chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hot, flushed within 20 minutes, body aches, fever, headache, cough and all Covid symptoms by following day. Sick for 5 consecutive days before taking Covid Test.  Tested positive.   Starting antibiotics and steroids also going for infusion
bed was wet and his pillow/sweats at night have continued; Ran a temperature Sunday and Monday; really bad tired; no energy; no appetite; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (really bad tired), ASTHENIA (no energy), DECREASED APPETITE (no appetite), NIGHT SWEATS (bed was wet and his pillow/sweats at night have continued) and PYREXIA (Ran a temperature Sunday and Monday) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (NO reported medical history).   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 09-Jan-2021, the patient experienced FATIGUE (really bad tired), ASTHENIA (no energy) and DECREASED APPETITE (no appetite). On 10-Jan-2021, the patient experienced NIGHT SWEATS (bed was wet and his pillow/sweats at night have continued) and PYREXIA (Ran a temperature Sunday and Monday). On 09-Jan-2021, FATIGUE (really bad tired), ASTHENIA (no energy) and DECREASED APPETITE (no appetite) had resolved. At the time of the report, NIGHT SWEATS (bed was wet and his pillow/sweats at night have continued) and PYREXIA (Ran a temperature Sunday and Monday) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications was reported.   No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
0.25 ml received as first dose/Patient received half dose of Moderna COVID-19 vaccine instead of a full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (0.25 ml received as first dose/Patient received half dose of Moderna COVID-19 vaccine instead of a full dose) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 07-Jan-2022, the patient experienced ACCIDENTAL UNDERDOSE (0.25 ml received as first dose/Patient received half dose of Moderna COVID-19 vaccine instead of a full dose). At the time of the report, ACCIDENTAL UNDERDOSE (0.25 ml received as first dose/Patient received half dose of Moderna COVID-19 vaccine instead of a full dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 23-FEB-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ lot # L008057 and expiration date 01-DEC-2016, 2 ml administered orally. No adverse effects were reported. The vaccine had one temperature excursion of 48 hours with a lowest recorded temperature of 34 Fahrenheit (F) (1.111111111 Celsius (C)). The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Severe headache bordering migraine; Severe headache bordering migraine; Muscle stiffness in neck and shoulders; Right arm injection soreness; Tiredness; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the right arm on 27Apr2021 at 16:15 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. 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 valsartan (MANUFACTURER UNKNOWN) and fluoxetine hydrochloride (PROZAC); both taken for unknown indications from an unknown date and unknown if ongoing. The patient previously took diphenhydramine hydrochloride (BENADRYL) for unknown indication and experienced drug allergy. On 27Apr2021 at 16:45, the patient experienced severe headache bordering migraine and took migraine medicine to calm pain. She had continuing dull headache, muscle stiffness in neck and shoulders, right arm injection soreness and tiredness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with unspecified migraine medication and paracetamol (TYLENOL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe headache bordering migraine, muscle stiffness in neck and shoulders, right arm injection soreness and tiredness was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
I started getting rashes after I got the vaccine.  They clear up completely with zyrtec but every few days I get hives and rashes.  I tried taking zyrtec higher dose (as recommended by doctor) along with prilosec (I think) then switching to lower dose but every time I come off the zyrtec the rashes and hives come back.  I was taking zyrtec every other day for a while now then tried coming off it again on 1/6/23 (I think) and I had a rash this morning (1/10/23).  The rash comes with hives, appears in different spots and can be painful.  Itch cream helps some but zyrtec completely fixes it.  (the doctor visit was over the phone so I didn't mark it below)
Post vax, had LOC with seizure. Moved to floor. Ammonia inhalent used. Immediate response with open eyes, oriented to person/place. Pulse at 15:20 was 80. Requested mother to remain in waiting room. 30 minutes, post vax, increased orientation/alertness. Referred. Sent home with inhalent and instructions. Child had not eaten all day.
weird sensation in lt leg w/numbness;on exam numb to touch;deep tendon reflexes similar on both side;able to walk;not able to dorsiflex on lt side, some weakness;does not present like GBS;
Vomiting, nausea, fever of 100.8 for 12 hours, fatigue, panic/anxiety attacks that clonazepam didn't work on, severe injection site pain 8/10.
Information has been received from a physician concerning a 4-year-old female patient with mild eczema who on 09/19/2002 in the PM was vaccinated with a second dose hepatitis A virus vaccine inactivated (reported lot # 728A9, not valid for this product) in her left leg.  At the same time she received a sixth dose of diphtheria toxoid/pertussis vaccine/tetanus toxoid (reported lot # 526A9) in the left leg.  On the morning of 09/20/2002, the patient developed a 6 x 8- centimeter area of induration to the left thigh at the area of vaccination, also described as "severe site of administration reaction"; and the reported event onset was 12-24 hours after vaccine administration.  The patient was taken to the emergency room because her primary care physician was not open on the weekend; the areas around the hepatitis A virus vaccine inactivated vaccination site were determined to be "cellulitic".  The reporter indicated the patient was treated with an oral steroid (name and dose not reported) and it was also noted the patient was put on a course of unnamed antibiotics.  The reporter indicated the patient had no known adverse events following prior vaccinations, and no laboratory tests were performed.  It was noted the patient saw her primary care physician on 09/23/2002 and was reported as "doing better".  She was instructed to finish the antibiotics as ordered.  It was noted the patient recovered on 09/25/2002.  The reporter mentioned that "several" patients also had an experience following vaccination with hepatitis A virus vaccine inactivated (WAES # 0301USA00760).  Additional information has been requested.
Administration of Expired Vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Jun-2021 and was forwarded to Moderna on 25-Jun-2021.    This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) in a 30-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment was provided by the reporter.
about 230PM 8SEP most of rt thigh was red & swollen & pt felt unusually hot; used cold packs on thigh almost constantly for 6-8hrs; 5PM pt started almost constant high pitched screaming & crying that lasted about 4 1/2 hrs;
This initial case was missing the following minimum criteria: no specified suspect product was present. Upon receipt of follow-up information on 05MAR2015, this case now contains all required information to be considered valid. Follow-up (05MAR2015): This is a spontaneous report from a contactable consumer reporting for herself. A female patient of an unspecified age and ethnicity received a single dose of TRUMENBA via an unspecified route of administration on 02MAR2015. The patient medical history and concomitant medications were not reported. The patient got red bumps near the injection site on 04MAR2015. Outcome of event was unknown. The consumer asked if other reports of red bumps near the injection site were received. Follow-up (10APR2015): Follow-up attempts completed. No further information expected.
This spontaneous report was received from a healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On unknown dates in June 2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M005714, expiration date 03-OCT-2017, exact doses and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccines were exposed to temperature of 9 Fahrenheit degrees (3 cycles) for 72 hours before administration to the patients. No previous temperature excursion was reported. No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
partial dose of FLUZONE HD due to some of the vaccine leaking during administration, caller reported needle was intact in syringe and intact in arm but patient felt liquid running down arm, with no AE; partial dose of FLUZONE HD due to some of the vaccine leaking during administration, caller reported needle was intact in syringe and intact in arm but patient felt liquid running down arm, with no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via the agency (Reference number- 00331639) and transmitted to Sanofi on 26-Oct-2020.  This case involves a 71-year-old female patient who received a partial dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] lot number UJ535AB, expiry date 30-Jun-2021) via an intramuscular route in the right deltoid for prophylactic vaccination on 26-Oct-2020.  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  It was a case of actual medication error due to vaccine underdose and Exposure via skin contact.  Pharmacist reporting patient received partial dose of FLUZONE HD due to some of the vaccine leaking during administration.  Caller reported needle was intact in syringe and intact in arm but patient felt liquid running down arm.  Caller reporting unable to tell where the leaking was coming from- the point of needle insertion or from the barrel of the syringe.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
About 12 hours after receiving the shot (11:30pm) I experienced fatigue, body aches, and chills. I took 650 APAP and 400mg Advil, drank some water and went to bed. I woke up this morning still feeling slightly achy but no chills and no fatigue. These side effects are common and known based on the VIS provided to me but felt the need to still report it for documentation purposes.
Covid/Vaccine Arm. Left arm injection site remains red, swollen, warm, sometimes itchy
Pretty significant pain in my both of my lower legs like it almost feels like shin splint on top of the leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 01), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset May2021, outcome "unknown", described as "Pretty significant pain in my both of my lower legs like it almost feels like shin splint on top of the leg".  Additional information: The patient got second dose of the vaccine on Wednesday and was having some pretty significant pain in my both of lower legs like it almost feels like shin splint on top of the leg and was unclear if something should be done.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
(R) thigh became red, swollen, hard, & tender. Advised to apply ice compress, antibiotic was not ordered. Patient to follow-up if symptoms persist. (Pt. followed up with MD).
Information received from the review of scientific literature on 02JUL2018. This is case 2 of 6 (18000138LT, 18000139LT,18000140LT, 18000141LT,18000142LT, 18000143LT) The article notes a 27-year-old active duty male who presented to the ED with 3 days of left-sided pleuritic chest pain and shortness of breath 11 days after receiving vaccinations including ACAM2000. His pain was worsened when lying flat and improved with sitting up. His ECG showed ST elevation and PR repressions with a positive troponin-I of 5.69 (normal <0.03 ng/mL). A bedside transthoracic echocardiogram showed a small pericardial effusion without signs of cardiac tamponade. Cardiology at an outside hospital was consulted and the patient was transferred for further care of myopericarditis. He was discharged 3 days later on ibuprofen with cardiology follow-up. A repeat echocardiogram showed resolution of the pericardial effusion. Approximately 2 weeks after discharge, the patient returned to the ED with similar chest pain. His troponin-I was negative, a bedside transthoracic echocardiogram showed no evidence of pericardial effusion, and his ECG was consistent with resolving pericarditis. The patient was discharged to follow-up with cardiology. At the follow-up, he was given a medical profile, made non-deployable, and started on a 3-month regimen of colchicine. Additional information has been requested.
pt was burning up; mom put pt in cool H20 to bring down temp; pt began shaking all over (entire body) for a few seconds; MD recommends DT only;
Moderna COVID-19 Vaccine EUA After receiving the vaccine, I felt my throat swell up a bit, which caused me to slightly panic during the 15 minute observational period; however, it went away after approximately 5 minutes. I initially wasn't convinced it had anything to do with the vaccine. Later that day, I went into work for third shift. At approximately 1:30 am (approx 11 hrs. after the vaccine), I began to feel very ill. I developed flu like symptoms and a headache, which caused me to leave work. I continued having flu symptoms, chills, nausea, body aches, and a very severe migraine on and off until I woke up on  01-22-20 at approximately 6:00 am. At this time, the migraine had subsided and I just had some minor body aches,, which over the next 24 hrs. also went away. The migraine should be noted as debilitating to the point I was dizzy, my mind was foggy, but worst of all, the pain was so bad I was constantly nauseous and my eyes were regularly watering.   I never was tested for COVID-19; however, I believe my family had potentially had the virus in October. My wife and I exhibited many of the signs and symptoms of the virus, including my wife losing taste and smell for an extended period of time.
No adverse event; Caller stated the PEDVAX HIB was administered after a temperature excursion.; This spontaneous report was received from a female consumer worker referring to a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 15-MAR-2022, the patient was vaccinated with an improperly stored dose of haemophilus b, conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) at the dose of 0.5 milliliter (mL), for prophylaxis ,0.5ml, lot #T030711, expiration date: 15-APR-2023, (strength, frequency, anatomical injection site and route of administration and were not provided ; lot number T030711 has been verify to be a valid lot number with an expiration date on 15-APR-2023)).  The haemophilus b, conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was stored on 23-Feb-2022, at a temperature of 46.4 degrees Fahrenheit (°F) for the time frame of 1 hour, and 48.4°F for the timeframe of 2 hours 25 minutes. On 03-MAR-2022, it was stores at 49.3 °F for the time frame of 2 hours 50 minutes. On 08-MAR-2022 it was stored at 46°F for a timeframe of 30 minutes. On 09-MAR-2022 it was stores at 47.8 °F for the time frame of 3 hour 56 minutes. There was no previous temperature excursion. No additional adverse events reported.
Patient stated she had some itching that started about two days after the shot and also had some small bruising around the injection site that she thought may have been due to her itching but was unsure.  The patient was counseled to take OTC antihistamines to help with itching.
At about 6:30 pm., customer called + said she was having severe shoulder pain w/left arm we gave her PNEUMOVAX in. She said she's taken a codeine pain killer + was still having pain. I told her she could apply ice tonight + heat tomorrow. Told her to call us + let us know how she came out.
Information has been received from a registered nurse concerning a 33 year old female employee who on 4/5/04 was vaccinated SC in the left arm with a dose of varicella virus vaccine live (lot # 639782/0535N). Within 24 hours post vaccination, the patient developed a local reaction that included swelling, redness, and itching. The reaction maxed out at 48 hours post vaccination. The patient did not seek medical attention and did not require any kind of treatment. After four days, the patient completely recovered. A product quality complaint was not involved. Additional information has been request.
administered the expired vaccine with no AE; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case received from consumer/non-healthcare professional via call center via Medical Information (Reference number- 00814713).  This case is linked to case 2021SA345109(CLUSTER).  This case involves a 39-year-old male patient who received the expired dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (expired product administered).  The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  On 03-Sep-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: QFAA2017 and expiry date: 30-Jun-2021) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  It was reported "Stated that they gave 15 patients expired Flublok vaccine, and wants to know what to do."  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a third party administrator on behalf of a pharmacy concerning a female patient, who on 14DEC2013 was vaccinated with PNEUMOVAX vaccine with lot # J009827 and an expiration date of 01AUG2014. The patient experienced an adverse reaction (not further specified). Additional information has been requested.
The night of the vaccine I feel asleep by 7pm exhuasted,  next day I woke up (8/10) with bad sacaral pain, body aches, headach, and a sensation of someone putting icy hot or mentol across my arms and neck.   I took tylenol and motrin throughout the day, the menthol sensation lasted intermittently from 8/10 until 9/3.  The sacral pain came back 8/16-8/22 causing bad pain in that area radiating down to my thighs and causing my blood pressure to elevate.  I went to my family doctor she did a sacral mri,  When the pain left my blood pressure came down, i had the mentol sensations occasionaly then I would have pressure in my calfs, feeling of weakness but I was not weak and able to use them.  My doctor then referreed me to a neurologist.    This all started the day after my vacine.  It has been torture I have been better for a few days with still an occasional pressure or weak feeling in my calfs.