chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Skin rashes and hives. Occur at random places on body and last for anywhere from 10-20 minutes. Skin gets very itchy. Rashes will appear throughout the day. Some rashes appear in patches and some appear like scratch marks, even when the skin hasn?t been touched. Been taking 10 mg of Zyrtec and 10 mg of Pepcid twice a day.
Information has been received from a physician concerning a 15 year old female patient who on an unspecified date was vaccinated with the first and second dose of GARDASIL vaccine (yeast). The mother's patient informed the physician that her daughter was more tired now than she had been in the past. Additional information has been requested.
Had injection 2:30 pm 02/15/21; On 02/16/21 at about 11:30 am, muscle spasm in tongue (hurt like hell) 2/3 back from tip of tongue lasting a little over an hour.  IF it had lasted even a little longer, or pain had increased in the slightest, I would have headed to the emergency room.
Patient is a 74 y.o. female who presented from home on 12/12/2022 with altered mental status thought to be undiagnosed dementia. Expanded workup considered based on reported rapid progression but did not tolerate LP. Family elected to forego any further procedures. Found to have low B1 level. The patient was to be discharged on 12/30, though cancelled due to positive COVID test.  During hospital course patient had remained pleasantly confused, out of COVID isolation 1/8. Patient discharged on 1/9/23.
Information has been received from a office manager concerning a 71 year old male patient with hyperlipidaemia and with no drug reactions or allergies who on 15-MAR-2005 was vaccinated intramuscularly with the first dose of PNEUMOVAX 23 (lot # and dose not reported). On 12-MAY-2011 the patient was vaccinated intramuscularly with the second dose of PNEUMOVAX 23 (lot # 668008/1157Z, expiration: 08-MAR-2012) (dose not reported). Concomitant therapy included LIPITOR, testosterone gel, TRICOR and finasteride (MSD). The office manager reported that after receiving PNEUMOVAX 23 on 12-MAY-2011, the patient woke up in the morning of 13-MAY-2011 with redness, pain, rash and swelling below the injection site, on his right upper arm. "Steroid and antibiotic" were given for the adverse events. The patient sought medical attention by office visit. There were no lab diagnostics studies performed. At the time of reporting, the patient's status was unknown. Additional information has been requested.
got a flu shot got sick; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via Global Digital Media through social media  on 30-Nov-2020 .  This case involves an unknown age patient who got a flu shot got sick (malaise), while the patient was treated with INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, past vaccination(s) and family history were not provided.  On an unknown date in 2005 , the patient received suspect Influenza Vaccine produced by unknown manufacturer (lot number and expiry date not reported) at an unknown dose via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown in 2005 after 3 days of starting the suspect vaccine therapy, the patient got a flu shot got sick (malaise)   It was reported that patient believe they used the live virus back then.   Finally patient had one this Oct-2020 after 15 years with no shots and was fine.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of the reporting , event outcome was unknown .  There will be no information available on batch number for this case .
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. On 01-AUG-2017, the patient was inadvertently vaccinated with expired dose of GARDASIL 9 (dose and route of administration were not reported) lot # M014929 with expiration date: 27-MAY-2017. No adverse effects were reported. Additional information has been requested.
Booster dose was administered by error from expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster dose was administered by error from expired vial) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021 at 9:45 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster dose was administered by error from expired vial). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Booster dose was administered by error from expired vial) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was unknow if the patient was diagnosed with or tested positive for COVID-19. It was also unknown if she had any acute illness at the time of vaccination and up to one month before or any chronic or long-standing health conditions. It was also unknown if she had taken any prescription, over-the-counter medications, dietary supplement or herbal remedies at the time of vaccination.  It was stated that, she had come in to receive her Moderna booster dose and was by error administered a dose from expired vial. She did not have any adverse reaction that was noted. She was notified and told what happed. She was informed that team would be in touch with further instructions once a final decision was made on whether or not to redose, per the supervisors instructions.   No concomitant medication reported. No treatment information was reported.
Eight hours after receiving the vaccine, the patient reported extreme pain around the injection site; injection site red, circumference of 8 X 3 inches; on 3/12, patient reported mild pain; on 3/13 pt reported BP fluctuations between 133/72 and 185/84 over a 3 hour period; on 3/14, his BP fluctuated 133/72 - 176/84 over a 3 hour period. Patient reported feeling better on 3/15 and has an appointment with his physician tomorrow to possibly adjust his blood pressure medications.
pt was riding in car had sz, eyes rolled in back of head, apnea, jerking motion;went to hosp by amb incident occurred 8 days p/DTAP;low grade temp 100.5;
Hard swollen and hot area the size of an orange at the injection site.  Next day  Headache a couple of hours after receiving shot
This spontaneous report as received from a medical assistant refers to patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown dates, the patients were vaccinated with improperly stored ROTATEQ orally, L029617 exp. 19-MAY-2017 (dose and site of administration were not reported). There were no adverse effects reported. The temperature of the storage was 47 Fahrenheit degree for 135 minutes. There was no previous temperature excursion. The reporter was call because of a "data logger". No product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
very unusual, heavy vaginal bleeding that lasted through the day, overnight, and into sunday morning; This is a spontaneous report from a contactable consumer or other non-health care professional (patient).   A 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Batch/Lot Number: EW0175), via an unspecified route of administration, administered in right arm on 23Apr2021 at 17:00 (at the age of 34-year-old) as dose 2, single for COVID-19 immunization.The patient medical history was not reported. The patient had no allergy. 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. Concomitant medications included sertraline hydrochloride (ZOLOFT), estradiol (VIVELLE-DOT), guaifenesin and ibuprofen. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot Number: ER8730), via an unspecified route of administration, administered in right arm on 26Mar2021 at 12:30 as first dose for COVID-19 immunization. The patient experienced very unusual, heavy vaginal bleeding that lasted through the day, overnight, and into Sunday morning on 24Apr2021 at 09:00. Since the vaccination, the patient had not been tested for COVID. The patient visited to emergency room/department or urgent care. The patient did not receive any treatment as a result of event. The outcome of the event was resolving.  No follow-up attempts are needed. No further information is expected.
tingling in the tip of the tongue halfway; redness in face and forehead; This is a spontaneous report from a contactable consumer reporting for herself. A 58-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot number and expiration date were not reported) via an unspecified route of administration, administered in left arm on 26Feb2021 11:00 as SINGLE DOSE for COVID-19 immunization. The patient had known allergies (unspecified). Concomitant medication(s) included hydrocortisone cream; clobetasol cream 0.05 (unit not reported); and bacitracin zinc, neomycin sulfate, polymyxin B sulfate (NEOSPORIN). The patient did not receive any other vaccine in four weeks prior to COVID vaccination. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was reported that on 26Feb2021 11:00, the patient had tingling in the tip of the tongue halfway, redness in face and forehead. Therapeutic measures were taken as a result of event; treatment included Benadryl. The outcome of the events reported as Recovered with lasting effects (Recovered/Resolved with Sequel).  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
Narrative: Timing error, 2nd covid-19 Pfizer dose given too soon (12days) after first dose.
Shingles on the right side, near the breast; itching; This case was reported by a consumer and described the occurrence of shingles in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 4BA4A, expiry date 31st January 2022) for prophylaxis.   The patient's past medical history included shingles (eight separate occasions).   On 8th December 2020, the patient received the 1st dose of Shingrix (intramuscular). On 9th December 2020, 1 days after receiving Shingrix, the patient experienced shingles and pruritus. The patient was treated with benadryl (nos) (Benadryl) and hydrocortisone. On an unknown date, the outcome of the shingles and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the shingles and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right arm. After receiving Shingrix, the patient experienced shingles on the right side, near the breast and itching.   The patient was using Benadryl and 1 percent hydrocortisone cream to help alleviate symptoms.  The reporter consented to follow up.
Employee had a flu vaccine at our staff clinic and the next day woke up with axillary swelling. Employee has had multiple vaccines and never had this reaction until he received the COVID-19 vaccine by Moderna and he had swelling with both his COVID vaccines and now is having this reaction with the Influenza vaccine and has never had a problem in the past. Employee still has swelling and iced it but only for a minimal time. He said he would ice it more tonight.
Vaccine given at 10:23am. 10:27am 10/10 sharp lower back pain. 10:32am 4/10 lower back pain felt like needles in lower back. No swelling. No rash. Slight tenderness with palpation. 10:43am 1/10 lower back pain. 10:52am no lower back pain. Lungs clear. 11:08am No lower back pain. Lungs clear. Per Dr.
W/in 4 hours of shot she stated she was feeling dizzy. She was also not able to eat for the next 12+ hours because of stomach pains. She additionally was noted staring off in a daze and also would stop walking midway and just stare.
rt deltoid hematoma w/nausea & h/a;s/p vaccination hep B dose 3
This spontaneous report was received from a physician via a company representative and refers to a male patient in his 60's. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On an unspecified date in 2014, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# and expiration date were not reported). On an unknown date (reported as "within a few weeks of receiving ZOSTAVAX"), the patient developed an inflammation of the eye that affected his vision. The patient visited an unspecified ophthalmologist (on an unspecified date) and was diagnosed with an "inflammatory process of the optic nerve." The patient was given an unspecified antiviral medication as a treatment for the event. The outcome of the inflammatory process of the optic nerve and relatedness between the event and ZOSTAVAX were not reported. Additional information has been requested.
Severe chills for 1.5 hr despite multiple heated blankets, comforter, etc.; high fever, severe headache (pain in ears and eyes as well as head), severe muscle and joint pain body-wide, skin painful to touch. Symptoms so severe that sleep was impossible for most of night. Headache severity lessened by 8a.m. 3/20, but is still present, and widespread joint pain, myalgia and fatigue continue up to the time of this report (24 hrs after injection).
body pain; fever; headache; fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body pain), PYREXIA (fever), HEADACHE (headache) and FATIGUE (fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced MYALGIA (body pain), PYREXIA (fever), HEADACHE (headache) and FATIGUE (fatigue). At the time of the report, MYALGIA (body pain), PYREXIA (fever), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Folllow-up information received on 26-JUL-2021 contains non significant information.
On 10/21/04: had synagist fluzone and MMR. On 10/28/04:had temp 104 and seizure x 5 min. Went to ER: final diagnosis from ER was viral syndrome and febrile seizure. On 11/24/04:came to office for more shots and mother  told us had been to ER.
This spontaneous report was received from medical assistant regarding multiple unspecified patients of unknown age and gender. The medical history of patients, concurrent conditions and their concomitant medications were not reported. On unspecified dates, multiple unspecified patients were vaccinated with improperly stored doses of RECOMBIVAX HIB lot, dosing details unknown. No adverse effects were reported. Product quality complaint  (PQC) was not filed. This is one of the four reports received from the same reporter. Additional information has been requested.
She experienced a slight redness on her arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (She experienced a slight redness on her arm) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Medical history also included adverse reaction with shingles.  Previously administered products included for Product used for unknown indication: Flu shot (She did not had events with the Flu shot), Penicillin and Cipro. Past adverse reactions to the above products included Adverse event NOS with Cipro and Penicillin; and No adverse event with Flu shot. Concurrent medical conditions included Penicillin allergy.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (She experienced a slight redness on her arm). At the time of the report, ERYTHEMA (She experienced a slight redness on her arm) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Patient mentioned that it was not the first time she experienced as she "had it with the shingles, the cipro and penicillin" but not with the flu shot. Patient believed she had a problem with the binder. No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2022-533436, MOD-2022-533363 (Patient Link).
Child woke up for the day and said his leg was itching, upon inspection, it was red, swollen, and hot. As the day progressed, the red area became larger and felt sore.  Child reported feeling nauseous throughout the day as well.
Symptoms 18May then positive AG 19May; Symptoms 18May then positive AG 19May; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 47-year-old male patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EL3247), on 23Mar2021 as dose 2, single (Lot number: EL3247) and on 23Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 46 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 19May2022, outcome "unknown" and all described as "Symptoms 18May then positive AG 19May". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19May2022) Positive, notes: Test type: Unknown. It was unknown if therapeutic measures were taken as a result of covid-19, vaccination failure.  Clinical Course: The patient was administered with the most recent COVID-19 vaccine at (Facility) Workplace clinic. It was unknown whether the patient receive any other vaccines within 4 weeks prior to the COVID vaccine and prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments:  Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events vaccination failure and Covid 19  cannot be completely excluded.
Late Saturday (02/06/2021) night /early Sunday (02/07/2021) morning I noticed a lump on my chest near my left collar bone (received both doses in my left arm). It is noticeably sore and tender to touch
Swollen, red left arm. Red streaks run down arm to chest. Feeling "congestion" in her chest.
This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer reporting for herself. A 70 (unspecified unit) female patient of unspecified race/ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced vaccination site pain for days after and painful red arm both on an unspecified date with outcome of unknown.
Patient fainted within 5 minutes of administration. She came to very quickly and felt nauseous. We monitored and had her drink water. Advised mother to call PCP on Monday
contracted covid-19 after her booster shot.; contracted covid-19 after her booster shot.; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 29 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "contracted covid-19 after her booster shot.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: contracted covid-19. Patient had no covid prior vaccination and she tested positive post vaccination.  No follow-up attempts are possible. No further information is expected.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; SINUS PRESSURE; This solicited report received from a patient: concerned a 40 year old female of unspecified race and ethnic origin. The patient's height and weight were not reported. The patient received flu vaccine around October 2021. It was unknown if the patient had any drug abuse or illicit drug usage, consumed alcohol or smoked. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered in MAY-2021 for prophylactic vaccination. Dose number in series 1. The batch number was not reported and has been requested. No concomitant medications were reported. The patient was negative a week ago and went into quarantine. She was residing in a 2-bedroom apartment with 3 other gentlemen from a neighboring shelter who all tested positive. Only the gentleman she roomed with had complete Moderna vaccine (Moderna) and booster and still tested positive. On 27-NOV-2021 (Saturday night), she had chills and fever which subsided by Sunday (28-NOV-2021). On 28-NOV-2021 (Sunday night), she started getting sinus pressure. On 29-NOV-2021 (Monday), she experienced drainage and cough. On 30-NOV-2021 (Tuesday), she lost smell and tested positive (confirmed covid-19 infection and confirmed clinical vaccination failure). She mentioned that she was fully functional and felt like it was a very minor sniffle cold. Laboratory data included: COVID-19 virus test (NR: not provided) positive.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection, confirmed clinical vaccination failure and sinus pressure was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and confirmed clinical vaccination failure, confirmed covid-19 infection, and sinus pressure was not related. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000205012.; Sender's Comments: V0: 20211203852- covid-19 vaccine ad26.cov2.s- confirmed clinical vaccination failure. This event(s) is considered not related. 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