chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event-Medication error Moderna booster given too soon. Second dose was given 6/9/2021, so it had not been 6 months.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administration error, Wrong product administered
Clinical narrative: No adverse event-- administration error- the patient should have received Pfizer (first dose of COVID vaccine unknown), at our clinic for 2nd dose
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: ADMINISTRATION OF IMPROPERLY STORED VACCINES
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: ADMINISTRATION OF PROPERLY STORED VACCINES
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pediatric patient received vaccine indicated for ages 12 and up.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: 70 doses of Pfizer-BioNTech COVID-19 vaccine for pediatric patients (orange cap) batch/lot# FK5618 assigned a beyond-use-date (BUD, do not use after date) by the manufacturer due to previous storage and handling issues at another facility. The doses mistakenly administered to 70 patients on 11/26/2021.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: administration of improperly stored vaccines
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administration of improperly stored vaccines
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient was 12 years old at time of vaccination but received Pfizer dosage (10mcg/0.2mL) of vaccine for 2nd dose. Patient should have received regular Pfizer vaccine (30mcg/0.3mL) dosage.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: on and off rash, itching, hives
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: ADMINISTRATION OF IMPROPERLY STORED VACCINES
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Angiogram abnormal, Cardiac imaging procedure abnormal, Chest pain, Troponin increased
Clinical narrative: Patient developed chest pain within 4 hours of booster shot. She presented to the hospital 11/8/21 and was found to have elevated troponin. Diagnosed with NSTEMI without any evidence of underlying CAD on cardiac work-up.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: 5mins post vaccination pt reported "trouble breathing".  Mother believes its related to wearing a mask.  Pt taken to med bay.  No S/S of respiratory distress.  VSS.  Pt feeling better once mask is removed.  NO swelling tongue or lips.  Lung sounds clear. Symptoms subsided once mask was removed.  Pt released in stable condition.  Strong steady gait.  Instructed mother to call emergency services if pt has s/s resp distress. Vitals: 17:35 115/71, 82, 28, 100%
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pain, Tenderness, Ultrasound scan abnormal
Clinical narrative: Three days (Oct. 15) after my booster shot on Oct. 12  when I also received the FLU SHOT on the same day in my right arm, I had shooting pain down my left leg. I thought it was another episode of sciatic nerve pain and took some pain medication (at nights) to help allivieate the pain. I went in for my physical therapy appointment on Oct. 18 when I complained about the pain immediately behind my left knee. My therapist said that was not common for sciatic nerve pain and because of the tenderness wondered if I may have developed a clot. She called my physician who asked me to get to the ER/Urgent Care to get an echo of the leg and cancelled the rest of my PT appointment.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Rash vesicular
Clinical narrative: I began to have pain along my right thorax and then began to have a vesicular rash about 3 days later. I took OTC ibuprofen and received treatment with valacyclovir & gabapentin. After about a week, all symptoms subsided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bone pain, Bone swelling, Chest pain, Computerised tomogram neck
Clinical narrative: 11-6-2021:  1st dose I had a sore arm and swelling down the arm to my hand, some nausea periodically but seemed to be OK 11-27-2021:  2nd dose, within 20 minutes left side of my neck had a bit of swelling - Pharmacist provided Benadryl continued to take through the evening on Saturday.   11-28-2021:  Sunday completely fatigued and through the night stiffness in my left side set in through my entire neck, back, throat and pain all along my collarbone, swelling in the collarbone and along with swelling in the vein.  Pain across the chest.  All issues were contained on my left side.  Nothing on the right side. 11-29-2021:  Woke to extreme fatigue, slow breathing, weakness and swelling was getting worse... pain was increasing.  Went to the hospital midday around 12P to 1PM.  Had to wait to see a doctors for close to 3 hours.  Started in Emergency moved to ICU details below 11-30-2021:  Released from ICU.   12-1-2021:  Recovering at home from all the treatments.  Recommended to take benadryl, as needed and follow-up
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Intensive care, Laryngeal stenosis, Musculoskeletal stiffness, Respiratory rate decreased
Clinical narrative: 11-6-2021:  1st dose I had a sore arm and swelling down the arm to my hand, some nausea periodically but seemed to be OK 11-27-2021:  2nd dose, within 20 minutes left side of my neck had a bit of swelling - Pharmacist provided Benadryl continued to take through the evening on Saturday.   11-28-2021:  Sunday completely fatigued and through the night stiffness in my left side set in through my entire neck, back, throat and pain all along my collarbone, swelling in the collarbone and along with swelling in the vein.  Pain across the chest.  All issues were contained on my left side.  Nothing on the right side. 11-29-2021:  Woke to extreme fatigue, slow breathing, weakness and swelling was getting worse... pain was increasing.  Went to the hospital midday around 12P to 1PM.  Had to wait to see a doctors for close to 3 hours.  Started in Emergency moved to ICU details below 11-30-2021:  Released from ICU.   12-1-2021:  Recovering at home from all the treatments.  Recommended to take benadryl, as needed and follow-up
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Spinal X-ray, Swelling, Vein disorder
Clinical narrative: 11-6-2021:  1st dose I had a sore arm and swelling down the arm to my hand, some nausea periodically but seemed to be OK 11-27-2021:  2nd dose, within 20 minutes left side of my neck had a bit of swelling - Pharmacist provided Benadryl continued to take through the evening on Saturday.   11-28-2021:  Sunday completely fatigued and through the night stiffness in my left side set in through my entire neck, back, throat and pain all along my collarbone, swelling in the collarbone and along with swelling in the vein.  Pain across the chest.  All issues were contained on my left side.  Nothing on the right side. 11-29-2021:  Woke to extreme fatigue, slow breathing, weakness and swelling was getting worse... pain was increasing.  Went to the hospital midday around 12P to 1PM.  Had to wait to see a doctors for close to 3 hours.  Started in Emergency moved to ICU details below 11-30-2021:  Released from ICU.   12-1-2021:  Recovering at home from all the treatments.  Recommended to take benadryl, as needed and follow-up
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, Vision blurred
Clinical narrative: Blurred vision and double vision
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: ADMINISTRATION OF IMPROERLY STORED VACCINES
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: 70 doses of Pfizer-BioTech Covid Vaccine for pediatric patients (orange cap) Lot FK5618 were delivered assigned a beyond use date (BUD, do not use after date) by the manufacturer due to previous storage and handling issues at another facility.  The doses were mistakenly administered to 70 patients on 11/26/21
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Presyncope, Syncope
Clinical narrative: PATIENT DEVELOPED VASOVAGAL REACTION (FAINTED).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administration of improperly stored vaccines.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Flushing, Oropharyngeal pain, Paraesthesia, Sensation of foreign body
Clinical narrative: I got my shot at 1:05pm. 15-20 min later as I was leaving vaccination site, I felt throat tightness (like the feeling of a sore throat), left earlobe felt swollen, lower left of face felt tingly and swollen. My face felt flush. 5 min later symptoms went away on its own- face no longer felt swollen, but throat still felt tight/ like a lump in my throat. Around 6:30pm I felt throat tightness more pronounced plus feet tingling. I took Benadryl 50mg dose and throat tightness/ lump went away. I fell alseep around 9 pm and no longer felt any of these symptoms in the morning.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Throat tightness
Clinical narrative: I got my shot at 1:05pm. 15-20 min later as I was leaving vaccination site, I felt throat tightness (like the feeling of a sore throat), left earlobe felt swollen, lower left of face felt tingly and swollen. My face felt flush. 5 min later symptoms went away on its own- face no longer felt swollen, but throat still felt tight/ like a lump in my throat. Around 6:30pm I felt throat tightness more pronounced plus feet tingling. I took Benadryl 50mg dose and throat tightness/ lump went away. I fell alseep around 9 pm and no longer felt any of these symptoms in the morning.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: None--- submitting form because patient should have received Pfizer (age) instead of Moderna. Patient is doing well
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: administration of improperly stored vaccines
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Diarrhoea, Ear discomfort, Fatigue, Flushing
Clinical narrative: Within 24 hours of getting the shot, patient felt flush, fatigued, nauseous, along with diarrhea. In addition to these, patient also had pressure in both ears. 72 hours after the shot was administered, most of the side effects had subsided. The pressure in the ears continued along with a constant, loud and deep humming tone. As this report is being filled out, 12 days after the injection, patient is still complains of ear pressure, loss of hearing, and the load tone.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Tinnitus
Clinical narrative: Within 24 hours of getting the shot, patient felt flush, fatigued, nauseous, along with diarrhea. In addition to these, patient also had pressure in both ears. 72 hours after the shot was administered, most of the side effects had subsided. The pressure in the ears continued along with a constant, loud and deep humming tone. As this report is being filled out, 12 days after the injection, patient is still complains of ear pressure, loss of hearing, and the load tone.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Mixed deafness, Sensory disturbance, Tinnitus
Clinical narrative: Within 24 hours of getting the shot, patient felt flush, fatigued, nauseous, along with diarrhea. In addition to these, patient also had pressure in both ears. 72 hours after the shot was administered, most of the side effects had subsided. The pressure in the ears continued along with a constant, loud and deep humming tone. As this report is being filled out, 12 days after the injection, patient is still complains of ear pressure, loss of hearing, and the load tone.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Pain in extremity, Walking aid user
Clinical narrative: On approximately 3/22/21 right thigh pain started. This increased to difficulty walking. Resulting in the need for an additional cane and a walker. Pain rates from 3 to 6 depending on the day.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram normal, Headache, Loss of personal independence in daily activities, Migraine, Vertigo
Clinical narrative: Got a terrible migraine 8 hours after getting my vaccine. The migraine lasted for a week until I could get a toridol shot. Hospitals didn't know what to do and neither did doctors. The migraines continue every day at this point. They were happening every 20 days and would only go away with a toridol shot. Now they continue daily and will not subside with toridol or any migraine medication. I have had two ER visits, 15-20 doctors visits and my life has been completely altered as I can barely get through the day. I've spent thousands of dollars to try to heal and get answers. I can not get any answers. I also had to get a cat scan to look for a blood clot. No blood clot found but the headaches will not stop, virtigo included. BEFORE I GOT THIS VACCINE, I'VE NEVER HAD A MIGRAINE IN MY Life.  They have gotten progressively worse over time.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Impaired quality of life, Migraine
Clinical narrative: Got a terrible migraine 8 hours after getting my vaccine. The migraine lasted for a week until I could get a toridol shot. Hospitals didn't know what to do and neither did doctors. The migraines continue every day at this point. They were happening every 20 days and would only go away with a toridol shot. Now they continue daily and will not subside with toridol or any migraine medication. I have had two ER visits, 15-20 doctors visits and my life has been completely altered as I can barely get through the day. I've spent thousands of dollars to try to heal and get answers. I can not get any answers. I also had to get a cat scan to look for a blood clot. No blood clot found but the headaches will not stop, virtigo included. BEFORE I GOT THIS VACCINE, I'VE NEVER HAD A MIGRAINE IN MY Life.  They have gotten progressively worse over time.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Back pain, Dizziness, Dyspepsia, Hot flush
Clinical narrative: Intense back pain for 3 weeks, ears ringing, heartburn daily (tums and bland diet did not help), tingling in arms legs and head. Hot flashes. Swollen lymph node developed on base of neck on left side that has not gone away yet 5 weeks later. Tender sore underarm and breasts for 5 weeks. Dizzy, lightheaded immediately after and for weeks after.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Paraesthesia, Tinnitus, Ultrasound Doppler abnormal
Clinical narrative: Intense back pain for 3 weeks, ears ringing, heartburn daily (tums and bland diet did not help), tingling in arms legs and head. Hot flashes. Swollen lymph node developed on base of neck on left side that has not gone away yet 5 weeks later. Tender sore underarm and breasts for 5 weeks. Dizzy, lightheaded immediately after and for weeks after.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose decreased, Extra dose administered
Clinical narrative: Issues with blood sugar levels. Had issue 2 weeks after 2nd dose and am having same issue 2 weeks after booster dose. Eating same meal for lunch every day that I've been eating for months and have issues with my sugar dropping below 70. Lasted for a week after 2nd dose and is now on day 2 of low sugar during midday / afternoon after booster shot.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Lower respiratory tract infection, Nasopharyngitis, SARS-CoV-2 test negative
Clinical narrative: Lose of taste and smell, chest and head congestion all beginning  11/29/2021.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Neck pain
Clinical narrative: Pt developed left arm pain soon after receiving vaccine (11/10/21) and then woke the following morning (11/11/21) at 0400 with severe left-sided neck pain. Pt was inconsolable. Pain went away with time, heat and Advil.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: administration of improperly stored vaccines
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Urinary tract infection, Urine analysis abnormal
Clinical narrative: I had extreme fatigue. I went to the doctor on 11/26/2021. They said I had an urinary track infection. I was prescribed antibiotics for nitrofurantoin 100mg 2xday for 7 days.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Chest pain, Hypokinesia, Pain, Stress echocardiogram
Clinical narrative: Started with arrhythmias. Then severe chest pain. This went on for weeks with severe pain like my heart was being squeezed. It would last for hours. I thought it might be stress-related. When it didn't go away, I contacted my doctor. I had COVID-19 months prior. I was still antibody positive when I got the Moderna shot. I am very physically active and eat mostly a clean diet.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: 70 doses of Pfizer-BioNTech COVID-19 vaccine for pediatric patients (orange cap) batch/lot# FK5618  assigned a beyond-use-date (BUD, do not use after date) by the manufacturer due to previous storage and handling issues at another facility. The doses mistakenly administered to 70 patients on 11/26/2021.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administration of improperly stored vaccine.
Age: 70.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Chest discomfort, Pain in extremity
Clinical narrative: 11/30/2021 Patient reported heat on her chest and pain in left hand 6/10 15 minutes post flu vaccine and Pfizer booster. Rapid Response team activated. Vital signs and reported symptoms monitored continuously for 1.5hrs in clinic. Symptoms resolved and patient was released to self care. Telehealth visit f/u complete by provider 12/1/2021. Per note full resolution of symptoms.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administration of improperly stored vaccines
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administration of improperly stored vaccines.
Age: 32.0
Sex: M
Vaccine: FLUR4
Symptoms: Wrong product administered
Clinical narrative: patient received the flublok vaccine by accident, he only wanted a covid vaccine and his partner wanted the flu shot. He was informed multiple times that he was getting the flu shot but did object until after it was already given. There was a miscommunication.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breast mass, Lymphadenopathy, Mammogram, Ultrasound breast
Clinical narrative: Enlarged Lymph Node. From Radiologist report on  annual mammogram: In the left breast, there is a prominent axillary lymph node. There is also an asymmetry seen in the CC view only at posterior depth in the lateral breast. 2. Left axilla: Prominent left axilla lymph node. Recommend targeted ultrasound for further evaluation. BI-RADS Category 0: Incomplete-additional imaging needed.  3. Left breast: Indeterminate asymmetry CC view only posterior depth lateral breast. Recommend additional views and possible ultrasound for further evaluation. BI-RADS Category 0: Incomplete-additional imaging needed.   9. cont'd: Vitamin C, Glucosamine/Chondroitin, fiber capsules.  18 cont'd  BI-RADS 0 -- incomplete assessment    From report on August 11 follow-up imaging:  Additional imaging of the left breast was obtained. The asymmetry in the posterior lateral aspect of the left breast is thought to represent a stable 6 mm mass in the deep 3:00 position of the left breast. This appears to contain fat suggesting that it represents a intramammary lymph node. This is not significant change from the 2017 exam.  Ultrasound was then performed targeting the left axilla. A prominent 4.2 cm fatty replaced lymph node is seen. The finding noted on the screening study is thought to correspond to a 1.6 cm lymph node in the lower axilla. The cortical thickness measures 0.47 cm.   From 11/11/2021 follow-up ultrasound LEFT ULTRASOUND: Targeted ultrasound was performed in the axilla and areas of previous interest. Lymph nodes have decreased in size. The most thickened lymph node has a cortical thickness of 2 to 3 mm, within normal limits, decreased when compared to previous exam when measured approximately 5 mm. There are no suspicious findings.  IMPRESSION AND RECOMMENDATION:  No sonographic signs of malignancy.  Recommend patient resume screening mammography due July 2022, as long as physical exam is unchanged.  BI-RADS Category 2: Benign
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: 70 doses of Pfizer-BioTech Covid Vaccine for pediatric patients (orange cap) Lot FK5618 were delivered assigned a beyond use date (BUD, do not use after date) by the manufacturer due to previous storage and handling issues at another facility.  The doses were mistakenly administered to 70 patients on 11/26/21
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: ADMINISTRATION OF IMPROPERLY STORED VACCINES
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Chest pain, Echocardiogram, Electrocardiogram, Fibrin D dimer
Clinical narrative: chest pain, possible myocarditis
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Metabolic function test, Myocardial necrosis marker
Clinical narrative: chest pain, possible myocarditis
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient had been 12 for 9 days but was given the dose for pediatric patients ages 5-11 years.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: ADMINISTRATION OF IMPROPERLY STORED VACCINES
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: Pain with pressure in left upper abdominal area that has remained for nearly 8 months.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Seizure, Skin laceration, Syncope
Clinical narrative: Patient had received his booster Moderna shot.  After about ten minutes, he tried to get up from his chair.  He slumped and fainted, and he seized for about five seconds before coming to.  He did cut his nose (we're not entirely sure how).  I had him lie on the floor with his feet elevated because he stated he felt lightheaded.  Paramedics were called, and they took over.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Patient was given a second dose of Moderna, but his initial series was Pfizer.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: ADMINISTRATION OF IMPROPERLY STORED VACCINES
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Incorrect route of product administration, Mobility decreased, Muscular weakness, Neuralgia
Clinical narrative: Believe injection was made into bursus which resulted in SIRVA (shoulder injury related to vaccine administration).  Have been participating in physical therapy.  Range of motion gained = 60% (overhead) and 20% (behind back); shoulder pain, severe loss of range of motion, weakness in arm, some nerve pain.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: Believe injection was made into bursus which resulted in SIRVA (shoulder injury related to vaccine administration).  Have been participating in physical therapy.  Range of motion gained = 60% (overhead) and 20% (behind back); shoulder pain, severe loss of range of motion, weakness in arm, some nerve pain.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Headache, Hyperhidrosis
Clinical narrative: 5mins post vaccination, pt reported flushing/sweating and headache.  No S/S distress.  VSS.  Once taken to medical area and given water, symptoms subsided.  No further complaints.  Partents instructed to call 911 if pt has any respiratory distress.  Pt released in stable condition.  Strong steady gait Vitals: 17:41 118/76, 103, 100% -- > 17:46 111/76
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient did not bring his immunization card to get his booster and we were unable to pull the information of his first two vaccines at time.  Patient stated he got his last dose more than 6 months before but when he brought his card to get vaccine information added, it showed it had not been 6 months since 2 nd dose.  Patient got first two doses of Pfizer Covid vaccine on 6-14-21 and 7-7-21 and got Moderna booster on 11-30-21.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: 70 doses of Pfizer-BioNTech COVID-19 vaccine for pediatric patients (orange cap) batch/lot# FK5618  assigned a beyond-use-date (BUD, do not use after date) by the manufacturer due to previous storage and handling issues at another facility.  The doses mistakenly administered to 70 patients on 11/26/2021.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Patient received only the powder vial of Menveo - diluted with sterile water diluent intended for MERCK MMR/Varicella vaccines. Root Cause:  Manufacturer packaging - the two part vaccine is not banded or in some other way attached together. Unless manually opened and banded together upon receiving the vaccine shipment - and with similar packaging to other single vial vaccines - it is easy for this error to occur. Recommended: either band/attach the two parts and package in different/much clearer way to identify OR Best suggestion is use single vial similar to Solumedrol where a plunger is pushed to move a stopper and combine the liquid with powder parts in the same vial - no drawing up/mixing and transferring into 2nd vial - decrease risk of administration errors and needlesticks.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: administration of improperly stored vaccines
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administration of improperly stored vaccines.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: 14 year old patient given a 5-11 dose of Pfizer COVID-19 vaccine.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia, Sleep disorder
Clinical narrative: At first there was an strong onset of fatigue. Within an hour I had fever, headache, and the chills. Slept through the night waking every 2-3 hours.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity, Pruritus
Clinical narrative: 11/23/2021 at about 10 pm you developed a headache and a sore right arm.  Then 11/24/2021 midmorning at about 10 am she noticed hives developing on her arms, they were very itchy.  The hives spread over her whole body  by about 7 pm.  Her entire body was itchy.  She also developed body aches and chills at about 10 am.  She stated she took a extra strength tylenol and rested.  11/25/2021 she reports that the chills and body aches resolved, but the headache and hives continued.  The hives gradually faded day by day.  Today she still has faint hives on her chest and arms.  Her headache resolved on 11/27/2021.  She placed ice on the hives as needed to control the itching.  She did not seek medical attention.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: 11/23/2021 at about 10 pm you developed a headache and a sore right arm.  Then 11/24/2021 midmorning at about 10 am she noticed hives developing on her arms, they were very itchy.  The hives spread over her whole body  by about 7 pm.  Her entire body was itchy.  She also developed body aches and chills at about 10 am.  She stated she took a extra strength tylenol and rested.  11/25/2021 she reports that the chills and body aches resolved, but the headache and hives continued.  The hives gradually faded day by day.  Today she still has faint hives on her chest and arms.  Her headache resolved on 11/27/2021.  She placed ice on the hives as needed to control the itching.  She did not seek medical attention.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Nausea
Clinical narrative: PT BECAME NAUSEATED AND DIZZY SHORTLY AFTER SHE RECIEVED HER J&J VACCINATION
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: 70 doses of Pfizer-BioTech Covid Vaccine for pediatric patients (orange cap) Lot FK5618 were delivered assigned a beyond use date (BUD, do not use after date) by the manufacturer due to previous storage and handling issues at another facility.  The doses were mistakenly administered to 70 patients on 11/26/21
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administration of improperly stored vaccines
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Pain in extremity, X-ray, X-ray of pelvis and hip
Clinical narrative: Severe pain right thigh, unable to walk.  10/10
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: ADMINISTRATION OF IMPROPERLY STORED VACCINES
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Pt came for Pfizer booster .The first dose was 6/29/21 2nd the dose was given 7/20/21 and booster given less than 6 months
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: administration of improperly stored vaccines
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness, Pain, Pain in extremity, X-ray
Clinical narrative: Initial shot pain followed with arm pain and shoulder pain. Stiffness in movement. Started with jab in May.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: 70 doses of Pfizer-BioTech Covid Vaccine for pediatric patients (orange cap) Lot FK5618 were delivered assigned a beyond use date (BUD, do not use after date) by the manufacturer due to previous storage and handling issues at another facility.  The doses were mistakenly administered to 70 patients on 11/26/21
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: patient had seizure, was taken by ambulance to the hospital.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Rash
Clinical narrative: After receiving Janssen Vaccine patient's BP dropped to 70/42. Patient was laid down in a supine position. BP increased to 98/62 and patient was sat back up. BP continued to remain stable at 110/60. Nurse then noticed a fine rash on limbs and trunk. Benadryl was administered and BP dropped again to 72/56. patient was laid back down in a supine position and BP increased to 118/72. Patient was transported to the hospital via EMS and was given prednisone and discharged home.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Pallor, Vomiting
Clinical narrative: Patient was instructed to sit in waiting area of pharmacy after administration of vaccine.  He started feeling dizzy within a few minutes after administration.  Patient was being monitored and motioned for assistance.  He looked pale and was sweating and stated he felt like fainting and vomitting.  EMS was called and patient's vitals were taken and appeared within normal range.  He was taken by paramedics for observation in the ambulance.  I am not sure if patient was taken to hospital or if he went home with a family member.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Diplopia, Headache, Magnetic resonance imaging normal
Clinical narrative: I received the Moderna COVID-19 booster on 11/24/21 (my first two shots were also Moderna). Two days later, on 11/26/21, I started have double vision periodically and a mild headache.  The double vision and headache continued on 11/27/21. Upon waking up on 11/28/21, the double vision was continuous and headache continued. Went to ER on 11/28/21. MRI showed no problems. On 11/29/21, went to optometrist, Dr. He said it was probably nerve related and is referring me to a specialist. As of today, 12/1/21, double vision continues and headache is gone. I'm awaiting appointment with neurologist.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administration of improperly stored vaccines
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Oropharyngeal pain
Clinical narrative: Accompanied by mom. Patient crying and needed comfort throughout getting covid vaccine. Vaccine administered and still crying throughout 15 minute waiting period. Patient started complaining about throat pain and vital signs taken. Vital signs: 126/65 HR: 71 Resp: 22 and 02: 96. 02 stayed above 96. Patient crying throughout and breathing heavily. Medical alert response called and RN and MD  came to assess patient. MD stayed and assessed patient. MD advised to have patient wait outside away from vaccination area and will come back to assess again. Patient waited outside with RN and MD assessed and cleared patient to go home.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Feeling cold, Pharyngeal swelling, Throat irritation
Clinical narrative: Patient reported throat swelling (similar to her reactions with Shellfish and Hydroxyzine,  2 Benadryl 25mg were given. Vitals taken and were normal (Nurse reported possible arrhythmia and patient states she is already being seen by a cardiologist). After 30 minutes the patient reported some improvement in the throat area  but still a burning sensation. Patient said she felt a cool rush in her body.  The patient also reported anxiety (that she had prior to vaccination).  She refused EpiPen and was going to go to Urgent Care for further evaluation (A party that came with the patient is bringing her)
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: The mom said that the patient's leg swelled. The mom said that she was in touch with the pediatrician. They both thought it was unrelated but monitored the child. She said that the pediatrician suggested to get the second dose in the opposite arm. Just documenting this because the mom said she wanted us to know. She said the pediatrician and her wanted the second dose.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Wrong product administered
Clinical narrative: 9 year old patient was given .025 Moderna booster dose (meant for his father) in error. Patient should have received 0.2 of pediatric Pfizer 5-<12.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: ADMINISTRATION OF IMPROPERLY STORED VACCINES
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Scan abnormal, Thrombosis
Clinical narrative: pain in lower right leg and knee / scan for blood clots / 14 days of Lovonox injections (2 per day)/ I see a hematologist on December 7
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: administration of improperly stored vaccines
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pyrexia, Seizure, Tremor
Clinical narrative: Fever, sweating, chills followed by seizure.  Seizure and uncontrollable shaking passed and returned several times overnight.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 70 doses of Pfizer-BioTech Covid Vaccine for pediatric patients (orange cap) Lot FK5618 were delivered assigned a beyond use date (BUD, do not use after date) by the manufacturer due to previous storage and handling issues at another facility.  The doses were mistakenly administered to 70 patients on 11/26/21
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Malaise, Pruritus, Rash macular, Urticaria
Clinical narrative: On the day of vaccine he was up several times saying he was not well with a cough and the next am until 10am he felt better. Friday night he was sleeping and in the middle of the night it was itchy and the next am he had hives, big areas in his chest. Back, legs and neck big red blotches, Called nurse line on sat am and they said to give Benadryl and it cleared on 30Nov2021.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Cough, Headache, Pyrexia, Respiratory tract congestion
Clinical narrative: feverish, cough, congestion, lower energy level, mild headaches, starting 11/28/21
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pallor, Presyncope, Visual impairment
Clinical narrative: 4mins post vaccination pt reported dizziness.  Pt was was pale, mild sweating and blackened vision.  Pt appears to have had a moderate vasovagal event.  Vitals: 106/59, 58, 16, 99% on RA Pt stable and released from the vaccination site at 17:09.  NAD and feeling 100% better
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: administration of improperly stored vaccines
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Influenza like illness, Pruritus, Urticaria
Clinical narrative: I had some flu like symptoms the night of the third dose of the vaccine. The following night I had some itching. I put some Benadryl on the area I was prescribed a strong antihistamine. I had little lines of hives on the front of my body. The back of my body even on my legs had huge hand size patches of hives. The medication helped. On the night of the third day I broke out in hives again and then I was prescribed Steroids. The hives have improved now and it has been a week.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: ADMINISTRATION OF IMPROPERLY STORED VACCINES
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: There is a possibility that these COVID doses were given beyond their recommended time of use greater than 12 hours post-puncture.  The dates involved were 9/1/2021, 9/9/2021 and 10/22/2021.  The number of patients impacted is 9.  DOH and CDC have been notified and meetings conducted.  We are following their recommendations to notify and re-vaccinate all patients.  We will enter separate VAERS reports for any individuals experiencing adverse reactions. Root cause identified and processes modified to prevent re-occurrence.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error, Product storage error
Clinical narrative: 70 doses of Pfizer-BioTech Covid Vaccine for pediatric patients (orange cap) Lot FK5618 were delivered assigned a beyond use date (BUD, do not use after date) by the manufacturer due to previous storage and handling issues at another facility.  The doses were mistakenly administered to 70 patients on 11/26/21
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered
Clinical narrative: Pt was here on 11/22/2021 for Well Child and was given ActHib in addition to other imms due.  Mom and pt came back on 11/29/2021 for remainder of imms to be given.  Normal Clinical staff for provider was busy so I checked to see what was due.  Documentation showed ActHib, Hep A and flu was due.  When asked, mom declined flu.  I pulled up ActHib and HepA.  Normal clinical staff took over as they were not busy any more.  I showed her the Documentation and what was due, we verified what was pulled up and ready to administer and she gave the injections.  While recording the administration in system, she was alerted the ActHib was not due and was an invalid dose.   Upon further investigation, we noticed ActHib was recorded in system as being given but documentation did not reflect that.  Contacted Health Dept and explained to her the issue.  She said there should be no problem other than maybe being more painful at the injection site.  This was reported back to appropriate provider and then mom was notified by RMA.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: administration of improperly stored vaccines
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 70 doses of Pfizer-BioTech Covid Vaccine for pediatric patients (orange cap) Lot FK5618 were delivered assigned a beyond use date (BUD, do not use after date) by the manufacturer due to previous storage and handling issues at another facility.  The doses were mistakenly administered to 70 patients on 11/26/21
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient came in for second COVID-19 Pfizer vaccine. Patient given the vaccine one week early.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Seizure, Vaccine positive rechallenge
Clinical narrative: Severe chills, soreness then later seizure
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: For about 45 days I was losing handfuls of hair every single day, it finally stopped when I started taking hair skin nail vitamins. But after having many conversations with people I noticed a trend that we were all losing hair at an extreme rate for no reason. I feel like there could be a relation to the covid vaccine.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against and then tested positive for COVID19
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administration of improperly stored vaccine
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received booster early on 12/01/2021 second dose was given 0826/2021
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: ADMINISTRATION OF IMPROPERLY STORED VACCINES
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 70 doses of Pfizer-BioTech Covid Vaccine for pediatric patients (orange cap) Lot FK5618 were delivered assigned a beyond use date (BUD, do not use after date) by the manufacturer due to previous storage and handling issues at another facility.  The doses were mistakenly administered to 70 patients on 11/26/21
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Cough, Ear discomfort, Eye pruritus, Eye swelling
Clinical narrative: 1:23cough,scratchy mucous in trachea got candy disc but didnt help 1:25 nurse got got cold water helped 1:50 left 1:53 itchy eyes, nasal drainage-- used inhaler pressure ears and neck can feel some swelling 2:56 called dr office not in clinic 3:05 50 mg benadryl taken 3:23 left message dr  cont to have swelling 4:08 talked dr wait to start steroid 4:40 throat scratchy loosing voice,eyes swelling slightly 6:45benadryl working no further swelling
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Swelling, Throat irritation
Clinical narrative: 1:23cough,scratchy mucous in trachea got candy disc but didnt help 1:25 nurse got got cold water helped 1:50 left 1:53 itchy eyes, nasal drainage-- used inhaler pressure ears and neck can feel some swelling 2:56 called dr office not in clinic 3:05 50 mg benadryl taken 3:23 left message dr  cont to have swelling 4:08 talked dr wait to start steroid 4:40 throat scratchy loosing voice,eyes swelling slightly 6:45benadryl working no further swelling
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: ADMINISTRATION OF IMPROPERLY STORED VACCINES
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Lethargy
Clinical narrative: Approximately 5 minutes after receiving the booster dose of Moderna the client became lethargic and experienced chest pains. O2 SATs were at 75-80. 2 liters of O2 was started. O2 SATs went up to 98 and then dropped again. 4 liters of O2 was then started and 911 was called. Client was transported to the emergency room.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: administration of improperly stored vaccines
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Medication error
Clinical narrative: Medication error, Spoke with healthcare professional- Advised NOT to repeat 5-11 dose to complete series. To give adolescent dose Pfizer for 12 y.o. for 2nd dose to complete series on return date of 12/10/21. Parent notified, aprop process completed per policy by  reporting RN.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: 70 doses of Pfizer-BioTech Covid Vaccine for pediatric patients (orange cap) Lot FK5618 were delivered assigned a beyond use date (BUD, do not use after date) by the manufacturer due to previous storage and handling issues at another facility.  The doses were mistakenly administered to 70 patients on 11/26/21
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administration of improperly stored vaccines
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: ADMINISTRATION OF IMPROPERLY STORED VACCINES
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 70 doses of Pfizer-BioTech Covid Vaccine for pediatric patients (orange cap) Lot FK5618 were delivered assigned a beyond use date (BUD, do not use after date) by the manufacturer due to previous storage and handling issues at another facility.  The doses were mistakenly administered to 70 patients on 11/26/21
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Vaccination site joint pain
Clinical narrative: I didn't get very sick with the first two injections. I was in bed for 36 hours after the third. My arm hurt like it would hurt after an injection- but that never went away. I started getting deep joint pain where I got the vaccine. I went back to see a doctor who I had seen for a shoulder injury previously with that shoulder. She didn't seem to think that my presentation was similar to what she had seen me for before. It was a deep aching shoulder pain. I couldn?t lay on that side. It didn't hurt to move my arm, but it was a deep aching pain deep within the shoulder joint. She scheduled me to go in for a steroid injection when I went to visit her on 11/18/2021, and she scheduled me for the following Tuesday. I never was able to get the steroid injection. The shoulder has progressively improved without the injection. Partially recovered.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Nausea
Clinical narrative: Nausea immediately after injection, lasting 2 hours.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated and later tested positive for COVID-19.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: administration of improperly stored vaccines.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 70 doses of Pfizer-BioTech Covid Vaccine for pediatric patients (orange cap) Lot FK5618 were delivered assigned a beyond use date (BUD, do not use after date) by the manufacturer due to previous storage and handling issues at another facility.  The doses were mistakenly administered to 70 patients on 11/26/21
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Syncope
Clinical narrative: Pt had a syncopal event immediately post vaccination.  Pt was taken to med bay.   Vitals: 12:44 100/60, 85, 100% -- > 12:46 98/62, 88 -- > 12:48 103/70 VSS  Pt flushed but color improved when placed in lying position with legs elevated.  Pt stable upon release.  No S/S of distress.  No swelling of the lips or tongue.  Gait strong and steady.  mother instructed to call 911 if pt has s/s respiratory distress.
Age: 10.0
Sex: M
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administration of improperly stored vaccines
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: ADMINISTRATION OF IMPROPERLY STORED VACCINES