chrisvoncsefalvay/vaers-outcomes huggingface dataset:
after booster dose-A few months later, the patient was diagnosed with an immunocompromising condition; This spontaneous case was reported by a nurse and describes the occurrence of IMMUNODEFICIENCY (after booster dose-A few months later, the patient was diagnosed with an immunocompromising condition) in a female patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced IMMUNODEFICIENCY (after booster dose-A few months later, the patient was diagnosed with an immunocompromising condition) (seriousness criterion medically significant). At the time of the report, IMMUNODEFICIENCY (after booster dose-A few months later, the patient was diagnosed with an immunocompromising condition) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   A healthy patient received the 1st and 2nd dose of Moderna vaccine at 0.5 mL volume . After which, she received the 0.25 mL recommended booster dose . A few months later, the patient was diagnosed with an immunocompromising condition Reporter stated that will the patient get the 0.25 mL dose as the booster dose? What happen to the 0.25mL 3rd dose the patient received? Will it provide the patient sufficient protection. Concomitant product use was not provided by reporter. Treatment information was not provided.  Company comment: This spontaneous case concerns a female patient of an unknown age, with no reported medical history, who experienced the serious (medically significant) unexpected event of immunodeficiency. On unknown dates, the patient received 3 doses (2 doses of 0.5 ml and 3rd dose of 0.25 ml) of mRNA 1273 COVID-19 vaccine. A few months after the third dose of mRNA 1273 vaccine, patient was diagnosed with an immunocompromising condition. No further information was provided. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of an unknown age, with no reported medical history, who experienced the serious (medically significant) unexpected event of immunodeficiency. On unknown dates, the patient received 3 doses (2 doses of 0.5 ml and 3rd dose of 0.25 ml) of mRNA 1273 COVID-19 vaccine. A few months after the third dose of mRNA 1273 vaccine, patient was diagnosed with an immunocompromising condition. No further information was provided. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
24 hours after receiving the vaccine, developed body aches, chills, low grade fever and fatigue, which lasted 24 hours.  Fatigue and weakness lasted another 12 hours.
Pt had 1st set of shots around 1030 on 4-21-14, 1 hr after shots started with 101 and up then became very fussy, could not console her all day. Doing better today, still has sl. temp.
Syncope within 3 minutes of receiving vaccination, was sitting.  Regained consciousness easily.  States she has felt dizzy when received a flu vaccination in past.
+ erythema, induration, warmth at all three injection sites. DTAP/HIB left leg 7cm oval shape. Prevnar right leg 5cm round
Information has been received from a registered nurse concerning 2 female patients who ere vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently both patients fainted. Medical attention was sought, "they were in the office". Both patients recovered "within a few minutes". Attempts are being made to obtain additional identifying information to distinguish individual patients mentioned in this report. Additional information will be provided if available.
The symptoms lasted for about 4 days. My head felt like I had a hat on, I had a chest cough, and I was very tired. The cough didn't go away and I had it for about a week. I felt crappy for a day and a half. I didn't take any antivirals. I took vitamin C, zinc and vitamin D.
Information has been received from a physician concerning a 4-month-old patient who in 2007 was vaccinated PO with the second dose of Rotateq. The physician reported that in October 2007, the patient developed intussusception and was hospitalized. Surgery was performed and the patient subsequently recovered. The physician also considered intussusception to be an other important medical event (surgery). Additional information has been requested.  11/09/2007 Vax record received from PCP and info updated in VAERS database. Lot number for 9/13/07 Rotateq verified as 1116F. 11/28/2007 MR received for DOS 9/24-30/2007 with principal DX:  Intussusception.  2' DX: Transverse colon perforation.  Bilateral Inguinal hernias. Child presented to ED after transfer from local ED with vomiting, diarrhea, no po intake that day and decreased UOP. Concern for IS on US. Attempted reduction of IS by air enema resulted in perforation and pt was taken to OR for an Exploratory lap, reduction of ileocolic Intussusception and repair of transverse colon perforation. Pneumoperitoneum reduced by angiocath. Pt progressed well post-op and was D/cd on POD #6.  01/07/2008 Additional records received for ER visit 10/8/07 with C/o fever and mucusy stools with DX: viral GE.  F/U OV 10/11/07 with c/o diarrhea.  Assessment Viral syndrome s/p Intussusception.
The vaccine was PPV23.  Headache, Chills, fever of 103, vomiting, nauseu, cellulitis.
neuropathy; tingling sensation from the upper arm to the fingers; Hot; Large red area on the left arm; small lump close to the vaccination site; itchy; A spontaneous report was received from a consumer concerning a 84-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a large, red area that was hot and itchy,  small lump close to the vaccination site,neuropathy, a "badness site" in the left arm, with a tingling sensation from the upper arm to the fingers.  The patient's medical history, as provided by the reporter, included seasonal allergy,high blood pressure and high cholesterol. Concomitant medications reported included  high blood pressure medications and simvastatin for high cholesterol.  On 07 Jan 2021 prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 025L20A)) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 02 Feb 2021 the patient received their second  of two planned doses of mRNA-1273 (Lot number: unknown)  in the right arm for prophylaxis of COVID-19 infection  .   On 07 Jan 2021, after receiving vaccination of mRNA-1273,  the patient felt  large, red area that was hot and itchy,  small lump close to the vaccination site,neuropathy, a "badness site" in the left arm, with a tingling sensation from the upper arm to the fingers.  Treatment for the events included  physical therapy to recover the mobility of this arm. Action taken with mRNA-1273 in response to the events was not reported.   The  outcome of the events, a large, red area that was hot and itchy,  small lump close to the vaccination site were considered resolved on 14 Jan 2021 and the outcome of events neuropathy, a "badness site" in the left arm, with a tingling sensation from the upper arm was unknown .; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient is a 82 y.o. female with history of adenocardinoma left lower lobe lung s/p radiation, COPD, nocturnal use of 3 liters oxygen, dementia, eliquis for hx dvt, esophageal stricture who presents today from clinic secondary to hypoxia.  History obtained from daughter bedside and chart review as patient has dementia.  Patient began feeling ill one week ago.  Complains of cough, congestion, wheezing, shortness of breath, mild wheezing, chest discomfort with coughing, fatigue, and decreased energy.  She has had one episode of loose stool.  Denies fevers, chills, loss of taste/smell.  She was evaluated by pulmonology on 5/25 and noted to have oxygen desaturation.  She was recommended to go to the ED for further evaluation however patient refused and preferred home treatment.  She was prescribed Augmentin for possible aspiration pneumonia as well as prednisone taper.  Patient reportedly felt some mild improvement since starting treatment however continued to require use of 3 liters of oxygen during day and night rather than just at night.  She followed up with clinic today where she continued to have oxygen desaturation despite supplemental oxygen and chest xray noted new infiltrate.  She was again recommended to go to the ED for further evaluation and management at which time patient agreed.
Initial information received on 30-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 53 years old male patient who experienced numbing pain in the right arm, specifically small fingers and ring fingers, while he received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Flu Vaccine for Immunization in the left arm. On an unknown date, the patient received a dose of suspect ADACEL lot number not reported via unknown route in the right arm. On 08-Oct-2018, the patient developed a non-serious numbing pain in the right arm, specifically small fingers and ring fingers (Pain in extremity) following the administration of ADACEL. No lab data was reported. Final diagnosis was numbing pain in the right arm, specifically small fingers and ring fingers. It was not reported if the patient received a corrective treatment. The event outcome was Unknown for numbing pain in the right arm, specifically small fingers and ring fingers. List of documents held by sender: none.
no adverse effects; patient received dose of PNEUMOVAX 23 that was improperly stored; This spontaneous report as received from a pharmacist refers to a patient of unknown age. Information concerning his concurrent conditions, pertinent history, allergies and concomitant therapies were not provided.   On 28-SEP-2019, the patient was vaccinated with improperly  stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S012246, expiration date: 10-FEB-2021, dose and route of administration were not provided) for prophylaxis. No adverse effect was reported.   The vaccine underwent temperature excursion: 68 Fahrenheit degrees for 8 hours. There was previous temperature excursion of 68 Fahrenheit degrees for 2 hours. Data logger involved.
I had SOB that worsen my asthma symptoms. I went to the doctor about this.
After receiving the shot, within 15 minutes I began having difficulty breathing.  A doctor was called and after examining me prescribed an epi-pen.  After the injection I was able to breathe normally.
Pfizer/BioNTech Dose Number: 3 14Nov2021/ Treatment of COVID-19 04Jun2022; Pfizer / BioNTech Dose Number: 3 14Nov2021/ Treatment of COVID-19 04Jun2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: "scoliosis" (unspecified if ongoing), notes: Other medical history: scoliosis/ablation for atrial flutter; "ablation for atrial flutter" (unspecified if ongoing), notes: Other medical history: scoliosis/ablation for atrial flutter. Concomitant medication(s) included: CRESTOR, start date: 30Sep2020, stop date: 18Jun2022; VIT D [COLECALCIFEROL]. Past drug history included: Plaquenil, reaction(s): "Known allergies: plaquenil - prolonged qtc", notes: Known allergies: plaquenil - prolonged qtc. The following information was reported: COVID-19 (medically significant) with onset 05Jun2022, outcome "not recovered", described as "Pfizer / BioNTech Dose Number: 3 14Nov2021/ Treatment of COVID-19 04Jun2022"; DRUG INEFFECTIVE (medically significant) with onset 05Jun2022, outcome "not recovered", described as "Pfizer/BioNTech Dose Number: 3 14Nov2021/ Treatment of COVID-19 04Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jun2022) Positive, notes: I tested positive for Covid 19 on the 5th of June. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
6/17/13 mom called reporting 6 hrs after patient received a KINRIX on 6/14/13 she broke out in red blotches all over her body. She was itchy. Blotches on neck, face, legs, stomach, arms. Mom states the arm where KINRIX given was red and itchy, warm to touch. Mom gave 3 doses of BENADRYL in a 24 hrs period and blotchiness resolved. Arm redness and warmth resolved by 6/17/13.
Developed tremors, progressive ataxia, dizziness dx - Opsoclonus Myoclonus.
Information has been received from a nurse practitioner concerning an approximately 2 year old male who on 17-APR-2007 was vaccinated with a first dose dose of ProQuad. On 22-APR-2007 the patient developed more than 100 lesions. The patient's medical status was recovering. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.  10/06/2007 This is in follow-up to report(s) previously submitted on 7/6/2007. Information has been received from a nurse practitioner concerning an approximately 24 month old male with a history of seasonal allergies, who on 17-APR-2006 was vaccinated with a first dose of PROQUAD (Oka/Merck upgrade process) "0044R". One year post vaccination on 24-APR-2007 the patient developed more than 100 vesicular lesions all over the body. No illnesses were reported at the time of the vaccination. No laboratory diagnostics studies performed. The patient recovered on an unspecified date. Additional information is not expected.
Initial unsolicited report received from a physician on 10-AUG-2017.This case involves a 46-year-old male patient who was vaccinated with a dose of MENACTRA (Batch number: U5260AA) (expiry date, dose and dose in series were not reported) and first dose of HEPATITIS A VACCINE (Batch number and expiry date were not reported) via intramuscularly in the right deltoid for both vaccines on 07-AUG-2017. It was also reported that the patient had seasonal allergies. Patient's Illness at time of vaccination and Pre-existing physician diagnosed allergies including other medical history was none. Concomitant medications were not reported. On 07-AUG-2017, same day following the vaccination, the patient experienced a fever of 102 Fahrenheit (38.88 Degree Celsius), myalgia, and nausea. Other laboratory investigations and corrective treatment were not reported. The outcome of all the events was reported as unknown. List of documents held by sender: none.
"Received Tdap developed cellulitis. Treated w/ Motrin PRN." Upon further review, cellulitis very rarely associated with Tdap vaccine but injection site reaction (swelling, redness, tenderness) are very common. Entry into hospital's adverse drug reaction reporting system contains inadequate information to differentiate the presentation and does not include that antibiotics were given to treat as a presumed bacterial cellulitis.
This spontaneous report was received from an office administrator and refers to an unspecified amount of patients (age and gender unknown). The reporter stated that on unknown dates in 2016, the patients received improperly stored doses of RECOMBIVAX HB (lot# M010671, expiration date: 02-JUN-2018, dose and route of administration were not reported). No adverse effects were reported. Temperature excursion occurred on 01-SEP-2016: Temperature: 45F Time frame: 18 hours Digital data logger was involved. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1610USA011550.
The patient is a 61 yo F with hx of DM and HTN presenting to medical center after becoming hypoxic 2/2 COVID-19. She was admitted to MICU for her high supplemental oxygen levels on HFNC. She was extubated and re-intubated on 1/26 after developing laryngeal edema and stridor. She was successfully extubated on 2/6 and transferred to medical floor    #Acute hypoxic respiratory failure  2/2 COVID PNA, improving-- on 2 litre's prior to discharge  - COVID positive on 1/12 - unremarkable ECHO -was intubated at admission due to hypoxia ,  extubated successfully 1/26 but developed laryngeal edema with subsequent stridor and worsening oxygenation status ultimately requiring re-intubation -was given Dex 6 mg q6H for laryngeal edema for 28 hrs (1/26-1/28) - CTPE on 1/18 demonstrated bilateral lower lobe consolidation with GGO's - PAL gram stain notable for rare GPC in pairs and GPR, Cefepime initiated on 1/27 due to concern for infection  -CT chest 1/31 showed no interval change in bilateral multifocal airspace disease, most c/w nonspecific inflammatory alveolitis -CT soft tissue neck on 1/31 remarkable for diffuse hypoattenuation in soft tissues of oral cavity, pharynx, and larynx possibly representing edema. Also showed exophytic soft tissue in medial aspect of R thyroid lobe up to inferior aspect of hyoid bone w/ same enhancement. - complete prednisone taper on 2/19
Pt developed LV thrombus, NSTEMI with LAD lesion, acute R cerebellum stroke shortly after her vaccine, now admitted to HCF for ongoing treatment
Patient was given an expired dose of Menactra with no adverse event; Initial information regarding an unsolicited valid non-serious was received from a Consumer/non-hcp (healthcare professional) via Medical Information (Reference number- 00618521) and transmitted to Sanofi on 27-May-2021.  This case involves a 17 years old female patient who received an 0.5 mL expired dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6596AA and expiry date: 24-May-2021) via unknown route in unknown administration site (expired product administered) for prophylactic vaccination on 27-May-2021.  The patient's medical history, past medical treatments, past vaccinations and family history were not provided.  Concomitant medications included POLIO VACCINE (POLIO VACCINE) and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation.  It was an actual medication error case due to expired vaccine used (latency: same day).  At the time of reporting, the patient experienced no 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 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.
Mother reports today 12/18/07 that baby had reaction to vaccines given on 10/16/07.  Mother states baby cried 2 days, redness of thigh and increased temp 105 for 10 minutes.
broken left hand; itching; raised clear bumps on front of thigh; soreness of the injection site of left arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAND FRACTURE (broken left hand) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Gastrointestinal disorder NOS (Taking meds for "intestinal issues"). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LISINOPRIL, URSODIOL, BUPROPION HYDROCHLORIDE (WELLBUTRIN) and FAMOTIDINE for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced HAND FRACTURE (broken left hand) (seriousness criterion hospitalization) and VACCINATION SITE PAIN (soreness of the injection site of left arm). On an unknown date, the patient experienced PRURITUS (itching) and URTICARIA (raised clear bumps on front of thigh). The patient was hospitalized from 21-Mar-2021 to 22-Mar-2021 due to HAND FRACTURE. On 22-Mar-2021, VACCINATION SITE PAIN (soreness of the injection site of left arm) had resolved. At the time of the report, HAND FRACTURE (broken left hand), PRURITUS (itching) and URTICARIA (raised clear bumps on front of thigh) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment of the events included salve and prednisone.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt's was given wrong dose. He received 0.5mL when he was supposed to get 1mL . I left message on machine to call office back X 2 . If I don't hear back today I will send a letter to have him come in an get the correct dose.
lightheadedness, elevated BP,  hives, wheezing, hot flashes, pressure on chest
Patient received dose #2 of Pfizer vaccine on 6/10/2021 @ ATC Vaccination Services LLC. in Times Square and was notified by email that vial was left in freezer past recommended time frame. Medication expired beyond its freezer allowable date. Email recommended patient get re-vaccinated with dose again. Affiliated Physicians re-administered dose on 6/17/2021 as recommended. No adverse reactions identified on site.
Person received Vaccine injection was ambulatory to observation area became lightheaded dizzy, sat in chair skin pale cool diaphoretic. weak ,radial pulse, initial  V/S   B/P 64/43 HR 114 O2 Sat % 97 RM. air. Pt to stretcher supine color returned to pink warm dry HR decreased to 97 O2 Sat % 98 B/P remains 61/39.  911 called ambulance arrived reassessed person with care taken over and transferred to ED.  Pt states to Ambulance personnel that she was not feeling well today prior to arrival for Vaccine.
Starting a couple of days after the Moderna booster, mild, intermittent tingling, like a graze, no visual rash or symptoms, in the upper right side arm of the side not used for vaccine. Presumed covid arm, intermittently annoying.