chrisvoncsefalvay/vaers-outcomes huggingface dataset:
With patient sitting in chair, Boostrix and Gardasil were administered simultaneously by the nurses.  When Menactra was then administered, pt. had following symptoms for 1 minute - eyes rolled back, color became ashen, arms jerked twice, pt. was non-responsive and slumped in chair.  Pt. then responded to verbal questions.  She shook her head, "Yes", when asked if she was dizzy and nauseated.  Pt followed verbal commands and was assisted to exam table and laid down.  B/P - 94/64. Pulse - 68, regular. Cool compress applied to forehead.  Pt. stated she felt better and drank approx. 3 ounces of water. Pt. rested on exam table for 20 minutes.  At 11:50am - B/P - 96/52. Pulse - 64.  Pt. was assisted from table and was able to walk without assistance.  No further complaints voiced.  Pt. left office, accompanied by mother.
Swollen lymph nodes in right arm pit and breast (vaccine was given in right arm), followed by sore joints, muscle cramps, and fever. These symptoms last from 3/25/15-3/31/15. On the evening of 3/31/15, PT developed a rash on the chest, arms (both), back, and face. The rash was mostly gone by the 4th, but was still itchy on the 6th. Missed 2 days of work.
Patient was given an extra Hepatitis A vaccination, he should have received a HPV vaccination. Patient did not have any adverse reaction. Provider and patient's parent were contacted in regard to the extra vaccination that was given.
dizziness, congestion, cough, heart rate elevated, fatigue, injection site pain, chest heaviness negative Covid test
HPI AND HOSPITAL COURSE   History of Present Illness:  As per admission H&P, "Pt is a 75 y.o. female who was brought in by her daughter due to development of confusion. She was diagnosed with UTI and left distal radius fracture on 7/9 and given oral ABX from the ER. She stopped taking the ABX on 7/13. Confusion started a few days ago and has worsened. She still has UTI. K 2.6, CO2 19. Procalcitonin 0.42. She has been admitted."   Hospital Course: Pt, is a 75 y.o. female who presented with confusion.  He was managed for the following:   * Acute metabolic encephalopathy  Acute metabolic encephalopathy - improved. Due to UTI, she improved with treatment, stable at baseline.     Acute UTI - E.coli on urine culture.  Changed to macrobid based on sensitivity, complete 5 day course.     Paroxysmal A fib - continue eliquis, betapace.  Seen by cardiology, no change.     COVID-19 infection - on room air, no hypoxia.  No indication for steroids.     Diarrhea - resolved. C diff negative.     CAD - continue plavix.    Left wrist fracture - increased pain, and c/o left thumb feeling numb.  Obtained repeat xrays and evaluated by ortho, she was cleared for discharge home with outpatient follow-up.             Physical Exam on the Date of Discharge: Blood pressure (!) 181/51, pulse 58, temperature 98.6 °F (37 °C), temperature source Oral, resp. rate 16, height 5' 4" (162.6 cm), weight 54.4 kg (120 lb), SpO2 97 %. General - NAD, appears stated age  HEENT - EOMI, PER, MMM, oropharynx clear Chest - lungs clear bilaterally, no w/r/r, normal effort Heart - RRR, NS1S2, no m/r/g Abdomen - Soft, non-tender, non-distended, +BS,  Extremities - left wrist in brace Psych - AAOx3, affect appropriate Skin - no rash, dry   Discharge Condition: imroved   Disposition: home
No adverse event. I was unaware at the time of giving the immunization that our refrigerator had at some point reached freezing over night.
Having tons of hair loss; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jun-2021 and was forwarded to Moderna on 14-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Having tons of hair loss) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, the patient experienced ALOPECIA (Having tons of hair loss). At the time of the report, ALOPECIA (Having tons of hair loss) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment was received.  Reporter reported hair loss is continuing, states she looks like "a balding man".   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: FU received on 05-08-2021 with Event outcome continuing and No new information.
Vaccine was initially stored in the refrigerator-05-Jan-2023 and administered on 07-Feb-2023 at 11:14; No adverse reaction; administered doses of the bivalent booster which were beyond the 30 day BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered doses of the bivalent booster which were beyond the 30 day BUD), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator-05-Jan-2023 and administered on 07-Feb-2023 at 11:14) and NO ADVERSE EVENT (No adverse reaction) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Feb-2023 at 11:16 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 07-Feb-2023 at 11:16 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered doses of the bivalent booster which were beyond the 30 day BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator-05-Jan-2023 and administered on 07-Feb-2023 at 11:14) and NO ADVERSE EVENT (No adverse reaction). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered doses of the bivalent booster which were beyond the 30 day BUD), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator-05-Jan-2023 and administered on 07-Feb-2023 at 11:14) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (administered doses of the bivalent booster which were beyond the 30 day BUD) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator-05-Jan-2023 and administered on 07-Feb-2023 at 11:14).    No concomitant medications were reported.  Pharmacist reported that they inadvertently administered 4 doses of the bivalent booster which were beyond the 30-day BUD. 2 doses were administered on 06-Feb-2023 and 2 doses on 07-Feb-2023.  It was reported the patient had ever been diagnosed with/ tested positive for COVID-19 was unknown.  It was unknown if the patient had any acute illness at the time of vaccination.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-709192, US-MODERNATX, INC.-MOD-2023-710238, US-MODERNATX, INC.-MOD-2023-710239 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-709192:Patient - Female US-MODERNATX, INC.-MOD-2023-710238:Patient - Male US-MODERNATX, INC.-MOD-2023-710239:Patient
hives all over entire body, lip swelling, in 3-4 hours after administration.
Increased clotting during period. Huge clots of tissue and some blood. Large neon yellow tissue clot came out during ovulation with neon yellow tinged discharge.
Information has been received from a physician concerning a female patient who was vaccinated with her first dose of GARDASIL (Lot # not reported).  After she received the first vaccine her arm was tingling and she had a pins and needles feeling in the arm.  The patient sought unspecified medical attention.  Subsequently, the patient recovered and she received the second dose of GARDASIL on 10-NOV-2008.  At the time of the report, on 11-NOV-2008, the office was unaware if this experience happened again.  Additional information has been requested.
Painful left thigh. Slight swelling. Tx - cold compresses and ibuprofen.
The patient has weeping sores on his arms where the Dexcom G7 was attached.  But he was wearing them at the time of vaccination. He was in a hot tub as well and thought that might contribute  to the reaction. Patient is still treating the sores on the back of each arm with topical steroids,  Vitamin E oil, and fexofenadine for itching.
MD gives all the injections; uses legs or infants uses buttock or older children; erythematoes, hard spot on lt buttocks-much worse than ususal;
Pt denied pregnancy at time of vaccine on 6/19/08 and 6/23/08.  Came to clinic 7/1/08 and had positive pregnancy test.   Report made to Merck Pregnancy Registry.  Patient also reported to OB MD.
This was Moderna Booster . Had primary 2 dose shots of PFIZER in April 2021. After 2nd Pfizer, had shoulder, elbow and hand jont pain / discomfort. was feeling a little better , till booster ... AFTER booster, shoulder, wrist, hand joint pain flared up again. Still have pain especially in the A.M. upon waking. Feels better as day goes on , exercising and massaging the locations plus drinking Tea/Coffee with Tumeric, Cinnamon, Gnger, Blk Pepper and Cayenne for inflamation.
RARE UNKNOWN HEART CONDITION; OFF LABEL USE IN UNAPPROVED AGE GROUP; This spontaneous report received from a consumer concerned a 17 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. The patient was 17 year old and received vaccine which was (off label use in unapproved age group). The drug was associated with Off label use. No concomitant medications were reported. On an unspecified date, the patient experienced rare unknown heart condition. On an unspecified date, the patient died from rare unknown heart condition. It was unknown whether the autopsy was performed. The reporter stated that, "I have close friends that work for J and J and their 17 year old son passed away from an rare unknown heart condition." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use in unapproved age group was not reported. This report was serious (Death). This case, from the same reporter is linked to 20220745936 and 20220745839.; Sender's Comments: V0: 20220746027- covid-19 vaccine ad26.cov2.s- rare unknown heart condition. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: RARE UNKNOWN HEART CONDITION
Redness and swelling of the face, rash on chest arms, and face. Tingling and numbness in face. Subsided with taking Claritin and Benadryl over the counter
Information has been received from a licensed practical nurse concerning a 34 year old pregnant female with seasonal allergy and thyroid disorder but not on supplements, who on 30-JUL-2008, was vaccinated with the first dose of 0.5 ml MMR II (rHA) (lot # 657244/0527U) in the left upper arm. Concomitant therapy also given on 30-JUL-2008 included TWINRIX, ENGERIX-B. The patient was vaccinated with the second dose of MMR II (rHA) (lot # 659782/0842X) on 03-SEP-2008, in the left upper arm. Concomitant therapy included FLONASE and ENGERIX-B also given on 03-SEP-2008. The nurse states that the patient had been given the VIS vaccine information sheet before getting vaccinated. On 02-OCT-2008, the patient called the doctor's office yesterday stating she had taken a home pregnancy urine test which was positive. The patient's first day of her last menstrual period was 15-AUG-2008. Estimated date of delivery was 22-MAY-2009. No product quality complaint involved. Follow-up information was received. On 02-NOV-2008, the patient experienced spotting. She was seen by the OB/GYN physician. A pelvic ultrasound was performed which was reported as normal. Additional information has been requested.
Patient developed altered mental status and 4+ pitting edema on 9/11/21.  Her condition deteriorated over the next 2 days, and she was hospitalized on 9/13/21 for 1 day. She returned on comfort care/hospice, and expired on 9/17/21.
Extreme weakness and heart palpitations. Saw my primary care doctor on 1/28/21. Weakness and fatigue got worse and went to an emergency room on 2/2/21. Given a referral to a cardiologist and discharged. Symptoms progressed and went in to the ER again 2/22/21. Kept overnight, released and told to follow up with my cardiologist. Cardiologist had me wear a 2 week heart monitor from 3/1/21 to 3/15/21. Results of heart monitor had the cardiologist refer me to see a heart rhythm doctor. Dr. , heart rhythm cardiologist diagnosed me with Autosomal Dysfunction.
Information has been received from a consumer concerning her 6 month old niece who was vaccinated with pneumococcal vaccine 23 polyvalent 0.5 cc. Subsequently the patient was red, had a fever, and was lethargic. Unspecified medical attention was sought. Additional information has been requested.
Patient seated in observation and completed 15 minutes when she started to c/o throat swelling and difficulty breathing. SP02 100% BP 144/80, HR 82. Patient then started to c/o chest pain. Given Benadryl and RRT was called
backache in kidney went away after receiving vaccine; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (She had backache in her kidneys for 2 weeks and today 02Feb2021 she received the vaccine) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included Back ache (had backache in her kidneys for 2 weeks.).    On 02-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (She had backache in her kidneys for 2 weeks and today 02Feb2021 she received the vaccine). On 03-Feb-2021, BACK PAIN (She had backache in her kidneys for 2 weeks and today 02Feb2021 she received the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included Thyroid medication and, water pills to make urinate.
Pt stated swelling in the left supra clavicular ore, a small amount of pain noticed as well, the symptoms lasted five days, no treatment was needed.
wake in night; General malaise; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (wake in night), MALAISE (General malaise), CHILLS (Chills) and PYREXIA (Fever) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Ciprofloxacin), Drug allergy (Levaquin), Blood pressure high and Osteoporosis. Concomitant products included OLMESARTAN from 15-Aug-2018 to an unknown date for Blood pressure high, DENOSUMAB (PROLIA) from 01-Jun-2018 to an unknown date and CALCIUM for Osteoporosis.   On 17-Jan-2021 at 12:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021 at 12:45 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021 at 1:00 AM, the patient experienced SLEEP DISORDER (wake in night). 15-Feb-2021 at 1:00 AM, the patient experienced MALAISE (General malaise), CHILLS (Chills) and PYREXIA (Fever). On 16-Feb-2021, SLEEP DISORDER (wake in night), MALAISE (General malaise), CHILLS (Chills) and PYREXIA (Fever) had resolved.            The patient took Tylenol, slept and felt okay.   This case was linked to MOD-2021-025359, MOD-2021-025359 (Patient Link).
Blisters head of penis resembling herpes simplex 2  for about 10 days, seems to be getting better  No history of herpes Childhood chicken pox, measles, mumps, german measles
No adverse event; A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No adverse event) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 014F21A, 030L20A and 025L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022).    No concomitant medicine were reported. Lot number 004M21A, expiration date 13Jul2022. Date of administration of vaccine were - 26Jul2022 (40 doses), 04Aug2022 (1 dose), 19Aug2022 (1 dose), 30Sep2022 (1 dose). No treatment medicine were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:Master Case
Tired,  body aches,   Fever,  chills,  soreness at injection site
Spoke with mom. Patient had vaccines yesterday. Temp today 99.9, headaches. Noticed today that she has shooting pains down legs 9/10 and arms 3/10 Off and on throughout day today.
There is consistent pain on the left side of my chest right above my breast. I have random  pains that shoot up my left and my right arm.  I constantly have headaches throughout the day. I?m also experiencing numbness on my tongue.
Patient stated she had significant swelling at the injection site, she felt sick and broke out in rash (didn't specify whether it's around injection site or whole body, stated she couldn't remember). Patient said her doctor thinks she might have gotten shingles from the shot and advised her not to get the second dose. WHen asked if patient developed fever after the vaccine, she stated no
Arm hurt; A spontaneous report was received from a consumer concerning a 52-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm hurt.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 11 Feb 2021, the patient experienced the event(s) arm hurt.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  On 13 Feb 2021 the outcome of event(s), arm hurt was resolved.  Based on comment arm hurt was changed to vaccination site pain and listed in all RSI
Day after second shot I was in bed all day and felt extremely tired, slept a lot. Starting about a week after second shot I had pain in my right arm muscle which moved to my left arm muscle and than to right side jaw muscle, than to back of neck, back of head and spine. When the pain was in my jaw I could not even close my mouth. The pain in all muscles was so bad.  I could not turn my neck to the left. I could not lie on my back at night as the pain on the lower back part of my head felt like a bad sore. My arm muscles were spasms and would automatically drop and go limp when I tried to raise them. I had to take days off from work and miss my family vacation. The pain comes and goes since the shot. I had two urgent care visits and multiple doctor visits and one x ray of the neck
"Patient was walking down the hallway then leaned forward and fell to her knees. She then started jerking in her upper body and seemed dazed" per Dr.
LEG PAIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included does not take blood thinner. patient's father lost legs to blood clot.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch number. No concomitant medications were reported.  On 07-APR-2021, the subject experienced leg pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from leg pain on APR-2021. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious
Narrative:  Pt. received pfizer second vaccine. Reported feeling dizziness. Water given and symptoms improved. Vital signs stable.
When I woke up at 8:00 am I felt fine besides tenderness on arm at injection site and pounding headache. I went back to bed and when I woke up at 9:30 am I felt very sick - worst chills I've ever had but my head felt so hot. I took my temp and I clocked in at 95.4 - getting dangerously low. I took a nap wrapped up in my heated blanket and an hour later took my temp again and was still at 95.4. Then I took a 4 hour nap and when I woke up my temp was a low-grade fever of 99.8. I experienced these same symptoms (even worse) for the 2nd dose, but the temp at almost hypothermic level was what I was most concerned about and why I'm reporting.
the  MMR was expired by 3 weeks. So far there is no reaction patient felt fine after 30 minutes waiting in waiting room. Called mother and patient back into room and explained what happened. That I would call her when needing to repeat MMR and how many days needed to wait. Mother was fine and very understanding