chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given Moderna 0.5mg 1st dose instead of Pfizer 0.3mg. No s/s of any adverse reaction noted during 15min wait time. Family aware of vaccine error.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Unauthorized age group received Moderna vaccine on 10/22/2021. No known adverse effects.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Paraesthesia oral, Swollen tongue, Throat irritation
Clinical narrative: following administration of booster dose. Patient reports tongue senation (swelling and tingling) and tickling back of the throat. patient was assessed by onsite provider at 11:28. Lung sounds normal and no wheezing.  Epi given to patient at 11:31. EMS was called 11:38 for patient. Pt stable when paramedics arrive.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram pulmonary abnormal, Cardiomyopathy, Echocardiogram, Ejection fraction decreased, Pulmonary embolism
Clinical narrative: Pulmonary embolism bilaterally.  Also severe cardiomyopathy, LVEF 33%  on 12/13/21
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Injection site hypoaesthesia
Clinical narrative: Numbness in left cheek and jaw, slight numbness in lips. Movement is normal so far. Numbness down left arm that comes and goes.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain, lefthand side
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given a booster too soon.  initial series was 7/29/21, 8/19/21. Booster given on 12/9/21.  Pfizer vaccine given all three times.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Adult failure to thrive, Angiogram pulmonary abnormal, COVID-19, COVID-19 pneumonia
Clinical narrative: Case completed primary Covid series in January 2021, and a booster on 8/16/21 (Pfizer BionTech Lot # EW0176, Left Deltoid), then was hospitalized for Covid on 9/29/2021. * Acute hypoxemic respiratory failure due to COVID-19 Assessment & Plan Pt w/ acute hypoxemic respiratory failure due to covid-19 pneumonia. He is on day 5-7 of symptoms at admission. He is experiencing failure to thrive plus hypoxia and has bilateral pulmonary infiltrates seen on chest xray and CTPA. No PE seen. Was on 2-4 liters in ED. De-sats w/ activity. He is on Ocrevus (ocrelizumab) q6months (next dose November) which is a CD-20 targeting monoclonal antibody used for MS, it is considered an immunosuppressant. Unclear how it affects his ability to respond to covid-19.    Plan:  - dexamethasone 6mg daily for 10 days through discharge prescribed - remdesivir 200mg -> 100mg daily for 5 days total through 3/oct pm while inpatient - daily CMP while on remdes - discussed importance of avoiding atelectasis such as use of incentive spirometer, ambulation, sitting in chair, self prone    Severe sepsis  Assessment & Plan In the setting of strong physiologic response to covid-19 pneumonia which includes fever, tachypnea and tachycardia pt met severe sepsis criteria.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray abnormal, Lung infiltration, Metabolic function test, Oxygen saturation decreased, Pyrexia
Clinical narrative: Case completed primary Covid series in January 2021, and a booster on 8/16/21 (Pfizer BionTech Lot # EW0176, Left Deltoid), then was hospitalized for Covid on 9/29/2021. * Acute hypoxemic respiratory failure due to COVID-19 Assessment & Plan Pt w/ acute hypoxemic respiratory failure due to covid-19 pneumonia. He is on day 5-7 of symptoms at admission. He is experiencing failure to thrive plus hypoxia and has bilateral pulmonary infiltrates seen on chest xray and CTPA. No PE seen. Was on 2-4 liters in ED. De-sats w/ activity. He is on Ocrevus (ocrelizumab) q6months (next dose November) which is a CD-20 targeting monoclonal antibody used for MS, it is considered an immunosuppressant. Unclear how it affects his ability to respond to covid-19.    Plan:  - dexamethasone 6mg daily for 10 days through discharge prescribed - remdesivir 200mg -> 100mg daily for 5 days total through 3/oct pm while inpatient - daily CMP while on remdes - discussed importance of avoiding atelectasis such as use of incentive spirometer, ambulation, sitting in chair, self prone    Severe sepsis  Assessment & Plan In the setting of strong physiologic response to covid-19 pneumonia which includes fever, tachypnea and tachycardia pt met severe sepsis criteria.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 RNA, Sepsis, Tachycardia, Tachypnoea
Clinical narrative: Case completed primary Covid series in January 2021, and a booster on 8/16/21 (Pfizer BionTech Lot # EW0176, Left Deltoid), then was hospitalized for Covid on 9/29/2021. * Acute hypoxemic respiratory failure due to COVID-19 Assessment & Plan Pt w/ acute hypoxemic respiratory failure due to covid-19 pneumonia. He is on day 5-7 of symptoms at admission. He is experiencing failure to thrive plus hypoxia and has bilateral pulmonary infiltrates seen on chest xray and CTPA. No PE seen. Was on 2-4 liters in ED. De-sats w/ activity. He is on Ocrevus (ocrelizumab) q6months (next dose November) which is a CD-20 targeting monoclonal antibody used for MS, it is considered an immunosuppressant. Unclear how it affects his ability to respond to covid-19.    Plan:  - dexamethasone 6mg daily for 10 days through discharge prescribed - remdesivir 200mg -> 100mg daily for 5 days total through 3/oct pm while inpatient - daily CMP while on remdes - discussed importance of avoiding atelectasis such as use of incentive spirometer, ambulation, sitting in chair, self prone    Severe sepsis  Assessment & Plan In the setting of strong physiologic response to covid-19 pneumonia which includes fever, tachypnea and tachycardia pt met severe sepsis criteria.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Patient is 12 years old and received the 5 to 11 years dose, no negative outcomes occurred.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Fall, Haemorrhagic stroke, Loss of consciousness
Clinical narrative: After taking the vaccine when she was about to leave she had a hemorrhage stroke and fell unconscious  which cause her to be rushed to the ER. She later passed away.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given a  Pfizer booster too soon and without EUA clearance
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Swelling
Clinical narrative: Rash in all body areas, itching, swelling,
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Cardiac flutter, Feeling abnormal, Feeling jittery, Hypertension
Clinical narrative: 12/11 vaccination  2AM started to feel really bad; heart fluttering, anxious, jittery; lasted about 24 hours.  BP was very high165/114 at its highest. Lasted in 150's for the rest of the week. I drove the the ER but it was full of patients and I figured it was full of COVID patients, so I left before entering. 12/15 telehealth w/ kidney doctor. Called me in a new BP medication, Monitor for a week and reevaluate then. I suspect this was caused by the vaccine. I just know that I felt fine until shortly after I had the vaccine. I have been on BP meds since 2016 and numbers  stay around130/90's.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Fully vaccinated and tested positive for covid-19
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Pain in extremity, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: After getting the vaccine a couple of months later I had a break through after having COVID-19. Some side effects I had after getting the vaccine was a sore arm and experienced fatigue.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Immediate post-injection reaction, Incoherent, Loss of consciousness, Posture abnormal
Clinical narrative: Vaccinator gave the IMZ (Pfizer). Immediately after, she sat down to write the IMZ on his personal IMZ record card. Vaccinator observed his head going forward, then leaning forward. His mom stepped out of the way and he fell out of the chair onto his head. He appeared to be having a seizure when he initially hit the ground and then when waking up. He was incoherent for about 10 seconds. We kept him on the floor and supported him while applying ice packs to the back of his neck. He was coherent and breathing normally within seconds. He could communicate his needs and told us he felt fine. We called EMS to have EMS evaluate him - because we thought he had a mild seizure and a possible concussion. EMS took over and took him to the hospital for further evaluation. His family will be contacted tomorrow to check on his condition
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Respiration abnormal, Seizure like phenomena
Clinical narrative: Vaccinator gave the IMZ (Pfizer). Immediately after, she sat down to write the IMZ on his personal IMZ record card. Vaccinator observed his head going forward, then leaning forward. His mom stepped out of the way and he fell out of the chair onto his head. He appeared to be having a seizure when he initially hit the ground and then when waking up. He was incoherent for about 10 seconds. We kept him on the floor and supported him while applying ice packs to the back of his neck. He was coherent and breathing normally within seconds. He could communicate his needs and told us he felt fine. We called EMS to have EMS evaluate him - because we thought he had a mild seizure and a possible concussion. EMS took over and took him to the hospital for further evaluation. His family will be contacted tomorrow to check on his condition
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Echocardiogram, Electrocardiogram, Electrocardiogram T wave inversion, Flank pain
Clinical narrative: At 48 hours (12/13/21), developed left sided flank pain. Progressed to severe sub-sternal chest pain on 12/15/21 prompting ED visit. Chest pain radiated to neck, worse with deep inspiration, relieved with sitting forward. Chest pain associated with diaphoresis and vomiting secondary to pain. EKG changes: new T wave inversions V4-V6, and I and II Bedside echo without clinically significant effusion. Troponin negative x 2 and discharged home with presumptive diagnosis of pericarditis/myocarditis.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Myocarditis, Pain, Pericardial effusion, Troponin
Clinical narrative: At 48 hours (12/13/21), developed left sided flank pain. Progressed to severe sub-sternal chest pain on 12/15/21 prompting ED visit. Chest pain radiated to neck, worse with deep inspiration, relieved with sitting forward. Chest pain associated with diaphoresis and vomiting secondary to pain. EKG changes: new T wave inversions V4-V6, and I and II Bedside echo without clinically significant effusion. Troponin negative x 2 and discharged home with presumptive diagnosis of pericarditis/myocarditis.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: At 48 hours (12/13/21), developed left sided flank pain. Progressed to severe sub-sternal chest pain on 12/15/21 prompting ED visit. Chest pain radiated to neck, worse with deep inspiration, relieved with sitting forward. Chest pain associated with diaphoresis and vomiting secondary to pain. EKG changes: new T wave inversions V4-V6, and I and II Bedside echo without clinically significant effusion. Troponin negative x 2 and discharged home with presumptive diagnosis of pericarditis/myocarditis.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urethral pain
Clinical narrative: I started to feel pain/itchiness in my urethra area. I haven?t seen a doctor as it?s not become worrisome yet. This occurred about 36-48 hours after the booster vaccine of the same brand.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Swelling
Clinical narrative: Patient received booster Pfizer vaccine in left arm.  She now has swelling in left arm and surrounding area of chest.  I suggested she have it looked at by doctor.
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood potassium decreased, COVID-19, Chest X-ray normal, Condition aggravated
Clinical narrative: Patient is a 99 y.o. female with history of CAD, HTN, HLD, spinal stenosis, breast ca, who presents from ALF with 1-2 weeks malaise, found to have UTI and admitted for UTI treatment and PT consult.   HPI Patient is a 99 y.o. female with history of CAD, HTN, HLD, spinal stenosis, breast ca, who presents with BIBA from ALF with c/o multiple days of feeling unwell, being in bed 8-9 days.   Patient has felt very fatigued, and weak over the last 1-2 weeks. The only other specific symptoms she is experiencing is pain from her hemorrhoids. Otherwise, she denies fevers or chills, rhinorrhea, sore throat, chest pain, dyspnea, cough, abdominal pain, nausea/vomiting, change in bowel habits, urinary symptoms. Given persistence of symptoms presented to ED   Resides in an assisted living, and is quite active.   On arrival to ED vitals were unremarkable. Physical exam only notable for one small mildly inflamed external hemorrhoid. Labs demonstrated potassium 2.9, troponin 23-- > 26, WBC 11, Hb 10, UA >100, 20-50 hyaline casts, 3-5 granular casts. CXR without acute process. She was treated with 500 cc NS, 250 cc NS with 40 M EQ of potassium, and 40 mEq of oral potassium, ceftriaxone.she was a 2 person assist to the commode, and thus was admitted to medicine for further management.
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Haemoglobin decreased, Haemorrhoids, Loss of personal independence in daily activities, Malaise
Clinical narrative: Patient is a 99 y.o. female with history of CAD, HTN, HLD, spinal stenosis, breast ca, who presents from ALF with 1-2 weeks malaise, found to have UTI and admitted for UTI treatment and PT consult.   HPI Patient is a 99 y.o. female with history of CAD, HTN, HLD, spinal stenosis, breast ca, who presents with BIBA from ALF with c/o multiple days of feeling unwell, being in bed 8-9 days.   Patient has felt very fatigued, and weak over the last 1-2 weeks. The only other specific symptoms she is experiencing is pain from her hemorrhoids. Otherwise, she denies fevers or chills, rhinorrhea, sore throat, chest pain, dyspnea, cough, abdominal pain, nausea/vomiting, change in bowel habits, urinary symptoms. Given persistence of symptoms presented to ED   Resides in an assisted living, and is quite active.   On arrival to ED vitals were unremarkable. Physical exam only notable for one small mildly inflamed external hemorrhoid. Labs demonstrated potassium 2.9, troponin 23-- > 26, WBC 11, Hb 10, UA >100, 20-50 hyaline casts, 3-5 granular casts. CXR without acute process. She was treated with 500 cc NS, 250 cc NS with 40 M EQ of potassium, and 40 mEq of oral potassium, ceftriaxone.she was a 2 person assist to the commode, and thus was admitted to medicine for further management.
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain, SARS-CoV-2 test positive, Troponin increased, Urinary casts
Clinical narrative: Patient is a 99 y.o. female with history of CAD, HTN, HLD, spinal stenosis, breast ca, who presents from ALF with 1-2 weeks malaise, found to have UTI and admitted for UTI treatment and PT consult.   HPI Patient is a 99 y.o. female with history of CAD, HTN, HLD, spinal stenosis, breast ca, who presents with BIBA from ALF with c/o multiple days of feeling unwell, being in bed 8-9 days.   Patient has felt very fatigued, and weak over the last 1-2 weeks. The only other specific symptoms she is experiencing is pain from her hemorrhoids. Otherwise, she denies fevers or chills, rhinorrhea, sore throat, chest pain, dyspnea, cough, abdominal pain, nausea/vomiting, change in bowel habits, urinary symptoms. Given persistence of symptoms presented to ED   Resides in an assisted living, and is quite active.   On arrival to ED vitals were unremarkable. Physical exam only notable for one small mildly inflamed external hemorrhoid. Labs demonstrated potassium 2.9, troponin 23-- > 26, WBC 11, Hb 10, UA >100, 20-50 hyaline casts, 3-5 granular casts. CXR without acute process. She was treated with 500 cc NS, 250 cc NS with 40 M EQ of potassium, and 40 mEq of oral potassium, ceftriaxone.she was a 2 person assist to the commode, and thus was admitted to medicine for further management.
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection, Urine analysis, White blood cell count increased
Clinical narrative: Patient is a 99 y.o. female with history of CAD, HTN, HLD, spinal stenosis, breast ca, who presents from ALF with 1-2 weeks malaise, found to have UTI and admitted for UTI treatment and PT consult.   HPI Patient is a 99 y.o. female with history of CAD, HTN, HLD, spinal stenosis, breast ca, who presents with BIBA from ALF with c/o multiple days of feeling unwell, being in bed 8-9 days.   Patient has felt very fatigued, and weak over the last 1-2 weeks. The only other specific symptoms she is experiencing is pain from her hemorrhoids. Otherwise, she denies fevers or chills, rhinorrhea, sore throat, chest pain, dyspnea, cough, abdominal pain, nausea/vomiting, change in bowel habits, urinary symptoms. Given persistence of symptoms presented to ED   Resides in an assisted living, and is quite active.   On arrival to ED vitals were unremarkable. Physical exam only notable for one small mildly inflamed external hemorrhoid. Labs demonstrated potassium 2.9, troponin 23-- > 26, WBC 11, Hb 10, UA >100, 20-50 hyaline casts, 3-5 granular casts. CXR without acute process. She was treated with 500 cc NS, 250 cc NS with 40 M EQ of potassium, and 40 mEq of oral potassium, ceftriaxone.she was a 2 person assist to the commode, and thus was admitted to medicine for further management.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Flank pain, Lymphadenopathy, Pain in extremity, Swelling
Clinical narrative: Patient called today and stated that she developed pain in left arm, armpit and left side  down to around the breast line.  She also stated that she had slight swelling under her arm and side.  I suggested that she follow up with her PCP or go to urgent care.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Burning sensation, Gait disturbance, Illness, Pain
Clinical narrative: I woke up early morning and felt like someone had a hot frying pan on my lower arms, I thought they were Shingles. I had never felt the same feeling before. I swear it felt like it was going into the muscle and at one point I couldn't go to the bathroom because I was in so much pain. I was rocking myself in the couch due to the pain. I'm a phycologist so I was doing all the research and I decided to contact my doctors and they were not so concerned. I felt like I was sick with Flu at level 10, I couldn't walk up and down the steps and my mind couldn't coordinate my steps all the time. I tried walking my dogs and that was even hard. I'm used to running 10K so I tried but It felt like I was going to be like this for ever and about 3 weeks after my vaccination I started feeling okay. The coordination un my body lasted about 3 days. I have seen 3 different doctors because I was concerned with any neurological issues. They couldn't really do anything to treat me. I have contacted my doctor because  I'm not sure about the second vaccine. I got in contact with public health, my doctors got in contact with public health and they pretty much said It was up to me but that they prescribed Prednisone in case I had a worse reaction and to help the inflammatory in my body.  after 3 weeks I was feeling normal so I made the decision to take the second vaccine at that point. Mentally I was pissed because the social media was posting of how it only gives you a sore arm. That wasn't my case.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Fully vaccinated and tested positive for covid-19
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Oral mucosal eruption, Pyrexia, Urticaria
Clinical narrative: Hives covering about 75% of her body (Back, chest, neck, ears, arms, hands, and feet) for 6 days, low grade fever of 101 for first 3 days. On night 2, she had a few spots in her mouth and said her throat was dry. Treatment was benadryl, ibuprofen, cortisone cream, calamine lotion, and ice packs. Resolved on days 6-7.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Muscle spasms
Clinical narrative: I take oral birth control to skip my periods and usually do not experience much breakthrough bleeding. I have been experiencing pretty bad cramping and breakthrough bleeding for 3 weeks non stop at this point.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Supraclavicular lymph gland swelling, pain, low grade fever, fatigue
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node, armpit of my left arm
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Myalgia, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Client vaccinated with Pfizer vaccines in December 2020 and January 2021 at Hospital where he works.  Symptoms started 12/15 - runny nose, myalgia.  Has not received booster vaccine yet.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, SARS-CoV-2 antibody test
Clinical narrative: headaches, backpain, tiredness
Age: 16.0
Sex: F
Vaccine: COVID19, MENB, MNQ
Symptoms: No adverse event
Clinical narrative: No symptoms per Mom.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin sensitisation, Skin warm, Urticaria
Clinical narrative: Extreme bodywide itching, hives. The slightest contact with my skin creates welts and becomes warm.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Fatigue, Feeling abnormal, Heart rate increased
Clinical narrative: A week after the vaccine: chest pain, rapid heart beat, high resting heart rate (lying down makes it go normal rate, sitting elevates it to 80-90bpms, and any standing position causes it to rise 100-110 bpm and stay there, fatigue, and brain fog
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Fall, Syncope
Clinical narrative: Patient received booster dose of Pfizer Covid 19 vaccine. He fell from his seat while at his 15 minute observation. He had a syncope episode which lasted less than 2 minutes. VS WNL. RRT arrived in 3 minutes of being called. Patient was assessed by MD. Patient declined to go to the ER for further evaluation. He remained in the clinic for another 30 minutes and was escorted to his ride home.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Fully vaccinated adult who tested positive for COVID-19
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling in fingers of left hand AND tingling in 3 middle fingertips of RIGHT hand.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Incorrect dose of vaccine given. Patient 10 years old was given 12+ vaccine at 0.2ml volume
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received product 8 days past the beyond use date.  Manufacturer contacted and reviewing product stability.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Fatigue
Clinical narrative: Patient states that during dinner time patient had inability to swallow. Patient also reports fatigue. After two days they were fine
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Fully vaccinated adult tested positive for COVID-19.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Pain in extremity
Clinical narrative: pt was given 0.2ml of the Pfizer adult covid 19 vaccine  dose rather than the pediatric  vaccine.  pt reported a sore arm
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient presented for the COVID-19 booster dose at our clinic on 12/15/21.  Although eligible for the booster dose, she received the incorrect vaccine.  This patient due to her age received the Moderna Booster and should have received the Pfizer booster.  Patient's mother was phoned and spoken to on 12/16/21 at 1600.  I explained the vaccine administration error and the mother was advised to notify her PCP and to notify me (provided my contact information) if her daughter experienced any adverse reactions from the vaccine within the next few weeks or so. Patient's mother did verbalize understanding and her questions and concerns were addressed.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node in left arm
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Urticaria
Clinical narrative: I started getting hives on my lower back and I didn't really pay attention to them at first until I realized there were quite a few. They started bruising. They are on my hips and sides all the way up to under my breasts. I have them every day and I get a new set every day. Since I've had the booster I have also been feel brain fog and I'm not sure why. My hives are concerning because I haven't had them in about 10 years and then the day after the booster they showed up and they won't go away. My allergist believes it was an immune response to the vaccine. She wanted me to try Pepcid AC to get rid of the hives. I have been on it for a week now and I am still getting the hives. I emailed her to ask if there is something else I can take besides prednisone.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles rash on mid back, left side of body, treated with valacylovir
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain, Pyrexia
Clinical narrative: 12 hrs after shot fever 103.5, aches, headache, dizzy.. lasted 42 hours
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Fully vaccinated adult who tested positive for COVID-19
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: On 12/13/21, Patient was seen for administration of her 2nd dose of Moderna covid vaccine, it was noted that the 1st dose administered on 11/29 at another clinic was only 2 weeks prior and not enough time in-between dose #1 and dose #2. Patient was informed of issue and patient advised that her second dose appointment was originally scheduled for 12/27/21, however she needed to be vaccinated sooner for work, so she called to change her appt to a sooner date and was accommodated. The administering Nurse informed the patient that based on CDC guidelines the vaccination would be considered invalid due to timing and she would need to be revaccinated. Management was notified and to following up with patient.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received product 8 days past the beyond use date.  Manufacturer contacted and reviewing product stability.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperacusis, Hyperhidrosis, Pallor, Tunnel vision
Clinical narrative: Patient is here for his booster dose of adult-formulation Pfizer, lot number FJ8757 was received at 1316.  At approximately 1325, he c/o to Post-Vaccination Observation RN that he was feeling lightheaded, had tunnel vision, and rushing sounds in his ears. He presented with pallor and diaphoresis. No LOC was noted, he remained sitting in his chair without issues. His BP at 1331 was 99/56 sitting. He reports that he?s had similar incidents in the past. RN alerted this writer to assist at 1333. This writer encouraged him to lay down on cot, and, at 1334, he self-transferred to the cot, rising and moving without difficulty. His color improved once he laid down and he reported improvement to his s/s. BP at 1339 was 110/62 laying, HR was 55, SPO2 was 100% on RA. He reported that the vision changes, rushing noises, and lightheadedness were resolved upon lying down.  At 1344, he tolerated sitting and standing from cot and was able to self-ambulate to chair without difficulty. At 1344, his BP sitting was 122/58, HR 55, and SPO2 was 100% on RA. At 1345, his BP standing was 118/70, his HR was 56. He was provided education on vasovagal reactions, what to expect, and when to seek out medical care. He reports he will have company with him this evening and was advised to be very cautious when driving and pull over if he started to feel any lightheadedness at all. He verbalized understanding.  His BP at 1350 was 120/70 sitting, HR was 50, and SPO2 was 99% on RA. He denied any further symptoms and reported that he was back to baseline. At 1353, he stood and walked without difficulty and his BP was 117/56 standing, HR was 58, SP02 was 99% on RA. He waited a few additional minutes as a precaution before exiting facility at 1400.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, Chest X-ray, Differential white blood cell count, Electrocardiogram
Clinical narrative: I had the flu shot a week before  i had the booster 15 hours after booster I got shakey, pain in armpit and right breast that went into neck and down my spine. after a week I went to hospital emergency room. still having the same pain in right breast and pain when i take a deep breath or bend over.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer, Full blood count, Influenza virus test, Metabolic function test, Neck pain
Clinical narrative: I had the flu shot a week before  i had the booster 15 hours after booster I got shakey, pain in armpit and right breast that went into neck and down my spine. after a week I went to hospital emergency room. still having the same pain in right breast and pain when i take a deep breath or bend over.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory syncytial virus test, SARS-CoV-2 test, Spinal pain, Tremor, Troponin I
Clinical narrative: I had the flu shot a week before  i had the booster 15 hours after booster I got shakey, pain in armpit and right breast that went into neck and down my spine. after a week I went to hospital emergency room. still having the same pain in right breast and pain when i take a deep breath or bend over.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: pt was given 0.2ml of adult Pfizer covid 19 vaccine rather than the Pediatric Pfizer   no problems reported
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Feeling cold, Hyperhidrosis, Loss of consciousness, Nausea
Clinical narrative: Pharmacist was informed by patient that she has a history of fainting with any injections. Pharmacist had a technician on stand-by to help assist with patient. Patient was talking and fine during the injection. However, soon after her injection was given (around 9:50 am), patient fainted and was unresponsive for about one minute. Since the pharmacist and technician were aware of her history, they were able to prop her up right and stop her from falling off the chair. A cold compress was also placed around her neck. She became responsive again and stated she was seeing "purple dots" in her vision and feeling nauseous. She also stated she had not eaten all day. Water was given to her. A few minutes later, she fainted again and regained consciousness a few seconds after. She then asked to lay down on ground and that she was both cold and hot (sweating) and was experiencing a "tingling" feeling in both her hands. Placed a sweater over her to keep her warm. She asked for us to massage her hands to relieve the "tingling" feeling. She laid on the ground for around 20-30 minutes covered with a sweater and with us massaging her hands. She was also given a Sprite to sip on. She eventually was able to stand up and walk after about 40 minutes post vaccination.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Syncope, Unresponsive to stimuli, Visual impairment
Clinical narrative: Pharmacist was informed by patient that she has a history of fainting with any injections. Pharmacist had a technician on stand-by to help assist with patient. Patient was talking and fine during the injection. However, soon after her injection was given (around 9:50 am), patient fainted and was unresponsive for about one minute. Since the pharmacist and technician were aware of her history, they were able to prop her up right and stop her from falling off the chair. A cold compress was also placed around her neck. She became responsive again and stated she was seeing "purple dots" in her vision and feeling nauseous. She also stated she had not eaten all day. Water was given to her. A few minutes later, she fainted again and regained consciousness a few seconds after. She then asked to lay down on ground and that she was both cold and hot (sweating) and was experiencing a "tingling" feeling in both her hands. Placed a sweater over her to keep her warm. She asked for us to massage her hands to relieve the "tingling" feeling. She laid on the ground for around 20-30 minutes covered with a sweater and with us massaging her hands. She was also given a Sprite to sip on. She eventually was able to stand up and walk after about 40 minutes post vaccination.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Fully vaccinated and tested positive for covid-19
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received product 8 days past the beyond use date.  Manufacturer contacted and reviewing product stability.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Extra dose administered, Headache, Mobility decreased
Clinical narrative: First two shots were Pfizer.  Minor symptoms after both shots including fatigue and arm soreness.  Received Moderna booster on 11/24/21.  Week after had right arm soreness, mild diarrhea and mild headache.  All symptoms resolved.    Two weeks after Moderna shot on 12/8/21 experienced headache, nausea and right arm soreness.  Nausea and headache severe enough to spend 1-2 days in bed.  Arm soreness resolved after 1-2 days.  Headache and nausea continued for 7 days.  Tylenol and ibuprofen did not improve symptoms.  Also experienced lack of appetite, likely due to nausea.  Symptoms resolved for one day (12/15/21).  Then returned today (12/16/21).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: First two shots were Pfizer.  Minor symptoms after both shots including fatigue and arm soreness.  Received Moderna booster on 11/24/21.  Week after had right arm soreness, mild diarrhea and mild headache.  All symptoms resolved.    Two weeks after Moderna shot on 12/8/21 experienced headache, nausea and right arm soreness.  Nausea and headache severe enough to spend 1-2 days in bed.  Arm soreness resolved after 1-2 days.  Headache and nausea continued for 7 days.  Tylenol and ibuprofen did not improve symptoms.  Also experienced lack of appetite, likely due to nausea.  Symptoms resolved for one day (12/15/21).  Then returned today (12/16/21).
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue, Underdose
Clinical narrative: Not enough sterile diluent was added to the vial of Pfizer vaccine prior to administration, therefore patient did not receive enough of the mRNA to qualify as a booster dosage.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Immunisation, Product storage error
Clinical narrative: Patient received expired Moderna vaccine from previous day, the vial was left out in room temperature ~24 hours from first punctured.  A technician who prepared the dose didn't realize that the bottle was used and lukewarm. Notified the patient as as soon as we noticed it and apologized gave replacing dose per CDC recommendations.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received product 8 days past the beyond use date.  Manufacturer contacted and reviewing product stability.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received product 8 days past the beyond use date.  Manufacturer contacted and reviewing product stability.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Erythema, Oral pruritus, Pruritus, Swelling
Clinical narrative: 50mg Benadryl taken prophylactically  at 1030 and again at 1600. At approx 2330 experienced itching in throat and roof of mouth and some shortness of breath. Took another 50mg Benadryl, OTC decongestant and 2 puffs Xopenex MDI.  No relief with worsening symptoms and shortness of breath noted 1 hour later. Took 1 Duoneb nebulizer treatment. Took 1 Duoneb approx 45 minutes after that. Started to feel some relief at that time. Symptoms reappeared mid morning on 12/20/21. Continued regimen of Benadryl, Duoneb and decongestants  in addition to my regular daily medications. Dr.  was contacted on Monday 12/22/2021 and received Prednisone prescription. Attempted to taper Prednisone dose without success. Had symptoms appear as before with addition of swelling, reddened and itchy palms and soles of feet. Re-started Prednisone and am currently doing a very slow taper.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: 50mg Benadryl taken prophylactically  at 1030 and again at 1600. At approx 2330 experienced itching in throat and roof of mouth and some shortness of breath. Took another 50mg Benadryl, OTC decongestant and 2 puffs Xopenex MDI.  No relief with worsening symptoms and shortness of breath noted 1 hour later. Took 1 Duoneb nebulizer treatment. Took 1 Duoneb approx 45 minutes after that. Started to feel some relief at that time. Symptoms reappeared mid morning on 12/20/21. Continued regimen of Benadryl, Duoneb and decongestants  in addition to my regular daily medications. Dr.  was contacted on Monday 12/22/2021 and received Prednisone prescription. Attempted to taper Prednisone dose without success. Had symptoms appear as before with addition of swelling, reddened and itchy palms and soles of feet. Re-started Prednisone and am currently doing a very slow taper.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chills, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Client vaccinated for Covid with Pfizer vaccines on May 26 and June 19, 2021.  Symptoms started on 12/12/2021 - chills, fever 101.2 x 2 days, sore throat.  Probable source is school.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count normal, Metabolic function test, Petechiae, Rash, SARS-CoV-2 test negative
Clinical narrative: petechial rash on chest wall
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received expired Moderna vaccine from previous day, the vial was left out in room temperature ~24 hours from first punctured.  A technician who prepared the dose didn't realize that the bottle was used and lukewarm. Notified the patient as a soon as we noticed it and apologized gave replacing dose per CDC recommendations.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient given 0.2 mL of Adult formulation Pfizer COVID19 vaccine. Correct dosage, incorrect formulation for age of patient. Mother of patient informed, no adverse reaction reported.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Not enough sterile diluent was added to the pfizer vial prior to administration of the booster. It is likely that not enough  was administered to the patient in order to qualify as a booster.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein increased, Chest pain, Echocardiogram normal, Electrocardiogram normal, Full blood count normal
Clinical narrative: Mild chest pain day four post covid vaccine #2.  Evaluated in ED, cardiology and infectious disease consulted.  well appearing  and discharged home from ED with follow up with cardiology.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin increased
Clinical narrative: Mild chest pain day four post covid vaccine #2.  Evaluated in ED, cardiology and infectious disease consulted.  well appearing  and discharged home from ED with follow up with cardiology.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient presented consent form to get Pfizer vaccine but could not find her vaccine record card. Pharmacy had processed her 2 previous doses under 2 different last names. Consent form said only one last name. When we looked up her record in the system, only 1 dose was listed on 9/6/21, so we gave a dose. Patient later found vaccine record card and we saw she had dose 2 on 9/27/21 and had hyphenated name. Booster was too early to give by over 3 months. No adverse events yet reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product administration duration
Clinical narrative: Patient received product 8 days past the beyond use date.  Manufacturer contacted and reviewing product stability.
Age: 68.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral, Hypoaesthesia, Injection site pain, Magnetic resonance imaging head
Clinical narrative: Started having body aches later in day, arm soreness at COVID booster shot area (right arm), slight fever (99) later that night, went to sleep. Woke up around 7:00 AM, and had no hearing, at all, in right ear. Also noticed later that I had lost all feeling inside ear canal and around base of the ear. Later in day, hearing loss was replaced with an extreme amount of ear ringing which appeared to sound like a 40-50 decibel level speaker against the ear. My hearing loss and ringing remain as of this day 12-16-21.
Age: 68.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Pain, Pyrexia, Tinnitus
Clinical narrative: Started having body aches later in day, arm soreness at COVID booster shot area (right arm), slight fever (99) later that night, went to sleep. Woke up around 7:00 AM, and had no hearing, at all, in right ear. Also noticed later that I had lost all feeling inside ear canal and around base of the ear. Later in day, hearing loss was replaced with an extreme amount of ear ringing which appeared to sound like a 40-50 decibel level speaker against the ear. My hearing loss and ringing remain as of this day 12-16-21.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Dyspnoea, Heart rate increased, Pleurisy
Clinical narrative: Chest pain Labored breathing Increased heart rate
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Chest pain Labored breathing Increased heart rate
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient given 0.2mL of adult formulation Pfizer COVID-19 vaccine. Correct dosage, incorrect formulation for age of patient. Mother of patient informed. No adverse reactions reported.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: aches; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches) and PYREXIA (fever) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced PAIN (aches) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, PAIN (aches) and PYREXIA (fever) had not resolved.            High blood pressure medication was given as concomitant.  Company comment: This spontaneous case concerns a 37 year old female with no reported medical history , who experienced non -serious unexpected event of pain and expected event of pyrexia which occurred the day after the vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) . The re-challenge for this case is not applicable since the events were reported as not resolved and the events also occurred after the 3rd dose and no additional doses will be given. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow-up received: Non-significant.; Sender's Comments: This spontaneous case concerns a 37 year old female with no reported medical history , who experienced non -serious unexpected event of pain and expected event of pyrexia which occurred the day after the vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) . The re-challenge for this case is not applicable since the events were reported as not resolved and the events also occurred after the 3rd dose and no additional doses will be given. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Not enough sterile diluent was added to the Pfizer vial prior to administration of the vaccine to the patient. It is likely that the patient did not receive enough MRNA to qualify as a booster dose.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Patient fainted after receiving his first vaccine during his mandatory monitoring period.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Mechanical urticaria, Pruritus, Urticaria
Clinical narrative: I started to experience itchiness of the skin 10 days after my vaccine. Scratching the skin would cause redness and hives. Since then I've gone on Zyrtec daily, which has greatly reduced the itching. However, the reddening of the skin, which was diagnosed as dermatographism, continues.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Sleep disorder
Clinical narrative: Shortness of breath for several hours (better now).  It felt like I was at high altitude. I couldn't sleep because I couldn't seem to catch my breath. I think it was due to extremely intense chills, but it subsided around 4am.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient received the incorrect Pfizer vaccine concentration.  Patient received 12+ rather than 5-11. No untoward events.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Pruritus, Rash
Clinical narrative: Rash appears all the body: there is a big spot around the injection site with a diameter around 2 inches, a 2*4 inches stripe-shaped spot in the lower back, small rash dots appeared majorly in the trunk,  and a few rash dots in the arms. Just a little itchy but totally bearable. No treatment was taken, and symptoms seem to get better after 4-5 days.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Incorrect product formulation administered
Clinical narrative: Not enough sterile diluent was added to the Pfizer vial prior to administration to the patient. It is likely that not enough MRNA was administered to qualify as a booster.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Periorbital oedema, Urticaria
Clinical narrative: Urticaria of entire body, periorbital edema, T102.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Injection site irritation, Injection site pain, Injection site reaction
Clinical narrative: Extreme soreness, weakness, and irritation to injection site that has persisted since 09/28/21.