chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Multiple kidney stone events during the month of August, 2021.  Worst attack began 8/29/21, lasting 10+hours.  Vomiting for 8+ hours.  Muscular injury of lower back as a result of severe vomiting.  Could not get out of bed morning of 8/31, due to severe back pain and kidney stone attack beginning. Transported to hospital ER and was admitted 8/31/21. Laser Lithotripsy was performed to break up kidney stones in left kidney. Kidney stone still present in the right kidney.  Urethra was blocked by post-op clotting, requiring temporary catheterization.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 34-year-old female. Neither medical history nor concomitant medications were reported. On 02-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.
next day after shot, I experienced blurred vision for most of morning, saw double eyes...the eyes were one over the other  and was hard to focus,  i used clear eyes to see if it would help, it did somewhat, still at this time, afternoon, it is still hard to focus, but not as bad.
pt states she has had muscle soreness and difficulty lifting arm since second dose of vaccination; seems to be improving but still having soreness a month later
Acute mono infection starting mid-March, a year after recovering from my first infectious mono case (lab confirmed April of 2020). Fever, chills, extreme fatigue for two weeks. Followed by months of fatigue, swollen lymph nodes, post-exertions malaise, headaches, brain fog/inability to concentrate.
had a feeling of being dragged down; I am confused; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Apr2021 (Lot number: EW0167) at the age of 72 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PREDNISONE (ongoing). Vaccination history included: Bnt162b2 (1st dose of the Pfizer COVID Vaccine on 05Apr2021 with lot ER8737), administration date: 05Apr2021, when the patient was 72 years old, for COVID-19 immunization, reaction(s): "I am confused", "a bit of weakness and felt weak". The following information was reported: CONFUSIONAL STATE (non-serious) with onset 2021, outcome "unknown", described as "I am confused"; VERTIGO (non-serious) with onset Apr2021, outcome "unknown", described as "had a feeling of being dragged down".  No follow-up attempts are possible. No further information is expected.
Upon injection, medication burned going into arm and lasted about 2 minutes.  I immediately started feeling odd over my entire body, I felt and looked flush,  felt clammy, muscle tightness,  started shaking, felt very nauseated, blood pressure went up and experienced slight swelling in hands.  This lasted 30-45 minutes.  My blood pressure, oxygen saturation level were being monitored.  I left office at around 12:00 pm feeling better.  I felt off the entire day.  At 6:00pm I started with chills, muscles aches and pains.  At 7:30pm I took a shower and went to bed very fatigued, muscles pain and cramping and chills. I took my daily meds of 125mg of Diamox, and 100 mg of Azathioprine.  At 11:30pm I woke up with a 104 fever, sweating, and a lot of muscle cramping in legs and feet.  My head felt like it was going to explode.  My cerebral fluid pressure was up and felt in head and down spin.  I did not rest well and found it difficult to get comfortable all night.  I took an 200 mg of ibuprofen at 12:00am and started to feel some relief.
swelling, discomfort, erythema of leg where vax given;eventually sx involved entire leg;no neurovascular compromise;no neuro sx;no fever;no hx trauma or insect bite;tx APAP, heat rx
Woke up saying she did not feel well.   Lethargy all day, sore throat, felt warm.  Next day aches and pains, low fever (100.4) and more lethargy.  This continued through Sunday.  Monday went to school but was tired and complained of sore throat.  Tuesday sore throat turned to laryngitis.  Wednesday we are going to the pediatrician.
Ankle swelling 1-2 weeks after, followed by pain throughout body, weight loss, fevers, night sweats. 6 months later granuloma (lumps) appeared throughout body. Biopsy 4/2004 diagnosed with sarcoidosis. 01/2005 granuloma became wounds.
This is reported by his mother.    Around 10:00 AM he got his vaccine.  Mother met him at 12:30 and went to lunch, said he felt OK.  She stayed with him a couple of hours, went home and apparently he went to sleep.  The next day he texted his mother and said that he felt yucky.  She told him to give it a couple of days, and he went to work all week, but said that after he ate he felt "funny".  Then on Sunday, Mother's day on 5/9/21 and they face timed and was supposed to meet him at 5:30.  At 12:45 he had finished eating, ate some enchilladas and said that he felt weird.  He said that he was going to be ok to meet him at 5:30.  At 4:37 PM she texted him to say that she was on her way to meet him.  She got at the meeting place at 5:30 and he was usually there before her, this is a normal weekend ritual to exchange his dog.  She waited 9 minutes and she tried to facetime him thinking he was in traffic, and he didn't answer.  She thought he was just not answering.  She then waited 9 more minutes and then called his phone and local Hospital answered the phone and asked who she was, and she answered the questions, and she told her to get to the hospital.  She went to the hospital and the doctor came in and told her that he had the car running and he went to the gas pump to get gas and he stepped out of the car and collapsed.  The person who saw him told the attended that he had collapsed and they called 9-1-1 and he was pronounced dead.  He worked in a warehouse and was doing well and about to be certified to be a forklift driving.  They said that they worked on him and that they could not get his heart started again.   They had to do an autopsy which is against her religion and she will not find out those results for 3-6 months.  She said that he was healthy and looking forward to get tested at work.  They told her that he had an enlarged heart and an enlarged spleen, and had never had any heart issues in the past.    He walked 20,000 steps a day in the warehouse.    He was living in a sober man's facility, he has been clean for 18 months.  He had an addiction to pain pills and Xanax.    She feels that there was something in the vaccine that had something to do with it as he was perfectly healthy before the vaccine.
Same day of vaccine - numbness and tingling in right chest, right shoulder, and upper right arm. Ended after 24 hours. Then in the days that followed - the numbness and tingling moved down to both legs - from buttocks down to the toes, with the most intense numbness and tingling in the both left and right lower legs, feet and toes. This is ha been persistent in both legs for 30 days now since getting vaccine, and is getting more pronounced each day. It is worse now than it was when it began.
This spontaneous report as received from a physician refers to a 63 years old female patient with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated intradermally with ZOSTAVAX (lot number not reported) on 11-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On 12-SEP-2012 the patient developed 4 cm diameter in induration and blister. The patient had sought unspecified medical attention. No laboratory diagnostics studies were performed. Antibiotics were given for treatment. The outcome of the events was unknown. The is one of two patients received from the same reporter. Additional information has been requested.
Information has been received from a nurse concerning a 12 year old male who on 02-MAR-2007 was vaccinated with the second dose of Varivax. There was no concomitant medication. On approximately 04-MAR-2007 the patient's upper arm was red (in between his elbow and up to his shoulder). Unspecified medical attention was sought. There were no laboratory tests performed. Subsequently, the patient recovered from the redness on his upper arm. It was reported that the patient had a similar reaction the first time he was vaccinated with Varivax. Additional information has been requested. Additional information indicated that the patient was vaccinated in the right arm with a dose of VARIVAX (lot # 655066/1141F) on 09-MAR-2007 (previously reported as 02-MAR-2007). It was reported that the patient had no known medical history. No further information was provided. No additional information is available.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-DEC-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB (exposed to the following temperatures and cumulative time frames colder than 36F: In September of 2015, the coldest temperature was 34F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34F for 192 hours, for a total of 1,031.3 hours (43 days)) with lot number: L010595, expiry date: 12-NOV-2016 (dose-0.5ml, strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
systemic rash starting 2 days after vaccination. Rash is raised and started on back, moved to abdomen, then ankles, legs. Rash is still present today.
Patient passed out approximately 5-10 minutes after  receiving vaccine. She may have hit her head while she was falling. She then had 2 seizures.  911 was called. Patient's blood pressures were 99/58 and 95/42.  Patient had only eaten granola bar and yogurt today.  She had also previously passed out while getting a tattoo.  Patient's mother was going to take her to hospital to get further treatment.
Redness and swelling to Right upper leg. Treated with Rx: Augmentin 500BID x10
Information has been received from a physician concerning an adult female who was vaccinated with two doses of varicella virus vaccine live (Oka/Merck). The patient sought medical attention and had varicella titers drawn for health care employment. The physician reported the results were negative for seroconversion. No other information is available at this time. A product quality complaint was not involved. Additional information has been requested.
High Temperature 101.8 deg F, Severe Body Ache, Shivering.  Recovered after 2 days.
Persistant deep pain in arms right greater than left.  Right is injection site for several months.  Eating well and pain, exercise and pain.
Lightheadedness, dizziness, blackout, temporary loss of hearing, chills and sweats.
Approx. 2 minutes after vaccines, pt. began to stiffen up and arms were flexed and jerking. Eyes open with dilated pupils. Pt. pale and clammy. Lasted <2 minutes. Pt. placed supine with legs elevated. Given juice and crackers. Monitored for 30 minutes and stable.
After receiving 3rd Hep B injection on 1/31/06 pt's mom reported that a small hardened area to site was noted. The hardened area has remained up to this day without complaint (no redness, soreness, pain or fever. After pt showered this am the site began to bleed. Mom applied pressure for 10 minutes along with pressure bandage. School nurse will check site today. Mom states if worsens will see family physician today. Mom verbally agreed to update health dept with any changes.
HIVES FRIDAY @12:00 PM FACIAL SWELLING AND  REDNESS  1/10 @9PM
pt recv vax 10AUG95 & 29OCT97 pt devel a mild case of chickenpox;No further info is available;
A few minutes after patient received Janssen vaccine he informed me that he was feeling dizzy and for a few seconds he felt like he was having trouble breathing.  He stated that vaccines cause him a lot of anxiety and that he has gotten nauseous in the past.  I continued to observe him at the pharmacy for another 20 minutes to make sure he was not developing an anaphylactic reaction.  I told him to call pharmacy if anything changes or go to ER.  After 20 minutes he said that he felt alright and thinks it was just anxiety that was making him dizzy and very briefly short of breath.
Information has been received from a physician concerning a patient who on an unknown date was vaccinated with a dose of GARDASIL. Subsequently the patient experienced joint and muscle aches. It was unknown if the patient sought medical attention. At the time of the report, the outcome of the patient was unknown. This is one of two reports received from the same source. Additional information has been requested.
Has growth on arm; This is a spontaneous report from a non-contactable consumer or other non hcp (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the patient had growth on arm and was worried she did not get the vax correctly into the deltoid muscle. She was wondering if she should get another one. She has HCP appointment today to determine is vaccine given in the right area. Outcome of the event was unknown.  No follow-up attempts are possible; Information on the lot/batch number could not be requested.
Fever of  100.3 for about 4-5 hours. General muscle aches for 24 hours +,  injection site soreness.
COVID-19 exposure after 1st dose, Positive COVID-19,  test after 1st dose; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (COVID-19 exposure after 1st dose, Positive COVID-19,  test after 1st dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19 exposure after 1st dose, Positive COVID-19,  test after 1st dose). At the time of the report, COVID-19 (COVID-19 exposure after 1st dose, Positive COVID-19,  test after 1st dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: other (Positive) Result: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or treatment details reported. Reported that he received the COVID vaccine first dose. Afterwards, he was exposed to COVID-19 at a work event and later tested positive. Caller was no longer on the line after transfer.
2/4  bruising at injection site, started having abnormal vaginal bleeding on 2/5- 2/12/21
After vaccines patient's fever gradually went higher throughout the day. I believe it stayed at around 104 but he was acting okay, the next day is when it hit 107 degrees and this is when we went to the hospital immediately. He was completely lethargic and looked like death. After some tests they learned he had bilirubin in his urine and his white blood cell count was very low and he had a UTI. They didn't ever find out what was wrong with him and sent us on our way with antibiotics. Since those vaccines our son has not talked, he was silent for almost a year and it took almost 8 months to get his diet back up to a healthy amount.
Woke with elevated fever at 3:00 AM. At highest, fever was 2.3 degrees above my normal. Loss of appetite.  Fever sweats. General discomfort. Slight pain in arm. Extreme fatigue. Treated with  two Tylenol and sleep.  Most symptoms disappeared within 24 hrs of the shot except for the following: one-degree temperature on the second  day (took more Tylenol); and extreme fatigue for nearly five days before it started to taper off. I was unable to perform normal daily activities during that time ,due to the fatigue, including my job.  Treatment: sleep, rest and time.
who got the vaccine and died three days later; This is a spontaneous report from a non-contactable other hcp. The reporter reported for herself and another patient. This was for another patient. A patient of unspecified age and gender received bnt162b2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got the vaccine and died three days later on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The causal relationship between bnt162b2 and the event death cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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.; Reported Cause(s) of Death: who got the vaccine and died three days later
2-4-10 9A Client called to report a bumpy, itchy rash that "smells infected" under L breast. Denies temp or pain. She noticed it 2-3-10.
fluzone high-dose quadrivalent being administered to a patient under 65 years of age (with no reported adverse event); Initial information was received on 06-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 60 years old female patient to whom fluzone high-dose quadrivalent being administered to a patient under 65 years of age (with no reported adverse event).   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-Oct-2022, the patient received 0.7 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot-UT7714AA and expiry 30-06-23) via intramuscular route in the left deltoid for immunization.  On 06-OCT-2022 the patient developed a non-serious fluzone high-dose quadrivalent being administered to a patient under 65 years of age (with no reported adverse event) (product administered to patient of inappropriate age) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken:not applicable.  At time of reporting, the outcome was Unknown for the event fluzone high-dose quadrivalent being administered to a patient under 65 years of age (with no reported adverse event).  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 the guidelines. 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.
A patient received an expired diluent of ACT-HIB, no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist.  This case involves a patient (unknown demographics) who received an expired diluent HIB (PRP/T) VACCINE [ACT-HIB] (lot U6567AA and expiry date: 01-Mar-2021) via an unknown route in an unknown administration site for prophylactic vaccination on 13-Apr-2021 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   The caller reported that the diluent was expired and the powder portion still within date, that the medication sent to the hospital floor from the pharmacy in a plastic bag out of the box and the patient had already been discharged from the hospital. Powder Portion: LOT: UJI66AA and  expiry date: 31-May-2021  This was a case of actual medication error due to expired product administered (latency same day).  At the time of reporting, 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 holders 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.
pt recvd vax 945AM & 10AM 1/8" wheal & flare (hives) noted on face & abdo total of 2; they faded & others appeared scattered on arms, trunk, neck; hives cont to appear & disappear until discharge;
After second dose of a 3 dose series, pt blood pressure increased from normal baseline of 100/60 to 185/135 approx 15-20 minutes after receiving the Gardasil. Pt had near syncopal episode. PT recovered very quickly after ward.
This spontaneous report was received from a registered nurse, concerning a 4 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 18-JAN-2019, the patient inadvertently was vaccinated with GARDASIL 9 for prophylaxis lot #158675 and expiration date 16-FEB-2021 (product administered to patient of inappropriate age) (strength, dose, frequency and route of administration was not reported), instead of  PROQUAD (vaccine not administered) (wrong product administered) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported). No adverse effects were reported.
Patient inadvertently received vaccine after expiration date. Moderna Company analyzed vaccine and advised lot 007B21A maintained activity necessary to protect against covid 19 at time of administration. Also patient did not call in with adverse event.  This is administrative error without adverse event.
Pt complained of onset of rash about 36 hours after receiving Pneumovax. Noted onset of red raised slightly itchy lesions on left side of face. Next morning she had lesions on the inner aspect of her left upper arm, under left breast, on chest, abdomen and back. Treatment with Benadryl as needed. Of note, pt went to Mexico 5/21-5/28/03.