chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vial initially stored in refrigerator on 04-Jun-2022 and administered on 20-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 20-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 20-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 20-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 20-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 20-Jul-2022).    Concomitant medication information was not provided by the reporter.  Patient received half dose.   Vial was initially stored in the refrigerator on 04-Jun-2022.  Vaccine administered to 346 patients after the 30 day by used involved 35 vials. Vial did not undergone any temperature excursions.  Treatment information was not provided by the reporter.
aching chest all the way across and down to my elbows on both arms; unable to sleep.; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 11Mar2021 08:45 (at the age of 67-year-old) as dose 2, single for COVID-19 immunisation at other facility. The patient medical history was not reported. Concomitant medication included atorvastatin taken for an unspecified indication, start and stop date were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunisation. The patient had no known allergies. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The evening of the vaccination date (11Mar2021 at 21:00), he had an aching chest all the way across and down to his elbows on both arms, was unable to sleep and was not head achy. Do not think he had a temperature. It was improving "this" morning. It was currently 23.5 hours after receiving his 2nd dose. The patient did not receive any treatment for the events. The outcome of the events was reported as resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Initial information received on 30-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 14 years old male patient who received FLUBLOK QIV instead of FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included GARDASIL for Immunisation in the right deltoid. On 30-Nov-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: QFAA1824, expiry date: 30-Jun-2019, dose in series not reported) via unknown route in the left deltoid. This was a case of actual medication error due to wrong vaccine administered because FLUBLOK QUADRIVALENT was given instead of FLUZONE QUADRIVALENT and inappropriate age at vaccine administration because 14 years old patient was given FLUBLOK QUADRIVALENT. It was not reported if any adverse event occurred or not. 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. Documents held by sender: none.
About 40 mins after receiving the vaccine, I started experiencing what I would say was dizziness. I was sitting at my desk and the room seemed to shift on me. Also, my head was feeling funny. I went back to the vaccination area and reported that I thought something wrong. The nurse tested my blood pressure and and it was 100/60.  She gave me Benadryl and I was observed for a little until I was able to go back to my workstation. Abut 2 hours later, they called to find out how I was feeling. I told them at the time I was experiencing chills. They asked if had Tylenol which I did not so they requested that I come back to the clinic. They gave me Tylenol and recommended I continue taking the Tylenol throughout the day.
Pt recvd vax & had insomnia, fatigue back hurts between shoulder blades when inhales or is uncomfortable, rt side of neck is stiff & sore; seen by a MD; pain between shoulder blades & rt neck stiffness & soreness;
Soreness and headaches the first 4 days which I expected was just normal. Headaches did not go away and experienced chest pressure and fatigue. Went to doctor when chest pressure and headaches didn't go away. I am still experiencing chest pressure and headaches everyday. I am monitoring my blood pressure In a log for the doctor to proceed further
Patient has a knot under her skin near the injection site 2 days after receiving her second dose of the vaccine.
arthralgia 2nd, 3rd MCP joints beginning 6 wks & lasting 8 wks p/last vax;
Fever, body aches, chills, nausea for 1.5 days after vaccine. Fainting episode 1 day after receiving vaccine.  Severe pain and redness on injection site and swelling  x 3 days. Took Tylenol and Ibuprofen for fever and pain.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 68 year female. Initial information was processed with the additional information received on 10-MAY-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: mild occasional asthma, and allergy. The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 06-MAR-2021 for prophylactic vaccination.  Age at time of vaccination 67 years old. No concomitant medications were reported.  The patient additionally received Pfizer Biontech covid-19 vaccine (tozinameran, dose number in series 2) (form of administration, route of administration, batch number were not reported), dose was not reported, received on left arm on AUG-2021 for prophylactic vaccination. No adverse events reported after Pfizer Biontech covid-19 vaccine (dose number in series 2). Non-company suspect vaccine included Moderna covid-19 vaccine (elasomeran, dose number in series 3) (form of administration and route of administration were not reported, batch number LGH022887060) dose was not reported, received on left arm on 08-JAN-2022 for prophylactic vaccination.  On an unspecified date in 2022, the patient experienced COVID-19. It was reported as, five days after completing a five days treatment (from 17-APR-2022 to 21-APR-2022) with Paxlovid (nirmatrelvir and ritonavir) all symptoms disappeared and patient was tested negative. On 25-APR-2022, the symptoms reappeared and patient was tested positive ((confirmed covid-19 infection, dose number in series 3) and (confirmed clinical vaccination failure, dose number in series 1)).  The patient continued to test positive over four days and finally tested negative on 30-APR-2022 (5th day).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with elasomeran was not reported. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000230235.; Sender's Comments: V0: 20220517622-Covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
PATIENT STATES THAT HE HAD SOME LOCALIZED BLISTERING AT SITE OF INJECTION(S) THAT BEGAN ON 9/20. HE STATES THAT IT HAS NOT WORSENED.
This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 12-NOV-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot# L013428, expiry date 03-FEB-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to two separate temperatures excursion (date unspecified): lasting for 136, 24 and 80 hours, with the lowest recorded temperature of 30, 31 and 34 degrees Fahrenheit, respectively. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 52 year old female patient. The patient had no drug reactions/allergies. On 15-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot# J004599, expiry date: 18-JUL-2014) (dose unspecified) subcutaneous at right arm. Concomitant therapies included with LUNESTA, SOMA, TOPAMAX, enalapril maleate, ZOLOFT, LAMICTAL and BUPAP. Pharmacist reported that the patient developed a red wheal at the injection site after vaccination with ZOSTAVAX. BENADRYL as a treatment was given for the event. The patient had sought medical attention via contacting pharmacist. At the time of report, the outcome of the event was not recovered. Additional information has been requested.
Two days after, I was hot and then two days after that I was freezing - was sleeping most of the time. Walked like I was 90 yrs old, legs hurt so bad.
Patient had 2 Pfizer COVID vaccines and was hospitalized on 1/2/2022 for COVID
pt became irritable 1-1 1/2hrs p/vax;was sleeping prior to irritability;mom gave APAP put pt down & noticed pt was ashes & cyanotic;responded p/being picked up & handled but did not breathe for short period of time;taken via amb to hosp
Tested Positive for SARS CoV 2 RNA; collected on 15Nov2021; Resulted on 17Nov2021; Tested Positive for SARS CoV 2 RNA; collected on 15Nov2021; Resulted on 17Nov2021; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP6955), intramuscular on 24Mar2021 (at the age of 43-year-old) as DOSE 2, SINGLE for covid-19 immunization. Medical history included asthma. The patient's concomitant medications were not reported. Past drug included Macrobid and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. The historic vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247), intramuscular on 02Mar2021 (at the age of 43-year-old) as DOSE 1, SINGLE for covid-19 immunization. The patient tested positive for sars cov 2 rna; collected on 15nov2021; resulted on 17nov2021. No treatment was received due to adverse events. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 17Nov2021. Outcome of the event was Recovering.  Follow-up attempts are completed. No further information is expected.
Felt extremely tired for 6 weeks after vaccination. Abnormal liver labs just started 5 weeks after vaccination. Diagnosis of Primary Biliary Cirrhosis in September at clinic.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 21-DEC-2018, the patient was vaccinated with improperly stored VAQTA (lot # R013859, expiration date 14-JUN-2019) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Pt with  abdominal pain prompting eval / pt with SI  enlarged  spleen /  EBV titers show past   EBV covid  antibodies positive
Sudden onset of vomiting lasting 2-3 hours. Chills for 1 hour. Fever for 1 day. Fatigue for 2 days.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 16-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired in 04-Mar-2012. On 13-Mar-2012, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 16-Apr-2012: No late occurring adverse events were reported.
got my flu shot, and still got the flu; Initial information received on 10-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who got my flu shot, and still got the flu while receiving vaccine influenza vaccine.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer (dose, strength, frequency, formulation, route, batch number, expiry date: unknown)  via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient had a non-serious got my flu shot, and still got the flu (vaccination failure) (unknown latency) following the administration of influenza vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown
Red patch (approximately 3" diameter), bit swollen, itching - hydrocortisone cream or BENADRYL.
Pt received J&J on 3/10/2021 from a different location, did not report this on consent form and was also given 2 doses of Pfizer. (4/20/2021 and 5/11/2021).  Did not discover pt had received J&J until processing prescription after administration and insurance rejected claim.
Within 24 hours developed redness and swelling. Worsened over the course of several days. Sought medical care 2/22/14 and was diagnosed with cellulitis. Was given a course of antibiotics with subsequent resolution of problem. Did note fever also prior to medical care and treatment.
noticed that the injection site is red like a light sunburn; noticed that the injection site kind of itches; noticed a lump at the injection site; her left arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (noticed a lump at the injection site), MYALGIA (her left arm hurt), VACCINATION SITE ERYTHEMA (noticed that the injection site is red like a light sunburn) and VACCINATION SITE PRURITUS (noticed that the injection site kind of itches) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078C21A and 029L20A) for COVID-19 vaccination.     The patient's past medical history included Pulmonary fibrosis in 2010.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (her left arm hurt). On 17-Aug-2021, the patient experienced VACCINATION SITE MASS (noticed a lump at the injection site). On 18-Aug-2021, the patient experienced VACCINATION SITE ERYTHEMA (noticed that the injection site is red like a light sunburn) and VACCINATION SITE PRURITUS (noticed that the injection site kind of itches). At the time of the report, VACCINATION SITE MASS (noticed a lump at the injection site) had not resolved and MYALGIA (her left arm hurt), VACCINATION SITE ERYTHEMA (noticed that the injection site is red like a light sunburn) and VACCINATION SITE PRURITUS (noticed that the injection site kind of itches) outcome was unknown.            Concomitant medications were not reported. Treatment medications were not reported.  The reporter states that the patient took the booster dose as the patient is immunocompromised due to pulmonary fibrosis from chemotherapy in 2010.
Pt recv vax on 4/21/99; on 4/22/99 pt exp dark erythematous induration at vax site, erythematous maculopapular rash on lower chest & upper abdomen
Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Slight fever) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Slight fever). At the time of the report, PYREXIA (Slight fever) had resolved.            No relevant concomitant medications were provided. No treatment information was provided. The action taken for mRNA-1273 was not applicable.    This case was linked to MOD-2021-066319 (Patient Link).
Child's mother, a pediatrician, received FluMist (LAIV) on the specified date. The child, who did not receive FluMist, became ill with "flu like" symptoms 15 days later. It was reported that the "whole family became ill". An influenza virus (wild type, not vaccine strain) was isolated from the child from a sample taken one day after onset of illness.
Information has been received from a physician's office concerning a 4 year old white female who on 11/30/00 was vaccinated with a dose of varicella virus vaccine live. Concomitant vaccination on the same day included a dose of MMR. There was no illness at the time of vaccination. In the morning of 4/21/04, the patient developed chicken pox after having been exposed two weeks prior at a babysitter's. The patient had a cough and developed pneumonia after chicken pox. Subsequently, the patient recovered. Additional information is not expected.
Patient presented to the office with spreading rash approximately 2 weeks post vaccination and Dx with Varicella post vaccination.
VAERS website timed out after 20 minutes and erased my detailed log, so this is a condensed version.  8 days after 3rd dose. Resumed regular barbell strength training after a rest week and within 30 minutes, had intense chest pain around left rib cage, trapezius, and injection site. Not DOMS. Pain 3-5 during day and 6-8 at night, keeping me awake. 600mg Ibuprofen helped with pain. Teladoc said it was likely pleurisy. Could not see urgent care because they were closed over New Year's. Could not see PCP because office was closed for Omicron surge.  Teladoc said pleurisy "is not an uncommon side effect" and the likely diagnosis because pain increased when lying down. Likely not heart-related inflammation because my HR was in low-50s (normal RHR is mid-40s). PCP over video conference said pleurisy is not a typical side effect of the vaccine. So who knows, but I have never had chest pains, heart issues, lung issues, etc. and am a healthy athlete.  Days 8-12 post-vaccination. Symptoms began and got worse over those 4 days. Gradually improved days 13-20. Sleeping on back with back propped up helped. 600mg Ibuprofen helped.  Day 20: Felt normal. Resumed light exercise (running, lifting) with just a little heaviness in the chest, but no pain. A week later, all was normal, but pretty scary to have had that kind of chest pain.
Immunizations administered on 01/24/08.  Rash started on 01/29 at 700am.  Large areas of hives-whelps (raised & red) all over body.  Eyelids swollen, feet swollen.  Has run some fever yesterday and a little today.  Some itching.
MODERNA COVID-19 Vaccine. "COVID Arm"  Itching and red swelling appearing  on arm  after 10 days covering an area of approximately 2" x 4 1/2".  Lasted for 3 days and then diminished.
tingling in right arm; itchy; breakout on neck; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in right arm), PRURITUS (itchy) and RASH PRURITIC (breakout on neck) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Victoza, ) and Drug allergy (Byetta).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (tingling in right arm), PRURITUS (itchy) and RASH PRURITIC (breakout on neck). At the time of the report, PARAESTHESIA (tingling in right arm), PRURITUS (itchy) and RASH PRURITIC (breakout on neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: TCR form received on 14 JUL 2021: Declined for follow up.