chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu like symptoms; Difficulty breathing; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number GL2HR, expiry date 31st May 2021) for prophylaxis.   Concurrent medical conditions included attention deficit/hyperactivity disorder.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms and difficulty breathing. On an unknown date, the outcome of the influenza-like symptoms and difficulty breathing were unknown.   It was unknown if the reporter considered the influenza-like symptoms and difficulty breathing to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported, but it could be 70 or 71 years. The patient reported having flulike symptoms after first dose, as well as difficulty breathing. The reporter consent to follow up.
Numbness along the entire length of left arm, back of hand, shoulder (front & back), left side of neck (front, back & side), left side of face, left ear and left backside of head.  Noticed approximately 1 hour after injection and continues through this moment.
Within approximately 32 hours of receiving vaccine, began experiencing tinnitus in right ear.  Noise is described as a high pitched whine that does not stop.
ACUTE NON ST ELEVATION MI 7/28/2022 ACUTE RESPIRATORY FAILURE ACUTE PULMONARY EMBOLISM 7/28/2022 ACUTE RESPIRATORY FAILURE ACUTE RESPIRATORY FAILURE 7/28/2022 ACUTE RESPIRATORY FAILURE
The odd thing was red patchy swellings on my left calf, where I have varicose veins already.  It didn't hurt and I didn't notice it til after I showered that evening.  The other symptoms were expected:  an overall body flush without a true fever, achiness, eye and headaches, fatigue, geneally dragged out.  Like a mini version of COVID, really.  It took several days to resolve completely.  The bruising on my calf segued to more of a hives, then a dark bruising as if it had been bumped.
pt recv vax;devel fine rash on face & abd 8 days p/ vax given;resolved in 5-7 days;
After receiving the vaccine, the patient felt dizzy and shortly fainted. He was unresponsive for a short period of time and then woke up. He was feeling cold at the time he was responsive.
6/13 - arm very hot and red, pt crying all day. 6/14 - work up, still hot and red with rash almost to elbow (approx 4"). Doesn't think she had fever. Appt offered - "too far to come" may go to UC mom says its from the DTaP IZ.
I broke out, I was sweating; Terrible headache; Chills; My body hurt; This is a spontaneous report from a contactable consumer (patient).  A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EJ1685), via an unspecified route of administration on 29Dec2020 at SINGLE DOSE for COVID-19 immunization.  Medical history included seasonal allergy. Concomitant medication included cetirizine hydrochloride (ZYRTEC) for seasonal allergy. On 29Dec2020 (within a few minutes), she broke out and was sweating. She had sweat at her face and sweated in her clothes. The patient also have a terrible headache, her body hurt and have chills. The patient did not receive any treatment for the events and was going to ask if she can take diphenhydramine (BENADRYL) as she do not know what to do. She doesn't know if she can take medicine because it was terrible. Outcome of the events were unknown.
Post administration of second vaccine -MCV4, instructed client to reposition on examining table in a supine position with head elevated. As he was positioning himself, stated that began to feel nauseated and general appearance was pale and cold & clammy upon touch. Administered Oxygen at 2L via mask. BP: 112/68, R 14 non-labored, P: 67, Temp 98.8F, and O2 Sats 99%. Client remained conscious during the entire event. No other symptom expressed. Reassurance provided and
Erythema, swelling x 10 cm at area of injection 2 days after receiving injection. Prescribed BENADRYL 1 every 6 hours.
After receiving the booster, I came down positive with covid in Jan 2022.  I received the infusion. 36 hours later I felt much better.
My family members had tested Positive for Covid-19 and so I went and got tested. I notified my Pulmonologist that I had tested Positive for Covid-19. I got an antibody treatment that evening. I recently had been treated for Pneumonia and my breathing was bad anyway, so I did not notice it getting worse. I quarantined and I did not notice that my symptoms were worse. My lower back pain was a little worse than normal. I ruptured a tendon in my right hand about a week after the antibody treatment.
Chills, sweating, loss of appetite   Slept for about 10-11 hours cold sweats throughout out the night and lingering feeling afterwards
Pfizer-BioNTech COVID-19 Vaccine EUA:  Patient received Pfizer Vaccines on 1/26/2021 and 2/22/2021. Patient presented to ED on 07/12/2021 with SOB (starting 3 days ago), cough, and fever. Patient received remdesivir x 5 days and was dosed with actemra on 7/20. Patient also completed azithromycin x 5 days and cefepime x 7days. 7/22/21: Patient was intubated on 7/22/21, proned on 7/23/21, started on CRRT on 7/25/21. Pt declined and was found to have worsening hypercapnia and hypoxia despite full support. Patient expired 7/27/21.
Patient rec'd Janssen COVID-19 vaccine at 0912. Immediately started vomiting. Stated "arm burned all the way to her hand with injection". Reported felt dizzy, lightheaded, hot". BP 98/62. Assisted to cot and side-lying position. Continued to vomit/dry heave. At 0921, pt stated she was "really tired" and couldn't keep her eyes open. Able to answer questions, but not always able to finish sentence. EMS called. BP returned to normal limits within about 5-10 minutes. Patient contiued to dry heave and c/o feeling cold and nauseous, as well as "really tired" until EMS transported her. 4/8/2021: Nurse called patient. Patient stated she "feels foggy today". States her arm is "extremely sore".
Information regarding PREVNAR 13 was received from a nurse regarding a 2-year-old male patient who experienced low grade fever, pain at injection site and fussiness. At 2 years of age, the patient received a dose on 04-Aug-2010. In Aug-2010 after receiving a dose of PREVNAR 13, the patient experienced low grade fever, fussiness, and pain at injection site but there was no swelling. Treatment was not provided and the events were considered resolved the next day. No additional information was available at the time of this report.
DEATH.   (Toddler was napping in crib during day.  Parent found child in full arrest.  (Unclear if he'd be seizing prior.)  CPR/EMS achieved pulse with full interventions but pt was brain dead and life-support was withdrawn within 8 hours of resuscitation.
The day after the vaccines were administrated, 10/10/2018, she had fever and dizziness and bilateral lower extremity numbness where the patient states she could barely walk. She went to the emergency room and was admitted for a few hours for observation and was discharged same day. Patient is doing well today all symptoms resolved. Plan of care to hold second dose of HPV and order allergy testing for yeast.
heart rate got down to 30; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE DECREASED (heart rate got down to 30) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pacemaker insertion (cardiac).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE DECREASED (heart rate got down to 30). The patient was treated with Surgery (Cardiac pace-maker insertion) for Heart rate decreased. At the time of the report, HEART RATE DECREASED (heart rate got down to 30) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 30 abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
second shot made me sick; I had the flu plus my arm for it; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles, burning sensation, pain, pruritus and sleeplessness. Previously administered products included Shingrix with an associated reaction of illness (1st dose received on an unknown date, refer case US2023AMR101740).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: second shot made me sick) and influenza (Verbatim: I had the flu plus my arm for it). Rechallenge with Shingles vaccine was positive. The outcome of the sickness and influenza were not reported.   It was unknown if the reporter considered the sickness and influenza to be related to Shingles vaccine.     It was unknown if the company considered the sickness and influenza to be related to Shingles vaccine.   Additional Information: GSK receipt date: 22-JUL-2023 This case was reported by a patient via interactive digital media. The patient stated that he/she had shingles and it was no joke, the burning and the pain and itching were all at the same time which made it hard to sleep.  The patient stated that as soon as the shingles went away he/she got vaccinated.  The second shot made the patient sick like he/she had the flu plus his/her arm for it. The patient stated that but it was worth it because if you do not get vaccinated, even if you had Shingles, you can get it again. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR101740:same patient, 1st dose
I have a bumpy, red itchy rash on my arm and a lump/bump at injection site. It is warm to the touch
If a person tested positive for COVID and took the first Moderna vaccine before knowing they were positive. What should they do?; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (If a person tested positive for COVID and took the first Moderna vaccine before knowing they were positive. What should they do?) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (If a person tested positive for COVID and took the first Moderna vaccine before knowing they were positive. What should they do?). At the time of the report, COVID-19 (If a person tested positive for COVID and took the first Moderna vaccine before knowing they were positive. What should they do?) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  At the time of follow-up report, it was reported that the patient was fine.  Treatment information not provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Updated outcome of the event.
This is a 18 y.o. male who is generally healthy. He received a second dose of the SARS2-COV vaccine on 3/4. The following morning he felt feverish and achy with malaise. He stayed home, drank fluids and rested and felt well enough to come up to ski this weekend. During skiing he had some anterior chest pain, it resolved and he went about his day. Tonight at 2245 the pain became sharp and awakened him from sleep. He felt nauseated and clammy as well. Father brought him to the ER for evaluation. His emergency department evaluation showed ST elevations most notably in the inferior and lateral leads as well as in the lateral precordium.
Urinary tract infection; This spontaneous case was reported by an other health care professional and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (Urinary tract infection). At the time of the report, URINARY TRACT INFECTION (Urinary tract infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided.  No treatment medications provided.
Patient has not complained of any side effects or problems, but when we went to work on the billing for the patient, we discovered that she had already received the Pfizer bivalent booster on 11-07-2022 from another facility. We were advised to report the duplicate vaccine.
9/11/02 Mother brought child in with itching and rash on arms, legs, back, abdomen and face. States noticed rash at 05:30. Referred to MD and was advised no more Hepatitis B; Rx for steroid for allergic reaction.
high fever, horrible headache, chills, nausea.  ALternated tylenol and advil every 4 hrs, cold compress to the head.  Lasted from 10pm on 2/19 until the morning of 2/21.  The afternoon of 2/21, fever and headache returned, not as severe.
Injection given right deltoid. Pt tolerated procedure well. Pt came back to clinic the next day, Oct 19, 2005 with reaction to site where pneumovax given. She had a swollen indurated area on her deltoid which measured 4 x 6.5cm. Mildly tender to palpitation mildly erythematous. Advised to not have further pneumonia vaccines. Benadryl oral and hydrocortisone cream to area, as well as ice.
stroke; past the 28 days; A spontaneous report  was received from a Pharmacist, concerning a Male patient of unspecified age who received Moderna COVID-19 vaccine and experienced Stroke and Missed dose.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 26 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in an unknown arm for prophylaxis of COVID-19 infection.   On an unspecified date, the patient had experienced stroke. He is now past the 28 days (Missed dose). They would like to know if he can still get his second dose. Treatment information was not provided. The adverse event of stroke was assessed as medically significant.  Action taken with mRNA -1273 in response to the events was not reported.  Outcome of the event of stroke was not recovered. Outcome of the event of missed dose was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Full body rash, currently diagnosed as dermatitis. Has lasted for 4+ months. Itchy red bumps on skin
No Adverse affects either immediately or later when parents notified(9/20/2010). Given Influenza vaccination we had available (following info insert). Later in talking with supervisor, discovered this was not to be given due to thimerosal in the product.
03 EARTHWORM SIZE BLOOD CLOTS IN LUNGS; This spontaneous report received from a consumer via a company representative through social media concerned a female (consumer's friend) of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had never been sick her entire life. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 01 total was administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient had 03 earthworm size blood clots in lungs, which was removed on an unspecified date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 03 earthworm size blood clots in lungs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220217407-covid-19 vaccine ad26.cov2.s-   03 earthworm size blood clots in lungs. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
No adverse event; patient was administered a dose of improperly stored PROQUAD; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's drug reactions or allergies, medical history and concomitant medications were not reported.   On 28-AUG-2019, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S003863, expiration date 08-AUG-2020) (dose, route of administration were not reported) for prophylaxis. No adverse effects was reported. The vaccine underwent temperature excursion of -14 degree Celsius to -10 degree Celsius (also reported as "-14.4 C") for 18 minutes. There was no previous temperature excursion. Data logger was involved. No product quality complains involved. No further information provided.
Fatigue, HA, pain at site (3-4 out of 10), muscle aches, flank pain  bilat (tender to touch)
?COVID Arm? - Vaccine sight area left arm began to itch, slightly tender, became a red blotch 2 x 4 inches
12 hours after vaccine given experienced severe headache which lasted throughout the week. Had 3 Urgent Care visits anf one ER visit, Saw her eye Dr and her PCP. Diagnosed with severe hypertension and vasculitis.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A male patient received bnt162b2 (BNT162B2), administration date 21Sep2021 (Lot number: 3013084) 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 2), for COVID-19 immunization, reaction(s): "uncomfortable", "threw him off for like a half day", "he got sick", "fever of 101 F."; Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization. The following information was reported: PANCREATIC DISORDER (hospitalization), outcome "recovered", described as "Pancreas "shut down"; BLOOD GLUCOSE INCREASED (medically significant), outcome "unknown", described as "Covid Booster Shot, third shot: blood sugar was 390/increase in blood sugar levels"; GLYCOSYLATED HAEMOGLOBIN INCREASED (non-serious), outcome "unknown", described as "Covid Booster Shot, third shot: A1C was 8.8/A1C was at 6"; ILLNESS (non-serious), outcome "unknown", described as "sick"; PYREXIA (non-serious), outcome "unknown", described as "fever of 101 F."; DISCOMFORT (non-serious), outcome "unknown", described as "discomfort". The events "pancreas "shut down", "Covid booster shot, third shot: blood sugar was 390/increase in blood sugar levels", "Covid booster shot, third shot: a1c was 8.8/a1c was at 6", "sick", "fever of 101" and "discomfort" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood glucose: 140; 390, notes: Two and a half weeks later; around 100-120 on average; increase; blood test: pancreas seems to be working correctly again, notes: but it had shut down; body temperature: 101; glycosylated haemoglobin: 6; 8.8, notes: Two and a half weeks later; 5.7; around 6. Therapeutic measures were taken as a result of pancreatic disorder, blood glucose increased, glycosylated haemoglobin increased. He went to his cardiologist and had bloodwork done which showed his blood sugar was 140 and his A1C was at 6. Two and a half weeks later he went to his primary care physician and had a blood sugar was 140 and his A1C was at 6 there, which showed his blood sugar was 390 and A1C was 8.8. His pancreas basically shut down so he went to the hospital overnight. The patient was put on 30 units of insulin plus metformin. He stayed on that for several months, really watched his diet and got his A1C back down to 5.7. So then was put on JANUVIA and metformin. He just stopped taking JANUVIA. His blood sugar was still around 100-120 on average and his A1C was around 6. He was scheduled for another blood test. His pancreas seemed to be working correctly again but it had shut down. His concern was regarding getting another COVID Booster Shot. He has an endocrinologist who said in the community there was some talk of blood sugar raising and these events. The patient's doctor was more perplexed at how the blood sugar and A1C could spike like that in 2.5 week period. No follow-up attempts are possible. No further information is expected.
Tingling and burning on 4-17-2021, on upper lefthand side of back. Burning, stinging pain on 4-18/2021 and 4/19/2021, same area. Rash broke out and it was diagnosed as shingles on 4-20-2021.
Painful injection; 1/2cc of the medicine splashed out from the syringe / the day after / no / soreness / as if I did not get any of the vaccine at all; Medicine splashed out from the syringe / landed on my right palm if the hand; Medicine splashed out from the syringe / landed on my right palm if the hand; This case was reported by a physician via call center representative and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 20th June 2021, the patient received the 2nd dose of Shingrix. On 20th June 2021, immediately after receiving Shingrix, the patient experienced pain, accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the pain, accidental underdose, exposure via skin contact and inadvertent exposure to vaccine were unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided are as follows: The age at vaccination was not applicable. The pharmacist had air in the syringe and upon the painful injection into my left upper arm, 1/2cc of the medicine splashed out from the syringe and landed on my right palm if the hand which led  accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. The day after, there was no indication or soreness in my left upper arm like  usually get it as if did not get any of the vaccine at all. The reporter enquired that if there was an antibody titer that could be checked and at what time to affirm whether patient did or did not received the vaccine and how soon and when patient could this 2nd dose that he/she supposed to receive to be fully vaccinated. The reporter would think patient was referencing a potential replacement/repeat dose.