chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SHORTNESS OF BREATH; FEVER; NOT FEELING VERY WELL; This spontaneous report received from a pharmacist concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk, expiry: unknown) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 11-MAR-2021, the subject experienced shortness of breath. On 11-MAR-2021, the subject experienced fever. On 11-MAR-2021, the subject experienced not feeling very well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath, fever, and not feeling very well. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Post vaccination syncopal episode about 30 sec, upon arousal vomited several times, color pale, diaphoretic; Medical monitoring  w/vital assessment: BP 98/62 P66 O2 sat 97% RA; rest w/ improvement of symptoms and no additional complaints reported. Released from facility w/ parent-mother.
At home in recliner - reading and IV  stood up and severe dizzeness came on - no warning - Room "Turned around" greatest speed. Closed my eyes. Slowly  walked to bedroom 6 feet away. Had pjs on layed down eyes shut. stay there.
No adverse effects reported; Administered intramuscularly; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.  On 19-NOV-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose and frequency were not reported) (lot # R036582, expiration date 17-DEC-2020, albumin status recombinant Human albumin (rHA)) intramuscularly for prophylaxis (incorrect route of product administration). No adverse effects reported.
This spontaneous report was received from a Licensed Practical Nurse regarding an unspecified number of patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patient was vaccinated with improperly stored, oral, ROTATEQ lot number L008577, and expiration date- 02-DEC-2016 and lot # K015816, expiration date- 29-MAY-2016, (incorrect product storage). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
I put down 2 covid vaccines because there is a discrepancy between which arm I was told at the visit and the lot number the pharmacist wrote on my card (GJ2524)  is different than what is in my profile(Ff2593). I was told I got Covid in the left arm and flu in the right arm.  I believe the Pfizer was in my left since the symptoms I'm having are similar to the first dose I got. Swelling in the armpit, this time I am having added pain in left trap and in left arm as well. Some diarrhea.
FEVER, DIZZINESS, SNEEZING, COUGHING AND NAUSEA
That same night after the vaccine I had low grade fever and body aches and tired. 15 November 2021, I started having a burning and flushing sensation on my face, my face was pinker than usual, on and off.  Saw doctor at walk in clinic 23 November, they couldn't find anything wrong and my I saw my own doctor on 1 December 2021.
This spontaneous report as received from a pharmacy technician concerning a currently 26 years old patient. Gender was not reported. Medical history and concurrent conditions were not reported. On 16-APR-2014, the patient was vaccinated with VARIVAX (Merck) lot # J003700; expiration date: 27-MAR-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
maternal vaccine exposure with no reported adverse event; Initial information received on 09-Dec-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 34 years old female patient who was exposed to vaccine Diphtheria-2/Tetanus/5 AC pertussis vaccine [ADACEL] in context of maternal vaccine exposure with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported maternal vaccine exposure with no reported adverse event occurred at 17 weeks of pregnancy and the patient was exposed to Diphtheria-2/Tetanus/5 AC Pertussis vaccine at 17 weeks of pregnancy, during second pregnancy trimester for Diphtheria-2/tetanus/5 AC pertussis vaccine.  The date of last menstrual period was reported as 20-May-2022.  The estimated due date is 23-Feb-2023.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had unknown previous pregnancy/ies.   On 12-Sep-2022, the patient received a dose (dose number 1) of suspect Diphtheria-2/Tetanus/5 AC Pertussis vaccine Suspension for injection; lot U7549AA (strength, dose, frequency and expiry date: not reported) via intramuscular route in unknown administration site as prophylactic vaccination (Immunisation).  On 12-Sep-2022, the patient developed a non-serious event of maternal vaccine exposure with no reported adverse event (exposure during pregnancy) following the administration of diphtheria-2/tetanus/5 AC pertussis vaccine.  No lab data was reported.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (maternal vaccine exposure with no reported adverse event).  At time of reporting, the outcome was Unknown for the event maternal vaccine exposure with no reported adverse event.  Additionally, at time of reporting, the pregnancy is still ongoing.
Soreness and aching of the arm that received the injection, with warmth and tenderness at the injection site. Slight fatigue since receiving first dose.
Arm and shoulder pain, redness, burning, and bulging at site of injection that keeps growing larger the longer time passes. 2 months since vaccine with same symptoms. Tissue will be surgically removed under general anesthesia on 07/27/2021.
2nd dose given two weeks after 1st dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 6-year-old female patient who received HBV (Engerix B) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On 22-MAR-2023, the patient received the 2nd dose of Engerix B. On 22-MAR-2023, an unknown time after receiving Engerix B and an unknown time after receiving ENGERIX B, the patient experienced drug dose administration interval too short (Verbatim: 2nd dose given two weeks after 1st dose). The outcome of the drug dose administration interval too short 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 Information: GSK Receipt Date: 23-MAR-2023 Lot number and expiration date were asked but declined. The reporter consented to follow up via email. The patient received 2nd dose of Engerix B, earlier than the recommended interval, which led to shortening of vaccination schedule.
Patient reported having a "severe reaction" 5-6 days post injection of 1st dose of Moderna vaccine, consisting of severe headache and irretractable vomiting.  This lasted for 24 hours.
A week after the  first shot the are swelled and have a red rash  and itchy  under the ejection site and a red dot at the site.  Became tired and achy.
Pt received 3rd GARDASIL vaccine and had an allergic reaction (neck was blotchy red & pt was itching all over) 24hrs later. Pt had no problems w/1st and 2nd vaccine.
Fever, chills, malaise, myalgias. No treatment. Symptoms resolved approx 24 hours after onset.
At onset, only general malaise, some soreness at location of IM vaccine.  Malaise continued throughout the day, becoming more significant over time. By 4:30PM, very low energy, continued malaise. 8:30PM, weariness, weakness, causing patient to need to lie down. 9:00PM violent shivering. Patient did not appear to have elevated temperature. 12:00AM substantial headache which continued throughout the night. Patient took 200mg ibuprofen at 8:00AM and was able to sleep 3 hours. Soreness, headache, low energy, and general malaise continued through 10/27/2013.  Low or no appetite throughout.  Probably 80 hours of continuous symptoms, mostly spent lying down or sitting quietly.
325PM epi 1:1000 recvd  RAT as instructed by MD for tx of hives developing p/immun were given; recommended to parents to follow up w/DPH;
Pt was given Moderna for the 1st dose of Covid vaccine.  Pt came in for the 2nd dose during a Vaccination clinic that was for Pfizer patients only.  It was given by another nurse, before I got to his paperwork.  When I discovered he had the Moderna vaccine for the first dose and was given Pfizer vaccine for the 2nd dose.  Pt was notified of the error.  Pt was followed up with by his primary provider NP.  Pt did not have any adverse reactions due to receiving different vaccines.  The follow up research indicated that not to give another dose of Moderna.  The Administrator for the clinic was notified of the medication error.  Provider was already notified by the patient and it was discussed in the medical staff meeting the next Monday.  Subsequently, the patient was not harmed.  We now double check every patient coming through the door of which vaccine they received first during a vaccination clinic. RN
Patient hospitalized despite having received the Pfizer vaccination.  Patient unable to provide the dates for vaccine administration.
pt recvd vax 22OCT94; 6 days later devel red inflammed hands & wrist eventually spread to lower trunk & legs; given topical hydrocortisone & cold compresses;
Weakness,  chills, nausea and excruciating stubbing pain in L shoulder with even minor movement
The day after I received the vaccine my arm swelled up, I had chest pains. I went to my doctor we thought I may have been having an allergic reaction and anxiety because of that. He advised me to take Benadryl to help. The chest pains kept up and I started wearing a watch that helps to monitor heart rate. In January my heart monitor indicated that heart rate dropped to 72, I went to the emergency room. My anxiety kicked in so by the time I did get seen my heart rate was back to normal. My doctor has put me on a regimen of baby aspirin, it took three months for my chest pains to lessen.
The right side of my face started to become numb within the first 2-3 hours after receiving the Pfizer booster shot.  It continued to get worse and two days later, after seeking medical advice, I was diagnosed with Bell's Palsy.
"swollen upper lip and roof of mouth started to feel like roof of my mouth was starting to thicken"  started 1 hour after injection and lasted for about 45 minutes.  Then no further symptoms
She wanted to know if Paxlovid could be used very soon after the vaccination with the Pfizer-BioNTech COVID-19 Vaccine, Bivalent gray cap; She wanted to know if Paxlovid could be used very soon after the vaccination with the Pfizer-BioNTech COVID-19 Vaccine, Bivalent gray cap; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 26-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She wanted to know if Paxlovid could be used very soon after the vaccination with the Pfizer-BioNTech COVID-19 Vaccine, Bivalent gray cap".Caller on behalf of a 26-year-old female patient. She wanted to know if Paxlovid could be used very soon after the vaccination with the Pfizer-BioNTech COVID-19 Vaccine, Bivalent gray cap.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Breakthrough case admission after 3 vaccines Moderna 2/25/21 Lot# 031L20A;  Moderna 3/25/21 Lot# 045A21A;  Moderna 11/6/21 Lot# 939906;
Patient was 17 years old at time of vaccination, which is outside of the approved age range for the Moderna vaccine. Patient did not experience any known adverse reactions to the vaccine.
Patient presented to ED with severe polyuria, polydipsia and worsening hypoxia. Newly diagnosed diabetic with symptoms of DKA for approximately 9 days. Patient fully vaccinated with Pfizer on 8/6/21 and 8/30/21. Patient admitted with DKA and COVID pneumonia on 11/9/21.
STARTED TO EXPERIENCE CONSTANT DIARRHEA WHICH LASTED UNTIL 10/10/2016.
R thigh firm nodule approx 3x3cm 1x1cm area red no tx instructed parent to apply warm compresses to site.
Covid-19 Vaccine EUA  On 03/04/2021 a red hard swelling about 3 " in diameter appeared close to injection site.  It was hot and sore. It dissapated in app.6 days.
After shots were given, pt transferred from examination table to a nearby chair when she started to feel lightheaded.  No LOC.  Pt was observed to be pale.  Vitals were taken with BP dropped from 119/76 to 95/65, pulse from 88 to 64.  Blood glucose 140.  No other associated symptoms including dyspnea, headaches, swelling or rash.  Pt was given some water.  Pt remained resting in chair and over the course of 15 minutes, regained color to her skin and report of dizziness resolving.  Pt was discharged home with mother with closed monitoring.  ER precautions signs given to mother.
diluted dose due to inappropriate reconstitution; diluted dose due to inappropriate reconstitution; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 14-months-old female patient who received Hib (Hiberix) (batch number 7325S, expiry date unknown) for prophylaxis.   Previously administered products included Hiberix (received 3 doses on an unknown date).   On 7th December 2021, the patient received the 4th dose of Hiberix. On 7th December 2021, unknown after receiving Hiberix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 21-JUN-2022 Reporter's comment: The nurse reported that a patient received a diluted dose of the Hiberix vaccine due to inappropriate reconstitution. The reporter was consented to follow up. Additional Supportive Information: The patient was administered diluted dose of the Hiberix vaccine due to inappropriate reconstitution, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case is one of 3 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022095743:Same reporter
friend and he had the same thing with the oral mouth ulcers occur.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MOUTH ULCERATION (non-serious), outcome "unknown", described as "friend and he had the same thing with the oral mouth ulcers occur."  Additional information: NDC number, batch/lot number and expiry date was not provided. Other products was not provided. Patient history not provided. Investigation assessment was not provided  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Died due to the fact he received the Covid shot; Tested Positive for Covid after Vaccine; Tested Positive for Covid after Vaccine; This is a spontaneous report from a contactable consumer (patient's friend). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The consumer stated she knew that a friend (the patient) died due to the fact he received the Covid shot. The consumer stated all of the patient's body and organs were spiked with proteins, and they were elevated from Covid. The patient was tested Positive for Covid after Vaccine on an unspecified date. The patient died on an unspecified date.  It was not reported if an autopsy was performed. The outcome of the event tested Positive for Covid was unknown.  The lot number for [bnt162b2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: died due to the fact he received the Covid shot
Patient was called about the new Bivalent vaccine and will  get that in 2 months.
Chills; headache; This is a spontaneous report from a contactable consumer. A 27-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 16Feb2021 at 08:30 (Batch/Lot Number: EL3247) at 27-years-old as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine. The patient did not have COVID prior to the vaccination. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunization on 27Jan2021 (Lot number: EL3247, Administration time: 08:30, Vaccine location: Left arm, Dose number: 1). On 16Feb2021 at 20:00, the patient experienced chills (non-serious) for 24 hours, and headache for 72 hours; with no treatment received.  The clinical outcome of the events was recovered on unspecified dates. The patient was not tested for COVID post vaccination.
dizziness; fever 100; chills; body aches; nausea; fatigue; pain at injection site; swelling in neck; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunisation. The following information was reported: PAIN (non-serious) with onset 23May2022, outcome "recovered" (2022), described as "body aches"; CHILLS (non-serious) with onset 23May2022, outcome "recovered" (2022); DIZZINESS (non-serious) with onset 23May2022, outcome "recovered" (2022); FATIGUE (non-serious) with onset 23May2022, outcome "recovered" (2022); PYREXIA (non-serious) with onset 23May2022, outcome "recovered" (2022), described as "fever 100"; HEADACHE (non-serious) with onset 23May2022, outcome "recovered" (2022); NAUSEA (non-serious) with onset 23May2022, outcome "recovered" (2022); VACCINATION SITE PAIN (non-serious) with onset 23May2022, outcome "recovered" (2022), described as "pain at injection site"; SWELLING (non-serious) with onset 23May2022, outcome "recovered" (2022), described as "swelling in neck". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, pyrexia, chills, pain, nausea, fatigue, vaccination site pain, swelling, headache.  Additional information: It was reported that patient did not receive any vaccine and any other medication in 2weeks. The patient had no other medical history and no known allergies. The events did not result in emergency room, physician office visit or intensive care unit. The patient experienced these side effects from her second booster.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Continual involuntary twitching of chin area & one leg; never twitched like this before
57 year old patient received the FLUZONE HIGH-DOSE QIV vaccine, with no reported adverse event; Initial information received on 20-Jan-2023 regarding an unsolicited valid non-serious case received from a Non-Healthcare Professional.  This case involves a 57-year-old female patient who received the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Diabetes mellitus and Hypertension, but not immunocompromised.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for Immunisation.  On 20-Jan-2023, the patient received 0.7ml total dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation: unknown) (lot number: UJ9330AA and expiry date: 30-Jun-2023) via intramuscular route in the right deltoid for Immunization and a 57-year-old patient received the fluzone high-dose qiv vaccine, with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  It was reported, the caller is requesting recommendations and further guidance and requesting validity and safety information.   Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  At time of reporting, the outcome was Unknown.  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.
Severe mid Epigastric pain, vomiting, wt loss. Diagnosed with H. pylori gastritis. Symptoms started 7/1/16, Diagnosed 8/5/16.
Immediately after receiving her vaccination, she reported feeling lightheaded. She was taken to a private section of the arena and monitored.
strange feeling back of left thigh starting  on 9/10/21 @ 1015am traveled to calf.  called PCP office, they instructed patient to go to ER for US to rule out blood clot.  patient arrived with Full Code Stroke symptoms @ 12:45pm with left side paralysis.  administered tPA within time window. residual VITT symptons.