chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen at Vaccine site, red, hot to the touch, painful to lift arm, and itchy.
day 1-3 lethargy, day 2-4 L arm injection site swelling and itching Narrative:
Patient had swelling of lip and tongue, followed by shortness of breath/difficulty breathing for about 10 minutes,  diphenhydramine liquid and 1 dose of epinephrine autoinjector administered, EMS called and assessed patient, no transport to hospital, patient was able to leave on her own at about 9:00am
Per patient, at approximately 2pm patient received first pfizer vaccine for covid EN608 EXP 6/30/21 in her left deltoid muscle. Approximately, 10 mins. later patient c/o "tingling of lips and tip of tongue". Per patient use to have a "book" of numerous allergies, unable to recall all allergies this day. Stated she has "environmental and cat dander allergies". C/O of history of anxiety. Offered patient to send to hospital via ems for evaluation and higher level of care and refused. Patient signed refusal and it was witnessed. After symptoms resolved 30-45mins in EMS area, patient left in stable condition. This provider instructed patient to call her primary and obtain a clearance from primary to obtain send dose of covid vaccine in 3 weeks. Patient verbalized understanding.
This case was reported by a consumer via call center representative and described the occurrence of meniere's disease aggravated in a female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included meniere's disease (The patient had a medical history of meniere's disease which has been in remission for 2 years). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced meniere's disease aggravated (serious criteria GSK medically significant) and dizzy spells. On an unknown date, the outcome of the meniere's disease aggravated and dizzy spells were unknown.  It was unknown if the reporter considered the meniere's disease aggravated and dizzy spells to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. fter her first injection, she had her first bout of dizziness from meniere's disease.  The patient would call back if has additional information to provide. This was all the patient wanted to share at this time. It was okay to contact patient back regarding this report. This case has been linked with case US2019018258, reported by same reporter for same patient.
Approximately 45 mins after the vaccines were administered my daughter told me that her hands itched very badly. Then a few minutes after that she started itching her head. She then started to break out in a bright red rash all over her back that then spread to her neck and chest. A few minutes after the rash hives appeared. They were all over her back, neck and face. Her ears were then so red they almost looked purple and itches her tremendous. She then started coughing and her voice went hoarse and told me she was having a hard time breathing. I immediately rushed her to the ER (thankfully it was only 2 minutes away) where they brought me back immediately as they could see she was in distress. The Doctor immediately administered epinephrine as she could see she was having an anaphylactic reaction. Benadryl and prednisone was also administered. We were sent home with an epi pen and prednisone for 5 days. We were told to follow up with an allergist. We are going on 9/11/2018 for allergy testing.
Fever, severe headache, flu type body aches, extreme fatigue, chills and stiff joints
w/in 4 hrs of inject @ 1/2 strength (had similar rxn on prev inject) entire thigh swelled, became erythematous, had high fever & extreme irritability;
Pfizer Dose 1 3/25/21 (EN6204) Pfizer Dose 2 4/22/21 (EW0151) COVID Positive 7/26/21  7/26/21: Presented to ED. Patient is 77-year-old lady with known history of COPD.  She has been having cough and worsening shortness of breath for 6 days.  She was seen in emergency department on 7/23/2021 and was discharged to home on Azithromycin.  She continued to have worsening cough and shortness of breath.  Sometimes brings out small amount of sputum.  Dyspnea is worse on exertion.  Feels better when she sits.  No history of recent weight gain or weight loss.  History of exposure to  SARS-CoV-2.  She denied fevers, chills, nausea, diarrhea, loss of taste or hemoptysis.  7/28/21: She is a 77-year-old female with a history of COPD not on home O2 and she initially presented to the emergency room on 07/23/2021 complaining of worsening shortness of breath of 6 day duration was prescribed azithromycin and subsequently discharged.  However she came back on 07/26/2021 with more SOB.  At the emergency room the O2 saturation was 86% on room chest x-ray showed some infiltrate in the left lower lobe.  The ABG was significant for a pH of 7.30 and a pCO2 69.  The COVID-19 screen was positive of note is that this patient has already received 2 doses of COVID-19 vaccination.  Chest x-ray showed no acute cardiopulmonary findings.  Patient was diagnosed with acute hypoxic, hypercapnic respiratory failure likely due to a combination of COVID-19 infection and COPD exacerbation.  She was admitted to hospital and commenced on IV remdesivir, IV antibiotics Rocephin and azithromycin, bronchodilators, IV steroid and in addition to supportive therapy.  She was briefly on a L of oxygen but was later discontinued.  Patient has been improving since admission. On re-evaluation this morning the O2 saturation is 94% on room.  She voiced no complain and stated she is breathing perfectly fine.  She had oxygen walk for home determination and the result....  She will be discharged home on antibiotics-Ceftin and azithromycin and tapering dose of prednisone.  I advised her to follow up with PCP in 1-2 weeks.  I further advised are not to hesitate to come back to the emergency room if her breathing gets worse.
VACCINE ADMINISTERED TO A 14 YEAR OLD PATIENT; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 14 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: UNKNOWN) dose was not reported, administered on 23-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-JUN-2021, the subject experienced vaccine administered to a 14 year old subject. On 23-JUN-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered to a 14 year old patient and off label use was not reported. This report was non-serious.
I had swelling in my eyes within the hour. It was enough to distort my vision. Later that night I had trouble breathing so I took Claritin. The next morning I woke up at 7:00 am with hives all over my arms and chest. They lasted for about a week.
Redness/warmth at injection site-> approx 12cm. No pain/tenderness (+) itchy - also noted small abrasion in area. Cephalexin 250 mg TID x 7 days, BENADRYL PRN itch warm/cold compresses.
After administration of vaccine patient experienced syncopy BP 98/50 waited 15 minutes rechecked BP 92/60.
This spontaneous report was received from a Registered Nurse concerning an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L040054, the expiration date: 26-DEC-2017 and lot# M031557, the expiration date: 07-APR-2019 (dose and route were not provided) for prophylaxis.  No adverse effects reported nor Product Quality Complaint involved (PQC). The call was made due to data logger with a temperature of 35°F during 45 minutes. There was no previous temperature excursion reported.     This is one of several reports received from the same reporter.    Additional information is not expected because the reporter refused additional contact.; Sender's Comments: US-009507513-1704USA001678: US-009507513-1704USA001679: US-009507513-1704USA001680:
Several hours after receiving H1N1 vaccine, infant had temp to 102 degrees F. Crying, fussy, poor sleep, poor appetite over next 2 days. When came in my office on 11/6-had bumps on feet, hands and back of throat. Consistent with a Coxsackie-like illness.
Did not feel well; pneumonia; Covid-19; trouble breathing well; a little tired for a couple of days; A spontaneous report received from a Consumer concerning, a 67-year-old age female patient who received first dose of the Moderna COVID-19 vaccine and developed a serious, medically important event of pneumonia, in addition to non-serious events of COVID positive test, dyspnoe (reported as trouble breathing) and malaise (reported as do not feel well).  The patient's medical history included cancer, cough and fatigue. Patient's concomitant included Ibrance, Levofloxacin and Dexamethasone.   On 01 FEB 2021 date, the patient received their first dose of the two planned doses of mRNA-1273 in unknown arm (Batch #: 043L20A or 043620A) intramuscularly for prophylaxis of COVID-19 infection.   Patient stated that she had a cough before receiving the vaccine which can be caused by cancer medication that she takes. She reported that she was also a little tired for a couple of days. Patient stated a week later on 10 FEB 2021, she saw her oncologist and let them know that she had trouble breathing well and did not feel well since the day before. Patient stated she was informed by the nurse that it's probably just a reaction to the vaccine. She stated she received her regular cancer treatment that day. Patient stated the following week on Tuesday 16 FEB 2021 she had trouble breathing and saw her primary doctor who diagnosed her with pneumonia and prescribed levofloxacin for 10 days and dexamethasone twice daily 7 days. She was also tested for COVID which came back positive. Patient provided consent to follow up with her.  Treatment medication was prescribed by primary doctor (Levofloxacin and Dexamethasone).  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
This spontaneous report as received from a physician refers to unspecified number of patients of unknown demographics. On an unknown date, an unspecified number of patients may have received ROTATEQ 0.5 milliliters suspension, orally (lot # J004875, expiry date: 17-OCT-2014). The reporter reported that ROTATEQ were exposed to a lowest temperature of 32F (Farenheit) for a total of 1 hour over "four different occasions" and the improperly stored ROTATEQ were administered orally to an unspecified amount of patients. No adverse effect was reported. there was no product quality complaint involved.   This case is linked to 1405USA004025, 1405USA011937, 1405USA011938, 1405USA009508, 1405USA011939, 1406USA009955, 1406USA009970, 1406USA009972, 1406USA009973, 1406USA009974, 1406USA009977 and 1406USA009978 (same reporter link). Additional information has been requested.
States this morning she started itching on face, right forearm and back and had rash at those areas, 110 mm by 45 mm reddened area left deltoid area at injection site.
Patient received the vaccine on 11/8 and presented to emergency department on 11/11 due to severe headaches. This patient has a history of breast cancer with metastases to the brain and had recently underwent a lumbar puncture on 11/8 as well. Headaches were thought to be primarily due to the lumbar puncture or cancer, but booster dose may have also played a role. Patient was evaluated by pain management and discharged the same day.
has body aches; shivering; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st March 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 2nd March 2021, 1 days after receiving Shingrix, the patient experienced general body pain and shivering. On an unknown date, the outcome of the general body pain and shivering were not recovered/not resolved.   It was unknown if the reporter considered the general body pain and shivering to be related to Shingrix.  Additional details were provided as follows: The patient received shingrix and next day morning experienced body ache and shivering. The events were not resolved. The patient consented to follow up. There was discrepancy in the reported event onset date of body aches. It is 1st Mar 2021 but as per narrative it is captured as 2nd Mar 2021
She got her vaccine, the site of the injection hurt.  After that it started to swell a little.  Then she just started to feel not good, not bad, but just achy, which went through the night.  Her left arm site hurt.  She went about her day the next day, still achy, feeling a little off.  Her notice started to drip like she had a cold, nothing major.  That evening the pain started to get worse, and then it moved to her right side was the one that took a real hit, which was her shoulder and arm and underneath.  She cannot lift her right arm.  She went to UC on Wednesday, yesterday and was in the ER today.  They did not do any x-rays or CT scans.  One of the doctors told her that it could be an AE to the medication. They told her that she may have rhabdo, and gave her IV fluids, and today she was told that it could be tendinitis, inflammation of the arm.  On Wednesday she had been taking Motrin and aspirin that she alterated, as well as ice.  Yesterday when she went to the UC she was given IV, and IV Toradol and continued to do the ice, Motrin and aspirin.  She went back today as she was still having problems, and then the ER doctor presdribed some Medrol dose pack, and to take increased amounts of Motrin and was taking 3 of them.  It has taken the edge off, still cannot lift her arm as she was just in pain prior to this.  She can't take the Motrin once she starts the steroids.  She is planning on started the steroid dose pack in the morning.  He also prescribed a Lidocaine patch and muscle relaxer Cyclobenzaprine Hydrochloride 5 mg, which she has not taken yet as she has issues with medicines making her drowsy.
Pt c/o a "migraine" like headache in frontal region.  BP 178/118 P 78.    Pt commented after getting her 1st covid vaccine- she was very tired, nauseated, bad headache & labored breathing.  Had to sleep sitting up & missed a couple days of work.  4:25 PM 163/122 P86 4:55PM BP 161/119 P 80 R 16  Pt feeling better & leaves without assistance.  Instructed to call her PMD about her BP issues & use her inhaler at home.
patient had a severe shoot up in her blood pressure.  Called 911 and was transported to a hospital.
Grand mal sz lasting 15-20min-was not preceded by fever or other sx;Given APAP for temp elevation; irritable, crying, became limp & started jerking all extremities w/eyes staring straight ahead looked pale;
Stomach cramping, mild flu symptoms onset 7 hours after vax. 31 hours after vax extreme stomach cramping and pain. Went to ER. CAT scan indicated appendicitis.  Appendix removed 53 hours after vax. Perforation of appendix noted.  Treated with IV antibiotics for 2 days post surgery.  Oral antibiotics for additional 7 days.
Urticaria at injection site within two minutes, received po benadryl.  No wheezing, no hypotension, no other rash noted.  Patient's symptoms began to abate within one hour
Heavier than normal longer menstrual period with severe pain cramps. The night of first dose pain stiffness trouble walking next a fever 2 Days Later rash on my arm lasted 1 month. The site of the vaccine was swollen the size of baseball for 2 weeks. severe cramping like a menstrual period. After second dose period started early on the day of the vaccine 3/28/2021 with severe and heavy long menstrual period. Next month of April menstrual period late 4 days longer and heavier several pain. On 05/05/2021 ovulating with severe cramps pain.
died two weeks ago after his 2nd dose; This is a spontaneous report from a non-contactable consumer. A male patient of unspecified age received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single dose for COVID-19 Immunization. Medical history and concomitant medications were unknown. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 Immunization. The reporter knew their personal situation where a man died two weeks ago after his 2nd dose so, the reporter was horrified that they will not considered the safety of the public before taking that emergency FDA approval because they know that it took more than just a minute of the time to determine the safety and the reporter would hope that have the integrity too consider that over the money at this point in time. When probed if the concern is with Pfizer COVID-19 vaccine, reporter stated, "Yes of course." It was unknown if autopsy was performed. Outcome of the event was fatal.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: died two weeks ago after his 2nd dose
Pt recvd 2 doses of vax & sometime p/the 2nd dose exp elevated liver function tests;
pt recvd MMR vax on 29JUL91 & devel a rash on 9AUG91; no further details were provided;
Patient experienced itching in the arm, armpit then into the chest. Patient felt hot and dizzy. Clinic staff administered diphenhydramine and recorded a high blood pressure reading. Patient was transferred to the Emergency Department where she was monitored. Itching and rash spread to neck and back of the head. Patient was administered steroid treatment and given an outpatient prescription for the following four days for treatment.
Pfizer Bivalent vaccine was administered instead of second dose Pfizer Monovalent Patient contacted and was informed. No harm was accrued.  Patient verbalized understanding that no further vaccinations are required.
On 11/26/2014 was light headed, dizzy and began experiencing bilateral lower extremity weakness.  On 12/01/20147 symptoms worsened and additional symptoms of tachycardia, chest pain, shortness of breath, and unsteady gait noted. Appointment on 12/03/2014 with PCP labs obtained. Referred to Neurology. 12/12/2014 - Emergency room visit due to worsening symptoms as per neurology recommendations. MRI, performed. 12/16/2014-Neurology clinic visit. 12/19/2014 - Lumbar puncture. 12/30/2014 - cardiology evaluation (Holter monitor ordered).
I do have Atrial fibrillation but I have never had it go on continuously for 5 days; fast heartbeat; fast heartbeat; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on 17Feb2021 (Lot Number: Unknown) as SINGLE DOSE for COVID-19 immunisation. Medical history included atrial fibrillation and rapid heart rate from an unknown date and unknown if ongoing. Concomitant medication included apixaban (ELIQUIS) and sotalol; both taken for atrial fibrillation, start and stop date were not reported. For 5 days, the patient had a fast heartbeat from 01Mar2021 but now she is okay. On 01Mar2021, the patient stated "I do have the atrial fibrillation but I have never had it go on continuously for 5 days before The patient was feeling better now. The outcome of the events was  recovered on unspecified date.  Information on the lot/batch number has been requested.
Started with coughing/chest tightness minutes after getting the shot.  Then started to have a pressure feeling on face and head.  Was given 50 mg of benedryl by nursing staff.  Also experienced nausea and a general feeling of not feeling well.
An autoimmune disease; This spontaneous case was reported by a patient family member or friend and describes the occurrence of AUTOIMMUNE DISORDER (An autoimmune disease) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (An autoimmune disease) (seriousness criterion medically significant). At the time of the report, AUTOIMMUNE DISORDER (An autoimmune disease) outcome was unknown.            No concomitant medication information was reported. It was reported that grandfather, the patient, had been vaccinated multiple times and had been in and out of the hospital. Also stated that grandfather at the time of report had an autoimmune disease. Now that there was overwhelming evidence that Moderna vaccine was killing people and harming people. The reporter did not see why it would be a problem to get money through the court system. No treatment medication information was reported.  Company comment: This spontaneous case concerns a male patient of unknown age, with no medical history information reported, who experienced the unexpected serious (medically significant) event of autoimmune disorder. The event occurred on an unknown date after a dose of mRNA-1273 bivalent BA.4/BA.5. As reported, the patient had been vaccinated multiple times and had been in and out of the hospital and now (at the time of the report) has an autoimmune disease. No further information about the event (including diagnostic findings, final diagnosis, clinical course, laboratory results etc.) was provided. The benefit-risk relationship of mRNA-1273 bivalent BA.4/BA.5 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-707866, US-MODERNATX, INC.-MOD-2023-707867 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-707866:case for mother US-MODERNATX, INC.-MOD-2023-707867:case for father
Describe Event, Problem, or Product Use Error: possible adverse reaction to COVID vaccine had vaccine on Saturday low grade fever, chills, body aches on Sunday Monday felt better but still fatigue Tues felt fine but left shoulder at injection site warm and red yesterday redness radiating down to bicep and getting larger no pus area warm painful to touch
3Sept97 & 20Oct97 recv 1 & 2nd dose vax. 5Jan98 lab eval showed neg varicella zoster AB IgG test.
Antibody test negative. Information has been received from a health professional concerning a 19 year old female, who was believed to be without significant medical history, who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. It was reported that the patient did not seroconvert per the lab titer don. The exact date of the titer was not known but it was recent, on approximately 04-JUN-2006. Unspecified medical attention was sought. No product quality complain was involved.
pt recvd vax;skin color became extreme pallor;felt faint;pt then had tonic type sx involving arms & legs,lasted approx 15-20 seconds;BP 60/40;P 44;placed on exam table to  lie;diaphoretic;BP inc to 108/60 and P 72;