Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia, Pyrexia, Tremor, Vomiting
Clinical narrative: Shaken; body tingle; numbness all over the body; very sick; Felt foggy; sore arm/aches; fever; vomiting; headache; nauseated; sensitive to light; aches; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOPHOBIA (sensitive to light), PAIN IN EXTREMITY (aches), PARAESTHESIA (body tingle), HYPOAESTHESIA (numbness all over the body) and ILLNESS (very sick) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OXYCODONE HYDROCHLORIDE (OXYCONTIN), LISINOPRIL, HYDROCHLOROTHIAZIDE, VORTIOXETINE HYDROBROMIDE (TRINTELLIX), PANTOPRAZOLE and ZOLPIDEM for an unknown indication.   On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced PHOTOPHOBIA (sensitive to light), PAIN IN EXTREMITY (aches), MYALGIA (sore arm/aches), PYREXIA (fever), VOMITING (vomiting), HEADACHE (headache) and NAUSEA (nauseated). On 14-Apr-2021, the patient experienced PARAESTHESIA (body tingle), HYPOAESTHESIA (numbness all over the body), ILLNESS (very sick) and FEELING ABNORMAL (Felt foggy). On an unknown date, the patient experienced TREMOR (Shaken). On 24-Mar-2021, VOMITING (vomiting) and NAUSEA (nauseated) had resolved. At the time of the report, PHOTOPHOBIA (sensitive to light), PAIN IN EXTREMITY (aches), PARAESTHESIA (body tingle), HYPOAESTHESIA (numbness all over the body), ILLNESS (very sick), FEELING ABNORMAL (Felt foggy), MYALGIA (sore arm/aches), PYREXIA (fever) and HEADACHE (headache) outcome was unknown and TREMOR (Shaken) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Blood potassium: low (Low) Low. On 14-Apr-2021, Blood pressure measurement: 180/103 (abnormal) 180/103.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided by the reporter.  Patient reported severe vomiting and numbness all over the body making her unable to move on 14th April 2021 after receiving the second dose on 13th Mar 2021. Patient reported vomiting, headache and sensitive to light along with sore arm, aches and fever on the evening after receiving the second dose on 13th Mar 2021. Patient mentioned as extremely nauseated and vomiting for one and half week. On contacting Primary care doctor, medication calmed down the vomiting but still felt nauseated after 30 days. On the evening of 14th Apr 2021. Patient mentioned that she felt foggy and couldn't wake up for 4 hours. She said that she is totally fine during the day. Patient felt tingling on the the body, numb and felt very very sick. On calling 911,Paramedics arrived and checked her blood pressure as 180/103 and her body is numb all over and cannot move. Numbness receded and Blood Pressure came down in a couple of hours. All the tests came out normal and said that Potassium was low and was discharged that night. Patient mentions as nauseated and shaken still at times.  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.; 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.