chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient had been inadvertently administered an expired ActHib, no AE; Initial information received on 02-Sep-2020 regarding an unsolicited valid non-serious case received from a health care professional.  This case involves a 15-month-old female patient who was inadvertently administered an expired HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  Medical history, past medical treatment, vaccination and family history were not provided.  Concomitant vaccination included a dose of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunization.  On 01-Sep-2020, the patient received 0.5 ml dose of suspect HIB (PRP/T) VACCINE (lot UJ077AAA and expiry date: 21-aug-2020) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out 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.
2nd dose planned to be given on February 10th 2022 but health care provider wasn't sure since that dose of Kinrix expires on February 8th 2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug prescribing error in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS TOXOID + POLIOMYELITIS VACCINE + TETANUS VACCINE TOXOID (KINRIX).   On an unknown date, the patient received the 2nd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced drug prescribing error. On an unknown date, the outcome of the drug prescribing error 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 reported as follows: Age at vaccination was not reported. The patient received 1st dose of Kinrix with expiration date 8th February 2022.  The second dose was planned to be given on February 10th 2022 with same expiration date so HCP (Health Care Professional) was concerned about this situation and wanted to know how to proceed, which led to drug prescribing error. Consent to follow up was denied.
Scared before injection. Syncopal episode after injection recovered after lying down. Mom reports nausea for few hours after.
vaccine #1 June 4, 2018, There was no 2nd; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On 4th June 2018,the patient received 1st dose of Shingrix and batch number ZY3X4).   On an unknown date, the patient did not receive 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 Information: GSK Receipt Date: 20-JUL-2022 Reporter's Comment: The case was reported by the patient.  The second vaccine was not administered.  The reporter wanted to know was the first still valid or should it be repeated. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
The day following the injection the client's left arm from the injection site to his elbow was red and very itchy.  A few days later the redness traveled down to his forearm and a bumpy rash also appeared from the injection site to the forearm. The client reports that his arm is so itchy that he has not slept much since 01/28/2021. The client sought medical attention on 02/17/2021 and was put on a prednisone taper. The client indicates he feels the rash and itchiness is "a little better". The client's medical provider told him to RTC if symptoms were not improving. The client reports that he feels they are improving and he is not going  to see his medical provider at this time.
Injection site reaction. There was a sore red raised area where injection was given, and it was itchy.
On 13th day after injection started to have periods of lightheadness, dizziness, and overall tired.  This continued until I passed out on February 8th, hit my head on cement floor due to being atril fibrillation and was taken to hospital.  On February had a heart attack, Acute ST elevation myocardial infarction (STEMI) of inferior wall, and a total of 3 stents put in on that day and the next.
Sore arm; Temp of 100 for 2 days; general aches; fatigue; zero energy; headache on day 3
Instead of getting 0.5ml for the third dose received 0.25; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Instead of getting 0.5ml for the third dose received 0.25) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Instead of getting 0.5ml for the third dose received 0.25). At the time of the report, ACCIDENTAL UNDERDOSE (Instead of getting 0.5ml for the third dose received 0.25) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment drugs were provided.
EXPERIENCING "PHANTOM SHINGLES IN  SCALP AND CHEEK AREA; COMES AND GOES; NOTICED FIRST AROUND OCT 16, PUT OFF GETTING 2ND SHOT THEN RECEIVED 2ND ON 12/11/20.  PRESCRIBED VALTREX ON 12/16/20. PRESCRIBED VALTREX AND GABAPENTIN ON 01/14/21.  HE IS STILL EXPERIENCING TINGLE AND BUMPS THAT ARISE AND THEN DISAPPEAR IN ABOUT AN HOUR.
No reaction until 10 days after vaccine chills feverish legs aching and general fatigue lasting four hours chills with shaking like I'm in an ice box naked....went to dr found nothing No further side; No reaction until 10 days after vaccine chills feverish legs aching and general fatigue lasting four hours chills with shaking like I'm in an ice box naked....went to dr found nothing No further side; No reaction until 10 days after vaccine chills feverish legs aching and general fatigue lasting four hours chills with shaking like I'm in an ice box naked....went to dr found nothing No further side; general fatigue lasting four hours; No reaction until 10 days after vaccine chills feverish legs aching and general fatigue lasting four hours chills with shaking like I'm in an ice box naked....went to dr found nothing No further side; headache; This is a spontaneous report from a contactable consumer (patient).   A 77-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: Unknown), via an unspecified route of administration, administered in left arm as dose 2, single on 12Feb2021 02:00 (at the age of 77-year-old) for covid-19 immunisation. Medical history included heart condition aneurism and leaking valve both from an unknown date and unknown if ongoing. Patient had known allergy to penicillin. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: Unknown), via an unspecified route of administration as dose 1, single on unspecified date (at the age of 77-year-old) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Concomitant medication within 2 weeks of vaccination included losartan potassium taken for an unspecified indication, start and stop date were not reported. On unspecified date in Feb2021 12:00 PM, patient experienced chills, headache, feverish, legs aching and general fatigue lasting four hours chills with shaking like he was in an ice box naked and went to doctor found nothing and had no reaction until 10 days after vaccine. No further side effects until Apr2021 (as reported today) same exact side effects chills with shaking fatigue, legs hurt and slight headache. Adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for adverse event. At the time of this report, the outcome of events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Severe redness, swelling, pain, and rash on trunk and left arm from the injection site (Deltoid) to the elbow.
pt recv vax OCT95 & devel redness, warmth, and/or soreness to the inj site;no tx was necessary;pt recovered;
Extreme joint pain, muscle pain & weakness, causing sleep issues/increased anxiety, inability to work and perform daily functions as previously
Increased pulse, palpitations, 0 SOB noted 1035A B/P - 179/116 P-128. Slow breathing techniques 1035A B/P - 146/97 P-110 1045A B/P - 138/98 P-105 1050A States feel normal v.s. consistent with her norm. Return to work.
CLIENT HAD A TD ON 03/02/2004.  ON MONDAY 03/08/04 MOTHER NOTICED REDNESS IN ARM ABOUT 3 INCHES AROUND AND 1/2 IN RAISED HOT TO TOUCH.  CHILD WENT TO DOCTOR WHO RECOMMENDED NOT TO HAVE ANY FURTHER TD SHOTS IN THE FUTURE UNLESS ABSOLUTELY NECESSARY BECAUSE OF INJURY.  MOM STATES ON TUES. 03/09/2004 THE REDNESS STARTED SUBSIDING. NO RECENT C/O.  PROBLEM RESOLVED.
Right after injection, patient complaints of  metallic taste and scratchy throat. 10 minutes after injection, patient developed mild swelling of lips. VS was stable, a dose of Benadryl 50 mg by mouth given. Patient was taken to ER.
Patient was given Adult dosage of Pfizer COVID vaccine. No adverse reactions seen. Pt had follow up visit 12/21/21
Localized swelling of injection site. No redness, pain, tenderness. Cool compress. No other treatment.  Left injection site.
Bird chirping noise in right ear only and could hear heart beat right ear only; Hair lost; Still having the bird chirpingIn the right ear; This is a spontaneous report received from contactable reporter(s) (Consumer). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Aug2021 as dose 2, single (Lot number: FA7485) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Cancer" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; SIMVASTATIN; FARXIGA nasal. Past drug history included: Codeine, reaction(s): "known allergies: Codeine". Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Batch/lot number: FA7485; Anatomical location: Left arm), administration date: 02Aug2021, for COVID-19 immunisation. The following information was reported: DEAFNESS UNILATERAL (medically significant) with onset 28Aug2021, outcome "unknown", described as "Bird chirping noise in right ear only and could hear heart beat right ear only"; ALOPECIA (non-serious) with onset 28Aug2021, outcome "unknown", described as "Hair lost"; TINNITUS (non-serious) with onset 28Aug2021, outcome "unknown", described as "Still having the bird chirpingIn the right ear". The events "bird chirping noise in right ear only and could hear heart beat right ear only", "hair lost" and "still having the bird chirpingin the right ear" required physician office visit. Therapeutic measures were not taken as a result of deafness unilateral, alopecia, tinnitus.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300199394 Same patient/vaccine, different dose/events (LOE);
Vaccine was reconstituted on the previous day and beyond the recommended 12 hour mark.  Phone call made to Pfizer who supplied studies supporting vaccine continues to be stable up to 24 hours after reconstituting.  Patient was vaccinated just shy of the 24 hour mark.  Patient did not have any adverse effects, this was an administration error.
The patient was administered 0.25ML pfizer pediatric 6 months to 4 years. The vial was mistaken for Moderna 6mo to 5years, so he was given the wrong dose. The dose should have been 0.20ML.
Intestinal inflamation.  Hives and skin rashes face and arm.  Vomiting. Lethargy.  Checked into hospital on 4/16. Inflammation and intestinal thickening.  Pain   Given GERD meds , no help.  Went to Dr and a treatment of 6 days methyl prednisone.   Good for a few days and pain in back nausea.  Lethargy Diahreah.  Would appreciate any help.  Its been 2 months of sickness.  Cant eat .  Dr said no food to get rid of inflammation.   Also, its because my gut was radiated long ago.
Our organization contacted Pfizer, CDC, Poison Control and the Hospital Infectious Disease for recommendations on next steps. The patient was notified of the dosage error the same day and had not had any unusual side effects at that time.
.5ml of H1N1 vaccine was administered to client at 1630. Approximately 1700 client c/o feeling dizzy. Vitals signs were 185/70 HR 60. Client drank 12oz of water and said he felt better.
Arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 28th June 2019, the patient received the 2nd dose of Shingrix. On 28th June 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the patient experienced circumstance or information capable of leading to medication error. On an unknown date, the outcome of the drug dose administration interval too short and circumstance or information capable of leading to medication error were unknown.  Additional details were provided as follows: The age at vaccination was not reported at time of reporting. The age group was not reported but it was selected as adult as per the vaccine indication.  The patient had 1st Shingrix shot on 29th April 2019. The patient reported that when the pharmacy gave the paperwork it said 2nd Shingrix shot was due on 28th June 2019. The patient wanted to know would it be okay if had second shot one day before the exact 2 month mark and if administered might lead to, circumstance or information capable of leading to medication error and shortening of vaccination schedule. The patient asked am still protected.   Follow up information received from the consumer on 22nd July 2019: The patient's demographic details were updated. The patient stated that she did not experienced any side effect apart from arm pain from Shingrix vaccine. Less than a year after vaccination, the patient expereinced arm pain. Previously, captured medication error events (drug dose administration interval too short  and circumstance or information capable of leading to medication error) were deleted since deviation was allowed for Shingrix.  No new details were available. The patient denied permission to contact her physician.
Had vaccine at 5/11 at 2pm.   At 5pm started experiencing dizziness which became progressively worse.    Can barely stand.  If I move head in any direction, I become more dizzy.    If I look up or down, I am likely to fall.  Experiencing minimal nausea.
Sunday morning woke up with chills, as the day progresses chills, fatigue, fever, joint pain, feet numbness, right arm swelling, warmth and could not lift arm up all symptoms lasted around 24 hours
Prior to #1 Moderna Vaccine @ 2/20/2021 Pt. being treated for stress &  hives. Pt. had slight reaction  to vaccine w/ c/o slight right arm x 5 days. 2/27/2020 (7 days later) c/o red, hot, sore, itchy, numb arm (right)
Dose 1, sore injection site for 3 days, left arm, headache for 3 days, a period, heavy bleeding  and cramps for 8 days Dose 2  sore left arm for 1 day headache for 3 days heavy menstruation for 8 days with very bad cramps. Everything stopped but the heavy bleeding and bad cramps. It went off for about 5 days came back o  for 7 days with extremely bad cramps and bleeding went off for about 6 days and now its back on again with very painful cramps and heavy bleeding
headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, the patient experienced HEADACHE (headaches). At the time of the report, HEADACHE (headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported   Reporter did not allow further contact
got the shots and I've got flare ups/suspected vaccination failure; I've got flare ups 2 more time since; 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.   The patient's past medical history included shingles (had shingles).   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 Information: GSK receipt date: 4 Mar 2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the shots and he/she had got flare ups 2 more time since. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Patient is 34-year-old male with complaints of the site of injection swelling.  His last injection was on the 26th of July 2004 and since that time he has had 3 episodes of swelling at the site of the injections.  He reports his most recent injection in July of this year was "normal anthrax swelling".  The swelling lasted for the next few hours but then went away on its own.   The first episode of swelling after this was noticed in September or October of this year.  He reports the swelling lasted for approximately one hours or more.  He reports no known trauma to the area.  No denies any fever or chills.  He brushed up against the door and noticed discomfort and when he looked it was red and swollen.  He reports muscles spasms at the site of injection as well during the time of the redness and swelling.  The spasms lasted for about one hour.  It was kind of like the "little eye twitches but it was in my arm"  It looked similar to how it looks when he gets his anthrax injections.  This episode lasted approximately one hour.   The second episode was in October and he again denies any fevers or chills or any other problems at the time.  This time he reports noticing it when showering.  No illness prior to event.  No trauma to area that he knows of.   The most recent event was four days ago.  He reports feeling something on his shoulder that was approximately the size of a 50 cent piece.   He reports the swelling lasted for 40 minutes and then totally disappeared.  During the time it was red, swollen, and tender and itchy.   No fevers or chills.  "I feel perfectly fine".  Has not been sick
Presented to ED on 1/21/21 with chest tightness and shortness of breath.  Patient reports chest pain with deep inspiration.  Shortness of breath started shortly after receiving vaccine on 1/20/21 and persisted into 1/21/21.  Patient reports no cough, positive lightheadedness with no syncope, positive nausea with no vomiting.  Per exam no fever, no rash, no tongue/mouth swelling.  Emergency Department MD states does not meet threshold for anaphylaxis thus no epinephrine administered.  Patient received Benadryl 50mg IV, Pepcid 20mg IVPB, Solu-Medrol 125mg IV, and 0.9% NaCl 1L IV bolus.
Elderly sent to inpatient Sx Onset: 1/6/2023 Sx: cough fever, profound fatigue - profoundly weak and unable to care for himself at home currently which is why he will be admitted for observation. Bivalent boost 9/2022
The patient received the first dose of pfizer, then waited in the pharmacy waiting room for 15 minutes. Once the patient left and went home the patient caregiver said his eyes, face and lips swelled. Though his breathing was okay. The patients caregiver thinks the patient may be allergic to PEG.
sore arm that became so sore, was hard to lift up at exactly 9 hours after injection. next day arm sore unable to lift up without discomfort migraine type headache, light sensitive, stomach distress
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Rx Number was  The Patient received booster shot of Moderna COVID-19 vaccine