Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Insomnia, Loss of personal independence in daily activities, Nausea, Pain
Clinical narrative: insomnia; stop breathing for 5-10 seconds at a time; have lost their sense of taste and smell; not been able to work; have lost their sense of taste and smell; constipation got worse; second dose of the vaccine the aches started to come back; bad headaches; feel nausea; First dose 17NOV2021 and Second dose on 24FEB2022; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose 17NOV2021 and Second dose on 24FEB2022), INSOMNIA (insomnia), DYSPNOEA (stop breathing for 5-10 seconds at a time), AGEUSIA (have lost their sense of taste and smell) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not been able to work) in a 22-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 012H21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Feb-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 24-Feb-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose 17NOV2021 and Second dose on 24FEB2022). On an unknown date, the patient experienced INSOMNIA (insomnia), DYSPNOEA (stop breathing for 5-10 seconds at a time), AGEUSIA (have lost their sense of taste and smell), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not been able to work), ANOSMIA (have lost their sense of taste and smell), CONSTIPATION (constipation got worse), PAIN (second dose of the vaccine the aches started to come back), HEADACHE (bad headaches) and NAUSEA (feel nausea). The patient was treated with TESTOSTERONE at a dose of Took shot last week. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose 17NOV2021 and Second dose on 24FEB2022), INSOMNIA (insomnia), DYSPNOEA (stop breathing for 5-10 seconds at a time), AGEUSIA (have lost their sense of taste and smell), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not been able to work), ANOSMIA (have lost their sense of taste and smell), CONSTIPATION (constipation got worse), PAIN (second dose of the vaccine the aches started to come back), HEADACHE (bad headaches) and NAUSEA (feel nausea) outcome was unknown.            Concomitant products were not provided. It was reported that about 1 week ago patient felt they contracted COVID-19. Patient had an appointment for a COVID-19 test later this week. Patient spoke to the nurse that administered the vaccine, and went to the ER for their symptoms. Patient had taken supplements and pain killers for symptoms as treatment. Additionally patient took a testosterone shot last week, it was the first testosterone shot. Company comment: This spontaneous case concerns a 22-year-old, male patient with no reported medical history, who experienced the unexpected, non-serious. The exact date of onset of the events was not specified in respect to the administration of second dose of mRNA-1273, hence latency could not be assessed. The first dose of mRNA-1273 was given 90 days prior. It was reported that the patient experienced COVID-like symptoms and was scheduled for a COVID-19 test. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-553140 (Patient Link). Sender's Comments: This spontaneous case concerns a 22-year-old, male patient with no reported medical history, who experienced the unexpected, non-serious . The exact date of onset of the events was not specified in respect to the administration of second dose of mRNA-1273, hence latency could not be assessed. The first dose of mRNA-1273 was given 90 days prior. It was reported that the patient experienced COVID-like symptoms and was scheduled for a COVID-19 test. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.