chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Blood test, Computerised tomogram, Giant cell arteritis, Magnetic resonance imaging
Clinical narrative: Severe Arthritis, GCA - Giant Cell Arthritis , PMR - Polymyalgia Rheumatica
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica, Ultrasound Doppler, X-ray
Clinical narrative: Severe Arthritis, GCA - Giant Cell Arthritis , PMR - Polymyalgia Rheumatica
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Urticaria, Vomiting
Clinical narrative: 11/15/2022, 7:00pm -- vomited; 11/19/2022, woke up with severe hives on right leg, called after hours pediatrics, instructed to give allergy medication until hives clear -- began children's Zyrtec, continue watching for other symptoms of reaction
Age: 9.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Incorrect dose administered
Clinical narrative: We gave patient 0.5ml instead of recommended 0.25ml. We found out the mistake the next day. Contacted dad and patient is doing fine, little tired but ok
Age: 7.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Malaise
Clinical narrative: 0.5ml was administered to the patient instead of recommended 0.25ml. Spoke with dad the next day and patient is doing fine, a little under the weather but doing fine per dad
Age: 6.0
Sex: M
Vaccine: COVID19-2
Symptoms: Vomiting
Clinical narrative: Repeated vomiting
Age: 6.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Vial was not diluted prior to administration. No adverse events were reported back to us. Will contact patient's PCP this week since this is a weekend and offices are closed.
Age: 11.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: Patient was to receive the Pfizer updated bivalent booster but the vaccine was given without the diluent. Patient received a concentrated dose of the booster; 0.2ml of undiluted vaccine was administered. Family member, who also works in the pharmacy, called later that evening to report she remembered not diluting the vial before she told the technician to draw up 0.2ml for the dose. I advised her to monitor for any allergic reaction and educated her on possible adverse reactions that could occur. No adverse reactions were reported as of two days post vaccination.
Sex: U
Vaccine: COVID19-2
Symptoms: Blister, Intensive care, Skin graft
Clinical narrative: Severe blistering ,emergency admit to burn unit at local hospital.  3 skin grafts, intensive care unit stay for 5 weeks
Age: 58.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Injected limb mobility decreased, Insomnia, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Unbearable pain on the left hand (Vaccine was given on left hand) for about two days. I could not even move my left hand. Was not able to do my day-to-day activities and could not sleep. Pain is now reducing but it is almost a week since I took this shot, my left hand is not yet normal. Some activities are causing lot of pain and some movements are restricted.  This is due to second shot of Shingles vaccine. Not sure if this falls under adverse effect. But I am reporting it anyways.  I contacted the manufacturer (Glaxosmithkline) immediately but no advise came from them. My family Doctor helped.
Age: 58.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Arthralgia, Impaired driving ability, Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: Unbearable pain on the left hand (Vaccine was given on left hand) for about two days. I could not even move my left hand. Was not able to do my day-to-day activities and could not sleep. Pain is now reducing but it is almost a week since I took this shot, my left hand is not yet normal. Some activities are causing lot of pain and some movements are restricted.  This is due to second shot of Shingles vaccine. Not sure if this falls under adverse effect. But I am reporting it anyways.  I contacted the manufacturer (Glaxosmithkline) immediately but no advise came from them. My family Doctor helped.
Age: 58.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Unbearable pain on the left hand (Vaccine was given on left hand) for about two days. I could not even move my left hand. Was not able to do my day-to-day activities and could not sleep. Pain is now reducing but it is almost a week since I took this shot, my left hand is not yet normal. Some activities are causing lot of pain and some movements are restricted.  This is due to second shot of Shingles vaccine. Not sure if this falls under adverse effect. But I am reporting it anyways.  I contacted the manufacturer (Glaxosmithkline) immediately but no advise came from them. My family Doctor helped.
Age: 11.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: Patient was to receive the Pfizer updated bivalent booster but the vaccine was given without the diluent. Patient received a concentrated dose of the booster; 0.2ml was administered. Parent, who also works in the pharmacy, called later that evening to report she remembered not diluting the vial before she told the technician to draw up 0.2ml for the dose. I advised her to monitor for any allergic reactions and educated her on possible adverse reactions that could occur. No adverse reactions were reported as of two days post vaccination.
Age: 34.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: patient came looking for Covid vaccine. Patient was informed pharmacy only carries Moderna booster.  Patient confirmed this was the vaccine needed.  After administration, patient said this was the first covid vaccine they had received.  Booster was given in error
Age: 11.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Fatigue, Hyperhidrosis
Clinical narrative: Pt given vaccine at 2:22 pm on 11/20/22 to right deltoid. Given per Pfizer instructions and all patient rights followed.  At 3:32 pm patient's mother stated her child felt tired, dizzy, and is sweating. Vital signs taken and they were all within normal limits. Mother states the patient did not have breakfast or fluids all day. Patient monitored for 15 more minutes. Mother gave Tylenol and sports drink to drink. Pt responded well to treatment. Pt stated she felt better.  Vitals normal.  Instructed mother that patient should increase fluid intake, rest, and monitor at home. If symptoms worsen, patient should seek immediate emergent care. Mother verbalized understanding.
Age: 52.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Diarrhoea, Fatigue, Pyrexia
Clinical narrative: Extreme fatigue, chills, diarrhea, fever.
Age: 82.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure diastolic increased, Feeling abnormal, Heart rate increased
Clinical narrative: Patient called pharmacy and indicated that she was "feeling off" after vaccination, Stated that her Diastolic  BP was up about 7 points from normal and that her pulse was elevated to around 90
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Heart rate increased
Clinical narrative: Mildly increased heart rate (90 bpm, normal 60 bpm) and pervasive feeling of anxiety.
Age: 24.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Fatigue, Feeling hot, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: Immediately after receiving dose, I felt light headed and very hot, sweats, like I was about to pass out.   Day after vaccine (11/20/2022) I am having body aches, fatigue, arm pain and selling around the vaccination site
Age: 24.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site swelling, Pain, Pain in extremity, Presyncope
Clinical narrative: Immediately after receiving dose, I felt light headed and very hot, sweats, like I was about to pass out.   Day after vaccine (11/20/2022) I am having body aches, fatigue, arm pain and selling around the vaccination site
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Extensive limb swelling of the left upper arm, shoulder to elbow with significant pain, redness, warmth to touch
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Gait disturbance, Muscle spasms, Muscular weakness
Clinical narrative: Within 15 min of receiving the 2nd shot of the Pfizer COVID vaccination, I was extremely dizzy. The dizzy spells have continued off and on to present. Within 1 hr of receiving the vaccine, I had terrible joint pain in all my joints and got and continue to get severe muscle cramps especially in my legs and cramps in my toes and ankles, and fingers as well.  I also have muscle weakness that developed at that same time and continues.  I can no longer walk upstairs without pulling on railing for assistance or setting clothes basket (for example) on each step and using it like a walker for assist. I was told body aches were "normal" but would pass. This has all persisted for a little over a year with no improvement and worse at times.  I did not have these issues until I got the 2nd COVID injection. Just recently told by my Dr to report it.  I have not taken any of the booster shots due to continued issues since the original 2nd injection.  I was required to get the COVID vaccine to keep my job.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Walking aid user
Clinical narrative: Within 15 min of receiving the 2nd shot of the Pfizer COVID vaccination, I was extremely dizzy. The dizzy spells have continued off and on to present. Within 1 hr of receiving the vaccine, I had terrible joint pain in all my joints and got and continue to get severe muscle cramps especially in my legs and cramps in my toes and ankles, and fingers as well.  I also have muscle weakness that developed at that same time and continues.  I can no longer walk upstairs without pulling on railing for assistance or setting clothes basket (for example) on each step and using it like a walker for assist. I was told body aches were "normal" but would pass. This has all persisted for a little over a year with no improvement and worse at times.  I did not have these issues until I got the 2nd COVID injection. Just recently told by my Dr to report it.  I have not taken any of the booster shots due to continued issues since the original 2nd injection.  I was required to get the COVID vaccine to keep my job.
Age: 73.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: Had Prevnar 20 on 11/19 and fever and arm soreness started after 2 hours, slight swelling and redness noticed on the site. Haven't taken any medication. No more for last 3 hours. Feeling better and swelling and redness stay same
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Mechanical urticaria
Clinical narrative: Dermographism, that has continued up to the present day, nearly 9 months.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Atrial fibrillation, Blood test normal, Chest X-ray normal, Chest pain, Computerised tomogram normal
Clinical narrative: Significant chest pain and shortness of breath over a three day period.  Came on gradually and were significant for days number two and three, then subsided.  The ER ruled out heart attack and pulmonary embolisms.  My primary physician believes it was likely pericarditis.  A night after the symptoms subsided I dropped into continuous a-fib, which I had treated originally back in July.  The pericarditis symptoms are all gone, but I am still in a-fib and will have another cardiogram on 12/1/2022 to try to get me back in rhythm.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Condition aggravated, Dyspnoea, Pericarditis
Clinical narrative: Significant chest pain and shortness of breath over a three day period.  Came on gradually and were significant for days number two and three, then subsided.  The ER ruled out heart attack and pulmonary embolisms.  My primary physician believes it was likely pericarditis.  A night after the symptoms subsided I dropped into continuous a-fib, which I had treated originally back in July.  The pericarditis symptoms are all gone, but I am still in a-fib and will have another cardiogram on 12/1/2022 to try to get me back in rhythm.
Age: 9.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Dizziness, Nausea, Syncope
Clinical narrative: DIZZINESS, SYNCOPE, LIGHTHEADEDNESS, NAUSEA, WEAKNESS
Age: 61.0
Sex: F
Vaccine: PNC20
Symptoms: Contusion, Skin discolouration
Clinical narrative: Brusing - purple skin for the past 4 days
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatic enzyme abnormal, Lymphadenopathy, Ultrasound scan
Clinical narrative: Enlarged lymph nodes under arm. Liver enzymes abnormal since the vaccines.
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Condition aggravated, Impaired work ability, Migraine, Pain, Photosensitivity reaction
Clinical narrative: I have had severe migraine events for over a week with little to no relief from tylenol, advil, sumatriptan, lidocaine patches, icing painful area. All of my regular ways to abort a migraine have failed for the last week and I have been in severe and unrelenting pain This has disrupted my ability to work. Also I have had photosensitivity.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Emotional disorder, Eye irritation, Fatigue, Feeling abnormal, Glassy eyes
Clinical narrative: I woke up for work the morning after I received the second dose, I could not wake up. I did wake up and felt like I was still asleep, emotionless, like my brain only partially turned on. When I arrived at work at 8:30am, I did not feel right, my eyes started burning and watering, I had sinus problems, I had a headache that went from my nose up to my eyes into my head, I had a 102 degree fever, extremely tired, I was told my eyes looked glossy like I was high. People were talking to me and I was emotionally absent (monotone) , my reaction time was off, people would ask me questions and I had a hard time understanding the question and what to say. I felt ?high? like I had smoked weed or something, my brain was not functioning at normal capacity, I was working and was so embarrassed because I wasn?t on anything, it was the vaccine and that?s why I worked with a fever, because I could not miss work. I had no problems with the first shot, the second was scary, I did not know if my brain was damaged or if it would get better. I will not get another dose after this reaction.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Impaired work ability, Lacrimation increased, Mental impairment, No reaction on previous exposure to drug
Clinical narrative: I woke up for work the morning after I received the second dose, I could not wake up. I did wake up and felt like I was still asleep, emotionless, like my brain only partially turned on. When I arrived at work at 8:30am, I did not feel right, my eyes started burning and watering, I had sinus problems, I had a headache that went from my nose up to my eyes into my head, I had a 102 degree fever, extremely tired, I was told my eyes looked glossy like I was high. People were talking to me and I was emotionally absent (monotone) , my reaction time was off, people would ask me questions and I had a hard time understanding the question and what to say. I felt ?high? like I had smoked weed or something, my brain was not functioning at normal capacity, I was working and was so embarrassed because I wasn?t on anything, it was the vaccine and that?s why I worked with a fever, because I could not miss work. I had no problems with the first shot, the second was scary, I did not know if my brain was damaged or if it would get better. I will not get another dose after this reaction.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sinus disorder, Somnolence
Clinical narrative: I woke up for work the morning after I received the second dose, I could not wake up. I did wake up and felt like I was still asleep, emotionless, like my brain only partially turned on. When I arrived at work at 8:30am, I did not feel right, my eyes started burning and watering, I had sinus problems, I had a headache that went from my nose up to my eyes into my head, I had a 102 degree fever, extremely tired, I was told my eyes looked glossy like I was high. People were talking to me and I was emotionally absent (monotone) , my reaction time was off, people would ask me questions and I had a hard time understanding the question and what to say. I felt ?high? like I had smoked weed or something, my brain was not functioning at normal capacity, I was working and was so embarrassed because I wasn?t on anything, it was the vaccine and that?s why I worked with a fever, because I could not miss work. I had no problems with the first shot, the second was scary, I did not know if my brain was damaged or if it would get better. I will not get another dose after this reaction.
Age: 18.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was with her father. She was receiving Pfizer bivalent vaccine and fluarix and her father was  receiving Shingrix. She was in given Shingrix by the pharmacy intern at 4:20 pm. She was monitored for signs/ symptoms for 20 minutes without incident.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Back pain, Fatigue, Headache, Myalgia
Clinical narrative: Headaches  4 days, fatigue, myalgias Shingles like rash.  Rash in left arm, shoulder and back concomitant w/pain and itchiness of shoulder
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Rash
Clinical narrative: Headaches  4 days, fatigue, myalgias Shingles like rash.  Rash in left arm, shoulder and back concomitant w/pain and itchiness of shoulder
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: Headache, Pain in extremity, Pruritus, Pyrexia, Swelling
Clinical narrative: Arm pain  Swelling Itching  101 fever Headache
Age: 16.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dehydration, Vomiting
Clinical narrative: Extreme vomiting for 12 hours which lead to dehydration
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Diarrhoea, Headache, Injection site pain, Micturition urgency
Clinical narrative: Increase in urinary urgency  Headache Fever Diarrhea  Pain at site Joint pain
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia
Clinical narrative: Increase in urinary urgency  Headache Fever Diarrhea  Pain at site Joint pain
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site warmth, Pain, Pruritus, Swelling
Clinical narrative: patient developed itchy/pain/redness/swelling the day after she received injection, and it is not getting better.  She now experiences hot temperature around the injection site.
Age: 10.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Immediate post-injection reaction, Malaise, Nausea, Vomiting
Clinical narrative: three to four minutes later the patient was lying down on the floor said not feeling well, he said he is sick, he had nausea and then vomited on the floor. I had had him sit down on floor and told him to relax.  he said he never had to get two shots at once, and felt sick.  after few minutes he was well again and he went to restroom with his mother to wash his hand and face.  then they waited in the waiting room for 15 minutes and had water to drink felt better and left.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after daily expiration date
Age: 47.0
Sex: F
Vaccine: UNK
Symptoms: Ageusia, Anosmia, Anxiety, Blood test, Cardiac monitoring
Clinical narrative: Starting the day after the mist, I had nasal congestion, diarrhea, edema, loss of taste and racing heart rate with new episodes of panic attacks.   I had severe nausea, headaches, loss of smell, racing heart rate, anxiety, fatigue and eventually, inability to work.  My physician took me off work for 3+ months and then I returned to work very part-time 3/2021.  I was on disability and received 60% of my pay.  Pay was lost during this time.   Many doctor's appointments completed to monitor heart, urine testing, blood tests, etc.   Eventually, weight increased significantly, anxiety continued, nausea, fatigue, unable to work or function at home.  The most I could do was to work on a puzzle for a short time.  I would take a shower, then need a nap for 3 hours.  I was tired and fatigued, yet my heart rate was racing (resting HR 136).  If I went up the stairs at a slow pace, my heart rate increased to 151- 160 beats per minute.  I was not able to go to church, go to work, go to the store, etc.   The appointments and doctors visits are too numerous to list.  Medical records can be available if necessary.   I was on disability at the time.  I am no longer on disability.
Age: 47.0
Sex: F
Vaccine: UNK
Symptoms: Diarrhoea, Disability, Electrocardiogram ambulatory, Fatigue, Headache
Clinical narrative: Starting the day after the mist, I had nasal congestion, diarrhea, edema, loss of taste and racing heart rate with new episodes of panic attacks.   I had severe nausea, headaches, loss of smell, racing heart rate, anxiety, fatigue and eventually, inability to work.  My physician took me off work for 3+ months and then I returned to work very part-time 3/2021.  I was on disability and received 60% of my pay.  Pay was lost during this time.   Many doctor's appointments completed to monitor heart, urine testing, blood tests, etc.   Eventually, weight increased significantly, anxiety continued, nausea, fatigue, unable to work or function at home.  The most I could do was to work on a puzzle for a short time.  I would take a shower, then need a nap for 3 hours.  I was tired and fatigued, yet my heart rate was racing (resting HR 136).  If I went up the stairs at a slow pace, my heart rate increased to 151- 160 beats per minute.  I was not able to go to church, go to work, go to the store, etc.   The appointments and doctors visits are too numerous to list.  Medical records can be available if necessary.   I was on disability at the time.  I am no longer on disability.
Age: 47.0
Sex: F
Vaccine: UNK
Symptoms: Heart rate increased, Impaired work ability, Laboratory test, Loss of personal independence in daily activities, Nasal congestion
Clinical narrative: Starting the day after the mist, I had nasal congestion, diarrhea, edema, loss of taste and racing heart rate with new episodes of panic attacks.   I had severe nausea, headaches, loss of smell, racing heart rate, anxiety, fatigue and eventually, inability to work.  My physician took me off work for 3+ months and then I returned to work very part-time 3/2021.  I was on disability and received 60% of my pay.  Pay was lost during this time.   Many doctor's appointments completed to monitor heart, urine testing, blood tests, etc.   Eventually, weight increased significantly, anxiety continued, nausea, fatigue, unable to work or function at home.  The most I could do was to work on a puzzle for a short time.  I would take a shower, then need a nap for 3 hours.  I was tired and fatigued, yet my heart rate was racing (resting HR 136).  If I went up the stairs at a slow pace, my heart rate increased to 151- 160 beats per minute.  I was not able to go to church, go to work, go to the store, etc.   The appointments and doctors visits are too numerous to list.  Medical records can be available if necessary.   I was on disability at the time.  I am no longer on disability.
Age: 47.0
Sex: F
Vaccine: UNK
Symptoms: Nausea, Oedema, Panic attack, Urine analysis, Weight increased
Clinical narrative: Starting the day after the mist, I had nasal congestion, diarrhea, edema, loss of taste and racing heart rate with new episodes of panic attacks.   I had severe nausea, headaches, loss of smell, racing heart rate, anxiety, fatigue and eventually, inability to work.  My physician took me off work for 3+ months and then I returned to work very part-time 3/2021.  I was on disability and received 60% of my pay.  Pay was lost during this time.   Many doctor's appointments completed to monitor heart, urine testing, blood tests, etc.   Eventually, weight increased significantly, anxiety continued, nausea, fatigue, unable to work or function at home.  The most I could do was to work on a puzzle for a short time.  I would take a shower, then need a nap for 3 hours.  I was tired and fatigued, yet my heart rate was racing (resting HR 136).  If I went up the stairs at a slow pace, my heart rate increased to 151- 160 beats per minute.  I was not able to go to church, go to work, go to the store, etc.   The appointments and doctors visits are too numerous to list.  Medical records can be available if necessary.   I was on disability at the time.  I am no longer on disability.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Anxiety, Hypoaesthesia oral, Palpitations
Clinical narrative: About two hours after the injection, started having palpitations and a mild feeling of anxiety. Then started having numbness on upper lip. The numb feeling persisted for 6-7 hours. Watched carefully for swelling--did not observe swelling of lip(s). Have never had this reaction with a flu shot or other vaccine. Was concerning because have had severe allergic reactions in the past to spider bites, and injectable iron.
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Heart rate increased, Interchange of vaccine products, Palpitations
Clinical narrative: Severe heart palpitations-suddenly going 150-160 beats per minute multiple times a day, and it lasted several weeks. I did not see a doctor about it. I have had this occur (but not this severe) after each Covid shot. My two originals were Pfizer as was my first booster. My second booster was Moderna, and the bivalent just now was Pfizer.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Electromyogram abnormal, Glycosylated haemoglobin increased, Hyperglycaemia, Impaired work ability
Clinical narrative: I developed acute onset hyperglycemia. On 11/21/21 I was diagnosed with type II diabetes with a fasting glucose of 369 and HbA1C of 9.9.  Subsequently I have also developed acute onset neuropathy of unknown etiology. Neuropathy has continued to worsen over the last year resulting in significant weakness that involve bilateral lower legs and arms resulting in difficulty with work.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Neuropathy peripheral, Type 2 diabetes mellitus
Clinical narrative: I developed acute onset hyperglycemia. On 11/21/21 I was diagnosed with type II diabetes with a fasting glucose of 369 and HbA1C of 9.9.  Subsequently I have also developed acute onset neuropathy of unknown etiology. Neuropathy has continued to worsen over the last year resulting in significant weakness that involve bilateral lower legs and arms resulting in difficulty with work.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Pt was provided with a booster dose of monovalent Pfizer rather than the recommended bivalent product.  Pt not immunocompromised.  No side effects or adverse events occurred.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Autopsy, Cardiac arrest, Death
Clinical narrative: Heart stopped.  Death
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, Nausea, Pain, Pyrexia
Clinical narrative: Breakthrough COVID infection. Admitted for chest and stomach pain beginning 11/14/2022. Positive COVID test collected 11/16/2022. Patient left against medical advice on 11/19/2022.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Vomiting
Clinical narrative: Breakthrough COVID infection. Admitted for chest and stomach pain beginning 11/14/2022. Positive COVID test collected 11/16/2022. Patient left against medical advice on 11/19/2022.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, COVID-19, Chest pain, Influenza virus test, Refusal of treatment by patient
Clinical narrative: Breakthrough COVID infection. Admitted for chest and stomach pain beginning 11/14/2022. Positive COVID test collected 11/16/2022. Patient left against medical advice on 11/19/2022.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Respiratory syncytial virus test, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough COVID infection. Admitted for chest and stomach pain beginning 11/14/2022. Positive COVID test collected 11/16/2022. Patient left against medical advice on 11/19/2022.
Age: 100.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Asymptomatic COVID-19, Fall, SARS-CoV-2 test positive
Clinical narrative: RESIDENT WAS NOTED TO BE UNRESPONSIVE WITH WEAK, THREADY PULSE AND NOTED AGONAL BREATHING. TIME OF DEATH NOTED AT 9:10 AM
Age: 100.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Agonal respiration, Death, Pulse abnormal, Unresponsive to stimuli
Clinical narrative: RESIDENT WAS NOTED TO BE UNRESPONSIVE WITH WEAK, THREADY PULSE AND NOTED AGONAL BREATHING. TIME OF DEATH NOTED AT 9:10 AM
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Antinuclear antibody positive, Arthralgia, Autoimmune disorder, Blood immunoglobulin G decreased
Clinical narrative: Idiosyncratic allergic reaction. Developed severe high blood pressure within a minute and chest and throat tightened. Was given benadryl and transported to Medical Center for evaluation and treatment. I was released a couple hours later after blood pressure normalized.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest discomfort, Crying, Electrocardiogram, Exercise tolerance decreased
Clinical narrative: Idiosyncratic allergic reaction. Developed severe high blood pressure within a minute and chest and throat tightened. Was given benadryl and transported to Medical Center for evaluation and treatment. I was released a couple hours later after blood pressure normalized.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Head discomfort, Hypertension, Idiosyncratic drug reaction, Immunisation reaction
Clinical narrative: Idiosyncratic allergic reaction. Developed severe high blood pressure within a minute and chest and throat tightened. Was given benadryl and transported to Medical Center for evaluation and treatment. I was released a couple hours later after blood pressure normalized.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Immunodeficiency common variable, Immunoglobulin therapy, Inflammation, Lung disorder, Muscular weakness
Clinical narrative: Idiosyncratic allergic reaction. Developed severe high blood pressure within a minute and chest and throat tightened. Was given benadryl and transported to Medical Center for evaluation and treatment. I was released a couple hours later after blood pressure normalized.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropsychiatric symptoms, Nodule, Red blood cell sedimentation rate increased, Scan, Throat tightness
Clinical narrative: Idiosyncratic allergic reaction. Developed severe high blood pressure within a minute and chest and throat tightened. Was given benadryl and transported to Medical Center for evaluation and treatment. I was released a couple hours later after blood pressure normalized.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: hospitalization
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Unevaluable event
Clinical narrative: hospitalization
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No adverse event; Proquad accidentaly administered to a 20 year old patient; This spontaneous report was received from nurse referring to a 20-year-old patient of unknown gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 24-OCT-2022, the patient was accidently administered a measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (product administered to patient of inappropriate age).
Age: 29.0
Sex: M
Vaccine: MMR
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; his first dose of MMR II at the age of 29 years; This spontaneous report was received from a pharmacist referring to a 29-year-old male. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date in 2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) (product administered to patient of inappropriate age).
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; an improperly store PEDVAX that experienced a supported excursion was administered to a patient.; This spontaneous report was received from a nurse and refers to an unknown age and gender patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 28-OCT-2022, the patient was vaccinated with an improperly store haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #U031544, expiration date: 23-JUN-2024, administered intramuscularly (strength, dose, anatomical site injection were not provided) (product storage error), the suspect vaccine was exposed to a temperature of33 degree Fahrenheit for a time frame of 9 minutes. No previous temperature excursion was provided. No adverse event was reported.
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: groin lymph node enlargement after receiving GARDASIL; This spontaneous report has been recieved from a physician regarding an adult female patient. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), intramuscular injection, (strenght, dose, frequency, route of administration, site of vaccination, lot number, and expiration date were not provided) for prophylaxis.  On an unknown date (also reported as more than 10 years ago but less than 15 years ago), the patient (a female in her 20s) experienced groin lymph node enlargement after receiving quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (lymphadenopathy). The reporter was not sure about the valent number of the vaccine administered, or if the event ocurred after the first or the second dose administration. The outcome of the event was not provided.  The causal relationship regarding the event lymphadenopathy and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; PROQUAD that underwent a temperature excursion was administered; This spontaneous report has been received from a registered nurse referring a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 08-NOV-2022, the patient was vaccinated with an improperly stored dose of measles (+) mumps (+) rubella and varicella (oka-merck) virus vaccine live (PROQUAD), subcutaneous Injection, lot number W023865 with expiration date 29-OCT-2023 (product storage error).  The administered dose of the vaccine experienced a temperature excursion of -10 grades celsius (C) up to 8 grades celsius (C) (2.5C) for 1 hour 42 minutes and 0 seconds. No previous temperature excursion happened and there was no additional adverse event reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event occurred; The patient received a dose of GARDASIL 9, but the product expired; This spontaneous report was received from medical assistant referring  to a patient of an unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 10-NOV-2022, the patient was vaccinated with an expired  dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose, lot number s028738, with an expiration date: 03-APR-2022 (strength, dose, anatomical site injection, route of administration  were not provided) (expired product administered). No adverse event occurred.
Sex: F
Vaccine: VARZOS
Symptoms: Skin lesion
Clinical narrative: a lesion on her leg; Information has been received regarding a case in litigation from a lawyer and referred to a female patient (pt) of unknown age. No information was provided regarding the pt's medical history, allergies, drug reactions, concurrent conditions or concomitant medications.  On an unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, lot number and expiration date were unknown) vaccine for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).   On unknown date (reported as after receiving suspect vaccine), the pt suffered a lesion on her leg. As a result of those symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of suspect vaccine, the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of suspect vaccine, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of suspect vaccine, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered as not recovered. The causality assessment between the event and suspect vaccine was related.  The event was considered to be disability by the reporter.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: HCP reporting an improperly stored vaccine was administered to a patient.; This spontaneous report was received from a medical assistant and refers to a unspecified age and gender patient. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On 08-NOV-2022, the patient was vaccinated with an improper storage dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA(M-M-R II) subcutaneous injection, lot number U039910, expiration date: 16-DEC-2023 who had been verified to be a valid number, administered for prophylaxis (strength,dose and anatomical site of injection were not provided). The vaccine was storage at temperature of 47.83 degree Fahrenheit, with a time frame of 0 hours 10 minutes and 0 seconds. There was no information about previous temperature excursion.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Nurse calling to report that a vaccine was administered after its expiration date.; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 11-NOV-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) (rHA) virus vaccine, live (M-M-R II) at a dose of 0.5 milliliters (lot T037028 has been verified to be a valid, expiration date 03-NOV-2022, and upon internal validation established as the same date) for prophylaxis (vaccination scheme, frequency, route of administration, and anatomical site of injection were not reported (expired product administered).
Age: 0.83
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; Nurse reports a 10 months 4 days old patient was accidently administered ROTATEQ on Nov 15, 2022.; received the last dose of ROTATEQ later than suppose too; This spontaneous report has been received from registered nurse referring a 10 months 4 days patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 15-NOV-2022, the patient was accidentally administered with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, once, lot number W002562 with expiration date 12-OCT-2023 (strength, vaccination scheme, route of administration and anatomical site of application were not provided) (inappropriate schedule of product administration, product administered to patient of inappropriate age). No additional adverse event reported.
Age: 1.08
Sex: M
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Customer reported expired RECOMBIVAX HB got administered to a patient today (11/15/2022). No additional AE reported. No PQC reported. No further information was provided.; This spontaneous report was received from a nurse, referring to a 13-month-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 15-NOV-2022, the patient was vaccinated with an expired dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported; lot number T032918, expiration date reported and validated as 12-NOV-2022) as prophylaxis (expired product administered). No additional adverse event reported.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash across her back; This case was reported by a consumer via call center representative and described the occurrence of rash in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th November 2022, the patient received the 1st dose of Shingrix. In November 2022, less than a week after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 15-NOV-2022 Reporter's comment: The patient self-reported this case. The patient received dose of Shingrix vaccine and now she was experiencing a rash across her back. The reporter consented to follow-up.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Redness on left arm injection site since 2nd primary dose; Tenderness on left arm injection site since 2nd primary dose/Left Arm Injection Site getting worst specially if she squeezes it; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness on left arm injection site since 2nd primary dose) and VACCINATION SITE PAIN (Tenderness on left arm injection site since 2nd primary dose/Left Arm Injection Site getting worst specially if she squeezes it) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness on left arm injection site since 2nd primary dose) and VACCINATION SITE PAIN (Tenderness on left arm injection site since 2nd primary dose/Left Arm Injection Site getting worst specially if she squeezes it). At the time of the report, VACCINATION SITE ERYTHEMA (Redness on left arm injection site since 2nd primary dose) and VACCINATION SITE PAIN (Tenderness on left arm injection site since 2nd primary dose/Left Arm Injection Site getting worst specially if she squeezes it) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Since 2nd primary dose on 21-May-2021, she has redness and tenderness on injection site left arm. The arm was getting worst specially if she squeezes it. Patient was planning on seeing a doctor and has not reported to VAERS yet. As per the pharmacist, the patient has not received any other shots in the left arm since the second primary Moderna COVID-19 shot on 21-May-2021.  No treatment medications were reported.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid 19; This spontaneous case was reported by an other caregiver and describes the occurrence of COVID-19 (Covid 19) in a 24-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In November 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 16-Nov-2022, the patient experienced COVID-19 (Covid 19). At the time of the report, COVID-19 (Covid 19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Nov-2022, SARS-CoV-2 test: Positive.         No concomitant medications were reported. The patient got the Moderna Bivalent booster last week on Thursday. It was reported that the patient had a cough that was not going away with their inhaler. No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Joint swelling, Peripheral swelling
Clinical narrative: redness at right wrist and hand; swelling at right wrist; swelling at hand; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (redness at right wrist and hand), JOINT SWELLING (swelling at right wrist) and PERIPHERAL SWELLING (swelling at hand) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (redness at right wrist and hand), JOINT SWELLING (swelling at right wrist) and PERIPHERAL SWELLING (swelling at hand). At the time of the report, ERYTHEMA (redness at right wrist and hand), JOINT SWELLING (swelling at right wrist) and PERIPHERAL SWELLING (swelling at hand) outcome was unknown.            Concomitant medications were not reported. It was reported that patient received 4 doses and the latest booster of Moderna and wanted to know the possibilities of side effects. Treatment medications were not provided.   Reporter did not allow further contact