chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant referring to a 14 year old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (manufacturer unknown). On 13-MAR-2018, the patient was administered an improperly stored GARDASIL 9 (lot: N026814; Expiry date: 15-JUL-2020 and lot reported as "N021572"; Expiry date: 01-MAY-2020) reconstituted with a properly stored sterile diluent (lot and expiry date not reported) for prophylaxis. The vaccine was exposed to 47 °F to 77°F (67.3°F) for 10 hours, 30 minutes. There was no previous temperature excursion. There was no involvement of digital data logger. This is one of the several reports linked via same reporter link.
Pt experienced vomiting and diarrhea for two days following the last two vaccines. The pt reportedly recovered.
I21.4 ACUTE NON ST ELEVATION MI 6/15/2022 ABDOMINAL PAIN I21.4 ACUTE NON ST ELEVATION MI 6/15/2022 ATRIAL FIBRILLATION, PAROXYSMAL
11AM pt recvd vax; 1130AM crying excessively  up to 2 hrs periods w/only 10-20 minutes w/no crying lasted over 24 hrs; site redness; no swelling; cried w/movement of rt leg; appetite dec ate & nursed only 1/2 of usual; t101;
My entire arm from the middle of my neck (C3) to the tips of my fingers and into my chest and back sternum to spine down to about T7 felt extremely tender like I had shut it in a door, and I couldn't put pressure on my hand without shooting pains up into my neck, and movement also caused pain it lasted until about 4pm and then it is still a little sore now and it is 12-07-10 but the real pain is gone. I couldn't work on Sunday and had to call out.
Tested positivev 8/10/22 and then tested positive again 9/5/22 prior to admission for post partum pelvic pain. Current hospitalization not related to COVID.
Information has been received from a Licensed Visiting Nurse (L.V.N.) for GARDASIL, a Pregnancy Registry product, concerning a 24 year old female with no medical history or drug allergies who on 23-FEB-2010 was vaccinated intramuscularly with a dose of GARDASIL (lot# 663558/0819Y). Concomitant therapy included TYLENOL. On 23-FEB-2010 the patient came into the office to get some lab exams and a pregnancy test. GARDASIL was ordered and given before the pregnancy result returned positive (about 7 weeks pregnancy). No adverse event occurred. It was unspecified if the patient sought medical attention. Follow-up information has been received from the L.V.N. via a voice mail reporting the patient had an "elective termination" on an unspecified date. Upon internal review, an "elective termination" was determined to be an other important medical event. Additional information is not expected.
Vaccine administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thaw process) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030h21b) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient age was reported as 57 years 6 months.  No concomitant medications was reported. The patient did not had any adverse reactions and no reports of any reactions after the administration of the vaccine. Vaccine Ndc Code was reported as 80777-0273-99. No treatment medications was reported.
Swollen lip; Hives near the groin area; This is a spontaneous report from a contactable consumer (patient's daughter).  An 82-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3246), via an unknown route of administration, at single dose on 12Jan2021 for COVID-19 immunisation. Relevant medical history included gout and sinuses. The patient did not have relevant concomitant medications.On 12Jan2021, after vaccination, the patient had swollen lips and he thinks like hives on his thought near his groin, on the upper inside of his thighs on both sides, like hives, with swelling but not a rash. She said her father put hydrocortisone cream on his thighs and they were getting better. She said the lip swelling had not gone down, he took an allergy pill for that, he did not apply cream to his lips. She clarified that the hydrocortisone cream was brand Equate 1% Hyrdocortisone Maximum Strength Cream (UPC 319162ET4, Batch: 8JT0419, and EXP Aug2021). She reported that the allergy pill was generic Equate Allergy Relief (UPC: Unknown, LOT P121359, EXP Aug2022). The patient was recovering from the events.
Patient had a history of bad vaccine reactions therefore was monitored for 30 minutes for possible anaphylaxis. No anaphylaxis occurred during that period. After the vaccinator dismissed the patient from observation shortly thereafter the patient developed itchiness. The patient then proceeded to purchase Zyrtec to treat the condition of her own regard. She took 3 doses daily through Sunday.(Friday = dose 1, Sunday = dose 3). The itchiness went away by Sunday evening but then the patient woke up on Monday and had visible hives on the left side of her head all the way extending to her neck. She also had a hive along her temple/hairline on the right side. She reported this to the employee health department of the hospital who advised her to speak with her PCP at the time.
45 yo F with history of strial fibrillation and anxiety, who had elevated HR as high as 160s felt like her atrial fibrillation. Started right after her vaccine was given, felt a little anxious then her HR increased. She took her home Metoprolol (which she uses as needed for her afib). Nurse observed her for 30 minutes prior to my eval, HR now normalized to 80s-90s. BP  105/78, SaO2 99%. Pt asymptomatic at this time, states she is feeling better. Offered ED visit, but states she would rather follow-up with her cardiologist, has his phone number and will call him today.
the blood pressure goes high and low al day long; the pulse and the blood presure goes high and low all day along; some fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE FLUCTUATION (the blood pressure goes high and low al day long), HEART RATE IRREGULAR (the pulse and the blood presure goes high and low all day along) and FATIGUE (some fatigue) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disease, unspecified.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE FLUCTUATION (the blood pressure goes high and low al day long), HEART RATE IRREGULAR (the pulse and the blood presure goes high and low all day along) and FATIGUE (some fatigue). At the time of the report, BLOOD PRESSURE FLUCTUATION (the blood pressure goes high and low al day long), HEART RATE IRREGULAR (the pulse and the blood presure goes high and low all day along) and FATIGUE (some fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment information was reported.  Patient reported- No pain no discomfort no breathing issues.
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 (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster, sickness, pain, pruritus and eye disorder. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the herpes zoster was recovering/resolving and the outcome of the sickness, pain, pruritus and eye disorder were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, herpes zoster, sickness, pain, pruritus and eye disorder to be related to Shingrix. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient experienced a severe case trigeminal herpes zoster. It had been six weeks and was still quite sick with a lot of pain and itching. The patient stated that eye was a disaster. The patient asked if what was the point of getting the vaccine and why did he/she got the trigeminal herpes zoster even after he/she had the vaccine. At the time of reporting the patient was recovering from a severe case trigeminal herpes zoster. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
First day general sick feeling, muscle aches, sore throat, tired. Second day comes in waves...terrible stomach and body aches, on fire with no temp, racing heart over 125, heavy legs and feeling like unable to move. 4 episodes lasting 1 hour each.
tested positive for Sars-Cov-2; tested positive for Sars-Cov-2; This is a spontaneous report from a contactable consumer (Patient) reported for himself. via Pfizer-sponsored program. A male patient of an unspecified age received first dose of bnt162b2 (Pfizer-Biontech covid-19 vaccine, Formulation: solution for injection, Lot number: unknown, Expiry date: unknown), via an unspecified route of administration on 31Mar2021 as single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 16Apr2021(Last Friday), the patient tested positive for sars-cov-2. He called into ask if he can go ahead and get the second dose of the vaccine due on 20Apr2021. On 16Apr2021, the patient underwent lab tests and procedures which included sars-cov-2 test: positive. The events were considered as serious. The outcome of the events was reported as unknown.  Follow-up (18Apr2021): This is a Follow-up spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that.  Information about Batch/Lot number has been requested.
Approximately 8-12 hour following receipt of vaccine, felt nauseated, dizzy, feverish and experienced vomiting, diarrhea and abdominal cramping. After anthrax vaccine #3 on 8/7/03; experienced same symptoms within 8-12 hours, admitted on 8/8/03 for 1.5 days (no records available. ) See attached clinical study.
vaccine site rt deltoid redness w/inc itching-area about size of half dollar-ice applied;
RASH ON HANDS< AND OVER FOURTY PERCENT OF BODY AFTER VACCINE>>NOW HAVE GUILLIAN BARRE SYNDROME> 12/13/09-office notes received for DOS 11/21/06-well visit-mild acne-received 1st Gardasil vaccine. Office visit 2/6/07-C/O scleral icterrus past few weeks, comes and goes 2nd Gardasil vaccine. Office visit 7/31/07-2 episodes of syncope in last few days, fluid intake decreaed. Dizziness. Office visit 7/23/08-well visit. Office visit 8/1/08-dizziness, blood pressure standing 104/54, blood pressure lying 120/58. DX: Orthostatic hypotesion. Plan increase fluids. Office visi 12/30/08-C/O back pain, involved in an auto collision. No significant injury.
Jan 12, 11:30am - Dizziness, headache, muscle aches, weakness, cold feeling, flushed. Temperature = 102.4 F.  Had to leave work.  Slept for 18 hours, Symptoms continued for 48 hours.
Since taking the vaccine, patient has felt very weak and tired cant do anything during the day; Since taking the vaccine, patient has felt very weak and tired cant do anything during the day, Cant shake the tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Since taking the vaccine, patient has felt very weak and tired cant do anything during the day) and FATIGUE (Since taking the vaccine, patient has felt very weak and tired cant do anything during the day, Cant shake the tiredness   ) in a 71-year-old female 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Since taking the vaccine, patient has felt very weak and tired cant do anything during the day) and FATIGUE (Since taking the vaccine, patient has felt very weak and tired cant do anything during the day, Cant shake the tiredness   ). At the time of the report, ASTHENIA (Since taking the vaccine, patient has felt very weak and tired cant do anything during the day) and FATIGUE (Since taking the vaccine, patient has felt very weak and tired cant do anything during the day, Cant shake the tiredness   ) had not resolved.            No relevant concomitant medications were reported.  No treatment information was provided.
Tinnitus  and  feeling of ear being blocked mostly in left ear.   COVID  arm
Patient was feeling dizzy, turned pale and had a blank stare for a couple minutes. Patient was kept and monitored for 45 minutes in the office. Apple juice was given before the vaccine. BP was taken 4 times before discharged. Doctor's kept monitoring the patient.
12/30/20 dose 1 2:30am: extreme night sweats, entire body was drenched. Had to wipe chest off with a towel. Also had chills. The soreness pain in my left arm was so severe Everytime I moved it while asleep it woke me up. 6:30am: 101.7 fever, chills, body aches. I could not life my arm above shoulder height ALL day.  10:00am: fatigue and joint pain in my sacrum and across to hips, down my legs, into my knees, and sometimes my shin. (This was the worst symptom).  Experienced all the above symptoms all day. Still had a fever over 101.  2:00pm took advil and fell asleep for the hours. When I woke up, the body aches and joint pain was gone.  6:30pm chills came back and get off 99.9 and Loss of appetite for dinner No fever or side effects the next day when I woke up.  1/27/21 dose 2 7:40am received vaccine dose 2 10:00am arm soreness at site injection began and progressively grew worse throughout the day but not nearly as bad as the first dose.  4:15pm chills began 5:40pm 99.8 fever 6:20pm mild body aches in neck, between shoulder blades. Still had mild chills. 8:00pm 101.2 fever Took an advil and all side effects resolved 1/28/21 Just fatigue, no other side effects.
Two months after vaccination I started to get severe diarrhea (5-6 times per day) for 3 days. Two days after the diarrhea started I got a throbbing pain shooting up my left arm to my shoulder.  The pain was significant enough that it made me nauseous.   Soon after the pain started in my left arm I had chest pain/tightness.  When I went to standup I nearly passed out.    The symptoms subsided after ~1 week
must have hit a nerve with the first dose; Pain in left arm/radiating pain; carpal tunnel; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), patient's wife.  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Oct2021 (Lot number: FF2593) at the age of 43 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Reporter denied any other medications, medical conditions, labs, testing, or treatments for the patient relevant to the events. There were no concomitant medications. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). Reporter referred to Pfizer Covid Vaccine as "Toxic Poison." The patient got the first dose in his left arm and had pain in his arm. Within 4 days, he had radiating pain. He let it go and then eventually was seen and was told it was carpal tunnel. He was given a brace and sent on his way. When he went back for the second dose he told the people at the site about the pain in his arm and they told him that they must have hit a nerve with the first dose. The patient went to a city run site on purpose for the vaccine because there was medical staff there.  The following information was reported: PERIPHERAL NERVE INJURY (medically significant) with onset 26Oct2021, outcome "unknown", described as "must have hit a nerve with the first dose"; PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "unknown", described as "Pain in left arm/radiating pain"; CARPAL TUNNEL SYNDROME (non-serious) with onset 2021, outcome "unknown", described as "carpal tunnel". Therapeutic measures were taken as a result of carpal tunnel syndrome. Follow-up attempts are completed. No further information is expected.
PT came into the pharmacy to report that since she received her first Moderna Covid vaccination she has had a large red, raised rash on her left arm at the injection site.  It was about the size of an orange at the time of her visit but she stated that it had been larger.  Other than the large rash she had been feeling unusually tired and fatigued.  She had also noticed a headache and nausea that had been almost constant since her first dose.
pt began to feel tingling in her left arm and her throat. she felt tightness in the throat and voice was hoarse. she felt ligh headed like she might pass out but did not pass out. she felt chest discomfort with deep breath.
Patient presents to the emergency department on 8/10/22 for evaluation of diarrhea that has been going on for over 1 to 2 months.  She states that it happens several times throughout the day and she is unable to control it.  She lives in a center where everybody has been sick and coughing and she states she has been coughing so hard that she will have stool incontinence. She tested positive for COVID on 8/10/22.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and referred to a currently 79 years old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unspecified date 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, dose number and route not specified) for long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Nurse calling to report administration of expired vaccine MMR II; No additional adverse events reported as a result of the administration of the  expired vaccine; This spontaneous report was received from a Nurse referring to a patient 18-months-old , unknown gender, Information regarding the patient`s pertinent medical history, current condition, drug reactions/allergies and concomitant medication was not provided.   On 26-MAR-2021, the patient was vaccinated with a expired Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II), lot number S007813 and expiration date 14-MAR-2021 0.5 ml (single dose),for prophylaxis,(vaccination scheme and anatomical location were not provide)  No additional adverse events were reported as result of the vaccine administration. No prior temperature excursions were reported for the suspect therapy.
The most concerning was hallucinations.  I saw the tooth fairy and cried for santa.  I had a fever, chills so violent that I made the bed shake - lasted for hours; severe headache that triggered a migraine, exhaustion, and nausea.  It's 2 days later and I still feel terrible.  My husband gave me a tylenol PM that night and the next day as the headache was a full blown migraine, I took naratriptain.   I still have a slight headache but want to avoid taking additional medicine if possible.
Small area of redness at vaccine site two weeks following varivax which was given on 03/02/2002. Also small blister in center of redness.
Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 16-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 16-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 79-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 16-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 16-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 16-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 (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 16-Jul-2022).    Concomitant product was not provided. Treatment information was not provided.  Patient received half dose.  On 04-Jun-2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions.
Increased swelling, redness on right thigh, injection site, 2 hours after shot.
Patient reported Hives and tingling in neck. Reaction worsening with continued hives and feeling of throat thickening up, and tingling tongue. Patient went to the ER and wad diagnosed with allergic reaction. Patient was given prednisone and diphenhydramine and told to follow up with primary next week.