chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse and refers to an unspecified number of patients of an unknown age and gender. No information regarding the patients' concurrent conditions, medical history and concomitant therapies was provided. On unknown dates, the patients were vaccinated with an unspecified number of doses of improperly stored PNEUMOVAX 23 lot # K008410 and expiration date: 26-FEB-2016, lot # L014420 and expiration date: 23-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. Additional information has been requested.
2 and 1/2 days after the vaccine he broke out in blisters on right wrist.
12 hours after the injection, pain in the whole left arm, 8 on vas scale. Did not sleep that night. 02-10-21; low grade fever 100.F., started with pressure in chest and back. I had a bad headache also. By 11am that day, the fever started climbing up to 102.5. F. The chest pain and pressure were getting worse. I accidentally laid down on my stomach and the pain got tolerable. 02-11-21; fever was still 101.5F, also had chest and back pain, not quite as severe day I called my doctor they said it was a costochondritis. My doctor told me told me to take Ibuprofen and by Friday I was down to 99.6.F with mild chest discomfort and arm soreness and by Saturday I was symptom free and fever free.
temp 102, fatigue, cough all were sudden onset;MD visit 2 days later put on amntadine;7APR97 PC mom who reports pt was dx w/influenza type B by lab testing;
Unable to move arm in certain directions. Saw Urgent Care. Saw Orthopedics Dr. received steroid shot. Orthopedics Dr. - surgery on 10/20/2016.
This spontaneous report was received from a pharmacist referring to a 76-year-old male patient. The patient had not any medical history, concurrent conditions or concomitant medications. The patient was vaccinated on  an unknown date in September 2017 with PREVNAR 13 and on anunspecified date in September 2018 with influenza virus vaccine inactivated (unspecified). On 28-NOV-2018, the patient was vaccinated with PNEUMOVAX 23 lot # R016638, expiration date 28-JAN-2020, (dosage schedule, route and anatomical location were not reported). On approximately the same day, (reported as "not sure if on 28-NOV-2018 or 29-NOV-2018), the patient experienced sharp pain in the arm, at injection site, as well as,  decreased limb mobility, skin warm and malaise. The reporter stated that the patient did not sought medical attention and received treatment for the events but at the time of reporting the patient was not recovered. Laboratory diagnostics or studies were not performed. The causality assessment between the adverse events and the suspect vaccine was not provided at the time of this report.
Painless swelling of left arm 3x4cm. No secondary infection.Increased heat & warmth in area of site. Treated with cool compresses & benadryl
Got vaccines at approximately 9 am on day of event, then about 15 minutes after went down to lab for a blood draw. At the thought of getting blood drawn, patient fainted then hit his head. After hitting head had brief episode of tonic clinic movements, eyes rolling back of head. No known post ictal period. Episode witnessed by lab staff, lasted approx 1 min. Sent to ED for further eval, had neg CT, subsequently asymptomatic without further events. No prior known vax reactions.  Most likely vasovagal event and brief seizure like episode related to fall. Unclear if related at all to vaccines.
I had local injection site soreness - resolved after a day or two. I just noticed I had muscle aches - seemed local to both thighs. I told my OB in a regular prescheduled checkup. It bothered me more than my belly did. Ached when I walked and when I got up and out of a chair - had to grab on to the chair or when I went up or down the the steps - had to hold the rail. I was close to full term. It resolved about the week after and I delivered shortly after that, too. I didn't miss work because of the adverse symptoms as it was my last day of work anyway.  Estimated due date: February 7, 2021; delivered January 31st; Birth weight - 7 lbs 5 oz. 1st pregnancy - vaginal delivery. No complications during pregnancy. After delivery I had high  blood pressure which was new. I think it's getting better - I'm trying to wean off the high blood pressure medication at this time.
1 1/2 day p/vax pt devel myalgias, arthralgias, fever to 104.1 sinus pressure;
Period was 15 days late with no possibility of pregnancy and lasted twice the normal length. The next period came two weeks early and lasted twice the length typical. Multiple instances of spotting during menstrual cycles since second vaccination which has never happened before.
Vaccination site scar; Arm discomfort; Vaccination site rash; Vaccination site pain; Swollen arm; Vaccination site joint redness; Bite; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE JOINT ERYTHEMA (Vaccination site joint redness), BITE (Bite), VACCINATION SITE SCAR (Vaccination site scar ) and LIMB DISCOMFORT (Arm discomfort) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 04-Apr-2020. Concomitant products included VITAMIN D NOS for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE JOINT ERYTHEMA (Vaccination site joint redness), BITE (Bite), LIMB DISCOMFORT (Arm discomfort), VACCINATION SITE RASH (Vaccination site rash ) and VACCINATION SITE PAIN (Vaccination site pain ). On 14-Feb-2021, the patient experienced VACCINATION SITE SCAR (Vaccination site scar ). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 14-Feb-2021, PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE JOINT ERYTHEMA (Vaccination site joint redness), BITE (Bite), VACCINATION SITE SCAR (Vaccination site scar ), LIMB DISCOMFORT (Arm discomfort), VACCINATION SITE RASH (Vaccination site rash ) and VACCINATION SITE PAIN (Vaccination site pain ) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was scheduled to receive her second dose of the vaccine on 11Mar2021, but she was told by her doctor that she may not need the second dose, as she may have acquired the antibodies. He also suggested if she does had  the second dose, that she take Tylenol and Benadryl the day of the second dose to avoid swelling. The patient wished to know if she could avoid the second dose and if she did have the second dose, could she take Benadryl and Tylenol. The patient provided no further information but provided consent to be contacted by Safety.
vaccine was administered outside of storage recommendations. patient returned on 6/5/21 to re-vaccinate
Pfizer-BioNTech COVID- 19 Vaccine EUA Approx 5 minute post vaccination, patient began reporting itching.  Shortly after, developed a dry cough and reported that her throat "felt funny." Patient began vomiting and having difficulty breathing, speaking in 1-2 word sentences.  Pt received epi pen to left thigh, with some resolution of symptoms.  Pt continued to have cough and nausea, chest pain. Gave 25 mg benadryl IM at 08:27 am.  Patient received 2nd dose of Epi for increased SOB, difficulty breathing, and increasing cough, with some resolution of symptoms.  Patient reported increased chest pressure.  Began having seizure like activity at 08:30, lasting approx 20 seconds with no post ictal period noted. EMS arrived after 2nd dose of epi.  Second "seizure like" activity after EMS arrival, lasting approx 20 seconds.  During transport to ambulance, patient had 2 more episodes of seizure like activity with no post ictal phase.  ED note states low suspicion for true seizure since patient was awake during episodes of tonic clonic movements, answering questions during, and did not have post ictal state.
Post vax, the pt was rejected when giving blood due to the presence of an unspecified antigen. No further information is available.
Hives tracking from injection site to left scapula, associated itching within 2 hours from injection; following morning faint rash extended to right scapula. Gave PO and topical BENADRYL and CLARITIN, itching resolved promptly, hives were fading within 1-2 hours. No rash elsewhere, injection site itself looked ok. No oral/facial involvement. She otherwise felt fine.
Fatigue, weakness, shaky, short of breath, tired. nauseated, palpitations, headaches, feels like she is 'hung-over' all of The time (headaches). muscle aches . all over The body.  chest pressure all symptoms starting within  2 weeks of the 1st vaccine. and worsening with the 2nd vaccine
This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received ENGERIX B adult (batch number Unknown, expiry date unknown). On an unknown date, the patient received the 2nd dose of ENGERIX B adult. On an unknown date, an unknown time after receiving ENGERIX B adult, 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: Dose 2 of the 0, 1 and 6 month schedule was approx 1 month late. Lot and expiration unknown.
pharmacist had accidental exposure to pneumococcal vax after the vaccine came into contact w/skin, pt exp itching, nausea, dizziness & devel hyperactivity;
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Aug2023 as dose 4 (booster), single (Lot number: GK0928) at the age of 37 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL3247), in left arm, on 11Feb2021 as dose 2, single (Lot number: EN6201), in right arm and on 30Sep2021 as dose 3 (booster), single (Lot number: 30155BA), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Shellfish allergy". The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 and included treatment with Paxlovid from 06Sep2023 to 10Sep2023.
broke out in a terribly painful shingles rash on her upper left chest; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in left arm on 02Mar2021 10:00 (Batch/Lot number was not reported) (at age 65 years old) as single dose for covid-19 immunisation. The patient is not pregnant at the time of vaccination. Medical history included no thyroid, heart condition, total knee replacement, DJD, shingles, and known allergies (unspecified) all from an unknown date. No covid prior to vaccination and was not covid tested post vaccination. Concomitant medications included levothyroxine and liothyronine, both taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 on 09Feb2021 08:00 (lot no: EL9269) in left arm for COVID-19 immunization. No other vaccine in four weeks. On day 2 following her second vaccine, on 04Mar2021, the patient broke out in a terribly painful shingles rash on her upper left chest. She has had shingles before and been vaccinated fully for shingles. It is now day 3 and rash is still painfully present. Treatment not given for the event. The patient had not recovered from the event.   Information about lot/batch number has been requested.
Injection site was red; Injection site was firm; Injection site / hot to the touch; This case was reported by a consumer via patient support programs and described the occurrence of injection site erythema in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) for prophylaxis.   On 12th October 2020, the patient received Fluarix Quadrivalent 2020-2021 season (intramuscular). On 13th October 2020, 1 days after receiving Fluarix Quadrivalent 2020-2021 season, the patient experienced injection site erythema, injection site induration and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site induration and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site induration and injection site warmth to be related to Fluarix Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Fluarix 2020-2021 vaccine via the intramuscular route in the left arm.  It was performed by the pharmacist.  The injection site was swiped once with an alcohol wipe 5 seconds before the injection.  The patient experienced injection site was red, firm and hot to the touch in an area about the size of a deck of cards.  That symptom persists, with the addition of a track mark going up and down the arm.
Case number PHEH2014US021997 is an initial spontaneous report received from a pharmacist on 29 Oct 2014. This report refers to a female patient of an unspecified age. Her medical history and concomitant medications were not reported. On an unspecified date, 20 years prior to this report, the patient was vaccinated with FLUVIRIN (batch number: not reported) and developed a rash around the site of administration of FLUVIRIN. The patient thought it was due to a thimerosal allergy. The outcome of the event was not reported. The seriousness and causality of the event were not reported.
No adverse event; patient received the bivalent dose of Moderna COVID19 vaccine as a first dose in another facility; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received the bivalent dose of Moderna COVID19 vaccine as a first dose in another facility) and NO ADVERSE EVENT (No adverse event) in an 18-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013h22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Nov-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Nov-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (patient received the bivalent dose of Moderna COVID19 vaccine as a first dose in another facility). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received the bivalent dose of Moderna COVID19 vaccine as a first dose in another facility) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (patient received the bivalent dose of Moderna COVID19 vaccine as a first dose in another facility).    No concomitant medication was provided by reporter.  it was reported HCP wanted to know what to do next Patient wanted to receive the second dose of the primary series and looking at the patient's records HCP realized that the patient received the bivalent dose of Moderna COVID19 vaccine as a first dose in another facility, date of administration Nov15 2022.  No treatment medication was provided by reporter.
PT RECEIVED FIRST INJECTION AT WELL CHILD VISIT 10-7-2019 . SEEN IN URGENT CARE 10-12-2019 WITH SYMPTOMS OF RED, ITCHY RASH ON ABDOMEN, LEGS AND ARMS . SYMPTOMS GRADUALLY PRESENTED ON 10-8-2019 PER MOM. NO TREATMENT WAS GIVEN AT HOME PRIOR TO URGENT CARE VISIT.  URGENT CARE PHYSICIAN ASSISTANT NOTED ON SKIN EXAM: red round well demarcated lesion noted on the arms and legs as well as the abdomen ,buttocks, back and chest excoriations are noted it is Not hot or oozing no signs of infection are noted.  ASSESSMENT/PLAN:  Acute dermatitis - all over chest, back arms and legs L30.9: Dermatitis, unspecified triamcinolone acetonide 0.1 % topical cream - apply to affected to affected area twice daily for rash     Medrol (Pak) 4 mg tablets in a dose pack - Take 1 dose pk(s) by oral route.       Benadryl Allergy 25 mg tablet - Take 1 tab every 4-6 hours prn     Solu-Medrol (PF) 125 mg/2 mL solution for injection - Take 125 mg by injection route.     Quantity: 125 mg GIVEN AT TIME OF URGENT CARE VISIT 10-12-19
pt recvd vax 25MAR93 & 27MAR93 devel itching & welts on thighs, arms, chest & neck; No further details were provided;
Fever 106.6 and treated in ED. Fever down to 101.1 after Advil.
3 hours after injection, experienced pain and tenderness at injection site; facial flushing that persisted for 3 days; This is a spontaneous report from a contactable 75-year-old non-pregnant female nurse (patient) reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 05Feb2021 at 09:15 am at single dose for covid-19 immunization on left arm. The patient's medical history included hypothyroidism, breast cancer and known allergies: Shrimp, cilantro, contrast dye, gadolinium. Concomitant drugs included Levothyroxine sodium, ciclosporin (RESTASIS), multiple vitamins. On 05Feb2021, 3 hours after injection (12:00 PM), the patient experienced pain and tenderness at injection site, facial flushing that persisted for 3 days. Benadryl 25mg taken every 4 hours for 2 days for flushing. The laboratory test included temperature taken and WNL (within normal limits) 97.2 during flushing period. The outcome of the events was recovered.   Information about Lot/Batch number is requested.
I had some stomach issues and head cold like symptoms. I had diarrhea and the next day I began to have a sore throat and was feeling unwell. I started having a fever of around 101 on that Wednesday. After about 3 days it started coming down. I also had started coughing. The doctor did not prescribe any medications, just over the counter TYLENOL was taken. I started to feel better around January 2nd, 2023. Most of my symptoms were gone by the 3rd or 4th of January. I took about a month to feel my energy was back.
This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash was itching) and RASH (rash is on both arms and inside elbow and on back,rash on legs look like a mosquito bite on each leg) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced RASH PRURITIC (rash was itching) and RASH (rash is on both arms and inside elbow and on back,rash on legs look like a mosquito bite on each leg). At the time of the report, RASH PRURITIC (rash was itching) and RASH (rash is on both arms and inside elbow and on back,rash on legs look like a mosquito bite on each leg) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment details included One dose of diphenhydramine last night.
Child began clawing at his face and mouth on the 10th.  Eye tics set in later that week - tics so bad he was unable to walk through them.  Rushed to ER for suspected seizures.  Has been to multiple specialists and systems have continued to get worse including:  tics, slurred speech, difficulty walking, extreme fatigue, constant screaming and screeching, complaints of headaches, arm swinging, head banging, repetitive behaviors, aggressive behavior.  Before this date he was a normal, happy, healthy, well adjusted toddler.
Mar90 pt vax w/ 1st hepta B w/o adverse effect. Apr90 vax w/ 2nd hepta B. Jun90 pt devel muscle weakness which began in arms and went to legs and stomach muscles.  pt to hosp and dx w/ Guillain Barre Syndrome.
Caller has had 6 Pfizer Covid ...his doctor told him to take Paxlovid anyway; Caller has had 6 Pfizer Covid ...his doctor told him to take Paxlovid anyway; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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 5 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 1, SINGLE), administration date: Aug2020, for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller has had 6 Pfizer Covid ...his doctor told him to take Paxlovid anyway". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Caller stated that had 6 Pfizer Covid 19 since Aug2020.  He wants to "thank your company for actually keeping me healthy." He states that without his vaccines "my infection earlier this week might have been a nasty activity." He states he had a mild cough and that was it. Not even a fever. He successfully completed the 5 day program and he feels great. "I just feel wonderful today."  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
My tongue has a funny taste. Kind of like putting a 9 volt battery on your tongue taste.
local reaction to lt arm, swelling, itching, red & hot (over 3 day period);
1. First shot, no adverse effect. 2. After the second shot I developed chills, aches and a very slight fever within four to five hours of the shot. Later that night I noticed a decided lack of energy and some arm soreness at the shot site when I touched it. The chills and fever subsided after about two to three hours, but the rest of the symptoms continued until I fell asleep around midnight, which was about 12 hours after getting the shot. The aches, arm soreness and weakness all lasted for about a week afterwards, with the weakness being the last thing to go.
Pt had a vasovagal episode at 10:20 right after vaccine administered, laid down pt, elevated leg vitals taken120/80 72 98% 99.5, then 5 minutes later took another vital 118/78 73 16 97% 98.7,  gave water sips, pt recovered with no difficulties. ER precaution given, observed for another 15 minutes and pt left with mother.