chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flublok: was given to a 16 or 17 year old patient / no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves unknown gender patient (16 or 17 year old) who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number and Expiry date unknown) via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to inappropriate age at vaccine administration.  It was reported that Flublok was given to a 16 or 17 year old patient.  At the time of reporting no adverse reaction 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 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.  Information on the batch number was requested.
Now right side paralysis. Events started as spasms in back, shoulder and neck both arms. Hospitalization and pt also sick at home for at 2 wks right after vaccine.
pain, swelling and redness at injection cite x 2 weeks. Fever and chills x3 days after injection .
There have been many effects but the main ones include persistent back pain and my hair started falling out after my hepatitis B shot.  I have a bald spot and my hair has thinned out severely.  There have been many articles linking the hepatitis b vaccine to alopecia areata.  Additionally, I had rashes that developed on 2 places in my body, one near the injection site and one on my knee.
On approximately 6/11/2003, pt had fever of up to 102.5 degrees afternoons for 1 week, then felt "weak" for 1 week, with a dry mouth. He has since recovered.
Delay of the menstrual cycle by 9 days.  I also had a delay of my menstrual cycle with vaccine number 1 of 15 days late. My menstrual cycle is an average of 29 days with these outliers included but prior to these covid vaccines, my cycles were averaging fewer than 28 days.  It may seem small but in 2 of 3 of my cycles following my vaccines I have had a dramatic shift in cycle length.  It did not change the bleeding duration and appears to return to a normal 26-29 day cycle.
MYOCARDITIS; This spontaneous report was received from literature. This report concerned a 28 year old male of unspecified race and ethnic origin. The objective of this study was to better understand the characteristics and outcomes of the COVID-19 vaccine-related myocarditis. 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, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced myocarditis. Laboratory data (dates unspecified) included: Peak Cardiac troponin I (NR: not provided) 17.08 ng/mL, and Left ventricular ejection fraction (NR: not provided) 50 %. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from myocarditis in 2 days. This analysis showed that myocarditis related to COVID-19 vaccine has an overall fast recovery with no short-term complications. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220303900-COVID-19 VACCINE Ad26.COV2.S-Myocarditis.The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Pt complained of itching and burning on L upper arm, dizziness after vaccination. Pt reported she did take 50 mg diphenhydramine before coming to vaccine clinic. Symptoms resolved.
sore arm; fever; chills; headache; nausea; every joint in body hurt; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172), via an unspecified route of administration in the right arm on 28Apr2021 at 11:30 (at the age of 64-year-old), as a single dose for COVID-19 immunisation. Medical history included COPD (Chronic obstructive pulmonary disease). Concomitant medications included metoprolol succinate (TOPROL XL 25 milligrams). The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150), via an unspecified route of administration in the right arm on 30Mar2021 at 11:30 (at the age of 64-year-old), as a single dose for COVID-19 immunisation and experienced sore arm on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, on the second dose the patient experienced sore arm again but also had a fever, chills, headache, nausea and every joint in the body hurt. The clinical outcome of the events sore arm, fever, chills, headache, nausea and every joint in the body hurt was resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
3/26/21: fever (around 99.1-99.9), chills, intense body pain, headache 3/27/21: low fever, body pain, headache, exhaustion 3/28/21: body pain and chills, headache, exhaustion 3/29/21: dizzy spells, exhaustion
pt recvd vax & temp as high as 104 would occasionally jerk, run temp for 1wk temp did drop several days later shot was recvd;
My arm muscle just started, like I tore something, and it hurt and it's sore; My right hip is so hurt so bad and is so sore; Don't feel good; This is a Spontaneous Report from a contactable consumer (patient). A patient of an unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 18Feb2021 as single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) for COVID-19 immunization. On an unspecified date in 2021 patient stated that "I had my second vaccine last Thursday on the 18Feb2021. 2 days ago Sunday, I had a reaction. I guess, I didn't think it was a reaction, I was doing something and suddenly my arm muscle just started, like I tore something, and it hurt and it's sore but I didn't take anything about it. Today I got up and my right hip is so hurt so bad and is so sore that I have to use support to walk. Then I also just don't feel good. Outcome of events was unknown.  Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Erectile dysfunction; This spontaneous case was reported by a consumer and describes the occurrence of ERECTILE DYSFUNCTION (Erectile dysfunction) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A and 091D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced ERECTILE DYSFUNCTION (Erectile dysfunction) (seriousness criterion medically significant). At the time of the report, ERECTILE DYSFUNCTION (Erectile dysfunction) outcome was unknown.            No concomitant medications were reported. No treatment information was provided by the reporter.  Two months after the second shot, patient started having erectile dysfunction. Patient wanted to know the incidence of this side effect. Patient was not seen by the doctor for this, but an appointment was made.  Both doses were injected into the upper arm.  Company comment: This case concerns a 26-year-old male patient with no medical history provided who experienced serious unexpected event of Erectile dysfunction. The event occurred approximately two months after the second dose of the mRNA-1273 vaccine. At the time of the report, the outcome of the event was unknown and no information regarding the clinical course of the event was provided. No information regarding patient's medical history, concomitant medications nor treatment medications was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 26-year-old male patient with no medical history provided who experienced serious unexpected event of Erectile dysfunction. The event occurred approximately two months after the second dose of the mRNA-1273 vaccine. At the time of the report, the outcome of the event was unknown and no information regarding the clinical course of the event was provided. No information regarding patient's medical history, concomitant medications nor treatment medications was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Felt immediate burning near injection site as the shot was given.  After about 8-10 minutes of sitting - burning (closest thing I've ever experienced is the burning sensation when given dye in IV before a catscan) radiated throughout my chest from my heart, rapid breathing, tongue started to go numb. One of the personnel noticed I was having difficulties and asked if I was okay when I said I thought I was a having a reaction I was asked to sit near her while they contacted a doctor to order a benadryl shot (not sure of the dosage). The doctor observed me and gave the okay to get the shot which was given in my upper right arm. After sitting for another 15 minutes or so I was able to leave the facility, but advised to go straight home as the benadryl shot would make me tired.
pt c/o itching @ site & devel hives over arm & trunk 1hr post immun;pvt MD notified & told mom to give DPH;no further problems reported;
Arm pain; red spot on my arm (size of a dime) where they injected the shot (left arm),; little sore; A spontaneous report was received from a consumer concerning a -female patient of unknown age,who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain in arm,vaccination site erythema and vaccination site pain. The patient's medical history was not provided.No relevant concomitant medications were reported.   On 7-jan-2021,prior to the onset of the events, the patient received their planned dose of mRNA-1273 (lot/batch unknown) intramuscularly on left arm for prophylaxis of COVID-19 infection.   On 17-jan-2021,the patient experienced a red spot on arm (size of a dime) where they injected the shot (left arm) and a little sore. No laboratory data was provided.Treatment information was not provided.  Action taken with mRNA-1273 in response to the events  was unknown. The outcome of the events pain in arm,vaccination site erythema and vaccination site pain was considered as not resolved at the time of the report.
still in bed; She couldn't eat, couldn't get up, couldn't do anything; very very sick; chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very very sick), BEDRIDDEN (still in bed), FATIGUE (She couldn't eat, couldn't get up, couldn't do anything) and CHILLS (chills) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. D29L20A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced CHILLS (chills). On 24-Feb-2021, the patient experienced ILLNESS (very very sick). On 01-Mar-2021, the patient experienced FATIGUE (She couldn't eat, couldn't get up, couldn't do anything). On an unknown date, the patient experienced BEDRIDDEN (still in bed). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK, q4h. At the time of the report, ILLNESS (very very sick), BEDRIDDEN (still in bed), FATIGUE (She couldn't eat, couldn't get up, couldn't do anything) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
3 BLOOD CLOTS IN LUNGS; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnic origin. 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 was not reported batch: unknown, expiry: unknown) dose was not reported,1 total, administered on an unspecified date for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced 3 blood clots in lungs. On an unspecified date patient was hospitalized for unspecified days. Patient was going to intensive care for two weeks.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 3 blood clots in lungs was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220434245-covid-19 vaccine ad26.cov2.s-3 blood clots in lungs . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
WBC 1.7/WBC 2.9; Hgb 11.5; ANC 0.1/ANC 0.6; This is a spontaneous report from a contactable physician reported for male patient. A 76-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection Batch/Lot number was not reported) via an unspecified route of administration (Age at vaccination: 76 Years) on 24Jan2021 as dose 2, single for COVID-19 immunisation. Medical history included Grade 3A Follicular Non-Hodgkin lymphoma from an unknown date and unknown if ongoing, stage III CKD from an unknown date and unknown if ongoing, benign prostatic hyperplasia from an unknown date and unknown if ongoing, abnormal LFTs from an unknown date and unknown if ongoing, Follicular NHL, Stage IV from Jun2020 to an unknown date, had Bendamustine/Rituxan x 4, began Rituxan maintenance in 21Oct2020 and last given in Dec2020. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 on 24Dec2020 for COVID-19 immunisation. The patient received any other vaccines within 4 weeks prior to the COVID vaccine was unknown. The patient received other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Feb2021, the patient experienced wbc 1.7/wbc 2.9, hgb 11.5, anc 0.1/anc 0.6. He had not received growth factors and had no symptoms from the immunization. The patient underwent lab tests and procedures which included haemoglobin resulted as 10.1 on 11Dec2020, 11.5 on 05Feb2021, neutrophil count resulted as 3.0 on 11Dec2020, 0.1 on 05Feb2021, neutrophil count resulted as 0.6 on 08Feb2021, platelet count resulted as 197 on 11Dec2020, 156 on 05Feb2021, white blood cell count resulted as 3.8 on 11Dec2020, 1.7 on 05Feb2021, 2.9 on 08Feb2021. No treatment received for the adverse event. The clinical outcome of the event was resolving.  Information on the lot/batch number has been requested.  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.
1st dose in Feb-2020, 2nd dose in Apr-2022; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in February 2020).   In April 2022, the patient received the 2nd dose of Shingrix. In April 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 20-APR-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient reported that he/she took the first dose of Shingrix and the second dose in April 2022 and enquired if he/she need a third dose. Additional Supportive Information: The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule The follow-up would not possible as no contact details were available.
Headache; Muscle pain; Joint pain; Chills; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 26Apr2021 at 07:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. On 26Apr2021 at 07:00, the patient experienced headache, muscle pain, joint pain, and chills. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events headache, muscle pain, joint pain, and chills were recovered on an unknown date in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is excepted.
PATIENT 17 YO AT TIME OF VACCINATION. J&J IS APPROVED FOR 18 YO AND UP.
This is a 91-year-old female who presented to emergency room with complaints of weakness and fatigue.  She was admitted on 514 and discharged on 517 and got down had a UTI and dehydration and confusion.  She had a painful rash on her chest she has multiple sclerosis and is bedbound and has multiple bedsores and was followed by wound care.  Her white blood cell count was elevated at 12.8 CT chest abdomen and pelvis was done which showed bilateral lower lung atelectasis and small left-sided pleural effusion and COVID test was negative urinalysis was negative sed rate was high  She was on antibiotic for 10 days and ran out and has had diarrhea for 3 days.  Ever since she fell a couple months ago she has not been able to transfer to a chair and has been completely bedridden.
dose 1 of Shngrix on 09/24/2018 and no 2nd dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 24th September 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter stated that, no lot number or expiry date available at the moment. The reporter consented to follow up.
Pt received Hep B vaccine on 9/4/08 and rash all over on 9/5/08. Pt did not report rash to us until 9/11/08. Pt states she has been taking Benadryl and rash is almost gone. Pt states she is also allergic to latex. Blood drawn for immune status. Pt states she had Hep B shot years ago with no problems.
CHILLS; LOSS OF APPETITE; DIZZINESS; TIREDNESS; MUSCLE ACHE; WEAKNESS; PAIN IN ARM; VOMITING; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 61 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: 1808982, 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 patient experienced nausea, fever. On 10-APR-2021 the patient experienced tiredness,  weakness,  muscle ache, vomiting, dizziness, pain in arm. On 11-APR-2021, the patient experienced loss of appetite and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 10-APR-2021, and dizziness on 11-APR-2021, was recovering from nausea, and pain in arm, and had not recovered from fever, weakness, muscle ache, loss of appetite, chills, and tiredness. This report was non-serious.
Information has been received from a health professional concerning a pt who was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine and had a local reaction. No other information was provided. Additional information is not expected.
Injection site itchiness redness very hot painful hard lump the size of a large grape. Very hard and painful
pt recv vax 30MAY96 & awoke 31MAY96 w/t102;mom gave APAP q 4 hr but temp 3PM was 103;seen by FMD & mom said no infect noted;no cold sx maybe virus & put pt on ATB;31MAY96 8PM t105 R;pt fussy;
Pt. reports no symptoms; on 3/3/22 became unresponsive related to diabetes, went to ED hospital, admitted and tested postivie for COVID