chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Deceased; This is a spontaneous report from a Pfizer. A non-contactable consumer reported that a patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Consumer reported that, "Amongst my coworkers about 50% were put down for two to three days and one person became deceased a few hours after the second shot." The patient died on an unspecified date. It was not reported if an autopsy was performed.   No follow up attempts are possible; Information on the lot/batch number cannot be obtained.; Reported Cause(s) of Death: Deceased
Patient here for flu shot at approximately 11:30 AM on 10/9/19. Around 2pm she started feeling short of breath, chest felt constricted. Went to E.R. Tongue felt slightly enlarged. CT chest done came back negative, having palpitations E.R. doctor determined not due to flu shot
Dark bruise at the inner part of my right thigh, near the groin, the size of three quarters (of Dollar), my right leg became weak, could not fold, have difficulty walking
Pt was an add on to a COVID vaccine clinic at  nursing home due to facility staff member not showing up.  Pharmacy technician that was at the clinic had pt fill out paperwork, and facility staff member administered Moderna vaccine in error to a 16 year old male.  Nursing home administrator is aware, and I have left a message for pts mother to call me back to verify if pt is having any side effects.  No treatment is recommended at this time.
Pt recvd 3 doses of Engerix-B 8NOV90, 30NOV90 & 1MAY91 & 12SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
Rx was processed for a 0.5mL dose however a 0.25mL dose was administered
(R) thigh at DTaP injection site - 2 in diameter red round area with lump underneath. skin warm to touch/tender. Tx Cefzil 125mg/5ml, 5ml PO BID x 10 days.
pt recv vax;during the last week of august1995, exp chafing under the arms and pain under the arms & in soft tissue;in april devel a stiff neck;tx w/ diclofenac sodium;sx persisted at time of report;
Patient received expired vaccine. DH and Pfizer recommended revaccination. Upon calling patient to reschedule, the patient stated he was ill post vaccination and was seen by his doctor. The doctor ran tests. The patient states he is fine now. He stated he was unsure if the reaction was caused by the vaccine.
nasal congestion, cough, exposure, headache, slight sore throat.  starting 1/13/22
lt upper outer arm @ inj site w/marked firmness & swelling; neg redness very tender instructed cold packs to lt arm;
Patient start bleeding alot after the injection and the injection site swelling up. Patient was given a dose of 50 mg of diphenhydramine then send to the Emergency right after. Patient denied taking any warfarin and asprin prior.
Case number PHEH2011US04010, is an initial spontaneous report received from a medical assistant on 12 Sep 2011: This report refers to 11-year-old female patient. She was administered MENVEO (batch number A100058), 0.5 ml, intramuscularly on 09 Sep 2011. After vaccination on an unspecified date, she developed redness and swelling at injection site which was notified on 12 Sep 2011. Events were ongoing at time of this report.
3:00am severe full body pain and cramping, high fever 6:00am nausea and vomiting, migraine, incoherent thoughts  Continued body pain, vomiting, fever for 24 hours
This report is regarding the Pfizer COVID-19 vaccination you received on the above date, which was lot number FD0809. The Public Health District, per guidance from the Department of Health, Centers for Disease Control and Prevention), and Pfizer have determined that the dose of vaccine that you received is valid.
I don't think I had an adverse event.  I had pneumonia 4 months after my vaccine, following a bad cold I got from my 2 and 4 year old grandsons.
Migraines with cyclic vomiting. Controlled with Excedrin and Phenergan. Daily from weeks 0-12 then taper off between weeks 12-24 then resolved after week 24
Information has been received from a pharmacist concerning an unspecified patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not informed. On 16-NOV-2016, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX 19400 PFU, (lot #, dosage and therapy route were not provided), expiration date 06-OCT-2016. Concomitant therapies were not informed. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
This spontaneous report was received from a pharmacist and refers a 53 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions and concomitant medication were not reported. It was stated that the pharmacy received the ZOSTAVAX on 15-JUL-2016. On 29-JAN-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX 19400 plaque-forming unit (PFU) injection, subcutaneously, 0.65 ml, lot # M014310, expiry date 26-MAY-2017 (anatomical location was not specified) for prophylaxis. On 22-MAR-2017, the pharmacy was audited by The Board of Pharmacy. The freezer temperature where ZOSTAVAX was stored was registered by the pharmacy thermometer as 2 Fahrenheit degrees, however the auditor's thermometer registered the temperature as 9 Fahrenheit degrees which was considered as a temperature excursion. The Board of Pharmacy auditor determined that the pharmacy's freezer thermometer should have been calibrated. Seven of the 10 doses of ZOSTAVAX that had undergone the temperature excursion had been administered to 7 patients between July 2016 and January 2017 (also reported as "over an 11 months period"). The remaining 3 doses were sent back for disposal. There was no previous temperature excursion. No adverse effect were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all follow up information has been received.; Sender's Comments: US-009507513-1705USA006382: US-009507513-1705USA006383: US-009507513-1705USA006384: US-009507513-1703USA010654: US-009507513-1705USA006380: US-009507513-1705USA006381:
Patient became syncopal approximately 2 minutes after vaccine.  Emergency services staff flagged down to assist patient.  The event I am recording this from states patient had "seizure activity", but given the short duration and quick resolution, suspect this was muscular activity and not neurologic.  Patient refused any sort of follow-up care afterwards.
low grade fever; body aches; fatigue; some nausea; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8733) via an unspecified route of administration in the right arm on 31Mar2021 at 11:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included gout. Concomitant medications included allopurinol (MANUFACTURER UNKNOWN) 300 mg daily from an unknown date and for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: En6199) via an unspecified route of administration in the right arm on 10Mar2021 at 11:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 01Apr2021 at 04:00, the patient experienced low grade fever for 2 days, body aches, fatigue and some nausea. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events low grade fever was resolved on 03Apr2021, while that of body aches, fatigue and nausea was resolved on an unspecified date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Day 6 I started having post menopausal vaginal bleeding; Day 4&5 I was exhausted; had stomach issues; menstrual cramps; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included High Blood Pressure, colitis, irritable bowel syndrome, penicillin allergy, and iodine allergy from an unknown date. Patient is not pregnant. No COVID prior vaccination and not tested for COVID post vaccination. Concomitant medication included losartan; metoprolol; and bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported. No other vaccinations in four weeks. The patient previously took sudafed [xylometazoline hydrochloride] and experienced allergies. On Mar2021 (reported as 19Mar2021 03:30 PM and 25Mar2021) patient had her first COVID-19 vaccine shot. First 3 days she felt fine. On unspecified dates in Mar2021, day 4 and 5 she was exhausted and had stomach issues, Day 6 she started having post-menopausal vaginal bleeding. It stopped on 27Mar then started again on 30Mar2021 to 04Apr2021 along with menstrual cramps. Patient commented that this might all sound normal except she has been post-menopausal for 15 years and she does not believe that is by coincidence. The patient underwent lab tests and procedures which included biopsy: unknown results on an unspecified date, ultrasound scan: unknown results on an unspecified date. Therapeutic measures were taken as a result of post-menopausal vaginal bleeding, was exhausted, had stomach issues, and menstrual cramps. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
9 APR 2005: 22 Y/O MALE PRESENTED TO URGENT CARE WITH CHEST PAIN, SUBSTERNAL WITH RADIATION TO EPIGASTRUM, AND ECG CHANGES SUGGESTING MYOCARDIAL ISCHEMIA, WITH A HISTORY OF RECEIVING THE SMALLPOX VACCINATION 8 DAYS PRIOR. ONSET OF CP WAS AT REST WATCHING TELEVISION. NO CARDIAC RISK FACTORS. DENIED EVER HAVING A SIMILAR PAIN IN THE PAST. EXERCISE TOLERANCE-ABLE TO JOG 20-30 MINUTES, 2-3 TIMES A WEEK WITHOUT ANY DIFFICULTY. NO INITIAL RESPONSE TO SUBLINGUAL NITRO OR BETA BLOCKER. HE RULED OUT BY ENZYMES AT ER, AND CP RESOLVED SPONTANEOUSLY OVER THE COURSE OF 3-4 HOURS. ECHO PERFORMED IN ER, NO ABNORMALITIES WERE NOTED BY THE OPERATOR.  11 APRIL 2005 F/U VISIT-NO FURTHER CHEST PAIN. ECG REPEATED AND NOTABLE FOR NON-SPECIFIC ST CHANGES. MILD TRANSAMINITIS PROMPTED ABDOMINAL ULTRASOUND, WHICH REVEALED MILD FATTY LIVER, OTHERWISE NORMAL (14 APRIL 2005).  21 APRIL 2005 A TREADMILL STRESS TEST WAS PERFORMED AT THE MEDICAL CENTER, WHICH REVEALED "SIGNIFICANT ST DEPRESSION IN LEADS II, III, AVF, V4-V6 (MAX 0.18mV)", PERFORM UP TO BRUCE PROTOCOL STAGE 3, FOR 8 MINUTES. A STRESS ECHO AND ANGIOGRAM WAS RECOMMENDED. 26 APRIL 2005 PATIENT FOLLOWED UP WITH TREADMILL RESULTS. STILL NO RECURRENCE OF CHEST PAIN. DAILY ASPIRIN WAS STARTED.  INCIDENTALLY, PATIENT ALSO BEGAN TREATMENT THIS DAY FOR AN ACUTE PHARYNGITIS (AZITHROMYCIN FOR PRESUMPTIVE GROUP A STREP), AND WE BEGAN A WORKUP FOR GROSS AND MICROSCOPIC HEMATURIA. 29 APR 2005 DECISION WAS MADE TO SEND THE PATIENT TO A HOSPITAL AT HOME. PAPERWORK WAS FILLED OUT AND SUBMITTED TO PATIENT ADMIN DEPARTMENT.  BETA BLOCKER WAS STARTED 28 APRIL 2005. IVP WAS SCHEDULED FOR 2MAY 2005 FOR HEMATURIA WORKUP. URI SYMPTOMS RESOLVED. 2MAY205 IVP PERFORMED, SUBSEQUENTLY READ AS NORMAL. UA REPEATED AND WAS COMPLETELY NORMAL. 10MAY2005 MILITARY AIR AVAILABLE WITH MEDICAL PERSONNEL ON-BOARD, PREPARATIONS BEING MADE TO SECURE TRAVEL ON THIS FLIGHT. 13MAY2005 DOCTOR'S  IMPRESSION/PLAN: SINGLE EPISODE OF CHEST PAIN IN THE SETTING OF SMALLPOX VACCINATION WITHOUT FURTHER RECURRENCE AND HAS GOOD EXERCISE TOLERANCE. SUSPECT UNCOMPLICATED POST-SMALLPOX PERICARDITIS W/O COMPLICATION (NOW RESOLVED) WHICH IN RESTROSPECTIVLEY I HAVE NO EKG, LAB OR PHYSICAL EXAMINATION EVIDENCE. HOWEVER, HE HAS NO SXS ON REPEAT ETT AD NORMAL ECHOCARDIOGRAM. PATIENT HAS LITTLE CARDIAC RISK FOR ASCAD AND NO FURTHER WORKUP IS NECESSARY. HE IS RELEASED TO FULL DUTY WITHOUT ANY PHYSICAL RESTRICTION.
One to two minutes after shot patient complained of seeing stars (light-headed) and felt nauseous.  Several minutes later the patient became unresponsive with eyes still open for around 2 minutes at which time EMS was called.  She was sweating profusely and had a week pulse.  The paramedics responded and checked her out.  They okayed her to leave with her husband after she was feeling better (15-20 minutes later) and there was NO transportation to the hospital needed.
No adverse reaction.  Tdap (BOOSTRIX) given instead of DTaP (INFANRIX).
Moderna x 3. Tested positive for COVID 19 on 02/01/2022. Admitted to Medical Center on 05/13/2022. Expired on 05/17/2022 while still hospitalized.
Rash at site of shot Fever Muscle pain at shot site  muscle and joint pain throughout body Tired/weak headache shivering due to fever fever No treatment yet. Waiting to see if symptoms lessen and disappear
Accidentally gave the Pfizer 6m-4yr bivalent instead of the Pfizer 6m-4yr primary series dose for the second dose. The vial was placed in the wrong location in the clinic and I didn't know it was the bivalent dose.  Child had no sx
Day of vaccine arm was extremely sore and felt overall tired as if I was coming down with something. After that was fine until day 10, woke up feeling short of breath and over all not well.  On day 16, began a racing heart. This has continued to current day. 3 ekgs normal, blood work done 4 times all normal, CBC, thyroid, metabolic panel, heart, etc. 3 chest X-rays normal, echocardiogram normal. But still short of breath and occasional racing heart that often wakes me from a deep sleep.
flu like aches; This case was reported by a consumer via call center representative and described the occurrence of flu-like aching in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced flu-like aching. On an unknown date, the outcome of the flu-like aching was recovered/resolved.   It was unknown if the reporter considered the flu-like aching to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix 3 or 4 months ago and had flu like aches for 2 days. The reporter did not consent to follow up. The reporter did not had any additional details regarding patient experience with Shingrix. This case linked with US2020208335, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020208335:same reporter
Fever, chills, bodyaches & shortness of breath - approx. 24 hours after receiving vaccine. Referred to ER for treatment.
Ocular herpes; blisters on eyelids; Inner lower eye lids with pain interior eye plus skin exterior in area; chills; fever; arm pain; rash on back; This serious case was reported by a consumer and described the occurrence of herpes ophthalmic in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 73XT7) for prophylaxis.   The patient's past medical history included herpes ophthalmic.   On 17-MAR-2023, the patient received Shingrix .5 ml. On 18-MAR-2023, 1 days after receiving Shingrix, the patient experienced herpes ophthalmic (Verbatim: Ocular herpes) (serious criteria GSK medically significant), blister (Verbatim: blisters on eyelids), eyelid pain (Verbatim: Inner lower eye lids with pain interior eye plus skin exterior in area), chills (Verbatim: chills), fever (Verbatim: fever), pain in arm (Verbatim: arm pain) and rash (Verbatim: rash on back). The patient was treated with fexofenadine hydrochloride (Allegra) and aciclovir (Acyclovir). The outcome of the herpes ophthalmic, blister, eyelid pain, chills, fever and pain in arm were not resolved and the outcome of the rash was resolved (duration 1 week).   It was unknown if the reporter considered the herpes ophthalmic, blister, eyelid pain, chills, fever, pain in arm and rash to be related to Shingrix.     It was unknown if the company considered the herpes ophthalmic, blister, eyelid pain, chills, fever, pain in arm and rash to be related to Shingrix.   Additional Information: GSK receipt date: 09-JUL-2023 It was reported that day after receiving Shingrix vaccine patient experienced fever, arm pain, chills day after, rash for 1 week on back, then blisters on eyelids, inner lower eye lids with pain interior eye plus skin exterior in area. Then went to left eye. The patient was treated with Allegra, Zyzal for allergy. The patient was treated with Acyclovir for Ocular herpes.
After the vaccination, the patient was directed to our waiting area and sat down in a waiting chair (which does have arms). After <5 minutes, patient passed out and fell face forward out of the chair onto the floor. She hit her head and was unconscious. We ran to assist her, after about 15 seconds she came to, but was in and out of consciousness. She developed a baseball sized hematoma on her forehead and was sweating profusely. We called 911 and got the AED machine. She then passed out again and threw up, so we placed her on her side. We monitored her closely and kept her conscious until the paramedics arrived. By the time they arrived, she did not have recollection of the event but was alert. They transported her to the hospital.
Patient presented to emergency department on 11/24/2021 following testing positive for COVID-19 two days prior. He reported shortness of breath and cough. He was started on supplemental oxygen, remdesivir, and dexamethasone. He was discharged home on 11/28/2021.
Psoriasis on gluteal areas that has been present for almost 2 months.  Lymph node on right neck area is swollen for almost 2 months.  Skin on chest, back, and stomach area is itching constantly.
Patient fainted approximately 3 to 5 mins after receiving the first dose. They were standing and fell to the ground during the 15 min mandatory observation period. EMS was called and checked his vitals. Patient refused to go to the ER. He was advised to continue to monitor his symptoms and call EMS or his doctor immediately if symptoms worsen. Patient advised to download mobile CDC reporting app. EMS checked his vitals and all were normal.
We were contacted by  Improvement Registry and told to report this incidence to you. The mother of the above patient lied her date of birth so she could get Covid vaccines.  No insurance was given to us so we ran our special way to run the vaccines. We had no idea that this patient was only 9 years old.   By the way, the patient/her mother hasn't reported any adverse events.
Received Dtap, PREVANAR and MMR in office on 06/27/06. Developed fever to 100.5 and fussiness that day and next. Also developed minor rash 6/28/06. On evening of 6/29/06 had apparent seizure w/apnea, cyanosis and fell down. Some shaking of upper extremities. recovered after a brief period. Then had another episode and recovered.
PT REPORTED TO MEDICAL CENTER ON 16 MAR 2008 FOR PAIN AND SWELLING AT THE INJECTION SIGHT.  PT STATES THAT MC GAVE HIM MOTRIN FOR PAIN.  PT REPORTED TO ISC FOR EVALUATION ON 17 MAR 2008 WITH IMPROVED SX'S SINCE STARTING THE MOTRIN WITH LESS EDEMA AND ERYTHEMA.
Horrible migraine 5/30-6/4 went to PCP to get a migraine shot because my migraine breakthrough medicines would not work.Strep throat on 6/11/21 and then my back went out -I was in ER 7/2/21  i couldnt walk or move without crying out in pain.I could not move my legs. Released from theER when I could stand up even though I was still in excruciating pain. I was given a cocktail of muscle relaxer, anti-inflammatory, nausea& 4mg of morphine. I could still feel the pain.Finished the prednisone 7/6 went to a dr at my PC office prescribed me tizanidine 4mg 3x a day, but it isnt helping. Can barely walk, cant drive,I cant turn in bed to roll to my other side. Once I get in one spot I have to stay to stay there.
vaccine was administered after experiencing temperature excursion/Temperature -11.6C during 30 minutes; No additional adverse event details; This spontaneous report was received from other unspecified reporter concerning to an approximately 1 year old patient of unknown gender and race. The patient's medical history, historical drugs, known allergies, concurrent conditions, and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX), with lot number U02505 (expiration date: 13-AUG-2023) that was an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX) administered for prophylaxis (dose, frequency, strength and route of administration were not provided) that underwent through a temperature excursion of about -11.6 degrees Celsius (C) during 30 minutes (Product storage error). No further information was provided.
Felt nauseous  3/12-3/15, feeling exhausted March 16 and 17, this morning several bouts of diarrhea ( and last night as well) and I am dehydrated
I experienced dizziness right after I received my first vaccination of the Moderna shot, but was ok after sitting down for a few minutes. On 2/27/21, I woke up with dizziness, which has continued since.
Discomfort and slight pinkness at inj site day after flu shot area warm to touch. Has tennis ball sized lump at site of inj.
This is a spontaneous report received from a contactable reporter (consumer or other non-healthcare professional). The reporter is the patient. A 95-year-old female patient received bnt162b2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, solution for injection), administration date 18Feb2021 (Lot number: EL9266) at the age of 95 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (lot number: EN9581, dose 1, single), administration date: 28Jan2021, when the patient was 95 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "My arm is still hurting so bad"; SENSORY LOSS (non-serious), outcome "unknown", described as "I lost complete feeling in my hand. I could not pick up anything"; BODY TEMPERATURE ABNORMAL (non-serious), outcome "unknown", described as "It (temperature) has been running 94.0 every day, until today it rose to 97.0". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, sensory loss, body temperature abnormal. Additional information: It was reported that the treatment received was Aspirin and patient stated that she was perfectly healthy and takes regular medications that the doctor gave. No follow-up attempts are possible. No further information is expected.