chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a Certified Medical Assistant regarding multiple unspecified patients of unknown demographics. There was no information about concurrent condition and historical medication. In between 18-NOV-2015 and 15-DEC-2015, the patients were vaccinated with improperly stored doses of VAQTA lot # L039659, expiration date- 15-MAR-2017, (incorrect product storage). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. Temperature was 35F, Time frame was 3 hours, 10 minutes, it was not out of range before and Data logger was Yes. Additional information has been requested.
Spiking a very high fever; A spontaneous report was received from a consumer concerning a female patient of an unknown age who received Moderna's (mRNA-1273) COVID-19 Vaccine and spiked a very high fever.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, approximately two days prior to the onset of the event spiked a very high fever, the patient received their dose of mRNA-1273 (Lot/batch number: unknown) for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the consumer called and stated she was "spiking a very high fever" on day. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event spiked a very high fever was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
Rapid heart rate, throat tightening, trouble swallowing, nausea, lethargic, eye and lip swelling, injection site sore and itchy  Patient called physician and was told to take diphenhydramine 50mg every 4 hours.  Patient did this for 3 days until better.  Did not seek medical treatment at a facility
Fever, chills, muscle pain, nausea,stomach cramps,headache.  I feel worse than the worst day of Covid19.  I feel like I have the flu.
Pt fainted w/out warning sx; c/o tingly painful feeling in lt wrist & under chin & in area of collarbones, throbbing pain occipital area & nausea; Next day still c/o h/a, tingling in arms, chest & under chin;
Time course- ~ 7 minutes  Time onset- < 5 minutes after injection Symptoms- Dizziness, nausea, hot flashes, trembling, intense sweating all over body, malaise, cold sweats, vomiting
"had a little soreness" in their vaccinated arms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 65 year-old male patient received bnt162b2 (BNT162B2), administration date 30Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as ""had a little soreness" in their vaccinated arms".  Additional information: PQC was not present. Patient wife reports that they had a new air-conditioning unit installed and kind of got sick with upper respiratory symptoms: "allergies, post-nasal drip, sinus infections" but have been prescribed an antibiotic and they're feeling much better. Patiet was due for their second dose 21May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Extreme  Fatigue/Lethargic - Wake up tired and not refreshed.  Constant fatigue and sleepiness.  Inflammation beyond belief.  Pain in places that I have never felt.  Left shoulder, Right shoulder, Right leg and left leg tendons.  I am struggling to to normal activities.  Increase in the intensity and severity of the pain, and tenderness and soreness associated with fibroymalgia.  Example: Woke up at 7 am,  had breakfast, Mani/Pedi Appt at 11 am,  Could hardly stay woke for Mani, but slept through the Pedicure.  This is getting to extremely overwhelming for me to deal with.
fatigue for 2 days; swelling, pain, redness, and fever at injection site continuing for over 4 days showing little sign of improvement
Mostly the left leg, my knee just killed me. I got it injected but it is still sore. I started having numbness and tingling sensation. I had very low blood pressure and that may be totally unrelated, I have so much pain on my leg I can't sleep. I was taking trazodone to help me sleep. Once a week I feel like I had gotten the shot all over again and then it goes away. Also two week of the vaccine I had a feeling of my neck down to my feet numb, I did not passed out, I did not faint I was very alert but that happened 3 times since the vaccine a month apart. I have a sensation in my ankles. Tomorrow I have an appointment for MRI to check my legs. I have also been very fatigue, Very fatigue. I'm always exhausted.
Information has been received through the manufacturer pregnancy registry from a 28 year old female physician who on 1/24/02 was vaccinated with a dose of varicella virus vaccine live. There was no local reaction at the vaccination site. Neither varicella symptoms nor herpes zoster symptoms were noted post vaccination. On 3/18/02 the physician found out that she was 6 weeks pregnant. The patient is a G1P0. The approximate date of LMP is 1/27/02 (also reported as 2/3/02) and the EDD is 11/3/02 (also reported as 11/10/02). The patient had a routine ultrasound and AFP which were normal. The patient developed gestational diabetes during the pregnancy. The patient took folic acid 1mg daily during the pregnancy. On 10/25/02 the patient delivered via caesarean section for fetal distress. The infant was a live born normal male weighing 5 pounds 13 ounces. No congenital anomalies were noted. There was no feature of congenital varicella zoster syndrome. Additional information is not expected.
PATIENT HAD BUMPS LIMITED TO INJECTED ARM (LEFT ARM); BUMPS WOULD COME AND GO; GIVEN 1 DOSE OF DIPHENHYDRAMINE 25MG. OBSERVED EVERY 5 MINUTES. AFTER 1ST 5 MINS: RXN LIMITED TO ARM; BUMPS COME AND GO. 2ND 5 MINS: PATIENT FEELS OK; NOTHING ABNORMAL.  3RD 5 MINS: FEELS OK; PATIENT EXITED PHARAMCY AND ADVISED IF FEELS WORSE TO GO TO EMERGENCY DEPARTMENT
This spontaneous report was received from a health professional  refers to four unspecified patients of unknown ages and genders.  Concurrent condition and medical history were not reported. On an unknown date, the unspecified patients could have received improperly stored doses of (Oka/Merck) VARIVAX lot # J012377; expiration date on 03-OCT-2015 (strength, dose #, dose, anatomical location and route of administration were not reported). There was not concomitant medication reported. Product quality complaint was not involved. No adverse effects were informed. Additional information has been requested.
Little or no symptoms for the first 24 hours, then they set in as follows: rapid heart rate >100 bpm even while resting, crushing fever, extreme fever switching between unable to get warm or in succession cold sweats, loss of appetite, fatigue, dizzy with loss of equilibrium,  malaise, pretty much didn't do anything for several days (3 or more)
A spontaneous report was received from a pharmacist concerning a 42-year-old female patient who received COVID-19 vaccine and was administered with 0.3 ml of the vaccine (vaccine under dose). The patient's medical history was not provided. No concomitant medications were reported. On an undisclosed date, prior to the onset of the events, the patient received their first of two planned doses (Lot number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection. While the vaccine was administered, the patient received less than the 0.5 ml dose of the Covid-19 vaccine because the syringe was set to 0.3 ml instead of 0.5 ml. No treatment information was provided. Action taken in response to the events was not provided. The event, administered with 0.3 ml of the vaccine, was considered resolved.; Reporter's Comments: This report refers to a case of 42-year-old female patient administered with 0.3 ml of the vaccine (vaccine under dose) for lot # 030L20A). There were no associated adverse events with the event of vaccine under dose.
Patient reported adverse events starting 2 days after vaccination - anaphylaxis, full body hives, shortness of breath, high blood pressure. States has been to the ER 4 times and prescribed multiple prednisone tapers, fexofenadine, and cimetidine. Reports upcoming appointment with immunology.
This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. On 1st April 2019, the patient received SHINGRIX. On 1st April 2019, less than a day after receiving SHINGRIX, the patient experienced fever, headache, dizziness, nausea, general body pain, swelling arm, pain in arm, difficulty in standing and bedridden. On 2nd April 2019, the patient experienced eye swelling and eye pain. On an unknown date, the outcome of the fever, swelling arm and pain in arm were recovering/resolving and the outcome of the headache and nausea were not recovered/not resolved and the outcome of the dizziness, general body pain, difficulty in standing, bedridden, eye swelling and eye pain were unknown. It was unknown if the reporter considered the fever, headache, dizziness, nausea, general body pain, swelling arm, pain in arm, difficulty in standing, bedridden, eye swelling and eye pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not provided. The patient developed fever, which lasted for 3 hours straight. The patient was unable to stand or get out of the bed for the day. At the time of reporting, the patients arm was inflamed and in extreme pain yesterday and was still very sore but can be touched. The patient would like to know what was to be done and was concerning about getting the second shot since the patient had such bad reaction.
Hospitalized (1.13.22 - 1.18.22);  COVID-19 positive (1.12.22);  fully vaccinated (plus booster - but not 2 weeks out) Admission Date: 1/13/2022 Discharge Date: 1/18/2022 COVID-19 Assessment & Plan Date of Symptom onset: 1/09/2022 Date of positive COVID-19 test: 1/13/2022 Repeat imaging of the chest again does not demonstrate infiltrate, suspect patient's COVID symptoms are primarily upper respiratory and patient's current shortness of breath is related to chronic obstructive pulmonary disease exacerbation Regardless, patient will remain on steroids for chronic obstructive pulmonary disease which provides additional treatment for COVID. DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: COPD with acute exacerbation  Acute kidney injury  COVID-19  HOSPITAL COURSE: The patient is a 61-year-old female who presented with complaints of nausea, vomiting, and shortness of breath.  On presentation the patient was noted to test positive for COVID.  Despite being COVID positive the patient had negative imaging of a chest x-ray.  Patient was requiring 2 L of oxygen to maintain appropriate saturations which the patient states she has as needed at home related to her chronic obstructive pulmonary disease diagnosis.  The patient was started on IV Solu-Medrol as chronic obstructive pulmonary disease exacerbation was the suspected cause of patient's shortness of breath given lack of imaging.  Two days in the patient's hospitalization a repeat set of images were obtained with CT of chest which was negative for acute PE and again negative for acute infiltrate.  The patient was moved to oral prednisone and had remained stable on 2 L of continuous oxygen for 48 hours prior to discharge despite ongoing wheezing noted globally. The patient additionally had noted acute kidney injury on presentation likely related to hypovolemia.  With IV fluid administration the patient had normalization of her renal function.  IV fluids were discontinued in the patient's renal function remained stable throughout hospitalization.  On day of discharge, the patient was feeling significantly better.  She reports significant improvement of her diarrhea.  Questions have been answered to the patient's satisfaction and she is being discharged home in stable condition.
I was vaccinated through a Covid 19 vaccine clinic at work. The injection was given in my left arm. However, I believe the nurse that gave the vaccine may have given it subcutaneously and not IM. The injection was given in the dorsal part of my deltoid muscle. A few hours after vaccination, I had some redness and swelling where the injection was given, about 2 inches in diameter and a large bruise began to form. My arm was very sore for about 3 days. The 2 inch spot stayed raised, but the redness reduced to pink over the next two days and then it was gone. The bruise almost completely was faded away by 1/4/21. This morning (1/5/21) when I woke up, I noticed the 2 inch spot on my arm came back, it was bright red, hot to the touch and slightly itchy. My arm is also a little sore today I contacted occupational health at my work and they notated the reaction in my chart and told me to write a report with VAERS.  Currently I am apply cool compresses a few times a day to the site and applied a small amount of hydrocortisone cream (1%)  to the reddened area.
p/2nd dose of vax pt devel lightheadedness, nausea (no vomiting) no rash but had itching & tight feeling in face & neck
dull headache; lite nausea at times/Occasionally light nausea; eye fatigue along with a sort of "off" feeling; No intense feelings just not a 100% well feeling/Uneasy feeling; This is a spontaneous report from a contactable consumer or other non health care professional. A 68-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration Date not reported) via an unspecified route of administration in left arm on 20Jan2021 at 14:00 as 2nd dose single for COVID-19 immunization. The patient medical history and patient concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration Date not reported) via an unspecified route of administration, as 1st dose single on 30Dec2020 at 12:30 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and not been tested for COVID-19 since vaccination. The patient reported that, he had the Pfizer COVID Vaccine and had the second dose about 6 weeks ago. And still even after the 6 weeks the patient still had some light headaches and some light fatigue and occasionally light nausea, nothing bad, no real intense feeling but just kind of general unwell feeling someday and when you read its side effects supposed to be one or two days. The patient just wanted to see if had still probably common because it still feels the same, he did little long. The patient never had any intense side effects at all it was just slight headache, uneasy feeling, little light nausea. The patient did not received treatment for the events. The outcome of events were recovering.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from the agency via the Freedom of Information Act concerning consumer who reported that her daughter received a dose of GARDASIL and had an adverse reaction. Reaction was not specified. No additional information was provided. Additional information is not expected.
This spontaneous report as received from a healthcare worker refers to a 9 week old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 10-NOV-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally (incorrect product storage). The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies reported. On 15-SEP-2016, a temperature excursion during the storage of VARIVAX took place. Temperature was of -10.9 Celsius degrees for 90 minutes. Data logger was involved. There was no prior excursion. Since that date, unspecified number of patients was vaccinated with unspecified number of doses of improperly stored VARIVAX, lot # M015735, expiration date: 30-MAR-2018 (dose and route were not provided). There were no adverse events reported. There was no product quality complaint (PQC) involved. This is one of two reports received from the same source. Additional information has been requested.
Pain in (L) arm 2 days after vaccine, now entire body aches, muscle aches
6 mo old child rec'd third immun @ 330 on 8AUG90 & experienced 3 sz occuring 830PM on the same day, PE remarkable only for numular eczema; Temp 100.7, p 144 & Respiratory rate 64. Seen in ER.
pt devel bell's palsy p/vax;22SEP97 pt recv vax & 23SEP97 pt noticed a smooth right cheek;they also noted a change in speech, pt could not close rt eye & that mouth seemed not appropriately opening  when smiling;rt eye itchy; This is a folow-up to report (s) previously submitted on 03/06/1998. Information has been received from a physician concerning an otherwise healthy 8 year-old male patient who on 22SEO97 was vaccinted with the first dose of RECOMBIVAX HB vaccine in the right deltoid. On 23SEP97 the parents noticed a "smooth
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was inadvertently vaccinated with ROTATEQ (route, dose and lot # were unknown) which was improperly stored. No adverse effects reported. The temperature range was: 30 Fahrenheit (F) for 360 hours. Follow up information for this spontaneous report has been received from the medical assistant concerning a 5 month old male patient. None pre-existing allergies, birth defects and medical conditions reported. On 03-APR-2014, at an unknown time in the afternoon (PM), the patient was inadvertently vaccinated with ROTATEQ lot # J001257, expiration date: 27-AUG-2014 (dose and route not reported) which was improperly stored. None illness at time of vaccination reported. It was reported that vaccines for children program (VFC) field representative came out and the fridge/freezer temperatures were out of range. The temperature was too low. It had a combination unit which was faulting. The fridge and freezer were replaced and was approved by VFC. Plan of action was taken care of and resolved. Additional information is not expected.
Patient received a dose of Pfizer vaccine.  It was noted that the vaccine 5 day expiration date/time was 5/12/2021 @ 930 am.  Vaccine was administered to patient at 10:10 am on 5/12/2021.  No adverse reactions noted during observation period.  MD and management team aware.
In 11/21/22 I had been coughing for over a year and unable to stop it. I thought it was from postnasal drip. I went to my Pulmonologist he had me take SYMBICORT twice a day. I also took DELSYM cough syrup for two weeks. I started using a NETI POT. I started using a nasal spray, fluticasone propionate. I had a breathing test done on March 3, 2023 that showed I had inflammation in the bronchial tubes. I have a follow up on May 5, 2023 with the Pulmonologist.
Approx. at 2:30 1/8/21 started feeling out of sorts and fatigued, progressed throughout the afternoon and  by that evening was experiencing extreme fatigue, headache, body aches, chills, fever and difficulty sleeping. 800 mg of Ibuprofen was taken around 3am with some relief and was able to sleep, Saturday symptoms continued as Friday evening but slightly lessened in intensity. I am unsure how the fever was on Fri. night early Sat. morning as I was not feeling well enough to get up and check it but Sat. Night around 9pm, rested better but was drenched in sweat throughout the night, Sunday woke feeling better with most symptoms resolved.
Horrible headache that lasted several days that wouldn't go away - worst in my life. Nausea - I wanted to throw up. That was for a few days and I had a slight cough, too. I do still have a lingering deep cough. I used Advil or Tylenol for headache; drank water; taking zinc and Vit C.
Received second dose of COVID vaccine 9/5/21 at 2pm.  Had chills, h/a, stomach ache for a day.  Felt fine for almost a day and then headache returned. No history of migraines/headaches.  Headache is 8/10 on the pain scale and accompanied by blurry vision and fixed spots in her vision.
Fever, body aches, injection site pain, 4 days later?  Not sure which shot produced the lasting side effects. Days 3 and 4 pain behind both eyes upon waking and getting up. subsides as morning goes on.  If this continues, I will see my MD on Monday.
Information has been received from a registered nurse concerning a 5 year old Caucasian male patient with an allergy to amoxicillin, no other concurrent conditions and no past medical history who on 9/27/02, was vaccinated SC in the right thigh with a first dose of varicella virus vaccine live (lot # 641594/0200M). Concomitant vaccination included a dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid and a dose of poliovirus vaccine. There were no chronic medications. There was no illness at the time of vaccination. On 7/1/03, the patient developed a mild to moderate varicella rash. There was no fever and no other symptoms. Unspecified medical attention was sought, but no treatment was required and no laboratory tests were performed. It was noted that therapy with varicella virus vaccine live was discontinued. On 7/8/03, the patient recovered. A product quality complaint was not involved. Additional information is not expected.
Fever, unspecified fever cause. Urinary incontinence, unspecified type. Adverse effect of influenza vaccine "I do suspect that the high fever last night and associated shaking (chills) and possibly the urinary incontinence was an adverse reaction to being given the high dose flu vaccine. Reassured mom that at this present time, patient physically appears ok"
Severe and sporadic itching of entire body 3 days post vaccine which has continued for over a week now (8 days to be exact).  Small rash will sometimes appear however after a few hours will go away.  Benadryl will sometimes help however the itching is not getting better on its own.  Predominately located on all 4 limbs, neck and chest.  Itching is worse towards end of the day, especially at night and for short durations throughout remainder of the day.  Itching to the point of breaking skin to relieve and even then it continues.  I have increased water intake and have to take benadryl at night to even get some rest however once the benadryl wears off it comes back and almost worse.