chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Hyperhidrosis, Nausea, Pallor, Paraesthesia, Unresponsive to stimuli
Clinical narrative: Flu vaccine and Tdap vaccine administered RN and Nursing Student. Within 30 seconds the pt stated that she was feeling dizzy and that her legs were feeling tingly. I helped the pt to elevate her legs and reclined her head slightly. on the exam chair. Pt leaned forward with eyes closed. Pt was slumped over and had some loss of color in the face and lips. I helped the pt to sit up while saying her name. No response from pt. Pt began to make grunting sounds, and her body appeared to be jerking. I was beside the pt to prevent her from falling. The pt appeared to be sweating. Her shirt was wet on the front and back. I heard flatulation sounds. This lasted for approximately 2 minutes. RN called for help. Two other RNs came to the room. Nurse was saying the pt's naame, and another nurse was holding an alcohol pad to the pt's nose. The pt's head was reclined slightly. I left the room to get the crash cart, and I notified, FNP about the situation. I arrived back to the pt's room with the crash cart, and FNP assessed the pt. At this time, the pt was alert and oriented. The other jerking  and grunting had subsided. She was laying on her side holding an emesis bag. Pt stated that she was feeling nauseated. RN got the vials machine and checked the pt's vital signs starting at approximately 0920. The pt's BP was 97/65 ans trending up to 135/63 after 3 checks per RN. She instructed me to check again in 5 minutes. The pt stated that she was feeling better. I checked her VS again. Her BP had dropped to 78/52, and she stated that she was feeling hot, nauseated, and dizzy. I held an ice pack covered with a towel on her forehead. She stated that she did not eat anything today. She was given an orange juice and peanut butter crackers. She drank a few sips of juice, and she ate 2 crackers. The vital signs were checked every 5-10 minutes until approximately 1005. BP was trending up. Pt denied feeling dizzy, sweaty, nauseated, and hot. When asked how she felt, she stated that she felt good at this time. Pt stated that she did not need an ambulance to be called. Pt stood up slowly and walked. She stated that she was still feeling well, and that she did not have any concerns or abnormal symptoms. I encouraged the pt to notify her PCP of this occurrence.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Constipation, Gait inability, Headache
Clinical narrative: Woke at 32hrs with severe pain in Rt hip joint and Rt knee joint. later in day rt leg was numb, unable to bear weight, go up stairs without assist or sleep. Next day #3, severe pain in Rt hip, Rt knee and femur. Not responding to  Motrin 800mg Q6-8hrs, Tylenol 1gm Q6-8 hours. Day #4 pain now radiating down rt leg through both joints and into Rt calf. Now Monday- called PCP, advised symptoms and would be starting perocets for 2 days of severe pain post vaccine. Also took ASA 325mg for blood clot risk know with virus even through pain was hip to ankle now (not ascending but descending) Percocet Q6hours without improvement but could sit and sleep with pain (dulled brain response to pain). Day #5- leg completely numb, pain now following sciatic nerve, stopped meds as no improvement and developed headaches, stomach aches and constipation from meds. Day#6 Pain severe in am, from hip to ankle- leg and heal of Rt foot numb. Today  #7 pain on awaking, Rt hip all along sciatic nerve to foot which remains numb in heel.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Sleep disorder
Clinical narrative: Woke at 32hrs with severe pain in Rt hip joint and Rt knee joint. later in day rt leg was numb, unable to bear weight, go up stairs without assist or sleep. Next day #3, severe pain in Rt hip, Rt knee and femur. Not responding to  Motrin 800mg Q6-8hrs, Tylenol 1gm Q6-8 hours. Day #4 pain now radiating down rt leg through both joints and into Rt calf. Now Monday- called PCP, advised symptoms and would be starting perocets for 2 days of severe pain post vaccine. Also took ASA 325mg for blood clot risk know with virus even through pain was hip to ankle now (not ascending but descending) Percocet Q6hours without improvement but could sit and sleep with pain (dulled brain response to pain). Day #5- leg completely numb, pain now following sciatic nerve, stopped meds as no improvement and developed headaches, stomach aches and constipation from meds. Day#6 Pain severe in am, from hip to ankle- leg and heal of Rt foot numb. Today  #7 pain on awaking, Rt hip all along sciatic nerve to foot which remains numb in heel.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Muscle soreness,  swelling,  and redness at site area. Second day of the issue.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Injection site warmth, Rash pruritic
Clinical narrative: One week after injection, developed warm, itchy rash at site.   About size of a baseball.   Applying Cortisone  cream.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Vaccine was administered at 8:03 AM. Patient was monitored at clinic until 8:33 AM at which time the patient left the clinic site. At 10:56 AM, the patient reported back to the clinic with concerns over hives on left arm and face. At 10:57 AM, patient was given 50 mg oral diphenhydramine.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Appendicectomy, Appendicitis
Clinical narrative: Developed appendicitis that led to appendectomy
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Fever, fatigue, headache
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pain in extremity
Clinical narrative: Patient had bruising and arm pain which lasted about 10-12 days post vaccination. It resolved on its own without treatment
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysgeusia, Fatigue, Feeling abnormal, Head discomfort
Clinical narrative: Immediately could taste the vaccine. Sore, Tired, pain at injection site.  No big deal .  My brain was foggy - impaired - felt dizzy - or unbalanced  - next day missed work .  My head felt like in a vice.  Terrible. pain.  This was really scary - I did not know if I was so tired - it was effecting me this way - but honestly I was worried about having a stroke or something similar.  I had the shot on Tuesday morning - felt impaired somewhat on Tuesday day - really unwell - but Wednesday - was afraid to drive - as felt mentally impaired.  Friday today - I  am taking 4000 milligrams of Tylenol per day and it is helping.  I am much better today.   I hope I will be all better tomorrow.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired driving ability, Impaired work ability, Injection site pain, Malaise, Mental impairment
Clinical narrative: Immediately could taste the vaccine. Sore, Tired, pain at injection site.  No big deal .  My brain was foggy - impaired - felt dizzy - or unbalanced  - next day missed work .  My head felt like in a vice.  Terrible. pain.  This was really scary - I did not know if I was so tired - it was effecting me this way - but honestly I was worried about having a stroke or something similar.  I had the shot on Tuesday morning - felt impaired somewhat on Tuesday day - really unwell - but Wednesday - was afraid to drive - as felt mentally impaired.  Friday today - I  am taking 4000 milligrams of Tylenol per day and it is helping.  I am much better today.   I hope I will be all better tomorrow.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Immediately could taste the vaccine. Sore, Tired, pain at injection site.  No big deal .  My brain was foggy - impaired - felt dizzy - or unbalanced  - next day missed work .  My head felt like in a vice.  Terrible. pain.  This was really scary - I did not know if I was so tired - it was effecting me this way - but honestly I was worried about having a stroke or something similar.  I had the shot on Tuesday morning - felt impaired somewhat on Tuesday day - really unwell - but Wednesday - was afraid to drive - as felt mentally impaired.  Friday today - I  am taking 4000 milligrams of Tylenol per day and it is helping.  I am much better today.   I hope I will be all better tomorrow.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: It is unknown if the decedent had any side effects.  Patient died on 3/11/2021.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Lymphadenopathy
Clinical narrative: My left glad lymph node swelled up, pretty tight and large.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: The nurse put a Band-aid on the injection site before I could tell her I am sometimes allergic. The second day I developed two little square rashes where the Band-aid adhesive touched my skin. Other than that, I had no immediate effects. About February 18, I noticed my arm had a large pinkish rash about 2" x 4" and was quite itchy. I looked on the internet to see what side effects I could find. I saw information about "Covid Arm," and I'm sure this is what I experienced. I followed the advice I saw about Covid Arm. I used a hydrocortizone cream on the rash until it cleared up about March 1. I took Claritin for a couple of days to help with the itching. I took a photo on February 19. When I returned to get my second injection, I asked the nurse to give me the vaccine in my right arm. I am hopeful I won't develop the rash on this arm, but time will tell.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Constipation, Diarrhoea, Fatigue, SARS-CoV-2 test negative
Clinical narrative: On 3/10/2021 the patient presented to the ED with fatigue and diarrhea. The patient had been constipated and then started taking magnesium citrate and Colace. Since starting the laxatives the patient had been experiencing diarrhea. Once at the hospital, the patient was routinely tested for COVID-19. She had one COVID antigen that was positive and one negative, and the COVID PCR negative. Chest xray shows no pneumonia and he WBC was 11,000. Reason for admission: diarrhea and weakness.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, White blood cell count increased
Clinical narrative: On 3/10/2021 the patient presented to the ED with fatigue and diarrhea. The patient had been constipated and then started taking magnesium citrate and Colace. Since starting the laxatives the patient had been experiencing diarrhea. Once at the hospital, the patient was routinely tested for COVID-19. She had one COVID antigen that was positive and one negative, and the COVID PCR negative. Chest xray shows no pneumonia and he WBC was 11,000. Reason for admission: diarrhea and weakness.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Cognitive disorder, Loss of personal independence in daily activities, Pain in extremity, Pyrexia, Seizure
Clinical narrative: Got vaccine and 2-3 hours afterwards, was at home, and had a seizure which she has not had in a number of years.  She has a routine that she knows when she has a seizure coming on, she immediately went to the floor, pushed things away that she may hit.  When she felt like she could get to a safe place she grabbed her phone and got there, she was able to move enough to move into the bed, wrap in the covers and if it was a tonic clonic she would not be ideally harmed.  Then had immediate sleep for over 12 hours, took her medicine in the middle of the night when she awakened but suffered the next day due to missing her dose due to sleeping, which affected her thought processes the next day and also with the brain damage that she already has.  She did report to the epilepsy center and also to her PCP.  The evening she again had another seizure, felt the effects coming on again repeated the process that she did the day before.  She did have the 12 hour sleep after that one as well.   She has also had pain in her thighs, hamstrings, feverish feeling.   She is still suffering the effects from the seizure.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: Got vaccine and 2-3 hours afterwards, was at home, and had a seizure which she has not had in a number of years.  She has a routine that she knows when she has a seizure coming on, she immediately went to the floor, pushed things away that she may hit.  When she felt like she could get to a safe place she grabbed her phone and got there, she was able to move enough to move into the bed, wrap in the covers and if it was a tonic clonic she would not be ideally harmed.  Then had immediate sleep for over 12 hours, took her medicine in the middle of the night when she awakened but suffered the next day due to missing her dose due to sleeping, which affected her thought processes the next day and also with the brain damage that she already has.  She did report to the epilepsy center and also to her PCP.  The evening she again had another seizure, felt the effects coming on again repeated the process that she did the day before.  She did have the 12 hour sleep after that one as well.   She has also had pain in her thighs, hamstrings, feverish feeling.   She is still suffering the effects from the seizure.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Swollen tongue
Clinical narrative: My tongue swelled up on the right side.  Quite large, to where I couldn't lay on my back and breath easily, I needed to stay on my side.   It began to subside about 4 hours later with no treatment.  I did not see an wound that would cause this.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site paraesthesia, Paraesthesia
Clinical narrative: Patient stated that starting 1 week post vaccine, she experienced numbness & tingling starting at injection site, and went down to thumb.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Patient reports experiencing diarrhea the morning after receiving his vaccine. He has taken OTC Immodium A-D which relieves his symptoms.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Gingival bleeding, Pharyngeal swelling, Retching, Throat tightness
Clinical narrative: Throat swelled within 25 minutes of injection. Gagging, coughing, swollen throat. Felt like throat closing down and chocking on fur ball. Returned to nurses station. Checked by nurse, doctor and paramedics called. Gave Benadryl liquid. Paramedics recorded blood pressure 143/110, inserted IV for medications to treat choking. Taken to nearby ER facility and treated with additional Benadryl and Prednisone. Patient held for observation for approximate 2 hours, while vitals monitored and chocking ceased.   Later in the evening, patient experienced gums bleeding. Rinsed with salt water and brushing.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Dyspnoea
Clinical narrative: SHORTNESS OF BREATH
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Feeling tired
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Chills, Fatigue, Heart rate increased
Clinical narrative: I had a slight anxiety feeling like fast heartbeat during my 15 minute wait time but not alarming. I left and continued my day but felt increasingly itchy and hours later developed a few hives.  I took a Zyrtec and after a few more hours it all went away,  For the next few days I had tiredness, joint pain and some chills. Completely better after a week.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: I had a slight anxiety feeling like fast heartbeat during my 15 minute wait time but not alarming. I left and continued my day but felt increasingly itchy and hours later developed a few hives.  I took a Zyrtec and after a few more hours it all went away,  For the next few days I had tiredness, joint pain and some chills. Completely better after a week.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site inflammation, Injection site pruritus, Injection site warmth
Clinical narrative: slight inflammation in the arm where vaccine was give, some pink, itchiness, and hot
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: Received second dose of vaccine on 2/19.  presented to this  ED on 2/20/21 with generalized weakness.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Hyperhidrosis, Unresponsive to stimuli
Clinical narrative: Once in the monitoring area, the patient (who is a Facility staff member) was sweating profusely, had increased BP, was unresponsive (but was conscious). She was tended to by the Facility Director of Nursing. The facility called 911, EMT's took pt to hospital. She was released after 2 hours and was back at work the next day.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness to arm and warmth at injection site
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Rash papular
Clinical narrative: Received vaccine on 3/2/21. On 3/11/21, noticed my right arm (at injection site) had a raised rash, bumpy and slightly swollen and red. No itching or pain. Applied Hydrocortisons cream 1mg. Today, 3/12 not bumpy but slightly warm to touch and slightly red. I thought that was strange since it's been 9 days since I had first vaccine! Due for next vaccine on 3/30. What do you advise?
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Unauthorized age group (17 years old) received Moderna instead of Pfizer.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation
Clinical narrative: Agitation
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased
Clinical narrative: Lightheaded, elevated HR, evaluated by EMS-cleared
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Fatigue, Pain
Clinical narrative: Low grade fever (99.2-100.3.)  Body aches Weakness Fatigue Took one 500 mg Tylenol approximately 18 hrs after fever started. Symptoms lasted approximately 24-30 hrs.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Tremor
Clinical narrative: Symptoms: Nauseated and shaking hand Treatment: education, water and snack, had patient wait an extra 15 min. When she left she stated she felt great.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy, Dermatitis psoriasiform, Eczema, Eosinophil count, Hepatitis C test negative
Clinical narrative: I first started with small rash around my breast. A few weeks later on 2.14.21, I noticed a large amount of small rashes all over both my breast. Then a few days after that, I had more rashes around my trunk and inner thighs then went to my under arms, back, legs, top of my feet, thighs  and abdomen. A lot of the rashes are starting to dry out, however I am still getting new ones each day. I had it biopsied by the dermatologist .
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Liver function test normal, Rash
Clinical narrative: I first started with small rash around my breast. A few weeks later on 2.14.21, I noticed a large amount of small rashes all over both my breast. Then a few days after that, I had more rashes around my trunk and inner thighs then went to my under arms, back, legs, top of my feet, thighs  and abdomen. A lot of the rashes are starting to dry out, however I am still getting new ones each day. I had it biopsied by the dermatologist .
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray normal, Chest pain, Diarrhoea, Electrocardiogram normal, Headache
Clinical narrative: Sever diarrhea, headache, chest pains, upper respiratory congestion
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Upper respiratory tract congestion
Clinical narrative: Sever diarrhea, headache, chest pains, upper respiratory congestion
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Injection site erythema, Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Additional Details: SHOT given on 03.08.21 rash developed 03.10.21 on arms.  on 03.11.21 progressed to legs, and chest 03.12.21 pt states itching worse, states she feels a little bit of labored breathing. advised to go to md, er, now. offered to call ambulance pt states not necessarey. advised her not to get 2nd shot unless it is in hospital setting and physician authorized. stressed she must go to md now
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Pruritus, Rash
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Additional Details: SHOT given on 03.08.21 rash developed 03.10.21 on arms.  on 03.11.21 progressed to legs, and chest 03.12.21 pt states itching worse, states she feels a little bit of labored breathing. advised to go to md, er, now. offered to call ambulance pt states not necessarey. advised her not to get 2nd shot unless it is in hospital setting and physician authorized. stressed she must go to md now
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Thrombosis in popliteal vein
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Loss of consciousness, Tremor
Clinical narrative: On 03/12/21, 39 yo M with No Known Allergies presented to Drive Up Covid Vaccine clinic. At 0922, pt was administered COVID-19 (Janssen) Vaccine 0.5 mL in left deltoid (Lot #1802070; NDC: 59676-580-15; Exp: 5/25/2021). 2 minutes after injection, pt became diaphoretic with tremors and loss of consciousness. Pt placed in reclined position, pulse present and became responsive and verbal within 30 seconds. Ice pack applied and EMS called. Pt was transported to a local hospital for follow up care. No additional information available.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anti-thyroid antibody, Antinuclear antibody, Blood thyroid stimulating hormone, Dysphagia, Full blood count
Clinical narrative: Post first vaccine L axillary lymphadenopathy.  Post #2-L sub acute thyroiditis with difficulty swallowing, pain and  significant lymph node swelling  that became worse over a week.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Metabolic function test, Thyroiditis subacute, Thyroxine free
Clinical narrative: Post first vaccine L axillary lymphadenopathy.  Post #2-L sub acute thyroiditis with difficulty swallowing, pain and  significant lymph node swelling  that became worse over a week.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound thyroid
Clinical narrative: Post first vaccine L axillary lymphadenopathy.  Post #2-L sub acute thyroiditis with difficulty swallowing, pain and  significant lymph node swelling  that became worse over a week.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lip swelling, Peripheral swelling, Pruritus, Swelling of eyelid
Clinical narrative: Within 5 hours, patient was awakened from her nap but found that her eyes were swollen shut, upper lip was swollen and her gums itched.  Her head was hurting which is what awakened her.  She went and looked in the mirror, she immediately took a Benadryl 25 mg oral gel cap.  Within 20 minutes, the swelling and itching started to improve.  The symptoms resolved after taking the Benadryl.  The next day, she went to work.  She took another Benadryl at 10 AM on Friday, slept all day.  She ran errands on Saturday, took a Benadryl with her just in case.  She also carried an Epi pen.  Her feet began to swell, her hands swelled and she started itching all over.  Her throat began to close.  She took a Benadryl immediately (this is day 3).  The symptoms did resolve.   She returned home.  On day four, she had some nausea.  On day five (Monday), she went to work and her tonsils started throbbing.  She ran her bus driver route.  She was itching all over again.  She took another Benadryl . She called Dr. on day 5 after vaccination because of the recurring symptoms.  She also called her allergist.  She had an appointment with her allergist on day 6.  Family Doctor also called back on Day 5 and called a prescription in for Prednisone.  She did not start the Prednisone.  She did see the allergist on day 6. The allergist thinks her reaction might have been due to the preservative in the Moderna product.  It was the only ingredient in both the flu shot (7 years ago) and the Moderna contents.  She advised her to take the Prednisone dose pack (as prescribed by family doctor) to over-ride and she upped her Zyrtec to bid.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Throat tightness
Clinical narrative: Within 5 hours, patient was awakened from her nap but found that her eyes were swollen shut, upper lip was swollen and her gums itched.  Her head was hurting which is what awakened her.  She went and looked in the mirror, she immediately took a Benadryl 25 mg oral gel cap.  Within 20 minutes, the swelling and itching started to improve.  The symptoms resolved after taking the Benadryl.  The next day, she went to work.  She took another Benadryl at 10 AM on Friday, slept all day.  She ran errands on Saturday, took a Benadryl with her just in case.  She also carried an Epi pen.  Her feet began to swell, her hands swelled and she started itching all over.  Her throat began to close.  She took a Benadryl immediately (this is day 3).  The symptoms did resolve.   She returned home.  On day four, she had some nausea.  On day five (Monday), she went to work and her tonsils started throbbing.  She ran her bus driver route.  She was itching all over again.  She took another Benadryl . She called Dr. on day 5 after vaccination because of the recurring symptoms.  She also called her allergist.  She had an appointment with her allergist on day 6.  Family Doctor also called back on Day 5 and called a prescription in for Prednisone.  She did not start the Prednisone.  She did see the allergist on day 6. The allergist thinks her reaction might have been due to the preservative in the Moderna product.  It was the only ingredient in both the flu shot (7 years ago) and the Moderna contents.  She advised her to take the Prednisone dose pack (as prescribed by family doctor) to over-ride and she upped her Zyrtec to bid.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Severe right deltoid/shoulder pain
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: 86 y/o female c/o throat swelling 12 minutes after receiving vaccine while in the recovery area for 15 minute recovery period.  Vitals were stable, AAO x4, denied SOB, no visible throat swelling or redness, no dizziness, speaking clearly and in complete sentences, lungs clear to auscultation.  EMS call @ 0922, arrived @ 0935, assessment completed, no worsening of condition, felt the same, declined transport to local ED, signed waiver.  Remained in recovery for additional 15 minutes, DC from recovery @ 0950 accompanied by Adult Daughter throughout the incident, stable at DC.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Urine analysis
Clinical narrative: macular rash started ankles, extended over much of trunk.  No constitutional symptoms.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Blood electrolytes normal, Dizziness, Dyspnoea, Electrocardiogram normal, Laboratory test
Clinical narrative: After first dose, developed SOB and dizziness ("similar to when I had arrhythmia ten years ago.") Hemodynamically stable, no improvement over 15" of monitoring,911 was called and he was transported to ED for urgent medical evaluation.  In ED, EKG was unrevealing. Patient rested comfortably. Patient's lab work is unrevealing.   Patient discharged home and advised to have PCP follow up.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac failure congestive, Dyspnoea, Fatigue, Oedema
Clinical narrative: Patient developed worsening edema and shortness of breath.  Became fatigued and went to Emergency Department.  He was admitted for 3 days with CHF atrial fib.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Fatigue, Headache
Clinical narrative: Mild headache; fatigue; joint aches; unsettled stomach; overall not well that lasted for 7 days
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Skin tightness
Clinical narrative: 6 hours after vaccine administration, patient was itchy. 9 hours after vaccine administration, skin reddened bilaterally on arms. Over next three days, progressive  red rash and itching occurred over arms, chest, back.  On 3/8 rash progressed over both legs, neck, face, and mouth. Patient also experienced swelling in gums and severe facial redness. Patient also had facial swelling and scalp tightness and itchiness. Patient sought medical care at Center on 3/10. She was treated with  titrated over 6 days, and Zyrtec 10 mg daily.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: The patient did not disclose that she had a vaccine prior to signing up to our clinic.  We discovered the information when entering the vaccine information that was given to the patient on 3/11/2021. Contacted our local health department and was instructed to submit a VERS.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Confusional state, Cough, Death, Dehydration
Clinical narrative: Exposure to Covid 19 either on the date of vaccine (2/13/21) or shortly thereafter.  Symptoms of Covid started on Monday (2/15) early morning following shot.  Dr. ordered Covid test on Weds. (2/17). Taken by ambulance to Hospital, approx. 7 pm on Saturday (2/20) with dehydration, low oxygen levels, confusion, shaking and cough.  Admitted to hospital with threats of ventilator up until Weds (2/24) when he was intubated, proned and FINALLY given hydration via IV fluids.  He went into kidney failure on Thursday (2/25) and put on dialysis.  Other organs began shutting down and was taken off the ventilator on Friday (2/26) and did not recover.  He passed away just before 4:00 p.m. on 2/26/21.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Dialysis, Endotracheal intubation, Exposure to SARS-CoV-2, Mechanical ventilation, Multiple organ dysfunction syndrome
Clinical narrative: Exposure to Covid 19 either on the date of vaccine (2/13/21) or shortly thereafter.  Symptoms of Covid started on Monday (2/15) early morning following shot.  Dr. ordered Covid test on Weds. (2/17). Taken by ambulance to Hospital, approx. 7 pm on Saturday (2/20) with dehydration, low oxygen levels, confusion, shaking and cough.  Admitted to hospital with threats of ventilator up until Weds (2/24) when he was intubated, proned and FINALLY given hydration via IV fluids.  He went into kidney failure on Thursday (2/25) and put on dialysis.  Other organs began shutting down and was taken off the ventilator on Friday (2/26) and did not recover.  He passed away just before 4:00 p.m. on 2/26/21.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Renal failure, SARS-CoV-2 test positive, Tremor
Clinical narrative: Exposure to Covid 19 either on the date of vaccine (2/13/21) or shortly thereafter.  Symptoms of Covid started on Monday (2/15) early morning following shot.  Dr. ordered Covid test on Weds. (2/17). Taken by ambulance to Hospital, approx. 7 pm on Saturday (2/20) with dehydration, low oxygen levels, confusion, shaking and cough.  Admitted to hospital with threats of ventilator up until Weds (2/24) when he was intubated, proned and FINALLY given hydration via IV fluids.  He went into kidney failure on Thursday (2/25) and put on dialysis.  Other organs began shutting down and was taken off the ventilator on Friday (2/26) and did not recover.  He passed away just before 4:00 p.m. on 2/26/21.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site rash, Rash pruritic
Clinical narrative: Itchy rash near injection site.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itchy rash near injection site.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site rash, Injection site swelling, Skin warm
Clinical narrative: About 5 days later I noticed a swollen lump at injection site and a light pink rash -- several days later it's still there.  I have no pain - feel fine-- just have the warm lump with the rash --- I have not been to the doctor'- just thought you would want to know about lump and rash.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Lymph node pain, Pharyngeal swelling, Rash erythematous, Rash papular
Clinical narrative: Rash at injection site: red, raised, warm, mildly itchy, about the size of my hand. I noticed it 3 hours ago, but it may have been there for longer. I have been feeling very mild swelling  in my throat and slight tenderness in right-side lymph nodes for about 36 hours, but didn?t think anything of it until I saw the rash.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Skin warm
Clinical narrative: Rash at injection site: red, raised, warm, mildly itchy, about the size of my hand. I noticed it 3 hours ago, but it may have been there for longer. I have been feeling very mild swelling  in my throat and slight tenderness in right-side lymph nodes for about 36 hours, but didn?t think anything of it until I saw the rash.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature increased, Feeling cold, Headache
Clinical narrative: I (the patient) woke up 2 hours after going to bed and could not seem to get warm (shaking uncontrollably) and I was too nauseous to get out of bed to check temperature or take medication. I had taken 2 Motrin at approximately 8pm. I had terrible pain in lower back, hips and legs and was unable to go back to sleep. The nausea subsided enough around 4am to allow me to take my temperature (101.9) and take Tylenol. Temperature was reduced to 100 by 6am. I was unable to get back to sleep after waking at 12:30am and suffered back and hip pain all day on the 23rd. On the 24th through the 26th I had a headache and was unable to sleep without taking a PM product (Tylenol PM). Symptoms continued to get better over the course of the next 3 days.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Sleep disorder, Tremor
Clinical narrative: I (the patient) woke up 2 hours after going to bed and could not seem to get warm (shaking uncontrollably) and I was too nauseous to get out of bed to check temperature or take medication. I had taken 2 Motrin at approximately 8pm. I had terrible pain in lower back, hips and legs and was unable to go back to sleep. The nausea subsided enough around 4am to allow me to take my temperature (101.9) and take Tylenol. Temperature was reduced to 100 by 6am. I was unable to get back to sleep after waking at 12:30am and suffered back and hip pain all day on the 23rd. On the 24th through the 26th I had a headache and was unable to sleep without taking a PM product (Tylenol PM). Symptoms continued to get better over the course of the next 3 days.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient was accidentally given Pfizer vaccine as a second dose when they had previously received Moderna vaccine.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Headache, Pruritus
Clinical narrative: Arm had a redness about 3? in diameter, very itchy, lasted for maybe 6 hours  24 hours after injection I had headache and fatigue that lasted for about 12 hours
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis, Vaginal haemorrhage
Clinical narrative: Patient is a 70 year old female that is post-menopausal. Her first Moderna vaccine dose was given on 2/4/21. Exactly one week later on 2/9/21, the patient had vaginal bleeding that lasted one day. There were small clots in the blood that was discharged. The patient went to the doctor where a urinalysis was performed. The patient had a positive urinalysis and was started on antibiotics. The patient's second dose was on 3/4/21. Exactly one week later on 3/11/21, the patient had vaginal bleeding that lasted a day.  Patient usually takes aspirin 81mg daily, however she stopped this medication prior to both doses being administered. She restarted the aspirin after each Moderna dose.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate decreased, Hyperhidrosis, Hypotension, Nausea
Clinical narrative: Patient c/o nausea and feeling sweaty after receiving vaccine. Symptoms included low HR and hypotension.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Vomiting
Clinical narrative: Extreme nausea and vomiting for 14 hours plus some chilling
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Palpitations
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: heart racing, palpitations-Medium
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Patient advised he sometimes gets dizzy or loses consciousness  with vaccines. After receicing injection, patient said he was feeling dizzy and was supported in chair by pharmacist as patient lost consciousness. Patient regained consciousness after 20-30 seconds and asked to put his feet up on a chair. Patient was given a bottle of water and waited 20-30 minutes until he felt well and was able to walk and stand. Patient waitied an additional 15 minutes in store before departing.  No injury occurred.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Electrocardiogram, Full blood count, Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: Immediate numbness of left arm. After 2 days left face numbness
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head, White blood cell count
Clinical narrative: Immediate numbness of left arm. After 2 days left face numbness
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Myalgia, Nausea, Vomiting
Clinical narrative: PATIENT REPORTS CHILLS, MUSCLE ACHES, AND SEVERE NAUSEA, VOMITING, AND DIARRHEA STARTING 8 HOURS AFTER VACCINATION.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Dry mouth, Fatigue
Clinical narrative: Dizziness, chills, sweats, nausea, exhaustion, weakness, dry mouth
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea
Clinical narrative: Dizziness, chills, sweats, nausea, exhaustion, weakness, dry mouth
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Dizziness, Haemoglobin decreased, Hyperhidrosis, Pain
Clinical narrative: On  3/9 - sore arm On 3/10 - fever, body aches, sore arm On 3/12 - woke up dizzy, sweating, pale., very low BP, severe drop in hemoglobin count. Admitted into hospital.    ER dr name unknown so provided family dr nane
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pallor, Pyrexia
Clinical narrative: On  3/9 - sore arm On 3/10 - fever, body aches, sore arm On 3/12 - woke up dizzy, sweating, pale., very low BP, severe drop in hemoglobin count. Admitted into hospital.    ER dr name unknown so provided family dr nane
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Eye contusion, Swelling face
Clinical narrative: Woke up overnight with a black eye, a pretty good shiner. No trauma to the eye area. I feel great. Face was slightly puffy in the AM.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Blood test, Chest pain, Electrocardiogram normal, Hyperhidrosis
Clinical narrative: After first dose of vaccine, developed 5/10 persistent chest pain accompanied by diaphoresis. Known history of CAD. EMS was called for transport to hospital for urgent medical evaluation.  Per family, the patient was taken to local ED on 2/27/21. Had EKG, blood enzymes x 2 and "everything checked out" and he was discharged home. Family notes that PCP follow up arranged and patient reported anxiety.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Extreme fatigue from 1620 on 1/6 gone when arose at 730 on 1/7 Fever starting at approximately 1900.  Fever broke in the early am approximately 0300 awoke and noted wetness as if had been sweating No fever when arose
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Product administered to patient of inappropriate age, Vomiting
Clinical narrative: 16 year old patient was administered 1st dose of Moderna COVID-19 vaccine even though it is unapproved for those under 18. The patient's mother was present and aware at the time of vaccination. The patient reported nausea/vomiting for one day post-vaccination.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dizziness postural, Nausea
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Additional Details: a few minutes after vaccination, pt expressed nausea and dizziness and was unable to stand due to dizziness. pharmacist assisted patient to the ground to lay down. she said she felt much better after laying down but symptoms returned after she sat back up. symptoms were on and off for about 30 minutes. pt recovered with no issues after about 30 minutes of rest
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Cough, Dizziness, Nausea, Oropharyngeal pain
Clinical narrative: lost voice, sore throat, coughing, sneezing, dizzy, nauseated all within the two and half weeks since I received it .
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: lost voice, sore throat, coughing, sneezing, dizzy, nauseated all within the two and half weeks since I received it .
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient is 17 years old and 9 months, vaccine is currently approved for 18 and over. No adverse events were experienced. We spoke with both the doctor and patient's parents
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Paraesthesia oral, Throat irritation
Clinical narrative: Shortly after receiving vaccine, experienced scratchy throat, difficulty swallowing and tingling of lips. EpiPen administered x 1 without improvement of symptoms. 911 called transferred to hospital by ambulance.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Nausea, Paraesthesia oral, Rash macular, Swelling face
Clinical narrative: Swollen tongue, red,splotchy puffy cheeks, giggly lips , mild nausea Sought medical attention- given epinephrine and prednisone and Benadryl
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: Swollen tongue, red,splotchy puffy cheeks, giggly lips , mild nausea Sought medical attention- given epinephrine and prednisone and Benadryl
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Rash at injection site and itching.
Sex: M
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No other AE reported; temperature excursion involving GARDASIL 9,; This spontaneous report was received from a medical assistant and refers to a 12-year-old Hispanic male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 02-MAR-2021, the patient was vaccinated with improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter, lot # T007035, expiration date 01-MAY-2022 (route of administration and anatomical location were not provided) for prophylaxis. The vaccine was administered by medical assistant. Administered dose of vaccine experienced the temperature excursion of 11 degrees Celsius for 10 hours on 16-FEB-2021. There was no previous temperature excursion. Digital data logger was involved. There was no adverse event reported. At the time of reporting, the patient had not experienced cellulitis, erythema or swelling at the site of the injection.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T007035; expirationdate: 01-MAY-2022; deviceage and unit: 0 ; operatorofdevice: Medical Assistant; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA001526: US-009507513-2103USA001467: US-009507513-2103USA001532:
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Nausea, Pyrexia
Clinical narrative: diarrhea; nausea; low grade fever of 98 or 99; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix) and Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season).   On 8th January 2021, the patient received the 2nd dose of Shingrix. On 11th January 2021, 3 days after receiving Shingrix and an unknown time after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced diarrhea and nausea. In January 2021, the patient experienced fever. On an unknown date, the outcome of the diarrhea, nausea and fever were recovering/resolving.  It was unknown if the reporter considered the diarrhea, nausea and fever to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself. The patient received flu vaccine and Shingrix on November 2020. For tolerance of 1st dose of Shingrix and Flu vaccine , refer case US2021008404. The patient waited two months after 1st dose to get the 2nd shot of Shingrix on 8th January 2021 and on Monday, 11th January 2021 she started to experience diarrhea and nausea.  On Tuesday from the day of reporting it got really bad and today on the day of reporting her symptoms were improving  The Patient also had a low grade fever of 98 or 99 degree Fahrenheit. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021008406:same reporter US-GLAXOSMITHKLINE-US2021008404:same reporter, same product, different dose