chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Vomiting
Clinical narrative: Estimated delivery date: 05/15/2021  On 12/21 I felt a lot of fatigue and a headache and then the next time I had symptoms was 12/28 I had nausea, vomiting and diarrhea.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on face, neck, back and legs
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Paraesthesia oral
Clinical narrative: Tingling tongue, progressive chest redness. ED transfer with IV solumedrol & Benadryl administered
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Electrocardiogram normal, Myocardial necrosis marker normal
Clinical narrative: Approximately 15 minutes after IM injection, patient developed chest tightness.  Patient was taken to the Emergency Department for treatment.  Was given sublingual nitroglycerin  and subsequently admitted to the hospital for observation.  Patient discharged home the following morning in good condition.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Headache, Pain in extremity
Clinical narrative: Significant fatigue, headaches, GI upset, arm soreness that lasted 3 days. Fatigue continues to last.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: moderate headache started 24 hours later, lasted 4 hours.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain, Product administered at inappropriate site
Clinical narrative: PT states that the pharmacist went to high on her shoulder when giving the vaccine. After a few hours she couldn't move her arm, she still cant lift or rotate her shoulder. She is in intense pain and believes it is due to vaccination given
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Migraine, Nausea
Clinical narrative: 67-year-old female employee (pediatric surgery office practice nurse) with history of migraine headache, no significant episodes after menopause, who received a 1st COVID vaccine dose 12/22/2020 here with a 3rd episode of migraine headache, nausea, and dizziness since vaccination.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Headache
Clinical narrative: Elevated BP, headache, dizzyness
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever up to 102, body aches, chills, arm pain
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Respiratory tract congestion
Clinical narrative: Contracted COVID, loss of taste or smell, cough, congestion
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Contracted COVID, loss of taste or smell, cough, congestion
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Heart rate increased, Hot flush, Injection site pain
Clinical narrative: Nausea, "felt hot", light headed, dizzy, face tingling, elevated heart rate, rash to arm of injection site, soreness to injection site. Stayed for observation. Currently having on and off "hot flashes", and slightly light headed. Other symptoms have resolved.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Nausea, Paraesthesia
Clinical narrative: Nausea, "felt hot", light headed, dizzy, face tingling, elevated heart rate, rash to arm of injection site, soreness to injection site. Stayed for observation. Currently having on and off "hot flashes", and slightly light headed. Other symptoms have resolved.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Diarrhoea, Hallucination, Pain in extremity, Pyrexia
Clinical narrative: Confused, fevers, hallucinations, restlessness, diarrhea, lower extremity pain
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Restlessness
Clinical narrative: Confused, fevers, hallucinations, restlessness, diarrhea, lower extremity pain
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Dyspnoea, Head discomfort, Headache, Hypotonia
Clinical narrative: After patient received his vaccine shot, he was directed to the observation area.  While sitting in the observation area; the patient was observed going limp and loss of consciousness.  The patient was assisted to the floor on top of the mat.  Facility medical personal was able to get the patient to respond after several sternal chest rubs.  EMS was activated and responded to the scene. The patient was released at the scene by EMS and was observed by facility medical personnel until he was deem stabled.  The patient described that he felt his breathing began to slow down until it was difficult to breathe.  He felt shortness of breath and then blacked out.  When he came to he describes that he had difficulty breathing while lying down and asked to be seated in an upright position.  Once in the seated position he was able to breathe better but had a pressure headache but it eventually went away after several minutes.  He was told by facility staff that his BP went up to 200/111 but then went back down to the 120's.   The patient stated he has been required to get several vaccines thus he had no problem getting vaccines (shots).  He wanted to learn more about the COVID vaccines and the differences between Pfizer and Moderna vaccines.  With COVID-19 being a new pandemic, it is a threat that is unknown, the patient believes that could cause him to have a higher level of anxiety.   The patient stated he only had coffee and a biscuit in the morning.   The patient believes the anxiety and possibility of not having food in his stomach before the vaccine may have caused him to lose conciseness.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Respiratory rate decreased
Clinical narrative: After patient received his vaccine shot, he was directed to the observation area.  While sitting in the observation area; the patient was observed going limp and loss of consciousness.  The patient was assisted to the floor on top of the mat.  Facility medical personal was able to get the patient to respond after several sternal chest rubs.  EMS was activated and responded to the scene. The patient was released at the scene by EMS and was observed by facility medical personnel until he was deem stabled.  The patient described that he felt his breathing began to slow down until it was difficult to breathe.  He felt shortness of breath and then blacked out.  When he came to he describes that he had difficulty breathing while lying down and asked to be seated in an upright position.  Once in the seated position he was able to breathe better but had a pressure headache but it eventually went away after several minutes.  He was told by facility staff that his BP went up to 200/111 but then went back down to the 120's.   The patient stated he has been required to get several vaccines thus he had no problem getting vaccines (shots).  He wanted to learn more about the COVID vaccines and the differences between Pfizer and Moderna vaccines.  With COVID-19 being a new pandemic, it is a threat that is unknown, the patient believes that could cause him to have a higher level of anxiety.   The patient stated he only had coffee and a biscuit in the morning.   The patient believes the anxiety and possibility of not having food in his stomach before the vaccine may have caused him to lose conciseness.
Age: 67.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: By end of first day arm area around shot had become red and sore.  By the next day my arm from my shoulder to my elbow was red, warm, very swollen and tender.   My are was so swollen that the sleeves of my shirt were tight.  Two days after the shot when the symptoms continued to worsen I scheduled an appointment at the clinic.   The healthcare provider prescribed a 15 day course of prednisone 20 mg tablets.   It took several days for the swelling in my arm to decrease.    This was the second Pneumococcal vaccine that  I have received.  On July 11, 2019 I was given the PCV13 vaccination.  I did not have any reaction to that vaccine.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Oral mucosal blistering, Paraesthesia, Pruritus
Clinical narrative: 12/28/2020 Approx 10 min post vaccine pt reported feeling periorbital tingling.  She also felt an itching sensation on right arm (opposite injection site).  No rash noted.  She received 50 mg  iv Benadryl and had extended observation.  No worsening symptoms, noted at the time. She was offered ED follow-up but declined.  12/29/2020 patient noted no worsening symptoms the evening of the vaccine.  However, morning after she noted blisters in mouth.  She is following up with her primary care doctor.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: about 12 hours later w/ PAIN ON RT ARM , SWELLING OF left THIGH WITH PAIN
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Lip pruritus, Lip swelling, Swollen tongue, Throat irritation
Clinical narrative: Cold feeling to throat and mouth 30 minutes after administration lasting 15 minutes. Followed by: Tongue swelling Lip swelling with hives Itchy throat and lips lasted approximately 4 hours.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Cold feeling to throat and mouth 30 minutes after administration lasting 15 minutes. Followed by: Tongue swelling Lip swelling with hives Itchy throat and lips lasted approximately 4 hours.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: 101.5 Fever, Nausea, joint pain, muscle aches all over body, severe fatigue, headache, severe injection site soreness
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: 101.5 Fever, Nausea, joint pain, muscle aches all over body, severe fatigue, headache, severe injection site soreness
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Loss of consciousness, Nausea
Clinical narrative: HAD CHILLS, FELL ASLEEP GOT UP TO BRUSH TEETH HAD EXTREME NAUSEA, PASSED OUT CAME TO ON FLOOR IN COLD SWEAT.  FEEL FINE TODAY
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle ache
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash papular, Rash pruritic
Clinical narrative: about 3-5 days post vaccine the patient developed an itchy papular rash along his body (chest, back, neck, arms and legs). He has taken hot showers which has not helped, but he has taken Benadryl at night the last two nights which have helped with the itching.  He was placed on prednisone today and recommended to continue with antihistamines.  He has NOT had an anaphylactic or angioedema reaction, now or in the past.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Area around injection site red, heated, and itchy - did not occur until today 12/30/2020.  Measures 1.5/1.5 inches
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Decreased appetite, Diarrhoea
Clinical narrative: Patient started having decreased appetite, and diarrhea starting 2 days after patient receiving vaccinations.  Diarrhea described as "mushy" and having mucous in it.  Patient not wanting to eat as he normally would.  Patient didn't have fever or any other symptoms.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Myalgia, Pyrexia
Clinical narrative: Body muscle and joint aches, chills, fever, no appetite x 24 hours
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on right arm and heart rate > 100.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Exercise tolerance decreased, Fatigue, Pain in extremity
Clinical narrative: The usual pain on 12/19 exp soreness of arm, fatigue and  intermittent need to take a breath. Then I went running as usual I wasn't able. On 12/20 I tried again to go running very slow, breathless. When I came home took shower I noticed a  rash above abdomen dint itch. I  noticed that evening felt breathless .When I came in on 12/21 I contacted my team about the rash. I developed a cough every couple hrs.I went to see PCP on 12/22 took Covid test results negative, still exp with cough, rash symptoms expressed concerns of being possible asymptomatic. The cough wasn't as frequent and the rash went away on 12/23.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test negative
Clinical narrative: The usual pain on 12/19 exp soreness of arm, fatigue and  intermittent need to take a breath. Then I went running as usual I wasn't able. On 12/20 I tried again to go running very slow, breathless. When I came home took shower I noticed a  rash above abdomen dint itch. I  noticed that evening felt breathless .When I came in on 12/21 I contacted my team about the rash. I developed a cough every couple hrs.I went to see PCP on 12/22 took Covid test results negative, still exp with cough, rash symptoms expressed concerns of being possible asymptomatic. The cough wasn't as frequent and the rash went away on 12/23.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Itching all over, Arms, legs, feet and hands with no Rash. Swelling of Hand and Feet. Started 12/29 and progressively worsened over the evening.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Feeding disorder, Headache, Nausea, Respiratory tract congestion
Clinical narrative: Patient became nauseated on 12/24/2020.  She was unable to eat breakfast.  She felt better when lying down.  She became congested on 12/26/2020.  She also had a headache behind the eyes. She took acetaminophen and pseudoephedrine for 3 days (duration of headache/congestion).  She returned to work on 12/29/2020 and took Tylenol only on this day.  No medications on 12/30/2020 and all symptoms were resolved on this day.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dyspnoea, Heart rate increased, Palpitations
Clinical narrative: feeling anxious, heart palpitations, heart rate was 200. Started to level out but stayed elevated. Short of breath
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Fatigue, Rash, Somnolence
Clinical narrative: I came home after my 15 min wait time. I got in the shower,  I felt my face burning (no  water or soap on my face). When I got out of the shower, and I looked in the mirror and I saw my face was red and bumps were on my entire cheeks and started to go down to my chin, and nose,  all the way to my neck, under my chin. It felt like my face was on fire. I then called Urgent Care. I sent pictures to her, she advised I took Benadryl. I took another picture and it was getting worse. I  was completely exhausted and was very sleepy. I took 50mg of Benadryl , and Urgent Care instructed me to take 10mg of decatron, with the Benadryl and when I woke up 4 hours later,  I looked and my face was red, but had significantly improved. I had some bumps still but the redness had subsided.  When I woke up about 4 the last time,  there was just bumps. The next two days later every thing was completely resolved
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Palpitations, Paraesthesia, Presyncope
Clinical narrative: after 15 minutes patient stated she began to feel like her heart was racing and she went to stand up and stated she almost fainted. She stated she was experiencing tingling in hands and feeling of heaviness all over. BP 133/92 HR 94 O2saturation 100 resp 20. Patient placed on stretcher,no altered loc, patient alert oriented x 3 skin warm and dry,coloring remained unchanged. Patient given cheese and crackers,water and soda. Patient stated she had eaten that morning. patient kept and monitored x 1 hour. Bp retaken multiple times. Bp at D/C was 111/74 hr 86 resp 18. this was at 1330p. patient stated no complaints. Instructed to follow up with her PCP and was escorted to cafeteria to get lunch. Reported incident to Supervisor of hospital  and also  Health Dept.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Nasopharyngitis, Respiratory tract congestion
Clinical narrative: diarrhea, headache, cold like symptoms, congested
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Hyperhidrosis, Myalgia
Clinical narrative: Began with headache about 9am on 12/24. By 4pm symptoms included chills, sweating, joint pain, muscle pain. From 4pm to 8pm on 12/24 was the worst period of time. Fever never went above 99. Treated with OTC medicines (Tylenol, Motrin) and rest until symptoms subsided on 12/26 at about 5pm.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Began with headache about 9am on 12/24. By 4pm symptoms included chills, sweating, joint pain, muscle pain. From 4pm to 8pm on 12/24 was the worst period of time. Fever never went above 99. Treated with OTC medicines (Tylenol, Motrin) and rest until symptoms subsided on 12/26 at about 5pm.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Blood electrolytes normal, Blood potassium decreased, Diarrhoea, Fatigue, Gastroenteritis
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA: One day after receving vaccine patient presented to the emergency department reporting fever (up to 100 degrees Fahrenheit), nausea, vomiting (resulting in sore throat),  diarrhea, fatigue, and body aches that started one day after after vaccine administration. Patient took acetaminophen prior to coming to the emergency department. Vital signs were blood pressure 131/85 mmHg, pulse 93 beats per minute, respiratory rate 16 breaths per minute, temperature 35.9 degrees Celcius, and oxygen saturation 95% on room air. On exam patient was awake, alert, and oriented times three, speaking in full sentances, and without repiratory distress or chest pain. The patient had no known COVID-19 positive contacts. Intravenous fluids and one dose of ondansetron were administered with  significant symptom improvement and patient tolerated oral fluids.  Patient was discharged from the emergency department to home ambulatory in stable condition. Provider stated most likely etiology of symptoms was gastroenteritis.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Nausea, Oropharyngeal pain
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA: One day after receving vaccine patient presented to the emergency department reporting fever (up to 100 degrees Fahrenheit), nausea, vomiting (resulting in sore throat),  diarrhea, fatigue, and body aches that started one day after after vaccine administration. Patient took acetaminophen prior to coming to the emergency department. Vital signs were blood pressure 131/85 mmHg, pulse 93 beats per minute, respiratory rate 16 breaths per minute, temperature 35.9 degrees Celcius, and oxygen saturation 95% on room air. On exam patient was awake, alert, and oriented times three, speaking in full sentances, and without repiratory distress or chest pain. The patient had no known COVID-19 positive contacts. Intravenous fluids and one dose of ondansetron were administered with  significant symptom improvement and patient tolerated oral fluids.  Patient was discharged from the emergency department to home ambulatory in stable condition. Provider stated most likely etiology of symptoms was gastroenteritis.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Polymerase chain reaction, Pyrexia, Respiratory syncytial virus test negative, SARS-CoV-2 test negative
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA: One day after receving vaccine patient presented to the emergency department reporting fever (up to 100 degrees Fahrenheit), nausea, vomiting (resulting in sore throat),  diarrhea, fatigue, and body aches that started one day after after vaccine administration. Patient took acetaminophen prior to coming to the emergency department. Vital signs were blood pressure 131/85 mmHg, pulse 93 beats per minute, respiratory rate 16 breaths per minute, temperature 35.9 degrees Celcius, and oxygen saturation 95% on room air. On exam patient was awake, alert, and oriented times three, speaking in full sentances, and without repiratory distress or chest pain. The patient had no known COVID-19 positive contacts. Intravenous fluids and one dose of ondansetron were administered with  significant symptom improvement and patient tolerated oral fluids.  Patient was discharged from the emergency department to home ambulatory in stable condition. Provider stated most likely etiology of symptoms was gastroenteritis.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA: One day after receving vaccine patient presented to the emergency department reporting fever (up to 100 degrees Fahrenheit), nausea, vomiting (resulting in sore throat),  diarrhea, fatigue, and body aches that started one day after after vaccine administration. Patient took acetaminophen prior to coming to the emergency department. Vital signs were blood pressure 131/85 mmHg, pulse 93 beats per minute, respiratory rate 16 breaths per minute, temperature 35.9 degrees Celcius, and oxygen saturation 95% on room air. On exam patient was awake, alert, and oriented times three, speaking in full sentances, and without repiratory distress or chest pain. The patient had no known COVID-19 positive contacts. Intravenous fluids and one dose of ondansetron were administered with  significant symptom improvement and patient tolerated oral fluids.  Patient was discharged from the emergency department to home ambulatory in stable condition. Provider stated most likely etiology of symptoms was gastroenteritis.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash macular
Clinical narrative: within 15 minutes of receiving vaccine patient complained of feeling "itchy all over".  Patient was noted to have blotchiness on bilateral temples Patient was administered Benadryl 25mg PO x1 at 1038 at Direction of NP Patient remained seated under observation under NP for an additional 15 minutes Patient stated feeling much better, less itchy and was released at 1055
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Heart rate increased, Paraesthesia, Skin tightness, Swelling
Clinical narrative: anaphylaxis history - hands felt tingly and tight.  "Swelling"  Benadryl given iniitally bp and pulse up.  last vitals are 130/89; 71; 99% and 16 Symptoms improved
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomited x1 approximately 30 -45 minutes after being vaccinated. Immediate recovery
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site haemorrhage, Injection site induration, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Initial edema  at injection site size of quarter/ecchymosis. At day #7 3x5 cm Induration, warmth and tenderness, ecchymosis fading.  Saw doctor, prescribed Keflex for potential cellulitis.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Night sweats
Clinical narrative: Fatigue, night sweats. Symptoms have resolved. Took Ibuprofen at time of symptoms.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pharyngeal swelling, Tachycardia
Clinical narrative: Moderna COVID-19 Vaccine EUA 15-20 minutes after IM injection, pt developed subjective swelling in the back of throat, "heart racing", tachycardia On physical exam, clinically well, no airway compromise, no visible posterior oropharyngeal swelling, no NV, no rash/hives, HR 120s, no hypotension Treated with PO Benadryl, symptoms resolved, HR resolved Observed for 1 hour with no symptom recurrence
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Laboratory test, Pallor, Urine analysis
Clinical narrative: Co-worker  felt faint and was pale, BP was 93/58. Co-worker reported she has POTS (posterior orthostatic tachycardia) and she reported that she did not take her medication that day. Patient was taken to the emergency room.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Asthenopia, Cardiac monitoring, Dry throat, Dysphagia
Clinical narrative: Was being monitored x 30 minutes after vaccination. Approximately 15 minutes after administration, eyes began to get heavy and swell. "My heart was racing." Wheelchair to ED. They could not get IV access. Throat was dry. They got an IV and gave Benadryl. "My throat starting swelling and I could not swallow." "I was panting and my heart was beating out of my chest." The ED staff administered epinephrine pen via IM injection. Anaphylaxis resolved and she was monitored x 4 hours in ED. Sent home on prednisone and fomatidine.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Palpitations, Pharyngeal swelling, Respiration abnormal
Clinical narrative: Was being monitored x 30 minutes after vaccination. Approximately 15 minutes after administration, eyes began to get heavy and swell. "My heart was racing." Wheelchair to ED. They could not get IV access. Throat was dry. They got an IV and gave Benadryl. "My throat starting swelling and I could not swallow." "I was panting and my heart was beating out of my chest." The ED staff administered epinephrine pen via IM injection. Anaphylaxis resolved and she was monitored x 4 hours in ED. Sent home on prednisone and fomatidine.
Age: 78.0
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Skin warm
Clinical narrative: Red, swollen, hot. Still red on Dec. 30.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE; improperly stored administered vaccines; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 20-NOV-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX), dose: 0.5 milliliter, lot# S003446, expiry date: 04-FEB-2021 (dose number, route of administration, anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of -10.8 degrees Celsius for 1 hour 30 minutes. There were previous excursions related: -12.3 degrees Celsius for 1 hour and -10.3 degrees Celsius for 10 hours and 30 minutes. Data logger was involved. No adverse events were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2012USA003543:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no additional AE; improperly stored administered vaccines; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 20-NOV-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX), dose: 0.5 milliliter, lot# S035126, expiry date: 04-NOV-2021 (dose number, route of administration, anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of -10.8 degrees Celsius for 1 hour 30 minutes. There were previous excursions related: -12.3 degrees Celsius for 1 hour and -10.3 degrees Celsius for 10 hours and 30 minutes. Data logger was involved. No adverse events were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2012USA003543:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no additional AE; improperly stored administered vaccines; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 20-NOV-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX), dose: 0.5 milliliter, lot# S003446, expiry date: 04-FEB-2021 (dose number, route of administration, anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of -10.8 degrees Celsius for 1 hour 30 minutes. There were previous excursions related: -12.3 degrees Celsius for 1 hour and -10.3 degrees Celsius for 10 hours and 30 minutes. Data logger was involved. No adverse events were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2012USA003543:
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever after shingles shot; This case was reported by a consumer and described the occurrence of fever in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingles vaccine.  Additional details were provided as follows: The age at the vaccination was not reported. The age group was not reported but was selected as an adult  per the vaccine indication. The patient asked how long would run a fever after shingles shot.
Sex: U
Vaccine: VARZOS
Symptoms: Cough, Headache, Myalgia, Pyrexia
Clinical narrative: Muscle ache; Headache; Fever; Cough; This case was reported by a consumer via interactive digital media and described the occurrence of muscle 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 muscle pain, headache, fever and cough. On an unknown date, the outcome of the muscle pain, headache, fever and cough were recovered/resolved.   It was unknown if the reporter considered the muscle pain, headache, fever and cough to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as per the vaccine indication. The age at vaccination was not reported. The patient have had muscle aches and headache, fever and cough for 6 days since taking the Shingrix vaccine was this normal.
Sex: U
Vaccine: VARZOS
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Arm being hot; Arm being hot and swollen; This case was reported by a consumer and described the occurrence of skin warm in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced skin warm and swelling arm. On an unknown date, the outcome of the skin warm and swelling arm were unknown.   It was unknown if the reporter considered the skin warm and swelling arm to be related to Shingles vaccine.  Additional details were provided as follows: The age group was not reported but was selected as per the vaccine indication. The age at vaccination was not reported. The patient asked what could do about his/her arm being hot and swollen after the shingles shot.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Arm is still sore; Arm is still sore and red; Arm is still sore and red and swollen; This case was reported by a consumer and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In November 2020, the patient received Shingles vaccine. In November 2020, less than a week after receiving Shingles vaccine, the patient experienced pain in arm, erythema of extremities and swelling arm. On an unknown date, the outcome of the pain in arm, erythema of extremities and swelling arm were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, erythema of extremities and swelling arm to be related to Shingles vaccine.  Additional details were provided as follows: The age group was not reported but was selected as per the vaccine indication. The age at vaccination was not reported. The patient had shingle shot a week ago at doctor's office. The patient experienced arm was still sore and red and swollen.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: I feel awful; can hardly get out of bed; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th November 2020, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced feeling bad and bedridden. On an unknown date, the outcome of the feeling bad and bedridden were not recovered/not resolved.   It was unknown if the reporter considered the feeling bad and bedridden to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as per the vaccine indication. The age at vaccination not reported. The patient feel awful and can hardly get out of bed.  The patient have all of the side effects. The patient asked how long do the side effects of the Shingrix vaccine last.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Injection site pain, Product preparation issue
Clinical narrative: Arm soreness at injection site; Received the adjuvant portion only; Received the adjuvant portion only without the lyophilized antigen component; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number 9LH3Y, expiry date 7th February 2022) and (batch number TT2JF, expiry date 28th October 2022) for prophylaxis.   On 29th October 2020, the patient received the 1st dose of Shingrix. On 29th October 2020, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The reporter asked for some guidance on a Shingrix first dose given to a patient who received only the adjuvant portion (without the lyophilized antigen component), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up by email.   Follow up information received from pharmacist on 1st December 2020: The patient's demographics were updated. The batch number and expiry details were updated. The patient received Shingrix via intramuscular. The patient experienced injection site pain.  It was reported that error occurred durring the administration. This was 1st shingrix shot to be administered and rporter failed to mix the adjuvant in to the antigen portion. The patient just received adjuvant, contributiing factor was that dose was given durring flu season where several flu shots had just been drawn from vial and injected. The outcome of injection site pain was unknown.  The reporter considered the injection site pain to be possibly related to Shingrix. The VAERS details were updated.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pain in extremity
Clinical narrative: lots of pain; shivers, chills; the pain was "the normal pain in the arm."; This case was reported by a consumer via call center representative and described the occurrence of pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included herpes virus infection (getting herpes once a year when going out into the sun).   On 10th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 11th October 2020, 1 days after receiving Shingrix, the patient experienced pain, shivers and pain in arm. Shingrix was interrupted. On 13th October 2020, the outcome of the pain, shivers and pain in arm were recovered/resolved.   It was unknown if the reporter considered the pain, shivers and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient reported experiencing shivers, chills, and lots of pain after getting the 1st dose of the Shingrix vaccine.  The patient stated that the pain was the normal pain in the arm. The patient reported the vaccine in the left arm at She also stated these occurred the next day and only lasted for about two days.  The health care professional informed her to not get the 2nd dose.  The patient also reported getting herpes once a year when going out into the sun. The reporter consented to follow up.
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: Drawing up 10th dose from vial, dose 0.2ml short.  Vaccine wasted by pharmacy, did not use.  Opened new vial for patient.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Cough, Headache, Oropharyngeal pain
Clinical narrative: 7 days after administration of the Pfizer COVID vaccine, pt came to the Medical Center ED complaining of cough, sore throat, headache, chills, body aches, and fever. She stated that she also had abdominal pain earlier in the day but that had resolved. She denied shortness of breath, nausea, vomiting, or diarrhea. Lung sounds were clear on exam. O2 97%, HR 115, RR 18, BP 127/69, temp 99.4. Pt had a NAAT test for COVID which returned positive.  She was discharged to home where her symptoms are still continuing at this time.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: 7 days after administration of the Pfizer COVID vaccine, pt came to the Medical Center ED complaining of cough, sore throat, headache, chills, body aches, and fever. She stated that she also had abdominal pain earlier in the day but that had resolved. She denied shortness of breath, nausea, vomiting, or diarrhea. Lung sounds were clear on exam. O2 97%, HR 115, RR 18, BP 127/69, temp 99.4. Pt had a NAAT test for COVID which returned positive.  She was discharged to home where her symptoms are still continuing at this time.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Fatigue the day after, Headache ever sense vaccination
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed level of consciousness, Fall, Gait disturbance, Head injury, Headache
Clinical narrative: Mild soreness at the injection site started within within 3 hours of the injection. However, on 12/29/20 at 3:00 AM, I woke up with moderate pain  (5 out of 10 pain level).  I got up  and  within 1-2 minutes I felt nauseous, a hot flush raised up my neck, my vision went black and I collapsed. I did not fully lost consciousness. I was on the bathroom and fell onto the bathtub hitting  my right tight and right forehead strongly against the edges of the bathtub.  As of today, 30 hours after the fall, my right leg and forehead continue to be moderately soreness, with limiting my ability to walk up and down stairs.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Injection site pain, Limb injury, Nausea, Pain
Clinical narrative: Mild soreness at the injection site started within within 3 hours of the injection. However, on 12/29/20 at 3:00 AM, I woke up with moderate pain  (5 out of 10 pain level).  I got up  and  within 1-2 minutes I felt nauseous, a hot flush raised up my neck, my vision went black and I collapsed. I did not fully lost consciousness. I was on the bathroom and fell onto the bathtub hitting  my right tight and right forehead strongly against the edges of the bathtub.  As of today, 30 hours after the fall, my right leg and forehead continue to be moderately soreness, with limiting my ability to walk up and down stairs.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Syncope, Visual impairment
Clinical narrative: Mild soreness at the injection site started within within 3 hours of the injection. However, on 12/29/20 at 3:00 AM, I woke up with moderate pain  (5 out of 10 pain level).  I got up  and  within 1-2 minutes I felt nauseous, a hot flush raised up my neck, my vision went black and I collapsed. I did not fully lost consciousness. I was on the bathroom and fell onto the bathtub hitting  my right tight and right forehead strongly against the edges of the bathtub.  As of today, 30 hours after the fall, my right leg and forehead continue to be moderately soreness, with limiting my ability to walk up and down stairs.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Pain, Vomiting
Clinical narrative: Massive headache within 1 hour of injection that lasted all evening.  Dizziness, Aches, Nausea that led to vomiting.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Toothache
Clinical narrative: Mild nerve pain in back teeth on left side (top and bottom). No visible signs of cavities.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: MILD RED RASH OVER THE CHEST WITH MILD ITCHING
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Vaccination site pain
Clinical narrative: The vaccinating nurse did not administer IM in the deltoid, it was injected at an angle (that was not 90 degrees) into the acromion/bursa space. There were no immediate reactions to report at the time of vaccination other than shoulder pain/tenderness near the vaccination site.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Myalgia, Pain of skin, Skin burning sensation
Clinical narrative: 12/24-12/26: Moderate left sided muscle and joint pain. Injection sight pain/soreness 12/25: Moderate muscle and joint pain effecting both right and left side of body. Injection sight pain/soreness 12/25-12/26: Moderate hypersensitivity of skin on left side of body / painful to the touch / burning sensation. Injection sight pain/soreness 12/26 Evening: Symptoms mostly resolved  12/27-12/30: Mild muscle aches/soreness left sided
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dizziness, Dyspnoea, Flushing
Clinical narrative: Light head, nausea, "hot flash", flushes, chills, numb tongue, chest pain, shortness of breath, headache, hematoma to injection site, difficulty extending left arm. Took Benadryl and is currently in the emergency department.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hot flush, Hypoaesthesia oral, Injected limb mobility decreased, Injection site haematoma
Clinical narrative: Light head, nausea, "hot flash", flushes, chills, numb tongue, chest pain, shortness of breath, headache, hematoma to injection site, difficulty extending left arm. Took Benadryl and is currently in the emergency department.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Light head, nausea, "hot flash", flushes, chills, numb tongue, chest pain, shortness of breath, headache, hematoma to injection site, difficulty extending left arm. Took Benadryl and is currently in the emergency department.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Tremor, Vomiting
Clinical narrative: Dizziness, headache, nausea and vomiting, shaking.  Tylenol and Benadryl
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia
Clinical narrative: About 10 minutes after vaccination employee complained of numbness in left arm. Then felt dizzy and as if she was about to pass out. BP 180/112. Numbness in legs.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain
Clinical narrative: Headache, body pain, chill, nausea
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes under armpit
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Insomnia, Pain, Pain in extremity
Clinical narrative: Body aches, fever of 102, arm soreness, lack of sleep (all night), chills, fatigue, fever lasted about 9 hours.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Body aches, fever of 102, arm soreness, lack of sleep (all night), chills, fatigue, fever lasted about 9 hours.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Patient contacted us to  report having muscle spasms in her left thigh post vaccination. Vaccinated in left arm. She states that she never has had these spasms in past and these developed 24 hours after receiving vaccination so did not know if related or not. Has not injured leg in question. No other symptoms noted. Still having spasms at time reported today.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Extremity contracture, Joint contracture, Limb discomfort, Muscle spasticity, Muscle tightness
Clinical narrative: Monday-My left lower arm and hand were getting weak and tingly and hand kept curling in. Then my right arm and hand started feeling tingly and weak and that hand kept curling in. Then there was some tightness/tensing up in my neck. It became hard to talk-not swelling of throat but tight jawish area.  Today-Wednesday-right arm is extremely weak and heavy. Right hand fingers keep curling in and spazing out Going to doctor today. Left arm is still a little weak, hand keeps curling
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Paraesthesia, Speech disorder
Clinical narrative: Monday-My left lower arm and hand were getting weak and tingly and hand kept curling in. Then my right arm and hand started feeling tingly and weak and that hand kept curling in. Then there was some tightness/tensing up in my neck. It became hard to talk-not swelling of throat but tight jawish area.  Today-Wednesday-right arm is extremely weak and heavy. Right hand fingers keep curling in and spazing out Going to doctor today. Left arm is still a little weak, hand keeps curling
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: patient reports weakness in left arm and shoulder which he noticed upon waking the next morning. reports soreness that has not resolved, strengthed estimated to be at apporoximately 75-80% in his only functioning arm.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Erythema, Fatigue, Feeling cold
Clinical narrative: the following day after the vaccine I woke up with severe upper leg muscle pain, joint pain thru my whole body, severe headache with nausea, fatigue, my cheeks appeared wind burnt, I had extreme chills with shaking due to feeling so cold and felt feverish, no fever registered on a thermometer though. I had all these symptoms  for  approx. 24 hours with feelings of severe flu.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Myalgia, Nausea, Pyrexia
Clinical narrative: the following day after the vaccine I woke up with severe upper leg muscle pain, joint pain thru my whole body, severe headache with nausea, fatigue, my cheeks appeared wind burnt, I had extreme chills with shaking due to feeling so cold and felt feverish, no fever registered on a thermometer though. I had all these symptoms  for  approx. 24 hours with feelings of severe flu.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: the following day after the vaccine I woke up with severe upper leg muscle pain, joint pain thru my whole body, severe headache with nausea, fatigue, my cheeks appeared wind burnt, I had extreme chills with shaking due to feeling so cold and felt feverish, no fever registered on a thermometer though. I had all these symptoms  for  approx. 24 hours with feelings of severe flu.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Headache, Muscle spasms
Clinical narrative: Slight headache and intermittent dizziness starting about 1 hour afterwards. By 8 hours afterwards: fever of 100.1, with chills, aches, and joint pain. Woke up at 4:15 AM with a fever of 103.4, now 24 hours later fever is 101.9. Acetaminophen takes the edge off the fever. The only unusual/unlisted symptom I'm having is muscle cramping.  I was warned that people who had COVID (I had it in March 2020) may experience side effects, so I'm not particularly concerned.