chrisvoncsefalvay/vaers-outcomes huggingface dataset:
freezing; skin hurts; pounding heart; cant stand up; fever; achy,muscles hurt; vomiting; tired,dried out; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (freezing), SKIN IRRITATION (skin hurts), PALPITATIONS (pounding heart), MOBILITY DECREASED (cant stand up) and PYREXIA (fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced FEELING COLD (freezing), SKIN IRRITATION (skin hurts), PALPITATIONS (pounding heart), MOBILITY DECREASED (cant stand up), PYREXIA (fever), MYALGIA (achy,muscles hurt), VOMITING (vomiting) and FATIGUE (tired,dried out). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. On 18-May-2021, FEELING COLD (freezing), SKIN IRRITATION (skin hurts), PALPITATIONS (pounding heart), MOBILITY DECREASED (cant stand up), PYREXIA (fever), MYALGIA (achy,muscles hurt), VOMITING (vomiting) and FATIGUE (tired,dried out) had resolved.            No concomitant medication was given. No laboratory details was given. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-143272 (Patient Link).
Narrative: 75 y.o. male patient who received the Janssen COVID vaccine (Lot#1802070 exp 5/25/21) on 3/18/21. Patient's wife called the call center reporting that he had rapidly declined over the previous 24 hours. Wife reported the patient was very weak and had not eaten in ~4 days. Wife called 911. Patient was admitted to a hospital on 03/20 with Acute CVA. Per outside records patient passed night of 03/20/2021. PMH includes dementia, CKD S4, A fib, and hx of 3V CABG. Reaction classified as severe as death occurred following vaccination.
Axilary lymph pain and edema in vaccinated arm with pain throughout internal part of arm down to hand
A 70 year old man had received Tice BCG, 3 installations (as of 11/26/2002) of a planned series of 6, for treatment of Bladder cancer, from early November 2002 to mid-November 2002 and Coumadine since August 2002, for treatment of a TIA and 2 aortic blood clots.  In October 2002 he had a significant drop in his monthly INR level, following the first 2 instillations of Tice BCG (from 2.5 in October 2002 to 1.5 on 11/21/2002).  Following the decreased INR level, his Coumadine therapy dose had been increased from 10 mg three times a day to 5 mg/day x 3 days, then 7.5 mg/day (taken x 2 days, as of 11/25/2002).  His INR level subsequently improved to 2.2 on 11/26/2002.
covid-19; covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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), outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Tested Negative; (unspecified date) Positive, notes: COVID 19 Treatment; (27Jul2022) Positive, notes: then 3 days later tested positive for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had no known allergies. Treatment included anti viral drug PAXLOVID was taken from 20Jul2022 to 24Jul2022 for COVID 19 treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201025324 Same patient, different product and event;
Infant went into unresponsive state for approx. 15 seconds at 1:00pm on 1/13/2010.  He went into another episode at approx. 1:15pm.  He was taken to the emergency room.  His cheeks were bright red.  He went into 6 more episodes while in the emergency room.  Each episode was longer than the first. We were admitted to the hospital at approx. 11:00pm.  He had two more episodes on 1/14/2010.  We were discharged on 1/15/2010 after his episodes ceased.
Between 2-3 hrs after injection, almost all moisture was gone from both eyes & they remained extremely dry, requiring eyedrops multiple times daily. Currently on RX Prednisolone Acetate drops, Erythromycin ointment & otc Refresh Celluvisc eye gel drops.
Elevated heart rate. Fever. Body aches and pain at injection site. Chills, hot cold flashes. Weakness and fatigue
Within 5 minutes of injection developed extremely itchy mouth, tongue and throat. I had taken 2 Benadryl 2 hrs prior to vaccine, bc had similar symptoms with my 2 vaccines earlier in the year.  (per my Doctor's order) I stayed 40 minutes at the site to be monitored. Also broke out in hot flashes about 25 minutes after the vaccine, but that subsided quickly.  Also, itchy hands (palms and wrist left and right) but that disappeared quickly.  Oral symptoms lasted about 2 hrs.
PT RECEIVED THE COVID -19 VACCINE,WHILE SHE WAITING FOR HER 15 MINUTES AS MENDATED ,SHE BEGAN HAVING ARM PAIN/TINGELING. A FEW MINUTES LATER SHE STARTED GETTING CHEST PAIN.WE CALLED 911. AND THEY ARRIVED IN 10 MINUTES. SHE HAD HER CAREGIVER NEXT TO HER.SHE WAS THEN TAKEN TO THE HOSPITAL,WE CALLED TO CHECK ON HER LATER AND CAREGIVER STATED SHE WAS DISCHARGED FROM HOSPITAL  AND THAT THIS IS BEHAVIORAL ISSUE, NO CARDIAC ISSUE AS PER CAREGIVER.
PARENT NOTICED AREA OF REDNESS AND SWELLING DURING BATH TIME. AREA IS RED, WARM TO TOUCH ABOUT THE SIZE OF A BASEBALL.
MMR administered on 01/17/2002. Symptoms began in the evening of 01/21/2002. Rash at hair line then over course of 7 days spread to entire body. Came as wright red pin-point rash and then fade. Very itchy, runny nose, cough, eyes hurt, photophobia, sore and dry throat, severe aching all over body, right sweats and chills. Treating self with Tylenol and Benedryl with temporary relief.
Vaccine was expired, past 10 weeks in the fridge, at the time of administration.  Expiration date was 3/30/22.  Patient is being called to advice per regulatory authority guidelines to be re-vaccinated
heat; redness; Swelling of vaccine site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (heat), ERYTHEMA (redness) and VACCINATION SITE SWELLING (Swelling of vaccine site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (heat), ERYTHEMA (redness) and VACCINATION SITE SWELLING (Swelling of vaccine site). At the time of the report, VACCINATION SITE WARMTH (heat), ERYTHEMA (redness) and VACCINATION SITE SWELLING (Swelling of vaccine site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication given. No treatment information provided.; Reporter's Comments: N/A; Sender's Comments: N/A
Patient developed right facial paralysis and no other symptoms on 4/4/21, pt. was given an injection of Solumedrol 125 mg IM. Patient was seen in clinic on 4/5/21 and  diagnosed with Bell's Palsy and treated with high dose of prednisone 60 mg with a 13 day taper. Patient was seen again on 4/13/21 with a slight improvement of symptoms.  High dose steroids was extended for another 13 day taper. Patient was seen again on 4/29/21, with symptoms about the same as last appointment.  Patient will be given some ibuprofen, no real benefit for more steroids at this time.  Patient will continue to have follow ups.  It has been less than a month since first symptoms were reported, and may take up to 6 months for symptoms to resolve.
vial underwent a temperature excursion; No adverse event; patient received vaccine from vial that underwent a temperature excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient received vaccine from vial that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (vial underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 50-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient received vaccine from vial that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vial underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient received vaccine from vial that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (vial underwent a temperature excursion) 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 assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (patient received vaccine from vial that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (vial underwent a temperature excursion).    Concomitant product use was not provided by the reporter.  The pharmacist reported that, temperature excursion occurred several days ago in the freezer. Multiple patients received vaccine from vaccine that underwent a temperature excursion in the freezer, and they just found out about the excursion in an audit. No adverse event reported for the patient.   Treatment information was not provided.
Fever,chills for 2 days and body aches on third day patient advice to go urgent care but declined.
Caller wanted to file lawsuit against Pfizer for getting covid but had received the covid vaccine; Caller wanted to file lawsuit against Pfizer for getting covid but had received the covid vaccine; This is a spontaneous report from a contactable consumer (patient) from a Pfizer Sponsored Program COVAX US Support. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient got COVID. It was reported that the patient wanted to file lawsuit against Pfizer for getting COVID but had received the COVID vaccine. The patient underwent lab tests and procedures which included COVID-19 test: positive on an unspecified date. Outcome of the event was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Excessive sweating and feeling feverish several hours post injection. For the past 2 day post injection: 1st full day: excessive sweating, feeling feverish, wide spread body aches/pain. Fatigue. Nasal drip. Headaches/migraine  2nd day (today): minor/full aches, feverish and sweaty. Nasal drip.
a 17 years old male patient received dose of Flublok Quadrivalent/ No AE; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case is linked to cases 2019SA291128 and 2019SA291168 (same reporter).  This case involves a 17 years old male patient who received a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1910, expiry date: 26-MAY-2020 via intramuscular route in the left arm on 14-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE).  It was an actual medication error due to inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.
Sore arm.  Extreme fatigue.  Could not stay awake for a day and a half.  Nausea. Extreme soreness in joints and muscles.  Unable to eat or drink.  Headache.  Completely "knocked out" feeling.
Pt. stated he felt dizzy and had a headache right after vaccine was administered. Pt. laid down, was given water and waited 20 min. in office.
pt recvd vax 2APR93 & 4APR93 pt exp burning & itching all over, flushing, a lack of energy, loss of appetite, noc sweats w/salt & medicine taste & lack of balance; presented to ER & was treated w/DPH & Atarax;
Arm at injection site swelled and became red and itchy. Patient saw doctor and he determined it was an allergic reaction to vaccine. 5 days in durations.
Swelling shoulder/elbow, nausea, dizziness, "jaundice", red and warm to touch.  Patient said she took Benadryl.  Saw patient today and she said she is feeling much better.
Patient received a 5-11 Pediatric vaccine instead of 12+.  Patient turned 12  but got the vaccine at 02/08/2010. No adverse reaction noted.
Vision changes (things became "pixelated"), Cough (slight bronchospasm), arm numbness/decreased strength in administration arm.
I could not turn my head/she couldn't turn her head or move her arm for over a week.; severe aches in my left arm, shoulder, and neck; severe aches in my left arm, shoulder, and neck; severe aches in my left arm, shoulder, and neck; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (I could not turn my head/she couldn't turn her head or move her arm for over a week.), NECK PAIN (severe aches in my left arm, shoulder, and neck), PAIN IN EXTREMITY (severe aches in my left arm, shoulder, and neck) and ARTHRALGIA (severe aches in my left arm, shoulder, and neck) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient never had COVID positive test or diagnosis. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Adhesive tape allergy, Drug allergy, Congestive heart failure (Started 10 years ago and recent change in status was worsening.), Drug allergy and Disability.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2022, the patient experienced MOBILITY DECREASED (I could not turn my head/she couldn't turn her head or move her arm for over a week.), NECK PAIN (severe aches in my left arm, shoulder, and neck), PAIN IN EXTREMITY (severe aches in my left arm, shoulder, and neck) and ARTHRALGIA (severe aches in my left arm, shoulder, and neck). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CELECOXIB (CELEBREX) at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (I could not turn my head/she couldn't turn her head or move her arm for over a week.), NECK PAIN (severe aches in my left arm, shoulder, and neck), PAIN IN EXTREMITY (severe aches in my left arm, shoulder, and neck) and ARTHRALGIA (severe aches in my left arm, shoulder, and neck) was resolving.            No concomitant medications were provided by the reporter. It was mentioned that for all the reported AE s the patient did not cause to seek medical care and the patient had similar reactions after the 2nd dose of Moderna. However, AEs were not as bad as the 3rd dose and did not last for a week. Outcome for all the events were improved with residual effects.   This case was linked to MOD-2022-566790 (Patient Link).
got the vaccine, still got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got the Shingles vaccine and still got shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Injection site got very swollen, itchy, warm to the touch; A rash spreading almost to her elbow; Injection site got very swollen, itchy, warm to the touch, hard and red; The injection site got very itchy; Injection site got very swollen; injection site got very swollen, itchy, warm to the touch, hard and red; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE WARMTH (Injection site got very swollen, itchy, warm to the touch), RASH (A rash spreading almost to her elbow), VACCINATION SITE INDURATION (Injection site got very swollen, itchy, warm to the touch, hard and red), VACCINATION SITE PRURITUS (The injection site got very itchy) and VACCINATION SITE SWELLING (Injection site got very swollen) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced VACCINATION SITE WARMTH (Injection site got very swollen, itchy, warm to the touch), RASH (A rash spreading almost to her elbow), VACCINATION SITE INDURATION (Injection site got very swollen, itchy, warm to the touch, hard and red), VACCINATION SITE PRURITUS (The injection site got very itchy), VACCINATION SITE SWELLING (Injection site got very swollen) and VACCINATION SITE ERYTHEMA (injection site got very swollen, itchy, warm to the touch, hard and red). At the time of the report, VACCINATION SITE WARMTH (Injection site got very swollen, itchy, warm to the touch), RASH (A rash spreading almost to her elbow), VACCINATION SITE INDURATION (Injection site got very swollen, itchy, warm to the touch, hard and red), VACCINATION SITE PRURITUS (The injection site got very itchy), VACCINATION SITE SWELLING (Injection site got very swollen) and VACCINATION SITE ERYTHEMA (injection site got very swollen, itchy, warm to the touch, hard and red) had not resolved.        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.   No concomitant medication were reported.   No treatment medication was reported.
Patient received a vaccine too high up on the arm causing pain as the medication entered and lingering discomfort and immobility.
SHORTNESS OF BREATH, SWOLLEN AREA TO SITE, HOT, ITCHY, RED, TIGHTNESS OF CHEST, TIRED.
A patient was administered Flublok vaccine inadvertently, no AE; Initial information was received on 03-Oct-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case is linked to case 2020SA273662 (same reporter).  This case involves a 16 year old male patient who was administered INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] inadvertently (product administered to patient of inappropriate age)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient received no other vaccines.   On 03-Oct-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot UJ463AA, expiry date: 19-Mar-2021, Strength: standard) once via intramuscular route in the left arm for prophylactic vaccination.  It was a case of an actual medication error due to product administered to patient of inappropriate age (latency same day).  The pharmacist stated that they were having an event and two patients of age (11 and 16) were inadvertently given the Flublok immunization  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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.
Patient stated he felt "lousy with chills" the day of the shot and this continued into the next day.  He was feeling better by the next day.  3 days after the vaccine he states he developed body aches and a sore throat, that has not improved.
Approx 24 hours after 2 month vaccine, our daughter went from having normal yellow seedy stool to very mucousy stool with streaks of blood. The change is present in ALL diapers and is drastic. Daughter appears to have abdominal pain and is fussy. Three weeks later the symptoms persist and she was also diagnosed with small bowel intussusception. Mother has eliminated dairy & soy from diet to confirm that they are not at issue.