chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 26-MAR-2015, the patient was vaccinated with a dose of VAQTA (lot # K007827) 0.5 ml (expiration date, route and site of administration were not reported) that underwent temperature excursion. No adverse effects had bee observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient states that vaccine administration site became red, inflamed, "hard", and incredibly sore. She states it resolved on its own.
Arm was swollen and red, lymph area underarm swollen as well.  Per pt, dr is treating as cellulitis?
Mild dizziness began on day 2-3 (April 5-6 2021) following first dose of Pfizer Covid 19 vaccine .  Treatment with antihistamines for several weeks did not improve the symptoms.  Second Pfizer vaccine was given on April 24 at same location and time.  Severe dizziness began on April 26 and has continued since.  Treatments given by a vestibular physical therapist are minimally helpful and often do not indicate that the dizziness is exclusively positional (BPPV).  Dizziness is felt at complete stillness rather than with specific motions.   Exam by physician concluded that there is a component of vestibular neuritis that was not present prior to the vaccines.
pt vaxed on 26OCT92 & w/in 24 hrs pt devel blisters @ inject site; pt is afebrile; seen in office o 28OCT; tx included topicort gel;
Patient came into the Pharmacy 04/13/23 with a swollen upper arm @ injection site and stated that the area has been hot since she received the vaccine.  She stated she had been taking Tylenol but her arm still felt hot.  Advised pt to also take Benadryl.
This spontaneous report as received from a healthcare worker refers to a 4 month old patient of unknown gender. Concurrent conditions and medical history were not reported. On 25-JUN-2015, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # K015816 and expiration date 29-MAR-2016 (dose was not provided). This is one of several reports from the same source. Additional information has been requested.
Pt was nervous prior to vaccination.  Immediately after vaccination, pt experienced syncope.  VSS.  Pt able to be discharged w/ parent after 15 in wait.
First week following = flu type symptoms Next week rash & blisters all over face; gradually turned into painful swollen dark red face - itchy, painful Got worse each week:(    Finally diagnosed with Hashimoto disease from all this!!!   Still struggling with the Hashimoto disease, trying to control it
Tested positive after receiving 4 doses of the Pfizer Covid vaccines; Tested positive after receiving 4 doses of the Pfizer Covid vaccines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old female patient received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EL1283), on 26Feb2021 as dose 2, single (Lot number: EN6202), on 22Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 16Jun2022 as dose 4 (booster), single (Lot number: 9992VM) at the age of 81 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Tested positive after receiving 4 doses of the Pfizer Covid vaccines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
INCREASED SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disorder, occasional social alcohol user, smoker, and shortness of breath, and other pre-existing medical conditions included the patient had no known allergies and no known drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, atorvastatin, budesonide/formoterol fumarate/glycopyrronium bromide, and hydrochlorothiazide/losartan potassium. On 14-MAY-2021, the subject experienced increased shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from increased shortness of breath. This report was non-serious.
Local pain injection site. Increasing local muscle pain next day. Pain moving up arm into deltoid and now shoulder and neck. Injection administration 11/2/2016. Reports redness over Rt perispinal area, ongoing discomfort "as if hurt neck". No limitation.
Shot was given in left shoulder only slight pinch. 3 days later started deep dull muscle and joint pain in biceps, tricep, and shoulder joint. Discomfort primarily at night. Comes and goes. Some nights keeps me from sleeping.
Chest pain, elevated heart rate, and exhaustion. Went to the ER and then also went to the cardiologist at local Clinic and was diagnosed with pericarditis through  echo. Was put on a treatment plan with medication  and no exercise.
DEATH; This spontaneous report received from a consumer via a company representative concerned 06 multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total, administered on 2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients experienced death. On 2021, the patients died from unknown cause of death. It was unknown whether an autopsy was performed or not. It was reported as "No problems yet. You have 2 to 5 years. It Killed my sister, 2 shots & double boosted. And I've had 6 of my young friends in the last year die after taking the jab. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20221259488.; Sender's Comments: V0-20221259495-Death. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Pt recvd DTP/MMR/OPV p/administration of DTP pt lost consciousness became limp; then became rigid having 2-3 jerks of arms & legs lasting approx 20 sec;
Chills, body aches, fevers x3, no appetite, got up and violently threw up three times and then proceeded to have numbness and tingling in my upper and lower extremities along with extreme chills. The numbness in my fingers made it hard for me to hold my phone.  It would radiate from one extremity to the other and it did this for about 30-45 mins before it stopped.
This spontaneous report as received from a pharmacy technician refers to a 14 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 13-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent condition, medical history and drug reactions/allergies were not reported. Concomitant therapies included sterile diluent. On 05-FEB-2018 the patient was vaccinated with one dose of improperly stored VARIVAX (lot # N023960, expiry date: 01-SEP-2019), (dose, frequency and route were not reported) for prophylaxis. It was reported that the VARIVAX was exposed to temperature of 6 degree Fahrenheit (F) to 14 F for 36 minutes. No adverse effects reported. Product quality complaint was not involved. There was no previous temperature excursion reported. The digital data logger was involved. Sender's Comments: US-009507513-1803USA003566: US-009507513-1803USA003698: US-009507513-1803USA003697: US-009507513-1803USA003696: US-009507513-1803USA003699: US-009507513-1803USA003695.
Cellulitis left thigh for 2 days.  Treated with warm compress, Cephalexin by mouth for 10 days.
this increasingly became worse; he noticed it more and thought it was was weird; a slight ringing in his ears; Little tired next day; Right arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 24Mar2021 12:00 (Lot number: ER8727, Expiration Date: 31Jul2021) at the age of 61 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Pfizer COVID vaccine 03 Mar 2021, Lot EN6205, Expiration 30 Jun 2021. 0.3ml dose. Injected in right arm in the muscle.), administration date: 03Mar2021, for Covid-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 26Mar2021 12:00, outcome "not recovered", described as "a slight ringing in his ears"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "this increasingly became worse"; FATIGUE (non-serious) with onset 25Mar2021 12:00, outcome "recovering", described as "Little tired next day"; PAIN IN EXTREMITY (non-serious) with onset 25Mar2021, outcome "recovering", described as "Right arm soreness"; FEELING ABNORMAL (non-serious) with onset 28Mar2021, outcome "unknown", described as "he noticed it more and thought it was was weird".  Additional information: Patient had second dose and 2 days later he had ringing in the ears and as the days went on this increasingly became worse. Right arm soreness at middle of night and early in the morning and then it went away. Patient went to see an audiologist and was calling to see what type of information Pfizer has regarding this. He knows it was not common. He did not have any ringing prior to having the second Pfizer COVID vaccine. If he would have known this would happen, he would not have gotten it. The patient stated that some days the ringing was in one or the other ear. Some days it was in both. On 28Mar2021 patient was noticed it more and thought it was weird. Some days it was worse than others. By Sunday after the vaccine, it was worse for ringing in ears. This all just came about from the vaccine. It may have been psychological for tiredness. He said it was not bad. He has not had a vaccine in 20 years or longer. No ER or physician's office required. He went to an audiologist on 30Mar2021. They just did a check up and no medication offered. He heard people got steroids, but he did not. Reporter seriousness for events were unspecified. The patient did not administered any other products. Prior Vaccinations patient was received 1st COVID vaccine within 4 weeks.   No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a nurse refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with his first dose of GARDASIL injection, dose (unknown) and route of administration (unknown), for unknown indication. The patients second dose of GARDASIL was administered a year later on an unspecified date. No adverse effect reported. No product quality complaint was involved. The outcome of events was unknown. No further information available. Additional information has been requested.
This spontaneous report was received from a registered nurse concerning an unknown number of patients who on on unknown dates might have received improperly stored ROTATEQ (dose and route not provided) (lot # 0059AE, expiration date on23-SEP-2013; lot # 1710AA, expiration date on 11-JUL-2013). The nurse sated that the vaccines were exposed to 47-48 F for 72 hours and 32 F for 24 hours. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected.
According to the parents, he had a red rash develop the day of the vaccination when at home. It went from his left arm I believe to the parts of this chest and other parts of the body over the next few days. The entire family had the same vaccination given but he is the only one that reacted to it later on at home.
Two weeks after first shot began having ringing in my ear.  Subsided a little, but after my second shot in my right arm, the ringing was worse and was in my right ear.  It's been two weeks and the ringing is still there.  I had a hearing a test and my hearing is perfect. I was put on a steriod for 5 days for possibly inflammation in my ear.
This spontaneous report as received from a Licensed Practical Nurse refers to a 15 months old male patient. On 31-OCT-2012 the patient was vaccinated with 0.5 ml of M-M-R II (Lot# reported as 0183, Exp date 18-JAN-2014, subcutaneous) that was exposed to 53F for 12 hours, due to hurricane Sandy. No adverse effects reported. No treatment information was reported. The outcome was unknown. Additional information has been requested.
Side Effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Side Effects) in a  patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Side Effects). At the time of the report, ADVERSE REACTION (Side Effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.   Reporter did not allow further contact
Fine until about 4 a.m. on the 20th, day after vaccine. Woke up with uncontrollable shaking, nausea and teeth chattering, cold and could not move my left arm .  Same arm as shot. I had a temperature of 101.2 Took tylenol, still sore and chills. Had to call in to work to   say I was sick. Took naps mostly throughout the day, fever still persisting around 101. Took Tylenol, 2 hours later fever down to 99.1.  Could not stay awake for long. Slept most of the day.
The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 06-Apr-2022; received a vaccine past the 30 day storage on the refrigerator.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 06-Apr-2022) and EXPIRED PRODUCT ADMINISTERED (received a vaccine past the 30 day storage on the refrigerator.) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (ASA), Allergic reaction to analgesics (Morphine) and Diabetes. Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), LORATADINE, TRIAMCINOLONE, LOVASTATIN, SALBUTAMOL (VENTOLIN [SALBUTAMOL]), FLUTICASONE PROPIONATE (FLOVENT), GLIMEPIRIDE, LISINOPRIL and METFORMIN for an unknown indication.    On 06-Apr-2022 at 9:07 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022 at 9:07 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a vaccine past the 30 day storage on the refrigerator.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 06-Apr-2022). At the time of the report, PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 06-Apr-2022) and EXPIRED PRODUCT ADMINISTERED (received a vaccine past the 30 day storage on the refrigerator.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was not COVID positive within last month.  On 25-Feb-2022 vial was initially stored in the refrigerator.  It was reported the patients were vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022   Vial did not undergo any temperature excursions  HCP confirmed that the patients were not experiencing any side effects yet.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2022: Follow-up received, report type changed (Invalid to Valid) spontaneous, reporter type updated, contact information added. Patient details, medical history, dosage details and concomitant medication added.
I developed dysautonomia (elevated heart rate, chest pain, and shortness of breath upon standing. also GI distress) on June 12, 2021. I ended up in the emergency room and being admitted to the hospital twice over the next week and a half. I have been trialing medications, wearing compression socks, and drinking a lot of water and eating a lot of salt. My symptoms have improved a little but my doctors believe I will be managing this for life (or at least a while).   Prior to this episode, I got the Janssen vaccine which caused me to have tachycardia for about 12 hours within the first 24 hours. I felt fine for a week but the second week I felt very fatigued and couldn't do much other than sit on the couch for the week.
MMRV (ProQuad) was reconstituted with Mantoux PPD instead of the supplied diluent.
Pregnant and received the Moderna COVID 19 vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received the Moderna COVID 19 vaccine) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 31-Dec-2020 and the estimated date of delivery was 07-Oct-2021. On 05-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received the Moderna COVID 19 vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  ninth week of the pregnancy.  On 05-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received the Moderna COVID 19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Amenorrhea for 133 days and irregular cycles.   History of 28-30 day cycles.  Menses occurred 10Apr2021.  Next cycle was due approximately 10May2021 and did not occur until 21Aug2021.  Cycle lasted 4 days.  Next cycle began 30Aug2021 and lasted 4 days.
Had a relapse  of nephrotic syndrome 3 days after the vaccine.  He is now back on steroids to put him back into remission after 4 years.
pt recvd 3 doses of Hep B vax during 1990 to 1991; pt failed to seroconvert & devel hepatic sx; no further details were provided;
Fever  Feeling tired Headache   Syndrome lasted for about 24 hours.  Treated with Tylenol and Ibuprofen
Breakthrough case admission after three vaccines Moderna 2/18/21 Lot# 015M20A;  Moderna 3/18/21 Lot# 010A21A;  Moderna 12/5/21 Lot# 045J2
Provided Hepatitis B Vaccine which was too early. Did not see birth dose. Should have been 6 months rather than 2 months.
Pt experienced athralgia, MD told pt his arthritis may be due to Lyme Vaccine. The pt also experienced lethargy. The lethargy and the now dx rheumatoid arthritis persists. Also states temperature as high as 101 degrees. The follow up received on 8/28/00 states, "pt never called our office with any adverse reactions so we have no date of onset."
pneumonia; Information has been received from a lawyer referring to a female patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 12-SEP-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient was diagnosed with pneumonia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event pneumonia was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the event pneumonia to be disability.   Upon internal review, pneumonia was determined to be medically significant.
Arm felt funny like medicine moving through it around 5:15PM-6:00PM. Hard to breathe around 6:30PM-7:30PM, Wheezing and coughing. Started to vomit from 10:30pm- 2:30 Am. Shakes and chills from 6:30 Pm. Still happening 12:49 pm 12-18-10.  I took a benadryl to help breath and it worked fairly quick but the other effects started. Still very shaky and I just don't feel normal
extreme chills, nausea, stomach cramps, extreme fatigue, severe arm pain ; 24 hour duration of events
Muscle cramps in hands and legs, severe pain, unable to walk, unable to move around. Went to doctor. Doctor has scheduled test, but currently no test have been done.