chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in right arm on 21Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 22Apr2021, the patient was woken up by a buzzing on her right ear. The patient described it as a not too high buzz that appears every two minutes. The patient stated that she did not present tinnitus before having the vaccine and that it impacts her sleeping, she thought that her ear drum was pressed by something and that she read online that other people have also presented tinnitus. The patient would like to know if there was any correlation with vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
The Patient reports general malaise, fever, acute diarrhea and pain in the R+ deltoid arm.
Improperly stored PROQUAD was administered to patient; No adverse event; This spontaneous report was received from medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug allergies/reactions and concomitant medications were not reported. On 18-SEP-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, formulation, dose/frequency, route were unknown) lot # S003176, expiry date: 30-JUL-2020 for prophylaxis (product storage error). The vaccine was stored at a temperature of 3.4 degree Celsius(minus 9 degree Celsius to minus 8 degree Celsius) for 98 hours 45 minutes. There was no previous temperature excursion. The call was because of data logger. No adverse effect was reported. The outcome of product storage error and no adverse event was unknown.
Arm soreness; Fatigue; General malaise; Low grade temp; Headache; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiry date: not provided) solution for injection at a hospital, via an unspecified route of administration (on left arm) on 17Dec2020 14:00 at a single dose for COVID-19 immunisation. Medical history included allergy to Sulfa, and FS (flushing and sweating). Concomitant medication included estrogens esterified, methyltestosterone (ESTRATEST) daily. The patient received the vaccine on left arm, dose number 1. The patient experienced arm soreness, fatigue, general malaise, low grade temp, and headache on 17Dec2020. No treatment was given. The events were reported as non-serious. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the Covid-19 vaccine; patient has not been tested or diagnosed of Covid-19. Outcome of the events was recovering.    No follow-up attempts needed. No further information was expected.
Diarrhea and upset stomach (mentioned first).  Feverish feeling; fever not verified; patient didn't have thermometer.  Fatigue.  Time course that evening, next day.  Recommended APAP (OTC) and fluids.  (Diarrhea is not a side effect of vaccine).
maculopapular exanthema concentrated on L thigh and around L eye and scattered elsewhere.
body aches the next day; tiredness; This non-serious case was reported by a consumer via call center representative and described the occurrence of general body pain in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of fatigue (1st dose received on 23rd March 2021, refer case US2023109506).   On 18-JUN-2021, the patient received the 2nd dose of Shingrix. On 19-JUN-2021, 1 days after receiving Shingrix, the patient experienced general body pain (Verbatim: body aches the next day) and tiredness (Verbatim: tiredness).  Rechallenge with Shingrix was positive. The outcome of the general body pain and tiredness were resolved (duration 24 hrs).   It was unknown if the reporter considered the general body pain and tiredness to be related to Shingrix.     It was unknown if the company considered the general body pain and tiredness to be related to Shingrix.   Linked case(s) involving the same patient:  US2023109506   Additional Information: GSK Receipt date: 11-AUG-2023 The reporter was the wife of the patient. After the patient received the second dose, the patient experienced the same events, tiredness and body aches the next day which lasted for 24 hours. The reporter consented to follow up.   Follow up information received on 03-OCT-2023 Summary of changes: reporter details and  event details were updated.
She received her 4 yr shots on 9-5. On 9-6 am mom noted her left deltoid area was red and itchy. It progressed over the next 2 days and site and she came in today to have it evaluated 9-11-17-called and it is resolved-mom says only slight bruising.
Mild allergic reaction; Pink skin; Warm; Sweaty; Mild difficulty for breathing that lasted some minutes; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Mild allergic reaction), SKIN DISCOLOURATION (Pink skin), FEELING HOT (Warm), HYPERHIDROSIS (Sweaty) and DYSPNOEA (Mild difficulty for breathing that lasted some minutes) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced ALLERGY TO VACCINE (Mild allergic reaction), SKIN DISCOLOURATION (Pink skin), FEELING HOT (Warm), HYPERHIDROSIS (Sweaty) and DYSPNOEA (Mild difficulty for breathing that lasted some minutes). On 22-Mar-2021, DYSPNOEA (Mild difficulty for breathing that lasted some minutes) had resolved. At the time of the report, ALLERGY TO VACCINE (Mild allergic reaction), SKIN DISCOLOURATION (Pink skin), FEELING HOT (Warm) and HYPERHIDROSIS (Sweaty) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
PT. PRESENTED TO HEALTH DEPT. ON 05/20/2010 @ 11AM WITH C/O PAIN AT DISTAL END OF LEFT DELTOID. PT STATED THAT IT HAS HURT SINCE RECEIVING THE VACCINE. SITE BECAME RED AND SWOLLEN, LASTING A FEW DAYS, AND SHE WAS UNABLE TO SLEEP ON HER LEFT SIDE DUE TO PAIN. SWELLING HAS SINCE RESOLVED BUT PAIN REMAINS. PAIN IS NOT CONSTANT BUT IS PAINFUL TO TOUCH. SITE APPEARS CLEAR, NOT RED OR SWOLLEN.
Hospitalization for Transient Global Amnesia.  Confusion, loss of memory for approximately 6 hours.
Patient presented for her first vaccination. Patient stated she was very nervous and scared of needles. Patient's skin felt warm.  RN talked with patient for close to 5 min and worked through deep breathing exercises to assist in calming her. After the dose, the patient stood up, walked to the opposite corner of the room, and put her long sleeved shirt back on under her scrub top. As the patient began to walk out the door. RN met patient and went to walk with her to the sitting/monitoring room. The patient said she felt dizzy. RN helped the patient to the floor, on her knees, and then to a laying down position.  A pillow was placed under her head, cool cloth was placed on her neck.   Patient's eyes were rolled back in her head. Patient's skin was warm to the touch.  Patient was assisted from the floor to a chair.  Patient was pivot transferred to a wheelchair, and transferred to the monitoring room for further monitoring. At this time, the patient stated she felt cold and her hands were very cold to the touch.   Patient was monitored by RN. Patient was then transferred to the ED via wheelchair for further monitoring.
This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE NODULE (red knot under her injection site) and CHILLS (Chills) in a 74-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 26-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced INJECTION SITE NODULE (red knot under her injection site) and CHILLS (Chills). At the time of the report, INJECTION SITE NODULE (red knot under her injection site) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pt complain of SOB, no apparent distress noted. Speaking in full sentences. Pt stated had a rough year and was anxiuos. itals obtained and patient refused transport.
Paralysis of left arm from shoulder down to elbow.  Muscles are starting to atrophy due to lack of use.   Patient is currently seeing a physical therapist.
Gave booster to 17 yo. Staffing missed pt was not 18 yo yet. No adverse reactions notes/reported
Site: Redness at Injection Site-Medium, Additional Details: patient called pharmacy regarding adverse reaction to vaccine; started with swelling and warmth under arm, now spreading to larger area of right arm. i advised patient contacting physician for further guidance
This spontaneous report as received from a physician who reported that 90-100 patients were inadvertently administered 5 vaccines for prophylaxis from December 2013 to March 2014 that had been improperly stored. This report refers to unknown number of these patients who were vaccinated with VAQTA had been improperly stored. No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected.
3 hours after 2mo vaccines, pt had a "shaking" episode. Started in (R) leg and progressed to the entire body. Symptoms lasted for a few seconds. No other symptoms reported.
L EYE SWELLING STARTED 1-2 HOURS POST INJECTION-WENT TO URGENT CARE SAME DAY FOR EVAL.  GIVEN ORAL STEROIDS/ZYRTEC.  STATES IMPROVED AFTER STEROIDS.
red raised rash to chest, anterior neck, upper back & rt forearm (inner aspect) approx 3 days p/flu vax;pt states also started new med approx 10 days ago;afeb;
Thrusday - Morning:  Got Shingles Vaccine:  By Evening:  Sever Joint Pain (hands, wrists, hips, shoulder, neck feet, and back) began the around 8pm followed by chills.  I had to put an extra blanket on the bed.  Headache.  Swollen area (about 3 inches across) at injection site on right upper arm  became hot and very tender to touch. Slight nausea.  Inability to sleep.  And TWICE in the middle of that same night  I got up to urinate and started leaking as soon as I stood up (which is NOT normal for me).    Friday Morning:  I had some issues with mild feelings of urinary incontinence but nothing like that first night.  I continued to feel awful with the joint aches (sever enough to make walking a bit difficult), headache, chills, heat and soreness at injection site and some swelling along back of arm into right armpit. Sleeping was still difficult but possible.     Saturday Morning:  Still feeling aches (walking still affected) and chills along with hot and sore injection site.
Swollen left arm from shoulder to elbow, red, looks like she worked out. Reported 8/21/02. Talked to on call doctor; said to apply cool compresses. Swelling down today 8/23/02, but not completely gone.
temp immed post vax-seemed to devel some type of sz;cont to have sz since that day;excessive vomiting 3 to 4 X daily;sx 2 to 3 X daily;not nl self;rx phenobarb;
Right and Left Deltoid red and hot at touch. States noted redness and swelling on 10/15/08 but thought it was normal. Suggested to be seen by an MD. Size 3-4 inches. redness remains on upper arm.
Body aches; This is a spontaneous report from contactable consumer(patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date as SINGLE DOSE for covid-19 immunisation.  The patient medical history and the concomitant medications were not reported.  The patient experienced body aches on an unspecified date with outcome of unknown  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th January 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 12th January 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 12-Jan-2023 Reporter's comment: The reporter was not wiling to give details on the patient and also did not gave consent to follow-up by the safety team. The reporter did not consent to follow-up. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
his son may have gotten less than a full dose of MMRII; his son may have gotten less than a full dose of MMRII; No adverse effect reported; This spontaneous report has been received from the patient's parent, concerning a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not provided.     On an unknown date, the patient could had vaccinated with a less than full dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, frequency, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. No adverse effect reported.
So far there are no adverse effects, but I mistakenly administered the Pfizer Bivalent Booster to this 11 year old patient today, I simply overlooked her DOB of birth on the form and did not realize she was not old enough.  Father of patient was notified this evening around 10:00 p.m. after the discovery of the error was made once we returned to the pharmacy after the flu shot/covid shot event and started scanning the consent forms into the computer system. Our computer system would not allow us to select Pfizer Bivalent Booster 12+  because the patient was not 12 years old.  Told father I would call tomorrow to check on daughter.
patient was given Menactra dose on 23JUL2021 and again today, 24AUG2021 with no reported adverse event; Initial information received on 24-Aug-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an 18 years old female patient who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] on 23-Jul-2021 and again on 24-Aug-2021.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE (HPV VACCINE) for Immunisation.  On 23-Jul-2021, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.   On 24-Aug-2021 again received 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE with lot U7140AA, expiry date- 04-Nov-2022 via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to extra dose administered.  At time of reporting, no adverse event was reported.  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 the 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.  There will be no information available on the batch number for this case.
Neck tightening, throat swelling, itchy tongue rated 7/10 for severity. Gave Benadryl liquid 10ml - immediate relief.  Second dose 4 hrs later at 10ml.  Third dose 10ml - 6 hrs later for maintenance.  No further dose needed.
presents the hospital ER complaining of cough, fever and shortness of breath. Patient states that his wife did have coronavirus 19. His symptoms did start today in the morning. Patient is still currently on immunosuppressive therapy for the liver transplant.
This spontaneous report as received from a medical assistant also reported as healthcare worker refers to an unspecified group of patients of unknown demographics. Patients' medical histories were not provided. On an unspecified dates in 2014, the patients were vaccinated with doses of PEDVAXHIB (dose, frequency, route of administration and lot # were not reported) which were exposed to an unsupported temperature excursion since 02-NOV-2014. Concomitant medication was not reported. The reporting medical assistant was not aware of any adverse effects. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Joint pain lasting 30 days, rash on ALL parts of body starting one week after 2nd dose STILL active, itching, painful. Steroid pack and cream used with no results.
Nausea, diarrhea, fever, muscle pain, joint pain, chills, lethargic
Since 29 December he has complained of recurrent episodes of generalized itching and rashes described as raised, red, itchy whelts which can occur anywhere on his body, especially at sites of pressure or where his skin is scraped or scratched. Lesions last less than 24 hours, affect his palms and soles, and resolve without post-inflammatory changes. He denies laryngeal, pulmonary, GI, neurologic, and cardiovascular symptoms with these episodes. Episodes not associated with heat, exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, infections, or insect bites/stings. He received his Moderna COVID-19 vaccine booster dose on 17 December, 12 days prior to onset of symptoms. He has used oral antihistamines with benefit. He denies constitutional symptoms. UCT score today is 19 (0, 3, 1, 4, 4, 4, 1, 2). No history of adverse reactions to prior vaccines.
My husband  it was for his second dose of the vaccine, bit at the next day at the morning  got a kind of burn like a water pump which at first there were some in that area but the next day it became a big pump like water inside, today, Monday, April 26, that pump woke up. and it has been like when you have a burn you have not had a fever only muscle pain in your arm, and have taken tylenol
Bright red bumps on buttocks, back, neck and limbs. Fever, stomach ache and diarrhea.
Dizziness and spinning suddenly while lying in bed.   Woke up to feeling off severe dizziness.    Mildly nauseous as well.  Persisted as light headedness and mild dizziness through the day.   Blood pressure routinely checked and normal.   HR normal.   No fever.   No recent head trauma.  Never had this before.   No new or different foods in prior days.
pt recv vax & evening of vax pt was wound up, had a sl h/a & was irritable & exp a sleepiness noc; No further details provided;
Onset of 100 degree fever accompanied with body aches and migraine headache without aura. Treated with 1 gram acetaminophen every 6-8 hours. fever broke Saturday 9/4/21 in the afternoon. Vaccine injection site is still a red, hot, itchy lump that hurts to touch as of today 9/7/21
PATIENT'S THROAT BEGAN TO ITCH, IMMEDIATELY GAVE PATIENT BENADRYL SYRUP 10 ML BY MOUTH AT 1046AM . BY 1055 PATIENT SYMPTOMS RESOLVED. INSTRUCTED PATIENT TO CALL IMMEDIATELY IF ANY OTHER ISSUES CAME UP AND GO TO ER
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 10 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Nov2021 19:30 (Batch/Lot number: unknown) at the age of 10 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Known allergies: Intolerance to peanuts (not anaphylactic)" (unspecified if ongoing). There were no concomitant medications. The following information was reported: NAUSEA (non-serious) with onset 07Nov2021 23:30, outcome "recovered", described as "Nausea"; VOMITING (non-serious) with onset 07Nov2021 23:30, outcome "recovered", described as "vomiting". Therapeutic measures were not taken as a result of nausea, vomiting. Additional information: No other vaccine in four weeks and no other medications in two weeks. No Covid prior vaccination and No Covid tested post vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Horrible periods, started a couple months after injection. Diagnosed with endometriosis, and PCOS at 21. 5 years worth of bad PAP smears. HPV always noted.
Several months after the vaccine was administered I began to suffer from anxiety as well as tremors and tinnitus.  I am on medication for the anxiety, but have been advised there is nothing that can be done for the tinnitus.  With respect to the tremors I am still under going tests to attempt to narrow down my options.