chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Feeling abnormal, Hyperhidrosis, Pain, Pallor
Clinical narrative: Systemic: Death-Severe, Additional Details: Patient (Resident of facility) received COVID19 2nd dose vaccine at approximately 11am on 2/21. Pharmacy administered the vaccine through the LTC partnership program. Patient had no issues following vaccine. The director of the facility called me on 2.22 to update me on the situation. Per facility, at 8PM patient complained of body aches and chills. At 12AM patient had temperature of 102.2, vomiting, and trouble breathing. Paramedics arrived at 0040. Patient passed away at 0110 at hospital.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Systemic: Death-Severe, Additional Details: Patient (Resident of facility) received COVID19 2nd dose vaccine at approximately 11am on 2/21. Pharmacy administered the vaccine through the LTC partnership program. Patient had no issues following vaccine. The director of the facility called me on 2.22 to update me on the situation. Per facility, at 8PM patient complained of body aches and chills. At 12AM patient had temperature of 102.2, vomiting, and trouble breathing. Paramedics arrived at 0040. Patient passed away at 0110 at hospital.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Chills, Death, Dyspnoea, Pain
Clinical narrative: Systemic: Death-Severe, Additional Details: Patient (Resident of facility) received COVID19 2nd dose vaccine at approximately 11am on 2/21. Pharmacy administered the vaccine through the LTC partnership program. Patient had no issues following vaccine. The director of the facility called me on 2.22 to update me on the situation. Per facility, at 8PM patient complained of body aches and chills. At 12AM patient had temperature of 102.2, vomiting, and trouble breathing. Paramedics arrived at 0040. Patient passed away at 0110 at hospital.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pruritus, Skin lesion
Clinical narrative: Error: Infection / Cellulitis (diagnosed by MD)
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cellulitis, Infection
Clinical narrative: Error: Infection / Cellulitis (diagnosed by MD)
Age: 1.25
Sex: M
Vaccine: DTAP, FLU4, HIBV, PNC13, DTAP, FLU4, HIBV, PNC13
Symptoms: Anion gap, Full blood count abnormal, Haemoglobin decreased, Immediate post-injection reaction, Metabolic function test normal
Clinical narrative: Patient in distress after receiving immunizations D Tap, pneumonia, Hib, Flu. RN arrived to see patient laying on exam room table, and appeared to be having a seizure. 911 was called. Monitored for approximately 4 minutes. Breathing rapidly at first then transitioned to shallow breathing and dusky around mouth, body limp at this time. Ambu bag applied with oxygen. O2 sat 100%, patient started to become more responsive. Respirations improved, changed oxygen to blown by oxygen. EMS arrived. Patient more alert and transferred to ER.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU4, HIBV, PNC13, DTAP, FLU4, HIBV, PNC13
Symptoms: Platelet count increased, Seizure, White blood cell count increased
Clinical narrative: Patient in distress after receiving immunizations D Tap, pneumonia, Hib, Flu. RN arrived to see patient laying on exam room table, and appeared to be having a seizure. 911 was called. Monitored for approximately 4 minutes. Breathing rapidly at first then transitioned to shallow breathing and dusky around mouth, body limp at this time. Ambu bag applied with oxygen. O2 sat 100%, patient started to become more responsive. Respirations improved, changed oxygen to blown by oxygen. EMS arrived. Patient more alert and transferred to ER.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU4, HIBV, PNC13, DTAP, FLU4, HIBV, PNC13
Symptoms: Emotional distress, Hypopnoea, Hypotonia, Respiratory rate increased, Seizure
Clinical narrative: Patient in distress after receiving immunizations D Tap, pneumonia, Hib, Flu. RN arrived to see patient laying on exam room table, and appeared to be having a seizure. 911 was called. Monitored for approximately 4 minutes. Breathing rapidly at first then transitioned to shallow breathing and dusky around mouth, body limp at this time. Ambu bag applied with oxygen. O2 sat 100%, patient started to become more responsive. Respirations improved, changed oxygen to blown by oxygen. EMS arrived. Patient more alert and transferred to ER.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU4, HIBV, PNC13, DTAP, FLU4, HIBV, PNC13
Symptoms: Skin discolouration
Clinical narrative: Patient in distress after receiving immunizations D Tap, pneumonia, Hib, Flu. RN arrived to see patient laying on exam room table, and appeared to be having a seizure. 911 was called. Monitored for approximately 4 minutes. Breathing rapidly at first then transitioned to shallow breathing and dusky around mouth, body limp at this time. Ambu bag applied with oxygen. O2 sat 100%, patient started to become more responsive. Respirations improved, changed oxygen to blown by oxygen. EMS arrived. Patient more alert and transferred to ER.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Lymphadenopathy, Pain, Pain in extremity
Clinical narrative: Received vaccine 1/15/21. 3 days later, developed axillary LAD ipsilateral to vaccine administration. The next day, developed upper back pain. Symptoms have persisted for >1 month and not responding to OTC pain medication.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Lymphadenopathy
Clinical narrative: Received vaccine 1/15/21. 3 days later, developed axillary LAD ipsilateral to vaccine administration. The next day, developed upper back pain. Symptoms have persisted for >1 month and not responding to OTC pain medication.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Large red rash similar to COVID arm side effect appeared at the injection site. This was almost a week later.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Purple mark around injection site . Directly below the site, there is a large red patch that is swollen and warm to the touch.  I had a red patch and swelling after the first dose also. That one is now a faint purple.  Same arm.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blood insulin, Diabetes mellitus, Dialysis, Pancreatitis, Renal failure
Clinical narrative: Symptoms started within 3 days of getting the shot. As per Hospital : severe UTI  -   cleared up completely severe  Pancreatitis  -   cleared up completely Severe diabetes  -  placed on high insulin severe kidney failure  -  placed on dialysis
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Symptoms started within 3 days of getting the shot. As per Hospital : severe UTI  -   cleared up completely severe  Pancreatitis  -   cleared up completely Severe diabetes  -  placed on high insulin severe kidney failure  -  placed on dialysis
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Chillblains, Chills, Fatigue
Clinical narrative: Immediate soar arm, next day horrible body/joint/head aches, intermittent fever up to 103.4 degrees F, mind fog, severe malaise and fatigue, chills. All those lasted about 4 days. They really bad ?COVID toes? that were like chlybains and now 3 weeks later look like petechiae on top of toes (reddish - purple , a few are bleeding). By the way I had Mono 13 months ago that was pretty bad and had COVID in November not that severe at all.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Infectious mononucleosis, Limb discomfort, Macule
Clinical narrative: Immediate soar arm, next day horrible body/joint/head aches, intermittent fever up to 103.4 degrees F, mind fog, severe malaise and fatigue, chills. All those lasted about 4 days. They really bad ?COVID toes? that were like chlybains and now 3 weeks later look like petechiae on top of toes (reddish - purple , a few are bleeding). By the way I had Mono 13 months ago that was pretty bad and had COVID in November not that severe at all.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain, Petechiae, Pyrexia, Skin haemorrhage
Clinical narrative: Immediate soar arm, next day horrible body/joint/head aches, intermittent fever up to 103.4 degrees F, mind fog, severe malaise and fatigue, chills. All those lasted about 4 days. They really bad ?COVID toes? that were like chlybains and now 3 weeks later look like petechiae on top of toes (reddish - purple , a few are bleeding). By the way I had Mono 13 months ago that was pretty bad and had COVID in November not that severe at all.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Immediate soar arm, next day horrible body/joint/head aches, intermittent fever up to 103.4 degrees F, mind fog, severe malaise and fatigue, chills. All those lasted about 4 days. They really bad ?COVID toes? that were like chlybains and now 3 weeks later look like petechiae on top of toes (reddish - purple , a few are bleeding). By the way I had Mono 13 months ago that was pretty bad and had COVID in November not that severe at all.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia, Paraesthesia oral, Pharyngeal swelling
Clinical narrative: Numbness and tingling of face and lips that got progressively worse. Throat swelling
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site scab, Pain in extremity
Clinical narrative: Sore arm on days 1,2,3.  On day 5 I noticed a scab or almost lesion where the shot was given  Today on day 6 I am achy on my left side only. Mostly my neck, arm and also my left side thigh.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: I had the virus in August of 2020 for 30 days until symptom free.  ON 2/6/2021 received first vaccine injection.  within 3 minutes a light headache started.  That evening, rash and itching on right fore-arm and under chin. took benedryl. Woke at 3:30 am on 2/7 not feeling well and left arm very sore and could not touch.  6:30 am - chills with severe body shaking and 101 temp.  7:30 am 102.2  took tylenot 8 hr 650 mg. Oxygen at 96, heart rate at 76 and BP 117/68. 8:00 am 101.9 temp. 10 am 100.6 temp. 1:30 pm 102.9 temp. 2:00 pm 103.3  Took Tylenol, extra strength 2 tabs. 8:30 pm used inhaler due to chest pains  101.3 temp. took benedryl.  Oxygennn @98  HR-82 BP 145/77.  11.00 pm 103.3 temp. took 2 tylenol.  Mon 8:00 Monday am continued/ 100.2 temp  oxygen 97  HR-70; 99.2 temp  BP 110/71.  7 pm. took Benedryl for congestion.   Quit taking stats.  Fatigue and rest took play at this point.  Since then have had intermittent low grade fever in 99.2 to 99.9.  Same with headache and extreme fatigue.  Have high risk husband that I take care of .  He had his first vaccine at same time.  No side effect at all.  I am scheduled for 2nd vaccine on March 6th.  I am very apprehensive about taking it with this reaction.  Please advise/recommend if I should proceed.  My PCP stated that these reactions were evidence the vaccine is working.  Is this because I had the virus???  Both the virus and vaccine have been really hard on me.  I am usually a very active person and since August, I have been struggling with fatigue.  First time in life.   Thank you.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Tremor
Clinical narrative: I had the virus in August of 2020 for 30 days until symptom free.  ON 2/6/2021 received first vaccine injection.  within 3 minutes a light headache started.  That evening, rash and itching on right fore-arm and under chin. took benedryl. Woke at 3:30 am on 2/7 not feeling well and left arm very sore and could not touch.  6:30 am - chills with severe body shaking and 101 temp.  7:30 am 102.2  took tylenot 8 hr 650 mg. Oxygen at 96, heart rate at 76 and BP 117/68. 8:00 am 101.9 temp. 10 am 100.6 temp. 1:30 pm 102.9 temp. 2:00 pm 103.3  Took Tylenol, extra strength 2 tabs. 8:30 pm used inhaler due to chest pains  101.3 temp. took benedryl.  Oxygennn @98  HR-82 BP 145/77.  11.00 pm 103.3 temp. took 2 tylenol.  Mon 8:00 Monday am continued/ 100.2 temp  oxygen 97  HR-70; 99.2 temp  BP 110/71.  7 pm. took Benedryl for congestion.   Quit taking stats.  Fatigue and rest took play at this point.  Since then have had intermittent low grade fever in 99.2 to 99.9.  Same with headache and extreme fatigue.  Have high risk husband that I take care of .  He had his first vaccine at same time.  No side effect at all.  I am scheduled for 2nd vaccine on March 6th.  I am very apprehensive about taking it with this reaction.  Please advise/recommend if I should proceed.  My PCP stated that these reactions were evidence the vaccine is working.  Is this because I had the virus???  Both the virus and vaccine have been really hard on me.  I am usually a very active person and since August, I have been struggling with fatigue.  First time in life.   Thank you.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood potassium decreased, Blood test, Cyanosis, Dyspnoea
Clinical narrative: Slight fever, loss of strength, headache, extreme difficulty breathing.   Oxygen, steriods, antibiotics for UTI, Cyanotic according to EMS and saturating at 80s at home.  No accute pathology but  hyperinflated WBC was 19.  Sent home with oxygen
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Headache, Oxygen saturation decreased, Pyrexia, Ventilation/perfusion scan
Clinical narrative: Slight fever, loss of strength, headache, extreme difficulty breathing.   Oxygen, steriods, antibiotics for UTI, Cyanotic according to EMS and saturating at 80s at home.  No accute pathology but  hyperinflated WBC was 19.  Sent home with oxygen
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count increased
Clinical narrative: Slight fever, loss of strength, headache, extreme difficulty breathing.   Oxygen, steriods, antibiotics for UTI, Cyanotic according to EMS and saturating at 80s at home.  No accute pathology but  hyperinflated WBC was 19.  Sent home with oxygen
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Injection site pain
Clinical narrative: Soreness at injection site and fatigue within several hours; headache next morning with slight dizziness
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site joint pain, Injection site muscle weakness, Injection site pain
Clinical narrative: The immediate 48 hours after the second dose was not a problem. It was around 72 hours in which acute muscle soreness occurred at the injection site on my right deltoid. I thought it would resolve like the first dose after three or four days, but this seem to last longer and then it mysteriously begin to travel down my arm. It seems like every one or two days it went more distal down my right upper extremity. It first went from my deltoid to my bicep and tricep. And then a couple days later it was in my elbow and forearm. Now it has been in my elbow for weeks leaving me with weakness and pain that nothing seems to help improve it. It?s like it is in my joint at my right elbow. There is a very specific soreness and pain which has cost me a significant discomfort and weekend my strength and the entire arm.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular
Clinical narrative: Rash with raised bumps. No itch however if I scratch them they bleed.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pelvic pain
Clinical narrative: Intense joint pain in hips and pelvis, especially left side. Pain progressed throughout the day making it difficult to move.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose decreased
Clinical narrative: After some eight hours after the injection patient's glucose level dropped to a unsafe level. (48) After eating dinner, some three hours later, patient took Jardiance 25mg. and one Tylenol.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Erythema, Lip pruritus, Lip swelling
Clinical narrative: First as expected arm sore apx 5 hrs post, at 930 pm extreme upper abdominal pain (similar to pancreatitis), followed by continuous nausea, vomiting for 1.5 days eased finallyby Zofran. On day 2 my lips began to swell and were itchy, by day 3 they were very swollen, took benadryl every 8 hrs and by day 5 today they are fairly normal but still sore. My arm also swelled and spread to arm pit and was very hot and red. The redness has mostly gone, the swelling has lessened but not gone. Still sore and itchy. Still pretty run down and no energy. My cousin and I live together and were vaccinated at the same time and both had these symptoms except the lips swelling.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oedema peripheral, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: First as expected arm sore apx 5 hrs post, at 930 pm extreme upper abdominal pain (similar to pancreatitis), followed by continuous nausea, vomiting for 1.5 days eased finallyby Zofran. On day 2 my lips began to swell and were itchy, by day 3 they were very swollen, took benadryl every 8 hrs and by day 5 today they are fairly normal but still sore. My arm also swelled and spread to arm pit and was very hot and red. The redness has mostly gone, the swelling has lessened but not gone. Still sore and itchy. Still pretty run down and no energy. My cousin and I live together and were vaccinated at the same time and both had these symptoms except the lips swelling.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: First as expected arm sore apx 5 hrs post, at 930 pm extreme upper abdominal pain (similar to pancreatitis), followed by continuous nausea, vomiting for 1.5 days eased finallyby Zofran. On day 2 my lips began to swell and were itchy, by day 3 they were very swollen, took benadryl every 8 hrs and by day 5 today they are fairly normal but still sore. My arm also swelled and spread to arm pit and was very hot and red. The redness has mostly gone, the swelling has lessened but not gone. Still sore and itchy. Still pretty run down and no energy. My cousin and I live together and were vaccinated at the same time and both had these symptoms except the lips swelling.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: After three days my injection site started swelling and itching  Now it's gotten worse and it's been 7 days.  I have a hot red swollen patch about the size of a half dollar that itches.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Dry throat, Ear pain, Fatigue
Clinical narrative: Lightheaded, headache, upset stomach, sore arm , within 30 minutes post vaccine. tired. Poor sleep quality at night after vaccine. Chills, Fever and scratchy dry throat began about 10 hours post vaccine.   Fever of 100.4 lasted about 18 hours.  Loose stools after about  24 hours. Ear ache and tender neck lymph nodes began after 24 hours. dry throat lasted 48 to 72 hours.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Lymph node pain, Pain in extremity, Poor quality sleep
Clinical narrative: Lightheaded, headache, upset stomach, sore arm , within 30 minutes post vaccine. tired. Poor sleep quality at night after vaccine. Chills, Fever and scratchy dry throat began about 10 hours post vaccine.   Fever of 100.4 lasted about 18 hours.  Loose stools after about  24 hours. Ear ache and tender neck lymph nodes began after 24 hours. dry throat lasted 48 to 72 hours.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Throat irritation
Clinical narrative: Lightheaded, headache, upset stomach, sore arm , within 30 minutes post vaccine. tired. Poor sleep quality at night after vaccine. Chills, Fever and scratchy dry throat began about 10 hours post vaccine.   Fever of 100.4 lasted about 18 hours.  Loose stools after about  24 hours. Ear ache and tender neck lymph nodes began after 24 hours. dry throat lasted 48 to 72 hours.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Paraesthesia oral
Clinical narrative: 54 y o female c/o hives to face _ none seen) , lip tingling and 5/10  chest pain   Given 50 mg of Benadryl IM right deltoid at 204 pm  and placed on 10 lpm O2 via mask at 205 pm  O2 reduced to 8 lpm via mask after 2/10 chest pain Lungs CTA bilaterally non-labored breathing.  Client had used albuterol PTA  Client on room air at 234 pm and feeling good.  Denies any lip tingling  Chest pain resolved.  VSS 102/78 70 24   Client agreed to follow up with PCP prior to 2nd CoVid vaccine.     Meds:  Zyrtex, albuterol, Advair, Flonase, singular  Allergies:  morphine, lidocaine, EES Client DC;d home stable NAD MAEW non-labored breathing
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pain, Rash erythematous
Clinical narrative: 2/02/2021 developed shingles ( herpes roster) first time in my life. Severe pain, red bumps on right back and front
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Catheterisation cardiac abnormal, Coronary artery dissection, Myocardial infarction, Stent placement, Troponin increased
Clinical narrative: 37yo male with no cardiac risk factors had spontaneous dissection of rt coronary artery 5 days post vaccination w associated MI requiring 3 drug eluting stents and "extreme" clot burden on cath requiring tPA.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Ventricular extrasystoles
Clinical narrative: 37yo male with no cardiac risk factors had spontaneous dissection of rt coronary artery 5 days post vaccination w associated MI requiring 3 drug eluting stents and "extreme" clot burden on cath requiring tPA.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injected limb mobility decreased, Injection site pain, Pain, Sluggishness
Clinical narrative: Body aches and chills the following morning after receiving the vaccination.  I was very sluggish and remained in bed for the majority of the day.    I also had a lot of pain at the injection site and couldn't lift my arm.  Tylenol resolved the issues for the most part but it was only effective for about three hours prompting me to wait an additional 2-3 hours with the symptoms.   This lasted 24 hours and I felt good as new the following day with minor pain at the injection site.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, Urticaria
Clinical narrative: Severe bodyaches headache fever of 102.4 chills and two days after receiving the injection broke out in hives
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthma, Breath sounds abnormal, Chest X-ray, Chest X-ray abnormal, Localised infection
Clinical narrative: Localized super infection occurred 11 days after first receiving vaccine. Diagnosed with asthma soon after and hospitalized for the first time on 2/13 for severe respiratory complications. Prescribed nebulizer treatment at home with albuteral, montekulast, prednisone, and qvar inhaler. Went to urgent care today  in hopes to avoid hospital bills. Chest xray showed some fluid. Prescribed iputropium for my nebulizer treatment and also azithromyacin to stall any infection. Lets hope no more hospital visits. Waiting to hear back from pulmonologist to schedule appt.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pleural effusion, Respiratory disorder, Superinfection
Clinical narrative: Localized super infection occurred 11 days after first receiving vaccine. Diagnosed with asthma soon after and hospitalized for the first time on 2/13 for severe respiratory complications. Prescribed nebulizer treatment at home with albuteral, montekulast, prednisone, and qvar inhaler. Went to urgent care today  in hopes to avoid hospital bills. Chest xray showed some fluid. Prescribed iputropium for my nebulizer treatment and also azithromyacin to stall any infection. Lets hope no more hospital visits. Waiting to hear back from pulmonologist to schedule appt.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthma, Bacterial infection, Blood test normal, Chest X-ray abnormal, Computerised tomogram thorax normal
Clinical narrative: Localized super infection occurred 11 days after first receiving vaccine. Diagnosed with asthma soon after and hospitalized for the first time on 2/13 for severe respiratory complications. Prescribed nebulizer treatment at home with albuteral, montekulast, prednisone, and qvar inhaler. Went to urgent care today  in hopes to avoid hospital bills. Chest xray showed some fluid. Prescribed iputropium for my nebulizer treatment and also azithromyacin to stall any infection. Lets hope no more hospital visits. Waiting to hear back from pulmonologist to schedule appt.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Dyspnoea, Peripheral swelling
Clinical narrative: Localized super infection occurred 11 days after first receiving vaccine. Diagnosed with asthma soon after and hospitalized for the first time on 2/13 for severe respiratory complications. Prescribed nebulizer treatment at home with albuteral, montekulast, prednisone, and qvar inhaler. Went to urgent care today  in hopes to avoid hospital bills. Chest xray showed some fluid. Prescribed iputropium for my nebulizer treatment and also azithromyacin to stall any infection. Lets hope no more hospital visits. Waiting to hear back from pulmonologist to schedule appt.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: After first dose, got hives around injection site on left arm about 12 days later. Went away over night, but reappeared briefly a couple days later. After second dose, got same hives around injection site a couple days after vaccination. Comes and goes. On 2/22 got hives on left and right arms, back, and chest.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: Rash at the injection site, COVID arm, appearing one week after injection
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Approximately 12 days post vaccination, vaccination spot became swollen, red, and firm, slightly bothersome and itchy
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Left arm/shoulder. Large red itchy rash at injection site.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Lethargy, Muscle spasms, Nausea
Clinical narrative: Nausea, vomiting, cramping, fever, chills, lethargy, headaches, and body aches
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Nausea, vomiting, cramping, fever, chills, lethargy, headaches, and body aches
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Myalgia, Temperature intolerance
Clinical narrative: Mild fever (no higher than 99.5F), fatigue, muscle aches, injection site pain all started about 15 hours after vaccination and lasted about 12 hours.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza, Pain, Somnolence
Clinical narrative: acute flu lasting 3 days followed by 1 day with lighter symptoms.  The 3 days included acute  pain,fatigues,sleepiness,chills, body aches . On day 2 about 28 hours after taking the vaccine I walked to the bathroom and fainted. I am 65 and have never fainted.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: acute flu lasting 3 days followed by 1 day with lighter symptoms.  The 3 days included acute  pain,fatigues,sleepiness,chills, body aches . On day 2 about 28 hours after taking the vaccine I walked to the bathroom and fainted. I am 65 and have never fainted.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pallor, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Round rash the size of a 50 cents coin.  Itchy and red.  The area turns white when I lift my arm.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Lymphadenopathy
Clinical narrative: Within 3-5 days of receiving first vaccine, I developed lymphadenopathy in the axillary of the arm used for injection. I then also began to notice that my (previously diagnosed, treated, and under control) eczema began to manifest. It has persisted and is only marginally under control with previous prescription steroid ointment.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Headache, Nausea
Clinical narrative: Severe deep throbbing headache that Tylenol did not work on.   Lasted 8 hrs caused nausea and eye pressure.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dry mouth, Fall, Headache
Clinical narrative: At location, she felt fine during 15min wait At 3:30-4:30 Zoom call, she looked good, but said she wasn?t feeling great & was concerned due to chills & 4days headaches after 1st dose At 8:30pm she called with chills, 3 layers of clothes & bedwarmer on... said her teeth chattered & was trying to drink warm water to heat from the inside (hydration w/o cold water; said no more coffee) At 11:00pm she texted chills were over, she was expecting aches ?but would be asleep during them?... good attitude at the time At 2:19am she called, had fallen & couldn?t get up, said she called a friend to come help her ... said she?d tried to get up, but legs were numb... said she was dizzy when she fell, total dry mouth & had reached for water, but it spilled when she knocked into things when she fell.  She wondered if she should call Fire Dept (but wasn?t making total sense).  Her friend came, tried to help, but I think she decided to call 911 for help getting her up & wants EMTs to check her out.  **She had fallen during Covid, went to ER & they gave fluids & she was ?good? for a week, but then dizzy & severe lethargy, same friend took her to ER & she was admitted (negative covid test at that point), but very large PE, thus heparin & then Eliquis (Dec 2020).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lethargy, Pain, Pulmonary embolism
Clinical narrative: At location, she felt fine during 15min wait At 3:30-4:30 Zoom call, she looked good, but said she wasn?t feeling great & was concerned due to chills & 4days headaches after 1st dose At 8:30pm she called with chills, 3 layers of clothes & bedwarmer on... said her teeth chattered & was trying to drink warm water to heat from the inside (hydration w/o cold water; said no more coffee) At 11:00pm she texted chills were over, she was expecting aches ?but would be asleep during them?... good attitude at the time At 2:19am she called, had fallen & couldn?t get up, said she called a friend to come help her ... said she?d tried to get up, but legs were numb... said she was dizzy when she fell, total dry mouth & had reached for water, but it spilled when she knocked into things when she fell.  She wondered if she should call Fire Dept (but wasn?t making total sense).  Her friend came, tried to help, but I think she decided to call 911 for help getting her up & wants EMTs to check her out.  **She had fallen during Covid, went to ER & they gave fluids & she was ?good? for a week, but then dizzy & severe lethargy, same friend took her to ER & she was admitted (negative covid test at that point), but very large PE, thus heparin & then Eliquis (Dec 2020).
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Dizziness, Electrocardiogram normal, Erythema
Clinical narrative: An hour after shot I began experiencing numbness, tingling, dizziness, and redness on the left side of my face in the cheek area. I took ibuprofen and with the advice if an online doctor I went to ER 5 dsys after the shot to have CT scan.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: An hour after shot I began experiencing numbness, tingling, dizziness, and redness on the left side of my face in the cheek area. I took ibuprofen and with the advice if an online doctor I went to ER 5 dsys after the shot to have CT scan.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: feeling really crappy; This case was reported by a other health professional via other manufacturer and described the occurrence of feeling unwell in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were provided as follows: The reporter was a pharmacy student. The patient had no medical history. The reporter contacted to inquire regarding the patient that had a bad reaction to the Shingrix vaccine and was wondering about if the patient could take COVID vaccine. The patient received Shingrix vaccine and reported feeling really crappy. The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: 2 cold sores back to back since / cold sores since first shot; This case was reported by a consumer via call center representative and described the occurrence of cold sores in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 23rd November 2020, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a month after receiving Shingles vaccine, the patient experienced cold sores. On an unknown date, the outcome of the cold sores was unknown.   It was unknown if the reporter considered the cold sores to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself.  The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient received the 1st dose of Shingles vaccine and had 2 cold sores back to back since vaccination.
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: pain at the injection site / patient is still sore / gets a sharp pain which is worse at night; This case was reported by a other health professional and described the occurrence of injection site pain in a female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number Z392F, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th October 2020, the patient received the 1st dose of FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. On 16th November 2020, 31 days after receiving FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: This case was reported by office manager. The age at vaccination was not reported. The reporter stated that the patient called the office on 16th November 2020 stating where the shot was given on the right deltoid there was pain at the injection site. There was no lump, redness, swelling or rash.  On 20th November 2020, the patient was evaluated by the doctor and stated that patient was still sore and got a sharp pain which was worse at night. This case was linked wiith US2021AMR005709 and US2020AMR252174 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR252174:same reporter US-GLAXOSMITHKLINE-US2021AMR005709:same reporter
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: she has limited ROM / cannot lay on her right side / cannot lie on that arm; she normally feels sore, but not this long / cannot lie on that arm / still in pain; This case was reported by a other health professional and described the occurrence of injected limb mobility decreased in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 33AT7, expiry date 7th November 2022) for prophylaxis.   On 6th October 2020, the patient received Boostrix. On 13th October 2020, 7 days after receiving Boostrix, the patient experienced injected limb mobility decreased and pain in arm. The patient was treated with antiinflammatory/antirheumatic products (Anti Inflammatory Drug (Nos)). On an unknown date, the outcome of the injected limb mobility decreased and pain in arm were recovering/resolving.   It was unknown if the reporter considered the injected limb mobility decreased and pain in arm to be related to Boostrix.  Additional details were provided as follows: This case was reported by office manager. The age at vaccination was not reported The patient received Boostrix on the right deltoid. The reporter stated that the patient called the office on 13th October 2020 stating that she had limited range of motion (ROM) and could not lay on her right side. She was concerned since she normally felt sore, but not this long.  The physician evaluated the patient on 13th October 2020. Pain had not improved. No redness or swelling or fever, but could not lie on that arm. The reporter spoke to the patient on 18th October 2020 and she was still in pain even after taking anti inflammatories. The patient went to get an US or the arm which was normal. The patient then had an MRI to look into further. On 27th October 2020, the patient's pain had decreased significantly and ROM had improved. MRI was not done. This case was linked with US2021AMR005709 and US2020AMR252163, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR252163:same reporter US-GLAXOSMITHKLINE-US2021AMR005709:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Pain from Shingrix; This case was reported by a consumer and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had pain.
Sex: U
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: cold sores; This case was reported by a consumer and described the occurrence of cold sores in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced cold sores. On an unknown date, the outcome of the cold sores was unknown.   It was unknown if the reporter considered the cold sores to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had cold sores since then.
Age: 67.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Rash, Vaccine positive rechallenge
Clinical narrative: rash; This case was reported by a nurse and described the occurrence of rash in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included benadryl (nos) (Benadryl) for rash.   Previously administered products included Shingrix with an associated reaction of rash (1st dose received in 27th August 2020 refer case US2020AMR215173).   On an unknown date, the patient received the 2nd dose of Shingrix and Benadryl at an unknown dose and frequency. On an unknown date, 2 days after receiving Shingrix, the patient experienced rash. The patient was treated with prednisone. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd injection of Shingrix. The physician advised to take Benadryl prior to receiving Shingrix. The patient developed rash 2 days after vaccine. The physician prescribed prednisone also. It was unknown if the reporter considered the rash to be related to Benadryl.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR215173:Same patient
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness / at the injection site/ redness grew to the size of a palm; Itching at the injection site; This case was reported by a pharmacist and described the occurrence of injection site erythema in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number FY5H2, expiry date 25th May 2022) for prophylaxis.   On 12th October 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 15th October 2020, 3 days after receiving Shingrix, the patient experienced injection site erythema and injection site itching. On 19th October 2020, the outcome of the injection site erythema was recovered/resolved. On an unknown date, the outcome of the injection site itching was recovered/resolved.   It was unknown if the reporter considered the injection site erythema and injection site itching to be related to Shingrix.  Additional details were reported as follows: The patient reported redness and itching at the injection site which presented 3 days after the vaccination of Shingrix. The rednesss grew to the size of a palm and lasted for 4 days. The itching lasted for a week. The information regarding consent to follow up was not reported but consent to follow up given.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm Soreness after receiving the first dose; This case was reported by a consumer and described the occurrence of pain in arm in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th December 2020, the patient received the 1st dose of Shingrix (intramuscular). In December 2020, less than 2 weeks after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient reported arm soreness after receiving the 1st dose of Shingrix. The reporter did not consent to follow up. This case has been linked with case US2020251651, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020251651:same reporter
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain in extremity, Paraesthesia
Clinical narrative: had a Pins and Needles sensation in his legs; Fatigue; Headache; His arm was Sore / his legs were Achy; This case was reported by a consumer and described the occurrence of pain in arm in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th December 2020, the patient received the 1st dose of Shingrix (intramuscular). On 4th December 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On 5th December 2020, the patient experienced fatigue and headache. On 14th December 2020, the patient experienced pins and needles. On an unknown date, the outcome of the pain in arm, fatigue, headache and pins and needles were recovered/resolved.   It was unknown if the reporter considered the pain in arm, fatigue, headache and pins and needles to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient's spouse. The patient received the Shingrix vaccine and expereinced arm was sore. One day after vaccination, the patient had headache and fatigue. On 11th December 2020, 7 days after the vaccination, the patient's legs were achy. 10 days after the vaccination, the patient had pins and needles sensation in his legs. The all symptoms had resolved, till the time of report. The patient did not consent to follow up. This case had been linked with the case ID US2020251650, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020251650:same reporter
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: arm started to swell up / approximately 1/2 inch by 2 inches / Now / is about 4 inches by 4 inches/ swollen like a baseball; circular area with 2 red dots; This case was reported by a consumer and described the occurrence of extensive swelling of vaccinated limb in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th January 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In January 2021, less than a week after receiving Shingrix, the patient experienced erythema. On 19th January 2021, the patient experienced extensive swelling of vaccinated limb. The patient was treated with paracetamol (Tylenol) and non-drug therapy (Warm Compress). On an unknown date, the outcome of the extensive swelling of vaccinated limb and erythema were not recovered/not resolved.   The reporter considered the extensive swelling of vaccinated limb and erythema to be related to Shingrix.  Additional details were reported as follows: The patient received the dose, 2 days ago from date of reporting.  The patient stated that a few hours after receiving the injection, her arm started to swell up.  She reported that the area started off approximately half inch by 2 inches and that overnight the swelling got worse.  Then the area was about 4 inches by 4 inches and was swollen like a baseball (symptoms were not recovered).  It was a circular area with 2 red dots.  The reporter asked how long this could be lasted and information was provided per content frequently asked questions and copy of the PI was offered. The reporter was advised to follow up with her HCP.  She stated that she had been treating it with Tylenol and warm compresses.  The reporter did not consent to follow-up and declined to provide HCP information.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: It leaked and she is concerned she missed some of the dose; A spontaneous report was received from a nurse concerning a 36-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and it leaked and she is concerned that she missed some of the dose.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     On 05 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly for prophylaxis of COVID-19 infection, but there was an issue with the needle and syringe. It leaked and she is concerned that she missed some of the dose.  Treatment information was not provided.   The outcome of the even was considered resolved on 05 Feb 2021.; Reporter's Comments: Based on current information the causality of this event was assessed as not applicable.