chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient fainted after receiving 1st GARDASIL injection while leaving office. Alert x3 after using smelling salt. Patient given juice and observed 15 minutes longer. Patient did not eat breakfast day of appt. Patient stable and left office on her own.
After severe confusion, delusion, and paranoia, he was taken to the er.  Encephalopathy, autoimmune and antibody disorders
He is 11 y/o But got the Pfizer Covid Bivalent Booster for 12 y/o and up. Please see enclosed. I believe his symptoms are a continuation and result of his allergies and nose congestion. I am reporting VAERS due to incorrect dose of vaccine being the 12 y/o dose versus 5-11 y/o dose. This report is as of 11/24/22 visits and phone calls as of 11/24/22 I will continue to monitor.
10.5 CM X 11.5 CM area of local reaction- redness with underlying in duration warmth to touch and tender to touch (No systemic associated fever- 98.1 F Tympanic- on evaluation 2 days post vaccination administration).
Narrative: 09:58am;COVID-19 vaccine given 10:15am reported scratchy throat and dizziness to RN observing. 10:17am: called COVID covering PCP for continued symptoms. Patient admits that she did take Benadryl and expired EPI pen after 1st dose du to swelling in the mouth. She didn't mention prior to getting her vaccine today. 10:19am: Dr to COVID obs room for evaluation. 10:20am: Epinephrine autoinjector given to right thigh per Dr verbal order. 10:21am: 135/74 HR:110 PO2:99% on RA 10:22am: Benadryl oral 25mg/10ml liquid given. 10:23am: States throat is starting to feel better. 10:30am: Moved back to observation room and PCP request 30 min more of observation. 10:35am: Patient to report to ED with spouse for continued observation. 10:40am: RN Team4 takes patient upstairs to meet with husband and report directly to ED. Left observation rom in no acute distress.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 10:44 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 10:44 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 43.25.  Concomitant products were not provided.  Excursion time was 09 AM and 10 AM, with temperature as 29, and 32 respectively. Total doses given for the day was 116. Condition of vaccine prior to administration was not frozen. 9 AM vaccine was moved to fridge on 29-sep-2021 and 10 Am vials on 05-Oct-2021. Vial was moved to clinic on 27-oct-2021. 2 vials from 9 AM and 4 vials from 10 AM were sent to clinic. Vaccine BUD date was 29-oct-2021 for 9AM,and 04-Nov-2022 for 10 AM respectively.  On 27-oct-2021, no hourly temperature recordings available  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Patient experienced chills, fatigue, headache on 6/10/21.  On 6/11/21 she experienced shortness of breath, chest pain, and "feeling like she was going to die". Symptoms resolved by the following day. Suspect myocarditis.
Severe ringing in ears for 12 hours, then slightly quieter. Tinnitus diagnosis per my ENT doctor. Ringing is 24/7 - no change since April 2021. Extremely frustrating.
Approximately 10 minutes after vaccine administered, pt felt nauseated and hot and had syncopal episode. Pt "woke Up" drenched in sweat.
PATIENT HAD SIGNIFICANT UNILATERAL SUB-CENTIMETER LEFT ANTERIOR CHAIN AND ONE CENTIMETER LEFT LOWER CHAIN AND SUPRACLAVICULAR LYMPHADENOPATHY THREE DAYS AFTER VACCINATION IN THE LEFT DELTOID MUSCLE.  THESE WERE FULLY MOBILE NODES WITHOUT MATTING.  LYMPHADENOPATHY RESOLVED WITHIN 17 DAYS OF VACCINATION.
PFIZER COVID VACCINE #3 GIVEN 11/15/21, LOT #30155BA; pt had a positive COVID test (out patient) on 1/10/22; he saw his PCP and was given Augmentin and Prednisone; did not improve, worsened; 1/12/2022 pt to ED via EMS for SOB, hypoxia, generalized weakness, cough, diarrhea; started on BiPAP in ED; in renal failure; sent to ICU; experienced respiratory arrest and was intubated; extremely poor prognosis; family made pt a DNR C; pt expired in the hospital
Information has been received from a consumer via Market research referring to her/his friend's daughter, a 13 year old female patient. The patient's concurrent condition included lead poisoning. On an unknown date in 2000 the patient was vaccinated with the first dose of GARDASIL (strength, dose, route, lot # and expiration date were unknown). On an unknown date the patient experienced pain which lasted a week and she was in bed for a week after GARDASIL injection. Therapy with GARDASIL was reported as interrupted and the patient did not get the second dose. The outcome of pain was reported as recovered/resolved on an unknown date in 2000, and did not appeared again. The reporter considered pain to be related to GARDASIL. It was reported none of the other friends chose to take GARDASIL because of these staked events. The reporter considered the event was serious due to the patient was in bed for a week. This is one of two cases received from the same reporter. Additional information has been requested.
SHE RECEIVED THE VACCINE ON 4/8/2021. SHE COMPLAINED ABOUT A POSSIBLE SIDE EFFECT TO ME ON 4/13/2021. ACCORDING TO HER, SHE STARTED TO HAVE PAIN IN THE BACK OF HER THIGH (CLOSE TO HER BUTT)  ON 4/9/2021.  SHE SAID THE PAIN IS STILL ONGOING. I TOLD HER TO SEEK MEDICAL SUPPORT (SEE A DOCTOR). ON 4/15/2021 SHE SAID SHE NO LONGER HAS PAIN IN HER THIGH. SHE SAID SHE TOOK BABY ASPIRIN PER HER PRESCRIBER (APRN).
Hive like rash over entire body lasting 3 days. Chills "flu like symptoms" Took Benadryl x 3 days after talking to physician via telephone. s/s gone after 3 days.
neck remains sore; Felt a real pressure on the left side of neck, like tightening on the artery, restraining, constricting; Felt a real pressure on left side of neck; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck remains sore), MUSCLE TIGHTNESS (Felt a real pressure on the left side of neck, like tightening on the artery, restraining, constricting) and DISCOMFORT (Felt a real pressure on left side of neck) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021 at 2:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced NECK PAIN (neck remains sore), MUSCLE TIGHTNESS (Felt a real pressure on the left side of neck, like tightening on the artery, restraining, constricting) and DISCOMFORT (Felt a real pressure on left side of neck). On 20-Apr-2021, MUSCLE TIGHTNESS (Felt a real pressure on the left side of neck, like tightening on the artery, restraining, constricting) and DISCOMFORT (Felt a real pressure on left side of neck) had resolved. At the time of the report, NECK PAIN (neck remains sore) outcome was unknown.            A male consumer reported that he received his second dose of the vaccine on 20-Apr-2021 around 2 p.m. and that during the 15 minute observation time, he felt a "real pressure on the left side of his neck, like tightening on the artery as an outcome(?)", it was restraining, constricting and sore for a few minutes and subsided a little after 15 minutes, however, his neck remained sore for the rest of the day.   Concomitant product use and treatment information was not provided.     This case was linked to US-MODERNATX, INC.-MOD-2021-081752 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081752:First Dose
A few minutes after giving vaccination, patient's mother and caregiver stated that he was having a reaction.  Patient can only use his eyes to respond "yes" or "no" since he is non-verbal and when he would not respond to his mother's questions with his eyes she became very panicked and alerted the pharmacy staff.  When I got to the patient he was very clammy, sweating, and breathing heavy.  She said his eyes had rolled back in his head and his tongue had turned blue.  I propped his legs up on a chair and took his blood pressure with an automatic blood pressure cuff and it was 164/124 with pulse 95.  I decided to contact EMS for assistance. Retook BP  few minutes later and it was the same.  EMS arrived and stated it was most likely a reaction to being afraid of needles but would take him to get checked out.
Sore arm; Patient received his first shot on 2Jan2021 and he received another shot on 13Apr2021; Aching body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received his first shot on 2Jan2021 and he received another shot on 13Apr2021) and MYALGIA (Aching body) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received his first shot on 2Jan2021 and he received another shot on 13Apr2021) and MYALGIA (Aching body). At the time of the report, PAIN IN EXTREMITY (Sore arm) and MYALGIA (Aching body) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received his first shot on 2Jan2021 and he received another shot on 13Apr2021) had resolved. Not Provided          No relevant concomitant product use was reported.  No treatment details were provided.
Cough feeling like bronchitis developed along with fever and chills at approximately 11 hours post dose and has persisted with improvement for 72 hours. Covid testing completed on day 3 (due to concern about cough symptoms) was negative.
Severe itching all over body; no rash however.   Benadryl orally.  Lasted 2 days so far
pt exp flu-like sx coincident w/the administration of flu inj; these sx began approx 1 to 2 days p/vax;
Extreme knee joint pain that began a few hours after her Covid vaccine in January and again in February with her second injection. Patient states that she started having the severe leg pain and cramps a few hours after her first and then her second Covid vaccine. Patient states that the severe pain lasted for a few days and her knees and then went to her hips her back. Patient states that she at one time was not able to do anything that she would normally do. Patient states that she typically would walk miles a day every day and was not able to do this for the first couple of months
a friend had suspicious cells in a pap smear and unsure if was HPV related; a friend had suspicious cells in a pap smear and unsure if was HPV related; This spontaneous report has been received from a physician or consumer (reported as unsure whether the podcast host or doctor), via a company representative) on a podcast, regarding a female patient of unknown age. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, as prophylaxis (strength, dose, frequency, route and anatomical location of administration, lot number and expiration date were not reported).   On an unreported date, the patient's pap smear presented suspicious cells (Smear cervix abnormal), it was also stated it was unsure if it was related to human papilloma virus (HPV) (Papilloma viral infection). The outcome of the events was not reported.  The causal relationship between the aforementioned events and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not reported.
Raised, red area sensitive to touch surrounded by erythematous skin; discomfort in arm.
Fever, nausea, vomiting, diarrhea, fatigue all starting on 21 Feb 2022.  Fever, diarrhea and fatigue ended on 24 Feb 2022.
Brought to hospital on 9/8 due to acute hypoxic respiratory failured secondary to pneumonia and empyema. Intubated with +COVID test.  Recent hx of  trauma incolcing rib fractures and hemothorax. Left-sided thoracostomy tube placed and admitted to ICU.  Palliative care was consulted to clarify goals. Infectious disease consulted due to MRSA empyema  that led to bacteremia. Noted to have worsening right knee wound and right sided septic arthritis with infected hardware from prior arthroplasty. Orthopedic performed right above knee ampoutation on 9/24. On 9/30 family opted for comfort care.
Extreme pain at vaccine site and limited mobility of the arm for approximately 48 hours. Gradually decreased with a treatment of ice, ibuprofen, tylenol, and cyclobenzaprine. By the 4th day i was free of pain and had full mobility in my arm.
This case was reported by a consumer and described the occurrence of yellow skin in a 46 yr old female subject who was vaccinated with hep A inactivated and hep B recombinant vaccine (Twinrix) for prophylaxis. The reporter is the subject. A physician or other health care professional has not verified this report. Medical history included a diagnosis of hep C. On 11Aug05 the subject received 1st dose of Twinrix. On 11Sept05, 31 days after vaccination with Twinrix, the subject experienced yellow skin. The subject was seen at a physician's office. The yellow skin was ongoing at the time of initial reporting, 26Oct05. Yellow skin was assessed as medically serious by manf (OMIC).
Father reported age as 3 yrs. Given 0.5 ml FLUZONE rather than 0.25 ml. According to records patient is 2 yrs, 9 mos. Child wt. - 40 pounds 10 oz.
Hard, painful lump at PNEUMOVAX injection site. Fevers, body aches, redness at injection site. Induration at injection site.
Patient was administered Pfizer on 9/10 as first dose and on 10/1 was administered Janssen as second dose in error.  No adverse reaction at this time
urticarial spotty eruptions on the upper part of both arms and says his leg is very sore where he was given the Prevnar 13 vaccine .  He vomited large amounts
DIFFICULTY SLEEPING; ITCHING; PAIN; SORES ON SKIN; SKIN WAS SLOUGHING OFF; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced difficulty sleeping, itching, pain, sores on skin, and skin was sloughing off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the difficulty sleeping, itching, pain, sores on skin and skin was sloughing off was not reported. This report was non-serious.
Patient received Fluad vaccine 1 week prior to this administration.  Patient made aware.  No adverse effects.
highly agitated; irritable; makes them want to kill somebody, heightens their system; aches; arm is still red; body chills; This spontaneous case was reported by a patient and describes the occurrence of AGITATION (highly agitated), IRRITABILITY (irritable), FEELING ABNORMAL (makes them want to kill somebody, heightens their system), PAIN (aches) and VACCINATION SITE ERYTHEMA (arm is still red) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In September 2022, the patient experienced AGITATION (highly agitated), IRRITABILITY (irritable), FEELING ABNORMAL (makes them want to kill somebody, heightens their system), PAIN (aches), VACCINATION SITE ERYTHEMA (arm is still red) and CHILLS (body chills). At the time of the report, AGITATION (highly agitated), IRRITABILITY (irritable), FEELING ABNORMAL (makes them want to kill somebody, heightens their system), PAIN (aches) and CHILLS (body chills) outcome was unknown and VACCINATION SITE ERYTHEMA (arm is still red) had not resolved.            No Concomitant medications were provided. On 10 Feb 2021 patient received first dose of Moderna vaccine with lot number information was not provided. On 17 Mar 2021, patient received second dose of Moderna vaccine with lot number information was not provided. On 29 Oct 2021 patient received third dose (first booster dose) of Moderna vaccine with lot number as 939905.  It was reported that patient gotten highly agitated and irritable after getting the Moderna bivalent (second) booster dose last Friday, 23 Sep 2022. Patient state that it was the same kind of reaction patient get when take Sudafed. Makes want to kill somebody and heightens system. Patient also had the aches, body chills and arm was still red.  No treatment medications were provided   Reporter did not allow further contact
A pediatric dose of Pfizer (0.2mL) accidentally administered to a 12-year-old.
Immunized with Varivax 09-09-96 had chicken pox 03-01-04.
Fever of 101.3, sweats, chills through the night, early morning fever broke. No fever in AM.  Took a hot bath and feel much better.  Still a little out of balance but not enough to go to Doctor.
The left side of my lip began to twitch, then my lips went completely tingly and numb, my face went numb, and I became a little bit disoriented while driving home. I also noted a pain in the left side of my chest. I got feeling back in my lips in my face approximately half an hour to 45 minutes later.  I did take an Allegra allergy pill when I got home. I had already taken one Allegra allergy pill that morning. I slept for 12 hours on the following Friday night and Sunday night, whereas I typically only sleep approximately 6 to 7 hours per night. I noted significant stuffy nose and fatigue for the 3 to 4 days following the vaccine continuing until today.
Onset of fever 06/15/2005 at 1800, Mom found child unresponsive but breathing at 2200.  Described by Mom as stiff legs and arms with slight drooling.  EMT's called.
developed a rash on my upper abdomen; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-Aug-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient developed a rash on my upper abdomen. The patient asked if this could be a side effect of the shingles shot. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Patient got a black bruise at injection site. There was inflammation at injection site which subsided within 48 hours but the bruise remained.  Patient said there was no pain as inflammation subsided but the black bruise remained even after 5 days.
Soon after she got to work after getting her shots, she experienced increased heart rate and blood pressure.  Called EMTs, took her to ER.  They gave her a medication "Prezone' that decreased HR and BP.  Sent home.  Later, got fever of 103 degrees, called EMTs.  One time she threw up blood.  Client was unreliable as to the exact information.  She called today, 1/18/2010 to report the incident, claiming increased heart rate.  Was told to seek medical help.  Later she called that she had no transportation to the doctor.  Was again told to get medical help however she can.
27 years old patient received rabies vaccine in left thigh; Initial information received on 31-May-2019 regarding an unsolicited valid non-serious case received from other health care professional.  This case involves a 27 years old female patient who received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included RABIES IMMUNEGLOBULIN (RABIES IMMUNEGLOBULIN).   On an unknown date, the patient received a dose of suspect RABIES (HDC) VACCINE lot number not reported via intramuscular route in the left thigh.  It was an actual medication error due to vaccine administered at inappropriate site.  It was reported that 27 years old patient received rabies vaccine in left thigh.  It was unknown whether patient experienced any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on Batch number was requested.  List of documents held by sender: none.
Pt. received vaccination in L deltoid. Never received flu vaccine before. Believed that immunization only made it to adipose tissue and not to muscle due to concentrated adipose tissue in upper arm. Pt. experience tingling and numbing in L arm due to reaction from adipose tissue.
patient called on 10/28 reporting of pain and swelling in left arm to her hand. Patient was advised to take benadryl, acetaminophen and to ice the injection site area.