chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was supposed to receive the 6mo-4yr covid vaccine due to being 9 months of age. Patient received the 5-11yr covid vaccine in error. Provider was notified.
Do to an oversight, Patient received Hep B immunization to (R) Thigh approximately 2 weeks after first Hep B immunization. No adverse signs/symptoms. Physician notified along with patient's family.
Pt. came to Health Dept. on 8-4-09 with mom to get vaccinations. Pt and mom returned to Health Dept. on 10-8-09 for proof of pregnancy. According to time of last menstrual period, she would have been about 3 weeks pregnant, but unaware at time of vaccine admin.
Patient fainted and hyporesponsive.; Patient fainted and hyporesponsive.; This is a spontaneous report from a non-contactable other healthcare professional.  A 21-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot number: En9265, intramuscular on 13Feb2021 at 14:00 (at the age of 21 years old) as a single dose in the right arm for COVID-19 vaccination. The patient's medical history and concomitant medications were 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 vaccination. The patient fainted and was hyporesponsive on 13Feb2021. The patient did not receive treatment for the events. The outcome of the events was recovered in Feb2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on vaccine-event chronological association, a causal relationship between events fainted and was hyporesponsive and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), cannot 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.
received 0.5ml dose instead of 0.25ml booster dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (received 0.5ml dose instead of 0.25ml booster dose) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012h21b) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (received 0.5ml dose instead of 0.25ml booster dose). On 19-Nov-2021, ACCIDENTAL OVERDOSE (received 0.5ml dose instead of 0.25ml booster dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
I felt swelling of tongue and slight nasal congestion. Was given benadryl and observation period was extended to 30minutes. No vital sign irregularities  or worsening of condition.
Hives developed within 8 hours of administration. He was treated with BENADRYL.
Positive COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced COVID-19 (Positive COVID-19). At the time of the report, COVID-19 (Positive COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Within 2 days, I felt feverish, chills, constipation, then diarrhea, every bone in my body hurt, mucus, after 2 days of this, went to bed and stayed there except for trips to bathroom and to get meds.  Doubled up on Aleve, took Tylenol, used vicks, have a humidifier and cool mist vaporizor.
Moderate to severe soreness, muscle pain at injection site. The pain got worse around 12 hours after the injection.
pt seen in ER 3/13/99 w/severe pain, redness & swelling to LA, treated w/dicloxacillin for infect to site & adverse rxn. Symptoms resolved after medication.
Nurse administered Dtap and PENTACEL (DTAP/HIB/IPV) in left thigh of infant without realizing the double Dtap dose until documenting in computer after vaccinating child. Vaccine given approximately 10:40 AM on 11/20/18. No signs/symptoms noted at time of visit. Follow up call on 11/21/18 at 0845 with mom (via translator). No signs/symptoms noted. Mom thought increased temperature but confirmed temperature 97 F while on phone. Mom made aware of error. Mom reassured since no symptoms at this time, but mom is to monitor for fever, redness or swollen injection sites, fussiness. Mom to call Health department if symptoms arise to coordinate follow up care.
She could not lift or rotate her arm/person to complain about this; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (002191). This is 4 of 5 reports.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "She could not lift or rotate her arm/person to complain about this".  Additional information: This spontaneous report from a contactable consumer reporting same events under the same suspect product for 5 patients. No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. Below is the verbatim report. Reporter wanted to know if she has the correct information about getting a refund for her husband who is taking Latanaprost. The eye drops never worked, no solution came out of the bottle, relayed information from withheld and she did have the correct info. As we were talking she said when she got her 1st dose of the Pfizer Covax vaccine she could not lift or rotate her arm. It still has not gone away. When she went to get her 2nd dose the HCP told her she was the 5th person to complain about this. He told her the first dose was given in the wrong part of her arm. She is now waiting to have surgery on her arm. She said she is an RN and this has affected her job as well. Caller did not want to go to (name) so will fax on her behalf.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101619553
febrile convulsions, Pt had T, & vomited approx 2 hrs later, Tongue became swollen & stopped breathing & turned blue, Taken to ER
mom reported extreme pain i child lt leg immed p/vax & for 24hr cried when ever that leg was touched;
DIED DAYS AFTER THE SHOT; This spontaneous report received from a consumer via a company representative concerned a 35 year old male with unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was healthy and an Olympian. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported,1 total, start therapy date was not reported 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, the patient died days after the shot and the patient died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211048841-Covid-19 vaccine ad26.cov2.s-Died days after the shot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Debilitating migraines; This is a spontaneous report from a contactable other HCP.   A 44-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 07Feb2021 12:00 (Batch/Lot Number: EN5318) as single dose at the age of 43-year-old for COVID-19 immunisation, administered at a facility.  The patient medical history was none. No known allergies. The concomitant medications were not reported. The patient had not experienced Covid-19 prior vaccination. Patient was not pregnant. The female patient received bnt162b2 (BNT162B2), dose 1 on in arm left 17Jan2021 04:00 PM (Batch/Lot # EL8992) at the age of 43-year-old for COVID-19 immunisation. No other vaccine in four weeks. The patient experienced debilitating migraines on 28Mar2021. The event was considered serious as per disability or permanent damage. No treatment received for the event. COVID was tested post vaccination: Nasal Swab, PCR, resulted negative on 14Apr2021. The outcome of event was recovered with sequelae/lasting effects.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of migraine. There is limited information provided in this report.  This case will be reassessed once additional 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.
Heavy, irregular period lasting much longer than usual since getting vaccinated. I am on birth control due to my heavy periods and prior to the Covid vaccine, my periods were very regular and light, lasting approximately 3 days. They are not coming early, late, very heavy with cramping, back pain, lasting 7-8 days.
rash w/itching 3AUG96 approx 10PM;rash on neck @ hairline & no fever @ this time;rash cont to spread to scalp & down center of back;19AUG96 t102.4;MD visit;MD felt rxn to vax;fever d/t infect from scratching;head lice r/t rash;
Mild fever - 100.0 lasting over 24 hours so far, fussiness.
Headache, confusion, hypomagnesemia, cerebral amyloid angiopathy, expressive aphasia, hypertension, increasing frequency of seizure activity, acute encephalopathy, paranoia, hallucinations, brain atrophy,
SWELLING, TENDERNESS, WARMTH AT INJECTION SITE, LOW GRADE TEMP, PAIN TO LEFT AXILLA AREA, FATIGUE Narrative:
Around 9 PM the day I received the vaccine, the unexpected/adverse affect I experienced  was sudden swelling of my face, specifically my eyes (I do not have any dermal fillers just FYI).  It was accompanied by expected side effects including fever, muscle aches and nausea. I also experienced shooting pain throughout my body, but mostly in my arms, and my skin was painful to touch anywhere on my body.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown date the unknown number of patients were vaccinated with ROTATEQ, vial (lot # and expiration date not provided) (dose not reported) (reported as "vaccine"). It was reported that GARDASIL and ROTATEQ were exposed to 34F for 48 hours and (Oka/Merck) VARIVAX was exposed to 32F for 48 hours. The reporter stated that she did not have access to specific patient or vaccine information but she was able to state that all products had been administered post excursion. No adverse effects have been reported by any patient.  It was reported that the unknown number of patients did not seek medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
significant persistent nausea unrelieved by zofran. no vomiting. same reaction with vaccine on 2/7 but reaction is more severe this time causing work loss
After one hour hands, arms, face, and thighs started to tingle and burn. Called doc and they said go to ER if other reactions occur.  Saturday, Sunday, Monday, and Tuesday sympotoms progressed and migrated. has gotten worsening overall symptoms: pins and needles, burning, in face, hands, fingers, arms, feet and toes. Pain in hands, legs, and feet. Twitching in eye.  Cold, numbness in toes, hand function seems off, itching in feet, shivers, vibrations throughout upper and lower body, shaking left and right hand, pain in arms, joints, and legs. Called doc on 01/07/2014 and instructed to go to ER.  Peripheral Neuropathy (ED) diagnosed.
Rash localized to the injection site that was warm to touch.  Advised to seek the attention of a physician or go the ED at the local hospital.
Intense fever 11 hours after the vaccine was administered (2:30 AM) lasting for at least 12 hours. Brought associated aching and fatigue Took Tylenol and drank Electrolyte beverages to manage the fever, along with rest.
24 hours later, right arm red and swollen (last of immunizations until DT).  Warm to touch, skin taunt.  Advise Tylenol/Motrin and ice.
1 day after vaccine had redness around site, this progressively worsened and enlarged and 3 days after vaccine he had fever, headache, pain.
tested positive for covid; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiry date not reported) via unspecified route of administration on 05Apr2021 as single dose for COVID-19 immunization. The patient medical history, concomitant medications were not reported. On 14Apr2021 patient  tested positive for Covid  but believes he could have potentially had it a day before the official results. he would like to know if the vaccine can give you positivity (referring to covid test). He wanted to know when he could get his 2nd dose and whether he needs to. The outcome of event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Administration of expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 19-year-old male patient who received HBV (Engerix B) (batch number p7294, expiry date 3rd January 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th February 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 14th February 2022, unknown after receiving Engerix B and Engerix B 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 details were provided as follows: The patient was inadvertently administrated an expired dose Engerix B, which led to expired vaccine used. No further events were reported.  The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter.
Dry, persistent cough, chills, body ache and headache (flu like symptoms).  Home treatment of plenty of water, orange juice, hot green tea,  ibuprofen and  lots of sleep.  Symptoms only lasted 1 day.  The 2nd day after the vaccine, there were no more symptoms.
Mom noticed she was hot and feverish early this morning about 2:oo AM, and has vomited twice and has general malaise. Her left arm is swollen and red. She has been given tylenol for fever which helps but patient says she still do not feel well.
cough, sore throat, congestion, fever 102.6, 100.5 at home last friday starting 12/24/21
my best friend who died a week after getting Pfizer's death shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A male 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: DEATH (death, medically significant), outcome "fatal", described as "my best friend who died a week after getting Pfizer's death shot". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course (Additional information): the reporter lost his best friend who died a week after getting Pfizer's death shot.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300001872 same reporter and suspect drug/different patient and AE;; Reported Cause(s) of Death: my best friend who died a week after getting Pfizer's death shot
A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Global Medical Information (GMI) (Reference number- 00564905) and transmitted to Sanofi on 16-Apr-2021.  This case involves a 15-month-old female patient who received an expired 0.5 mL dose of HIB (PRP/T) VACCINE [ACT-HIB]( lot UJ137AAA and expiry date: 06-Mar-2021) via an unknown route in an unknown administration site for prophylactic vaccination on 16-Apr-2021 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for prophylactic vaccination.  The caller wanted to know the efficacy and if there are any issues since that expired vaccine was given.  This was a case of actual medication error due to expired vaccine used (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 holders compliance with the requirements set out in 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.
Fever, eyes swelled and drained fluid, hives, aches, throat swelling/difficulty breathing.
Bad Chills (did not want to get out of bed in the morning) & Fever up to 102.5 and weak for 48 hours. Periodic headaches from dull to severe for 72 hours.  Occasional quick (not lasting) stomach pain first 12 hours. Cloudy vision morning after for about 20 minutes
Fever of 101 starting the day of shot, night sweats, lethargy -  all symptoms resolved after 2-3 days.
Rash below the injection site; Soreness at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE RASH (Rash below the injection site) and VACCINATION SITE PAIN (Soreness at the injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash below the injection site) and VACCINATION SITE PAIN (Soreness at the injection site). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] on 28-Jan-2021 for Vaccination site rash and Vaccination site pain, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE RASH (Rash below the injection site) and VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
I started to fell numb around my body and my waistline; It is itchy it is like a red rashes not too many but it is so painful; my right side below my belly it is panful and has rashes; It is itchy it is like a red rashes not too many but it is so painful; my right side below my belly it is panful and has rashes; It is itchy it is like a red rashes not too many but it is so painful; my right side below my belly it is panful and has rashes; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer stated, " I got this vaccine (COVID Vaccine) 17Dec and I just found out today that I should have those, I put it on my app every day that they sending you message and how you feel and everything but after the vacation went up in (state), I have this vaccine and 28 or 27 I started to fell numb around my body and my waistline and then I went to ER and then after that it started itchy and then when it is itchy it is like a red rashes not too many but it is so painful and tomorrow I am going to have a vaccine second shot, I was thinking is that cause of the vaccine, the Pfizer that I had." When paraphrased the concern, consumer stated, "And the rashes are painful, this is my experience. I have never experienced this before. This side, my right side below my belly it is panful and has rashes and when I get up in the morning and this bothering me. I have another vaccine tomorrow, is that from the vaccine? I have information here, the pink form that they gave that has fever, diarrhea, allergy, short breath but this is not there so I am asking what is happening." The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt received DTaP, PREVNAR on Rt leg & PROQUAD, IPV on Left leg on 4/19/11. Developed red, swollen, painful local reactions at site - (L) leg was 3cm but (R) leg was 13 x 14 cm area of redness, induration, tender.
Pt vaccinated with Pneumovax 23 hx of COPD within 1 hr of vaccination, developed swelling of her upper lip.
Seen in ER at hospital. Term stated in Autopsy report is Asystole. Additional CoStarts from Discharge Summary rec'd on 07/25/2005 -- Apnea, Stupor, heart arrest.  Autopsy Report received which stated COD as interstitial pneumonitis c/w viral pneumonia.  Manner of death: natural.