chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a 12 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 17-JUL-2014 the patient was vaccinated with first dose of GARDASIL (dose, frequency and route of administration were not reported) (lot # J009293, expiry date: 23-APR-2016) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for GARDASIL. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA013014 (same reporter link). Additional information has been requested.
Flushed, post-vaccine. Felt weak and dehydrated after standing outside. BP 170/96, HR 100, O2 sat 96%. BP 142/95, HR 88, O2 sat 96%.
I was just a little sleepy that morning and that was about it on side effects but it didn't last but maybe an hour or so.  We- test weekly at work and I was tested due to my partners 92 year old mother visits a lot and I wanted to be safe and that is when I tested positive for COVID-19 at home and another test that was PCR and they were both positive.  I went to the emergency room on the 4th and received the MAB therapy infusion.
No adverse effects; The primary reporter reported that 1 patient was administered a dose of improperly stored VARlVAX; This spontaneous report was received from a licensed practical nurse, regarding a 5-year-old patient. The patient's concomitant medication included a well-stored sterile diluent (DILUENT MRK INJ). The patient's medical history, concurrent conditions and drug reactions or allergies were not provided.        On 25-JUL-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX), lot # R018139 with expiration date 25-JUN-2020, for prophylaxis (dose, frequency, route and anatomical location were not provided). The administered doses of vaccines underwent a temperature excursion between -9°C to 8°C (8°C) during 16 hours and 7 minutes, as recorded by a data logger. There were not previous temperature excursions. No adverse effects were reported.
Developed cold chills on the same evening I received the vaccine at 9:00 pm through the night - developed a low grade fever of 99.2 (taken after treating myself with Tylenol) the very next day on 04/10/21 - in addition to running a fever all day and night of 04/10/21 - I experienced extremely painful body aches and random piercing pain?s throughout my body which began and lasted throughout the entire day and night of 04/10/21 - I also experienced dizziness on the evening of 04/10/21 - I also experienced fatigue as well on 04/20/21. Today is 04/11/21 & I am having some residual body aches but not as severe as the day before and some random piercing pains throughout my body.
Full Syncope episode (-) fall or trauma.  Was A/o x 30 seconds post event.   No other symptoms reported.
Ice was applied to the injection site on 11/5/15. After removing ice the following were noted: swollen area w/a spilled milk design; the area was red, blue/purple and later became warm to touch. Later that day I saw a Dr. in local urgent care who diagnosed me with allergic reaction to flu shot injection and I was prescribed prednisone 5 mg 1 twice a day, redness subsided bit area that was red is now black.
Information has been received from a health professional concerning a male infant who was vaccinated with an oral dose of Rotateq (Lot# 654795/1374F). It was reported that the patient was brought into the office a month after he had received Rotateq. The patient's belly was distended and was in respiratory distress and was not breathing. An NG tube was put in to relieve pressure in the patient's stomach so he could breathe. It was reported that the patient recovered. No product quality complaint was involved. No other information was provided. The patient's experiences were considered to be immediately life-threatening and other important medical events by the reporter. A lot check has been requested. Additional information has been requested.
Hospitalization: 3/3/2023 - 3/10/2023 (7 days) Presentation to the ED: SOB. COVID + date: 3/8/23 Treatment: no specific treatment. patient was treated for new onset AFIB. Discharge to: home.   031L20A 2/11/2021 027A21A 3/11/2021 045J21A 12/9/2021
1 week after 1st dose, I began feeling irritation around the injection site.  I am experiencing swelling of approximately a 3 inch area, redness, itching, warm and hard to the touch.
blindness in left eye; hearing loss; seizure; pneumonia; liver failure; herpes zoster; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or about 14-OCT-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On unknown dates, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered from herpes zoster, blindness in left eye, hearing loss, seizure, pneumonia and liver failure. As a result of these symptoms, the pt was seen and treated by medical providers and had been still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt 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, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered/not resolved. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events of blindness unilateral, deafness, seizure, pneumonia, hepatic failure, and herpes zoster were considered to be disabling. Upon internal review, the events of blindness unilateral, deafness, seizure, pneumonia, and hepatic failure were determined to be medically significant.
I had covid at the end of Aug, it's been 90 days since I recovered and tested negative.; I had covid at the end of Aug, it's been 90 days since I recovered and tested negative.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Batch/Lot number: unknown), on 23Mar2021 as dose 2, single (Batch/Lot number: unknown), on 29Sep2021 as dose 3 (booster), single (Lot number: 301558A) and on 04May2022 as dose 4 (booster), single (Lot number: PP4554) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history included: "had flu shot just the other day" (unspecified if ongoing), notes: Prior Vaccinations (within 4 wk):had flu shot.Not within 4 weeks of 4th dose Covid shot, 4May2022. Concomitant medication(s) included: SIMVASTATIN taken for blood cholesterol abnormal. The following information was reported: VACCINATION FAILURE (medically significant) with onset 23Aug2022, outcome "unknown", COVID-19 (medically significant) with onset 23Aug2022, outcome "recovered" and all described as "I had covid at the end of Aug, it's been 90 days since I recovered and tested negative.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Aug2022) Positive, notes: Looks like he contracted Covid  23Aug2022 and it was gone 31Aug2022; (31Aug2022) Negative, notes: Positive for Covid: Looks like he contracted Covid  23Aug2022 and it was gone 31Aug2022. Paxlovid was taken as therapeutic measures for covid-19.  Clinical information: Patient periodically took 10mg Simvastatin to help keep his cholesterol numbers low and remove any plaque. Thought he was supposed to take it every day but his numbers have been very low, the last year and a half kind of stopped taking it and has asked doctor if ok to take it periodically or if he is still supposed to take every day. He has not been taking it.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
12 hrs last had 104+ fever (axillary) leg hot & very erythematous 50cm diameter; Also had "shaking" - like tremors; When examined, no other problems;
Initial information received on 28-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a six months old female patient who supposed to vaccinated with a 0.5 ml  second dose of PENTACEL (lot C5422AA and Exp. Date not reported) via unknown route in the left thigh on 28-Nov-2018. The patient's medical history and concomitant medications were not reported. It was reported that, gave the clear liquid portion of the PENTACEL vaccine without the powder. It was an actual medication error due to wrong injection technique. No any information reported whether patient experienced any adverse event. 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 in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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. List of documents held by sender: none.
The problems started in October. It started with blurred vision, but mild. Then a week later, my vision was wavy and had spots. I saw the eye doctor, who diagnosed a rental tear in the right eye. I went to a local eye department and did a laser treatment in the office for what they called a horseshoe tear. In November the problems began, more light floaters and more blurry. Doctor did another laser treatment and also saw some blood. Then in late November saw a different doctor specialist, and then another one in the beginning in December. The eye continues to be blurry and have floaters.
Pt recvd 3 doses of hep B vax, 3rd was recvd 11SEP90 & pt was not seroprotected p/ 3rd dose.4th dose was given 30NOV90 & titers were positive.
4/21/2011 Developed viral pharyngitis then laryngitis. 5/10/2011 Re-developed sore throat, followed 5/13/11 by loss of taste (ageusia). No recovery to date.
A report has been received from a Pharmacist concerning an adult, subject of unknown gender, who had been receiving Nasal FLUMIST QUADRIVALENT. The patient was over the age of 49 years, it is considered as off label use; consumer who is over the age of 49 years received the intranasal vaccine. FLUMIST QUADRIVALENT (Intranasal) started on an unknown date. The outcome of the event of off label use; consumer who is over the age of 49 years received the intranasal vaccine is unknown. The report was considered to be non-serious by the reporter.
Body aches, 102 temp, dizziness, headache, CPX with Motrin, Benadryl. Follow up if headaches increase or symptoms increase.
This spontaneous report was received from a physician via company representatives, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 08-APR-2014, the patient was vaccinated with an unspecified improperly stored dose of PNEUMOVAX 23 "10 single dose 0.5mL Vis 10SDV" with lot number J009689 and expiration date of 29-JAN-2015 (route of administration and anatomical location were not reported), which was stored at 33 Fahrenheit (F) degrees (0.555555556 Celsius) (lowest recorded temperature) for a total of 72 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported nor was product quality complaint involved. This is one of several cases received from the sane reporter. Additional information has been requested.
Vaccine was given to pt. and myself at about 6:30 in the evening on 4/4.  This was the 4th dose for each of us.  The only prior side effect experienced by either of us was a slight soreness to the arm receiving the shot.  By the afternoon of the 5th pt. was feeling tired and was having trouble walking with her cane.  On the morning of the 6th movement was difficult.  Pt was dragging her left leg entirely -- Pt has limited use of her left leg due to MS, and uses a cane for short to medium distances.  Longer distances require the use of a scooter.   Wednesday she stayed home from work and largely stayed in bed -- using a walker to access the bathroom.  By Wednesday night, however, she was able to move more freely and that continued to this morning.  Pt has non-episodic MS and this scenario seems akin to an MS episode.  Perhaps the vaccine triggers an episode.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 64-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included pravastatin sodium (Pravastatin), quinapril, metoprolol succinate (Toprol) and testosterone (Testosterone Injection). On 31st January 2019, the patient received the 1st dose of SHINGRIX. On 1st February 2019, 1 days after receiving SHINGRIX, the patient experienced pain in arm, fever, headache, dizziness, spasms, dry heaves and constipation. On 6th February 2019, the patient experienced hemorrhoids. In February 2019, the patient experienced loose stools. On an unknown date, the outcome of the pain in arm, fever, dizziness, spasms, dry heaves, constipation and hemorrhoids were recovered/resolved and the outcome of the headache and loose stools were unknown. It was unknown if the reporter considered the pain in arm, fever, headache, dizziness, spasms, dry heaves, constipation, hemorrhoids and loose stools to be related to SHINGRIX. Additional details were provided as follows: The patient reported arm soreness for 7 days, fever, dizziness, headaches, back spasms, dry heaves, constipation, loose stools, and a popping of an anal hemorrhoid.  The symptoms had improved at time of report. The reporter consented to follow up.
On 06/11/2021 I had the second dose and on 06/12/2021 I started to have flu like symptoms and then on 6/13/2021 the tinnitus started. I felt pressure in the back of my head as well as like feeling weakness and fatigue and some anxiety. I decided to call my doctor and they got me in like 5 days after that. They checked my ears and my throat, and they had a specialist looked at my symptoms and suggested steroids, but they decided not to do steroids because it would affect the efficacy of the vaccine. They suggested to do mediation, yoga, or acupuncture. I still have the tinnitus.
pt recv vax 5DEC95 & pt devel chicken pox 21MAR96;pt had classic skin lesions & fever
The pt. developed noticeable itching and redness at the injection site the same night as the vaccines were administered. upon awakening, the pt. experienced increased swelling, rash, pain, redness, site warm to touch, loss of appetite, and fatigue. Pt. initially tried Ibuprofen and ice to treat symptoms, but offered little relief. The rash continued to spread so pt. sought treatment at the local emergency room, where she was given a prescription for hydroxyzine.
Had soreness in arm, fatigue, headaches that same day.  But next morning is when bad effects started.  Extremely dizziness like vertigo, ringing in ears, worse in the right one, nausea, aches.  Today still have ringing in ears, especially right one (this seems to have gotten worse),  dizziness, nausea very bad. Still soreness in arm.  Headaches and fatigue seem to be getting better.
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 44-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 19 November 2010, 20 December 2010 and 20 May 2011 the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (1 ml, unknown route, unknown deltoid). On 22 July 2011, 63 days after the 3rd vaccination with ENGERIX B, 7 months after the 2nd vaccination with ENGERIX B, and 8 months after the 1st vaccination with ENGERIX B, the subject experienced not responding to therapy. The subjects titers were drawn on 22 July 2011 and were less than 0.1 (units not provided). At the time of reporting the subject had not been restarted on vaccination series for hepatitis B. This case involves a pharmaceutical product complaint. The healthcare professional reported that she had seen an increase in non-responders to vaccination with ENGERIX B and was concerned about the vaccine. It was noted that all the vaccines are monitored by several methods for temperature excursions. The healthcare professional reported 7 cases of not responding to therapy following hepatitis B vaccination. This is case 3 of 7 (see case IDs A0947199A, A0947239A, A0947241A-A0947244A for details of the other reports). Follow-up received from the reporting healthcare professional on 18 October 2011: On 21 July 2011, the subject's hepatitis B surface antibody was less than 0.1 mIU/mL (immunity was noted by the healthcare professional as greater than 0.99). All 6 doses of ENGERIX B were administered intramuscularly in the left deltoid. The healthcare professional reported that the ENGERIX B series would be repeated and the 1st dose of the 2nd series was administered on 06 October 2011.
"vaccine second shot, he developed constant headaches, nausea,(Allergies related symptoms)from that time."; nausea; Allergies; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the parent. An 11-year-old male patient received BNT162b2 (BNT162B2), in Dec2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1; Manufacturer: Unknown), for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as ""vaccine second shot, he developed constant headaches, nausea, (Allergies related symptoms) from that time.""; NAUSEA (non-serious), outcome "unknown"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Allergies". Additional information Subject: Patient Assistance, Customer Verbatim: Dec2021 my son, 11-year-old, received Pfizer kids vaccine second shot. He developed constant headaches, nausea (allergies related symptoms) from that time.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Large itchy, tender, swollen and hard red area surrounding injection site. No treatment except icing
Pain to (L) shoulder with movement and up (L) neck. Began 09/23/13, have taken Ibuprofen and rest.
I had shingles after the vaccine!/Suspected vaccination failure; I had shingles after the vaccine! / worst six weeks of my life; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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 case was reported by patient. The age at vaccination was not reported. The reporter had shingles after the vaccine. The worst six weeks of his life. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Received Vaccine and 5 minutes later in Observation Room Vomited.    Recovered. Stayed in Observation room 30 minutes, no repeat of vomiting.  Left with parents
Foggy; No appetite; Still feels so exhausted; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Foggy), DECREASED APPETITE (No appetite), PYREXIA (Fever) and FATIGUE (Still feels so exhausted) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune arthritis.   On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PYREXIA (Fever). On 09-Feb-2021, the patient experienced FEELING ABNORMAL (Foggy), DECREASED APPETITE (No appetite) and FATIGUE (Still feels so exhausted). On 06-Feb-2021, PYREXIA (Fever) had resolved. At the time of the report, FEELING ABNORMAL (Foggy), DECREASED APPETITE (No appetite) and FATIGUE (Still feels so exhausted) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, Oxygen saturation: 97% (normal) normal.         No concomitant medication was reported. No treatment details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow-up received on: Additional initial document added: Telephone contact report, outcome of events and medical history was added.