chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 5/16/2021 I had a small red spot on the back of my right calf, it looked like a mosquito bite but it was too large like the size of a quarter, it was painful, then it grew the size of my calf, I was afraid it was a blood clot. I went to the emergency room and they ran a sonogram and they said it was cellulitis or skin infection. They gave me antibiotics.
No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 19-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S025258 and expiration date 05-NOV-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007: US-009507513-2001USA009210: US-009507513-2001USA009216: US-009507513-2001USA009217: US-009507513-2001USA009218: US-009507513-2001USA009219: US-009507513-2001USA009211: US-009507513-2001USA009212: US-009507513-2001USA009213: US-009507513-2001USA009214: US-009507513-2001USA009215: US-009507513-2001USA009200: US-009507513-2001USA009201: US-009507513-2001USA009202: US-009507513-2001USA009203: US-009507513-2001USA009204: US-009507513-2001USA009205: US-009507513-2001USA009206: US-009507513-2001USA009207: US-009507513-2001USA009208: US-009507513-2001USA009209: US-009507513-2001USA009220: US-009507513-2001USA009221: US-009507513-2001USA009222: US-009507513-2001USA009223: US-009507513-2001USA009224: US-009507513-2001USA009225: US-009507513-2001USA009226: US-009507513-2001USA009227: US-009507513-2001USA009228: US-009507513-2001USA009229: US-009507513-2001USA009230: US-009507513-2001USA009231: US-009507513-2001USA009232: US-009507513-2001USA009233: US-009507513-2001USA009234: US-009507513-2001USA009235: US-009507513-2001USA009236: US-009507513-2001USA009237: US-009507513-2001USA009238: US-009507513-2001USA009239: US-009507513-2001USA009240: US-009507513-2001USA009241: US-009507513-2001USA009242: US-009507513-2001USA009243: US-009507513-2001USA009244: US-009507513-2001USA009245: US-009507513-2001USA009246: US-009507513-2001USA009247: US-009507513-2001USA009248: US-009507513-2001USA009249: US-009507513-2001USA009190: US-009507513-2001USA009191: US-009507513-2001USA009192: US-009507513-2001USA009193: US-009507513-2001USA009194: US-009507513-2001USA009195: US-009507513-2001USA009196: US-009507513-2001USA009197: US-009507513-2001USA009198: US-009507513-2001USA009199: US-009507513-2001USA009250: US-009507513-2001USA009251: US-009507513-2001USA009252: US-009507513-2001USA009253: US-009507513-2001USA009254:
Tested positive for Covid 19 with flu like symptoms- low grade fever, cough, headache
Sore arm immediately. Fatigue, headache, chills and sweats started the next day and into day 3 after the vaccine was received.
This spontaneous report as received from a medical assistant refers to a 11 year old male patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 24-APR-2017 the patient was vaccinated with first dose of GARDASIL, Lot# M104929, expiration date 27-MAY2017 for prophylaxis. On 20-FEB-2017, the patient was vaccinated with second dose of GARDASIL, Lot# M104929, expiration date 27-MAY-2017 for prophylaxis. On 24-APR-2017, the patient was vaccinated with third dose of GARDASIL, Lot# M104929, expiration date 27-MAY2017 for prophylaxis. No adverse events.  No further information provided. Additional information has been requested.
Arrhythmia; Severe heart problems; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Arrhythmia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 ARRHYTHMIA (Arrhythmia) (seriousness criterion medically significant) and CARDIAC DISORDER (Severe heart problems). At the time of the report, ARRHYTHMIA (Arrhythmia) and CARDIAC DISORDER (Severe heart problems) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment medication was not provided.  This is a spontaneous case concerning  a female patient of unknown age,  with no reported medical history, who experienced the unexpected Serious (AESI) event of Arrhythmia and unexpected non-serious event of cardiac disorder. The events occurred on an unspecified date and unspecified dose of mRNA-1273 COVID 19 Vaccine. The events outcome were unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning  a female patient of unknown age,  with no reported medical history, who experienced the unexpected Serious (AESI) event of Arrhythmia and unexpected non-serious event of cardiac disorder. The events occurred on an unspecified date and unspecified dose of mRNA-1273 COVID 19 Vaccine. The events outcome were unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
I did have a fever and fatigue at the time of the second dose the following day. This lasted about two days. I'm not sure if the adverse event with my UTI was related to dose 1 or 2 due to having the same issues. My UTI are out of control since I received the vaccination. It's not normal for me to have them. I started to notice my adverse event around Feb2021.  Around January or February, I started to go to an urgent care, and I visited the doctor. If you contact my doctor, they will have the exact the dates and details.  Dr. and the urgent care center in Hospital Walk-In Clinic. My UTI were treated with antibiotics and I'm not sure what the name of it was.
Patient started to feel throat contractions and nausea within 5 minutes of the vaccine. He then started throwing up profusely.  Patient was given 25 mg of Promethazine IM within 10 minutes of start of the reaction.  He was held in the clinic for 30 minutes and checked on every 5 minutes.
This is the reporting of an administration error, and not of an adverse event that occurred.  On 11/16/2022, patient was administered Dose 3 of the Pfizer 6months-4yrs Monovalent Primary Series vaccine at the vaccination clinic, and it was later found that this dose was one day past the 10-weeks Beyond-Use-Date of 11/15/2022.  We reviewed CDC?s Interim Recommendations for COVID-19 Vaccine administration errors and deviations grid and contacted the vaccine manufacturer Pfizer on 11/16/2022.  Per manufacturer, since there is a ?2 days excursion time? plus the standard 10-week BUD, this vaccine dose that was one day past the 10-weeks BUD of 11/15/2022 is still considered valid. Patient does not need to repeat the dose since this vaccine dose was not considered as expired per this allowed 2-days excursion time.
Pt received a flu shot, Fluarix. After a few minutes pt said her throat felt kind of tight.  We told the pt that we will call 911 for her, but she declined. She said she might just having a panic attack. Pt said she has a medical condition, PTSD.  We took her back into the consultation room. After sitting down for a couples of minutes, she felt better. Adult Epipen was set on the counter if needed, but she said she does not need it. She felt better and left.
Patient noted redness at the site, approximately size of her hand, with a knot about the size of a nickel.  slightly warm to touch.  Has decreased in size, redness at time of this report.
Patient received the Moderna COVID-19 vaccine that was expired by one day; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 vaccine that was expired by one day) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 vaccine that was expired by one day). On 26-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 vaccine that was expired by one day) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.   This case was linked to MOD-2021-271870.   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Follow-up information included no new information
Passed out 1/26/21 evening for 45-50 seconds similar to when he had COVID. Consulted with PMD. Reported mild pain, moderate fever 101, chills, and joint pains. Severe headache.
Frontal headache 6 PM lasting through 5/18/21  afternoon Muscle spasms throughout the body 8:30 PM through to 5/17/21-10 AM Dry cough/upper respiratory tightness 10 PM through 5/18/21 late evening Insomnia 10 PM through 5/20/21 mid-afternoon General exhaustion 5/15-11 am through mid-June 2021 (between 4-5 weeks) Sensitivity to light 5/15/21-9 AM though June 2021 Skin irritations/hives 5/17/21 5 am through late June 2021
I was diagnosed with Narcolepsy 5/2018. I am now on daily medication to treat this. Modafinil and ADDERALL. I have documentation of flu vaccines I have recieved since 2011. Due to the nature of my diagnosis, I am unable to determine which, if any of those vaccines were responsible. I know that GlaxoSmithKine had a vaccine in 2009-2010 that was responsible for the development of narcolepsy in some patients over seas.  And I am suspicious that I have also been affected by an ingredient used. 2012-Lot #AFLUA716BA; 2013-Lot# 35SN5; 2014-Novartis 160984; 2015-Novartis 713906; 2016 FLUCELVAX 185887; 2017 ?; 2018 Lot # YT38507A. The facility I work for mandates annual flu vaccines. I think it is kind of significant that 3 nurses in my department have been diagnosed with Narcolepsy in the last year.
Started with significant body aches and weakness on the evening after the  vaccination.  Less than 24 hours after vaccination, onset of severe nausea, in addition to the body aches and weakness.  Currently 55+ hours post vaccination and side effects still persist.  Unable to eat.
Right arm: redness, sore, swelling, chills and fever up to 102 degrees. Loss of appetite and sleep. Infection/right arm, cellulitis.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. The nurse provided that in May 2016, she had a temperature excursion (to 34.4F for 8 hours and 24 minutes) with PEDVAXHIB (lot # L012835 with expiration date 11-MAR-2018). On unknown dates in 2016, the patients were administered the improperly stored doses of PEDVAXHIB (dose and route were not reported). On an unknown date in 2016, the vaccines had a second excursion to 28.9F for 8 hours cycling every 20 minutes. No vaccines were administered since the second excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Rash noticed by parent starting on 7/4/07 with areas becoming pustular. On 7/5/07 7 pustular areas on chin, 3 pustular areas on back with 1 x 2 flat erythematous area diagnosed with Varicella.
No other AE details; temperature excursion; This spontaneous report has been received from a registered nurse referring to a 2 year old patient of unknown gender. The patient's pertinent medical history, concomitant drugs and drug allergies were not reported.  On 17-FEB-2020 the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (0.5 ml, lot # T017688, expiration date 21-MAY-2022, strength and route were not reported) for prophylaxis. No other adverse event details available at this time.       Temperature excursion of this vaccine was -13.3 degrees Celsius for 4 hours and 15 minutes without any previous temperature excursion (incorrect product storage). The digital data logger was involved.
Patient received the adult 12 & over vaccine on 1/30 and again on 2/20. Patient was 11 at both vaccine appointments. According to records patient was registered and processed as 12 & over. Patient mother reports patient has had no adverse effects, but expressed concerns over patient receiving a higher than recommended dose.
completed Twinrix series,  antibodies were not present; First dose on 13Jul2017, second on 23Aug2017, third 26Feb2018; This case was reported by a pharmacist and described the occurrence of therapy non-responder in a 60-year-old female patient who received HAB (Twinrix adult) (batch number Z75Y2, expiry date 15th March 2020) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix adult) (batch number EF773, expiry date 29th September 2018) for prophylaxis, hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix adult) (batch number EF773, expiry date 29th September 2018) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th February 2018, the patient received the 3rd dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On 23rd August 2017, the patient received the 2nd dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On 13th July 2017, the patient received the 1st dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On 23rd August 2017, not applicable after receiving Twinrix adult, Twinrix Pre-Filled Syringe Device, Twinrix adult and Twinrix Pre-Filled Syringe Device, unknown after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device and not applicable after receiving Twinrix adult, Twinrix Pre-Filled Syringe Device, Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder and drug dose administration interval too long were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received 3 dose of Twinrix adult and the patient's physician checked for antibodies and they were not present, which led to therapy non-responder. The physician told patient that she was not protected against Hepatitis A and Hepatitis B. The patient received 2nd dose of twinrix adult later than the recommended time interval, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Pain at injection site, malaise, chills, muscle aches, cough and sore throat (like having a cold)
On my way home (about 2:45-2:50), I developed tingling in my lips and my ears felt numb.  I pulled into the parking garage at a hospital on my way home and by then my knees felt weak and numb too.   After waiting a while in the hospital my legs began to swell and my pants felt tight from the knee down.   Later the top of my head felt numb but my lips felt better.  They administered 50 mg of Benadryl about 6 pm and my leg swelling went down and I felt good enough to go home by 7pm.
mild erythema & induration 2.5cm x 2.5;no resp problems;
Autoimmune hemolytic anemia; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL 6206), via an unspecified route of administration, administered in arm left on 09Mar2021 (at the age of 70-years-old) as dose 2, single for COVID-19 immunisation. Medical history included chronic lymphocytic leukaemia (CLL) and known allergies: Sulfa. There were no concomitant medications. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. The patient experienced autoimmune hemolytic anemia on 29Mar2021. The event resulted in doctor or other healthcare professional office/clinic visit, hospitalization, life threatening illness (immediate risk of death from the event). The patient was hospitalized for the event for 10 days. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 10Aug2021. Therapeutic measures were taken as a result of autoimmune hemolytic anemia which included transfusions and steroids. The outcome of the event was not recovered.    No follow-up attempts are possible. No further information is expected.
3/20/2021   Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening .  During the observation period, she experienced an adverse reaction with the following symptoms:  rapid heart rate.   Assessment : Time of assessment 2:34pm. Anxious and Tachycardia. VS taken at 2;34 bp - 142/100, P- 122, RECHECK AT 2:40 PM , bp - 154/92, P- 92, AT 2:52 pm BP - 153/92, P- 89, Water offered and accepted. Patient reports feeling like she is having a panic attack.   Actions taken:  VS taken x 3, water offered and accepted, 30 mins in observation       Medications administered: No medication administered.   Disposition:The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system.      Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 3/20/2021  2:26 PM 0.3 mL 12/11/2020 Intramuscular   Manufacturer: Pfizer, Inc
Patient was administered COVID-19 Moderna 19 vaccination. Patient does not meet the age requirement.. Moderna vaccine has only been indicated for use emergency in individuals over the age of 18. This patient is 16.  Vaccine administration error noted on June 1, 2021. Patient's guardian (mother) contacted on June 2, 2021 and made aware of vaccine administration error . Reports no adverse reaction.
Got it on Thurs Friday and Sat feel weak cold shaking. Sat night throwing up queasy cold all day Sunday early Monday morning went to the hospital and got medicine. I don't' known if it was the shot but I had every thing that was on the paper it was the sickest I had been in a long time.
On April 1st, my temperature was 104. My vaccinated arm was swollen, had body aches, chill and headache. I felt like I was developing a cold/flu. On April 2,  I was congested, body ache, 103 fever, chills and headache.  Everything ached even gums. Fever subsided on April 3rd but all flu symptoms remained, congestion worsen.  The first day that I felt good enough to get around was April 10, no more body aches but tired. Today is April12, flu symptoms have subsided but some congestion and stuffy nose remain.  I have not seen my health care provider hoping that the symptoms will subside which they are.
A Pfizer COVID-19 vaccination was given to the patient. A few minutes after the vaccination when the pt was sitting in the post-vaccine waiting area the pt appeared to tense up. The pt was stiff, started shaking and the eyes rolled back into their head. I'd estimate that event lasted less than 15-20 seconds total.
Immediate left side (injection side) headache.; Intense headache, neck, facial and cranial pain; Intense headache, neck, facial and cranial pain; Extreme vertigo within 1 hour; loose stool; Nausea; vomiting; Swollen; itchy hives; itchy hives; Swollen left eye; This is a spontaneous report from a contactable HCP and a consumer (the patient).  A 44-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 03Apr2021 11:30 (Batch/Lot Number: EW0150) as single dose  for covid-19 immunisation  .  Medical history included migraine, demyelination , post-traumatic stress disorder.     The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported.  The patient experienced immediate left side (injection side) headache.  on 03Apr2021 11:45 with outcome of not recovered , intense headache, neck, facial and cranial pain on 03Apr2021 11:45 with outcome of not recovered , extreme vertigo within 1 hour  on 03Apr2021 11:45 with outcome of not recovered , loose stool  on 03Apr2021 11:45 with outcome of not recovered , nausea on 03Apr2021 11:45 with outcome of not recovered , vomiting  on 03Apr2021 11:45 with outcome of not recovered , swollen on 03Apr2021 11:45 with outcome of not recovered , itchy hives  on 03Apr2021 11:45 with outcome of not recovered , swollen left eye on 03Apr2021 11:45 with outcome of not recovered. All the reported events were considered Important Medical Events.  Course of the event: Immediate left side (injection side) headache. Spread to entire head within 30 minutes. Intense headache, neck, facial and cranial pain persists at hour 53.  Extreme vertigo within 1 hour, persisting now at hour 53.  Nausea, vomiting and loose stool within 6 hours. Vomiting ceased at 48 hours post 1st shot vaccination. Nausea and diarrhea persists at hour 53.  Swollen, itchy hives, injection side within 40 hours, spread to neck and face. Swollen left eye, within 24 hours, waning at hour 53.    No follow-up attempts are needed. No further information is expected.
Swollen tongue, tight throat and chest, dizziness, light headedness, and nausea.  Given epinephrine, Benadryl and Zofram
right arm extensive erythematous, papular rash with crusting lasting more than 10 days, radiating from right lateral upper arm to right wrist.  some pain and mild itching.
Swollen, hot to touch, painful.  Ice packs, Tylenol, Benadryl given.