chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client presented at PH office requesting Flu vaccine - came with spouse. Reviewed screening questions - no contraindications. Received phone call at home from spouse at 630. Client had shaking episode and weakness/fever. Went to hospital admitted - had heart attack next day and deceased. Spouse received flu vaccine at same time as client with no adverse events. Same vaccine from same multi-dose vial. Client denied any allergies or problems with any previous vaccines. No egg allergies. He was admitted to the hospital. No confirmation received from attending physician that flu vaccine caused heart attack.
within a few minutes her face became flushed and she was dizzy. She was dizzy to the point she was not able to sit up. Dr gave her juice thinking it was her sugar level and that came back fine. Vitals came back all good. She was unable to sit up for over and hour. Dr then called the ambulance to come get her. She indicates she passed out in the ambulance on the way to the hospital. She was take to the hospital to be monitored. She has now had vertigo, headache and been nauseas since. She is unable to attend school as normal. Only time symptoms go away is with medication that puts her to sleep. She is unable to patriciate in sports as she is a gymnast.
56 adults patients received doses after its expiration date Jul 13, 2022; No Adverse Event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller mentioned that "the CDC had just approved extended expiration dates" and wanted to know if it was extended. When asked the caller stated that there were no remaining vials unused of that lot number and agent reminded the caller that no patients should receive doses from expired vials. Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case (1 of 56 patient)
Red rash on arm near vaccination site approx 1" x 2" in size. Just noticed today 2/17/2021 2 weeks after vaccination
Nontender, erythematous, indurated swelling Right thigh 5cm and 5cm around inj. sites noted within 24 hours of vaccin.
No adverse event; HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) in a 69-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7664B) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In August 2023, the patient experienced ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage).    Concomitant medications were not reported.  They accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage. No adverse event was reported for any of the patients.  Treatment medications were not reported.  This case contains information for patient 3 out of 25.   This case was linked to US-MODERNATX, INC.-MOD-2023-738766 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2023: Live significant follow-up received contains Patient age, initials, gender and new references added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738766:Patient 1 (Master Case)
1st evening after vaccination "I" started to feel small pain in the left part of "my" chest, "I" measured bpm by "my"  phone and it was 51. Next day evening "I" had medium pain in the mid left part of "my" chest and same 50-51 bpm.; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the right arm on 16Apr2021 at 16:15 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included lifitegrast (XIIDRA) eye drops for an unknown indication from an unknown date and unknown if ongoing. On 16Apr2021 at 21:00, 1st evening after vaccination, the patient started to felt small pain in the left part of the chest. Next day evening, the patient had medium pain in the mid left part of the chest with 50-51 bpm. It was reported that low blood pressure was normal for the patient and she had requested an appointment with her physician. On 16Apr2021, the patient underwent heart rate test by her phone and the result was 51 bpm and also underwent blood pressure test and the result was 114/70 on the left arm and 117/75 on the right arm. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event small pain in the left part of the chest and medium pain in the mid left part of chest was resolving at the time of this report.    No follow-up attempts are needed. No further information is expected.
3 days after injection of J&J Covid19 vaccine, I experienced heart palpitations for over 24 hours and went to the clinic for evaluation.  A week later I experienced chest pain and was inpatient at the  Hospital  for 2 days.  In patient, I had a variety of tests performed, including angioplasty where no blockage was found.  EKG showed minor issue with ventricular palpitation.  I almost fainted during my stress test, and tests showed low platelette count to check for CVST (I have family history of CVST).   I am to see a neurocardiologist on June 16th for further investigation.
I woke up the morning after the vaccine and was feeling very ill, and was experiencing symptoms of extreme fatigue and tinnitus, both which I am still experiencing five weeks later. The tinnitus is ongoing, as is the extreme fatigue. I have also been experiencing body and joint aches which continue five weeks later, and my Crohn's and Rheumatoid Arthritis are now flaring severely, only since taking the Covid vaccine. I had not had Crohn's symptoms for years prior to the Covid vaccine. I feel physically awful since taking the vaccine and have not been able to function each day at the same level that I was able to function prior to the vaccine. I am also afraid this tinnitus and fatigue will never go away.
Some kind of rash at the injection site with a bump in it; This spontaneous case was reported by a consumer and describes the occurrence of   in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M2DA) 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. The patient was treated with PARAFFIN SOFT (VASELINE [PARAFFIN SOFT]) at an unspecified dose and frequency.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
Welts on face about 4-5 hours later; red line under right arm; rash over body; hand and elbows swelled up; hand and elbows swelled up; face swollen; throat started feeling strange; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received BNT162B2 (Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 09Jul2021 16:15 (Batch/Lot Number: EW0196P, age at vaccination was 56-year-old) as dose 1, single for covid-19 immunisation. Patient was not pregnant at the time of vaccaination. Medical history included known allergies: Penicillin and sulfa drugs. Concomitant medications was not reported. The patient previously took Penicilin and Sulfa drugs. The patient had no other medical history. The patient was not tested for COVID prior vaccination. The patient had no other vaccine in four weeks. The patient had no other medications in two weeks. The patient had welts on face about 4-5 hours later. Took Antihistamine and they went down and in the AM not as bad. A few days later welts and a red line under right arm. A few days later a rash over body. The next day my hand and elbows swelled up. Took a bunch of antihistamine and it started to get better then another rash all over hands and face swollen, throat started feeling strange so she took a shot of epipen into her leg. It has been 2 days since that and the rash was subsiding. The second time, as per ED notes "adverse effect of vaccine". The events occurred on 09Jul2021 9:00 AM. The patient underwent lab tests and procedures which included Nasal Swab: negative on 15Jul2021 Nasal Swab. Therapeutic measures were taken as a result of welts on face about 4-5 hours later (urticaria), rash (rash). Outcome of rash was recovering and other events was unknown.
This spontaneous report as received from a nurse refers to a female patient (estimated age 11 years). There was no medical history or allergies. On 17-FEB-2014 and 18-APR-2014 the patient was vaccinated with GARDASIL dose 1 and 2. There was no concomitant medication. On an unknown date in 2014 after receiving a first and second dose of GARDASIL the patient developed pimples in her ears and on her arms and neck and was itchy all over. There was no treatment. The outcome of developed pimples in her ears and on her arms and neck and itchy all over was reported as not recovered/not resolved. The nurse inquired if this patient should receive the third dose. Additional information has been requested.
Vertigo/Nausea; Treatment at Emergency room; Treated with Meclizine and ondansetron
Mom states pt had bumps on body the next night after shots were given. Had hives on his legs up to the thighs, and some on arms and abdomen.  States there were "red dots" mainly on his stomach and back. Not on chest or face or arms where shots were given. Mom stated she applied baking soda paste.
A report received from health professional via medical rep concerning a 6 year old, female patient. Patient relevant history, concurrent diseases and concomitant drugs were not provided. Patient received FLUMIST quadrivalent vaccine. The outcome of nosebleed was unknown. The reporter assessed nosebleed to be non serious. Reporter and company physician considered the nosebleed to be unrelated with FLUMIST quadrivalent.
other severe and permanent health consequences; cardiovascular event; hearing difficulties; Information has been received from a lawyer regarding a case in litigation referring to a male patient (pt) of unknown age. The pt's concurrent conditions, medical history and concomitant medications were not reported. On 31-MAY-2009, the pt was inoculated (at 72 years (inconsistent information as it was reported as at 76 years)) at the pharmacy with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions. As a result of the inoculation, the pt suffered in or about 2009, a cardiovascular event (cardiovascular disorder) and hearing difficulties (deafness), including any, and all its sequelae; and was treated by a health care provider (HCP) for such conditions. As a result of the inoculation, the pt suffered severe personal injuries, pain, suffering, and emotional distress, as well as incurred substantial economic damages. As a direct and proximate result of the vaccine's alleged defect, the pt suffered severe and permanent physical injuries, including but not limited to a cardiovascular event and hearing difficulties, as well as other severe and permanent health consequences (ill-defined disorder). The pt endured substantial pain and suffering and incurred significant expenses for medical care and treatment and would continue to incur such expenses in the future. The pt has lost past earnings and suffered a loss of earning capacity. The pt suffered and would continue to suffer economic loss, and has otherwise been physically, emotionally and economically injured. The pt's injuries and damages were permanent and would continue into the future. The pt sought actual and punitive damages from the company as alleged herein.  The reporter considered cardiovascular disorder, deafness and ill-defined disorder to be disabling events.  Upon internal review, deafness was determined to be a medically significant event.
Swelling around left thumb and pain going up arm.  Patient is icing the hand and took Advil 1 day.
Fever, aching, chills within 4 hours. Fever and aching from 09/19/2020 through 09/22/2020. Severe swelling and mounding at injection site mimicking outbreak of shingles. Area hot and sore and itching involves an area 5? x 6? from front to back of stem and a towards shoulder. Painful and hot.
Hives. ER visit. Do not feel is related to shots but being cautious hydroxyzine. Patient has a rash of hives or urticaria. I suspect this may be an allergic reaction from his MMR or other vaccinations. Other possible causes could be a virus. Food or medicine. This is not the same I believe as an "MMR" reaction. Which usually occurs 7-10-14 days after an MMR. The rash in this instance is not hive like. And is a measle like rash. Moreover usually fever is a prominent component to this type of rash. This has not yet been the case with patient. ATARAX usually works better than BENADRYL and I would use it instead. He may have a dose every 6-8 hrs as need for the hive like rash. I would have him reevaluated by clinic on Monday. Return sooner to the ed if he worsens.
Hardened red warm to touch area of right deltoid 2 days after injection.  Area 6" x 6"
Pt recvd hep B vax on 19JAN88,16FEB88 & 16AUG88.Blood work on 14AUG90 showed pt not immune to Hep B. 2nd series of vax started;pt expects to complete those in MAY91.
Soreness under left armpit (where "I" got the shot); This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Mar2021 at 10:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies however, the patient had penicillin reaction as a kid. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included unspecified daily multivitamins from an unknown date and unknown if ongoing. On 03Mar2021, the patient experienced soreness under left armpit (where the patient got the shot), especially about today on 10Mar2021, about 9 days after the vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On 05Mar2021, the patient underwent nasal swab test for COVID-19 and the result was negative. The clinical outcome of the event soreness under left armpit (where "I" got the shot) was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe headache, foggy feeling - strange. Excruciating pain at injection site - whole arm was so very painful. Radiated into shoulder and neck, down arm. Headache is so bad.
devel rash on face 8AM 5AUG92 fine red rash spread from head to toes on anterior; DPH given po rash resolved 6AUG92;
my positive COVID-19 Test on 02Sep2021; my positive COVID-19 Test on 02Sep2021; Blood pressure: 100/52; I was very ill for more than two weeks; This is a spontaneous report from a contactable consumer (patient). A 63-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) at the age of 62 years old, on 16Mar2021 (Lot Number: EP6955) as dose 1, single and on 06Apr2021 (Lot Number: EP7533) as dose 2, single; both doses were received via an unspecified route of administration for COVID-19 immunization. Medical history included allergies to adhesive (specific reaction was rash which was red and itchy, unknown what type of tape). The patient's concomitant medications were not reported. The patient previously took cefdinir and experienced diarrhoea, metoclopramide and experienced shaky, naproxen and experienced itching, and sulfamethoxazole and trimethoprim and experienced rash. The patient also previously took methylprednisolone acetate 80 Mg/mL on 01Oct2019 and 23Jul2019, and dexamethasone sodium phosphate "4_Mg/mV" injection on 25Nov2009, 01Oct2019, 01Nov2013. Historical vaccine, all received for immunization, included the following: Zoster on 15Mar2012; ZOSTER RECOMB ADJUV on 01Oct2019 and 23Jul2019; and INFLUENZA on 22Oct2018 and 04Sep2009. It was reported that the patient had their first vaccine on 16Mar2021 and second on 06Apr2021 at a pharmacy. The patient provided their positive COVID-19 Test on 02Sep2021. They were surprised at the test result since they had been "fully vaccinated". They were very ill for more than two weeks on an unspecified date in 2021. The patient's oxygen saturation level was still only 95 % (2021). The patient wanted to inform that the vaccine did not work for them. The patient was seen on Thursday, 02Sep2021. The following issue was addressed: COVD-19 virus infection, and the following results were obtained: Blood pressure: 100/52, Pulse: 81, Temperature: 97.9 F, Oxygen Saturation: 98 %. POC RAPID STREP A for COVID-19 virus infection (Negative) and POC COVID-19 PCR DETECTION COVID-19 virus infection (Positive); both done on 02Sep2021. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
2/2 Headaches. 2/3 Swollen glands & sore throat. 2/6 Rash. 2/7 Joint pain. 2/16 All sx except for joint pain have resolved on own.
Date of  second vaccination was  03/15/2021,  At approximately the month of May, I began experiencing diminished senses of small and taste. I could detect strong odors, ,but had very little or no sense of taste.  I understood these might be early signs of Covid-19 infection, but I had tested negative for Covid-19  in July 2020, and again in July 2021.  I had a third "booster" injection of the Pfizer vaccine, lot FC3183, at my local supermarket pharmacy on 9/28/2021.  I have occasionally noted some senses of smell, but have had almost no improvement in sense of taste.
1wk p/vax rash to perineum, fever x 1 days;pt then c/o pain to knee;pain cont, knee became swollen;seen by MD;sed rate sl elevated;other blood work negative;advised by MD to see rheumatologist;
Left arm pain and muscle tightness. Unable to close left hand.; Left arm pain and muscle tightness. Unable to close left hand.; Left arm pain and muscle tightness. Unable to close left hand.; This is a spontaneous report received from a contactable consumer (patient)  A 36-year-old male patient received first dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Batch/Lot Number: EW0186) on 20Aug2021 at 16:00 , via an unspecified route of administration, in Arm Left as single dose for COVID-19 immunisation.   Medical history included dust allergy and mycotic allergy.     On 21Aug2021 at 04:00 p.m. the patient experienced left arm pain and muscle tightness,  unable to close left hand with outcome of not recovered.
Pt reports achy on Sat evening (body) 11/1/03. On 11/2 stiff neck (L) and back, left upper shoulder and arm, elbow pain, persisted 11/2-11/5, took Aleve and hot packs. Good movement, ROM better today. If not improved next week to contact MD.
mom called & stated that pt was vaxed 10JAN95 & had no problems but today 13JAN95 nursery called & told mom that pt was crying loudly-rt eye swollen & red blotches to face; pt was a little warm; mom told pt scratched cornea;
Crying, fever of 104. Fussiness. E.R. Tx - TYLENOL F/U with Dr.