chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nervousness, Oropharyngeal discomfort
Clinical narrative: Pt. received the Covid-19 vaccine. She reports symptoms of "feeling her throat weird" pt stated she has a hx of anxiety and was very nervous. RN had Epi on hand pt sat with RN, pt drank water and pt's HR was 88 when she stated she did not feel well at 3:52pm, 15 min after her vaccine was given.    Treatment/intervention: Pt was given water and sat and additional 30 mins after initially feeling unwell. Pt stated she feel fine at 4:08pm. Pt denies any throat or tongue swelling. Pt states she feels fine.    At 4:15pm: HR: 76 O2: 99% BP: 120/80   At 4:30pm: HR: 73 O2 100% BP: 118/78  Pt stated she felt well, she did not have any swelling in face or tongue or difficulty breathing.
Age: 35.0
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Patient was in to have Janssen vaccination at 12:30pm . She waited her appropriate time and felt fine. At 4:50 pm she developed a reaction of hives on the torso, legs and arms. She said she could not take the benadryl because it would be lock up her throat as has happed before.  She tried to contact md office, but they were closed and we suggested she go to ER and she proceeded to go to the ER.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site erythema, Neck pain
Clinical narrative: Redness at injection site and sore shoulder all the way up the neck starting a couple of days after administration of vaccine.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia eye, Pharyngeal hypoaesthesia, Throat tightness
Clinical narrative: Numbness in eyes and throat. Tightness in throat
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given an expired dose of vaccine.  No symptoms reported.  Patient was called back to get active dose less than 12 hours later. Again, No symptoms reported from either vaccine administration.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Apathy, Disturbance in attention, Headache, Insomnia
Clinical narrative: Muscle pain, head aches, loss of sleep,  nausea, loss of motivation, of concentration, anxiety. After 1 week finally feeling better.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle pain, head aches, loss of sleep,  nausea, loss of motivation, of concentration, anxiety. After 1 week finally feeling better.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Headache, Pain in extremity
Clinical narrative: As of today, 4/3/21, 72 hours post vaccine, still experiencing sore arm, headache that won't go away despite taking ibuprofen, hard to breathe - weight on chest.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Erythema, Feeling hot, Miliaria, Pruritus
Clinical narrative: About 5 hours after receiving the covid vaccine I started to feel flustered.  My chin felt hot and a little itchy.  When I looked in the mirror my chest from shoulder to shoulder was red and it looked almost like a prickly heat rash and was slightly itchy.  About an hour later it wasn't as red on my chest.  My chin still is red and feels irritated (like sunburn).  I don't know how else to describe it.   I tried calling Pfizer and no one answered.  I called CDC but the agent was of no help and didn't have any info that I didn't already have.
Age: 43.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever chills severe aches
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypokinesia, Insomnia, Magnetic resonance imaging, Pain in extremity
Clinical narrative: Extreme pain in left shoulder and arm and very limited range of motion within 2 hours.  I could not lift my arm which made it difficult to bathe and dress.  Pain also caused difficulty sleeping.   I iced it and kept it stable in a sling for a week and then gradually started moving it.  My primary care prescribed Ibuprofen 800mg and Diclofenac gel.   The pain and range of motion has improved over the last 12 days.  I still have some pain with certain motions and have dIfficulty sleeping on my left side.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray limb
Clinical narrative: Extreme pain in left shoulder and arm and very limited range of motion within 2 hours.  I could not lift my arm which made it difficult to bathe and dress.  Pain also caused difficulty sleeping.   I iced it and kept it stable in a sling for a week and then gradually started moving it.  My primary care prescribed Ibuprofen 800mg and Diclofenac gel.   The pain and range of motion has improved over the last 12 days.  I still have some pain with certain motions and have dIfficulty sleeping on my left side.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: heart palpitations
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Oral pruritus, Sensation of foreign body, Throat tightness
Clinical narrative: Itching on top of mouth, globus sensation, tightening of throat, coughing  Epi 0.3mg IM given right delt at 0915.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest, Life support, Malaise, Pyrexia, Unresponsive to stimuli
Clinical narrative: patient received the vaccine on March 20th, instantly felt sick, developed a fever.  Never fully felt " Well".  On March 27th her boyfriend discovered her unresponsive from Cardiac arrest, she has been on life support since.  They are pulling the plug today.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Bowel movement irregularity, Chills, Constipation, Diarrhoea
Clinical narrative: body aches, chills, headache, fatigue that began 15 hours after injection and escalated to severe for a few hours. Side effects subsided within 36 hours of vaccine.   9 days later- 3/20/2021- diarrhea for 72 hours, nausea, headaches, fatigue. 3/23/2021 severe bloating, constipation, irregular BM, that is still persisting 26 days later.  4/6/2021- menstrual cycle was due on 4/1/2021 history of very regular cycles, PMS symptoms ongoing for over 2 weeks and menstrual cycle is now 6 days late. Negative pregnancy test, not pregnant.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Menstruation irregular, Nausea, Pain
Clinical narrative: body aches, chills, headache, fatigue that began 15 hours after injection and escalated to severe for a few hours. Side effects subsided within 36 hours of vaccine.   9 days later- 3/20/2021- diarrhea for 72 hours, nausea, headaches, fatigue. 3/23/2021 severe bloating, constipation, irregular BM, that is still persisting 26 days later.  4/6/2021- menstrual cycle was due on 4/1/2021 history of very regular cycles, PMS symptoms ongoing for over 2 weeks and menstrual cycle is now 6 days late. Negative pregnancy test, not pregnant.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pregnancy test negative, Premenstrual syndrome
Clinical narrative: body aches, chills, headache, fatigue that began 15 hours after injection and escalated to severe for a few hours. Side effects subsided within 36 hours of vaccine.   9 days later- 3/20/2021- diarrhea for 72 hours, nausea, headaches, fatigue. 3/23/2021 severe bloating, constipation, irregular BM, that is still persisting 26 days later.  4/6/2021- menstrual cycle was due on 4/1/2021 history of very regular cycles, PMS symptoms ongoing for over 2 weeks and menstrual cycle is now 6 days late. Negative pregnancy test, not pregnant.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort
Clinical narrative: Patient was experiencing her throat feeling funny and she stated she feared her throat would close. Started about 5-10 minutes after administration.  We gave the patient a water and sat and talked to her for the next 25 minutes.  Nothing else occurred and the patient was fine to leave.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Client was 15 years old at time of vaccination of first vaccination on 3/16/21. Client received 2nd dose today, 4/6/21. Consent was completed and signed by guardian with age listed as 16 years old. Birthdate was not verified by staff prior to injection.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was under the recommended age of 18. He was 16 at the time of the vaccination.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Injury associated with device, Needle issue, Syringe issue
Clinical narrative: While uncapping a clean needle to administer vaccine, community health worker (CHW) reports that something hit her glove but she didn't think anything of it.  CHW then proceeded to vaccinate patient with same needle without her preceptor's ( Name, NP) knowledge of possible finger stick. Per (Name), NP she also observed CHW push on the plunger before contact with patient's skin and vaccine leaked onto patient's arm. NP feels that  patient received less that half a dose and feels that patient needs to have her dose repeated. After administering vaccine, CHW removed her gloves and realized that she had a small puncture to her left pointer finger. CHW then went to the bathroom, washed her finger, and made her preceptor aware that she had a needle stick. CHW and NP made clinical lead and pod manager aware of incident. Clinical lead observed CHW to have a small puncture wound to her left pointer finger with no blood or fluids visible. Attempted to find patient to make her aware of needle stick with dirty needle, but she had already left clinic. After checking the system and narrowing down patients by vaccinator it was determined that (Name) was correct patient. TC to patient x 2, left message to return call to clinical lead ASAP.  4/6/21- Clinical lead called patient back and she came in to repeat her second dose. Patient has a scheduled appointment with her PMD for blood work today at 1:30 PM.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever, muscle aches, exhaustion
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Throat irritation
Clinical narrative: Per triage record documented by provider on site. Patient presenting with complaint of throat itch and anxiety. Provider assessed patient administered single dose epi 0.3mg IM. S/S improved patient sent home.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Myalgia, Nausea
Clinical narrative: nausea, fatigue, chills, sweats, muscle aches. No treatment. Cleared up on its own
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Computerised tomogram, Full blood count, Metabolic function test
Clinical narrative: Bell's Palsy on the L side of face on 4/4/2021.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenectomy, Sleep disorder
Clinical narrative: Enlarged and painful lymph nodes under arm / in left arm pit for approximately 5 days following the vaccine. Significant enough that it was uncomfortable for arm to hang at side when standing and would awaken me from sleep if arms was not held out from side.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient was give an expired dose of vaccine. No symptoms reported.  Patient was called back to get active dose less than 12 hours later.  Again, NO symptoms reported from either vaccine administration.  Second shot was given in opposite arm.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Headache, Paraesthesia, Wheezing
Clinical narrative: Shortness of breath, dizziness, tingling hands and feet, headache, wheezing
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Palpitations, Pyrexia
Clinical narrative: Severe chills, fever, fast heartbeat
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Magnetic resonance imaging, Shoulder injury related to vaccine administration, X-ray
Clinical narrative: Patient reports no known time or cause of any shoulder injury prior to or after Flu Vaccine.  Right Shoulder pain within hours after injection, increasing daily pain for several months until increased pain with loss of motion.  Treatment for pain required by PCP. Ortho referral made and completed.  SIRVA explained and suspected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Itchy rash on whole body. Rash developed roughly 2 days after injection on 3/24. Went to doctor on 4/5 and was prescribed prednisone.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Headache, Musculoskeletal stiffness
Clinical narrative: Fever, shaking chills, lower back pain, headache and pain in joints; Ibuprofen; felt better in 36 hours with only stiffness in fingers and full headache; completely better within 72 hours
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: Fever, shaking chills, lower back pain, headache and pain in joints; Ibuprofen; felt better in 36 hours with only stiffness in fingers and full headache; completely better within 72 hours
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Rash around Covid vaccine injection. When I first noticed, my arm felt really itchy and then  I Noticed two lumps around the size of a nickel each.  Less than an hour later itchiness subsided and my arm started to hurt and feel soar like when I first got the Covid vaccine.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Within a few minutes of injection pain at injection site began.  Within 2 hours of injection pain was significant and could not lift arm above shoulders.  Treatment was massage of arm until pain was too much to take any pressure.  After that avoiding touching and avoiding lifting arm was only way to avoid pain.  No medication was taken.  Pain lasted 48 hours from time of injection.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Events: Injection site pain (mild) occurred at time of vaccine administration. Headache (moderate), chills (severe), fever (moderate), and fatigue (moderate) happened about 10 hours afterward, continued for about 14 hours,  and caused disruption in sleep and normal activities.   Treatment: Water and Tylenol.  Outcomes: Everything resolved by 24 hours after vaccine administration except for mild pain in the vaccinated arm.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: Events: Injection site pain (mild) occurred at time of vaccine administration. Headache (moderate), chills (severe), fever (moderate), and fatigue (moderate) happened about 10 hours afterward, continued for about 14 hours,  and caused disruption in sleep and normal activities.   Treatment: Water and Tylenol.  Outcomes: Everything resolved by 24 hours after vaccine administration except for mild pain in the vaccinated arm.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Neck pain, Pain, Pain in extremity
Clinical narrative: Pain in upper arm and neck for close to a week.  Got shot on Wednesday and felt sore throughout body especially around upper arm and neck.  By Friday had biting pain around neck.  Could barely move it on Saturday and Sunday.  Monday the biting pain left and neck pain started to let up.  Tuesday seems like pain is getting better.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Facial discomfort
Clinical narrative: 12:25 "sudden pressure to face" x 15-20 seconds.  Took pt to triage via wheel chair.   EMT & MD at side.   Vitals 140/63, 114, 20  02 98% RA  Pt husb states hx extreme anxiety Pt DC home stable
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Patient fainted within 5~10 seconds after the vaccine; not responding to conversations, not responding to calling her name during the fainting. Patient woke up approximately 5 minutes after fainting, and reported that she started to feel much better. Patient was seated on chair under direct help of pharmacist at the time. No observable injury, did not fell to the floor. EMS was called and arrive, and patient care handed over to EMS.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Audiogram, Deafness unilateral, Magnetic resonance imaging
Clinical narrative: Around the time of the 1st dose of Pfizer Covid-19 vaccine, noticeable deteriorating hearing loss, more rapidly in right ear. Then 2 weeks after 2nd dose, sudden profound hearing loss in left ear occurred.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deafness unilateral, SARS-CoV-2 test
Clinical narrative: Around the time of the 1st dose of Pfizer Covid-19 vaccine, noticeable deteriorating hearing loss, more rapidly in right ear. Then 2 weeks after 2nd dose, sudden profound hearing loss in left ear occurred.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever, muscle pain, headache, nausea - started 12 hours after vaccine and continuing for >12 hours
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Heart rate decreased, Hypotension, Loss of consciousness
Clinical narrative: Passed out 18 hours after vaccine, very low heart rate and blood pressure. Called 911 for ambulance to give saline solution through IV. Was taking to the emergency room and discharged 6 hours later after receiving two bags of saline solution.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Bursitis, Periarthritis
Clinical narrative: Client came today for 2nd Covid shot with husband and explained she got "frozen shoulder" with her 1st dose that began 1 week after the shot was administered. Client had told me she was having physical therapy on the right arm, but would prefer the shot in that arm so she could sleep on the other side. I did not ask more about the injury. Today. 4.6, she told me her shoulder tendon had been loose which was causing her muscle to be loose in that shoulder, so the inflammation could have gone into the bursa causing capsulitis or something similar. The client was not complaining, but did inform me so I can report the adverse effect. Her husband got the shot the same day at the same time and did fine.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Had flue like symptoms, extreme fatigue and lost balance and fell out of bed
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Platelet count decreased
Clinical narrative: 2 severe nosebleeds (have never had a nosebleed in 94 yrs  = first on 27 - second on Mar.3
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: I started feeling tired and achy around 6pm. My left arm is really sore. I have a temperature or 99.6 and a Headache
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Malaise, Nausea, Pyrexia
Clinical narrative: Nausea, chills, fever lasting 3 days.  Joint Pain and malaise for one week, believed to be an RA flare from vaccine
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pruritus, Rash erythematous, Seizure, Throat tightness
Clinical narrative: Patient received her 1st dose of the vaccine and I had her sit down, within 10 minutes she comes to the consultation window and she says she is having a hard time breathing. I take her to the IMZ room and sit her down and she says her throat is closing up.  She is struggling to breathe so I give her a dose of an epipen.  She starts to fill better. she says she is itching and her chest is a little read and has some bumps so I gave her some Benadryl.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Both cheekbones swollen
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dyschromatopsia, Fatigue, Hyperhidrosis, Pallor
Clinical narrative: Vaccine was administered in drive thru. I pulled out after and into one of the waiting spots. About 10 minutes after I was suddenly drenched in sweat and started to see black. My left side of body started to feel a burning sensation. I had been told to honk and put on flashers if anything went wrong. I did and waited more than 30 minutes. No one ever came to check me. After about 10 more minutes I started to feel better but was still pale and my face looked slightly puffy. I never saw anyone so I eventually drove home, drank a ton of water, ate some saltines and then slept a little. Had chills off and on that day and remained tired the next day. Felt fine by day 3
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Vaccine was administered in drive thru. I pulled out after and into one of the waiting spots. About 10 minutes after I was suddenly drenched in sweat and started to see black. My left side of body started to feel a burning sensation. I had been told to honk and put on flashers if anything went wrong. I did and waited more than 30 minutes. No one ever came to check me. After about 10 more minutes I started to feel better but was still pale and my face looked slightly puffy. I never saw anyone so I eventually drove home, drank a ton of water, ate some saltines and then slept a little. Had chills off and on that day and remained tired the next day. Felt fine by day 3
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Asthenia, Chest pain, Chills
Clinical narrative: 2nd dose symptoms: dragging/low energy, chills, upset stomach, onset of sudden constipation, stomach swelling, runny nose, constant taste of a chemical, uncomfortable/not a pain in throat, and sore arm.  About 4:00 PM, I felt pains in my chest and I could not hear.  My ears felt very hot and then became so dizzy I fell to the ground.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Deafness, Dizziness, Dysgeusia, Fall
Clinical narrative: 2nd dose symptoms: dragging/low energy, chills, upset stomach, onset of sudden constipation, stomach swelling, runny nose, constant taste of a chemical, uncomfortable/not a pain in throat, and sore arm.  About 4:00 PM, I felt pains in my chest and I could not hear.  My ears felt very hot and then became so dizzy I fell to the ground.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity, Rhinorrhoea
Clinical narrative: 2nd dose symptoms: dragging/low energy, chills, upset stomach, onset of sudden constipation, stomach swelling, runny nose, constant taste of a chemical, uncomfortable/not a pain in throat, and sore arm.  About 4:00 PM, I felt pains in my chest and I could not hear.  My ears felt very hot and then became so dizzy I fell to the ground.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Vomiting
Clinical narrative: Headache (more of a migraine), chills, vomiting, body aches
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease, Pancreatitis acute
Clinical narrative: acid reflux and possible acute pancreatitis
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Facial pain, Fatigue, Pain in jaw, Pyrexia
Clinical narrative: fever, chills, fatigue, jaw and face pain. Took Tylenol and slept, feeling better 12 hours later
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Facial pain, Fatigue, Pyrexia
Clinical narrative: fever, chills, fatigue, jaw and face pain. Took Tylenol and slept, feeling better 12 hours later
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot
Clinical narrative: Pt is working at vaccine site.  1 hour 1 15 post vaccine pt states she felt hot in her face and hands.  Came to Triage 1 where evaluated by EMT & MD.  BP 118/55, HR 52, Resp 20, 02 100% RA.  Pt stayed for 10 mins and then said she was fine and went back to work.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash macular
Clinical narrative: Half dollar sized rash on top of right hand with secondary quarter sized rash splotch on right wrist
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: Nausea, headache, body aches, fever
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cold sweat, Fall, Heart rate, Nausea
Clinical narrative: Patient fell off chair, appeared to be having a seizure.  Patient was very pale, clammy and reported nausea.  Patient was given cold compress to back of neck, blood pressure and pulse monitored.  911 was called and arrived approx 10 minutes after event.  Patient was conscious and aware when EMS arrived.  Patient reported history of fainting and appearing to have seizures in the past.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pallor, Seizure
Clinical narrative: Patient fell off chair, appeared to be having a seizure.  Patient was very pale, clammy and reported nausea.  Patient was given cold compress to back of neck, blood pressure and pulse monitored.  911 was called and arrived approx 10 minutes after event.  Patient was conscious and aware when EMS arrived.  Patient reported history of fainting and appearing to have seizures in the past.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Paraesthesia
Clinical narrative: Fatigue and tingling lasted 2 days.  Diarrhea has been ongoing since 03/16/2021.  Have returned to the eating from the Autoimmune Paleo Diet plan with no success to date
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Bacterial test negative, Headache, Herpes simplex test negative, Pyrexia, Treponema test negative
Clinical narrative: Headache and Fever (Friday) On Saturday, vaginal pain worsening into multiple vaginal ulcers, very painful and some itching Given antiviral and lidocaine for pain Improved in around three days
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal ulceration, Vulvovaginal pain, Vulvovaginal pruritus
Clinical narrative: Headache and Fever (Friday) On Saturday, vaginal pain worsening into multiple vaginal ulcers, very painful and some itching Given antiviral and lidocaine for pain Improved in around three days
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vomiting
Clinical narrative: Vomit Dizziness
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Insomnia, Malaise, Syncope
Clinical narrative: PT STATED NOT FEELING WELL AND SHE SAID SHE IS NOT ABLE TO SEE. PT FELT DIZZY AND FAINTED. SHE FELT BETTER AFTER ELEVATING FEET AND WAITED 30 MIN FOR OBERVATION.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Diarrhoea, Dyspnoea, Nausea, Paraesthesia oral
Clinical narrative: Awoke in the middle of the night to mild/moderate anaphylaxis - tingling throat and tongue, swelling of throat and tongue, difficulty breathing, nausea, gagging, diarrhea - lasting for about 30 minutes - all symptoms occurred at the same time
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal paraesthesia, Pharyngeal swelling, Retching, Swollen tongue
Clinical narrative: Awoke in the middle of the night to mild/moderate anaphylaxis - tingling throat and tongue, swelling of throat and tongue, difficulty breathing, nausea, gagging, diarrhea - lasting for about 30 minutes - all symptoms occurred at the same time
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Myalgia, Pyrexia
Clinical narrative: She had fever and muscle aches for 2 days and she had headache and stomach upset for 5 days after vaccine given
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Memory impairment, Oral pruritus, Paraesthesia
Clinical narrative: Pt arrived to observation area post first pfizer covid vaccination. Pt. Presented in observation with no symptoms and sat down in chair. At 2:12 pm patient raised hand for assistance. At that time patient stated that she was "dizzy." When asked if she felt going to pass out she replied, yes. Patient was placed on the floor with her head down and feet up.  Patient continued to complain of dizziness and numbness in her feet. Placed pulse ox on Patient. HR 53 O2 93, Patient continued to be alert, but was having difficulty remembering her age and previous symptoms persisted and she stated she initially felt itchiness in her mouth and throat. At 2:18 EPIPEN was given IM 0.3mg Left anterolateral thigh (Lot #0GM229 EXP 12/21). Ambulance was called. 2:20 BP 110/68 HR 78 02 95. Patient began to state her symptoms were improving still complaint of tingling in fingers and legs. Able to answer questions appropriately. She was returned to sitting in the chair. 2:23 BP 100/70 HR 85 o2 100%. Patient remained alert and oriented Heart rate and pulse remained stable. 2:30p Paramedics arrived, Patient was taken to hospital via ambulance.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Pt arrived to observation area post first pfizer covid vaccination. Pt. Presented in observation with no symptoms and sat down in chair. At 2:12 pm patient raised hand for assistance. At that time patient stated that she was "dizzy." When asked if she felt going to pass out she replied, yes. Patient was placed on the floor with her head down and feet up.  Patient continued to complain of dizziness and numbness in her feet. Placed pulse ox on Patient. HR 53 O2 93, Patient continued to be alert, but was having difficulty remembering her age and previous symptoms persisted and she stated she initially felt itchiness in her mouth and throat. At 2:18 EPIPEN was given IM 0.3mg Left anterolateral thigh (Lot #0GM229 EXP 12/21). Ambulance was called. 2:20 BP 110/68 HR 78 02 95. Patient began to state her symptoms were improving still complaint of tingling in fingers and legs. Able to answer questions appropriately. She was returned to sitting in the chair. 2:23 BP 100/70 HR 85 o2 100%. Patient remained alert and oriented Heart rate and pulse remained stable. 2:30p Paramedics arrived, Patient was taken to hospital via ambulance.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity, Somnolence, Tenderness
Clinical narrative: Drowsiness, pain in arm and up shoulder. Chills and fatigue 10-13 hours after shot. Felt better 24 hours after shot except for arm tenderness, which lasted an additional 24 hours.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Diarrhoea, Fatigue, Injection site erythema, Myalgia
Clinical narrative: sore muscles fatigue diahrea chest pain red wealt at injection site
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: sore muscles fatigue diahrea chest pain red wealt at injection site
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal paraesthesia
Clinical narrative: Client c/o tingling in throat 15 minutes after vaccination. Observed and symptoms resolved. VS stable. Discharged home at 12:28p.m.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dyspnoea, Eye swelling, Swelling, Swelling face
Clinical narrative: anaphylaxis response Swelling of neck/face/eyes, difficulty in breathing
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Urticaria
Clinical narrative: reh hives on left and right forearm from wrist to elbow
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Injection site abscess, Loss of consciousness, Muscle twitching
Clinical narrative: Pt received a vaccine of Johnson and Johnson (Janssen) Covid-19 vaccine. She asked if it was normal that her arm hurt really bad, then she stated she was getting dizzy and light headed. I instructed her to sit on the floor so she would not fall down. She sat on the floor and immediately passed out. She remained unconscious for 60- 90 seconds. We laid her into the prone position. Her arms were twitching. She regained consciousness. 911 was alerted and responded. Pt refused to leave with them. She sat with un an additional 15 minutes before she left for a therapy appointment.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Tinnitus
Clinical narrative: Ear pressure and  humming sound, in right ear.  Felt like I was in high elevation could not get ear to ? pop?.  After two weeks finally starting to feel better.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: Chills, achy body, experiencing headaches for 3 days as well as fatigue still.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: 102 fever, body aches, chills, headache, fatigue.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: 102 fever, body aches, chills, headache, fatigue.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Pyrexia, Respiratory distress, Supraventricular tachycardia
Clinical narrative: Day 2, 3/25, with a fever of 100.5 and mild chest pain with difficulty of breathing. Woke day 3, 3/26, with severe chest pain, difficulty of breathing and a heartrate while resting from 140-180. Symptoms persisted all morning resulting in a call to 911 for assistance. Hospitalized evening of 3/26 with symptoms persisting until late night of 3/28 after struggling with bringing down the heartrate. Diagnosed with Supraventricular tachycardia paroxysmal, Respiratory Distress, and Thrombocytosis.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombocytosis
Clinical narrative: Day 2, 3/25, with a fever of 100.5 and mild chest pain with difficulty of breathing. Woke day 3, 3/26, with severe chest pain, difficulty of breathing and a heartrate while resting from 140-180. Symptoms persisted all morning resulting in a call to 911 for assistance. Hospitalized evening of 3/26 with symptoms persisting until late night of 3/28 after struggling with bringing down the heartrate. Diagnosed with Supraventricular tachycardia paroxysmal, Respiratory Distress, and Thrombocytosis.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Erythema, Fatigue, Pain, Pruritus
Clinical narrative: 12-15hrs after injection, general fatigue, loss of appetite, and minor aches treated effectively with IBU, APAP, and sleep.  The second morning, itching sensation on forearms with ~6 minor welts forming on right fore arm. 18month prior, had a sever exposure to poision oak treated with high dose prednisone. Forearms were very red, welts, and itchy. Itchy sensation occurs occasionally with exposure to hot shower water, but only transient. Post vaccine, much more severe itching sensation with formation of small (<2mm) hives. Fatigue had subsided by this time.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: 12-15hrs after injection, general fatigue, loss of appetite, and minor aches treated effectively with IBU, APAP, and sleep.  The second morning, itching sensation on forearms with ~6 minor welts forming on right fore arm. 18month prior, had a sever exposure to poision oak treated with high dose prednisone. Forearms were very red, welts, and itchy. Itchy sensation occurs occasionally with exposure to hot shower water, but only transient. Post vaccine, much more severe itching sensation with formation of small (<2mm) hives. Fatigue had subsided by this time.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Injection site reaction, Lethargy, Pain in extremity
Clinical narrative: chills, lethargy, joint pain, significant pain in vaccination arm starting 16 hours post vaccine; ending 16 hours later.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Myalgia
Clinical narrative: severe head ache, on off fever (100.7-102), muscle ache and fatigue (flu like), chills
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: severe head ache, on off fever (100.7-102), muscle ache and fatigue (flu like), chills
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Extreme fatigue for approximately 36-48 hours along with mild body aches
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Computerised tomogram normal, Fatigue, Laboratory test normal, Retinal migraine
Clinical narrative: Ocular migraine 6 days after first dose, followed by vertigo and fatigue lasting for a week and a half thus far.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Ocular migraine 6 days after first dose, followed by vertigo and fatigue lasting for a week and a half thus far.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: PRIMARY (1st episode) of Shingles. Had Shingrex vaccine series 2019
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: improperly stored ROT ATEQ was administered today; No adverse event; This spontaneous report was received from a licensed practical nurse and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.  On 19-MAR-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot number: 1688830 was verified as valid, expiration date was not provided but upon internal validation established as 04-DEC-2021, 2 ml, orally for prophylaxis. The vaccine experienced temperature excursion of 47.1 degree Fahrenheit for 10 minutes. There was no previous temperature excursion detected. The digital data logger was involved. No other adverse event was reported.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No other adverse events; temperature excursion occurred/ ROTATEQ was administered at the temperature excursion occurred; This spontaneous report was received from a physician assistant and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 18-MAR-2021, the patient was vaccinated with incorrectly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1707585 with expiration date on 21-FEB-2022, 2 milliliter, orally for prophylaxis. The vaccine underwent a temperature excursion of 35.4 degrees Fahrenheit for 1 hour and 13 minutes. Digital data logger was not involved.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No other adverse events; PROQUAD was administered after the excursion occurred; This non-valid spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 23-MAR-2021 the patient was vaccinated with incorrectly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 ml, lot # T029103 with expiration date on 23-FEB-2022, therapy type rHA (route of administration was unknown) for prophylaxis. The vaccine underwent a temperature excursion of 6 degrees Fahrenheit for 1 hour and 54 degrees Fahrenheit for 50 minutes. No adverse event was reported. Digital data logger was not involved.
Age: 19.0
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Underdose
Clinical narrative: No additional AE; A 19 year old Patient was administered the 0.5mL VAQTA Pediatric Formulation instead of the VAQTA Adult Formulation; A 19 year old Patient was administered the 0.5mL VAQTA Pediatric Formulation instead of the VAQTA Adult Formulation; This spontaneous report was received from a nurse and refers to a 19-year-old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 11-MAR-2021, the patient was vaccinated with hepatitis a pediatric dose of vaccine, inactivated (VAQTA), 0.5 milliliter (route of administration, lot# and expiration date were unknown) for prophylaxis instead of an adult formulation of hepatitis a vaccine, inactivated (VAQTA). No adverse event was reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's; temperature excursion for refrigerated products. GARDASIL 9 was administered to patient; This spontaneous report was received from an office manager and refers to a patient of an unknown age and gender.  No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 23-MAR-2021, the patient was vaccinated with incorrectly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 dosage form, lot # T008152 with expiration date on 21-JUN-2022 (route of administration was unknown) for prophylaxis. The vaccine underwent a temperature excursion of 48.61 degrees Fahrenheit or 30 minutes. Digital data logger was involved. No previous excursions occurred. No adverse event was reported. 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: T008152; expirationdate: 21-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HPV9
Symptoms: No adverse event
Clinical narrative: Potential adverse event as prescription was received for GARDASIL 9 for a patient age 60; Potential adverse event as prescription was received for GARDASIL 9 for a patient age 60/ The vaccine was not given per the reporter's knowledge but the prescription was sent to the pharmacy; Potential adverse event as prescription was received for GARDASIL 9 for a patient age 60; No other AE; This spontaneous report was received from a pharmacist, via company representative and refers to a 60-year-old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On an unknown date, the patient was prescribed hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route of administration, lot # and expiration date were unknown) for prophylaxis. The prescribing information stated the vaccine was for patients aged 9 - 45 years of age. The vaccine was not given per the reporter's knowledge but the prescription was sent to the pharmacy. No adverse event was reported.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: hives; Per mother of the patient he has rash break out all over his body (Rash and itching); Information has been received from a nurse, referring to 12 years old a male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 18-MAR-2021 early in the morning (discrepant information also reported as 08-MAR-2021), the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly (anatomical location, lot number and expiration date were not reported) for prophylaxis. Per nurse he had no issues with the first dose of the vaccine.      On the same date, the patient experienced a rash break out all over his body (rash and itching) and hives. The patient was not admitted to the hospital, just treated with predsione for 5 days by the emergency department and then was discharged.  The outcome of hives and rash pruritic was reported as resolved informed as "the patient is fine now".       The casuality assessment between the vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the aforementioned events was not provided.
Age: 9.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AE reported; received the VARlVAX too early, on 25-MAR-2021; This spontaneous report was received from an office manager and refers to a 9-year-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 10-MAR-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (dose number, dose, route of administration, anatomical location, lot number and expiration date were not reported). On 25-MAR-2021, the patient was vaccinated too early with varicella virus vaccine live (oka/merck)(VARIVAX) lot # S022755, expiration date: 22-JUL-2021 (dose number, dose, route of administration and anatomical location were not reported) for prophylaxis ( inappropriate schedule of product administration).  No additional adverse event was reported.
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Arthralgia, Diarrhoea, Malaise, Serum sickness
Clinical narrative: had stomach pain; serum sickness; severe face swelling; she didn't feel well; diarrhea; joint pain after having the vaccine; This spontaneous report was received from a consumer, concerning a currently 66-years-old female patient. The patient did not have concomitant therapies and pertinent medical history. Her concurrent conditions included a seasonal allergy.   On an unknown date in 1994, the patient was vaccinated with hepatitis b vaccine (recombinant) (manufacturer unknown) for hepatitis B protection (prophylaxis), route of administration reported as "injection" (strength, dose, schedule, anatomical location, lot number, and expiration date not reported).  Subsequently, the patient experienced serum sickness, she did not feel well (malaise), had stomach pain (abdominal pain upper), diarrhea and severe face swelling as well as joint pain (arthralgia) after received the vaccine. Therefore, the patient sough medical attention and received antihistamines as a treatment for the events, but she did not perform any laboratories or studies.   The outcome of the events was reported as recovered on an unknown date in 1995. The causal relationship between the events and the suspect vaccine were unknown.
Sex: F
Vaccine: HEP
Symptoms: Swelling face
Clinical narrative: had stomach pain; serum sickness; severe face swelling; she didn't feel well; diarrhea; joint pain after having the vaccine; This spontaneous report was received from a consumer, concerning a currently 66-years-old female patient. The patient did not have concomitant therapies and pertinent medical history. Her concurrent conditions included a seasonal allergy.   On an unknown date in 1994, the patient was vaccinated with hepatitis b vaccine (recombinant) (manufacturer unknown) for hepatitis B protection (prophylaxis), route of administration reported as "injection" (strength, dose, schedule, anatomical location, lot number, and expiration date not reported).  Subsequently, the patient experienced serum sickness, she did not feel well (malaise), had stomach pain (abdominal pain upper), diarrhea and severe face swelling as well as joint pain (arthralgia) after received the vaccine. Therefore, the patient sough medical attention and received antihistamines as a treatment for the events, but she did not perform any laboratories or studies.   The outcome of the events was reported as recovered on an unknown date in 1995. The causal relationship between the events and the suspect vaccine were unknown.
Age: 16.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: there have been no other AE reported from the patient; Caller states she administered expired MMR II; This spontaneous report was received from a certified nurse practitioner referring to a 16-years-old patient, of unknown gender. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies, and concomitant medications were not provided.  On 23-MAR-2021,  the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant Human albumin (rHA) (M-M-R II) 0.5 mL (dosage regimen and route of administration were not reported) lot # S007811, expiration date 14-MAR-2021, as prophylaxis.  The reporter also stated that the vaccine had not undergone any temperature excursions, and there have been no other adverse event (AE) from the patient.