chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had two influenza vaccines this season with no reported adverse event; Initial information was regarding an unsolicited valid non serious case was received from a pharmacist via  Medical Information (Reference number- 00839292) and transmitted to Sanofi on 02-Nov-2021 in a specific country.  This case involves a 73-year-old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (extra dose administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On 02-Nov-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ732AA, expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error due to extra dose administered. (latency: same day).  It was reported Pharmacist reports consumer had two influenza vaccines this season.  At time of reporting, no adverse event 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.
Headache Right Temple, Comes and Goes; Shooting Muscle and Joint Pains; hit foot and thigh, random, not everyday, not 24/7; Tiredness; Shooting Muscle and Joint Pains; hit foot and thigh, random, not everyday, not 24/7; Left Arm Pain, Swelling and Itching; Arm felt like Lead / Arm Sore; Left Arm Pain, Swelling and Itching; Arm felt like Lead / Arm Sore; Left Arm Pain, Swelling and Itching; Arm felt like Lead / Arm Sore; Pain and Burning at Injection Site During Injection; States it was red but no rash; 14Apr2021; tiredness, shooting muscle and joint pains; hit foot and thigh, random, not everyday, not 24/7, left arm pain, swelling and itching; arm felt like lead since 15Apr2021; headache right temple, comes and goes since 21Apr2021. The patient reported that she still had some of the side effects from her second vaccine on 14Apr2021. She was not sick but she still had the tiredness. She could do her shopping and errands but when she gets home, she wanted to relax and lay down, then she would get up and cook dinner. Stated the swelling and all that left, she was just still tired and she got shooting muscle joint pains. She did have itching on her arm and it felt like lead for 4 days. States it was red but no rash. Every now and then she got a slight headache. It had been about a week and a day now, she wanted to know if that was still normal to still be having these side effects. Patient stated with the second injection, it did burn going in. Stated with her first shot, no pain whatsoever. Stated she asked the lady will this be a small needle. Stated she said yes, and it hurt and burned when she gave it to her. States the only thing she thought was maybe it was because she wiped her arm with alcohol and didn't wait long enough on it to dry. Stated her friend that is a nurse told her to move her arm around to help that pain so she started moving it around and it did help some. AE(s) did not require a visit to Emergency Room or Physician Office. Reported that it wasn't that kind of sickness. She had read that this was normal, just wondering if a week out, is it still normal. The patient did not receive any treatment for the events. Outcome of the events pain and burning at injection site during injection was recovered on 14Apr2021; left arm pain, swelling and itching was recovered on 21Apr2021; redness was unknown; other events was not recovered.  No follow-up attempts are needed. No further information is expected
Patient experienced tinnitus, cold feeling, paleness, and lightheadedness (described by her like she felt like she was going to faint but she never progressed to an actual syncopal episode).  All experienced within 5 minutes of receiving vaccine.  Tinnitus resolved within 10 minutes.  Lightheadedness and cold feeling continued to improve and resolved within 20 minutes.
Discovered 2 red,itchy spots upper right abdomen.  12/03/09 7AM both groin areas itchy.  8AM lower left back of neck was red, itchy, and sore.  3PM found red, itchy, sore on outside of left knee. 3PM Pt called Dr. who prescribed Valtrex x 7days.  Took 1st dose at 4PM.  12/04/09 Continued with Valtrex, itching was not as intense.   No new spots after 9PM.
Started with hives/rash at waist line which gradually moved up his side that evening. By the next morning, the rash had spread over his entire body. Pt went to the Er and was given epi, Zyrtec, prednisone. No previous reactions to drugs or vaccines.
This spontaneous report was received from a Registered nurse regarding a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
3 days after I got the first COVID-19 Vaccine shot, I started to have itching in the area plus area is a little swollen.
Mom reports at 2 mo. WCC, pt cried uncontrollably for 2+ hours after being given the DTaP. At his 4 mo. WCC she reported 4+ hours pt uncontrollable crying as well as low-grade fever, pulling legs into chest with the DTAP. We held off DTAP today and pt is tolerating all other shots normally. 8/22/16.
shingles; other zoster-related conditions; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 01-MAY-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by health care providers for shingles and other zoster-related conditions. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles and other zoster-related conditions was not recovered. The causality assessment was considered as related by the lawyer.
Patient's medical records from system indicate patient had muscle aches, cough, shortness of breath, fatigue, difficulty breathing.  Patient is reported to have acute respiratory distress and had developed pneumonia.
This spontaneous report was received from a consumer concerning a 19 year old female patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date, reported as at the age of 18 years old, the patient was vaccinated with the first dose of GARDASIL 9 as prophylaxis. One year later on an unknown date, at 19 years old, the patient received the second dose of GARDASIL 9 as prophylaxis. (Strength, dose, lot numbers, expiration dates and route of administration were not reported). No adverse effect was reported. Additional information is not expected because contact details were not provided.
This case was reported by a nurse via call center representative and described the occurrence of  headache in a 17-year-old female patient who received BEXSERO (batch number 156701, expiry date 21st AUGUST 2017). On 8th SEPTEMBER 2016, the patient received the 1st dose of BEXSERO, .5ml. On 9th SEPTEMBER 2016, 1 days after receiving BEXSERO the patient experienced headache and general body pain. On an unknown date, the outcome of the headache and general body pain were not recovered/not resolved. The reporter considered the headache and general body pain to be related to BEXSERO. Additional details were provided as follows: Nurse reported that the patient experienced severe body ache and headache after receiving BEXSERO vaccine and she had also missed her school. At the end of the call, the nurse reported that "this" had happened before with other patients, but had not been reported. She did not explain what "this" was nor did nurse give details of how or which patients experienced an event. The case has been linked to case US2016132125, reported by the same reporter.
No adverse event; accidentally gave a booster dose before the patient completed the primary series; greater than 36 days since first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (accidentally gave a booster dose before the patient completed the primary series), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 36 days since first dose) and NO ADVERSE EVENT (No adverse event) in a 63-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 36 days since first dose). On 20-Oct-2022, the patient experienced INCORRECT DOSE ADMINISTERED (accidentally gave a booster dose before the patient completed the primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (accidentally gave a booster dose before the patient completed the primary series), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 36 days since first dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INCORRECT DOSE ADMINISTERED (accidentally gave a booster dose before the patient completed the primary series) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 36 days since first dose).    No Concomitant medications were provided. It was reported that pharmacist was calling because they accidentally gave a booster dose before the patient completed the primary series. The patient received first dose of Moderna on 17 Mar 2021. No treatment medications were provided.
no adverse event; Expired vaccine that was administered to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine that was administered to patients) and NO ADVERSE EVENT (no adverse event) in a 70-year-old male patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine that was administered to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine that was administered to patients) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine that was administered to patients).    No concomitant medications were reported.  Patient's age was reported as 70 Year 9 Month.  The ID was reported as 80777027399.  Person number was reported as 160611.  The vaccine from the vial with lot number O70H21A was administered to the patient in between a period of 08-Apr-2022 to 15-Dec-2022.  No treatment medications were reported.
Chronic reoccurring skin rash with inflammation, also with systemic inflammation. Prescribed topical steroid for rash. Still suffering since given vaccine. Debilitating, some days hard to work, wear clothes. Still use steroid cream occasionally.
Patient developed significant watery diarrhea that lasted for 3 weeks shortly after 3rd dose of Rotateq (began 4 days after vax)
had dr appt in Feb her heart was fine and after 2nd dr appt in Aug. her dr told her she had a weakened heart muscle which occured after she took the 2nd vaccine
arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004c21A) for COVID-19 vaccination.     Concomitant products included BUSPIRONE for Anxiety, TAMSULOSIN for BPH, BENAZEPRIL and AMLODIPINE for Blood pressure, ATORVASTATIN CALCIUM (ATORVASTAN) for Cholesterol, ESCITALOPRAM OXALATE (ESCITALOPRAM +PHARMA) for Depression.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced PAIN IN EXTREMITY (arm soreness). At the time of the report, PAIN IN EXTREMITY (arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
(L) arm/deltoid 5x6 cm area swelling/redness/increased warmth. No streaking/ no fever. Rx'd with KEFLEX.
Hives about 6 hours after Menactra to ER Prednisone RF
Patient contracted COVID after being fully vaccinated.  No booster. Headache, fatigue, fever, cough, congestion, runny nose.
I got the shot yesterday (4/15/21) and started feeling extreme shooting/stabbing pain in my arm roughly 4 hours later.   I'm now unable to move my arm in any way without experiencing intense pain. My arm feels very stiff as well.
SICK FOR DAYS; FELT LIKE BRAIN WAS ON FIRE; CHILLS; FEVER; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced sick for days, felt like brain was on fire, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sick for days, fever, chills and felt like brain was on fire was not reported. This report was non-serious.
Rash on vaccine arm began possibly March 23 , vaccine given March 12. Described by patient as hot to the touch but not itchy
p/vax pt had upset stomach & vomiting;had gone to be fine the noc of inj  but woke up early w/nausea & vomiting;
Sleepy and weakness.  Drunk like sx at 1900 hr.  Currently very tired.  Steady gait.
Pt with longstanding co-morbidities. Had routine phlebotomy today. It was noted during phleb O2 sat low and BP was elevated. Pt was not wearing O2 and it is ordered for day and night use.  He does not wear his O2 as ordered. O2 was placed during remainder of appt.  Will f/u with provider.
The arm is sore, red, itchy, hard, and has a lump. The whole arm per employee feels swollen and tight. Metallic taste that comes and goes. Very tired. Numbness on the left arm.
developed arm rash on the 6th day after my first covid vaccine  shot, and still have it,  it has now spread from upper arm to shoulder and down to the middle of forearm, my Doctor prescribed Methylprednisolone (4mg) . No one can answer if I should get the second shot or not. I just do not know what to do, or wait and take this medications after I get the second dose?  Can someone please inform me as to what to do
My menstrual cycle started early and lasted two weeks longer than it normally does.  My cycle is always very regular, so this change was very noticeable.  My cycle normally lasts 5-6 days, and it lasted almost 3 weeks after my first dose.
flushed face, shortness of breath, feeling like I was going to pass out, tightness in my throat but could still swallow, had heart palpitations and feeling like my heart was going to come out of my chest.  Those symptoms lasted for about 5-10 minuets and slowly the flushed feeling went away and heart stopped racing after about 10 min. I was very shaky and still had a bit of tightness in my throat.  I left the area out 40min but was still very jittery.  Currently its 1510 and I still have some localized flush feeling in my cheeks and continued jitteriness but am breathing fine.
Did not have a reaction to vaccine but did test positive for COVID on 09/07/2021.
I had a shock of pain, I was dying of pain.; This is a spontaneous report from a non-contactable consumer reporting for herself.  A 28-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on Apr2021 at 13:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation  .  The patient medical history  and concomitant medications were not reported.  The patient  had a shock of pain, was dying of pain. The reported event was considered serious because Important Medical Event.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe headache, n/v, neck pain, high blood pressure. Lasted almost 4 weeks, had 6 ED visits and 3 hospital admissions. The only thing that helped was IV steroids.
fever of 100 degrees; chills; muscle ache; joint ache; injection site pain; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ENT6204), via an unspecified route of administration in left arm on 04Mar2021 at 10:45 as dose 1, single for COVID-19 immunisation at public health clinic/veteran's administration facility. Medical history included depression from an unknown date and unknown if ongoing, hospitalized for COVID-19 on an unknown date in Dec2020 to an unknown date (This feels exactly like the real thing). Concomitant medications included fluoxetine hydrochloride (PROZAC) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient had COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Mar2021 at 12:00, the patient experienced fever of 100 degrees, chills, muscle ache, joint ache, injection site pain. with outcome of not recovered. The patient underwent lab tests and procedures which included fever was 100 degrees on an unknown date. The patient did not receive any treatment for the events. The outcome of the events was reported as not resolved.  No follow-up attempts are possible. No further information is expected.
02/14/22, 14:20 tightness in upper chest, 18:17 tightness in upper chest; 02/15 full body aching joints entire day including spine, took Tylenol 325mg every 3 hours, 22:47 right lymph nodes swelling throughout front & underside of armpit - closest to injection site. 2/16 iced armpit and Tylenol 325mg every 3 hours.
This is a spontaneous report from a contactable Nurse via Pfizer sales representative. A 17-years-old patient of an unspecified gender received the first dose of TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced rash on an unspecified date with outcome of unknown. Information on the batch number has been requested.
Patient was given vaccination in the left deltoid muscle. The following am she had significant swelling in the left arm & hand below the injection site. The swelling is gradually subsiding.
Patient presented with a painful erythematous macular/patchy rash on bilateral lower extremities from knees down. Peeling skin on plantar surface both feet. Positive fever. Discharge summary states tinnitis pedis, pain. msv
Symptomatic Covid 19 Infection confirmed by at home test.; Symptomatic Covid 19 Infection confirmed by at home test.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 12Oct2022 as dose 4 (booster), single (Lot number: EL3248) at the age of 46 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Psoriatric Arthritis" (unspecified if ongoing); "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jun2023 at 15:00, outcome "recovering" and all described as "Symptomatic Covid 19 Infection confirmed by at home test.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jun2023) Positive, notes: at 15:00 Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was treated with PAXLOVID.
This spontaneous report was received from a pharmacist refers to an adolescent patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy were unknown. On an unknown date, it was reported that the patient was vaccinated with second dose of VAQTA (strength, units, lot and expiration date unknown) on "2 months after first dose of VAQTA. No adverse effects were reported. There was no product quality complaint (PQC) reported.