chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt reported about 15 minutes after vaccine that she was experiencing tingling in tongue and roof of mouth. Pt was brought back to observation room and further assessed including VS q5minutes. VS remained stable. Pt reported a few minutes later that she felt the left side of her tongue was numb and possibly swelling. RRT was called at 1014 and arrived at 1020 and assessed patient. Offered ED, pt declined, then it was recommended that she stay another 30 minutes for observation. Pt agreed. VS continued, pt states she feels as though the symptoms are resolving. Called RRT after 30 minutes and they recommended she go home but call PCP to make f/u appt and continue to monitor throughout the day. If symptoms worsening or swelling/SOB occurs, go to ED. Pt verbalized understanding and was escorted out with her husband.
Symptoms of post herpetic neuralgia over the R occipital distribution similar to a previous herpes zoster irruption. There were no obvious lesions but my scalp felt as if there was localized swelling.  The symptoms are persisting three weeks after onset but are not severe. The symptoms began approximately 3-4 weeks following the immunization and after the initial symptoms of arm pain, myalgias and fatigue resolved.
Patient came into clinic for a second Varivax vaccine, but was given the wrong vaccine which was Shingrix.
Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 3:30 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 3:30 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 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 47.62   No concomitant medications were reported.  Batch number 044B21A underwent temperature excursion on 15-Apr-2021 with temperature 34 degrees Fahrenheit from 9 AM. This vial was moved to fridge on 06-Apr-2021 and beyond use date for the vial was reported as 09-May-2021. Product moved to clinic on 15-Apr-2021.  Vial was stored in cooler 1, on 15-Apr-2021, temperature excursion at 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 PM: 39, 1PM: 43, 2 PM: 44 and 3 PM: 44.  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.   This case was linked to MOD-2022-566976 (Patient Link).
After I sat down in the injection room, the pharmacist prepped my skin with an alcohol pad. Upon the pharmacist inserting the needle I looked away. When he stuck me I felt as if it was too high, I looked & he verbalized that he was meeting resistance when trying to administer the vaccine. It did not feel like it normally did when I received vaccinations, it felt as if the needle was deeper.  Almost like it was in the joint. He withdrew the needle & then proceeded to stick me about 1/4 of an inch down with the same needle & I could tell they he pushed past some resistance to administer the vaccine. At that point I knew he had given  the injection too high.  He stuck me right beneath my acromion process. As soon as he pushed the medication in I felt a ?swoosh? & immediate pain which is unlike anything I have felt when getting a vaccination. Since receiving the vaccination I have had pain everyday. The pain is exacerbated by lifting my arm & it worsens at night. I receive a flu vaccine every year & never have more than some slight soreness for a day or 2 after. I am going to give it a few more days before I seek medical attention.
Patient called and reported redness, swelling, and shortness of breath today. Instructed to go to the ER for evaluation and tx. Seen in ER, discharged at 13:48 on 7/13/16.
The pt developed fever approximately 4-5 hrs post vaccination which it reached 106 deg F druing that night per parents. No vomiting, no syncope, some headache. The pt was seen the next day at the office and all the exams were normal.
This spontaneous report was received from a physician, via Novartis (company reference # PUS2016US093951), referring to a 70 year old female patient. The patient's medical history included pneumonia in February 2016. Concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the second dose of PNEUMOVAX 23 (dose, route and anatomical location were not reported) as indication of asthma and cardiac valve disease. On an unknown date, two days after vaccination, the patient experienced right side pneumonia and required hospitalization. The outcome of the event was unknown. The causality assessment between right side pneumonia and PNEUMOVAX 23 was not given. Upon internal review, right side pneumonia was determined to be medically significant. Additional information has been requested.
7mo following initiation of vax series, HBsAb was +; On 22FEB90, had a reddish patch w/skin changes suggestive of keratinization approx 1cm across @ site of inject;
Pt felt abd pain 10 mins p/inject became pale laid pt down BP 5 min later was nl 90/58, HR 96; pt improved, when leaving @ 12:40 became pale again-BP 90/50; gave 02;
When administering the Monkeypox Jynneos vaccine intradermally, RN had needle in pt.'s L forearm too superficially and most of vaccine leaked out.  Another RN then placed Monkeypox Jynneos vaccine 0.1ml intradermally to L forearm at least 2 inches away from original site.
Per pt, about 2-3 days after received, broke out in rash and bumps. On 11/8/16 pt came to pharmacy and pharmacist, myself instructed him to see MD, possible viral rash or allergy all over body. Saw his PCP 11/9 given Valacyclovir and prednisone. Once prednisone computed, returned again but worse. Required ER visit and repeat of prednisone and repeat visit to dermatologist 11/15/16.
Tachycardia, SOB and light-headedness with near syncope with exertion noted 04/21/2022. During visit with primary care on 06/23/2022, abn ECG noted. Follow up with cardiologist on 08/25/2022 with diagnosis of supraventricular tachycardia, atrial flutter, paroxysmal atrial fibrillation and possible Wolff Parkinson White syndrome and possible hypertrophic cardiomyopathy. Tests included 48-hour Holter monitor August 8-11, 2022; Transthoracic resting echocardiogram August 30, 2022; Exercise stress test 09/21/2022; cardiac MRI/MRA October 6, 2022. A catheter ablation procedure is scheduled on November 30, 2022.
Client stated that he has had a lump at his umbilicus for a long time. He started to have pain yesterday. The pain got worst s/p his vaccine and is reported as 10/10. EMS called, client taken to Hospital.
Received varivax 6/27/95-Developed mild case of Varicella 11/2/99.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 59-year-old male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because their facility was unable to download the digital data logger, they would need to treat the issue as a temperature excursion. The data logger that caller was unable to download were for the months of Dec-2021, Jan-2022, and Feb-2022. It was also reported that no adverse reactions were reported by patient.  No treatment information was provided.   This case was linked to MOD-2022-501575 (Patient Link).
I just had pain and swelling at the injection site that lasted over three days.  On the 7th Thursday night, I developed a fever 101.5 and took Friday the 8th off of work. I also got a Covid test that came back negative and saw my PCP also tested for Flu A and B, tested negative.  I felt lousy, has chills, aches, sinus head aches, I was miserable.  My fever went away the afternoon of the 8th and I did not have a fever after that.  On the 11th I saw my PCP and he referred me to an ENT and I saw the ENT on the 13th.  I also called off work 14th-29th. I was admitted at the Hospital on the 14th with a code and had two surgeries and Gallbladder removed.   I was in the Hospital for 5 days.    I had my 2nd shot on the 5th with approve from Medical Dr.s with a little swelling but no other symptoms.
had strong reactions causing arthritis flares after the second shot; had strong reactions causing arthritis flares after the second shot; This spontaneous case was reported by an other health care professional and describes the occurrence of ARTHRITIS (had strong reactions causing arthritis flares after the second shot) and VACCINATION COMPLICATION (had strong reactions causing arthritis flares after the second shot) in an adult 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received 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 ARTHRITIS (had strong reactions causing arthritis flares after the second shot) and VACCINATION COMPLICATION (had strong reactions causing arthritis flares after the second shot). At the time of the report, ARTHRITIS (had strong reactions causing arthritis flares after the second shot) and VACCINATION COMPLICATION (had strong reactions causing arthritis flares after the second shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided.  Treatment information was not provided.  This case concerns an adult female patient with no medical history, who experienced the unexpected serious adverse event of special interest, Arthritis. The event occurred on an unknown date after receiving an unspecified and undated dose of mRNA-1273 Vaccine. The rechallenge was not applicable since no information about the other dose was given. No clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.  The patient have had strong reactions to the vaccine causing arthritis flare.   This case was linked to MOD-2021-428572 (Patient Link).; Sender's Comments: This case concerns an adult female patient with no medical history, who experienced the unexpected serious adverse event of special interest, Arthritis. The event occurred on an unknown date after receiving an unspecified and undated dose of mRNA-1273 Vaccine. The rechallenge was not applicable since no information about the other dose was given. No clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Patient was not eligible to receive vaccine since she is 17 years old and 23 days shy of 18th birthday, but received vaccine anyway.
This spontaneous report as received from a healthcare worker refers to a 17 yeas old patient. The reporter stated that a shipment of GARDASIL that was shipped from company on 08-JAN-2014 was received at her facility on 13-JAN-2014. One dose of GARDASIL (lot # J012212 exp. date. 18-FEB-2016, dose, route and site of administration not reported) was administered to a patient on 13-JAN-2014 before the status of the shipment was realized. The healthcare worker did not believe that GARDASIL was exposed to temperatures out of the recommended range for longer than 72 hours. No adverse effect had been observed or reported. Additional information has been requested.
After 5 to 6 minutes receiving vaccine I was feeling dizziness, I was shaking, I have Hart punding and chills going to my right side of my face including jaw, cheek, eye and ear. I feel weakness.
Rash on left arm and abdomen (not site of vaccination). Four days later, rash on right arm, hip, and right inner thigh. Slight headache.
The left side of my mouth started visibly twitching and I was concerned I might be starting Bell's Palsy or something similar.  I had my husband look at it and he thought the same thing.  We researched the Pfizer Vaccine and discovered there were rare instances of Bell's Palsy during the trials for the vaccine.  We also found that tics of this nature are more common.  We waited a while and the symptom subsided and I went to bed.  When I woke up in the morning the twitching did not recur, but there is a heavy sort of feeling on the left side of my mouth.
High fever, seizure, rash tx w/TYLENOL. Suspect from MMR vaccine.
Systemic: Seizure-Severe, Additional Details: within 5 minutes after administration, he collapsed, lost conciousness and had a seizure which lasted 30-40 seconds.  we protected his head and laid him flat on ground and called 9-1-1. he maintained breathing and pulse throughout. when EMTs arrived he walked out with them for further evaluation.
CHEST TIGHTNESS; HAIR FALLING OUT ABOUT 3-4 WEEKS NONSTOP; PERIOD STOPPED FOR 4 MONTHS/AMENORRHEA; SHORTNESS OF BREATH/DIFFICULTY BREATHING; INVOLUNTARY WEIGHT LOSS; SICK FOR ABOUT A WEEK; HEADACHE/TOP OF HEAD SUPER TENDER; PAIN AT INJECTION SITE/RIGHT ARM HURT FOR ABOUT A WEEK A HALF; This spontaneous report received from a patient concerned a 39 year old female of unspecified race and ethnicity. The patient's weight was 118 pounds (135 pounds before vaccine), and height was 170 centimeters. The patient's concurrent conditions included: non smoker, non alcohol user, autistic spectrum (processing disorder), Ehlers-Danlos (connective tissue disorder),severe anxiety disorder, attention deficit hyperactivity disorder (ADHD),  complex post-traumatic stress disorder (CPTSD),  contrast dies allergy,  allergy to anti-depressants and allergy medication. Other pre-existing medical conditions included: Patient had no drug abuse or illicit drug use. The patient had a history of  vaccine reaction (" vaccine given in 1/4 doses"). The patient was planning to have genetic test for allergies and how medications react. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 12-APR-2021 in right arm for prophylactic vaccination. Concomitant medications included Xanax (alprazolam), marijuana (cannabis sativa) and ketamine for complex post-traumatic stress disorder. On an unspecified date, the patient experienced chest tightness, hair falling out about 3-4 weeks nonstop, period stopped for 4 months (amenorrhea) shortness of breath/difficulty breathing, weight loss, sick for about a week, headache/top of head super tender, and pain at injection site/right arm hurt for about a week a half (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest tightness, shortness of breath/difficulty breathing, sick for about a week, headache/top of head super tender, and pain at injection site/right arm hurt for about a week a half, had not recovered from hair falling out about 3-4 weeks nonstop, and involuntary weight loss. The outcome of period stopped for 4 months/amenorrhea was unknown. This report was non-serious. This case, involving the same patient is linked to 20211235188 (dose number in series 2).
arm was sore and had no bullseye in it but was red and a little swollen; arm was sore and had no bullseye in it but was red and a little swollen; arm was sore and had no bullseye in it but was red and a little swollen; Caller states she had the booster on Sunday; rash; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A female patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm on 03Oct2021 as dose 3 (booster), single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot Number: Not reported) as dose 1, single and second dose via an unspecified route of administration on an unspecified date (Batch/Lot Number: Not reported) as dose 2, single both for COVID-19 immunization. On 03Oct2021, patient experienced caller stated she had the booster. On 05Oct2021, patient experienced arm was sore and had no bullseye in it but was red and a little swollen. On Oct2021, patient experienced rash. It was reported that she was calling about her follow up visit to the doctor and they thought it was a rash she got from the booster shot that says it looks like it could be Lyme's. She stated she had the booster on Sunday and on Tuesday her arm was sore and had no bullseye in it but was red and a little swollen and very mild and was almost gone now; She asked if that was seen or was a normal type of thing at the injection site. Reporter stated she was read a whole big thing about the vaccine, and they put her on with another nurse and they said she would have to talk to another medical person to get an answer to her question; stated the reason she was reporting about her follow up visit to the doctor and they thought it was a rash she got from the booster shot that says it looks like it could be Lyme's. Adverse event rash resulted in physician office visit. The outcome of the event arm was sore and had no bullseye in it but was red and a little swollen was recovering and other event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Activation of SLE, Celiac, and Fibromyalgia Flare,  & Caused Rheumatoid Arthritis and Hemolytic anemia,  Created life threatening flare.  Widespread systemic inflammation, severe pain, depression, anxiety, loss of apatite, severe weight loss, left breast pain with inflammation with severe joint pain and fatigue.  Chronic headaches.  My eyebrows fell out, and I am still losing my head hair.  I am still in a shed and my hair on my head is thing and will not grow like it used too.
Initial information received from a consumer who is also the patient on 04 October 2012. An 81-year-old female patient, whose medical history and concomitant medication were not reported, had received intramuscular dose 2 FLUZONE HD (Lot number unknown) in left deltoid on 01 October 2012. On 01 October 2012 in evening, the patient experienced redness and itching at injection site after the vaccination. Next day she had red, rash, itching, swollen area from elbow to shoulder of left arm on which she had received her vaccination. Red, rash and itching were better and only swelling of elbow, like "fluid around elbow" was there. Laboratory details were not reported. Corrective treatment included "BENADRYL". The patient's outcome was not recovered. Documents held by sender: None.
I have had ringing in my right ear everyday and my right side of my ear is painful when I chew
Severe pain in both arms few hrs after injection given in left arm. Now, right arm swollen compared to left. Carpal tunnel pain at wrist. Worse at night and when holding arm in downward position. Have not had carpal tunnel before. No injury to arms. No recent trauma or heavy lifting
She developed a rash within 24 hours of the vaccination. Itchiness.  This continued for about 5 days. It was sporadic from chin and neck area to buttocks. Still some remaining patches and red welts on top of the skin.
About 3 hours later, I passed out.  My husband picked me up and laid me on the bed.  I had seizers that lasted for about an hour.  I went to the ER the next morning.  They did CT scan, blood work, EKG, and MRI.  My blood pressure was also evaluated.
My cycle went from 28 days for the last 14 years to now being 35 days apart.
Patient had appropriate first dose of pneumovax23 on 04/26/2016. Patient was incorrectly given a second dose of pneumovax23 on 02/02/2021. This was less than 5 years between doses and patient was not due again for another pneumonia vaccine until she is 35 years old. At this time patient reports no adverse events or symptoms. Instructed patient to contact primary care provider or myself with any new adverse events, symptoms, or concerns.
On 11/05/2001 the patient called to report her entire left arm is achy from the MMR vaccine. The Dr advised treatment of Tylenol and a warm compress. On 11/06/2001 the patient's pain was resolving but not enough to return to work.