chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Echocardiogram results moderate circumferential pericardial effusion; Fever; stomach pain; congestion; cough; Xray showed enlarged heart.; This is a spontaneous report from from a non-contactable consumer (patient). A 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 02Apr2021 (Batch/Lot Number: 7533) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included down syndrome. The patient also reported sulfa drugs (unspecified). Prior to vaccination, the patient diagnosed with COVID-19, however since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications (reported as other medications the patient received within 2 weeks of vaccination) includes: Topiramate, Buspirone, Mirtazapine, Synthroid, all taken for an unspecified indication, start and stop date were not reported. It was reported that the patient experienced Fever, stomach pain, congestion, cough, Xray showed enlarged heart and Echocardiogram results moderate circumferential pericardial effusion, all on 09Apr2021. The events resulted in Doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures which included echocardiogram: pericardial effusion (moderate circumferential pericardial effusion) and x-ray: showed enlarged heart, both on 09Apr2021. The outcome of the events was recovering. Treatment include: antibiotic, prednisone.   No follow-up attempts are possible. No further information expected.
Patient developed lethargy and a temperature of 101 for 1 day. She slept all afternoon on 5/19.
Febile seizure called 911 and was taken by ambulance to the emergency room, when they got to the er the fever was gone and he was not having a seizure.
Within 15 minutes of injection the employee began to experience eyes burning and instant headache, lightheadedness, face itch numb and burning, face turned red immediately. She was taken to the urgent care center on the campus and evaluated by medical providers who ordered oral medication and she was d/c to home the same day.    She had chills later in the day The next day she was fatigued and slept a lot. She was able to return to work as scheduled on the 3rd day.
Extreme rapid pain in vulnerable joints. Joints were temporarily frozen (?paralyzed?) and could not move Lasted through day but improved following morning.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. In April 2014, the patients were vaccinated with doses of GARDASIL (Lot # J011272 exp date 21-APR-2015) (doses not reported) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
cellulitis/allergic reaction  left deltoid two hours to DTaP and/or IPV injections
Information has been received from a physician concerning a 15 year old female patient with anxiety and penicillin allergy and a history of febrile convulsion at age nine and high pitch cry after diphtheria toxoid (+) tetanus toxoid vaccination on 27-DEC-1995, who on 09-DEC-2010 and on 06-JUN-2011 was vaccinated with the first and second doses of GARDASIL (lot numbers: 666987/1016Z and 669265/0181AA, respectively). Concomitant therapy including ZOLOFT. There were no concomitant vaccines administered on 06-JUN-2011. The physician reported that ten days after receiving her second dose of GARDASIL, on 16-JUN-2011, the patient experienced tonic clonic seizures. Two weeks later, on 05-JUL-2011, the patient experienced a second seizure and was taken to the Emergency Room. The patient was not admitted to the hospital. A magnetic resonance imaging (negative) and an electroencephalogram (negative) were performed. No seizure disorder was reported. The patient was given KEPPRA as a treatment for the adverse event. The seizures improved on therapy. At the time of the report the patient was recovering. The patient would continue to be followed up by a neurologist to stabilize KEPPRA use. Upon internal review, tonic clonic seizure and second seizure were considered to be other important medical events. Additional information has been requested.
patient ent was administered 0.5 ml of YF-Vax that had expired in the left upper arm with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a other health professional (nurse).  This case involved a 40 year old male patient who received 0.5 mL dose of suspect YELLOW FEVER VACCINE - US [YF-VAX] [lot number: UJ090AA] via an unknown route at the left upper arm for prophylactic vaccination which was expired on 08-Jan-2021 (expired product administered).  Medical history, medical treatment, vaccination, family history and concomitant medication were not reported.  It was a case of actual medication error due to expired vaccine used.   It was reported that, no other medications or vaccinations were given at that time.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient received a dose of vaccine that may be less than completely effective due to storage conditions.  No adverse effect reported.
Information has been received from a physician concerning a 11 year old female who on 10-APR-2007 was vaccinated with Gardasil. Concomitant therapy included tetanus antitoxin USP. On 11-APR-2007 the patient experienced a sore arm, nausea and vomiting. This is one of two reports received from the same source. Additional information has been requested.
Initial report received from a parent (who is also a nurse) in the USA on 09 May 2007. An 18 year old, female patient experienced pain spreading up to neck and down top of arm after she received Adacel (lot number and route of administration not reported) on 30 April 2007. The reporter stated the vaccine appeared to be administered high on the arm, in the shoulder area (in the shoulder joint) and the patient experienced the pain as soon as the vaccine was given. It was reported the pain was becoming progressively worse. At the time of the report, the patient had not recovered.
Headache and moderate swelling (no pain) just above left collarbone. Flu vaccine was given in the left arm.
Significant worsening of tinnitus.; This is a spontaneous report from a non-contactable consumer, the patient. A 58-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 27Feb2021 at 07:45 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 28Feb2021, the patient experienced significant worsening of her tinnitus. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event significant worsening of tinnitus was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
pt recvd vax 27SEP93 & devel a fever of 104; the following day pt was afebrile; 30SEP93 fever returned & was 101; there was no lymphadenopathy;
Felt like a restless leg or blood clot but not as severe.; Felt like a restless leg or blood clot but not as severe.; Left below knee pain and discomfort. Some to the right leg as well.; Left below knee pain and discomfort. Some to the right leg as well.; Checked back of leg for warmth or bruising lasted day 2 and day 3.; Checked back of leg for warmth or bruising lasted day 2 and day 3.; Did feel some discomfort to left arm as a result of the shot in left arm, tender and could feel when holding arm up some discomfort; This is a spontaneous report from a  contactable  nurse reporting for herself.    A 49-years-old female patient started to receive bnt162b2 (BNT162B2; Lot: ECO142) vaccine , intramuscular in the left arm on 29Dec2020 15:45 at single dose for Covid-19 immunisation .  Medical history included hypertension, anaemia, blood cholesterol increased , depression, food allergy (whey casium)  (taking doxepin for it with relief).  Concomitant medication included doxepin (DOXEPIN), metoprolol (METOPROLOL), calcium ascorbate (VITAMIN C [CALCIUM ASCORBATE]), tocopherol (VITAMIN E [TOCOPHEROL]), cyanocobalamin (VITAMIN B-12) , atorvastatin (ATORVASTATIN), sertraline (SERTRALINE).   The patient experienced felt like a restless leg or blood clot but not as severe.  on 30Dec2020 07:00 with outcome of recovered , left below knee pain and discomfort. some to the right leg as well. on 30Dec2020 07:00 with outcome of recovered , checked back of leg for warmth or bruising lasted day 2 and day 3.  on 30Dec2020 07:00 with outcome of recovered , did feel some discomfort to left arm as a result of the shot in left arm, tender and could feel when holding arm up some discomfort  on 30Dec2020 07:00 with outcome of recovered.  The event blood clot was considered serious (Important Medical Event). Course of the events The patient reported left below knee pain and discomfort. Some to the right leg as well. She checked back of leg for warmth or bruising lasted day 2 and day 3. She felt like a restless leg or blood clot but not as severe. She felt better to stand instead of sitting. Did feel some discomfort to left arm as a result of the shot in left arm, tender and could feel when holding arm up some discomfort. No shortness of breath, no nausea, no dizziness, no increased fatigue (baseline - not enough sleep - working 3 jobs).; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported leg thrombosis cannot be excluded.  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.
I was extremely tired on Saturday. My shoulder hurt. About 3 pm, while urinating, I felt very light-headed as if I was about to faint. I stopped urinating and went back to bed.  That evening, about 8:30, I tried to eat dinner, but after three bites, I felt extremely tired. I leaned back in my chair, and I passed out. My wife woke me, but it took several minutes. She said my eyes rolled back in my head. She splashed water on my face. She said that I stopped breathing.  I woke up, then pushed my plate away and put my head on the table. I could not hold it up. I was sweating profusely. After several minutes, I felt that I was about to have diarrhea. My daughter and wife tried to walk me to the bathroom, but I did not have the energy to get there. I collapsed in the hall and hit my head on the door jamb. After several minute of trying , they pulled me up, and I then got the strength to walk the rest of the way. I had diarrhea, not suddenly, but it was as if my GI system emptied. It was soft, not loose, and there was a lot.  I went back to bed, and eventually slept.  I felt queasy the next day (Sunday), and I felt lightheaded at times, so I just sat or laid down. But I was feeling better. Today (Monday) I feel much better. A little tired, but much better. I went to the Pharmacy this morning, and they referred me to this website. I did not see the doctor.
Itching; tingling of the tongue and lips; Weeping; itching of face around mouth; tingling of the tongue and lips; This is a spontaneous report from a contactable consumer (patient herself). A 55-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in arm left on 10Mar2021 15:00 as dose 1, single for COVID-19 immunization (at the age of 55-year-old). Medical history included asthma, anxiety and hypertension. No known allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not had any other vaccine in four weeks. The patient did not had COVID prior vaccination. On 10Mar2021 16:00, the patient experienced itching, tingling of the tongue and lips, weeping and itching of face around mouth. The patient did not took any treatment for adverse events. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient been tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: negative (mouth swab). The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Administered with expired COVID vaccine; Error resulting in administration of expired COVID vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with expired COVID vaccine) and EXPIRED PRODUCT ADMINISTERED (Error resulting in administration of expired COVID vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with expired COVID vaccine) and EXPIRED PRODUCT ADMINISTERED (Error resulting in administration of expired COVID vaccine). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered with expired COVID vaccine) and EXPIRED PRODUCT ADMINISTERED (Error resulting in administration of expired COVID vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  As per the reporter, there were no symptoms or quality issue to report.
pt recv vax & exp neck pain & a fever of 103; No further details were provided;
Patient was administered Pfizer COVID-19 series one vaccine on 8JAN2021. Upon receiving the vaccine IM in his L arm the patient noticed pain at injection site which is an expected side effect of Pfizer COVID-19 Vaccine. Patient reported to his Primary care facility on 15 Jan 2021 with Limited Range of motion  and continued pain in L arm. Patient was unable to lift his left Arm higher than aprox 20-40 degrees without significant pain. Patient returned to primary care clinic on 22 JAN2021 with the same symptoms with no improvements.  Patient has been referred to physical therapy and prescribed naproxen in hopes of alleviating the issue.
Information has been received from an RN concerning a pt who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot 637369/1043L). Subsequently, the pt developed swelling and pain at the injection site and in the non-injected arm. Medical attention was sought. At the time of this report, the outcome of the events was unknown. Additional information has been requested. Related WAES 01112519.
Suspected vaccination failure; got it after/ the shot; debilitating pain; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient's friend. The age at vaccination was not reported. The patient got the Shingle shot and got shingles.  The reporter stated that they were painful and over two months of debilitating pain. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case is one of the 8 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178234:Same reporter US-GLAXOSMITHKLINE-US2021AMR178222:Same reporter US-GLAXOSMITHKLINE-US2021AMR178106:Same reporter US-GLAXOSMITHKLINE-US2021AMR178101:Same reporter US-GLAXOSMITHKLINE-US2021AMR138446:Same reporter US-GLAXOSMITHKLINE-US2021AMR179366:Same reporter US-GLAXOSMITHKLINE-US2021AMR179350:Same reporter
I got the shingle shot and 6 months later I got shingles/Suspected vaccination failure; I got the shingle shot and 6 months later I got shingles; Very painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected  vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 6 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient got Shingles after vaccination which was very painful. The patient used lacaine patches which help a lot to the patient. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation, time to onset of shingles were unknown at the time of reporting.
mom states pt had a hive like red rash on front of trunk area lasting until 22JAN96;no temp or itching;had eaten large quantities of strawberries on 19JUL96;no prior rxn to vax or strawberries;
10/01/02 Outbreak of chicken pox lesions; started 2 days ago with fever.
T started about 1PM.Had APAP @ 11am.T was no higher than 102 during 48 hrs. Started high pitched piercing scream from 1pm-430pm.Talk to MD-cool bath & APAP.Come in next day for evaluation.MD felt rxn to "P" in the DTP.
Itchy rash on upper and lower extremities bilaterally, relieved with benadryl
aching; tiredness; Threw up; Vaccination failure; shingles; Itchy rash; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (multiple outbreaks of shingles in the past, though this was the first this year).   On 12th June 2019, the patient received the 1st dose of Shingrix (intramuscular). In August 2019, the patient received the 2nd dose of Shingrix. On 8th November 2019, 149 days after receiving Shingrix and less than 3 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and itchy rash. On an unknown date, the patient experienced pain, tiredness and vomiting. On an unknown date, the outcome of the vaccination failure, shingles and itchy rash were unknown and the outcome of the pain, tiredness and vomiting were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and itchy rash to be related to Shingrix and Shingrix. It was unknown if the reporter considered the pain, tiredness and vomiting to be related to Shingrix.  Additional information was reported as follows: One day after 2nd dose of Shingrix, the patient experienced aching, tiredness and threw up. The patient had broke out in an itchy rash which was identified as shingles.
Pt is a 4 year old boy who would turn 5 between dose 2 and 3 of 6m-4y Pfizer primary series.  For that reason, in accordance with standing order, pt received Pfizer 5-11 as dose 1 three weeks ago per mother's educated choice.  Today, pt received his 2nd dose as Pfizer 6m-4y.  Provider was contacted and advised to administer the Pfizer 5-11 dose to complete the series at no minimum interval, per regulatory authority.   Mother was educated on risks/benefits/symptom management and agreed for pt to receive Pfizer 5-11 dose today as well.  Pt received Pfizer 5-11 dose and series is complete.
Information has been received from a physician concerning a 12 month old male patient who on an unspecified date was vaccinated with a dose of MMR II (lot number not reported) (reported as number doses received zero). On 16-NOV-2009 the patient experienced mumps. On an unspecified date the patient experienced orchitis. The patient was diagnosed on 06-DEC-2009. It was unknown if the patient was febrile. The outcome of the patient was not reported. Follow-up information was received which reported that on 25-DEC-2009, the patient developed right parotitis with a body temperature of 103. It was diagnosed on 28-DEC-2009. On 28-DEC-2009, the patient's IgM was <1:10, serum immunoglobulin G was 6.58 and serum amylase was 895. The outcome of the patient was not reported. This is one of several reports from the same source. Additional information is not expected.
Smallpox vaccine received on 2/5. Take assessment done on 3/4/03. Has a good take. On 3/12/03, called nurse to report a "rash" which itched. Stated it had started on 3/8, first appearing on her left leg. Also reported that the rash had now spread to ankles, across back and arms. Rash is macular-papular with no pruritus or vesicles and no drainage. Monitor closely for any progression or resolution. No further treatment prescribed at this time. She is off work until Monday 3/17/03 and to be seen by doctor before returning to work. On 3/14/03, tried to contact client at home, not available, message left.
This spontaneous report as received from a Licensed Practical Nurse via company representative refers to a 19 year old patient. On an unknown date, the patient received one dose of GARDASIL when patient was 14 years old. On an unknown date, same unspecified patient received one dose of GARDASIL 9 when patient was 19 years old. No adverse effects reported. No product quality complaint was involved.
Arm hurt, red and hot place to elbow on arm, large knot formed at injection site, muscle aches, lymph nodes underneath arms welled, armpit has two knots and is red.
Nausea, Foggy Brain. Started about 12 minutes after injection & lasted about 4 hours.