Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pyrexia, SARS-CoV-2 test, Vaccination site erythema
Clinical narrative: was not feeling well/did not feel good; was sleeping 18-20 hours a day; was still very sick/is seriously ill, has serious illness; Had no taste; No smell; Had no energy; Fever/patient ran fever on/off/ran high fever; Nauseous; her arm turned hot that evening/it was hot to the touch; arm was red hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (her arm turned hot that evening/it was hot to the touch), MALAISE (was not feeling well/did not feel good), HYPERSOMNIA (was sleeping 18-20 hours a day), ILLNESS (was still very sick/is seriously ill, has serious illness) and AGEUSIA (Had no taste) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2021, the patient experienced VACCINATION SITE WARMTH (her arm turned hot that evening/it was hot to the touch) and VACCINATION SITE ERYTHEMA (arm was red hot). On an unknown date, the patient experienced MALAISE (was not feeling well/did not feel good), HYPERSOMNIA (was sleeping 18-20 hours a day), ILLNESS (was still very sick/is seriously ill, has serious illness), AGEUSIA (Had no taste), ANOSMIA (No smell), ASTHENIA (Had no energy), PYREXIA (Fever/patient ran fever on/off/ran high fever) and NAUSEA (Nauseous). At the time of the report, VACCINATION SITE WARMTH (her arm turned hot that evening/it was hot to the touch), MALAISE (was not feeling well/did not feel good), HYPERSOMNIA (was sleeping 18-20 hours a day), AGEUSIA (Had no taste), ANOSMIA (No smell), ASTHENIA (Had no energy), VACCINATION SITE ERYTHEMA (arm was red hot) and NAUSEA (Nauseous) outcome was unknown and ILLNESS (was still very sick/is seriously ill, has serious illness) and PYREXIA (Fever/patient ran fever on/off/ran high fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, SARS-CoV-2 test: negative (Negative) A negative test prior to the 1st dose of Moderna vaccine. On an unknown date, SARS-CoV-2 test: negative (Negative) Went it to get the covid-19 test again and it was negative and negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant product use was reported.  The reporter was calling on behalf of their daughter who was the patient and stated that after the patient received the 1st dose of the Moderna vaccine, their arm turned hot that evening, arm was red hot, it was hot to the touch, started with a fever and was not feeling well. The reporter stated that the patient had a negative test prior to the 1st dose of Moderna vaccine as the patient was exposed to someone on 22-Dec-2021.  The reporter stated that the patient did not feel good, went it to get the covid-19 test again and it was negative. The daughter went to the urgent care as she was still very sick, and the urgent care told the patient to go to the hospital to get a swab test. The patient ran fever on/off, had no taste, no smell, nauseous, had no energy and was sleeping 18-20 hours a day which stated was not like patient. The patient went for a 4th test as the patient had all the symptoms of Covid-19 and the test was also negative on the 4th try. The reporter stated that the patient was seriously ill and was going back to work or else patient could lose their job. The reporter stated that this had lasted 9 days, and all the patient's symptoms coincide with the Covid virus, was seriously ill, had serious illness and ran high fever. No treatment information was provided. Company comment:This is a case concerning a 19-year-old female patient with no medical history provided, who experienced the unexpected AESI events of Hypersomnia, Ageusia, Anosmia and other nonserious events. These events occurred on unknown date after patient received the first dose of mRNA-1273. There is no medical assessment or treatment has been informed and outcome was reported as unknown. Reportedly, SARS-CoV-2 test was negative which was done on unknown date prior to vaccination and on unknown date after the vaccination. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This is a case concerning a 19-year-old female patient with no medical history provided, who experienced the unexpected AESI events of Hypersomnia, Ageusia, Anosmia and other nonserious events. These events occurred on unknown date after patient received the first dose of mRNA-1273. There is no medical assessment or treatment has been informed and outcome was reported as unknown. Reportedly, SARS-CoV-2 test was negative which was done on unknown date prior to vaccination and on unknown date after the vaccination. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.