chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a female registered nurse who administered Gardasil to a patient. It was reported that after the vaccine was given to the patient, the needle guard device did not work properly to fully cover and protect the needle. Subsequently, the nurse accidentally stuck her hand with the exposed needle which caused bleeding. She sought unspecified medical attention. A number of blood tests were performed, including a test for human immunodeficiency virus (HIV) (results not provided). The HIV test will be repeated in six months. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/16/2007.  Information has been received from a female registered nurse who administered GARDASIL (Lot # 0210U) to a patient.  It was reported that after the vaccine was given to the patient, the needle guard device did not work properly to fully cover and protect the needle.  Subsequently, the nurse accidentally stuck her hand with the exposed needle which caused bleeding.  She sought unspecified medical attention.  A number of blood tests were performed, including a test for human immunodeficiency virus (HIV) (results not provided).  The HIV test will be repeated in six months.  Additional information has been requested.
PT PASSED AWAY WITH COMFORT MEASURES IN PLACE ON 1/8/2022
itchiness on her body; rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness on her body) and RASH (rash) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059h21a) for COVID-19 vaccination.     Concomitant products included GABAPENTIN for an unknown indication.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced PRURITUS (itchiness on her body) and RASH (rash). The patient was treated with CALAMINE for Adverse event, at an unspecified dose and frequency; LORATADINE (CLARITIN [LORATADINE]) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (itchiness on her body) and RASH (rash) was resolving.            It was reported that after 3 days Calamine, Claritin, Benadryl which didn't helped.   This case was linked to MOD-2022-454578 (Patient Link).
Vaccine was out of date by one day. No reaction was noted. A message was left for Vaccine Coordinator at the Health Department which was returned on 08/29/2018.
her chin looks puffier; In between doses she developed itching; rashes; later turned out to be shingles; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 16Mar2021 as single dose for covid-19 immunisation.  Medical history included Allergies. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for Allergies and metformin for unknown indication. On an unspecified date, the patient experienced her chin looks puffier, in between doses she developed itching, rashes and later turned out to be shingles. The patient said that her chin looks puffier and she's asking if it is part of the side effects. Patient had the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE 16Mar2021 - In between doses she developed itching, rashes, and later turned out to be shingles - She went to ENT and dermatologist and diagnosed with shingles - Medications given: Acyclovir taken for 7 days at two times a day, Antibiotics taken for 7 days at two times a day, Prednisone last day was 03Apr2021, second dose schedule will be on 13Apr2021 and asking if she can safely have it. She had the first dose on 16Mar2021 and developed Shingles. The patient was currently on Prednisone and Antibiotics. Caller would like to know if she can get her second dose scheduled on 13Apr2021. Therapeutic measures were taken as a result of in between doses she developed itching, rashes, later turned out to be shingles with Acyclovir taken for 7 days at two times a day, Antibiotics taken for 7 days at two times a day, Prednisone last day was 03Apr2021. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Noticed lump on lower jaw/upper neck area (right side) around 11/21. CT scan on 3/2/22 revealed right parotid tail mass compatible with a primary parotid neoplasm. Biopsy is planned, but has not yet been scheduled. Surgical removal is likely. No other symptoms.
This spontaneous report as received from a nurse refers to a group of patients of unspecified number and demographics. On unknown dates, those patients received doses of improperly stored vaccines: GARDASIL 9 (lot# L037554, expiration date 25-DEC-2017; dose and route of administration were not provided). It was reported that the vaccines were improperly stored for one hour, in the temperature of 33 degrees Fahrenheit. It was reported there was no previous temperature excursion and it was not a case of a "data logger". No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA006077: US-009507513-1702USA006078: US-009507513-1702USA006079:
Unit switched the clip boards and vials from 12 plus vaccine on left side and 5-11 on right side to opposite sides. This writer took the vial on the right which was NOT the one for 12 plus and drew up correct dose of 0.3cc and gave it to the child thinking it was the correct strength. Noted the error at the end of the shift when went to clean the room. Provider informed that evening. Nurse manager and provider informed in am the following day. CDC guidelines reviewed and noted no need to repeat the dose. Nurse manager called pfizer directly for guidance agreed no need to repeat the dose. Parent of the child notified of the error.  THis writer called the State of Immunization Dept and informed how to correctly document the vaccine so that the strength and volume given is noted. VAERS report completed.
patient received the first dose in either April or May, past recommended interval; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient received the first dose in either April or May, past recommended interval) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient received the first dose in either April or May, past recommended interval). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient received the first dose in either April or May, past recommended interval) had resolved.        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.   No concomitant medications were reported.  No treatment information was reported.
Admitted 6/8/2021 for concern unrelated to COVID-19.   Found to be COVID-19 positive >14 days post completion of vaccination series.
Severe facial swelling, rash all over body, itching, numbness, vomiting, achiness; treatment: Prednisone injection and pack, Benadryl.
29jan90 pt vax hepta B after a bite from a hepta b carrier.01feb90 pt developed urticaria and swollen lip.
Swollen lymph nodes Pain in injection site Continued pain in left arm under the injection site Muscular twitching Tendons in both hands contracting
After receiving the vaccine I felt a heaviness in my chest. It would come and go. January 3rd I caught covid. January 17,2021 I went back to work and felt short of breath. Again, it would come and go. On February 13th I went to Hospital?s ER and was admitted with A-fib with fluid around my heart and lungs.  Discharged on February 18, 2022 with a life vest and now need a cardio cath as my heart is weak.
Patient received his flu shot 11/17/22.  On 12/1/22, patient stopped by the pharmacy and said that after he received his flu shot he started having shoulder pain.  Patient said the pain started the day after receiving the vaccine and said that the pain has gradually worsened.  Patient was asked if he thought there was anything else that may have contributed to the pain and he could not think of anything.  Patient was told to follow up with his doctor.  The doctor prescribed a medrol dose pack later that day.
Red, circular rash on left arm surrounding injection site. Raised, hot to the touch, itchy
This spontaneous report was received from a physician referring to a currently 6 year old male patient. Information about the patient's medical history and concurrent conditions was not provided. On 19-MAY-2009, the patient was vaccinated with his first dose of RECOMBIVAX HB, then on 21-JUL-2009 he received the second dose of the series and on 07-DEC-2009 the third one (administration routes, lot numbers and expiration dates were not provided) in MARRS # 1512USA010638.The patient was also vaccinated with a first dose of VAQTA on 20-DEC-2010 and on 01-DEC-2011 with a second one (administration routes, lot numbers and expiration dates were not provided). No concomitant therapies were reported. On an unspecified date, the patient was tested for both VAQTA and RECOMIVAX HB titers, but they were both negative. The physician also reported that the patient developed asthma on an unknown date, after completion of the series of both vaccines. The outcome of hepatitis v surface antibody negative, hepatitis a antibody negative and asthma was reported as not recovered at the time of this report. The reporter did not provide a causality assessment between the events and therapy with VAQTA and RECOMBIVAX HB. Additional information has been requested.
On the morning following the injection, I awoke, feeling okay, went to the kitchen for my omeprazole, and then went into the shower (as usual). After a few minute, I began to feel odd, and thought I was going to faint. I got out of the shower, grabbed a towel, and sat on the closed toilet seat. Next thing I knew, I was on the floor -- don't remember falling or slipping. I felt I couldn't move, but after a few moments, I was able to get myself up, holding on to the counter nearby. I was breathing heavily. Got myself to my bed in the next room, and lay there until I felt able to get up  I don't know how long I was on the floor, because I guess I fainted. I took it easy,and was okay the rest of the day.
An itchy raised rash appeared on my upper arm at site of injection and just below it. The itchiness and rash lasted about 3 -4 days and subsided as the days progressed
pt recv vax & became diaphoretic;rhythm on cardiac monitor was noted to be atrial fibrillation w/ventricular response rate of 180 beats per min;pt had syncopal episode;pt placed in trendelenberg position & given IV fluids & 02;
dry throat; my arm pits started sweating extremely; Left hand was feeling a little heaven; I started having pain in my forearm; my left thigh had  pain and another nodule; my left thigh had  pain and another nodule; This is a spontaneous report from a contactable consumer (patient herself). A 38-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 18Jun2021 01:30 (age at vaccination: 38 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included stroke, clots ,miscarriages and antiphospholipid syndrome. Concomitant medication(s) included levofloxacin (LOVENOX).The patient previously took hydromorphone hcl for hypersensitivity, macrobid [clarithromycin] for hypersensitivity, minocin akne for hypersensitivity, flagyl 250 for hypersensitivity. On 18Jun2021 13:45, the patient experienced dry throat, her arm pits started sweating extremely, left hand was feeling a little heaven, she started having pain in her forearm, her left thigh had pain and another nodule. After 2 mins of taking the first shot she had dry throat, with in 30 mins wait time she experience dry throat, her arm pits started sweating extremely. Left hand was feeling a little heaven that she started having pain in her forearm when she checked there was a dump that was hurting the nurses said it was nothing. But it was hurting she ended up in the emergency room. The doctors explained the nodules are getting inflamed in some people . By 7 pm her left thigh had pain and another nodule. She took Lovenox dose. She still have pain but the nurses and doctors are understanding the pain. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 nor was tested for covid-19 since vaccination. The outcome of all the events was not recovered. The device date was 19Jun2021.
vaccine expired 02/07/2022 observed patient for 30+ minutes with no signs or symptoms of adverse reactions spoke with vaccine technician with GlaxoSmithKline and was advised vaccine still good for 30 days after expiration date. Informed patient the same and emailed all paperwork given form GlaxoSmithKline and the CDC. Advised patient to call if experiencing any adverse symptoms.
Woke up with rash. Right thigh- red and swollen. Left thigh- red pinpoint rash. Afebrile. Seen in ER 7/4/15 treated with IV Rocephin, sent home with Benadryl and Keflex 450mg TID, Prednisone and Motrin. Return to ER 7/6/15 redness on right thigh has increased but swelling decreased. Afebrile.
Information has been received from a licensed practical nurse concerning a 9 year old female patient with urinary tract infection at the time of vaccination and no known drug allergies or pertinent medical history who on 27-APR-2010 was vaccinated with a 0.5 ml first dose of GARDASIL IM (Lot number 662299/1099Y). There was no concomitant medication. On 28-APR-2010 the patient experienced moderate vomiting. The nurse reported that the patient received BACTRIM for urinary tract infection at an emergency room just prior to coming in to the office to get the GARDASIL. No laboratory tests were performed. At the time of the report the patient's outcome was unknown. The patient's mother called the office on 29-APR-2010. The patient sought unspecified medical attention. Additional information has been requested.
No Adverse event; HCP states that they administered 16 shots to patients after their expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No Adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (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 states that they administered 16 shots to patients after their expiration date).    No concomitant medication was reported.   Suspect product dosage text was reported as unknown.  The intact cartons of 0.5 ml of were initially stored in the refrigerator and the thaw dates were the same as administration dates as 01-Sep-2022 ,25-Aug-2022, 04-Aug-2022, 26-Jul-2022 and 19-Jul-2022. The vial did not undergo any temperature excursions.  No treatment medication was reported.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was unknown if patient had any relevant medical history conditions, allergy, concomitant diseases and risk factor.  This case contains information for patient 16 out of 16.   This case was linked to US-MODERNATX, INC.-MOD-2023-739796 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739796:Master case
Four days of extreme soreness and redness around injection site (both doses). Second dose had a fever of 99.6 (normally is 97.5). Not sure if this is related, but four days later I am experiencing pain in my lower lip. It is purple inside and has sores on it. I have never experienced this before.
No Adverse reactions or outcomes. Administered Janssen to 17 years old female patient. observed for first 15 mins no reactions. will follow up with the patient in few days again.
PNEUMONIA; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's was not pregnant at the time of reporting.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-APR-2021, after 45 minutes of vaccination the patient experienced shortness of breathe and chest pain. On MAY-2021, the patient had a computed tomography (CT) scan that shows pneumonia and the patient was under treatment with antibiotics. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pneumonia. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210548936-COVID-19 VACCINE AD26.COV2.S-Pneumonia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Initial Complaint:  Metallic taste.  (Lost sense of smell from a head injury approximately 14 years ago)  3:58  BP 112/68  HR 78  Patient reports metallic taste within minutes of the vaccination.   Did not initially report, but when he did the symptoms were mostly gone.   4:10  BP 110/64  HR 70  Metallic taste patient reported is gone.  Patient reports feeling fine.  No follow up call made...no phone number on the registration form completed by the patient  Recommended the patient remain in observation for 30 minutes when he receives the second dose.
This solicited report received from a consumer (mother), as part of a market research program and referred to a now approximately 8 year old male patient. The patient's concurrent conditions, medical history and allergies, as well as, concomitant therapies were not reported. On unknown date, the patient was vaccinated with GARDASIL (strength, dosage schedule, route, lot number and expiration were not reported). On unknown date, the patient experienced rash (details unspecified). The reporter stated that the side effects seemed unpleasant for her child. The outcome of the event was unknown. The reporter did not provide causality relationship between the event and study therapy. Additional information is not expected because the reporter refused to be contacted.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The medical assistant reported that, on an unknown date, an unspecified number of patients were vaccinated with improperly stored doses of GARDASIL (lot numbers, expiration dates, doses and routes of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pain radiating upward from site of injection to neck, with minor limitation of mobility (unable to lift arm beyond horizontal).
Pt developed urticaria on back,trunk, & legs.Also complains of itching.States has been hoarse for past 3 wks.
It has been 3 days since I received my second shot.  At the site of the shot it is red and the redness is growing around my arm.
Left side swelling to include face, arm, hand, trunk, legs and feet. Noted to be +3 pitting edema.  On 2/5 @ 1307 start having seizure activity that lasted for over 20 minutes. Per hospital policy code blue was called. This resulted in an ER send out.
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 was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), on or about late 2016, for routine health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. On an unspecified date, shortly after receiving the ZOSTAVAX, the patient developed a painful rash. In response to these complaints, the patient presented to a physician and was diagnosed as suffering from the shingles. The onset of the event is unknown. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Patient got vaccine and sat down for observation.  He reports that after 1 minute, he was shakey, sleepy, and very tired.  Then he felt like he fell asleep until the person checking him called at him.  He had some vision and hearing impairment at the beginning, then after 10 minutes he was better. His arm was hot, he was sweating, his skin was turning white color.  His mom came (she was shopping) and said the patient is usually an anxious person, so it was overwhelming to be at department store and getting the shot.  After another 10 minutes, he was drinking water, his senses were back, he was fine.