chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient rec'd 3rd HPV on 4-25-17. Wednesday 4/26 he C/O sore arm and injection site hard and warm to touch. Thursday 4/27 continues to be sore, hard and warm to touch at site. C/O HA (headache) and picked up from school because congested and cough and sore arm. Encouraged to give him TYLENOL or an anti-inflammatory. PC 5/1/17 Arm pain resolved after the weekend.
w/in 4 hrs of receiving vax pt became increasingly pale, lips turned blue, did not respond to stimuli, condition lasted only a short time; color was returning by time pt was seen by MD;
5 days after vaccination,and on the day of TB skin testing, approximately 7-8 hours later, developed body aches, feverishness, feeling nauseated, hot. Didn't take temp, didn't seek medical care, no meds.Symptoms resolved spontaneously the next day.
soreness progressed through the day. red and swollen, no itching. by 2nd day very painful, shoulder to elbow, red and swollen inner half arm shoulder to elbow. lasted a week before total cleared up
Slight shoulder pain around injection sight; Mild discomfort; This is a spontaneous report from a contactable consumer (patient). A 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK4176; Expiration date was not reported) on 22Jan2021 (10:15) at a single dose, with route of administration unspecified, for COVID-19 immunization at the workplace clinic. The patient's medical history and concomitant medications were not reported. On 22Jan2021 (12:30), the patient had slight shoulder pain around the injection "sight" (site) and mild discomfort. The pain around the injection site had lasted roughly 48 hours, and then was getting more painful over time, then slowly getting better. The patient did not receive any treatment for the reported events. The outcome of the events, pain around the injection site and discomfort, was recovered in Jan2021. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Muscle aches, chills, pain at injection site; Muscle aches, chills, pain at injection site; Muscle aches, chills, pain at injection site; This is a spontaneous report from a contactable nurse, the patient. A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Ek9231) solution for injection intramuscular in the left arm on 26Dec2020 at 10:30 (at the age of 23-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history and concomitant medications were unknown. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 27Dec2020 at 01:00, the patient experienced muscle aches, chills, and pain at injection site. No treatment was provided for the events muscle aches, chills, and pain at injection site. The outcome of the events muscle aches, chills, and pain at injection site was recovering. Since the vaccination, the patient has not been tested for COVID-19.
This is a spontaneous report from a contactable consumer (patient).  A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3246, via an unspecified route of administration in the left arm, on 14Jan2021 08:30 at SINGLE DOSE for covid-19 immunization.  Medical history included penicillin allergy. 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 hasn't been tested for COVID-19. Concomitant medications included loratadine (CLARITINE), ascorbic acid (VIT C), vitamin b complex and ergocalciferol (VIT D).  On 21Jan2021 13:00, exactly 7 days after receiving 1st dose, the patient developed shingles. The outcome of event was recovering. The patient received Valacyclovir HCL 1 G as treatment for the event. The event was considered as non-serious by the reporter.  No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.
No additional adverse event; incorrect product storage; This spontaneous report was received from a nurse referring to a 7 months old male patient. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.  On 16-JUN-2020, the patient was inadvertently vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # S030966, expiration date was 14-APR-2022) (exact dose and route of administration were not reported) for prophylaxis (product storage error). The administered doses experienced a temperature excursion of 35.2 degrees Fahrenheit (F) for 42 minutes. There were no previous temperature excursions. The temperature excursions were detected by a data logger. No additional adverse event.
This initial spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on unspecified dates, the patients were administered an unspecified number of improperly stored doses of M-M-R II injection (lot# reported as L000459 with expiration date 06-JAN-2017 and lot# L008684 with expiration date 13-MAR-2017; albumin status, dose and route were not provided). No adverse effects were reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Started having difficulty breathing and severe breathing when stressed early September. Taken to Emergency Room at Hospital, Sept. 7 with O2 sats in the 80's.  Was in ER for multiple tests to determine cause of breathing issue. Scan and blood tests ultimately revealed massive clotting in lungs and heart. Put on IV Heparin and hospitalized for 1 week.
The shot was given on the evening of the 26th and on Monday the 30th, patient had a grand mal seizure as he was entering his school. He was rushed to the Hospital by ambulance. He did not regain consciousness until he was half way to the hospital. We estimate he was unconscious for about 10-15 minutes. He was given a CAT scan, blood was taken, and an appointment at Medical Center was made for the same day. We met with the neurologist at 1:00 on the same day as the seizure. An EEG was ordered and found to be abnormal. He was then given an MRI and MRA with contrast. These tests were normal. He is now on Ethosuximide twice a day.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 18-NOV-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (VIs 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) dose, route and anatomical location were not provided. There was no concomitant medication provided. On an unknown date, the PNEUMOVAX had a temperature excursion for 1800 hours, the highest recorded temperature was 59.9 F (15.5 Celsius). The vaccine status was reported as "in excursion", and was storage in a Refrigerator (R). There was no product quality complaint involved and no adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.
Patient received two vaccines in left arm on 10/4/2020 . Patient states to have pain in left arm still to this day. Went previously to prescribers office and received medication for pain, but insist to have pain when laying down on that arm and when raising arm at a certain angle. Patient mentioned he will be attending his doctors office for second time this upcoming week.
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 61-year-old male patient received BNT162b2 (BNT162B2), on 29Jul2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 05Jan2021 as dose 1, single (Batch/Lot number: unknown), on 02Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Open heart surgery for bicuspid aortic valve replacement" (unspecified if ongoing); "hypertrophic cardiomyopathy" (unspecified if ongoing); "pacemaker/difibrillator" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: WARFARIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". 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.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
both of her arms turned yellowed; This is a spontaneous report from a contactable pharmacist via a medical information team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACINE and Batch/Lot Number: ER8731, Solution for injection) via an unspecified route of administration on 15Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was stated she received the first dose of the Pfizer covid vaccine on 15Apr2021 and both of her arms turned yellowed on same day. Reporter considered events as non-serious. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
Right arm red mark half the size of your palm, hot to the touch and raised where vaccine was given. Called the pharmacy and they said it?s Covid Arm and to ice it and it should be back to normal within 24 hours.
Fever up to 102, aches, pains, headache, fatigue, loopy feeling g
Patient came with some welps on her hand & face, and a picture of her face swollen. She said the symptoms started the evening after taking the FLUVIRIN injection. She was treated at the ER & followed up with PCP - injection administered about 11:30 AM.
Swelling of the deltoid area uniformly formed, no isolated mass. (Immunization given on 8/4/14, mom reported to us on 8/6/2014.)
Started out like an extreme case of flu. I was very pale, ached all over, had a headache that wouldn't quit and every bone in my body hurt. When I talked to the doctor, she looked at me and said that it was a perfect case of the reaction to the vaccine and this lasted for about 36 hours. After about 36 hours, I felt as good as new.
Quizzy, light headed (stumbled at one point), intense nausea,flushed (felt like had a fever), sore throat. No anaphylactic shock, no shortness of breath, afebrile, 154/96, pulse 92 & reg.
VACCINE ERROR, ADMINISTERED AFTER AVAIABLE DATE TO BE USED. NOTIFICATION OF PFIZER BIVALENT TO END RECEIVED 9.12.23LATER AFTERNOON.
Noticed a stinging, burning rash on face under left eye, on the side of my nose, and on upper lip on 03/28/2021 at 11:00 AM. 03/31/2021 Was seen by Dr. . He diagnosed the rash as shingles.  Prescribed Valacyclovir 500mg tabs. 2 tabs 3 times daily for 7 days.
body aches; chest pain; pressure on chest; low fever; cold; tested positive for covid 19; This is a spontaneous report from a contactable consumer report for self from a Pfizer sponsored program Covax US Support. A 62-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 10Apr2021 16:30 (Batch/Lot Number: EW0158) as single dose for covid-19 immunisation. No additional vaccines administered on same date of the Pfizer suspect. No prior Vaccinations within 4 weeks. Medical history included ongoing high blood pressure started 8-9 years ago. Concomitant medications included lisinopril (LISINOPRIL) taken for high blood pressure about few years; acetylsalicylic acid (BAYER ASPIRIN) taken to keep the blood thin and blood pressure; Carvedilol taken for heart valve, something to do with his heart since couple years ago. Patient received his first vaccine dose on 10Apr2021 and on 11Apr2021 tested positive for covid 19. He was at Emergency Department on an unspecified date. He went because he had body aches, chest pain, pressure on chest, once in a while had low fever, cold, and achy body. He was given a treatment, but doesn't know the name of what was given. It was through the Intravenous site. Patient no longer has symptoms and has completed his required isolation. He is due to get his second vaccine dose on 01May and asked do he get second dose or should wait. The outcome of events was unknown.
erythema at injection site extending into her left shoulder, with edema developing at  from site to left collar bone
Redness and swelling of left upper arm. Size: 6cm by 7.5cm.
This case was reported by a physician via call center representative and described the occurrence of headache in a 19-year-old male patient who received BEXSERO. In January 2016, the patient received BEXSERO. In January 2016, 3 days after receiving BEXSERO, the patient experienced headache, dizziness and fatigue. On an unknown date, the outcome of the headache was not recovered/not resolved and the outcome of the dizziness and fatigue were recovered/resolved. It was unknown if the reporter considered the headache, dizziness and fatigue to be related to BEXSERO. Additional details were provided as follows:  The patient was grandson of the reporting healthcare professional. The healthcare professional reported that the patient received BEXSERO 2 weeks before the time of reporting and began experiencing headache, fatigue and dizziness 3 days after receiving the vaccine. The healthcare professional reported that the patient has never experienced these types of symptoms before. The healthcare professional reported that the symptoms seemed to go away a few days before the time of reporting but the headache has come back. No further information was reported regarding this administration. The healthcare professional initially called for recommendations of clinical data regarding adverse reactions of BEXSERO. The call was escalated to Vaccine's Medical Information System.
poor oral intake .  Seizures.   on admission she was found to have lactic acidosis. Transaminase elevation and thrombocytopenia and Cr of 1.2
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 25-JUL-2017 the patient was vaccinated with VAQTA lot # L023232 for prophylaxis. On 25-JUL-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event. Sender's Comments: US-009507513-1709USA003130: US-009507513-1709USA003272.
Pt recvd DTP/HIB/OPV pt cried from 1130AM until 5PM screaming, t99, Tempra given x 2; legs swollen @ site of inject;
At 5:00 on 9-17-12 - pt c/o itching, increase redness. On 9-18-12 in am increased redness (3") increase itching, pain and edema. Wheal increased in size. Denies fever, body aches etc. On 9-18-12 contacted office and orders given to take OTC Benadryl 25 mg and ice pack. On 9-19-12 - contacted pt redness, itching, edmesa and pain had improved - wheal remains. On 9-20-12 improving with s/s.
Pt vaccinated with MMR/DT developed diaphoretic, faint, nausea, increased pulse rate, weakness occurred 5 min after MMR given. Lasted 15 min. then pt started to feel better.
Approx 20min after vaccination, patient developed itching local to vaccination area. Treated with 25mg Diphenhydramine.
1 1/2hr p/vax pt had n/v & bad h/a;went to ARNP that day;given pain rx & rx for n/v;c/o feel like has had flu even since got vax;n/v daily, aches, all over, arm hurts where vax given;blister on it & still red;
Confusion regarding the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Confusion regarding the vaccination site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Confusion regarding the vaccination site). At the time of the report, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Confusion regarding the vaccination site) outcome was unknown.            No concomitant products were reported. No treatment information was reported.   This case was linked to MOD-2022-539724 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2022: Follow-up received contains no new information.
This spontaneous report as received from other health professional refers to a patient of unknown age. On 12-NOV-2014 the patient was vaccinated with 4th dose of GARDASIL 0.5 ml, intramuscular. No adverse effects were reported. Product quality complaint was reported. The outcome of events was unknown. Additional information has been requested.
Nausea; BP 183/89 (pulse 87), O2 sat 98%. F/u BP 164/78 (pulse 87).
Hard pounding heartbeat that is not irregular or fast; dizziness; exhaustion; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 28Apr2021 at 12:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included Graves' disease, but the patient was in remission since 2018. The patient had no known allergies. Concomitant medications included daily supplemental vitamins (MANUFACTURER UNKNOWN), taken for an unspecified indication for an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on 01Apr2021 at 10:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. 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 30Apr2021 at 22:00, the patient experienced hard pounding heartbeat that was not irregular or fast, which seemed to be causing dizziness and exhaustion. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events hard pounding heartbeat, dizziness and exhaustion were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Bronchospasm, arthralgia, fever, vomiting x 6, started 4 days after vaccine resolved in 2 days.
Information has been received from a physician concerning a 4 1/2 month old male who was vaccinated with 2 doses of COMVAX (Lot #657380/0377U is for the first dose).  24 hours after receiving the first dose the patient developed redness and swelling at the injection site and it was hard.  When the patient received the second dose of COMVAX he experienced the same adverse event.  The lot number for the second dose was not provided but the physician mentioned it was not one of the recalled lots.  The patient sought medical attention.  Outcome is unknown.  Additional information has been requested.
Progressive muscle weakness, symptoms consistent with GBS however deemed that it was not GBS or any other known neurological or autoimmune condition
At about 9:30 I was looking at my phone. My vision started going blurry. I started seeing flashing lights and could not be around any light. I went to a dark room and about 30 minutes later it stopped where a wasn't seeing a flashing line.  I took melatonin and went to bed figuring I was starting to get tired.  I woke up at 638am. Arm super sore, a red spot over the size of a quarter at injection site. Low grade 99.1 and my entire body hurts and a small headache. Called in to work to rest for the day.
Renal failure; periodic uncontrollable shaking; This is a spontaneous report from a contactable consumer. A 94-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Feb2021 12:00 (Batch/Lot number was not reported) (at the age of 94-years-old) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history was none, she was just old. There were no known allergies. The patient did not get covid prior vaccination. There was no other vaccine in four weeks. Concomitant medications in two weeks included temazepam; ascorbic acid, calcium, minerals nos, retinol, tocopheryl acetate, vitamin b nos, vitamins nos, zinc (CENTRUM SILVER); ascorbic acid, retinol, tocopherol (OCUVITE) all taken for an unspecified indication, start and stop date were not reported. The patient experienced renal failure and periodic uncontrollable shaking on 24Feb2021 13:00. The events resulted in doctor or other healthcare professional office/clinic visit. There was no treatment received. The outcome of the event periodic uncontrollable shaking and renal failure was unknown. Covid was not tested post vaccination.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Since GARDASIL 9 was administered 10 days ago, the patient had a sore arm, swelling at injection site and supraclavicular lymph node swelling; Since GARDASIL 9 was administered 10 days ago, the patient had a sore arm, swelling at injection site and supraclavicular lymph node swelling; Since GARDASIL 9 was administered 10 days ago, the patient had a sore arm, swelling at injection site and supraclavicular lymph node swelling; This spontaneous report has been received from a nurse via a company representative, concerning a 16 year old female patient.     The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, anatomical location, lot number and expiration date were not reported) for prophylaxis  On 14-JUL-2019 (also reported as "since 10 days ago"), after hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was administered, the patient had a sore arm (injection site pain), swelling at injection site (injection site swelling) and supraclavicular lymph node swelling (lymphadenopathy). At the reporting time, she had not recovered from all the events.   The causal relationship between all the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.