chrisvoncsefalvay/vaers-outcomes huggingface dataset:
National Guard Nurse Note: "1323: approx 10 minutes after Janssen covid 19 vaccine was administered patient c/o feeling 'lightheaded, hot, dizzy, sweaty and shakey'.  Pt vitals were taken b/p 100/60, ox/ra 97%, p 70, r13. Assisted to stretcher in a seated position.  Pt denies headache, vistion changes, or sob.  shis is aox3. Communication is appropriate, no slurred speech.  Pt able to smile w/o facial drooping. Given water to drink and ice pack placed behind her neck.  1338 vitals takend b/p 110/60, ox/ra 96%, p 73, r13.  Pt states she does have a history of anxiety and 'afraid of needles and coming to the clinic today'.  1345: Pt states 'I feel better'. offered pt a snack but declined.  pt denies sob or difficulty breathing.  1400: pt states she feels well enough to leave.  Pt denies dizziness, lightheadedness, shortness of breath, headache or feeling of being hot.  1401 Pt assisted to her vehicle, her friend will be driving.  Pt  adn her friend advised if symptoms return, difficulty breathing or sob, hives, rash or any other unusual symptoms occur to call 911 immedicately."  RA BSN 3/15/21 @ 1412
After receiving COVID vaccine, pt was sitting in a chair coloring and told mom she felt "funny". Mom stated "I thought she was joking" and then pt had syncopal episode from chair and fell back and hit head from child's chair. Writer and EMT immediately evaluated pt.  Initially pt was lethargic, tearful, and frightened by event, states she felt "dizzy" prior to syncope. Pt's VS WNL p episode. Pt appeared pale and stated "I'm scared", mom and staff attending to pt were there for support and mom was reassuring to pt. Pt began to smile and then was able to sit up independently, speak in full sentences, tolerate secretions, and was AAOx4. With mother's permission pt was given water and candy, pt tolerated well. Pt stated "my head hurts" and was provided ice pack by writer. No c-spine tenderness noted, pt denied neck pain. Mom VU of s/s to report, monitoring of pt, and given information for clinic for follow-up. NP aware and agreeable with plan of care. Mom encouraged to use ice pack and children's Tylenol as directed for pain. Pt was monitored for additional time before leaving with mom. Pt was smiling, interacting with staff and mom, laughing at jokes, and taking selfies with mom prior to leaving. Pt's gait steady, respirations even and unlabored
Patient returned to clinic on 6/23/11 and spoke to staff stating that arm hurt after shot and she did not feel well in the afternoon after receiving the shot on 6/21/11.  On 6/22/11 she stayed in bed with chills, arm pain and the arm was warm at the injection site.  Today 6/23/11 arm is swelling, red and hot to touch-used Tylenol and did ice to area.  She also complained of sore throat, funny breathing and not feeling well since receiving the shot.  Patient was seen by NP in our clinic-area of red, swollen in left upper arm is 7cm X14cm and is warm to touch. NP diagnosed cellulitis and gave a RX for Keflex 250mg, one pill 4X/day for 10 days.  Instructions to continue with pain medication and ice for comfort and reviewed s/s to seek emergency care. Patient voiced understanding.  TC on 6/24/11 by NP to patient and patient stated went to ED 6/23/11 after leaving clinic and was diagnosed with bladder infection and dehydration.  Patient stated 6/24/11 doing OK and had multiple infections going on.
Itchy, red rash on entire torso and back. Small red, flat dots that vary in size from a 2 mm to 7mm
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's medical history, drug reactions or allergie were not provided. On 15-OCT-2015, the patient was vaccinated with a dose of ZOSTAVAX (subcutaneously, dose, lot number and expiration date were not provided). Concomitant medications were not provided. On 15-OCT-2015, when the dose was administered, some of the volume of the dose leaked out of the injection site. Pharmacist was not aware of the patient's experiencing any adverse effects. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Vaccine administer closer to Left upper tricep then left deltoid muscle. Patient experiencing redness about 2 inches in diameter. Area is hot, red & swollen. Not itchy.
Pt. received PPV23 on 5/2nd. Pt stops by clinic on 5/4/17 to report reaction at 4:30pm. Right arm swollen and redden from where she received injection, down arm about 2 in. below elbow. Warm to touch, very painful. Pt taking BENADRYL and icing it. 5/5/17 pt better- S/S resolving.
I took both Shringrex shots and I'm still getting them/ suspected vaccination failure; I took both Shringrex shots and I'm still getting them.; This case was reported by a consumer via interactive digital media (Facebook) and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The age group was not reported but selected as an adult as per the vaccine indication. The patient received both the doses of Shingrix shot and still got the shingles. This case was considered as suspected vaccination failure as details regarding the laboratory test confiding shingles and time to onset for shingles were unknown at the time of reporting.
Lymph nodes swollen under R Axilla, small lymph by collarbone, small lump on R breast
pt recv vax 5OCT98 & 7OCT98 pt to ER apneic episode w/color change (bluish) occurred few seconds responded & subsided w/o stimulation; shock like collapse-hypotonic-hyporesponsive episode;
covid test date=Dec2021, covid test result=Positive; covid test date=Dec2021, covid test result=Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date May2021 (Lot number: ew0182) at the age of 41 years as dose 2, single and administered in arm left, administration date Apr2021 (Lot number: ew0158) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "covid test date=Dec2021, covid test result=Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive.  Clinical course: lot number=33025b1, administration date=Jan2022, administration time=10:30 AM, dose number=3, vaccine location=Left arm  No follow-up attempts are possible. No further information is expected.
pt recv vax;devel a local rxn characterized by reddened area w/ rash,area about "hand-sized",affecting inject site & shoulder;
No adverse event; patient that was outside the 12 hours after it was punctured / vial was exposed to room temperature range 21.5 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient that was outside the 12 hours after it was punctured / vial was exposed to room temperature range 21.5 hours) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 050D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient that was outside the 12 hours after it was punctured / vial was exposed to room temperature range 21.5 hours). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient that was outside the 12 hours after it was punctured / vial was exposed to room temperature range 21.5 hours) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient that was outside the 12 hours after it was punctured / vial was exposed to room temperature range 21.5 hours).    Concomitant medications were not reported.  The vaccine that was given to the patient that was outside the 12 hours after it was punctured. They wanted to check if they had to revaccinate the patient or if it is ok for them to keep it. The vial size was 2.5 ml. The vial was initially stored in the refrigerator on 06Dec2022 at 8 AM. The vial was first punctured on 09Dec2022 at 3:45 PM. The administration of vaccine on 10Dec2022 at 1:15 PM. The vial did not undergo any temperature excursions. The vial was exposed to room temperature for 21.5 hours. Treatment medications were not reported.
Numbness; Redness/ red arm; inflamed (swollen) arm; Pain in her arm; Fever; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HYPOAESTHESIA (Numbness), ERYTHEMA (Redness/ red arm), SWELLING (inflamed (swollen) arm) and VACCINATION SITE PAIN (Pain in her arm) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced DIZZINESS (Dizziness), VACCINATION SITE PAIN (Pain in her arm) and PYREXIA (Fever). On 03-May-2021, the patient experienced HYPOAESTHESIA (Numbness), ERYTHEMA (Redness/ red arm) and SWELLING (inflamed (swollen) arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness), HYPOAESTHESIA (Numbness), ERYTHEMA (Redness/ red arm), SWELLING (inflamed (swollen) arm), VACCINATION SITE PAIN (Pain in her arm) and PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included birth control patch Paracetamol had helped with fever but not for the pain.
I started feeling nauseated and weak shortly after the initial shot on 2/28/2021. The next morning I had a 9:00 am appt with the neurolgist Dr. I passed out on the way there while driving but woke up at a stop light (fortunately).  I made it to his office and was awakened by Dr. shaking me because the nurse could not rouse me to come into the examining room.  My BP was 70/40 & I passed out several more times. The doctor called my husband to come get me bc I could not drive.  Dr. wanted me to go to the ER but I was too tired so went home and slept for more than 24 hours.  This drop in BP continued so I called my internist, who referred me to Dr., cardiologist, who sent me for multiple heart test at Hospital.  My test were negative except for high cholesterol.  However, although my low blood pressure is more level now, it goes from 116/50 range in the am to 165/70 by nighttime which it never did prior to the 1st vaccine..  I have a new cardiologist.  There is no definitive treatment for labile bp which I never had before the first vaccine.  I was advised by Dr and his partner not to take the 2nd vaccine but I did without the same immediate reaction.
Itchy red maculopapular rash over entire body (trunk, abdomen, back, arms, legs, genital area).
Patient felt cold/weak, but no rash after the vaccine was administered. Brought to lie down in the observation area. Given water and had BP monitored. Stabilized and went home.
pt recvd vax & 4 hrs later devel pain in the back which radiated around the abdo & down the legs; described this as like paralysis; the pain/paralysis abated & was followed by 5 hrs of weakness; weakness resolved w/o sequelae;
Syncope episode; This case was reported by a nurse via sales rep and described the occurrence of syncope in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included MMR (MMR vaccine) for prophylaxis.   On 4th February 2020, the patient received the 1st dose of Shingrix and MMR vaccine. On 5th February 2020, 1 days after receiving Shingrix and MMR vaccine, the patient experienced syncope (serious criteria GSK medically significant). On an unknown date, the outcome of the syncope was unknown.   It was unknown if the reporter considered the syncope to be related to Shingrix and MMR vaccine.  Additional details were provided as follows: The age at vaccination was not reported, however he could be 52 or 53 years old at a time of vaccination. The patient received Shingrix on left deltoid and MMR vaccine on right deltoid. The patient had a syncope episode at the gym. The patient was seen in the emergency room (ER) and an EKG was done that showed some abnormalities.  The patient was sent home same day and an EKG was repeated in doctor's office the next day. The EKG had same findings. The patient was referred to cardiologist. According to the nurse reporting the incidence, no other side effects were reported. The reporter consented for follow up.      Lab Comments: On the day of syncope, the patient had Electrocardiogram (EKG), had some abnormal findings and was referred to cardiologist
Pt presented to ER complaining of rash in her left deltoid after receiving a diphtheria and Pneumovax vaccination shot. 5 days prior, she developed a fever and worsening of rash. She had also been taking some anti cancer medication since Jan 05 for her breast cancer (unclear as to what it was). Because she has SX consistent with an infection (fever, increase WBC, chills), she was DX with cellulitis. She was treated with ABX and her symptoms resolved. 11/7/06 Received medical records from VAMC which reveal patient admitted 4/12-4/16/06 for rash on right shoulder w/fever & chills x 2 days.  Received tet tox vax 4/8 for finger cut in kitchen accident.  Then received pneumo vax in same region on 4/10.  After 1 day developed rash, pain & fever to 101.   Final DX: cellulitis right arm, hypotension, bipolar affective disorder, breast cancer & anemia. D/C to home on oral antibiotics w/rash almost resolved & pain & fever gone.
Headache & Myalgia Narrative:  Fatigue, headache, muscle aches
Expired vaccine used/ administer expired vaccine to 450 patients, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/ administer expired vaccine to 450 patients, after the manufacture date of expiration.) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/ administer expired vaccine to 450 patients, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/ administer expired vaccine to 450 patients, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  It was unknown if the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received included non-significant information.
itchy; arm hurt and wasn't bad.; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy) and PAIN (arm hurt and wasn't bad.) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced PRURITUS (itchy) and PAIN (arm hurt and wasn't bad.). At the time of the report, PRURITUS (itchy) and PAIN (arm hurt and wasn't bad.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-402924 (Patient Link).
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 06-MAR-2015, the patient was vaccinated with the improperly stored dose of PNEUMOVAX 23 "10 PK 0.5 ml SD-PFS-LLok wTip" lot number K009106 with expiration date of 25-FEB-2016 (dose number, route of administration and anatomical location were not provided), which was stored at -2.77 Celsius Degrees for 384 hours and 0 Celsius Degrees for 40 hours. The type of excursion was refrigerator. No adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
11/8/99 pt rcvd vaccine, 11/10/99 child broke out in hives covering face, back and buttocks with swelling of feet hands and penis.  Nor reports of respiratory problems, alert and oriented.  Has appt. with MD.
Had the shot. Still got the Shingles/ suspected vaccination failure; Had the shot. Still got the Shingles; Still have pain; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but selected as adult as per the vaccine indication. The patient had the shot and still got the shingles, which was cured but still had pain. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation confiding shingles were unknown at the time of reporting.
11/29/07-noticed red area size of a quarter, area was warm,firm,and started to itch. 12/30-red area was larger, itching more.  Benadryl cream and ice packs helped very little.  By 12/1 the red area was about 2 in. by 3 in.  On 12/2 the redness had begun to go away, but still itching some.  Today (12/3) it has continued to lessen, the itching is less, it is no longer warm, and the firm area has just about gone away.
severe nose bleed; This spontaneous case was reported by a pharmacist and describes the occurrence of EPISTAXIS (severe nose bleed) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced EPISTAXIS (severe nose bleed). At the time of the report, EPISTAXIS (severe nose bleed) had 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.   Concomitant medications included unspecified medications but not related to blood thinners. No treatment information was provided.
child that ended up in the hospital for two weeks after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HOSPITALISATION (child that ended up in the hospital for two weeks after the vaccine) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (child that ended up in the hospital for two weeks after the vaccine) (seriousness criterion hospitalization). At the time of the report, HOSPITALISATION (child that ended up in the hospital for two weeks after the vaccine) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment information was not provided.  Company comment- This is a spontaneous case of a child of unknown age and gender, with no reported medical history, who experienced the unexpected serious (hospitalization) event of hospitalisation after a dose of mRNA-1273.222 vaccine was administered. It was reported that child ended up in the hospital for two weeks after vaccine. No further details regarding clinical course, diagnosis, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-710268 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710268:Master case
states 1-2hr p/vax given pt felt tingling & itching in the back of neck, extending down to arm vax given in;also c/o severe nausea lasting until bedtime;no treatment necessary;
Patient received PREVNAR 13 vaccine on 12/14/15. Reported on 2/8/16 that episodes of falling down w/wout consciousness since Jan 2016. Patient believes it was from PREVNAR 13 immunization.
pt recvd vax 7JAN93 & devel hives over entire body next day following immun; called MD but not taken in to see MD hives lasted one day;