Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vasodilatation
Clinical narrative: didn't feel right; period only lasted two days; started getting sicker and sicker; heart palpitations; Pott's disease flaring up; Neuropathy got worse; Neuropathy got worse; her body amounted a huge immune response to the vaccine; feels like she is super hungover; feels like she is severely dehydrated; feels like she is going to collapse or faint at any time; period was late; felt like cells were spiking or flipping out; bad migraine; headache; fever; slight microscopic tremble over her body, specifically in her hands, face and around her mouth; had another horrible wave of inflammation; shivery; can't funciton like a normal person; felt like she was going to drop dead/feels like she is going to die/feels like her life has come to a halt; worst autoimmune flare up in her entire life; worst autoimmune flare up in her entire life; anytime she would drift to sleep, she would jolt awake/was not getting sleep; could barely walk; tremors all over her body/felt like her cells were spiking or flipping out/shaky and trembling; hit the wall of the worst she ever felt/felt very odd and horrid; couldn't breathe right; veins in her hand were bulging like a weight lifter and they hurt very bad; veins in her hand were bulging like a weight lifter and they hurt very bad; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of BONE TUBERCULOSIS (Pott's disease flaring up), NEUROPATHY PERIPHERAL (Neuropathy got worse), AUTOIMMUNE DISORDER (worst autoimmune flare up in her entire life), CONDITION AGGRAVATED (Neuropathy got worse) and CONDITION AGGRAVATED (worst autoimmune flare up in her entire life) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Gabapentin (hasn't taken in months). Past adverse reactions to the above products included No adverse event with Gabapentin. Concurrent medical conditions included Autoimmune disorder NOS (many autoimmune conditions which have been treated), Sciatica, Neuropathy (under control) and Palpitations (under control). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ALPRAZOLAM and VITAMINS NOS for an unknown indication.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced AUTOIMMUNE DISORDER (worst autoimmune flare up in her entire life), CONDITION AGGRAVATED (worst autoimmune flare up in her entire life) and TREMOR (tremors all over her body/felt like her cells were spiking or flipping out/shaky and trembling). 08-May-2021, the patient experienced INSOMNIA (anytime she would drift to sleep, she would jolt awake/was not getting sleep), GAIT DISTURBANCE (could barely walk), FEELING ABNORMAL (hit the wall of the worst she ever felt/felt very odd and horrid), DYSPNOEA (couldn't breathe right), MALAISE (felt like she was going to drop dead/feels like she is going to die/feels like her life has come to a halt), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (can't funciton like a normal person) and CHILLS (shivery). In May 2021, the patient experienced VASODILATATION (veins in her hand were bulging like a weight lifter and they hurt very bad) and VASCULAR PAIN (veins in her hand were bulging like a weight lifter and they hurt very bad). On 01-Jun-2021, the patient experienced INFLAMMATION (had another horrible wave of inflammation) and TREMOR (slight microscopic tremble over her body, specifically in her hands, face and around her mouth). On an unknown date, the patient experienced BONE TUBERCULOSIS (Pott's disease flaring up), NEUROPATHY PERIPHERAL (Neuropathy got worse), CONDITION AGGRAVATED (Neuropathy got worse), FEELING ABNORMAL (didn't feel right), HYPOMENORRHOEA (period only lasted two days), ILLNESS (started getting sicker and sicker), PALPITATIONS (heart palpitations), VACCINATION COMPLICATION (her body amounted a huge immune response to the vaccine), HANGOVER (feels like she is super hungover), DEHYDRATION (feels like she is severely dehydrated), DIZZINESS (feels like she is going to collapse or faint at any time), MENSTRUATION DELAYED (period was late), FEELING ABNORMAL (felt like cells were spiking or flipping out), MIGRAINE (bad migraine), HEADACHE (headache) and PYREXIA (fever). At the time of the report, BONE TUBERCULOSIS (Pott's disease flaring up), NEUROPATHY PERIPHERAL (Neuropathy got worse), AUTOIMMUNE DISORDER (worst autoimmune flare up in her entire life), CONDITION AGGRAVATED (Neuropathy got worse), CONDITION AGGRAVATED (worst autoimmune flare up in her entire life), FEELING ABNORMAL (didn't feel right), ILLNESS (started getting sicker and sicker), PALPITATIONS (heart palpitations), INSOMNIA (anytime she would drift to sleep, she would jolt awake/was not getting sleep), GAIT DISTURBANCE (could barely walk), FEELING ABNORMAL (hit the wall of the worst she ever felt/felt very odd and horrid), DYSPNOEA (couldn't breathe right), VACCINATION COMPLICATION (her body amounted a huge immune response to the vaccine), VASODILATATION (veins in her hand were bulging like a weight lifter and they hurt very bad), VASCULAR PAIN (veins in her hand were bulging like a weight lifter and they hurt very bad), INFLAMMATION (had another horrible wave of inflammation), HANGOVER (feels like she is super hungover), DEHYDRATION (feels like she is severely dehydrated), MALAISE (felt like she was going to drop dead/feels like she is going to die/feels like her life has come to a halt), DIZZINESS (feels like she is going to collapse or faint at any time), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (can't funciton like a normal person), TREMOR (slight microscopic tremble over her body, specifically in her hands, face and around her mouth), CHILLS (shivery), HEADACHE (headache) and PYREXIA (fever) had not resolved, HYPOMENORRHOEA (period only lasted two days), MENSTRUATION DELAYED (period was late), FEELING ABNORMAL (felt like cells were spiking or flipping out) and MIGRAINE (bad migraine) outcome was unknown and TREMOR (tremors all over her body/felt like her cells were spiking or flipping out/shaky and trembling) had resolved.            After the patient's second dose, she didn't feel right; it was much worse than the first. She started getting sicker and sicker and her Pott's disease flared up. Two weeks to the day of her second dose, she hit the wall of the worst she ever felt; felt like she was going to drop dead. She went to the emergency room (ER). She could feel all her organs and feel the adrenaline coursing through her body. She felt like laying down but couldn't breathe right. She felt like she was being pushed down at all times. She could barely walk, was shivery, shaky and trembling. It was the worst autoimmune flare up in her entire life. The ER didn't really know what was wrong and thought maybe it was because her levothyroxine (SYNTHROID) had been adjusted. She felt a little better a few days later but the veins in her hand were bulging like a weight lifter and hurt very bad. She followed up with her doctor 6 weeks after her first dose. The patient reported it was still hitting hard and she couldn't function like a normal person. Her period was late and her body went haywire. Treatment information was not reported.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-201484 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.