chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Disorientation; Body aches; Brain fog; Sweats; Joint pain (especially in knees and lower back); Mild headache; Nausea; Chills; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old, non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route on 21Apr2021 at 10:15 hours in the left arm (at an age of 19-year-old) as single dose for COVID-19 immunisation. Prior to vaccination, the patient was diagnosed with COVID-19. The medical history of the patient included dairy allergy. The patient received ethinylestradiol, norethisterone acetate (JUNEL FE 24) within 2 weeks of COVID-19 vaccine for birth control. The patient did not receive any other vaccination within 4 weeks of vaccination. Previously, the patient also received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route on 31Mar2021 at 10:15 hours in the left arm as single dose for COVID-19 immunisation. On 21Apr2021, 9 hours post vaccination, at 21:15 hours, the patient had chills, sweats, body aches and joint pain (especially in knees and lower back), brain fog or disorientation (possibly due to headache), mild headache and nausea and were still ongoing. It was 24 hours post second vaccination at the time of this report. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events of chills, sweats, body aches and joint pain (especially in knees and lower back), brain fog or disorientation, mild headache and nausea were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
mom called MD office 3 days p/vax;pt said hands & fingers were tingling & numb;having diff lifting things;on exam neuro assessment nl x/forearm, radial side had a rectangular area of loss of sensation 2x6 cm;
He states that the injection site was painful but there was no redness or swelling at the site. He states that the pain went up to his right shoulder and up to the base of his neck. He states that he also had some joint discomfort at the left elbow. The right arm was warm/red and swollen, is now subsiding. No fever or chills.
patient reports having bodyaches affecting both legs and arms.  symptoms still persistent approximately 1 week after vaccination
I received the second dose of the vaccine around 9:30am on Tuesday March 30, 2021. I felt fine until around 8:30pm that same evening. I had body aches and I was exhausted. My head also started to hurt. I experienced body aches/head ache as well as chills all night. I woke up Wednesday March 31, 2021 with body aches and chills and a fever of about 100 degrees. I took one pill of Tylenol and the fever went away and I did not experience another fever. The symptoms got better throughout the day but I was quite exhausted and did not fully recover until I woke up the next day Thursday April 1, 2021.
Radiation; Chemotherapy; This case was reported by a pharmacist via call center representative and described the occurrence of radiation therapy in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced radiation therapy and chemotherapy. On an unknown date, the outcome of the radiation therapy and chemotherapy were unknown.   It was unknown if the reporter considered the radiation therapy and chemotherapy to be related to Shingrix.   Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that a patient started radiation and chemotherapy after receiving the 1st dose of Shingrix. No additional information was given. The pharmacist consented to follow up.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2022 at 12:30 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. 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.
Injection site swollen, reddness, itching. Pt. was seen and dx with Rash and was given steroid injection, and prescribed Prednisone
This case was reported by a pharmacist via call center representative and described the occurrence of feels awful in a 56-year-old male patient who received Shingrix (batch number P3777, expiry date 30th January 2020) for prophylaxis. Co-suspect products included Shingrix for prophylaxis. On 14th February 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced feels awful, immune system disorder and incomplete course of vaccination. On an unknown date, the outcome of the feels awful and immune system disorder were recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the feels awful and immune system disorder to be related to Shingrix. Additional details were provided as follows: The healthcare professional reported that the patient experienced a horrible reaction after their first dose of Shingrix. All he know that the patient felt awful and it messed with their immune system. The healthcare professional believed the patient was recovered at that point. The patient had not received 2nd dose at the time of reporting, which led to incomplete course of vaccination. The healthcare professional did not know if the patient would receive the 2nd dose. The healthcare professional provided lot number (A5X5B) and expiration date (7th March 2021), if the patient would receive the 2nd dose this would be what he receives.
Patient experienced facial flushing, tachycardia and hypertension.  Flushing occurred from the base of the neck and covered the neck, face, side of face, eyebrows, and forehead.  There was no rash, swelling or redness on any other part of the body or injection sight.  Heart rate was 122 BPM at onset and decreased to 77 BPM during the course of observation.  BP was recorded at 197/124, 194/120.   Patient was observed for approximately 1 hour.  Patients physician was contacted during the observation period.  Physician advised against the use of diphenhydramine and recommended an additional dose of the patients Metoprolol.
Patient presented to the ED and was subsequently hospitalized for COVID-19 within 6  weeks of receiving COVID vaccination.
Vaccination failure; Strain A of the flu/Influenza test was positive for influenza virus A; Diagnosed with the strain A of the flu; This is a spontaneous case, reported by other health professional (nurse) on 21-Feb-2019, concerning a 05-year-old, female, child patient.  The patient did not have any medical history and did not take any medications at the time of vaccination.  On 29-Sep-2018, the patient was administered Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent, cell-culture-derived, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252664 and expiry date: 30-Jun-2019] for influenza prophylaxis.  On 20-Feb-2019, 4 months and 22 days after vaccination, the patient underwent influenza test and was diagnosed with strain (reported as string) A of the flu (influenza A virus test positive) (considered as vaccination failure). The reporter was unsure of any treatment medications for the event.   The outcome of the event was recovered on an unspecified date.  The reporter assessed this case as non-serious.  Non-significant follow up received from the reporter on 29-Apr-2019: The Med-info number (SEQ19-01197) was added in the additional information tab. It was reported that attempts were made to reach the reporter on 28-Mar-2019 and 29-Mar-2019 but the reporter had not reached back to them to date. No new information available. Hence, no changes were made in narrative.  Follow-up received from the other health professional on 28-May-2019: The start date of the lab test (influenza A virus test) was added as 20-Feb-2019 in the patient tab. The start dates of the events (influenza and influenza A virus test positive) were added as 20-Feb-2019 in the event tab. The new event (vaccination failure) was added in event tab. The outcome of the event influenza' was changed from not reported' to recovered' in the event tab. Eventually, as determined causality' of the event (influenza) was changed from unassessable to related' in event assessment tab. It was stated that, the reporter was unsure of any treatment medications for the event. The narrative and case comment were amended accordingly.  Non-significant follow-up received on 11-Jul-2019: It was reported that attempt was made to reach the reporter on 10-Jun-2019, 20-Jun-2019 and 10-Jul-2019 but no information was obtained. No changes were made in the narrative.; Reporter's Comments: A 5-year-old, female, child underwent influenza test and was diagnosed with strain A of the flu (influenza A virus test positive) (considered as vaccination failure), 4 months 22 days after Flucelvax QIV vaccination (coded to influenza and vaccination failure). Considering the fact that vaccine needs minimum 2-3 weeks to provide immune protection against influenza, vaccination failure and causal role of suspect vaccine for the event influenza cannot be ruled out and were assessed as related to suspect vaccine. Further assessment will be done upon receipt of new information. The company assessed the case as serious (medically significant).
Felt like something in her chest like a bomb after getting 3rd dose; Had a cold; felt like a flu; she had sever reaction after receiving 3rd dose; Could lift her head up off the pillow this time; Patient is still experiencing little fatigue; little bit of a headache that is more toward sinus; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Felt like something in her chest like a bomb after getting 3rd dose), NASOPHARYNGITIS (Had a cold), INFLUENZA (felt like a flu), SINUS HEADACHE (little bit of a headache that is more toward sinus) and VACCINATION COMPLICATION (she had sever reaction after receiving 3rd dose) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Non-smoker and Vaccination adverse reaction. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMINS NOS for an unknown indication.    On 07-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Sep-2021, the patient experienced SINUS HEADACHE (little bit of a headache that is more toward sinus). On an unknown date, the patient experienced CHEST DISCOMFORT (Felt like something in her chest like a bomb after getting 3rd dose), NASOPHARYNGITIS (Had a cold), INFLUENZA (felt like a flu), VACCINATION COMPLICATION (she had sever reaction after receiving 3rd dose), HEAD DISCOMFORT (Could lift her head up off the pillow this time) and FATIGUE (Patient is still experiencing little fatigue). The patient was treated with AZITHROMYCIN (Z-PAK) on 19-Sep-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, CHEST DISCOMFORT (Felt like something in her chest like a bomb after getting 3rd dose) and HEAD DISCOMFORT (Could lift her head up off the pillow this time) outcome was unknown and NASOPHARYNGITIS (Had a cold), INFLUENZA (felt like a flu), SINUS HEADACHE (little bit of a headache that is more toward sinus), VACCINATION COMPLICATION (she had sever reaction after receiving 3rd dose) and FATIGUE (Patient is still experiencing little fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative and. On 15-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Body temperature: abnormal (abnormal) Had temperature.         Patient went on PCR COVID-19 test on 28-Sep-2021.   This case was linked to MOD-2021-334391, MOD-2021-335705 (Patient Link).
Nausea, headache day after injection. 1/2 baseball size swelling under right arm 2 days after injection
45 TOTAL VIALS INVOLVED IN TEMPERATURE EXCURSION; ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. 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: 1855194 expiry: 09-APR-2021) dose was not reported, administered on 16-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-NOV-2021, the patient experienced administration of expired vaccine. On an unspecified date, the patient experienced 45 total vials involved in temperature excursion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine and 45 total vials involved in temperature excursion was not reported. This report was non-serious. This case, from the same reporter is linked to 20211143086 and 20211139494.
Pt. developed emesis, vomiting blood afternoon after covid vaccine. She died within a few minutes. Resuscitation not attempted due to DNR status. Had recovered from covid months before.
Pt. states that after receiving the 1st of Phizer 08/12/2021, started experiencing symptoms 15mins of face numbness, panic attacks (night), muscle spasms, pins and needle feeling throughout body, chills through extremities, sharp pain moving through arm, chest pressure, wheezing, dizziness, and nausea. Tested Covid-Negative twice. Currently breastfeeding 2yr old child, Urgent-Care visit 08/29/2021 prescribed Valium. Cat-Scan, Blood Work
Dizziness, Headache, Myalgia, Fever, fatigue Narrative: fever for the last 2 days achy and fatigue. Fever to 102.1 on Sat morning 1/9 and 100.4 on Sunday morning 1/10. 1/8 onset of symptoms was about  6pm with Headaches and dizziness. Fever was in am on 1/9/21 @ 8:03 am Resolved as of 1/11.
Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: pt started having itching/rash all over body 10mins after shot
Pt reported history of anxiety with needles prior to vaccine administration. Pt reported nausea, dizziness and headache about 5 minutes after receiving the vaccine. He was visibly sweating on exam. Ice packs were given (forehead/neck); initial BP was 152/92mmHg. pt was observed for an additional 10 minutes after moving into his air conditioned car; his repeat BP was 124/86mmHg.  Pt reported feeling better and cooler prior to being released.
Child received KINRIX IM, Left Deltoid, on 5/30/18 (5th Dtap, 5th Polio dose). (without noted incident). 05/31/18 am, mom reported child had fever to 101.2, redness, swelling and discomfort to arm. Today, 6/1/18; symptoms continued with increased redness, swelling to left arm. Per MD note "approx. 4 by 2.5cm raised, eryth edematous region left post arm at vaccination site.  Irregular border and irreg. coloration (vesicular) within area.
Fainted; Concussion; Dizziness / Light-headed; Vertigo; Loss of  taste; Lost sense of smell; Soreness in the arm; This spontaneous case was reported by a physician assistant and describes the occurrence of SYNCOPE (Fainted) and CONCUSSION (Concussion) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid activity decreased and Allergy (Undefined allergies). Concomitant products included CLARITHROMYCIN (CLARITRON) for Allergy, THYROID for Thyroid activity decreased.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced PAIN IN EXTREMITY (Soreness in the arm). On 17-Apr-2021, the patient experienced VERTIGO CNS ORIGIN (Vertigo), AGEUSIA (Loss of  taste) and ANOSMIA (Lost sense of smell). On 18-Apr-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant), CONCUSSION (Concussion) (seriousness criterion medically significant) and DIZZINESS (Dizziness / Light-headed). On 18-Apr-2021, SYNCOPE (Fainted) had resolved. At the time of the report, CONCUSSION (Concussion), AGEUSIA (Loss of  taste) and ANOSMIA (Lost sense of smell) outcome was unknown and DIZZINESS (Dizziness / Light-headed), PAIN IN EXTREMITY (Soreness in the arm) and VERTIGO CNS ORIGIN (Vertigo) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received her first dose of the Moderna COVID-19 vaccine on Friday (16-Apr-2021) morning in the left arm and had very minimal symptoms, just soreness in the arm.   On Saturday evening, she experienced dizziness, was light-headed and fainted  She had a concussion because she fell on the floor in her home.   She is currently experiencing vertigo and still feels dizzy and light-headed, probably as a result of the concussion.   She lost her sense of taste and smell more than likely as a consequence of the concussion. Her arm is still a little bit sore.  Treatment for the events: Tylenol (acetaminophen) and Benadryl (diphenhydramine) to sleep at night.  company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Redness, warmth at site, itching. BENADRYL, ice to site, Hydrocortisone cream.
SARS-CoV-2 N gene Resp Ql NAA+probe~SARS-COV-2 (COVID-19) CLINIC COLLECT KIT OR EXTERNAL KIT performed on 7/13/2021 at 11:29. Test came back positive. Based on case investigation documentation, client is asymptomatic and reports no chronic health conditions.
headaches after my 2nd dose which would not respond to Tylenol or ibuprofen; Heart pain and ocular migraine; Heart pain; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (Heart pain) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Latex allergy and Drug allergy (Allergy to Bactrim (Sulfamethoxazole And Trimethoprim)).   On 18-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ANGINA PECTORIS (Heart pain) (seriousness criterion medically significant). On 25-May-2021, the patient experienced MIGRAINE (Heart pain and ocular migraine). On an unknown date, the patient experienced HEADACHE (headaches after my 2nd dose which would not respond to Tylenol or ibuprofen). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency and IBUPROFEN for Headache, at an unspecified dose and frequency. On 31-May-2021, ANGINA PECTORIS (Heart pain) had resolved. At the time of the report, MIGRAINE (Heart pain and ocular migraine) was resolving and HEADACHE (headaches after my 2nd dose which would not respond to Tylenol or ibuprofen) outcome was unknown.            No concomitant medicines were reported. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  On 04-Nov-2021, the vial was placed in the refrigerator. The vial did not undergo any temperature excursion and the patient had no adverse event.  No treatment information was provided.   This case was linked to MOD-2022-491837 (Patient Link).
Patient stated " bad taste in mouth" denied trouble swallowing several times. All resolved after 2-3 minutes
Experienced typical atrial flutter during colonoscopy on 07/15/2021. It was verified on 08/10/2021 at hospital.
having swelling at the injection site to her arm 10 days after the injection of the vaccine; This is a spontaneous report from a contactable physician. A 7-decade-old (reported as in her 60's) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported.  The reporter asked if it was normal for a patient to have delayed swelling at injection site on the arm after getting the vaccine. Reporter mentioned that she is a physician whose patient started having swelling at the injection site to her arm 10 days after the injection of the vaccine. Reporter asked should the patient receive the second dose of the vaccine. Outcome of the event was unknown.  Information on the lot/batch number has been requested.