chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of passing out in a 20-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). There were no concurrent medications. On 25 June 2009 at 09:45 the subject received unspecified dose of HAVRIX at 1.0 ml in the right arm. On 25 June 2009, immediately after vaccination with HAVRIX, the subject passed out. The healthcare professional considered the event disabling. The event resolved the same day and was considered by the reporter to possibly be related to HAVRIX. Incorrect storage of drug also occurred as it was reported that the HAVRIX administered was left out of refrigeration overnight. No adverse events were reported. The reporting nurse incidentally stated that a lot of teenage subjects pass out when "vaccines" are administered.
Received shingles vaccination 7/15/09. Have had itching and burning on parts of my body. Mostly on stomach and on side of the torso with sometimes burning. Very painful at times. Symptoms began on 8/10/09 and have not clear up yet. Only thing was told to use BENADRY: and cold towels.
Pt reported multiple mouth sores, significant fatigue, hoarseness, sore throat, cough for at least 2 days
ears were ringing; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ears were ringing) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced TINNITUS (ears were ringing). At the time of the report, TINNITUS (ears were ringing) outcome was unknown. Not Provided          No concomitant medication reported   No treatment medication reported
6 days after the administration of the first dose of the Moderna vaccine, I felt ok, but just had a stuffy nose and some sneezing. I have bad allergies so I didn't worry too much. This continued until 11 days after the dose. That was the day I noticed I was having difficulty smelling some things. Some things smelt normal, others I couldn't smell at all.
RDT red, swollen.  Very warm to touch, tender.  Vomiting.
Pt complains of light headedness and dizziness.  BP 127/67, HR 42, RR 18 -- > 119/68, 60s (Atypical).  Back to baseline before being released from vaccination site.
This spontaneous report was received from a pharmacist referring to a 71 year old male patient. The patient had not drug reactions/allergies or concomitant medications. The patient's concurrent conditions included high blood pressure. On 11-FEB-2018, the patient was vaccinated with PNEUMOVAX 23 lot # N020502 with expiration date 08-FEB-2019, for prophylaxis (dose and route of administration were not provided). It was reported that after receiving the vaccine his entire right arm was red and swollen. No treatment was given for the events and no laboratory diagnostic test was performed. At the time of reporting, the outcome of the events was unknown. The causality assessment between erythema and peripheral swelling with PNEUMOVAX23 was not provided.
After 15 minutes I had tightness in my chest, headache, and felt my senses were hypersensitive (visual, focus);  felt "speedy".   I checked my pulse and it was normal (80)
Besides soreness and pain in the arm of my injection site, I had aches and pains in my abdomen, several anxiety attacks throughout the night due to pain, stomach aches, and nausea. I had two sets of hiccups that gave me a headache and caused severe pain in my chest and spine.
Mom called describing fever (103.1 (R)), SOB, rapid heart rate evening /early morning (1AM-3/6/02 Parent treated @ home with Motrin and warm compresses-doing better on 3/6/02-later in day-some leg stiffness.
patient received  1.0 ml  of Fluzone Quadrivalenton, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA297927, 2019SA317307, 2019SA317358, 2019SA317359, 2019SA317360, 2019SA317362, 2019SA317363, 2019SA317364, 2019SA317365, 2019SA317366, 2019SA317367, 2019SA317368, 2019SA317369, 2019SA317370, 2019SA317371, 2019SA317372, 2019SA317373, 2019SA317374, 2019SA317375, 2019SA317376 (same reporter).  This case involves a 26 years old patient (gender not reported) who received a 1.0 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent] (lot UJ223AB, expiry date not reported) via unknown route in unknown administration site (side reported as right) on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of overdose.   At the time of reporting, 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 holders 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.
Initial information received from a healthcare professional on 07 October 2014. A 5-patient (age and gender was not reported), whose medical history and concomitant medications were not reported had received a dose of FLUZONE QIV (batch number UI189AA, expiration date, route, site of vaccination and dose number was not reported) on 26 September 2014. The patient had experienced site reactions, itching, site reactions, warmth and site reactions, bruising, rash on an unspecified date. The patient had no laboratory investigation and corrective treatment was not reported. The patient's illness at the time of vaccination, and pre-existing diagnosed allergies and birth defects were not reported. At the time of this report the outcome of the adverse event was unknown. Documents held by sender: none.
with right leg, severe pain and had DVT diagnosed/ diagnose with DVT (deep vein blood clot) in my leg; This is a spontaneous report from a contactable consumer (patient). A female patient (Age: 60; Unit: Unspecified) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 17Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included COVID-19 from 02Oct2020 to an unknown date. Concomitant medications were not reported. The patient experienced with right leg, severe pain and had dvt diagnosed/ diagnose with dvt (deep vein blood clot) in my leg on an unspecified date in 2021 with outcome of unknown. Patient states she had COVID-19 on 02Oct2020. She received her first Pfizer vaccine dose in her left arm on 17Mar2021. On 01Apr2021, she went to the hospital ED with right leg, severe pain and had DVT diagnosed. She was sent home from the ED with Xarelto. On 07Apr2021, 2nd vaccine dose received by patient. Consumer stated, "I called the health department and I just wanted you to record that I called you guys back on 17Mar I've had my first COVID shot and then 01Apr, I went to the hospital (further details for the hospitalization not available hence not checked as seriousness criteria) and diagnose with DVT (deep vein blood clot) in my leg. I just felt, I just know that what going on right now with Johnson and Johnson but I am just trying to kind of understand that  2 weeks to the day that I had my first COVID shot I came down with the blood clot in my leg. So I just wanted to see if that's anything that I need to concerned, it's very painful, fortunately I have been able to work from home but it's very painful and I did get my second round because level one I need to think about it. So, with everything going on. I never had blood clot now before that I have now."  Information on the lot/batch number has been requested.
Extremely tight and sore arm/ shoulder and neck up to occipital ridge. Hospitalized at later date for Rhabdomyolysis in same problem areas.
A  male patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 16Apr2021 (Lot number and Expiry date was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 16Apr2021, the patient had formed swollen nodes, a swollen kind of region above my left collar bone, patient can't really press into it, it was slightly sore when I press into it. Caller reported his experience after first dose. He recently had first dose on 16Apr2021 and since then well 3 days later he had formed swollen nodes, a swollen kind of region above his left collar bone? He can't really press into it was slightly sore when he pressed into it. Second dose was scheduled for 07May2021. Outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Moderna COVID-19 Vaccine  1/31/21 afternoon  - Began to experience headache at base of neck with pain radiating to L shoulder and down L arm. States pain was severe and persisted all week. States she was seen in Urgent Care on 2/5/21 and referred to ED for further testing.  2/12/21 call to Healthcare professional - states pain is not improved, despite treatment below. States she has upcoming appointment scheduled with Pain Management.
lit rpt: pt recvd 2nd dose of vax & had low grade fever; 5-6 days later pt had progressive weakness of leg inject given; 3 mo after onset ct scan nl; mri neg; clinical impression; L lumbosacral plexopathy;
PATIENT REPORTS BODY WIDE ACHES AND MUSCLE PAINS.  NOT LOCALIZED TO INJECTION SITE.  STATES STARTED AT DAY 10 AND CONTINUES (APPROX 9 DAYS SO FAR)
This spontaneous report as received from a physician refers to a multiple unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unspecified dates, since the "end of March 2016" the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, route, site of administration, dose# and lot# were not reported). Concomitant medication was not mentioned by the reporter. The vaccine was stored at a temperature range of 52F to 55F for a time frame of 40 days. There was no previous temperature excursion involved. The call was the result of a data logger. The physician stated that Merck cannot file a report because the "temperatures recorded are still under investigation". No adverse effects were reported. Product quality complaint was not filed. Additional information is not expected as the reporter did not wish further contact. This is one of the four reports received from the same reporter.
After waiting in office for 15 minutes after receiving GARDASIL vaccine. Patient complain of left knee feeling hot, painful. I assessed left knee, knee was red, swollen, warm to touch. Reported to Dr.  3/5/09 MR received from PCP.  WCC 1/23/09 with normal exam.  Several minutes after vax pt c/o knees feeling hot L>R. Knees erythemic and warm. Improving 30-40" later.   This is in follow-up to report(s) previously submitted on 2/11/2009.  Information has been received from a Registered Nurse concerning a 14 year old female patient with Flu vaccine allergy and gastrooesophageal reflux disease who on 23-JAN-2009 was vaccinated with first dose of GARDASIL (Lot # 659964/1978U) 0.5ml, intramuscularly and first dose VARIVAX (Merck) (Lot #562184/1398X).  There were no concomitants medications.  On 23-JAN-2009 approximately 20 minutes after the patient received vaccines she experienced red and swollen knee.  There were no Laboratory diagnostics studies performed.  At the time on the report on 23-JAN-2009 the patient was not recovered.  Patient sought medical attention was saw by a nurse.  Follow-up information was received via medical records.  The patient has a history of an allergy to a flu vaccine which included sensitivity, bad swelling at site day 3 after IMM.  On 23-JAN-2003 the patient came into the physician's office.  Concomitant medications included ALBUTEROL.  Some minutes after receiving GARDASIL and VARIVAX (Merck) the patient complained of feeling her knees hot;  indeed both knees but more so on the left knee.  The knees were very erythemic and warm to touch (they were normal) during the physical examination (PE) with no movement pains.  Other articulations were within normal limits (WNL).  Subsequently (about 30-40 minutes later) the knees were normalizing as she went home.  Additional information has been requested.
I received the flu shot from a pharmacist and almost immediately felt sick and blacked out. I proceeded to lay down on the ground.
Patient was given second dose of Meningococcal a year to soon earliest date to give would be 7/3/2024. Pt received first dose on 9/26/2019
colonoscopy; This case has been considered invalid since there is no indication that the patient experienced an event under Product PFIZER-BIONTECH COVID-19 VACCINE.   This is a spontaneous report.This male consumer (patient) reported for himself that:  Reporter Subtype: Patient PQC Present: No AE Present: Yes CEP/PSP: 159558(Pfizer COVID-19 Vaccine Call Center)  PQC Details:   Request Name: REQ-383452 Product: PFIZER-BIONTECH COVID-19 VACCINE Question: CEP: 159558.  Consumer said that he already received both doses of the Pfizer-BioNTech Covid-19 Vaccine. The 1st dose on  19Feb2021, and the 2nd dose on 12Mar2021. Right now, he said he is filling up a sheet of paper for his colonoscopy, and is given three choices for what vaccine he has received. The choices were the following: 1.) Covid-19 mrna 100mcg/0.5 ml  2.) Covid-19 mrna 30mcg/0.3 ml 3.) Covid-19 vaccine vector-nr,rs-ad26,pf,0.5ml However, he does not know what to pick so he is seeking Pfizer's help.  The call got disconnected while the consumer was on hold. Placed a callback on 1JUL2021 at 4:25PM EST. Provided outbound call disclaimer.  DSU: E-transmitting; Potential AE. I noticed after the call. Response: Responded from the attached PI, "FACT SHEET FOR HCPs ADMINISTERING VACCINE; FULL EUA PI (v1.0)." "The Pfizer-BioNTech COVID-19 Vaccine is a suspension for intramuscular injection administered as a series of two doses (0.3 mL each) 3 weeks apart." LAB-1451-6.0; Revised: 25 June 2021.  Request Name: REQ-383495 Product: PFIZER-BIONTECH COVID-19 VACCINE Question: "You've been helpful." Response: I thanked the consumer for his feedback.  Follow-up ( 01Jul2021) This is a follow-up spontaneous report. This male consumer (patient) reported for himself that:  Is the Reporter a Healthcare Professional (HCP)? UNKNOWN  Occupation/Specialty: UNKNOWN  Is the reporter the prescribing HCP? UNKNOWN  Occupation/Specialty: UNKNOWN  Suspect Product(s):  Pfizer Covid-19 Vaccine  Start Date:   Stop Date:   Verbatim and Event Description Caller is filling out a sheet of paper for his colonoscopy. On the immunization part on the form, there are multiple choices for Covid 19 Vaccine and he doesn't know what to choose from those 3 choices, Pt is already done with both doses of the Pfizer Covid 19 Vaccine (1st dose - 19Feb2021 and 2nd dose - 12Mar2021) Resolution: - Read Privacy Statement - Gathered info  Medical Information Were any medical questions addressed by this program forwarded/referred to Medical Information? (Live Operators Only) :No Information About Lot/Batch number were requested  Amendment: This follow up is being submitted to amend previously reported information: To route the case to appropriate work flow.
Positive for COVID-19 by PCR test on 7/15/2021.  Patient had mild low grade fever and was exposed to household members who were also positive for COVID-19
Patient reported on 12/24/2015 that he still has some pain at the injection site and sometimes when he tries to swing his arm he feels sharp pain.
reports itching throat, denies chest pain, denies SOB. vital signs stable. Seen and cleared by EMS
Patient was seen for 11 yr physical. Discussed vaccines including Hep A, MENACTRA, Influenza, Tdap and HPV. Parent requested to wait on HPV while they looked more into the vaccine, this request was recorded and the vaccines Hep A, MENACTRA, Influenza & Tdap were ordered. All were given except MENACTRA in its place the declined HPV was given. No adverse reactions reported.
no adverse events reported. realize we gave the covid pfizer pediatric 5-11 vaccine to a 15 year old.   called and spoke to the guardian. they were okay and chose to restart the series in three weeks.
Spondylitis ankylosing aggravated; itchiness; Sweaty; COVID 19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4362309-00 (Agency).  A 33-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since Sep2020 (ongoing) (Batch/Lot number: unknown) at daily (unk , daily (citrate free)), subcutaneous for ankylosing spondylitis. The patient had no relevant medical history and no known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Dec2021, outcome "unknown", described as "COVID 19"; COVID-19 (medically significant) with onset Dec2021, outcome "unknown"; HYPERHIDROSIS (non-serious) with onset Apr2022, outcome "recovering", described as "Sweaty"; ANKYLOSING SPONDYLITIS (medically significant), outcome "unknown", described as "Spondylitis ankylosing aggravated"; PRURITUS (non-serious), outcome "unknown", described as "itchiness". The action taken for adalimumab was dosage not changed. It was unknown if patient was led in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the packaging was discarded.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of sweaty attacks with Humira (Adalimumab). was a reasonable possibility. The reporter's causality for the event(s) of ankylosing spondylitis symptoms got worse, COVID and itchiness was not provided.  Causality for Pfizer BioNTech COVID-19 vaccine (Tozinameran): The reporter's causality for the event(s) of sweaty attacks, ankylosing spondylitis symptoms got worse, COVID and itchiness with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was a possible.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Headache, muscle pain, muscle soreness, nausea. Treatment: HYDROCODONE/ACETAMINOPHEN 5-325 mg 1 tablet Oral Q8H PRN for pain, NAPROXEN 500 mg Oral BID for pain and inflammation, ONDANSETRON HCL 4 mg Oral Q8H PRN  for nausea.
RED BLOTCHY SKIN ON FACE AND HIVES ON FACE, NECK, BACK, CHEST, ARMS. CHECKED BREATHING AND THAT SHE COULD SWALLOW THEN TOOK HOME AND GAVE BENADRYL.
PNeumovax 23 given instead of PCV 13 was given by mistake.As of today almost 24 hrs later Mom states she has had not had any adverse reaction.
This spontaneous report was received from the registered nurse refers to an unknown number of patients of unknown age and gender. On an unspecified date, the patient was vaccinated with RECOMBIVAX HB (dose, route and lot were not reported). On an unknown date, the patients received improperly stored RECOMBIVAX HX. No adverse symptoms reported. At the time of the report the action taken was not reported. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Follow up information was received from the registered nurse regarding 1 day old female patient who on 08-JUL-2014 at 14:46 was vaccinated with improperly stored first dose of RECOMBIVAX HB (lot # J012520, expiration date 30-JAN-2016) intramuscularly. The reporter stated that, between 14-MAY-2014 and 21-JUL-2014, vaccine storage temperature dropped to 0-1 degree in 18 different episodes, and that according to minimum and maximum, all recorded temperatures were supposed to be between 2-8 degrees. It was also reported that the patient was vaccinated with RECOMBIVAX HB on 08-JUL-2014 at 14:46 pm. No symptoms reported. This is one of several reports from the same source. Additional information is not expected because all follow up information was received.
Given vaccine after sitting out punctured for a day.; Given another dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given vaccine after sitting out punctured for a day.) and EXTRA DOSE ADMINISTERED (Given another dose) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given vaccine after sitting out punctured for a day.) and EXTRA DOSE ADMINISTERED (Given another dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Given vaccine after sitting out punctured for a day.) and EXTRA DOSE ADMINISTERED (Given another dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.  No treatment information was provided.
chest pains, leading to a visit to a urgent care clinic, who told us we need to see a cardiologist. They took and EKG and my heart looks fine however they believe i am in pain due to pericarditis. they have for now prescribed me Prednisolone and Colochicine to reduce the pain and inflammation.
About 10 minutes after vaccination, patient stated her left arm and fingers started burning and feeling warm.  Burning sensation followed up to left side of face.  Second dose of injection given on left side.  Patient states she has a scratchy throat.  Vitals taken at 1311: 98.9, 152/98, HR 80, 99% on room air.  50mg IM Benadryl given at 1312 in right deltoid.  Laid patient down on stretcher.  Patient also stated she developed cold like symptoms after her first Covid vaccine injection, and tested negative for Covid.  Vitals rechecked again at 1322: 130/86, 99% on room air, pulse 75.  Told patient to say for another 15 minutes in waiting room.  Patient left at 1345.  Patient stated the burning and warmness had gone away.