chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Chest discomfort, Cough, Fatigue, Pruritus
Clinical narrative: Itching inside chest, tightening, and tickle turned into a cough, fatigue. Dr. advised to take Ibuprofen over phone.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Bowel movement irregularity, Chills, Defaecation urgency, Exercise tolerance decreased
Clinical narrative: 12/15/2020 615 received vaccine 2pm belly pains, relief 'not like normal bowel movement', 'urge to go'  5 belly pain, relief self'not like normal bowel movement', 'urge to go'   8-10 pm body chills, covered with 3+ blankets 10 pm body chills subsided 12/16/2020 fatigue; not exercise; 5miles per day (only able to walk 2 miles)  Flu vaccine;  'pretty sure it was 09/2020'; Unknown brand
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: 12/15/2020 615 received vaccine 2pm belly pains, relief 'not like normal bowel movement', 'urge to go'  5 belly pain, relief self'not like normal bowel movement', 'urge to go'   8-10 pm body chills, covered with 3+ blankets 10 pm body chills subsided 12/16/2020 fatigue; not exercise; 5miles per day (only able to walk 2 miles)  Flu vaccine;  'pretty sure it was 09/2020'; Unknown brand
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure increased, Chest discomfort, Paraesthesia, Pharyngeal paraesthesia
Clinical narrative: Patient received the vaccine. During the 15 minute observation period she developed chest heaviness, arm tingling, and throat tingling. BP elevated at 169/79. The patient was sent to the ED and evaluated. Diagnosed with more anxiety type symptoms. Discharge from ED stable.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Chest discomfort, Chest pain, Dizziness, Feeling hot
Clinical narrative: 17 minutes after vaccine, suddenly had a , crushing squeezing chest pain, very severe lasted 45 seconds. after 45 seconds continue to have moderate chest pain, light headiness, diaphoretic, very hot. NO fever, elevated BP. Mild to moderate chest and light headiness for about 3-4 hours and it self solved.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: 17 minutes after vaccine, suddenly had a , crushing squeezing chest pain, very severe lasted 45 seconds. after 45 seconds continue to have moderate chest pain, light headiness, diaphoretic, very hot. NO fever, elevated BP. Mild to moderate chest and light headiness for about 3-4 hours and it self solved.
Age: 64.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site urticaria
Clinical narrative: Patient reported on 12/17/20 that she has been experiencing itching at vaccination site since her injection on 10/19/20. The area is red and sometimes develops hives/rash when it itches.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Magnetic resonance imaging, Toothache, Trigeminal neuralgia
Clinical narrative: Dec 2 developed tooth pain on one tooth, Dec. 3 all lower teeth aching, Dec. 4 excruciating spikes of pain which where triggered with eating, talking, hot cold and random
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Contraindicated product administered
Clinical narrative: She had received a shingles vaccine on 12/10/2020.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: I had a headache, body aches and fatigue.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Chills, Cold sweat, Confusional state, Dizziness
Clinical narrative: Patient complained of vision disturbance confusion dizziness, chills, clammy,  no trouble breathing. Nausea, Patient stated she did not have any breakfast. gave patient diphenhydramine 25 mg and EMS arrived to take her to the hospital.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Visual impairment
Clinical narrative: Patient complained of vision disturbance confusion dizziness, chills, clammy,  no trouble breathing. Nausea, Patient stated she did not have any breakfast. gave patient diphenhydramine 25 mg and EMS arrived to take her to the hospital.
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Slow response to stimuli, Visual impairment
Clinical narrative: After receiving vaccine patient started complain of vision disturbance, confusion, nurses started he was slow to respond. Nurses also documented that he was acting the same way the day before due to UTI. No SOB . no signs of allergic reaction
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: started feeling nauseated, had her sit until feelings resolved.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Balance disorder, Blood test normal, Computerised tomogram head, Hypoaesthesia, Limb discomfort
Clinical narrative: Next morning/day  l arm pain, resolved after a day; heaviness in arms and legs, slow speech, unbalanced in standing, r arm weakness, r arm/hand numb unable to use. R arm/hand still weak and cannot manipulate with right hand for self-care.  ER visit -- advise to  f/u with PCP. Appointment 12/21/20
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Muscular weakness, Pain in extremity, Paralysis, Slow speech
Clinical narrative: Next morning/day  l arm pain, resolved after a day; heaviness in arms and legs, slow speech, unbalanced in standing, r arm weakness, r arm/hand numb unable to use. R arm/hand still weak and cannot manipulate with right hand for self-care.  ER visit -- advise to  f/u with PCP. Appointment 12/21/20
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Abdominal pain upper, Chills, Erythema, Feeling abnormal, Headache
Clinical narrative: 11 yo female child presented to clinic with mother. Child received Tdap, meningococcal, and HPV9 vaccine. MOP reported child was starting to feel bad later on that day. (+) nausea, headache, chills, feverish, stomach pain. MOP reported local reaction  on her left arm (+) erythema, inflammation progressing to size of hand, hot to touch. MOP treated with anti inflammatory last night with no relief.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Inflammation, Local reaction, Nausea, Pyrexia, Skin warm
Clinical narrative: 11 yo female child presented to clinic with mother. Child received Tdap, meningococcal, and HPV9 vaccine. MOP reported child was starting to feel bad later on that day. (+) nausea, headache, chills, feverish, stomach pain. MOP reported local reaction  on her left arm (+) erythema, inflammation progressing to size of hand, hot to touch. MOP treated with anti inflammatory last night with no relief.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram normal, Confusional state, Dyspnoea, Haematuria, Laboratory test normal
Clinical narrative: Patient reported to CNA that they felt like they soiled their pants.  CNA confirmed that patient did not soil themself and transferred patient to the restroom. While the patient was on the toilet attempting to have a bowel movement the CNA reported patient had 10 seconds of tonic clonic behavior and then went unresponsive and then back to tonic clonic behavior.  This happened 3 times prior to getting patient put back into his bed.  Patient went unconscious after last episode while on bed for a more extended period of time while a STAT page was called.  Physical Therapist and Aid sternal rubbed him and he had gasp and woke up.  Prior to and immediately following the episode his vitals were within normal limits.  Neuro exam was unremarkable after patient came to.  When he woke up he knew his name, date, and day of the week.  He was only confused to where he was.  Patient was agreeable to be transported out.  EMS was called and transported the patient to Hospital.  Patient displayed no seizure activity or neurological deficits in ER.   Patient had a CT scan, which came back normal.  Virals remained within normal limits and laboratory values were noncontributory.  He was diagnosed with a UTI due to the presence of hematuria associated with a syncopal episode.  Patient had a Foley catheter upon admission to the nursing home.  Patient was administered Ceftriaxone at the hospital and discharged back to Nursing Home on Omnicef the same day.  Patient is back at nursing home facility and has not displayed any additional signs of seizure.  He is stable and Foley catheter has been removed.  Facility spoke to wife who reported that patient did not have a seizure history.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Neurological examination normal, Syncope, Tonic clonic movements, Unresponsive to stimuli
Clinical narrative: Patient reported to CNA that they felt like they soiled their pants.  CNA confirmed that patient did not soil themself and transferred patient to the restroom. While the patient was on the toilet attempting to have a bowel movement the CNA reported patient had 10 seconds of tonic clonic behavior and then went unresponsive and then back to tonic clonic behavior.  This happened 3 times prior to getting patient put back into his bed.  Patient went unconscious after last episode while on bed for a more extended period of time while a STAT page was called.  Physical Therapist and Aid sternal rubbed him and he had gasp and woke up.  Prior to and immediately following the episode his vitals were within normal limits.  Neuro exam was unremarkable after patient came to.  When he woke up he knew his name, date, and day of the week.  He was only confused to where he was.  Patient was agreeable to be transported out.  EMS was called and transported the patient to Hospital.  Patient displayed no seizure activity or neurological deficits in ER.   Patient had a CT scan, which came back normal.  Virals remained within normal limits and laboratory values were noncontributory.  He was diagnosed with a UTI due to the presence of hematuria associated with a syncopal episode.  Patient had a Foley catheter upon admission to the nursing home.  Patient was administered Ceftriaxone at the hospital and discharged back to Nursing Home on Omnicef the same day.  Patient is back at nursing home facility and has not displayed any additional signs of seizure.  He is stable and Foley catheter has been removed.  Facility spoke to wife who reported that patient did not have a seizure history.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Urinary assistance device user, Urinary tract infection
Clinical narrative: Patient reported to CNA that they felt like they soiled their pants.  CNA confirmed that patient did not soil themself and transferred patient to the restroom. While the patient was on the toilet attempting to have a bowel movement the CNA reported patient had 10 seconds of tonic clonic behavior and then went unresponsive and then back to tonic clonic behavior.  This happened 3 times prior to getting patient put back into his bed.  Patient went unconscious after last episode while on bed for a more extended period of time while a STAT page was called.  Physical Therapist and Aid sternal rubbed him and he had gasp and woke up.  Prior to and immediately following the episode his vitals were within normal limits.  Neuro exam was unremarkable after patient came to.  When he woke up he knew his name, date, and day of the week.  He was only confused to where he was.  Patient was agreeable to be transported out.  EMS was called and transported the patient to Hospital.  Patient displayed no seizure activity or neurological deficits in ER.   Patient had a CT scan, which came back normal.  Virals remained within normal limits and laboratory values were noncontributory.  He was diagnosed with a UTI due to the presence of hematuria associated with a syncopal episode.  Patient had a Foley catheter upon admission to the nursing home.  Patient was administered Ceftriaxone at the hospital and discharged back to Nursing Home on Omnicef the same day.  Patient is back at nursing home facility and has not displayed any additional signs of seizure.  He is stable and Foley catheter has been removed.  Facility spoke to wife who reported that patient did not have a seizure history.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Injection site reaction, Migraine, Muscle fatigue
Clinical narrative: Fatigue, migraine, muscle fatigue on site, diarrhea.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Chest X-ray, Dyspnoea, Flushing, Hypoaesthesia
Clinical narrative: Approximately 11 minutes after receiving the vaccine, the patient complained of shortness of breath, tingling in arms and hands, numbness and tingling in legs and feet, and was observably shaking, with no complaints of swelling in throat or other signs of anaphylaxis. Patient was brought to ER in same facility via stretcher and was examined by staff there. ER report states the patient presented with shortness of breath and what appeared to be a panic attack, with fast breathing, slight flushing, and shaking. Per ER report, the patient was treated for an acute anaphylactic reaction, with clear lungs and given an EpiPen shot in the right thigh. IV was initiated and given a fluid bolus, solu medrol, famotidine, and lorazepam. Labs and a chest x-ray done and reviewed. After treatment, patient found to be stable and was discharged home at 4:42 pm with orders for famotidine, albuterol inhaler, and epinephrine pen.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Panic attack, Paraesthesia, Respiratory rate increased, Tremor
Clinical narrative: Approximately 11 minutes after receiving the vaccine, the patient complained of shortness of breath, tingling in arms and hands, numbness and tingling in legs and feet, and was observably shaking, with no complaints of swelling in throat or other signs of anaphylaxis. Patient was brought to ER in same facility via stretcher and was examined by staff there. ER report states the patient presented with shortness of breath and what appeared to be a panic attack, with fast breathing, slight flushing, and shaking. Per ER report, the patient was treated for an acute anaphylactic reaction, with clear lungs and given an EpiPen shot in the right thigh. IV was initiated and given a fluid bolus, solu medrol, famotidine, and lorazepam. Labs and a chest x-ray done and reviewed. After treatment, patient found to be stable and was discharged home at 4:42 pm with orders for famotidine, albuterol inhaler, and epinephrine pen.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Syringe issue
Clinical narrative: The nurse was tapping the syringe to get all the air out and the needle popped out of the vaccine vial and stuck to the sticker that was on the vial. 0.3ml of the vaccine was discarded with the syringe into the sharps box.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling of body temperature change, Headache, Myalgia
Clinical narrative: I woke up at 6:15am had a terrible headache, low fever 100.1. I took Tylenol for the headache and fever. Throughout the day exp muscle aches and joint pain. I also exp hot/cold flashes and fatigue. Around 6:00pm on 12/16 started to l feel better and was able to return to work on 12/17.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I woke up at 6:15am had a terrible headache, low fever 100.1. I took Tylenol for the headache and fever. Throughout the day exp muscle aches and joint pain. I also exp hot/cold flashes and fatigue. Around 6:00pm on 12/16 started to l feel better and was able to return to work on 12/17.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Pyrexia
Clinical narrative: I took tylenol for fever and headache and rested, left side lymph nodes were swollen on 12/16/20 which was the worst day, and has gotten better today 12/17/2020. Did not go to the doctor.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Diplopia, Dysarthria, Nausea, Pain in extremity
Clinical narrative: Slurred speech, double vision, loss of balance, pain in both legs, nausea, fever,
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Slurred speech, double vision, loss of balance, pain in both legs, nausea, fever,
Age: 50.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Arthralgia, Asthenia, Computerised tomogram, Facial paralysis, Headache
Clinical narrative: Day of vaccine 3 -4 hours after receiving the vaccine, I began feeling tingling in my right arm, progressed to numbness and extreme pain in the shoulder. I have been having weakness and it hurts to use it. Headaches on the right side of head, around ear.  Facial drooping began , I was then taken to the hospital and was placed on stroke watch. I was then cleared of a stroke and sent home. I followed up with Dr.,  who has diagnosed me with having bells palsy. It has been over a week and I am still having trouble with my speech which is pretty noticeable.  I am having short term memory.
Age: 50.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Hypoaesthesia, Laboratory test, Magnetic resonance imaging, Memory impairment, Pain
Clinical narrative: Day of vaccine 3 -4 hours after receiving the vaccine, I began feeling tingling in my right arm, progressed to numbness and extreme pain in the shoulder. I have been having weakness and it hurts to use it. Headaches on the right side of head, around ear.  Facial drooping began , I was then taken to the hospital and was placed on stroke watch. I was then cleared of a stroke and sent home. I followed up with Dr.,  who has diagnosed me with having bells palsy. It has been over a week and I am still having trouble with my speech which is pretty noticeable.  I am having short term memory.
Age: 50.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Paraesthesia, Speech disorder
Clinical narrative: Day of vaccine 3 -4 hours after receiving the vaccine, I began feeling tingling in my right arm, progressed to numbness and extreme pain in the shoulder. I have been having weakness and it hurts to use it. Headaches on the right side of head, around ear.  Facial drooping began , I was then taken to the hospital and was placed on stroke watch. I was then cleared of a stroke and sent home. I followed up with Dr.,  who has diagnosed me with having bells palsy. It has been over a week and I am still having trouble with my speech which is pretty noticeable.  I am having short term memory.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: Caller stated at 11:30 a.m  caller had right arm pain at injection site and headache.  12/17/20 headache and arm paid has subsided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever (37.8 °C) and muscle pain.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Headache, Rosacea
Clinical narrative: Headache, right retroocular pain, exacerbation of rosacea  Tx. acetaminophen  Duration: 3 hours
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Migraine, Myalgia, Pyrexia
Clinical narrative: Migraine headache,  Fever of 101.7, chills, extreme stomach cramping, extreme muscle aches in the upper shoulder and neck region. Symptoms lasted for 32 hours.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Headaches, fever, swelling, redness, muscle aches, nauseated for 2 weeks after second shingrix vaccination
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Headaches, fever, swelling, redness, muscle aches, nauseated for 2 weeks after second shingrix vaccination
Age: 0.17
Sex: F
Vaccine: UNK
Symptoms: Abdominal discomfort, Abdominal distension, Dyschezia, Eating disorder, Flatulence
Clinical narrative: After oral rotavirus vaccine, 2 month old baby has older GI discomfort, gas, bloating, trouble pooping. Disruption of ability to eat. Symptoms lasting over 2 weeks after administering vaccine. Probiotic drops seem to improve the situation.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Nausea, Pruritus
Clinical narrative: 12/15/2020 Around 7:30pm, I started to itch on neck and face. Progressed to scalp, stomach, back and whole body; ears, top of head to bottom of toes. Called critical care healthcare staff; 1 25mg  benadryl  Had nausea, fatigue, hip and joint pain 12/16/2020 Still itchy not as severe as 12/15/2020. Still joint pain and achiness. Nausea was a 8/10.  12/17/2020 feel better. About 80% . Mild itchiness. 'letting it run its course' and haven't taken any other benadryl since 12/15/2020. Joint and nausea has subsided.  Flu shot 09/2020 Second dose of Pfizer shot is scheduled for 01/05/2021
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal distension, Abdominal pain, Chills, Diarrhoea, Dizziness
Clinical narrative: diarrhea >7 weeks, long, thin, chunks; 4-6 times a day, moderate quantity, no fever, weight change, lightheadedness, chills, nausea, vomiting, bloating; mild intermittent suprapubic abdominal pain lasting 5-10 minutes
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Vomiting, Weight
Clinical narrative: diarrhea >7 weeks, long, thin, chunks; 4-6 times a day, moderate quantity, no fever, weight change, lightheadedness, chills, nausea, vomiting, bloating; mild intermittent suprapubic abdominal pain lasting 5-10 minutes
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dizziness, Dysgeusia, Dysphagia, Dyspnoea
Clinical narrative: ~30 minutes after vaccination, patient reported lightheadedness, difficulty swallowing, SOB, feeling flushed, pallor, bilateral arm tingling, brief chest pain and tremors. Symptoms lasted approximately 30 minutes and then resolved. Benadryl given after resolution of acute symptoms. Reported a metallic taste in her mouth immediately after receiving the COVID vaccine (dose #1). Had uneventful 15 minute recovery period immediately after vaccination.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram normal, Flushing, Immediate post-injection reaction, Pallor, Paraesthesia
Clinical narrative: ~30 minutes after vaccination, patient reported lightheadedness, difficulty swallowing, SOB, feeling flushed, pallor, bilateral arm tingling, brief chest pain and tremors. Symptoms lasted approximately 30 minutes and then resolved. Benadryl given after resolution of acute symptoms. Reported a metallic taste in her mouth immediately after receiving the COVID vaccine (dose #1). Had uneventful 15 minute recovery period immediately after vaccination.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: ~30 minutes after vaccination, patient reported lightheadedness, difficulty swallowing, SOB, feeling flushed, pallor, bilateral arm tingling, brief chest pain and tremors. Symptoms lasted approximately 30 minutes and then resolved. Benadryl given after resolution of acute symptoms. Reported a metallic taste in her mouth immediately after receiving the COVID vaccine (dose #1). Had uneventful 15 minute recovery period immediately after vaccination.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood gases, Chest X-ray, Dysgeusia, Dysphagia, Dyspnoea
Clinical narrative: ~30 minutes after vaccination, patient reported lightheadedness, difficulty swallowing, SOB, feeling flushed, pallor, bilateral arm tingling, brief chest pain and tremors. Symptoms lasted approximately 30 minutes and then resolved. Benadryl given after resolution of acute symptoms. Reported a metallic taste in her mouth immediately after receiving the COVID vaccine (dose #1). Had uneventful 15 minute recovery period immediately after vaccination.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Hypoaesthesia, Metabolic acidosis, Paraesthesia, Tachycardia
Clinical narrative: ~30 minutes after vaccination, patient reported lightheadedness, difficulty swallowing, SOB, feeling flushed, pallor, bilateral arm tingling, brief chest pain and tremors. Symptoms lasted approximately 30 minutes and then resolved. Benadryl given after resolution of acute symptoms. Reported a metallic taste in her mouth immediately after receiving the COVID vaccine (dose #1). Had uneventful 15 minute recovery period immediately after vaccination.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Troponin
Clinical narrative: ~30 minutes after vaccination, patient reported lightheadedness, difficulty swallowing, SOB, feeling flushed, pallor, bilateral arm tingling, brief chest pain and tremors. Symptoms lasted approximately 30 minutes and then resolved. Benadryl given after resolution of acute symptoms. Reported a metallic taste in her mouth immediately after receiving the COVID vaccine (dose #1). Had uneventful 15 minute recovery period immediately after vaccination.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dizziness, Dysgeusia, Dysphagia, Dyspnoea
Clinical narrative: Shortly Administration of vaccine I experienced a metallic taste.  approximately 40 minutes after administration of vaccine I experienced difficulty swallowing, dyspnea,  tachycardia and numbness in tingling in bilateral hands. I am a healthcare provider and I received the vaccine at my place of employment. I was taken to the emergency department for monitoring.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram normal, Flushing, Immediate post-injection reaction, Pallor, Paraesthesia
Clinical narrative: Shortly Administration of vaccine I experienced a metallic taste.  approximately 40 minutes after administration of vaccine I experienced difficulty swallowing, dyspnea,  tachycardia and numbness in tingling in bilateral hands. I am a healthcare provider and I received the vaccine at my place of employment. I was taken to the emergency department for monitoring.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Shortly Administration of vaccine I experienced a metallic taste.  approximately 40 minutes after administration of vaccine I experienced difficulty swallowing, dyspnea,  tachycardia and numbness in tingling in bilateral hands. I am a healthcare provider and I received the vaccine at my place of employment. I was taken to the emergency department for monitoring.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood gases, Chest X-ray, Dysgeusia, Dysphagia, Dyspnoea
Clinical narrative: Shortly Administration of vaccine I experienced a metallic taste.  approximately 40 minutes after administration of vaccine I experienced difficulty swallowing, dyspnea,  tachycardia and numbness in tingling in bilateral hands. I am a healthcare provider and I received the vaccine at my place of employment. I was taken to the emergency department for monitoring.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Hypoaesthesia, Metabolic acidosis, Paraesthesia, Tachycardia
Clinical narrative: Shortly Administration of vaccine I experienced a metallic taste.  approximately 40 minutes after administration of vaccine I experienced difficulty swallowing, dyspnea,  tachycardia and numbness in tingling in bilateral hands. I am a healthcare provider and I received the vaccine at my place of employment. I was taken to the emergency department for monitoring.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Troponin
Clinical narrative: Shortly Administration of vaccine I experienced a metallic taste.  approximately 40 minutes after administration of vaccine I experienced difficulty swallowing, dyspnea,  tachycardia and numbness in tingling in bilateral hands. I am a healthcare provider and I received the vaccine at my place of employment. I was taken to the emergency department for monitoring.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injected limb mobility decreased, Myalgia, Pain in extremity
Clinical narrative: 2 hours later pain in arm approximately 4-5 inches. Was not able to utilize left arm on yesterday. last night experienced muscle aches and chills. Taken Tylenol and rested.  This morning experienced a really bad headache.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Physical examination, Tissue injury
Clinical narrative: Tissue damage causing a lump and redness in the administered area  and pain.  Took around 2 months to heal.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Individual received vaccine on 12/17/20 at 0815.  Began with feeling faint and "spinning" at approx. 11:00 am, reported resolution of symptoms at approx. 11:11 am on 12/17/20.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Pruritus, Rash, Rash erythematous
Clinical narrative: Stayed for 15 minutes after the vaccine given and no reaction was noted and she left.  States she got into her car about 20 minutes after the vaccine and started to "itch" all over and noted "red bumps" on the back of her neck.  She had a flushed face by the time she arrived home but remained afebrile.  Her itchiness is better but only concentrated on the back of her neck on 12/17/20 when she reported the reaction to Employee Health Services.  She denied any further issues today.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Nausea, Pain in extremity
Clinical narrative: I have a sore arm and I am experiencing severe back pain, nausea and a headache that comes and goes.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain upper, Constipation, Hypophagia, Laboratory test, Magnetic resonance imaging
Clinical narrative: After received the vaccine that evening i started getting nauseous. I took some Pepto and I went to bed. I walked upstairs I vomited in bathroom. 6 Hours straight I vomited and had dry heaves. The next day I did not eat much and I drank some. My stomach and digestive system was hurting bad. I thought it might be appendicitis and I called my Doctor. My doctor told me to go to the ER. I went to the ER and they ran tests. They stated they I was extremely constipated so they gave me medication. I went home and I was in so much pain I went back to the ER. They kept me over night for observation. I went home the next day and told me to take my meds a little at a time.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pain, Retching, Vomiting
Clinical narrative: After received the vaccine that evening i started getting nauseous. I took some Pepto and I went to bed. I walked upstairs I vomited in bathroom. 6 Hours straight I vomited and had dry heaves. The next day I did not eat much and I drank some. My stomach and digestive system was hurting bad. I thought it might be appendicitis and I called my Doctor. My doctor told me to go to the ER. I went to the ER and they ran tests. They stated they I was extremely constipated so they gave me medication. I went home and I was in so much pain I went back to the ER. They kept me over night for observation. I went home the next day and told me to take my meds a little at a time.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: redness, swelling, traveled down the arm
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Brain injury, Cardiac arrest, Hypoxic-ischaemic encephalopathy, Pneumonia aspiration, Respiratory failure
Clinical narrative: Cardiac Arrest/Respiratory Failure Severe global HIE brain injury Aspiration Pneumonia R/O Vaccine Encephalopathy per Pediatric Neurologist
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site erythema, Injection site pain, Limb discomfort, Mobility decreased
Clinical narrative: arm felt hot to the touch, felt arm heavy very difficult to move the arm, felt feverish, took temperature but no fever, but hot to the touch, lots of chills, nausea, body aches.  Took some tylenol and at night it started getting a little better.  This morning the injection site is red and is sore but I can move my arm again.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Skin warm
Clinical narrative: arm felt hot to the touch, felt arm heavy very difficult to move the arm, felt feverish, took temperature but no fever, but hot to the touch, lots of chills, nausea, body aches.  Took some tylenol and at night it started getting a little better.  This morning the injection site is red and is sore but I can move my arm again.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Skin warm, Swelling, Tenderness
Clinical narrative: right deltoid swollen, warm and tender
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Nausea, Pain, Pyrexia
Clinical narrative: Immediate internal burning pain in right shoulder and right arm and right forearm and right hand lasting 72 hours. Right arm hot to touch for 72 hours after injection. Unable to raise right arm for 72 hours due to intense right arm pain. 100.2 fever starting 4 hours after injection, lasting about 24 hours. Nausea starting 4 hours after injection, lasting 6 hours. Prickly red rash on right inner thigh started 16 hours after injection, lasting 72 hours.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin warm
Clinical narrative: Immediate internal burning pain in right shoulder and right arm and right forearm and right hand lasting 72 hours. Right arm hot to touch for 72 hours after injection. Unable to raise right arm for 72 hours due to intense right arm pain. 100.2 fever starting 4 hours after injection, lasting about 24 hours. Nausea starting 4 hours after injection, lasting 6 hours. Prickly red rash on right inner thigh started 16 hours after injection, lasting 72 hours.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache
Clinical narrative: chills, headache, weakness, fatigue
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: stated her lips started to feel numb, like she was at the dentist. lips did not appear cyanotic.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Neck pain, Pain, Pain in extremity
Clinical narrative: about 1 1/2 hour after receiving it I felt a pain and numbness down left arm into pinky and ring finger. That only last about 2 minutes. Then the pain radiated to left side of neck and head and headache is still there at 1pm.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Caller had vaccine and at 12:30 at night caller had extreme paid in left arm and had to take Tylenol. Next day caller stated pain had subsided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Dizziness, Headache, Syncope
Clinical narrative: Employee states that there was confusion at the time of vaccine injection, and that she was possibly given a second injection right after the first. approximately 45 minutes later she experienced headache and dizziness and had an observed syncopal episode. She was taken to the ER, evaluated for MI. Was found to be stable and was discharged.
Age: 42.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Pain, Pain in extremity, X-ray
Clinical narrative: Persistent and ongoing left arm pain since receiving the flu vaccination in mid-October 2020.   Left arm feels sore and aches all the time.  Hurts to lift left arm, difficult to get dressed, put on coat, and is especially sore at night.  Feel the pain has progressed to shoulder area as well.  Called Employee Health at my workplace (where vaccine was given), they advised calling PCP which as done.  Went to PCP for office visit 11/30/20, he recommended getting an xray of left arm/shoulder which was completed 12/1/20.  PCP also ordered ultrasound which is scheduled for 12/21/20.
Age: 22.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: On her right arm at the MMR site, it is red and raised.  She also describes  a rash on her abdomen, foot and legs that is itchy. No fever
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: no adverse event; 2 vials of MMRII were left out of the freezer for 9 hours/ one vial was inadvertently administered to a patient; This spontaneous report was received from a registered nurse and refers to a 12 month old male patient. No information regarding the patient's medical history was provided. His concurrent conditions included nasopharyngitis. The patient had no allergies. On 19-NOV-2020, at the age of 12 months, the patient was vaccinated inadvertently with incorrectly stored first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHa)) (M-M-R II) vial, 0.5 ml, lot # S035352 with expiration date on 05-NOV-2021, subcutaneously in the left thigh for prophylaxis by medical assistant. Administered vaccine was left out of the freezer and underwent a temperature excursion of 70 degrees Fahrenheit for 9 hours. No adverse event reported. Digital data logger was not involved and there was no previous temperature excursions reported.
Age: 32.0
Sex: F
Vaccine: HPV9, HPV9, TDAP
Symptoms: Exposure during pregnancy, Wrong product administered
Clinical narrative: a pregnant patient was inadvertently administered GARDASIL 9 prefilled syringe yesterday, instead of TDAP vaccine; a pregnant patient was inadvertently administered GARDASIL 9 prefilled syringe yesterday, instead of TDAP vaccine; This spontaneous prospective pregnancy report was received from a registered nurse referring to a 32 years old female patient. No information regarding pertinent medical history, concomitant medication, drug reaction or allergies was provided.    On 01-DEC-2020, the patient was inadvertently administered a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1687292, expiration date 25-AUG-2022; dose number and route were unknown) for prophylaxis instead of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (TDAP) (exposure during pregnancy, wrong product administered). The patient was 30-week pregnant. Last menstrual period was on 05-MAY-2020. Pregnancy outcome was pending. The outcome of the events was unknown. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: M
Vaccine: MMR
Symptoms: Seizure
Clinical narrative: He is autistic; My youngest had a seizure after his first MMR; This spontaneous report was received from the patient's mother referring to a male patient of unknown age. The patient's concurrent conditions, concomitant medications, and medical history were not provided.  On an unknown date, the patient was vaccinated with first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, route of administration, lot# and expiration date were not provided) for prophylaxis.       On an unknown date, the patient had a seizure after his first measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). He was autistic.  The outcome of the events was unknown. The causality between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.  Upon internal review, seizure and autism were determined to be medically significant.
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Rash, Vomiting
Clinical narrative: severe diarrhea; vomiting; Generalised rash; Accidental exposure; Exposure via skin contact; This literature marketed report has been received from the authors of a published literature article, titled as stated below concerning to 30- year-old female patient. The patient's concurrent conditions included breast-feeding and Crohn's disease. No information was provided regarding the patient's medical history, previous drug reactions, allergies and concomitant medications.  On an unknown date, the patient's three-month-old infant was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (also reported as "RV5") for prophylaxis (strength, dose, lot number and expiration date were not reported).   On an unknown date, within a few hours after her three-month-old infant received the vaccine (also reported as "potential indirect exposure"), the patient developed a generalized rash. She also developed severe diarrhea and vomiting and was hospitalized due to these events. The outcome was not reported.   Potentially, due to the indirect exposure, the authors considered the patient's events to be related to rotavirus vaccine, live, oral, pentavalent (ROTATEQ).  A copy of the published article is attached as further documentation of the patient's experience.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Pain, Rash
Clinical narrative: painful blistering; rash; Information has been received from a lawyer regarding a case in litigation referring to an elderly patient (pt) of unknown age or gender. The pt's concurrent conditions, medical history and concomitant medications were not reported. On 06-OCT-2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, anatomical location, lot number and expiration date were not provided) administered at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unspecified date, the pt was treated by a health care provider (HCP) for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX)use: painful blistering and rashes. The outcome of the claimed events was not provided, and causal relationship was reported as related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Bell's palsy; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 17-JUN-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for the long-term prevention of shingles and zoster-related conditions by a pharmacist. At the time of vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through patient's healthcare provider(s) that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced patient to be vaccinated. Subsequently (date not reported), the patient was treated by a physician for Bell's palsy. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was unknown. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the event Bell's palsy was determined to be medically significant event.
Age: 73.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: post herpetic neuralgia; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a currently 77-year-old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about April 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On an unknown date, reported as subsequent to the vaccination, the patient was treated for shingles and post herpetic neuralgia. The outcome of shingles and post herpetic neuralgia was not reported. The reporter considered shingles and post herpetic neuralgia to be related to zoster vaccine live (ZOSTAVAX).
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: the patient passed out and felt dizzy upon waking soon after receiving his first dose of GARDASIL; the patient passed out and felt dizzy upon waking soon after receiving his first dose of GARDASIL; This spontaneous report was received from a consumer via company representative and refers to a 13-year-old male patient. He was the company representative's nephew. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 07-DEC-2020, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On the same day, soon after receiving the vaccination, he passed out and felt dizzy after waking up. The events occurred in the doctor's office, but a nurse or doctor were not present and the events were not reported to any health care professional. The consumer was instructed to call the physician to report the events and ask whether a second dose of the vaccine should be administered. No treatment was given for the adverse events. The outcome of the events was reported as unknown.   The causal relationship between the events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was unknown.  Upon internal review, the event of loss of consciousness was considered to be medically significant.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Visual impairment
Clinical narrative: postherpetic neuralgia; vision issues; multiple outbreaks of herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a currently 65-year old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 21-SEP-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On an unknown date, reported as subsequent to the vaccination, the patient was treated for multiple outbreaks of herpes zoster, postherpetic neuralgia and vision issues. The outcome of herpes zoster, postherpetic neuralgia and visual impairment was not reported. The reporter considered herpes zoster, postherpetic neuralgia and visual impairment to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 20-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves patient (unknown demographics) who experienced flu (influenza), while he/she received vaccine INFLUENZA VACCINE.  Past vaccination(s) included INFLUENZA VACCIN with every year.  Medical history, medical treatment, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information available on the batch number for this case.