chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient administered moderna covid vaccine while temperature excursion was ongoing; Patient administered moderna covid vaccine while temperature excursion was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. No treatment medication was reported by reporter.
Day after 330 am - (T) 101.7 vomiting - hot and cold per pt.
VERY EMOTIONAL; SEVERE BODY ACHE; ANXIETY; SEVERE CHILLS; JOINT PAIN; HEADACHE; FELT FEVERISH; SLEPT MOST OF THE DAY; 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 bronchitis, shoulder and hip issue, and the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029) dose was not reported, 1 total, administered on 12-MAR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, after midnight the patient had chills and felt feverish. She was very emotional and had body aches, joint pain which was for about three hours. She had slept most of the day next day and had some body aches and headache. She felt better by Sunday 14-MAR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very emotional, severe body ache, anxiety, severe chills, joint pain, headache, felt feverish and slept most of the day on 14-MAR-2021. The reporter considered the causality between covid-19 vaccine ad26.cov2.s and headache, felt feverish, severe chills, severe body ache and anxiety as related and between covid-19 vaccine ad26.cov2.s and very emotional, joint pain and slept most of the day as possible. Company causality between covid-19 vaccine ad26.cov2.s and headache, felt feverish, severe chills, severe body ache, anxiety and slept most of the day was possible. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
fever of 101.7; chills; sweating and got really hot; sweating and got really hot; really sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (086396). The reporter is the patient.  A 73 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Chronic myeloid leukemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for Covid-19 Immunization; Bnt162b2 (Second Dose), for Covid-19 Immunization. PTs spouse reported PT had a terrible reaction from booster shot for COVID -19 vaccine. PT had a fever of 101.7 and would not allow spouse to reach out to his HCP. PT stated his HCP informed him having the chills was normal after booster shot. PT further shared he was okay the first day after the booster shot but then he was sweating and got really hot. PTs spouse stated he got really sick. When was describing lodging resources available through regulatory authority, PTs spouse reported being on Pfizer medication makes PT afraid. PTs spouse further clarified that PT was informed his feces could be harmful if others encountered it, so PT does not like to sleep at other peoples homes for fear of having an accident/bowel movement. Pt further stated he would not want to infect others. PT additionally informed CC he is overwhelmed with paying bills. [no further info provided]. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever of 101.7"; CHILLS (non-serious), outcome "unknown", described as "chills"; HYPERHIDROSIS (non-serious), FEELING HOT (non-serious), outcome "unknown" and all described as "sweating and got really hot"; ILLNESS (non-serious), outcome "unknown", described as "really sick". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient had sensation of throat closing,  rapid heart rate, trouble swallowing, headache and high blood pressure all immediately - resolved in about 20 minutes
Headache, vomiting, diarrhea. Lasted 6 hours till I started getting faint and having chest pains. Called 911.
Red spots on chest; itching; localized, red rash, gradual onset; petechia on chest, legs & back; dx: thrombocytopenia; suspected meds: rabies or Bactrim; platelets given, Prednisone 20mg TID, Pepcid 20mg BID; neurological exam & VS stable;
The client notified RN that about 12 hours after receiving the second COVID vaccine she woke up in the night with nausea, chills, and dizziness that lasted 2-3 hours. The client stated she consulted with her father who is a doctor who recommended the client take Tylenol. The client stated taking Tylenol improved her symptoms. The client denied any chronic conditions, medications, or known allergies.
This spontaneous report as received from immunization official refers to unknown number of patients of unknown age and gender. Medical history, current conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored GARDASIL 9 (lot # M040412, expiry date: 30-JUN-2019 and M044717, expiry date:19-JUL-2019) intramuscular unknown dose and frequency, for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. No adverse events were reported. Temperature was 0 to 1 degree Centigrade with the time frame of 2 hours. Previous temperature excursion was noted. Call was because of data logger. The outcome of incorrect product storage and no adverse event is unknown. Additional information has been requested.
MILD FLU SYMPTOMS; VISUAL DISRUPTION; SWEATING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced mild flu symptoms, visual disruption, and sweating. The action taken with covid-19 vaccine  was not applicable. The patient recovered from mild flu symptoms, visual disruption, and sweating. This report was non-serious.
Administered flu-shot in left arm and PNEUMOVAX-23 in right arm. Three days later, patient called the pharmacy to report she was experiencing redness, slight swelling and itching in right arm from where the vaccine was administered down to her elbow. Left arm was fine.
throat itching; This is a spontaneous report from a contactable physician.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 17Mar2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced throat itching on 17Mar2021. Patient had reaction about 15 minutes after getting the shot. The patient had throat itching and systematic stuff. Reporter stated his question is if the patient is allergic to what is in the base of vaccine. The outcome of the event was unknown.   No follow-up attempts are possible. Information regarding batch/lot number could not be requested.
38y.o.  female presented with complaints of chest tightness and tingling in left  leg. Received COVID vaccine in right deltoid.
Presented with AMS, mild dyspnea, tachycardia, Dx recent Covid and sepsis; Labs: D-dimer 8.31; CRP 2.87; cpmpleteed Remdesivir PTA; CXR Bilat opacities may represent infection and/or pul congestion Tx: Zithromax, Maxipime, Decadron, Rocephin, heparin; Started on levo with admission; Pt intubated on 12/15; 11/27/21 pt with RRT; intubated, levo gtt; moved to ICU; 11/28 CRRT initiated; 11/29 afib - amio gtt started; 12/7 remains on CRRT, on and off levo; remains intubated, failed weaning trials; 12/9 Changed to DNR; 12/13 off CRRT; transitioned to HD; 12/15 trach placed; eventually weaned to t-collar but then back on vent on 1/5/22; Pt continued to decline and on 1/7 went into asystole
Information has been received from a physician concerning pediatric patient who were vaccinated with Varivax. Subsequently, the patients developed a rash. The physician also reported on another patient (WAES#0203USA01733). Additional information has been requested.
Patient called me on Day 3 post vaccine to report that her right shoulder was very swollen and painful since she received her booster dose. She experience severe headache, chills, and body aches, too which have resolved. Her main concern is the shoulder pain. She's using a sling.  Two children's tylenol did not help.
Initial report was received on 21 February 2011 from a health care professional.  A two year-old male patient who had no illness at the time of vaccination and no reported past medical history had received on 07 February 2011 a second dose intramuscular injection of FLUZONE, lot number U3794CB (site of administration not reported) and HAVRIX, GSK lot number AHAVB462BA (route and site of administration not reported).  On 10 February 2011 the child developed a fever and was diagnosed with a viral illness.  The reporter then stated that over the weekend the patient had seizure activity and his eyes rolled back in his head.  He was taken to the ER (emergency room) where he was diagnosed with myoclonic seizures.  Treatments included Keppra.  No further information was provided at the time of the report.  The patient's outcome was unknown.  Documents held by sender: none.
Case completed primary Covid vaccine series in APril 2021, then case was hospitalized for Covid in January 2022. Hospitalized at:  local Hospital.  * COVID-19 Assessment & Plan Presents after a week with hypoxia, cough, fatigue, anorexia. Positive for Covid. Has had 2 doses of mRNA vaccine but no booster. Lives in multi-generational household. - O2 as needed: currently not requiring it. Will do home O2 test in AM of 1/21 - Dexamethasone (no indication for other treatments at this time as she is over a week in, needs supplemental O2, and is not sick enough for tocilizumab) - Supportive/symptomatic treatments including mucolytics, cough suppressants, throat drops are available
chronic pain in my right shoulder followed by numbness in both hands.  Have had bad circulation for the past month 1/2
Vaccine administered 4/16/07 at public health dept.  Child c/- discomfort eve after vaccines mom gave childrens motrin next morning left arm red hot swollen from elbow to shoulder child taken to Dr. office called here to verify vaccines saying "huge cellulitis" left arm.  Child has mild ear infection saying amoxicillin, benadryl and ice packs ordered - 5 days later rash - amoxil dcd and Zyrtec Rx  4/24/07 child improved.
site is very swollen, bright red, hot to touch, slightly painful. About 4" in diameter.   Has not abated 3 hours after noticing.
Patient reports becoming violently ill and profusely vomiting within 24 hours of receiving the vaccine.
My blood pressure and heart raced for about 13 days.  The 13th day it went back down and on normal dosage of BP meds.
A dark spot appeared on arm; spot began to spread and arm became swollen. Constant pain in arm, healthcare professional performed surgery on arm.
Patient reported upper arm swelling of around 5 and 1/2 inches which started the next day and lasted until 3 days later.  Patient was given Benadryl, ice, and hydrocortisone cream, which didn't help until symptoms resolved at the 3 day mark.
PATIENT CAME TO CLINIC COMPLAINING OF A FEVER FOR THE LAST 5 DAYS.  SLIGHT COUGH, NO OTHER SYMPTOMS.
dying and his Doctor said he may not reach the end of the month; dying and his Doctor said he may not reach the end of the month; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 nos (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: NEAR DEATH EXPERIENCE (medically significant, life threatening), ILL-DEFINED DISORDER (medically significant, life threatening), outcome "unknown" and all described as "dying and his Doctor said he may not reach the end of the month". The events "dying and his doctor said he may not reach the end of the month" required physician office visit. Clinical course: Agent stated the caller reported he has had 2 doses of the Pfizer COVID Vaccine and he is now dying and his Doctor said he might not reach the end of the month. Agent stated he wanted to report this.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe headache, fever, chills, nausea. I have never had such a severe reaction to a vaccine! Worse than when I had influenza A. They have to do something to fix this. I cannot finish the series. This is debilitating and completely unacceptable. Should never have been approved knowing that these reactions are so common and so severe.
A few days after the vaccine I noticed an red, firm, raised itchy rash had developed along the joint area and in the palmar portion of my hand.  I was prescribed an topical steroid cream but only applied it once and the rash went away a week later.
Description taken from patient's email. We were actually airborne I believe around 1500 or so.  A little bit after taking off I began to feel a little bit lethargic, and a short time after that a little bit weak.  As time went on my body started to hurt slightly, as if I were getting the flu.  A few hours into our flight we began refueling.  Shortly after starting our refueling activities I felt a sense of having the flu.  My bones or muscles were extremely achy, though I felt a greater amount of pain in all of my joints.  Fortunately we only did drogue refueling, which required no technical inputs from me that would affect any flight characteristics of either the aircraft I was in, or any of the receivers.  At the time the pain and discomfort was mild.  Shortly after our scheduled refueling had reached its conclusion, and I sat down again and rested.  I felt nauseous and extreme pain throughout my muscles and joints, as well as having a headache.  It became difficult to concentrate and focus on conversations. When the beginning symptoms set on I thought I was reacting to food poisoning.  I have experiences food poisoning which had led to similar symptoms of nausea and joint aching, but then I had realized it had been over 6 hours since I had eaten, and I have never had such a delayed reaction.  Once I had been experiencing the body aching along with cold sweats I recalled that during my first Typhoid immunization injection in 1992 I had an identical reaction, albeit far more severe during the 1st immunization.  During the 1st immunization the body aching was so severe it hurt to move anything.  Everything hurt except to lay still in my bed, and then the pain was limited to throbbing joints.  Though the pain this time was very similar in nature and location on my body, the level of intensity at it's peak was slightly below the previous experience.
Immediately after the shot vision became blurred/distorted. I would not say "double vision" per se, but distorted, blurry, difficult to see.  This cleared within about 2-3 minutes of the shot. After the wait time of 15 min, maybe 20-30 min. later, started having numbness on left side of face and across forehead. Then felt pressure/swelling around both eyes and numbness/tingling in them. Checked in mirror-droopy left eye and less wrinkling in left forehead.  After 4 hours symptoms were not getting better but stronger, so called doctor. Doctor recommended benadryl. Took benadryl and it helped with the eye issue and numbness.  The next day symptoms were back but a bit less severe.  Eyes were swollen and crusted over, numbness and feeling like had eye drops from eye doctor to check for glaucoma.  Eyes were sensitive to light as well. Friday most symptoms seemed much less. Sunday swelling of hands and eyes/face again, right leg weakness.  Drank extra water, symptoms less the following days.  The eye issue is persisting at a low level-light sensitivity after day 6 still, some numbness and swelling that comes and goes.  Right leg weak day 6. Day 7 woke up symptoms appearing less so far today.  Will check with doctor again about the eye issue to see if need to do anything else but it seems to be getting better slowly over time.
lump in the under arm/armpit region that is tender and on the same side she received the injection.; lump in the under arm/armpit region that is tender and on the same side she received the injection.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (lump in the under arm/armpit region that is tender and on the same side she received the injection.) and AXILLARY PAIN (lump in the under arm/armpit region that is tender and on the same side she received the injection.) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (lump in the under arm/armpit region that is tender and on the same side she received the injection.) and AXILLARY PAIN (lump in the under arm/armpit region that is tender and on the same side she received the injection.). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (lump in the under arm/armpit region that is tender and on the same side she received the injection.) and AXILLARY PAIN (lump in the under arm/armpit region that is tender and on the same side she received the injection.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
nausea; minor soreness; This is a spontaneous report received from a contactable Nurse. This Nurse reported for a 91-Year-old female patient that:  A 91-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), dose 1 via an unspecified route of administration on Jan2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and patient's concomitant medications were not reported. The patient experienced Nausea, Minor Soreness on an unspecified date. The outcome of event was unknown.   Information on the lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Pain Narrative: C/O L hand pain and R foot pain after vaccination. New pain. R foot resolved after 15 minute monitoring period. L hand pain (near thumb) continues at end of monitoring period. No other symptoms reported.
Patient said she felt burning hot inside and her throat had a tickle.  Shortly after that, she said she felt nauseous.  She was taken to the emergency department for further evaluation.
Expired dose of Havrix was administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 22-year-old female patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th December 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 30th December 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 30-DEC-2022 Reporters comment: The pharmacist reported that on 30th December 2022 patient received the expired dose of Havrix . The reporter consented to follow-up via email. Additional Supportive information: The patient received the expired dose of havrix vaccine which led to expired vaccine used.
Severe blurred vision; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Severe blurred vision) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03621A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced VISION BLURRED (Severe blurred vision). The patient was treated with NAPROXEN SODIUM at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 11-Mar-2021, VISION BLURRED (Severe blurred vision) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient had increased heart beat, sweating and dizzy. Was transported to ER where she was administered Benadryl IV for 15 minutes. She was then realesed and followed up by primary care. Was prescribed Alprazolam 0.5mg bid and Naproxen 500 bid. Patient feels fine now.
Patient came for dose #2 of Moderna in the primary series.  She was given the wrong color form which indicated Moderna booster, so the patient was given  a 0.25 mL dose.  The mistake was quickly identified and then she given and additional 0.25 mL dose.