chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left chest pain and left lower jaw pain. Tested for heart attack but everything was negative. Pain at injection site was excruciating and lasted for 4 days. Shoulder pain improved each day. Chest and jaw was gone by 11:30 pm that first night.
Pt. received a Tdap on 3-16-11 and returned on 3-23-11 with redness, swelling & hardness in injection site. It has been this way since receiving her inj.
Presented with 1 month of nausea and occasional vomiting for the past 4 weeks since receiving J&J vaccine with acute worsening 2-3 days prior to admission with multiple episodes of emesis daily. Patient has history of GERD and cataracts. Complaint of lethargy and itchiness for the last month. Patient sought treatment at ER and was admitted. Wife noticed jaundice on morning of admission. Found to have transaminitis and hyperbilirubinemia on admission with some improvement after IV fluids. Patient admitted to hospital for 4 days. Note: Patient had been treated for Hep B infection for 6 months in 2007 with tenofovir
Pain level 7 in Neck on left side. Numbness/Tingling in entire left arm. Loss of strength in left arm. Lack of sleep due to pain.
Prior to vaccine with a few weeks of weight loss, fatigue, and mild cough. Two days after vaccination with headache, self resolved. Then around 7/17 she developed tactile fevers, increasing fatigue, and headache. On 7/20 PM she had acute onset of altered mental status- she was screaming and disoriented. She was taken to the Hospital emergency department on 7/21 AM.   Work up initially concerning for ADEM, although subsequent imaging consistent with miliary TB with CNS disease (tuberculomas).   Patient was exposed to grandmother with MDR pulmonary TB in 2018. Patient was prescribed treatment for LTBI (QuantGold pos but negative CXR) but unclear if she took it.  Currently started on therapy for MDR TB and remains hospitalized.
Report 2001027157-1 describes eye burning in a 40 year old female who, while administering an injection of Infanrix, had some of the vaccine squirt into her eye. Medical history, concurrent conditions, and concurrent medications were not specified. On 11/14/2001, a nurse who was administering Infanrix to a vaccinee, had some of the vaccine squirt into one of her eyes. It was not specified which eye was involved. Her eye started to burn. She flushed the eye with water and the burning resolved. The most recent info received on 04/22/2002, indicated that the nurse "had no ill effects."  A 15-day follow up report received 05/28/2003 adds no new info.
body ache; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "body ache"; HEADACHE (non-serious), outcome "unknown", described as "Headache".  Additional Information: Reporter stated that the patient got her second shot yesterday and has body ache and headache is it alright to take Tylenol.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021326264 same reporter/drug/AE, different patients.
No adverse event; A patient was administered with the bivalent vaccine instead of the monovalent vaccine for his 1st dose in the primary series.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (A patient was administered with the bivalent vaccine instead of the monovalent vaccine for his 1st dose in the primary series.) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.   Concurrent medical conditions included Multiple sclerosis.    On 06-Nov-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Nov-2022, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (A patient was administered with the bivalent vaccine instead of the monovalent vaccine for his 1st dose in the primary series.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (A patient was administered with the bivalent vaccine instead of the monovalent vaccine for his 1st dose in the primary series.) 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 WRONG PRODUCT ADMINISTERED (A patient was administered with the bivalent vaccine instead of the monovalent vaccine for his 1st dose in the primary series.).    No concomitant medications were reported.  Patient was treated for nerve condition at HCP office. The neurological condition has remained stable post vaccine administration.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2023: Live significant Follow-up appended: Product information, event information, narrative updated
Around 7:30 PM I arrived home from work and started feeling very lethargic, extremely tired. Around 3 AM I started running a temperature (100.5F) and started with the chills and body aches. I still feel very tired.
Client fainted after receiving HPV4 vaccine. Fl up done by RN and staff. Client recovered after 15"-20".
This spontaneous report as received from a nurse practitioner refers to a patient (gender and age not reporter) which was vaccinated with PNEUMOVAX23 (dose and route not provided) which was exposed to 12C for 192 hours. No adverse effect reported. Lot number H022281 is an invalid lot number for PNEUMOVAX23. This is one of several reports received from the same source. Additional information is not expected.
Severe and prolonged pain throughout upper arm for almost one month at this point and still persisting. Inability to move the arm without pain.  Limited range of motion due to pain.  Today is the 27th consecutive day with pain and limited range of motion.
Lesions over body. Started as small bumps then grew into large patches ones hands, arms and legs. All areas infected have swollen. Can not make fist with right hand
severe muscle pain; chills; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Jan2022 17:00 (Lot number: FJ1614) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "diabetes" (unspecified if ongoing); "cad" (unspecified if ongoing); "thyroid" (unspecified if ongoing); "back issues" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: TRESIBA; ISOSORB MONO; SIMVASTATIN; METOPROLOL TARTRATE. Past drug history included: Tetanus for Immunisation, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: FC3181, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM, Brand: Pfizer), administration date: 14Aug2021, when the patient was 75 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: FA7484, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM, Brand: Pfizer), administration date: 22Jul2021, when the patient was 75 years old, for COVID-19 immunization. The following information was reported: MYALGIA (non-serious) with onset 16Jan2022 16:00, outcome "recovering", described as "severe muscle pain"; CHILLS (non-serious) with onset 16Jan2022 16:00, outcome "recovering", described as "chills"; NAUSEA (non-serious) with onset 16Jan2022 16:00, outcome "recovering", described as "nausea".  Additional information: Known allergies were reported for tetanus. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Tresiba, isosorb mono, simvastatin, metoprolol tar medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Twitching up and down my left arm, where the shot occurred, and sometimes my eyes. I?m not sure about the eyes since that?s happened before, but the left arm is consistent, visible, and once every few seconds.
SkinRash, Rash Rash to injection site 4-5 day after dose and rash lasted for 2 days. Rash was raised and itchy and warm. Resolved after 2 days.  Narrative:   Other Relevant History:
Mom called reporting fever 102.7 during night after receiving vaccines via triage. On 12/7/04, mom was told to give Tylenol every 4 hours and to call for worsening symptoms. Did not hear from mom again. Baby was brought into ER via EMS on 12/22/04 with unknown cause of death. Autopsy Report received on 2/02/2005 states SIDS.
29AUG90 mother called, child had T since approx. 2 days /p vaccine up to 40 deg. C. Pt had coughing since 23AUG. On PE 29AUG90 pt had both tympanic membranes red, dull. Rest of PE WNL. Went to Hosp. & DX /w pneumonia by Xrays,chest.
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 41-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 14-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).    Concomitant medication was not reported.  Patient ID was reported as Unknown.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that breakdown of doses were reported as 51 doses from batch number AS7140C and 60 doses from Batch number AS7148B.  Treatment medication was not reported.
Full body rash since 1/7/2021. Itching. I took a steroid and used steroid cream
The flu shot put an older friend of mine in a Wheel chair; Initial information received on 02-Dec-2020 regarding an unsolicited valid non-serious case received from a patient's friend (consumer) via social media.  This case involves patient (unknown demographics) for whom the flu shot put the patient in a Wheel chair (wheelchair user) while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was put in a Wheel chair (wheelchair user) unknown latency following the administration of INFLUENZA VACCINE.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown.  There will be no information available on the batch number for this case.
Breakthrough case admission after 4 vaccines  Moderna 1/6/21 Lot# 026L20A;  Moderna 2/4/21 Lot# 029L20A;  Moderna 2/9/22 Lot# 042J21A;  Moderna 11/23/22 Lot# 050D22A
Patient describes right arm soreness that radiates to Rt pectoral muscle can't lay on arm, tender to touch & warm. Symptoms x 6 plus days.
Developed chest pain and numbness on the left side of the body.  She explained it felt like lidocaine was injected all over the left side of her body.  The symptoms resolved on Wednesday, May 19th when she was receiving testing for her condition.
arm hurt only a little bit; This is a spontaneous report from a contactable consumer(patient). A 66-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. The patient was 66 years old and went to the stadium name yesterday on 11Jan2021 and there were 1000's of people there. The patient got her first dose of the vaccine and they gave her an appointment card for the first of February. The patient was fine by the way, her arm hurt only a little bit in Jan2021. She went back to that vaccine assistant thing to make an appointment. It was a computerized system for making an appointment. It generates a QR code. But she was not sure that she had an appointment for her second dose. The outcome of the event was unknown.   Information on the Lot/Batch number has been requested
Pt developed an injection site reaction characterized by induration measuring 5 cm by 6 cm, redness and swelling.
a  terrible diarrhea; nauseated/nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (a  terrible diarrhea) and NAUSEA (nauseated/nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced NAUSEA (nauseated/nausea). On 14-Aug-2021, the patient experienced DIARRHOEA (a  terrible diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at a dose of 1 dosage form, 2 tablets. On 15-Aug-2021, DIARRHOEA (a  terrible diarrhea) had resolved. At the time of the report, NAUSEA (nauseated/nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient mentioned of taking 2  tablets of Imodium that was  given by a nurse from her  doctor's  office, and it helped to treat her  diarrhea. Patient took doctor pepper and another medication for nausea. Patient  is on some concomitant medications like: Medication for Epilepsy.   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: additional info received with updated event information
ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/18/2022 CKD STAGE 3A (GFR 45-59) HYPOXIA 12/2/2022 CKD STAGE 3A (GFR 45-59) ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/18/2022 ATRIAL FIBRILLATION, PAROXYSMAL HYPOXIA 12/2/2022 ATRIAL FIBRILLATION, PAROXYSMAL
After patient received this vaccine dose, it was discovered that the vial had been stored outside of the recommended temperature range calling into question its efficacy  After conferring with immunization experts it was determined that this dose needs to be repeated.  Patient was contacted by the person completing this form and made aware of this information.  The patient plans to repeat dose on 4/21/2021.
Hospital employee received a dose of hepatitis B (Engerix-B) vaccine by her department flu champion instead of receiving a dose of Flulaval. Employee Health attempted to reach employee by phone to disclose the discover of the error, but there was no answer and a voice message was left requesting to call back to Employee Health.
The patient received the original Pfizer covid vaccine instead of the bi-valent Pfizer covid vaccine by mistake.
Right after the shot I felt like my throat closed up, but went away. I felt a little dizzy as well. Within an hour the right side of my face and ear started to hurt, almost like it felt burnt, The nerve endings was super sensitive and has still not gone away. That night I didn't feel good, tired and out of it. On the third day I woke up with a rash on various parts of my body and moved to my eye lids as well. I called for a telehealth, and asked for a low dose steroid and he said not because I would "disrupt my immune response".  I'm still having issues.
Pt was given MMR vaccine on 11/24/14 (Neg Rubeola titer 11/5/14 - Mumps and Rubella were +); reports that on 12/6/14 she developed rash to chest and trunk, was diagnosed with "German Measles" (Rubella) by PCP on 12/8/14. Reports fever of 102.8; no meds from PCP per pt.
patient received HIB portion of Pentacel, DTaP/IPV portion was not given and the HIB  was administered with a solution used for frozen vaccines, maybe sterile water with no adverse event; Initial information regarding this unsolicited valid non-serious case via Medical Information  (reference number: 00317786) was received from a nurse and transmitted to Sanofi 15-Oct-2020.  This case involved a 6 months old female patient who received HIB portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot: UJ227AAA, expiry date: 23-Apr-2021), DTap/IPV portion was not given and the Hib was administered with a solution used for frozen vaccines, maybe sterile water via unknown route at an unknown administration site for prophylactic vaccination (product preparation error), on 07-Oct-2020, via intramuscular route in the left thigh for prophylactic vaccination.  Relevant medical history, past medical treatment, vaccination details and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL), HEPATITIS B VACCINE (HEPATITIS B VACCINE), PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ).  It was a case of actual medication error due to product preparation error.  At the time of report, no adverse events were 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 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.
fever, chills, body aches, nausea, headache, fatigue tylenol
Pt recv vax on 2/5/99; on 2/6/99 pt exp 2 seizures w/ fever (104.9); 1st seizure-x2 min, pt limp & unresponsive; 2nd seizure-x 5-7 min, tonic clonic, eyes rolled back, clenched teeth; dx=ear infection; tx=Amoxicillin
Generalized aches and chills, states "wasn't right", warm to touch, nausea, swelling of arm of injection site (slightly) and states felt "woozy".
Small nodule formed immediately after injecting vaccine. Patient reported no pain. Did not feel warm. Advised patient to ice it, and take ibuprofen and benadryl when she got home. Called patient 4 hours later to check on her. She reported nodule had gotten smaller, and had no pain or shortness of breath. Counseled patient to monitor nodule and contact her doctor if it worsened or did not improve.
ARM SWELLING AND FEVER - TEMP ( UNKNOWN ). Patient took TYLENOL ALTERNATING WITH IBUPROFEN .
Patient felt faint; lost consciousness; hypotension. First reading was too low for recognition; second reading 76/41 and pulse of 28; 4 minutes later, third reading 90/58 and pulse of 81. Patient appeared to have a small seizure (inhaling hard for air, loss of body coordination, injection site arm muscles seized and locked). 911 was called and evaluated patient. She declined further treatment at hospital. Eighteen hours later, patient had slight flu-like symptoms, but was feeling much better. Patient reported follow-up appointment with PCP scheduled for 5/24/2021.
FEVERISH; NAUSEA; BLOOD PRESSURE WAS 181/80; COLD HANDS AROUND 18:00; FAST HEART RATE; WOOZY; MORE TIRED; 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 admin not reported, batch number: Unknown) dose was not reported, administered on 18-MAR-2021 11:00 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 MAR-2021, the subject experienced woozy. On MAR-2021, the subject experienced more tired. On 18-MAR-2021, the subject experienced blood pressure was 181/80. On 18-MAR-2021, the subject experienced cold hands around 18:00. On 18-MAR-2021, the subject experienced fast heart rate. On 18-MAR-2021, the subject experienced nausea. Laboratory data included: Blood pressure (NR: not provided) 181/80 (unit not provided), and Heart rate (NR: not provided) 135 (unit not provided). On 18-MAR-2021 21:00, the subject experienced feverish. Laboratory data included: Body temperature (NR: not provided) 102.1 (unit not provided). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood pressure was 181/80, cold hands around 18:00, woozy, feverish, nausea, and more tired on 20-MAR-2021, and fast heart rate on 19-MAR-2021. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
MMR vaccine administered intramuscularly in the right thigh, instead of subcutaneously.
She got her vaccine, had no initial problems with the vaccine.  After the last one she did not have any outstanding reactions or anything.  On 11/12/22 she woke up in the morning without realizing she was sick and her speech was slurred, her vision was off, her balance was way off.  A friend came and said she had a stroke and took her to the hospital.  They did a work up and informed her that she had a stroke . The next day the symptoms regressed and she was able to go home.   They did lab work and all seemed to be OK.   She is 83 years old and has never been on any medication for anything, and has no history of any issues.  She is a very active person.  She did not receive any medication for someone who had a blood clot stroke.  She has been taking 1 aspirin a day since she had the stroke.  She still notices that she feels like she is a little weaker as she used to be, and cannot lift as much weight was as she used to.  Her balance is off a little bit, she can walk fine but if somebody bumps her she stumbles.  Her thinking process is back to normal, and feels more than adequate.  She otherwise is not having any other problems.   She has an appointment to see a neurologist in February.   All of her vaccines were Pfizer and kept them under one brand name, and had no issues with any of the other vaccines.