chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt mild fatigue evening of vaccination. Day 2 reddish goose egg surrounded by slightly swollen upper arm at injection site. Sore to touch but otherwise non eventful. Lasted approx 3-4 days.   Day 8, noticed a mild itch at injection site and pink smaller sized raised area with non-painful swelling in upper arm.  Day 9, a bit more red and very mild itch sensation along left forearm. No rash, no big deal.
PATIENT HAS SLIGHT REDNESS AT INJECTION SITE AS WELL AS PALPABLE KNOT AND WARMTH IN THE AREA - PATIENT CONCERNED AND WANTS TO REPORT BECAUSE REACTION HAS PERSISTED FOR FOUR DAYS POST VACCINATION
Patient was admitted for acute CVA, hyperglycemia, and mild thrombocytopenia. Patient was treated and discharged on appropriate medications
This is a 72-year-old male with past medical history of former tobacco use, COPD, chronic respiratory failure (previously required home oxygen, currently cannot afford), hypertension, hyperlipidemia, PAD s/p aortoiliac stent/graft 2013, depression, prediabetes (A1c 6.0), who presents emergency department with progressive shortness of breath, cough for 1 week.  Patient reports his symptom onset was past Sunday, started with chest congestion, increased cough, shortness of breath, worse with exertion, generalized malaise, body aches.  Had intermittent diarrhea, denies nausea vomiting.  Denies chest pain, lightheadedness, dizziness, bleeding issues, fever.   Upon arrival patient was satting between 85 to 87% room air, p  Upon arrival patient was satting between 85 to 87% room air, placed on 2 L nasal cannula oxygen with improvement.  Received azithromycin, Solu-Medrol, bronchodilators, CTA showed no acute cardiopulmonary disease, did show advanced upper lobe predominant emphysema with 1.7 cm linear density within the right upper lung apex possibly scarring.  He is otherwise nontoxic-appearing, CODE STATUS discussed full code.   Clinical Summary Patient was admitted with above noted complaints.  He was continued on supplemental oxygen as needed.  He was started on Zithromax IV, remdesivir which was initiated with loading dose, bronchodilators, and Decadron IV for treatment of COVID-19 and COPD exacerbation.  Patient has had significant improvement in symptoms and has remained hemodynamically stable.  He has received a total of 4 doses of IV remdesivir and Decadron. He intermittently requires supplemental oxygen at rest therefore 6-minute walk test was completed which showed that oxygen saturation dropped to 87% on room air with activity.  Patient will be discharged with oxygen at 2 L via nasal cannula.  Patient has no concerns regarding discharge home today.  Prescriptions provided for dexamethasone and Zithromax p.o. to complete course.  Patient to follow-up with PCP in 3 to 5 days and also strongly encouraged to return to the ER if he develops any new or worsening symptoms. Discharge diagnosis Acute Hypoxic Respiratory Failure Acute COPD Exacerbation Acute COVID-19 Infection   Chronic conditions include: Hypertension Hyperlipidemia PVD s/p aortoiliac stent Former tobacco use Prediabetes (A1c 6.0)
I had a lot of pain in my shoulder. This happens in the morning around 8AM. I can't exercise because it would make my head hurt worse. I tried to take TYLENOL for the pain, and it wouldn't make a dent in the pain. I also tried to take a shower to get the pain go away that didn't work. The doctor said it was an onset rheumatoid. The doctor can see the swelling on my knees and wrist. The doctor could see how much pain I was in due to swelling. I also had a bad stomachache.
The pt experienced redness which was 2 inches in diameter around the injection site with limited amount of swelling. Suggested using Advil for inflammation and using ice and cold packs for 24 hours. Was seen in ER on 1/17
Patient vaccinated at 0845, observed for 15 min, tolerated well, no problems or concerns at that time, returned to  work.  Patient stated she had right chest tightness and "just didnt feel right" after vaccine, reported around 1445. shivering, and cold hands, verbalized weakness.   VS monitored for 30 min, WNL.  Oral benadryl given, EMS called, EKG completed, NSR, patient refused to be transferred to ER, stated symptoms subsisted after benadry.
Had Varivax 4/23/96. Had mild case of chicken pox diagnosed 10/30/03.
Mom reports that soon after vaccine was given, pt had redness of injection site starting. No worse than initially and no interference with activity. Still ambulating well. Office visit on 2/7/01, mom reports no increase in redness but questionable increased edema. Area with 2" X 1 1/2" of erythema, edema and hot to touch. Bears weight. Treat with Tylenol prn and cool compresses. Will monitor for worsening.
I had flu like symtoms for 2 Days. Left shoulder pain began. Unable to crank car window. Dr XRay and said Rotator Cuff ok - pain persists unable to life arm normaly
5 minutes after administering vaccines, the patient became limp and pale while mom was holding him. He did not stop breathing. I got his pediatrician and had the office manager call EMS. While taking his vitals he woke up, color came back to his face, and he began crying. His vitals were normal. He seemed lethargic, but eyes were open, and he was conscious. He is non-verbal so did not respond verbally to us. EMS arrived and patient and his mom were transported to the hospital.
2 weeks later had gotten pneumonia; 2 weeks later had gotten pneumonia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (174934). The reporter is the patient.  A 71 year-old female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20) (Batch/Lot number: unknown) as dose number unknown, 20 mg single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), PNEUMONIA (medically significant), outcome "unknown" and all described as "2 weeks later had gotten pneumonia".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Rash on arm after 2nd dose; This is a spontaneous report from a contactable consumer (Patient herself). A 43-year-old non pregnant female patient received bnt162b2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Em9810), dose 2 via an unspecified route of administration, administered in Arm Left on 05Feb2021 as dose 2, single (at the age of 43-year-old) for COVID-19 immunisation. The patient received first dose of bnt162b2 on 14Jan2021 at 02.00 PM (lot number El3249, Administration date 14Jan2021 at 02:00 PM, administered in right arm) (at the age of 43-year-old) for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included Pituitary tumor, diabetes and known allergies from an unknown date and unknown if ongoing. The patient did not have covid prior vaccination. Concomitant medications included in two weeks semaglutide (OZEMPIC) and sitagliptin phosphate (JANUVIA). The patient did not receive any other vaccine in four weeks. The patient experienced rash on arm after 2nd dose on 12Feb2021. The events resulted in physician office visit. The patient not tested for covid post vaccination. Therapeutic measures were taken as a result of rash on arm after 2nd dose and treatment included with Benadryl, cortisone cream. The outcome of event reported as recovered on an unknown date of 2021.  No follow-up attempts are possible. No further information is expected.
The resident was administered his second COVID vaccine (Moderna) on 5/19/21 at 9:30am. Per nursing, the resident tolerated the vaccine well and no problems were documented throughout the day. At 10:00pm the nurse who administered the vaccine recorded the resident's vitals as follows: BP 118/68, HR 72, Respiration 18, Temperature 97.0 F. At 10:20am the resident's CNA discovered him lifeless with vomitus around his mouth and neck. The resident was not breathing, bluish in color, and cool to the touch. Vital signs were checked and no pulse was detected. CPR was attempted with not effect.
pt was very anxious and claimed to have a scratchy throat, pt took zyrtec and felt better soon afterwards. Follow up with patient several hours later she claimed she was better.
about 5-10 minutes after vaccine developed mildly swollen tongue with 4-5 hives on tongue, never any resp. issues and was given 25 mg Benadryl, declined medical treatment
(I received Moderna COVID-19 Vaccine EUA.)      About 4 days after my Covid vaccination (April 24, 2021),  my right leg & buttock  began to tingle & burn. I started feeling lethargic & developed a rash - which worsened. On May 3, 2021, I went to Urgent Care & was diagnosed with Shingles.  I am still suffering with this condition.
Subsequent to receiving vax, the pt developed a flaky red rash on his face and arms.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021 at 12:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Mar-2021 at 12:00 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 67.94. No concomitant medications were reported.  Batch number 014M20A administered on 02-Mar-2021 underwent temperature excursion with temperature range of 33-36 degrees Fahrenheit from 12:00 PM to 01:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 02-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.
Patient developed significant chest pain It did not require additional medical care or impede breathing  However, pain was significant and unusual
A non-serious spontaneous report of sick, temperature of 102 F, headache, fatigue, decreased appetite and body aches has been received from a consumer/parent concerning his five-year-old daughter, subsequent to H1N1, Intranasal vaccination. Neither relevant medical history nor concomitant medication have been reported. On 07-Nov-2009, the patient received H1N1, Intranasal for an unknown indication. On 09-Nov-2009 and 10-Nov-2009, the patient experienced reactions to vaccine and developed symptoms of fever of 102 F, headache, fatigue, decreased appetite and body aches. The patient took ibuprofen and symptoms resolved by 11-Nov-2009. The outcome of reported events was resolved.
Patient presented to the hospital for evaluation of confusion, increasing tremors, loss of appetite, and fatigue. Patient tested positive for Covid-19, diagnosed with Covid-19 pneumonia. Patient was not a candidate for Remdesivir since her GFR is less than 30. Patient was on oxygen and was able to wean off to room air. Patient was discharged to SNU.
Puffy both eyelids and double vision.; Puffy both eyelids and double vision.; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER- BIONTECH COVID 19, Lot Number: EN6205), via an unspecified route of administration, administered in left arm on 16Mar2021 13:00 (at the age of 61-year-old) as single dose for COVID-19 immunization. The patient is not pregnant. Medical history was none. No known allergies. Concomitant medications included metformin; levothyroxine sodium (SYNTHROID); atorvastatin (LIPITOR) and women one day sl.  No other vaccine in four weeks. On 17Mar2021 02:00 AM, the patient experienced puffy both eyelids and double vision. No Covid prior vaccination and not tested with Covid post vaccination. No treatment was received for the events. The outcome of the events was not recovered.
Patient's left shoulder was sore right away and then progressed to nerve pain from the neck to shoulder on his left side.  He did not seek medical attention for this problem  and still has severe pain.  Palpitations started after the vaccination, but patient was unsure of exact date.  The palpitations worsened along with a jittery feeling, so the patient went to his primary care physician on 1/13/22 and then to ER.  He was diagnosed with Atrial Fibrillation and is being treated with medication by a cardilogist.
Administrated / Shingrix / on July 9 2021 / batch recall date: February 10th, 2021; Administrated / Shingrix / on July 9 2021 / batch recall date: February 10th, 2021; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 9LH3Y, expiry date 7th February 2022) for prophylaxis.   On 9th July 2021, the patient received Shingrix. On 9th July 2021, unknown after receiving Shingrix, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details were provided as follows: Health care professional reported that the patient was administered with recalled Shingrix vaccine lot, which led to recalled drug administered and drug dispensing error. The Shingrix batch was recalled on 10th February 2021. No adverse event was reported. The reporter consented to follow up. This is 1 of the 6 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021169129:Same reporter. US-GLAXOSMITHKLINE-US2021169132:Same reporter. US-GLAXOSMITHKLINE-US2021169133:Same reporter. US-GLAXOSMITHKLINE-US2021169134:Same reporter. US-GLAXOSMITHKLINE-US2021169135:Same reporter.
Started as a small rash couple spots on my forearm as the days and week went by it continued to get worse until I have a full body itchy red painful blistering rash all over my body two weeks and 3 days later it is still getting worse. 8 days I went to the urgent care that gave me prednisone. I have taken a 5 day round of prednisone and it did nothing
Death Narrative:  Death on 03/07/2021. 2nd dose administered 6 days before serious event. No data about cause of death available. Pt was dx Iron deficiency anemia and had been scheduled to have a diagnostic colonoscopy. No indication that death was related to the vaccine.
She had a cough that was a week long; she has stuffy nose and mucus she sounded congested.
I naturally  have heart palpitation like maybe 2 episodes  a week. I noticed it started to increase more and more.   They are benign for the most part. It was a Friday night 2 weeks  after the vaccine and the palpitations were not stopping. That Monday I called the cardiologist, Doctor said it was probably  from vaccine. He did  a work up and  listened to my heart, he did an EKG,  checked blood pressure . As I got further and further from the vaccine date, the palpitation episodes started getting further and further apart.  The doctor did say most people who had the vaccination were having similar symptoms. The palpitations were started getting further and further out and they eventually went away. It took weeks for it to go back to normal. No treatment was needed.
Chills, severe muscle aches, joint pains. Bone pain, specifically right tibia, left radius, right clavicle, right wrist
Itchiness on face. Capsule benadryl 50mg given. BP: 144/96 HR: 74 O2: 98%  -Patient had anaphylactic reaction from shingles vaccine(october2021). No any adverse reations from pfizer covid 1st and 2nd shot. -Patient feels itchiness on face after booster shot, no any difficulty in breathing. -Cap. Benadryl 50mg given, seems effective. -Adviced patient to go to ER for further education. Patient refused to go with clinics protocol, stated she will go by herself to ER accompanied with son.
headache, tiredness, sore, nausea. Cramps "like period but not period cramps" swollen lymphnode, wrist and hand pain (nerve pain)
RACING HEAT,  REOCURRANCE OF A-FIB.  HAD A CARDIOVERSION BUT DIDN'T WORK.  NOW NEED ABLATION.   ALSO HAD  STROKE SYMPTOMS 2 DAYS LATER AND CALLED 911.  THEY WENT AWAY.  NOW SHORTNESS OF BREATH, EXHAUSTION AN FAST HEATBEAT.
developed case of shingles; This case was reported by a nurse via sales rep and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th May 2020, the patient received the 1st dose of Shingrix .5 ml. On 23rd May 2020, 5 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   The reporter considered the shingles to be possibly related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and developed case of shingles. The reporter thinks the shingles could be result of vaccination.
Swelling in the left underarm area, along the rib cage. The area is roughly 10cm in diameter, and 2-3cm deep in the middle. It is easily compressed and is not sensitive to touch.; Dose received: 3; This is a spontaneous report from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in left arm, administration date 07Dec2021 at 13:45 (Lot number: EW0196) at the age of 57 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot Number: EL3247, Route of administration: Intramuscular), administration date: 16Mar2021, when the patient was 56 years old, and Bnt162b2 (DOSE 1, SINGLE, Lot Number: EL3247), administration date: 23Feb2021, when the patient was 56 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021 at 13:45, outcome "unknown", described as "Dose received: 3"; SWELLING (non-serious) with onset 08Dec2021, outcome "not recovered", described as "Swelling in the left underarm area, along the rib cage. The area is roughly 10cm in diameter, and 2-3cm deep in the middle. It is easily compressed and is not sensitive to touch". Therapeutic measures were not taken as a result of swelling.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Fever 100.5, body aches, headache, lethargy. Sore arm.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: other medical history: Asthma. The patient took concomitant medications. Past drug history included: Cefdinir, reaction(s): "known allergies: Cefdinir", notes: known allergies: Cefdinir. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Lightheaded, nauseous, extreme pain in right arm. Low grade fever, body aches, diarrhea, Headache, feeling faint. loss of sense of taste. A little swelling at injection site.
shingles after having received 2 shots shingrix/Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and teriflunomide (Aubagio) for multiple sclerosis.   Concurrent medical conditions included multiple sclerosis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In January 2021, the patient started Aubagio (oral) 14 mg once daily (14 mg daily). On an unknown date, unknown after receiving Shingrix and Shingrix and an unknown time after starting Valtrex, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). Aubagio was continued with no change. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 25-May-2022 Reporter's Comments: The patient's past medical history, medical treatments, concomitant medications and family history were not provided. In January 2021, the patient started taking AUBAGIO (TERIFLUNOMIDE) 14 mg QD (once daily) oral (with an unknown batch number and formulation, strength- 14mg) for Multiple sclerosis. On an unknown date, the patient started taking SHINGRIX vaccination. The reporter stated that the patient came down with shingles even after having received the 2 shots of the shingrix vaccination while being treated with TERIFLUNOMIDE (AUBAGIO). The patient advised to reached out to doctor office to make aware. The patient advised was prescribed a topical cream to help and valtrex and was recovering and advised to follow up with doctor to ensure aware and to see if any additional steps need to be taken. Additional Supportive Information: This case considered as suspected vaccination failure since the details regarding time to onset of shingles and laboratory confirmation of shingles were not provided