Vaer Report Details
Age: 32 years old
Gender: Female
State: Outside US
- Patient Died?
- No
- Vaccine information
-
Name: COVID19 (COVID19 (MODERNA))
Type: Coronavirus 2019 vaccine
Manufacturer: MODERNA
Lot: 000063a
- Date report was received
- 2022-03-04
- Date form completed
- Date Vaccinated
- 2022-02-05
- Date of Onset
- 1
- Number of days (onset date – vaccination date)
- 1
- Adverse Event Description
-
approximately 20 hours after i dose spikevax access in dea for crampform pain left leg with paresthesia (tingling) upper limbs and left hemithorax. to date, lower back pain and tingling aass; approximately 20 hours after i dose spikevax access in dea for crampform pain left leg with paresthesia (tingling) upper limbs and left hemithorax. to date, lower back pain and tingling aass; approximately 20 hours after i dose spikevax access in dea for crampform pain left leg with paresthesia (tingling) upper limbs and left hemithorax. to date, lower back pain and tingling aass; approximately 20 hours after i dose spikevax access in dea for crampform pain left leg with paresthesia (tingling) upper limbs and left hemithorax. to date, lower back pain and tingling aass; this case was received (reference number: it-minisal02-840911) on 24-feb-2022 and was forwarded to moderna on 24-feb-2022. this regulatory authority case was reported by a physician and describes the occurrence of paraesthesia (approximately 20 hours after i dose spikevax access in dea for crampform pain left leg with paresthesia (tingling) upper limbs and left hemithorax. to date, lower back pain and tingling aass), back pain (approximately 20 hours after i dose spikevax access in dea for crampform pain left leg with paresthesia (tingling) upper limbs and left hemithorax. to date, lower back pain and tingling aass), pain in extremity (approximately 20 hours after i dose spikevax access in dea for crampform pain left leg with paresthesia (tingling) upper limbs and left hemithorax. to date, lower back pain and tingling aass) and haemothorax (approximately 20 hours after i dose spikevax access in dea for crampform pain left leg with paresthesia (tingling) upper limbs and left hemithorax. to date, lower back pain and tingling aass) in a 32-year-old female patient who received mrna-1273 (spikevax) (batch no. 000063a) for covid-19 vaccination. no medical history information was reported. on 05-feb-2022, the patient received dose of mrna-1273 (spikevax) (intramuscular) 1 dosage form. on 06-feb-2022, the patient experienced paraesthesia (approximately 20 hours after i dose spikevax access in dea for crampform pain left leg with paresthesia (tingling) upper limbs and left hemithorax. to date, lower back pain and tingling aass) (seriousness criterion hospitalization), back pain (approximately 20 hours after i dose spikevax access in dea for crampform pain left leg with paresthesia (tingling) upper limbs and left hemithorax. to date, lower back pain and tingling aass) (seriousness criterion hospitalization), pain in extremity (approximately 20 hours after i dose spikevax access in dea for crampform pain left leg with paresthesia (tingling) upper limbs and left hemithorax. to date, lower back pain and tingling aass) (seriousness criterion hospitalization) and haemothorax (approximately 20 hours after i dose spikevax access in dea for crampform pain left leg with paresthesia (tingling) upper limbs and left hemithorax. to date, lower back pain and tingling aass) (seriousness criterion hospitalization). at the time of the report, paraesthesia (approximately 20 hours after i dose spikevax access in dea for crampform pain left leg with paresthesia (tingling) upper limbs and left hemithorax. to date, lower back pain and tingling aass), back pain (approximately 20 hours after i dose spikevax access in dea for crampform pain left leg with paresthesia (tingling) upper limbs and left hemithorax. to date, lower back pain and tingling aass), pain in extremity (approximately 20 hours after i dose spikevax access in dea for crampform pain left leg with paresthesia (tingling) upper limbs and left hemithorax. to date, lower back pain and tingling aass) and haemothorax (approximately 20 hours after i dose spikevax access in dea for crampform pain left leg with paresthesia (tingling) upper limbs and left hemithorax. to date, lower back pain and tingling aass) was resolving. diagnostic results (normal ranges are provided in parenthesis if available): on 06-feb-2022, computerised tomogram normal: negative (negative) negative. on 06-feb-2022, electrocardiogram normal: negative (negative) negative. for mrna-1273 (spikevax) (intramuscular), the reporter did not provide any causality assessments. no concomitant medications were reported. last dose date of suspect product was provided as 05-feb-2022. it was reported that after administration in dea of toradol and valium, chest and abdomen rash appear and feeling of heat, discontinued administration with benefit on the symptom. sender's comments: 08/02/2022 clinical documentation was attached. company comment: this regulatory authority case concerns a 32-year-old, female patient with no relevant medical history, who experienced the unexpected serious (hospitalization) events of paresthesia, back pain, pain in extremity, and hemothorax. the events occurred approximately 20 hours after an unknown dose of mrna-1273 (moderna covid-19 vaccine). computerized tomogram and electrocardiogram were both reported normal. the benefit-risk relationship of mrna-1273 (moderna covid-19 vaccine) is not affected by this report.; reporter's comments: after administration in dea of toradol and valium, chest and abdomen rash appear and feeling of heat, discontinued administration with benefit on the symptom; sender's comments: this regulatory authority case concerns a 32-year-old, female patient with no relevant medical history, who experienced the unexpected serious (hospitalization) events of paresthesia, back pain, pain in extremity, and hemothorax. the events occurred approximately 20 hours after an unknown dose of mrna-1273 (moderna covid-19 vaccine). computerized tomogram and electrocardiogram were both reported normal. the benefit-risk relationship of mrna-1273 (moderna covid-19 vaccine) is not affected by this report
- Lab Data
-
test date: 20220206; test name: cat normal; test result: negative ; result unstructured data: negative; test date: 20220206; test name: electrocardiogram normal; test result: negative ; result unstructured data: negative
- List of symptoms
-
paraesthesia back pain pain in extremity haemothorax computerised tomogram normal electrocardiogram normal
- 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