chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist via a company representative refers to a 60 year old female patient. Her medical history, concurrent conditions and concomitant medications were not reported. On 13-OCT-2016, the patient was vaccinated with the dose of ZOSTAVAX (subcutaneously, lot # reported as M0272117, expiration date 26-JUL-2017; dose was not reported). On 15-OCT-2016, the patient developed one large, red, painful welt, which caused her arm to swell and to become inflamed. The patient sought medical attention via speaking to the pharmacist and the pharmacist advised the patient to place ice on the affected area and to take ibuprofen and CLARITIN as needed. The pharmacist did not know if the patient followed her medical advice. None lab diagnostics studies were performed. The outcome of the adverse events was unknown. The relatedness between the adverse events and ZOSTAVAX was not provided. Additional information is not expected as the reporter did not wish to be contacted.
Patient was immunized with 2 doses of Moderna COVID vaccine, second shot on March 30th.  We do not have the lot numbers of her vaccines.  Her symptoms of cough, fever, body aches, headache, and sore throat started on 07/28.   she tested positive for COVID on 7/30/2021.
Developed red, warm, tender area ~8x6cm outer left upper arm - indurated 6 days following vaccine administration
first dose about a year ago, have not received second dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received about a year ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting the patients (about 10 to 15) did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not have specific patient identifiers. The reporter did not consent to follow up. The details were reported for 1st dose of Shingrix.
Congestive heart failure; This is a spontaneous report from a contactable consumer (patient). A 66-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6200, Expiration date: Not reported), via an unspecified route of administration in right arm, on 03Mar2021 at 15:00 (at the age of 66-years-old) as dose 2, single for COVID-19 immunization in a facility reported as other. The patient's other medical history was reported as none. There were no known allergies reported. There were no concomitant medications/any other medications received within 2 weeks of vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6200, Expiration date: Not reported), via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination and didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient experienced congestive heart failure on 04Mar2021 at 00:00. The patient was in hospital for 7 days in 2021 and received unspecified treatment for heart failure. The patient didn't prolong the hospitalization. The event resulted in emergency room/department or urgent care. The event was considered as non-serious and the outcome of event was not recovered at the time of report.
So after I got the shot I had a sore arm for 4 days and when I mean sore I mean pretty sore, if I lifted something it would hurt. It was more sore than the normal for a shot. On Sunday the 14th I woke up with a fever (103F) shortness of breath and a headache, on Mondya the fever was a little lower in the 100s and I still have the shortness of breath. The next day I only had the fever and the whole week I just had a low grade fever (in the 99s) and on Saturday I woke up with high fever again and decided to go get a covid test. My fever broke when I was at the covid test site (Urgent Care) but at night it was back again. My test was negative. I noticed that every time I had high fever, 100s I had shortness of breath - the fever lasted 14 days (low grade for most part). Monday 03/29/2021 at 1:15 I have an appt with my PCP.
Patient received vaccine on 8/11/17. On 8/12/17, I was informed that patient had broken out in hives, no hives near the site of administration (just in other areas).
lightheadedness after about 5 minutes followed by confusion and loss of consciousness. Brief seizure and short-term aphasia.
Rash reaction covering upper arms and chest.   Rash disappeared in three weeks.   Have taking total of 5 Covid 29 shots.  Only had reaction to the last shot.  All shot take was Pfizer.  Last shot was Phizer bivalent Covid 19 booster lot#GL2042.
patient did not receive the full dose due to the syringe leaking; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number KF4T7, expiry date 14th November 2022) for prophylaxis.   On 24th August 2021, the patient received the 1st dose of Shingrix. On 24th August 2021, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.  Additional case details were reported as follows: The pharmacist stated that she was administered the 1st dose of Shingrix to a patient and the patient did not receive the full dose due to the syringe leaking which led to accidental underdose.  The reporter suspected the patient received about 90 percent of the medication. The reporter consented to follow up.
General weakness, imbalance, loss of appetite, incontinence (bowel and bladder). general lethargy, body aches, sleep difficulties, lack of ambition
Extreme pain and injection site, swollen, red, upper respiratory congestion, gritty eyes, diaphoresis, extreme fatigue, muscle aches, nausea, anorexic, flushed, increased body temperature, headache, light sensitivity 2 +
Fluarix vaccine which is expired; This case was reported by a pharmacist via sales rep and described the occurrence of expired vaccine used in an unspecified number of  patients who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra 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 details were provided as follows: The age at vaccination was not applicable for this report. The physician reported that the staff was given expired dose of Fluarix season 2020-2021, which led to expired vaccine used. This case was linked with the case US2021201400, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021201400:same reporter
bilateral sensorineural sloping hearing loss; vertigo; post herpetic neuralgia; herpes zoster; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On or about 05-DEC-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot number and expiry date were not provided) for routine health maintenance and the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after vaccination), the patient suffered a sharp pain in her head and was diagnosed with herpes zoster. As further result of herpes zoster, the patient suffered and was diagnosed with bilateral sensorineural sloping hearing loss, vertigo, and postherpetic neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms resulted in physical limitations not present prior to using vaccine. The patient also experience mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt suffered severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, she had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of bilateral sensorineural sloping hearing loss was determined to be medically significant. The events were considered to be disabling.
Initial report received 23 October 2009 from a consumer, who is the patient's parent. A 17-year-old male patient with a history of Down's syndrome had received an intramuscular injection of INFLUENZA VACCINE and an intramuscular injection of PANDEMIC INFLUENZA A/H1N1 VACCINE (manufacturers unknown, lot numbers and sites not reported) on 21 October 2009 and immediately after vaccination, he became short of breath, his skin became grey-white, his legs were shaking, and his "eyes went in and he said he could not see". The patient was administered oxygen and ephinephrine, and he recovered in the office within a half hour. The patient had no concurrent illness, no known allergies, no concomitant medication usage and he had not received any other vaccine during the previous four weeks. He had no history of adverse events following prior vaccinations. According to the reporter, the patient had symptoms of achy legs, diarrhea and tiredness at the time of the report (onsets not reported) and he had not recovered. Documents held by sender: None.  11/19/09 PCP medical records received, service dates 10/21/09 and 10/22/09. Assessment: Anaphylactic vaccine reaction. Yesterday post-vaccination hypoxia, limp, eyes rolling, wheezing, pallor clamminess. Diarrhea overnight, 'orange worm appearing objects in stool', restless sleep. Legs feel restless, sore, shaky.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. Patient was not pregnant at the time of vaccination. The patient's relevant medical history was not reported. There were no concomitant medications (no other medication in 2weeks). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Indication: Covid-19 treatment; (Jul2022) negative, notes: still negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 and treatment included paxlovid from 14Jul2022 to 19Jul2022.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
2nd vaccine yesterday 01/20/21.  This morning at 1 am started to have headache and this morning 6:30 started mild bodyache.  They are mild but not go away by taking medicine (alleve)
Pt recvd 3 dose of vax on 27SEP91, 11NOV91, & 9APR92 & on 9APR92 following vax pt devel anaphylactic react including anxiety, urticaria, itching & burning, generalized flushing & difficulty breathing;
50 YO received Pediatric dose; 50 YO received Pediatric dose; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 50-year-old female patient who received HBV (Engerix B pediatric) (batch number 333M4, expiry date 7th April 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th February 2023, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 10th February 2023, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product 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 Information: GSK receipt date: 14-FEB-2023 Reporter's comment: The pharmacist called today and reported that a pediatric dose of Engerix-B was administered to an adult patient. The patient´s initials were asked but information was declined because it was not available. The reporter consent to follow up. Additional supportive information: The patient was given pediatric dose of Engerix-B as per the patient's age at time of vaccination, which led to underdose and adult use of a child product.
Vaccine administered was expired.  Manufacturer, state immunization program and guardian were contacted and made aware.
Intractable seizures; Brain damage; Pertussis; Profoundly injured; functions like 2 to 3 years old; This case was reported by a consumer via interactive digital media and described the occurrence of seizure in a 47-year-old female patient who received DTP (A or W not known) (DTP vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of DTP vaccine. On an unknown date, unknown after receiving DTP vaccine, the patient experienced seizure (serious criteria GSK medically significant), brain damage (serious criteria GSK medically significant), pertussis (serious criteria GSK medically significant), injury and behavior abnormal. On an unknown date, the outcome of the seizure, brain damage, pertussis, injury and behavior abnormal were unknown.   It was unknown if the reporter considered the seizure, brain damage, pertussis and behavior abnormal to be related to DTP vaccine. The reporter considered the injury to be related to DTP vaccine.     Additional Information: GSK Receipt Date: 19-Jul-2022. Reporter's Comments: This case was reported by a patient's parent via interactive digital media. The patient was profoundly injured from first dose of DPT vaccine.  The pertussis caused brain damage and intractable seizures. The patient functions like 2 to 3 years old. Additional Supportive Information: Follow-up would not possible as no contact details were available.
This spontaneous report as received from a pharmacist refers to a multiple patients of unknown age and gender. The pharmacist reported that an unspecified number of unspecified patients who received ZOSTAVAX on unspecified dates experienced egg-sized lumps on their arms following ZOSTAVAX administration. The outcome of the event was unknown. The causality of the events with ZOSTAVAX was not reported. This case is linked to #1409USA000505 via same reporter link. Additional information has been requested.
No appetite Headaches Muscle and joint pain Loss of Balance Bruising Nausea and vomiting  Lethargic Nosebleeds after vomiting
Hive about six inches in diameter, circular bright red with some black bruising underneath / red and hot hive Chills Fever 100-101 for 2 days Joint pain in legs/knees Tiredness After 5 days and still sick at day 12 Chronic congestion and coughing resulting Went to doctor on 5/11 since getting worse
twitch under left eye daily, numbness and tingling in fingers and hands daily, pain in left knee area daily, pain in left calf muscle lasted 3 months
After vaccination I had severe soreness in my arm, going down my arm and up to my shoulder.
chills; low grade fever; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration in the right arm on 31Dec2020 11:45 at a single dose for COVID-19 immunization. The patient's medical history included allergies to dairy and infection. Concomitant medication included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) on 10Dec2020 for immunization. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 01Jan2021 06:00, the patient woke up with chills and low grade fever. These were same symptoms as when she had the actual infection. No treatment was received for the adverse events. Outcome of the events was recovering. The events were considered non-serious by the reporter.  The following information on the batch number has been requested.
About 10 days ago I started experiencing vertigo and visited a neurologist who diagnosed me with vestibular neuritis.
Pt experienced syncope within a minute after receiving the vaccine and fell off the exam table. He had pallor and was a bit confused at first. Was oriented x 4 within 1-2 minutes after the syncope. It took about 30 minutes before he was able to walk out of the exam room.
Patient was administered vaccine that was improperly stored (in freezer for too long and considered expired by manufacturer at date of administration due to lack of study data). Patient acknowledged recommendation and will schedule revaccination later this month.
Client anxious regarding being vaccinated. Waited in lobby 15" post vaccination then departed with grandma for home. At 1600 hrs grandma returned to the health dept to report that pt c/o's dizziness & didn't feel well. Advised to have him lie down with legs elevated cool cloth to back of neck. Call if more questions arise.
This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a adult female patient who received Influenza vaccine Quadrivalent. In September 2015, the patient received Influenza vaccine Quadrivalent .5 ml. In September 2015, less than a month after receiving Influenza vaccine Quadrivalent, the patient experienced injection site pain, injection site swelling, injection site warmth and injection site redness. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site warmth and injection site redness were recovered/resolved. The reporter considered the injection site pain, injection site swelling, injection site warmth and injection site redness to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: This case was not previously reported to anyone. The age at vaccination was not reported. The hospital employee who received an unknown Quadrivalent flu vaccine for 2015-2016 season in right arm and experienced injection site pain, injection site swelling, injection site warmth and injection site redness. She noted the side effects were lasted a couple of days but then resolved. The patient did not see her physician or seek medical treatment for the stated injection site reactions. She received the vaccine through the occupation health facility of the hospital. She was not aware of the manufacture of the vaccine she received. On 8th August 2016, the representative stated that, he called at 7 pm last Friday (5th August 2016) to report the incident but GlaxoSmithKline was closed at that time, when he was reminded about the 24 hour reporting policy.
I received the Janssen Covid-19 Vaccine EUA on 3-11/21 at 10:15 AM.   Starting at 3:30 PM  I began having mild body aches; by 5:30 PM the body aches were severe and accompanied by a fever of 100-101 degrees, headache, extreme fatigue and intermittent mild nausea. This lasted throughout the night with body aches severe such that I was awakened by them about once an hour.  By the following morning, Friday, 3-12-21, symptoms were still present but less pronounced, and the headache had abated. Slept most of the day and by nightfall had only lasting fatigue, which was still present this morning, 3/13/21. By this afternoon all symptoms had abated.
Shortness of Breath with cough , generalized weakness, left rib pain radiating to upper back pain (sharp in nature)
Extreme face pain; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PAIN (Extreme face pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced FACIAL PAIN (Extreme face pain). At the time of the report, FACIAL PAIN (Extreme face pain) outcome was unknown. Second dose          No treatment information provided.   This case was linked to MOD-2021-102092 (Patient Link).
Headache approx 12 hrs after shot. Took 650 mg of acetaminophen.  Sore arm at injection site.  Day 1 following shot... chills and fever of 100-101 degrees.  Continued doses of acetaminophen. Hydrated.  Discomfort and swelling of lymph nodes under left armpit.   Day 2 following shot...fever reduced to 99...Continued doses of acetaminophen...Continued discomfort of lymph nodes under armpit
Patient was administered incorrect dosing based on age for Pfizer COVID Vaccine. Patient was given dosing for 5-11 years old instead of dosing for 12 years and older. Patients 2nd dose was given correct dosing based on age.
2 hours after vaccination, she experienced throat, face and tongue swelling, shallow breathing and discharge from eyes and nose. Also a cough saw PCP next day. Symptoms had ceased. She was prescribed OTC BENADRYL which she chose not to take.
Patient was admitted to the hospital for left popliteal artery occlusion within 6 weeks of receiving COVID vaccination.
migraine; This is a spontaneous report from a Pfizer-sponsored program Eliquis patient Ambassador Program from a contactable consumer (patient). A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 14Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 24Mar2021 for covid-19 immunisation. The patient experienced migraine on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.