chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe injection sure pain; Soreness in upper body; Headache; Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11Oct2021 19:30 (Lot number: FE3590) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Penicillins" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: DIOVAN HCT; AMLODIPINE. Past drug history included: Levofloxicin, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9264, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM), administration date: 26Jan2021, when the patient was 53 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: FE3590, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 16Feb2021, when the patient was 53 years old, for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 12Oct2021 03:00, outcome "recovering", described as "Severe injection sure pain"; PAIN (non-serious) with onset 12Oct2021 03:00, outcome "recovering", described as "Soreness in upper body"; HEADACHE (non-serious) with onset 12Oct2021 03:00, outcome "recovering", described as "Headache"; FATIGUE (non-serious) with onset 12Oct2021 03:00, outcome "recovering", described as "Tired". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain, pain, headache, fatigue.  Additional Information: Therapeutic measures were taken as a result of events included Advil and tylonel. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
patient received Covid19 dose 2 on 10/23/22 and symptoms began 10/23/22 evening. Patient had fever, high of 104F, x 3 days + body aches, stomach aches at this time  The first COVID19 dose was given 8/24, Patient ended up having a fever for 8 days following dose 1. He received COVID19 dose 1 most likely during active Covid infection. Other symptoms included: + b legs and arms achy  + jaw achy + nauseous + poor appetite + eye redness + keeping his head down + dry cough, improving - cough waking pt up at night + mild runny nose
Patient presented to ED on 8/8/21 with complaints of progressive weakness and falls over the last several weeks. Patient found to be COVID+ in ED and admitted with differential diagnosis including nstemi, stemi, pneumothorax, pneumonia, chf, uti, ich, deconditioning, aki, dehydration.  Presented with occasional cough, no chills, vomiting, diarrhea, and not short of breath. As of 8/9/21, he is afebrile and oxygen saturation is 94% on room air. Treated with empiric antibiotics for suspected CAP, no other interventions related to COVID diagnosis.
This spontaneous report as received from Registered Nurse refers to unspecified number of patients of unknown demography. On an unknown date the patients were vaccinated with improperly stored RECOMBIVAX HB lot # M022077 (expiry: 01-MAR-2019). No adverse effects were reported. No product quality complaint (PQC) involved. This case is linked to cases 1608USA005032 and 1608USA012663 (same reporter link). Additional information has been requested.
Redness at the site of injection about 1 inch in diameter, hard, tender & hyperemic on the right thigh.
Erythema multiforme rash 24 hrs p/MMR recvd; lasted approx 10 days; no treatment required; pt recovered spontaneously;
Raised lymph node supraclavicular area about 5 cm. Had similar rx - 2010. No epitrochlear, axillary or infraclavicular lymph node enlargement (Rt) arm. No erythema or inflammation right deltoid injection.
No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 24-JUN-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # S000132 and expiry date 02-JAN-2021) and no adverse effects were reported(product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown. No PQC found.  This is one of several reports received from the same reporter.
The same day post vax, the pt developed pain and swelling at injection site. He also experienced headache for 72 hours and generalized malaise.
sick for day and a half; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for day and a half) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced ILLNESS (sick for day and a half). At the time of the report, ILLNESS (sick for day and a half) outcome was unknown. Not Provided          No concomitant medications and treatment reported.    This case was linked to MODERNATX, INC.-MOD-2021-068773 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-068773:
administered expired doses of DAPTACEL with no reported adverse event; Initial information was received on 22-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA258195 (CLUSTER).  This case involves a 1 years old female patient who received an expired doses of diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB vaccine (HIB) for Prophylactic vaccination.  On 17-Aug-2023, the patient received an expired dose of suspect diphtheria-15/tetanus/5 ac pertussis vaccine Suspension for injection (strength: standard) at dose of 0.5 ml (lot number: C5893AA, expiration date: 21-Jun-2023) via unknown route in unknown administration site for Immunization (immunisation) with no reported adverse event (expired product administered) (latency: same day).  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event administered expired doses of daptacel with no reported 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 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.
More than moderate muscle and joint weakness for weeks now; More than moderate muscle and joint weakness for weeks now; weakness of legs, knees, hips; weakness of legs, knees, hips; now after 2, continues to be painful; This is a spontaneous report from a contactable consumer (patient). A 66-year-old non-pregnant female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EN6201) via an unspecified route of administration on 10Feb2021 (at the age of 66-years-old) as a single dose in the right arm and received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EN6198) via an unspecified route of administration on 03Mar2021 (at the age of 66-years-old)  as a single dose in the left arm, both for COVID-19 immunization. Medical history included known allergies: mild hay fever and some antibiotics- mild from unspecified dates and unspecified if ongoing. Other medical history was also reported as "normal aging". The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were none. It was reported that there were no other medications taken within two weeks of the COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. In Feb2021 the patient experienced more than moderate muscle and joint weakness for weeks now, weakness of legs, knees, hips and now after 2, continues to be painful. The events were reported as disabling. The clinical course was reported as follows: More than moderate muscle and joint weakness for weeks that was slight after vaccine dose 1, and now after dose 2 it continued to be painful with weakness of legs, knees, hips. The patient could usually walk normally, healthy. She was getting ready to report to her physician. The symptoms seemed disabling, she hoped it was temporary. No treatment was received for the adverse events. The clinical outcomes of the events more than moderate muscle and joint weakness for weeks now, weakness of legs, knees, hips and now after 2, continues to be painful were not recovered/not resolved. The patient was not tested for COVID-19 since vaccination.
Given 0.25mL of Bivalent Moderna Vaccine, no apparent injury.
This spontaneous report as received from a Licensed Practical Nurse refers to unspecified patients of unknown ages and gender. On an unknown date unspecified patients received second dose of GARDASIL (dose, indication and route of administration were not reported) (lot number unspecified) late, beyond the recommended two months. Concomitant medications were not reported. No adverse events were reported. Additional information has been requested.
LEFT EYE DRY AND RED ON MARCH 19TH; FACE SWOLLEN, NUMB AND DROOPY THE 20TH. PATIENT FOLLOWED UP WITH PROVIDER A WAS DIAGNOSED WITH BELLS PALSY
Information has been received from a physician concerning a 17 year old female who on 02-DEC-2008 was vaccinated with the first dose of GARDASIL (lot no. and route not reported) and MENACTRA.  On 12-DEC-2008 when the patient was done with the vaccination, she left the room and passed out in the elevator.  The physician reported that the patient did not have injury when she passed out.  The patient was brought back to the clinic and after a few minutes she was fine and left the clinic.  Additional information has been requested.
4 am (after getting the vaccine) woke up heart pounding and couldn't breathe. It started to affect his MS.
Cough; Not feeling well; This is a spontaneous report from a contactable consumer. A 64-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 28Feb2021 at a single dose for covid-19 immunization and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 24Mar2021 at a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced cough and not feeling well, when she coughs it does not stop. Reporter wanted to know what tests they should do to see if his wife has covid or not. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
101+ fever for 24 hours,  shaking, body aches, chills, vomiting, nausea, lack of appetite
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 11May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in right arm for covid-19 immunisation; 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 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Aug2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Aug2022) positive. Mucinex were taken from 03Aug2022 to 11Aug2022 as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within 20-30 min after injection while drive, blurred vision unable to think clearly, 5-10 after that felt like pins and needles on arm where injection rec'd travels to neck. Drove home during this episode, then went to ER.
One week following vaccination patient developed fatigue, myalgias, and arthralgias without any other signs or symptoms of acute illness. Seen in the office on this date, with persistent symptoms
INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 16 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the patient experienced inappropriate age at vaccine administration. On 08-MAY-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inappropriate age at vaccine administration and off label use was not reported. This report was non-serious.
liquid running down the patient's skin/No AE; syringe broke at the point where the barrel and luer lock meet; Initial information received on 15-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 16 years old female patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT], while vaccination nurse observed vaccine liquid running down by patient's skin.  The medical history, medical treatments, vaccinations and family history were not provided.  On 07-Nov-2019, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot UJ294AA Expiry Date: 30-Jun-2020] via intramuscular route in the right deltoid.  It was a case of actual medication error due to Exposure via skin contact.  It was also the case of Syringe issue.   At the time of report no adverse event was reported.  Patient was re-vaccinated immediately.  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 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.
Initial information received on 19-Jul-2018 regarding an unsolicited valid non-serious case received from a patients mother. This case involves male patient (age not reported) who experienced hives all over his arm, while he received vaccine DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE produced by unknown manufacturer lot number not reported. On an unknown date, the patient developed a non-serious hives all over his arm (urticaria) following the administration of DIPHTHERIA and TETANUS AND NOS PERTUSSIS VACCINE. (Other relevant tests included no lab test.) Final diagnosis was hives all over his arm. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for hives all over his arm.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored PNEUMOVAX 23 lot# 1013428, expiry date: 03-FEB-2017 (dosing details were not reported). No adverse symptoms were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
5 days after, vomiting, 1/2 a day- then non raised rash began at midsection traveling to extremities. Took apx. one  month to clear up. Child was lethargic during this time. Rash did not itch. Under skin surface
TDAP BOOSTRIX (0.5mL PFS)  : 0.5 mL (dose no:1) given by APRN on Right Deltoid    Chicken Pox Varivax Vaccine  : 0.5 mL (dose no:1) given by APRN on Left Arm    Meningococcal MCV4O (MENVEO)  : 0.5 mL (dose no:1) given by APRN on Right Deltoid At ~ 11:12 am, ~ 2 minutes after vaccines administered, writing NP was scanning vaccine forms and heard & then observed pt's limbs bumping up against the exam table, and heading slowly toward the ground. Pt was assisted to the floor, positioned on his left side. He was unresponsive for ~15 seconds. Writing NP did not observe pt hitting his head. An individual called EMS. After ~ 20 seconds, pt opened eyes and said he was "ok". Breathing spontaneously, color unchanged, skin warm & dry. Answered questions correctly to orientation, moved all extremities. Denies that he hurts anywhere. Moist paper towel applied to pt's forehead and pt able to move all extremities. Pt denies eating breakfast. Denies ever having passed out in the past with vaccines. Pt remained in supine position on the floor for several minutes as a precaution. EMS arrived at 11:22am. Pt assisted to chair without difficulty. Writing NP took VS BP 104/62, HR 79, O2 sat 100%. Water given. Pt sipping on water. EMS checked BG-86. Pt denies wanting to go to hospital when asked by EMS. Pt observed for an additional 30". Pt reported feeling fine. Ambulating without difficulty. Brother is accompanying pt home.
Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.
Note for KINRIX regarding dose #: DTaP #5, IPV #4. Approximately 10 minutes after vaccination, parent reported rash and provider noted an approximate 1 cm raised erythematous area, with ~ 3 mm erythema around this. Area is to the right of KINRIX vaccine site, and above the VARIVAX vaccine site on L. lateral upper arm. NO: dyspnea, swelling of face, tongue or wheezing, dizziness, weakness. Cool cloth was applied and parent was advised to apply cool compress x 1-2 weeks, to monitor closely and call on call or go to ED if any other symptoms. Parent called the following day (8/3/17), reported that child has another lump on arm, stated that arm was red and swollen. Mom had tried ice and TYLENOL. Parent advised to schedule appointment if symptoms worsened, offered appointment next day but parent declined. Parent brought child to ED 8/3/17 and left upper arm was noted to be warm, erythematous and painful, "rash present". Diagnosed as cellulitis and prescription for BACTRIM was given. 8/8/17 follow-up call made and parent reports that patient is doing fine now.
She has VVS.  Fainting periodically. Convulsions  During her episodes.     2/16/23 Dr patient was taken to hospital for fainting/syncope   2/27/23 Hospital. Dr. Patient was taken there for syncope. EKG. Echo gram stress test
Case number PHEH2014US019449 is an initial spontaneous report received from a pharmacist on 25 Sep 2014. This report refers to a 17 year old female patient. Her past medical history and concomitant medications were not reported. On 24 Sep 2014, she received FLUCELVAX (batch number: 017031A) intramuscularly at the age of 17 years. No adverse events were reported following this maladministration (inappropriate age at vaccine administration).
chills, fever, body aches all over, severe back pain and pain like a bruise at shot site
Herpes zoster L1 distribution  with  both sensory and motor findings. Abdominal pseudohernia and Ogilvie's Syndrome
pt recvd vax; 6 hrs later devel redness, swelling & pain at inject site; fever of 101.8, lasted for 48 hrs;
Redness, swelling, heat, bruising & pain at injection site,  along with headache. Patient also stated a red band from injection site down the back of her arm. Patient reported symptoms two days, (48 hrs.), after receiving vaccine. Instructed patient to report symptoms to her physician. Followed up with patient 24 hrs. later. Patient reported that Dr. had prescribed antibiotic, and that the symptoms where subsiding.
patient received Adacel on 29Jun2014, and then again on 10Jul2019, the dosing interval between two injections of Adacel was less than the labelled 8 year interval; Initial and live follow-up information received on 16-Jul-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 34 years old female patient who was vaccinated with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] first dose on 29-Jun-2014 and second 0.5 ml dose on 10-Jul-2019 with lot: C5585AA (expiry date: 06 Mar 2012, route and site of administration not reported) and the dosing interval between two injections of Adacel was less than the labelled 8 year interval.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to inappropriate schedule of vaccine administration.  It was unknown if 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 set out in 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.  Information on the batch number was requested.  List of document held by sender: none.