chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe diarrhea; Vomiting; This is a spontaneous report from a contactable consumer (patient). This 78-year-old patient of unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 15Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the higher dose flu vaccine on an unspecified date for an unspecified indication and they got sick. The patient developed severe diarrhea and some vomiting on an unspecified date in Jan2021. The patient reported they still had diarrhea; further reporting that they read that the second dose caused more problem and consequently the reporter was considering not taking that dose. The patient reported they were sensitive to vaccine so they can only take the lower dose flu vaccine. The patient reported the one time they had the higher dose flu vaccine they got sick. The reporter's son wanted the reporter to take the second dose of the COVID vaccine but the patient fears they may land in the hospital if they do. The clinical outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
The pt experienced rash (hives) everywhere. A follow up report received 10/18/2001 adds: Pt reports he had same day response of blotchy-looking rash which was hot to touch and eventually covered most of his skin. He saw a physician who recommended Benadryl 150 mgs at HS, which he took until 10/16/01. His skin condition has almost cleared.
2 hours after shot, severe pain in right shoulder present.  Pain persistent and still present, now almost 4 months later.
No adverse event but we administered Pfizer 0.3ml to a 10 year old.
Onset of arthralgia within 5 days of vaccine, fatigue and mild anemia noted on ER visit 9/21/2022
inadvertently administered QUADRACEL instead of DAPTACEL, no AE; Initial information received on 06-Apr-2021 regarding an unsolicited valid  non-serious case from a nurse.  This case involves a 16 months old male who was inadvertently administered with 0.5 ml first dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot O5763AA and expiration date 26-Aug-2022) via intramuscular route in the right thigh for prophylactic vaccination on 06-Apr-2021 (wrong product administered) instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE (HIB) and PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL 13 VALENT VACCINE).  It was an actual medication error due to wrong vaccine administered (same day latency).   Also reported that the caller with questions on whether dose counts as valid dose of DTAP. Spoken with nurse supervisor, she had questions on if patient has already had 3 previous doses of IPV, does this extra dose of IPV pose any health risks?  It was not reported whether the patient had any adverse 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. 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.
Bell's palsy on left side; soreness at the injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number EV1685, expiry date unknown) via an unspecified route of administration on the left deltoid, left arm, on 05Jan2021 08:15 AM at a single dose for COVID-19 immunization. The patient's medical history included allergies to Penicillin and Sulfa from an unknown date and unknown if ongoing. The patient had no current Illness and no family medical history. The patient is not pregnant. Concomitant medications included metoprolol tartrate, Vitamin C [ascorbic acid], Vitamin D3, and Multivitamins; patient received these medications within two weeks prior to the COVID vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. Patient had a routine Physical Examination on Nov2020 and underwent lab tests and procedures on 24Jan2021 which included unknown BW and negative Lyme Disease Test. On 23Jan2021 18:30, the patient developed bell's palsy on left side which was reported as getting a little worse every day. The event required Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care; the event resulted in Disability or permanent damage. Since 24Jan2021, patient received Prednisone 60 mg, daily for 7days and Valtrex 1g, 3x/day (TID) for 7days as treatment for the event. The patient did not recover from the event Bell's palsy on left side.' It was further reported that patient experienced soreness at the injection site on an unspecified date with outcome of unknown.; Sender's Comments: Based on temporal association and safety profile of the product, the contributory role of the suspect product BNT162B2 to reported event Facial paralysis cannot totally be excluded.  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.
a dose of ACTHIB was reconstituted with sterile water and administered to a patient, with no AE; Initial information received on 09-Dec-2021 regarding an unsolicited valid  non-serious case received from a other health professional via Agency number: 00891537.  This case involves a 1 months old male patient who was administered  a dose of acthib was reconstituted with sterile water after receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB] (product preparation error).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE for Immunisation.  On 07-Dec-2021, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE (lot number: UJ587AA and expiry date: 17-SEP-2022) via intramuscular route in unknown administration site for prophylactic vaccination.   It was case of an actual medication error due to wrong solution used in drug reconstitution (latency: same day).  At the time of reporting, no adverse event 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 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.
Immediately after injection, pt said "ouch", then swayed from exam table edge to the floor, with dilated pupils and pallor. Received 1:1000 Epinephrine 0.4ml SC x 1. Recovered in 15 minutes.
woke up and had pain in stomach area which got worse as day went on - went to Hospital ER where I underwent several tests and was given pain medicine - was diagnosed with Acute Pancreatitis - remained in hospital from Monday until Friday (July 5, 2021 through July 9, 2021) on IV with no food or drink for three days, several tests were done, finally discharged on Friday, July 9 with instructions to see Gastroenterologist on 08/31/2021
Injection administered; 15 minute observation - normal - discharged from observation area Patient returned several hours later c/o lightheadedness, off balance, feet felt numb, throat swelling, toes tingling.  Patient placed on stretche, VS taken; upon report of throat swelling - epi-pen administered, 911 called and patient transferred to higher level of care
No signs, no symptoms, found dead at 3 AM 1/17/00. Autopsy findings (per grandmother) stated that infant died of SIDS. Grandmother interviewed by phone.
Rcvd injection at 10 am, 10:05 am rapid heartbeat, dizziness, weak. Sat down.  10:20 am heartbeat steadied, still a little disoriented but able to leave facility. 10:25am, left side of face swelled up. 10:30 am, in bed, slept for 3 hours, profuse sweating. Upon waking up, tired, swollen left side of face, headache, sore throat, injection site and other muscle pain. Back to bed 8pm, same symptoms.  Sunday morning the 18th 8 am drenched with sweat, injection site pain, swollen left  side of face. By noon, after taking daily medications and shower, cold compress on left side of face, swelling down, still feeling tired, but overall feeling better.
fever; doesn't feel well; body aches; headaches; coughing; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer, the male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. Medical history included severe allergies and susceptible to getting seasonal problems. The patient's concomitant medications were not reported. On an unspecified date, the patient did not want to do report and has a scheduled second dose of Pfizer's COVID vaccine on 27May2021. Last night the developed a fever and doesn't feel well and doesn't know if he should reschedule his appointment or not. He is feeling body aches and stated, "I cant go through another round of fever and headache. I have fever, body aches, and headaches from my coughing, but usually during the April time, I get severe allergies and I'm pretty susceptible to getting seasonal problems. I'm not sure exactly what's going on with me." Seriousness criteria was reported as non-serious. The outcome of the events was unknown.  Information about lot/batch number have been requested.
It was reported that a female pt received a TD Adult on 3/14/00. Reportedly, on 3/15/00, the pt complained of right deltoid redness, itchiness, tenderness and right extremity swelling. The pt received Keflex and Prednisone as treatment. Reportedly, the symptoms have subsided. From correspondence received on 4/10/00, additional pt, vaccine and responsible physician information was provided.
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse Event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant drug information was provided. It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine. No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow-up included I-narrative updated.
Strong metal taste in mouth within 30 seconds of shot continuing throughout day Headache starting in mid-afternoon of day 1
on 01/23/2021, after the vaccination,  it began swelling, itching, warm to touch, red around 2 in by 6 ins around the injection site.  I went to see my doctor on the 25th because it wasn't getting better and it looked like cellulitis. Virtual visit  and the doctor said it looks like cellulitis and prescribed  keflex, an antibiotic by mouth 3 x day  500 mg.   It subsided the next day after taking the antibiotics.   I saw on News they called it COVID arm, the same symptoms I had .  I received the Moderna Dose 2 (Lot #06L20L)  instead of day 7,  I had the same symptoms  on day 2 and I did not take the antibiotics and it went away  around 7 days later on its own.
Had 103 fever for 3 days and now have had tinnitus since 4/16/2021
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a female of unspecified age. 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 administration not reported, batch number: Unknown) frequency one total, dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date in APR-2021, the patient experienced suspected immunological vaccine failure. She did a blood test (nucleocapsid protein IgG antibody test) which was negative. No additional information was provided. Laboratory data included: Antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210444312;-covid-19 vaccine ad26.cov2.s -Suspected Immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
This spontaneous report was received from a healthcare worker refers to a female patient of unknown age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. The healthcare worker stated that the patient received her first dose of GARDASIL 9 on 05-AUG-2015, second dose on 07-OCT-2015 and third dose on 11-DEC-2015. The patient received her third dose too early (inappropriate schedule of drug administration). No adverse effects were not reported. Additional information has been requested.
Swelling, redness, pain to right upper arm. Subjective fevers reported. Pain described as superficial not deep - much "like a sunburn".
Initial unsolicited report received from physician on 22-Aug-2017. This case involves a female patient (age not reported) who was vaccinated with a dose of ADACEL (Batch number: U5626AA, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, 5-10 minutes following the vaccination, the patient passed out and had a seizure. It was reported that, she had a similar episode that was worked out by neurology and thought to be vasovagal. Lab data and corrective treatment were not reported. The outcome of the event were not reported. Upon internal review, the company decided to consider the event serious because of important medical event passed out and seizure. List of documents held by sender: none.; Sender's Comments: Patient passed out and experienced a seizure after vaccination. Time to onset is compatible with the role of vaccine. Seizure is listed with the vaccine. However, further information including confirmed diagnosis, patient's medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be evaluated.
a paient did not get their second dose of moderna as schedules; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (a paient did not get their second dose of moderna as schedules) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (a paient did not get their second dose of moderna as schedules). At the time of the report, PRODUCT DOSE OMISSION ISSUE (a paient did not get their second dose of moderna as schedules) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
disoriented- forgot; She was panicked; disoriented- forgot; This is a spontaneous report from a contactable consumer reported for herself.   A 77-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscularly on 24Feb2021 11:00 AM (at the age of 77-years-old) for COVID-19 immunization. The patient was not pregnant. The patient had not medical history. the patient's concomitant medications were none. The patient waited the 17 minutes when they said to wait and then she felt to be okay at that point.  About a half hour after having gotten the vaccine, person got into her car. She went to drive home and became completely disoriented, forgot her name and where she lived. She drove to her old address. Friend called her at around 12:30 to check in on her. She was panicked, she was still disoriented, did remember her name, but had difficulty with her address and thought she had a stroke.  A friend made her pull over and asked her to call 911, but she wanted to go home. She was much better when she calmed down and the and determining that a stroke likely wasn't the case. The patient did not receive any treatment. No covid prior vaccination. Her second dose was scheduled for 18Mar2021. The outcome of the events was unknown.   Information about batch number was not available and is going to be requested.
WITHIN A FEW HOURS I STARTED GETTING EXTREME HEADACHE, CHILLS WITHIN 10 HOURS AND RINGING IN EAR..  THE HEADACHE AND CHILLS WENT AWAY WITHIN A FEW DAYS; HOWEVER THE RINGING IN THE EARS HAS STAYED CONSTANT AND EVERY DAY I NOTICE A LOUD PITCH.  I NEVER HAD RINGING IN MY EARS BEFORE.
Redness around 4-5 inches across, warmth and tenderness developed around bathtime at 9:30 pm on 2/17/2016 at site where ActHib and Prevnar were administered.  Mom administered pain reliever.  Patient was fussy the next morning wanting to be held but beginning mid-day became active and began to play normally.  Redness and tenderness at site have continued since yesterday. Redness has remained the same size though less red and less warm.  Tenderness has continued.  Patient continues active, playful and has been using the leg normally but notices when she bumps the leg against something.
Patient states that her arm got really swollen and red and painful and was difficult to move for a couple of days. She states that the reaction has now gone way down and she feels better.
fainting; seizure; Tachycardia; dizziness; This is a spontaneous report from a contactable consumer. This 24-year-old non-pregnant female consumer (Patient) reported that she received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine; Solution for injection; Lot number: unknown; Expiry date: Unknown) via an unspecified route of administration in the right arm on 07Apr2021 at 12:45 PM. The patients past medical history included Postural orthostatic tachycardia syndrome. The patient was allergic to Phenergan and Zofran. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, patient had not tested for COVID-19. Concomitant medication was not reported. On 10Apr2021, at 12:00PM the patient developed Tachycardia, dizziness, fainting and seizure. The patient did not receive any treatment for the events. The outcome for the events was recovering.  Information about Lot/batch number is requested.
got really sick; got some joint problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got really sick"; ARTHROPATHY (non-serious), outcome "unknown", described as "got some joint problems". Therapeutic measures were taken as a result of arthropathy.  Additional information: During report caller mentioned that his sister got really sick off he believed either the Pfizer Covid or Moderna Covid vaccine. She got some joint problems and took steroids. Did not want to report. He would contact his sister and have her report.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.