chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 9:48 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021, 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.   The age of patient was provided as 32.39.  Concomitant products were not provided. On 07-jan-2021, Excursion time was 09 AM and 10 AM, with temperature as 34, and 34 respectively. Total doses given for the day was 96 for 9AM vials. Condition of vaccine prior to administration was not frozen. 9 AM and 10AM vaccine was moved to fridge on 05-Jan-2021 and. Vial was moved to clinic on 07-jan-2021. 6 vials from 9 AM and 10 AM were sent to clinic. Vaccine BUD date was 27-jan-2021 for 9AM,10 AM respectively. On 07-jan-202 no hourly temperature recordings available The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was 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 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Seasonal flu vaccine given in Right deltoid - patient complained later of pain in her upper arm (R) on same day - still says painfull 1/10/10. I told patient to take Tylenol (not helping)
pt recv vax 24JAN98 & on 9FEB98 pt exp a breakthrough of chickenpox;@ the time of report the fever had resolved & sx were decreasing;
PATIENT FAINTED IMMEDIATELY AFTER INJECTION OF GARDASIL. 5 SEC. OF COMPLETE UNCONSCIOUSNESS FOLLOWED BY CONFUSION, DIZZINESS AND NAUSEA UPON AWAKING.  PATIENT MONITORED FOR ADDITIONAL 15MIN AFTER INJECTIONS WITH VITAL SIGNS AND COMFORT MEASURES.
Pt was administered H1N1 flu vaccine intranasal instead of intramuscular, no symptoms of flu is noted of 12/16/09. Thinking that this is protocol no MD order in place
1 day after COVID shot #1, she experienced vomiting lasting 18 hours with spontaneous resolution.  She notified V-SAFE and was directed to get COVID-19 testing - result negative.
low grade fever; facial rash; generalized maculopapular rash; facial rash; This spontaneous report was received from a company representative and refers to a 1-year-old male patient. The patient had no medical history or previous drug reactions or allergies. No information regarding the patient's concurrent conditions or concomitant medications and was reported.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), hepatitis a virus vaccine inactivated (HAVRIX) and an unspecified influenza virus vaccine (strength, dose, route of administration, lot number and expiration date were not provided) for prophylaxis.  On an unknown date, 2 days after the vaccinations, the patient experienced low grade fever and a facial rash. The patient recover from these events on an unknown date. Then, on an unknown date, (reported as about 12 days after vaccinations), the patient experienced generalized maculo-papular rash that lasted for 2 to 3 days. On an unknown date, the patient experienced another facial rash, which was treated with hydrocortisone cream. The patient sought medical attention. No laboratory studies or diagnostics were performed. On an unknown dates, the patient recovered from the events.   The causality assessment between the events and the suspect therapies was not provided.
Eleven months after first dose of COVID 19 vaccine, she also had second dose and booster, patient was diagnosed with pancreatic cancer.  Her sister was diagnosed with breast cancer 8 months after she had her first dose of COVID 19 vaccine.  Both are BRCA 2 pathogenic mutation positive.  Patient died on Aug. 1, 2022.
Syncope, mild tremors, vomiting, nausea, headache, lethargy.
Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from other health care professional. This case involves a patient (age and gender was not reported) who received vaccine PENTACEL expired on 29-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (expiry date: 29-Oct-2018, lot number, dose, dose in series, route and site of administration was not reported). It was a case of actual medication error due to expired vaccine used. It was unknown if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Menveo administered to a 57 y/o; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 57-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMA749A, expiry date 30th November 2023) and (batch number AMXA749A, expiry date 31st March 2024) for prophylaxis.   On 29th September 2022, the patient received Menveo. On an unknown date, the dose was an unknown dose. On 29th September 2022, unknown after receiving Menveo, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 29-SEP-2022 Reporter's Comments: The pharmacist asked for information about the administration of Menveo to a 57 years old patient. Since Menveo was approved for use in patients until 55 years old, she was asking how to proceed with this patient.  The reporter was consented to follow up. Additional Supportive Information: Menveo vaccine was administered to a 57 years old patient, which led Inappropriate age at vaccine administration.
Chest pain and discomfort in center of sternum area, low grade fever, aches began 12 hours after 2nd dose of vaccine, lasted approximately 24 hours. Took Tylenol which helped. No reactions during 1st vaccination dose.
Patient called the pharmacy the day after receiving her 2nd booster COVID-19 vaccine with complaints of new onset lip swelling. Upon questioning, patient stated she has lip fillers. Patient instructed to use Benadryl; let the pharmacy know if she wasn't seeing any improvement and possibly reach-out to her doctor. Two days after the vaccine, pharmacy called patient to check-in on her. She stated the swelling has gone down, but still having a little bit of swelling and continues to use Benadryl.
Fever 103.5 rectally 5 hours after vaccine. Cranky 102.1 hour after Tylenol. 99.0 8 hours after initial reaction.
4-30-2021  Patient reported he has had  uncomfortable, burning sensation right upper arm  since administered 1/27/2020 Symptoms are persistent and unchanged but not disabling.
Did not feel well and began to have lower back pain and dry cough by 10/22/2015 could not walk or lie down, pain became debilitating and can not put arms and hands together or up to my face or behind my back.
Information has been received from a medical assistant concerning a 45 year old male with a history of lung disorder unspecified who on 20-DEC-2006 was vaccinated with Pneumovax 23 (lot # 655499/0988F).  No concomitant therapy was reported.  On 21-DEC-2006, the patient sought medical attention and presented back to the office with fever and an injection site reaction which was sore, red, and swollen.  On an unspecified date, the patient recovered from fever and injection site reaction (sore, red, and swollen).  No further information was available at the time of reporting.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released by the regulatory agency.  Additional information has been requested.
Received partial dose; Syringe leakage; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Received partial dose) and SYRINGE ISSUE (Syringe leakage) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Received partial dose) and SYRINGE ISSUE (Syringe leakage). At the time of the report, INCORRECT DOSE ADMINISTERED (Received partial dose) and SYRINGE ISSUE (Syringe leakage) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
patient came in to pharmacy 2 days after shot administered.  had redness and bruise at injection site.  reported the evening of receiving the shot felt very ill and vomitted.  advised patient to contact dr to report, could use cold pak, tylenol.
Vaccine leaked from syringe while patient was receiving the shot, more than half to 3 quarters of vaccine was administered; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Vaccine leaked from syringe while patient was receiving the shot, more than half to 3 quarters of vaccine was administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (Vaccine leaked from syringe while patient was receiving the shot, more than half to 3 quarters of vaccine was administered). At the time of the report, UNDERDOSE (Vaccine leaked from syringe while patient was receiving the shot, more than half to 3 quarters of vaccine 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.
About 30 minutes after shot started having the sensation of swimmers ear(only in left ear/shot was given in left arm. This continued for a couple hours and then started having ringing in both ears(gradually increased in loudness and then that nite abt 530 increased to loud chirping).Has not stopped so far. Know it?s not adverse but side effect of shot. Hopefully will subside.
After both doses, I could not sleep well the night after. I had no other adverse reactions, other that a sore arm.
Severe Migraine since vaccine on 05/28/2021.  Several treatments tried.  Nothing helped until Botox and gabapentin--which just masks the migraine.  The migraine is still there.  I have had many trips to urgent care for relief.  Steriod infusions help at urgent care when my pain gets to a 10.  I have been to a neurologist for Botox twice now and they don't know if my migraine will ever go away completely.
Hospitalized 3/24/2021 to 4/7/2021. Death 4/7/2021. From Records COD = SEPTIC SHOCK, COVID - 19. place of death: HOSPITAL-INPATIENT; certified by: PRONOUNCING AND CERTIFYING PHYSICIAN; occupation: HOMEMAKER, NONE
pt recv vax;2 days later, arm very red hot to touch, tender; extended almost to elbow; 17apr still red over much of upper arm,very tender when working on computer;
Chest pains- 8 hours after administration for little less than 48 hours; in addition to migraines, extreme fatigue, shortness of breath and sensitive to light.
This spontaneous report was received from a Registered nurse regarding a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 06-AUG-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
pt recvd vax;woke up from nap crying non stop (almost) for 5 mins at a time nursing; pt cried for 12 hrs; no sleeping; no fever; no redness; MD notified; no tx; give DT comp series;
upper part of the arm constantly hurting; arm still trembling; 2x4 inch area around bandage and injection site was really red; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-May-2021 and was forwarded to Moderna on 04-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (upper part of the arm constantly hurting), TREMOR (arm still trembling) and VACCINATION SITE ERYTHEMA (2x4 inch area around bandage and injection site was really red) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 029L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Blood pressure and Cholesterol.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (upper part of the arm constantly hurting), TREMOR (arm still trembling) and VACCINATION SITE ERYTHEMA (2x4 inch area around bandage and injection site was really red). The patient was treated with CARBIDOPA MONOHYDRATE, LEVODOPA (SINEMET) for Trembling, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (upper part of the arm constantly hurting), TREMOR (arm still trembling) and VACCINATION SITE ERYTHEMA (2x4 inch area around bandage and injection site was really red) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products included blood pressure pills and cholesterol medications   This case was linked to MOD-2021-103033 (Patient Link).
Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In JUN-2019, the patient received Shingrix. In MAY-2022, more than 2 years after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK receipt date: 23-MAR-2023 The case  was received from the patient via  interactive digital media. The patient got shingles in early May 2022. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
skin erythema and warm to touch  - adecel over right deltoid on 7/30 - developed erthema today morning, slightly larger over time - 8x8 cm area of induration - warm to touch - no fevers or chills - mild pain to touch - no fluctuance - no reaction after shot.
Moderna COVID-19 Vaccine EUA Patient reported generalized pruritic rash upon waking up the morning of 12/27/20, also reports "scratchy/itchy" throat.  Patient with stable vital signs, speaking in full sentences and hives over bilateral upper extremities and chest, examined at 815am.  Patient given 20mg dexamethasone IM, zyrtec 10mg and sent home to take 50mg oral benadryl.
My arm began to feel swollen and when I looked at my arm it had a large area of redness that extended about 4 inches from the injection site. My arm was warm, swollen, and itched.
URI symptoms of cough and runny nose.  TMax: 104 relieved with Tylenol 2.5 milliliters. Fever returns in 4-5 hours.
I experienced had recurrent headaches 04-02-2021 lasting to 04-22-2021.  I did not work 04-02-2021, 04-03-2021, 04-04-2021 and also on 04-14-21 and 04-15-2021. I also had some nausea that came and went in the time I experienced the headaches.  n 04-08-2021 had a telehealth visits about my headaches and recommended I take two Benadryl tablets to break the cycle of the headaches and try it for 3 days. On 04-13-2021, went to urgent care, they gave me tramadol and more migraine medicine and I got sick for the next couple of days and could not hold any water or food. I also had a CT scan which did not demonstrate blood clots. I also had lab work performed.  I take Furenell which I take for my migraines.
This report refers to my Moderna booster vaccine. I have never had eustachian tube dysfunction or tinnitus until two weeks after the booster vaccine on 11/02/2021. I now have tinnitus and problems in my ears including sensitivity. My ears feel full and I can't pop them. They also feel like I'm talking underwater at times. The tinnitus ringing is extremely loud and never goes away, although sometimes it gets not as loud but it is always there. I also sometimes feel dizzy. My healthcare provider has checked me three different times for water in the ears, wax, etc. but there is nothing there. Everything looks fine. I've taken decongestants, nose spray and nothing seems to help. I continue to do these things to keep my sinuses as clear as possible. I also took a round of antibiotics in hopes that it was an ear infection but it did no good. They even put me on blood pressure medication because my blood pressure was slightly elevated. It has never been elevated in my life until now. Nothing has changed the situation with my ears.
After receiving the inactived Influenza vaccine at an employee free vaccine pop up, I could feel my heart pounding hard and faster then normal just as I left the parking lot. I was relax and not stressed.  Went to the ER 5 hrs after the vaccine to get checked,  and it was consistently high, a bit over 100, but they weren't too concerned and chalked it up to probably be caused by an energy drink I had 5 hrs before the vaccine.  Due to the fast heat rate continuing,  I went to my regular PCP on day 3, had blood work done that was normal.  This continued for for 4 full days before starting to slow down. No caffeine at all during the entire encounter.
Soon after vaccination patient felt very light headed. No Syncope. States always feels like this with needles.
SOB an felt funny after flu shot. C/O feeling cold, stridor wheezing R 24/mm, sinus tachycardia, numbness & tingling in fingers. Pulse 100-120, BP 140/90 to 165/90. Pt treated with epinephrine, benadryl, o2.
Patient was a normal 4 month old, no problems during birth.  One week after his 4 month shots, he had his first known seizure.  He continues to have seizures and also developmental delays. 3/20/08-records received-seizure on 11/18/04,  observed moving arms and legs,  in choppy motion, unusual breathing pattern and eyes deviated to left-C/O 2 days of congestion, non productive cough and fever. Routine office visits with no complaints until 6/16/05 C/O ear pain and fussy. Neurology consult 3/19/05-for seizure activity which have been decreasing in frequency. Normal neurologic exam. Follow-up: lack of balance, speech delays.
Pain soreness began the day after the shot and continued for a few days; tolerable discomfort & expected today, nearly 2 weeks later, itching, redness, swelling in area on arm near shot.
I?m currently pregnant and due August 1st.  After I got the tetanus shot on May 14th I?ve had chills, no appetite, nausea, diarrhea, severe headache, cold sweats, and now vomiting.
patient received the vaccine prior to be 5 years of age and is therefore ineligible to receive the vaccine.
Rash started on left breast for a few days.  Then, in 3 more days, other rash areas, looking slightly different were seen on lower abdomen, under right breast, right upper hip, between breasts and up to neck and on neck in a few spots.  Had other rash areas on left forearm, upper legs, and inside right ankle.
rash everywhere except face;vomiting & diarrhea;T103.9 @ one point;rash still visible 31MAR;wt loss of 2# w/in a wk;
1wk p/vax devel moderate fever followed by morbiliform eruption;no kopllllllllllllllllllllias seen;no conjunctivitis;no target lesions;