chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Student dropped off at Mall. At 5:30pm student called mother with Sx of SOB, grey lips, perspiration, pale skin color, numbness of legs, slurred speech. Injection site warm only. States Sx moved from head to toe. Mother took student to Urgent Care. Mother told to give BENADRYL and ibuprofen by Urgent Care MD. Student continues to have flu-like symptoms with fever on 2/27/09.
No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-APR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T021639, expiration date: 21-DEC-2021, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
- Men B #1 6/29/2021 1pm Called at 4pm due to vomiting & shaking. ER eval 6/29 at 10:20pm - vomiting 8-10 episodes, temp 39.4, p129 BP 97/58 sat 97%  ER return 7/2/21 with pleurisy - admitted with LLL pneumonia with effusion
Arm swollen and red went to urgent care given BENADRYL and KEFLEX.
Pt. remembers significant bleeding at time of injection into deltoid muscle and subsequent bruising. On current date, 10/19/15, patient has pain radiating down the arm to the hand with pins and needle sensation in the thumb and index fingers. Observed small bruise still visible on deltoid muscle.
Since the vaccination, has the patient been tested for COVID-19?:Yes; Since the vaccination, has the patient been tested for COVID-19?:Yes; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date Apr2021 (Batch/Lot number: unknown) at the age of 46 years as dose 2, single and intramuscular, administered in arm left, administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "positive epstein barr virus" (unspecified if ongoing). There were no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination.  There were no concomitant medications. There was no other vaccine in four weeks prior to the COVID vaccine. There were no other medications in the 2 weeks of vaccination.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Dec2021, outcome "unknown" and all described as "Since the vaccination, has the patient been tested for COVID-19?:Yes". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.        known allergies: No; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of COVID-19 test positive and drug ineffective due to temporal relationship.  Case will be re-assessed upon the additional information provided.
Patient reports cold sweats, dizziness, nausea, almost passed out, pain at injection site, body aches/shiver
Pt recvd DTP/OPV/HIB 8JUN92 & APAP was given for fever; MD recvd a call on 9JUN92 that pt died @ 7AM; Called ME @ 315 on 9JUN92 pt was sleeping w/mom & grandma found pt dead;
This case was reported by a healthcare professional and described the occurrence of bumps around injection site in a 30-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included FLUZONE (Sanofi) given in the right arm on 3 March 2012. Concurrent medications included PERCOCET and MOTRIN. On 3 March 2012 at 14:43, two days post normal delivery of a newborn, the subject received a dose of BOOSTRIX in the left arm. On 3 March 2012, 47 minutes after vaccination with BOOSTRIX, the subject experienced bumps around injection site and injection site redness as well as injection site hives. The subject was treated with BENADRYL. On 3 March 2012, 63 minutes following event onset, the events were resolved. The healthcare professional considered the events were possibly related to vaccination with BOOSTRIX. Based on the subject's reaction, it was noted that she would not receive further vaccinations with BOOSTRIX. Follow up information received from the subject's pharmacist on 11 June 2012. The pharmacist reported that the subject received BOOSTRIX 0.5 ml dose. She noted that BOOSTRIX ("Tdap") was the suspect vaccine and that she did not consider the events serious. The pharmacist marked that no action was taken with the BOOSTRIX and that immunization series was discontinued. The pharmacist confirmed that the events were started and resolved on 03 March 2012.
PHLEGM; This spontaneous report received from a consumer 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: Unknown) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the subject experienced phlegm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of phlegm was not reported. This report was non-serious.
Transient hemi-anesthesia A follow up report received 01/22/2003 adds: It was reported that a female pt was given a post exposure series of Imovax Rabies for bat exposure. Pt experienced "flu-like" symptoms after 2nd and 3rd doses. On 02/18/2001 the pt developed numbness in left side of face, ear, arm and calf, no sensory perception in left side, now in right side. Was seen in ER on 02/18/2001, CAT scan done. Referred to neurologist and ENT doctor, MRI done, all reports sent to primary care physician. Unresolved, getting worse. Per Aventis Pasteur Inc. Medical Safety Officer's conversation with primary care physician on 02/28/2001, it was stated that the neurologist evaluated the pt and made a diagnosis of hemianesthesia. From additional correspondence received on 05/07/2001, additional laboratory data was provided. From follow-up #1 mailed correspondence received on 06/12/2001 stated, "Reviewed, nothing to add at this time. This case is closed.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Nov2022 as dose 5 (booster), single (Lot number: GLO446) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "EPI" (unspecified if ongoing), notes: Exocrine pancreatic insufficiency. Concomitant medication(s) included: METFORMIN; CREON. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Report about covid treatment was reported as yes. Reporter type patient, If vaccine received was reported as yes. Other medication in 2weeks was reported as yes. Patient received Paxlovid treatment from 03Jan2023 to 07Jan2023 for Covid-19.
pt recvd flu vax & the following day, pt devel soreness & edema in the area of the inject site, which lasted for 12 days; also had gastrointestinal upset & diarrhea;
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  It was reported that patient's facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger that caller was unable to download were for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter also stated that no adverse reactions were reported by any patients.  Treatment information was not provided.
Fever, chills, body ache, nausea, tiredness, dizziness, rash and pain at injection site.
expired dose of the daptacel single-dose vial was inadvertently administered with no reported adverse event; Initial information received on 20-Apr-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old male patient who experienced had dose of the daptacel single-dose vial was inadvertently administered with no reported adverse event after receiving vaccine diphtheria-15/tetanus/5 ac pertussis vaccine [daptacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hib vaccine conj (tet tox) (hiberix) for Prophylactic vaccination.  On 20-Apr-2023, the patient received a dose 4  0.5 ml of suspect diphtheria-15/tetanus/5 ac pertussis vaccine Suspension for injection, lot C5828AA via intramuscular route in the left thigh for Prophylactic vaccination (Immunisation).  On 20-APR-2023 the patient developed a non-serious event expired dose of the daptacel single-dose vial was inadvertently administered with no reported adverse event (expired product administered) (latency: same day).  Lab data was not reported.  Action taken was not applicable.  Outcome: Unknown for the event expired dose of the daptacel single-dose vial was inadvertently administered 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 guidelines. 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.
Immediately after hyperventilation, numbness of arms and scalp, dizziness, elevated pulse. Within 15 minutes developed headache and rash on face as well as nausea. Mostly recovered within 90 minutes but had nausea, fever signs (hot,cold, sweating,etc) and excessive thirst for next 4 days.
NSTEMI with 99% occlusion of LAD, First ER visit 5/1/21 with reports of 2 days of throat tightness, Second ER visit 5/7/2021 NSTEMI via cardiac cath lab with stent placement.  Had cardiac cath 10/2020 at hospital in with no abnormal findings
pt recvd vax;devel fever of 102 & malaise;lab testing indicated SGOT 119, SGPT 158 & LDH elev;hep A,B,C neg;seen by MD on 7jul95;at time of rpt, liver enzymes nl except LDH which remained elev;
At approximately 1420, the patient did not receive the full dose (0.3 mL) of Bivalent Pfizer Booster COVID-19 Vaccine (Lot# GJ5342); when a nurse started to push the syringe plunger into the client's right deltoid muscle, vaccine leaked out from the needle hub and the syringe luer lock, and more than 3 drops spilled out of the syringe and onto the patient's arm. Docter recommended that since the patient had not received the full dose (0.3 mL) of the Bivalent Pfizer Booster COVID-19 Vaccine, administration of the vaccine should be repeated upon the patient's request. The patient agreed to repeat administration. At 1450, the patient received Bivalent Pfizer Booster COVID-19 Vaccine (Lot# GJ5342, expiration date) in her left deltoid muscle,
RECEIVED 2.5ML OF THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 39 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, and expiry: 07-MAR-2022) dose was not reported, administered on 21-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-NOV-2021, the patient experienced received 2.5ml of the janssen covid-19 vaccine. On 21-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious.
Pt's mom report swelling, redness and bruising on both upper arms at injection sites, developed approximately 12 hours after imm given. Now approx. 4 1/2cm erythema with induration and bruise L upper arm, 2cm on R arm with erythema.
Approx. 1-2 hours, post vax, the pt was reported to break out in hives with severe itching. He called his MD and was given a prescription for Benadryl.
no adverse event; Product storage error; This spontaneous report has been received from a nurse referring a 5-year-old female patient.  The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 24-MAR-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot number U025790, expiration date: 19-AUG-2023, administered subcutaneously as prophylaxis (strength, dose and anatomical location were not provided) (product storage error). The temperature excursion occurred between -14 degrees Celsius up to -10 degrees Celsius for 3 hours and between -10 degrees Celsius up to 8 degrees Celsius for 1 hour and 30 minutes. It was reported that a data logger was involved. No previous temperature excursion were reported. It was stated that the event was attributable to a device or device component malfunction, however there was no device involved.  No additional adverse events were reported; Sender's Comments:  US-009507513-2205USA008004:
having headaches after getting the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) 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: HEADACHE (non-serious), outcome "unknown", described as "having headaches after getting the vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The base of my tongue started swelling about 10 min after receiving the shot and within 20 minutes my throat began to swell and I was rushed to the emergency room. I received and epi injection and then an oral dose of a combination of Benadryl and steroids.
This spontaneous report was received from a licensed practical nurse, referring to multiple unspecified patients of unknown age and gender.  Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored ROTATEQ (lot # M014544 expiration date: 27-NOV-2017 and lot # M040269 expiration date: 28-APR-2018). The vaccines were exposed to 32 to 35 Fahrenheit degree for 2 hours. No previous excursions. A data logger was used. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA004034: US-009507513-1704USA004041: US-009507513-1704USA004042:
itching and puffiness in her eyes; itching and puffiness in her eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 91 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Aug2021 17:30 (Batch/Lot number: unknown) at the age of 91 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "bladder disorder" (ongoing). Concomitant medication(s) included: PREMARIN taken for bladder disorder (ongoing). Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 06Jan2021, when the patient was 90 years old, for Covid-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), administration date: 20Jan2021, when the patient was 90 years old, for Covid-19 immunisation. The following information was reported: EYE PRURITUS (non-serious), PERIORBITAL SWELLING (non-serious) all with onset 2021, outcome "recovering" and all described as "itching and puffiness in her eyes".  Additional information: It is reported that the patient had the third dose of the COVID vaccine. She has experienced the events since. Also, her daughter in law had third dose as well, and experienced itching in both eyes. She doesn't want to get her daughter in law involved Her daughter in lase initials are withheld. The caller confirmed the details provided by the transferring agent. She doesn't want to do a report for her daughter in law. The caller got her third dose at (pharmacy name), but she doesn't know the address. The itching started after the vaccine. The itching started first, and then her eyes got a little puffy. He injection was at 530pm on 18Aug2021. Her eyes are still slightly puffy. She started putting ice on her eyes on Saturday, 21Aug2021. Her daughter in law's eyes were just itchy the day after. Her daughter in law read to put ice on the eyes. Her daughter in law iced her eyes as well. The third vaccine was given in her left arm. She got her first COVID vaccine on 06Jan2021, and two weeks later she got the second one. She knows she got one of those in her left arm, and the other in her right. Her card is too tiny to read the information so she cannot provide NDC/lot/expiration for any of the doses. The first two were a drive through thing. She was sitting in the car. The caller's puffiness is almost gone. Her daughter in law got the icing information from the internet because other people had the problem. No details on the other people provided. Prior vaccinations (within 4 weeks), patient's medical history (including any illness at time of vaccination) and relevant tests were not provided. Investigation Assessment was reported as no.  Follow-up (04Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
I was preparing for a colonoscopy on 01/08/2023. I mixed a batch of the solution for the procedure, irritated my throat. I had the procedure on the 01/09/2023. By the 10th, my throat hurt worse, I had a bad cough and pain. On 01/11/2023, I had taken a COVID-19 test and, I was positive. The next day I contacted my doctor and was prescribed PAXLOVID. The sore throat was gone on the 2nd day of the medicine. My symptoms were gone, but I was still testing positive until the 28th. I have been well ever since.
Pt relates adverse reactions of malaise and myalgia with GI effects of nausea and vomiting after injection #1 on 10/15/09.
PATIENT SAID SHE HAD HER LEFT SIDE OF FACE SWOLLEN ON 10/13/20  AT 12 PM, THEN SHE HAD HIVES ON HER BODY ON 10/14/20 AT 7 AM , THEN HER LIPS WERE SWOLLEN ON 10/15/20 AT 6 PM
It was reported that a patient (4 of 6) received a Fluzone SV 2001-2002 vaccination (administration date and site information was not provided). Sometime after the vaccination (exact date not specified) the patient developed a local reaction at the injection site. Further information is requested. Linked cases: U200101055, U200101225, U200101226, U200101228, and U200101229.
pt recvd vax & legs hurting & fever t103 ax; taken to MD-cold sx & sinus infect; tx Septra; taken to MD 5MAy c/o fever
This spontaneous report has been received from a currently 74 years old female patient reporting on herself, patient with asthma and unspecified allergic condition. Information regarding medical history, and concomitant therapies was not provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23, intravenously (strength, dose, frequency, anatomical location, lot# and expiration date were not provided) for prophylaxis. On an unknown date, within 24 hours of the vaccination, the patient experienced "excruciating pain in her arm", after removed her shirt she noticed that her arm "was swollen about 50% larger than normal and also she had a "big welt on her arm that turned white". Therefore she contacted her physician and went back for a check up, the physician was given BENADRYL and unspecified OTC medicine to help the pain subside. Several days after, the patient began experiencing "muscle or joint pain" in her arms legs and buttocks, as result of she returned to saw the physician once again, and unspecified test were performed to see what was causing the persistent body aching, however her physician was not able to located any findings from these tests. At the time of the reporting the patient continued with the treatment and the outcome of pain in her arm, muscle or joint was recovering, and the outcome of swollen arm and big welt on her arm was reported as unknown. The reporter considered pain in extremity, arthralgia and myalgia to be related to PNEUMOVAX 23. Additional information is not expected since the reporter did not consent for follow-up attempts.