chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Presented for respiratory distress, onset a few hours prior to arrival, hypertensive at 236/123 in the ED, appeared volume overloaded per ED physician note, was given 80 mg Lasix and nitroglycerin, and was placed on BIPAP. Despite this he continued to have respiratory distress and was intubated due to concern for impending respiratory arrest. Covid testing was positive. Patient admitted to the ICU for management. Initial Echo showed stress-induced (Takotsubo) cardiomyopathy, which eventually recovered. He had AKI. His Covid was treated with Decadron; he did not qualify for remdesivir or baricitinib due to requiring mechanical ventilation from the onset. His hospital course was complicated by bacteremia, pneumonia and renal failure. He required steadily increasing ventilator support, had to be deeply sedated and paralyzed. Despite maximal intervention, he continued to decline and family elected to enroll patient in hospice and pursue compassionate withdrawal of care. Patient discharged to inpatient hospice. Pt expired.
He got his vaccine, had flu like symptoms for the first 2 days, chills, muscle pain.  The 2nd or 3rd day was coughing and sneezing for 2-3 days.  The 5th day was severe diarrhea.  Then he started to feel better on the 6th day and then on the 7th day he felt fine and then on the 11th day the symptom started all over again, the exact same way and the symptoms continued in a cycle.  He then saw his PCP who started doing tests and have been doing testing since.    He asked him to prescribe him for inflammation/joint pain and he prescribed Ibuprofen for that.   His doctor did prescribe antibiotics thinking it was a bacterial infection, but the antibiotics didn't help and tested him again and it was negative.     He is now having coughing, sneezing, sinus but only for a few days and very mild and goes away, and then cycles back around again every couple of days.  It stopped being 7 days of flu about the 12th time and then stops for a few days and then continues.  He has weakness of his legs, cannot grasp things like a  gallon of milk is too heavy, has weakness and fatigue.   He feels as if his body has inflammation but his SED rate came back normal, and wonders what is going on and did not have any of this before the vaccine.    He did have a neck injury in the past, was jogging and getting back in health and loosing weight and since the vaccine has severe arthritis and is depressed and desperate and feels that he won't be here if there is no improvement.
On 3/10/2021 patient got dose 1, Pfizer, EN9581. On 4/1/2021 patient got dose 2, Pfizer ER 8733. I saw the patient in cardiology clinic on 12/2/2021, and noted the correlation of vaccination with myopericarditis within 30 days, so am filling out the report. Patient present to the Hospital on 4/27/2021 with chest pains.  Labs showed a rising troponin with peak troponin 5.1 ng/ml (not high sensitive, so this is significantly elevated, with normal <0.04), with cardiac cath and MRI and echo all done at the time.  Conclusion was probable viral myocarditis.  See cath and MRI results below.  Tested pos for mononucleosis (also pos for this in 3/2020 though so may have been prior infection) and neg for other respiratory viruses including COVID and flu in 4/2021.  Of note, did see rheumatology in 2019 for knee pains and had labs to assess for for autoimmune disease here (ANA, ENA, complement levels, RF) and all were normal.
pt recv vax 21JUL97 & several days later pt had prolonged episode of fever which ended 27JUL97
Fainting and seizure. Patient felt light headed and kept in room for about 15-20 minutes. I gave her water and offered to call 911. Guardian stated that he was going to take her to "get checked out." I do not know if he was going to the ER or just urgent care.
Patient experienced syncope episode : turned pale, fainted and fell off the chair, leg jerked. Had to call 911
Pfizer vaccine was requested by patient and administered by staff before confirming first dose on patient vaccination card. Patient had received the first dose with Moderna vaccine.
Vaccinee rec'd series of 3 Hepatitis B vax according to 0, 1, 6 mo scehdule. Arthralgia started JUL89 p/2nd dose & required orthopedic & rheumatology consultations; condition persisted;
patient fully immunized (Pfizer, 9/18/2020, 10/9/2020).  developed symptoms on 07/17/2021
No adverse effect; multiple unspecified patient have received improperly stored vaccines; This spontaneous report as received from a medical assistant refers to a patient of unspecified age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided.  On 15-MAY-2019, the patient received improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (0.5 ml, one dose; lot# N028744, expiration date: 11-MAR-2020; route of administration was not provided US-009507513-). No adverse effects were reported. Hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was stored in refrigerator and experienced temperature excursion of 28.2 degrees Fahrenheit (F) (1 cycle) for 19 hours. There was no previous temperature excursion. Digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA008229: US-009507513-1909USA008228: US-009507513-1909USA005979: US-009507513-1909USA008227:
Bilateral knee joint pain, fatigue, insomnia and back pain started the next day after vaccination. (10/4/17).
Immediately after injection, baby cried, and then had uncontrollable screeming for 4 hours.
Patient reports blood in urine on 02/07/2023 (4 days after vaccination with shingles vaccine). Patient indicates blood in urine is being managed by provider as UTI
pt fell in the doorway as pt was leaving immun room;non-responsive to verbal stimuli for several seconds;was taken to hosp by mom;
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Additional Details: Pt experienced throat closing and itching about 40 minutes after receiving second covid vaccine, took benadryl and went to bed. Pt still had symptoms the next morning, called MD, and took higher strength of benadryl and symptoms resolved.
received VARIVAX during Temp Excursion; No additional AE; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On an unknown date, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (single dose, lot#: W031815, expiration date: 05-OCT-2024; strength, and route of administration were not reported) for prophylaxis. The vaccine administered experienced temperature excursion before (product storage error). No additional adverse events (AE) (no adverse event).  This case was received from the same reporter with the case 2307USA009505 and 2307USA009506.
Patient complained of pain and soreness. When daughter checked it next day saw redness under the site of injection that has still not resolved after almost 72 hours.
When I caught COVID I was down for at least 10 days. I had a bad cough, and I had a fever 101.0. The first day I didn't feel good, and I tested myself and I was negative. When I tested again the next day, I was positive. I called my doctor, and they proscribe me Paxlovid.
Information has been received from a licensed practical nurse concerning a patient who on approximately Nov 05 2004 (over the last week) was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 648139/0009P). Subsequently, the patient developed a local site reaction to include pain at the injection site, erythema, swelling, induration, local heat and malaise. the patient sought unspecified medical attention. it was also reported that the patient was treated with antibiotics and was recovering. There was no product quality complaint involved. It was also reported that five other patients experienced adverse events following administration of pneumococcal 23v polysaccharide vaccine (lot 648139/0009P) (WAES0411USA02321). Additional information has been requested.
I had fatigue and fever for 5 days. I had chest and nasal congestive, coughing, headache, body aches, and sore throat.  I am past the 14 day, I still have the congestive, fatigue and cough.  I went on Jan 8th, and was tested positive for Covid-19.
A non-serious, spontaneous report of administration or expired product was received from a nurse concerning a 36 year-old female subsequent to FLUMIST. On 03-Feb02009, the patient received expired FLUMIST (expiration date 09-Jan-2009). There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Additional information was received on 17-Feb-2009 and incorporated into the narrative: no events reported since vaccination. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product form the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product  expired. Additional information was received on 09-Apr-2009 that included the results of investigation for medication error.
Syncope; This is a spontaneous report from a contactable physician via Pfizer sales representative.  A male patient of an unspecified age (reported as 18, unit unknown) received a single dose of meningococcal group b rlp2086 (TRUMENBA) and meningococcal vaccine conjugate (MVC4) both on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The nurse gave to the patient the vaccines and on an unspecified date after vaccinations, patient had syncope. The outcome of the event was unknown. Information on the batch number has been requested.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Alongside headache and fatigue, I experienced notably increased heart rate. I have chronic tachycardia, likely [non-covid-related] POTS (and several medications that worsen this as a side effect), but I take Metoprolol to treat this. As a result, I typically have an HR of 80-95 when sitting at rest. On the 16th, it was 120-140+ when sitting/laying at rest. After my first appointment of the day, I had to drop the rest of my plans to rest, and I slept about 16 hours. This also happened after the second dose, but I was unsure if it was related to the vaccine, as I had made several errors with my daily medications that week and had gotten little sleep. This was not the case after third dose, yet the symptoms were worse. After 16 hours of sleep, the symptoms largely subsided, and if boosters were to be offered annually going forward, I would continue to take them despite these symptoms, but the effect on my HR was arguably substantive, so I figured I should report. *I also had soreness at the injection site, which was mild and expected. I also had swelling of my lymph nodes on the left side only, at the base of my neck. I've never had this reaction to a vaccine before, including previous doses of this vaccine (all Moderna), and I've never had swelling this extreme from an active infection either.
Information has been received from a consumer concerning her daughter who on approximately 21-AUG-2007, was vaccinated with a first dose of Gardasil.  On approximately 21-AUG-2007, the patient developed a rash on her torso.  At the time of this report, the patient's outcome was unknown.  No further information is available.
Fever of a 102 on day 14. Patient continued with 101 degrees F on day 15 post vaccination.  Fever continued thru 4-10-2003 with GI upset.  Returned to work on 4-11-2003 improved afebrile.  Saw PMD on 4-9-03 adn sent home.
BOTH INJECTION SITES BECAME BRUISED, THERE WAS A RED SWOLLEN 5 INCH DIAMETER BAND BELOW INJECTION SITE AND THE BAND WAS FEVERISH.
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Moderna product on 12/30/2020 and 01/26/2021. They tested positive for COVID-19 on 09/30/2021. They were admitted to hospital on 10/01/2021. Primary complaint was assessment after a fall. The individual was a resident of an assisted living facility. The individual was described as being asymptomatic. However, the individual died on 10/11/2021. COVID-19 is listed on the death certificate.
Feeling that part of her arm was numb in that she could not feel it.  Started at the site of the vaccine and then extended to elbow initially.  Repeat eval with exam on 10/11 showed progrssion of the numbness distally.  She had no proprioception, light touch or vibratory sense throughout every dermatome of hte left arm.
A non-serious report of "we gave a partial (1/2) of H1N1 Vaccine to 5" was received from a physician concerning a 44-month-old male. The patient's medical history was not provided. On 20-Oct-2009, the patient was inadvertently administered half of H1N1 dose. There was no adverse event associated with this administration error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Patient presents with a potential reaction to the COVID-19 Vaccine. The patient was seen on the ground between his car and the bathroom in the monitoring lot. He was responsive and reported that he passed out while walking to the bathroom. He also reports that this has happened in the past. In a review of records, he had a similar episode in 2019 which resulted in a facial fracture repaired surgically. He did not have a head strike this time and his fall was supported. He felt well rapidly and was given oral hydration. VS WNL  Patient with a GLF from vasovagal syncope. No injuries were sustained and he returned to baseline with oral hydration. He was returned home with his wife as the driver.
flare of psoriasis; her legs where the psoriasis was is still inflamed; flare of psoriatic arthritis; worse after getting the vaccine; This is a spontaneous report from a contactable consumer or other non healthcare professional.   A 50-year-old female patient received first dose of bnt162b2 (BNT162B2, Batch/Lot Number: EN6205), via an unspecified route of administration on 25Feb2021 (at the age of 49-year-old), as DOSE 1, SINGLE, and received second dose bnt162b2 (BNT162B2, Batch/Lot Number: EP7534), via an unspecified route of administration on 16Mar2021 (at the age of 49-year-old), as DOSE 2, SIN-GLE both for Covid-19 immunization. Medical history included psoriatic arthropathy from an un-known date and unknown if ongoing, She just has been diagnosed with it but has had probably 4 years. It was diagnosed 3 or 4 months ago, psoriasis from an unknown date and unknown if ongoing Had psoriasis prior to getting the vaccine and has had for around 47 years, asthma from an un-known date and unknown if ongoing. Concomitant medications included over the counter cetiriz-ine hydrochloride (ZYRTEC, CETIRIZINE HYDROCHLORIDE) taken for an unspecified indication, start and stop date were not reported, and she just takes an inhaler (unspecified) for asthma. She states within a week or two of taking the vaccine, it started after the first vaccine, and if she could re-member correctly when but it also got increasingly worse since. On an unspecified date, the patient experienced flare of psoriasis, her legs where the psoriasis was still inflamed, flare of psoriatic arthritis, worse after getting the vaccine as the condition aggravated. Therapeutic measures were taken as a result of flare of psoriasis with Cimzia 400mg twice a month, she said normally the bio-logic would work relatively quickly for her and it had worked in some areas but there is some areas where it has been untouched, and areas seem untouched. Duobrii 100 gram tube for 30 days. she got her prescription for 3100 g tubes for 30 days. She states that her legs where the psoriasis was still inflamed after over a month of being on this medication. The other areas did clear up completely. She adds that she was not sure the timeline of when she started these two medications as mentioned for treatment. She started them before the vaccine if she remembers correctly and then at the same time as the vaccine, she dropped down to a maintenance dose of the medication and it flared up. Then, it was boosted back up to the initial dose and now she was on the initial dose and it was not helping. They have cleared up a lot, just not completely gone. The outcome of the events of flare of psoriasis, flare of psoriatic arthritis and worse after getting the vaccine was unknown. The outcome of the event of her legs where the psoriasis was is still inflamed was re-ported as not resolved.    Follow-up attempts were completed. No further information was expected.
COVID positive on 2/2/2021  1st covid vaccine given on 12/28/2020 2nd covid vaccine given on 1/19/2021
Anxious,/jittery  reports allergy to lubricating jelly Generalized body and worsening hives with itching VSS Observation, water, Benadryl 50 mg po  at 12:08 pm  Picked up by mother and taken home 12:50 pm
1 person to die from the vaccine; This is a spontaneous report from a Pfizer-sponsored program. This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  It was reported that 1 person to die from the vaccine on an unspecified date. The patient died on an unspecified date.  It was not reported if an autopsy was performed. The reporter reported his views about the vaccine. The event was assessed as serious(fatal).   The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.  Follow-up activities closed. Batch/lot number not available for vaccine/BNT162B2; Reported Cause(s) of Death: 1 person to die from the vaccine
Individual little pink dots at Injection site; Injection site Red; Hurt for 2 days/felt pain in right arm; Swelling around the site of injection; Dots around the site of injection; Injection site  Warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Dots around the site of injection), VACCINATION SITE WARMTH (Injection site  Warm), VACCINATION SITE DISCOLOURATION (Individual little pink dots at Injection site), VACCINATION SITE PAIN (Hurt for 2 days/felt pain in right arm) and VACCINATION SITE SWELLING (Swelling around the site of injection) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2020, the patient experienced VACCINATION SITE WARMTH (Injection site  Warm). On 29-Dec-2020, the patient experienced VACCINATION SITE REACTION (Dots around the site of injection), VACCINATION SITE PAIN (Hurt for 2 days/felt pain in right arm) and VACCINATION SITE SWELLING (Swelling around the site of injection). On 06-Jan-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Individual little pink dots at Injection site) and VACCINATION SITE ERYTHEMA (Injection site Red). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE REACTION (Dots around the site of injection), VACCINATION SITE WARMTH (Injection site  Warm), VACCINATION SITE DISCOLOURATION (Individual little pink dots at Injection site), VACCINATION SITE PAIN (Hurt for 2 days/felt pain in right arm), VACCINATION SITE SWELLING (Swelling around the site of injection) and VACCINATION SITE ERYTHEMA (Injection site Red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  The patient reported the events lasted for around 1 week.  Patient took ice as treatment.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-up received and event outcome updated.; Sender's Comments: This case concerns a 58-year-old female with a nonserious unexpected event of pain in extremity, vaccination site reaction, vaccination site warmth, vaccination site discoloration and expected vaccination site erythema and vaccination site swelling. Event onset the same day as first dose mRNA-1273. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report was received from a physician refers to a female patient of unknown age. On an unknown date in August 2013 (also reported as 8 months ago)the patient was vaccinated with first dose of GARDASIL (0.5 ml) intramuscular. The physician called the patient's mother to remind for the second dose of GARDASIL. The physician stated that the patient was out of the country at the time of second dose was due. On an unknown date, the patient experienced unspecified respiratory illness. The outcome of the event was unknown. The reporter did not provide the causality between the event and the suspect drug. This case is linked to case 1404USA013210 (same reporter link). Additional information has been requested.
Information has been received from a 25 year old white female consumer with a penicillin allergy who is a registered nurse.  The reporter indicated that on 12/17/2002, in the pm, she was drawing up a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) and may have gotten a little spray in her eye (dilutent lot # 643507/0669M).  She indicated that she was unsure and is not having any problems at this time.  Unspecified medical attention was sought.  Follow-up information from the consumer indicated that while mixing, she got spray in her eyes.  She rinsed her eyes at an eye wash station and no problems ensued.  There were no diagnostic studies or laboratory results.  Additional information has been received from the consumer, who is also a registered nurse, indicating that she did not have any more information, nor could she "provide a lot number."  Additional information is not expected.