chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client came in prior to scheduled 2nd dose date. Nurse and Clerk believed today's date was 05/28/21 but later realized today's date was in fact 05/21/2021. Client was vaccinated ahead of schedule (minimum 3 weeks). On site MD was made aware. Team Lead and Site Manager were also notified. Client did not exhibit any side effects at vaccination table. He also did not diplay ny side effects in 15 min observation area. Client exited observsation area in stable condition.
Patient had an adverse reaction to the Afluria vaccine:  patient retuned about 15 minutes after administration and reported tinging down right arm that dissipated quickly.  The vaccine was administered correctly and per protocol/prescription.
swelling of arm, sore & stiffness traveled up to neck & shoulder;T101, nausea;
One week after the injection the site got hard with a red itchy rash .  I am using ice and cortisone cream to treat it. It has been 2 days at this point with no change.
Expired dose received on 29Jul2021, Vaccine syringe was given chance to warm up; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose received on 29Jul2021, Vaccine syringe was given chance to warm up) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose received on 29Jul2021, Vaccine syringe was given chance to warm up). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose received on 29Jul2021, Vaccine syringe was given chance to warm up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The HCP received the shipment of Moderna multi-dose vials on 22Jul2021 and stated that her team was new to the multi-dose vials and stated that 3 doses were administered to the patients after vaccine vial was expired and this was the first time this occurred and did not have any such previous incidences.   Storage condition before administration: Fridge  Taken out of Fridge drawn up and put back, syringe was given chance to warm up a bit while waiting on the patients and there were no visual changes of vaccine. And there was one vial that was impacted.  Refrigerated expiration date was 22-Aug-2021 and vial placed into fridge from freezer was 22-Jul-2021 however desired use by date within 24 hours of opening.  Max temperature: 41 degrees Fahrenheit with average temperature of 39.8 degrees Fahrenheit, Minimum: 38.6 degrees Fahrenheit. These were all temperatures of the fridge in Fahrenheit.   4 doses were administered from the vial.  Date vial was punctured: 28Jul2021  Total of 3 doses were administered after the vial was expired.   Unable to provide patient identifiers information and additional information about the patients but stated that total of 3 patients were affected after being given 3 doses from same vial after it was expired. These were 1st doses of Moderna vaccine for all 3 patients.   The caller stated that 2 of the patients were husband and wife who received the expired vaccine.
Dizzines and shortness of breath. Patient with steroid allergy and product hipersensitivity had epinephrine for the treatment of any event of allergy and she administered it for the treatment of the vaccine adverse reaction. None history of vaccine adverse event.
Information has been received from a nurse concerning a 4 year old male who on 08May03 was vaccinated with measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Concomitant therapy included diphtheria toxoid (+) pertussis acellular 3 component vaccine (+) tetanus toxoid (INFANRIX) and poliovirus vaccine inactivated (IPOL). Two days later on 10May03, the pt developed injection site reaction with redness, swelling and pain at the injection site. The pt was seen at the ER. Subsequently the events resolved. No further information is available.
Seen 11/14 for 1 day history of evolving well demarcated rash  with initial Dx it multiforme. Received 2 days later revealed rash that was changing in location . Not hives. No new skin. Antibac PO intake. No fever. Not ill.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 30 year old male of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: dairy allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 01 total administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 29 years old. No concomitant medications were reported.  On an unspecified date in MAY-2022, the patient tested positive for Covid (confirmed covid-19 infection which led to confirmed clinical vaccination failure). Laboratory data included: COVID-19 virus test Positive. On 16-MAY-2022, he started Paxloid shortly after testing positive for COVID and took last dose on 20-MAY-2022. After about a week, he tested negative and his symptoms had nearly fully subsided. Laboratory data included: COVID-19 virus test Negative.  After about 2 weeks since getting COVID, he started testing positive again and remained positive. Laboratory data (dates unspecified) included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20220610317-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
caught a cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (caught a cold) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced NASOPHARYNGITIS (caught a cold). At the time of the report, NASOPHARYNGITIS (caught a cold) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded. However, cold weather may have been contributory.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded. However, cold weather may have been contributory.
Patient is 12 years old and received the 5-11 age dose for the COVID vaccine.  The patient did not experience an adverse reaction.
An expired dose was administered; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (An expired dose was administered) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (An expired dose was administered). On 21-Jul-2021, EXPIRED PRODUCT ADMINISTERED (An expired dose was administered) 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 relevant concomitant medications were reported. Treatment medication was not provided by the reporter  The vial was moved to the refrigerator on 18/Jun/2021 and did not undergo any temperature excursion. According to refrigerator conditions, the vial expired on 18/Jul/2021.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: primary reporter  demographics was updated. patient race and Ethnicity was updated Dose 1 info body site.was added
Patient was administered a Covid - 19 Pfizer booster vaccine instead of an influenza vaccine. Patient already received primary series ( 2 doses) plus booster. This vaccination would be dose # 4 No adverse events reported
Immediately after MMR#2 given - small welt above injection site - about size of dime. Within 20 mins or less area about 2" around reddened. Only dime area raised. Encouraged BENADRYL which client took before left office. Marked redness area so client could keep eye on it - is physician. Checked on client at 4:45pm - as soon as home welt & redness gone - fine.
Diagnosed with Type 1 diabetes on 9/3/09.  10/16/09 Medical Records received for Dates of Service 5/17/07-10/2/09.  Dx: New onset Type 1 diabetes mellitus. Assessment:  Seen by PCP for well child visit.  Routine urinalysis revealed urine glucose of 2000+.  Denies frequent urination, no weight loss, pt. does "drink all the time," c/o being thirsty a lot.  Levemir 5 units given in office.  Referral made to endocrinologist.
Patient states that he got dizzy and fell off exam bed. Patient can't recall if he lost consciousness. No injuries noted, patient denied pain. Dr. examined patient prior leaving clinic.
NUMBNESS AND PARESTHESIAS OF EXTREMITIES LASTING SEVERAL DAYS, SEVERE HEADACHES LASTING SEVERAL DAYS, TINNITUS, DIZZINESS LASTING SEVERAL DAYS.   WITHIN 1 HOUR, HAD SEVERE DIFFICULTY BREATHING/SWALLOWING WHIHC IMPRIVED AFTER USING IHLAED EPINEPHRINE AT HOME.
Trouble breathing/SOB and pain day after vaccine, lasting two weeks. Heart palpitations and racing heart beginning appt a week after admin, activity intolerance r/t not being able to catch my breath lasting over a year.
Inadvertently gave MMR.  Pt was here to get Varicella as she had a titer drawn and showed low immunity and works in the health care field. However inadvertently gave MMR. Did give varicella at this time.
Patient tested positive for Covid-19 on 01/16/2022 and was treated for Covid-19 at Medical Center.  He was admitted for weakness, respiratory failure d/t Covid PNA.  He was treated with remdesivir and steroids and improved and then was placed Health Center for Rehab and Healing for PT and OT.  Patient expired on 02/09/2022.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Nov2022 as dose 5 (booster), single (Lot number: GL0446) at the age of 66 years, in left arm 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "OSA" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing); "Known allergies: PCN" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, COVID-19.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Information has been received from a nurse practicioner concerning an 8 yo female with no medical history and no allergies who on 05Apr1997 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live. The pt had otitis media at the time of vaccination but was afebrile. Concomitant medication included amoxicillin (+) clavulanate (AUGMENTIN) for "otitis media at the time of visit". It was noted that the pt "broke out in chickenpox post vaccination" with varicella virus vaccine live. On 18May2003 (previously reported as 19May2003) the pt presented to the office with a rash that was reported as varicella with about 20 lesions on her chest, arms, and back and had a fever of 103.2. Unspecified symptomatic treatment was required for the varicella as needed. No diagnostic tests were performed. Subsequently, the pt recovered. There was no product quality complaint involved. No further information is expected.
approx 28hr p/vax pronounced chills & shivering of hands last about two hours
Pt required COVID testing prior to surgery, tested positive 5/18.  Was asymptomatic for COVID
This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 06-MAR-2014, the patient was vaccinated with an improperly stored dose of GARDASIL 5 mg/0.5 ml injection, lot # J013777, expiration date 11-AUG-2016 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to two separate temperature excursions (dates unspecified): one lasting for 220 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.111111111 degrees Celsius) and another lasting for 244 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (0.555555556 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Large amount of swelling, redness and heat at the injection site; Large amount of swelling at the injection site; Large amount of redness at the injection site, heat; Large amount of heat at the injection site; Initial information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a six year old patient who experienced large amount of swelling, redness and heat at the injection site (vaccination site inflammation), (vaccination site swelling), (vaccination site erythema) and (vaccination site warmth), while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious large amount of swelling, redness and heat at the injection site (vaccination site inflammation), (vaccination site swelling), (vaccination site erythema) and (vaccination site warmth), (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Details of laboratory data not reported.    Corrective treatment was recommended to ice the site, motrin, benedryl.   At the time of reporting, the outcome of events were reported as unknown.  There will be no information available on the batch number for this case.
Severe. Diarrhea, irritability, intestinal upset for 3.5 weeks.
Rash to trunk; has persisted from 05/11/12 through today's date; 06/22/2012.  Itchy, red rash over trunk.
This spontaneous report was received from a medical assistant regarding multiple unspecified patients with unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, unspecified patients were administered with improperly stored GARDASIL 9 lot# M036059, expiry date: 03-JUN-2019 for prophylaxis (dosing details not reported). Temperature was reported as 51.6 F and time frame was 2 hours 20 minutes. There was no previous temperature excursion. The call was due to data logger. No adverse effects were reported. No product quality complaint was involved. This is one of the several reports due to the same reporter. Additional information has been requested.
I had a period that lasted over 3 weeks, including hot flashes, random bleeding starting and stopping.  Also started a Retina detachment, and had vitrectomy on April 5.
Swelling in upper arm below injection site, severe muscle soreness (5 out of 10) in forearm. Pain lasted for approximately four days.
right side of tongue from midline, swollen approx. 3X size of left side. some difficulty swallowing, water. approx. 45-50 minutes after I woke with this, I noted a large sore area on the lateral left side of my tongue. Arrived at work 6:30am and noted I was speaking with a "lisp" and tongue was still the same, no changes noted. Very tired, no energy. Reported this to our employee health at 8:00 am when they opened. I then was offered a Claritin by a coworker. approximately 2 hours later the swelling and sore had completely subsided.
skin was blotchy red; skin was blotchy red, swollen and warm to the touch; skin was blotchy red, swollen and warm to the touch; This case was reported by a nurse via sales rep and described the occurrence of red blotches in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA63AA, expiry date unknown) for prophylaxis.   On 1st May 2020, the patient received the 1st dose of Bexsero. On 6th May 2020, 5 days after receiving Bexsero, the patient experienced red blotches, skin swelling and skin warm. On 7th May 2020, the outcome of the skin swelling and skin warm were recovered/resolved. On an unknown date, the outcome of the red blotches was not recovered/not resolved.   It was unknown if the reporter considered the red blotches, skin swelling and skin warm to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. On an unknown date on friday, the patient received vaccine. On Wednesday morning the patient experinced skin was blotchy red, swollen and warm to the touch, no fever. On Thursday morning patient woke up and the redness had gone down the patients arm a little further but was no longer swollen or warm.
Fatigue and "muscles feel heavy", headache all started 1/19 around 1940.
sharp pain in my back; pain / along my right rib cage.; full blown case of shingles / from my center back to my center front / shingles rash / might be a side effect; blisters; shingles rash; last six weeks /have been totally miserable.; I continue to experience pain; This case was reported by a consumer and described the occurrence of back pain in a 76-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax with an associated reaction of no adverse event (Received 6-7 years before reporting date).   On 4th May 2021, the patient received the 1st dose of Shingrix. On 6th May 2021, 2 days after receiving Shingrix, the patient experienced back pain, rib pain, shingles, blister, vesicular rash, feeling miserable and pain. On an unknown date, the outcome of the back pain, rib pain, vesicular rash, feeling miserable and pain were unknown and the outcome of the shingles and blister were recovered/resolved.   It was unknown if the reporter considered the back pain, rib pain, shingles, blister, vesicular rash, feeling miserable and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Zostavax 6-7 years before reporting date and did not have any reactions with it. The patient received the 1st dose Shingrix and 2 days after the vaccination patient experienced sharp pain in back along right rib cage.  On Saturday the patient had had a full blown case of shingles, running from center back to center front. It was stated that the patient also had shingles rash and blisters. The patient stated that he/she got late in getting doctor involved because patient didn't recognize what was happening, but patient had been taking medications for the past six weeks. The patient wanted to report that but patient was told that he/she could not et shingles from Shingrix because it was a dead vaccine. The patient did not believe that contracting shingles within 2 days of receiving the Shingrix vaccine was a coincidence and patient was truly afraid of taking the 2nd dose, because the last six weeks of patient's life had been totally miserable. It was stated that the shingles rash and blisters were healed but patient was continue to experience pain from the area involved. The patient stated that he/she was in excellent health, except for that outbreak of shingles. The patient believed that the manufacturers of Shingrix should include as a side effect possible cases of shingles as a result of taking the vaccine. The patient might have done a better job with early identification of his/her problem had patient know that shingles might be a side effect.
This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 2-week-old female patient who received BOOSTRIX (batch number 7535X, expiry date 15th February 2015). On 6th January 2015, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. Additional information received: BOOSTRIX was maladministered to a 2 weeks old infant instead of Hepatitis B vaccine.
Developed hives within 15 minutes of receiving vaccinations. Gave 0.1 epinephrine IM in office.