chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 18-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case is linked with 2019SA079860 (same reporter). This case involves a 23 months old male patient who received expired dose of DAPTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HIB; Hepatitis A and MMR for Immunisation. On 18-Mar-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE lot C5157AA expiry date: 23-Feb-2019 via unknown route in the right leg. It was an actual medication error due to expired vaccine used. Nurse reported an expired dose of DAPTACEL was given to the patient. It was not reported whether the patient experienced any adverse event or not. 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. List of documents held by sender: none.
Information has been received from a licensed practical nurse concerning a female who was vaccinated with Gardasil. There was no concomitant medication. Subsequently the patient experienced burning sensation after receiving the vaccination and sought medical attention. Subsequently, the patient recovered from the burning sensation. No product quality complaint was involved. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Initial and follow-up information has been received from a licensed practical nurse (LPN) concerning a 10 year old female, who on 26-MAR-2007, was vaccinated intramuscularly with a 0.5 mL dose of GARDASIL, (Lot # 657868/0523U), expiration date 09-FEB-2010). There were no concomitant medication. Subsequently the patient experienced burning sensation after receiving the vaccination and sought unspecified medical attention. The symptom lasted for a few minutes. Subsequently, the patient recovered from the burning sensation. No product quality complaint was involved. In follow-up it was reported by the LPN that the patient complained of burning and soreness at the injection site after the medication was administered. It was reported that the burning lasted for approximately one hour. At the time of the report, it was unknown if the patient recovered from soreness at injection site. No medication treatment was needed. Additional information has been requested.
I do not have a monthly period as I have the mirena  IUD. I have not had a period in the last 6 months. I revived the Pfizer COVID 19 vaccine, on March 25, and had cramping and started my cycle on March 27
I have now been diagnosed with Antiphospholipid syndrome.  I have been a vegetarian for 35 + years and have never been sick until having had the vaccine.
Hives, body rash, headache, throat tightness, itching I was giving Benadryl through IV and Tordol
diagnosed with Covid after receiving the Pfizer Covid vaccines; diagnosed with Covid after receiving the Pfizer Covid vaccines; diarrhea; dehydrated; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A female patient received BNT162b2 (BNT162B2), 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 included: "pregnancy" (unspecified if ongoing), notes: from her post pregnancy that was terminated due to other medical reasons. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (hospitalization, medically significant), DRUG INEFFECTIVE (hospitalization, medically significant), outcome "unknown" and all described as "diagnosed with Covid after receiving the Pfizer Covid vaccines"; DIARRHOEA (hospitalization), outcome "unknown", described as "diarrhea"; DEHYDRATION (hospitalization), outcome "unknown", described as "dehydrated". The events "diagnosed with covid after receiving the pfizer covid vaccines", "diarrhea" and "dehydrated" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: UNKNOWN RESULT. Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course: patient is pregnant of 21 weeks and she has been diagnosed with Covid and prescribed Paxlovid.  He needs to know safety data on medication.  He said her first pregnancy was terminated around the same time frame and for similar medical reasons. Patient had severe side effects from Covid.  Patient has not started Paxlovid.  Patient was admitted to the hospital due to severe side effects of Covid and she had diarrhea and she was dehydrated. Emergency Room prescribed Paxlovid. Patient was vaccinated with series of two vaccines of Pfizer vaccines but not the booster.  Patient  received vaccines before being diagnosed with Covid.  He said she got pregnant and then this happened.  Caller declined to complete report.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product 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.,Linked Report(s) : US-PFIZER INC-202200762603 same patient/drug, different dose/event
. Initiated with  stroke / hemiplegia  episode ,photophobia . Face twitching . And lead to complete  bilateral  leg paralysis and sensitivity to sound , lights and all stimulation , later  evolved to left side paralysis and numbness and twitching and tremors on left side . Later evolved to full body convulsion and currently absent seizures type activity followed by paralysis of both legs . And slow speech and slow thinking process present in all stages .no treatment yet
Spoke w/Mom--mood has been variable from "regular to fussy to sleeping"--temp was 102.8* reduced w/motrin.
no additional adverse effects; an adult patient was administered a pediatric dose of VAQTA; This initial spontaneous report as received from a nurse refers to an adult patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. This case concerns 1 patient and 1 combination product.   On 12-MAY-2020, the adult patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not reported) (lot # S032056, expiration date: 09-NOV-2020) (exact dose, route of administration and anatomical location were not reported) for prophylaxis. No additional adverse effects were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S032056; expirationdate: 09-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Patient and patient's family presented for seasonal flu vaccine. Mom filled out VAR for daughter. All questions were checked as "NO". "No" was answered for feeling sick today, any health conditions, any allergies, ever had any reaction to a vaccine, any seizure disorder or pregnancy. Patient received vaccine intramuscular in left deltoid. Approximately 10 minutes later, patient felt light headed and sat down on the floor. Patient stated that she didn't feel good and passed out. Paramedics were summoned and patient was transported to Medical Center. Mom stopped in about 3 hours later to update me. Mom stated that daughter has orthostatic hypotension but was not affected by vaccines previously. Patient does develop a seizure when she passes out per mom. ER doctor did not believe the patient passing out was related to the flu vaccine. Patient was back home by about 1000.
Arm soreness - onset immediately after vaccination; resolved in 3 days with no treatment Extreme fatigue - onset within 2 hours of vaccine; resolved in 3 days with no treatment Headache, joint pain, lymph node swelling (armpits and neck) - onset within 12 hours of vaccine; resolved in 3 days with no treatment Early onset of menstrual cycle, heavier than normal menstruation - onset within 12 hours of vaccine; no treatment
Began with a sudden fever of 102.6 (11/1/14) then rash on trunk and inside of arms, then spread to face. Urgent care visit (11/4/14) followed by an ER visit the next morning due to rash all over face (11/5/14). She has never had any allergies, or had any chronic eczema or skin conditions, and since the immunizations on 10/24/14 she has been diagnosed with eczema. Last night (11/24/14) she had an immediate allergic reaction to something she ate at dinner, which has never happened before. We believe this all came about after the immunizations administered on 10/24/14. She received DTaP, Hib-PRP-OMP, MMRV, and Pneumococcal Conjugate PCV13.
Anaphylactic Shock. Administered SOLU-MEDROL, PEPCID, epinephrine. Had repeated rebound anaphylactic events over the next 7 days requiring ER treatment and lifesaving efforts. Hospitalized due to anaphylaxis from vaccine from 08/19/2016 to 08/21/2016.
Client presented to local vaccination site on 2/21/22. The client reported that he received a 1st dose of Pfizer COVID-19 vaccine on 2/1/22. Client was one day early to receive 2nd dose of Pfizer COVID-19 vaccine and client's mother requested to have client vaccinated on 2/21/22. Client reported having localized arm pain, fatigue, and feeling dizzy after receiving his first dose of Pfizer COVID-19 vaccine. Client reported symptoms lasting one day post vaccination. RN gave client water bottle and client drank from it. Client stated last meal was "about 2 hours ago". RN submitted a medical consult via text message to clinical project coordinators requesting to proceed with the Pfizer COVID vaccine. Per Dr. approval to proceed with Pfizer COVID vaccine was obtained from medical consult team via text message from, clinical project coordinator. Client received Pfizer COVID-19 vaccine, LOT#: on 2/21/22 at 1707. The client did not report any symptoms during the 15 minute observation period. RN educated client and mother on possible adverse reactions and when to seek EMS. Client and clients mother verbalized understanding. Client left vaccination site at 1725 unassisted and with a steady gait accompanied by his mother.
Sudden onset of left thigh edema and erythema with associated tenderness: Approximately 20 cm x 12 cm area of induration that resolved within 48-72 hours with ice and over the counter medication.
sore, swollen arm, 9 days after the ADACEL shot (left arm only)
Pfizer-BioNTech COVID-19 Vaccine EUA Patient received her second dose of the Pfizer COVID vaccination  and felt some heaviness in her chest and tingling in the lips shortly afterward.  Patient had some similar symptoms on the first vaccination, but felt better following Zyrtec administration.  Her symptoms today were persistent despite receiving Zyrtec so she was sent to the emergency room for evaluation.  On evaluation, patient reports feeling little bit off as well as some nasal stuffiness.  Patient was observed in the emergency department for over an hour without developing any new or worsening symptoms.  Patient was discharged home
Began testing due to exposure and tested positive on 12/17/2022 for COIVD-19. Symptoms were really mild with congestion and sore throat being the worst. Reached out to PCP and was placed on Melenoveer and I have been taking it BID. Close contacts have been notified and are isolating.
Pt developed redness and pruritis to left hand and left forearm 20 min after vaccine.  Pt given 25 mg of Benedryl po.  Rash faded 10 min after onset.
Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 34 years old female patient who supposed to vaccinated with TYPHIM VI. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 04-Oct-2018, the patient received a dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (lot N1K811M and Exp. Date 19-Oct-2019) via intramuscular route in the left arm. This is a PTC case as it involves syringe issue and hence patient experienced underdose. It was reported that, the coupling that the needle attaches to blew out. Caller clarified the Luer Lok with the needle still attached snapped off, and the needle was stuck in the patient's arm, and the vaccine "squirted everywhere. Patient was concerned, but needed no treatment following this. Caller states he thinks he twisted off the tip cap on this syringe, but does not recall. Caller states he screwed on the needle, and tightened it on like other vaccines that he gives. The needle didn't feel like it screwed in as tightly as it normally would, but I don't give a lot of typhoid injections so I thought it was normal. Vaccine given IM, left arm. No information about relevant tests reported. Final diagnosis was the vaccine squirted everywhere and snapped off and the needle was stuck in the patient's arm. No information about a corrective treatment reported. List of documents held by sender: none.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider at a healthcare facility recommended and or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 11-SEP-2006, a health care provider (unspecified healthcare professional) administered the ZOSTAVAX (lot number, dosage and route of administration not provided) to the patient. On or about 25-DEC-2014, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (not further specified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Child received shots 1/17/2005, on 1/19/05 mom said child's arm twice normal size and hurts. Used Tylenol and ice. Sent to ER, diagnosis cellulitis, local reaction from immunization. To use Benadryl and Advil
This case was reported by a consumer and described the occurrence of anaphylaxis in a patient who received Flu Seasonal QIV Dresden (fluarix Quadrivalent 2021-2022 season) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. Previously administered products included fluarix Quadrivalent with an associated reaction of no adverse event (received dose on an unknown date in 2019), Flucelvax Quad with an associated reaction of urticaria (received dose on an unknown date in 2020) and fluarix Quad with an associated reaction of no adverse event. On an unknown date, the patient received fluarix Quadrivalent 2021-2022 season and fluarix Tetra Pre-Filled Syringe Device. On an unknown date, less than a year after receiving fluarix Quadrivalent 2021-2022 season and fluarix Tetra Pre-Filled Syringe Device, the patient experienced anaphylaxis (serious criteria GSK medically significant) and allergic reaction. On an unknown date, the outcome of the anaphylaxis and allergic reaction were unknown. It was unknown if the reporter considered the anaphylaxis and allergic reaction to be related to fluarix Quadrivalent 2021-2022 season and fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had received 2020 Flucelvax Quad PF flu vaccine and that year got hives after receiving that vaccine. The patient was trying to get information on the ingredients in the 2021 fluarix Quad PF and fluarix QIV PFS flu vaccines. The patient had an anaphylaxis response to the 2021 version, but no reaction to the 2019 version. The patient was working with an allergist to figure out the specific ingredient in the flu vaccine to which the patient was allergic so the patient could find a flu vaccine in fall of 2022 to which the patient was not allergic. The patient did not have a reaction to any vaccine other than flu.
Pt. reported upon TST reading 6/20/19, that she had a reaction to the vaccine she received on Tuesday approx. 30 minutes after receiving. Pt. describes muscles spasms, nausea, arm pain, fever to 101.5F, high blood pressure (130/70), dizziness and chest pain. Pt. did not seek out medical care Tuesday 6/18/19. When attending classes Wednesday 6/19/19, she reported to instructor that she felt ill, instructor checked her VS and then instructed her to seek out medical care. Pt. went with Mother to Clinic to access care. There, per Pt. "they said that I received the vaccine in error as the timing was wrong, which is why I was having the reaction. I was treated for my fever and observed for several hours." Pt. states that she feels fine today 6/20/19 and that clinic instructed her to get her BP taken while at Public Health for TST read. BP was normal 122/70- taken by RN. Pt. and Mother were unsure if clinic had called to report vaccine reaction to Public Health. Vaccine verified by Public Health, was given within normal time frame per guidelines/GSK insert.
Injection site right deltoid. Lower deltoid developed red blotchy areas, warm to touch w/ min discomfort and min swelling. Pt stated that 24 hours after injection arm was very sore and had difficulty raising arm. Then the next day had minimal pain but by evening noticed red blotchy area. Instructed pt to apply cool compresses and take an antihistamine. Also instructed to f/u prn for worsening s/s.
Shingles; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th October 2022, the patient received the 1st dose of Shingrix. In October 2022, 1 week after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-DEC-2022 Reporter's Comment:  The reporter reported that the patient received Shingrix vaccine. The reporter stated that a week after receiving  Shingrix vaccine the presented an episode of Shingles. The reporter declined the information about vaccine like batch number and expiration date because the vaccine was received at a different pharmacy. The reporter consented to follow up via email.
2 days after the Moderna booster, patient experienced hives, which he continues to experience. He also experience momentary vision change x2: everything goes sideways in lines and cannot see.
Vaccine Administration Error: I was given the High Dose Fluzone vaccine for 2019/2020, which expired on 6/30/20, instead of the High Dose Fluzone vaccine for 2020/2021.  About 1-2 hours after I was given the vaccine, I received a telephone call from  the woman who had administered it to me, to tell me she had given me the wrong vaccine and that I needed to come back for the proper vaccine.  I was astonished, of course, and questioned how this could happen.  She admitted she had not checked the vaccine before she gave it to me.  I also asked why in the world they still had the 2019/2020 vaccine in their office, and she had no answer.  She told me she had checked with the director of the Pharmacy, and was told that it was safe for me to come back in for the proper vaccine.  However, I have lost trust in this clinic now.  I called my pharmacist, who suggested I wait 2 weeks for the proper vaccine just to be safe, which I am doing.
patient received the first dose of SHINGRIX 3 years ago, and not received 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 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 3 years ago).   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: patient received the first dose of SHINGRIX 3 years ago, and not received second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 09-JUN-2023 A pharmacist reported about a patient who received the first dose of SHINGRIX 3 years ago, and never received the second dose. The reporter did not consent to follow-up. Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination. This case had been linked with case US2023081615 reported by same reporter.; Sender's Comments:  US-GSK-US2023081615:Same reporter
After 20 minutes of administration of vaccine H1N1, left deltoid area turned red and pruritus at arm and neck. Pt was administered BENADRYL IM and oral steroids (ORAPRED 15 mg ODT oral disintegrating tab).