chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse symptoms reported; improperly stored vaccines were administered to patients; This spontaneous report was received from a nurse referring to a 3 years-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not provided.   It was reported that on 03-DEC-2019, varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R018138) was under temperature excursion at 6 degrees Fahrenheit (F) to 14 degrees F (-14 degrees centigrade (C) to -10 degrees C) (8.7 F), for a time frame of 50 minutes, and the previous temperature excursion was at 6 degrees Fahrenheit (F) to 14 degrees F (-14 degrees centigrade (C) to -10 degrees C) (6.9 F) for a timeframe of 50 minutes. On 06-DEC-2019 , the patient was vaccinated with improperly stored (product storage error) varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R018138 has been verified to be a valid number; expiration date 25-JUN-2020) for prophylaxis (strength, dose, frequency, route of administration, anatomical location were not reported). It was reported that the call was due to data logger. No adverse symptoms were reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1912USA001555:same reporter US-009507513-2006USA003314:same reporter US-009507513-2006USA005617: US-009507513-2006USA005616:same reporter US-009507513-2006USA005618: US-009507513-2006USA003313:
She died.  Gradual loss of memory, cognitive abilities and balance from a week or two after the last injection, culminating in hospitalization on Dec 05, 2021 with low blood pressures and B1 deficiencies, excessive sleep, inability to stand or walk, confusion, disorientation and difficulty eating/swallowing without aspiration.
Patient was given Moderna and is under the age of 18. Patient is not experiencing any problems  and mom is monitoring patient.
Pt developed local inflammation of left deltoid for three weeks, unimproved. Pt has pain in left shoulder and perceived weakness of left shoulder.
Vertigo. Lasted for two days. Not able to keep food down. Vomited even with no food after the dizzy spell.  Lying down and sleeping helped.
a brown circle that looked like a blood clot inside; warm to touch and spreading all over her body; soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm), SKIN DISCOLOURATION (a brown circle that looked like a blood clot inside) and SKIN WARM (warm to touch and spreading all over her body) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 002B21A) for COVID-19 vaccination.     No medical information provided.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (soreness in arm). On 10-Apr-2021, the patient experienced SKIN DISCOLOURATION (a brown circle that looked like a blood clot inside) and SKIN WARM (warm to touch and spreading all over her body). On 08-Apr-2021, PAIN IN EXTREMITY (soreness in arm) had resolved. At the time of the report, SKIN DISCOLOURATION (a brown circle that looked like a blood clot inside) and SKIN WARM (warm to touch and spreading all over her body) outcome was unknown. Not Provided          No concomitant medication provided. No treatment medication provided.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-202126, MOD-2021-202126 (Patient Link).
Pt. was given dose intended for 5-11 year olds not dose intended for 12 and over.  No adverse sequelae
About an hour after receiving the vaccine I started having difficulty breathing and it went into an asthma attack. I used my rescue inhaler which I keep on hand due to allergies. I used it 3 times that afternoon and evening. I felt nauseated but did not vomit. I had watery diarrhea twice. Nausea continued for 24 hours with loss of appetite. That has now abated. The injection site did not hurt until the next day when it started with tenderness then quickly turned red and painful and hot to the touch. Wednesday and Thursday the arm started getting a rash and it has spread up to the neck and face.  Headache started the night of the injection and became intense (near migraine level) and stayed painful for 24+ hours. Fatigue began the night of the injection and has gradually gotten better over Wednesday and Thursday. Treated with Tylenol, rescue inhaler, Benadryl and hydrocortisone creams, rest, drinking lots of water, and notified my family doctor. Although I still have a rash and the injection site is hot and sore, I am considering myself recovered from the side effects.
"racoon eyes" black eyes, eye swelling per patient. Similar adverse event occured after 1st two series
Non - immunocompromised patient received Moderna 0.5mL as B1 on 09/27/21 at health department location as indicated in this report.
Nausea and vomiting 24 hours post administration 24 hours after vomit, diarrhea   Ongoing nausea, vomiting and diarrhea on and off every few days for 2 weeks
Information has been received from an allergist concerning a 12 month old female with a hx of chronic eczema and recurrent otitis media who on 05MAR2004 was vaccinated with a dose of measles virus vaccine live +mumps virus vaccine live+ rubella virus vaccine. On 05MAR2004, the pt was concomitantly vaccinated with a dose of varicella virus vaccine live. On 05MAR2004, it was noted that the pt had a rash and therapy with sulfamethoxazole/trimethoprim was discontinued. On 08MAR2004, the pt developed a fever and rash. On 11MAR2004, the pt developed a viral exanthema described by the parents of the pt as a diffuse measles like rash from the head to the toes. The patient also had conjunctivitis and rhinitis. The pt was seen by the reporting physician and was treated with  Eldel, Triamnic, Motrin, oatmeal bath, and Zyrtec. No additional info is expected.
ALS; Profound fatigue; weakness; joint pain; Difficulty getting up from a crouch position; This is a spontaneous report from a contactable nurse reported for herself.  A 61-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 02Apr2021 11:15 AM(Batch/Lot Number: EP7533) as 1ST DOSE, SINGLE for covid-19 immunization, at the age at vaccination of 61 years old.  Medical history included  Damage from spinal cord tumor at C2, s/p resection, s/p ablations for cardiac arrhythmia, amyotrophic lateral sclerosis, Allergies. The patient's concomitant medications were not reported.  The patient experienced ALS, profound fatigue, weakness, joint pain and difficulty getting up from a crouch position, all on 03Apr2021 with outcome of recovering.  Reported Event: Profound fatigue, weakness and joint pain.  Difficulty getting up from a crouch position to the point that she googled 'how to get up off the floor'. She was worried she had Amyotrophic lateral sclerosis (ALS.)  This progressed to having difficulty getting both up and down, even from a chair. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. The event ALS was serious as medically significant. No treatment received for events.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the available information, the Company considers the reported event ALS is unrelated to bnt162b2 vaccination, but more likely due to underlying or inter-current medical conditions. The patient has medical history of amyotrophic lateral sclerosis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
horrible reactions/If they had been frail it would have killed them; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On an unknown date, the patient received Shingles vaccine, Influenza vaccine Quadrivalent unspecified season and PNEUMONIA VACCINE. On an unknown date, unknown after receiving Shingles vaccine and Influenza vaccine Quadrivalent unspecified season, the patient experienced near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown.   It was unknown if the reporter considered the near death experience to be related to Shingles vaccine and Influenza vaccine Quadrivalent unspecified season.   Additional details were as follows: The age at vaccination was not applicable. The age group was not reported but was captured as adult as per vaccine indication.  The patient received shingles vaccine, flu vaccine and pneumonia vaccine  and experienced horrible reactions. It was unknown if the reporter considered the near death experience to be related to Pneumonia vaccine. This case has been linked to US2020AMR189618, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR189618:same reporter
Thought I was having a heart attack. Brought to hospital ER. Diagnosed with Pericarditis
Patient came into pharmacy to state that her arm is still hurting after receiving the Prenar vaccine after almost 2 months.
10-12cm x 20cm sharply-demarcated area of erythema at injection site on left upper arm. Patient reports warmth, swelling and redness immediately after injection. She reported it one week later because it getting bigger and continues to itch.
Developed a papular rash the evening of the vaccine. Started on opposite arm vaccine was given. Visited HCP 12 days later and has now spread across chest, back and down arms. Chief complaint of extreme itching.
In the middle of the night of August 26th,  following her afternoon vaccine shot on August 25th, pt. developed incredible pain in her elbow, knee, and finger joints.  She experienced fatigue and bouts of diarrhea from August 26th through August 30th.  She developed a severe headache and swollen neck/jaw glands (Friday, August 27th) along with non-stop sneezing (Saturday, August 28th) that lasted until Monday, August 30th.  She still has swollen glands and fatigue, however, the headache, diarrhea, and sneezing are diminishing.  On Tuesday, August 31st, she is now starting to develop psoriasis on her scalp (which has been at bay for over a year).
9/11/21 Injection at 11AM 9/12/21 3A.M. severe vomiting, diarrhea, unable to move ARM mental confusion - extreme weakness could not stand due to weak/dizzy - extreme fatigue  9/13/21 diarrhea - fatigue - weakness - dizzy persist - mental confusion 9/14/21 Fatigue - weakness - dizzy persist 9/15/21 Weakness + Fatigue persist 9/16/21 symptoms resolved
couldn't move right arm/ couldn't use right arm/ unable to use her right arm for two days; ongoing severe pain/ excruciating pain/ like someone was "stabbing" her in her right arm; flu-like symptoms; severe pain right arm/ severe pain right forearm/ throbbing right arm/ throbbing right forearm; "horrible sensation"; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe pain right arm/ severe pain right forearm/ throbbing right arm/ throbbing right forearm), SENSORY DISTURBANCE ("horrible sensation"), MOBILITY DECREASED (couldn't move right arm/ couldn't use right arm/ unable to use her right arm for two days), PAIN (ongoing severe pain/ excruciating pain/ like someone was "stabbing" her in her right arm) and INFLUENZA LIKE ILLNESS (flu-like symptoms) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included Pain. Concurrent medical conditions included Hypertension (Hypertension) since 2003, Rheumatoid arthritis (Rheumatoid arthritis) since 2003 and Hypothyroidism since 2003. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), HYDROXYCHLOROQUINE, TRAMADOL, CARVEDILOL and LOSARTAN for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (severe pain right arm/ severe pain right forearm/ throbbing right arm/ throbbing right forearm), SENSORY DISTURBANCE ("horrible sensation"), PAIN (ongoing severe pain/ excruciating pain/ like someone was "stabbing" her in her right arm) and INFLUENZA LIKE ILLNESS (flu-like symptoms). On an unknown date, the patient experienced MOBILITY DECREASED (couldn't move right arm/ couldn't use right arm/ unable to use her right arm for two days). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and PREDNISONE ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. On 22-Feb-2021, PAIN IN EXTREMITY (severe pain right arm/ severe pain right forearm/ throbbing right arm/ throbbing right forearm), SENSORY DISTURBANCE ("horrible sensation"), MOBILITY DECREASED (couldn't move right arm/ couldn't use right arm/ unable to use her right arm for two days), PAIN (ongoing severe pain/ excruciating pain/ like someone was "stabbing" her in her right arm) and INFLUENZA LIKE ILLNESS (flu-like symptoms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
BLURRY RIGHT EYE; DISTRESSED MOOD; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 31-JUL-2021, the subject experienced blurry right eye. On 31-JUL-2021, the subject experienced distressed mood. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blurry right eye, and the outcome of distressed mood was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
Pt started feeling faint immediately after receiving the vaccine. Pt was monitored. Pts vitals are stable. Pt recovered. Pt didn?t require transport to hospital.
Patient tested positive for COVID-19 on 09/07/2021. Asymptomatic
Gait weakness, unable to walk, drooling starting on 5/1/23, IVIG started d/t possible AIDP per Brighton Criteria with mild improvement of symptoms.
Left arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm soreness) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     The medical history was not provided by the reporter.  Concomitant products included WARFARIN, DILTIAZEM, LISINOPRIL and VITAMIN D NOS for an unknown indication.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced PAIN IN EXTREMITY (Left arm soreness). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Left arm soreness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient explained that she thought the person who gave the shot put it too high on her arm.   This case was linked to MOD-2021-253973 (Patient Link).
Narrative: COVID infection following COVID vaccine series 01/11 COVID vaccine dose#1 02/01 COVID vaccine dose #2 09/28 COVID vaccine dose #3 12/19 pt seen in ED c/oi wheezing, productive cough x 2 days, low grade fever; COVID Positive, requests regeneron 12/20 c/o mild headache, cough, given Regeneron in community center 12/21 c/o cough, rhinorrhea, sore throat
PATIENT BECAME DIZZY SEVERAL MINUTES AFTER ADMINISTRATION. BECAME LIMP, PALE, LIPS TURNED PURPLE, VERY SHALLOW/NO BREATHING. EYES WIDE OPEN BUT NONRESPONSIVE. CALLED 911. GAVE HER A DOSE OF GENERIC EPI-PEN AND PATIENT WOKE UP AND BECAME REPSONSIVE RIGHT AWAY. VOMITTED A FEW MINUTES LATER BUT OVERALL SAID SHE WAS FEELING FINE. PARAMEDICS CAME AND ASSESSED PATIENT AND DEEMED HER OK.
Vaccination was unusually painful upon administration. Within an hour, I was feeling really faint, nauseated, chest and neck red, and remarkable swelling of right upper arm. Bruise at injection site. Initial treatment: I lied down and put on ice on arm. Could not take pain reliever due to nausea. The next morning, I went to Employee Occupational Health and reported reactions.
experienced constipation since; This is a spontaneous report from a contactable consumer (Patient) reporting himself. A 24-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 25Jul2021 as dose 1, single (at the age of 24-years-old) for covid-19 immunisation. Patients Weight (kg): 69.4 and Height (cm): 160 were reported. The patient medical history and concomitant medications were not reported. Other products, patient history and investigation assessment were not provided. On an unspecified date the patient experienced constipation. It was reported that, since getting the vaccine patient has been unable to go to the bathroom that well. The outcome of the event was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained. No further information is expected.
Patient died two days after receiving vaccines. Infant had multiple problems including failure to thrive, and developmental delays. Was admitted with complete heart block.  8/28/07 Spoke w/the reporter on this case who will provide medical records from clinic & hospital as well as a copy of the Death Certificate.  No autopsy was done.  Reporter stated this child had multiple medical problems & was being followed by several clinic specialists including geneticist.  Sibling of this child also had multiple problems & expired at unknown time.  9/7/07 Reviewed medical records & Death Certifiate from reporter.  COD stated as complete heart block w/microcephaly & failure to thrive as contributing factors.  Vax record confirms dose & Lot # of all vax as reported.   Had microcephaly, hypertonia & contractures of UEs noted on d/c from birth hospital.  Referred by birth hospital to Easter Seals for developmental therapy eval 7/07.  Medical records show that on day of vax had cough & sneeze along w/very slow feeding & poor growth noted.  Referred for feeding eval.  PCP records indicate patient on home monitor.  Neuro, Genetic & Cardio consults.  Very slowly gained weight & remained significantly underweight.  Genetics eval done 7/07.  Developmental delay.  Cardiac consult on day of death reveals patient admitted 8/24 for diarrhea & poor feeding then developed slow heart rate & complete heart block.   FINAL DX: complete heart block, microcephaly & failure to thrive.
fever and chest tightness. Onset yesterday. Began after he received the second dose of his pfizer covid vaccine. He has generalized malaise and myalgias. Chest tightness with sob.  Ed medications- Ns bolus 1000 ml, toradol 15 mg IV
rash on injection arm around injection site with redness,swelling,and itching.Was given prescriptions for prednisone and cetirizine and after 3 days little or no change.
Symptoms started 11/19 - painful rash to right forearm, c/o itching rash is blistering. Patient seen 11/20/11, diagnosed with shingles, seen by MD. 11/20/2011 - weight 36 lbs, temperature 99.7 degrees F (temporal).
Experience a swollen bulge next to clavicle bone. Patient noticed the swollen area 4 days after vaccination
Patient's spouse tested positive for COVID-19 on 01/22/2021 and had COVID-19 symptoms beginning 01/18/20201. At the time of patient's vaccine (01/19/2021), the patient was unaware of his spouse's COVID-19 status, as they had little contact with others and thought it was a cold. Patient began having COVID-like symptoms on 01/23/2021: cough, fatigue, loss of taste and smell, muscle/body aches, headache, sore throat, congestion and runny nose, nausea, vomiting and diarrhea. Patient has had two subsequent negative COVID-19 tests while symptomatic. Because of his symptoms, his spouse's symptoms and positive COVID status, practitioners have cautioned patient to act as if he has COVID. He is under quarantine orders per Public Health. The concern from the patient, Doctors and Public Health officials has been the patient's negative status while obviously symptomatic, and if he can pass COVID if he is symptomatic but testing negative. He has another test scheduled for Saturday 1/30/2021.
sick; muscle weakness; tremors; Initial information received on 17-Nov-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 71 years old male patient who had  muscle weakness, tremors and sick while receiving vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (form, strength, dose, frequency, site, route: unknown, with an unknown batch number and expiry date: unknown) for Immunization.  On an unknown date the patient had  muscle weakness (muscular weakness), sick (illness) and tremors (tremor) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE..  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events   At time of reporting, the outcome was Unknown for the events; Sender's Comments:  US-SA-2022SA478968: