chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 10 minutes of vaccination, pt. experienced facial flushing and swelling that was observed by self and others. Right arm tender, very swollen, bruised.  Friday night face felt hot, swollen.Did not sleep well that night; felt hot, aching all over. Symptoms of feeling hot, swollen continued all weekend. States she thought she must be runny a fever but upon checking found it to be 98.2.Made appt to see MD on Monday 10/27 and was told she had hives over face, chest, back, most likely due to influenza shot. MD recommended benadryl 25 mg STAT and then q 4-6 hrs. until rash resolves. Pt has had numerous flu shots in the past without problem.
Patient had a vasovagal reaction 15 minutes post vaccinations. Patient recovered okay and was able to leave building with mother on his own.
This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (merck) (lot number not provided) doses which were exposed to -6.8C for 1.5 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccines have been moved to a proper storage unit. Follow-up information received from the healthcare worker. Patient information was updated. On 12-SEP-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot#, expiration date and route not reported). This is one of the several reports from the same source. Additional information has been requested.
SICK ON 2-6-22 WITH WEAKNESS AND CONFUSION. TESTED POSITIVE FOR COVID-19 IN THE ER BY PRC ON 2-7-22. ADMITTED TO FACILITY ON 2-7-22 DISCHARGED 2-12-22
COVID vaccine breakthrough case Dose 1          Moderna        4/27/21        047A21A
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 94-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Anti-viral product Paxlovid (Lot number: FX8140) from 06Jul2022 to 10Jul2022 for COVID 19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After returning to school, school nurse called stating  child had hives along left arm where the injection was given. Mother states child then developed hives on face. Went to the ER, and was told that child was probably allergic to Thimersol. No testing done to confirm this.
Itchy rash on face and neck, came on when I woke up yesterday, less than 24 hours after the shot and has worsened to today 4/1/2021
Patient states that her left arm became very sore the evening of the shot and she did not feel well as the hours went by. She slept the night and in the morning woke up and had a difficult time walking due to what sounded to me like orthostatic hypotension. She had to sit down due to feeling so unsteady and she described darkness closing in and going away from her like in a tunnel.  She was able to make it back to bed where she attempted to call her daughter but it took several attempts as she described extreme difficulty punching in her daughters phone number. Her daughter stated that when she received the call her mother was slurring her speech. The patient was taken to the hospital and admitted for overnight. Imaging studies were ordered and MRI of the brain showed a small white speck on the brain that night, the speck was not visible on follow up MRI the following day. All other studies were negative. She states that her sister had the same reaction after her pneumonia vaccine but her sister actually lost consciousness and fell in the bathroom, patient did not lose consciousness as far as she knows and she did not fall
vasovagal response, pt fell and hit his head, pt was okay, ambulance came but he did not leave with them
Admelog vials, lantus Vials, Lantus solstar, Toujeo, Flublok, Fluzone QD PFS, Typhim Vi and Apidra vials exposed at 46-53.5 deg F for 13 hours. Excursion happened when refrigerator door was not closed fully with no AE; Potential PTC:No Description:Rph wanted to gather stability information on Admelog vials, lantus Vials, Lantus solstar, Toujeo, Flublok, Fluzone QD PFS, Typhim Vi and Apidra vials exposed at 46-53.5 deg F for 13 hours. Excursion was happened when refrigerator door was not closed fully. Caller refused to provide the Lot# of the products. Additional Description of event Adverse events :Rph wanted to gather stability information on Admelog vials, lantus Vials, Lantus solstar, Toujeo, Flublok, Fluzone QD PFS, Typhim Vi and Apidra vials exposed at 46-53.5 deg F for 13 hours. Excursion was happened when refrigerator door was not closed fully. Caller refused to provide the Lot# of the products. Clarification note: Kindly reassess and delete suspect drugs if not required at step as it was not clearly mentioned if patients was using the reported drugs. Update outcome as not applicable.
This spontaneous report was received from a medical assistant refers to an unknown number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored GARDASIL (dose, lot # and route of administration were not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
At 1415, patient reported tingling and numbness to her lips.  No c/o  shortness of breath, tongue swelling or itching.  At 1416- assessed by Dr., lungs clear, no stridor, slight rash to bridge of nose. At 1421- 0.3mg epinephrine IM administered. BP 130/84, HR 84, and O2 at 97% on room air.  At 1431- 25mg  IM of Benadryl given and at 1432, 124 mg of Solu-Medrol administered IM.  Patient's vital signs continued to be monitored and remained stable over the next hour. At 1525, patient was reassessed by Dr. and was able to be discharged from clinic.  1540 - Patient's son picked her up and took her home with instructions for a competent adult to remain with her for the rest of the evening.  Patient had an Epi-pen at home already and was instructed to use and call 911 if additional symptoms.  The following day, patient was contacted by clinic Provider .and reported feeling fine and no new symptoms.  On the morning of 3/11/21, patient called clinic with onset of facial swelling and shortness of breath. She was advised to go to the ER.
This prospective pregnancy case was reported by a nurse and described the occurrence of vaccine exposure during pregnancy in a 29-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). The subject's medical history included 1 full-term pregnancy. On 13 May 2014, the subject received an unspecified dose of BOOSTRIX (intramuscular, administration site unknown). The last menstrual period was on 17 October 2013 and estimated date of delivery was on 24 July 2014. The subject was exposed to the vaccine during the 3rd trimester. At the time of reporting, the pregnancy was ongoing. Follow-up information received on 01 October 2014 from nurse: The subject received dtpa vaccine at week 29 of the pregnancy and during the third trimester of pregnancy. The VAERS details were provided. Some of the patient's details were updated. This has a normal conception pregnancy. Follow-up information received on 10 November 2014 from nurse: After 39 weeks, the subject have birth to a female neonate via vaginal delivery. The pregnancy resulted in a live neonate with no apparent congenital anomaly. The neonate weighed (8lbs 18oz) at birth. APGAR scores 9 and 9.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.   No Medical History information was reported.    On 02-Nov-2021 at 3:55 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. Storage condition at the time of the excursion: frozen storage. Excursion duration was 1 month. 19-Nov-2021 was when the Moderna COVID-19 vials went from the super cold freezer to the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursions. Treatment information was not provided.
After getting covid I had ringing in the ears, fatigued, shortness of breath, and sinus congestion. I also lost my sense of smell and taste. When I went to the doctor he prescribed me Decadron for 9 days. I also had the monoclonal antibody infusion on 11/11/2021. I still have the ringing in my ears since having covid.
Strong heart palpitations Shortness of breath  Chest pain  Fatigue  Symptoms started on a minor scale a week or so after the second dose 5/19/2021.  Symptoms could no longer be ignored on 10/17 do to there increase in severity.   Check in to Hospitals ER on 10/20/2021 about 3pm.   Test administered- Cardiac MRI, CAT scan with and without contrast, EKG, Chemical Stress Test, Angiogram, after all possible testing was done.   Scientific Pacemaker/ICD implanted on 10/27/2021.
got my Shingrix shot in 2018,; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd shot of Shingrix, which led to incomplete course of vaccination. The patient asked that he/she need another shot. The follow- up could not be possible as no contact details were available.
I was going into the patient's room to administer shots to her and her sister. Her sister was getting the Hep A and flu and pt. was just getting the flu. They wanted the older sister to go first, and I grabbed the Hep A vaccine by accident and gave it to the older sister instead of the younger sister. I told the doctor and she went in to speak with them and everything was fine. No adverse reactions.
This spontaneous report as received from a medical assistant refers to a 19 month old child patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 01-OCT-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868; US-009507513-1902USA009324:Original Case : 1902USA009323; US-009507513-1902USA009325:Original Case : 1902USA009323; US-009507513-1902USA009326:Original Case : 1902USA009323.
Chills first thing in the morning followed by dizziness, temperature was 100.1, then vomiting.  Chills lasted approximately four hours.   Fever lasted about four hours.  Vomiting lasted about 15 minutes, then body aches and severe weakness lasted throughout the rest of the day .
Patient said he developed redness that spread from his shoulder to his back. He has been having a rash for a month since a day after the immunization.
Tickly throat, itching all over, stomach pain, flushed, urticarial rash over trunk, arms, legs 40 mg Benadryl 1116 Zantac 75mg 1130 EPI JR 1202 V/S Q 10 mins. Discharged Home 1520.
Information has been received from a physician concerning a 11 month old male who was vaccinated with his third dose of RECOMBIVAX HB. Concomitant therapy that day included the frost dose of FLUZONE. Ten minutes post vaccination the child developed hives on his face, chest and extremities. Medical attention was obtained. Treatment was 3/4 teaspoon of BENADRYL. The final outcome was unknown at the time of this report. No further is available. No associated quality complaint report.
Starting the Friday after the vaccine, I got nauseous and dizzy and this lasted all day. I woke up the next day with a runny nose and later that day developed a scratchy throat. The next day, I tested myself for COVID-19 at home and it was positive. I contacted my doctor the next day (on Monday) and she prescribed me PAXLOVID. I started it that evening. The fever was bad at this point. It took a few days before I started getting some relief. By the time the PAXLOVID was done, I felt better. However, it took a total of 2 weeks to stop testing positive for COVID-19. To this day, I am still experiencing fatigue and lethargy. Its been hard to even do normal daily activities without being tired out.
Date of vaccination (4/28), fever of 102 F, resulting in loss of sleep.  A week later (5/03), singular hives began to appear on arms and legs, resulting in loss of sleep. Much worse the next day (5/04)- clustered hives accompanied with burning rash all over arms and legs. Benadryl anti-itch cream only enflamed them more. Vomited the next morning (5/05) and made an appointment with healthcare clinic, despite hives and rash subsiding overnight. Doctor ruled vomiting as an effect of prescription medication, but rash and hives as a result of a reaction to the vaccine. Next day and the day after,(5/06-5/07), had a few single hives appear on body. Haven't had any more appear since then, and I've felt fine.
THUMB & INDEX FINGER NUMBNESS; SORE SHOULDER AT INJECTION SITE Narrative:
Increased erythema, warmth and tenderness of upper (L) arm 4 3/4 X 2 1/4 which developed 3 days after KINRIX vaccine.
I am fully vaccinated; I have COVID; I am fully vaccinated; I have COVID; This is a spontaneous report received from a non-contactable consumer (patient). A patient of unspecified age and gender received the first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Numbers: Unknown) both via an unspecified route of administration on unspecified dates in Feb2021 (dose 1) and Mar2021 (dose 2), both as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient reported that she was fully vaccinated and had COVID, on an unspecified date. The patient called to report that she received the Pfizer vaccine and was fully vaccinated. The first shot was in February and the second one was in March, and now the patient had COVID. The patient wanted to know how long this would last before they got over it. The clinical outcome of the event I am fully vaccinated; I have COVID was unknown.   No follow-up attempts are possible; information about lot number cannot be obtained.
Rash on leg started a day after IPV and Dtap vaccines in the same leg.  It is warm and a little itchy.  Not too sore.  It seems bigger today
This spontaneous report received from a patient via the regulatory authority, concerned a patient of unspecified age and sex. The patient's height and weight not reported. No past medical history, concomitant medications or concurrent conditions reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch/lot# unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. On an unspecified date, patient experienced body aches and nausea. The action taken with COVID-19 vaccine ad26.cov2.s: Not applicable. The patient recovered from body aches and nausea. This report: non-serious.
This spontaneous report as received from a health worker refers to an unspecified amount of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of ROTATEQ (lot #, dose, route, not reported that underwent a temperature excursion on an unknown date. Concomitant therapy was not reported. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
A lot of pain and redness in arm day of vaccine. It subsided 2 days later. 6 days after vaccine redness and itchiness returned.
tested positive greater thatn14 days post fully vaccinated  Narrative: tested positive great than 14 days post fullu vaccinated
Resident received 2 Bivalents, Moderna - 3 months apart. Bivalent 1 on 10/05/2022 (lot #AS7165B) and Bivalent 2 on 01/05/2023 (lot #AS7171B). No adverse ill effects noted. Notified attending PA-C and Pharmacist Consultant no recommendations for treatment, but to monitor resident for potential, common, adverse effects.
HIVES WHICH STARTED DISTALLY ON BOTH UPPER AND LOWER EXTREMITIES THE FOLLOWING EVENING  07/28/18. INITIALLY SYMPTOMS RESOLVED WITH BENADRYL BUT HIVES RETURNED FOLLOWING DAY.
I?ve always had an occasional heart palpitation but ever since my second moderna dose I?m have constant palpitations.I also skipped my period for a month,along with serious fatigue now.
My Daughter turned one is September. Received proquad MMRV At one year check up. 9/21/19. Turned 15 months in December and received another dose of proquad  12/27/19 which stated from manufacturer, CDC, as well as paper handed to me that day, she should not get another dose until age 4-6. Roughly Two weeks later she woke up in the night scratching her head ( 1/10/20) by the morning 1/11/20 she had a rash on her front torso At 830 am. By 930am it was spreading and all over her back. Gave Benadryl baby napped woke up at 12pm no change. Rash still present and spreading. 130pm called pediatrician as it was progressing and he stated it is ?probably viral and can?t do anything for it? also stated that the virus he administered ?wasn?t live so it won?t shed?. By the night her body was taken over by the reaction. Up her back, neck, private area, and stomach/chest. Gave Benadryl again to help Alleviate any discomfort. By the morning 1/12/20 it had spread all over her face legs arms and now her whole body was in a full blown rash. Called the doctor again and he stated there?s nothing to do for it to stop giving her Benadryl still did not see her nor did he think it was an issue.  Brought her to the ER around 230pm and the first thing we were asked was when did she have her MMR shot last. the nurse said she shouldn?t have gotten her second round of proquad until age 4-6. ER Doctor came into hospital room and would not comment on the vaccine mistake. Kept mask on whole time as well as all the other staff. Doctor ordered two injections into each leg. One a steroid and one a dose of Benadryl. Rash started to calm down but did not go away. Dr. prescribed us steroids to bring home and give my daughter twice a day for five days. Prescription was filled but not given. Called the pediatrician in the morning 1/13/20 he said to not give her the prednisone or the Benadryl because he did not believe it would help her. I advised and did not give her anything for it. she had the body rash until Thursday 1/16/20 along with a fever of 99.6-100 from 1/11/20-1/16/20. Her skin is now bumpy and feels like sandpaper from this adverse reaction.    I have photos as well as documentation.
Swelling and stiffness of arm & injection site, headache, muscle aches, chills, fever of 100 degrees for 2 days, fatigue.    Fatique, muscle aches,  lasted 5 days  along with arm swelling .
Information has been received from a physician concerning a child pt with a history of eczema who was vaccinated SC with a first 0.5ml dose of varicella virus vaccine live. There was no concomitant medication. A few days post vaccination, a rash broke out on the face and neck area. The pt was seen by a dermatologist and was diagnosed with atopic dermatitis. Lab tests were not performed. The reporting physician was not sure if varicella virus vaccine live caused this because the pt had a history of eczema. It was noted that therapy with varicella virus vaccine live was discontinued. A product quality complaint was not involved. Additional information has been requested.
CLIENT STATES SHE WAS FEELING WARM, DIZZY, AT 10:45, STARTED TO SWEAT AND STATED THAT SHE HAD A 'FROG IN HER THROAT' AND STARTED TO GASP.  10:47 0.15 MG OF BENEDRYL GIVEN IM IN R THIGH  AND EMS WAS CALLED CLIENT SP O2 IS 88%, CLIENT REPORTS BEING NAUSEAOUS AND SHAKING THROWS UP SMALL AMOUNT OF FOAMY CLEAR FLUID. CLIENT SP 02 IS 98% EMS ON SITE, TAKES CLIENT TO ER VIA AMBULANCE. LEAVES CLINIC BY 11AM APPROXIMATELY CLIENT GOES TO ER
Heart irregular rhythm  with PVCs Started occasionally 2 weeks previous and became more frequent and consistent on 5/20. Some shortness of breath and palpitations Sought evaluation and treatment at Hospital Emergency.  Treated with IV fluids, non life threatening. Discharged home.  Continue with symptoms.
Swelling, tenderness, and itching near the injection site. The symptoms became significantly worse 9 days after the initial injection. At that point, my arm became hot to touch and severely itchy. On day 10 the symptoms began to subside and were manageable with tylenol and an antihistamine.   The second dose resulted in a similar reaction to the vaccine as the first dose. The symptoms were worse and included, headaches, exhaustion, muscle and joint pain to the point where I had to call out of work. The body aches felt similar to having the flu. This all occurred the day after the second dose. Two days after the second dose,  I am still tired and have a headache. The body aches are minor.