chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe diffuse abdominal pain awakened from sleep at night; Severe diffuse abdominal pain awakened from sleep at night; This is a spontaneous report from a contactable nurse (patient). A 63-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration in the left arm on 06Jan2021 14:00 at a single dose for COVID-19 immunization at the hospital. Medical history included high blood pressure and allergies to penicillin. Concomitant medication included losartan. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe diffuse abdominal pain awakened from sleep at night on 07Jan2021 01:00 AM. The patient took Tylenol. The events lasted 2 hours from 1am-3am. Outcome of events was recovered on 07Jan2021 03:00 AM. The events were assessed as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
ACHY JOINTS; HEADACHE; TIRED; This spontaneous report received from a patient concerned a 44 year old female. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced achy joints, headache, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the achy joints, headache and tired was not reported. This report was non-serious.
acute cerebellar ataxia; Annual follow-up received on 10/19/00 provided no additional data.
Frequent headaches were coming on and off for about 2 weeks. The I experienced a PE and superficial blood clot of left arm developed while I was sleeping,  it waked me in pain and I called a nurse hotline. The nurse advised me to go to the hospital.
Hives all over entire body and he started wheezing. He immediately developed breathing problems and has continuously gotten hives all over his body since.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 56-year-old female patient who received SHINGRIX (batch number ZG47A, expiry date 12th February 2021) for prophylaxis. On 14th August 2018, the patient received SHINGRIX. On 14th August 2018, several hours after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were reported as follows: This case was previously reported to a physician. The patient received SHINGRIX on the left arm. The patient experienced redness at the injection site which was about the size of a quarter. The symptoms began after a few hours of receiving SHINGRIX vaccine. This case was one of the 3 cases, reported by the same reporter.
Hives occurring the next morning. Tx: Benadryl Q6hr prn. Was seen 11/3/08 hives were resolved by next day.
Rash with red lumps.  First appeared on arms! Then included back , the a few days later, upper chest.  Lumps were very itchy.  Put anti itch ointment on rash areas.  Condition did not improve.  Sought medical help.  Dr. Prescribed Prednesone and Claritin generic pills.  Itching de teased significantly.  Rash and bumps are still visible, but appears to be healing.  Course of medication is continuing.  Itching has mostly subsided.
This spontaneous report as received from a physician and refers to an unspecified number of patients of unknown age and gender. Medical history and concomitant medications were unknown. It was reported that improperly stored dose of PNEUMOVAX 23 (single dose vials) lot # L013428, expiration date 03-FEB-2017, (dose and route were not reported), was given to unspecified patients on unspecified dates. No adverse effects were reported. It was unknown if the patients sought medical attention. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Bruising at injection sight,  pain in left arm running from shoulder running down arm (could not lift arm due to pain), extreme fatigue,  fever of 100.7, loss of appetite, dizziness
After receiving both vaccines pt went to her car in the parking lot felt nauseated. Mom returned to the office, pt. pale (diaphoresis) alert and oriented. Pulse 76 and thready, given juice-observed for 15 mins-color returned to face and discharged.
Woke up next morning with red hives on her neck and face. She used BENADRYL and it seemed to help.
Nausea, dizziness, light-headed 23MAR-28MAR; pt seen in ER 28MAR given Antivert;
2 days past vaccination shoulder pain started. Pain is burning and sharp in nature and radiate from the top of the shoulder to occasionally near the back shoulder blade. Range of motion is affected as it is painful to reach backwards or straight out laterally. Taking 800 mg of Ibuprofen every 6-8 hours to help ease burning sensation. Not always completely helps.
A report has been received from a Pharmacist concerning a 52 year old, Male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST started on 03-Jan-2014. The reporter mentioned that FLUMIST was inadvertently administered to a 52 year old patient which started on 03-Jan-2014. The outcome of the event of administration to a 52 year old patient is unknown. The report was considered to be non-serious.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 06Apr2021 as dose 2, single (Lot number: ER8737), in left arm and on 16Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: known allergies Sulfa. Concomitant medication(s) included: TYLENOL, start date: 03May2022, stop date: 10May2022, other medication in 2weeks product. Past drug history included: Omnicef, reaction(s): "Known allergies: Omnicef". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of suspected Covid-19 included Paxlovid, treatment start date=07May2022, treatment stop date=12May2022. Clinical course: -Taste of bile present beginning 12 hours after first dose and lasting until course completed. Increased alertness. COVID 19 symptoms, including sore throat, cough, congestion, difficulty breathing and headache reappeared 5 days after the final dose of Paxlovid. The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.
53 year old female patient developed Shingles three weeks after 2nd dose of Pfizer COVID19 vaccination.   January 2021: Prior COVID19 illness. September 4, 2021: 1st COVID19 vaccine administered. September 25, 2021: 2nd COVID19 vaccine administered. Patient experienced pain in her back (left side of spine only) for 2 days, followed by burning sensation in same area, followed by rash consistent with Shingles in mid-backside left side only, extending laterally towards abdomen.  Patient had chicken pox as a child in the early 1970's. Patient also had a serious COVID19 illness in January 2021, although she was not hospitalized. Patient began treatment with Valacyclovir HCL 1 gram TID within 48 hours of developing Shingles.
patient called back one hour after vaccine administration.  C/O arm tingling, burning pain, "nerve pain."  I instructed her to go to urgent care/ER for eval and she declined due to having no insurance.  I informed our medical staff of the issue and her psychiatriast followed up with her.  She took some pain meds and is feeling better and knows to go to ER if symptoms dont resolve or get worse.
8/7/21: weakness, shortness of breath, chest pain, headache, muscle pain, headache, nausea, chills- sent to the ED by PCP, ECG and labs completed, discharged to home 8/9/21: weakness, feeling faint, short of breath, chest pain, diaphoresis, nerve pain, headache-sent to the ED by PCP, ECG/labs/IV Fluid, discharged to home 8/10: muscle pain, tingling through body, weakness, fatigue 8/17: headaches, muscle pain, nerve pain, weakness, nausea,  feeling faint 8/21: tachycardia, feeling faint, not sweating in the heat, nausea 8/30: tingling, nerve pain, headache, nerve pain in neck, chest and arms- ED visit, EKG and Mg, CBC, CMP, Troponin, CXR, EGRF,  9/2: seen by cardiology for feeling faint, tachycardia at times, chest pain, fatigue, CRP/SED Rate, increase sodium, apply compression socks out of work 8-10-8/16 and 8/23-9/7
This spontaneous report as received from an office manager refers to a 72 year old female patient. None medical history, concurrent conditions, known drug reactions/allergies and concomitant therapies were reported. On 16-JAN-2017, over the age of 65 years, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # M036728, expiration date 20-MAY-2018, intramuscularly; dose was not reported) for prophylaxis. On 17-JAN-2017, the patient experienced a fever and redness and tenderness at the injection site. The patient sought medical attention via calling the physician's office and the physician prescribed ADVIL and ice. None lab diagnostics studies were performed. The outcome of the adverse events was reported as not recovered. The relatedness between the adverse events and PNEUMOVAX 23 was not provided. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments:  US-009507513-1701USA007767.
Moderna dose was drawn up and administered  after recommended 12 hour punctured Beyond Use Date (BUD) but before recommended 24 hour room temperature unpunctured BUD.
Information has been received from an office manager in a physician's office concerning a patient who was vaccinated with a single subcutaneous dose of Varivax in error instead of Zostavax. No product quality complaint was involved. Additional information has been requested.
This spontaneous report as received from a nurse refers to a 12 years old female patient. No concurrent condition, medical history, or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, lot # K005881, exp. date: 14-JAN-2017 (dose, strength unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
entire body shaking, verbal complaints of nausea and wanting to throw up -- did not, verbal complaints of being very hot. Skin cold and clammy. At onset stated chest hurt but then denied. touching throat area stating "it's all right here." States has had panic attacks in the past "but not like this." Able to respond verbally to verbal stim.
Patients report after receiving the vaccine.   "Starting around 10pm started not feeling well, felt feverish.  By 2am started vommiting, nausea, headache.  Body feels achey and burning.  Had a fever of ~102.  After a couple of hours I was able to fall asleep.  Had a fever throughout the day Tuesday but took Tylenol.  I don't have a fever today.  Since then I have felt tired and have occasional nausea and headache.  Haven't been able to eat yet."  "I woke up at 10:30am today, I'm feeling better than I was yesterday but still can't eat"  Describe Treatment/Outcome (See next page) Patient recieved their first 2 COVID-19 Vaccines 2/3/21 and 2/24/21.  Patient came for their 3rd/Booster shot on 10/4/21 at the senior housing where they live.  When the pharmacist went to inject the patient they pulled their arm away and stated that it felt like it hit a nerve.  When injecting the first shot since the patient pulled their arm away no vaccine was injected into the patient.  The pharmacist retrieved a new syringe and proceeded to inject the patient without incident.  The following day the patient's daughter contacted the pharmacy concerned that her moster was very sick.  She was concerned about getting the extra dose.  Pharmacist called the patient and their statement is in the information above.  Patient said they didn't feel well when they got their second shot.  Patient thought they were getting better and haven't looked for any additional care. Daughter wanted to make sure a report was made.  We assured her we will fill out a VAERS report and we gave her information about V-Safe to also self-report any additional side effects or symptoms.  Patient was told to keep an eye out for high fever or worsening symptoms and to call the PCP if anything progresses.  We will follow up with the patient again tomorrow (10/7).
extreme anxiety; neuro inflammation; headaches; vertigo; central nervous system was so irritated/Central nervous system irritation; This is spontaneous report received from a contactable nurse (parent). This nurse reported same events for herself and 2 patients (twin sister and daughter). This is a second of three reports.   A female patient (reporter's daughter) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient experienced neuro inflammation, central nervous system was so irritated/central nervous system irritation, headaches, vertigo, and extreme anxiety ever since. Events resulted in disability or permanent damage. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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,Linked Report(s) : US-PFIZER INC-202100911195 Same reporter/ drug/ AE, different patient.;US-PFIZER INC-202100911266 Same reporter/ drug/ AE, different patient.
Patient has red, firm lump on (L) thigh at site of varicella vaccine. Given on 9-14-11.
Fever 100, injection site moderate pain, chills, moderate malaise, inability to sleep through night
4pm - pain at injection site, 7pm - upset stomach, chills start 11pm - chills, headache, neck ache, can?t relax/sleep for several hours Overnight - strange dreams, wake up often 8am+ - awake for awhile but headache worse especially when stood up, fell asleep until noon - headache has largely dissipated, injection site on,y hurts when touched,  stomach feels mostly normal
Information has been received from a consumer concerning her daughter who on unspecified date was vaccinated with GARDASIL vaccine (yeast) (lot# unspecified). It was reported that on unspecified date the patient developed rash. At the time of this report the outcome was unknown. No other information is available. Additional information is not expected.
Passed away/Hemorrhagic shock acute blood loss ruptured abdominal aortic aneurysm; Passed away/Hemorrhagic shock acute blood loss ruptured abdominal aortic aneurysm; Shingles; This is a spontaneous report received from a contactable consumer or other non hcp (patient's child). A 67-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: ER8731) via an unspecified route of administration in arm (arm shoulder) on 18Apr2021 (age at vaccination 67years old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had the test (before vaccination) where they put dye in the bloodstream and where they check for any "insularism" (presented as reported until clarified) or anything he had that process done, may be in March (result: not reported). There was no other prior vaccination. On 20Apr2021, the patient had shingles. He broke out to shingles 2 days after receiving the Pfizer Covid-19 vaccine, reported the shingles broke out. The patient went to the Doctor and they gave him some medicine (unspecified medication) for his pain (onset date: 2021). Therapeutic measures were taken as a result of shingles. In May2021 (one month to the date he got his vaccine exactly), the patient went into the hospital (as per death record but the patient told reporter that 2 days after getting the vaccine, he broke out shingles and when he called, they gave him a confirmation). The patient had hemorrhagic shock acute blood loss ruptured abdominal aortic aneurysm on an unspecified date and patient passed away (as per death record). The reporter stated that patient had passed away and reporter believed it was due to the Pfizer BioNTech Covid-19 Vaccine. The clinical outcome of the events shingles was unknown. The patient died on 20May2021. Autopsy was performed with results not reported.   Follow-Up 07Jul2021: Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: hemorrhagic shock acute blood loss; Acute blood loss ruptured abdominal aortic aneurysm
The patient was given the 2 vaccines in the same arm. She stated that a couple of hours after getting them she noticed a couple of red spots on her upper arm. The day after she received the vaccine the patient said she had much more redness that was below the red spots and extended a couple of inches to right above her elbow. When she presented to the pharmacy the second day after getting the vaccine, she stated that this spot was warm and her arm was stiff. I instructed the patient to take benedryl and prednisone she had at home. I also advised her to use cold compresses.
This spontaneous report as received from a registered nurse via company representative refers to a 6 days old neonate patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 12-SEP-2016, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB (lot number: K010216, dose, frequency, expiry date were not reported) for prophylaxis. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter source. Additional information has been requested.; Sender's Comments: US-009507513-1612USA003706:
Headache, body aches, fatigue, sharp pain in joints (elbows and knees), chills and shortness ofbreath
full body rash from the neck down; itchy and burned like crazy; burned like crazy; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 54-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 10Apr2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported as rash after first dose and the patient received the first dose of the Pfizer Covid-19 vaccine on 10Apr2021, in which he reports everything went fine. On 21Apr2021, he broke out in a full body rash from the neck down, which was described as "itchy and burned like crazy." He states he took Benadryl for a few days, in which the pruritus went away, but the rash remained present. He states that he went to a dermatologist and internist, in which he was prescribed to take prednisone for 6 or 7 days, and the prednisone made the rash go away. He states he was scheduled for his second dose this past Saturday, in which the internist advised him to hold off since they were not 100 % sure if he should receive the second dose. He states he researched pictures online that presented rashes, and states his rash looked like the pictures, only more intense. He is asking if he should receive the second dose or not. He wanted to know what the efficacy after one dose is and asked how long he can wait to take the second dose. Therapeutic measures were taken as a result of all the events. The outcome of the events was recovering.
Discharge Provider: MD Primary Care Provider:  DO Admission Date: 2/7/2023 Discharge Date: 2/20/2023  PRESENTING PROBLEM: Weakness [R53.1] Generalized weakness [R53.1] Fall, initial encounter [W19.XXXA] Respiratory tract infection due to COVID-19 virus [U07.1, J98.8] Acute respiratory failure with hypoxia (HCC) [J96.01]   HOSPITAL COURSE: Patient is a 77-year-old man with past medical history significant for obesity, non-insulin-dependent diabetes mellitus who presented to ED for generalized weakness and failure to thrive 2/2 to COVID 19. In the emergency department patient's vitals and labs hemodynamically stable.  He was not hypoxic and had normal chest x-ray.  He was severely weak so was admitted to internal medicine service for PT/OT and likely placement.    During hospitalization he did develop hypoxia at one point briefly requiring high-flow nasal cannula.  He was placed on remdesivir and Decadron.  He was quickly weaned back to room air. However again had worsening respiratory status on 2/15. CXR at that time showed worsening RLL infiltrate.  He was seen by SLP w/ concern for aspiration. He had VFSS which did showed low risk for aspiration.    Pt was noted to have waxing and waning mental status. Per wife he has had worsening memory otpt, no longer handles medication or finances. Pt was advised to follow up with neuropsych as an outpatient.   Of note while on steroids he did have uncontrolled hyperglycemia and was placed on basal bolus insulin. Was consulted and they managed insulin therapy while inpatient. Advised that patient patient should increase metformin to 1000mg twice daily at discharge as well as corrective Humalog insulin.   COVID-19 symptoms did improve however remains severely weak.  PT/OT did recommend SAR.    Patient discharged to SAR in stable condition on 2/20/2023
patient was given wrong vaccine by mistake, np which ordered vaccine stated it was harmless and the pt will be fine.
Severe teeth and gum pain with terrible pain throbbing left side of my face only. Could not drink anything especially anything cold felt like all my gums and teeth were like raw nerves that were exposed, even breathing in air was painful.  The pain started to subside around 7am .   I actually went to a dentist at 9 am the next morning after being up all night she did an x-ray just to make sure there was anything infection etc all but all was perfectly normal.  She suggested I email the CDC with what happened to me.