chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My son he was 6 year old had the Pfizer vaccine yesterday; My son he was 6 year old had the Pfizer vaccine yesterday; he was hallucinating; fever but it was an extremely high fever; his fever was 104 degrees; he still has the fever; This is a spontaneous report from a contactable consumer. This consumer reported for 6-year-old male Patient (reporter's son) reported that:  A 6 year old male patient received BNT162B2 (PFIZER BIONTECH COVID VACCINE, solution for injection, Lot: FK5127 ) via unspecified route of administration in arm left (deltoid left) on 05Nov2021 at 17:30 dose number unknown, single for covid 19 immunization. The patient medical history none. The concomitant vaccine within 4 weeks of getting the pfizer vaccine Flucelvax quadrivalent( LOT: 308486, Expiration date: 30Jun2022 (INFLUENZA VACCINE INACT SAG 4V) from 26Oct2021 at 15:00 PM to 26Oct2021 at 15:00 PM for unspecified indication. Reporter stated my son was 6 year old had the Pfizer vaccine yesterday (drug use in unapproved population) and I wanted to report side effect. Reporter further stated yes on friday the day before yesterday at 4 pm. Reporter was informed about the role of Pfizer Drug Safety Department. Reporter stated yes, so the two side effect that, I could knew the first one was, on unspecified date in Nov2021 he did get the fever but it was an extremely high fever, his fever was 104 degrees and that was with the maximum dosage alternating. Tylenol and ibuprofen so, barley keeping it in under control and he was hallucinating. Reporter stated now he still had the fever (further not clarified hence not checked in tab) not the hallucinations anymore. Reporter seriousness for fever but it was an extremely high fever; his fever was 104 degrees; he still has the fever, he was hallucinating: unspecified. Patient received treatment with Ibuprofen (Expiry date: Oct2019) and Tylenol (Expiry date: May2022) to decrease the fever. The patient underwent body temperature measurement test : 104 degree centigrade on Nov2021. The outcome of extremely high fever, hallucinating were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-Up (11Nov2021): Follow-up attempts are completed. No further information is expected.
Patient received the first dose of Shingrix vaccine on Wednesday 5/15/2019. She had a severe allergic reaction that required her to seek medical attention at the hospital. She described the reaction to have occurred over her entire body and looked like something that could only be explained as looking like chickenpox.
About five hours after vaccine was administered, experienced sharp pain/pressure in left eye. The intense discomfort passed after a few minutes, but mild soreness lingered, but I didn?t think much of it. (Thought I had something stuck in my eye.) But a few minutes later, I looked in the mirror and noticed a significant amount of blood in the white of my eye die to a broken blood vessel. I called the on-call staff at my PCP?s office and they recommended a warm compress and a follow-up with urgent care. I saw urgent care today and they confirmed that the blood is localized and unless my vision changes, things should be ok. I?m still experiencing some discomfort, but the blood should reabsorb on its own.  I wanted to report in case this is helpful.
Patient noticed 2 days after injection - her arm started to get inflamed at site of injection. Her arm was red and inflamed, and warm to touch at the site of injection. (Right arm).
Patient had a TIA event at home about 3.5 weeks after 1st Moderna shot, eventually diagnosed at hospital. Stayed overnight 2 nights at hospital. She was approved to get 2nd  Moderna shot. She did so on 2/26/2021. About a month later, she suffered vasovagal episode at home. Not clear if these events are related but doctor suggested we report it.
Patient received vaccine around 10:40am. Husband called pharmacy at 3:10pm to report that wife has been nauseous and throwing up.
2 days p/vax pt devel in inj site rxn characterized by redness & swelling which extended to the elbow;tx w/cold compresses & APAP;pt recovered;
Patient presented to the ED and was subsequently hospitalized for motor vehicle accident, Closed displaced fracture of sixth cervical vertebra, Closed subluxation of spine at C5-C6 level within 6 weeks of receiving covid vaccination.
18jan90 pt vax hepta B. Pt exposed to influenza virus that week.  w/i 2hrs pt developed flushing, esp. on neck, w/ 2inch splotches.  There was no pain or itching.w/i 24-36hrs pt developed n/v/d.  pt recovered w/i 72-96 hrs w/o sequalae.
Pt received a pediatric dose of hep A vaccine, as opposed to the adult dosage. No problem s/s were observed or reported. Pt came received the correct adult dosage Hep A vaccine 11/20/2023.
Initial information received on 22-Jan-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp. This case involves an unknown patient who ended up in the hospital after receiving the vaccine, FLUZONE QUADRIVALENT. 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 dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient was hospitalized for an unknown reason. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for hospitalization. List of documents held by sender: none.; Sender's Comments: Patient was hospitalized for unknown reason after vaccination. However, further information including patient's medical history, concomitant medications, previous vaccination and tolerance, reason for hospitalization,  laboratory investigations excluding any underlying etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
pt recv vax & the evening p/vax 18OCT96 pt exp chills, nausea, fever & malaise;sx resolved w/o treatment;
Patient strongly believe, that patient did not receive the vaccine intramuscularly."Vaccine was given in my arm, but not in to my muscle".; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient strongly believe, that patient did not receive the vaccine intramuscularly."Vaccine was given in my arm, but not in to my muscle".) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient strongly believe, that patient did not receive the vaccine intramuscularly."Vaccine was given in my arm, but not in to my muscle".). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient strongly believe, that patient did not receive the vaccine intramuscularly."Vaccine was given in my arm, but not in to my muscle".) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided No treatment details were provided
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), on 12Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZOLOFT. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 02Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Rebound. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical courses: No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
sick; Initial information received on 14-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who was sick after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, lot number and expiry date was unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event of sick (illness) (latency: unknown) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown
RX Guillain Barre syndrome. Symptom bilateral leg weakness, numbness and tingling in extremities it began on 12/08/2005 is currently being evaluated for rehab. Was unable to ambulate. GBS confirmed in medical record 02/04/06. msv Medical records state hematuria, urinary tract infection, renal failure. msv Patient can walk, but she still has numbness in her arms and legs
Tiny, red, itchy spots on body appeared 1 & 1/2 days after vaccine.  Soreness at injection site reported 1 & 1/2 days after vaccine.
Arm bled after immunization applied pressure, bleeding stopped. Mom called in later to report more bleeding. She applied pressure and it stopped. Mom applied ice pack to the area and elevated the (L) arm. Mom reported child complained of numbness in the arm & swelling & felt like he was going to vomit. Referred pt to Dr.
Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable; No adverse event; Patient administered doses of the vaccine after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient administered doses of the vaccine after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable) and NO ADVERSE EVENT (No adverse event) in a 46-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient administered doses of the vaccine after excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient administered doses of the vaccine after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient administered doses of the vaccine after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable).    Concomitant medications details were not reported by the reporter.  Reportedly, Pharmacist called to discuss a temperature excursion that occurred several days ago in the freezer. the excursion was found out in an audit and all the vaccines were viable.  Treatment details were not reported by the reporter.
A female patient with no reported age and medical history complained of weakness, felt hot, dizzy and achy approximately 3 to 5 hours following the influenza vaccine administration in the right deltoid on 08-Nov-2005. The patient stated, she felt "out of commission" and she complained of left arm numbness that quickly resolved. She developed slight redness in right arm at the injection site. Outcome was not reported. Follow up information received on 27/Jan/2006. The patient recovered. Additional information is not expected.
4-month-old was administered both Pentacel and ActHib at the 2-month appointment with no AE; Initial information received on 17-Dec-2020 regarding an unsolicited valid non-serious case received from a pharmacist in the United States.  This case involves a 4-month-old patient patient who was vaccinated with both Pentacel and ActHib at the 2-month appointment (Product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications were included diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (Pentacel).  On an unknown date, the patient received 0.5 ml dose of suspect HAEMOPHILUS TYPE B (HIB) VACCINE (lot and expiry date unknown via an unknown route for immunization.   It was a case of actual medication error as both Pentacel and ActHib at the 2-month appointment (latency on 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.
Started 2/23/21 with metallic taste in my mouth, next day the metal taste was worse. On 2/25/21 woke with face sagging on right side, slurring, unable to smile.
Pt states that she is experiencing swelling and redness that is also spreading for about a week.
This spontaneous report as received from a registered nurse refers to a 70 year old male patient. Patient's concurrent conditions included hypertension, high cholesterol and degenerative joint disease of neck and back. On 21-OCT-2013 the patient was vaccinated with ZOSTAVAX (lot number: J007210 with expiry date of 20-SEP-2014) (dose, route and frequency unspecified). Concomitant therapies included ZETIA, simvastatin (manufacturer unknown) and losartan potassium (manufacturer unknown). On an unknown date in November 2013 (three weeks after vaccination with ZOSTAVAX), the patient experienced gas like odd smell. The event progressed to total loss of smell. The patient also experienced burning sensation in the throat, tongue and lips along with loss of taste since three weeks after vaccination with ZOSTAVAX. On an unknown date the patient also experienced intermittent rash on face with welts and redness. The patient was treated with prednisone (manufacturer unknown) but was not effective. The patient sought medical attention. The patient was seen by ENT physician with no significant findings. The patient has undergone computerized tomography of brain which was normal. The patient was seen by Neurologist. The Neurologist documented in his report that symptoms were not related to ZOSTAVAX. The patient was referred to Dermatologist and was ordered additional blood work to rule out rheumatoid arthritis. The outcome of events was reported as not recovered/not resolved. The causality of the events with ZOSTAVAX was considered to be not related by the Neurologist. This case is linked to # 1412USA010669 via same patient link. Additional information has been requested.
I received the second dose of the GARDASIL vaccine a year and a few days after I received the first dose, after receiving the injection, about 2 minutes later, I fainted, I hit my head, left cheek, left upper ribs and sternum and left hip bone, everything has resolves besides left upper rib and sternum which are still moderately swollen and it occasionally pops out of place. I have gotten chest x rays and am waiting to hear back. I am concerned that I had an allergic reaction to the vaccination or if my blood sugar was just low that day being it was early morning and I had only a protein bar before that. I have never fainted before so that's why this is concerning to me. I am not sure if I should get the third dose due to hearing horror stories of the serious side effects such as paralysis and weakness, especially after having a reaction to the second dose. Is this a red flag?
Eczema onset after vaccine. None present before shot. Continues to this day with persistent itching to point of breaking skin.
pain/ shooting pain down her arm; injection site pain; Injection site tightness; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 92M54, expiry date 2nd June 2021) for prophylaxis.   Concurrent medical conditions included ehlers-danlos syndrome and connective tissue disorder.   On 16th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 17th April 2019, 1 days after receiving Shingrix, the patient experienced pain in arm, injection site muscle pain and muscle tightness. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the injection site muscle pain and muscle tightness were unknown.   The reporter considered the pain in arm to be related to Shingrix. It was unknown if the reporter considered the injection site muscle pain and muscle tightness to be related to Shingrix.  Additional details were provoded as follows: The patient received the Shingrix in the left deltoid. The day after vaccination, the patient sarted to experience a tightness and pain in the muscle at the site of injection. The patient also had shooting pain down her arm.
6 hours after receiving shot symptoms started. Headache, muscle aches, fatigue, pain at injection site.
Subsequent to receiving the second dose of Engerix B, the pt experienced malaise and nausea which lasted for 24 hours. The most recent information received reports the condition of the pt is resolved.
An infection to right lower eyelid area; This spontaneous case was reported by a Health care professional and describes the occurrence of EYELID INFECTION (An infection to right lower eyelid area) in a forty-five-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jul-2021, the patient experienced EYELID INFECTION (An infection to right lower eyelid area). The patient was treated with VORHYALURONIDASE ALFA (HYLENEX) on 13-Jul-2021 for Adverse event, at an unspecified dose and frequency; CLARITHROMYCIN (BIAXIN) on 13-Jul-2021 for Adverse event, at an unspecified dose and frequency; MINOCYCLINE on 13-Jul-2021 for Adverse event, at an unspecified dose and frequency; CELECOXIB (CELEBREX) on 13-Jul-2021 for Adverse event, at an unspecified dose and frequency and COLCHICINE on 13-Jul-2021 for Adverse event, at an unspecified dose and frequency. On 17-Aug-2021, EYELID INFECTION (An infection to right lower eyelid area) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that the injector did the treatment of 1 mL of Restylane-L lot code 18885 off label to lower eyelids areas on 22 Apr 2021. The patient returned with an infection to right lower eyelid area. Patient had an unspecified vaccine in September 2020 and a routine dental cleaning on 08 Jul 2021.
Rash developed at injection site 3 days after injection (rash is square in shape and 1 1/2" x 1 1/2" in size). Also stated that arm left tingly (same arm as inj). Reported no other adverse events and stated rash is not getting any worse.
I have a severe reaction to the shingle vaccine. I have been told by numerous doctors that it is the preservative in the vaccine that has caused my condition.
Patient presented to the ED and was subsequently hospitalized on 3/8/21. She presented to the ED on 3/13/21. Patient presented to the ED and was subsequently hospitalized on 4/6/21.
Second shot I had fever, chills, hot flashes, and rapid heart beat. Everything has gone away except for the rapid heart beat. It goes high every time I stand up/move around then will go back down once I am sitting/resting. I am calling my doctor this morning for an evaluation.
Body aches (back and legs) Extreme soreness at injection site and upper arm Fever Chills
Case number PHEH2014US022749, is an initial spontaneous report from a health care professional (medical assistant) received on 11 Nov 2014, and with a follow up report received from physician on 16 Dec 2014. This report refers to an 11-year-old female patient. Past medical history and concomitant medications were not reported. Physician reported that the patient had initially received Men A lyophilized component (batch number: unknown) reconstituted with sterile water for injection rather than liquid component of MENVEO. Later on 10 Nov 2014, the patient had received MENVEO (batch number: A14068) powder correctly mixed with liquid conjugate. On the same day she also received ADACEL (batch number: 04955AA, other manufacturer) and GARDASIL (batch number: K006191, other manufacturer) both 0.5 ml intramuscularly. No adverse event was reported. No further information was provided. Follow up report received from physician on 16 Dec 2014. Updated patient demographics, event details.
experiencing temperature of 101; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A child patient received BNT162b2 (BNT162B2), on 02Jul2022 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 immunisation. The following information was reported: PYREXIA (non-serious) with onset Jul2022, outcome "not recovered", described as "experiencing temperature of 101". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Child got the Pfizer Booster (Clarified as Pfizer Covid-19 vaccine) yesterday and is experiencing temperature of 101.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.