chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from healthcare professional on 30 July 2014. Additional information received for this unsolicited case on 21 November 2014 resulted in the case being upgraded to serious. A 32-month-old male patient, whose medical history and concomitant medications were not reported, had received intramuscular dose of DT Pediatric, batch number: C4161AA (dose number was not reported) in left deltoid on 24 July 2014. It was reported that on 25 July 2014, one day after receiving DT Pediatric vaccine, the patient experienced redness, swelling and puffiness of his left arm from shoulder to the wrist with limited range of motion over the course of 4 days post vaccination. The physician prescribed amoxicillin and MOTRIN as a corrective treatment with no laboratory investigations. It was reported that, the symptoms were resolving with improvement of symptoms with only slight swelling. As per reporter, no further physician evaluation required. At the time of this report, the outcome was recovering. Documents held by sender: none. Follow up information received from healthcare professional on 06 Oct 2014. It was reported that patient had amoxicillin 200 for 5 days (handwritten). The outcome of all events was reported as recovered. Additional information was received from the patient's parent on 21 November 2014. The patient had received the vaccine on 24 July 2014 at 7:00pm, and symptoms started on 24 July 2014 at 9:00pm. Ten days after vaccination, the patient experienced an asthma attack and was subsequently diagnosed with reactive airway disease. He was currently on multiple medications per the parent. These events had not recovered. Additionally, the parent provided more information regarding the state where the vaccine had been administered.
Numb tongue, flushed cheeks, vitals assessed. 50mg Benadryl administered at 1036, patient evaluated at 1100. Patient discharged home at 1105 and advised to call 911 if feeling worse and to follow up with HCP.
Cellulitis at injection site with radial inflammation 6 inches in circumference. Requiring ABX.
That evening- horrible convulsions for over 8 hours.  Thankfully it passed.   But 2 days later,  my right eye became bloodshot & blurry.  Swollen lid. Soon both eyes were red,  dry gritty, red with blurry vision.  THESE SYMPTOMS STILL PERSIST! I NEED HELP!
Patient felt like a lump in his throat.  No difficulty breathing or swallowing.  VS 110/70 P. 56 Patient drank water and felt a little better.  He went outside and felt better after removing mask.  He felt it was starting to go away but was still there on one side.  Both parents were with him and he went to the ER with them in their vehicle.  This was dose 2 of Pfizer and he had no difficulty with the first dose.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Apr2021 16:00 (Lot number: EW0170) at the age of 33 years as dose 2, single and administered in arm left, administration date 02Apr2021 08:30 (Lot number: ER8734) as dose 1, single for Covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "tiredness". Therapeutic measures were not taken as a result of pain in extremity, fatigue. Additional information: The patient would like to mention after my 1st and 2nd dose I had almost no side effects. Just a sore arm and tiredness. The patient did not take any other vaccine in four weeks prior COVID -19 vaccine. She was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. The patient had no known allergies. The patient received iron supplements 25 mg within two weeks of vaccination. No follow-up attempts are possible. No further information is expected.
I was given the Covid19, Moderna, Vaccine on 10MAR2021.  On 17MAR2021 (0700 hrs), I woke up and my arm, at the injection site, was itchy.  By 1100hrs, the injection site was swollen and warm to the touch.  It was similar to a mosquito bite with swelling around it.
pt brought to ED with SOB and AMS x 2 days; 5 days earlier, pt saw PCP and was given ABX; dx in hospital with acute on chronic respiratory failure; on BiPAP; tested positive for COVID; steroids; DNR/DNI; once stable, pt dc'd to home with hospice; pt passed away in the home
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient had a mild fainting episode and was conscious within minutes, I had the patient wait for 30 min prior to the event to ensure there were no residual issues and patient was fine. (Gave patient zyrtec)
hair loss; she's suicidal; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 31-year-old female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in Apr2021 as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ALOPECIA (non-serious) with onset Jun2021, outcome "unknown", described as "hair loss"; SUICIDAL IDEATION (medically significant) with onset 2021, outcome "unknown", described as "she's suicidal". The events "she's suicidal" and "hair loss" required physician office visit. Therapeutic measures were taken as a result of suicidal ideation, alopecia.  Clinical Course: AE: hair loss: Caller said her daughter started to notice the hair loss approximately two months after her second vaccine, and noticed it increased about two months after the third vaccination. She said it got worse after the third vaccination, and did not seem to have slowed much, between that it had waxed and waned. AE Treatment: Caller said her daughter has been to an endocrinologist, a dermatologist who specializes in hair loss with a hair and scalp fellowship, and an immunological dermatologist, for the purpose of finding out what is going on with the hair loss. She says her daughter tried quite a few things but nothing seems be working. She said her daughter tried vitamins and nutritional supplements mainly, and she took some iron supplements and B12 supplements. NDC/LOT/EXP: Unknown for the B12 and iron supplements that the patient took. She said she took those only after the hair loss for the purpose of trying to help the hair loss. She says she lives in a different state, so she doesn't know the dosage her daughter took, only that it was within recommended dosing.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
COVID-19 symptoms started 07/19/22; tested positive 07/19/22. I woke up not feeling right and took the test and yesterday I went to the health clinic and they did another test and it was positive. Symptoms were slight headache, body aches, stuffy nose, and slight cough. It's been changing and Tuesday night I had a little fever of 99.6 and yesterday there was no fever and never came back. Today 07/21/22 I am stuffed up with a little cough and sneezing. I talked to someone yesterday about getting the antiviral and they're in short supply here and they're trying to keep it reserved so I am holding off and if I get sicker I can go get it.
Administration Error: ?         Pfizer Covid-19 Orange Top vials (Pediatric age 5-11) were diluted and administered following the Pfizer COVID-19 Purple Top vial (Adolescent age 12 and older) preparation and administration instructions. ?         1.8 ml was used to dilute the 1.3 ML vial instead of 1.3 ml. ?         This would change the concentration to 130 mcg/3.1 ml = 41.9 mcg/ml. ?         The dose given out of this vial was 0.3 ml. ?         The children (age 5-11) received 0.3ml x 41.9 mcg/ml = 12.6 mcg.  Pfizer Case #: int00506363
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Oct2022 as dose 5 (booster), single (Lot number: GJ6665) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, treatment included Paxlovid from 23Mar2023 to 27Mar2023.
1/24/08 onset right flank rash-itchy vesicular anterior and posterior.
Local allergic reaction - swelling, urticarial rash, surrounding vaccination. 7cm diameter within 30 minutes of vaccination.
fever at 101 f; Body aches; chills; sleeplessness; head ache; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 at 07:30 as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included hydrochlorothiazide (MANUFACTURER UNKNOWN) from an unknown start date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took codeine and experienced allergy.  The patient also previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Mar2021 at 07:15 as a single dose for COVID-19 immunisation. On 10Apr2021 at 00:00, one day after vaccination, the patient experienced fever at 101 Fahrenheit, body aches, chills, sleeplessness and headache. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events fever at 101 Fahrenheit, body aches, chills, sleeplessness and headache was resolving at the time of this report.    No follow-up attempts are needed. No further information is expected.
Fever of 102.7 ran for 2 days followed by a mild flat rash from the area behind the ears extending down torso to knees.  The fever responded to Tylenol.  The rash is still present.
A lot of blood clots in his left leg; This is a spontaneous report from a Pfizer Sponsored Program via Regulatory Authority Support from a contactable consumer (patient).  A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and the patient's concomitant medications were not reported. on unknown date the patient had blood clots, a lot of blood clots in his left leg. He had surgery before second dose was scheduled. The outcome of the evens was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Tired, chills, nausea, sore at inj site H/A, achy feeling.
Had severe pain that first started in elbows, then wrists, then knee, then all knuckles left and right hand.  Never had ANYTHING like this before. Also swelling in arms, hands and knee
vaccine was given on 01-Jul-2020 which was expired on 31 may 2020/no AE; Initial information was received on 07-Jul-2020 regarding an unsolicited valid non-serious case received from a non health care professional (office staff).  This case involves an 11 years old female patient who was vaccinated with once 0.5 ml first dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] on 01-Jul-2020 which was already expired on 31-May-2020 (batch number U6220AA) via intramuscular route in the left arm for prophylactic vaccination (expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX).  It was an actual medication error case due to expired vaccine used.  At the time of report no adverse event was 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.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 at 11:45 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 09Apr2021 at 13:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 30Apr2021 at 13:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 04Dec2021 at 18:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies" (unspecified if ongoing); "Seasonal allergies: dust" (unspecified if ongoing); "Seasonal allergies: mold" (unspecified if ongoing); "Seasonal allergies: ragweed" (unspecified if ongoing); "Seasonal allergies: grass" (unspecified if ongoing); "Seasonal allergies: cat" (unspecified if ongoing); "Seasonal allergies: allery to rabbits, guinea pigs" (unspecified if ongoing); "Seasonal allergies: some dogs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Oct2022) Negative; (10Oct2022) Negative; (12Oct2022) Negative; (16Oct2022) Positive, notes: two rapid tests confirmed that I was positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
After the second shot the area around the shot hurt and had a lump. After about 4 days it went away. No other reactions. About a week later it flared up again and was very painful. It lasted about 3 days. I called my family doctor in April because this still continued. Dr. said to take Advil and use an ice pack on it when it flares up. I have been using the ice packs and Tylenol. Advil upsets my stomach to much. To this date, May 10,2021 these flare ups still continue. The pain is at the injection site, in the muscle and is very painful. The pain will last anywhere from five minutes to 15 minutes. Dr. said there is no way to tell how long this will go on. The flare up will last around three or four days, go away for two or three days and then start up again.
Child received vaccines for his sibling. Provider input vaccines to wrong patient chart and gave verbal order to give vaccines to wrong patient.
Pain, redness, and warmth at injection site, dizziness/unbalanced, and fever which occurred within one day of injection
This spontaneous report as received from a health professional refers to a 13 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 30-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Within 10 days I had symptoms of headache, sinus congestion, body aches, chest pain and mild dry cough. It turned into a bad ?cold or flu-like? feeling. I did an E- visit thru my insurance company because I thought I had a secondary infection starting. They prescribed Augmentin for 10 days. I took and it didn?t help. I then went to medical facility and they did Rx for Z Pack. It didn?t help and my chest was hurting so bad I thought my ribs were broken. Went back to them and they called in an inhaler for acute bronchitis. XRay showed no pneumonia. Diagnosed me finally with costochondritis. Gave Keterolac shot that did not help. Now I am just fighting it at home and the pain has intensified all around my rib cage. I have been putting off my 2nd vaccine dose because of illness and PA?s recommendation.
pt recv vax 16JUN97 & devel a sterile abscess @ the inj site;
Baby had fever of 103 rectally, diaper rash, heavy breathing. decreased po intake both fluids and solids. Received Tylenol on 6/25/2019 and 6/26/2019. Temp. down yesterday but back up today and still not feeling well. Baby is just lying around and crying.
I was 8 weeks pregnant at a time, baby was diagnosed later with kidney issues and heart defect, had to terminate pregnancy. Vaccine was H1N1.
Swelling, painful, vomited last night, chills, fever and pain under left armpit. Saw MD (states increased stress lately).
Patient was fully vaccinated for COVID but was hospitalized for COVID symptoms on 9/7/2021 at Hospital
near syncope w/in 30 min. of vaccine- taken to ER immediately monitored, EKG,  and kept for observation increased heart rate, light headed, orthostatic after vaccine continued w/ rapid heart rate, light headed and orthostatic for 3 days day 2 severe body aches, chills, fatigue and headache,, arm pain only at injection site, swollen lymph nodes- Tylenol taken but barely touched pain day 3 still joint aches and headache, fatigue and chills, slight arm pain only at injection site, swollen lymph nodes- Tylenol and rest day 4 felt better, rash began on torso and spread to arms, groin , neck,  swollen lymph nodes day 4 rash which began to itch lasting day 4,5,6,7,8- took Benadryl so I could sleep, swollen lymph nodes Continue w/ intermittent chills, body aches, headache  and light headed for day s 4,5,6,7,8 Continue w/ swollen lymph nodes under left and right arm and today is day 14
Bad headache; Hot flashes; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot flashes), HEADACHE (Bad headache) and CHILLS (Chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.  On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2012, the patient experienced CHILLS (Chills). On 13-Mar-2021, the patient experienced HOT FLUSH (Hot flashes). On 15-Mar-2021, the patient experienced HEADACHE (Bad headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, HOT FLUSH (Hot flashes) and CHILLS (Chills) had not resolved and HEADACHE (Bad headache) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Treatment medication include paracetamol and patient took Tylenol for bad headache. Concomitant product use was unknown by the reporter. There was no blood in the urine it was a large amount of beet consumption was updated in follow up. It was also reported that 2nd shot went well no side effects.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-up information received on 10-May 2021 through email. Patient updated about the events, action taken updated and states that patient has been administered with second shot with no side effects.
Patient felt palpitation evening after shot. Presented to ER for tachycardia - EKG revealed no arrhythmia. HR was 131 on presentation to the ER.
She got her vaccine, after the 45 minutes her hands started swelling up, and her throat started tightening, about to close kind of feeling.   She took some Benadryl and passed out for the rest of the day.  Then about a week later the injection site started getting puffier and the whelp is now the size of her fist and is red and purple.   She saw her PCP who is calling her in something stronger than Benadryl.
Patient stated he "could not breath" so had to call paramedics for assistance. Also has no feeling in his left arm all the way down to his hand.
- Very severe migraine for five days.  Vomitting for multiple days with migraine. - Very lethargic. - Blood pressure was extremely high / very abnormal.  Had to go to ER due to BP being so high/dangerous levels.  No high blood pressure history.  Was put on blood pressure medication and still taking it.  Blood pressure is getting closer to normal, several weeks later.
Expired Moderna vaccine administered to patient. Vaccine expiration date was 9/28/21 per manufacturer.
Post vax, on approximately 12/04/2000, the patient experienced a "full blown pox" - chicken pox. Additional information has been requested.
Patient had shortness of breath/wheezing about 3.5 hours after administration of vaccine that lasted 3 hours.