chrisvoncsefalvay/vaers-outcomes huggingface dataset:
inadvertently administered Bexsero instead; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old male patient who received Men B NVS (Bexsero) (batch number 59M3M, expiry date 28th February 2023) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th July 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 25th July 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered 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: 25-JUL-2022 Reporter's Comment: The reporter reported that, administration of Bexsero at the time of reporting for patient accidentally and their office usually administers 1st dose of Bexsero at age 16 years old.  She reported that, they were intending to administered Boostrix and inadvertently administered Bexsero instead of Boostrix.  The reporter reported that, Boostrix was administered at the same visit. The reporter consented to follow up. Additional Supportive Information: The reporter reported that, they were intending to administered Boostrix and inadvertently administered Bexsero instead of Boostrix, which led to wrong vaccine administered.
Patient knowingly presented to clinic in on 8-4-21 for the Janssen vaccine after having received the Pfizer shots in on 2-19-21 and 3-12-21.
Covid - symptoms started mid august . got test was negative and sample molecular test and it was positive. Attack of diverticular occurrence
I developed a rash around my mouth on the 29th. It was an orange ring around mouth. It had some peeling. It was kind of like a sunburn it was dry and rough. Dermatologist gave me a cream that I only used once. I stopped using it because I felt like it made the rash worse. I used Vaseline instead. I stopped using chap stick. The rash didn't itch but it did tingle like an annoying feeling. I developed a bubble blister underneath skin at the injection site.
Fever, chills, fatigue. muscle and joint pain (especially in legs) and pain at injection site .  Goes away with Excedrine but comes back after wearing off.  Not sever enough for urgent care.  Pretty sure this is a reaction to the Shingles vaccine.
Left arm fatigued, sore, still painful after over a week. Pain radiates down arm. Issue is not getting worse just staying the same.
headache / little headache; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 24Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, after receiving the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine, he had a headache/ little headache on 25Feb2021. He wants to know if he can take Ibuprofen/Aspirin to treat this. He also wants to know how long he had to wait to take these medications as was advised before not to take it. The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
itching; rash size of 1"x2", grew to 3"x5" couple days later; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash size of 1"x2", grew to 3"x5" couple days later) and PRURITUS (itching) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LEVOTHYROXINE SODIUM (THYROXINE) and ESTRADIOL for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced RASH (rash size of 1"x2", grew to 3"x5" couple days later). On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH (rash size of 1"x2", grew to 3"x5" couple days later) and PRURITUS (itching) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       This case was linked to MOD21-022477 (E2B Linked Report). This case was linked to MOD-2021-037858 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jan-2021: Customer provided additional information, date of birth, vaccine lot number, event specifics and treatment information; Sender's Comments:  MOD21-022477:same reporter, additional info added for dose 1
Tingling sensation in throat 5 minutes after vaccine to 45 minutes after. Sensation didn't decrease. Went back to work at unit. Has history of anaphylaxis to certain medications and ADR to TDaP
This initial report was received from a registered nurse referring to a patient of an unknown age. Concurrent conditions were not reported. On 26-JUN-2015, the patient received an improperly stored dose with PROQUAD (Merck), (Lot # 008354, expiration date 9-NOV-2016), (dose and route were not reported). No adverse symptoms were reported. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's medical history was not provided. Her concurrent conditions included hypertension and an unspecified blood clotting issue. Concomitant therapies included warfarin and an unspecified blood pressure medication. None known drug reactions/allergies were reported. On 13-FEB-2017, the patient was vaccinated with a dose of ZOSTAVAX (subcutaneously on the lower arm between the elbow and wrist, lot # M027348, expiration date 27-JUL-2017; dose was not reported) for prevention of shingles. In February 2017, the patient experienced some irritation on the skin. Due to this, the patient saw her primary care physician. None lab diagnostic studies were performed. The outcome of skin irritation was unknown. The relatedness between the adverse event and ZOSTAVAX was not provided. Additional information has been requested.
Autism and loss of speech. (The pt is a twin.) Follow up on 07/15/04 states: "Vaccine recipient has not recovered from adverse events. Residual symptoms: Mental and physical disability."
Fatigue lasting 24 hours Headache lasting 24 hours Loss of appetite lasting 12 hours Chills lasting 3 hours
Needle leaked during administration; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number j39g3, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th October 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 11th October 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered 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: 11-Oct-2022 Reporter's comment:  The pharmacist reported that the patient was administrated with Flulaval QIV and the needle was leaked.  Adverse event was not reported. The pharmacist thought it was because of a problem with the needle gauge.  They were using 25g instead of 21g and 23Gg. The patient's identifiers was not provided The reporter consented to follow up. This case had been linked with, US2022146208, reported by same reporter, Additional Supportive Information: The patient was administrated with Flulaval QIV and the needle was leaked, which led to incomplete dose administered.; Sender's Comments:  US-GSK-US2022146208:Same reporter
Initial case was received on 09 June 2010 from a healthcare professional. A 12 year old female patient received an intramuscular injection of ADACEL (lot number C2937AA) on 02 August 2008. The patient's medical history and concomitant medications were not reported. It was unknown by the reporter if any other vaccinations were given within 4 weeks of the ADACEL vaccination. On 03 June 2010 at 13 years of age, the patient had a positive test for Bordetella pertussis via direct fluorescent antibody (DFA). As of this report the outcome is unknown. Documents held by sender: None.
expired dose of DAPTACEL was given to a patient ; practice discovered that the Daptacel that was administered had expired ( with no reported adverse event); Initial information received on 01-Apr-2022 along with live follow-up regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves 10 years old male patient for whom expired dose of daptacel was given to a patient ; practice discovered that the daptacel that was administered had expired ( with no reported adverse event) while receiving vaccine Diphtheria-15/Tetanus/5 AC Pertussis Vaccine [Daptacel].  The patient's past medical history, medical treatment(s), and family history were not provided. Patient received no concomitant vaccines. At the time of the event, the patient had ongoing Diabetes.   On an unknown date, the patient received 5 doses of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via intramuscular route. On 31-Mar-2022 he also received a Booster dose of the same vaccine  (lot C5706EA; expiry date: 11 Mar 2022) via intramuscular route in the right deltoid.  On 31-MAR-2022 the patient developed a non-serious event  expired dose of daptacel was given to a patient ; practice discovered that the daptacel that was administered had expired ( with no reported adverse event) (expired product administered) (unkown latency).  It was reported that is there any safety data on giving an extra dose of Daptacel (or other vaccines), how does Daptacel compare with Adacel in terms of the amount of the active ingredients/antigen in each of the vaccines and the age ranges they are approved for, is there information on use of Daptacel in patients 7 years of age and old as a booster.  Action taken 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 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.
Sudden onset tongue numbness and throat tingling s/p  Pfizer Covid19 vaccine admin. VS per RN notes. Pt given Benadryl 25mg IM ROUQ per standing order and pt. request . Pt symptoms resolved. VS returned to baseline. Airway remained patent. No adventitious lung sounds noted. Pt elects to DC home W/ACI  and CDC form. Pt states she is a hospice nurse and well versed on Vaccine RXN. Pt in good spirits. **refer to written RN note**
Dtap (peds) given instead of Tdap. Called Pt 5/15/07. Pt reported only minor pain at injection site.
My first shot kicked me out of menopause. I had a full cycle after 3 years of no period; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer-sponsored program A female patient of 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 single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported "My first shot kicked me out of menopause". I had a full cycle after 3 years of no period". The adverse event onset date was on 22Apr2021 (12:32). The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
10 min. after vaccine injection: headache, scratchy throat and throat tightening lasting for about 10min and subsided.   50 min. after vaccine injection:  flushed, redness in face, ears, and neck progressing to rash on chest, neck.  Lasted for about 10min and subsided.  Never progressing into full anaphylaxis reaction.  No treatment taken.
Mother brought child to HD office 8/3/09 PM to report that child's arm became tender, with redness over deltoid spreading to just aboeve the elbow PM 7/31/09.  c/o being tired and "just not feeling well" continuing today.  there had been a "knot" in her arm, but it is now gone. Did not check for fever.  Gave Ibuprofen, used cool compress off and on for 2 days.
Special Needs Child Autistic- immediately after vaccine slouches over, hands over eyes, touching eyes, then looked at parent; parent states one eye was looking at parent the other eye was steered to the opposite direction viewing away from parent; patient then collapsed to the  floor. Paramedics called, patient was attended by EMT 's; pt then regained consciousness and per parent pt has seemed like his self since
pt recv vax & 12JUN97 lab eval revealed a lack of seroconversion;
Shaking chills woke me up in the night, nightmares, really painful in the arm where I got the shot
HCP reported 2 month old male developed bloody diarrhea 1 week after receiving VAXELIS; This non-serious spontaneous safety report with reference number # 02409163 (# 02409160) was received by a partner on 16-JUN-2023 and forwarded on 16-JUN-2023 from a physician.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event of "HCP reported 2-month-old male developed bloody diarrhea 1 week after receiving VAXELIS".  Further information is expected.
2100 splitting headaches lasting 24 hours - still have residual headache 2100 - 2100  (next day) body aches and pains involving all muscles, bones, nerves, from top of head to toes and everything in between - severe pain not relieved by paracetamol.  Inability to sleep - due to pain and headache. Blurred vision. 0100 nausea- not able to drink for 24 hours leading to dehydration. Numb fingertips. 10/06/2021 - red and swollen left upper arm extending to mid shift of upper arm. Redness, swelling bruising and pain for 2 weeks 09/06/2021 - current continuing headaches, lethargy and numbness in fingertips
After  Moderna second dose and Booster,  I got a case of the shingles, within one week of each dose. Could not be coincidental!  Took anti-vial which helped clear it up, but very painful
Symptom onset was 12/26/2020, with nausea, fever, chills, rigors, fatigue, cough, & myalgia.
Papular rash on face, trunk, extremeties a few with vesicles;  c/o h/a, itchy rash and sore throat; ACYCLOVIR 200/5, 3 1/2 top QID X 5d and Amox.  400/5, 1 1/2 top BID X 10d
Normal side effects except extreme pain at back and left kidney. Felt like I had been kicked in the kidney by a mule. Lasted Wednesday  through Friday. Could not get comfortable.
After 15 minutes patient noted feeling light headed, dizzy and experiencing  blurry vision. Vitals were stable, patient was seen by our Walk In Provider for further evaluation.
COVID vaccine inefficacy; COVID vaccine inefficacy; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID vaccine inefficacy". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information available, there is causal association between the events drug ineffective, covid-19 and the suspect drug BNT162b2 cannot be excluded . The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient recieved PNA vaccine on day of discharge from hospital, returned next am with pain and swelling at the site.  Advancement of Red line marked and during stay in ED the redness expanded beyond the border drawn.  Pt was admitted and MRI obtained.  Pt given Vancomycin and then discharged the next day when pain and swelling had reduced.
Shingrix late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 15-NOV-2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Shingrix late second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: Receipt Date: 16-AUG-2023 Pharmacist was looking for information about late second dose of Shingrix and the efficacy data for one dose only. They had patient that their first dose was 2 years ago from reporting. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. This case was 1 of 2 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2023111553:same reporter, 2nd case
Day 2 & 3 after my vaccine, I had fatigue & shortness of breath. On Day 3 , it began with a little nausea that became worse, along with shortness of breath. Ado I also pain followed, & no medication or rest with a heating pad helped. After 7 hrs. I sought treatment at  Emergency Room. After several tests, and an abdominal cat-scan, it revealed that I had appendicitis, and would need an appendectomy soon. At 5:30 am I received an appendectomy from . I stayed overnight in the hospital.
Pfizer vaccine mistakenly reconstituted with 0.8ml of sodium chloride instead of 1.8ml. Pt was administered 0.3ml of Pfizer IM in left arm. Pt was observed for 15 minutes and reports no adverse reactions.
feeling lousy; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Hepatitis A vaccine for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on unknown date).   On 26th May 2020, the patient received the 2nd dose of Shingles vaccine and Hepatitis A vaccine. On 27th May 2020, 1 days after receiving Shingles vaccine and Hepatitis A vaccine, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was unknown.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine and Hepatitis A vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received shingles shot and hepatitis A vacine on same day anf felt lousy. No other information was reported.
Information has been received from a nurse concerning unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX, injection, via subcutaneous route, lot # M003440 with expiration date of 20-JAN-2018 (dose was not reported), reconstituted with properly stored sterile diluent (manufacturer unknown). Administered doses of vaccines experienced temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 72 hours. There was no previous temperature excursion. Digital data logger was not involved. There was no product quality complaint. This is one of two reports received from the same reporter. Follow-up information was received on 08-AUG-2017. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.; Sender's Comments: US-009507513-1706USA007811:
Started with a Headache, Cold like symptoms nasal congestion Minor Sore Throat.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 01Mar2021 at 09:00 as dose 1, single (Lot number: En6202), in left arm, on 22Mar2021 at 09:00 as dose 2, single (Lot number: Ep7534), in left arm, on 08Oct2021 at 13:00 as dose 3 (booster), single (Lot number: 30155ba), in left arm and on 15Apr2022 at 17:00 as dose 4 (booster), single (Lot number: Fm9992) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Glaucoma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Fever - 102.7 with chills no other sx only tx. Fever protocol.
Information has been received from a registered nurse concerning a child who in approximately August 2006, was vaccinated with Varivax. In approximately September 2006, the patient developed a rash approximately 24 lesions. Follow up information indicated that the school nurse did not have any more details, and would not have any more information. No additional information is expected.
Flu shot never caused severe allergic reaction. But the pneumonia 23 vax was given without asking nor telling me what brand in the office. Within few hrs my right arm was twice normal size in my bicep muscle. No reaction at injection site. Bicep swelled along with pain and swelling accompanied by rash red area where muscle was hard extreme pain tenderness bruising of bicep. Called doctors to make apt Friday 18th..after shots administered feb 15 2022 by 18th doc said benadryl sent me home.  Very unprofessional to not ask what strain or type of vaccine being used when they just picked one for me inform me I asked for the pneumonia vaccine not to be given the 65 an older 23 vaccine nobody even asked me or even showed me what I was getting before given the shot
Myalgia, Fever, fatigue, all symptoms ended 1/27/21 Narrative: