chrisvoncsefalvay/vaers-outcomes huggingface dataset:
allergic reaction; Initial information was received on 16-Sep-2023 regarding an unsolicited valid Legal case non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender of patient who experienced allergic reaction after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a unknown dose of suspect influenza vaccine (produced by unknown manufacturer) (formulation, strength, expiry date, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunization). There will be no information available on batch number for this case.  On an unknown date the patient developed allergic reaction (hypersensitivity) (unknown latency) following the administration of influenza vaccine.  Reportedly "I can't take the fly shot. Every time I had one I had an allergic reaction to it so I quit taking them in 1996 .Since this is a public post on the Sanofi flu shot campaign, we are assuming the consumer is referring to the Sanofi flu vaccine. "  It is unknown if there were lab data/results available.   Action taken with influenza vaccine was not applicable.  No corrective treatment was received for the event (allergic reaction).  At time of reporting, the outcome was Unknown for the event allergic reaction.
High fever 102.8, severe chills with rigors and ice cold extremities (hands and feet), body ache with pain in back and upper spine area, very bad headache, abdominal pain. Most severe symptoms lasted 48 hours, headache lasted 4 days.
Patient received Pfizer COVID-19 vaccine expired 08/11/2022 (4 days ago).
At Hepatitis A Outreach, box of Hepatitis A vaccine in cooler was pediatric instead of adult. Used vial of pediatric instead of adult to vaccinate adult. Will receive repeat #2 dose in Dec 2018 Clinic.
Died since taking your COVID vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), 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: DEATH (death), outcome "fatal", described as "Died since taking your COVID vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300020087 same reporter/drug/event, different patient.;; Reported Cause(s) of Death: Died since taking your COVID vaccine
Localized swelling, redness, firmness at injection location, measuring 2.5 inches x 1.5 inches appearing 8 days after the injection. Duration persisting for almost 24 hours and increasing  in size since first noticed nearly 24 hours ago. I am taking Benadryl tablets as a precaution to minimize swelling and slight itchiness.
General feeling of body aches; low grade fever; headache; This is a spontaneous report from a contactable consumer (patient). A 52-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL3247) via an unspecified route of administration on 22Feb2021 (at the age of 52-years-old) in right arm as a single dose for covid-19 immunization. The patient's medical history, known allergies to medications, food, or other products were reported as none and concomitant medications were not reported. The patient did not receive any other vaccine within four weeks or any other medications within two weeks. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient had not been tested for covid-19. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; lot number: EL3247) on 03Feb2021 in left arm for covid-19 immunization. The patient experienced general feeling of body aches, low grade fever and headache on 22Feb2021. The symptoms occurred within 12 hours of second covid-19 vaccine dose. The patient did not receive any treatment. 48 hours after dose, the symptoms significantly lessened and were almost gone. The outcome of all the events was recovering.  No follow-up attempts are needed. No further information is expected.
4 1/2 year old male-healthy at office after p.e. pt was given the shots MMR-IPV and DTaP. pt started with sneezing-rhinorrhea-tachycardia-dizziness-palenes-wheezing. Pt was given albuterol antihistamine, steroids and monitor with pulse orymetry
Patient leaned over to look at something on floor and had a syncopal event.  Fell off exam table hitting floor.
She's been having the chills real bad. It started last night in her sleep.; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (She's been having the chills real bad. It started last night in her sleep.) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (She's been having the chills real bad. It started last night in her sleep.). At the time of the report, CHILLS (She's been having the chills real bad. It started last night in her sleep.) outcome was unknown.            No Concomitant medication information was reported. No treatment medications were provided.
Patient given injection, left pharmacy area to return about 20-30 minutes later complaining of flushing, and severe dizziness. NO complaints of rash, itching, swelling, wheezing. Patient heart rate and blood pressure was elevated. Patient was very anxious about possibility of allergic reaction and was given oral benadryl. Continued to monitor, patient had another bout with flushing, severe dizziness and complained that her tongue felt funny. We then called 911. 911 monitored and evaluated patient. Patient eventually calmed and left along with her husband with instructions from 911 that if situation changed for the worse to proceed to ER.
Patient was given the vaccine and afterwards parked in the post vax lot.  Within two minutes of the vaccine being administered the patient's girlfriend honked the horn for assistance.  When I approached the vehicle I could see that the patient was shaking with body tremors, very pale, eyes rolled back, sweating.  Episode lasted for around 10 seconds.  At this time emergency services was called by scriber.  Patient came to I was able to communicate and I was able to talk to him. Pulse was normal.  Around 60.  Cold bottle of water was placed behind the patients head  while we waited for ambulance.
Hives all over body. Progressively got worse. Went to ER on 6/9/2012 after trying oatmeal baths, calamine lotion, Benadryl, and nothing on skin. Kept spreading. Treatment is Prednisone (5 days) and Benadryl as needed for intense itching.
Patient developed large red welt at injection site, claiming it's not itchy but very hot to the touch. MD recommended treating with ice and BENADRYL.
after shot #2.  8 hours after shot began to feel funny.  went to bed at 7:00pm.   fever, chills, heart palpitations, weak, unable to walk,     woke up 22 hours later and then felt 95% OK 3 hours. later.     since second shot my digestive system has been abnormal.  eating amount was reduced,  stomach was bloated,  BM were spermatic,      started an over the counter Probiotic in september 2021 and it is helping
Felt ill and feverish the day following injection (3/9/21) with a very sore arm. Symptoms worsened around 12:00pm, and took 1000mg Tylenol and did not feel much relief. Around 8pm I took my temperature and it was 103.6 orally. I took it a second time and it remained 103.4. Fever broke overnight and today (3/11/21) I am still fatigued but have a normal temp and arm soreness has improved.   (I contacted the Health Department prior to reporting this and they said to go ahead and report.)
This spontaneous report was received from a physician refers to a 10 year old male patient. The patient has seasonal allergies. The patient has no pertinent medical history. On 03-AUG-2013, the patient was vaccinated with second dose of 0.5 ml VARIVAX (Merck) (lot number, expiry date was not reported and the route was subcutaneous). Concomitant medications were none. Approximately on 07-AUG-2013, the patient developed varicella type rash on the abdomen give days after receiving second dose of VARIVAX (Merck). Treatment rendered for the event was calamine lotion. There was no laboratory studies performed. The outcome of the event was unknown. The patient sought medical attention. This is one of two reports received from the same reporter. Additional information has been requested.
After 5 min of receiving shot, in right arm,  my right lung began to feel painful.  When I am in an environment (house) with someone that has dogs/cats,  I will have this same feeling.. allergic reaction to the animal dander.   This happens if I am in the environment more than 2 hours, and after leaving the environment, the reaction dissipates  from 2 to 6 hours  later.      The reaction I had after receiving the shot was the same as above.  Also, during sleep, my Left lung at times feels a crushing sensation.. it dissipates once I lay flat on bed for a minute or two.  The sensations continue to this day, the pain if felt from front to the back of my lungs.
This spontaneous report was received from a Nurse, referring to a male patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were unknown by reporter. In approximately 2016 (reported as "one or two years ago"), the patient was vaccinated with a dose of GARDASIL 9 (route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis. After an unspecified amount of time in the office, the patient experienced syncope, and no treatment or medical intervention was performed. The patient was reported to be "ok after a few minutes" on an unspecified date in 2016. The Nurse did not mention the causality assessment between the event and therapy with GARDASIL 9. Upon internal review syncope was determined to be a medically significant event.
BURNING PAIN STARTED SUNDAY.  WEDNESDAY RASH APPEARED. DIAGNOSES THURSDAY (2/4) SHINGELS RASH CONTINUES TO SPREAD AND PAIN IS SEVERE.
Stomach pain and diarrhea and body weakness and arm pain and soreness of injected arm
patient presented with  delayed localized reaction one week post reaction - redness, warmth, and pain to the touch. she did not report reaction after initial injection but this was a delayed reaction she is now experiencing.  she  did not take any medications to treat symptoms.  she was advised to seek medical evalauation in the emergency room for this reaction.
Client received 0.5 ml dose as booster dose instead of 0.25 ml dose of Moderna on Friday 11/19.  F/u  on 11/24 -Reports that she had a sore arm for a few days, but otherwise feels fine. No additional questions at this time.
Patient accidently received a second prevnar 20 vaccine 10 days apart. patient expierenced no adverse reactions and 'does not care she got a second one'
RN GAVE A DOSE OF .6CC VS THE .3CC DOSE THAT SHOULD HAVE BEEN GIVEN. DUE TO MISCALCULATION
After the shot I did get a reaction only on my left arm.  It was a burning sensation with a rash.  Eventually that went away.  Around 10 days later I broke out in hives all over my body which were painful.  I went to urgent care and was prescribed prednisone which I took 40 mgs. for 5 days.  This lasted for a week and just stopped.  I still have the spots but they are fading.  I also had a swollen lymph node under my left arm.
felt pressure in the head; nodules between throat and clavicle; Pain in the legs; Pain in the lower back; I was in bed; Lot of headaches; Fever between 38.7 and 38.8 C; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (felt pressure in the head), NODULE (nodules between throat and clavicle), PAIN IN EXTREMITY (Pain in the legs), BACK PAIN (Pain in the lower back) and BEDRIDDEN (I was in bed) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 29-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEAD DISCOMFORT (felt pressure in the head), NODULE (nodules between throat and clavicle), PAIN IN EXTREMITY (Pain in the legs), BACK PAIN (Pain in the lower back), BEDRIDDEN (I was in bed), HEADACHE (Lot of headaches) and PYREXIA (Fever between 38.7 and 38.8 C). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of every 6-8 hours. At the time of the report, HEAD DISCOMFORT (felt pressure in the head), NODULE (nodules between throat and clavicle), PAIN IN EXTREMITY (Pain in the legs), BACK PAIN (Pain in the lower back), HEADACHE (Lot of headaches) and PYREXIA (Fever between 38.7 and 38.8 C) outcome was unknown and BEDRIDDEN (I was in bed) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) between 38.7 and 38.8 degree Celsius.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient received second dose on 26 SEP 2021.   This case was linked to MOD-2021-336063 (Patient Link).
I had become very lethargic and felt like I didn't have any energy. Had doctor's appt and a COVID test. I was feeling nauseous as well. I had headaches. I did a telehealth visit - MD-Live. The doctor (at Urgent Care clinic attached to my doctor's office) said to drink plenty of water. I was really sick.  - Flu vaccine was received three weeks before the date of this vaccine. 09/08/2021 - don't know the lot number
By night arm was achy and body aches started Thursday morning body aches all over and did not feel well, nausea. By 2:30pm felt cold, temp was about 100.8 degrees. Layed down to let it pass and couldn't move much. At night temp was 102.6 degrees F, took cold and flu pill since it has ibuprofen to see if it helped with fever. Friday was awake on and off, couldn't move much, temp at 12:30pm was about 103 degrees F. Called clinic but had long wait time. Called urgent care who recommended to go to ER. Went to ER, felt like health was going downhill. Blood work specified white blood cell count was elevated. At night blood pressure dropped, body was going into shock. Got lumbar puncture test because neck was too stiff. Moved to ICU on Saturday. They have performed cultures, CT scan of abdomen and head and all results negative. The doctors mentioned symptoms/reaction may have worsened because pt was dehydrated. Today still feels unsteady on feet and has headaches. Patient was moved from ICU to general bed and still in monitoring.
Heart beat went up; Pharmacist asked her if she was nervous or having anxiety and she said yes; Pharmacist asked her if she was nervous or having anxiety and she said yes; left arm sore; extremely dizzy; extremely weak; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: FA7485, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 59-year) in left arm on 16Aug2021 as dose 1, single for COVID-19 immunization. Medical history included allergy to penicillin, from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Time the vaccination was given: 1430- 1445. Prior vaccinations (within 4 weeks) were reported none. On 16Aug2021 the patient experienced extremely dizzy, extremely weak; on 17Aug2021 the patient experienced left arm sore; on an unspecified date the patient experienced heart beat went up, pharmacist asked her if she was nervous or having anxiety and she said yes. Adverse events not required to emergency room/physician office. The patient underwent lab tests and procedures on an unspecified date which included heart rate: heartbeat went up. It was reported that she was leery and nervous to get the second dose. It was reported that "she was calling about the Pfizer covid vaccine. She received it on Monday and immediately was extremely dizzy and weak. Heart beat went up and she told the pharmacist. Pharmacist asked her if she was nervous or having anxiety and she said yes. The pharmacist stated it could be since she was nervous and was told to sit as long as she needed. She felt like she could not get up and walk and got very weak. Her dizziness did not go away for almost an hour. With that kind of reaction, she was asking if she should she get the second dose. Advised to consult with hcp. The dizziness and weakness started within seconds of her receiving the vaccine, immediately. Her left arm was still a bit sore but that was expected, it was much better and sore if she pushed on her shoulder area. The soreness started yesterday. She got to the point when she was sitting in the pharmacy and then she got to where she could get up and walk to her car but did not drive right away. She sat in her car for a while since she did not feel comfortable driving since she was still dizzy. Clarified the really bad dizziness lasted for about an hour. Then about 2 to 3 hours later she was fine." The clinical outcome of the events "dizzy, extremely weak" was resolved on 16Aug2021; outcome of the event "left arm sore" was resolving; while the outcome of the other events was unknown.  Follow-up attempts are completed. No further information is expected.
Information has been received from the registered nurse concerning to an approximately 65 year old patient of unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 03-FEB-2015, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 (lot number: K005402 with unknown expiration date) (dose, route and frequency unspecified). Concomitant medications were not reported. No adverse event was reported. The outcome of the event was unknown. The causality of the events with PNEUMOVAX 23. This is one of the several reports from the same reporter. Additional information has been requested.
Fever of 99-100 degrees for 14 hours and counting, pain in lungs, coughing, severe chills 12 AM - 6 AM 10/31
Cough Itchy, watery sore eyes Sore throat Muscle ache Chills Headache In that order from 5:00pm until 5:00am, fine after 7:00am
receiving expired YF-VAX, with no reported adverse event; Initial information received on 22-Sep-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 3 patients of unknown age and unknown gender who was receiving expired YELLOW FEVER VACCINE - [YF-VAX], with no reported adverse event.  The patient's past medical history, medical treatment(s), Concomitant medication, vaccination(s) and family history were not provided.   Patients received the vaccine between 20-Sep-2022 and 21-Sep-2022, with an unknown dose of suspect YELLOW FEVER VACCINE - (strength, formulation was unknown,  lot UJ397AA and expiry date: 22-Sep-2022) via unknown route in unknown administration site for Immunization.  On 20-Sep-2022 and 21-Sep-2022 the patient developed a non-serious event of receiving expired yf-vax, with no reported adverse event (expired product administered) (latency: same day or 1 day) following the administration of YELLOW FEVER VACCINE - . Reporter was asking if the patients needed to be re-vaccinated and when they should be re-vaccinated.  Action taken : not applicable.  Outcome: Unknown  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 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.
Information has been received from a registered nurse (RN) concerning a female who was vaccinated with varicella virus vaccine live (Oka/Merck). In May 2007, after the booster dose of varicella virus vaccine live (Oka/Merck), the patient experienced a local injection site reaction described as a large hive at the site of injection. The patient was treated with benadryl and cortisone cream. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements for the Center for Biologics Evaluation and Research and was released. This is one of several reports received from the same source. Additional information has been requested.
Tingling and mild swelling of tongue; Tingling and mild swelling of tongue; This is a spontaneous report from a contactable other health-care professional (Patient). A 34-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: Er8730), via an unspecified route of administration, administered in right arm on 22Apr2021 at 09:45 hours as DOSE 1, SINGLE (at the age of 34-years-old) for COVID-19 immunization. The patient's medical history included systemic lupus, COVID-19 (COVID-19 prior to vaccination). The patient's concomitant medications were not reported. The patient had no known allergies. The patient took no other vaccine in four weeks  but took other medications in two weeks. The patient has not been tested for COVID post vaccination. On 22Apr2021 at 10:30 hours, the patient experienced tingling and mild swelling of tongue. The patient underwent lab tests and procedures which included COVID-19 test: positive on an unspecified date, COVID-19 prior to vaccination. The adverse event did not result in emergency room/doctor/physician/other health care office visit. The patient received no treatment for the adverse event. The clinical outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
03/30/2005- Was given DTaP, MMR, IPV in left thigh. Patient returned with mom on 04/01/2005 with c/o red, hot area on left thigh. Dr  says it is at injection site and thinks DTaP likely cause.
Fever 103 Diarrhea Clammy skin  Loss of appetite  Fatigue Crying at through the night (waking 4-5 times)  Rash began on face and spread to entire body
Body chills, aches started the night of the vaccine, then I ran a fever for starting at the 24 hour mark after the injection and it lasted about 6 hours.  I was able to reduce it by taking Tylenol and drinking fluids. Most symptoms cleared up after about 24 hours after they initially started. 36 hours later, I'm still a little tired, but not other side effects. This is my first pregnancy, with a due date of Oct. 8, 2021.