chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported; first dose of V AQT A on 12/2/2020 and the booster dose on 5/25/2021 which was a week sooner than 6 months; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 02-DEC-2021, the patient was vaccinated with the first dose of hepatitis A vaccine, inactivated (VAQTA) 0,5 milliliter, lot # T013546, expiration date 28-OCT-2021 (route of administration and anatomical location not provided). On 25-MAY-2021, the patient received second dose of hepatitis A vaccine, inactivated (VAQTA) 0,5 milliliter, lot # T013546, expiration date 28-OCT-2021 (route of administration and anatomical location not provided) (inappropriate schedule of vaccine administered). Both vaccines were administered for prophylaxis. No additional adverse event was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013546; expirationdate: 28-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-MAR-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R010369, expiry date 25-MAR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Does not feel very well; This is a spontaneous report from a contactable consumer (patient herself). A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0183) via an unspecified route of administration, administered in left arm on 11May2021 10:45 AM as 1st dose, single for (receiving for COVID like everyone as reported) COVID-19 immunisation at Hospital. The patient medical history and concomitant medications were not reported. It was reported that patient stated she received her first dose on 11May2021 and was supposed to receive her second vaccine today. She stated there was no problems from the shot she just doesn't feel very well in 2021 and wanted to reschedule for another day this week. Patient stated the problem was with her not the shot. The outcome of event was unknown.   No follow-up attempts are possible. No further information is expected.
Nov 16 - Nose/face blotching redness swelling, pox. Nov 17 - Swelling in neck (mild). Nov 12- Quarter sized bruise at injection site (just below deltiod). All sx still present now at 11.20.14 9 pm.
Within 1/2 hour I could not lift my left arm after pneumonia shot (it took 4 days before I could use it) then my jaw on left side became sore and locked up enough that I could not chew. Went to a ready care unit and they felt it was a part of the adverse reaction and they put me on a antibiotic. That has been over a week and I'm barely able to chew a little on (R) side only. I've had a pneumonia shot before and didn't have a reaction.
erythema & swelling @ site of vax;1SEP95 no addl info recvd;
From 2/25 3:30  p.m. - through friday 3:30 p.m. headache, dizziness, chills,nausea, body-aches, fever, fatigue.  Treate with Tylenol, hydration, and sleep. Sunday 12:30 a.m.  -sharp pain and constriction in upper right sude of chest that lasted about 2 minutes. Took baby aspirin  Never experienced that pain before. No other symptoms.
Moderna COVID-19 Vaccine . The tops both big toes itched like poison ivy.  Redness on big toe knuckle. Symptoms eased 4/10/2020, but still red and mild itching.
Cellulitis (L) arm - pain, swelling, redness. Received injection of DECADRON and ROCEPHIN.
Swollen tongue with lesion, extreme fatigue, muscle aches, vision disturbances, stomach issues, elevated liver enzymes
Swelling,pain,redness at injection site. Fatigue, muscle and joint pain, fever, chills, nausea and vomiting, dizziness
last vax approx 7yr ago;no problem;9hr p/vax pt noticed swelling in both feet, ankles & eventually progressing to mid calf;temp t103;areas under 2nd toe & both feet have broken skin & peeling;noted ankles & feet still edematous;
RECEIVED EXPIRED DOSE OF VACCINE; This spontaneous report received from a pharmacist concerned a 49 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 211A21A expiry: 14-DEC-2021) dose was not reported, administered on 30-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-SEP-2021, the patient experienced received expired dose of vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received expired dose of vaccine was not reported. This report was non-serious.
Small amt of swelling started the evening of the vaccine but when woke up the next morning it had progressed to below the elbow per great grandmother. She gave TYLENOL and used ice pack. She called and we discussed arthus reaction as listed on VIS sheets she had as possibility. Offered that she could bring him here to see a practitioner or take him to his doctor. Doctor told her to continue icing on and off and gave Hydroxyzine 10 mg 1 tsp 3 x day. She said he told her a child should never receive two vaccines in the same limb.
First two days fever up to 103, extreme body aches and chills, excessive sweating, fatigue.  Days 3-6 runny nose, body aches, extreme dehydration, fatigue,.  Days 7-16 continued feeling of dehydration/dry mouth, sporadic body aches, shakes and dizziness with strenuous activity, and dry crusty painful nose ongoing currently.
This is a spontaneous report received from a contactable other HCP. A 56-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# ER8730), at the age of 56, intramuscularly, in left arm, on Apr 13, 2021, at 08:30, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The following information was reported: vaccination site discomfort (slight discomfort at injection site for two days post vaccine), onset Apr 13, 2021, at 08:30, with outcome of unknown. It was unknown whether patient was diagnosed with COVID-19 prior or since vaccination. It was also unknown, if patient received any other vaccines within 4 weeks prior to the COVID vaccine. No follow-up attempts possible. No further information expected.
After I took the vaccine I had typical body aches, headaches, night sweats, chills, and exhaustions. They ressolved within 24 hours. In July 5th 2022 I contracted COVID. I had a severe headache, body aches, muscle pains, low grade fevers, chills, cough, sore throat, and runny nose, and diaherra. On July 8th I was given prescription for Paxlovid and all my symptoms by the 9th and 10th were gone. Today I am having very mild cold symptoms.
I was just very tired and sleeping 14 hours a day. That's unusual for me and I had general malaise and not feeling right. That lasted for a couple of days and thought I was getting a cold. I had a cough and runny nose and was using my rescue inhaler. After 5 days, my cold wasn't going away and my husband said he was getting sick too. We went and got COVID-19 tests, and mine was faintly positive. I called my doctor and we did a virtual visit. I told her that I still had my taste and smell, but I'm just very tired and don't feel well. She said that it was definitely COVID-19, and she said I needed to get a chest x-ray just in case because of my asthma. I went to the urgent care and got my x-ray there and also had a PCR test. That came back positive, and the x-ray looked about the same as any other x-ray I've had before. I stayed out of work for a week, and I still had a runny nose and cough. I did get a little better and slept 10-12 hours instead of the original 14. It was not what I was expecting COVID-19 to be. It was a relatively mild case. I still have a runny nose and cough but it's no where near what it was. They noted that it was most likely a variant and not the original COVID-19 infection.
This is the second year in a row this happened to me.  First incident was exactly the same in October 2010.  Arm of injection site sore, which continued to worsen and resulted in limited rotation of shoulder and searing pain for a year. Went to doctor in 2010 and saw no arthritis or any other reason for frozen shoulder. Gave cortisone shot which did not help.  Pain lessened by fall of 2010 and was almost back to normal until my next flu shot in 2011 where the same thing happened again.  One year of searing shoulder pain and limited rotation/mobility.  I was prompted to research this again as my work recently offered flu shots again this year.  I opted not to get a flu shot this year to test it out a third time and endure another year of pain that no one can figure out/provide relief for.  I'm actually feeling good now, one year post vaccination.
Just before the 20th of December, my wife cut a hair inside of my ear. I had an infection in that hair follicle it seems. For several days afterwards, I had some swelling in my ear and I put some cream on it. And by the 26th I started feeling pressure in my ear. Not sure if I have an ear infection, or swelling in the ear that was caused by that hair follicle. I went to see the doctor on the 28th and was told I did have an infection. I was given an antibiotic. By January 11th, it was still bad. I went to a walk in clinic and flushed it and got some things out of the ear drum and thought they got all of it. But it continued to be swollen and full of fluid. I ended up going again and was given more antibiotics. I feel like the pressure has backed off a bit however I feel it so deep in my ear drum. I felt like this is worth reporting because I heard so many people in the area have a similar experience in the ear, and if that is the case the hair was not the cause of this.
Pain at injection site that woke me up from sleep; Pain at injection site that woke me upfrom sleep; Mild headaches; Mild low fever; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on 08Apr2021 at 19:15 (Lot Number: EW0158), at the age of 25-years-old, as a single dose for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. The patient did not have any relevant medical history (none). The patient had no known allergies with food, medication or other product. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 09Apr2021 at 04:30, the patient experienced pain at injection site that woke up her from sleep (sleep disturbed), mild headaches, mild low fever and fatigue. No therapeutic measures were taken as a result of the reported events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events pain at injection site that woke up from sleep (sleep disturbed), mild headaches, mild low fever and fatigue were recovering, at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a medical assistant refers to a 11-year-old patient of unknown gender. No information about the patient's medical history and concurrent conditions were reported. On 05-FEB-2016, the patient was vaccinated with an improperly stored dose of GARDASIL lot # K008931, expiry date 04-MAR-2017, (dose and route of administration were not reported). Concomitant therapy was not reported. Administered doses were exposed to the following conditions: temperature of 33 Fahrenheit degrees for 15 hours and 15 minutes. There was no previous temperature excursion. It was not the case of a "data logger". No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required correspondence was received.
Dose administered after temperature excursion; Temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion). On 23-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. The medical assistant had a 2 vials that were in freezer and gone temperature excursion due to a power outage. Hcp said that  fridge had a temperature excursion but not the freezer as the alarms never went off for the freezer.  Shipment received for those 2 vials was more than 24 hours.The date of temperature excursion was 17Jul2021.1 vial opened and punctured on 23Jul2021 and 5 doses were administered from it. Treatment medications was not provided by the reporter
11/9/99 - injection site began to hurt, 11/10/99, awakened feeling fatigued.  Shortness of breath with exertion.  Itching at site of injection.
Dr prescribed The injection nurse stated that my arm would be a little swollen and painful for a day or so, but I noticed the reaction right away but waited til the 2nd day then I called the advice nurse who told me to put cold compresses on it (my arm) & if it was no better or gets worse to call and make an appointment. By then it was the weekend; I text Dr. to let her know what was going on. Dr. was on vacation and Dr. responded on her behalf; made an appointment to see me the next day (5/7/19). By that time not only were the hives on my arm and around the injection site, pain and redness was from my left shoulder down my upper arm. I felt dizzy all weekend and stayed close to the bed. As soon as Dr. saw my arm he ordered the medication, doxycycline monohydrate 100mg to be taken for seven (7) days along with an antihistamine (Zyrtec) 10mcg for the allergic reaction.
Patient was given expired Covid vaccine on 4/3/2023. This health facility was notified that the expired vaccine was given on 6/20/2023. Pfizer and the Health State Department were both notified. Pfizer advised that the vaccine was still fine and should not result in any adverse outcomes since it was given within a 7 day expiration window. This facility did attempt to contact the patient to let them know that an expired Covid vaccine was given in April but this facility has been unable to reach the patient. No adverse reactions have been reported. This health facility will complete continuing education for nurses to double check expiration dates on vaccines.
I developed a big red, round almost rash looking  spot right above my elbow on my left arm. Same arm that I received my vaccine on. I developed it yesterday, exactly 7 days after receiving the vaccine. It is warm to the touch and a little itchy.
Initial information and live follow up regarding this unsolicited case from a Pharmacist and transmitted to Sanofi on 19-Oct-2018. This case involves a 28 year female patient who experienced Breathing difficult, redness, swelling and unevaluable event after starting ADMELOG with the use of medical device SOLOSTAR and FLUBLOK QIV. Relevant medical history and Concomitant medication were not reported. On an unknown date, the patient started therapy with Insulin Lispro Solution for injection of unknown dose and frequency via unknown route with the use of medical device SOLOSTAR (Batch number: unknown, Expiration date: unknown) for unknown indication and on 17-Oct-2018 patient took quadrivalent recombinant influenza vaccine at a dose of 0.5 daily (unit unknown) (batch number QFAA1810) via Intramuscular route in right arm. On an unknown date, latency unknown after the initiation of Insulin Lispro therapy with the use of medical device SOLOSTAR and FLUBLOK, the patient reported that she was having trouble breathing. It was also reported that the patient was going to discuss with her physician about possibly switching to HUMALOG. On an unknown date in October 2018 patient experienced redness, swelling and redness spreaded on upper arm. Action taken was unknown with ADMELOG and not applicable for quadrivalent recombinant influenza vaccine. Corrective treatment unknown. Outcome of the event was unknown for Breathing difficult and recovering for rest events. No further relevant information was reported. Additional information received on 03-Jan-2019. Patient age, height, weight, date of birth, quadrivalent recombinant influenza vaccine, redness, swelling and redness spreaded on upper arm added. Narrative and corresponding fields were updated accordingly.
Months after receiving my vaccine, I went to the doctor for a normal appointment, but my blood pressure since vaccination has been slightly elevated during my last frequent visits which shocked my physician. It has been reading 166/120 lately since being informed to monitor it. My doctor short-term prescribed me Valsartan to help regulate my blood pressure. The medication has helped reduce my blood pressure, but at times, it is still slightly elevated. Recently, I've had an echocardiogram and CBC ran on me to see if anything significant would appear; but nothing conclusive or significant had arisen.
unk type of react, but rumored to have been adm to hosp w/poss stroke; only info available was that condition was better than noc of admission;
No adverse effect reported; patient received improperly stored VARIVAX; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Information about pertinent medical history, drug reactions or allergies was not provided.         On 30-AUG-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S005078, expiration date 19-FEB-2021, or lot # R019237, expiration date 04-JUL-2020, route of administration was not provided) for prophylaxis. The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent.  Administered doses of vaccine experienced temperature excursion of -9.74 degrees Centigrade (C) for unknown time. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
No adverse events to date. Patient was vaccinated with GARDASIL #1, LAIV, ADICEL, VARIVAX #2 on 10/7/09 after completing screening questionnaire that she is not pregnant. On 10/23/09 we were notified she is approximately 4 months pregnant.
JEV given on 4/11/06, past two days after receiving shot c/o headaches, abd discomfort, chills, change in taste "sweet", change in smell "fishy". 4/14/06 getting better today. F/U appt with MD on 4/19/06
sore throat; headache/headaches are debilitating 2 to 3 times per week/headaches each day; ringing in both of her ears/ringing more pronounced in her right ear; fever; mild muscle pain in her left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), HEADACHE (headache/headaches are debilitating 2 to 3 times per week/headaches each day) and TINNITUS (ringing in both of her ears/ringing more pronounced in her right ear) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced VACCINATION SITE PAIN (mild muscle pain in her left injection site arm). On 24-May-2021, the patient experienced HEADACHE (headache/headaches are debilitating 2 to 3 times per week/headaches each day) (seriousness criterion medically significant), TINNITUS (ringing in both of her ears/ringing more pronounced in her right ear) (seriousness criterion medically significant) and PYREXIA (fever). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat) (seriousness criterion medically significant). At the time of the report, OROPHARYNGEAL PAIN (sore throat), HEADACHE (headache/headaches are debilitating 2 to 3 times per week/headaches each day), TINNITUS (ringing in both of her ears/ringing more pronounced in her right ear), PYREXIA (fever) and VACCINATION SITE PAIN (mild muscle pain in her left injection site arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: showed nothing wrong (normal) showed nothing wrong.         Steroids , antibiotics used as treatment medications.   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.   This case was linked to MOD-2021-273428 (Patient Link).; Sender's Comments: 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.
Fever 24 hours after vaccine pinpoint non blanching petechral rash on trunk 3 days after vaccine, oral vesicles appeared 3 days later.
Freezing, muscle aches, sharp pain throughout the body and feet, bp 175/78, fever 100.9, Nauseous, headache, fever is 96.8 now Patient took tylenol 3:30pm on 3/22/21 and 7pm and then on 5:30am on 3/23/21
After the 1st dose of vaccine on the 3rd of July 2021, I have developed loss of hearing on the 4th of July and tinnitus. Went to see GP after the next 3 days as I thought it will recover by itself but it lasted until my second dose of vaccine on the 31/7/21. I had a loss of hearing again and numbness on the outer ear on the 1/8/21 and my tinnitus condition got worse. Next Tuesday I will go and refer to the ENT specialist for further check up
40 hours of side effects: Sore left arm, overall woozy feeling, headache, low grade fever for 24 hours between 99 and 100.6, chills, sweating, fatigue, weakness, shortness of breath, difficulty sleeping, (frequent urination overnight - more than 2 dozen trips to the bathroom with a full bladder on the first night), and moderate pressure/mild pain in heart.
Patient became unresponsive, stiffened up, and stopped breathing. After a minute patient came to. Called 911. Blood pressure, HR, and blood glucose was checked everything normal.