chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 vaccination.     Patients pre-existing conditions and allergy are unknown.     On 26-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported  No Treatment medication was reported. HCP reports on Apr-26-2022 3 patients received expired vaccine. Administrations included 2 second booster and 1 first booster of Moderna covid-19 vaccine.HCP reports no side effects regarding the individuals. patients pre-existing conditions and allergy are unknown. Patient administer 1st booster dose.   This case was linked to MOD-2022-553198 (Patient Link).
Patient reports shortness of breath since receiving vaccine. Has a hx of asthma and feels symptoms flared once receiving the vaccines when previously not having to use her inhaler for 2 years.
Information has been received from a nurse referring to an unspecified number of unspecified patients. Nurse reported on unspecified dates since 24-DEC-2014, the patients were administered an unspecified number of improperly stored doses of M-M-R II (dose, route and lot # not reported). No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
A literature report described a man devel rapidly ascending paralysis 3wk p/infant recv orimune;the man devel flaccid quadriplegia & resp failure requiring mechanical ventilation;LP produced CSF w/531 WBC & 126 RBC;cult positive for polio
This spontaneous case was reported by a consumer and describes the occurrence of THIRST (thirst), PALPITATIONS (severe heart pounding which continues for hours during the nigh), MALAISE (felt sick), MIGRAINE (migraine/had a bad migraine with very strong) and HEADACHE (I experience severe headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053C21A and 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Migraine since 09-Jan-1987 and Palpitations (Heart palpatations) since 01-Jan-2000.On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THIRST (thirst), PALPITATIONS (severe heart pounding which continues for hours during the nigh), MALAISE (felt sick), MIGRAINE (migraine/had a bad migraine with very strong), HEADACHE (I experience severe headache) and PYREXIA (low grade fever). At the time of the report, THIRST (thirst), PALPITATIONS (severe heart pounding which continues for hours during the nigh), MALAISE (felt sick), MIGRAINE (migraine/had a bad migraine with very strong), HEADACHE (I experience severe headache) and PYREXIA (low grade fever) had resolved.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: low (Low) low grade fever. No Concomitant medications were providedNo treatment medications were provided.This case was linked to MOD-2021-386718 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Follow up information received on  contains Significant information; patient demographics added, patient medical history added, vaccination dose information added, events added.
Tired, Irritable, Clingy, Fever, Shivers, teeth chattering, and lips turned blue in warm bath, Breathing speeds up and slows down.
This spontaneous report as received from a registered nurse refers to a 18 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 26-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M020102, expiry date: 08-MAR-2019, for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706.
Severe nausea lasting more than two weeks.  Severe migrane headaches and vision disturbances. Dizziness.  All of these have lasted more than two weeks and are currently ongoing.
Immediately the injection site began to puff up and swell. Patient reported back to the pharmacy 9/12/16 with a localized red rash around the injection site about the size of a baseball. The area was warm to the touch. Local soreness that has gone away.
patient received pre-exposure vaccine last Sunday, they ordered the product and it hasn't come yet, no AE; Initial information received on 02-Dec-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 21 years old female patient who missed her dose of RABIES (HDC) VACCINE [IMOVAX RABIES] since they ordered the product and it hasn't come yet (missed dose).   Medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapies were given.  On 24-Nov-2019, the patient received a dose of 1 ml ofRABIES (HDC) VACCINE (lot number P1E522M, exp date: Oct 30, 2020, via intramuscular route in the left deltoid) as pre-exposure vaccine.  It was an actual medication error due to missed dose (product was ordered but did not come yet).  At the time of reporting, the patient had no adverse event.  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.
Case number PHEH2015US026855, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 38-year-old male patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) into left deltoid on 12 Oct 2015 which was stored out of recommended temperature range (temperature excursion at 34 degrees). The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and  when she arrived the next day and the temperature was fine. It was a new refrigerator and there were not problems since the temperature excursion. No adverse event reported following this medication errors (incorrect storage of drug). Follow up information received via nurse on 26 Jan 2016: Reporter's comment updated.
Awoke 6/10 AM with swelling and pain at dT site left deltoid; better today with improved shoulder ROM; initial pain at site 6/2 when shot given but no symptoms thereafter until 6/10 AM; 15 x 7cm red, warm patch left deltoid with palpable spasm. Improving.
Pt given DTaP to Left deltoid. Red, slightly swollen after 15 minutes. Check came next day 02/22/2005. Left arm very red, swollen and hot to touch.
01/09/2020 7AM: sore arm, headache, queasy stomach & lightheadedness noted. Approx. 10 mins later I fainted spent the rest of day in bed, sleeping 50% of time & reading 50% of time Pupils equal & reactive
experienced excursion at temperature of 48 degrees F lasting for 96 hours due to the refrigerator being left openwith no reported adverse event; Initial information received on 01-Mar-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient with unknown demographics who had excursion at temperature of 48 degrees f lasting for 96 hours due to the refrigerator being left openwith no reported adverse event while receiving vaccines DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] and IPV (VERO) [IPOL] and while treated with TUBERCULIN TEST [TUBERSOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient started taking TUBERSOL (TUBERCULIN TEST) Solution for injection dosage unknown (with an unknown batch number) for Immunization.  On an unknown date, the patient received a  dose of suspect IPV (VERO)with unknown dosing, lot T1D481M via unknown route in unknown administration site for immunization.  On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT with unknown dosing,lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient had excursion at temperature of 48 degrees f lasting for 96 hours due to the refrigerator being left openwith no reported adverse event (product temperature excursion issue)(unknown latency) following the administration of IPV (VERO) and (unknown latency) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (experienced excursion at temperature of 48 degrees F lasting for 96 hours due to the refrigerator being left openwith no reported adverse event).  At time of reporting, the outcome was Unknown for the event experienced excursion at temperature of 48 degrees f lasting for 96 hours due to the refrigerator being left openwith no reported adverse event.
unspecified severe reaction; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 6 months after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. Approximately 18th september 2019, the patient received 1st dose of Shingrix on the left arm and had an unspecified severe reaction. The reporter did not describe the severe reaction. The reporter declined to provide further information for safety report.
fever and chills for 48 hours after vaccination (100.4 degrees under the arm for day one, 99.4 degrees for day two), aches, strong headache for 48 hours after vaccination (resistant to ibuprofen), pain in joints around shoulder and neck, nausea and vomiting 24 hours after administration of vaccine, foggy brain.
I went to emergency clinic due to my COVID-19 symptoms. I took a home test and was positive 01/12/2023 for COVID-19. I developed chills and a low grade fever and had flu like symptoms. I developed a cough, and I could not breath, was so congestion, had phlegm. I was concerned it would go into my lungs. I saw a physician assistant in the emergency clinic 01/30/2023. I still have a bit of hoarseness at times but feeling better.
Information has been received from a registered nurse concerning a 13 year old female with no known allergies or medical history, who on 07-AUG-1997 was vaccinated subcutaneously with a first dose of VARIVAX (Merck) (Lot # 623133/0690E) and on 15-JUL-2008 with a second dose of VARIVAX (Merck) (Lot # 661120/0538X) in the right arm and concomitantly on the same date, with Hep A (MSD) (Lot number not provided) on the left arm. The patient developed a hard lump, erythema, and swelling at the injection site on her right arm after administration of her second dose of VARIVAX (Merck) and a dose of Hep A (MSD). The VARIVAX (Merck) was administered in her right arm. The Hep A was administered in her left arm. The patient sought medical attention via telephone. At the time of the report, the patient has not recovered. There was no product quality complaint. Additional information has been requested.
MODERNA mRNA COVID-19 Vaccine (1st Dose)  Lot# 019B21A  EXP: 09/21/2021 INJ SITE: RT DELTOID  PT MONITORED FOR 15 MIN POST VACCINE, WITH IN THE FIRST 5 MINUTES OF HAVING THE INJECTION MONITORED PT AND NOTED TO HAVE SWELLING OF THE RIGHT SIDE OF THE TONGUE AND THROAT. PT HAD BP CHECKED 134/82, PULSE WAS ELEVATED AND O2 HAD DECREASED. PT RECEIVED A  STEROID INJECTION AND EXTENDED MONITORING. PT GIVEN O2 FOR COMFORT AND PRECAUTION, AND PT CONTINUED TO DO WELL. PT WAS GIVEN INFORMATION ON VAERS SIGN UP, AND ENCOURAGED HER TO SIGN UP FOR IT. PT WAS RELEASED FROM OFFICE AFTER AN HOUR AND NO ADDITIONAL SIGNS OF REACTION OCCURING.  PT ADVISED THAT THEY COULD NOT GET THE SECOND INJECTION DUE TO REACTION.
Started with a severe headache Thursday evening then added fever, chills, fatigue, and muscle aches all day yesterday. Slight improvement this morning.
Woke up 0230 with severe chills but skin was hot (according to my wife). After several hours of sleep I got out of bed around 0600 and noticed severe body and joint ache and a headache. Once I began moving around I also noticed I would fatigue very quickly. Reminded me of how one feels when they get a good case of the Flu. As the day progressed all symptoms lessened in severity and I went to bed at about 20% of what I felt that morning. I woke the following morning and felt no residual symptoms.
Swelling of throat and unable to eat for 48 hrs, blurred vision, fever ~ 102°F, swelling of hands/arms and feet/legs, headache, bedridden, dizzy spells during the first 4 days. Ongoing for 9 weeks, shortness of breath and unable to return to daily activities.
This case was reported by a nurse and described the occurrence of injection site reaction in a 12 month old female pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On 12May2003, the pt received Infanrix. On 12May2003, the pt also received Haemophilus influenzae type b vaccine, and 7-valent pneumococcal conjugate vaccine (Prevnar) Two days later, on 14May2003, the pt experienced an injection site reaction with redness, swelling and pain at the Infanrix injection site. The pt was seen at the physician's office. The events resolved. The nurse considered the events possibly related to vaccination with Infanrix.
Heart blockage that I never had before; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Aug2022 at 12:45 as dose 2, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: ATRIOVENTRICULAR BLOCK (non-serious) with onset 23Nov2022 at 15:00, outcome "recovering", described as "Heart blockage that I never had before". The event "heart blockage that i never had before" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of atrioventricular block.  Additional information: There were no other vaccine in four weeks. The patient was tested for covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 03-22-2021, mild symptoms. I thought it was allergies. In 03-31-2021 had a culture. I felt my lymph nodes in my throat on the inside and outside of my throat and chin on the sides of my chin. It was very strange how I felt, the culture in the clinic was negative. Strep throat was negative.  I was given antibiotics and felt better since. It was a bacterial infection as per her doctor.  I felt better but sometimes when I swallow I feel my lymph nodes a bit swollen.
reported no s/s of adverse reaction at time of vaccination and for 30 minute post-vaccination monitoring period.  States that approximately 4 hours after administration , he had elevated BP (148/92) and heart rate (115bpm).  Normal readings are HR in the 60s-70s and "normal" BP 120/60s.  Had fever of 102 the first night that lingered for 48 hours, accompanied by extreme fatigue, nasal congestion, shortness of breath, decreased appetite,  He took tylenol for fever and afrin for nasal congestion.  By the 26th, he felt well enough to get dressed.  No fever, appetite back to normal.  BP on the 26th was normal to low and heart rate 105.    Adverse reactions required no further treatment.
3 days post Vaccination: fever, body aches, headache, fatigue, chills,
Injection site was red, hard and hot, looked aggravated; Injection site was red, hard and hot, looked aggravated; She started to ache a little at the injection site; Injection site was red, hard and hot, looked aggravated; This spontaneous case was received on 04-Sep-2020, from pharmacist (reference number: SEQW20-01270) and concerned a 72-year-old, female patient.  The patient's past medical history included hospitalisation in 1970s once due to a flu vaccine. The patient's concomitant medications were not reported.   On 31-Aug-2020, patient was vaccinated with unspecified Fluad Quadrivalent [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose: 0.5 ml, route of administration, anatomical location: not reported] for influenza prophylaxis. The batch number reported was 279787, expiry date: 18-May-2021.  On 01-Sep-2020, on Tuesday, the patient started to ache a little at the injection site and then at night the injection site was red, hard and hot, looked aggravated.   On 03-Sep-2020, the patient called health care professional (HCP) and was advised to place warm packs on the site and if not better schedule an appointment to see the HCP.  At the time of initial reporting on 04-Sep-2020, the patient was recovering from the events. The patient stated it has started to go away now, but still pink with a hard spot where injection was administered.  The reporter did not provide a causality assessment.   This case is linked to case number 202004317 (the same reporter).  Company comment: The patient developed all events one day after vaccination with the suspect product, Fluad Quadrivalent. Chronology is plausible. No alternative aetiology was provided. Based on provided information, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).; Sender's Comments: The patient developed all events one day after vaccination with the suspect product, Fluad Quadrivalent. Chronology is plausible. No alternative aetiology was provided. Based on provided information, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).
SYMPTOMS OF FEVER; FATIGUE; This spontaneous report received from a patient concerned a 39 year old male. The patient's weight was 332 pounds, and height was 75 inches. The patient's past medical history included: cigarette smoker, and concurrent conditions included: allergic to mushroom, and non alcohol user, and other pre-existing medical conditions included: Patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 19-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 19-AUG-2021, the patient experienced symptoms of fever. On 19-AUG-2021, the patient experienced fatigue. On 23-AUG-2021, Laboratory data included: COVID-19 virus test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the symptoms of fever and fatigue was not reported. This report was non-serious.
rash quickly; I'm 2 weeks in . Got vaccinated 6 months ago but still happened/ suspected vaccination failure; still happened; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In MAR-2023, the patient received Shingles vaccine. In SEP-2023, between 5 and 6 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I'm 2 weeks in . Got vaccinated 6 months ago but still happened/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still happened). On an unknown date, the patient experienced rash (Verbatim: rash quickly).  The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved and the outcome of the rash was resolved.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and rash to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 The case was received from the patient via interactive digital media. The patient got vaccinated 6 months ago from reporting but still (shingles) happened and the patient was 2 weeks in. The doctor stated it was uncommon. However, it did reduce the severity and duration the patient was told. The patient tend to believed that as his/her more tolerable compare to other and Valtrex stopped rash quickly. This case was considered as suspected vaccination failure since the details regarding the completion of vaccination schedule and laboratory confirmation of shingles was unknown at the time of reporting.