chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 3 year old male with latex allergy and a history of urinary bladder atrophy with multiple procedures who was vaccinated with the mumps virus vaccine live in approximately March 2004, the patient developed an anaphylactic reaction within minutes of receiving the vaccine with tingling of the tongue, vomiting and hives. He was given epinephrine and diphenhydramine hydrochloride in the office. He then experienced a laryngospasm and a croupy cough. The patient went to the emergency room and received another dose of epinephrine. Subsequently, the patient recovered from the anaphylactic reaction. The reporter felt that the anaphylactic reaction was related to therapy with the mumps virus vaccine live. The anaphylactic reaction was considered to be immediately life threatening. Follow up on 05/24/04 states: "On 04/16/04 an allergen skin test result was positive for a class 3 rash. The reporting physician stated that the mumps vaccine and gelatin were positive in triggering the generalized urticaria. The reporter felt that the anaphylactic reaction was related to therapy with the mumps virus vaccine live. The anaphylactic reaction was considered to be immediately life-threatening. This report no longer meets criteria for submission because the unexpected adverse experience of 'laryngospasm' has been deleted."
I was admitted to the hospital at 37 weeks pregnant for planned induction of birth.  The induction process failed and approximately 36 hours into labor a c-section was performed.  The aspect in question about whether or not it is related to having had the 1st dose of the COVID-19 vaccine was that I hemorrhaged 2 times after the c-section which lead to multiple blood transfusions and almost put me in the ICU.  Could the vaccine have contributed to increased bleeding?
PEELING AND FLAKING ON SCALP, LEFT SIDE AND LOWER BACK; BUNCH OF LITTLE SPOTS; PSORIASIS FLARE; ITCHING ALL OVER BODY; FELT MORE WEAK; This spontaneous report received from a patient concerned a 56 year old female. The patient's weight was 170 pounds, and height was 64 inches. The patient's past medical history included psoriasis, weak bronchial artery in lung, pre-chronic obstructive pulmonary disease, and asthma, and other pre-existing medical conditions included no known allergies and on antacids medications. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced felt more weak. On 26-MAY-2021, the subject experienced itching all over body. On 29-MAY-2021, the subject experienced psoriasis flare. On an unspecified date, the subject experienced peeling and flaking on scalp, left side and lower back, and bunch of little spots. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine was not applicable. The patient was recovering from itching all over body, had not recovered from psoriasis flare, peeling and flaking on scalp, left side and lower back, and bunch of little spots, and the outcome of felt more weak was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment not required as the per standard operating procedure as the case is assessed as Non-serious.
Severe rash of hives on arms, legs, and buttocks; Severe rash of hives on arms, legs, and buttocks; Booster dose administered; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3589) via an unspecified route of administration in the left arm on 08Oct2021 at 12:15 (at the age of 67-year-old), as a single dose for COVID-19 immunisation. Medical history included allergy to alpha gal-meat. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) and acetylsalicylic acid (ASPIRIN), all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265) via an unspecified route of administration in the right arm on 27Jan2020 at 16:30 (at the age of 66-years-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the right arm on 17Feb2021 at 12:30 (at the age of 66-years-old); both as a single dose for COVID-19 immunisation. On 09Oct2021 at 00:30, the patient experienced severe rash of hives on arms, legs, and buttocks. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe rash of hives on arms, legs, and buttocks was resolved on 09Oct2021.
Within 2-3 minutes of the vaccines, baby was breast-feeding and body became limp and pale with shallow breathing. He also seemed to fall into a deep sleep according to parents. It took about 10-15 minutes for him to get color back and open his eyes. I personally evaluated him 25-30 minutes after vaccination at which time he was back to baseline with normal cap refill and cardiorespiratory exam.
Migraine, muscle aches, weakness and exhaustion. Felt 10x worse than i did when i originally had covid a month and a half ago
administered havrix after a temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 1-year-old male patient who received HAV (Havrix) (batch number 2K57N, expiry date 11th December 2022) for prophylaxis.   On 6th April 2022, the patient received the 1st dose of Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 15-Jun-2022 Reporter's comments: Medical assistant reported that the patient was administered with the Havrix vaccine after a temperature excursion in right arm. The consent to follow up was given. Additional Supportive Information: The patient was administered with the Havrix vaccine after a temperature excursion, which led to incorrect storage of drug. This was 1 of the 11 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022093643:Same reporter. US-GLAXOSMITHKLINE-US2022093637:Same reporter US-GLAXOSMITHKLINE-US2022093638:Same reporter. US-GLAXOSMITHKLINE-US2022093597:Same reporter. US-GLAXOSMITHKLINE-US2022093600:Same reporter. US-GLAXOSMITHKLINE-US2022093602:Same reporter. US-GLAXOSMITHKLINE-US2022093642:Same reporter. US-GLAXOSMITHKLINE-US2022093644:Same reporter. US-GLAXOSMITHKLINE-US2022093647:Same patient, same reporter, different product US-GLAXOSMITHKLINE-US2022093648:Same reporter.
This spontaneous report was received from a Registered Nurse referring to a 28 year old patient of unknown gender. No concurrent or historical conditions were reported. On unspecified dates, the patient was vaccinated with 2 doses of GARDASIL Lot number, expiration date, dose, route, and anatomical location were not provided. No concomitant medications were reported. The patient was vaccinated at the age of 28 years old (inappropriate schedule of drug administration). No adverse effect reported. No product quality complaint was involved. Additional information has been requested.
Used as treatment for multiple recalcitrant warts on his hands, back, and genital area; Information has been received from the authors in a published literature article, title as below, referring to a 40 year old male patient. The patient's medical history included heart transplant, in 2011.     On an unspecified date, reported as "during the previous 5 years", the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manfuacturer unknown), for multiple recalcitrant warts on his hands, back, and genital area (product use in unapproved indication).  The authors stated that the patient had been unresponsive to multiple treatments including  HPV vaccination.
Pt. received high dose flu vaccine 1 0.5 ml Lot# UI728AB exp. 6/30/17 in left deltoid 1/31/17. He then went to pharmacy to get PREVNAR 13 and was given Pneumo 23 in same arm same day. Now has reaction. Patient states he had reaction at 11:30 AM swelling redness left arm.
Swelling in both hands; This is a spontaneous report from a contactable consumer, a patient. A 69-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) on 10Mar2021 at 02:00 pm (at the age of 69-year-old) on right arm as a single dose for COVID-19 vaccination. Medical history includes heart condition from an unknown date. The patient had no known allergies. Concomitant drugs include Apixaban (ELIQUIS), Motropolo(MANUFACTURER UNKNOWN), Amiodarone(MANUFACTURER UNKNOWN) and Stain(MANUFACTURER UNKNOWN). Patient was not diagnosed with COVID-19 prior to the vaccination. Patient has not tested for COVID-19 since having the vaccine and did not receive any vaccine 4 weeks prior to COVID-19 vaccination. The patient experienced swelling in both hands on 15Mar2021.Therapeutic measures for swelling of both hands includes Script for steroid pack and Benadryl on an unknown date. The clinical outcome of swelling in both hands was recovered/resolved. Information about lot/batch number cannot be obtained. No further information is expected.
no additional AE's; temperature excursion / temperature 34.1 F; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, current conditions nor concomitant therapies provided.  On 18-JAN-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), dose/frequency reported as 1 (unit not provided), lot # 1687292, expiration date 25-AUG-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in temperature of 34.1 degrees Fahrenheit (F) for 4 hours and 15 minutes. Previous temperature excursions were reported as follows: 34.8 F for 45 minutes and 34.7 F for 2 hours and 45 minutes (dates not provided). Digital data logger was involved. The patient was reported to be asymptomatic, no adverse events (AE's) were reported.  This is one of several reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007278: US-009507513-2104USA007277: US-009507513-2104USA007276: US-009507513-2104USA007270:
Metallic taste; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 31-year-old female patient 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 21May2021 at 11:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic migraine, fibromyalgia, Hashimoto's, depression, essential tremor, anxiety, and post-traumatic stress disorder (PTSD), all from unknown dates and unknown if ongoing. Prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccines in four weeks. Concomitant medications included levothyroxine, duloxetine, ibuprofen, and vitamin D, all from unknown dates for unknown indications. The patient previously received codeine from an unknown date for an unknown indication and experienced drug allergy; and a flu shot on an unknown date for immunisation and experienced vaccine allergy. On21May2021 the patient experienced metallic taste 20 minutes after she received her shot; and reported it didn't go away regardless of what she did. No treatment was received for the events. The clinical outcome of metallic taste was not recovered. It was also reported that the patient had not been tested for COVID-19 since vaccination.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
COVID breakthrough. I had runny nose, burning sore throat, fever 101 degrees. I also had body aches, fatigue. The runny nose lasted 6 hours. The sore throat lasted an hour. The fever and muscle aches lasted 48 hours. The fatigue lasted 2 1/2- 3 weeks.
Patient's husband called stating that the patient had neck pain/ throat pain and they think they see the start of a red line.
The patient's daughter contacted me to let me know her Mother developed a rash on her left arm on 08/17/21.  She described it as non-itchy but does have blisters.  She stated the rash was on the upper portion of her arm as well as a small amount on the lower part of the arm.  I advised I would completed this report and that they should contact her doctor for medical advice.
Systemic: Dizziness / Lightheadedness-Medium, Systemic: Fainting / Unresponsive-Medium.
52-year-old male  Initially admitted to the hospital on 02/10/22 with COVID-19 pneumonia.    During the course of admission patient underwent CT chest PE which identified no pulmonary embolism on 02/10/22; CT chest was repeated on 02/19/2020 to to evaluate for pulmonary embolism and identified no acute pulmonary embolism.  Both CT scans identified diffuse pulmonary nodule consolidative ground-glass opacities throughout the bilateral lungs.  Additionally patient underwent ultrasound lower extremities which identified no DVTs bilaterally.  During the course of admission patient was found to have pneumomediastinum; deemed to be likely secondary to positive-pressure positive-pressure ventilation setting of BiPAP and high-flow; discussed with vascular surgery adjusted inspiratory pressure; patient was hemodynamically stable throughout the whole admission; no signs of acute pneumothorax or tamponade, no signs of compression of the IVC.  Serial chest x-ray remains stable.  During the course of admission patient continued to downtrend on O2 requirement; on the day of discharge patient was saturating well on 3 L of O2 via nasal cannula and underwent walk study which he failed.  Was sent home with O2.  During the course of admission patient was found to have elevated blood sugars; hemoglobin A1c: 10; discussed the possible need for insulin with patient which he did not want.  Therefore was discharged home with occasions including glipizide and metformin.  Discussed with him the Augmentin Augmentin results in the setting of chronic steroid use during prolonged admission.  During the course for admission patient reported that he had severe anxiety which was contributing to his hypoxia; therefore was discharged home with a 3 day course of anxiolytics; discussed red flag symptoms with these medications.  Additionally patient was found to be hypertensive therefore patient was started on antihypertensives.  Discussed to follow-up in outpatient setting with PCP.    Admitted 2/10/22 - 2/25/22 Moderna 7/29/21 & 8/26/21
Breakthrough case admission after 4 vaccines Pfizer 1/19/21 Lot# EL3249;  Pfizer 2/9/21 Lot# EM9810;  Pfizer 10/22/21 Lot# EW0172;  Pfizer 5/16/22 Lot# FM9992;
12-11-2007 at approx 09:00am a Dtap/ Hib vaccine (Trihibit) was given by this nurse in error. He is a 4 month old client.  No problems are reported and no noted problems prior to leaving clinic.  However the Hib part of the vaccine is an invalid dose given by this nurse.
Full body chills, fever, shaking/shivering uncontrollably. Full body aches.  Followed by severe migraine the following day, continuing aches.  Lasted the duration of the day, but no fever. By day 3, light headache, symptoms gone by end of day.
Information has been received from a consumer, concerning a female claimed that her daughter who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (LOT# not reported). Subsequently, three months later, the patient experienced chicken pox. At this time of reporting, the patient's outcome was unknown. No further information is available.
The BD syringe was faulty and vaccine came out of the barrel of the syringe.  Unknown how much vaccine was administered to patient.  Patient came back 9/19/22 and received the vaccine again.
Nurse administered vaccine to incorrect patient.  Patient was not in office for COVID-19 vaccination, nurse walked into incorrect room.   Vaccine was given prior to consent from patients mother.  Patient was observed and monitored for 15 minutes and showed no adverse reaction.  Physician discussed vaccination risks and benefits with patient's mother at length.
Terrible taste in mouth; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the right arm on 26Feb2021 at 16:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic sleep disorder (Trazadone) and known allergy to aspartame. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included trazodone (MANUFACTURER UNKNOWN) taken for chronic sleep disorder from an unknown date and unknown if ongoing, colecalciferol (VITAMIN D3), fish oil (OMEGA 3), magnesium (MANUFACTURER UNKNOWN) and naproxen sodium (NAPROSYN); all from unknown dates for unknown indications and unknown if ongoing. On 26Feb2021 at 17:15, the patient experienced terrible taste in mouth. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event terrible taste in mouth was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
shakiness after second Pfizer mRNA COVID-19 injection IM in left deltoid. Vitals taken (WNL) and snacks and juice given before vaccine. Patient felt better and wanted to receive vaccine. Gave vaccine and monitored for 30 minutes in the observation area. Patient felt shaky, so given more snacks and monitored vitals again and sent to urgent care for evaluation. Symptoms resolved in urgent care without intervention. Instructed patient to go eat a good lunch and return if symptoms return or worsen.
soreness on injection point, slight fatigue and nausea, rapid heart rate the same evening.  2nd day, soreness on arm was gone but still slightly fatigued, rapid heart rate and nausea.  3rd day, the same but in the evening, extreme elevated BP (191/100 and kept going up) and heart palps in addition to rapid heart rate, little dizzy and light headed, had stomach aches in addition to the nausea.  All this came suddenly.  Was not doing anything strenuous or ate anything out of the ordinary that day.  Was watching TV when it occurred. Called 911 and EMTs came but couldn't do anything for the elevated BP and went to ER where they monitored me and ran bloodwork and tests to determine if I had a heart attack or issues.  BP was still high 160-145/90s as I was on the machines.  all bloodwork and xray came back with no evidence of heart event (thankfully).  Was discovered I had PVC and will be following up with my doctors for everything next week.   They released me.  Could not deduce it was the related to vaccine but there were no other factors that have changed or added last few days or thus far.
blood clots in both lungs along with lung inflammation; blood clots in both lungs along with lung inflammation; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received the second dose (reported as dose 1) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER2613), via an unspecified route of administration, administered in the right arm on 16Apr2021 at 08:45 AM as single dose for COVID-19 immunisation. Medical history included cholestoral, blood pressure, indigestion. No known allergies. No covid prior vaccination. Concomitant medications included losartan, avoristatin, omezrapole. The patient previously took the first dose (reported as dose 2) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER2613), via an unspecified route of administration, administered in the left arm on 22Mar2021 at 08:45 AM as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02May2021 at 16:00, patient experienced blood clots in both lungs along with lung inflammation. Events caused a call to the emergency responders and a 2-day hospital stay from 02May2021 to 04May2021. Events resulted in Emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Lab data included covid test on 02May2021 was negative (Nasal swab). Lots treatment received for the events. The outcome of events was resolved with sequel on unspecified date.
This spontaneous report was received from a register nurse, refers to an unspecified number of patients, of unknown age and gender. Medical history and concurrent conditions were not reported. The register nurse informed that on an unknown date the patients received improperly stored RECOMBIVAX HB. (Strength, route, dosage, lot# and expiration date were not reported). No adverse were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Developed fevers and left shoulder pain (innoculated L deltoid). Progressed to headache-(evaluated in ER with spinal tap) and then generalized muscle aches, claims of lumps developing over various places on body, tenderness in those palces. Severe fatigue and soreness transient nausea. Difficulty swallowing due to thyroid module/cyst.
About 45 minutes after receiving the vaccine I started feeling a stiffness around the injection site. I used an ice pack for about 40 minutes before I had to leave for work. It felt stiff and sore all day and when I returned from work, at about 7:30PM, when I removed my shirt, I saw that it was red, somewhat swollen & felt hard around the area where I was injected.  At 10PM it's still that way.
Persistent crying and screaming not able to console. Poor oral intake, spell lasted 18 hours.
Pt received COVID vaccine x2; Last one in 3/21. Became COVID positive on 4/18/21. Admitted to the hospital on 4/18/21.