chrisvoncsefalvay/vaers-outcomes huggingface dataset:
unknown bleeding; nausea; lightheaded; GI bleed; cardiac arrest; bleed in small intestine; This is a spontaneous report from a contactable consumer (patient's daughter). A 70-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Deltoid Right on 26Feb2021 (Batch/Lot Number: EN6198) as SINGLE DOSE for covid-19 immunisation. Vaccine Administered at Military Facility was no. Patient received the first dose of vaccine on 05Feb2021 at age of 70 years old for covid-19 immunization and experienced rash on face, loss of blood found to be from small intestine, hemoglobin low, cardiac arrest, going into shock. The patient medical history and concomitant medications were not reported. The patient experienced unknown bleeding (death, hospitalization, medically significant) on 10Mar2021, nausea (hospitalization) in 2021 with outcome of unknown, lightheaded (hospitalization) in 2021 with outcome of unknown, gastrointestinal (GI) bleed (medically significant) in 2021 with outcome of unknown, cardiac arrest (medically significant) in 2021 with outcome of unknown, bleed in small intestine (medically significant) in 2021 with outcome of unknown. Patient went to the hospital on 10Mar2021 with nausea and lightheaded. Endoscopy found GI bleed in 2021. Received blood went into cardiac arrest. Sent to another hospital found bleed in small intestine. Patient experienced unknown bleeding on 10Mar2021, which required visit to Emergency room/ intensive care unit on 18Mar2021 and received treatment, it resulted in death. The patient died on 18Mar2021. An autopsy was not performed.; Reported Cause(s) of Death: unknown bleeding
possible/suspected pinched nerve, pain may be some sort of compressed nerve; lot of chronic pain; felt lousy; Initial information received on 19-Aug-2020 regarding an unsolicited valid non-serious case received from a consumer (patient).  This case involves an unknown age female patient who experienced lot of chronic pain (pain), possible/suspected pinched nerve, pain may be some sort of compressed nerve(nerve compression) and felt lousy (malaise), while she received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation: Injection, batch number and expiry date: not reported) via an unknown route in the left arm for prophylactic vaccination.  On an unknown date, the patient developed a non-serious lot of chronic pain (pain) possible/suspected pinched nerve, pain may be some sort of compressed nerve (nerve compression) and felt lousy (malaise), two weeks following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of events pain, nerve compression and malaise was not reported.  There will be no information available on the batch number for this case.
Nausea, diarehha, throwing up Have felt sick ever since That will be the last flu shot I ever get.
pt recv vax 21JUN95 & 5FEB97 pt presented to MD office w/clinical varicella that consisted of a rash w/over 30 lesions;had no fever;
This spontaneous report as received from a nurse refers to unknown number of patients of unknown age and gender. No information about medical history, concurrent conditions was reported for the patients. On an unknown date the patients were vaccinated with GARDASIL 9 lot # K026247, expiration date 29-JAN-2017 (dose strength, route unspecified) post temperature excursion with no adverse effects. No product quality complaint was involved. This case is linked to the case via 1509USA001313 same reporter link. Additional information has been requested.
acid reflux- belching, burning in throat  I have also put on weight, 30 pounds, since last September which likely influenced the acid reflux,  treated with famotidine 40 mg-symptoms are mostly resolved, currently working to reduce weight with diet and exercise
Significant chest pain and heart palpitations. Took ibuprofen and rest, however symptoms persist after more than a week after.
pt c/o sore arm next AM;devel fever as day progressed >10 days which resolved 26JUL98;awoke 26JUL98 w/mult rash on lower extremities spreading to upper extremities;ER MD stated probably d/t Td vax;
Left deltoid area swollen, red and hot. Pt was given Amox, Antipyrine/Benzocaine and Hydroxyzine.
Herpes Zoster (Shingles) right arm. No recent exposure. Recovery is unknown at this time.
This is a spontaneous report from a contactable consumer (patient) reported for herself. A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/lot number: EN6198, expiration date: Unknown) via an intramuscular route in left deltoid on 24Feb2021 at 09:51 (age at vaccination: 73-year-old), as a single dose for covid-19 immunization (reason: hadn't seen her grandson in over a year). Medical history included low cholesterol and diabetes. Concomitant medications included ramipril 5 mg once per day for blood pressure and diabetes. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no adverse events following prior vaccinations. None, previous immunization with the Pfizer vaccine considered as suspect. When she went to get the vaccine, she was fine. They made her sit for 20 minutes. After receiving the vaccine on 24Feb2021, she sat down for about maybe 30 minutes and when she got up, she noticed she had lightheaded/dizziness. she said she thinks she needed to go to the doctor. She went to doctor that was inside the center, they took her blood pressure, and it was at 172. The doctor was saying she was anxious and that she will be fine. She sat there for a while. After about 15-20 minutes, she thought she's fine, so she got up, and the doctor asked her, if she was sure. Her husband and she walked around to get some air. She thought the dizziness was going to go away, but it's been a week. Up unto this day, she still got dizzy, like a light headedness. She wanted to know if it was going to go away and how long was this going to last. Her blood pressure was consistent sometimes it went to 130-140. Her second COVID 19 vaccine was scheduled for 17Mar2021. The patient underwent lab test and procedure which included blood drawn (blood test unspecified) when she went to the doctor yesterday, she didn't have any results yet and she checked it this morning her blood pressure and it was 128/69. She also went to ophthalmologist to make sure it wasn't her eyes and that was fine. She had not gone to the ED just the doctor because it wasn't really that bad. She's concerned if she's walking down the street. The clinical outcome of the event dizzy was not recovered, high blood pressure was recovered on 24Feb2021 and anxious was unknown. No follow-up attempts are possible; Information about lot/batch number cannot been obtained.
Red, warm, itchy area developed right below vaccination site. Went to oncologist diagnosed w/possible cellulitis. Given KEFLEX, and is monitoring spread. (No decrease in movement).
On  March 19 around 8 pm my lymph nodes under my arm started swelling and were very painful. They stayed like that for for 3 days before starting to go down.. The injection hurt when it was given. The  first dose given in my left arm did not hurt 2/22/202. My lymph nodes in my neck swelled a little, but never caused  pain.  I had a mammogram on 3/18 and a place on my left breast/ lymph node has shown that it  could be malignant , but I have to go for more tests to check it out. I have since read about this happening after the Covid 19  vaccine.  The nurses at hospital said to report things like this since the vaccine is still so new, to help know what is happening. So that?s why wam. Thank you!
immunocompromised patient received half dose as a 3rd dose instead of a full dose.; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised patient received half dose as a 3rd dose instead of a full dose.) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058A27B, 076C21A and 035C21A) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised and Drug allergy (patient had Medications allergy, didn't want to specify which ones.).   On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jun-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jun-2022, the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised patient received half dose as a 3rd dose instead of a full dose.). At the time of the report, ACCIDENTAL UNDERDOSE (immunocompromised patient received half dose as a 3rd dose instead of a full dose.) outcome was unknown. No concomitant medication were reported.   No treatment drug were reported.   Reporter did not allow further contact
On 02/03/21, 22 yo F was seen in clinic for a Nurse Only visit for vaccination.  During this visit, pt was ordered Pneumococcal Polysaccharide 23-Valent (Pneumovax-23). At 1113, CMA administered 0.5 mL IM in left deltoid (Lot #T033369). Pt tolerated injection without incident and pt was discharged in stable condition. On 02/05, pt's mother called the Nurse Triage line and reported pt with fever of 102.2 and redness and pain at injection site. Instructions were given to seek care at ER or Urgent Care clinic. On 02/06, pt was seen at ER. Pt assessment showed elevated white blood cell count and elevation in inflammatory markers. Pt diagnosed with cellulitis of left shoulder. Pt discharged with prescription for doxycycline.
On 11/17/2022 I woke with chills, fever and headache. I took a home test and tested positive for COVID-19. I had a telehealth conference with my Primary Physician and was prescribed Paxlovid. I did not take Paxlovid but I was better after about 3/4 days.I also wanted to note that I tested positive for 11 days since onset.
Sore muscle Left arm-hearing loss left ear, runny nose x 1 month.
The patient had severe shortness of breath resulting in cardiac arrest on the 5th day after the vaccine. Shortness of breath started 12 hours after injection. On the 5th day, the patient was discovered to also have a rash throughout his body, but it is unknown when this rash started.
Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from a other health care professional via phone. This case involves a 17 years old male patient who was vaccinated with a 0.5 ml dose of FLUBLOK QIV (Batch number: QFAA1801, expiration date: 29-May-2019, site of administration: left deltoid and route was not reported) on 18-Sep-2018. The patients medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate age at vaccine administration (FLUBLOK QUADRIVALENT given to 17 year old patient). It was unknown whether patient experienced any adverse event following vaccination. 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. List of documents held by sender: none.
Rash developed (pink, raised welps) post shot. Unsure of exact timeline.
People I know had shingles after vakkkkcinachuns/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis..   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: People I know had shingles after vakkkkcinachuns/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date:09-APR-2023. This serious case was reported by a consumer via interactive digital media. Reporter stated that he/she know that had shingles after following vaccinations. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Pt phone number is disconnected, pt has not come back for any reason. Please contact MA, for any questions. Please and thank you.
Patient received pneumococcal vaccine Dec 12 as an inpatient. He was seen today in outpatient clinic with fevers 102 F in past 24 hours, aches, at vaccine site 10cm erythema, painful to palpation, no induration. Afebrile at appointment. Received Merck Sharp Lot 1169AA left arm Pneumo 23P5 0.5ml.
rash on arm appeared 7-8 days post vaccination.  It was "hot and burning" also itchy.  Pt used Benadryl and cortisone2.5%.. burning went away but still itchy and still has rash.  Patient feels that Benadryl did not help.  Pt was told by health care professional to monitor and if she has trouble breathing to go to ER.
Received 0.25 ml for 2nd dose of Moderna COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml for 2nd dose of Moderna COVID-19 vaccine) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 03-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml for 2nd dose of Moderna COVID-19 vaccine). On 03-Dec-2021, ACCIDENTAL UNDERDOSE (Received 0.25 ml for 2nd dose of Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.
spontaneous bleed; bruise on the shin; sore arm; hives; nose bleed; A spontaneous report was received from a consumer, concerning a 69 years-old female patient, who received Moderna's COVID-19 vaccine and experienced sore arm, hives, nose bleed, spontaneous bleed, and bruise on the shin.    The patient's medical history included Von Willebrand Disease and breast cancer. Concomitant product use was not provided by the reporter.  On 19 JAN 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number 012L20A) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date post-vaccination, the patient experienced a sore arm and some hives. Approximately two weeks after the first dose, the patient experienced a spontaneous bleed resulting in a huge bruise on the shin the size of the palm of their hand. The patient consulted their Hematologist who performed blood work which was perfect. There were no abnormal results. The physician administered DDAVP.  On 09 Feb 2021, the patient experienced their first nose bleed described as "horrific".  The patient reported they had blood gushing out of their nose and that they bled for four hours. The patient ended up in the hospital emergency department where they were sprayed with DDAVP to stop the bleeding.  Treatment details included DDAVP.  There was no change planned to the dosing schedule of mRNA-1273 in response to the events.  The events, nose bleed and spontaneous bleed were considered not recovered / not resolved.  The outcome of the events sore arm, hives, and bruise on the shin was unknown.; Reporter's Comments: Based on the information provided and the patient's history of Von Willebrand Disease, a causal association between the events nose bleed, spontaneous bleed, and bruise on the shin with mRNA-1273 use is assessed as unlikely.  However, based on temporal association, causality for the events of sore arm and hives cannot be excluded.
35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication information was reported.  No Treatment medications were provided.  The Nurse is providing information for 35 patients. A vial at their clinic was punctured 30 times. 10 patients were affected. Given the process in place at the vaccination clinic it is not possible to identify the 10 patients who received the compromised vaccine.  It was reported that all doses given are booster doses.
Patient was to receive Pfizer Covid-19 12+ as his second dose.   Instead, he was given the Updated Bivalent Booster.  His mother stated he has had no adverse reactions, and she would keep an eye on him over the next few days.  If any occur, she will contact his physician and our facility to make us aware.
Flu-like symptoms to include fever, malaise, and body aches. Individual took ibuprofen OTC when symptoms began.
I noticed after I got out of the shower around 10 pm the day of my 2nd dose I had a rash on the top of my right shoulder across my chest and collarbone and up the sides of my neck. The rash did not itch or hurt and was gone the next day. I also started my menstrual cycle the day after my shot and have been bleeding very heavily for 3 days (Sunday, Monday and Tuesday 9/12-9/14. not showing signs of letting up.
PATIENT FELT EXHAUSTED AND SLEPT FOR 2 DAYS.  WAKING TO EAT AROUND 8:00 PM.  FELT BAD IN HIS BODY, DESCRIBED AS LIKE A HANG OVER AFTER DRINKING.  BUT HE DOES NOT DRINK.  COULD NOT MOVE AROUND.
Information has been received from a medical assistant concerning to 5 patients (ages and genders not reported) who on an unknown date were vaccinated with improperly stored doses of GARDASIL 9 (Lot No. N017697, exp date 21-JAN-2020) for prophylaxis. No adverse events reported. The call was made due to a digital data logger. The vaccine was exposed to a temperature of 50.5 degrees Fahrenheit for a time frame of 1.5 hours. There was no previous temperature excursion involved. Follow-up information was received from medical assistant on 03-NOV-2017. On 27-SEP-2017, a 15 year old male patient was vaccinated with GARDASIL 9 from lot N015087 expiry date 20-OCT-2019 by intramuscular route for prophylaxis. No adverse events reported. This is one of the several reports linked via same reporter link.
patient states that she had flu like symptoms for 3 days. she also said her arm had a knot the size of a tennis ball
Allergy; Initial information was received on 19-May-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and gender patient who experienced allergy after receiving DIPHTHERIA, TETANUS and not otherwise specified PERTUSSIS VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA, TETANUS and not otherwise specified PERTUSSIS VACCINE produced by unknown manufacturer (unknown formulation) (lot number, expiry date, strength, was unknown) via unknown route in unknown administration site for prophylactic vaccination (Immunization). The information on the batch number was requested.  On an unknown date the patient had allergy (hypersensitivity) (unknown latency) following the administration of DIPHTHERIA and TETANUS and not otherwise specified PERTUSSIS VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Information has been received from a registered nurse refers to a 9 month old patient. In DEC-2014 the 9 month old patient was vaccinated with VAQTA, injection, strength 25/0.5 (unit unspecified), (lot#, dose and route not reported); which was coded as "Inappropriate schedule of vaccine administered". No adverse effect was reported. Additional information has been requested.
The patient stated she felt soreness at injection site on Monday, 01/16/2017, morning and noticed a little redness as well. She went to her prescriber, and he instructed her to take some Benadryl.
Blood glucose reading of over 300; Shacking palms; Sweaty palms; This case was reported by a pharmacist via call center representative and described the occurrence of blood glucose increased in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 2G2T7, expiry date 15th November 2021) for prophylaxis.   Concurrent medical conditions included diabetes (was a diabetic so they monitor their blood sugar).   On 13th September 2019 10:16, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 13th September 2019 03:05, 4 hrs 49 min after receiving Shingrix, the patient experienced blood glucose increased, tremor and sweating increased palms. On an unknown date, the outcome of the blood glucose increased, tremor and sweating increased palms were recovering/resolving.   It was unknown if the reporter considered the blood glucose increased, tremor and sweating increased palms to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and at 10:16am and at 3:05pm had a blood glucose reading of over 300 despite not eating after the vaccine. The patient also reported shaking and sweaty palms. The patient was feeling better and the pharmacist plans to call at the time of reporting for follow up. The patient was a diabetic so they monitor their blood sugar.
LIGHT HEADED, FLUSH,DIZZY,FEVER'TIRED,ABD.PAIN