chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lot of heat coming out; Size of a golf ball area (not protruding); Really itchy; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Lot of heat coming out), VACCINATION SITE MASS (Size of a golf ball area (not protruding)), VACCINATION SITE PRURITUS (Really itchy) and VACCINATION SITE SWELLING (Swollen) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS, Glaucoma and Blood pressure high. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Lot of heat coming out), VACCINATION SITE MASS (Size of a golf ball area (not protruding)), VACCINATION SITE PRURITUS (Really itchy) and VACCINATION SITE SWELLING (Swollen). At the time of the report, VACCINATION SITE WARMTH (Lot of heat coming out), VACCINATION SITE MASS (Size of a golf ball area (not protruding)), VACCINATION SITE PRURITUS (Really itchy) and VACCINATION SITE SWELLING (Swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication also included medication for glaucoma NOS and for high blood pressure NOS. Treatment information mentioned ibuprofen and ice. Patient mentioned she has a tattoo at the site too.
Within 24 hours after administration, pt stated she had swelling up and down her left arm. She stated she felt a nodule on the arm where the immunization was administered. Pt stated that the reaction last approximately 2 to 3 weeks before resolving.
After getting the immunization in store, once patient arrived home a couple of hours later she started ti getting itching and a rash on the face.
Patient was anxious about shot.  After receiving vaccine approximately 15 minutes patient was walking and fainted.  Called 911 and was evaluated by EMS.  EMS state his blood sugar was low and was given a snack and stated blood pressure was coming down.  EMS released patient to parent.
Bronchitis; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (Bronchitis) in a male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BRONCHITIS (Bronchitis). At the time of the report, BRONCHITIS (Bronchitis) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported. This case was linked to MOD-2022-543451 (Patient Link).
left leg was paralyzed; muscle aches; vertigo; fell; This is a spontaneous report from a contactable other health care professional(patient). This 51-year-old female patient (not pregnant) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 19Jan2021 11:30 via an unknown route in left arm for Covid-19 immunization. Medical history included diabetic (diagnosed during hospitalization) and chronic pain. Concomitant drug was not provided. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at 29Dec2020 11:30 AM in left arm for Covid-19 immunization. Patient had no other vaccine in four weeks, no other medications in two weeks. Patient had no covid prior vaccination. Patient had no known allergies. Patient started to have muscle aches on Wednesday morning (20Jan2020 08:00) the day after second COVID shot. Patient felt worse on Thursday. Patient went about daily activities to prepare for 24 hr shift on Friday. went to bed at 8:00pm because she had to get up at 04:00am for her shift. She tried to get out of bed and when she stood up and tried to take a step, left leg didn't move and patient fell forward on face. Patient thought she might of had vertigo. Patient struggled to get to the kitchen where she called of if work to her boss. Her left leg was weak. On Saturday the same thing happened. On Sunday she did the same thing. This time when she fell, left leg was paralyzed. She tried for 6 hours to get it to move. She called the ambulance and was taken to Hospital. She was admitted for 3 days. She had multiple tests and had been off work since then.  Lab data included CT, MRI, and bloodwork. Treatment included IV fluids. Outcome of the events was resolving. Covid tested (Nasal Swab) post vaccination on 24Jan2021 was negative.  Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available and due to a plausible temporal relationship, a possible contribution of the suspect drug administration to the reported events 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  Ethics Committees and Investigators, as appropriate.
Pt stated they woke up, got out of bed then lost consciousness for approximately 30min.
Baby became limp and lethargic instantaneously. Face began to turn blue, eyes rolled back into head. No temperature, cold to touch. 10 mins later had more mild episode of same symptoms without turning blue. Temperature came about 30 mins after episodes in the ambulance on her way to the hospital.
when she takes any vaccine her arm is sore for a little bit; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 20May2021 as dose 2, single (Lot number: EW0175) at the age of 78 years for covid-19 immunisation. The patient's relevant medical history included: "pacemaker", start date: 2012 (ongoing); "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN taken for blood pressure abnormal, start date: 2012. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, lot ER8729), administration date: 15Apr2021, when the patient was 78-year-old, for COVID-19 immunization, reaction(s): "heart started racing", "She took a test and she caught the virus", "She took a test and she caught the virus"; Flu shot (Also had a Flu shot unknown date. Manufacturer unknown.), for Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "when she takes any vaccine her arm is sore for a little bit". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: arm soreness - when she takes any vaccine her arm is sore for a little bit and goes away. When queried what vaccines cause arm soreness caller states all booster shots, she takes she gets sore arm. Unable to clarify further. Sender's Comments: Linked Report(s): US-PFIZER INC-202300100075 same reporter/patient, different dose number/event;
Pt recv vax on unspecified day; 16 days post vax pt exp red/ raised bumps at vax site- rt leg, bump on lt groin leg area which blistered
chest pain with throat irritation 1 day after receiving vaccine. no anaphylaxis. symptoms resolved.
Initial information received on 05-Mar-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 42-years-old female patient who received a expired dose of vaccine ADACEL batch number: U5552AA, expiration date: 08-Feb-2019 via unknown route in unknown administration site on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccine was given on same time. It was an actual medication error due to expired vaccine used. A patient was given an expired dose of ADACEL vaccine. It was unknown whether patient experienced any adverse event following vaccination. 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 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. List of documents held by sender: none.
Vaccinated 9/29 after possible exposure to patient with zoster outbreak.  Called 10/1 with fever 103 degrees and muscle achiness.  10/3 admitted to Hospital 105 degrees temp with Nuchal Rigidity. Pt remains in Hospital as of 10/9/08.  Diagnosis unknown.  9/14/09 Hospital records received DOS 10/3/08 to 10/9/08. Assessment: Aseptic meningitis secondary to Lyme infection, headache, hepatitis. Patient presented with complaints of headache, fever, neck stiffness, shaking chills. Erythema, macular rash below neck and upper chest. Looks ill.  ICD-9 Codes: 088.81 Lyme disease, 320.7 Meningities in bacterial diseases classified elsewhere, 573.3 Hepatitis, V070 Need for Isolation, V12.09 Personal history of infectious and parasitic disease, V01.89 Contact with or exposure to communicable diseases, 272.4 Unspecified hyperlipidemia, 276.8 Hypopotassemia
Twelve hours after my second dose of the Shingrix vaccine I experienced extreme vomiting and diarrhea (simultaneous). I assumed that I had Norovirus, but as no one else in my family got sick and I had not been exposed to any known infected people, I wondered whether it was in response to the vaccine. The vomiting continued through the night and the diarrhea lasted about 48 hours. After my FIRST dose of the Shingrix vaccine, a couple of months earlier, I had experienced fatigue for about one day and a very sore arm that lasted a week, but no vomiting/diarrhea.
the caller is now getting pain at the injection site where it was very bad last night; pain in her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Single, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Single, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "the caller is now getting pain at the injection site where it was very bad last night"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in her arm". Therapeutic measures were taken as a result of vaccination site pain. Additional information: She was a consumer that received the adult formulation Pfizer BioNTech Covid-19 vaccine booster back in Nov2021. She was now getting pain at the injection site where it was very bad last night and she applied Biofreeze and it helped. She mentioned to them that the pain was where she got the booster that was going towards under her arm. She would like to know why this was happening and was it normal. She called about the Pfizer COVID-19 vaccine and reported that she took the shot in Nov2021, but did not remember the day. Now she was getting pain where the shot was. The pain was very bad last night. She put Biofreeze on it and it helped. She was concerned as to why this was happening. 75 year old female consumer states she has pain in her arm from the booster shot for the Pfizer COVID vaccine 3 months later and caller wanted to know if this has been reported.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Aug2020 as dose 1, single (Lot number: P220395-0012L), on 26Aug2020 as dose 2, single (Lot number: P220395-001) and on 08Oct2021 as dose 3 (booster), single (Lot number: P223937-0002L) at the age of 28 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing), notes: Known allergies: Latex. Concomitant medication(s) included: ARMODAFINIL; DESVENLAFAXINE; DAYQUIL AND NYQUIL SEVERE+ VICKS VAPOCOOL COLD AND FLU. Past drug history included: Bactrim, reaction(s): "Known allergies: bactrim". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Patient had received Other medication in 2weeks. Patient had received Paxlovid as Anti viral drug for the COVID 19 Treatment from 28May2022 to 01Jun2022. Symptoms resolved after course of Paxlovid and initial isolation period. Around day 10, a cough started. On day 14, the cough worsened and patient started to feel fatigue, congestion, and sore throat. Patient  took a home COVID test and it was positive. Patient found the CDC guidance for Paxlovid rebound, including this reporting link and guidance to isolate again.    No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
I had my vaccination on 09/16/2022. On 03/10/2023 I woke up with a very sore throat and I tested COVID-19 Negative. I woke up feverish that Saturday. On Sunday I tested COVID-19 Positive. I was prescribed a cough suppressant. I still presently have the cough on 03/21/2023
The patient received her vaccine at 2:03pm.  The patient complained of light headedness at2:10pm. Her blood pressure at this time was 112/72, pulse ox was 99% and pulse was 86. At 2:20pm, the patient complained of a headache, heavy eyes, and facial pressure.  Her pulse was 80 , pulse ox 97%, Blood pressure 106/66. She was given acetaminophen 650mg by mouth at this time. At 2:40pm she also complained of light sensitivity alongside of the headache and heavy eyes.  She rated her headache at 5 out of 10. Her blood pressure was 102/64, pulse 80, and pulse ox 99% At 3:08pm, she reported her headache was 5 out of 10, still light sensitive, and eyes felt heavy.  Her BP was 102/68, pulse 83, and pulse ox 94%. At 3:20pm, the patient stated she felt better with headache improving to 3/10, pulse ox at 99%, pulse 82, BP 110/80.  Patient's light headedness had resolved and she stated she was ready to leave to go home.  She did cancel the rest of her workday.
no symptoms; patient who received 3 doses of GARDASIL 9 in 2017 received an additional dose of GARDASIL 9 on 1/2/2019; This spontaneous report was received from a nurse and refers to a 19-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On unknown dates in 2017, the patient was vaccinated with 3 doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), intramuscularly (strength, dose, frequency, lot # and expiration date were not reported) for prophylaxis. On 02-JAN-2019, the patient was vaccinated with additional dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly, (lot # 1621929, expiration date 06-DEC-2021) (strength and dose was not reported) for prophylaxis. It was confirmed that the administration of the GARDASIL 9 was not the result of product confusion. No adverse effects were reported.
ached over body, equilibrium off, red eyes double vision, lasted 2 days  pain injection site left arm last almost one week
rash; itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) and PRURITUS (itchy) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011MZ0A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (rash) and PRURITUS (itchy). At the time of the report, RASH (rash) and PRURITUS (itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication given no treatment provided
Patient stated after the vaccine. The site where she got the vaccine was hot and red and warm to the touch. The redness was all over the site where she got the vaccine. The doctor seen her on the 4 and gave her some antibiotic thinking it could be due to celulitis.
Day 12 after vaccine booster (3rd dose) - I broke out into hives all over body. I did not have an immediate reaction to the vaccine. I have never had hives in my life. I am not sure if this is due to the vaccine or something else, but I can not think of any major diet/environmental changes. I do not have any allergies. Please help - this rash is scaring me.
No additional AE details available; Inbound call from nurse who reports the first dose of GARDASIL 9 was administered to a pregnant patient today 12JUL2023. No additional AE details available. No additional AE reported. No PQC.; This prospective spontaneous report was received from nurse, regarding a 25-year-old female pregnant patient. The patient's pertinent medical history, previous drug reactions or allergies were not reported, concomitant medications included acetylsalicylic acid (ASPIRIN).  Patient time of gestation or last menstrual period (LPM) were not provided. On 12-JUL-2023, the patient was vaccinated with  the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  injection, as prophylaxis (lot number W026977, which was determined to be valid, with an expiration date on 04-JAN-2025) (strength, dose, route and anatomical location of administration were not reported) (Maternal exposure during pregnancy).   No adverse additional adverse event was provided.   At the time of reporting, the outcome of patient's pregnancy was pending.
Slightly sore arm; This spontaneous case from the was received on 22-Jan-2021 from other non-health professional (consumer) via Agency (reference number: SEQW21-00272) and concerned a female patient of an unreported age.  The patient's concurrent conditions included allergy to polyethylene glycol. The patient's concomitant medications were not reported.   On an unknown date, in the past as reported, the patient was vaccinated with a Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose: 0.5 ml, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.   On an unspecified date, an unknown amount of time after receiving Fluad Quadrivalent, the patient experienced slightly sore arm.   On an unspecified date, the patient recovered from the event.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A patient of unknown age was administered Fluad Quadrivalent. On an unspecified date, an unknown amount of time after receiving Fluad Quadrivalent, the patient experienced slightly sore arm. Causal role of the suspect vaccine is assessed as possibly related.; Sender's Comments: A patient of unknown age was administered Fluad Quadrivalent. On an unspecified date, an unknown amount of time after receiving Fluad Quadrivalent, the patient experienced slightly sore arm. Causal role of the suspect vaccine is assessed as possibly related.
possibility of having a stroke; severe neurological symptoms; difficulty with her speech (can think of the word, but could not get it out); she had gait problems; Missed dose; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (possibility of having a stroke), NEUROLOGICAL SYMPTOM (severe neurological symptoms), SPEECH DISORDER (difficulty with her speech (can think of the word, but could not get it out)) and GAIT DISTURBANCE (she had gait problems) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE, MORPHINE SULFATE, AMITRIPTYLINE, METFORMIN, GABAPENTIN, LOSARTAN, CLOPIDOGREL, PANTOPRAZOLE, RISPERIDONE, DAILYVIT WOMEN 50+, INSULIN HUMAN INJECTION, ISOPHANE (NOVOLIN N) and INSULIN ASPART for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced CEREBROVASCULAR ACCIDENT (possibility of having a stroke) (seriousness criterion hospitalization), NEUROLOGICAL SYMPTOM (severe neurological symptoms) (seriousness criterion hospitalization), SPEECH DISORDER (difficulty with her speech (can think of the word, but could not get it out)) (seriousness criterion hospitalization) and GAIT DISTURBANCE (she had gait problems) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dose ). The patient was hospitalized on 21-Feb-2021 due to CEREBROVASCULAR ACCIDENT, GAIT DISTURBANCE, NEUROLOGICAL SYMPTOM and SPEECH DISORDER. On 10-Mar-2021, CEREBROVASCULAR ACCIDENT (possibility of having a stroke), NEUROLOGICAL SYMPTOM (severe neurological symptoms), SPEECH DISORDER (difficulty with her speech (can think of the word, but could not get it out)) and GAIT DISTURBANCE (she had gait problems) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed dose ) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Company comment:Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Further information has been requested.
After injection patient started turning pale, then complained she didn't feel well, then passed out. Pharmacist caught her before she fell and called her name. She opened her eyes and was disoriented. Told her where was, had her lie down, monitored for 20 minutes. Her color returned and she was picked up by her boyfriend.