovered from the events. the benefit-risk relationship of mrna-1273 is not affected by this report. events' seriousness was assessed as per regulatory authority's report, however there was no information in the source document supporting that the events were life-threatening and resulted in a persistent or permanent incapacity. sender's comments: this regulatory case concerns a 78-year-old, male patient with no relevant medical history, who experienced the unexpected, serious (hospitalized, disability, medically significant) events of chest pain with axillary pain and abdominal pain along with asthenia, decreased appetite and skin discolouration. the events occurred 48 hours after receiving the booster dose of mrna-1273 vaccine. it should also be noted that the patient previously received another brand of covid-19 vaccine, comirnaty, on an unspecified date (interchange of vaccine products). on an unknown date, blood tests were conducted but results were not provided in the case. clinical course and treatment details were also not disclosed. at the time of reporting, the patient has not recovered from the events. the benefit-risk relationship of mrna-1273 is not affected by this report. events' seriousness was assessed as per regulatory authority's report, however there was no information in the source document supporting that the events were life-threatening and resulted in a persistent or permanent incapacity
- Lab Data
-
test name: blood test; result unstructured data: results not provided
- List of symptoms
-
chest pain decreased appetite asthenia skin discolouration abdominal pain upper axillary pain blood test
- Patient Died?
- No
- Date Died
- NA
- Birth defect
- false
- Vaccine Administered By:
- Unknown
- Vaccine Purchased By:
- Unknown
- Patient visit ER?
- No
- Patient Hospitalized?
- Yes
- Stay in hospital
- No
- Days in hospital
- Unspecified
- Permanent disability?
- No
- Allergies:
-
na
- Current Illness
-
na