chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left arm started to itch; Little red marks (dots) at the injection site; Left arm felt very warm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Left arm felt very warm), PRURITUS (Left arm started to itch) and VACCINATION SITE ERYTHEMA (Little red marks (dots) at the injection site) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concomitant products included PREDNISONE for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 04-Feb-2021, the patient experienced FEELING HOT (Left arm felt very warm). On 15-Feb-2021, the patient experienced PRURITUS (Left arm started to itch) and VACCINATION SITE ERYTHEMA (Little red marks (dots) at the injection site). On 06-Feb-2021, FEELING HOT (Left arm felt very warm) had resolved. At the time of the report, PRURITUS (Left arm started to itch) and VACCINATION SITE ERYTHEMA (Little red marks (dots) at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: NNI
Patient states dizzy, hot and nausea within a few minutes after getting last shot and lasted about 2 minutes. Laid patient down, checked BP 80/40 and gave juice. Patient improved.
Severe pain in left shoulder and upper arm; severe pain in left shoulder and upper arm; Tingling sensation; Throbbing pain in left bicep/Flexing or extending arm increases the pain; This is a spontaneous report received from a contactable consumer (patient). A 68-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EM9809) via an unspecified route of administration in Left arm on 08Feb2021 at 03:45 PM as single dose for COVID-19 immunisation. Medical history was not reported. No known allergies. Concomitant medications were none. No other vaccine received in four weeks. No other medication received in two weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) via an unspecified route of administration in left arm on 18Jan2021 at 03:45 PM (at the age of 68 years) as single dose for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination. On 09Feb2021 at 04:00 PM, the patient experienced severe pain in left shoulder and upper arm. Tingling sensation down lower left arm extending to tip of thumb. Throbbing pain in left bicep. Flexing or extending arm increases the pain. No visible redness or skin disruption at needle site. Events resulted in Doctor or other healthcare professional office/clinic visit. So far he received prednisone prescription as treatment. Patient had not tested with COVID post vaccination. The outcome of events was not recovered.  No follow-up attempts are possible. No further information expected.
A week after shot, arm has a large round circle swollen area where shot was given. Circle is hard and red. Painful if pushed. I noticed today around 1PM. No other symptoms.
Patient was hospitalized due to pneumonia; Urinary track infection; Patient tested positive for covid at the hospital with a rapid test; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Patient was hospitalized due to pneumonia) and URINARY TRACT INFECTION (Urinary track infection) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included TORASEMIDE (TORSEMIDE), METOPROLOL TARTRATE (METOPROLOL XL), LEVOTHYROXINE, TAMSULOSIN, APIXABAN (ELIQUIS), METFORMIN, FENOFIBRATE and CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced PNEUMONIA (Patient was hospitalized due to pneumonia) (seriousness criteria hospitalization and medically significant) and URINARY TRACT INFECTION (Urinary track infection) (seriousness criterion hospitalization). On 18-May-2021, the patient experienced COVID-19 (Patient tested positive for covid at the hospital with a rapid test). The patient was hospitalized on 30-Apr-2021 due to PNEUMONIA and URINARY TRACT INFECTION. The patient was treated with TAZOBACTAM (intravenous) at a dose of UNK dosage form and PIPERACILLIN (intravenous) at a dose of UNK dosage form. At the time of the report, PNEUMONIA (Patient was hospitalized due to pneumonia), URINARY TRACT INFECTION (Urinary track infection) and COVID-19 (Patient tested positive for covid at the hospital with a rapid test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2021, SARS-CoV-2 test: positive (Positive) Patient tested positive for COVID at the hospital with a rapid test.         Description: The patient was hospitalized on 30 Apr 2021 due to pneumonia and urinary tract infection. The patient was still in the hospital.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This report refers to a case of Product administration error for mRNA-1273, lot #  031L20A  with associated AEs. Additional information is requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This report refers to a case of Product administration error for mRNA-1273, lot #  031L20A  with associated AEs. Additional information is requested.
patient noticed a "vein" appear on her right thigh immediately following the vaccine administration and then she developed a few other red spots clustered together near the "vein"
19MAY94 had sz & t103; mom called MD; pt was seen by MD 19MAY94 in morning; fine @ that time;
The patient had DTaP administered in left arm/deltoid on 4/29/08.  Today 5/1/08 she developed redness and swelling along lateral border of her left arm.  No fever or pain.
Chills, high fever, muscle aches and pains.  Resolved in 12 hours ( much shorter than the 3 days in vaccine 3)
Guillain Barre Syndrome 05/15/07-records received from facility for DOS 3/26-4/9/07-DC DX: Probably Guillain Barre Syndrome. IVIg therapy. Admitted with ascending motor weakness, paresthesias and diplopia three days prior to admission. Right facial droop, urinary retention lethargy and mild encephalopathy.  HX of traveling across country. Onset of symptoms sudden progressive blurry vision then weakness in bilateral lower extremities with tingling sensations in hands and feet.
expired dose of Daptacel was inadvertently administered/no AE; Initial information received on 10-Feb-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a patient of unknown demographics who received an expire dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] inadvertently (Expired product administered).  The patient medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   On 10-Feb-2020, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5366AA (expiry date: 07-Feb-2020) via unknown route in unknown administration site for prophylactic vaccination.  It was of actual medication error due to expired vaccine used.  It was unknown whether adverse event was experienced or not.  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.
On 6/27/11, RN received call from mother. On PM 6/20/11 fevers, (L) arm swelling; red & bruised from (L) shoulder to (L) elbow. To ER 6/21/11 - ibuprofen ordered. To ER 6/22/11 antibiotics ordered, to pediatrician 6/22/11, antibiotics changed & prednisone ordered. By 6/27/11, child better, without fevers, without swelling.
Chills, body aches, headache, nausea, backache been going on for 24 hours
nausea, chills, pain in abdomen, swelling at site of injection for 12 hours very sick and very intense pain
Shingles (not the first occurrence of shingles for this patient.  However, the most adverse case - extreme burning, itching and pain)
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 17-OCT-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# M044718 and expiration date 07-MAY-2018) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
Nominal; lightheadiness; sore arm; loose bowels; have lymphoedema in upper legs; swelling down to ankles; issues getting body to respond to being awake; This is a spontaneous report received from a contactable Consumer or other non-HCP. The reporter is the patient.  A female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Aug2021 12:00 (Lot number: ew0171) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "Known allergies: Cipro"; Streptomycin, reaction(s): "Known allergies: streptymicin". The following information was reported: APHASIA (non-serious) with onset 01Aug2021, outcome "recovered", described as "Nominal"; DIZZINESS (non-serious) with onset 01Aug2021, outcome "recovered", described as "lightheadiness"; PAIN IN EXTREMITY (non-serious) with onset 01Aug2021, outcome "recovered", described as "sore arm"; DIARRHOEA (non-serious) with onset 01Aug2021, outcome "recovered", described as "loose bowels"; LYMPHOEDEMA (non-serious) with onset 01Aug2021, outcome "recovered", described as "have lymphoedema in upper legs"; JOINT SWELLING (non-serious) with onset 01Aug2021, outcome "recovered", described as "swelling down to ankles"; SOMNOLENCE (non-serious) with onset 01Aug2021, outcome "recovered", described as "issues getting body to respond to being awake". Therapeutic measures were not taken as a result of aphasia, dizziness, pain in extremity, diarrhoea, lymphoedema, joint swelling, somnolence. Additional information: The patient did not receive any other vaccine in four weeks and Other medications in two weeks. The patient did not had COVID prior vaccination and post vaccination, patient had not tested with covid 19. Scary concerning - day 2 - week 13 -issues getting body to respond to being awake. Internally, She was awake, aware and alert but could not get my body to respond. Started out taking an hour or so to get body to "wake" in respond to mind being awake. For first couple of weeks, then the time frame would decrease each week till she was waking normally now 13 weeks after taking shot 1. Discussions with doctor was not to take dose 2 since that is the dose symptoms tend to occur versus dose 1. No follow-up attempts are possible. No further information is expected.
pt recvd vax 23FEB96 & treated @ hosp ER 25FEB96 rash 3-4" wide @ inj site (lt leg); lt leg swollen, sore & emitting heat;recovered 26FEB96;
Patient also stated that there was a chap in another country bled to death due to brain haemorrhage due to Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): MDGB22-00941 (MODERNA).  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: CEREBRAL HAEMORRHAGE (death), outcome "fatal", described as "Patient also stated that there was a man in another country bled to death due to brain haemorrhage due to Pfizer". The patient date of death was unknown. Reported cause of death: "Patient also stated that there was a man in another country bled to death due to brain haemorrhage due to Pfizer". It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Patient also stated that there was a chap in another country bled to death due to brain haemorrhage due to Pfizer
Headache, neck pain & pain at injection site starting approx 2 hours after injection and lasting until bedtime on 12/18/20.  Headache, swollen glands, neck pain, fatigue, nausea and fever beginning morning of 12/20/20 and resolved 12/22/20.
30 to 40 mins after injection an numbness creeped up my shoulder from the injection site; Numbed the left side of face and throat.; Numbed in left side of face and throat.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6198) via an unspecified route of administration in the left arm on 17Mar2021 at 14:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity. The patient had no known allergies to medications, food, or other products. Concomitant medications included citalopram (MANUFACTURER UNKNOWN), naproxen (MANUFACTURER UNKNOWN), baclofen (MANUFACTURER UNKNOWN), multivitamin (MANUFACTURER UNKNOWN) and calcium (MANUFACTURER UNKNOWN); all taken for unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Mar2021 at 15:00, 30 to 40 minutes after vaccination, the patient experienced numbness creeped up her shoulder from the injection site, and numbed the left side of face and throat. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events numbness creeped up her shoulder from the injection site, and numbed the left side of face and throat was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
No SOB, no chest pain - brief episode several minutes after IM injection given. Pt was responsive, observed for 15" then discharged with parents. Possible Dx vasovagal reaction by overseeing MD.
Patient presented with a red swollen area about 3" x 5" with a raised light area 2" x 3" in the center. Slightly warm to the touch. Patient had marked outer areas to measure movement. Advised to use ice pack and OTC pain medication.
bad headache; This is a spontaneous report received from a contactable consumer, the patient. A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6198) via an unspecified route of administration, administered in left arm on 04Mar2021 at 09:15 AM as 1st dose, single dose for COVID-19 immunization. The patient's medical history included enlarged prostate. The patient had ox codene allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 post vaccination. The patient did not suffer from COVID prior vaccination. The patient's concomitant medications included simvastatin, dutasteride, famotidine (PEPCID) and (tamsulosin hydrochloride) FLOWMAX (in two weeks after vaccination). On 05Mar2021 at 03:00 AM, the patient woke up with bad headache. The patient took two paracetamol (TYLENOL) and headache went away in about 1 hour 30 minutes. Event recovered on 05Mar2021.   No follow-up attempts are possible. No further information is expected.
Following morning had swelling & redness at the injection site. Saw Dr. the following day due to increased swelling and dark bruise at injection site w/ blisters surrounding. No fever, no swelling or blisters in any other location. Dr. prescribed "Clindamycin", antibiotic.
CHILLS, AWAKE FROM SLEEP CHOKING ON VOMIT. THEN HEADACHE, NAUSEA, SLIGHT DIZZINESS AND PAIN IN INNER CHEST THROUGH MID BACK THROUGHOUT THE DAY 10/07/14.
Vaccine was expired on 27-Mar-2022 and store in refrigerator on 3 day before the administration date (1-Apr-2022); 1 dose was administered past manufacturer expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose was administered past manufacturer expiration date) and PRODUCT STORAGE ERROR (Vaccine was expired on 27-Mar-2022 and store in refrigerator on 3 day before the administration date (1-Apr-2022)) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose was administered past manufacturer expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 27-Mar-2022 and store in refrigerator on 3 day before the administration date (1-Apr-2022)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 dose was administered past manufacturer expiration date) and PRODUCT STORAGE ERROR (Vaccine was expired on 27-Mar-2022 and store in refrigerator on 3 day before the administration date (1-Apr-2022)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medications was reported.   Reporter did not allow further contact
Deposit developed at elbow on back side night after vaccine was received, bruising and redness on arm but not at injection site.
OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. 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: 043A21B expiry: 21-JUN-2021) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAY-2021, the subject experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of out of specification product use was not reported. This report was non-serious.
Pt given Pneumococcal vaccine & developed 48 hours nausea - achiness.
Baby started with vomiting on evening of 4/14/22. This continued into 4/15/22 along with diarrhea. Mom noted red "bloody phlegm" in stool. Seen in ED on 4/15/22 and diagnosed with intussusception.
Shortly after the vaccine I started to feel very fatigued and my stomach was upset. By 6pm that night I had moderate fatigue, headache, muscle pain, nerve pain, tingling, cold feet and  chills.
Patient 2nd flu shot, became lethargic, felt warm, developed fever.  reduced PO - screaming, crying, heavy breathing.  Began to have emesis.  2 days later, still with fever, went to ER.  Mom concerned patient received incorrect dose of vaccine as documentation was incorrect.
Uncontrollable Shaking/Jerking,  pain and burning in neck, shoulders, back, and legs.   For a period of 2-3 hours unable to move legs, please I understand I do not mean I was too exhausted to move my legs, I was unable to MOVE my legs, this resolved after 2-3 hours.  The extreme pain and burning resolved by the end of August 2021.
Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On 25-SEP-2016, the patient was vaccinated with improperly stored VARIVAX (lot # M024681, expiration date 18-MAY-2018, 0.5 ml, once, subcutaneous). The vaccine was exposed to 28 Fahrenheit degree for 2 hours and 10 minutes. No adverse effects were reported. Data logger was involved. There was no prior excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Patient presenting with complaint of feeling blood rush from head to her toes. Vital signs at 10:41 BP: 122/62 HR:64 RR:12 02:96% Patient advised to elevate feet and lean seat back in the seat and wait 15 min and to notify of any changes. Patient left home with no other complaints.
Patient was at the Center on 11/6/2019 for an office visit and at the time she received a flu and PPSV vaccine.  The patient presented to the clinic on 11/8/2019 with a rash at both injections sites she claimed that started the day after receiving.  The rash had spread to her torso and upper back.  She was treated with Depo-Medrol 80mg.