chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine was administered 1ml instead of 0.5ml; A spontaneous report was received from a pharmacist concerning a 77-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and 1ml of dose instead of 0.5ml.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 01 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 014M20A) in right arm for prophylaxis of COVID-19 infection.   On 01 Mar 2021, pharmacist administered 1ml instead of 0.5ml of the vaccine to the patient (Accidental overdose).  No treatment information was provided.  Action taken with mRNA-1273 in response to the event administered 1ml instead of 0.5ml of the vaccine to the patient is not applicable.  The outcome of the event administered 1ml instead of 0.5ml of the vaccine to the patient, was considered recovered.; Reporter's Comments: This report refers to a case of Accidental overdose for mRNA-1273, lot # 014M20A with no associated AEs.; Sender's Comments: MOD-2021-034019:Crosslink case. MOD-2021-034220:Crosslinked case.
Dizziness, chest tightness, heart flutters difficulty swallowing difficulty breathing coughing up phlegm dizziness occurred moments after the shot all other symptoms started after the shot and are continuing three days later
pt recv vax & by late evening pt having strong & frequent sz & T103;pt was given med;
1/29-Reported increased fatigue, weak and itchy, hands were red and blotchy. MD updated and PRN Benadryl given with good effect. C/O nausea and decreased appetite 1/30 received PRN Zofran with good effect. No further complaints 2/1
dose of acthib was given past the expiration date with no adverse event; Initial information was received on 01-Feb-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional.  This case involves 15 months old female patient who stated dose of acthib was given past the expiration date with no adverse event after receiving haemophilus type B (HIB) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13); and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (Daptacel).  On 27-Jan-2023, the patient received 0.5 ml dose of suspect haemophilus type B (HIB) vaccine Powder and solvent for solution for injection (lot UJ584AAA, expiration date: 16-Oct-2022) (strength, frequency was unknown) via intramuscular route on left thigh for Immunization.  On 27-Jan-2023 the patient developed a non-serious event dose of acthib was given past the expiration date with no adverse event (expired product administered) same day following the administration of hib (prp/t) vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient reports that 2-3 days after vaccination he developed a 2" diameter red circle with some swelling and dry skin. Patient states Dial soap and cold shower water helped to provided relief.  Patients reports a few headaches too.  Patient states he will see his PCP.
magnetic area where the shot is administered/magnet sticks; This is a spontaneous report received from a contactable consumer (patient).  A male patient of an unknown age received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date were not reported) via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient asked about the COVID vaccine, asked whether the patient could be put to ease about the magnetic area where the shot is administered which led to vaccination site reaction. She stated that she had done it to herself, friends, family, as well as complete strangers and the magnet sticks just to the area where they were injected. She would like to get the vaccine however any information on this matter is unavailable. Therefore, there is no information regarding events of magnetic effects at the site of injection. The clinical outcome of the event was reported as unknown.  As of 30Apr2021, safety surveillance database for Pfizer-BioNTech COVID-19 vaccine revealed no spontaneous reports of magnetic properties at injection site since the market introduction (including emergency use authorization) of Pfizer-BioNTech COVID-19 vaccine. Also, a search of the published medical literature on 19May2021 failed to identify relevant information on this topic. Therefore, we are not aware of any information regarding events of magnetic effects at the site of injection.   Follow-up attempts are possible. Further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Nov2021 at 11:30 as dose 3 (booster), single (Lot number: feb527) at the age of 51 years, in left arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Sleep apnoea syndrome" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). There were no concomitant medications and reported as no other medication in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative, notes: symptoms returned after completing Paxlovid course and testing negative; (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid (start date: 02May2022, stop date: 06May2022). Clinical course was reported as, on 14May2022 the patient had symptoms returned after completing Paxlovid course and testing negative. No therapeutic measures were taken as result of symptoms and on 20May2022 patient was recovered with lasting effects.  No follow-up attempts are possible. No further information is expected.
Became ill several days after 2nd injection. Weak tired no energy. On the 18th of March a slight ringing in my ears developed. It became severe and I went to the doctor on April 1st. The week and tired feeling had left but the ear ringing stayed constant. The ENT said I have developed Tinnutius.
Patient suffered brief LOC within minutes of receiving the flu vaccine, lasting approx 30 seconds. Patient was diaphoretic and pale with eyes rolled back. 10:40 BP 98/60. Placed in prone position with legs elevated and ice pack to back of neck. Mom was present. 10:56 BP 110/80 L arm. Patient stated hadn't eaten today, she was seated up and given water and snack. Color improved and she left with mom at 11:15am.
The night I received the vaccine I woke up at 3am and was chattering my teeth like I had the chills.  I then went into a whole body like shake/jerk for I would say 5 seconds. It felt controllable yet uncontrollable at the same time.  Approximately 2 weeks later or so I noticed muscle twitching.  It may have been happening closer to vaccination date however I didnt notice until 2 weeks later.  My right eye lid twitch is consistent and has not gone away.  I have had other spots that would twitch a lot for a few days and then subside.  As of this date 12/10/21 I am still twitching it is mostly in my legs and appears to be more frequent or noticeable in my right leg.  It still happens throughout my whole body and is noticeable at rest.  Within the last 2 days I have begun to get muscle cramps in my calves, forearms, bottom of feet, and trapezoids - the cramping comes and goes and is minor and feels like a tugging stretching like sensation.    I am concerned enough now that I have reached out to medical professionals for help.  I will be getting a blood test soon and I saw a Neuro who said he has seen a lot of people who have been vaccinated that are twitching and he thinks its Benign Fasiculation Syndrome.
Patient followed up in clinic on 12/18/2017. Had rash at injection site along with pruritus on left upper arm and skin lesion. Was given fluocinonide cream and hydroxyzine along with ice therapy.
red, spotchy rash on back for 7 days. Rash has not resolved, but has significantly improved.
In the afternoon and evening of immunization, extreme fussiness, fever of 100 (on Advil), inconsolable crying for 2+ hours, vomiting the next day and taken to ER.
Cellulitis; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CELLULITIS (Cellulitis) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cancer. Concurrent medical conditions included Diabetes mellitus, Mental handicap NOS and Reaction to previous exposure to any vaccine (Had a bad reaction to tetanus shot.).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant). At the time of the report, CELLULITIS (Cellulitis) had resolved.            No relevant concomitant medications were reported. Patient had symptoms of injection site warmth, redness, lump and pain. As per the reporter, the reaction was caused by a scratch not the vaccine, as it hadn't exactly taken place at the injection site.  Treatment information included Ibuprofen, hydrocortisone cream, cold compress and antibiotics. Action taken with mRNA-1273 in response to the events were not applicable.  Company Comment: Based on the reporter's causality (reaction was caused by a scratch not the vaccine) the event is assessed as not related to mRNA-1273.   Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: The diagnosis of the reported events and new treatment were reported.; Sender's Comments: Based on the reporter's causality (reaction was caused by a scratch not the vaccine) the event is assessed as not related to mRNA-1273.
Day 8/8/19 Administration Boostrix RA Menactra LT Day 8/14/29 Impetigo rash near site and extend to all arm right Day 8/19/19 Rash all over the body - ID consult Dr 8/23/19 on steroids - phone call improved 8/27/19 Developed diarrhea - allergy + dermatology consult 9/9/19 Dermatology pA - pustular folliculitis - dermal lymphoid  infiltrate with eosinophil and scattered dyskeratotic keratinocytes  10/7/19 Cardiology irregular heart date dr - NL holter 10/19/19 Developed ticks in the mouth - repetitive movement of arms  11/7/2019 Doing well normal exam
24 hours after vaccination - moderate muscular and joint pain, mild headache, mild arm pain at injection site 48 hours after vaccination - moderate joint and muscular pain, mild headache, mild fatigue 72 hours after vaccination - mild joint and muscular pain, moderate fatigue, diarrhea, nausea, mild ear pressure (worst overall day after vaccination) 88 hours after vaccination - feeling much better as symptoms listed above have dissipated
This spontaneous report has been received from a medical assistant refers to a 18 year old patient. On 24-JUL-2014 at 10:00 AM the patient was vaccinated with the first dose of GARDASIL (dose and route not reported, lot # J013324, expired date: 12-FEB-2016) in the right deltoid that was improperly stored. There was no illness at time of vaccination or pre-existing allergies, birth defects, medical conditions. There was no adverse event following prior vaccination. Medical assistant confirmed that GARDASIL was administered according to the dose and route recommended in the prescribing information. N adverse effects were reported. No product quality complaint (PQC) was reported. This is one of several reports from the same source. Additional information is not expected.
Information has been received from a registered nurse referring to unspecified multiple patients of unknown age and gender. The patients' concurrent conditions, pertinent medical history and drug reaction/allergies were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M011840, expiration date 01-FEB-2018; dose and route were unknown). The vaccines were stored at 48.7 Fahrenheit degree for 65 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Extreme Swollen lymph nodes under both armpits; today, I still have swollen lymph nodes and very sensitive breasts/nipples.  I just went to my OBGYN yesterday, and there are no lumps, but she confirmed swollen lymph nodes after 2 months.  I will be getting a bi-lateral ultrasound on Friday.
Started with clammy hands, pain between the shoulder blades. Then she had slight flushing and chest pressure. We had her lay down with cold cloth on her neck and within 20 minutes it all passed but then she had a wicked headache. When she went home last night, she broke out in a rash on torso and arms
A physician reported the occurrence of mononucleosis-like symptoms in a male of unspecified age who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. The pt's medical history, concurrent conditions and concurrent medications were not reported. On an unspecified date, the pt received his 1st injection of Engerix-B. At an unspecified time post-immunization, the pt experienced mononucleosis-like symptoms. The outcome of these symptoms was not specified. On an unspecified date, the pt received his 2nd injection of Engerix-B. He again experienced mononucleosis-like symptoms, including splenomegaly. The splenomegaly resolved after 2 to 3 months. The outcome of the other mononucleosis-like symptoms was not reported. Comment: The physician indicated that a 2nd subject experienced mononucleosis-like symptoms following receipt of the 1st injection of Engerix-B. However, the pt is not presently identifiable.
Hematuria lasting approximately 36-48 hours, with mild lower back pain and muscle fatigue.  Emergency room care of IV fluids.
Cellulitis (red swollen hot to touch itching upper left arm). Right arm did not have any issues.
Patient received a dose of Janssen after completing a series of Moderna. 1st dose of Moderna on 2/6/21, 2nd dose of Moderna on 3/6/21, and 1st and only dose of Janssen on 5/21/21.
THE PATIENT RECIEVED A JANSSEN VACCINE THAT WAS PAST THE 6 HOURS BEYOND USE TIME ONCE PUNCTURED; THE VACCINE WAS ADMINISTERD 7 HOURS AND 10 MIN AFTER PUNCTURED BUT THE PATIENT HASNT HAD ANY ADVERSE REACTIONS AT THIS TIME RELATED TO THE ACCIDENTAL VACCINATION
Pt sent to ER by Wellness Center due to pt having h/o reaction to reg flu shot; pt rec'd Covid injection, approx 30min later began having dry cough/throat swelling/tightness in chest, couldn't breath; ER nurse adm epi pen to L arm; provider came into room and additional meds were adm; D/C home at approx 1630 in private vehicle w/Spouse. pt was still drowsy; woke 10AM next day still drowsy w/some chest tightness; sharp pain; couldn't move around/walk due to weakness the following day ret to clinic for flu injection and was denied; stayed home until 12/14/21-ret to clinic and c/o being still tired/generalized soreness
itching at the injection site; This case was reported by a nurse via sales rep and described the occurrence of injection site itching in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo .5 ml. On an unknown date, unknown after receiving Menveo, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was unknown.   It was unknown if the reporter considered the injection site itching to be related to Menveo.  Additional details were provided as follows: The age at vaccination was not reported. The patient was teenager. The patient received Menveo and experienced injection site itching. This case has been linked with US2021AMR020769 and US2020AMR239598, reported by same reporter.
Severe depressive episode that lasted two days, and then repeated 7 days later for one day.
This patient had a temp of 101, 12 hours after injection of Prevnar at 2 years old.
This spontaneous report was received from a registered nurse refers to an unknown number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were inadvertently vaccinated with improperly stored MMR II, (strength, dose, frequency, and route of administration not reported). No adverse effects reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
After receiving my second Moderna vaccine on 2/23/21, I began urethral bleeding on March 2, 2021.  I made an appointment with Dr. and he gave me an exam within one week of the bleeding.  Dr. said I had a urethral caruncle and was bleeding from the urethra.  Dr. prescribed vaginal estrogen cream be used for 6 months.  The bleeding continued for another two weeks.
Within two hours arm was sore and warm. Painful enough after 10 hours sleep was disturbed. After 17 hours was awakened (3 AM) in a profuse sweat with chills, nausea but no vomit. Symptoms were acute for 2 hours. Resolved significantly by 7 AM. No treatment or OTC taken.
24 hours within of receiving vaccine, developed left arm pain with swelling. Parent reported redness and swelling immediately after vaccine injection - sx continued past 24-48 hours. Enlarged tonsils on exam; rapid Strep test negative. Started KEFLEX for DX: Cellulitis. Returned to ER same day for continued swelling. Improved with BENADRYL.
Flu like symptoms.; Feel sick; Throwing up; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 21Apr2021 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. On 22Apr2021, approximately 6-8 hours later, the patient started to feel sick, throwing up and flu like symptoms. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events patient started to feel sick, throwing up and flu like symptoms were resolving at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a healthcare professional regarding a patient of unknown age and gender. The patient's medical history or concurrent conditions were not provided. On 14-AUG-2015, the patient was vaccinated with the first dose of VAQTA (dose, route, lot number and expiration date were not provided). On 10-OCT-2015, the patient was vaccinated with the second dose of VAQTA (dose, route, lot number and expiration date were not provided), earlier than the recommended minimum interval as per prescribing information. There was no adverse effects reported. Additional information has been requested.
Loss of bladder control and extreme shivers.....over in 24 hours.  Left eye very uncomfortable for 3-4 weeks.  Felt as if something was in my eye (behind) Sight not effected but am hesitant to receive 2nd dosage.
Immediately after the vaccination, the pt went limp and fell to the floor. There was no seizure-like activity, no loss of consciousness, no prior history of reaction to immunization, no egg allergy and no prior history of seizures. Few wheals were noted on left side of face. Epinephine was immediately given with prompt response. Pt transported to the hospital ER for further evaluation.
Pt states she noticed red itchy bumps on fingers around 4:00pm. She assumed it was nothing big maybe a splinter. She says she then noticed it was spreading to her toes. Pt states she feels tingling and "weird" sensation also noted to soles of feet.
The night of injection her left arm hurt. It has hurt constantly since that day. Pt says she tries not to move her arm because it hurts. She states she cannot lie directly on the arm since it hurts.
Pregnant. About 5 weeks after vaccine, she came down with nasal congestion, fever and sore throat. Two days after symptoms started she tested positive for Covid.
The patient was to get the second dose Pfizer covid vaccine.  Instead patient received Pfizer covid booster vaccine.
Pt developed pain at the injection site the morning after receiving the vaccine (about 24 hours later). 5 days later pt has two bruises on injection arm below injection spot and still complains of pain
area where vaccine was administered stareted to itch; VERY RED; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (area where vaccine was administered stareted to itch) and VACCINATION SITE ERYTHEMA (VERY RED) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Mastectomy (Mastectomy and Lymph nodes removal (Left.). Concurrent medical conditions included Drug allergy (Allergic to Sulfas, Penicillin, codeine, Iodine, Tetracycline) and Allergy (Dust and Sprouts).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (area where vaccine was administered stareted to itch) and VACCINATION SITE ERYTHEMA (VERY RED). The patient was treated with DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) (oral) at an unspecified dose and frequency and CAMPHOR, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC OXIDE (BENADRYL SKIN ALLERGY RELIEF) (topical) at an unspecified dose and frequency. On 22-Jan-2021, VACCINATION SITE PRURITUS (area where vaccine was administered stareted to itch) had resolved and VACCINATION SITE ERYTHEMA (VERY RED) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.. The treatment Benadryl Skin Allergy was applied topically via spay.