chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a female current age unknown, who was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Subsequently, the patient experienced an unspecified reaction as a child. It was unknown whether medical attention was sought. Recovery status was unknown. She was getting her vaccinations updated before starting college. There was no product quality complaint. No additional information is available.
parents states p/child had 2nd & 3rd dose of vax pt devel thrush;
2 days p/vax pt devel cellulitis @ the site of vax;pt was treated w/duricef & pred & recovered;
death; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a male patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death to be related to Flu vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter's friend's father died after flu shot. The reporter stated that either the vaccines are safe or they are not.; Reported Cause(s) of Death: Death NOS
signs and symptoms:  tired, fatigued, with abdominal discomfort along with nonproductive cough with difficulty breathing. New afib Has previously had COVID.   Treatment:  RA O2, IV Bumex, Eliquis,
Intense shivering that lasted for about 1/2 hr, though I was not cold and did not have a fever.  Afterwards, muscles ached  all over body.   Took 200mg of ibuprofen and felt better but not entirely back to normal.  Malaise continued next day.
Patient developed erythema and swelling at site approximately 8mm across and 5 mm vertical.  Reported mild itching within 24 hours of injection.
localized silver dollar size-Tdap localized silver dollar size-Hep B light red macular rash Flu no induration
About 9 minutes after receiving HAVRIX, patient had L.O.C. about 5 mins. with BP 60/30 and HR about 60/min. Given 2L O2 via NC. No wheezing, edema, or erythema, or itching, after about 30 mins. of observation. BP 70/50, resp. clear; HR about 80/min. Sent home.
29hr p/vax pt called w/hives on face, neck & arms;tx w/DPh;pt to go to ER for SOB;use cool compress to hives, T101;
After vaccination L arm - L arm painful and stiff. Denies redness or edema on 11/5/09 state arm became painful heavy pain radiating to elbow and L thumb.
got itchy and hives all over, went to ER got benadryl, medrol, and vistaril. told not to get second dose of vaccine and will be on steroid pills and vistaril pills going forward as treatment.
Broke out in hives all over stomach; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the right arm on 14Apr2021 at 12:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Patient had no known allergies to food, medication or other products. Concomitant medications included ibuprofen sodium (IBUPROFEN) from an unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 15Apr2021 at 09:15, the patient experienced broke out in hives all over stomach. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event broke out in hives all over stomach was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
FEVER 102, FATIGUE, NAUSEA Narrative:  Fever 102, fatigue, nausea later the day of receiving the vaccine
Headache, Myalgia, Fever, chills, dizziness Narrative:
On Monday night I started feeling fatigued and the next day it was worse. This continued for about a week. I had intense sore throat and coughing. I went to urgent care on day 3 because I had coughed up a little blood. I tested positive for COVID-19 on June 30, 2022.
Headache on left side of head and eye, pt reported she couldn't see out of left eye. Pt reported her heart was racing and she felt nauseous. She said this happened when she had dose 1 of her covid vaccine. She said this was similar to her migraines and she took her two tablets of her medication: (acetaminophen, caffeine, butalbital). Her pain subsided and she could see out of her eye again after 30 minutes. She reported taking that medication helped resolve her symptoms after dose 1 of the covid vaccine.
After 5-6 hours felt tired, felt not dizzy but lacked equilibrium, so hard to walk, mild headache.  Symptoms mild on Saturday and Sunday.  Symptoms hardly noticeable today.
DEATH; This spontaneous report received from a consumer via social media concerned a female of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) 1 in total, dose and start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient died from an unknown cause of death. It was unknown if an autopsy was performed. The consumer reported as, "News You Murdered my sister with you Johnson and Johnson kill shot. Do you think it ends here. Sleep With One Eye Open... Track and Trace". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20230721115-Death. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sore arm; fever; tiredness; swelling arm; tingling face; injection site tingling; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on an unknown date 3 months ago, refer case US2019109637) and Shingles vacccine. Concurrent medical conditions included neurological disorder nos, back disorder and allergy nos (49 different things).   On 12th June 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In June 2019, less than a week after receiving Shingrix, the patient experienced pain in arm, fever, tiredness, swelling arm, tingling and injection site tingling. The patient was treated with acetylsalicylic acid (Aspirin) and paracetamol (Acetaminophen). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, fever, tiredness, swelling arm, tingling and injection site tingling were unknown.   It was unknown if the reporter considered the pain in arm, fever, tiredness, swelling arm, tingling and injection site tingling to be related to Shingrix.  Additional details were provided as follows: The patient had been receiving allergy and serum shots as he was allergic to 49 different things. He also had the original Shingles shot in the past.  The patient received the 2nd dose of Shingrix vaccine in the left arm.  The patient experienced sore arm, fever, tiredness, swelling of the arm, tingling of face and injection site. He had taken aspirin. He called and spoke to his nurse and he was advised to take acetaminophen. The fever goes and comes back.  The reporter had consented to follow up. No further details were provided.
Pt recvd 3 doses of Hep B vax in 1988; Following vax devel flu-like sx & was unable to work for 3 wks; lab eval on 9NOV90 titer for anti-HBs @ 20.3 units; repeat lab eval on 10DEC92 reveal a neg titer for anti-HBs;
fever of 101 ax @ 3PM;APAP given;tremors of all extremities lasting a few seconds from 10PM until 3AM;mom stated pt was starring into space for the same time period;tremors were occurring 3x a minute;
Influenza, injectable, quadrivalent, preservative-free. I had a flu vaccine on Oct. 12th. I continued a rigorous workout routine through that weekend with no problems and a couple days into the next week without any issues. Then I started feeling some cold/flu symptoms and took a couple of days off from working out and that is when both my shoulders felt tight with limited mobility (as if I had just completed a lifting routine at the gym). A day after the tightness the pain started in my shoulders and continued radiating down to my hands over a period of about two weeks. My left shoulder and arm continue to experience moderate to severe pain starting in my shoulder and radiating down to my left hand. It feels as if my shoulder is popping in and out of alignment and impinging on the nerves. My right shoulder continues to have very mild pain (mostly in the morning) with occasional sharp pain spikes during normal movement throughout the day.
Extreme pain - crying - not able to lift arm, in the morning he had a quarter size rash by 8:00 PM the rash had grown to cover half of his arm - hot splotchy (hives?). Painful.
Muscle soreness down left arm from injection site to elbow over first 36 hours. Then the soreness decreased into the next 12 hours. 49 hours post-injection, soreness was gone.
Breakthrough case admission after 3 vaccines Pfizer 4/23/21 lot# ER8732;  Pfizer 5/27/21 lot# Ew0172;  Pfizer 1/10/22 lot# FJ6369
15 year old female vaccinated with influenza vaccine (Fluarix). Patient 5 to 10 minutes after vaccination fell and hit her head. She was pale, conscious, and disoriented for approximately 2 to 3 minutes. Patient mom and patient reported not fainting in the past with vaccinations. Patient and patient mom reported patient ate approximately 2 hours before vaccination. Vital signs taken while patient was lying down BP was 100/62 and pulse 66bpm. 2 minutes later vital signs were taken with patient sitting and were BP 107/81 and pulse 108 bpm. 2 minutes later vital signs were taken with patient standing up, BP was 111/74 and pulse 84 bpm. Patient denied pain, nausea/vomitting , dizziness, and was alert and oriented to name, place, situation, and time. Patient was given juice and snack and she drank and ate them. Patient's mom denied EMS services and was instructed to monitor patient for signs of concussion and seek medical attention . Patient mom verbalized understanding and patient was observed leaving the clinic with a steady gait accompanied by mother.
Two hours after shot, sore arm, migraine like headache (dull persistent ache that grew stronger); low level stomach ache which after 20 hours became nausea.
a 36 hour excruciating migraine headache/Extended Migraine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An elderly female patient received BNT162b2 (BNT162B2), 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. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "a 36 hour excruciating migraine headache"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "a 36 hour excruciating migraine headache". The following information was reported: MIGRAINE (non-serious), outcome "unknown", described as "a 36 hour excruciating migraine headache/Extended Migraine".  Additional information : Each time, after receiving both primary series doses of the COVID-19 Vaccine, as well as their first booster shot (monovalent) the patient reported having "a 36 hour excruciating migraine headache" (No dates of receipt nor which manufacturer were specified). The reporter consider event as caused by suspect product(s) was not known for extended migraine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300095351 same patient and event, different dose;US-PFIZER INC-202300205271 same patient and event, different dose;
Pemphigus; blisters over upper body; This is a spontaneous report from a contactable physician. An 82-year-old male patient received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231), via an unspecified route of administration on left arm on 20Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included glaucoma, AMD and arrhythmia. Concomitant medication included nebivolol hydrochloride (BYSTOLIC), rosuvastatin calcium (CRESTOR) and timolol. The patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: lot number: EL 1284 on left arm) on 30Dec2020 for covid-19 immunisation and experienced hives in the back. The patient experienced pemphigus and blisters over upper body on 18Feb2021 12:00. The patient underwent lab tests and procedures which included Skin Bx: confirm pemphigus on an unspecified date. Therapeutic measures were taken as a result of pemphigus and blisters included prednisone. Outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported events "Pemphigus and blisters over upper body" cannot be completely excluded based on temporal association.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Information has been received from a medical assistant referring to an unspecified number of patients (age and gender unknown). The patients' concurrent conditions, medical history and concomitant therapies were not reported. The patients received unspecified doses in VARIVAX (lot # M000756, expiration date 06-JAN-2018, dose and route unknown) immunization series that were improperly were improperly stored. The vaccines were exposed at minus 10 degrees Celsius for 24 hours. The excursion occurred on 08-JUN-2016 and the vaccinations occurred from that point through 07-OCT-2016. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA279741, 2018SA279742, 2018SA279748, 2018SA279744, 2018SA279745, 2018SA279746, 2018SA279747, 2018SA279743 and 2018SA277209 (same reporter). This case involves a 59 years old male patient who was vaccinated with 0.5 ml dose of FLUBLOK QIV (lot QFAA1829 and expiry date: 30-Jun-2019) via intramuscular route in the left deltoid. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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. Documents held by sender: none.
unable to eat; nausea; weak; flu like reaction; Very mild symptoms; myalgia; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like reaction), ADVERSE REACTION (Very mild symptoms), MYALGIA (myalgia), NAUSEA (nausea) and ASTHENIA (weak) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008b21-2a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart disorder. Concurrent medical conditions included Diabetes and Kidney disorder (Has kidney issues.). Concomitant products included METOPROLOL, ATORVASTATIN CALCIUM (LIPITOR), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and INSULIN for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like reaction), ADVERSE REACTION (Very mild symptoms) and MYALGIA (myalgia). On 27-Mar-2021, the patient experienced NAUSEA (nausea) and ASTHENIA (weak). On 20-Apr-2021, the patient experienced FEEDING DISORDER (unable to eat). At the time of the report, INFLUENZA LIKE ILLNESS (flu like reaction), ADVERSE REACTION (Very mild symptoms), MYALGIA (myalgia), NAUSEA (nausea), ASTHENIA (weak) and FEEDING DISORDER (unable to eat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-081880 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081880:Case for second dose
Chills; tired; a dream of going over a glacier trying to slide over the other side; This is a spontaneous report from a contactable consumer(patient). A 62-years-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number: EN6198) via an unspecified route of administration, in Arm Left on 06Mar2021 08:30 as 1 DOSE, SINGLE DOSE for covid-19 immunization. The medical history was reported as none. The concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Mar2021 16:00 the patient experienced chills, tired (fatigue), a dream of going over a glacier trying to slide over the other side (abnormal dreams). The patient did not receive any treatment. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Hives onset 2 hours post vaccination.  Tx with Benadryl and Prednisone.
Information has been received from a health professional concerning a 6 year old patient who was vaccinated with a dose of varicella virus live. Subsequently the patient developed mild breakthrough varicella. It was unknown if medical attention was sought. The patient's outcome was unknown. There was no product quality complaint involved. Additional information has been requested.
Very sore; Very red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Very sore) and VACCINATION SITE ERYTHEMA (Very red) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE PAIN (Very sore) and VACCINATION SITE ERYTHEMA (Very red). At the time of the report, VACCINATION SITE PAIN (Very sore) and VACCINATION SITE ERYTHEMA (Very red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Non significant follow received on 14-jun-2021 contains No new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
C/O joint pain that stated approx. 5 days after injection. Office visit with FNP on 3-16-18 that included lab, SED rate and CBC. Started on VIMOVO 500-20 mg BID and tramadol 50 mg four times daily, PRN. Pt. returned to office on 3-28-18 with continuing C/O joint pain, myalgia additional lab was ordered, CCP, RA Factor, Vit D 25 hydroxy and was prescribed Prednisone 20 mg daily x 5 days. History of Present Illness (03/28/2018 04:28 PM) The patient is a 21 year old female who presents with joint pain. Symptoms include joint pain, migratory joint pain and decreased range of motion. Symptoms are located in the neck, upper back, lower back, left shoulder, left elbow, left wrist, left metacarpal phalangeal joint, left proximal interphalangeal joint, left distal interphalangeal joint, left hip, left knee, left ankle, left foot, right shoulder, right elbow, right wrist, right metacarpal phalangeal joint, right proximal interphalangeal joint, right distal interphalangeal joint, right hip, right knee, right ankle and right foot. The patient describes the pain as aching. Onset was sudden 3 week(s) ago. Onset followed recent immunization. The symptoms occur constantly. The patient describes this as moderate in severity and worsening. Associated symptoms include myalgia, while associated symptoms do not include muscle weakness. Current treatment includes nonsteroidal anti-inflammatory drugs. History of Present Illness (03/16/2018 10:08 AM) Patient words: all of my joints hurt, but elbows are esp. bad. Had to get meningitis shot recently, so not sure if that caused. Started on Sat. with my back. The patient is a 21 year old female patient who presents with a complaint of Joint pain. The onset of the joint pain has been sudden and has been occurring in a persistent pattern for 1 week. The course has been increasing.
Had scabs and rash 11/28/99.  As of 1/25/00 - resolved.
Passed out from standing/leaning on her bed, awoke, nausea, vomited, fatigue for two days.
Pt had initial dose of vaccine 2/13/21 and noticed being short of breath/feeling bad the following day.  He did not attend rehab on Monday, 2/15/21, as scheduled 2/2 SOB exhaustion.  He did attend today, 2/17/21< but 3 minutes into exercise on treadmill he was unable to continue.    He recovered quickly, refused clinic visit, and went home.
cried x 3 1/2-4hr cont,screaming, inconsolable, high pitched screaming;no local rxn @ site of tetra but local induration on the site of hep B/IPV;