chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist concerning 71 years old female patient without drug reactions or allergies. (pertinent medically history was not reported). On 02-NOV-2012, the patient was vaccinated with a dose of PNEUMOVAX23 (lot H010515 exp 13-FEB-2014) intramuscular (dose and indication were not reported). No other co-suspects were reported. No concomitant medications were reported. On 03-NOV-2012, the patient developed a fever, pain and decreased arm mobility after receiving PNEUMOVAX23. The patient was treated with ice and TYLENOL. Laboratory tests were not performed. At the time of report, the patient had not recovered from fever, pain and decreased arm mobility. Additional information has been requested.
This spontaneous report was received from a medical assistant regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patients were vaccinated with improperly stored GARDASIL (dose strength, route and lot number was unknown). No concomitant medication was reported. No adverse event was reported. No product quality complaint was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Patient given dose 7 days prior to the 28th day by our clinic nurse. No health reactions or symptoms noted.
Received Menactra 8/2/07.  AM 8/3/07, he felt dizzy and weak.  c/o soreness at both injection sites - Right arm more sore than Left arm.  soreness has improved.  Continues to c/o dizziness and weakness, but is improving.
After consulting with patient about allergies and discussing the immunizations, both vaccinations were given in the right arm, with appropriate spacing from each other. The PNEUMOVAX 23 was given first and anterior, with no adverse effects observed. Directly after, the FLUZONE QUAD was administered, and there was immediately bleeding for approximately 10 to 20 seconds, swelling, and redness at the injection site. The patient denied pain or discomfort, right after the injections, and also after 10 minutes of observation. I was unable to locate the immunization room ice pack, but the patient wanted to use her ice pack on the area once home, so I suggested she apply her ice pack to reduce swelling.
ON SATURDAY EVENING, STARTED WITH CHILLS AND FEVER. BY SUNDAY MORNING, HE WAS THOSE 2 THINGS PLUS NAUSEA/VOMITING AND A MAJOR HEADACHE.  HE SAID HE TOOK 3 BAYER ASPIRIN BACK AND BODY TABLETS AND STAYED IN BED ALL DAY. HE ALSO TOOK 1 REGLAN 10MG TABLET TO CALM HIS STOMACH. BY MONDAY HE WAS FEELING MUCH BETTER, JUST TIRED.
Patient was receiving FLUVIRIN 0.5ml, IM injection.  Patient pulled away and only got partial injection.  The rest dripped down her arm.
11/26/99 - Arm swelling and sore.   11/27/99 - ER visit, arm red, swollen, and fever.  Antibiotics prescribed.  12/1/99 - Recheck in office, pt improving.
ER visit after injection, with itching/rash  Nausea/Vomiting/Diarrhea    Allergic reaction secondary to flu shot uticaria rash. Moderate rash   Pt. did fill out and sign a questioner / Informed consent. form does not list flu vaccine or eggs as on allergy. Pt did not say anything to staff giving injection r/t having had an adverse reaction to flu vaccine in the past.
Day 1: Hives appeared on hands a couple hours after the shot but didn't itch. Arm was sore. Day 2: Hives itched and had a fever of 100.3. Arm was very sore. Fever went away by the end of the day. Day 3-Day 7: Hives stuck around but no itching. Only on hands. Arm pain went away after day 3. Day 8, nearly to the exact hour of the shot: Small (nickel sized), itchy red bump at injection location. By the end of the day it had grown to quarter sized, bicep was very swollen. Hives still on hands. Day 9 (today): Red splotch has grown to a bit bigger than a golf ball. Doesn't itch at all but it hurts like the initial shot pain. Bicep is swollen and hot to the touch.
Severe vomiting and diarrhea. 100.4 fever. Vomiting stopped after approximately 7 hours.
pt recvd vax & c/o that the area around inj became hot, swollen & itchy;
Pt stated that late in evening her arm became sore hot swollen. And became increasingly painful starting from lower injection on right arm.
large induration approx 8 am mottled redness patchy areas length of upper (Rt) arm noticed at hosp. 11-6-07 pain increased, ice x 2 1:30 pm/ 6 pm
After patient received his Janssen (J&J) vaccine, he was directed to sit for 15 minutes in front of our pharmacy area. Within the first minute of sitting down,  another patient of the pharmacy who was standing by saw him and said he "didn't look good" and grabbed my attention. He fainted while in the chair for a few seconds, then regained consciousness. When I was next to the patient, I asked if he could hear me and feel my touch when I grabbed his hand, and he said yes. He began (and continued) sweating profusely. He said he had chills but was able to breathe normally. He began to turn a pale yellow/white in color. He lost consciousness a second time and began seizing for roughly 10 seconds. After regaining consciousness again, he was very flushed in the face with a faster pulse. He asked if he could lay down. I gave him ice for his neck to cool him down and had him lay down on the floor until paramedics arrived (verified this was okay with operator on the phone). He said that made him feel a lot better. I was informed he was not allowed to eat or drink anything per operator. Paramedics arrived and took him to the nearest hospital. Time course of roughly 30 minutes or less.
Hives across both legs & buttock began last night 10-20-10 on (L) leg near injection site BENADRYL is being used.
p/recv vax pt fainted in chair, eyes closed, slight drool out of mouth. came around when name was called.
Vaccination 11/10. Appendicitis developed contemporaneously. Appendix ruptured 11/20. Emergency appendectomy 11/24.
still experiencing swelling at the injection site.; This spontaneous report has been received from a nurse referring to a non-pregnant 43-year-old female patient. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not provided.      On 21-APR-2022 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliters (ml) in the right deltoid, lot number U008316 has been verified to be a valid lot number, expiry date 15-AUG-2023 (strength and vaccination scheme were not provided) for prophylaxis.     On the same date,was experiencing swelling at the injection site. The patient sought medical attention; however, no treatment was given for the adverse event.   At the time of reporting, the patient was not recovered from injection site swelling. The causal relationship between the aforementioned event and the suspect vaccine was not provided.
With days of the shots PT was crying all the time, banging his head w/his fists and bled from the nose. This went on for approx 2 weeks.
Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; This is a spontaneous report from a contactable other hcp. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:ek9x31 and expiry date unknown), intramuscular on the right arm on 05Jan2021 11:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included pneumonia, bronchitis and sinusitis from an unknown date and unknown if ongoing. Concomitant medication included ethinylestradiol, norgestimate (TRI-SPRINTEC), fish oil (FISH OIL) and olly womans multivitamin. The patient experienced dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site and chills on 06Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Jan2021.  Therapeutic measures were taken as a result of the events. The patient was advised to rest for 2 days and take Tylenol. The outcome of the events was recovered with sequelae.
Warmness at the site of Injection; Pain at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warmness at the site of Injection) and VACCINATION SITE PAIN (Pain at the site of injection) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warmness at the site of Injection) and VACCINATION SITE PAIN (Pain at the site of injection). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Warmness at the site of Injection) and VACCINATION SITE PAIN (Pain at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.    Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: No specific follow-up information recorded.
It was discovered that the pharmacist administering the vaccine on 10/21/22 had improperly diluted the vaccine resulting in a higher than recommended dose due to improper dilution. Tried contacting the patient on 10/24/22 but no answer. Contacted the primary care physician to let them aware.
I felt tired and had a slight headache the day after the injection, hot and cold, mabe fever? About 48 hrs after the injection I felt very dizzy and went to bed. At hour 60 upon wakening I had extreme vertigo. I  felt as if I would pas out unless laying down. Each time I got up I could not walk straight and had to hold on to the walls. I felt slightly nauseated. This vertigo was very different from the "normal" BPPV I have  experienced over a dozen times. The vertigo episodes I normally get resolve a bit when I am sitting or standing and get worse when I lay down. This vertigo was the opposite. I couldn't stand up or walk with any feeling of control/safety. By the 5th day I felt tired, but had no vertigo or nausea.
Redness/swelling to site of injection (Lt arm) 6 x 6cm to left arm.
I ended up in the hospital 6days after my booster, with elevated Troponin levels HOWEVER, THEY FOUND NO DAMAGE to my heart.   I was exhausted the day after my vaccine, 09/21 continuing through the weekend when I started vomiting and became disoriented.  The next day i went to the hospital and upon checking my Troponin levels, they were found to be elevated,  This led the docs to believe I was having a heart attack or a stroke.  I HAVE NEVER HAD A HEART PROBLEM and am in good health.  The did learn I had a UTI, HOWEVER, troponin levels do not elevate with a UTI, and the docs were not worried about my UTI.  They have not been able to find any reason for the elevated Troponin levels.  During this stay in the hospital and these elevated Troponen levels (.20, .28, .29, .21) I had a plethora of tests, all indicating my heart was not damaged... echocardio, 2 EKG's, a brain scan, constant heart monitor machine, and maybe more tests.   Two days after being discharged from the hospital, I had a stress/cardio profusion test and when meeting with the cardiologist and he looking over all of the tests, she said my heart is in excellent condition and shows NO SIGNS OF of any heart damage, or signs of a stroke or heart attack.   There has been nothing found to explain the elevated troponin levels, and now that I'm ~2wks past all of this, my Troponin level is back down to <.02.
used sterile water / when reconstituting with / lyophilized conjugate vaccine component; used sterile water / when reconstituting with / lyophilized conjugate vaccine component; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA521A, expiry date 30th April 2022) and (batch number AMXA521A, expiry date 31st October 2022) for prophylaxis.   On 12th August 2021, the patient received Menveo (intramuscular). On 12th August 2021, the dose was an unknown dose. On 12th August 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The nurse reported that she used sterile water instead of the liquid conjugate vaccine component (Vial 1) when reconstituting with MenA lyophilized conjugate vaccine component (Vial 2) of Menveo, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The patient received the vaccine in left arm. The reporter would like more information on what signs to look for in case of a reaction. The reporter consented to follow up.
My left arm was red, hot, painful, and swollen. There was also a red rash at the injection site.
difficulty breathing; started feeling warm & progressively got hotter; Felt jittery; shaky; heart rate increased; Felt dizzy as I was walking; started getting fidgety; hands and feet felt tingly; felt like I was burning up inside; Then started sweating/ neck and arms were wet w/sweat; experienced chills; felt nauseated; Tried throwing up; This is a spontaneous report from a contactable other HCP (patient). A 29-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL9261) via an unspecified route of administration on 25Jan2021 at 13:00 (at the age of 29-years-old) in right arm as a single dose for covid-19 immunization. Medical history included crustacean allergy from an unknown date and unknown if ongoing. The patient did not receive any vaccine on same date or any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19. Concomitant medications received in two weeks included methylphenidate hydrochloride (METHYLPHENIDATE HYDROCHLORIDE) and fluoxetine (FLUOXETINE) both taken for an unspecified indication, start and stop date were not reported. On 25Jan2021 at 14:15, after 8-10 minutes of vaccination the patient felt warm and progressively got hotter. Felt jittery, shaky, started getting fidgety, heart rate increased, hands and feet felt tingly, then started sweating, experienced chills, and felt hot. She had difficulty breathing with cloth mask and felt nauseated. Se wanted to take mask off so went to rr and felt dizzy while walking. Neck and arms were wet with sweat, felt like she was burning up inside. She tried throwing up. After few minutes, splashed water on face and went back to waiting area. She again felt jittery, racing heart, and chills. She waited for 15 minutes and left. The patient did not receive any treatment. The outcome of all the events was resolved in 2021.  Follow-up attempts completed. No further information expected.
Patient began to develop a hive type rash on his face and abdomen on his way home from the clinic after hepatitis A immunization. He became very irritable and mother described breathing as not normal. Parents contacted the health center and I agreed with his mother that it would be the best to administer Benadryl and have him evaluated at the hospital. His mother could not think of anything else on their trip to town and the clinic that may have triggered the response. He has no history of allergic reactions. He was much improved by the time they got to the ER at the hospital. No treatment was needed and his symptoms were resolving. The attending physician documented allergy to hepatitis A vaccine in patient medical record and prescribed Epinephrine Auto-injector 0.15mg in case of further symptoms. Mother reports patient continued to improve and no further consultation or treatment was needed.
Presented with rash and malaise "since I got my COVID shot". Rash red raised macular t/o body
pain at the injection site; sore throat; diarrhea; tiredness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st received on unknown date).   On 1st October 2020, the patient received the 2nd dose of Shingrix. On 2nd October 2020, 1 days after receiving Shingrix, the patient experienced injection site pain, sore throat, diarrhea and tiredness. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the sore throat, diarrhea and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, sore throat, diarrhea and tiredness to be related to Shingrix.  Additional deatils were provided as follows: The patient was vaccinated with Shingrix. The reporter was patients daughter. The reporter stated that her mother complained of pain at the injection site but the daughter did not know which arm her mother had the injection. The patient also had tiredness, diarrhea and sore throat. The reporter wanted to know how long these would last, because the pain in her arm had subsided. The patient would talk to her doctor on reporting date. The reporter was also vaccinated with Shingrix. The reporter did not consent to follow up.
Chills; Fatigue; Couldn't sleep; This is a spontaneous report from a non-contactable consumer, the patient. A 17-year-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 in the arm left on 03Apr2021 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included depression, anxiety, tremor and COVID-19, diagnosed prior to the vaccination. The patient had no known allergies. The patient received unspecified medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, the patient experienced chills, fatigue and couldn't sleep. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, fatigue and couldn't sleep was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received vaccination 11/13. Fri 11/14 late night pain and swelling left axilary. Sat 11/15 extreme tenderness and swelling lymph nodes left axillary. No fever, no rash. Injection site okay. No soreness.
Vaccine was initially stored in the refrigerator on 15-Jul-2022 and administered on 17-Aug-2022; No adverse event; Received expired 2nd dose after 30 day beyond use expiry date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired 2nd dose after 30 day beyond use expiry date), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 15-Jul-2022 and administered on 17-Aug-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Aug-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired 2nd dose after 30 day beyond use expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 15-Jul-2022 and administered on 17-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired 2nd dose after 30 day beyond use expiry date), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 15-Jul-2022 and administered on 17-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received expired 2nd dose after 30 day beyond use expiry date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 15-Jul-2022 and administered on 17-Aug-2022).    Patient received the second booster dose.  Concomitant medications details were not reported by the reporter.  Reportedly 4 doses and 3 vials were  initially stored in the refrigerator on 15-Jul-2022.  The vials did not undergo any temperature excursions.  Treatment details were not reported by the reporter.
March 22: Vaccination site becomes red and inflamed March 23: fever (101.3), chills, body aches, dry cough March 24: Covid Rapid test - Negative, Covid PCR test - Negative March24-present: Fever , bodyaches, lethargy, cough continues
Client had no s/s or adverse reaction after 15 min of monitoring. Client received a full third dose rather than a booster due to his second dose not being on Immunization Registry. Client was able to find old card with second dose which resulted in a full dose being administered.
This spontaneous report was received from a register nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 14-JUL-2014, the patient was vaccinated with ZOSTAVAX (strength reported as 19400 PFU), lot # J004267, expiration date 12-JUL-2014, 0.65 ml, subcutaneous. Co-suspect and concomitant therapies were not reported. The register nurse reported that on 14-JUL-2014, a patient received an expired dose of ZOSTAVAX. No adverse effects reported. Additional information has been requested.