chrisvoncsefalvay/vaers-outcomes huggingface dataset:
really severe inflammation in her lower body /  The inflammation at the base of her spine hurt so bad that she could not do her job and impacted her life; her back hurt / The inflammation at the base of her spine hurt so bad that she could not do her job and impacted her life; it affected her joints and her knee were severely inflamed; could not walk down the stairs; The inflammation at the base of her spine hurt so bad that she could not do her job and impacted her life; spine hurt; she could not sit down or bend over; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (really severe inflammation in her lower body /  The inflammation at the base of her spine hurt so bad that she could not do her job and impacted her life), BACK PAIN (her back hurt / The inflammation at the base of her spine hurt so bad that she could not do her job and impacted her life), ARTHRITIS (it affected her joints and her knee were severely inflamed), GAIT DISTURBANCE (could not walk down the stairs) and MOBILITY DECREASED (she could not sit down or bend over) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced MOBILITY DECREASED (she could not sit down or bend over). On an unknown date, the patient experienced INFLAMMATION (really severe inflammation in her lower body /  The inflammation at the base of her spine hurt so bad that she could not do her job and impacted her life), BACK PAIN (her back hurt / The inflammation at the base of her spine hurt so bad that she could not do her job and impacted her life), ARTHRITIS (it affected her joints and her knee were severely inflamed), GAIT DISTURBANCE (could not walk down the stairs), GENERAL PHYSICAL HEALTH DETERIORATION (The inflammation at the base of her spine hurt so bad that she could not do her job and impacted her life) and SPINAL PAIN (spine hurt). In May 2021, MOBILITY DECREASED (she could not sit down or bend over) had resolved. At the time of the report, INFLAMMATION (really severe inflammation in her lower body /  The inflammation at the base of her spine hurt so bad that she could not do her job and impacted her life), BACK PAIN (her back hurt / The inflammation at the base of her spine hurt so bad that she could not do her job and impacted her life), ARTHRITIS (it affected her joints and her knee were severely inflamed), GAIT DISTURBANCE (could not walk down the stairs), GENERAL PHYSICAL HEALTH DETERIORATION (The inflammation at the base of her spine hurt so bad that she could not do her job and impacted her life) and SPINAL PAIN (spine hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Sore thigh muscles to the point of making walking difficult.  Symptoms started after a walk, typical in difficulty to other walks done in previous weeks.  At first soreness seemed the normal soreness after exercise, but then increased to an atypical level of pain, and also has lasted longer than post-exercise pain ever has for this individual.
Works in a medical clinic as an RN; Within hours after vaccine started getting arm pain, sweating; started aching and started urinating blood; For the next 2 days I stayed in bed and had a fever, chills and lower back pain where my kidneys are; Also started to have a ringing in my ears; After first day in bed I started having severe joint pain, it got progressively worse with time; I couldn't close my hand all the way, not able to hold onto anything; The joint pain slowly got a little better; Returned to work, though ringing in my ears never subsided; The next month I got a really heavy period for 2 weeks; no previous vx reaction.
Ipol was administered to 3 patients after excursion with no reported adverse event; on 11-AUG-2022 with the highest temp. being 47.5 degrees F for 10 minutes due to unknown reason but possibly due to the door being opened for too long with no reported adverse event; Initial information received on 13-Sep-2022 regarding an unsolicited valid non-serious case received from health professional. number: 01276952  This case involves an unknown age/gender patient who experienced ipol was administered to 3 patients after excursion with no reported adverse event and on 11-aug-2022 with the highest temp. being 47.5 degrees f for 10 minutes due to unknown reason but possibly due to the door being opened for too long with no reported adverse event while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, Ipol was administered to 3 patients after excursion with no reported adverse event (lot Z1A024M, expiry date: 17-Feb-2024) at unknown dose via unknown route in unknown administration site for immunization after excursion with no reported adverse event (poor quality product administered) (unknown latency).  It was reported that on 11-aug-2022 with the highest temp. being 47.5 degrees f for 10 minutes due to unknown reason but possibly due to the door being opened for too long with no reported adverse event (product storage error) (latency same day) following the administration of IPV (VERO).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for both events.  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.
Case number PHEH2015US017580, is an initial spontaneous report from a pharmacist received on 04 SEP 2015. This report refers to an 85-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient received expired FLUVIRIN 2014/2015 (batch number: 1411001) intramuscularly on 03 SEP 2015. No adverse event was reported.
Administration of vaccines after temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included DTPa-IPV (Kinrix) for prophylaxis, HBV (Engerix B) for prophylaxis and Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patients received Infanrix, Kinrix, Engerix B and Bexsero. On an unknown date, an unknown time after receiving Infanrix, Kinrix, Engerix B and Bexsero, the patients experienced incorrect storage of drug (Verbatim: Administration of vaccines after temperature excursion). The outcome of the incorrect storage of drug 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: 7-Mar-2023 The health care professional reported that there were multiple patients that might had received those vaccines after being exposed to below 32 Fahrenheit.  The reporter said that she spoke to someone that would send out a packet to her and she could gather patient details and mail information back. The reporter did not see a documentation trail and attempted to gather adverse event details and reporter declined.  No additional information provided. The reporter did not consent to follow-up. The patient received  Infanrix, Kinirx, Engerix-Band Bexsero below temperature excursion which led to incorrect storage of drug.
fever, bodyache, no energy, light headed, headache-severe.  Was sick for a week with these symptoms, woke up soak n wet
OUT OF SPECIFICATION PRODUCT USE; INCORRECT PRODUCT STORAGE (FIRST INCIDENCE- MAX 56.1 F, MIN 48.2 F, SECOND INCIDENCE MAX 35.2 F MIN 30.1 F); This spontaneous report received from a pharmacist concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, expiry: 07-MAR-2022) dose was not reported, administered on 18-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-OCT-2021, the patient experienced out of specification product use, and incorrect product storage (first incidence- max 56.1 f, min 48.2 f, second incidence max 35.2 f min 30.1 f). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the out of specification product use and incorrect product storage (first incidence- max 56.1 f, min 48.2 f, second incidence max 35.2 f min 30.1 f) was not reported. This report was non-serious.
pt fell at home, Left hip fracture; admitted to Hosptial and was dx with positive COVID test and UTI; dc'd to SNF; readmitted to hospital with aspiration pneumonia and A Fib; treated with  ABX; transitioned to palliative DNR, comfort care; do not re-hospitalize; 100% bed bound; pt dc'd again to Center for Rehab where he passed away
3/10 chest pain, sob, tachycardia   Improved 2/10 chest pain, ambulated out of clinic, denied admission to ED
Red raised welt, hot, purple at injection site, doubled in diameter within 24 hours, high fever, spike at 103.9, pain in arm through elbow and swelling of hand and fingers. Rapid heartbeat (156 bpm).  Administered Augmentin, required subsequent ER visit when temp spiked to 105.4.
This spontaneous report as received from a nurse refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On an unspecified date in June 2014, a dose of (Oka/Merck) VARIVAX 0.5 ml injection, subcutaneously (lot # and expiry date unspecified), that underwent a temperature excursion, was administered to a patient. No concomitant medications were reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
FEVERISH; HOT FLASHES; MUSCLE ACHES; MILD HEADACHE; SORE ARM. TOOK ADVIL 600MG 2X DAILY
No issues at all immediately after shot and for about two weeks after. Starting about 2 weeks after shot arm near injection site sore/achey. Has continued to be sore for past week.
arm sore; Arm red; arm swollen; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: arm sore), erythema of extremities (Verbatim: Arm red) and swelling arm (Verbatim: arm swollen). The outcome of the pain in arm, erythema of extremities and swelling arm were recovered/resolved (duration 4 days).   It was unknown if the reporter considered the pain in arm, erythema of extremities and swelling arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm, erythema of extremities and swelling arm to be related to Shingles vaccine.   Additional Information: GSK receipt date: 31-Mar-2023 The case was received from the patient via interactive digital media. The patient stated that first shot made him or her arm sore, red and swollen for about 4 days. The patient had the second shot and had zero side effects. The patient reported that he or she saw a girl (about 19 years at the time) went through shingles and a few days of a sore arm was a small price to pay to not go through what she did. The follow-up could not be possible as no contact details were available.
Within a couple of hours to present day, Pt reports started having auditory hallucinations (hearing voices all the time) and progressed to some visual hallucinations, as well as, confusion, paranoia, and insomnia since vaccination.
Patient had onset of malaise then tired, aches, headaches. On 5/31/10 she noted a small red splotch on left arm at injection site and red area on back.
Volunteer, RN, administered J&J vaccine to 14 yr old in error.  J&J not approved for anyone under 18 yr old.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (mild case of shingles 10 years ago). Previously administered products included ZOSTAVAX (anti-viral medication). On 29th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, influenza-like symptoms and erythema of extremities. On an unknown date, the outcome of the injection site pain, influenza-like symptoms and erythema of extremities were recovered/resolved. It was unknown if the reporter considered the injection site pain, influenza-like symptoms and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller reported that she experienced left arm soreness at the injection site for the day and flu like symptoms for 4 days and then resolved. The patient also experienced redness of arm for the day. The patient had denied permission to contact their physician.
only received first dose on 6-OCT-2020; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 6th October 2020 from batch number GM2Y4 with expiry date 10th May 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 24-Mar-2022 Reporter's comment: The pharmacy technician reported that, the patient only received their first dose of Shingrix. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Pt received H1N1 vaccination at 08:30.  No previous influenza vaccinations before.  Nurse observed pt. for 15 min after injection.  No s/s of anaphylaxis.  Pt. in constant contact with nurse.  Around 09:28 pt. states "Lips are a little swollen" pt. assessed no s/s of SOB, wheezing, itching, hives.  Moderate swelling of lower lip.  Pt. given 25 mg tab BENADRYL pt refused 50 mg.  Instructed to take 2nd tablet in 4 hrs.  Seek medical attention if symptoms persist.  Pt. refused other medical attention.
Diarrhea, chills,fever, total body aches, sensitive to light, sinus headache, extreme soreness around injection site
Pt called with symptoms of redness, dry and hot to touch on arm. Told to ice it, took TYLENOL & BENADRYL. Not improved so seen by Dr and prescribed PREDNISONE.
*ADMINISTRATION ERROR*  48 Y/O FEMALE PATIENT RECEIVED SECOND BOOSTER DOSE (PFIZER) BEFORE 50 YEARS OF AGE, RECOMMENDED BY CDC.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date in 2014, the patient was vaccinated with a dose of ZOSTAVAX, (dose, route of administration, anatomical location, lot # and expiration date were not reported) for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster (onset date was not provided). On or about 17-OCT-2017, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter determined the events to be related to the ZOSTAVAX.
Fever 103; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 103) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02UM20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced PYREXIA (Fever 103). At the time of the report, PYREXIA (Fever 103) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Feb-2021, Body temperature: 103 (Inconclusive) fever 103.         No concomitant medications were provided.  Action taken with mRNA-1273 in response to the events was not applicable.  Treatment medications were not provided.
No adverse effects were reported; Incorrect product storage; This spontaneous report was received from a medical assistant concerning a female patient of an unknown age. Information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medication was not reported.   On 18-MAY-2019, the patient was vaccinated with an improperly stored (product storage error) dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) batch # R012001, expiration date 06-NOV-2020, (strength, dose, frequency, route of administration and anatomical location, were not reported) for prophylaxis. No adverse effect were reported.   The vaccine was stored at temperature above of 47° fahrenheit (F) (48.7 F) for the time frame of 1 hour and 38 minutes. No previous temperature excursion was reported.  The call was because of data logger.; Sender's Comments:  US-009507513-1905USA011967: US-009507513-1905USA013165:
Soon after the shot I had swelling of my lips. I took an ALLEGRA and it subsided. The next morning I was dizzy upon waking. It got better and I went to lunch. At lunch I started to get severe vertigo and was also pale and short of breath. Went home and lay down and it subsided. The next day I felt ok and went to an evening meeting. The severe vertigo returned and lasted for eleven hours. I went to the Emergency Department at Hospital. They diagnosed me with vertigo. My ENT performed a series of tests and said it was Vestibular Neuritis. He believed that it could have been a result of the SHINGRIX vaccine. I am taking PT to help restore by balance.
Additional information received on 1/6/03 for a physician provided a revised diagnosis, additional test results, and treatment medication. A physician reported that 4 year old male with a history of asplenia and Wiskott-Aldrich syndrome received his first dose of Prevnar on 9/21/00 at 23 months of age. On 9/23/02, he presented to the emergency room with a headache, leg ache, and a fever of 105 degrees F. on 9/24/02, he was admitted to the hospital with a diagnosis of pneumococcal sepsis, which was confirmed by a blood culture taken on 9/23/02. The blood culture was positive for Streptococcus pneumoniae serotype 9V. An IgG, IgM, and IgA were all normal. A complete blood count revealed increased bands. He was treated with vancomycin. He recovered.
My left eyelid is bleeding without any known abrasion and my left arm is bleeding very easily.  Merely touching my skin seems to be peeling it off.
Fever, vomiting, rash,  hepatitis with direct hyperbilirubinemia, acute kidney injury (resolving) Amoxicillin for strep throat,  IVIG for possible Kawasaki disease,
same pain after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (same pain after receiving the vaccine) in a patient of an unknown age and gender 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 PAIN (same pain after receiving the vaccine). At the time of the report, PAIN (same pain after receiving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment medications were not reported.
After sixth week of vaccine I was feeling sharp pain on the right side, went away in a few days. A few days after that I had pain on the left side. I went to ER and they found cyst so big that it was decaying inside. That twisted my ovary because it was so big. They removed ovary. Then September I went again for pain on the right and they found a benign tumor. It was so big that also twisted Ovary. They remove the ovary for that one too. Still feeling pain on my right side.
developed as a result of Lyme's disease; it exacerbated her fibromyalgia; experienced a wide range inflammatory response in all joints; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2022US253025.  A female patient received BNT162b2 (BNT162B2), in Jan2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lyme's disease" (unspecified if ongoing), notes: Caller said it exacerbated her fibromyalgia, which developed as a result of Lyme's disease. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: LYME DISEASE (medically significant) with onset 2022, outcome "unknown", described as "developed as a result of Lyme's disease"; ARTHRITIS (non-serious) with onset 2022, outcome "unknown", described as "experienced a wide range inflammatory response in all joints"; FIBROMYALGIA (non-serious) with onset 2022, outcome "unknown", described as "it exacerbated her fibromyalgia".  Clinical Course: Reported as, Reporter received the Pfizer COVID booster in Jan2022 and experienced a wide range inflammatory response in all joints. reporter said it exacerbated her fibromyalgia, which developed as a result of Lyme's disease she contracted several years ago. Reporter mentioned spouse also received Pfizer COVID booster at the same time and experienced same side effects.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201399995 same reporter/drug/event, different patients;
This lot expired in the fridge on 1/17/2022, it was accidentally left in the fridge after the expiration date and was given to this patient