chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-AUG-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N012491 with expiry date 17-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006208.
Woke up at 3:30am with severe chills and night sweats, could not get warm. Fever (101.7) started at 8am 1/10 .  took Acetaminophen 1000mg for fever, headache, body aches, and weakness in extremities , increased fluids. Noticed a swollen sub clavicular lymph node on the left side That grew to the size of an almond. Migraine started at 11am same day. Took PRN Maxalt for Migraine and slept the rest of the day.  Next day  (1/11) slight headache that waxed and waned the rest of the day. Fever of 100.1 by 2:30 that same afternoon. Took Acetaminophen and fever resolved  by the next day. Was seen for lymph node a week later by PCP and sent for an ultrasound.  On 2/5 was scheduled for biopsy but on Ultrasound the lymph node had decreased in size from 2cm to 1.5cm on its own. Decided to hold off. Lymph node is now normal in size
Right anterior thigh with 10.0 x 10.5 cm area of erythema, induration, some tenderness to palpation noted by mom on morning of 11-7-13.
Vasovagal response with no evidence of complete loss of consciousness. Pt was not replying to verbal commands for approx 20 seconds until pt was placed on the ground supine position with feet elevated approx 12 inches. Immediately after legs elevated, member was responsive but was confused as to why people were asking him if was okay. States does not recall any events after sitting down for approx 10-15 minutes of receiving vaccine. Member was observed for another 45 min to 1 hour before released. No other signs and symptoms.
Reported site swelling, pain, rash and itching at the site of ther shot.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 2:19 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 2:19 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 30.66 for dose administered on 07-Jan-2021. No concomitant medications were reported.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
Patient was using her walker and leaving the vaccination site and fell down. She fell on her face and hit her head resulting in a cut that caused blood. The police and EMTs were called and came within 5-7 minutes. Patient vomited upon sitting on the stretcher. She was awake and alert but was obviously in discomfort due to the fall. She was transported to the local hospital.
The physician advised holding off on the 2nd dose; bell's palsy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BELL'S PALSY (bell's palsy) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 0111d21d) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bell's palsy (Patient had Belles's palsy past (15 years ago).) in 2000. Concurrent medical conditions included Hypothyroidism (no recent change in status of chronic condition: stable) since 2000. Concomitant products included LEVOTHYROXINE for Hypothyroidism.   On 02-Feb-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021 at 5:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced BELL'S PALSY (bell's palsy) (seriousness criterion medically significant). On 16-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The physician advised holding off on the 2nd dose). On 16-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The physician advised holding off on the 2nd dose) had resolved. At the time of the report, BELL'S PALSY (bell's palsy) was resolving. Not Provided          Treatment information was not provided.  This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: Not provided) with an associated event of Facial Paralysis. Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded. However, patient's prior medical history of Bell's palsy may have been contributory.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Up on internal review on 04-Aug-2021, Event Inappropriate schedule of vaccine administered start date is updated to (16-MAR-2021), Its crossed -25-35 day window.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: Not provided) with an associated event of Facial Paralysis. Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded. However, patient's prior medical history of Bell's palsy may have been contributory. The causality for the event of inappropriate schedule of vaccination remains as not applicable.
Pain at injection site- worsened after 24hrs.  prolonged recovery. Erythema at injection site worsened after 24hours-  present for greater than a week. Worsening abdominal pain 3 weeks post injection.  Still persists sweating and night sweats -  significant post injections days one  appetite changes Headaches-  severe persistent and nearly daily prolonged recovery, recovering  Fatigue and lethargy. - persists muscle weakness-  persists Sleep disturbnce  difficulty staying sleeping since injection.
pt recv vax & approx 4 days p/vax pt devel syncope & fever;approx 1-2mo later pt devel heart failure & ventricular tachycardia & was dx w/cardiomyopathy;the most recent recv 3APR97 reports the outcome as unk;
My breathing was little bad too; My blood pressure went up like 240; I have trouble with my blood pressure high and low; My blood pressure went up like 240; I have trouble with my blood pressure high and low; This is a spontaneous report from a contactable consumer (Patient). A 77-year-old patient of an un-specified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number, UPC and NDC number and Expiration date: Unknown) via an unspecified route of administration (age at vaccination 78-year) on 19Mar2021 as dose 1, single for COVID-19 immunization. No medical history and concomitant medications were reported. On an unspecified date (probably 3-4 days later), patient's blood pressure went up like 240; patient had trouble with blood pressure high and low and breathing was little bad too. Patient was on oxygen for bad breathing. The patient underwent blood pressure measurement: went up like 240 and was low on an unspecified date. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Stopped getting them and stopped getting sick; Initial information received on 29-Dec-2021 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced stopped getting them and stopped getting sick 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 a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date the patient developed a non-serious stopped getting them and stopped getting sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Stopped getting them and stopped getting sick).  At time of reporting, the outcome was Unknown for the event stopped getting them and stopped getting sick.
30Apr92 pt recvd 2nd dose of vax 5-10 min p/vax pt exp an "allergic rxn"(type 1)-itching, ringing in ears, heat over body, tightness of chest & closing of throat.Events reported as life threatening. Pt taken to hospital and D/C same day.
Fever, chills, aches, cough, fatigue for 2 days Pain, swelling, itching, large red patch (3"x5")at injection site
Fever 99-100, mild muscle aches, injection site pain. Nausea for about 2 hours beginning approximately 18 hours after injection. Woke up on 04/24/2021 with no lingering symptoms or fever.
This spontaneous report was received from a pharmacy intern and refers to a 5 weeks old patient of unknown gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 24-JAN-2017, the patient was vaccinated with 0.5 ml of 1 ml adult dose of RECOMBIVAX HB (route of administration, lot # and expiry date were not reported). No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
More than 36 days from first vaccination, not able to get second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 36 days from first vaccination, not able to get second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Removal of kidney stone (kidney stone removed, not related to vaccine). Concurrent medical conditions included Respiratory syncytial virus infection NOS (RSV, not related to vaccine) and UTI (not related to vaccine).    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 36 days from first vaccination, not able to get second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 36 days from first vaccination, not able to get second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided.  No treatment information was mentioned.
General feelings of fatigue,  chills, headache, no appetite,  sore at injection site, red area with hives midway  upper arm.
Had elevated pulse/ heart palpitations 5 minutes after receiving shot (150 bpm). This also caused anxiety for a few  hours after. I did not alert the staff at the center since the symptoms did not worsen (and no other symptoms occurred) after the initial rush of elevated heart rate. The same elevated heart rate happened during my first dose, however I thought it may have just been anxiety initially.
Patient had a fever of 103.5 for 3 days starting on 12/21/17. On 12/22/2017, he complained that his eyes burned. Closer inspection his eyes were irritated and red. He was lethargic, fatigued, irritable and had loss of appetite that did not return for 7 days after 12/21/2017. He had a mild rash on his torso. He had night terrors and sweats for 3 nights during the fever. He had a runny nose and sore throat that he complained about for 7 days after 12/21/2017.
One week after shot my right arm began itching at the injection site. My arm is red almost to my elbow and still itches. Also have a hard lump in my arm.
pain; Wrong route of administration; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 494PR, expiry date 13th September 2021) for prophylaxis.   On 17th May 2019, the patient received Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced pain and intramuscular formulation administered by other route. On an unknown date, the outcome of the pain and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced pain. The reporter stated that, the patient was inadvertently given Shingrix subcutaneously which led to intramuscular formulation administered by other route.
A female consumer reported that she received a dose of influenza virus vaccine, trivalent, types A & B in 1998. Medical history included allergy to sulfonamides. Subsequent to immunization, she experienced soreness at the injection site on her arm, which lasted 1-2 days. She reported that she experienced the same reaction after she received influenza vaccine in 1999, 2000, and 2001. No further information was available as of the date of this report.
Fever; headache resulting in inability to attend work.; body aches; headache resulting in inability to attend work; This is a spontaneous report from a non-contactable consumer or other non-health care professional (patient). A 22-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration (at the age of 22-years), administered in arm right on 11Feb2021 at 13:15 as dose 2, single for COVID-19 immunization. Medical history included none from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration (at the age of 22-years), administered in arm right on 21Jan2021 at 13:15 as dose 1, single for COVID-19 immunization. The patient had no known allergies. The patient did not receive and any other vaccine in four weeks. The patient does not have covid prior vaccination and had not been tested for covid post vaccination. On 11Feb2021 at 18:00, the patient experienced fever, body aches, headache resulting in inability to attend work. The treatment was not received for the events. The facility type of vaccine was reported as workplace clinic. The clinical outcome for the events was reported as recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information expected
Patient received 2nd dose of Moderna at age 17 and did not meet age criteria for eligibility. No adverse effect or reaction was reported by the patient.
edema, soreness lt upper arm, axilla lt chest area;sl edema noted 30SEP;no redness;c/o cephalalgia 28SEP;
myalgias, GI upset, n/v, dizzy-much worse than prev rxn to initial dose 6MAR94;
TIA diagnosis at hospital; Conscious after fall; Dizzy/ lightheadedness; Head bump (temple area and ear caused by hit sink during fall); A spontaneous report was received from a consumer who was also a 90-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced transient ischemic attack, fall, dizzy lightheadedness, and a head bump.   The patient's medical history, as provided by the reporter, included transient ischemic attack; the patient experienced 3 events in 2020.  No relevant concomitant medications were reported.   On 23 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number 030L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 25 Jan 2021, the patient experienced dizzy lightheadedness and a fall, resulting in a head bump in her temple and ear caused by hitting the sink as she fell. The patient was hospitalized following the fall and diagnosed with transient ischemic attack.   On 26 Jan 2021, the patient received magnetic resonance imaging and a laboratory test.  On 27 Jan 2021, the lightheadedness and head bump had resolved.  Action taken with mRNA-1273 in response to the event(s) was not reported.   The outcome of the events, transient ischemic attack and fall, was considered resolved on 25 Jan 2021. The outcome of the events, lightheadedness and head bump, was considered resolved on 27 Jan 2021.; Reporter's Comments: This case concerns a 90-years-old female patient with a relevant medical history of three TIA within last year, who experienced a serious unexpected event of Dizziness and Transient ischaemic attack and non-serious unexpected events of Fall and Head injury.  The events of occurred approximately 2 days after first dose of mRNA-1273, lot # 030L20A. Treatment details were not provided.  Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded. However, patient's advanced age and prior history of TIA are considered significant confounders.
At approximately 0943 patient reported feeling faint, starting to lose vision, and nausea.  Lead nurse was notified and patient was assisted into anti-gravity chair.  Patient assessed. Pallor noted and patient reported feeling hot and stated "I'm going to throw up".  Patient given emesis bag at approx. 0944. Patient reported feeling better. Patient given water.  patient denied rashes, hives, and throat irritation. Patient reported feeling scared of needles and no history  of fainting after prior vaccinations. Vitals assessed at 0946:  BP 90/75 mmHg, SpO2 99% RA,  PR 75 bpm.  Pt advised to stay for 30 mins for further observation. Vitals reassessed at 1004: BP 100/80 mmHg, SpO2 99% RA, PR 56 BPM.  Vitals reassessed at 1020:  BP 80/50 mmHg,  SpO2 99% RA, PR 60 BPM. Pt advised to wait 20 mins due to drop in BP.  Vitals reassessed at 1040: BP 100/80mmHg, SpO2 99%,  PR 65 BPM. Patient denied throat irritation and stated she was feeling better. Patient advised to sign up on CDC- V-safe. Pt left facility at approx. 1045 with steady gait and unlabored breathing.
HCP called for temperature stability evaluation of vaccines and reported that 10 pediatric patients received PROQUAD vaccine since excursion date on 7/14/2022, no exact dates provided; This spontaneous report has been received from a medical assistant concerning a 3-year-old male patient.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On an unknown date in 2022, the patient was vaccinated with the a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) (rHA) subcutaneous injection, 0.5 milliliter, once (lot number W016358 has been verified to be a valid lot number for mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) (rHA), expiration date reported and confirmed as 16-NOV-2023) (route of administration and anatomical location were not provided) as prophylaxis. According to the temperature stability evaluation of vaccines, the vaccine administered had been suffered a temperature excursion since 14-JUL-2022, no exact dates provided (Product storage error).  This is one of ten reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA004135: US-009507513-2208USA004086: US-009507513-2208USA003812: US-009507513-2208USA003988: US-009507513-2208USA004011: US-009507513-2208USA004012: US-009507513-2208USA004255: US-009507513-2208USA004223: US-009507513-2208USA004255:
Patient appeared pale, light headacheness, near fainting, tunnel vision, skin cold and clammy within 10 minutes of 2nd Pfizer injection. Patient rested on gurney and felt better. 1st BP taken at 10:45 BP 85/47, HR 56. 2nd BP taken at 10:55 BP 95/57, HR 61.  Patient left the facility 30 minutes after his vaccination with stable condition.
11/1/21 "history of CVA, DM2, HLD, HTN, asthma, transferred from OSH for hypoxia w/ increased O2 demands 2/2 COVID PNA. Pt reports ~6 days of COVID-like sx including nasal drainage, cough, myalgias, fevers, chills"
No additional AE information provided; The patient was administered an improperly stored dose of ROTATEQ / Temperature ABOVE 47°F 52. F / Time frame 15 minutes / Previous temperature excursion? Yes ABOVE 47°F 55F 21 minutes; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications were not reported.  On 09-MAR-2020, an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, lot number 1660112 with expiration date 18-OCT-2020 (which had been verified to be valid lot number and expiration date for rotavirus vaccine, live, oral, pentavalent) was administered to the patient by oral route for prophylaxis (dose was not reported); the vaccine had temperature excursions of 55 degree Fahrenheit (F) for 21 minutes and 52.1 F for 15 minutes (which were both above 47 F), which were detected by the data logger. No adverse event was reported.