chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a register nurse refers to a 1 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 31-JAN-2014, the patient was vaccinated with dose 1 of ROTATEQ lot #J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
platelets dropped to 3000; This spontaneous case was reported by a consumer and describes the occurrence of PLATELET COUNT DECREASED (platelets dropped to 3000) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (Patient takes "cancer medication"). Concomitant products included OSIMERTINIB MESILATE (TAGRISSO) and APIXABAN (ELIQUIS) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PLATELET COUNT DECREASED (platelets dropped to 3000) (seriousness criterion hospitalization prolonged). The patient was hospitalized from 15-Mar-2021 to 24-Mar-2021 due to PLATELET COUNT DECREASED. At the time of the report, PLATELET COUNT DECREASED (platelets dropped to 3000) outcome was unknown. Not Provided          Treatment of this event was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
I woke up with acute vertigo on Thursday. The room was spinning. I could not function from about 8:00 a.m. until about 6:00 p.m. I went to the doctor the next day, Friday, and was diagnosed with labyrinthitis due to allergies. I had no allergy symptoms. By Saturday, I was no longer dizzy but my ears felt full and continue to feel clogged 6 days after the onset of the vertigo.
On Friday Pm 23JUN had fever 101-102 gave APAP; still had fever on Saturday & cont giving APAP q 4 hr; about 2AM 25JUN had sz turned blue & stopped breathing; taken to ER
sick as hell; Initial information was received on 11-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer (patient) via social media.  This case involves a patient (unknown demography) who got sick as hell (illness), after the patient received INFLUENZA VACCINE.  Medical history, medical treatments, concomitant medications, vaccinations and family history were not provided.  On an unknown date in 1972, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date in 1972, the patient was sick (illness, non-serious event) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that patient never had one and flu since.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
This spontaneous report has been received from a healthcare worker (also reported as clinical manager) refers to a patient of unknown age and gender who on 27-NOV-2013 was vaccinated with a dose of ZOSTAVAX (strength, dose and route not reported, lot # J008802, expiration date: 19-OCT-2014), that had been improperly stored. The temperature during the excursion was unknown, as it was not monitored. No adverse effects were reported. This is one of the several reports received from the same reproter. Additional information has been requested.
Dizziness, Myalgia, Arthralgia, Fever,  chills Narrative:
Pt received PCV7 and DTaP on 08/31/2000. 3-4 hours after, the pt started wheezing, SOB, rapid HR, low grade fever. Episode lasted 2 days and the pt was taken to the physician on 09/03/2001. The pt was given inj. and use of inhaler. CXR done and blood work done with all normal results.
I was told by the hospital that I had no recourse, I worked as a nurse for 1 yr before all of this, volunteered as an instructor.
Sore bruised arm,  tiredness,  fever 101.9. Headaches.  Symptoms ended Saturday night around 8 pm
Pt recvd vax on 3JUN92 & w/in 1 hr pt c/o lightheadedness; lightheadedness persisted for 12 hrs; sx resolved; pt was seen by MD; exam was nl;
Muscles twitching; arm felt like bowling ball where injection given; Muscles sore/body aches; Tender [where injection given]; Extremely tired; Severe chills; Shaking uncontrollably; Profuse sweating; This spontaneous case was reported by a nurse and describes the occurrence of TREMOR (Shaking uncontrollably), HYPERHIDROSIS (Profuse sweating), MUSCLE TWITCHING (Muscles twitching), INJECTION SITE MASS (arm felt like bowling ball where injection given) and CHILLS (Severe chills) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy, Drug allergy (ACE Inhibitors), Hypertension and Depression. Concomitant products included AMLODIPINE for Hypertension, OMEPRAZOLE for an unknown indication.   On 29-Jan-2021 at 10:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021 at 3:00 AM, the patient experienced TREMOR (Shaking uncontrollably), HYPERHIDROSIS (Profuse sweating) and CHILLS (Severe chills). On 30-Jan-2021 at 7:00 AM, the patient experienced MUSCLE TWITCHING (Muscles twitching), INJECTION SITE MASS (arm felt like bowling ball where injection given), MYALGIA (Muscles sore/body aches), INJECTION SITE PAIN (Tender [where injection given]) and FATIGUE (Extremely tired). On 30-Jan-2021 at 7:00 AM, CHILLS (Severe chills) had resolved. At the time of the report, TREMOR (Shaking uncontrollably), HYPERHIDROSIS (Profuse sweating), MUSCLE TWITCHING (Muscles twitching), INJECTION SITE MASS (arm felt like bowling ball where injection given), MYALGIA (Muscles sore/body aches), INJECTION SITE PAIN (Tender [where injection given]) and FATIGUE (Extremely tired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
WORST FLU SYMPTOMS; REALLY SICK; FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced worst flu symptoms, really sick, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from worst flu symptoms, really sick, and fever. This report was non-serious. This case, from the same reporter is linked to 20210727891, 20210728165 and 20210661128.
Information has been received from a physician concerning an 18 week old patient who on 01-APR-2009 was vaccinated with the first PO dose of ROTATEQ.  No adverse symptoms were reported.  It is unknown if the patient sought medical attention.  Additional information has been requested.
This serious spontaneous case, initially received on 06-Feb-2018, was reported by other non-health professional and concerns a female patient of unspecified age. The patient's relevant medical history and relevant  concomitant medications were not reported. On 10-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5mg,  route of administration: intramuscular, anatomical location: left deltoid, batch number: 195210, expiry date: not reported). On 06-Feb-2018, after 4 months 27 days of vaccination, the patient had flu. The patient consulted doctor in the evening and was diagnosed with type A influenza virus [explicitly coded as vaccination failure].  On the same day, the patient was treated with TAMIFLU. At the time of this report, the outcome of the event-  flu was not reported.
Headache, pains, shivers, hot then cold, general feeling of malaise.Cannot get warm. Took Tylenol and it had minimal effect.
Severe headache, slight nausea, very sore arm, tiredness. Lasted through the day and evening
This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 22-JUN-2016, the patient was vaccinated with VAQTA (lot # L015460, expiry date: 20-JUL-2017) for prophylaxis (dose and route was not reported), which was stored improperly.
Nausea, no vomiting, muscle aches, lightheadedness, headache worsened. HA was similar as migraine but without usual triggers and lasted much longer - 3 days - not helped with medications. Did not interfere with sleep.
the first booster I got sick for two days but I got better quick very quickly; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), administration date: 18Jan2021, for COVID-19 immunization, reaction(s): "Sickness", "Blood pressure high", "shaking and trembling"; Bnt162b2 (Dose: 02), for COVID-19 immunization, reaction(s): "I didn't feel good". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "the first booster I got sick for two days but I got better quick very quickly".  Additional Information:Consumer stated, "Well but the safety report you know the first dose that I had the Pfizer I got really sick and I called the reaction line and I couldn't report because I thought ,I really thought that it might be the last time in my life I thought, my blood pressure went sky high. I didn't suffer with high blood pressure but my blood pressure went so high and I was shaking and trembling and it went on for about, well until about three days before the second dose and so  I went to the heart hospital and heart hospital they checked my heart out and I talked to several doctors they still said its best to get the vaccine(Further not clarified) and when I called Pfizer they said as long your heart rate isn't up you can get the booster and my heart rate was never up only my blood pressure(Further not clarified) and I was having tremors and I was having oh it was terrible, terrible and I felt terrible(Incomplete sentence)"Consumer stated, "No I don't wanna file a safety report but anyway the second dose was better I only had it was like one day over certain I  felt I didn't feel good and then I went to sleep and I felt better the next morning and then the third the first booster I got sick for two days but I got better quick very quickly  but the second booster I don't know what its gonna do but anyway the medical department are they the ones that can tell me what is in them?(Appropriate response was provided to the consumer over the call).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a licensed practical nurse refers to a 22 year old patient of unknown gender. On 06-AUG-2014 the patient was mistakenly vaccinated with a pediatric dose of VAQTA (route, dose and lot# not reported) instead of an adult dose of VAQTA. No adverse effects reported. Additional information has been requested.
Swollen arm, hard, redness, pain shooting up and down arm. Breast tenderness and arm pit pain
TINGLING AND NUMBNESS IN HANDS. HAS NOT GONE AWAY AS OF 10/6.   ANY SHAKE TO HANDS MAKE IT FEELS WORSE
I developed chills around 6:00 in the evening. About 8:00 I had a fever of 99.3 and about 10:00 my fever was 100.9. I became nauseous  around 2:00 am and had some diarrhea. I had some vomiting . I felt extremely tired and had fever and headache most of the next day. This was all on Wednesday night and Thursday. Friday morning my fever broke and I was fine.
Approx 2 hrs p/receiving vax; Pt began an unusual cry, high pitched scream that lasted 2-3 hrs by parents memory; Mom called ER & was told it was normal rxn;
About a week after receiving shots, my daughter developed a fever (102 degrees) severe coughing, vomiting, diarahhea, runny nose, and sticky yellow stuff in her eyes that glued them shut during the night, she would also pull at her ears.  She was constantly crying and you could tell she was hurting.
Patient called and said he had a red area starting at injection site about 5-6 inches. It is not hot or itchy. He will take some Ibuprofen.
I had a red, hard, spot on my arm that lasted over two weeks. I also had a bruise that was changing colors.  My arm was painful and the redness was spreading. I was given antibiotics for ten days afterwards. My mother also had a rash at the injection site, and was given same shot as me on same day. The lot number for my shot is 1808609. I have many pictures of the reaction if you want me to upload. Furthermore, the doctor said that my reaction would be aligned with a "moderna" reaction but is NOT typical of a J and J reaction (which is the shot that I had received and obtained a record of receiving from the Pharmacy).  I got an ultrasound and blood test around two weeks after vaccine, no blood clot found.
I had fatigue, nausea, headaches, and sinus pressure.  The major effects was the nausea and fatigue which is ongoing today.  The headaches lasted about 4 days.  I went to my doctor about this.  They did not do any test on me.
This case was reported by a nurse and described the occurrence of fever in a 62-year-old male patient who received SHINGRIX (batch number 9KT7T, expiry date 13th March 2021) for prophylaxis. On 11th December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 11th December 2018, several hours after receiving SHINGRIX, the patient experienced fever, injection site pain, joint pain, muscle pain and fatigue. On an unknown date, the outcome of the fever, injection site pain, joint pain, muscle pain and fatigue were recovered/resolved. It was unknown if the reporter considered the fever, injection site pain, joint pain, muscle pain and fatigue to be related to SHINGRIX. Additional details were provided as follows: Few hours after vaccination the patient experienced fever of 101 degrees F that lasted for about 12 hours, injection site pain, joint and muscle aches and fatigue that lasted for about 36 hours. This case was linked with cases US2018GSK226652 for unspecified number of patient's. Lab Comments: on an unknown date body temperature was found to be less than 101 degree F.
pt recvd vax & 1 day following 3rd dose pt presented w/chills, shaking, nausea, lethargy, diarrhea, weakness, cough, fever of 103, sepsis; Blood culture (x2) were neg, cxr revealed cardiomegaly; temp came down to nl;
pt recvd vax; central bruise w/ hard ctr; lg ring of erythema R buttock;
Around 8/10/22 patient developed spontaneous bruising in at least 4 different body sites without any predisposing trauma. Rather large ecchymoses on exam. No spontaneous bleeding or other signs of coagulopathy. Would note that at the time of the appearance of the bruises, the patient had been diagnosed with monkeypox (symptom onset 7/29/22, + PCR 8/1/22)  and treated with oral tecovirimat due to severe features (started on 8/3/22), although was already improving from the symptoms and signs of the disease. He had received the first dose of the Jynneos vaccine on 7/19/22. He was also taking Truvada for PreP and other medications listed previously.
Information has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 19-OCT-2015 the patient was vaccinated with a dose of improperly stored oral, ROTATEQ (lot # L008031 with expiration date of 03-AUG-2016; strength, dosage and frequency unspecified) (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
The patient arrived at the vaccine clinic requesting a Pfizer booster.  She provided a COVID-19 Vaccination Card that indicated she had only received her first and second primary doses of the Pfizer vaccine.  The second dose was administered 1/31/21, per the vaccination card provided.  The patient was given the Pfizer Bivalent booster as would be appropriate per the card provided.  Soon after administration a staff member with access reported that the patient had already received a Pfizer Bivalent booster in October 2022.  The patient was monitored for 15 minutes after the vaccine was administered and no adverse reactions were noted.  Patient also stated that she felt fine before leaving.
Fever for 2 days highest being 101.4, body aches, headache, swollen and  rash from injection site to elbow, Took benedryl for 2 days, rash and swelling stayed for about 3 to 4 days.
Full body, neck to feet muscles and bone aches still going on. On 3 dose of prednisone. Stiff body, hard to get out of bed.
PT VACCINATED WITH PFIZER 2/22/21 (LOT EL3302) + 3/15/21 (LOT EN6206). S/O BEGAN 8/24/2021, TESTED + 8/28/2021
Raised area to right arm, larger than a quarter. Arm is sore. Raised area did not occur with first dose.
Per conversation with father, pt has involuntary muscle movements  or twitching and change of demeanor with hallucinations.
dizzy, flushed , nausea, client was given water and orange juice, and started feeling better
Site: Swelling at Injection Site-Mild, Additional Details: palipitationsm and increased pressure in eyes, red dots around ankles 50-100 each side
the night after receiving the vaccine red and swelling on right side. Develop a fever 99-100 the next day. Treated with Tylenol. Seizure 4/27/2023. Mother noticed that baby looks confused and the baby started jerking and eyes started rolling. EMS was called and directed to take her home.  No ill contact at home. Spike fever again at 104.
Covid-19; Covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A female patient (unknown if pregnant) received BNT162b2 (COMIRNATY), 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: "Asthma" (unspecified if ongoing); "Type 2 Diabetes" (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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: had a mild case of COVID-19. The patient's other medications, family history, social history and other relevant information were reported as unknown. The patient mentioned that she personally had contracted COVID-19 after getting the bnt162b2 initial series and two boosters. The reporter considered events as caused by suspect product bnt162b2. The patient had a mild case of COVID-19 after receiving the bnt162b2 vaccine and two boosters.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.
That evening I lost my appetite had a fever and wasn't feeling well. The next day I was unable to swallow it was very scary because I couldn't even swallow water, then a few minutes later I could swallow. I started looking for a doctor because of this and I also had back pain. I still have the throat irritation which has never gone away. I constantly have to clear my throat. It bothers me everyday. I don't have post nasal drip or sinus issues, it just feels like something is stuck in my throat. This all started the day after the 2nd dose vaccination.
(R) thigh local reaction 45mm reaction red raised - no itching or burning - per provider - apply Cortisone cream and watch.
diagnosed with COVID monday, 14Jun2021 after completing Pfizer vaccine series.; diagnosed with COVID monday, 14Jun2021 after completing Pfizer vaccine series.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 14Jun2021, the patient experienced diagnosed with COVID Monday, 14Jun2021 after completing Pfizer vaccine series. On unspecified date, voice was raspy, she said she felt very tired. But hope to return to work on Wednesday (unspecified date). The patient underwent lab tests and procedures which included COVID-19: positive on 14Jun2021. The clinical outcome of events was unknown.  Information on Lot/Batch number has been requested.