chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: U
Vaccine: COVID19
Symptoms: Platelet count decreased, Pyrexia
Clinical narrative: Chief Complaint: abnl labs   HPI: 47-year-old male with history of illness with idiopathic neutropenia around age 12 (records not available, per patient had no diagnosis with bone marrow biopsy),  in childhood, eczema, atopic dermatitis, obesity, hypertriglyceridemia, current smoker, OSA.  Outpatient lab checks in 2018 and 2019 showed platelets of 88 and 96 K respectively. He had a febrile flu like illness in early February with negative covid 19 test and recovered well. About a week ago he was moving a pergola with is hands over his head and then developed a lump on his LUQ abd wall. On 2/23 he saw his PCP regarding the left abdominal mass. Outpatient labs found plts of 2K. He was directed to the local ED and labs were normal other than plts of 1K. He endorsed gum bleeding with tooth brushing 1 week prior. He has a few spontaneous bruises on his legs and neck and abdomen.    Baseline Mobility: independent of ADLs
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Bacteraemia, Bacterial test positive, Blood culture positive, COVID-19
Clinical narrative: Patient is a 94 Y female with history of hypertension, HFpEF, seizure, left eye blindness, Covid19 (+) 12/20/2022.    Recently admitted 2/6 - 2/16/2023 for melena.  EGD on 2/6/2023 - severe esophagitis, type 1 hiatal hernia, 4 duodenal ulcers.  2) anemia due to GI bleed s/p total of 2 units prbc, 3) bacteremia - blood cultures 1/2 sets collect 2/6 +Eubacterium lentum, ruminococcus gnavus, clostridium species.  Pt was discharged home with Protonix and Vantin/Flagyl to complete 2 weeks of antibiotics.   Covid19 swab (-) on 2/6/2023. Reported pt has already developed some mild cough during last hospitalization.     Patient was sent to the ED when home health RN checked o2 sat = 81% and pt appeared to have some shortness of breath.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Clostridial infection, Clostridium test positive, Cough, Duodenal ulcer, Dyspnoea
Clinical narrative: Patient is a 94 Y female with history of hypertension, HFpEF, seizure, left eye blindness, Covid19 (+) 12/20/2022.    Recently admitted 2/6 - 2/16/2023 for melena.  EGD on 2/6/2023 - severe esophagitis, type 1 hiatal hernia, 4 duodenal ulcers.  2) anemia due to GI bleed s/p total of 2 units prbc, 3) bacteremia - blood cultures 1/2 sets collect 2/6 +Eubacterium lentum, ruminococcus gnavus, clostridium species.  Pt was discharged home with Protonix and Vantin/Flagyl to complete 2 weeks of antibiotics.   Covid19 swab (-) on 2/6/2023. Reported pt has already developed some mild cough during last hospitalization.     Patient was sent to the ED when home health RN checked o2 sat = 81% and pt appeared to have some shortness of breath.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Eubacterium infection, Gastrointestinal haemorrhage, Hiatus hernia, Melaena, Oesophagitis
Clinical narrative: Patient is a 94 Y female with history of hypertension, HFpEF, seizure, left eye blindness, Covid19 (+) 12/20/2022.    Recently admitted 2/6 - 2/16/2023 for melena.  EGD on 2/6/2023 - severe esophagitis, type 1 hiatal hernia, 4 duodenal ulcers.  2) anemia due to GI bleed s/p total of 2 units prbc, 3) bacteremia - blood cultures 1/2 sets collect 2/6 +Eubacterium lentum, ruminococcus gnavus, clostridium species.  Pt was discharged home with Protonix and Vantin/Flagyl to complete 2 weeks of antibiotics.   Covid19 swab (-) on 2/6/2023. Reported pt has already developed some mild cough during last hospitalization.     Patient was sent to the ED when home health RN checked o2 sat = 81% and pt appeared to have some shortness of breath.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Oesophagogastroduodenoscopy abnormal, Red blood cell transfusion, SARS-CoV-2 test positive
Clinical narrative: Patient is a 94 Y female with history of hypertension, HFpEF, seizure, left eye blindness, Covid19 (+) 12/20/2022.    Recently admitted 2/6 - 2/16/2023 for melena.  EGD on 2/6/2023 - severe esophagitis, type 1 hiatal hernia, 4 duodenal ulcers.  2) anemia due to GI bleed s/p total of 2 units prbc, 3) bacteremia - blood cultures 1/2 sets collect 2/6 +Eubacterium lentum, ruminococcus gnavus, clostridium species.  Pt was discharged home with Protonix and Vantin/Flagyl to complete 2 weeks of antibiotics.   Covid19 swab (-) on 2/6/2023. Reported pt has already developed some mild cough during last hospitalization.     Patient was sent to the ED when home health RN checked o2 sat = 81% and pt appeared to have some shortness of breath.
Age: 76.0
Sex: M
Vaccine: PNC20
Symptoms: Arthralgia, Blood pressure increased, Contusion, Fatigue, Weight increased
Clinical narrative: Joint pain, weight gain, blood pressure spiking, black and blue bruises without prior injury, extreme fatigue
Age: 39.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Chest pain, Dyspnoea, Dyspnoea exertional, Exercise tolerance decreased, Post-acute COVID-19 syndrome
Clinical narrative: I had long COVID syndrome. I couldn't breathe properly and couldn't get enough air in my lungs. I was so winded from doing any activities in the house. I tried to exercise and I would get chest pain. When I tried to catch my breath or cough, I would cough up a watery substance. I went to the urgent care and they gave me an albuterol inhaler, cough syrup, and steroid pack.
Age: 39.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Productive cough
Clinical narrative: I had long COVID syndrome. I couldn't breathe properly and couldn't get enough air in my lungs. I was so winded from doing any activities in the house. I tried to exercise and I would get chest pain. When I tried to catch my breath or cough, I would cough up a watery substance. I went to the urgent care and they gave me an albuterol inhaler, cough syrup, and steroid pack.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site nodule, Injection site swelling
Clinical narrative: Patient reported to the pharmacy today that she still felt like her arm swells up and forms a not at the site of injection. Patient was advised to contacther PCP
Age: 53.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Arthralgia, Chills, Decreased appetite, Dry throat, Fatigue
Clinical narrative: severe persistent deep muscle (almost like bone) ache, headache, chills so bad scared to even take a hot shower,, low grade fever (100.1 max), malaise, fatigue, joint ache, intermittent sharp muscle twinges, absolute loss of appetite, dry cracked throat, aversion to sound. unable to perform basic activities of daily living......taking motrin 600 - 800mg three times a day, this is the third day........horrible horrible experience i believe from the shingles vaccine. had the tdap vaccine in the past without any issues.
Age: 53.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Fear, Headache, Hyperacusis, Loss of personal independence in daily activities, Malaise
Clinical narrative: severe persistent deep muscle (almost like bone) ache, headache, chills so bad scared to even take a hot shower,, low grade fever (100.1 max), malaise, fatigue, joint ache, intermittent sharp muscle twinges, absolute loss of appetite, dry cracked throat, aversion to sound. unable to perform basic activities of daily living......taking motrin 600 - 800mg three times a day, this is the third day........horrible horrible experience i believe from the shingles vaccine. had the tdap vaccine in the past without any issues.
Age: 53.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Muscle twitching, Myalgia, Throat irritation
Clinical narrative: severe persistent deep muscle (almost like bone) ache, headache, chills so bad scared to even take a hot shower,, low grade fever (100.1 max), malaise, fatigue, joint ache, intermittent sharp muscle twinges, absolute loss of appetite, dry cracked throat, aversion to sound. unable to perform basic activities of daily living......taking motrin 600 - 800mg three times a day, this is the third day........horrible horrible experience i believe from the shingles vaccine. had the tdap vaccine in the past without any issues.
Age: 67.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Cerebrovascular accident
Clinical narrative: Patient's wife states that she woke up next to her husband 2 days post vaccination and realized he was having a stroke. He was immediately hospitalized.
Age: 22.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event, Product administration error
Clinical narrative: On 1/3/23, patient was supposed to receive Moderna monovalent COVID vaccine as 1st dose of primary series, but she inadvertently received Moderna bivalent COVID vaccine. Patient ended up receiving the 1st primary Moderna monovalent dose on 2/6/23. No adverse event, this is reported as administration error.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity, X-ray
Clinical narrative: Patient stated having arm pain for months after, unable to lift arm
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electric shock sensation, Fatigue, Headache, Injection site pain
Clinical narrative: Extreme fatigue and low grade fever beginning evening of vaccination. Significant pain at injection site the following morning, throbbing sensation radiating into shoulder and neck area. Unable to lift left arm above chest level without   sharp "electric shock" feeling, tingling in fingers. Fatigue and fever increased accompanied by the onset of headache, nausea and  light headedness later in the day.  Through the day and persisted for another 48 hours. Pain on elevation arm remains present for two months.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Nausea, Pain, Paraesthesia, Pyrexia
Clinical narrative: Extreme fatigue and low grade fever beginning evening of vaccination. Significant pain at injection site the following morning, throbbing sensation radiating into shoulder and neck area. Unable to lift left arm above chest level without   sharp "electric shock" feeling, tingling in fingers. Fatigue and fever increased accompanied by the onset of headache, nausea and  light headedness later in the day.  Through the day and persisted for another 48 hours. Pain on elevation arm remains present for two months.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Sensory disturbance
Clinical narrative: Extreme fatigue and low grade fever beginning evening of vaccination. Significant pain at injection site the following morning, throbbing sensation radiating into shoulder and neck area. Unable to lift left arm above chest level without   sharp "electric shock" feeling, tingling in fingers. Fatigue and fever increased accompanied by the onset of headache, nausea and  light headedness later in the day.  Through the day and persisted for another 48 hours. Pain on elevation arm remains present for two months.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Redness around injection site
Age: 38.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Erythema, Heart rate increased, Hyperhidrosis, Nervousness
Clinical narrative: Patient did not experience a true  allergic reactions they had a panic attack.   Panic attack symptoms experienced by patient  : vomiting, sweating, dizziness, redness develop on the back of neck and parts of face, increased heart rate  Patient had a panic attack after receiving vaccine they where nervous of switching to Pfizer from Moderna. Patient stated they want Pfizer but have a fear of needles. After about 10 minutes patient had dizziness and vomiting.   We were about to administer Epi pen but patient stopped and stated no its not an allergic reaction. We called 911 and they asked about symptoms while we where on the phone. Patient started to return back to normal within a few minutes and canceled emergency vehicle.  Injection site was also checked and patient injection site was clear with not redness or signs or rash  Patient was monitored for an additional 30 minutes and patient was back to normal with no symptoms present.
Age: 38.0
Sex: M
Vaccine: COVID19-2
Symptoms: Panic attack, Vomiting
Clinical narrative: Patient did not experience a true  allergic reactions they had a panic attack.   Panic attack symptoms experienced by patient  : vomiting, sweating, dizziness, redness develop on the back of neck and parts of face, increased heart rate  Patient had a panic attack after receiving vaccine they where nervous of switching to Pfizer from Moderna. Patient stated they want Pfizer but have a fear of needles. After about 10 minutes patient had dizziness and vomiting.   We were about to administer Epi pen but patient stopped and stated no its not an allergic reaction. We called 911 and they asked about symptoms while we where on the phone. Patient started to return back to normal within a few minutes and canceled emergency vehicle.  Injection site was also checked and patient injection site was clear with not redness or signs or rash  Patient was monitored for an additional 30 minutes and patient was back to normal with no symptoms present.
Sex: U
Vaccine: COVID19-2
Symptoms: Chills, Headache, Hypoaesthesia, Illness, Influenza
Clinical narrative: 4 days after vaccine, started to feel really sick (fever, nausea, chills, muscle pain, headache), then later in the day my left foot started to develop a tingling sensation that turned into my foot becoming numb in the toes and the bottom of the foot. Sharp tingling pain in left foot every once in a while. If standing or walking for long periods of time, my foot starts to ache along the part where toes are attached (mid met?). While the flu/sickness symptoms went away on 2/20/23, my left foot is still numb and tingling. I went to urgent care today (2/24/2023), and the doctor there diagnosed me with nerve damage and then prescribed me non-steroid anti-inflammation medicine for 10 days to see if symptoms would subside. I was told if symptoms did not go away in 10 days, I would need to see a neurologist. At this time, my left foot is still numb/tingly/aching.
Sex: U
Vaccine: COVID19-2
Symptoms: Malaise, Myalgia, Nausea, Nerve injury, Pain in extremity
Clinical narrative: 4 days after vaccine, started to feel really sick (fever, nausea, chills, muscle pain, headache), then later in the day my left foot started to develop a tingling sensation that turned into my foot becoming numb in the toes and the bottom of the foot. Sharp tingling pain in left foot every once in a while. If standing or walking for long periods of time, my foot starts to ache along the part where toes are attached (mid met?). While the flu/sickness symptoms went away on 2/20/23, my left foot is still numb and tingling. I went to urgent care today (2/24/2023), and the doctor there diagnosed me with nerve damage and then prescribed me non-steroid anti-inflammation medicine for 10 days to see if symptoms would subside. I was told if symptoms did not go away in 10 days, I would need to see a neurologist. At this time, my left foot is still numb/tingly/aching.
Sex: U
Vaccine: COVID19-2
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: 4 days after vaccine, started to feel really sick (fever, nausea, chills, muscle pain, headache), then later in the day my left foot started to develop a tingling sensation that turned into my foot becoming numb in the toes and the bottom of the foot. Sharp tingling pain in left foot every once in a while. If standing or walking for long periods of time, my foot starts to ache along the part where toes are attached (mid met?). While the flu/sickness symptoms went away on 2/20/23, my left foot is still numb and tingling. I went to urgent care today (2/24/2023), and the doctor there diagnosed me with nerve damage and then prescribed me non-steroid anti-inflammation medicine for 10 days to see if symptoms would subside. I was told if symptoms did not go away in 10 days, I would need to see a neurologist. At this time, my left foot is still numb/tingly/aching.
Age: 0.5
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient received an expired vaccine. The label on the vaccine, and online Moderna website had conflicting discharge dates. Call placed  Moderna case opened. Call to mother notified of Moderna suggested options. Mother will call the pediatrician to decide if she will repeat the first dose or continue to the second dose. Mom reports the patient is doing well, tolerated the vaccine well, No s/s of adverse reactions.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac function test normal, Chest pain, Communication disorder, Joint stiffness, Musculoskeletal stiffness
Clinical narrative: Extreme chest pain causing stiffness in the neck and jaw inability to communicate during episodes.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Developed Tinnitus in the left ear , this condition happened after more than a year or so.
Age: 53.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects. Patient was given HPV Gardasil first dose at the age of 53 even though CDC only recommends up to age 45. Patient states his PCP requested that he obtain the vaccine. Patient displayed no symptoms.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Aspiration bone marrow, Blood immunoglobulin M, Blood test, Burning sensation
Clinical narrative: After my second vaccine shot I got very sick with the next symptoms: fever, bad headache, joint pain, muscle pain, skin rash, burning feet and hands, stabbing pain in my calves.  After 24 hours most symptoms disappeared but burning feet and hands left. I started experience suddenly stabbing shots in my right calve. I was afraid of blood clots and went to check my veins. I had varicose veins ablations in 2010. Doctor checked my veins on both legs and said there is nothing wrong with the veins. She advised me visit neurologist, and assumed a neuropathy. I visited many doctors multiple times. I was diagnosed by Neurologist with peripheral neuropathy, by Oncologist with MGUS, he is still in research. Doctor prescribed me Duloxetine to help me sleep, though I still suffer from constant burning pain in my leg and hands. I already have balance problem and almost constant dizziness. No one can find what causes my neuropathy. X-Ray, MRI, PET, blood work. I was pretty healthy before VAX.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Differential white blood cell count, Full blood count, Headache, Hypergammaglobulinaemia benign monoclonal, Immunoglobulins
Clinical narrative: After my second vaccine shot I got very sick with the next symptoms: fever, bad headache, joint pain, muscle pain, skin rash, burning feet and hands, stabbing pain in my calves.  After 24 hours most symptoms disappeared but burning feet and hands left. I started experience suddenly stabbing shots in my right calve. I was afraid of blood clots and went to check my veins. I had varicose veins ablations in 2010. Doctor checked my veins on both legs and said there is nothing wrong with the veins. She advised me visit neurologist, and assumed a neuropathy. I visited many doctors multiple times. I was diagnosed by Neurologist with peripheral neuropathy, by Oncologist with MGUS, he is still in research. Doctor prescribed me Duloxetine to help me sleep, though I still suffer from constant burning pain in my leg and hands. I already have balance problem and almost constant dizziness. No one can find what causes my neuropathy. X-Ray, MRI, PET, blood work. I was pretty healthy before VAX.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test abnormal, Light chain analysis, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Malaise
Clinical narrative: After my second vaccine shot I got very sick with the next symptoms: fever, bad headache, joint pain, muscle pain, skin rash, burning feet and hands, stabbing pain in my calves.  After 24 hours most symptoms disappeared but burning feet and hands left. I started experience suddenly stabbing shots in my right calve. I was afraid of blood clots and went to check my veins. I had varicose veins ablations in 2010. Doctor checked my veins on both legs and said there is nothing wrong with the veins. She advised me visit neurologist, and assumed a neuropathy. I visited many doctors multiple times. I was diagnosed by Neurologist with peripheral neuropathy, by Oncologist with MGUS, he is still in research. Doctor prescribed me Duloxetine to help me sleep, though I still suffer from constant burning pain in my leg and hands. I already have balance problem and almost constant dizziness. No one can find what causes my neuropathy. X-Ray, MRI, PET, blood work. I was pretty healthy before VAX.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Metabolic function test, Myalgia, Neuropathy peripheral, Pain in extremity, Pathology test
Clinical narrative: After my second vaccine shot I got very sick with the next symptoms: fever, bad headache, joint pain, muscle pain, skin rash, burning feet and hands, stabbing pain in my calves.  After 24 hours most symptoms disappeared but burning feet and hands left. I started experience suddenly stabbing shots in my right calve. I was afraid of blood clots and went to check my veins. I had varicose veins ablations in 2010. Doctor checked my veins on both legs and said there is nothing wrong with the veins. She advised me visit neurologist, and assumed a neuropathy. I visited many doctors multiple times. I was diagnosed by Neurologist with peripheral neuropathy, by Oncologist with MGUS, he is still in research. Doctor prescribed me Duloxetine to help me sleep, though I still suffer from constant burning pain in my leg and hands. I already have balance problem and almost constant dizziness. No one can find what causes my neuropathy. X-Ray, MRI, PET, blood work. I was pretty healthy before VAX.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Rash, Scan with contrast, Spinal X-ray, Varicose vein operation
Clinical narrative: After my second vaccine shot I got very sick with the next symptoms: fever, bad headache, joint pain, muscle pain, skin rash, burning feet and hands, stabbing pain in my calves.  After 24 hours most symptoms disappeared but burning feet and hands left. I started experience suddenly stabbing shots in my right calve. I was afraid of blood clots and went to check my veins. I had varicose veins ablations in 2010. Doctor checked my veins on both legs and said there is nothing wrong with the veins. She advised me visit neurologist, and assumed a neuropathy. I visited many doctors multiple times. I was diagnosed by Neurologist with peripheral neuropathy, by Oncologist with MGUS, he is still in research. Doctor prescribed me Duloxetine to help me sleep, though I still suffer from constant burning pain in my leg and hands. I already have balance problem and almost constant dizziness. No one can find what causes my neuropathy. X-Ray, MRI, PET, blood work. I was pretty healthy before VAX.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Balance disorder, Burning sensation, Dizziness, Headache
Clinical narrative: After my second vaccine shot I got very sick with the next symptoms: fever, bad headache, joint pain, muscle pain, skin rash, burning feet and hands, stabbing pain in my calves.  After 24 hours most symptoms disappeared but burning feet and hands left. I started experience suddenly stabbing shots in my right calve. I was afraid of blood clots and went to check my veins. I had varicose veins ablations in 2010. Doctor checked my veins on both legs and said there is nothing wrong with the veins. She advised me visit neurologist, and assumed a neuropathy. I visited many doctors multiple times. I was diagnosed by Neurologist with peripheral neuropathy, by Oncologist with MGUS, he is still in research. Doctor prescribed me Duloxetine to help me sleep, though I still suffer from constant burning pain in my leg and hands. I already have balance problem and almost constant dizziness. No one can find what causes my neuropathy. X-Ray, MRI, PET, blood work. I was pretty healthy before VAX.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Illness, Investigation, Magnetic resonance imaging, Myalgia, Neuropathy peripheral
Clinical narrative: After my second vaccine shot I got very sick with the next symptoms: fever, bad headache, joint pain, muscle pain, skin rash, burning feet and hands, stabbing pain in my calves.  After 24 hours most symptoms disappeared but burning feet and hands left. I started experience suddenly stabbing shots in my right calve. I was afraid of blood clots and went to check my veins. I had varicose veins ablations in 2010. Doctor checked my veins on both legs and said there is nothing wrong with the veins. She advised me visit neurologist, and assumed a neuropathy. I visited many doctors multiple times. I was diagnosed by Neurologist with peripheral neuropathy, by Oncologist with MGUS, he is still in research. Doctor prescribed me Duloxetine to help me sleep, though I still suffer from constant burning pain in my leg and hands. I already have balance problem and almost constant dizziness. No one can find what causes my neuropathy. X-Ray, MRI, PET, blood work. I was pretty healthy before VAX.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Positron emission tomogram, Pyrexia, Rash, Sleep disorder
Clinical narrative: After my second vaccine shot I got very sick with the next symptoms: fever, bad headache, joint pain, muscle pain, skin rash, burning feet and hands, stabbing pain in my calves.  After 24 hours most symptoms disappeared but burning feet and hands left. I started experience suddenly stabbing shots in my right calve. I was afraid of blood clots and went to check my veins. I had varicose veins ablations in 2010. Doctor checked my veins on both legs and said there is nothing wrong with the veins. She advised me visit neurologist, and assumed a neuropathy. I visited many doctors multiple times. I was diagnosed by Neurologist with peripheral neuropathy, by Oncologist with MGUS, he is still in research. Doctor prescribed me Duloxetine to help me sleep, though I still suffer from constant burning pain in my leg and hands. I already have balance problem and almost constant dizziness. No one can find what causes my neuropathy. X-Ray, MRI, PET, blood work. I was pretty healthy before VAX.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: X-ray
Clinical narrative: After my second vaccine shot I got very sick with the next symptoms: fever, bad headache, joint pain, muscle pain, skin rash, burning feet and hands, stabbing pain in my calves.  After 24 hours most symptoms disappeared but burning feet and hands left. I started experience suddenly stabbing shots in my right calve. I was afraid of blood clots and went to check my veins. I had varicose veins ablations in 2010. Doctor checked my veins on both legs and said there is nothing wrong with the veins. She advised me visit neurologist, and assumed a neuropathy. I visited many doctors multiple times. I was diagnosed by Neurologist with peripheral neuropathy, by Oncologist with MGUS, he is still in research. Doctor prescribed me Duloxetine to help me sleep, though I still suffer from constant burning pain in my leg and hands. I already have balance problem and almost constant dizziness. No one can find what causes my neuropathy. X-Ray, MRI, PET, blood work. I was pretty healthy before VAX.
Age: 20.0
Sex: F
Vaccine: COVID19-2
Symptoms: Malaise, Pallor, Syncope
Clinical narrative: About 5 minutes after receiving Pfizer bivalent vaccination patient approached counter and reported not feeling well. She looked very pale and with assistance sat down and then laid down to the floor(fainted). She may not have completely lost consciousness but closed her eyes. She was able to talk with me and gradually came around over 5 to 10 minutes where she was then able to sit up. Patient was picked up at  the store after about 25 minutes of observation.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Magnetic resonance imaging, Mobility decreased, Monoplegia, Muscular weakness
Clinical narrative: Arm has been an extreme pain and now it is paralyzed fingers and arm. Left leg is weak very very weak I have fallen several times and couldn't get up because I can only use one arm
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Ultrasound scan
Clinical narrative: Arm has been an extreme pain and now it is paralyzed fingers and arm. Left leg is weak very very weak I have fallen several times and couldn't get up because I can only use one arm
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Headache, Myalgia, Nausea
Clinical narrative: Adverse events: muscles aches, chest pains, nauseau, dizziness and headaches  Treatment: hospitalization, prescribed colchicine upon release Outcome: 2 month follow-up appointment signaled nothing note-worthy; on and off chest pain since the event
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Angiogram, Blood creatine phosphokinase, Cardiac failure acute, Coronary artery occlusion, Dyspnoea
Clinical narrative: He developed acute heart failure, renal failure, rhabdomyolysis, elevated LFTs, thrombocytopenia.  Seen initially in outpatient clinic for SOB that was attributed to COPD and skinning coyotes, then had repeated visits for worsening SOB and ultimately to outside ED for worsening edema and hypoxemia with subsequent transfer and admission to our facility requiring non-invasive vent support.  Started on continuous renal replacement therapy (CRRT).  Found to have global hypokinesis and severe L main coronary blockage and underwent complex PCI intervention, then developed post procedural hematoma with persistent acute thrombocytopenia since admit.  Fem stop placed and bleeding controlled, but he developed worsening shock in the setting of multiorgan failure and ultimately transitioned to comfort care.
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Echocardiogram, Full blood count, Haemofiltration, Hypoxia, Liver function test increased
Clinical narrative: He developed acute heart failure, renal failure, rhabdomyolysis, elevated LFTs, thrombocytopenia.  Seen initially in outpatient clinic for SOB that was attributed to COPD and skinning coyotes, then had repeated visits for worsening SOB and ultimately to outside ED for worsening edema and hypoxemia with subsequent transfer and admission to our facility requiring non-invasive vent support.  Started on continuous renal replacement therapy (CRRT).  Found to have global hypokinesis and severe L main coronary blockage and underwent complex PCI intervention, then developed post procedural hematoma with persistent acute thrombocytopenia since admit.  Fem stop placed and bleeding controlled, but he developed worsening shock in the setting of multiorgan failure and ultimately transitioned to comfort care.
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Mechanical ventilation, Metabolic function test, Multiple organ dysfunction syndrome, Oedema, Percutaneous coronary intervention
Clinical narrative: He developed acute heart failure, renal failure, rhabdomyolysis, elevated LFTs, thrombocytopenia.  Seen initially in outpatient clinic for SOB that was attributed to COPD and skinning coyotes, then had repeated visits for worsening SOB and ultimately to outside ED for worsening edema and hypoxemia with subsequent transfer and admission to our facility requiring non-invasive vent support.  Started on continuous renal replacement therapy (CRRT).  Found to have global hypokinesis and severe L main coronary blockage and underwent complex PCI intervention, then developed post procedural hematoma with persistent acute thrombocytopenia since admit.  Fem stop placed and bleeding controlled, but he developed worsening shock in the setting of multiorgan failure and ultimately transitioned to comfort care.
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Post procedural haematoma, Renal failure, Rhabdomyolysis, Shock, Thrombocytopenia
Clinical narrative: He developed acute heart failure, renal failure, rhabdomyolysis, elevated LFTs, thrombocytopenia.  Seen initially in outpatient clinic for SOB that was attributed to COPD and skinning coyotes, then had repeated visits for worsening SOB and ultimately to outside ED for worsening edema and hypoxemia with subsequent transfer and admission to our facility requiring non-invasive vent support.  Started on continuous renal replacement therapy (CRRT).  Found to have global hypokinesis and severe L main coronary blockage and underwent complex PCI intervention, then developed post procedural hematoma with persistent acute thrombocytopenia since admit.  Fem stop placed and bleeding controlled, but he developed worsening shock in the setting of multiorgan failure and ultimately transitioned to comfort care.
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Ventricular hypokinesia
Clinical narrative: He developed acute heart failure, renal failure, rhabdomyolysis, elevated LFTs, thrombocytopenia.  Seen initially in outpatient clinic for SOB that was attributed to COPD and skinning coyotes, then had repeated visits for worsening SOB and ultimately to outside ED for worsening edema and hypoxemia with subsequent transfer and admission to our facility requiring non-invasive vent support.  Started on continuous renal replacement therapy (CRRT).  Found to have global hypokinesis and severe L main coronary blockage and underwent complex PCI intervention, then developed post procedural hematoma with persistent acute thrombocytopenia since admit.  Fem stop placed and bleeding controlled, but he developed worsening shock in the setting of multiorgan failure and ultimately transitioned to comfort care.
Age: 3.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Mom came to the pharmacy to request Covid shot for her daughter. However, when pharmacist asked her if it would be the booster dose, Mom confirmed it was in another language. Patient returned after 3 weeks for her second dose. Pharmacist found out the patient had never had any primary dose before.   Mom reported the child did not have any adverse events after the booster dose..
Age: 3.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Chills, Incorrect product formulation administered, Influenza
Clinical narrative: Mom came to the pharmacy to request Covid shot for her daughter. However, when pharmacist asked her if it would be the booster dose, Mom confirmed it was in another language. Patient returned after 3 weeks for her second dose. Pharmacist found out the patient had never had any primary dose before.   Mom reported the child did not have any adverse events after the booster dose..
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Peripheral swelling, Pruritus, Rash erythematous, Skin discolouration
Clinical narrative: Called MD on call. Swelling & hives hands & arms bil. Were starting to look purple. Face & body five red bumps, itchy feet bright red. Took Allegra & went to ER. as advised
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Streptococcus test negative, Urticaria
Clinical narrative: Called MD on call. Swelling & hives hands & arms bil. Were starting to look purple. Face & body five red bumps, itchy feet bright red. Took Allegra & went to ER. as advised
Sex: U
Vaccine: PNC20
Symptoms: Device physical property issue, Poor quality device used
Clinical narrative: When closing the safety cap, the syringe is breaking at the neck post vaccination; post vaccination when the issue occurred with the syringe; When closing the safety cap, the syringe is breaking at the neck post vaccination; post vaccination when the issue occurred with the syringe; This is a spontaneous report received from a contactable healthcare professional from product quality group.  A patient (no qualifiers provided) received pneumococcal 20-valent conjugate vaccine (Diphtheria CRM 197 Protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY DEVICE USED (non-serious), DEVICE PHYSICAL PROPERTY ISSUE (non-serious) and all described as "When closing the safety cap, the syringe is breaking at the neck post vaccination; post vaccination when the issue occurred with the syringe".  Additional Information: The healthcare professional was calling to report an issue that was reported to her about the syringe for PREVNAR 20. When closing the safety cap, the syringe is breaking at the neck post vaccination. This is occurring after the product is used. When they are closing the safety cap it is breaking. It happened to at least 10 prefilled syringes. There was no issue with administering the vaccine itself. It was post vaccination when the issue occurred with the syringe.   The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (Diphtheria CRM 197 Protein) has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 27Nov2021 as dose 3 (booster), single, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 29Dec2020 as dose 1, single (Batch/Lot number: unknown), on 08Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 26Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cardiomyopathy" (unspecified if ongoing); "known allergies Ace inhibitors" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient took nirmatrelvir, ritonavir (PAXLOVID) via oral route from 09Feb2023 to 13Feb2023 as treatment of COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events drug ineffective and Covid-19 are related to BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5) and BNT162b2 (BNT162B2) cannot be excluded. This case will be reassessed should additional information become available.,Linked Report(s) : US-PFIZER INC-202300076435 same patient, different vaccine dose/event;
Age: 34.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19, COVID19-2
Symptoms: Brain injury, Cardiomyopathy, Dyspnoea, SARS-CoV-2 test
Clinical narrative: cardiomyopathy; anoxic brain damage; had trouble breathing stating she felt she had something in her throat/ loss of breath; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 34-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Dec2022 at 10:00 as dose 3 (booster), single (Lot number: GK1337) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing); "obesity" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "COVID" (unspecified if ongoing), notes: If COVID prior vaccination Yes; "Depression" (unspecified if ongoing), notes: Other medications in 2 weeks: :depression and anxiety medicine; "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN; OMEPRAZOLE. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EW0151, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 08Apr2021, when the patient was 32-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: ER8727, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 18Mar2021, when the patient was 32-year-old, for COVID-19 immunization. The following information was reported: BRAIN INJURY (death, hospitalization, life threatening) with onset 21Dec2022 at 04:30, outcome "fatal", described as "anoxic brain damage"; CARDIOMYOPATHY (death, hospitalization, life threatening) with onset 21Dec2022 at 04:30, outcome "fatal"; DYSPNOEA (death, hospitalization, life threatening) with onset 21Dec2022 at 04:30, outcome "fatal", described as " had trouble breathing stating she felt she had something in her throat/ loss of breath ". The patient was hospitalized for cardiomyopathy, brain injury, dyspnoea, (hospitalization duration: 2 day(s)). The events "cardiomyopathy", "anoxic brain damage" and "had trouble breathing stating she felt she had something in her throat/ loss of breath " required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Dec2022) Negative. Therapeutic measures were taken as a result of cardiomyopathy, brain injury, dyspnoea. The patient date of death was 22Dec2022. Reported cause of death: "Ischaemic cardiomyopathy". No autopsy was performed.  Additional information: 12 days after dose, had trouble breathing Stating she felt she had something in her throat. This led to loss of breath, cardiomyopathy, and anoxic brain damage which resulted in her death. Treatment includes: Ventilator and medications and will need to contact hospital.; Reported Cause(s) of Death: Ischaemic cardiomyopathy
Age: 34.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19, COVID19-2
Symptoms: Brain injury, Death, Echocardiogram, Ischaemic cardiomyopathy, Mechanical ventilation
Clinical narrative: cardiomyopathy; anoxic brain damage; had trouble breathing stating she felt she had something in her throat/ loss of breath; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 34-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Dec2022 at 10:00 as dose 3 (booster), single (Lot number: GK1337) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing); "obesity" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "COVID" (unspecified if ongoing), notes: If COVID prior vaccination Yes; "Depression" (unspecified if ongoing), notes: Other medications in 2 weeks: :depression and anxiety medicine; "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN; OMEPRAZOLE. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EW0151, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 08Apr2021, when the patient was 32-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: ER8727, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 18Mar2021, when the patient was 32-year-old, for COVID-19 immunization. The following information was reported: BRAIN INJURY (death, hospitalization, life threatening) with onset 21Dec2022 at 04:30, outcome "fatal", described as "anoxic brain damage"; CARDIOMYOPATHY (death, hospitalization, life threatening) with onset 21Dec2022 at 04:30, outcome "fatal"; DYSPNOEA (death, hospitalization, life threatening) with onset 21Dec2022 at 04:30, outcome "fatal", described as " had trouble breathing stating she felt she had something in her throat/ loss of breath ". The patient was hospitalized for cardiomyopathy, brain injury, dyspnoea, (hospitalization duration: 2 day(s)). The events "cardiomyopathy", "anoxic brain damage" and "had trouble breathing stating she felt she had something in her throat/ loss of breath " required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Dec2022) Negative. Therapeutic measures were taken as a result of cardiomyopathy, brain injury, dyspnoea. The patient date of death was 22Dec2022. Reported cause of death: "Ischaemic cardiomyopathy". No autopsy was performed.  Additional information: 12 days after dose, had trouble breathing Stating she felt she had something in her throat. This led to loss of breath, cardiomyopathy, and anoxic brain damage which resulted in her death. Treatment includes: Ventilator and medications and will need to contact hospital.; Reported Cause(s) of Death: Ischaemic cardiomyopathy