chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient had shingles twice and received Shingles shot in between. The patient stated that, 200 dollars each and 2 doses needed. Guess, it was not going to happen for could not afford that. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Arm became red and swollen day after shot.  Arm is still red and swollen day 5.  Have taken ibuprofen each day after shot.  Not sure if I should wait longer to see dr.
Patient still has a raised, red, and inflamed area on her right deltoid.  Patient reports having a pain that stems from deep inside her arm, she believes it to be radiating from her bone.  Patient reports that her pain gets worse when it is about to rain.  Patient states that she has to take an Aleve everyday now to control the pain and inflammation.  This patient got her last dose on 06/09/2022 and she has been suffering from these symptoms ever since her Moderna Covid-19 booster dose.
Follow up information has been received from a physician concerning a female patient who on 28- March 2007, was vaccinated on the left arm with a single dose of 0.65 ml of zoster vaccine (Oka/Merck). On 30- March 2007, the patient experienced induration approximately 8 cm with redness at the injection site. No pain or itching. Medical attention was sought. Patient was instructed to go to ER if the condition worse. On 02-Apr-2007 the patient reported that the swelling was gone and only small amount of pink bruising noted. No product quality complaint was involved. Additional information has been requested.
10:15 Received injection, 10:45 fainted and hit back of head on carpet, eyes rolled back in head.
Patient was fine until night after receiving vaccine(Sunday night) developed some soreness around waist on right side going to back which grew worse with rash beginning to develop Monday. The rash not go away and had pain/soreness no stinging, burning or itching that caused patient not to be able to sleep for several days. He saw a dermatologist Friday, who confirmed it was case of shingles. Patient was prescribed valacyclovir orally and triamcinolone and acyclovir topically. He reported to us on 11/2/2020 around 4pm still experiencing rash and soreness.
3 days p/vax fever & vomiting 24 hrs later sz requiring admission to hosp;
This spontaneous report was received from an office manager and refers to a 12 month-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history reported. On 31-OCT-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with an expiration date on 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. No data logger was involved. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517:
Excruciating headache making inability to get out of bed, nausea, myalgia, erythema to injection site with warmth and 5inch swelling
Pt experienced an allergic reaction to the vaccine due to an allergy to eggs. Symptoms started in the morning upon awakening and progressively got worse as the morning progressed at work. She said that she took tylenol and went to bed the night she got the shot and that the symptoms only started the next morning. She said that by 8AM the next day she had diarrhea, vomiting, swollen red itchy hives throughout her arm and it was hot to the touch. It also exacerbated her other allergy symptoms. She had to leave work and was able to get an appointment at her Dr's office . Her Dr. told her to take benadryl and flonase. Her symptoms are subsiding but are not yet resolved.
Arm became incredibly sore about 4 hours after injection.  The soreness was so intense that I felt nauseous when I moved my arm or bumped the injection site. About 11 hours after the injection a severe headache began. Roughly 19 hours after the injection muscle fatigue and overall tiredness began, headache remained as well as arm soreness. About 30 hours after the injection all the symptoms above were present in addition to a fever. Currently it is about 54 hours after the injection and only a slight headache and slight arm soreness remain.
Nausea, vomiting, diarrhea, red rash at injection site, and sore hot shoulder for 3 days. The arm is better now but not the gastric issues.
The pt died suddenly at the babysitter's; dx on death certificate is nodular pneumonitis with allergic component. Mother is concerned that child's allergic reaction was possibly related to vaccine. Received HIB, MMR, PCV-7 on 3/5/02. Per F/U 6/10/02 also had cerebral edema and congestion, scattered colonies of bacterial-type elements within these nodular areas and intra-alveolar hemorrhage.
I had my period when getting the second shot. Instead of ending in two or three days after the time of the vaccination, my period continued for another two and a half weeks. The blood flow was unusually heavy, clotted, and dark. I became anemic as a result of this excessive blood loss and am still trying to rebuild my energy through iron supplements.  (I will never take a Moderna shot again!!!)
1st dose, some arm pain, took Tylenol, nothing major. 2nd dose 103.8 temperature, extreme fatigue/weakness, nausea, achiness, lasted for 48 hours before the fever dissipated. Not fully recovered for 2 days after that. Took Tylenol and Advil as needed.
Rash and intense itching broke out on left arm first, and over the course of a few days, traveled over my entire body - one month later, if any part of my body get heated up (warm water, sitting for period of time, etc.),  I get intense itching and rash.
I started getting symptoms of low grade fever, mild congestion, tiredness, and difficulty breathing. I took an at home COVID-19 test on 5/2/2022 which was positive. On 5/4/2022, I got a rapid COVID-19 test that was positive at my doctors office. I was prescribed a cough medicine, zinc, and Ivermectin. These medications seems to help my symptoms. The fever lasted for 48 hours. The tiredness lasted for 3 weeks. The respiratory issues lasted for 2 weeks.
Started having shortness of breath, lightheadedness; weakened and dizzy. Symptoms came in waves and was intermittent. After 2 hours went to an urgent care locally while on vacation. Had 2 EKG's done and the readings were inconclusive. When I got home from vacation I saw my primary care doctor and was given another EKG, that showed I had a couple of skipped heartbeats. Was given a 30 day heart monitor to wear that I'm still wearing.
legs became very swollen, numb at times, and painful.; legs became very swollen, numb at times, and painful.; legs became very swollen, numb at times, and painful.; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported for herself that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 09Jun2021 as dose 1, single for COVID-19 immunisation. Medical history included blood clotting from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. It was reported that the patient received first dose on 09Jun2021 and one of her legs became very swollen, numb at times, and painful on 10Jun2021. The patient advised they have had blood clotting issues in the past and worried that the vaccine caused another one. The outcome of the events was unknown at the time of reporting. The outcome of the events was unknown.  Information about batch/lot number has been requested.
HEAD CONGESTION; CHEST CONGESTION; WATERY EYES; COUGH; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On OCT-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 01-OCT-2021, the patient experienced head congestion. On 01-OCT-2021, the patient experienced chest congestion. On 01-OCT-2021, the patient experienced watery eyes. On 01-OCT-2021, the patient experienced cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the head congestion, chest congestion, watery eyes and cough was not reported. This report was non-serious.
lymph nodes swelled up; prescribed an antiinflammatory; doctor did not want patient to get second dose at 4 weeks but to check on him in 6 weeks
Very strong headaches causing nausea for 14 days. No over the counter pain relievers helped. I tried ibuprofen, acetaminophen, and Excedrin Migraine. The headache was usually also accompanied by pain behind my eye.
Hives and itching under arms and across chest.  The reaction has steadily gotten worse over the course of 3 days.
Pain in arm; inflammation; muscle soreness; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY, INFLAMMATION, MYALGIA, and INJECTION SITE PAIN in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY, INFLAMMATION, MYALGIA, and INJECTION SITE PAIN. The patient was treated with ALEVE for Muscle soreness and Inflammation, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY, INFLAMMATION, MYALGIA, and INJECTION SITE PAIN outcome was unknown. Unknown          This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY, MYALGIA, INFLAMMATION, and INJECTION SITE PAIN in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY, MYALGIA, INFLAMMATION, and INJECTION SITE PAIN. At the time of the report, PAIN IN EXTREMITY, MYALGIA, INFLAMMATION, and INJECTION SITE PAIN outcome was unknown. Unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On an unknown date post 2nd dose of COVID-19, the patient reported that could not lift his arm up due to pain from the injection. The patient reported that he also felt inflammation and muscle soreness.   The patient reported that these symptoms are ongoing.   Treatment information included an unknown dosage of Aleve.
syncopal episode 8 hrs after vaccine administration with stated elevated HR. Seen at local hospital. R/O DVT.
severe uncontrollable shivering for >3 hours, body was hot, but I was freezing and shivering.
After the Shingrix vaccine was given, I developed redness and extreme itchiness at the site of the injection.  Used cortisone-10 OTC to call inflammation; persisted for 3 1/2 weeks.  Finally subsided.  No other symptoms
Fever of 101 F; Arm pain; Fatigue; Nausea; Dose received: 3/ Dose number =3; This is a spontaneous report from a contactable reporter (consumer or other non hcp). The reporter is the patient.  A 18-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 20Dec2021 at 14:30 (Lot number: 33130BA) at the age of 18 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Constipation chronic" (unspecified if ongoing), notes: Chronic Constipation and "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: TRULANCE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EP6955, Anatomical site: Left arm), administration date: 18Mar2021, when the patient was 17 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EP6955, Anatomical site: Left arm), administration date: 08Apr2021, when the patient was 18 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021 at 14:30, outcome "unknown", described as "Dose received: 3/ Dose number =3"; PYREXIA (non-serious) with onset 21Dec2021 at 06:30, outcome "recovered" (an unknown date in Dec2021), described as "Fever of 101 F"; PAIN IN EXTREMITY (non-serious) with onset 21Dec2021 at 06:30, outcome "recovered" (an unknown date in Dec2021), described as "Arm pain"; FATIGUE (non-serious) with onset 21Dec2021 at 06:30, outcome "recovered" (an unknown date in Dec2021), described as "Fatigue"; NAUSEA (non-serious) with onset 21Dec2021 at 06:30, outcome "recovered" (an unknown date in Dec2021), described as "Nausea". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, pain in extremity, fatigue and nausea.  Additional information:  Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine.  Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
SC administration instead of IM; This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a adolescent female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero (subcutaneous) and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  This case was reported by a nurse via call center representative and described the occurrence of wrong route of administration in a adolescent female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero (subcutaneous) and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong route of administration. On an unknown date, the outcome of the wrong route of administration 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 details were provided as follows: The age at vaccination was not reported. The reporter called to report that a teenager received Bexsero vaccine subcutaneous instead of intramuscular, which led to wrong route of administration  The reporter did not have any further details about this situation at the moment of the call. The reporter consented to follow up.
I experienced a severe migraine and chills. I went to bed and, upon awakening, I felt better.
Patient received vaccines on 9/5/17 and developed projectile vomiting on 9/6/17 and having less wet diapers warranting a MD appointment on 9/7/17.
STOMACH CRAMPS; SEVERE DIARRHEA; BODY PAIN ALL OVER; PAIN MORE IN THE LOWER BACK; SEVERE HEADACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1812072, and batch number: 1812072 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced stomach cramps. On 13-MAR-2021, the subject experienced severe diarrhea. On 13-MAR-2021, the subject experienced body pain all over. On 13-MAR-2021, the subject experienced severe headaches. On 13-MAR-2021, the subject experienced pain more in the lower back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stomach cramps, severe headaches, severe diarrhea, body pain all over, and pain more in the lower back.
Subject in pneumococcal vaccine trial, with severe COPD, died at patient's fathers home on 9/13/28. Vaccination took place on 9/19/07 and death took place on 9/13/08. According to the physician, the relationship to treatment is 'None'. We would be happy to forward the Study's SAE Report Form upon request Subject ID A100099.  6/1/09 Death certificate states COD as acute respiratory failure & severe COPD & hyperlipidemia as contributing factors.  11/4/08 Reviewed SAE form which reveals patient experienced multiple exacerbations of COPD during study participation making death most likely COPD related.  No autopsy was done & there was no hospitalization.  Patient died at home.
Severe fatigue and pain in back near right should blade.  Pain is intermittent and occurs in throbbing pulses lasting from 5 minutes to 2 hrs.
unresolved swelling in her hand; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PERIPHERAL SWELLING (unresolved swelling in her hand) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.  In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (unresolved swelling in her hand). At the time of the report, PERIPHERAL SWELLING (unresolved swelling in her hand) had not resolved.     Concomitant product use was not provided by the reporter.  The patient received booster in fall 2022 in right arm which led to unresolved swelling in hand that still persists. No treatment information was provided.
1508: Patient complained that she felt dizzy and she was about to faint. As she was saying she was going to faint, she started to faint. Nurses were behind her and to the side of her to ease her to the ground. She did not fall, or hit any part of her body. She was immediately assessed by EMT and onsite NP. BP 96/88, P 66, O2 98%, BG 112. 1510: Patient was put on stretcher and given water. Patient immediately felt better. Patient states that she gets anxious and has had panic attacks in the past. She felt nervous about the vaccine. This was her second time taking it. The first time her legs felt very numb and weak. She also felt very anxious the first time she took the vaccine as well. 1520: Patient  stated she felt well and would like to go home. Second set of vitals were taken. BP 117/89, P 70, O2 99%.  Husband drove patient home.
Started having shortness of breath which increased over time for two weeks eventually causing distress requiring hospital ER admit and inpatient admission. Increased work of breathing, diaphoretic, speaking in 1-2 words only. Elevated troponin and BNP found. On CXR, moderate cardiomegaly and CHF found.
redness and swelling of right upper arm x 2d, treated w/KEFLEX
Urticaria, lower lip swelling Improved with antihistamines, no epinephrine
10/7/23: Extreme fatigue, chills, headaches 10/16: uncontrollable crying, congestion, nausea, diarrhea, extreme fatigue 10:19- Present:  extreme fatigue, bilateral conjunctivitis, runny nose, itching all over
Since I have received the vaccine, I have experienced occasional and random tinnitus. I usually notice this a couple of times a day
Patient's granddaughter called in evening & reported pain & swelling in left arm. Also reported chills. Patient went to ER. Pt initially reported no previous pneumonia vaccination but later recalled 1 previous 1 year earlier. Prednisone & famotidine prescriptions presented 11/18/11.
Patient developed a 6 x 6 cm localized area of redness and swelling.
At the point of administration of the vaccine in the left arm the device had a failure, wherein portion of the vaccine leaked out at the needle and the syringe connection. Due to the undetermined amount of the vaccine administered, the pharmacist revaccinated the patient in the right arm (without device failure).