chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was given a first pentacel for the visit and nurse noticed as doing paperwork that the vial had not been reconstituted as powder was still in one of the two vials so only the DTaP-IPV diluent was given. Then to correct the mistake nurse gave another dose of full pentacel DTaP-IPV-HIB to revaccinate the patient when nurse should have just corrected the initial mistake by giving a single dose of HIB. Therefore patient received and extra dose of DTaP-IPV.
Pain when urinated; Blood in urine; Urinary bladder infection; This spontaneous case was reported by a consumer and describes the occurrence of DYSURIA (Pain when urinated), BLOOD URINE PRESENT (Blood in urine) and URINARY TRACT INFECTION (Urinary bladder infection) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSURIA (Pain when urinated), BLOOD URINE PRESENT (Blood in urine) and URINARY TRACT INFECTION (Urinary bladder infection). At the time of the report, DYSURIA (Pain when urinated), BLOOD URINE PRESENT (Blood in urine) and URINARY TRACT INFECTION (Urinary bladder infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood urine present: positive (Positive) Positive.         Patient had 2 fundamental shots back in February. No concomitant medication details was reported. Treatment medications taken Twice a day, 11 hours apart with name unspecified.
Got fever still do can't move right arm. Pain since got vaccine when I first got it I had dizzy spells. Lady at pharmacy made me wait 30 mins before I left. Doctor said I was inflammation in arm can't use arm arm to hot all the times good.
Suddenly my vision got super bright and I could hardly see, and then I couldn?t hold myself up and I slowly collapsed onto the ground. It only lasted a few minutes, and then I was perfectly fine. It came on very suddenly and didn?t last long, but it was extreme during those few minutes. It was also very hot that day. And I had a mild migraine headache in the morning, but that wasn?t very bad, and I get migraines fairly regularly.
Physical findings: Rash, Hives, Symptoms:  shortness of air, throat swelling, felt faint. . BP, o2 sat fine., Pt did fine and was treated immediately with epi pen, benadryl, solumedrol and fluids.
Rashes on left collar area and upper back, itchy, red. It has been a week now, not getting better.  I have had previous reactions to flu shot, so I thought it was my egg allergy so I got the flublok but still have the reaction.  Anti itch cream used to relieve itch. Typically I get a steroid pack, but I cannot now since I?m nursing.
Pt got lightheaded, after 5minutes felt better thereafter, in about 10minutes threw up. Pt stated ate 30minutes prior to vaccine. Pt stated  symptoms getting worse. Called 911. Check BP & heartrate at 17:59 on 5/26/2021 BP 140/92. Pharmacy BP recordings  3:39 125/96 5:49 139/81
used Vaxelis to vaccinate a patient at two months of age, Physician used Pentacel to vaccinate the same patient at 4 months of age with no reported adverse event; Initial information received on 30-Dec-2022 regarding an unsolicited valid  non-serious case received via call center from a physician.  This case involves a 2 months old and unknown gender patient who experienced used vaxelis to vaccinate a patient at two months of age, physician used pentacel to vaccinate the same patient at 4 months of age with no reported adverse event while receiving vaccines DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and VAXELIS.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect VAXELIS not produced by Sanofi Pasteur (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient used vaxelis to vaccinate a patient at two months of age, physician used pentacel to vaccinate the same patient at 4 months of age with no reported adverse event (wrong product administered) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE and VAXELIS.  Action taken with PENTACEL and VAXELIS was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Mother noted red blotchy rash 48 hours after shot received , rash itched mother unsure of what to do. Child received a shot of Solumedrol and Benadryl.
Temperature Excursion. Vaccine was stored refrigerated (2-8 degrees Celcius) for greater than 10 weeks. Vaccine was stored for a total of 7 days past its beyond use date 10/13/22 in the refrigerator. Patient did not experience any adverse events.
Initially, fever, chills, abdominal pain. After several medical visits, advised to go to ER, where I was diagnosed with acute appendicitis. I was given antibiotics and an appendectomy.
Information has been received from a consumer, for GARDASIL, a Pregnancy Registry product, concerning her 16 year old daughter with no known drug reactions/allergies and a history of bladder infection who on 17-AUG-2011 and 20-JAN-2012 was vaccinated with her two doses of GARDASIL (lot # not reported) respectively. There was no concomitant medication. The patient had a yeast infection and pain in her ovaries. Her acne on her face cleared up and her appetite increased. On 23-APR-2012 a pregnancy test was performed. In January 2012, Pap smear was performed. The patient was found pregnant. The patient had called the nurse. The patient's LMP (last menstrual period) was 14-OCt-2011 and EDD (estimated date of delivery) was 20-JUL-2012. At the time of the report, outcome of the patient was unknown. Follow up information has been received from the nurse practitioner's receptionist who stated that on 23-APR-2012, the patient was given a pregnancy test. The patient was not seen back in the office until 20-JUN-2013 due to vaginal spotting and vaginal discharge. There was no information available about the outcome of the pregnancy in the patient's chart. The patient's vaginal spotting and vaginal discharge outcome was unknown. Additional information has been requested.
Pt felt unwell for one week after vax. She developed painful muscles in left upper arm; which has not resolved for six weeks.
severe pain from her waist down to her thigh; felt dizzy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe pain from her waist down to her thigh) and DIZZINESS (felt dizzy) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088D21A, 023M20A and 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, received third 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 (severe pain from her waist down to her thigh) and DIZZINESS (felt dizzy). At the time of the report, PAIN IN EXTREMITY (severe pain from her waist down to her thigh) and DIZZINESS (felt dizzy) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.  It was reported that patient was not aware if she was eligible for booster dose or not.   This case was linked to MOD-2021-338524 (Patient Link).
A few minutes after injection, pt felt dizzy. Vital signs taken every 5 minutes until stable over 15 minutes. Waited additional 15 minutes sitting in waiting area.
p/vax pt devel an outbreak of chickenpox w/8 lesions on the chest & under the arm;medical attention was sought; Follow up information received. On July 20, 1998, the patient's mother called the physician's office to notify them that her child was sent home from daycare due to fluid filled lesions. The patient was seen in the physician's office on July 23, 1998. She was afebrile with no change in appetite. She was sleeping okay. The rash was described as papular on arms, face and chest. Was diagnosed with a viral rash and the plan was observation.  On an unspecified date, the patient recovered. Follow up information was received from a health care professional who reported that the patient's mother called the physician's office to report that her child had 4-5 red bumps on her back which were confirmed by the daycare as chickenpox. It was also noted that the patient had a low grade fever the week prior. The onset of the experience was reported as Jan 14, 2002. it was not indicated whether the patient was seen by a physician. The outcome of the second outbreak of varicella was not reported.
Day after receiving COVID Booster and Flu Shot patient c/o chills, fever, diarrhea, nausea, vomiting, arthralgias, headaches.
shingles; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (shingles) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Shingles. Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF), AMLODIPINE BESILATE (NORVASC), BENAZEPRIL, FINASTERIDE and SIMVASTATIN (ZOCOR) for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles) outcome was unknown. Not Provided      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.   Treatment details included valacyclovir tablets 500mg three times a day for 7 days, acyclovir ointment 5% three times a day.   Reporter did not allow further contact
Day of injection, red rash, itch, hot. Lasted 48 hours. Soreness for three-four days. Nine days after injection, red rash, hot and itchy.  I Googled symptoms; an article stated no danger, normal late reaction. Took Tylenol.  Don?t know how long it will last. This is the first day.
Diarrhea 2 days after vaccine was given, then worsening by emesis admitted for dehydration.
sore arm; She is a little dizzy; Feels weak and like having a typicla flu; Feels weak and like having a typicla flu; chills; fever of 100ºF; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), DIZZINESS (She is a little dizzy), INFLUENZA LIKE ILLNESS (Feels weak and like having a typicla flu), ASTHENIA (Feels weak and like having a typicla flu) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm), DIZZINESS (She is a little dizzy), INFLUENZA LIKE ILLNESS (Feels weak and like having a typicla flu), ASTHENIA (Feels weak and like having a typicla flu), CHILLS (chills) and PYREXIA (fever of 100ºF). At the time of the report, PAIN IN EXTREMITY (sore arm), DIZZINESS (She is a little dizzy), INFLUENZA LIKE ILLNESS (Feels weak and like having a typicla flu), ASTHENIA (Feels weak and like having a typicla flu), CHILLS (chills) and PYREXIA (fever of 100ºF) outcome was unknown. Not Provided      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 medication information provided. No treatment information provided.
After the immunization was administered to the patient, she was asked to have a seat in the waiting area for observation.  A few minutes after she sat, she told her husband who was seated with her she didn't feel well (he did not inform us).  The technician observing her noticed she passed out and reported to the pharmacist (myself).  I designated a team member to call 911 and ran out to the patient.  She was extremely pale and her lips were blue.  With the assistance of her husband I laid her on the floor, had him elevate her feet and checked for pulse and breathing.  I couldn't immediately find her pulse but within 30 seconds she began to come to.  She appeared to tremor a few times as she came to and her color began to return.  She was extremely confused and did not know where she was upon awakening.  EMS arrived on the scene approximately 10-15 minutes after the event.  They did standard patient evaluation which was unremarkable and proceeded to bring her to the local ED,  According to the patient, the ED visit yielded nothing and they said "she couldn't be more healthy".  One note, that was revealed in conversation with the patient while waiting for EMS to arrive is that the patient had very little to eat or drink prior to being administered the vaccine.
Patient complained of pain at the injection site and redness. When patient came in the area of redness started just below elbow and continued to her wrist. It was slightly warm to the touch. Patient also had a large bruise below injection site and above elbow.
Fever 102.8 Saturday AM , weak, tired, body aches, sore arm
febrile seizures; ran fever 102 might of immun; had noted MD to get immunized w/MMR due to poss egg allergy; had hives 1x p/eating eggs but MD ok'd MMR;
Patient filled out VARS, she checked she had no allergies, during technician screening she was asked if she had allergies and she said no, during pharmacist screening she was asked again and she responded that she did not.  The vaccine was given and she was being monitored when she said she was having trouble breathing.  The shortness of breath continued and she was administered the epipen and given oxygen, SOB continued and another epipen was administered.  The paramedics arrived and patient was taken to nearby hospital
Swelling, redness of upper arm. Resolved with ice, Motrin. (Reporting office received similar complaints following recent DTaP)
contracted COVID after being vaccinated; contracted COVID after being vaccinated; This is a spontaneous report from a contactable other healthcare professional (patient) (as reported). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient contracted COVID after being vaccinated on an unspecified date. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective / COVID-19 cannot be ruled out.
Pt .c/o feeling light headed and was verbal, A$Ox 4. She was taken in a wheelchair to a cubicle where she was asked to lay down  in a cot. 2 small packets of crackers , 3 pkts of apple juice and water were offered. Total fluid intake - 500 mls. Pt. verbalized absence of dizziness and said she was well to leave. At 3:15 p m she walked away in the company of her mom unassisted.
Damage to shoulder after boostrix; Fluid in shoulder, debris in this fluid; Limited Range of Motion in left shoulder/cannot move arm; Great Pain, pain with certain motions; she cannot sleep on her left side due to the pain; This case was reported by a consumer via call center representative and described the occurrence of shoulder injury in a 66-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 224CG, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd June 2022, the patient received Boostrix (intramuscular) .5 ml and Boostrix Pre-Filled Syringe Device. On 2nd June 2022, less than a day after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced shoulder injury, bone shedding debris, injected limb mobility decreased, shoulder pain and difficulty sleeping. The patient was treated with ambiguous medication nos (Cortisone (Nos)), ibuprofen, diphenhydramine hydrochloride + ibuprofen (Ibuprofen Pm) and opioids {nos} (Opioids). On an unknown date, the outcome of the shoulder injury, bone shedding debris, injected limb mobility decreased, shoulder pain and difficulty sleeping were not recovered/not resolved.   It was unknown if the reporter considered the shoulder injury, bone shedding debris, injected limb mobility decreased, shoulder pain and difficulty sleeping to be related to Boostrix and Boostrix Pre-Filled Syringe Device.   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: 08-Aug-2022 Reporter's Comments: The patient self reported this case for herself.  The patient received Boostrix on 2nd June 2022. Later that day, she began to experience great pain and limited range of motion in her left shoulder. She can not pull up her pants, she can not reach out her arm and move it above it being straight out , she cannot sleep on her left side due to the pain. 3 weeks after receiving the vaccine, she was sent to have an MRI which showed damage to her shoulder, fluid in the shoulder and that there was debris in this fluid. Subsequently she was seen by an orthopedic doctor who gave her a cortisone shot in the shoulder on19th July 2022. At the time of the call, the pain in her shoulder still exists, but it was better than it was before and she had pain with certain motions and still can not sleep on her left side. She had been seen by physical therapy, in which she does daily exercises which helps with her range of motion. She had been taking Ibuprofen for the pain and Ibuprofen PM to help her sleep. She had been prescribed opioids prior to the ibuprofen but she was unable to tolerate them. The reporter consented to follow up. Additional supportive information: As the patient was taking medicine for sleep, difficulty in sleeping was captured as an event.
Swollen tender lymphnodes l. Supraclavicular, L. Axillary, L. Cervical 1 day after 2nd vaccine.    Headache, chills, sore thrat, nasal congestion started mostly day after, headache day of both tbe first and second vaccine
That afternoon, she was lethargic, achy and her arm was sore, so I gave her Tylenol. She had trouble sleeping that night. On Sunday morning, I gave her two Ibuprofen around 9 because her arm was still hurting. Around 9:30, she came in saying she was having chest pains and her pulse rate was over 120. I took her to the ER. Her heart rate was 128 when they triaged her. They gave her an IV and a saline drip, an EKG and chest x-ray, all of which were fine. Due to her being on birth control, they also did a d-dimer test, which was elevated at 442. They then did a lung scan to rule out a pulmonary embolism. Those results were negative as well. The chest pains resolved around 11 am. Since they ruled out the blood clot and nothing was found to be wrong with her heart, she was sent home. They figured that she maybe had an anxiety attack or heart palpations. I took her to her pediatrician the next day and she was cleared there as well.
Patient received Shingrix on 10/5/21 that expired on 10/1/21. I have not heard from the patient regarding any adverse reactions.
Suspected vaccination failure; I've had 2 vax last June/September, now having mild shingles/; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In September 2021, the patient received the 2nd dose of Shingrix. In June 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and less than a year after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 16-MAY-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient had 2 Shingrix vaccine in last June/September, now having mild shingles. The reporter wanted to know that if he/she was contagious to children or other post vaccines. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Lot FL0007 09/2021 diluted on 1/24/22 at 0954, labeled to expire on 1/24/22 at 2154 stored in vaccine fridge overnight after clinic closed and into today.  A vaccine was administered today at approximately 1205.
2-13-17 fever, febrile seizure, rash occurring 9 days after vaccine administered. RVP (respiratory viral serial negative) Rash localized around MMR site administration and extend to torso.
Very significant swelling and inflammation at the injection site (shoulder).  So concerning the next day, that we took him back to the doctor so they could look at.  The swelling took many days before it went away.
Patient states that when she woke up on Friday morning around 5:30 am she had developed a single welt on her neck and face  and a rash  around the welt.  She also had chills that started April 3rd. Tuesday April 6th, she developed a feeling like she was floating and, she felt off - like in a mind fog and sensation lasted for about 20 minutes and it has not returned since.