chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 31-Mar-2022; Received vaccine past its 30-days Exp date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date) and PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 31-Mar-2022) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022 at 11:54 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Mar-2022 at 11:54 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 31-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date) and PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 31-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  It was unknown if any prescriptions, over-the-counter-medications, dietary supplements, or herbal remedies were being taken by the patient at the time of vaccination and/or at the time of the adverse event. It was unknown if other vaccines were given on the same day or within one month prior to any dose of Moderna COVID-19 Vaccine to the patient.  Patient received the additional dose.  It was reported that vaccines went into 2-8 C thaw state on or above 24-Dec-2021 and were administered up until the MFG expiry date of 04-Apr-2022.  No treatment medications were provided.   This case was linked to MOD-2022-542869 (Patient Link).
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose given to Paitent) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination. No Medical History information was reported.On 15-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose given to Paitent). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose given to Paitent) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported.It was reported that the patient was not comfortable to get re-vaccinated.No treatment medication was reported.
Side effect; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Side effect) 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 ADVERSE EVENT (Side effect). At the time of the report, ADVERSE EVENT (Side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided. No treatment medication information provided
Vaccine site without AC, 90F at time of incident. Pt became pale and diaphoretic approximately 5 minutes after covid vaccination, during 15 min observation period. Vital signs stable, pt showing no signs of anaphylaxis or allergic reaction. 911 called at 10:05am for further evaluation, called again at 10:14am. EMS arrived at 10:16am and took over care. Pt transferred via EMS to a local Hospital for further eval/observation.
Itching, swelling, and hardness around injection site.  Mild rash has developed the size of a golf ball.
Nine hours after shot was given (9pm), I began to feel general malaise and a fever beginning. By the time I went to sleep, around 2 hours later (11pm), I had chills and a fever of 103°F. Taking ibuprofen 600mg and some interrupted sleep has helped, but as of 6:30am the next day (today) I am still feeling all these symptoms, but to a lesser degree. It is likely that these symptoms will return as strong as before later today, but time will tell.
negative reactions usually set in 12 hours after the booster vaccine, clarified as injection arm hurts and felt sick; negative reactions usually set in 12 hours after the booster vaccine, clarified as injection arm hurts and felt sick; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (negative reactions usually set in 12 hours after the booster vaccine, clarified as injection arm hurts and felt sick) and MALAISE (negative reactions usually set in 12 hours after the booster vaccine, clarified as injection arm hurts and felt sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (negative reactions usually set in 12 hours after the booster vaccine, clarified as injection arm hurts and felt sick) and MALAISE (negative reactions usually set in 12 hours after the booster vaccine, clarified as injection arm hurts and felt sick). At the time of the report, PAIN IN EXTREMITY (negative reactions usually set in 12 hours after the booster vaccine, clarified as injection arm hurts and felt sick) and MALAISE (negative reactions usually set in 12 hours after the booster vaccine, clarified as injection arm hurts and felt sick) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided.
This spontaneous report as received from a pharmacist refers to a 73 years old female patient with allergic to sulfa. The patient has no pertinent medical history. The patient was vaccinated with, 1 vial ZOSTAVAX (lot number reported as H0100427; Expired date 12-SEP-2013) subcutaneously on 11-OCT-2012 on unknown injection site. No other co-suspects were reported. No concomitant medications were reported. On 11-OCT-2012 the patient developed "a red ring" and soreness at the site of injection after receiving ZOSTAVAX. There was no treatment given for adverse events and no laboratory diagnostics study performed. The patient was not recovered at the time of report. The patient had called the pharmacist for medical attention. Additional information is not expected.
A month after the injection I suffered a from a stoke. I woke up one morning and didn't have any feeling on my left side of my body.  Until today I still feel weakness in my body.
Large red area (4" diameter) on left upper arm accompanied by fever, malaise, & swollen lymph nodes near clavicle.
Starting within 6 hours of administration, and clearing up completely within 18 hours: Fever, vomiting, diarrhea, elevated pulse rate, muscle cramps.
I was found to suddenly have developed hypertension in the neighborhood of 210/110 which was refractory to metoprolol and amlodipine.
Severe Fever and chills, severe headache resulting in nausea, full body muscle aches. No treatment received. Effects went from severe to moderate after 12 hours, then stayed moderate for an additional 36+ hours
Had headaches after both doses of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Had headaches after both doses of the vaccine) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Had headaches after both doses of the vaccine). At the time of the report, HEADACHE (Had headaches after both doses of the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported. No treatment information was reported by the reporter.   This case was linked to MOD-2021-358541 (Patient Link).
received the second dose of the vaccine 9 days ago, and 4 days after receiving it, I was diagnosed positive with covid; Received the second dose of the vaccine 9 days ago, and 4 days after receiving it, I was diagnosed positive with covid; This is a spontaneous report from a contactable consumer or other non hcp.     A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant was not reported.The patient experienced received the second dose of the vaccine 9 days ago, and 4 days after receiving it, person was diagnosed positive with covid (drug ineffective) (medically significant) on an unspecified date.The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of the event was unknown  Information on the lot/batch number has been requested.
Syncope lasting approx. 5 seconds. Pt became stiff and turned pale.
A company representative reported that a pt received an injection of flu shield. Subsequently, the pt developed an injection site reaction characterized by redness and swelling. No further info was available at the date of this report. The reporter was unable to specify the number of patients who experienced this event. Additional reports will be generated when identifying info is provided.
Her temperature was 101 degrees; her arm is swollen; Dizzy; Lightheadedness; Nauseous; Shakiness; arm swollen; back hurts; hot where she got the injection; arm hurt; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL0142), via an unspecified route of administration on Left arm on 08Feb2021 at single dose for covid-19 immunisation. Medical history included Flu on an unspecified date. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3246), at single dose for covid-19 immunisation. The patient reports, she received her second shot yesterday and her arm hurt like any shot would. She says today she feels really sick, after being fine yesterday. She says today she is dizzy and lightheaded. She says she took Advil, her temperature was 101 degrees Fahrenheit even with Advil, and every time she gets up she feels lightheaded and shaky. She says her back hurts when the Advil wears off, it is ok now because she is laying down, and she also feels a little nauseous. She says that her arm is swollen and hot where she got the shot, and this started today. She says that yesterday it just hurt like she got the flu shot. She says that she took Advil 200mg, she took two of them this morning at 06:00AM or 07:00AM, and then two more at 01:00PM. LOT: DY3057, EXP: May2023. She says by 11:00AM her fever was 101 degrees Fahrenheit, and now with the Advil it is 100.7 degrees Fahrenheit. Caller says that her lightheadedness and shakiness feel about the same. The seriousness was reported as non-serious. The outcome of the events unknown.  Information on the lot/batch number has been requested.
Swelling upper left arm, Red, hot bruising, Taking child to pediatrician's office, 08/23/02-talked with the child's father, Mom was @ doctor's office
12 Y/O FEMALE GIVEN PEDIATRIC DOSE OF VACCINE. NO ADVERSE REACTIONS
High fever, nausea, stiff neck 103 degree fever according to mother.  Did not go to ER, treated at home.
pt recv vax & following each vax pt exp a sore throat & h/a; each time the exp resolved w/o addtl therapy;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose number unknown (booster), single (Lot number: GJ2524) at the age of 30 years, in left arm for covid-19 immunisation. The patient's relevant medical history and 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: The patient received Paxlovid (anti-viral) for COVID-19 treatment, from 22Dec2022 to 27Dec2022.  No follow-up attempts are possible. No further information is expected.
uncontrollable shivering; 101.1 fever; severe headaches; could not stand; weak; dizzy; nausea; vomited; This is a spontaneous report from a contactable consumer (patient herself). A 68-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: not reported, expiration date: not reported), via an unspecified route of administration, administered in Arm Right on 12Mar2021 14:30 (at the age of 68 years) as dose 1, single in right arm for covid-19 immunization in hospital. Medical history included High blood pressure from an unknown date and unknown if ongoing, Chronic hives from an unknown date and unknown if ongoing, high cholesterol from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported; losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. Patient had no covid prior vaccination. Patient was not tested covid post vaccination. Patient had no other vaccine in four weeks. On an unspecified date in 2021, the patient experienced uncontrollable shivering, 101.1 fever, severe headaches, could not stand, weak, dizzy, nausea, vomited. Patient did not received any treatment. The patient underwent lab tests and procedures which included body temperature: 101.1 on an unspecified date in 2021. Clinical outcome of the events was reported as recovered on an unspecified date in 2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Non-painful, nonerythematous, edematous rash on L arm (same as vaccination site), with axillary spread
Blister lip; This non-serious case was reported by a consumer and described the occurrence of lip blister in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 07-OCT-2023, the patient received Shingrix. On 12-OCT-2023, 5 days after receiving Shingrix, the patient experienced lip blister (Verbatim: Blister lip).  The outcome of the lip blister was not resolved.   It was unknown if the reporter considered the lip blister to be related to Shingrix.     It was unknown if the company considered the lip blister to be related to Shingrix.   Additional Information: GSK receipt date: 14-OCT-2023 The concomitant product too many to list. The reporter did not consente to follow up.
Headache, chills, fever 99.3, nausea, severe arm pain, tired, sleepy.
This spontaneous report as received from a pharmacist refers to a 54 year old female patient. The patient pertinent medical history included asthma and peptic ulcer. The patient was allergic to AVELOX, erythromycin, LEVAQUIN and codeine. On 13-JUL-2016 the patient was inadvertently vaccinated with ZOSTAVAX (Lot M018593, expiry date: 28-JUN-2016) via intramuscular route rather than the recommended subcutaneous route. On 13-JUL-2016, following administration of ZOSTAVAX, the patient experienced a knot, the size of a golf ball appeared at the injection site on an unknown arm and the same unknown arm was described as a sore arm with pain radiating from injection site to top of the shoulder. The outcome of the events was reported as not recovered. The reporter did not provide the causality between the events and the suspect therapy. Additional information had been requested.
p/vax pt exp a fever of 104 & was shaky, jerky & fuzzy w/bilat leg pain;pt was treated w/APAP & given tepid baths;
One week after 1st vaccine I experiences swelling and  redness at the site, itching and soreness that did  not require any meds.  However  over the next week I developed allergic symptoms which increased daily until I was very symptomatic (coughing, trouble talking and breathing) and went to the doctor on Feb 6th where I was tested for DOVID and told to isolate (the test was negative) I was prescribed inhalers and antihistamines and the diagnosis was reactive airway disease. On March 1st I returned to see my primary care doctor and  have taken a regimen of antihistamines since then.
Patient received vaccine @ 1735, after receiving vaccine patient reported "feeling funny" & tingling to lips.  After 5 minutes of receiving vaccine patient then reported "feeling worse" & having a tightness to throat, Code Blue called, code cart & epi present. VSS, O2 sat 100%, BP 176/116, HR 88 bpm. ED code team arrived, patient stable and transported patient to ED via wheelchair for further evaluation.
Child began crying a high pitch cry for three + hours. Became very irritable, bilateral thighs red, and swollen, fever 102 and greater for 5 days. Child did fine on 2 month shots. Received DTaP, IPV, HIB & Prevnar 04/29*04.
Received vaccine 03/10/06 normal plt count 240 on 3/23/06 plt #3, petechial rash, afebrile. 4/14/06 Received hospital medical records for 3/24-3/26/06 admission w/dx TCP s/p 2 wks after Adacel.  Etiology of TCP thought to be meds vs vaccine vs autoimmune mediated ITP.  Mult transfusions of plts for recurrent very low plts. After starting dexamethasone & WinRho, improved & was able to be d/c home on steroids.  On 3/27 visit to PCP again had very low plts & restarted on steroids.  Hematologist felt ITP possibly related to erythroid reaction to temporary hemolysis induced by the anti-D.  Continues in f/u w/hematologist/ss
Symptoms began with a fever as high of 102 that lasted for about 2 days, and I tested positive for COVID-19.  On the second day my fever broke.  I had some productive coughing and congestion.  But I tested positive a second time on September 9, 2022.  I lost my sense of taste and smell the first time I tested positive.  This symptom lasted for about 3-4 weeks.  I also tested positive for Influenza A on November 15, 2022.
Woke next day with entire arm painful. The following day had pain all the way across his chest that lasted for 10 days along with the arm pain. Pain constant and unwavering. He was "laid up" for 10 days.  After 10 days pain resolved but then noticed cracking and popping of joints. Difficulty chewing due to jaw pain. Knees give out on him. Lasted 3-4 wks. Did see chiropractor.
VOMITING; COUGH; SWEATING; CHILLS; MUSCLE PAIN; NAUSEA; BODY ACHE; TIRED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, depression, and anxiety. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced tired. On 09-APR-2021, the subject experienced body ache. On 09-APR-2021, the subject experienced sweating. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced muscle pain. On 09-APR-2021, the subject experienced nausea. On 14-APR-2021, the subject experienced vomiting. On 14-APR-2021, the subject experienced cough. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sweating, and had not recovered from tired, chills, nausea, body ache, muscle pain, vomiting, and cough. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard operating procedures, as the case was assessed as non-serious.
FLUAD given to patient that was not over the age of 65. At time of reporting no adverse effects have occurred from vaccination.
if her recent experience of shortness of breath (beginning about 01Jun2021) could have a link to her recent 2nd Pfizer; This is a spontaneous report from a contactable consumer. An 82-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 17Apr2021 13:00 (at the age of 82-year-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. the patient was no pregnant. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Mar2021 12:45 for COVID-19 Immunization. The consumer questioned if the patient recent experienced shortness of breath (beginning about 01Jun2021) could have a link to her recent 2nd pfizer. The adverse event result in doctor or other healthcare professional office/clinic visit. The patient received treatment for AE. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included heart Stress Test scheduled end of Jun in Jun2021. The outcome of the event was resolving.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
One day post vax (07/13/1999)  pt developed an injection site reaction the size of a half dollar and by the next day (07/14/1999) it was the size of the bottom of a Coke can. Pt reported losing the feeling in the tips of 3 fingers on her left hand. Pt was treated with Benadryl and Naproxen. On 07/15/1999 the pt reported that she could not feel any of the fingers on her left hand and the injection site reaction covered the entire upper left arm with dull pain over the rest of the arm. Pt also reported experiencing muscle spasms in her left arm, neck, back and upper half of her left leg. Pt also experienced labored breathing. Pt was treated with steroids.