chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 102 fever that wouldn't break until about 10 hrs later, severe nausea and headaches, dizziness, extreme body pain
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Hypotension, Nausea, Pallor
Clinical narrative: Patient became dizzy, lightheaded, pale, diaphoretic and hypotensive approx. 5 minutes after receiving vaccine. Also c/o nausea without vomiting.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Hot flush
Clinical narrative: Heat flash Elevated BP
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dysgeusia, Headache, Malaise, Nausea
Clinical narrative: At 8:50 AM she developed nausea, diffuse headache, malaise, tingling of her hands, elevated blood pressure and metal taste in mouth.  She denied any trouble breathing. No swallowing difficulty, swelling of the tongue or lips observed.  Subject stated she did not feel safe driving and was brought to ED by EMS.  She has a history of fibromuscular dysplasia and is on aspirin and Plavix.  Emergency Department ASSESSMENT and PLAN This is a 58 y.o. female who presents with vaccination side effects.  She is well-appearing on exam.  There is no evidence of airway swelling or anaphylaxis.  Will observe. 11:34 AM Has been observed for 2 hours and her symptoms have not worsened.  She did take her own dose of Tylenol for headache.  She is comfortable returning home.  She does have the Moderna fact sheet and we discussed signs and symptoms of when to return.  She is comfortable with plan.  All questions were answered."
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: At 8:50 AM she developed nausea, diffuse headache, malaise, tingling of her hands, elevated blood pressure and metal taste in mouth.  She denied any trouble breathing. No swallowing difficulty, swelling of the tongue or lips observed.  Subject stated she did not feel safe driving and was brought to ED by EMS.  She has a history of fibromuscular dysplasia and is on aspirin and Plavix.  Emergency Department ASSESSMENT and PLAN This is a 58 y.o. female who presents with vaccination side effects.  She is well-appearing on exam.  There is no evidence of airway swelling or anaphylaxis.  Will observe. 11:34 AM Has been observed for 2 hours and her symptoms have not worsened.  She did take her own dose of Tylenol for headache.  She is comfortable returning home.  She does have the Moderna fact sheet and we discussed signs and symptoms of when to return.  She is comfortable with plan.  All questions were answered."
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Endotracheal intubation, Erythema, Pruritus, Rash
Clinical narrative: Itching, redness, rash, difficulty breathing
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: I received COVID vaccine on December 23rd and had tongue swelling one hour later. I took Tylenol and benedryl and swelling went away
Age: 56.0
Sex: U
Vaccine: FLUC4, PNC13, VARZOS
Symptoms: Herpes zoster
Clinical narrative: patient developed shingles on eyelid. diagnosed by optometrist
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Employee became dizzy at time of check out from observation area. Employee was taken to ED for evaluation.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Nasal congestion, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: fever 102.7 in the evening of 12/28, in the morning 99.6 with stuffy nose/chills, soreness at injection site, COVID + 12/14
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Flushing, Heart rate increased, Throat irritation, Throat tightness
Clinical narrative: Employee received the  Pfizer covid vaccine @ 0752. @ 0800 employee  began to feel flushed, SOB, increased HR. Patient also had some throat tightness and itchiness. BP 147/95. O2 100% HR 149 @ 0755. Symptoms worsened by 0805 and EPI pen given at this time. By 0807 patient was feeling much better- HR 81, BP 134/75, no SOB. Patient chest and face flushed. Taken to ED at 0812.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Flushing, Hypertension, Tachycardia
Clinical narrative: Employee received the  Pfizer covid vaccine @ 0752. @ 0800 employee  began to feel flushed, SOB, increased HR. Patient also had some throat tightness and itchiness. BP 147/95. O2 100% HR 149 @ 0755. Symptoms worsened by 0805 and EPI pen given at this time. By 0807 patient was feeling much better- HR 81, BP 134/75, no SOB. Patient chest and face flushed. Taken to ED at 0812.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: Employee received the  Pfizer covid vaccine @ 0752. @ 0800 employee  began to feel flushed, SOB, increased HR. Patient also had some throat tightness and itchiness. BP 147/95. O2 100% HR 149 @ 0755. Symptoms worsened by 0805 and EPI pen given at this time. By 0807 patient was feeling much better- HR 81, BP 134/75, no SOB. Patient chest and face flushed. Taken to ED at 0812.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Flushing, Heart rate increased, Throat irritation, Throat tightness
Clinical narrative: Patient received her first COVID-19 vaccine ~0755 AM of 12/29/20 & developed shortness of breath, dizziness, tachycardia (HR 140s), hypertension (SBP 160s), throat tightening, and chest flushing ~10 minutes after administration.  Patient received epinephrine 0.3 mg IM after developing symptoms. Symptoms resolved after administration of epinephrine. Patient was brought to the ER shortly after.  1000 mL of 0.9 NaCl, Diphenhydramine 50 mg IV, methylprednisolone 125 mg IV, and famotidine 20 mg IV x 1 were given ~830-845 in the ER.  Patient was discharged in stable condition with a prescription for prednisone 20 mg daily x 5 days and OTC Benadryl as needed.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Flushing, Hypertension, Tachycardia
Clinical narrative: Patient received her first COVID-19 vaccine ~0755 AM of 12/29/20 & developed shortness of breath, dizziness, tachycardia (HR 140s), hypertension (SBP 160s), throat tightening, and chest flushing ~10 minutes after administration.  Patient received epinephrine 0.3 mg IM after developing symptoms. Symptoms resolved after administration of epinephrine. Patient was brought to the ER shortly after.  1000 mL of 0.9 NaCl, Diphenhydramine 50 mg IV, methylprednisolone 125 mg IV, and famotidine 20 mg IV x 1 were given ~830-845 in the ER.  Patient was discharged in stable condition with a prescription for prednisone 20 mg daily x 5 days and OTC Benadryl as needed.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: Patient received her first COVID-19 vaccine ~0755 AM of 12/29/20 & developed shortness of breath, dizziness, tachycardia (HR 140s), hypertension (SBP 160s), throat tightening, and chest flushing ~10 minutes after administration.  Patient received epinephrine 0.3 mg IM after developing symptoms. Symptoms resolved after administration of epinephrine. Patient was brought to the ER shortly after.  1000 mL of 0.9 NaCl, Diphenhydramine 50 mg IV, methylprednisolone 125 mg IV, and famotidine 20 mg IV x 1 were given ~830-845 in the ER.  Patient was discharged in stable condition with a prescription for prednisone 20 mg daily x 5 days and OTC Benadryl as needed.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain
Clinical narrative: Chills, fatigue and L shoulder soreness at injection site
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Lethargy
Clinical narrative: Acute headache for 48 hours Acute  lethargy for 48 hours Minor pain at injection site for 36 hours
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Injection site pain, Neck pain, Pain
Clinical narrative: Soreness of left arm radiating to left upper neck and numbness of left hand, pulling sensation of left side of neck
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness of left arm radiating to left upper neck and numbness of left hand, pulling sensation of left side of neck
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Livedo reticularis, Skin warm, Throat tightness, Tongue disorder, Tremor
Clinical narrative: called to observation area at 1020.  98/60 p 100.  stated felt shaky, tongue feels thick and not changing, skin warm, hands, face, neck mottled.  respirations not labored.  oriented.   rapid response called and arrived at 1025.  transported to ER per wc as stated throat getting tighter.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Nausea, Oesophageal spasm
Clinical narrative: Severe nausea   Esophageal spasm.  Could not swallow
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash to anterior chest and posterior back and generalized itch that worsened over 10 minutes.  Was monitored post vaccine by blood pressure and pulse ox and medicated with Prednisone 20mg, Benadryl 25mg po  and Pepcid 20mg. Monitored for 3 hours with improvement in rash and symptoms of itch.  No SOB, NO wheezing or angioedema during course of event. Was released home without further adverse events
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Injection site pain
Clinical narrative: Nausea and lightheadedness on day of the vaccine.   By that night, fever, chills, headache, shaking, body aches and local pain at site of injection.   Nausea gone the next morning.   Fever lasted 36 hrs.   Body aches and headache lasted 48 hrs.   Fatigue lasted 3 days.   Side effects resolved by 4 days.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Tremor
Clinical narrative: Nausea and lightheadedness on day of the vaccine.   By that night, fever, chills, headache, shaking, body aches and local pain at site of injection.   Nausea gone the next morning.   Fever lasted 36 hrs.   Body aches and headache lasted 48 hrs.   Fatigue lasted 3 days.   Side effects resolved by 4 days.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Eyelid ptosis, Hypoaesthesia, Oedema peripheral
Clinical narrative: 12/27/2020 joint pain, body aches,  sinus congestion,  chest and throat soreness; . l cheek numb, sluggish.; left eyelid more raised and sluggish than other 12/28/2020; l armpit swollen armpit.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Sinus congestion, Sluggishness
Clinical narrative: 12/27/2020 joint pain, body aches,  sinus congestion,  chest and throat soreness; . l cheek numb, sluggish.; left eyelid more raised and sluggish than other 12/28/2020; l armpit swollen armpit.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Nausea, Vomiting
Clinical narrative: Nausea; vomiting; diarrhea; fatigue; headache
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Nausea, Pain, Rash
Clinical narrative: She was vaccinated 12/23. Initially she had some soreness,  nausea, diarrhea, extreme fatigue, but no fever. Two days later, she developed a diffuse erythematous rash on her bilateral arms, chest and neck with sharply delineated white patches. She also describes that her hands were purple, almost cyanotic appearing. The rash was not itchy or painful and lasted about 6 hours before going away completely.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Skin discolouration
Clinical narrative: She was vaccinated 12/23. Initially she had some soreness,  nausea, diarrhea, extreme fatigue, but no fever. Two days later, she developed a diffuse erythematous rash on her bilateral arms, chest and neck with sharply delineated white patches. She also describes that her hands were purple, almost cyanotic appearing. The rash was not itchy or painful and lasted about 6 hours before going away completely.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Vaccine administered via SubQ pinching technique in upper left posterior arm, midway between shoulder and elbow. NOT an IM injection. Site red, swollen and tender. Concern raised for less immune response. No training given to administration staff by hospital clinic.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Injection site pain, Paraesthesia
Clinical narrative: paresthesia along ipsilateral arm (ulnar nerve distribution) a few minutes after vaccination soreness at injection site, mild headache, & lightheadedness 1-2 hours after vaccination chills 4 hours after vaccination (but no fever) * most symptoms improved/resolved 8 hours after vaccination
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Moderna COvid-19 vaccine eua
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Rash erythematous, Rash pruritic
Clinical narrative: 6 days after receiving my initial covid vaccine, I began to develop an itchy rash. The rash started in the morning of 12/28/2020, beginning with itchy, red ankles. Progressed over the next 8 hours over my whole body. Red, raised, itchy patches. No other associated symptoms and no other means of explaining allergic reaction (no new meds, foods, clothing, detergents). Left work, took Benadryl and a shower. Rash subsided. I feel fine today.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Headache
Clinical narrative: Developed headache rated 9/10, feeling hot and light headed.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Impaired work ability, Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: Pain both right and left arms and left side of neck with tingling of the lips, palms of hand and soles of the feet. Mild headache. Mild chest pains at 1900 same day. Performed breathing exercises and yoga. Took a 1.5 mile walk. Took 1000mg of Tylenol and 12.5mg of Benadryl at 1900. Pain was relieved but tingling around the mouth persist even today 12/29/20 with leg muscle tingling and stiffness in the left neck . I had to take off work 12/28/20 due to severe pain left neck. Same symptoms I have when I take the tetany vaccine.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: Pain both right and left arms and left side of neck with tingling of the lips, palms of hand and soles of the feet. Mild headache. Mild chest pains at 1900 same day. Performed breathing exercises and yoga. Took a 1.5 mile walk. Took 1000mg of Tylenol and 12.5mg of Benadryl at 1900. Pain was relieved but tingling around the mouth persist even today 12/29/20 with leg muscle tingling and stiffness in the left neck . I had to take off work 12/28/20 due to severe pain left neck. Same symptoms I have when I take the tetany vaccine.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site swelling, Pain in extremity
Clinical narrative: Moderate  arm pain and swelling at site of injection.
Age: 21.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Cellulitis, Chills, Headache, Injection site infection, Pyrexia
Clinical narrative: Patient vomited about eight hours after the shots. She developed a huge infection in the right arm where she received the Pheumoccoccal vaccine.  She spiked a fever, headache, chills.  Two days after the shot she went to an urgent care center.  She returned to see doctor on 11/22/2019 and 11/23/2019.  She then went to the ER at Hospital.
Age: 21.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Vomiting
Clinical narrative: Patient vomited about eight hours after the shots. She developed a huge infection in the right arm where she received the Pheumoccoccal vaccine.  She spiked a fever, headache, chills.  Two days after the shot she went to an urgent care center.  She returned to see doctor on 11/22/2019 and 11/23/2019.  She then went to the ER at Hospital.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Hyperhidrosis, Hypoaesthesia, Pain
Clinical narrative: Patient reports freezing and sweating for 2 days after immunization 12 days ago. Body aches and headaches have persisted since then. Also reports numbness going down left arm to all fingertips since vaccine.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Nasal congestion, Paraesthesia oral, Tachycardia, Taste disorder
Clinical narrative: 2-3 minutes after injection, experienced what felt like a drop in blood pressure, tachycardia, tongue tingling and taste, and for a few seconds, my nose stuffed up but then all symptoms went away within a few minutes. I felt completely fine 5 minutes later.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Feeling hot, Headache, Pain in extremity
Clinical narrative: Went to hair appointment and water aerobics after vaccination. Arm started to hurt a lot. Went to bed at 10pm and at 12am was feeling really hot with a headache, chills, and shivering. Temp was 99.4.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea
Clinical narrative: trouble breathing
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Heart rate increased, Hyperhidrosis, Paraesthesia, Throat irritation
Clinical narrative: trouble breathing
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Swelling face
Clinical narrative: ON THE THIRD DAY I FEEL LIKE PINS ON MY BACK AND A SLOPE CAME OUT OF MY NOSE AND ON MY LIP. I TAKE BENADRYL TABLETS 50MG  TWO TIMES.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Headache, Myalgia, Nausea, Tremor
Clinical narrative: muscle pains, shakes, 100.3 temp, headache, nausea
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Paranasal sinus hypersecretion, Pyrexia
Clinical narrative: Fever, body weakness, headache, sinus drainage
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Feeling hot, Hyperhidrosis, Loss of consciousness
Clinical narrative: called to observation area 10:50 - report that patient passed out, was on stretcher, reported did not fall, 'came to' in less than 1 minute.  108/68, P 70 and strong, alert and oriented.  states feels anxious about flu shots.  felt lightheaded, hot, sweaty, skin pale and warm.  at 1052 rapid response arrived.  states feeling better, had had food/fluids today.   assessed that not allergic response - vaso/vagel.  1055 sat up and feeling good, skin pink.  1100 to chair.  1115 left area walking.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pallor, Presyncope, Skin warm
Clinical narrative: called to observation area 10:50 - report that patient passed out, was on stretcher, reported did not fall, 'came to' in less than 1 minute.  108/68, P 70 and strong, alert and oriented.  states feels anxious about flu shots.  felt lightheaded, hot, sweaty, skin pale and warm.  at 1052 rapid response arrived.  states feeling better, had had food/fluids today.   assessed that not allergic response - vaso/vagel.  1055 sat up and feeling good, skin pink.  1100 to chair.  1115 left area walking.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Nausea
Clinical narrative: Patient felt lightheaded, flushed and nauseous.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Bilevel positive airway pressure, Endotracheal intubation, Guillain-Barre syndrome, Immunoglobulin therapy, Muscular weakness
Clinical narrative: Patient, 61 y.o. male who presented to ED on 11/18/20 with bilateral upper and lower extremity weakness s/p influenza vaccination on 11/9/20.   ? Patient received IIV4 ? Fluzone (Sanofi Pasteur) Lot #UT7102KA.   ? Neurology consulted on 11/18/20, started IVIG 0.4mg/kg/day x5 days for Guillain-Barre diagnosis.   ? Patient?s case was further complicated by respiratory failure requiring BIPAP, then intubation and eventual transfer to MC for concern of seizure and EEG monitoring
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Respiratory failure
Clinical narrative: Patient, 61 y.o. male who presented to ED on 11/18/20 with bilateral upper and lower extremity weakness s/p influenza vaccination on 11/9/20.   ? Patient received IIV4 ? Fluzone (Sanofi Pasteur) Lot #UT7102KA.   ? Neurology consulted on 11/18/20, started IVIG 0.4mg/kg/day x5 days for Guillain-Barre diagnosis.   ? Patient?s case was further complicated by respiratory failure requiring BIPAP, then intubation and eventual transfer to MC for concern of seizure and EEG monitoring
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Pain
Clinical narrative: Headache, fever 101.8, chills, aches, joint and muscle pain.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache, fever 101.8, chills, aches, joint and muscle pain.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Approximately 1 and 1/2 hours after the injection, her tongue became thick, lips swelled, chest pain, short of breath and headache. Injections site was red and swollen. She was traveling out of town  and called an urgent care and was advised to take  50 mg of Benadryl q 4 hours till swelling was gone. She took it for 4 days. She saw here PCP on 12/21/2020.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Tongue disorder
Clinical narrative: Approximately 1 and 1/2 hours after the injection, her tongue became thick, lips swelled, chest pain, short of breath and headache. Injections site was red and swollen. She was traveling out of town  and called an urgent care and was advised to take  50 mg of Benadryl q 4 hours till swelling was gone. She took it for 4 days. She saw here PCP on 12/21/2020.
Age: 29.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Feeling of body temperature change, Headache, Influenza like illness, Pain
Clinical narrative: I had intense flu like symptoms the night of taking the vaccine. Uncontrollably shivering, intense body aches,  going from being very hot and very cold.   The morning of I woke up with a bad headache and body aches.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Feeling abnormal, Oral herpes, Pain in extremity
Clinical narrative: Didn't feel good, soreness on arm.  Monday I had chills Uncomfortable at work Took Antibiotics Chills  Possible UTI  the following Wednesday I discovered a cold sore on lip
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Dyspnoea, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Called and spoke with patient, the received her COVID vaccine yesterday. Since the vaccine she had a temp of 99.9 last night, has not checked today, feeling a little warm today but not as warm as last night. The area is hot and red and swollen in the size of a golf ball, was bigger yesterday. Her entire body feels itchy. She did take benadryl approx 5 hours ago, it helped a little bit right away but now she feels no relief again. She states she has small little bumps that have slowly been spreading from the arm of injection to back and now onto other arm.    Does report she felt like she needed her inhalers, now denies and swelling or itching of mouth throat or tongue. No difficulty breathing at this point.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Skin warm
Clinical narrative: Called and spoke with patient, the received her COVID vaccine yesterday. Since the vaccine she had a temp of 99.9 last night, has not checked today, feeling a little warm today but not as warm as last night. The area is hot and red and swollen in the size of a golf ball, was bigger yesterday. Her entire body feels itchy. She did take benadryl approx 5 hours ago, it helped a little bit right away but now she feels no relief again. She states she has small little bumps that have slowly been spreading from the arm of injection to back and now onto other arm.    Does report she felt like she needed her inhalers, now denies and swelling or itching of mouth throat or tongue. No difficulty breathing at this point.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: RASH AND HIVES TO NECK.  BENEDRYL AND PREDNISONE.  SYMPTOMS STARTED AT 4:00 VACCINE ADMINISTERED AT 1:00
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: 5 hours after injection my legs from the knee to the ankle joint became very itchy, I wrapped them both in a cool wet towel to keep the itching down. This lasted for 48 hours and then went away.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, HIV antibody negative, Heart rate increased, Hyperhidrosis
Clinical narrative: During first few minutes after the vaccination, the client began to cough repeatedly.  She stated that her throat was tingling and she was noted to be diaphoretic, with Shortness of breath, an increased heart rate and hives.  Epinephrine 0.3 mg IM given to client.  Client responded with less diaphoresis and cough subsided.  However, noted in 5 more minutes that the symptoms progressed.  (As we were in a hospital area administering the vaccine),  a rapid response team was activated and she was sent to the ER for further evaluation monitoring and treatment.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal paraesthesia
Clinical narrative: During first few minutes after the vaccination, the client began to cough repeatedly.  She stated that her throat was tingling and she was noted to be diaphoretic, with Shortness of breath, an increased heart rate and hives.  Epinephrine 0.3 mg IM given to client.  Client responded with less diaphoresis and cough subsided.  However, noted in 5 more minutes that the symptoms progressed.  (As we were in a hospital area administering the vaccine),  a rapid response team was activated and she was sent to the ER for further evaluation monitoring and treatment.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash macular
Clinical narrative: intermittent itching, some blotchy rednesss no hives or raised rash  that lasted about 3 hours, went away on its own without any treatment
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: Employee reported numbness and tingling in upper lip 10 minutes after receiving vaccine. Employee was transported to Emergency Department for evaluation.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: low grade fever- 99.9  sore arm
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hot flush
Clinical narrative: Hot flush  Dull headache
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, Sneezing
Clinical narrative: Day 1-after immunization covid 19 moderna vaccine-headache, sneezing, low grade temp 99 when she arrived home Day 2-102F-took tylenol as needed, she continue to experience headaches, body aches Day 3- No signs or symptoms, temp 97.6F with out tylenol
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Local reaction: Pain and swollen arm in the injection spot for over 2 days
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Lip swelling, Pruritus
Clinical narrative: 14 hours after injection woke up with swollen upper lip and extreme systemc itching. Took 50 mg Benadryl. 12/26/2020 at 0900 continued itching took claritin 10mg and 25 mg Benadryl lip still swollen.12/26/2020 @2000 took 25mg benadryl for itching lip no longer swollen. 12/27/2020 itching has now become burning sensation systemically took 25 mg benadryl and 10mg Claritin. Upper lip swollen 12/27/2020 @ 2000 took 25 mg benadryl for continue burning and itching Lip no longer swollen. 12/28/2020 @ 0600 took 10 mg claritin till itching no burning. 12/28/2020 at 2100 took benadryl 25 mg for continued itching. 12/29/2020 0600 took claritin 10 mg for itching.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomiting within 15 minutes Fever 1 hr post vaccination Continued vomiting
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on chest
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Mobility decreased, Muscle spasms, Pain in extremity, Throat irritation
Clinical narrative: Scratchy throat within minutes. Left thigh pain and spasms, left arm pain. The next morning I can't lift my arm above shoulder, thigh pain not as bad, diarrhea at 9:30 am.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: Erythematous rash over anterior torso, groin, flexor aspect of elbows/knees/hips
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Fatigue
Clinical narrative: 12/28/2020 weakness, fatigue, chills, tongue swollen, left arm pain at injection site 12/29/2020 fever 101.00 headache, loss of appetite, weakness, fatigue, dizziness, throat swollen
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Pyrexia, Swollen tongue
Clinical narrative: 12/28/2020 weakness, fatigue, chills, tongue swollen, left arm pain at injection site 12/29/2020 fever 101.00 headache, loss of appetite, weakness, fatigue, dizziness, throat swollen
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site swelling (~6 cm across), redness, and tenderness beginning 12/28, resolved when patient took benadryl
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash papular
Clinical narrative: developed raised red bumps on arms and legs several hours after receiving vaccine.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Impaired work ability, Muscle strain
Clinical narrative: Debilitating, severe neck and shoulder pain the next day that continued for a week Stiff neck, spread to back pain Unable to work/left work early Still have stiff neck and feel strain doing my normal day-to-day tasks
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Neck pain
Clinical narrative: Debilitating, severe neck and shoulder pain the next day that continued for a week Stiff neck, spread to back pain Unable to work/left work early Still have stiff neck and feel strain doing my normal day-to-day tasks
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Fatigue, Headache, Injection site pain, Pain
Clinical narrative: Day 1-after Covid 19-Moderna injection-employee experienced an extreme pounding headache, her blood pressure was elevated 161/93. Evening hours employee reported fatigue, rash to chest/back no itching, along with fever 102F  Day 2-Employee continued with fever 100.2 F and rash to chest/back no itching-taking Motrin and Tylenol  Day 3-No fever, no rash, pain to injection site and generalized body aches Day 4-No symptoms
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: Day 1-after Covid 19-Moderna injection-employee experienced an extreme pounding headache, her blood pressure was elevated 161/93. Evening hours employee reported fatigue, rash to chest/back no itching, along with fever 102F  Day 2-Employee continued with fever 100.2 F and rash to chest/back no itching-taking Motrin and Tylenol  Day 3-No fever, no rash, pain to injection site and generalized body aches Day 4-No symptoms
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Laboratory test normal, Palpitations, Sinus tachycardia, Tachycardia
Clinical narrative: 38 y.o. female who arrived by Clinic/physician office presented to the emergency department for Concern for possible allergic reaction.  Patient was receiving the Covid vaccine today and while waiting during the observation.  She felt some palpitations and was found to have some tachycardia.  She was sent here for further evaluation.  Currently she says she feels fine and denies any swelling, rashes, difficulty breathing or wheezing.  She has not had any allergic reactions in the past and has never had any issues with shots or vaccinations before.  She does not have any pain or swelling at the injection site.  She was initially heart rate in the 120s but during exam is 100-105.  She denies any shortness of breath, chest pain, lightheadedness and does not think she is feeling anxious at all.  o ECG (My read): Sinus tachycardia, normal intervals, no ST elevations or depressions and no T wave inversions or signs of right heart strain o Patient did start to feel palpitations again, her heart rate periodically drops into the 90s and then jumps back up into the 1 teens.  Considering this, did obtain basic labs all of which were completely normal.  Her heart rate has improved, did order Zio patch for monitoring over the next 7 days and recommend she follow-up with her PCP for results on this.  Otherwise appears well with no signs of allergic reactions or other emergent concerns.  Discharged in stable condition with return precautions given
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Paraesthesia
Clinical narrative: Developed a severe headache around 1 PM of the day she received her vaccine, some general tingling non-specific; sever headache lasted until 9 PM that evening, relieved with medication but in the morning continued to have headache although more mild then previously.  Was better by the 3rd day.
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Asthenia, Blood culture negative, Electrocardiogram normal, Hypotonia, Influenza virus test negative
Clinical narrative: Per ER discharge paperwork: Vaccines administered to patient. Approximately 4 hours after vaccines were administered, patient became very weak, poor muscle tone and vomiting. Patient was taken to the ER and given IV fluids and Zofran. Patient was admitted to the hospital for 24 hours for observation because of neurological status/altered mental status.
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Laboratory test normal, Mental status changes, SARS-CoV-2 test negative, Urine analysis normal, Vomiting
Clinical narrative: Per ER discharge paperwork: Vaccines administered to patient. Approximately 4 hours after vaccines were administered, patient became very weak, poor muscle tone and vomiting. Patient was taken to the ER and given IV fluids and Zofran. Patient was admitted to the hospital for 24 hours for observation because of neurological status/altered mental status.
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: White blood cell count increased
Clinical narrative: Per ER discharge paperwork: Vaccines administered to patient. Approximately 4 hours after vaccines were administered, patient became very weak, poor muscle tone and vomiting. Patient was taken to the ER and given IV fluids and Zofran. Patient was admitted to the hospital for 24 hours for observation because of neurological status/altered mental status.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Pain at injection site
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hypoaesthesia
Clinical narrative: Numbness in nose tip of tongue; earlobes warm
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Pain in extremity, Paraesthesia, Peripheral coldness
Clinical narrative: Severe right arm soreness inability to have range of motion cannot pick up items over 5 lbs numbness and tingling and cooler fingers in rt hand
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Weight bearing difficulty
Clinical narrative: Severe right arm soreness inability to have range of motion cannot pick up items over 5 lbs numbness and tingling and cooler fingers in rt hand
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Fatigue, chills, body aches, mild cough, headache, sweats for 36 hours Arm soreness for 5 days
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Fatigue, chills, body aches, mild cough, headache, sweats for 36 hours Arm soreness for 5 days
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Injection site pain
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Approximately 5 minutes after administration of vaccine, patient felt nauseated and vomited with some relief.  Blood pressure was checked (171/94).  Approximately 50 minutes @09:20am after administration of vaccine, patient complained of mild headache.  Blood pressure was checked (148/96).  At 09:35am, patient reports no nausea.  Continues with mild headache.  Patient clinically stable.  No medications administered.  At 10:05am patient reports headache still present but is gradually subsiding.  Patient was released at 10:10am.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Nasal discomfort
Clinical narrative: 2 minutes after injection patient c/o head heaviness, nose tightness.  VS: BP 159/88, HR 101, O2 SAT 99%, RR 24
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Paraesthesia
Clinical narrative: Patient came into the pharmacy yesterday (12/29/2020) reporting tingling in the upper arm that started after getting the flu shot. She remembers the tingling started the Friday after getting the shot, 6 days later. She stated she was traveling that week. On 11/21/2020 she got the shingrix vaccine on the same side as the flu shot. She stated that the tingling has increase in frequency since getting the shingrix vaccine. She reported the tingling comes and goes, has increase in frequency, and only occurs in the upper arm.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Pain, Pyrexia
Clinical narrative: sore injection site, aches, fever over 100 degrees, aches, exhausted, chills,
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm
Clinical narrative: Approximately 15 minutes after administration of vaccine, patient experienced twitching on left upper eyelid off-and-on for approximately 10 minutes.  Twitching resolved.  Blood pressure was checked at 09:50am (161/109).  HR=76.  Patient clinically stable.  No medications were administered.  Patient was advised to follow-up with PCP regarding blood pressure concerns and released at 10:10am.
Age: 1.08
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: an expired MMR-11 that was administered to a 13 month old patient yesterday; This spontaneous report was received from a nurse refers to a 52-week-old patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided      On 21-DEC-2020, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II), 0.5 milliliter, subcutaneous, lot number R028381, expiration date 03-OCT-2020 for prophylaxis.  The vaccine had no previous temperature excursions and was properly stored up to the administration.
Sex: F
Vaccine: MMR
Symptoms: Extra dose administered, Vaccination failure
Clinical narrative: Had MMR vaccine four times because she never developed immunity to it until the fourth round; Had MMR vaccine four times because she never developed immunity to it until the fourth round; This spontaneous report was received from a White female patient, who would be 32 years old at the reporting time and was also a midwife, via Pfizer. The patient was referring to herself. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On unknown dates, the patient was vaccinated with four doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (formulation, dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis because she did not develop immunity until the fourth round (vaccination failure and extra dose administered).  The outcome of the event was unknown.  The causality assessment between the vaccination failure and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) was not provided.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient tested positive for COVID-19 after / dose one of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of covid-19 in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th August 2020, the patient received the 1st dose of Shingrix. On an unknown date, between 2 and 3 months after receiving Shingrix, the patient experienced covid-19. On an unknown date, the outcome of the covid-19 was unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.  Additional details were provided as follows: The patient tested positive for COVID-19 after she had received dose one of Shingrix. It was reported that the patient tested positive for COVID-19 approximately one month ago, no exact date provided. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: 66 year old female patient received a two doses of Fluzone Quadrivalent High Dose, no AE; Initial information received on 23-Nov-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 66 years old female patient who received vaccine two doses of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] [extra dose administered]..  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included CYANOCOBALAMIN (B12-VITAMIN).  On 12-Sep-2020, the patient received a 0.7 ml first dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ552AA and expiry date: 30-Jun-2021) and on 23-Nov-2020, the patient received same vaccine 0.7 ml second dose (lot UJ552AA and expiry date: 30-Jun-2021) via an intramuscular route in the left arm for prophylactic vaccination.  It was a case of actual medication error due to extra dose administered (latency on same day).  Reporter relationship: health care professional (HCP), Product used: used, First time product used: no, Still using product: no  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 66.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 66 year-old patient accidentally received Menactra vaccine who was supposed to get a Pneumococcal vaccine/no AE; 66 year old patient accidentally received Menactra vaccine/no AE; Initial information regarding an unsolicited valid non-serious case was received on 22-Dec-2020 from a Nurse Practitioner. This case involves a 66-year-old female patient who was accidentally vaccinated with 0.5 mL (once) dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6690AB and expiry date 23-Aug-2021) via an intramuscular route at the left deltoid on 19-Dec-2020 for prophylactic vaccination instead of PNEUMOCOCCAL VACCINE (Wrong product administered) and (Product administered to patient of inappropriate age).  Medical history, past medical treatment, past vaccination and family history were not provided.  No concomitant medication (no other vaccines) was given.   It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (latency was on same day).  At the time of report, no side effects reported.  Product used : Used  Still using product : No  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Injection Site Pain
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Hyperhidrosis, Pain in extremity, Pyrexia
Clinical narrative: Experienced fever, chills, sweats, joint pain and soreness in Right arm
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: Fever, chills, headache, arm soreness
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Blood electrolytes normal, Chills, Diarrhoea, Ear discomfort, Full blood count normal
Clinical narrative: After receiving the vaccination, I experienced slight soreness at the site of the injection and a mild headache every day until Friday 12/25. Starting Friday  evening 12/25 I started to experience tingling around my jaw  after flossing my teeth. It continued when I woke up the next day and spread to my chin and around my lips. I now feel the sensation on my forehead as well. In addition to this I have been having chills, runny nose, pressure in my face, head, and ears, had diarrhea X1 and have been nauseous . I tested COVID negative on 12/28 and had my electrolytes checked along with CBC which all came back normal. Today 12/29 I took 2 Benadryl in the event it could help an allergic reaction.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Injection site pain, Nausea, Paraesthesia
Clinical narrative: After receiving the vaccination, I experienced slight soreness at the site of the injection and a mild headache every day until Friday 12/25. Starting Friday  evening 12/25 I started to experience tingling around my jaw  after flossing my teeth. It continued when I woke up the next day and spread to my chin and around my lips. I now feel the sensation on my forehead as well. In addition to this I have been having chills, runny nose, pressure in my face, head, and ears, had diarrhea X1 and have been nauseous . I tested COVID negative on 12/28 and had my electrolytes checked along with CBC which all came back normal. Today 12/29 I took 2 Benadryl in the event it could help an allergic reaction.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test negative
Clinical narrative: After receiving the vaccination, I experienced slight soreness at the site of the injection and a mild headache every day until Friday 12/25. Starting Friday  evening 12/25 I started to experience tingling around my jaw  after flossing my teeth. It continued when I woke up the next day and spread to my chin and around my lips. I now feel the sensation on my forehead as well. In addition to this I have been having chills, runny nose, pressure in my face, head, and ears, had diarrhea X1 and have been nauseous . I tested COVID negative on 12/28 and had my electrolytes checked along with CBC which all came back normal. Today 12/29 I took 2 Benadryl in the event it could help an allergic reaction.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Paraesthesia oral
Clinical narrative: burning from shoulder to tips of fingers when administered, tingling tongue, tingling around lips
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Differential white blood cell count, Eye pain, Full blood count
Clinical narrative: Patient began with muscle/body aches and chills on 12/24. Highest temperature recorded was 99.8, took ibuprofen. On 12/25, lymph nodes near right clavicle and right axilla swollen and stiffness in neck and shoulder. Right foot also became swollen. On 12/27, developed pain behind eyes, swelling began decreasing on 12/27. Began having headache on 12/28.