chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ringing in my ears; it's getting increasingly harder for me to hear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "ringing in my ears"; HYPOACUSIS (non-serious), outcome "not recovered", described as "it's getting increasingly harder for me to hear".  Additional information: patient had received 2 doses and a booster of your Covid 19 vaccination. Unfortunately, immediately after his first dose he started experiencing ringing in his ears. He spoke with his physician and allergist, and they had no answers. He had been lived with this ringing for 2 years now and he wanted to know if there was anything you can do for him to help him get it to stop? He was an actor, and it was getting increasingly harder for him to hear his cues on set.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
infection soreness day of vaccine with redness noted at site and also 2 days later.  Then on January 19, 2021 noticed redness again to administration site.
I woke up about 4:30 the morning after the vaccine and  had shoulder pain at the injection site,. Flulike symptoms and fever of 101.0 began later that evening and felt bad with a headache for about three days.
Woke up at 7 am on the 19, Feeling extreme fatigue, body aches, low grade temp. I called the virtual IU Health line to report symptoms. I spent all day in bed till symptoms started to subside which was around 4:30pm 01/19/2021. I was completely symptom free by 01/20/2021 at 0930 am.
pt described swelling in the mouth & ulcerations the day following the vax; 6 days following inject pt presented w/large whelps @ the inject site;
Patient reports that about 2 weeks ago he received antibody therapy for Sars-CoV-2; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: POTENTIATING DRUG INTERACTION (non-serious) with onset 2021, outcome "unknown", described as "Patient reports that about 2 weeks ago he received antibody therapy for Sars-CoV-2". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information included: Patient had 1st dose of Covid vaccine 3 weeks ago and was due for 2nd dose on the date of reporting. It was reported that second dose of Pfizer-Biontech Covid19 vaccine might delay due to antibody therapy. Patient did not confirm whether he had an active infection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
tinnitus, hearing loss in right ear, ear fullness and pressure, subacute thyroiditis
Patient blacked out and fell on the floor.  I was alerted to what happened. When I went to investigate what happened she was disoriented and laying on the floor. Afterwards she recovered from fainting and disorientation quickly. She had chills, a sore arm, and general feelings of tiredness and feeling unwell.
Woke up the morning of 12/24/20 and had Developed raised red rash with itching to right shoulder, chest and arm down to the hand. Rash only developed on The right side, did not move down to abdomen or legs at all. Also developed blister in the mouth only on the right side on the roof of the mouth. Took Benadryl and applied cortisone cream topically to rash. At this time 12/26 0800 most of the task has resolved only remaining in on the back of the right hand and wrist and the blisters in the mouth remain.
NO adverse reaction to vaccine, reporting that received 1st dose as Pfizer and 2nd dose Moderna and no treatment required: Nurse administered dose of Moderna as her 2nd vaccine without inquiring what 1st dose was (an RN at the hospital). I have reminded nurse to verify that receives same vaccine for 2nd as 1st dose that should only "mix and match" for booster doses
This spontaneous report was received from a physician referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 which had lot# M014929 and expiry date: 27-MAY-2017 (dose and route not reported). No adverse effects and no product quality complaint (PQC) was reported. No further information provided. This is one of the three reports received from the same reporter. Additional information has been requested.
Diarrhea started on or about 10/12/07 followed by vomiting. Admitted to hospital 10/16/07. KUB showed obstruction - transferred to another hospital.  11/2/07 Reviewed hospital medical records from 1st hospital which reveal patient experienced intermittent diarrhea x 1 week w/reduced oral intake progressing to emesis & fever.  Admitted 10/16-10/17/2007 for rehydration due to probable gastroenteritis.  Had bloody stool after admit.  Transferred to higher level of care. FINAL DX: Intussusception.  Records faxed to CDC. 11/6/07 Received medical records from 2nd hospital which reveal patient experienced vomiting, fever & diarrhea for 8-10 days.  Admitted 10/17-10/18/07 for overnight observation s/p BE reduction of IS.  No d/c summary available, t/c to medical records for d/c date. FINAL DX: Intussusception, enema reduced.  Records faxed to CDC.  12/18/07 Received vax record which provided RO lot & dose # & confirmed other vax as reported.
Systemic: seizure-Medium, Systemic: Seizure-Medium, Additional Details: Patient was fine for apprxo 5 min after vaccination, fell off chair with seizure, paramedics were called and came, watched her for any sign of further problems, she did not require a trip to the hospital, they left and she remained for approx 20 more minutes, during which time she slept for a little while
about 10 pts recvd Engerix-B & exp pain @ inject site w/2nd dose only immediately w/shot;
pt loss consciousness about 10mins p/vax;redness to inj site about 5cm in diameter; p/deep verbal & touch stimulation pt arouse, about 25 to 30mins from onset of events;redness cont to be present to bilateral inj site;
tightness in chest; fast heart beat; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (tightness in chest) and HEART RATE INCREASED (fast heart beat) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced CHEST DISCOMFORT (tightness in chest) and HEART RATE INCREASED (fast heart beat). The patient was treated with IBUPROFEN for Heart rate high, at a dose of 1 dosage form. At the time of the report, CHEST DISCOMFORT (tightness in chest) and HEART RATE INCREASED (fast heart beat) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Diffuse myalgias, fatigue, joint pains, increased LFT's. Followed at office with Rheumatology consult, GI, ID consult. OTC NSAIDS, increased fluids. Improving.
received a third dose of bexsero; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB58AA, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero (1st and 2nd dose received on an unknown date).   On 29th July 2022, the patient received the 3rd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 29th July 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered 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: 29-JUL-2022 Reporter's Comments: The health care professional reported that the patient received a third dose of bexsero. Additional supportive information: The patient received third dose of Bexsero, which led extra dose administered. The reporter consented to follow up.
A non-serious spontaneous report of administration of FLUMIST to 21-month-old was received from a health professional. Neither relevant past medical history no concomitant medications were reported for this patient. On 11-Oct-2011, the patient received FLUMIST. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Body aches, Temp 100, left arm soreness treated with tylenol and ibuprofen. fever and body aches subsided after 15 hours
w/in 3mins of inj & climbing one flight of stairs pt devel dry heaves, dizziness, light headedness & flushing;pt sat down for 10mins, the came back to area where recvd vax, neg for all sxs x/upset stomach;sent to ER & monitored for 1 hr
The day after receive the vaccines I could not lift my left arm for 3 days because of the pain. I sought no medical attention. Although the pain is almost gone it's been over a month! Previously I've had many flu shots 2 pneumonia with no effects at all.
Positive covid test after the vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive covid test after the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SARS-COV-2 TEST POSITIVE (Positive covid test after the vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive covid test after the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. No concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Non-Significant follow up Email and  updated.; Sender's Comments: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of SAR-COV-2 test positive after vaccination, the event is assessed as unlikely related to mRNA-1273.
NUMBNESS ON FINGERS AND FINGER TIPS; BODY ACHE; TIGHTNESS ON FOREARM; SWOLLEN ARMPIT; SORE AND TENDER LEFT ARMPIT; FEVER; HEADACHES; CHILLS; This spontaneous report received from a patient concerned a 51 year old female. 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 not reported, batch number: 202421A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced swollen armpit. On 09-APR-2021, the subject experienced sore and tender left armpit. On 09-APR-2021, the subject experienced body ache. On 09-APR-2021, the subject experienced tightness on forearm. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced headaches. Laboratory data included: Body temperature (NR: not provided) 100.2 F. On 11-APR-2021, the subject experienced numbness on fingers and finger tips. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, and headaches on 10-APR-2021, chills on 11-APR-2021, and fever on 09-APR-2021, and had not recovered from tightness on forearm, swollen armpit, sore and tender left armpit, and numbness on fingers and finger tips. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as the case assessed as non-serious.
C/o itching, redness and hard area at site of injection. BENADRYL 25 mg po given.
This spontaneous report was received from a pharmacist concerning a 70 year old female patient. The patient's concurrent conditions included acid reflux disease. The patient had none drug reactions, allergies or concomitant medications. On 14-JUN-2017, the patient was vaccinated with a single dose of PNEUMOVAX 23 injection, intramuscularly in her left arm, lot number N003997, expiration date 28-OCT-2018 (strength and dose were not reported) for prophylaxis. On the same date (reported as "later that day"), the patient experienced severe swelling of the left arm. The patient was sent to a local unspecified hospital and she was admitted on 14-JUN-2017. The patient was currently being treated with unspecified intravenous antibiotic medication. The pharmacist requested a lot check as soon as possible because she was concerned about using PNEUMOVAX 23 stocked in the pharmacy. At the time of the report, the patient had not recovered from the event. The causality assessment between the event and the PNEUMOVAX 23 was not reported. Additional information has been requested.
Fever; restless sleep; Found what appears to be a fungal infection on my tongue (plaque can be scrapped off); chills; This is a spontaneous report from a contactable consumer (patient himself). A 26-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0171; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 26Apr2021 12:00 (at age of 26-years-old) as DOSE 2, SINGLE and patient had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0150; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 05Apr2021 14:00 (at age of 26-years-old) as DOSE 1, SINGLE both for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 27Apr2021 03:00 the patient experienced fever, chills, restless sleep and found what appears to be a fungal infection on my tongue (plaque can be scrapped off). Patient did not receive any treatment for AEs. The patient underwent lab tests and procedures which included SARS-COV-1 test (Post vaccination; Nasal Swab) which was negative on 21Apr2021. The outcome of all events was resolved on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Several hours after receiving my second dose of the SHINGRIX vaccine, I experienced uncontrolled shivering for almost an hour. I might have sought medical help if it wasn't so late at night. The symptoms subsided and I had no further incidents or any longer term effects.
breakthrough case of covid 19 after 2 doses of Pfizer Covid 19 vaccine more than 14 days prior to illness
Pt had imm. at HD at approx. 9:30. Within 1 hr she was crying inconsolably and continued to do so at her appt w/me at 3 pm same day. Mom had given TYLENOL which did not alter symptoms. Pt had high pitched scream.
9/21 - Site reaction - red, hot, swollen. Pt states she had same reaction last year, perhaps at pharmacy. Pt has taken BENADRYL and used cold compresses. 9/26 - pt. states swelling and redness much improved.
Tingling in lower extremities from the knee down. Tingling in fingers.  Pain in lower extremities. "Disconnected" feeling, did not feel like I usually do.
Rash, extremely itchy, first traveled up vein on right arm (thought maybe Shingles)-moved to both sides, small raised bumps, red patches, easily became inflamed and bled. 11/17/2015-Went to clinic at 3:30 PM-diagnosed as possible flu shot reaction-possible Eczema, given steroid shot and a course of oral steroids (started 4 for two day, then 3 for two days, etc.), told I should get relief from itching later that evening. 11/18/2015 through 11/24/2015 continued to itch and the rash spread from arms to torso and legs. 11/24/2015-Returned to clinic, diagnosed as allergic reaction to flu shot with an egg allergy, told I needed to watch how much egg I ate each day, given another round of oral steroids starting at 4/4, given Atarax.
Unresponsive episode 26 hours, post vax. Event lasted about 15 minutes.
Several weeks after my second dose of the Pfizer vaccine I began feeling in my upper arms a dull ache, and listlessness, and lack of strength.  It felt like the kind of muscle ache one gets when one has the flu.  Day by day the ache became greater in intensity, although never great enough to interfere with my daily routine, or to seek medical care for it.  The aching, listlessness, and lack of strength in my upper arms continued throughout June and into July, increasing with intensity day by day until the middle of July, when the symptoms began to wane.  At present, while not totally gone, the symptoms are much less than previously, and seem to be lessening with each passing day.
TOOK VIVOTIF THAT WAS STORED IN A REFRIGERATOR WITH FLUCTUATING TEMPERATURES; This spontaneous case (PVX2019-2274) was received form a pharmacist on 05-Sep-2019. It described an adult male consumer who "took Vivotif that was stored in a refrigerator with fluctuating temperatures" (PT: Product storage error), while being on oral Vivotif capsule (1 capsule by mouth every other day) for typhoid prophylaxis.  Case report: The consumer took Vivotif doses, which were stored in a refrigerator with fluctuating temperatures. She did not know the total duration of each excursion but informed that the maximum temperature reached was 55-degree Fahrenheit and the lowest was 35 degree Fahrenheit. Lot number remained unknown.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took Vivotif that was stored in a refrigerator with fluctuating temperatures" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif that was stored in a refrigerator with fluctuating temperatures" was considered as not applicable.
very dizzy; massive stroke; cascade of blood disorders and blood issues; cascade of organ issues; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (very dizzy), CEREBROVASCULAR ACCIDENT (massive stroke), BLOOD DISORDER (cascade of blood disorders and blood issues) and MULTI-ORGAN DISORDER (cascade of organ issues) in a 73-year-old male patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (very dizzy) (seriousness criterion hospitalization), CEREBROVASCULAR ACCIDENT (massive stroke) (seriousness criteria hospitalization and medically significant), BLOOD DISORDER (cascade of blood disorders and blood issues) (seriousness criterion hospitalization) and MULTI-ORGAN DISORDER (cascade of organ issues) (seriousness criteria hospitalization and medically significant). At the time of the report, DIZZINESS (very dizzy), CEREBROVASCULAR ACCIDENT (massive stroke), BLOOD DISORDER (cascade of blood disorders and blood issues) and MULTI-ORGAN DISORDER (cascade of organ issues) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Haemoglobin: decreased (Low) Decreased. On an unknown date, Oxygen saturation: decreased (Low) Decreased. On an unknown date, Platelet count: decreased (Low) decreased.         No concomitant medications were provided As reported, four days after after the second Moderna COVID-19 dose, he became very dizzy and had a massive stroke. He was in the ICU for 3 weeks. He had a cascade of blood disorders and blood issues and organ issues. His platelets, oxygen and hemoglobin were down. He received 2 transfusions to replace his red blood cells.  Company comment: This is a spontaneous case concerning a 73-year-old male patient with no medical history reported, who experienced the unexpected serious events of Dizziness, Cerebrovascular accident, Blood disorder and Multi-organ disorder four days after the second dose of mRNA-1273 vaccine. Rechallenge was not applicable. The patient's advanced age remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-445768, MOD-2022-445279, MOD-2022-447065 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 73-year-old male patient with no medical history reported, who experienced the unexpected serious events of Dizziness, Cerebrovascular accident, Blood disorder and Multi-organ disorder four days after the second dose of mRNA-1273 vaccine. Rechallenge was not applicable. The patient's advanced age remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This case was reported by a healthcare professional and described the occurrence of nonspecific reaction in an adult male subject who was vaccinated with HAVRIX adult (GlaxoSmithKline). On an unspecified date in 2009 the subject received unspecified dose of HAVRIX adult (unknown). In 2009, 2 days after vaccination with HAVRIX adult, the subject experienced nonspecific reaction. The subject had a reaction two days after receiving HAVRIX. The subject consulted a physician who believed the reaction was to "antibiotic in HAVRIX". The reported nurse believed that this occurred sometime last year (2009). At the time of the report no other details were provided. At the time of reporting the outcome of the event was unspecified. The nurse reported additional cases see A0882391A, A0882436A and previously reported A0797402A.
pt recv vax 21OCT96 & 2JUL97 pt mom reported 1JUL97 pt had a t102, woke up the following day w/red spots on lips, neck, chin, back & legs;chickenpox was subsequently confirmed by MD;pt recovered;
devel fever to 102 w/in hrs p/shot; extreme tenderness @ inject site; hallucinations w/fever; vomiting x 24 hrs; resolved in 3 days;
Red, swollen arm at area of injection, itchy.  Treated with ice compresses.  Lasted about one week.