Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Gastrointestinal bacterial overgrowth, Hair growth rate abnormal, Lyme disease, Myocarditis
Clinical narrative: decrease in blood pressure; hair grew incredibly fast; nails grew incredibly fast; flare of lyme's disease, lyme's disease flare up/neurological signs/Sensitivity to heat on the body/losing movement at the site; Small intestine tract bacteria over growth; waist size increased; non-serious weird signs of body growing/became 4 inches taller; myocarditis; neurological symptoms had spread to the circulatory system; inability to process stress; inability to process emotions; flare of lyme's disease,lyme's disease flare up/brain injury/not fully gone through puberty/pain and internal organs moved with humira/feeling of soda bubbles moving up and down in spine/loss of movement/losing sensation at the site/loss of sensati; very worn down for about three days after each shot; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL BACTERIAL OVERGROWTH (Small intestine tract bacteria over growth), STRESS (inability to process stress), LYME DISEASE (flare of lyme's disease,lyme's disease flare up/brain injury/not fully gone through puberty/pain and internal organs moved with humira/feeling of soda bubbles moving up and down in spine/loss of movement/losing sensation at the site/loss of sensation), LYME DISEASE (flare of lyme's disease, lyme's disease flare up/neurological signs/Sensitivity to heat on the body/losing movement at the site), EMOTIONAL DISORDER (inability to process emotions), BLOOD PRESSURE DECREASED (decrease in blood pressure), NEUROLOGICAL SYMPTOM (neurological symptoms had spread to the circulatory system), WAIST CIRCUMFERENCE INCREASED (waist size increased) and MYOCARDITIS (myocarditis) in a 28-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Lyme's disease (The patient's wife reported that patient had Lyme's disease since he was a child.).   In June 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In November 2020, the patient experienced LYME DISEASE (flare of lyme's disease,lyme's disease flare up/brain injury/not fully gone through puberty/pain and internal organs moved with humira/feeling of soda bubbles moving up and down in spine/loss of movement/losing sensation at the site/loss of sensation) (seriousness criterion medically significant). In February 2021, the patient experienced STRESS (inability to process stress) (seriousness criterion medically significant), EMOTIONAL DISORDER (inability to process emotions) (seriousness criterion medically significant), NEUROLOGICAL SYMPTOM (neurological symptoms had spread to the circulatory system) (seriousness criterion medically significant) and MYOCARDITIS (myocarditis) (seriousness criterion medically significant). In March 2021, the patient experienced GASTROINTESTINAL BACTERIAL OVERGROWTH (Small intestine tract bacteria over growth) (seriousness criterion medically significant), WAIST CIRCUMFERENCE INCREASED (waist size increased) (seriousness criterion medically significant) and BODY HEIGHT INCREASED (non-serious weird signs of body growing/became 4 inches taller). In May 2022, the patient experienced LYME DISEASE (flare of lyme's disease, lyme's disease flare up/neurological signs/Sensitivity to heat on the body/losing movement at the site) (seriousness criterion medically significant). On an unknown date, the patient experienced BLOOD PRESSURE DECREASED (decrease in blood pressure) (seriousness criterion medically significant), HAIR GROWTH RATE ABNORMAL (hair grew incredibly fast), NAIL GROWTH ABNORMAL (nails grew incredibly fast) and FATIGUE (very worn down for about three days after each shot). At the time of the report, GASTROINTESTINAL BACTERIAL OVERGROWTH (Small intestine tract bacteria over growth), STRESS (inability to process stress), LYME DISEASE (flare of lyme's disease,lyme's disease flare up/brain injury/not fully gone through puberty/pain and internal organs moved with humira/feeling of soda bubbles moving up and down in spine/loss of movement/losing sensation at the site/loss of sensation), LYME DISEASE (flare of lyme's disease, lyme's disease flare up/neurological signs/Sensitivity to heat on the body/losing movement at the site), EMOTIONAL DISORDER (inability to process emotions), BLOOD PRESSURE DECREASED (decrease in blood pressure), NEUROLOGICAL SYMPTOM (neurological symptoms had spread to the circulatory system), WAIST CIRCUMFERENCE INCREASED (waist size increased), MYOCARDITIS (myocarditis), HAIR GROWTH RATE ABNORMAL (hair grew incredibly fast), NAIL GROWTH ABNORMAL (nails grew incredibly fast), BODY HEIGHT INCREASED (non-serious weird signs of body growing/became 4 inches taller) and FATIGUE (very worn down for about three days after each shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body height: increased. In March 2021, Waist circumference: increased. On an unknown date, Blood pressure measurement: decreased.     mRNA-1273 (Spikevax) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.  In Jun 2020 the patient started taking HUMIRA and at that time the Lyme's disease was dormant. That particular type of Lyme's disease acted like a brain injury and caused him to not fully gone through puberty. He experienced other symptoms like joint pain, popping joints and the feeling of soda bubbles moving up and down his spine. In Mar 2021, patient started intravenous antibiotic therapy via a Peripherally inserted central catheter line, which was lasted for six weeks. At week four during his treatment, weird signs of his body started to grow. It was like he was going or finishing going through puberty. In May 2022, patient also developed pain in his joints.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality and manufacturer's opinion for the events of sensitivity to heat on the body, losing movement at the site, feeling of soda bubbles moving up and down in spine, losing sensation at the site, small intestine tract bacteria over growth, weird signs of body growing/became 4 inches taller, waist size increased, bed ridden, brain injury, not fully gone through puberty, loss of movement, neurological signs, hair grew incredibly fast, myocarditis, decrease in blood pressure, nails grew incredibly fast, inability to process stress, flare up/of lyme's disease, loss of sensation, inability to process emotions, was reasonable possibility and no reasonable possibility, respectively. The reporter's causality for pain and internal organs moved with humira was a reasonable possibility and for worn down, neurological symptoms had spread to the circulatory system, toe where rash on feet, toe where swelling on feet and COVID was not provided.  Manufacturer's opinion was that there was no reasonable possibility that the events of toe  where swelling on feet, COVID and pain are related to humira. The event of internal organs moved was not assessable.  Company comment: This is a Spontaneous case reported by a consumer, concerning a 28-year-old male patient, with relevant concurrent conditions of Lyme´s disease and Crohn´s disease in treatment with Adalimumab since June 2020 (reported as a suspect drug). Patient has received both primary COVID-19 vaccination and booster dose with mRNA-1273 vaccine, on unknown dates. In June 2020, Lyme´s disease was dormant. 5 months later symptoms started to flare. He was experiencing increased brain fog, difficulty to focus, cold temperature caused pain, heat on his body caused him loss of sensation or movement, joint pain, felling of soda bubbles moving up and down his spine. In February 2021, patient had become fully bedridden due to his symptoms. He experienced a decrease in blood pressure, myocarditis, and the inability to process stress or emotions. In March 2021, patient started intravenous antibiotic therapy. This lasted for 6 weeks. At week 4, he became 4 inches taller, his waist size increased, his internal organs moved, and his hair and nails grew incredibly fast. Patient also experienced a small intestine tract bacteria overgrowth. In May 2022, patient started to develop signs of his Lyme´s disease again with neurological signs, pain in his joints and sensitivity to heat. No information disclosed about diagnostic tests performed, clinical course or other treatments received. Since vaccination dates were not provided, temporal association and latency cannot be properly assessed. Lyme´s disease can present relapses as part of the natural history of disease, so that confounds the case. Crohn´s disease could also be a confounder for the case. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-616834, MOD-2022-616833 (Patient Link).; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a 28-year-old male patient, with relevant concurrent conditions of Lyme´s disease and Crohn´s disease in treatment with Adalimumab since June 2020 (reported as a suspect drug). Patient has received both primary COVID-19 vaccination and booster dose with mRNA-1273 vaccine, on unknown dates. In June 2020, Lyme´s disease was dormant. 5 months later symptoms started to flare. He was experiencing increased brain fog, difficulty to focus, cold temperature caused pain, heat on his body caused him loss of sensation or movement, joint pain, felling of soda bubbles moving up and down his spine. In February 2021, patient had become fully bedridden due to his symptoms. He experienced a decrease in blood pressure, myocarditis, and the inability to process stress or emotions. In March 2021, patient started intravenous antibiotic therapy. This lasted for 6 weeks. At week 4, he became 4 inches taller, his waist size increased, his internal organs moved, and his hair and nails grew incredibly fast. Patient also experienced a small intestine tract bacteria overgrowth. In May 2022, patient started to develop signs of his Lyme´s disease again with neurological signs, pain in his joints and sensitivity to heat. No information disclosed about diagnostic tests performed, clinical course or other treatments received. Since vaccination dates were not provided, temporal association and latency cannot be properly assessed. Lyme´s disease can present relapses as part of the natural history of disease, so that confounds the case. Crohn´s disease could also be a confounder for the case. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.