chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Inflammation, Vaccination site rash, Vaccination site warmth
Clinical narrative: the red inflammation was not smaller/grown in size/from shoulder down to elbow; the red inflammation was not smaller/grown in size/from shoulder down to elbow; late reaction: Rash on the Injection Site, the size of her hand; Injection Site is warm to the touch.; She was so tired and went to sleep; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (the red inflammation was not smaller/grown in size/from shoulder down to elbow), VACCINATION SITE WARMTH (Injection Site is warm to the touch.), ERYTHEMA (the red inflammation was not smaller/grown in size/from shoulder down to elbow), VACCINATION SITE RASH (late reaction: Rash on the Injection Site, the size of her hand) and FATIGUE (She was so tired and went to sleep) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-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 24-Feb-2021, the patient experienced FATIGUE (She was so tired and went to sleep). On 27-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Injection Site is warm to the touch.) and VACCINATION SITE RASH (late reaction: Rash on the Injection Site, the size of her hand). On 01-Mar-2021, the patient experienced INFLAMMATION (the red inflammation was not smaller/grown in size/from shoulder down to elbow) and ERYTHEMA (the red inflammation was not smaller/grown in size/from shoulder down to elbow). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination site pain, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Vaccination site pain, at a dose of 1 dosage form. At the time of the report, INFLAMMATION (the red inflammation was not smaller/grown in size/from shoulder down to elbow), VACCINATION SITE WARMTH (Injection Site is warm to the touch.), ERYTHEMA (the red inflammation was not smaller/grown in size/from shoulder down to elbow), VACCINATION SITE RASH (late reaction: Rash on the Injection Site, the size of her hand) and FATIGUE (She was so tired and went to sleep) outcome was unknown.            Treatment detail also included Cold Compress. No concomitant medications were provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2021: Follow up received and events added.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pyrexia
Clinical narrative: fever 102; headache; tiredness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever 102), HEADACHE (headache) and FATIGUE (tiredness) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02UM20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PYREXIA (fever 102), HEADACHE (headache) and FATIGUE (tiredness). At the time of the report, PYREXIA (fever 102), HEADACHE (headache) and FATIGUE (tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (Inconclusive) body temperature 102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medicines include tachycardia medication and  lungs medication treatment information was not provided   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever, chills
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Computerised tomogram head, Dizziness, Electrocardiogram, Headache
Clinical narrative: Headache, dizziness x 3 weeks
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test
Clinical narrative: Headache, dizziness x 3 weeks
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Asthenia, COVID-19, Cardiac failure congestive, Chronic kidney disease
Clinical narrative: Patient received COVID vaccine Moderna 2 dose series on 2/27/21 and 3/27/21. On 8/12/2, patient presented to our facility with SOB and weakness and was admitted to the inpatient unit for COVID 19 (hx of COPD) w/out hypoxia, CHF with fluid overload, and AKI on CKD3 with hyperkalemia. As of today (8/14), patient is still admitted in the med/surg unit.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Dyspnoea, Fluid overload, Hyperkalaemia, SARS-CoV-2 test positive
Clinical narrative: Patient received COVID vaccine Moderna 2 dose series on 2/27/21 and 3/27/21. On 8/12/2, patient presented to our facility with SOB and weakness and was admitted to the inpatient unit for COVID 19 (hx of COPD) w/out hypoxia, CHF with fluid overload, and AKI on CKD3 with hyperkalemia. As of today (8/14), patient is still admitted in the med/surg unit.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Pain in extremity, Paraesthesia
Clinical narrative: Starting 5 weeks after the second vaccine for covid, I began experiencing some mild nerve discomfort down my left arm, mostly from my elbow down through my pinky and ring finger on my left hand. Those two fingers would sometimes feel mildly tingly, almost numb. The most intense time of that feeling lasted for about 1-2 weeks, and then it slowly fade away until it was completely gone, I can't remember now exactly, but it lasted for about 8-12 weeks.  My right arm had a slight version (notably less) of some faint pain and numbness down my arm, and one faintly numb spot on my thumb. It started at the same time, but lasted only about a week. Because I experienced this in both arms, I'm not sure if it was related to the vaccine, because both my shots were in my left arm.  But I didn't have any other explanation for why this would suddenly happen.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Headache similar to headache when I had covid-19 in January 2021, nausea and dizziness that has persisted for the last 3 days with increasing severity.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19 pneumonia, Cerebrovascular accident, Condition aggravated, Hypoxia
Clinical narrative: Patient receive COVID vaccine Pfizer 2 dose series on 3/5/21 and 3/26/21. On 8/11/21, patient presented to our facility with 2 days history of fever and generalized weakness.  He was admitted for acute stroke with hypoxia due to COVID pneumonia. Patient discharged home on 8/13/21 in stable condition.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Patient receive COVID vaccine Pfizer 2 dose series on 3/5/21 and 3/26/21. On 8/11/21, patient presented to our facility with 2 days history of fever and generalized weakness.  He was admitted for acute stroke with hypoxia due to COVID pneumonia. Patient discharged home on 8/13/21 in stable condition.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: All over incessant itching, three weeks after first shot and continuing through second shot. Back stomach. Neck. Breasts, upper arms
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Chest pain, Dyspnoea
Clinical narrative: Chest pain and bloating in the chest area. The underwire in my bra was digging into me because my chest was  so swollen. The pain was in the front of my chest and under my ribs, but did not radiate to my back, just stayed in the front of my chest. It hurt to breathe in and I could barely move without being winded and extremely tired. My chest pain was a 6/10 on the pain scale and lasted for 4 hours before I took 1 Aleve. This was the worst chest pain I?ve ever felt. The pain went away an hour after I took the Aleve and seems to be gone now. I had my husband check my heart rate/rhythm during the event and he said it was normal.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Fatigue, Headache, Lymphadenopathy
Clinical narrative: 8/11/21 Received 1st dose of Moderna Covid shot 8/12/21 Woke up at 4am for work and heart was racing, left arm hurting. Heart rate continued 140 beats at rest for over an hour. Went to ER. Diagnosed with tachycardia and lactate 2.2.  I was seen by two emergency doctors (shift change) and both agreed it was possible symptom of the shot. Was given 2 bags of fluid. After receiving fluid my glands starting aching and had headache. Mid day at home had 101.1 fever. slept on and off rest of day. Drank fluids and switched between Tylenol and ibuprophen as instructed by ED doctors 8/13/21 Woke up at 2am with 102.6 fever, 120 heart rate, headache and aches. Again took tylenol, drank fluids. 8/14/21 Glands in neck are swollen, 99.5 low grade fever, headache, fatigue and just not feeling great. Tylenol and ibuprophen with drinking fluids.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Pain in extremity, Palpitations, Pyrexia
Clinical narrative: 8/11/21 Received 1st dose of Moderna Covid shot 8/12/21 Woke up at 4am for work and heart was racing, left arm hurting. Heart rate continued 140 beats at rest for over an hour. Went to ER. Diagnosed with tachycardia and lactate 2.2.  I was seen by two emergency doctors (shift change) and both agreed it was possible symptom of the shot. Was given 2 bags of fluid. After receiving fluid my glands starting aching and had headache. Mid day at home had 101.1 fever. slept on and off rest of day. Drank fluids and switched between Tylenol and ibuprophen as instructed by ED doctors 8/13/21 Woke up at 2am with 102.6 fever, 120 heart rate, headache and aches. Again took tylenol, drank fluids. 8/14/21 Glands in neck are swollen, 99.5 low grade fever, headache, fatigue and just not feeling great. Tylenol and ibuprophen with drinking fluids.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: 8/11/21 Received 1st dose of Moderna Covid shot 8/12/21 Woke up at 4am for work and heart was racing, left arm hurting. Heart rate continued 140 beats at rest for over an hour. Went to ER. Diagnosed with tachycardia and lactate 2.2.  I was seen by two emergency doctors (shift change) and both agreed it was possible symptom of the shot. Was given 2 bags of fluid. After receiving fluid my glands starting aching and had headache. Mid day at home had 101.1 fever. slept on and off rest of day. Drank fluids and switched between Tylenol and ibuprophen as instructed by ED doctors 8/13/21 Woke up at 2am with 102.6 fever, 120 heart rate, headache and aches. Again took tylenol, drank fluids. 8/14/21 Glands in neck are swollen, 99.5 low grade fever, headache, fatigue and just not feeling great. Tylenol and ibuprophen with drinking fluids.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Muscle spasms
Clinical narrative: 3 days after i started getting cramps in my chest. Strange pressure on occasions
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Headache
Clinical narrative: horrendous headaches; constipation; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (horrendous headaches) and CONSTIPATION (constipation) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included WARFARIN, CARVEDILOL, LOSARTAN, FUROSEMIDE, GABAPENTIN, LEVOTHYROXINE, POTASSIUM and LORATADINE for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced HEADACHE (horrendous headaches) and CONSTIPATION (constipation). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 01-Mar-2021, HEADACHE (horrendous headaches) had resolved. At the time of the report, CONSTIPATION (constipation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Pyrexia
Clinical narrative: Chest pain, difficulty breathing, persistent fever
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Confusional state, Dizziness, Dyspnoea, Syncope, Unresponsive to stimuli
Clinical narrative: Chest pain, difficulty breathing, persistent fever
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19 pneumonia, Pneumonia aspiration, SARS-CoV-2 test positive
Clinical narrative: Patient received COVID vaccine Pfizer 2 dose series on 3/2/21 and 3/25/21. On 8/10/21, patient was found down at home and admitted for COVID infection/pneumonia. Patient was also found to have probable superimposed bacterial aspiration pneumonia and acute respiratory failure with hypoxia. As of today (8/14/21), patient is still admitted in the med/surg unit.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Epistaxis, Heavy menstrual bleeding
Clinical narrative: Excessive menstrual crampng and significant menstrual blood for hours of pfizer injection  *concerned because IUD (mirena) has prevented24 menstrual cycles and spotting for 5+ years and within 24 hours of pfizer vaccine my menstrual cycle began along with a nose bleed
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray normal, Chronic respiratory failure, Hypoxia, Malaise
Clinical narrative: Patient received COVID vaccine Moderna series on 2/1/21 and 2/27/21. On 8/11/21, patient was admitted to our facility Hospital for COVID virus infection (mildly symptomatic, chest x-ray w/out signification findings of PNA), chronic respiratory failure with hypoxia (on home O2 therapy for COPD). Patient was discharged back to assisted living facility on 8/13/21 in good condition.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient received COVID vaccine Moderna series on 2/1/21 and 2/27/21. On 8/11/21, patient was admitted to our facility Hospital for COVID virus infection (mildly symptomatic, chest x-ray w/out signification findings of PNA), chronic respiratory failure with hypoxia (on home O2 therapy for COPD). Patient was discharged back to assisted living facility on 8/13/21 in good condition.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Cough, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: From 5/2 to about 7/5, I was triggered into asthma. I had to use my nebulizer 5-7 times/ day for 2 full months. I had a very bad cough. Usually my asthma is triggered either by allergies or by an infection. The two paths are different. This was as if I had an infection, but I didn't. It started 8 days after the 2nd shot. For the first week, before that, my arm where the shot was given to me was very swollen, hard as a rock, red, and very painful. Just as that was subsiding, my asthma was triggered out of the blue (unlike when I am having allergies -- that is a gradual tightening of my bronchial tubes that gives me some days to try to get ahead of it).
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Headache
Clinical narrative: Patient c/o sudden onset of headache to family and suddenly passed away immediately following statement made that she had a headache
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: blood sugar went up; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (blood sugar went up) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced BLOOD GLUCOSE INCREASED (blood sugar went up). The patient was treated with METFORMIN for Blood sugar increased, at a dose of 1 dosage form. At the time of the report, BLOOD GLUCOSE INCREASED (blood sugar went up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, Blood glucose: 340 (High) high. On an unknown date, Blood glucose: 100 (Inconclusive) usually in 100s.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  On 06-FEB-2021, the patient's blood sugar went up to 340 when it is usually was in the 100s. To treat this elevated blood sugar, his doctor doubled dose of metformin. Patient stated that doubling his dose of metformin had caused  to have diarrhea.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Hypertension
Clinical narrative: Abnormal high blood pressure (190/100) the morning following the injection. Addition aspirin was taken to thin my blood and this was successful. The addition aspirin is still required to main normal blood pressure.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Computerised tomogram
Clinical narrative: Short-term memory loss starting in the mid-morning and not subsiding. Sought help at local hospital.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: My menstrual cycle changed and was two weeks early. Since nothing else in my life has changed, the only reason for the menstrual change is a vaccine.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthritis, Eczema, Pruritus, Scab
Clinical narrative: Transient (1 month) Eczema Right small finger dorsal surface mid and distal phalanges - (crusting, pruritis, thickening of nailbed) Arthritis involving bilateral index & middle finger MCP and PIP joints starting at same time as Eczema over 1 month still present at time of this report
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Appetite disorder, Dizziness, Headache, Nausea
Clinical narrative: Dizziness began a few hours after the vaccine and hasn?t stopped since. On two separate days since vaccine, I?ve had severe headaches. On and off nausea and appetite tied to dizziness.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Balance disorder, Condition aggravated, Dizziness
Clinical narrative: The injection was extremely painful and bled which never happens to me. Within 2 days I was very tired and continued to be for several weeks.  The area where the shot was administered was and is sensitive.  My arm still aches from site down to my forearm. My elbow also aches. These aches are so severe I take Tylenol and sometimes a pain pill. Additionally it seems to have created severe arthritis in my right hand third, fourth and fifth fingers and thumb. Strangely the index finger doesn?t seem affected.  There is also a severe ache in my neck on the right side.  At times I also feel lightheaded and unsteady.  I have sometimes over the past thirty years had one sore in my genital area that I thought might be herpes, this has flared up twice and unlike previous times seems hard to cure with acyclovir.  My vision seems to have worsened somewhat as well.  I believe I am having an extreme ongoing auto immune response.  I am extremely healthy and usually feel very energetic  and great.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Genital blister, Injection site haemorrhage, Injection site hypersensitivity, Injection site pain
Clinical narrative: The injection was extremely painful and bled which never happens to me. Within 2 days I was very tired and continued to be for several weeks.  The area where the shot was administered was and is sensitive.  My arm still aches from site down to my forearm. My elbow also aches. These aches are so severe I take Tylenol and sometimes a pain pill. Additionally it seems to have created severe arthritis in my right hand third, fourth and fifth fingers and thumb. Strangely the index finger doesn?t seem affected.  There is also a severe ache in my neck on the right side.  At times I also feel lightheaded and unsteady.  I have sometimes over the past thirty years had one sore in my genital area that I thought might be herpes, this has flared up twice and unlike previous times seems hard to cure with acyclovir.  My vision seems to have worsened somewhat as well.  I believe I am having an extreme ongoing auto immune response.  I am extremely healthy and usually feel very energetic  and great.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Visual impairment
Clinical narrative: The injection was extremely painful and bled which never happens to me. Within 2 days I was very tired and continued to be for several weeks.  The area where the shot was administered was and is sensitive.  My arm still aches from site down to my forearm. My elbow also aches. These aches are so severe I take Tylenol and sometimes a pain pill. Additionally it seems to have created severe arthritis in my right hand third, fourth and fifth fingers and thumb. Strangely the index finger doesn?t seem affected.  There is also a severe ache in my neck on the right side.  At times I also feel lightheaded and unsteady.  I have sometimes over the past thirty years had one sore in my genital area that I thought might be herpes, this has flared up twice and unlike previous times seems hard to cure with acyclovir.  My vision seems to have worsened somewhat as well.  I believe I am having an extreme ongoing auto immune response.  I am extremely healthy and usually feel very energetic  and great.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Peripheral swelling
Clinical narrative: Feet and toes were swollen; Throbbing pain; Chills that was scary; This spontaneous case was reported by a physician and describes the occurrence of PERIPHERAL SWELLING (Feet and toes were swollen), PAIN (Throbbing pain) and CHILLS (Chills that was scary) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Feet and toes were swollen), PAIN (Throbbing pain) and CHILLS (Chills that was scary). The patient was treated with CEFALEXIN MONOHYDRATE (KEFLEX [CEFALEXIN MONOHYDRATE]) at a dose of 500 mg and NAPROXEN at a dose of 500 mg. At the time of the report, PERIPHERAL SWELLING (Feet and toes were swollen), PAIN (Throbbing pain) and CHILLS (Chills that was scary) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient took Keflex 500 mg four times a day for 10 days. Naproxen 500 mg twice a day for 5 days. Patient took Naproxen for 4 days , then stop the treatment because patient couldn't sleep and it seemed like it wasn't helping with swelling. Patient has one more day left for her Keflex. Concomitant medications were not reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cough, Dyspnoea, Dysstasia
Clinical narrative: Can not stand straight on her own; Feels like she have covid again; red knot on arm; Coughing real bad; Fever; Chills; Headache; Can't get out of bed; Hurting all over; Arm hurting; Dragging; Weak and can't move around; Shortness of breath; Can barely open her eyes; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Can't get out of bed), MYALGIA (Hurting all over), PAIN IN EXTREMITY (Arm hurting), VACCINATION COMPLICATION (Dragging) and ASTHENIA (Weak and can't move around) in a 57-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.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LETHARGY (Can't get out of bed), MYALGIA (Hurting all over), PAIN IN EXTREMITY (Arm hurting), VACCINATION COMPLICATION (Dragging), ASTHENIA (Weak and can't move around), DYSPNOEA (Shortness of breath), OCULAR DISCOMFORT (Can barely open her eyes), DYSSTASIA (Can not stand straight on her own), SUSPECTED COVID-19 (Feels like she have covid again), VACCINATION SITE MASS (red knot on arm), COUGH (Coughing real bad), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, LETHARGY (Can't get out of bed), MYALGIA (Hurting all over), PAIN IN EXTREMITY (Arm hurting), VACCINATION COMPLICATION (Dragging), ASTHENIA (Weak and can't move around), DYSPNOEA (Shortness of breath), OCULAR DISCOMFORT (Can barely open her eyes), DYSSTASIA (Can not stand straight on her own), SUSPECTED COVID-19 (Feels like she have covid again), VACCINATION SITE MASS (red knot on arm), COUGH (Coughing real bad), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Myalgia, Ocular discomfort, Pain in extremity
Clinical narrative: Can not stand straight on her own; Feels like she have covid again; red knot on arm; Coughing real bad; Fever; Chills; Headache; Can't get out of bed; Hurting all over; Arm hurting; Dragging; Weak and can't move around; Shortness of breath; Can barely open her eyes; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Can't get out of bed), MYALGIA (Hurting all over), PAIN IN EXTREMITY (Arm hurting), VACCINATION COMPLICATION (Dragging) and ASTHENIA (Weak and can't move around) in a 57-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.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LETHARGY (Can't get out of bed), MYALGIA (Hurting all over), PAIN IN EXTREMITY (Arm hurting), VACCINATION COMPLICATION (Dragging), ASTHENIA (Weak and can't move around), DYSPNOEA (Shortness of breath), OCULAR DISCOMFORT (Can barely open her eyes), DYSSTASIA (Can not stand straight on her own), SUSPECTED COVID-19 (Feels like she have covid again), VACCINATION SITE MASS (red knot on arm), COUGH (Coughing real bad), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, LETHARGY (Can't get out of bed), MYALGIA (Hurting all over), PAIN IN EXTREMITY (Arm hurting), VACCINATION COMPLICATION (Dragging), ASTHENIA (Weak and can't move around), DYSPNOEA (Shortness of breath), OCULAR DISCOMFORT (Can barely open her eyes), DYSSTASIA (Can not stand straight on her own), SUSPECTED COVID-19 (Feels like she have covid again), VACCINATION SITE MASS (red knot on arm), COUGH (Coughing real bad), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Suspected COVID-19, Vaccination complication, Vaccination site mass
Clinical narrative: Can not stand straight on her own; Feels like she have covid again; red knot on arm; Coughing real bad; Fever; Chills; Headache; Can't get out of bed; Hurting all over; Arm hurting; Dragging; Weak and can't move around; Shortness of breath; Can barely open her eyes; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Can't get out of bed), MYALGIA (Hurting all over), PAIN IN EXTREMITY (Arm hurting), VACCINATION COMPLICATION (Dragging) and ASTHENIA (Weak and can't move around) in a 57-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.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LETHARGY (Can't get out of bed), MYALGIA (Hurting all over), PAIN IN EXTREMITY (Arm hurting), VACCINATION COMPLICATION (Dragging), ASTHENIA (Weak and can't move around), DYSPNOEA (Shortness of breath), OCULAR DISCOMFORT (Can barely open her eyes), DYSSTASIA (Can not stand straight on her own), SUSPECTED COVID-19 (Feels like she have covid again), VACCINATION SITE MASS (red knot on arm), COUGH (Coughing real bad), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, LETHARGY (Can't get out of bed), MYALGIA (Hurting all over), PAIN IN EXTREMITY (Arm hurting), VACCINATION COMPLICATION (Dragging), ASTHENIA (Weak and can't move around), DYSPNOEA (Shortness of breath), OCULAR DISCOMFORT (Can barely open her eyes), DYSSTASIA (Can not stand straight on her own), SUSPECTED COVID-19 (Feels like she have covid again), VACCINATION SITE MASS (red knot on arm), COUGH (Coughing real bad), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymph node pain, Pain in extremity
Clinical narrative: Headache; achenes in arm and legs; some tenderness in lymph node; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PAIN IN EXTREMITY (achenes in arm and legs) and LYMPH NODE PAIN (some tenderness in lymph node) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included Fall and Ministroke (In November.).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced HEADACHE (Headache), PAIN IN EXTREMITY (achenes in arm and legs) and LYMPH NODE PAIN (some tenderness in lymph node). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 325 mg. At the time of the report, HEADACHE (Headache), PAIN IN EXTREMITY (achenes in arm and legs) and LYMPH NODE PAIN (some tenderness in lymph node) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Product dose omission issue
Clinical narrative: She developed the Shingle infection after the first dose; Patient did not get the second dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (She developed the Shingle infection after the first dose) and PRODUCT DOSE OMISSION ISSUE (Patient did not get the second dose of vaccine) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (She developed the Shingle infection after the first dose) and PRODUCT DOSE OMISSION ISSUE (Patient did not get the second dose of vaccine). At the time of the report, HERPES ZOSTER (She developed the Shingle infection after the first dose) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient did not get the second dose of vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Patient used ointment for Shingle infection.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema of eyelid, Swelling of eyelid
Clinical narrative: swelling upper eyelids; redness to the upper eyelids; This spontaneous case was reported by an other health care professional and describes the occurrence of SWELLING OF EYELID (swelling upper eyelids) and ERYTHEMA OF EYELID (redness to the upper eyelids) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included POLY-L-LACTIC ACID (SCULPTRA AESTHETIC) from 04-Feb-2021 to an unknown date for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced SWELLING OF EYELID (swelling upper eyelids) and ERYTHEMA OF EYELID (redness to the upper eyelids). The patient was treated with PREDNISONE at a dose of 1 dosage form. At the time of the report, SWELLING OF EYELID (swelling upper eyelids) and ERYTHEMA OF EYELID (redness to the upper eyelids) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Chest discomfort, Feeling abnormal, Headache, Oropharyngeal discomfort
Clinical narrative: this morning, I don't feel good; feeling a tightness of the throat and chest; feeling a tightness of the throat and chest; feels like having an asthma attack; headache; Injection site is hard and hot to touch; Injection site is hard and hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (feels like having an asthma attack), VACCINATION SITE WARMTH (Injection site is hard and hot to touch), FEELING ABNORMAL (this morning, I don't feel good), OROPHARYNGEAL DISCOMFORT (feeling a tightness of the throat and chest) and CHEST DISCOMFORT (feeling a tightness of the throat and chest) in a 75-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.     No medical history was provided.  Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR HFA), SALBUTAMOL (ALBUTEROL HFA), METOPROLOL, ATORVASTATIN, COLECALCIFEROL (VIT D [COLECALCIFEROL]), LORATADINE (CLARITIN [LORATADINE]), CYANOCOBALAMIN (VIT B 12), TIMOLOL and LATANOPROST for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Injection site is hard and hot to touch) and VACCINATION SITE INDURATION (Injection site is hard and hot to touch). On 27-Feb-2021, the patient experienced ASTHMA (feels like having an asthma attack), FEELING ABNORMAL (this morning, I don't feel good), OROPHARYNGEAL DISCOMFORT (feeling a tightness of the throat and chest), CHEST DISCOMFORT (feeling a tightness of the throat and chest) and HEADACHE (headache). At the time of the report, ASTHMA (feels like having an asthma attack), VACCINATION SITE WARMTH (Injection site is hard and hot to touch), FEELING ABNORMAL (this morning, I don't feel good), OROPHARYNGEAL DISCOMFORT (feeling a tightness of the throat and chest), CHEST DISCOMFORT (feeling a tightness of the throat and chest), VACCINATION SITE INDURATION (Injection site is hard and hot to touch) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment medication was provided by the reporter. Patient had recovered after 1 week. Patient's allergist had suggested her to take some inhalers before taking 2nd shot,  which she did.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Outcome of the adverse event added
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site warmth
Clinical narrative: this morning, I don't feel good; feeling a tightness of the throat and chest; feeling a tightness of the throat and chest; feels like having an asthma attack; headache; Injection site is hard and hot to touch; Injection site is hard and hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (feels like having an asthma attack), VACCINATION SITE WARMTH (Injection site is hard and hot to touch), FEELING ABNORMAL (this morning, I don't feel good), OROPHARYNGEAL DISCOMFORT (feeling a tightness of the throat and chest) and CHEST DISCOMFORT (feeling a tightness of the throat and chest) in a 75-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.     No medical history was provided.  Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR HFA), SALBUTAMOL (ALBUTEROL HFA), METOPROLOL, ATORVASTATIN, COLECALCIFEROL (VIT D [COLECALCIFEROL]), LORATADINE (CLARITIN [LORATADINE]), CYANOCOBALAMIN (VIT B 12), TIMOLOL and LATANOPROST for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Injection site is hard and hot to touch) and VACCINATION SITE INDURATION (Injection site is hard and hot to touch). On 27-Feb-2021, the patient experienced ASTHMA (feels like having an asthma attack), FEELING ABNORMAL (this morning, I don't feel good), OROPHARYNGEAL DISCOMFORT (feeling a tightness of the throat and chest), CHEST DISCOMFORT (feeling a tightness of the throat and chest) and HEADACHE (headache). At the time of the report, ASTHMA (feels like having an asthma attack), VACCINATION SITE WARMTH (Injection site is hard and hot to touch), FEELING ABNORMAL (this morning, I don't feel good), OROPHARYNGEAL DISCOMFORT (feeling a tightness of the throat and chest), CHEST DISCOMFORT (feeling a tightness of the throat and chest), VACCINATION SITE INDURATION (Injection site is hard and hot to touch) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment medication was provided by the reporter. Patient had recovered after 1 week. Patient's allergist had suggested her to take some inhalers before taking 2nd shot,  which she did.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Outcome of the adverse event added
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Pink swollen area on my left Upper arm; Vaccination site warmth; It would be itchy; Red area around the injection site about 4x4; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Pink swollen area on my left Upper arm), VACCINATION SITE WARMTH (Vaccination site warmth), PRURITUS (It would be itchy) and VACCINATION SITE ERYTHEMA (Red area around the injection site about 4x4) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high since 1987. Concomitant products included HCTZ and LOSARTAN POTASSIUM (LOSATAN) for Blood pressure high, CALCIUM CITRATE, COLECALCIFEROL (CITRACAL + D [CALCIUM CITRATE;COLECALCIFEROL]) for Bone loss, POTASSIUM for Potassium deficiency, PRAVASTATIN SODIUM, CARVEDILOL, IRON, AMLODIPINE and CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;IODINE;IRON;LYCOPENE;MAGNESIUM;MANGANESE;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PERIPHERAL SWELLING (Pink swollen area on my left Upper arm), VACCINATION SITE WARMTH (Vaccination site warmth) and VACCINATION SITE ERYTHEMA (Red area around the injection site about 4x4). On an unknown date, the patient experienced PRURITUS (It would be itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Pink swollen area on my left Upper arm), VACCINATION SITE WARMTH (Vaccination site warmth), PRURITUS (It would be itchy) and VACCINATION SITE ERYTHEMA (Red area around the injection site about 4x4) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: NNI On 06-May-2021: Patient demographics were added. New events pink swollen area on left upper arm, itchy were added.  Concomitant product information was added. On 15-Jun-2021: MSA notes were added.
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Fatigue, Headache, Heart rate increased, Pyrexia
Clinical narrative: experiencing some rapid heartbeat; tightness in the muscle in upper right chest/discomfort in the chest on the right side; headache; tiredness; slight fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (experiencing some rapid heartbeat), CHEST DISCOMFORT (tightness in the muscle in upper right chest/discomfort in the chest on the right side), HEADACHE (headache), FATIGUE (tiredness) and PYREXIA (slight fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (experiencing some rapid heartbeat), CHEST DISCOMFORT (tightness in the muscle in upper right chest/discomfort in the chest on the right side), HEADACHE (headache), FATIGUE (tiredness) and PYREXIA (slight fever). At the time of the report, HEART RATE INCREASED (experiencing some rapid heartbeat), CHEST DISCOMFORT (tightness in the muscle in upper right chest/discomfort in the chest on the right side), HEADACHE (headache), FATIGUE (tiredness) and PYREXIA (slight fever) outcome was unknown.            Patient treatment information was not provided. Concomitant medication information was not provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Visual impairment
Clinical narrative: vision was shaky, unsteady and is progressing worse; headache; This spontaneous case was reported by a physician and describes the occurrence of VISUAL IMPAIRMENT (vision was shaky, unsteady and is progressing worse) and HEADACHE (headache) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VISUAL IMPAIRMENT (vision was shaky, unsteady and is progressing worse) and HEADACHE (headache). At the time of the report, VISUAL IMPAIRMENT (vision was shaky, unsteady and is progressing worse) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment information was not reported.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose decreased, Hypersensitivity, Myalgia, Vaccination site erythema, Vaccination site warmth
Clinical narrative: covid arm; hot; blood sugar level is always low said that it went down to 40 which his usual is from 70-80(Patient is diabetic); Arm soreness; red; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (covid arm), VACCINATION SITE WARMTH (hot), BLOOD GLUCOSE DECREASED (blood sugar level is always low said that it went down to 40 which his usual is from 70-80(Patient is diabetic)), MYALGIA (Arm soreness) and VACCINATION SITE ERYTHEMA (red) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]), CANAGLIFLOZIN (INVOKANA [CANAGLIFLOZIN]) and METFORMIN for an unknown indication.   On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 22-Feb-2021, the patient experienced HYPERSENSITIVITY (covid arm), VACCINATION SITE WARMTH (hot), BLOOD GLUCOSE DECREASED (blood sugar level is always low said that it went down to 40 which his usual is from 70-80(Patient is diabetic)), MYALGIA (Arm soreness) and VACCINATION SITE ERYTHEMA (red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Pain in arm, at a dose of 1 dosage form. At the time of the report, HYPERSENSITIVITY (covid arm), VACCINATION SITE WARMTH (hot), BLOOD GLUCOSE DECREASED (blood sugar level is always low said that it went down to 40 which his usual is from 70-80(Patient is diabetic)), MYALGIA (Arm soreness) and VACCINATION SITE ERYTHEMA (red) outcome was unknown.            Patient took Benadryl for sore arm and diabetic medications.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Vaccine leaked out on my arm; Vaccine leaked out on her arm; A spontaneous report was received from a consumer concerning a 58 year old, female patient who experienced vaccine under dose and device connection issues.   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.  On 25-FEB-2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number:031M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    Patient stated vaccine leaked out of the syringe while it was being administered. The person administering the vaccine admitted to not properly attaching the needle. The administrator offered a second dose, but the patient refused.    Treatment information was not provided.    Action taken with mRNA-1273 in response to the event(s) was not provided.  The event(s), vaccine under dose and device connection issues, were considered resolved/recovered on 25-FEB-2021.; Reporter's Comments: This report refers to a case of underdose and device connection issue for mRNA-1273 (lot # 031M20A) with no associated AEs reported.