chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 11-Jul-2018 regarding an unsolicited valid non-serious case received from a Non health care professional. This case involves female patient (age unknown) (medical office assistant) who experienced flange on the syringe broke while the vaccine was being given, when the flange broke it cut her unknown finger, while she received vaccine ADACEL. The patients past medical history, concomitant medication and family history were not provided. On 06-Jul-2018, the patient received a 0.5ml dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine, lot U5875AA, expiry date not provided via unknown route in unknown administration site. On 06-Jul-2018, the flange on the syringe broke while the vaccine was being given, when the flange broke it cut the patients unknown finger (laceration) and (syringe issue) same day following the administration of Diphtheria -2/Tetanus/5 AC Pertussis Vaccine. Final diagnosis was flange on the syringe broke while the vaccine was being given, when the flange broke it cut the medical office assistants unknown finger. Lab data was not provided. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown. List of documents held by sender- none.
arm swollen to approx 4xs its size, hot and hard to the touch, swelling from mid back to wrist and into face
Mother noticed while being in the air conditioner patients face red. No swelling. No further rash. No difficulty breathing or wheezing. Patient feet were red/hot to the touch. Infection sites warm.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose02/01/21 2nd dose02/22/21 Diagnosed covid positive:08/26/21 Symptom onset:08/25/21 Exposure: Symptoms:FEVER, COUGH FATIGHUE, SORETHROAT.
Had shots, got shingles/Suspected vaccination Failure; Got shingles on shoulder, arm, breast; pain, couldn't take the pain, suffered; Cried; Moaned; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a elderly patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In DEC-2022, less than a year after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shots, got shingles/Suspected vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: Got shingles on shoulder, arm, breast), crying (Verbatim: Cried), moaning (Verbatim: Moaned) and pain (Verbatim: pain, couldn't take the pain, suffered).The patient was treated with tramadol, fentanyl and hydromorphone hydrochloride (Dilaudid). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were recovered/resolved and the outcome of the crying and moaning were recovered/resolved (duration 3 weeks).   It was unknown if the reporter considered the vaccination failure, shingles, crying, moaning and pain to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles, crying, moaning and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-MAR-2023 This case was reported by a patient via interactive digital media. The patient was 76 years old at the time of reporting and lived in assisted living. The patient had the shingle shots in 2022 but in December of 2022, he/she got the shingles on his/her left shoulder blade under arm and left breast. The patient cried and moaned for 3 weeks and then went to a place they called a hospital but far from it and they offered him/her 2 Tramadol. Unfortunately he/she had to have Fentanyl for pain so they sent him/her home without even looking at shingles but he/she still could not take the pain so the next day he/she went back to that same hell hole and this time they took chest x-ray and offered him/her Dillaudin another joke so he/she suffered for over a month and half. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Initial vaccine was Johnson&Johnson. 2 boosters were Pfizer; Paxlovid for COVID 19 Treatment; Paxlovid for COVID 19 Treatment; This is a spontaneous report received from contactable reporter (consumer). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 OMI BA.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 2 (booster), single (Lot number: Unknown) and as dose 3 (booster), single (Lot number: Unknown) for COVID-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing). Concomitant medication included: PROZAC. Past drug history included: Known allergies: Keflax, reaction: "Known allergies: Keflax". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Initial vaccine was Johnson&Johnson. 2 boosters were Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Feb2023, outcome "not recovered" and all described as "Paxlovid for COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, COVID-19. Clinical course: The patient experienced sore throat, sneezing, and stuffy nose on 20Feb2023 and was treated with Paxlovid for COVID-19 from 02Mar2023 to 07Mar2023.   The information on the batch/lot number for BNT162b2, BNT162b2 OMI BA.4-5 has been requested and will be submitted if and when received.
I received the vaccine on April 12. I was to have my next period on April 19. Instead it came early on April 13. I had a lot of cramping and breast pain the first 48 hours after the vaccine injection which is not normal for me. My period also lasted 15 days. It normally lasts 2 - 3 days.
COVID-19 Vaccine EUA On approximately the 6th day after injection, I noticed a light red area about 2" in diameter in the area of the injection site.  The area is firm and slightly warm. Pharmacy advised taking benadryl if needed.  Have not done so at this time.  Symptoms seem stable or improving at this time.
2D SP vaccine placement pt developed 4-6 cm sterile abcsess on left thigh.
Information has been received from a nurse referring to unspecified patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not provided. On unknown dates the unspecified patients received doses of improperly stored PROQUAD (rHA) (strength, dose, frequency, route were not reported, lot # N031929, expiry date 12-MAY-2019) for prophylaxis. Concomitant therapy included sterile diluent (lot # and expiry date were unknown). Sterile diluent used to reconstitute PROQUAD was stored properly. The temperature and time frame were unknown. There were no previous excursions reported. The call was because of a data logger. No adverse effects were reported. Follow up information was received on 05-SEP-2018 from the nurse and later form the physician. The reporters stated that three female children and five male children between the ages of 1 year and 4 years received doses of PROQUAD on an unspecified date in the past 3 months in approximately 2018. The patient was 1 year old White female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided. There had been no adverse events following the administration of the improperly stored PROQUAD vaccinations. This was just temperature issue where temperature reached -12 Celsius degree.; Sender's Comments: US-009507513-1808USA010810: US-009507513-1809USA004055: US-009507513-1809USA004056: US-009507513-1809USA004057: US-009507513-1809USA004058: US-009507513-1809USA004060: US-009507513-1809USA004061:
Pt describes temp 102.2 F orally several hours after injection. Also complained of nausea and vomiting but was also taking Flagyl  for Vaginitis.
19JUN98 pt had a stiff neck;20JUN98 2 had pain in all joints then in all muscles w/sensitivity to light then chills & fever T102;sore all over legs;inflammation & enlargement of internal organs;rash & pruritus all over;fatigue;urine orange;
About 330 pm child vomited x 4. Around 530 child lost consciousness, went completely limp, lasted for 1 min or less. No seizure activity. In ER at 610 pm. ER record included.
Information has been received from a Registered Nurse concerning multiple unspecified patients of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot number M022077 with an expiration date of 19-MAR-2019) (strength, dosage schedule, route and anatomical location were not reported). Other suspect and concomitant medications were not provided. There was no adverse effect reported. The doses of the vaccine experienced a temperature excursion of 1 Celsius (C) for 48 hours. The aforementioned temperature was identified due to a data logger. There were no previous excursions reported. Furthermore, no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Provider discharge summary "Patient had been under hospice care at a local extended care facility due to history of Vascular dementia with behavior disturbance and Hemiplegia, Dysphagia as late effects of cerebral infarction developed Hypoxia.  This appears due to a COVID-19 virus infection.  He has been started on DECADRON and REMDESIVIR. He improved and was able to be weaned off supplemental oxygen.  He completed his course of DECADRON in the hospital.  The patient was medically stable for discharge on 4/29/22 but the facility where he had been residing initially refused to take the patient back and as such his hospital stay was inappropriately lengthened.      Continuing medications for dementia: QUETIAPINE GABAPENTIN DIVALPROEX ESCITALOPRAM  BUPROPION  For history of stroke on ASPIRIN, CLOPIDOGREL,.   For hyperglycemia on sliding scale but had not required much coverage. "
Received concentrated dose from a vial that was not diluted.  06/23/21 @ 9:59  I called patient to follow-up on Friday?s incident (6/18).  She said that Saturday she couldn?t move her left arm because it was so uncomfortable, also had a hard time sleeping.  Also, her appetite was greatly reduced and was nauseated.  She tried taking ibuprofen taking it only once and it did not do anything for the discomfort; nor did the methadone.  Sunday, could start using arm though it still hurt.  Today she can move her arm without hurting, there is some swelling, redness at the injection site with tenderness but improved.  Appetite is improving though not back to normal.  To call if gets worse or has concerns.
Pt's LMP 11/5/12 had to Tdap 11/15/12. Pt was early pregnant baby now has hypoplastic Lt heart.
Started experiencing fatigue, muscle weakness.  After light cardio exercise, energy depleted and would have to lie down and then would fall asleep.  I didn't feel sleepy, just extremely weak.  Most pronounced in the arms and legs, but sometimes felt like whole body.  Saw doctor on 5/12.  Later on 6/5 had a complete CBC, physical workup.  Some values were slightly out of range, but nothing significant.  Went to urgent care about a week or so later because symptoms seemed to be getting worse.  They repeated the complete CBC and also ran a lactic acid test.  Again results were insignificant.  Echo completed on 7/1 showing only mild diastolic disfunction.  I'm afraid to exercise.  I wake up in the morning with a mild tingling in hands and legs.  As the morning progresses, the tingling, weakness, fatigue get worse.   I can have some fairly good days, but most are not good.  I have experienced some fatigue in the past, but this time has absolutely been the worse.   Even as I am writing this, I feel the tingling, weakness in my hands.  Earlier my legs felt achy,  Legs feel ok at this time.
felt sick; trouble focusing; eyesight is a little off; cold chills; Patient looked at the injection site and said that it hurts and it is a little bit red but nothing major; cold chills; fatigue; headache; muscle pain; Patient looked at the injection site and said that it hurts and it is a little bit red but nothing major; heart palpitations; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitations), ILLNESS (felt sick), DISTURBANCE IN ATTENTION (trouble focusing), VISUAL IMPAIRMENT (eyesight is a little off) and FEELING COLD (cold chills) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: flu shot in November 2021 and Shingles vaccine in November 2021. Past adverse reactions to the above products included No adverse event with Shingles vaccine and flu shot. Concurrent medical conditions included Arthritis (Patient said that he always has joint pain because he has arthritis.) and Overweight. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BANOPHEN) for an unknown indication.   On 12-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 12-Nov-2021, the patient experienced PALPITATIONS (heart palpitations). On 13-Nov-2021, the patient experienced ILLNESS (felt sick), DISTURBANCE IN ATTENTION (trouble focusing), VISUAL IMPAIRMENT (eyesight is a little off), FEELING COLD (cold chills), VACCINATION SITE PAIN (Patient looked at the injection site and said that it hurts and it is a little bit red but nothing major), CHILLS (cold chills), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain) and VACCINATION SITE ERYTHEMA (Patient looked at the injection site and said that it hurts and it is a little bit red but nothing major). On 12-Nov-2021, PALPITATIONS (heart palpitations) had resolved. At the time of the report, ILLNESS (felt sick), VISUAL IMPAIRMENT (eyesight is a little off), FEELING COLD (cold chills), VACCINATION SITE PAIN (Patient looked at the injection site and said that it hurts and it is a little bit red but nothing major), CHILLS (cold chills), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain) and VACCINATION SITE ERYTHEMA (Patient looked at the injection site and said that it hurts and it is a little bit red but nothing major) had not resolved and DISTURBANCE IN ATTENTION (trouble focusing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment medications were reported  The patient stated Right now symptoms are ongoing
Information has been received on 08-OCT-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 01-FEB-2017, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a hospital emergency department as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 15-FEB-2017, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, 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. Additional information has been requested.
COVID Breakthrough vaccine case - Patient received 1st Moderna vaccine on 1/17/2021 and 2nd Moderna vaccine on 2/11/2021.  Patient tested +COVID via PCR testing on 4/21/2021.  Patient is asymptomatic.
This non-serious spontaneous case, was initially received from a physician on 14-Aug-2017, concerns a 06-year-old male child patient. Physician reported 10 patients who were vaccinated after multiple temperature excursions. This report was 7th of 10 reports. On 03-Apr-2017, the patient was administered with FLUCELVAX QIV (batch number: 186686 (reported ass 185586, 186686), expiry date: 31-May-2017, dose, route of administration and anatomical location: not reported). Multiple temperature excursions were occurred on 02-Mar-2017, vaccine was stored at 47F for 14.7h (1st excursion), on 03-Mar-2017, vaccine was stored at 47F for 16h (2nd excursion) and on 04-Mar-2017, vaccine was stored at 47F for 19.75h (3rd excursion) which was considered as incorrect product storage. The patient was administered with vaccine which was stored at 46F to 77F up to 24 hours instead of storing at 36-46F which was considered as drug administration error. Non-significant case correction received with IRD: 14-Aug-2017. Batch number (186686) was captured in the case form and narrative was amended accordingly.
Monday: sore arm after vaccination (high on left arm). Very sleepy about 10:30 pm.   Difficulty sleeping when rolled onto left arm/shoulder. Tuesday:  Arm looks fine, can't tell if any swelling, but I have headaches, shortness of breath, dizziness while driving.  No fever. Wednesday: Felt worse than Tuesday, hard to get out of bed.  More dizziness and headaches.  Hard to concentrate on work.  No fever. Thursday: Felt better than Wednesday but still wobbly.   Occasional headache.  Runny nose.  Some nausea.   Emailed my doctor to ask if I should get a covid test.  She said to wait a day or two as my symptoms were probably just a bad reaction. Friday:  feel better today but still thought I should document this when I saw there was a place to do so.
I started to have a sore throat, headache, dizziness, nasal congestion, and stomachache. On the second day of my symptoms, I went into an urgent care clinic because I found out that I was exposed to someone who was COVID positive. I was tested for COVID, and it came back positive. I was given the antibody infusion treatment. My symptoms lasted about 10 days.
Patient had a 5 cm x 6 cm reddened area to her right thigh. The redness had faded now. Patient's mother had a picture on her cell phone that showed how red it was over the weekend.
Parents report (at 4 mo visit) excessive crying after 2 mo shots. Stopping breathing and eyes rolling. Paramedics were called, baby was not transported.
At around 7pm on 11/03/2022 patient states she had a severe headache which has subsided but still present. Is now experiencing dizziness. States her equilibrium is off and feels as if she was drunk. Headache is still present but not as severe as the night prior.
relative died; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "relative died". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: The reporter mentioned her 2 relatives died when they took the vaccine and her husband became sickly when he took the vaccine too.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300061028 same reporter/vaccine/event, different patient;; Reported Cause(s) of Death: relative died
I went into pharmacy for the flu shot. I requested preservative free version.  Afluria 2014-2015 syringe. Qty .5ML  The shot was administered very high on the shoulder. I believe it was injected into the joint area or bursa instead of the muscle. The shoulder joint area has been increasing painful by the hour, and I am unable to use the left arm in a full range of motion, and unable to drive the car with the left arm. I must make very slow movements due to the pain. There is very little strength in the shoulder now. Doctors office is closed, I will make an appointment as soon as possible. I notified the pharmacy, and I am waiting to hear from the pharmacy manager. I very highly suspect this is what is known as "Sirva"  (shoulder injury as result of vaccination).
Patient given monovalent Moderna vaccine that was expired 3/11/2023 on 5/2/2023
I experienced a low-grade fever (100), muscle and joint pain, pain at the injection site, and fatigue during the first 24 hours after receiving the vaccine. A little less than 24 hours after the vaccine, my fever broke, and I began to develop a rash on my legs, which consisted of small, itchy, bug-bite like red bumps. I consulted my primary care physician, who recommended I take Benadryl. The rash worsened and spread to my torso - stomach, chest, underarms, and forearms - but was never present at the injection site. The rash on my chest was significantly different than the rest of my body, and when I saw an urgent care provider (5 days after being vaccinated), she diagnosed the chest rash as a separate issue (Folliculitis) and prescribed oral antibiotics. I saw no improvement in any symptoms. A week after being vaccinated and symptoms not improving, I saw my Allergist, who prescribed a 10-day course of oral steroids (Prednisone). My symptoms gradually improved, but the rash did not fully disappear for approximately 3 weeks after the first symptoms appeared.
Patient experienced adverse event following a flu vaccine. Pt received the vaccine on 10/27/17, reports red bumps on her chest on 10/28/17 that wasn't itchy. Today 10/30/17 pt states she developed more red bumps/rash on stomach and on arms (crease of elbow). The only itchy areas appear to be on the chest (severity:  mild itchiness). No injection site pains/rash. Pt states she does not have allergies to neomycin, eggs or latex. Has not taken any new medications or foods or used any new soaps or detergents. Pt has had a flu shot before (around 13 years ago) with no issues. States she had cold like symptoms that she attributed to the shot and has not gotten it since. Per my recommendation, she will visit her primary care provider tomorrow.
The pt developed erythema multiforme rash began on 05/06/2002 after vaccines on 05/01/2002.
The patient had vaccines in the last 36 hours and had a DTaP on his left leg.  Mother has noted progressive swelling and redness and somewhat itching around that area.  He also had a scratch over that same area.