chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare worker refers to a number of unspecified patients (demographics unknown). Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patients were vaccinated with GARDASIL (dose and lot number were not repotted). Concomitant therapy were not reported. From approximately October 2013 through December 2013, the patient may have received GARDASIL whose temperatures were not monitored in a refrigerator. The reporter did not know the temperatures the vaccines were exposed to during this period of time or if any excursions occurred. GARDASIL was not supported due to lack of temperature data. No adverse symptoms were reported. This case is linked to the same source (MARRS# 1401USA004015 and 1401USA005012). Additional information has been requested.
started getting 'chills' about 9 hrs after injection (8pm), then proceeded to get violent chills, fever, and nauseau until about 4am the following morning.  the following day was still minor nauseau and tired from prior evening of not sleeping.  Injection sight felt like a bruise, but very tolerable.  Did not feel 'normal' again until >48 hrs after injection.
Itching and diffuse rash. Symptoms developed within the hour and resolved within the next 6 hrs. I also had numbness on my right arm where the injection was placed for about an hour.
Patient was vaccinated for COVID-19 on 4/8/2021 and 4/29/2021. Patient was fully vaccinated when tested positive for COVID-19 on 10/11/2021.
Asked patient to stay 30 minutes post vaccine for observation. At 10 minutes after vaccine she notified RN that she was having chest pain. The pain increased and she was administered Epinephrine 0.3ml. FiO2 per mask given. No loss of consciousness,. Medical response team notified. Transferred to ED. O2 sat 100% and Systolic BP 146 at time of transfer.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. In JAN-2021, the patient was in hospital for seven days for an unspecified reason.  The patient received initial vaccination with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) on an unspecified date in MAR-2021 for prophylactic vaccination.  Following administration of covid-19 vaccine ad26.cov2.s, it was unknown whether patient had any adverse events. The patient received booster vaccination with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) on an unspecified date in NOV-2021 for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date in JAN-2022, the patient tested positive for COVID-19 and was sick for more than a month (confirmed covid-19 infection and confirmed clinical vaccination failure) (dose number in series 2). The patient was also afraid to go out and be around any close relatives or friends (dose number in series was 2). The patient had never gone out without a mask, was very careful and washed hands more than often. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with a product quality complaint (PQC) number: 90000215107.; Sender's Comments: V0- 20220201023-Covid-19 vaccine ad26.CoV-2.s- Suspected clinical vaccination failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS
Hospitalization: 2/8/2023 - 2/10/2023 (2 days) Presentation to the ED: altered mental status associated with facial drooping and difficulty speech COVID + date: 2/8/23 Treatment: supplemental oxygen Discharge to: home.  002A21A 2/24/2021 017B21A 3/29/2021 032H21A 12/30/2021 045J21A 6/16/2022
Mother reports evening 3/05/09 Pt developed swelling and redness at L thigh.
received IPOL on 3/27/09 and developed hives within 24 hrs
punctured the vials 21 times yesterday and gave that dose to a patient; punctured the vials 21 times yesterday and gave that dose to a patient; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (punctured the vials 21 times yesterday and gave that dose to a patient) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (punctured the vials 21 times yesterday and gave that dose to a patient) 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 15-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Dec-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (punctured the vials 21 times yesterday and gave that dose to a patient) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (punctured the vials 21 times yesterday and gave that dose to a patient). On 15-Dec-2021, PRODUCT ADMINISTRATION ERROR (punctured the vials 21 times yesterday and gave that dose to a patient) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (punctured the vials 21 times yesterday and gave that dose to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.
PATIENT HAD INJECTION SITE REACTION WITH LARGE RED CIRCLE THAT SEEMED TO MOVE FROM DELTOID TO DIFFERENT POSITION ON ARM FROM INJECTION SITE.
Staff member stated that the patient drove there for treatment that a rash that developed, but was not sure if it was from her anxiety or the vaccine itself. They administered decadron and diphenhydramine.
Patient presented with increased Dyspnea, orthopnea, pnd. She had a cough which was dry and non productive. In the ER she was covid 19 positive. Pt was thought to be in heart failure excacerbation and also had a covid pneumonia. Pt was started on IV diuretics, steroids, vitamins. She was out of the window for remdesvir.  Cardiology was consulted. CT PE was negative for PE.  Pt was diuresed and felt much better. Pt's kidney function and electrolytes were better. Patient was discharged home.
Pt called on 6/3/21 to say he is still having arm pain.  He still feels a hard knot at the injection site.  He also described gradual decrease in range of motion of the arm.  Patient also stated that he has had a headache almost every day since the vaccine.
After immunization, pt got up & walked away from pharmacy. A minute later, pt collapsed with clenching teeth, seizure like reaction. Ambulance was called & pt was transported to hospital. Pt was released same day. Attempted to contact pt for follow up but no answer from pt.
Tinnitus beginning a few days after second shot .  Waxed and wanes in severity, but constant to this day
same day of vax pt exp swelling & redness, size of baseball for 6 hours. treatment cool packs & tylenol
This non-serious initial spontaneous case received on 11-Oct-2017, was reported by a pharmacist concerning a 70-year-old elderly, adult male patient. The patient's medical history was not reported. The patient's concomitant medications were CRESTOR and aspirin taken for unknown indication. On 09-Oct-2017 the patient received FLUAD (TIV) (dose: 0.5ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 178301, expiry date: Apr-2018). On the same day after vaccination, the patient experienced redness and felt hot at the injection site. At the time of this report, the patient was feeling better. The outcome of the event injection site redness and injection site warmth was recovering. The reporter assessed the events as non-serious. Follow-up received on 20-Oct-2017: The outcome of the events was changed from not reported to recovering and the batch number of the suspect vaccine was added in the screen. The narrative was amended accordingly.
sicker; Initial information was received on 01-Oct-2021 regarding an unsolicited valid non-serious case received from, consumer/non-healthcare professional via social media (under reference number US-SA-SAC20211004001058)  This case involves 90 years elderly patient (unknown gender) who experienced sicker (Illness), after receiving vaccine INFLUENZA VACCINE..  The patient's past vaccination(s) included INFLUENZA VACCINE at 76 years.  The patient's past medical history, medical treatment(s), concomitant medication(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 and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sicker (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  No additional laboratory data was reported.  It was not reported if the patient received a corrective treatment for the event (sicker).  At time of reporting, outcome of the events was unknown.  There will be no information available on batch number for this case.
fever 100-101 began 7FEB; rash on upper arms & thigh 9FEB; intense diffuse morbilliform rash on face, trunk, extremities on 10FEB93;
#2 Rabavert on 5/13/10 at approx 8:30 AM-reports by 8:00pm-c/o severe muscle and joint pain. Symptoms lasting until 5/16/10. Denies any reaction at injection site. Stated with #1 injection on 5/6/10 had an episode of dizziness lasting only 5-10 and minutes and was not reported.
One week later I had heart and breathing problems. My vascular health got worst . I have a inmune desease that the havent diagnose yet. Id became anemic
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX (dose, frequency and route of administration were not provided) lot# N017700 and expiration date: 09-JUN-2019. The VARIVAX was reconstituted with properly stored dose of sterile diluent (manufacturer unknown). No adverse effect was reported. The vaccine was stored in between 15 degrees Fahrenheit (F) to 46F for 1 hour and 9 minutes. Previous temperatures excursions were in between 6F 14F for 76 minutes and in between 15F to 46F for 1 hour and 23 minutes. The digital data logger was involved in recording the temperature excursion. Sender's Comments: US-009507513-1711USA002012.
Sore arm 3 days, Sleepless night 04/30, extreme fatigue, no appetite 24 hours, Flu like feeling
SEIZURE LIKE ACTIVITY STARTING APPROXIMATELY 24 HOURS AFTER VACCINE ADMINISTRATION 7/20/2009.  DENIES ANY PROBLEMS YESTERDAY. VOMITED ONE TIME. THIS MORNING BODY BECAME STIFF. 10/19/09 Emergency Room records received for date of service 7/2/09.  Dx:  Otitis media. Assessment:  Presents with low grade fever and nasal congestion. Middle ear infection diagnosed, amoxicilliin prescribed.    10/19/09 & 10/20/09  Hospital record  and discharge summary received for date of service 7/21/09.  Dx:  Prolonged seizure at least 1 hour long s/p immunization, hypoxemia, severe globally developmental delayed child.   Assessment:  Seizure started at 10:00 or 10:30 arrived at ED at 12:00, given 1 dose of diazepam with mild resolution. Had vomiting earlier in the day. Later another seizure developed and a second dose of diazepam was given.  Pulse ox was 89%, given oxygen by NC, increased O2 sat. to 98%.  Phenobarbital level was 16 (low side of normal), Phenobarbital dose increased while in hospital.  Discharged seizure free x 24 hours.  Pt. to be followed up in 1 week by PCP and 2-3 weeks by neurologist.  ICD-9 Codes:  780.39  10/20/09 ER records received service date 9/29/09. Assessment: Recurrent Status Epilepticus. Viral Syndrome. Febrile Convulsions. Patient had vomiting prior to generalized tonic clonic and local motor seizure. Weight loss, cough, nausea, diarrhea, dyspnea on exertion.
Got sick with Covid on 2/24/2023.  Did have a positive PCR test. I got over this in about a week. Then in April 2023, became sick and was diagnosed with Long Covid.
Pt reported tingling & mild numbness from injection site to elbow on 06Jan.  Pt reported hives in a 2-3 inch diameter w/ 3-4 plaques stemming from injection site.  Pt reported mild DOE on 05Jan that has resolved.  Pt denies any other type of reaction.
pt recvd vax & exp abcess of Lt thigh; thigh turned hard over week; skin became redder & pt very irritable 48 hrs prior to admission; tx w/ ATB;
Pt recvd vax & exp achy @ inject site & weakness (heaviness) upper arms;blisters in mouth on rt side, ache behind rt eye, sense of taste altered;11JAN93 fever, rigors (cold chills), nasal congestion, sinus congestion, tightness & hoarseness
bad headache; arm discomfort; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (bad headache) and LIMB DISCOMFORT (arm discomfort) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (bad headache) and LIMB DISCOMFORT (arm discomfort). At the time of the report, HEADACHE (bad headache) and LIMB DISCOMFORT (arm discomfort) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No corrective treatment and concomitant medication was reported. Consent given for Safety Division to follow up with her if needed.
The patient visit was scheduled for a 2 mos well child check. The immunizations were pre-ordered and the order set was created for a 2 month old patient instead of a 1 mos old patient. Patient received PENTACEL, Rotavirus, and PREVNAR at age 5 weeks instead of receiving the Hep B vaccine. The event was then reported to the physician.
pt recvd vax 29JUL93 & later in evening seen in ER for light-headed feeling; blood glucose level low=30; given orange juice; sent home;
STARTING ON 3-7-2020 PT STARTED HAVING HER MUSCLES NOT REACTING TO HER MOVEMENTS. PT WAS TAKING IBUPROFEN TO HELP WITH MUSCLE ISSUES.  ON 3-16-20 PT WENT TO MD AND WAS DIAGNOSED MYOSITIS.  SHE WAS PUT ON 2 WEEKS OF PREDNISONE AND HAD NO RELIEF.  PT HAD A TELEVIST WITH MD ON 3-30-20 AND WAS PUT ON 20MG PREDNISONE FOR 1 WEEK, THEN DECREASED TO 10MG. PT IS CURRENTLY ON 5MG PREDNISONE.  PT WAS FINALLY ABLE TO WALK ABOUT A WEEK AGO.  DURING THE PREVIOUS TIME THE PT COULD NOT WALK WITHOUT BEING ASSISTED BY HER HUSBAND.  PT FELT REALLY SICK AND TIRED DURING THIS PERIOD. SHE IS CURRENTLY  DOING STRETCHES TO BE ABLE TO WALK FAR DISTANCES.  HER LEGS ARE BETTER BUT HER ARMS/SHOULDERS ARE STILL IN PAIN
would like to speak to someone regarding side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (would like to speak to someone regarding side effects) 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 No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ADVERSE DRUG REACTION (would like to speak to someone regarding side effects). At the time of the report, ADVERSE DRUG REACTION (would like to speak to someone regarding side effects) outcome was unknown. Not Provided
Client received the vaccination around 10:00 am and around 10:06 am felt chest tightness and it was hard to breathe. She described it as not being able to get a full breath. She drank water, leaned back, and took deep breaths. After about 5 minutes, client felt better. Client left at 10:31 am with symptoms completely resolved.
Pain at the injection site; Rash; Fever; Nausea; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 9AB33, expiry date 6th February 2021) for prophylaxis.   On 12th September 2019, the patient received the 1st dose of Shingrix. On 12th September 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, rash, fever and nausea. On an unknown date, the outcome of the injection site pain, rash, fever and nausea were recovered/resolved.   It was unknown if the reporter considered the injection site pain, rash, fever and nausea to be related to Shingrix.  Additional case details were reported as follows: The health care professional reported pain at the injection site, rash fever, nausea and said the symptoms last over 7 days and wanted to know if the patient should receive the second dose. The reporter consented to follow up.
Palpitations. Pain at vaccine site, left upper arm. Extreme pain on left arm from vaccine site to elbow, left scapula, left side of neck and ear; extreme headache originating on left side of head. Extreme pain on both legs causing walking difficulties. Generalized malaise, nausea, lack of appetite, and extremely tired.
C/O redness, swollen arm at site, itchy - treatment - ice to site and Benadryl if needed per MD.
Pt rec'd measles immunization in left arm on 2/17/05. Arm became red, edematous, painful. Progressed to neuralgia. Pt returned to clinic on 3/7/05. Pt was sent to ER. Pt stated she had reaction x1 week prior to office visit which was reported-therefore onset approx 3/1/05, but states is unclear of actual onset of symptoms.  Pt stated that she noticed something wrong right after the shot which was received on 2/17/05.
Patient presents to the ED with fever and began feeling ill today (11/5/2021).  Reports chills, also.
My menstrual cycle was delayed by 3 months.  My last menstrual period was June 28 to July 5 2021, and then I had no signs of a period until October 17th.  I had multiple pregnancy tests and all were negative.  I also was off Birth Control for this entire time.  I had a telehealth appointment with my Doctor on Sept 16th.  She indicated that I should wait a little longer to see if my period came on its own.  She also ordered blood tests to run another pregnancy test, as well as check for hormone levels or any other abnormalities.  I had blood drawn on 9/20.  Everything came back normal and negative for pregnancy.   My period finally arrived on its own on Oct 17th.  I read that there was some data potentially linking menstrual cycle disruptions to the COVID shot and so I thought this was a health event worthy of reporting.
Previously exposed at work to COVID patient; tested rapid test NEG, PCR test POS; no referee assay ordered/completed by hospital consult.  Told test "NEG" with likely false POS.  Advised to receive VX as it's work required.  Pt vaccinated on AUG 09, 2021; first/only dose with Jansen product. By DAY-00 post VX noticed mild reactogenecity Sxs of malaise, fatigue.  On Day-10 post VX, Sxs progressed from mild to severe with myalgias, fatigue & generalized malaise.  Unable to manage all ADL, unable to attend work. By definition CTCAE v.5.1, GR3. By Day 11/12, loss of taste & smell began with with cough & mild SOB.  Today, Day16 post Dx, remains ill. Unclear path of events un-dx'd COVID vs. IRIS + con't viral shed.
Patient complained of GERD going from her epigastric area through to her back. Vital signs monitored. Symptoms resulolved within a few minutes. Pt states that she had not eaten lunch and this was not an uncommon thing for her to experience  GERD,  but had never experienced with vaccination. Monitored patient for 30 minutes post vaccination. Telephoned patient at home at 1822. She is feeling well with no further issues.
patient lost concoiusness briefly.  he said it happens with vaccines.  he had also not eaten all morning.
Following injection with ZOSTAVAX I developed a pain and swelling on one side just under my skull and down my neck, and other side same spot had 2 shingles-like blisters that are taking a very long time to heal.
Started on 11/14 with feet tingling. Has progressed to need for ventillator support. Family questions flu or pneumovax vaccination. Consultation report DX: GUILLIAN-BARRE syndrome Respiratory failure urinary tract infection Encephalopathy Hypertension Questionable history of deep venous thrombosis History of hiatal hernia/dyspepsia Dyslipidemia. One week prior to admission in usual state of health developed severe pain in bottom of her feet up into pelvic bone. Negative CT scan. Increased pain in hands cannot life her arms. On admission tingling in feet. Tongue and lips numb.  11/21/06 pulmonary consult: now on day 4 0f 5 IV IG. Progressive respiratory decline, insufficiency with falling negative inspiratory force. HTN.   DC with instruction to take motrin, FLEXERIL and PERCOCET. and 11/18/06 DX numbness in hands/arms. weakness. DC home. Discharged to rehab Facility. Off ventilator and had finger flexion and other movement.
Ringing in ears sometimes louder in the left ear -vaccine in left arm; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 05Apr2021 at 14:15 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. On 09Apr2021 at 16:00, the patient experienced ringing in ears sometimes louder in the left ear. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event and included ENT visit and hearing test was scheduled. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event ringing in ears sometimes louder in the left ear was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a health professional refers to an unspecified number of patients of unknown age. On 20-SEP-2013 the unspecified number of patients might be vaccinated with VAQTA (Lot#, dose and route not reported). The healthcare worker reported VAQTA were out of temperature range and were not supported by their in house stability data and an unspecified number of patients (no patient information known at that time) might have been administered the vaccines. No adverse effects were reported. No PQC (Product Quality Complaints) was involved. It was unspecified if the patients had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
C/o SOB. Stated she had similar symptoms when she had anaphylactic reaction to eggplant/legumes. Breath sounds clear, no wheeze, rhonchi. Given Benadryl 25mg PO. Epi-pen administered. 911 called. Ambulance to hospital.