chrisvoncsefalvay/vaers-outcomes huggingface dataset:
passed out; the patient was told that she had a neural disease. She thinks it was multiple sclerosis; very sick; not good at taking care of herself; This spontaneous report was received from the patient's sister who is currently a 31-years-old female patient. The patient's pertinent medical history included miscarriage. The patient's current conditions included neurological diseases and reproductive issues. Drug/allergies were reported as yeast allergy that ran in the family. Concomitant medications were unknown by the reporter.  On an unknown date, also reported as at approximately age 18, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (dose, vaccination scheme frequency, route and anatomical location of administration, lot number, and expiration date were not reported) with indication reported as "vaccine" (prophylaxis). The reporter was not certain if it was quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) but stated that it was "the first one that came out".  On an unknown date, also reported as "sometime after receiving the vaccine", the patient became very sick (illness) and passed out (loss of consciousness). The patient went to the emergency room (ER) and she was told that it was due to a reaction of the quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) shot. On an unknown date, noted as "later", the patient was told that she had a neural disease and the reporter thought it was multiple sclerosis. The reporter stated that there was a lot of information that she did not know because her sister was not good at taking care of herself (Impaired self-care) and following up with her physicians about her health. The patient sough medical attention. It was unknown by the reporter if any treatment was given for the events, if laboratory diagnostics or studies were performed and no product quality complaint was reported. The outcome of the events was not provided.  The causal relationship between quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) and the events was not reported.  Upon internal review, the events passed out and multiple sclerosis were determined to be medically significant.  This is one of several reports for the same patient.; Sender's Comments:  US-009507513-2107USA006556: US-009507513-2107USA006557:
inject site swelled larger than fifty cents piece, very red & hot to touch; also entire leg all the way to groin turned blue, very tender to touch, lasted approx 1 month;
this person requested a home visit and lived in an independent facility. Per he was due for this second dose. when the Rn arrived she had also reviewed system and confirmed he was due for his second dose of moderna. she brought 0.5ml and spoke with the gentleman. he was adamant he was due for his booster dose. he noted he had  been given a    vaccine second dose while hospitalized. he did not have his vaccine card abut was very clear that if it was not noted in system it was an omission in recording. The RN proceeded to only administer 0.25mg which is the booster dose.  The following day while double checking system it was questioned why only 0.25 was administered. The nurse explained the gap in recording. the team did more review and reached out to the hospital who reviewed their system. They noted that no Covid vaccine was given but another vaccine was given  while in the hospital.   we consulted the CDC website for guidance. Since this was noted not on the same clinical day as the second dose the recommendation was to repeat a full second dose. The RN attempted to reach the person but was unable. she finally made a stop at his residence and administered as recommended by the CDC a full 0.5mg of Moderna on March 1,2022. it was all recorded in system. Nurse observed patient for thirty minutes and gave him proper instructions.  All of this was done with his approval
mom called stating pt cried constantly w/only brief mins frequently for over 4hrs; cry was described as high pitched in volume, non consolable; elevated temp 100.8 x 24hrs despite APAP; MD ruled a rxn
In 15 minute observation area, Passed out, fell off chair, had some shaking,  difficult to rouse, hit head on floor and got a small cut, was taken on stretcher to private area, vitals taken every 10 minutes, released in 30 minutes.  He still feels off, several hours later. Incident wasn?t documented at site.
Information has been received from medical assistant, concerning a 5 year old patient of an unknown gender. The patient's medical history, previously drug reactions, allergies, concurrent conditions and concomitant medications were not reported. On 26-OCT-2017, the patient was vaccinated with the first dose of PROQUAD subcutaneously, lot number N028445 with expiration date on 09-APR-2019 (strength, anatomical location and albumin status were not provided), reconstituted with DILUENT MRK 1 DF once, lot number: M035268 with expiration date on 19-APR-2019 (strength and anatomical location were not provided), as a first dose of measles, mumps, rubella, and varicella vaccination series (prophylaxis). On 31-JUL-2018, the patient received the second dose of their measles, mumps, rubella, and varicella vaccination series with PROQUAD, reconstituted with DILUENT MRK (inappropriate schedule of vaccine administered). No adverse effect were reported.
I experienced fatigue, stomach pain, diarrhea, weakness throughout my body, and shortness of breathe. I took off for 4-days to allow my body to recover from the vaccine for a month. I went into the doctor for my normal appointment on 04/07/2021 to have CBC panels drawn and informed him that I was having symptoms from the vaccine. He ordered a Thyroid test to find out why I was still having the symptoms. He decided to give me a B-12 shot and I was good for 5-days and all the symptoms came right back again. It's not an every day event now but I can tell that the symptoms are still there.
Swelling on hands, lower lip and jaw area. Weakness in left arm and very sensitive hands. Pain when there is pressure on hands or joints. Itchiness on the palm of hands. over 1 week since symptoms and still slight swelling.
Localized reaction following vaccine 12.5 mg BENADRYL given after discussion w/medical control. 11/30/09 - T.C. -> message/Dad called back and said child was fine. No follow up needed.
She woke up crying at 0330 and was burning up so I gave her TYLENOL and we went back to bed. Was ok most of the day and started getting fussy at bedtime. Gave her TYLENOL before bed. Began developing cough the next day. Cough continued the next day so I took her into her pediatrician and she tested positive. She continued to have a cough and low grade fever for the next 3 days.
After received the vaccine that evening i started getting nauseous. I took some Pepto and I went to bed. I walked upstairs I vomited in bathroom. 6 Hours straight I vomited and had dry heaves. The next day I did not eat much and I drank some. My stomach and digestive system was hurting bad. I thought it might be appendicitis and I called my Doctor. My doctor told me to go to the ER. I went to the ER and they ran tests. They stated they I was extremely constipated so they gave me medication. I went home and I was in so much pain I went back to the ER. They kept me over night for observation. I went home the next day and told me to take my meds a little at a time.
ELEVATED BP; "SPACEY"; MUSCLE CRAMPS; SORE ARM; EXTREME CHILLS; TIRED; This spontaneous report received from a patient concerned a 74-year-old white and not-Hispanic or Latino female. The patient's weight was 150 pounds, and height was 61 inches. The patient's concurrent conditions included high blood pressure, allergy to formaldehyde, paint, nail polish, raspberries and pepper. Patient was non-smoker, and non-alcohol user. Patient had breast cancer 15 years ago. Patient had allergy to new carpeting with fire protection coating. Patient did not have any drug abuse or illicit drug use. The patient experienced drug allergy when treated with Tylenol, sulfa drugs, ibuprofen, loratadine, and hydrochlorothiazide/losartan potassium for drug used for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 28-MAY-2021 to Right Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 28-MAY-2021, couple hours later vaccination, patient was tired and spacey. At around 10:30 pm, she noted extreme chills and muscle spasms. She could not warm herself up, and kept getting colder and colder. She went ER (emergency room) at 1:30 am because her BP (blood pressure) was high (176/110 mmHg). She left the ER at 5 am it was 150/80 mmHg. At the hospital, they gave her Tylenol, which helped her within an hour. They noted to add some Advil with the Tylenol for relief, and to continue for another 48 hours. Her arm was little a sore. It sometimes cramps in the area about every 8 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from spacey, and tired on 28-MAY-2021, was recovering from extreme chills, elevated blood pressure, and sore arm, and the outcome of muscle cramps was not reported. This report was serious (Other Medically Important Condition); Sender's Comments: V0: 20210557834-COVID-19 VACCINE AD26.COV2.S-Elevated BP. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: UNDERLYING DISEASE
10 days post immunization pt. began to have pain at injection site. She has been using ADVIL and heating pads with little to no relief. I referred her to her PCP for follow-up.
Product Storage Error; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a male patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2018-2019 season) (batch number 59TS2, expiry date 31st May 2019) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent 2018-2019 season. On an unknown date, unknown after receiving FluLaval Quadrivalent 2018-2019 season, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were reported as follows: The age at vaccination was not reported. The patient was inadvertently administered Flulaval QIV after the vaccine had been exposed to freezing temperatures, which led to incorrect storage of vaccine.   Follow up information was received from other health care professional on 11th January 2022: The patients demographics were updated. The patient received a dose of FluLaval Quadrivalent 2018-2019 season intramuscularly with dose of 0.5 ounce which was exposed to freezing temperature. The VAERs details were updated. Patient's age was provided as 5 Years however was not able capture due to Argus behavioral issue.
This spontaneous report was received from a registered nurse and refers to a 4 years old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 27-MAY-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # K021933, expiration date 10-NOV-2016, dose 0.5 ml, subcutaneously (anatomical location was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as all required information has been received.
3 days post vaccination I felt a tightness in my chest, that was only relieved with Albuterol asthma inhaler I use very infrequently, if I am hiking. It lasted for 4 days steady, then  disappeared.
I was working on my car in my garage. It was a nice fall day. We got our shots about 4:00 PM at the local stored. The pharmacist gave us the shots. I got a flu shot in one arm and a pneumococcal conjugate PCV13 shot in the other arm. About 7:00 PM, I started to get cold, achy and tired. By 8:00 PM, I went into the house. I have never been that cold before. I took a long hot shower and laid down on my couch and spent the night there. In the morning, I went to bed and spent the whole day there. I slept all night and woke up on Thursday 10-15-15 feeling normal. It is the first time I have ever got a bad reaction from a shot. I did not take my temperature. I was really sick! I've been normal since the 15th. I did not go to the doctor.
She got her vaccine, by that afternoon her arm started getting real hot.  The next day it swollen to almost double in size, and hurt bad.  She had fever of 101.5 for several days.  She went to the doctor and said that she had cellulitis and gave her an antibiotic which she was allergic to it and had diarrhea really bad.  She was then started on another antibiotic and got worse so she stopped taking that.  Her fever lasted for about 10 days and was not getting better and went to the ER and got a shot in her hip, and had to wait for 15 minutes, real thick.  She got better from that in about 4 days.    When she got her first booster on 12/8/21 she had a very similar reaction.  a nurse who felt that it was cellulitis and went to her PCP and that she had an infection that she had at the time of the vaccine.  It was a hard lump in her arm.  She went to the ER clinic and was given the shot in her hip.  He told her that he had seen arms that were that bad that had to be amputated.  The lump was not moving and did not move.   She recently went to an allergist and had testing done and was told that she was not allergic to anything.  She has been sick with a cold-like symptoms since January.   She did not get any reaction from the very first 2 boosters, and has never had a reaction and got the shingles vaccine 10 years ago, pneumonia vaccine about 5 years ago and gets the flu shot yearly with no reactions.    Her PCP does not believe in vaccines and told her not to get any of them.
Extreme headache Nausea Chills Muscle aches  All adverse symptoms lasted 4 days
cold sore-- as immune system was overwhelmed by the vaccine (herpes simplex 1)
Lymph Node swelling left armpit Fever  Chills Headache Body Aches Nausea
Onset hives 24 hours after HBV #3 and exacerbation of previously diagnosed Crohn's disease over following week. HBV #1 and #2 on 7/22/99 and 8/31/00 without problems.
Patient received the 1st Pfizer vaccine on Friday 4/9 at 3:15 pm; by 7:00 pm she started having symptoms. By 10 pm she was at the ER with trouble breathing, swelling in the hands, dizziness, fatigue/malaise, and headache. She left the ER before receiving treatment. The next day the patient went to an urgent care where she received a prednisone shot, prescriptions for 3 days of oral prednisone and an EpiPen, and was advised not to get the 2nd vaccine dose. On 4/19, the patient reported that she was still having breathing issues and headaches, and she was prescribed an albuterol inhaler. On 5/3, the patient reported improvement but that she was still experiencing shortness of breath with activity such as walking up stairs; Flovent HFA was prescribed. Heart failure, pulmonary embolism, and anemia were ruled out.
mom indicates that around 3:30 pt turned blue & started blanking out;all blood test that were done were nl results;ER felt pt may have had infect;no further vax containing pertussis;
had an erection since 2 weeks ago; 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) (Batch/Lot number: unknown) for 1 day as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ERECTION INCREASED (non-serious), outcome "unknown", described as "had an erection since 2 weeks ago".  Additional information: Consumer experienced a side effect following receiving a dose of the PFIZER-BIONTECH COVID-19 VACCINE. He mentioned that he had an erection since 2 weeks ago , that started after he got the vaccine. He would like to know if there are any ingredients of the vaccine that may have been the same ingredient that was in another Pfizer product (that causes erection) that may have caused that.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
About 15 minutes after my shot, I began to experience symptoms of an allergic reaction, similar to when I accidentally eat tree nuts. There was a tightness in my chest and a tingling of my lips. I brought this to the pharamacists' attention, and they gave me Benadryl and had me wait at the pharmacy, after making me promise to let them know if things got worse. In the next 15 minutes or so, I experienced additional allergic reaction symptoms, including swelling of the tongue and an itchy rash (although these were relatively minor). About an hour after I got the shot, I felt well enough to drive hom.
Erythema, edema, and warmth inferior to the injection site on the left deltoid
Patient was diagnosed with erythema multiforme seven days after receiving her first Hep B vaccine. She started showing signs of a  minor rash around her diaper area and her legs approximately four days after receiving the shot. The rash progressed over the next few days into lesions that resembled hives and spread all over her torso, back, neck, ears, face as well as both arms and legs and both hands and feet. The red lesions became more severe and she experienced swelling of her feet on day 8 after the vaccine to the point that it made her not want to walk. We had a visit with a nurse practitioner on day 7 and after conferring with Patient's doctor, she was diagnosed with erythema multiforme. No medications were given. The lesions finally cleared by day 13.
Subject developed uncomplicated varicella (primary) on 3-12-03 with crusting over on 3-18-03.  This event is consistent with vaccine failure from the administration on 3-26-01.
TINNITUS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced tinnitus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tinnitus. This report was non-serious.
Adolescent dose administered to adult; This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with hepatitis b vaccine (recombinant)(RECOMBIVAX HB) for prophylaxis.       On 2004 the patient experienced product use issue.    The outcome of product use issue is unknown.
Symptoms: Headache, Fever, Body Aches, Chills, Nausea, and Vomiting   12/30/2020: Headache started night of vaccination.  12/31/2020: Early next morning experienced chills and nausea. This was followed by vomiting, body aches, and fever.
Fever to 104.4 for 2 days seizure x 2 (day 1 & day 2)
Felt yucky; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 69-year-old male patient received BNT162b2 (COMIRNATY), on 28Feb2021 as dose 1, single (Lot number: EN6200) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history included: "Parkinson's" (unspecified if ongoing), notes: He has Parkinson's. The patient's concomitant medications were not reported.  The following information was reported: FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "Felt yucky".
I have been having intermittent paresthesias that began in my R thumb on 3/10 (day 4 s/p Pfizer #2)  around 4pm  and by 9 pm this had spread to my first 3 fingers on my R hand. My thumb was completely numb.  Woke up on 3/11 with no symptoms but by 11am my R thumb was numb again and this spread to my full hand/palm by 12pm, and then my L hand digits 1-3 and my L great toe and 2nd toe began tingling and felt numb. I started getting myalgias, L axillary pain but no palpable LAD, fatigue and a headache around 3pm and the paresthesias in my 3 extremities have recurred intermittently tonight. No pain or weakness in my extremities. Non-positional. No recent change in activities  (I workout daily for an hour but no new exercises). I?ve never had any neurological issues with my extremities in the past.  My only side effect after my Pfizer #1 on 2/14/2021 was just a few days of intermittent fatigue.
bad nightmares, yelling and screaming type of nightmares; bad nightmares, yelling and screaming type of nightmares; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 12Feb2021 (at the age of 61-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The caller stated she received the 1st dose on Friday 12Feb2021 and starting Saturday night she's been having "bad nightmares, yelling and screaming type of nightmares and it's every night" has this been reported with the vaccine. As per caller she saw the physician assistant today and mentioned this but was not aware of nightmares as being a side effect they also discussed other products she been taking for long time has not been taking anything new. Outcome of the events was unknown.   Information about lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
after vaccination patient start feeing dizziness and fainting. Pharmacist on duty helped the patient by checking blood pressure and pulse rate. Patient was give orange juice, after 10 minutes patient starts feeling better left pharmacy
This spontaneous report as received from a Medical Assistant refers to a multiple patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the patient was vaccinated with VAQTA lot # J0055713 expiration date 25-OCT-2015 and lot # K018182 expiration date 12-DEC-2016 (dose was not reported). The patient received a dose of VAQTA that was stored improperly. There was no adverse effects reported. Additional information has been requested.
Rash that started right upper arm and then went to left upper arm and down to bilateral LE. Rash gone one month later everywhere except right upper arm.
Patient received second dose of Moderna Covid-19 vaccine on Friday (4/9/21).  Patient reports she woke up on Sunday morning (4/11/21) and her left axilla was swollen.
Patient stated she noticed rash on wrist on 10/28/2020 (the day after receiving shot). On 10/29/2020 patient noticed rash also on ankle and forehead. She states the rash is itchy. Patient was going to call her doctor, to discuss adverse event.
Per patient's sister, starting 10/1, confused, disoriented, and not communicating. He was then transported to Medical Center via EMS where he is still hospitalized.
p/vax episodic irritability crying & vomiting; few hours later large bloody stool; seen in ER & adm with R/O intussusception