Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Insomnia, Loss of personal independence in daily activities, Nausea, Pain
Clinical narrative: Disable; Worried he is permanently disfigured; The pain is really bad; Cannot sleep; Rush; Joint pain; Headache; Nausea; Fatigue; Abdominal pain/right abdomen to his back felt like it was on fire, like he was being branded/fluttering in abdomen/incredible abdominal pain/abdominal pains are ongoing/severe abdominal pain/abdominal pains are ongoing; Urine was dark brown; A different stool color; Cannot go on long walks; Urine smelled like fish; Back Pain/ back right side pain/right abdomen to his back felt like it was on fire, like he was being branded; Life unlivable/  cannot continue with daily activities/For 18 days straight he cannot perform normal life functions; Been in pain for 29 days straight; Symptoms are severe because he cannot get out of bed; This spontaneous case was reported by a pharmacist and describes the occurrence of DISABILITY (Disable) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included ALPRAZOLAM (XANAX) for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain/right abdomen to his back felt like it was on fire, like he was being branded/fluttering in abdomen/incredible abdominal pain/abdominal pains are ongoing/severe abdominal pain/abdominal pains are ongoing), CHROMATURIA (Urine was dark brown), FAECES DISCOLOURED (A different stool color), GAIT DISTURBANCE (Cannot go on long walks), URINE ODOUR ABNORMAL (Urine smelled like fish), BACK PAIN (Back Pain/ back right side pain/right abdomen to his back felt like it was on fire, like he was being branded), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Life unlivable/  cannot continue with daily activities/For 18 days straight he cannot perform normal life functions), PAIN (Been in pain for 29 days straight), INSOMNIA (Cannot sleep), RASH (Rush), ARTHRALGIA (Joint pain), HEADACHE (Headache), NAUSEA (Nausea) and FATIGUE (Fatigue). In January 2021, the patient experienced BEDRIDDEN (Symptoms are severe because he cannot get out of bed). On 05-Feb-2021, the patient experienced PAIN (The pain is really bad). On 07-Feb-2021, the patient experienced DEFORMITY (Worried he is permanently disfigured). On an unknown date, the patient experienced DISABILITY (Disable) (seriousness criteria disability and medically significant). The patient was treated with HYOSCYAMINE SULFATE (LEVSIN) for Abdominal pain, at an unspecified dose and frequency and ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Abdominal pain, at an unspecified dose and frequency. In January 2021, CHROMATURIA (Urine was dark brown) and URINE ODOUR ABNORMAL (Urine smelled like fish) had resolved. At the time of the report, DISABILITY (Disable), ABDOMINAL PAIN (Abdominal pain/right abdomen to his back felt like it was on fire, like he was being branded/fluttering in abdomen/incredible abdominal pain/abdominal pains are ongoing/severe abdominal pain/abdominal pains are ongoing), BACK PAIN (Back Pain/ back right side pain/right abdomen to his back felt like it was on fire, like he was being branded), PAIN (The pain is really bad), DEFORMITY (Worried he is permanently disfigured), ARTHRALGIA (Joint pain), HEADACHE (Headache), NAUSEA (Nausea) and FATIGUE (Fatigue) had not resolved and FAECES DISCOLOURED (A different stool color), GAIT DISTURBANCE (Cannot go on long walks), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Life unlivable/  cannot continue with daily activities/For 18 days straight he cannot perform normal life functions), PAIN (Been in pain for 29 days straight), INSOMNIA (Cannot sleep), BEDRIDDEN (Symptoms are severe because he cannot get out of bed) and RASH (Rush) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient went to the imaging center for abdomen pain and awaiting for results. Patient experienced severe abdominal pain and after that he experienced anger.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. It is not clear if the disability is temporary or permanent. However, details including results of tests and diagnostics/ notes from HCP visit are required for further assessment.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2021: Follow up received on 25_JAN-2021, is significant. The  lab data, Concomitant(Xanax) and treatment(Levsin, Nexium) medication were  added, new events were updated. On 29-Jan-2021: The follow up received on 29-JAN-2021, is significant. Outcome of the events Back pain and Abdominal pain were updated from unknown to not recovered.Outcome of the event Chromaturia was updated from unknown to Recovered/Resolved. On 08-Feb-2021: Follow up received on 08-FEB-2021, is significant. The new event is added disfigurement. On 19-Apr-2021: Follow-up information received on 19-APR-2021 contains non-significant information On 05-May-2021: Follow up received on 05-MAY-2021, is significant. Event outcome was updated. On 19-Jun-2021: Follow up received on 19-JUN-2021 is significant.. New events were added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. It is not clear if the disability is temporary or permanent. However, details including results of tests and diagnostics/ notes from HCP visit are required for further assessment.