chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse and refers to a male patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On 07-SEP-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # L007720, expiration date: 08-JUL-2016; dose and route of administration were not reported). No adverse effects were reported. Additional information is not expected as there was no consent to contact the physician.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On an unknown dates, the patient was vaccinated with first two doses of GARDASIL. On an unknown date, the patient turned 27 years old. On 16-MAR-2015, the patient presented to the office for third dose of GARDASIL (Inappropriate schedule of drug administration). No adverse effects were reported. No product quality complaint was reported for GARDASIL. Additional information is not expected as the reporter did not wish to contact.
Pt was given adult dose instead of pediatric dose. Pt's mother stated they are not having any symptoms.
ER Note:  17 y/o with no prior significant medical history presented  to ER with onset 6/20 am of chest pain.  None exertional, constant, or aggravating or relieving factors, not associated with any palpitations, breathing difficulty, dizziness, or syncope .  No fever.  Feels well generally.  Cardiologist consulted for concern of COVID vaccine induced myocarditis.  Admitted
Tension headache still lasting at day 11 has not improved and works past pain meds. Also taking muscle relaxants and my daily escitalopram and emergency meds lexapro
Pt had T noc of 10Mar91-11Mar91 of 102.Fever during day 100 saw MD on 13Mar91.Mom states MD said"throat&ears were clear".Mom states child has"stuffy"nose,also saw small blood clot from nose.Has no rash.Given Rondec DM gtts(oral).
Dizzy; Blurred vision; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3246; Expiration date was not reported) on 29Jan2021 (10:45) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization at the Public Health Department. Medical history included hypertension (HTN), atrial fibrillation (Afib), diabetes mellitus (DM), migraine and sulfa drug allergy. Concomitant medications included dabigatran etexilate mesilate (PRADAXA), metoprolol, montelukast sodium (SINGULAIR) and other unspecified medications. The patient previously took clarithromycin (MACROBID), and had allergies; and had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3246; Expiration date was not reported) on 08Jan2021 (when the patient was 74 years old) on the right arm for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 29Jan2021 (21:00), the patient was dizzy; and had blurred vision. The patient did not receive any treatment for the reported events. The outcome of the events, 'dizzy' and 'blurred vision', was recovering. The patient was diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination.
No adverse effect; the patient received the first dose of PROQUAD on 25-APR-2018, and was inadvently administered a second dose of PROQUAD on 07-AUG-2019; the patient was inadvently administered a second dose of PROQUAD on 07-AUG-2019/mother did not disclose patient had been to another office, we gave PROQUAD then found out after patient left she had been seen elsewhere last year; Information has been received from an office manager referring to a 69 months old female patient. No information on patient's pertinent medical history, concomitant medications, drug reaction or allergies was provided.  On 25-APR-2018, approximately at the patient's age of 53 months old, the patient was vaccinated with the first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # S002926, expiration date 28-JUL-2020 (possibly incorrect information provided from reporter, as the patient received the second dose with the same lot#), anatomical location was right vastus lateralis, dose and route of administration were not provided) for prophylaxis. On 07-AUG-2019, the patient was inadvertently administered a second dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # S002926, expiration date 28-JUL-2020, anatomical location, dose and route of administration were not provided) for prophylaxis. After the patient left, it was found out that she had been seen elsewhere last year (inappropriate schedule of product administration, product prescribing issue). The patient's mother did not disclose that the patient had been to another office previously. No adverse effects were reported. The patient had no illness at time of vaccination. No temperature excursion occurred as a result of a reading from a digital data logger. There was no prescription drug treatment for the experience required.
hives mom reported w/in 18 to 20hr gone w/on 48hr;MD gave an antihistamine rx & mom said no further problems;
Immunization  1/15/2021 COVID Vaccine Clinic Need for vaccination +1 more Dx Medication Reaction ; Referred by MD Reason for Visit Progress Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosign Needed Expand All Collapse All    COVID VACCINE CLINIC 1/15/2021       Subjective Patient is a 19 y.o. male who was seen at COVID Vaccine Clinic today for his first dose of the COVID 19 vaccination.    He denied any history of previous adverse reactions to vaccines.   He was given the Moderna vaccination in the left deltoid muscle.   During his 15 minute waiting period after the injection, the patient began to experience tired and stomach upset.  He denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and he was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting.     ALLERGY REVIEW OF SYSTEMS:  Patient complains of malaise/fatigue and dizziness   Patient denies chills, fever, vomiting and abdominal pain    Nausea:     Previous Reactions: Reports similar symptoms with other vaccines in the past but no major reactions.     Objective    Vitals Vitals:   01/15/21 1334 BP: 126/89 Pulse: 75 SpO2: 99%   Patient ate about 15-20  Minutes prior to coming to appointment   Physical Exam Constitutional:      Appearance: Normal appearance. He is not ill-appearing.  Cardiovascular:     Rate and Rhythm: Normal rate.  Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.  Abdominal:     General: There is no distension.     Tenderness: There is no abdominal tenderness.  Skin:    General: Skin is warm and dry.  Neurological:     Mental Status: He is alert and oriented to person, place, and time.        Assessment/Plan  Treatment included: no therapy. Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP.   Overall stable. Patient states he has this same reaction with other vaccines including his annual flu vaccine. Feels nauseous and really tired. States he generally goes home and is able to "sleep it off". Declines Pepcid today. Overall he feels stable. No progression of symptoms and nausea has actually improved after drinking some water.   APRN Electronically Signed 1/15/2021 1:42 PM
Presented w/ SOB, tested covid+ 3 days prior. Worsening sx, HTN. Tx w/ zinc, dexamethasone.
After 10 minutes after injection, patient felt cold, light headed. Patient had a pale look in the face and skin was clammy. The pharmacist dialed 911. The paramedics arrived approximately 2:20pm. They accessed patient and patient refused to be taken to the hospital. Patient never lost consciousness.
CONFIRMED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a consumer concerned a male of unspecified age, race and ethnicity. Initial information was processed along with the additional information received on 19-OCT-2022. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). On an unspecified date, the patient received non-company suspect vaccine elasomeran (Moderna covid-19 vaccine) (Dose number in series 2) (form of admin, route of admin, and batch number and expiry were not reported), dose, start therapy date were not reported for covid-19 prophylaxis. On an unspecified date, the patient experienced covid rebound started with coughing, sneezing, runny nose and symptoms were fever, chills, significant joint pain, and fatigue. The rebound is diarrhea, upper and lower colds (confirmed covid-19 infection) (Dose number in series 2) and had revaccination with different covid-19 vaccine (Dose number in series 2). Laboratory data (dates unspecified) included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The outcome of the confirmed covid-19 infection and revaccination with different covid-19 vaccine was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000255909.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
2 day tactile temp/brought to ER 10/28/02 for intractable vomiting. Admitted hospital for exacerbation asthma, ? of RLL pneumonia, vomiting/discharged 10/31/02/treated with oxygen, IV fluids, IV Ceftriaxone, Phenergan supp. oral amoxicillin.
Swelling, pain, redness, warmth, & stiffness at site of injection. Pt given cephalexin 500mg TID for 10 days.
Redness, edema, warmth/hot to touch area also w/lump per pt.
-Fever of 102.1 degrees at 3am -Migraine lasting 12+ hours with lingering effects -migraine induced vomiting at 5:30am and 8am the day after vaccination -Extreme chills at from 11pm to 1am starting on the day of vaccination
Pt recvd MMR on 06APR90; 2 wks later pt devel chest pain, tiredness, muscle weakness & polymyositis; Lab eval revealed CPK 15,000; tx steroids;
shot give 1600 06/10/2004 06/10/04 2020 infant grunting, color grey, mottled hr 120, no murmur noted 06/10/04 unable to get temp , extremities cold (infant in warmer)  pupils dialted no HR - on strip shows skipping heart beat CXR:cardiomegaly 6/10/04 22:10 newborn died  Nurse follow up on 06/18/04 states: "unresponsive, tachycardia, respiratory distress, regurgitation."  Nurse follow up on 08/02/04 states: "Hypoplastic left heart complex."
Child received 4th vax, 10-15 minutes later child developed blotchy red rash, a few scattered hives on trunk. Bilateral decrease forearms red, edematous. Child playful, alert, BBS-C1. D/C with steroids, mom reports that child had hives with 1st vax, but received 2 doses after that without problems.
Narrative: COVID infection following COVID vaccine series *04/03, Pfizer, dose #1 (non-Facility) 04/24, Pfizer, dose #2 (non-Facility) 09/16 COVID swab, result: detected 09/15 pt cc: cough, diarrhea, rhinorrhea exposure: husband
vaccine itch; This is a spontaneous report from a non-contactable consumer via Pfizer-sponsored program. A patient of unspecified age and gender received bnt162b2 (Pfizer Covid-19 Vaccine, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as UNKNOWN,SINGLE for covid-19 immunisation.The patient medical history and concomitant medications were not reported. The patient experienced vaccine itch on an unspecified date. The outcome of the event itchy was unknown.  No follow-up attempts are possible; Information about batch/lot number cannot be obtained. No further information is expected.
Patient received COVID vaccine and approximately 15 minutes later she was reporting itchiness and nausea.
Hives on face, ears, arms and legs; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 18Apr2021 at 13:15 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. The patient did not have relevant medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications within two weeks prior to vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 28Mar2021 at 12:45 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. On 02May2021, two weeks after the second dose of vaccination, the patient experienced hives on the face, ears and later spread to arms and legs. The event resulted in doctor or other healthcare professional office/clinic visits. Therapeutic measures were taken as a result of hives on the face, ears, arms and legs which included treatment with prednisone steroid (MANUFACTURER UNKNOWN) from an unknown date and unknown if ongoing. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event hives on face, ears, arms and legs was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
expired dose administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 20-year-old female patient who received HAV (Havrix 1440) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th June 2022, the patient received the 1st dose of Havrix 1440 and Havrix Pre-Filled Syringe Device. On 29th June 2022, unknown after receiving Havrix 1440 and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 30-JUN-2022 Reporter's comment: The nurse/ practice manager reported that the patient received an expired Havrix dose. The reporter consented to follow-up via post. Additional Supportive Information: The patient received a dose of Havrix vaccine which was already expired, which led to expired vaccine used.
Hives, rash, unrelenting itching began Friday evening. By Saturday morning fully covering my body and hasn't stopped since. On a heavy fucking dose of steroids, benadryl, and doxepin to make my nerves feel nothing. Full course of steroids and it is still showing up in random places. Appears, dissipates, appears again.
1) 4 in x 3.5 in swelling/redness/warmth in left upper arm.
Muscle tenderness on 07/01/2020.  Right upper arm swelling, erythema covering approximately 2/3 of upper arm on 07/02/2020 Slight reduction in swelling and erythema on 07/03//2020 with onset of itching.
318 patients received dose from vials beyond 30-day use by date; 318 patients received dose from vials beyond 30-day use by date ( In Refrigeration on 07-May-2021); This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (318 patients received dose from vials beyond 30-day use by date ( In Refrigeration on 07-May-2021)) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (318 patients received dose from vials beyond 30-day use by date ( In Refrigeration on 07-May-2021)). On 11-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (318 patients received dose from vials beyond 30-day use by date ( In Refrigeration on 07-May-2021)) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-363757 (Patient Link).
This spontaneous report was received from a physician concerning a 68 year old male patient with hypertension, stage 3 chronic kidney disease and type 2 diabetes. The patient's medical history included stroke and prostate cancer. On 05-JAN-2009, the patient was vaccinated with a dose of ZOSTAVAX (dose, dose number, lot number, expiration date and route were not reported). Physician reported patient received ZOSTAVAX in 05-JAN-2009, and now had a "breat out" of zoster on 13-OCT-2014. At the time of the report the outcome was reported as not recovered. Patient received treatment with VALTREX and sought medical attention. None lab test diagnostics were performed. Additional information has been requested.
This spontaneous report was received from the registered nurse regarding a 16 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 28-AUG-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
Patient was given vaccination (ZOSTAVAX) on 10-12-2013 at pharmacy. Patient developed cellulitis and received antibiotic injections (in MD office) and was prescribed oral antibiotic (given oral antibiotic 10-18-2013). Patient went to MD on October 15th, 16th, 17th, and 18th.
This case was reported by a nurse via call center representative and described the occurrence of injection site induration in a 18-year-old female patient who received BEXSERO (batch number 151401A, expiry date 31st December 2016). On 21st June 2016, the patient received BEXSERO .5ml. In June 2016, less than a week after receiving BEXSERO, the patient experienced injection site induration, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site induration, injection site swelling and injection site warmth were unknown. It was unknown if the reporter considered the injection site induration, injection site swelling and injection site warmth to be related to BEXSERO.  Additional details were provided as follows: The patient received a dose of BEXSERO vaccine in her left arm and experienced warmth, firmness, and swelling at the injection site. The healthcare professional stated that, the symptoms had no subsided.
In 7/99, the pt received his 1st dose of Lymerix, with no ill effects. In 8/99, he received the 2nd dose. After about 4 months, in 12/99, he experienced a "dull ache-like chest pain under his left breast". He also had palpitations and tachycardia. It was reported, these episodes had a sudden onset and were unrelated to activity. They were infrequent and usually occurred in the AM but have occurred over the course of the day. During the episodes, the pt reported feeling faint and had a "very strange and unusual feeling of fatigue". The pt saw his PCP in 12/99. In 2/00, the pt saw his PCP again and he prescribed Xanax for anxiety. The pt did not believe he felt anxiety in 12/99 or 7/00 and did not use the Xanax very often, rarely if he felt anxiety. The pt received the 3rd dose of Lymerix in 8/00. The most recent information received on 8/16/00, reported the symptoms were ongoing. The last episode was in 7/00. Follow up on 12/01/2000: "Physician stated, on 12/13/1999 the patient developed transient sweating and palpitations.  He remained asymptomatic until 12/25/1999, when he had three subsequent episodes lasting 15-30 minutes and two more episodes on each of sucessive days.  He was examined on 12/28/1999 and was normal except for a blood pressure of 158-83.  A 24 hour Holter monitor was obtained and revealed no abnormality except brief episodes of sinus tachycardia.  A fasting blood glucose, thyroid panel, and complete blood count were normal.  The patient was diagnosed with panic disorder and was treated with alprazolem as needed.  The most recent information received on 11/21/2000 did not provide an outcome.  Causality per patients physician: "I have advised the patient that I have no reason to believe that his symptoms are in any way related to his Lymerix vaccine".  Follow up on 02/02/2001: "The events of "feeling faint" and "panic disorder" do not meet ICH serious criteria, but are being submitted as an expedited report by special request per the 06/28/2000 letter.  The initial section of this report was submitted on 08/29/2000."
On 11/22/99, the pt experienced one mark on her wrist and five on her face. They looked like little whitehead marks. One was scabbed. She thought the first one was a bug bite. She experienced the most marks on 11/29/99.
Information has been received from a licensed practical nurse concerning a 15-month-old female who on 24-Mar-2003 was vaccinated with a dose of varicella virus vaccine live (Lot #542676/0421M). On 03-Apr-2003 the child presented to the doctor's office with a generalized rash, described as being mostly on her chest and back, but some on her face, arms, and and legs. It was noted that the child has "no fever now", but the mother of the child stated the child had a fever up to 102 degrees on 01-Apr-2003, "two nights ago". No treatment was prescribed. Unspecified medical attention was sought. The reporter indicated that one other patient was vaccinated with a dose of varicella virus vaccine line and developed a generalized rash and a fever (WAES #0304USA00366). No further information is expected.