chrisvoncsefalvay/vaers-outcomes huggingface dataset:
LUNG INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 INFECTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex, race, ethnic origin. 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, frequency one total, administered on an unspecified date in Apr-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date in Jul-2021, the patient caught the variant (suspected Covid-19 infection, suspected clinical vaccination failure), was pretty sick and the lungs got infected. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lung infection, suspected Covid 19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000191186.; Sender's Comments: V0: 20210854989- Covid-19 vaccine ad26.cov2.s- Lung infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210854989- Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Dizziness, numbness and tingling on face and arms, incresed heart rate (132) increased blood pressure (152/85), Shortness of breath, pain at injection site, pain in upper arm. symptoms appeared within 1 hour after injection and continued through the night. The following day the symptoms indcreased at 7am and er visit followed. Four days later arm is still sore, still having dizzy spells and increased heart rate and numbness off and on at left arm.
Difficulty Breathing, Mucus, Eye Discharge, Lethargy, Excessive Crying, Fever, Difficulty Sleeping, all until until 7 AM and later. Treatment- warm steam, cold vaporizer, rocking.
had an splenectomy; received 1st dose of  Menveo / DOB: 26-APR-1944; This case was reported by a pharmacist via call center representative and described the occurrence of splenectomy in a 77-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA440A, expiry date March 2022) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) (batch number ABXA95AA, expiry date February 2022) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th September 2021, the patient received the 1st dose of Menveo, the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 16th September 2021, an unknown time after receiving Menveo, Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced splenectomy. On an unknown date, the outcome of the splenectomy and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the splenectomy and inappropriate age at vaccine administration to be related to Menveo, Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received 1st dose of Bexsero & Menveo at 77 years of age, which led to inappropriate age at vaccine administration. After first doses of both vaccines, the patient had an splenectomy and now they are wondering if there was a window time to administer 2nd dose or any guidelines on how to proceed with this patient 2nd doses. The reporter consented to follow up.
I started to feel severe lethargy and fatigue. My eyes flared, double vision up with my usual autoimmune attack. I could not get out of bed for five days. Chills and back pain, joint swelling. It felt like a really flare up of my autoimmune condition. I also had similar problems with the first dose but not as bad.  I was midway between my bi-weekly Cosentyx.
Extreme fatigue Extreme chills Sore injection site Fever (101F) Headache These symptoms were temporarily fixed by OTC cold medicine but lasted for about 24 hours. All I have now (after 40 hours since the injection) is sore injection site.
Urticaria - diffuse, Persistent, saw her on 9/8/2021 and she still had urticaria, added 2 week course of prednisone
Uses an inhaler, has a hard time taking a deep breath; pain in her left arm pit; Injection site is red; Injection site is swollen; moved to more severe pain on her chest and left breast to the sternum; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included arthritis.   On 22nd August 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In August 2022, less than a week after receiving Shingrix, the patient experienced radiating pain. On 22nd August 2022, the patient experienced injection site erythema and injection site swelling. On 24th August 2022, the patient experienced difficulty breathing and axillary pain. The patient was treated with tramadol, oxycodone hydrochloride + paracetamol (Percocet) and medication unknown (Inhaler (Nos)). On 24th August 2022, the outcome of the injection site erythema and injection site swelling were recovered/resolved. On an unknown date, the outcome of the radiating pain and difficulty breathing were not recovered/not resolved and the outcome of the axillary pain was unknown.   The reporter considered the injection site erythema and injection site swelling to be related to Shingrix. It was unknown if the reporter considered the radiating pain, difficulty breathing and axillary pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 30-AUG-2022 Reporter's Comment: The patient received first dose of Shingrix into left arm and experienced injection site was red and swollen for the first couple days. The patient reported that pain in left arm pit started two days after injection and now it had moved to more severe pain on chest and left breast to the sternum. The patient used an inhaler and had a hard time taking a deep breath from the inhaler. The patient took Tramadol and Percocet patient normally used for her arthritis because the pain was so severe. The reporter did not consent to follow up. The caller does not give permission to contact her health care professional.
2 days after receiving tetanus injection in left buttock IM. Pt had redness, warm to touch, swelling, left groin tenderness.  4cm x 4cm redness at site of injection.
sharp pain @ site clearly differentiated from needle stick;rapid tingling & numbness from site radiating distally down dorsal side of arm but not down ventral sides;small rash @ site;
There was NO adverse reaction, the patient was inadvertently given the monovalent Pfizer as a Booster and should have received the Bivalent booster. the patient will need to return in 2 months for the bivalent booster.
Narrative: Pt received Johnson & Johnson covid vaccine 4/3/21. Next day had headache and fatigue. The next day had pain in hip sicket were old injury was. 4 days post vaccine had migraine and pain in scar tissue in right arm. 5 days post vaccine had diarrhea and abd pain which resolved.
Patient said she experience at injection site swollen, hard, hot, tender, painful, bruises. Sun-> Wed-> Red Rash and hives, itchy on face.
patient passed out after 5 minutes of vaccine administration for 10 seconds. Gave her water also some orange juice, waited in the store for another 30 minutes. She was fine when leaving.
Vaccine administered 8/19/09 at 09:05am.  Patient reported back to nurse approximately 10-15 minutes later complaining of feeling hot and red.  Then patient becamse pale and cool to the touch.  After 10 min of observation by nurse patient stated he felt fine and continued on to next appointment.  Patient state that he had not eaten since 5:30pm the evening before.
Nov. 6, 2011. Mother walk in to center escorted by an employee. Mother states child "broke out with rash over her body" after getting vaccines from the center. Mother states she didn't want to fill out report, "I'll take them to hospital" VAERS completed with info from immunisation record.
CONFIRMED COVID-19 INFECTION; A LITTLE STOMACH UPSET; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not 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-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 31-MAR-2021, the subject experienced a little stomach upset. On 07-APR-2021, the subject experienced confirmed covid-19 infection. Laboratory data included: COVID-19 virus test (NR: not provided) positive. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the a little stomach upset and confirmed covid-19 infection was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as the case is assessed non serious.
Tingling, in both feet legs/ Tingling, right hand.; Numbness in right fingers.; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the left arm on 31Aug2021 at 13:45 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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 COVID vaccine. Concomitant medications included hydrochlorothiazide (MANUFACTURER UNKNOWN) and amfepramone hydrochloride (DIETHYLPROPION); both for an unknown indication from an unknown date and unknown if ongoing. On 31Aug2021 at 19:00, the patient experienced tingling in both feet legs, right hand and numbness in right fingers. The events resulted in doctors or other healthcare professional office/clinic visit. It was unknown whether therapeutic measures were taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tingling in both feet legs, right hand and numbness in right fingers were not resolved at the time of this report.
Breakthrough Covid infection; Breakthrough Covid infection; Sore throat; slight cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the parent.  A 18 year-old male patient received bnt162b2 (BNT162B2), administration date 29Jun2021 (Lot number: EW0181) at the age of 18 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included Bnt162b2 (Dose: 01, Lot No EN0217), administration date: 08Jun2021, when the patient was 18 years old, for Covid-19 immunization. The following information was reported VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Dec2021, outcome recovering; OROPHARYNGEAL PAIN (non-serious) with onset 26Dec2021, outcome recovering; COUGH (non-serious) with onset 26Dec2021, outcome recovering. The patient underwent the following laboratory tests and procedures sars-cov-2 test (27Dec2021) positive, Nasal Swab. Advil was taken as the Therapeutic measures as a result of vaccination failure, covid-19, oropharyngeal pain, cough.  Patient was detected Covid positive on 28Dec2021. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination.
Severe chills. Tips of fingers numb. Nausea / vomiting and headache.
I noticed a worsening of my symptom following the third dose and new patches of Psoriasis appeared in 14July2022. Clobetasol stopped managing my symptoms and no dietary or stress have occurred.
ACUTE RESPIRATORY FAILURE 4/25/2023 SHOCK, UNSPECIFIED  SHOCK, UNSPECIFIED 4/25/2023 SHOCK, UNSPECIFIED
feel sick; Initial information received on 12-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves a patient (unknown demographics) who feel sick (malaise), when received INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient feel sick (malaise) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
pain; This is a spontaneous report from a non-contactable consumer. A patient of an unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of COVID-19 vaccine on an unknown date for COVID-19 Immunization. On an unspecified date (after administration of the vaccine), the patient experienced pain. The outcome of the event was unknown.   No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained. No further information is expected.
Immediately after she had walked out of the vaccine room, she had experienced severe muscle pain in the injection site. Once home that night, she could hardly lift her arm above her head. As days progress, the pain started to radiate throughout her left arm at different sites, as well as her left lower back.  After a few days, she was able to lift her arm above her head but she cannot lift her elbow . 2 weeks still, she is experiencing pain and cannot lift her elbow.
Nausea, sweating, dizziness.  BP 73/50, heart rate 43
15-20 seconds after injection became diophoretic, lightheaded, passed out for 15-20 seconds.  C/o swelling in throat and throat soreness, no SOB or pain.  No visible swelling in throat.  C/o ringing in ears.  Symptoms quickly resolved.  Xyzal 5mg given.  Pt states "fine" within 10 minutes, released to home.
Approximately 2 minutes after COVID-19 Moderna vaccination 0.5ml injected, patient fainted in the chair located in our 15 minute waiting area.  RPh was called to respond.  Patient was unresponsive upon arrival.  Pulse present and strong, breathing appeared normal.  Patient was aroused by touch and voice.  Upon arousal patient was lethargic but could indicate name and DOB.  Patient verbalized feeling warm, faint, and nauseated.  Care was administered by visual monitor, cold compress to neck and forehead, water, and fan placed near patient. Patient's girlfriend was present and was a diabetic and took patient's BS reading with her own glucometer.  BS was 98. Patient vomited x 1.  Took approximately 50 minutes for patient to be fully awake and ready to try standing.  Upon standing patient was steady on the feet.  Patient was advised to discuss reaction with primary care provider and was assisted, when ready, to the door.
Approx 530PM 14FEB91 developed temp to 102(a) - high pitched unconsable crying; took to ER @ 1230AM; Ears & throat neg but throat culture taken. Started on Amoxicillin. Continues 102 fever & not drinking; Has URI @ this time.
My upper left arm began to be sore as you might expect after the vaccination. It has continued to hurt more and more over the past few weeks. Sitting still the pain is a dull discomfort over the upper arm area. When I move my arm over my head the pain increases significantly to the point of causing me to stop whatever I am doing (putting something on a shelf, undressing, etc.).
Vaccine given Thursday afternoon. Saturday morning had fainting spell. Vision and hearing lost before collapsing and fainting. After a few seconds came to and was disoriented and tired and then shortly recovered. I have no prior history of ever fainting or loosing consciousness.
This spontaneous prospective pregnancy report was received from a register nurse referring to a 30 year old female patient. On 16-OCT-2018 the patient was vaccinated with M-M-R II lot # N024701, subcutaneous for prophylaxis. Concomitant therapies included sterile diluent (DSM). The patient became pregnant with LMP of 07-AUG-2018 and EDD of 14-MAY-2019. Initial exposure to M-M-R II was at 10 week(s). The pregnancy outcome was outcome pending. On 16-OCT-2018, the patient experienced exposure during pregnancy and experienced product use issue.
As soon as I arrived home I noticed the sound was louder.  I was very distressed already having experience with Tinnitus.  The next night on the news i heard that  an increase of cases of Tinnitus after the shot and also as I had and increase in loudness.
Pt initially had diffuse joint pain, then worsening pain and swelling in RLE.   Had DVT u/s + for DVT No history of blood clots, no prior risk factors Cannot be certain that she did not have clot prior to vaccine, although she never had pain or swelling to this degree (1-2 mo prior thought skinny jeans were slightly tighter on R than L, but no visible swelling.  Now with RLE 2x size LLE)
I have had severe tinnitus since Dec. 29, 2021. It is unbearable at times and has interfered with my ability to live a normal life, enjoy reading or watching television.  It sometimes interferes with my ability to sleep as well.  I have had minor tinnitus in the past but it has never ever been this loud or intrusive before.  This is constant and irritating to the point of insanity sometimes.  Nothing relieves it.  Not driving or listening to music or watching TV.  Nothing drowns it out at all.  I live with it 24 hours a day since it started. I have not yet seen a doctor because I know there is really nothing that can be done for it but I will probably go to an ENT soon just to test my hearing and ask if they have any suggestions for relief.
Adverse reaction began the next morning after vaccine with extreme lower right hip Sciatica extending through the hip and down right leg.  Later that day and evening could barely walk from severe pain.  Never before experienced anything like this so severe.  Mild headache.  The following day, 2nd day after vaccine, mostly lower back pain, fatigue and head 'thickness'.  The next day, 3rd day after vaccine, most severe Transverse Myelitis and bed ridden all day.  Could not stand up due to intense torso pain.  The next day, 4th day after vaccine, mild neck pain and generalized body aches and fatigue.   Sciatica and Myelitis have subsided leaving only mild discomfort. The following days up though today, 18 days after vaccine, developed mild, itchy skin rash around neck and shoulders.  Continue mild headache, head 'thickness',  and mild body aches and fatigue.  Also have developed Erectile Dysfunction.  No erections during sleep or early morning as is usually the case.    This sequence of symptoms is reminiscent of similar symptoms I felt enduring Viral Meningitis over 40 years ago at 27 years of age.
Patient admitted with encephalopathy,  rhabdomyolysis, lactic acidosis, troponin elevation. Note the presence of other medications, ie ambien and neurontin that may have contributed to her illness
swollen lymph node; painful spot I believe it's the lymph node under my arm; This case was reported by a consumer via interactive digital media and described the occurrence of enlargement of lymph nodes in a 59-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th April 2022, the patient received Shingrix. In April 2022, less than a week after receiving Shingrix, the patient experienced enlargement of lymph nodes and lymph node pain. On an unknown date, the outcome of the enlargement of lymph nodes and lymph node pain were unknown.   It was unknown if the reporter considered the enlargement of lymph nodes and lymph node pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-Apr-2022 Reporter's comments: This case was received from interactive digital media. This case was reported by the patient. The patient received Shingrix on the day before the reporting and had very painful spot which the patient believed as lymph node under arm. The patient experienced swollen lymph node.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: patient fainted within 2 minutes after injection, EMT came and checked patient who came to within a few seconds
He had an episode at school in which he fell from his chair and was seen to have a "seizure" for a few seconds.  Jerking movements reported to look like a seizure. Mom was called to school and when she arrived patient seemed sleepy but reports that he has since returned to his neurologic baseline.  No prior history of seizures. No family history of seizures.  Reported a front headache but says no headache currently.  No fever.  Seems like himself to parents. No recent complaints of headaches.  No vomiting. No meds given.  Unremarkable morning before school.  Parents report he had a normal day yesterday although he did take a nap which is a little out of character but they had been at a party the night before. Seen at ER. c/o headache at ER. Parents report that patient had an esotropia before but feel that it is currently "a little more prominent than they remember."
Pt experienced injection site edema with pinpoint contusion 24 hours post vaccination. Pt also experienced limited mobility.