chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's relevant medical history and concurrent conditions were not reported. Concomitant therapy included sterile diluent. On 09-FEB-2018 the patient was vaccinated with VARIVAX (dose, frequency and route were not reported) (lot # N012619 and expiry date: 21-APR-2019) for prophylaxis. The nurse reported that, second patient was administered a dose of improperly stored VARIVAX on 09-FEB-2018. The vaccines were stored in temperature 6 degree Fahrenheit (F) to 14 F (7.3F) for 25 Minutes. There was a previous temperature excursion of 6 F to 14 F for 206 minutes. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. The outcome of events was unknown. The relationship between events and VARIVAX was not provided.
Extreme nausea starting at three.  Eased up some by 7:30 pm after eating  some crackers
Swelling/rash on face and body; moderate to severe itch.  Began appearing about 72 hours after shot & has lasted about 14 days.
Patient had vaccines given, 1 in each leg, on 2/5/19 at 7:46 pm. Mom states that the morning of 2/6/19 that the pt developed a fever of 101, and was experiencing swelling and erythema in both thighs around injection site. Today 2/7/19 the swelling and erythema has worsened on the left leg. The right leg experienced no change.
Aproximately 2 hours after vaccination experienced chills then approximately 10 hours after vaccination experience face and neck flushing.  This flushing proceeded throughout the next day intermittently lasting 30 minutes to 1 hour each time. It is described as feeling like a sunburn. Also experienced soreness and dryness in throat 10 hours after vaccination.
Patient had signed up for 2nd Pfizer COVID-19 vaccine and received a Pfizer dose 1 after J&J vaccine. Patient disclosed after she had received the vaccine and mentioned her provider had told her it was okay to receive a 2nd booster.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 07-AUG-2015 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (lot # K018144, expiration date 10-APR-2016, dose, dose# and route not reported). There was no adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
persistent cough, chest pain, shortness of breath, palpitation, heart murmur, chest heaviness
Client reports edema, decreased ROM (unable to raise arm greater than 45 degrees), pain at injection site and in shoulder joint lasting 3-4 weeks.  Reports fever and headache after administration.
The rash peels, is red; itchy rash; the mild rash came back on the right side of her body; This spontaneous case was reported by a nurse and describes the occurrence of RASH ERYTHEMATOUS (The rash peels, is red), RASH PRURITIC (itchy rash) and RASH (the mild rash came back on the right side of her body) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     Concomitant products included APIXABAN (ELIQUIS), EZETIMIBE (ZETIA), FUROSEMIDE SODIUM (LASIX [FUROSEMIDE SODIUM]), METOPROLOL, AMLODIPINE, OLMESARTAN, ALPRAZOLAM (XANAX), DIGOXIN, MULTIVITAMINS [VITAMINS NOS], FISH OIL, VITAMIN E NOS, COLECALCIFEROL (VITAMIN D 3), DENOSUMAB (PROLIA) and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced RASH (the mild rash came back on the right side of her body). On 04-May-2021, the patient experienced RASH ERYTHEMATOUS (The rash peels, is red) and RASH PRURITIC (itchy rash). At the time of the report, RASH ERYTHEMATOUS (The rash peels, is red), RASH PRURITIC (itchy rash) and RASH (the mild rash came back on the right side of her body) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient stated that rash comes back, seems like every two weeks on the right side of her body. Treatment included  Anti-itch Gold Bond Cream, Benadryl 25 mg twice daily. Concomitant medication includes osteo BioFlex.
I started on May 25th with bad chest pain, a week prior I had a bad cough, I went to my doctor, and they did an ECG/was normal at the time and they sent me home. They stated if it got worse, to go to the ER. It did get worse went to the ER later that night, and they concluded that I have inflammation around my heart.  I was I given Meloxicam for inflammation around the heart.
lower back pain that radiated down the legs. occured the next day around 7:30am and lasted until the next day. Treatment: heat and layed in bed.
Irregular heart rhythm, 2 weeks , treatment none  vertigo,  2 weeks, treatment meclizine  minor swelling of the throat,  4 hours, treatment zyrtec   rash over 90% of my body, started 4 after shot, zyrtec helped rash was gone the next day.
covid test result Positive; covid test result Positive; fever; HA; body aches; chills; cough; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 27-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 26Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 27 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 16Feb2021, when the patient was 26-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 27Jan2021, when the patient was 26-year-old, for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 18Apr2022, outcome "unknown", described as "HA"; PAIN (non-serious) with onset 18Apr2022, outcome "unknown", described as "body aches"; CHILLS (non-serious) with onset 18Apr2022, outcome "unknown"; COUGH (non-serious) with onset 18Apr2022, outcome "unknown"; PYREXIA (non-serious) with onset 18Apr2022, outcome "unknown", described as "fever"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid test result Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Apr2022) Positive, notes: Unknown HOME Ag,. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, pyrexia, headache, pain, chills, cough.  Clinical Course: Facility type vaccine: Workplace clinic If other vaccine in four weeks: Unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Vaccination failure and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Approximately 2 weeks post vax the pt developed 10 spots. The pt was reportedly taking birth control pills at the time of vaccination.
Patient start having numbness to the left side of her face on Tuesday after the shots and it has continued and it is now Friday. She has seen her PCP and is following up with them.
received by accident Kinrix vaccination instead of T-Dap; 12 years old patient has received by accident Kinrix vaccination instead of T-Dap; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old male patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were received as follows: The reporter was an office manager. The reporter stated that the 12 years old patient had received by accident Kinrix vaccination instead of TDap which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up.  Follow up information received from an other health professional on 2nd April 2021: Case classification was updated to FU NO Permission Denied.
Patient give Dtap injection on 9/10/09 in L upper arm.  Developed large, hot swollen reaction on 9/11/09.  9cmx11cm in size cool compresses/MOTRIN KRIX.
Next day, pt called to report GI sxs: nausea, upset stomach. Day later, she reported swollen lymph node in armpit of left arm where she got vaccine
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 10:17 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 10:17 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The patient's age was reported as 43.89.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  On 03-Apr-2021, At excursion time 09:00 AM temperature was 34, total doses given for the day was 210, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were moved to clinic. Vaccine BUD date was 29-Apr-2021.  On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. The temperature recordings were taken by using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
Patient reported feelings of pain and extreme soreness in the arm to the extent of not being able to move the arm approximately 4-6 hours post-administration. She reports developing a fever of 101F overnight and a headache.
Within one minute of receiving vaccines I fainted for 1-5 seconds. I responded to the nurse practitioner trying to wake me and within another minute fainted again. I responded to her a second time and was able to regain consciousness.
Vertigo and a feeling of my brain and eyes not being in sync. This symptom went away for 3 months then came back and now I'm being tested for Meniere's Disease. I have hearing loss in my right ear, vertigo about one a week, balance issues frequently, and ear pain, ringing and other noises almost daily.
redness at an angle 2 inches wide and 6 inches long and has increased in size since first noticed but about the same today. Maybe somewhat redder today
pt vax 29OCT92 approx 48 hrs later, exp grand mal seizure; hopsitalized 3 days for complete work-up cardiac monitoring for 3 days revealed no arrhythmias; MRI & CAT scan of brian was nl; EEG-nl pt has no risk factors;
About 9 hours after my vaccine, I developed severe chills for 2 hours and a fever of around 100.1, I also had shortness of breath. After 2 hours, I started experiencing severe body aches (primarily in my knees and back) and a headache, my body temperature felt as thought it was changing from cold to hot frequently, and my temperature rose to 103.6 for about 1.5-2 hours. It finally decreased to about 102 and remained there for about 6 more hours. I had trouble getting up to use the restroom and would feel very dizzy, my temperature dropped midday to about 100. My fever finally broke about 24 hours after my vaccine, but I still lost my appetite and was experiencing body aches and a headache. I couldn't eat anything for about 48 hours after my vaccine, I was able to take small sips of water to help stay hydrated. It took until Saturday (5 days after my vaccine) to feel back to normal. I felt very puffy and swollen the entire week following my vaccine and was very fatigued.
Patient called and told one of our technicians that she received her second shingrix injection and her arm still sore from this shot...she told her we would try to contact our clinical team and get back to her.she received her second shingrix shot on December 1st 2019 I called her back to obtain additional information but I had to leave a message.
A serious investigator initiated study report of trouble breathing has been received from an investigator concerning a 23-year-old female, who is enrolled in the study. Neither medical history nor concomitant medications have been reported. The subject received FLUMIST on 22-Oct-2007. On 27-Oct-2007, the subject experienced trouble breathing. The event was described as "severe" and that the subject "could not work" or do "usual activities". The event was considered resolved on 28-Oct-2007. The study investigator assessed causality as probably related to FLUMIST vaccine. The sponsor considered the event medically important and agreed with the study investigator's causality assessment.
interchange of vaccine doses; Memory loss; Missed second dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine doses), PRODUCT DOSE OMISSION ISSUE (Missed second dose of vaccine) and AMNESIA (Memory loss) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose of vaccine). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine doses) and AMNESIA (Memory loss). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine doses) and AMNESIA (Memory loss) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed second dose of vaccine) had not resolved.
09/30/08 patient complained of hurting feet, 10/01/08-morning patient had swollen right ankle and toes, pruritic rash all over abdomen-pediatrician office said to treat with Benadryl; by evening-patient's feet and hands were so swollen she had trouble moving her standing and moving her fingers-we took her to the ER-they diagnosed Henoch-Schoenlein Purpura; 10/06/08-patient began with GI symptoms with vomiting and she refused to eat or drink for the next 4 days and became dehydrated and we took her back to the ER where they admitted her for 1 day; she improved but has continued to have vasculitis events the next several weeks.  2/17/09 Received hospital medical records for 10/9-10/10/2008. FINAL DX: gastroenteritis & dehydration Records reveal patient experienced HSP 8 days prior w/LE swelling, pain & petechia.  Developed sore throat & seen by PCP 4 days prior to admit.  Throat c/s (+) for strep & started on antibiotics.  Night before antibiotics started, developed emesis x 1 & reduced oral intake since then.  Lost 3.5 # since PCP visit w/decreased UOP.  Tx w/IVF & admitted overnight for observation.  Did well & appetite improved.  D/C to home on continued oral antibiotics w/PCP f/u.
Case number PHEH2014US003178 is an initial spontaneous report received from a medical assistant on 13 Feb 2014. The case refers to a 17 year old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with one dose of MENVEO (batch number: M11082) intramuscularly on 12 Nov 2013. The unreconstituted MENVEO was reached 51 F for up to 17.5 hours. No adverse event was reported following this administration error.
This case was reported by a other health professional via call center representative and described the occurrence of nervous in a adult male patient who received RABAVERT. On 23rd September 2017, the patient received RABAVERT. In September 2017, less than a week after receiving RABAVERT, the patient experienced nervous. On 23rd September 2017, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the nervous and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the nervous to be related to RABAVERT. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by a molecular biologist who worked at a hospital and called on behalf of the  physician worked with. The health care professional stated that a dose of RABAVERT for pre-exposure was administered to the patient in the front of thigh and not in the deltoid muscle, which led to vaccine administered at inappropriate site. The heath care professional stated that the patient became nervous after administration because the patient read the prescribing information. The reporter did not have lot number or expiration date of the vaccine or further patient information.
2 days post 1st dose pt noted flashes in visual field and fatigue.  Inc in flashes after 2nd dose.  Reported dec in visual field 2-3 days post 3rd dose, Inc in flashes and severe eye pains.  Symptoms:  Pain.  Dx Optic Neuritis in 06.  7/31/09 Medical records received DOS 6/13/06 to 2/27/09. Assessment: Optic Neuritis. Quadrantanopsia, myopia, astigmatism. Ischemic optic neuropathy: optic neuropathy of unknown origin. Eye flashes, sharp pain, dull ache. Visual field loss. Visual impairment. Difficulty breathing. Upper respiratory infection. Closed fracture of talus. Viral syndrome. Patellorfemoral syndrome.
Rash over body, puffy (swelling) of feet, hands, eyes. Labs done to r/o other possibilities and instructed to take BENADRYL.
got pain in the arm; fatigue; chills; Vaccinated from a prefilled syringe that surpassed 6 hours; A spontaneous report was received from a pharmacist who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced pain in the arm, fatigue, chills following vaccination from a prefilled syringe that has surpassed six hours.   The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received her first of two planned doses of mRNA-1273 (BATCH # 041L20A) on 02 Feb 2021 intramuscularly in the left arm for prophylaxis against COVID-19 infection.   Pharmacist received first dose on 02 Feb 2020 to left non dominant arm. Pharmacist stated I got pain in the arm, fatigue, chills after the dose. Pharmacist stated they were conducting clinics at hospital site, extra unused doses in syringe were brought back to pharmacy, and being used for administering other patients for last two weeks that were in syringes for over six hours. HCP (healthcare professional) wanted to know how long it can be stable in syringe, as she knew punctured vials needed to be discarded after six hours but what about dose in syringe. Also, she asked if they could transport in syringe to different sites and conditions to maintain for transport when they are in syringes. Approximately thirty patients were administered from those syringes. HCP stated that it was first dose for all patients. HCP does not know any information on those patients except, was one of the recipients of dose of vaccine from that syringe. Consented for safety follow-up with reporter. Pregnancy status unknown, age not provided. No further information was reported.  No treatment information was provided.  Action taken with RNA-1273 in response to the event was unknown.  The outcome of the events was unknown.  The reporter did not provide an assessment for the events, got pain in the arm, fatigue, chills and vaccinated from a prefilled syringe that surpassed six hours.; Reporter's Comments: This report refers to a case of "Expired Product Administration" of  mRNA-1273, lot #  # 041L20A with  associated adverse events of limb discomfort, fatigue and chills. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I bend down to get laundry and then I felt a pop. I stood up and I had excruciating pain. I couldn't move. In the morning I felt a bit better after a warm bath. I went to the doctor soon after and we did an X-ray of my joints and everything was fine.
He presented at ED on 4/22/2021 for 2 days of worsening L sided chest pain. Denied trauma, no recent illness, fever.  Pt stated pain present with deep inspiration, movement.   No recent travel, LE complaints, no DVT / PE hx.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: Patient States her lips got swollen when she got her 3rd covid pfizer vaccine. Patient also mentioned that she had the same lip swelling reaction from either her 1st or 2nd vaccine but decided not to report because symptoms went away. When asked to specify which dose, she could not recall.
Post vaccination the patient had a dizzy spell within 2-3 minutes of being vaccinated and then fainted while seated in the waiting room. She came too moments later and the pharmacist on duty had the manager on duty call 911. EMS arrived within 5 minutes of the call, monitored the patient's blood pressure/pulse rate and temperature. The patient was monitored for roughly 10 minutes, and then left the pharmacy on her own power. She declined a visit to the hospital, signed a waiver from the EMS.