chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: Felt fine until 12 hours after 2nd dose - extreme nausea and vomiting, high fever, alternating chills and sweats for ~6 hours. 40 hours after dose, woke up and had several painful bumps on vulva and labia- small and white, slight redness around them. No history of STDs, more than a year since last sexual activity. Did some googling to figure out what it was and closely matched what was described/photos  in this paper .Searched "aphthous ulcers vulva" to confirm using more photos, and determine treatment/if I needed a doctor,  and came across a web site, which then led me to believe they bumps were related to the vaccine. Treated with over the counter hydrocortisone 1% every 12 hours for a total of 4 applications, and bumps are mostly painless and reduced in size.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting, Vulvovaginal rash
Clinical narrative: Felt fine until 12 hours after 2nd dose - extreme nausea and vomiting, high fever, alternating chills and sweats for ~6 hours. 40 hours after dose, woke up and had several painful bumps on vulva and labia- small and white, slight redness around them. No history of STDs, more than a year since last sexual activity. Did some googling to figure out what it was and closely matched what was described/photos  in this paper .Searched "aphthous ulcers vulva" to confirm using more photos, and determine treatment/if I needed a doctor,  and came across a web site, which then led me to believe they bumps were related to the vaccine. Treated with over the counter hydrocortisone 1% every 12 hours for a total of 4 applications, and bumps are mostly painless and reduced in size.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Death, Dyspnoea, Dyspnoea exertional, Fatigue
Clinical narrative: Within a few days, my mother started reporting profound fatigue and shortness of breath while conducting routine household activities. She no longer had to energy for her daily exercise walks and became increasingly lethargic. She died in her sleep while taking an afternoon nap on Thursday, February 4th. I am highly concerned this could be a vaccine related.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy
Clinical narrative: Within a few days, my mother started reporting profound fatigue and shortness of breath while conducting routine household activities. She no longer had to energy for her daily exercise walks and became increasingly lethargic. She died in her sleep while taking an afternoon nap on Thursday, February 4th. I am highly concerned this could be a vaccine related.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Painful rash on backside, that felt like a burn.  Rash on arm where vaccine was issued and on Back.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Cough, Feeling hot, Headache, Nervousness
Clinical narrative: 02/04/2021 Patient c/o feeling hot and throat itched.  h/o angioedema to unknown substance, carries epi pen.  h/o allergies to sulfa 1.0ml Diphenhydramine given IM in right deltoid (50mg per 1ml). administered at 1650.  BP 140/80, pulse 80 and regular.  Pt. reports that she feels like her airway is "opening up" after the Diphenhydramine.  A&O x3, c/o headache.    1715: Spoke to physician via phone.  Explained course of patient.  Physician asked that patient remain for an additional 10 minutes.  Patient agrees.  Responding appropriately.  Has slight cough, reports h/o well controlled Asthma.   1722 - BP 140/86  Pt. reports this reaction as somewhat normal for her.  Airway open and Breath Sounds normal.  Has dry cough, patient requested and received two 16 oz. bottles of water.  RR currently 18 (was 22).  Pt. reports being anxious and nervous.  1750 - BP 180/90 (patient reports BP always runs high), P - 72, RR 18 and regular.  Pt. reports slight h/a and feels stable and requests permission to leave.  Ambulated greater than 100 feet and was not SOB.    Patient managed by RN's
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: 02/04/2021 Patient c/o feeling hot and throat itched.  h/o angioedema to unknown substance, carries epi pen.  h/o allergies to sulfa 1.0ml Diphenhydramine given IM in right deltoid (50mg per 1ml). administered at 1650.  BP 140/80, pulse 80 and regular.  Pt. reports that she feels like her airway is "opening up" after the Diphenhydramine.  A&O x3, c/o headache.    1715: Spoke to physician via phone.  Explained course of patient.  Physician asked that patient remain for an additional 10 minutes.  Patient agrees.  Responding appropriately.  Has slight cough, reports h/o well controlled Asthma.   1722 - BP 140/86  Pt. reports this reaction as somewhat normal for her.  Airway open and Breath Sounds normal.  Has dry cough, patient requested and received two 16 oz. bottles of water.  RR currently 18 (was 22).  Pt. reports being anxious and nervous.  1750 - BP 180/90 (patient reports BP always runs high), P - 72, RR 18 and regular.  Pt. reports slight h/a and feels stable and requests permission to leave.  Ambulated greater than 100 feet and was not SOB.    Patient managed by RN's
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Thirst
Clinical narrative: Fatigue, excessive thirst, muscle soreness, headache within 1 hour of receiving vaccine. Symptoms subsided within 24 hours
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Impaired work ability, Pain, Poor quality sleep
Clinical narrative: received 2nd shot on 2-4-21.  Sleep during the night was restless.  Upon awakening, felt aches and discomfort.  Upon arrival at work on 2-5-21, symptoms continue and left work and went home to sleep and took measures usually done with cold or flu symptoms occurred in the past.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Anal incontinence, Asthenia, Computerised tomogram head normal, Grip strength decreased, Hypoaesthesia
Clinical narrative: Began to feel numbness, lack of sensation and loss of strength to the left limb from the waist down. Also noted weaker grip strength to the left hand. Loss of bladder and bowel control. This persisted throughout 2/5. On saturday 2/6 the right leg began to feel weak and numb as well although not as severe as the left limb. He was admitted to the hospital on Saturday evening, 2-6
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Magnetic resonance imaging brain normal, Magnetic resonance imaging spinal normal, Muscular weakness, Scan with contrast normal
Clinical narrative: Began to feel numbness, lack of sensation and loss of strength to the left limb from the waist down. Also noted weaker grip strength to the left hand. Loss of bladder and bowel control. This persisted throughout 2/5. On saturday 2/6 the right leg began to feel weak and numb as well although not as severe as the left limb. He was admitted to the hospital on Saturday evening, 2-6
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Sensory loss, Urinary incontinence
Clinical narrative: Began to feel numbness, lack of sensation and loss of strength to the left limb from the waist down. Also noted weaker grip strength to the left hand. Loss of bladder and bowel control. This persisted throughout 2/5. On saturday 2/6 the right leg began to feel weak and numb as well although not as severe as the left limb. He was admitted to the hospital on Saturday evening, 2-6
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Death, Dyspnoea, Fatigue, Malaise
Clinical narrative: Patient received his second dose of Moderna COVID vaccine on 2/6 at 12:40PM. Patient was observed for 15 minutes post-vaccination with no adverse events. On the evening of 2/6 (time unknown) the patient began to develop dry cough and fatigue. He was checked by a physician at that time (who was a family member). Patient continued to feel unwell into Sunday. His lungs were clear when checked Sunday afternoon (time unknown). At approximately 5:30pm on 2/7 the patient began experiencing sudden onset shortness of breath. A pulse ox was conducted at that time and it was 92%, and again shortly thereafter and it was 90% (as reported by family member). 9-1-1 was contacted at this time. CPR was initiated when he arrived at the emergency department, pulse ox was 60%  (as reported by family member). The patient passed away shortly thereafter on 2/8/2021.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Resuscitation
Clinical narrative: Patient received his second dose of Moderna COVID vaccine on 2/6 at 12:40PM. Patient was observed for 15 minutes post-vaccination with no adverse events. On the evening of 2/6 (time unknown) the patient began to develop dry cough and fatigue. He was checked by a physician at that time (who was a family member). Patient continued to feel unwell into Sunday. His lungs were clear when checked Sunday afternoon (time unknown). At approximately 5:30pm on 2/7 the patient began experiencing sudden onset shortness of breath. A pulse ox was conducted at that time and it was 92%, and again shortly thereafter and it was 90% (as reported by family member). 9-1-1 was contacted at this time. CPR was initiated when he arrived at the emergency department, pulse ox was 60%  (as reported by family member). The patient passed away shortly thereafter on 2/8/2021.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Pt reports having severe nausea for the first 24 hours, one week later her arm knotted up, had redness, heat, was itchy and painful to injection site that lasted for one week. Then started having constant pain in upper arm area since then (from shoulder to elbow area), pain becomes worse with use, throbbing pain and also shooting pain down entire arm at times. Did not call her doctor or seek medical attention. Arrived at appointment time on 2/1/21 for second dose but refuses second dose, reports she came only to report her symptoms.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: Pt reports having severe nausea for the first 24 hours, one week later her arm knotted up, had redness, heat, was itchy and painful to injection site that lasted for one week. Then started having constant pain in upper arm area since then (from shoulder to elbow area), pain becomes worse with use, throbbing pain and also shooting pain down entire arm at times. Did not call her doctor or seek medical attention. Arrived at appointment time on 2/1/21 for second dose but refuses second dose, reports she came only to report her symptoms.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on body
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Itching and swelling on hands and feet.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Headache, Thermal burn
Clinical narrative: Chest pain, burning in back and front of chest, headache
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Malaise
Clinical narrative: Intense chills, uncontrollable shaking & teeth chattering for 2 hours (hours 12-14 after injection), leg aches so great unable to stand. Fever measured up to 100F while on 400mg ibuprofen, temperature not taken during the intense chills.  Ongoing fever of around 100F from hours 14 - 24, chills, exhaustion, and general malaise. continued treatment with 400mg ibuprofen.  Headache and exhaustion from hours 24 post vaccine through day 5.  Ibuprofen and tylenol taken to mitigate symptoms with marginal benefit.   Minimal muscle soreness at injection site.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity, Pyrexia, SARS-CoV-2 test negative, Tremor
Clinical narrative: Intense chills, uncontrollable shaking & teeth chattering for 2 hours (hours 12-14 after injection), leg aches so great unable to stand. Fever measured up to 100F while on 400mg ibuprofen, temperature not taken during the intense chills.  Ongoing fever of around 100F from hours 14 - 24, chills, exhaustion, and general malaise. continued treatment with 400mg ibuprofen.  Headache and exhaustion from hours 24 post vaccine through day 5.  Ibuprofen and tylenol taken to mitigate symptoms with marginal benefit.   Minimal muscle soreness at injection site.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Diarrhoea, Disorientation, Dizziness, Muscle spasms
Clinical narrative: Patient returned at 9:36am after receiving first dose at 8:41 complaining of nausea and dizziness.  Vital signs taken and assessment determined Benadryl needed. Patient was given 0.4mL =(20mg) . Patients vitals checked every 5 minutes. At 10:16 patient felt better and reposted symptoms better and no dizzy spells. Pt released at 10:38. Patient called for update on 2/5/21. Patient reported feeling better this day but reports that nausea returned with cramping and lasted until 2:30 pm day of shot. Dizziness and confusion lasted until 9:00pm day of injection, disoriented until 6pm day of injection and diarrhea that lasted until 4pm day of injection. Per medical director, Dr, patient should not get second dose of Pfizer vaccine.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Patient returned at 9:36am after receiving first dose at 8:41 complaining of nausea and dizziness.  Vital signs taken and assessment determined Benadryl needed. Patient was given 0.4mL =(20mg) . Patients vitals checked every 5 minutes. At 10:16 patient felt better and reposted symptoms better and no dizzy spells. Pt released at 10:38. Patient called for update on 2/5/21. Patient reported feeling better this day but reports that nausea returned with cramping and lasted until 2:30 pm day of shot. Dizziness and confusion lasted until 9:00pm day of injection, disoriented until 6pm day of injection and diarrhea that lasted until 4pm day of injection. Per medical director, Dr, patient should not get second dose of Pfizer vaccine.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Arthralgia, Chills, Feeling abnormal, Flushing
Clinical narrative: Incredible arm/shoulder/lymph node pain starting 10 hours post-vaccination lasting about 60 hours. About 12 hours post-vaccine, uncontrollable muscle spasms began and lasted approximately 2 hours. In this time, arm/shoulder/lymph node were extremely swollen. During the muscle spasms, I experienced my first or two "attacks".  Speaking and thinking became difficult - at times I felt as though I was trapped in my own head unable to speak or move how I wanted (motor function was possible but sluggish and requiring assistance to become ambulatory). The worst of this lasted about 4 hours, though my brain remained some level of "foggy" 48 hours post-vaccination. 1-2 hours into these neurological issues, I lost the ability to feel throughout my whole body. I could tell there was a sensation on my skin, but I could not tell if it was hot/cold/pain/pressure.  I could not feel if I was swallowing, drinking water, or breathing, though I could move enough to perform these activities.  Vision was hazy during these attacks and for a while after. The worst of all these effects lasted 3-4 hours. It then took about 5-6 hours to regain all feeling, though my brain was still foggy/hazy. Heavy swelling lasted several hours, then became moderate swelling, and after 48 hours, there was little to no swelling. About 22 hours post-vaccination, I had another one of these "attacks", not including the muscle spasms. This second attack was identical to the first in every way, except it was slightly less severe.  Recuperation time was again 5-6 hours. It is currently about 70 hours post-vaccination and most symptoms except moderate arm soreness are gone. During both attacks, BP and temperature were normal, heart rate slightly elevated (80-85 bpm).  Other non-severe effects included fatigue,  slight chills/flush.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Mental impairment, Mobility decreased, Muscle spasms
Clinical narrative: Incredible arm/shoulder/lymph node pain starting 10 hours post-vaccination lasting about 60 hours. About 12 hours post-vaccine, uncontrollable muscle spasms began and lasted approximately 2 hours. In this time, arm/shoulder/lymph node were extremely swollen. During the muscle spasms, I experienced my first or two "attacks".  Speaking and thinking became difficult - at times I felt as though I was trapped in my own head unable to speak or move how I wanted (motor function was possible but sluggish and requiring assistance to become ambulatory). The worst of this lasted about 4 hours, though my brain remained some level of "foggy" 48 hours post-vaccination. 1-2 hours into these neurological issues, I lost the ability to feel throughout my whole body. I could tell there was a sensation on my skin, but I could not tell if it was hot/cold/pain/pressure.  I could not feel if I was swallowing, drinking water, or breathing, though I could move enough to perform these activities.  Vision was hazy during these attacks and for a while after. The worst of all these effects lasted 3-4 hours. It then took about 5-6 hours to regain all feeling, though my brain was still foggy/hazy. Heavy swelling lasted several hours, then became moderate swelling, and after 48 hours, there was little to no swelling. About 22 hours post-vaccination, I had another one of these "attacks", not including the muscle spasms. This second attack was identical to the first in every way, except it was slightly less severe.  Recuperation time was again 5-6 hours. It is currently about 70 hours post-vaccination and most symptoms except moderate arm soreness are gone. During both attacks, BP and temperature were normal, heart rate slightly elevated (80-85 bpm).  Other non-severe effects included fatigue,  slight chills/flush.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Peripheral swelling, Sensory loss, Swelling, Vision blurred
Clinical narrative: Incredible arm/shoulder/lymph node pain starting 10 hours post-vaccination lasting about 60 hours. About 12 hours post-vaccine, uncontrollable muscle spasms began and lasted approximately 2 hours. In this time, arm/shoulder/lymph node were extremely swollen. During the muscle spasms, I experienced my first or two "attacks".  Speaking and thinking became difficult - at times I felt as though I was trapped in my own head unable to speak or move how I wanted (motor function was possible but sluggish and requiring assistance to become ambulatory). The worst of this lasted about 4 hours, though my brain remained some level of "foggy" 48 hours post-vaccination. 1-2 hours into these neurological issues, I lost the ability to feel throughout my whole body. I could tell there was a sensation on my skin, but I could not tell if it was hot/cold/pain/pressure.  I could not feel if I was swallowing, drinking water, or breathing, though I could move enough to perform these activities.  Vision was hazy during these attacks and for a while after. The worst of all these effects lasted 3-4 hours. It then took about 5-6 hours to regain all feeling, though my brain was still foggy/hazy. Heavy swelling lasted several hours, then became moderate swelling, and after 48 hours, there was little to no swelling. About 22 hours post-vaccination, I had another one of these "attacks", not including the muscle spasms. This second attack was identical to the first in every way, except it was slightly less severe.  Recuperation time was again 5-6 hours. It is currently about 70 hours post-vaccination and most symptoms except moderate arm soreness are gone. During both attacks, BP and temperature were normal, heart rate slightly elevated (80-85 bpm).  Other non-severe effects included fatigue,  slight chills/flush.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Mobility decreased, Pain in extremity, Paralysis, Sluggishness
Clinical narrative: Incredible arm/shoulder/lymph node pain starting 10 hours post-vaccination lasting about 60 hours. About 12 hours post-vaccine, uncontrollable muscle spasms began and lasted approximately 2 hours. In this time, arm/shoulder/lymph node were extremely swollen. During the muscle spasms, I experienced my first or two "attacks".  Speaking and thinking became difficult - at times I felt as though I was trapped in my own head unable to speak or move how I wanted (motor function was possible but sluggish and requiring assistance to become ambulatory). The worst of this lasted about 4 hours, though my brain remained some level of "foggy" 48 hours post-vaccination. 1-2 hours into these neurological issues, I lost the ability to feel throughout my whole body. I could tell there was a sensation on my skin, but I could not tell if it was hot/cold/pain/pressure.  I could not feel if I was swallowing, drinking water, or breathing, though I could move enough to perform these activities.  Vision was hazy during these attacks and for a while after. The worst of all these effects lasted 3-4 hours. It then took about 5-6 hours to regain all feeling, though my brain was still foggy/hazy. Heavy swelling lasted several hours, then became moderate swelling, and after 48 hours, there was little to no swelling. About 22 hours post-vaccination, I had another one of these "attacks", not including the muscle spasms. This second attack was identical to the first in every way, except it was slightly less severe.  Recuperation time was again 5-6 hours. It is currently about 70 hours post-vaccination and most symptoms except moderate arm soreness are gone. During both attacks, BP and temperature were normal, heart rate slightly elevated (80-85 bpm).  Other non-severe effects included fatigue,  slight chills/flush.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Influenza like illness, Injection site pain, Pyrexia, Urticaria
Clinical narrative: Fever, hives, flu-like symptoms including joint pain lasting two+ days.   Pain at injection site including entire shoulder.  Only mild symptoms with first injection.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Chills, Decreased appetite, Fatigue
Clinical narrative: The morning following the vaccine, she had a fever, chills, felt really sick.  Also had a headache, a lot of muscle and joint pain.  She was nauseous, no appetite, and abdominal pain.  Very tired as well.  She did not take anything for it, just slept and by the morning of 2/6/21 was still tired, but not sick anymore and able to eat some, was not able to prior to this.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, Nausea, Pyrexia
Clinical narrative: The morning following the vaccine, she had a fever, chills, felt really sick.  Also had a headache, a lot of muscle and joint pain.  She was nauseous, no appetite, and abdominal pain.  Very tired as well.  She did not take anything for it, just slept and by the morning of 2/6/21 was still tired, but not sick anymore and able to eat some, was not able to prior to this.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Feeling abnormal, Nausea, Vomiting
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA Beginning at 3 am, I became exceedingly nauseated; followed by violent vomiting and extreme diarrhea. Unable to keep down water until now 11:45 am, 2/8. Fatigue and fogginess throughout.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dizziness postural, Erythema, Headache
Clinical narrative: At about 12 pm day of immunization patient began having the following symptoms: redness to neck and front chest,  injection site ( right arm) redness , itching, rash below and above injection, reports blood pressure 169/96 ( checked at site ) , dizziness with standing, denied shortness of breath or chest pain at that time.  En route home began having mid sternal chest pain , radiated to left side of chest, checked blood pressure at home 175/100.  Patient states took additional Benadryl 25mg PO .  After Benadryl chest pain subsided.  At this time reports headache, dizziness, vertigo, chills , and fever.  Vital signs stable, patient aaox3, report to Occupational Health provider.  No obvious distress noted.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Pyrexia, Vertigo
Clinical narrative: At about 12 pm day of immunization patient began having the following symptoms: redness to neck and front chest,  injection site ( right arm) redness , itching, rash below and above injection, reports blood pressure 169/96 ( checked at site ) , dizziness with standing, denied shortness of breath or chest pain at that time.  En route home began having mid sternal chest pain , radiated to left side of chest, checked blood pressure at home 175/100.  Patient states took additional Benadryl 25mg PO .  After Benadryl chest pain subsided.  At this time reports headache, dizziness, vertigo, chills , and fever.  Vital signs stable, patient aaox3, report to Occupational Health provider.  No obvious distress noted.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Local reaction to COVID vaccine.  11 cm length x 14 cm width circular "bulls eye" circular area to left upper arm, warm, red, raised, non tender, pt reports some/minor itching.  TX:  hydro-cortisone cream 1% BID x 1 week, benadryl 25mg PRN itching - no scratching, F/U if no improvement.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Faecal volume increased
Clinical narrative: Extra Large Watery stool
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Approximately 24 hours after receiving the vaccine, left arm punctured area became red, hot, tight and sore. The 2nd day after vaccination the area was somewhat itchy for that day. Area is increasing in size daily. Currently 5 & 3/4 inches in height by 7 & 1/2 inches in width. 18 hours after vaccination began feeling general fatigue, chills and body aches which continue. Benadryl is not really helping. Tylenol & Ibuprofen help for the body aches. When she gets bee stings it's almost the same reaction. When she takes Penicillin she developed hives and rashes. She has never been prescribed an epi-pen. Denies any breathing or vision changes. No recent changes in medication. Advised consult w/ her M.D. A.S.A.P.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site warmth, Pain
Clinical narrative: Approximately 24 hours after receiving the vaccine, left arm punctured area became red, hot, tight and sore. The 2nd day after vaccination the area was somewhat itchy for that day. Area is increasing in size daily. Currently 5 & 3/4 inches in height by 7 & 1/2 inches in width. 18 hours after vaccination began feeling general fatigue, chills and body aches which continue. Benadryl is not really helping. Tylenol & Ibuprofen help for the body aches. When she gets bee stings it's almost the same reaction. When she takes Penicillin she developed hives and rashes. She has never been prescribed an epi-pen. Denies any breathing or vision changes. No recent changes in medication. Advised consult w/ her M.D. A.S.A.P.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Heart rate increased
Clinical narrative: Patient had an increase in heart rate and anxiety post administration of vaccine. EMS was called on site.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Itching and swelling in hands and feet.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Faeces discoloured
Clinical narrative: dark all black  stool  for day of vaccine shot and Sunday again
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Fatigue, Pain, Pyrexia, Rash pruritic
Clinical narrative: On 1st day after shot (Fri), felt achy, tired and feverish. I was recovering from that when I broke out in a very itchy rash with several blisters on torso Saturday night. Thinking that it might be an allergic reaction, I took Zyrtec and went to bed. It was about the same on Sunday but by today (Monday) it is clearing up.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Lip swelling, Swollen tongue
Clinical narrative: pt did not have a reaction after first dose of moderna 12/28/2021 025j20a. Today, 02/08/2021: 11:57am moderna shot given. 12:00pm 25mg Benadryl given to patient to chew, and one EpiPen 0.3mg given to patient on right lateral thigh. Patient complains of severe trouble breathing, swollen lips, and swollen tongue, patient was given oxygen through a mask. Patient did not improve, and needed a re-dose of 0.3mg EpiPen into the left lateral thigh, and another 25mg Benadryl for patient to chew. 12:06pm patient has not improved, 98% o2 sat, 73bpm, and another 0.3mg EpiPen administered to right lateral thigh. 12:07pm 96% o2 sat, 106bpm, 152/98mmHg, and ambulance arrived and took patient to ER.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Diarrhoea, Diarrhoea haemorrhagic, Dizziness
Clinical narrative: Approx. 36 hours after injection, fever spiked very quickly. Eyes became blood red; severe stomach cramps; for 24 more hours had diarrhea, watery, bloody, uncontrolled; 104F fever; severe body aches; Dizzy. 3" red oval on left arm at injection site; hives at site as well. Three days after injection,  still itchy, very sore in abdomen, fever of 101.2F  Still achey and missing work due to symptoms.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site urticaria, Ocular hyperaemia, Pain, Pruritus
Clinical narrative: Approx. 36 hours after injection, fever spiked very quickly. Eyes became blood red; severe stomach cramps; for 24 more hours had diarrhea, watery, bloody, uncontrolled; 104F fever; severe body aches; Dizzy. 3" red oval on left arm at injection site; hives at site as well. Three days after injection,  still itchy, very sore in abdomen, fever of 101.2F  Still achey and missing work due to symptoms.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Approx. 36 hours after injection, fever spiked very quickly. Eyes became blood red; severe stomach cramps; for 24 more hours had diarrhea, watery, bloody, uncontrolled; 104F fever; severe body aches; Dizzy. 3" red oval on left arm at injection site; hives at site as well. Three days after injection,  still itchy, very sore in abdomen, fever of 101.2F  Still achey and missing work due to symptoms.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Catheter placement, Dizziness, Posture abnormal, Respiratory rate increased, Skin discolouration
Clinical narrative: 3:15 - Pt was leaning against wall c/o being dizzy and going to pass out - Pt was moved to reclining position - BP 144/100, RR 44, HR 120 - No itching ect. - Respirations rapid - O2 62 - Cannula applied - Pt continued c/o thinking he would pass out - Color pink - 3:15 1 cc Benedryl administered in R arm - 3:27 Epi 1 dose (0.7 cc) administered in R thigh - 3:30 EMS arrived - 3:34 EMS transferred pt to Medical Center
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Pruritus
Clinical narrative: Red itchy firmness in my left arm
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy, we to PCP and received a steroid dose pack and Valcyclevaier.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Developed a minor red itchy rash within inches of the injection site. After 2 days applied 1% hydrocortisone to the affected area 3 times a day. Today, 02/08 2021, the itching and redness have substantially declined to the point that I have discontinued the hydrocortisone treatment.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: administration of ROTATEQ after temperature excursion; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.  On 11-JAN-2021, the patient was vaccinated with improperly stored after temperature excursion dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1742457, expiration date was reported as 16-FEB-2022, but upon internal review was determined as 06-JAN-2022, 2 ml, administered orally for prophylaxis. Temperature was 1.3 Celsius degree for 19 minutes. Data logger was involved. The outcome was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: temperature excursion for V ARlV AX/administered to patients; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On 04-JAN-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T010313, expiration date 24-MAR-2022, dose 1, 0.5 milliliter, administered subcutaneous for prophylaxis. Temperature was 32.4 Fahrenheit degrees (F) for 4 hours. There was no previous temperature excursion. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2101USA010446: US-009507513-2101USA009977: US-009507513-2101USA010358: US-009507513-2101USA010348:
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: administration of ROTATEQ after temperature excursion; This spontaneous report was received from a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.  On 11-JAN-2021, the patient was vaccinated with improperly stored (after temperature excursion) rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1742457, expiration date was reported as 16-FEB-2022, but upon internal review was determined as 06-JAN-2022, 2 milliliter, administered orally for prophylaxis. Temperature was 1.3 Celsius degree (C) for 19 minutes. There was no previous temperature excursion. Data logger was involved.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE/PQC reported; expired dose of rotateq was given to a patient; This spontaneous report was received from a nurse and refers to a patient of unknown age. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 26-JAN-2021, the patient was vaccinated with expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # S006050, expiration date was reported as 12-DEC-202, but upon internal validation was established as 12-DEC-2020) (exact dose, dose number, route of administration and anatomical location were not reported) for prophylaxis. Caller verified that there were no known temperature excursions. No additional adverse events were reported.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness
Clinical narrative: Felt fine after the shot, shoveled some snow mid to late  afternoon. Felt woozy around nine, check BP and recorded results below. 2nd shot scheduled for 2/22,. Apparently this could have been a rare reaction, any input re the second dose would be appreciated. Per website, " Among the 21,621 people in the trial who received BNT162b2, four related serious adverse events were reported: shoulder injury related to vaccine administration, right axillary lymph adenopathy, paroxysmal ventricular arrhythmia and right leg paresthesia."
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine was administered on 25JAN2021; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 25-JAN-2021, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) vial, lot # T004378 was confirmed to be valid, expiration date was reported as 31-OCT-2022, but upon internal validation process, it was established as 01-NOV-2022 (dose, route of administration and anatomical location were not reported). Administered dose of vaccine was stored in the temperature of above 9 degrees Celsius (C) (13.4 degrees C) for 2 hours 9 minutes.  There were no previous temperature excursions reported. The improper storage was recorded by digital data logger.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient is a 14 year old who received the first dose of GARDASIL9 on 19-OCT-2020 and the second dose today, 29-JAN-2021, but the patient should have received the second dose 6 months from the first dose; This spontaneous report was received from a medical assistant regarding a 14-year old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions, allergies, and concomitant therapies were not provided.   On 19-OCT-2020, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (route of administration, vaccination scheme, anatomical site, lot number and expiration date were not provided). On 29-JAN-2021 (reported as "today"), the patient received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter for prophylaxis (route of administration, vaccination scheme, anatomical site was not reported) the lot number 1867291 with a expiration date of 11-SEP-2022 was confirmed to be non valid. However, the patient should have received the second dose six months form the first dose (Inappropriate schedule of product administration). No additional adverse event details.
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional AEs reported; GARADASIL 9 given to a 5 year old female; This spontaneous report was received from a nurse and refers to a 5 years old female patient. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On 29-JAN-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, prefilled syringe, 0.5 milliliter, lot # 1586749 was confirmed to be valid, expiration date was 13-FEB-2021 (route of administration and anatomical location were not reported) for prophylaxis (product administered to patient of inappropriate age). No additional adverse events was reported. No further information was provided. 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: 1586749; expirationdate: 13-FEB-2021; 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: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: She reported that a child may have received VAQTA too early; She reported that a child may have received VAQTA too early; This spontaneous report was received from a consumer and refers to a child patient of unknown age. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On an unknown date, the patient may have received vaccinated with hepatitis a vaccine, inactivated (VAQTA) (formulation, dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age and circumstance or information capable of leading to medication error). No additional information was available.
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Completed suicide
Clinical narrative: Suicide
Sex: M
Vaccine: MMR
Symptoms: Autism spectrum disorder, Seizure
Clinical narrative: autistic; Seizures; bad reactions after injections; This spontaneous report was received from a patient's mother and refers to an 18-month-old male patient. It was reported that the patient was adult at the time of the report. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) for prophylaxis (strength, dose, route of administration, lot number and expiration date were not provided.  On an unknown date, the patient experienced bad reactions and seizures after injection. It was also reported, that the patient was autistic from an unknown date. The outcome of the events was unknown.   The causality assessment between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) was not provided. It was reported that the events occurred due to thiomersal (reported as thimerosal).  Upon internal review, the events of autism spectrum disorder and seizures were considered to be medically significant.
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Back pain, Dysmenorrhoea, Polycystic ovaries
Clinical narrative: Polycystic Ovarian Syndrome; has a chronic lower back pain; severe menstrual cramps.; This case was reported by a consumer via interactive digital media and described the occurrence of polycystic ovarian syndrome in a 19-year-old female patient who received HPV 16-18 (HPV vaccine) for prophylaxis.   On an unknown date, the patient received HPV vaccine. On an unknown date, 7 years after receiving HPV vaccine, the patient experienced polycystic ovarian syndrome, chronic back pain and menstrual cramp. On an unknown date, the outcome of the polycystic ovarian syndrome, chronic back pain and menstrual cramp were not recovered/not resolved.   It was unknown if the reporter considered the polycystic ovarian syndrome, chronic back pain and menstrual cramp to be related to HPV vaccine.  Additional information was provided as follows: The case was reported by the patient's mother. The age at vaccination was not reported, but could be 19 or 20 years. The patient received HPV vaccine and experienced polycystic ovarian syndrome, chronic lower back pain and severe menstrual cramps. The reporter mentioned that, HPV vaccine had been used to sterilize the girls and she wished, she could have known this 7 years ago when her daughter was vaccinated. The reporter was regretting so bad, getting her daughter vaccinated at the age of 12. The case is linked with the case number- US2020AMR247406, reported by the same reporter ; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR247406:same reporter
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Lymph node pain, Musculoskeletal stiffness, Neck pain, Pyrexia
Clinical narrative: 02/06/2021: 30 hours after injection, mild stiff neck began on right side. 02/07/2021: Neck pain traveled up to lower skull, around to front of neck including lymph node. 02/08/2021: Pain became severe, swallowing became difficult and painful to lymph node. Developed a fever of 100.3 an hour after taking 2 Tylenol.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Pain in extremity
Clinical narrative: Chills; Stomach upset; Sore arm; This case was reported by a consumer and described the occurrence of chills in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced chills, upset stomach and pain in arm. On an unknown date, the outcome of the chills, upset stomach and pain in arm were unknown.   It was unknown if the reporter considered the chills, upset stomach and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was patient's father. It was reported that patient received the 1st dose Shingrix about a week or so ago and experienced chills, stomach upset and a sore arm. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020246459:Same reporter.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: When the nurse the nurse pulled siringe out,  blood abs assuming vaccine squirted out.  A lot.   Should I get revaccinated?
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Pain in extremity
Clinical narrative: Chills; Stomach upset; Sore arm; This case was reported by a consumer and described the occurrence of chills in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received the 1st dose of Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced chills, upset stomach and pain in arm. On an unknown date, the outcome of the chills, upset stomach and pain in arm were unknown.   It was unknown if the reporter considered the chills, upset stomach and pain in arm to be related to Shingrix.  Additional details were provided as follows: The reporter was the father in law of the patient. The patient was either 57 or 58 years old. The age at vaccination was not reported, however it could be 57 or 58 years. The reporter had very limited information. The patient received the 1st dose a week or so ago from the time of reporting and experienced chills, stomach upset and a sore arm.  The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020246458:Same reporter.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Gait disturbance, Mobility decreased
Clinical narrative: Difficulty Walking; unable to get out of bed; Weakness; This case was reported by a consumer and described the occurrence of walking difficulty in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th December 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 10th December 2020, less than a day after receiving Shingrix, the patient experienced weakness. On 11th December 2020, the patient experienced walking difficulty and mobility decreased. On an unknown date, the outcome of the walking difficulty, mobility decreased and weakness were not recovered/not resolved.   It was unknown if the reporter considered the walking difficulty, mobility decreased and weakness to be related to Shingrix.  Additional details were provided as follows: The case was reported by the daughter of the patient. The patient received Shingrix in left deltoid and on same night the patient complained of weakness. The patient was unable to get out of bed next morning due to severe weakness. The patient needed assistance getting out of bed to make it to the bathroom and had difficulty walking.