chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Myocarditis; pt developed Sx of HF; leg edema; SOB; EF 40%; This is a spontaneous report from a contactable physician. A 51-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on Apr2021 (at the age of 51-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination and adverse events. The patient previously received the first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: Unknown) on an unspecified date (at the age of 51-years-old) for COVID-19 immunization. It was reported that on Jun2021, the patient developed Sx (symptom) of HF (heart failure) with sob (shortness of breath) and leg edema; had echo done showing EF 40%. The physician sent the patient for cardiac MRI (magnetic resonance imaging) which showed findings c/w (consistent with) myocarditis; she had CCTA (coronary computed tomography angiography) done showing normal coronaries. She denied any history of cold or URI (upper respiratory infection) Sx. Second dose of vaccine was received on Apr2021 and symptoms started 6-8 weeks after. Therapeutic measures were received as a result of the adverse events. Corrective treatment included: Lasix, toprol, lisinopril, echo, venous duplex, cardiac MRI, labs, CCTA. Outcome of the events was recovering. The events resulted into a Doctor or other healthcare professional office/clinic visit. Since the vaccination, has the patient has not been tested for COVID-19.   Information on batch number has been requested.; Sender's Comments: Based on the available information in the case, the causal association between the events myocarditis, cardiac failure and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Child awakened from nap on 9/29/04; unable to move legs and difficulty moving arms, wincing in pain. Evaluation in ER revealed fever 101.7 with subsequent regression post Motrin of most of symptoms. 9/30/04 Pain linked to injection site.
Post vaccination - c/o numbness & pain (L) lower back, chills, itchiness in throat, hives. Epinephrine administered x 1. 911 activated - transported to hospital.
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated date was vaccinated orally with a third dose of ROTATEQ vaccine live (human-bovine) two weeks too late. It was reported that instead of the vaccine being given after 32 weeks it was given after 34 weeks. There were no adverse effects reported. At the time of the report  the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested.
Heplisav-B as 1st Dose and Then Energix as 2nd Dose A Month Later; Initial Report Received on 31-OCT-2022  This is a spontaneous report, received from a pharmacist regarding a female patient, aged 69 years, who received HEPLISAV-B for hepatitis B immunization.   There was no medical history reported.  Concomitant medications were not reported.  On 02-AUG-2022, dose 1 of HEPLISAV B (Lot #937229, expiration date 03-SEP-2023, NDC # not reported), intramuscular in the left deltoid for hepatitis B immunization.   On 12-SEP-2022, 41 days after having been vaccinated with HEPLISAV B, the patient was vaccinated with Engerix as a second dose in the left deltoid.  No adverse events were reported.  No further information was available at the time of the report. The reporter did not want to be contacted for additional information.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
pt recvd vax 24OCT95 1030AM lt deltoid;3Pm rxn to shot lump size of circumference of orange w/redness;4PM 25OCT95 call again no change in size;recommendation DPH q 8hrs ice packs;swelling progressed throughout arm;swelling, erythema, inc T
"2 Days after flu shot developed severe congestion in chest. For 2 weeks experienced malaise, chills, sweats and congestion grew worse. After 2 weeks acute symptoms disappeared but severe coughing remained with production of white mucous. 4th week saw doctor and lungs were clearing but was found to have an atrial flutter.  Being treated for that.
Dizziness, muscle pain and stiffness. Aching in legs (like when my back was out),nausea,joint pain , posterior thoracic pain
I experienced a very sore arm, which was swollen and painful to touch.  In addition, I felt some lethargy. These symptoms lasted 36 hours.
This case was received on 09-June-2009 from a consumer. A male patient of unknown age received the following vaccination on 01-June-2009: smallpox (trade name and manufacturer unknown). NOTE: Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. Eight days after vaccination, the patient reported to the ACAM2000 hotline a very large swollen, red and itchy area starting to expand from the vaccination site to outside the bandaged area. He also reported a lump radiating from the vaccination site down his arm and yellowish liquid coming from the site. Additional reactions reported were feeling "loopy" and heart palpitations. He called a doctor who prescribed an antibiotic and BENADRYL for the itching and who referred him to an infectious disease doctor. No additional information was provided. List of documents held by sender: none.
suspected vaccination failure; got shingles (left lrm and side only) STILL effected now 7 months later; This case was reported by a consumer via interactive digital media and described the occurrence of  suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 7 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The reporter stated that he/she had the shingles shot experienced shingles on left arm and side only, the patient still effected now7 months later. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
On 10/31/03 received flu vaccine; around 6 PM on 10/31/03 felt pain in left arm/hand; pt took Advil and had difficulty sleeping due to pain; no redness; arm was normal color and temperature; on 11/3 and 11/4 felt less pain; on 11/5 at gym when lifting 40 lb weight felt sharp pain, worse than on 10/31/03. Continues to have pain when lifting and moving arm; no fever.
Patient has received an expired vaccine; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA82AZ, expiry date 31st January 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.   On 3rd August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 3rd August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 3-Aug-2022 Reporter's comment: The nurse called to report that on the day of reporting, the patient had received an expired Bexsero vaccine. The expiry date was reported as January 2022 but documented as 31st January 2022 upon search. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Itchy hives around injection site, myalgias, temp elevation to 99.6 degrees F
DO NOT have completed information regarding of Flu Shot. Given new born a flu shot instead of Hep. B vaccine. Unknown outcome at this time. Delay treatment on Hep. B vaccine.
Within 2 hours all my joints had been attacked and I could no longer move.  These were the symptoms I had for 5 days with Covid prior to vaccines and I have had them every time since with every booster.  This is my 4th.  I enquired should I go ahead and it was confirmed I should. Following severe joint attacks in October 2020 when I developed Covid the following are the boosters I have had  AstraZeneca AB in February 2021 AstraZeneca AB in May 2021 SARS Cov-2 mRNA  November 2021 Pfizer/BioNTech October 2022
This case was reported by a consumer via call center representative and described the occurrence of psoriasis flare-up in a adult female patient who received Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis. Concurrent medical conditions included psoriasis. In October 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season (intramuscular). In October 2018, less than a day after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced psoriasis flare-up. On an unknown date, the outcome of the psoriasis flare-up was recovered/resolved.  It was unknown if the reporter considered the psoriasis flare-up to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were reported as follows: The patient was over 50 years old. The age at vaccination was not reported. The caller reported that she received a flu vaccine and within 24 hours her psoriasis flared. The reporter had consented to follow up.
Pt has rash all over body and raised bumps/hives. Took BENADRYL. New to area, no PCP- recommended going to urgent care, will follow up w/patient.
This spontaneous report has been received from a healthcare worker concerning unspecified number of patients of unknown age and gender. Patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with doses of improperly stored GARDASIL (strength, unit frequency and route not reported, lot # K016966 and Exp. date 10-MAY-2017). Temperature that the vaccine exposed to was 34.81 F to 34.84 F with time frame 32 hours (non-consecutive). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because of no consent to contact physician.
Two days after receiving the bivalent vaccine I started having weird sensations in both ears:  popping, feelings of fullness, etc.  I didn't think much of it until I woke up on October 16, 2022 with diminished hearing in my left ear as well as a very loud roaring noise.  Thinking I had an ear infection, I went to an urgent care who found no signs of any infection and referred me to an ENT, who I saw the next day.  The ENT documented moderate hearing loss in my left ear and mild hearing loss in my right ear.  I was eventually referred to a neuro otologist who I continue to see.  Testing with a neurologist (including MRI and MRA) as well as a rheumatologist determined there was no cause for the hearing loss and horrible tinnitus (very loud roaring in both ears).  Since onset in October, immediately following the bivalent vaccine, I have had three intratympanic steroid injections in my left ear, which has improved my hearing in that ear.  Six months later, I still have intermittent feelings of auditory fullness, passing achiness, popping in both ears.  The tinnitus comes and goes, at a lower level than what it was at the onset.
Administered the vaccine and 1-2 minutes later the patient's eyes rolled in the back of his head and he became very stiff and couldn't communicate. It lasted for about 45 seconds then the patient came back and was talking.
Myalgia chills Narrative:  reported chills and muscle aches for 48 hours following vaccine administration
Dizziness, nausea, very high heart rate, weakness, low grade fever. Missed 1.5 days of work. Treatment by rest and liquids.
Reddened, tender, slightly itchy area approximately the size of fifty cent peice; area expanded for the next 48 hours with bullseye effect to area the size of saucer.
Patient thinks that she received an expired vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient thinks that she received an expired vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient thinks that she received an expired vaccine). On 30-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Patient thinks that she received an expired vaccine) had resolved.            It was stated that Patient was expecting pain tomorrow. No concomitant medication was provided by the reporter. No treatment information was provided.
Stabbing pain in hands and back of knees, Inflammation with burning sensation in joints of finger and knuckles. Unable to walk due to severe inflammation and pain in knees and ankles. Unable to do my job properly (Dental Hygienist) due to pain and inflammation in wrists hands and fingers. Severe fatigue. Some days cannot get out of bed due to pain unless taking prednisone. Emotionally depressed. High blood pressure. Pounding heart beat in head and jaw when trying to sleep. Heart skips beat occasionally Shortness of breath when trying to go up stairs or walking and medium to long distance. Red dots on body. Areas of rash with mod itching, mostly legs. Muscle cramping and pain calf areas and thighs.
Within 2 months of second shot, patient developed rapid growth of cancer that had been in remission for 7 years.
Patient had pain at the injection site for 3 days after administration. The pain then started to change into numbness. Over the past several days the numbness has spread down his arm into his right hand and fingers. It has also spread to his shoulder, upper back, and chest/abdominal area. Patient explains numbness is localized to his right portion of the body only. It stops at the midline of his back and chest. It does not extend below his belt line.
This initial spontaneous case was received from a consumer on 18-Oct-2017, concerns 30-year-old female pregnant patient. The patient received nadolol and prenatal vitamin prior to pregnancy for an unknown indication. The patient had no medical history, maternal history relevant to pregnancy and paternal medical history included sperm donor, which used in IUI (intrauterine insemination). The patient had no previous pregnancies. The father of the fetus did not receive any medication prior to conception. The patient's concomitant medication included prenatal vitamin for an unknown indication. The patient did not use any contraceptive method. The patient's last menstrual period date was 02-Aug-2017. It was reported as first pregnancy of the patient. There was no any evidence of a defect/adverse finding from a prenatal test. The patient had given the permission to enroll in the pregnancy registry. On 13-Oct-2017, at gestation age of 11 weeks (first trimester), the pregnant patient was administered with INN Flu Vaccine Seasonal (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number, manufacturer, trade name: not reported) (explicitly coded as vaccine exposure during pregnancy). On the same day, the patient developed soreness in arm and no adverse event was reported in the fetus. No treatment was taken for the event. The same day (13-Oct-2017), patient was recovered from the event soreness in arm. The estimated date of delivery was reported as 09-May-2018. The reporter assessed the events as non-serious.
itching at injection site.; The injection site area "was hard, swollen; The injection site area "was hard, swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching at injection site.), VACCINATION SITE INDURATION (The injection site area "was hard, swollen) and VACCINATION SITE SWELLING (The injection site area "was hard, swollen) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itching at injection site.), VACCINATION SITE INDURATION (The injection site area "was hard, swollen) and VACCINATION SITE SWELLING (The injection site area "was hard, swollen). At the time of the report, VACCINATION SITE PRURITUS (itching at injection site.), VACCINATION SITE INDURATION (The injection site area "was hard, swollen) and VACCINATION SITE SWELLING (The injection site area "was hard, swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
When I went to bed for the evening, I started chilling and was shivering. I slept off and on but was uncomfortable and I would say this lasted for about 4 hours, give or take. I did not get up to take anything (Ibuprofen, Tylenol, etc.) nor did I take my Temp until the following morning and at that time it was 99.4.
Tinnitus in both ears increased. I've had tinnitus in both ears for decades but is was not a continuous hiss and a bit different in each ear. Now it is louder and is a continuous hiss in both ears.
Hives on left arm initially below injection site, but gradually growing in size up towards injection site. Zyrtec has helped. Hives still present but getting better.
Erythema and minimal induration at injection site approximately equal to 3" x 3" - warm to touch.
lightheaded; shortness of breath; is a spontaneous report from a contactable physician.   A 50-year-old male patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EM9810) via intramuscular, administered in arm left on 27Feb2021 10:58 (at the age of 50 years old) as dose 1, single for COVID-19 immunisation. Medical history included chronic hypertension (also reported as Chronic or long-standing health conditions: CHTN) and allergy to anti-malaria medications. The patient's concomitant medications were not reported. On 27Feb2021 11:15, the patient experienced lightheaded and shortness of breath. It was reported that the patient vitals were normal. The type of facility was reported as public health clinic. Patient other illness at the time of vaccination and up to month prior was reported to none. The alt symptoms resolved within IS minutes (as reported) and attributed to vasovagal response/anxiety (as reported). Unknown as reported if patient received treatment on the events. The outcome of the events was recovered on an unspecified date on 2021.   No follow-up attempts are possible. No further information is expected.
pt recv one 20 mcg dose for OSHA prophylaxis w/in 24 hr exp asthma like sx; tx w/ unspecified inhaler
Patient got out of shower and noticed rash on her abdomen.  Rash was not itchy and patient felt fine otherwise.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 28-JAN-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength 0.5 mL, lot # L027282, expiration date 21-SEP-2017, dose and route were unknown). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion five times. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the first excursion was 16, 33 and R. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the second excursion was 208, 31 and R. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the third excursion was 72, 29 and R. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the fourth excursion was 112, 30 and R. The total cumulative excursion time (hour, the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the fifth excursion was 88, 32 and R. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 06-NOV-2015 11:43, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 9.8 and 2.4 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
12/23 at 0658 vaccine was administered. 12/23 approx 12 hrs later moderate soreness of left deltoid.  12/24 moderate soreness of left deltoid, moderated itching at injection site. sit also raised warm and red approx. 4cm tall and 6cm wide. (25mg po benadryl and hydrocortisone cream applied to site) 12/25 sever soreness and itching at site. site size did not change. (25mg po benadryl and hydrocortisone cream applied to site) 12/26 moderate soreness, severe itching (hydrocortisone cream applied to site) site size did not change, less warm to touch 12/27 moderate soreness and severe itching. hydrocortisone cream applied to site, site size did not change, color mostly back to normal 12/28 mild soreness (all dissipated by evening) moderate, sporadic itching (hydrocrtisone only applied once) 12/29 no soreness mild itching no medication needed 12/30 all symptoms resolved.