Sex: U
Vaccine: COVID19
Symptoms: Ocular discomfort, Pain in extremity, Pain in jaw, Rash, Rhinorrhoea
Clinical narrative: Lymphocytic colitis; Massive Diarrhea; Ringing in ears periodically; Severe jaw pain; Familiar feeling rash appeared on my neck, rash; Knuckles swollen; Sweating; Congested; Bad hamstring muscle cramp/Toe cramp; very thirsty; joints still ache; Coughing attack; Swollen glands in neck; Eyes watering; neck pain, weird pulsing neck pangs, weird neck pain again; Passed out for an hr; Lower back and calves hurt; Confused about what day it is; Hands numb; Everything hurts; Lips feel dry and burn; Repitative sneezing; Can't keep eyes open; Very tired, sligh fatugue, periodic waves of fatigue; Arm started hurting, arm very sore to elbow, sharp pain in foot, toes hurt breifly, arm very painful, arm throbbing and painful; Hard to take deep breath, breathing labored; Snotty nose, blowing nose; Tightness in my chest; Foggy; Pain in left eye; Left ear hurt; Eyes itchy; Upset stomach; Tobacco taste again; Accompanied by headache, sharp back of headache; Slight nausea; Fingertips burn; Slightly dizzy; This spontaneous case was reported by a patient and describes the occurrence of COLITIS MICROSCOPIC (Lymphocytic colitis) and LOSS OF CONSCIOUSNESS (Passed out for an hr) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Feb-2021 at 12:38 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced CHEST DISCOMFORT (Tightness in my chest), DYSPNOEA (Hard to take deep breath, breathing labored), RHINORRHOEA (Snotty nose, blowing nose), FEELING ABNORMAL (Foggy), EYE PAIN (Pain in left eye), EAR PAIN (Left ear hurt), EYE PRURITUS (Eyes itchy), ABDOMINAL DISCOMFORT (Upset stomach), TASTE DISORDER (Tobacco taste again), BURNING SENSATION (Fingertips burn), DIZZINESS (Slightly dizzy), HEADACHE (Accompanied by headache, sharp back of headache) and NAUSEA (Slight nausea). On 08-Feb-2021 at 3:00 PM, the patient experienced PAIN IN EXTREMITY (Arm started hurting, arm very sore to elbow, sharp pain in foot, toes hurt breifly, arm very painful, arm throbbing and painful). On 08-Feb-2021 at 3:30 PM, the patient experienced FATIGUE (Very tired, sligh fatugue, periodic waves of fatigue). On 08-Feb-2021 at 4:45 PM, the patient experienced OCULAR DISCOMFORT (Can't keep eyes open). On 08-Feb-2021 at 8:10 PM, the patient experienced SNEEZING (Repitative sneezing). On 08-Feb-2021 at 8:30 PM, the patient experienced LIP DRY (Lips feel dry and burn). On 09-Feb-2021, the patient experienced CONFUSIONAL STATE (Confused about what day it is), HYPOAESTHESIA (Hands numb) and MYALGIA (Everything hurts). On 09-Feb-2021 at 11:00 AM, the patient experienced BACK PAIN (Lower back and calves hurt). On 09-Feb-2021 at 12:10 PM, the patient experienced LOSS OF CONSCIOUSNESS (Passed out for an hr) (seriousness criterion medically significant), LACRIMATION INCREASED (Eyes watering) and NECK PAIN (neck pain, weird pulsing neck pangs, weird neck pain again). On 09-Feb-2021 at 5:00 PM, the patient experienced LYMPHADENOPATHY (Swollen glands in neck). On 09-Feb-2021 at 11:00 PM, the patient experienced COUGH (Coughing attack). On 10-Feb-2021 at 7:50 AM, the patient experienced ARTHRALGIA (joints still ache). On 10-Feb-2021 at 3:00 PM, the patient experienced THIRST (very thirsty). On 11-Feb-2021, the patient experienced NASAL CONGESTION (Congested) and MUSCLE SPASMS (Bad hamstring muscle cramp/Toe cramp). On 11-Feb-2021 at 6:00 AM, the patient experienced HYPERHIDROSIS (Sweating). On 20-Feb-2021, the patient experienced SWELLING (Knuckles swollen). On 21-Feb-2021, the patient experienced PAIN IN JAW (Severe jaw pain) and RASH (Familiar feeling rash appeared on my neck, rash). In March 2021, the patient experienced TINNITUS (Ringing in ears periodically). On 23-Feb-2022, the patient experienced DIARRHOEA (Massive Diarrhea). On an unknown date, the patient experienced COLITIS MICROSCOPIC (Lymphocytic colitis) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. On 09-Feb-2021 at 1:10 PM, LOSS OF CONSCIOUSNESS (Passed out for an hr) had resolved. At the time of the report, COLITIS MICROSCOPIC (Lymphocytic colitis), FEELING ABNORMAL (Foggy), EYE PAIN (Pain in left eye), EAR PAIN (Left ear hurt), EYE PRURITUS (Eyes itchy), ABDOMINAL DISCOMFORT (Upset stomach), CONFUSIONAL STATE (Confused about what day it is), HYPERHIDROSIS (Sweating), PAIN IN JAW (Severe jaw pain), TINNITUS (Ringing in ears periodically), OCULAR DISCOMFORT (Can't keep eyes open), TASTE DISORDER (Tobacco taste again), SNEEZING (Repitative sneezing), LIP DRY (Lips feel dry and burn), BURNING SENSATION (Fingertips burn), THIRST (very thirsty), MUSCLE SPASMS (Bad hamstring muscle cramp/Toe cramp), SWELLING (Knuckles swollen), HYPOAESTHESIA (Hands numb) and MYALGIA (Everything hurts) outcome was unknown, CHEST DISCOMFORT (Tightness in my chest), PAIN IN EXTREMITY (Arm started hurting, arm very sore to elbow, sharp pain in foot, toes hurt breifly, arm very painful, arm throbbing and painful), DYSPNOEA (Hard to take deep breath, breathing labored), RHINORRHOEA (Snotty nose, blowing nose), BACK PAIN (Lower back and calves hurt), LACRIMATION INCREASED (Eyes watering), COUGH (Coughing attack), NASAL CONGESTION (Congested), NECK PAIN (neck pain, weird pulsing neck pangs, weird neck pain again), DIARRHOEA (Massive Diarrhea), DIZZINESS (Slightly dizzy), FATIGUE (Very tired, sligh fatugue, periodic waves of fatigue), HEADACHE (Accompanied by headache, sharp back of headache), LYMPHADENOPATHY (Swollen glands in neck), NAUSEA (Slight nausea) and ARTHRALGIA (joints still ache) had not resolved and RASH (Familiar feeling rash appeared on my neck, rash) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Body temperature: 97.5, 97.8 and 98.1. On 08-Feb-2021, Heart rate: Heart feels weird- abnormal. On 09-Feb-2021, Body temperature: 97.7, 98.4, 98.2, 99.2 and 98.2. On 10-Feb-2021, Body temperature: 97.7 and 97.7. On 11-Feb-2021, Body temperature: 96.8 and 97.5. No concomitant medications were reported. Patient was diagnosed with lymphocytic colitis and he/she reports that according to one study inherited autoimmune disease can be activated by mRNA shot number two. Patient under treatment of steroids. Patient had reactions from shot number two. Company Comment: This is a spontaneous case concerning a patient of unreported age and gender with no medical history reported, who experienced the unexpected serious (medically significant) events of Colitis microscopic and loss of consciousness, among other non-serious events. Patient reported that some hours after receiving the second dose of mRNA-1273 vaccine, he/she began with local and general reactions such as dizziness, nauseas followed by arm pain, dyspnea and headache, among other non-serious events. On the following day, had hands numbs, was confused, and pass out for one hour. Patient had fatigue and lymphadenopathy in neck. Due to a rash, was treated with Benadryl. One week after vaccination, patient had massive diarrhea and go on with other non-serious events. Additionally, one month after vaccination, patient developed tinnitus and on the following month, fatigue was still not resolved. Patient was treated with steroids for Colitis microscopic however, clinical course, investigations, diagnostic procedures, and other treatment received, were available in the report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a patient of unreported age and gender with no medical history reported, who experienced the unexpected serious (medically significant) events of Colitis microscopic and loss of consciousness, among other non-serious events. Patient reported that some hours after receiving the second dose of mRNA-1273 vaccine, he/she began with local and general reactions such as dizziness, nauseas followed by arm pain, dyspnea and headache, among other non-serious events. On the following day, had hands numbs, was confused, and pass out for one hour. Patient had fatigue and lymphadenopathy in neck. Due to a rash, was treated with Benadryl. One week after vaccination, patient had massive diarrhea and go on with other non-serious events. Additionally, one month after vaccination, patient developed tinnitus and on the following month, fatigue was still not resolved. Patient was treated with steroids for Colitis microscopic however, clinical course, investigations, diagnostic procedures, and other treatment received, were available in the report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.