Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Unable to return to work; Bad stomach ache; Difficulty sleeping due to his sore arm and crippling insomnia; Too tired during the day at work; Breathing problem where he could not catch his breath; Turned into anxiety because I could not breathe right; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED WORK ABILITY (Unable to return to work) and INSOMNIA (Difficulty sleeping due to his sore arm and crippling insomnia) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jul-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On 29-Aug-2021, the patient experienced DYSPNOEA (Breathing problem where he could not catch his breath) and ANXIETY (Turned into anxiety because I could not breathe right). On 02-Sep-2021, the patient experienced FATIGUE (Too tired during the day at work). On 13-Sep-2021, the patient experienced INSOMNIA (Difficulty sleeping due to his sore arm and crippling insomnia) (seriousness criterion medically significant). On 19-Oct-2021, the patient experienced IMPAIRED WORK ABILITY (Unable to return to work) (seriousness criterion medically significant) and ABDOMINAL PAIN UPPER (Bad stomach ache). The patient was treated with NAPROXEN for Pain in arm, at a dose of 375 milligram; CLONAZEPAM from 02-Sep-2021 to 17-Sep-2021 for Adverse event, at an unspecified dose and frequency; ALPRAZOLAM from 18-Sep-2021 to 18-Oct-2021 for Adverse event, at an unspecified dose and frequency; VENLAFAXINE on 19-Oct-2021 for Adverse event, at an unspecified dose and frequency; TRAZODONE on 21-Oct-2021 for Adverse event, at an unspecified dose and frequency and ESZOPICLONE on 22-Oct-2021 for Adverse event, at an unspecified dose and frequency. On 19-Oct-2021, ABDOMINAL PAIN UPPER (Bad stomach ache) had resolved. On 22-Oct-2021, INSOMNIA (Difficulty sleeping due to his sore arm and crippling insomnia) had resolved. At the time of the report, IMPAIRED WORK ABILITY (Unable to return to work), DYSPNOEA (Breathing problem where he could not catch his breath), ANXIETY (Turned into anxiety because I could not breathe right), VACCINATION SITE PAIN (Sore arm) and FATIGUE (Too tired during the day at work) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Oct-2021, SARS-CoV-2 test: negative (Negative) Negative.         Concomitant product use was not provided by the reporter.  Treatment medication also included Benadryl.  Company comment: This is Spontaneous case concerning a 64-year-old, male patient with unknown medical history, who experienced the unexpected serious (medically significant) events of insomnia and impaired work ability along other non serious events. The events occurred approximately 2 months after the second dose of Spikevax. Patient presented with vaccination site pain which impacted on his sleep ability, but this difficulty continued so he was prescribed multiple drugs for insomnia, trazondone, clonazepam, alprazolam, venlafaxine and eszopiclone. The event is ongoing (over a month) and resistant to these multiple drugs. This has impacted on his work ability. The rechallenge is not applicable. These events are considered medically significant based on duration, drug resistance and significant disability on work activities. The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-369151 (Patient Link).; Sender's Comments: This is Spontaneous case concerning a 64-year-old, male patient with unknown medical history, who experienced the unexpected serious (medically significant) events of insomnia and impaired work ability along other non serious events. The events occurred approximately 2 months after the second dose of Spikevax. Patient presented with vaccination site pain which impacted on his sleep ability, but this difficulty continued so he was prescribed multiple drugs for insomnia, trazondone, clonazepam, alprazolam, venlafaxine and eszopiclone. The event is ongoing (over a month) and resistant to these multiple drugs. This has impacted on his work ability. The rechallenge is not applicable. These events are considered medically significant based on duration, drug resistance and significant disability on work activities. The benefit-risk relationship of Spikevax is not affected by this report.