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VAERS Report 2156878

Case Report Section

Vaer Report Details

Age: NA

Gender: Female

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
2022-02-22
Date of Onset
0
Number of days (onset date – vaccination date)
0
Adverse Event Description

sore throat; runny nose; cluster headache; myasthenia; insomnia; this case was received via regulatory authority (reference number: gb-ra-adr 26639254) on 24-feb-2022 and was forwarded to moderna on 24-feb-2022. this regulatory authority case was reported by a consumer and describes the occurrence of oropharyngeal pain (sore throat), rhinorrhoea (runny nose), cluster headache (cluster headache), muscular weakness (myasthenia) and insomnia (insomnia) in a female patient of an unknown age who received mrna-1273 (moderna covid-19 vaccine) for an unknown indication. the patient's past medical history included breast cancer, myasthenia and neoplasm (recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy)). concomitant products included covid-19 vaccine mrna (bnt162b2) for an unknown indication. on 22-feb-2022, the patient received dose of mrna-1273 (moderna covid-19 vaccine) (unknown route) 1 dosage form. on 22-feb-2022, the patient experienced oropharyngeal pain (sore throat) (seriousness criterion medically significant), rhinorrhoea (runny nose) (seriousness criterion medically significant), cluster headache (cluster headache) (seriousness criterion medically significant), muscular weakness (myasthenia) (seriousness criterion medically significant) and insomnia (insomnia) (seriousness criterion medically significant). at the time of the report, oropharyngeal pain (sore throat), rhinorrhoea (runny nose) and cluster headache (cluster headache) was resolving, muscular weakness (myasthenia) had resolved and insomnia (insomnia) had not resolved. diagnostic results (normal ranges are provided in parenthesis if available): on 23-feb-2022, sars-cov-2 test: no - negative covid-19 test (negative) no - negative covid-19 test. the action taken with mrna-1273 (moderna covid-19 vaccine) (unknown) was unknown. patient has not had symptoms associated with covid-19. patient has not tested positive for covid-19 since having the vaccine. patient is not enrolled in clinical trial. this report was not related to possible inflammation of the heart (myocarditis or pericarditis). no treatment medication was reported. company comment: this regulatory authority case of interchange of vaccine products, concerns a female patient of an unknown age, with relevant medical history of myasthenia and neoplasm (recently had treatment for cancer, leukemia or lymphoma (radiotherapy or chemotherapy) and previous vaccination of covid-19 vaccine mrna (bnt162b2), who experienced the unexpected serious (medically significant) events of oropharyngeal pain, rhinorrhea, cluster headache, muscular weakness and insomnia. the events occurred approximately 1 day after receiving a dose of mrna-1273 vaccine. at the time of the report the outcome of the events was not resolved. the patient's medical history of myasthenia and neoplasm (recently had treatment for cancer, leukemia or lymphoma (radiotherapy or chemotherapy), remain as confounders for the occurrence of the events. event seriousness assessed as per regulatory authority report. the benefit-risk relationship of mrna-1273 vaccine is not affected by this report.; sender's comments: this regulatory authority case of interchange of vaccine products, concerns a female patient of an unknown age, with relevant medical history of myasthenia and neoplasm (recently had treatment for cancer, leukemia or lymphoma (radiotherapy or chemotherapy) and previous vaccination of covid-19 vaccine mrna (bnt162b2), who experienced the unexpected serious (medically significant) events of oropharyngeal pain, rhinorrhea, cluster headache, muscular weakness and insomnia. the events occurred approximately 1 day after receiving a dose of mrna-1273 vaccine. at the time of the report the outcome of the events was not resolved. the patient's medical history of myasthenia and neoplasm (recently had treatment for cancer, leukemia or lymphoma (radiotherapy or chemotherapy), remain as confounders for the occurrence of the events. event seriousness assessed as per regulatory authority report. the benefit-risk relationship of mrna-1273 vaccine is not affected by this report

Lab Data
test date: 20220223; test name: covid-19 virus test; test result: negative; result unstructured data: no - negative covid-19 test
List of symptoms
insomnia rhinorrhoea muscular weakness oropharyngeal pain sars-cov-2 test cluster headache
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