chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt c/o feeling tingling and swelling in her tongue and her face after receiving her vaccine. Pt was moved to the Triage room for closer observation. Pt was given oral benadryl and monitored for further symptoms. Pt symptoms continued to progress including itching in her throat and over her face. Pt stated she had reacted to the first dose and was treated with benadryl which successfully managed her symptoms at that time. For this dose, the benadryl did not seem to be effective and d/t progressing symptoms, pt was given IM epinephrine and transported to the ED for further evaluation and treatment.
No adverse effect; Patient received improperly stored vaccine; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition, concomitant medication and drug allergies/reactions was not provided. On 21-NOV-2019, the patient was vaccinated with an improperly stored dose (product storage error) of hepatitis A vaccine, inactivated (VAQTA) (strength, dose, schedule, anatomical location, route of administration was not reported) (lot# S019435 and expiry date: 23-AUG-2020) for prophylaxis. The vaccine underwent a temperature excursion of above 47 degree Fahrenheit/9 degree Celsius (51.8 Fahrenheit) for a duration of 1 hour 25 minutes. There were no previous temperature excursions. There was an involvement of digital data logger. No associated product quality complaint.
Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the Health Clinic that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of (privacy). The CDC website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
I broke out in a rash. Small red bumpy circles all over my body; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 33-year-old male patient received second dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EW0185), via an unspecified route in the left arm on 07Jun2021 at 09:00 (age at vaccination: 33-year-old), as a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included cetirizine hydrochloride (ZYRTEC). Historical vaccine included first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EW0175), via an unspecified route in the left arm on 17May2021 at 09:00 (age at vaccination: 33-year-old), as a single dose for covid-19 immunization. Patient has not taken any other vaccine in four weeks. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No known allergies were reported. On 08Jun2021 at 07:00, after the second dose, patient broke out in a rash: small red bumpy circle all over his body. Adverse event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if patient received any treatment for the adverse event. The clinical outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Information has been received from a physician concerning a 13 month old male pt who on 2/24/00 was vaccinated with MMR. On approximately 3/11/00, the pt developed a rash that started on his face and spread to his legs. On 3/13/00, the pt was seen in the physician's office. It was reported that the pt was afebrile. Addition information has been requested. Follow up provided no additional data.
Patient complaining of syncopal episode. States that she lost consciousness for a few seconds. C/O stomach ache. Transport refused.
TDAP 9/14/10 11AM - 12. Rash noted this AM. States friend saw rash 2-3d ago. Red, raised neck, back, chest.
PAIN STARTED IN L) UPPER ARM IN 24 HRS AFTER INJECTION CONTINUED WITH LEFT UPPER DELTOID PAIN RADIATING INTO HIS LEFT SHOULDER - SXS WORSE WITH ACTIVITY/MOVEMENT - PAIN WITH EXTENSION OF THE SHOULDER + ABDUCTION MAKES WORSE - HE DENIED INJURY TO LEFT SHOULDER @ TIME OF VACCINATION
Had episodes of twitching, characterized by head denoting to Left with twitching of left shoulder and some rolling back of eyes, which occurred numerous times and only seconds in duration each time. Continue to have episodes of head rolling, although decrease in frequency (at 5 days after vaccines). 60 day Follow-up Information 24-OCT-2007: Unsure if symptoms vaccine related. 8/1/07-records received from facility for DOS 6/26-7/6/07-DC summary not available. Presented to ER with abnormal movement of shoulder and head toward left. Temp 100.2.8/15/07-DC summary received for DOS-6/26-6/30/07. DC DX: Viral versus behavioral tick. No evidence of post vaccine seizure at this time. Runny nose for last several days. Temp 100.2 low grade fever in ER.
Left upper arm status post tetanus vaccine 9/13/06 and left shoulder pain 1 week after. Pain 6 out of 10 severity; dull, achy and intermittent aggravated with arm movement. Pain is resolved with rest.
Little reaction to the first dose lot # EW0172. Headache and muscle pain 12 hours after the second dose but only last 1 day.  More headache, fever and severe muscle stiffness near the right arm injection side about 12 hours after the injection and whole body muscle pain on the second day of the injection. Longitudinal Melanonychia on right toe was noticed around second injection lot # EW0178 and confirmed by podiatrist. More melanocytic black spots on the same right toe is noticed 3 days after the third injection lot # FD7218 on 12/18/2021. Otherwise, patient feel normal 0n 12/18/2021.
This case was reported by a healthcare professional (nurse) and described the occurrence of increased liver enzymes in a 61-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date the subject received a dose of BOOSTRIX (unknown details). At an unspecified time after vaccination with BOOSTRIX, the subject experienced increased liver enzymes. No further details were provided. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was related to vaccination with BOOSTRIX. The subject, who was a physician, "complained to the nurse that he thinks it was BOOSTRIX that increased his liver enzymes."
8/5/02 pt experienced racing heart for short period of time (few minutes). This reaction being a result of the immunization vaccine is questioned by the physician.
had your vaccine on 04Jan, tested positive for Omnicron on the 5th; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program (005570). A male patient received bnt162b2 (BNT162B2), administration date 04Jan2022 (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 reporter had a patient that received the vaccine on 04Jan2022 and tested positive for Omnicron on the 5th  (05Jan2022) who was trying to leave on a cruise on the 29Jan2022. The He must be vaccinated by today or tomorrow to meet the requirements of the cruise ship of being vaccinated two weeks before boarding. The reporter inquired how early can he be administered the second vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient experienced redness and minor swelling beginning 2 to 3 days post injection at injection site. Presented to pharmacy on 5/28/19 with more generalized redness on his left arm
Tested positive 01/31/2022, I was released back to work 02/05/2022. My throat started to get scratchy on 01/30/2022. I found it difficult to breath as I got myself worked up some because my husband had passed away from COVID-19. I started feeling different and knew I needed to take a test. It all stayed in my throat it did not move from there. My main symptoms were a croupy cough and a low-grade temperature. It was very scary even though I had mild symptoms.  I spoke to my doctor and she recommended over the counter medications and warm beverages to help sooth my throat. Currently I am very sensitive to chemical fumes and my sense of smell has changed and my sense of taste has been diminished since I had the COVID-19 infection.
This case was reported by a healthcare professional and described the occurrence of injection site abscess in a 24-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 22 August 2014, the subject received a dose of BOOSTRIX (route unknown, right arm). On 24 August 2014, 2 days after vaccination with BOOSTRIX, the subject experienced bump at injection site which growed and turned into injection site abscess. This was considered as an allergic reaction. This case was assessed as medically serious by GSK. The subject was treated with Antibiotic. On 5 September 2014, the abscess ruptured and it bleed. At the time of reporting, allergic reaction was unresolved. The healthcare professional considered the allergic reaction was probably related to vaccination with BOOSTRIX.
Patient came in to observation area after receiving the covid vaccination, while she was admitted to the waiting area she started to sit on the floor. Nurse approached her and guided patient to the floor. Patient began to lose consciousness while nurse was guiding her head to the floor.  Patient was placed on one side for seizure precaution, vitals were initiated, and EMS was activated. Patient was monitored continuously, legs were elevated, and ice packs were applied to the nape of the neck and the patient extremities. Patient was assisted into a seated position. Pt was provided PO fluids and graham crackers. Patient was ambulated from the floor to the chair by nurses. EMS arrived on site, assessed the patient, and patient was transported to the hospital by the EMS.
Generalized pink discoloration at the injection; Lump near the injection site; COVID Arm; Red patch on the injection upper arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Generalized pink discoloration at the injection), VACCINATION SITE MASS (Lump near the injection site), RASH ERYTHEMATOUS (Red patch on the injection upper arm) and VACCINATION SITE REACTION (COVID Arm) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     NO Medical History Information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced RASH ERYTHEMATOUS (Red patch on the injection upper arm). On 31-Jan-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Generalized pink discoloration at the injection), VACCINATION SITE MASS (Lump near the injection site) and VACCINATION SITE REACTION (COVID Arm). At the time of the report, VACCINATION SITE DISCOLOURATION (Generalized pink discoloration at the injection), VACCINATION SITE MASS (Lump near the injection site), RASH ERYTHEMATOUS (Red patch on the injection upper arm) and VACCINATION SITE REACTION (COVID Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     No relevant concomitant medications were reported.  Treatment details included Ice to treat the delayed injection site reaction.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021:
Pericarditis and blood clots in arms. Symptoms started first week of august 2021
This spontaneous report was received from a physician refers to a 17 year old female patient. The patient supposed to receive a second dose of M-M-R II, a second dose of (Oka/Merck) VARIVAX and an unspecified meningococcal vaccine on 27-FEB-2015. The patient received M-M-R II, and unspecified meningococcal vaccines but she was inadvertently administered ZOSTAVAX instead of (Oka/Merck) VARIVAX second dose, lot # K020801, expiration date: 31-JAN-2016, (dose and route of administration were not reported). No adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced a mild breakthrough of chickenpox without any complication for a duration of 4 days.
T100.3 to 104 & dec 99.4 x 3-4 days;severe redness of face from elbow to hands, from chin to chest-elbow & neck subsided p/2 days;face stayed fine red for 5-6 days;BP elevated;pt felt scalding hot;puffy look;
Father of the child states that he received vaxs on 01/24/2000. Child started breaking out with rash a day or so prior to developing high fever (102.6) and becoming incoherent for about 10 minutes. ER staff wanted to see child because of history of febrile seizures and to rule out encephalitis. On 02/28/2000 child has improved.
nerve damage; This spontaneous report was received from a lawyer, regarding a case in litigation and refers to a female patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. In on around October 2018, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, site of administration, lot #, and expiry date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, reported as shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered nerve damage. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the suspect vaccine, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of nerve damage was considered to be not recovered/not resolved. The reporter regarded the event as related to zoster vaccine live (ZOSTAVAX).  The event of nerve damage was considered by the reporter to be disabling.
Area size of fist/orange-red, swollen, tender. Resolving - but now bruising - no signs of infection. Resolving on its own
hives on multiple areas of her body which worsened and began to blister and ooze; hives on multiple areas of her body which worsened and began to blister and ooze; rash on her neck; soreness on her left/injection arm; This is a spontaneous report received from a contactable nurse. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 14Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  On 16Apr2021, she developed a rash on her neck and had expected soreness on her left/injection arm. She stated the next morning (17Apr2021) she had hives on multiple areas of her body which worsened and began to blister and ooze. She reported they were similar to a shingles rash. She started a methylprednisolone (MEDROL) dose pack on 19Apr2021 and stated the rash continued but had not worsened. Outcome of neck rash was not resolved. Outcome of other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Anxious; Pain in ovaries; Pain on waist that extended to back; Pain on leg; Stomach full of gases; Stomach swollen; Her feet cold and sweaty; Feet cold and sweaty; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Pain on waist that extended to back), PAIN IN EXTREMITY (Pain on leg), FLATULENCE (Stomach full of gases), ABDOMINAL DISTENSION (Stomach swollen) and PERIPHERAL COLDNESS (Her feet cold and sweaty) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced BACK PAIN (Pain on waist that extended to back), PAIN IN EXTREMITY (Pain on leg), FLATULENCE (Stomach full of gases), ABDOMINAL DISTENSION (Stomach swollen), PERIPHERAL COLDNESS (Her feet cold and sweaty) and HYPERHIDROSIS (Feet cold and sweaty). On an unknown date, the patient experienced ANXIETY (Anxious) and ADNEXA UTERI PAIN (Pain in ovaries). At the time of the report, BACK PAIN (Pain on waist that extended to back), PAIN IN EXTREMITY (Pain on leg), FLATULENCE (Stomach full of gases), ABDOMINAL DISTENSION (Stomach swollen), PERIPHERAL COLDNESS (Her feet cold and sweaty), HYPERHIDROSIS (Feet cold and sweaty), ANXIETY (Anxious) and ADNEXA UTERI PAIN (Pain in ovaries) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.     Reporter did not allow further contact
Died at home; Gasping for air/difficulty breathing; Soreness; A spontaneous report was received from a physician concerning a 45 years-old, female patient who experienced soreness/MedDRA PT: pain, gasping for air/difficulty breathing/MedDRA PT: dyspnoea and subsequently died/MedDRA PT: death.  The patient's medical history included blood pressure (disorder not specified), thyroid disorder, depression and anxiety. Concomitant product use included blood pressure medication, thyroid medication and possibly depression and anxiety medication.  On 28 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot #007M20A) (route of administration and injection site not provided) for prophylaxis of COVID-19 infection.  On 28 Jan 2021, following the vaccination, the patient was fine but had experienced some soreness.  Per patient's coworker, the patient did not take any medication as it made the patient sick. The physician was not aware of any complaints from the vaccine.  On 13 Feb 2021 at 3:31am, the patient called 911. Per the 911 call, the patient was gasping for air on the call and having difficulty breathing. The patient subsequently died on 13 Feb 2021 at home. The physician inquired whether Moderna gets involved with the autopsy and logistics of the death of patients and wanted to know the time frame for reporting a death of a patient who received the vaccine. The physician did not know who administered the patient's vaccine.  Action taken with mRNA-1273 in response to the events was not applicable as the patient deceased.  The event died was fatal. The outcome for the events soreness and gasping for air/difficulty breathing was unknown.  The patient died on 13 Feb 2021. The cause of death was not provided. Plans for an autopsy were not provided.; Reporter's Comments: Very limited information regarding the event of dyspnea and death has been provided at this time. Further information has been requested. Patient's medical history of blood pressure is considered a risk factor. Based on the current available information and temporal association between the use of the product and the onset of the pain, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Died at home
Sudden onset of rash around injection site 8 days after vaccination. Skin was red and very itchy. Started to go away on day 3.  Almost gone by day 4.
Sore injection site Red rash (approx 4 inches) Ear pain Nasal irritation
Flushing, itch, tachycardia. Resolved within 1 hr post administration of IM Benedryl
Due date July 18,2021 but delivered later. Tightness in chest, used asthma pumped for 4 weeks every four hours.
Aprox 2mins after vaccines were administered child began to visibly shake/twitch a little. She admitted to be a little nervous but felt fine. Denied any dizziness, nausea, or feeling light headed. Ate breakfast this morning. Oriented and alert but can feel her body twitching more strongly after after aprox another 2mins. Client continued to sit upright and talk with Grandmother and staff. Twitching decreased significantly but still occurring. Client continues to be alert and oriented allowed to walk around in office and did so without issue. Discharged from office at 12:03pm with very mild occasional twitch. Advised to f/u with ER if symptoms returned.
extremely pale, fever, throwing up, diarrhea continued throwing up until 4:00 AM, still has a fever at this time which is 02/02/2010 10:30 AM
Received vaccination on 05/20/2022. Tested positive for COVID-19 on 06/20/2022. Breakthrough case. Home test.
Chills; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (patient have had shingles and bit the bullet).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced chills (Verbatim: Chills). The outcome of the chills was recovered/resolved.   It was not reported if the reporter considered the chills to be related to Shingles vaccine.     It was not reported if the company considered the chills to be related to Shingles vaccine.   Additional Information: GSK receipt date: 28-Feb-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had shingles, bit the bullet, and got the shots. The patient stated that one night of chills was not anywhere near as bad as the shingles. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
Patient was administered Pfizer vaccine based on the self-attestation, provided by the LTC home where they reside.  The home administrator provided the signed vaccine administration questionnaire and the self-attestation. Later, upon entering the information into our system and performing the additional verification (something we do as part of our data tracking), the pharmacist discovered that the patient had completed her COVID19 vaccine series in March, however, with Moderna, not Pfizer. Boarding care/patient was notified immediately, patient has been monitored since and has no complaints of adverse reactions.
Patient was given a dose of MMRV instead of MMR.  It had been over a week once it was noticed that a wrong dose had been given. Was discovered while doing inventory. Patient has now received two doses of Varicella in one visit on 10/10/23. There was no reaction with the patient that was discovered.