chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The night of the vaccine I became very fatigued, had moderate muscle aches, and a mild headache. In the middle of the night I woke up with severe chills, severe muscle aches, and mild headache. The next morning I had a temperature of 99.3 which climbed throughout the day to a temperature peaking at 100.9 in the evening. I had moderate chills, severe muscle aches, severe body aches, mild headache, and moderate injection site soreness. I also felt generally ill. I took Tylenol and ibuprofen alternating starting the evening of the vaccine. Day 2 after the vaccine my temperature is 98.6, I have mild body aches and mild headache. No other symptoms remain.
PT PRESENTED TO EMERGENCY ROOM  WITH NOTED RASH THAT CAN BE DESCRIBED AS MACULAR, PAPULAR, URTICCARIAL LOCATED ON THE BODY DIFFUSELY.  THERE IS ALSO SWELLING, THAT IS MILD, OF THE RIGHT EYE AND LEFT EYE, MINIMAL SWELLING TO BOTH LIPS.  PT STATES THE SYMPTOMS BEGAN 2 DAYS AGO AND HE RECENTLY RECEIVED HIS FIRST COVID-19 VACCINE 6 DAYS AGO.  PATIENT DISCHARGED WITH THE FOLLOWING PRESCRIPTIONS:  PEPCID 20 MG, 1 TABLET ORAL EVERY 12 HOURS FOR 5 DAYS.  PREDNISONE 20 MG ORAL TABLET, 2 TABLETS ONCE DAILY FOR 5 DAYS.  VISTARIL 50 MG ORAL CAPSULE, TAKE 2 CAPSULES 4 TIMES PER DAY AS NEEDED FOR ITCHING.  PT ADVISED TO FOLLOW-UP WITH HIS PCP IN 3-4 DAYS FOR RECHECK OF TODAY'S COMPLAINTS, DO NOT DRIVE WHILE TAKING MEDICATIONS THAT MAY IMPAIR HIM, AND TO RETURN TO THE EMERGENCY ROOM IF SYMPTOMS WORSEN OR PERSIST OR IF THERE ARE ANY QUESTIONS OR CONCERNS THAT ARISE AT HOME.
Seen for joint pain in 7/21 (the joint pain started a few weeks after her second dose of the covid vaccine) -- she has now been diagnosed with lupus and glomerulonephritis -
States that about 30 minutes after she received a TDAP has been unable to move arm well. Good movement to fingers. Arm and fingers has tingling sensation - no pain to shoulder used warm and cold compresses with no relief. States took MOTRIN with no relief. No redness or swelling noted. Temp. 97.8 denies any other symptoms - states has no strength to raise arm - appears limp
Muscle aches, lightheadedness, headache, nausea, sore arm all started around 15 hours post vaccine. Still occuring 24 hours after vaccine. Chills started 24 hours after vaccine.
This literature marketed report as received from a physician, the author of a literature article. Using a multicenter, active surveillance network from 2 rotavirus seasons (2012 and 2013), the reporters assessed the vaccine effectiveness for RV5 (ROTATEQ) and RV1 (ROTARIX) rotavirus vaccines in preventing rotavirus gastroenteritis hospitalizations and emergency department (ED) visits for numerous demographic and secular strata. The reporters enrolled children hospitalized or visiting the ED with acute gastroenteritis (AGE) for the 2012 and 2013 seasons at 7 medical institutions. Stool specimen were tested for rotavirus by enzyme immunoassay and genotyped, and rotavirus vaccination histories were compared for rotavirus-positive cases and rotavirus-negative AGE controls. The reporters calculated the vaccine effectiveness (VE) for preventing rotavirus associated hospitalizations and ED visits for each vaccine, stratified by vaccine dose, season, clinical setting, age, predominant genotype, and ethnicity, RV5-specific VE analyses included 2961 subjects, 402 rotavirus cases (14%) and 2559 rotavirus-negative AGE controls. Description of 402 rotavirus cases was as below: median age, (35 months); Gender (male: 233 and female: 199); Race; Ethnicity; Insurance (private: 128 and public/none: 274); Clinical Setting (inpatient: 66 and ED: 336); Season (2012: 77 and 2013: 325). This report was concerning the 147 patients (unknown age and gender) of the 402 patients in the RV5-specific VE analyses. On unknown dates the patients were vaccinated with ROTATEQ (lot#, expiration date, dose and duration were unspecified) orally. All the patients received a full course of RV5 (per the recommended schedule of three oral doses administered at ages 2, 4, and 6 months). On unknown dates, the patients experienced acute gastroenteritis (AGE) and they were either hospitalized or seen in the ED from 01-DEC-2011 through 30-NOV-2012 (hereafter "2012") and 01-DEC-2012 through 30-NOV-2013 (hereafter "2013") with diarrhea (>=3 episodes within 24 hours) and/or vomiting (>= 1 episode within 24 hours). All of them had a rotavirus test-positive stool specimen. The outcome of events was unknown. The reporter considered the events to be related to ROTATEQ. Additional information has been requested.
Still in bed; had strong reactions; Sore arm; Chills; Foggy brain; Diarrhea; Headache; No appetite; Felt clammy; Weakness; Raspy throat; A spontaneous report was received from a consumer concerning his wife, who is a 60-years-old female patient received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events had strong reactions, sore arm, chills, foggy brain, diarrhea, headache, no appetite, felt clammy, weakness, raspy throat, still in bed.  The patient's medical history was lupus, Sjogren's syndrome, allergic to sulfa drugs and passion fruit. Concomitant medications reported were prednisone, lubiprostone, aripiprazole, acetylsalicylic acid, carisoprodol, diltiazem hydrochloride, escitalopram oxalate, folic acid, hydroxychloroquine sulfate, lamotrigine, levothyroxine sodium, lorazepam, metoprolol succinate, sumatriptan succinate, tramadol hydrochloride, prazosin, gabapentin for drug use for unknown indication.  On 2 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 027L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the patient experienced the events strong reactions. About 1 day later she had a sore arm, chills, a foggy brain, diarrhea, headache, no appetite, felt clammy, had weakness, had a raspy throat and is still in bed.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   Based on comment Pain in extremity coded as Vaccination site pain and Adverse reaction coded as Vaccination adverse reaction/PT Vaccination complication The outcome of events had strong reactions, sore arm, chills, foggy brain, diarrhea, headache, no appetite, felt clammy, weakness, raspy throat, still in bed was unknown.
28 hours after receiving DTaP had episode of sudden collapse and very short term loss of consciousness. No stiffening but acted post ictal. Temp 38 degrees at the time but was as high as 39.5 degrees. Normal exam in ER. Next day exam by me showed mouth ulcers - looked like enterovirus - still fever.
Initial information received on 10-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 30 months old patient who received 0.5 ml dose instead of 0.25 ml dose of FLUZONE (Suspension for injection) as the first out of the two initial vaccinations. Reported that an adult dose of flu vaccine was given to a pediatric patient. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication was received. On 05-Nov-2018, the patient received first single 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ005AC  (expiry date: 30-Jun-2019) via unknown route in unknown administration site. It was a case of actual medication error due to overdose NOS. It was unknown whether any adverse event occurred. 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.
Contracted nurse providing vaccinations at clinic day.  Discovered after clinic upon processing paperwork that patient was under the 16 years old protocol for Pfizer covid19 vaccine.
pt's arm is a little swollen and hot to the touch. she said the redness is growing about 3 inches
1 hr after injection she began to have bil. arm muscle pain, sympt. continued throughout the night to all joints hurt, full body musc. pains, skin sensitivity, moderate to severe HA, nausea, temp next AM was 101.1 in clinic, (L) deltoid with moderate swelling and tenderness and warmth; sympt. tx only from the clinic.
c/o numbness, tingling, tightness right side of face, could hardly open mouth.  given two 12.5 mg. child Benadryl strips.  taken to Goshen General Hospital ER. 4/1/09-records recieved for DOS 3/21/09-presented to ED with C/O swelling to jaw and jaw felt tight like it was locking. DX: Possible adverse reaction to immunization not found.
I already did . I don't feel well and I am not going to write more. I'm sick.
Tinnitus, anxiety, eustachian tube dysfunction, ear fullness, jaw and neck pain, and acid reflux all on-going since booster.
This case was reported by a nurse and described a patient who did not respond to immunization with hepatitis B vaccine recombinant (Engerix B).  On an unspecified date, the patient received the sixth dose of hepatitis B vaccine (manufacture unknown). Subsequently, on an unspecified date on or before 05/02/2005, a hepatitis B surface antibody titer was negative.
vesicular rash, which was diagnosed as severe herpes zoster or shingles; The vaccine did not prevent shingles as intended; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age or gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided.   In 2009, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, strength, administration route, anatomical location, lot number and expiration date were not reported) for routine adult health maintenance and for the long-term prevention of shingles.The reporter stated that the vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later on or about 23-MAY-2016, the patient was treated by a physician assistant, for a severe vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles. The patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages.
Initial and follow up information  has been received from a physician, concerning a 15 year old female patient with a history of "fainted once with a blood draw," who on an unspecified date, was vaccinated IM with the second dose, 0.5 ml, of GARDASIL (lot # 659655/1486U). After vaccination, the patient became pale, and felt shaky; the physician indicated that "it could have been a complicated fainting spell." The patient "had 10 seconds of jerking- some clonus." She recovered, but "Thurs. still dizzy & nauseated." The outcome of dizzy and nauseated was not specified. Additional information is not expected.
Next morning awoke extremely feeling overall ill. I could not stand on my own and hold my balance. My head was spinning all around. Can not remember other symptoms because loss of balance was the worst but my doctor has other documented.
My son started having tics the day after his vaccine. His tics include facial grimacing and his head jerking  to his right side. This happens multiple times in a 5 minute timeframe. This never happened before and it has not stopped since.
Bitter taste with food and drink for 2 hours post injection; This is a spontaneous report from a contactable other Healthcare Professional (HCP, patient).  A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot # ej1685), intramuscular, on 19Dec2020 at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was vaccinated at hospital, age at vaccination was 49-years-old. No other vaccines were administered within 4 weeks prior to the COVID vaccine. Medical history included allergies to iodine, migraine, and gastrooesophageal reflux disease (GERD). Concomitant medications included duloxetine, erenumab aooe (AIMOVIG), and ubrogepant (UBRELVY) The patient experienced bitter taste with food and drink for 2 hours post injection on 19Dec2020 at 05:30 PM, reported as non-serious. No treatment was received for the event. The patient recovered from the event on an unknown date in Dec2020.
This spontaneous report as received from a registered nurse refers to an unspecified number of unspecified patients of unknown age and gender. Patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot number L019835 and expiration date 23-MAR-2017, dose and route of administration were not reported). The temperature and the time frame of the excursion were 12.3 Celsius degrees for 83 hours and 40 minutes and -3.4 Celsius degrees for 105 hours and 50 minutes. There was no previous temperature excursion and it was stated it was a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved This is one of several reports received from the same reporter. Additional information has been requested.
she received the vaccine 20-JUL-2023 and had a minor muscle ache after but is fine now.; HCP states the product was not white prior to administration and she read in the PI taht it states you must shake the vaccine and it should turn white prior to administration; This spontaneous report was received from a 52-year-old female physician patient regarding herself. There was no information about patient's concurrent conditions or pertinent medical history.  Concomitant therapies included levothyroxine sodium(SYNTHROID).     On 20-JUL-2023, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly (dose, anatomical location, lot number and expiration date were not reported) "just to be safe" (prophylaxis).  The patient inquire if she should be revaccinated, or if the vaccine was still viable since she did not see anyone shake the vial of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) prior to administration. The patient stated that the product was not white prior to administration, and she read in the PI that it stated you must shake the vaccine and it should turn white prior to administration (product use issue). On 20-JUL-2023, the patient had a minor muscle ache (myalgia). No sought medical attention or treatment was given to the patient.   At the time of the report, the patient had recovered from the event on an unknow date in July 2023 (described as she was fine now). The patient requested the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) from a doctor and ordered it and received it from a doctor in a walk-in OB/GYN clinic that she did not know the name of the healthcare professional.  The relatedness between the event of myalgia and therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.
Erythema on L thigh with chicken pox looking lesions warm compresses + Augmentin x 5 days.
Patient started breaking out with it with redness and swelling. Received meningitis injection. No systemic symptoms. ER sheets attached.
Left arm started swelling up on 10/22. Arm was warm and continued to swell up. Went to Dr on 10/24 & they ordered a MEDROL dose pak for the inflammation. Provider said due to ADACEL & Pneumo together.
On left arm, Red swelling, about 3 inches wide by 1.5 inches high. Warm & very tender to touch.  Wakes me up at night if I roll onto that arm. Taking 800 mg ibuprofen every 8 hours to relieve some tenderness.  I?ve never had a reaction like this to any vaccine nor my previous Covid-19 shots & boosters (all by Pfizer)
Patient developed Cellulitis below the shot area.  He was traveling out of the country immediately following the shot so he was unable to report until he was back.
hallucinating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 32 years for covid-19 immunisation. The patient's relevant medical history included: "Latex allergy" (unspecified if ongoing); "Lupus" (unspecified if ongoing); "rheumatoid arthritis" (unspecified if ongoing); "epilepsy" (unspecified if ongoing). Concomitant medication(s) included: PREVNAR 20 taken for immunisation, on 16Oct2023 as unk, single; FLU VACCINE VII taken for immunisation, on 16Oct2023 as unk, single; VENLAFAXINE, start date: Jan2010, stop date: 17Oct2023; SUMATRIPTAN, start date: Jan2021, stop date: Oct2023; UBRELVY, start date: Jan2021, stop date: Oct2023; ALPRAZOLAM, start date: Jan2010, stop date: Oct2023; TIZANIDINE, start date: Jan2020, stop date: Oct2023; NORCO, start date: Jan2011, stop date: Oct2023; BUSPIRONE, start date: Jan2022, stop date: Oct2023; DEXTROAMPHETAMINE [DEXAMFETAMINE], start date: Jan2010, stop date: Oct2023; ETHINYL ESTRADIOL, start date: Jan2009, stop date: Oct2023; HYDROXYZINE, start date: Sep2023, stop date: Oct2023; TREMFYA, start date: Jan2023, stop date: Oct2023; GABAPENTIN, start date: Jan2010, stop date: Oct2023; PREDNISONE, start date: Jan2011, stop date: Oct2023; TOPIRAMATE, start date: Jan2017, stop date: Oct2023; HYDROXYCHLOROQUINE, start date: Jan2011, stop date: Oct2023; EMGALITY [GALCANEZUMAB GNLM], start date: Jan2019, stop date: Oct2023; LEVETIRACETAM, start date: Jan2018, stop date: Oct2023. The following information was reported: HALLUCINATION (medically significant) with onset 16Oct2023 at 10:00, outcome "recovered", described as "hallucinating". Therapeutic measures were not taken as a result of hallucination. Clinical course was reported as follows: Several hours after receiving the vaccine patient began hallucinating. It lasted for several hours. The day she received the covid vaccine she also received flu shot and prevnar 20. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Son called the morning of 11-9-2016 and reported that patient had redness and swelling of right arm. She also had AMS and was playing in food; when pt was brought into office she did have swelling of Rt arm (upper) and was complaining of all over body pain, slight fever, after evaluation she was sent to ER later was admitted and Dx with UTI.
Patient received his first dose of Pfizer covid vaccine 2/26/21 and second dose 3/19/2021. On labs from 6/29/21 he had leukopenia and neutropenia for the first time and this has been persistent since. He had his third dose of pfizer covid vaccine 10/18/2021. CT 1/20/22 showed splenomegaly. He had his 4th dose of COVID vaccine 5/2/2022. On 9/8/22 he presented to the ED for an unrelated injury and was found to have worsening leukpenia and neutropenia and new blast cells. This patient is scheduled for bone marrow biopsy to confirm leukemia diagnosis.
No adverse event at this moment. Patient received the wrong vaccine. Patient received ½ dose (0.25mL) of Moderna. The only vaccine patient qualified to receive is Pfizer (12 and above).
Patient received Pfizer COVID vaccine on 3/9/21 and 3/30/21. On 3/20/22, patient admitted to our inpatient facility with acute respiratory failure with hypoxia secondary to COVID-19 pneumonia. As of today (3/23/22), patient is still admitted in our med/surg unit.
1 of 3 pts immunized from the same pnu-immune lot# who devel an adverse event;pt vaxed 28FEB95 devel high fever,feeling weak,head congestion,chills,large local redness around inj site & other flu-like sx x 1wk;recovered;
Extreme fatigue; brain fog; Passed out; Told possible seizure; Felt ill shortly after receiving shot; Threw up; This is a spontaneous report from a contactable consumer (the patient) and then from a contactable consumer (the patient's wife). A 59-year-old male patient received the first dose of BNT162B2 (lot number not provided), via an unspecified route of administration in the left arm on 31Mar2021 10:00 (at the age of 59-years-old) as a single dose for COVID-19 immunization. The patient had no medical history. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included: fish oil (OMEGA 3 FISH OIL). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, the patient felt ill shortly after receiving the shot. Told to sit down. Passed out. Awoke on the floor. Told possible seizure. Sat up. Threw up. Told to lie back down. Ambulance came and took him to the hospital. He spent 90 minutes in the Emergency Room. He was unable to work for a couple of days. He had extreme fatigue and brain fog. He was not back to relatively normal for at least 10 days. Treatment received was reported as yes: ran tests including 3 EKGs, on an unspecified date. The outcome of the events was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   Information on the lot/batch number has been requested.
My head hurt. My sinuses were affected so I was congested. I had some coughing and ran a temperature of 102. I was very tired.
Area was painful; Area was swollen; Area was warm to touch; Redness at the site of injection; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site warmth and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site warmth and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Four to five months before the time of reporting, the patient received a dose of Shingrix on the right arm. There was some redness at the site of injection following administration.   The following day the area was painful, swollen and warm to the touch.  It was lasted approximately 2 weeks before resolving. The reporter consented to follow up.
Narrative:  67yr M with history of HF. Died on 06/25/2021. Patient received Covid vaccines on 03/05/2021 and 04/02/2021. Patient died at home. No other information provided. Likely death is not related to covid vaccinations.