chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pleurisy; sharp, severe pain in the rib area under the arm where I had had the injection; Pressure in my lungs have risen, but not high enough to be medicated; Impossible to take a deep breath; Could barely communicate; Daytime oxygen levels were in the 88-89% level during the day.; A Spontaneous report was received from a consumer who was also a 70 year old , female  patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who developed sharp, severe pain in the rib area under the arm "where I had had the injection"/ Musculoskeletal chest pain, impossible to take a deep breath/ Dyspnoea , could barely communicate/ Lack of spontaneous speech, pleurisy, daytime oxygen levels were in the 88-89% level during the day/ Oxygen saturation decreased, pressure in my lungs have risen, but not high enough to be medicated/ Pulmonary arterial pressure increased.   The patient's medical history included bronchitis and supplemental oxygen at night.  Concomitant product use was not provided by the reporter.     On 05 Feb 2021, approximately two hours before the onset of the events, the patient received her first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 05 Feb 2021, approximately two hours after receiving the vaccine, the patient experienced sharp, severe pain in the rib area under the arm "where I had had the injection"/ Musculoskeletal chest pain, impossible to take a deep breath/ Dyspnoea , could barely communicate/ Lack of spontaneous speech, pleurisy, daytime oxygen levels were in the 88-89% level during the day/ Oxygen saturation decreased two hours later. At the emergency room, blood tests, rib X-ray, and computerized tomography (CT) of the lungs were done.  The CR scan showed some changes, which the radiologist said could be asthma or chronic bronchitis.  The patient spent the next three weeks on supplemental oxygen during the day.  On 23 Feb 2021, an echocardiogram indicated that pressure in her lungs have risen, but not high enough to be medicated/ Pulmonary arterial pressure increased.  Treatment for the event was not reported.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event of developed sharp, severe pain in the rib area under the arm "where I had had the injection"/ Musculoskeletal chest pain, impossible to take a deep breath/ Dyspnoea , could barely communicate/ Lack of spontaneous speech, pleurisy, "pressure in my lungs have risen, but not high enough to be medicated"/ Pulmonary arterial pressure increased were not reported. The outcome of the event, daytime oxygen levels were in the 88-89% level during the day/ Oxygen saturation decreased, was considered recovered/resolved.; Reporter'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.; Sender's Comments:  MOD-2021-029767:Patient's friend
inj site warm, red, swollen & itchy;also swelling of face, body aches, joint aches;blood vessel in eye broken;
Patient received covid vaccine BUD. Vaccine expired on 7/7/2022 and was given to patient on 7/9/2022
Patient reports prolonged nose bleed on 05/01/21. Nose bleed resolved on its own and did not recur.
Patient was offered flu vaccine in today office visit, Pt accepted, filled out screening questionnaire. Flu vaccine was given by Medical assistant . When documenting vaccine, she noticed flu vaccine was already given on 11/02/21, Pt states she didn't remember it being given last month. Provider spoke w/ Pt over the phone regarding monitoring symptoms these next few days, Pt is to call us if she develops any  severe symptoms. Pt verbalized understanding.
24 year old otherwise healthy patient with numbness to bilateral legs w/ radiation up to thighs/buttocks w/ progression including arms up to shoulders and now including the face and tongue. Symptoms started on 31 Oct 2020. Numbness/tingling started in the R hand approx. on 31 Oct then the L hand the same day w/ subsequent involvement of the bilateral lower extremities. Physical exam in the ED on 04Nov notable for R eyelid pstosis, decreased patellar and Achilles reflexes but otherwise nml neuro exam as documented in record. Recent immunizations including JEV on 04 Sep 2020 and Anthrax, JEV, and Rabies on 07Aug20. He uderwent IVIG therapy for GBS. He has made significant recovery from dysmetria and ataxia. He also experienced postural tachycardia, most likely secondary to dysautonomia from GBS. Current HR in the normal range with ACEI and beta blockers. He is currently in physical therapy for follow up exercises for motor weakness.
Around 3 PM  on 3/2  arm was extremely sore and became worse  as time progressed.  By 6 PM developed aches, chills and low grade temperature.  Became lightheaded.  Could not sleep due to symptoms.  No appetite but drank herbal tea and water with added electrolytes.  That severity of symptoms lasted until 3/4 at 6 AM.  Still am having some  residual effects as one might have with the flu ? fatigue etc. Temperature is gone no more chills appetite still diminished.
Fatigue, arthritis flare evening after shot and worse the follow days (sciatica, back pain, knee pain and instability)
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # K026385, expiry date 15-DEC-2015, 0.5 ml, subcutaneously). No adverse effects were reported. Additional information has been requested.
administered dose 08Sep2022, expiration date of 07Aug2022; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) (batch number XQ39D, expiry date 7th August 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th September 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 8th September 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 8-Sept-2022 Reporter's comment: The pharmacist reported that a nurse came to her stating that the patient was administered a dose of Twinrix on the day of reporting, which had an expiration date of 7th August 2022. The reporter did not had any of the patient information, so she did not knew which dose number in the series this was, patient's age, or gender.   At the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Twinrix, which led to expired vaccine used.
Pfizer-BioNTech COVID-19 Vaccine EUA Chills roughly 12 hours after administration. Resolved by the next morning Headache began 15May21 resolved 16May21 Left Hip pain from 16May21-17May21 Pain in outer left thigh 19May21 - ongoing (no redness or swelling) Fatigue: 14May-15May21
Large local reaction 1.75 x 1.25 erythema and induration.
I contracted COVID 19 4/24/22 with symptoms of sore throat, and low-grade temp which lasted for 6 days. I have hoarseness in my voice lingering, but all other symptoms have resolved. I was prescribed and began taking Paxlovid 04/26/22.
Information has been received from a registered nurse concerning a 6 year old male who was vaccinated with a dose of varicella virus vaccine live. Subsequently the patient developed mild breakthrough varicella. It was unknown if medical attention was sought. The patient's outcome was not known. There was no product quality complaint involved. Additional information has been requested.
On the day of vaccine, after 6hours, Swelling and painful on left arm and Shot area temperature is higher than other body part. Got fever at night, last few hours , back to normal temperature in the morning. Today is the second day, Left arm is still pain and feel pain when move around or being touched.
I am just reporting that I experienced mild flu like symptoms the day after my 1st dose of the shingles vaccine. I got it at a pharmacy. I had a fairly sore arm with a red spot about 3 inches across at the injection site. I had mild chills and body ache like I was getting the flu. By Tues I am feeling ok, but still have a faded red spot around the site. I am fine and plan to get the second shot in a few months, but I just wanted to report this. I am an otherwise very healthy person and jog about 20 miles a week.
Got very sick; Thought she was going to die; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got very sick) and FEELING ABNORMAL (Thought she was going to die) in a 101-year-old female patient 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got very sick) and FEELING ABNORMAL (Thought she was going to die). At the time of the report, ILLNESS (Got very sick) and FEELING ABNORMAL (Thought she was going to die) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided by the reporter.  Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Non-Significant follow up was received.
Swollen eyes, swollen lips, weakness not able to walk or get out of bed. Arm was red like a beehive from shoulder down to elbow for a week. Temp. Blurred vision, deep cough, hard to breathe, swollen glands. Shots in one arm. They gave me same pneumonia shot as last year. BENADRYL and antihistamine.
Pt recvd 1st dose of HIB on 10APR92 & pt recvd prior doses of HIBTITER on 4DEC91 & 7FEB92; On 18JUL92 pt devel meningitis; pts exp was considered life-threatening; No further details were provided;
Information has been received from a physician concerning an 8 year old white male with a PCN allergy who on 02/02/1999 was vaccinated SC in the RA with a first dose of varicella virus vaccine live. There was no concomitant medication. On 08/02/2004, the pt developed a full blown case of chickenpox with more than 50 very red pustular lesions. It was not reported to be itchy. The pt was prescribed antibiotics including Duricef and Bactroban to treat the lesions. Follow up was scheduled for the next week. The physician believed that it was spurred by a daycare outbreak in the area. A product quality complaint was not involved. Follow up information was received from the physician who indicated that the pt developed a rash over the weekend of 07/30/2004. The pt was seen on 08/02/2004 with varicella and greater than 50 lesions. Some lesions were apparently becoming secondarily infected with surrounding erythema. Most lesions were pustular. The pt was treated with Duricef and Bactroban topically with supportive care. The pt was not febrile and there were no other symptoms of concern. It was noted that the pt was exposed at a child care center where at least five other cases were reported by the daycare and were all vaccinated per the care taker. No further information is exepected.
Fever, very sleepy, a lump or cyst in the same place as the vaccine that disappeared and then appeared on my neck and I still have it.
Left upper extremity (injection arm) dysfunction x ~50 hours. Unable to use left arm; unable to lift with no resistance.
Left upper arm redness, swelling, warmth, and pain and itchiness; spreading over past two days, since receiving influenza vaccine to the same site.
accidently given a menactra instead of the bexsero dose with no reported adverse event; Initial information received on 02-Aug-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 18 years old male patient who was accidently given a menactra instead of the bexsero dose with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included booster dose of tozinameran (pfizer biontech covid-19 vaccine) for Immunisation.  On 17-Jul-2023, the patient received 0.5 ml (dose 3) of suspect meningococcal A-C-Y-W135 (D CONJ) Vaccine, Solution for injection lot U7449AA via intramuscular route in the right deltoid for immunization (strength, expiry date: unknown) and suspect meningococcal vaccine B RFHBP/NADA/NHBA OMV not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site for prophylactic vaccination (strength, formulation, dose, batch number, expiry date: unknown), the patient was accidently given a menactra instead of the bexsero dose with no reported adverse event (wrong product administered)(latency same day).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (wrong product administered).  Outcome was Unknown for the event wrong product administered.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Mom described reddened area to right thigh, site of Prevnar, T 101.9. Right, mom declined treatment, home care triaged by Night care/ Intellicare Service
Feet are noticeably swollen. Veins always visible, not feet are slightly puffy and smooth.  Heart rate dropped from typical 60-62bpm to 50bpm.
Pt vaccinated with DTP/OPV/MMR/HIB developed fever of 106, febrile seizure, no other illness reported. MD states received too many vaccines at one time & caused adverse reaction. Possible viral seizure but not r/o possible reaction to vax.
Patient received flu vaccination around 11:00 AM on Thurs., Nov. 18, 2004. He developed a shaking fever by 5 PM. He saw his doctor the next day and was put on cipro. The fever persisted and he was admitted to hospital on Sunday. He had extensive cardiac w/up (s/p MI about 20 years ago)and treated for CHF. Both staph and strep were detected in blood cultures. Hospitalized for one week, including ICU. Medical Records received on 2/14/2005 states wheezing and CHF. Discharge Summary received on 2/7/2005 states urinary frequency, tracheobronchitis, renal failure, pleural effusion and infection bacterial.
Within 10 minutes of receiving the pneumovax 23 vaccine, the patient began experiencing what she described as heavy chest with heavy breathing, cloudy head, extreme pain in lower back and hip joints. She began to also have racing heart.
hives left arm 3 minutes after vaccine administration, lip swelling and tingling starting 10 minutes after
Pt receive 2 doses of Pfizer COVID-19 vaccine on 4/16/2021 & 5/11/2021. On 12/25/21 presented to hospital with C/O SOB for "a few days". Found to be COVID-19 positive.
Pt reported "fluish" in PM, arm sore then temp 104 degrees, body aches, headache. No appetite. Temp 102 on 10/20 upon arising. 101 PM. By 10/21 temp 101-99. Still achy. Poor appetite.
I had no reaction after the first dose. At 28 hours after the second dose, I developed a large red, vaguely itchy, patch about one inch below the injection site. I know this is delayed cutaneous hypersensitivity, only onset was not as much delayed as the norm. It is hot to the touch. I had been taking benedryl even prior to the injection and continue to do so. The red patch reached its peak at 48 hours and is now receding.
Patient began having dizziness and difficulty getting a full breath/yawning profusely, trouble talking within 5 to 10 minutes of vaccination. Administered 0.3mg epinephrine to patient about 20 minutes after vaccine. 911 was called and fire department responded.
Woke up in night with right side neck pain and nausea and felt bad. Over course of time the following symptoms occurred - front tooth numbness, drooling, strange tastes in mouth, watery eyes, blurred vision, unable to speak clearly, right sided facial flaccid.  Was diagnosed with Bells palsy.
received a dose from a vial that was kept in the refrigerator too long; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that was kept in the refrigerator too long) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that was kept in the refrigerator too long). In November 2021, EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that was kept in the refrigerator too long) had resolved.       No concomitant medication were reported.   No Treatment drug were reported.  Patient received her booster dose about one week after 26-Oct-2021 and was notified by the same vaccination site that she received a dose from a vial that was kept in the refrigerator too long.
chills; fever; nausea; pain in my arm was more sharp; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), NAUSEA (nausea), VACCINATION SITE PAIN (pain in my arm was more sharp), CHILLS (chills) and PYREXIA (fever) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 033B21A) for COVID-19 vaccination.     The patient's past medical history included Bleeding nose (Bloody nose after receiving the flu shot). Concurrent medical conditions included Drug allergy (Since childhood, cannot take aspirin due to thin blood).   On 14-Apr-2021 at 11:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021 at 11:40 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (headache). On 12-May-2021 at 7:00 PM, the patient experienced NAUSEA (nausea) and VACCINATION SITE PAIN (pain in my arm was more sharp). On 13-May-2021 at 4:00 AM, the patient experienced CHILLS (chills) and PYREXIA (fever). The patient was treated with IBUPROFEN (IBALGIN) for Adverse event, at a dose of 400 milligram. On 13-May-2021, CHILLS (chills) had resolved. On 13-May-2021 at 12:00 PM, VACCINATION SITE PAIN (pain in my arm was more sharp) had resolved. On 14-May-2021, NAUSEA (nausea) had resolved. On 14-May-2021 at 11:00 PM, PYREXIA (fever) had resolved. At the time of the report, HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2021, Body temperature: 100.5 (High) Fever.         The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable. No concomitant medications were reported.
Pain behind both ears for 12 Days. Rash on both ears (Pinna of the ear) for 12 Days.
Within 8 hours developed redness, tenderness, acute swelling of left arm-deltoid muscle. Radiate to neck and down arm. Radial pulse of 3+, sensation WNL.
Swelling of left arm for over a week after administration of HAVRIX, accompanied by a rash spreading down to the elbow. Region feels warm to the touch. Patient saw doctor and was told there was no cause for concern.
FEVER; ACHES; This spontaneous report received from a vaccine facility via a company representative 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, start therapy date were not reported 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 15-MAR-2021 09:45, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and aches was not reported. This report was non-serious.
Narrative: Patient with a history COPD, HTN, hyperlipidemia, diabetes, gout, and episode of syncope Sept 2020 (possible orthostatic hypotension). The day after COVID booster and influenza vaccine, patient was taken to an outside hospital by family at 6 am where he later died due to an brain aneurysm per report from the patient's son. The outside hospital did not think the brain aneurysm was related to vaccinations, per report from the patient's son.
A non-serious spontaneous report of one day after giving FLUMIST I think I got H1N1 and H1N1 with symptoms of became ill, very sick, high temperature of 103 F, cough and absolutely immobilized has been received from a health professional concerning a 56-year-old female, subsequent to FLUMIST. Neither the patient's past medical history nor the concomitant medications were reported. The patient did not receive FLUMIST. The patient whose was an nurse, administered a substantial number of seasonal and H1N1 FLUMIST in November 2009. About one day after giving FLUMIST, she thought she got H1N1. The patient was very sick and never tested for H1N1. The symptoms were high temperature of 103 F, cough and absolutely immobilized on the couch. The symptoms resolved by the next Monday morning. The outcome of both the events was resolved.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 4 (booster), single at the age of 58 years, in left arm 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 included: "obesity" (unspecified if ongoing); "MS" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs. The patient's 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 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive a week after completing  paxlovid; Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: On 08Oct2022, the patient received Paxlovid treatment for covid 19.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.