chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Following the administration of the vaccine within 5 minutes pt complained of not feeling well, felt dizzy and fainted. Pt came to and oriented name, place and time. VS assessed and HR 40's, color pale. Pt rested by 30 minutes and reported feeling better. VS rechecked BP 90/54/ HR-64/R-20/O2 sat- 100%. Denied SOB or difficulty breathing. No hives or swelling of face or throat noted or reported.
vaccinated with pfizer Jan-Feb 2021. Had cough, sore throat but its relieved . Now you have runny nose and congestion.
Information has been received from an unspecified reporter from the billing office of a physician's office referring to a 17 years old female patient. The patient had no pertinent medical history and drug reactions/allergies. On 11-JUL-2016, the patient was vaccinated with an unspecified dose in the series of GARDASIL (lot# K010215, expiration date 5-MAY-2017, route not reported). There was no concomitant therapy. On 12-JUL-2016, the patient woke up in the morning with an unspecified rash on an unspecified location on her body. The patient sought medical attention via calling the physician. No laboratory test was performed. The patient received unspecified treatment. As of the time of this report, the patient was "doing better". The causality between GARDASIL and event was not provided. Additional information has been requested.
Unable to walk/couldn't move legs; had to contrite hard just to walk, then I just got worse.; Harder to keep my balance; Weaker; Feeling extremely tired all the time; Kept falling; Hands would ache; I started to drop things and it was difficult; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient. A 30-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GAIT INABILITY (non-serious), outcome "not recovered", described as "Unable to walk/couldn't move legs"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "had to contrite hard just to walk, then I just got worse."; BALANCE DISORDER (non-serious), outcome "unknown", described as "Harder to keep my balance"; ASTHENIA (non-serious), outcome "unknown", described as "Weaker"; FATIGUE (non-serious), outcome "unknown", described as "Feeling extremely tired all the time"; FALL (non-serious), outcome "unknown", described as "Kept falling"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Hands would ache"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "I started to drop things and it was difficult".  Additional information Description of Event Outcome: It was started after getting your vaccine. Reporter is 30-year-old. Who has been unable to walk since Mar. Reporter started walking funny start in Nov last year. Reporter started walking width and it was starting for the reporter to be harder to keep the balance. Reporter started getting weaker and feeling extremely tired all the time. Reporter had to contrite hard just to walk, then reporter just got worse. Reporter kept falling and eventually reporter stop walking. Reporter could not move legs and my hands would ache. Reporter started to drop things and it was difficult.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Recurrent vaccine-associated myocarditis; Disease recurrence; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Recurrent vaccine-associated myocarditis) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE:  The patient's past medical history included Myocarditis (vaccine-associated myocarditis).    In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Recurrent vaccine-associated myocarditis) (seriousness criterion medically significant) and DISEASE RECURRENCE (Disease recurrence). At the time of the report, MYOCARDITIS (Recurrent vaccine-associated myocarditis) and DISEASE RECURRENCE (Disease recurrence) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (Recurrent vaccine-associated myocarditis) and DISEASE RECURRENCE (Disease recurrence) to be related.    Concomitant and treatment medications were not reported.  The study was conducted among 431 patients with a prior history of vaccine-associated myocarditis, pericarditis, or myopericarditis. Out of this 171 received COVID-19 vaccine in the year 2021 with median age- 39 years (range 21-67 years).  From the vaccine recipients, 11 patients experienced cardiac-suggestive symptoms (chest pain, palpitations, or dyspnea) within 30 days of COVID-19 vaccination. Four patients met the criteria for recurrent. All 4 COVID-19 recurrent cases fully recovered with minimal supportive care within weeks (myocarditis) to months (pericarditis).  This case describes the patient who developed recurrent myocarditis within 3 days of receiving Moderna vaccine.  Company Comment: This is a Literature non-study case concerning a 49-year-old male patient, with past medical history of vaccine-associated myocarditis, who experienced the expected and serious (due to medically significant) event of Myocarditis, which occurred within 3 days after mRNA-1273 vaccine, administered as second dose within COVID-19 vaccination schedule. As reported, patient fully recovered with minimal supportive care within weeks. No information disclosed about diagnostic tests performed or treatments received. Medical history of vaccine-associated myocarditis could be a confounding factor for the case. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.      This case was linked to US-MODERNATX, INC.-MOD-2023-726875 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726875:50 YO male
Had the vaccine 9-14 and on Dec 24 began with body aches. Had a fever for 3 weeks and severe fatigue for 6 weeks. Tested negative for covid x 3 and negative for flu x 2. Seen at urgent care then Primary care and referred to GI for elevated liver enzymes.
Pt's arm was red and a little swollen and pt complained that it was itching and that it hurt. Mother said that pt has received flu vaccine in the past with no adverse reaction. Vaccine was administered by certified immunizing technician and it seemed that vaccine was administered a little too low in the patient's arm. It was administered about in the center of the patient's arm. Pt had no trouble breathing.
SEVERE PAIN IN ARMS, LEGS, NECK, SHOULDER, FOREARMS,HANDS,FINGERS. LOW GRADE FEVER COMES AND GOES.  THIS HAS GONE ON CONTINUALLY SINCE THE SHOT AND HAS PERSISTED FOR MORE THAN 8 WEEKS. I HAVE SEEN A PHYSICIAN WHO DID BLOOD WORK ON ME AND DETERMINED THAT MY MUSCLE ENZYMES WERE DOUBLE WHAT THEY SHOULD BE AND SENT ME TO A RHEUMATOLOGIST.  I AM STILL WAINTING FOR THAT APPOINTMENT.  MEANWHILE, I HAVE RECIEVED TWO ROUNDS OF HIGH DOSE PREDINISONE WHICH HELPED SOMEWHAT WHILE I WAS ON THEM BUT STOPPED IMMEDIATELY UPON CESSATION OF THE DRUG.
NECK PAIN; BODY ACHES; EARS HURT; BACK PAIN; THROAT KIND OF STINGS; CHILLS; NO STRENGTH; HEAD ACHE; ACHE IN ARM; FEVER; 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 (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 18:00 for prophylactic vaccination. No concomitant medications were reported. On 20-MAY-2021, the subject experienced ache in arm. On 20-MAY-2021, the subject experienced fever. On 20-MAY-2021, the subject experienced head ache. Laboratory data included: Body temperature (NR: not provided) 103 F. On 22-MAY-2021, the subject experienced neck pain. On 22-MAY-2021, the subject experienced body aches. On 22-MAY-2021, the subject experienced ears hurt. On 22-MAY-2021, the subject experienced back pain. On 22-MAY-2021, the subject experienced throat kind of stings. On 22-MAY-2021, the subject experienced chills. On 22-MAY-2021, the subject experienced no strength. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from fever, ache in arm, head ache, neck pain, throat kind of stings, ears hurt, chills, body aches, no strength, and back pain. This report was non-serious.
Improperly stored PROQUAD were administered to 10 patients; No additional adverse symptoms reported; This spontaneous report was received from an office manager concerning a patient of unknown age and gender.   The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) lot # S013712 and expiration date 01-NOV-2020 (dose and route were not provided), reconstituted in sterile diluent (STERILE DILUENT), for prophylaxis. It was unknown if the sterile diluent (STERILE DILUENT) used to reconstitute the vaccine was stored at proper temperature. No additional adverse events symptoms were reported. The temperature excursions were reported as follows:  measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) (Lot # S013712, expiration date 01-NOV-2020)  Temperature  Total time in the range 6 degrees Fahrenheit (F) to 14 F (-14 degrees Celcius (C) to -l0 C) for 30 minutes Total time in the range 15 F to 46 F (-9 C to 8 C) for 7 hours;  Total time in the range 47 F to 77 F (9 C to 25 C) for 9 hours  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2001USA008160: US-009507513-2001USA008161: US-009507513-2001USA008163: US-009507513-2001USA008164: US-009507513-2001USA008165: US-009507513-2001USA008159: US-009507513-2001USA008158: US-009507513-2001USA008157: US-009507513-2001USA008162:
Shivering; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 2nd dose of Shingrix (unknown). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced shivering. On an unknown date, the outcome of the shivering was not recovered/not resolved.   It was unknown if the reporter considered the shivering to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix in early December and he complains that he has shivering intermittently.  The shivering as come and go, but when the shivering onsets, it comes on strong and feels as if he cannot get warm enough. The reporter was the daughter of the patient.  The reporter had limited vaccination information and was okay with follow up.
4/13/21: 26 y.o. male who presents with central nonradiating chest pain and dyspnea for the past 2 mornings.  Seen in urgent care and sent here for elevated troponin.  EKG nonischemic.  No symptoms currently.  Repeat troponin slightly elevated.  BNP elevated but no clinical evidence of heart failure.  CRP elevated, sed rate normal.  Respiratory viral panel negative.  CTA PE study negative for PE or other acute pathology.  Echo normal per cardiology prelim report verbally.  Patient hemodynamically normal.  Respiratory viral panel including Covid negative.  Concern for possible vaccine reaction.  Will be reported by pharmacy.  Seen by cardiology in the emergency department.  Will be admitted overnight for observation given concern for troponin still climbing as well as monitoring for arrhythmia.  Patient concerned about being admitted but willing to stay after further conversation.
incapacitated; Complete lack of energy; slept for 24 hrs almost straight; This case was reported by a consumer via interactive digital media and described the occurrence of disability in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced disability (serious criteria GSK medically significant), feeling of total lack of energy and sleepiness. On an unknown date, the outcome of the disability and feeling of total lack of energy were unknown and the outcome of the sleepiness was recovered/resolved.   It was unknown if the reporter considered the disability, feeling of total lack of energy and sleepiness to be related to Shingrix.  Additional details were received as follows: The patient's age at vaccination was not reported. Previously, the patient had received vaccine but was not effective as Shingrix.  After receiving 1st dose of Shingrix, the patient was incapacitated for 3 days, had complete lack of energy and was slept for 24 hours almost straight. The patient had prescription of Shingrix but vaccine was received late because patient's physician warned that Shingrix could cause flu like symptoms for 4 days. The patient considered that, Shingles was way worse than a mild case of flu and received vaccines. The patient complained to GlaxoSmithKline that they were misleading the patient's as the side effects listed were massive and debilitating. It is one of two cases, reported by the same reporter.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 06-AUG-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) lot # L000454, expiry date: 06-JAN-2017 (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
developed SOB and hives several hours after getting Tdap, Hep B and flu vaccine, has had Hep B and flu vaccine in the past, has had Td in the past
This spontaneous report as received from a medical assistant (also reported as healthcare worker) refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with (Oka/Merck) VARIVAX lot number for Vaccines for Children (VFC) Vaccines J008170, expiration date 02-JUL-2015 (dose and route were not reported) that had a temperature excursion. Patients were also vaccinated with improperly stored TD. No adverse effects were reported. The reporter was unable to provide any patient information or dates of vaccination. This is one of several reports received form the same reporter. Additional information has been requested.
Immunization given 10/17/02. Noted delayed swelling 8 days after vaccine. No immediate problem. Red, swollen 20mm nodule R thigh. Not injected minimal systemic. Treated with Motrin and oral steroid.
Received the vaccination on Friday afternoon and the next day, Saturday, Woke up with a slight fever. It increased over the day until 101 in the afternoon. Loss of appetite by 6 pm. Slept 11 hours overnight and fever gone in the morning. By Sunday the inoculation site was red and hot, redness stretched about 4" in length. Also, quite swollen lymph node under the same arm.
Around 7:30 PM on 1/11/2021, patient started to experience fever, diffuse sharp chest pain with body aches, and myalgias. Patient was COVID+ in October 2020. Patient presented to the emergency department and was treated as a sepsis alert and received fluids, ceftriaxone, and ibuprofen with good response. Labs were as follows: Bilirubin and transaminases are normal, D-dimer is normal, serum lactate is normal, EKG is nondiagnostic with prolonged QT, troponin is negative.
12:18 pulse 80 client taken to lay down on the cot.  C/O rapid pulse and shortness of breath.  Had patient lay down pulse88  1220 150/82  heart rate 80   1225 b/p 148/78  pulse78 1227 patient sitting up water given  12:38 b/p 130/82 respirations 12 pulse 80 patient states no further problems.  Was informed to seek medical attention with further problems.  Also given V-safe paper to contact for further follow up.
This spontaneous report was received from a physician via company representatives and from a support services director concerning to a patient (encounter key # 448029) of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications was not reported. On 21-NOV-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5ml SD-PFS LLok wTip" which had the lot # K009874 with expiration date 19-MAR-2016 (dosage number and route of administration were not reported). On an unspecified date, the vaccine had a temperature excursion for 40 hours in which the highest recorded temperature was 47 degrees Fahrenheit (8.333333333 degrees Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported and no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Approx 630 pm on 8/13/11 injection site very sore. Later pm on 8/13/11 severe body aches, chills, nausea, sore throat, headache & earache. Symptoms lessened by 700 am 8/14/11. As of 8/15/11 at 930 am still has sore throat, headache & severe body aches.
None; pt was accidently given comvax instead of DTAP.No adverse events reported.
Pt 1st noticed swollen glands 5MAR & 6MAR92 p/recvd vax; 7MAR92 felt tired; t101;
devel urticarial pruritic rash approx lt deltoid area; urticaria on proximal thigh & trunk;
Sm. multiple erythematous papular-macular rash on trunk and face. Approx 30-40 lesions, afebrile.
Acute appendicitis occurred.  I developed abdominal pain and fever on 3May2022. Uncontrolled chills and fever dominated the night. By morning most abdominal pain was gone but fever remained around 100-101. Went to Family Dr office on 6May2022 @ 1345 to determine if it may be appendicitis. After an exam was sent to local hospital for a CT. CT confirmed appendicitis and I was rushed to ER/OR for a laparoscopic appendectomy that night.
patient called and complain about itching at injection site and i recommend cold compress on the site for 15 mins and antihistamine
Patient was diagnosed with cellulitis from doctor's office, patient to complete a 10 day cycle of antibiotics.
Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: Swollen neck and swollen eye. Patient went to Doctor's office and got a prescription for Betamethasone cream which helped to reduce the swelling and symptoms. Told to take benadryl otc which made it worse. Patient stopped benadyrl and filled a prescription for betamethasone cream which helped to reduce swelling.
administered Pediarix and Pentacel on the same day; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number PE24L, expiry date 11-APR-2025) for prophylaxis.   Co-suspect products included PENTACEL for prophylaxis.   On 07-JUL-2023, the patient received Pediarix and PENTACEL. On 07-JUL-2023, an unknown time after receiving Pediarix, the patient experienced overdose (Verbatim: administered Pediarix and Pentacel on the same day). The outcome of the overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 07-JUL-2023 The reporter consented to follow up. The patient was administered Pediarix and Pentacel on the same day, which led to overdose.
Believe they tested positive; Believe they tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Believe they tested positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Reporter cannot confirm vaccine status of patient, but may be vaccinated (likely). Unsure when or what vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
No adverse event occurred, but patient was administered vaccine that was expired per BUD. The BUD was 11.26 @ 9:00am, but the patient was give the vaccine on 11.26 @ 9:44am. The manufacturer was contacted and their extended stability data showed the vaccine was ok to use, and no excursion occurred.
Patient received a vaccine after the Moderna vial had been punctured 20 times. Patient was the 22nd patient to get vaccinated from the vial. Moderna was contacted and informed of the incident.
Patient experienced sore arm, redness at injection site and swelling at injection site. This started the day after vaccination and has persisted through 1/7/22, slowly improving at this time but not fully recovered.
5/18/2006 Dx: Mild Chicken pox, discrete red, slight vesicle lesions scattered about
Complaint of bruising, redness and swelling injection site.  Seen at local hospital and given anti-inflammatory injection per patient
I had a strange taste in my mouth after the injection, which has never happened before, but didn't last long-no more than 15 minutes. Then different symptoms began 2 days after vaccination with severe soreness and redness at injection site, despite having had no soreness/redness since injection. The next morning it was still very sore and the redness was spreading and eventually spread to the backside of my arm and an inch or two above and below the site. That afternoon it started to itch, which worsened to the point of me being uncomfortable enough to take a Benadryl which helped. By the next afternoon/evening the itching stopped and the redness started receding. It was all gone by the next day.