chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Hypotension, Injection site bruising, Injection site erythema
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Additional Details: Patient fainted shortly after receiving dose one of Pfizer vaccine. Parmedics came, and monitored vitals. They felt his faining was the result of a Vagal nerve response. His mom later explained he often is nervous about needles, receiving shots. I spoke with mom and dad, and let them know I'd be reaching out later in day to check on Patient and submitting the VARES,
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Presyncope, Syncope
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Additional Details: Patient fainted shortly after receiving dose one of Pfizer vaccine. Parmedics came, and monitored vitals. They felt his faining was the result of a Vagal nerve response. His mom later explained he often is nervous about needles, receiving shots. I spoke with mom and dad, and let them know I'd be reaching out later in day to check on Patient and submitting the VARES,
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Additional Details: Patient fainted shortly after receiving dose one of Pfizer vaccine. Parmedics came, and monitored vitals. They felt his faining was the result of a Vagal nerve response. His mom later explained he often is nervous about needles, receiving shots. I spoke with mom and dad, and let them know I'd be reaching out later in day to check on Patient and submitting the VARES,
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site warmth, Monoplegia, Pain, Pain in extremity
Clinical narrative: Swelling, Extreme Pain, heat at the site, electrical pain that radiated down to the hand, temporary paralysis of arm, blurred vision and extreme fatigue.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vision blurred
Clinical narrative: Swelling, Extreme Pain, heat at the site, electrical pain that radiated down to the hand, temporary paralysis of arm, blurred vision and extreme fatigue.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: CDC recommends using single-use vials of normal saline to dilute to each vial of the Pfizer vaccine.  Staff member incorrectly used 100 ml bottles of normal saline to reconstitute multiple vials of vaccine each day.  Staff member used a new bottle per day, however, and used the correct amount of normal saline to dilute each vial (1.8 ml per vial). We have since corrected this error and also notified local health authorities.  Patient has not reported any adverse events to health clinic where error occurred.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bell's palsy, Headache, Visual impairment
Clinical narrative: Systemic: Bell's Palsy-Severe, Systemic: Headache-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: wife came to the pharmacy and explained that after the shot the patient had one side weakness went to er and the er stated that the covid shot was the cause of bells palsy severe headaches, and visual changes. she states that it isnt resolving and they are going for more doctors visits
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Injection site paraesthesia, Injection site pruritus, Malaise
Clinical narrative: Site: Itching at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient described tingling at injection site after dose given.  He became unresponsive within the 15 minute waiting period and was snoring.  I was able to awaken him and he said he was thirsty and not feeling well.  He was diaphoretic, and very pale.  We called 911 and his wife also.  EMS arrived, took his vitals and he seemd to be responding.  His O2 sat was 93 but his color started to come back and he was starting to feel better.  He did not want to go w/ EMS to hospital and signed a waiver.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pallor, Snoring, Syncope, Thirst, Unresponsive to stimuli
Clinical narrative: Site: Itching at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient described tingling at injection site after dose given.  He became unresponsive within the 15 minute waiting period and was snoring.  I was able to awaken him and he said he was thirsty and not feeling well.  He was diaphoretic, and very pale.  We called 911 and his wife also.  EMS arrived, took his vitals and he seemd to be responding.  His O2 sat was 93 but his color started to come back and he was starting to feel better.  He did not want to go w/ EMS to hospital and signed a waiver.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Amnesia, Chills, Electric shock sensation
Clinical narrative: I think it's important to note I had Covid in December/January of 2020/2021.  My first vaccine I had the normal pain at the vaccination location, which was no big deal. By midnight Saturday morning I developed a headache, similar to covid. I has aches, chills, abdominal pain and my fever spiked to 104.9. I also had brain fog again for several days and developed brain "zaps".  They weren't painful, but my brain felt like it was shaking in my skull and I'd kind of forget what was going on at the moment.  These symptoms lasted 6 days, with brain fog and zaps lasting a couple weeks longer.   My second vaccine, I began having symptoms a couple hours later - around 7:00.  It started with stomach pains. By later that evening I had the most severe aches and chills I've ever had. My fever spiked to 105.3 on Saturday and I couldn't open my eyes due to the pain.  I had brain fog and abdominal symptoms as well, but no brain zaps with the second dose. It took 6 days for my fever to go down below 100.4. It remained low grade ( below 100.4) for around 2 weeks total.    My husband called medical facilities when I was having super high fevers and they all said a fever was normal. I've never had a fever of over 104.5 in my life. I couldn't lift my head off the pillow or even open my eyes without pain.  I know aches and chills are typically "unremarkable" side effects, but I've never experienced anything like these,  even even I had covid. My body would shake and I had to move around and my hands and feet were freezing while the rest of my body had a fever over 104.   During my symptom days I took tylenol to mitigate the pain. It brought my fever down to 103 on the high fever days.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Headache, Pain, Peripheral coldness, Pyrexia
Clinical narrative: I think it's important to note I had Covid in December/January of 2020/2021.  My first vaccine I had the normal pain at the vaccination location, which was no big deal. By midnight Saturday morning I developed a headache, similar to covid. I has aches, chills, abdominal pain and my fever spiked to 104.9. I also had brain fog again for several days and developed brain "zaps".  They weren't painful, but my brain felt like it was shaking in my skull and I'd kind of forget what was going on at the moment.  These symptoms lasted 6 days, with brain fog and zaps lasting a couple weeks longer.   My second vaccine, I began having symptoms a couple hours later - around 7:00.  It started with stomach pains. By later that evening I had the most severe aches and chills I've ever had. My fever spiked to 105.3 on Saturday and I couldn't open my eyes due to the pain.  I had brain fog and abdominal symptoms as well, but no brain zaps with the second dose. It took 6 days for my fever to go down below 100.4. It remained low grade ( below 100.4) for around 2 weeks total.    My husband called medical facilities when I was having super high fevers and they all said a fever was normal. I've never had a fever of over 104.5 in my life. I couldn't lift my head off the pillow or even open my eyes without pain.  I know aches and chills are typically "unremarkable" side effects, but I've never experienced anything like these,  even even I had covid. My body would shake and I had to move around and my hands and feet were freezing while the rest of my body had a fever over 104.   During my symptom days I took tylenol to mitigate the pain. It brought my fever down to 103 on the high fever days.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sensory disturbance, Tremor, Vaccination site pain
Clinical narrative: I think it's important to note I had Covid in December/January of 2020/2021.  My first vaccine I had the normal pain at the vaccination location, which was no big deal. By midnight Saturday morning I developed a headache, similar to covid. I has aches, chills, abdominal pain and my fever spiked to 104.9. I also had brain fog again for several days and developed brain "zaps".  They weren't painful, but my brain felt like it was shaking in my skull and I'd kind of forget what was going on at the moment.  These symptoms lasted 6 days, with brain fog and zaps lasting a couple weeks longer.   My second vaccine, I began having symptoms a couple hours later - around 7:00.  It started with stomach pains. By later that evening I had the most severe aches and chills I've ever had. My fever spiked to 105.3 on Saturday and I couldn't open my eyes due to the pain.  I had brain fog and abdominal symptoms as well, but no brain zaps with the second dose. It took 6 days for my fever to go down below 100.4. It remained low grade ( below 100.4) for around 2 weeks total.    My husband called medical facilities when I was having super high fevers and they all said a fever was normal. I've never had a fever of over 104.5 in my life. I couldn't lift my head off the pillow or even open my eyes without pain.  I know aches and chills are typically "unremarkable" side effects, but I've never experienced anything like these,  even even I had covid. My body would shake and I had to move around and my hands and feet were freezing while the rest of my body had a fever over 104.   During my symptom days I took tylenol to mitigate the pain. It brought my fever down to 103 on the high fever days.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early-
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus in left ear
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution-
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: CDC recommends using single-use vials of normal saline to dilute to each vial of the Pfizer vaccine.  Staff member incorrectly used 100 ml bottles of normal saline to reconstitute multiple vials of vaccine each day.  Staff member used a new bottle per day, however, and used the correct amount of normal saline to dilute each vial (1.8 ml per vial). We have since corrected this error and also notified local health authorities.  Patient has not reported any adverse events to health clinic where error occurred.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: patient felt lightheaded after shot. I gave him a water bottle that when he placed on the ground he started to fall over/ lose consiousness. 911 was called immediately.  I was able to catch patient and tried lowering him to the ground as he regained consiousness. cold water was also used to cool neck area. ems took patients bp and wrote up report but patient refused to go to ED. fiance was called to drive home/ to go eat after 30 mins to ensure patient was stable, hydrated.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: CDC recommends using single-use vials of normal saline to dilute to each vial of the Pfizer vaccine.  Staff member incorrectly used 100 ml bottles of normal saline to reconstitute multiple vials of vaccine each day.  Staff member used a new bottle per day, however, and used the correct amount of normal saline to dilute each vial (1.8 ml per vial). We have since corrected this error and also notified local health authorities.  Patient has not reported any adverse events to health clinic where error occurred.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution-
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution-
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Hyperhidrosis, Pain in extremity, Vomiting
Clinical narrative: Arm soreness within an hour.  That night severe stomach cramps, profuse sweating accompanied by diarhea and vomiting.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Pain, Product preparation issue
Clinical narrative: I received the second dose of Pfizer COVID-19 vaccine on Friday, July 23. The next day I woke up with extreme fatigue, dizziness, headache, and aches. On July 26, I received a call from Walgreens stating that I was given a higher concentration of the vaccine due to a dilution error.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: CDC recommends using single-use vials of normal saline to dilute to each vial of the Pfizer vaccine.  Staff member incorrectly used 100 ml bottles of normal saline to reconstitute multiple vials of vaccine each day.  Staff member used a new bottle per day, however, and used the correct amount of normal saline to dilute each vial (1.8 ml per vial). We have since corrected this error and also notified local health authorities. Patient has not reported any adverse events to health clinic where error occurred.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution-
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution-
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Computerised tomogram, Dyspnoea, Electrocardiogram, Joint swelling
Clinical narrative: Symptoms included swelling of both right and left ankles, pain in right leg, shortness of breath 5 days after receiving the vaccine. They put me on oxygen and started administering Lovenox twice a day.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pulmonary embolism, Ultrasound scan, X-ray
Clinical narrative: Symptoms included swelling of both right and left ankles, pain in right leg, shortness of breath 5 days after receiving the vaccine. They put me on oxygen and started administering Lovenox twice a day.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: CDC recommends using single-use vials of normal saline to dilute to each vial of the Pfizer vaccine. Staff member incorrectly used 100 ml bottles of normal saline to reconstitute multiple vials of vaccine each day. Staff member used a new bottle per day, however, and used the correct amount of normal saline to dilute each vial (1.8 ml per vial). We have since corrected this error and also notified local health authorities. Patient has not reported any adverse events to health clinic where error occurred.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Flushing, Hyperhidrosis, Nausea
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Medium, Additional Details: gave shot at 5:54pm, at 6:02pm pt took off mask and complained of being hot and sweaty and nauseous, had pt elevated feet and remain seated, bp#1: 103/73 hr=86 at 6:09pm. bp#2 at 6:21pm 115/76 hr=77, pt left at 6:22pm with issues resolved
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: CDC recommends using single-use vials of normal saline to dilute to each vial of the Pfizer vaccine.  Staff member incorrectly used 100 ml bottles of normal saline to reconstitute multiple vials of vaccine each day.  Staff member used a new bottle per day, however, and used the correct amount of normal saline to dilute each vial (1.8 ml per vial). We have since corrected this error and also notified local health authorities.  Patient has not reported any adverse events to health clinic where error occurred.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears. I went to doctor she took a look in my ears and said they are clear. Next apt is with Audiologist on August 18, 2021.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Dizziness, Musculoskeletal stiffness, Nausea
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Joint Pain-Medium, Additional Details: Patient claims to have had dizziness, stiff neck, nausea, and stomach irritability the following day after administration as well as up through today (7/26/21). Patient has not confirmed symptoms have not ceased as of yet (note: 3 days after administration).
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Joint Pain-Medium, Additional Details: Patient claims to have had dizziness, stiff neck, nausea, and stomach irritability the following day after administration as well as up through today (7/26/21). Patient has not confirmed symptoms have not ceased as of yet (note: 3 days after administration).
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present
Clinical narrative: I was urinating bright red blood.  This was not dark urine, it was blood that was seeping through my underwear.  No other symptoms to report.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Hypotension, Presyncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Additional Details: Patient had a vasovagal response after COVID-19 Vaccine. He was monitored in clinic for over 30 minutes and completely recovered from incident prior to disposition home.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution-
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: CDC recommends using single-use vials of normal saline to dilute to each vial of the Pfizer vaccine. Staff member incorrectly used 100 ml bottles of normal saline to reconstitute multiple vials of vaccine each day. Staff member used a new bottle per day, however, and used the correct amount of normal saline to dilute each vial (1.8 ml per vial). We have since corrected this error and also notified local health authorities. Patient has not reported any adverse events to health clinic where error occurred.
Age: 63.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: pneumoccocal polysaccharide PPV23 on 26-OCT-2017 and pneumoccocal conjugate PCV 13 on 10-OCT-2018; This spontaneous report was received from an adult female patient, concerning to herself via medical record from a case in litigation for zoster vaccine live (ZOSTAVAX) (Marrs# 2103USA001618). The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.      On 26-OCT-2017, the patient was vaccinated with pneumococcal polysaccharide PPV23 (manufacturer unknown) for prophylaxis with a dose of 0.5 mL, administered in the right deltoid , lot number N020502, expiration date 08-FEB-2019 (strength and route of administration was not provide) .It was reported that another doses of pneumococcal conjugate PCV13 pneumococcal vaccine, polyvalent  for prophylaxis, with a dose of 0.5 mL, administered in the left deltoid, intramuscular, lot number W33491 (strength and expiration date was not provided) was administered on 10-OCT-2018 (inappropriate schedule of product administration).   This is one of two reports received from the same patient. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: N020502; expirationdate: 08-FEB-2019; deviceage and unit: 0 ; operatorofdevice: Licensed Practical Nurse; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2103USA001618:
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: CDC recommends using single-use vials of normal saline to dilute to each vial of the Pfizer vaccine.  Staff member incorrectly used 100 ml bottles of normal saline to reconstitute multiple vials of vaccine each day.  Staff member used a new bottle per day, however, and used the correct amount of normal saline to dilute each vial (1.8 ml per vial). We have since corrected this error and also notified local health authorities.  Patient has not reported any adverse events to health clinic where error occurred.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: CDC recommends using single-use vials of normal saline to dilute to each vial of the Pfizer vaccine.  Staff member incorrectly used 100 ml bottles of normal saline to reconstitute multiple vials of vaccine each day.  Staff member used a new bottle per day, however, and used the correct amount of normal saline to dilute each vial (1.8 ml per vial). We have since corrected this error and also notified local health authorities.  Patient has not reported any adverse events to health clinic where error occurred.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: CDC recommends using single-use vials of normal saline to dilute to each vial of the Pfizer vaccine.  Staff member incorrectly used 100 ml bottles of normal saline to reconstitute multiple vials of vaccine each day.  Staff member used a new bottle per day, however, and used the correct amount of normal saline to dilute each vial (1.8 ml per vial). We have since corrected this error and also notified local health authorities.  Patient has not reported any adverse events to health clinic where error occurred.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Ultrasound Doppler abnormal
Clinical narrative: DVT is right leg
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Muscle tightness
Clinical narrative: Patient began to have metallic taste in mouth - felf like "he had braces on again." Also felt slight tightness in his cheeks.  Dispensed 1 loratadine per patient request (his allergist told him to take one when he has signs of reaction), and shortly after administered 50mg benadryl liquid to the patient. Sat with patient for 45 minutes after administration, to which all symptoms resolved and patient stated they were ready to go, and they left.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: CDC recommends using single-use vials of normal saline to dilute to each vial of the Pfizer vaccine.  Staff member incorrectly used 100 ml bottles of normal saline to reconstitute multiple vials of vaccine each day.  Staff member used a new bottle per day, however, and used the correct amount of normal saline to dilute each vial (1.8 ml per vial). We have since corrected this error and also notified local health authorities.  Patient has not reported any adverse events to health clinic where error occurred.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Laryngoscopy, Vocal cord paralysis
Clinical narrative: My vocal chord on left side is paralyzed.  I became hoarse about a week after vaccine and went to Dr a month later when voice had not returned.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: CDC recommends using single-use vials of normal saline to dilute to each vial of the Pfizer vaccine.  Staff member incorrectly used 100 ml bottles of normal saline to reconstitute multiple vials of vaccine each day.  Staff member used a new bottle per day, however, and used the correct amount of normal saline to dilute each vial (1.8 ml per vial). We have since corrected this error and also notified local health authorities.  Patient has not reported any adverse events to health clinic where error occurred.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: BILATERAL HAND SWELLING AND ITCHING
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Antiphospholipid antibodies negative, Arthralgia, Borrelia test negative, C-reactive protein normal, Myalgia
Clinical narrative: About a month later, I began to develop joint and muscle pains throughout my body (lower back, hips, elbows, wrists, lower neck and ankles).
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Headache, Pain in extremity, Pulmonary pain, Renal pain
Clinical narrative: Pain in arm, pain in back, headaches, pain in kidney, pain in lung, minor spotting on wrist.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: CDC recommends using single-use vials of normal saline to dilute to each vial of the Pfizer vaccine.  Staff member incorrectly used 100 ml bottles of normal saline to reconstitute multiple vials of vaccine each day.  Staff member used a new bottle per day, however, and used the correct amount of normal saline to dilute each vial (1.8 ml per vial). We have since corrected this error and also notified local health authorities.  Patient has not reported any adverse events to health clinic where error occurred.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Adenocarcinoma, Death
Clinical narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Likely comorbidities that were related to death were adenocarcinoma and possible stroke symptoms.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Syringe issue
Clinical narrative: none. it was a syringe failure. inject into the Left deltoid and the plunger will not pushed in. when force, the needle retract and the vaccine was seen on the outside of the arm instead of inside the arm.  She may have gotten a possible < 0.1ml of vaccine.  as per patient, she wants to get it over with so we gave her the full dose (0.3ml) into the Right deltoid . she waited the standard 15 mins and has no adverse reaction.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Hepatic encephalopathy, Liver disorder
Clinical narrative: Death 7-23-21
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope
Clinical narrative: Dizziness, complete syncope.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness
Clinical narrative: Ongoing dizziness and loss of stability at times.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Urticaria
Clinical narrative: a week after treatment started breaking out in hives and face swelling; experience on and off for last two weeks
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Heart rate decreased, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: About five minutes after injection, patient began to lose consciousness. Blood pressure dropped and patient sweated profusely. Pulse was also very low. Patient was difficult to rouse for several minutes. Mother is a medical professional and she was monitoring patient. EMS was called and patient evaluated about 10 minutes after injection. At that time patient was coming around but still very pale with low blood pressure.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood glucose increased, Death, Full blood count, Metabolic function test normal, Pulseless electrical activity
Clinical narrative: patient arrived in ventricular tachycardia via EMS, but responsive. deteoriarated to pulseless ventricular tachycardia, PEA and ultimately death.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Ventricular tachycardia
Clinical narrative: patient arrived in ventricular tachycardia via EMS, but responsive. deteoriarated to pulseless ventricular tachycardia, PEA and ultimately death.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Autopsy, Death, Myocarditis
Clinical narrative: patient arrived in ventricular tachycardia via EMS, but responsive. deteoriarated to pulseless ventricular tachycardia, PEA and ultimately death.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alanine aminotransferase normal, Anion gap increased, Aspartate aminotransferase increased, Blood albumin decreased, Blood alkaline phosphatase normal
Clinical narrative: patient arrived in ventricular tachycardia via EMS, but responsive. deteoriarated to pulseless ventricular tachycardia, PEA and ultimately death.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood bilirubin normal, Blood chloride normal, Blood creatinine normal, Blood glucose increased, Blood potassium decreased
Clinical narrative: patient arrived in ventricular tachycardia via EMS, but responsive. deteoriarated to pulseless ventricular tachycardia, PEA and ultimately death.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood sodium normal, Blood urea normal, Carbon dioxide decreased, Cardioversion, Death
Clinical narrative: patient arrived in ventricular tachycardia via EMS, but responsive. deteoriarated to pulseless ventricular tachycardia, PEA and ultimately death.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Feeling abnormal, Full blood count, Haematocrit normal
Clinical narrative: patient arrived in ventricular tachycardia via EMS, but responsive. deteoriarated to pulseless ventricular tachycardia, PEA and ultimately death.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Haemoglobin normal, Loss of consciousness, Metabolic function test, Nausea, Platelet count normal
Clinical narrative: patient arrived in ventricular tachycardia via EMS, but responsive. deteoriarated to pulseless ventricular tachycardia, PEA and ultimately death.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Resuscitation, SARS-CoV-2 test negative, Supraventricular tachycardia, Unresponsive to stimuli, Vomiting
Clinical narrative: patient arrived in ventricular tachycardia via EMS, but responsive. deteoriarated to pulseless ventricular tachycardia, PEA and ultimately death.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: White blood cell count normal
Clinical narrative: patient arrived in ventricular tachycardia via EMS, but responsive. deteoriarated to pulseless ventricular tachycardia, PEA and ultimately death.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Asthenia, COVID-19, COVID-19 pneumonia, Confusional state
Clinical narrative: 7/24/21: past 3-4 days, patient had low energy, decreased appetite, drinking very little, and more confused than his baseline. Patient weak and breathing quickly, so came in to ED. found to be COVID positive. Diagnosed with: COVID-19 pneumonia, acute hypoxic resp failure, shortness of breath, acute encephalopathy. Note: patent previously vaccinated with COVID-19 vaccine in April 2021. 7/27: patient still admitted at the time of this form submission.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Dyspnoea, Encephalopathy, Fluid intake reduced, Respiratory rate increased
Clinical narrative: 7/24/21: past 3-4 days, patient had low energy, decreased appetite, drinking very little, and more confused than his baseline. Patient weak and breathing quickly, so came in to ED. found to be COVID positive. Diagnosed with: COVID-19 pneumonia, acute hypoxic resp failure, shortness of breath, acute encephalopathy. Note: patent previously vaccinated with COVID-19 vaccine in April 2021. 7/27: patient still admitted at the time of this form submission.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: 7/24/21: past 3-4 days, patient had low energy, decreased appetite, drinking very little, and more confused than his baseline. Patient weak and breathing quickly, so came in to ED. found to be COVID positive. Diagnosed with: COVID-19 pneumonia, acute hypoxic resp failure, shortness of breath, acute encephalopathy. Note: patent previously vaccinated with COVID-19 vaccine in April 2021. 7/27: patient still admitted at the time of this form submission.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: CDC recommends using single-use vials of normal saline to dilute to each vial of the Pfizer vaccine.  Staff member incorrectly used 100 ml bottles of normal saline to reconstitute multiple vials of vaccine each day.  Staff member used a new bottle per day, however, and used the correct amount of normal saline to dilute each vial (1.8 ml per vial). We have since corrected this error and also notified local health authorities.  Patient has not reported any adverse events to health clinic where error occurred.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 13 year old received the Jansen vaccine.  Spoke to parent on 7/19/2021.  Parent stated that he had a fever of 102 degree Fahrenheit for about 6 hours and felt achy for about 24 hours.  She stated he was doing fine and had been doing yard work.  Spoke to parent on 7/23/21.  I informed her that he did not need an additional vaccine.  She thanked me for calling.  She said he was still doing fine and was currently away at camp.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling of body temperature change, Headache, Influenza like illness, Myalgia
Clinical narrative: Full on flu-like symptoms: body aches, fever, feeling hot/cold, headache, muscle ache, tiredness. Sore arm.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Full on flu-like symptoms: body aches, fever, feeling hot/cold, headache, muscle ache, tiredness. Sore arm.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient was given Pentacel but should have been given Hib only.  Immunization Program was called and they said that no harm in patient receiving the "extra" doses of Dtap and Polio) and to keep an eye on patient's symptoms in terms of typical vaccine side effects. Patient's mother informed.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Blood potassium decreased, Blood test abnormal, Chest X-ray normal, Electrocardiogram normal, Scan brain
Clinical narrative: One day after receiving my first dose of the Pfizer COVID-19 vaccine, I fainted and felt like I was dying. I was taken to the ER via ambulance.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: One day after receiving my first dose of the Pfizer COVID-19 vaccine, I fainted and felt like I was dying. I was taken to the ER via ambulance.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: CDC recommends using single-use vials of normal saline to dilute to each vial of the Pfizer vaccine.  Staff member incorrectly used 100 ml bottles of normal saline to reconstitute multiple vials of vaccine each day.  Staff member used a new bottle per day, however, and used the correct amount of normal saline to dilute each vial (1.8 ml per vial). We have since corrected this error and also notified local health authorities.  Patient has not reported any adverse events to health clinic where error occurred.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site pain, Musculoskeletal stiffness, Vomiting
Clinical narrative: vomiting, stiffness in neck, soreness at injection site
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Swollen tongue
Clinical narrative: sudden onset facial and tongue swelling
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Fully vaccinated. Diagnosed with COVID 7/26/2021
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: CDC recommends using single-use vials of normal saline to dilute to each vial of the Pfizer vaccine.  Staff member incorrectly used 100 ml bottles of normal saline to reconstitute multiple vials of vaccine each day.  Staff member used a new bottle per day, however, and used the correct amount of normal saline to dilute each vial (1.8 ml per vial). We have since corrected this error and also notified local health authorities.  Patient has not reported any adverse events to health clinic where error occurred.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy breast abnormal, Breast cancer female, Breast enlargement, Computerised tomogram, Inflammatory carcinoma of the breast
Clinical narrative: Breast cancer.  Received first dose in left arm on April 26, 2021 with no signs or symptoms. On May 6, noticed an increase in size of my right breast and tender lymph nodes in my right arm pit. May 10 I was seen by my gynecologist and immediately recommended to have a mammogram. May 12 I had the mammogram, May 13 a biopsy was done. May 19 I was verbally told I had inflammatory mammary carcinoma.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Mammogram
Clinical narrative: Breast cancer.  Received first dose in left arm on April 26, 2021 with no signs or symptoms. On May 6, noticed an increase in size of my right breast and tender lymph nodes in my right arm pit. May 10 I was seen by my gynecologist and immediately recommended to have a mammogram. May 12 I had the mammogram, May 13 a biopsy was done. May 19 I was verbally told I had inflammatory mammary carcinoma.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Asthenia, COVID-19, COVID-19 pneumonia, Cough
Clinical narrative: 7/23/21: came to the ED with generalized weakness and cough with low oxygen levels with hx of COPD. admitted with COVID-19 pneumonia, acute renal failure, hypoxemia Note: patient previously vaccinated with Pfizer COVID-19 vaccine on:  1/26/2021 and 2/23/2021.  Lot numbers EL1283 and EL9269 7/27/21: patient still admitted at the time of this report submission.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia, Oxygen saturation decreased, SARS-CoV-2 test positive
Clinical narrative: 7/23/21: came to the ED with generalized weakness and cough with low oxygen levels with hx of COPD. admitted with COVID-19 pneumonia, acute renal failure, hypoxemia Note: patient previously vaccinated with Pfizer COVID-19 vaccine on:  1/26/2021 and 2/23/2021.  Lot numbers EL1283 and EL9269 7/27/21: patient still admitted at the time of this report submission.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Ear pain
Clinical narrative: PT is a 39 y.o. male who presents to the ED with complaints of left ear pain upon awakening this morning.  Patient reports constant pressure inside his left ear.  Patient describes a "popping" sensation when he opens and closes his mouth. Patient recently underwent left superficial parotidectomy for pleomorphic adenoma on 07/09/2021 (ENT).  Patient states he was recently cleared from surgery to start showering.  Patient states swelling postoperatively was initially hard but has softened and increased over the past few days.  Patient reports that he did receive his 1st COVID vaccine on 07/23/2021.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oropharyngeal pain, Tonsillar hypertrophy
Clinical narrative: Swelling and pain of bilateral tonsils, lymph  nodes in the neck, armpits, breast and groin that has lasted 5 days and is ongoing
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Electromyogram, Hypoaesthesia, Immediate post-injection reaction, Muscular weakness, Nerve conduction studies
Clinical narrative: numbness, tingling, and weakness of arm.  Started immediately after vaccination.  Got worse over the next couple of weeks and then has slowly started to get better without intervention
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: numbness, tingling, and weakness of arm.  Started immediately after vaccination.  Got worse over the next couple of weeks and then has slowly started to get better without intervention
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Audiogram abnormal, Deafness bilateral, Deafness neurosensory, Magnetic resonance imaging, Scan with contrast
Clinical narrative: Patient had  the Pfizer Covid vaccine Wednesday, July 21 around 4:45pm. (This was received at a local pharmacy, I did reach out to them and they confirmed the injection and provided additional vaccine information.) The next morning he woke with tinnitus and hearing loss in the right ear. Seen in the ENT clinic on July 26. Audiogram done that day showed moderate to severe sensorineural hearing loss in the right ear. Mild hearing loss in the left. No previous audio for comparison but patient states he has had no previous problems with his hearing, tinnitus or previous otologic surgeries. Also symptoms of tinnitus which he described as a loud, constant humming sound. No history of tinnitus prior to the loss. Of note he takes prn sildenafil but had not taken any in the weeks leading up to the hearing loss. Seen in the clinic on 7-26-2021. Started on a high dose prednisone tapper and MRI with IAC pending. Plan to see him back in the clinic in one month with an audiogram.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Patient had  the Pfizer Covid vaccine Wednesday, July 21 around 4:45pm. (This was received at a local pharmacy, I did reach out to them and they confirmed the injection and provided additional vaccine information.) The next morning he woke with tinnitus and hearing loss in the right ear. Seen in the ENT clinic on July 26. Audiogram done that day showed moderate to severe sensorineural hearing loss in the right ear. Mild hearing loss in the left. No previous audio for comparison but patient states he has had no previous problems with his hearing, tinnitus or previous otologic surgeries. Also symptoms of tinnitus which he described as a loud, constant humming sound. No history of tinnitus prior to the loss. Of note he takes prn sildenafil but had not taken any in the weeks leading up to the hearing loss. Seen in the clinic on 7-26-2021. Started on a high dose prednisone tapper and MRI with IAC pending. Plan to see him back in the clinic in one month with an audiogram.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Injection site erythema, Injection site pain, Injection site swelling, Rash
Clinical narrative: Injection site is red, swollen and tender to touch.  Started breaking out in patches close to wrist and four close to elbow.  Ruby red in color and painful, shortness of breath.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Injection site is red, swollen and tender to touch.  Started breaking out in patches close to wrist and four close to elbow.  Ruby red in color and painful, shortness of breath.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Hypersensitivity, Urinary tract infection
Clinical narrative: ** Began coughing in mid March after spending extended time in hot Florida sun. Coughing continued for approximately five weeks. Along with onset of coughing also developed a urinary-track infection.  Visited Dr., my PCP, April 23. I would have seen him earlier, but he was on vacation. I did do a Tele visit with Dr., in late March, who prescribed medicine for the urinary infection. By this time the coughing had subsided, so I did not seek her help with that issue. Subsequently, coughing started again. When I visited Dr. in April, he felt that the coughing was triggered by an allergic reaction and possibly by acid reflux. He prescribed medication to treat the allergies. I also took an OTC drug for acid reflux. The coughing stopped a short time later.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, C-reactive protein increased, Condition aggravated, Deafness unilateral, Haemorrhage
Clinical narrative: About 4 hours after the second dose I began the most intense headache I have ever had.  I kept expecting it to go away.  After 10 days of enduring this I went to the ER.  I was admitted with blood clots and bleeding from the face. (but probably more wrong)  I was initially treated for a PE and meds to try to stop the headache.  Nothing seemed to work.  About 3 days into the hospital stay, my pre-existing Stills disorder began to show.  I was then treated with 60mg of prednisone daily to control the Stills.  About the same time, we discovered that a standard migraine medicine would control the extreme headache, morphine would not.  My CRP results were off the charts and almost 4 months later it is still high.  My treating doc says 2 more months of prednisone treatment.  I had an immediate weight loss of 25 pounds in the hospital.  I am struggling to this day to put the weight back on.  I have lost hearing in my left ear as a result.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pulmonary embolism, Still's disease, Thrombosis, Weight decreased
Clinical narrative: About 4 hours after the second dose I began the most intense headache I have ever had.  I kept expecting it to go away.  After 10 days of enduring this I went to the ER.  I was admitted with blood clots and bleeding from the face. (but probably more wrong)  I was initially treated for a PE and meds to try to stop the headache.  Nothing seemed to work.  About 3 days into the hospital stay, my pre-existing Stills disorder began to show.  I was then treated with 60mg of prednisone daily to control the Stills.  About the same time, we discovered that a standard migraine medicine would control the extreme headache, morphine would not.  My CRP results were off the charts and almost 4 months later it is still high.  My treating doc says 2 more months of prednisone treatment.  I had an immediate weight loss of 25 pounds in the hospital.  I am struggling to this day to put the weight back on.  I have lost hearing in my left ear as a result.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching on various parts of body, stomach, neck, legs. No rash or redness.