chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Started with not being able to wake up but being aware of surroundings. He then got very dizzy and passed out. 911 was called and EMS was dispatched to his home. He experienced cardiac arrest and need to be resuscitated 7 times. He was flighted to hospital where he had surgery to place a pacemaker.
Stiff arm started one hour after injection. Woke up this morning with chills but no fever. Have had chills and fatigue all day.
Starting in early April of 2021, I began having excessive periods every two to three weeks.  This was a new system that I had never had before.  These periods continue to the present.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 28-Jul-2022; No adverse event; Patient administered the vaccine after the 30 days by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 28-Jul-2022) and NO ADVERSE EVENT (No adverse event) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 28-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 28-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 28-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 28-Jul-2022).    No concomitant medications were reported.  The patient received half dose of Moderna vaccine.  The vial had not undergone any temperature excursions.  The vial was initially stored in the refrigerator on 04-Jun-2022 and 35 vials were affected.  No treatment medications were reported.
My wife and I went together, she to get her flu shot, me to get my booster shot.  At first the technician brought in 2 Covid Booster shots, and no flu shot.  When he asked my wife about getting the Covid booster shot, she corrected him and said she was there to get the flu shot, not the covid booster shot.  He left and brought back a new  shot for my wife.  He then gave us the shots, theoretically giving me the covid booster, and my wife the flu shot.  My wife and I have received the flu shot every year for over 20 years, and neither of us have had a reaction.  I had my flu shot earlier this year and had no reaction.   On the other hand, my wife and I have each had headaches after each of the first 2 covid shots we received that lasted about 2 days.  After the shots we received on 12/4/21, I had no reaction whatsover, which is unusual for me with the covid shots, and my wife had a typical covid reaction after receiving what we thought was a flu shot.  Her reaction was redness around the shot area, some swelling, and a mild fever around the shot area, and a headache that lasted off and on for 4 days.  We believe that the technician did the paperwork as if he had given us the appropriate shots, but inadvertently switched the shots when he actually administered the shots.  This would make sense given our reactions to the shots subsequently, where I reacted as normal as if I had received a flu shot (though I should have received the covid booster), and my wife reacted as if she had received a covid booster (though she was supposed to have received the flu shot).  This leaves a two-fold problem.  1) I am not covered for the booster because I got the wrong shot, but the paperwork indicates otherwise.   2) My wife is not covered for the flu because she got the wrong shot, and her paperwork indicates she has not received the covid booster though we believe that she actually has.  We went and spoke to the pharmacist who told us there is nothing they can do because their paperwork indicates they gave the right shots, and cannot view what actually happened because there are no cameras in the room where the shots are administered.  I contacted my physician, and they indicated they have no test they can provide to see if I actually received the covid booster.  They suggested I contact the CDC, which I did today.  They also indicated they have no test that could tell if I received the right shot, and suggested I log an incident with the VAERS to see if they have a solution to this predicament, which is ultimately that I believe I did not receive the correct covid booster shot and I am thus not protected as the CDS strongly recommends (and I would like to be and certainly tried to be).  Is there a test that would show my level of protection now, or could I be approved to receive the booster shot again, and if so, what would the ramifications of receiving the Covid booster shot potentially twice.  The pharmacist indicated she would be more worried about not receiving the booster at all, as opposed to receiving the booster twice.  Please assist so I can be properly covered.
COVID breakthrough case. I received my 1st booster shot on 12/06/2021 and I tested positive on 01/23/2021 I only had allergy like symptoms nothing severe and I didn't even noticed that I had COVID after my husband tested positive and my son. Then I decided to do a test on me. I went to the emergency room because I had Urinary tract infections and when they checked my blood pressure they said it was high. I never had an high blood pressure not sure where this came from.  It stays up 130/90. Even if am just sitting down its still high. When I get high blood pressure I also get a headache. The ER treated me for migraine and my blood pressure went down but later it went up again. I haven't seen my doc yet am still waiting for an appointment. The ER told me just to monitor my blood pressure they don't prescribe medications any more. They told me if it goes up to go to ER. Am doing everything they said still its high.
I began to experience in May that my menstrual cycle duration has been heavier and longer and much more painful to the point of waking up and crying; I did not correlate it with anything else over the summer. The evening of October 8th, 2021 I went to urgent care with severe cramping and lower abdominal pain, urinary test done, worried about any tearing with ovaries, sent to ER and had an ultrasound and MRI done, resulting in two large cysts on ovaries. No prior history of issues with menstrual cycle or cysts prior to this. Followed up with OBGYN, went over MRI to make sure there were no twisting of ovaries. Low-dose birth control was given, Junel, which was started last week, to prevent other cysts.
I administered the Pfizer 3-4 (Covid) 23-24 Toddler dose without diluting the vaccine first on Sunday 10/22/23 around 10:30am to a 4 year old.  I contacted the patient's father later that afternoon around 4:30pm when I realized what happened.  The father stated that the patient did not have any adverse reactions.  I explained that I would follow up with the manufacturer and primary doctor on Monday morning when they opened and to monitor the child for any signs of reactions.  I spoke with a Pfizer rep on Monday, 10/23/23 and was told that if the child had no local or systemic reactions that they should still receive their final 3rd dose 8 weeks later but if they had any reactions to discuss with their primary doctor and make a decision if to give the final dose.  I spoke with the doctor's office and they said to have the patient follow the directions from Pfizer.  I then called the patient's father and explained what Pfizer and the doctor's office stated.  He said the child was fine and still not showing any signs of adverse reactions.
Two weeks post vax, the pt developed a maculopapular rash that covered her entire body, including the soles of her feet and the palms of her hands. The rash improved after treatment with diphenhydramine. The reporter indicated that the pt has a family history of allergic reactions.
On 3/14/00, the pt was given varivax in the right thigh. On 3/25/00 the pt was seen with 1 cm lesion that was firm and swollen. Treated with bactioban for possible secondary infection. On 3/30/00 was seen by MD and was healing well.
report a temperature excursion; No other AE reported; This spontaneous report was received from an other type of reporter and  refers to a patient of unknown age and gender. No information was given regarding the patient's concurrent conditions, concomitant medications or medical history.  On 12-JAN-2021, the patient was vaccinated with an improperly stored pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # T007790 with expiration date on 03-DEC-2021, 0.5 milliliter for prophylaxis (route of administration was not reported). However, no adverse events were reported.   This temperature excursion occurred on an unknown date, at a 31.2 F temperature for 30 minutes. There was no previous temperature excursion reported and the call was due to data logger. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T007790; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. No temperature excursion has happened. No adverse event was occurred. Vaccine placed in refrigerator was on 01-Mar-2022 Treatment information was not provided
Gout; A spontaneous report was received from a consumer concerning a 91-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed gout.  The patient's medical history was not provided. Current condition included deafness. The concomitant medications reported included metoprolol, allopurinol, colesevelam hcl, gabapentin, rivaroxaban, levothyroxine and nateglinide for unspecified indications.   On 04 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection. On the same day, the patient developed gout.   Treatment for the event included paracetamol.   Action taken with mRNA-1273 in response to the event was unknown.  The outcome for the event gout was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of gout, a causal relationship cannot be excluded.  However, considering this elderly patient takes concomitant allopurinol, the underlying condition may have been contributory. Follow-up information on medical history is requested.
Fever, 2" rash around injection site, left upper arm edema and warmth.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for elevated PSA, parkinson's disease, htn, advanced age, obesity, hyperlipidemia. Received 2nd dose of Moderna on 2/18/21. Deceased 4/27/21 under the care of hospice. No documentation of recent illness available.
Initial report received from a non-health care professional on 03 October 2013. A 91 years old male patient, medical history and concomitant medications were not reported, had received a dose of FLUZONE HD (Lot number, route and site of vaccination were not reported), on an unspecified date in 2013. On an unspecified date, after receiving vaccine the patient experienced severe chills and fever. At this time of this report the outcome of adverse event was unknown. Documents held by sender: none.
12x19 cm, red, swollen, warm to the touch area on L upper arm.  Advised BENADRYL, warm compresses and monitoring.
EXCEMA ON HANDS, TOES, SHINS.  RED RASH FROM WAIST TO MID THIGH.
This spontaneous report was received from a medial assistant and refers an unknown number of patients of unknown demographics. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. The reporter stated that an unknown dates since 12-JAN-2017, the patients received an improperly stored doses of GARDASIL 9 (involved lot numbers: M026306 with expiration date at 30-APR-2018 and M034780 with expiration date at 15-APR-2019; dose and route of administration were not reported) for prophylaxis. The administered doses of vaccine were exposed to a temperature of 46 and 77 (unit nor provided) for 39 minutes. No previous temperature excursion was reported. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA004067: US-009507513-1702USA000822: US-009507513-1702USA004069: US-009507513-1702USA004070: US-009507513-1702USA004071: US-009507513-1702USA004066: US-009507513-1702USA004068.
31DEC98 mom reported vesicles on chest (7);back (8) afeb;
Not received 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in July 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Not received 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 13-JUL-2023 Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Pt experienced fatigue & SOB was hospitalized on 21MAY90 for a wk; tentative dx of viral myocarditis was made; Also experienced arthritic pain;
Pt c/o of chills all day, T103.6, arm had great deal of pain, developed a streaky rash on inside of lt arm, to body, arm became hard, red & swollen. Went to ER.
Developed croupy cough & temp 100.6 per mom - 100-101 highest taken to ER 11FEB91 - CXR -dx rt otitis media & possible early PNE.Given Augmentin Q8hr x 7 days.
He was diagnosed with COVID 19; He was diagnosed with COVID 19; This is a spontaneous report from a contactable consumer (front line hospital worker) reporting for himself, received via a Pfizer sales representative. This male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date in Dec2020, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in Dec2020, after vaccination, the patient was diagnosed with COVID 19 with unknown outcome.  Information on the lot/batch number has been requested.
FEVER 105, RASH AROUND FACE THAT SPREAD OVER BODY.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 28-FEB-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M025871, expiration date: 24-MAY-2018 (site, dose 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 vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required data has been obtained. Sender's Comments: US-009507513-1611USA004113.
1 week after H1N1 injection  knot came up on pt's wrist. Quarter-sized, fluid filled and hot. On 11/05/2009 lower arm had swelled and pt went to drs. Was given a shot (not sure of what) which helped. 1 week later the knot popped and disappeared into a pea-sized hard knot. Itchy. No problem at site of injection itself only lower arm.
After initial vaccination a lump with redness and itchy skin appeared. It went away after a 4 days except for the lump. Almost exactly two weeks after the vaccination, the lump still exists but an itchy rash has a appeared approximately 2 inches in diameter. I have applied a corticosteroid and am beginning to take Benadryl to hopefully help.
(Lt) arm where injection given very red. Spread down upper arm to axilla - developed cellulitis. Treated with ANCEF, prednisone and then BACTRIM. Had fever with reaction.
On June 10th I began to have chest pain.  It was  very bad so I went to the ER.   10 minutes after arriving I coded and had to have CPR and shock my heart back.  I was airlifted to Hospital where they placed a stent in my LAD due to 100% blockage.  No other blockage was found in any other artery.  I spent two more days in the hospital and have have been recovering at home.
Patient c/o  mild chest tightness, dizziness  and nausea about 7 minutes after received Jansen cover-19 while siting in observation area around 11:43. He fainted right after. Patient was lowed from chair to yoga mat with assistance of paramedics. He was positioned in supine  with legs elevated. Patient regained consciousness once laying supine. He denies chest pain. His first set of vital signs: BP 140/87; P 51; Res 18; O2 saturation 98% at 11:45. Patient reviewed his past medical history including hypertension and palpitation. He states he des not take medication for hypertension and he takes atenolol 25mg PRN for palpitation. Last time he took it was week and half ago. EKG was performed by paramedics and it was sinus bradycardia. Patient states he felt back to normal. His VS at 11:50: BP 131/85; P 57; Res 18. Assisted Patient sitting up then standing up. Patient denies dizziness, chest pain or tightness. His standing BP was 142/82. Patient was observed for another 15 minutes then walked out of observation area.
This spontaneous report as received from a medical assistant (M.A.) refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of GARDASIL (dose number, dose, route, and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified.   Follow up information was received from the medical assistant  on 06-AUG-2014. The M.A. stated the temperature excursions occurred on two different dates: 10-JUN-2014, 51 degrees Fahrenheit for 51 minutes and on 18-JUL-2014, 48 degrees Fahrenheit for 24-minutes. The M.A. also stated she did not have patient identifiers, lot numbers, expiration dates, or dates of administration available at the time.   Follow up information has been received from M.A.  It was reported that a patient with 14 years old received a dose of GARDASIL with lot # as J09788, exp. date 17-MAR-2016, on 09-JUL-2014.  This is one of several reports received from the same reporter. Additional information is not expected, since all follow ups requested to complete the case were received.
Circular rash, hot and raised and mildly itchy, one week after injextion
Information has been received from a physician concerning a healthy 35 year old female who on 22-SEP-2006 was vaccinated with Varivax following negative VZV serology for her "green card". On approximately 02-OCT-2006, 10-14 days after vaccination, the patient developed varicella. The lesions were all papules and there would not be a specimen for further testing. Additional information has been requested.
Very red 1" diameter hot to touch very sore. Lasted 5-6 days.
Immediately after vaccine, L arm was in pain, 2 days after vaccine, she begin to have a swollen neck on left side and L arm pits. She had a doctors visit on 04/15/2021, no prescription but she has been taking advil 200 2 tabs, 2x daily every 8 hrs. RN recommendation. She is no longer having any swelling or pain. She asked if she should receive the second dose, RN states yes. Her adverse reaction was mild with no respiratory issues. The benefits of her second dose outweighs the possible adverse reaction. Patient is agreeable.
I had the shots and got them agaiin/Suspected vaccination failure; Got them agaiin; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingles vaccine and Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient had the Shingles shots and got shingles again. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
P/flu shot on 2OCT91 severe cold 3 days later; diarrhea & flu 2 wks p/shot; h/a w/fever not usually present; congestion in chest, mild cough, & sore or raw throat; elbows hurt; sick & bedridden most of 6 wks;
Fever onset by 12am 1/23/22 lasting 3 days at 101 degrees. Joint pain in all joints onset 3am 1/23/22. Pain severe (7/10) by 6am 1/23/22 lasting until 1/25/22 at 12pm. Hands began burning and tingling by 8am 1/23/22, lasting 24 hours. Skin on hands changing colors from red to purple to blue to white began 12pm 12/23/22 and lasted 24 hours.