chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Dizziness, Headache
Clinical narrative: dizziness, vertigo nausea  diarrhea  chills weakness headache
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vertigo
Clinical narrative: dizziness, vertigo nausea  diarrhea  chills weakness headache
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Pain, Productive cough, Pyrexia
Clinical narrative: Employee received vaccine on afternoon of 12/22/2020 at clinic  She states she did have COVID previously in November.  She called in this morning with vomiting and now has fever of 101.9, headache, body aches,fever, productive cough, loss of appetite,  She has contacted her PCP for suggesntions.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Employee received vaccine on afternoon of 12/22/2020 at clinic  She states she did have COVID previously in November.  She called in this morning with vomiting and now has fever of 101.9, headache, body aches,fever, productive cough, loss of appetite,  She has contacted her PCP for suggesntions.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Palpitations, Vision blurred
Clinical narrative: Pt C/O blurry vision, palpitations and sweating for 3 seconds. this occurred 10 minutes after receiving vaccine.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Developed redness and warmth and some swelling at injection site that began about 7 hours after injection and grew in size to about 3 inches the next day.  It did itch but otherwise some discomfort pain to area.  By day 5 the area had almost healed entirely.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Headache, Immediate post-injection reaction
Clinical narrative: Metallic taste in mouth immediately Headache that lasted days
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Sensation of foreign body
Clinical narrative: About 12 minutes after receiving covid vaccine, pt felt like she had a lump in her throat.  No difficulty breathing or swallowing.  No facial swellling. Pt was evaluated by PA from urgent care.  Pt was transferred to urgent care for antihistamine administration.  Vitals remained stable.  12/23/20 @ 1212: Note copied from UC Visit: Diagnosis Allergic reaction (ICD10-CM T78.40XA, Working, Medical). Summary:  0916 "Lump is still there but much smaller" Still no sign of intraoral swelling 0925 Patient reports symptoms have almost resolved completely, comfortable going home. Instructed to take Zyrtec tonight before work and for the next couple of days and to go to hospital for SOB, worsening sensation of lump in throat. Patient verbalized understanding and is in agreement with treatment plan. Opportunity for questions was given, all questions answered.. Pharmacy: diphenhydrAMINE (Benadryl) AMB (Order): 25 mg, IM, InOffice.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Abdominal pain upper, Diarrhoea
Clinical narrative: About 4 hours later I began have tightness in my abdomen and cramping, followed by gastrointestinal upset and diarreha and pain in my upper abdomen. I will wait and see if it resolves by tomorrow before going to the hospital for care.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Injection site nodule, Injection site warmth, Neck pain, Pain in extremity
Clinical narrative: Pt stated she had a reaction to the Covid-19 vaccine. Pt states she cannot raise her arm, where she got the injection is very hot to the touch, and she has pain all the way up to her neck. A slight knot at injection site.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: mild transient rash with some welts, but mostly redness and itching located on right foot and ankle. Took diphenhydramine 50 mg po x 1 dose and used hydrocortisone cream x 1 application.  Rash resolved in that location, but came up on both thighs just above the knee cap on both legs on Sunday.  Repeated diphenhydramine 50 mg po x 1 and used hydrocortisone 1% cream x 1 application.  Both events resolved within 2 hours, with no further issues.  This could be unrelated since it was 4 days out, but I wanted to report it for consideration.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Impaired work ability, Nasal congestion, SARS-CoV-2 test positive
Clinical narrative: On 12/18 feeling congestion and stuffy nose was able to go work that night as well 12/19. Then on 12/21 realized lost taste/smell went to get test for Covid  results positive. As of 12/23 still haven't gain taste/smell. I had to miss 10 days of work.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Progress Notes MD (Physician) ? ? Endocrinology    COVID VACCINE CLINIC 12/22/2020    Patient: Date:  12/22/2020                                                                                           Subjective Patient is a 42 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination.    Afebrile 98.6   She denied any history of previous adverse reactions to vaccines.   She was given the Pfizer vaccination in the right deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience dizziness.  She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including rapid progression of symptoms, respiratory distress with wheezing and dyspnea, vomiting, abdominal pain, hypotension, dysrhythmia, chest pain and collapse.   Vitals were normal Checked her blood sugars-normal at 108  Offered her snack/water-she declined.   Repeat BP normal at 112/72     Vitals:   12/22/20 1737 BP: 126/82 Pulse: 87 SpO2: 100%          Objective     Physical Exam Vitals signs reviewed.  Constitutional:      Appearance: Normal appearance. She is normal weight.  HENT:     Head: Normocephalic and atraumatic.     Nose: Nose normal.     Mouth/Throat:     Mouth: Mucous membranes are moist.     Pharynx: Oropharynx is clear.  Eyes:     Extraocular Movements: Extraocular movements intact.     Conjunctiva/sclera: Conjunctivae normal.     Pupils: Pupils are equal, round, and reactive to light.  Neck:     Musculoskeletal: Normal range of motion and neck supple.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Pulses: Normal pulses.     Heart sounds: Normal heart sounds.  Pulmonary:     Effort: Pulmonary effort is normal.     Breath sounds: Normal breath sounds.  Abdominal:     General: Abdomen is flat. Bowel sounds are normal.     Palpations: Abdomen is soft.  Musculoskeletal: Normal range of motion.  Skin:    General: Skin is warm and dry.  Neurological:     General: No focal deficit present.     Mental Status: She is alert and oriented to person, place, and time.  Psychiatric:        Mood and Affect: Mood normal.        Behavior: Behavior normal.        Thought Content: Thought content normal.        Judgment: Judgment normal.         Assessment/Plan  Treatment included: no therapy. Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP.           MD Electronically Signed 12/22/2020 5:38 PM
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Patient reports after she received the vaccine she reported to the observation area for the 30 minute monitoring period and reported feeling her heart racing.  Patient with hx of histamine intolerance and angioedema, so carries epi pen with her.  Patient notified monitors of her symptoms and her medical hx and that she had her epi pen with her.   Patient reports ?heart racing? and recorded 130 BPM on activity tracker.  Pt endorses history of anxiety and panic attacks.  Patient reports resolution of symptoms at approximately 8:15 am, resting HR at that time 97-98 BPM.  Patient denies any other symptoms.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Flushing, Headache, Pruritus
Clinical narrative: Rash, Flush, felt hot, itchiness, headache, dizziness
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash, Flush, felt hot, itchiness, headache, dizziness
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Patient called and reported diarrhea, vomiting and nausea ~ 36 hours after vaccine was administered. Resolved in ~ 18 hours. Felt great the next day.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Redness with extreme swelling but about 6 inches beneath the injections site rather than right at the point of injection which is normally seen with Shingrix. No treatment was required, and a positive outcome was noted.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head abnormal, Facial paralysis, Facial paresis, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Right sided jaw pain started 12/22/20 in the AM progressed through the evening. When I woke I had numbness and weakness on the right side of my tongue which I quickly realized included the lower portion of my right face.  An ER trip and a CT scan confirmed it was Bells Palsy. The upper portion of my face has is now included in the weakness and paralysis.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, Tongue movement disturbance
Clinical narrative: Right sided jaw pain started 12/22/20 in the AM progressed through the evening. When I woke I had numbness and weakness on the right side of my tongue which I quickly realized included the lower portion of my right face.  An ER trip and a CT scan confirmed it was Bells Palsy. The upper portion of my face has is now included in the weakness and paralysis.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Headache, Herpes zoster
Clinical narrative: Temperature of 100.1 about 5 hours after administration with mild frontal headache. Today - about 24 hours after adminstration - herpetic rash developed along the left mandibular branch of the trigeminal nerve.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dry mouth
Clinical narrative: Patient given covid-19 vaccine at 1218, Symptoms started at 12:25 (dry cough, dry mouth). Benadryl 25mg by mouth given at 1238. No previous history of vaccination reaction. Of note: recent history of Clinically diagnosed bronchitis and treated with OTC medication (mucolytic) by pcp, no ATB given.  No NKDA, no recent fever or illness in 24hours. Initial VS: BP: 142/84, HR: 111, RR: 24 Spo2% 99/RA, . End VS: BP: 118/94, HR: 82, RR: 16,, SpO2: 100%/RA.  Patient denies shortness of breath or difficulty breathing, Lung sounds are clear. Patient states she feel better and is conscious alert and oriented X4. She was placed in  he monitoring room within the vaccination clinic for intermittent monitoring of VS and reaction response at 1317.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Erythema, Fatigue, Pain in extremity, Peripheral swelling
Clinical narrative: on 12/16/2020 my arm was red from the injection like everyone else but my symptoms began the next day on 12/17/2020 I was in the shower in the morning it was noticeably sore and the following day the 18th it was quite a bit bigger and red, I could still move my arm. I was overly tired and very sluggish  I went to the Dr on the 18th and they gave me a prescription for keflex and prednisode
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Sluggishness
Clinical narrative: on 12/16/2020 my arm was red from the injection like everyone else but my symptoms began the next day on 12/17/2020 I was in the shower in the morning it was noticeably sore and the following day the 18th it was quite a bit bigger and red, I could still move my arm. I was overly tired and very sluggish  I went to the Dr on the 18th and they gave me a prescription for keflex and prednisode
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Feeling hot, Flushing, Hypertensive urgency, Muscle tightness
Clinical narrative: Patient with past medical history significant for thyroid cancer was given  Pfizer COVID-19 vaccine at approximately 1430 at our facility. After receiving vaccine patient felt flushed, face hot, felt something squeezing neck (similar to tight collar). 25 mg PO diphenhydramine given X 1. Patient having shivering on and off. Felt swelling progress up into back of throat. Had to clear throat and swallow harder. At 1511 patient was checked into the emergency department at our hospital. At 1527 famotidine 20 mg IV once given. BP was found to be 232/100. Amlodipine 5 mg IV once given at 1909. Labetalol 10 mg IV once given at 1812, labetalol 20 mg IV once given at 2034, clonidine 0.1 mg PO once given at 2127. Patient sent home at approximately midnight. Diagnosed with possible anaphylaxis and hypertensive urgency (no history of HTN).
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: Patient with past medical history significant for thyroid cancer was given  Pfizer COVID-19 vaccine at approximately 1430 at our facility. After receiving vaccine patient felt flushed, face hot, felt something squeezing neck (similar to tight collar). 25 mg PO diphenhydramine given X 1. Patient having shivering on and off. Felt swelling progress up into back of throat. Had to clear throat and swallow harder. At 1511 patient was checked into the emergency department at our hospital. At 1527 famotidine 20 mg IV once given. BP was found to be 232/100. Amlodipine 5 mg IV once given at 1909. Labetalol 10 mg IV once given at 1812, labetalol 20 mg IV once given at 2034, clonidine 0.1 mg PO once given at 2127. Patient sent home at approximately midnight. Diagnosed with possible anaphylaxis and hypertensive urgency (no history of HTN).
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dysphagia, Feeling abnormal, Feeling hot, Hypertensive emergency
Clinical narrative: Patient with past medical history significant for thyroid cancer was given  Pfizer COVID-19 vaccine at approximately 1430 at our facility. After receiving vaccine patient felt flushed, face hot, felt something squeezing neck (similar to tight collar). 25 mg PO diphenhydramine given X 1. Patient having shivering on and off. Felt swelling progress up into back of throat. Had to clear throat and swallow harder. At 1511 patient was checked into the emergency department at our hospital. At 1527 famotidine 20 mg IV once given. BP was found to be 232/100. Amlodipine 5 mg IV once given at 1909. Labetalol 10 mg IV once given at 1812, labetalol 20 mg IV once given at 2034, clonidine 0.1 mg PO once given at 2127. Patient sent home at approximately midnight. Diagnosed with possible anaphylaxis and hypertensive urgency (no history of HTN).
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling, Throat clearing
Clinical narrative: Patient with past medical history significant for thyroid cancer was given  Pfizer COVID-19 vaccine at approximately 1430 at our facility. After receiving vaccine patient felt flushed, face hot, felt something squeezing neck (similar to tight collar). 25 mg PO diphenhydramine given X 1. Patient having shivering on and off. Felt swelling progress up into back of throat. Had to clear throat and swallow harder. At 1511 patient was checked into the emergency department at our hospital. At 1527 famotidine 20 mg IV once given. BP was found to be 232/100. Amlodipine 5 mg IV once given at 1909. Labetalol 10 mg IV once given at 1812, labetalol 20 mg IV once given at 2034, clonidine 0.1 mg PO once given at 2127. Patient sent home at approximately midnight. Diagnosed with possible anaphylaxis and hypertensive urgency (no history of HTN).
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Ten minutes after receiving Pfizer Covid vaccine shot in right shoulder, experienced partial numbing of the hands which persisted all day. Next day no numbing of left hand, but right hand still partially numb.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Injection site pain
Clinical narrative: Ten minutes after receiving Pfizer Covid vaccine shot in right shoulder, experienced partial numbing of the hands which persisted all day. Next day no numbing of left hand, but right hand still partially numb.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush
Clinical narrative: Patient complained of a rush of feeling hot.   Patient was laid supine, VS monitored.   Patient was transferred to the ED.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Presyncope
Clinical narrative: Right after patient was given vaccine injection he started to feel lightheaded and woozy. He had just worked the night shift and hadn't eaten anything. No prior illness reported. Patient brought to emergency department to be evaluated. Received 500ml of fluids and symptoms resolved and he went home. Diagnosis of near syncope.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives, administered Diphenhydramine 12.5mg po
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Limb discomfort, Myalgia
Clinical narrative: Muscle aches, chills arm discomfort
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia
Clinical narrative: Patient c/o numbness of arm and feeling like she is floating - resolved after 2-3 seconds
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Diffuse hives started ~ 12 hours post vaccine, progressively worsened to involve entire body, and required solumedrol & antihistamines at an Urgent Care visit
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Vision blurred, Visual impairment
Clinical narrative: On the night of 10/22/20 patient sat up suddenly and had  what she reports as, "75% dimming of the right eye," that lasted for about 5 minutes. Vitals at that time were BP 122/82,  p 72, o2 sat 97% on RA, and temp 97.8. (Patient is a CRNA) After confirming no other neurological deficits, patient laid down and experienced blurring of her left eye with left eye pain. No treatment given. Today she has no vision deficit or pain.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Palpitations, Supraventricular extrasystoles
Clinical narrative: Frequent palpitations - never experienced before EKG on 12/23 revealed frequent PAC's, sometimes with runs of PAC's
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea
Clinical narrative: Patient reports shortness of breath and persistent cough.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: facial numbness and tingling, disappear in 24 hours
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Hypoaesthesia, Neurological examination
Clinical narrative: 45-60 minutes post vaccination, patient experienced right eye twitching continuous for a few hours, then intermittent x 24 hrs; now resolved 12 hours post vaccination, patient experienced right ear/jaw numbness that lasted up to 36hrs 36 hrs post vaccination, the numbness is spreading to the right cheek no affect in muscle function, just numb pt seen at urgent care facility 12/23 @~0830 and prednisone initiated
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site haemorrhage, Injection site pain, Limb discomfort, Loss of personal independence in daily activities, Muscular weakness
Clinical narrative: Tingling down right arm into right hand, spread to left arm and hand. Stiffness in neck. After an hour progressed into muscle weakness in both forearms, more noticeable in the right arm. Best described as lactic acid buildup feel in forearm-had trouble lifting/pulling door handles. Has subsided over a day, no general soreness in both arms/ neck. Injection site has developed noticeable pain/soreness, somewhat like a tetanus shot . There was a fair amount of blood at the injection site (not typical for me), and the administration of the shot was a touch high in the arm.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Paraesthesia, Product administered at inappropriate site
Clinical narrative: Tingling down right arm into right hand, spread to left arm and hand. Stiffness in neck. After an hour progressed into muscle weakness in both forearms, more noticeable in the right arm. Best described as lactic acid buildup feel in forearm-had trouble lifting/pulling door handles. Has subsided over a day, no general soreness in both arms/ neck. Injection site has developed noticeable pain/soreness, somewhat like a tetanus shot . There was a fair amount of blood at the injection site (not typical for me), and the administration of the shot was a touch high in the arm.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Paraesthesia
Clinical narrative: Lightheadedness, tingling extremities and dizziness
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Mobility decreased, Peripheral swelling
Clinical narrative: Extensive limb swelling and erythema of left upper lateral/posterior arm down to elbow without limitation to movement of joints (examined in clinic 21 DEC 2020 in the AM). No treatment had been initiated at that time. Recommended treatment with cool compresses and ibuprofen moving forward.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hyperhidrosis
Clinical narrative: Fatigue, sweaty, and dizziness
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Staff member started to feel fatigue and chills the evening he received the vaccine. Symptoms continued the following day and a half. Fever was as high as 101.4. He had COVID nine months ago. Symptoms have resolved.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Flushing, Headache, Nausea
Clinical narrative: Nausea, fatigue, headache, flushing
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: PATIENT STATES HANDS TINGLING BUT WENT AWAY PATIENT HAD NOT INTERVENTIONS OR PROLONGED OBSERVATION
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral
Clinical narrative: Lip and tongue tingling
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Lip swelling, Paraesthesia oral
Clinical narrative: Lip and tongue tingling
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: TINGLING LIPS REPORTED
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Soreness at injection site, Fever at 99.8 degrees F. Body Aches, headache
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Decreased appetite, Fatigue, Headache, Myalgia
Clinical narrative: 12/21/2020: fatigue, muscle ache 12/22/2020: fatigue, muscle ache, headache, fever, loss of appetite, nausea, and sore throat.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: 12/21/2020: fatigue, muscle ache 12/22/2020: fatigue, muscle ache, headache, fever, loss of appetite, nausea, and sore throat.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Flushing
Clinical narrative: Patient became flushed, chest tightness and felt winded. BP was 130/70 and 02 saturation was 100%. Patient had not tongue swelling, previous reaction to a vaccine, medication or food and no shortness of breath. Patient was placed on gurney for 30 minutes and had no further symptoms after this time.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Discomfort, Injection site erythema, Injection site haematoma, Injection site pain, Injection site swelling
Clinical narrative: Patient was given IM injection into left deltoid. Patient seemed to tolerate injection well, bandage placed on site. Within 2 minutes, bandage was saturated with blood, and soaked through patient's shirt. RN applied pressure as well as new bandage. It was then noted patient had 2 hives at injection site and redness. Patient also complained of pain. Patient had no respiratory distress. Patient observed, and when guardian felt comfortable took patient home. Guardian called 3 hours later to say patient was still complaining a lot of discomfort, site was swollen and red.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site urticaria
Clinical narrative: Patient was given IM injection into left deltoid. Patient seemed to tolerate injection well, bandage placed on site. Within 2 minutes, bandage was saturated with blood, and soaked through patient's shirt. RN applied pressure as well as new bandage. It was then noted patient had 2 hives at injection site and redness. Patient also complained of pain. Patient had no respiratory distress. Patient observed, and when guardian felt comfortable took patient home. Guardian called 3 hours later to say patient was still complaining a lot of discomfort, site was swollen and red.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Pain, Pyrexia
Clinical narrative: Fatigue, diarrhea, whole body aches, fever
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: Bad headache and sore on injection site
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle tightness, Pharyngeal paraesthesia
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine  within 1-2 post vaccine administration started to experience tingling of throat (needle like feeling and some neck tightness). Symptoms started to disappear after 10 min and went completely away after 30 min
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal paraesthesia, Throat tightness
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine  within 1-2 post vaccine administration started to experience tingling of throat (needle like feeling and some neck tightness). Symptoms started to disappear after 10 min and went completely away after 30 min
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hypersensitivity, Injection site erythema
Clinical narrative: Injection site raised, firm area (size of quarter); redness but no streaking; extreme tiredness, chills, headache, neck pain. Patient went to walk in clinic and provider believed her to be having a localized allergic reaction to the COVID vaccine. She was given a steroid injection, and started on oral steroids.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site swelling, Local reaction, Neck pain
Clinical narrative: Injection site raised, firm area (size of quarter); redness but no streaking; extreme tiredness, chills, headache, neck pain. Patient went to walk in clinic and provider believed her to be having a localized allergic reaction to the COVID vaccine. She was given a steroid injection, and started on oral steroids.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: 1 hr post administration patient developed urticaria, pruritus
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: pt believed she was receiving pneumococcal vaccine once every 3 years; This spontaneous report as received from a lawyer refers to a currently 69-year-old female patient. Patient was a non-smoker.      It was reported that patient believed she was receiving pneumococcal vaccine (manufacturer unknown) once every 3 years (dates of administration, lot#, expiration date, dose, route of administration and anatomical location were not reported).  This is one of 2 reports concerning the same patient.; Sender's Comments:  US-009507513-2003USA009266:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Injection site pain, Mouth ulceration
Clinical narrative: injection site soreness; myalgias; chills; fatigue; nausea; loss of appetite; enanthem (2 oral ulcers); enanthem (2 oral ulcers); This is a spontaneous report from a non-contactable consumer (patient). A 39-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EH9899 and expiry date unknown) via an unspecified route of administration at the left arm on 18Dec2020 12:30PM at a single dose for COVID-19 immunization and monascus purpureus (RED YEAST RICE), via an unspecified route of administration from an unspecified date to an unspecified date at an unknown dose and frequency as supplementation therapy. The patient's medical history included elevated LDL cholesterol and supplementation therapy, both from an unknown date and unknown if ongoing. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient only received red yeast rice supplements within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that on 19Dec2020, the patient experienced injection site soreness, myalgias, chills, fatigue, nausea, loss of appetite, and enanthem (2 oral ulcers). No therapeutic measures were done in response to the events. Outcome of the events was recovering. The events were assessed as Non-serious.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: injection site soreness; myalgias; chills; fatigue; nausea; loss of appetite; enanthem (2 oral ulcers); enanthem (2 oral ulcers); This is a spontaneous report from a non-contactable consumer (patient). A 39-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EH9899 and expiry date unknown) via an unspecified route of administration at the left arm on 18Dec2020 12:30PM at a single dose for COVID-19 immunization and monascus purpureus (RED YEAST RICE), via an unspecified route of administration from an unspecified date to an unspecified date at an unknown dose and frequency as supplementation therapy. The patient's medical history included elevated LDL cholesterol and supplementation therapy, both from an unknown date and unknown if ongoing. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient only received red yeast rice supplements within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that on 19Dec2020, the patient experienced injection site soreness, myalgias, chills, fatigue, nausea, loss of appetite, and enanthem (2 oral ulcers). No therapeutic measures were done in response to the events. Outcome of the events was recovering. The events were assessed as Non-serious.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: fever; chills; malaise; This is a spontaneous report from a contactable physician (Patient)  via Pfizer-sponsored program.   A 27 year-old-male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced fever and chills on 18Dec2020 (in the night); the patient also experienced malaise throughout the weekend (in Dec2020). Patient had vaccine on 18Dec2020 and was still having symptoms 3 days later. As of 20Dec2020, patient stated he was feeling better but wanted to know if he should get tested or did the vaccine cause these symptoms. Final outcome of the events was reported as unknown. Information on the lot/batch number has been requested.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Malaise, Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: fever; chills; malaise; This is a spontaneous report from a contactable physician (Patient)  via Pfizer-sponsored program.   A 27 year-old-male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced fever and chills on 18Dec2020 (in the night); the patient also experienced malaise throughout the weekend (in Dec2020). Patient had vaccine on 18Dec2020 and was still having symptoms 3 days later. As of 20Dec2020, patient stated he was feeling better but wanted to know if he should get tested or did the vaccine cause these symptoms. Final outcome of the events was reported as unknown. Information on the lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein, Dysuria, Full blood count
Clinical narrative: Experiencing burning while urinating; This is a spontaneous report from a contactable consumer (patient who is Nursing assistant).  This 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EK5730), via an unspecified route of administration, on 19Dec2020 approximately at 10:00 AM (age at vaccination 56-years-old) at single dose for COVID-19 immunisation. Medical history included blood pressure. Concomitant medications included losartan for blood pressure and colecalciferol (VITAMIN D). The patient experienced burning while urinating on 19Dec2020 afternoon after she came home and on 20Dec2020 morning too. About treatment consumer stated: "Not really, long time ago I had that but yesterday I did like oh".  The patient had complete blood count (CBC) and C-reactive protein (CRP) test, results are unknown. Outcome was not recovered. Next shot is due on 09Jan2021.
Age: 13.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: expired dose of IPOL was administered to a patient, no AE; Initial information received on 11-Dec-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to case 2020SA357481 (same reporter).  This case involves a 13 years old male patient who was vaccinated with an expired 0.5 ml dose of IPV (VERO) [IPOL](lot P1F49M and expiration date :30-Nov-2020) via intramuscular route in the right deltoid for prophylactic vaccination on 03-Dec-2020 (expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (same day latency).   No adverse event reported at the time of reporting.   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: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Increased heart rate up to the 115-120s for 3 hours - self reported
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Sore arm at injection site night of vaccine and next day. Then resolved (without taking any acetaminophen).
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Arthralgia, Chest pain, Fatigue
Clinical narrative: I had the covid 19 virus in March 2020.  Actually, I still have loss of taste and smell.  When I received the vaccine on 12/21/2020, I immediately felt a burning sensation at the injection site and in my chest.  A headache developed 5 minutes after the vaccine.  I began to experience fatigue, nausea, muscle aches and joint pain.  I have been treating myself with Tylenol and Ondansetron.  I am still experiencing these side effects today (12/23/2020)
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Immediate post-injection reaction, Injection site pain, Myalgia, Nausea
Clinical narrative: I had the covid 19 virus in March 2020.  Actually, I still have loss of taste and smell.  When I received the vaccine on 12/21/2020, I immediately felt a burning sensation at the injection site and in my chest.  A headache developed 5 minutes after the vaccine.  I began to experience fatigue, nausea, muscle aches and joint pain.  I have been treating myself with Tylenol and Ondansetron.  I am still experiencing these side effects today (12/23/2020)
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Paraesthesia
Clinical narrative: 11 am started noticing tingling in Right side of face. Then redness on ry neck below jaw and  tingling on left side of face and left side of body. Lasting for 1 hour
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine with aura, Nausea, SARS-CoV-2 test negative
Clinical narrative: Migraine headache with nausea and aura, treated with Toradol 60 MG IM 12/23/20 at 13:35.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: Severe redness & swelling 4.5" below the injection site. Later in the evening developed muscle pain, severe headache, shivering, fever & night sweats. Headache resolved by 10:00 am this morning. Muscle pain as well as swelling  & pain below below the injection site persists.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Night sweats, Pyrexia
Clinical narrative: Severe redness & swelling 4.5" below the injection site. Later in the evening developed muscle pain, severe headache, shivering, fever & night sweats. Headache resolved by 10:00 am this morning. Muscle pain as well as swelling  & pain below below the injection site persists.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Nausea
Clinical narrative: pt became lightheaded and nauseated.  Elevated feet and given ice pack for neck.  Pulse 70, resp 16. rested for 30 minutes, feeling much better - able to ambulate without difficulty.  States she just feels a little off.  Husband came to take her home.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Condition aggravated, Injection site rash, Pruritus, Sleep disorder
Clinical narrative: After she waited for 30 minutes after receiving vaccine she stated that she had generalized itching and 2 small hives on her right arm. She said it started about 3 mins after receiving the vaccine.  She was given 25mg of Benadryl syrup po. She stayed at facility another 30 minutes before being cleared to leave after she said the itching was better and no further hives formed.  12/23/20 -9:56am She was contacted by phone. She said she woke in the night and felt like "asthma" and had a rash at the site. She took another 25mg of Benadryl. She took another dose of Benadryl at 06:00am. As of this time, 9:56am, she states, no shortness of breath, no more rash at site, and the itching has subsided. She will follow up as needed.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: After she waited for 30 minutes after receiving vaccine she stated that she had generalized itching and 2 small hives on her right arm. She said it started about 3 mins after receiving the vaccine.  She was given 25mg of Benadryl syrup po. She stayed at facility another 30 minutes before being cleared to leave after she said the itching was better and no further hives formed.  12/23/20 -9:56am She was contacted by phone. She said she woke in the night and felt like "asthma" and had a rash at the site. She took another 25mg of Benadryl. She took another dose of Benadryl at 06:00am. As of this time, 9:56am, she states, no shortness of breath, no more rash at site, and the itching has subsided. She will follow up as needed.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pruritus
Clinical narrative: I was itchy only to find out it was Shingles
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pruritus, Rash, Scab, Urticaria
Clinical narrative: 1049: CG called OH and advised she received the COVID19 vaccine yesterday and woke up this morning at 0630 with a rash to her right chest and right hand, and complains of fatigue. CG denies any SOB or any other symptoms at this time. CG advised she has a history of COPD, Asthma, and granuloma disease. Advised she spoke with her Oncologist about receibving the vaccine who did not have any concerns but also voiced that she did not speak to her PCP. Occ. Health advised CG that she be seen by urgent care or PCP for current symptoms and to go to the ER if symptoms worsen or she becomes SOB.  1106: Called CG to see if she was able to touch base with PCP, advised that she has a call out to her and messaged her PCP. CG states that the rash has remained the same since this morning and that it does not itch anymore. Again advised CG if worsens to go to Urgent care or ER. CG verbalizes understanding. Will follow-up with CG later today. 1448: Called CG states the hives are mostly gone, she took some benadryl and feels back to her normal self, just has some scabs from where she scratched herself. CG states her PCP responded back to you that if she felt necessary should go to the urgent care or do a virtual appointment. Cargiver declined and states she is feeling a lot better. Advised CG to call OH with any changes and to go to the ER or Urgent care for any emergency symptoms. CG verbalized understanding.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Gingival pain, Gingival swelling, Lip pain, Lip swelling
Clinical narrative: 30 minutes after vaccination pain occured on my left upper gums, left upper lip and into my left chee with swelling in the same locations, that have not resolved
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: 30 minutes after vaccination pain occured on my left upper gums, left upper lip and into my left chee with swelling in the same locations, that have not resolved
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: EXTREME BILATERAL ITCHING ON BOTH ARMS THROUGHOUT
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Skin warm, Sleep disorder, Tenderness
Clinical narrative: The day after receiving the vaccine, the arm that I got the vaccine in was in severe pain. I would say 7/10 pain. Anything even slightly brushing against it was very painful. It was a little red and hot to the touch. I woke up multiple times through the night because of the pain. I did NOT take anything for it. By the following morning it was just sore, like how you normally would feel after a vaccine.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Herpes zoster, Rash
Clinical narrative: 11am on the 20th I noticed pain on my back torso and it came around to the left of my abdomen and was told it was textbook shingles rash and was prescribed valacyclovir 1gram 3x daily for one week, the pain is now mild and I can treat it with tylenol and I've only had to take it once, the rash is still there but it's not spreading I started the medication at 3pm after seeing the dr
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dysphagia, Flushing, Paraesthesia oral, Pruritus
Clinical narrative: 25-30 min post injection patient reported feeling itchy and became flushed.   Reported mouth tingling and difficulty swallowing.   No difficulty breathing.   Monitored the patient, sats were wnl BP was elevated.   Cool pack placed on forehead, and patient took oral benedryl.   After about 20 minutes color and BP had normalized, itching and tingling resolved.   Patient ate and drank and felt well enough to leave on her own.    No further issues.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: after vaccination client had a weird taste in back of throat during 15 minute wait time. Had client wait additional  15 minutes and still had a weird taste in mouth.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Flushing, Injection site pain, Palpitations
Clinical narrative: First 30 min post-vaccine: flushing and lightheaded, self limiting. 1.5 hours post-vaccine: vertigo x10 minutes, palpitations, chest tightness. Palpitations were brief and at rest. BP 172/110, HR 95, O2 Sat 99% on RA. 2.5 hours post-vaccine: chest tightness has remained constant with mild restrictive sensation on full inhale, vertigo returned but briefer in duration, BP 173/100, HR 85, Temperature 98.5F, O2 Sat 97% with decrease during conversation. 3 hours post-vaccine: lightheaded with constant chest tightness, BP 168/110, HR 88, O2 Sat 98% on RA, 6 hours post-vaccine: symptoms resolved, BP 148/100, injection site burns and sore to touch.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: First 30 min post-vaccine: flushing and lightheaded, self limiting. 1.5 hours post-vaccine: vertigo x10 minutes, palpitations, chest tightness. Palpitations were brief and at rest. BP 172/110, HR 95, O2 Sat 99% on RA. 2.5 hours post-vaccine: chest tightness has remained constant with mild restrictive sensation on full inhale, vertigo returned but briefer in duration, BP 173/100, HR 85, Temperature 98.5F, O2 Sat 97% with decrease during conversation. 3 hours post-vaccine: lightheaded with constant chest tightness, BP 168/110, HR 88, O2 Sat 98% on RA, 6 hours post-vaccine: symptoms resolved, BP 148/100, injection site burns and sore to touch.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Dizziness, Feeling hot
Clinical narrative: Progress Notes     12/22/2020       Subjective Patient is a 46 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination.    She denied any history of previous adverse reactions to vaccines.   Pt has h/o hypothyroidism on LT4- last lab a few months ago Started feeling lightheaded and warm Doing a temp check   135/94- repeat BP check Pulse between 72-90s on rechecked     Blood sugar was just checked and normal at 76--repeat also normal at 86   She is eating a snack and having some water.    She was given the Pfizer vaccination in the right deltoid muscle.   She said she has a h/o vasovagal episodes with shots, mammograms, etc.    During her 15 minute waiting period after the injection, the patient began to experience dizziness.  She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including rapid progression of symptoms, vomiting, abdominal pain, hypotension, dysrhythmia, chest pain and collapse.        Objective     Physical Exam Constitutional:      Appearance: Normal appearance.  HENT:     Head: Normocephalic and atraumatic.     Nose: Nose normal.     Mouth/Throat:     Mouth: Mucous membranes are dry.     Pharynx: Oropharynx is clear.  Eyes:     Extraocular Movements: Extraocular movements intact.     Conjunctiva/sclera: Conjunctivae normal.     Pupils: Pupils are equal, round, and reactive to light.  Neck:     Musculoskeletal: Normal range of motion and neck supple.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Pulses: Normal pulses.     Heart sounds: Normal heart sounds.  Pulmonary:     Effort: Pulmonary effort is normal.     Breath sounds: Normal breath sounds.  Abdominal:     General: Abdomen is flat. Bowel sounds are normal.     Palpations: Abdomen is soft.  Musculoskeletal: Normal range of motion.  Skin:    General: Skin is warm and dry.  Neurological:     General: No focal deficit present.     Mental Status: She is alert and oriented to person, place, and time. Mental status is at baseline.  Psychiatric:        Mood and Affect: Mood normal.        Behavior: Behavior normal.        Thought Content: Thought content normal.        Judgment: Judgment normal.         Assessment/Plan  Treatment included: rest, snack. Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP.     Discharge time 5:51pm        12/22/2020 5:19 PM