chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of tingling of extremity in a 60-year-old female patient who received FLUARIX QUADRIVALENT (batch number 4X24T, expiry date 20th May 2018). On 20th September 2017, the patient received FLUARIX QUADRIVALENT. On 20th September 2017, less than a hour after receiving FLUARIX QUADRIVALENT, the patient experienced tingling of extremity. On an unknown date, the outcome of the tingling of extremity was not recovered/not resolved. The reporter considered the tingling of extremity to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The healthcare professional reported that she was at work clinic and had administered FLUARIX QIV. The patient received the vaccine on the left arm. The patient experienced tingling in arm down to finger tips in the left arm. It happened within minutes after administering. It had been almost an hour after administration, but it did not resolve. No additional side effects were reported.
w/in a few seconds of receiving MMR/DT pt lost consciousness w/jerky arm movements & rigid body; skin cool & clammy;
I just want to let you know that I had a third dose of Pfizer vaccine on September 1. This time on the second day after, I noticed I had redness about 3 inches below the injection site and it's about an inch wide and about 4 inches around the outside of my arm. Doesn't itch or hurt but has been sore. No other symptoms.
The patient was given a dose of the PEDIARIX combination DTaP along with the IPV which gives the patient a double dose of polio vaccine at the visit. No adverse outcomes noted.
herpes zoster/pain; postherpetic neuralgia; vision problems; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered herpes zoster, pain, postherpetic neuralgia and vision problems. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), 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), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of all events was considered as not recovered. The causality between the events and zoster vaccine live (ZOSTAVAX) was related.   The reporter considered all events to be disability.
very tried; legs felt weak; foggy; could not breath; This is a spontaneous report from a contactable consumer or other non-HCP. A 67-years-old male patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on 13Apr2021 08:35 AM (age at the time of vaccination 67-years-old), as a single dose for COVID-9 immunization. The patient's medical history included PAD, has had an operation on each leg; bypass on each leg, had to have a bypass on each leg; and COPD, he may have COPD as well they are still doing tests to see. The patient's concomitant medication was not reported. On 13Apr2021, the patient experienced very tried, legs felt weak, foggy, and on an unspecified date 2021, the patient experienced could not breath. On an unspecified date, the patient underwent lab tests and procedures which included COVID-19 test: he didn't have it, he was having bad coughing spells. The outcome for all the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Muscle pain Joints pain Bone pain Sore body Fever Chills Severe headache Swollen linfonode of left arm Nausea Diarrhea
This spontaneous report was received from a licensed practical nurse and refers to an unknown number of patients of unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The reporter mentioned that on an unknown date, this indeterminate number of patients received a dose of M-M-R II (strength, anatomical location, dose, frequency, route of administration, lot number, and expiration date were not provided) for prophylaxis; which had been exposed to excursion temperatures of 8.6 Celsius degrees on two different occasions (one for 15 minutes and the other for 3 hours). No adverse effects were reported. There was no product quality complaint involved. This is one of four reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1704USA001795: US-009507513-1704USA014014: US-009507513-1704USA014012.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of GARDASIL (strength reported as 120 microgram, dose, lot# and expiration date not reported) that was exposed to 20 F for an unspecified period of time, which was excursion that was unsupported by in-house stability data. No adverse symptoms were reported. Follow up information has been received on 24-APR-2014 from a nurse. The reporter mentioned that "30 patients or less" received improperly stored GARDASIL that was exposed to 20F for 11 days. Administration dates, lot # and expiration dates were not reported. Follow up information was received a health center manager. The patients identifiers were obtained. This report concerns one of the patients. On 03-FEB-2014, at 11:00, the 19 year old female patient was vaccinated with the first dose of GARDASIL (lot # reported as J005661) into right deltoid (dose, route not reported). The medication refrigerator was out of range on the following dates: Jan 07, temperature (Degrees Fahrenheit) 44/26; Jan 09, 36/22; Jan 11, 26/40; Jan 14, 22/26; Jan 16, 26; Jan 20, 28/32; Jan 25, 22; Jan 27, 24/26; Jan 28, 20/20. This is one of several reports received from the same source. Additional information is not expected.
Four to five cm urticavial lesion on right deltoid two cm below injection site. Treated with ice packs and OTC Benadryl.
3:50PM Administered Influenza 0.5 ml IM LD and lot # UT5575BA Exp-6/30/17-Vis data 8/7/15 C/O itching immediately after injection at site.
In September 2000, the patient was vaccinated with his 3rd dose of Lymerix. In December 2000 or January 2001, the patient developed inflammatory arthritis. The follow-up states that on 01/29/2001, the pt had swollen wrists. On 02/28/2001, his hand and wrist pain was worse. On 05/09/2001, he had painful hands. On 09/07/2001, the vaccine provider reported that the vaccinee's symptoms were moderate in intensity and were decreasing. However, the physician indicated that the arthritis was diabling/incapicitating. He stated, "these symptoms occurred over 1 year since vaccine. I do not think there is any relationship."
15 minutes after vaccine was given he developed rash from his wrist to elbows in both arm; Hives on neck; Rash on neck; A spontaneous report was received from a consumer concerning a 73-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events 15 minutes after vaccine was given he developed rash from his wrist to elbows in both arms, hives on neck, rash on neck.  The patient's medical history include hypertension, GERD(gastroesophageal reflux disease), barrett's esophagus. Concomitant medications reported were benazepril 20mg once daily, atorvastatin 20mg once daily, tamsulosin 0.4mg once daily, memantine 10mg twice daily,atomoxetine 25mg twice daily, omeprazole 40mg once daily for drug use for unknown indication.  On 8 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 025A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 8 Mar 2021, the patient experienced the events15 minutes after vaccine was given he developed rash from his wrist to elbows in both arms, hives on neck, rash on neck.Consent for safety follow up She told me that the second Moderna vaccine is not recommended because of these Adverse Events, that recommendation was given from their physician and CDC, as per the wife.  Treatment details included dexamethasone for hives and rash.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, 15 minutes after vaccine was given he developed rash from his wrist to elbows in both arms, hives on neck, rash on neck was unknown.
Approximately 10 minutes after injection, I passed out. Witness said that I was unconscious for approximately 1 minute. My body shook, and it appeared that I had a seizure. Immediately upon waking I started vomiting and having uncontrollable bowel movements for about an hour. I felt confused for about 30 minutes and was unable to speak for a few moments upon waking. When I arrived at the hospital I was still vomiting and having uncontrollable bowel movements. I was given fluids and zofran and sent home without further testing.
Moderna was received from deep freezer on 8/6/21. Was placed in refrigerator on 8/6/21. 30 day expiration date was 9/5/21. Moderna was left in refrigerator and used until 9/13/21. On 9/14/21 we realized we were beyond the 30 days and immediately notified the Pharmacy for direction. The Pharmacists are in communication with Moderna to see if the doses are considered valid or invalid. Risk Management is involved to decide on the best course of action and if we notify the patient before we hear back from Moderna.
use of Engerix B 10 mcg; use of Engerix B 10 mcg; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 45-year-old male patient who received HBV (Engerix B Junior) (batch number EP724, expiry date 14-MAR-2025) for prophylaxis.   On 09-NOV-2023, the patient received Engerix B Junior 10 mg. On 09-NOV-2023, an unknown time after receiving Engerix B Junior, the patient experienced underdose (Verbatim: use of Engerix B 10 mcg) and adult use of a child product (Verbatim: use of Engerix B 10 mcg). 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: 09-NOV-2023 A medical assistant enquired about Engerix-B and what information was available about the information available for the use of Engerix B 10 mcg in adults, the usage of other brands after Engerix-B and the interval to administer the next dose after a dose of Engerix-B which led to underdose and adult use of child product. They provided partial information about vaccine, event and patient. The reporter consented to follow up.  The vaccine administration facility is the same as primary reporter.
Patient broke out in hives. First hives started on neck and belly and by mid day hives were all over entire body and face. Afebrile, some irritability and vomited x1.
Experienced tightness in chest while running, passed out, taken to hospital, had stent installed in heart after a number of tests were performed.
pt had UTI (on Bactrim) @ time of vax administration; states had chills, t102 urinary discomfort worse-onset of sx 24 hr plus post inj; 25APR broke out in hives on 23APR stopped Bactrim started Cephalexin-25APR stopped Cephalexin;
24 HR FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with influenza vaccine for prophylactic vaccination.  The patient received covid-19 vaccine ad26.cov2.s (route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be  requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced 24 hr fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 24 hr fever was not reported. This report was non-serious. This case, from the same reporter is linked to 20210633198.
RESIDENT PASSED AWAY ON HOSPICE SERVICES ON 12/13/21 WITH COMFORT MEASURES IN PLACE
Initial report was received from a health care professional on 02 September 2011. A 47 year-old female patient had received on 01 August 2011 at 10:15 a second dose intramuscularly right deltoid injection of MENACTRA, lot number U3849AA and second dose intramuscular left deltoid injection of ADACEL, lot number U3561CA (sanofi pasteur LTD lot number C3726) and 13 days later on 14 August 2011, the patient experienced stiffness, pain in the neck and shoulders and generalized joint pain. Laboratory tests included: lyme test negative and a CBC sed rate, ANA and rheumatoid arthritis work-up (results not reported). The patient has a history of "E-myon", hypothyroidism, asthma and depression. She was recently diagnosed with right carpal tunnel and was evaluated on 22 September 2011 by a rheumatologist (results not reported). Concomitant medications included SYNTHROID, SINGULAIR, LEXAPRO, ADVAIR and NAPROSYN. Illness at the time of vaccination was denied. No further information was available at the time of the report. The patient's outcome was not reported. Follow-up information received from a health care professional on 10 November 2011 reported that no additional information was available at this time. Documents held by sender: none.
This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Oct2021 (Lot number: FF8839) at the age of 65 years as dose 3 (booster), single for covid-19 immunization. Relevant medical history included: "Dermatomyositis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: No, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (DOSE 2,SINGLE, Dose Number: 2, Batch/Lot No: EN5318, Location of injection: Arm Left), administration date: 27Jan2021, for COVID-19 immunization; Bnt162b2 (DOSE 1,SINGLE, Dose Number: 1, Batch/Lot No: FJ1686, Location of injection: Arm Left), administration date: 06Jan2021, for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 11Oct2021 22:45, outcome "recovered" (Oct2021), described as "Severe rigors 12 hours after vaccination". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills. Additional information: The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient didn't received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. Patient did Not had any Hospitalization Prolonged. Follow-up attempts are completed. No further information is expected.
Reports that she experienced pain down injected arm. Hand weakness, and pain in shoulder and neck.  She did not report these SXS until she went to see her MD on 10/30/15.
diarrhea, fever, numb arm, body aches, headache lightheadedness, decreased appetite, throbbing arm pain, pain when grips anything, fatigue
feel tingling in feet, legs, hands, and arms; tingling like pins and needles in her feet, legs, hands and arms; arm was sore a little bit for the first day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (Batch/Lot number: unknown) at the age of 56 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious) with onset Mar2021, outcome "unknown", described as "feel tingling in feet, legs, hands, and arms"; PARAESTHESIA (non-serious) with onset Mar2021, outcome "unknown", described as "tingling like pins and needles in her feet, legs, hands and arms"; PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "arm was sore a little bit for the first day".  Additional information: The patient was due for her second dose. Patient stated that her arm was sore a little bit for the first day and day or two after the first dose, she had tingling like pins and needles in her feet, legs, hands and arms. Patient stated that was more in her feet and legs and a small amount in her hands and arms. Patient stated that the tingling has gone away in her hands and arms but was still there in her feet and legs and her legs and feet feel like they were asleep. Patient stated she experienced this everyday but not continuously.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
10 hours after my shot, I had a sudden wave of severe nausea, dizziness, and heat and fainted. I slammed my face on the bathroom floor and broke my nose (among other cuts and bruises). After I fainted, the symptoms were gone except for the injuries from fainting and a slight fever and minor queasiness the next 2 days.
UNDERAGED CHILD. DOB STATED ON CONSENT IS DATE. SYSTEM STATES CORRECT DOB IS OTHER DATE. CHILD RECEIVED FIRST  DOSE AND SECOND DOSES OF PFIZER ON 9/8/2021 (LOT#EW0177)
sore throat, headache, cough, body aches, post nasal drainage, nasal congestion.        Patient denies chills, shortness of breath, loss of taste, loss of smell, diarrhea, productive cough, chest pain, wheezing, hemoptysis, fever. starting 12/19/21
05/08/2021 at 08:00AM I woke up with severe pain on my right arm from my fingers to my shoulders, I just laid there and couldn't get up. It lasted for 5 hours and after that the severe pain went away but then I started with fever of 102.4 and the second day it went up to 102 fever and I started taking Tylenol, I felt very fatigue and I had chills, yesterday 11/09/2021 I had my Booster of Pfizer at 11:45AM a and I feel kind of tired and my fever now is 99.3 and I figured by evening it'll go up again. I went online and registered my booster.
sick; couldn't eat; couldn't get out of bed; tremendous headache; joint pains; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), DECREASED APPETITE (couldn't eat), FATIGUE (couldn't get out of bed), HEADACHE (tremendous headache) and ARTHRALGIA (joint pains) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced ILLNESS (sick), DECREASED APPETITE (couldn't eat), FATIGUE (couldn't get out of bed), HEADACHE (tremendous headache), ARTHRALGIA (joint pains), CHILLS (chills) and NAUSEA (nausea). On 06-Feb-2021, ILLNESS (sick), DECREASED APPETITE (couldn't eat), FATIGUE (couldn't get out of bed), HEADACHE (tremendous headache), ARTHRALGIA (joint pains), CHILLS (chills) and NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient contracted the COVID-19 virus in September 2020, and was hospitalized from 26Sep2020 to 30Sep2020. No Concomitant Medications were  provided by Reporter
Pretty sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Pretty sick) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 prophylaxis.    No Medical History information was reported.   On 21-Jul-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 19-Aug-2021, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Pretty sick). At the time of the report, ILLNESS (Pretty sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  It was reported that patient received first shot on 21-Jul-21 and final on 19-Aug-21 After vaccination patient experinced headaches.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Report A0369096A describes a positive test for Hep B surface antigen in a 75 y.o. male who received Hep B vaccine recombinant (Engerix-B). The vaccinee was a hemodialysis patient. Concurrent medications were not specified. On 5/7/02, the vaccinee received a 40 mcg "booster" injection of Engerix-B. On 5/9/02, an unspecified "titer test" was positive for Hep B surface antigen. The reporting nurse had been told that "the false positive may have been due to a reaction with heparin when using the red tube for the collection of blood." A repeat titer was scheduled for one month post-vaccination. The reporter stated that the positive test for Hep B surface antigen may possibly be related to Engerix-B administration.
fever, muscle ache, swollen lymph nodes under my right arm, cold sore in nose
07/23/2014 Patient is being seen by PCP today at 3:15.
Pt is a 44 yo female who received the J&J vaccination on 4/1/2021. She calls this institution on 4/13, reporting sciatic pain, IBS flare ups, and chest tightness that started after her vaccination and have continue since. She has no difficulty breathing. PCP visit on 4/20 showed unremarkable assessment. Patient diagnosed with anxiety during this encounter. Plan to follow up with PCP again in one month.