chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant via a company representative refers to a 15 year old male patient. The concurrent condition, medical history and concomitant medication was not reported. On 08-APR-2016, the patient was vaccinated with third dose in the series of GARDASIL 9 (lot # L019297). Approximately 20 to 30 minutes later, the patient had a tuberculosis test. When the patient went to the checkout counter in the medical office, he fainted. The patient had no injuries. His legs were kept elevated and he was given juice and crackers. He was reported to be fine at the time of report and needed no follow up. The medical assistant also reported that the patient had no reactions to the prior doses of GARDASIL 9. Additional information is not expected as the reporter did not wish to be contacted.
Soreness of site for several days after injection to include a rash that started the day after lasting through today 11/25/2021
Right upper thigh up to right inguinal area; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 08:30 (Lot number: fwo153) at the age of 32 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "diabetes type 1" (unspecified if ongoing); "major depressive disorder" (unspecified if ongoing); "ADHD" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL; CELEXA [CELECOXIB]. Past drug history included: Nitrofurantoin, reaction(s): "Known allergy- nitrofurantoin".  The following information was reported: GROIN PAIN (non-serious) with onset 16Apr2021, outcome "recovered" (2021), described as "Right upper thigh up to right inguinal area". Therapeutic measures were not taken as a result of groin pain.  Additional information: Patient had no COVID prior to vaccination. Patient was not tested for COVID post vaccination. Patient had no other vaccine in four weeks. Patient had other medication in two weeks: adderall and celexa.  No follow-up attempts are possible. No further information is expected.
Within 12 hours, 103 fever, vomiting, migranes.  Lasted 3 days. Within 4 days, joint pain (fingers, hands, wrists, ankles, hips, knees.  This lasted a week.  It now flares up every 7-10 days.  I can't lift groceries, can't do push ups, can't do yoga.  My wrists and fingers especially swell. By next menstrual cycle (9 days later) and continuing menstual cycles since 4/21/21, extremely heavy periods with a lot of pain in lower abdomen near ovaries.  Periods so heavy that I am unable to leave the house for the first 2 days.  This has never been the case since my first period in 1994.
Pt is just 17 years old and received Moderna he should have received Pfizer based on his age.  He has not had any adverse affects from error.
when woke up this morning had a rash on her left buttocks, left side of her back and on her right side of her body (starting about the rib cage) had a red streak.
RAPID HEART BEAT; FEELING OUT OF BREATH; CHEST DISCOMFORT; SWEATING; CHILLS; FEVER; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-MAR-2021, the subject experienced rapid heart beat. On 06-MAR-2021, the subject experienced feeling out of breath. On 06-MAR-2021, the subject experienced chest discomfort. On 06-MAR-2021, the subject experienced sweating. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, chills, and fever, and had not recovered from rapid heart beat, feeling out of breath, and chest discomfort. This report was non-serious.
Left Arm swollen, red , orange from inside; Red blotches on left arm with hurting of arm at injection site.; Burning in stomach; Red blotches on left arm with hurting of arm at injection site; Burning in chest; Difficulty in breathing; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Left Arm swollen, red , orange from inside), RASH MACULAR (Red blotches on left arm with hurting of arm at injection site.), CHEST PAIN (Burning in chest), DYSPNOEA (Difficulty in breathing) and DYSPEPSIA (Burning in stomach) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 040AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced CHEST PAIN (Burning in chest) and DYSPNOEA (Difficulty in breathing). On 15-Mar-2021, the patient experienced PERIPHERAL SWELLING (Left Arm swollen, red , orange from inside), RASH MACULAR (Red blotches on left arm with hurting of arm at injection site.), DYSPEPSIA (Burning in stomach) and VACCINATION SITE PAIN (Red blotches on left arm with hurting of arm at injection site). At the time of the report, PERIPHERAL SWELLING (Left Arm swollen, red , orange from inside), RASH MACULAR (Red blotches on left arm with hurting of arm at injection site.), CHEST PAIN (Burning in chest), DYSPNOEA (Difficulty in breathing), DYSPEPSIA (Burning in stomach) and VACCINATION SITE PAIN (Red blotches on left arm with hurting of arm at injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant products included CHOLESTEROL medication. Patient took Inhaler couple of times for burning in chest and difficulty in breathing.   This case was linked to MOD-2021-059394 (Patient Link).
Right arm immediately went numb down its length and immediately noticeably swelled up, from wrist to shoulder. It was hot to the touch. The arm also developed a rash. Patient was monitored by paramedics, who confirmed her pule, oxygen levels and blood pressure were normal. Conditions improved after about a half hour, but did not resolve completely. Arm is still slightly swollen (after providing Benadryl) and is very painful around injection site, 24 hours later..
Information has been received from a physician concerning a patient who was vaccinated with oral ROTATEQ at one week of age. No product quality complaint. Additional information has been received from a nurse indicating that the 5 day old female was given 1 pouch of ROTATEQ on 06-AUG-2008. The patient has shown no adverse effects. She has been seen by the office twice since receiving the ROTATEQ on normal well baby visits and had no symptoms or problems. Additional information has been requested.
developed rash 3 hours after receiving vaccine, consistent with erythema multiforme, persistent
ON A VENTILATOR; This spontaneous report received from a consumer via social media via a company representative concerned a patient of unspecified age, sex, race and ethnicity. 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 and expiry date: unknown) dose, start therapy date were not reported 1 in total administered 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, following vaccination, the patient was put on a ventilator. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of on a ventilator was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210523218-covid-19 vaccine ad26.cov2.s -On a ventilator . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Pt felt nauseated and dizzy after the Janssen vaccination; pt was sitting in the observation area and confronted by RN; pt placed on gurney to be evaluated; vitals taken q5 mins; pt relieved of nausea and dizziness after consuming nutrients and fluids (240ml of apple juice, 240 ml of water); Vitals:   10/06/21 0823 10/06/21 0830 10/06/21 0835 BP: 124/77 100/60 115/74 BP Patient Position: SITTING SITTING STANDING BP Location: RA-RIGHT ARM RA-RIGHT ARM RA-RIGHT ARM Pulse: 84 85 89 Resp: 18 18 18 Temp: 97.2 °F (36.2 °C)   97.2 °F (36.2 °C) SpO2: 98% 97% 99% Height: 5' 3" (1.6 m)   5' 3" (1.6 m)
After patient's 2nd COVID vaccine she had symptoms of stabbing, burning and cramping.  Patient has undergone many tests and has worked with a chiropractor, pain management.  She does report intermittent tingling, numbness and burning.  She has had difficulty with sleeping through the night as symptoms do wake her up in the middle the night.  She does find it hard to fall sleep after waking up due to the symptoms.  She has tried multiple medications including tramadol, Flexeril, ibuprofen, Tylenol and naproxen.  Patient has also been referred to specialists including  neurology.  She does continue to follow with Psychiatry  for history of anxiety and depression.   She did recently start working with occupational therapy.
Client received second injection on 3/4/2021.  Client had no adverse reactions to the first vaccine.  On 3/8/2021, 4 days post second vaccination experienced diaphoresis, lightheadedness, intermittent heart palpations, fatigue.  Client stated slept majority of the day and woke up with no side effects the next day.  Instructed client to contact PCP to inform of possible side effections to vaccination.
Fever; Sore throat; This is a spontaneous report from a non-contactable consumer, the patient. A 25-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183) via an unspecified route of administration on 13May2021 (at the age of 25-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in May2021 ,8 hours after the shot, the patient experienced fever for about 60 hours and when fever was gone, the patient developed sore throat. The clinical outcome of the event fever was recovered on an unknown date in May2021; while that of sore throat was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Treatment of COVID-19/ Positive test; Treatment of COVID-19/ Positive test; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years 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's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "unknown", COVID-19 (medically significant) with onset May2022, outcome "recovering" and all described as "Treatment of COVID-19/ Positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: Rebound COVID (Symptoms + Positive test). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Adverse event: Rebound COVID (Symptoms + Positive test), Adverse event start date on 14May2022; anti viral details: treatment was Paxlovid from 09May2022 to 12May2022, Indication: Treatment of COVID-19, Administrator route: Oral.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
About two weeks ago I noticed my left testicle swollen. I am a cancer survivor. I am subject to UTI's. I am on a two-week course of an antibiotic. I take them morning and night.
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 patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 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.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. The patient received Shingles vaccine but still got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Patient states inflammatory reaction requiring hospitalization; leg pain could not lift leg or walk; leg pain could not lift leg or walk; Swelling in joints; pins and needles feeling; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 18Jan2022 09:30 (Lot number: Fj5682) at the age of 63 years as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLAMMATION (hospitalization) with onset 23Jan2022, outcome "unknown", described as "Patient states inflammatory reaction requiring hospitalization"; PAIN IN EXTREMITY (non-serious), GAIT INABILITY (non-serious) all with onset 23Jan2022, outcome "unknown" and all described as "leg pain could not lift leg or walk"; JOINT SWELLING (non-serious) with onset 23Jan2022, outcome "unknown", described as "Swelling in joints"; PARAESTHESIA (non-serious) with onset 23Jan2022, outcome "unknown", described as "pins and needles feeling". The events "patient states inflammatory reaction requiring hospitalization", "leg pain could not lift leg or walk", "leg pain could not lift leg or walk", "swelling in joints" and "pins and needles feeling" were evaluated at the physician office visit.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the serious event and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Dizziness with first dose of Pfizer-BioNTech COVID-19 vaccine 0.3 mL IM in left deltoid. Monitored vitals, which remained stable. Patient thought it was more of a mental effect because of something that a friend told her about the vaccine. Patient was reassured and when she felt better, was released back to work.
I had a slight cough, mild fever 102F, fatigue, some diminished mental focused, fuzzy thinking. I used a home COVID-19 test, that came back positive. Both my wife and I were positive, we discussed our symptoms, he asked that we test our oxygen. He said that it was good, if it did go lower to contact him and let him know the numbers. We took over the counter medication and used throat lozenges. Within ten days the symptoms decreased, the fatigue has lingered coming and going but not as strong, my thinking can be fuzzy at times. As time goes on, everything is getting better, I am just very aware of the fuzzy thinking as it is not me.
Headache; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EN6206) via an unspecified route of administration in the left arm on 07Mar2021 at 08:00, (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient did not take any concomitant medications. The patient had no known allergies to medications, food or other products. 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. On 17Mar2021 at 14:00, the patient experienced headache. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event of headache was recovered on an unknown date in 2021. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: ER8733) via an unspecified route of administration in the left arm on 28Mar2021, (at the age of 56-years-old), as a single dose for COVID-19 immunisation.  No follow-up attempts are possible. No further information is expected.
Information has been received from an office manager concerning "a patient of theirs told her that her daughter was diagnosed with 'parvo' after receiving her third dose of GARDASIL, 0.5ml, IM". "Her (the patient) family has a history of lupus." The consumer is not a patient at this practice. The patient sought unspecified medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
I experienced high fever, body aches, nausea, diarrhea and back pain.
This spontaneous case reported by a consumer, describes the occurrence of pyrexia (fever) and dyspnea (difficulty breathing) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concomitant products included Eliquis (apixaban). On Sep 9, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 10, 2021, patient experienced pyrexia (fever). On Sep 15, 2021, patient experienced dyspnea (difficulty breathing). On Sep 11, 2021, pyrexia (fever) resolved. At the time of the report, dyspnea (difficulty breathing) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No treatment medication reported.
Chronic dry mouth; Dry nasal passages; Lacks ability to smell; Lacks ability to taste; Has not had a good meal in about 4 weeks; 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), administration date 05Jan2022 (Batch/Lot number: unknown) 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: DRY MOUTH (non-serious), outcome "unknown", described as "Chronic dry mouth"; NASAL DRYNESS (non-serious), outcome "unknown", described as "Dry nasal passages"; HYPOSMIA (non-serious), outcome "unknown", described as "Lacks ability to smell"; HYPOGEUSIA (non-serious), outcome "unknown", described as "Lacks ability to taste"; DECREASED APPETITE (non-serious), outcome "unknown", described as "Has not had a good meal in about 4 weeks".  Additional information: Clinical course: It was reported that patient got his first shot on 05Jan2022 since then, he has had chronic dry mouth, and dry nasal passages. He still lacks smell or taste. Overnight his mouth feels dry, like there is dirt in his mouth, and his nasal passages are dry. Patient wants to know if these symptoms will continue and will they go away and anyone else reported these events. Patient was supposed to get his second shot today and the nurse at the vaccine site could not answer his question. He may not get his second shot and has not had a good meal in about four weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt was admitted to hospital from the ED on 4/18/21, over 2wks after 2nd dose of vaccine. Per guidelines, all hospitalizations should be reported
no ability to stand or walk; difficulty sleeping; EXTREME back pain; This is a spontaneous report received from Pfizer. A contactable consumer reported for his wife (patient) that. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection) 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 concomitant medications were not reported. It was reported that reporters wife has been suffering from what we believe to be an extreme reaction to her 1st Pfizer vaccine dose. She had reported it to the VAERS site with no response or follow up from them. Her symptoms include almost no ability to stand or walk, difficulty sleeping and EXTREME back pain. Reporter took her to the ER and she had a night in the hospital. It had been 10 days. Outcome of the events was unknown.   Information about lot/batch number has been requested
2nd monovalent dose was given 3/15/2023. Bivalent dose, given 4/19/2023, was given too early.
Pain and fever in the site injection area.  This continues to this day.  Soreness. Inability to push up from a sitting position with my left arm/hand.  Pain that runs down my arm.  I have to take my right hand to move my left arm.   I just had pains that caused me to lose control of my left arm...left arm slid off the arm of my chair.  These pains have been extreme today...continuously.  I am really concerned as I had no pains with the first shot...a little soreness that was completed gone by the third day.  The second shot was/is still painful.
5 days after the vaccination, patient experienced painful lymphadenopathy to left side of neck.  She also had some tingling sensations to the area. Patient was seen in the office on 4/9/19, when she was prescribed AUGMENTIN and prednisone. Patient called office on 4/16/19 and reported that the lymph node is decreasing in size, and is no longer painful. She is no longer experiencing  tingling in the area.