chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Product storage error
Clinical narrative: Vaccine vial was punctured on Friday 11/18/22 at approximately 10am and 6 doses drawn up into syringes. These syringes were stored at room temperature. Dose administered to the patient on 11/21/22 was from a syringe that had been drawn up on Friday 11/18 and stored at room temp.  Pfizer contacted for stability information, which they did not have for these storage conditions. Patient is being contacted for re-vaccination.
Age: 68.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: I tested positive for Covid about 5 weeks after my bivalent booster
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Influenza, Influenza A virus test negative, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Patient  was administered vaccine on left thigh on Monday, November 21st. The condition of the patient at the time was normal, did not have any illnesses nor medical conditions (i.e. no cough, fever, no rashes, nor any ailments). The following day (November 22nd), in the morning when the patient woke up, while I (parent) was changing him, I noticed the injection site to be enlarged, swollen, and red (roughly around 3 inches in diameter). That evening, patient felt warm. The following morning (November 23rd), the injection site was even larger, more red, and swollen (roughy around 4 inches in diameter) and was accompanied by a fever of 102.4. Fever was reduced to 100.2 using Motrin and Tylenol throughout the day and night. Patient vomited violently at 11:20 pm.  Fever and vomiting continued until Friday morning, Friday November 25th (fever ranging from 100.3-103.2 F). Patient was taken to urgent care on Friday and was checked for covid 19, RSV, and the flu all which rendered negative, no sign of ear infection, and lungs as well as oxygen levels were normal. Patient continued with a fever all day Friday and Saturday afternoon (November 25-26). Fever subsided by Saturday night and was gone Sunday (November 27th), but patient has now developed a rash behind his ears and on his face.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Rash, Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Skin warm, Vomiting
Clinical narrative: Patient  was administered vaccine on left thigh on Monday, November 21st. The condition of the patient at the time was normal, did not have any illnesses nor medical conditions (i.e. no cough, fever, no rashes, nor any ailments). The following day (November 22nd), in the morning when the patient woke up, while I (parent) was changing him, I noticed the injection site to be enlarged, swollen, and red (roughly around 3 inches in diameter). That evening, patient felt warm. The following morning (November 23rd), the injection site was even larger, more red, and swollen (roughy around 4 inches in diameter) and was accompanied by a fever of 102.4. Fever was reduced to 100.2 using Motrin and Tylenol throughout the day and night. Patient vomited violently at 11:20 pm.  Fever and vomiting continued until Friday morning, Friday November 25th (fever ranging from 100.3-103.2 F). Patient was taken to urgent care on Friday and was checked for covid 19, RSV, and the flu all which rendered negative, no sign of ear infection, and lungs as well as oxygen levels were normal. Patient continued with a fever all day Friday and Saturday afternoon (November 25-26). Fever subsided by Saturday night and was gone Sunday (November 27th), but patient has now developed a rash behind his ears and on his face.
Age: 48.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Product storage error
Clinical narrative: Vaccine vial was punctured on Friday 11/18/22 at approximately 10am and 6 doses drawn up into syringes. These syringes were stored at room temperature. Dose administered to the patient on 11/21/22 was from a syringe that had been drawn up on Friday 11/18 and stored at room temp.  Pfizer contacted for stability information, which they did not have for these storage conditions. Patient is being contacted for re-vaccination.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood gases, Cardiac stress test, Chronic fatigue syndrome, Computerised tomogram thorax, Dyspnoea
Clinical narrative: Starting after second vaccine developed POTS, persistent sinus tachycardia, SOB (dyspenea), ovaries started functioning again with cyclical menses and removed and stopped HRT (and ruled out PMP bleeding), syncopal episodes resulting in injuries, Myalgic encephaitis, CFS/fibromyalgia, MCA-S, TIA's, IBS,  Loop recorder inserted.  Numerous EKG's.  Injuries from new onset of syncopal epidsodes
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Fibromyalgia, Hormone replacement therapy
Clinical narrative: Starting after second vaccine developed POTS, persistent sinus tachycardia, SOB (dyspenea), ovaries started functioning again with cyclical menses and removed and stopped HRT (and ruled out PMP bleeding), syncopal episodes resulting in injuries, Myalgic encephaitis, CFS/fibromyalgia, MCA-S, TIA's, IBS,  Loop recorder inserted.  Numerous EKG's.  Injuries from new onset of syncopal epidsodes
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Implantable cardiac monitor insertion, Injury, Irritable bowel syndrome, Laboratory test, Magnetic resonance imaging head
Clinical narrative: Starting after second vaccine developed POTS, persistent sinus tachycardia, SOB (dyspenea), ovaries started functioning again with cyclical menses and removed and stopped HRT (and ruled out PMP bleeding), syncopal episodes resulting in injuries, Myalgic encephaitis, CFS/fibromyalgia, MCA-S, TIA's, IBS,  Loop recorder inserted.  Numerous EKG's.  Injuries from new onset of syncopal epidsodes
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstruation irregular, Post viral fatigue syndrome, Postural orthostatic tachycardia syndrome, Pulmonary function test, Sinus tachycardia
Clinical narrative: Starting after second vaccine developed POTS, persistent sinus tachycardia, SOB (dyspenea), ovaries started functioning again with cyclical menses and removed and stopped HRT (and ruled out PMP bleeding), syncopal episodes resulting in injuries, Myalgic encephaitis, CFS/fibromyalgia, MCA-S, TIA's, IBS,  Loop recorder inserted.  Numerous EKG's.  Injuries from new onset of syncopal epidsodes
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Stress echocardiogram, Syncope, Tilt table test, Transient ischaemic attack, Ultrasound pelvis
Clinical narrative: Starting after second vaccine developed POTS, persistent sinus tachycardia, SOB (dyspenea), ovaries started functioning again with cyclical menses and removed and stopped HRT (and ruled out PMP bleeding), syncopal episodes resulting in injuries, Myalgic encephaitis, CFS/fibromyalgia, MCA-S, TIA's, IBS,  Loop recorder inserted.  Numerous EKG's.  Injuries from new onset of syncopal epidsodes
Age: 72.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Product storage error
Clinical narrative: Vaccine vial was punctured on Friday 11/18/22 at approximately 10am and 6 doses drawn up into syringes. These syringes were stored at room temperature. Dose administered to the patient on 11/21/22 was from a syringe that had been drawn up on Friday 11/18 and stored at room temp.  Pfizer contacted for stability information, which they did not have for these storage conditions. Patient is being contacted for re-vaccination.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Pfizer bivalent COVID  vaccine vial was punctured on Friday 11/18/22 at approximately 10am and 6 doses drawn up into syringes. These syringes were stored at room temperature. Dose administered to the patient on 11/21/22 was from a syringe that had been drawn up on Friday 11/18 and stored at room temp.  Pfizer contacted for stability information, which they did not have for these storage conditions. Patient is being contacted for re-vaccination.
Age: 81.0
Sex: F
Vaccine: FLUA4
Symptoms: Extra dose administered
Clinical narrative: Patient received 2 high dose flu shots two weeks apart in error.
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Pfizer bivalent COVID  vaccine vial was punctured on Friday 11/18/22 at approximately 10am and 6 doses drawn up into syringes. These syringes were stored at room temperature. Dose administered to the patient on 11/21/22 was from a syringe that had been drawn up on Friday 11/18 and stored at room temp.  Pfizer contacted for stability information, which they did not have for these storage conditions. Patient is being contacted for re-vaccination.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching and hives starting from feet and then spreading to itching and hives on legs, back, stomach, arms, hands and feet.   Has not stopped since then.  Did take 2nd dose of pfizer on 5/6/21, Moderna booster on 11/6/21 and Pfizer booster on 5/15/22.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia
Clinical narrative: PROLONGED DEBILITATING PAIN IN SHOULDER
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient came in to receive her 2nd booster dose, which should have been bivalent. However, patient was accidentally administered a COVID Pfizer monovalent vaccine. She will return in 2 months to receive a bivalent vaccine.
Age: 49.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Cardiac failure congestive, Influenza like illness, Malaise, Mitral valve replacement, Mobility decreased
Clinical narrative: After I got the 1st Covid shot I was sick for 3 weeks then I got the second shot an became deathly sick the next day. I thought I had the flu or Covid. I stayed in bed till October 31 2021 an my boy friend called a ambulance. I was diagnosed with congestive heart failure and I'd never had heart problems in my life. I had to undergo open heart surgery on dec 22 21 for mitral arota vale replacement valve repair
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: The first vaccine that patient received in the series was the Bivalent Booster erroneously. Patient was reported to be fine afterwards. This report is designed as informative to the wrong shot administration.
Age: 26.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Fatigue, Headache, Lymphadenopathy, Nasal congestion
Clinical narrative: The next day after the vaccine (Tuesday), I started feeling tired and feverish. On Wednesday I had a headache and respiratory symptoms (stuffed nose/runny nose). I took a COVID test that day and the result was negative. Later that day I had a fever and started coughing with mucus and had swollen lymph node on my underarm. I took a COVID test again on Thursday (11/24) and it was also negative. I still had  a cough. On Saturday my symptoms improved. My husband started developing  a cough and respiratory symptoms on Saturday - we both had the fourth dose on the same day.  Before Saturday he only had muscle ache  and swollen lymph nodes. This morning (Sunday) we both took COVID tests and they turned out positive. Since the start of the COVID-19 pandemic we never tested positive (we tested a couple of times for work and travel).
Age: 26.0
Sex: F
Vaccine: COVID19-2
Symptoms: Productive cough, Pyrexia, Respiratory symptom, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: The next day after the vaccine (Tuesday), I started feeling tired and feverish. On Wednesday I had a headache and respiratory symptoms (stuffed nose/runny nose). I took a COVID test that day and the result was negative. Later that day I had a fever and started coughing with mucus and had swollen lymph node on my underarm. I took a COVID test again on Thursday (11/24) and it was also negative. I still had  a cough. On Saturday my symptoms improved. My husband started developing  a cough and respiratory symptoms on Saturday - we both had the fourth dose on the same day.  Before Saturday he only had muscle ache  and swollen lymph nodes. This morning (Sunday) we both took COVID tests and they turned out positive. Since the start of the COVID-19 pandemic we never tested positive (we tested a couple of times for work and travel).
Age: 26.0
Sex: F
Vaccine: COVID19-2
Symptoms: Secretion discharge
Clinical narrative: The next day after the vaccine (Tuesday), I started feeling tired and feverish. On Wednesday I had a headache and respiratory symptoms (stuffed nose/runny nose). I took a COVID test that day and the result was negative. Later that day I had a fever and started coughing with mucus and had swollen lymph node on my underarm. I took a COVID test again on Thursday (11/24) and it was also negative. I still had  a cough. On Saturday my symptoms improved. My husband started developing  a cough and respiratory symptoms on Saturday - we both had the fourth dose on the same day.  Before Saturday he only had muscle ache  and swollen lymph nodes. This morning (Sunday) we both took COVID tests and they turned out positive. Since the start of the COVID-19 pandemic we never tested positive (we tested a couple of times for work and travel).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Cerebrovascular accident, Computerised tomogram, Magnetic resonance imaging, Neurological symptom
Clinical narrative: Stroke- effected loss of left side. Hospital 2 week inpatient rehab 6 weeks 4 moths ongoing outpatient rehab.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: Stroke- effected loss of left side. Hospital 2 week inpatient rehab 6 weeks 4 moths ongoing outpatient rehab.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Audiogram abnormal, Deafness, Tinnitus
Clinical narrative: I started noticing continuous ringing in my ears in December 2021. Mentioned this during a doctor's visit in April 2022 and it was recommended I have an audiogram. Had audiogram with Dr May 3, 2022. By that time I had figured out that the ringing started after my Moderna booster (3rd shot). I'm not sure the ringing was caused by the shot, but Dr did say it was certainly possible. I want to share my history with this in case there are others who have had the same thing happen. Since then, I have had a fourth shot, had Covid, and had a fifth shot and the ringing is slowly getting louder.
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash
Clinical narrative: Rash on torso front n back
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood immunoglobulin G increased, Blood test, Butterfly rash, Computerised tomogram abdomen
Clinical narrative: Within a week of the Moderna booster, I started having eye infections and dizziness. Then about three weeks later I had a sudden explosion of symptoms: extreme pain radiating from the bridge of my nose that felt like my nose breaking, intense pain and pressure in face, malar rash, rashes, spots and lumps all over skin, visual reduction, visual snow, visual disturbances, head pain and pressure, difficulty processing light and sound, whole lower half of face swelled up and has remained swollen for almost one year now, veins swelled up, muscles weakened and wasted away, exercise intolerance, lost 6-7 pounds of weight when I was already small. Entire face looks like it aged 50 years. Saggy skin everywhere hanging off my bones. Extreme insomnia, heart racing, allergies to everything, destruction of my sinuses, no energy, extreme fatigue. I have been sick for almost a year now with no improvement. My doctors recognize the vaccine caused this and have said the vaccine induced an immune reaction that they cannot figure out how to stop. I was a healthy thirty-one-year-old and now can barely function.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head, Computerised tomogram neck, Computerised tomogram thorax, Discomfort, Dizziness
Clinical narrative: Within a week of the Moderna booster, I started having eye infections and dizziness. Then about three weeks later I had a sudden explosion of symptoms: extreme pain radiating from the bridge of my nose that felt like my nose breaking, intense pain and pressure in face, malar rash, rashes, spots and lumps all over skin, visual reduction, visual snow, visual disturbances, head pain and pressure, difficulty processing light and sound, whole lower half of face swelled up and has remained swollen for almost one year now, veins swelled up, muscles weakened and wasted away, exercise intolerance, lost 6-7 pounds of weight when I was already small. Entire face looks like it aged 50 years. Saggy skin everywhere hanging off my bones. Extreme insomnia, heart racing, allergies to everything, destruction of my sinuses, no energy, extreme fatigue. I have been sick for almost a year now with no improvement. My doctors recognize the vaccine caused this and have said the vaccine induced an immune reaction that they cannot figure out how to stop. I was a healthy thirty-one-year-old and now can barely function.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Excessive skin, Exercise tolerance decreased, Eye infection, Facial pain, Fatigue
Clinical narrative: Within a week of the Moderna booster, I started having eye infections and dizziness. Then about three weeks later I had a sudden explosion of symptoms: extreme pain radiating from the bridge of my nose that felt like my nose breaking, intense pain and pressure in face, malar rash, rashes, spots and lumps all over skin, visual reduction, visual snow, visual disturbances, head pain and pressure, difficulty processing light and sound, whole lower half of face swelled up and has remained swollen for almost one year now, veins swelled up, muscles weakened and wasted away, exercise intolerance, lost 6-7 pounds of weight when I was already small. Entire face looks like it aged 50 years. Saggy skin everywhere hanging off my bones. Extreme insomnia, heart racing, allergies to everything, destruction of my sinuses, no energy, extreme fatigue. I have been sick for almost a year now with no improvement. My doctors recognize the vaccine caused this and have said the vaccine induced an immune reaction that they cannot figure out how to stop. I was a healthy thirty-one-year-old and now can barely function.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: General physical condition abnormal, Head discomfort, Headache, Immunisation reaction, Insomnia
Clinical narrative: Within a week of the Moderna booster, I started having eye infections and dizziness. Then about three weeks later I had a sudden explosion of symptoms: extreme pain radiating from the bridge of my nose that felt like my nose breaking, intense pain and pressure in face, malar rash, rashes, spots and lumps all over skin, visual reduction, visual snow, visual disturbances, head pain and pressure, difficulty processing light and sound, whole lower half of face swelled up and has remained swollen for almost one year now, veins swelled up, muscles weakened and wasted away, exercise intolerance, lost 6-7 pounds of weight when I was already small. Entire face looks like it aged 50 years. Saggy skin everywhere hanging off my bones. Extreme insomnia, heart racing, allergies to everything, destruction of my sinuses, no energy, extreme fatigue. I have been sick for almost a year now with no improvement. My doctors recognize the vaccine caused this and have said the vaccine induced an immune reaction that they cannot figure out how to stop. I was a healthy thirty-one-year-old and now can barely function.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Magnetic resonance imaging head, Malaise, Multiple allergies, Muscle atrophy
Clinical narrative: Within a week of the Moderna booster, I started having eye infections and dizziness. Then about three weeks later I had a sudden explosion of symptoms: extreme pain radiating from the bridge of my nose that felt like my nose breaking, intense pain and pressure in face, malar rash, rashes, spots and lumps all over skin, visual reduction, visual snow, visual disturbances, head pain and pressure, difficulty processing light and sound, whole lower half of face swelled up and has remained swollen for almost one year now, veins swelled up, muscles weakened and wasted away, exercise intolerance, lost 6-7 pounds of weight when I was already small. Entire face looks like it aged 50 years. Saggy skin everywhere hanging off my bones. Extreme insomnia, heart racing, allergies to everything, destruction of my sinuses, no energy, extreme fatigue. I have been sick for almost a year now with no improvement. My doctors recognize the vaccine caused this and have said the vaccine induced an immune reaction that they cannot figure out how to stop. I was a healthy thirty-one-year-old and now can barely function.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain, Palpitations, Peripheral venous disease, Rash
Clinical narrative: Within a week of the Moderna booster, I started having eye infections and dizziness. Then about three weeks later I had a sudden explosion of symptoms: extreme pain radiating from the bridge of my nose that felt like my nose breaking, intense pain and pressure in face, malar rash, rashes, spots and lumps all over skin, visual reduction, visual snow, visual disturbances, head pain and pressure, difficulty processing light and sound, whole lower half of face swelled up and has remained swollen for almost one year now, veins swelled up, muscles weakened and wasted away, exercise intolerance, lost 6-7 pounds of weight when I was already small. Entire face looks like it aged 50 years. Saggy skin everywhere hanging off my bones. Extreme insomnia, heart racing, allergies to everything, destruction of my sinuses, no energy, extreme fatigue. I have been sick for almost a year now with no improvement. My doctors recognize the vaccine caused this and have said the vaccine induced an immune reaction that they cannot figure out how to stop. I was a healthy thirty-one-year-old and now can barely function.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Sensory processing disorder, Sinus disorder, Skin discolouration, Skin mass, Swelling face
Clinical narrative: Within a week of the Moderna booster, I started having eye infections and dizziness. Then about three weeks later I had a sudden explosion of symptoms: extreme pain radiating from the bridge of my nose that felt like my nose breaking, intense pain and pressure in face, malar rash, rashes, spots and lumps all over skin, visual reduction, visual snow, visual disturbances, head pain and pressure, difficulty processing light and sound, whole lower half of face swelled up and has remained swollen for almost one year now, veins swelled up, muscles weakened and wasted away, exercise intolerance, lost 6-7 pounds of weight when I was already small. Entire face looks like it aged 50 years. Saggy skin everywhere hanging off my bones. Extreme insomnia, heart racing, allergies to everything, destruction of my sinuses, no energy, extreme fatigue. I have been sick for almost a year now with no improvement. My doctors recognize the vaccine caused this and have said the vaccine induced an immune reaction that they cannot figure out how to stop. I was a healthy thirty-one-year-old and now can barely function.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment, Visual snow syndrome, Weight decreased
Clinical narrative: Within a week of the Moderna booster, I started having eye infections and dizziness. Then about three weeks later I had a sudden explosion of symptoms: extreme pain radiating from the bridge of my nose that felt like my nose breaking, intense pain and pressure in face, malar rash, rashes, spots and lumps all over skin, visual reduction, visual snow, visual disturbances, head pain and pressure, difficulty processing light and sound, whole lower half of face swelled up and has remained swollen for almost one year now, veins swelled up, muscles weakened and wasted away, exercise intolerance, lost 6-7 pounds of weight when I was already small. Entire face looks like it aged 50 years. Saggy skin everywhere hanging off my bones. Extreme insomnia, heart racing, allergies to everything, destruction of my sinuses, no energy, extreme fatigue. I have been sick for almost a year now with no improvement. My doctors recognize the vaccine caused this and have said the vaccine induced an immune reaction that they cannot figure out how to stop. I was a healthy thirty-one-year-old and now can barely function.
Age: 17.0
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old patient was given FluBlok which is indicated for patient's 18 years or older
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Cartilage injury, Magnetic resonance imaging, Muscle rupture
Clinical narrative: torn muscles and labrum in shoulder
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort, Mobility decreased, Musculoskeletal pain, Myalgia, Neuralgia
Clinical narrative: Patient states she started having severe side effects the next day after receiving her 2nd dose of Shingrix. She stared to have a fever, nerve pain radiated on her left side down to her buttocks and myalgia. In addition her injection arm felt heavy and her mobility has greatly decreased. She has taken tylenol 500mg which somewhat helped her symptoms. The fever has resolve about a day after symptom on set. Symptoms has been going on for a bout 3 days. I recommended the patient if her symptoms does not improve in another day to refer her to urgent care for further evaluation.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Patient states she started having severe side effects the next day after receiving her 2nd dose of Shingrix. She stared to have a fever, nerve pain radiated on her left side down to her buttocks and myalgia. In addition her injection arm felt heavy and her mobility has greatly decreased. She has taken tylenol 500mg which somewhat helped her symptoms. The fever has resolve about a day after symptom on set. Symptoms has been going on for a bout 3 days. I recommended the patient if her symptoms does not improve in another day to refer her to urgent care for further evaluation.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injury associated with device, Needle issue, Occupational exposure to product
Clinical narrative: While beginning to remove the plastic needle cover from a syringe that had been filled by anther staff member who was not in the clinic the morning of November 26th, the needle punctured through the plastic cap and into my left thumb. On further inspection, I could see that the needle was bent and piercing the plastic needle cover. I told the office manager and washed my hands and put a sterile band aid over the affected area.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Confusional state, Fatigue, Headache, Memory impairment
Clinical narrative: 11/18/22 early morning hour was able to go to the bathroom but was confused and did not know what day it was according to my sister who called and thought I was extremely tired.  Slept the whole day with no meds or food taken.  11/19, 20, 21 was able to start my day but was feeling nausea, headache and tired.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Somnolence
Clinical narrative: 11/18/22 early morning hour was able to go to the bathroom but was confused and did not know what day it was according to my sister who called and thought I was extremely tired.  Slept the whole day with no meds or food taken.  11/19, 20, 21 was able to start my day but was feeling nausea, headache and tired.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: patient stated she was having pain in arm from vaccine for a couple months. patient was recommended to go see pcp for further evaluation
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lethargy, Pain, Petechiae
Clinical narrative: Petechaie 24 hours after administration and lasting about a week. I can share a photo but I do not see a place to upload an image. Body aches, fever (102), extreme fatigue and lethargy, chills and shakes. Symptoms onset at 8 hours, resolved at 72 hours. My reaction to all the COVID vaccines have been quite intense.  Given the petechiae, I would like advise on whether or not I should get the Bivalent vaccine on December 9th as schedule.  I am a nurse and would like to get this booster.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: Petechaie 24 hours after administration and lasting about a week. I can share a photo but I do not see a place to upload an image. Body aches, fever (102), extreme fatigue and lethargy, chills and shakes. Symptoms onset at 8 hours, resolved at 72 hours. My reaction to all the COVID vaccines have been quite intense.  Given the petechiae, I would like advise on whether or not I should get the Bivalent vaccine on December 9th as schedule.  I am a nurse and would like to get this booster.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Croup infectious
Clinical narrative: Patient contracted croupe at school. No indication the vaccine had anything to do with it. Significant time had passed between the illness and her third vaccine dose.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Immediate post-injection reaction, Muscle swelling, Pain, Peripheral swelling
Clinical narrative: Immediate itchiness and pain. On Saturday morning, November 26, my bicep was red, swollen and itchy. On Sunday, November 27, my arm was red, swollen, itchy and hot to the touch.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pruritus, Skin warm
Clinical narrative: Immediate itchiness and pain. On Saturday morning, November 26, my bicep was red, swollen and itchy. On Sunday, November 27, my arm was red, swollen, itchy and hot to the touch.
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Impaired driving ability, Injection site joint swelling, Injection site pain, Injection site swelling, Joint swelling
Clinical narrative: On 11/23/2022, roughly 3 hours after injection, injection site began to swell. With in 5 hours of injection, extreme pain in right arm in vicinity of injection site (front deltoid).  This was followed by  skin pain along spine and ribs and extreme muscle tightness in arms and upper back.  Experienced. Pain treated with 75mg  diclofenac and 1 mg tizanidine.  Joint swelling, extreme soreness and muscle tightness continued on 11/24 through 11/25  and managed with diclofenac (75 mg every 12 hours).  On  11/26/2022, joint swelling occurred in wrists, left hip, right foot, right shoulder.  Painful swelling in right  foot  occurred to point where I could not drive (site of sprain in June 2022) . Managed with  75 mg diclofenac, vitamin B, magnesium, 1 mg tizanidine.  As of  11/27, right arm injection still painful, still experiencing inflammation, though to much lesser extent than previous days. Contacted primary care virtually.
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Muscle tightness, Pain in extremity, Pain of skin, Peripheral swelling
Clinical narrative: On 11/23/2022, roughly 3 hours after injection, injection site began to swell. With in 5 hours of injection, extreme pain in right arm in vicinity of injection site (front deltoid).  This was followed by  skin pain along spine and ribs and extreme muscle tightness in arms and upper back.  Experienced. Pain treated with 75mg  diclofenac and 1 mg tizanidine.  Joint swelling, extreme soreness and muscle tightness continued on 11/24 through 11/25  and managed with diclofenac (75 mg every 12 hours).  On  11/26/2022, joint swelling occurred in wrists, left hip, right foot, right shoulder.  Painful swelling in right  foot  occurred to point where I could not drive (site of sprain in June 2022) . Managed with  75 mg diclofenac, vitamin B, magnesium, 1 mg tizanidine.  As of  11/27, right arm injection still painful, still experiencing inflammation, though to much lesser extent than previous days. Contacted primary care virtually.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Facial pain, Inflammation, Lymphadenopathy, Swelling face
Clinical narrative: Facial pain, swelling, and inflammation; swollen glands under chin,  no treatment,
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Foreign body in throat, Vomiting
Clinical narrative: Was vomiting violently the day after the shot and something (fluid, mucus) got stuck in my throat and I literally could not breathe for 1 to 2 mins. Issue resolved but was gasping for air.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pulmonary function test, Walking distance test
Clinical narrative: Shortness of breath- no previous problems.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, Dysarthria, Facial asymmetry, Hemiparesis
Clinical narrative: DEATH; FACIAL ASYMMETRY; HEMIPARESIS; DYSARTHRIA; COVID-19; HEMIPARESIS; DYSARTHRIA; DEATH; FACIAL ASYMMETRY; COVID-19; MENTAL STATUS CHANGES; NEUROLOGICAL SYMPTOM; SARS-COV-2 TEST POSITIVE; This spontaneous report received from a health care professional via Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 2481619) concerned an 88 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, atrial fibrillation, dementia, and congestive heart failure with reduced ejection fraction. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A, expiry: unknown) dose was not reported, 1 total administered on 11-MAY-2021 in left arm for an unspecified indication. Age at time of vaccination 87 years old. No concomitant medications were reported.  On 24-SEP-2022, the patient presented to the emergency department (ED) with Altered mental status (AMS) (mental status changes), stroke like symptoms (neurological symptom), R (right) sided weakness (hemiparesis), unequal smile (facial asymmetry), slurred speech (dysarthria), and COVID-19 positive. Laboratory data included: SARS-CoV-2 test Positive. Treatment medications (dates unspecified) included: dexamethasone, remdesivir, high flow of (O2) oxygen and nebulizers. Patient was hospitalized for 16 days from 24-SEP-2022 to 10-OCT-2022. Discharge to: Hospice. Patient was deceased (death) and was passed on 10-OCT-2022. It was unspecified if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died from covid-19, dysarthria, facial asymmetry, hemiparesis, mental status changes, neurological symptom and sars-cov-2 test positive on 10-OCT-2022. This report was serious (Death, and Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000257585. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Additional information was received from Regulatory Authority on 24-NOV-2022. The following information was updated and incorporated into case narrative: product quality complaint investigation result.; Sender's Comments: V2: Additional information in this version updates: Product quality complaint investigation result, This updated information does not change the causality of the previously reported events. 20221060956-Death, covid-19, dysarthria, facial asymmetry, hemiparesis, mental status changes, neurological symptom, SARS-CoV-2 test Positive. The event shows an incompatible temporal relationship. Therefore, this event is considered inconsistent with vaccine administration.; Reported Cause(s) of Death: COVID-19; DYSARTHRIA; FACIAL ASYMMETRY; HEMIPARESIS; MENTAL STATUS CHANGES; NEUROLOGICAL SYMPTOM
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mental status changes, Neurological symptom, SARS-CoV-2 test positive
Clinical narrative: DEATH; FACIAL ASYMMETRY; HEMIPARESIS; DYSARTHRIA; COVID-19; HEMIPARESIS; DYSARTHRIA; DEATH; FACIAL ASYMMETRY; COVID-19; MENTAL STATUS CHANGES; NEUROLOGICAL SYMPTOM; SARS-COV-2 TEST POSITIVE; This spontaneous report received from a health care professional via Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 2481619) concerned an 88 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, atrial fibrillation, dementia, and congestive heart failure with reduced ejection fraction. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A, expiry: unknown) dose was not reported, 1 total administered on 11-MAY-2021 in left arm for an unspecified indication. Age at time of vaccination 87 years old. No concomitant medications were reported.  On 24-SEP-2022, the patient presented to the emergency department (ED) with Altered mental status (AMS) (mental status changes), stroke like symptoms (neurological symptom), R (right) sided weakness (hemiparesis), unequal smile (facial asymmetry), slurred speech (dysarthria), and COVID-19 positive. Laboratory data included: SARS-CoV-2 test Positive. Treatment medications (dates unspecified) included: dexamethasone, remdesivir, high flow of (O2) oxygen and nebulizers. Patient was hospitalized for 16 days from 24-SEP-2022 to 10-OCT-2022. Discharge to: Hospice. Patient was deceased (death) and was passed on 10-OCT-2022. It was unspecified if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died from covid-19, dysarthria, facial asymmetry, hemiparesis, mental status changes, neurological symptom and sars-cov-2 test positive on 10-OCT-2022. This report was serious (Death, and Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000257585. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Additional information was received from Regulatory Authority on 24-NOV-2022. The following information was updated and incorporated into case narrative: product quality complaint investigation result.; Sender's Comments: V2: Additional information in this version updates: Product quality complaint investigation result, This updated information does not change the causality of the previously reported events. 20221060956-Death, covid-19, dysarthria, facial asymmetry, hemiparesis, mental status changes, neurological symptom, SARS-CoV-2 test Positive. The event shows an incompatible temporal relationship. Therefore, this event is considered inconsistent with vaccine administration.; Reported Cause(s) of Death: COVID-19; DYSARTHRIA; FACIAL ASYMMETRY; HEMIPARESIS; MENTAL STATUS CHANGES; NEUROLOGICAL SYMPTOM
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mental status changes, Neurological symptom, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: DEATH; FACIAL ASYMMETRY; HEMIPARESIS; DYSARTHRIA; COVID-19; HEMIPARESIS; DYSARTHRIA; DEATH; FACIAL ASYMMETRY; COVID-19; MENTAL STATUS CHANGES; NEUROLOGICAL SYMPTOM; SARS-COV-2 TEST POSITIVE; This spontaneous report received from a health care professional via Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 2481619) concerned an 88 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, atrial fibrillation, dementia, and congestive heart failure with reduced ejection fraction. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A, expiry: unknown) dose was not reported, 1 total administered on 11-MAY-2021 in left arm for an unspecified indication. Age at time of vaccination 87 years old. No concomitant medications were reported.  On 24-SEP-2022, the patient presented to the emergency department (ED) with Altered mental status (AMS) (mental status changes), stroke like symptoms (neurological symptom), R (right) sided weakness (hemiparesis), unequal smile (facial asymmetry), slurred speech (dysarthria), and COVID-19 positive. Laboratory data included: SARS-CoV-2 test Positive. Treatment medications (dates unspecified) included: dexamethasone, remdesivir, high flow of (O2) oxygen and nebulizers. Patient was hospitalized for 16 days from 24-SEP-2022 to 10-OCT-2022. Discharge to: Hospice. Patient was deceased (death) and was passed on 10-OCT-2022. It was unspecified if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died from covid-19, dysarthria, facial asymmetry, hemiparesis, mental status changes, neurological symptom and sars-cov-2 test positive on 10-OCT-2022. This report was serious (Death, and Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000257585. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Additional information was received from Regulatory Authority on 24-NOV-2022. The following information was updated and incorporated into case narrative: product quality complaint investigation result.; Sender's Comments: V2: Additional information in this version updates: Product quality complaint investigation result, This updated information does not change the causality of the previously reported events. 20221060956-Death, covid-19, dysarthria, facial asymmetry, hemiparesis, mental status changes, neurological symptom, SARS-CoV-2 test Positive. The event shows an incompatible temporal relationship. Therefore, this event is considered inconsistent with vaccine administration.; Reported Cause(s) of Death: COVID-19; DYSARTHRIA; FACIAL ASYMMETRY; HEMIPARESIS; MENTAL STATUS CHANGES; NEUROLOGICAL SYMPTOM
Age: 57.0
Sex: M
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Dizziness, Loss of consciousness, Venipuncture
Clinical narrative: Syncope after vaccination and venipuncture
Age: 57.0
Sex: M
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Syncope
Clinical narrative: Syncope after vaccination and venipuncture
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site pain, Vaccination site warmth
Clinical narrative: also had a melanoma develop on his back; Patient had a warm feeling at the injection site; Patient had some swelling at the injection site; Patient had some tenderness at the injection site; This spontaneous case was reported by a patient and describes the occurrence of MALIGNANT MELANOMA (also had a melanoma develop on his back) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007H20A and 011L20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced MALIGNANT MELANOMA (also had a melanoma develop on his back) (seriousness criterion medically significant), VACCINATION SITE WARMTH (Patient had a warm feeling at the injection site), VACCINATION SITE SWELLING (Patient had some swelling at the injection site) and VACCINATION SITE PAIN (Patient had some tenderness at the injection site). At the time of the report, MALIGNANT MELANOMA (also had a melanoma develop on his back), VACCINATION SITE WARMTH (Patient had a warm feeling at the injection site), VACCINATION SITE SWELLING (Patient had some swelling at the injection site) and VACCINATION SITE PAIN (Patient had some tenderness at the injection site) outcome was unknown.            Concomitant medications details were not reported by the reporter.  The patient also had a melanoma develop on back. The patient says the melanoma was related to sun damage. The melanoma was removed.  Treatment details were not reported by the reporter.  Company comment: This spontaneous case reported by a patient, concerns a 78-year-old, male patient with no medical history reported, who experienced the unexpected serious (medically significant) event of Malignant melanoma. The event occurred on the same day of receiving second dose of mRNA-1273 vaccine in COVID 19 vaccination series. Reporter stated that the melanoma was reported to the sun damage, and it was removed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-676537, MOD-2022-676549, MOD-2022-676551 (Patient Link).; Sender's Comments: This spontaneous case reported by a patient, concerns a 78-year-old, male patient with no medical history reported, who experienced the unexpected serious (medically significant) event of Malignant melanoma. The event occurred on the same day of receiving second dose of mRNA-1273 vaccine in COVID 19 vaccination series. Reporter stated that the melanoma was reported to the sun damage, and it was removed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Malignant melanoma, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: also had a melanoma develop on his back; Patient had a warm feeling at the injection site; Patient had some swelling at the injection site; Patient had some tenderness at the injection site; This spontaneous case was reported by a patient and describes the occurrence of MALIGNANT MELANOMA (also had a melanoma develop on his back) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007H20A and 011L20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced MALIGNANT MELANOMA (also had a melanoma develop on his back) (seriousness criterion medically significant), VACCINATION SITE WARMTH (Patient had a warm feeling at the injection site), VACCINATION SITE SWELLING (Patient had some swelling at the injection site) and VACCINATION SITE PAIN (Patient had some tenderness at the injection site). At the time of the report, MALIGNANT MELANOMA (also had a melanoma develop on his back), VACCINATION SITE WARMTH (Patient had a warm feeling at the injection site), VACCINATION SITE SWELLING (Patient had some swelling at the injection site) and VACCINATION SITE PAIN (Patient had some tenderness at the injection site) outcome was unknown.            Concomitant medications details were not reported by the reporter.  The patient also had a melanoma develop on back. The patient says the melanoma was related to sun damage. The melanoma was removed.  Treatment details were not reported by the reporter.  Company comment: This spontaneous case reported by a patient, concerns a 78-year-old, male patient with no medical history reported, who experienced the unexpected serious (medically significant) event of Malignant melanoma. The event occurred on the same day of receiving second dose of mRNA-1273 vaccine in COVID 19 vaccination series. Reporter stated that the melanoma was reported to the sun damage, and it was removed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-676537, MOD-2022-676549, MOD-2022-676551 (Patient Link).; Sender's Comments: This spontaneous case reported by a patient, concerns a 78-year-old, male patient with no medical history reported, who experienced the unexpected serious (medically significant) event of Malignant melanoma. The event occurred on the same day of receiving second dose of mRNA-1273 vaccine in COVID 19 vaccination series. Reporter stated that the melanoma was reported to the sun damage, and it was removed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.