chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had the flu shot approx 1pm on 10/31/06.  Approx 4 hours later, had two big hives on my neck and felt acky/sick to my stomach.  About 2:00am woke up with tight chest and went back to bed.   About 6:00am, got up for work and my chest was so tight I was crunched over to catch my breath.  This lasted for about 10 minutes and then the chest tightness went in waves, not constant.  I also had a rash on my left side of my kneck for about 1 hour.  This tightness went on for most of the morning but by afternoon was gone.  I did have a headache in the morning, but that did go away  Today,  11/2, I woke up for work and my chest was so tight, for a good 20 minutes.  I did call my husband as I was worried.  I walked around to try and get by blood flowing and it seemed to subside a bit.  The tightness continues still, just in waves.  I also feel a bit feverish(not sure I have an acutal temperature),have a slight headache and am a little light headed. Sorry..I sound like a hypocondriac here but I wanted to share all my symptoms.
24 hours after injection developed fever of 101-102 and redness and swelling at injection site and overall just felt sick.
Hospitalized 10/10/2021; COVID-19 positive 10/5/2021; fully vaccinated  BRIEF OVERVIEW: Discharge Provider: MD, MPH Primary Care Provider at Discharge: MD  Admission Date: 10/10/2021 Discharge Date: 10/19/2021 HOSPITAL COURSE: Patient is an 86-year-old male who presented for evaluation of shortness of breath. The patient has a history of afib on coumadin, HTN, CKD 3. The patient is fully vaccinated for COVID but was exposed at a funeral he attended. He presented to the ER for evaluation. In the ER he was complaining of chest pain which radiated to his back and he was found to be in afib with RVR, rates into the 150s. He was given IV cardizem x2 which improved his heart rates but dropped his blood pressure. He was given IVF and this improved his BP. He had a CTA thorax which was negative for PE but showed COVID pneumonia. He was hypoxic requiring 3 L NC and febrile. His labs showed leukocytosis, lactic acidosis, slightly worse than baseline renal function and indeterminate but down trending troponins.  There was no bed availability in the hospital and the patient was accepted for transfer to another hospital. The patient was unable to get transport to the hospital until 10/10 and during the night had worsening oxygen requirements.  He was on a mask with 12 L on arrival and was transitioned to HFNC. The patient was treated with Remdesivir and Dexamethasone. He was also started on a course of antibiotics for possible superimposed bacterial infection, and completed a 5-day course.  Patient did meet criteria for sepsis at the time of admission however blood in urine cultures drawn showed no growth.  With antibiotics as well as treatment with remdesivir and dexamethasone his oxygen needs were slow to improve.  By discharge, he was able to be weaned to 3 L oxygen, which he should wear at all times.  He was seen by PT/OT, who recommended subacute rehabilitation at discharge. Patient clinically improved and hemodynamically stable for discharge.  Patient was recommended to follow-up with his PCP within 7 days. He will be discharged to rehabilitation faciiity for subacute rehabilitation.  He will be discharged on 3 L oxygen at all times
Fine facial rash. Petechial like. No respiratory issues. No rash on any other part of her body.
HEART PALPITATIONS; DIZZINESS; NAUSEA; HEADACHE; BURNING IN SKIN ON THE NECK; BODY ACHES; GENERALIZED ITCHINESS; FEVER; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's past medical history included migraine, and penicillin allergy. The patient was previously treated with topiramate for migraine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced burning in skin on the neck. On 11-MAR-2021, the subject experienced body aches. On 11-MAR-2021, the subject experienced generalized itchiness. On 11-MAR-2021, the subject experienced fever. On 11-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced dizziness. On 12-MAR-2021, the subject experienced nausea. On 13-MAR-2021, the subject experienced heart palpitations. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning in skin on the neck on 12-MAR-2021, and body aches, heart palpitations, generalized itchiness, fever, nausea, and headache on 13-MAR-2021, and had not recovered from dizziness. This report was non-serious.
This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided.     On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot# M011832, expiration date: 25-JAN-2018 (dose was not reported). The vaccine was exposed to temperature from 32 to 36 degrees Fahrenheit (also reported as 35 degrees Fahrenheit) for 12 hours. Digital data logger was not involved and there was no previous temperature excursion. No adverse effect was reported.  Product quality compliant was not involved. This one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA007887: US-009507513-1701USA007888: US-009507513-1701USA005252:
Patient got a high dose fluad flu shot around 2:30 pm on 12/3/21. Patient returned to the pharmacy around 5:30 pm the same day stating she had hives on her face and her BP was high. I took her BP and it was 190/70.  Patient's daughter called her family doctor and took her to the urgent care.
exercised induced heart arrythmia - ventricular tachycardia. commenced approximately 3 months after the third Gardasil vaccination. Since then developed into frequent ventricular tachycardia requiring 4xcardiac ablations.
Profound fatigue, loss of appetite, continued unabated for 11 days.  Still experiencing mild symptoms now, 14 days later.
Patient fainted after vaccine. Provided medical care, EMS arrived , pt was fine after and refused to go to the hospital
Patient went to his primary care physician. He had blood test done. He was referred to a neurologist and had an EMG completed. He was diagnosed with peripheral neuropathy. He had numbness to fingers in both hands.
This case was reported by a consumer via facebook interactive digital media and described the occurrence of shivering in a 57-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (when patient was young). On an unknown date, the patient received SHINGRIX. On an unknown date, 12 hrs after receiving SHINGRIX, the patient experienced shivering, injection site swelling, axillary lymph nodes enlarged, tremor, muscle spasm, general body pain and muscle pain. On an unknown date, the outcome of the shivering and general body pain were recovering/resolving and the outcome of the injection site swelling, axillary lymph nodes enlarged, tremor, muscle spasm and muscle pain were unknown. It was unknown if the reporter considered the shivering, injection site swelling, axillary lymph nodes enlarged, tremor, muscle spasm, general body pain and muscle pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine on left arm. The side effects the patient experienced after receiveing SHINGRIX were extreme swelling of the shot area (left arm), extreme swelling in the lymph nodes in her left armpit. Twelve hours after the vaccination while trying to sleep, the patient entire body temperature was just above freezing, entire body shaking uncontrollably. The patient teeth were even chattering. The patient wanted to get out of bed to get a couple wool blankets but she could not even move from all the muscle spasms.  Eventually, she forced herself to. Even after covering with two very heavy wool blankets, she was still shivered. After about an hour with the blankets on, it held in enough eat providing minor relief. In the morning, the patient body was so sore. It felt as though the patient ran a marathon. Every muscle ached beyond belief. The patient was certain it was from the shivering from hours. The patient was now 24 hours from when the shivering started and some of the pain was starting to subside. This was the worst of her shot experience. The patient stated that the GlaxoSmithKline should know while they kept track of side effects. If patients did not report, then how would GlaxoSmithKline know.
I had been having some trouble with my arthritis, but within a week or two of receiving my third dose of Moderna, everything got much worse. I started treating with some physical therapy actually before my third dose and that wasn't doing anything. I received a cortisone shot which helped a bit. I received a second one and that didn't help at all. I had a procedure done called an ablation, which also didn't seem to help. It's gotten to the point now, where I'm having trouble even sleeping through the night.
facial swelling; This case was reported by a pharmacist via call center representative and described the occurrence of facial swelling in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number C5E43, expiry date 10th August 2021) for prophylaxis.   On 7th May 2019, the patient received the 1st dose of Shingrix .5 ml. On 8th May 2019, 1 days after receiving Shingrix, the patient experienced facial swelling. On an unknown date, the outcome of the facial swelling was recovered/resolved.   It was unknown if the reporter considered the facial swelling to be related to Shingrix.  Additional details were reported as follows: The patient experienced Shingrix in the left arm. The patient experienced facial swelling on her left cheek the day after she received the vaccine.  The patient consented to follow up. This case has been linked to the case US2019AMR159589, reported by same reporter for same patient.
pt c/o h/a since receiving vax on 14SEP93; children's Motrin helps reduce sx but headaches return p/medicine wears off;
Patient developed a large localized swelling at the vaccine site with body aches and fatigue approximately 2 days after receiving Tdap. She took Ibuprofen to treat symptoms & then ended up in the hospital with a bleeding ulcer.
The next day patient got very sick, the area below the shot has terrible pain, fever. Up to this moment it is very hard to lift. 1st shot is fine but 2nd shot is not.
Felt funny a few minutes after receiving shot. Felt hard to breath, chest tightness, lightheadedness and husband said there was a rash on my chest.  Only lasted 10 minutes and did not receive medical attention so not sure if it was true allergic reaction.  Same thing happened after receiving a flu shot a few years ago and at that time I thought it was just happenstance.  I haven't received a flu shot since.
tingling in her mouth; tingling in her feet; elevated HR; This spontaneous case was reported by an other health care professional and describes the occurrence of PARAESTHESIA ORAL (tingling in her mouth), PARAESTHESIA (tingling in her feet) and HEART RATE INCREASED (elevated HR) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PARAESTHESIA ORAL (tingling in her mouth), PARAESTHESIA (tingling in her feet) and HEART RATE INCREASED (elevated HR). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 10 mg and FAMOTIDINE (PEPCID [FAMOTIDINE]) at a dose of 20 mg. At the time of the report, PARAESTHESIA ORAL (tingling in her mouth), PARAESTHESIA (tingling in her feet) and HEART RATE INCREASED (elevated HR) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, Heart rate: Elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient reports that the follow-up response to treatment was "good" and patient was stable to go home and follow up with PCP.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Pt received vaccination around 9am on 3/18. Started having lip swelling next day and presented back to the pharmacy on 3/19 around 1:15pm. Pt states he was having no tongue swelling or any other symptoms, just swelling of the lower lip. We administered 25mg of benadryl and kept an eye on him in pharmacy for 15 minutes and he said he was feeling fine and would check back with us. Pt is an associate so pharmacy is keeping an eye on him.
Patient came to the clinic after received booster of COVID-19 Pfizer vaccine at 1430, noticed 45minutes to one hour numbness on right side of face, arm and leg, slurred speech noted by her sister. Patient also complained of burning sensation on chest area.
A report from VAERS concerns a three year old male patient. The patient was born prematurely between gestational weeks 32 and 33 and suffered from atrial septal defect. The patient received nasal FLUMIST and 10 days later experienced hypoxic-ischemic brain injury. The patient died of the hypoxic-ischemic brain injury on an unknown date. It was unknown if autopsy was performed. The reporter assessed the event as serious due to death. Based on the information in this report, and awaiting the reporter's assessment, the company physician considered the event to be at least possibly related to FLUMIST.
On Day 11 after getting the vaccine, the vaccine injection site became red and hot, it looked swollen. Around the site it was swollen and red and this went down my whole arm. After a couple of days it went away.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 22-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
I developed a cold sore a few days after each dose.; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 04Mar2021 at 14:30 (at the age of 45-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 25Mar2021 at 14:30 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021, the patient developed a cold sore a few days after each dose. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event cold sore a few days after each dose was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is 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 16-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. 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.
Case previously recorded as MA2009-3731. Initial case report received from a health care professional on 04 NOV 2009. A 9-month-old female patient was accidentally vaccinated with 0.25 mL of FLUVIRIN (batch no. 102041P1) i.m. on 04 NOV 2009. No adverse effect was reported.
This spontaneous report was received from a registered nurse concerning a female consumer who in July 2011 was vaccinated with the first dose of GARDASIL (dose, route and lot # not provided), in August 2011 received the second dose of GARDASIL (dose, route and lot # not provided). No other co-suspects were reported. No concomitant medications were reported. On 30-JUL-2012, the patient was in the office to receive her third dose of GARDASIL (dose, route and lot # not provided). No adverse effects were reported. Additional information has been requested.
Respirations labored, eyes closed, skin cool to touch, excessive drooling, not responding to touch or sternum stimulation.  Resident sent to ER and admitted with low blood sugar and aspiration pneumonia.  Resident is not a diabetic. 11/16/2009 ED records for 11/12/2009, patient unresponsive and with respiratory distress. Patient found to be hypoglycemic, tx: bolus D5W, IVF, IV ABX, cardiac monitoring, IV steroids.
RAISED BUMP AND RASH AT INJECTION SITE ONE WEEK AFTER RECEIVING INJECTION
Right leg swollen with warmth on front and back. Swollen left leg with erythema on front and side of leg with rash.
Headache, neck pain and stiffness, fatigue, brain fog, trouble concentrating, shortness of breath on exertion. Lasting greater than 2 months after vaccine. Followed up with PCP and urgent care. Neurology consult, Long-haul covid clinic consult (awaiting appointment).
Muscle/bone pain, nausea, headache, low grade fever, red rash, (same reaction as previous 4 vaccines but much worse this time) still ongoing
Sore arm at the injection site. Low grade fever. Fatigue. Chills. Several joint aches. Took Advil. Felt better the third day.
Patient began to have symptoms in the middle of the night 8-17-18. Symptoms consist of shivering, headache, stomach aches, stiffness of arm, and feeling hot all over. Mother of patient expressed that she had given patient ibuprofen to help with the body warmth but it did not seem to help. After consulting with MD regarding the reaction to vaccination, it was felt that patient should go to the ER to be evaluated.
This spontaneous report was received from a physician via a company representative and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX via an unspecified route (anatomical location, lot number and expiration date were not reported) for prevention of shingles. On an unknown date, after receiving the ZOSTAVAX, the patient experienced shingles.  The outcome of shingles was not reported.  The relatedness between the event and zoster vaccine live (ZOSTAVAX) was not reported.   Additional information has been requested.
Itchy red rash; Itchy red rash; Hives on neck; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 07Apr2021 at 12:45 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. The patient previously received penicillin and experienced allergy. Concomitant medications included valaciclovir (VALACYCLOVIR) for an unspecified indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 15:00, the patient experienced itchy red rash with hives on neck. The patient did not receive any treatment for the 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 itchy red rash with hives on neck was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 18-Jun-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.   Reporter informed about temperature excursions with freezer in the facility, where she wored. It had been happening for weeks since April 2022. The storage condition at the time of the excursion was reported as frozen storage.  The affected batch lot numbers were reported as 065K21A and 045L21A.  The temperatures excursion range was reported as maximum 30 Fahrenheit degrees and minimum minus18.9 Fahrenheit degrees. The vaccines suffered 2 temperature excursions since April, both of which lasted less than 1 minute. The vials were stored frozen. Visual inspection did not noted any vaccine state change.  No treatment medication were provided.   This case was linked to MOD-2022-591989 (Patient Link).