chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 04-MAY-2012, patient received improperly stored VARIVAX dose 1, from batch/lot # 1273AA (expiry date, dose units, route and anatomical location were not specified). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
I passed a number of large blood clots (the size of a walnut) from my body on the two days after I received the shot. The day that I got the shot coincided with the day that I got my period, so I was already menstruating when the clots passed from my body. The clots were much larger than normal, and much more frequent. I passed almost a half dozen large clots. By the third day, my menstruation flow started to subside (the first two days tend to be heavier days for me). I did not pass any large clots on the third day going forward.
Patient received Menactra vaccine in early afternoon and left with her family.  Her color was pink and she was walking and talking without difficulty.  I found a message from her mom on my voice mail and called her back.  Mom said that child passed out in the store parking lot after asking to stay in car and they were at the emergency room waiting on test results.  Child did not hit her head per mom.  Mom made decision to take child there after she fainted.  I asked mom to call me back if anything unusual was found during ER visit and she verbalized understanding of same.  Notation made on child's immunication record.
Shortly after receiving Gardasil, pt blacked out and fell off exam table where she had been sitting. Her forehead struck the exam table stirrup, breaking it off, her left thigh scrapped against broken metal from stirrup and pt landed on the floor, where was found the the nurse
patient fainted  several minutes after recieving vaccination, gave her cold packs, and orange juice. she seems completely recovered
This spontaneous report was received from a healthcare professional regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 23-MAY-2016, the patient was vaccinated with improperly stored dose of ROTATEQ lot # L037921 expiration date: 31-MAY-2017 (dose, strength, and route unknown). The vaccine was exposed to temperature of 33.6 Fahrenheit for 12 hours. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Bad pain unrelieved with MOTRIN/TYLENOL for over 2 weeks. Patient had to see a doctor for "pain treatment".
Patient came in to see Dr on 11-18-13. She had a blistering rash on (R) side of body. The swab I did came back (+) for shingles. She had a shingles vaccine in 2011.
pt c/o sl itch under lt arm (tricep area) following the administration of vax, lasting 2 days; no rash, redness noted;
noticed redness & rash like area around site of TD inject hurting all over; felt warm to touch; pt felt badly all over since the vax but did not have the reaction on arm until almost wk later;
Pt had nausea and she vomited. She also felt like she was going to pass out. She said she had not eaten anything prior to receiving the vaccine and she took dose of her amoxicillin without eating prior. She was given some apple juice and popcorn and reported feeling better after consuming it.
This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 143 kilograms, and height was 65 inches. The patient's past medical history included shingles vaccine, and concurrent conditions included alcoholic, and non smoker, and other pre-existing medical conditions included no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-202113:30 for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the subject experienced heart thumping hard in chest. On 06-APR-2021, the subject experienced foggy feeling in head. On 06-APR-2021, the subject experienced shallow breathing. On 06-APR-2021, the subject experienced violent chills. On 06-APR-2021, the subject experienced fever. On 06-APR-2021, the subject experienced excruciating headache. On 06-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced body ache. On 06-APR-2021, the subject experienced nausea. Treatment medications included: paracetamol. On an unspecified date, the subject experienced eye running d/t the pain, couldn't stand the light and sound, pure misery, burning up, and full body shaking/came on like a train wreck. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103.6 F, 100.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart thumping hard in chest, and violent chills on 07-APR-2021, shallow breathing, fever, and excruciating headache on 08-APR-2021, and body ache on 09-APR-2021, had not recovered from fatigue, and foggy feeling in head, and the outcome of nausea, full body shaking/came on like a train wreck, eye running d/t the pain, couldn't stand the light and sound, burning up and pure misery was not reported. This report was non-serious.
Information has been received from a licensed vocational nurse concerning a 69 year old retired female with drug allergy to cortisone, osteoarthritis, osteoporosis, fatigue and constipation who on 16-JAN-2007 was vaccinated with a first dose of Pneumovax 23 (lot number 651320/1008), 0.5 ml intramuscularly in the left deltoid at 9:05 AM.  Concomitant therapy included NAPROSYN, ACTONEL, CITRICAL PLUS WITH MAGNESIUM, CENTRUM SILVER, lisinopril (MSD), docusate Ca, omega-3 marine triglycerides and vitamin E.  On 16-JAN-2007, in the evening, the patient developed pain, redness, felt feverish, and had muscle aches.  On 18-JAN-2007, the patient presented to the physician's office complaining that she felt like she had a fever and her left arm was swollen just below the injection site.  The swollen area of the arm was 23 by 15 centimeters.  There was no fever, temperature was 98.0.  The injection site was clear from erythema.  A confluent papular area started 2.5 to 3 cm below the site and there was an area 23 by 15 centimeters of demarcated erythema.  No laboratory diagnostic studies were performed.  The patient was treated with an ice pack and also continued taking NAPROSYN at home.  The outcome of the events was not reported.  No additional information is expected.
muscle spasms over her entire body; Nausea; more problems breathing; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number: ER2613) via unspecified route of administration, administered in left arm on 20Mar2021 (at the age of 56 years old) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history includes ongoing sarcoidosis from unspecified date in Jul1999. The patient's concomitant medication(s) were none reported. Family history was none reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Additional Administered Vaccines was none reported. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: EN6202) in left arm on 27Feb2021 (at the age of 56 years old) for covid-19 immunisation. On 20Mar2021 the patient experienced that muscle spasms over her entire body, nausea, more problems breathing. Reporter stated the main doctor she sees is her pulmonary doctor. Reporter stated the symptoms she experienced after the second dose was muscle spasms over her entire body, nausea, and she already has problems breathing but she had more problems breathing, muscle spasms over her entire body: Reporter stated this started 40 minutes after she had the vaccines. Reporter stated her hands started doubling over and she started having spams in her hand where she pulled over and had her husband drive. Reporter stated the spasms are sporadically now and not over her entire body. Reporter stated at the same time her husband wanted to take her to the hospital, but she refused, and it might have been stupid, but she is still here. Reporter stated on 20Mar2021 and 21Mar2021 she had what started in her hands and then it was over every place her legs, thighs, stomach, back and after two days the general spasm stopped and now, she just has randomly sporadically spams. More problems breathing: Reporter stated this started around the same time as her spasms started because she has a breathing machine where she takes asthma medicine, and she was able to give herself more breathing treatments. Reporter stated the breathing has not recovered since it is not back to normal, but it has improved. The patient was not hospitalized and not visited emergency room. The outcome of the event was resolved on 23Mar2021, and other events was resolving.  No follow-up attempts are possible. No further information is expected.
pt recv vax 9MAY95 inconsolable unusual crying lasting 7-8 hr; sl fever no local sx; irritable; parents contacted MD next AM given rx for Motrin & will eval for further vax;
Reported by wife;  Husband (client) had chest pressure two weeks after Covid-19 Vaccine around June 2nd and has not experienced that pressure before, wife says. Wife explained it was so severe the husband was taken via ambulance to hospital.
Patient reports a head-to-toe rash with pervasive itching. He has been treated with benadryl and prednisone. He is still currently having itching 10 days later.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 3:25 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 56.75.  Concomitant products were not provided.  On 31-Mar-2021, Excursion time was 9 AM , temperature was 32, total doses given for the day was 199 condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021 respectively, vial was moved to clinic on 31-Mar-2021. 14 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021 respectively.  On 31-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 32, 9 AM: 32, 10 AM: 40, 11 AM: 42, 12 PM: 43, 1 PM: 44, 2 PM: 46, 3 PM: 46, 4 PM: 44.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
I got a headache the morning after the vaccine, and have had a headache some part of every day since then with the exception of three days.  Some days the headache lasts for many hours.  I also have had increased fatigue and intermittent nausea.  For about a week after each injection, the injection site and the whole upper arm became swollen, bumpy and itchy.
less than half of the dose was injected; This case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a patient who received Men B NVS (Bexsero) (batch number ABXA82AA, expiry date 31st January 2022) 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 10th August 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 10th August 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced accidental underdose and pharmaceutical product complaint. On an unknown date, the outcome of the accidental underdose and pharmaceutical product complaint were 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 nurse reported that the patient was administered with Bexsero and the plunger got stuck before entire dose was administered, which led to accidental underdose. Nurse thought that less than half dose was administered to the patient. Nurse enquired that if she should administered another first dose. The healthcare professional did not gave patient's demographic details. The reporter consented to follow up via email.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 88-year-old female patient who received SHINGRIX for prophylaxis. On 23rd January 2019, the patient received the 2nd dose of SHINGRIX. On 23rd January 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 24th January 2019, the patient experienced feeling unwell, appetite lost and nausea. On 25th January 2019, the patient experienced diarrhea and fatigue. On an unknown date, the outcome of the pain in arm, feeling unwell, nausea, diarrhea and fatigue were recovering/resolving and the outcome of the appetite lost was not recovered/not resolved. It was unknown if the reporter considered the pain in arm, feeling unwell, appetite lost, nausea, diarrhea and fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 87 or 88 year. The patient experienced arm soreness on Wednesday that worsened but doing better at the time of reporting. She also experienced not feeling well, no appetite and nausea on Thursday. By Friday she was sick, diarrhea and fatigue. The patient was feeling fair at time of reporting, but was unsure if it was the product or a bug she had caught. Prescribing information was reviewed for side effects and she was referred to her physician. The reporter consented to follow up.
Tingling in lip, swollen lymph nodes ( L axillary), hives (no previous  issues following vaccine administration in the past)
a 15 months old patient received a dose of FLUBLOK vaccine by accident/ No AE; Initial information received on 12-Nov-2021 regarding an unsolicited valid non-serious case from a physician via consumer via Global Medical Information (GMI) number: 00856152.  This case involves a 15 months old male patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] by accident (product administered to patient of inappropriate age).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) for prophylactic vaccination.  On 11-Nov-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (Injection, time interval unit: total, frequency: once, strength: standard lot number: UJ725AA, expiry date: 30-JUN-2022 via intramuscular route in the right thigh for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency: same day).  It was reported "Physician is calling to advise that a 15 months old child received FLUBLOK by accident. Doctor is wanting to know what they should do. Doctor is also asking if it would increase patients Hydronephrosis."  Product used, First time product used : Yes and Still using product : No.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out by the regulatory authority. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Right thigh has swelling larger than quarter size and tactile warmth.  No treatment attempted.  Guardian advised to apply a cold compress and bring her into the office in the morning.
Abdominal pain, Portal Vein Thrombosis (Blood clots in veins to the Liver, Spleen and Large Intestine)  Treatment - Heparin drip and then converted over to the blood thinner Xarelto Recommended that I follow up with my primary care physician and seek the advice of a Hematologist
Patient reported rash on neck that lasted 2 weeks after the vaccination. Injection site was initially very swollen with blisters at the site of injection. Patient had joint and muscle pain that lasted through November and caused her to missed 2-3 days of work each week between August and November. Patient reported being diagnosed with fibromyalgia. Physician told patient other patients with history of fibromyalgia had reported the same response to the vaccine. Patient's most severe response appeared to be bed sore type ulcers on and surrounding both knees and after several office visits tested positive for the chicken pox. Ulcers lasted 2+ weeks, unclear for exactly how long from patient's description. Patient states she had chicken pox as a child. Patient did not report this to the pharmacy until February 12, 2016 when symptoms had resolved.
This spontaneous report was received from a medical assistant concerning to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On an unknown date the patients were vaccinated with unspecified doses of improperly stored GARDASIL, lot # K011215 expiration date 05-MAY-2017, lot # K00120 expiration date 22-JAN-2016, and/or lot# K011562 expiration date 08-APR-2017; (dose, dose number, route and anatomical location were unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Difficulty breathing, weakness, dizziness, vision changes, low back and stomach pressure. Shooting pain down into legs. Pt says he went to ER and had multiple tests ran on him. Pt is recovering currently.
Body aches; fever (100.5); chills; nausea; headache; This is a spontaneous report from a contactable consumer, the patient (patient).   A 60 -years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN6201), via an unspecified route of administration in the left arm on 12Feb2021 at  14:15 as a single dose, for COVID-19 immunization.  Historical Vaccine includes BNT162B2, Dose 1, Lot number EL8982, Administered on 22Jan2021 at 14:30 in the right arm. Medical history included Allergy: Egg intolerance. Concomitant medication includes Prempro, and multi vitamin. The facility in which the vaccine was administered No other vaccines were given within 4 weeks.  On 13Feb2021 at 13:00 the patient experienced Body aches, fever (100.5), chills, nausea, headache. No treatment was  given for the events.  Lab data includes Body temperature 100.5 on 13Feb2021. The clinical outcome of the events Body aches, fever (100.5), chills, nausea, headache were not recovered.
My joints started to hurt and I became less flexible/mobile to the extend that I started walking with my cane and experienced difficulty getting up from a seated position. My Doctor did a a steroid injection in my back but it did not work. I took a couple of pain killers and some muscles relaxers when I could not bare the pain which also did not work (even tried using my conversion table and that did not work and then the pain went away on its own). My doctor passively agreed with me that my pain could have been caused by the vaccine since I suffer from chronic pain and it may have been an autoimmune surge in my system.
11:26 am Pt states "itchy throat like from first shot."  Occ dry cough. Benadryl 25 mg given at 11:27 am. Pt A+O x 3. Talkative to Dr. and myself. No resp distress. 11:32 am pt states itchy throat "all gone." 11:41 am pt left with spouse.
4/21 at 12:40pm:  Face felt tingly/numb.  That went away after a few hours.   4/22 1AM  Fever, chills, body aches. Stayed in bed for 30 hours   4/23 12PM I started feeling better and  moving around but numbness and tingling in my right leg and foot which i thought was because i had been resting did not go away.   4/23 5PM I also noticed a blue spot on my right foot.  I went to a stand alone ER and they check for blood clots and stroke and just sent me on my way and said to take Ibuprofen.  4/24 Same tingling and numbness in right foot/leg and now heavy and weak arms along with headache and nausea.  4/25 Leg feels back to normal and the numbness and tingling has moved to the left arm. The tingling and numbness can be felt running down the side of my arm into my pinky.
Left arm weakness. col to touch; day after vaccination; pt is (R) handed consulted w/Neurology -> suspect autonomic phenomenon.
This spontaneous report as received from a Registered Nurse refers to a female adult patient of unknown age. The patient was administered a 0.5 ml pediatric dose of VAQTA injection (lot # unspecified), route and location unspecified on 06-JUL-2012 and 10-JUL-2012 respectively instead of an adult dose. No adverse events were reported. This is one of several reports received from the same reporter. Additional information is not expected.