chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3 to 5 minutes after intramuscular; injections of PEDIARIX and PREVNAR vaccines to anterior and lat sides of left thigh, patient's left thigh became warm, erythematous with hives, no blisters, no cyanotic, spreaded down to whole left leg, about 10 minutes later the whole leg looked similar. Patient remained awake alert, crying with no acute distress.
About two weeks after receiving the vaccine the lymph nodes in my neck began to swell.  I was put on amoxicillin for 20 days.  When the swollen nodes didn't get better i was sent to a ER and Thoraxic  Surgeon.  I will be getting a biopsy on 3/5/2021.
Large Painful swollen area on arm, about the size of an orange. Extreme dizzyness and fatique. TRouble sleeping because  it was so sentitive to touch and even clothes.
The patient broke out in hives  and rash around the site of the vaccine yesterday about an hour after administration. Hives continued to spread throughout the body. This morning her right eye was swollen shut on waking but has since gone down. No itchy irritation in the mouth, difficulty swallowing or breathing. Eating and drinking, good energy, sttn. Using benedryl every 6 hours. Prescribed steroids
Patient had been seizure free since 2017 but 1 day after each vaccination, patient had a seizure. Then on May 5th 2021, patient had a breakthrough seizure.
The vaccine expired on 11/25 due to the day it was pulled from the freezer. The patient tolerated the vaccine well and was monitored x 15 minutes.
12:30 pm - Numbness to roof of mouth, upper lip swelling, tongue swelling/tingling 12:45 pm - 2 tabs Allegra taken (180 mg each??) 2:30 pm - Swelling subsided 4:30 pm - Upper lip swelling returned 5:00 pm - Additional 2 tabs of Allegra taken  Reaction stopped at 6:30pm.
Patient presented with urticarial rash on Day 4 of the administration- it started from the right forearm and spread throughout the body. The rash is round to linear, slightly elevated, blanching, pruritic. No vesicles, bulla, discharge, bleeding. No target rashes. No swelling of lips, puffiness of face/eyes. No wheezing, dyspnea, recurrent vomiting. Child appears well comfortable except itching. No concurrent h/o fever. There is mild cough which he has had for 1 week or more which hasn't worsened.
Patient tested positive for Epstein Barr virus on 3/11/2021 Dose #1 of vaccine 1/25/2021 Dose #2 of Vaccine 2/15/2021
HPV; This spontaneous report was received from a consumer via company representative referring to a female patient around 28 years old. The patient's concomitant medication, pertinent medical history and drug allergies and reactions were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (strength, exact dose, injection site, route of administration, lot # and expiration date were not reported) for prophylaxis (she was unsure which vaccine was given).  On an unknown date, the patient had human papillomavirus (HPV) which was not covered by the vaccine.   The outcome of HPV was unknown. The causality assessment between the event and suspect vaccines was not provided by the reporter.   This is one of the three cases received from the same reporter.; Sender's Comments:  US-009507513-2101USA003845: US-009507513-2011USA010820:
Lower legs felt tired and sore., muscle pain. Progressively got worse over the month of February making it nearly impossible to bend, raise and lower myself. Saw my personal doctor on March 1st. He does not think it is vaccine related. Rans some bloodwork tests. Put me on Prednisone for 3 weeks. That did alleviate the muscle soreness/stiffness  but that seems to be starting to return now that I am no longer taking it. Have a Dr. appointment with a Rhuematologist on Friday 3/26/2021.
17 years of age, were inadvertently administered the Moderna COVID-19 Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years of age, were inadvertently administered the Moderna COVID-19 Vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years of age, were inadvertently administered the Moderna COVID-19 Vaccine). On 03-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years of age, were inadvertently administered the Moderna COVID-19 Vaccine) had resolved. Not Provided      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 product use was not provided by the reporter.  The patient did not experience any adverse event symptoms and no treatment was administered.  This report refers to a case of product administered to patient of inappropriate age, for mRNA-1273, lot #: 016B21A,  with no associated AEs.   This case was linked to US-MODERNATX, INC.-MOD-2021-067510, US-MODERNATX, INC.-MOD-2021-067198, US-MODERNATX, INC.-MOD-2021-067547, US-MODERNATX, INC.-MOD-2021-067645, US-MODERNATX, INC.-MOD-2021-067217 (E2B Linked Report).; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age, for mRNA-1273, lot #: 016B21A,  with no associated AEs. US-MODERNATX, INC.-MOD-2021-067510:Crosslinked cases US-MODERNATX, INC.-MOD-2021-067198:Crosslinked cases US-MODERNATX, INC.-MOD-2021-067547:Crosslinked cases US-MODERNATX, INC.-MOD-2021-067645:Crosslinked cases US-MODERNATX, INC.-MOD-2021-067217:Crosslinked cases
Pt had a red spot/bruise that was warm to touch and itchy. Pharmacist recommended pt apply hydrocortisone cream to the area and take Claritin. Pt stated that the hydrocortisone cream helped with the itching but the size of the bruise continues to get bigger.
Arm  was sore; Body was aching; hot; Red; Felt a little sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt a little sick), VACCINATION SITE WARMTH (hot), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE PAIN (Arm  was sore) and MYALGIA (Body was aching) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Codeine).   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced MALAISE (Felt a little sick). On 24-Feb-2021, the patient experienced VACCINATION SITE WARMTH (hot), VACCINATION SITE ERYTHEMA (Red) and MYALGIA (Body was aching). On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm  was sore). At the time of the report, MALAISE (Felt a little sick), VACCINATION SITE WARMTH (hot), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE PAIN (Arm  was sore) and MYALGIA (Body was aching) outcome was unknown. Not Provided          No concomitant was provided. Patient treatment information was not provided.
Received 1st MMR on 01/24/2005. Reports mother, (today 02/21/2005) states she experienced swelling in L. elbow within the hour followed by swollen glands that night. The following day she experienced pain in her ankles and wrists. No fever. Seen by private medical doctor who states she should not have another MMR. Adverse event not reported to ASU until today. Encouraged to have blood titer.
While being administering the vaccine, the injection site burned terribly. About 3-4 hours later, I was hit like a ton of bricks with extreme muscle weakness and aching, joint aching, inability to keep temperature up (chattering teeth/icy hands despite being under 4 blankets), moderate headaches, mild nausea, vomited once. Day 1 I felt horrendous: like the worst flu ever. Day 2 I will still unable to get out of bed but was feeling somewhat better. Felt substantially better by Day 3 but injection site was still swollen, red and angry looking for days. A miserable experience! Worst vaccine I have ever had in my life. No preparation for this by the pharmacist. I'm afraid to take Vaccine # 2!
Fatigue, trouble breathing, heart racing, weight loss 6/2/21 - Doctor visit-fatigue, breathing issues.  Prescribed meds for sinus infection 6/7/21 - Doctor visit-shaking, fatigue, heart pounding, weight loss.  Ordered bloodwork, xray of lunbs 6/17/21 - Doctor visit-follow up - reviewed bloodwork.  Prescribed meds for thyroid issue.  Ordered electrocardiogram & ultrasound of thyroid 6/29/21 - Specialist visit - reviewed bloodwork.  Did ultrasound in office.  Follow up visit in 3-4 hours and bloodwork 7/16/21 - Specialist visit - reviewed bloodwork.  Quadrupled medication.  Follow up visit in 3-4 hours and bloodwork 8/4/21 - Doctor visit - follow up to discuss thyroid issue 8/16/21 - Specialist visit - reviewed bloodwork.  Follow up visit in 3-4 hours and bloodwork
Pain; Chills; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), CHILLS (Chills) and MYALGIA (Body Aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Pain), CHILLS (Chills) and MYALGIA (Body Aches). At the time of the report, PAIN (Pain), CHILLS (Chills) and MYALGIA (Body Aches) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant Medication not provided by the reporter.  Treatment information was not provided by the reporter.
Antibody test negative; Second Moderna vaccine on 3-12-2021; A Spontaneous case  was reported by a health care professional, concerning a female who received Moderna COVID-19 Vaccine (mRNA-1273) and describe the occurrence of second Moderna vaccine on 3-12-2021, antibody test negative.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 26-feb-2021, the patient started taking first dose of Moderna COVID-19 Vaccine (mRNA-1273) Intramuscularly for prophylaxis of COVID-19 Infection.   On 12-Mar-2021, the patient received second dose of mRNA-1273. On 23-mar-2021, the patient experienced Antibody test negative.  Treatment for the events were not specified.  Action taken with mRNA-1273 in response to the event was not provided.  The events, second Moderna vaccine on 3-12-2021, antibody test negative, was considered unknown.; Reporter's Comments: This report refers to a case of inappropriate schedule of product administration and antibody test negative, for mRNA-1273, lot # unknown,  with no associated AEs.
This spontaneous report as received on 02-MAR-2017 from a female healthcare worker (Not further specified if a healthcare professional), refers to 10 patients (age and gender not reported) who received unspecified doses in VARIVAX (Lot number M033905, expiration date 20-JUL-2018) immunization series that were improperly stored.  The site and route of VARIVAX administration were not reported.  The vaccinations occurred between 22-FEB-2017 and 01-MAR-2017. The vaccines were exposed to temperature of 18.5F (Fahrenheit) for a time frame of 5.3 hours.  There were no previous temperature excursions reported. The temperature excursion was recorded by a data logger. The patients' pertinent medical history, concomitant medications and drug allergies were not reported. It was further specified that on 01-MAR-2017, this patient (age and gender not reported) received administration of VARIVAX. No adverse effects were reported. There was no product quality complaint involved. No further information was provided. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA001788:
Woke up the morning of 8/14/2021 and both legs were stiff and swollen. There was fluid in both knees and thighs. The pain was extreme. Pain lasted for almost 4 weeks, but patient still does not feel fully back to normal. Still has some stiffness and swelling in the legs.
WEAKNESS .  HPI  PT WAS FOUND HAVING CHANGE IN MENTAL STATUS AT DAY CARE CENTER
This is one of four reports. A 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 12Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced Pain and tenderness at injection site on 12Apr2021. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Janssen COVID-19 Vaccine EUA I felt fine after the vaccine until that same night when my chest and neck started aching and I developed a strong headache.  Ibuprofen made the aches better but the headache continued until morning and throughout the night I was unable to sleep.  The following morning I have a slight fever and some minor aches.
After being cllinically well, pt was found asystolic w/o respiration; this was felt to be SIDS; resusitation was begun & pt brough to ER; over next 2-3 days pt showed evidence of severe neuro damage & multiple organ failure;
NOT REPORTING ADVERESE EVENT.  ADMIISTRATION ERROR- PATIENT RECEIVED A 2ND BOOSTER DOSE (25 YO) 84 DAYS AFTER 1ST BOOSTER DOSE. PATIENT CAME IN TO GET BOOSTER DOSE PFIZER; PATIENT STATED DURING CONSULT HE RECIEVED HIS PRIMARY SERIES APRIL 2021; PATIENT CONFIRMED >5 MONTHS FROM LAST SHOT OF PRIMARY SERIES. IMMUNIZATION REGISTARY RECORD SHOWED  PATIENT RECIEVED ONE PFIZER DOSE ON (1OF2) ON 4/4/22; AFTER ADMINISTRATION CALLED PATIENT TO DISCUSS WHEN BOOSTER DUE; PATIENT THEN DISCLOSED HE RECENTLY HAD A NAME CHANGE. PER IMMUNIZATION REGISTRY PRIMARY SERIES PFIZER WAS GIVEN ON 1/25/21 & 2/15/22. INFORMED PATIENT 2ND BOOSTER WAS GIVEN IN ERROR
3RD DOSE COVID VACCINE, MODERNA GIVEN 05/26/2022, #057M21A pt resides in SNF, Life Care Center;  pt had a positive COVID test in the facility on 8/25/22; pt passed away in the facility
HA, muscle aches, dizziness, soreness at injection site, mild nausea
Tiny bit sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Tiny bit sore arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 032B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATENOLOL and OLMESARTAN for Blood pressure high, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (Tiny bit sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Myalgia, at an unspecified dose and frequency. On 01-May-2021, MYALGIA (Tiny bit sore arm) had resolved.            Concomitant medication included Diuretic 25mg and also an unknown BP med. Patient stated that she takes 3 BP medications.   This case was linked to MOD-2021-163836 (Patient Link).
1 night and one day of low fever, aches and sweating. "Moderna Arm"--baseball sized (perimeter) slightly raised red and hot hive/inflammation at site of injection - gradually subsided over course of one week.  one regular menstrual period post vaccination. Followed by one delayed and irregular menstrual cycle (ten days late, heavy, prolonged , spotty). Have had extremely regular cycles until now - first ever delayed.
Had seizure-like activity (had rhythmic tremors and eyes rolled to back of head) lasting about 3 seconds (according to mother).
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 42 years 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: "Crohn's disease" (unspecified if ongoing); "Latex allergy" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA, start date: 01Oct2018. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with Paxlovid started on 21Dec2022 and stopped on 26Dec2022.
administered with expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The pharmacist stated that they inadvertently administered and expired dose of the Moderna Covid-19 vaccine to 18 patients - 9 doses administered on 09May2022 and 9 doses administered on 11May2022. Lot number 084J21A;expiration 05May2022. No patient has reported adverse reaction No treatment medication were provided.
When I got home I was having difficulty breathing. I was wheezing and was coughing at a lot. I thought it was allergies. After about 2 hours this went away. 6/8/2012 I went to pharmancy and showed the pharmacist my welt on my arm. I told her it was itchy since I first received the shot. She told me to report it. The welt was about the size of my finger tip. I also was sick to my stomach and had 1 case of diarrhea.  6/9/12 My arm was really sore today. The welt is now about the size of a 50 cent piece. No other reactions. I have a bad local reaction to most things so I'm going to wait 72 hours of see if the welt gets bigger. Any other symptoms I will go straight to the hospital.
On 2/25/2021 at about 5:00 AM, my neck wouldn't turn. Normally, I was able to turn with no problem beforehand. It was like it was locked in place. I had to move my whole body to see to the side. The lymph nodes on both the left and the right of the neck were swollen, and they hurt when I touched them. My lymph nodes are still swollen, and the severity varies from day to day. My neck is still not as flexible as it was before 2/25, but it's much better now. I would say that I have regained about 80% of my movement. I went to Dr. on 4/1/2021. He said I should keep exercising my neck, which I have done, and he referred me for a scan. The scan indicated that there was a mass in the swollen lymph nodes, but they weren't cancerous.
Severe migraine; Nausea; Abdominal cramping; Burning skin rash on face & chest & hot to touch purple rash on both arms below injection site; Burning skin rash on face & chest & hot to touch purple rash on both arms below injection site; Skin sensitivity with itching burning sensation over most of body; Skin sensitivity with itching burning sensation over most of body; Skin sensitivity with itching burning sensation over most of body; Chest congestion; Cough; Esophageal spasm; Trouble swallowing; Diarrhea; Chills; Fever; Fatigue; Bone & muscle pain; Bone & muscle pain; Emotional upset; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 08Apr2021 at 12:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and lyme disease. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 08Mar2021 at 13:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. On 08Apr2021 at 18:00, the patient experienced severe migraine, nausea and abdominal cramping, burning skin rash on face and chest and hot to touch purple rash on both arms below injection site, skin sensitivity with itching burning sensation over most of body, chest congestion and cough, esophageal spasm and trouble swallowing, diarrhea, chills, fever, fatigue, bone and muscle pain and emotional upset. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe migraine, nausea, abdominal cramping, burning skin rash on face and chest and hot to touch purple rash on both arms below injection site, skin sensitivity with itching burning sensation over most of body, chest congestion, cough, esophageal spasm, trouble swallowing, diarrhea, chills, fever, fatigue, bone and muscle pain and emotional upset was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Dizziness, Rash, UrticariaPruritus, & Urticaria; diaphoresis
Malaise; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise) and HEADACHE (Headache) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (Malaise) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise) and HEADACHE (Headache) outcome was unknown.        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.   No Concomitant product use was reported. No treatment information was provided.    This case was linked to MOD-2021-370217 (Patient Link).