chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My nervous system is a wreck; Have not slept in two days; My digestive system is unfix, I have gone to bathroom like 3 times yesterday; I feel like I wanted to throw up; discomfort; This is the spontaneous report from a contactable consumer (patient). An 86-year-old male patient received BNT162B2 (Pfizer vaccine; Lot number: unknown; Expiry date: Unknown), via an unspecified route of administration on 25Jan2021 as a single dose for COVID-19 immunization. Medical history included unspecified Diabetes. Concomitant medications included Losartan (unspecified dose) and Xarelto 20 mg. On 26Jan2021, patient experienced my nervous system is a wreck (nervous system disorder), I have not slept in two days (insomnia), my digestive system is unfix , I have gone to bathroom like 3 times yesterday(gastrointestinal disorder), I feel like I wanted to throw up (nausea), discomfort (discomfort) and I can't you know (incomplete sentence) and the patient was just trying to find out, how long this side effect would last approximately or what to do, to ease my discomfort. Therapeutic measures taken as a result of the events; Tylenol and patient regular medications were taken. The outcome of the events were not recovered.  No follow up attempts are possible. No further information is expected.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Headache, Myalgia, Diarrhea, Nausea Vomiting, Body aches, chills, headache, diarrhea, nausea,  emesis x 1
Patient stated he had a fever as high as 101.0 for about 18 hours. Severe incapacitaing joint pain in shoulders, elbows, lower back, and knees. Unable to make a fist.
Severe local reaction with redness, swelling and warmth of left lateral arm. No treatment needed and in 3 days it resolved completely.
He got his vaccine, in late December he had blood work which showed that his Multiple Myeloma that was in remission had come back, which was informed by his doctor that the vaccine stirred up his disease.  He got the Evusheld infusion and now has been started back on his chemo, does not know what is going on with his condition, waiting to see if the new chemo going to go back in remission.  He was told by his doctor not to get anymore vaccines.  They are coming out with a new treatment for multiple myeloma.  The first two vaccines increased his markers a little bit, but with the 3rd one it shot up and went crazy.    His Oncologist is Dr. at the Cancer Institute.  She is the one who said no more vaccines for him.
this information is regarding the twelfth of 12 patients that received expired FLUZONE QIV NP with no reported adverse event; Initial information was received on 15-Oct-2021 regarding an unsolicited valid non-serious case received by nurse via other healthcare professional via physician (under Agency Inquiry Number-00814579).  This case involves a 70 years old male patient who reported this information is regarding the twelfth of 12 patients that received expired fluzone qiv np with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were unknown.  On 15-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7108MA, expiry- 30-jun-2021) via intramuscular route in unknown administration site.  On 15-OCT-2021 the patient reported a this information is regarding the twelfth of 12 patients that received expired fluzone qiv np with no reported adverse event (expired product administered) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported "Nurse practitioner states that 12 patients have received FLUZONE QIV NP vaccines in her practice from 14OCT2021 to 15OCT2021 that expired on 30JUN2021. Caller asked how to proceed in this situation. Caller asked if there were any differences between the 2020 FLUZONE QIV NP vaccine and the 2021 FLUZONE QIV NP vaccine. See inquiries associated with this contact for additional patient information."  Relevant lab data was not reported.  Action taken with QUADRIVALENT INFLUENZA VACCINE was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  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.
Mother stated child received DTaP, Prevnar, Comvax and IPV. Child slept until he arrived home then had a blood curdling scream for 6 hrs. Fever as high as 102 with Tylenol fever and to normal by 2 a.m. Would not take bottle until next morning.
This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043AZ1A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the patient experienced trouble breathing, rush of chemicals going through arm, chest and neck, and felt arm pain. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from trouble breathing on APR-2021, and was recovering from felt arm pain, and rush of chemicals going through arm, chest and neck. This report was non-serious. This case is associated with product quality complaint (PQC): 90000214889. The suspected product quality complaint has been confirmed to be this report indicated a medical adverse event for the patient after the product was administered. There is no product quality issue described in the information reported. This record was approved as void as no PQC identified based on the PQC evaluation/investigation performed. Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
The pt experienced a seizure lasting 5 minutes one day post vax. Temperature in ER was 101.
Pallor, diaphoresis; cool and clammy; dizziness syncope; bradycardia; nausea and clear color emesis;  Vital signs :BP- 102/60; 118/78; 116/76 . P-60; 70;76. Resp-16-20 .O2 sats  100%.  treatment provide supine position elevation of lower extremities.   Cool pack to head and back of neck . Client asymptomatic upon release. Skilled instructions provide to refrain for use on influential substances , as well not to be under the influence with 2nd dose  appointment. Verbal understanding noted.
Pt states that upon leaving the store, roughly 15 minutes after recieving the vaccine, the patient felt a warm through her body as her husband was driving and she briefly lost consciousness.  She did not specify what medical treatment was sought after this event
My daughter became ill within a day or so of taking the H1N1 Flu mist.  She has overall body weakness, a cough and congestion.
Initial case was received on 24 June 2010 from a consumer who is also the patient. A 33 year old female patient received a left deltoid intramuscular injection of ADACEL (sanofi pasteur Ltd. lot number C3256, sanofi pasteur Inc. lot number U3035AA) on 10 May 2010. The patient "possibly" (patient unsure) experienced left orbital pain earlier in that day. One week after receiving the vaccine she experienced worsening eye pain, vision changes and approximately over two weeks, by 22 May 2010 the patient had no vision in left eye. She was treated with intravenous SOLU-MEDROL on an outpatient basis for three days. On unspecified dates, the patient had multiple tests performed including MRI, spinal tap and tests for autoimmune disorders with negative results. The patient had no pre-existing medical conditions, no known allergies and used no concomitant medications. She had no adverse event following prior vaccinations and had no other vaccinations within 4 weeks of the date of this vaccination. As of this report the pain was better and the vision remained blurry. Documents held by sender: None.
VACCINE AFFECTED HORRIBLY; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unknown, expiry: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced vaccine affected horribly. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine affected horribly was not reported. This report was non-serious.
Patient age 16 was administered Janssen (J&J) vaccine.  Janssen age limit is 18.
body aches, chills, fever, h/a, low back pain, out of work x2 days
Took 2 shots in same arm about 1/2" apart. I went home and laid down. About 4 hours, my arm began to swell. It (the place where shot was given) was about the size of a baseball. The next morning, about 07:30, my arm was about 3 times as big. Still have effects. Missing vaccine information not available.
itching in the hip area; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itching in the hip area) in a 42-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     It was reported that patient received other vaccines in the 4 weeks prior to COVID-19 Vaccine.  Concurrent medical conditions included Schizoaffective disorder (unspecified medication). Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    In September 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. In September 2022, the patient experienced PRURITUS (itching in the hip area). At the time of the report, PRURITUS (itching in the hip area) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Historical drug was reported as Fle. No treatment information was provided.
SWELLING AND REDNESS OF LEFT ARM WHERE VACCINE WAS GIVEN.  RESOLVING WITH RX.
Developed rash over body approx 4 days after received MMR and varicella vaccines. Persists off and on x 2 months. Seen by dermatologist. ? etiology
Symptoms: patient reported right arm numbness, difficulty moving right arm, blurred vision and difficulty speaking in full sentences - these occurred within 45 minutes of receiving the flu vaccine.  Treatment: neurology consultation, CT of head, MRI of brain and spine, IV fluids,  Benadryl IV, Compazine IV, lovenox subq., admission to hospital
had side effects from third Pfizer COVID Vaccine lasted 3 days; had side effects from third Pfizer COVID Vaccine lasted 3 days; had side effects from third Pfizer COVID Vaccine lasted 3 days; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 3, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 and dose 2 via an unspecified route of administration on an unspecified date for covid-19 immunisation. The patient reported had side effects from third Pfizer COVID Vaccine lasted 3 days and this was immune response to vaccine. No additional details provided. No additional information was provided.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Swelling, fever to 100.5, redness, pain increasing in severity, pain becoming all over body.
tested positive; spent the whole day yesterday with their Son. the son tested negative for Covid previously however he tested positive Today; tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, ID: (159558). The reporter is the patient.  A 91-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 91 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary vaccination series completed (Manufacturer unknown)), for Covid-19 immunization. The following information was reported: COVID-19 (medically significant) with onset 02May2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "tested positive"; EXPOSURE TO SARS-COV-2 (non-serious), outcome "unknown", described as "spent the whole day yesterday with their Son. the son tested negative for Covid previously however he tested positive Today". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02May2022) Positive.  Clinical information: Consumer and his wife on the line to say they have scheduled their second booster for Pfizer Covid-19 and they found out they tested positive today. This report is regarding reporter who is also patient. Caller clarified that he is scheduled to have his second booster of Pfizer Covid-19 later this afternoon at the pharmacy. Caller verified that he tested positive today, 02May2022. Caller was talking to his son today; his son spent the whole day with reporter and wife on 01May2022 and last night on 01May2022 his son tested again and was positive. Caller is very elderly; he is in his 90s. He just wants a yes or no of should they go to the appointment for the second booster today or take a rest, wait first relative to testing positive  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-202200650625 same reporter/drug/AE with different patient
Administration site with vesicular lesions and circular erythematous tender and generalized erythematous papular trunk, extremities.
left side of his tongue started to itch; tongue slightly swollen; lips got swollen as well on both sides near the edges; pain on arm; swelling of the tongue and mouth; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE PRURITUS (left side of his tongue started to itch), SWOLLEN TONGUE (tongue slightly swollen), LIP SWELLING (lips got swollen as well on both sides near the edges), PAIN IN EXTREMITY (pain on arm) and MOUTH SWELLING (swelling of the tongue and mouth) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma since an unknown date. Concurrent medical conditions included Seasonal allergy, Food allergy (all diary products, nuts and fish) and Drug allergy (Demerol allergy). Concomitant products included OLOPATADINE HYDROCHLORIDE for Nasal congestion, FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Seasonal allergy.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced TONGUE PRURITUS (left side of his tongue started to itch), SWOLLEN TONGUE (tongue slightly swollen), LIP SWELLING (lips got swollen as well on both sides near the edges), PAIN IN EXTREMITY (pain on arm), MOUTH SWELLING (swelling of the tongue and mouth) and FATIGUE (fatigued). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 05-Apr-2021, SWOLLEN TONGUE (tongue slightly swollen), PAIN IN EXTREMITY (pain on arm) and MOUTH SWELLING (swelling of the tongue and mouth) had resolved, LIP SWELLING (lips got swollen as well on both sides near the edges) outcome was unknown. At the time of the report, TONGUE PRURITUS (left side of his tongue started to itch) and FATIGUE (fatigued) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, SARS-CoV-2 antibody test: positive (Positive) SARS-CoV-2 antibody test-Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient has an EpiPen that takes everywhere. For the symptoms,patient took Benadryl the day of the vaccine. Patient received treatment of Tylenol the next day for the sore arm.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (dose, route of administration, lot# and expiration date were not reported), which were reconstituted with properly stored sterile diluent (STERILE DILUENT). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion (temperature and time frame were unspecified). A Digital Data Logger was involved. There were many multiple previous temperature excursions reported. This is one of two reports received from the same reporter. Additional information is not expected, as there was no consent to contact the reporter. Sender's Comments: US-009507513-1705USA005731.
On 08/18/2021 the night of the vaccination, severe body aches, fever, headache short of breath.  My oxygen stats were 88 to 92 those 48 hrs. I had to wear my oxygen continuously. I had temperature of 102 and severe headaches and severe body aches. All the symptoms lasted about 48 hours.  On 08/19/2021 I called my doctor-  prescribed Solucortex injection because  I was having a lot of trouble breathing, and coughing, and started a high taper of the  Prednisone.
After the last shot I started losing my hearing,With hearing loss, Patient now disabled and unable to work.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (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), for COVID-19 immunization; Bnt162b2 (Dose: 2), for COVID-19 immunization. The following information was reported: DEAFNESS (disability, medically significant), outcome "unknown", described as "After the last shot I started losing my hearing,With hearing loss, Patient now disabled and unable to work.".  Clinical course includes, customer Verbatim: Patient had three shots of Pfizer vaccine to prevent coronavirus. After the last shot patient started losing hearing. Patient then had a fourth shot and hearing got worse. Patient wrote please do more research on vaccine. With hearing loss, Patient now disabled and unable to work. It is a big loss and before it happens to someone else hoping the issue gets resolved.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Persistent dry cough - through the night (would wake her) and through the day. Set of coughs ~every 5-10 minutes during the day. It seems to be better at night now - not waking her and only a few coughs heard (before we are sleeping and don't hear her). Taking Respiguard Glycerile plus Elderberry (2 droppers/day)and Ledum Palustre (2/day) for a week to see if cough improves.
3-4 hrs p/vax pt devel red blotches around eyes, face & upper body; t100; APAP given 30 mins p/vax;
Dizziness, lighthead,  short period of rapid heartbeat reported within 1 minute of the immunization. NO shortness of breathe, NO hive, NO rash, NO itching. Symptoms resolved within 5-10 minutes
Allergies like reddish with itchiness rashes; Allergies like reddish with itchiness rashes; Allergies like reddish with itchiness rashes; Allergies like reddish with itchiness rashes; This is a spontaneous report from a contactable consumer received from a Pfizer Sponsored Program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on 08Mar2021 as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, the caller, (name withheld) called to ask whether she needs to continue taking Zyrtec 10 mg for allergy and to ask about an outdoor immune suppressor medication she heard about. According to (name withheld), she had her first dose of the covid-19 vaccine on 08Mar2021 and since then she had been taking anti-allergy (Zyrtec tablet 10 mg) and stopped, about 2 or 3 days ago, on an unspecified date in Mar2021, she had some allergies like reddish with itchiness rashes after stopping in taking Zyrtec 10 mg 2 or 3 days ago also. In addition, (name withheld) second dose was scheduled on 30Mar2021. Any unaddressed medical questions referred or forwarded to Medical Information was reported as no. The outcome of the events was unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Patient report approx. 3-4 hrs after having received his first dose of Ixiaro IM in his lt deltoid he started having constant, sharp pain radiates from above ankle to LT groin. Saw Pt on 6-4-13 leg pain persists. Able to have full weight-bearing. + limping w/ambulation d/t pain. Lt pedal pulse +3. No edema/erythema/overt signs of lt leg injuries during this visit. Full ROM of lt leg. Pt denied hx of sciatica or past back injuries.
Patient's age is unauthorized to receive the vaccine but was given the first dose of the vaccine. No adverse reactions.
Fever, delirium, unable to control body temperature, searing headache, pervasive, unrelenting nausea,
Pt recevied MMR, Varivax 04/15/05- presentd with rash of erythema multiforme. 04/28/05 an Urgent Care clinic and was seen here. Recovering.
R eye blood shot then swollen almost closed 20 min after injection, then left eye swelled to almost closing took 25mg Benadryl, symptoms lessened but didn't disappear. 6 hrs after injection whole body covered with hives-took 25mg Benadryl again. Symptoms resolved by the following morning. Will have visit with allergist for testing.
per patient phone call 3/3/2021@                                   3:54pm  " feeling terrible. never been so sick, could barely pick up phone"
SLIGHT URTICARIA BEGINNING 4/15/19 & WORSENING AROUND 0400 4/16/19