chrisvoncsefalvay/vaers-outcomes huggingface dataset:
enlarged testicles; The patient just got the booster shot of the Pfizer covid vaccine 2 days ago and now he has enlarged testicles; The patient just got the booster shot of the Pfizer covid vaccine 2 days ago and now he has enlarged testicles; Soreness in his arm; This is a spontaneous report from a contactable consumer (Caller is a consumer calling on behalf of his father) or other non hcp.  An 87-year-old male patient received booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm on 20Sep2021 08:45, (Age at vaccination: 87 years old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Medical history included lost his ability to swallow and hypothyroidism from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine 50-75 mcg, it varies by day taken for an unspecified indication, start and stop date were not reported; apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number, Expiry date: not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number, Expiry date: not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. On 20Sep2021 Monday, the patient just got the booster shot of the pfizer covid vaccine 2 days ago and now he has enlarged testicles (extra dose administered (booster), off label use). On Tuesday, 21Sep2021, the patient experienced swollen enlarged testicles, soreness in his arm on an unspecified date in Sep2021. The outcome of the events enlarged testicles and soreness in his arms was unknown.  Follow-up (24Sep2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  Follow-up (24Sep2021): New information received from a same contactable consumer reported for a patient (father) included: Vaccination date updated, onset date for event updated.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Guillain Barre after taking the dpt booster; Paralyzed; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant) and paralysis (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome and paralysis were unknown.   It was unknown if the reporter considered the guillain barre syndrome and paralysis to be related to DTPa vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient took the DPT booster shot. The patient got Guillen Barre and was paralyzed. The patient was still recuperating after nine months and advised that, the Whooping Cough vaccine should be get with caution.
Patient received the covid vaccine on 12/23/2020. She reported that she had chills (temp was 98.0), sore throat, nasal congestion, sneezing, started on 12/25/2020. Chills (shivering lasted for 1 day and "broke out in sweats").  Still has sore throat., stuffy nose, sneezing as of 12/28/2020. Denies rhinorrhea, cough, or fever.  Had negative covid test on 12/28/2020.
No additional adverse effects reports; one male patient was administered improperly stored ROTATEQ; Information has been received from a vaccine coordinator referring to a 7 months old male patient. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not provided.      On 25-FEB-2020, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (oral; lot number 1658255, expiration date 07-FEB-2021; strength, dose and frequency unknown) for prophylaxis (product storage error).   The storage temperature of the vaccine was above 9 degree Celsius (9.3 degree Celsius) for a time frame of 3 hours 33 minutes on 25-FEB-2020. It was also reported that the storage temperature was below 2 degree Celsius (0.8 degree Celsius) for 5 hours 9 minutes on 02-MAR-2020, below 2 degree Celsius (0.8 degree Celsius) for 11 hours 39 minutes on 03-MAR-2020, below 2 degree Celsius (0.9 degree Celsius) for 11 hours on 04-MAR-2020 and below 2 degree Celsius (-1.3 degree Celsius) for 9 hours and 29 minutes on 05-MAR-2020. The call was because of a data logger. No additional adverse effects were reported.
Pruritic rash occurring after vaccine was administered. Pt not allergic to eggs and did not eat any new foods or medications.
headache all over head, so very tired, body sore, do not want anything to eat.
Pt called into doctor's office on Monday 6/28 to report persistent fever, nausea, mouth sores and severe headache 7/10, as well as blurry vision. RN advised pt to go to ED for further eval of symptoms and she agreed to disposition.
Very itchy; A rash on her entire body; A sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (A sore arm), PRURITUS (Very itchy) and RASH (A rash on her entire body) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 031L20A) for COVID-19 vaccination.     Concomitant products included VALSARTAN, SIMVASTATIN, LIOTHYRONINE, LEVOTHYROXINE and ALENDRONATE SODIUM (ALENDRONATE) for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (A sore arm). On 29-Mar-2021, the patient experienced PRURITUS (Very itchy) and RASH (A rash on her entire body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (A sore arm), PRURITUS (Very itchy) and RASH (A rash on her entire body) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.
irritable, fevers, non-stop crying. No bowel movements unless given laxative. After receiving his shots this all began. Called doctors, twice they said shots given could not cause this and this was normal, but I went online and my son had symptoms of site affects from Rotavirus vaccine.
6-11-08 woke up and was dizzy, weak, had breathing problems and "passed out". Told by mother to go to bed - woke up with severe headache and was confused. Fell "numerous" times. Mtr. took her to Emergency Dept. - given IV to aid severe headache. Follow-up - blood work, EEG and "lung tests".
Vaccine hot; The spot where she received the vaccine is still red; Vaccine swollen; Vaccine itchy; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE ERYTHEMA (The spot where she received the vaccine is still red), VACCINATION SITE WARMTH (Vaccine hot), VACCINATION SITE SWELLING (Vaccine swollen) and VACCINATION SITE PRURITUS (Vaccine itchy) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (The spot where she received the vaccine is still red), VACCINATION SITE WARMTH (Vaccine hot), VACCINATION SITE SWELLING (Vaccine swollen) and VACCINATION SITE PRURITUS (Vaccine itchy). At the time of the report, VACCINATION SITE ERYTHEMA (The spot where she received the vaccine is still red), VACCINATION SITE WARMTH (Vaccine hot), VACCINATION SITE SWELLING (Vaccine swollen) and VACCINATION SITE PRURITUS (Vaccine itchy) outcome was unknown. Not Provided      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.   Concomitant medications were not reported.  No treatment information provided by the reporter.  Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-up information received on 02-JUL-2021 contains no new information.
Vaccine was given at 11:30 am on 7/27. That evening he developed chills, fever and dizziness. Also headache tachycardia on 7/29/12.
Day after the vaccine, I noticed a large mass under the left under arm and a smaller mass under the right underarm, a mass in the left breast.
Patient came into clinic today to receive first dose of COVID-19 Vaccine PFIZER. Pt denied any allergies to food or medications. Pt denied any reactions to previous vaccines. Pt denied anaphylaxis hx. Pt states no Vaccines in the last two weeks. Pt denies any COVID positive. Pt stated last fainting episode was two years ago with a blood draw and included lightheadedness, dizziness with Needle puncture. Pt stated these sx occur most with blood draws. Due to this pt was informed that wait time will be 30 minutes and we moved pt from room two to room eight to sit in adjustable chair. Pt father and pt son were present. Reaction: At 1343 pt. began to feel light headed and pt was given a bottle of water to sip which pt did. Pt began to close eyes and laid head back without responding after a few sips of water. Administered Sternal rub and pt was asked LOC question with no response just groaning. VS were taken. After VS were complete pt began to answer questions verbally (ie name of son, as well as how many children pt. has etc) and pt answered correctly, but pt. continued to have eyes closed, was pale, and diaphoretic. Dr. was informed and was made aware of Initial Set of vital signs which were within normal limits. Dr. requested that pt be laid flat. Pt was put in Supine position and was assessed by physician. Pt was responsive, but required further monitoring. Pt stayed for 30 min and Dr. requested orthostatic VS which were all within normal limits. Pt was released after Dr's final assessment. Patient stayed for 40 min total and Patient was awake an oriented x4, left with father and patient son with no further issues. Patient was advised for second COVID-19 Vaccine to notify nurse about incident so that proper measures can be taken for patient safety.
Became limp, weak, lethargic and irritable--crying and whimpering.  Developed fever around 9:00 p.m. He has continued to have intermittent fever for 4 days so far, and is vomiting today (6/21/2011).
Within 15 minutes of the shot patient experienced light-headedness and chest pressure.  Was able to go home after 30 minutes of observation.  later in the evening the patient experienced swelling of the face on the opposite side from the injection as well as pressure in her left ear and what felt like a golf ball in her throat.  Patient took Tylenol and the symptoms resolved over the next few days.
On 12/31/2022 I felt as if I had a cold with congestion and runny noise. I was diagnosed with Covid after reaching out to the doctor. I was not prescribed medication. Symptoms lasted about 1 week.
pt presented to clinic 19APR97 @ 12:25PM c/o puncture would to rt foot examined by MD tetanus vax given;pt states arm sore;rt arm examined 21APR97 6PM 2cm x 3cm red raised area @ inj site;
This spontaneous report was received from a licensed vocational nurse (LVN) refers to unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patients were vaccinated with a dose of GARDASIL (lot No: K011562 expiration date 08-APR-2017)(dose and route were not provided). The licensed vocational nurse (LVN) stated that on multiple unspecified date, multiple unspecified patients were administered improperly stored Gardasil. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
student came for vax appeared to be feeling well; about 5 mins p/vax mom returned to clinic stated was having breathing problems & stomach hurt & felt a bit nauseated; pt was sent to ER;
Information has been received from a medical assistant concerning her 13 yr old son who was vaccinated with a dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). On approx 09Mar05, the pt developed mumps and at the time of the report is currently in isolation in the hospital. Unspecified blood tests on approx 09Mar05 confirmed mumps. A product quality complaint was not involved. Mumps was considered to be an other important medical event. Additional information has been requested.
10/01/2008 - at 1:30pm symptoms started:  chest tightness, pain from left clavicle to mid-sternum and in back.  Face was red.  Took 3- ADVIL, and worked entire shift to 7pm.  Took 3 more ADVIL at 9pm.  Thurs. 10/2 had headache across back of head, no fever, mild aching, didn't "feel good"  and actually drove out in front of another car.  Fri 10/3- no symptoms
Developed hives at site 24 hrs after injection - with generalized hives next day.
injection site pain, tiredness, headache, muscle pain chills, joint pain, feeling unwell, bruising at the site of injection
approx 20-30 mins after vaccine was placed 2/2 cat bite sustained on 1/5/2022, our RN reported the pt slumped to her side while sitting in a chair. Pt's eyes remained open  pupils fixed. episode around 3-4 mins approx. pt. responsive through mumbling, then non responsive all while eye open. W/o any evidence of tremor or convulsions but drop in bp, became incontinent of urine. Pt. was sent to the ER and HR reported inital HR during reaction 40 raised to 75 then  despite a bag of fluids administered by paramedics was reported to have a HR of 40 upon arrival to ER. Atypical from past vasovagal reactions that I have witnessed possible seizure type response. Pt remains hospitalized we are pending reports.    The  RN who observed the inital portion of the reaction documented the following. She was performing minor wound care to fingertips. She had documented the following: Approx 20-30 mins later (still in room w me, RN), pt starting falling to one side. Attempted to assist pt and pt not responsive to sound or touch, HR palpated. Eyes open, pupils appeared dilated entire time.  (OMD) and (PCP) quickly arrived to assess. I called 911 to request ambulance stat. Attempts to get O2/HR unsuccessful d/t cold extremities. Pt w no response to sternal rub aside from grunt. Pt incontinent of urine. Moved to exam bed. HypoTN to 60s/40s. first detectable HR 40. POC BG 145. Pt remained in a catatonic state. Lack of response lasted ~3-5 minutes. Pt eventually came to, disoriented and did not remember event. Remained hypoTN but up to 70s/50s. EMS arrived in approx 8 mins. Started fluids and transported to ED.
pt received this injection 4 days earlier than the recommended 28 days interval for the second dose. no initial side effect reported
ONE WEEK AFTER VARICELLA #2, CHILD BROKE OUT IN MACULO PAPULAR RASH ON TRUNK, SOME ON ARMS AND A FEW ON UPPER THIGHS. 03/23/2011 RASH STILL PRESENT HOWEVER, NO REDNESS SWELLING OR RASH AT THE VACCINATION SITE CHILD RETURNED TODAY TO VACCINE CLINIC AND REFERRED TO PUBLIC CLINIC FOR MD EVALUATION
pt recieved HPV #1 on 1/25/07 since vaccine has had period for past 22 days. has not had issues with vaginal bleeding between period before vaccine.
Moderna vaccine (NDC 80777-0273-98) lot# 039D21A and GHN 00380777273983 was administered after the beyond date of 10/23/2021. Contacted Manufacturer Moderna = no need to repeat the dose
Severe continous  headache; This is a spontaneous report from a contactable consumer, (the patient reported for self)  A 49-years-old (non-pregnant) female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration, administered in left arm on 03May2021 at 14:00 (at the age of 49-years-old) as a single dose for COVID-19 immunization. Reason why batch/lot was Unknown: Not available/provided to reporter at the time of report completion (Unable to locate or read the details).  Medical history included rheumatoid arthritis from an unspecified date and unknown if ongoing. Concomitant medication and List of any other medications the patient received within 2 weeks of vaccination included: celecoxib (CELEBREX) taken for adenomatous polyposis coli; pregabalin (LYRICA); embril; duloxetine hydrochloride (CYMBALTA); hydrocodone bitartrate, paracetamol (NORCO); albumin human (MO) all taken at unknown doses from unspecified dates and for unspecified indications and unknown if ongoing. The patient had no other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19.   On 16Apr2021 14:00, the patient experienced severe continuous headache and this adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment for the adverse event which includes: pain management, steroids. The patient was hospitalized for severe continuous headache for 3 days. Since the vaccination, the patient had not been tested for COVID-19. The seriousness was considered as hospitalization, disability by reporter. Outcome of the event was reported as not resolved.   Device Date : 08Jun2021  Information about lot/batch number cannot be obtained.  Follow up attempts are possible, additional information has been requested.
Patient complained of swelling, warmth and redness from the site injection down towards her elbow.
headache approximately 4 hours after vaccine , treated with OTC ibuprofen. symptoms resolved
Patient received second dose of Moderna vaccine 21 days after initial dose, instead of the correct 28 day interval.
From ultrasound report: Acute right-sided epididymitis . Tiny complex cystic areas could represent spermatoceles or epidydimal fluid collection. Also from urine culture: Staphylococcus epidermidis.  Treated with 500mg of ciprofloxacin twice a day for 14 days and a Medrol dose pack
After 5 days of receiving vaccine I started with a lump, redness, itching and soreness. It began with a large red circle and spread quite a bit around my arm. It was very hot to the touch. Antibiotic was given Cephalexin 500 mg 3 x a day for 10 days, BENADRYL, anti itch cream, cold Pks. It's been over a month and arm still hurts.
Blurred vision, vertigo, dizziness, lightheaded lasting 10 days or more. As a result I?ve had difficulty driving and taking care of my child
Severe swelling of a large area about 5" across turning red and hard, Red area was hot with blisters. 102 fever for 3 days. Itching and redness spread over entire front of upper arm. Due to high fever for 3 days I am now very weak.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 20-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L025737, expiration date 28-JUL-2017 (dose and route of administration were not reported). The administered dose of vaccine underwent a temperature excursion of 47 degrees Fahrenheit for 144 hours. There was no data logger involved. There were no previous excursions reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a pharmacist via a company representative referring to a male patient. The patient's age was reported as "under 18 years old". Information about concurrent condition, concomitant medication and medical history were not provided. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 for HPV prevention (route and lot # were not provided). On an unknown date, the patient "passed out". The outcome of the event was recovered on an unspecified date. The causality assessment was not reported. No product quality compliance was involved.
10-12 days after the first shot, noticed a rash in the vaccination site; 1/14 and 3/4 inch red circles/The whole area is red.; Sluggish and tired the day after injection; Soreness in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Sluggish and tired the day after injection), VACCINATION SITE PAIN (Soreness in the left arm), VACCINATION SITE ERYTHEMA (1/14 and 3/4 inch red circles/The whole area is red.) and VACCINATION SITE RASH (10-12 days after the first shot, noticed a rash in the vaccination site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness in the left arm). On 17-Jan-2021, the patient experienced SLUGGISHNESS (Sluggish and tired the day after injection). On 28-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (1/14 and 3/4 inch red circles/The whole area is red.). On an unknown date, the patient experienced VACCINATION SITE RASH (10-12 days after the first shot, noticed a rash in the vaccination site). At the time of the report, SLUGGISHNESS (Sluggish and tired the day after injection), VACCINATION SITE PAIN (Soreness in the left arm) and VACCINATION SITE ERYTHEMA (1/14 and 3/4 inch red circles/The whole area is red.) outcome was unknown and VACCINATION SITE RASH (10-12 days after the first shot, noticed a rash in the vaccination site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided. List of concomitant medication were not given.   This case was linked to MOD-2021-187608.   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Added new event; updated narrative. On 12-Jul-2021: Non-significant Follow up appended