chrisvoncsefalvay/vaers-outcomes huggingface dataset:
after the patient had received the complete schedule for Engerix-B; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on December 2020), Twinrix (received 2nd dose on January 2021) and Engerix B (had received the complete schedule for Engerix-B on unknown dates).   On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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 details provided were as follows: Age at vaccination was not applicable for this report. Pharmacist reported that, the patient received 2 doses of Twinrix and did not receive 3rd dose till the time of reporting, which led to incomplete course of vaccination. Twinrix was started after patient had received the complete schedule for Engerix-B. The reporter did not consented to follow-up. The VAERS details pertains to previous doses.
At about 0330 on 09/07/19  patient began having nausea, vomiting, body aches, chills, extreme sweating, pain and redness around injection site, and fatigue. Patient took Tylenol for pain, but could not hold anything down due to nausea. Signs and symptoms resolved by the evening of 09/08/19.
Tdap administered R deltoid 1/16/08. Pt describes site becoming swollen & red up to 4 cm circumference with a burning sensation.  She felt dizzy & went to bed. Denies having respiratory or cardiac symptoms. Over the next few days the site decreased in size & she presented today to report her symptoms.  The size of the swelling & redness around the injection site was now 15cm circumference with no pain or burning or other worrisome symptoms.
Headache BODY ACHES, CHILLS, FATIGUE Narrative:  Other Relevant History:
Dizziness, feeling unwell/nauseated, joints feel swollen (fingers, face, hands, feet, posterior knee joint), neck pain, cold night sweats, injection site pain. Symptoms come and go.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 29Dec2020 as dose 1, single (Lot number: p220395-0022l), in left arm, on 21Jan2021 as dose 2, single (Lot number: p220395-0022l), in left arm, on 01Oct2021 as dose 3 (booster), single (Lot number: p220395-0090l), in left arm and on 09May2022 as dose 4 (booster), single (Lot number: fp4554), in right arm for covid-19 immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing); "obesity" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: ZYDUS, start date: 01Jun2022, stop date: 28Dec2022; PRINZIDE, start date: 01Jun2022; NORVASC, start date: 01Jun2022; ABILIFY, start date: 01Dec2021, stop date: 28Dec2022; PROTONIX [OMEPRAZOLE], start date: 01Dec2021, stop date: 28Dec2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jan2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid.  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: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 and the reported events "vaccination failure", "COVID-19".,Linked Report(s) : US-PFIZER INC-202300015921 same patient and suspect vaccine; different dose and event;
I know 4 ppl myself you got shingles from the shot/ Suspected vaccination failure; know 4 ppl myself you got shingles FROM the shot; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I know 4 ppl myself you got shingles from the shot/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: know 4 ppl myself you got shingles FROM the shot). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 11-Jun-2023 The case was received from the consumer via interactive digital media. The reporter know the patient himself or herself and stated that got shingles from the shot. In the instance they lasted over a year debilitating for sure. This report is one of four linked patients, reported by same reporter. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR082851:same reporter US-GSK-US2023AMR082853:same reporter US-GSK-US2023AMR082854:same reporter
Went into afib with resting heart rate was 120+ and stayed in afib for 3 weeks. Medication was slightly controlling my heart rate but had to get an emergency ablation  procedure
Patient is 17 years old and received Moderna which is approved for 18yo and up. No adverse reaction
03/24/2003 Patient c/o fever, night sweats, enlarged lymph nodes, insomnia times 4-5 days.  Had red streaks on the medial upper arm and the axilla. Patient also had 3 satellite lesions to his low and upper back. Was taking Benadryl and Tylenol.  Was referred to Dr. and was seen on 3/25/03. Was kept out of work til 4/3/03.
no adverse effect reported; Improperly stored doses of MMR II and VARIVAX were administered to the same patient; Improperly stored doses of MMR II and VARIVAX were administered to the same patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.  On 21-JUN-2018, the patient was vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) , 0.5 milliliter, subcutaneously (invalid lot# reported as N045101, expiration date 10-NOV-2018), and varicella virus vaccine live (oka/merck) (VARIVAX) (the dosage regimen was not reported) lot# N012132 (expiration date: 17-APR-2019), both of them for prophylaxis. No adverse effects were reported.  The vaccines were exposed to a temperature of 55.7 Fahrenheit degrees for a timeframe of 8 hours and 30 minutes. It was found because of a digital data logger.
Everyone in the office was brutally sick, all but one person; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Everyone in the office was brutally sick, all but one person) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Everyone in the office was brutally sick, all but one person). At the time of the report, ILLNESS (Everyone in the office was brutally sick, all but one person) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD21-088258, US-MODERNATX, INC.-MOD-2021-114635, US-MODERNATX, INC.-MOD-2021-114654 (Linked Report).; Sender's Comments:  MOD21-088258: US-MODERNATX, INC.-MOD-2021-114635: US-MODERNATX, INC.-MOD-2021-114654:
Fever and headache.  Felt flu-like for 24 hours.  By Sunday morning I was fine
The patient came in today to pick up a cephalexin antibiotic.  She was already at her dr's office today, and her arm was slightly swollen and red.  The dr. wasn't sure if she was developing an infection or not, so he just prescribed her the cephalexin to be safe.  The patient wasn't upset or bothered.
12-29-14 clt never immunized as a child and received 3 immunizations on 12-18-14. Clt states 2 days after immunization experienced fatigue, achiness and weakness. On 12-23-14 clt experienced night sweats that lasted approx 4 days. On 12-28-14 clt states she broke out in rash on face, neck and trunk. Clt also reports swollen lymph nodes in (L) armpit. Referred clt to physician for evaluation. 1-13-15 clt states she was seen by a provider and dx with viral illness. Clt states sx resolved by 1-1-15. Clt received ok from provider to receive subsequent immunizations.
p/vax site erythema ;erythema & edema/induration;erythema 8x11cm;edema/induration 5x5cm;tx warm compresses, DPH;improved transiently w/DPH;
Patient received Anthrax vaccine Lot FAV256 prior to deployment at health clinic. The next day, left arm was swollen and unable to move with pain around injection site.
This non-serious spontaneous case, initially received on 15-Mar-2018, was reported by a other health professional and concerns a 31-year-old adult female patient. The patient's concomitant medication included Pneumococcal vaccine (administered on 18-Jan-2017). On an unspecified date first temperature excursion of the vaccine occurred. On 18-Jan-2017, the patient was administered with AFLURIA (TIV) (dose: 0.5 ml, anatomical location: left arm, batch number XT59906, expiry date: 06-Jun-2018, route of administration: not reported) stored out of range. On an unspecified date, the vaccine was stored out of range for 65 hours and 35 minutes, reaching a highest temperature of 60 F which was the fifth (5th) excursion with those vaccines. Non-significant case correction received with IRD 15-Mar-2018: Narrative was corrected (word 'date' was added in sentence). Amended narrative accordingly.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies, medical histories, drug reactions or allergies provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot# M018810, expiration date 28-MAY-2018 (dose was not reported). There were no adverse effects reported. Product quality complaint (PQC) was not involved. Administered doses of vaccines were exposed to the temperature of 46.8 degrees Fahrenheit for 2 hours (date unspecified). A digital data logger was not involved. There were no previous temperature excursions. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments:  US-009507513-1612USA007060.
Pharmacist drew up the incorrect vaccination for the patients. Patient was administered 0.2 of Adult Pfizer vaccination instead of 0.2 of Pfizer vaccination.
This case was reported by a healthcare professional and described the occurrence of anaphylaxis in a 45-year-old female subject who was vaccinated with Flulaval (GlaxoSmithKline).  Concurrent medical conditions included hypertension.  Concurrent medications included Benicar.  On 3 October 2007 at 09:30 the subject received unspecified dose of Flulaval at 0.5 ml, intramuscularly in the left arm.  On 3 October 2007, five minutes after vaccination with Flulaval, the subject experienced anaphylaxis.  The healthcare professional considered the event was clinically significant (or requiring intervention).  At the time of reporting the outcome of the event was unspecified.  Follow-up received on 22 October 2007 via the healthcare professional.  She reported that the events resolved on 13 October 2007.  The healthcare professional considered that the events were serious and life-threatening.  The subject was hospitalized.  Diagnostic testing revealed normal results for cardiac enzymes, complete blood count, metabolic profile and electrocardiogram. The healthcare professional considered that the events were not related to medical history of concurrent illness, lack of efficacy, erroneous administration or suspected transmission of an infectious agent via a medicinal product.  The healthcare professional considered that the events were related to the use of Flulaval.
Information has been received on 17-OCT-2016 from a pharmacist referring to a patient of unknown age and gender. The patient's medical history and concomitant therapy were not reported. On 07-MAY-2015 the patient was vaccinated with ZOSTAVAX (lot # K012786, expiration 28-NOV-2015), 0.65 ml subcutaneous. On 13-JUL-2016, the patient was inadvertently vaccinated with ZOSTAVAX (lot # L035285, expiration 12-DEC-2016), 0.65 ml subcutaneous. No adverse effects reported. No further information was reported. Additional information has been requested.
Developed low grade fever from 25MAR-29MAR; Highest fever 105R taken to MD no other illness MD reports poss viral infect rxn to MMR; Also, developed rash on torso (front only) on 2APR91;
No adverse event; HCP stated a vaccine that expired in 02Apr2022 was administered to 2 patients on 05Apr2022; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated a vaccine that expired in 02Apr2022 was administered to 2 patients on 05Apr2022) and NO ADVERSE EVENT (No adverse event) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 prophylaxis.     It was reported that HCP did not describe medical history or condition. It was reported that patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated a vaccine that expired in 02Apr2022 was administered to 2 patients on 05Apr2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated a vaccine that expired in 02Apr2022 was administered to 2 patients on 05Apr2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP stated a vaccine that expired in 02Apr2022 was administered to 2 patients on 05Apr2022).    No concomitant medication was reported. Suspect product dosage text was reported as unknown. It was reported that patient received the second booster. This case is reported for patient 2. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-734675 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734675:Same Reporter ,Patient 1
felt kind of bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (159558).  A 38-year-old female patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, 0.3 ml single (Lot number: EN6199, Expiration Date: Jun2021) at the age of 37 years, in left deltoid and on 26Mar2021 as dose 2, 0.3 ml single (Lot number: EN6206, Expiration Date: Jun2021), in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Hypertension, Takes medication for that. It was managed. Been at least 5 years; "High BMI Is overweight, but not 600lbs" (unspecified if ongoing); "High BMI Is overweight, but not 600lbs" (unspecified if ongoing). There were no concomitant medications. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt kind of bad". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Additional Vaccines Administered on Same Date of the Pfizer Suspect: None. Adverse Event (AE) Details: Provide the time of onset of AE(s): Not provided. Did any AE(s) require a visit to Emergency Room/ Physician Office: No. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): None. AE(s) following prior vaccinations: None. Please specify Antipyretic Use (around the date(s) of Vaccination): Sure patient did in the day or two after. Caller states they all felt kind of bad after getting the vaccine, so probably patient did take an antipyretic. Caller clarified they all felt bad after getting their COVID-19 Vaccines.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200842587 Same patient and drug, different event separated in time;
developed body chills Friday night with a 104 degree temp.  Next day high temp continued topping out @ 105.7 degrees with a resting heart rate of 96 (normal is high 50's to low 60's).  General sense of malaise, no energy.  Stayed hydrated all day, took 600 mg Advil @ 7:30 a.m., followed  1,300 mg of Tylenol @ 5;30 p.m.  Hi temp continued, took add'l 1,300 mg Tylenol & 800 mg Advil @ 8:30 p.m. and temp finally dropped to 102 degrees.  Slept pretty soundly Saturday night and feel much better on Sunday but still not 100%.  Took temp @ 5:30 p.m. today and temp back up to 103;5 degrees.  Took 600 mg Advil & 1,300 mg of Tylenol.
After my second booster I began getting an aura with flashing lights and nausea along with my migraine.  I had a migraine for 4 days in a row.  With the first vaccines I had migraines but with this booster it was worse.  I took Prednisone for 5 days.  That seemed to help.  I recently got another migraine that lasted about 2 days.  I take Tylenol, Flonase and coffee to help with pain.  I have now been prescribed Sumatriptan.  I have a follow appointment in 3 months.
Client was given MenB, vs recommended Men ACWY for her age. No adverse effects to client, as doctor's office identified discrepancy and notified client's parent.
sore arm; This case was reported by a physician via sales rep and described the occurrence of pain in arm in an unspecified number of  patients who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The physician made a general statement regarding his clinical experience with Bexsero. The physician stated patients experienced a sore arm.
11JUL96 pt recv vax & 21JUL96 pt awake w/t102.2 oral;c/o agitation & crying;22JUL96 t103 oral, rash on face, chest, upper back & shoulder;c/o crying uncontrollable;23JUL96 notified own MD dx rxn to MMR-but now improved
Pt received first dose of Moderna vaccine and within a few minutes started developing a tingling feeling in her mouth and elevated BP.   Provided  Cetirizine 10 mg then Benadryl 25 mg. SBP has been from 182 - 210; O2 sat 100% and have been monitoring her for the past hour and a half.  Patient still has the tingling feeling and a feeling of rawness in her palate. discussed with allergy; refer pt to ED and check tryptase level to see if true allergy. This will affect whether she gets her second shot. Pt received first dose of Moderna vaccine and within a few minutes started developing a tingling feeling in her mouth and elevated BP.   We initially gave her Cetirizine 10 mg then Benadryl 25 mg . SBP has been from 182 - 210; O2 sat 100% and have been monitoring her for the past hour and a half. She still has the tingling feeling and a feeling of rawness in her palate. discussed with allergy; refer pt to  ED and check tryptase level to see if true allergy. This will affect whether she gets her second shot.  Patient went to emergency room for observation and sent home without additional intervention.
Patient reported of feeling dizzy and nauseated. Pt fell to the floor a few seconds after.
A non-serious spontaneous report of received expired FLUMIST was received from a health professional concerning a five-year-old male. Neither the patient's past medical history nor the concomitant medications were reported. The product expired 05-Feb-2012. On 09-Feb-2012, the patient received expired product. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. The reporter stated that the patient did not experience any late occurring adverse events.
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated 5 times with the Pfizer product, having received vaccine on 02/03/2021, 02/24/2021, 08/27/2021, 03/02/2022, and 08/17/2022. They were hospitalized 09/15/2022-09/23/2022for multiple reasons, including small bowel perforation, shock, hypoxic respiratory failure, multiple metastasized adenocarcinoma of the lung, acute renal failure, and a-Fib. They were transferred to a hospice facility on 09/23/2022. They tested negative for COVID-19 on 09/15/2022 and then positive on 09/25/2022 and 09/26/2022. Their health continued to decline and they died on 10/04/2022.