chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Local swelling and moderate pain without redness, bruising, fever, airway involvement, or mental status changes.  Treated with Ice, Tylenol, rest.
Had a seizure about 02:00 while sleeping.  Whole body shakes, bit inside of mouth very severely, lost control of bowels... and I don't remember one bit of the entire event.  Husband called 911, EMTs transported to hospital ER.
mom reports that pt awoke 8OCT97 w/ sore throat, cough, hoarseness & blisters in mouth, swelling of face, arms, & hands, tiny red spots over entire boy;took to MD & was put on ampicillin;mom states that sx began to recede by 10OCT97;
pain/swelling at the injection site.  Fever and body aches for two days after the injection.  Max temperature was 100.2 F.  No treatment, just bed rest until the symptoms went away.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 25Oct2021 as dose 1, single (Lot number: FH8020) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Sarcoidosis" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE, start date: 07Aug2022, stop date: 11Aug2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Aug2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Aug2022) Positive; (29Aug2022) Positive; (29Aug2022) Positive; (26Aug2022) Negative; (26Aug2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 22Aug2022 to 26Aug2022 .
Patient presented to Emergency Department on 4/17/21 with a severe headache that started 5-7 days prior. CBC and Chem-8 were normal with platelets of 314.  Findings from CT head venogram showed irregularities of the left transverse sinus with possible sinus thrombosis. Patient was admitted for further work-up and treatment. Patient was followed by Neurology. On 4/18 MRI revealed no cavernoma seen and no stroke or hemorrhage. Per Neurology, the areas of filling defects seen on CTV are still present which could be nonocclusive thrombus vs stenosis with prominent arachnoid granulations, but given history and risk factors, would treat as cerebral sinus venous thrombosis. Patient was treated with heparin then transitioned to apixaban, which she was discharged on. Patient was instructed to follow up with neurology in 3 months for a repeat CTV. Patient was discharged 4/19/21.
Headache,  extreme fatigue, nausea, loss of appetite, fever, body aches, chills, sweating, loose stools
During administration of the vaccine in my left arm, the needle came off ("popped off") of the syringe. Doctor and tech said they were using a new shipment of syringes that were bad quality. Because of this, I had another dose of the vaccine in my right arm. It was an honest mistake and was handled appropriately. I am reporting as a means for documentation and scientific study of potential extra-dose effects of the Pfizer-BioNTech COVID19 vaccine.
On day 8, March 12, lymph nodes under right arm became swollen and slightly tender and on day 9, March 13, I woke up to a round hard knot at injection site, the size of a half dollar coin. It?s hot to touch, a little itchy and painful.
Vaccination on Friday. Aches and stiff joints started early on  Sunday. I hardly slept that night alternating from being too hot to too cold. Monday evening around 6pm: Chills started, sinus congestion, runny nose, general weakness,  shortness of breath. I took a hot shower and later used a rescue inhaler and was able to get my breathing back to normal. I  dressed in warm clothes and went to bed fully dressed around 10pm. 8am Tuesday I got up after a sound sleep and the symptoms were mostly gone except for a little sinus pressure and some joint soreness.
Chest pain started the night after taking the vaccine.I have had from 5-25 episodes a day lasting anywhere from 5-45 seconds and ranging in pain severity. Starts as burning sensation and then becomes sharp. Started to have high blood pressure as well. Started having dizziness and headaches. Have had the chest pains every day since the vaccine. Was put on anti inflammatory medication and blood pressure medication.  Pain got better with medication and blood pressure medication was increased do to continuing to have high blood pressure.  In May of 2022 I felt much better, then  early June got Covid and inflammation went back high again and my pain increased significantly.  I?m back on anti inflammatory medication and continuing to limit my physical activity per my doctor. My treatment physically initially was to take it easy and let the inflammation come down. After that was not helping, was put on the anti inflammatoeynmedication.  Am currently on anti inflammatory medication with limited physical activity.
37 days now/ can't get in until 11Jun2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION ( 37 days now/ can't get in until 11Jun2021) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 04-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION ( 37 days now/ can't get in until 11Jun2021).   On 04-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION ( 37 days now/ can't get in until 11Jun2021) had resolved.      Concomitant product use was not provided by the reporter. No treatment information was provided.
TACHYCARDIA; TINNITUS; CHEST TIGHTNESS; LEG PAIN; LOW GRADE FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 tachycardia, tinnitus, chest tightness, leg pain, low grade fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tachycardia, tinnitus, low grade fever, headache, chest tightness, and leg pain. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
Patient received Zostavax 2 1/2 weeks ago. She developed right sided head pain 2 weeks ago, right facial pain and sensitivity 1 week ago and rash on face 3 days ago consistent with a clinical case of Zoster -shingles- involving the trigeminal nerve 1st and second branch. No eye involvement thus far.  7/15/08 Reviewed PCP medical records of 5/12-6/9/08. FINAL DX:  Facial shingles w/trigeminal nerve involvement Records reveal patient w/left ear drainage & pain on 5/12 & tx w/topical & oral antibiotics.  RTC 6/9 with shooting pain right scalp x 2 wks which had progressively gotten worse.  Facial rash x 2-3 days w/burning sensation.  Exam revealed erythematous papules & vesicles on right face w/ulcerations, hemorrhagic crusts, increased touch sensitivity over face & right scalp.  Tx w/antibiotics & pain meds. Follow-up: The patient developed clinical zoster a few days after receiving the vaccine. The rash cleared after 3 weeks, but pain persisted despite Acyclovir and gabapentin initially. Gabapentin ongoing for about 6 more weeks. She had recurrence of similar pain mildly 6 months later which resolved after about 1 week without Rx. Today feels well.
most recent period "seems different" and is "redder, heavier, and more clotting" than normal; most recent period "seems different" and is "redder, heavier, and more clotting" than normal; This is a spontaneous report from a contactable 50-year-old female consumer reported for herself via medical information team. A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 23Aug2021 as single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. She reported that her most recent period "seems different" and was "redder, heavier, and more clotting" than normal, her period started on 12Sep2021. She's also seen social media reports of changes in menstruation. She's decided not to take the second dose. She did indicate she was approaching menopause, and that she has an appointment scheduled with her doctor. She experienced changes in her menstrual cycle after receiving the first dose of the Pfizer-Biontech Covid19 vaccine. She asked, the vaccine does require an immune response, right? Could that cause changes in her menstrual cycle? She was asking have other people reported similar changes to menses after vaccination? Will there be additional studies looking into menstrual changes? No studies for changes in menstruation. Provided that there was an arm of the study that focuses on pregnant women. The Comirnaty Prescribing Information and the authorized Prescribing Information for the Pfizer-BioNTech COVID-19 Vaccine do not list menstrual changes as adverse reaction from clinical studies and post authorization experience. The organization that provides leadership in education, research and gynecologic care to improve the reproductive health of young people states that: There have been anecdotal and media reports of irregular menstrual cycles, including skipped periods, prolonged periods, spotting after COVID-19 vaccines in adults and similar changes in menstrual cycles have been reported after COVID-19 infection. This was not surprising because infections, immune reactions, and fevers can cause short-term, self-limited changes in cycles. However, further studies are needed to verify these changes in people who have received COVID-19 vaccines. Reporter considered events as non-serious. The outcome of events was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Patient had a slight sore arm the next day, no other event, patient was fine two days after.
Every time I begin to walk I became out of breathe. I would need to sit for moments at time to regain my strength. I'm currently still having issue with breathing.
Dizziness, increase heart rate, headache, leading to muscle weakness, fever of 100.5F, nausea, chills, sweating, and was sick for 72 hours.
Initial misuse report received from a nurse on 08 November 2013. The pregnant patient had received two doses of FLUZONE QIV. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Patient called 9/27 to report she started experiencing redness of injection site which then radiated down her arm and into her chest area. She reported feeling a numbness and heaviness of her arm.
transient large macular rash scattered throughout a field of fine macular rash w/extreme itching-lasted about 2 hrs then disappeared to appear somewhere else; lasted approx 2 wks; 1st appeared on face about 2 hrs p/inject;
Extreme "brain fog"; Feels kind of dizzy but not really dizzy; Feels like my head has so much pressure like it is going to explode/ Feels like head is in a glass jar; Symptoms are getting weirder and weirder/ Getting intermittently worse; A spontaneous report was received from a healthcare professional concerning a 60-years-old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced foggy feeling in head/feeling abnormal, dizzy/dizziness, head pressure/head discomfort and  condition aggravated  The patient's medical history was reported as Crohn's disease, left ventricular non-compaction, and had COVID-19. The Concomitant medications reported were metoprolol succinate, furosemide, potassium, acetyl salicylic acid, sertraline hydrochloride .  On 20 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012L20A) Intramuscularly for prophylaxis of COVID-19 infection.  On 2 Feb 2021, the patient experienced  extreme brain fog, feels like head is in a glass jar, kind of feel dizzy but not dizzy, head pressure like it is going to explode, symptoms got weirder and weirder, feeling very unusual. The patient reported that the brain fog initially started with covid-19 infection which she had in the past and she noticed it around 02 Feb 2021.The event got worse since 06 Feb 2021.The patient also enquired if this is an expected event after the vaccination.  The treatment information was not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, extreme brain fog, feels like head is in a glass jar, kind of feel dizzy but not dizzy, feels like my head has so much pressure like it is going to explode, symptoms are getting weirder and weirder, feeling very unusual, getting intermittently worse were considered unknown.
Body temperature 100.2, vomiting, headache, body ache, shortness of breath.
I get the vaccinations. Last one was less than a year ago. I have shingles now /suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for an unknown indication.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine and unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received last dose of shingles less than a year ago and had shingles now for 3rd time in adult life. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation for shingles were not provided.
This spontaneous report as received from a pharmacy technician refers to a 4-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 22-JAN-2018, the patient was vaccinated with improperly stored dose of Oka/Merck VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The Oka/Merck VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
Developed shingles in a very healthy and active young male  about 4 days following first dose.
Fever around 101, ache all over, cough and sore left arm.  All symptoms were gone in 24 hours except a cough which lingered until Monday 1/11/2021.  Vaccine was given on 1/7/2021.
Arm swelling; pain (arm pain); The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 08Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable nurse (patient) received via a Pfizer-sponsored program. A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose as COVID vaccine. Medical history and concomitant medications were not reported. He's an RN and thinking about taking the COVID vaccine. He's concerned, he's reading the paperwork on it. Was it the insurance company that would pay- would his supplement pay for this or what. He would probably have another question- how would he know if he has had an allergic reaction to the ingredients. The ingredients were listed he believed that Pfizer would have to know because he did not know what the listing ingredients were, he didn't know if he has ever had an MRNA lipid vaccine or anything like that. He would start with whether or not he's going to have to pay for the vaccine. Then on 08Jan2021, it was reported that after the 1st one, the patient had swelling of arm and pain (arm pain) after the first COVID vaccine dose, both on unspecified dates. The outcome of the events was unknown.  Information about batch/lot number has been requested.
Itchy throat/tongue, skin 11AM- Treated with oral antihistamine and nasal spray Headache, Nausea, Fatigue 2PM Muscle aches. low grade fever, chills- 5PM Treated with Tylenol All symptoms above continued for 24-36 hours.
fever 105 w/in 22hr of vax associated w/a febrile sz x 1-lasted 5min;LP done;inc WBC, aseptic meningitis;? coincidental viral meningitis vs vaccine associated;
Had  COVID -19 two weeks after the vaccine. Tired and really bad chills prior to testing positive to COVID 19 after vaccination.
Heavy nausea, cold/clammy hands (all day), headache, body chills, fatigue, body pain, back pain, discomfort
her hands are very dry and peeling / Her elbow is peeling. feels dry and rough; arm was sore; Peeling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Mar2021 17:56 (Lot number: ER8733) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergies" (unspecified if ongoing); "Foot injury" (unspecified if ongoing); "kidney damage" (unspecified if ongoing); "Foot surgery" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRY SKIN (non-serious) with onset 27Mar2021, outcome "not recovered", described as "her hands are very dry and peeling / Her elbow is peeling. feels dry and rough"; PAIN IN EXTREMITY (non-serious) with onset 27Mar2021, outcome "recovering", described as "arm was sore"; SKIN EXFOLIATION (non-serious) with onset 27Mar2021, outcome "not recovered", described as "Peeling".  Additional information: The patient stated she took the shot last Saturday and she experienced skin peeling. Patient talked to her friend who got the vaccine on the same date and her friend said she had itching. A clone report was created to document the friends experience. Reporter clarified she received the first dose of the Pfizer COVID 19 vaccine 27Mar2021 on 1756PM in the left arm. Her arm was sore for two days, she could not lay on it and it hurt until Monday; it still hurts if she pushes on it. The day of the vaccination, she noticed peeling on her thumb; then on her fingers and elbow; and her hands are very rough and dry, like someone put some glue on her. She did some cleaning the other day but it usually does not do that. Add the peeling was on both of her whole hands, back of her hands, knuckles, the palm on both hands, and the middle finger on the right at the tip has peeled a lot. The other peeling places are just patches, and on her left elbow. She was scheduled to get the second dose on 17Apr2021. Mentions she called Pfizer first but she is going to call her HCP next.  No follow-up attempts are possible. No further information is expected.
Breakthrough case admission after 2 vaccines  Pfizer 5/24/21 Lot# Ew0172;  Pfizer 7/7/21 Lot# Ew0173
This case was reported by a healthcare professional and described the occurrence of inadvertent overdose in a 17-year-old male subject who was vaccinated with Boostrix, GlaxoSmithKline for prophylaxis. The subject had no known relevant medical history. The subject had no known concurrent medications, but the reporter was uncertain. Previous and/or concurrent vaccination included Vaqta given on 29 March 2007; Menactra; Sanofi Pasteur MSD given  29 March 2007; Boostrix, adsorbed given on 29 March 2007. On 29 March 2007 at 10:30 the subject experienced mild discomfort at the injection site of both Boostrix injections. The event resolved in three days on 01 April 2007. She considered that the events were related to the use Boostrix.
Patient complained of severe arm pain, could not remove her work smock, high tolerance to pain (stated by patient), "but this really hurts", left arm.
the vaccine had excursion earlier today and was opened, vial was not stable. a child was given a dose from this; Initial information received on 14-Aug-2019 regarding an unsolicited valid non-serious case received from a health care professional.   This case involves a 4 years old male patient who received 0.5 ml dose of IPV (VERO) lot P1E701M (Expiry date 09-Nov-2020) via intramuscular route in the right thigh on an unknown date.   The patient's medical history, past vaccinations and family history was not provided.  concomitant vaccinations included 5th dose of DTap, 2nd dose of Varivax and 2nd dose of MMR.  It was a actual medication error case due to incorrect product storage.  It was reported that excursion earlier today and was told Ipol open vial was not stable. She said she found out that a child was given a dose from this vial today.  At a time of reporting no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
In my right eye everything is wavy. The pigment in my eye is starting to deteriorate. They said my retina and optic nerve are fine right now. They have not prescribed medication.