Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral, Tinnitus, White blood cell disorder
Clinical narrative: woke up on bathroom floor; lips tingling; soreness in the arm./painful; feel it (the arm) very heavy and hard to lift; had a tingling  on arms; had numbness on arms; ears ringing; patient said it was in a lot of pain; broke in a lot of sweat; felt very weak; fell; over all fatigue; head was pounding; white blood cells were immature; A spontaneous report was received from an 40-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced woke up on bathroom floor, lips tingling, soreness in the arm/painful, feel it (the arm) very heavy and hard to lift, had a tingling  on arms, had numbness on arms, ears ringing, patient said it was in a lot of pain, broke in a lot of sweat, felt very weak, white blood cells were immature, fell, over all fatigue and head was pounding.  The patient's medical history was not provided. Concomitant medications included: vitamin d nos and iron  On 04-MAR-2021, the patient received first of two planned doses of mRNA-1273 (lot/batch: 013A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   The patient reported that when she got the vaccine felt the lips tingling but thought it was psychologic. She felt soreness in the arm, but the major symptoms started within 6 hours of being vaccinated. She started to feel it (the arm) was very heavy and hard to lift. It was very painful and sore. Because of the pain and how heavy it was. Then the patient said it had a tingling and numbness on arms and hands. The patient said that progressively got worst and worst and that 8 hours after receiving the vaccine had to go to the restroom, sat on the toilet and turned to grab toilet paper and when turned back saw that already had the toilet paper. The patient said that Feel, like losing consciousness already. The patient also said she went to wash her hands and that's the last that she had remembered. The patient reported that she fell and woke up on the bathroom floor, her head was pounding, ears ringing, the patient said she was in a lot of pain, broke in a lot of sweat. The patient said that though "what if I like die because of the head".  The patient stated that around 12 hours after vaccination, she went to the urgent Care. On Urgent Care the caller said that they did an ECG, Blood, and urine test, and that the only thing they mentioned was that the white blood cells were immature. The patient said that when asked about it said that could be because has received the vaccine on the same morning. The patient said that she had a headache that lasted two days, 06-MAR-2021, the headache had gone away and came back in the afternoon, and on 07-MAR-2021 headache went away and returned at evening. The patient also said that felt very weak, and an overall fatigue after the first and second day. The patient has an appointment with the doctor 19-MAR-2021. The patient had not received any treatment and had taken Excedrin PM (Non steroid anti-inflammatory) just once before the vaccine. The adverse event of woke up on bathroom floor (loss of consciousness) was assessed as medically significant.  Action taken with mRNA-1273 in response to the events was not reported.  Outcome of the events of woke up on bathroom floor, lips tingling, soreness in the arm/painful, feel it (the arm) very heavy and hard to lift, had a tingling  on arms, had numbness on arms, ears ringing, patient said it was in a lot of pain, broke in a lot of sweat, felt very weak, white blood cells were immature, fell, over all fatigue and head was pounding was unknown.; Reporter's Comments: This case concerns a 40 Y/O F with serious unexpected loss of consciousness and nonserious unexpected paresthesia oral, pain in extremity, limb discomfort, paresthesia, hypoesthesia, tinnitus, pain, hyperhidrosis, asthenia white blood cell disorder, fall and expected headache, fatigue.  Event onset Day 1 of first dose of mRNA-1273. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.