chrisvoncsefalvay/vaers-outcomes huggingface dataset:
painful axillary swelling; painful axillary swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 Immunization. The following information was reported: PAIN (non-serious), SWELLING (non-serious), outcome "unknown" and all described as "painful axillary swelling". The event "painful axillary swelling" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Several doctor visits and many expensive tests, all to no avail.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I didn't feel great; My muscle in the area where I got the shot was aching; My body is not feeling well; My muscle in the area where I got the shot was aching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "I didn't feel great"; MYALGIA (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "My muscle in the area where I got the shot was aching"; MALAISE (non-serious), outcome "unknown", described as "My body is not feeling well". The event "i didn't feel great" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of feeling abnormal, myalgia, malaise, vaccination site pain.  Additional information: Date of vaccination: The patient stated that he received first dose on Tuesday and due date for second dose was on 23Mar2021. The patient reported that he had a first dose for Pfizer Covid-19 vaccine and after he got the shot in the morning, in the morning he was okay, but in the afternoon, he did not feel great and his muscle in the area where he got the shot was aching and his body was not feeling well. So, he took the Advil (treatment) in the evening and heard that the Advil would interfere with this creating an antibody and he should have taken Tylenol (further clarification unknown) and so, he wanted to ask about the effectiveness of vaccine after took the Advil. The patient concerned about the effectiveness after took the Advil, it was 200 mg.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
11/30/15 received vaccines. Drove out of town after vaccines and was unresponsive when arriving. Remained in ICU and pronounced dead on 12/3/15.
Sore throat followed a few days later by congestion, malaise, low grade fever, runny nose, and a few days later by vomiting. Lasted almost 2 weeks. This was a mandatory vaccine at work, many people had flu symptoms. We were not informed to report any of this to CDC. Everyone just called out sick.  Lot # 123121 from Novartis.
Fever, sweats chills, arm soreness, aches, dizzy treated with acetaminophen
Pain that radiates down arm to the fingers. Swelling of the arm, swelling in armpit and on chest. Swelling that is hard as a rock and visible by sight. Doctor prescribed prednisone for 7 days with tapering dosage. Only on 2nd day of those meds currently.
Pt slumped forward from an upright, seated position (head in lap). Pt was observed drooling. Pt then sat upright with head and upper body twitching and shaking. Pt's eyes were rolled back in her head. Pt then came out of event and stared confusedly at provider. Pt appeared to be post ictal. Entire event lasted 10-15 seconds.
wrong vaccine was administered to a patient with no reported adverse event; Initial information received on 10-May-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 52 years old female patient and is reported diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] wrong vaccine was administered to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-May-2023, the patient received a dose 0.5 ml of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine Suspension for injection strength: not reported lot number C5893AA expiry date: 21-Jun-2023 not reported via intramuscular route in the right deltoid for prophylactic vaccination (immunization).  On an unknown date the patient developed a non-serious wrong vaccine was administered to a patient with no reported adverse event (wrong product administered) on the same day following the administration of Diphtheria-15/Tetanus/5 AC Pertussis Vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event wrong vaccine was administered to a patient with no reported adverse 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 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.
The vaccination was given at 1802.  At approximately 1804 the patient stated she did not feel quite right and something may be wrong.  She stated she was feeling all warm.  She was complaining of mild heat or burning traveling from the vaccination arm, across her chest to the other arm and down her torso.  Did not complain of any breathing difficulties or other symptoms.  Her heart rate and respirations were normal.  Upper extremities were examined for redness or hives - none found.  The heat flash lasted about 2 minutes then she stated she felt normal.  She was observed for another 20 minutes.  She was examined again before leaving and no signs or symptoms were noted at that time.  She felt normal before leaving the clinic.
First day, itchy near injection site Second day itchiness goes away, but lump forms and aches Fourth day pain goes away, lump remains Seventh day lump looks and feels bigger, itches and burns
This case was reported by a pharmacist via other manufacturer and described the occurrence of allergic reaction in a unk patient who received Rabies NVS (Rabies Vaccine). On an unknown date, the patient received Rabies vaccine. On an unknown date, an unknown time after receiving Rabies vaccine, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to Rabies vaccine. Additional information was provided. The pharmacist stated that an unspecified patient had an unspecified allergic reaction to an unspecified lot/exp of Rabies vaccine on an unspecified date, ordered by an unspecified physician.
Mild headache, fatigue and myalgia beginning AM after the immunization and all resolved within 24 hours with no treatment.  Sore arm at injection site for 3 days.
This spontaneous report as received from a nurse refers to a 2 years old male patient with no known allergies. The patient was vaccinated with VARIVAX (lot # (666872/0473Z), expiration date: 31-MAR-2012, dose unknown) on 12-OCT-2011. No other co-suspects were reported. No concomitant medications were reported. On 29-AUG-2012 the patient developed chicken pox. The nurse reported that the patient had about 40 pustules on the trunk and legs that were itchy, without fever. Treatment of over the counter AVEENO was given for the adverse event. The outcome of chicken pox was reported as not recovered/not resolved. The relatedness for chicken pox is unknown for VARIVAX. No lab diagnosis studies performed. The patient sought medical attention via office visiting. Additional information is not expected.
Presented to ED 10/9/17 for fever and rash. Had a simple febrile seizure in the ED. Admitted to the hospital for observation. Treatment was supportive (Tylenol, fluids). Event report submitted upon admission to the hospital (anticipate discharge tomorrow, but TBD depending how the night goes).
HCP called to get information on GARDASIL 9 alternative dosing schedules. HCP stated GARDASIL 9 was given to a patient   at age 11 (1st dose administered on 8/13/2019), at age 15 (2nd dose, 8/08/2023), at age15 (3rd dose on 9/21/2023). No other infor; No additional AE reported. No PQC reported; This spontaneous report was received from Other Health Professional and refers to a paient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 08-AUG-2023, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 2nd dose, lot #W026151, expiration date: 20-OCT-2024 (strength, route of administration, and indication were not provided). On 13-AUG-2019, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1s dose, lot #R029512, expiration date: 08-JUL-2021, administered for prophylaxis (strength, and route of administration were not provided). On 21-SEP-2023, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 3rd dose, lot #X005044, expiration date: 02-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided).  On an unknown date, the patient experienced HCP called to get information on GARDASIL 9 alternative dosing schedules. HCP stated GARDASIL 9 was given to a patient at age 11 (1st dose), at age 15 (2nd dose), at age 15 (3rd dose). No other information. No additional AE reported. No PQC reported.
Approx 15mins post vax pt dev wheezing & c/o chest tightness, coughing. hx asthma no asthma attack past 5 yrs. Given Adrenalin @ 2PM VS monitored & stayed stable @ BP 150/78; PR elevated w/some shaking p/Adrenalin-c/o vision blurring.
PT STARTED DEVELOPING " DIFFICULTY IN BREATHING" AND DIZZINESS ABOUT 15 MINUTES AFTER HE RECEIVED THE VACCINE. 8:55 HR 61 RESP 16 BP 115/76 OXYGEN SATS 99% ROOM AIR PATIENT WAS BROUGHT TO MED OBS 1 AT 855, HE WAS GIVEN APPLE JUICE AND WATER.  ODI WAS WITH PATIENT SINCE HE WAS foreign SPEAKING ONLY 0900 HR 60 RESP 15 BP 108/74 OXYGEN SATS 99% ROOM AIR 0905 HR 60 RESP 15 BP 118/77 OXYGEN SAT 100% ROOM AIR PT WAS FEELING BETTER AND LEFT BY HIMSELF ESCORTED TO EXIT BY STAFF
TESTED   +   FOR COVID ON 12-29-2021  DECEASED ON  3-18-22.  I HAVE NO FURTHER INFORMATION OTHER THAN SHE WAS STILL COVID + ON 1-19-2022
First 48 hours -insertion site myalgia.  4-5 days later-dizziness, fatigue.
Nausea, Chills, Fatigue, muscle/body aches, runny nose Lasted 24 hours
Patient developed a 2.5 cm wheal immediately adjacent to subcutaneous injection site of MMR on right anterolateral thigh.
Document Type: MRA Brain W/O IV Contrast Document Subject: MRA Brain W/O IV Contrast Performed on March 17, 2022 13:36 EDT Verified on March 17, 2022 16:25 EDT  Hospital, Outpatient, 03/17/22 - 03/17/22  * Final Report *  Reason For Exam acute left eye blindness  Report EXAMINATION:  MRA Brain W/O IV Contrast  EXAM DATE:  03/17/2022 13:36  CLINICAL INFORMATION:  Acute left eye blindness, CVA 2 weeks ago. No trauma, no brain surgery, no trauma.   COMPARISON:  None available.  TECHNIQUE:  3-D time-of-flight MRA of the brain was performed. Source images and maximum intensity projection images were reconstructed and reviewed with respect to criteria.  Normal flow is seen in both internal carotid arteries. The M1 and A1 segments are patent. The anterior communicating artery is patent. The orbital vessels are not visualized at this resolution. The posterior communicating arteries are not seen. The right vertebral artery is mildly dominant. The basilar artery has normal branching. There is no evidence of intracranial hemorrhage and diffusion-weighted imaging shows no evidence of recent infarct. There is no evidence of aneurysm, dissection or flow limiting stenosis.  IMPRESSION:  Normal MRA of the brain.          Electronically Signed Dictated on: 3/17/2022 4:20 PM    Signature Line This examination and reported findings have been reviewed and confirmed by the undersigned.     I authorize my name to be Electronically affixed by using my unique signature access code.   Click VIEW IMAGE icon to Display Image This document has an image
pt recv vax 24JUL98 & 28JUL98 rash in area of arm where shot given;hives;30JUL98 chills, fever suspected;31JUL98 swelling of lips, eyes & ankles;1AUG98 T102, hives;2AUG98 T104 & more spots on face;
On the day of the shots patient stated it was sore and hurt with some burning. Improved with rubbing the area. The next day it stopped hurting but it itched. On the 14th the area was slightly swollen with a red rash all around the area where the shot was given. Ice pack given and improved now.
In August 2022 I went to my ENT because I had a cold. He decided to do a scope and he saw a spot that he didn't like. I went back when I was well, and he did a biopsy of the spot and a CT scan. It showed I had something in the lymph node in my nasal cavity. It was a return of the cancer I had before but not in the same place. I had been cancer free for 8 years. The type of epiphyseal marrow blastoma that originates in olfactory nerve. This time it was found in the upper part of my throat but same type of cells as previous cancer. I had surgery to remove the cancer.
Got a rash on most of body; The patient received the third/booster dose of BNT162b2; The patient received influenza vaccine (flu shot) and BNT162b2 on the same day (23Oct2021); The patient received influenza vaccine (flu shot) and BNT162b2 on the same day (23Oct2021); This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Oct2021 12:15 (Lot number: EW0217) at the age of 31 years as dose 3 (booster), single for covid-19 immunization; influenza vaccine (INFLUENZA), administered in arm right, administration date 23Oct2021 (Batch/Lot number: unknown) for immunization. Relevant medical history included: "Shellfish allergy" (unspecified if ongoing), notes: Known allergies: Scallops. The patient took concomitant medications. Past drug history included: Zyrtec, reaction(s): "Drug allergy", notes: Known allergies: Zyrtec; Levaquin, reaction(s): "Drug allergy", notes: Known allergies: Levaquin. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EN6200; Administration time: 15:30; Anatomical site: Left arm), administration date: 16Feb2021, when the patient was 31 years old, for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE; Lot Number: EN6199; Administration time: 12:30; Anatomical site: Left arm), administration date: 09Mar2021, when the patient was 31 years old, for COVID-19 immunization.  The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 23Oct2021, outcome "unknown" and all described as "The patient received influenza vaccine (flu shot) and BNT162b2 on the same day (23Oct2021)"; IMMUNIZATION (non-serious) with onset 23Oct2021 12:15, outcome "unknown", described as "The patient received the third/booster dose of BNT162b2"; RASH (non-serious) with onset 24Oct2021, outcome "recovered" (2021), described as "Got a rash on most of body". The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the event which included treatment with diphenhydramine (BENADRYL) and it stopped the spread. Since the vaccination, the patient had not been tested for COVID-19.  Follow-up (24Nov2021): Follow-up attempts are completed. No further information is expected.
My arm started here hurting terribly within a couple minutes of the shot. By the time I went to bed a few hours later my arm hurts so bad I couldn?t touch it to anything. By the time I woke up I was achy all over and have had a fever of up to 101.1 all day. My stomach is also very upset and I?m nauseous. Not able to eat much at all, only had some chicken broth.
Rapid heart rate & shortness of breath x 1 hour, pain at injection site and entire upper extremity x 2 days, nausea and vomiting approx. 2 hours after injection.
got the shot then got shingles/suspected vaccination failure; got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had Shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles and laboratory confirmation for herpes zoster were not provided. This case linked with US2021AMR127128, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR127128:Same reporter
developed hives while sleeping, woke up and took a Benadryl. Hives came back twice as bad later in the day. Hives were on every extremity of my body. Multiple Benadryl doses have subdued the hives.
Began having body/muscle aches after having received flu vaaccine on 10/13/2015. Also began having oral ulcerations. Fever of 101.6 on 10/18/2015, body aches worsening. Began having vulvar ulcerations on 10/20/2015. To ER. Sent home same day with pain meds/supportive care. Pain worse on 10/22/15 with fever up to 103. Also c/o of right eye pain on 10/22/15. Admitted to hospital at this time. Given steroids, Flagyl, pain meds and vaginal suppository. Discharged 10/24/15. Discharge diagnosis: Stevens Johnson Syndrome vs. Viral Syndrome.
First evening after shot felt feverish, with headache, and painful eye orbits.  Mild discomfort at injection site. Took a Tylenol and went to bed at 11:00 PM.  That night and next day headache gone, but achy fevery malaise continued plus now I was having abdominal cramps, bloating, and gas pains.  This turned into stool changes bordering on diarrhea.  As 10/17/09 turned over to 10/18/09 the cramps turned into real diarrhea.  I could barely sleep having constant level 3 or 4 of 10 pain all night in the lower abdomen, and frequent bathroom trips for the diarrhea.  It is now the morning of 10/18/2009 and I feel better except the cramps and diarrhea are worse and very annoying, and I am grounded for the weekend.  Note that I also had a Pneumovax injection on Friday 10/16/09 in the opposite arm at ~4:15 PM given by the RPH. I have not eaten anything unusual during this period and had 2 glasses of wine Friday evening.  Note that the CMA who gave the flu shot for Dr. did not give me an adverse reaction sheet.  The pharmacist did.  I suspect it was the flu shot and not the pneumonia shot.  So that is what I am reporting here.  My stool looks rusty and I am concerned for internal bleeding.  I will monitor closely and go in for urgent care if warranted.
I received injection on Tuesday. Wednesday I awoke a bit dizzy, but made it through the day at work. Thursday I awoke a bit more dizzy and almost in sick, but proceeded to work. At 1 pm I was very dizzy and found that I was very easily irritable, which is not like me at all. I felt overwhelming anxiety and felt that I needed to be away from people immediately, so I told my boss "I have to go home, sorry" I made it home safe, at which point on Thursday night I had high fever. I pushed through the night, I took 3 ibuprofen for the headache that was rising. I got some sleep Thursday night and awoke Friday morning still dizzy but thankfully no fever, at which point I called the drs office that administered the shot and they referred me to contact you, please help. call.
Breast cancer, metastatic to lymph node. Within about 6 weeks of administration patient noticed skin changes of breast and lump. Mammogram confirmed a spiculated mass. Surgery confirmed invasive carcinoma with mixed ductal and lobular features; margin positive for invasive carcinoma, with lymphovascular invasion and positive lymph node. Patient did previously have an abnormal mammogram previously however no clinical signs of cancer were present until the vaccine was given. It is thought that perhaps the vaccine would have accelerated the course of previously existing breast cancer.
Headache; the patient was pregnant at the time of vaccination, gestational period was 23 weeks; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 18Dec2020 19:45 at single dose for COVID-19 immunization at a hospital. For the patient's medical history, no allergies to medications, food, or other products. For concomitant drugs, no other medications was received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and since the vaccination, the patient been had not tested for COVID-19. It was reported that the patient was pregnant at the time of vaccination, gestational period was 23 weeks. The last menstrual date was reported as 08Jul2020. The patient was due to deliver on 14Apr2021. On 19Dec2020 19:00, the patient experienced headache. No treatment was received for the event headache. The outcome of the event headache was recovering.  Information on the lot/batch number has been requested.
Patient had chest tightness and grabbing her chest , states her throat feel funny, hard to swallow. Oxygen 99% on room air. 15 min later, her tongue states is numb and chest tightness is worse. Patient grabbing on her neck. Blood pressure was 177/92. Heart rate was 98. Respirations was 18. EpiPen administered and 911 called.  Patient placed on 2L nasal cannula. Patient states shortness of breath, but oxygen at 99% , still states hard time swallowing , and grabbing on her chest.  Switched to nonrebreather mask at 5L.  Blood pressure was 160/91. Heart rate was 88. Oxygen saturation was 100%.  Respiration was 18. Patient left via ambulance, paramedics were present, patient continued to have chest tightness and numbness in extremities and shortness of breath.
Vaccine was expired, expired on sept 21, 2021.  Vaccine was given 12/28/2021
Rash, about 6 inches at site of injection. Red, hot and hard  and swollen.
3 days after shot I developed a rash on my neck, torso ,arms and hands. My thumbs where swollen and numb. I developed a fever ranging from  101 to 104.4 for 48 hours. intense body achs.
New onset first episode Anterior Uveitis with symptoms of photophobia and blurry vision beginning approximately 2 wks status post first dose of vaccine and worsening one day after second dose of vaccine.