chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant, concerning multiple patients of unknown ages and genders. The patients' medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD, lot #N010865, expiration date 01-OCT-2018, albumin status of recombinant human albumin (rHA) (strength, dose, frequency and route of administration were not reported) and with improperly stored doses of VARIVAX, lot #M000997, expiration date 07-JAN-2018 (strength, dose, frequency and route of administration were not reported) for prophylaxis. The vaccines were reconstituted with a properly stored sterile diluent (lot # and expiration date were not reported). The temperature excursion was reported as 15 °F to 46 °F (23.4°F) for a time frame of 2 hours and 57 minutes. Previous temperature excursion was reported as 6 °F to 14 °F (13.4 °F) for 2 hours. Digital data logger was involved to capture the temperature excursions. No product quality complaint (PQC) was involved. Follow-up information was received on 24-JUL-2018. Additional information has been requested. This is non-valid report due to lack of patient identifiers. Follow-up information was received on 24-JUL-2018 from the medical assistant who provided patient identifiers for the reported event. The patient was a 4-year-old female who on 26-JUN-2018 was vaccinated with improperly stored dose of PROQUAD lot #N010865 with the expiration date of 01-OCT-2018. At the time of the excursion, the vaccine was deemed stable. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1712USA013102: US-009507513-1808USA001953: US-009507513-1807USA012551: US-009507513-1807USA012552: US-009507513-1807USA012553: US-009507513-1807USA012554.
On the third day( May 13) after the vaccine, I started getting a red, slightly itchy rash on the middle of my neck. The rash has been progressing down my neck and is now on my upper chest and covering a larger area. It is now  Wednesday May 19 and the rash is bigger.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain in arm, injection site erythema, inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the pain in arm, injection site erythema, inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown. It was unknown if the reporter considered the pain in arm and injection site erythema to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The patient received SHINGRIX on an unknown arm. The patient's arm was sore as a result of the injection and she experienced the red around the injection site. The patient also expressed concerns because she saw adjuvant liquid shoot out from the vial before mixing it with the antigen and she was concerned about she did not get a full dose, which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. The patient disconnected. She did not want to answer any questions nor provide demographics.
Muscle aches; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 18-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Jul2021 at 10:00 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 as prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 16Jul2021 at 05:00 the patient experienced muscle aches and chills. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event muscle aches and chills was recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
approx 2 wks p/vax pt devel generalized body rash from head to toe; lasted 4-5 days; prior to onset of rash had fever >100; rt leg sore w/lg lump from DTP; all have subsided w/no residual effects;
hemoglobin had dropped 1.1 grams/now anemic; thrombocytopenia; This is a spontaneous report from a contactable physician. A 63-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 10Apr2021 (Lot Number: ER8729) as single dose for covid-19 immunization. Medical history included autoimmune thyroiditis, psoriasis. Concomitant medications included levothyroxine. The patient experienced thrombocytopenia on 13Apr2021, one week later, platelets rebounded but his hemoglobin had dropped 1.1 grams, now anemic. No treatment received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, patient was unknown diagnosed with COVID-19. The outcome was recovering.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events thrombocytopenia and hemoglobin decreased and the suspect drug.  The impact of this report on the benefit/risk profile of the Pfizer product 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 agency, as appropriate.
Patient had anaphylactic shock and was needed to be hospitalized. He is now complete with treatment and ok.
patient became light headed after the shot, remained conscious, but slid to floor after the shot after walking and turned white.  After he ate and drank something, he reported to be fine and in good health
9 Hours after vaccine administration. Patient had onset of severe headache, vomiting with movement, fatigue, fever 101.7 F, soreness in arms at injection sites and joints. Went to ED, tests ran treated for fever and headache and released.
PRESENTED TO ER ON 9/29/21 SECONDARY TO FALL AT HOME.PATIENT WAS FOUDN TO BE COVID +. ON 9/29/21 TRANSFERED TO MEDICAL CENTER FOR HIGHER LEVEL OF CARE.  DX; ATRIAL FIB WITH RVR, HTN, COVID-19-ASYMPTOMATIC. TYPE 2 DIABETES. 10/1/21 DISHCARGED FROM HOSPITAL TO HOME.
Pt immediately started experiencing problems with her digestive system. She relays them being "IBS symptoms" and has tried a probiotic for approx 20 days without symptoms improving. A referral to GI had been done.
PATIENT RECEIVED MODERNA BIVALENT AT PHARMACY ON 1/28/23. ON 2/4/23 THE PATIENT CAME INTO THE CLINIC STATING HE RECEIVED THE WRONG VACCINATION FOR HIS PRIMARY SERIES. THE PATIENT STATES HE NEEDS TO BE FULLY VACCINATED FOR WORK. THE PATIENT WAS EDUCATED PER THE CDC RECOMMENDATIONS TO WAIT 8 WEEKS IN BETWEEN VACCINATIONS BEFORE RECEIVING THE PRIMARY SERIES DOSE. THE PATIENT DECLINED TO WAIT TO THE 8 WEEKS. HE OPTED TO RECEIVE THE 1ST DOSE OF THE PRIMARY SERIES TODAY WITH OUR MOBILE VACCINE CLINIC. ON  2/4/23 THE PATIENT RECEIVED MONOVALENT MODERNA.
Headache nausea fever and chills all of my muscles ache including my toes and my cheeks I'm completely exhausted
Mild redness, mild swelling, moderate itching with onset at Day 8 after vaccination.  No treatment, no complications.
This initial non-serious spontaneous case, received from other health professional on 06-Sep-2017, concerning a 68-year-old female patient. Patient's medical history and concomitant medications were not reported. On 06-Sep-2017, the patient received FLUCELVAX QIV (dose: 0.5ml, batch number: 195226, expiry date: Apr-2018, route of administration and anatomical location was not reported). It was reported that FLUCELVAX QIV is to be stored protected from light and refrigerated between 36 degrees F and 46 F (2 degrees C and 8 degrees C) as stated in the approved product label and must not be freeze. HCP staff states that FLUCELVAX had a temperature excursion between 6:00 PM one day to 7:00 AM the next day (13h) reaching 26.1F maximum. Not frozen. It was reported that, this was the first time for the excursion. Characterized as incorrect product storage. The outcome of the events was not reported. The reporter assessed the report as non-serious.
got really sick from it; This case was reported by a consumer via other manufacturer and described the occurrence of sickness in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The reporter stated that he did not know if he should get Shingrix, just about everyone he knew who got the vaccine, got sick from it on unspecified dates. No patient specifics provided, no dates of administration known. The primary reporter was the consumer, report filed after call ended therefore no demographics were known for the any patients or healthcare professionals. No further information was provided.
Patient bled after injection and had a hard bump at the injection site that was almost the color of a bruise. This happened almost immediately (1-2 min) after injection. Advised pt. to go to urgent care.
She started feeling cold; Uncontrollably shaking that lasted for like 4 hours; Muscle cramps above her stomach; Hard cramps in her 2 legs all night; This is a spontaneous report from a contactable consumer or other non-Health Care Professional and via from a Pfizer sponsored program.   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 1 via an unspecified route of administration on 06Mar2021 as SINGLE DOSE for Covid-19 immunization. The patient medical history was not reported.The patient's concomitant medications were not reported.On 06Mar2021 the patient experienced muscle cramps above her stomach , hard cramps in her 2 legs all night. On 08Mar2021 the patient experienced she started feeling cold, uncontrollably shaking that lasted for like 4 hours. The outcome of events was unknown.  Information on lot/batch number has been requested.
Patient became dizzy and lightheaded after receiving the immunization.  Patient was sitting in exam room chair when he fell over and became unresponsive.  He quickly regained conciousness.  Vital signs and oxygen saturations were monitored.  Patient reported that he had not eaten since early in the morning when he ate one bowl of cereal.  Juice and crackers offered and patient tolerated them without difficulty.  Patient stable at time of release.
feeling under the weather; pain that took her down for a day; felt like a cold with a stuffy nose; felt like a cold with a stuffy nose; felt run down for a day; This is a spontaneous report from a contactable consumer (patient's boyfriend) via Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Expiration date: Unknown) via an unspecified route of administration on 09Feb2021 (45-year-old at vaccination) as Dose number unknown, Single for Covid-19 immunization. This report is related to study or program. The patient's medical history and concomitant medications were not reported. The reporter stated that, his girlfriend took the shot at the exact same time and same place. She did not experience any of those symptoms regarding heart palpitations. She had some issues with feeling under the weather and the pain took her down for a day. He believed this was a more normal reaction associated with the vaccine. The reporter stated that she received the vaccine at the same location at the same time, but he has no way to confirm at this time if it was the same lot number. He does not knew that. He knew that she took it in the same room together. Her experience was quite different. The reporter stated that the patient had significant but not profound reaction. It was like anything other people had when taking it, felt like a cold with stuffy nose. She felt run down for a day. Kind of frankly what he expected he would have had that as well. She considered the reaction she had as "normal". It was an expected reaction to the vaccine as described in the media. Any health care provider who gave it to them would consider her reaction completely normal. No other lasting effects or issues, what so ever. She had nothing with heart rhythm or sweating, or shortness of breath. The outcome of the events was recovered on an unknown date in 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Fever devel 48 hrs p/vax; pt had 2 convuls adm-neg sepsis workup included LP pos; tx w/ IV atb, Pt D/C  72 hrs p/ admit;
I was sick for 6 days after receiving the 1st dose of SHINGRIX (zoster vaccine) 50mcg shingles vaccine. Pain, swelling, muscle ache, tired, upset stomach. I felt like I had the flu. I will be hard pressed to get the 2nd dose given my first reaction.
This spontaneous report as received from a nurse refers to a 11 year old female patient. No concurrent condition or medical history was reported. On 08-JAN-2016, the patient was vaccinated with first dose of GARDASIL 9 (dose 1, lot # L020015, exp. 16-AUG-2017, intramuscular). The patient experienced few symptoms of headache, dizziness and becoming white but did not experience any hearing issues. On 11-MAR-2016, the patient was vaccinated with second dose of GARDASIL 9. The concomitant therapy included unspecified allergy medicine. On 11-MAR-2016, the patient experienced an instant headache, became dizzy and completely white before the nurse had even finished pushing the dose. The nurse lifted the patient's feet applied a cold cloth and monitored the patient for 20 minutes in the office. The patient recovered from the symptoms a few hours later after leaving the office on 11-MAR-2016. The causality assessment was not reported. No product quality issue was involved. Additional information has been requested.
Started feeling lethargic around 7. At 8 pm I started feeling nauseous. At 8::30 I started getting chills, and by 9pm I had a fever. I was achy, nauseous, and have chills/ a fever until the next day around 11am. I took aspirin and Advil in intervals during this time. After my fever broke my appetite came back for a little bit. After 11am on Thursday  I have had a headache and I?m extremely fatigue. I?ve been none stop sleeping for the past two days. Today I am feeling better but I?m still extremely tired even after restarting my adderall.
site of vaccine (upper left arm) has a round red, swollen, itchy spot, not better after 7 days. The circle is  the size of a silver dollar. On the seventh day it was itching more than at first.  I put Cortizone Cream on it and am calling my physician tomorrow.
About 5-6 days after vaccine injection on 1/15/21, I developed a rash, itching, and pain on the same arm as my injection. It is also warm to the touch. I went to Urgent Care and they think it is cellulitis from the vaccine. I am on Bactrim DS to see if it will help. My blood pressure was low as well, not sure if it's related but usually by pressure is fine. I had cupping done at the chiropractor on 1/22 on my neck and back, symptoms started later that evening. Not sure if is is a coincidence or not.
ARM HURT / PAIN AT THE ARM; DIARRHEA; MINOR FEVER; This spontaneous report received from a consumer concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included: breast cancer, and mastectomy. 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 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the patient experienced arm hurt / pain at the arm. On 10-APR-2021, the patient experienced diarrhea. On 10-APR-2021, the patient experienced minor fever. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm hurt / pain at the arm, diarrhea, and minor fever on APR-2021. This report was non-serious.
After the 1st dose - glands swelled up, went to ER. 2nd dose - super tired and more pain in the arm, swelling still was there since the 1st dose. ENT and pain management doctors all said that it was normal that it was normal for my condition. Had neck surgery in 2017.
Experienced common side effects of injection site soreness, fatigue, headache and mild fever for 24-48 hours.  Unexpected side effect was positional vertigo (dizziness), which started approximately 16 hours after vaccination, while turning over in bed.  Vertigo has continued with varying levels of dizziness and disorientation for 14 days.  Went to the doctor to address this on-going issue.
Rash/hives, +itching: began at injection site right deltoid, spread to trunk & thighs, not face or hands. No fever.
So after the second vaccine, I got it that Thursday and got a sore arm on Friday which is normal I guess but on Saturday morning I woke up with blisters all over my hand. I called the DR and he ordered medication. I went into my DR on Monday and sure enough it was the shingles. It was very painful; it was even in the palm of my hand. I took the medication for eleven days and it went away - I took Valacyclovir, and after the time frame it went away.
I started to feel fatigued and slightly dizzy at 12:30 pm the day I received the shot which would have been about 5 hours after. I also had a low grade fever of 99.2 and arm pain at the injection site. That evening I began to have chills and fever, fatigue, body aches, and nausea. These symptoms lasted until the evening of 1/15/2021. Fever was on and off during that time and ranged from 99.2-100.7.  My arm was very sore during this time and on 1/16/2021 it became very itchy and hot at the injection site so I took Zytrec which helped some with the itching  and was like it this for about 24 hours then subsided.  I did not go to the doctor because my symptoms were not severe and I recovered at home.
Patient woke up on 5/26/2021 at 8:00AM feeling extremely tired and fatigued.  She was not able to get out of bed for three days. She still felt bad on 5/29, but was able to get out of bed. On 5/30/2021 she felt a lot better and was able to do her normal daily activities. On 6/2/2021 she woke up and had slurred speech and was really tired and fatigued again. She went to bed hours earlier than normal. Her husband four her unresponsive by her bed later that night. The patient could not move her lower extremities and could not open up her hands or even talk. She had to be helped back onto her bed. They called 911 and when the ambulance arrived the patient's husband said the patient had a blood pressure of 70/??. They brought her to the hospital where he said they diagnosed her with pneumonia and myocarditis. She was in the hospital from 6/3/2021 at 2:00 am until 6/13/2021 12:00PM. She still has a lot of weakness and cannot walk far without being out of breath and exhausted.
I have a history of insomnia, Bipolar II, and ADHD. Last night, about 10 hours after getting the vaccine, I had some insomnia. This might be unrelated, but I want to bring it up. About 18 hours after the vaccine, I started to get chills, become clammy, both hot and cold at the same time, and slight fatigue. 24 hours after my vaccine, I noticed that my headache got worse, i felt much more fatigued, and my head felt warmer.
Rash with vesicles some open areas, with slight ulceration appeared all at once.  Symp tx.
Pt recvd 1st dose of Hep B vax on 10FEB92 & w/in 1 wk of receiving vax pt devel rash on face w/itching; exp noc sweats, joint pain & fatigue;
Patient received injection at 9:38am at approximately 9:45am patient complained of felling flushed, hot hard to focus and diaphoretic and nauseated. He was assisted to a reclining position using two chairs.  BP 122/70 pulse 63 O2Sats 97%. patient remained in a reclining position for 15 minutes, he was then assisted to a sitting position BP 114/80 pulse 81 O2SATS 97.  Patient was given bottle of water to drink and left facility without further problems.
Pain and swelling in arm pit of vaccinated arm, itching "knots" heat from skin at vaccine site
2 months old girl with one day history of emesis, starting on the morning following her first series of vaccines.
13 year old patient received the Pfizer COVID-19 vaccine, dose 1. (under age per EUA).  no symptoms reported by guardian
After the pharmacist administered the Pfizer Covid 19 vaccination on my left arm, my right whole side of my body went completely numb 15 minutes after. As I walked to my vehicle in the parking lot, my whole right side was feeling weird  and the numbness persisted.
LEFT SHOULDER PAIN - INCREASING ON ACTIVE RANGE OF MOTION OF ARM FORWARD AND ABOVE HEAD.  THIS PAIN STARTED AFTER INJECTION AND HAS PROGRESSIVELY GOTTEN WORSE.
Recieved Jannsen vaccine at 11:15 AM on March 23rd. Rash on hands, arms, feet, and legs appeared at 5:00 PM on May 3rd. It itched and burned and was difficult to sleep. No medication was taken, but by morning the rash was nearly gone and by midday it seemed to be gone. Around 5:00 PM, it started back again. I took Diphenhydramine because it appeared to be an allergic reaction. This helped me get to sleep. It was gone in the morning again, but started back in the evening again. This happened repeatedly for a total of 5 days.
Nausea, hands and mouth tingling, face felt flush, lightheaded, symptoms persisted until approximately 2:30 pm the same day
weakness, nausea, vomiting, chest pain, cold sweats, heart palpitations
High heart rate  Very painful headache  Fever  Stabbing pain in arm from even small movements  Tiredness
First night 101 fever, body aches, extreme fatigue, headache nausea. Saturday 12/18/21. Took Celebrex and tylenol generic. Fever spiked at 102.5. Chills, extreme fatigue, shaking , nausea, joint pain and body aches, tooth sensitivity. Sunday 12/19/21 fever of 101 body aches, fatigue, shaking, chills, headache. Monday 12/20/21 (today) headache fever of 99.1 fatigue, headache.
Chronic allergic reaction.  Severe itch, rash, welts, hives and discomfort
About 5 days after the shot i woke up with pains in my thigh along w tingling,numbing,burning sensations in my left leg.  Persistent for about 2 weeks slowly getting better. About 10 days later same inmy left arm. Also feeling flush & hot flashes & sweats