chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash at the injection site; red welts; The arm was sore; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site rash, erythema urticarial and pain in arm. On an unknown date, the outcome of the injection site rash, erythema urticarial and pain in arm were recovered/resolved.   It was unknown if the reporter considered the injection site rash, erythema urticarial and pain in arm to be related to Shingrix.  Additional details were provided as follows: A rash at the injection site waspresented a few days after administration of Shingrix that lasted 3-4 days.  It was described as red welts. The patient's arm was sore for a few days also. The reporter did not consent to follow up. This case has been linked with US2020219732 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020219732:same reporter (husband´s case)
Immediate pain at injection site that never got severe, but is still tender 4 days post-vaccine.  Redness at injection site (5 cm 4 days post-vaccine).  Lump at injection site - very hard on date of injection but lessening daily.  I will contact my primary care provider on 2/22/21.
Patient received Pediarix 8 days after the expiration date; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Age at vaccination was not reported. Nurse reported that a patient received Pediarix 8 days after the expiration date, which led to expired vaccine used. No further information reported. The reporter consented to follow up.
accidentally given an expired with FLUBLOK PFS with no reported adverse event; Initial information received on 29-Dec-2021 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who was  accidentally given an expired with flublok PFS (prefilled syringe) with no reported adverse event while receiving vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] via prefilled syringe. . The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a unknown dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (strength, formulation and route : unknown)  (lot QFAA2021;m expiry date: 30-Jun-2021) in unknown administration site for Immunisation.  On an unknown date the patient developed a non-serious accidentally given an expired with flublok pfs with no reported adverse event (expired product administered) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported " Caller stated they had a new employee who was accidentally given an expired dose of FLUBLOK PFS."  Action taken with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK QIV) was not applicable.  It was not reported if the patient received a corrective treatment for the event (accidentally given an expired with FLUBLOK PFS with no reported adverse event).  At time of reporting, the outcome was Unknown for the event accidentally given an expired with flublok PFS with no reported 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 the 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.
This is the 2nd event-(first occurred with my 2nd shot).  Turned over in bed at dawn, a sack of concrete flopped over in my chest, lots of pain, didn't move, went back to sleep, pain was at a point where I was debating  taking Tylenol, didn't dare move, went back to sleep, awoke about noon and the pain was almost gone.  (The first episode lasted 7 full days. and occurred 7 days after the shot).  Today the 8th I feel a little sick but no pain, a dull ache here and there.
not her at all /felt terrible; went for a walk and fell; pain in left arm/ pain radiated to the right arm; Pain radiated to the heart / pain all around heart; very tired / in bed for 2 days; Extreme achiness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Extreme achiness), FEELING ABNORMAL (not her at all /felt terrible), FALL (went for a walk and fell), PAIN IN EXTREMITY (pain in left arm/ pain radiated to the right arm) and CHEST PAIN (Pain radiated to the heart / pain all around heart) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 036C21A, 032M20A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (had COVID before receiving any vaccinations.). Concomitant products included BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET) for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, the patient experienced PAIN (Extreme achiness). 07-Apr-2022, the patient experienced FATIGUE (very tired / in bed for 2 days). On an unknown date, the patient experienced FEELING ABNORMAL (not her at all /felt terrible), FALL (went for a walk and fell), PAIN IN EXTREMITY (pain in left arm/ pain radiated to the right arm) and CHEST PAIN (Pain radiated to the heart / pain all around heart). At the time of the report, PAIN (Extreme achiness), FEELING ABNORMAL (not her at all /felt terrible), FALL (went for a walk and fell), PAIN IN EXTREMITY (pain in left arm/ pain radiated to the right arm), CHEST PAIN (Pain radiated to the heart / pain all around heart) and FATIGUE (very tired / in bed for 2 days) outcome was unknown.            Patient received 1st booster dose on 19Aug2021 and 2nd booster dose on 07Apr2022. Treatment medications were not reported.   This case was linked to MOD-2021-034786, MOD-2022-539364 (Patient Link).
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 27-FEB-2013 the patient was vaccinated with the second dose of GARDASIL (lot # reported as H019495, expiry date reported as 15-AUG-2015). During administration of the dose of GARDASIL, the dose leaked from the tip of the syringe. PQC was filed. Healthcare worker reported that a second GARDASIL syringe was used to complete the vaccination. Healthcare worker reported that this vaccination was the second dose in the GARDASIL immunization series for this patient. No adverse effect was reported. It was unspecified whether the patient sought for medical attention. It was also reported that the product was a prefilled GARDASIL syringe. The outcome was unknown. Additional information has been requested.
c/o arm hurting p/receiving vax 430PM between 8 & 10PM; 22MAY93 states took a hot shower w/water directed @ lt deltoid because cold compresses was irritating; states arm was tender to touch & had little temp; lt deltoid observed to be red
On April 18, 2022, I Licensed Immunized 10 patients with an expired dose of Moderna, which I immediately realized when I filed the documents and stopped the vaccination process. The Covid-19 Vaccine delivery document stated that deadline date and time to use these vaccines was day 6 of month 4 and year 2022 at 7:10am.
Initial unsolicited report received from a Physician via partner company Pfizer (manufacturer reference Number: 2016400975) on 07-FEB-2017. This case involves a female patient (onset age was unknown) who was vaccinated with dose of TETANUS TOXOID (TETANUS TOXOID) (batch number, expiry date, dose and dose in series were not reported) in an unknown site on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed allergic to vaccine which was symptomatized by severe swelling. Laboratory investigations and corrective treatment were not reported. The outcome of events was not reported. List of documents held by sender: none.
being sick; This case was reported by a pharmacist via call center representative and described the occurrence of sickness in a 67-year-old male patient who received HBV (Engerix B) for prophylaxis.   On 8th March 2019, the patient received the 1st dose of Engerix B. On an unknown date, less than 5 months after receiving Engerix B, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Engerix B.  Additional details were reported as follows: The patient was unable to return for the 2nd dose within the recommended time frame due to being sick for a long time. The second dose was administered on 5th August 2019, but caller was inquiring on how to proceed with the 3rd dose? After probing in reference to the sickness, caller stated that he did not have details about the patient's sickness.  The reporter did not consent to follow-up.
Lost all taste and smell; Lost all taste and smell; This is a spontaneous report from a contactable pharmacist, the patient. A 64-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the left arm on 03Mar2021 at 12:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the left arm on 10Feb2021 at 19:15 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. On or about 01Apr2021 at 00:00, the patient lost all taste and smell and as of 22Sep2021, it had not returned. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 18Sep2021, the patient underwent access bio antigen test via nasal swab and the result was negative. The clinical outcome of the events lost all taste and smell was not resolved at the time of this report.
Pt devel hives and injection site warmth, redness, and swelling after being vaccinated with pneumococcal vaccine 23 polyvalent
Second booster of Covid: Terrible accident; Second booster of Covid: Right leg not being right; black and blue marks; Second booster of Covid: Fractured thumb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), 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 (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE; MANUFACTUERER UNKNOWN, First booster), for COVID-19 Immunization. The following information was reported: ACCIDENT (non-serious) with onset 07Apr2022, outcome "unknown", described as "Second booster of Covid: Terrible accident"; HAND FRACTURE (medically significant) with onset Apr2022, outcome "unknown", described as "Second booster of Covid: Fractured thumb"; LIMB DISCOMFORT (non-serious) with onset Apr2022, outcome "unknown", described as "Second booster of Covid: Right leg not being right"; ECCHYMOSIS (non-serious) with onset Apr2022, outcome "unknown", described as "black and blue marks". The clinical course was reported as that the Ibrance and Faslodex are the 2 things keeping her alive. If not for the effect of the second booster of COVID which were all Pfizer, all her medicine has been Pfizer, she wouldn't have been in the terrible accident she had on 07Apr, she is lucky with all the black and blue marks and her right leg not being right, fractured thumb. This Pfizer program situation has her aggravated and anxious every time.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Inadvertently administered an expired Moderna Covid-19 vaccine to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently administered an expired Moderna Covid-19 vaccine to patient) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A, 012M20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 06-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently administered an expired Moderna Covid-19 vaccine to patient). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Inadvertently administered an expired Moderna Covid-19 vaccine to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.
10MAY97 c/o sore arm p/inj given;6hr later red, swollen, hard, warm/hot to touch-size of swelling approx 4" circular area from inj site;11MAY97 lt lymph node in neck visibly swollen;
feel sick; Initial information was received on 23-Oct-2021 regarding an unsolicited valid non-serious case from a Social Media via a consumer/non-health care professional.  This case involves a patient (unknown demographics) who had feel sick (malaise) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a fourth dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious feel sick (malaise) two days following the administration of INFLUENZA VACCINE.  It was reported "I got my fourth (4x) flu shot two days ago, and today I feel sick; Google says that's normal. So why does no one question the flu shots?"  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the event was not resolved.  There will be no information available on the batch number for this case.
About two weeks after the second shot my tongue, roof of my mouth and throat started burning. Some days are better than others but the burning has not gone away,; About two weeks after the second shot my tongue, roof of my mouth and throat started burning. Some days are better than others but the burning has not gone away,; About two weeks after the second shot my tongue, roof of my mouth and throat started burning. Some days are better than others but the burning has not gone away,; This is a spontaneous report from a contactable consumer, the patient. A 81-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6203) via an unspecified route of administration in the left arm on 28Feb2021 at 11:00 (at the age of 81-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism (reported as Thyroid hypo), cholesterol, ocular hypertension, and urinary incontinence. The patient previously took codeine (MANUFACTURER UNKNOWN) for unknown indication on unknown date and experienced drug allergy (reported as Codeine over sensitive). The patient had received other medication (unspecified) within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: El9261) via an unspecified route of administration in the left arm on 06Feb2021 at 12:00 (at the age of 81-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Mar2021 at 12:15, about two weeks after the second shot the patients tongue, roof of her mouth and throat started burning. Some days were better than others but the burning had not gone away. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events about two weeks after the second shot the patients tongue, roof of mouth and throat started burning; some days were better than others but the burning had not gone away, was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Viral Bronchitis (with cough, runny nose, drainage, and chest congestion).  Prescribed Albuterol Sulfate Inhalation Aerosol, 90 mcg.  Consult with physician if symptoms persist to prescribe an antibiotic
Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: Patient's wife communicated that patient was nervous before getting his shot. Shortly after getting shot, he vomited.
tingling and numbness in my right leg/foot 8 weeks post vaccination; tingling and numbness in my right leg/foot 8 weeks post vaccination; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunisation. The following information was reported: HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious), outcome "unknown" and all described as "tingling and numbness in my right leg/foot 8 weeks post vaccination".  Additional information: Patient got both doses of the vaccine. Patient was skinny with no medical history or circulating problems. She have noticed tingling and numbness in her right leg/foot 8 weeks post vaccination. E-transmitting AE. reporter refused to provide any demographics. The line got disconnected as she mentioned the side effects she had post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fatigue; Extremely swollen lymph nodes in neck on side of injection; Joint pain; This is a spontaneous report from a contactable nurse (reported for self). A 33-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 06Jan2021 15:00 at a single dose in the left arm for Covid-19 immunization. The patient's medical history was not reported. The patient had no Covid prior to vaccination. The patient was not pregnant at the time of vaccination. There were no concomitant medications.  The patient had no other vaccine in four weeks and no other medications in two weeks. On 07Jan2021, patient experienced fatigue, extremely swollen lymph nodes in neck on side of injection, and joint pain. The patient did not receive treatment in response to the events reported. The patient was not tested for COVID post vaccination. The events fatigue, extremely swollen lymph nodes in neck on side of injection, and joint pain were reported as not recovered.   Information regarding lot/batch number of the product has been requested.
had a sore shoulder after receiving his first dose of the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 79 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 79 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "had a sore shoulder after receiving his first dose of the vaccine".  Additional Information: The reporter is the patient's wife.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.