chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient tested positive for COVID despite being fully vaccinated with BNT162b2.(Blood test); Patient tested positive for COVID despite being fully vaccinated with BNT162b2.(Blood test); This is a spontaneous report from a contactable consumer.  A 21-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE and dose 2 intramuscular, administered in Arm Left on 31Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation at School or Student Health Clinic. The age at vaccination was reported as 21 years. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 20Jul2021, the patient tested positive for COVID despite being fully vaccinated with BNT162b2. The lab test included patient had blood test (SARS-CoV-2 test), result: positive for COVID despite being fully vaccinated on 20Jul2021. The adverse event required doctor or other healthcare professional office/clinic visit. The patient not received treatment for the events. The outcome of the events was recovered on an unspecified date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
had both of the injections and still get shingles; still get shingles; Spots aren't as large but still here; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and spot-like rash. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the spot-like rash was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and spot-like rash to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient reported that the patient received both of the shingles injections and still get shingles. Spots were not as large but still here. The case was considered as suspected vaccination failure since the details regarding, time to onset and laboratory confirmation of shingles was not reported.
PT reported had a day of weakness and somnolence with 1st Hep B injection on the day she came to receive dose #2 (employer wanted her to have series because of some janitorial duties). After 2nd dose, in approx 1 hr, began w/some SXs of weakness and somnolence.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 16-SEP-2104 the patient was vaccinated with (Merck) VARIVAX (dose, units, route of administration, anatomical location, lot# and expiry date were not reported) which was exposed to a supported temperature excursion on 15-AUG-2014. No adverse events had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Within 24 hours of HPV dose given on 08/27/2008 - Had rash over trunk of body, Lasting 3 days did not seek medical attention. Within 24 hrs after 6/25/2008 vaccinations- had high fever, muscle aches 3-5 days, did not seek medical attention.
Fever. 102.9. Chills. Nauseous. Vomited.
Wheezing for air, heart palpitations, red rash on face, neck, and arms, hot feeling on the skin, weak and dizziness.
Approx 2 minutes after injection I felt warm, flush, tachycardic, dizzy, my hands were shaking and my throat felt numb and a little swollen. I was still able to swallow and symptoms did improve after 15 minutes.
PEDIATRIC PFIZER WAS ADMINISTERED UNDILUTED TO CHILD. BOTH PARENTS REPORTED NO ADVERSE EVENTS.
Redness at site of DTAP the size of a golfball and hard X 48 hours, then broke out with 4 hives on lip, neck and on arm. It is itching at injection site. Treated with Benadryl and went to ER. Instructed by ER to continue Benadryl. Redness increased  in size, was warm and itchy.
Within a few minutes of receiving the shot I passed out and possibly had a seizure and threw up.
No adverse event; 35 patients received a 0.25 ml dose as booster from booster dose only presentation vial; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In July 2022, the patient experienced ACCIDENTAL UNDERDOSE (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial).    No concomitant product use was reported.   Vaccination dates reported as between 22-Jul-2022 and 28-Jul-2022.  The information was unknown if patient experienced any symptoms after administration of the vaccine.  Treatment information was unknown.
Pt recv vax on 11/30/98; on 12/8/98 pt exp ill feeling & stiff neck
Lethargy after immunization. Started aprox evening through night until early afternoon, aprox 18 hrs and low grade fever.
Administered vaccine and had patient sit and wait.  After a few minutes, the patient felt dizzy, rapid heart rate and was sweating.  I went out to check on him and gave him an ice pack and had him put it on the back of his neck.   After no improvement, the pharmacy manager went out and took his blood pressure, which seemed low.  She had him lay on the ground with his feet elevated on a chair for 10minutes.  He then felt better and sat back up.  He sat for another 15 minutes, until he felt comfortable enough to walk around.  After a little while longer, he felt comfortable enough to leave.
Day 1 - bad taste in mouth,  fuzzy vision, bad headache, tiredness, equilibrium off, nausea, soreness & pain down entire left arm  Day 2 - left arm very sore, nausea, bad headache, fuzzy vision, feeling very sick Day 3 - very tired and body aching all over, dull headache Day 4 - extreme pressure in head, difficulty concentrating, pain in ears, loss of hearing in right ear until aprx 8:00 PM, overall feeling sick Day 5 - Hearing ok, tiredness and body aching with leg pain Days 6 thru 10 - body breaking out in sweats Treatment:  Tylenol, Advil, rest Outcome:  Felt better after Day 10
Persistent significant, overwhelming  fatigue.  This occurs usually after moderate to light physical activity.  Occasional brain fog  also occurs.        This condition also occurred after a Pfizer booster given on 4/19/22 but that time instance went away after 3 months.
1015: Pt in 15-waiting lot after 1st dose of Pfizer vaccine. C/O lightheadedness. RN and NG medic responded to vehicle. Vital signs WNL.  Had not eaten  breakfast but does not typically eat in a.m. RN provided snack and water. Advised MD by phone. 1030: Pt reports chest discomfort to L chest area. Denies tightening or sharpness-- just discomfort. No other symptoms reported. Lightheaded feeling improving. VS remain stable. MD  again contacted. Advised family member to come and transport to ED if chest discomfort persists but is not urgent.  1107:Pt reports sensation improving and feels ok to drive home (10-15 minute drive.) RN instructed to pull over and call 911 if symptoms worsen. MD advised pt leaving.
stroke; This case was reported by a consumer via interactive digital media and described the occurrence of stroke in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In August 2020, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced stroke (serious criteria GSK medically significant). On an unknown date, the outcome of the stroke was unknown.   It was unknown if the reporter considered the stroke to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient got a stroke by taking vaccine shingles. The follow-up could not be possible as no contact details were available.
shortly after receive shot patient began to feel light headed. she stated her tongue started to tingle. Symptoms progressed to chest pain and throat itching.  Pt was given 25mg of diphenhydramine at vaccination site. Pt started to improve.  Pt declined emergency care. Followed up with pt next day and pt stated taking diphenhydramine every 6 hours but was feeling much better.
Information has been received from a 24 year old female with papilloma viral infection who on 23-FEB-2007 was vaccinated with Gardasil (lot #654702/0011U). Concomitant therapy Nuvaring. Subsequently the patient experienced arm pain, swelling, itchiness, redness, and lump at injection site on left deltoid. Unspecified medical attention was sought. The patient status was reported as recovering. No product quality complaint was involved. Additional information has been requested.
Broke out what appears to be shingles; This case was reported by a consumer and described the occurrence of shingles in a 57-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In November 2019, less than 6 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received first shot and due for the second. According to day of reporting this weekend patient broke out what appears to be shingles and enquired should patient still get the vaccine shot. The reporter consent to follow up.
The pt received the Pfizer vaccine and after 1-2 minutes of sitting the pt fainted and bumped his head on the concrete floor.  The pt was sweating and not responding for about 5 minutes, after the pt was awake and the EMS saw him the pt started feeling much better and did not wan t to go to the  hospital.  The pt only had juice and it was after 1:00pm so this could have been a contributing factor.  The pt stayed 30 more minutes with me after the EMS left and he was completely fine.  I also think the pt since he was a minor was really nervous.
Hives on face and buttocks started 2 jours after vaccination.  Benadryl 50mg po. HIVES RESOLVED
After receiving vaccine patient started to complain of shortness of breath. Patient appeared to be short of breath, but no apparent distress noted. Called EMS immediately after patient reported symptoms. Patient transported to the hospital. Called patient the next day after vaccine was given. Patient states she was not given any medication at the hospital, but did receive a prescription for an EPI PEN. Patient reported that she felt a burning and tight sensation in chest, but that symptoms had gotten better when ambulance arrived.
This spontaneous report was received from a registered nurse concerning an unknown number of a patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M020926, expiry date: 11-AUG-2018) (lot # M031574, expiry date: 11-NOV-2018) (lot # M034894, expiry date: 11-NOV-2018), for prophylaxis (dose number and route of administration were unknown). The doses of RECOMBIVAX HB were stored between 32 Fahrenheit degrees and 36 Fahrenheit degrees (34.7 Fahrenheit degrees) for 48 hours. There was no previous temperature excursion and no data logger involved. No adverse effects were reported. Additional information has been requested.
Patient given vaccine on 07/15/2022. Vial expired 07/12/2022 based upon 10 weeks at fridge storage stability data.
Information has been received from a female patient, with no pertinent medical history and no drug allergies/drug rections, who on 26-AUG-2008 was vaccinated with a first 0.5mL dose of GARDASIL vaccine.  There was no concomitant medication.  The patient reported that on 27-OCT-2008 she experienced injection site pain after getting her second dose of GARDASIL vaccine.  No laboratory diagnostics studies were performed.  It was noted that she did not have any events after first dose.  The patient was not recovered.  The patient unspecified sought medical attention.  No further information is available.
A report has been received from a Health Professional concerning a patient, male subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 22-Jan-2014. The patient received expired FLUMIST. The outcome of the event of ADMINISTRATION OF EXPIRED DOSE is unknown. The report was considered to be non-serious by the reporter.
Pt fainted and fell after receiving his first covid vaccination. Pt was observed for 30 mins after before being released to go home. Water was provided to pt and he felt fine afterwards. Pt stated he must been dehydrated after a long day of work and felt fine after having some water and rest. Pt was followed up the next day (8/10/21), he was doing fine and very appreciative with the follow up check.
Headache, Myalgia, Arthralgia, Fever, Diarrhea, fatigue Narrative:
Edema, warmth, erythema and pain. Left deltoid <24 hrs after vaccines.
Patient had flu-like symptoms, shivering, fever, fatique, upset stomach as expected, but also complained of a bad cough about 24 hours after the shot that resulted in some blood being expectorated.
Patient, age 39, states 7 weeks ago (4/11/21) he received the second Covid vaccine in the right arm. The day after he felt expected malaise and stayed home from work. Day 2-3 it felt sore and warm. It began  bothering him more than expected a week later.  He describes it as being achy, weak, and sore. 3/10 pain. Denies losing sensation or having numbness. It's hard to pick up a cup of coffee. He can do pretty much everything he did before with this arm but lift weights. He hasn't lifted weights due to the pain, but not weakness. Denies any other symptoms. He controls pain with ibuprofen or aspirin. Patient denies any other illnesses around this time. Patient hasn't received any other vaccines around this time. Patient denies any previous adverse reactions from vaccines.
Event occurred after 3rd vaccine (no lot number listed in Immunization registry); breakthrough case admission
This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medication, drug reactions or allergies was provided. On 09-SEP-2015, the patient received an unspecified dose in immunization series for (Oka-Merck) PROQUAD (dose and route of administration were not reported) that was improperly stored. While lot # for adminsitered dose was not specified by reporter, lot # may include: L023113 with expiration date 24-DEC-2016, lot # L008355 with expiration date 11-SEP-2016, lot # L019995 with expiration date 02-DEC-2016 or lot # L019994 with expiration date 02-DEC-2016. No adverse effects were reported. Additional information has been requested.
The symptoms were first noticed in February 2022 but may have been present for longer. The primary symptom is numbness in both feet and a tingling sensation up both legs to just below the knee. I went to Hospital Emergency room on 2/27/2022 because all of a sudden the numbness and tingling traveled up by body and into my face. They did blood work for T4 free, magnesium, a basic metabolic panel, CBC w/auto differential, ecg 12-lead, reflexive urine culture, Urinalysis with reflex to microscopic, CT head without contrast, US Arterial Duplex Leg-Bilateral. Other than Highly sensitive TSH, the results were all negative. I was discharged and referred to a neurologist.  My first visit was ordered 4/07/2022 extensive blood work which will be identified in item 19. He also performed or ordered several diagnostic tests to be addressed in item 19.  On 6/28/2022 I was again seen in the Emergency Room at Hospital with similar symptoms of numbness and tingling traveling up from my legs into the rest of my body. They tested for TSH (highly sensitive 5.96), Lyme IGG and IGM with reflex to Elisa, Malaria smear, c-reactive protein, Sedimentation rate, automated, comprehensive metabolic panel, CBC w/ auto differential. The Sedimentation rate was slightly elevated at 40. ABS Lymphocytes Auto were slightly low at .91. White blood cell count slightly low at 3.6. BUN/Creatinine Ratio slightly high at 29.
Erythema at injection site. Pain at injection site (mild 1/10 scale).
Tingling,right, sore, numb up and down left arm down to the fingertips. It?s constant. If my arm is in a certain position, my hand becomes numb, tight, tingling as well. Started happening right after the second dose.
I woke up 5 days later with severe pain in my neck and upper back, headache. Numbness and tingling in my hand and feet . Ringing in my ears.
After getting the vaccine about 20 in later loose stools, then became progressively weak and sore throughout the day. In the evening running a high fever with severe pain throughout my body. The covers were even hurting. Unable to walk to the bathroom by myself. Slept 17 hours with high fever even with taking  fever reducing meds. Still running a fever of 101.7 this am, two days later. Unable to eat due to food making me feel sick to my stomach. Sore arm and a rash appeared near vaccine site today.
Double ear infection; Mild bronchitis; This is a spontaneous report from a contactable consumer via the Pfizer-sponsored program Pfizer. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 002191), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient received her first dose of the vaccine and is scheduled for her second dose on Friday (unspecified date). On an unspecified date, the patient was diagnosed with a double ear infection and mild bronchitis and was given penicillin in shot form and is on a Z-Pak. The patient asked if it okay that she gets her second dose as scheduled or if she needs to wait until she is done with her antibiotics. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Erythema multiforme, most likely secondary to varicella given on 12/09/2002. P/C from mom on 12/13/2002 c/o dry patchy rash on trunk of body. Tx with hydrocortisone 17 % cream. 12/17/2002 pt seen Tx Benadryl 1/3 tsp QID. 12/20/2002 seen again- Lubriderm: hydrocortisone pwd. mix 201/2 % concentration BID-TID
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 06Nov2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 14May2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jul2022, outcome "unknown", COVID-19 (medically significant) with onset Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Negative, notes: after 5 days of negative; (Jul2022) Positive, notes: Sick again 5 days later testing positive; (Jul2022) Positive, notes: Still positive day 4. Therapeutic measures were taken as a result of covid-19.  Clinical Course: Patient previously received a COVID-19 Vaccine. Patient was not taking any other medications within 2 weeks of starting COVID-19 treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
day following vax pt had a tactile fever, was fussy, and had 2 large swollen lumps (probably lymph nodes), tender to touch; pt to clinic, right inguinal area w/3cmx1/2-1cm wide lymph node, mobile, tender; left inguinal area 3cm width nonten
Next few days after shot, skin inflamed, warm and sore. As of last Friday (Sept. 17, 2021) a rash that show inflamed and sever itching appeared. Looks and acts like shingles. On way to my doctor now.
The morning Following the vaccine I woke up with loud roaring in right ear, over the next few days I noticed significant hearing loss in right ear only. Addressed this with my family pcp and was referred to ENT for evaluation.  Initial ENT appointment diagnosis was Unilateral Sensineural Hearing loss of the right ear after several audiology tests as well as physical exam. Prescribed a high dose steroid treatment for 10 days and follow for retesting.  Next appointment showed no improvement. Dr. then tried a series of 3 steroid tympanic injections also with little to no improvement with the hearing loss. MRI was ordered and results were normal.
Rash occurred starting 10 days after vaccine: Red, itchy arm, warm to touch, swelling. lasted about 3 to 5 days then went away.