chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse regarding an unspecified patients of unknown age and genders. The patients' medical history or concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # L042257, expiration date 17-AUG-2018; lot # L038501, expiration date 16-AUG-2018; route of administration, anatomical location and dose were not provided). Concomitant medications were not provided. There were no adverse effects reported. Temperature and time were reported as 0 degrees C for 160 hours. Previous temperature excursion was reported as 9C for 10 hours and 30 minutes. This is one of several reports from the same source (MARRS #1604USA017128, 1604USA017913 and 1604USA017914). Additional information has been requested.
Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022; Received the Moderna Covid 19 vaccine after manufacturer date of expiry; second dose was adminstered after 2 months 25 day; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine after manufacturer date of expiry), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was adminstered after 2 months 25 day) and PRODUCT STORAGE ERROR (Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch nos. 027L21A and 083J21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy (Azithromycin allergy), Drug allergy (Amoxicillin allergy), Drug allergy (Codeine allergy), Drug allergy (Promethazine allergy), Drug allergy (sulfa allergy), Iodine contrast media allergy (intravenous pyelogram (IVP) dye allergy), Drug allergy (Keflex allergy) and Allergy to NSAIDs.   On 22-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-May-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine after manufacturer date of expiry) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was adminstered after 2 months 25 day). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine after manufacturer date of expiry), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was adminstered after 2 months 25 day) and PRODUCT STORAGE ERROR (Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative, Patient was not positive for covid-19.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. Number of doses/vials were 26 doses.  The reporter reported that, found out that the vaccine had been expired for 2 weeks and the expiration date was not written on the vial and did not noticed it had already expired.  The vaccine stored in fridge on 17-May-2022.  The vials did not undergo any temperature excursion.  No treatment medications was provided by the reporter.
Patient received COVID vaccine at 2:28 and while waiting in lobby around 2:43 was awake but unresponsive. Patient developed facial swelling and pulse ox was 85. Code Blue called and ambulance called; patient brought into room. NP arrived to assist in Code. 4L oxygen placed on patient and epinephrine 0.3mg given at 2:45p. Patient's facial swelling subsided. EMT arrived around 3:05p and took patient to LMH.
Dizziness, nausea, vomiting starting 4-5 hrs after shot and lasting for several days.  On 8/21/09, orthostatic hypotension noted, temp 99.2.  Viral illness suspected.
Mother reports "high fever" and started wheezing that night within several hours of administration of 2nd set of infant vaccines on 7/24/09
Required a blood transfusion; This case was reported by a pharmacist via call center representative and described the occurrence of blood transfusion in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 9AB33, expiry date 6th December 2021) for prophylaxis.   On 17th September 2019, the patient received the 1st dose of Shingrix. On 3rd October 2019, 16 days after receiving Shingrix, the patient experienced blood transfusion. On an unknown date, the outcome of the blood transfusion was unknown.   It was unknown if the reporter considered the blood transfusion to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On 3rd October 2019, the patient received three pints of blood. The reporter consented to follow up.
2:00am. Chills started first. Then chills got so bad I started shaking uncontrollably almost like seizures. I used slow breathing methods to try to reduce my shaking. I used an extra large heating pad with 4 blankets but could not get my body warm. I felt like i was suffering from hypothermia. I moved my heating pad around to large body parts to try to warm individual body parts to  slow my severe shaking.  My  severe shaking and extreme chills  went on for at least 4 hours. I felt nauseous and felt like I might vomit. I got in shower at 6;30 am to get into a hot shower. I could not lift my left leg without extreme pain in my lower left back. The pain in my back then moved to my hips, then my upper right side. I had diarrhea for 2 days and indigestion after eating small bits of food.   I took Tylenol gel caps on Sunday morning with a full glass of water and went to sleep at 10:00 am. I woke up with my hip joints and left ear pain.
Vaccinated pt admitted with covid infection. No info on vaccine, date, time, manufacturer, etc.
This case was reported by a healthcare professional and described the occurrence of allergy attack possibly due to latex (allergic reaction) in a subject of unspecified age and gender who was vaccinated with hepatitis A vaccine inactivated (Havrix) for prophylaxis. The healthcare professional reported that, some subjects experience an allergy attack possibly due to latex following the receipt of Havrix, however, subject identifiers were not provided. The healthcare professional reported that the subject, Had previously been established as being allergic to latex before the vaccine was administered. On an unspecified date on or before 9/26/2005, the subject received a dose of Havrix, in the 1440 EU, single dose prefilled syringe (dose number and lot number not provided). At an unspecified time after vaccination with Havrix, on an unspecified date on or before 9/26/2005, the subject experienced an allergic reaction to latex in the prefilled syringe. The outcome of the allergic reaction was not reported. The healthcare professional considered the allergic reaction to probably be related to vaccination with Havrix.
pt devel siolated right 12th nerve pasly 7 days p/vax;60 day follow-up dated 9/22/00 provided no additional data. Annual follow-up dated 1/12/01 states the pt's symptoms have resolved.
Patient presented to the Emergency Department of our hospital with report of nausea, vomiting, fever and chills after receiving  a COVID-19 vaccination at the local Health Center.  Specific information  regarding the vaccine (lot number, vaccination site, etc.) is not available to me at the time of this report as the vaccination was not administered by our organization.
breakthrough infections; breakthrough infections; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in Mar2021 as dose 2, single (Batch/Lot number: unknown) and in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "breakthrough infections". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive; (Oct2022) Positive; (Dec2022) Positive.  Clinical course: The patient reported that the patient was fully vaccinated with Pfizer's Covid vaccine, including the inital series in Mar2021 (unspecified date), booster in Sep2021 (unspecified date), and updated (new variant) booster in Sep2022 (unspecified date). The patient work in clinical research and was not sure if the data of breakthrough infections would be liked, as the patient had then tested positive in three separate infections on May2022 (unspecified date), on Oct2022 (unspecified date) and on Dec2022 (unspecified date).  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
pt recv vax 16OCT95 & 15JUN96 pt devel a typical chickenpox rash w/vesicular, erythematous lesions, subsequently pt recovered;
I have been having heart palpitations and my bladder has dropped to vaginal opening which has cause urinary incontinence. These symptoms have been present since my second Pfizer covid vaccine.
Next day after vax always break out/hives/humbs regardless of vaccine, especially on upper part of arm and last for about a week. Benadryl is used to control itchiness so that bumps are not squashed by child.
pt found dead @ home; suspected time of death 230AM-8AM on 3APR93; autopsy performed suspected SIDS death; according to funeral director mom states pt was fine when went to sleep;
Tachycardia, Palpitations, hair loss, muscle spasms/ muscle twitching. Inability to exercise. Major heart pain, cannot live my normal life anymore even on heart meds.
Patient's girlfriend called pharmacy 8/13. She said patient got Moderna 8/5/21. That evening, he had a sore arm. Over the weekend, he then could not raise his arm and could not move wrist or fingers. He took Ibuprofen with some relief. However, today he is in excruciating pain. She said he cannot even put a shirt on. He was advised to seek medical attention
30 minutes post vaccination c/o nausea & vomited X3, feels "hot & cold", ache & burn at injection site. Reports had fever for 2 days, states sore throat and stuffy nose continues at day 6 postvaccination.
severe dizziness; I fainted a couple of times, threw up and continue to feel dizzy when trying to move.  In addition, fever 101, chills, muscle aches, neck stiffness, headache, dry throat, pain around my ears and teeth.  It's been 36 hours since the onset of symptoms, 24 hours of dizziness and it's still continuing. I still can't move without getting dizzy.
temperature excursion for MMR II and VARN AX reporting that those to had been administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 28-SEP-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot number T010380, expiration date: 24-MAR-2022 (lot number T010380 is an invalid lot number for varicella virus vaccine live (oka/merck)), lot number: S015460, expiration date: 20-MAY-2021 (dose and route of administration were not reported) or measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot number: S029455, expiration date: 19-SEP-2021, therapy type: rHA; lot number: S001338, expiration date: 14-JAN-2021, therapy type: rha (dose and route of administration were not reported) for prophylaxis. The reporter did not provide which vaccine the patient received.  It was reported that the vaccines were not stored properly for the time frame of 15 minutes in the temperature between 15 degrees Fahrenheit (F) and 46 degrees Fahrenheit (23.9 F). There was no previous temperature excursion for both vaccines. Digital Data Logger was involved.  The outcome of medication error was unknown.
ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXIA ANGIOEDEMA, INIT ANGIOEDEMA, SEQUELA ALLERGIC REACTION, INIT 11/8/2022 &  11/21/2022  --  RECURRENCE OF SAME SYMPTOMS
3 day headache, dehydration (slight kidney issue), swollen left eyelid and left gland (behind ear), rash on forehead
fainted after the first shot and fell down face forward and busted her lip; fainted after the first shot and fell down face forward and busted her lip; fainted after the first shot and fell down face forward and busted her lip; rash on arms, back and chest; Blurred vision; Joint and muscle pain.; Joint and muscle pain; Weak and having to walk with a cane.; This is a spontaneous report from a contactable consumer(patient). A 68 years old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The medical history and concomitant medications were not reported. The patient was having some symptoms and she need to talk to someone about what to do about them. She had nausea and diarrhea, severe pain in her abdomen feeling like a knife stabbing her mostly left side. It was excruciating. She got the second vaccine yesterday and all the above events started last night. She had chills, headache, mental clarity and can't think straight and weak after the second dose. She fainted after the first shot and fell down face forward and busted her lip. She had quite a few side effects. Blurred vision, rash on arms, back and chest. Joint and muscle pain. Weak and having to walk with a cane. The outcome of the events was unknown.  No follow-up attempts are possible; information about batch number cannot be obtained.
the patient reported Gland Inflammation By Breast on Left side of Body. The Vaccine was Given in Left Deltoid.
This spontaneous report as received from a registered nurse refers to 5 unspecified patients of unknown age and gender. No concurrent conditions or medical history were reported. The nurse reported that, on an unknown date, the patients were vaccinated with improperly stored doses of VAQTA (lot number, expiration date and route were not reported). No concomitant medications were reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
In May, 5 months after my 2nd dose I had an extreme heavy menstrual bleeding episode that landed me in the ER. I had abnormality in my von willebrand's electrophoresis. After some retrospective investigation, we thought it was related to acupuncture/use of Chinese herbs. Followed up with a hematologist who stated that my labs were normal. I just got my booster dose on 11/12 and on 11/17 I had spotting about a week earlier than anticipated. My period returned on 11/19 and I had a couple days of extremely heavy bleeding again (soaking tampons within an hour) and extreme cramping. My period is still present with a moderate flow today on 11/28/21. I am not sure if it is related but since my period had regulated for a few months and then is abnormal again within a week of receiving my vaccine I thought I should report it in case it is related. I also did have a lump and red rash on arm that appeared with my booster that I did not have with my first two doses.
No fever, felt as though I was getting a cold or lite case of the flu . No. energy lasted 2 weeks. On Monday of the second week I went to an urgent care. Was tested for COVID and two kinds of flu. All negative. Was told I would have just wear the virus out at home. This same thing happened again in late May. Then in August 27 I had chills and aching that nite . Went back to urgent care was test for COVID , rapid and mail in both were negative. Test for two kinds of Flu both were negative. Feel all right today
APPROXIMATELY 10 MINUTES AFTER RECEIVING THE SHOT THE PATIENT BEGAN TO FEEL FAINT.  HE QUICKLY PROGRESSED TO BECOME DISPONDENT, COLD TO THE TOUCH, WEAK, SWEATING PROFUSELY, AND FACE WAS PALE.  AFTER LYING DOWN HE BEGAN TO REGAIN HIS COLOR AND BECAME MORE COHERENT.  PARAMEDICS ARRIVED AND CHECKED HIM AND ALL VITALS WERE OK AT THAT POINT.
PENTACEL ordered, staff was interrupted while preparing vaccine. Staff mixed PENTACEL powder with sterile water and not mixed with DTAP/IPV. During the double check with another staff member, error was caught before reaching the patient.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6202), in left arm, on 18Mar2021 as dose 2, single (Lot number: EN6204), in left arm and on 24Sep2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild emphysema" (unspecified if ongoing), notes: Mild emphysema; "Lobectomy" (unspecified if ongoing), notes: Lobectomy; "Known allergies: Pineapple" (unspecified if ongoing), notes: Known allergies: Pineapple. Concomitant medication(s) included: VITAMIN D3, start date: 06Jun2019, stop date: 12May2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11May2022) Positive, notes: Initially tested positive for COVID on 11May2022; (20May2022) Negative, notes: Finally had tested negative; (24May2022) Positive, notes: I again tested positive for COVID. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Treatment start date was 11May2022 and stop date was 17May2022.  7 days after her last dose of Paxlovid (17May2022), and 3/4 days after she finally had tested negative (20May) she again tested positive for COVID on 24May2022. (Initially tested positive for COVID on 11May2022, and started Paxlovid the evening of 12May2022). Report about COVID treatment: Yes. The patient received Other medication in 2weeks is reported as Yes.
Rash, swollen joints, irritability occurred 2 days after receiving vaccines. Patient was also on day 6 of amoxicillin. Patient received prednisolone, ZYRTEC, BENADRYL & MOTRIN.
She has soft stools; Hair thinning; Kidney pain; Sore hip and back; Sore hip and back; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot Number unknown, expiration date unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history included Covid-19. The patient concomitant medications were not reported. The patient experiencing has soft stools, hair thinning and had kidney pain, sore hip and back. The outcome of events was unknown.  Information about lot/batch number is requested.
Patient returned to pharmacy 3/4/2019, reported passing out about 4 hours following administration of SHINGRIX. Patient was alone at the time, but reported "coming out of it" quickly. Patient returned home and went to bed. She reported chills and fever that continued for 2 days.
Fever of 100 4 days post booster dose; lasted 24 hrs; local rxn characterized by pain, redness, swelling, warmth & itchiness x 24-72 hrs p/inject;
Headache, fever, body aches, left arm very sore, slight nausea since the first evening Monday.  Today is Wednesday and I am hoping this will all clear up soon.
4/3/23 I started developing a chest cold, deep congestion. It has lingered to this day. I went to my PCP on 4/19/23, he confirmed it was not pneumonia and that there was a respiratory virus going around. He did not think it was bacterial but prescribed an antibiotic just in case. I started taking the antibiotic because my phlegm turned to a green color. My doctor also suggested ROBITUSSIN DM for my cough.
This spontaneous report was received from a registered nurse (R.N.) via telephone call on 20-OCT-2015, concerning a 5 year old patient of unknown gender. No concurrent conditions or medical history were reported. On 01-SEP-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L002242 Expiration date: not reported) (dose, route and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot#J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck. Follow up information has been received from the registered nurse who provided patients details. This report refers to a 9 weeks old infant patient of unknown gender. On 02-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot#J016188, expiration date 02-OCT-2014) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Acute Pericarditis without tamponade. Onset within days of vaccine administration. Presented to the ED after eight days of symptoms. Was prescribed colchicine and ibuprofen. Left hospital day 2 in good condition with improving but not resolved chest pain. Unknown subsequent
11/27/2006 Patient noticed pain in her left arm/ shoulder that has not resolved since injection.  on 1/21/09 she saw Dr who has noticed inflammation which is now being treated.
pt fussy noc of vax & did not sleep well that noc;pt fussy the next day;low grade fever; APAP & got a decongestant from MD:some forceful vomiting;was listless & not responding well;adm to hosp;dx strep pneumonia, meningitis;sz
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose01/07/21 2nd dose01/28/21 Diagnosed covid positive:09/08/2021 Symptom onset:09/06/21 Exposure: Symptoms:cough, fatigue,muscle aches,sore throat,diarrhea,chills HA
Patient vaccinated with Pfizer vaccine mixed with sterile water instead of 09% Normal Saline, preservative free. Consulted with CDC to determine next steps for patient after discovery. Re-vaccination advised and outreach team contacting impacted patient and offering to speak with a physician to discuss.