chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Aside from a sore arm, I developed a migraine almost 24 hours after receiving the dose. As a breastfeeding mom, I was only able to take one dose of 500mg acetaminophen, which did not help at all. I was completely incapacitated by 5:00pm; I stayed in bed with pillow over my head to block out as much noise and light as possible, and also tried to move as little as possible as every slight movement made the pain excruciating. I still had the migraine when I woke up for work the next day, but it was less painful than initially. It went away by about 2:00pm. I originally intended to report this on v-safe, but with the migraine I was unable to access the site the day it happened, and it does not let you report symptoms for previous days
Within 5 mins of vaccinations pt started feeling dizzy, pale and diaphoretic. She recovered within 10 minutes (after laying down on the exam table)
one week after receiving first dose of vaccine a raised red rash appeared at vaccination site.. it was itching and urgent care doctor prescribed hydrocortisone cream to be used 3 times a day  - itching and redness is getting better after third day of outbreak
Left arm pain side where injection was administered. Pain on lifting at shoulder, towards the front of arm & near shoulder joint, cannot sleep on left side. Pain is still present after 9 days of injection.
Within hours of having the vaccine--achey, feels that she is foggy, head hurts, eyes feels they are buldging out of her head, lymph nodes are enlarged, fatigued--a week later and still with the same symptoms  negative covid test on 12/1
DEATH FROM JANSSEN VACCINE; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was happy and enjoying life. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 25-OCT-2021, the patient experienced death from janssen vaccine. On 25-OCT-2021, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20211103989.; Sender's Comments: V0: 20211102972-JANSSEN COVID-19 VACCINE Ad26.COV2.S- DEATH. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Patient developed a mild fever and moderate chills that lasted 3 hours after the injections. Side effects resolved.
This spontaneous report as received from a nurse refers to a 25 years old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, lot # K005881, exp. date: 14-JAN-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Coughing, severe fatigue, aches, fast heartbeat, high fever (102F) all through the night. Tylenol & water. Next morning woke up without any symptoms.
Pt has a hx of seizure disorder.  Vaccine given at 0942. Seizure started at approximately 0944 and lasted until 0948. Patient was unable to converse- was attempting. It lasted approximately 4-5 minutes. Her partner was with us and assured us she was okay and did not need medical tx. She states vaccines can "sometimes shock system" but it had been a long time since she had a seizure. Second seizure occurred at 10:10 and occurred for approximately 3 minutes. Patient states she took her medication: Lamictal 150mg BID for her seizures.  Partner states that seizures can be normal for her and declined need for ambulance.
This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (my friend has been having diarrhea) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHEA (my friend has been having diarrhea). At the time of the report, DIARRHEA (my friend has been having diarrhea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported. This case was linked to MOD-2021-419573 (Patient Link).
11/22/21 presents to ED as transfer from OSH for "GI bleed". PMHx of "prostate cancer S/P resection and Alzheimer's dementia"
Headache, Myalgia, NauseaVomiting, Fatigue, Chills Narrative: Headache, chills, arm pain, fatigue day after injection. Resolved next day.
very fast heart rate, shaking, trembling, chills, nausea, headache, eyes ached, very pale, extremely tired, diarrhea
This spontaneous report was received from a certified medical assistant concerning a patient of unknown age and gender. On 05-NOV-2013, the patient was vaccinated with an expired dose of ZOSTAVAX (lot number and expiry date were reported as H012579 and 28-SEP-2013 respectively, dose and route unspecified). No concomitant therapy was reported. No adverse effects were reported. Additional information has been requested.
2nd dose received. AFter a few minutes, patietn reporting "fuzzy lip" sensation. No swelling, angioedema, chest pain, shortness of breath, tongue swelling, airway obstruction or difficulty speaking or diaphoresis. No issues with 1st dose. Monitored for 30 minutes. Symptoms improved/resolved and patient was discharged from clinic.
Administered expired vaccine after the manufacture date of expiration; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine after the manufacture date of expiration) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was unknown when the vial was stored in the refrigerator. Vial did not undergo any temperature excursions.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow-up received contains non-significant information.
Child vaccinated on 7/25/2003 with DTaP, IV Polio and MMR and developed swelling, redness and warmth at right thigh at injection site. Benadryl elixir 1 tsp every 4 hours for 3 days ordered 7/28/03 2:15 PM as well as Automepten? Elixir 1 1/2 tsp every 4 hours for T 101.5 F. Return to clinic in 1 week.
Extended period of chills, body aches, injection site pain, and fatigue lasting 48 hours.
Patient felt very tired after the vaccine. Patient instructed to lie down for 30 mins. Patient felt better and sent home with mom.
not feeling well; This is a spontaneous report from a Pfizer Sponsored Program COVAX US Support via contactable consumer. A male patient of an unspecified age received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. The patient had missed his 2nd dose because he was not feeling well on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case is cross linked to case 2018SA286322 and 2018SA286331, 2018SA288492 and 2018SA288497 (same reporter). This case involves a 70 year old male patient who experienced right deltoid was swollen about 10-15 cm at the site with redness, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history and concomitant medications were not provided. On 10-Oct-2018, the patient received a single dose of suspect FLUZONE HIGH DOSE (lot UJ037AB), expiry date 12 June 2019 in the right deltoid. On an unknown date, the patient developed a non-serious Right deltoid was swollen about 10-15 cm at the site with redness, following the administration of FLUZONE HIGH DOSE. Relevant tests were not reported. Final diagnosis was swelling at the site about 10-15 cm in size with redness. It was unknown if corrective treatment was received by the patient or not. The outcome of the event was not reported. List of documents held by sender- none.
Fever 100.5, body aches, headache, tired, chills all experienced for 24 hrs the next day after receiving the 2nd covid vaccine. Left arm was sore for 3 days.   1st covid shot I only experienced a sore arm for about 3 days.
This is a spontaneous report from a contactable Nurse via Pfizer sales representative, reporting for the daughter. A female patient of an unspecified age received the 3rd dose of TRUMENBA via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced very sore arm and significant redness at injection site on an unspecified date. She described it as looking like a "bull eye". The outcome of the events was unknown. Information on the batch number has been requested.
At approximately 10:00 p.m. on 4/21/21 I noticed that my vision was blurred.  I removed my glasses, put them back on - and still had blurred vision both near & far.  This lasted for a total of about 1.5 hours.  I also developed hives on my torso around the same time.  The hives came and went several times for about 5-7 days and were mild, not that itchy.
Severe head pain, migraine level, severe body aches all over, fever, chills, night sweats, nausea, productive cough, fatigue
A high dose flu vaccine was given to a gentleman that was below the recommended age. Patient was 57 years old and the high dose is recommended for 65 years of age and older.
Initial and follow-up information has been received from a registered nurse concerning a 50 year old female with no known drug allergies, a history of a knee operation (*post op bilateral knee*) in October 2004 and hypothyroidism who on 13-Jan-2005 was vaccinated in the left deltoid with a first dose of hepatitis A virus vaccine inactivated (Lot# 648035/0085P). Concomitant therapy included ibuprofen (ADVIL) and acetaminophen (TYLENOL) as needed. On 14-Jan-2005 the patient developed "welts from level of bra to waist." It was reported that the patient had no shortness of breath and that she will see the doctor on 18-January-2005. The patient was treated with diphenhydramine hydrochloride (BENADRYL). The nurse reported with follow-up information indicating that the patient recovered on 17-Jan-2005.  There was no produce quality complaint involved.  Additional information is not expected.
I woke to pain in hands. I have cysts on right hand to third and fourth fingers on palm to left hand and on on right hand4th finger palm. Left arm pain.-
Diverticulitis starting 2/14/21 (this condition had never been diagnosed previously). After second vaccine on 3/2/21 began experiencing hot flashes.  Have not experienced them for many years as I am post menopausal.  As time has passed I seem to be experiencing even more hot flashes.  As of today, I am still experiencing hot flashes.
Runny nose, sneezing, congestion  Started on Day 2 post vaccine at night and continued until Day 5.
6-14-2021 left arm pain and numbness 6-18-2021 massive stroke (right hemi) 6-22-2021 heart attack 6-26-2021 unspecified seizure  6-27-2021 severe chest pain 6-28-2021 shingles outbreak 6-29-2021 salmonella & staph infections detected 7-1-2021 unspecified blood in stool Extreme confusion throughout this time
had a refrigerator on which outside thermometer continued to read 5C even though there were multiple excursions, up to 23C for anywhere between 4 days and 1 month/ no adverse event; Initial information received on 13-Jun-2019 regarding an unsolicited valid non-serious case received from Other health care professional (Medical assistant).  This case is linked to cases 2019SA166192, 2019SA166193, 2019SA166194, 2019SA166195 and 2019SA164978, same reporter.  This case involves a 48 years old patient (gender unknown) who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines were given.   On 05-Jun-2019, the patient received a 0.5ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6141AB, expiry date 15-Dec-2020 via intramuscular route in the left deltoid.  It was an actual medication error due to incorrect product storage.  It was reported that had a refrigerator on which outside thermometer continued to read 5C even though there were multiple excursions, up to 23C for anywhere between 4 days and 1 month.  The patient did not experience any adverse reaction after the injection.   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.
Fever for 12 days, headache, rash, painful joints, swollen glands, chills,
Large local inflammatory reaction of left upper arm. Erythema, swelling, warmth of arm measuring 25 cm x 15 cm. Treatment - local steroids, ice, monitoring.
Vaccinations given today, please see immunization module for route, dose and assessment. Verified patient with two patient identifiers: Full Name and DOB. Consent form completed, reviewed and allergies verified with parent/guardian. Parent/guardian provided with VIS forms whom verbalized understanding and agreed with plan of care. Patient tolerated procedure well, approximately 5 minutes after administration, MOP reported redness and swelling at the site of varicella injection. Dr. assessed patient; 12.5mg BENADRYL ordered and administered PO. Vital signs take at time of administration. Parent was advised to remain in clinic for 10 additional minutes for monitoring. Vital signs taken and documented at the time of discharge. Patient discharged to home with parents with no limitations. No further adverse reactions noted.
Two days following injection I woke up violently with my heart beating wildly with difficulty breathing and I felt I had a stack of phone books resting on my chest. The significant effects of this event lasted approximately three hours. Unfortunately, for many days afterwards I had off and on shortness of breath with difficulty breathing occasional tightening of chest and jaw pain. This eventually lead to two urgent care visits starting Oct. 16 2023 (blood test, chest x-ray & EKG). The 2nd urgent care visit (Oct 19 2023) lead to an emergency room visit, looking for cardiac markers. Additional cardiac monitoring, blood work preformed. Released from ER after 6 hours. Treadmill test scheduled
Extreme nausea; chills; headache; exhaustion; This is a spontaneous report from a contactable Consumer. This 65-year-old non-pregnant female Consumer (patient) reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 19Feb2021 at 09:45 on left arm (at 65-year-old), as dose 1, single for COVID-19 immunization. The patient's medical history included coeliac disease from an unknown date and unknown if ongoing, lung issues from an unknown date and unknown if ongoing and hysterectomy from an unknown date and unknown if ongoing. The patient had no allergies. The patient's concomitant medications included levothyroxine taken for an unspecified indication, start and stop date were not reported; escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported; omeprazole (PROTONIX) taken for an unspecified indication, start and stop date were not reported; fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop date were not reported; colecalciferol (D3) taken for an unspecified indication, start and stop date were not reported and cyanocobalamin (B12-VITAMIIN) taken for an unspecified indication, start and stop date were not reported. The patient did not take other vaccine was in four weeks. The patient did not have Covid prior vaccination and was not tested for covid post vaccination. On 19Feb2021, the patient experienced extreme nausea, chills, headache and exhaustion. No treatment was received for the events. On an unknown date in 2021 the patient recovered.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
2 weeks after receiving vaccines presented to office with diffuse macular rash on face, scalp, chest and back. No other symptoms.
6.5 x 6.0 cm area of erythema with small area of induration
severe headache/migraine; severe headache/migraine; nausea; diarrhea; sore/achy muscles; weakness; chills; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 vaccine), dose 1 via an unspecified route of administration, administered in Arm Left on 21Jul2021 08:00 (Batch/Lot Number: EW0191) as dose 1, single for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing. Concomitant medications included bupropion hydrochloride (WELLBUTRIN); lamotrigine (LAMICTAL); gabapentin all taken for an unspecified indication, start and stop date were not reported. On 21Jul2021 12:00, the patient experienced severe headache/migraine, nausea, diarrhea, sore/achy muscles, weakness and chills. The patient did not received treatment for the events. The outcome of the events recovered on unspecified date in Jul2021.  Information on the lot/batch number has been requested.
Mild headache and fever the day following immunization.  Left arm soreness at injection site and lymph node swollen as of Tuesday.
sat 12/19/20 , approx 2000 , started to feel hot, burning, and itchy.  went to emergency room 12/20/20 at 1200pm , was taking Benadryl  since onset of symptoms,  given peptid, loratadine,  and have continued these medication as directed , called PMD , given hydroxyzine 12/21/20 due to severe itching and burning feeling, and currently taking at directed,
Patient complained of fever, chills, pain on immunized arm, and unable to hold food down the day after immunization.
Patient after the injection in the waiting area started to complain of dizziness, lightheadedness, feeling faint shortly after the injection. Asked for iced water (was given to the patient), also asked if it would be ok to call 911. She said yes because she did not know why she was feeling that way, called 911, first responders answered the call, and checked out the patient in the pharmacy waiting area. Told her that her BP was on the low side and her BS was normal. Patient started feeling better shortly before they arrived and decline to go with them for medical treatment. Left the pharmacy waiting area after first responders left, shortly around 7:30 p.m. with boyfriend walked out of the store.
Odd joint aches; stomach pain; felt like they were having a heart attack in the middle of night; felt like an elephant was sitting on her chest; This spontaneous case was reported by an other and describes the occurrence of CHEST PAIN (felt like they were having a heart attack in the middle of night), ABDOMINAL PAIN UPPER (stomach pain), ARTHRALGIA (Odd joint aches) and CHEST DISCOMFORT (felt like an elephant was sitting on her chest) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced CHEST PAIN (felt like they were having a heart attack in the middle of night) and CHEST DISCOMFORT (felt like an elephant was sitting on her chest). On 28-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain). On 01-Mar-2021, the patient experienced ARTHRALGIA (Odd joint aches). At the time of the report, CHEST PAIN (felt like they were having a heart attack in the middle of night) and ABDOMINAL PAIN UPPER (stomach pain) had not resolved, ARTHRALGIA (Odd joint aches) was resolving and CHEST DISCOMFORT (felt like an elephant was sitting on her chest) outcome was unknown.            Concomitant medication use was unknown Treatment information was unknown
Pt recvd 2nd dose of Hep B on 26AUG91 & the following morning pt awoke w/fever, myalgia, lt deltoid soreness, joint pain & h/a; No further details were provided;
Crying /w fever of 101 F. No prior problems. Was seen on 17May90
This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (Merck) (lot number not provided) doses which were exposed to -6.8C for 1.5 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccines have been moved to a proper storage unit. Follow-up information received from the healthcare worker. Patient information was updated. On 12-SEP-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot#, expiration date and route not reported). This is one of the several reports from the same source. Additional information has been requested.
Patient felt "weird " and became very flushed. Resolved in less than 10 minutes but observed patient for 30 minutes